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

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

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

ECB INFODAYS Zagreb, Croatia, December 2006 ENVIRONMENT Data requirements for new substances none 0.01 Biodegradation 0.1 algal growth acute Daphnia acute fish bacterial inhibition adsorption/desorption biodegradation 1 bioaccumulation prolonged fish earthworms higher plants Daphnia, 21-days algal growth acute Daphnia acute fish bacterial inhibition adsorption/desorption biodegradation 10 / 100 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

ECB INFODAYS Zagreb, Croatia, December t/a Today: New Substances REACH: All Substances Existing substances Comparison of the Data Requirements

ECB INFODAYS Zagreb, Croatia, December Data Collection HEDSET IUCLID Implementation Tools of Regulation 793/93

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

ECB INFODAYS Zagreb, Croatia, December 2006 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) General Process

ECB INFODAYS Zagreb, Croatia, December 2006 Priority Setting Existing Substances > EINECS substances > 2000 HPVCs 140 Priority Substances

ECB INFODAYS Zagreb, Croatia, December 2006 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, December 2006 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, December 2006 EURAM

ECB INFODAYS Zagreb, Croatia, December 2006 Principles for risk assessment Free available on ECB web page Part I –General Introduction –Human Health Part II –Environment Part III –Use of (Q)SARs, –Use categories, … Part IV –Emission Scenario Documents

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

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

ECB INFODAYS Zagreb, Croatia, December 2006 Spatial scales of EUSES water sediment natural soil agricultural soil CONTINENT LOCAL ENVIRONMENT REGION background concentrations inflow concentrations air water natural soil agricultural soil industrial soil MODERATETROPICARCTIC sediment exchange

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

ECB INFODAYS Zagreb, Croatia, December 2006 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 – ….. Emission Scenario Documents

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

ECB INFODAYS Zagreb, Croatia, December 2006 Non Available Emission Scenarios Documents and the Biocides Product Directive PTDescription 3Veterinary hygiene 4Food and feed area 16Molluscicides 17Piscicides 19Repellents and attractants 20Preservatives for food and feedstocks 23Control of other vertebrates

ECB INFODAYS Zagreb, Croatia, December 2006 Environmental emission scenarios Training Course Materials in ECB website:

ECB INFODAYS Zagreb, Croatia, December 2006 Parametervalueunit Density of the solid pahse2500kg solid /m solid 3 Density of the water phase1000kg water /m water 3 Density of air1.3kg air /mair 3 Temperature12ºC Surface water [Suspended matter]15mg solid /l water Suspended matter Fraction solids in s.matter0.1m solid 3 /m susp 3 Fraction water in s.matter0.9m water 3 /m susp 3 Fraction o.c. in s.matter0.1Kg oc /kg solid Sediments Fraction solids in sed.0.2 m solid 3 /m sed 3 Fraction water in sed.0.8 m water 3 /m sed 3 Fraction o.c. in sed. solids.0.05 Kg oc /kg solid Soil Fraction solids in soil0.6 m solid 3 /m sed 3 Fraction water in soil0.2 m water 3 /m sed 3 Fraction o.c. in soil0.02 Kg oc /kg solid Fraction o.m. in soil0.034 Kg oc /kg solid

ECB INFODAYS Zagreb, Croatia, December 2006 Regional distribution

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

ECB INFODAYS Zagreb, Croatia, December 2006 Human indirect exposure routes Air fish meat dairy products crops drinking water HUMANS cattle Soil Groundwater Surface water

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

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

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

ECB INFODAYS Zagreb, Croatia, December 2006 Tools for Risk Assessment of Chemicals IUCLID4 International Uniform Chemical Information Database TGD Technical Guidance Documents EUSES Available to download for free at ECB website:

ECB INFODAYS Zagreb, Croatia, December 2006 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, December 2006 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, December 2006 REACH information available on: ECB, European Chemicals Bureau CLEEN, Chemicals Legislation European Enforcement Network DG Enterprise: REACH DG Enterprise: REACH calls for tender DG Environment: REACH