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

Event –Erwin Annys