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

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European Chemicals Bureau

Risk Assessment - New and Existing Substances Risk Assessment - New and Existing Substances

ECB INFODAYS, ZAGREB CROATIA

11-13th December 2006

EuropeanChemicals Bureau

Sharon Munn

European Commission, DG JRC, Institute for Health and Consumer Protection,


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Current Legislation on RA of Exist. Subst.Current Legislation on RA of Exist. Subst.

Council Regulation EEC 793/93 « ESR » Evaluation & Control Risks

Commission Regulation EC 1488/94 RA principles

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3

New vs Existing SubstanceNew vs Existing Substance

Existing Substances 100.195 chemicals 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 SubstancesAre 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)

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Council Regulation EEC 793/93Council Regulation EEC 793/93

4 Steps

1. Data Collection

2. Priority Setting

3. Risk Assessment : Evaluation

4. Risk Reduction : Control (ban, restriction of (ban, restriction of use, ...)use, ...)

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EuropeanChemicals BureauTasksTasks

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

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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 793/93Tools to implement Regulation 793/93 (I) (I)

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1. Data Collection HEDSET (Harmonized Electronic Data SET).

IUCLID (International Uniform ChemicaL Information Database)

Tools to implement Regulation 793/93 (II)Tools to implement Regulation 793/93 (II)

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1. Data Collection : HEDSET, IUCLID

2. Priority Setting EURAMEU Ranking Method

Implementation Tools of Regulation 793/93

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1. Data Collection HEDSET, IUCLID

2. Priority Setting EURAM

3. Risk Assessment TGD – RA http://ecb.jrc.it/tgd/

ESIS http://ecb.jrc.it/esis/

EUSES http://ecb.jrc.it/Euses/

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EuropeanChemicals BureauTechnical Guidance Document Technical Guidance Document

on Risk Assessmenton Risk Assessment

http://ecb.jrc.it/Documents/TECHNICAL_GUIDANCE_DOCUMENT/

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Risk Assessment Risk Assessment Tasks Tasks

1. Maintaining and further developing Tools: o EUSES o ESIS o TGD

2. Reports: MS Rapporteur prepares a draft RAR Discussion in TCNES with all stakeholders (MS, IND, NGO’s,…) Agreement on final RAR Opinion of SCHER (Scientific Committee on Health and Environmental

Risks) Preparing a Commission proposal on the Risk Assessment Publish the finalised RAR

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1. Hazard identification

2. Dose (concentration) – Response (effect) relationship

3. Exposure Assessment

4. Risk characterisation

RISK ASSESSMENT – COM Reg 1488/94

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EuropeanChemicals BureauCom Reg (EC) 1488/94 onCom Reg (EC) 1488/94 on

RA for Existing Substances RA for Existing Substances protection of ENV compartments

aquatic ecosystem (freshwater/marine)

terrestrial ecosystem

top predators

micro-organisms in STP

atmosphereHuman populations

workers

consumers

man exposed via the environment

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Risk characterisationRisk characterisation

Human Health

Margin Of Safety = No Observed Adverse Effect Level Exposure

Environment Predicted Environmental Concentration = PEC Predicted No Effect Concentration PNEC

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Conclusions of the risk assessmentConclusions 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

1,PNECPEC

min.MOS;MOS

1PNECPEC

min.MOS;MOS

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• 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)2 require further information (conclusion i)

http://ecb.jrc.it/

Progress on RARProgress on RAR

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1. Data Collection HEDSET, IUCLID

2. Priority Setting EURAM

3. Risk Assessment TGD - RA, EUSES

4. Risk Reduction TGD - RR

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Risk Management MeasuresRisk 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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+ +

IUCLID Industry

HEDSET

National Prioritities

Risk Assessment report

Priority list

Technical Meeting ECB, MS, IND, NGO

Risk Reduction Meeting

Article 15 Committee

Risk Assessment Draft

Risk reduction Strategy Draft

Risk reduction Strategy

Member States

ECB