Article 3

Data reporting on high volume production or import of existing substances 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 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, must submit to the Commission, in accordance with the procedure laid down in Article 6 (2) and (3), the following information, as specified in Annex III, within 12 months of entry into force of this Regulation in the case of a substance appearing in Annex I and within 24 months in the case of a substance appearing in Einecs but not in Annex I: the name and the Einecs number of the substance; the quantity of the substance produced or imported; the classification of the substance according to Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous substances(7) 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; data on the physico-chemical properties of the substance; data on pathways and environmental fate; data on the ecotoxicity of the substance; data on the acute and subacute toxicity of the substance; data on carcinogenicity, mutagenicity and/or toxicity for reproduction of the substance; any other indication relevant to the risk evaluation of the substance. Manufacturers and importers must make all reasonable efforts to obtain existing data regarding points (e) to (j). However, in the absence of information, manufacturers and importers are not bound to carry out further tests on animals in order to submit such data.

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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.