2.

Active substances give rise to concern where: they meet the criteria for classification according to Regulation (EC) No 1272/2008 as: explosive/highly flammable, organic peroxide, acutely toxic of category 1, 2 or 3, corrosive of category 1A, 1B or 1C, respiratory sensitiser, skin sensitiser, germ cell mutagen of category 1 or 2; carcinogen of category 1 or 2, human reproductive toxicant of category 1 or 2 or with effects on or via lactation, specific target organ toxicant by single or repeated exposure, or toxic to aquatic life of acute category 1; they fulfil any of the substitution criteria set out in Article 10(1); or they have neurotoxic or immunotoxic properties. Active substances also give rise to concern, even if none of the specific criteria in points (a) to (c) are met, where a level of concern equivalent to that arising from points (a) to (c) can be reasonably demonstrated based on reliable information.

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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.