REACH
Kees van Leeuwen
Tim Bowmer
Dinant Kroese
TNO Quality of Life
Zeist, The Netherlands

Why are we here today?
! The REACH legislation is complex! Most guidance documents are not yetavailable! We will try to explain it! Because of our intensive involvement in
REACH we realize that there are many
devils in the details.

Presentations and questions on:
A. General introduction on REACH
B. Registration and pre-registration
C. Data requirements & exposure scenarios
D. Chemical safety assessment

REACH
GENERAL INTRODUCTION

Kees van Leeuwen
TNO Quality of LifeZeist, The Netherlands

CONTENTS
1.
2.
3.
4.
5.
6.

History
Key elements of REACH
Basic structure of REACH
Stakeholders in REACH
Timelines for REACH
Guidance and tools

1. HISTORY! Feb 2001

White Paper published! Summer 03

Internet consultation! 29/10/2003

Proposal adopted by Commission! 17/11/2005

Parliament Opinion in First Reading! 26/06/2006

Council Common Position adopted! 13/12/2006

Parliament Opinion in Second Reading! 18/12/2006

Regulation adopted

Importance of the chemical industry! In 2005 world production of chemicals reached "1500 billion! Employment: approximately 12 million people world-wide (OECD1998)! In OECD countries, chemicals and chemical products represent
14% of total imports and exports of manufactured goods.
! According to the OECD chemicals make up as much as 12% ofsome countries# gross domestic product (GDP).$Chart 1.1: Geographic breakdown of world chemicals*sales

2. Key elements of REACH! Single Coherent System for new (non phase-in) and existing(phase-in) substances! Responsibility for all manufacturers and importers! Registration of substances produced/imported above 1 tonne/year! Evaluation by the Agency and Member States! Authorization for substances of very high concern! Restrictions - the safety net! Agency to manage the system

Scope of REACH! REACH has a very wide scope. It applies to all chemicalsubstances which are manufactured, imported, placed on
the market or used within the European Community, either
on their own, in a preparation or in an article.
! Some substances are exempted from the overall scope ofREACH while others are exempted from certain provisions

Core tools under REACH! The Chemical Safety Assessment (CSA) is the tool usedto determine! The Chemical Safety Report (CSR) is the tool used torecord/document! The Safety Data Sheet (SDS) is the tool used tocommunicate

3. Basic structure of REACH! Final version (corrigendum) published in OJ L136,
volume 50, on 29 May 2007
! 141 articles! In 15 Titles! With 17 annexes

OJ = Official Journal of the European Union

Structure of REACH
Title I
Title II
Title III

General issues
Registration of substances
Data sharing and avoidance of unnecessary
testing
Title IV
Information in the supply chain
Title V
Downstream users
Title VI
Evaluation
Title VII Authorization
Title VIII Restrictions on the manufacturing, placing on themarket and use of certain dangerous substancesand preparations

Structure of REACH
Title IX
Title X
Title XI
Title XII
Title XIII
Title XIV
Title XV
Annexes

Fees and charges
AgencyClassification and labelling inventory
Information
Competent authorities
Enforcement
Transitional and final provisions
There are 17 annexes

4. Industry stakeholders in REACH
1.
2.
3.
4.
5.
6.

Manufacturers and importers of substances in quantities < 1 tonne/yManufacturers of substances in quantities of % 1 tonne/yImporters of substances and preparations in quantities of % 1 tonne/y
Producers of articles
Importers of articles
Downstream Users

Appendix 1 of the Guidance on Registration(see Websites of ECB & ECHA) provides detailed guidanceon the different rolesand responsibilities

MEMBER
STATES
INDUSTRY

Stakeholdersof REACH
EUROPEAN
COMMISSIONNGOs

AGENCY(ECHA)5. Timelines for REACH
1 June 2007
Titles I, IV, XII, XIII commence
Agency (Title X) commences in Helsinki, FIN

