European Commission, DG Environment Unit C.3: Chemicals Introduction to The New EU Chemicals Policy REACH Framing a Future Chemicals Policy Boston 27 April

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 SandbergDG Environment, European Commission


Unit C.3: Chemicals

A Tiered Approach

What is REACH?

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)

HIGH level of health and environmental protection with the goal of achieving sustainable development.


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


Unit C.3: Chemicals

European Chemicals Agency

Day to day management of REACHTechnical, scientific and administrative aspects

Responsibilities:Registration - reject or require completion of registrationEvaluation - ensure a harmonised approach; take decisions.Substances in articles - require registrationAuthorisation/restrictions - facilitate process; suggest

priorities.Secretariat for Forum and CommitteesDeal with appeals - registration, R&D, evaluation,

confidentiality


Unit C.3: Chemicals

AIM: Ensure industry adequately manages the risk from its substances

Registration: general

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


Unit C.3: Chemicals

REACH = large-scale information collection ≠ large-scale testing.

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


Unit C.3: Chemicals

Yr 0 Yr 0 +3 Yr 0 + 6 Yr 0 + 11

2017 +

>1000 t + CMR 100 - 1000 t 10 - 100t

1 - 10 t

Registration: DeadlinesSIA


Unit C.3: Chemicals

Generation of Information

Annex IX = F L E X I B I L I T Y

(Q)SARsUse of category approachesAnalogs, read acrossAvailable data (non-EU, GLP, non-GLP)Exposure based waiving (Annexes VII and VIII)Historical human dataData sharing (existing and new)

Testing (in vitro, in vivo) as a last resort


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 ReportPart of the registration dossier

Exemptions for substances in preparations below certain concentration limits

Defined in Annex I Includes

Human health hazard assessmentEnvironmental hazard assessmentPBT and vPvB assessment


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


Unit C.3: Chemicals

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

Intended to be released

General obligation to register

Known to be released and

Quantity released may adversely affect

human health or the environment

Obligation to notify the Agency

Agency may require registration

11 years and

3 months after entry into force

(2017+)


Unit C.3: Chemicals

Data sharing

Information > 10 years – freely availableNon-phase-in substances (= new):

Already registered?Agency enables contact - 50% cost sharingStudies involving vertebrate animals not repeated

Phase-in substances (= existing):Potential registrants of same substance: ‘SIEF’Sharing mandatory (vertebrate animals), if participant

refuses to share = sanctionsEqual sharing of costs

Avoidance of unnecessary animal testing + save costs


Unit C.3: Chemicals

Consortia

Individual Choice « One for all »

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

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


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 risksdownstream users brought into the systemdialogue up/down the supply chain

-encouraged/stimulated

Encourage communication Improve risk management


Unit C.3: Chemicals

Provide confidence that industry is meeting obligations

Prevent unnecessary testing

Evaluation

Dossier evaluation Substance evaluation

Check test proposals Compliance

Output:

• Further information decisions

• Info to other parts of REACH/other legislation

Examine any information on a substance


Unit C.3: Chemicals

Authorisation

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

AIM: Ensure risks from Substances of Very High Concern (SVHC) are properly controlled or that they are substituted.


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!


Unit C.3: Chemicals

Safety net

Restrictions

Community wide concernMS/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 comitologyCarry-over of existing restrictions (76/769/EEC)POPs


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


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 phaseProposal for a regulation either part of REACH or separateWill replace Directives 67/548 and 99/45


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?


Unit C.3: Chemicals

Key issues1. 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


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


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 Assessment18 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)


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


Unit C.3: Chemicals

The knowledge gap REACH is designed to fill

Costs

Impact Assessment:Direct costs: €2 billion (range €1.6 - 2.9 billion).

Total costs (inc to downstream users): €2.8 - 3.6 billion Substance loss: 1-2% (to be further investigated)

60 % of direct costs from testingAn indication of the amount of information industry has about its chemicals?

Less than 0.1 % of yearly turnover over 11 years


Unit C.3: Chemicals

Benefits

significantly

outweigh

costs

Conclusion - REACH will ensure:High level of protectionBurden of proof on those creating risks

better use of resourcesImproved knowledge

information for downstream usersImproved innovationSubstitution of dangerous substances

particularly through authorisationBetter:

reaction to emerging risks consumer confidence


Unit C.3: Chemicals

- Re-focus Current Activities

- Preparing for REACH

- Strategic Partnerships

- Setting up the Agency

“Working together, preparing for REACH”

Aligning Dir. 67/548 and Reg. 793/93 with REACH

Developing Guidance Documents and Software Tools for efficient, transparent and consistent implementation

Finland: Practical aspects

COM: Organisation

The interim strategy has 4 basic work elements:

Interim Strategy

The Interim Strategy prepares ALL stakeholdersfor a Sustainable REACH Implementation


Unit C.3: Chemicals

Information

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

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