Environmental Review, 15/2004 – List of Undesirable Substances 2004 – Appendix C - Criteria for identification of persistent, bioaccumulative and toxic substances (PBT) and very persistent and very bioaccumulative substances (vPvB)

List of Undesirable Substances 2004

Appendix C - Criteria for identification of persistent, bioaccumulative and toxic substances (PBT) and very persistent and very bioaccumulative substances (vPvB)

PBT/vPvB substances are defined in the proposal for a new regulatory framework for chemicals recently published by the European Commission ^[6].

A substance that fulfils all three of the criteria of the section below is a PBT substance. The criteria are not to be used on non-organic compounds, but on organo-metal compounds.

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 estuary water is higher than 40 days, or
the half-life in a marine sediment is higher than 180 days, or
the half-life in a fresh- or estuary 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 must be based on available half-life data collected under adequate conditions, which must be described by the registrant.

Bioaccumulation

A substance fulfils the bioaccumulation criterion (B-) when:

the bioconcentration factor (BCF) is higher than 2,000

The assessment of bioaccumulation must be based on measured data on bioconcentration in aquatic species. Data from fresh water as well as marine water species can be used.

Toxicity

A substance fulfils the toxicity criterion (T-) when:

the long term no-observed effect concentration – (NOEC) - for marine or fresh water 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 to reproduction (category 1, 2 or 3), or
there is any other evidence on chronic toxicity as identified by the classifications: T, R48 or Xn, R48 under Directive 67/548/EEC.

vPvB substances

A substance that fulfils the criteria mentioned below is a vPvB substance:

Persistence

A substance fulfils the "very persistent" criterion (vP-) when:

the half-life in marine, fresh- or estuary water is higher than 60 days, or
the half-life in marine, fresh- or estuary water sediment is higher than 180 days, or
the half-life in soil is higher than 180 days.

Bioaccumulation

A substance fulfils the "very bioaccumulative" criterion (vB-) when:

the bioconcentration factor is greater than 5,000

Footnotes

[6] Proposal for a regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) {on Persistent Organic Pollutants}, which has been published by the European Commission on the website: http://europa.eu.int/eur-lex/en/com/pdf/2003/act0644en03/6.pdf