REACH Regulation (EC) No 1907/2006 EN

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REACH Regulation (EC) No 1907/2006 EN

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3. 30.12.2006 EN Official Journal of the European Union L 396/3 (5) This Regulation should apply without prej udice to Community workplace and environment legislation. (6) This Regulation should contri bute to fulfilment of the Strate gic Approach to International Chemical Management (SAICM) adopted on 6 February 2006 in Dubai. (7) To preserve the integrity of the internal ma rket and to ensure a hi gh level of protection for human health, especially the health of worker s, and the environment, it is necessary to ensure that manufacturing of substances in the Community complies with Community law, even if those substances are exported. (8) Special account should be taken of the poten tial impact of this Regulation on small- and medium-sized enterprises (SME s) and the need to avoid an y discrimination against them.

7. 30.12.2006 EN Official Journal of the European Union L 396/7 (15) There is a need to ensure effective management of the technical, scientific and administrative aspects of this Regulation at Community level. A central entity should therefore be created to fulfil this role. A feasibility study on the resource requirements for this central entity concluded that an indepe ndent central entity offered a number of long-term advantages over other options. A European Chemicals Agency (hereinafter referred to as "the Agency") s hould therefore be established. (16) This Regulation lays down specific duties and obligations on manufacturers, importers and downstream users of substances on their own, in preparations and in articles. This Regulation is based on the pr inciple that industry should manufacture, import or use substances or place them on the market w ith such responsibilit y and care as may be required to ensure that, under reasonably fo reseeable conditions, human health and the environment are not adversely affected. (17) All available and relevant information on substances on their own, in preparations and in articles should be collected to assist in identifying hazardous properties, and recommendations about risk management m easures should systematically be conveyed through supply chains, as reasonably necessary, to prevent adverse effects on human health and the environment. In addition, communica tion of technical advice to support risk management should be encouraged in the supply chain, where appropriate. (18) Responsibility for the management of the risk s of substances should li e with the natural or legal persons that manufacture, import, place on the market or use these substances. Information on the implementation of this Regulation should be eas ily accessible, in particular for SMEs.

8. L 396/8 EN Official Journal of the European Union 30.12.2006 (19) Therefore, the registration provisions s hould require manufacturers and importers to generate data on the substances they manufactur e or import, to use these data to assess the risks related to these substances and to develop and recommend appropriate risk management measures. To ensure that they ac tually meet these obligations, as well as for transparency reasons, registration should requ ire them to submit a dossier containing all this information to the Agency. Registered s ubstances should be allowed to circulate on the internal market. (20) The evaluation provisions should provide for follow-up to registration, by allowing for checks on whether registrations are in complian ce with the requirements of this Regulation and if necessary by allowing for generation of more information on the properties of substances. If the Agency in cooperation with the Member States considers that there are grounds for considering that a substance cons titutes a risk to human health or the environment, the Agency should, after havi ng included the substance in the Community rolling action plan for subs tance evaluation, relying on th e competent authorities of Member States, ensure that this substance is evaluated. (21) Although the information yielded on substanc es through evaluation should be used in the first place by manufacturers and importers to ma nage the risks related to their substances, it may also be used to initiat e the authorisation or restrictions pr ocedures under this Regulation or risk management procedures under other Community legislation. Therefore it should be ensured that this information is available to the compet ent authorities and may be used by them for the purpose of such procedures.

9. 30.12.2006 EN Official Journal of the European Union L 396/9 (22) The authorisation provisions should ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled. Authorisations for the placing on the market and use should be granted by the Commission only if the risks arising from their use are ade quately controlled, where this is possible, or the use can be justified for socio-economi c reasons and no suitable alternatives are available, which are economically and technically viable. (23) The restriction provisions should allow the manufacturing, placing on the market and use of substances presenting risks th at need to be addressed, to be made subject to total or partial bans or other restrictions, ba sed on an assessment of those risks. (24) In preparation for this Regulation, th e Commission has launched REACH Implementation Projects (RIPs), involving relevant expert s from stakeholder groups. Some of those projects aim at developing draft guidelines and tools which should help the Commission, the Agency, Member States, manufacturers, impor ters and downstream users of substances to fulfil, in concrete terms, their obligations under this Regulation. This work should enable the Commission and the Agency to make available appropriate technical guidance, in due time, with regard to the d eadlines introduced by this Regulation.

10. L 396/10 EN Official Journal of the European Union 30.12.2006 (25) The responsibility to asse ss the risks and hazards of subs tances should be given, in the first place, to the natural or legal persons th at manufacture or import substances, but only when they do so in quantities exceeding a cert ain volume, to enable them to carry the associated burden. Natural or legal persons handling chemicals should take the necessary risk management measures in accordance with the assessment of the risks of substances and pass on relevant recomm endations along the supply chain. This should include describing, documenting and notifying in an appr opriate and transparen t fashion the risks stemming from the production, use a nd disposal of each substance. (26) In order to undertake chemical safety asse ssments of substances effectively, manufacturers and importers of substances should obtain in formation on these substa nces, if necessary by performing new tests. (27) For purposes of enforcement and evalua tion and for reasons of transparency, the information on these substances, as well as related information, including on risk management measures, should normally be submitted to authorities.

11. 30.12.2006 EN Official Journal of the European Union L 396/11 (28) Scientific research and development nor mally takes place in quantities below 1 tonne per year. There is no need to exempt such research and development because substances in those quantities do not have to be registered in any case. Ho wever, in order to encourage innovation, product and process or iented research and develo pment should be exempted from the obligation to register for a certai n time period where a substance is not yet intended to be placed on the market to an indefinite number of customers because its application in preparations or articles stil l requires further research and development performed by the potential registrant himsel f or in cooperation with a limited number of known customers. In addition, it is appropriate to provide for a similar exemption to downstream users using the substance for th e purposes of product and process oriented research and development, provi ded that the risks to human h ealth and the environment are adequately controlled in accord ance with the requirements of legislation for the protection of workers and the environment. (29) Since producers and importer s of articles should be respons ible for their articles, it is appropriate to impose a registration requireme nt on substances which are intended to be released from articles and have not been registered for that use. In the case of substances of very high concern which are present in articles above tonnage and concentration thresholds, where exposure to the substance cannot be excluded and where the substance has not been registered by any person for this use, the Agency should be notified. The Agency should also be empowered to request that a registration be submitted if it has grounds for suspecting that the release of a subs tance from the article may present a risk to human health or the environment and the substa nce is present in thos e articles in quantities totalling over 1 tonne per producer or importe r per year. The Agency should consider the need for a proposal for a restriction where it c onsiders that the use of such substances in articles poses a risk to human health or the environment that is not adequately controlled.

12. L 396/12 EN Official Journal of the European Union 30.12.2006 (30) The requirements for unde rtaking chemical safety assessments by manufacturers and importers should be defined in detail in a te chnical annex to allow them to meet their obligations. To achieve fair burden sharing with their customers, manufacturers and importers should in their chemical safety a ssessment address not onl y their own uses and the uses for which they place their substances on the market, but also all uses which their customers ask them to address. (31) The Commission, in close cooperation with industry, Member States and other relevant stakeholders, should develop guidance to fu lfil the requirements under this Regulation related to preparations (in particular with regard to safety data sheets incorporating exposure scenarios) including assessment of substances incorporated into special preparations – such as metals incorporated in alloys. In doing so, the Commission should take full account of the work that will have been carried out within the framework of the RIPs and should include the necessary guidance on this matter in the overall REACH guidance package. This guidance should be av ailable before the application of this Regulation. (32) A chemical safety assessment should not need to be performed for substances in preparations in certain very small concentratio ns which are considered as not giving rise to concern. Substances in preparations in such low concentrations should also be exempt from authorisation. These provi sions should apply equally to preparations that are solid mixtures of substances until a specific shape is given to such a preparation that transforms it into an article.

13. 30.12.2006 EN Official Journal of the European Union L 396/13 (33) Joint submission and the sh aring of information on substances should be provided for in order to increase the efficiency of the registration system, to reduce costs and to reduce testing on vertebrate animals. One of a group of multiple registrants should submit information on behalf of the others according to rules which ensure that all the required information is submitted, while allowing shari ng of the costs burden. A registrant should be able to submit information directly to the Agency in certain specified cases. (34) Requirements for generation of information on substances should be tiered according to the volumes of manufacture or importation of a s ubstance, because these provide an indication of the potential for exposure of man and the environment to the subs tances, and should be described in detail. To reduce the possi ble impact on low volume substances, new toxicological and ecotoxicological informa tion should only be required for priority substances between 1 and 10 tonnes. For othe r substances in that quantity range there should be incentives to encourage manufacturers and importers to provide this information. (35) The Member States, the Agency and all inte rested parties should take full account of the results of the RIPs, in particul ar with regard to the registra tion of substances which occur in nature. (36) It is necessary to consider the applica tion of Article 2(7)(a) and (b) and Annex XI to substances derived from mineralogical proc esses and the review of Annexes IV and V should fully take this into account.

16. L 396/16 EN Official Journal of the European Union 30.12.2006 (44) In order to provide a harmonised, simple system, all registrations should be submitted to the Agency. To ensure a consistent approach and efficient use of resources, it should perform a completeness check on all registrations and take responsibility for any final rejections of registrations. (45) The European Inventory of Existing Commercial Chemical Substances (EINECS) included certain complex substances in a single en try. UVCB substances (substances of unknown or variable composition, complex reac tion products or biological ma terials) may be registered as a single substance under this Regulation, despite their variable composition, provided that the hazardous properties do not differ significantly and wa rrant the same classification. (46) To ensure that the information gathered through the registration is kept up-to-date, an obligation on registrants to inform the Agency of certain changes to the information should be introduced.

17. 30.12.2006 EN Official Journal of the European Union L 396/17 (47) In accordance with Directive 86/609/EEC, it is necessary to replace, reduce or refine testing on vertebrate animals. Implementati on of this Regulation should be based on the use of alternative test methods , suitable for the assessment of health and environmental hazards of chemicals, wherever possible. The use of animals should be avoided by recourse to alternative met hods validated by the Commission or international bodies, or recognised by the Commission or the Agency as appropriate to meet the information requirements under this Regulation. To this end, the Commission, following consultation with relevant stakeholders, should propose to amend the future Commission Regulation on test methods or this Regulation, where approp riate, to replace, redu ce or refine animal testing. The Commission and the Agency should ensure that reduction of animal testing is a key consideration in the development and ma intenance of guidance for stakeholders and in the Agency's own procedures. (48) This Regulation should be without prejudice to the full a nd complete application of the Community competition rules. (49) In order to avoid duplication of work, and in particular to reduce testing involving vertebrate animals, the provisions concerning preparation and submission of registrations and updates should require sharing of informati on where this is request ed by any registrant. If the information concerns vert ebrate animals, the registrant should be obliged to request it.

18. L 396/18 EN Official Journal of the European Union 30.12.2006 (50) It is in the public interest to ensure the quickest possible circul ation of test results on human health or environmental hazards of cer tain substances to those natural or legal persons which use them, in order to limit any risks associated with their use. Sharing of information should occur where th is is requested by any registra nt, in particular in the case of information involving tests on vertebrate animals, under conditions that ensure a fair compensation for the company th at has undertaken the tests. (51) In order to strengthen the competitiveness of Community industry and to ensure that this Regulation is applied as efficiently as possible, it is a ppropriate to make provision for the sharing of data between registrants on the basis of fair compensation. (52) In order to respect the legitimate property rights of those generating testing data, the owner of such data should, for a period of 12 years, be able to claim compensation from those registrants who benefit from that data. (53) In order to allow a poten tial registrant of a phase-in s ubstance to proceed with his registration, even if he cannot reach agreemen t with a previous registrant, the Agency, on request, should allow use of any summary or robust study summary of tests already submitted. The registrant who receives these da ta should be obliged to pay a contribution to the costs to the owner of the data. For non-phase-in substa nces, the Agency may ask for evidence that a potential registra nt has paid the owner of a study before the Agency gives permission for the potential registrant to use that information in his registration.

19. 30.12.2006 EN Official Journal of the European Union L 396/19 (54) In order to avoid duplication of work, and in particular to avoi d duplication of testing, registrants of phase-in substances should pre-register as early as possible with a database managed by the Agency. A system should be established in order to provide for the establishment of Substance Information Exch ange Fora (SIEF) to help exchange of information on the substances that have been registered. SIEF partic ipants should include all relevant actors submitting information to the Agency on the same phase-in substance. They should include both potenti al registrants, who must provi de and be supplied with any information relevant to the registration of th eir substances, and othe r participants, who may receive financial compensation for studies th ey hold but are not entitled to request information. In order to ensure the smooth f unctioning of that system they should fulfil certain obligations. If a member of a SIEF does not fulfil his obligations, he should be penalised accordingly but other members shoul d be enabled to continue preparing their own registration. In cases where a substance ha s not been pre-registered, measures should be taken to help downstream users find alternative sources of supply. (55) Manufacturers and importers of a substan ce on its own or in a preparation should be encouraged to communicate with the downstrea m users of the substance with regard to whether they intend to register the substance. Such inform ation should be provided to a downstream user sufficiently in advance of the relevant registration deadline if the manufacturer or importer does not intend to regi ster the substance, in order to enable the downstream user to look for a lternative sources of supply.

20. L 396/20 EN Official Journal of the European Union 30.12.2006 (56) Part of the responsibility of manufacturers or importers for the management of the risks of substances is the communication of informati on on these substances to other professionals such as downstream users or distributors. In addition, producers or importers of articles should supply information on the safe use of ar ticles to industrial and professional users, and consumers on request. This important resp onsibility should also apply throughout the supply chain to enable all actors to meet thei r responsibility in rela tion to management of risks arising from the use of substances. (57) As the existing safety data sheet is alrea dy being used as a communication tool within the supply chain of substances and preparations, it is appropriate to develop it further and make it an integral part of the sy stem established by this Regulation. (58) In order to have a chai n of responsibilities, downstream users should be responsible for assessing the risks arising from their uses of substances if those uses are not covered by a safety data sheet received from their supplie rs, unless the downstream user concerned takes more protective measures than those recomm ended by his supplier or unless his supplier was not required to assess t hose risks or provide him with information on those risks. For the same reason, downstream users should manage the risks arising from their uses of substances. In addition, it is appropriate th at any producer or importer of an article containing a substance of very high concern s hould provide sufficient information to allow safe use of such an article.

21. 30.12.2006 EN Official Journal of the European Union L 396/21 (59) The requirements for unde rtaking chemical safety assessments by downstream users should also be prescribed in detail to a llow them to meet their obligations. These requirements should only apply above a total quantity of 1 tonne of substance or preparation. In any case, how ever, the downstream users sh ould consider the use and identify and apply appropriate risk manage ment measures. Downstream users should report certain basic information on use to the Agency. (60) For enforcement and evaluation purposes, downstream users of substances should be required to report to the Agency certain basi c information if their use is outside the conditions of the exposure scenario detailed in the safety data sheet communicated by their original manufacturer or importer and to k eep such reported information up-to-date. (61) For reasons of workability and proportiona lity, it is appropriat e to exempt downstream users using low quantities of a substance from such reporting. (62) Communication up and down the supply ch ain should be facili tated. The Commission should develop a system categorising brief gene ral descriptions of uses taking into account the outcomes of the RIPs. (63) It is also necessary to ensu re that generation of information is tailored to real information needs. To this end evaluation should require the Agency to decide on the programmes of testing proposed by manufactur ers and importers. In cooperation with Member States, the Agency should give priority to certain substanc es, for instance those which may be of very high concern.

22. L 396/22 EN Official Journal of the European Union 30.12.2006 (64) In order to prevent unnece ssary animal testing, interested parties should have a period of 45 days during which they may provide scientif ically valid information and studies that address the relevant substance and hazard en d-point, which is addressed by the testing proposal. The scientifically valid informati on and studies received by the Agency should be taken into account for deci sions on testing proposals. (65) In addition, it is necessary to instil confidence in the general quality of registrations and to ensure that the public at large as well as all stakeholders in the chemicals industry have confidence that natural or legal persons are meeting the obligations placed upon them. Accordingly, it is appropriate to provide for recording which information has been reviewed by an assessor po ssessing appropriate e xperience, and for a percentage of registrations to be checked for compliance by the Agency. (66) The Agency should also be empowered to require further informa tion from manufacturers, importers or downstream users on substances suspected of posing a risk to human health or the environment, including by reason of thei r presence on the internal market in high volumes, on the basis of evaluations perfor med. Based on the criter ia for prioritising substances developed by the Agency in coope ration with the Member States a Community rolling action plan for substan ce evaluation should be estab lished, relying on Member State competent authorities to evaluate substances included therein. If a risk equivalent to the level of concern arising from th e use of substances subject to authorisation arises from the use of isolated intermediates on site, the competent authorities of the Member States should also be allowed to require further information, when justified.

23. 30.12.2006 EN Official Journal of the European Union L 396/23 (67) Collective agreement within the Agency's Member State Committee on its draft decisions should provide the basis for an efficient system that respects the prin ciple of subsidiarity, while maintaining the internal market. If one or more Member States or the Agency do not agree to a draft decision, it s hould be adopted subject to a cen tralised procedure. If the Member State Committee fails to reach una nimous agreement, the Commission should adopt a decision in accordance with a Committee procedure. (68) Evaluation may lead to the conclusion that action should be taken under the restriction or authorisation procedures or th at risk management action s hould be considered in the framework of other appropriate legislati on. Information on the pr ogress of evaluation proceedings should therefore be made public. (69) To ensure a sufficiently high level of prot ection for human health, including having regard to relevant human population groups and possi bly to certain vulne rable sub-populations, and the environment, substances of very high concern should, in accordance with the precautionary principle, be subject to careful attention. Authorisation should be granted where natural or legal persons applying for an authorisation demons trate to the granting authority that the risks to hu man health and the environment arising from the use of the substance are adequately controlled. Otherwise, uses may still be authorised if it can be shown that the socio-economic benefits from the use of the substance outweigh the risks connected with its use and there are no suitabl e alternative substances or technologies that are economically and technically viable. Ta king into account the good functioning of the internal market it is appropriate that th e Commission should be the granting authority.

24. L 396/24 EN Official Journal of the European Union 30.12.2006 (70) Adverse effects on human health and the environment from substances of very high concern should be prevented through the applic ation of appropriate risk management measures to ensure that any risks from the us es of a substance are adequately controlled, and with a view to progressively substituting these substances with a suitable safer substance. Risk management measures should be applied to ensure, when substances are manufactured, placed on the market and used, that exposure to these substances including discharges, emissions and losses, throughout th e whole life-cycle is below the threshold level beyond which adverse effects may occur. For any substance for which authorisation has been granted, and for any other substance fo r which it is not possibl e to establish a safe level of exposure, measures should always be taken to minimise, as far as technically and practically possible, exposure and emissions with a view to minimi sing the likelihood of adverse effects. Measures to ensure adequate control should be identified in any Chemical Safety Report. These measures should be a pplied and, where appropr iate, recommended to other actors down the supply chain. (71) Methodologies to establish thresholds for carcinogenic and mutagenic substances may be developed taking into account the outcomes of RIPs. The relevant Annex may be amended on the basis of these methodologies to allow thre sholds where appropriate to be used while ensuring a high level of protection of human health and the environment.

25. 30.12.2006 EN Official Journal of the European Union L 396/25 (72) To support the aim of eventu al replacement of substances of very high concern by suitable alternative substances or tec hnologies, all applicants for au thorisation should provide an analysis of alternatives consid ering their risks and the techni cal and economic feasibility of substitution, including information on any re search and development the applicant is undertaking or intends to undert ake. Furthermore, authorisa tions should be subject to time-limited review whose periods would be determined on a case-by-case basis and normally be subject to conditions, including monitoring. (73) Substitution of a substance on its own, in a pr eparation or in an article should be required when manufacture, use or placing on the market of that substance causes an unacceptable risk to human health or to the environment, ta king into account the availability of suitable safer alternative substances and technologies, and the socio- economic benefits from the uses of the substance posi ng an unacceptable risk. (74) Substitution of a substance of very high concern by suitable safer alternative substances or technologies should be considered by all those applying for authorisatio ns of uses of such substances on their own, in preparations or fo r incorporation of substa nces into articles by making an analysis of alternatives, the risk s involved in using any alternative and the technical and economic feasib ility of substitution. (75) The possibility of introducing restricti ons on the manufacturing, placing on the market and use of dangerous substances, preparations and articles applies to al l substances falling within the scope of this Regul ation, with minor exemptions. Restrictions on the placing on the market and the use of substances whic h are carcinogenic, muta genic or toxic to reproduction, category 1 or 2, for their use by consumers on their own or in preparations should continue to be introduced.

26. L 396/26 EN Official Journal of the European Union 30.12.2006 (76) Experience at international level shows that substances with charac teristics rendering them persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, present a very high concern, wh ile criteria have been developed allowing the identification of such substances. For certa in other substances c oncerns are sufficiently high to address them in the same way on a case-by-case basis. The criteria in Annex XIII should be reviewed taking into account th e current and any new experience in the identification of these substances and if appr opriate, be amended with a view to ensuring a high level of protection for human health and the environment. (77) In view of workability and practicality c onsiderations, both as regards natural or legal persons, who have to prepare application fi les and take appropriate risk management measures, and as regards the au thorities, who have to proces s authorisation applications, only a limited number of substa nces should be subjected to th e authorisation procedure at the same time and realistic dead lines should be set for applic ations, while allowing certain uses to be exempted. Substances identified as meeting the criteria fo r authorisation should be included in a candidate list for eventual in clusion in the authorisa tion procedure. Within this list, substances on the Agency's work programme should be clearly identified. (78) The Agency should provide advice on the priori tisation of substances to be made subject to the authorisation procedure, to ensure that decisions reflect the needs of society as well as scientific knowledge and developments. (79) A total ban on a substance would mean that none of its uses could be authorised. It would therefore be pointless to allow the submission of applications for authorisa tion. In such cases the substance should be removed from th e list of substances for which applications can be submitted and added to the list of restricted substances.

27. 30.12.2006 EN Official Journal of the European Union L 396/27 (80) The proper interaction between the provision s on authorisation and restriction should be ensured in order to preserve the efficient functioning of the internal market and the protection of human health, safe ty and the environment. Restri ctions that exist when the substance in question is added to the list of substances for which applications for authorisation can be submitted, should be main tained for that substance. The Agency should consider whether the risk from substances in articles is adequately controlled and, if it is not, prepare a dossier in relation to intr oduction of further restrictions for substances for which the use requires authorisation. (81) In order to provide a harmonised approach to the authorisation of th e uses of particular substances, the Agency should issue opinions on the risks arising from those uses, including whether or not the substance is ade quately controlled and on any socio-economic analysis submitted to it by third parties. These opinions should be taken into account by the Commission when considering whether or not to grant an authorisation. (82) To allow effective monitoring and enfo rcement of the authorisation requirement, downstream users benefiting from an authorisat ion granted to their supplier should inform the Agency of their us e of the substance. (83) It is suitable in these ci rcumstances that final decisions gr anting or refusing authorisations be adopted by the Commission pursuant to a re gulatory procedure in order to allow for an examination of their wider implications with in the Member States and to associate the latter more closely with the decisions.

28. L 396/28 EN Official Journal of the European Union 30.12.2006 (84) In order to accelerate the current system the restriction procedure should be restructured and Directive 76/769/EEC, which has been s ubstantially amended and adapted several times, should be replaced. In the interests of clarity and as a starting point for this new accelerated restriction procedure, all the rest rictions developed under that Directive should be incorporated into this Regulation. Where appropriate, the applica tion of Annex XVII of this Regulation should be facilitated by guidance developed by the Commission. (85) In relation to Annex XVII Member States s hould be allowed to main tain for a transitional period more stringent restrictions, provided that these restrictions have been notified according to the Treaty. This should concer n substances on their own, substances in preparations and substances in articles, the manufacturing, the placing on the market and the use of which is restricted. The Commissi on should compile and publish an inventory of these restrictions. This would provide an opportunity for the Commission to review the measures concerned with a vi ew to possible harmonisation. (86) It should be the responsi bility of the manufacturer, im porter and downstream user to identify the appropriate risk management m easures needed to ensure a high level of protection for human health and the envir onment from the manufacturing, placing on the market or use of a substance on its own, in a pr eparation or in an ar ticle. However, where this is considered to be insufficient and where Community legislation is justified, appropriate restrictions should be laid down.

29. 30.12.2006 EN Official Journal of the European Union L 396/29 (87) In order to protect human health and the environment, restricti ons on the manufacture, placing on the market or use of a substance on its own, in a preparation or in an article may include any condition for, or prohibition of, the manufacture, placing on the market or use. Therefore it is necessary to list such restrictions and any amendments thereto. (88) In order to prepare a rest rictions proposal and in order for such legislation to operate effectively, there should be good cooperation, coordination and information between the Member States, the Agency, other bodies of the Community, the Commission and the interested parties. (89) In order to give Member States the oppor tunity to submit proposals to address a specific risk for human health and the environment, they should prep are a dossier in conformity with detailed requirements. The dossier should set out the justification for Community-wide action. (90) In order to provide a harmonised approach to restrictions, the Agency should fulfil a role as coordinator of this procedure, for exampl e by appointing the relevant rapporteurs and verifying conformity with the requirements of the relevant Annexes. The Agency should maintain a list of substances for which a restriction dossier is being prepared. (91) In order to give the Commission the opportuni ty to address a specific risk for human health and the environment that needs to be addre ssed Community wide, it should be able to entrust the Agency with the prep aration of a rest riction dossier.

31. 30.12.2006 EN Official Journal of the European Union L 396/31 (98) In the interests of efficien cy, the staff of the Agency Secret ariat should perform essentially technical-administrative and scientific tasks wi thout calling on the scie ntific and technical resources of the Member States. The Executiv e Director should ensure the efficient execution of the Agency's tasks in an indepe ndent manner. To ensure that the Agency fulfils its role, the composition of the Manage ment Board should be designed to represent each Member State, the Commission and ot her interested parties appointed by the Commission in order to ensure the involve ment of stakeholders, and the European Parliament and to secure the highest standard of competence and a broad range of relevant expertise in chemicals safety or the regulation of chemicals, whilst ensuring that there is relevant expertise in the field of general financial and legal matters. (99) The Agency should have the means to perfor m all the tasks required to carry out its role. (100) A Commission Regulation s hould specify the structure a nd amounts of fees, including specifying the circumstances under which a propor tion of the fees will be transferred to the relevant Member State competent authority. (101) The Management Board of the Agency shoul d have the necessary powers to establish the budget, check its implementation, draw up intern al rules, adopt fina ncial regulations and appoint the Executive Director. (102) Through a Committee for Risk Assessment and a Committee for Socio-economic Analysis, the Agency should take over the role of th e Scientific Committees attached to the Commission in issuing scientific opi nions in its field of competence.

32. L 396/32 EN Official Journal of the European Union 30.12.2006 (103) Through a Member State Committee, the Agency should aim to reach agreement amongst Member States authorities on specific issu es which require a harmonised approach. (104) It is necessary to ensure close coop eration between the Agency and the competent authorities working within the Member States so that the scientific opinions of the Committee for Risk Assessment and the Co mmittee for Socio-economic Analysis are based on the broadest possible scientific a nd technical expertise appropriate which is available within the Community. To the same end, these Committees should be able to rely on additional particular expertise. (105) In the light of the increased responsibility of natural or le gal persons for ensuring safe use of chemicals, enforcement needs to be stre ngthened. The Agency should therefore provide a Forum for Member States to exchange inform ation on and to coordina te their activities related to the enforcement of chemicals le gislation. The currently informal cooperation between Member States in this respect w ould benefit from a more formal framework. (106) A Board of Appeal should be set up within the Agency to guarantee processing of appeals for any natural or legal person affect ed by decisions taken by the Agency.

35. 30.12.2006 EN Official Journal of the European Union L 396/35 (114) To ensure a harmonised protection for the general public, and, in particular, for persons who come into contact with certain substa nces, and the proper functioning of other Community legislation relyi ng on the classification and la belling, an inventory should record the classification in accordan ce with Directive 67/548/EEC and Directive 1999/45/EC agreed by manufacturers and importers of the same substance, if possible, as well as decisions taken at Community level to ha rmonise the classification and labelling of some substances. This should ta ke full account of the work and experience accumulated in connection with the activitie s under Directive 67/548/EEC, including the classification and labelling of sp ecific substances or groups of substances listed in Annex I of Directive 67/548/EEC. (115) Resources should be focused on substances of the highest concer n. A substance should therefore be added to Annex I of Directiv e 67/548/EEC if it meets the criteria for classification as carcinogenic, mutagenic or t oxic for reproduction categories 1, 2 or 3, as a respiratory sensitiser, or in respect of other effects on a case-by-case basis. Provision should be made to enable competent authorities to submit proposals to the Agency. The Agency should give its opinion on the proposal while interest ed parties should have an opportunity to comment. The Commission should take a decision subsequently. (116) Regular reports by the Memb er States and the Agency on th e operation of this Regulation will be an indispensable mean s of monitoring the implementation of this Regulation as well as trends in this field. Conclusions draw n from findings in the reports will be useful and practical tools for reviewing this Regul ation and, where necessary, for formulating proposals for amendments.

37. 30.12.2006 EN Official Journal of the European Union L 396/37 (119) Apart from their partic ipation in the implementati on of Community legislation, Member State competent authorities should, beca use of their closeness to stakeholders in the Member States, play a role in the excha nge of information on ri sks of substances and on the obligations of natural or legal persons under chemicals legislation. At the same time, close cooperation between the Agency, the Co mmission and the competent authorities of the Member States is necessary to ensure the coherence and efficiency of the global communication process. (120) In order for the system established by this Regulation to operate effectively, there should be good cooperation, coordination and exch ange of information between the Member States, the Agency and the Commission regarding enforcement. (121) In order to ensure compliance with this Regulation, Member States should put in place effective monitoring and control measures. Th e necessary inspections should be planned, carried out and their resu lts should be reported. (122) In order to ensure transp arency, impartiality and consiste ncy in the level of enforcement activities by Member States, it is necessary for Member States to set up an appropriate framework for penalties with a view to imposing effective, proportionate and dissuasive penalties for non-compliance, as non-compliance can result in damage to human health and the environment.

41. 30.12.2006 EN Official Journal of the European Union L 396/41 TABLE OF CONTENTS TITLE I GENERAL ISSUES Chapter 1 Aim, scope and application Chapter 2 Definitions and general provision TITLE II REGISTRATION OF SUBSTANCES Chapter 1 General obligation to regi ster and information requirements Chapter 2 Substances regarded as being registered Chapter 3 Obligation to register and in formation requirements for certain types of isolated intermediates Chapter 4 Common provisions for all registrations Chapter 5 Transitional provisi ons applicable to phase-i n substances and notified substances

42. L 396/42 EN Official Journal of the European Union 30.12.2006 TITLE III DATA SHARING AND AVOI DANCE OF UNNECESSARY TESTING Chapter 1 Objectives and general rules Chapter 2 Rules for non-phase-in substa nces and registrants of phase-in substances who have not pre-registered Chapter 3 Rules for phase-in-substances TITLE IV INFORMATION IN THE SUPPLY CHAIN TITLE V DOWNSTREAM USERS TITLE VI EVALUATION Chapter 1 Dossier evaluation Chapter 2 Substance evaluation Chapter 3 Evaluation of intermediates Chapter 4 Common provisions

43. 30.12.2006 EN Official Journal of the European Union L 396/43 TITLE VII AUTHORISATION Chapter 1 Authorisation requirement Chapter 2 Granting of authorisations Chapter 3 Authorisations in the supply chain TITLE VIII RESTRICTIONS ON TH E MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES AND PREPARATIONS Chapter 1 General issues Chapter 2 Restrictions process TITLE IX FEES AND CHARGES TITLE X AGENCY TITLE XI CLASSIFICATION AND LABELLING INVENTORY TITLE XII INFORMATION TITLE XIII COMPETENT AUTHORITIES TITLE XIV ENFORCEMENT TITLE XV TRANSITIONAL AN D FINAL PROVISIONS

44. L 396/44 EN Official Journal of the European Union 30.12.2006 ANNEX I GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS ANNEX II GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS ANNEX III CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES ANNEX IV EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a) ANNEX V EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b) ANNEX VI INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10 ANNEX VII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTUR ED OR IMPORTED IN QUANTITIES OF 1 TONNE OR MORE

45. 30.12.2006 EN Official Journal of the European Union L 396/45 ANNEX VIII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTUR ED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE ANNEX IX STANDARD INFORM ATION REQUIREMENTS FOR SUBSTANCES MANUFACTUR ED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE ANNEX X STANDARD INFORMAT ION REQUIREMENTS FOR SUBSTANCES MANUFACTUR ED OR IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE ANNEX XI GENERAL RULES FOR AD APTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X ANNEX XII GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS

46. L 396/46 EN Official Journal of the European Union 30.12.2006 ANNEX XIII CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES ANNEX XIV LIST OF SUBSTANCES SUBJECT TO AUTHORISATION ANNEX XV DOSSIERS ANNEX XVI SOCIO-ECONOMIC ANALYSIS ANNEX XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES

51. 30.12.2006 EN Official Journal of the European Union L 396/51 6. The provisions of Title IV shall not apply to the following preparations in the finished state, intended for the final user: (a) medicinal products for human or veterinary use, within the scope of Regulation (EC) No 726/2004 and Directive 2001/82/EC and as defined in Directive 2001/83/EC; (b) cosmetic products as defi ned in Directive 76/768/EEC; (c) medical devices which are i nvasive or used in direct phys ical contact with the human body in so far as Community measures lay down provisions for the classification and labelling of dangerous substa nces and preparations which ensure the same level of information provision and prot ection as Directive 1999/45/EC; (d) food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use: (i) as a food additive in foodstuffs w ithin the scope of Directive 89/107/EEC; (ii) as a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC; (iii) as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003; (iv) in animal nutrition within the scope of Directive 82/471/EEC.

52. L 396/52 EN Official Journal of the European Union 30.12.2006 7. The following shall be exempted from Titles II, V and VI: (a) substances included in Annex IV, as sufficient information is known about these substances that they are considered to cau se minimum risk because of their intrinsic properties; (b) substances covered by Annex V, as re gistration is deemed inappropriate or unnecessary for these substances and their exemption from these Titles does not prejudice the objectives of this Regulation; (c) substances on their own or in preparati ons, registered in accordance with Title II, exported from the Community by an actor in the supply chain and re-imported into the Community by the same or another acto r in the same supply chain who shows that: (i) the substance being re-imported is the same as the exported substance; (ii) he has been provided with the inform ation in accordance with Articles 31 or 32 relating to the exported substance. (d) substances, on their own, in preparations or in articles, which have been registered in accordance with Title II and which ar e recovered in the Community if: (i) the substance that results from the recovery process is the same as the substance that has been registered in accordance with Title II; and

55. 30.12.2006 EN Official Journal of the European Union L 396/55 7) Registrant: means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance; 8) Manufacturing: means production or extracti on of substances in the natural state; 9) Manufacturer: means any natural or legal person established within the Community who manufactures a substance within the Community; 10) Import: means the physical introduction into the customs territory of the Community; 11) Importer: means any natura l or legal person established within the Community who is responsible for import; 12) Placing on the market: means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market; 13) Downstream user: means any natural or le gal person established within the Community, other than the manufacturer or the importer, who uses a substan ce, either on its own or in a preparation, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-im porter exempted pursuant to Article 2(7)(c) shall be regarded as a downstream user;

57. 30.12.2006 EN Official Journal of the European Union L 396/57 16) Site: means a single location, in which, if there is more than one manufacturer of (a) substance(s), certain infrastructure and facilities are shared; 17) Actors in the supply chain: means all ma nufacturers and/or importers and/or downstream users in a supply chain; 18) Agency: means the European Chemicals Agency as established by this Regulation; 19) Competent authority: means the authority or authorities or bodi es established by the Member States to carry out the obliga tions arising from this Regulation; 20) Phase-in substance: means a substance which meets at least one of the following criteria: (a) it is listed in the European Inve ntory of Existing Co mmercial Chemical Substances (EINECS); (b) it was manufactured in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, provided the ma nufacturer or importer has documentary evidence of this;

58. L 396/58 EN Official Journal of the European Union 30.12.2006 (c) it was placed on the market in the Commun ity, or in the countries acceding to the European Union on 1 January 1995 or on 1 Ma y 2004, before entry into force of this Regulation by the manufacturer or importer and was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC but does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this; 21) Notified substance: means a substance for which a notification has been submitted and which could be placed on the market in accordance with Directive 67/548/EEC; 22) Product and process orientated research and development: means any scientific development related to product development or the further development of a substance, on its own, in preparations or in articles in the course of whic h pilot plant or production trials are used to develop the producti on process and/or to test the fields of application of the substance; 23) Scientific research and development: means any scientific experime ntation, analysis or chemical research carried out under controlle d conditions in a volume less than 1 tonne per year; 24) Use: means any processing, formulation, cons umption, storage, keep ing, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation;

59. 30.12.2006 EN Official Journal of the European Union L 396/59 25) Registrant's own use: means an industr ial or professional use by the registrant; 26) Identified use: means a use of a substance on its own or in a preparation, or a use of a preparation, that is intended by an actor in the supply chain, including his own use, or that is made known to him in writing by an immediate downstream user; 27) Full study report: means a complete and co mprehensive description of the activity performed to generate the information. This covers the complete scientific paper as published in the literatu re describing the study performed or the full report prepared by the test house describing the study performed; 28) Robust study summary: means a detailed summ ary of the objectives, methods, results and conclusions of a full study report providing su fficient information to make an independent assessment of the study minimising the n eed to consult th e full study report; 29) Study summary: means a summary of the objec tives, methods, results and conclusions of a full study report providing sufficient informati on to make an assessment of the relevance of the study; 30) Per year: means per calendar year, unless stat ed otherwise, for phase-in substances that have been imported or manufactured for at least three consecutive years, quantities per year shall be calculated on the basis of the average production or import volumes for the three preceding calendar years;

64. L 396/64 EN Official Journal of the European Union 30.12.2006 2. Any producer or importer of articles sh all notify the Agency, in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 57 and is identified in accordance with Article 59(1), if both the following conditions are met: (a) the substance is present in those arti cles in quantities totalling over 1 tonne per producer or importer per year; (b) the substance is present in those articl es above a concentration of 0,1 % weight by weight (w/w). 3. Paragraph 2 shall not apply where the pr oducer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use including disposal. In such cases, the produ cer or importer shall supply appropriate instructions to the reci pient of the article. 4. The information to be notifie d shall include the following: (a) the identity and contact deta ils of the producer or importer as specified in section 1 of Annex VI, with the exception of their own use sites; (b) the registration number(s) referred to in Article 20(1), if available; (c) the identity of the substance as spec ified in sections 2.1 to 2.3.4 of Annex VI; (d) the classification of the substance(s) as specified in sections 4.1 and 4.2 of Annex VI;

65. 30.12.2006 EN Official Journal of the European Union L 396/65 (e) a brief description of the use(s) of the substance(s) in the article as specified in section 3.5 of Annex VI and of the uses of the article(s); (f) the tonnage range of the substance(s), su ch as 1-10 tonnes, 10-100 tonnes and so on. 5. The Agency may take decisions requiring pr oducers or importers of articles to submit a registration, in accordance with this Title, fo r any substance in thos e articles, if all the following conditions are met: (a) the substance is present in those arti cles in quantities totalling over 1 tonne per producer or importer per year; (b) the Agency has grounds for suspecting that: (i) the substance is released from the articles, and (ii) the release of the substance from the ar ticles presents a risk to human health or the environment; (c) the substance is not subject to paragraph 1. A submission for registration shall be accompan ied by the fee required in accordance with Title IX. 6. Paragraphs 1 to 5 shall not a pply to substances that have al ready been registered for that use.

71. 30.12.2006 EN Official Journal of the European Union L 396/71 (vii) robust study summaries of the inform ation derived from the application of Annexes VII to XI, if required under Annex I; (viii) an indication as to which of the inform ation submitted under (iii), (iv), (vi), (vii) or subparagraph (b) has been reviewed by an assessor chosen by the manufacturer or importer and having appr opriate experience; (ix) proposals for testing where li sted in Annexes IX and X; (x) for substances in quantities of 1 to 10 tonnes, exposure information as specified in section 6 of Annex VI; (xi) a request as to which of the informa tion in Article 119(2) the manufacturer or importer considers should not be made avai lable on the Internet in accordance with Article 77(2)(e), including a justification as to why publication could be harmful for his or any other concerned party's commercial interests. Except in cases covered under Article 25(3), Artic le 27(6) or Article 30(3), the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (vi) and (vii) fo r the purpose of registration; (b) a chemical safety report when required under Article 14, in the format specified in Annex I. The relevant sections of this re port may include, if the registrant considers appropriate, the relevant us e and exposure categories.

74. L 396/74 EN Official Journal of the European Union 30.12.2006 (a) the information specified in Annex VII for non-phase-in substances, and for phase-in substances meeting one or both of the crit eria specified in Annex III, manufactured or imported in quantities of 1 tonne or more per year per manufacturer or importer; (b) the information on physicochemical propertie s specified in Annex VII, section 7 for phase-in substances manufactured or impor ted in quantities of 1 tonne or more per year per manufacturer or importer which do not meet either of the criteria specified in Annex III; (c) the information specified in Annexes V II and VIII for substances manufactured or imported in quantities of 10 tonnes or more per year per manufacturer or importer; (d) the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annex IX for substances manufactured or imported in quantities of 100 tonnes or more per year per manufacturer or importer; (e) the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annexes IX and X for substances manufactured or imported in quantities of 1 000 tonnes or more per year per manufacturer or importer. 2. As soon as the quantity of a substance per ma nufacturer or importer th at has already been registered reaches the next t onnage threshold, the manufactur er or importer shall inform the Agency immediately of the additional info rmation he would requ ire under paragraph 1. Article 26(3) and (4) shall apply adapted as necessary.

76. L 396/76 EN Official Journal of the European Union 30.12.2006 3. Where tests on substances are required to ge nerate information on in trinsic properties of substances, they shall be conducted in accordan ce with the test methods laid down in a Commission Regulation or in ac cordance with other internati onal test methods recognised by the Commission or the Agency as being a ppropriate. The Commissi on shall adopt that Regulation, designed to amend the non-esse ntial elements of this Regulation by supplementing it, in accordance with the pr ocedure referred to in Article 133(4). Information on intrinsic properties of substanc es may be generated in accordance with other test methods provided that the c onditions set out in Annex XI are met. 4. Ecotoxicological and toxicologi cal tests and analyses shall be carried out in compliance with the principles of good laboratory pract ice provided for in Directive 2004/10/EC or other international standards recognised as being equivale nt by the Commission or the Agency and with the provisions of Directive 86/609/EEC , if applicable. 5. If a substance has already been registered, a ne w registrant shall be en titled to refer to the study summaries or robust study summaries, for the same substance submitted earlier, provided that he can show that the substance that he is now re gistering is the same as the one previously registered, including the degr ee of purity and the nature of impurities, and that the previous registrant(s) have given pe rmission to refer to the full study reports for the purpose of registration. A new registrant shall not refer to such studies in order to provide the information required in section 2 of Annex VI.

78. L 396/78 EN Official Journal of the European Union 30.12.2006 (d) the concentration limits given in Part B of Annex III to Directive 1999/45/EC; (e) the concentration limits given in an agr eed entry in the classification and labelling inventory established under Ti tle XI of this Regulation; (f) 0,1 % weight by weight (w/w), if the s ubstance meets the crite ria in Annex XIII of this Regulation. 3. A chemical safety assessment of a subs tance shall include the following steps: (a) human health hazard assessment; (b) physicochemical hazard assessment; (c) environmental hazard assessment; (d) persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment. 4. If, as a result of carrying out steps (a) to (d) of paragraph 3, the registrant concludes that the substance meets the criteria for classi fication as dangerous in accordance with Directive 67/548/EEC or is assessed to be a PBT or vPvB, the chemical safety assessment shall include the following additional steps: (a) exposure assessment including the generation of exposure scenario(s) (or the identification of relevant use and exposure categories if appr opriate) and exposure estimation;

84. L 396/84 EN Official Journal of the European Union 30.12.2006 2. A registration for a transported isolated intermediate shall include all the following information: (a) the identity of the manuf acturer or importer as specified in section 1 of Annex VI; (b) the identity of the intermediate as sp ecified in sections 2.1 to 2.3.4 of Annex VI; (c) the classification of the intermediate as specified in section 4 of Annex VI; (d) any available existing information on physicochemical, human health or environmental properties of the intermediate . Where a full study report is available, a study summary shall be submitted; (e) a brief general descriptio n of the use, as specified in section 3.5 of Annex VI; (f) information on risk management measures applied and recommended to the user in accordance with paragraph 4. Except in cases covered under Article 25(3), Artic le 27(6) or Article 30(3), the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (d) for the purpose of registration. The registration shall be accompanied by the f ee required in accordan ce with Title IX. 3. A registration for a transported isolated intermediate in quantities of more than 1 000 tonnes per year per manufacturer or impor ter shall include the information specified in Annex VII in addition to the information required under paragraph 2. For the generation of this info rmation, Article 13 shall apply.

85. 30.12.2006 EN Official Journal of the European Union L 396/85 4. Paragraphs 2 and 3 shall a pply only to transported isolated intermediates if the manufacturer or importer confirms himself or states that he has received confirmation from the user that the synthesis of (an)other subs tance(s) from that intermediate takes place on other sites under the following strictly controlled conditions: (a) the substance is rigorously contained by technical means duri ng its whole lifecycle including manufacture, purif ication, cleaning and maintenance of equipment, sampling, analysis, loading and unloading of equipment or vessels, waste disposal or purification and storage; (b) procedural and control technologies sha ll be used that minimise emission and any resulting exposure; (c) only properly trained and authoris ed personnel handle the substance; (d) in the case of cleaning and maintenance works, special procedures such as purging and washing are applied before the system is opened and entered; (e) in cases of accident and where waste is generated, procedural and/or control technologies are used to minimise emi ssions and the resulting exposure during purification or cleaning a nd maintenance procedures; (f) substance-handling procedures are well documented and strictly supervised by the site operator. If the conditions listed in the first subparagraph are not fulfilled, the registration shall include the information specified in Article 10.

88. L 396/88 EN Official Journal of the European Union 30.12.2006 The Agency shall undertake the completeness check within three weeks of the submission date, or within three months of the relevant deadline of Article 23, as regards registrations of phase-in substances submitted in the c ourse of the two-month period immediately preceding that deadline. If a registration is incomplete, the Agency shal l inform the registrant, before expiry of the three-week or three-month period referred to in the second subparagraph, as to what further information is required in order for the re gistration to be complete, while setting a reasonable deadline for this. The registrant shall complete his registration and submit it to the Agency within the deadline set. The Agen cy shall confirm the submission date of the further information to the registrant. The Agency shall perform a further completeness check, considering the furthe r information submitted. The Agency shall reject the regi stration if the registrant fail s to complete his registration within the deadline set. The registration f ee shall not be reimbursed in such cases. 3. Once the registration is complete, the Agency shall assign a registration number to the substance concerned and a registration date, which shall be the same as the submission date. The Agency shall without delay communicate the registration number and registration date to the regist rant concerned. The registration number shall be used for all subsequent correspondence regarding registration.

89. 30.12.2006 EN Official Journal of the European Union L 396/89 4. The Agency shall notify the competent author ity of the relevant Member State within 30 days of the submission date, that the followi ng information is available in the Agency database: (a) the registration dossier together with the submission or registration number; (b) the submission or registration date; (c) the result of the completeness check; and (d) any request for further information and deadline set in accordance with the third subparagraph of paragraph 2. The relevant Member State shall be the Memb er State within which the manufacture takes place or the importer is established. If the manufacturer has production sites in mo re than one Member State, the relevant Member State shall be the one in which the h ead office of the manufact urer is established. The other Member States where the production s ites are established sha ll also be notified. The Agency shall forthwith notify the competent authority of the relevant Member State(s) when any further information submitted by th e registrant is available on the Agency database.

93. 30.12.2006 EN Official Journal of the European Union L 396/93 2. A registrant shall submit to the Agency an update of the registration containing the information required by the decision made in accordance with Articles 40, 41 or 46 or take into account a decision made in accordance w ith Articles 60 and 73, within the deadline specified in that decision. The Agency shall notify the competent aut hority of the relevant Member State that the informati on is available on its database. 3. The Agency shall undertake a completeness check according to Article 20(2) first and second subparagraphs of each updated registration. In cases where the update is in accordance with Article 12(2) and with paragraph 1(c) of this Article then the Agency shall check the completeness of the information s upplied by the registrant and Article 20(2) shall apply adapted as necessary. 4. In cases covered by Articles 11 or 19, each registrant shall submit separately the information specified in para graph 1(c) of this Article. 5. An update shall be accompanied by the relevant part of the fee required in accordance with Title IX.

99. 30.12.2006 EN Official Journal of the European Union L 396/99 2. When a request for information has been ma de according to paragraph 1, the potential and the previous registrant(s) as referred to in pa ragraph 1 shall make every effort to reach an agreement on the sharing of the information re quested by the potential registrant(s) with respect to Article 10(a)(vi) and (vii). Such an agreement may be replaced by submission of the matter to an arbitration board a nd acceptance of the arbitration order. 3. The previous registrant and poten tial registrant(s) shall make every effort to ensure that the costs of sharing the information are de termined in a fair, transparent and non-discriminatory way. This may be facilita ted by following cost sharing guidance based on those principles which is adopted by the Agency in accordance with Article 77(2)(g). Registrants are only required to share in the co sts of information that they are required to submit to satisfy their registration requirements. 4. On agreement on the sharing of the inform ation, the previous registrant shall make available to the new registrant the agreed info rmation and shall give the new registrant the permission to refer to the previ ous registrant's full study report. 5. If there is failure to reach such an agreemen t, the potential registrant(s) shall inform the Agency and the previous registrant(s) thereof at the earliest one month after receipt, from the Agency, of the name and addre ss of the previous registrant(s).

100. L 396/100 EN Official Journal of the European Union 30.12.2006 6. Within one month from the receipt of the information referred to in paragraph 5, the Agency shall give the potentia l registrant permission to refe r to the information requested by him in his registration dossi er, subject to the potential registrant providing, upon request by the Agency, proof that he has paid the previo us registrant(s) for that information a share of cost incurred. The previous registrant(s) sh all have a claim on the potential registrant for a proportionate share of the cost incurred by him. Calculation of the proportionate share may be facilitated by the guidance adopted by the Agency in accordance with Article 77(2)(g). Provided he makes the fu ll study report available to the potential registrant, the previous regist rant(s) shall have a claim on th e potential registrant for an equal share of the cost incurred by him, which shall be enforceable in the national courts. 7. An appeal may be brought, in accordance with Articles 91, 92 and 93, against Agency decisions under paragraph 6 of this Article. 8. The registration waiting period in accordance with Article 21(1) for the new registrant shall be extended by a period of four months, if the previous registrant so requests.

106. L 396/106 EN Official Journal of the European Union 30.12.2006 2. If a relevant study involving tests is not av ailable within the SIEF, only one study shall be conducted per information requirement within e ach SIEF by one of its participants acting on behalf of the others. They shall take all r easonable steps to reach an agreement within a deadline set by the Agency as to who is to carry out the test on behalf of the other participants and to submit a summary or robust study summary to the Agency. If no agreement is reached, the Agency shall specif y which registrant or downstream user shall perform the test. All participants of the SIEF who require a study shal l contribute to the costs for the elaboration of the study with a share corresponding to the number of participating potential regist rants. Those participants th at do not carry out the study themselves shall have the right to receive the full study report within two weeks following payment to the participant that carried out the study. 3. If the owner of a study as referred to in pa ragraph 1 which involves testing on vertebrate animals refuses to provide eith er proof of the cost of that study or the study itself to (an)other participant(s), he shall not be able to proceed with regi stration until he provides the information to the other participants(s). The other participant(s) shall proceed with registration without fulfilling the relevant information requi rement, explaining the reason for this in the registration dossier. The study sh all not be repeated unless within 12 months of the date of registration of the other partic ipant(s), the owner of this information has not provided it to them and the Agency decides that the test should be repeated by them. However, if a registration containing this information has already been submitted by another registrant, the Agency shall give the ot her participant(s) permission to refer to the information in his registration dossier(s). Th e other registrant shall have a claim on the other participant(s) for an equal share of th e cost, provided he makes the full study report available to the other particip ant(s), which shall be enfor ceable in the na tional courts.

109. 30.12.2006 EN Official Journal of the European Union L 396/109 4. The safety data sheet need not be supplied where dangerous substances or preparations offered or sold to the general public are pr ovided with sufficient information to enable users to take the necessary m easures as regards the protecti on of human health, safety and the environment, unless requested by a downstream user or distributor. 5. The safety data sheet shall be supplied in an official language of the Member State(s) where the substance or preparation is placed on the market, unless the Member State(s) concerned provide otherwise. 6. The safety data sheet shall be dated and shall contain the following headings: 1. identification of the substance/prepar ation and of the company/undertaking; 2. hazards identification; 3. composition/information on ingredients; 4. first-aid measures; 5. fire-fighting measures; 6. accidental release measures; 7. handling and storage; 8. exposure controls/p ersonal protection; 9. physical and chemical properties; 10. stability and reactivity; 11. toxicological information;

110. L 396/110 EN Official Journal of the European Union 30.12.2006 12. ecological information; 13. disposal considerations; 14. transport information; 15. regulatory information; 16. other information. 7. Any actor in the supply chain who is required to prepare a chemical safety report according to Articles 14 or 37 shall place the relevant exposure scenarios (including use and exposure categories where appropriate) in an annex to the safety data sh eet covering identified uses and including specific conditions resulting from the applicati on of section 3 of Annex XI. Any downstream user shall include relevant e xposure scenarios, a nd use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for identified uses. Any distributor shall pass on relevant e xposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for uses for which he has passed on information accordi ng to Article 37(2). 8. A safety data sheet shall be provided fr ee of charge on paper or electronically.

112. L 396/112 EN Official Journal of the European Union 30.12.2006 (d) any other available and rele vant information about the subs tance that is necessary to enable appropriate risk management measures to be identified and applied including specific conditions resulting from the a pplication of secti on 3 of Annex XI. 2. The information referred to in paragraph 1 shall be communicated free of charge on paper or electronically at the latest at the time of the first delivery of a substance on its own or in a preparation after 1 June 2007. 3. Suppliers shall update this information without delay on the following occasions: (a) as soon as new information which may aff ect the risk management measures, or new information on hazards becomes available; (b) once an authorisation has been granted or refused; (c) once a restriction has been imposed. In addition, the updated information shall be provided free of charge on paper or electronically to all former recipients to whom they ha ve supplied the substance or preparation within the pr eceding 12 months. Any updates following registration shall include the registration number.

116. L 396/116 EN Official Journal of the European Union 30.12.2006 3. For registered substances, the manufacturer, importer or downstream user shall comply with the obligations laid down in Article 14 either before he next supplies the substance on its own or in a preparation to the downstream user making the request referred to in paragraph 2 of this Article, provided that the request was ma de at least one month before the supply, or within one month after the request, whichever is the later. For phase-in substances, the manufacturer, impor ter or downstream user shall comply with this request and with the obligations laid down in Article 14 before the relevant deadline in Article 23 has expired, provide d that the downstream user makes his request at least 12 months before the deadline in question. Where the manufacturer, importer or downs tream user, having assessed the use in accordance with Article 14, is unable to include it as an identified use for reasons of protection of human health or the environment, he shall provide the Agency and the downstream user with the reason (s) for that decision in writing without delay and shall not supply downstream user(s) with the substance without including these reason(s) in the information referred to under Articles 31 or 32. The manufacturer or im porter shall include this use in section 3.7 of Annex VI in his update of the registration in accordance with Article 22(1)(d). 4. A downstream user of a substance on its own or in a preparation shall prepare a chemical safety report in accordance with Annex XII for any use outside the conditions described in an exposure scenario or if appropriate a us e and exposure category communicated to him in a safety data sheet or for a ny use his supplier advises against.

117. 30.12.2006 EN Official Journal of the European Union L 396/117 A downstream user need not prepare such a ch emical safety report in any of the following cases: (a) a safety data sheet is not required to be communicat ed with the substance or preparation in accordance with Article 31; (b) a chemical safety report is not required to be completed by his supplier in accordance with Article 14; (c) the downstream user uses the substance or preparation in a total quantity of less than 1 tonne per year; (d) the downstream user implements or recommends an exposure scenario which includes as a minimum the conditions described in the exposure scenario communicated to him in the safety data sheet; (e) the substance is present in a preparati on in a concentration lo wer than any of the concentrations set out in Article 14(2); (f) the downstream user is using the substa nce for the purposes of product and process oriented research and development, provide d that the risks to human health and the environment are adequately controlled in accordance with the requirements of legislation for the protection of workers and the environment.

118. L 396/118 EN Official Journal of the European Union 30.12.2006 5. Any downstream user shall identify, apply and where suitable, recommend, appropriate measures to adequately control risks identified in any of the following: (a) the safety data sheet(s) supplied to him; (b) his own chemical safety assessment; (c) any information on risk management meas ures supplied to him in accordance with Article 32. 6. Where a downstream user does not prepare a ch emical safety report in accordance with paragraph 4(c), he shall consid er the use(s) of the substan ce and identify and apply any appropriate risk management measures needed to ensure that the risks to human health and the environment are adequately controlled. Where necessary, this information shall be included in any safety data sheet prepared by him. 7. Downstream users shall keep their chemical safety report up to date and available. 8. A chemical safety report prepared in accord ance with paragraph 4 of this Article need not include consideration of the risks to human health from the end uses set out in Article 14(5).

124. L 396/124 EN Official Journal of the European Union 30.12.2006 (c) that any required chemical safety assessm ent and chemical safety report comply with the requirements of Annex I and that th e proposed risk management measures are adequate; (d) that any explanation(s) submitted in acco rdance with Article 11( 3) or Article 19(2) have an objective basis. 2. The list of dossiers being checked for complian ce by the Agency shall be made available to Member States competent authorities. 3. On the basis of an examination made pursu ant to paragraph 1, th e Agency may, within 12 months of the start of the compliance check, prepare a draft decision requiring the registrant(s) to submit any information needed to bring the registration(s) into compliance with the relevant informati on requirements and specifying adequate time limits for the submission of further information. Such a deci sion shall be taken in accordance with the procedure laid down in Articles 50 and 51. 4. The registrant shall submit the information required to the Agency by the deadline set. 5. To ensure that registration dossiers comply with this Regulation, the Agency shall select a percentage of those dossiers, no lower than 5 % of the total recei ved by the Agency for each tonnage band, for compliance checking. The Agency shall give priority, but not exclusively, to dossiers meeting at l east one of the following criteria:

129. 30.12.2006 EN Official Journal of the European Union L 396/129 2. A Member State may choose (a) substance( s) from the draft Community rolling action plan, with the aim of becoming a competent authority for the purpos es of Articles 46, 47 and 48. In the event of a substance from the dr aft Community rolling action plan not being chosen by any Member State, the Agency shal l ensure that the substance is evaluated. 3. In cases where two or more Member States have expressed an inte rest in evaluating the same substance and they cannot agree w ho should be the competent authority, the competent authority for the purposes of Artic les 46, 47 and 48 shall be determined in accordance with the following procedure. The Agency shall refer the matter to the Memb er State Committee, in order to agree which authority shall be the competent authority, taki ng into account the Member State in which the manufacturer(s) or importer(s) is lo cated, the respective proportions of total Community gross domestic product, the number of substances alrea dy being evaluated by a Member State and the expertise available. If, within 60 days of the referral, th e Member State Committee reaches unanimous agreement, the Member States concerned shall adopt substances for evaluation accordingly. If the Member State Committee fails to reac h a unanimous agreement, the Agency shall submit the conflicting opinions to the Comm ission, which shall decide which authority shall be the competent authority, in accord ance with the procedure referred to in Article 133(3), and the Member States concer ned shall adopt substances for evaluation accordingly.

142. L 396/142 EN Official Journal of the European Union 30.12.2006 (c) substances meeting the criter ia for classification as toxic for reproduction category 1 or 2 in accordance with Directive 67/548/EEC; (d) substances which are persistent, bioaccumula tive and toxic in accordance with the criteria set out in Annex XIII of this Regulation; (e) substances which are very persistent a nd very bioaccumulative in accordance with the criteria set out in Annex XIII of this Regulation; (f) substances - such as those having endo crine disrupting proper ties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) - for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivale nt level of concern to those of other substances listed in points (a) to (e) and which ar e identified on a case-by-case basis in accordance with the procedure set out in Article 59.

144. L 396/144 EN Official Journal of the European Union 30.12.2006 (d) review periods for certa in uses, if appropriate; (e) uses or categories of uses exempted fro m the authorisation requirement, if any, and conditions for such exemptions, if any. 2. Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the prot ection of human health or th e environment for the use of the substance, the risk is properly controlle d. In the establishment of such exemptions, account shall be taken, in particular, of the pr oportionality of risk to human health and the environment related to the nature of the substa nce, such as where the risk is modified by the physical form. 3. Prior to a decision to include substances in Annex XIV, the Agency shall, taking into account the opinion of the Member State Committ ee, recommend priority substances to be included specifying for each substance the it ems set out in paragraph 1. Priority shall normally be given to substances with: (a) PBT or vPvB properties; or (b) wide dispersive use; or (c) high volumes.

145. 30.12.2006 EN Official Journal of the European Union L 396/145 The number of substances included in Annex XIV and the dates specified under paragraph 1 shall also take acc ount of the Agency's capacity to handle applications in the time provided for. The Agency shall make its first recommendation of priority substances to be included in Annex XIV by 1 June 2009. The Agency shall make further recommendations at least every second year with a view to including further substances in Annex XIV. 4. Before the Agency sends its recommendation to the Commission it shall make it publicly available on its website, clea rly indicating the date of publication, taking into account Articles 118 and 119 on access to information. Th e Agency shall invite all interested parties to submit comments within three months of the date of publication, in particular on uses which should be exempt from the authorisation requirement. The Agency shall update its recommendation, ta king into account the comments received. 5. Subject to paragraph 6, after inclusion of a substance in Annex XIV, this substance shall not be subjected to new restrictions under the procedure outlined in Title VIII covering the risks to human health or the environment from the use of the substance on its own, in a preparation or incorporation of a substance in an article arising from the intrinsic properties specified in Annex XIV. 6. A substance listed in Annex XIV may be subjec ted to new restrictions under the procedure outlined in Title VIII covering the risks to human health or the environment from the presence of the substance in (an) article(s).

150. L 396/150 EN Official Journal of the European Union 30.12.2006 (c) substances identified under Article 57 (f) having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties. 4. If an authorisation cannot be granted under paragraph 2 or for substances listed in paragraph 3, an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no su itable alternative substances or technologies. This decision shall be taken after considerat ion of all of the following el ements and taking into account the opinions of the Committee for Risk Assessment and the Committee for Socio-economic Analysis referred to in Article 64(4)(a) and (b): (a) the risk posed by the uses of the s ubstance, including th e appropriateness and effectiveness of the risk ma nagement measures proposed; (b) the socio-economic benefits arising from its use and the socio-economic implications of a refusal to authorise as demonstrated by the applicant or other interested parties; (c) the analysis of the alternatives submitted by the applicant under Article 62(4)(e) or any substitution plan submitted by the appl icant under Article 62(4)(f), and any third party contributions submitted under Article 64(2); (d) available information on the risks to human health or the environment of any alternative substances or technologies.

151. 30.12.2006 EN Official Journal of the European Union L 396/151 5. When assessing whether suitabl e alternative substances or te chnologies are available, all relevant aspects shall be taken into account by the Commission, including: (a) whether the transfer to alternatives w ould result in reduced overall risks to human health and the environment, taking into acc ount the appropriateness and effectiveness of risk management measures; (b) the technical and economic feasibility of alterna tives for the applicant. 6. A use shall not be authorised if this would c onstitute a relaxation of a restriction set out in Annex XVII. 7. An authorisation shall be granted only if th e application is made in conformity with the requirements of Article 62. 8. Authorisations shall be subject to a time-li mited review without prejudice to any decision on a future review period and shall norm ally be subject to conditions, including monitoring. The duration of the time-limited review for any authorisation shall be determined on a case-by-case basis taking into account all relevant information including the elements listed in paragraph 4(a) to (d), as appropriate. 9. The authorisation shall specify: (a) the person(s) to whom th e authorisation is granted; (b) the identity of the substance(s);

153. 30.12.2006 EN Official Journal of the European Union L 396/153 A holder of an authorisation granted in accordance with Ar ticle 60 shall submit an update of the analysis of alternativ es referred to in Article 62(4 )(e), including information about any relevant research and development activit ies by the applicant, if appropriate, and any substitution plan submitted under Article 62(4 )(f). If the update of the analysis of alternatives shows that there is a suitable alternative available taking into account the elements in Article 60(5), he shall submit a substitution plan, including a timetable for proposed actions by the applican t. If the holder cannot demo nstrate that the risk is adequately controlled, he sh all also submit an update of the socio-economic analysis contained in the orig inal application. If he can now demonstrate that the risk is ad equately controlled, he shall submit an update of the chemical safety report. If any other elements of the original application have cha nged, he shall also submit updates of these element(s). When any updated information is submitted in accordance with this paragraph, any decision to amend or withdraw the authorisation in the context of the review shall be taken in accordance with the procedure referred to in Article 64 applied mutatis mutandis.

154. L 396/154 EN Official Journal of the European Union 30.12.2006 2. Authorisations may be reviewed at any time if: (a) the circumstances of the original authorisa tion have changed so as to affect the risk to human health or the environment, or the socio-economic impact; or (b) new information on possible substitutes becomes available. The Commission shall set a reasonable deadline by which the holder(s) of the authorisation may submit further information necessary for th e review and indicate by when it will take a decision in accordance with Article 64. 3. In its review decision the Co mmission may, if circumstances have changed and taking into account the principle of proporti onality, amend or withdraw th e authorisation, if under the changed circumstances it would not have been granted or if suitable alternatives in accordance with Article 60(5) b ecome available. In the latter case the Commission shall require the holder of the author isation to present a substitution plan if he has not already done so as part of his application or update. In cases where there is a seri ous and immediate risk for human health or the environment, the Commission may suspend the authorisation pending the review, taking into account the principle of proportionality.

156. L 396/156 EN Official Journal of the European Union 30.12.2006 4. An application for authorisation sh all include the following information: (a) the identity of the substance(s), as referred to in sec tion 2 of Annex VI; (b) the name and contact details of the pe rson or persons making the application; (c) a request for authorisation, specifying fo r which use(s) the authorisation is sought and covering the use of the substance in pr eparations and/or the incorporation of the substance in articles, wh ere this is relevant; (d) unless already submitted as part of the registration, a chemical safety report in accordance with Annex I covering the risks to human health and/or the environment from the use of the substance(s) arising fr om the intrinsic properties specified in Annex XIV; (e) an analysis of the alternatives consider ing their risks and the technical and economic feasibility of substitution a nd including, if appropriate in formation about any relevant research and development activities by the applicant; (f) where the analysis referred to in point (e) shows that suitable alternatives are available, taking into account the elements in Article 60(5), a substitution plan including a timetable for propos ed actions by the applicant.

157. 30.12.2006 EN Official Journal of the European Union L 396/157 5. The application may include: (a) a socio-economic analysis conducted in accordance with Annex XVI; (b) a justification for not considering risks to human health and the environment arising either from: (i) emissions of a substance from an inst allation for which a permit was granted in accordance with Directive 96/61/EC; or (ii) discharges of a substance from a poi nt source governed by the requirement for prior regulation referred to in Articl e 11(3)(g) of Direct ive 2000/60/EC and legislation adopted under Artic le 16 of that Directive. 6. The application shall not incl ude the risks to human health arising from the use of a substance in a medical device regulated by Directives 90/385/EEC, 93/42/EEC or 98/79/EC. 7. An application for an authorisation shall be accompanied by the fee required in accordance with Title IX.

159. 30.12.2006 EN Official Journal of the European Union L 396/159 2. The Agency shall make available on its web- site broad informati on on uses, taking into account Articles 118 and 119 on access to informa tion, for which applications have been received and for reviews of authorisati ons, with a deadline by which information on alternative substances or technologies may be submitted by interested third parties. 3. In preparing its opinion, each Committee referred to in paragraph 1 sh all first check that the application includes all the information speci fied in Article 62 that is relevant to its remit. If necessary, the Committees shall, in consultation with each other, make a joint request to the applicant for a dditional information to bring th e application into conformity with the requirements of Article 62. The Co mmittee for Socio-economic Analysis may, if it deems it necessary, require the applicant or request third parties to submit, within a specified time period, additional informati on on possible alternative substances or technologies. Each Committee shall also ta ke into account any information submitted by third parties. 4. The draft opinions shall in clude the following elements: (a) Committee for Risk Assessment: an assessmen t of the risk to human health and/or the environment arising from the use( s) of the substa nce, including the appropriateness and effectiveness of the risk management measures as described in the application and, if relevant, an asse ssment of the risks arising from possible alternatives;

160. L 396/160 EN Official Journal of the European Union 30.12.2006 (b) Committee for Socio-economic Analysis : an assessment of the socio-economic factors and the availability, suitability and technical feasibility of alternatives associated with the use(s) of the substance as described in the application, when an application is made in accordance with Article 62 and of any third party contributions submitted under paragraph 2 of this Article. 5. The Agency shall send these draft opinions to the applicant by the end of the deadline set out in paragraph 1. Within one month of recei pt of the draft opinion, the applicant may provide written notice that he wishes to comm ent. The draft opinion shall be deemed to have been received seven days after the Agency has sent it. If the applicant does not wish to comment, the Agency shall send these opinions to the Commission, the Member States and the applican t, within 15 days of the end of the period within which the applicant may comment or w ithin 15 days of receipt of notice from the applicant that he does not intend to comment. If the applicant wishes to comment, he shall send his written argumentation to the Agency within two months of the r eceipt of the draft opinion. The Committees shall consider the comments and adopt their final opinions with in two months of receipt of the written argumentation, taking this argumentation into ac count where appropriate. Within a further 15 days the Agency shall send the opinions, wi th the written argumentation attached, to the Commission, the Member Stat es and the applicant.

161. 30.12.2006 EN Official Journal of the European Union L 396/161 6. The Agency shall determine in accordance wi th Articles 118 and 119 which parts of its opinions and parts of any attachments theret o should be made publicly available on its website. 7. In cases covered by Article 63(1), the Agen cy shall treat the applications together, provided the deadlines for the fi rst application can be met. 8. The Commission shall prepare a draft authorisat ion decision within thre e months of receipt of the opinions from the Agency. A final deci sion granting or refu sing the authorisation shall be taken in accordance with the pr ocedure referred to in Article 133(2). 9. Summaries of the Commission decisions, in cluding the authorisa tion number and the reasons for the decision, in par ticular where suitable alternatives exist, shall be published in the Official Journal of the European Uni on and shall be made publicly available in a database established and kept up to date by the Agency. 10. In cases covered by Article 63(2), the deadline set out in paragraph 1 of this Article shall be shortened to five months.

166. L 396/166 EN Official Journal of the European Union 30.12.2006 4. If a Member State considers that the manu facture, placing on the market or use of a substance on its own, in a preparation or in an article poses a risk to human health or the environment that is not adequately controlled and needs to be addr essed it shall notify the Agency that it proposes to prepare a dossier which conforms to the requirements of the relevant sections of Annex XV. If the substa nce is not on the list maintained by the Agency referred to in paragraph 5 of this Article, the Member State shall prepare a dossier which conforms to the requirements of Annex XV w ithin 12 months of the notification to the Agency. If this dossier demonstrates that action on a Community-wide basis is necessary, beyond any measures already in place, the Memb er State shall submit it to the Agency in the format outlined in Annex XV, in orde r to initiate the restrictions process. The Agency or Member States shall refer to any dossier, chemical sa fety report or risk assessment submitted to the Agency or Member State under this Regulation. The Agency or Member States shall also refer to any relevant risk assessment submitted for the purposes of other Community Regulations or Di rectives. To this end other bodies, such as agencies, established under Community law a nd carrying out a similar task shall provide information to the Agency or Member State concerned on request.

167. 30.12.2006 EN Official Journal of the European Union L 396/167 The Committee for Risk Assessment and th e Committee for Socio-economic Analysis shall check whether the dossier submitted c onforms to the requirements of Annex XV. Within 30 days of receipt, the respective Committee shall inform the Agency or the Member State suggesting restrictions, as to whether the dossier conf orms. If the dossier does not conform, the reasons shall be given to the Agency or the Member State in writing within 45 days of receipt. The Agency or the Member State shall bring the dossier into conformity within 60 days of the date of receipt of the reasons from the Committees, otherwise the procedure under th is Chapter shall be terminat ed. The Agency shall publish without delay the intention of the Commissi on or of a Member State to instigate a restriction procedure for a substance and shall inform those who submitted a registration for that substance. 5. The Agency shall maintain a list of subs tances for which a dossier conforming to the requirements of Annex XV is planned or underway by either the Agency or a Member State for the purposes of a proposed re striction. If a substan ce is on the list, no other such dossier shall be prepared. If it is proposed by either a Member State or the Agency that an existing restriction listed in Annex XVII should be re-examined a decision on whether to do so shall be taken in accord ance with the procedure referred to in Article 133(2) based on evidence presente d by the Member State or the Agency.

172. L 396/172 EN Official Journal of the European Union 30.12.2006 3. The structure and amount of the fees referred to in paragraph 1 shall take account of the work required by this Regulation to be carried out by the Agency and the competent authority and shall be fixed at such a level as to ensure that the revenue derived from them when combined with other sources of the Agen cy's revenue pursuant to Article 96(1) is sufficient to cover the cost of the services de livered. The fees set for registration shall take into account the work that ma y be done pursuant to Title VI. In the case of Article 6(4), Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2) and Article 18(2), the structure and amount of fees shall take account of the tonnage range of the substance being registered. In all cases, a reduced fe e shall be set for SMEs. In the case of Article 11(4), the structure and amount of fees shall take into account whether information has been submitted jointly or separately. In the case of a request made under Article 10( a)(xi), the structure and amount of fees shall take into account the work required by th e Agency in assessing the justification. 4. The Regulation referred to in paragraph 1 shall specify the circumstances under which a proportion of the fees will be tr ansferred to the relevant Memb er State competent authority. 5. The Agency may collect charges for other services it provides.

174. L 396/174 EN Official Journal of the European Union 30.12.2006 (d) a Committee for Socio-economic Analysis, which shall be responsible for preparing the opinion of the Agency on applica tions for authoris ation, proposals for restrictions, and any other questions that arise from the operation of this Regulation relating to the socio-economic impact of possible legislative action on substances; (e) a Member State Committee, which shall be responsible for resolving potential divergences of opinions on draft deci sions proposed by the Agency or the Member States under Title VI and proposals fo r identification of substances of very high concern to be subjected to the au thorisation procedur e under Title VII; (f) a Forum for Exchange of Information on Enforcement (hereinafter referred to as "the Forum") which shall coordinate a network of Member States authorities responsible for enforcement of this Regulation; (g) a Secretariat, which shall work under the leadership of the Executive Director and provide technical, scientific and administ rative support for the Committees and the Forum and ensure appropriate coordination be tween them. It shall also undertake the work required of the Agency under the pro cedures for pre-registration, registration and evaluation as well as preparation of guidance, database maintenance and information provision; (h) a Board of Appeal, which shall decide on appeals against decisions taken by the Agency.

177. 30.12.2006 EN Official Journal of the European Union L 396/177 (i) providing guidance to stakeholders incl uding Member State competent authorities on communication to the public of information on the risks and safe use of substances, on their own, in preparations or in articles; (j) providing advice and assistance to ma nufacturers and importers registering a substance in accordance with Article 12(1); (k) preparing explanatory information on this Regulation for other stakeholders; (l) at the Commission's request, providing t echnical and scientific support for steps to improve cooperation between the Communit y, its Member States, international organisations and third countries on scientif ic and technical issues relating to the safety of substances, as well as active pa rticipation in technical assistance and capacity building activities on sound mana gement of chemicals in developing countries; (m) keeping a Manual of Decisions and Op inions based on conclusions from the Member State Committee regarding interpretation and implementation of this Regulation; (n) notification of decisi ons taken by the Agency; (o) provision of formats for submission of information to the Agency.

178. L 396/178 EN Official Journal of the European Union 30.12.2006 3. The Committees shall undertake the following tasks: (a) performing the tasks allotted to them under Titles VI to XI; (b) at the Executive Director's request, pr oviding technical and sc ientific support for steps to improve cooperation between the Community, its Member States, international organisations and third countri es on scientific an d technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on sound management of chemicals in developing countries; (c) at the Executive Director's request, drawing up an opinion on any other aspects concerning the safety of substances on th eir own, in preparations or in articles. 4. The Forum shall undertake the following tasks: (a) spreading good practice and highligh ting problems at Community level; (b) proposing, coordinating and evaluating ha rmonised enforcement projects and joint inspections; (c) coordinating exchange of inspectors; (d) identifying enforcement strategies, as well as best practice in enforcement; (e) developing working methods and to ols of use to local inspectors;

183. 30.12.2006 EN Official Journal of the European Union L 396/183 (d) ensuring appropriate and timely coor dination between the Committees and the Forum; (e) concluding and managing necessary contracts with service providers; (f) the preparation of the statement of re venue and expenditure and the implementation of the budget of the Agency pur suant to Articles 96 and 97; (g) all staff matters; (h) providing the secretariat for the Management Board; (i) preparing draft opinions of the Management Board concerning the proposed rules of procedure of the Committees and of the Forum; (j) making arrangements, upon request from the Management Board, for the execution of any further function(s) (within the remit of Article 77) allotted to the Agency by delegation from the Commission; (k) establishing and maintaining a regular dialogue with the European Parliament; (l) determining the terms and conditions for use of software packages; (m) rectifying a decision made by the Agency following an appeal and after consulting the Chairman of the Board of Appeal.

