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NOVÁ STRATEGIE EU V OBLASTI CHEMICKÝCH LÁTEK REACH Karel Bláha Odbor environmentálních rizik

NOVÁ STRATEGIE EU V OBLASTI CHEMICKÝCH LÁTEK REACH Karel Bláha Odbor environmentálních rizik Ministerstvo životního prostředí. REACH – a little history. Feb 2001 White Paper published May 2003 Internet consultation launched: 6000+ comments received

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NOVÁ STRATEGIE EU V OBLASTI CHEMICKÝCH LÁTEK REACH Karel Bláha Odbor environmentálních rizik

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  1. NOVÁ STRATEGIE EU V OBLASTI CHEMICKÝCH LÁTEK REACH Karel Bláha Odbor environmentálních rizik Ministerstvo životního prostředí

  2. REACH – a little history • Feb 2001White Paper published • May 2003Internet consultation launched: 6000+ comments received • Aug/Sep 2003Proposals substantially amended as result of comments • 29 Oct 2003Draft REACH regulation adopted by Commission • 20 Nov 2003 Ad-hoc Working Group established

  3. Ad-hoc WG calendar, 2004 • Jan12/13Scope, registration • Feb 2/3Data Sharing, Info in the Supply Chain, Downstream users • Feb 23/24Authorization, Restrictions, Classification • March 15/16 Restrictions, Classification, Agency • April 5/6 Information, Competent Authorities, Enforcement • April 29/30 2nd reading – Titles I and II • May 24/25 • June 14/15

  4. REACH: main features • Registration of substances above 1 tonne • Evaluation by the Member States • Authorisation for substances of very high concern • Restrictions - the safety net • Agency to manage the system

  5. Scope • REACH covers • Manufacture, import, placing on market and use of substances • Substances “on their own”, in preparations or in articles • General exemptions from scope of REACH listed in Article 2 • Specific exemptions from parts of REACH set out in those Titles • Generally, the authorisation and restrictions titles have a wider scope than the registration title

  6. Registration ….. obliges manufacturers and importers to obtain information on their substances and to use this knowledge to ensure responsible and well-informed management of the risks the substances may present

  7. Deemed to be Registered Overview Obligation to Register • Manufacturer • Importer • EU Representative of non-EU manufacturer General : Full Dossier Special : Reduced Dossier • 1 t/yr per M/I • Monomers • Substances in articles (conditions apply) Exemptions • Uses covered by other legislation • Annex II (well known) • Annex III (by-products etc) • PPORD (time limited) • Re-importation Isolated intermediates • on-site • Transported Exemptions • Polymers (subject to review) • Biocide • Pesticide • Notified substances (67/548/EEC)

  8. PPORD • Wide definition • 5-year exemption – notification required • 4 weeks delay before manufacture or import • Agency may impose conditions • Extension by up to 5 years • Extension by up to 10 years for medicines • Decisions by Agency • Draft decisions to MS Competent Authorities • All information treated as confidential

  9. Substances in Articles Requirements apply 11 years after entry into force • Meet the criteria for classification as dangerous • > 1 t/yr per article type per M/I • Not registered further up the supply chain • Known to be released and • Quantity released may adversely affect human health or the environment Intended to be released General obligation to register Obligation to notify the Agency Agency may require registration

  10. Timetable • Non phase-in (‘new’) substances  ‘immediately’ (60 days after entry into force) • Phase-in (‘existing’ substances) • 1000 t per year per M/I  3 years • CMR cat. 1 & 2  3 years • 100 t per year per M/I  6 years • 1 t per year per M/I  11 years • Substances in articles  11 years

  11. Consortia • Encouraged • Share data • Share costs • Avoids animal/repeat testing • 1/3 registration fee • Some data submitted on behalf of the consortium • Some data submitted per registrant

  12. Information Requirements TECHNICAL DOSSIER • Common information for all registrations • Annex IV • Depending on tonnage threshold • > 1 t/yr  Annex V • > 10 t/yr  As above + Annex VI • > 100 t/yr  As above + proposals for Annex VII • > 1000 t/yr  As above + proposals for Annexes VII and VIII Chemical Safety Report (CSR) if > 10 t/yr

  13. Registration Annexes • Annex V • Physicochemical properties • Basic human health data (4 end-points) • Short term aquatic toxicity • Annex VI • Human health data (including in vivo) • Ecotoxicological data • Annex VII and Annex VIII • Long term, repeat dose, chronic, fate etc Exemptions built into Annexes V to VIII

  14. Generation of Information • (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 See Annex IX = F L E X I B I L I T Y !

