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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 (Text with EEA relevance)
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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 inclusion 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 prepare a dossier in accordance with relevant Sections of Annex XV for substances which in its opinion meet the criteria set out in Article 57. [F1The dossier may be limited, if appropriate, to a reference to an entry in Part 3 of Annex VI to Regulation (EC) No 1272/2008.] The Agency shall make this dossier available to the Member States.
3. Any Member State may prepare a dossier in accordance with Annex XV for substances which in its opinion meet the criteria set out in Article 57 and forward it to the Agency. [F1The dossier may be limited, if appropriate, to a reference to an entry in Part 3 of Annex VI to Regulation (EC) No 1272/2008.] 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 invite all interested parties to submit comments within a specified deadline to the Agency.
5. Within 60 days of circulation, the other Member States or the Agency may comment on the identification of the substance in relation to the criteria in Article 57 in the dossier to the Agency.
6. If the Agency does not receive or make any comments, it shall include this substance on the list referred to in paragraph 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.
8. If, within 30 days of the referral, the Member State Committee reaches a unanimous agreement on the identification, the Agency shall include the substance in the list referred to in paragraph 1. The Agency may include that substance in its recommendations under Article 58(3).
9. If the Member State Committee fails to reach a unanimous agreement, the Commission shall prepare a draft proposal on the identification of the substance within 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 inclusion of a substance has been taken.]
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).
Textual Amendments
F1Substituted by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance).
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