184. L 396/184 EN Official Journal of the European Union 30.12.2006 3. Each year, the Executive Director shall subm it the following to the Management Board for approval: (a) a draft report covering th e activities of the Agency in the previous year, including information about the number of regist ration dossiers receiv ed, the number of substances evaluated, the number of app lications for authorisation received, the number of proposals for restriction re ceived by the Agency and opined upon, the time taken for completion of the associ ated procedures, and the substances authorised, dossiers rejecte d, substances restricted; complaints received and the action taken; an overview of the activities of the Forum; (b) a draft work-programme for the coming year; (c) the draft annual accounts; (d) the draft forecast budget for the coming year; (e) a draft multi-annual work programme. The Executive Director shall, following a pproval by the Management Board, forward the work programme for the coming year and the multi-annual work programme to the Member States, the European Parliament, th e Council and the Commission, and shall have them published. The Executive Director shall, following a pproval by the Management Board, forward the Agency's general report to the Member States , the European Parliament, the Council, the Commission, the European Economic and Soci al Committee and the Court of Auditors, and shall have it published.

187. 30.12.2006 EN Official Journal of the European Union L 396/187 Members of the Committees shall be appointed for a term of three years which shall be renewable. The members of the Management Board may not be members of the Committees. The members of each Committee may be accompan ied by advisers on scientific, technical or regulatory matters. The Executive Director or his representative and representa tives of the Commission shall be entitled to attend all the meetings of the Committees and working groups convened by the Agency or its committees as observers. St akeholders may also be invited to attend meetings as observers, as appropriate, at the request of the Committee members, or the Management Board. 5. The members of each Committee appointed fo llowing nomination by a Member State shall ensure that there is appropria te coordination between the tasks of the Agency and the work of their Member State competent authority. 6. The members of the Committees shall be supported by the scientific and technical resources available to the Member States. To this end, Member States shall provide adequate scientific and techni cal resources to the members of the Committees that they have nominated. Each Member State competent authority shall facilitate the activities of the Committees and their working groups. 7. The Member States shall refrain from gi ving the members of the Committee for Risk Assessment or of the Committee for Socio-Econ omic Analysis, or their scientific and technical advisers and experts, any instruction which is incompatible with the individual tasks of those persons or with the tasks, responsib ilities and independe nce of the Agency.

189. 30.12.2006 EN Official Journal of the European Union L 396/189 The members of the Forum may be accompanie d by scientific and technical advisers. The Executive Director of the Agency or hi s representative and representatives of the Commission shall be entitled to attend all the meetings of the Forum and its working groups. Stakeholders may also be invited to attend meetings as observers, as appropriate, at the request of Forum members, or the Management Board. 2. The members of the Forum appointed by a Me mber State shall ensure that there is appropriate coordination between the tasks of the Forum and the work of their Member State competent authority. 3. The members of the Forum shall be supporte d by the scientific a nd technical resources available to the competent authorities of the Member States. Each Member State competent authority shall facil itate the activities of the Fo rum and its working groups. The Member States shall refrain from giving th e Forum members, or their scientific and technical advisers and experts any instruction which is incompatible with the individual tasks of those persons or with the task s and responsibilities of the Forum. 4. The Forum shall draft a proposal for its own rules of procedure, to be adopted by the Management Board, within six months of the Forum first being appointed. These rules shall in particular lay down th e procedures for appointing and replacing the Chairman, replacing members and the procedur es for delegating certain tasks to working groups.

191. 30.12.2006 EN Official Journal of the European Union L 396/191 3. The provision of services by Committee me mbers or any expert serving on a working group of the Committees or Forum, or performi ng any other task for the Agency shall be governed by a written contract between the Agency and the person concerned, or where appropriate between the Agency and the employer of the person concerned. The person concerned, or his employer, shall be remunerated by the Agency in accordance with a scale of fees to be included in the financial a rrangements established by the Management Board. Where the person concerne d fails to fulfil his duties, the Executive Director has the right to te rminate or suspend the contra ct or withhold remuneration. 4. The provision of services for which there are several potential providers may require a call for an expression of interest: (a) if the scientific and technical context allows; and (b) if it is compatible with the duties of the Agency, in particular the need to provide a high level of protection of huma n health and the environment. The Management Board shall adopt the appr opriate procedures on a proposal from the Executive Director. 5. The Agency may use the services of experts for the discharge of other specific tasks for which it is responsible.

199. 30.12.2006 EN Official Journal of the European Union L 396/199 6. The estimate shall be forwarded by the Comm ission to the European Parliament and the Council (hereinafter referred to as "the budgetary authority") together with the preliminary draft budget of the European Communities. 7. On the basis of the estimate, the Commission shall enter in the prel iminary draft budget of the European Communities the estimates it considers necessary for the establishment plan and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accor dance with Article 272 of the Treaty. 8. The budgetary authority shall au thorise the appropriations for the subsidy to the Agency. The budgetary authority shall adopt the establishment plan for the Agency. 9. The budget of the Agency shall be adopted by the Management Board. It shall become final following final adoption of the general budget of the European Communities. Where appropriate, it shall be adjusted accordingly. 10. Any modification to the budget, including the establishment plan, shall follow the procedure referred to above. 11. The Management Board shall, without delay, no tify the budgetary author ity of its intention to implement any project which may have sign ificant financial impli cations for the funding of its budget, in particular any projects relating to property such as the rental or purchase of buildings. It shall inform the Commission thereof. Where a branch of the budgetary authority has no tified its intention to deliver an opinion, it shall forward its opinion to the Management Board within a period of six weeks from the date of notification of the project.

210. L 396/210 EN Official Journal of the European Union 30.12.2006 (d) the hazard label for the substance(s), resu lting from the application of Article 23(c) to (f), of Directive 67/548/EEC; (e) specific concentration limits, where app licable, resulting from the application of Article 4(4) of Directive 67/548/EEC and Articles 4 to 7 of Directive 1999/45/EC. 2. Where the obligation under paragraph 1 results in different entries on the inventory for the same substance, the notifiers and registrants sh all make every effort to come to an agreed entry to be included in the inventory. 3. The information listed in paragraph 1 sh all be updated by the notifier(s) whenever: (a) any new scientific or tec hnical information is generated which results in a change to the classification and labe lling of the substance; (b) notifiers and registrants of differing entries for a single substance come to an agreed entry in accordance with paragraph 2.

216. L 396/216 EN Official Journal of the European Union 30.12.2006 (c) the classification and la belling of the substance; (d) physicochemical data concerning the subs tance and on pathways and environmental fate; (e) the result of each toxicologi cal and ecotoxicological study; (f) any derived no-effect level (DNEL) or predicted no-effect concentration (PNEC) established in accordance with Annex I; (g) the guidance on safe use provided in accord ance with sections 4 and 5 of Annex VI; (h) analytical methods if requested in acco rdance with Annexes IX or X which make it possible to detect a dangerous substance wh en discharged into the environment as well as to determine the di rect exposure of humans. 2. The following information on substances whet her on their own, in preparations or in articles, shall be made publicly available, fr ee of charge, over the Internet in accordance with Article 77(2)(e) except where a pa rty submitting the information submits a justification in accordance w ith Article 10(a)(xi), accepted as valid by the Agency, as to why such publication is potentially harmful for the commercial interests of the registrant or any other party concerned: (a) if essential to classification and label ling, the degree of purity of the substance and the identity of impurities and/or add itives which are known to be dangerous;

217. 30.12.2006 EN Official Journal of the European Union L 396/217 (b) the total tonnage band (i.e. 1-10 t onnes, 10-100 tonnes, 100-1 000 tonnes or over 1 000 tonnes) within which a particul ar substance has been registered; (c) the study summaries or robust study summari es of the information referred to in paragraph 1(d) and (e); (d) information, other than that listed in para graph 1, contained in the safety data sheet; (e) the trade name(s) of the substance; (f) the name in the IUPAC Nomenclature for non-phase-in substances which are dangerous within the meaning of Directiv e 67/548/EEC for a period of six years; (g) the name in the IUPAC Nomenclature fo r dangerous substances within the meaning of Directive 67/548/EEC that are only used as one or more of the following: (i) as an intermediate; (ii) in scientific research and development; (iii) in product and process orient ated research and development.

228. L 396/228 EN Official Journal of the European Union 30.12.2006 2. The requests to manufacturers and importers to submit information to the Commission made by a Commission Regulation in applica tion of Article 12(2) of Regulation (EEC) No 793/93, shall be considered as decisions ad opted in accordance with Article 52 of this Regulation. The Agency shall identify the comp etent authority for th e substance to carry out the tasks of Article 46(3) a nd Article 48 of this Regulation. 3. A Member State whose rapporteur has not forwarded by 1 June 2008 the risk evaluation and, where appropriate, the strategy for limiting th e risks, in accordance with Article 10(3) of Regulation (EEC) No 793/93, shall: (a) document information on hazard and risk in accordance with Annex XV, Part B of this Regulation; (b) apply Article 69(4) of this Regulation on the basis of the information referred to in point (a); and (c) prepare a documentation of how it consid ers that any other ri sks identified would need to be addressed by action other than an amendment of Annex XVII of this Regulation. The information referred to above shall be s ubmitted to the Agency by 1 December 2008.

231. 30.12.2006 EN Official Journal of the European Union L 396/231 2. The Commission may present legislative proposals as soon as a practicable and cost-efficient way of selecting polymers for registration on the basis of sound technical and valid scientific criteria can be established, and after publishing a report on the following: (a) the risks posed by polymers in comparison with other substances; (b) the need, if any, to register cert ain types of polymer, taking account of competitiveness and innovation on the one hand and the protection of human health and the environment on the other. 3. The report, referred to in Article 117(4), on the experience acquired with the operation of this Regulation shall include a review of the requirements relating to registration of substances manufactured or imported only in quantities starting at 1 tonne but less than 10 tonnes per year per manufacturer or impor ter. On the basis of that review, the Commission may present legislat ive proposals to modify the information requirements for substances manufactured or imported in qua ntities of 1 tonne or more up to 10 tonnes per year per manufacturer or importer, taki ng into account the latest developments, for example in relation to alternative testi ng and (quantitative) structure-activity relationships ((Q)SARs). 4. The Commission shall carry out a review of Annexes I, IV and V by 1 June 2008, with a view to proposing amendments, if appropriate , to them in accordance with the procedure referred to in Article 131.

232. L 396/232 EN Official Journal of the European Union 30.12.2006 5. The Commission shall carry out a review of Annex XIII by 1 December 2008, to assess the adequacy of the criteria for identifying subs tances which are persistent, bioaccumulative and toxic or very persistent and very bio accumulative, with a view to proposing an amendment to it, if appropriate, in accordance with the procedure referred to in Article 133(4). 6. By 1 June 2012 the Commission shall carry out a review to assess whet her or not to amend the scope of this Regulation to avoid overlap s with other relevant Community provisions. On the basis of that review, the Commission may, if appropriate, present a legislative proposal. 7. By 1 June 2013 the Commission shall carry out a review to assess wh ether or not, taking into account latest developmen ts in scientific knowledge, to extend the scope of Article 60(3) to substances identified under Artic le 57(f) as having endocrine disrupting properties. On the basis of that review the Commission may, if appropriate, present legislative proposals. 8. By 1 June 2019, the Commission shall carry ou t a review to assess whether or not to extend the scope of Article 33 to cover other dangerous substa nces, taking into account the practical experience in implementing that Ar ticle. On the basis of that review, the Commission may, if appropriate, present legislative proposals to extend that obligation. 9. In accordance with the objective of promoti ng non-animal testing and the replacement, reduction or refinement of animal testing required under this Re gulation, the Commission shall review the testing requi rements of Section 8.7 of Annex VIII by 1 June 2019. On the basis of this review, while ensuring a hi gh level of protection of health and the environment, the Commission may propose an amendment in accordance with the procedure referred to in Article 133(4).

235. 30.12.2006 EN Official Journal of the European Union L 396/235 LIST OF ANNEXES ANNEX I GENERAL PROVISIONS FOR ASSE SSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS ANNEX II GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS ANNEX III CRITERIA FOR SUBSTANCES REGI STERED IN QUANTITIES BETWEEN 1 AND 10 TONNES ANNEX IV EXEMPTIONS FROM THE OBLIGAT ION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a) ANNEX V EXEMPTIONS FROM THE OBLIGAT ION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b) ANNEX VI INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10 ANNEX VII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 TONNE OR MORE ANNEX VIII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE

236. L 396/236 EN Official Journal of the European Union 30.12.2006 ANNEX IX STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE ANNEX X STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE ANNEX XI GENERAL RULES FOR ADAPTA TION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X ANNEX XII GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CH EMICAL SAFETY REPORTS ANNEX XIII CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBST ANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES ANNEX XIV LIST OF SUBSTANCES SUBJECT TO AUTHORISATION ANNEX XV DOSSIERS ANNEX XVI SOCIO-ECONOMIC ANALYSIS ANNEX XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SU BSTANCES, PREPARATIONS AND ARTICLES

238. L 396/238 EN Official Journal of the European Union 30.12.2006 0.4. Substances whose physicochemical, toxicol ogical and ecotoxicolog ical properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or "category" of s ubstances. If the manufacturer or importer considers that the chemical safety assessment carried out for one substance is sufficient to assess and document that the risks arising from another substance or from a group or "category" of substances are adequately contro lled then he can use that chemical safety assessment for the other substance or group or "category" of substanc es. The manufacturer or importer shall provide a justification for this. 0.5. The chemical safety assessment shall be based on the information on the substance contained in the technical dossier and on other available and relevant information. Manufacturers or importers submitting a pr oposal for testing in accordance with Annexes IX and X shall record this under th e relevant heading of the chemical safety report. Available information from assessments carried out under ot her international and national programmes shall be included. Wher e available and appropriate, an assessment carried out under Community legislati on (e.g. risk assessments completed under Regulation (EEC) No 793/93) shall be take n into account in the development of, and reflected in, the chemical safety report. De viations from such assessments shall be justified. Thus the information to be considered incl udes information related to the hazards of the substance, the exposure arising from the manufac ture or import, the identified uses of the substance, operational conditions and risk management measures applied or recommended to downstream users to be taken into account.

239. 30.12.2006 EN Official Journal of the European Union L 396/239 In accordance with section 3 of Annex XI in some cases, it may not be necessary to generate missing information, because risk management measures and operational conditions which are necessary to control a well-characterised risk may also be sufficient to control other potential risks, which will not therefore need to be characterised precisely. If the manufacturer or importer considers th at further information is necessary for producing his chemical safety report and that this information can only be obtained by performing tests in accordance with Annex IX or X, he shall submit a proposal for a testing strategy, explaining why he considers that addi tional information is necessary and record this in the chemical safety report under th e appropriate heading. While waiting for results of further testing, he shall reco rd in his chemical safety repo rt, and include in the exposure scenario developed, the interim risk manageme nt measures that he has put in place and those he recommends to downstream users in tended to manage the risks being explored. 0.6. A chemical safety assessment performed by a manufacturer or an importer for a substance shall include the following steps in accordance with the respective sect ions of this Annex: 1. Human health hazard assessment 2. Human health hazard assessmen t of physicochemical properties 3. Environmental hazard assessment 4. PBT and vPvB assessment

240. L 396/240 EN Official Journal of the European Union 30.12.2006 If as a result of steps 1 to 4 the manufacturer or importer co ncludes that the substance or the preparation meets the criteria for classification as dangerous according to Directive 67/548/EEC or Direct ive 1999/45/EC or is assessed to be a PBT or vPvB, the chemical safety assessment shall al so consider the following steps: 5. Exposure assessment 5.1. The generation of exposure scenario(s) or the genera tion of relevant use and exposure categories if appropriate 5.2. Exposure estimation 6. Risk characterisation A summary of all the relevant information us ed in addressing the points above, shall be presented under the relevant heading of the Chemical Safety Report (Section 7). 0.7. The main element of the exposure part of the chemical safety report is the description of the exposure scenario(s) implemented for th e manufacturer's production, the manufacturer or importer's own use, and those recommende d by the manufacturer or importer to be implemented for the identified use(s). An exposure scenario is the set of conditi ons that describe how the substance is manufactured or used during its life-cycle a nd how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. These sets of conditions contai n a description of both the risk management measures and operational conditions which the manufactur er or importer has implemented or recommends to be implemented by downstream users.

241. 30.12.2006 EN Official Journal of the European Union L 396/241 If the substance is placed on the market, the relevant exposure scen ario(s), including the risk management measures and operational conditi ons shall be included in an annex to the safety data sheet in accordance with Annex II. 0.8. The level of detail required in describing an exposure scenario will vary substantially from case to case, depending on the use of a substa nce, its hazardous properties and the amount of information available to the manufacturer or importer. Exposure scenarios may describe the appropriate risk management measures for several individual proc esses or uses of a substance. An exposure scenario may thereby cover a large range of processes or uses. Exposure scenarios covering a wide range of processes or uses may be referred to as Exposure Categories. Further mention of Expos ure Scenario in this Annex and Annex II includes Exposure Categories if they are developed. 0.9. Where information is not necessary in accordance with Annex XI, this fact shall be stated under the appropriate head ing of the chemical safety report and a reference shall be made to the justification in the technical dossier. The fact that no information is required shall also be stated in the safety data sheet. 0.10. In relation to particular effects, such as ozone depletion, photochemical ozone creation potential, strong odour and tainting, for which the procedures set out in sections 1 to 6 are impracticable, the risks associated with such effects shall be assessed on a case-by-case basis and the manufacturer or importer shall include a full description and justification of such assessments in the chemical safety report and summarised in the safety data sheet.

243. 30.12.2006 EN Official Journal of the European Union L 396/243 1.0.2. The human health hazard assessment shal l consider the toxicokinetic profile (i.e. absorption, metabolism, distribution a nd elimination) of the substance and the following groups of effects, (1) acute effects (acute toxicity, irrita tion and corrosivity), (2) sensitisation, (3) repeat ed dose toxicity and (4) CMR effects (carcinogenity, mutagenicity and toxicity for reproduction). Based on all the available information, other effects shall be considered when necessary. 1.0.3. The hazard assessment shall comprise the following four steps: Step 1: Evaluation of non-human information Step 2: Evaluation of human information Step 3: Classification and Labelling Step 4: Derivation of DNELs 1.0.4. The first three steps shall be undertaken for ev ery effect for which information is available and shall be recorded under th e relevant section of the Chemical Safety Report and where required and in accordance with Article 31, summarised in the Safety Data Sheet under headings 2 and 11. 1.0.5. For any effect for which no relevant informa tion is available, the relevant section shall contain the sentence "This information is not available". The jus tification, including reference to any literature search carried out , shall be included in the technical dossier.

245. 30.12.2006 EN Official Journal of the European Union L 396/245 1.1.4. If one study is available then a robust study su mmary should be prepared for that study. If there are several studies addressing the sa me effect, then, having taken into account possible variables (e.g. conduct, adequacy, relevance of test species, quality of results, etc.), normally the study or studies givi ng rise to the highest concern shall be used to establish the DNELs and a robust study summ ary shall be prepared for that study or studies and included as part of the technical dossier. Robust summaries will be required of all key data used in the hazard assessment. If the study or studies giving rise to the highest concern are not used, then this shall be fully justified and included as part of the technical dossier, not only for the study be ing used but also for all st udies demonstrating a higher concern than the study being used. It is impor tant irrespective of whether hazards have been identified or not that the va lidity of the study be considered. 1.2. Step 2: Evaluation of human information If no human information is available, this part shall contain th e statement "No human information is available". However, if human in formation is available, it shall be presented, if possible in the form of a table. 1.3. Step 3: Classification and Labelling 1.3.1. The appropriate classification and labelling developed in ac cordance with the criteria in Directive 67/548/EEC shall be presented and justified. Where applicable Specific Concentration limits, resulting from th e application of Article 4(4) of Directive 67/548/EEC and Article s 4 to 7 of Directive 1999/45/ EC, shall be presented and, if they are not included in Annex I to Di rective 67/548/EEC, justified. The assessment should always include a statement as to whethe r the substance fulfils or does not fulfil the criteria given in Directive 67/548/ EEC for CMR, categories 1 and 2.

248. L 396/248 EN Official Journal of the European Union 30.12.2006 2.3. The assessment of each effect shall be pr esented under the relevant heading of the Chemical Safety Report (Section 7) and wher e required and in accordance with Article 31, summarised in the Safety Data Sheet under headings 2 and 9. 2.4. For every physicochemical property, the a ssessment shall entail an evaluation of the inherent capacity of the substance to cause the effect resulting from the manufacture and identified uses. 2.5. The appropriate classification and labelling developed in ac cordance with the criteria in Directive 67/548/EEC shall be presented and justified. 3. ENVIRONMENTAL HAZARD ASSESSMENT 3.0. Introduction 3.0.1. The objective of the environmental hazard assessment shall be to determine the classification and labelling of a substance in accordance with Direct ive 67/548/EEC and to identify the concentration of the substa nce below which adverse effects in the environmental sphere of concern are not expect ed to occur. This concentration is known as the Predicted No-Effect Concentration (PNEC). 3.0.2. The environmental hazard assessment sh all consider the pot ential effects on the environment, comprising the (1) aquatic (i ncluding sediment), (2) terrestrial and (3) atmospheric compartments, including the potential effects that may occur (4) via food-chain accumulation. In addition, the pot ential effects on the (5) microbiological activity of sewage treatment systems shall be considered. The assessment of the effects on each of these five environmental spheres shall be presented under the relevant heading of the Chemical Safety Report (Section 7) a nd where required and in accordance with Article 31, summarised in the Safety Data Sheet under headings 2 and 12.

250. L 396/250 EN Official Journal of the European Union 30.12.2006 3.1.2. When it is not possible to establish the quant itative dose (concentration) – response (effect) relationship, then this should be justified a nd a semi-quantitative or qualitative analysis shall be included. 3.1.3. All information used to asse ss the effects on a specific e nvironmental sphere shall be briefly presented, if possible in the form of a table or tables. The relevant test results (e.g. LC50 or NOEC) and test c onditions (e.g. test duration, r oute of administration) and other relevant information shall be presente d, in internationally recognised units of measurement for that effect. 3.1.4. All information used to asse ss the environmental fate of th e substance shall be briefly presented, if possible in the form of a table or tables. The relevant test results and test conditions and other relevant information shall be presented, in intern ationally recognised units of measurement for that effect. 3.1.5. If one study is available then a robust study summary should be prepared for that study. Where there are more than one studies addressi ng the same effect, then the study or studies giving rise to the highest con cern shall be used to draw a conclusion and a robust study summary shall be prepared for that study or st udies and included as part of the technical dossier. Robust summaries will be required of all key data used in the hazard assessment. If the study or studies giving ri se to the highest concern are not used, then this shall be fully justified and included as part of th e technical dossier, not only for the study being used but also for all studies reaching a hi gher concern than the study being used. For substances where all available studies indicat e no hazards an overall assessment of the validity of all studies should be performed.

252. L 396/252 EN Official Journal of the European Union 30.12.2006 4. PBT AND VPVB ASSESSMENT 4.0. Introduction 4.0.1. The objective of the PBT and vPvB assessmen t shall be to determine if the substance fulfils the criteria given in Annex XIII and if s o, to characterise the potential emissions of the substance. A hazard assessment in accordan ce with Sections 1 and 3 of this Annex addressing all the long-term effects and the estimation of the long-term exposure of humans and the environment as carried out in accordance with Section 5 (Exposure Assessment), step 2 (Exposure Estimation), canno t be carried out with sufficient reliability for substances satisfying the PBT and vPvB cr iteria in Annex XIII. Therefore, a separate PBT and vPvB assessment is required. 4.0.2. The PBT and vPvB assessment shall comprise the following two steps, which shall be clearly identified as such in Part B, Section 8 of the Chemical Safety Report: Step 1: Comparison with the Criteria Step 2: Emission Characterisation The assessment shall also be summarised in the Safety Data Sheet under heading 12. 4.1. Step 1: Comparison with the Criteria This part of the PBT and vPvB assessment shall entail the comparison of the available information, which is submitted as part of the technical dossier, with the criteria given in Annex XIII and a statement of wh ether the substance fulfils or does not fulfil the criteria.

253. 30.12.2006 EN Official Journal of the European Union L 396/253 If the available information is not sufficient to decide whether the substance fulfils the criteria in Annex XIII, then other evidence lik e monitoring data available for the registrant and giving rise to an equivale nt level of concern shall be considered on a case-by-case basis. If the technical dossier contains for one or more endpoints only information as required in Annexes VII and VIII, the regi strant shall consider information relevant for screening for P, B and T properties to decide whether fu rther information needs to be generated to fulfil the objective of the PBT and vPvB asse ssment. In case the generation of further information is necessary and would require testing on vertebrate animals, the registrant shall submit a testing proposal. However, such further information does not need to be generated if the registrant implements or recommends sufficient risk management measures and operational conditions that enab le derogation according to Section 3 of Annex XI from testing relevant for PBT and vPvB assessment. 4.2. Step 2: Emission Characterisation If the substance fulfils the criteria an emission characterisation shall be conducted comprising the relevant parts of the exposur e assessment as described in Section 5. In particular it shall c ontain an estimation of the amounts of the substance released to the different environmental compartments during al l activities carried out by the manufacturer or importer and all identified uses, and an identification of the likely routes by which humans and the environment are exposed to the substance.

254. L 396/254 EN Official Journal of the European Union 30.12.2006 5. EXPOSURE ASSESSMENT 5.0. Introduction The objective of the exposure assessment sha ll be to make a quant itative or qualitative estimate of the dose/concentration of the subs tance to which humans and the environment are or may be exposed. The assessment shall c onsider all stages of the life-cycle of the substance resulting from the manufacture and id entified uses and shal l cover any exposures that may relate to the hazards identified in sections 1 to 4. The exposure assessment shall entail the following two steps, which shall be clearly identified as such in the Chemical Safety Report: Step 1: Generation of exposure scenario(s ) or the generation of relevant use and exposure categories Step 2: Exposure Estimation. Where required and in accordance with Articl e 31, the exposure scen ario shall also be included in an annex to the Safety Data Sheet. 5.1. Step 1: Development of exposure scenarios

255. 30.12.2006 EN Official Journal of the European Union L 396/255 5.1.1. Exposure scenarios as described in sectio ns 0.7 and 0.8 shall be generated. Exposure scenarios are the core of th e process to carry out a chemical safety assessment. The chemical safety assessment process may be iterative. The first assessment will be based on the required minimum and all available hazard information and on the exposure estimation that corresponds to the initi al assumptions about the operating conditions and risk management measures (an initial exposure scen ario). If the initial assumptions lead to a risk characterisation indicating that risks to human health and the environment are not adequately controlled, then it is necessary to carry out an it erative process with amendment of one or a number of factors in hazard or exposure assessment with the aim to demonstrate adequate control. The refine ment of hazard assessment may require generation of additional hazard information. The refinement of exposure assessment may involve appropriate alteration of the operationa l conditions or risk management measures in the exposure scenario or more precise exposure estimation. The exposure scenario, resulting from the final iteration (a final e xposure scenario), shall be included in the chemical safety report and attached to the safety data sheet in accordance with Article 31. The final exposure scenario shall be presented under the relevant head ing of the chemical safety report, and included in an annex to the safety data sheet, usi ng an appropriate short title giving a brief general description of the us e, consistent with those given in Section 3.5 of Annex VI. Exposure scenario s shall cover any manufactur e in the Community and all identified uses. In particular, an exposure scenario incl udes, where relevant, a description of:

257. 30.12.2006 EN Official Journal of the European Union L 396/257 5.2. Step 2: Exposure Estimation 5.2.1. The exposure shall be estimated for each exposure scenario developed and shall be presented under the relevant heading of the Chemical Safe ty Report and where required and in accordance with Article 31, summarised in an annex to the safety data sheet. The exposure estimation entails three elements: (1) emission estimation; (2) assessment of chemical fate and pathways; and (3) estimation of exposure levels. 5.2.2. The emission estimation shall consider the emissions during all relevant parts of the life-cycle of the substance resulting from the manufacture and each of the identified uses. The life-cycle stages resulting from the ma nufacture of the substance cover, where relevant, the waste stage. The life-cycle stages resulting from identified uses cover, where relevant, the service-life of articles and the waste stage. The emission estimation shall be performed under the assumption that the ri sk management measures and operational conditions described in the exposure scenario have been implemented. 5.2.3. A characterisation of possible degradation, transformation, or reaction processes and an estimation of environmental distribut ion and fate shall be performed. 5.2.4. An estimation of the exposure levels sh all be performed for all human populations (workers, consumers and humans liable to expo sure indirectly via the environment) and environmental spheres for which exposure to the substance is known or reasonably foreseeable. Each relevant route of human e xposure (inhalation, oral, dermal and combined through all relevant routes and sources of e xposure) shall be addressed. Such estimations shall take account of spatial and temporal vari ations in the exposure pattern. In particular, the exposure estimation shall take account of:

261. 30.12.2006 EN Official Journal of the European Union L 396/261 For substances satisfying the PBT and vPvB criteria, the manufacturer or importer shall use the information as obtained in Section 5, Step 2 when implem enting on its site, and recommending for downstream users, risk management measures which minimise exposures and emissions to humans and the environment, throughout the lifecycle of the substance that resu lts from manufacture or identified uses. 7. CHEMICAL SAFETY REPORT FORMAT The Chemical Safety Report shall include the following headings: C HEMICAL SAFETY REPORT FORMAT PART A 1. SUMMARY OF RISK MANAGEMENT MEASURES 2. DECLARATION THAT RISK MANAGEMENT MEASURES ARE IMPLEMENTED 3. DECLARATION THAT RISK MANAGEMENT MEASURES ARE COMMUNICATED PART B 1. IDENTITY OF THE SUBSTANC E AND PHYSICAL AND CHEMICAL PROPERTIES 2. MANUFACTURE AND USES 2.1. Manufacture 2.2. Identified uses 2.3. Uses advised against

262. L 396/262 EN Official Journal of the European Union 30.12.2006 C HEMICAL SAFETY REPORT FORMAT 3. CLASSIFICATION AND LABELLING 4. ENVIRONMENTAL FATE PROPERTIES 4.1. Degradation 4.2. Environmental distribution 4.3. Bioaccumulation 4.4. Secondary Poisoning 5. HUMAN HEALTH HAZARD ASSESSMENT 5.1. Toxicokinetics (absorption, metabol ism, distribution and elimination) 5.2. Acute toxicity 5.3. Irritation 5.3.1. Skin 5.3.2. Eye 5.3.3. Respiratory Tract 5.4. Corrosivity

263. 30.12.2006 EN Official Journal of the European Union L 396/263 C HEMICAL SAFETY REPORT FORMAT 5.5. Sensitisation 5.5.1. Skin 5.5.2. Respiratory system 5.6. Repeated dose toxicity 5.7. Mutagenicity 5.8. Carcinogenicity 5.9. Toxicity for reproduction 5.9.1. Effects on fertility 5.9.2. Developmental Toxicity

264. L 396/264 EN Official Journal of the European Union 30.12.2006 C HEMICAL SAFETY REPORT FORMAT 5.10. Other effects 5.11. Derivation of DNEL(s) 6. HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICOCHEMICAL PROPERTIES 6.1. Explosivity 6.2. Flammability 6.3. Oxidising potential 7. ENVIRONMENTAL HAZARD ASSESSMENT 7.1. Aquatic Compartment (including sediment) 7.2. Terrestrial Compartment 7.3. Atmospheric Compartment 7.4. Microbiological Activity in Sewage Treatment Systems 8. PBT AND VPVB ASSESSMENT 9. EXPOSURE ASSESSMENT 9.1. [Title of Exposure Scenario 1] 9.1.1. Exposure Scenario 9.1.2. Exposure Estimation

265. 30.12.2006 EN Official Journal of the European Union L 396/265 C HEMICAL SAFETY REPORT FORMAT 9.2. [Title of Exposure Scenario 2] 9.2.1. Exposure Scenario 9.2.2. Exposure Estimation [etc.] 10. RISK CHARACTERISATION 10.1. [Title of Exposure Scenario 1] 10.1.1. Human Health 10.1.1.1. Workers 10.1.1.2. Consumers 10.1.1.3. Indirect exposure to humans via the environment 10.1.2. Environment 10.1.2.1. Aquatic Compartment (incl. Sediment) 10.1.2.2. Terrestrial Compartment 10.1.2.3. Atmospheric Compartment 10.1.2.4. Microbiological Activity in Sewage Treatment Systems

268. L 396/268 EN Official Journal of the European Union 30.12.2006 The information in the Safety Data Sheet shall be written in a clear and concise manner. The Safety Data Sheet shall be prepared by a competent pers on who shall take into a ccount the specific needs of the user audience, as far as it is known. Pe rsons placing substances and preparations on the market shall ensure that competent persons have received appropriate tr aining, including refresher training. For preparations not classified as dangerous, but for which a Safety Data Sheet is required according to Article 31, proportionate inform ation shall be provided under each heading. Additional information may be necessary in some cas es in view of the wide range of properties of the substances and preparations. If in other cases it emerges that in formation on certain properties is of no significance or that it is tech nically impossible to provide, the r easons for this shall be clearly stated under each heading. Information shall be provi ded for each hazardous property. If it is stated that a particular hazard does not apply, clearly differentiate between cases where no information is available to the classifier, and cases wher e negative test results are available. Give the date of issue of the Safety Data Sheet on the first page. When a safety data sheet has been revised, the changes shall be brought to the attention of th e recipient and identify it as "Revision: (date)". Note Safety data sheets are also required for certain speci al substances and preparations (e.g. metals in massive form, alloys, compressed gases, etc.) li sted in chapters 8 and 9 of Annex VI to Directive 67/548/EEC, for which th ere are labelling derogations.

269. 30.12.2006 EN Official Journal of the European Union L 396/269 1. IDENTIFICATION OF THE SUBST ANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING 1.1. Identification of the substance or preparation The term used for identification shall be identi cal to that provided on the label as set out in Annex VI to Directive 67/548/EEC. For substances subject to regi stration, the term shall be cons istent with that provided under registration and the registra tion number assigned under Articl e 20(1) of this Regulation shall also be indicated. Other means of identification av ailable may also be indicated. 1.2. Use of the substance/preparation Indicate the uses of the substance or preparation as fa r as they are known. Where there are many possible uses, only the most important or common uses need to be listed. This shall include a brief description of what it actually does, e.g. flame retardant, anti-oxidant, etc. Where a Chemical Safety Report is requi red, the Safety Data Sheet shall contain information on all the identified uses relevant to the recipient of the Safety Data Sheet. This information shall be cons istent with the identified uses and exposure scenarios set out in the annex to the Safety Data Sheet.

270. L 396/270 EN Official Journal of the European Union 30.12.2006 1.3. Company/undertaking identification Identify the person responsible for placing the substance or preparation on the market within the Co mmunity, whether it is the manuf acturer, importer or distributor. Give the full address and telephone number of this person as well as the e-mail address of the competent person responsible for the Safety Data Sheet. In addition, where this person is not located in the Member State where the substance or preparation is placed on the market, give a full address and telephone number for the person responsible in that Me mber State, if possible. For registrants, the person identified shall be consistent with the information on the identity of the manufacturer or importer provided in the registration. 1.4. Emergency telephone In addition to the above mentioned inform ation, supply the emergency telephone number of the company and/or releva nt official advisory body (thi s may be the body responsible for receiving information relating to healt h, which is referred to in Article 17 of Directive 1999/45/EC). Specify if this phone nu mber is available only during office hours.

271. 30.12.2006 EN Official Journal of the European Union L 396/271 2. HAZARDS IDENTIFICATION Give here the classification of the substance or preparation which arises from application of the classification rules in Directives 67/548/EEC or 1999/45/EC. Indicate clearly and briefly the hazards the substance or prepara tion presents to man and the environment. Distinguish clearly between preparations which are classified as dangerous and preparations which are not classified as dangerous according to Directive 1999/45/EC. Describe the most important adverse physic ochemical, human health and environmental effects and symptoms relating to the uses and possible mi suses of the substance or preparation that can r easonably be foreseen. It may be necessary to mention other hazards, such as dustiness, cross-sensitisation, suffocation, freezing, high potency for odour or taste or environmental effects such as hazards to soil-dwelling organisms, ozone depletion, photochemical ozone creation potential, etc., which do not resu lt in classification but which may contribute to the overall hazards of the material. The information shown on the label shall be given under heading 15. The classification of the substance shall be consistent with the cl assification provided to the classification and labelling i nventory according to Title XI.

282. L 396/282 EN Official Journal of the European Union 30.12.2006 9. PHYSICAL AND CHEMICAL PROPERTIES To enable proper control measures to be taken, provide all relevant information on the substance or preparation, particularly the information listed under heading 9.2. The information in this section shall be consistent with the information provided in a registration where one is required. 9.1. General information Appearance Indicate the physical state (sol id, liquid, gas) and the colour of the substance or preparation as supplied. Odour If odour is perceptible, give a brief description of it. 9.2. Important health, safety and environmental information pH: Indicate the pH of the substan ce or preparation as supplied or of an aqueous solution; in the latter case, indicate the concentration. Boiling point/boiling range Flash point Flammability (solid, gas) Explosive properties Oxidising properties

290. L 396/290 EN Official Journal of the European Union 30.12.2006 Remarks Ensure that information relevant to the e nvironment is provided under other headings of the Safety Data Sheet, especially advice for controlled release, accidental release measures, transport and disposal consideratio ns under headings 6, 7, 13, 14 and 15. 13. DISPOSAL CONSIDERATIONS If the disposal of the substance or prep aration (surplus or waste resulting from the foreseeable use) presents a danger, a descrip tion of these residues and information on their safe handling shall be given. Specify the appropriate methods of disposal of both the substance or preparation and any contaminated packaging (inciner ation, recycling, landfilling, etc.) Where a Chemical Safety Report is require d, the information on the waste management measures that adequately control exposure of humans and the environment to the substance shall be consistent with the exposure scenario s set out in the annex to the Safety Data Sheet. Note Refer to any relevant Community provisions relating to waste. In their absence, it is useful to remind the user that national or regional provisions may be in force.

307. 30.12.2006 EN Official Journal of the European Union L 396/307 In addition, information on exposure, use and ri sk management measures in accordance with Article 10 and this Annex should be collected. Considering all th is information together, the registrant will be able to determine th e need to generate further information. STEP 2 – CONSIDER INFORMATION NEEDS The registrant shall identify what information is required for the registrati on. First, the relevant Annex or Annexes to be followed shall be identi fied, according to tonnage. These Annexes set out the standard information requirements, but shal l be considered in conjunction with Annex XI, which allows variation from the standard approa ch, where it can be jus tified. In particular, information on exposure, use and risk management m easures shall be considered at this stage in order to determine the information needs for the substance. STEP 3 – IDENTIFY INFORMATION GAPS The registrant shall then compare the informati on needs for the substance with the information already available and identify where there are gaps. It is important at this stage to ensure that the available data is relevant and has suffi cient quality to fulfil the requirements. STEP 4 – GENERATE NEW DATA/PROPOSE TESTING STRATEGY In some cases it will not be necessary to generate new data. However, where there is an information gap that needs to be filled, new data shall be generated (Annexes VII and VIII), or a testing strategy shall be proposed (Annexes IX and X), dependi ng on the tonnage. New tests on vertebrates shall only be conducted or proposed as a last resort when all other da ta sources have been exhausted. In some cases, the rules set out in Annexes VII to XI may require certain tests to be undertaken earlier than or in addition to the standard requirements.

310. L 396/310 EN Official Journal of the European Union 30.12.2006 2.1.1. Name(s) in the IUPAC nomenclature or other international chemical name(s) 2.1.2. Other names (usual name, trade name, abbreviation) 2.1.3. EINECS or ELINCs number (i f available and appropriate) 2.1.4. CAS name and CAS number (if available) 2.1.5. Other identity code (if available) 2.2. Information related to molecular and structural formula of each substance 2.2.1. Molecular and structural formula (inc luding Smiles notation, if available) 2.2.2. Information on optical activity and typical ra tio of (stereo) isomer s (if applicable and appropriate) 2.2.3. Molecular weight or molecular weight range 2.3. Composition of each substance 2.3.1. Degree of purity (%) 2.3.2. Nature of impurities, in cluding isomers and by-products 2.3.3. Percentage of (significant) main impurities 2.3.4. Nature and order of magnitude (... ppm, ... %) of any additives (e.g. stabilising agents or inhibitors)

312. L 396/312 EN Official Journal of the European Union 30.12.2006 3.5. Brief general description of the identified use(s) 3.6. Information on waste quantities and compositi on of waste resulting from manufacture of the substance, the use in articles and identified uses 3.7. Uses advised against (see Safety Data Sheet heading 16) Where applicable, an indication of the uses, which the registrant advises against and why (i.e. non-statutory recommendations by supplier). This need not be an exhaustive list. 4. CLASSIFICATION AND LABELLING 4.1. The hazard classification of the substance(s) , resulting from the application of Articles 4 and 6 of Directive 67/548/EEC; In addition, for each entry, the reasons why no classification is given for an endpoint should be provided (i.e. if data are lacking, in conclusive, or conclusive but not sufficient for classification); 4.2. The resulting hazard label for the substanc e(s), resulting from the application of Articles 23, 24 and 25 of Directive 67/548/EEC; 4.3. Specific concentration limits, where applic able, resulting from the application of Article 4(4) of Directive 67/548/EEC and Articles 4 to 7 of Directive 1999/45/EC.

313. 30.12.2006 EN Official Journal of the European Union L 396/313 5. GUIDANCE ON SAFE USE CONCERNING: This information shall be consistent with that in the Safety Data Sheet, where such a Safety Data Sheet is required according to Article 31. 5.1. First-aid measures (Safety Data Sheet heading 4) 5.2. Fire-fighting measures (Saf ety Data Sheet heading 5) 5.3. Accidental release measures (Safety Data Sheet heading 6) 5.4. Handling and Storage (Safety Data Sheet heading 7) 5.5. Transport information (Safety Data Sheet heading 14) Where a Chemical Safety Report is not requ ired, the following additional information is required: 5.6. Exposure Controls/Personal Protecti on (Safety Data Sheet heading 8) 5.7. Stability and Reactivity (Saf ety Data Sheet heading 10) 5.8. Disposal considerations 5.8.1. Disposal considerations (S afety Data Sheet heading 13) 5.8.2. Information on recycling and me thods of disposal for industry 5.8.3. Information on recycling and methods of disposal for the public

314. L 396/314 EN Official Journal of the European Union 30.12.2006 6. INFORMATION ON EXPOSURE FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONN ES PER YEAR PER MANUFATCURER OR IMPORTER 6.1. Main use category: 6.1.1. (a) industrial use and/or (b) professional use and/or (c) consumer use 6.1.2. Specification for industrial and professional use: (a) used in closed system and/or (b) use resulting in inclusion into or onto matrix and/or (c) non-dispersive use and/or (d) dispersive use 6.2. Significant route(s) of exposure: 6.2.1. Human exposure: (a) oral and/or (b) dermal and/or (c) inhalatory

320. L 396/320 EN Official Journal of the European Union 30.12.2006 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 performed (e.g. the substance decomposes, has a high surface activity, reacts violently during the performance of the test or does not dissolve in water or in octanol, or it is not possible to obtain a sufficiently pure substa nce), a calculated value for log P as well as details of the calculation method shall be provided. 7.9. Flash-point 7.9. The study does not need to be conducted if: – the substance is inorganic; or – the substance only contains volatile organic components with flash-points above 100°C for aqueous solutions; or – the estimated flash-point is above 200°C; or – the flash-point can be accurately predicted by interpolation from existing characterised materials.

321. 30.12.2006 EN Official Journal of the European Union L 396/321 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 7.10. Flammability 7.10. The study does not need to be conducted: – if the substance is a solid which possesses explosive or pyrophoric properties. These properties should always be consid ered before considering flammability; or – for gases, if the concentration of the flammable gas in a mixture with inert gases is so low that, when mixed with air, the concentration is all time below the lower limit; or – for substances which spontaneously i gnite when in contact with air.

323. 30.12.2006 EN Official Journal of the European Union L 396/323 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 7.12. Self-ignition temperature 7.12. The study does not need to be conducted: – if the substance is explosive or ignites spontaneously with air at room temperature; or – for liquids non flammable in air, e.g. no flash point up to 200°C; or – for gases having no flammable range; or – for solids, if the substance has a melting point < 160°C, or if preliminary results exclude self-heating of the substance up to 400°C. 7.13. Oxidising properties 7.13. The study does not need to be conducted if: – the substance is explosive; or – the substance is highly flammable; or – the substance is an organic peroxide; or – the substance is incapable of reacting e xothermically with combustible materials, for example on the basis of the chemical structure (e.g. organic substances not containing oxygen or halogen atoms and th ese elements are not chemically bonded to nitrogen or oxygen, or inorganic s ubstances not containing oxygen or halogen atoms).

332. L 396/332 EN Official Journal of the European Union 30.12.2006 8. TOXICOLOGICAL INFORMATION COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 8.1. Skin irritation 8.1.1. In vivo skin irritation 8.1.1. The study does not need to be conducted if: – the substance is classified as corrosive to the skin or as a skin irritant; or – the substance is a strong acid (pH < 2,0) or base (pH > 11,5); or – the substance is flammable in air at room temperature; or – the substance is classified as very toxic in contact with skin; or – an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2 000 mg/kg body weight).

333. 30.12.2006 EN Official Journal of the European Union L 396/333 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 8.2. Eye irritation 8.2.1. In vivo eye irritation 8.2.1. The study does not need to be conducted if: – the substance is classified as irritating to eyes with risk of serious damage to eyes; or – the substance is classified as corrosive to the skin and provided that the registrant classified the substance as eye irritant; or – the substance is a strong acid (pH < 2,0) or base (pH > 11,5); or – the substance is flammable in air at room temperature. 8.4. Mutagenicity 8.4.2. In vitro cytogenicity study in mammalian cells or in vitro micronucleus study 8.4.2. The study does not usually need to be conducted – if adequate data from an in vivo cytogenicity test are available or – the substance is known to be carcinogenic category 1 or 2 or mutagenic category 1, 2 or 3.

335. 30.12.2006 EN Official Journal of the European Union L 396/335 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 8.5.3. By dermal route 8.5.3. Testing by the dermal route is appropriate if: (1) inhalation of the substance is unlikely; and (2) skin contact in production and/or use is likely; and (3) the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin. 8.6. Repeated dose toxicity 8.6.1. Short-term repeated dose toxicity study (28 days), one species, male and female, most appropriate route of administration, having regard to the likely route of human exposure. 8.6.1. The short-term toxicity study (28 days) does not need to be conducted if: – a reliable sub-chronic (90 days) or chronic toxicity study is available, provided that an appropriate species, dosage, solvent a nd route of administration were used; or – where a substance undergoes immediate disi ntegration and there are sufficient data on the cleavage products; or – relevant human exposure can be exclude d in accordance with Annex XI section 3.

336. L 396/336 EN Official Journal of the European Union 30.12.2006 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 The appropriate route shall be chosen on the following basis: Testing by the dermal route is appropriate if: (1) inhalation of the substance is unlikely; and (2) skin contact in production and/or use is likely; and (3) the physicochemical and toxicological proper ties suggest potential for a significant rate of absorption through the skin. Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance a nd/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

337. 30.12.2006 EN Official Journal of the European Union L 396/337 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 The sub-chronic toxicity study (90 days) (Annex IX, section 8.6.2) shall be proposed by the registrant if: the frequency and duration of human exposure indicates that a longer term study is appropriate; and one of the following conditions is met: – other available data indicate that the substa nce may have a dangerous property that cannot be detected in a short-term toxicity study; or – appropriately designed toxicokinetic studies reveal accumulation of the substance or its metabolites in certain tissues or organs which would possibly remain undetected in a short-term toxicity study but which are liabl e to result in adverse effects after prolonged exposure.

338. L 396/338 EN Official Journal of the European Union 30.12.2006 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 Further studies shall be proposed by the registrant or may be required by the Agency in accordance with Article 40 or 41 in case of: – failure to identify a NOAEL in the 28 or the 90 days study, unless the reason for the failure to identify a NOAEL is absence of adverse toxic effects; or – toxicity of particular concern (e.g. serious/severe effects); or – indications of an effect for which the ava ilable evidence is inadequate for toxicological and/or risk characterisation. In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity); or – the route of exposure used in the initial rep eated dose study was inappropriate in relation to the expected route of human exposure and rout e-to-route extrapolation cannot be made; or – particular concern regarding exposure (e.g. use in consumer products leading to exposure levels which are close to the dose levels at wh ich toxicity to humans may be expected); or – effects shown in substances with a clear re lationship in molecular structure with the substance being studied, were not detected in the 28 or the 90 days study.

339. 30.12.2006 EN Official Journal of the European Union L 396/339 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 8.7. Reproductive toxicity 8.7.1. Screening for reproductive/developmental toxicity, one species (OECD 421 or 422), if there is no evidence from available information on struct urally related substances, from (Q)SAR estimates or from in vitro methods that the substance may be a developmental toxicant 8.7.1. This study does not need to be conducted if: – the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented; or – the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented; or – relevant human exposure can be excluded in accordance with Annex XI section 3; or – a pre-natal developmental toxicity stud y (Annex IX, 8.7.2) or a two-generation reproductive toxicity study (Annex IX , section 8.7.3) is available. If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as Repr Cat 1 or 2: R60, and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessar y. However, testing for development toxicity must be considered. If a substance is known to cause developmental t oxicity, meeting the criteria for classification as Repr Cat 1 or 2: R61, and the available data ar e adequate to support a robust risk assessment, then no further testing for developmental toxicity w ill be necessary. However, testing for effects on fertility must be considered.

340. L 396/340 EN Official Journal of the European Union 30.12.2006 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 In cases where there are serious concerns about th e potential for adverse effects on fertility or development, either a pre-nata l developmental toxicity study (Annex IX, section 8.7.2) or a two-generation reproductive toxicity study (Anne x IX, section 8.7.3) may be proposed by the registrant instead of the screening study. 8.8. Toxicokinetics 8.8.1. Assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information

341. 30.12.2006 EN Official Journal of the European Union L 396/341 9. ECOTOXICOLOGICAL INFORMATION COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 9.1.3. Short-term toxicity testing on fish: The registrant may consider long-term toxicity testing instead of short-term. 9.1.3. The study does not need to be conducted if: – there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes; or – a long-term aquatic toxicity study on fish is available. Long-term aquatic toxicity testing as described in Annex IX shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further effects on aquatic organisms. The choice of the appropriate test(s) w ill depend on the results of the chemical safety assessment. The long-term aquatic toxicity study on fish (Anne x IX, section 9.1.6) shall be considered if the substance is poorly water soluble.

342. L 396/342 EN Official Journal of the European Union 30.12.2006 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 9.1.4. Activated sludge respiration inhibition testing 9.1.4. The study does not need to be conducted if: – there is no emission to a sewage treatment plant; or – there are mitigating factors indicating that microbial toxicity is unlikely to occur, for instance the substance is highly insoluble in water; or – the substance is found to be readily biodegradable and the applied test concentrations are in the range of concen trations that can be expected in the influent of a sewage treatment plant. The study may be replaced by a nitrification inhi bition test if available data show that the substance is likely to be an inhibitor of microbi al growth or function, in particular nitrifying bacteria. 9.2. Degradation 9.2. Further degradation testing shall be c onsidered if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance. The choice of the appropriate test(s ) will depend on the results of the chemical safety assessment.

346. L 396/346 EN Official Journal of the European Union 30.12.2006 7. INFORMATION ON THE PHYSICOCHEMICA L PROPERTIES OF THE SUBSTANCE COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 7.15. Stability in organic solvents and identity of relevant degradation products Only required if stability of the substance is considered to be critical. 7.15. The study does not need to be conducted if the substance is inorganic. 7.16. Dissociation constant 7.16. The study does not need to be conducted if: – the substance is hydrolytically unstable (hal f-life less than 12 hours) or is readily oxidisable in water; or – it is scientifically not possible to perform the test for instance if the analytical method is not sensitive enough. 7.17. Viscosity

355. 30.12.2006 EN Official Journal of the European Union L 396/355 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 9.2. Degradation 9.2. Further biotic degradation t esting shall be proposed by the registrant if the chemical safety assessment according to Anne x I indicates the need to investigate further the degradation of the substance and its degradation products. The choice of the appropriate test(s) depends on the results of the chemical safety assessment and may include simulation testing in appropri ate media (e.g. water, sediment or soil). 9.2.1. Biotic 9.2.1.2. Simulation testing on ultimate degradation in surface water 9.2.1.2. The study need not be conducted if: – the substances is highly insoluble in water; or – the substance is readily biodegradable.

356. L 396/356 EN Official Journal of the European Union 30.12.2006 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 9.2.1.3. Soil simulation testing (for substances with a high potential for adsorption to soil) 9.2.1.3. The study need not be conducted: – if the substance is readily biodegradable; or – if direct and indirect exposure of soil is unlikely. 9.2.1.4. Sediment simulation t esting (for substances with a high potential for adsorption to sediment) 9.2.1.4. The study need not be conducted: – if the substance is readily biodegradable; or – if direct and indirect exposure of sediment is unlikely. 9.2.3. Identification of degrada tion products 9.2.3. Unless the su bstance is readily biodegradable

357. 30.12.2006 EN Official Journal of the European Union L 396/357 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 9.3. Fate and behaviour in the environment 9.3.2. Bioaccumulation in aquatic species, preferably fish 9.3.2. The study need not be conducted if: – the substance has a low potential fo r bioaccumulation (for instance a log Kow < 3) and/or a low potential to cross biological membranes; or – direct and indirect exposure of the aquatic compartment is unlikely. 9.3.3. Further information on adsorption/desorption depending on the results of the study required in Annex VIII 9.3.3. The study need not be conducted if: – based on the physicochemical propertie s the substance can be expected to have a low potential for adsorption (e .g. the substance has a low octanol water partition coefficient); or – the substance and its degrada tion products decompose rapidly.

358. L 396/358 EN Official Journal of the European Union 30.12.2006 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 9.4. Effects on terrestrial organisms 9.4. These studies do not need to be conducted if direct and indirect exposure of the soi l compartment is unlikely. In the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied to assess the hazard to soil organisms. The choice of the appropriate tests depends on the outcome of the chemical safety assessment. In particular for substances that have a hi gh potential to adsorb to soil or that are very persistent, the registrant shall consid er long-term toxicity testing instead of short-term. 9.4.1. Short-term toxicity to invertebrates 9.4.2. Effects on soil micro-organisms 9.4.3. Short-term toxicity to plants

366. L 396/366 EN Official Journal of the European Union 30.12.2006 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 8.7.2. Developmental toxici ty study, one species, most appropriate route of administration, having regard to the likely route of human exposure (OECD 414). 8.7.3. Two-generation reproductive toxicity study, one species, male and female, most appropriate route of administration, having regard to the likely route of human exposure, unless already provided as part of Annex IX requirements

367. 30.12.2006 EN Official Journal of the European Union L 396/367 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 8.9.1. Carcinogenicity study 8.9.1. A carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if: – the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure; and – the substance is classified as mutagen category 3 or there is evidence from the repeated dose study(ies) that the substan ce is able to induce hyperplasia and/or pre-neoplastic lesions. If the substances is classified as mutagen categor y 1 or 2, the default presumption would be that a genotoxic mechanism for carcinogenicity is likely. In these cases, a carcinogenicity test will normally not be required.

368. L 396/368 EN Official Journal of the European Union 30.12.2006 9. ECOTOXICOLOGICAL INFORMATION COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 9.2. Degradation 9.2. Further biotic degradation testing shall be proposed if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance and its degradation products. The choice of the appropriate test(s) depends on the results of the chemical safety assessment and may include simulation testing in appropriate media (e.g. water, sediment or soil). 9.2.1. Biotic 9.3. Fate and behaviour in the environment 9.3.4. Further information on the environmental fate and behaviour of the substance a nd/ore degradation products 9.3.4. Further testing shall be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if the ch emical safety assessment according to Annex I indicates the need to investigat e further the fate and behaviour of the substance. The choice of the appropriate test(s) depends on the results of the chemical safety assessment.

369. 30.12.2006 EN Official Journal of the European Union L 396/369 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 9.4. Effects on terrestrial organisms 9.4. Long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assessment according to Annex I indicates th e need to investigat e further the effects of the substance and/or degradation products on terrestrial organisms. The choice of the appropriate test(s) depends on the outcome of the chemical safety assessment. These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely. 9.4.4. Long-term toxicity testing on invertebrates, unless already provided as part of Annex IX requirements. 9.4.6. Long-term toxicity testing on plants, unless already provided as part of Annex IX requirements. 9.5.1. Long-term toxicity to sediment organisms 9.5.1. Long-term toxicity testing shall be proposed by the registrant if the re sults of the chemical safety assessment indicates the need to inves tigate further the effects of the substance and/or relevant degradation pr oducts on sediment organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment. 9.6.1. Long-term or reproductive toxicity to birds 9.6.1. Any need for testing should be carefully considered taking into accou nt the large mammalian dataset that is usually available at this tonnage level.

372. L 396/372 EN Official Journal of the European Union 30.12.2006 Data shall be considered to be equivalent to data generated by the corresponding test methods referred to in Article 13(3 ) if the following conditions are met: 1) adequacy for the purpose of classifica tion and labelling and/or risk assessment; 2) sufficient documentation is provided to assess the adequacy of the study; and 3) the data are valid for the endpoint bei ng investigated and th e study is performed using an acceptable level of quality assurance. 1.1.2. Data on human health and environmental pr operties from experiments not carried out according to GLP or the test met hods referred to in Article 13(3) Data shall be considered to be equivalent to data generated by the corresponding test methods referred to in Article 13(3) if the following conditions are met: 1) adequacy for the purpose of classifica tion and labelling and/or risk assessment; 2) adequate and reliable covera ge of the key parameters foreseen to be investigated in the corresponding test methods referred to in Article 13(3); 3) exposure duration comparable to or l onger than the corresponding test methods referred to in Article 13(3) if exposure duration is a relevant parameter; and 4) adequate and reliable document ation of the study is provided.

373. 30.12.2006 EN Official Journal of the European Union L 396/373 1.1.3. Historical human data Historical human data, such as epidemiol ogical studies on exposed populations, accidental or occupational exposure data and clin ical studies, shall be considered. The strength of the data for a specific human health effect depends, among other things, on the type of analysis and on the parameters c overed and on the magnitude and specificity of the response and consequently the predictability of the effect. Criteria for assessing the adequacy of the data include: 1) the proper selection and characterisation of the expos ed and control groups; 2) adequate characteri sation of exposure; 3) sufficient length of follow-up for disease occurrence; 4) valid method for observing an effect; 5) proper consideration of bias and confounding factors; and 6) a reasonable statis tical reliability to ju stify the conclusion. In all cases adequate and reliable documentation shall be provided.

380. L 396/380 EN Official Journal of the European Union 30.12.2006 The process which the downstream user goes through in carrying out the chemical safety assessment and in producing his Chemical Safety Report, involves three steps: Step 1: Development of exposure scenario(s) The downstream user shall develop exposure scenario s for uses not covered in a Safety Data Sheet supplied to him in accordance w ith Section 5 of Annex I. Step 2: If necessary, a refinement of the hazard assessm ent by the supplier; If the downstream user considers the hazard and PBT assessments reported in the Safety Data Sheet supplied to him to be appropriate , then no further hazard assessm ent or PBT and vPvB assessment is necessary. In this case he shal l use the relevant information reported by the supplier for the risk characterisation. This shall be stated in the Chemical Safety Report. If the downstream user considers the assessments reported in the Safety Data Sheet supplied to him to be inappropriate, then he shall carry out the relevant assessments in accordance with Sections 1 to 4 of Annex I as appropriate to him. In those cases where the downstream user considers that information in addition to that provided by the supplier is necessary for producing his Chemical Safety Report the downstream user shall gather this information. Where this information can only be obtained by testing on vertebrate animals, he shall submit a proposal for a testi ng strategy to the Agency in accord ance with Article 38. He shall explain why he considers that additional inform ation is necessary. While waiting for results of further testing, he shall record in his chemical sa fety report the risk manage ment measures intended to manage the risks being explored that he has put in place.

381. 30.12.2006 EN Official Journal of the European Union L 396/381 On completion of any additional testing, the downs tream user shall revise the Chemical Safety Report, and his Safety Data Sheet if he is required to prepare one, as appropriate. Step 3: Risk characterisation. A risk characterisation shall be carried out for each new exposure scenario as prescribed in Section 6 of Annex I. The risk ch aracterisation shall be presented under the relevant heading of the Chemical Safety Report and summarised in the Sa fety Data Sheet under the relevant heading(s). When generating an exposure scenario it will be necessary to make initia l assumptions about the operating conditions and risk managements measures . If the initial assumptions lead to a risk characterisation indicating inadequate protection of human health and the environment, then it shall be necessary to carry out an itera tive process with amendment of one or a number of factors until adequate control can be demonstrated. This ma y require the generation of additional hazard or exposure information or appropriate alteration of the process, operating conditions or risk management measures. Therefore, iterations ma y be made between on the one hand developing and revising an (initial) exposure scenario, wh ich includes developing and implementing risk management measures, and on the other hand ge nerating further information to produce the definitive exposure scenario. The purpose of generating further information is to establish a more precise risk characterisation, ba sed on a refined hazard assessment and/or exposure assessment. The downstream user shall produce a Chemical Sa fety Report detailing his chemical safety assessment using part B, Sections 9 and 10, of the format set out in Sectio n 7 of Annex I and the other sections of this format, if appropriate.

396. L 396/396 EN Official Journal of the European Union 30.12.2006 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 2. The Member State may, for reasons of protection of human health and the environment, prohibit the use of equipment, installations and fluids covered by paragraph 1 before they are disposed of or reach the end of their service life. 3. The placing on the second-hand market of equipment, plant and fluids covered by paragraph 1 which are not intended for disposal shall be prohibited. 4. Where the Member State considers that it is not possible for technical reasons to use substitute articles, it may permit the use of PCTs and preparations thereof where the latter are solely intended, in the normal conditions of maintenance of equipment, to supplement the level of liquids containing PCTs in properly functioning existing installations purchased before 1 October 1985. 5. The Member State may, provided prior notification stating the re asons is sent to the Commission, grant derogations from the ban on the placing on the market and use of primary and intermediate substances or preparations, in so far as they consider that these derogations have no deleterious effects on human health and the environment.

403. 30.12.2006 EN Official Journal of the European Union L 396/403 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 11. Volatile esters of bromoacetic acids: Methyl bromoacetate CAS No 96-32-2 EINECS No 202-499-2 Ethyl bromoacetate CAS No 105-36-2 EINECS No 203-290-9 Propyl bromoacetate CAS No 35223-80-4 Butyl bromoacetate

404. L 396/404 EN Official Journal of the European Union 30.12.2006 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 12. 2-Naphthylamine CAS No 91-59-8 EINECS No 202-080-4 and its salts 13. Benzidine CAS No 92-87-5 EINECS No 202-199-1 and its salts 14. 4-Nitrobiphenyl CAS No 92-93-3 EINECS No 202-204-7 15. 4-Aminobiphenyl xenylamine CAS No 92-67-1 EINECS No 202-177-1 and its salts 1. Shall not be used in concentrations equal to or greater than 0,1 % by weight in substances and preparations placed on the market. However, this provision shall not apply to waste containing one or more of these substances and covered by Directives 91/689/EEC and 2006/12/EC. 2. Such substances and preparations shall not be sold to the general public. 3. Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the packaging of such preparations shall be legible and indelibly marked as follows: "Restricted to professional users".

405. 30.12.2006 EN Official Journal of the European Union L 396/405 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 16. Lead carbons: (a) Neutral anhydrous carbonate (PbCO 3 ) CAS No 598-63-0 EINECS No 209-943-4 (b) Trilead-bis(carbonate)- dihydroxide 2 Pb CO 3 - Pb(OH) 2 CAS No 1319-46-6 EINECS No 215-290-6 17. Lead sulphates (a) PbSO 4 (1:1) CAS No 7446-14-2 EINECS No 231-198-9 (b) Pb x SO 4 CAS No 15739-80-7 EINECS No 239-831-0 Shall not be used as substances and a constituent of prepara tions intended for use as paints, except for the restoration and maintenance of works of art and historic buildings and their interiors, where Member States wish to permit this on their territory, in accordance w ith the provisions of ILO Convention 13 on the use of white lead and sulphates of lead in paint.

411. 30.12.2006 EN Official Journal of the European Union L 396/411 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 20. Organostannic compounds 1. Shall not be placed on the market for use as substances and constituents of preparations when acting as biocides in free association paint. 2. Shall not be placed on the market or used as substances and constituents of preparations which act as biocides to prevent the fouling by micro-organisms, plants or animals of: (a) all craft irrespective of their length intended for use in marine, coastal, estuarine and inland waterways and lakes; (b) cages, floats, nets and any other appliances or equipment used for fish or shellfish farming; (c) any totally or partly submerged appliance or equipment. 3. Shall not be used as substances and constituents of prepara tions intended for use in the treatment of industrial waters. 21. Di-μ-oxo-di-n- butylstanniohydroxyborane dibutyltin hydrogen borate C 8 H 19 BO 3 S n (DBB) CAS No 75113-37-0 ELINCS No 401-040-5 Shall be prohibited in a concentration equal to or greater than 0,1 % in substances and constituents of preparations placed on the market. However, this provision shall not apply to this substance (DBB) or preparations containing it if these are intended solely for conversion into finish ed articles, among which this substance will no longer feature in a concentration equal to or greater than 0,1 %.

420. L 396/420 EN Official Journal of the European Union 30.12.2006 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction Owing to the development of knowledge and techniques in respect of substitutes less dangerous than cadmium and its compounds, the Commission shall, in consultation with the Member States, assess the situation at regular intervals in accordance with the procedure laid down in Article 133(3) of this Regulation.

421. 30.12.2006 EN Official Journal of the European Union L 396/421 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 24. Monomethyl – tetrachlorodiphenyl methane Trade name: Ugilec 141 CAS No 76253-60-6 1. The placing on the market and use of this substance and of prepar ations and articles containing it shall be prohibited. 2. By way of exception paragraph 1 shall not apply: (a) in the case of plant and machinery already in service on 18 June 1994 until such plant and machinery is disposed of. However, Member States may, on grounds of human health protection and environmental protection, prohibit within their territory the use of such plant or machinery before it is disposed of; (b) in the case of the maintenance of plant and machinery already in service within a Member State on 18 June 1994. 3. The placing on the second-hand market of this substance, preparations containing this substance and plant/machinery containing this substance, shall be prohibited. 25. Monomethyl-dichloro-diphenyl methane Trade name: Ugilec 121, Ugilec 21; CAS No – unknown The placing on the market and use of this substance and of prepar ations and articles containing it shall be prohibited.

428. L 396/428 EN Official Journal of the European Union 30.12.2006 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 32. Chloroform CAS No 67-66-3 EINECS No 200-663-8 33. Carbon tetrachloride- tetrachloromethane CAS No 56-23-5 EINECS No 200-262-8 34. 1,1,2 Trichloroethane 1. Shall not be used in concentrations equal to or greater than 0,1 % by weight in substances and preparations placed on the market for sale to the general public and/or in diffusive applications such as in surface cleaning and cleaning of fabrics. 2. Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the packaging of such substances and preparations containing them in concentrations equal to or greater than 0,1 % shall be legible and indelibly marked as follows: CAS No 79-00-5 EINECS No 201-166-9 "For use in industrial installations only". By way of derogation this provision shall not apply to:

429. 30.12.2006 EN Official Journal of the European Union L 396/429 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 35. 1,1,2,2 Tetrachloroethane CAS No 79-34-5 EINECS No 201-197-8 36. 1,1,1,2 Tetrachloroethane CAS No 630-20-6 37. Pentachloroethane CAS No 76-01-7 EINECS No 200-925-1 38. 1,1 Dichloroethylene CAS No 75-35-4 EINECS No 200-864-0 39. 1,1,1 Trichloroethane, methyl chloroform CAS No 71-55-6 EINECS No 200-756-3 (a) medicinal or veterinary products as defined by Directive 2001/82/EC and Directive 2001/83/EC; (b) cosmetic products as defined by Directive 76/768/EEC.

433. 30.12.2006 EN Official Journal of the European Union L 396/433 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 3. Azodyes, which are contained in Appendix 9, "List of azo dyes", shall not be placed on the market or used for colouring textile and leather artic les as a substance or constituent of preparations in concentrations higher than 0,1 % by mass. 4. The Commission shall, in the light of new scientific knowledge, re view the provisions on azocolourants. 44. Diphenylether, pentabromo derivative C 12 H 5 Br 5 O 1. Shall not be placed on the market or used as a substance or as a constituent of preparations in concen trations higher than 0,1 % by mass. 2. Articles may not be placed on the market if they, or flame-retarded parts thereof, contain this substance in concen trations higher than 0,1 % by mass. 45. Diphenylether, octabromo derivative C 12 H 2 Br 8 O 1. Shall not be placed on the market or used as a substance or as a constituent of substances or of preparations in concentrations highe r than 0,1 % by mass. 2. Articles may not be placed on the market if they, or flame-retardant parts thereof, contain this substance in concen trations higher than 0,1 % by mass.

436. L 396/436 EN Official Journal of the European Union 30.12.2006 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 47. Cement 1. Cement and cement-containing preparations shall not be used or placed on the market, if they contain, when hydrated, more than 0,0002 % soluble chromium VI of the total dry weight of the cement. 2. If reducing agents are used, then without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the packaging of cement or cement-containing preparations shall be legibly and indelibly marked with information on the packing date, as well as on the storage conditions and the storage period appropriate to maintaining the activity of the reducing agent and to k eeping the content of soluble chromium VI below the limit indicated in paragraph 1. 3. By way of derogation, paragraphs 1 and 2 shall not apply to the placing on the market for, and use in, controlled closed and totally automated processes in which cement and cement-containing preparations are handled solely by machines and in which there is no possibility of contact with the skin.

437. 30.12.2006 EN Official Journal of the European Union L 396/437 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 48. Toluene CAS No 108-88-3 Shall not be placed on the market or used as a substance or constituent of preparations in a concentration equal to or higher than 0,1 % by mass in adhesives and spray paints intended for sale to the general public. Member States shall apply these measures from 15 June 2007.

438. L 396/438 EN Official Journal of the European Union 30.12.2006 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 49. Trichlorobenzene CAS No 120-82-1 Shall not be placed on the market or used as a substance or constituent of preparations in a concentration equal to or higher than 0,1 % by mass for all uses except: — as an intermediate of synthesis, or — as a process solvent in closed chemical applications for chlorination reactions, or — in the manufacture of 1,3,5 — trinitro — 2,4,6 — triaminobenzene (TATB). Member States shall apply these measures from 15 June 2007.

442. L 396/442 EN Official Journal of the European Union 30.12.2006 Appendices 1 to 6 FOREWORD Explanations of column headings Substances: The name is the same as that used for the substance in Annex I to Directive 67/548/EEC. Whenever possible dangerous substances are designated by their EINECS (European Inventory of Existing Commercial Chemical Substances) or ELINCS (European List of Notified Chemical Substances) names. These are referred to as EC numbers in the table. Other entries not listed in EINECS or ELI NCS are designated using an internationally recognised chemical name (e.g. ISO, IUPAC). An additional common name is included in some cases. Index number: The index number is the identification code given to the substance in Annex I of Directive 67/548/EEC. Substances are listed in the Appendix according to this index number.

443. 30.12.2006 EN Official Journal of the European Union L 396/443 EINECS number: For each substance listed in the EINECS there is an identification code. The code starts at 200-001 8. ELINCS number For each new substance notified under the Dire ctive 67/548/EEC an identification code has been defined and published in the EL INCS. The code starts at 400-010-9. CAS number: Chemical Abstracts Service (CAS) numbers have been defined for substances to help in their identification. Notes: The full text of the notes can be f ound in the Foreword of Annex I to Directive 67/548/EEC. The notes to be taken into account for the pur poses of this Regulation are the following: Note A: The name of the substance must appear on the label in the form of one of the designations given in Annex I to Directiv e 67/548/EEC (see Article 23(2)(a) of that Directive).

444. L 396/444 EN Official Journal of the European Union 30.12.2006 In Annex I to Directive 67/548/EEC, use is some times made of a general description such as "...compounds" or "...salts". In this case, the manufacturer or any other person who places such a substance on the market is require d to state on the label the correct name, due account being taken of the Chapte r entitled "Nomenclature" of the Foreword to that Annex. Directive 67/548/EEC also requires that the symbols, indications of danger, R- and S-phrases to be used for each substance shall be those shown in Annex I to that Directive (Article 23(2)(c), (d ) and (e) of that Directive). For substances belonging to one particular group of substances included in Annex I to Directive 67/548/EEC, the symbols, indications of danger, R- a nd S-phrases to be used for each substance shall be those shown in the appropriate entry in that Annex. For substances belonging to more than one group of substances incl uded in Annex I to Directive 67/548/EEC, the symbols, indications of danger, R- a nd S-phrases to be used for each substance shall be those shown in both the appropriate entries given in that Annex. In cases where two different classifications are given in the two entries for the same hazard, the classification reflecting the more seve re hazard classification shall be used. Note C: Some organic substances may be marketed either in a specif ic isomeric form or as a mixture of several isomers.

445. 30.12.2006 EN Official Journal of the European Union L 396/445 Note D: Certain substances which are susceptible to spontaneous polymerisation or decomposition are generally placed on the market in a stabilised fo rm. It is in this form that they are listed in Annex I to Directive 67/548/EEC. However, such substances are sometimes placed on the market in a non-stabilised form. In this case, the manufacturer or any person who places such a substance on the market must state on the label the name of the substance followed by the words "non-stabilised". Note E: Substances with specific effects on huma n health (see chapter 4 of Annex VI of Directive 67/548/EEC) that are classified as carcinogenic, mutagenic and/or toxic for reproduction in categories 1 or 2 are ascribed Note E if they are also classified as very toxic (T+), toxic (T) or harmful (Xn). For these substances, the risk phrases R20, R21, R22, R23, R24, R25, R26, R27, R28, R39, R 68 (harmful), R48 and R65 and all combinations of these risk phrases sh all be preceded by the word "Also". Note H: The classification and label show n for this substance applies to the dangerous property(ies) indicated by the risk phrase(s) in combinati on with the category(ies) of danger shown. The requirements of Article 6 of Directive 67/ 548/EEC on manufacturers, distributors, and importers of this substance a pply to all other aspects of cl assification and labelling. The final label shall follow the requirements of section 7 of Annex VI to Directive 67/548/EEC. This note applies to certain co al- and oil-derived substances and to certain entries for groups of substances in Anne x I to Directive 67/548/EEC.

446. L 396/446 EN Official Journal of the European Union 30.12.2006 Note J: The classification as a carcinogen need not a pply if it can be shown that the substance contains less than 0,1 % w/w benzene (EINECS No 200-753-7). Note K: The classification as a carcinoge n or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w 1,3- butadiene (EINECS No 203-450-8). If the substance is not classified as a carcinogen or mutagen, at least the S-phrases (2-)9-16 should apply. This note applies to certain comp lex oil-derived substances in Annex I to Directive 67/548/EC Note L: The classification as a carcinogen need not a pply if it can be shown that the substance contains less than 3 % DMSO extract as measured by IP 346. Note M: The classification as a carcinogen need not a pply if it can be shown that the substance contains less than 0,005 % w/w benz o[a]-pyrene (EINECS No 200-028-5).

