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3.

By way of derogation from Article 7 an application for the approval of a basic substance shall be submitted by a Member State or by any interested party to the Commission. The application shall be accompanied by the following information: any evaluations of its possible effects on human or animal health or the environment carried out in accordance with other Community legislation regulating the use of the substance; and other relevant information on its possible effects on human or animal health or the environment.

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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.