1. 22/02/2019
REACH
REACH update

2. The Current EU Chemicals Policy
22/02/2019
The Current EU Chemicals Policy
Problems
Existing substances can be used without testing
lack of knowledge about their properties and uses
Burden of proof on public authorities
Current system slow to act
no efficient instrument to deal with problematic substances
Lack of incentives for innovation
in particular for less hazardous substitutes
EU review of Directives revealed a number :
Existing substances can be used without testing
lack of knowledge about their properties and uses
Burden of proof on public authorities
Current system slow to act
no efficient instrument to deal with problematic substances
Lack of incentives for innovation
in particular for less hazardous substitutes
Burden of the Past

3. REACH One System A Tiered Approach
22/02/2019
REACH
One System
Single, coherent system for new/existing chemicals
Elements:
Registration of substances above 1 tonne
Evaluation by the Member States
Authorisation for substances of very high concern
Restrictions - the safety net
Agency to manage system
Focus on:
high volumes
greatest concern.
Single, coherent system for new/existing chemicals
Elements:
Registration of substances above 1 tonne
Evaluation by the Member States
Authorisation for substances of very high concern
Restrictions - the safety net
Agency to manage system
Focus on:
high volumes
greatest concern.
A Tiered Approach

4. Development of the new legislation: REACH
22/02/2019
Development of the new legislation: REACH
White Paper (Feb 2001)
Reactions: Council (Jun 2001) and Parliament (Oct 2001)
Reactions: stakeholders
Fact-finding (Sep Mar 2002):
Technical consultation (Working Groups), Studies
Drafting stage (Mar May 2003)
Internet Consultation (15 May 2003 to 10 July 2003)
6000 consultation responses
White Paper published Feb 2001
Reactions from Council (Jun 2001) and Parliament (Oct 2001) generally supportive of aims
Reactions from stakeholders - very varied
Extremely high interest in proposals extending beyond EU
Responsibility shared between DGs ENV and ENTR
Fact-finding stage (Sep Mar 2002):
Technical consultation with stakeholders (Working Groups) - attended also by services
Studies
Business impact assessment
Central Entity feasibility study
Occupational health impact study
Drafting stage (Mar Mar 2003):
Text developed as Building Blocks
JRC contributed significant technical and scientific support
Agreement stage:
All issues resolved within ENTR and ENV by Mar 2003
First inter-service consultation April 2003
7 May Commission discussion & Press Release
15 May Launch of internet consultation
Internet Consultation
Why ?
Reality check at an early stage
Workability - optimal design
Technical and scientific soundness
Involvement of all stakeholders
Commission commitment:Better Governance

5. Internet Consultation (1) Total replies
22/02/2019
Internet Consultation (1) Total replies

6. Internet Consultation (2) Replies by MS
22/02/2019
Internet Consultation (2) Replies by MS

7. Internet Consultation (3) Type of stakeholder
22/02/2019
Internet Consultation (3) Type of stakeholder

8. Internet Consultation (4) Where in the world?
22/02/2019
Internet Consultation (4) Where in the world?

9. Internet Consultation (5) Main issues raised
22/02/2019
Internet Consultation (5) Main issues raised
Issues:
Scope of the system - polymers, intermediates, articles.
Legal certainty - Duty of care.
Costs
Bureaucracy/Powers of the Agency vs MS.
Confidentiality/right to know
Substitution
Animal testing
Issues:
Scope of the system - polymers, intermediates, articles.
Legal certainty - Duty of care.
Costs
Bureaucracy/Powers of the Agency vs MS.
Confidentiality/right to know
Substitution
Animal testing
Conclusion
Cut costs and bureaucracy, particularly for DU and SME, without lowering protection of health and environment

10. Development of the new legislation: REACH
22/02/2019
Development of the new legislation: REACH
White Paper (Feb 2001)
Reactions: Council (Jun 2001) and Parliament (Oct 2001)
Reactions: stakeholders
Fact-finding (Sep Mar 2002):
Technical consultation (Working Groups), Studies
Drafting stage (Mar May 2003)
Internet Consultation (15 May 2003 to 10 July 2003)
6000 consultation responses
Review of replies & re-drafting (Jul - Aug 2003)
2nd inter-service consultation (Sept - Oct 2003)
Adoption of proposals by Commission and start of co-decision procedure (29 Oct 2003)
Decision making in EP and Council: ?
REACH in force: 2006?
White Paper published Feb 2001
Reactions from Council (Jun 2001) and Parliament (Oct 2001) generally supportive of aims
Reactions from stakeholders - very varied
Extremely high interest in proposals extending beyond EU
Responsibility shared between DGs ENV and ENTR
Fact-finding stage (Sep Mar 2002):
Technical consultation with stakeholders (Working Groups) - attended also by services
Studies
Business impact assessment
Central Entity feasibility study
Occupational health impact study
Drafting stage (Mar Mar 2003):
Text developed as Building Blocks
JRC contributed significant technical and scientific support
Agreement stage:
All issues resolved within ENTR and ENV by Mar 2003
First inter-service consultation April 2003
7 May Commission discussion & Press Release
15 May Launch of internet consultation
Internet Consultation
Why ?
Reality check at an early stage
Workability - optimal design
Technical and scientific soundness
Involvement of all stakeholders
Commission commitment:Better Governance