448. L 396/448 EN Official Journal of the European Union 30.12.2006 Appendix 1 Point 28 – Carcinogens: category 1 Substances Index number EC number CAS number Notes Chromium (VI) trioxide 024-001-00-0 215-607-8 1333-82-0 E Zinc chromates including zinc potassium chromate 024-007-00-3 Nickel monoxide 028-003-00-2 215-215-7 1313-99-1 Nickel dioxide 028-004-00-8 234-823-3 12035-36-8 Dinickel trioxide 028-005-00-3 215-217-8 1314-06-3 Nickel sulphide 028-006-00-9 240-841-2 16812-54-7 Nickel subsulphide 028- 007-00-4 234-829-6 12035-72-2 Diarsenic trioxide; arsenic tr ioxide 033-003-00-0 215-481-4 1327-53-3 Arsenic pentoxide; arsenic oxi de 033-004-00-6 215-116-9 1303-28-2 Arsenic acid and its salts 033-005-00-1 Lead hydrogen arsenate 082-011-00-0 232-064-2 7784-40-9

451. 30.12.2006 EN Official Journal of the European Union L 396/451 Substances Index number EC number CAS number Notes Tar, coal, high-temp.; Coal tar (The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700°C) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons. May contain minor amounts of phenolic compounds and aromatic nitrogen bases.) 648-082-00-2 266-024-0 65996-89-6 Tar, coal, low-temp.; Coal oil (The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in low temperature (less than 700°C) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of condensed ring aromatic hydrocarbons, phenolic compounds, aromatic nitrogen bases, and their alkyl derivatives.) 648-083-00-8 266-025-6 65996-90-9

452. L 396/452 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Tar brown-coal; (An oil distilled from brown-coal tar. Composed primarily of aliphatic, naphthenic and one- to three-ring aromatic hydrocarbons, their alkyl derivates, heteroaromatics and one- and two-ring phenols boiling in the range of approximately 150°C to 360°C.) 648-145-00-4 309-885-0 101316-83-0 Tar, brown-coal, low temp.; (A tar obtained from low temperature carbonisation and low temperature gasification of brown coal. Composed primarily of alipha tic, naphthenic and cyclic aromatic hydrocarbons, heteroaromatic hydrocarbons and cyclic phenols.) 648-146-00-X 309-886-6 101316-84-1 Distillates (petroleum), light paraffinic; Unrefined or mildly refined base oil (A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillati on of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 and produces a finished oil with a viscosity of less than 19 10 -6 m 2 .s -1 at 40°C. It contains a relatively larg e proportion of saturated aliphatic hydrocarbons normally present in this distillation range of crude oil.) 649-050-00-0 265-051-5 64741-50-0

453. 30.12.2006 EN Official Journal of the European Union L 396/453 Substances Index number EC number CAS number Notes Distillates (petroleum), heavy paraffinic; Unrefined or mildly refined base oil (A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillati on of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 , and produces a finished oil with a viscosity of at least 19 10 -6 m 2 .s -1 at 40°C. It contains a relatively large proportion of saturated aliphatic hydrocarbons.) 649-051-00-6 265-052-0 64741-51-1 Distillates (petroleum), light naphthenic; Unrefined or mildly refined base oil (A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillati on of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 , and produces a finished oil with a viscosity of less than 19 10 -6 m 2 .s -1 at 40°C. It contains relatively few normal paraffins.) 649-052-00-1 265-053-6 64741-52-2

454. L 396/454 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (petroleum), heavy naphthenic; Unrefined or mildly refined base oil (A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillati on of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 , and produces a finished oil with a viscosity of at least 19 10 -6 m 2 .s -1 at 40°C. It contains relatively few normal paraffins.) 649-053-00-7 265-054-1 64741-53-3 Distillates (petroleum), acid-treated heavy naphthenic; Unrefined or mildly refined base oil (A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 , and produces a finished oil with a viscosity of at least 19 10 -6 m 2 .s -1 at 40°C. It contains relatively few normal paraffins.) 649-054-00-2 265-117-3 64742-18-3

455. 30.12.2006 EN Official Journal of the European Union L 396/455 Substances Index number EC number CAS number Notes Distillates (petroleum), acid-treated light naphthenic; Unrefined or mildly refined base oil (A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 , and produces a finished oil with a viscosity of less than 19 10 -6 m 2 .s -1 at 40°C. It contains relatively few normal paraffins.) 649-055-00-8 265-118-9 64742-19-4 Distillates (petroleum), acid-treated heavy paraffinic; Unrefined or mildly refined base oil (A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 , and produces a finished oil with a viscosity of at least 19 10 -6 m 2 .s -1 at 40°C.) 649-056-00-3 265-119-4 64742-20-7

456. L 396/456 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (petroleum), acid-treated light paraffinic; Unrefined or mildly refined base oil (A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 and produces a finished oil having a viscosity of less than 19 10 -6 m 2 .s -1 at 40°C.) 649-057-00-9 265-121-5 64742-21-8 Distillates (petroleum), chemically neutralised heavy paraffinic; Unrefined or mildly refined base oil (A complex combination of hydrocarbons obtained from a treating process to remove acidic materials. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 , and produces a finished oil with a viscosity of at least 19 10 -6 m 2 .s -1 at 40°C. It contains a relatively large proportion of aliphatic hydrocarbons.) 649-058-00-4 265-127-8 64742-27-4

457. 30.12.2006 EN Official Journal of the European Union L 396/457 Substances Index number EC number CAS number Notes Distillates (petroleum), chemically neutralised light paraffinic; Unrefined or mildly refined base oil (A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 , and produces a finished oil with a viscosity of less than 19 10 -6 m 2 .s -1 at 40°C.) 649-059-00-X 265-128-3 64742-28-5 Distillates (petroleum), chemically neutralised heavy naphthenic; Unrefined or mildly refined base oil (A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 , and produces a finished oil with a viscosity of at least 19 10 -6 m 2 .s -1 at 40°C. It contains relatively few normal paraffins.) 649-060-00-5 265-135-1 64742-34-3

494. L 396/494 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gases (petroleum), preflash tower off, crude distillation; Refinery gas (A complex combination produced from the first tower used in the distillation of crude o il. It consists of nitrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-162-00-X 272-881-1 68919-08-4 H, K Gases (petroleum), tar stripper off; Refinery gas (A complex combination obtained by the fractionation of reduced crude oil. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-163-00-5 272-884-8 68919-11-9 H, K Gases (petroleum), unifiner stripper off; Refinery gas (A combination of hydrogen and methane obtained by fractionation of the products from the unifiner unit.) 649-164-00-0 272-885-3 68919-12-0 H, K

495. 30.12.2006 EN Official Journal of the European Union L 396/495 Substances Index number EC number CAS number Notes Tail gas (petroleum), catalytic hydrodesulphurised naphtha separator; Refinery gas (A complex combination of hydrocarbons obtained from the hydrodesulphurisation of naphtha. It consists of hydrogen, methane, ethane, and propane.) 649-165-00-6 273-173-5 68952-79-4 H, K Tail gas (petroleum), straight-run naphtha hydrodesulphuriser; Refinery gas (A complex combination obtained from the hydrodesulphurisation of straight-run naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-166-00-1 273-174-0 68952-80-7 H, K Gases (petroleum), sponge absorber off, fluidised catalyt ic cracker and gas oil desulphuriser overhead fractionation; Refinery gas (A complex combination obtained by the fractionation of products from the fluidised catalytic cracker and gas oil desulphuriser. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-167-00-7 273-269-7 68955-33-9 H, K

496. L 396/496 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gases (petroleum), crude distillation and catalytic cracking; Refinery gas (A complex combination produced by crude distillation and catalytic cracking processes. It consists of hydrogen, hydrogen sulphide, nitrogen, carbon monoxide and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-168-00-2 273-563-5 68989-88-8 H, K Gases (petroleum), gas oil diethanolamine scrubb er off; Refinery gas (A complex combination produced by desulphurisation of gas oils with diethanolamine. It consists predominantly of hydrogen sulphide, hydrogen and aliphatic hydrocarbons having carbon numbers in the range of C 1 through C 5 .) 649-169-00-8 295-397-2 92045-15-3 H, K Gases (petroleum), gas oil hydrodesulphurisation effluent; Refinery gas (A complex combination obtained by separation of the liquid phase from the effluent from the hydrogenation reaction. It consists predominantly of hydrogen, hydrogen sulphide and aliphatic hydrocar bons having carbon numbers predominantly in the range of C 1 through C 3 .) 649-170-00-3 295-398-8 92045-16-4 H, K

497. 30.12.2006 EN Official Journal of the European Union L 396/497 Substances Index number EC number CAS number Notes Gases (petroleum), gas oil hydrodesulphurisation purge; Refinery gas (A complex combination of gases obtained from the reformer and from the purges from the hydrogenation reactor. It consists predominantly of hydrogen and aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-171-00-9 295-399-3 92045-17-5 H, K Gases (petroleum), hydrogenator effluent flash drum off; Refinery gas (A complex combination of gases obtained from flash of the effluents after the hydrogenation reaction. It consists predominantly of hydrogen and aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-172-00-4 295-400-7 92045-18-6 H, K

498. L 396/498 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gases (petroleum), naphtha steam cracking high-pressure residual; Refinery gas (A complex combination obtained as a mixture of the non-condensable portions from the product of a naphtha steam cracking process as well as residual gases obtained during the preparation of subsequent products. It consists predominantly of hydrogen and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 with which natural gas may also be mixed.) 649-173-00-X 295-401-2 92045-19-7 H, K Gases (petroleum), residue visbaking off; Refinery gas (A complex combination obtained from viscosity reduction of residues in a furnace. It consists predominantly of hydrogen sulphide and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-174-00-5 295-402-8 92045-20-0 H, K

500. L 396/500 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Tail gas (petroleum), catalytic polymerisation naphtha fractionation stabiliser; Petroleum gas (A complex combination of hydrocarbons from the fractionation stabilisation products from polymerisation of naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C 1 through C 4 .) 649-179-00-2 269-618-8 68307-99-3 H, K Tail gas (petroleum), catalytic reformed naphtha fractionation stabiliser, hydroge n sulphide-free; Petroleum gas (A complex combination of hydrocarbons obtained from fractionation stabilisation of catalytic reformed naphtha and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-180-00-8 269-619-3 68308-00-9 H, K

501. 30.12.2006 EN Official Journal of the European Union L 396/501 Substances Index number EC number CAS number Notes Tail gas (petroleum), cracked distillate hydrotreater stripper; Petroleum gas (A complex combination of hydrocarbons obtained by treating thermal cracked distillates with hydrogen in the presen ce of a catalyst. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-181-00-3 269-620-9 68308-01-0 H, K Tail gas (petroleum), straight-run distillate hydrodesulphuriser, hydrogen sulphide-free; Petroleum gas (A complex combination of hydrocarbons obtained from catalytic hydrodesulphurisation of straight run distillates and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-182-00-9 269-630-3 68308-10-1 H, K

502. L 396/502 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Tail gas (petroleum), gas oil catalytic cracking absorber; Petroleum gas (A complex combination of hydrocarbons obtained from the distillation of products from the catalytic cracking of gas oil. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-183-00-4 269-623-5 68308-03-2 H, K Tail gas (petroleum), gas recovery plant; Petroleum gas (A complex combination of hydrocarbons from th e distillation of products from miscellaneous hydrocarbon streams. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-184-00-X 269-624-0 68308-04-3 H, K Tail gas (petroleum), gas recovery plant deethaniser; Petroleum gas (A complex combination of hydrocarbons from th e distillation of products from miscellaneous hydrocarbon streams. It consists of hydrocarbon having carbon numbers predominantly in the range of C 1 through C 4 .) 649-185-00-5 269-625-6 68308-05-4 H, K

503. 30.12.2006 EN Official Journal of the European Union L 396/503 Substances Index number EC number CAS number Notes Tail gas (petroleum), hydrodesulphurised distillate and hydrodesulphurised naphtha fractionator, acid-free; Petroleum gas (A complex combination of hydrocarbons obtained from fractionation of hydrodesulphurised naphtha and distillate hydrocarbon streams and treated to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-186-00-0 269-626-1 68308-06-5 H, K Tail gas (petroleum), hydrodesulphurised vacuum gas oil stripper, hydrogen sulphide-free; Petroleum gas (A complex combination of hydrocarbons obtained from stripping stabilisation of catalytic hydrodesulphurised vacuum gas oil and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-187-00-6 269-627-7 68308-07-6 H, K

504. L 396/504 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Tail gas (petroleum), light straight-run naphtha stabiliser, hydrogen sulphide- free; Petroleum gas (A complex combination of hydrocarbons obtained from fractionation stabilisation of light straight-run naphtha and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-188-00-1 269-629-8 68308-09-8 H, K Tail gas (petroleum), propane- propylene alkylation feed prep deethaniser; Petroleum gas (A complex combination of hydrocarbons obtained from the distillation of the reaction products of propane with propylene. It consists of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-189-00-7 269-631-9 68308-11-2 H, K

508. L 396/508 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gases (petroleum), C 3-4 , isobutane- rich; Petroleum gas (A complex combination of hydrocarbons from th e distillation of saturated and unsaturated hydrocarbons usually ranging in carbon numbers from C 3 through C 6 , predominantly butane and isobutane. It consists of saturated and unsaturated hydrocarbons having carbon numbers in the range of C 3 through C 4 , predominantly isobutane.) 649-204-00-7 270-724-1 68477-33-8 H, K Distillates (petroleum), C 3-6 , piperylene-rich; Petroleum gas (A complex combination of hydrocarbons from th e distillation of saturated and unsaturated aliphatic hydrocarbons usually ranging in the carbon numbers C 3 through C 6 . It consists of saturated and unsaturated hydrocarbons having carbon numbers in the range of C 3 through C 6 , predominantly piperylenes.) 649-205-00-2 270-726-2 68477-35-0 H, K

509. 30.12.2006 EN Official Journal of the European Union L 396/509 Substances Index number EC number CAS number Notes Gases (petroleum), butane splitter overheads; Petroleum gas (A complex combination of hydrocarbons obtained from the distillation of the butane stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C 3 through C 4 .) 649-206-00-8 270-750-3 68477-69-0 H, K Gases (petroleum), C 2-3 ; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of products from a catalytic fractionation process. It contains predominantly ethane, ethylene, propane, and propylene.) 649-207-00-3 270-751-9 68477-70-3 H, K Gases (petroleum), catalytic-cracked gas oil depropaniser bottoms, C 4 -rich acid-free; Petroleum gas (A complex combination of hydrocarbons obtained from fractionation of catalytic cracked gas oil hydrocarbon stream and treated to remove hydrogen sulphide and other acidic components. It consists of hydrocarbons having carbon numbers in the range of C 3 through C 5 , predominantly C 4 .) 649-208-00-9 270-752-4 68477-71-4 H, K

510. L 396/510 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gases (petroleum), catalytic-cracked naphtha debutaniser bottoms, C 3-5 -rich; Petroleum gas (A complex combination of hydrocarbons obtained from the stabilisation of catalytic cracked naphtha. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C 3 through C 5 .) 649-209-00-4 270-754-5 68477-72-5 H, K Tail gas (petroleum), isomerised naphtha fractionation stabiliser; Petroleum gas (A complex combination of hydrocarbons obtained from the fractionation stabilisation products from isomerised naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-210-00-X 269-628-2 68308-08-7 H, K Erionite 650-012-00-0 12510-42-8 Asbestos 650-013-00-6 12001-29-5 12001-28-4 132207-32-0 12172-73-5 77536-66-4 77536-68-6 77536-67-5

511. 30.12.2006 EN Official Journal of the European Union L 396/511 Appendix 2 Point 28 – Carcinogens: category 2 Substances Index number EC number CAS number Notes Beryllium 004-001-00-7 231-150-7 7440-41-7 Beryllium compounds with the exception of aluminium beryllium silicates 004-002-00-2 Beryllium oxide 004-003-00-8 215-133-1 1304-56-9 E Sulfallate (ISO); 2-chlorallyl diethyldithiocarbamate 006-038-00-4 202-388-9 95-06-7 Dimethylcarbamoyl chloride 006-041-00-0 201-208-6 79-44-7 Diazomethane 006-068-00-8 206-382-7 334-88-3 Hydrazine 007-008-00-3 206-114-9 302-01-2 E N,N-Dimethylhydrazine 007- 012-00-5 200-316-0 57-14-7 1,2-Dimethylhydrazine 007-013-00-0 540-73-8 E Salts of hydrazine 007-014-00-6 Isobutyl nitrite 007-017-00-2 208-819-7 542-56-3 E

512. L 396/512 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Hydrazobenzene; 1,2- diphenylhydrazine 007-021-00-4 204-563-5 122-66-7 Hydrazine bis(3-carboxy-4- hydroxybenzensulfonate) 007-022-00-X 405-030-1 Hexamethylphosphoric triamide; hexamethylphosphoramide 015-106-00-2 211-653-8 680-31-9 Dimethyl sulphate 016-023-00-4 201-058-1 77-78-1 E Diethyl sulphate 016-027-00-6 200-589-6 64-67-5 1,3-Propanesultone 016-032-00-3 214-317-9 1120-71-4 Dimethylsulfamoylchloride 016-033-00-9 236-412-4 13360-57-1

513. 30.12.2006 EN Official Journal of the European Union L 396/513 Substances Index number EC number CAS number Notes Potassium dichromate 024-002-00-6 231-906-6 7778-50-9 E Ammonium dichromate 024-003-00-1 232-143-1 7789-09-5 E Sodium dichromate anhydrat e 024-004-00-7 234-190-3 10588-01-9 E Sodium dichromate, dihydrat e 024-004-01-4 234-190-3 7789-12-0 E Chromyl dichloride; chromic oxychloride 024-005-00-2 239-056-8 14977-61-8 Potassium chromate 024-006-00-8 232-140-5 7789-00-6 Calcium chromate 024-008-00-9 237-366-8 13765-19-0 Strontium chromate 024-009-00-4 232-142-6 7789-06-2 Chromium III chromate; chromic chromate 024-010-00-X 246-356-2 24613-89-6 Chromium (VI) compounds, with the exception of barium chromate and of compounds specified elsewhere in Annex I to Directive 67/548/EEC 024-017-00-8 – –

515. 30.12.2006 EN Official Journal of the European Union L 396/515 Substances Index number EC number CAS number Notes Isoprene (stabilised) 2-Methyl-1,3-butadiene 601-014-00-5 201-143-3 78-79-5 D Benzo[a]pyrene; benzo[d,e,f]chr ysene 601-032-00-3 200-028-5 50-32-8 Benzo[a]anthracene 601-033-00-9 200-280-6 56-55-3 Benzo[b]fluoranthene; benzo[e]acephenanthrylene 601-034-00-4 205-911-9 205-99-2 Benzo[j]fluoranthene 601-035-00-X 205-910-3 205-82-3 Benzo[k]fluoranthene 601-036-00-5 205-916-6 207-08-9 Dibenz[a,h]anthracene 601-041-00-2 200-181-8 53-70-3 Chrysene 601-048-00-0 205-923-4 218-01-9 Benzo[e]pyrene 601-049-00-6 205-892-7 192-97-2 1,2-Dibromoethane; ethylene dibromide 602-010-00-6 203-444-5 106-93-4 E 1,2-Dichloroethane; ethylene dichloride 602-012-00-7 203-458-1 107-06-2

517. 30.12.2006 EN Official Journal of the European Union L 396/517 Substances Index number EC number CAS number Notes Propylene oxide; 1,2-epoxypropane; methyloxirane 603-055-00-4 200-879-2 75-56-9 E 2,2'-Bioxirane; 1,2:3,4-diepoxybutan e 603-060-00-1 215-979-1 1464-53-5 2,3-Epoxypropan-1-ol; glycidol oxiranemethanol 603-063-00-8 209-128-3 556-52-5 E Phenyl glycidyl ether; 2,3-epoxypropyl phenyl ether; 1,2-epoxy-3-phenoxypropane 603-067-00-X 204-557-2 122-60-1 E Styrene oxide; (epoxyethyl)benzene; phenyloxirane 603-084-00-2 202-476-7 96-09-3 Furan 603-105-00-5 203-727-3 110-00-9 E R-2,3-epoxy-1-propanol 603- 143-00-2 404-660-4 57044-25-4 E (R)-1-chloro-2,3-epoxypropane 603-166-00-8 424-280-2 51594-55-9 4-Amino-3-fluorophenol 604- 028-00-X 402-230-0 399-95-1 5-Allyl-1,3-benzodioxole; safr ole 605-020-00-9 202-345-4 94-59-7 E 3-Propanolide; 1,3-propiolact one 606-031-00-1 200-340-1 57-57-8 4,4'- Bis(dimethylamino)benzophenone Michler's ketone 606-073-00-0 202-027-5 90-94-8 Urethane(INN); ethyl carbama te 607-149-00-6 200-123-1 51-79-6

520. L 396/520 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes o-Dianisidine based azo dyes; 4,4'- diarylazo-3,3'-dimethoxybiphenyl dyes with the exception of those mentioned elsewhere in Annex I to Directive 67/548/EEC 611-029-00-9 – – o-Tolidine based dyes; 4,4'-diarylazo- 3,3'-dimethylbiphenyl dyes, with the exception of those mentioned elsewhere in Annex I to Directive 67/548/EEC 611-030-00-4 – – 1,4,5,8-Tetraaminoanthraquinone; C.I. Disperse Blue 1 611-032-00-5 219-603-7 2475-45-8 6-hydroxy-1-(3-isopropoxypropyl)-4- methyl-2-oxo-5-[4- (phenylazo)phenylazo]-1,2-dihydro- 3-pyridinecarbonitrile 611-057-00-1 400-340-3 85136-74-9 (6-(4-hydroxy-3-(2- methoxyphenylazo)-2-sulfonato-7- naphthylamino)-1,3,5-triazin-2,4- diyl)bis[(amino-1-methylethyl)- ammonium] formate 611-058-00-7 402-060-7 108225-03-2 Trisodium-[4'-(8-acetylamino-3,6- disulfonato-2-naphthylazo)-4''-(6- benzoylamino-3-sulfonato-2- naphthylazo)bipheny l-1,3',3'',1'''- tetraolato-O, O', O'', O''']copper(II) 611-063-00-4 413-590-3 164058-22-4 (Methylenebis(4,1-phenylenazo(1-(3- (dimethylamino)propyl)-1,2-dihydro- 6-hydroxy-4-methyl-2-oxopyridine- 5,3-diyl)))-1,1'-dipyridinium dichloride dihydrochloride 611-099-00-0 401-500-5 —

524. L 396/524 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes 6-Methoxy-m-toluidine p-cresidine 612-209-00-X 204-419-1 120-71-8 E Ethyleneimine; aziridine 613-001-00-1 205-793-9 151-56-4 2-Methylaziridine; propylenei mine 613-033-00-6 200-878-7 75-55-8 E Captafol (ISO); 1,2,3,6-tetrahydro-N- (1,1,2,2-tetrachloroethylthio) phthalimide 613-046-00-7 219-363-3 2425-06-1 Carbadox (INN); methyl 3- (quinoxalin-2-ylmethylene)carbazate 1,4-dioxide; 2- (methoxycarbonylhydrazonomethyl) quinoxaline 1,4-dioxide 613-050-00-9 229-879-0 6804-07-5 A mixture of: 1,3,5-tris(3- aminomethylphenyl)-1,3,5- (1H,3H,5H)-triazine-2,4,6-trione; a mixture of oligomers of 3,5-bis(3- aminomethylphenyl)-1-poly[3,5- bis(3-aminomethylphenyl)-2,4,6- trioxo-1,3,5-(1H,3H,5H)-triazin-1- yl]-1,3,5-(1H,3H,5H)-triazine-2,4,6- trione 613-199-00-X 421-550-1 —

525. 30.12.2006 EN Official Journal of the European Union L 396/525 Substances Index number EC number CAS number Notes Acrylamide 616-003-00-0 201-173-7 79-06-1 Thioacetamide 616-026-00-6 200-541-4 62-55-5 A mixture of: N-[3-hydroxy-2-(2- methylacryloylamino- methoxy)propoxymethyl]-2- methylacrylamide; N-[2,3-Bis-(2- methylacryloylamino- methoxy)propoxymethyl]-2- methylacrylamide; methacrylamide; 2-methyl-N-(2-methyl- acryloylaminomethoxymethyl)- acrylamide; N-2,3- dihydroxypropoxymethyl)-2- methylacrylamide 616-057-00-5 412-790-8 – Distillates (coal tar), benzole fraction; Light oil (A complex combination of hydrocarbons obtained by the distillation of coal ta r. It consists of hydrocarbons having carbon numbers primarily in the range of C 4 to C 10 and distilling in the approximate range of 80°C to 160°C.) 648-001-00-0 283-482-7 84650-02-2 Tar oils, brown-coal; Light oil (The distillate from lignite tar boiling in the range of approximately 80°C to 250°C. Composed primarily of aliphatic and aromatic hydrocarbons and monobasic phenols.) 648-002-00-6 302-674-4 94114-40-6 J

526. L 396/526 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Benzol forerunnings (coal); Light oil redistillate, low boiling (The distillate from coke oven light oil having an approximate distillation range below 100°C. Composed primarily of C 4 to C 6 aliphatic hydrocarbons.) 648-003-00-1 266-023-5 65996-88-5 J Distillates (coal tar), benzole fraction, BTX-rich; Light oil redistillate, low boiling (A residue from the distillation of crude benzole to remove benzole fronts. Composed primarily of benzene, toluene and xylenes boiling in the range of approximately 75°C to 200°C.) 648-004-00-7 309-984-9 101896-26-8 J Aromatic hydrocarbons, C 6-10 , C 8 -rich; Light oil redistillate, low boiling 648-005-00-2 292-697-5 90989-41-6 J Solvent naphtha (coal), light; Light oil redistillate, low boiling 648-006-00-8 287-498-5 85536-17-0 J Solvent naphtha (coal), xylene-styrene cut; Light oil redistillate, intermediate boiling 648-007-00-3 287-502-5 85536-20-5 J

527. 30.12.2006 EN Official Journal of the European Union L 396/527 Substances Index number EC number CAS number Notes Solvent naphtha (coal), coumarone-styrene contg.; Light oil redistillate, intermediate boiling 648-008-00-9 287-500-4 85536-19-2 J Naphtha (coal), distillation residues; Light oil redistillate, high boiling (The residue remaining from the distillation of recovered naphtha. Composed primarily of naphthalene and condensation products of indene and styrene.) 648-009-00-4 292-636-2 90641-12-6 J Aromatic hydrocarbons, C 8 ; Light oil redistillate, high boiling 648-010-00-X 292-694-9 90989-38-1 J Aromatic hydrocarbons, C 8-9 , hydrocarbon resin polymerisation by-product; Light oil redistillate, high boiling (A complex combination of hydrocarbons obtained from the evaporation of solv ent under vacuum from polymerised hydrocarbon resin. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 8 through C 9 and boiling in the range of approximately 120°C to 215°C.) 648-012-00-0 295-281-1 91995-20-9 J Aromatic hydrocarbons, C 9-12 , benzene distillation; Light oil redistillate, high boiling 648-013-00-6 295-551-9 92062-36-7 J

528. L 396/528 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Extract residues (coal), benzole fraction alk., acid ext.; Light oil extract residues, low boiling (The redistillate from the distillate, freed of tar acids and tar bases, from bituminous coal high temperature tar boiling in the approximate range of 90°C to 160°C. It consists predominantly of benzene, toluene and xylenes.) 648-014-00-1 295-323-9 91995-61-8 J Extract residues (coal tar), benzole fraction alk., acd ext.; Light oil extract residues, low boiling 648-015-00-7 309-868-8 101316-63-6 J (A complex combination of hydrocarbons obtained by the redistillation of the distillate of high temperature coal tar (tar acid and tar base free). It consists predominantly of unsubstituted and substituted mononuclear aromatic hydrocarbons boiling in the range of 85°C–195°C.) Extract residues (coal), benzole fraction acid; Light oil extract residues, low boiling (An acid sludge by-product of the sulphuric acid refining of crude high temperature coal. Composed primarily of sulfuric acid and organic compounds.) 648-016-00-2 298-725-2 93821-38-6 J

529. 30.12.2006 EN Official Journal of the European Union L 396/529 Substances Index number EC number CAS number Notes Extract residues (coal), light oil alk., distillation overheads; Light oil extract residues, low boiling (The first fraction from the distillation of aromatic hydrocarbons, coumarone, naphthalene and indene rich prefactionator bottoms or washed carbolic oil boili ng substantially below 145°C. Composed primarily of C 7 and C 8 aliphatic and aromatic hydrocarbons.) 648-017-00-8 292-625-2 90641-02-4 J Extract residues (coal), light oil alk., acid ext., indene fr action; Light oil extract residues, intermediate boiling 648-018-00-3 309-867-2 101316-62-5 J Extract residues (coal), light oil alk., indene naphtha fraction; Light oil extract residues, high boiling (The distillate from aromatic hydrocarbons, coumarone, naphthalene and indene rich prefractionator bottoms or washed carbolic oils, having an approximate boiling range of 155°C to 180°C. Composed primarily of indene, indan and trimethylbenzenes.) 648-019-00-9 292-626-8 90641-03-5 J

530. L 396/530 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Solvent naphtha (coal); Light oil extract residues, high boiling (The distillate from either high temperature coal tar, coke oven light oil, or coal tar oil alkaline extract residue having an approximate distillation range of 130°C to 210°C. Composed primarily of indene and other polycyclic ring systems containing a singl e aromatic ring. May contain phenolic compounds and aromatic nitrogen bases.) 648-020-00-4 266-013-0 65996-79-4 J Distillates (coal tar), light oils, neutral fraction; Light oil extract residues, high boiling (A distillate from the fractional distillation of high temperature coal tar. Composed primarily of alkyl-substituted one ring aromatic hydrocarbons boiling in the range of approximately 135°C to 210°C. May also include unsaturated hydrocarbons such as indene and coumarone.) 648-021-00-X 309-971-8 101794-90-5 J Distillates (coal tar), light oils, acid exts.; Light oil extract residues, high boiling (This oil is a complex mixture of aromatic hydrocarbons, primarily indene, naphthalene, coumarone, phenol and o-, m- and p-cresol and boiling in the range of 140°C to 215°C.) 648-022-00-5 292-609-5 90640-87-2 J

531. 30.12.2006 EN Official Journal of the European Union L 396/531 Substances Index number EC number CAS number Notes Distillates (coal tar), light oils; Carbolic oil (A complex combination of hydrocarbons obtained by distillation of coal tar. It cons ists of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills at the approximate range of 150°C to 210°C.) 648-023-00-0 283-483-2 84650-03-3 J Tar oils, coal; Carbolic oil (The distillate from high temperature coal tar having an approximate distillation range of 130°C to 250°C. Composed primarily of naphthalene, alkylnaphthalen es, phenolic compounds, and aromatic nitrogen bases.) 648-024-00-6 266-016-7 65996-82-9 J Extract residues (coal), light oil alk., acid ext.; Carbolic oil extract residue (The oil resulting from the acid washing of alkali-washed carbolic oil to remove the minor amounts of basic compounds (tar bases). Composed primarily of indene, indan and alkylbenzenes.) 648-026-00-7 292-624-7 90641-01-3 J

532. L 396/532 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Extract residues (coal), tar oil alk.; Carbolic oil extract residue (The residue obtained from coal tar oil by an alkaline wash such as aqueous sodium hydroxide after the removal of crude coal tar acids. Composed primarily of naphthalenes and aromatic nitrogen bases.) 648-027-00-2 266-021-4 65996-87-4 J Extract oils (coal), light oil; Acid Extract (The aqueous extract produced by an acidic wash of alkali-washed carbolic oil. Composed primarily of acid salts of various aromatic nitrogen bases including pyridine, quinoline and their alkyl derivatives.) 648-028-00-8 292-622-6 90640-99-6 J Pyridine, alkyl derivs.; Crude tar bases (The complex combination of polyalkylated pyridin es derived from coal tar distillati on or as high-boiling distillates approximately above 150°C from the reaction of ammonia with acetaldehyde, formaldehyde or paraformaldehyde.) 648-029-00-3 269-929-9 68391-11-7 J

533. 30.12.2006 EN Official Journal of the European Union L 396/533 Substances Index number EC number CAS number Notes Tar bases, coal, picoline fraction; Distillate bases (Pyridine bases boili ng in the range of approximately 125°C to 160°C obtained by distillati on of neutralised acid extract of the base-containing tar fraction obtained by the distillation of bituminous coal tars. Composed chiefly of lutidines and picolines.) 648-030-00-9 295-548-2 92062-33-4 J Tar bases, coal, lutidine fraction; Distillate bases 648-031-00-4 293-766-2 91082-52-9 J Extract oils (coal), tar base, collidine fraction; Distillate bases (The extract produced by the acid extraction of bases from crude coal tar aromatic oils, neutralisation, and distillation of the bases. Composed primarily of collidines, aniline, toluidines, lutidines, xylidines.) 648-032-00-X 273-077-3 68937-63-3 J Tar bases, coal, collidine fraction; Distillate bases (The destillation fraction boiling in the range of approximately 181°C to 186°C from the crude bases obtained from the neutralised, acid-extracted base-containing tar fractions obtained by the distillation of bituminous coal tar. It contains chiefly aniline and collidines.) 648-033-00-5 295-543-5 92062-28-7 J

534. L 396/534 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Tar Bases, coal, aniline fraction; Distillate bases (The distillation fraction boiling in the range of approximately 180°C to 200°C from the crude bases obtained by dephenolating and debasing the carbolated oil from the distillation of coal tar. It contains chiefly aniline, collidines, lutidines and toluidines.) 648-034-00-0 295-541-4 92062-27-6 J Tar bases, coal, toluidine fraction; Distillate bases 648-035-00-6 293-767-8 91082-53-0 J Distillates (petroleum), alkene-alkyene manuf. pyrolysis oil, mixed with high-temp. coal tar, indene fraction; Redistillates (A complex combination of hydrocarbons obtained as a redistillate from the fractional distillation of bituminous coal high temperature tar and residual oils that are obtained by the pyrolytic production of alkenes and alkynes from petroleum products or natural gas. It consists predominantly of indene and boils in a range of approximately 160°C to 190°C.) 648-036-00-1 295-292-1 91995-31-2 J

535. 30.12.2006 EN Official Journal of the European Union L 396/535 Substances Index number EC number CAS number Notes Distillates (coal), coal tar-residual pyrolysis oils, naphthalene oils; Redistillates (The redistillate obtained from the fractional distillation of bituminous coal high temperature tar and pyrolysis residual oils and boiling in the range of approximately 190°C to 270°C. Composed primarily of substituted dinuclear aromatics.) 648-037-00-7 295-295-8 91995-35-6 J Extract oils (coal), coal tar-residual pyrolysis oils, naphthalene oil, redistillate; Redistillates 648-038-00-2 295-329-1 91995-66-3 J (The redistillate from the fractional distillation of dephenolated and debased methylnaphthalene oil obtained from bituminous coal high temperature tar and pyrolysis residual oils boiling in the approximate range of 220°C to 230°C. It consists predominantly of unsubstituted and substituted dinuclear aromatic hydrocarbons.) Extract oils (coal), coal tar-residual pyrolysis oils, naphthalene oils; Redistillates (A neutral oil obtained by debasing and dephenolating the oil obtained from the distillation of high temperature tar and pyrolysis residual oils which has a boiling range of 225°C to 255°C. Composed primarily of substituted dinuclear aromatic hydrocarbons.) 648-039-00-8 310-170-0 122070-79-5 J

536. L 396/536 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Extract oils (coal), coal tar residual pyrolysis oils, naphthalene oil, distillation residue s; Redistillates (Residue from the distillation of dephenolated and debased methylnaphthalene oil (from bituminous coal tar and pyrolysis residual oils) with a boiling range of 240°C to 260°C. Composed primarily of substituted dinuclear aromatic and heterocyclic hydrocarbons.) 648-040-00-3 310-171-6 122070-80-8 J Absorption oils, bicyclo arom. and heterocyclic hydrocarbon fraction; Wash oil redistillate (A complex combination of hydrocarbons obtained as a redistillate from the distillation of wash oil. It consists predominantly of 2-ringed aromatic and heterocyclic hydrocarbons boiling in the range of approximately 260°C to 290°C.) 648-041-00-9 309-851-5 101316-45-4 M Distillates (coal tar), upper, fluorene-rich; Wash oil redistillate (A complex combination of hydrocarbons obtained by the crystallisation of tar oil. It consists of aromatic and polycyclic hydrocarbons primarily fluorene and some acenaphthene.) 648-042-00-4 284-900-0 84989-11-7 M

537. 30.12.2006 EN Official Journal of the European Union L 396/537 Substances Index number EC number CAS number Notes Creosote oil, acenaphthene fraction, acenaphthene-free; Wash oil redistillate (The oil remaining after removal by a crystallisation process of acenaphthene from acenaphthene oil from coal tar. Composed primarily of naphthalene and al kylnaphthalenes.) 648-043-00-X 292-606-9 90640-85-0 H Distillates (coal tar), heavy oils; Heavy anthracene oil (Distillate from the fractional distillation of coal tar of bituminous coal, with boiling range of 240°C to 400°C. Composed primarily of tri- and polynuclear hydrocarbons and heterocyclic compounds.) 648-044-00-5 292-607-4 90640-86-1 Anthracene oil, acid ext.; Anthracene oil extract residue (A complex combination of hydrocarbons from the base-freed fraction obtained from the distillation of coal tar and boili ng in the range of approximately 325°C to 365°C. It contains predominantly anthracene and phenanthrene and their alkyl derivatives.) 648-046-00-6 295-274-3 91995-14-1 M

538. L 396/538 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (coal tar); Heavy anthracene oil (The distillate from coal tar having an approximate distillation range of 100°C to 450°C. Composed primarily of two to four membered condensed ring aromatic hydrocarbons, phenolic compounds, and aromatic nitrogen bases.) 648-047-00-1 266-027-7 65996-92-1 M Distillates (coal tar), pitch, heavy oils; Heavy anthracene oil (The distillate from the distillation of the pitch obtained from bituminous high temperature tar. Composed primarily of tri- and polynuclear aromatic hydrocarbons and boiling in the range of approximately 300°C to 470°C. The product may also contain heteroatoms.) 648-048-00-7 295-312-9 91995-51-6 M Distillates (coal tar), pitch; Heavy anthracene oil (The oil obtained from condensation of the vapours from the heat treatment of pitch. Composed primarily of two-to four-ring aromatic compounds boiling in the range of 200°C to greater than 400°C.) 648-049-00-2 309-855-7 101316-49-8 M

539. 30.12.2006 EN Official Journal of the European Union L 396/539 Substances Index number EC number CAS number Notes Distillates (coal tar), heavy oils, pyrene fraction; Heavy anthracene oil redistillate (The redistillate obtained from the fractional distillation of pitch distillate boiling in the range of approximately 350°C to 400°C. Consists predominantly of tri- and polynuclear aromatic and heterocyclic hydrocarbons.) 648-050-00-8 295-304-5 91995-42-5 M Distillates (coal tar), pitch, pyrene fraction; Heavy anthracene oil redistillate (The redistillate obtained from the fractional distillation of pitch distillate and boili ng in the range of approximately 380°C to 410°C. Composed primarily of tri- and polynuclear aromatic hydrocarbons and heterocyclic compounds.) 648-051-00-3 295-313-4 91995-52-7 M Paraffin waxes (coal), brown-coal high-temp. tar, carbon-treated; Coal tar extract 648-052-00-9 308-296-6 97926-76-6 M (A complex combination of hydrocarbons obtained by the treatment of lignite carbonisation tar with activated carbon for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C 12 .)

540. L 396/540 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Paraffin waxes (coal), brown-coal high-temp. tar, carbon-treated; Coal tar extract (A complex combination of hydrocarbons obtained by the treatment of lignite carbonisation tar with bentonite for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C 12 .) 648-053-00-4 308-297-1 97926-77-7 M Pitch; Pitch 648-054-00-X 263-072-4 61789-60-4 M Pitch, coal tar, high temp.; Pitch (The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30°C to 180°C. Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.) 648-055-00-5 266-028-2 65996-93-2 Pitch, coal tar, high temp., heat-treated; Pitch (The heat treated residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 80°C to 180°C. Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.) 648-056-00-0 310-162-7 121575-60-8 M

541. 30.12.2006 EN Official Journal of the European Union L 396/541 Substances Index number EC number CAS number Notes Pitch, coal tar, high temp., secondary; Pitch redistillate (The residue obtained during the distillation of high boiling fractions from bituminous coal high temperature tar and/or pitch coke oil, with a softening point of 140°C to 170°C according to DIN 52025. Composed primarily of tri- and polynuclear aromatic compounds which also contain heteroatoms.) 648-057-00-6 302-650-3 94114-13-3 M Residues (coal tar), pitch distillation; Pitch redistillate (Residue from the fractional distillation of pitch distillate boiling in the range of approximately 400°C to 470°C. Composed primarily of polynuclear aromatic hydrocarbons, and heterocyclic compounds.) 648-058-00-1 295-507-9 92061-94-4 M Tar, coal, high-temp., distillation and storage residues; Coal tar solids residue (Coke- and ash-containing solid residues that separate on distillation and thermal treatment of bituminous coal high temperature tar in distillation installa tions and storage vessels. Consists predominantly of carbon and contains a small quantity of hetero compounds as well as ash components.) 648-059-00-7 295-535-1 92062-20-9 M

542. L 396/542 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Tar, coal, storage residues; Coal tar solids residue (The deposit removed from crude coal tar storages. Composed primarily of coal tar and carbonaceous particulate matter.) 648-060-00-2 293-764-1 91082-50-7 M Tar, coal, high-temp., residues; Coal tar solids residue (Solids formed during the coking of bituminous coal to produce crude bituminous coal high temperature tar. Composed primarily of coke and coal particles, highly aromatised compounds and mineral substances.) 648-061-00-8 309-726-5 100684-51-3 M Tar, coal, high-temp., high-solids; Coal tar solids residue 648-062-00-3 273-615-7 68990-61-4 M (The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700°C) destructive distillation of coal. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons with a high solid content of coal-type materials.)

543. 30.12.2006 EN Official Journal of the European Union L 396/543 Substances Index number EC number CAS number Notes Waste solids, coal-tar pitch coking; Coal tar solids residue (The combination of wastes formed by the coking of bituminous coal tar pitch. It consists predominantly of carbon.) 648-063-00-9 295-549-8 92062-34-5 M Extract residues (coal), brown; Coal tar extract (The residue from extraction of dried coal.) 648-064-00-4 294-285-0 91697-23-3 M Paraffin waxes (coal), brown-coal- high-temp. tar; Coal tar extract (A complex combination of hydrocarbons obtained from lignite carbonisation tar by solvent crystallisation (solvent deoiling), by sweating or an adducting process. It consists predominantly of straight and branched chain saturated hydrocarbons having carbon numbers predominantly greater than C 12 .) 648-065-00-X 295-454-1 92045-71-1 M

544. L 396/544 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Paraffin waxes (coal), brown-coal- high-temp. tar, hydrotreated; Coal tar extract (A complex combination of hydrocarbons obtained from lignite carbonisation tar by solvent crystallisation (solvent deoiling), by sweating or an adducting process treated with hydrogen in the presence of a catalyst. It consists predominantly of straight and branched chain saturated hydrocarbons having carbon numbers predominantly greater than C 12 .) 648-066-00-5 295-455-7 92045-72-2 M Paraffin waxes (coal), brown-coal high-temp tar, silicic acid-treated; Coal tar extract (A complex combination of hydrocarbons obtained by the treatment of lignite carbonisation tar with silicic acid for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C 12 .) 648-067-00-0 308-298-7 97926-78-8 M

545. 30.12.2006 EN Official Journal of the European Union L 396/545 Substances Index number EC number CAS number Notes Tar, coal, low-temp., distillation residues; Tar oil, intermediate boiling (Residues from fractional distillation of low temperature coal tar to remove oils that boil in a range up to approximately 300°C. Composed primarily of aromatic compounds.) 648-068-00-6 309-887-1 101316-85-2 M Pitch, coal tar, low-temp; Pitch residue (A complex black solid or semi-solid obtained from the distillation of a low temperature coal tar. It has a softening point within the approximate range of 40°C to 180°C. Composed primarily of a complex mixture of hydrocarbons.) 648-069-00-1 292-651-4 90669-57-1 M Pitch, coal tar, low-temp., oxidised; Pitch residue, oxidised (The product obtained by air-blowing, at elevated temperature, low-temperature coal tar pitch. It has a softening-point within the approximate range of 70°C to 180°C. Composed primarily of a complex mixture of hydrocarbons.) 648-070-00-7 292-654-0 90669-59-3 M

546. L 396/546 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Pitch, coal tar, low-temp., heat-treated; Pitch residue, oxidised; Pitch residue, heat-treated (A complex black solid obtained by the heat treatment of low temperature coal tar pitch. It has a softening point within the approximate range of 50°C to 140°C. Composed primarily of a complex mixture of aromatic compounds.) 648-071-00-2 292-653-5 90669-58-2 M Distillates (coal-petroleum), condensed ring arom.; Distillates 648-072-00-8 269-159-3 68188-48-7 M (The distillate from a mixture of coal and tar and aromatic petroleum streams having an approximate distillation range of 220°C to 450°C. Composed primarily of 3- to 4-membered condensed ring aromatic hydrocarbons.) Aromatic hydrocarbons, C 20-28 , polycyclic, mixed coal-tar pitch-polyethylene-polypropylene pyrolysis-derived; Pyrolysis products (A complex combination of hydrocarbons obtained from mixed coal tar pitch-polyethylene- polypropylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C 20 through C 28 and having a softening point of 100°C to 220°C according to DIN 52025.) 648-073-00-3 309-956-6 101794-74-5 M

547. 30.12.2006 EN Official Journal of the European Union L 396/547 Substances Index number EC number CAS number Notes Aromatic hydrocarbons, C 20-28 , polycyclic, mixed coal-tar pitch-polyethylene pyrolysis-derived; Pyrolysis products (A complex combination of hydrocarbons obtained from mixed coal tar pitch-polyethylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C 20 through C 28 and having a softening point of 100°C to 220°C according to DIN 52025.) 648-074-00-9 309-957-1 101794-75-6 M Aromatic hydrocarbons, C 20-28 , polycyclic, mixed coal-tar pitch-polystyrene pyrolysis-derived; Pyrolysis products (A complex combination of hydrocarbons obtained from mixed coal tar pitch-polystyrene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C 20 through C 28 and having a softening point of 100°C to 220°C according to DIN 52025.) 648-075-00-4 309-958-7 101794-76-7 M

548. L 396/548 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Pitch, coal tar-petroleum; Pitch residues (The residue from the distillation of a mixture of coal tar and aromatic petroleum streams. A solid with a softening point from 40°C to 180°C. Composed primarily of a complex combination of three or more membered condensed ring aromatic hydrocarbons.) 648-076-00-X 269-109-0 68187-57-5 M Phenanthrene, distillation residues; Heavy anthracene oil redistillate (Residue from the distillation of crude phenanthrene boiling in the approximate range of 340°C to 420°C. It consists predominantly of phenanthrene, anthracene and carbazole.) 648-077-00-5 310-169-5 122070-78-4 M Distillates (coal tar), upper, fluorene-free; Wash oil redistillate (A complex combination of hydrocarbons obtained by the crystallisation of tar oil. It consists of aromatic polycyclic hydrocarbons, primarily diphenyl, dibenzofuran and acenaphthene.) 648-078-00-0 284-899-7 84989-10-6 M

549. 30.12.2006 EN Official Journal of the European Union L 396/549 Substances Index number EC number CAS number Notes Residues (coal tar), creosote oil distillation; Wash oil redistillate (The residue from the fractional distillation of wash oil boiling in the approximate range of 270°C to 330°C. It consists predominantly of dinuclear aromatic and heterocyclic hydrocarbons.) 648-080-00-1 295-506-3 92061-93-3 H Distillates (coal), coke-oven light oil, naphthalene cut; Naphthalene oil (The complex combination of hydrocarbons obtained from prefractionation (continuous distillation) of coke oven light oil. It consists predominantly of naphthalene, coumarone and indene and boils above 148°C.) 648-084-00-3 285-076-5 85029-51-2 J, M Distillates (coal tar), naphthalene oils, naphthalene-low; Napththalene oil redistillate (A complex combination of hydrocarbons obtained by crystallisation of naphthalene oil. Composed primarily of naphthalene, alkyl naphthalenes and phenolic compounds.) 648-086-00-4 284-898-1 84989-09-3 J, M

550. L 396/550 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (coal tar), naphthalene oil crystn. mother liquor; Naphthalene oil redistillate (A complex combination of organic compounds obtained as a filtrate from the crystallisation of the naphthalene fraction from coal tar and boiling in the range of approximately 200°C to 230°C. Contains ch iefly naphthalene, thionaphthene and alkylnaphthalenes.) 648-087-00-X 295-310-8 91995-49-2 J, M Extract residues (coal), naphthalene oil, alk.; Naphthalene oil extract residue (A complex combination of hydrocarbons obtained from the alkali washing of naphthalene oil to remove phenolic compounds (tar acids). It is composed of naphthalene and alkyl naphthalenes.) 648-088-00-5 310-166-9 121620-47-1 J, M Extract residues (coal), naphthalene oil, alk., naphthalene-low; Naphthalene oil extract residue (A complex combination of hydrocarbons remaining after the removal of naphthalene from alkali-washed naphthalene oil by a crystallisation proce ss. It is composed primarily of naphthalene and alkyl naphthalenes.) 648-089-00-0 310-167-4 121620-48-2 J, M

551. 30.12.2006 EN Official Journal of the European Union L 396/551 Substances Index number EC number CAS number Notes Distillates (coal tar), naphthalene oils, naphthalene-free, alk. exts.; Naphthalene oil extract residue (The oil remaining after the removal of phenolic compounds (tar acids) from drained naphthalene oil by an alkali wash. Composed primarily of naphthalene and al kyl naphthalenes.) 648-090-00-6 292-612-1 90640-90-7 J, M Extract residues (coal), naphthalene oil alk., distillation overheads; Naphthalene oil extract residue (The distillation from alkali-washed naphthalene oil having an approximate distillation range of 180°C to 220°C. Composed primarily of naphthalene, alkylbenzenes, indene and indan.) 648-091-00-1 292-627-3 90641-04-6 J, M Distillates (coal tar), naphthalene oils, methylnaphthalene fraction; Methylnaphthalene oil (A distillate from the fractional distillation of high temperature coal tar. Composed primarily of substituted two ring aromatic hydrocarbons and aromatic nitrogen bases boiling in the range of approximately 225°C to 255°C.) 648-092-00-7 309-985-4 101896-27-9 J, M

552. L 396/552 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (coal tar), naphthalene oils, indole-methylnaphthalene fraction; Methylnaphthalene oil 648-093-00-2 309-972-3 101794-91-6 J, M (A distillate from the fractional distillation of high temperature coal tar. Composed primarily of indole and methylnaphthalene boiling in the range of approximately 235°C to 255°C.) Distillates (coal tar), naphthalene oils, acid exts.; Methylnaphtalene oil extract residue (A complex combination of hydrocarbons obtained by debasing the methylnaphthalene fraction obtained by the disti llation of coal tar and boiling in the range of approximately 230°C to 255°C. Contains chiefly 1(2)-methylnaphthalene, naphthalene, dimethylnaphthalene and biphenyl.) 648-094-00-8 295-309-2 91995-48-1 J, M Extract residues (coal), naphthalene oil alk., distillation residues; Methylnaphthalene o il extract residue (The residue from the distillation of alkali-washed naphthalene oil having an approximate distillation range of 220°C to 300°C. Composed primarily of naphthalene, alkylnaphthalenes and aromatic nitrogen bases.) 648-095-00-3 292-628-9 90641-05-7 J, M

553. 30.12.2006 EN Official Journal of the European Union L 396/553 Substances Index number EC number CAS number Notes Extract oils (coal), acidic, tar-base free; Methylnaphthalene oil extract residue 648-096-00-9 284-901-6 84989-12-8 J, M (The extract oil boili ng in the range of approximately 220°C to 265°C from coal tar alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove tar bases. Composed primarily of alkylnaphthalenes.) Distillates (coal tar), benzole fraction, distillation residues; Wash oil (A complex combination of hydrocarbons obtained from the distillation of crude benzole (high temperature coal tar). It may be a liquid with the approximate distillation range of 150°C to 300°C or a semi-solid or solid with a melting point up to 70°C. It is composed primarily of naphthalene and alkyl naphthalenes.) 648-097-00-4 310-165-3 121620-46-0 J, M Creosote oil, acenaphthene fraction Wash oil 648-098-00-X 292-605-3 90640-84-9 H Creosote oil 648-099-00-5 263-047-8 61789-28-4 H

554. L 396/554 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Creosote oil, high- boiling distillate; Wash oil (The high-boiling distillation fraction obtained from the high temperature carbonisation of bituminous coal which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillates, removed. It is crystal free at approximately 5°C.) 648-100-00-9 274-565-9 70321-79-8 H Creosote 648-101-00-4 232-287-5 8001-58-9 H Extract residues (coal), creosote oil acid; Wash oil extract residue (A complex combination of hydrocarbons from the base-freed fraction from the distillation of coal tar, boiling in the range of approximately 250°C to 280°C. It consists predominantly of biphenyl and isomeric diphenylnaphthalenes.) 648-102-00-X 310-189-4 122384-77-4 H Anthracene oil, anthracene paste; Anthracene oil fraction (The anthracene-rich solid obtained by the crystallisation and centrifuging of anthracene oil. It is composed primarily of anthracene, carbazole and phenanthrene.) 648-103-00-5 292-603-2 90640-81-6 J, M

555. 30.12.2006 EN Official Journal of the European Union L 396/555 Substances Index number EC number CAS number Notes Anthracene oil, anthracene-low; Anthracene oil fraction (The oil remaining after the removal, by a crystallisation process, of an anthracene-rich solid (anthracene paste) from anthracene oil. It is composed primarily of two, three and four membered aromatic compounds.) 648-104-00-0 292-604-8 90640-82-7 J, M Residues (coal tar), anthracene oil distillation; Anthracene oil fraction (The residue from the fraction distillation of crude anthracene boiling in the approximate range of 340°C to 400°C. It consists predominantly of tri- and polynuclear aromatic and heterocyclic hydrocarbons.) 648-105-00-6 295-505-8 92061-92-2 J, M Anthracene oil, anthracene paste, anthracene fraction; Anthracene oil fraction (A complex combination of hydrocarbons from th e distillation of anthracene obtained by the crystallisation of anthracene oil from bituminous high temperature tar and boiling in the range of 330°C to 350°C. It contains chiefly anthracene, carbazole and phenanthrene.) 648-106-00-1 295-275-9 91995-15-2 J, M

556. L 396/556 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Anthracene oil, anthracene paste, carbazole fraction; Anthracene oil fraction (A complex combination of hydrocarbons from th e distillation of anthracene obtained by crystallisation of anthrancene oil from bituminous coal high temperature tar and boiling in the approximate range of 350°C to 360°C. It contains chiefly anthracene, carbazole and phenanthrene.) 648-107-00-7 295-276-4 91995-16-3 J, M Anthracene oil, anthracene paste, distillation lights; Anthracene oil fraction (A complex combination of hydrocarbons from th e distillation of anthracene obtained by crystallisation of anthracene oil from bituminous light temperature tar and boiling in the range of approximately 290°C to 340°C. It contains chiefly trinuclear aromatics and their dihydro derivatives.) 648-108-00-2 295-278-5 91995-17-4 J, M

557. 30.12.2006 EN Official Journal of the European Union L 396/557 Substances Index number EC number CAS number Notes Tar oils, coal, low-temp.; Tar oil, high boiling (A distillate from low-temperature coal tar. Composed primarily of hydrocarbons, phenolic compounds and aromatic nitrogen bases boiling in the range of approximately 160°C to 340°C.) 648-109-00-8 309-889-2 101316-87-4 J, M Phenols, ammonia liquor ext.; Alkaline extract (The combination of phenols extracted, using isobutyl acetate, from the ammonia liquor condensed from the gas evolved in low-temperature (less than 700°C) destructive distillation of coal. It consists predominantly of a mixture of monohydric and dihydric phenols.) 648-111-00-9 284-881-9 84988-93-2 J, M Distillates (coal tar), light oils, alk. exts.; Alkaline extract (The aqueous extract from carbolic oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.) 648-112-00-4 292-610-0 90640-88-3 J, M

558. L 396/558 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Extracts, coal tar oil alk.; Alkaline extract (The extract from coal tar oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.) 648-113-00-X 266-017-2 65996-83-0 J, M Distillates (coal tar), naphthalene oils, alk. exts.; Alkaline extract (The aqueous extract from naphthalene oil produced by an alkaline wash such as aqueous sodium hydroxid. Composed primarily of the alkali salts of various phenolic compounds.) 648-114-00-5 292-611-6 90640-89-4 J, M Extract residues (coal), tar oil alk., carbonated, limed; Crude phenols (The product obtained by treatment of coal tar oil alkaline extract with CO 2 and CaO. Composed primarily of CaCO 3 , Ca(OH) 2 , Na 2 CO 3 and other organic and inorganic impurities.) 648-115-00-0 292-629-4 90641-06-8 J, M

559. 30.12.2006 EN Official Journal of the European Union L 396/559 Substances Index number EC number CAS number Notes Tar acids, brown-coal, crude; Crude phenols (An acidified alkaline extract of brown coal tar distillate. Composed primarily of phenol and phenol homologs.) 648-117-00-1 309-888-7 101316-86-3 J, M Tar acids, brown-coal gasification; Crude phenols (A complex combination of organic compounds obtained from brown coal gasification. Composed primarily of C 6-10 hydroxy aromatic phenols and their homologs.) 648-118-00-7 295-536-7 92062-22-1 J, M Tar acids, distillation residues; Distillate phenols (A residue from the distillation of crude phenol from coal. It consists predominantly of phenols having carbon numbers in the range of C 8 through C 10 with a softening point of 60°C to 80°C.) 648-119-00-2 306-251-5 96690-55-0 J, M Tar acids, methylphenol fraction; Distillate phenols (The fraction of tar acid rich in 3- and 4-methylphenol, recovered by distillation of low-temperature coal tar crude tar acids.) 648-120-00-8 284-892-9 84989-04-8 J, M

560. L 396/560 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Tar acids, polyalkylphenol fraction; Distillate phenols (The fraction of tar acids, recovered by distillation of low-temperature coal tar crude tar acids, having an approximate boiling range of 225°C to 320°C. Composed primarily of polyalkylphenols.) 648-121-00-3 284-893-4 84989-05-9 J, M Tar acids, xylenol fraction; Distillate phenols (The fraction of tar acids, rich in 2,4- and 2,5-dimethylphenol, recovered by distillation of low-temperature coal tar crude tar acids.) 648-122-00-9 284-895-5 84989-06-0 J, M Tar acids, ethylphenol fraction; Distillate phenols 648-123-00-4 284-891-3 84989-03-7 J, M (The fraction of tar acids, rich in 3- and 4-ethylphenol, recovered by distillation of low-temperature coal tar crude tar acids.)

561. 30.12.2006 EN Official Journal of the European Union L 396/561 Substances Index number EC number CAS number Notes Tar acids, 3,5-xylenol fraction; Distillate phenols (The fraction of tar acids, rich in 3,5-dimethylphenol, recovered by distillation of low-temperature coal tar acids.) 648-124-00-X 284-896-0 84989-07-1 J, M Tar acids, residues, distillates, first-cut; Distillate phenols (The residue from the distillation in the range of 235°C to 355°C of light carbolic oil.) 648-125-00-5 270-713-1 68477-23-6 J, M Tar acids, cresylic, residues; Distillate phenols (The residue from crude coal tar acids after removal of phenol, cresols, xylenols and any higher boiling phenols. A black solid with a melting point approximately 80°C. Composed primarily of polyalkyphenols, resin gums, and inorganic salts.) 648-126-00-0 271-418-0 68555-24-8 J, M Phenols, C 9-11 ; Distillate phenols 648-127- 00-6 293-435-2 91079-47-9 J, M

562. L 396/562 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Tar acids, cresylic; Distillate phenols (A complex combination of organic compounds obtained from brown coal and boiling in the range of approximately 200°C to 230°C. It contains chiefly phenols and pyridine bases.) 648-128-00-1 295-540-9 92062-26-5 J, M Tar acids, brown-coal, C 2 -alkylphenol fraction; Distillate phenols (The distillate from the acidification of alkaline washed lignite tar distillate boiling in the range of approximately 200°C to 230°C. Composed primarily of m- and p-ethylphenol as well as cresols and xylenols.) 648-129-00-7 302-662-9 94114-29-1 J, M Extract oils (coal) , naphthalene oils; Acid extract (The aqueous extract produced by an acidic wash of alkali-washed naphthalene oil. Composed primarily of acid salts of various aromatic nitrogen bases including pyridine, quinoline and their al kyl derivatives.) 648-130-00-2 292-623-1 90641-00-2 J, M Tar bases, quinoline derivs.; Distillate bases 648-131-00-8 271-020-7 68513-87-1 J, M Tar bases, coal, quinoline derivs. fraction; Distillate bases 648-132-00-3 274-560-1 70321-67-4 J, M

563. 30.12.2006 EN Official Journal of the European Union L 396/563 Substances Index number EC number CAS number Notes Tar bases, coal, distillation residues; Distillate bases 648- 133 -00-9 274-544-0 92062-29-8 J, M (The distillation residue remaining after the distillation of the neutralised, acid-extracted base-containing tar fractions obtained by the distillation of coal tars. It contains chiefly aniline, collidines, quinoline and quinoline derivatives and toluidines.) Hydrocarbon oils, ar om., mixed with polyethylene and polypropylene, pyrolysed, light oil fraction; Heat treatment products (The oil obtained from the heat treatment of a polyethylene/polypropylene mixture with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of approximately 70°C to 120°C.) 648-134-00-4 309-745-9 100801-63-6 J, M Hydrocarbon oils, ar om., mixed with polyethylene, pyrolysed, light oil fraction; Heat treatment products (The oil obtained from the heat treatment of polyethylene with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of 70°C to 120°C.) 648-135-00-X 309-748-5 100801-65-8 J, M

564. L 396/564 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Hydrocarbon oils, ar om., mixed with polystyrene, pyrolysed, light oil fraction; Heat treatment products 648-136-00-5 309-749-0 100801-66-9 J, M (The oil obtained from the heat treatment of polystyrene with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of approximately 70°C to 210°C.) Extract residues (coal), tar oil alk., naphthalene distil lation residues; Naphthalene oil extract residue (The residue obtained from chemical oil extracted after the removal of naphthalene by distillation composed primarily of two to four membered condensed ring aromatic hydrocarbons and aromatic nitrogen bases.) 648-137-00-0 277-567-8 736665-18-6 J, M Creosote oil, low-boiling distillate; Wash oil (The low-boiling distillation fraction obtained from the high temperature carbonisation of bituminous coal, which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillate, removed. It is crystal free at approximately 38°C.) 648-138-00-6 274-566-4 70321-80-1 H

565. 30.12.2006 EN Official Journal of the European Union L 396/565 Substances Index number EC number CAS number Notes Tar acids, cresylic, sodium salts, caustic solns.; Alkaline extract 648-139-00-1 272-361-4 68815-21-4 J, M Extract oils (coal), tar base; Acid extract 648-140-00-7 266-020-9 65996-86-3 J, M (The extract from co al tar oil alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove naphthalene. Composed primarily of the acid salts of various aromatic nitrogen bases including pyridine, quinoline, and their alkyl derivatives.) Tar bases, coal, crude; Crude tar bases (The reaction product obtained by neutralising coal ta r base extract oil with an alkaline solution, such as aqueous sodium hydroxide, to obtain the free bases. Composed primarily of such organic bases as acridine, phenanthridine, pyridine, quinoline and their alkyl derivatives.) 648-141-00-2 266-018-8 65996-84-1 J, M Residues (coal), liq. solvent extn.; (A cohesive powder composed of coal mineral matter and undissolved coal remaining after extraction of coal by a liquid solvent.) 648-142-00-8 302-681-2 94114-46-2 M

566. L 396/566 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Coal liquids, liq. solvent extn. soln.; (The product obtained by filtration of coal mineral matter and undissolved coal from coal extract solution produced by digesting coal in a liquid solvent. A black, viscous, highly complex liquid combination composed primarily of aromatic and partly hydrogenated aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic and other aromatic oxygen compounds and their alkyl derivatives.) 648-143-00-3 302-682-8 94114-47-3 M Coal liquids, liq. solvent extn.; (The substantially solvent-free product obtained by the distillation of the solvent from filtered coal extract solution produced by digesting coal in a liquid solvent. A black semi-solid, composed primarily of a complex combination of condensed-ring aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic compounds and other aromatic oxygen compounds, and their alkyl derivatives.) 648-144-00-9 302-683-3 94114-48-4 M

567. 30.12.2006 EN Official Journal of the European Union L 396/567 Substances Index number EC number CAS number Notes Light oil (coal), coke-oven; Crude benzole (The volatile organic liquid extracted from the gas evolved in the high temperature (greater than 700°C) destructive distillation of coal. Composed primarily of benzene, toluene, and xylenes. May contain other minor hydrocarbon constituents.) 648-147-00-5 266-012-5 65996-78-3 J Distillates (coal), liq. solvent extn., primary; (The liquid product of condensation of vapours emitted during the digestion of coal in a liquid solvent and boiling in the range of approximately 30°C to 300°C. Composed primarily of partly hydrogenated condensed-ring aromatic hydrocarbons, aromatic compounds containing nitrogen, oxygen and sulfur, and their alkyl derivatives having carbon numbers predominantly in the range of C 4 through C 14 .) 648-148-00-0 302-688-0 94114-52-0 J

568. L 396/568 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (coal), solvent extn., hydrocracked; (Distillate obtained by hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction process and boiling in the range of approximately 30°C to 300°C. Composed primarily of aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes with carbon numbers predominantly in the range of C 4 through C 14 . Nitrogen, sulfur and oxygen-containing aromatic and hydrogenated aromatic compounds are also present.) 648-149-00-6 302-689-6 94114-53-1 J

569. 30.12.2006 EN Official Journal of the European Union L 396/569 Substances Index number EC number CAS number Notes Naphtha (coal), solvent extn., hydrocracked; (Fraction of the dist illate obtained by hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 30°C to 180°C. Composed primarily of aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes with carbon numbers predominantly in the range of C 4 to C 9 . Nitrogen, sulfur and oxygen-containing aromatic and hydrogenated aromatic compounds are also present.) 648-150-00-1 302-690-1 94114-54-2 J Gasoline, coal solvent extn., hydrocracked naphtha; (Motor fuel produced by the reforming of the refined naphtha fraction of the products of hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 30°C to 180°C. Composed primarily of aromatic and naphthenic hydrocarbons, their alkyl derivatives and alkyl hydrocarbons having carbon numbers in the range of C 4 through C 9 .) 648-151-00-7 302-691-7 94114-55-3 J

570. L 396/570 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (coal), solvent extn., hydrocracked middle; (Distillate obtained from the hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 180°C to 300°C. Composed primarily of two-ring aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes having carbon numbers predominantly in the range of C 9 through C 14 . Nitrogen, sulfur and oxygen-containing compounds are also present.) 648-152-00-2 302-692-2 94114-56-4 J

571. 30.12.2006 EN Official Journal of the European Union L 396/571 Substances Index number EC number CAS number Notes Distillates (coal), solvent extn., hydrocracked hydrogenated middle; (Distillate from the hydrogenation of hydrocracked middle distillate from coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 180°C to 280°C. Composed primarily of hydrogenated two-ring carbon compounds and their alkyl derivatives having carbon numbers predominantly in the range of C 9 through C 14 .) 648-153-00-8 302-693-8 94114-57-5 J Light oil (coal), semi-coking process; Fresh oil (The volatile organic liquid condensed from the gas evolved in the low temperature (less than 700°C) destructive distillation of coal. Composed primarily of C 6-10 hydrocarbons.) 648-156-00-4 292-635-7 90641-11-5 J Extracts (petroleum), light naphthenic distillate solvent 649-001-00-3 265-102-1 64742-03-6 H Extracts (petroleum), heavy paraffinic distillate solvent 649-002-00-9 265-103-7 64742-04-7 H Extracts (petroleum), light paraffinic distillate solvent 649-003-00-4 265-104-2 6472-05-8 H

572. L 396/572 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Extracts (petroleum), heavy naphthenic distillate solvent 649-004-00-X 265-111-0 64742-11-6 H Extracts (petroleum), light vacuum gas oil solvent 649-005-00-5 295-341-7 91995-78-7 H Hydrocarbons C 26-55 , arom.-rich 649-006-00-0 307-753-7 97722-04-8 H Residues (petroleum), atm. tower; Heavy fuel oil (A complex residuum from the atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C 20 and boiling above approximately 350°C. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.) 649-008-00-1 265-045-2 64741-45-3 Gas oils (petroleum), heavy vacuum; Heavy fuel oil (A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 and boiling in the range of approximately 350°C to 600°C. This stream is likely to contain 5 wt. % more of 4- to 6-membered condensed ring aromatic hydrocarbons.) 649-009-00-7 265-058-3 64741-57-7

573. 30.12.2006 EN Official Journal of the European Union L 396/573 Substances Index number EC number CAS number Notes Distillates (petroleum), heavy catalytic cracked; Heavy fuel oil 649-010-00-2 265-063-0 64741-61-3 (A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 35 and boiling in the range of approximately 260°C to 500°C. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.) Clarified oils (petroleum), catalytic cracked; Heavy fuel oil (A complex combination of hydrocarbons produced as the residual fraction from distillation of the products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C 20 and boiling above approximately 350°C. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.) 649-011-00-8 265-064-6 64741-62-4 Residues (petroleum ), hydrocracked; Heavy fuel oil (A complex combination of hydrocarbons produced as the residual fraction from distillation of the products of a hydrocracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C 20 and boiling above approximately 350°C.) 649-012-00-3 265-076-1 64741-75-9

574. L 396/574 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Residues (petroleum), thermal cracked; Heavy fuel oil (A complex combination of hydrocarbons produced as the residual fraction from distillation of the product from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly greater than C 20 and boiling above approximately 350°C. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.) 649-013-00-9 265-081-9 64741-80-6 Distillates (petroleum), heavy thermal cracked; Heavy fuel oil (A complex combination of hydrocarbons from th e distillation of the products from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C 15 through C 36 and boiling in the range of approximately 260°C to 480°C. This stream is likely to contain 5 wt. % or more or 4- to 6-membered condensed ring aromatic hydrocarbons.) 649-014-00-4 265-082-4 64741-81-7 Gas oils (petroleum), hydrotreated vacuum; Heavy fuel oil 649-015-00-X 265-162-9 64742-59-2

575. 30.12.2006 EN Official Journal of the European Union L 396/575 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C 13 through C 50 and boiling in the range of approximately 230°C to 600°C. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.) Residues (petroleum) hydrodesulphurised atmospheric tower; Heavy fuel oil (A complex combination of hydrocarbons obtained by treating an atmospheric tower residuum with hydrogen in the presence of a catalyst under conditions primarily to remove organic sulfur compounds. It consists of hydrocarbons having carbon numbers predominantly greater than C 20 and boiling above approximately 350°C. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.) 649-016-00-5 265-181-2 64742-78-5 Gas oils (petroleum), hydrodesulphurised heavy vacuum; Heavy fuel oil 649-017-00-0 265-189-6 64742-86-5

576. L 396/576 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained from a catalytic hydrodesulphurisation process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 and boiling in the range of approximately 350°C to 600°C. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.) Residues (petroleum), steam-cracked; Heavy fuel oil (A complex combination of hydrocarbons obtained as the residual fraction from the distillation of the products of a steam cracking process (including steam cracking to produce ethylene). It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly greater than C 14 and boiling above approximately 260°C. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.) 649-018-00-6 265-193-8 64742-90-1 Residues (petroleum), atmospheric; Heavy fuel oil 649-019-00-1 269-777-3 68333-22-2

577. 30.12.2006 EN Official Journal of the European Union L 396/577 Substances Index number EC number CAS number Notes (A complex residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C 11 and boiling above approximately 200°C. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.) Clarified oils (petroleum), hydrodesulphurised catalytic cracked; Heavy fuel oil (A complex combination of hydrocarbons obtained by treating catalytic cracked clarified oil with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly greater than C 20 and boiling above approximately 350°C. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.) 649-020-00-7 269-782-0 68333-26-6 Distillates (petroleum), hydrodesulphurised intermediate catalytic cracked; Heavy fuel oil 649-021-00-2 269-783-6 68333-27-7

578. L 396/578 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by treating intermediate catalytic cracked distillates with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly in the range of C 11 through C 30 and boiling in the range of approximately 205°C to 450°C. It contains a relative ly large proportion of tricyclic aromatic hydrocarbons.) Distillates (petroleum), hydrodesulphurised heavy catalytic cracked; Heavy fuel oil (A complex combination of hydrocarbons obtained by treatment of heavy catalytic cracked distillates with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 35 and boiling in the range of approximately 260°C to 500°C. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.) 649-022-00-8 269-784-1 68333-28-8 Fuel oil, residues-straight-run gas oils, high-sulfur; Heavy fuel oil 649-023-00-3 270-674-0 68476-32-4

579. 30.12.2006 EN Official Journal of the European Union L 396/579 Substances Index number EC number CAS number Notes Fuel oil, residual; Heavy fuel oil (The liquid product from various refinery streams, usually residues. The composition is complex and varies with the source of the crude oil.) 649-024-00-9 270-675-6 68476-33-5 Residues (petroleum), catalytic reformer fractionator residue distillation; Heavy fuel oil (A complex residuum from the distillation of catalytic reformer fractionator residue. It boils above approximately 399°C.) 649-025-00-4 270-792-2 68478-13-7 Residues (petroleum), heavy coker gas oil and vacuum gas oil; Heavy fuel oil (A complex combination of hydrocarbons produced as the residual fraction from the distillation of heavy coker gas oil and vacuum gas oil. It predominantly consists of hydrocarbons having carbon numbers predominantly greater than C 13 and boiling above approximately 230°C.) 649-026-00-X 270-796-4 68478-17-1 Residues (petroleum), heavy coker and light vacuum; Heavy fuel oil 649-027-00-5 270-983-0 68512-61-8

580. L 396/580 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons produced as the residual fraction from the distillation of heavy coker gas oil and light vacuum gas oil. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C 13 and boiling above approximately 230°C.) Residues (petroleum), light vacuum; Heavy fuel oil (A complex residuum from the vacuum distillation of the residuum from the atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C 13 and boiling above approximately 230°C.) 649-028-00-0 270-984-6 68512-62-9 Residues (petroleum), steam-cracked light; Heavy fuel oil (A complex residuum from the distillation of the products from a steam-cracking process. It consists predominantly of aromatic and unsaturated hydrocarbons having carbon numbers greater than C 7 and boiling in the range of approximately 101°C to 555°C.) 649-029-00-6 271-013-9 68513-69-9 Fuel oil, No 6; Heavy fuel oil (A distillate oil having a minimum viscosity of 197 10 -6 m 2 s -1 at 37,7°C to a maximum of 197 10 -5 m 2 s -1 at 37,7°C.) 649-030-00-1 271-384-7 68553-00-4

581. 30.12.2006 EN Official Journal of the European Union L 396/581 Substances Index number EC number CAS number Notes Residues (petroleum), topping plant, low-sulfur; Heavy fuel oil (A low-sulfur complex combination of hydrocarbons produced as the residual fraction from the topping plant distillation of cr ude oil. It is the residuum after the straight-run gasoline cut, kerose ne cut and gas oil cut have been removed.) 649-031-00-7 271-763-7 68607-30-7 Gas oils (petroleum), heavy atmospheric; Heavy fuel oil (A complex combination of hydrocarbons obtained by the distillation of crude o il. It consists of hydrocarbons having carbon numbers predominantly in the range of C 7 through C 35 and boiling in the range of approximately 121°C to 510°C.) 649-032-00-2 272-184-2 68783-08-4 Residues (petroleum), coker scrubber, Condensed-ring-arom.-contg.; Heavy fuel oil (A very complex combination of hydrocarbons produced as the residual fraction from the distillation of vacuum residuum and the products from a thermal cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C 20 and boiling above approximately 350°C. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.) 649-033-00-8 272-187-9 68783-13-1

582. L 396/582 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (petroleum), petroleum residues vacuum; Heavy fuel oil (A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from the atmospheric distillation of crude oil.) 649-034-00-3 273-263-4 68955-27-1 Residues (petroleum), steam-cracked, resinous; Heavy fuel oil (A complex residuum from the distillation of steam-cracked petroleum residues.) 649-035-00-9 273-272-3 68955-36-2 Distillates (petroleum), intermediate vacuum; Heavy fuel oil (A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C 14 through C 42 and boiling in the range of approximately 250°C to 545°C. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.) 649-036-00-4 274-683-0 70592-76-6 Distillates (petroleum), light vacuum; Heavy fuel oil 649-037-00-X 247-684-6 70592-77-7

583. 30.12.2006 EN Official Journal of the European Union L 396/583 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C 11 through C 35 and boiling in the range of approximately 250°C to 545°C.) Distillates (petroleum), vacuum; Heavy fuel oil (A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having numbers predominantly in the range of C 15 through C 50 and boiling in the range of approximately 270°C to 600°C. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.) 649-038-00-5 274-685-1 70592-78-8 Gas oils (petroleum), hydrodesulphurised coker heavy vacuum; Heavy fuel oil 649-039-00-0 285-555-9 85117-03-9

584. L 396/584 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by hydrodesulphurisation of heavy coker distillate stocks. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range C 18 to C 44 and boiling in the range of approximately 304°C to 548°C. Likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.) Residues (petroleum), steam-cracked, distillates; Heavy fuel oil (A complex combination of hydrocarbons obtained during the production of refined petroleum tar by the distillation of steam cracked tar. It consists predominantly of aromatic and other hydrocarbons and organic sulfur compounds.) 649-040-00-6 292-657-7 90669-75-3 Residues (petroleum), vacuum, light; Heavy fuel oil (A complex residuum from the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C 24 and boiling above approximately 390°C.) 649-041-00-1 292-658-2 90669-76-4

585. 30.12.2006 EN Official Journal of the European Union L 396/585 Substances Index number EC number CAS number Notes Fuel oil, heavy, high-sulphur; Heavy fuel oil (A complex combination of hydrocarbons obtained by the distillation of crude petroleum. It consists predominantly of aliphatic, aromatic and cycloaliphatic hydrocarbons having carbon numbers predominantly higher than C 25 and boiling above approximately 400°C.) 649-042-00-7 295-396-7 92045-14-2 Residues (petroleum), catalytic cracking; Heavy fuel oil (A complex combination of hydrocarbons produced as the residual fraction from the distillation of the products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C 11 and boiling above approximately 200°C.) 649-043-00-2 295-511-0 92061-97-7 Distillates (petroleum), intermediate catalytic cracked, thermally degraded; Heavy fuel oil 649-044-00-8 295-990-6 92201-59-7

586. L 396/586 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process which has been used as a heat transfer fluid. It consists predominantly of hydrocarbons boiling in the range of approximately 220°C to 450°C. This stream is likely to contain organic sulfur compounds.) Residual oils (petroleum); Heavy fuel oil (A complex combination of hydrocarbons, sulfur compounds and metal-containing organic compounds obtained as the residue from refinery fractionation cracking processes. It produces a finished oil with a viscosity above 2 10 -6 m².s -1 at 100°C.) 649-045-00-3 298-754-0 93821-66-0 Residues, steam cracked, thermally treated; Heavy fuel oil (A complex combination of hydrocarbons obtained by the treatment and distillation of raw steam-cracked naphtha. It consists predominantly of unsaturated hydrocarbons boiling in the range above approximately 180°C.) 649-046-00-9 308-733-0 98219-64-8

587. 30.12.2006 EN Official Journal of the European Union L 396/587 Substances Index number EC number CAS number Notes Distillates (petroleum), hydrodesulphurised full-range middle; Heavy fuel oil 649-047-00-4 309-863-0 101316-57-8 (A complex combination of hydrocarbons obtained by treating a petroleum stock with hydrogen. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 9 through C 25 and boiling in the range of approximately 150°C to 400°C.) Residues (petroleum), catalytic reformer fractionator; Heavy fuel oil (A complex combination of hydrocarbons produced as the residual fraction from distillation of the product from a catalytic reforming process. It consists of predominantly aromatic hydrocarbons having carbon numbers predominantly in the range of C 10 through C 25 and boiling in the range of approximately 160°C to 400°C. This stream is likely to contain 5 wt. % or more of 4- or 6-membered condensed ring aromatic hydrocarbons.) 649-048-00-X 265-069-3 64741-67-9

588. L 396/588 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Petroleum; Crude oil (A complex combination of hydrocarbons. It consists predominantly of aliphatic, alicyclic and aromatic hydrocarbons. It may also contain small amounts of nitrogen, oxygen and sulfur compounds. This category encompasses light, medium, and heavy petroleums, as well as the oils extended from tar sands. Hydrocarbonaceous materials requiring major chemical changes for their recovery or conversion to petroleum refinery feedstocks such as crude shale oils; upgraded shale oils and liquid coal fuels are not included in this definition.) 649-049-00-5 232-298-5 8002-05-9 Gases (petroleum), catalytic cracked naphtha depropaniser overhead, C 3- rich acid-free; Petroleum gas (A complex combination of hydrocarbons obtained from fractionation of catalytic cracked hydrocarbons and treated to remove acidic impurities. It consists of hydrocarbons having carbon numbers in the range of C 2 through C 4 , predominantly C 3 .) 649-062-00-6 270-755-0 68477-73-6 K

