reach: state of art and base definitions wercs 2007 us user group albany 27/06/2007 dr. erwin annys...
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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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