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REACH: state of art and base definitions
Dr. Erwin Annys
Sr. Advisor
Product & Innovation Policy
WERCS 2007 EU User group
Napoli 31/05/07
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WERCS EU User group 2007 – Erwin Annys
REACH
Registration Evaluation Authorisation and restriction
of Chemical substances
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WERCS EU User group 2007 – Erwin Annys
Substance – preparation - article
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WERCS EU User group 2007 – Erwin Annys
REACH
Registration
Evaluation
Authorisation
Restriction
Classificationindex
Sharing data
Info insupply chain
Down streamuse
Responsibility industry
Agency
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WERCS EU User group 2007 – Erwin Annys
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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WERCS EU User group 2007 – Erwin Annys
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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WERCS EU User group 2007 – Erwin Annys
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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WERCS EU User group 2007 – Erwin Annys
> 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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WERCS EU User group 2007 – Erwin Annys
Registration
Technical dossier Chemical safety report
> 10 ton/year
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WERCS EU User group 2007 – Erwin Annys
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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WERCS EU User group 2007 – Erwin Annys
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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WERCS EU User group 2007 – Erwin Annys
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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AuthorisationMS 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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WERCS EU User group 2007 – Erwin Annys
Restrictions
General issues Safety net Takes over existing legislation
(Directive 76/769/EEC)
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WERCS EU User group 2007 – Erwin Annys
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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WERCS EU User group 2007 – Erwin Annys