REACH: state of art and base definitionsWERCS 2007 US User group Albany

27/06/2007

Dr. Erwin Annys Sr. Advisor Product & Innovation Policy

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REACH doesn’t come out of the blues

New Substances

Existing Substances 1965. . . . . . .70. . . . . . .75. . . . . . .80. . . . . . .85. . . . . . .90. . . . . . .95. . . . . . .00. . . . . . .03

Existing chemicals regulation

Dir 67/548/EEC: Obligation to label dangerous substances

Reg 793/93/EC: Risk Assessment existing substances

Dir 79/831/EEC – 6th amendmentDir 92/32/EEC – 7th amendmentNotification new substancesList Existing Substances (before 1981)

Safety Data Sheets

White Paper

Accepted commission

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Chronology

Application de la nouvelle réglementation:

1 June 2007

Opinion Commission

Processus internal

Commission

Discussion White book

1999 - Feb. 2001

Edition White book

Feb. 2001Consultation of Stakeholders

2 Avril 2001

PropositionDG Env.DG Entr.Begin 2003

1st lecture Parliament

Common Position of the Council

Parlement 2de Lezing

2nd readingParliament

13 Dec

2006

ConclusionsCouncil

Ideas Parliament

Avril – Nov. 2001

Proposal

29 Oct. 2003

Consultation Internet

May 2003

17 Nov. 2005

13 Dec. 2005

12 June 2006

2nd readingCouncil

18 Dec 2006

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REACH

• Registration

• Evaluation

• Authorisation and restriction

of

• Chemical substances

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Substance – preparation - article

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REACH

Registration

Evaluation

Authorisation

Restriction

Classificationindex

Sharing data

Info insupply chain

Down streamuse

Responsibility industry

Agency

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Registration

• Substances above 1 ton per year

• Not limited to bringing on the market • Producing

• Importing

• Data in function of volume

• Timing in function of volume (and hazard)

• Sharing of data

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Registration

• No data, no market

• Inversement burden of proof-responsibility industry

• Substance and use • Hence new communication in the supply chain

• Avoid testing on vertebrate animals

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What to register?

What to register?

Substances exempted from

registrationSection 1.6.4

Substances regarded as registeredSection 1.6.5Overview of

registration scopeSection 1.6.1

Calculation of the volume to be registered

Section 1.6.2Active substance for use in plant protection products

Section 1.6.5.2

Notified substances (Directive 67/548/EEC)

Section 1.6.5.3

Food or feedingsstuff

Section 1.6.4.1

Active substance for use in biocidesSection 1.6.5.1

Medicinal productsSection 1.6.4.2

Annex V substancesSection 1.6.4.4

Annex IV substancesSection 1.6.4.3

Recycled or recovered substance already registered

Section 1.6.4.5

Re-imported substanceSection 1.6.4.6

PolymerSection 1.6.4.7

Substances exempted from

REACHSection 1.6.3

Radio-active substances

Section 1.6.3.1

Substances under customs supervision

Section 1.6.3.2

WasteSection 1.6.3.4

Substances used in the interest of defence and

covered by National exemptions

Section 1.6.3.3

Non isolated intermediatesSection 1.6.3.5

Transported substancesSection 1.6.3.6 PPORD

Section 1.6.4.8

Calculation of the tonnage in case of exemptions

Section 1.6.2.1

Addition of the volumes Section 1.6.2.2

Calculation of the amount of substance in a preparation or in

articlesSection 1.6.2.3

Calculations of yearly tonnage for phase-in and non phase-in

substancesSection 1.6.2.4

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> 1 ton

Registration

0 1 2 3 4 5 6 7 8 9 10 11

>100 ton

01/06/07 01/12/10 01/06/13 01/06/18

01/06/08

01/12/08

>1000 tonCMR >1 tonN, R50-53 > 100 ton

Pre-registration

Non phase-in substances

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Registration

• Technical dossier

• Chemical safety report• > 10 ton/year

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Evaluation

• Dossier evaluation • Examination of testing proposals

• Agency examines proposal for testing, drafts decision and gives deadline

• Compliance check of registrations (min 5%)

• Information complies with requirements

• Adaptations of standard information requirements comply

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Evaluation

• Substance evaluation• Criteria for substance evaluation

• Agency develops criteria for prioritising substances using a risk-based approach (hazard information, exposure and tonnage).

• Community rolling action plan • Agency

• Inclusion in plan if grounds for considering risk – Structural ressemblance– Aggregated quantities of different suppliers

• Planning covers three year period

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Authorisation

• Substances of very high concern

• Carcinogenic cat 1 and 2

• Mutagenic cat 1 and 2

• Toxic for reproduction cat 1 and 2

• Persistent, bioaccumulative and toxic (PBT)

• Very peristent and very bioaccumulative (vPvB)

• Endocrine disrupting substances, and substances of equivalent concern not fulfilling criteria of PBT and vPvB

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Authorisation

MS or Agency makes Annex XV

dossier

Candidate list

Inclusion in Annex XIV

Application for authorisation

Authorisatie granted or not

Review of authorisations

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Restrictions

• General issues • Safety net

• Takes over existing legislation (Directive 76/769/EEC)

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REACH: new communication

• A producer/importer• Registers a substance• For specific uses • These uses are covered by the chemical safety

assessment (if > 10 ton per year)• If substance is dangerous exposure scenarios (ES) must

be worked out • These ES will be added to the extended safety data sheet

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