589. 30.12.2006 EN Official Journal of the European Union L 396/589 Substances Index number EC number CAS number Notes Gases (petroleum), catalytic cracker; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of the products from a catalytic cracking process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-063-00-1 270-756-6 68477-74-7 K Gases (petroleum), catalytic cracker, C 1-5 -rich; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of aliphatic hydrocarbons having carbon numbers in the range of C 1 through C 6 , predominantly C 1 through C 5 .) 649-064-00-7 270-757-1 68477-75-8 K Gases (petroleum), catalytic polymd. naphtha stabiliser overhead, C 2-4 -rich; Petroleum gas (A complex combination of hydrocarbons obtained from the fractionation stabilisation of catalytic polymerised naphtha. It consists of aliphatic hydrocar bons having carbon numbers in the range of C 2 through C 6 , predominantly C 2 through C 4 .) 649-065-00-2 270-758-7 68477-76-9 K

590. L 396/590 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gases (petroleum), catalytic reformer, C 1-4 -rich; Petroleum gas (A complex combination of hydrocarbons produced by distillation of products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers in the range of C 1 through C 6 , predominantly C 1 through C 4 .) 649-066-00-8 270-760-8 68477-79-2 K Gases (petroleum), C 3-5 olefinic-paraffini c alkylation feed; Petroleum gas (A complex combination of olefinic and paraffinic hydrocarbons having carbon numbers in the range of C 3 through C 5 which are used as alkylation feed. Ambient temperatures normally exceed the critical temperature of these combinations.) 649-067-00-3 270-765-5 68477-83-8 K Gases (petroleum), C 4 -rich; Petroleum gas (A complex combination of hydrocarbons produced by distillation of products from a catalytic fractionation process. It consists of aliphatic hydrocar bons having carbon numbers in the range of C 3 through C 5 , predominantly C 4 .) 649-068-00-9 270-767-6 68477-85-0 K

591. 30.12.2006 EN Official Journal of the European Union L 396/591 Substances Index number EC number CAS number Notes Gases (petroleum), deethaniser overheads; Petroleum gas (A complex combination of hydrocarbons produced from distillation of the gas and gasoline fractions from the catalytic cracking process. It contains predominantly ethane and ethylene.) 649-069-00-4 270-768-1 68477-86-1 K Gases (petroleum), deisobutaniser tower overheads; Petroleum gas (A complex combination of hydrocarbons produced by the atmospheric distillation of a butane-butylene stream. It consists of aliphatic hydrocar bons having carbon numbers predominantly in the range of C 3 through C 4 .) 649-070-00-X 270-769-7 68477-87-2 K Gases (petroleum), depropaniser dry, propene-rich; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of products from the gas and gasoline fractions of a catalytic cracking process. It consists predominantly of propylene with some ethane and propane.) 649-071-00-5 270-772-3 68477-90-7 K Gases (petroleum), depropaniser overheads; Petroleum gas 649-072-00-0 270-773-9 68477-91-8 K

592. L 396/592 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons produced by distillation of products from the gas and gasoline fractions of a catalytic cracking process. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C 2 through C 4 .) Gases (petroleum), gas recovery plant depropaniser overheads; Petroleum gas (A complex combination of hydrocarbons obtained by fractionation of miscellaneous hydrocarbon streams. It consists predominantly of hydrocarbons having carbon numbers in the range of C 1 through C 4 , predominantly propane.) 649-073-00-6 270-777-0 68477-94-1 K Gases (petroleum), Girbatol unit feed; Petroleum gas (A complex combination of hydrocarbons that is used as the feed into the Girbatol unit to remove hydrogen sulfide. It consists of aliphatic hydrocar bons having carbon numbers predominantly in the range of C 2 through C 4 .) 649-074-00-1 270-778-6 68477-95-2 K

593. 30.12.2006 EN Official Journal of the European Union L 396/593 Substances Index number EC number CAS number Notes Gases (petroleum), isomerised naphtha fractionator, C 4 -rich, hydrogen sulfide-free; Petroleum gas 649-075-00-7 270-782-8 68477-99-6 K Tail gas (petroleum), catalytic cracked clarified oil and thermal cracked vacuum residue fractionation reflux drum; Petroleum gas 649-076-00-2 270-802-5 68478-21-7 K (A complex combination of hydrocarbons obtained from fractionation of catalytic cracked clarified oil and thermal cracked vacuum residue. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) Tail gas (petroleum), catalytic cracked naphtha stabilisation absorber; Petroleum gas (A complex combination of hydrocarbons obtained from the stabilisation of catalytic cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-077-00-8 270-803-0 68478-22-8 K

594. L 396/594 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Tail gas (petroleum), catalytic cracker, catalytic reformer and hydrodesulphuriser combined fractionater; Petroleum gas (A complex combination of hydrocarbons obtained from the fractionation of products from catalytic cracking, catalytic reforming and hydrodesulphurising processes treated to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-078-00-3 270-804-6 68478-24-0 K Tail gas (petroleum), catalytic reformed naphtha fractionation stabiliser; Petroleum gas (A complex combination of hydrocarbons obtained from the fractionation stabilisation of catalytic reformed naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-079-00-9 270-806-7 68478-26-2 K

595. 30.12.2006 EN Official Journal of the European Union L 396/595 Substances Index number EC number CAS number Notes Tail gas (petroleum), saturate gas plant mixed stream, C 4 -rich; Petroleum gas (A complex combination of hydrocarbons obtained from the fractionation stabilisation of straight-run naphtha , distillation tail gas and catalytic reformed naphtha stabiliser tail gas. It consists of hydrocarbons having carbon numbers in the range of C 3 through C 6 , predominantly butan e and isobutane.) 649-080-00-4 270-813-5 68478-32-0 K Tail gas (petroleum), saturate gas recovery plant, C 1-2 -rich; Petroleum gas (A complex combination of hydrocarbons obtained from fractionation of distillate tail gas, straight-run naphtha, catalytic reformed naphtha stabiliser tail gas. It consists predominantly of hydrocarbons having carbon numbers in the range of C 1 through C 5 , predominantly methane and ethane.) 649-081-00-X 270-814-0 68478-33-1 K

596. L 396/596 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Tail gas (petroleum), vacuum residues thermal cracker; Petroleum gas (A complex combination of hydrocarbons obtained from the thermal cracking of vacuum residues. It consists of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-082-00-5 270-815-6 68478-34-2 K Hydrocarbons, C 3-4 -rich, petroleum distillate; Petroleum gas (A complex combination of hydrocarbons produced by distillation and condensation of crude oil. It consists of hydrocarbons having carbon numbers in the range of C 3 through C 5 , predominantly C 3 through C 4 .) 649-083-00-0 270-990-9 68512-91-4 K Gases (petroleum), full-range straight-run naphtha dehexaniser off; Petroleum gas (A complex combination of hydrocarbons obtained by the fractionation of the full-range straight-run naphtha. It consists of hydrocarbons having carbon numbers predominantly in the range of C 2 through C 6 .) 649-084-00-6 271-000-8 68513-15-5 K Gases (petroleum), hydrocracking depropaniser off, hydrocarbon-rich; Petroleum gas 649-085-00-1 271-001-3 68513-16-6 K

597. 30.12.2006 EN Official Journal of the European Union L 396/597 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbon produced by the distillation of products from a hydrocracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 . It may also contain small amounts of hydrogen and hydrogen sulfide.) Gases (petroleum), light straight-run naphtha stabiliser off; Petroleum gas (A complex combination of hydrocarbons obtained by the stabilisation of light straight-run naphtha. It consists of saturated aliphatic hydrocar bons having carbon numbers predominantly in the range of C 2 through C 6 .) 649-086-00-7 271-002-9 68513-17-7 K Residues (petroleum), alkylation splitter, C 4 -rich; Petroleum gas (A complex residuum from the distillation of streams from various refinery operations. It consists of hydrocarbons having carbon numbers in the range of C 4 through C 5 , predominantly butane, and boiling in the range of approximately -11,7°C to 27,8°C.) 649-087-00-2 271-010-2 68513-66-6 K Hydrocarbons, C 1-4 , sweetened; Petroleum gas 649-089-00-3 271-038-5 68514-36-3 K

598. L 396/598 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by subjecting hydrocarbon gases to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 and boiling in the range of approximately -164°C to -0,5°C.) Hydrocarbons, C 1-3 ; Petroleum gas (A complex combination of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 3 and boiling in the range of approximately -164°C to -42°C.) 649-090-00-9 271-259-7 68527-16-2 K Hydrocarbons, C 1-4 , debutaniser fraction; Petroleum gas 649-091-00-4 271-261-8 68527-19-5 K Gases (petroleum), C 1-5 , wet; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of crude oil and/or the cracking of tower gas oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-092-00-X 271-624-0 68602-83-5 K Hydrocarbons, C 2-4 ; Petroleum gas 649-093-00-5 271-734-9 68606-25-7 K Hydrocarbons, C 3 ; Petroleum gas 649-094-00-0 271-735-4 68606-26-8 K

599. 30.12.2006 EN Official Journal of the European Union L 396/599 Substances Index number EC number CAS number Notes Gases (petroleum), alkylation feed; Petroleum gas (A complex combination of hydrocarbons produced by the catalytic cracking of gas oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C 3 through C 4 .) 649-095-00-6 271-737-5 68606-27-9 K Gases (petroleum), depropaniser bottoms fractionation off; Petroleum gas (A complex combination of hydrocarbons obtained from the fractionation of depropaniser bottoms. It consists predominantly of butane, isobutane and butadiene.) 649-096-00-1 271-742-2 68606-34-8 K Gases (petroleum), refinery blend; Petroleum gas (A complex combination obtained from various processes. It consists of hydrogen, hydrogen sulfide and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-097-00-7 272-183-7 68783-07-3 K Gases (petroleum), catalytic cracking; Petroleum gas 649-098-00-2 272-203-4 68783-64-2 K

600. L 396/600 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons produced by the distillation of the products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 3 through C 5 .) Gases (petroleum), C 2-4 , sweetened; Petroleum gas (A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers predominantly in the range of C 2 through C 4 and boiling in the range of approximately -51°C to -34°C.) 649-099-00-8 272-205-5 68783-65-3 K Gases (petroleum), crude oil fractionation off; Petroleum gas (A complex combination of hydrocarbons produced by the fractionation of crude oil. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-100-00-1 272-871-7 68918-99-0 K

601. 30.12.2006 EN Official Journal of the European Union L 396/601 Substances Index number EC number CAS number Notes Gases (petroleum), dehexaniser off; Petroleum gas (A complex combination of hydrocarbons obtained by the fractionation of combined naphtha streams. It consists of saturated aliphatic hydrocar bons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-101-00-7 272-872-2 68919-00-6 K Gases (petroleum), light straight run gasoline fractionation stabiliser off; Petroleum gas (A complex combination of hydrocarbons obtained by the fractionation of light straight-run gasoline. It consists of saturated aliphatic hydrocar bons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-102-00-2 272-878-5 68919-05-1 K Gases (petroleum), naphtha unifiner desulphurisation stripper off; Petroleum gas (A complex combination of hydrocarbons produced by a naphtha unifiner desulphurisation process and stripped from the naphtha product. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-103-00-8 272-879-0 68919-06-2 K

602. L 396/602 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gases (petroleum), straight-run naphtha catalytic reforming off; Petroleum gas (A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha and fractionation of the total effluent. It consists of methane, ethane, and propane.) 649-104-00-3 272-882-7 68919-09-5 K Gases (petroleum), fluidised catalytic cracker splitter overheads; Petroleum gas (A complex combination of hydrocarbons produced by the fractionation of the charge to the C 3- C 4 splitter. It consists predominantly of C 3 hydrocarbons.) 649-105-00-9 272-893-7 68919-20-0 K Gases (petroleum), straight-run stabiliser off; Petroleum gas (A complex combination of hydrocarbons obtained from the fractionation of the liquid from the first tower used in the distillation of crude oil. It consists of saturated aliphatic hydrocar bons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-106-00-4 272-883-2 68919-10-8 K Gases (petroleum), catalytic cracked naphtha debutaniser; Petroleum gas 649-107-00-X 273-169-3 68952-76-1 K

603. 30.12.2006 EN Official Journal of the European Union L 396/603 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained from fractionation of catalytic cracked naphtha. It consists of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) Tail gas (petroleum), catalytic cracked distillate and naphtha stabiliser; Petroleum gas (A complex combination of hydrocarbons obtained by the fractionation of catalytic cracked naphtha and distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-108-00-5 273-170-9 68952-77-2 K Tail gas (petroleum), thermal-cracked distillate, gas oil and naphtha absorber; Petroleum gas (A complex combination of hydrocarbons obtained from the separation of thermal-cracked distillates, naphtha and gas oil. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-109-00-0 273-175-6 68952-81-8 K Tail gas (petroleum), thermal cracked hydrocarbon fractiona tion stabiliser, petroleum coking; Petroleum gas 649-110-00-6 273-176-1 68952-82-9 K

604. L 396/604 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained from the fractionation stabilisation of thermal cracked hydrocarbons from a petroleum coking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) Gases (petroleum, light steam-cracked, butadiene conc.; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists of hydrocarbons having a carbon number predominantly of C 4 .) 649-111-00-1 273-265-5 68955-28-2 K Gases (petroleum), straight-run naphtha catalytic reformer stabiliser overhead; Petroleum gas (A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha and the fractionation of the total effluent. It c onsists of saturated aliphatic hydrocar bons having carbon numbers predominantly in the range of C 2 through C 4 .) 649-112-00-7 273-270-2 68955-34-0 K Hydrocarbons, C 4 ; Petroleum gas 649-113-00-2 289-339-5 87741-01-3 K Alkanes, C 1-4 , C 3 -rich; Petroleum gas 649-114-00-8 292-456-4 90622-55-2 K

605. 30.12.2006 EN Official Journal of the European Union L 396/605 Substances Index number EC number CAS number Notes Gases (petroleum), steam-cracker C 3- rich; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of products from a steam cracking process. It consists predominantly of propylene with some propane and boils in the range of approximately -70°C to 0°C.) 649-115-00-3 295-404-9 92045-22-2 K Hydrocarbons, C 4 , steam-cracker distillate; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of the products of a steam cracking process. It consists predominantly of hydrocarbons having a carbon number of C 4 , predominantly 1-butene and 2-butene, containing also butane and isobutene and boiling in the range of approximately -12°C to 5°C.) 649-116-00-9 295-405-4 92045-23-3 K Petroleum gases, liquefied, sweetened, C 4 fraction; Petroleum gas (A complex combination of hydrocarbons obtained by subjecting a liquified petroleum gas mix to a sweetening process to oxidise mercaptans or to remove acidic impurities. It consists predominantly of C 4 saturated and unsaturated hydrocarbons.) 649-117-00-4 295-463-0 92045-80-2 K

606. L 396/606 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Hydrocarbons, C 4 , 1,3-butadiene-and isobutene-free; Petroleum gas 649-118-00-X 306-004-1 95465-89-7 K Raffinates (petroleum), steam-cracked C 4 fraction cuprous ammonium acetate extn., C 3-5 and C 3-5 unsaturated., butadiene-free; Petroleum gas 649- 119 -00-5 307-769-4 97722-19-5 K Gases (petroleum), amine system feed; Refinery gas (The feed gas to the amine system for removal of hydrogen sulphide. It consists primarily of hydrogen. Carbon monoxide, carbon dioxide, hydrogen sulfide and aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 may also be present.) 649-120-00-0 270-746-1 68477-65-6 K Gases (petroleum), benzene unit hydrodesulphuriser off; Refinery gas (Off gases produced by the benzene unit. It consists primarily of hydrogen. Carbon monoxide and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 , including benzene, may also be present.) 649-121-00-6 270-747-7 68477-66-7 K Gases (petroleum), benzene unit recycle, hydrogen-ri ch; Refinery gas 649-122-00-1 270-748-2 68477-67-8 K

607. 30.12.2006 EN Official Journal of the European Union L 396/607 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by recycling the gases of the benzene unit. It consists primarily of hydrogen with various small amounts of carbon monoxide and hydrocarbons having carbon numbers in the range of C 1 through C 6 .) Gases (petroleum), blend oil, hydrogen-nitrogen-rich; Refinery gas (A complex combination of hydrocarbons obtained by distillation of a blend oil. It c onsists primarily of hydrogen and nitrogen with various small amounts of carbon monoxide, carbon dioxide, and aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-123-00-7 270-749-8 68477-68-9 K Gases (petroleum), catalytic reformed naphtha stripper overheads; Refinery gas (A complex combination of hydrocarbons obtained from stabilisation of catalytic reformed naphtha. It consists of hydrogen and saturated hydrocar bons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-124-00-2 270-759-2 68477-77-0 K Gases (petroleum), C 6-8 catalytic reformer recycle; Refinery gas 649-125-00-8 270-761-3 68477-80-5 K

608. L 396/608 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons produced by distillation of products from catalytic reforming of C 6 -C 8 feed and recycled to conserve hydrogen. It consists primarily of hydrogen. It may also contain various small amounts of carbon monoxide, carbon dioxide, nitrogen, and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) Gases (petroleum), C 6-8 catalytic reformer; Refinery gas (A complex combination of hydrocarbons produced by distillation of products from catalytic reforming of C 6 -C 8 feed. It consists of hydrocarbons having carbon numbers in the range of C 1 through C 5 and hydrogen.) 649-126-00-3 270-762-9 68477-81-6 K Gases (petroleum), C 6-8 catalytic reformer recycle, hydrogen-rich; Refinery gas 649-127-00-9 270-763-4 68477-82-7 K Gases (petroleum), C 2 -return stream; Refinery gas 649-128-00-4 270-766-0 68477-84-9 K

609. 30.12.2006 EN Official Journal of the European Union L 396/609 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by the extraction of hydrogen from a gas stream which consists primarily of hydrogen with small amounts of nitrogen, carbon monoxide, methane, ethane, and ethylene. It contains predominantly hydrocarbons such as methane, ethane, and ethylene with small amounts of hydrogen, nitrogen and carbon monoxide.) Gases (petroleum), dry sour, gas-concentration-unit-off; Refinery gas (The complex combination of dry gases from a gas concentration unit. It consists of hydrogen, hydrogen sulphide and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 3 .) 649-129-00-X 270-774-4 68477-92-9 K Gases (petroleum), gas concentration reabsorber distillation; Refinery gas (A complex combination of hydrocarbons produced by distillation of products from combined gas streams in a gas concentration reabsorber. It consists predominantly of hydrogen, carbon monoxide, carbon dioxide, nitrogen, hydrogen sulphide and hydrocarbons having carbon numbers in the range of C 1 through C 3 .) 649-130-00-5 270-776-5 68477-93-0 K

610. L 396/610 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gases (petroleum), hydrogen absorber off; Refinery gas (A complex combination obtained by absorbing hydrogen from a hydrogen rich stream. It consists of hydrogen, carbon monoxide, nitrogen, and methane with small amounts of C 2 hydrocarbons.) 649-131-00-0 270-779-1 68477-96-3 K Gases (petroleum), hydrogen-rich; Refinery gas (A complex combination separated as a gas from hydrocarbon gases by chilling. It consists primarily of hydrogen with various small amounts of carbon monoxide, nitrogen, methane, and C 2 hydrocarbons.) 649-132-00-6 270-780-7 68477-97-4 K Gases (petroleum), hydrotreater blend oil recycle, hydrogen-nitrogen-rich; Refinery gas (A complex combination obtained from recycled hydrotreated blend oil. It consists primarily of hydrogen and nitrogen with various small amounts of carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-133-00-1 270-781-2 68477-98-5 K Gases (petroleum), recycle, hydrogen-rich; Refinery gas 649-134-00-7 270-783-3 68478-00-2 K

611. 30.12.2006 EN Official Journal of the European Union L 396/611 Substances Index number EC number CAS number Notes (A complex combination obtained from recycled reactor gases. It consists primarily of hydrogen with various small amounts of carbon monoxide, carbon dioxide, nitrogen, hydrogen sulphide, and saturated aliphatic hydrocar bons having carbon numbers in the range of C 1 through C 5 .) Gases (petroleum), reformer make-up, hydrogen-rich; Refinery gas (A complex combination obtained from the reformers. It consists primarily of hydrogen with various small amounts of carbon monoxide and aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-135-00-2 270-784-9 68478-01-3 K Gases (petroleum), reforming hydrotreater; Refinery gas (A complex combination obtained from the reforming hydrotreating process. It consists primarily of hydrogen, methane, and ethane with various small amounts of hydrogen sulphide and aliphatic hydrocarbons having carbon numbers predominantly in the range C 3 through C 5 .) 649-136-00-8 270-785-4 68478-02-4 K Gases (petroleum), reforming hydrotreater, hydrogen-methane-rich; Refinery gas 649-137-00-3 270-787-5 68478-03-5 K

612. L 396/612 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination obtained from the reforming hydrotreating process. It consists primarily of hydrogen and methane with various small amounts of carbon monoxide, carbon dioxide, nitrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C 2 through C 5 .) Gases (petroleum), reforming hydrotreater make-up, hydrogen-rich; Refinery gas (A complex combination obtained from the reforming hydrotreating process. It consists primarily of hydrogen with various small amounts of carbon monoxide and aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-138-00-9 270-788-0 68478-04-6 K Gases (petroleum), thermal cracking distillation; Refinery gas (A complex combination produced by distillation of products from a thermal cracking process. It consists of hydrogen, hydrogen sulphide, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-139-00-4 270-789-6 68478-05-7 K

613. 30.12.2006 EN Official Journal of the European Union L 396/613 Substances Index number EC number CAS number Notes Tail gas (petroleum), catalytic cracker refractionation absorber; Refinery gas (A complex combination of hydrocarbons obtained from refractionation of products from a catalytic cracking process. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 3 .) 649-140-00-X 270-805-1 68478-25-1 K Tail gas (petroleum), catalytic reformed naphtha separator; Refinery gas (A complex combination of hydrocarbons obtained from the catalytic reforming of straight-run naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-141-00-5 270-807-2 68478-27-3 K Tail gas (petroleum), catalytic reformed naphtha stabiliser; Refinery gas (A complex combination of hydrocarbons obtained from the stabilisation of catalytic reformed naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-142-00-0 270-808-8 68478-28-4 K Tail gas (petroleum), cracked distillate hydrotreater separator; Refinery gas 649-143-00-6 270-809-3 68478-29-5 K

614. L 396/614 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by treating cracked distillates with hydrogen in the presence of a catalyst. It consists of hydrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) Tail gas (petroleum), hydrodesulphurised straight-run naphtha separator; Refinery gas (A complex combination of hydrocarbons obtained from hydrodesulphurisation of straight-run naphtha. It consists of hydrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-144-00-1 270-810-9 68478-30-8 K Gases (petroleum), catalytic reformed straight-run naphtha stabiliser overheads; Refinery gas (A complex combination of hydrocarbons obtained from the catalytic reforming of straight-run naphtha followed by fractionation of the total effluent. It consists of hydrogen, methane, ethane and propane.) 649-145-00-7 270-999-8 68513-14-4 K Gases (petroleum), reformer effluent high-pressure flash drum off; Refinery gas 649-146-00-2 271-003-4 68513-18-8 K

615. 30.12.2006 EN Official Journal of the European Union L 396/615 Substances Index number EC number CAS number Notes (A complex combination produced by the high-pressure flashing of the effluent from the reforming reactor. It consists primarily of hydrogen with various small amounts of methane, ethane, and propane.) Gases (petroleum), reformer effluent low-pressure flash dr um off; Refinery gas (A complex combination produced by low-pressure flashing of the effluent from the reforming reactor. It consists primarily of hydrogen with various small amounts of methane, ethane, and propane.) 649-147-00-8 271-005-5 68513-19-9 K Gases (petroleum), oil refinery gas distillation off; Refinery gas (A complex combination separated by distillation of a gas stream containing hydrogen, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers in the range of C 1 through C 6 or obtained by cracking ethane and propane. It consists of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 2 , hydrogen, nitrogen, and carbon monoxide.) 649-148-00-3 271-258-1 68527-15-1 K Gases (petroleum), benzene unit hydrotreater depentaniser overheads; Refinery gas 649-149-00-9 271-623-5 68602-82-4 K

616. L 396/616 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination produced by treating the feed from the benzene unit with hydrogen in the presence of a catalyst followed by depentanising. It consists primarily of hydrogen, ethane and propane with various small amounts of nitrogen, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 . It may contain trace amounts of benzene.) Gases (petroleum), secondary absorber off, fluidised catalytic cracker overheads fractionator; Refinery gas (A complex combination produced by the fractionation of the overhead products from the catalytic cracking process in the fluidised catalytic cracker. It consists of hydrogen, nitrogen, and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 3 .) 649-150-00-4 271-625-6 68602-84-6 K Petroleum products, refinery gases; Refinery gas (A complex combination which consists primarily of hydrogen with various small amounts of methane, ethane and propane.) 649-151-00-X 271-750-6 68607-11-4 K

617. 30.12.2006 EN Official Journal of the European Union L 396/617 Substances Index number EC number CAS number Notes Gases (petroleum), hydrocracking low-pressure separa tor; Refinery gas (A complex combination obtained by the liquid-vapour separation of the hydrocracking process reactor effluent. It consists predominantly of hydrogen and saturated hydrocarbons having carbon numbers predominantly in the range of C 1 through C 3 .) 649-152-00-5 272-182-1 68783-06-2 K Gases (petroleum), refinery; Refinery gas (A complex combination obtained from various petroleum refining operations. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 3 .) 649-153-00-0 272-338-9 68814-67-5 K Gases (petroleum), platformer products separator off; Refinery gas (A complex combination obtained from the chemical reforming of naphthenes to aromatics. It consists of hydrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C 2 through C 4 .) 649-154-00-6 272-343-6 68814-90-4 K Gases (petroleum), hydrotreated sour kerosine depentaniser stabiliser off; Refinery gas 649-155-00-1 272-775-5 68911-58-0 K

618. L 396/618 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (The complex combination obtained from the depentaniser stabilisation of hydrotreated kerosine. It consists primarily of hydrogen, methane, ethane, and propane with various small amounts of nitrogen, hydrogen sulphide, carbon monoxide and hydrocarbons having carbon numbers predominantly in the range of C 4 through C 5 .) Gases (petroleum), hydrotreated sour kerosine flash drum; Refinery gas (A complex combination obtained from the flash drum of the unit treating sour kerosine with hydrogen in the presence of a catalyst. It consists primarily of hydrogen and methane with various small amounts of nitrogen, carbon monoxide, and hydro-carbons having carbon numbers predominantly in the range of C 2 through C 5 .) 649-156-00-7 272-776-0 68911-59-1 K Gases (petroleum), distillate unifiner desulphurisation stripper off; Refinery gas (A complex combination stripped from the liquid product of the unifiner desulphurisation pro cess. It consists of hydrogen sulphide, methane, ethane, and propane.) 649-157-00-2 272-873-8 68919-01-7 K Gases (petroleum), fluidised catalytic cracker fractionation off; Refinery gas 649-158-00-8 272-874-3 68919-02-8 K

619. 30.12.2006 EN Official Journal of the European Union L 396/619 Substances Index number EC number CAS number Notes (A complex combination produced by the fractionation of the overhead product of the fluidised catalytic cracking process. It consists of hydrogen, hydrogen sulphide, nitrogen, and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) Gases (petroleum), fluidised catalytic cracker scrubbing secondary absorber off; Refinery gas (A complex combination produced by scrubbing the overhead gas from the fluidised catalytic cracker. It consists of hydrogen, nitrogen, methane, ethane and propane.) 649-159-00-3 272-875-9 68919-03-9 K Gases (petroleum), heavy distillate hydrotreater desulphurisation stripper off; Refinery gas (A complex combination stripped from the liquid product of the heavy distillate hydrotreater desulphurisation pro cess. It consists of hydrogen, hydrogen sulphide, and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-160-00-9 272-876-4 68919-04-0 K Gases (petroleum), platformer stabiliser off, light ends fractionation; Refinery gas 649-161-00-4 272-880-6 68919-07-3 K

620. L 396/620 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination obtained by the fractionation of the light ends of the platinum reactors of the platformer unit. It consists of hydrogen, methane, ethane and propane.) Gases (petroleum), preflash tower off, crude distillation; Refinery gas (A complex combination produced from the first tower used in the distillation of crude o il. It consists of nitrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-162-00-X 272-881-1 68919-08-4 K Gases (petroleum), tar stripper off; Refinery gas (A complex combination obtained by the fractionation of reduced crude oil. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-163-00-5 272-884-8 68919-11-9 K Gases (petroleum), unifiner stripper off; Refinery gas (A combination of hydrogen and methane obtained by fractionation of the products from the unifiner unit.) 649-164-00-0 272-885-3 68919-12-0 K Tail gas (petroleum), catalytic hydrodesulphurised naphtha separator; Refinery gas 649-165-00-6 273-173-5 68952-79-4 K

621. 30.12.2006 EN Official Journal of the European Union L 396/621 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained from the hydrodesulphurisation of naphtha. It consists of hydrogen, methane, ethane, and propane.) Tail gas (petroleum), straight-run naphtha hydrodesulphuriser; Refinery gas (A complex combination obtained from the hydrodesulphurisation of straight-run naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-166-00-1 273-174-0 68952-80-7 K Gases (petroleum), sponge absorber off, fluidised catalyt ic cracker and gas oil desulphuriser overhead fractionation; Refinery gas (A complex combination obtained by the fractionation of products from the fluidised catalytic cracker and gas oil desulphuriser. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-167-00-7 273-269-7 68955-33-9 K Gases (petroleum), crude distillation and catalytic cracking; Refinery gas 649-168-00-2 273-563-5 68989-88-8 K

622. L 396/622 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination produced by crude distillation and catalytic cracking processes. It consists of hydrogen, hydrogen sulphide, nitrogen, carbon monoxide and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) Gases (petroleum), gas oil diethanolamine scrubb er off; Refinery gas (A complex combination produced by desulphurisation of gas oils with diethanolamine. It consists predominantly of hydrogen sulphide, hydrogen and aliphatic hydrocarbons having carbon numbers in the range of C 1 through C 5 .) 649-169-00-8 295-397-2 92045-15-3 K Gases (petroleum), gas oil hydrodesulphurisation effluent; Refinery gas (A complex combination obtained by separation of the liquid phase from the effluent from the hydrogenation reaction. It consists predominantly of hydrogen, hydrogen sulphide and aliphatic hydrocar bons having carbon numbers predominantly in the range of C 1 through C 3 .) 649-170-00-3 295-398-8 92045-16-4 K Gases (petroleum), gas oil hydrodesulphurisation purge; Refinery gas 649-171-00-9 295-399-3 92045-17-5 K

623. 30.12.2006 EN Official Journal of the European Union L 396/623 Substances Index number EC number CAS number Notes (A complex combination of gases obtained from the reformer and from the purges from the hydrogenation reactor. It consists predominantly of hydrogen and aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) Gases (petroleum), hydrogenator effluent flash drum off; Refinery gas (A complex combination of gases obtained from flash of the effluents after the hydrogenation reaction. It consists predominantly of hydrogen and aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-172-00-4 295-400-7 92045-18-6 K Gases (petroleum), naphtha steam cracking high-pressure residual; Refinery gas (A complex combination obtained as a mixture of the non-condensable portions from the product of a naphtha steam cracking process as well as residual gases obtained during the preparation of subsequent products. It consists predominantly of hydrogen and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 with which natural gas may also be mixed.) 649-173-00-X 295-401-2 92045-19-7 K

624. L 396/624 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gases (petroleum), residue visbaking off; Refinery gas (A complex combination obtained from viscosity reduction of residues in a furnace. It consists predominantly of hydrogen sulphide and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-174-00-5 295-402-8 92045-20-0 K Foots oil (petroleum), acid-treated; Foots oil (A complex combination of hydrocarbons obtained by treatment of Foot's oil with sulphuric acid. It consists predominantly of branched-chain hydrocarbons with carbon numbers predominantly in the range of C 20 through C 50 .) 649-175-00-0 300-225-7 93924-31-3 L Foots oil (petroleum), clay-treated; Foots oil (A complex combination of hydrocarbons obtained by treatment of Foot's oil with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists predominantly of branched chain hydrocarbons with carbon numbers predominantly in the range of C 20 through C 50 .) 649-176-00-6 300-226-2 93924-32-4 L

625. 30.12.2006 EN Official Journal of the European Union L 396/625 Substances Index number EC number CAS number Notes Gases (petroleum), C 3-4 ; Petroleum gas (A complex combination of hydrocarbons produced by distillation of products from the cracking of crude oil. It consists of hydrocarbons having carbon numbers in the range of C 3 through C 4 , predominantly of propane and propylene, and boiling in the range of approximately -51°C to -1°C.) 649-177-00-1 268-629-5 68131-75-9 K Tail gas (petroleum), catalytic cracked distillate and catalytic cracked naphtha fractionation absorber; Petroleum gas (The complex combination of hydrocarbons from th e distillation of the products from catalytic cracked distillates and catalytic cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C 1 through C 4 .) 649-178-00-7 269-617-2 68307-98-2 K Tail gas (petroleum), catalytic polymerisation naphtha fractionation stabiliser; Petroleum gas (A complex combination of hydrocarbons from the fractionation stabilisation products from polymerisation of naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C 1 through C 4 .) 649-179-00-2 269-618-8 68307-99-3 K

626. L 396/626 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Tail gas (petroleum), catalytic reformed naphtha fractionation stabiliser, hydroge n sulphide-free; Petroleum gas (A complex combination of hydrocarbons obtained from fractionation stabilisation of catalytic reformed naphtha and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-180-00-8 269-619-3 68308-00-9 K Tail gas (petroleum), cracked distillate hydrot reater stripper; Petroleum gas (A complex combination of hydrocarbons obtained by treating thermal cracked distillates with hydrogen in the presence of a catalyst. It consists predominantly of saturated hydrocar bons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-181-00-3 269-620-9 68308-01-0 K Tail gas (petroleum), straight-run distillate hydrodesulphuriser, hydrogen sulphide-free; Petroleum gas 649-182-00-9 269-630-3 68308-10-1 K

627. 30.12.2006 EN Official Journal of the European Union L 396/627 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained from catalytic hydrodesulphurisation of straight run distillates and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) Tail gas (petroleum), gas oil catalytic cracking absorber; Petroleum gas (A complex combination of hydrocarbons obtained from the distillation of products from the catalytic cracking of gas oil. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-183-00-4 269-623-5 68308-03-2 K Tail gas (petroleum), gas recovery plant; Petroleum gas (A complex combination of hydrocarbons from th e distillation of products from miscellaneous hydrocarbon streams. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-184-00-X 269-624-0 68308-04-3 K Tail gas (petroleum), gas recovery plant deethaniser; Petroleum gas 649-185-00-5 269-625-6 68308-05-4 K

628. L 396/628 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons from th e distillation of products from miscellaneous hydrocarbon streams. It consists of hydrocarbon having carbon numbers predominantly in the range of C 1 through C 4 .) Tail gas (petroleum), hydrodesulphurised distillate and hydrodesulphurised naphtha fractionator, acid-free; Petroleum gas (A complex combination of hydrocarbons obtained from fractionation of hydrodesulphurised naphtha and distillate hydrocarbon streams and treated to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-186-00-0 269-626-1 68308-06-5 K Tail gas (petroleum), hydrodesulphurised vacuum gas oil stripper, hydrogen sulphide-free; Petroleum gas (A complex combination of hydrocarbons obtained from stripping stabilisation of catalytic hydrodesulphurised vacuum gas oil and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-187-00-6 269-627-7 68308-07-6 K

629. 30.12.2006 EN Official Journal of the European Union L 396/629 Substances Index number EC number CAS number Notes Tail gas (petroleum), light straight-run naphtha stabiliser, hydrogen sulphide-free; Petroleum gas (A complex combination of hydrocarbons obtained from fractionation stabilisation of light straight-run naphtha and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-188-00-1 269-629-8 68308-09-8 K Tail gas (petroleum), propane-propylene alkylation feed prep deethaniser; Petroleum gas (A complex combination of hydrocarbons obtained from the distillation of the reaction products of propane with propylene. It consists of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-189-00-7 269-631-9 68308-11-2 K

630. L 396/630 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Tail gas (petroleum), vacuum gas oil hydrodesulphuriser, hydrogen sulphide-free; Petroleum gas (A complex combination of hydrocarbons obtained from catalytic hydrodesulphurisation of vacuum gas oil and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-190-00-2 269-632-4 68308-12-3 K Gases (petroleum), catalytic cracked overheads; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of products from the catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 3 through C 5 and boiling in the range of approximately -48°C to 32°C.) 649-191-00-8 270-071-2 68409-99-4 K Alkanes, C 1-2 ; Petroleum gas 649-193-00-9 270-651-5 68475-57-0 K Alkanes, C 2-3 ; Petroleum gas 649-194-00-4 270-652-0 68475-58-1 K Alkanes, C 3-4 ; Petroleum gas 649-195-00-X 270-653-6 68475-59-2 K Alkanes, C 4-5 ; Petroleum gas 649-196-00-5 270-654-1 68475-60-5 K

631. 30.12.2006 EN Official Journal of the European Union L 396/631 Substances Index number EC number CAS number Notes Fuel gases; Petroleum gas (A combination of light gases. It consists predominantly of hydrogen and/or low molecular weight hydrocarbons.) 649-197-00-0 270-667-2 68476-26-6 K Fuel gases, crude oi l of distillates; Petroleum gas (A complex combination of light gases produced by distillation of crude oil and by catalytic reforming of naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 and boiling in the range of approximately -217°C to -12°C.) 649-198-00-6 270-670-9 68476-29-9 K Hydrocarbons, C 3-4 ; Petroleum gas 649-199-00-1 270-681-9 68476-40-4 K Hydrocarbons, C 4-5 ; Petroleum gas 649-200-00-5 270-682-4 68476-42-6 K Hydrocarbons, C 2-4 , C 3 -rich; Petroleum gas 649-201-00-0 270-689-2 68476-49-3 K

632. L 396/632 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Petroleum gases, liquefied; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of crude o il. It consists of hydrocarbons having carbon numbers predominantly in the range of C 3 through C 7 and boiling in the range of approximately -40°C to 80°C.) 649-202-00-6 270-704-2 68476-85-7 K Petroleum gases, liquefied, sweetened; Petroleum gas (A complex combination of hydrocarbons obtained by subjecting liquefied petroleum gas mix to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C 3 through C 7 and boiling in the range of approximately -40°C to 80°C.) 649-203-00-1 270-705-8 68476-86-8 K Gases (petroleum), C 3-4 , isobutane-rich; Petroleum gas 649-204-00-7 270-724-1 68477-33-8 K

633. 30.12.2006 EN Official Journal of the European Union L 396/633 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons from th e distillation of saturated and unsaturated hydrocarbons usually ranging in carbon numbers from C 3 through C 6 , predominantly butane and isobutane. It consists of saturated and unsaturated hydrocarbons having carbon numbers in the range of C 3 through C 4 , predominantly isobutane.) Distillates (petroleum), C 3-6 , piperylene-rich; Petroleum gas (A complex combination of hydrocarbons from th e distillation of saturated and unsaturated aliphatic hydrocarbons usually ranging in the carbon numbers C 3 through C 6 . It consists of saturated and unsaturated hydrocarbons having carbon numbers in the range of C 3 through C 6 , predominantly piperylenes.) 649-205-00-2 270-726-2 68477-35-0 K Gases (petroleum), butane splitter overheads; Petroleum gas (A complex combination of hydrocarbons obtained from the distillation of the butane stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C 3 through C 4 .) 649-206-00-8 270-750-3 68477-69-0 K

634. L 396/634 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gases (petroleum), C 2-3 ; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of products from a catalytic fractionation process. It contains predominantly ethane, ethylene, propane, and propylene.) 649-207-00-3 270-751-9 68477-70-3 K Gases (petroleum), catalytic-cracked gas oil depropaniser bottoms, C 4 -rich acid-free; Petroleum gas (A complex combination of hydrocarbons obtained from fractionation of catalytic cracked gas oil hydrocarbon stream and treated to remove hydrogen sulphide and other acidic components. It consists of hydrocarbons having carbon numbers in the range of C 3 through C 5 , predominantly C 4 .) 649-208-00-9 270-752-4 68477-71-4 K Gases (petroleum), catalytic-cracked naphtha debutaniser bottoms, C 3-5 -rich; Petroleum gas (A complex combination of hydrocarbons obtained from the stabilisation of catalytic cracked naphtha. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C 3 through C 5 .) 649-209-00-4 270-754-5 68477-72-5 K

635. 30.12.2006 EN Official Journal of the European Union L 396/635 Substances Index number EC number CAS number Notes Tail gas (petroleum), isomerised naphtha fractionation stabiliser; Petroleum gas 649-210-00-X 269-628-2 68308-08-7 K (A complex combination of hydrocarbons obtained from the fractionation stabilisation products from isomerised naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) Foots oil (petroleum), carbon-treated; Foot's oil (A complex combination of hydrocarbons obtained by the treatment of Foot's oil with activated carbon for the removal of trace constituents and impurities. It consists predominantly of saturated straight chain hydrocarbons having carbon numbers predominantly greater than C 12 .) 649-211-00-5 308-126-0 97862-76-5 L

636. L 396/636 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (petroleum), sweetened middle; Gas oil – unspecified (A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C 9 through C 20 and boiling in the range of approximately 150°C to 345°C.) 649-212-00-0 265-088-7 64741-86-2 N Gas oils (petroleum), solvent-refined; Gas oil – unspecified 649-213-00-6 265-092-9 64741-90-8 N

637. 30.12.2006 EN Official Journal of the European Union L 396/637 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C 11 through C 25 and boiling in the range of approximately 205°C to 400°C.) Distillates (petroleum), solvent-refined middle; Gas oil – unspecified (A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C 9 through C 20 and boiling in the range of approximately 150°C to 345°C.) 649-214-00-1 265-093-4 64741-91-9 N Gas oils (petroleum), acid-treated; Gas oil – unspecified (A complex combination of hydrocarbons obtained as a raffinate from a sulphuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 13 through C 25 and boiling in the range of approximately 230°C to 400°C.) 649-215-00-7 265-112-6 64742-12-7 N Distillates (petroleum), acid-treated middle; Gas oil – unspecified 649-216-00-2 265-113-1 64742-13-8 N

638. L 396/638 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained as a raffinate from a sulphuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 11 through C 20 and boiling in the range of approximately 205°C to 345°C.) Distillates (petroleum), acid-treated light; Gas oil – unspecified (A complex combination of hydrocarbons obtained as a raffinate from a sulphuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 9 through C 16 and boiling in the range of approximately 150°C to 290°C.) 649-217-00-8 265-114-7 64742-14-9 N Gas oils (petroleum), chemically neutralised; Gas o il – unspecified (A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C 13 through C 25 and boiling in the range of approximately 230°C to 400°C.) 649-218-00-3 265-129-9 64742-29-6 N Distillates (petroleum), chemically neutralised middle; Gas oil – unspecified 649-219-00-9 265-130-4 64742-30-9 N

639. 30.12.2006 EN Official Journal of the European Union L 396/639 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C 11 through C 20 and boiling in the range of approximately 205°C to 345°C.) Distillates (petroleum), clay-treated middle; Gas oil – unspecified (A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay, usually in a percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C 9 through C 20 and boiling in the range of approximately 150°C to 345°C.) 649-220-00-4 265-139-3 64742-38-7 N Distillates (petrole um), hydrotreated middle; Gas oil – unspecified (A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C 11 through C 25 and boiling in the range of approximately 205°C to 400°C.) 649-221-00-X 265-148-2 64742-46-7 N

640. L 396/640 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gas oils (petroleum), hydrodesuphurised; Gas oil – unspecified (A complex combination of hydrocarbons obtained from a petroleum stock by treating with hydrogen to convert organic sulphur to hydrogen sulphide which is removed. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 13 through C 25 and boiling in the range of approximately 230°C to 400°C.) 649-222-00-5 265-182-8 64742-79-6 N Distillates (petroleum), hydrodesulphurised middle; Gas oil – unspecified (A complex combination of hydrocarbons obtained from a petroleum stock by treating with hydrogen to convert organic sulphur to hydrogen sulphide which is removed. It consists of hydrocarbons having carbon numbers predominantly in the range of C 11 through C 25 and boiling in the range of approximately 205°C to 400°C.) 649-223-00-0 265-183-3 64742-80-9 N Distillates (petroleum), catalytic reformer fractionator residue, high-boiling; Gas oil – unspecified (A complex combination of hydrocarbons from th e distillation of catalytic reformer fractionator residue. It boils in the range of approximately 343°C to 399°C.) 649-228-00-8 270-719-4 68477-29-2 N

641. 30.12.2006 EN Official Journal of the European Union L 396/641 Substances Index number EC number CAS number Notes Distillates (petroleum), catalytic reformer fractionator residue, intermediate-boiling; Gas oil – unspecified (A complex combination of hydrocarbons from th e distillation of catalytic reformer fractionator residue. It boils in the range of approximately 288°C to 371°C.) 649-229-00-3 270-721-5 68477-30-5 N Distillates (petroleum), catalytic reformer fractionator residue, low-boiling; Gas oil – unspecified (The complex combination of hydrocarbons from th e distillation of catalytic reformer fractionator residue. It boils approximately below 288°C.) 649-230-00-9 270-722-0 68477-31-6 N Distillates (petroleum), highly refined middle; Gas oil – unspecified (A complex combination of hydrocarbons obtained by the subjection of a petroleum fraction to several of the following steps: filtration, centrifugation, atmospheric distillation, vacuum distillation, acidification, neutralisation and clay treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 10 through C 20 .) 649-231-00-4 292-615-8 90640-93-0 N

642. L 396/642 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (petroleum) catalytic reformer, heavy arom. conc.; Gas oil – unspecified (A complex combination of hydrocarbons obtained from the distillation of a catalytically reformed petroleum cut. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 10 through C 16 and boiling in the range of approximately 200°C to 300°C.) 649-232-00-X 295-294-2 91995-34-5 N Gas oils, paraffinic; Gas oil – unspecified (A distillate obtained from the redistillation of a complex combination of hydrocarbons obtained by the distillation of the effluents from a severe catalytic hydrotreatment of paraffins. It boils in the range of approximately 190°C to 330°C.) 649-233-00-5 300-227-8 93924-33-5 N Naphtha (petroleum), solvent-refined hydrodesulphurised heavy; Gas oil – unspecified 649-234-00-0 307-035-3 97488-96-5 N Hydrocarbons, C 16-20 , hydrotreated middle distillate, distillation lights; Gas oil – unspecified 649-235-00-6 307-659-6 97675-85-9 N

643. 30.12.2006 EN Official Journal of the European Union L 396/643 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the treatment of a middle distillate with hydrogen. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 16 through C 20 and boiling in the range of approximately 290°C to 350°C. It produces a finished oil having a viscosity of 2 10 -6 m².s -1 at 100°C.) Hydrocarbons, C 12-20 , hydrotreated paraffinic, distillati on lights; Gas oil – unspecified (A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the treatment of heavy paraffins with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 12 through C 20 and boiling in the range of approximately 230°C to 350°C. It produces a finished oil having a viscosity of 2 10 -6 m².s -1 at 100°C.) 649-236-00-1 307-660-1 97675-86-0 N Hydrocarbons, C 11-17 , solvent-extd. light naphthenic; Gas oil – unspecified 649-237-00-7 307-757-9 97722-08-2 N

644. L 396/644 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by extraction of the aromatics from a light naphthenic distillate having a viscosity of 2.2 10 -6 m².s -1 at 40°C. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 11 through C 17 and boiling in the range of approximately 200°C to 300°C.) Gas oils, hydrotreated; Gas oil – unspecified (A complex combination of hydrocarbons obtained from the redistillation of the effluents from the treatment of paraffins with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 17 through C 27 and boiling in the range of approximately 330°C to 340°C.) 649-238-00-2 308-128-1 97862-78-7 N Distillates (petroleum), carbon-treated light paraffinic; Ga s oil – unspecified (A complex combination of hydrocarbons obtained by the treatment of a petroleum oil fraction with activated charcoal for the removal of traces of polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 12 through C 28 .) 649-239-00-8 309-667-5 100683-97-4 N

645. 30.12.2006 EN Official Journal of the European Union L 396/645 Substances Index number EC number CAS number Notes Distillates (petroleum), intermediate paraffinic, carbon-treated; Gas oil – unspecified (A complex combination of hydrocarbons obtained by the treatment of petroleum with activated charcoal for the removal of trace polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 16 through C 36 .) 649-240-00-3 309-668-0 100683-98-5 N Distillates (petroleum), intermediate paraffinic, clay-treated; Gas oil – unspecified (A complex combination of hydrocarbons obtained by the treatment of petrol eum with bleaching earth for the removal of trace polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 16 through C 36 .) 649-241-00-9 309-669-6 100683-99-6 N Alkanes, C 12-26 -branched and linear; 649-242-00-4 292-454-3 90622-53-0 N Lubricating greases; Grease (A complex combination of hydrocarbons having carbon numbers predominantly in the range of C 12 through C 50 . May contain organic salts of alkali metals, alkaline earth metals, and/or aluminium compounds.) 649-243-00-X 278-011-7 74869-21-9 N

646. L 396/646 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Slack wax (petroleum); Slack wax (A complex combination of hydrocarbons obtained from a petroleum fraction by solvent crystallisation (solvent dewaxing) or as a distillation fraction from a very waxy crude. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C 20 .) 649-244-00-5 265-165-5 64742-61-6 N Slack wax (petroleum), acid-treated; Slack wax (A complex combination of hydrocarbons obtained as a raffinate by treatment of a petroleum slack wax fraction with sul phuric acid treating process. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C 20 .) 649-245-00-0 292-659-8 90669-77-5 N Slack wax (petroleum), clay-treated; Slack wax (A complex combination of hydrocarbons obtained by treatment of a petroleum slack wax fraction with natural or modified clay in either a contacting or percol ation process. It consists predominantly of saturated straight and branched hydrocarbons having carbon numbers predominantly greater than C 20 .) 649-246-00-6 292-660-3 90669-78-6 N

647. 30.12.2006 EN Official Journal of the European Union L 396/647 Substances Index number EC number CAS number Notes Slack wax (petroleum), hydrotreated; Slack wax (A complex combination of hydrocarbons obtained by treating slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C 20 .) 649-247-00-1 295-523-6 92062-09-4 N Slack wax (petroleum), low-melting; Slack wax (A complex combination of hydrocarbons obtained from a petroleum fraction by solvent deparaffination. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C 12 .) 649-248-00-7 295-524-1 92062-10-7 N Slack wax (petroleum), low-melting, hydrotreated; Slack wax (A complex combination of hydrocarbons obtained by treatment of low-melting petroleum slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C 12 .) 649-249-00-2 295-525-7 92062-11-8 N

648. L 396/648 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Slack wax (petroleum), low-melting, carbon-treated; Slack wax (A complex combination of hydrocarbons obtained by the treatment of low-melting slack wax with activated carbon for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C 12 .) 649-250-00-8 308-155-9 97863-04-2 N Slack wax (petroleum), low-melting, clay-treated; Slack wax (A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with bentonite for removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C 12 .) 649-251-00-3 308-156-4 97863-05-3 N

649. 30.12.2006 EN Official Journal of the European Union L 396/649 Substances Index number EC number CAS number Notes Slack wax (petroleum), low-melting, silicic acid-treated; Slack wax (A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C 12 .) 649-252-00-9 308-158-5 97863-06-4 N Slack wax (petroleum), carbon-treated; Slack wax (A complex combination of hydrocarbons obtained by treatment of petroleum slack wax with activated charcoal for the removal of trace polar constituents and impurities.) 649-253-00-4 309-723-9 100684-49-9 N Petrolatum; Petrolatum (A complex combination of hydrocarbons obtained as a semi-solid from dewaxing paraffinic residual oil. It consists predominantly of saturated crystalline and liquid hydrocarbons having carbon numbers predominantly greater than C 25 .) 649-254-00-X 232-373-2 8009-03-8 N

650. L 396/650 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Petrolatum (petroleum), oxidised; Petrolatum (A complex combination of organic compounds, predominantly high molecular weight carboxylic acids, obtained by the air oxidation of petrolatum.) 649-255-00-5 265-206-7 64743-01-7 N Petrolatum (petroleum), alumina-treated; Petrolatum (A complex combination of hydrocarbons obtained when petrolatum is treated with Al 2 O 3 to remove polar components and impurities. It consists predominantly of saturated, crystalline, and liquid hydrocarbons having carbon numbers predominantly greater than C 25 .) 649-256-00-0 285-098-5 85029-74-9 N Petrolatum (petroleum), hydrotreated; Petrolatum (A complex combination of hydrocarbons obtained as a semi-solid from dewaxed paraffinic residual oil treated with hydrogen in the presence of a catalyst. It consists predominantly of saturated, microcrystalline, and liquid hydrocarbons having carbon numbers predominantly greater than C 20 .) 649-257-00-6 295-459-9 92045-77-7 N

651. 30.12.2006 EN Official Journal of the European Union L 396/651 Substances Index number EC number CAS number Notes Petrolatum (petroleum), carbon-treated; Petrolatum (A complex combination of hydrocarbons obtained by the treatment of petroleum petrolatum with activated carbon for the removal of trace polar constituents and impurities. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly greater than C 20 .) 649-258-00-1 308-149-6 97862-97-0 N Petrolatum (petroleum), silicic acid-treated; Petrolatum (A complex combination of hydrocarbons obtained by the treatment of petroleum petrolatum with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly greater than C 20 .) 649-259-00-7 308-150-1 97862-98-1 N

652. L 396/652 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Petrolatum (petroleum), clay-treated; Petrolatum (A complex combination of hydrocarbons obtained by treatment of petrolatum with bleaching earth for the removal of traces of polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of greater than C 25 .) 649-260-00-2 309-706-6 100684-33-1 N Gasoline, natural; Low boiling point naphtha (A complex combination of hydrocarbons separated from natural gas by processes such as refrigeration or absorption. It consists predominantly of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C 4 through C 8 and boiling in the range of approximately -20°C to 120°C.) 649-261-00-8 232-349-1 8006-61-9 P Naphtha; Low boiling point naphtha (Refined, partly re fined, or unrefined petroleum products by the distillation of natural gas. It consists of hydrocarbons having carbon numbers predominantly in the range of C 5 through C 6 and boiling in the range of approximately 100°C to 200°C.) 649-262-00-3 232-443-2 8030-30-6 P

653. 30.12.2006 EN Official Journal of the European Union L 396/653 Substances Index number EC number CAS number Notes Ligroine; Low boiling point naphtha (A complex combination of hydrocarbons obtained by the fractional distillation of petroleum. This fraction boils in a range of approximately 20°C to 135°C.) 649-263-00-9 232-453-7 8032-32-4 P Naphtha (petroleum), heavy straight-run; Low boiling point naphtha (A complex combination of hydrocarbons produced by distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C 6 through C 12 and boiling in the range of approximately 65°C to 230°C.) 649-264-00-4 265-041-0 64741-41-9 P Naphtha (petroleum), full-range straight-run; Low boiling point naphtha (A complex combination of hydrocarbons produced by distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C 4 through C 11 and boiling in the range of approximately -20°C to 220°C.) 649-265-00-X 265-042-6 64741-42-0 P Naphtha (petroleum), light straight-run; Low boiling point naphtha 649-266-00-5 265-046-8 64741-46-4 P

654. L 396/654 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons produced by distillation of crude oil. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C 4 through C 10 and boiling in the range of approximately -20°C to 180°C.) Solvent naphtha (petroleum), light aliph.; Low boiling point naphtha (A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocar bons having carbon numbers predominantly in the range of C 5 through C 10 and boiling in the range of approximately 35°C to 160°C.) 649-267-00-0 265-192-2 64742-89-8 P Distillates (petroleum), straight-run light; Low boiling point naphtha (A complex combination of hydrocarbons produced by the distillation of crude o il. It consists of hydrocarbons having carbon numbers predominantly in the range of C 2 through C 7 and boiling in the range of approximately -88°C to 99°C.) 649-268-00-6 270-077-5 68410-05-9 P Gasoline, vapour-recovery; Low boiling point naphtha 649-269-00-1 271-025-4 68514-15-8 P

655. 30.12.2006 EN Official Journal of the European Union L 396/655 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons separated from the gases from vapour recovery systems by cooling. It consists of hydrocarbons having carbon numbers predominantly in the range of C 4 through C 11 and boiling in the range of approximately -20°C to 196°C.) Gasoline, straight-run, topping-plant; Low boiling point naphtha (A complex combination of hydrocarbons produced from the topping plant by the distillation of crude oil. It boils in the range of approximately 36,1°C to 193,3°C.) 649-270-00-7 271-727-0 68606-11-1 P Naphtha (petroleum), unsweetened; Low boiling point naphtha (A complex combination of hydrocarbons produced from the distillation of naphtha streams from various refinery proc esses. It consists of hydrocarbons having carbon numbers predominantly in the range of C 5 through C 12 and boiling in the range of approximately 0°C to 230°C.) 649-271-00-2 272-186-3 68783-12-0 P

656. L 396/656 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (petroleum), light straight-run gasoline fractionation stabiliser overheads; Low boiling point naphtha (A complex combination of hydrocarbons having carbon numbers predominantly in the range of C 3 through C 6 .) 649-272-00-8 272-931-2 68921-08-4 P Naphtha (petroleum), heavy straight run, arom.-contg.; Low boiling point naphtha (A complex combination of hydrocarbons obtained from a distillation process of crude petroleum. It consists predominantly of hydrocarbons having carbon numbers in the range of C 8 through C 12 and boiling in the range of approximately 130°C to 210°C.) 649-273-00-3 309-945-6 101631-20-3 P

657. 30.12.2006 EN Official Journal of the European Union L 396/657 Substances Index number EC number CAS number Notes Naphtha (petroleum), full-range alkylate; Low boiling point modified naphtha (A complex combination of hydrocarbons produced by distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C 3 through C 5 . It consists of predominantly branched chain saturated hydro-carbons having carbon numbers predominantly in the range of C 7 through C 12 and boiling in the range of approximately 90°C to 220°C.) 649-274-00-9 265-066-7 64741-64-6 P Naphtha (petroleum), heavy alkylate; Low boiling point modified naphtha 649-275-00-4 265-067-2 64741-65-7 P (A complex combination of hydrocarbons produced by distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C 3 to C 5 . It consists of predominantly branched chain saturated hydrocar bons having carbon numbers predominantly in the range of C 9 through C 12 and boiling in the range of approximately 150°C to 220°C.)

658. L 396/658 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Naphtha (petroleum), light alkylate; Low boiling point modified naphtha (A complex combination of hydrocarbons produced by distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C 3 through C 5 . It consists of predominantly branched chain saturated hydro-carbons having carbon numbers predominantly in the range of C 7 through C 10 and boiling in the range of approximately 90°C to 160°C.) 649-276-00-X 265-068-8 64741-66-8 P Naphtha (petroleum), isomerisation; Low boiling point modified naphtha (A complex combination of hydrocarbons obtained from catalytic isomerisation of straight chain paraffinic C 4 through C 6 hydrocarbons. It consists predominantly of saturated hydrocarbons such as isobutane, isopentane, 2,2-dimethylbutane, 2-methylpentane, and 3-methylpentane.) 649-277-00-5 265-073-5 64741-70-4 P

659. 30.12.2006 EN Official Journal of the European Union L 396/659 Substances Index number EC number CAS number Notes Naphtha (petroleum), solvent-refined light; Low boiling point modified naphtha (A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C 5 through C 11 and boiling in the range of approximately 35°C to 190°C.) 649-278-00-0 265-086-6 64741-84-0 P Naphtha (petroleum), solvent-refined heavy; Low boiling point modified naphtha (A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C 7 through C 12 and boiling in the range of approximately 90°C to 230°C.) 649-279-00-6 265-095-5 64741-92-0 P

660. L 396/660 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Raffinates (petroleum), catalytic reformer ethylene glycol-water countercurrent exts.; Low boiling point modified naphtha (A complex combination of hydrocarbons obtained as the raffinate from the UDEX extraction process on the catalytic reformer stream. It consists of saturated hydrocarbons having carbon numbers predominantly in the range of C 6 through C 9 .) 649-280-00-1 270-088-5 68410-71-9 P Raffinates (petroleum), reformer, Lurgi unit-sepd.; Low boiling point modified naphtha (The complex combination of hydrocarbons obtained as a raffinate from a Lurgi separation unit. It consists predominantly of non-aromatic hydrocarbons with various small amounts of aromatic hydrocarbons having carbon numbers predominantly in the range of C 6 through C 8 .) 649-281-00-7 270-349-3 68425-35-4 P

661. 30.12.2006 EN Official Journal of the European Union L 396/661 Substances Index number EC number CAS number Notes Naphtha (petroleum), full-range alkylate, butane-contg.; Low boiling point modified naphtha (A complex combination of hydrocarbons produced by the distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C 3 through C 5 . It consists of predominantly branched chain saturated hydrocarbons having carbon numbers predominantly in the range of C 7 through C 12 with some butanes and boiling in the range of approximately 35°C to 200°C.) 649-282-00-2 271-267-0 68527-27-5 P Distillates (petroleum), naphtha steam cracking-derived, solvent-refined light hydrotreated; Low boiling point modified naphtha 649-283-00-8 295-315-5 91995-53-8 P

662. L 396/662 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained as the raffinates from a solvent extraction process of hydrotreat ed light distillate from steam-cracked naphtha.) Naphtha (petroleum), C 4-12 butane-alkylate, isooctane-rich; Low boiling point modified naphtha (A complex combination of hydrocarbons obtained by alkylation of butanes. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 4 through C 12 , rich in isooctane, and boiling in the range of approximately 35°C to 210°C.) 649-284-00-3 295-430-0 92045-49-3 P Hydrocarbons, hydrotreated light naphtha distillates, solvent-refined; Low boiling point modified naphtha (A combination of hydrocarbons obtained from the distillation of hydrotreated naphtha followed by a solvent extraction and distillation process. It consists predominantly of saturated hydrocarbons boiling in the range of approximately 94°C to 99°C.) 649-285-00-9 295-436-3 92045-55-1 P Naphtha (petroleum), isomerisation, C 6 -fraction; Low boiling point modified naphtha 649-286-00-4 295-440-5 92045-58-4 P

663. 30.12.2006 EN Official Journal of the European Union L 396/663 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by distillation of a gasoline which has been catalytically isomer ised. It consists predominantly of hexane isomers boiling in the range of approximately 60°C to 66°C.) Hydrocarbons, C 6-7 , naphtha-cracking, solvent-refined; Low boiling point modified naphtha (A complex combination of hydrocarbons obtained by the sorption of benzene from a catalytically fully hydrogenated benzene-rich hydrocarbon cut that was distillatively obtained from prehydrogenated cracked naphtha. It consists predominantly of paraffinic and naphthenic hydrocarbons having carbon numbers predominantly in the range of C 6 through C 7 and boiling in the range of approximately 70°C to 100°C.) 649-287-00-X 295-446-8 92045-64-2 P

664. L 396/664 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Hydrocarbons, C 6 -rich, hydrotreated light naphtha distillates, solvent-refined; Low boiling point modified naphtha (A complex combination of hydrocarbons obtained by distillation of hydrotreated naphtha followed by solvent extraction. It consists predominantly of saturated hydrocarbons and boiling in the range of approximately 65°C to 70°C.) 649-288-00-5 309-871-4 101316-67-0 P Naphtha (petroleum), heavy catalytic cracked; Low boiling point cat-cracked naphtha (A complex combination of hydrocarbons produced by a distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 6 through C 12 and boiling in the range of approximately 65°C to 230°C. It contains a relatively large proportion of unsaturated hydrocarbons.) 649-289-00-0 265-055-7 64741-54-4 P

665. 30.12.2006 EN Official Journal of the European Union L 396/665 Substances Index number EC number CAS number Notes Naphtha (petroleum), light catalytic cracked; Low boiling point cat-cracked naphtha (A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 4 through C 11 and boiling in the range of approximately -20°C to 190°C. It contains a relatively large proportion of unsaturated hydrocarbons.) 649-290-00-6 265-056-2 64741-55-5 P Hydrocarbons, C 3-11 , catalytic cracker distillates; Low boiling point cat-cracked naphtha 649-291-00-1 270-686-6 68476-46-0 P

666. L 396/666 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons produced by the distillations of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 3 through C 11 and boiling in a range approximately up to 204°C.) Naphtha (petroleum), catalytic cracked light distd.; Low boiling point cat-cracked naphtha (A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-292-00-7 272-185-8 68783-09-5 P Distillates (petroleum), naphtha steam cracking-derived, hydrotreated light arom.; Low boiling point cat-cracked naphtha (A complex combination of hydrocarbons obtained by treating a light distillate from steam-cracked naphtha. It consists predominantly of aromatic hydrocarbons.) 649-293-00-2 295-311-3 91995-50-5 P

667. 30.12.2006 EN Official Journal of the European Union L 396/667 Substances Index number EC number CAS number Notes Naphtha (petroleum), heavy catalytic cracked, sweetened; Low boiling point cat-cracked naphtha 649-294-00-8 295-431-6 92045-50-6 P (A complex combination of hydrocarbons obtained by subjecting a catalytic cracked petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 6 through C 12 and boiling in the range of approximately 60°C to 200°C.) Naphtha (petroleum), light catalytic cracked sweetened; Low boiling point cat-cracked naphtha (A complex combination of hydrocarbons obtained by subjecting naphtha from a catalytic cracking process to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons boiling in a range of approximately 35°C to 210°C.) 649-295-00-3 295-441-0 92045-59-5 P

668. L 396/668 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Hydrocarbons, C 8-12 , catalytic-cracking, chem. neutralised; Low boiling point cat-cracked naphtha (A complex combination of hydrocarbons produced by the distillation of a cut from the catalytic cracking process, having undergone an alkaline washing. It consists predominantly of hydrocarbons having carbon numbers in the range of C 8 through C 12 and boiling in the range of approximately 130°C to 210°C.) 649-296-00-9 295-794-0 92128-94-4 P Hydrocarbons, C 8-12 , catalytic cracker distillates; Low boiling point cat-cracked naphtha (A complex combination of hydrocarbons obtained by distillation of products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 8 through C 12 and boiling in the range of approximately 140°C to 210°C.) 649-297-00-4 309-974-4 101794-97-2 P Hydrocarbons, C 8-12 , catalytic cracking, chem. neutralised, sweetened; Low boiling point cat-cracked naphtha 649-298-00-X 309-987-5 101896-28-0 P

669. 30.12.2006 EN Official Journal of the European Union L 396/669 Substances Index number EC number CAS number Notes Naphtha (petroleum), light catalytic reformed; Low boiling point cat-reformed naphtha (A complex combination of hydrocarbons produced from the distillation of products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 5 through C 11 and boiling in the range of approximately 35°C to 190°C. It contains a relatively large proportion of aromatic and branched chain hydrocarbons. This stream may contain 10 vol. % or more benzene.) 649-299-00-5 265-065-1 64741-63-5 P Naphtha (petroleum), heavy catalytic reformed; Low boiling point cat-reformed naphtha 649-300-00-9 265-070-9 64741-68-0 P (A complex combination of hydrocarbons produced from the distillation of products from a catalytic reforming process. It consists of predominantly aromatic hydrocarbons having numbers predominantly in the range of C 7 through C 12 and boiling in the range of approximately 90°C to 230°C.)

