-REACH - Hazard Data: Requirements and Closing Gaps

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1 -REACH - Hazard Data: Requirements and Closing Gaps Presented By: Tony Mallett Experien Health Sciences Houston London Philadelphia Cincinnati

2 What s changed with REACH? Manufacturers and importers must: - provide data on their substances - use this information to assess risks - develop appropriate risk management measures Paradigm shift: - manufacturers and importers comply - Authorities evaluate and enforce

3 No data, no market

4 General data requirements Increase with volume: - thresholds = 1, 10, 100 and 1000 tonnes/yr Trigger-points reflect intrinsic hazard: - carcinogenic, mutagenic, reprotoxic (CMR) - persistant, bioaccumulative, very toxic (PBT)

5 Requirements for 1-10 t/yr Annex VII = 1-10 t/yr - phys-chem properties around 12 end-points e.g. FPt, BPt, VP etc - limited tox information skin/eye irritation (desk-top, in vitro), sensitization, bacterial mutation (Ames), acute oral - limited ecotox information daphnia, algae, biodegradation

6 Requirements for t/yr Annex VIII = t/yr as Annex VII, plus - supplemental tox information skin/eye irritation (in vivo), mammalian cell mutagenicity, second route acute tox, 28-day repeat dose, repro/dev screen (OECD 421 or 422), toxicokinetics (desktop) - supplemental ecotox information fish, sludge inhibition, abiotic degradation, adsoprtion/desorb

7 Requirements for t/yr Annex IX = t/yr as Annex VII+VIII, plus case-by-case need for - supplemental phys-chem information stability, dissociation, viscosity - further tox data in vivo genetox, 90-day repeat dose tox, full repro/dev testing - further ecotox data long-term daphnia, fish early life-stage, bioaccumulation, terrestrial organism effects, additional fate studies, methods for environmental detection and analysis

8 Requirements for t/yr Annex X = t/yr: as Annex VII+VIII+IX, plus case-by-case need for - further tox data studies to address serious/severe effects e.g. second in vivo genetox test, 104-week repeat dose/cancer - further fate/behaviour data focus on long-term effects, terrestrial and sediment organisms, birds etc

9 Recap Data requirements increase with - volume - seriousness of hazard with potential (testing / cost) consequences for manufacturers and importers

10 But Data requirements increase with - volume Automatic in vivo testing is not expected - seriousness Consider all of currently hazard available data with Review (testing options / cost) for consequences exemption or for manufacturers adaptation of standard importers requirements

11 Specific rules for adaptation Physio-chemical information - some unnecessary due to substance characteristics (Eco)toxicological information - some unnecessary due to substance characteristics - others unnecessary due to presence of hazards of greater concern

12 Example: phys-chem data

13 Example: health effects data

14 Adaptation using Annex XI General rules for adaptation of the standard testing regime

15 Annex XI principles General rules for adaptation of standard requirements: - not scientifically necessary - technically not possible - exposure-driven waiving

16 Not scientifically necessary Use of existing data - results from non-glp ( older ) studies - epidemiology / occupational information - weight of evidence Alternative methods -QSAR - in vitro tests Grouping and read-across

17 Not scientifically necessary Use of existing data - results from non-glp ( older ) studies - epidemiology / occupational information - weight of evidence Alternative methods -QSAR - in vitro tests Grouping and read-across

18 Not scientifically necessary Use of existing data - results from non-glp ( older ) studies - epidemiology / occupational information - weight of evidence Alternative methods -QSAR - in vitro tests Grouping and read-across

19 Not technically possible Consequence of substance properties - self evident

20 Exposure-driven waiving Impacts repeat and reprotox testing at >10 t/yr bands Based on exposure scenarios - from CSA/CSR Adequate justification and documentation shall be provided - guidance to follow

21 Practical option: SIEF Data sharing possible: - Substance Information Exchange Fora - potential to formally share at reasonable cost Critical point: - only manufacturers/importers of Pre-registered substances eligible

22 Other requirements Light registration for some intermediates - strict definitions and controls apply - if met, limited information required - if transported at >1000 t/yr, Annex VII applies

23 Other requirements Substances in articles - substances intended for release must be registered at 1 t/yr - SVCH present at 0.1% w/w used in article at 1 t/yr must be notified to Agency - registration may be required if risks apparent

24 Conclusions Manufacturers and importers must provide data in order to assess and manage risks - No data, no market Extent of information required dependent on - volume - intrinsic hazard Standard requirements can be modified - adaptation

25 Conclusions Cost mitigation possible via SIEFs - essential to Pre-register Act soon: ask yourself - what do you have (inventorize) - what do you need (compare) - how will you fill gaps (test or adapt)