1. Introduction to The New EU Chemicals Policy REACH
11/13/2018
Introduction to The New EU Chemicals Policy REACH
Framing a Future Chemicals Policy
Boston
27 April 2005
Eva Sandberg
DG Environment, European Commission
P:\

2. What is REACH? A Tiered Approach
11/13/2018
What is REACH?
HIGH level of health and environmental protection with the goal of achieving sustainable development.
Single coherent system for new (non phase-in) and existing (phase–in) chemicals
Elements:
Registration of substances ≥ 1 tonne/yr (staggered deadlines)
More information and communication through the supply chain
Evaluation of some substances by Member States
Authorisation only for substances of very high concern
Restrictions - the safety net
Agency to manage system
Focus on priorities:
high volumes (early deadline)
greatest concern (CMRs early)
A Tiered Approach
P:\

3. Scope
REACH covers
Manufacture, import, placing on market and use of substances
Substances “on their own”, in preparations or in articles

4. European Chemicals Agency
11/13/2018
European Chemicals Agency
Day to day management of REACH
Technical, scientific and administrative aspects
Responsibilities:
Registration - reject or require completion of registration
Evaluation - ensure a harmonised approach; take decisions.
Substances in articles - require registration
Authorisation/restrictions - facilitate process; suggest priorities.
Secretariat for Forum and Committees
Deal with appeals - registration, R&D, evaluation, confidentiality
P:\

5. Registration: general
11/13/2018
Registration: general
AIM: Ensure industry adequately manages the risk from its substances
Method:
manufacturer/importer obtains adequate information;
> 10 tonnes/year: performs chemicals safety reports (inc RRM)
electronic submission to Agency (completeness check)
certain non-confidential information in central, largely public, database.
Scope
substances produced/imported  1 tonne/year
intermediates - reduced requirements.
exemptions - other law, Annex II/III; polymers (review); PPORD
deemed as Registered - biocides, pesticides, notified substances (67/548)
Consortia encouraged
No formal acceptance. No registration: no manufacture or import
P:\

6. Registration: information
11/13/2018
Registration: information
Information requirements - smart/targeted:
exposure often taken into account.
new testing as a last resort – existing data, (Q)SAR, read across.
Low volume chemicals (1-10 tonnes/year):
mostly in-vitro.
Higher volume chemicals:
testing only if existing information/validated alternative methods not sufficient.
Testing programmes - agreed by the competent authorities
REACH = large-scale information collection ≠ large-scale testing.
P:\

7. Registration: Deadlines
11/13/2018
Registration: Deadlines
SIA t t
>1000 t + CMR t
Yr 0
Yr 0 +3
Yr 0 + 6 Yr
2017 +
P:\

8. Generation of Information
11/13/2018
Generation of Information
Annex IX = F L E X I B I L I T Y
(Q)SARs
Use of category approaches
Analogs, read across
Available data (non-EU, GLP, non-GLP)
Exposure based waiving (Annexes VII and VIII)
Historical human data
Data sharing (existing and new)
Testing (in vitro, in vivo) as a last resort
P:\

9. Chemicals Safety Assessment
11/13/2018
Chemicals Safety Assessment
To be performed for all substances (per substance or per group of substances) subject to registration if above 10 tonnes/ per year Per substance or per group of substances
To be documented in a Chemical Safety Report
Part of the registration dossier
Exemptions for substances in preparations below certain concentration limits
Defined in Annex I
Includes
Human health hazard assessment
Environmental hazard assessment
PBT and vPvB assessment
P:\

10. 11/13/2018
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’ ≥ 1 tonne
P:\

11. Substances in Articles
11/13/2018
Substances in Articles
Meet the criteria for classification as dangerous
> 1 t/yr per article type per M/I
Not registered further up the supply chain
11 years and
3 months after entry into force
(2017+)
Known to be released and
Quantity released may adversely affect human health or the environment
Intended to be released
Duties apply to both EU and non-EU producers of articles
Art. 6 has to be seen in context: lesser requirements than for manufacturers of substances
Applies only 11 years +3 months after the entry into force
General obligation to register
Obligation to notify the Agency
Agency may require registration
P:\

12. Avoidance of unnecessary animal testing + save costs
11/13/2018
Data sharing
Avoidance of unnecessary animal testing + save costs
Information > 10 years – freely available
Non-phase-in substances (= new):
Already registered?
Agency enables contact - 50% cost sharing
Studies involving vertebrate animals not repeated
Phase-in substances (= existing):
Potential registrants of same substance: ‘SIEF’
Sharing mandatory (vertebrate animals), if participant refuses to share = sanctions
Equal sharing of costs
P:\

13. Consortia Individual Choice « One for all »
Guidance on safe use
Chemical Safety Report
Summaries or robust study summaries of information derived from application of Annexes V bis IX
Proposals for testing where required by application of Annexes V bis IX
Classification and labelling
Identity of M/I
Identity of the substance
Information on manufacture and use
Statement whether information has been generated by testing on vertebrate animals

14. Information through the supply chain
11/13/2018
Information through the supply chain
What?
Expanded SDSs – info from Chemical Safety Reports
Exposure scenarios as Annex
Information on authorisations, restrictions, registration number etc.
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
P:\

15. Evaluation Provide confidence that industry is meeting obligations
11/13/2018
Evaluation
Provide confidence that industry is meeting obligations
Prevent unnecessary testing
Dossier evaluation
Substance evaluation
Examine any information on a substance
Check test proposals
Compliance
Output:
Further information decisions
Info to other parts of REACH/other legislation
P:\