1 June 2008
Titles II, III, V, VI, IX, XI commence
Begin registration of new substances

1 December 2008
Deadline for pre-registration of all phase-in substances

1 June 2009First recommendation for Annex XIV substances (every 2 y)Title VIII and Annex XVII applies (76/769 repealed)Timelines for REACH
30 November 2010
Registration deadline for substances of 1000 tonnes and more
+R50/53 substances 100 tonnes and more
+CMR substances 1 tonne or more

1 December 2011
First Community Rolling Action Plan

31 May 2013
Registration deadline for substances of 100-999 tonnes

31 May 2018
Registration deadline for substances of 1-99 tonnes

Registration under REACH
Aim: to ensure that industry adequately manages the risk
arising from its substances (starting at 1 tonne/y)Method:& Manufacturer/importer obtains adequate data& Provides a registration dossier which includes a chemical safety reportfor substances above 10 tonnes/y& Submits to authorities (enforcement, transparency)& Increased info requirements according to tonnage (testing proposal)& Reduced requirements for polymers and intermediates

REACH
Main tasks timeline
Pre-registration
Manufacturers
Importers

12

M/I Dossier
Preparation
Registration

34

Dossier
Evaluation
Agency/MS56Freeto market?
Authorisation

Understanding
REACHApril
2007

April ! Oct2008

SIEFs ,Consortia
M/IDec2008

DU

DataCollection

DU

DU
DU

DUSDS
Evaluation

April
2010 ! 2013 - 2018

Registration timelines

Pre-registration> 1000 t/y
CMRs (> 1 t/y)
Very aquatic toxic (R50/53) > 100 t/y)
100 - 1000 t/y

Entry into force
1 June2007

1 - 100 t/y

Non-phase-in substances

1 June2008
1 December
2008

30November
2010

31 May2013

31 May2018

REACH IT Scheme

Authorization under REACH! Deals with CMR (category 1 or 2), PBT, vPvB, and substancesof 'equivalent concern$! Focus on wide dispersive use and high volumes! Prioritized by the Agency with input from the Member States! Considerations:& The risks and adequate control of these risks& Social and economic benefits/implications& The analysis of alternatives submitted& Available information on risks of any alternative substances ortechnologies! Commission decision on authorization based on Agency opinion(Inclusion in Annex XIV)

6. REACH guidance and tools! RIP 1: Process description! RIP 2: Development of REACH-IT! IUCLID-5! Reach Navigator! REACH-IT! RIP 3: Guidance documents for industry! RIP 4: Guidance documents for authorities! RIP 5/6: Setting up the Agency

Comprehensive guidance and tools
Multi-stakeholder process of over 200 experts!
!
!

6 RIP Projects finalised
REACH Navigator Tool is ready
IUCLID 5 is ready

Sources:
http://iuclid.eu
http://ec.europa.eu/echa
http://ecb.jrc.it/reach/Comprehensive guidance and tools
But also:!
!
!

8 RIP Projects still running
1 RIP Project (3.6) still to start
Not all guidance is comprehensive and concise

1.
2.
3.

Implementation will be a long process
A process of 'learning by doing$
Quality and acceptance take time

3.1:
3.1:Preparing
Preparingthe
theregistration
registrationdossier
dossier
3.2:
3.2:Preparing
PreparingthetheCSR
CSR

3.3:
3.3:Information
Information
requirements
requirements

3.4:
3.4:Guidance
Guidanceonondata-sharing
data-sharing

RIP-3: Guidance
for industry

3.5:
3.5:Guidance
Guidanceforfordownstream
downstreamusers
users

3.8:
3.8:Requirements
Requirements
forforarticles
articles! READY! PENDING

3.10:
3.10:Guidance
Guidanceon
onchecking
checking
substance
substanceIDID

3.6:
3.6:Guidance
Guidanceon
on
C&L
C&L
under
underGHS
GHS

3.7:
3.7:Guidance
Guidanceon
onapplications
applicationsfor
forauthorisation
authorisation

