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Risk Assessment for Existing and New Chemical Substances: Current Legislation and Implementation Tools

This article provides an overview of the current legislation and risk assessment process for existing and new chemical substances in Europe. It discusses the steps involved in data collection, priority setting, risk assessment, and risk reduction. The article also highlights the tools and resources available for implementing the regulations.

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Risk Assessment for Existing and New Chemical Substances: Current Legislation and Implementation Tools

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  1. European Chemicals Bureau Risk Assessment - New and Existing Substances ECB INFODAYS, ZAGREB CROATIA11-13th December 2006 Sharon Munn European Commission, DG JRC, Institute for Health and Consumer Protection, European Chemicals Bureau

  2. Current Legislation on RA of Exist. Subst. • Council Regulation EEC 793/93 « ESR » Evaluation & Control Risks • Commission Regulation EC 1488/94 RA principles

  3. New vs Existing Substance Existing Substances 100.195chemicals which were present on the EC Market before 18th September 1981. 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) 3

  4. Council Regulation EEC 793/93 4 Steps 1. Data Collection 2. Priority Setting 3. Risk Assessment : Evaluation 4. Risk Reduction :Control (ban, restriction of use, ...)

  5. Tasks • Data collection: updating data submitted by Industry into IUCLID database • Priority setting:PBT Working Group identifies substances of high concern • 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) • 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

  6. Tools to implement Regulation 793/93 (I) 1. Data Collection Step HEDSET, IUCLID 2. Priority Setting Step EURAM 3. Risk Assessment Step TGD - RA, EUSES 4. Risk Reduction Step TGD - RR

  7. Tools to implement Regulation 793/93 (II) • Data Collection HEDSET • (Harmonized Electronic Data SET). • IUCLID (International Uniform ChemicaL Information Database)

  8. Implementation Toolsof Regulation 793/93 1. Data Collection : HEDSET, IUCLID 2. Priority SettingEURAM EURanking Method

  9. Implementation Toolsof Regulation 793/93 1. Data Collection HEDSET, IUCLID 2. Priority Setting EURAM 3. Risk AssessmentTGD – RA http://ecb.jrc.it/tgd/ ESIS http://ecb.jrc.it/esis/ EUSES http://ecb.jrc.it/Euses/

  10. Technical Guidance Document on Risk Assessment http://ecb.jrc.it/Documents/TECHNICAL_GUIDANCE_DOCUMENT/

  11. Risk Assessment Tasks

  12. RISK ASSESSMENT – COM Reg 1488/94

  13. 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

  14. Risk characterisation

  15. 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

  16. Progress on RAR • 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) • require further information (conclusion i) • http://ecb.jrc.it/

  17. Implementation Toolsof Regulation 793/93 1. Data Collection HEDSET, IUCLID 2. Priority Setting EURAM 3. Risk Assessment TGD - RA, EUSES 4. Risk ReductionTGD - RR

  18. 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)

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