The REACH Regulation Workshop CIQyP Argentina Buenos Aires, 16 May 2007 – Cristina Arregui

1. The REACH Regulation Workshop CIQyP Argentina Buenos Aires, 16 May 2007 – Cristina Arregui

2. The REACH System • On 30 December 2006 a New Chemicals Regulation, called "REACH“ has been published in the Official Journal of the European Union. • REACH stands for the Registration, Evaluation and Authorisations of Chemicals • The Proposed REACH Regulation will replace most of the EU chemicals legislation in place and create a European Chemicals Agency • It will have an impact on all companies producing, importing and using

3. Content • Forces that led to this new legislation • Build-up of REACH legislation • REACH at a glance

4. C&L Classification & Labeling CMR Carcinogenic, Mutagenic, Toxic for Reproduction CSA Chemical Safety Assessment CSR Chemical Safety Report DNELs Derived No-Effect Levels DSD Dangerous Substances Directive DU Downstream User EU European Union ES Exposure Scenario GHS Global Harmonized System (for C&L) M/I Manufacturer / Importer PBT Persistent, Bioaccumulative and Toxic substance PNEC Predicted No-Effect Concentration PPORD Product and Process oriented Research & Development QSAR Qualitative or Quantitative structure-activity relationship RIP REACH Implementation Project RMM Risk Management Measure SDS Safety Data Sheet SIEF Substance Information Exchange Fora SVHC Substances of Very High Concern VAS Vertebrate Animal Study vPvB very Persistent and very Bioaccumulative substance Terminology

5. Content • Forces that led to this new legislation

6. Towards the REACH System Registration of existing substances Notification of new substances 79/83/EEC - 6th Amendment to 67/548/EC 92/32/EEC - 7th Amendmentto 67/548/EC EU Chemicals Policy Review 65. . .70. . .75. . .80. . . 85. . . 90. . . 95. . . 00. . . 05 . . . 10 Hazard assessment: 67/548/EEC Classification, packaging & labelling of Dangerous Substances Risk assessment: 93/67EEC (new subst) Reg 793/93 (existing subst) Restriction on Marketing and Use: 76/769/EEC

7. The EU Chemicals Policy Review • In April 1998, the failure of the Existing Substances Regulation caused the European Environment Council to launch the Chemicals Policy Review (CPR) • The Council called on the Commission to: «develop a new, integrated and coherent chemicals policy adequately reflecting the precautionary principle and the principle of sustainability and specifying the obligations incumbent on the parties involved»

8. Increase transparency Political Objectives of REACH Maintenance and enhancement of chemical industry competitiveness Prevent fragmentation of internal market Integration with international efforts Promotion of non-animal testing Protection of human health and environment Conformity with EU international obligations under the WTO DG ENTR DG ENV

9. Content • Build-up of REACH legislation

10. The REACH Regulation • Regulation (EC) No 1907/2006 of the European Parliament and the Council of 18 Dec 2006 concerning the registration Evaluation, Authorisation and Restrictions of Chemicals (REACH) http://eur-lex.europa.eu/LexUriServ/site/en/oj/2006/l_396/l_39620061230en00010849.pdf

11. The REACH Regulation • REACH is substance related • REACH lays responsibility with producers of substances • Hazards • Risk identifications • Risk Management Measures

12. REACH Regulation - Content

13. REACH Titles • Title I: General issues • Title II: Registration of substances • Title III: Data sharing and avoidance of unnecessary testing • Title IV: Information in the supply chain • Title V: Downstream users • Title IV: Evaluation • Title VI: Authorisation • Title VIII: Restrictions on the manufacturing, placing on the market and use of certain dangerous substances and preparations • Title IX: Fees and charges • Title X: Agency • Title XI: Classification and labelling inventory • Title XII: Information • Title XIII: Competent authorities • Title XIV: Enforcement • Title XV: Transitional and final provisions

