Article 4

Data reporting on lower volume production or import of existing substances 1. Without prejudice to Article 6 (1), any manufacturer who has produced, or any importer who has imported, an existing substance, as such or in a preparation, in quantities exceeding 10 tonnes per year but no greater than 1 000 tonnes per year, at least once in the three years preceding the adoption of this Regulation and/or the year following its adoption, shall submit to the Commission, in accordance with the procedure laid down in Article 6 (2) and (3), the following information, as specified in Annex IV, within a period of 24 months, to start once the Regulation has been in force for three years: the name of the substance and the Einecs number; the quantity of the substance produced or imported; the classification of the substance according to Annex I to Directive 67/548/EEC or the provisional classification according to the said Directive, including the class of danger, the danger symbol, the risk phrases and the safety phrases; information on the reasonably foreseeable uses of the substance. 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.