[X1ANNEX XIII U.K. CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES
Editorial Information
X1Substituted by Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Official Journal of the European Union L 396 of 30 December 2006).
This Annex lays down the criteria for the identification of:
persistent, bioaccumulative and toxic substances (PBT-substances), and
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 U.K.
A substance that fulfils all three of the criteria of the sections below is a PBT substance.
1.1. Persistence U.K.
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 U.K.
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 U.K.
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.
2. vPvB-SUBSTANCES U.K.
A substance that fulfils the criteria of the sections below is a vPvB substance.
2.1. Persistence U.K.
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 U.K.
A substance fulfils the very bioaccumulative criterion (vB-) when:
the bioconcentration factor is greater than 5 000 .]