lexiara

1.

If he considers that there is a confidentiality problem, the manufacturer or importer may indicate the information provided for in Articles 3, 4, 7 and 12, which he considers to be commercially sensitive and disclosure of which might harm him industrially or commercially, and which he therefore wishes to be kept secret from all persons other than Member States and the Commission. Full justification must be given in such cases. Industrial and commercial secrecy shall not apply to: the name of the substance, as given in Einecs, the name of the manufacturer or importer, data on physico-chemical properties of the substance and on pathways and environmental fate, the summary results of the toxicological and ecotoxicological tests, in particular data on carcinogenity, mutagenicity and/or the substance's toxicity for reproduction, any information relating to the methods and precautions relating to the substance and the emergency measures, any information which, if withheld, might lead to animal experiments being carried out or repeated needlessly, analytical methods that make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans to the substance. If the manufacturer or importer should himself later disclose previously confidential information, he shall inform the competent authority accordingly.

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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.