Future legislation on chemicals and REACH processes

1. Future legislation on chemicals and REACH processes Jens Tørsløv European Chemicals Bureau Institute for Health and Consumer Protection Joint Research Centre

2. Contents • Why a new Chemicals Policy? • Main elements of REACH • REACH main changes

3. Why a new Chemicals Policy?

4. General Risk Assessment / Risk Management process Identification of ‘priority’ substances Data Generation Risk Assessment Identification of risk management measures Implementation of RMMs in Community legislation

5. Biocides Directive 98/8/EC 1993 2003 1994 2002 Legislative context New substances Existing substances Directive 92/32/EC Regulation (EC)793/93 Directive 93/67/EC Regulation (EC)1488/94 Technical Guidance Documents (1996) Technical Guidance Documents (2003)

6. Detailed procedures for risk assessment are given in the Technical Guidance Documents (TGD): man environment QSARs emission scenario documents Principles for risk assessment Freely available from the ECB web page http://ecb.jrc.it/tgdoc

7. TGD EUSES Basic Framework of Risk Assessment Process Data evaluation Exposure assessment Effects assessment Data set Single species toxicity data Emission rates Extrapolation Distribution PNEC PEC Risk characterization PEC/PNEC

8. Main successes of current legislation • Large data gathering and summarising process for HPVCs • Agreement on RA principles (TGD/EUSES) • Agreement on priority setting (HERO) • EU harmonised risk assessments for many controversial substances, forming the solid basis for EU wide risk reduction measures

9. Main Problems • Data gaps: 86% of HPVCs have less than base set data • The process takes (far) too much time • Burden of proof is on public authorities • Generally Downstream Users stay out of the picture, actual uses of chemicals remain unknown • The system is inefficient: Industry is faced with a myriad of directives and regulations • Administrative burden for new, mostly low volume, chemicals prevents innovation

10. REACH Registration, Evaluation and Authorisation of CHemicals

11. REACH objective • Sustainable Development • Protection of human health and the environment • Maintain/enhance innovation/competitiveness • Maintain the Internal Market • Increased transparency and consumer awareness • Integration with international efforts • Promotion of non-animal testing • Conformity to WTO obligations

12. REACH principle • Industry ensures manufacturing, placing on the market and use do not adversely affect human health or the environment • Manufacturers and importers assess and document that risks are adequately controlled • Manufacturers and importers communicate to downstream users how to control risks • Downstream users apply measures to control risks and communicate this further downstream

13. The EU accounts for 33% of the World Chemicals Sales

14. The EU chemical industry comprises 27 000 enterprises96% SME; 30% of sales; 37% of employment (1.3 million).

15. Main elements of REACH • Scope: • manufacturers, importers, professional users • substances, in preparations, in certain articles • mandatory data tonnage dependent • Chemical safety report • Safety data sheet Registration of all substances > 1 t/yr • Scope: • decisions for additional information • proposal for authorisation • proposal for restriction measures • Scope: • carcinogenic, mutagenic, reprotoxic substances (CMR-substances) • Endocrine disruptors • Persistent bioaccumulating toxic substances (PBTs or vPvBs) • Scope: • all other substances of high concern following risk assessment Evaluation by competent authorities Authorisation of certain hazardous substances Measures for substances of concern

16. REACH: KEY ELEMENTS • Introduces a Single Coherent System for new (non phase-in) and existing (phase-in) substances • Key elements: • Registration by industry of manufactured/imported chemical substances > 1 tonne/year (staggered dead-lines over 11years) • Increased information and communication throughout the supply chain • Evaluation of some registered substances (Agency and Member States) • Authorisation only for use of substances of very high concern • Restrictions: “Safety net” (Community wide action) • Chemicals Agency to efficiently manage the system • Focus on priorities: • High volumes (chemicals with greatest likely exposure register first) • Greatest concern (Carcinogenic, Mutagenic and Reprotoxic register first)

17. REACH - Registration AIM: Ensure industry adequately manages risks from substances  Manufacturers and importers obtain information on their substances and  use this knowledge to ensure responsible and well-informed management of the risks these substances may present throughout their life cycle  Documentation: Electronic Registration dossier submitted to Agency  Certain non-confidential information to central (largely public) database No formal acceptance - industry retain responsibility

