Regulation (EC) No 1107/2009 of the European Parliament and of the CouncilShow full title

3.7. Fate and behaviour in the environment U.K.

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). U.K.

A substance that fulfils all three of the criteria of the points below is a POP.

3.7.1.1. Persistence U.K.

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.

3.7.1.2. Bioaccumulation U.K.

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 5 000 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.

3.7.1.3. Potential for long-range environmental transport: U.K.

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.

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. U.K.

A substance that fulfils all three of the criteria of the points below is a PBT substance.

3.7.2.1. Persistence U.K.

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.

3.7.2.2. Bioaccumulation U.K.

An active substance, safener or synergist fulfils the bioaccumulation criterion where the bioconcentration factor is higher than 2 000.

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.

3.7.2.3. Toxicity U.K.

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.

3.7.3. An active substance, safener or synergist shall only be approved if it is not considered to be a very persistent and very bioaccumulative substance (vPvB). U.K.

A substance that fulfils both of the criteria of the points below is a vPvB substance.

3.7.3.1. Persistence U.K.

An active substance, safener or synergist fulfils the ‘very persistent’ criterion where:

• the half-life in marine, fresh- or estuarine water is higher than 60 days,

• the half-life in marine, fresh- or estuarine water sediment is higher than 180 days, or

• the half-life in soil is higher than 180 days.

3.7.3.2. Bioaccumulation U.K.

An active substance, safener or synergist fulfils the ‘very bioaccumulative’ criterion where the bioconcentration factor is greater than 5 000.