anx_II__cpt_1__cpt_3__cpt_7__cpt_2

3.7.2. An active substance, safener or synergist shall only be approved if it is not considered to be a persistent, bioaccumulative and toxic (PBT) substance. A substance that fulfils all three of the criteria of the points below is a PBT substance. An active substance, safener or synergist fulfils the persistence criterion where: the half-life in marine water is higher than 60 days, the half-life in fresh or estuarine water is higher than 40 days, the half-life in marine sediment is higher than 180 days, the half-life in fresh or estuarine water sediment is higher than 120 days, or the half-life in soil is higher than 120 days. Assessment of persistency in the environment shall be based on available half-life data collected under appropriate conditions, which shall be described by the applicant. An active substance, safener or synergist fulfils the bioaccumulation criterion where the bioconcentration factor is higher than 2000. Assessment of bioaccumulation shall be based on measured data on bioconcentration in aquatic species. Data from both freshwater and marine water species can be used. An active substance, safener or synergist fulfils the toxicity criterion where: the long-term no-observed effect concentration for marine or freshwater organisms is less than 0,01 mg/l, the substance is classified as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) pursuant to Regulation (EC) No 1272/2008, or there is other evidence of chronic toxicity, as identified by the classifications STOT RE 1 or STOT RE 2 pursuant to Regulation (EC) No 1272/2008.

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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.