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:
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
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Unit C.3: Chemicals
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
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 +
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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
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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
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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
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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
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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
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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
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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!
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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
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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
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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
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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
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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.
Occupational Health Safety law
Integrated Pollution and Prevention Control
Water Framework Directive
Waste legislation
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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
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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