670. L 396/670 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (petroleum), catalytic reformed depentaniser; Low boiling point cat-reformed naphtha (A complex combination of hydrocarbons from th e distillation of products from a catalytic reforming process. It consists predominantly of aliphatic hydrocar bons having carbon numbers predominantly in the range of C 3 through C 6 and boiling in the range of approximately -49°C to 63°C.) 649-301-00-4 270-660-4 68475-79-6 P Hydrocarbons, C 2-6 , C 6-8 catalytic reformer; Low boiling point cat-reformed naphtha 649-302-00-X 270-687-1 68476-47-1 P Residues (petroleum), C 6-8 catalytic reformer; Low boiling point cat-reformed naphtha (A complex residuum from the catalytic reforming of C 6-8 feed. It consists of hydrocarbons having carbon numbers predominantly in the range of C 2 through C 6 .) 649-303-00-5 270-794-3 68478-15-9 P

671. 30.12.2006 EN Official Journal of the European Union L 396/671 Substances Index number EC number CAS number Notes Naphtha (petroleum), light catalytic reformed, arom.-free; Low boiling point cat-reformed naphtha (A complex combination of hydrocarbons obtained from distillation of products from a catalytic reforming process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 5 through C 8 and boiling in the range of approximately 35°C to 120°C. It contains a relative ly large proportion of branched chain hydrocarbons with the aromatic components removed.) 649-304-00-0 270-993-5 68513-03-1 P Distillates (petroleum), catalytic reformed straight-run naphtha overheads; Low boiling point cat-reformed naphtha (A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha followed by the fractionation of the total effluent. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C 2 through C 6 .) 649-305-00-6 271-008-1 68513-63-3 P Petroleum products, hydrofiner- powerformer reformates; Low boiling point cat-reformed naphtha 649-306-00-1 271-058-4 68514-79-4 P

672. L 396/672 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (The complex combination of hydrocarbons obtained in a hydrofiner-powerformer process and boiling in a range of approximately 27°C to 210°C.) Naphtha (petroleum, full-range reformed; Low boiling point cat-reformed naphtha (A complex combination of hydrocarbons produced by the distillation of the products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 5 through C 12 and boiling in the range of approximately 35°C to 230°C.) 649-307-00-7 272-895-8 68919-37-9 P Naphtha (petroleum), catalytic reformed; Low boiling point cat-reformed naphtha (A complex combination of hydrocarbons produced by the distillation of products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 4 through C 12 and boiling in the range of approximately 30°C to 220°C. It contains a relatively large proportion of aromatic and branched chain hydrocarbons. This stream may contain 10 vol. % or more benzene.) 649-308-00-2 273-271-8 68955-35-1 P

673. 30.12.2006 EN Official Journal of the European Union L 396/673 Substances Index number EC number CAS number Notes Distillates (petroleum), catalytic reformed hydrotreated light, C 8-12 arom. fraction; Low boiling point cat-reformed naphtha (A complex combination of alkylbenzenes obtained by the catalytic reforming of petroleum naphtha. It consists predominantly of alkylbenzenes having carbon numbers predominantly in the range of C 8 through C 10 and boiling in the range of approximately 160°C to 180°C.) 649-309-00-8 285-509-8 85116-58-1 P Aromatic hydrocarbons, C 8 , catalytic reforming-derived; Low boiling point cat-reformed naphtha 649-310-00-3 295-279-0 91995-18-5 P Aromatic hydrocarbons, C 7-12 , C 8- rich; Low boiling point cat-reformed naphtha (A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 7 through C 12 (primarily C 8 ) and can contain nonaromatic hydrocarbons, both boiling in the range of approximately 130°C to 200°C.) 649-311-00-9 297-401-8 93571-75-6 P

674. L 396/674 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gasoline, C 5-11 , high-octane stabilised reformed; Low boiling point cat-reformed naphtha 649-312-00-4 297-458-9 93572-29-3 P (A complex high octane combination of hydrocarbons obtained by the catalytic dehydrogenation of a predominantly naphthenic naphtha. It consists predominantly of aromatics and non-aromatics having carbon numbers predominantly in the range of C 5 through C 11 and boiling in the range of approximately 45°C to 185°C.) Hydrocarbons, C 7-12 , C > 9- -arom.- rich, reforming heavy fraction; Low boiling point cat-reformed naphtha (A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of nonaromatic hydrocarbons having carbon numbers predominantly in the range of C 7 through C 12 and boiling in the range of approximately 120°C to 210°C and C 9 and higher aromatic hydrocarbons.) 649-313-00-X 297-465-7 93572-35-1 P

675. 30.12.2006 EN Official Journal of the European Union L 396/675 Substances Index number EC number CAS number Notes Hydrocarbons, C 5-11 , nonaroms.-rich, reforming light fraction; Low boiling point cat-reformed naphtha (A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of nonaromatic hydrocarbons having carbon numbers predominantly in the range of C 5 to C 11 and boiling in the range of approximately 35°C to 125°C, benzene and toluene.) 649-314-00-5 297-466-2 93572-36-2 P Foots oil (petroleum), silicic acid-treated; Foots oil (A complex combination of hydrocarbons obtained by the treatment of Foots oil with silicic acid for removal of trace constituents and impurities. It consists predominantly of straight chain hydrocarbons having carbon numbers predominantly greater than C 12 .) 649-315-00-0 308-127-6 97862-77-6 L

677. 30.12.2006 EN Official Journal of the European Union L 396/677 Substances Index number EC number CAS number Notes Distillates (petroleum), heavy arom.; Low boiling point thermally cracked naphtha (The complex combination of hydrocarbons from th e distillation of products from the thermal cracking of ethane and propane. This higher boiling fraction consists predominantly of C 5 -C 7 aromatic hydrocarbons with some unsaturated aliphatic hydrocarbons having a carbon number predominantly of C 5 . This stream may contain benzene.) 649-318-00-7 267-563-4 67891-79-6 P Distillates (petroleum), light arom.; Low boiling point thermally cracked naphtha (The complex combination of hydrocarbons from th e distillation of products from the thermal cracking of ethane and propane. This lower boiling fraction consists predominantly of C 5 -C 7 aromatic hydrocarbons with some unsaturated aliphatic hydrocarbons having a carbon number predominantly of C 5 . This stream may contain benzene.) 649-319-00-2 267-565-5 67891-80-9 P Distillates (petroleum), naphtha-raffinate py rolyzate-derived, gasoline-blending; Low boiling point thermally cracked naphtha 649-320-00-8 270-344-6 68425-29-6 P

678. L 396/678 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (The complex combination of hydrocarbons obtained by the pyrolysis fractionation at 816°C of naphtha and raffinate. It consists predominantly of hydrocarbons having a carbon number of C 9 and boiling at approximately 204°C.) Aromatic hydrocarbons, C 6-8 , naphtha-raffinate py rolyzate-derived; Low boiling point thermally cracked naphtha (A complex combination of hydrocarbons obtained by the fractionation pyrolysis at 816°C of naphtha and raffinate. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 6 through C 8 , including benzene.) 649-321-00-3 270-658-3 68475-70-7 P Distillates (petroleum), thermal cracked naphtha and gas oil; Low boiling point thermally cracked naphtha (A complex combination of hydrocarbons produced by distillation of thermally cracked naphtha and/or gas oil. It consists predominantly of olefinic hydrocarbons having a carbon number of C 5 and boiling in the range of approximately 33°C to 60°C.) 649-322-00-9 271-631-9 68603-00-9 P

679. 30.12.2006 EN Official Journal of the European Union L 396/679 Substances Index number EC number CAS number Notes Distillates (petroleum), thermal cracked naphtha and gas oil, C 5 -dimer-contg.; Low boiling point thermally cracked naphtha (A complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists predominantly of hydrocarbons having a carbon number of C 5 with some dimerised C 5 olefins and boiling in the range of approximately 33°C to 184°C.) 649-323-00-4 271-632-4 68603-01-0 P Distillates (petroleum), thermal cracked naphtha and gas oil, extractive; Low boiling point thermally cracked naphtha (A complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists of paraffinic and olefinic hydrocarbons predominantly isoamylenes such as 2-methyl-1- butene and 2-methyl-2-butene and boiling in the range of approximately 31°C to 40°C.) 649-324-00-X 271-634-5 68603-03-2 P

680. L 396/680 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (petroleum), light thermal cracked, debutanised arom.; Low boiling point thermally cracked naphtha 649-325-00-5 273-266-0 68955-29-3 P (A complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists predominantly of aromatic hydrocarbons, primarily benzene.) Naphtha (petroleum), light thermal cracked, sweetened; Low boiling point thermally cracked naphtha (A complex combination of hydrocarbons obtained by subjecting a petroleum distillate from the high temperature thermal cracking of heavy oil fractions to a sweetening process to convert mercaptans. It consists predominantly of aromatics, olefins and saturated hydrocarbons boiling in the range of approximately 20°C to 100°C.) 649-326-00-0 295-447-3 92045-65-3 P

681. 30.12.2006 EN Official Journal of the European Union L 396/681 Substances Index number EC number CAS number Notes Naphtha (petroleum), hydrotreated heavy; Low boiling point hydrogen treated naphtha (A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C 6 through C 13 and boiling in the range of approximately 65°C to 230°C.) 649-327-00-6 265-150-3 64742-48-9 P

682. L 396/682 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Naphtha (petroleum), hydrotreated light; Low boiling point hydrogen treated naphtha (A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C 4 through C 11 and boiling in the range of approximately -20°C to 190°C.) 649-328-00-1 265-151-9 64742-49-0 P Naphtha (petroleum), hydrodesulphurised light; Low boiling point hydrogen treated naphtha (A complex combination of hydrocarbons obtained from a catalytic hydrodesulphurisation process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 4 through C 11 and boiling in the range of approximately -20°C to 190°C.) 649-329-00-7 265-178-6 64742-73-0 P

683. 30.12.2006 EN Official Journal of the European Union L 396/683 Substances Index number EC number CAS number Notes Naphtha (petroleum), hydrodesulphurised heavy; Low boiling point hydrogen treated naphtha (A complex combination of hydrocarbons obtained from a catalytic hydrodesulphurisation process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 7 through C 12 and boiling in the range of approximately 90°C to 230°C.) 649-330-00-2 265-185-4 64742-82-1 P Distillates (petrole um), hydrotreated middle, intermediate boiling; Low boiling point hydrogen treated naphtha (A complex combination of hydrocarbons obtained by the distillation of products from a middle distillate hydrotre ating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 5 through C 10 and boiling in the range of approximately 127°C to 188°C.) 649-331-00-8 270-092-7 68410-96-8 P

685. 30.12.2006 EN Official Journal of the European Union L 396/685 Substances Index number EC number CAS number Notes Solvent naphtha (petroleum), light arom., hydrotreated; Low boiling point hydrogen treated naphtha (A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 8 through C 10 and boiling in the range of approximately 135°C to 210°C.) 649-334-00-4 270-988-8 68512-78-7 P Naphtha (petroleum), hydrodesulphurised thermal cracked light; Low boiling point hydrogen treated naphtha (A complex combination of hydrocarbons obtained by fractionation of hydrodesulphurised thermal cracker distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 5 to C 11 and boiling in the range of approximately 23°C to 195°C.) 649-335-00-X 285-511-9 85116-60-5 P

687. 30.12.2006 EN Official Journal of the European Union L 396/687 Substances Index number EC number CAS number Notes Naphtha (petroleum), hydrotreated light steam-cracked; Low boiling point hydrogen treated naphtha 649-339-00-1 295-438-4 92045-57-3 P (A complex combination of hydrocarbons obtained by treating a petroleum fraction, derived from a pyrolysis process, with hydrogen in the presence of a catalyst. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C 5 through C 11 and boiling in the range of approximately 35°C to 190°C.) Hydrocarbons, C 4-12 , naphtha-cracking, hydrotreated; Low boiling point hydrogen treated naphtha (A complex combination of hydrocarbons obtained by distillation from the product of naphtha steam cracking process and subsequent catalytic selective hydrogenation of gum formers. It consists of hydrocarbons having carbon numbers predominantly in the range of C 4 through C 12 and boiling in the range of approximately 30°C to 230°C.) 649-340-00-7 295-443-1 92045-61-9 P

688. L 396/688 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Solvent naphtha (petroleum), hydrotreated light naphthenic; Low boiling point hydrogen treated naphtha (A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of cycloparaffinic hydrocarbons having carbon numbers predominantly in the range of C 6 through C 7 and boiling in the range of approximately 73°C to 85°C.) 649-341-00-2 295-529-9 92062-15-2 P Naphtha (petroleum), light steam-cracked, hydrogenated; Low boiling point hydrogen treated naphtha (A complex combination of hydrocarbons produced from the separation and subsequent hydrogenation of the products of a steam-cracking process to produce ethylene. It consists predominantly of saturated and unsaturated paraffins, cyclic paraffins and cyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C 4 through C 10 and boiling in the range of approximately 50°C to 200°C. The proportion of benzene hydrocarbons may vary up to 30 wt. % and the stream may also contain small amounts of sulphur and oxygenated compounds.) 649-342-00-8 296-942-7 93165-55-0 P

689. 30.12.2006 EN Official Journal of the European Union L 396/689 Substances Index number EC number CAS number Notes Hydrocarbons, C 6-11 , hydrotreated, dearomatised; Low boiling point hydrogen treated naphtha (A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.) 649-343-00-3 297-852-0 93763-33-8 P Hydrocarbons, C 9-12 , hydrotreated, dearomatised; Low boiling point hydrogen treated naphtha 649-344-00-9 297-853-6 93763-34-9 P (A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.) Stoddard solvent; Low boiling point naphtha – unspecified (A colourless, refined petroleum distillate that is free from rancid or objectionable odours and that boils in a range of approximately 149°C to 205°C.) 649-345-00-4 232-489-3 8052-41-3 P

690. L 396/690 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Natural gas condensates (petroleum); Low boiling point naphtha – unspecified (A complex combination of hydrocarbons separated as a liquid from natural gas in a surface separator by retrograde condensation. It consists mainly of hydrocarbons having carbon numbers predominantly in the range of C 2 to C 20 . It is a liquid at atmospheric temperature and pressure.) 649-346-00-X 265-047-3 64741-47-5 P Natural gas (petroleum), raw liq. mix; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons separated as a liquid from natural gas in a gas recycling plant by processes such as refrigeration or absorption. It consists mainly of saturated aliphatic hydrocarbons having carbon numbers in the range of C 2 through C 8 .) 649-347-00-5 265-048-9 64741-48-6 P

692. L 396/692 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Naphtha (petroleum), sweetened; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C 4 through C 12 and boiling in the range of approximately -10°C to 230°C.) 649-350-00-1 265-089-2 64741-87-3 P Naphtha (petroleum), acid-treated; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained as a raffinate from a sulphuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 7 through C 12 and boiling in the range of approximately 90°C to 230°C.) 649-351-00-7 265-115-2 64742-15-0 P

693. 30.12.2006 EN Official Journal of the European Union L 396/693 Substances Index number EC number CAS number Notes Naphtha (petroleum), chemically neutralised heavy; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C 6 through C 12 and boiling in the range of approximately 65°C to 230°C.) 649-352-00-2 265-122-0 64742-22-9 P Naphtha (petroleum), chemically neutralised light; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C 4 through C 11 and boiling in the range of approximately -20°C to 190°C.) 649-353-00-8 265-123-6 64742-23-0 P

694. L 396/694 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Naphtha (petroleum), catalytic dewaxed; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained from the catalytic dewaxing of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 5 through C 12 and boiling in the range of approximately 35°C to 230°C.) 649-354-00-3 265-170-2 64742-66-1 P Naphtha (petroleum), light steam-cracked; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained by the distillation of the products from a steam cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C 4 through C 11 and boiling in the range of approximately -20°C to 190°C. This stream is likely to contain 10 vol. % or more benzene.) 649-355-00-9 265-187-5 64742-83-2 P

695. 30.12.2006 EN Official Journal of the European Union L 396/695 Substances Index number EC number CAS number Notes Solvent naphtha (petroleum), light arom.; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained from distillation of aromatic streams. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 8 through C 10 and boiling in the range of approximately 135°C to 210°C.) 649-356-00-4 265-199-0 64742-95-6 P Aromatic hydrocarbons, C 6-10 , acid-treated, neutralised; Low boiling point naphtha – unspecified 649-357-00-X 268-618-5 68131-49-7 P Distillates (petroleum), C 3-5 , 2-methyl-2-butene-rich; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons from th e distillation of hydrocarbons usually ranging in carbon numbers from C 3 through C 5 , predominantly isopentane and 3-methyl-1-butene. It consists of saturated and unsaturated hydrocarbons having carbon numbers in the range of C 3 through C 5 , predominantly 2-methyl-2-butene.) 649-358-00-5 270-725-7 68477-34-9 P

696. L 396/696 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (petroleum), polymd. steam-cracked petroleum distillates, C 5-12 fraction; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained from the distillation of polymerised steam-cracked petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 5 through C 12 .) 649-359-00-0 270-735-1 68477-50-9 P Distillates (petroleum), steam-cracked, C 5-12 fraction; Low boiling point naphtha – unspecified 649-360-00-6 270-736-7 68477-53-2 P (A complex combination of organic compounds obtained by the distillation of products from a steam cracking process. It consists of unsaturated hydrocarbons having carbon numbers predominantly in the range of C 5 through C 12 .) Distillates (petroleum), steam-cracked, C 5-10 fraction, mixed with light steam-cracked petroleum naphtha C 5 fraction; Low boiling point naphtha – unspecified 649-361-00-1 270-738-8 68477-55-4 P

697. 30.12.2006 EN Official Journal of the European Union L 396/697 Substances Index number EC number CAS number Notes Extracts (petroleum), cold-acid, C 4-6 ; Low boiling point naphtha – unspecified (A complex combination of organic compounds produced by cold acid unit extraction of saturated and unsaturated aliphatic hydrocarbons usually ranging in carbon numbers from C 3 through C 6 , predominantly pentanes and amylenes. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers in the range of C 4 through C 6 , predominantly C 5 .) 649-362-00-7 270-741-4 68477-61-2 P Distillates (petroleum), depentaniser overheads; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained from a catalytic cracked gas stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C 4 through C 6 .) 649-363-00-2 270-771-8 68477-894-4 P

698. L 396/698 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Residues (petroleum ), butane splitter bottoms; Low boiling point naphtha – unspecified (A complex residuum from the distillation of butane stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C 4 through C 6 .) 649-364-00-8 270-791-7 68478-12-6 P Residual oils (petroleum), deisobutaniser tower; Low boiling point naphtha – unspecified (A complex residuum from the atmospheric distillation of the butane-butylene stream. It consists of aliphatic hydrocar bons having carbon numbers predominantly in the range of C 4 through C 6 .) 649-365-00-3 270-795-9 68478-16-0 P Naphtha (petroleum), full-range coker; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons produced by the distillation of products from a fluid coker. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C 4 through C 15 and boiling in the range of approximately 43°C to 250°C.) 649-366-00-9 270-991-4 68513-02-0 P

699. 30.12.2006 EN Official Journal of the European Union L 396/699 Substances Index number EC number CAS number Notes Naphtha (petroleum), steam-cracked middle arom.; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons produced by the distillation of products from a steam-cracking process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 7 through C 12 and boiling in the range of approximately 130°C to 220°C.) 649-367-00-4 271-138-9 68516-20-1 P Naphtha (petroleum), clay-treated full-range straight-run; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons resulting from treatment of full -range straight-run, naphtha with natural or modified clay, usually in a percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C 4 through C 11 and boiling in the range of approximately -20°C to 220°C.) 649-368-00-X 271-262-3 68527-21-9 P Naphtha (petroleum), clay-treated light straight-run; Low boiling point naphtha – unspecified 649-369-00-5 271-263-9 68527-22-0 P

700. L 396/700 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons resulting from treatment of light straight-run naphtha with a natural or modified clay, usually in a percolation process to remove the trace amounts of polar compounds and impurities, present. It consists of hydro-carbons having carbon numbers predominantly in the range of C 7 through C 10 and boiling in the range of approximately 93°C to 180°C.) Naphtha (petroleum), light steam-cracked arom.; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 7 through C 9 , and boiling in the range of approximately 110°C to 165°C.) 649-370-00-0 271-264-4 68527-23-1 P Naphtha (petroleum), light steam-cracked, debenzenised; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 4 through C 12 and boiling in the range of approximately 80°C to 218°C.) 649-371-00-6 271-266-5 68527-26-4 P

701. 30.12.2006 EN Official Journal of the European Union L 396/701 Substances Index number EC number CAS number Notes Naphtha (petroleum), arom.-contg.; Low boiling point naphtha – unspecified 649-372-00-1 271-635-0 68603-08-7 P Gasoline, pyrolysis, debutaniser bottoms; low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained from the fractionation of depropaniser bottoms. It consists of hydrocarbons having carbon numbers predominantly greater than C 5 .) 649-373-00-7 271-726-5 68606-10-0 P Naphtha (petroleum), light, sweetened; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers predominantly in the range of C 3 through C 6 and boiling in the range of approximately -20°C to 100°C.) 649-374-00-2 272-206-0 68783-66-4 P

702. L 396/702 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Natural gas condensates; Low boiling point naphtha – unspecified 649-375-00-8 272-896-3 68919-39-1 J (A complex combination of hydrocarbons separated and/or condensed from natural gas during transportation and collected at the wellhead and/or from the production, gathering, transmission, and distribution pipelines in deeps, scrubbers, etc. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 2 through C 8 .) Distillates (petroleum), naphtha unifiner stripper; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons produced by stripping the products from the naphtha unifiner. It consists of saturated aliphatic hydrocar bons having carbon numbers predominantly in the range of C 2 through C 6 .) 649-376-00-3 272-932-8 68921-09-5 P

703. 30.12.2006 EN Official Journal of the European Union L 396/703 Substances Index number EC number CAS number Notes Naphtha (petroleum), catalytic reformed light, arom.-free fraction; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons remaining after removal of aromatic compounds from catalytic reformed light naphtha in a selective absorption process. It consists predominantly of paraffinic and cyclic compounds having carbon numbers predominantly in the range of C 5 to C 8 and boiling in the range of approximately 66°C to 121°C.) 649-377-00-9 285-510-3 85116-59-2 P Gasoline; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons consisting primarily of paraffins, cycloparaffins, aromatic and olefinic hydrocarbons having carbon numbers predominantly greater than C 3 and boiling in the range of 30°C to 260°C.) 649-378-00-4 289-220-8 86290-81-5 P

704. L 396/704 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Aromatic hydrocarbons, C 7-8 , dealkylation products, distillation residues; Low boili ng point naphtha – unspecified 649-379-00-X 292-698-0 90989-42-7 P Hydrocarbons, C 4-6 , depentaniser lights, arom. hydrotreater; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained as first runnings from the depentaniser column before hydrotreatment of the aromatic charges. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 4 through C 6 , predominantly pentanes and pentenes, and boiling in the range of approximately 25°C to 40°C.) 649-380-00-5 295-298-4 91995-38-9 P Distillates (petroleum), heat-soaked steam-cracked naphtha, C 5 -rich; Low boiling point naphtha – unspecified 649-381-00-0 295-302-4 91995-41-4 P

705. 30.12.2006 EN Official Journal of the European Union L 396/705 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by distillation of heat-soaked steam-cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C 4 through C 6 , predominantly C 5 .) Extracts (petroleum), catalytic reformed light naphtha solvent; low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained as the extract from the solvent extraction of a catalytically reformed petroleum cut. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 7 through C 8 and boiling in the range of approximately 100°C to 200°C.) 649-382-00-6 295-331-2 91995-68-5 P Naphtha (petroleum), hydrodesulphurised light, dearomatised; low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained by distillation of hydrodesulphurised and dearomatised light petroleum fractions. It consists predominantly of C 7 paraffins and cycloparaffins boiling in a range of approximately 90°C to 100°C.) 649-383-00-1 295-434-2 92045-53-9 P

706. L 396/706 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Naphtha (petroleum), light, C 5 -rich, sweetened; low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C 4 through C 5 , predominantly C 5 , and boiling in the range of approximately -10°C to 35°C.) 649-384-00-7 295-442-6 92045-60-8 P Hydrocarbons, C 8-11 , naphtha-cracking, toluene cut; low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained by distillation from prehydrogenated cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 8 through C 11 and boiling in the range of approximately 130°C to 205°C.) 649-385-00-2 295-444-7 92045-62-0 P Hydrocarbons, C 4-11 , naphtha-cracking; arom.-free; low boiling point naphtha – unspecified 649-386-00-8 295-445-2 92045-63-1 P

707. 30.12.2006 EN Official Journal of the European Union L 396/707 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained from prehydrogenated cracked naphtha after distillative separation of benzene- and toluene-containing hydrocarbon cuts and a higher boiling fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 4 through C 11 and boiling in the range of approximately 30°C to 205°C.) Naphtha (petroleum), light heat-soaked, steam-cracked; low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained by the fractionation of steam cracked naphtha after recovery from a heat soaking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 4 through C 6 and boiling in the range of approximately 0°C to 80°C.) 649-387-00-3 296-028-8 92201-97-3 P Distillates (petroleum), C 6 -rich; low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained from the distillation of a petroleum feedstock. It consists predominantly of hydrocarbons having carbon numbers of C 5 through C 7 , rich in C 6 , and boiling in the range of approximately 60°C to 70°C.) 649-388-00-9 296-903-4 93165-19-6 P

708. L 396/708 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gasoline, pyrolysis, hydrogenated; low boiling point naphtha – unspecified (A distillation fraction from the hydrogenation of pyrolysis gasoline boiling in the range of approximately 20°C to 200°C.) 649-389-00-4 302-639-3 94114-03-1 P Distillates (petroleum), steam-cracked, C 8-12 fraction, polymd., distillation lights; low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained by distillation of the polymerised C 8 through C 12 fraction from steam-cracked petroleum distillates. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 8 through C 12 .) 649-390-00-X 305-750-5 95009-23-7 P Extracts (petroleum); heavy naphtha solvent, clay-treated; low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained by the treatment of hea vy naphthic solvent petroleum extract with bleaching earth. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 6 through C 10 , and boiling in the range of approximately 80°C to 180°C.) 649-391-00-5 308-261-5 97926-43-7 P

709. 30.12.2006 EN Official Journal of the European Union L 396/709 Substances Index number EC number CAS number Notes Naphtha (petroleum), light steam-cracked, debenzenised, thermally treated; low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained by the treatment and distillation of debenzenised light steam-cracked petroleum naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 7 through C 12 and boiling in the range of approximately 95°C to 200°C.) 649-392-00-0 308-713-1 98219-46-6 P Naphtha (petroleum), light steam-cracked, thermally treated; low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained by the treatment and distillation of light steam-cracked petroleum naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 5 through C 6 and boiling in the range of approximately 35°C to 80°C.) 649-393-00-6 308-714-7 98219-47-7 P Distillates (petroleum), C 7-9 , C 8 -rich, hydrodesulphurised dearomatised; low boiling point naphtha – unspecified 649-394-00-1 309-862-5 101316-56-7 P

710. L 396/710 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by the distillation of petroleum light fraction, hydrodesulphurised and dearomatised. It consists predominantly of hydrocarbons having carbon numbers in the range of C 7 through C 9 , predominantly C 8 paraffins and cycloparaffins, boiling in the range of approximately 120°C to 130°C.) Hydrocarbons, C 6-8 , hydrogenated sorption-dearomatised, toluene raffination; low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained during the sorption of toluene from a hydrocarbon fraction from cracked gasoline treated with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 6 through C 8 and boiling in the range of approximately 80°C to 135°C.) 649-395-00-7 309-870-9 101316-66-9 P Naphtha (petroleum), hydrodesulphurised full-range coker; low boiling point naphtha – unspecified 649-396-00-2 309-879-8 101316-76-1 P

711. 30.12.2006 EN Official Journal of the European Union L 396/711 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by fractionation from hydrodesulphurised coker distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 5 to C 11 and boiling in the range of approximately 23°C to 196°C.) Naphtha (petroleum), sweetened light; low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 5 through C 8 and boiling in the range of approximately 20°C to 130°C.) 649-397-00-8 309-976-5 101795-01-1 P Hydrocarbons, C 3-6 , C 5 -rich, steam-cracked naphtha; low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained by distillation of steam-cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C 3 through C 6 , predominantly C 5 .) 649-398-00-3 310-012-0 102110-14-5 P

713. 30.12.2006 EN Official Journal of the European Union L 396/713 Substances Index number EC number CAS number Notes Distillates (petroleum), light catalytic cracked; Cracked gas oil (A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 9 through C 25 and boiling in the range of approximately 150°C to 400°C. It contains a relatively large proportion of bicyclic aromatic hydrocarbons.) 649-435-00-3 265-060-4 64741-59-9 Distillates (petroleum), intermediate catalytic cracked; Cracked gas oil (A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 11 through C 30 and boiling in the range of approximately 205°C to 450°C. It contains a relatively large proportion of tricyclic aromatic hydrocarbons.) 649-436-00-9 265-062-5 64741-60-2

714. L 396/714 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (petroleum), light thermal cracked; Cracked gas oil (A complex combination of hydrocarbons from th e distillation of the products from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C 10 through C 22 and boiling in the range of approximately 160°C to 370°C.) 649-438-00-X 265-084-5 64741-82-8 Distillates (petroleum), hydrodesulphurised light catalytic cracked; Cracked gas oil (A complex combination of hydrocarbons obtained by treating light catalytic cracked distillates with hydrogen to convert organic sulphur to hydrogen sulphide which is removed. It consists of hydrocarbons having carbon numbers predominantly in the range of C 9 through C 25 and boiling in the range of approximately 150°C to 400°C. It contains a relative ly large proportion of bicyclic aromatic hydrocarbons.) 649-439-00-5 269-781-5 68333-25-5

715. 30.12.2006 EN Official Journal of the European Union L 396/715 Substances Index number EC number CAS number Notes Distillates (petroleum), light steam-cracked naphtha; Cracked gas oil (A complex combination of hydrocarbons from the multiple distillation of products from a steam cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 10 through C 18 .) 649-440-00-0 270-662-5 68475-80-9 Distillates (petroleum), cracked steam-cracked petroleum distillates; Cracked gas oil (A complex combination of hydrocarbons produced by distilling cracked steam cracked distillate and/or its fracti onation products. It consists of hydrocarbons having carbon numbers predominantly in the range of C 10 to low molecular weight polymers.) 649-441-00-6 270-727-8 68477-38-3 Gas oils (petroleum), steam-cracked; Cracked gas oil (A complex combination of hydrocarbons produced by distillation of the products from a steam cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C 9 and boiling in the range of from approximately 205°C to 400°C.) 649-442-00-1 271-260-2 68527-18-4

716. L 396/716 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (petroleum), hydrodesulphurised thermal cracked middle; Cracked gas oil (A complex combination of hydrocarbons obtained by fractionation from hydrodesulphurised thermal cracker distillate stocks. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 11 to C 25 and boiling in the range of from approximately 205°C to 400°C.) 649-443-00-7 285-505-6 85116-53-6 Gas oils (petroleum), thermal-cracked, hydrodesulphurised; Cracked gas oil 649-444-00-2 295-411-7 92045-29-9 Residues (petroleum), hydrogenated steam-cracked naphtha; Cracked gas oil 649-445-00-8 295-514-7 92062-00-5 (A complex combination of hydrocarbons obtained as a residual fraction from the distillation of hydrotreated steam-cracked naphtha. It consists predominantly of hydrocarbons boiling in the range of approximately 200°C to 350°C.)

717. 30.12.2006 EN Official Journal of the European Union L 396/717 Substances Index number EC number CAS number Notes Residues (petroleum), steam-cracked naphtha distillation; Cracked gas oil (A complex combination of hydrocarbons obtained as a column bottom from the separation of effluents from steam cracking naphtha at a high temp erature. It boils in the range of approximately 147°C to 300°C and produces a finished oil having a viscosity of 18 10 -6 m².s -1 at 50°C.) 649-446-00-3 295-517-3 92062-04-9 Distillates (petroleum), light catalytic cracked, thermally degraded; Cracked gas oil (A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process which has been used as a heat transfer fluid. It consists predominantly of hydrocarbons boiling in the range of approximately 190°C to 340°C. This steam is likely to contain organic sulphur compounds.) 649-447-00-9 295-991-1 92201-60-0 Residues (petroleum), steam-cracked, heat-soaked naphtha; Cracked gas oil (A complex combination of hydrocarbons obtained as residue from the distillation of steam-cracked heat-soaked naphtha and boiling in the range of approximately 150°C to 350°C.) 649-448-00-4 297-905-8 93763-85-0

718. L 396/718 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gas oils (petroleum), light vacuum, thermal-cracked hydrodesulphurised; Cracked gas oil (A complex combination of hydrocarbons obtained by catalytic dehydrosulphurisation of thermal-cracked light vacuum petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 14 through C 20 and boiling in the range of approximately 270°C to 370°C.) 649-450-00-5 308-278-8 97926-59-5 Distillates (petroleum), hydrodesulphurised middle coker; Cracked gas oil (A complex combination of hydrocarbons by fractionation from hydrodesulphurised coker distillate stocks. It consists of hydrocarbons having carbon numbers predominantly in the range of C 12 through C 21 and boiling in the range of approximately 200°C to 360°C.) 649-451-00-0 309-865-1 101316-59-0 Distillates (petroleum), heavy steam-cracked; Cracked gas oil 649-452-00-6 309-939-3 101631-14-5

719. 30.12.2006 EN Official Journal of the European Union L 396/719 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by distillation of steam cracking heavy residues. It consists predominantly of highly alkylated heavy aromatic hydrocarbons boiling in the range of approximately 250°C to 400°C.) Distillates (petroleum), heavy hydrocracked; Base oil – unspecified (A complex combination of hydrocarbons from th e distillation of the products from a hydrocracking process. It consists predominantly of saturated hydrocar bons having carbon numbers in the range of C 15 through C 39 and boiling in the range of approximately 260°C to 600°C.) 649-453-00-1 265-077-7 64741-76-0 L Distillates (petroleum), solvent-refined heavy paraffinic; Base oil – unspecified (A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 and produces a finished oil with a viscosity of at least 19 10 -6 m².s -1 at 40°C.) 649-454-00-7 265-090-8 64741-88-4 L Distillates (petroleum), solvent-refined light paraffinic; Base oil – unspecified 649-455-00-2 265-091-3 64741-89-5 L

720. L 396/720 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 and produces a finished oil having a viscosity of less than 19 10 -6 m².s -1 at 40°C.) Residual oils (petroleum), solvent deasphalted; Base oil – unspecified (A complex combination of hydrocarbons obtained as the solvent soluble fraction from C 3 -C 4 solvent deasphalting of a residuum. It consists of hydrocarbons having carbon numbers predominantly higher than C 25 and boiling above approximately 400°C.) 649-456-00-8 265-096-0 64741-95-3 L Distillates (petroleum), solvent-refined heavy naphthenic; Base oil – unspecified (A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 and produces a finished oil with a viscosity of at least 19 10 -6 m².s -1 at 40°C. It contains relatively few normal paraffins.) 649-457-00-3 265-097-6 64741-96-4 L

721. 30.12.2006 EN Official Journal of the European Union L 396/721 Substances Index number EC number CAS number Notes Distillates (petroleum), solvent-refined light naphthenic; Base oil – unspecified (A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 and produces a finished oil with a viscosity of less than 19 10 -6 m².s -1 at 40°C. It contains relatively few normal paraffins.) 649-458-00-9 265-098-1 64741-97-5 L Residual oils (petroleum), solvent-refined; Base oil – unspecified (A complex combination of hydrocarbons obtained as the solvent insoluble fraction from solvent refining of a residuum using a polar organic solvent such as phenol or furfural. It consists of hydrocarbons having carbon numbers predominantly greater than C 25 and boiling above approximately 400°C.) 649-459-00-4 265-101-6 64742-01-4 L Distillates (petroleum), clay-treated paraffinic; Base oil – unspecified 649-460-00-X 265-137-2 64742-36-5 L

722. L 396/722 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 and produces a finished oil with a viscosity of at least 19 10 -6 m².s -1 at 40°C. It contains a relatively large proportion of saturated hydrocarbons.) Distillates (petroleum), clay-treated light paraffinic; Base oil – unspecified (A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 and produces a finished oil with a viscosity of less than 19 10 -6 m².s -1 at 40°C. It contains a relatively large proportion of saturated hydrocarbons.) 649-461-00-5 265-138-8 64742-37-6 L

723. 30.12.2006 EN Official Journal of the European Union L 396/723 Substances Index number EC number CAS number Notes Residual oils (petroleum), clay-treated; Base oil – unspecified (A complex combination of hydrocarbons obtained by the treatment of a residual oil with a natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly greater than C 25 and boiling above approximately 400°C.) 649-462-00-0 265-143-5 64742-41-2 L Distillates (petroleum), clay-treated heavy naphthenic; Base oil – unspecified (A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with a natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 and produces a finished oil with a viscosity of at least 19 10 -6 m².s -1 at 40°C. It contains relatively few normal paraffins.) 649-463-00-6 265-146-1 64742-44-5 L Distillates (petroleum), clay-treated light naphthenic; Base oil – unspecified 649-464-00-1 265-147-7 64742-45-6 L

724. L 396/724 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 and produces a finished oil with a viscosity of less than 19 10 -6 m².s -1 at 40°C. It contains relatively few normal paraffins.) Distillates (petrole um), hydrotreated heavy naphthenic; Base oil – unspecified (A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 and produces a finished oil with a viscosity of at least 19 10 -6 m².s -1 at 40°C. It contains relatively few normal paraffins.) 649-465-00-7 265-155-0 64742-52-5 L Distillates (petrole um), hydrotreated light naphthenic; Base oil – unspecified 649-466-00-2 265-156-6 64742-53-6 L

725. 30.12.2006 EN Official Journal of the European Union L 396/725 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 and produces a finished oil with a viscosity of less than 19 10 -6 m².s -1 at 40°C. It contains relatively few normal paraffins.) Distillates (petrole um), hydrotreated heavy paraffinic; Base oil – unspecified (A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 and produces a finished oil of at least 19 10 -6 m².s -1 at 40°C. It contains a relatively large proportion of saturated hydrocarbons.) 649-467-00-8 265-157-1 64742-54-7 L Distillates (petrole um), hydrotreated light paraffinic; Base oil – unspecified 649-468-00-3 265-158-7 64742-55-8 L

726. L 396/726 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 and produces a finished oil with a viscosity of less than 19 10 -6 m².s -1 at 40°C. It contains a relatively larg e proportion of saturated hydrocarbons.) Distillates (petroleum), solvent-dewaxed light paraffinic; Base oil – unspecified (A complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallisation. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 and produces a finished oil with a viscosity of less than 19 10 -6 m².s -1 at 40°C.) 649-469-00-9 265-159-2 64742-56-9 L Residual oils (petroleum), hydrotreated; Base oil – unspecified (A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly greater than C 25 and boiling above approximately 400°C.) 649-470-00-4 265-160-8 64742-57-0 L

727. 30.12.2006 EN Official Journal of the European Union L 396/727 Substances Index number EC number CAS number Notes Residual oils (petroleum), solvent-dewaxed; Base oil – unspecified (A complex combination of hydrocarbons obtained by removal of long, branched chain hydrocarbons from a residual oil by solvent crystallisation. It consists of hydrocarbons having carbon numbers predominantly greater than C 25 and boiling above approximately 400°C.) 649-471-00-X 265-166-0 64742-62-7 L Distillates (petroleum), solvent-dewaxed heavy naphthenic; Base oil – unspecified (A complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallisation. It consists of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 and produces a finished oil of not less than 19 10 -6 m².s -1 at 40°C. It contains relatively few normal paraffins.) 649-472-00-5 265-167-6 64742-63-8 L Distillates (petroleum), solvent-dewaxed light naphthenic; Base oil – unspecified 649-473-00-0 265-168-1 64742-64-9 L

728. L 396/728 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallisation. It consists of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 and produces a finished oil with a viscosity of less than 19 10 -6 m².s -1 at 40°C. It contains relatively few normal paraffins.) Distillates (petroleum), solvent-dewaxed heavy paraffinic; Base oil – unspecified (A complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallisation. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 and produces a finished oil with a viscosity of not less than 19 10 -6 m².s -1 at 40°C.) 649-474-00-6 265-169-7 64742-65-0 L Naphthenic oils (petroleum), catalytic dewaxed heavy; Base oil – unspecified 649-475-00-1 265-172-3 64742-68-3 L

729. 30.12.2006 EN Official Journal of the European Union L 396/729 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained from a catalytic dewaxing proc ess. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 and produces a finished oil with a viscosity of at least 19 10 -6 m².s -1 at 40°C. It contains relatively few normal paraffins.) Naphthenic oils (petroleum), catalytic dewaxed light; Base oil – unspecified (A complex combination of hydrocarbons obtained from a catalytic dewaxing proc ess. It consists of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 and produces a finished oil with a viscosity of less than 19 10 -6 m².s -1 at 40°C. It contains relatively few normal paraffins.) 649-476-00-7 265-173-9 64742-69-4 L Paraffin oils (petroleum), catalytic dewaxed heavy; Base oil – unspecified (A complex combination of hydrocarbons obtained from a catalytic dewaxing proc ess. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 and produces a finished oil with a viscosity of at least 19 10 -6 m².s -1 at 40°C.) 649-477-00-2 265-174-4 64742-70-7 L

730. L 396/730 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Paraffin oils (petroleum), catalytic dewaxed light; Base oil – unspecified (A complex combination of hydrocarbons obtained from a catalytic dewaxing proc ess. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 and produces a finished oil with a viscosity of less than 19 10 -6 m².s -1 at 40°C.) 649-478-00-8 265-176-5 64742-71-8 L Naphthenic oils (petroleum), complex dewaxed heavy; Base oil – unspecified (A complex combination of hydrocarbons obtained by removing straight chain paraffin hydrocarbons as a solid by treatment with an agent such as urea. It consists of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 and produces a finished oil with a viscosity of at least 19 10 -6 m².s -1 at 40°C. It contains relatively few normal paraffins.) 649-479-00-3 265-179-1 64742-75-2 L Naphthenic oils (petroleum), complex dewaxed light; Base oil – unspecified 649-480-00-9 265-180-7 64742-76-3 L

731. 30.12.2006 EN Official Journal of the European Union L 396/731 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained from a catalytic dewaxing proc ess. It consists of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 and produces a finished oil having a viscosity less than 19 10 -6 m².s -1 at 40°C. It contains relatively few normal paraffins.) Lubricating oils (petroleum), C 20-50 , hydrotreated neutral oil-based high-viscosity; Base oil – unspecified (A complex combination of hydrocarbons obtained by treating light vacuum gas oil, heavy vacuum gas oil, and solvent deasphalted residual oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two st ages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 and produces a finished oil having a viscosity of approximately 112 10 -6 m².s -1 at 40°C. It contains a relatively large proportion of saturated hydrocarbons.) 649-481-00-4 276-736-3 72623-85-9 L Lubricating oils (petroleum), C 15-30 , hydrotreated neutral oil-based; Base oil – unspecified 649-482-00-X 276-737-9 72623-86-0 L

732. L 396/732 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by treating light vacuum gas oil and heavy vacuum gas oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two st ages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 and produces a finished oil having a viscosity of approximately 15 10 -6 m².s -1 at 40°C. It contains a relatively large proportion of saturated hydrocarbons.) Lubricating oils (petroleum), C 20-50 , hydrotreated neutral oil-based; Base oil – unspecified (A complex combination of hydrocarbons obtained by treating light vacuum gas oil, heavy vacuum gas oil and solvent deasphalted residual oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two st ages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 and produces a finished oil with a viscosity of approximately 32 10 -6 m².s -1 at 40°C. It contains a relatively large proportion of saturated hydrocarbons.) 649-483-00-5 276-738-4 72623-87-1 L

733. 30.12.2006 EN Official Journal of the European Union L 396/733 Substances Index number EC number CAS number Notes Lubricating oils; Base oil – unspecified (A complex combination of hydrocarbons obtained from solvent extraction and dewaxing processes. It consists predominantly of saturated hydrocarbons having carbon numbers in the range of C 15 through C 50 .) 649-484-00-0 278-012-2 74869-22-0 L Distillates (petroleum), complex dewaxed heavy paraffinic; Base oil – unspecified (A complex combination of hydrocarbons obtained by dewaxing heavy paraffinic distill ate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 and produces a finished oil with a viscosity of equal to or greater than 19 10 -6 m².s -1 at 40°C. It contains relatively few normal paraffins.) 649-485-00-6 292-613-7 90640-91-8 L

734. L 396/734 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (petroleum), complex dewaxed light paraffinic; Base oil – unspecified (A complex combination of hydrocarbons obtained by dewaxing light paraffinic distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 12 through C 30 and produces a finished oil with a viscosity of less than 19 10 -6 m².s -1 at 40°C. It contains relatively few normal paraffins.) 649-486-00-1 292-614-2 90640-92-9 L Distillates (petroleum), solvent-dewaxed heavy paraffinic, clay-treated; Base oil – unspecified (A complex combination of hydrocarbons obtained by treating dewaxed heavy paraffinic distillate with neutral or modifi ed clay in either a contacting or percol ation process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 .) 649-487-00-7 292-616-3 90640-94-1 L

735. 30.12.2006 EN Official Journal of the European Union L 396/735 Substances Index number EC number CAS number Notes Hydrocarbons, C 20-50 , solvent-dewaxed heavy paraffinic, hydrotreated; Base oil – unspecified (A complex combination of hydrocarbons produced by treating dewaxed heavy paraffinic distillate with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 .) 649-488-00-2 292-617-9 90640-95-2 L Distillates (petroleum), solvent dewaxed light paraffinic, clay-treated; Base oil – unspecified (A complex combination of hydrocarbons resulting from treatment of dewaxed light paraffinic distillate with na tural or modified clay in either a contacting or percolation process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 .) 649-489-00-8 292-618-4 90640-96-3 L

736. L 396/736 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (petroleum), solvent dewaxed light paraffinic, hydrotreated; Base oil – unspecified (A complex combination of hydrocarbons produced by treating a dewaxed light para ffinic distillate with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 .) 649-490-00-3 292-620-5 90640-97-4 L Residual oils (petroleum), hydrotreated solvent dewaxed; Base oil – unspecified 649-491-00-9 292-656-1 90669-74-2 L Residual oils (petroleum), catalytic dewaxed; Base oil – unspecified 649-492-00-4 294-843-3 91770-57-9 L Distillates (petroleum), dewaxed heavy paraffinic, hydrotreated; Base oil – unspecified (A complex combination of hydrocarbons obtained from an intensive treatment of dewaxed distillate by hydrogenation in the presence of a catalyst. It consists predominantly of saturated hydrocarbons having carbon numbers in the range of C 25 through C 39 and produces a finished oil with a viscosity of approximately 44 10 -6 m².s -1 at 50°C.) 649-493-00-X 295-300-3 91995-39-0 L

737. 30.12.2006 EN Official Journal of the European Union L 396/737 Substances Index number EC number CAS number Notes Distillates (petroleum), dewaxed light paraffinic, hydrotreated; Base oil – unspecified (A complex combination of hydrocarbons obtained from an intensive treatment of dewaxed distillate by hydrogenation in the presence of a catalyst. It consists predominantly of saturated hydrocarbons having carbon numbers in the range of C 21 through C 29 and produces a finished oil with a viscosity of approximately 13 10 -6 m².s -1 at 50°C.) 649-494-00-5 295-301-9 91995-40-3 L Distillates (petroleum), hydrocracked solvent-refined, dewaxed; Base oil – unspecified (A complex combination of liquid hydrocarbons obtained by recrystallisation of dewaxed hydrocracked solvent-refined petroleum distillates.) 649-495-00-0 295-306-6 91995-45-8 L

738. L 396/738 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (petroleum), solvent-refined light naphthenic, hydrotreated; Base oil – unspecified (A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst and removing the aromatic hydrocarbons by solvent extraction. It consists predominantly of naphthenic hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 and produces a finished oil with a viscosity of between 13-15 10 -6 m².s -1 at 40°C.) 649-496-00-6 295-316-0 91995-54-9 L Lubricating oils (petroleum) C 17-35 , solvent-extd., dewaxed, hydrotreated; Base oil – unspecified 649-497-00-1 295-423-2 92045-42-6 L Lubricating oils (petroleum), hydrocracked nonarom. solvent-deparaffined; Base oil – unspecified 649-498-00-7 295-424-8 92045-43-7 L Residual oils (petroleum), hydrocracked acid-treated solvent-dewaxed; Base oil – unspecified (A complex combination of hydrocarbons produced by solvent removal of paraffins from the residue of the distillation of acid-treated, hydrocracked heavy paraffins and boiling approximately above 380°C.) 649-499-00-2 295-499-7 92061-86-4 L

739. 30.12.2006 EN Official Journal of the European Union L 396/739 Substances Index number EC number CAS number Notes Paraffin oils (petroleum), solvent- refined dewaxed heavy; Base oil – unspecified (A complex combination of hydrocarbons obtained from sulphur- containing paraffini c crude oil. It consists predominantly of a solvent refined deparaffinated lubricating oil with a viscosity of 65 10 -6 m².s -1 at 50°C.) 649-500-00-6 295-810-6 92129-09-4 L Lubricating oils (p etroleum), base oils, paraffinic; Base oil – unspecified (A complex combination of hydrocarbons obtained by refining crude oil. It consists predominantly of aromatics, naphthenics and paraffinics and produces a finished oil with a viscosity of 23 10 -6 m².s -1 at 40°C.) 649-501-00-1 297-474-6 93572-43-1 L Hydrocarbons, hydrocracked paraffinic distillation residues, solvent-dewaxed; Base oil – unspecified 649-502-00-7 297-857-8 93763-38-3 L Hydrocarbons, C 20-50 , residual oil hydrogenation vacuum distillate; Base oil – unspecified 649-503-00-2 300-257-1 93924-61-9 L Distillates (petroleum), solvent-refined hydrotreated heavy; hydrogenated; Base oil – unspecified 649-504-00-8 305-588-5 94733-08-1 L

740. L 396/740 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (petroleum), solvent-refined hydrocracked light; Base oil – unspecified (A complex combination of hydrocarbons obtained by solvent dearomatisation of the residue of hydrocracked petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 18 through C 27 and boiling in the range of approximately 370°C to 450°C.) 649-505-00-3 305-589-0 94733-09-2 L Lubricating oils (petroleum), C 18-40 , solvent-dewaxed hydrocracked distillate-based; Base oil – unspecified (A complex combination of hydrocarbons obtained by solvent deparaffination of the distillation residue from hydrocracked petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 18 through C 40 and boiling in the range of approximately 370°C to 550°C.) 649-506-00-9 305-594-8 94733-15-0 L

741. 30.12.2006 EN Official Journal of the European Union L 396/741 Substances Index number EC number CAS number Notes Lubricating oils (petroleum), C 18-40 , solvent-dewaxed hydrogenated raffinate-based; Base oil – unspecified (A complex combination of hydrocarbons obtained by solvent deparaffination of the hydrogenated raffinate obtained by solvent extraction of a hydrotreated petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 18 through C 40 and boiling in the range of approximately 370°C to 550°C.) 649-507-00-4 305-595-3 94733-16-1 L Hydrocarbons, C 13-30 , arom.-rich, solvent-extd. naphthenic distillate; Base oil – unspecified 649-508-00-X 305-971-7 95371-04-3 L Hydrocarbons, C 16-32 , arom.-rich, solvent-extd. naphthenic distillate; Base oil – unspecified 649-509-00-5 305-972-2 95371-05-4 L Hydrocarbons, C 37-68 , dewaxed deasphalted hydrotreated vacuum distillation residues; Base oil – unspecified 649-510-00-0 305-974-3 95371-07-6 L Hydrocarbons, C 37-65 , hydrotreated deasphalted vacuum distillation residues; Base oil – unspecified 649-511-00-6 305-975-9 95371-08-7 L Distillates (petroleum), hydrocracked solvent-refined light; Base oil – unspecified 649-512-00-1 307-010-7 97488-73-8 L

742. L 396/742 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by the solvent treatment of a distillate from hydrocracked petroleu m distillates. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 18 through C 27 and boiling in the range of approximately 370°C to 450°C.) Distillates (petroleum), solvent-refined hydrogenated heavy; Base oil – unspecified (A complex combination of hydrocarbons obtained by the treatment of a hydrogenated petroleum distillate with a solvent. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 19 through C 40 and boiling in the range of approximately 390°C to 550°C.) 649-513-00-7 307-011-2 97488-74-9 L Lubricating oils (petroleum) C 18-27 , hydrocracked solvent-dewaxed; Base oil – unspecified 649-514-00-2 307-034-8 97488-95-4 L Hydrocarbons, C 17-30 , hydrotreated solvent-deasphalted atm. distillation residue, distillation lights; Base oil – unspecified 649-515-00-8 307-661-7 97675-87-1 L

743. 30.12.2006 EN Official Journal of the European Union L 396/743 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the treatment of a solvent deasphalted short residue with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 17 through C 30 and boiling in the range of approximately 300°C to 400°C. It produces a finished oil having a viscosity of 4 10 -6 m².s -1 at approximately 100°C.) Hydrocarbons, C 17-40 , hydrotreated solvent-deasphalted distillation residue, vacuum distillation lights; Base oil – unspecified (A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the catalytic hydrotreatment of a solvent deasphalted short residue having a viscosity of 8 10 -6 m².s -1 at approximately 100°C. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 17 through C 40 and boiling in the range of approximately 300°C to 500°C.) 649-516-00-3 307-755-8 97722-06-0 L Hydrocarbons, C 13-27 , solvent-extd. light naphthenic; Base oil – unspecified 649-517-00-9 307-758-4 97722-09-3 L

744. L 396/744 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by extraction of the aromatics from a light naphthenic distillate having a viscosity of 9.5 10 -6 m².s -1 at 40°C. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 13 through C 27 and boiling in the range of approximately 240°C to 400°C.) Hydrocarbons, C 14-29 , solvent-extd. light naphthenic; Base oil – unspecified (A complex combination of hydrocarbons obtained by extraction of the aromatics from a light naphthenic distillate having a viscosity of 16 10 -6 m².s -1 at 40°C. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 14 through C 29 and boiling in the range of approximately 250°C to 425°C.) 649-518-00-4 307-760-5 97722-10-6 L Hydrocarbons, C 27-42 , dearomatised; Base oil – unspecified 649-519-00-X 308-131-8 97862-81-2 L Hydrocarbons, C 17-30 , hydrotreated distillates, distillation lights; Base oil – unspecified 649-520-00-5 308-132-3 97862-82-3 L Hydrocarbons, C 27-45 , naphthenic vacuum distillation; Base oil – unspecified 649-521-00-0 308-133-9 97862-83-4 L

745. 30.12.2006 EN Official Journal of the European Union L 396/745 Substances Index number EC number CAS number Notes Hydrocarbons, C 27-45 , dearomatised; Base oil – unspecified 649-522-00-6 308-287-7 97926-68-6 L Hydrocarbons, C 20-58 , hydrotreated; Base oil – unspecified 649-523-00-1 308-289-8 97926-70-0 L Hydrocarbons, C 27-42 , naphthenic; Base oil – unspecified 649-524-00-7 308-290-3 97926-71-1 L Residual oils (petroleum), carbon-treated solvent-dewaxed; Base oil – unspecified (A complex combination of hydrocarbons obtained by the treatment of solvent-dewaxed petroleum residual oils with activated charcoal for the removal of trace polar constituents and impurities.) 649-525-00-2 309-710-8 100684-37-5 L Residual oils (petroleum), clay-treated solvent-dewaxed; Base oil – unspecified (A complex combination of hydrocarbons obtained by treatment of solvent-dewaxed petroleum residual oils with bleaching earth for the removal of trace polar constituents and impurities.) 649-526-00-8 309-711-3 100684-38-6 L

746. L 396/746 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Lubricating oils (petroleum) C 25 , solvent-extd., deasphalted, dewaxed, hydrogenated; base oil – unspecified 649-527-00-3 309-874-0 101316-69-2 L (A complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of vacuum distillation residues. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of greater than C 25 and produces a finished oil with a viscosity in the order of 32 10 -6 m².s -1 to 37 10 -6 m².s -1 at 100°C.) Lubricating oils (petroleum) C 17-32 , solvent-extd., dewaxed, hydrogenated; Base oil – unspecified (A complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of atmospheric distilla tion residues. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 17 through C 32 and produces a finished oil with a viscosity in the order 17 10 -6 m².s -1 to 23 10 -6 m².s -1 at 40°C.) 649-528-00-9 309-875-6 101316-70-5 L

747. 30.12.2006 EN Official Journal of the European Union L 396/747 Substances Index number EC number CAS number Notes Lubricating oils (petroleum) C 20-35 , solvent-extd., dewaxed, hydrogenated; Base oil – unspecified (A complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of atmospheric distilla tion residues. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 20 through C 35 and produces a finished oil with a viscosity in the order of 37 10 -6 m².s -1 to 44 10 -6 m².s -1 at 40°C.) 649-529-00-4 309-876-1 101316-71-6 L Lubricating oils (petroleum) C 24-50 , solvent-extd., dewaxed, hydrogenated; Base oil – unspecified (A complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of atmospheric distilla tion residues. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 24 through C 50 and produces a finished oil with a viscosity in the order of 16 10 -6 m².s -1 to 75 10 -6 m².s -1 at 40°C.) 649-530-00-X 309-877-7 101316-72-7 L

748. L 396/748 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Extracts (petroleum), heavy naphthenic distillate solvent, arom. conc.; Distillate aromatic extract (treated) (An aromatic concentrate produced by adding water to heavy naphthenic distillate solvent extract and extraction solvent.) 649-531-00-5 272-175-3 68783-00-6 L Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent; Distillate aromatic extract (treated) (A complex combination of hydrocarbons obtained as the extract from the re-extraction of solvent- refined heavy paraffi nic distillate. It consists of saturated and aromatic hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 .) 649-532-00-0 272-180-0 68783-04-0 L Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted; Distillate aromatic extract (treated) (A complex combination of hydrocarbons obtained as the extract from a solvent extraction of heavy paraffinic distillate.) 649-533-00-6 272-342-0 68814-89-1 L

749. 30.12.2006 EN Official Journal of the European Union L 396/749 Substances Index number EC number CAS number Notes Extracts (petroleum), heavy naphthenic distillate solvent, hydrotreated; Distillate aromatic extract (treated) (A complex combination of hydrocarbons obtained by treating a heavy naphthenic distillate solvent extract with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 and produces a finished oil of at least 19 10 -6 m².s -1 at 40°C.) 649-534-00-1 292-631-5 90641-07-9 L Extracts (petroleum), heavy paraffinic distillate solvent, hydrotreated; Distillate aromatic extract (treated) (A complex combination of hydrocarbons produced by treating a heavy paraffinic distillate solvent extract with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 21 through C 33 and boiling in the range of approximately 350°C to 480°C.) 649-535-00-7 292-632-0 90641-08-0 L

750. L 396/750 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Extracts (petroleum), light paraffinic distillate solvent, hydrotreated; Distillate aromatic extract (treated) (A complex combination of hydrocarbons produced by treating a light paraffinic distillate solvent extract with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 17 through C 26 and boiling in the range of approximately 280°C to 400°C.) 649-536-00-2 292-633-6 90641-09-1 L Extracts (petroleum), hydrotreated paraffinic light distillate solvent; Distillate aromatic extract (treated) (A complex combination of hydrocarbons obtained as the extract from solvent extraction of intermediate paraffinic top solvent distillate that is treated with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 16 through C 36 .) 649-537-00-8 295-335-4 91995-73-2 L Extracts (petroleum), light naphthenic distillate solvent, hydrodesulphurised; Distillate aromatic extract (treated) 649-538-00-3 295-338-0 91995-75-4 L

751. 30.12.2006 EN Official Journal of the European Union L 396/751 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by treating the extract, obtained from a solvent extraction process, with hydrogen in the presence of a catalyst under conditions primarily to remove sulphur compounds. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 . This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.) Extracts (petroleum), light paraffinic distillate solvent, acid-treated; Distillate aromatic extract (treated) (A complex combination of hydrocarbons obtained as a fraction of the distillation of an extract from the solvent extraction of light paraffinic top petroleum distillates that is subjected to a sulphuric acid refining. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 16 through C 32 .) 649-539-00-9 295-339-6 91995-76-5 L Extracts (petroleum), light paraffinic distillate solvent, hydrodesulphurised; Distillate aromatic extract (treated) 649-540-00-4 295-340-1 91995-77-6 L

752. L 396/752 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by solvent extraction of a light paraffin distillate and treated with hydrogen to convert the organic sulphur to hydrogen sulphide which is eliminated. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 40 and produces a finished oil having a viscosity of greater than 10 -5 m².s -1 at 40°C.) Extracts (petroleum), light vacuum gas oil solvent, hydrotreated; Distillate aromatic extract (treated) (A complex combination of hydrocarbons obtained by solvent extraction from light vacuum petroleum gas oils and treated with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 13 through C 30 .) 649-541-00-X 295-342-2 91995-79-8 L Extracts (petroleum), heavy paraffinic distillate solvent, clay-treated; Distillate aromatic extract (treated) 649-542-00-5 296-437-1 92704-08-0 L

753. 30.12.2006 EN Official Journal of the European Union L 396/753 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay in either a contact or percolation process to remove the trace amounts of polar compounds and impurities present. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 . This stream is likely to contain 5 wt. % or more 4-6 membered ring aromatic hydrocarbons.) Extracts (petroleum), heavy naphthenic distillate solvent, hydrodesulphurised; Distillate aromatic extract (treated) (A complex combination of hydrocarbons obtained from a petroleum stock by treating with hydrogen to convert organic sulphur to hydrogen sulphide which is removed. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 15 through C 50 and produces a finished oil with a viscosity of greater than 19 10 -6 m².s -1 at 40°C.) 649-543-00-0 297-827-4 93763-10-1 L Extracts (petroleum), solvent-dewaxed heavy paraffinic distillate solvent, hydrodesulphurised; Distillate aromatic extract (treated) 649-544-00-6 297-829-5 93763-11-2 L

754. L 396/754 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained from a solvent dewaxed petroleum stock by treating with hydrogen to convert organic sulphur to hydrogen sulphide which is removed. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 50 and produces a finished oil with a viscosity of greater than 19 10 -6 m².s -1 at 40°C.) Extracts (petroleum), light paraffinic distillate solvent, carbon-treated; Distillate aromatic extract (treated) (A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillate treated with activated charcoal to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 16 through C 32 .) 649-545-00-1 309-672-2 100684-02-4 L Extracts (petroleum), light paraffinic distillate solvent, clay-treated; Distillate aromatic extract (treated) 649-546-00-7 309-673-8 100684-03-5 L

755. 30.12.2006 EN Official Journal of the European Union L 396/755 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillates treated with bleaching earth to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 16 through C 32 .) Extracts (petroleum), light vacuum, gas oil solvent, carbon-treated; Distillate aromatic extract (treated) (A complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oil treated with activated charcoal for the removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 13 through C 30 .) 649-547-00-2 309-674-3 100684-04-6 L Extracts (petroleum), light vacuum, gas oil solvent, clay-treated; Distillate aromatic extract (treated) 649-548-00-8 309-675-9 100684-05-7 L

758. L 396/758 EN Official Journal of the European Union 30.12.2006 Appendix 4 Point 29 – Mutagens: category 2 Substances Index number EC number CAS number Notes Hexamethylphosphoric triamide; hexamethylphosphoramide 015-106-00-2 211-653-8 680-31-9 Diethyl sulphate 016-027-00-6 200-589-6 64-67-5 Chromium (VI) trioxide 024-001-00-0 215-607-8 1333-82-0 E Potassium dichromate 024-002-00-6 231-906-6 7778-50-9 E Ammonium dichromate 024-003-00-1 232-143-1 7789-09-5 E Sodium dichromate anhydrate 024-004-00-7 234-190-3 10588-01-9 E Sodium dichromate, dihydrate 024-004-01-4 234-190-3 7789-12-0 E Chromyl dichloride; chromic oxychloride 024-005-00-2 239-056-8 14977-61-8 Potassium chromate 024-006-00-8 232-140-5 7789-00-6 Sodium chromate 024-018-00-3 231-889-5 7775-11-3 E Cadmium fluoride 048-006-00-2 232-222-0 7790-79-6 E

761. 30.12.2006 EN Official Journal of the European Union L 396/761 Substances Index number EC number CAS number Notes 1,3,5,-Tris(oxiranylmethyl)- 1,3,5-triazine- 2,4,6(1H,3H,5H)-trione; TGIC 615-021-00-6 219-514-3 2451-62-9 Acrylamide 616-003-00-0 201-173-7 79-06-1 1,3,5-tris-[(2S and 2R)-2,3- epoxypropyl]-1,3,5-triazine- 2,4,6-(1H,3H,5H)-trione 616-091-00-0 423-400-0 59653-74-6 E Gases (petroleum), catalytic cracked naphtha depropaniser overhead, C 3 - rich acid-free; Petroleum gas (A complex combination of hydrocarbons obtained from fractionation of catalytic cracked hydrocarbons and treated to remove acidic impurities. It consists of hydrocarbons having carbon numbers in the range of C 2 through C 4 , predominantly C 3 .) 649-062-00-6 270-755-0 68477-73-6 H, K

762. L 396/762 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gases (petroleum), catalytic cracker; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of the products from a catalytic cracking process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-063-00-1 270-756-6 68477-74-7 H, K Gases (petroleum), catalytic cracker, C 1 - 5 -rich; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of aliphatic hydrocarbons having carbon numbers in the range of C 1 through C 6 , predominantly C 1 through C 5 .) 649-064-00-7 270-757-1 68477-75-8 H, K

763. 30.12.2006 EN Official Journal of the European Union L 396/763 Substances Index number EC number CAS number Notes Gases (petroleum), catalytic polymd. naphtha stabiliser overhead, C 2-4 -rich; Petroleum gas (A complex combination of hydrocarbons obtained from the fractionation stabilisation of catalytic polymerised naphtha. It consists of aliphatic hydrocarbons having carbon numbers in the range of C 2 through C 6 , predominantly C 2 through C 4 .) 649-065-00-2 270-758-7 68477-76-9 H, K Gases (petroleum), catalytic reformer, C 1-4 -rich; Petroleum gas (A complex combination of hydrocarbons produced by distillation of products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers in the range of C 1 through C 6 , predominantly C 1 through C 4 .) 649-066-00-8 270-760-8 68477-79-2 H, K

764. L 396/764 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gases (petroleum), C 3-5 olefinic-paraffinic alkylation feed; Petroleum gas (A complex combination of olefinic and paraffinic hydrocarbons having carbon numbers in the range of C 3 through C 5 which are used as alkylation feed. Ambient temperatures normally exceed the critical temperature of these combinations.) 649-067-00-3 270-765-5 68477-83-8 H, K Gases (petroleum), C 4 -rich; Petroleum gas (A complex combination of hydrocarbons produced by distillation of products from a catalytic fractionation process. It consists of aliphatic hydrocarbons having carbon numbers in the range of C 3 through C 5 , predominantly C 4 .) 649-068-00-9 270-767-6 68477-85-0 H, K

765. 30.12.2006 EN Official Journal of the European Union L 396/765 Substances Index number EC number CAS number Notes Gases (petroleum), deethaniser overheads; Petroleum gas (A complex combination of hydrocarbons produced from distillation of the gas and gasoline fractions from the catalytic cracking process. It contains predominantly ethane and ethylene.) 649-069-00-4 270-768-1 68477-86-1 H, K Gases (petroleum), deisobutaniser tower overheads; Petroleum gas (A complex combination of hydrocarbons produced by the atmospheric distillation of a butane-butylene stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C 3 through C 4 .) 649-070-00-X 270-769-7 68477-87-2 H, K

766. L 396/766 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gases (petroleum), depropaniser dry, propene- rich; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of products from the gas and gasoline fractions of a catalytic cracking process. It consists predominantly of propylene with some ethane and propane.) 649-071-00-5 270-772-3 68477-90-7 H, K Gases (petroleum), depropaniser overheads; Petroleum gas (A complex combination of hydrocarbons produced by distillation of products from the gas and gasoline fractions of a catalytic cracking process. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C 2 through C 4 .) 649-072-00-0 270-773-9 68477-91-8 H, K

767. 30.12.2006 EN Official Journal of the European Union L 396/767 Substances Index number EC number CAS number Notes Gases (petroleum), gas recovery plant depropaniser overheads; Petroleum gas (A complex combination of hydrocarbons obtained by fractionation of miscellaneous hydrocarbon streams. It consists predominantly of hydrocarbons having carbon numbers in the range of C 1 through C 4 , predominantly propane.) 649-073-00-6 270-777-0 68477-94-1 H, K Gases (petroleum), Girbatol unit feed; Petroleum gas (A complex combination of hydrocarbons that is used as the feed into the Girbatol unit to remove hydrogen sulfide. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C 2 through C 4 .) 649-074-00-1 270-778-6 68477-95-2 H, K Gases (petroleum), isomerised naphtha fractionator, C 4 -rich, hydrogen sulfide-free; Petroleum gas 649-075-00-7 270-782-8 68477-99-6 H, K

768. L 396/768 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Tail gas (petroleum), catalytic cracked clarified oil and thermal cracked vacuum residue fractionation reflux drum; Petroleum gas (A complex combination of hydrocarbons obtained from fractionation of catalytic cracked clarified oil and thermal cracked vacuum residue. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-076-00-2 270-802-5 68478-21-7 H, K Tail gas (petroleum), catalytic cracked naphtha stabilisation absorber; Petroleum gas (A complex combination of hydrocarbons obtained from the stabilisation of catalytic cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-077-00-8 270-803-0 68478-22-8 H, K

769. 30.12.2006 EN Official Journal of the European Union L 396/769 Substances Index number EC number CAS number Notes Tail gas (petroleum), catalytic cracker, catalytic reformer and hydrodesulphuriser combined fractionater; Petroleum gas (A complex combination of hydrocarbons obtained from the fractionation of products from catalytic cracking, catalytic reforming and hydrodesulphurising processes treated to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-078-00-3 270-804-6 68478-24-0 H, K

770. L 396/770 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Tail gas (petroleum), catalytic reformed naphtha fractionation stabiliser; Petroleum gas (A complex combination of hydrocarbons obtained from the fractionation stabilisation of catalytic reformed naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-079-00-9 270-806-7 68478-26-2 H, K Tail gas (petroleum), saturate gas plant mixed stream, C 4 -rich; Petroleum gas (A complex combination of hydrocarbons obtained from the fractionation stabilisation of straight-run naphtha, distillation tail gas and catalytic reformed naphtha stabiliser tail gas. It consists of hydrocarbons having carbon numbers in the range of C 3 through C 6 , predominantly butane and isobutane.) 649-080-00-4 270-813-5 68478-32-0 H, K

771. 30.12.2006 EN Official Journal of the European Union L 396/771 Substances Index number EC number CAS number Notes Tail gas (petroleum), saturate gas recovery plant, C 1-2 -rich; Petroleum gas (A complex combination of hydrocarbons obtained from fractionation of distillate tail gas, straight-run naphtha, catalytic reformed naphtha stabiliser tail gas. It consists predominantly of hydrocarbons having carbon numbers in the range of C 1 through C 5 , predominantly methane and ethane.) 649-081-00-X 270-814-0 68478-33-1 H, K Tail gas (petroleum), vacuum residues thermal cracker; Petroleum gas (A complex combination of hydrocarbons obtained from the thermal cracking of vacuum residues. It consists of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-082-00-5 270-815-6 68478-34-2 H, K

772. L 396/772 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Hydrocarbons, C 3-4 -rich, petroleum distillate; Petroleum gas (A complex combination of hydrocarbons produced by distillation and condensation of crude oil. It consists of hydrocarbons having carbon numbers in the range of C 3 through C 5 , predominantly C 3 through C 4 .) 649-083-00-0 270-990-9 68512-91-4 H, K Gases (petroleum), full-range straight-run naphtha dehexaniser off; Petroleum gas (A complex combination of hydrocarbons obtained by the fractionation of the full-range straight-run naphtha. It consists of hydrocarbons having carbon numbers predominantly in the range of C 2 through C 6 .) 649-084-00-6 271-000-8 68513-15-5 H, K

773. 30.12.2006 EN Official Journal of the European Union L 396/773 Substances Index number EC number CAS number Notes Gases (petroleum), hydrocracking depropaniser off, hydrocarbon-rich; Petroleum gas (A complex combination of hydrocarbon produced by the distillation of products from a hydrocracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 . It may also contain small amounts of hydrogen and hydrogen sulfide.) 649-085-00-1 271-001-3 68513-16-6 H, K Gases (petroleum), light straight-run naphtha stabiliser off; Petroleum gas (A complex combination of hydrocarbons obtained by the stabilisation of light straight-run naphtha. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C 2 through C 6 .) 649-086-00-7 271-002-9 68513-17-7 H, K

776. L 396/776 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Hydrocarbons, C 1-4 , debutaniser fraction; Petroleum gas 649-091-00-4 271-261-8 68527-19-5 H, K Gases (petroleum), C 1-5 , wet; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of crude oil and/or the cracking of tower gas oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-092-00-X 271-624-0 68602-83-5 H, K Hydrocarbons, C 2-4 ; Petroleum gas 649-093-00-5 271-734-9 68606-25-7 H, K Hydrocarbons, C 3 ; Petroleum gas 649-094-00-0 271-735-4 68606-26-8 H, K Gases (petroleum), alkylation feed; Petroleum gas (A complex combination of hydrocarbons produced by the catalytic cracking of gas oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C 3 through C 4 .) 649-095-00-6 271-737-5 68606-27-9 H, K

777. 30.12.2006 EN Official Journal of the European Union L 396/777 Substances Index number EC number CAS number Notes Gases (petroleum), depropaniser bottoms fractionation off; Petroleum gas (A complex combination of hydrocarbons obtained from the fractionation of depropaniser bottoms. It consists predominantly of butane, isobutane and butadiene.) 649-096-00-1 271-742-2 68606-34-8 H, K Gases (petroleum), refinery blend; Petroleum gas (A complex combination obtained from various processes. It consists of hydrogen, hydrogen sulfide and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-097-00-7 272-183-7 68783-07-3 H, K

779. 30.12.2006 EN Official Journal of the European Union L 396/779 Substances Index number EC number CAS number Notes Gases (petroleum), crude oil fractionation off; Petroleum gas (A complex combination of hydrocarbons produced by the fractionation of crude oil. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-100-00-1 272-871-7 68918-99-0 H, K Gases (petroleum), dehexaniser off; Petroleum gas (A complex combination of hydrocarbons obtained by the fractionation of combined naphtha streams. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-101-00-7 272-872-2 68919-00-6 H, K

780. L 396/780 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gases (petroleum), light straight run gasoline fractionation stabiliser off; Petroleum gas (A complex combination of hydrocarbons obtained by the fractionation of light straight-run gasoline. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 5 .) 649-102-00-2 272-878-5 68919-05-1 H, K Gases (petroleum), naphtha unifiner desulphurisation stripper off; Petroleum gas (A complex combination of hydrocarbons produced by a naphtha unifiner desulphurisation process and stripped from the naphtha product. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-103-00-8 272-879-0 68919-06-2 H, K

781. 30.12.2006 EN Official Journal of the European Union L 396/781 Substances Index number EC number CAS number Notes Gases (petroleum), straight- run naphtha catalytic reforming off; Petroleum gas (A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha and fractionation of the total effluent. It consists of methane, ethane, and propane.) 649-104-00-3 272-882-7 68919-09-5 H, K Gases (petroleum), fluidised catalytic cracker splitter overheads; Petroleum gas (A complex combination of hydrocarbons produced by the fractionation of the charge to the C 3 -C 4 splitter. It consists predominantly of C 3 hydrocarbons.) 649-105-00-9 272-893-7 68919-20-0 H, K

782. L 396/782 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gases (petroleum), straight- run stabiliser off; Petroleum gas (A complex combination of hydrocarbons obtained from the fractionation of the liquid from the first tower used in the distillation of crude oil. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-106-00-4 272-883-2 68919-10-8 H, K Gases (petroleum), catalytic cracked naphtha debutaniser; Petroleum gas (A complex combination of hydrocarbons obtained from fractionation of catalytic cracked naphtha. It consists of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-107-00-X 273-169-3 68952-76-1 H, K

783. 30.12.2006 EN Official Journal of the European Union L 396/783 Substances Index number EC number CAS number Notes Tail gas (petroleum), catalytic cracked distillate and naphtha stabiliser; Petroleum gas (A complex combination of hydrocarbons obtained by the fractionation of catalytic cracked naphtha and distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-108-00-5 273-170-9 68952-77-2 H, K Tail gas (petroleum), thermal-cracked distillate, gas oil and naphtha absorber; Petroleum gas (A complex combination of hydrocarbons obtained from the separation of thermal- cracked distillates, naphtha and gas oil. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-109-00-0 273-175-6 68952-81-8 H, K

784. L 396/784 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Tail gas (petroleum), thermal cracked hydrocarbon fractionation stabiliser, petroleum coking; Petroleum gas (A complex combination of hydrocarbons obtained from the fractionation stabilisation of thermal cracked hydrocarbons from a petroleum coking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-110-00-6 273-176-1 68952-82-9 H, K Gases (petroleum, light steam-cracked, butadiene conc.; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists of hydrocarbons having a carbon number predominantly of C 4 .) 649-111-00-1 273-265-5 68955-28-2 H, K

829. 30.12.2006 EN Official Journal of the European Union L 396/829 Appendix 5 Point 30 – Toxic to reproduction: category 1 Substances Index number EC number CAS number Notes Carbon monoxide 006-001-00-2 211-128-3 630-08-0 Lead hexafluorosilicate 009-014-00-1 247-278-1 25808-74-6 Lead compounds with the exception of those specified elsewhere in this Annex 082-001-00-6 A, E Lead alkyls 082-002-00-1 A, E Lead azide 082-003-00-7 236-542-1 13424-46-9 Lead chromate 082-004-00-2 231-846-0 7758-97-6 Lead di(acetate) 082-005-00-8 206-104-4 301-04-2 Trilead bis(orthophosphate) 082-006-00-3 231-205-5 7446-27-7 Lead acetate 082-007-00-9 215-630-3 1335-32-6 Lead(II) methanesulphonate 082-008-00-4 401-750-5 17570-76-2 C.I. Pigment Yellow 34; (This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77603.) 082-009-00-X 215-693-7 1344-37-2

830. L 396/830 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes C.I. Pigment Red 104; (This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77605.) 082-010-00-5 235-759-9 12656-85-8 Lead hydrogen arsenate 082-011-00-0 232-064-2 7784-40-9 1,2-Dibromo-3-chloropropane 602-021-00-6 202-479-3 96-12-8 2-bromopropane 602-085-00-5 200-855-1 75-26-3 E Warfarin; 4-hydroxy-3-(3-oxo-1- phenylbutyl)coumarin 607-056-00-0 201-377-6 81-81-2 Lead 2,4,6-trinitroresorcinoxide, lead styphnate 609-019-00-4 239-290-0 15245-44-0

831. 30.12.2006 EN Official Journal of the European Union L 396/831 Appendix 6 Point 30 – Toxic to reproduction: category 2 Substances Index number EC number CAS number Notes Linuron (ISO) 3-(3,4-dichlorophenyl)-1- methoxy-1-methylurea 006-021-00-1 206-356-5 330-55-2 E 6-(2-Chloroethyl)-6(2- methoxyethoxy)-2,5,7,10- tetraoxa-6-silaundecane; etacelasil 014-014-00-X 253-704-7 37894-46-5 Flusilazole (ISO); bis(4- fluorophenyl)-(methyl)- (1H-1,2,4-triazol-1- ylmethyl)-silane 014-017-00-6 – 85509-19-9 E A mixture of: 4-[[bis-(4- fluorophenyl)- methylsilyl]methyl]-4H- 1,2,4-triazole; 1-[[bis-(4- fluorophenyl)methyl- silyl]methyl]-1H-1,2,4- triazole 014-019-00-7 403-250-2 – E

833. 30.12.2006 EN Official Journal of the European Union L 396/833 Substances Index number EC number CAS number Notes 2-Ethoxyethanol; ethylene glycol monoethyl ether; ethylglycol 603-012-00-X 203-804-1 110-80-5 1,2-Dimethoxyethane ethylene glycol dimethyl ether EGDME 603-031-00-3 203-794-9 110-71-4 2,3-Epoxypropan-1-ol; glycidol oxiranemethanol 603-063-00-8 209-128-3 556-52-5 E 2-Methoxypropanol 603-106-00-0 216-455-5 1589-47-5 Bis(2-methoxyethyl) ether 603-139-00-0 203-924-4 111-96-6 R-2,3-epoxy-1-propanol 603- 143-002 404-660-4 57044-25-4 E 1,2-Bis(2- methoxyethoxy)ethane TEGDME; Triethylene glycol dimethyl ether; Triglyme 603-176-00-2 203-977-3 112-49-2 4,4'- isobutylethylidenediphenol; 2,2-bis (4'-hydroxyphenyl)- 4-methylpentane 604-024-00-8 401-720-1 6807-17-6 Tetrahydrothiopyran-3- carboxaldehyde 606-062-00-0 407-330-8 61571-06-0

834. L 396/834 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes 2-Methoxyethyl acetate; ethylene glycol monomethyl ether acetate; methylglycol acetate 607-036-00-1 203-772-9 110-49-6 2-Ethoxyethyl acetate; ethylene glycol monoethyl ether acetate; ethylglycol acetate 607-037-00-7 203-839-2 111-15-9 2-Ethylhexyl 3,5-bis(1,1- dimethylethyl)-4- hydroxyphenyl methyl thio acetate 607-203-00-9 279-452-8 80387-97-9 Bis(2-Methoxyethyl) phthalate 607-228-00-5 204-212-6 117-82-8 2-Methoxypropyl acetate 607-251-00-0 274-724-2 70657-70-4 Fluazifop-butyl (ISO); butyl (RS)-2-[4-(5- trifluoromethyl-2- pyridyloxy)phenoxy]propio nate 607-304-00-8 274-125-6 69806-50-4

837. 30.12.2006 EN Official Journal of the European Union L 396/837 Substances Index number EC number CAS number Notes Nitrofen (ISO); 2,4 dichlorophenyl 4- nitrophenyl ether 609-040-00-9 217-406-0 1836-75-5 Methyl-ONN-azoxymethyl acetate; methyl azoxy methyl acetate 611-004-00-2 209-765-7 592-62-1 2-[2-hydroxy-3-(2- chlorophenyl)carbamoyl-1- naphthylazo]-7-[2-hydroxy- 3-(3- methylphenyl)carbamoyl-1- naphthylazo]fluoren-9-one 611-131-00-3 420-580-2 — Azafenidin 611-140-00-2 — 68049-83-2 Tridemorph (ISO); 2,6- dimethyl-4- tridecylmorpholine 613-020-00-5 246-347-3 24602-86-6 Ethylene thiourea; imidazolidine-2-thione; 2- imidazoline-2-thiol 613-039-00-9 202-506-9 96-45-7 Carbendazim (ISO) methyl benzimidazol-2- ylcarbamate 613-048-00-8 234-232-0 10605-21-7 Benomyl (ISO) methyl 1- (butylcarbamoyl)benzimida zol-2-ylcarbamate 613-049-00-3 241-775-7 17804-35-2

838. L 396/838 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Cycloheximide 613-140-00-8 200-636-0 66-81-9 Flumioxazin (ISO); N-(7- Fluoro-3,4-dihydro-3-oxo- 4-prop-2-ynyl-2H-1,4- benzoxazin-6-yl)cyclohex- 1-ene-1,2-dicarboxamide 613-166-00-X – 103361-09-7 (2RS,3RS)-3-(2- Chlorophenyl)-2-(4- fluorophenyl)-[(1H-1,2,4- triazol-1-yl)-methyl]oxirane 613-175-00-9 406-850-2 106325-08-0 3-Ethyl-2-methyl-2-(3- methylbutyl)-1,3- oxazolidine 613-191-00-6 421-150-7 143860-04-2 A mixture of: 1,3,5-tris(3- aminomethylphenyl)-1,3,5- (1H,3H,5H)-triazine-2,4,6- trione; a mixture of oligomers of 3,5-bis(3- aminomethylphenyl)-1- poly[3,5-bis(3- aminomethylphenyl)-2,4,6- trioxo-1,3,5-(1H,3H,5H)- triazin-1-yl]-1,3,5- (1H,3H,5H)-triazine-2,4,6- trione 613-199-00-X 421-550-1 —

839. 30.12.2006 EN Official Journal of the European Union L 396/839 Substances Index number EC number CAS number Notes N,N-dimethylformamide; dimethyl formamide 616-001-00-X 200-679-5 68-12-2 N, N-Dimethylacetamide 616-011-00-4 204-826-4 127-19-5 E Formamide 616-052-00-8 200-842-0 75-12-7 N-methylacetamide 616-053-00-3 201-182-6 79-16-3 N-methylformamide 616-056-00-X 204-624-6 123-39-7 E

840. L 396/840 EN Official Journal of the European Union 30.12.2006 Appendix 7 Special provisions on the labelling of articles cont aining asbestos 1. All articles containing asbestos or the packaging thereof must bear the label defined as follows: (a) the label conforming to the specimen be low shall be at least 5 cm high (H) and 2,5 cm wide; (b) it shall consist of two parts: – the top part (h 1 = 40 % H) shall include the le tter "a" in white, on a black background, – the bottom part (h 2 = 60 % H) shall include the standard wording in white and/or black, on a red background, a nd shall be clearly legible; (c) if the article contains crocidolite, the wo rds "contains asbestos" used in the standard wording shall be replaced by "cont ains crocidolite/blue asbestos". Member States may exclude from the provision of the first subparagraph articles intended to be placed on the market in thei r territory. The labelling of these articles must however bear the word ing "contains asbestos"; (d) if labelling takes the form of direct printing on the articl es, a single colour contrasting with the backgr ound colour is sufficient.

841. 30.12.2006 EN Official Journal of the European Union L 396/841 2. The label mentioned in this Appendix shall be affixed in accordance with the following rules: (a) on each of the smallest units supplied; (b) if an article has asbestos-based component s, it is sufficient for these components only to bear the label. The labelling may be dispensed with if sm allness of size or unsuitability of packaging make it impossible for a label to be affixed to the component.

842. L 396/842 EN Official Journal of the European Union 30.12.2006 3. Labelling of packaged articles containing asbestos 3.1. The following particulars shall appear on clearly legible and i ndelible labelling on the packaging of packaged articles containing asbestos: (a) the symbol and relevant indications of danger in accordance with this Annex; (b) safety instructions which must be selected in accorda nce with the particulars in this Annex, inasmuch as they are re levant for the particular article. Where additional safety information is provided on the packaging, this shall not weaken or contradict the pa rticulars given in accordan ce with points (a) and (b). 3.2. Labelling in accordance with 3.1 shall be effected by means of: – a label firmly affixed to the packaging, or – a (tie-on) label securely a ttached to the package, or – direct printing of the packaging. 3.3. Articles containing asbestos and which ar e packaged only in loose plastic wrapping or the like shall be regarded as packaged ar ticles and shall be la belled in accordance with 3.2. If articles are separated from such packages and placed on the market unpackaged, each of the smallest units s upplied shall be accompanied by labelling particulars in accordance with 3.1.

843. 30.12.2006 EN Official Journal of the European Union L 396/843 4. Labelling of unpackaged ar ticles containing asbestos For unpackaged articles containing asbest os, labelling in accordance with 3.1 shall be effected by means of: – a label firmly affixed to th e article containing asbestos, – a (tie-on) label securely a ttached to such an article, – direct printing on the articles, or, if the abovementioned is not reasonably practicable as in the case of, for example, smallness of size of the article, the unsuitable nature of the article' s properties or certain technical difficulties by means of a hand- out with labelling in accordance with 3.1. 5. Without prejudice to Community provisions on safety and hygiene at work, the label affixed to the article which may, in the context of its use, be processed or finished, shall be accompanied by any safety instructions which may be appropriate for the article concerned, and in particular by the following: – operate if possible out of doors or in a well-ventilated place, – preferably use hand tools or low-spee d tools equipped, if necessary, with an appropriate dust-extraction fac ility. If high-speed tools are used, they should always be equipped with such a facility,

844. L 396/844 EN Official Journal of the European Union 30.12.2006 – if possible, dampen be fore cutting or drilling, – dampen dust and place it in a properly clos ed receptacle and dispose of it safely. 6. The labelling of any article intended for domestic use whic h is not covered by section 5 and which is likely, during use, to release asbe stos fibres shall, if necessary, contain the following safety instruction: "replace when worn". 7. The labelling of article s containing asbestos shall be in the official language or languages of the Member State(s) where the article is placed on the market.

