This Annex lays down the criteria for the identification of:
(i) persistent, bioaccumulative and toxic substances (PBT-substances), and
(ii) very persistent and very bioaccumulative substances (vPvB-substances).
A substance is identified as a PBT substance if it fulfils the criteria in Sections 1.1, 1.2 and 1.3. A substance is identified as a vPvB substance if it fulfils the criteria in Sections 2.1 and 2.2. This annex shall not apply to inorganic substances, but shall apply to organo-metals.
1. PBT-SUBSTANCES
A substance that fulfils all three of the criteria of the sections below is a PBT substance.
1.1. Persistence
A substance fulfils the persistence criterion (P-) when:
— the half-life in marine water is higher than 60 days, or
— the half-life in fresh- or estuarine water is higher than 40 days, or
— the half-life in marine sediment is higher than 180 days, or
— 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.
The assessment of the persistency in the environment shall be based on available half-life data collected under the adequate conditions, which shall be described by the registrant.
1.2. Bioaccumulation
A substance fulfils the bioaccumulation criterion (B-) when:
— the bioconcentration factor (BCF) is higher than 2 000.
The assessment of bioaccumulation shall be based on measured data on bioconcentration in aquatic species. Data from freshwater as well as marine water species can be used.
1.3. Toxicity
A substance fulfils the toxicity criterion (T-) when:
— the long-term no-observed effect concentration (Noec) for marine or freshwater organisms is less than 0,01 mg/l, or
— the substance is classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2), or
— there is other evidence of chronic toxicity, as identified by the classifications STOT (repeated exposure), category 1 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) or category 2 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) according to Regulation (EC) No 1272/2008.
2. vPvB-SUBSTANCES
A substance that fulfils the criteria of the sections below is a vPvB substance.
2.1. Persistence
A substance fulfils the very persistence criterion (vP-) when:
— the half-life in marine, fresh- or estuarine water is higher than 60 days, or
— 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.
2.2. Bioaccumulation
A substance fulfils the very bioaccumulative criterion (vB-) when:
— the bioconcentration factor is greater than 5 000.