16. Authorisation
AIM: Ensure risks from Substances of Very High Concern (SVHC) are properly controlled or that they are substituted.
SVHC (CMR, PBT, vPvB, ‘serious and irreversible effects’)
Prioritised (progressively authorised as resources allow)
each substance given individual deadline and use allowed until decision taken.
Applicant to show:
adequate control of risks
if risks not all under control, evidence that social and economic benefits outweigh the risks
Socio-economic authorisation - normally time-limited
substitution plan considered
DU can use suppliers authorisation
Other M/I may get a letter of access to an authorisation

17. Authorisations are Risk based!
Granting
Commission shall grant an authorisation if the risks are adequately controlled as documented in the Chemical Safety Report
If not, it may be granted if the socio-economic benefits outweigh the risk and if there are no suitable alternative substances or technologies
Authorisations are Risk based!

18. Restrictions Community wide concern MS/COM initiated
11/13/2018
Restrictions
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)
POPs
P:\

19. C and L Current legislation: REACH: Inventory
11/13/2018
C and L
Current legislation:
C&L all substances placed on market;
some substances harmonised in Annex I of 67/548
REACH: Inventory
managed by Agency
contains C and L info for all marketed substances:
no tonnage limit
deadlines – 3 years
supplied through registration or separately
Industry co-operate to resolve differences in C&L
EU harmonisation:
CMRs
respiratory sensitisers
P:\

20. C and L: GHS GHS not included in current proposal
11/13/2018
C and L: GHS
GHS not included in current proposal
Studies on differences and impact on down-stream legislation carried out
Implementation foreseen next phase
Proposal for a regulation either part of REACH or separate
Will replace Directives 67/548 and 99/45
Inventory:
managed by Agency
contains C and L info for all marketed substances:
no tonnage limit
Deadlines – phase in deadlines
industry co-operate to resolve differences in C&L
EU harmonisation:
CMRs
respiratory sensitisers
GHS – next phase
P:\

21. Progress in decision-making
11/13/2018
Progress in decision-making
Nov 2003: Proposal submitted to Parliament and Council
Decision making in EP and Council:
Political agreement between MS: end 2005?
Parliament 1st reading: October 2005?
REACH in force: 2007?
P:\

22. Key issues Prioritisation (Registration)
Right balance
Short/long term impacts
1-10 tonnes: Testing requirements
OSOR
Mandatory sharing of all data
Workability of agreement
Authorisation/substitution
Agency
Stronger role in evaluation
Substances in Articles
Balance between protection, workability and WTO concerns

23. Benefits (1): Economic and Strategic
11/13/2018
Benefits (1): Economic and Strategic
Simplification
Level playing-field for new and existing substances
Improved innovation (encourage substitution, not forced)
higher demand for safer substances
higher registration thresholds (as compared to new substances)
more R&D flexibility
Better information through REACH will give enhanced implementation of current law e.g.
Occupational Health Safety law
Integrated Pollution and Prevention Control
Water Framework Directive
Waste legislation
P:\

24. Benefits (2): Health benefits
Illustrative Scenario (COM IA, 2003) respiratory and bladder cancers, skin and respiratory disorders
Health benefits of € 50 billion (order of magnitude)
UK Regulatory Impact Assessment
18 and 37 cancer death reduced per year →positive cost-benefit ratio of the regulation
EU-OSHA (European Agency for Safety and Health at work)
Occupational skin diseases cost EU € 600 million / year
(= 3 million lost wd)

25. Benefits (3): Environmental Benefits
Examples:
EC JRC: Pollution prevention
Costs of dredging and clean-up contaminated soil/sewage sludge of at least €11 billion in the next decade for the EU15 alone (€ billion)
Nordic Council
Costs associated to PCB pollution between €15 up to 75 billion (up to 2018)
Finnish Ministry of Environment
Remediation of contaminated soil future clean-up costs for Finland up to €1.2 billion in the next two decades.
Benefits are difficult to estimate but significant and undisputed*
* NL workshop on REACH IA

26. Less than 0.1 % of yearly turnover over 11 years
11/13/2018
Costs
Impact Assessment:
Direct costs: €2 billion (range € billion).
Total costs (inc to downstream users): € billion
Substance loss: 1-2% (to be further investigated)
60 % of direct costs from testing
An indication of the amount of information industry has about its chemicals?
Less than 0.1 % of yearly turnover over 11 years
The knowledge gap REACH is designed to fill
P:\

27. Conclusion - REACH will ensure:
11/13/2018
Conclusion - REACH will ensure:
High level of protection
Burden of proof on those creating risks
better use of resources
Improved knowledge
information for downstream users
Improved innovation
Substitution of dangerous substances
particularly through authorisation
Better:
reaction to emerging risks
consumer confidence
Benefits
significantly
outweigh
costs
P:\

28. for a Sustainable REACH Implementation
Interim Strategy
The interim strategy has 4 basic work elements:
Aligning Dir. 67/548 and Reg. 793/93 with REACH
- Re-focus Current Activities
- Preparing for REACH
Developing Guidance Documents and Software Tools for efficient, transparent and consistent implementation
- Strategic Partnerships
- Setting up the Agency
“Working together, preparing for REACH”
Finland: Practical aspects COM: Organisation
The Interim Strategy prepares ALL stakeholders
for a Sustainable REACH Implementation

29. Information
Thank you!