  15. Chemical Safety Assessments • Per substance or per group of substances • Concentration limits apply (substances and preparations) • 0.1 % for PBTs and vPvBs • Exposure scenarios • Summarised in CSRs and information passed downstream in Safety Data Sheets (SDS)

  16. Chemical Safety Assessments 6 steps • Human health hazard assessment • Human health hazard assessment of physicochemical properties • Environmental hazard assessment • PBT and vPvB assessment ----------- if dangerous or a PBT or vPvB --------- • Exposure assessment incl exposure scenarios • Risk characterisation

  17. Role of the Agency • Completeness check • 3 weeks • within 3 months of registration deadline for ‘late’ registration of ‘phase-in’ substances • Further information to Agency by deadline • Deadline missed = no registration • Appeal possible • Information to relevant MS CA

  18. Downstream Users (1) • Registration by manufacturers or importers must cover all “identified uses”, i.e.: • Uses that he intends to market the substance for, or to use the substance for himself; • Uses that are identified to him by DUs. • Downstream users have a right to identify a use; or may choose to keep a use confidential. • In the latter case, the DU has to notify his use to the Agency.

  19. Downstream Users (2) • In practice • Manufacturer develops exposure scenario(s) to cover all identified uses; • DU role in this will vary from case to case; • Exposure scenarios can be narrow or wide; • Exposure scenarios communicated to DUs via safety data sheets (SDSs); • SDSs and exposure scenarios are the trigger for deciding if the DU has to take further action.

  20. Downstream Users (3) • DU takes no further action in the following cases: • He is operating inside an exposure scenario communicated to him in a SDS; • A SDS is not required for the substance (e.g. it is not hazardous); • A CSR is not required to be completed by his supplier (e.g. he produces the substance below 10 tonnes)

  21. Downstream Users (4) • The DU must complete a CSR and report to the Agency in the following cases : • He is operating outside an exposure scenario communicated to him in a SDS; • He has chosen to keep his use secret.

  22. Downstream Users (5) • DU report is not a registration • He simply informs the Agency of his and his supplier’s identity, the identity of the substance and a generic use description • In a small number of cases, he may propose testing • Reporting not required for small quantities (below 1 tonne)

  23. Downstream Users (6) • SDS is main tool for communicating information downstream • Dir 91/155 incorporated in REACH • SDSs have same scope as before; but have additional role as communicator of exposure scenarios and trigger for DU action • Also duties to pass other relevant information down the supply chain when SDSs not required; and up the supply chain when relevant new HSE information arises.

  24. DATA SHARING – GENERAL RULES Information • on intrinsic properties of substances • > 10 years freely available • < 10 years: • Sharing of data and cost • Different rules for non-phase-in and phase-in substances • No obligation to share tests not involving vertebrate animals (declaration in registration)

  25. NON-PHASE-IN SUBSTANCES • Potential registrants consult database and Agency: Is same substance registered? • Agency enables contact with previous or other potential registrants • Studies involving vertebrate animals shall not be repeated • Registrants shall take all reasonable steps to reach an agreement • If not: Agency shall make studies available to potential registrant, previous registrant gets 50% of the cost and may request that waiting period is extended • Other studies: potential registrants may ask for information that previous registrants are willing to share