14. Main Steps in REACH A single system for non-phase-in (new) and phase-in (existing) substances • Pre-Registration: data sharing and avoidance of unnecessary testing • Registration of substances of 1 ton or more per M/I/year • Information in the supply chain; downstream users • Evaluation of dossiers by Agency and Member States • Authorisation for substances of very high concern • Restrictions – the safety net The Agency to manage the system

15. European Chemicals Agency • Located in Helsinki • Operational 1 year after REACH entries into force • Main responsibilities: • (Pre-)registration • Evaluation • Authorisation • Helpdesk • REACH IT and IUCLID 5

16. REACH - challenges The challenge for chemical industry • assess (including data generation) • document (Chemical Safety Report) • register (together with other producers and downstream users) • communicate (via Safety Data Sheet) • 30.000 substances in 11 years!

17. REACH Implementation Projects - RIPs • AIM:To develop in close collaboration with all stakeholders guidance helping to fulfil the obligations under REACH • RIP 1: REACH Process Description; • RIP 2: REACH – IT; • RIP 3: Technical Guidance and Tools for Industry; • RIP 4: Technical Guidance and Tools for Authorities; • RIP 5 & 6: Setting up the Agency • RIP 7: Preparation of the new tasks for the Commission • More info:http://ecb.jrc.it/REACH/

18. RIP 3 subprojects • RIP 3.1: Preparing Technical dossier • RIP 3.2: Preparing CSA/CSR • RIP 3.3: Information requirements • RIP 3.4: Data sharing • RIP 3.5: Down Stream User requirements • RIP 3.6: C&L and GHS • RIP 3.7: Application dossier • RIP3.8: Requirements for articles • RIP 3.9: Socio-Economic analyses • RIP 3.10: Substance identity

19. Content • REACH at a glance • General issues • Registration and Data Sharing • Information in the SC and Downstream users • Evaluation • Authorisation • Other Titles

20. REACH at a glance • Title I General Issues • Structure of REACH • Roles in REACH • Scope of REACH

21. The Structure of the REACH Processes All substances Substances of very high concern Substances > 1 ton Substances placed on the market Restriction Registration C& L of CMR C& L Inventory Authorization Evaluation

22. Roles in REACH • Manufacturer/Importer: • should (pre)register substances Produced/Imported by him • Should do CSA/CSR for substance • RMM for intended use, extended SDS (include ESs) • Communicate down stream supply chain • Downstream User: • Should communicate intended use to M/I • Should follow advise SDS and apply advised RMM • In case of non-identified use (>1t/a): CSR and inform Agency

23. Roles in REACH • Distributor: • Downstream communication on ESs and RMM • Upstream information on usage and identified use for registration • Only representative: • Importer may appoint only representative to fulfil his requirements • EU based • Third party representative: • M/I appoint to represent in certain activities • To protect confidentiality and CBI

24. The Scope of REACH • REACH covers: • Manufacture, import, placing on the market and use of substances • Substances “on their own”, in preparations or in articles • General exemption from scope: radioactive substances, substances to custom supervision, non-isolated intermediates • Several exemptions from the REACH requirements. Different at Registration, Authorization, Restrictions 30,000 substances

25. REACH at a glance • Title II Registration • Title III Data sharing

26. Registration – Title II What do I have to register? • All substances manufactured or imported >1 ton/producer/year • Exemptions • Reduced requirements • Deemed to be registered

27. Manufacturer • Importer • EU Representative of non-EU manufacturer Deemed to be Registered more than 1 t/yr Obligation to register Exemptions for • Substances to the extent they are used for a specific use covered by other legislation (art. 2) • Polymers • Well known substance (Annex IVI) • Inappropriate (Annex V) • COM reviews Annex IV and V within one year after entry into force • PPORD (time limited) • Re-importation • Registered substances being recovered in the Community General : Full Dossier Special : Reduced Dossier • Substances on its own or in preparation • Monomers, even if intermediates • Substances in articles (conditions apply) • Isolated intermediates • on-site(under strictly controlled conditions) • transported(confirmation from user that use takes place under strictly controlled conditions) • Notified substances(67/548/EEC) • Substances in plant protection and biocidal products (art. 15)