845. 30.12.2006 EN Official Journal of the European Union L 396/845 Appendix 8 Point 43 – Azocolourants List of aromatic amines CAS number Index number EC number Substances 1 92-67-1 612-072-00-6 202-177-1 biphenyl-4-ylamine 4-aminobiphenyl xenylamine 2 92-87-5 612-042-00-2 202-199-1 benzidine 3 95-69-2 202-441-6 4-chloro-o-toluidine 4 91-59-8 612-022-00-3 202-080-4 2-naphthylamine 5 97-56-3 611-006-00-3 202-591-2 o-aminoazotoluene 4-amino-2',3- dimethylazobenzene 4-o-tolylazo-o-toluidine 6 99-55-8 202-765-8 5-nitro-o-toluidine 7 106-47-8 612-137-00-9 203-401-0 4-chloroaniline 8 615-05-4 210-406-1 4-methoxy-m- phenylenediamine 9 101-77-9 612-051-00-1 202-974-4 4,4'-methylenedianiline 4,4'- diaminodiphenylmethane

846. L 396/846 EN Official Journal of the European Union 30.12.2006 CAS number Index number EC number Substances 10 91-94-1 612-068-00-4 202-109-0 3,3'-dichlorobenzidine 3,3'-dichlorobiphenyl- 4,4'-ylenediamine 11 119-90-4 612-036-00-X 204-355-4 3,3'-dimethoxybenzidine o-dianisidine 12 119-93-7 612-041-00-7 204-358-0 3,3'-dimethylbenzidine 4,4'-bi-o-toluidine 13 838-88-0 612-085-00-7 212-658-8 4,4'-methylenedi-o- toluidine 14 120-71-8 204-419-1 6-methoxy-m-toluidine p-cresidine 15 101-14-4 612-078-00-9 202-918-9 4,4'-methylene-bis-(2- chloro-aniline) 2,2'-dichloro-4,4'- methylene-dianiline 16 101-80-4 202-977-0 4,4'-oxydianiline 17 139-65-1 205-370-9 4,4'-thiodianiline

847. 30.12.2006 EN Official Journal of the European Union L 396/847 CAS number Index number EC number Substances 18 95-53-4 612-091-00-X 202-429-0 o-toluidine 2-aminotoluene 19 95-80-7 612-099-00-3 202-453-1 4-methyl-m- phenylenediamine 20 137-17-7 205-282-0 2,4,5-trimethylaniline 21 90-04-0 612-035-00-4 201-963-1 o-anisidine 2-methoxyaniline 22 60-09-3 611-008-00-4 200-453-6 4-amino azobenzene

848. L 396/848 EN Official Journal of the European Union 30.12.2006 Appendix 9 Point 43 – Azocolourants List of azodyes CAS number Index number EC number Substances 1 Not allocated Component 1: CAS-No: 118685-33-9 C 39 H 23 ClCrN 7 O 12 S. 2Na Component 2: C 46 H 30 CrN 10 O 20 S 2 . 3Na 611-070-00-2 405-665-4 A mixture of: disodium (6-(4-anisidino)-3- sulfonato-2-(3,5-dinitro-2- oxidophenylazo)-1- naphtholato)(1-(5-chloro- 2-oxidophenylazo)-2- naphtholato)chromate(1-); trisodium bis(6-(4- anisidino)-3-s ulfonato-2- (3,5-dinitro-2- oxidophenylazo)-1- naphtholato)chromate(1-)

266. L 396/266 EN Official Journal of the European Union 30.12.2006 C HEMICAL SAFETY REPORT FORMAT 10.2. [Title of Exposure Scenario 2] 10.2.1. Human Health 10.2.1.1. Workers 10.2.1.2. Consumers 10.2.1.3. Indirect exposure to humans via the environment 10.2.2. Environment 10.2.2.1. Aquatic Compartment (incl. Sediment) 10.2.2.2. Terrestrial Compartment 10.2.2.3. Atmospheric Compartment 10.2.2.4. Microbiological Activity in Sewage Treatment Systems [etc.] 10.x. Overall exposure (combined for al l relevant emission/release sources) 10.x.1. Human health (combined for all exposure routes) 10.x.1.1. 10.x.2. Environment (combined for all emission sources) 10.x.2.1.

305. 30.12.2006 EN Official Journal of the European Union L 396/305 5. By-products, unless they are imported or placed on the market themselves. 6. Hydrates of a substance or hydrated ions, form ed by association of a substance with water, provided that the substance has been registered by the manufact urer or importer using this exemption. 7. The following substances which occur in natu re, if they are not chemically modified. Minerals, ores, ore concentrates, cement cli nker, natural gas, liquefied petroleum gas, natural gas condensate, process gases and co mponents thereof, crude oil, coal, coke. 8. Substances occurring in nature other than those listed under paragraph 7, if they are not chemically modified, unless they meet the crit eria for classification as dangerous according to Directive 67/548/EEC. 9. Basic elemental substances for which hazar ds and risks are already well known: hydrogen, oxygen, noble gases (argon, helium, neon, xenon), nitrogen.

308. L 396/308 EN Official Journal of the European Union 30.12.2006 NOTES Note 1: If it is not technically po ssible, or if it does not appear scientifically necessary to give information, the reasons shall be clearly state d, in accordance with the relevant provisions. Note 2: The registrant may wish to declare that certain information submitted in the registration dossier is commercially sensitive and its disclosure might harm him commercially. If this is the case, he shall list the items and provid e a justification. INFORMATION REFERRED TO IN ARTICLE 10(a) (i) TO (v) 1. GENERAL REGISTRANT INFORMATION 1.1. Registrant 1.1.1. Name, address, telephone number, fax number and e-mail address 1.1.2. Contact person 1.1.3. Location of the registrant's production and own use site(s), as appropriate 1.2. Joint submission of data Articles 11 or 19 foresee that parts of the regi stration may be submitted by a lead registrant on behalf of other registrants.

315. 30.12.2006 EN Official Journal of the European Union L 396/315 6.2.2. Environmental exposure (a) water and/or (b) air and/or (c) solid waste and/or (d) soil 6.3. Pattern of exposure: (a) accidental/infrequent and/or (b) occasional and/or (c) continuous/frequent

329. 30.12.2006 EN Official Journal of the European Union L 396/329 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 9.2. Degradation 9.2.1. Biotic 9.2.1.1. Ready biodegradability 9.2.1.1. The study does not need to be conducted if the substance is inorganic. Any other relevant physicochemical, toxico logical and ecotoxicological information that is av ailable shall be provided.

343. 30.12.2006 EN Official Journal of the European Union L 396/343 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 9.2.2. Abiotic 9.2.2.1. Hydrolysis as a function of pH. 9.2.2.1. The study does not need to be conducted if: – the substance is readily biodegradable; or – the substance is highly insoluble in water. 9.3. Fate and behaviour in the environment 9.3.1. Adsorption/desorption screening 9.3.1. The study does not need to be conducted if: – based on the physicochemical properties th e substance can be expected to have a low potential for adsorption (e.g. the subs tance has a low octanol water partition coefficient); or – the substance and its re levant degradation products decompose rapidly.

359. 30.12.2006 EN Official Journal of the European Union L 396/359 10. METHODS OF DETE CTION AND ANALYSIS Description of the analytical methods shall be provided on request, for the relevant compartments for which studies were perfor med using the analytical method concerned. If the analytical methods are not available this sh all be justified.

370. L 396/370 EN Official Journal of the European Union 30.12.2006 10. METHODS OF DETE CTION AND ANALYSIS Description of the analytical methods shall be provided on request, for the relevant compartments for which studies were perfor med using the analytical method concerned. If the analytical methods are not available this sh all be justified.

378. L 396/378 EN Official Journal of the European Union 30.12.2006 2. TESTING IS TECHNICALLY NOT POSSIBLE Testing for a specific endpoint may be omitted, if it is technically not possible to conduct the study as a consequence of the properties of the substance: e.g. ve ry volatile, highly reactive or unstable substances cannot be us ed, mixing of the subs tance with water may cause danger of fire or explosi on or the radio-labelling of th e substance required in certain studies may not be possible. The guidance gi ven in the test methods referred to in Article 13(3), more specifically on the techni cal limitations of a specific method, shall always be respected. 3. SUBSTANCE-TAILORED EXPOSURE-DRIVEN TESTING 3.1. Testing in accordance with sections 8.6 and 8.7 of Annex VIII, Annex IX and Annex X may be omitted, based on the exposure scenar io(s) developed in the Chemical Safety Report. 3.2. In all cases, adequate justif ication and documentation shall be provided. The justification shall be based on an exposure assessment in accordance with section 5 of Annex I and be consistent with the criteria adopted pursuant to section 3.3, and the sp ecific conditions of use must be communicated through the chemical supply chain in accordance with Articles 31 or 32. 3.3. The Commission shall adopt the measures de signed to amend non-essential elements of this Regulation by supplementing it, in accordance with the procedure re ferred to in Article 133(4), to set the criteria defining what cons titutes adequate justif ication under Section 3.2 by 1 December 2008.

382. L 396/382 EN Official Journal of the European Union 30.12.2006 Part A of the Chemical Safety Report shall include a declaration that the risk management measures outlined in the relevant exposure scenarios are implemented by the downstream user for his own uses and that the risk management measures out lined in the exposure scenarios for the identified uses are communicated down the supply chain.

756. L 396/756 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes (A complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oils treated with bleaching earth for removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C 13 through C 30 .) Foots oil (petroleum); Foots oil (A complex combination of hydrocarbons obtained as the oil fraction from a solvent deoiling or a wax sweating process. It consists predominantly of branched chain hydrocarbons having carbon numbers predominantly in the range of C 20 through C 50 .) 649-549-00-3 265-171-8 64742-67-2 L Foots oil (petroleum), hydrotreated; Foots oil 649-550-00-9 295-394-6 92045-12-0 L Refractory ceramic fibres; Special Purpose Fibres, with the exception of those specified elsewhere in Annex I to Directive 67/548/EEC; [Man-made vitreous (silicate) fibres with random orientation with alkaline oxide and alkali earth oxide (Na 2 O + K 2 O + CaO + MgO + BaO) content less or equal to 18 % by weight] 650-017-00-8 R

61. 30.12.2006 EN Official Journal of the European Union L 396/61 38) Use and exposure category: means an e xposure scenario covering a wide range of processes or uses, where the processes or us es are communicated, as a minimum, in terms of the brief general description of use; 39) Substances which occur in nature: mean s a naturally occurrin g substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flota tion, by extraction with water, by steam distillation or by heating solely to remove water, or wh ich is extracted from air by any means; 40) Not chemically modified substance: means a substance whose chemical structure remains unchanged, even if it has undergone a chemical process or treatment, or a physical mineralogical transformation, for instance to remove impurities; 41) Alloy: means a metallic material, homoge nous on a macroscopic scale, consisting of two or more elements so combined that th ey cannot be readily se parated by mechanical means. Article 4 General provision Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his obligations under this Re gulation, appoint a third party representative for all proceedings under Article 11, Article 19, Title III and Article 53 involving discussions with other manufactur ers, importers, or where releva nt downstream users. In these cases, the identity of a manuf acturer or importer or downstr eam user who has appointed a representative shall not normally be disclosed by the Agency to ot her manufacturers, importers, or, where relevant, downstream users.

63. 30.12.2006 EN Official Journal of the European Union L 396/63 3. Any manufacturer or importer of a polymer shall submit a registration to the Agency for the monomer substance(s) or any other substanc e(s), that have not already been registered by an actor up the supply chain, if bo th the following conditions are met: (a) the polymer consists of 2 % weight by weight (w/w) or more of such monomer substance(s) or other substa nce(s) in the form of mono meric units and chemically bound substance(s); (b) the total quantity of such monomer substance(s) or other substance(s) makes up 1 tonne or more per year. 4. A submission for registration shall be accomp anied by the fee required in accordance with Title IX. Article 7 Registration and notification of substances in articles 1. Any producer or importer of articles shall submit a registration to the Agency for any substance contained in those articles, if both the following conditions are met: (a) the substance is present in those articl es in quantities totalling over 1 tonne per producer or importer per year; (b) the substance is intended to be releas ed under normal or reasonably foreseeable conditions of use. A submission for registration shall be accompan ied by the fee required in accordance with Title IX.

66. L 396/66 EN Official Journal of the European Union 30.12.2006 7. From 1 June 2011 paragraphs 2, 3 and 4 of this Article shall a pply 6 months after a substance is identified in accordance with Article 59(1). 8. Any measures for the implementation of paragr aphs 1 to 7 shall be adopted in accordance with the procedure referred to in Article 133(3). Article 8 Only representative of a non-Community manufacturer 1. A natural or legal person established outside the Community who manufactures a substance on its own, in preparations or in ar ticles, formulates a preparation or produces an article that is imported into the Community may by mutual agreement appoint a natural or legal person established in the Community to fulfil, as his only representative, the obligations on importers under this Title. 2. The representative shall also comply with all other obligations of importers under this Regulation. To this end, he shall have a suffi cient background in the practical handling of substances and the information related to th em and, without prejudi ce to Article 36, shall keep available and up-to-date information on qua ntities imported and customers sold to, as well as information on the supply of the latest upd ate of the safety data sheet referred to in Article 31. 3. If a representative is appo inted in accordance with paragr aphs 1 and 2, the non-Community manufacturer shall inform the importer(s) within the same supply chain of the appointment. These importers shall be regard ed as downstream users for the purposes of this Regulation.

67. 30.12.2006 EN Official Journal of the European Union L 396/67 Article 9 Exemption from the general obligation to register for product and process orientated research and development (PPORD) 1. Articles 5, 6, 7, 17, 18 and 21 shall not apply for a period of five years to a substance manufactured in the Community or importe d for the purposes of product and process orientated research and devel opment by a manufacturer or impor ter or producer of articles, by himself or in cooperation with listed custom ers and in a quantity which is limited to the purpose of product and process orientated research and development. 2. For the purpose of paragraph 1, the manufactur er or importer or producer of articles shall notify the Agency of the following information: (a) the identity of the manuf acturer or importer or producer of articles as specified in section 1 of Annex VI; (b) the identity of the substance, as specified in section 2 of Annex VI; (c) the classification of the substance as sp ecified in section 4 of Annex VI, if any; (d) the estimated quantity as specifi ed in section 3.1 of Annex VI; (e) the list of customers referred to in pa ragraph 1, including their names and addresses. The notification shall be accompanied by the f ee required in accordan ce with Title IX. The period set out in paragraph 1 shall begin at receipt of the notific ation at the Agency.

73. 30.12.2006 EN Official Journal of the European Union L 396/73 3. A registrant may submit the information referred to in Article 10(a)(iv) , (vi), (vii) or (ix) separately if: (a) it would be disproportionate ly costly for him to submit this information jointly; or (b) submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or (c) he disagrees with the lead registra nt on the selection of this information. If points (a), (b) or (c) apply, the registra nt shall submit, along with the dossier, an explanation as to why the cost s would be disproportionate, why disclosure of information was likely to lead to substantial commercial detr iment or the nature of the disagreement, as the case may be. 4. A submission for registration shall be accomp anied by the fee required in accordance with Title IX. Article 12 Information to be subm itted depending on tonnage 1. The technical dossier referred to in Article 10(a) shall includ e under points (vi) and (vii) of that provision all physicochemical, toxicological and ecotoxicological information that is relevant and available to the regist rant and as a minimum the following:

83. 30.12.2006 EN Official Journal of the European Union L 396/83 (e) a brief general descriptio n of the use, as specified in section 3.5 of Annex VI; (f) details of the risk mana gement measures applied. Except in cases covered under Article 25(3), Artic le 27(6) or Article 30(3), the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (d) for the purpose of registration. The registration shall be accompanied by the f ee required in accordan ce with Title IX. 3. Paragraph 2 shall apply only to on-site isolat ed intermediates if the manufacturer confirms that the substance is only manufactured and used under strictly c ontrolled conditions in that it is rigorously contained by technical means during its whole lifecycle. Control and procedural technologies shall be used to mi nimise emission and any resulting exposure. If these conditions are not fulfilled, the regist ration shall include the information specified in Article 10. Article 18 Registration of transported isolated intermediates 1. Any manufacturer or importer of a transported isolated in termediate in quantities of 1 tonne or more per year shall submit a regi stration to the Agency for the transported isolated intermediate.

86. L 396/86 EN Official Journal of the European Union 30.12.2006 Article 19 Joint submission of data on isolated intermediates by multiple registrants 1. When an on-site isolated intermediate or tran sported isolated intermediate is intended to be manufactured in the Community by one or mo re manufacturers and/or imported by one or more importers, the following shall apply. Subject to paragraph 2 of this Article, the in formation specified in Article 17(2)(c) and (d) and Article 18(2)(c) and (d) shall first be s ubmitted by one manufacturer or importer acting with the agreement of the ot her assenting manufacturer(s) or importer(s) (hereinafter referred to as "the lead registrant"). Each registrant shall subsequently submit separately the information specified in Article 17(2)(a), (b), (e) and (f) a nd Article 18(2)(a),(b), (e) and (f). 2. A manufacturer or importer may submit the in formation referred to in Article 17(2)(c) or (d) and Article 18(2)(c) or (d) separately if: (a) it would be disproportionately costly for him to submit this jointly; or (b) submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or

90. L 396/90 EN Official Journal of the European Union 30.12.2006 5. An appeal may be brought, in accordance with Articles 91, 92 and 93, against Agency decisions under paragraph 2 of this Article. 6. Where additional information for a particular substance is submitted to the Agency by a new registrant, the Agency shall notify the ex isting registrants that this information is available on the database for the purposes of Article 22. Article 21 Manufacturing and import of substances 1. A registrant may start or c ontinue the manufacture or import of a substance or production or import of an article, if there is no indi cation to the contrary from the Agency in accordance with Article 20(2) w ithin the three weeks after the submission date, without prejudice to Article 27(8). In the case of registrations of phase-in subs tances, such a registrant may continue the manufacture or import of the substance or produc tion or import of an article, if there is no indication to the contra ry from the Agency in accordance with Article 20(2) within the three weeks after the submission date or, if submitted within the two-month period before the relevant deadline of Article 23, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three months from that deadline, without prejudice to Article 27(8).

91. 30.12.2006 EN Official Journal of the European Union L 396/91 In the case of an update of a registration acco rding to Article 22 a registrant may continue the manufacture or import of the substance, or the production or im port of the article, if there is no indication to the c ontrary from the Agency in accordance with Article 20(2) within the three weeks afte r the update date, without pr ejudice to Article 27(8). 2. If the Agency has informed the registrant that he is to submit further information in accordance with the third subpa ragraph of Article 20(2), the registrant may start the manufacture or import of a subs tance or production or import of an article if there is no indication to the contra ry from the Agency within the three weeks after receipt by the Agency of the further information necessary to complete his regist ration, without prejudice to Article 27(8). 3. If a lead registrant submits parts of the registration on behalf of one or more other registrants, as provided for in Articles 11 or 19, any of the other registrants may manufacture or import the substance or produce or import the articles only after the expiry of the time-limit laid down in paragraph 1 or 2 of this Article and pr ovided that there is no indication to the contra ry from the Agency in respect of the registration of the lead registrant acting on behalf of th e others and his own registration. Article 22 Further duties of registrants 1. Following registration, a registrant shall be responsible on his own initiative for updating his registration without undue delay with relevant new info rmation and submitting it to the Agency in the following cases:

95. 30.12.2006 EN Official Journal of the European Union L 396/95 2. Article 5, Article 6, Article 7(1), Article 17, Article 18 and Article 21 shall not apply until 1 June 2013 to phase-in substances manuf actured in the Community or imported, in quantities reaching 100 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007. 3. Article 5, Article 6, Articl e 7(1), Article 17, Article 18 and Article 21 shall not apply until 1 June 2018 to phase-in substances manuf actured in the Community or imported, in quantities reaching 1 tonne or more per year per manufacturer or pe r importer, at least once after 1 June 2007. 4. Without prejudice to paragraphs 1 to 3, a registration can be submitted at any time before the relevant deadline. 5. This Article shall also apply to substances registered under Ar ticle 7 adapted as necessary. Article 24 Notified substances 1. A notification in accordance with Directive 67/ 548/EEC shall be regarded as a registration for the purposes of this Title and the Agen cy shall assign a registration number by 1 December 2008. 2. If the quantity of a notified substance ma nufactured or imported per manufacturer or importer reaches the next tonnage threshol d under Article 12, the additional required information corresponding to that tonnage thre shold, as well as to all the lower tonnage thresholds, shall be submitted in accordan ce with Articles 10 and 12, unless it has already been submitted in accordance with those Articles.

98. L 396/98 EN Official Journal of the European Union 30.12.2006 3. If the same substance has previously been regi stered less than 12 years earlier, the Agency shall inform the potential registrant without delay of the names and addresses of the previous registrant(s) and of the relevant summaries or robust study summaries, as the case may be, already submitted by them. Studies involving vert ebrate animals shall not be repeated. The Agency shall simultaneously inform the pr evious registrants of the name and address of the potential registrant. The available studies shall be shared with th e potential registrant in accordance with Article 27. 4. If several potential re gistrants have made an inquiry in respect of the same substance, the Agency shall inform all potential registrants without delay of the na me and address of the other potential registrants. Article 27 Sharing of existing data in the ca se of registered substances 1. Where a substance has previously been registered less than 12 years earlier as referred to in Article 26(3), the potential registrant: (a) shall, in the case of information invol ving tests on vertebrate animals; and (b) may, in the case of information not involving tests on vertebrate animals, request from the previous registrant(s) th e information he requires with respect to Article 10(a)(vi) and (vii ) in order to register.

111. 30.12.2006 EN Official Journal of the European Union L 396/111 9. Suppliers shall update the sa fety data sheet without dela y on the following occasions: (a) as soon as new information which may aff ect the risk management measures, or new information on hazards becomes available; (b) once an authorisation has been granted or refused; (c) once a restriction has been imposed. The new, dated version of the information, id entified as "Revision: (date)", shall be provided free of charge on pape r or electronically to all form er recipients to whom they have supplied the substance or preparation within the preceding 12 months. Any updates following registration shall incl ude the registration number. Article 32 Duty to communicate information down the supply chain for substances on their own or in preparations for which a safety data sheet is not required 1. Any supplier of a substance on its own or in a preparation who does not have to supply a safety data sheet in accordance with Article 31 shall provide the recipient with the following information: (a) the registration number(s) referred to in Ar ticle 20(3), if availabl e, for any substances for which information is communicated under poi nts (b), (c) or (d) of this paragraph (b) if the substance is subject to authorisati on and details of any authorisation granted or denied under Title VII in this supply chain; (c) details of any restricti on imposed under Title VIII;

119. 30.12.2006 EN Official Journal of the European Union L 396/119 Article 38 Obligation for downstream users to report information 1. Before commencing or continuing with a par ticular use of a subs tance that has been registered by an actor up the supply chai n in accordance with Articles 6 or 18, the downstream user shall report to the Agency the information speci fied in paragraph 2 of this Article, in the following cases: (a) the downstream user has to prepare a ch emical safety report in accordance with Article 37(4); or (b) the downstream user is relying on the exemptions in Article 37(4)(c) or (f). 2. The information reported by the downstr eam user shall include the following: (a) his identity and contact details as specified in sec tion 1.1 of Annex VI; (b) the registration number(s) referred to in Article 20(3), if available; (c) the identity of the subs tance(s) as specified in s ection 2.1 to 2.3.4 of Annex VI; (d) the identity of the manufacturer(s) or th e importer(s) or other supplier as specified in section 1.1 of Annex VI;

120. L 396/120 EN Official Journal of the European Union 30.12.2006 (e) a brief general description of the use(s), as specified in section 3.5 of Annex VI, and of the conditions of use(s); (f) except where the downstream user is rely ing on the exemption in Article 37(4)(c), a proposal for additional testing on vertebrate animals, where this is considered necessary by the downstream user to complete his chemical safety assessment. 3. The downstream user shall update this informa tion without delay in the event of a change in the information reported in accordance with paragraph 1. 4. A downstream user shall repor t to the Agency if his cla ssification of a substance is different to that of his supplier. 5. Except where a downstream user is relying on the exemption in Artic le 37(4)(c), reporting in accordance with paragraphs 1 to 4 of this Article shall not be re quired in respect of a substance, on its own or in a preparation, us ed by the downstream user in quantities of less than 1 tonne per year for that particular use. Article 39 Application of downstream user obligations 1. Downstream users shall be required to comply with the requirements of Article 37 at the latest 12 months after recei ving a registration number co mmunicated to them by their suppliers in a safety data sheet.

123. 30.12.2006 EN Official Journal of the European Union L 396/123 (e) a decision in accordance with points (a), (b) or (c), if several registrants or downstream users of the same substance have submitted proposals for the same test, giving them the opportunity to reach an agreement on who will perform the test on behalf of all of them and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users, as appropriate, to perform the test on behalf of all of them. 4. The registrant or downstream user shall s ubmit the information required to the Agency by the deadline set. Article 41 Compliance check of registrations 1. The Agency may examine any registration in order to verify any of the following: (a) that the information in the technical dossier(s) submitted pursuant to Article 10 complies with the requirement s of Articles 10, 12 and 13 and with Annexes III and VI to X; (b) that the adaptations of the standard information requirements and the related justifications submitted in the technical do ssier(s) comply with the rules governing such adaptations set out in Annexes VII to X and with the general rules set out in Annex XI;

125. 30.12.2006 EN Official Journal of the European Union L 396/125 (a) the dossier contains information in Article 10(a)(iv), (vi) and/or (vii) submitted separately as per Article 11(3); or (b) the dossier is for a substance manufacture d or imported in quantities of 1 tonne or more per year and does not meet the re quirements of Annex VII applying under either Article 12(1)(a) or (b), as the case may be; or (c) the dossier is for a substance listed in the Community rolling action plan referred to in Article 44(2). 6. Any third party may electronical ly submit information to the Agency relating to substances that appear on the list referred to in Artic le 28(4). The Agency shall consider this information together with the informati on submitted according to Article 124 when checking and selecting dossiers. 7. The Commission may, after consulting with the Agency, take a decision to vary the percentage of dossiers selected and amend or include further criteria in paragraph 5 in accordance with the procedure referred to in Article 133(4) Article 42 Check of information submitted and follow-up to dossier evaluation 1. The Agency shall examine any information submitted in consequence of a decision taken under Articles 40 or 41, and draft any appropr iate decisions in accordance with these Articles, if necessary.

126. L 396/126 EN Official Journal of the European Union 30.12.2006 2. Once the dossier evaluation is completed, the Agency shall notify the Commission and the competent authorities of the Member Stat es of the information obtained and any conclusions made. The competent authorities sh all use the information obtained from this evaluation for the purposes of Article 45(5), Article 59(3) and Article 69(4). The Agency shall use the information obtained from this evaluation for the purposes of Article 44. Article 43 Procedure and time periods for exa mination of testing proposals 1. In the case of non phase-in substances, th e Agency shall prepare a draft decision in accordance with Article 40(3) within 180 days of receiving a regist ration or downstream user report containi ng a testing proposal. 2. In the case of phase-in substances, the Ag ency shall prepare the draft decisions in accordance with Article 40(3): (a) by 1 December 2012 for all registrations received by 1 December 2010 containing proposals for testing in order to fulfil th e information requirements in Annexes IX and X; (b) by 1 June 2016 for all registrations r eceived by 1 June 2013 containing proposals for testing in order to fulfil the inform ation requirements in Annex IX only; (c) by 1 June 2022 for any registrations contai ning testing proposals received by 1 June 2018. 3. The list of registration dossier s being evaluated under Article 40 shall be made available to Member States.

128. L 396/128 EN Official Journal of the European Union 30.12.2006 2. The Agency shall use the criteria in para graph 1 for the purpose of compiling a draft Community rolling action plan which shall cover a period of three years and shall specify substances to be evaluated each year. Substan ces shall be included if there are grounds for considering (either on the basis of a dossier evaluation carrie d out by the Agency or on the basis of any other appropriate source, including information in the registration dossier) that a given substance constitutes a risk to human health or the environment. The Agency shall submit the first draft rolling action plan to the Member States by 1 December 2011. The Agency shall submit draft annual updates to th e rolling action plan to the Member States by 28 February each year. The Agency shall adopt the final Community ro lling action plan on the basis of an opinion from the Member State Committee set up under Artic le 76(1)(e) (hereinafter referred to as "the Member State Committee") and shall publish the plan on its website, identifying the Member State who will carry out the evaluati on of the substances listed therein as determined according to Article 45. Article 45 Competent authority 1. The Agency shall be responsible for coor dinating the substance evaluation process and ensuring that substances on the Community roll ing action plan are ev aluated. In doing so, the Agency shall rely on the competent author ities of Member States . In carrying out an evaluation of a substance, the competent au thorities may appoint another body to act on their behalf.

130. L 396/130 EN Official Journal of the European Union 30.12.2006 4. The competent authority identified in accord ance with paragraphs 2 and 3 shall evaluate the allocated substances in accordance with this Chapter. 5. A Member State may notify the Agency at a ny time of a substance not on the Community rolling action plan, whenever it is in possession of inform ation which suggests that the substance is a priority for evaluation. The Agency shall decide whether to add this substance to the Community rolling action pl an on the basis of an opinion from the Member State Committee. If the substance is added to the Community rolling action plan, the proposing Member State, or another Memb er State who agrees, shall evaluate that substance. Article 46 Requests for further information and check of information submitted 1. If the competent authority considers that further information is required, including, if appropriate, information not required in Annexe s VII to X, it shall prepare a draft decision, stating reasons, requiring the registrant(s) to submit the further information and setting a deadline for its submission. A draft decision sh all be prepared within 12 months of the publication of the Community roll ing action plan on the Agency's website for substances to be evaluated that year. The decision shall be taken in accordance with the procedure laid down in Articles 50 and 52. 2. The registrant shall submit the information required to the Agency by the deadline set. 3. The competent authority shall examine any information submitted, and shall draft any appropriate decisions in accordance with this Ar ticle, if necessary, w ithin 12 months of the information being submitted.

131. 30.12.2006 EN Official Journal of the European Union L 396/131 4. The competent authority shall finish its eval uation activities within 12 months of the start of the evaluation of the substance or within 12 months of the information being submitted under paragraph 2, and notify the Agency accord ingly. If this deadline is exceeded, the evaluation shall be deemed to be finished. Article 47 Coherence with other activities 1. An evaluation of a substance shall be based on all relevant information submitted on that particular substance and on any previous eval uation under this Title. Where information on intrinsic properties of a substance has been generated by reference to structurally related substance(s), the evaluation may also cover these related substances. In cases where a decision on an evaluation has been previous ly taken in accordance with Article 51 or Article 52, any draft decision requiring further informati on under Article 46 may be justified only by a change of circumstances or acquired knowledge. 2. In order to ensure a harmonised approach to requests for further information, the Agency shall monitor draft decisions under Article 46 and shall develop criteria and priorities. Where appropriate, implementing measures sh all be adopted in accordance with the procedure referred to in Article 133(3).

137. 30.12.2006 EN Official Journal of the European Union L 396/137 Article 53 Cost sharing for tests without an agreement between registrants and/or downstream users 1. Where registrants or downstream users are re quired to perform a te st as a result of a decision taken under this Title, those regist rants or downstream users shall make every effort to reach an agreement as to who is to carry it out on behalf of the other registrants or downstream users and to inform the Agency acc ordingly within 90 days. If the Agency is not informed of such agreement within su ch 90 days, it shall designate one of the registrants or downstream users to perfor m the test on behalf of all of them. 2. If a registrant or downstream user performs a test on behalf of others , they shall all share the cost of that study equally. 3. In the case referred to in paragraph 1, the registrant or downstream user who performs the test shall provide each of the others concer ned with a copy of the full study report. 4. The person performing and submitting the study shall have a claim against the others accordingly. Any person concerned shall be ab le to make a claim in order to prohibit another person from manufacturing, importing or placing the substance on the market if that other person either fails to pay his share of the cost or to provi de security for that amount or fails to hand over a copy of the full study report of th e study performed. All claims shall be enforceable in the national cour ts. Any person may choose to submit their claims for remuneration to an arbitrati on board and accept the arbitration order.

139. 30.12.2006 EN Official Journal of the European Union L 396/139 Article 56 General provisions 1. A manufacturer, importer or downstream user sh all not place a substance on the market for a use or use it himself if that substan ce is included in Annex XIV, unless: (a) the use(s) of that substan ce on its own or in a preparati on or the incorporation of the substance into an article for which the subs tance is placed on the market or for which he uses the substance himself has been au thorised in accordance with Articles 60 to 64; or (b) the use(s) of that substan ce on its own or in a preparati on or the incorporation of the substance into an article for which the subs tance is placed on the market or for which he uses the substance himself has been ex empted from the authorisation requirement in Annex XIV itself in accordance with Article 58(2); or (c) the date referred to in Article 58(1)(c)(i) has not b een reached; or (d) the date referred to in Article 58(1 )(c)(i) has been reached and he made an application 18 months before that date but a decision on th e application for authorisation has not yet been taken; or (e) in cases where the substance is placed on the market, authorisation for that use has been granted to his immediate downstream user.

141. 30.12.2006 EN Official Journal of the European Union L 396/141 (b) uses in food contact materials within the scope of Regula tion (EC) No 1935/2004. 6. Paragraphs 1 and 2 shall not apply to the use of substances when they are present in preparations: (a) for substances referred to in Article 57( d), (e) and (f), below a concentration limit of 0,1 % weight by weight (w/w); (b) for all other substances, below the lowest of the concentration limits specified in Directive 1999/45/EC or in Annex I to Directive 67/548/EEC which result in the classification of the pr eparation as dangerous. Article 57 Substances to be included in Annex XIV The following substances may be included in A nnex XIV in accordance with the procedure laid down in Article 58: (a) substances meeting the criteria for cla ssification as carcinogeni c category 1 or 2 in accordance with Directive 67/548/EEC; (b) substances meeting the criteria for cla ssification as mutagenic category 1 or 2 in accordance with Directive 67/548/EEC;

143. 30.12.2006 EN Official Journal of the European Union L 396/143 Article 58 Inclusion of substances in Annex XIV 1. Whenever a decision is taken to include in A nnex XIV substances referred to in Article 57, such a decision shall be taken in accord ance with the procedur e referred to in Article 133(4). It shall specify for each substance: (a) the identity of the substance as specified in section 2 of Annex VI; (b) the intrinsic property (pr operties) of the substance referred to in Article 57; (c) transitional arrangements: (i) the date(s) from which the placing on the market and the use of the substance shall be prohibited unless an authorisation is granted (hereinafter referred to as "the sunset date") whic h should take into account, where appropriate, the production cycle specified for that use; (ii) a date or dates at least 18 mont hs before the sunset date(s) by which applications must be received if the applicant wishes to continue to use the substance or place it on the market for cer tain uses after the sunset date(s); these continued uses shall be allowed after the sunset date until a decision on the application for authorisation is taken;

146. L 396/146 EN Official Journal of the European Union 30.12.2006 7. Substances for which all uses have be en prohibited under Title VIII or by other Community legislation shall not be included in Annex XIV or shall be removed from it. 8. Substances which as a result of new inform ation no longer meet the criteria of Article 57 shall be removed from Annex XIV in accord ance with the procedure referred to in Article 133(4). Article 59 Identification of substances referred to in Article 57 1. The procedure set out in paragraphs 2 to 10 of this Article shall apply for the purpose of identifying substances meeting the criteria referred to in Article 57 and establishing a candidate list for eventual incl usion in Annex XIV. The Agency shall indicate, within this list, the substances that are on its work programme according to Article 83(3)(e). 2. The Commission may ask the Agency to prep are a dossier in accordance with relevant sections of Annex XV for substances which in its opinion meet the criteria set out in Article 57. The dossier may be lim ited, if appropriate, to a refe rence to an entry in Annex I of Directive 67/548/EEC. The Agency shall make this dossier available to the Member States.

152. L 396/152 EN Official Journal of the European Union 30.12.2006 (c) the use(s) for which the authorisation is granted; (d) any conditions under which th e authorisation is granted; (e) the time-limited review period; (f) any monitoring arrangement. 10. Notwithstanding any conditions of an authorisation, the holder shall ensure that the exposure is reduced to as low a level as is technically and practically possible. Article 61 Review of authorisations 1. Authorisations granted in accordance with Ar ticle 60 shall be regarded as valid until the Commission decides to amend or withdraw the authorisation in the context of a review, provided that the holder of th e authorisation submits a revi ew report at least 18 months before the expiry of the time-limited review period. Rather than re-submitting all elements of the original application fo r the current authorisation, the holder of an authorisation may submit only the number of the current au thorisation, subject to the second, third and fourth subparagraphs.

165. 30.12.2006 EN Official Journal of the European Union L 396/165 2. For a substance on its own, in a preparation or in an article which meets the criteria for classification as carcinogenic, mutagenic or toxic to reproduction, category 1 or 2, and could be used by consumers and for which rest rictions to consumer use are proposed by the Commission, Annex XVII shall be amended in accordance with the procedure referred to in Article 133(4). Article s 69 to 73 sh all not apply. Article 69 Preparation of a proposal 1. If the Commission considers that the manufact ure, placing on the market or use of a substance on its own, in a preparation or in an article poses a risk to human health or the environment that is not adequately controlled and needs to be addr essed, it shall ask the Agency to prepare a dossier which confor ms to the requirements of Annex XV. 2. After the date referred to in Article 58(1)(c )(i) for a substance listed in Annex XIV, the Agency shall consider whether the use of that substance in articles poses a risk to human health or the environment that is not adequate ly controlled. If the Agency considers that the risk is not adequately controlled, it sh all prepare a dossier which conforms to the requirements of Annex XV. 3. Within 12 months of the rece ipt of the request from the Co mmission in paragraph 1 and if this dossier demonstrates th at action on a Community-wide ba sis is necessary, beyond any measures already in place, the Agency shall s uggest restrictions, in order to initiate the restrictions process.

168. L 396/168 EN Official Journal of the European Union 30.12.2006 6. Without prejudice to Articles 118 and 119, the Ag ency shall make publicly available on its website all dossiers conforming with Annex XV including the restrictions suggested pursuant to paragraphs 3 and 4 of this Articl e without delay, clearly indicating the date of publication. The Agency shall invi te all interested parties to submit individually or jointly within 6 months of the date of publication: (a) comments on dossiers and the suggested restrictions; (b) a socio-economic analysis, or informa tion which can contribute to one, of the suggested restrictions, exam ining the advantages and drawbacks of the proposed restrictions. It shall conform to the requirements in Annex XVI. Article 70 Agency opinion: Committee for Risk Assessment Within nine months of the date of publication referred to in Article 69(6), the Committee for Risk Assessment shall formulate an opinion as to whethe r the suggested restrictions are appropriate in reducing the risk to human health and/or the environment, based on its consideration of the relevant parts of the dossier. This opinion shall take account of the Member State dossier or of the dossier prepared by the Agency at the request of the Commission, and the views of interested parties referred to in point (a) of Article 69(6).

175. 30.12.2006 EN Official Journal of the European Union L 396/175 2. The Committees referred to in points (c), (d) a nd (e) of paragraph 1 (hereinafter referred to as "the Committees") and the Forum may each establish working groups. For this purpose they shall adopt, in accordance with their rules of procedur e, precise arrangements for delegating certain tasks to these working groups. 3. The Committees and the Foru m may, if they consider it appropriate, seek advice on important questions of a general scientific or ethical nature from a ppropriate sources of expertise. Article 77 Tasks 1. The Agency shall provide the Member States and the institutions of the Community with the best possible scientific and technical ad vice on questions relating to chemicals which fall within its remit and which are referred to it in accordance with the provisions of this Regulation. 2. The Secretariat shall undertake the following tasks: (a) performing the tasks allotted to it under Title II; including facilitating the efficient registration of imported substances, in a way consistent with the Community's international trading obligations towards third countries; (b) performing the tasks allotted to it under Title III;

176. L 396/176 EN Official Journal of the European Union 30.12.2006 (c) performing the tasks allotted to it under Title VI; (d) performing the tasks allotte d to it under Title VIII; (e) establishing and maintaining database(s) with information on all registered substances, the classification and la belling inventory and the harmonised classification and labelling list. It sha ll make the information identified in Article 119(1) and (2) in the database(s) pub licly available, free of charge, over the Internet, except where a request made under Article 10(a)(xi) is considered justified. The Agency shall make other information in the databases available on request in accordance with Article 118; (f) making publicly available information as to which substances are being, and have been evaluated within 90 days of receip t of the information at the Agency, in accordance with Article 119(1); (g) providing technical and sc ientific guidance and tools where appropriate for the operation of this Regulation in particular to assist the development of chemical safety reports (in accordance with Article 1 4, Article 31(1) and Article 37(4)) and application of Article 10(a )(viii), Article 11(3) and Ar ticle 19(2) by industry and especially by SMEs; and technical and sc ientific guidance for the application of Article 7 by producers and im porters of articles; (h) providing technical and sc ientific guidance on the opera tion of this Regulation for Member State competent authorities a nd providing support to the helpdesks established by Member States under Title XIII;

180. L 396/180 EN Official Journal of the European Union 30.12.2006 It shall exercise disciplinary au thority over the Executive Director. It shall adopt its ru les of procedure. It shall appoint the Chairman, the members and al ternates of the Board of Appeal in accordance with Article 89. It shall appoint the member s of the Agency committees as set out in Article 85. It shall forward annually any information relevant to the outcome of the evaluation procedures in accordance with Article 96(6). Article 79 Composition of the Management Board 1. The Management Board shall be composed of one representative from each Member State and a maximum of six representatives appointed by the Commission, including three individuals from interested parties without voting rights and in a ddition two independent persons appointed by the European Parliament. Each Member State shall nominate a member to the Management Board. The members thus nominated shall be appointed by the Council. 2. Members shall be appointed on the basis of th eir relevant experience and expertise in the field of chemical safety or the regulation of chemicals whilst ensuring there is relevant expertise amongst the board members in the fields of general, financia l and legal matters.

185. 30.12.2006 EN Official Journal of the European Union L 396/185 Article 84 Appointment of the Executive Director 1. The Executive Director of the Agency shal l be appointed by the Management Board on the basis of a list of candidates proposed by th e Commission following a call for expressions of interest published in the O fficial Journal of the European Union and in other periodicals or on Internet sites. The Executive Director shall be appoin ted on the grounds of merit and documented administrative and management skills, as well as his relevant experien ce in the fields of chemical safety or regulation. The Manage ment Board shall take its decision by a two-thirds majority of all members with a right to vote. Power to dismiss the Executive Director sh all lie with the Management Board, in accordance with the same procedure. Before being appointed, the candidate selected by the Management Board shall be invited as soon as possible to make a statement befo re the European Parliament and to answer questions from Members of Parliament. 2. The term of the office of the Executive Director shall be five 5 year s. It may be prolonged by the Management Board once for another period of up to five years.

186. L 396/186 EN Official Journal of the European Union 30.12.2006 Article 85 Establishment of the Committees 1. Each Member State may nominate candidate s to membership of the Committee for Risk Assessment. The Executive Director shall esta blish a list of the nominees, which shall be published on the Agency's website, without prejudice to Article 88(1). The Management Board shall appoint the members of the Committ ee from this list, including at least one member but not more than two from the nominees of each Member State that has nominated candidates. Members shall be appointed for thei r role and experience in performing the tasks specif ied in Article 77(3). 2. Each Member State may nominate candida tes to membership of the Committee for Socio-economic Analysis. The Executive Direct or shall establish a list of the nominees, which shall be published on the Agency's website , without prejudice to Article 88(1). The Management Board shall appoint the members of the Committee from this list, including at least one member but not more than two from the nominees of each Member State that has nominated candidates. Members shall be a ppointed for their role and experience in performing the tasks specif ied in Article 77(3). 3. Each Member State shall appoint one member to the Member State Committee. 4. The Committees shall aim to have a broa d range of relevant expertise among their members. To this end each Committee may co -opt a maximum of five additional members chosen on the basis of their specific competence.

190. L 396/190 EN Official Journal of the European Union 30.12.2006 Article 87 Rapporteurs of Committees and use of experts 1. Where, in accordance with Article 77, a Co mmittee is required to provide an opinion or consider whether a Member State dossier conf orms with the requirements of Annex XV, it shall appoint one of its members as a rappor teur. The Committee c oncerned may appoint a second member to act as co-rapporteur. For each case, rapporteurs and co-rapporteurs shall undertake to act in th e interests of the Community a nd shall make a declaration of commitment to fulfil their duties and a declarat ion of interests in wr iting. A member of a Committee shall not be appointed rapporteur for a particular case if he indicates any interest that might be prejudi cial to the independent cons ideration of that case. The Committee concerned may replace the rapporteur or co-rapporteur by another one of its members at any time, if, for example, they ar e unable to fulfil their duties within the prescribed time limits, or if a potentia lly prejudicial intere st comes to light. 2. Member States shall transmit to the Agency the names of experts with proven experience in the tasks required by Article 77, who would be available to serve on working groups of the Committees, together with an indication of their qualifications a nd specific areas of expertise. The Agency shall keep an up-to-date list of experts. The list shall include the experts referred to in the first subparagr aph and other experts identified directly by the Secretariat.

193. 30.12.2006 EN Official Journal of the European Union L 396/193 2. The Chairman and the two members shall have alternates who shall re present them in their absence. 3. The Chairman, the other members and the alternates shall be appointed by the Management Board on the basis of a list of candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and in other periodicals or on Internet sites. They shall be appointed on the basis of their relevant experience and exper tise in the field of chemical safety, natural sciences or regulatory and judi cial procedures from a list of qualified candidates adopted by the Commission. The Management Board may appoint add itional members and their alternates, on recommendation by the Executive Director, follo wing the same procedure, if this is necessary to ensure that the appeals can be processed at a satisfactory rate. 4. The qualifications required for the members of the Board of Appeal shall be determined by the Commission in accordance with the pro cedure referred to in Article 133(3). 5. The Chairman and the members shall have equal voting rights. Article 90 Members of the Board of Appeal 1. The term of office of the members of the Bo ard of Appeal, including the Chairman and the alternates shall be five year s. It may be prolonged once.

197. 30.12.2006 EN Official Journal of the European Union L 396/197 2. Should the Agency fail to take a decision, pr oceedings for failure to act may be brought before the Court of First Instance or the Cour t of Justice in accordan ce with Article 232 of the Treaty. 3. The Agency shall be required to take the n ecessary measures to comply with the judgment of the Court of First Instan ce or the Court of Justice. Article 95 Conflicts of opinion with other bodies 1. The Agency shall take care to ensure early identification of potential sources of conflict between its opinions and those of other bodies established under Community law, including Community Agencies, ca rrying out a similar task in relation to issues of common concern. 2. Where the Agency identifies a potential source of conflict, it shall contact the body concerned in order to ensure th at any relevant scientific or technical information is shared and to identify the scientific or techni cal points which are potentially contentious. 3. Where there is a fundamental conflict over scientific or techni cal points and the body concerned is a Community Agency or a scie ntific committee, the Agency and the body concerned shall work together either to solv e the conflict or to submit a joint document to the Commission clarifying the scientific and/or technical points of conflict.

198. L 396/198 EN Official Journal of the European Union 30.12.2006 Article 96 The budget of the Agency 1. The revenues of the Ag ency shall consist of: (a) a subsidy from the Community, entered in the general budget of the European Communities (Commission Section); (b) the fees paid by undertakings; (c) any voluntary contribution from the Member States. 2. The expenditure of the Agency shall include the staff, administrative, infrastructure and operational expenses. 3. By 15 February of each year at the late st, the Executive Director shall draw up a preliminary draft budget covering the operationa l expenditure and the programme of work anticipated for the following financial year, and shall forward this preliminary draft to the Management Board together with an estab lishment plan accompanied by a provisional list of posts. 4. Revenue and expenditure shall be in balance. 5. Each year the Management Board, on th e basis of a draft drawn up by the Executive Director, shall produce an estimate of reve nue and expenditure for the Agency for the following financial year. This estimate, whic h shall include a draft establishment plan, shall be forwarded by the Management Board to the Commission by 31 March at the latest.

200. L 396/200 EN Official Journal of the European Union 30.12.2006 Article 97 Implementation of the budget of the Agency 1. The Executive Director shall perform the dutie s of authorising officer and shall implement the Agency's budget. 2. Monitoring of the commitment and payment of all the Agency's expenditure and of the establishment and recovery of all the Agen cy's revenue shall be carried out by the Accounting Officer of the Agency. 3. By 1 March at the latest following each fi nancial year, the Agency's accounting officer shall communicate the provisional account s to the Commission's accounting officer together with a report on the budgetary and fi nancial management for that financial year. The Commission's accounting officer shall cons olidate the provisional accounts of the institutions and decentralised bodie s in accordance with Article 128 of Regulation (EC, Euratom) No 1605/2002. 4. By 31 March at the latest following each financial year, the Commission's accounting officer shall forward the Agency's provisional accounts to the Court of Auditors, together with a report on the budg etary and financial management fo r that financial year. The report on the budgetary and financial management for th at financial year shall also be forwarded to the European Parlia ment and the Council.

207. 30.12.2006 EN Official Journal of the European Union L 396/207 Article 110 Relations with relevant Community bodies 1. The Agency shall cooperate with other Comm unity bodies to ensure mutual support in the accomplishment of their respective tasks in particular to avoid duplication of work. 2. The Executive Director, having consulted the Committee on Risk Assessment and the European Food Safety Authority, shall establis h rules of procedure concerning substances for which an opinion has been sought in a food safety context. These rules of procedure shall be adopted by the Management Board, in agreement with the Commission. This Title shall not otherwise affect the competences vested in the European Food Safety Authority. 3. This Title shall not affect the competences vested in the European Medicines Agency. 4. The Executive Director, having consulte d the Committee on Risk Assessment, the Committee on Socio-economic Analysis and th e Advisory Committee on Safety, Hygiene and Health Protection at Work, shall estab lish rules of procedure concerning worker protection issues. These rules of procedure shall be adopted by the Management Board, in agreement with the Commission. This Title shall not affect the competences vested in the Advisory Committee on Safety, Hygiene and Health Protection at Work and the European Agency for Health and Safety at Work.

211. 30.12.2006 EN Official Journal of the European Union L 396/211 Article 114 Classification and labelling inventory 1. A classification and labe lling inventory, listing the in formation referred to in Article 113(1), both for information notified under Article 113(1) as well as for information submitted as part of a registration, shall be established and maintained by the Agency in the form of a database. The information in this database identified in Article 119(1) shall be publicly accessible. The Agency shall gr ant access to the other data on each substance in the inventory to the not ifiers and registrants who have submitted information on that substance in accordance with Article 29(1). The Agency shall update the inventory when it receives updated information in accordance with Article 113(3). 2. In addition to the information referred to in paragraph 1, the Agency shall record the following information, where appropriate, against each entry: (a) whether, in respect of the entry, there is a harmonised classification and labelling at Community level by inclusion in Annex I of Directive 67/548/EEC; (b) whether, in respect of the entry, it is a joint entry between registrants of the same substance as per Article 11(1); (c) if the entry differs from another entr y on the inventory for the same substance; (d) the relevant registration number(s), if available.

214. L 396/214 EN Official Journal of the European Union 30.12.2006 4. Every five years, the Commission shall publish a general report on (a) the experience acquired w ith the operation of this Regulation, including the information referred to in paragraphs 1, 2 and 3 and (b) the amount and distribution of funding made available by the Commission for the development and evaluation of alternative test methods. The first report shall be published by 1 June 2012. Article 118 Access to information 1. Regulation (EC) No 1049/ 2001 shall apply to documents held by the Agency. 2. Disclosure of the following information shall normally be deemed to undermine the protection of the commercial inte rests of the concerned person: (a) details of the full comp osition of a preparation; (b) without prejudice to Article 7(6) and Ar ticle 64(2), the precise use, function or application of a substance or preparation, including inform ation about its precise use as an intermediate; (c) the precise tonnage of the substance or preparation manufactured or placed on the market;

215. 30.12.2006 EN Official Journal of the European Union L 396/215 (d) links between a manufacturer or importe r and his distributors or downstream users. Where urgent action is essentia l to protect human health, safety or the environment, such as emergency situations, the Agency may disc lose the information referred to in this paragraph. 3. The Management Board shall adopt the practical arrangements for implementing Regulation (EC) No 1049/2001, in cluding appeals or remedies necessary for reviewing a partial or full rejection of a c onfidentiality request, by 1 June 2008. 4. Decisions taken by the Agency pursuant to Article 8 of Regulation (EC) No 1049/2001 may form the subject of a complaint to the Om budsman or of an acti on before the Court of Justice, under the conditions la id down in Articles 195 and 230 of the Treaty respectively. Article 119 Electronic public access 1. The following information held by the Agen cy on substances whether on their own, in preparations or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e): (a) the name in the IUPAC Nomenclature, fo r dangerous substances within the meaning of Directive 67/548/EEC, without prej udice to paragraph 2(f) and (g); (b) if applicable, the name of th e substance as given in EINECS;

223. 30.12.2006 EN Official Journal of the European Union L 396/223 2. Nothing in this Regulation shall prevent Me mber States from maintaining or laying down national rules to prot ect workers, human health and th e environment applying in cases where this Regulation does not harmonise the requirements on manufacture, placing on the market or use. Article 129 Safeguard clause 1. Where a Member State has justifiable grounds for believing that urgent action is essential to protect human health or the environment in respect of a substance, on its own, in a preparation or in an article, even if satis fying the requirements of this Regulation, it may take appropriate provisional measures. The Member State shall immediately inform the Commission, the Agency and the other Member States thereof, giving reasons for its decision and submitting the scientific or technical information on which the provisional measure is based. 2. The Commission shall take a decision in acco rdance with the procedure referred to in Article 133(3) within 60 days of receipt of the information from the Member State. This decision shall either: (a) authorise the provisional measure for a time period defined in the decision; or (b) require the Member State to revoke the provisional measure.

227. 30.12.2006 EN Official Journal of the European Union L 396/227 2. The requests to a notifier to provide further in formation for a substance in accordance with Article 16(1) of Directive 67/548/EEC, shall be considered as decisions adopted in accordance with Article 52 of this Regulation. Such substance shall be regarded as being incl uded in the Community rolling action plan in accordance with Article 44(2) of this Regulation and shall be regarded as being chosen in accordance with Article 45(2) of this Regul ation by the Member State whose competent authority has requested further informati on in accordance with Article 7(2) and Article 16(1) of Directive 67/548/EEC. Article 136 Transitional measures regar ding existing substances 1. The requests to manufacturers and importers to submit information to the Commission made by a Commission Regulation in applica tion of Article 10(2) of Regulation (EEC) No 793/93, shall be considered as decisions ad opted in accordance with Article 52 of this Regulation. The competent authority for the substance shall be the competent authority from the Member State identified as rapporteur in accordance with Article 10(1) of Regulation (EEC) No 793/93 and shall carry ou t the tasks of Article 46(3) and Article 48 of this Regulation.

229. 30.12.2006 EN Official Journal of the European Union L 396/229 Article 137 Transitional measures regarding restrictions 1. By 1 June 2010, the Commission shall, if neces sary, prepare a draft amendment to Annex XVII in accordance with either of the following: (a) any risk evaluation and recommended strategy for limiting risks that has been adopted at Community level in accordan ce with Article 11 of Regulation (EEC) No 793/93 as far as it includes proposals for restrictions in accordance with Title VIII of this Regulation but for wh ich a decision under Directive 76/769/EEC has not yet been taken; (b) any proposal, which has been submitted to the relevant institutions but has not yet been adopted, concerning the introdu ction or the amendment of restrictions under Directive 76/769/EEC. 2. Until 1 June 2010, any dossier referred to in Article 129(3) shall be submitted to the Commission. The Commission shal l, if necessary, prepar e a draft amendment to Annex XVII. 3. Any amendment to the restrictions adopted under Directive 76/769/EEC from 1 June 2007 shall be incorporated in Annex XVII with effect from 1 June 2009.

230. L 396/230 EN Official Journal of the European Union 30.12.2006 Article 138 Review 1. By 1 June 2019, the Commission shall carry ou t a review to assess whether or not to extend the application of the obligation to perform a chemical safety assessment and to document it in a chemical safety report to substances not covered by this obligation because they are not subject to registration or subject to registrati on but manufactured or imported in quantities of less than 10 tonnes pe r year. However, for substances meeting the criteria for classification as carcinogenic, mutagenic or t oxic for reproduction, category 1 or 2, in accordance with Dir ective 67/548/EEC, the review sh all be carried out by 1 June 2014. When carrying out the review the Commission shall take into account all relevant factors, including: (a) the costs for manufacturers and importers of drawing up the chemical safety reports; (b) the distribution of costs between actors in the supply chain and the downstream user; (c) the benefits for human h ealth and the environment. On the basis of these reviews, the Commissi on may, if appropriate, present legislative proposals to extend this obligation.

234. L 396/234 EN Official Journal of the European Union 30.12.2006 3. Article 135 shall appl y from 1 August 2008. 4. Title VIII and Annex XVII shall apply from 1 June 2009. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 18 December 2006. For the European Parliament For the Council The President The President J. BORRELL FONTELLES M. VANHANEN ______

322. L 396/322 EN Official Journal of the European Union 30.12.2006 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 7.11. Explosive properties 7.11. The study does not need to be conducted if: – there are no chemical groups associated with explosive properties present in the molecule; or – the substance contains chemical groups associated with explosive properties which include oxygen and the calculated oxygen balance is less than –200; or – the organic substance or a homogenous mi xture of organic substances contains chemical groups associated with explosive properties, but the exothermic decomposition energy is less than 500 J/g and the onset of exothermic decomposition is below 500 ºC; or – for mixtures of inorganic oxidising substances (UN Division 5.1) with organic materials, the concentration of the inorganic oxidising substance is: – less than 15 %, by mass, if assigned to UN Packaging Group I (high hazard) or II (medium hazard) – less than 30 %, by mass, if assigned to UN Packaging Group III (low hazard). Note : Neither a test for propagation of detonation no r a test for sensitivity to detonative shock is required if the exothermic decomposition energy of organic materials is less than 800 J/g.

327. 30.12.2006 EN Official Journal of the European Union L 396/327 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 8.4. Mutagenicity 8.4. Further mutagenicity studies shall be considered in case of a positive result. 8.4.1. In vitro gene mutation study in bacteria 8.5. Acute toxicity 8.5. The study/ies do(es) not generally need to be conducted if: – the substance is classified as corrosive to the skin. 8.5.1. By oral route The study need not be conducted if a study on acute toxicity by the inhalation route (8.5.2) is available.

334. L 396/334 EN Official Journal of the European Union 30.12.2006 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 8.4.3. In vitro gene mutation study in mammalian cells, if a negative result in Annex VII, section 8.4.1. and Annex VIII, section 8.4.2. 8.4.3. The study does not usually need to be conduc ted if adequate data from a reliable in vivo mammalian gene mutation test are available. 8.4. Appropriate in vivo mutagenicity studies shall be cons idered in case of a positive result in any of the genotoxicity studies in Annex VII or VIII. 8.5. Acute toxicity 8.5. The study/ies do(es) not generally need to be conducted if: – the substance is classified as corrosive to the skin. In addition to the oral route (8.5.1), for subs tances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route need be provided. 8.5.2. By inhalation 8.5.2. Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

354. L 396/354 EN Official Journal of the European Union 30.12.2006 9. ECOTOXICOLOGICAL INFORMATION COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 9.1. Aquatic toxicity 9.1. Long-term toxicity testing sha ll be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment. 9.1.5. Long-term toxicity testing on invertebrates (preferred species Daphnia), (unless already provided as part of Annex VII requirements) 9.1.6. Long-term toxicity testing on fish, (unless already provided as part of Annex VIII requirements) The information shall be provided for one of the sections 9.1.6.1, 9.1.6.2 or 9.1.6.3. 9.1.6.2. Fish early-life stage (FELS) toxicity test 9.1.6.2. Fish short-term toxicity test on embryo and sac-fry stages 9.1.6.3. Fish, juvenile growth test

376. L 396/376 EN Official Journal of the European Union 30.12.2006 If the results obtained from the use of such in vitro methods do not indicate a certain dangerous property, the relevant test shall nevertheless be car ried out at the appropriate tonnage level to confirm the negative result, unless testing is not required in accordance with Annexes VII to X or th e other rules in this Annex. Such confirmation may be waived, if the following conditions are met: 1) results are derived from an in vitro method whose scientific validity has been established by a validation study, according to interna tionally agreed validation principles; 2) results are adequate for the purpose of classification and labelling and/or risk assessment; and 3) adequate and reliable documenta tion of the applied method is provided. 1.5. Grouping of substances a nd read-across approach Substances whose physicochemical, toxicol ogical and ecotoxicolog ical properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or "category" of s ubstances. Application of the group concept requires that physicochemical properties, human health effects and environmental effects or environmental fate may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (read-across appr oach). This avoids the need to test every substance for every endpoint. The Agency, after consulting with relevant stakeholders and othe r interested parties, shall issue guidance on technically and scientifically justified methodology for the group ing of substances sufficiently in advance of the first registration deadline for phase-in substances.

402. L 396/402 EN Official Journal of the European Union 30.12.2006 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction Benzidine and/or its derivatives CAS No 92-87-5 EINECS No 202-199-1 o -Nitrobenzaldehyde CAS No 552-89-6 Wood powder 10. Ammonium sulphide CAS No 12135-76-1 Ammonium hydrogen sulphide CAS No 12124-99-1 Ammonium polysulphide CAS No 9080-17-5 EINECS No 232-989-1

425. 30.12.2006 EN Official Journal of the European Union L 396/425 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 31. (a) creosote; wash oil CAS No 8001-58-9 EINECS No 232-287-5 (b) creosote oil; wash oil CAS No 61789-28-4 EINECS No 263-047-8 (c) distillates (coal tar), naphthalene oils; naphthalene oil CAS No 84650-04-4 EINECS No 283-484-8 1. Shall not be used as substances or in preparations in the treatment of wood. Furthermore, wood so treated shall not be placed on the market. 2. However by way of derogation: (a) Relating to the substances and preparations: these may be used for wood treatment in industrial installations or by professionals covered by Community legislation on the protection of workers for in situ retreatment only if they contain: (i) benzo[a]pyrene at a concentration of less than 0,005 % by mass (ii) and water ex tractable phenols at a concentration of less than 3 % by mass. Such substances and preparations for use in wood treatment in industrial installations or by professionals:

2. L 396/2 EN Official Journal of the European Union 30.12.2006 Whereas: (1) This Regulation should ensure a high le vel of protection of human health and the environment as well as the free movement of su bstances, on their own, in preparations and in articles, while enhancing competitiveness and innovation. This Regulation should also promote the development of alternative methods for the assessment of hazards of substances. (2) The efficient functioning of the internal market for substances can be achieved only if requirements for substances do not di ffer significantly from Member State to Member State. (3) A high level of human hea lth and environmental protecti on should be ensured in the approximation of legislation on substances, with the goal of achieving sustainable development. That legislation should be a pplied in a non-discriminatory manner whether substances are traded on the internal market or internationally in accordance with the Community's international commitments. (4) Pursuant to the implementation plan a dopted on 4 September 2002 at the Johannesburg World Summit on sustainable development, the European Union is aiming to achieve that, by 2020, chemicals are produced and used in wa ys that lead to the minimisation of significant adverse effects on human health and the environment. 1 Opinion of the European Parliament of 17 November 2005 (not yet published in the Official Journal), Council Common Pos ition of 27 June 2006 (OJ C 276E, 14.11.2006, p. 1) and Position of the European Parliament of 13 December 2006 (not yet published in the Official Journal). Council Decision of 18 December 2006.

15. 30.12.2006 EN Official Journal of the European Union L 396/15 (40) The Commission, Member States, industry and other stakeholders should continue to contribute to the promotion of alternative test methods on an international and national level including computer supported methodol ogies, in vitro methodologies, such as appropriate, those based on toxicogenomics, and other relevant methodologies. The Community's strategy to promote alternative test methods is a priority and the Commission should ensure that within its future Resear ch Framework Programmes and initiatives such as the Community Action Plan on the Protec tion and Welfare of Animals 2006-2010 this remains a priority topic. Participation of stakeholders and initiatives involving all interested parties should be sought. (41) For reasons of workability and because of their special nature, specific registration requirements should be laid down for intermediates. Polymers should be exempted from registration and evaluation until those that need to be registered due to the risks posed to human health or the environment can be select ed in a practicable and cost-efficient way on the basis of sound technical a nd valid scientif ic criteria. (42) To avoid overloading author ities and natural or legal person s with the work arising from the registration of phase-in substances alrea dy on the internal mark et, that registration should be spread over an appropriate peri od of time, without in troducing undue delay. Deadlines for the registration of these substances should therefore be set. (43) Data for substances already notified in accordance with Directive 67/548/EEC should be eased into the system and should be upgraded when the next tonnage quantity threshold is reached.

30. L 396/30 EN Official Journal of the European Union 30.12.2006 (92) For reasons of transparency, the Agency should publish the releva nt dossier including the suggested restrictions wh ile requesting comments. (93) In order to finalise the pr ocedure in due time, the Agency should submit its opinions on the suggested action and its impact on the basis of a draft opinion prepared by a rapporteur. (94) In order to speed up the procedure for rest rictions, the Commission should prepare its draft amendment within a specific time lim it of receiving the Agency's opinions. (95) The Agency should be central to en suring that chemicals legislation and the decision-making processes and scientific basi s underlying it have credibility with all stakeholders and the public. The Agency should also play a pivotal role in coordinating communication around this Regulation and in its implementation. The confidence in the Agency of the Community institutions, th e Member States, the general public and interested parties is theref ore essential. For this reas on, it is vital to ensure its independence, high scientific, t echnical and regulatory capacitie s, as well as transparency and efficiency. (96) The structure of the Agency should be suitab le for the tasks that it should fulfil. Experience with similar Community agencies provides some guidance in this respect but the structure should be adapted to meet the specific needs of this Regulation. (97) The effective communication of information on chemical risks and how they can be managed is an essential part of the system established by this Regul ation. Best practice from the chemicals and other sectors should be considered in the preparation of guidance by the Agency to all stakeholders.

54. L 396/54 EN Official Journal of the European Union 30.12.2006 2) Preparation: means a mixture or soluti on composed of two or more substances; 3) Article: means an object which during produc tion is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition; (4) Producer of an article: means any natura l or legal person who makes or assembles an article within the Community; 5) Polymer: means a substance consisting of molecules characterised by the sequence of one or more types of monomer units. Such mol ecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer uni ts. A polymer comprises the following: (a) a simple weight majority of molecules containing at least thre e monomer units which are covalently bound to at least one ot her monomer unit or other reactant; (b) less than a simple weight majority of molecules of the same molecular weight. In the context of this definition a "monomer unit" means the reacted form of a monomer substance in a polymer; 6) Monomer: means a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under th e conditions of the re levant polymer-forming reaction used for the particular process;

56. L 396/56 EN Official Journal of the European Union 30.12.2006 14) Distributor: means any na tural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a preparation, for third parties; 15) Intermediate: means a substance that is ma nufactured for and consumed in or used for chemical processing in order to be transforme d into another substanc e (hereinafter referred to as "synthesis"): (a) non-isolated intermediate: means an in termediate that duri ng synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment in cludes the reaction vessel, its ancillary equipment, and any equipment through wh ich the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from one vessel to another for the purpose of the next r eaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture; (b) on-site isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and where the ma nufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities; (c) transported isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate a nd transported between or supplied to other sites;

68. L 396/68 EN Official Journal of the European Union 30.12.2006 3. The Agency shall check the completeness of the information supp lied by the notifier and Article 20(2) shall apply adapted as necessar y. The Agency shall assign a number to the notification and a notifica tion date, which shall be the date of receipt of the notification at the Agency, and shall forthwith communicate that number and date to the manufacturer, or importer, or producer of arti cles concerned. The Agency sh all also communicate this information to the competent authorit y of the Member State(s) concerned. 4. The Agency may decide to impose conditions with the aim of ensuring that the substance or the preparation or article in which the subs tance is incorporated will be handled only by staff of listed customers as referred to in paragraph 2(e) in reasonably controlled conditions, in accordance with the requirements of legislation for the protection of workers and the environment, and will not be made available to the general public at any time either on its own or in a preparation or ar ticle and that remaining quantities will be re-collected for disposal after the exemption period. In such cases, the Agency may ask the notifie r to provide additional necessary information. 5. In the absence of any indi cation to the contrary, the ma nufacturer or importer of the substance or the producer or importer of artic les may manufacture or import the substance or produce or import the articles not earl ier than two weeks af ter the notification. 6. The manufacturer or importer or producer of articles sha ll comply with any conditions imposed by the Agency in accordance with paragraph 4.

69. 30.12.2006 EN Official Journal of the European Union L 396/69 7. The Agency may decide to extend the five-y ear exemption period by a further maximum of five years or, in the case of substances to be used exclusively in the development of medicinal products for human or veterinary use, or for substances that are not placed on the market, for a further maximum of ten years, upo n request if the manufa cturer or importer or producer of articles can demonstrate that su ch an extension is ju stified by the research and development programme. 8. The Agency shall forthwith communicate any draft decisions to the competent authorities of each Member State in which th e manufacture, import, production or product and process orientated research takes place. When taking decisions as provided for in para graphs 4 and 7, the Ag ency shall take into account any comments made by such competent authorities. 9. The Agency and the competent authorities of the Member States concerned shall always keep confidential the information submitted in accordance with paragraphs 1 to 8. 10. An appeal may be brought, in accordance with Articles 91, 92 and 93, against Agency decisions under paragraphs 4 and 7 of this Article.

103. 30.12.2006 EN Official Journal of the European Union L 396/103 6. Potential registrants who manu facture or import for the first time a phase-in substance in quantities of 1 tonne or more per year or us e for the first time a phase-in substance in the context of production of articles or import for the first time an article containing a phase-in substance that would require registration, afte r 1 December 2008, shall be entitled to rely on Article 23 provided that they submit the info rmation referred to in paragraph 1 of this Article to the Agency within six months of first manufacturing, importing or using the substance in quantities of 1 tonne or more pe r year and no later than 12 months before the relevant deadline in Article 23. 7. Manufacturers or importers of phase-in subs tances in quantities of less than 1 tonne per year that appear on the lis t published by the Agency in acco rdance with paragraph 4 of this Article, as well as downstream users of those substances and third parties holding information on those substances, may submit the information referred to in paragraph 1 of this Article or any other releva nt information to the Agency for those substances, with the intention of being part of the substance in formation exchange forum as referred to in Article 29.

122. L 396/122 EN Official Journal of the European Union 30.12.2006 2. Information relating to testing proposals involving tests on vertebrate animals shall be published on the Agency website. The Agency shall publish on its website the name of the substance, the hazard end-point for which vert ebrate testing is proposed, and the date by which any third party informati on is required. It shall invite third parties to submit, using the format provided by the Agency, scientific ally valid information and studies that address the relevant substance and hazard end-point, addressed by the testing proposal, within 45 days of the date of publication. A ll such scientifically valid information and studies received shall be taken into account by the Agency in preparing its decision in accordance with paragraph 3. 3. On the basis of the examination under para graph 1, the Agency shall draft one of the following decisions and that deci sion shall be taken in accorda nce with the procedure laid down in Articles 50 and 51: (a) a decision requiring the registrant(s) or downstream user(s) concerned to carry out the proposed test and setting a deadline fo r submission of the study summary, or the robust study summary if required by Annex I; (b) a decision in accordance with point (a), but modifying the conditions under which the test is to be carried out; (c) a decision in accordance with points (a), (b) or (d) but requiring registrant(s) or downstream user(s) to carry out one or more additional tests in cases of non-compliance of the testing proposal with Annexes IX, X and XI; (d) a decision rejecting the testing proposal;

194. L 396/194 EN Official Journal of the European Union 30.12.2006 2. The members of the Board of Appeal shall be independent. In making their decisions they shall not be bound by any instructions. 3. The members of the Board of Appeal may not perform any other duties in the Agency. 4. The members of the Board of Appeal may not be removed either from office or from the list during their respectiv e terms, unless there are serious grounds for such removal and the Commission, after obtaining the opinion of the Management Board, takes a decision to this effect. 5. Members of the Board of Appeal may not take part in any appeal proceedings if they have any personal interest therein, or if they have previously been involved as representatives of one of the parties to the pro ceedings, or if they participat ed in the decision under appeal. 6. If a member of the Board of Appeal consider s for reasons mentioned in paragraph 5 that he must not take part in a specific appeal pro ceedings, he shall inform the Board of Appeal accordingly. Members of the Board may be objected to by any party to the appeal proceedings on any of the grounds mentioned in pa ragraph 5, or if suspected of partiality. No objection may be based on the nationality of members. 7. The Board of Appeal shall decide as to the action to be taken in the cases specified in paragraphs 5 and 6 without the participation of the member concerned. For the purposes of taking this decision, the member concerned sha ll be replaced on the Bo ard of Appeal by an alternate.

267. 30.12.2006 EN Official Journal of the European Union L 396/267 ANNEX II GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS This Annex sets out the requirement s for a Safety Data Sheet that is provided for a substance or a preparation in accordance with Article 31. The Safety Data Sheet provides a mechanism for transmitting appropriate safety information on cla ssified substances and preparations, including information from the relevant Chemical Safety Report(s) down the supply chain to the immediate downstream user(s). The information provided in the Safety Data Sheet shall be consistent with the information in the Chemical Safety Report, where one is required. Where a Chemical Safety Report has been performed, the relevant exposure scenario (s) shall be placed into an annex of the Safety Data Sheet, to make reference to them under the rele vant headings of the Sa fety Data Sheet easier. The purpose of this Annex is to ensure consiste ncy and accuracy in the content of each of the mandatory headings listed in Articl e 31, so that the resulting Safety Data Sheets will enable users to take the necessary measures relating to protection of human health and safe ty at the workplace, and protection of the environment. The information provided by Safety Data Sheets shall also meet the requirements set out in Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work. In particular, the Safety Data Sheet shall enable the employer to determine whether any hazardous chemical agents are present in the workplace, and to assess any risk to the health and safety of workers arising from their use.

284. L 396/284 EN Official Journal of the European Union 30.12.2006 Note 1 The above properties shall be determined in accordance with the specif ications laid down in the Commission Regulation on testing methods referred to in Article 13(3) or any other comparable method. Note 2 For preparations, information shall normally be given on the properties of the preparation itself. However, if it is stated that a partic ular hazard does not apply, clearly differentiate between cases where no information is available to the classifier, and cases where negative test results are available. If it is considered necessary to give information about the properties of individual com ponents, please indicate clearl y what the data refers to. 10. STABILITY AND REACTIVITY State the stability of the subs tance or preparation and the possi bility of hazardous reactions occurring under certain conditi ons of use and also if released into the environment. 10.1. Conditions to avoid List those conditions such as temperature, pressure, light, shock, etc., which may cause a dangerous reaction and if possible give a brief description.

296. L 396/296 EN Official Journal of the European Union 30.12.2006 EINECS No Name/Group CAS No 204-664-4 Glycerol stearate, pure C 21 H 42 O 4 123-94-4 204-696-9 Carbon dioxide CO 2 124-38-9 205-278-9 Calcium pantothenate, D-form C 9 H 17 NO 5.1/2 Ca 137-08-6 205-582-1 Lauric acid, pure C 12 H 24 O 2 143-07-7 205-590-5 Potassium oleate C 18 H 34 O 2 K 143-18-0 205-756-7 DL-phenylalanine C 9 H 11 NO 2 150-30-1 208-407-7 Sodium gluconate C 6 H 12 O 7 . Na 527-07-1 212-490-5 Sodium stearate, pure C 18 H 36 O 2 . Na 822-16-2 215-279-6 Limestone A noncombustible solid characteristic of sedimentary rock. It consists primarily of calcium carbonate 1317-65-3 215-665-4 Sorbitan oleate C 24 H 44 O 6 1338-43-8

300. L 396/300 EN Official Journal of the European Union 30.12.2006 EINECS No Name/Group CAS No 232-442-7 Tallow, hydrogenated 8030-12-4 232-675-4 Dextrin 9004-53-9 232-679-6 Starch High-polymeric carbohydrate material usually derived form cereal grains such as corn, wheat and sorghum, and from roots and tubers such as potatoes and tapioca. Includes starch which has been pregelatinised by h eating in the presence of water. 9005-25-8 232-940-4 Maltodextrin 9050-36-6 234-328-2 Vitamin A 11103-57-4 238-976-7 Sodium D-gluconate C 6 H 12 O 7. xNa 14906-97-9 248-027-9 D-glucitol monostearate C 24 H 48 O 7 26836-47-5 262-988-1 Fatty acids, coco, Me esters 61788-59-8 262-989-7 Fatty acids, tallow, Me esters 61788-61-2 263-060-9 Fatty acids, castor-oil 61789-44-4 263-129-3 Fatty acids, tallow 61790-37-2 265-995-8 Cellulose Pulp 65996-61-4

304. L 396/304 EN Official Journal of the European Union 30.12.2006 ANNEX V EXEMPTIONS FROM THE OB LIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b) 1. Substances which result from a chemical reac tion that occurs incidental to exposure of another substance or article to environmenta l factors such as air, moisture, microbial organisms or sunlight. 2. Substances which result from a chemical reac tion that occurs incide ntal to storage of another substance, preparation or article. 3. Substances which result from a chemical reaction occurring upon end use of other substances, preparations or ar ticles and which are not themselves manufactured, imported or placed on the market. 4. Substances which are not themselves manuf actured, imported or placed on the market and which result from a chemical reaction that occurs when: (a) a stabiliser, colorant, flavouring agent, an tioxidant, filler, solven t, carrier, surfactant, plasticiser, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation inhibitor, desiccant, binder, emulsifi er, de-emulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutraliser, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended; or (b) a substance solely intended to provid e a specific physicoche mical characteristic functions as intended.

311. 30.12.2006 EN Official Journal of the European Union L 396/311 2.3.5. Spectral data (ultra-violet, infra-red, nuclear magnetic resonance or mass spectrum) 2.3.6. High-pressure liquid chroma togram, gas chromatogram 2.3.7. Description of the analytical methods or the appropriate bibliographi cal references for the identification of the substance and, where ap propriate, for the iden tification of impurities and additives. This information shall be suffi cient to allow the methods to be reproduced. 3. INFORMATION ON MANUFACTURE AND USE(S) OF THE SUBSTANCE(S) 3.1. Overall manufacture, quantities used for pr oduction of an article that is subject to registration, and/or imports in t onnes per registrant per year in: The calendar year of the regi stration (estimated quantity) 3.2. In the case of a manufacturer or producer of articles: Brief descripti on of the technological process used in manufacture or production of articles Precise details of the process, particularly those of a commercially sensitive nature, are not required. 3.3. An indication of the tonnage used for his own use(s) 3.4. Form (substance, preparation or article) and/ or physical state under which the substance is made available to downstream users. Concentrat ion or concentration range of the substance in preparations made available to downstr eam users and quantities of the substance in articles made available to downstream users.

