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 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.

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 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

European Commission, DG Environment 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

European Commission, DG Environment Unit C.3: Chemicals Yr 0Yr 0 +3Yr 0 + 6Yr >1000 t + CMR t t t Registration: Deadlines SIA

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

European Commission, DG Environment 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  > 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+)

European Commission, DG Environment Unit C.3: Chemicals Data sharing  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 Avoidance of unnecessary animal testing + save costs

European Commission, DG Environment Unit C.3: Chemicals Consortia IndividualChoice« 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

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 Provide confidence that industry is meeting obligations Prevent unnecessary testing Evaluation Dossier evaluationSubstance evaluation Check test proposalsCompliance Output: Further information decisions Info to other parts of REACH/other legislation Examine any information on a substance

European Commission, DG Environment 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.

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 Safety net Restrictions  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:  Political agreement between MS: end 2005?  Parliament 1 st 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 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.  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 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)

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 (€ 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 The knowledge gap REACH is designed to fill 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

European Commission, DG Environment Unit C.3: Chemicals Benefits significantly outweigh costs 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

European Commission, DG Environment 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 stakeholders for a Sustainable REACH Implementation

European Commission, DG Environment Unit C.3: Chemicals Information