28. Data sharing and avoidance of unnecessary testing - Title III Potential registrants to share studies before registration - How? • Non phase-in substances: Send a enquiry to the Agency with specific information • Phase in substances: Duty to Pre-register – send specific information to the Agency to join a SIEF • Summaries submitted more > 12 years freely available

29. Pre-registration information Pre-registration phase: 12 – 18 months after REACH entries into force • Name and address of the producer (or third party) • Substance name & EINECs and CAS n° (if available) • Substance name (as previously) for where either (Q)SARs are available or read-across is applicable. • The envisaged deadline for the registration/tonnage band

30. SIEF for Phase-in Substances • Aim: exchange information to minimise duplication of tests and to agree on classification and labelling • SIEF participants provide others with existing studies, react to requests by others, identify needs for further studies and arrange to carry them out • Sharing of tests involving vertebrate animals mandatory • if participant refuses to share => stop proceeding registration and sanctions • rest of SIEF proceeds without fulfilling this requirement • Sharing of tests involving non vertebrate animals and phys-chem data obligatory at request of another potential registrant

31. 1000 t/y CMR 1&2 R50-53 >100 t/y Pre-registration & Registration timetable for phase - in substances 1 June 2007: REACH entries into force 1 Jun 2018 Pre-registration 18 months All substances 1 Jun 2008 1 Dec 2008 1 Jun 2013 1 Dec 2010 2,5 years 5 years 3,5 years Registration Registration Registration 100 - 1000 t/y 1 - 100 t/y 11 years 3,5 years 6 years

32. Registration – Title II Which information?

33. Information Requirements What should include the Technical Dossier? • Identity of manufacturer or importer, identity of substance • Information about manufacturing process and produced quantity incl. all identified use(s) • Classification and labelling • Guidance on safe use (storage, disposal, first aid measures) • All relevant and available test data (incl. a literature search) but as a minimum summaries and “robust study summaries” of test data (Annex VII-X) • Proposal for additional tests • Exposure information for 1-10 tonnes • Indication as to which information has been reviewed by an independent assessor • Request for confidentiality in accordance to art. 118 (2)

34. Information Requirements Registration Annexes Annex VII • Physicochemical properties • Basic human health data • Short term aquatic toxicity Annex VIII • Human health data (including in vivo) • Ecotoxicological data Annex IX and Annex X • Long term, repeat dose, chronic, fate etc Annex XI • Adaptations of the testing regimes (exposure waiving, read-across, QSARs, )

35. Information Requirements What is the Chemical Safety ssessment/Report? • Shall consider all stages of the life-cycle of a substance as defined by the identified uses and will contain the following information: 1. Human health hazard assessment • 2. Human health hazard assessment of physico-chemical properties • 3. Environmental hazard assessment • 4. PBT and vPvB assessment • - - - - if dangerous or a PBT or vPvB - - - - • 5. Exposure assessment • 6. Risk characterization • CSR rules defined in Annex I

36. Joint submission of data between multiple registrants S E P A R A T E L Y C H O I C E JOINT Identification of manufacturer or importer Identification of substance Information on manufacture and use For substances 1 to 10 t, exposure information (section 6 of Annex VI) Indication about review by an assessor Guidance on safe use (section 5 of Annex VI) Chemical Safety Report Classification and labelling Study summaries and robust study summaries of information derived from application of Annexes VII to XI Proposals for testing where listed in Annexes IX and X Indications about review by an assessor

37. REACH at a glance • Title IV Information in the supply chain • Title V Downstream users

38. Information in the supply chain Downstream Users - Title IV & V • Duty to communicate information in the supply chain • Through Safety data Sheet for classified substances and PBTs / vPvB • Specific information when no SDS is required • Downstream users have also duties! • Downstream users must prepare a CSR for a use outside the conditions described in an exposure scenario communicated to him in a SDS

39. 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 • Limited work for DUs • If using suppliers CSR, DUs just have to implement supplier’s RRM for identified uses • Otherwise DUs generally [ exemptions!] perform assessments for ‘unidentified uses’ (using supplier’s hazard information) and inform Agency of such uses ≥ 1 tonne

