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ANNEX XIII: CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES
This Annex lays down the criteria for the identification of:
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.
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 2000.
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 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2, or 3), or
- there is other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.
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 5000.
Referred by:
ARTICLE 14: Chemical safety report and duty to apply and recommend risk reduction measures
ARTICLE 31: Requirements for safety data sheets
ARTICLE 57: Substances to be included in Annex XIV
ARTICLE 138: Review
ANNEX I: GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS
ANNEX II: GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS
ANNEX III: CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES
ANNEX XV: DOSSIERS