324. L 396/324 EN Official Journal of the European Union 30.12.2006 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 The full test does not need to be conducted for so lids if the preliminary test clearly indicates that the test substance has oxidising properties. Note that as there is no test method to determin e the oxidising properties of gaseous mixtures, the evaluation of these properties must be realised by an estimation method based on the comparison of the oxidising potential of gases in a mixture w ith that of the oxidisi ng potential of oxygen in air. 7.14. Granulometry 7.14. The study does not need to be conduc ted if the substance is marketed or used in a non solid or granular form.

364. L 396/364 EN Official Journal of the European Union 30.12.2006 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 8.6.4. Further studies shall be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 in case of: – toxicity of particular concern (e.g. serious/severe effects); or – indications of an effect for which th e available evidence is inadequate for toxicological evaluation and/or risk charact erisation. In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity); or – particular concern regarding exposure (e .g. use in consumer products leading to exposure levels which are close to the dose levels at which toxicity is observed). 8.7. Reproductive toxicity 8.7. The studies need not be conducted if: – the substance is known to be a ge notoxic carcinogen and appropriate risk management measures are implemented; or – the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented; or

365. 30.12.2006 EN Official Journal of the European Union L 396/365 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 – the substance is of low toxicological activ ity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive met hod and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure. If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as Repr Cat 1 or 2: R60, and th e available data are adequate to support a robust risk assessment, then no further testi ng for fertility will be necessary. However, testing for development toxicity must be considered. If a substance is known to cause developmen tal toxicity, meeting the criteria for classification as Repr Cat 1 or 2: R61, and th e available data are adequate to support a robust risk assessment, then no further tes ting for developmental toxicity will be necessary. However, testing for effects on fertility must be considered.

379. 30.12.2006 EN Official Journal of the European Union L 396/379 ANNEX XII GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREP ARE CHEMICAL SAFETY REPORTS Introduction The purpose of this Annex is to set out how downs tream users are to assess and document that the risks arising from the substance(s) they use are adequately controll ed during their use for a use not covered by the Safety Data Sheet supplied to th em and that other users further down the supply chain can adequately control the risks. The assess ment shall cover the life- cycle of the substance, from its receipt by the downstream user, for his ow n uses and for his identified uses further down the supply chain. The assessment shall consider the use of the substance on its own, in a preparation or in an article. In carrying out the chemical safety assessment and producing the Chemical Safety Report, the downstream user shall take account of information received from th e supplier of the chemical in accordance with Article 31 and 32 of this Regul ation. Where available and appropriate, an assessment carried out under Community legisl ation, (e.g. risk assessments completed under Regulation (EEC) No 793/93) shall be taken into account in the chem ical safety assessment and be reflected in the Chemical Safety Report. Deviations from such assessments shall be justified. Assessments carried out under othe r international and national progr ammes may also be taken into account.

399. 30.12.2006 EN Official Journal of the European Union L 396/399 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 5. Benzene CAS No 71-43-2 EINECS No 200-753-785 1. Not permitted in toys or parts of toys as placed on the market where the concentration of benzene in the free state is in excess of 5 mg/kg of the weight of the toy or part of toy. 2. Shall not be used in concentrations equal to, or greater than, 0,1 % by mass in substances or preparations placed on the market. 3. However, paragraph 2 shall not apply to: (a) motor fuels which are covered by Directive 98/70/EC; (b) substances and preparations for use in industrial processes not allowing for the emission of benzene in quantities in exce ss of those laid down in existing legislation; (c) waste covered by Council Directive 91/689/EEC of 12 December 1991 on hazardous waste 1 and Directive 2006/12/EC.

400. L 396/400 EN Official Journal of the European Union 30.12.2006 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 6. Asbestos fibres (a) Crocidolite CAS No 12001-28-4 (b) Amosite CAS No 12172-73-5 (c) Anthophyllite CAS No 77536-67-5 1. The placing on the market and use of these fibres and of articles containing these fibres added intentionally shall be prohibited. (d) Actinolite CAS No 77536-66-4 (e) Tremolite CAS No 77536-68-6 (f) Chrysotile 2 CAS No 12001-29-5 CAS No 132207-32-0 However, Member States may except the placing on the market and use of diaphragms containing chrysotile (point (f)) for existing electrolysis installations until they reach the end of their service life, or until suitable asbestos-free substitutes become available, whichever is the sooner. The Commission will review this derogation before 1 January 2008. 2. The use of articles containing asbestos fibres referred to in paragraph 1 which were already installed and/or in service before 1 January 2005 shall continue to be permitted until they are disposed of or reach the end of their service life. However, Member States may, for reasons of protection of human health, prohibit the use of such articles before they are disposed of or reach the end of their service life.

514. L 396/514 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Sodium chromate 024-018-00-3 231-889-5 7775-11-3 E Cobalt dichloride 027-004-00-5 231-589-4 7646-79-9 E Cobalt sulphate 027-005-00-0 233-334-2 10124-43-3 E Potassium bromate 035-003-00-6 231-829-8 7758-01-2 Cadmium oxide 048-002-00-0 215-146-2 1306-19-0 E Cadmium fluoride 048-006-00-2 232-222-0 7790-79-6 E Cadmium chloride 048-008-00-3 233-296-7 10108-64-2 E Cadmium sulphate 048- 009-00-9 233-331-6 10124-36-4 E Cadmium sulphide 048- 010-00-4 215-147-8 1306-23-6 E Cadmium (pyrophoric) 048-011-00-X 231-152-8 7440-43-9 E

757. 30.12.2006 EN Official Journal of the European Union L 396/757 Appendix 3 Point 29 – Mutagens: category 1

274. L 396/274 EN Official Journal of the European Union 30.12.2006 (b) ≥ 0,1 % by weight and the substances are pe rsistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII. 3.4. The classification (derived either from Articles 4 and 6 of Directive 67/548/EEC, from Annex I to Directive 67/548/EEC or from an agreed entry in the classification and labelling inventory established under Titl e XI of this Regulation) of the above substa nces shall be given, including the symbol letters and R phr ases which are assigned in accordance with their physicochemical, human health and environmental hazards. The R phrases do not need to be written out in full here: referen ce shall be made to h eading 16, where the full text of each relevant R phrase shall be listed. If the substance does not meet the classification criteria, the reason for indica ting the substance in section 3 shall be described, such as "PBT-substance" or "subs tance with a Community workplace exposure limit". 3.5. The name and the Registration number, assi gned under Article 20(1) of this Regulation, EINECS or ELINCs number, if available, of the above substances shall be given in accordance with Directive 67/548/EE C. The CAS number and IUPAC name (if available) may also be helpful. For substances listed by a generic name, accord ing to Article 15 of Directive 1999/45/EC or the footnote to Sect ion 3.3 of this Anne x, a precise chemical identifier is not necessary. 3.6. If, in accordance with the provisions of Article 15 of Directive 1999/45/EC or the footnote to Section 3.3 of this Annex, the identity of certain substances is to be kept confidential, their chemical nature shall be described in order to ensure safe handling. The name used shall be the same as that which derives from the above procedures.

287. 30.12.2006 EN Official Journal of the European Union L 396/287 For substances subject to re gistration, summaries of the information derived from the application of Annexes VII to XI of this Regulation shall be given. The information shall also include the result of the comparison of the available data with the criteria given in Directive 67/548/EEC for CMR, categories 1 and 2, following paragraph 1.3.1 of Annex I of this Regulation. 12. ECOLOGICAL INFORMATION Describe the possible effect s, behaviour and environmental fate of the substance or preparation in air, water a nd/or soil. Where available, give relevant test data (e.g. LC50 fish ≤ 1 mg/l). The information in this section shall be cons istent with the information provided for in a registration where required and/or in a Chemical Safe ty Report where required. Describe the most important characteristics likely to have an effect on the environment owing to the nature of the substance or prep aration and likely methods of use. Information of the same kind shall be supplied for danger ous products arising from the degradation of substances and preparations. Th is may include the following:

447. 30.12.2006 EN Official Journal of the European Union L 396/447 Note N: The classification as a carcinogen need not a pply if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen. Note P: The classification as a carcinogen need not a pply if it can be shown that the substance contains less than 0,1 % w/w benzene (EINECS No 200-753-7). Note R: The classification as a carcinogen need not apply to fibres with a length weighted geometric mean diameter, less two standard errors, greater than 6 μ m. Note S: This substance may not require a label acco rding to Article 23 of Directive 67/548/EEC (see section 8 of Annex VI of that Directive).

505. 30.12.2006 EN Official Journal of the European Union L 396/505 Substances Index number EC number CAS number Notes Tail gas (petroleum), vacuum gas oil hydrodesulphuriser, hydrogen sulphide-free; Petroleum gas (A complex combination of hydrocarbons obtained from catalytic hydrodesulphurisation of vacuum gas oil and from which hydrogen sulphide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-190-00-2 269-632-4 68308-12-3 H, K Gases (petroleum), catalytic cracked overheads; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of products from the catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 3 through C 5 and boiling in the range of approximately − 48 °C to 32 °C.) 649-191-00-8 270-071-2 68409-99-4 H, K Alkanes, C 1-2 ; Petroleum gas 649-193-00-9 270-651-5 68475-57-0 H, K Alkanes, C 2-3 ; Petroleum gas 649-194-00-4 270-652-0 68475-58-1 H, K Alkanes, C 3-4 ; Petroleum gas 649-195-00-X 270-653-6 68475-59-2 H, K

676. L 396/676 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Naphtha (petroleum), light thermal cracked; Low boiling point thermally cracked naphtha (A complex combination of hydrocarbons from distillation of products from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C 4 through C 8 and boiling in the range of approximately − 10°C to 130°C.) 649-316-00-6 265-075-6 64741-74-8 P Naphtha (petroleum), heavy thermal cracked; Low boiling point thermally cracked naphtha (A complex combination of hydrocarbons from distillation of products from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C 6 through C 12 and boiling in the range of approximately 65°C to 220°C.) 649-317-00-1 265-085-0 64741-83-9 P

684. L 396/684 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (petroleum), light distillate hydrotreating process, low-boiling; Low boiling point hydrogen treated naphtha (A complex combination of hydrocarbons obtained by the distillation of products from the light distillate hydrotre ating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 6 through C 9 and boiling in the range of approximately 3°C to 194°C.) 649-332-00-3 270-093-2 68410-97-9 P Distillates (petrole um), hydrotreated heavy naphtha, deisohexaniser overheads; Low boiling point hydrogen treated naphtha 649-333-00-9 270-094-8 68410-98-0 P (A complex combination of hydrocarbons obtained by distillation of the products from a heavy naphtha hydrotreating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C 3 through C 6 and boiling in the range of approximately − 49°C to 68°C.)

686. L 396/686 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Naphtha (petroleum), hydrotreated light, cycloalkane-contg.; Low boiling point hydrogen treated naphtha (A complex combination of hydrocarbons obtained from the distillation of a pe troleum fraction. It consists predominantly of alkanes and cycloalkanes boiling in the range of approximately − 20°C to 190°C.) 649-336-00-5 285-512-4 85116-61-6 P Naphtha (petroleum), heavy steam-cracked, hydrogenated; Low boiling point hydrogen treated naphtha 649-337-00-0 295-432-1 92045-51-7 P Naphtha (petroleum), hydrodesulphurised full-range; Low boiling point hydrogen treated naphtha (A complex combination of hydrocarbons obtained from a catalytic hydrodesulphurisation process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 4 through C 11 and boiling in the range of approximately 30°C to 250°C.) 649-338-00-6 295-433-7 92045-52-8 P

691. 30.12.2006 EN Official Journal of the European Union L 396/691 Substances Index number EC number CAS number Notes Naphtha (petroleum), light hydrocracked; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons from distillation of the products from a hydrocracking process. It consists predominantly of saturated hydrocar bons having carbon numbers predominantly in the range of C 4 through C 10 , and boiling in the range of approximately − 20°C to 180°C.) 649-348-00-0 265-071-4 64741-69-1 P Naphtha (petroleum) heavy hydrocracked; Low boiling point naphtha – unspecified (A complex combination of hydrocarbons from distillation of the products from a hydrocracking process. It consists predominantly of saturated hydrocar bons having carbon numbers predominantly in the range of C 6 through C 12 , and boiling in the range of approximately 65°C to 230°C.) 649-349-00-6 265-079-8 64741-78-2 P

712. L 396/712 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Hydrocarbons, C 5 -rich, dicyclopentadiene-c ontg.; low boiling point naphtha – unspecified 649-399-00-9 310-013-6 102110-15-6 P (A complex combination of hydrocarbons obtained by distillation of the products from a steam-cracking process. It consists predominantly of hydrocarbons having carbon numbers of C 5 and dicyclopentadiene and boiling in the range of approximately 30°C to 170°C.) Residues (petroleum), steam-cracked light, arom.; low boiling point naphtha – unspecified (A complex combination of hydrocarbons obtained by the distillation of the products of steam cracking or simila r processes after taking off the very light products resulting in a resi due starting with hydrocarbons having carbon numbers greater than C 5 . It consists predominantly of aromatic hydrocarbons having carbon numbers greater than C 5 and boiling above approximately 40°C.) 649-400-00-2 310-057-6 102110-55-4 P Hydrocarbons, C ≥ 5 , C 5-6 -rich; low boiling point naphtha – unspecified 649-401-00-8 270-690-8 68476-50-6 P Hydrocarbons, C 5 -rich; low boiling point naphtha – unspecified 649-402-00-3 270-695-5 68476-55-1 P Aromatic hydrocarbons, C 8-10 ; Light oil redistillate, high boiling 649-403-00-9 292-695-4 90989-39-2 P

774. L 396/774 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Residues (petroleum), alkylation splitter, C 4 -rich; Petroleum gas (A complex residuum from the distillation of streams from various refinery operations. It consists of hydrocarbons having carbon numbers in the range of C 4 through C 5 , predominantly butane, and boiling in the range of approximately − 11,7 °C to 27,8 °C.) 649-087-00-2 271-010-2 68513-66-6 H, K Hydrocarbons, C 1-4 ; Petroleum gas (A complex combination of hydrocarbons provided by thermal cracking and absorber operations and by distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 and boiling in the range of approximately minus 164 °C to minus 0.5 °C.) 649-088-00-8 271-032-2 68514-31-8 H, K

277. 30.12.2006 EN Official Journal of the European Union L 396/277 Note If appropriate refer to headings 8 and 13. 7. HANDLING AND STORAGE Note Information in this section shall relate to the protection of human health, safety and the environment. It shall assist the employer in devising su itable working procedures and organisational measures according to Article 5 of Directive 98/24/EC. Where a chemical safety report or a registrati on is required, the information in this section shall be consistent with the information given, for the identified uses and exposure scenarios set out in the annex to the Safety Data Sheet. 7.1. Handling Specify precautions for safe handling incl uding advice on technical measures such as: – containment, local and general ventilati on, measures to prevent aerosol and dust generation and fire, measures required to pr otect the environment (e.g. use of filters or scrubbers on exhaust ventilation, use in a bunded area, measures for collection and disposal of spillages, etc.) and any speci fic requirements or rules relating to the substance or preparation (e.g. procedures or equipment which are prohibited or recommended) and if possible give a brief description.

278. L 396/278 EN Official Journal of the European Union 30.12.2006 7.2. Storage Specify the conditions for safe storage such as: – specific design for storage rooms or ve ssels (including re tention walls and ventilation), incompatible materials, conditi ons of storage (temperature and humidity limit/range, light, inert gas, etc.) special elec trical equipment and prevention of static electricity. Give advice if relevant on quantity limits under storage conditions. In particular indicate any special requirements such as the type of ma terial used in the packaging/containers of the substance or preparation. 7.3. Specific use(s) For end products designed for specific use(s), recommendations shall refer to the identified use(s) and be detailed and operati onal. If possible, reference sh all be made to industry – or sector – specific approved guidance. 8. EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1. Exposure limit values Specify currently applicable specific cont rol parameters includi ng occupational exposure limit values and/or biological limit values. Va lues shall be given for the Member State where the substance or preparation is placed on the market. Give information on currently recommended monitoring procedures.

423. 30.12.2006 EN Official Journal of the European Union L 396/423 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction (c) in articles such as those listed in point (b) where these have a non-nickel coating unless such coating is sufficient to ensure that the rate of nickel release from those parts of such articles coming into direct and prolonged contact with the skin will not exceed 0,5 μg/cm2/week for a period of at least two years of normal use of the article. 2. Articles which are the subject of paragraph 1, shall no t be placed on the market unless they conform to the requirements set out in those points. 3. The standards adopted by the European Committee for Standardisation (CEN) shall be used as the test methods for demonstrating the conformity of articles to paragraphs 1 and 2. 28. Substances which appear in Annex I to Directive 67/548/EEC classified as carcinogen category 1 or carcinogen category 2 and labelled at least as "Toxic (T)" with risk phrase R 45: "May cause cancer" or risk phrase R49: "May cause cancer by inhalation", and listed as follows: Carcinogen category 1 listed in Appendix 1. Without prejudice to the other parts of this Annex the following shall apply to entries 28 to 30: 1. Shall not be used in substances and preparations placed on the market for sale to the general public in in dividual concentration equal to or greater than: – either the relevant concentration specified in Annex I to Directive 67/548/EEC, or

318. L 396/318 EN Official Journal of the European Union 30.12.2006 7. INFORMATION ON THE PHYSICOCHEMICA L PROPERTIES OF THE SUBSTANCE COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 7.1. State of the substance at 20 o C and 101,3 kPa 7.2. Melting/freezing point 7.2. The study does not need to be conducted below a lower limit of -20 C. 7.3. Boiling point 7.3. The study does not need to be conducted: – for gases; or – for solids which either melt above 300 ° C or decompose before boiling. In such cases the boiling point under reduced pressure may be estimated or measured; or – for substances which decompose before bo iling (e.g. auto-oxidation, rearrangement, degradation, decomposition, etc.). 7.4. Relative density 7.4. The study does not need to be conducted if: – the substance is only stable in solution in a particular solvent and the solution density is similar to that of the solvent. In such cases, an indication of whether the solution density is higher or lower than the solvent density is sufficient; or – the substance is a gas. In this case, an estimation based on calculation shall be made from its molecular weight and the Ideal Gas Laws.

523. 30.12.2006 EN Official Journal of the European Union L 396/523 Substances Index number EC number CAS number Notes 4-Chloro-o-toluidine [1] 4-chloro-o-toluidine hydrochloride [2] 612-196-00-0 202-441-6 [1] 221-627-8 [2] 95-69-2 [1] 3165-93-3 [2] E 2,4,5-Trimethylaniline [1] 2,4,5-trimethylaniline hydrochloride [2] 612-197-00-6 205-282-0 [1] - [2] 137-17-7 [1] 21436-97-5 [2] E 4,4'-Thiodianiline [1] and its salts 612-198-00-1 205-370-9 [1] 139-65-1 [1] E 4,4'-Oxydianiline [1] and its salts p-Aminophenyl ether [1] 612-199-00-7 202-977-0 [1] 101-80-4 [1] E 2,4-Diaminoanisole [1] 4-methoxy-m-phenylenediamine 2,4-diaminoanisole sulphate [2] 612-200-00-0 210-406-1 [1] 254-323-9 [2] 615-05-4 [1] 39156-41-7 [2] N,N,N',N'-tetramethyl-4,4'- methylendianiline 612-201-00-6 202-959-2 101-61-1 C.I. Basic Violet 3 with ≥ 0,1 % of Michler's ketone (EC No 202-027-5) 612-205-00-8 208-953-6 548-62-9 E

169. 30.12.2006 EN Official Journal of the European Union L 396/169 Article 71 Agency opinion: Committee for Socio-economic Analysis 1. Within 12 months of the date of publicati on referred to in Article 69(6), the Committee for Socio-economic Analysis shall formulat e an opinion on the suggested restrictions, based on its consideration of the relevant parts of the dossier and the socio-economic impact. It shall prepare a draft opinion on th e suggested restrictions and on the related socio-economic impact, taking account of th e analyses or information according to point (b) of Article 69(6), if there are any. The Agency sh all publish the draft opinion on its website without delay. The Agen cy shall invite interested pa rties to give their comments on the draft opinion no later than 60 days fr om the publication of that draft opinion. 2. The Committee for Socio-economic Analysis shall without delay a dopt its opinion, taking into account where appropriate further commen ts received by the deadline set. This opinion shall take account of the comments and socio-economic analyses of interested parties submitted under point (b) of Article 69 (6) and under paragraph 1 of this Article. 3. Where the opinion of the Committee for Risk Assessment diverges significantly from the restrictions suggested, the Agency may postpone the dead line for the opinion of the Committee for Socio-economic Analysis by a maximum of 90 days.

47. 30.12.2006 EN Official Journal of the European Union L 396/47 TITLE I GENERAL ISSUES Chapter 1 Aim, scope and application Article 1 Aim and scope 1. The purpose of this Regulation is to ensure a high level of protection of human health and the environment, including the promotion of al ternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. 2. This Regulation lays down provisions on subs tances and preparations within the meaning of Article 3. These provisions sh all apply to the manufacture, placing on the market or use of such substances on their ow n, in preparations or in arti cles and to the placing on the market of preparations. 3. This Regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they ma nufacture, place on the market or use such substances that do not adversely affect human h ealth or the environment. Its provisions are underpinned by the precautionary principle.

53. 30.12.2006 EN Official Journal of the European Union L 396/53 (ii) the information required by Articles 31 or 32 relating to the substance that has been registered in accordance with Title II is available to the establishment undertaking the recovery. 8. On-site isolated intermediates and transporte d isolated intermediates shall be exempted from: (a) Chapter 1 of Title II, with the exception of Articles 8 and 9; and (b) Title VII. 9. The provisions of Titles II and VI shall not apply to polymers. Chapter 2 Definitions and general provision Article 3 Definitions For the purposes of this Regulation: 1) Substance: means a chemical element and it s compounds in the natura l state or obtained by any manufacturing process, including any addi tive necessary to preserve its stability and any impurity deriving from the process use d, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

75. 30.12.2006 EN Official Journal of the European Union L 396/75 3. This Article shall apply to producer s of articles adapted as necessary. Article 13 General requirements for ge neration of information on intrinsic properties of substances 1. Information on intrinsic properties of substa nces may be generated by means other than tests, provided that the conditi ons set out in Annex XI are met. In particular for human toxicity, information shall be generated whenev er possible by means other than vertebrate animal tests, through the use of alternative methods, for ex ample, in vitro methods or qualitative or quantitative structure-activity re lationship models or from information from structurally related substances (grouping or read-across). Testing in accordance with Annex VIII, section 8.6 and 8.7, Annex IX a nd Annex X may be omitted where justified by information on exposure and implemented risk management measures as specified in Annex XI, section 3. 2. These methods shall be regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved. The Commission, following consultation with relevant stakeholders, sha ll, as soon as possible, make a proposal, if appropriate, to amend the Commission Regulat ion on test methods adopted in accordance with the procedure referred to in Article 133(4), and the A nnexes of this Regulation, if relevant, so as to replace, re duce or refine animal testing. Amendments to that Commission Regulation shall be adopted in accordance with the procedure specified in paragraph 3 and amendments to the Annexes of this Regulat ion shall be adopted in accordance with the procedure referred to in Article 131.

82. L 396/82 EN Official Journal of the European Union 30.12.2006 Chapter 3 Obligation to register a nd information requirements for certain types of is olated intermediates Article 17 Registration of on-site isolated intermediates 1. Any manufacturer of an on-site isolated intermediate in qua ntities of 1 tonne or more per year shall submit a registration to the Ag ency for the on-site isolated intermediate. 2. A registration for an on-site isolated intermediate shall include all the following information, to the extent that the manufacturer is able to submit it without any additional testing: (a) the identity of the manufacturer as specified in sec tion 1 of Annex VI; (b) the identity of the intermediate as sp ecified in sections 2.1 to 2.3.4 of Annex VI; (c) the classification of the intermediate as specified in section 4 of Annex VI; (d) any available existing information on physicochemical, human health or environmental properties of the intermediate . Where a full study report is available, a study summary shall be submitted;

87. 30.12.2006 EN Official Journal of the European Union L 396/87 (c) he disagrees with the lead registra nt on the selection of this information. If points (a), (b) or (c) ap ply, the manufacturer or importer shall submit, along with the dossier, an explanation as to why the costs w ould be disproportionate , why disclosure of information was likely to lead to substantial commercial detriment, or the nature of the disagreement, as the case may be. 3. A submission for registration shall be accomp anied by the fee required in accordance with Title IX. Chapter 4 Common provisions for all registrations Article 20 Duties of the Agency 1. The Agency shall assign a submission number to each registration, which is to be used for all correspondence regarding th e registration until the regi stration is deemed to be complete, and a submission date, which shall be th e date of receipt of the registration at the Agency. 2. The Agency shall undertake a completeness chec k of each registration in order to ascertain that all the elements requir ed under Articles 10 and 12 or unde r Articles 17 or 18, as well as the registration fee referred to in Article 6(4), Article 7(1) and (5), Article 17(2) or Article 18(2), have been provided. The complete ness check shall not include an assessment of the quality or the adequacy of any data or justifications submitted.

94. L 396/94 EN Official Journal of the European Union 30.12.2006 Chapter 5 Transitional provisions applicable to phase-in substanc es and notified substances Article 23 Specific provisions for phase-in substances 1. Article 5, Article 6, Article 7(1), Article 17, Article 18 and Article 21 shall not apply until 1 December 2010 to the following substances: (a) phase-in substances classi fied as carcinogenic, mutage nic or toxic to reproduction, category 1 or 2, in accordance with Dir ective 67/548/EEC and manufactured in the Community or imported, in quantities reaching 1 tonne or more per year per manufacturer or per importer, at least once after 1 June 2007; (b) phase-in substances classi fied as very toxic to aqua tic organisms which may cause long-term adverse effects in the aquatic environment (R50/53) in accordance with Directive 67/548/EEC, and manufactured in the Community or imported in quantities reaching 100 tonnes or more per year per ma nufacturer or per importer, at least once after 1 June 2007; (c) phase-in substances manufactured in th e Community or impo rted, in quantities reaching 1 000 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007.

96. L 396/96 EN Official Journal of the European Union 30.12.2006 TITLE III DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING Chapter 1 Objectives and general rules Article 25 Objectives and general rules 1. In order to avoid animal te sting, testing on vertebrate anim als for the purposes of this Regulation shall be undertaken only as a last resort. It is also necessary to take measures limiting duplication of other tests. 2. The sharing and joint submission of informa tion in accordance with this Regulation shall concern technical data and in particular information related to the intrinsic properties of substances. Registrants shall refrain from ex changing information concerning their market behaviour, in particular as regards production capacities, production or sales volumes, import volumes or market shares. 3. Any study summaries or robust study summaries of studies submitted in the framework of a registration under this Regula tion at least 12 years previ ously can be used for the purposes of registration by anothe r manufacturer or importer.

97. 30.12.2006 EN Official Journal of the European Union L 396/97 Chapter 2 Rules for non-phase-in subs tances and registrants of phase-in substances who ha ve not pre-registered Article 26 Duty to inquire prior to registration 1. Every potential registrant of a non-phase-in substance, or poten tial registrant of a phase-in substance who has not pre-registered in accord ance with Article 28, shall inquire from the Agency whether a registration has already been submitted for the same substance. He shall submit all the following information to the Agency with the inquiry: (a) his identity as specified in section 1 of Annex VI, with the exception of the use sites; (b) the identity of the substance, as specified in section 2 of Annex VI; (c) which information requirements would require new studies involving vertebrate animals to be carried out by him; (d) which information requirements would requ ire other new studies to be carried out by him. 2. If the same substance has previously not b een registered, the Agency shall inform the potential registra nt accordingly.

107. 30.12.2006 EN Official Journal of the European Union L 396/107 4. If the owner of a study as referred to in paragraph 1 which does not involve testing on vertebrate animals refuses to prov ide either proof of the cost of that study or the study itself to (an)other participant(s), the other SIEF part icipants shall proceed wi th registration as if no relevant study was available in the SIEF. 5. An appeal may be brought, in accordance with Articles 91, 92 and 93, against Agency decisions under paragraphs 2 or 3 of this Article. 6. The owner of the study who has refused to prov ide either proof of th e cost or the study itself, as referred to in paragraph 3 or 4 of this Article, shall be penalised in accordance with Article 126. TITLE IV INFORMATION IN THE SUPPLY CHAIN Article 31 Requirements for Safety Data Sheets 1. The supplier of a substance or a preparation shall provide the recipient of the substance or preparation with a safety data sheet compiled in accordance with Annex II: (a) where a substance or preparation meets th e criteria for classification as dangerous in accordance with Directives 67/548/EEC or 1999/45/EC; or (b) where a substance is persistent, bioaccumula tive and toxic or very persistent and very bioaccumulative in accordance with the cr iteria set out in Annex XIII; or (c) where a substance is included in the list established in accordance with Article 59(1) for reasons other than those refe rred to in points (a) and (b).

115. 30.12.2006 EN Official Journal of the European Union L 396/115 2. In the event of a regi strant, downstream user or distribut or ceasing activit y, or transferring part or all of his operations to a third party, the party responsible for liquidating the registrant, downstream user or distributor's undertaking or assuming responsibility for the placing on the market of the substance or preparation concerne d shall be bound by the obligation in paragraph 1 in place of the re gistrant, downstream user or distributor. TITLE V DOWNSTREAM USERS Article 37 Downstream user chemical safety assessments and duty to identify, apply and reco mmend risk reduction measures 1. A downstream user or distributo r may provide information to a ssist in the preparation of a registration. 2. Any downstream user shall have the right to make a use, as a minimum the brief general description of use, known in writing (on pape r or electronically) to the manufacturer, importer, downstream user or distributor who supplies him with a substance on its own or in a preparation with the aim of making this an identified use. In making a use known, he shall provide sufficient information to allo w the manufacturer, im porter or downstream user who has supplied the substa nce, to prepare an exposure s cenario, or if appropriate a use and exposure category, for his use in th e manufacturer, importer or downstream user's chemical safety assessment. Distributors shall pass on such information to the next acto r or distributor up the supply chain. Downstream users in receipt of such information may prepare an exposure scenario for the identified use(s), or pass the inform ation to the next ac tor up the supply chain.

121. 30.12.2006 EN Official Journal of the European Union L 396/121 2. Downstream users shall be required to comply with the requirements of Article 38 at the latest six months after recei ving a registration number co mmunicated to them by their suppliers in a safety data sheet. TITLE VI EVALUATION Chapter 1 Dossier evaluation Article 40 Examination of testing proposals 1. The Agency shall examine any testing proposal set out in a regist ration or a downstream user report for provision of the information sp ecified in Annexes IX and X for a substance. Priority shall be given to regi strations of substances which have or may have PBT, vPvB, sensitising and/or carc inogenic, mutagenic or toxic for reproduction (CMR) properties, or substances classified as dangerous accord ing to Directive 67/ 548/EEC above 100 tonnes per year with uses resulting in widespread and diffuse exposure.

127. 30.12.2006 EN Official Journal of the European Union L 396/127 Chapter 2 Substance evaluation Article 44 Criteria for substance evaluation 1. In order to ensure a harmonised approac h, the Agency shall in cooperation with the Member States develop criteria for priori tising substances with a view to further evaluation. Prioritisation shall be on a risk-based appro ach. The criteria shall consider: (a) hazard information, for instance structural similarity of the substance with known substances of concern or with substan ces which are persistent and liable to bio-accumulate, suggesting that the substan ce or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate; (b) exposure information; (c) tonnage, including aggregated tonnage from the registrations submitted by several registrants.

133. 30.12.2006 EN Official Journal of the European Union L 396/133 (b) examine any information submitted and, if necessary, recommend any appropriate risk reduction measures to address the risks identi fied in relation to the site in question. The procedure provided for in the first para graph may be undertaken only by the competent authority referred to therein. The competent authority shall inform the Agency of the results of such an evaluation, which shall then inform the compet ent authorities of the ot her Member States and make the results available to them. Chapter 4 Common provisions Article 50 Registrants' and downs tream users' rights 1. The Agency shall notify any dr aft decision under Ar ticles 40, 41 or 46 to the registrant(s) or downstream user(s) concerned, informing them of their right to comment within 30 days of receipt. If the concerned registrant(s) or downstream user(s) wish to comment, they shall provide their comments to the Agency. The Ag ency in turn shall inform the competent authority of the submission of the comments without delay. The competent authority (for decisions taken under Article 46) and the Agen cy (for decisions taken under Articles 40 and 41) shall take any comments received in to account and may amend the draft decision accordingly.

148. L 396/148 EN Official Journal of the European Union 30.12.2006 8. If, within 30 days of the referral, th e Member State Committee reaches a unanimous agreement on the identification, th e Agency shall include the s ubstance in the list referred to in paragraph 1. The Agency may include th at substance in its recommendations under Article 58(3). 9. If the Member State Committee fails to re ach a unanimous agreement, the Commission shall prepare a draft proposal on the identificat ion of the substance wi thin three months of receipt of the opinion of the Member State Committee. A final decision on the identification of the substance shall be taken in accordance with the procedure referred to in Article 133(3). 10. The Agency shall publish and update the list referred to in paragraph 1 on its website without delay after a decision on inclus ion of a substance has been taken. Chapter 2 Granting of authorisations Article 60 Granting of authorisations 1. The Commission shall be responsible fo r taking decisions on applications for authorisations in accordance with this Title.

163. 30.12.2006 EN Official Journal of the European Union L 396/163 TITLE VIII RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES Chapter 1 General issues Article 67 General provisions 1. A substance on its own, in a preparation or in an article, for which Annex XVII contains a restriction shall not be manuf actured, placed on the market or used unless it complies with the conditions of that restrict ion. This shall not apply to the manufacture, placing on the market or use of a substance in scientific research and development. Annex XVII shall specify if the restriction shall not apply to product and process orie ntated research and development, as well as the maximum quantity exempted. 2. Paragraph 1 shall not apply to the use of substances in co smetic products, as defined by Directive 76/768/EEC, with regard to restric tions addressing the risks to human health within the scope of that Directive.

164. L 396/164 EN Official Journal of the European Union 30.12.2006 3. Until 1 June 2013, a Member State may main tain any existing and more stringent restrictions in relation to A nnex XVII on the manufacture, plac ing on the market or use of a substance, provided that those restrictions have been notified acco rding to the Treaty. The Commission shall compile a nd publish an inventory of th ese restrictions by 1 June 2009. Chapter 2 Restrictions process Article 68 Introducing new and amending current restrictions 1. When there is an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of substances, which needs to be addressed on a Community-wide basis, Annex XVII shall be am ended in accordance with the procedure referred to in Article 133(4) by adopting new re strictions, or amending current restrictions in Annex XVII, for the manufacture, use or placing on the market of substances on their own, in preparations or in ar ticles, pursuant to the proced ure set out in Articles 69 to 73. Any such decision shall take into account the socio-economic impact of the restriction, including the availability of alternatives. The first subparagraph shall not apply to the use of a substance as an on-site isolated intermediate.

171. 30.12.2006 EN Official Journal of the European Union L 396/171 Where the draft amendment diverges from the or iginal proposal or if it does not take the opinions from the Agency into account, the Commission shall annex a detailed explanation of the reasons for the differences. 2. A final decision shall be taken in accorda nce with the procedure referred to in Article 133(4). The Commission shall send the dr aft amendment to the Member States at least 45 days before voting. TITLE IX FEES AND CHARGES Article 74 Fees and charges 1. The fees that are required acco rding to Article 6(4), Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2), Article 18(2), Article 19(3), Ar ticle 22(5), Article 62(7) and Article 92(3) shall be specifi ed in a Commission Regulation adopted in accordance with the procedure referred to in Article 133(3) by 1 June 2008. 2. A fee need not be paid for a registration of a substance in a quantity of between 1 and 10 tonnes where the registration dossier cont ains the full information in Annex VII.

213. 30.12.2006 EN Official Journal of the European Union L 396/213 TITLE XII INFORMATION Article 117 Reporting 1. Every five years, Member States shall s ubmit to the Commission a report on the operation of this Regulation in their respective te rritories, including sections on evaluation and enforcement as described in Article 127. The first report shall be submitted by 1 June 2010. 2. Every five years, the Agency shall submit to the Commission a report on the operation of this Regulation. The Agency shall include in its report information on the joint submission of information in accordance with Article 11 an d an overview of the explanations given for submitting information separately. The first report shall be submitted by 1 June 2011. 3. Every three years the Agency, in accordance with the objective of promoting non-animal testing methods, shall submit to the Commissi on a report on the status of implementation and use of non-animal test methods and testing strategies used to generate information on intrinsic properties and for risk assessment to meet the requirement s of this Regulation. The first report shall be submitted by 1 June 2011.

294. L 396/294 EN Official Journal of the European Union 30.12.2006 ANNEX III CRITERIA FOR SUBSTANCES REGISTER ED IN QUANTITIES BETWEEN 1 AND 10 TONNES Criteria for substances register ed between 1 and 10 tonnes, with reference to Article 12(1)(a) and (b): (a) substances for which it is predicted (ie by the application of (Q)S ARs or other evidence) that they are likely to meet the criteria for category 1 or 2 classification for carcinogenicity, mutagenicity or reproductive toxicity or the criteria in Annex XIII, (b) substances: (i) with dispersive or diffuse use(s) particularly where su ch substances are used in consumer preparations or incorporated into consumer articles; and (ii) for which it is predicted (i.e. by applica tion of (Q)SARs or other evidence) that they are likely to meet the cla ssification criteria for any hu man health or environmental effects endpoints under Directive 67/548/EEC.

386. L 396/386 EN Official Journal of the European Union 30.12.2006 ANNEX XIV LIST OF SUBSTANCES SUBJECT TO AUTHORISATION

439. 30.12.2006 EN Official Journal of the European Union L 396/439 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 50. Polycyclic-aromatic hydrocarbons (PAH) 1. Benzo(a)pyrene (BaP) CAS No 50-32-8 2. Benzo(e)pyrene (BeP) CAS No 192-97-2 3. Benzo(a)anthracene (BaA) CAS No 56-55-3 4. Chrysen (CHR) CAS No 218-01-9 5. Benzo(b)fluoranthene (BbFA) CAS No 205-99-2 6. Benzo(j)fluoranthene (BjFA) CAS No 205-82-3 7. Benzo(k)fluoranthene (BkFA) CAS No 207-08-9 8. Dibenzo(a, h)anthracene (DBAhA) CAS No 53-70-3 1. Extender oils shall not be placed on the market and used for the production of tyres or parts of tyres, if they contain: — more than 1 mg/kg BaP, or — more than 10 mg/kg of the sum of all listed PAHs. These limits are regarded as kept, if the polycyclic aromatics (PCA) extract is less than 3 % by mass, as measured by the Institute of Petroleum standard IP346: 1998 (Determination of PCA in unused lubricating base oils and asphaltene free petroleum fractions — Dimethyl sulphoxide extraction refractive index method), provided that compliance with the limit values of BaP and of the listed PAHs, as well as the correlation of the measured values with the PCA extract, is controlled by the manufacturer or importer every six months or after each major operational change, whichever is earlier. 2. Furthermore, the tyres and treads for retreading manufactured after 1 January 2010 may not be placed on the market if they contain extender oils exceeding the limits indicated in paragraph 1. These limits are regarded as kept, if the vulcanised rubber compounds do not exceed the limit of 0,35 % Bay protons as measured and calculated by ISO 21461 (Rubber vulcanised — Determination of aromaticity of oil in vulcanised rubber compounds). 3. By way of derogation, paragraph 2 shall not apply to retreaded tyres if their tread does not contain extender oils exceeding the limits referred to in paragraph 1. 4. Member States shall apply these measures from 1 January 2010.

70. L 396/70 EN Official Journal of the European Union 30.12.2006 Article 10 Information to be submitted fo r general registration purposes A registration required by Article 6 or by Artic le 7(1) or (5) shall include all the following information: (a) a technical dossier including: (i) the identity of the manufacturer(s) or importer(s) as specifi ed in section 1 of Annex VI; (ii) the identity of the substance as specified in section 2 of Annex VI; (iii) information on the manufacture and use(s) of the substance as specified in section 3 of Annex VI; this information shall repres ent all the registrant's identified use(s). This information may include, if the regist rant deems appropriate, the relevant use and exposure categories; (iv) the classification and la belling of the substance as specified in section 4 of Annex VI; (v) guidance on safe use of the substance as specified in Section 5 of Annex VI; (vi) study summaries of the information deri ved from the application of Annexes VII to XI;

72. L 396/72 EN Official Journal of the European Union 30.12.2006 Article 11 Joint submission of data by multiple registrants 1. When a substance is intended to be manu factured in the Community by one or more manufacturers and/or imported by one or more importers, and/or is s ubject to registration under Article 7, the fo llowing shall apply. Subject to paragraph 3, the information specified in Article 10(a)(iv), (vi), (vii) and (ix), and any relevant indication under Article 10(a )(viii) shall first be submitted by the one registrant acting with the agreement of the other assenting regist rant(s) (hereinafter referred to as "the lead registrant"). Each registrant shall subsequently submit separately the information specified in Article 10(a)(i), (ii), (iii) and (x), and any relevant indication under Arti cle 10(a)(viii). The registrants may decide themselves whet her to submit the information specified in Article 10(a)(v) and (b) and any relevant indication under Articl e 10(a)(viii) separately or whether one registrant is to submit this information on behalf of the others. 2. Each registrant need only comply with para graph 1 for items of information specified in Article 10(a)(iv), (vi), (vii) and (ix) that are required for the purposes of registration within his tonnage band in accordance with Article 12.

104. L 396/104 EN Official Journal of the European Union 30.12.2006 Article 29 Substance Information Exchange Fora 1. All potential registrants, downstream us ers and third parties who have submitted information to the Agency in accordance with Article 28, or whose information is held by the Agency in accordance with Article 15, for the same phase-in substance, or registrants who have submitted a registration for that phase-in substance before the deadline set out in Article 23(3), shall be participants in a s ubstance information exchange forum (SIEF). 2. The aim of each SIEF shall be to: (a) facilitate, for the purposes of registrati on, the exchange of the information specified in Article 10(a) (vi) and (vii) between pot ential registrants, thereby avoiding the duplication of studies; and (b) agree classification and labelling where th ere is a difference in the classification and labelling of the substance between potential registrants.

113. 30.12.2006 EN Official Journal of the European Union L 396/113 Article 33 Duty to communicate informati on on substances in articles 1. Any supplier of an article containing a subs tance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the arti cle including, as a minimum, the name of that substance. 2. On request by a consumer any supplier of an article containing a substance meeting the criteria in Article 57 and identified in acco rdance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the consumer with sufficient information, available to the supplier, to al low safe use of the article including, as a minimum, the name of that substance. The relevant information shall be provided, free of charge, within 45 days of receipt of the request. Article 34 Duty to communicate information on substances and preparations up the supply chain Any actor in the supply chain of a substance or a preparation shall communicate the following information to the next actor or distributor up th e supply chain: (a) new information on hazardous properties, regardless of the uses concerned;

114. L 396/114 EN Official Journal of the European Union 30.12.2006 (b) any other information that might call into question the appropriateness of the risk management measures identified in a safety data sheet supplied to him, which shall be communicated only for identified uses. Distributors shall pass on that information to the next actor or distributor up the supply chain. Article 35 Access to information for workers Workers and their representatives shall be gr anted access by their employer to the information provided in accordance with Articles 31 and 32 in rela tion to substances or preparations that they use or may be exposed to in the course of their work. Article 36 Obligation to keep information 1. Each manufacturer, importer, downstream user and distributor shall assemble and keep available all the information he requires to carry out his dut ies under this Regulation for a period of at least 10 years af ter he last manufactured, imported, supplied or used the substance or preparation. That manufacturer, im porter, downstream user or distributor shall submit this information or make it available without delay upon request to any competent authority of the Member State in which he is established or to the Agency, without prejudice to Titles II and VI.

134. L 396/134 EN Official Journal of the European Union 30.12.2006 2. If a registrant has ceased the manufacture or import of the substance, or the production or import of an article, or the downstream user the use, he shall inform the Agency of this fact with the consequence that the registered volume in his regist ration, if appropr iate, shall be put to zero and no further information may be requested with respect to that substance, unless the registrant notifies th e restart of the manufacture or import of the substance or the production or import of the article, or the downs tream user notifies the restart of the use. The Agency shall inform the competent auth ority of the Member State in which the registrant or downstream user is located. 3. The registrant may cease the manufacture or import of the substance or the production or import of the article, or the downstream user the use, upon receipt of the draft decision. In such cases, the registrant, or downstream user, sh all inform the Agency of this fact with the consequence that his registration, or report, shall no longer be valid, and no further information may be requested with respect to that substance, unless he submits a new registration or report. The Ag ency shall inform the compet ent authority of the Member State in which the registrant or downstream user is located. 4. Notwithstanding paragraphs 2 and 3, further information may be required in accordance with Article 46 in either or both of the following cases: (a) where the competent authority prepares a dossier in accordance with Annex XV concluding that there is a potential long-term risk to human health or the environment justifying the need for further information;

136. L 396/136 EN Official Journal of the European Union 30.12.2006 5. The Agency shall forthwith communicate any pr oposal for amendment to any registrants or downstream users concerned and allow them to comment within 30 days. The Member State Committee shall take any co mments received into account. 6. If, within 60 days of the referral, th e Member State Committee reaches a unanimous agreement on the draft decision, the Agen cy shall take the decision accordingly. 7. If the Member State Committee fails to reach unanimous agreement, the Commission shall prepare a draft decision to be taken in acco rdance with the procedure referred to in Article 133(3). 8. An appeal may be brought, in accordance with Articles 91, 92 and 93, against Agency decisions under paragraphs 3 and 6 of this Article. Article 52 Adoption of decisions under substance evaluation 1. The competent authority shall circulate its dr aft decision in accordance with Article 46, together with any comments by the registrant or downstream user, to the Agency and to the competent authorities of the other Member States. 2. The provisions of Article 51(2) to (8) shall apply mutatis mutandis .

158. L 396/158 EN Official Journal of the European Union 30.12.2006 Article 63 Subsequent applications for authorisation 1. If an application has been made for a use of a substance, a subsequent applicant may refer to the appropriate parts of the previous application submitted in accordance with Article 62(4)(d), (e) and (f) and (5)(a), pr ovided that the subsequent applicant has permission from the previous applicant to refer to these parts of the application. 2. If an authorisation has been granted for a use of a substanc e, a subsequent applicant may refer to the appropriate parts of the previ ous application submitted in accordance with Article 62(4)(d), (e) and (f) and (5)(a), pr ovided that the subsequent applicant has permission from the holder of the authorisation to refer to these part s of the application. 3. Before referring to any prev ious application in accordance with paragraphs 1 and 2, the subsequent applicant shall update the information of the origin al application as necessary. Article 64 Procedure for authorisation decisions 1. The Agency shall acknowledge the date of receipt of the app lication. The Agency's Committees for Risk Assessment and Socio-eco nomic Analysis shall give their draft opinions within ten months of the da te of receipt of the application.

170. L 396/170 EN Official Journal of the European Union 30.12.2006 Article 72 Submission of an opinion to the Commission 1. The Agency shall submit to the Commission without delay the opini ons of the Committees for Risk Assessment and Socio-economic Analysis on restrictions suggested for substances on their own, in preparations or in article s. If one or both of the Committees do not formulate an opinion by the deadline set in Ar ticle 70 and Article 71(1) the Agency shall inform the Commission accordingly, stating the reasons. 2. Without prejudice to Articles 118 and 119 the Agency shall publish the opinions of the two Committees on its website without delay. 3. The Agency shall provide the Commission and/or Member State on request with all documents and evidence submitted to or considered by it. Article 73 Commission decision 1. If the conditions laid down in Article 68 ar e fulfilled, the Commission shall prepare a draft amendment to Annex XVII, within three m onths of receipt of the opinion of the Committee for Socio-economic Analysis or by the end of the deadline established under Article 71 if that Committee does not fo rm an opinion, whichever is the earlier.

181. 30.12.2006 EN Official Journal of the European Union L 396/181 3. The duration of the term of office shall be f our years. The term of office may be renewed once. However, for the first mandate, the Comm ission shall identify half of its appointees, and the Council shall identify 12 of its appointees, for whom this period shall be six years. Article 80 Chairmanship of the Management Board 1. The Management Board shall elect a Chai rman and a Deputy-Chairman from among the members with voting rights. The Deputy-Chairm an shall automatically take the place of the Chairman if he is prevented from attending to his duties. 2. The terms of office of the Chairman and the Deputy-Chairman shall be two years and shall expire when they cease to be members of th e Management Board. The term of office shall be renewable once. Article 81 Meetings of the Management Board 1. The meetings of the Management Board shall be convened by invitation of its Chairman or at the request of at least one third of the Board members. 2. The Executive Director shall take part in the meetings of the Management Board, without voting rights.

182. L 396/182 EN Official Journal of the European Union 30.12.2006 3. The Chairmen of the Committees and the Ch airman of the Forum, as referred to in Article 76(1)(c) to (f), are entitled to a ttend the meetings of the Management Board without voting rights. Article 82 Voting of the Management Board The Management Board shall adopt rules of pr ocedure for voting, includi ng the conditions for a member to vote on behalf of another member. The Management Board shall act by a two-thirds majority of all me mbers with the right to vote. Article 83 Duties and powers of the Executive Director 1. The Agency shall be managed by its Executiv e Director, who shall perform his duties in the interests of the Comm unity, and independently of any specific interests. 2. The Executive Director shall be the legal representative of the Agency. He shall be responsible for: (a) the day-to-day administration of the Agency; (b) managing all the Agency resources necessary for carryi ng out its tasks; (c) ensuring that the time-limits laid down in Community legislation for the adoption of opinions by the Agency are complied with;

192. L 396/192 EN Official Journal of the European Union 30.12.2006 Article 88 Qualification and interests 1. The membership of the Committees and of the Forum shall be made public. Individual members may request that their names not be made public if they believe that such publication could place them at risk. The Executi ve Director shall deci de whether to agree to such requests. When each appointment is published, the professiona l qualifications of each member shall be specified. 2. Members of the Management Board, th e Executive Director and members of the Committees and of the Forum shall make a decl aration of commitment to fulfil their duties and a declaration of interests which could be considered to be prejudicial to their independence. These declarations shall be ma de annually in writing and, without prejudice to paragraph 1, be entered in a register he ld by the Agency which is accessible to the public, on request, at the Agency's offices. 3. At each of their meetings, members of th e Management Board, the Executive Director, members of the Committees and of the Forum an d any experts participating in the meeting shall declare any interests which could be considered to be pr ejudicial to their independence with respect to any points on the agenda. Anyone declaring such interests shall not participate in any voti ng on the relevant agenda point. Article 89 Establishment of the Board of Appeal 1. The Board of Appeal shall consist of a Chairman and two other members.

195. 30.12.2006 EN Official Journal of the European Union L 396/195 Article 91 Decisions subject to appeal 1. An appeal may be brought against decisions of the Agency taken pursuant to Article 9, Article 20, Article 27(6), Article 30(2) and (3) a nd Article 51. 2. An appeal lodged pursuant to paragraph 1 shall have suspensive effect. Article 92 Persons entitled to appeal, time-limits, fees and form 1. Any natural or legal person may appeal agai nst a decision addressed to that person, or against a decision which, although addressed to another person, is of direct and individual concern to the former. 2. The appeal, together with the statements of th e grounds thereof, shall be filed in writing to the Agency within three months of the notification of the d ecision to the person concerned, or in the absence thereof, of the day on which it became known to the latter, unless otherwise provided in this Regulation. 3. A fee may be payable by persons bringing an appeal against an Agency decision, in accordance with Title IX.

196. L 396/196 EN Official Journal of the European Union 30.12.2006 Article 93 Examination and decisions on appeal 1. If, after consultation with the Chairman of the Board of Appeal, the Executive Director considers the appeal to be admissible and we ll founded he may rectify the decision within 30 days of the appeal being filed in accordance with Article 92(2). 2. In cases other than those referred to in para graph 1 of this Article, the Chairman of the Board of Appeal shall examine whether the ap peal is admissible within 30 days of the appeal being filed in accordance with Article 92( 2). In the affirmative, the appeal shall be remitted to the Board of Appeal for examination of the grounds. Parties to the appeal proceedings shall be entitled to make an oral presentation during the procedure. 3. The Board of Appeal may exercise any power which lies within the competence of the Agency or remit the case to the compet ent body of the Agency for further action. 4. The procedures for the Board of Appeal shall be determined by the Commission in accordance with the procedure referred to in Article 133(3). Article 94 Actions before the Court of First Instance and the Court of Justice 1. An action may be brought before the Court of First Instance or the Court of Justice, in accordance with Article 230 of the Treaty, contesting a deci sion taken by the Board of Appeal or, in cases where no right of a ppeal lies before the Board, by the Agency.

203. 30.12.2006 EN Official Journal of the European Union L 396/203 Article 100 Legal personality of the Agency 1. The Agency shall be a body of the Community and shall have legal personality. In each Member State it shall enjoy the most extens ive legal capacity accorded to legal persons under their laws. In particular it may acqui re and dispose of movable and immovable property and may be a party to legal proceedings. 2. The Agency shall be represented by its Executive Director. Article 101 Liability of the Agency 1. The contractual liability of the Agency shal l be governed by the law applicable to the contract in question. The Court of Justice shal l have jurisdiction pursuant to any arbitration clause contained in a contra ct concluded by the Agency. 2. In the case of non-contractual liability, the Agency shall, in accordance with the general principles common to the laws of the Memb er States, make good any damage caused by it or by its servants in the performance of their duties. The Court of Justice shall have jurisdiction in any dispute relating to compensation for such damages.

204. L 396/204 EN Official Journal of the European Union 30.12.2006 3. The personal financial and disciplinary liability of its servants towards the Agency shall be governed by the relevant rules appl ying to the staff of the Agency. Article 102 Privileges and immunities of the Agency The Protocol on the Privileges and Immunities of the European Communities shall apply to the Agency. Article 103 Staff rules and regulations 1. The staff of the Agency shall be subject to th e Regulations and Rules applicable to officials and other servants of the European Communities. In respect of its staff, the Agency shall exercise the powers which have been devolved to the appointing authority. 2. The Management Board shall, in agreemen t with the Commission, adopt the necessary implementing provisions. 3. The Agency's staff shall consist of official s assigned or seconded by the Commission or Member States on a temporary basis and of other servants recruited by the Agency as necessary to carry out its tasks. The Agency shall recruit its personnel on the basis of a staffing plan to be included in the mu lti-annual work programme referred to in Article 78(d).

220. L 396/220 EN Official Journal of the European Union 30.12.2006 Article 123 Communication to the public of in formation on risks of substances The competent authorities of the Member States shall inform the general public about the risks arising from substances where this is considered necessary for the protection of human health or the environment. The Agency, in consultation with co mpetent authorities and stakeholders and drawing as appropriate on relevant best practice, sh all provide guidance for the communication of information on the risks and safe use of chemical substances, on their own, in preparations or in articles, with a view to coordinating Member States in these activities. Article 124 Other responsibilities Competent authorities shall submit electronically to the Agency any available information that they hold on substances registered in accordance with Article 12(1) whose dossiers do not contain the full information referred to in Annex VII, in part icular whether enforcement or monitoring activities have identified suspicions of risk. The compet ent authority shall update this information as appropriate. Member States shall establish national helpdesk s to provide advice to manufacturers, importers, downstream users and any other interested pa rties on their respectiv e responsibilities and obligations under this Regulation, in particular in relation to the registration of substances in accordance with Article 12(1), in addition to the operational gui dance documents provided by the Agency under Article 77(2)(g).

224. L 396/224 EN Official Journal of the European Union 30.12.2006 3. If, in the case of a decision as referred to in point (a) of paragraph 2, the provisional measure taken by the Member State consists in a restriction on the placing on the market or use of a substance, the Member State concer ned shall initiate a Community restrictions procedure by submitting to the Agency a dossier, in accordance with Annex XV, within three months of the date of the Commission decision. 4. In the case of a decision as referred to in point (a) of paragraph 2, the Commission shall consider whether this Regulation needs to be adapted. Article 130 Statement of reasons for decisions The competent authorities, the Agency and the Commission shall state the reasons for all decisions they take under this Regulation. Article 131 Amendments to the Annexes The Annexes may be amended in accordance with the procedure referred to in Article 133(4).

225. 30.12.2006 EN Official Journal of the European Union L 396/225 Article 132 Implementing legislation The measures necessary to put the provisions of th is Regulation efficiently into effect shall be adopted in accordance with the proc edure referred to in Article 133(3). Article 133 Committee procedure 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragra ph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the pr ovisions of Article 8 thereof. 3. Where reference is made to this paragra ph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the pr ovisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC sh all be set at three months. 4. Where reference is made to this paragra ph, Article 5a (1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 5. The Committee shall adopt its Rules of Procedure.

246. L 396/246 EN Official Journal of the European Union 30.12.2006 1.3.2. If the information is inadequa te to decide whether a substa nce should be classified for a particular end-point, the regist rant shall indicate and justif y the action or decision he has taken as a result. 1.4. Step 4: Identification of DNEL(s) 1.4.1. Based on the outcomes of steps 1 and 2, (a ) DNEL(s) shall be established for the substance, reflecting the likel y route(s), duration and frequency of exposure. For some endpoints, especially mutagenicity and carci nogenicity, the available information may not enable a threshold, and therefore a DNEL, to be established. If justified by the exposure scenario(s), a single DNEL may be sufficient. However, taking into account the available information and the exposure scenario(s) in Se ction 9 of the Chemical Safety Report it may be necessary to identify different DN ELs for each relevant human population (e.g. workers, consumers and humans liable to exposure indirectly via the environment) and possibly for certain vulne rable sub-populations (e.g. child ren, pregnant women) and for different routes of exposure. A full justification shall be given specifying, inter alia , the choice of the information used, the route of exposure (oral, dermal, inhalation) and the duration and frequency of exposure to the subs tance for which the DNEL is valid. If more than one route of exposure is likely to occu r, then a DNEL shall be established for each route of exposure and for the exposure from all routes combined. When establishing the DNEL, the following factors shall, inter alia , be taken into account:

325. 30.12.2006 EN Official Journal of the European Union L 396/325 8. TOXICOLOGICAL INFORMATION COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 8.1. Skin irritation or skin corrosion 8.1. Steps 3 and 4 do not need to be conducted if: The assessment of this endpoint shall comprise the following consecutive steps: (1) an assessment of the available human and animal data, (2) an assessment of the acid or alkaline reserve, (3) in vitro study for skin corrosion, (4) in vitro study for skin irritation. – the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes; or – the substance is flammable in air at room temperature; or – the substance is classified as very toxic in contact with skin; or – an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2 000 mg/kg body weight).

328. L 396/328 EN Official Journal of the European Union 30.12.2006 9. ECOTOXICOLOGICAL INFORMATION COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 9.1. Aquatic toxicity 9.1.1. Short-term toxicity testing on invertebrates (preferred species Daphnia) The registrant may consider long-term toxicity testing instead of short-term. 9.1.1. The study does not need to be conducted if: – there are mitigating factors indicating th at aquatic toxicity is unlikely to occur, for instance if the s ubstance is highly insoluble in water or the substance is unlikely to cross biological membranes; or – a long-term aquatic toxicity study on invertebrates is available; or – adequate information for environmental classification and labelling is available. The long-term aquatic toxicity study on Daphnia (Annex IX, section 9.1.5) shall be considered if the substance is poorly water soluble. 9.1.2. Growth inhibition study aquatic plants (algae preferred) 9.1.2. The study does not need to be conducted if there are mit igating factors indicating that aquatic toxicity is unlikely to occur for instan ce if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes.

6. L 396/6 EN Official Journal of the European Union 30.12.2006 (13) This Regulation should apply without prejudi ce to the prohibitions a nd restrictions laid down in Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products 1 in so far as substances are used and marketed as cosmetic ingredients and are with in the scope of this Regulation. A phase-out of testing on vertebrate animals for the purpos e of protecting human h ealth as specified in Directive 76/768/EEC should take place with rega rd to the uses of those substances in cosmetics. (14) This Regulation will generate informa tion on substances and their uses. Available information, including that ge nerated by this Regulation, shoul d be used by the relevant actors in the application and implementation of appropriate Community legislation, for example that covering products, and Commun ity voluntary instruments, such as the eco-labelling scheme. The Commission should cons ider in the review and development of relevant Community legisla tion and voluntary instruments how information generated by this Regulation should be used, and examine possibilities for establishing a European quality mark. 1 OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2005/80/EC (OJ L 303, 22.11.2005, p. 32).

33. 30.12.2006 EN Official Journal of the European Union L 396/33 (107) The Agency should be financed partly by f ees paid by natural or le gal persons and partly by the general budget of the European Communities. The Community budgetary procedure should remain applicable as far as any subsidies charg eable to the general budget of the European Communities are con cerned. Moreover, the auditing of accounts should be undertaken by the Court of A uditors in accordance with Article 91 of Commission Regulation (EC, Eurato m) No 2343/2002 of 23 December 2002 on the framework Financial Regulation for th e bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities 1 . (108) Where the Commission and Agency consid er it appropriate, it s hould be possible for representatives of third c ountries to participate in the work of the Agency. (109) The Agency should contribute, through coope ration with organisations having interests in the harmonisation of internati onal regulations, to the role of the Community and the Member States in such harmonisation activitie s. To promote broad in ternational consensus the Agency should take account of existing a nd emerging international standards in the regulation of chemicals such as the Globally Harmonised System ( GHS) of classification and labelling of chemicals. (110) The Agency should provide the infrastructure needed for natural or legal persons to meet their obligations under the data-sharing provisions. 1 OJ L 357, 31.12.2002, p. 72.

40. L 396/40 EN Official Journal of the European Union 30.12.2006 (129) For the sake of consistency, Directiv e 1999/45/EC which already addresses matters covered by this Regulation should be amended. (130) Since the objectives of this Regulati on, namely laying down rules for substances and establishing a European Chemicals Agenc y, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the princi ple of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is nece ssary in order to achieve those objectives. (131) The Regulation observes the fundamental rights and principl es which are acknowledged in particular in the Charter of Fundame ntal Rights of the European Union 1 . In particular, it seeks to ensure full compliance with the pr inciples of environmental protection and sustainable development guaranteed by Article 37 of that Charter, HAVE ADOPTED THIS REGULATION: 1 OJ C 364, 18.12.2000, p. 1.

92. L 396/92 EN Official Journal of the European Union 30.12.2006 (a) any change in his status, such as being a manufacturer, an importer or a producer of articles, or in his identity, such as his name or address; (b) any change in the composition of the subs tance as given in section 2 of Annex VI; (c) changes in the annual or total quantitie s manufactured or imported by him or in the quantities of substances present in artic les produced or imported by him if these result in a change of tonnage band, in cluding cessation of manufacture or import; (d) new identified uses and new uses advised against as in section 3.7 of Annex VI for which the substance is ma nufactured or imported; (e) new knowledge of the risks of the substan ce to human health and/or the environment of which he may reasonably be expected to have become aware which leads to changes in the safety data sheet or the chemical safety report; (f) any change in the classificati on and labelling of the substance; (g) any update or amendment of the chemical safety report or section 5 of Annex VI; (h) the registrant identifies the need to perfor m a test listed in Annex IX or Annex X, in which cases a testing propos al shall be developed; (i) any change in the access granted to information in the registration. The Agency shall communicate this information to the competent author ity of the relevant Member State.

102. L 396/102 EN Official Journal of the European Union 30.12.2006 2. The information referred to in paragraph 1 shall be submitted within a time period starting on 1 June 2008 and ending on 1 December 2008. 3. Registrants who do not submit the information required under paragraph 1 shall not be able to rely on Article 23. 4. The Agency shall by 1 January 2009 publish on it s website a list of th e substances referred to in paragraph 1(a) and (d). That list shall comprise only the names of the substances, including their EINECS and CAS number if av ailable and other identity codes, and the first envisaged registration deadline. 5. After the publication of the lis t a downstream user of a substance not appearing on the list may notify the Agency of his interest in the s ubstance, his contact deta ils and the details of his current supplier. The Agency shall publish on its website the name of the substance and on request provide contact details of the dow nstream user to a potential registrant.

140. L 396/140 EN Official Journal of the European Union 30.12.2006 2. A downstream user may use a substance m eeting the criteria set out in paragraph 1 provided that the use is in accordance with the conditions of an author isation granted to an actor up his supply chain for that use. 3. Paragraphs 1 and 2 shall not apply to the use of substances in scientific research and development. Annex XIV shall specify if para graphs 1 and 2 apply to product and process orientated research and development as well as the maximum quantity exempted. 4. Paragraphs 1 and 2 shall not apply to the following uses of substances: (a) uses in plant protection products wi thin the scope of Directive 91/414/EEC; (b) uses in biocidal products within the scope of Directive 98/8/EC; (c) use as motor fuels covered by Directive 98/ 70/EC of the European Parliament and of the Council of 13 October 1998 relating to th e quality of petrol and diesel fuels 1 ; (d) uses as fuel in mobile or fixed combus tion plants of mineral oil products and use as fuels in closed systems. 5. In the case of substances that are subject to authorisation only because they meet the criteria in Article 57(a), (b) or (c) or because they are identified in accordance with Article 57(f) only because of hazards to human health, paragraphs 1 a nd 2 of this Article shall not apply to the following uses: (a) uses in cosmetic products within the scope of Directive 76/768/EEC; 1 OJ L 350, 28.12.1998, p. 58. Directive as am ended by Regulation (EC) No 1882/2003.

147. 30.12.2006 EN Official Journal of the European Union L 396/147 3. Any Member State may prepare a dossier in accordance with Annex XV for substances which in its opinion meet the cr iteria set out in Article 57 and forward it to the Agency. The dossier may be limited, if appropriate, to a reference to an entry in Annex I of Directive 67/548/EEC. The Agency shall make this dossier available within 30 days of receipt to the other Member States. 4. The Agency shall publish on its website a notice that an Annex XV dossier has been prepared for a substance. The Agency shall inv ite all interested parties to submit comments within a specified deadline to the Agency. 5. Within 60 days of circulation, the other Memb er States or the Agency may comment on the identification of the substance in relation to th e criteria in Article 57 in the dossier to the Agency. 6. If the Agency does not receive or make a ny comments, it shall include this substance on the list referred to in pa ragraph 1. The Agency may include this substance in its recommendations under Article 58(3). 7. When comments are made or received , the Agency shall refer the dossier to the Member State Committee within 15 days of the end of the 60-day period referred to in paragraph 5.

179. 30.12.2006 EN Official Journal of the European Union L 396/179 (f) developing an electronic in formation exchange procedure; (g) liaising with industry , taking particular account of th e specific needs of SMEs, and other stakeholders, including relevant in ternational organisations, as necessary; (h) examining proposals for restrictions w ith a view to advising on enforceability. Article 78 Powers of the Management Board The Management Board shall appoint the Executi ve Director pursuant to Article 84 and an accounting officer in accordance with Article 43 of Regulation (EC, Euratom) No 2343/2002. It shall adopt: (a) by 30 April each year, the general report of the Agency for the previous year; (b) by 31 October each year the work programme of the Agency for the coming year; (c) the final budget of the Agency pursuant to Ar ticle 96 before the beginning of the financial year, adjusting it, where necessary, according to the Community cont ribution and any other revenue of the Agency; (d) a multi-annual work programme, which shall be regularly revised. It shall adopt the internal rules and procedures of the Agency. These rules shall be made public. It shall perform its duties in relation to the Agency's budget pursuant to Articles 96, 97 and 103.

188. L 396/188 EN Official Journal of the European Union 30.12.2006 8. When preparing an opinion, each Committee sh all use its best endeavours to reach a consensus. If such a consensus cannot be reach ed, the opinion shall consist of the position of the majority of members, including thei r grounds. The minority position(s), including their grounds, shall also be published. 9. Each Committee shall draft a proposal for its own rules of procedure, to be approved by the Management Board, within six months of the Committees first being appointed. These rules shall in particular lay down the procedures for replacing members, the procedures for delegating certain tasks to working groups, the creation of working groups and the establishment of a procedure for the urgent adoption of opini ons. The Chairman of each Committee shall be an employee of the Agency. Article 86 Establishment of the Forum 1. Each Member State shall appoint, for a thr ee-year term, which shall be renewable, one member to the Forum. Members shall be chosen for their role and experience in enforcement of chemicals legisl ation and shall maintain relevant contacts with the Member State competent authorities. The Forum shall aim to have a broad range of relevant expertise among its members. To this end the Forum may coopt a maximum of five additional members chosen on the basis of their specific competence. These members sha ll be appointed for a te rm of three years, which shall be renewable. Members of the Ma nagement Board may not be members of the Forum.

237. 30.12.2006 EN Official Journal of the European Union L 396/237 ANNEX I GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS 0. INTRODUCTION 0.1. The purpose of this Annex is to set out how manufacturers and importers are to assess and document that the risks arising from the substance they manufacture or import are adequately controlled during manufacture and their own use( s) and that others further down the supply chain can adequately control the risks. This Annex shall also apply adapted as necessary to produ cers and importers of articles required to make a chemical safety assessment as part of a registration. 0.2. The chemical safety assessment shall be prep ared by one or more competent person(s) who have appropriate experience and received appr opriate training, includ ing refresher training. 0.3. The chemical safety assessment of a manuf acturer shall address the manufacture of a substance and all the identified uses. The chem ical safety assessment of an importer shall address all identified uses. The chemical safe ty assessment shall consider the use of the substance on its own (including any major impur ities and additives), in a preparation and in an article, as defined by the identified uses . The assessment shall consider all stages of the life-cycle of the substance resulting fr om the manufacture and identified uses. The chemical safety assessment shall be based on a comparison of the potential adverse effects of a substance with the known or reasonably foreseeable exposure of man and/or the environment to that substance taking into account implemented and recommended risk management measures and operational conditions.

251. 30.12.2006 EN Official Journal of the European Union L 396/251 3.2. Step 2: Classification and Labelling 3.2.1. The appropriate classification and labelling developed in ac cordance with the criteria in Directive 67/548/EEC shall be presented and justified. Where applicable Specific Concentration limits, resulting from th e application of Article 4(4) of Directive 67/548/EEC and Article s 4 to 7 of Directive 1999/45/ EC, shall be presented and, if they are not included in Annex I to Directive 67/548/EEC, justified. 3.2.2. If the information are inadequa te to decide whether a substa nce should be classified for a particular end-point, the regist rant shall indicate and justif y the action or decision he has taken as a result. 3.3. Step 3: Identification of the PNEC 3.3.1. Based on the available information, the PNEC for each environmental sphere shall be established. The PNEC may be calculated by applying an appropr iate assessment factor to the effect values (e.g. LC50 or NOEC). An a ssessment factor expresses the difference between effects values derived for a limited number of species from laboratory tests and the PNEC for the environmental sphere 1 . 3.3.2. If it is not possible to derive the PNEC, then this shall be cl early stated and fully justified. 1 In general, the more extensive the data and th e longer the duration of the tests, the smaller is the degree of uncertainty and th e size of the assessment factor. An assessment factor of 1 000 is typically applied to the lowest of three short term L(E)C50 values derived from species representing different tr ophic levels and a factor of 10 to the lowest of three long-term NOEC values derived from speci es representing different trophic levels.

283. 30.12.2006 EN Official Journal of the European Union L 396/283 Vapour pressure Relative density Solubility Water solubility Partition coefficient: n-octanol/water Viscosity Vapour density Evaporation rate 9.3. Other information Indicate other important safety parameters, su ch as, miscibility, fat solubility (solvent – oil to be specified), conductivity, melting point/melting range, gas group (useful for Directive 94/9/EC of the European Parlia ment and the Council of 23 March 1994 on the approximation of the laws of the Member St ates concerning equipment and protective systems intended for use in pot entially explosiv e atmospheres 1 ), auto-ignition temperature, etc. 1 OJ L 100, 19.4.1994, p. 1. Directive as amended by Regulation (EC) No 1882/2003.

297. 30.12.2006 EN Official Journal of the European Union L 396/297 EINECS No Name/Group CAS No 216-472-8 Calcium distearate, pure C 18 H 36 O 2.1/2 Ca 1592-23-0 231-147-0 Argon Ar 7440-37-1 231-153-3 Carbon C 7440-44-0 231-783-9 Nitrogen N 2 7727-37-9 31-791-2 Water, distilled, conductivity or of similar purity H 2 O 7732-18-5 231-955-3 Graphite C 7782-42-5 232-273-9 Sunflower oil Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, and oleic. (Helianthus annuus, Compositae ). 8001-21-6

348. L 396/348 EN Official Journal of the European Union 30.12.2006 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 8.6.2. Sub-chronic toxicity study (90-day), one species, rodent, male and female, most appropriate route of administration, having regard to the likely route of human exposure. 8.6.2. The sub-chronic toxicity study (90 days) does not need to be conducted if: – a reliable short-term toxicity study (28 days) is available showing severe toxicity effects according to the criteri a for classifying the substance as R48, for which the observed NOAEL-28 days, with the application of an appropriate uncertainty factor, allo ws the extrapolation towards the NOAEL-90 days for the same route of exposure; or – a reliable chronic toxicity study is available, provided that an appropriate species and route of administration were used; or – a substance undergoes immediate disint egration and there are sufficient data on the cleavage products (both for systemic effects and effects at the site of uptake); or – the substance is unreactive, insolubl e and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28-day "limit test", particularly if such a pattern is coupled with limited human exposure.

350. L 396/350 EN Official Journal of the European Union 30.12.2006 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 Testing by the inhalation route is appropriate if: – exposure of humans via inhalation is lik ely taking into account the vapour pressure of the substance and/or the possibility of e xposure to aerosols, particles or droplets of an inhalable size.

351. 30.12.2006 EN Official Journal of the European Union L 396/351 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 Further studies shall be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 in case of: – failure to identify a NOAEL in the 90 days study unless the reason for the failure to identify a NOAEL is absence of adverse toxic effects; or – toxicity of particular concern (e.g. serious/severe effects); or – indications of an effect for which th e available evidence is inadequate for toxicological and/or risk characterisation. In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity); or – particular concern regarding exposure (e .g. use in consumer products leading to exposure levels which are close to the dose levels at which toxicity to humans may be expected).

362. L 396/362 EN Official Journal of the European Union 30.12.2006 8. TOXICOLOGICAL INFORMATION COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 8.4. If there is a positive result in any of the in vitro genotoxicity studies in Annexes VII or VIII, a second in vivo somatic cell test may be necessary, depending on the quality and relevance of all the available data. If there is a positive result from an in vivo somatic cell study available, the potential for germ cell mutagenicity should be considered on the basis of all available data, including toxicokinetic evidence. If no clear conclusions about germ cell mutage nicity can be made, additional investigations shall be considered.

363. 30.12.2006 EN Official Journal of the European Union L 396/363 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 8.6.3. A long-term repeated toxicity study ( ≥ 12 months) may be proposed by the registrant or required by the Agency in accordance with Articles 40 or 41 if the frequency and duration of human exposure indicates that a l onger term study is appropriate and one of the following conditions is met: – serious or severe toxicity effects of particular concern were observed in the 28-day or 90-day study for which the available ev idence is inadequate for toxicological evaluation or risk characterisation; or – effects shown in substances with a clear re lationship in molecular structure with the substance being studied were not detected in the 28-day or 90-day study; or – the substance may have a dangerous proper ty that cannot be detected in a 90-day study.

392. L 396/392 EN Official Journal of the European Union 30.12.2006 ANNEX XVI SOCIO-ECONOMIC ANALYSIS This Annex outlines the information that may be addressed by those submitting a socio-economic analysis (SEA) with an applica tion for authorisation, as specified in Article 62(5)(a), or in connection with a proposed restriction, as specified in Article 69(6)(b). The Agency shall prepare guidance for the prepara tion of SEAs. SEAs, or contributions to them, shall be submitted in the format specified by the Agency in accordance with Article 111. However, the level of detail and scope of the SEA, or contributions to them, shall be the responsibility of the applicant for authorisation, or, in the cas e of a proposed restriction, the interested party. The information provided can ad dress the socio-economic impacts at any level. An SEA may include the following elements: – Impact of a granted or refused authorisati on on the applicant(s), or, in the case of a proposed restriction, the impact on industry (e .g. manufacturers and importers). The impact on all other actors in the supply chain, downs tream users and associated businesses in terms of commercial consequences such as impact on investment, research and development, innovation, one-off and opera ting costs (e.g. compliance, transitional arrangements, changes to existing processes, reporting and monitoring systems, installation of new technology, etc.) taking into account gene ral trends in the market and technology.

395. 30.12.2006 EN Official Journal of the European Union L 396/395 ANNEX XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 1. Polychlorinated terphenyls (PCTs) – Preparations, incl uding waste oils, with a PCT content higher than 0,005 % by weight. 1. Shall not be used. However, the following use of equipment, installations and fluids which were in service on 30 June 1986 shall continue to be permitted until they are disposed of or reach th e end of their service life: (a) closed-system electrical equipment transformers, resistors and inductors; (b) large condensers ( ≥ 1 kg total weight); (c) small condensers; (d) heat-transmitting fluids in closed-circuit heat-transfer installations; (e) hydraulic fluids for underground mining equipment.

440. L 396/440 EN Official Journal of the European Union 30.12.2006 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 51. The following phthalates (or other CAS- and EINECS numbers covering the substance): bis (2-ethylhexyl) phthalate (DEHP) CAS No 117-81-7 Einecs No 204-211-0 dibutyl phthalate (DBP) CAS No 84-74-2 Einecs No 201-557-4 benzyl butyl phthalate (BBP) CAS No 85-68-7 Einecs No 201-622-7 Shall not be used as substances or as constituents of prepara tions, at concentrations higher than 0,1 % by mass of the plasticised material, in toys and childcare articles 1 . Toys and childcare articles containing these phthalates in a concen tration higher than 0,1 % by mass of the plasticised material shall not be placed on the market. The Commission shall re-evaluate, by 16 January 2010, the measures provided for in relation to this point in the light of new scientific information on such substances and their substitutes, and if justified, these measures shall be modified accordingly. 1 For the purposes of this point "childcare article" shall mean any product intended to facilitate sleep, relaxation, hygiene, the feedi ng of children or sucking on the part of children.

