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REACH Regulation Basic requirements

REACH Regulation Basic requirements. Semira Hajrlahović Mehić, LL.M., B. Sc. Tatjana Humar-Jurič, M.Sc. Content. Background / Objectives / Scope REACH Core elements ECHA Conclusions Good to know. Negotiations Before and after proposal of October 2003 13 . 12 . 2005: political agreement

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REACH Regulation Basic requirements

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  1. REACH Regulation Basic requirements Semira Hajrlahović Mehić, LL.M., B. Sc. Tatjana Humar-Jurič, M.Sc. REACH Regulation Basic requirements

  2. Content • Background/Objectives/Scope • REACH Core elements • ECHA • Conclusions • Good to know REACH Regulation Basic requirements

  3. Negotiations Before and after proposal of October 2003 13.12. 2005: political agreement End 2006: European Parliament and Council agreement Regulation 1907/2006 Content of REACH A whole lot… Very complex… REACH replaces > 60 directives and regulations Background REACH Regulation Basic requirements

  4. REACH Regulation • REGULATION (EC) No.1907/2006 of the European Parliamenet and of the Council of 18 December 2006concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing CouncilRegulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC • REACH • Registration • Evaluation • Authorisation of CHemicals REACH Regulation Basic requirements

  5. Different chemical policies for: Existing Substances 100,106 substances; 99% of market volume; Risk assessments for ± 140; Focus on > 1,000 tpa New Substances ca. 3,000 substances; Notification from > 10kg pa Furthermore Many existing substances not risk assessed Call for reducing animal tests Some starting points  not good for man and the environment  Differences not good for internal market REACH Regulation Basic requirements

  6. REACH in a bookshelf I II III IV V VI VII VIII IX X XI XII XIII XIV XV Titles: I II III IV V VI VII VIII IX X XI XII XIII XIV XV XVI XVII Annexes: Technical guidance………. REACH Regulation Basic requirements

  7. Manufacturer (M) Importer (I) Downstream user (DU) Agency European Commission Member States Policy level Execution level Inspection / Enforcement Third parties ECHA (Helsinki) Central role Facilitating Executive Partly paid through fees Who are the players? REACH Regulation Basic requirements

  8. REACH “logic” • One single and coherent system for: • New and existing substances • Hazardous and non hazardous substances • Shift of responsibilities: • public authorities  industry • No data, no market REACH Regulation Basic requirements

  9. REACH Objectives • Protection of the human health and the environment • Promotion of alternative methods • Free circulation on the internal market • Enhancing competitiveness and innovation REACH Regulation Basic requirements

  10. REACH Core elements • Registration of substances ≥ 1 tonne/yr (staggered deadlines) • Information in the supply chain • Evaluation of some substances by Member States/ECHA • Authorisationonly for substances of very high concern • Restrictions - the safety net • Agency (ECHA) to manage system REACH Regulation Basic requirements

  11. Registration Evaluation Authorisation Restrictions > 1 tonne/yr > 10 tonnes/yr + substances of concern CMR & PBT & equivalent concern Substances of concern REACH.Registration, Evaluation, Authorisation and restriction of CHemicals REACH Regulation Basic requirements

  12. REACH Focus • Priorities • high volumes (as a proxy for potential risk) • greatest concern (substances & uses with highest risk) REACH Regulation Basic requirements

  13. No data, no market • Article 5 “ Subject to Articles 6, 7, 21 and 23, substances on their own, inpreparations or in articles shall not be manufactured in theCommunity or placed on the market unless they have beenregistered in accordance with the relevant provisions of thisTitle where this is required” REACH Regulation Basic requirements

  14. Title II: Registration • Manufacturers/Importers • Registration for substances ≥ 1 tonne per year • Chemical Safety Report (CSR) for all substances ≥ 10 t per year REACH Regulation Basic requirements

  15. Scope of the Regulation • REACH applies to the manufacturing, import, placing on the market and use of substances • On their own, in preparations, in articles • Exemptionsfor certain: • Substances • Uses of substances • Reduced obligations • R&D, polymers and intermediates REACH Regulation Basic requirements

  16. Registration Aim • Manufacturers and importers obtain information on their substances • Use this knowledge to ensure responsible and well-informed management of the risks these substances may present throughout their life cycle REACH Regulation Basic requirements

  17. What is Registration • Submission of Dossier (Documentation) • In case of absence of available information, tests may be conducted • Data sharing (in particular for vertebrate tests) • Substance Information Exchange Fora(SIEFs) REACH Regulation Basic requirements

  18. What is Registration • Registration Dossier = Documentation • Technical Dossier: • starting at 1 tonnes per year • IUCLID 5 • Chemical Safety Report: • starting at 10 tonnes per year REACH Regulation Basic requirements

