Introducing REACH
The New Chemicals Legislation for Europe
JMoE Symposium on REACH
2 March 2007
Cristina de Avila
DG Environment, European Commission

European Commission - DG Environment

Contents
Why do we need REACH?
Key elements of REACH
Adopting REACH
How does REACH look like?
What next?
Conclusion

1European Commission - DG Environment

Why do we need REACH?
Current chemicals management system is inefficientDifficult to identify risks + difficult to address risks: Lack of information about most chemicals on the market
 Burden of proof lies on public authorities No efficient instrument is in place to deal with problematic
substances

Lack of incentives for innovation
Lack of confidence in chemicals and the chemicals
industry.

European Commission - DG Environment

WHAT is REACH?
Regulation on the Registration, Evaluation and the
Authorisation of CHemicals
Scope:manufacture, import, placing on market and use of substances(on their own, in preparations or in articles)

Goals: Improving health and safety of workers and the generalpublic.
 Environmental protection – avoiding chemical contaminationof air, water, soil and damage to biodiversity
 Maintaining a competitive/innovative chemicals industry

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European Commission - DG Environment

Key elements of REACH
Registration of substances ≥ 1 tonne/yr
Evaluation of some substances
Authorisation only for substances of very highconcern
Restrictions - the safety net (Community wide
action)Agency to efficiently manage system
Focus on priorities:
Substances with high volumes and those of greatest concern!

European Commission - DG Environment

Adopting REACH
Proposal by the Commission: October 2003
Adopted by the European Parliament and the Council
 Fist reading by the European Parliament: November 2005
 Common Position by the Council: June 2006
 Final agreement reached: November 2006
 Parliament adopts agreement (+529/-98/o24): 13 December Council adopts agreement (by unanimity): 18 December

REACH Regulation published in the OJ: 30 December
Entry into force: 1 June 20073

After adoption…
How does REACH look like?

European Commission - DG Environment

REACH – Key elements
 Registration of substances ≥ 1 tonne/yr Increased information and communication throughout the
supply chain Evaluation of some substances Authorisation only for substances of very high concern
 Restrictions - the safety net (Community wide action)
 Agency to efficiently manage system
Focus on priorities:
Substances with high volumes and those of greatest concern!

4European Commission - DG Environment

Registration
AIM: Ensure industry adequately manages risks from substances What?
Tonnage based
Registration deadlines: 3½-6-11 years
Limited information for intermediates and exemption for polymers
Limited information for research and development (PPORD)
Substances in Articles.
 How?
Manufacturer/importer obtains or generates adequate information
Electronic dossier submitted to Agency
Certain non-confidential information to central (largely public)
database.

European Commission - DG Environment

Registration Requirements (1)Elements of a registration dossier: 1 tonne and above: Intrinsic properties 10 tonnes and above: Chemical Safety Report (CSR)

Tiered testing: 1-10 tonnes: Available information + Phys-chem properties
in Annex VII (full Annex VII for prioritised substances) 10-100 tonnes: Annexes VII and VIII.
 100-1000 tonnes: Annexes VII and VIII; testing proposals
for information in Annex IX ≥ 1000 tonnes: Annexes VII and VIII; testing proposals for
information in Annex IX and X

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European Commission - DG Environment

Registration Requirements (2)HealthEnvironment

 In vitro skin and eye irritation
 Skin sensitiation
 In vitro mutagenicity
 Acute toxicity (one route) Acute aquatic toxicity – Daphnia Biodegradation – biodegradability andhydrolysis
 Acute aquatic toxicity – Algae

10100t In vivo skin and eye irritation
 Further in vitro mutagenicity
 Sub acute toxicity (28 days)
 Reproductive toxicity screen Acute aquatic toxicity – Fish
 Activated sludge Adsorption/desorption screening

1001000t

 Further mutagenicity tests
 Sub-chronic toxicity (90-days)
 Further reproductive toxicity tests

 Long term aquatic toxicity daphnia and fish Further degradation and fate/behaviour studies
 Short term effects on terrestrial organisms>1000t Further mutagenicity tests
 Carcinogenicity
 Chronic toxicity
 Further reproductive toxicity tests

 Further degradation and fate/behaviour studies
 Long term effects on terrestrial organisms

1-10t
prioritised

European Commission - DG Environment

Registration – OSOR
Joint information

Hazard information and testing
proposals
Classification and labelling

Individual information

Company specific information
Information to keep confidential

ChoiceCSR
Guidance on safe use
Quality assessed Joint data submission: mandatory with opt outs:
 Disproportionate cost
 Commercial secrets
 Disagreement on selecting data

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European Commission - DG Environment

Registration: Animal Testing Data-sharing obligation avoids many tests
 New testing is only the last resort: Existing information is acceptable (if quality ok) Read across, (Q)SARs, in vitro tests acceptable if validated
 Some information requirements may be waived:Because testing cannot be done on a substance
For some tests in some volume bands because of no/limited
exposure

European Commission - DG Environment

Registration – Substances in Articles
Registration of substances intentionally released
 Substance present above 1 tonne Agency may require registration for substances which are notintentionally released from an article but present a risk.

