2.

The Commission, in consultation with the Member States, shall determine the cases in which it is necessary to request the manufacturers and importers of the substances declared in pursuance of paragraph 1 to submit additional information, in the framework of Annex III, on the physico-chemical properties, toxicity, and ecotoxicity of such substances, exposure and any other aspect relevant to the risk evaluation of the substances. However, without prejudice to Article 12 (2), manufacturers and importers are not bound to carry out further tests on animals for that purpose. The specific information to be submitted and the procedure to be followed for this submission shall be determined in accordance with the procedure laid down in Article 15.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.