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

2. REACH Regulation Basic requirements2 Content Background/Objectives/Scope REACH Core elements ECHA Conclusions Good to know

3. REACH Regulation Basic requirements3 Background 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

4. REACH Regulation Basic requirements4 REACH Regulation REGULATION (EC) No. 1907/2006 of the European Parliamenet and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC REACH  R egistration  Evaluation  Authorisation of CHemicals

5. REACH Regulation Basic requirements5 Some starting points 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 > 10 kg pa Furthermore Many existing substances not risk assessed Call for reducing animal tests  Differences not good for internal market  not good for man and the environment

6. REACH Regulation Basic requirements6 REACH in a bookshelf I II III IV V VI VII VIII II III IV V VI VII VIII Annexes: Titles: IXXI XII XIII XIV XV XVI IX X XI XII XIII I XIV XV X XVII Technical guidance……….

7. REACH Regulation Basic requirements7 Who are the players? 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

8. REACH Regulation Basic requirements8 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

9. REACH Regulation Basic requirements9 REACH Objectives Protection of the human health and the environment Promotion of alternative methods Free circulation on the internal market Enhancing competitiveness and innovation

10. REACH Regulation Basic requirements10 REACH Core elements  Registration of substances ≥ 1 tonne/yr (staggered deadlines)  Information in the supply chain  Evaluation of some substances by Member States/ECHA  Authorisation only for substances of very high concern  Restrictions - the safety net  Agency (ECHA) to manage system

11. REACH Regulation Basic requirements11 REACH. Registration, Evaluation, Authorisation and restriction of CHemicals RestrictionsAuthorisationEvaluationRegistration CMR & PBT & equivalent concern Substances of concern > 10 tonnes/yr + substances of concern > 1 tonne/yr

12. REACH Regulation Basic requirements12 REACH Focus Priorities  high volumes (as a proxy for potential risk)  greatest concern (substances & uses with highest risk)

13. REACH Regulation Basic requirements13 No data, no market Article 5 “ Subject to Articles 6, 7, 21 and 23, substances on their own, in preparations or in articles shall not be manufactured in the Community or placed on the market unless they have been registered in accordance with the relevant provisions of this Title where this is required”

14. REACH Regulation Basic requirements14 Title II: Registration Manufacturers/Importers Registration for substances ≥ 1 tonne per year Chemical Safety Report (CSR) for all substances ≥ 10 t per year

15. REACH Regulation Basic requirements15 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 Exemptions for certain:  Substances  Uses of substances Reduced obligations  R&D, polymers and intermediates

16. REACH Regulation Basic requirements16 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

17. REACH Regulation Basic requirements17 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)

18. REACH Regulation Basic requirements18 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

19. REACH Regulation Basic requirements19 11/28/201519 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

20. REACH Regulation Basic requirements20 Registration Exceptions 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

21. REACH Regulation Basic requirements21 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.

22. REACH Regulation Basic requirements22 Reach time table Non phase-in substances 1.06. 2007 1.06. 2008 1.12. 2008 30.11. 2010 31.05. 2013 31.05. 2018 100-1000 tonnes 1-100 tonnes REACH entry into force > 1000 tonnes CMRs ( > 1 tonne) Very toxsic to aquatic organisms (R50/53) (> 100 tonnes) Pre-registration

23. REACH Regulation Basic requirements23 Substances in Articles (Article 7) 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

24. REACH Regulation Basic requirements24 Title III: Data Sharing Pre-SIEF formation Pre-SIEF formation  Industry pre-registers  ECHA makes contact details available on restricted website SIEF Formation SIEF Formation  Process led by industry Data sharing Data sharing  Process led by industry Joint submission Joint submission  Industry registers  Data sent to evaluation (ECHA, MS) Both data sharing and joint submission are obligatory!