18. REACH - Registration AIM: Ensure industry adequately manages risks from substances Scope • Substances  1 tonne/year per manufacturer/importer (M/I) • Exemptions: Some other law, Annex IV/V; polymers (review); R&D (PPORD) • Intermediates: Exempted or reduced requirements • Considered as registered: biocides, pesticides, notified/ELINCS substances (but only for the one who has notified !) • Consortia encouraged No formal acceptance - industry retain responsibility

19. REACH – Evaluation(by Agency and Member States) 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

20. REACH - Authorisation Ensure risks from substances of very high concern are properly controlled or that the substances are substituted. • Applies to • CMR, PBT, vPvB, ‘equivalent concern’ * • Substance, substance in preparation (unless below concentration limit), substance incorporated into an article. • Prioritised - Substances are progressively authorised (as resources allow) • Substance cannot be used unless it is authorised • Authorisation applicant (industry) to show: • adequate control of risks, or • social and economic benefits outweigh the risks and no suitable alternatives • Commission decision based on Agency opinion * CMR: Carcinogenic, Mutagenic or toxic to Reproduction * PBT: Persistent, Bio-accumulative and Toxic * vPvB: very Persistent and very Bio-accumulative

21. REA(R)CH - Restrictions Safety net • Community wide concern • Members States or Commission initiated • Agency Committees examine: • the risks, and • the socio-economic aspects involved • Commission - final decision • Carry-over of existing restrictions (76/769/EEC on marketing and use).

22. European Chemicals Agency • Day to day management of REACH • Technical, scientific and administrative aspects • Responsibilities: • Registration - reject or require completion of registration • Evaluation – main tasks in conduct; priority setting; coordination and harmonisation • Authorisation/restrictions - facilitate process; suggest priorities. • Secretariat for Forum and Committees • Deal with appeals - registration, R&D, evaluation, confidentiality • Location: Helsinki, Finland • Fully operational: Entry into force + 12 months (2008)

23. REACH main changes • One regulation replaces a number of legal acts on new/existing chemicals • Burden of proof for safe use shifted from authorities to industry • No registration – no manufacture or import • Registration for all substances manufactured or imported > 1 tonnes/yr • Chemical Safety Report for all substance substances manufactured or imported > 10 tonnes/yr

24. REACH main changes • Agency do not approve industry registration and chemicals safety report • Authorities evaluate selected dossiers for compliance with REACH • Authorities evaluate selected substances based on a priority setting • MS authorities are responsible for enforcement

25. REACH main changes • Communication in supply chain play an important role in preparing registrations • More precise information to the user on how to use substances/ preparations • Increase awareness among downstream users

26. New roles for the actors

27. New roles for the actors Main processes (actor underlined) • Registration • Downstream users • Authorisation

28. Registration • How to demonstrate safe use of chemical • Registration dossier • Information requirements • Chemical Safety Report • Exposure Scenarios -> Extended Safety Data Sheets

29. Registration AIM: Manufacturers and importers obtain information on their substances and use this knowledge to ensure responsible and well-informed management of the risks these substances may present throughout their life cycle Registration Dossier = Documentation  Technical Dossier: starting at 1 tonnes per year • Chemical Safety Report: starting at 10 tonnes/year No formal acceptance - industry retain responsibility

30. Fully in force + 12 m Start + 3 yr + 6 yr + 11 yr No of substances + 18 m 20.000 1 - 10 t Consortia formation registration Consortia formation registration Consortia formation registration Pre- registration Proposal Adoption Testing, Safety Assessment, Registration 2.600 1000 t + CMR ... 2.900100 - 1000 t 4.600 10 - 100 t 2000 2003 2010 2014 2019 2007 2008 Registration phase-insubstances

31. What is a pre-registration ? • Submission within 18 months of entry into force of a simple pre-registration dossier to the Agency: • Substance identity • Name and address of registrant • Expected dead-line for registration (tonnage dependant) • Other information (art 28(1)(d) • Substances not pre-registered have to be registered before marketing (similar to non-phase in)

32. Registration: Information requirements • Data on physicochemical and toxic properties • The higher the tonnage, the higher the standard information requirements (REACH Annex VII-X) • NB! All available data must be collected regardless of tonnage (REACH Annex VI – step 1)

33. Animal testing and data sharing • REACH aims to reduce the need for animal testing: • Annex XI provides for adaptation of standard data • Testing not technically possible • Exposure-driven testing • Alternative methods (QSAR/in vitro/grouping/read-across) • Testing proposal when vertebrate testing is needed • Substance Information Exchange Fora (SIEF) for the same pre-registered substances • ‘Mandatory’ sharing of vertebrate animal data

