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According to section 4 of Annex I of the REACH Regulation which has been in force since June 1, 2007, the assessment of the property of a chemical substance or its mixtures to be persistent (P), bioaccumulative (B) and toxic (T) to living beings and the environment; as well as being very persistent (vP) and very bioaccumulative (vB), its objective is to determine whether the substance evaluated meets the criteria required in Annex XIII of the regulation.
A PBT/vPvB assessment is required for all substances for which a CSA must be conducted and reported in the Chemical Safety Report (CSR). These are, according to Article 14(1) of the REACH regulation, in general all substances manufactured or imported in quantities greater than 10 tonnes per year. However, exceptions apply, as described in Article 14(2), for substances present in a mixture in concentrations lower than 0.1% (m/m) (ECHA Guidance on Information Requirements and Chemical Safety Assessment; Chapter R.11: PBT/ vPvB assessment;
Table 1. Criteria for PBT and vPvB according to Section 1 of Annex XIII of the REACH regulation (reference: Table R.11-1, pg. 17).
| Property | PBT Criterion | vPvB Criterion |
| Persistent (P) | A substance meets the persistent (P) criterion in any of the following situations if:
(a) Degradation half-life in seawater > 60 days; (b) The degradation half-life in fresh water or estuaries is > 40 days; (c) The degradation half-life in marine sediment is > 180 days; (d) The degradation half-life in fresh water or estuary sediments is > 120 days; (e) The degradation half-life in soils is > 120 days. |
A substance meets the “very persistent” (vP) criterion in any of the following situations if:
(a) The half-life of degradation in marine, fresh or estuary water is > 60 days; (b) The half-life of degradation in marine sediment, fresh water or estuaries is > 180 days; (c) The degradation half-life in soils is > 180 days. |
Table 1. Continuation
| Property | PBT Criterion | vPvB Criterion |
| Bioaccumulation | A substance meets the bioaccumulation criterion (B) when the bioconcentration factor in aquatic species is > 2000. | A substance meets the “very bioaccumulative” (vB) criterion when the bioconcentration factor in aquatic species is > 5000. |
| Toxicity | The substance meets the toxicity criterion (T) in either situation if:
(a) The no observed long-term effect concentration (NOEC) or EC10 for marine or freshwater organisms is < 0.01mg/L; (b) The substance meets the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A and 1B) in accordance with regulation (EC) No. 1272/2008. |
ND |
ND: not described.
Table 2. Screening information as listed in Section 3.1 of Annex XIII of the REACH regulation. (reference Table R.11-2; pg. 18).
| Indication of P and vP properties | (a) Results of immediate biodegradation tests in accordance with Section 9.2.1.1 of Annex VII;
(b) Results of other tests (e.g. enhanced immediate biodegradability test, inherent biodegradability tests; (c) Results obtained by (Q)SAR biodegradation models in accordance with Section 1.3 of Annex XI; (d) Other information, provided that its reliability can be reasonably demonstrated. |
| Indication of B and vB properties | (a) Octanol-water partition coefficient in accordance with Section 7.8 of Annex VII or estimated by (Q)SAR models in accordance with section 1.3 of Annex XI;
(b) Other information, provided that its reliability can be reasonably demonstrated. |
| Indication of T properties | (a) Short-term aquatic toxicity in accordance with Section 9.1 of Annex VII and Section 9.1.13 of Annex VIII;
(b) Other information, provided that its reliability can be reasonably demonstrated. |
Table 3. Information for assessment according to Section 3.2 of Annex XIII of the REACH regulation. (reference Table R.11-3, pg. 19).
| Evaluation of P or vP properties | (a) Results of simulated degradation tests on the water surface;
(b) Results of simulated soil degradation tests; (c) Results of simulated degradation tests in sediment; (d) Other information, such as monitored studies, provided that their reliability can be reasonably demonstrated. |
| Rating of B or vB | (a) Results of a bioconcentration or bioaccumulation study in aquatic species;
(b) Other information on bioaccumulation potential, provided that its suitability and reliability can be reasonably demonstrated, such as: – results of studies on bioaccumulation in terrestrial species; – data from scientific analyzes of tissues and fluids from the human body, such as blood, bed or fat; – detection of elevated levels in biota, in particular in threatened species or vulnerable populations, compared to levels in their surrounding environment; – results of chronic toxicity studies in animals; – assessment of the toxicokinetic behavior of the substance; (c) Information on the biomagnification capacity of the substance in the food chain, whenever possible expressed by trophic amplification factors. |
| T property assessment | (a) Results of long-term toxicity tests on invertebrates, as established in Section 9.1.5 of Annex IX;
(b) Results of long-term toxicity tests on fish as described in Section 9.1.6 of Annex IX; (c) Results of growth inhibition studies on aquatic plants as set out in Section 9.1.2 in Annex VII; (d) The substance that meets the criteria for classification as carcinogenic in category 1A and 1B (assigned hazard statements: H350 or H350i), germ cell mutagenic in category 1A or 1B (assigned hazard statements: H340), toxic for reproduction in Category 1A, 1B and/or 2 (assigned hazard statements: H360, H360F, H360D, H360FD, H360Fd, H360 fD, H361, H361f, H361d or H361fd), toxic to a specific target organ after repeated dose in Category 1 or 2 (assigned hazard phrase: H372 or H373), in accordance with EC Regulation No. 1272/2008; (e) Long-term reproductive toxicity results in birds as set out in Section 9.6.1 of Annex X; (f) Other information, provided that its reliability can be reasonably demonstrated. |
OECD: International Trade and the Transition to a Circular Economy (Recycle: resource efficiency and circular economy project)
The expected benefits of a circular economy transition include:
- reduction in the extraction of virgin natural resources
- reduced exposure to supply risk (geopolitical)
- reducing environmental pressures
- new economic and employment opportunities
- synergies with a low-carbon transition