1. — Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22…

1.

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products Text with EEA relevance · European Union

An application for approval of an active substance shall contain at least the following elements: a dossier for the active substance satisfying the requirements set out in Annex II; a dossier satisfying the requirements set out in Annex III for at least one representative biocidal product that contains the active substance; and if the active substance meets at least one of the exclusion criteria listed in Article 5(1), evidence that Article 5(2) is applicable.

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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.