11. Duty of Care Duty of care removed; Replaced by principle:
manufacturers, importers and downstream users to … manufacture, place on the market, import or use .. do not adversely affect human health or the environment.
provisions underpinned by the precautionary principle.

12. DU‘S rights and duties CSA: choice for downstream users
22/02/2019
DU‘S rights and duties
CSA: choice for downstream users
Right to make a use known to his supplier
supplier performs the assessment
Choice to keep his use confidential:
duty to perform CSA if use is not covered in supplied SDS.
Duty to report information if (>=1 tonne)
his use is not covered in the SDS supplied
he applies or recommends different RMM

13. Registration Polymers: Intermediates: 1 to 10 tonnes:
22/02/2019
Registration
Polymers:
no registration but authorisation/restrictions
review on basis of sound technical + valid scientific criteria
Intermediates:
isolated transported: no limitation to 2 sites
1 to 10 tonnes:
reduced testing requirements
no CSA/CSR

14. CSR > 10 tonnes; For identified uses;
Hazard assessment; PBT/vPvB assessment; exposure assessment;
exposure scenarios developed;
Show RMM adequately control risk;
Communicated by SDS

15. Registration – role of Agency
Agency solely responsible for registration:
Preregistration and data sharing
R&D exemptions
Handling of all registrations
Rejections of incomplete registrations
Decisions on confidentiality
Agency will have a board of appeal

16. Evaluation Dossier evaluation Substance evaluation
Examination of testing proposals
Compliance check
CA = where registrant based.
Substance evaluation
Follow-up to suspicion of risk: request further info
MS rolling plans to decide on CA

17. Authorisation AIM Prioritisation For not adequately controlled risks
22/02/2019
Authorisation
AIM
: …to ensure that the risks from substances of very high concern are properly controlled or replaced by suitable alternative substances or technologies
Prioritisation
PBTs, vPvBs, wide dispersive use, high volumes
For not adequately controlled risks
Normally time limited
Assessment of alternative substances or technologies
Substitution plans may be submitted

18. In granting authorisations, the Commission shall not consider:
22/02/2019
Authorisation and WFD
In granting authorisations, the Commission shall not consider:
risks to and via the aquatic environment of discharges of a substance in Directive 2000/60/EC.
Review:
If the environmental objectives of Directive 2000/60/EC are not met:
review of authorisations granted for the use of the substance in the relevant river basin.
The authorisation application and decision shall not address risks to human health and/or the environment of emissions of the substance from an installation for which a permit was granted in accordance with the IPPC Directive (Directive 96/61/EC) or from a point source governed by requirement for prior regulation under the Water Framework Directive (Directive 2000/60/EC) or arising from the use in a medical device as these emissions are adequately controlled under other Community instruments which are applied by the Member States. Therefore, this is necessary not to interfere with such other competences and to avoid differences between the decisions taken under different regulatory regimes as well as the resources in examining an impact twice
Authorisation decisions may need to be amended or withdrawn as a result of a review which can be done at any time when there is a change of circumstances. Such a change of circumstances can for example be changes in the scientific basis for an authorisation decision or that environmental quality objectives as defined under the IPPC Directive or Water Framework Directive are not met because of diffuse emissions to water or the air. Emissions from point sources however are dealt with under those Directives.

19. Substances in Articles
22/02/2019
Substances in Articles
Registration: only if substance is intended to be released
Notification:
producer knows or is made known that substance is released and
quantity released may adversely affect human health or environment
Both: only substances classified as dangerous and in quantities of 1 tonne or more
Agency: may require notified substances to be registered

20. Agency Registration Evaluation Substances in articles Board of appeal
22/02/2019
Agency
Registration
Evaluation
Ensuring a harmonised approach: monitor decisions and develop criteria and priorities
Substances in articles
Require registration
Board of appeal
Decisions on registration, R&D, confidentiality

21. Confidentiality Text defines some types of information
22/02/2019
Confidentiality
Text defines some types of information
to be always kept confidential except in case of an immediate risk;
to be always non-confidential;
Other information may be claimed to be confidential
All non-confidential information will be made available
defined information on the database
other information on request