40. REACH and the supply chain Manufacturer / Importer European Chemicals Agency Registration: > 1t and inside scope Substance on its own, in preparation or article depending on: • classification and labelling Technical Dossier > 1 t CSR > 10 t Exposure Assessment and risk characterisation >10 t and dangerous or PBT or vPvB SDS dangerous or PBT or vPvB Exposure Scenario(s) >10 t Specific conditions - waiving Use outside exposure scenario > 1 t complete CSR Downstream Users Report if > 1 t

41. REACH at a glance • Title VI Evaluation

42. Evaluation – Title VI Substances will be evaluated by the Agency and Member States - What will they evaluate? • Dossier evaluation – done by the Agency • Examination of testing proposals: to prevent unnecessary animal testing, i.e. the repetition of existing tests, and poor quality tests • Compliance Check: the Agency may check the compliance of registration dossiers to check if they comply with the registration requirements. At least 5% of dossiers should be checked; • Substance evaluation – done by MSs • if it is suspected that a substance presents a risk and further data is needed; Community rolling action plan

43. REACH at a glance • Title VII Authorisation

44. The Authorization Process • REACH requires the pre-market approval (Authorization) of «Substances of Very High Concern» (SVHC), selected on the basis of their hazardous properties • The Authorization decision is taken by the Commission on the basis of risk and socio-economic assessments, taking into account available suitable alternatives • The Authorization is use-specific, company-specific and will be subject to revsion on a case by case basis • The Authorization Process consists of 3 phases: • Selection  Prioritization  Authorization (or “ban”)

45. Scope of the Authorization Process • Authorization applies to each manufacturer/ importer or downstream user who markets a substance (as such, in preparations, or articles) listed in Annex XIV for use or uses it himself • No volume threshold • No polymer exemption • A series of exemptions for some regulated products (e.g. Food-contact materials and cosmetics are exempted from the human health assessment part of the process)

46. Authorisation - Title VII SVHC need to be authorised before placing them in the market Which substances? • Carcinogenic cat. 1&2 • Mutagenic cat. 1&2 • Reprotoxic cat. 1&2 • Persistant, Bioacumulative and Toxic – PBTs (Annex XIII Criteria). • Very Persistant, Very Bioacumulative – vPvBs (Annex XII Criteria) • identified from scientific evidence as causing probable serious effects to humans or the environment equivalent to those above on a case-by-case basis, such as endocrine disrupters or other PBTs/vPvBs CMRs 1&2

47. Authorisation of SVHC What do I have to do to apply for an authorisation? • Application to the Agency to include: • the identity of the substance(s) and name/contact of the M/I • which use(s) the authorisation is sought • CSR, unless already submitted as part of the registration; • an analysis of the alternatives considering their risks and the technical and economic feasibility of substitution, and including information about any relevant research and development activities by the applicant, if appropriate; • where the analysis referred to in paragraph (e) shows that suitable alternatives are available, a substitution plan including a timetable for proposed actions by the applicant • Agency Committees opinions, open for comments • Commission decision on the Authorisation (Comitology)

48. Authorisation process: granting In which cases I will get an authorisation and for how long? • Granting of authorisation • if the risks are adequately controlled except for: • PBTs & vPvBs according to Annex XIII • Substances of equivalent concern having PBTs & vPvBs properties • Other substances for which it is not possible to determine a threshold (Annex I, section 6.4), • if the socio-economic benefits outweigh the risk and if there are no suitable alternative substances or technologies. • Duration: time limited review on a case by case basis based on all relevant information including the following elements: • The risk posed by the substance including RRM and SE benefits • Analysis of alternatives or substitution plan submitted

49. REACH at a glance • Other Titles

50. Other Titles • Title VIII Restrictions • Title IX Fees and Charges • Title X Agency • Title XI Classification and Labelling inventory • Title XII Information • Title XIII Competent Authorities • Title XIV Enforcement • Title XV Transitional and Final provisions