BPR and PBT/ vPvB assessment - Biocides

Criteria to identify persistent, bioaccumulative and toxic substances (PBT), persistent organic pollutants (POP) and very persistent very bioaccumulative (vPvB) substances are set out in Annex XIII to Regulation (EC) No 1907/2006.  Substances fulfilling the PBT or vPvB criteria or two out of the three criteria require an environmental risk assessment.  The outcome of the PBT assessment may affect the approval of the substance.  For further details please refer to the BPR.

Persistence assessment

Results from simulation testing on degradation in soil (OECD 307), surface water (OECD 309) and sediment (OECD 308) can be directly compared with the persistence criteria.  However, the degradation half-life for the soil, surface water and sediment compartments must be normalised to 12°C.  Non extractable residues (NERs) must be quantified in all simulation studies.  By default, total (uncharacterised) NER is regarded as non-degraded substance.  However, biogenic NER (bioNER = NER Type III) and strongly bound NER (Type II) can be regarded as removed when calculating the degradation half-life(s) for the PBT/vPvB assessment if there is no indication to the contrary.

Quick Links

PBT assessment

NER Guidance

Improving the interpretation of Non-Extractable Residues (NER) in degradation assessment

Options to address non-extractable residues in regulatory persistence assessment

FOCUS Kinetics

FOCUS guidance on degradation kinetics

Introduction to FOCUS kinetics, Part 1

Introduction to FOCUS kinetics, Part 2: Metabolites

Introduction to FOCUS kinetics, Part 3: Water sediment studies


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