4.

A biocidal product shall not be authorised for making available on the market for use by the general public where: it meets the criteria according to Directive 1999/45/EC for classification as: toxic or very toxic, a category 1 or 2 carcinogen, a category 1 or 2 mutagen, or toxic for reproduction category 1 or 2; it meets the criteria according to Regulation (EC) No 1272/2008 for classification as: acute oral toxicity category 1 or 2 or 3, acute dermal toxicity category 1 or 2 or 3, acute inhalation toxicity (gases and dust/mist) category 1 or 2 or 3, acute inhalation toxicity (vapours) category 1 or 2, a category 1A or 1B carcinogen, a category 1A or 1B mutagen, or toxic for reproduction category 1A or 1B; it meets the criteria for being PBT or vPvB in accordance with Annex XIII to Regulation (EC) No 1907/2006; it has endocrine-disrupting properties; or it has developmental neurotoxic or immunotoxic effects.

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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.