34. Testing only when necessary Read Across (Q)SARs In-vitro Endpoint Information: Annexes VII-XI • Waiving: • technical • exposure Existing information Last resort TESTING

35. Legal access to data on inherent properties • The registrant must have legal access to the study reports for data used for a registration • Cost sharing to be agreed in the Substance Information Exchange For a (SIEF) • NB! Mandatory sharing of vertebrate animal data

36. What is the Chemical Safety Report (CSR) ? • The CSR is the documentation of the Chemical Safety Assessment covering: • Hazard Assessment of the inherent properties; physicochemical and toxic properties • PBT and vPvB assessment* • and when substance is dangerous or PBT/vPvB • Exposure Assessment quantifying human and environmental exposure levels • Risk Characterisation • Development of Exposure Scenarios

37. Technical Dossier • Identity of substance • Manufacture and use • Classification and labelling • Guidance on safe use • Study summaries • Test proposals (if relevant) • Exposure information Substance to be registered > 10 tonne/year • Chemical Safety Report • Hazard and PBT Assessment Also • Chemical Safety Report • Hazard and PBT Assessment • Exposure Assessment • Risk Characterisation AND • Exposure Scenarios Subst. dangerous or PBT/vPvB Also Registration dossier - content

38. What is an Exposure Scenario (ES) ? • Conditions for use: • Process description (incl. quantity used) • Operational conditions (incl. frequency and duration of specified operations) • Risk Management Measures • process control (e.g. closed system, local exhaust) • emission control • personal protective equipment • good hygiene / working practise. • Other relevant information

39. Annex: ESs ESs ESs Safety Data Sheet How will the user know? Exposure Scenarios will be attached to the Safety Data Sheet (SDS) -> Extended Safety Data Sheets (e-SDS)

40. REACH actors • Registration • Downstream users • Authorisation

41. Downstream users • Obligation to identify and apply measures to control risks • Include this in communication to customers • Obligation to communicate up in supply chain • Obligation to report to authorities • Obligation to keep and update information • Right to make use known to supplier

42. Who is a Downstream User Distributor Manufacturer/importer Downstream users Formulator 1 Formulator 2 Industrial user 1) use as process aid 2) Incorporation into articles Professional user Consumer

43. The Downstream User Must: • Implement Operational Conditions and Risk Management Measures communicated to him via the exposure scenarios in the SDS Annex • If he uses the chemical outside the conditions described in the exposure scenario(s) • Inform his supplier of this use to make it an identified use • Alternatively: • Conduct a safety assessment for his own use (and for his downstream uses if he is a supplier) • Implement ES from own safety assessment • Report to the Agency • Communicate further down the supply chain if he is supplier

44. n y y n Simplified workflow: check of SDS/ES Check SDS/ES Make use/ use conditions known Use covered and conditions Comply with ES? Find alternative supplier Make DU CSA Implement suppliers ES n Conditions in place meat at least conditions in suppliers ES OK

45. Right to make use known to supplier • Manufacturer and importer: • may not know the use or conditions of use • need sufficient information in order to continue supply • Downstream User (DU): • need continued supply (own and customers use) • need an ES to reflect the use conditions in the market

46. Supplier Downstream user(s) Supply chain communication SDS including Exposure Scenarios (Recommended Risk Management Measures) Safety Data Sheet Identify use

47. Supplier Downstream user(s) Supply chain communication SDS including Exposure Scenarios (Recommended Risk Management Measures) Safety Data Sheet Identify use

48. Right to make use known to supplier • What should DU communicate? • Sufficient information for preparing ES • How to organize communication? • System developed for “brief description of use” • Standard Exposure Scenarios • Sector organizations have a key role in developing standard Exposure Scenarios for their sector

49. REACH actors • Registration • Downstream users • Authorisation

50. Authorisation • Applies to • CMR, PBT, vPvB, ‘equivalent concern’ • Substance, substance in preparation, substances in articles. • Prioritised - Substances are progressively authorised (as resources allow) • Substance cannot be used unless it is authorised • Authorisation applicant (industry) to show: • adequate control of risks, or • social and economic benefits outweigh the risks and no suitable alternatives • Commission decision based on Agency opinion