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. 2019 Apr 5;17(4):e05648. doi: 10.2903/j.efsa.2019.5648

Table E.2.

PBT and vPvB criteria according to ECHA (2017e) Guidance on information requirements and chemical safety assessment, Part C: PBT/vPvB assessment

Property PBT‐criteria vPvB‐criteria
Persistence

A substance fulfils the persistence criterion

(P) in any of the following situations:

  • T1/2 > 60 days in marine water;
  • T1/2 > 40 days in fresh‐ or estuarine water;
  • T1/2 > 180 days in marine sediment;
  • T1/2 > 120 days in fresh‐ or estuarine sediment;
  • T1/2 > 120 days in soil.

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

  • T1/2 > 60 days in marine, fresh‐ or estuarine water;
  • T1/2 > 180 days in marine, fresh‐ or estuarine sediment;
  • T1/2 > 180 days in soil.
Bioaccumulation A substance fulfils the bioaccumulation criterion (B) when: BCF > 2000 A substance fulfils the “very bioaccumulative” criterion (vB) when: BCF > 5000
Toxicity

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

  • NOEC or EC10 < 0.01 mg/L for marine or freshwater organisms;
  • 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);
  • 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 the CLP Regulation