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Tools for risk assessment: TGDs, EUSES

E uropean C hemicals B ureau. Tools for risk assessment: TGDs, EUSES. Sharon Munn European Commission DG JRC, Institute for Health and Consumer Protection European Chemical Bureau. EU general process. Data collection (step-by-step based on production volume).

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Tools for risk assessment: TGDs, EUSES

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  1. European Chemicals Bureau Tools for risk assessment:TGDs, EUSES Sharon Munn European Commission DG JRC, Institute for Health and Consumer Protection European Chemical Bureau ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  2. EU general process Data collection (step-by-step based on production volume) Automatic priority setting Management committee National priority lists EU priority list in official journal Hazard Assessment Further data gathering and/or risk assessment Exposure Assessment Risk management; (if necessary) incl. strategies for risk reduction ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  3. Tools to implement Regulation 793/93 1. Data Collection Step HEDSET, IUCLID 2. Priority Setting Step EURAM 3. Risk Assessment Step TGD - RA, EUSES 4. Risk Reduction Step TGD - RR T D G ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  4. ENVIRONMENT additional studies birds bioaccumulation prolonged fish earthworms higher plants Daphnia, 21-days algal growth acute Daphnia acute fish bacterial inhibition adsorption/desorption biodegradation 1000 t/a bioaccumulation prolonged fish earthworms higher plants Daphnia, 21-days algal growth acute Daphnia acute fish bacterial inhibition adsorption/desorption biodegradation 10 / 100 Data requirements for new substances algal growth acute Daphnia acute fish bacterial inhibition adsorption/desorption biodegradation 1 Biodegradation 0.1 none 0.01 ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  5. Comparison of the Data Requirements Today: New Substances Existing substances REACH: All Substances 0.01 0.1 1 10 100 1000 t/a ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  6. Implementation Tools of Regulation 793/93 • Data Collection HEDSET • IUCLID ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  7. Tools to implement Regulation 793/93 1. Data Collection Step HEDSET, IUCLID 2. Priority Setting Step EURAM 3. Risk Assessment Step TGD - RA, EUSES 4. Risk Reduction Step TGD - RR ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  8. General Process • Priority setting: • Production volume only, e.g. OECD HPV Chemicals Programme (currently 5235 substances on OECD HPV List) • Risk based priority setting system e.g. ESR (EURAM), PBT Chemicals, WFD, • According to use only (BPD) ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  9. Priority Setting Existing Substances 140 Priority Substances > 2000 HPVCs > 100.000 EINECS substances ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  10. Priority lists: factors which should be taken into account • the effects of the substance to man or the environment; • the exposure of man or the environment to the substance; • the lack of data on the effects of the substance on man and the environment; • work already carried out in other fora; • other Community legislation and/or programmes relating to dangerous substances. ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  11. EURAM using IUCLID data Substance may obtain high scores if, for example • it is produced in large volumes • is used in a dispersive manner • persists in the environment • is highly toxic to humans, animals or plants • has long term/chronic effects • is carcinogenic, mutagenic or toxic to reproduction(CMR) • little is known about its properties,use or effects ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  12. EURAM ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  13. Part I General Introduction Human Health Part II Environment Part III Use of (Q)SARs, Use categories, … Part IV Emission Scenario Documents Principles for risk assessment Free available on ECB web page http://ecb.jrc.it/tgdoc ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  14. Introduction of : Instrument for the quantitative assessment of the risks posed by new and existing chemical substances and biocides to man and the environment. ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  15. EUSES is a coordinated effort of: • EU Member States • The European Commission (DG ENV) • The European Chemicals Bureau (JRC-ECB) • The European Chemical Industry ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  16. Data evaluation Basic Framework of Risk Assessment Process Exposure assessment Effects assessment Data set Single species toxicity data Emission rates TGD Extrapolation Distribution EUSES PNEC PEC Risk characterization PEC/PNEC ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  17. Exposure assessment Effects assessment Release Extrapolation to PNECs/MOS Effects assessment STP Workplace exposure Local distribution Regional distribution Route-to-route extrapolation Consumer exposure Exposure of humans/predators Hydrocarbon Block Method Risk characterisation Modules of EUSES ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  18. ARCTIC MODERATE TROPIC CONTINENT REGION LOCAL ENVIRONMENT air exchange exchange background concentrations water inflow water concentrations natural soil agricultural soil water sediment natural soil agricultural soil industrial soil sediment Spatial scales of EUSES ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  19. deposition agricultural grassland soil volatilization leaching sludge application groundwater dilution surface water sedimentation sediment Local emission and distribution ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  20. Emission Scenario Documents TDG Part IV • IC-3 Chemical industry: Chemicals used in synthesis • IC-5 Personal/Domestic and IC-6 Public domain • IC-10 Photographic industry • IC-12 Pulp, paper and board industry • IC-13 Textile processing industry • IC-14 Paints, lacquers and varnished industry • BPT-9 Biocides used as preservatives • BPT-6,7&9 Biocides used as preservatives in paper coating and finishing • BPT 2 Private and public health area disinfectants and other biocidal products • ….. ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  21. PT Description 10 Masonry preservatives 11 Liquid-cooling and processing preservatives- cooling systems 12 Slimicides- paper pulp- mineral oil extraction 13 Metal working fluids preservatives 14 Rodenticides 15 Avicides 18 Insecticides 21 Antifouling NEW Emission Scenarios Documents updating EUSES PT Description 1 Human hygiene biocidal products 5 Drinking water disinfectants 6 In-can preservatives- washing & cleaning fluids- paints & coatings- fluids for paper, textile & leather prod. 7 Film preservatives- plastics- paper & cardboard 8 Wood preservatives 9 Fibre, leather, rubber and polymer preservatives- textiles & fabrics- leather & hides- paper & cardboard- rubber, polymers, etc. ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  22. Non AvailableEmission Scenarios Documents and the Biocides Product Directive PT Description 3 Veterinary hygiene 4 Food and feed area 16 Molluscicides 17 Piscicides 19 Repellents and attractants 20 Preservatives for food and feedstocks 23 Control of other vertebrates ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  23. Environmental emission scenarios • Training Course Materials in ECB website: http://ecb.jrc.it/biocides/ESDs ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  24. Parameter value unit Density of the solid pahse 2500 kgsolid/msolid3 Density of the water phase 1000 kgwater/mwater3 Density of air 1.3 kgair/mair3 Temperature 12 ºC Surface water [Suspended matter] 15 mgsolid/lwater Suspended matter Fraction solids in s.matter 0.1 msolid3/msusp3 Fraction water in s.matter 0.9 mwater3/msusp3 Fraction o.c. in s.matter 0.1 Kgoc/kgsolid Sediments Fraction solids in sed. 0.2 msolid3/msed3 Fraction water in sed. 0.8 mwater3/msed3 Fraction o.c. in sed. solids. 0.05 Kgoc/kgsolid Soil Fraction solids in soil 0.6 msolid3/msed3 Fraction water in soil 0.2 mwater3/msed3 Fraction o.c. in soil 0.02 Kgoc/kgsolid Fraction o.m. in soil 0.034 Kgoc/kgsolid ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  25. Regional distribution ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  26. Environment air water food soil Consumer products Occupational environment dermal inhalation oral Human exposure: pathways ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  27. Air crops HUMANS dairy products Soil cattle meat Groundwater drinking water Surfacewater fish Human indirect exposure routes ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  28. Exposure assessment Effects assessment Release Extrapolation to PNECs/MOS Effects assessment STP Workplace exposure Local distribution Regional distribution Route-to-route extrapolation Consumer exposure Exposure of humans/predators Hydrocarbon Block Method Risk characterisation Modules of EUSES ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  29. Existing ChemicalsGeneral decision scheme PEC/PNEC > 1 Decision Scheme NO no need for further testing or risk reduction YES can further info lower PEC/PNEC? NO Risk Reduction Measures YES further testing to lower PEC or PNEC ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  30. Limitations of EUSES • A model is always a “cartoon of reality” • Chemical risk policy of the EC • Model analysis and validation limited • Expertise of user is important • data evaluation (“garbage in - garbage out”) • interpretation of results ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  31. Tools for Risk Assessment of Chemicals IUCLID4International Uniform Chemical Information DatabaseTGDTechnical Guidance DocumentsEUSES Available to download for free at ECB website:http://ecb.jrc.it/documents ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  32. What have we learned from using the TGD? • THEOREM: • Where there is “Clear guidance” there is less discussion • Where there is “Some guidance” there is more discussion • Where there is “Little Guidance” there is lots of discussion • CORROLARY: • The more discussion the more room for inconsistent decisions and the slower the decision making ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  33. TGD and EUSES under REACH ? • Basic principles will apply • Industry will have to demonstrate safe use of chemicals through Risk Assessment • Manufacturers/Importers vs (Downstream) Users: who does what • Challenge to develop appropriate guidance • Use of QSARs and category approaches ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

  34. REACH information available on: • ECB, European Chemicals Bureau http://ecb.jrc.it/REACH • CLEEN, Chemicals Legislation European Enforcement Network • http://www.cleen-eu.net • DG Enterprise: REACH • http://europa.eu.int/comm/enterprise/reach • DG Enterprise: REACH calls for tender • http://europa.eu.int/comm/enterprise/reach/calls.htm • DG Environment: REACH • http://europa.eu.int/comm/environment/chemicals/reach.htm ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

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