Transcript Chemicals

European Commission, DG Environment
Unit C.3: Chemicals
Introduction to
The New EU Chemicals Policy
REACH
Framing a Future Chemicals Policy
Boston
27 April 2005
Eva Sandberg
DG Environment, European Commission
European Commission, DG Environment
Unit C.3: Chemicals
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:
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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
European Commission, DG Environment
Unit C.3: Chemicals
Scope
REACH covers
Manufacture, import, placing on market and
use of substances
Substances “on their own”,
in preparations or in articles
European Commission, DG Environment
Unit C.3: Chemicals
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
European Commission, DG Environment
Unit C.3: Chemicals
Registration: general
AIM: Ensure industry adequately manages the risk from its substances
 Method:
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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
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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
European Commission, DG Environment
Unit C.3: Chemicals
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.
European Commission, DG Environment
Unit C.3: Chemicals
Registration: Deadlines
SIA
1 - 10 t
>1000 t + CMR
Yr 0
100 - 1000 t
Yr 0 +3
Yr 0 + 6
10 - 100t
Yr 0 + 11
2017 +
European Commission, DG Environment
Unit C.3: Chemicals
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
European Commission, DG Environment
Unit C.3: Chemicals
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
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Unit C.3: Chemicals
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
European Commission, DG Environment
Unit C.3: Chemicals
Substances in Articles
 Meet the criteria for classification as dangerous
11 years and
3 months after
entry into force
(2017+)
 > 1 t/yr per article type per M/I
 Not registered further up the supply chain
 Known to be released and
Intended to be released
General obligation to register
 Quantity released may
adversely affect human health
or the environment
Obligation to notify the Agency
Agency may require registration
European Commission, DG Environment
Unit C.3: Chemicals
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
European Commission, DG Environment
Unit C.3: Chemicals
Consortia
Individual
Choice
Identity of M/I
Identity of the
substance
Information on
manufacture and use
Statement whether
information has been
generated by testing
on vertebrate
animals
Guidance on safe
use
Chemical Safety
Report
« One for all »
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
European Commission, DG Environment
Unit C.3: Chemicals
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
European Commission, DG Environment
Unit C.3: Chemicals
Evaluation
Provide confidence that industry is meeting obligations
Prevent unnecessary testing
Dossier evaluation
Check test proposals
Compliance
Substance evaluation
Examine any information on
a substance
Output:
• Further information decisions
• Info to other parts of REACH/other legislation
European Commission, DG Environment
Unit C.3: Chemicals
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
European Commission, DG Environment
Unit C.3: Chemicals
Authorisation
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!
European Commission, DG Environment
Unit C.3: Chemicals
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
European Commission, DG Environment
Unit C.3: Chemicals
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
European Commission, DG Environment
Unit C.3: Chemicals
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
European Commission, DG Environment
Unit C.3: Chemicals
Progress in decision-making
Nov 2003: Proposal submitted to Parliament
and Council
Decision making in EP and Council:
2004-2006
 Political agreement between MS: end 2005?
 Parliament 1st reading: October 2005?
REACH in force: 2007?
European Commission, DG Environment
Unit C.3: Chemicals
Key issues
1. Prioritisation (Registration)
 Right balance
 Short/long term impacts
2. 1-10 tonnes: Testing requirements
3. OSOR
 Mandatory sharing of all data
 Workability of agreement
4. Authorisation/substitution
5. Agency
 Stronger role in evaluation
6. Substances in Articles
 Balance between protection, workability and WTO concerns
European Commission, DG Environment
Unit C.3: Chemicals
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.
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Occupational Health Safety law
Integrated Pollution and Prevention Control
Water Framework Directive
Waste legislation
European Commission, DG Environment
Unit C.3: Chemicals
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 costbenefit 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)
European Commission, DG Environment
Unit C.3: Chemicals
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 (€11-110 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
European Commission, DG Environment
Unit C.3: Chemicals
Costs
Impact Assessment:
 Direct costs: €2 billion (range €1.6 - 2.9 billion).
Less than 0.1 % of yearly turnover over 11 years
 Total costs (inc to downstream users): €2.8 - 3.6 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?
The knowledge gap REACH is designed to fill
European Commission, DG Environment
Unit C.3: Chemicals
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
European Commission, DG Environment
Unit C.3: Chemicals
Interim Strategy
The interim strategy has 4 basic work elements:
- Re-focus Current Activities
- Preparing for REACH
- Strategic Partnerships
Aligning Dir. 67/548 and Reg.
793/93 with REACH
Developing Guidance Documents
and Software Tools for efficient,
transparent and consistent
implementation
- 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
European Commission, DG Environment
Unit C.3: Chemicals
Information
http://europa.eu.int/comm/environment/chemicals/index.htm
http://europa.eu.int/comm/enterprise/chemicals/index.htm