anx_II__cpt_1__cpt_3__cpt_7__cpt_1
3.7.1. An active substance, safener or synergist shall only be approved where it is not considered to be a persistent organic pollutant (POP). A substance that fulfils all three of the criteria of the points below is a POP. An active substance, safener or synergist fulfils the persistence criterion where there is evidence that the time it takes for a degradation of 50 % (DT50) in water is greater than 2 months, or that its DT50 in soil is greater than 6 months, or that its DT50 in sediment is greater than 6 months. An active substance, safener or synergist fulfils the bioaccumulation criterion where there is: evidence that its bio-concentration factor or bioaccumulation factor in aquatic species is greater than 5000 or, in the absence of such data, that the partition coefficient n-octanol/water (log Ko/w) is greater than 5, or evidence that the active substance, safener or synergist present other reasons for concern, such as high bioaccumulation in other non-target species, high toxicity or ecotoxicity. An active substance, safener or synergist fulfils the potential for long-range environmental transport criterion where: measured levels of the active substance, safener or synergist in locations distant from the sources of its release are of potential concern, monitoring data show that long-range environmental transport of the active substance, safener or synergist, with the potential for transfer to a receiving environment, may have occurred via air, water or migratory species, or environmental fate properties and/or model results demonstrate that the active substance, safener or synergist has a potential for long-range environmental transport through air, water or migratory species, with the potential for transfer to a receiving environment in locations distant from the sources of its release. For an active substance safener or synergist that migrates significantly through the air, its DT50 in air is to be greater than 2 days.
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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.