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... 13. This Regulation should apply without prejudice to the prohibitions and 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⁽⁹⁾ in so far as substances are used and marketed as cosmetic ingredients and are within the scope of this Regulation. A phase-out of testing on vertebrate animals for the purpose of protecting human health as specified in Directive 76/768/EEC should take place with regard to the uses of those substances in cosmetics. ...

... 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 principle that industry should manufacture, import or use substances or place them on the market with such responsibility and care as may be required to ensure that, under reasonably foreseeable conditions, human health and the environment are not adversely affected. ...

... 18. Responsibility for the management of the risks of substances should lie 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 easily accessible, in particular for SMEs. ...

... 21. Although the information yielded on substances through evaluation should be used in the first place by manufacturers and importers to manage the risks related to their substances, it may also be used to initiate the authorisation or restrictions procedures under this Regulation or risk management procedures under other Community legislation. Therefore it should be ensured that this information is available to the competent authorities and may be used by them for the purpose of such procedures. ...

... 25. The responsibility to assess the risks and hazards of substances should be given, in the first place, to the natural or legal persons that manufacture or import substances, but only when they do so in quantities exceeding a certain 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 recommendations along the supply chain. This should include describing, documenting and notifying in an appropriate and transparent fashion the risks stemming from the production, use and disposal of each substance. ...

... 28. Scientific research and development normally 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. However, in order to encourage innovation, product and process oriented research and development should be exempted from the obligation to register for a certain 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 still requires further research and development performed by the potential registrant himself 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 the purposes of product and process oriented research and development, provided 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. ...

... 30. The requirements for undertaking chemical safety assessments by manufacturers and importers should be defined in detail in a technical annex to allow them to meet their obligations. To achieve fair burden sharing with their customers, manufacturers and importers should in their chemical safety assessment address not only 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. ...

... 121. In order to ensure compliance with this Regulation, Member States should put in place effective monitoring and control measures. The necessary inspections should be planned, carried out and their results should be reported. ...

... 3. This Regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. Its provisions are underpinned by the precautionary principle. ...

... 14) Distributor: means any natural 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; ...

... (a) non-isolated intermediate: means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which 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 reaction 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 manufacture 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; ...

... 8. The Agency shall forthwith communicate any draft decisions to the competent authorities of each Member State in which the manufacture, import, production or product and process orientated research takes place. When taking decisions as provided for in paragraphs 4 and 7, the Agency shall take into account any comments made by such competent authorities. ...

... 4. Paragraphs 2 and 3 shall apply 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 substance(s) from that intermediate takes place on other sites under the following strictly controlled conditions: ...

... The relevant Member State shall be the Member State within which the manufacture takes place or the importer is established. If the manufacturer has production sites in more than one Member State, the relevant Member State shall be the one in which the head office of the manufacturer is established. The other Member States where the production sites are established shall also be notified. The Agency shall forthwith notify the competent authority of the relevant Member State(s) when any further information submitted by the registrant is available on the Agency database. ...

... 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 sheet covering identified uses and including specific conditions resulting from the application of section 3 of Annex XI. Any downstream user shall include relevant exposure scenarios, and 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 exposure 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 according to Article 37(2). ...

... 2. In the event of a registrant, downstream user or distributor ceasing activity, 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 concerned shall be bound by the obligation in paragraph 1 in place of the registrant, downstream user or distributor. ...

... 1. A manufacturer, importer or downstream user shall not place a substance on the market for a use or use it himself if that substance is included in Annex XIV, unless: ...

... (ii) a date or dates at least 18 months 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 certain 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; ...

... 3. Applications may be made for one or several 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. ...

... Holders of an authorisation, as well as downstream users referred to in Article 56(2) including the substances in a preparation, shall include the authorisation number on the label before they place the substance or a preparation containing the substance 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 publicly available in accordance with Article 64(9). ...

... 3. Within 12 months of the receipt of the request from the Commission in paragraph 1 and if this dossier demonstrates that action on a Community-wide basis is necessary, beyond any measures already in place, the Agency shall suggest restrictions, in order to initiate the restrictions process. ...

... 4. If a Member State considers that the manufacture, 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 addressed 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 substance 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 within 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 Member State shall submit it to the Agency in the format outlined in Annex XV, in order to initiate the restrictions process. The Agency or Member States shall refer to any dossier, chemical safety 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 Directives. To this end other bodies, such as agencies, established under Community law and carrying out a similar task shall provide information to the Agency or Member State concerned on request. The Committee for Risk Assessment and the Committee for Socio-economic Analysis shall check whether the dossier submitted conforms 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 conforms. 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 this Chapter shall be terminated. The Agency shall publish without delay the intention of the Commission or of a Member State to instigate a restriction procedure for a substance and shall inform those who submitted a registration for that substance. ...

... 1. The Management Board shall elect a Chairman and a Deputy-Chairman from among the members with voting rights. The Deputy-Chairman shall automatically take the place of the Chairman if he is prevented from attending to his duties. ...

... 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 Executive Director shall decide whether to agree to such requests. When each appointment is published, the professional qualifications of each member shall be specified. ...

... 7. On the basis of the estimate, the Commission shall enter in the preliminary 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 accordance with Article 272 of the Treaty. ...

... 1. Any manufacturer, producer of articles or importer, or group of manufacturers or producers of articles or importers, who place on the market a substance within the scope of Article 112, shall notify to the Agency the following information in order for it to be included in the inventory in accordance with Article 114, unless submitted as part of the registration: ...

... Member States shall appoint the competent authority 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 implementation 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. ...