1.

As of 1 September 2013, any person wishing to place active substance(s) on the Union market on its own or in biocidal products (the ‘relevant person’) shall, for every active substance that they manufacture or import for use in biocidal products, submit to the Agency: a dossier complying with the requirements of Annex II or, where appropriate, with Annex IIA to Directive 98/8/EC; or a letter of access to a dossier as referred to under point (a); or a reference to a dossier as referred to under point (a) and for which all data protection periods have expired. If the relevant person is not a natural or legal person established within the Union, the importer of the biocidal product containing such active substance(s) shall submit the information required under the first subparagraph. For the purposes of this paragraph and for existing active substances listed in Annex II to Regulation (EC) No 1451/2007, Article 63(3) of this Regulation shall apply to all toxicological and ecotoxicological studies including any toxicological and ecotoxicological studies not involving tests on vertebrates. The relevant person to whom a letter of access to a dossier on the active substance has been issued shall be entitled to allow applicants for the authorisation of a biocidal product containing that active substance to make reference to that letter of access for the purposes of Article 20(1). By way of derogation from Article 60 of this Regulation, all data protection periods for substance/product-type combinations listed in Annex II to Regulation (EC) No 1451/2007, but not yet approved under this Regulation shall end on 31 December 2025.

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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.