Notification of substances of very high concern if
 SVHC present above 1 tonne
 SVHC present above a concentration limit of 0,1%
 Exposure of the public or the environment during the full life
cycle cannot be excluded
 Applies 6 months after substance is listed on authorisation
candidate list.

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European Commission - DG Environment

Registration Timeline
Notification of SVHC in SIA
Pre-registration

Agency start up•1000+ tonnes•CMRs 1+ tonne• PBTs/vPvBs (R50-53)
100+ tonnes

100-1000 tonnes

1-100 tonnes

Non-phase-in substances
1 June 08
EIF
1 Dec 08
1 June 07

1 June 11

1 June 13

1 June 18

1 Dec 10European Commission - DG Environment

Availability of Information
 Published on web, free of charge:
 Information on substance identity,
 classification,
 physicochemical data, results of toxicological and ecotoxicological studies, DNELs, PNECs,
 guidance on safe use,
 analytical methods.

 Published on web, free of charge, unless companies justify
otherwise: Information on tonnage bands,
 impurities, information in the SDS (unless above), study summaries/robust study summaries,
 IUPAC name / trade name (for new dangerous substances up to 6 years).

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European Commission - DG Environment

Downstream Users (DU)
Manufacturer/importer CSR to cover all uses identified
by downstream users.
DU benefit from choice of: supplier carrying out assessment, or for confidentiality reasons doing own assessment.

If using suppliers CSR just have to: implement supplier’s RRM for identified uses

If carrying own CSR will have to: perform assessments only for ‘unidentified uses’ (using
supplier hazard information)
 inform Agency of ‘unidentified uses’

European Commission - DG Environment

Information through the supply chain
What?
 Expanded SDSs – info from Chemical Safety Reports
 Exposure scenarios as Annex
 Information on authorisations, restrictions, registration
number, info for risk management, etc.
 Information on SIA (>0.1%w/w)
 Information up the supply chain on new hazards and if
received info is challenged.

Result?
 more information on risks
 downstream users brought into the system dialogue up/down the supply chain encouraged/stimulated
Encourage communication  Improve risk management

9European Commission - DG Environment

Evaluation
Provide confidence that industry is meeting obligations
Prevent unnecessary testing

Dossier evaluation: Agency

Check test proposals

Compliance

Substance evaluation:
Agency (MS)Examine any information ona substance on CRP

Output:• Further information decisions• Info to other parts of REACH/other legislation

European Commission - DG Environment

Authorisation
Ensure risks from substances of very high concern
are properly controlled and eventually substituted.

Substances of very high concern: Carcinogenic, mutagenic, reprotoxic (CMR) Persistent, bioaccumulative and toxic (PBT) Very persistent and very bioaccumulative (vPvB)
 Substances of “equivalent concern for which there isscientific evidence of probable serious effects”

10European Commission - DG Environment

Authorisation - Overview

Candidate list

Agencyprioritisation

Applicant applies toAgencyCommission
proposal for
granting or
refusing
authorisation(with analysis ofalternatives/ substitution
plan)

Substances on
Annex XIV

Authorisation
granted/refused

European Commission - DG Environment

Authorisation Chart
SUBSTANCES OF VERY HIGH CONCERNCMR CAT.1&2, PBT, vPvB

Can an effect threshold beestablished?

PBT or vPvB or substance of equivalentconcern to PBT or vPvBNo

Do social and economic
advantages outweigh the risks
to human health and theNoenvironment?

Yes

Are the risks ‘adequately
controlled’? (i.e. exposure<threshold)

No

Yes

Are suitable alternative
substances or technologies
available?

Yes

AUTHORISATION GRANTEDYesAUTHORISATION
REFUSED

CMR or substance of equivalentconcern to CMR+ substances ‘for which there isscientific evidence of probableserious effects to humans or theenvironment which give rise to an
equivalent level of concern’No

11European Commission - DG Environment

Restrictions
AIM: act as safety net

Community wide concern
MS/COM initiated Fast track possible e.g. CMR substances for consumers.

Agency Committees examine: The risk, and The socio-economic aspects involved.

Commission - final decision through comitology
Carry-over of existing restrictions (76/769/EEC).

European Commission - DG Environment

European Chemicals Agency
Day to day management of REACH
 Technical, scientific and administrative aspects

Responsibilities:
 Registration - reject or require completion of registration
 Evaluation - carry out dossier evaluation, responsible for substanceevaluation, ensure a harmonised approach; take decisions
 Authorisation/restrictions - facilitate process; suggest priorities
 Secretariat for Forum and Committees
 Deal with appeals - registration, R&D, evaluation, confidentiality.