3.9:
3.9:Guidance
Guidance
on
onSEA
SEA4.1:
4.1:Guidance
Guidanceonon
dossierdossierevaluation
evaluation

4.3:
4.3:Inclusion
Inclusionof
ofsubstances
substancesin
in
Annex
XIV
Annex XIV

4.4:
4.4:Preparation
PreparationofofAnnex
AnnexXV
XVdossiersdossiers

4.2:
4.2:Guidance
Guidanceon
onsubstance
substanceevaluationevaluation

RIP-4:
Guidance forauthorities
4.5:
4.5:Priority
Prioritysetting
settingfor
forevaluation
evaluation! READY! PENDING

Further information on guidance and tools:
http://ecb.jrc.it/REACH/

http://ec.europa.eu/echa/

European Chemicals Agency (ECHA)
The Agency, located in Helsinki, Finland will manage the registration, evaluation, authorisation and restriction processes for chemical substances to ensure consistency across the European Union. These REACH processes
are designed to provide additional information on chemicals, to ensure their safe use, and to ensure competitiveness of the European industry.
In its decision-making the Agency will take the best available scientific and technical data and socio-economic information into account. It will also provide information on chemicals and technical and scientific advice. By
assessing and approving testing proposals, the Agency will minimize animal testing.
During the first 12 months the Agency is building up its organisation and recruiting personnel to be ready to accept registrations from 1 June 2008.

MoreRelevant websites" Website of the European Chemicals Bureau: http://ecb.jrc.it/reach/" Website of the European Chemicals Agency:
http://ec.europa.eu/echa/home_en.html" Websites of the European Commission
http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm
http://ec.europa.eu/enterprise/reach/index_en.htm" http://ecb.jrc.it/DOCUMENTS/REACH/REACH_in_brief_0207.pdf" Helpdesks of the EU member states, i.e.:
http://www.reachright.ie
http://www.senternovem.nl/reachRelevant references" Haigh N Baillie A. 1992. Final report on chemicals control in the EuropeanCommunity in the 1990s. Institute for European Environmental Policy, London, UK.
" Van Leeuwen CJ, Bro-Rasmussen F, Feijtel TCJ, Arndt R, Bussian BM, Calamari
D, Glynn P, Grandy NJ, Hansen B, Van Hemmen JJ, Hurst P, King N, Koch R,Müller M, Solbé JF, Speijers GAB, Vermeire T. 1996. Risk assessment andmanagement of new and existing chemicals. Environ Toxicol Pharmacol 2: 243-299" Allanou R, Hansen BG, Van Der Bilt Y. 1999. Public availability of data on EU highproduction volume chemicals. Report EUR 18996 EN, European Commission, Joint
Research Centre, Ispra, Italy.

" Commission of the European Communities. 2007. Corrigendum to Regulation (EC) No 1907/2006 of theEuropean Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation,Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency,
amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives
91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006). OJ L136, volume 50, 29May 2007.
" Van der Poel, P, Brooke, D and Van Leeuwen, C.J. 2007. Emissions of chemicals. In: Risk assessment ofchemicals. In: Risk Assessment of Chemicals. An Introduction (2nd edition). Van Leeuwen, C.J. and T. G.
Vermeire, eds. Springer Publishers, Dordrecht, The Netherlands, pp 37-72.
" Van Leeuwen, C.J., B.G. Hansen and J.H.M. de Bruijn. 2007. Management of industrial chemicals in theEuropean Union (REACH). 2007. In: Risk Assessment of Chemicals. An Introduction (2nd edition). Van
Leeuwen, C.J. and T.G. Vermeire, eds. Springer Publishers, Dordrecht, The Netherlands, pp 511-551.
Greim, H. et al. 2006. Toxicological comments to the discussion about REACH. Arch Toxicol 80:121-124