1. Summary Slide Some Industry views on POP/PBT identification in Europe

2. Dr Dolf van Wijk – Euro Chlor Manager Environmental Sciences Some Industry views on POP/PBT identification in Europe

3. Contents: The industry perspective Learnings from Europe – PBT exercise: - Identification of T - Identification of B – proposal - Identification of P - proposal

4. POP identification Different criteria in different legislations Different interpretations of data versus criteria Oversimplification in regulations: e.g. not ready = persistent; Hazard based, how to include risk?

5. Identification as Toxic In Europe usually not very controversial: Test validity well described and agreed (Klimisch criteria) Multiple data interpretation clear: - lowest value used - penalising data-rich substances Criteria (LC 50, NOEC) are test endpoints

6. Identification as Bioaccumulative Tests less standardised, less experience, more costly Proposal: evaluate according to OECD and define validity criteria (equilibrium- recovery, etc.) Multiple data interpretation, e.g.: - 10 values; 2 are 5500; 8 are below? - Weight of fish, bacteria, algae, etc.? Proposal: weight of evidence Criteria are test endpoints: BCF is measured (but often only surrogate logK ow is available)

7. Identification as Persistent For water: no tests exist: use (bio)degradation tests and other evidence + careful interpretation Multiple tests: like in C&L positive test usually taken Criteria are (mostly) not test endpoints; extrapolation to the environment extremely difficult

8. Persistency half-lives Half-lives for persistency are the result of many complex interactions and conditions: ‘A common finding is that biogeochemical processes in the receiving environment are as crucial to the manifestation of persistence as are the chemical properties themselves’ Pellston workshop on POPs (Setac, 1999)

10. Substance Passes ready biodegradation test (OECD 301) Any other data Yes CAS, soil, marine (OECD 303; OECD 304; OCED 306) Inherent (OECD 302; OECD 301-equivalent with adapted sludge) Other evidence (non-standard; pure cultures; etc.) Accept categorisation: stop or refine: further data No Yes No Abiotic degradation (OECD 111; OECD Mongraph 7; OPPTS equivalents) 1 P2 P2 P1 P2 P1 P4 P1 YesNoRate and extent?NoYes 2 P2 1 Classified as P2 due to the presence of metabolites or bound residues 2 Achieved 70% degradation outside the guidance outlined in the TGD (Section 2.3.6.4) YesNo P4P3

11. Substance Passes ready biodegradation test 1 Any other data 2 Distribution model – Level II or III 6 No Yes CAS, soil 4 or marine Inherent 5 Other evidence P4 Accept categorisation: stop or refine: further data Identify compartment(s) of interest No Aquatic/ Marine 7,8 Water/ Sediment 7 Soil 7 Air Evidence of biodegradation: biotic and/or abiotic degradation Yes No Abiotic degradation 3 P2 P1 P2 P1 P2 P1 P2 P1 Default P4P3 Screening Stage Confirmatory Stage P3 No concern P2 P1