REACH: state of art and base definitions

Dr. Erwin Annys

Sr. Advisor

Product & Innovation Policy

WERCS 2007 EU User group

Napoli 31/05/07

2

WERCS EU User group 2007 – Erwin Annys

REACH

Registration Evaluation Authorisation and restriction

of Chemical substances

3

WERCS EU User group 2007 – Erwin Annys

Substance – preparation - article

4

WERCS EU User group 2007 – Erwin Annys

REACH

Registration

Evaluation

Authorisation

Restriction

Classificationindex

Sharing data

Info insupply chain

Down streamuse

Responsibility industry

Agency

5

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

6

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

7

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

8

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

9

WERCS EU User group 2007 – Erwin Annys

Registration

Technical dossier Chemical safety report

> 10 ton/year

10

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

11

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

12

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

13

WERCS EU User group 2007 – Erwin Annys

AuthorisationMS or Agency

makes Annex XV dossier

Candidate list

Inclusion in Annex XIV

Application for authorisation

Authorisatie granted or not

Review of authorisations

14

WERCS EU User group 2007 – Erwin Annys

Restrictions

General issues Safety net Takes over existing legislation

(Directive 76/769/EEC)

15

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

16

WERCS EU User group 2007 – Erwin Annys