reach: data sharing and sief (rip 3.4) wercs 2007 us user group albany 27/06/2007 dr. erwin annys...
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REACH: data sharing and SIEF (RIP 3.4)WERCS 2007 US User group Albany
27/06/2007
Dr. Erwin Annys Sr. Advisor Product & Innovation Policy
Event –Erwin Annys
Pre-registration
• REACH makes a distiction between • New substances (brought on the European market after 1981)
• Substances on the European market before 1981
• Phase-in substances
Event –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
Event –Erwin Annys
Pre-registration
• Pre-registration is CRUCIAL if you wants to use the mentioned delays for registration
• What to pre-register? Everything you have to register!
Event –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
Event –Erwin Annys
Pre-registration
• Only for phase-in substances• EINECS
• Manufactured but not brought on the market the last 15 years before the entry into force
• No-longer polymers
Event –Erwin Annys
Pre-registration
• Between 12 and 18 months after the entry into force of REACH • Name of the substance and EINECS and CAS number• Name and address contact person• Envisaged deadline for the registration and the tonnage band• Name of substance(s) and EINECS and CAS number(s) for which the available
information is relevant for (Q)SAR or grouping or read-across
Event –Erwin Annys
Pre-registration
• Agency: 1 month after the deadline, publication on the website of • Name of the substances
• CAS and EINECS number
• Agency: non publicly available list of those that pre-registered the same substance
Event –Erwin Annys
SIEF and consortia
• Pre-registration brings you into• Substance Information Exchange Forum (SIEF)
• SIEF has two objectives• Facilitate the exchange of information hence avoiding duplication of the
studies
• Agree on classification and labelling
Event –Erwin Annys
SIEF and consortia
• Testing on vertebrate animals• Shall share information
• Other testing• May share information
Event –Erwin Annys
SIEF and consortia
• From 12 untill 18 months pre-registration• After 19 months list(s) agency • SIEF member
• Ask for tests on vertebrate animals available within SIEF
• Within one month• Proof of cost
• Determined in a fair, transparant and non-discriminatory way
Event –Erwin Annys
SIEF and consortia
• SIEF• Sharing of data
• Consortia• Not mentioned in REACH text
• But the sharing of data will make this necessary
• Experience with High Production Volume (HPV) programm, but this was voluntary
Event –Erwin Annys
Pre- Registration Pre- SIEF SIEF
Identifysimilar
Substances
Pre-Registrationdossiers
Pre-Registr.
data
Industry
Agency‘Contacts’List
AllocatePre-SIEF Facilitator
SubstanceId. Analysis
SIEF
SIEF Formation
Data Exchange
Study
Event –Erwin Annys
Pre- Registration Pre- SIEF SIEF
Identifysimilar
Substances
Pre-Registrationdossiers
Pre-Registr.
data
Industry
Agency‘Contacts’List
AllocatePre-SIEF Facilitator
SubstanceId. Analysis
SIEF
SIEF Formation
Data Exchange
Study
• Identifier = EINECS # (encourage to use 3.10 guidance)
Event –Erwin Annys
Pre- Registration Pre- SIEF SIEF
Identifysimilar
Substances
Pre-Registrationdossiers
Pre-Registr.
data
Industry
Agency‘Contacts’List
AllocatePre-SIEF Facilitator
SubstanceId. Analysis
SIEF
SIEF Formation
Data Exchange
Study
• Identifier = EINECS # (encourage to use 3.10 guidance)
• Pre-SIEF• Updates will be done continuously• Companies will be notified:
• by e-mail• by query
Event –Erwin Annys
Pre- Registration Pre- SIEF SIEF
Identifysimilar
Substances
Pre-Registrationdossiers
Pre-Registr.
data
Industry
Agency‘Contacts’List
AllocatePre-SIEF Facilitator
SubstanceId. Analysis
SIEF
SIEF Formation
Data Exchange
Study
• Identifier = EINECS # (encourage to use 3.10 guidance)
• Pre-SIEF• Updates will be done continuously• Companies will be notified:
• by e-mail• by query
Pre-SIEF:• Pre-SIEF facilitator is first notifier (by default)• Facilitator role can be passed on to someone else• Facilitator expectations:
• Manage Pre-SIEF agreement• Distribute 3.10 guidance template• Assign to SIEF based on 3.10 Id.• Communicate • Allocate SIEF facilitator