449. 30.12.2006 EN Official Journal of the European Union L 396/449 Substances Index number EC number CAS number Notes 203-448-7 [1] 106-97-8 [1] Butane [containing ≥ 0,1 % Butadiene (203-450-8)] [1] Isobutane [containing ≥ 0,1 % Butadiene (203-450-8)] [2] 601-004-01-8 200-857-2 [2] 75-28-5 [2] C, S 1,3-Butadiene; buta-1,3-dien e 601-013-00-X 203-450-8 106-99-0 D Benzene 601-020-00-8 200-753-7 71-43-2 E Triethyl arsenate 601-067-00-4 427-700-2 15606-95-8 Vinyl chloride; chloroethyl ene 602-023-00-7 200-831-0 75-01-4 Bis (chloromethyl) ether 603-046-00-5 208-832-8 542-88-1 Chloromethyl methyl ether; chlorodimethyl ether 603-075-00-3 203-480-1 107-30-2

450. L 396/450 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes 2-Naphthylamine; beta-naphthyl amine 612-022-00-3 202-080-4 91-59-8 E Benzidine; 4,4 ′ -diaminobiphenyl; biphenyl-4,4 ′ -ylenediamine 612-042-00-2 202-199-1 92-87-5 E Salts of benzidine 612-070-00-5 Salts of 2-naphthylamine 612-071-00-0 209-030- 0[1] 210-313- 6[2] 553-00-4[1] 612-52-2[2] Biphenyl-4-ylamine; xenylamine; 4-aminobiphenyl 612-072-00-6 202-177-1 92-67-1 Salts of biphenyl-4-ylamine; salts of xenylamine; salts of 4-aminobiphenyl 612-073-00-1 Tar, coal; Coal tar (The by-product from the destructive distillation of coal. Almost black semisolid. A complex combination of aromatic hydro-carbons, phenolic compounds, nitrogen bases and thiophene.) 648-081-00-7 232-361-7 8007-45-2

499. 30.12.2006 EN Official Journal of the European Union L 396/499 Substances Index number EC number CAS number Notes Gases (petroleum), C 3-4 ; Petroleum gas (A complex combination of hydrocarbons produced by distillation of products from the cracking of crude oil. It consists of hydrocarbons having carbon numbers in the range of C 3 through C 4 , predominantly of propane and propylene, and boiling in the range of approximately − 51 °C to − 1 °C.) 649-177-00-1 268-629-5 68131-75-9 H, K Tail gas (petroleum), catalytic cracked distillate and catalytic cracked naphtha fractionation absorber; Petroleum gas (The complex combination of hydrocarbons from th e distillation of the products from catalytic cracked distillates and catalytic cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C 1 through C 4 .) 649-178-00-7 269-617-2 68307-98-2 H, K

506. L 396/506 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Alkanes, C 4-5 ; Petroleum gas 649-196-00-5 270-654-1 68475-60-5 H, K Fuel gases; Petroleum gas (A combination of light gases. It consists predominantly of hydrogen and/or low molecular weight hydrocarbons.) 649-197-00-0 270-667-2 68476-26-6 H, K Fuel gases, crude oi l of distillates; Petroleum gas (A complex combination of light gases produced by distillation of crude oil and by catalytic reforming of naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 and boiling in the range of approximately − 217 °C to − 12 °C.) 649-198-00-6 270-670-9 68476-29-9 H, K Hydrocarbons, C 3-4 ; Petroleum gas 649-199-00-1 270-681-9 68476-40-4 H, K Hydrocarbons, C 4-5 ; Petroleum gas 649-200-00-5 270-682-4 68476-42-6 H, K

507. 30.12.2006 EN Official Journal of the European Union L 396/507 Substances Index number EC number CAS number Notes Hydrocarbons, C 2-4 , C 3 -rich; Petroleum gas 649-201-00-0 270-689-2 68476-49-3 H, K Petroleum gases, liquefied; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of crude o il. It consists of hydrocarbons having carbon numbers predominantly in the range of C 3 through C 7 and boiling in the range of approximately − 40 °C to 80 °C.) 649-202-00-6 270-704-2 68476-85-7 H, K, S Petroleum gases, liquefied, sweetened; Petroleum gas (A complex combination of hydrocarbons obtained by subjecting liquefied petroleum gas mix to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C 3 through C 7 and boiling in the range of approximately − 40 °C to 80 °C.) 649-203-00-1 270-705-8 68476-86-8 H, K, S

518. L 396/518 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Methyl acrylamidomethoxyacetate (containing ≥ 0,1 % acrylamide) 607-190-00-X 401-890-7 77402-03-0 Methyl acrylamidoglycolate (containing ≥ 0,1 % acrylamide) 607-210-00-7 403-230-3 77402-05-2 Oxiranemethanol, 4-methylbenzene- sulfonate, (S)- 607-411-00-X 417-210-7 70987-78-9 Acrylonitrile 608-003-00-4 203-466-5 107-13-1 D,E 2-Nitropropane 609-002-00-1 201-209-1 79-46-9 2,4-Dinitrotoluene [1]; dinitrotoluene [2]; dinitrotoluene, technical grade 609-007-00-9 204-450-0 [1] 246-836-1 [2] 121-14-2 [1] 25321-14-6 [2] E 5-Nitroacenaphthene 609-037-00-2 210-025-0 602-87-9 2-Nitronaphthalene 609-038-00-8 209-474-5 581-89-5 4-Nitrobiphenyl 609-039-00-3 202-204-7 92-93-3 Nitrofen (ISO); 2,4- dichlorophenyl4- nitrophenyl ether 609-040-00-9 217-406-0 1836-75-5 2-Nitroanisole 609-047-00-7 202-052-1 91-23-6 2,6-Dinitrotoluene 609- 049-00-8 210-106-0 606-20-2 E 2,3-dinitrotoluene 609- 050-00-3 210-013-5 602-01-7 E 3,4-dinitrotoluene 609- 051-00-9 210-222-1 610-39-9 E 3,5-dinitrotoluene 609- 052-00-4 210-566-2 618-85-9 E Hydrazine-tri-nitromethane 609-053-00-X 414-850-9 – 2,5-dinitrotoluene 609- 055-00-0 210-581-4 619-15-8 E 2-Nitrotoluene 609-065-00-5 201-853-3 88-72-2 E Azobenzene 611-001-00-6 203-102-5 103-33-3 E

759. 30.12.2006 EN Official Journal of the European Union L 396/759 Substances Index number EC number CAS number Notes Cadmium chloride 048-008-00-3 233-296-7 10108-64-2 E Cadmium sulphate 048- 009-00-9 233-331-6 10124-36-4 E Butane [containing ≥ 0,1 % Butadiene (203-450-8)] [1] 203-448-7 [1] 106-97-8 [1] Isobutane [containing ≥ 0,1 % Butadiene (203- 450-8)] [2] 601-004-01-8 20-857-2 [2] 75-28-5 [2] C, S 1,3-Butadiene buta-1,3- diene 601-013-00-X 203-450-8 106-99-0 D Benzene 601-020-00-8 200-753-7 71-43-2 E Benzo[a]pyrene; benzo[d,e,f]chrysene 601-032-00-3 200-028-5 50-32-8 1,2-Dibromo-3- chloropropane 602-021-00-6 202-479-3 96-12-8 Ethylene oxide; oxirane 603-023-00-X 200-849-9 75-21-8 Propylene oxide; 1,2- epoxypropane; Methyloxirane 603-055-00-4 200-879-2 75-56-9 E 2,2'-Bioxirane; 1,2:3,4- diepoxybutane 603-060-00-1 215-979-1 1464-53-5

760. L 396/760 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Methyl acrylamidomethoxyacetate (containing ≥ 0,1 % acrylamide) 607-190-00-X 401-890-7 77402-03-0 Methyl acrylamidoglycolate (containing ≥ 0,1 % acrylamide) 607-210-00-7 403-230-3 77402-05-2 2-Nitrotoluene 609-065-00-5 201-853-3 88-72-2 E 4,4'-oxydianiline [1] and its salts p-aminophenyl ether [1] 612-199-00-7 202-977-0 [1] 101-80-4 [1] E Ethyleneimine; aziridine 613-001-00-1 205-793-9 151-56-4 Carbendazim (ISO) methyl benzimidazol-2- ylcarbamate 613-048-00-8 234-232-0 10605-21-7 Benomyl (ISO) methyl 1- (butylcarbamoyl)benzimida zol-2-ylcarbamate 613-049-00-3 241-775-7 17804-35-2

778. L 396/778 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gases (petroleum), catalytic cracking; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of the products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C 3 through C 5 .) 649-098-00-2 272-203-4 68783-64-2 H, K Gases (petroleum), C 2-4 , sweetened; Petroleum gas (A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers predominantly in the range of C 2 through C 4 and boiling in the range of approximately − 51 °C to − 34 °C.) 649-099-00-8 272-205-5 68783-65-3 H, K

242. L 396/242 EN Official Journal of the European Union 30.12.2006 0.11. When assessing the risk of the use of one or more substances incorporated into a special preparation (for instance alloys), the way the constituent substances are bonded in the chemical matrix shall be taken into account. 0.12. Where the methodology described in this Annex is not appropriate, details of alternative methodology used shall be explained and just ified in the chemical safety report. 0.13. Part A of the chemical safety report shall in clude a declaration that the risk management measures outlined in the relevant exposure scenarios for the manufacturer's or importer's own use(s) are implemented by the manufactur er or importer and that those exposure scenarios for the identified uses are communicat ed to distributors and downstream users in the safety data sheet(s). 1. HUMAN HEALTH HAZARD ASSESSMENT 1.0. Introduction 1.0.1. The objective of the human health hazard assessment shall be: – to determine the classification and labell ing of a substance in accordance with Directive 67/548/EEC; and – to derive levels of exposure to the su bstance above which humans should not be exposed. This level of exposure is known as the Derived No-Effect Level (DNEL).

249. 30.12.2006 EN Official Journal of the European Union L 396/249 3.0.3. For any environmental sphere, for which no eff ect information is available, the relevant section of the chemical safety report shall contain the senten ce "This information is not available". The justification, in cluding reference to any literature research carried out, shall be included in the technical dossier. For any environmental sphere for which information is available, but the manufacturer or importer beli eves that it is not necessary to conduct the hazard assessment, the manufacturer or im porter shall present a justification, with reference to pertinent information, under the relevant heading of the Chemical Safety Report (Section 7) and where required and in accordance with Article 31, summarised in the Safety Data Sheet under heading 12. 3.0.4. The hazard assessment shall comprise the fo llowing three steps, which shall be clearly identified as such in the Chemical Safety Report: Step 1: Evaluation of information Step 2: Classification and Labelling Step 3: Derivation of the PNEC. 3.1. Step 1: Evaluation of information 3.1.1. The evaluation of all available information shall comprise: – the hazard identification based on all available information, – the establishment of the quantitative dose (concentration) – response (effect) relationship.

275. 30.12.2006 EN Official Journal of the European Union L 396/275 4. FIRST AID MEASURES Describe the first-aid measures. Specify first whether immediate medical attention is required. The information on first aid shall be brief and easy to understand by the victim, bystanders and first-aiders. The symptoms and effects sh all be briefly summarised. The instructions shall indicate what is to be done on the spot in the case of an accident and whether delayed effects can be expected after exposure. Subdivide the information according to the different routes of exposure, i.e. inhalation, skin and eye contact and ingest ion, under different subheadings. Indicate whether professional assistance by a doctor is needed or advisable. For some substances or preparations it may be important to emphasise that special means to provide specific and immedi ate treatment shall be ava ilable at the workplace. 5. FIRE-FIGHTING MEASURES Refer to requirements for fighting a fire caused by the substance or preparation, or arising in its vicinity by indicating: – suitable extinguishing media, – extinguishing media which shall not be used for safety reasons,

281. 30.12.2006 EN Official Journal of the European Union L 396/281 (c) Eye protection Specify the type of eye protecti on equipment required such as: – safety glasses, safety goggles, face shield. (d) Skin protection If it is necessary to protect a part of th e body other than the hands, specify the type and quality of protection e quipment required, such as: – apron, boots and full protective suit. If necessary, indicate any additional skin protection measures and specific hygiene measures. 8.2.2. Environmental exposure controls Specify the information required by the employer to fulfil his commitments under Community environmental protection legislation. Where a chemical safety report is required, a summary of the risk management measures that adequately control exposure of the envir onment to the substance shall be given for the exposure scenarios set out in the annex to the Safety Data Sheet.

374. L 396/374 EN Official Journal of the European Union 30.12.2006 1.2. Weight of evidence There may be sufficient weight of evid ence from several independent sources of information leading to the assumption/conclu sion that a substance has or has not a particular dangerous property, while the in formation from each single source alone is regarded insufficient to support this notion. There may be sufficient weight of evidence fr om the use of newly developed test methods, not yet included in the test methods referred to in Article 13(3) or from an international test method recognised by the Commission or the Agen cy as being equivalent, leading to the conclusion that a substance has or ha s not a particular dangerous property. Where sufficient weight of evidence for the presence or absence of a particular dangerous property is available: – further testing on vertebrate animals for that property shall be omitted, – further testing not involving vertebrate animals may be omitted. In all cases adequate and reliable documentation shall be provided. 1.3. Qualitative or Quantitative struct ure-activity relationship ((Q)SAR) Results obtained from valid qualitative or quantitative structure-activity relationship models ((Q)SARs) may indicate the presence or absence of a certain dangerous property. Results of (Q)SARs may be used instead of testing when the following conditions are met:

412. L 396/412 EN Official Journal of the European Union 30.12.2006 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 22. Pentachlorophenol CAS No 87-86-5 EINECS No 201-778-6 and its salts and esters 1. Shall not be used in a concentration equal to or greater than 0,1 % by mass in substances or preparations placed on the market. 2. Transitional provisions: By way of derogation until 31 December 2008 France, Ireland, Portugal, Spain and the United Kingdom may chose not to apply this provis ion to substances and preparations intended for use in industrial installations not permitting the emission and/or discharge of pentachlorophenol (PCP) in quantities greater th an those prescribed by existing legislation: (a) in the treatment of wood. However, treated wood shall not be used: – inside buildings whether for decorative purposes or not, whatever their purpose (residence, employment, leisure), – for the manufacture and re-treatment of: (i) containers intended for growing purposes; (ii) packaging that may come into contact with raw materials, intermediate or finished products destined for human and/or animal consumption; (iii) other materials that may contaminate the products mentioned in (i) and (ii);

132. L 396/132 EN Official Journal of the European Union 30.12.2006 Article 48 Follow-up to substance evaluation Once the substance evaluation has been completed, the competent authority shall consider how to use the information obtained from this evaluation for the purposes of Article 59(3), Article 69(4) and Article 115(1). The competent authority shall inform the Agency of its conclusions as to whether or how to use the information obtained. Th e Agency shall in turn inform the Commission, the registrant and the competent aut horities of the other Member States. Chapter 3 Evaluation of intermediates Article 49 Further information on on-site isolated intermediates For on-site isolated intermediates that are used in strictly controlled condi tions, neither dossier nor substance evaluation shall apply. Ho wever, where the competent authority of the Member State in whose territory the site is located considers that a risk to human health or the environment, equivalent to the level of concern arising from the use of substances meeting the criteria in Article 57, arises from the use of an on-site isolat ed intermediate and that risk is not properly controlled, it may: (a) require the registrant to submit further inform ation directly related to the risk identified. This request shall be accompanied by a written justification;

208. L 396/208 EN Official Journal of the European Union 30.12.2006 Article 111 Formats and software for submission of information to the Agency The Agency shall specify formats and make them available free of charge, and software packages and make them available on its website for any submissions to the Agency. Member States, manufactures, importers, di stributors or downstream users shall use these formats and packages in their submissions to the Agency pursuant to this Regulation. In particular, the Agency shall make available software tools to facilitate the subm ission of all information relating to substances registered in accordance with Article 12(1). For the purposes of registration, the format of the t echnical dossier referred to in Article 10(a) shall be IUCLID. The Agency shall coordinate the fu rther development of this format with the Organisation for Economic Cooperation and Deve lopment to ensure maximum harmonisation. TITLE XI CLASSIFICATION AND LABELLING INVENTORY Article 112 Scope This Title shall apply to: (a) substances subject to registration;

222. L 396/222 EN Official Journal of the European Union 30.12.2006 Article 127 Report The report referred to in Article 117( 1) shall, in relation to enforcem ent, include the results of the official inspections, the monitori ng carried out, the penalties provi ded for and the other measures taken pursuant to Articles 125 and 126 during the pr evious reporting period. The common issues to be covered in the reports shall be agreed by th e Forum. The Commission shall make these reports available to the Agency and the Forum. TITLE XV TRANSITIONAL AND FINAL PROVISIONS Article 128 Free movement 1. Subject to paragraph 2, Member States sh all not prohibit, restrict or impede the manufacturing, import, placing on the market or use of a substance, on its own, in a preparation or in an article, falling within the scope of this Regulation, which complies with this Regulation and, where appropr iate, with Community acts adopted in implementation of this Regulation.

62. L 396/62 EN Official Journal of the European Union 30.12.2006 TITLE II REGISTRATION OF SUBSTANCES Chapter 1 General obligation to register and information requirements Article 5 No data, no market Subject to Articles 6, 7, 21 and 23, substances on thei r own, in preparations or in articles shall not be manufactured in the Community or placed on the market unless they have been registered in accordance with the relevant provisions of this Title wher e this is required. Article 6 General obligation to register substances on their own or in preparations 1. Save where this Regulation provides otherw ise, any manufacturer or importer of a substance, either on its own or in one or more preparation(s), in qua ntities of 1 tonne or more per year shall submit a registration to the Agency. 2. For monomers that are used as on-site isol ated intermediates or transported isolated intermediates, Articles 17 and 18 shall not apply.

162. L 396/162 EN Official Journal of the European Union 30.12.2006 Chapter 3 Authorisations in the supply chain Article 65 Obligation of holders of authorisations Holders of an authorisation, as well as downstrea m users referred to in Ar ticle 56(2) including the substances in a preparation, shall include the author isation number on the labe l before they place the substance or a preparation containing the substa nce on the market for an authorised use without prejudice to Directive 67/548/ EEC and Directive 1999/45/EC. This shall be done without delay once the authorisation number has been made pub licly available in accordance with Article 64(9). Article 66 Downstream users 1. Downstream users using a substance in acco rdance with Article 56(2) shall notify the Agency within three months of th e first supply of the substance. 2. The Agency shall establish and keep up to da te a register of down stream users who have made a notification in accordance with paragr aph 1. The Agency shall grant access to this register to the competent aut horities of the Member States.

173. 30.12.2006 EN Official Journal of the European Union L 396/173 TITLE X AGENCY Article 75 Establishment and review 1. A European Chemicals Agency is establishe d for the purposes of managing and in some cases carrying out the te chnical, scientific and administ rative aspects of this Regulation and to ensure consistency at Community level in relation to these aspects. 2. The Agency shall be subject to a review by 1 June 2012. Article 76 Composition 1. The Agency shall comprise: (a) a Management Board, which shall exercise the responsibilities se t out in Article 78; (b) an Executive Director, who shall exercise the responsibilities se t out in Article 83; (c) a Committee for Risk Assessment, which shall be responsible for preparing the opinion of the Agency on evaluations, appli cations for authoris ation, proposals for restrictions and proposals for classificati on and labelling under Title XI and any other questions that arise from the operati on of this Regulation relating to risks to human health or the environment;

219. 30.12.2006 EN Official Journal of the European Union L 396/219 TITLE XIII COMPETENT AUTHORITIES Article 121 Appointment Member States shall appoint the competent auth ority or competent authorities responsible for performing the tasks allotted to competent authorities under this Regulation and for cooperating with the Commission and the Agency in the impl ementation of this Regulation. Member States shall place adequate resources at the disposal of the competent authorities to enable them, in conjunction with any other available resources, to fulfil their tasks under this Regulation in a timely and effective manner. Article 122 Cooperation between competent authorities The competent authorities shall cooperate with each other in the performan ce of their tasks under this Regulation and shall give th e competent authorities of other Member States all the necessary and useful support to this end.

221. 30.12.2006 EN Official Journal of the European Union L 396/221 TITLE XIV ENFORCEMENT Article 125 Tasks of the Member States Member States shall maintain a syst em of official controls and othe r activities as appropriate to the circumstances. Article 126 Penalties for non-compliance Member States shall lay down th e provisions on penalties applicab le for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission no later than 1 December 2008 and shall notify it without delay of any subsequent amendment affecting them.

303. 30.12.2006 EN Official Journal of the European Union L 396/303 EINECS No Name/Group CAS No 270-298-7 Fatty acids, C 14-22 68424-37-3 270-304-8 Fatty acids, linseed-oil 68424-45-3 270-312-1 Glycerides, C 16-18 and C 18 - unsaturated. mono- and di- This substance is identified by SDA Substance Name: C 16 - C 18 and C 18 unsaturated alkyl and C 16 - C 18 and C 18 unsaturated dialkyl glyceride and SDA Reporting Number: 11-002-00. 68424-61-3 288-123-8 Glycerides, C 10-18 85665-33-4 292-771-7 Fatty acids, C 12-14 90990-10-6 292-776-4 Fatty acids, C 12-18 and C 18 -unsaturated. 90990-15-1 296-916-5 Fatty acids, rape-oil, erucic acid-low 93165-31-2

293. 30.12.2006 EN Official Journal of the European Union L 396/293 – further information (written referenc es and/or technical contact point), – sources of key data used to compile the Safety Data Sheet. For a revised Safety Data Sheet, indicate cl early the information, which has been added, deleted or revised (unless this has been indicated elsewhere).

394. L 396/394 EN Official Journal of the European Union 30.12.2006 – In the case of a proposed restriction or refuse d authorisation, the bene fits for human health and the environment as well as the social and economic benefits of the proposed restriction. For example, worker health, envi ronmental performance a nd the distribution of these benefits, for example, geographically, population groups. – An SEA may also address any other issue th at is considered to be relevant by the applicant(s) or interested party.

60. L 396/60 EN Official Journal of the European Union 30.12.2006 31) Restriction: means any conditi on for or prohibition of the ma nufacture, use or placing on the market; 32) Supplier of a substance or a preparation: means any ma nufacturer, importer, downstream user or distributor placing on the market a s ubstance, on its own or in a preparation, or a preparation; 33) Supplier of an article: means any producer or importer of an articl e, distributor or other actor in the supply chain placi ng an article on the market; 34) Recipient of a substance or a preparation: means a downstrea m user or a di stributor being supplied with a substance or a preparation; 35) Recipient of an article: means an industria l or professional user, or a distributor, being supplied with an article but does not include consumers; 36) SME: means small and medium-sized enterprises as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises 1 ; 37) Exposure scenario: means the set of conditi ons, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or impor ter controls, or recommends downstream users to control, exposures of humans and the environment. These exposure scenarios may cover one specific process or use or seve ral processes or us es as appropriate; 1 OJ L 124, 20.5.2003, p. 36.

77. 30.12.2006 EN Official Journal of the European Union L 396/77 Article 14 Chemical safety repor t and duty to apply and recommend risk reduction measures 1. Without prejudice to Article 4 of Directive 98/24/EC, a chemical sa fety assessment shall be performed and a chemical safety report completed for all substances subject to registration in accordance with this Chapter in quantities of 10 tonnes or more per year per registrant. The chemical safety report shall document the chemical safety assessment which shall be conducted in accordance with paragraphs 2 to 7 and with Annex I for either each substance on its own or in a preparation or in an article or a group of substances. 2. A chemical safety assessment in accordance wi th paragraph 1 need not be performed for a substance which is present in a preparation if the concentration of the substance in the preparation is less than the lo west of any of the following: (a) the applicable concentrations defi ned in the table of Article 3(3) of Directive 1999/45/EC; (b) the concentration limits given in Annex I to Dire ctive 67/548/EEC; (c) the concentration limits given in Pa rt B of Annex II to Directive 1999/45/EC;

105. 30.12.2006 EN Official Journal of the European Union L 396/105 3. SIEF participants shall provide other particip ants with existing studi es, react to requests by other participants for information, collectivel y identify needs for further studies for the purposes of paragraph 2(a) and arrange for such studies to be carried out. Each SIEF shall be operational until 1 June 2018. Article 30 Sharing of data involving tests 1. Before testing is carried out in order to m eet the information requirements for the purposes of registration, a SIEF particip ant shall inquire whether a re levant study is available by communicating within his SIEF. If a relevant st udy involving tests on vertebrate animals is available within the SIEF, a participant of that SIEF sha ll request that study . If a relevant study not involving tests on vert ebrate animals is availabl e within the SIEF, a SIEF participant may request that study . Within one month of the request , the owner of the study shall pr ovide proof of its cost to the participant(s) requesting it. The participant( s) and the owner shall make every effort to ensure that the costs of sharing the informa tion are determined in a fair, transparent and non discriminatory way. This may be facilita ted by following any cost sharing guidance which is based on those princi ples and is adopted by the Agency in accordance with Article 77(2)(g). If they cannot reach such an agreement, the cost shall be shared equally. The owner shall give permission to refer to the full study report for the purpose of registration within two weeks of receipt of payment. Registrants are only required to share in the costs of information that they are re quired to submit to satisfy their registration requirements.

201. 30.12.2006 EN Official Journal of the European Union L 396/201 5. On receipt of the Court of Auditors' obse rvations on the Agency's provisional accounts, pursuant to Article 129 of Regulation (EC, Euratom) No 1605/2002, the Executive Director shall draw up the Agency's fina l accounts under his own responsibility and forward them to the Management Board for an opinion. 6. The Management Board shall deliver an opinion on the Agency's final accounts. 7. By 1 July of the following year at the la test, the Executive Director shall send the final accounts, together with the opinion of the Mana gement Board, to the European Parliament, the Council, the Commission a nd the Court of Auditors. 8. The final accounts shall be published. 9. The Executive Director shall send the Court of Auditors a reply to its observations by 30 September at the latest. He shall also send this reply to the Management Board. 10. The European Parliament, upon a recommendation from the Council, shall, before 30 April of year N + 2, give a discharge to the Executiv e Director in respect of the implementation of the budget for year N. Article 98 Combating fraud 1. In order to combat fraud, corruption and ot her unlawful activities , the provisions of Regulation (EC) No 1073/1999 of the Europ ean Parliament and of the Council of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) 1 shall apply without rest rictions to the Agency. 1 OJ L 136, 31.5.1999, p. 1.

206. L 396/206 EN Official Journal of the European Union 30.12.2006 Article 107 Participation of international organisations The Management Board may, in agreement with the relevant Committee or the Forum, invite representatives of international or ganisations with interests in the field of chemicals regulation to participate as observers in the work of the Agency. Article 108 Contacts with stakeholder organisations The Management Board shall, in agreement with the Commission, develop appropriate contacts between the Agency and releva nt stakeholder organisations. Article 109 Rules on transparency To ensure transparency, the Management Board shall, on the basis of a proposal by the Executive Director and in agreement with th e Commission, adopt rules to ensure the availability to the public of regulatory, scientific or techni cal information concerning the safety of substances on their own, in preparations or in articles whic h is not of a conf idential nature.

209. 30.12.2006 EN Official Journal of the European Union L 396/209 (b) substances within the scope of Article 1 of Directive 67/548/EEC, which meet the criteria for classification as dangerous in accordance wi th that Directive, and which are placed on the market either on their own, or in a prepar ation above the concentr ation limits specified in Directive 1999/45/EC, where relevant, whic h results in the cl assification of the preparation as dangerous. Article 113 Obligation to notify the Agency 1. Any manufacturer, producer of articles or importer, or group of manufactur ers or producers of articles or importers, who place on the market a substance w ithin the scope of Article 112, shall notify to the Agency the fo llowing information in order for it to be included in the inventory in accordance with Article 114, unless submitted as part of the registration: (a) the identity(ies) of the manufacturer(s), producer(s) of articles or importer(s) responsible for placing the substance(s) on th e market as specifie d in section 1 of Annex VI; (b) the identity of the substa nce(s) as specified in sect ions 2.1 to 2.3.4 of Annex VI; (c) the hazard classification of the substa nce(s), resulting from the application of Articles 4 and 6 of Directive 67/548/EEC;

212. L 396/212 EN Official Journal of the European Union 30.12.2006 Article 115 Harmonisation of classification and labelling 1. Harmonised classification and labelling at Community level shall, from 1 June 2007, normally be added to Annex I of Directive 67/ 548/EEC for classificati on of a substance as carcinogenic, mutagenic or toxi c for reproduction category 1, 2 or 3, or as a respiratory sensitiser. Harmonised classification and labelling for other effects may also be added to Annex I of Directive 67/548/EEC on a case-by- case basis if justification is provided demonstrating the need for action at Community level. To this end, Member State competent authorities may submit proposals to the Agency for harmonised classification and labelling in accordance with Annex XV. 2. The Committee for Risk Assessment shall adopt an opinion on the proposal, giving parties concerned the opportunity to comment. The Ag ency shall forward this opinion and any comments to the Commission, which shall take a decision in accordance with Article 4(3) of Directive 67/548/EEC. Article 116 Transitional arrangements The obligations set out in Article 11 3 shall apply from 1 December 2010.

218. L 396/218 EN Official Journal of the European Union 30.12.2006 Article 120 Cooperation with third countries and international organisations Notwithstanding Articles 118 and 119, information received by the Agency under this Regulation may be disclosed to any government or national au thority of a third country or an international organisation in accordance with an agreemen t concluded between the Community and the third party concerned under Regul ation (EC) No 304/2003 of the European Parliament and of the Council of 28 January 2003 concerning the e xport and import of dangerous chemicals 1 or under Article 181a (3) of the Treaty, provided that both the following conditions are met: (a) the purpose of the agreement is cooperati on on the implementation or management of legislation concerning chemical s covered by this Regulation; (b) the third party protects the confiden tial information as mutually agreed. 1 OJ L 63, 6.3.2003, p. 1. Regulation as last amended by Commission Regulation (EC) No 775/2004 (OJ L 123, 27.4.2004, p. 27).

233. 30.12.2006 EN Official Journal of the European Union L 396/233 Article 139 Repeals Directive 91/155/EEC shall be repealed. Directives 93/105/EC and 2000/21/EC and Regul ations (EEC) No 793/93 and (EC) No 1488/94 shall be repealed with effect from 1 June 2008. Directive 93/67/EEC shall be repeal ed with effect from 1 August 2008. Directive 76/769/EEC shall be repeal ed with effect from 1 June 2009. References to the repealed acts shall be c onstrued as references to this Regulation. Article 140 Amendment of Directive 1999/45/EC Article 14 of Directive 1 999/45/EC shall be deleted. Article 141 Entry into force and application 1. This Regulation shall ente r into force on 1 June 2007. 2. Titles II, III, V, VI, VII, XI and XII as well as Articles 128 and 136 shall apply from 1 June 2008.

326. L 396/326 EN Official Journal of the European Union 30.12.2006 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 8.2. Eye irritation 8.2. Step 3 does not need to be conducted if: The assessment of this endpoint shall comprise the following consecutive steps: (1) an assessment of the available human and animal data, (2) an assessment of the acid or alkaline reserve, (3) in vitro study for eye irritation. – the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes; or – the substance is flammable in air at room temperature; 8.3. Skin sensitisation 8.3. Step 2 does not need to be conducted if: The assessment of this endpoint shall comprise the following consecutive steps: (1) an assessment of the available human, animal and alternative data, (2) In vivo testing. – the available information indicates that th e substance should be classified for skin sensitisation or corrosivity; or – the substance is a strong acid (pH < 2,0) or base (pH > 11,5); or – the substance is flammable in air at room temperature. The Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing. Only in exceptional circumstances should another test be used. Justification for the use of another test shall be provided.

331. 30.12.2006 EN Official Journal of the European Union L 396/331 Before new tests are carried out to determine th e properties listed in th is Annex, all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substa nces (read-across approach) shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shal l be avoided. Prior to testing, further guidance on testing strategies sh ould be consulted in addition to this Annex. When, for certain endpoints, information is not pr ovided for other reasons than those mentioned in column 2 of this Annex or in Annex XI, this f act and the reasons shall also be clearly stated.

345. 30.12.2006 EN Official Journal of the European Union L 396/345 Before new tests are carried out to determine th e properties listed in th is Annex, all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substa nces (read-across approach) shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shal l be avoided. Prior to testing, further guidance on testing strategies sh ould be consulted in addition to this Annex. When, for certain endpoints, it is proposed not to provide information for other reasons than those mentioned in column 2 of this Annex or in Annex XI , this fact and the reasons shall also be clearly stated.

361. 30.12.2006 EN Official Journal of the European Union L 396/361 Before new tests are carried out to determine th e properties listed in th is Annex, all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substa nces (read-across approach) shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shal l be avoided. Prior to testing, further guidance on testing strategies sh ould be consulted in addition to this Annex. When, for certain endpoints, it is proposed not to provide information for other reasons than those mentioned in column 2 of this Annex or in Annex XI , this fact and the reasons shall also be clearly stated.

38. L 396/38 EN Official Journal of the European Union 30.12.2006 (123) The measures necessary for the implementa tion of this Regulation and certain amendments to it should be adopted in accordance w ith Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission 1 . (124) In particular, power should be conferre d on the Commission to amend the Annexes in certain cases, to set rules on test methods, to vary the percentage of dossiers selected for compliance checking and to modi fy the criteria for their sele ction, and to se t the criteria defining what constitutes adequate justificati on that testing is technically not possible. Since these measures are of general scope and are designed to amend non-essential elements of this Regulation or supplemen t this Regulation by adding new non-essential elements thereto, they should be adopted in a ccordance with the regulatory procedure with scrutiny provided for in Artic le 5a of Decision 1999/468/EC. (125) It is essential that chem icals be regulated in an effec tive and timely manner during the transition to full applicability of the provision s of this Regulation and, in particular, during the start-up period of the Agency. Provision s hould therefore be made for the Commission to provide the necessary support towards th e setting up of the Agency, including the conclusion of contracts and the appoi ntment of an Executive Director ad interim until the Agency's Management Board can appoi nt an Executive Director itself. 1 OJ L 184, 17.7.1999, p. 23. Decision as am ended by Council Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).

79. 30.12.2006 EN Official Journal of the European Union L 396/79 (b) risk characterisation. The exposure scenarios (where appropriate the use and exposure categories), exposure assessment and risk characterisation shall addr ess all identified uses of the registrant. 5. The chemical safety report need not include consideration of the risks to human health from the following end uses: (a) in food contact materials within the scope of Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food 1 ; (b) in cosmetic products within the scope of Directive 76/768/EEC. 6. Any registrant shall identify and apply the appropriate measures to adequately control the risks identified in the chemical safety asse ssment, and where suitable, recommend them in the safety data sheets which he s upplies in accordan ce with Article 31. 7. Any registrant required to conduct a chemical safety assessm ent shall keep his chemical safety report available and up to date. 1 OJ L 338, 13.11.2004, p. 4.

135. 30.12.2006 EN Official Journal of the European Union L 396/135 (b) where the exposure to the substance manuf actured or imported by the registrant(s), or to the substance in the artic le produced or imported by the registrant(s), or to the substance used by the downstream user(s) contributes significantly to that risk. The procedure in Articles 69 to 73 shall apply mutatis mutandis . Article 51 Adoption of decisions un der dossier evaluation 1. The Agency shall notify its draft decision in accordance w ith Articles 40 or 41, together with the comments of the registrant, to the competent authorities of the Member States. 2. Within 30 days of circulation, the Member States may propose amendments to the draft decision to the Agency. 3. If the Agency does not receive any proposals, it shall take the decision in the version notified under paragraph 1. 4. If the Agency receives a proposal for amen dment, it may modify the draft decision. The Agency shall refer a draft decision, togeth er with any amendments proposed, to the Member State Committee within 15 days of th e end of the 30-day period referred to in paragraph 2.

202. L 396/202 EN Official Journal of the European Union 30.12.2006 2. The Agency shall be bound by the Interins titutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal i nvestigations by the European Anti-Fraud Office (OLAF) 1 and shall issue, without delay, the appropriate provi sions applicable to all of its staff. 3. The decisions concerning funding and the implementing agreements and instruments resulting from them shall explicitly stipulat e that the Court of A uditors and OLAF may carry out, if necessary, on-the-spot checks of the recipients of the Agency's funding and the agents responsible for allocating it. Article 99 Financial rules The financial rules applicable to the Agency sh all be adopted by the Mana gement Board after the Commission has been consulted. They may not depart from Regulation (EC, Euratom) No 2343/2002 unless specifically necessary for the Agency's operation and with the Commission's prior consent. 1 OJ L 136, 31.5.1999, p. 15.

289. 30.12.2006 EN Official Journal of the European Union L 396/289 12.3. Persistence and degradability The potential of the substance or the a ppropriate constituents of a preparation 1 to degrade in relevant environmental medi a, either through biodegradation or other processes such as oxidation or hydrolysis. Degrad ation half lives shall be quoted where available. The potential of the substance or appropr iate constituents of a preparation 1 to degrade in sewage treatment plants sh all also be mentioned. 12.4. Bioaccumulative potential The potential of the substance or the a ppropriate constituents of a preparation 1 to accumulate in biota and, eventually, to pass th rough the food chain, with reference to the octanol-water partition coefficient (Kow) and bi oconcentration factor (BCF), if available. 12.5. Results of PBT assessment Where a Chemical Safety Report is required, th e results of the PBT assessment as set in the Chemical Safety Report shall be given. 12.6. Other adverse effects If available, include information on any other adverse effects on the environment, e.g. ozone depletion potential, photochemi cal ozone creation potential, endocrine disrupting potential and/or global warming potential.

295. 30.12.2006 EN Official Journal of the European Union L 396/295 ANNEX IV EXEMPTIONS FROM THE OB LIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a) EINECS No Name/Group CAS No 200-061-5 D-glucitol C 6 H 14 O 6 50-70-4 200-066-2 Ascorbic acid C 6 H 8 O 6 50-81-7 200-075-1 Glucose C 6 H 12 O 6 50-99-7 200-294-2 L-lysine C 6 H 14 N 2 O 2 56-87-1 200-312-9 Palmitic acid, pure C 16 H 32 O 2 57-10-3 200-313-4 Stearic acid, pure C 18 H 36 O 2 57-11-4 200-334-9 Sucrose, pure C 12 H 22 O 11 57-50-1 200-405-4 α -tocopheryl acetate C 31 H 52 O 3 58-95-7 200-432-1 DL-methionine C 5 H 11 NO 2 S 59-51-8 200-711-8 D-mannitol C 6 H 14 O 6 69-65-8 201-771-8 1-sorbose C 6 H 12 O 6 87-79-6 204-007-1 Oleic acid, pure C 18 H 34 O 2 112-80-1

299. 30.12.2006 EN Official Journal of the European Union L 396/299 EINECS No Name/Group CAS No 232-293-8 Castor Oil Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acid ricinoleic (Ricinus communis, Euphorbiaceae). 8001-79-4 232-299-0 Rape oil Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids erucic, linoleic and oleic (Brassica napus, Cruciferae) . 8002-13-9 232-307-2 Lecithins The complex combination of diglycerides of fatty acids linked to the choline ester of phosphoric acid. 8002-43-5 232-436-4 Syrups, hydrolyzed starch A complex combination obtained by the hydrolysis of cornstarch by the action of acids or enzymes. It consists primarily of d-glucose, maltose and maltodextrins. 8029-43-4

306. L 396/306 EN Official Journal of the European Union 30.12.2006 ANNEX VI INFORMATION REQUIREMENTS RE FERRED TO IN ARTICLE 10 GUIDANCE NOTE ON FULFILLING THE REQUIREMENTS OF ANNEXES VI TO XI Annexes VI to XI specify the information that shall be submitted for re gistration and evaluation purposes according to Articles 10, 12, 13, 40, 41 and 46. For the lowest tonnage level, the standard requirements are in Annex VII, and every time a new tonnage level is reac hed, the requirements of the corresponding Annex have to be added. Fo r each registration the precise information requirements will differ, according to tonnage, use and exposure. The Annexes shall thus be considered as a whole, and in conjunction with the overall requirements of registration, evaluation and the duty of care. STEP 1 – GATHER AND SHARE EXISTING INFORMATION The registrant should gather all ex isting available test data on the substance to be registered, this would include a literature search for relevant in formation on the substance. Wherever practicable, registrations should be submitted jointly, in accordan ce with Articles 11 or 19. This will enable test data to be shared, thereby avoi ding unnecessary testing and reduci ng costs. The registrant should also collect all other available and relevant info rmation on the substance re gardless whether testing for a given endpoint is required or not at the specific tonnage level. This should include information from alternative sources (e.g. from (Q)SARs, read- across from other substances, in vivo and in vitro testing, epidemiological data) whic h may assist in identifying the presence or absence of hazardous properties of the substance and which can in cert ain cases replace the results of animal tests.

349. 30.12.2006 EN Official Journal of the European Union L 396/349 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 The appropriate route shall be chosen on the following basis: Testing by the dermal route is appropriate if: (1) skin contact in production and/or use is likely; and (2) the physicochemical properties suggest a significant rate of absorption through the skin; and (3) one of the following conditions is met: – toxicity is observed in the acute dermal t oxicity test at lower doses than in the oral toxicity test; or – systemic effects or other evidence of absorption is observed in skin and/or eye irritation studies; or – in vitro tests indicate significant dermal absorption; or – significant dermal toxicity or de rmal penetration is recognised for structurally-related substances.

352. L 396/352 EN Official Journal of the European Union 30.12.2006 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 8.7. Reproductive toxicity 8.7. The studies do not need to be conducted if: – the substance is known to be a ge notoxic carcinogen and appropriate risk management measures are implemented; or – the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented; or – the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure.

353. 30.12.2006 EN Official Journal of the European Union L 396/353 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 If a substance is known to have an a dverse effect on fertility, meeting the criteria for classification as Repr Cat 1 or 2: R60, and the available data are adequate to support a robust risk asse ssment, then no further testing for fertility will be necessary. However, testing for development toxicity must be considered. If a substance is known to cause deve lopmental toxicity, meeting the criteria for classification as Repr Cat 1 or 2: R61, and the available data are adequate to support a robust risk asse ssment, then no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered. 8.7.2. Pre-natal developmental toxicity study, one species, most appropriate route of administration, having regard to the likely route of human exposure (B.31 of the Commission Regulation on test methods as specified in Article 13(3) or OECD 414). 8.7.2. The study shall be initially performed on one species. A decision on the need to perform a study at this tonnage level or the next on a second species should be based on the outcome of the first test and all other relevant available data. 8.7.3. Two-generation reproductive toxicity study, one species, male and female, most appropriate route of administration, having regard to the likely route of human exposure, if the 28-day or 90-day study indicates adverse effects on reproductive organs or tissues. 8.7.3. The study shall be initially performed on one species. A decision on the need to perform a study at this tonnage level or the next on a second species should be based on the outcome of the first test and all other relevant available date.

383. 30.12.2006 EN Official Journal of the European Union L 396/383 ANNEX XIII CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSIS TENT AND VERY BIOACCUMULATIVE SUBSTANCES This Annex lays down the criteria for the identification of: (i) persistent, bioaccumulative and toxic substances (PBT-substances), and (ii) very persistent and very bioaccumulative substances (vPvB-substances). A substance is identified as a PB T substance if it fulfils the cr iteria in Sections 1.1, 1.2 and 1.3. A substance is identified as a vPvB substance if it fulfils the crit eria in Sections 2.1 and 2.2. This annex shall not apply to inorganic substa nces, but shall apply to organo-metals. 1. PBT-substances A substance that fulfils all three of the criter ia of the sections below is a PBT substance. 1.1. Persistence A substance fulfils the persistence criterion (P-) when: – the half-life in marine water is higher than 60 days, or – the half-life in fresh- or estuarin e water is higher than 40 days, or

388. L 396/388 EN Official Journal of the European Union 30.12.2006 II. CONTENT OF DOSSIERS 1. Dossier for harmonised classification and la belling for CMRs, respiratory sensitisers and other effects Proposal The proposal shall include the identity of the substance(s) concerned and the harmonised classification and labelling proposed. Justification A comparison of the available information with the criteria for CMRs, respiratory sensitisers and other effects on a case by cas e basis in Directive 67/548/EEC according to the relevant parts of Section 1 of Annex I sh all be completed and documented in the format set out in Part B of the Chemi cal Safety Report in Annex I. Justification for other effects at Community Level Justification shall be provided that there is a need for action demonstrated at Community Level

389. 30.12.2006 EN Official Journal of the European Union L 396/389 2. Dossier for the identification of a substan ce as a CMR, PBT, vPvB or a substance of equivalent concern according to Article 59 Proposal The proposal shall include the identity of substance(s) concerned and whether it is proposed to be identified as a CMR according to Article 57(a), (b) or (c), a PBT according to Article 57(d), a V P V B according to Article 57(e), or a substance of equivalent concern according to Article 57(f). Justification A comparison of the available informati on with the criteria in Annex XIII for PBT according to Article 57(d), and vPvBs according to Article 57(e), or an assessment of the hazards and a comparison with Article 57(f), accord ing to the relevant pa rts of Section 1 to 4 of Annex I shall be completed. This shall be documented in the format set out in Part B of the Chemical Safety Report in Annex I. Information on exposures, alte rnative substances and risks The available use and exposure information a nd information on altern ative substances and techniques shall be provided.

108. L 396/108 EN Official Journal of the European Union 30.12.2006 2. Any actor in the supply chain who is requi red, under Articles 14 or 37, to carry out a chemical safety assessment for a substance shal l ensure that the information in the safety data sheet is consistent with the information in this assessment. If the safety data sheet is developed for a preparation and the actor in the supply chain has prepared a chemical safety assessment for that preparation, it is su fficient if the information in the safety data sheet is consistent with the chemical safety report for the preparati on instead of with the chemical safety report for each substance in the preparation. 3. The supplier shall provide the recipient at his request with a safety data sheet compiled in accordance with Annex II, where a preparation do es not meet the criteria for classification as dangerous in accordance with Articles 5, 6 and 7 of Directive 1999/45/EC, but contains: (a) in an individual concentration of ≥ 1 % by weight for non-gaseous preparations and ≥ 0,2 % by volume for gaseous preparations at least one subs tance posing human health or environmental hazards; or (b) in an individual concentration of ≥ 0,1 % by weight for non-gaseous preparations at least one substance that is persistent, bi oaccumulative and toxic or very persistent and very bioaccumulative in accordance with th e criteria set out in Annex XIII or has been included for reasons other than thos e referred to in point (a) in the list established in accordance with Article 59(1);or (c) a substance for which there are Community workplace exposure limits.

247. 30.12.2006 EN Official Journal of the European Union L 396/247 (a) the uncertainty arising, among other factors, from the variability in the experimental information and from intra- and inter-species variation; (b) the nature and seve rity of the effect; (c) the sensitivity of the human (sub-)pop ulation to which the quantitative and/or qualitative information on exposure applies. 1.4.2. If it is not possible to identify a DNEL, then this shall be clearly stated and fully justified. 2. PHYSICOCHEMICAL HAZARD ASSESSMENT 2.1. The objective of the hazard assessment for physicochemical prope rties shall be to determine the classification and labelli ng of a substance in accordance with Directive 67/548/EEC. 2.2. As a minimum, the potential effects to human health shall be assessed for the following physicochemical properties: – explosivity, – flammability, – oxidising potential. If the information are inadequa te to decide whether a substa nce should be classified for a particular end-point, the regist rant shall indicate and justif y the action or decision he has taken as a result.

259. 30.12.2006 EN Official Journal of the European Union L 396/259 – the likely pathways to the environm ent and environmenta l distribution and degradation and/or transformation (see also Section 3 Step 1), – scale (geographical) of exposure, – matrix dependent release/mi gration of the substance. 5.2.5. Where adequately measured representative exposure data are available, special consideration shall be given to them when conducting the exposure assessment. Appropriate models can be used for the esti mation of exposure levels. Relevant monitoring data from substances with analogous use and ex posure patterns or analogous properties can also be considered. 6. RISK CHARACTERISATION 6.1. The risk characterisation shall be carried out for each exposure scenario and shall be presented under the relevant headi ng of the Chemical Safety Report. 6.2. The risk characterisation sh all consider the human populations (exposed as workers, consumers or indirectly via the environment a nd if relevant a combination thereof) and the environmental spheres for which exposure to the substance is known or reasonably foreseeable, under the assumption that the risk management measures described in the exposure scenarios in the Section 5 have been implemented. In addition, the overall environmental risk caused by the substance shal l be reviewed by integr ating the results for the overall releases, emissions and losses from all sources to all environmental compartments.

272. L 396/272 EN Official Journal of the European Union 30.12.2006 3. COMPOSITION/INFORMATION ON INGREDIENTS The information given shall enable the reci pient to identify readily the hazards of the components of the preparation. The hazards of the preparation itself shall be given under heading 2. 3.1. It is not necessary to give the full com position (nature of the ingredients and their concentration), although a genera l description of the component s and their concentrations can be helpful. 3.2. For a preparation classified as dangerous according to Directive 1999/45/EC, the following substances shall be indicated, together with their concentration or concentration range in the preparation: (a) substances presenting a health or environmental hazard within the meaning of Directive 67/548/EEC, if they are present in concentrations equal to or greater than the lowest of: – the applicable concentrations define d in the table of Article 3(3) of Directive 1999/45/EC, or – the concentration limits given in An nex I to Directive 67/548/EEC, or – the concentration limits given in Part B of Annex II to Directive 1999/45/EC, or

279. 30.12.2006 EN Official Journal of the European Union L 396/279 Where a Chemical Safety Report is requi red, the relevant DNELs and PNECs for the substance shall be given for the exposure scenarios set out in the annex to the Safety Data Sheet. For preparations, it is useful to provide values for those co nstituent substances which are required to be listed in the Safety Data Sheet according to heading 3. 8.2. Exposure controls For the purposes of this document exposure co ntrol means the full range of specific risk management measures to be taken during use in order to minimise worker and environmental exposure. Where a chemical safety report is required, a summary of the risk management measures shall be given in S ection 8 of the Safety Data Sheet for the identified uses set out in the Safety Data Sheet. 8.2.1. Occupational exposure controls This information will be taken into account by the employer in carryi ng out an assessment of risk to the health and safety of workers for the substance or pr eparation under Article 4 of Directive 98/24/EC, which requir es, in the order of priority: – design of appropriate work processes and e ngineering controls, the use of adequate equipment and materials, – the application of collectiv e protection measures at source, such as adequate ventilation and appropriate organisational measures, and – where exposure cannot be prevented by othe r means the use of individual protection measures, such as personal protection equipment.

397. 30.12.2006 EN Official Journal of the European Union L 396/397 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 6. Without prejudice to the implementation of other Community provisions relating to the labelling of dangerous substances and preparations, equipment and installations containing PCTs must also display instructions concerning the disposal of PCTs and the maintenance and use of equipment and installations containing them. These instructions must be capable of being read horizontally when the object containing the PCTs is installed in the normal way. The inscription must sta nd out clearly from its background and shall be in a language which is understood in the territory where it is being used. 2. Chloro-1-ethylene (monomer vinyl chloride) CAS No 75-01-4 EINECS No 200-831-0 Shall not be used as aerosol propellant for any use. 3. Liquid substances or preparations, which are regarded as dangerous according to the definitions in Council Directive 67/548/EEC and Directive 1999/45/EC. 1. Shall not be used in: – ornamental objects, intended to produce light or colour effects by means of different phases, for example in ornamental lamps and ashtrays, – tricks and jokes, – games for one or more participants, or any object intended to be used as such, even with ornamental aspects.

398. L 396/398 EN Official Journal of the European Union 30.12.2006 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 2. Without prejudice to paragraph 1, substances and preparations which: – present an aspiration hazard and are labelled with R65, and – can be used as fuel in decorative lamps, and – are placed on the market in packaging of a capacity of 15 litres or less, shall not contain a colouring agent, unless required for fiscal reasons, or perfume or both. 3. Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of dangerous substances and preparations, the packaging of substances and preparations covered by paragraph 2, where intended for use in lamps, must be marked legibly and indelibly as follows: "Keep lamps filled with this liquid out of the reach of children". 4. Tris (2,3 dibromopropyl) phosphate CAS No 126-72-7 Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin.

406. L 396/406 EN Official Journal of the European Union 30.12.2006 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 18. Mercury compounds 1. Shall not be used as substances and constituents of prepara tions intended for use: (a) to prevent the fouling by micro-organisms, plants or animals of: – the hulls of boats, – cages, floats, nets and any other appliances or equipment used for fish or shellfish farming, – any totally or partly submerged appliances or equipment; (b) in the preservation of wood; (c) in the impregnation of heavy-duty industrial textiles and yarn intended for their manufacture; (d) in the treatment of industrial waters, irrespective of their use.

407. 30.12.2006 EN Official Journal of the European Union L 396/407 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 2. The placing on the market of batteries and accumulators, containing more than 0,0005 % of mercury by weight, including in those cases where these batteries and accumulators are incorporated into appliances shall be prohibited. Button cells and batteries composed of button cells with a mercury content of no more than 2 % by weight shall be exempted from this prohibition. 19. Arsenic compounds 1. Shall not be used as substances and constituents of prepara tions intended for use: (a) to prevent the fouling by micro-organisms, plants or animals of: – the hulls of boats, – cages, floats, nets and any other appliances or equipment used for fish or shellfish farming, – any totally or partly submerged appliances or equipment; (b) in the preservation of wood. Furthermore, wood so treated shall not be placed on the market;

408. L 396/408 EN Official Journal of the European Union 30.12.2006 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction (c) however, by way of derogation: (i) Relating to the substances and preparations in the preservation of wood: these may only be used in industrial installations using vacuum or pressure to impregnate wood if they are solutions of inorganic compounds of the copper, chromium, arsenic (CCA) type C. Wood so treated shall not be placed on the market before fixation of the preservative is completed. (ii) Relating to wood treated with CCA solutions in industrial installations according to point (i): this may be placed on the market for professional and industrial use provided that the structural integrity of the wood is required for human or livestock safety and skin contact by the general public during its service life is unlikely: – as structural timber in public and agricultural buildings, office buildings, and industrial premises, – in bridges and bridgework, – as constructional timber in freshwater areas and brackish waters e.g. jetties and bridges,

424. L 396/424 EN Official Journal of the European Union 30.12.2006 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction Carcinogen category 2 listed in Appendix 2. 29. Substances which appear in Annex I to Directive 67/548/EEC classified as mutagen category 1 or mutagen category 2 and labelled with risk phrase R46: "May cause heritable genetic damage", and listed as follows: Mutagen category 1 listed in Appendix 3. Mutagen category 2 listed in Appendix 4. – the relevant concentration specified in Directive 1999/45/EC. Without prejudice to the implementation of other Community provis ions relating to the classification, packaging and labelling of dangerous substances and preparations, the packaging of such substances and preparations must be marked legibly and indelibly as follows: "Restricted to professional users". 30. Substances which appear in Annex I to Directive 67/548/EEC classified as toxic to reproduction category 1 or toxic to reproduction category 2 and labelled with risk phrase R60: "May impair fertility" and/or R61: "May cause harm to the unborn child", and listed as follows: Toxic to reproduction category 1 listed in Appendix 5. Toxic to reproduction category 2 listed in Appendix 6. 2. By way of derogation, paragraph 1 shall not apply to: (a) medicinal or veterinary products as defined by Directive 2001/82/EC and Directive 2001/83/EC; (b) cosmetic products as defined by Council Directive 76/768/EEC; (c) – motor fuels which are covered by Directive 98/70/EC, – mineral oil products intended for use as fuel in mobile or fixed combustion plants, – fuels sold in closed systems (e.g. liquid gas bottles); (d) artists' paints covered by Directive 1999/45/EC.

426. L 396/426 EN Official Journal of the European Union 30.12.2006 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction (d) creosote oil, acenaphthene fraction; wash oil CAS No 90640-84-9 EINECS No 292-605-3 (e) distillates (coal tar), upper; heavy anthracene oil CAS No 65996-91-0 EINECS No 266-026-1 – may be placed on the market only in packaging of a capacity equal to or greater than 20 litres, – shall not be sold to consumers. Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the packaging of such substances and preparations shall be legibly and indelibly marked as follows: (f) anthracene oil CAS No 90640-80-5 EINECS No 292-602-7 (g) tar acids, coal, crude; crude phenols CAS No 65996-85-2 EINECS No 266-019-3 (h) creosote, wood CAS No 8021-39-4 EINECS No 232-419-1 "For use in industrial installations or professional treatment only". (b) Relating to wood treated in industrial installations or by professionals according to point (a) which is placed on the market for the first time or retreated in-situ : this is permitted for professional and industrial use only, e.g. on railways, in electric power transmission and telecommunications, for fencing, for agricultural purposes (e.g. stakes for tree support) and in harbours and waterways. (c) The prohibition in paragraph 1 on the placing on the market shall not apply to wood which has been treated with substances listed in entry 31(a) to (i) before 31 December 2002 and is placed on the second-hand market for re-use.

430. L 396/430 EN Official Journal of the European Union 30.12.2006 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction 40. Substances meeting the criteria of flammability in Directive 67/548/EEC and classified as flammable, highly flammable or extremely flammable regardless of whether they appear in Annex I to that Directive or not. 1. Shall not be used on their own or in the form of preparations in aerosol generators that are placed on the market for the general public for entertainment and decorative purposes such as the following: – metallic glitter intended mainly for decoration, – artificial snow and frost, – "whoopee" cushions,

319. 30.12.2006 EN Official Journal of the European Union L 396/319 COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 7.5. Vapour pressure 7.5. The study does not need to be c onducted if the melting point is above 300 ° C. If the melting point is between 200 ° C and 300 ° C, a limit value based on measurement or a recognised calculation method is sufficient. 7.6. Surface tension 7.6. The st udy need only be conducted if: – based on structure, surface activity is expected or can be predicted; or – surface activity is a desired property of the material. If the water solubility is below 1 mg/l at 20°C the test does not need to be conducted. 7.7. Water solubility 7.7. The stud y does not need to be conducted if: – the substance is hydrolytically unstable at pH 4, 7 and 9 (half-life less than 12 hours); or – the substance is readily oxidisable in water. If the substance appears "insoluble" in water, a lim it test up to the detection limit of the analytical method shall be performed. 7.8. Partition coefficient n-octanol/water 7.8. The study does not need to be conducted if the s ubstance is inorganic. If the t est cannot be

458. L 396/458 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Distillates (petroleum), chemically neutralised light naphthenic; Unrefined or mildly refined base oil (A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C 15 through C 30 , and produces a finished oil with a viscosity of less than 19 10 -6 m 2 .s -1 at 40°C. It contains relatively few normal paraffins.) 649-061-00-0 265-136-7 64742-35-4 Gases (petroleum), catalytic cracked naphtha depropaniser overhead, C 3 -rich acid-free; Petroleum gas (A complex combination of hydrocarbons obtained from fractionation of catalytic cracked hydrocarbons and treated to remove acidic impurities. It consists of hydrocarbons having carbon numbers in the range of C 2 through C 4 , predominantly C 3 .) 649-062-00-6 270-755-0 68477-73-6 H, K Gases (petroleum), catalytic cracker; Petroleum gas (A complex combination of hydrocarbons produced by the distillation of the products from a catalytic cracking process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 .) 649-063-00-1 270-756-6 68477-74-7 H, K

138. L 396/138 EN Official Journal of the European Union 30.12.2006 Article 54 Publication of information on evaluation By 28 February of each year, the Agency shall p ublish on its website a report on the progress made over the previous calendar year towards discharg ing the obligations incumb ent upon it in relation to evaluation. This report shall include, in particular, recommendations to potential registrants in order to improve the quality of future registrations. TITLE VII AUTHORISATION Chapter 1 Authorisation requirement Article 55 Aim of authorisation and considerations for substitution The aim of this Title is to ensu re the good functioning of the internal market while assuring that the risks from substances of very high concern are pr operly controlled and that these substances are progressively replaced by suitable alternativ e substances or technol ogies where these are economically and technically viable. To this end all manufacturers, importers and downstream users applying for authorisations shall analyse the availabil ity of alternatives and c onsider their risks, and the technical and economic feasibility of substitution.

413. 30.12.2006 EN Official Journal of the European Union L 396/413 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction (b) in the impregnation of fibres and heavy-duty textiles not intended in any case for clothing or for decorative furnishings; (c) by way of special exception, Member States may on a case-by-case basis, permit on their territory specialised professionals to carry out in situ and for buildings of cultural, artistic and historical interest, or in emergencies, a remedial treatment of timber and masonry infected by dry rot fungus (Serpula lacrymans) and cubic rot fungi. In any case: (a) Pentachlorophenol used alone or as a component of preparations employed within the framework of the above exceptions must have a total hexachlorodibenzoparadioxin (HCDD) content of not more than two parts per million (ppm); (b) these substances and preparations shall not: – be placed on the market except in packages of 20 litres or more; – be sold to the general public.

5. 30.12.2006 EN Official Journal of the European Union L 396/5 (10) Substances under customs supervision which ar e in temporary storage, in free zones or free warehouses with a view to re-exportation or in transit are not used w ithin the meaning of this Regulation and should therefore be exclude d from its scope. The carriage of dangerous substances and of dangerous preparations by ra il, road, inland waterway s, sea or air should also be excluded from its scope as specific le gislation already applie s to such carriage. (11) To ensure workability and to maintain th e incentives for waste recycling and recovery, wastes should not be regarded as substances, pr eparations or articles within the meaning of this Regulation. (12) An important objective of the new system to be established by this Regulation is to encourage and in certain cases to ensure that substances of high concern are eventually replaced by less dangerous substances or t echnologies where suitable economically and technically viable alternatives are available. This Regulation does not affect the application of Directives on worker protection and the e nvironment, especially Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within th e meaning of Article 16(1) of Council Directive 89/391/EEC) 1 and Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Dir ective within the meani ng of Article 16(1) of Directive 89/391/EEC) 2 under which employers are requ ired to eliminate dangerous substances, wherever technically possible, or to substitute dangerous substances with less dangerous substances. 1 OJ L 158, 30.4.2004, p. 50. Corrected in OJ L 229, 29.6.2004, p. 23. 2 OJ L 131, 5.5.1998, p. 11.

14. L 396/14 EN Official Journal of the European Union 30.12.2006 (37) If tests are performed, they should comply w ith the relevant requireme nts of protection of laboratory animals, set out in Council Di rective 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and admini strative provisions of the Member States regarding the protection of animals used fo r experimental and other scientific purposes 1 , and, in the case of ecotoxicological and t oxicological tests, g ood laboratory practice, set out in Directive 2004/10/ EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the applicat ion of the principles of good labor atory practice and the verification of their application for tests on chemical substances 2 . (38) The generation of informati on by alternative means offering e quivalence to prescribed tests and test methods should also be allowed, for example when this information comes from valid qualitative or quantitative structure activ ity models or from structurally related substances. To this end the Agency, in coope ration with Member St ates and interested parties, should develop appr opriate guidance. It should also be possible not to submit certain information if appropriate justif ication can be provided. Based on experience gained through RIPs, criteria should be developed defining what constitutes such justification. (39) In order to help companies, and in partic ular SMEs, to comply w ith the requirements of this Regulation, Member States, in add ition to the operational guidance documents provided by the Agency, should es tablish national helpdesks. 1 OJ L 358, 18.12.1986, p. 1. Directive as amended by Directive 2003/65/EC of the European Parliament and of the Council (OJ L 230, 16.9.2003, p. 32). 2 OJ L 50, 20.2.2004, p. 44.

36. L 396/36 EN Official Journal of the European Union 30.12.2006 (117) EU-citizens should have access to informa tion about chemicals to which they may be exposed, in order to allow them to make info rmed decisions about their use of chemicals. A transparent means of achieving this is to grant them free and easy access to basic data held in the Agency's database, including br ief profiles of hazardous properties, labelling requirements and relevant Comm unity legislation including authorised uses and risk management measures. The Agency and Me mber States should allow access to information in accordance with Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information 1 , Regulation (EC) No 1049/2001 of the Europ ean Parliament and of the Council of 30 May 2001 regarding public access to Eur opean Parliament, Council and Commission documents 2 and with the UNECE Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters, to which the European Community is a party. (118) Disclosure of information under this Regula tion is subject to the specific requirements of Regulation (EC) No 1049/2001. That Regulation sets binding de adlines for the release of information as well as procedural guaran tees, including the right of appeal. The Management Board should adopt the practic al arrangements for application of those requirements to the Agency. 1 OJ L 41, 14.2.2003, p. 26. 2 OJ L 145, 31.5.2001, p. 43.

155. 30.12.2006 EN Official Journal of the European Union L 396/155 4. If an environmental quality standard referre d to in Directive 96/61/EC is not met, the authorisations granted for the use of th e substance concerned may be reviewed. 5. If the environmental objectives as referred to in Article 4(1) of Directive 2000/60/EC are not met, the authorisations granted for the us e of the substance concerned in the relevant river basin may be reviewed. 6. If a use of a substance is subsequently prohibited or otherw ise restricted in Regulation (EC) No 850/2004 of the Europ ean Parliament and of the Council of 29 April 2004 on persistent organic pollutants 1 , the Commission shall withdraw the authorisation for that use. Article 62 Applications for authorisations 1. An application for an authorisation shall be made to the Agency. 2. Applications for authorisation may be made by the manufacturer(s), importer(s) and/or downstream user(s) of the substa nce. Applications may be ma de by one or several persons. 3. Applications may be made for one or severa l substances, that meet the definition of a group of substances in section 1.5 of Annex XI , and for one or several uses. Applications may be made for the applicant' s own use(s) and/or for uses for which he intends to place the substance on the market. 1 OJ L 158, 30.4.2004, p. 7. Corrected in OJ L 229, 29.6.2004, p. 5.

292. L 396/292 EN Official Journal of the European Union 30.12.2006 15. REGULATORY INFORMATION Indicate if a Chemical Safety Assessment has been carried out for the substance (or a substance in the preparation). Give the health, safety and environmenta l information shown on the label according to Directives 67/548/EEC and 1999/45/EC. If the substance or preparation covered by this safety data sheet is the subject of specific provisions in relation to pr otection of man or the envi ronment at Community level (e.g. authorisations given under Title VII or re strictions under Title VIII) these provisions shall, as far as is possible, be stated. Also mention, where possible, the national la ws which implement these provisions and any other national measures that may be relevant. 16. OTHER INFORMATION Indicate any other information which the suppl ier assesses as being of importance for the health and safety of the user and for the protection of the environment, for example: – list of relevant R phrases. Write out the fu ll text of any R phrases referred to under headings 2 and 3 of the Safety Data Sheet, – training advice, – recommended restrictions on use (i.e. non- statutory recommendations by supplier),

316. L 396/316 EN Official Journal of the European Union 30.12.2006 ANNEX VII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 TONNE OR MORE 1 Column 1 of this Annex establishes th e standard information required for: (a) non-phase-in substances manufactured or im ported in quantities of 1 to 10 tonnes; (b) phase-in substances manufactured or imported in quantities of 1 to 10 tonnes and meeting the criteria in Annex III in accordance with Article 12(1)(a) and (b); and (c) substances manufactured or importe d in quantities of 10 tonnes or more. Any other relevant physicochemi cal, toxicological and ecotoxicological information that is available shall be provided. For substances no t meeting the criteria in Annex III only the physicochemical requirements as set out in section 7 of this Annex are required. Column 2 of this Annex lists specific rules acco rding to which the required standard information may be omitted, replaced by other information, provide d at a different stage or adapted in another way. If the conditions are met under which column 2 of this Annex allows adaptations, the registrant shall clearly state this fact and th e reasons for each adapta tion under the appropriate headings in the registration dossier. 1 This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users th at are required to carry out tests under this Regulation adapted as necessary.

387. 30.12.2006 EN Official Journal of the European Union L 396/387 ANNEX XV DOSSIERS I. INTRODUCTION AND GENERAL PROVISIONS This Annex lays down general principles for preparing dossiers to propose and justify: – harmonised classification and labelling of CMRs, respiratory sensitisers and other effects, – the identification of PBTs, V P V Bs, or a substance of equivalent concern, – restrictions of the manufact ure, placing on the market or use of a substance within the Community. The relevant parts of Annex I shall be used for the methodology and format of any dossier according to this Annex. For all dossiers any relevant information from registration dossiers shall be considered and other available information may be used. For hazard information which has not been previously submitted to the Agency, a robust study summary shall be included in the dossier.

390. L 396/390 EN Official Journal of the European Union 30.12.2006 3. Dossiers for restrictions proposal Proposal The proposal shall include the identity of th e substance and the rest riction(s) proposed for the manufacture, placing on the market or us e(s) and a summary of the justification. Information on hazard and risk The risks to be addressed with the restriction sha ll be described based on an assessment of the hazard and risks according to the relevant parts of Annex I and shall be documented in the format set out in Part B of that Annex for the Chemical Safety Report. Evidence shall be provided that implemented risk management measures (including those identified in registrations under Arti cles 10 to 14) are not sufficient. Information on alternatives Available information on alternative subs tances and techniques shall be provided, including: – information on the risks to human health and the environment related to the manufacture or use of the alternatives, – availability, including the time scale, – technical and economical feasibility.

775. 30.12.2006 EN Official Journal of the European Union L 396/775 Substances Index number EC number CAS number Notes Hydrocarbons, C 1-4 , sweetened; Petroleum gas (A complex combination of hydrocarbons obtained by subjecting hydrocarbon gases to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 and boiling in the range of approximately − 164 °C to − 0,5 °C.) 649-089-00-3 271-038-5 68514-36-3 H, K Hydrocarbons, C 1-3 ; Petroleum gas (A complex combination of hydrocarbons having carbon numbers predominantly in the range of C 1 through C 3 and boiling in the range of approximately − 164 °C to − 42 °C.) 649-090-00-9 271-259-7 68527-16-2 H, K

244. L 396/244 EN Official Journal of the European Union 30.12.2006 1.0.6. Step 4 of the human health hazard assessmen t shall be undertaken by integrating the results from the first three steps and shall be included under the rele vant heading of the Chemical Safety Report and summarised in the Safety Data Sheet under heading 8.1. 1.1. Step 1: Evaluation of non-human information 1.1.1. The evaluation of non-human information shall comprise: – the hazard identification for the effect ba sed on all available non-human information; – the establishment of the quantitative dose (concentration) – response (effect) relationship. 1.1.2. When it is not possible to establish the quant itative dose (concentration) – response (effect) relationship, then this should be justified a nd a semi-quantitative or qualitative analysis shall be included. For instance, for acute effect s it is usually not possible to establish the quantitative dose (concentration) – response (effect) relationshi p on the basis of the results of a test conducted in accordance with test methods laid down in a Commission Regulation as specified in Article 13(3). In such cases it suffices to determine whether and to which degree the substance has an inherent capacity to cause the effect. 1.1.3. All non-human information used to assess a pa rticular effect on humans and to establish the dose (concentration) – response (effect) re lationship, shall be briefly presented, if possible in the form of a table or tables, distinguishing between in vitro , in vivo and other information. The relevant test results (e.g. LD50, NO(A)EL or LO(A)EL) and test conditions (e.g. test duration, rout e of administration) and othe r relevant information shall be presented, in internationally recognis ed units of measurement for that effect.

377. 30.12.2006 EN Official Journal of the European Union L 396/377 The similarities may be based on: 1) a common functional group; 2) the common precursors and/or the likelihood of common breakdown products via physical and biological processes, which resu lt in structurally similar chemicals; or 3) a constant pattern in the changing of the potency of the properties across the category. If the group concept is applied, substances shall be classified and labelled on this basis. In all cases results should: – be adequate for the purpose of classifica tion and labelling and/or risk assessment, – have adequate and reliable coverage of the key parameters addressed in the corresponding test method refe rred to in Article 13(3), – cover an exposure duration comparable to or longer than the corresponding test method referred to in Article 13(3) if expos ure duration is a relevant parameter, and – adequate and reliable documentation of the applied method shall be provided.

802. L 396/802 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gases (petroleum), benzene unit hydrotreater depentaniser overheads; Refinery gas (A complex combination produced by treating the feed from the benzene unit with hydrogen in the presence of a catalyst followed by depentanising. It consists primarily of hydrogen, ethane and propane with various small amounts of nitrogen, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 6 . It may contain trace amounts of benzene.) 649-149-00-9 271-623-5 68602-82-4 H, K

806. L 396/806 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gases (petroleum), hydrotreated sour kerosine flash drum; Refinery gas (A complex combination obtained from the flash drum of the unit treating sour kerosine with hydrogen in the presence of a catalyst. It consists primarily of hydrogen and methane with various small amounts of nitrogen, carbon monoxide, and hydro-carbons having carbon numbers predominantly in the range of C 2 through C 5 .) 649-156-00-7 272-776-0 68911-59-1 H, K

812. L 396/812 EN Official Journal of the European Union 30.12.2006 Substances Index number EC number CAS number Notes Gases (petroleum), sponge absorber off, fluidised catalytic cracker and gas oil desulphuriser overhead fractionation; Refinery gas (A complex combination obtained by the fractionation of products from the fluidised catalytic cracker and gas oil desulphuriser. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C 1 through C 4 .) 649-167-00-7 273-269-7 68955-33-9 H, K

101. 30.12.2006 EN Official Journal of the European Union L 396/101 Chapter 3 Rules for phase-in-substances Article 28 Duty to pre-register for phase-in substances 1. In order to benefit from the transitional regime provided for in Article 23 each potential registrant of a phase-in substa nce in quantities of 1 tonne or more per year, including without limitation intermediates, shall submit all the following information to the Agency: (a) the name of the substance as specifie d in section 2 of A nnex VI, including its EINECS and CAS number or, if not av ailable, any other identity codes; (b) his name and address and the name of the contact person and, where appropriate, the name and address of the person representi ng him in accordance with Article 4 as specified in section 1 of Annex VI; (c) the envisaged deadline for the registration and the tonnage band; (d) the name(s) of substance(s) as specified in section 2 of Anne x VI, including their EINECS and CAS number or, if not availabl e, any other identity codes, for which the available information is relevant for th e application of sections 1.3 and 1.5 of Annex XI.

417. 30.12.2006 EN Official Journal of the European Union L 396/417 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction In any case, whatever their use or intended final purpose, the placing on the market of the above finished articles or components of articles manufactured from polymers or copolymers of vinyl chloride, stabilised by substances containing cadmium shall be prohibited, if their cadmium content (expressed as Cd metal) exceeds 0,01 % by mass of the polymer. 4. However, paragraph 3 does not apply to finished articles using cadmium-based stabilisers for safety reasons. 5. Within the meaning of this Regulation, "cadmium plating" means any deposit or coating of metallic cadmium on a metallic surface. Shall not be used for cadmium plating metallic articles or components of the articles used in the sectors/applications listed below: (a) equipment and machinery for: – food production [8210] [8417 20] [8419 81] [8421 11] [8421 22] [8422] [8435] [8437] [8438] [8476 11] – agriculture [8419 31] [8424 81] [8432] [8433] [8434] [8436] – cooling and freezing [8418] – printing and book-binding [8440] [8442] [8443] 3

48. L 396/48 EN Official Journal of the European Union 30.12.2006 Article 2 Application 1. This Regulation shall not apply to: (a) radioactive substances within the sc ope of Council Direct ive 96/29/Euratom of 13 May 1996 laying down basic safety standard s for the protection of the health of workers and the general public against the dangers arising from ionising radiation 1 ; (b) substances, on their own, in a preparation or in an article, which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary st orage, or in a free zone or free warehouse with a view to re-exportation, or in transit; (c) non-isolated intermediates; (d) the carriage of dangerous substances and dangerous substances in dangerous preparations by rail, road, inland waterway, sea or air. 2. Waste as defined in Directive 2006/12/EC of the European Parliament and of the Council 2 is not a substance, preparation or article with in the meaning of Article 3 of this Regulation. 3. Member States may allow for exemptions from this Regulation in specific cases for certain substances, on their own, in a preparation or in an article, where necessary in the interests of defence. 1 OJ L 159, 29.6.1996, p. 1. 2 OJ L 114, 27.4.2006, p. 9.

205. 30.12.2006 EN Official Journal of the European Union L 396/205 Article 104 Languages 1. Regulation No 1 of 15 April 1958 determining the languages to be used in the European Economic Community 1 shall apply to the Agency. 2. The translation services required for the func tioning of the Agency shall be provided by the Translation Centre of the bodi es of the European Union. Article 105 Duty of confidentiality Members of the Management Board, members of the Committees and of the Forum, experts and officials and other servants of the Agency, shall be required, even after thei r duties have ceased, not to disclose information of the kind c overed by the duty of professional secrecy. Article 106 Participation of third countries The Management Board may, in agreement with the relevant Committee or the Forum, invite representatives of third c ountries to participate in the work of the Agency. 1 OJ 17, 6.10.1958, p. 385. Regulation as last amended by Council Regulation (EC) No 920/2005 (OJ L 156, 18.6.2005, p. 3).

226. L 396/226 EN Official Journal of the European Union 30.12.2006 Article 134 Preparation of establishment of the Agency 1. The Commission shall afford the necessa ry support towards the establishment of the Agency. 2. For that purpose, until such time as the Ex ecutive Director takes up his duties following his appointment by the Management Board of the Agency in accordance with Article 84, the Commission, on behalf of the Agency, and using the budget provided for the latter, may (a) appoint personnel, including a person who shall fulfil the admini strative functions of the Executive Director on an interim basis; and (b) conclude other contracts. Article 135 Transitional measures regar ding notified substances 1. The requests to notifiers to provide furthe r information to the competent authority in accordance with Article 16(2) of Directive 67/548/EEC, shall be considered as decisions adopted in accordance with Article 51 of this Regulation.

401. 30.12.2006 EN Official Journal of the European Union L 396/401 Designation of the substance, of the groups of substances or of the preparation Conditions of restriction Member States shall not permit the introduction of new applications for chrysotile asbestos on their territories. 3. Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the placing on the market and use of these fibres and of articles containing these fibres, as permitted according to the preceding derogations, shall be permitted only if the articles bear a label in accordance with the provisions of Appendix 7 to this Annex. 7. Tris(aziridinyl)phosphinoxide CAS No 5455-55-1 8. Polybromobiphenyls; Polybrominatedbiphenyls (PBB) CAS No 59536-65-1 Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin. 9. Soap bark powder (Quillaja saponaria) and its derivatives containing saponines Powder of the roots of Helleborus viridis and Helleborus niger Powder of the roots of Veratrum album and Veratrum nigrum 1. Shall not be used in jokes and hoaxes or in objects intended to be used as such, for instance as a constituent of sneezing powder and stink bombs. 2. However, paragraph 1 does not apply to stink bombs containing not more than 1,5 ml of liquid.

81. 30.12.2006 EN Official Journal of the European Union L 396/81 2. Active substances manufactured or imported fo r use in biocidal products only and included either in Annexes I, IA or IB to Directive 98/8/EC of the Eu ropean Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market 1 or in Commission Regulation (EC) No 2