12European Commission - DG Environment

What next?

European Commission - DG Environment

REACH Implementation
End 2006 – Publication in the OJ
June 2007 – Entry into force of REACH– Setting up the Agency in Helsinki
June 2008 – Agency operational
June 2009 – First substances prioritised for authorisation
June 2010 – ‘New’ restrictions
End 2010 – First registration deadline for ≥1000t &CMR
End 2018 – Last registration deadline for ≥ 1t

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European Commission - DG Environment

The Interim Strategy
4 basic work elements:- Re-focus Current Activities- Preparing for REACH- Strategic Partnerships- Setting up the Agency

Aligning Dir. 67/548 and Reg.
793/93 with REACH
Developing Guidance Documents
and Software Tools for efficient,transparent and consistent
implementation“Working together, preparing for
REACH”

Finland: Practical aspects
COM: Organisation

The Interim Strategy prepares ALL stakeholders
for a Sustainable REACH Implementation

European Commission - DG Environment

The RIPs
REACH Implementation Projects (RIPs): RIP 1: Process descriptions (available on ENV website) RIP 2: Development of IT systems (REACH-IT)
 RIP 3/4: Guidance Documents (industry/authorities)
 RIP 5/6: Preparation for start-up of Agency
 RIP 7: Commission preparations.

14European Commission - DG Environment

Guidance for Industry & Authorities
 RIP 3/4:
 Preparing a Chemical Safety Report * Information Requirements * Data-sharing (Pre-registration)
 Downstream user Requirements*
 Carrying out a Socio-Economic Analysis*
 Preparing an Application Dossier for Authorisation
 C&L under GHS
 Preparing the Technical Dossier for Registration
 Priority Setting for Evaluation
 Dossier Evaluation
 Substance Evaluation
 Inclusion of Substances into the list of substances subject toAuthorisation.

* Definitive document

European Commission - DG Environment

Stakeholder Expert Groups
Discuss the project implementation, including
work plan, deliverables and timing
Discuss progress and advise on consequentadjustments needed to the work plan
Provide comments on draft guidance documents
Where relevant, and a mandate has been given by
the Commission, carry out parts of the RIP work.

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European Commission - DG Environment

SEG Representation
Approximately 200 experts follow the process!
19 MS or accession countries
Industry organisations: CEFIC, CEPE, CEPI, CONCAWE, DUCC, ESIA, Euratex, Reach
Alliance, EuPC, BLIC, EDANA, Eurocommerce, AISE, ASD,
FECC, UNICE, ESBA, CIA, EPIA.

NGO’s: ETUC, FoE, WWF, ECEAE, EEB, Greenpeace.

Others:
 OECD secretariat, Health Canada, Japan Business Council in
Europe.

European Commission - DG Environment

Example: Exposure Scenarios RIP 3.2
Exposure Scenarios represent a new element of“risk assessment” and is central to REACH
implementation;
Industry, in particular sector / branchorganisations should provide support by gathering
best practice Risk Management Measures anddeveloping generic but sector-specific Exposure
Scenarios

16European Commission - DG Environment

The ‘Arona network’: Main conclusions
A manageable number of ES is needed to coverstandard processes within an industrial sector
Bottom-up approach is a way forward indeveloping ES
Use standard descriptions of current practicewithin industrial sectors as a starting point
Report and presentations at:
http://ecb.jrc.it/REACH→ documents →Arona network

European Commission - DG Environment

Preparation for non-EU
manufacturers
No obligations under REACH
Obligations lie on the importers
Non-EU manufacturers could choose to have an
only representative17

European Commission - DG Environment

Preparation for non-EU
manufacturers: importers
Make an inventory of substances to be exported
Study obligations of your EU importer
 REACH registration requirements
 Guidance developed: http://ecb.jrc.it/REACH/

Actively communicate with your EU clients to see
how their needs can be met and Provide adequate information on the substances Develop and provide exposure scenarios

Plan for the future Don’t leave data generation and assessment too late

European Commission - DG Environment

Preparation for non-EU
manufacturers: ‘only’ representative
What are your uses and what are the identified
uses?
How can these best be expressed in (broad)
exposure scenarios?
 M/I: Specific scenarios cost more to prepare but may require lesstesting and less demanding risk management measures – attractive
to DU
 As a DU, do you wish to identify your use?

M/I and DU - start talking to each other today!
Use the flexibility in the Regulation
 ES can be as broad as possible but need to be specific where
necessary to communicate appropriate risk management measures18European Commission - DG Environment

Conclusion
REACH will be in force in a few months
REACH will have benefits
REACH opportunity to rebuild confidence inchemicalsStart preparing now.

European Commission - DG Environment

http://europa.eu.int/comm/environment/chemicals/index.htm
http://europa.eu.int/comm/enterprise/chemicals/index.htm

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