  26. PHASE-IN SUBSTANCES Pre-registration  database • Potential registrants submit info on available studies at the latest after 1,5 (> 1000t) or 4,5 yrs (> 1t) • Contributions by DU and M/I < 1t possible SIEF = Substance Info Exchange Forum • Potential registrants of same substance  Access to database for that substance Within SIEF • Aim: exchange info to minimise duplication of tests • Study not available: participants agree who performs it • Study available: participants agree on sharing cost, otherwise equal shares • Sharing of tests involving vertebrate animals mandatory • if participant refuses to share => sanctions • testing allowed by rest of SIEF

  27. CONSORTIA S E P A R A T E L Y C H O I C E O N E F O R A L L Identification of manufacturer or importer Identification of substance Information on manufacture and use Statement whether information has been generated by testing on vertebrate animals Guidance on safe use Chemical Safety Report Classification and labelling Summaries and robust study summaries of information derived from application of Annexes V to IX Proposals for testing where required for the application of Annexes V to IX

  28. Article 40Compliance check, esp. waiving statements require information needed for compliance EVALUATION clarify the suspicion of risks to human health or the environment of a substance prevent animal tests + ensure high quality of tests ensure high quality of dossiers submitted D O S S I E R E V A L U A T I O N S U B S T A N C E E V A L U A T I O N Article 39Examination of testing proposals  request to carry out the tests Article 44Request for further information Registrants submit information required Registrants submit information required Registrants submit information required Check of information submitted  conclusion Check of information submitted  conclusion Check of information submitted  conclusion

  29. DOSSIER EVALUATION SUBSTANCE EVALUATION COMPETENT AUTHORITY • CA of Member State where manufacture takes place or importer is established • Consortia: CA of Member States of the manufacturer or importer who submits information on behalf of others • CA of a Member State that has included the substance in its definitive Rolling Plan (RP) • Draft RP shall take account of prioritisation criteria by Agency • If only one MS: CA of that MS • If two or more MS have included the substance or expressed an interest: • MS-Committee: agreement(GDP+dossier evaluation) • Commission decision  Adoption of definitive RP

  30. Amended Draft Decision Amendments Amendments Decision M S C O M M I T T E E Agreement Opinion EVALUATION PROCEDURE Commission M e m b e r S t a t e s Registrants / DU CA Agency Draft Decision Comments Amended Draft Decision Amended Draft Decision Comments Modified DD Decision Decision 130 (2)

  31. Authorisation (1) Criteria for substances subject to authorisation: (a) carcinogenic substances, cat. 1 and 2 (b) mutagenic substances, cat. 1 and 2 (c) reprotoxic substances, cat. 1 and 2 (d) PBTs (Annex XII criteria) (e) vPvBs (Annex XII criteria) (f ) causing serious, irreversible effects to humans or the environment which are equivalent to those listed under (a) to (e); case-by-case decision, Art. 56 procedure

  32. Authorisation (2) • Applies to a M, I, DU who places a substance on the market for a use or uses it himself • No volume threshold, registration not required • Series of exemptions • Granting of an authorisation: • COM shall grant an authorisation if the risks are adequately controlled as documented in the CSR • If not, it may be granted if the socio-economic benefits outweigh the risk and if there are no suitable alternative substances or technologies

  33. Authorisation (3) Inclusion of a substance in Annex XIII: • Agency recommendation of priority substances, subject to public comments • regulatory committee procedure • specification of • identity + intrinsic property • sunset date and application date • exemptions • review periods

  34. Authorisation (4) Application for an authorisation • Submitted to the Agency • Grouping of substances or uses • Required information: • Identity of substance + applicant • If not registered: CSA covering the risks triggering inclusion in Annex XIII • Optional information: • Socio-economic analysis • Analysis of the alternatives

  35. Authorisation (5) Procedure for authorisation decisions • Agency’s RA Comm. and SEA Comm. provide draft opinions, based on • Information contained in the application • Information from third parties on alternative substances or technologies possibility to comment on the draft opinions by the applicant • Committees consider these comments when adopting their final opinions • Agency forwarding them to COM, MS and applicant, non-confidential parts to be published • COM to prepare a draft decision:  advisory committee procedure