  19. Who has to register? Manufacturers of substances and producers of articles with intended release: Each legal entity must register separately May appoint Third Party Representative Importers Non-EU manufacturer may appoint Only Representative instead In such cases, Only Representatives is liable for registration and importer is considered as downstream user REACH Regulation Basic requirements 9/18/2014 19

  20. RegistrationExceptions • PPORD (notification still needed) • for 5 years • plus 5 or 10 (medicines) years • Pesticides (and co-formulants) • Active ingredients of biocidal products • Reduced registration for some (on-site and transported) intermediates • Joint submission of data (OSOR) • Mandatory sharing of data REACH Regulation Basic requirements

  21. Reach time table phase-in substances → pre-registration (finished 1.12.2008) • CMR cat. 1,2 > 1 t/y (1.12. 2010) • R50-53 subst. > 100 t/y (1.12. 2010) • EINECS subst. > 1000 t/y (1.12. 2010) • EINECS subst.> 100 t/y(1.06. 2013) • EINECS subst.> 1 t/y(1.06. 2018) Obligation to register →since 1. 06 2008. Prolongation only for pre-registered substances . REACH Regulation Basic requirements

  22. Reach time table Pre-registration REACH entry into force >1000 tonnes CMRs ( > 1 tonne) Very toxsic to aquatic organisms (R50/53) (> 100 tonnes) 100-1000 tonnes 1-100 tonnes Non phase-in substances 30.11. 2010 31.05. 2013 31.05. 2018 1.06. 2007 1.06. 2008 1.12. 2008 REACH Regulation Basic requirements

  23. Substance intended to be released (regardless of hazard) > 1 tonne / year per Manufacturer / Importer (Not registered for that use) General obligation to Register Substance of Very High Concern(CMRs, PBTs and vPvBs.) Placed on candidate list for authorisation Concentration of > 0.1 % weight-by-weight Obligation to notify the Agency Substances in Articles (Article 7) REACH Regulation Basic requirements

  24. Title III: Data Sharing • Pre-SIEFformation • Industry pre-registers • ECHA makes contact details available on restricted website • SIEFFormation • Process led by industry • Data sharing • Process led by industry • Joint submission • Industry registers • Data sent to evaluation (ECHA, MS) Both data sharing and joint submission are obligatory! REACH Regulation Basic requirements

  25. Joint submission Obligatory joint submission: information on the hazard properties of the substance classification and labelling Voluntary joint submission: Chemical Safety Report (CSR) (for substances >10 t/a) Guidance on safe use Individual submission: Identity of manufacturer and substance Identified uses Exposure information (for substances in 1-10t tonnage band) REACH Regulation Basic requirements 9/18/2014 25

  26. Title IV: Information in the supply chain • Supplier shall provide SDS to recipient, where: • Substance is hazardous (1272/2008) • Substance is PBT or vPvB • SDS shall contain relevant exposure scenario REACH Regulation Basic requirements

  27. Title V: Downstream User • Implement risk management measures communicated to him via the Exposure Scenarios (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 REACH Regulation Basic requirements

  28. Title VI: Evaluation Objective • To verify lack of adverse effects to human health and the environment • To prevent unnecessary use of animal tests Two evaluations • Dossier evaluation (including test proposals; initiated by registrant, mandatory) • Substance evaluation (initiated by Member State / Commission, voluntarily) REACH Regulation Basic requirements

  29. Title VI: Evaluation • Dossier Evaluation : • ECHA • Checking compliance of registration dossiers • Checking of test proposals • Priority to hazardous substances, CMR, resp. sensitizers, PBT, vPvB • Substance evaluation: • MSCA • Checking whether there is a need for further information on a substance REACH Regulation Basic requirements

  30. Titles VII: Authorisation • To ensure good functioning of the internal market • While assuring that risks are properly controlled (substitution) • No placing on the market for substance on Annex XIV, unless it is authorised REACH Regulation Basic requirements

  31. Titles VII: Authorisation • Only applies to Substances of Very High Concern, once included in Annex XIV: • CMR (carcinogenic, mutagenic, toxic for reproduction) • PBT/vPvB (persistent, bioaccumulative, toxic) • substances of equivalent concern (endocrine disruptors, others) • Identification of SVHC • Candidate list15 substances is published http://echa.europa.eu/chem_data/candidate_list_table_en.asp ) • Priority list for inclusion into Annex XIV • Inclusion in Annex XIV (comitology decision) REACH Regulation Basic requirements

  32. SVHC:Information Requirements Suppliers must provide sufficient information, available to the supplier, to clients to allow the safe use of the article including, as a minimum, the name of that substance, if: They have been identified on the candidate list The substance is present > 0.1% w/w On request by consumers, suppliers must provide the consumers with the above information within 45 days Obligation starts immediately aftersubstance was put on the candidate list! REACH Regulation Basic requirements 9/18/2014 32

