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 (Text with EEA relevance) (c. 1907)

[X1 [F1 ANNEX XIII U.K. CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES

Editorial Information

X1 Substituted 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).

Textual Amendments

F1 Substituted by Commission Regulation (EU) No 253/2011 of 15 March 2011 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XIII (Text with EEA relevance).

1. CRITERIA FOR THE IDENTIFICATION OF PBT AND vPvB SUBSTANCES U.K.

1.1. PBT Substances U.K.

A substance that fulfils the persistence, bioaccumulation and toxicity criteria of Sections 1.1.1, 1.1.2 and 1.1.3 shall be considered to be a PBT substance.

1.1.1. Persistence U.K.

A substance fulfils the persistence criterion (P) in any of the following situations:

(a)

the degradation half-life in marine water is higher than 60 days;

(b)

the degradation half-life in fresh or estuarine water is higher than 40 days;

(c)

the degradation half-life in marine sediment is higher than 180 days;

(d)

the degradation half-life in fresh or estuarine water sediment is higher than 120 days;

(e)

the degradation half-life in soil is higher than 120 days.

1.1.2. Bioaccumulation U.K.

A substance fulfils the bioaccumulation criterion (B) when the bioconcentration factor in aquatic species is higher than 2 000 .

1.1.3. Toxicity U.K.

A substance fulfils the toxicity criterion (T) in any of the following situations:

(a)

the long-term no-observed effect concentration (NOEC) or EC10 for marine or freshwater organisms is less than 0,01 mg/l;

(b)

the substance meets the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B, or 2) according to Regulation EC No 1272/2008;

(c)

there is other evidence of chronic toxicity, as identified by the substance meeting the criteria for classification: specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008.

1.2. vPvB Substances U.K.

A substance that fulfils the persistence and bioacumulation criteria of Sections 1.2.1 and 1.2.2 shall be considered to be a vPvB substance.

1.2.1. Persistence U.K.

A substance fulfils the ‘ very persistent ’ criterion (vP) in any of the following situations:

(a)

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

(b)

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

(c)

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

1.2.2. Bioaccumulation U.K.

A substance fulfils the ‘ very bioaccumulative ’ criterion (vB) when the bioconcentration factor in aquatic species is higher than 5 000 .] ]