第86条 物質の制限手続

1. If the Commission considers that the use of a substance in the manufacture of batteries, or the presence of a substance in the batteries when they are placed on the market, or during their subsequent life cycle stages, including during repurposing or treatment of waste batteries, poses a risk to human health or the environment that is not adequately controlled and needs to be addressed on a Union-wide basis, it shall request the Agency to prepare a restriction dossier which conforms to the requirements of Annex XV to Regulation (EC) No 1907/2006. The restriction dossier shall include a socioeconomic assessment, including an analysis of alternatives.

2. Within 12 months of the receipt of the request from the Commission referred to in paragraph 1 of this Article and if the restriction dossier prepared by the Agency pursuant to that paragraph demonstrates that action is necessary on a Union-wide basis, in addition to any measures already in place, the Agency shall suggest restrictions in order to initiate the process described in paragraphs 4 to 9 of this Article and Articles 87 and 88.

3. If a Member State considers that the use of a substance in the manufacture of batteries, or the presence of a substance in the batteries when they are placed on the market, or during their subsequent life cycle stages, including during repurposing or treatment of waste batteries, poses a risk to human health or the environment that is not adequately controlled and needs to be addressed on a Union-wide basis, it shall notify the Agency that it proposes to prepare a restriction dossier. The Member State shall prepare a restriction dossier. The restriction dossier shall include a socioeconomic assessment, including an analysis of alternatives.

If the restriction dossier demonstrates that action on a Union-wide basis is necessary, in addition to any measures already in place, the Member State shall submit it to the Agency in the format set out in Annex XV to Regulation (EC) No 1907/2006, in order to initiate the process described in paragraphs 4 to 9 of this Article, and Articles 87 and 88.

4. For the purposes of the restriction dossier and the restriction process, the Agency or Member States shall take into account any dossier, chemical safety report or risk assessment submitted to the Agency or a Member State under the Regulation (EC) No 1907/2006. The Agency or Member States shall also take into account any available information and refer to any relevant risk assessment submitted for the purposes of other Union law covering the life cycle of the substance used in the battery, including the waste phase. To this end, other bodies established under Union law and carrying out a similar task shall provide information to the Agency or Member State concerned on request.

5. Access to information held by the Agency in performing the tasks defined in Article 6 of this Regulation and in this Article shall be subject to Article 118 of Regulation (EC) No 1907/2006.

6. The Agency shall maintain a list of substances for which a restriction dossier under this Article is planned by or in progress in either the Agency or a Member State.

7. The Committee for Risk Assessment, set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006, and the Committee for Socioeconomic Analysis, set up pursuant to Article 76(1)(d) of that Regulation, shall check whether the restriction dossier submitted conforms to the requirements of Annex XV to that Regulation. Within 30 days of receipt of the dossier, 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 respective Committee, otherwise the procedure under this Article shall be terminated.

8. The Agency shall publish without delay the intention of the Commission or a Member State to initiate the restriction process for a substance, under this Article, and shall inform stakeholders concerned.

9. The Agency shall make publicly available on its website the restriction dossier, including the restrictions suggested pursuant to paragraphs 2 and 3 without delay, clearly indicating its date of publication. The Agency shall invite all stakeholders concerned to submit individually or jointly, within four months of the date of publication:

(a)comments on the restriction dossier and the suggested restrictions;

(b)a socioeconomic analysis of the suggested restrictions, including an analysis of alternatives, or information which can contribute to such an analysis, examining the advantages and drawbacks of the suggested restrictions. Such analysis shall conform to the requirements of Annex XVI to Regulation (EC) No 1907/2006.

10. The delegated acts referred to in Article 6(2) shall be adopted within nine months following the receipt of the opinion of the Committee for Socioeconomic Analysis of the Agency referred to in Article 87(2). If the Committee for Socioeconomic Analysis does not adopt an opinion by the deadline set in Article 87(2) or (5), as applicable, the Commission shall take into account the socioeconomic impact of the restriction, including the availability of alternatives for the substance and shall adopt a delegated act by the deadline set in Article 87(2).

11. Where the draft amendment to Annex I diverges from the original proposal of the restriction dossier, prepared pursuant to the procedure laid down in this Article and Articles 87 and 88, or if it does not take the opinions from the Agency into account, the Commission shall attach a detailed explanation of the reasons for the differences.