1. The Agency shall notify any draft decision under Articles 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 Agency 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 Agency (for decisions taken under Articles 40 and 41) shall take any comments received into account and may amend the draft decision accordingly.
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 registration, if appropriate, shall be put to zero and no further information may be requested with respect to that substance, unless the registrant notifies the restart of the manufacture or import of the substance or the production or import of the article, or the downstream user notifies the restart of the use. The Agency shall inform the competent authority 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, shall 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 Agency shall inform the competent 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;
(b) where the exposure to the substance manufactured or imported by the registrant(s), or to the substance in the article 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 .
1. The Agency shall notify its draft decision in accordance with 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 amendment, it may modify the draft decision. The Agency shall refer a draft decision, together with any amendments proposed, to the Member State Committee within 15 days of the end of the 30-day period referred to in paragraph 2.
5. The Agency shall forthwith communicate any proposal for amendment to any registrants or downstream users concerned and allow them to comment within 30 days. The Member State Committee shall take any comments received into account.
6. If, within 60 days of the referral, the Member State Committee reaches a unanimous agreement on the draft decision, the Agency 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 accordance 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.
1. The competent authority shall circulate its draft 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 .
1. Where registrants or downstream users are required to perform a test as a result of a decision taken under this Title, those registrants 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 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 to perform 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 concerned 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 able 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 provide security for that amount or fails to hand over a copy of the full study report of the study performed. All claims shall be enforceable in the national courts. Any person may choose to submit their claims for remuneration to an arbitration board and accept the arbitration order.
By 28 February of each year, the Agency shall publish on its website a report on the progress made over the previous calendar year towards discharging the obligations incumbent 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.]
Editorial Information
X1Substituted by Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Official Journal of the European Union L 396 of 30 December 2006).