JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau Risk Assessment - New and Existing Substances Risk Assessment - New and Existing Substances.

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Presentation transcript:

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau Risk Assessment - New and Existing Substances Risk Assessment - New and Existing Substances ECB INFODAYS, ZAGREB CROATIA th December 2006 European Chemicals Bureau Sharon Munn European Commission, DG JRC, Institute for Health and Consumer Protection, European Chemicals Bureau

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals Bureau Current Legislation on RA of Exist. Subst.  Council Regulation EEC 793/93 « ESR » Evaluation & Control Risks  Commission Regulation EC 1488/94 RA principles

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals Bureau 3 New vs Existing Substance Existing Substances chemicals which were present on the EC Market before 18th September Existing Substances are listed in EINECS (European INventory of Existing Commercial chemical Substances ) New Substances Are all substances placed on the EC Market after 18th September 1981 are New Substances and are listed in ELINCS (European List of Notified Chemical Substances)

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals Bureau Council Regulation EEC 793/93 4 Steps 1. Data Collection 2. Priority Setting 3. Risk Assessment : Evaluation (ban, restriction of use,...) 4. Risk Reduction : Control (ban, restriction of use,...)

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals BureauTasks 1. Data collection: updating data submitted by Industry into IUCLID database 2. Priority setting: PBT Working Group identifies substances of high concern 3. Risk assessment: Technical Committee (4/year) agrees on the RA of 141 prioritized ES Results of RA submitted to DG ENV (Commission Recommendations) Report published on the ECB website : 64 ( http//ecb.jrc.it ) 4. Risk management : support to DG ENV on activities following the identification of risks +harmonisation with International programmes (e.g. OECD/WHO/UNEP) +continuous development of guidance and tools

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals Bureau 1. 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 (I)

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals Bureau 1.Data Collection HEDSET (Harmonized Electronic Data SET). IUCLID ( International Uniform ChemicaL Information Database) Tools to implement Regulation 793/93 (II)

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals Bureau 1. Data Collection : HEDSET, IUCLID 2. Priority Setting EURAM EU Ranking Method Implementation Tools of Regulation 793/93

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals Bureau Implementation Tools of Regulation 793/93 1. Data Collection HEDSET, IUCLID 2. Priority Setting EURAM 3. Risk Assessment TGD – RA ESIS EUSES

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals Bureau Technical Guidance Document on Risk Assessment GUIDANCE_DOCUMENT/

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals Bureau

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals Bureau

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals Bureau Risk Assessment Tasks

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals Bureau RISK ASSESSMENT – COM Reg 1488/94

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals Bureau Com Reg (EC) 1488/94 on RA for Existing Substances  protection of ENV compartments aquatic ecosystem (freshwater/marine) terrestrial ecosystem top predators micro-organisms in STP atmosphere  Human populations workers consumers man exposed via the environment

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals Bureau Risk characterisation

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals Bureau Conclusions of the risk assessment (i)There is a need for further information and/or testing (ii)There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals Bureau 131 RAR completed (on 141) 71 RAR agreed for ENV + HH + 17 RAR ENV + 19 RAR HH 11 with no concern (conclusion ii) 59 need risk reduction measures (conclusion iii) 2require further information (conclusion i) Progress on RAR

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals Bureau Implementation Tools of Regulation 793/93 1. Data Collection HEDSET, IUCLID 2. Priority Setting EURAM 3. Risk Assessment TGD - RA, EUSES 4. Risk Reduction TGD - RR

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals Bureau Risk Management Measures  Voluntary agreements (IND)  National rules to control local emissions (MS)  Non binding guidance (Commission)  Community legislation (EC) Restrictions in marketing and use (DG ENTR) Occupational Exposure Limits (DG EMPL) Emission Limit Values, Water Quality Standards (DG ENV)  EU Council decisions on International conventions (UN, OSPAR Convention)

JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Chemicals Bureau European Chemicals Bureau