  36. Restrictions • Any substance on its own, in a preparation or in an article • POPs • Current restrictions under 76/769/EC continue (recast: Annex XVI) • CMRs for consumer use – current restrictions will continue to apply – ‘fast track’ • R&D below 1 t/yr  exempted • Waste being treated  exempted • Use in cosmetics  exempted

  37. Process (1) • Member State Dossier (Annex XIV) • Proposal • Technical and scientific basis (risk assessment) • Justification for action at Community level • Socio-economic assessment • Other information (consultation)

  38. Process (2) • MS Dossiers submitted to Agency • Decision by Committees within 30 days • Reasons for negative decision within 45 days • Further 30 days to make Dossier conform • Conforming MS Dossiers published on Agency website • Interested parties given 3 months to • Comment on Dossier (e.g. risk assessment) • Contribute to socio-economic impact

  39. Risk Assessment Committee 9 months to formulate an opinion Opinion takes account of Dossier Comments on Dossier Socio-economic Analysis Committee 12 months to formulate an opinion Draft opinion published on Agency website and comments invited Opinion takes account of Dossier Comments on Dossier Comments received on draft opinion Process (3)

  40. Process (4) • Agency submits opinions to Commission • Agency publishes opinions on website • Commission proposal within 3 months • Divergence from opinions to be justified • Final decision by Regulatory Procedure • Restriction(s) added to Annex XVI

  41. Agency (1) • Composed of: • Executive Director • Management Board (6 nominated by Council; 6 nominated by Commission; 3 non-voting members from stakeholders) • Committee for risk assessment (authorisations and restrictions) • Committee for socio-economic analysis (authorisations and restrictions) • Member State Committee (evaluation, C&L and identification of SVHC) • Forum (enforcement) • Technical and scientific Secretariat (registration, C&L, Agency decisions, management of committees) • Board of Appeal

  42. Classification and Labelling • Changes to C&L Directives to implement GHS - not in current REACH proposal but planned for next phase • Current legislation: C&L all substances placed on market; some substances harmonised in Annex I of 67/548 • REACH: in addition - industry to notify Agency of all substances C&Ld, applies 3 years after entry into force • Agency to maintain an inventory • Industry to make all efforts to harmonise the C&L of substances, where there are differences • Harmonisation by authorities required only for CMRs (cats 1,2 and 3) and respiratory sensitisers

  43. Confidentiality • Normal Community rules apply regarding access to information held by the Agency • the Agency will consult the party who submitted the information before deciding if it can be released • Agency decisions to release, or not release, info can be appealed against • Some information always considered as confidential • Some information always considered as non-confidential • All other information may be released on request, following the rules above

  44. Reviews and reports • MSs and Agency report to Commission on operation of REACH after 5 years, and then every 10 years • Commission publishes general report after 6 years and then every 10 years, based on above • Specifically: • The first Commission report will review the handling of substances between 1 and 10 tonnes • After 12 years, the Commission will review CSA/CSR requirements • When it is possible to accurately identify dangerous polymers, the Commission will review the handling of polymers under REACH

  45. Cost savings

  46. Impact Assessment (1) Direct costs to chemicals sector • Estimated testing and registration costs: € 2.3 bn • use of validated computer-based methods (QSARs) should allow significant reduction in costs Alternative QSAR Scenarios • Slower progress in validating QSARs + € 0.9 bn • Faster development of QSARs - € 0.4 bn

  47. Impact Assessment (2) Cost to downstream users (price increases and substitution costs) Based on € 2.3 bn direct costs: • Normal expectation scenario: € 2.8 - 3.6 billion • Higher substitution cost scenario: € 4.0 - 5.2 billion Benefits: Illustration - 10% effectiveness in reducing chemical diseases worth 4,500 lives per year, valued at € 50 billion

  48. CONCLUSIONS Expenses for registration - manufacturers 1,8 – 5,6 mld CzK Expenses for registration - manufacturers 0,2 – 0,6 mld CzK Expenses for authorization (one substance) 1,6 mil. CzK (+application) Expenses for registration of preparations Up to 10 mil of CzK

  49. Thank you for your attention blaha@env.cz

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