  33. Title VIII:Restriction • Only minor changes compared to existing system (Directive 76/769/EEC) • In addition to “marketing & use”, now also manufacturing covered REACH Regulation Basic requirements

  34. Titles VII & VIII Authorisation and Restriction Formal procedure Substances of Very High Concern Annex XIV substances CMR, PBT, vPvB, ‘equivalent concern’ Application by COM or Member State on basis of CSR and SEA Application by M, I, or DU for limited time and scope on basis of CSR, SEA may be used Authorisation (also on Annex XIV) Restriction (Annex XVII) REACH Regulation Basic requirements

  35. Title XI: Classification & LabellingInventory REACH does NOT include CRITERIA for C&L!!! • It refers to: • Substance Classification  Directive 67/548/EEC • Preparation Classification  Directive 1999/45/EC These references are adaptedCLP Reg. 1272/2008 • But has links to C&L • Registration • Information in the supply chain • C&L Inventory – Title XI; moved to CLP Title V REACH Regulation Basic requirements

  36. DG?? DGEMP DGENT DGENV Council Title X : ECHA Commission Agency C’RA Industry Management Board C’SEA Downstream users Secretariat MS Committee Forum Manufacturers Importers Standing Committee Enforcement Authorities National representative Competent Authorities Experts Member States REACH Regulation Basic requirements

  37. ECHA ECHA today:  300 staff Started to manage the registration and evaluation First steps in authorisation Guidance / IT tools Helpdesk(s) Committees + Forum established Stakeholder involvement + consultations started ECHA in future: Up to 450 staff Will have an important role in authorisation and restriction REACH Regulation Basic requirements

  38. Title XIV: Enforcement • Agency hosts Forum for coordinating activities • There must be legal basis to sanction non-compliance • Penalties must be effective, proportionate and dissuasive • A frequent report should be issued by each MS Enforcement is national engagement, working on the basis of national legislation! REACH Regulation Basic requirements

  39. REACH Annexes • ANNEX IGENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS • ANNEX IIGUIDE TO THE COMPILATION OF SAFETY DATA SHEETS • ANNEX IIICRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES • ANNEX IVEXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a) • ANNEX VEXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b) • ANNEX VIINFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10 • ANNEX VIISTANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE • ANNEX VIIISTANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE • ANNEX IXSTANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE REACH Regulation Basic requirements

  40. REACH Annexes • ANNEX XSTANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE • ANNEX XIGENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X • ANNEX XIIGENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS • ANNEX XIIICRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES • ANNEX XIVLIST OF SUBSTANCES SUBJECT TO AUTHORISATION • ANNEX XVDOSSIERS • ANNEX XVISOCIO-ECONOMIC ANALYSIS • ANNEX XVIIRESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES REACH Regulation Basic requirements

  41. Conclusions • Players • Shift in responsibility, while authorities keep some • ECHA is important • Replacing animal tests • Good: reduce of costs and number of test animals • For major endpoint (# of test animals and costs) no alternatives (yet) • Lots of validation and guidance needed • Sharing of test results (SIEF) does reduce # and $ REACH Regulation Basic requirements

  42. Conclusions Exposure scenarios • Could potentially lead to thousands of exposure scenarios per substance… • Much more exposure assessors need to be involved Evaluation • Requires different mindset • Resources for evaluation dependent on higher management (within authorities, industry and Commission) REACH Regulation Basic requirements

  43. Conclusions C&L • Fast, transparent, open to the public • Question how harmonisation between registrants will proceed • Role enforcement? Authorisation & Restriction • Good procedures: • 1st Annex XV • 2nd Authorisation [Annex XIV] or Restriction [Annex XVII] • Authorisations • Could become very complex • Procedure could take a long time REACH Regulation Basic requirements

  44. Conclusions Enforcement / Inspection • Success REACH depends on resources (quantity and quality) at Enforcement REACH Regulation Basic requirements

  45. Where to turn for help? Check the legislation (available in all EU languages) http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2006:396:SOM:EN:HTML Check the Guidance websitehttp://guidance.echa.europa.eu Check the Frequently Asked Questions on the ECHA website http://echa.europa.eu/reach/faq_en.asp Talk to colleagues, business associations, industry helpdesks Contact national helpdesk (addresses can be found on http://echa.europa.eu/reach/helpdesk/nationalhelp_en.asp ) REACH Regulation Basic requirements 9/18/2014 45

  46. Further Information http://echa.europa.eu http://ec.europa.eu/enterprise/reach/index_en.htm http://ec.europa.eu/comm/environment/chemicals/reach.htm http://ecb.jrc.it/REACH/ REACH Regulation Basic requirements

  47. Thank you! Semira.Mehic@gov.si Tatjana.Humar-Juric@gov.si REACH Regulation Basic requirements

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