25. REACH Regulation Basic requirements25 11/28/201525 Joint submission Joint submission Obligatory joint submission : Obligatory joint submission :  information on the hazard properties of the substance  classification and labelling Voluntary joint submission : Voluntary joint submission :  Chemical Safety Report (CSR) (for substances >10 t/a)  Guidance on safe use Individual submission: Individual submission:  Identity of manufacturer and substance  Identified uses  Exposure information (for substances in 1-10t tonnage band)

26. REACH Regulation Basic requirements26 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

27. REACH Regulation Basic requirements27 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

28. REACH Regulation Basic requirements28 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)

29. REACH Regulation Basic requirements29 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

30. REACH Regulation Basic requirements30 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

31. REACH Regulation Basic requirements31 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 list 15 substances is published http://echa.europa.eu/chem_data/candidate_list_table _en.asp ) http://echa.europa.eu/chem_data/candidate_list_table _en.asp  Priority list for inclusion into Annex XIV  Inclusion in Annex XIV (comitology decision)

32. REACH Regulation Basic requirements32 11/28/201532 SVHC: Information Requirements 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: 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 On request by consumers, suppliers must provide the consumers with the above information within 45 days  Obligation starts immediately after substance was put on the candidate list!

33. REACH Regulation Basic requirements33 Title VIII:Restriction Only minor changes compared to existing system (Directive 76/769/EEC) In addition to “marketing & use”, now also manufacturing covered

34. REACH Regulation Basic requirements34 Annex XIV substances CMR, PBT, vPvB, ‘equivalent concern’ Authorisation (also on Annex XIV) Restriction (Annex XVII) Application by M, I, or DU for limited time and scope on basis of CSR, SEA may be used Application by COM or Member State on basis of CSR and SEA Titles VII & VIII Authorisation and Restriction Substances of Very High Concern Formal procedure

35. REACH Regulation Basic requirements35 Title XI: Classification & Labelling Inventory 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

36. REACH Regulation Basic requirements36 C’RA Enforcement Authorities Competent Authorities Member States Forum Agency DGENT DGENV DGEMP DG?? Management Board C’SEA MS Committee Standing Committee National representative Experts Secretariat Manufacturers Importers Downstream users Industry Commission Council Title X : ECHA

37. REACH Regulation Basic requirements37 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

38. REACH Regulation Basic requirements38 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!

39. REACH Regulation Basic requirements39 REACH Annexes ANNEX I GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS ANNEX II GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS ANNEX III CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES ANNEX IV EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a) ANNEX V EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b) ANNEX VI INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10 ANNEX VII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE ANNEX VIII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE ANNEX IX STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE

40. REACH Regulation Basic requirements40 REACH Annexes ANNEX X STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE ANNEX XI GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X ANNEX XII GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS ANNEX XIII CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES ANNEX XIV LIST OF SUBSTANCES SUBJECT TO AUTHORISATION ANNEX XV DOSSIERS ANNEX XVI SOCIO-ECONOMIC ANALYSIS ANNEX XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES

41. REACH Regulation Basic requirements41 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 $

42. REACH Regulation Basic requirements42 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)

43. REACH Regulation Basic requirements43 Conclusions C&L Fast, transparent, open to the public Question how harmonisation between registrants will proceed Role enforcement? Authorisation & Restriction Good procedures:  1 st Annex XV  2 nd Authorisation [Annex XIV] or Restriction [Annex XVII] Authorisations  Could become very complex  Procedure could take a long time

44. REACH Regulation Basic requirements44 Conclusions Enforcement / Inspection Success REACH depends on resources (quantity and quality) at Enforcement

45. REACH Regulation Basic requirements45 11/28/201545 Where to turn for help? 1. Check the legislation (available in all EU languages) http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2006:396:SOM:EN:HTML 2. Check the Guidance website http://guidance.echa.europa.euhttp://guidance.echa.europa.eu 3. Check the Frequently Asked Questions on the ECHA website http://echa.europa.eu/reach/faq_en.asp http://echa.europa.eu/reach/faq_en.asp 4. Talk to colleagues, business associations, industry helpdesks 5. Contact national helpdesk (addresses can be found on http://echa.europa.eu/reach/helpdesk/nationalhelp_en.asp ) http://echa.europa.eu/reach/helpdesk/nationalhelp_en.asp

46. REACH Regulation Basic requirements46 Further Information http://echa.europa.eu http://ec.europa.eu/enterprise/reach/index_en.htm http://ec.europa.eu/comm/environment/chemicals/r each.htm http://ecb.jrc.it/REACH/

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