1. Intertek REACH Training, Paris January 2007 Cliff Betton, Manager PSA REACH Liliana Enache Intertek Romania Date:27.02.2009, Seminar SEETAL Registration, Evaluation and Authorisation of Chemicals Intertek

2. 2 Introduction –What is REACH? –Why REACH was necessary –Main Points of Regulation –Timeline for actions

3. 3 REACH, is simple! If you want to manufacture or import chemicals in the EU then:- –You must take responsibility for the effects –You must know what the chemicals will do To Humans To the environment –You must advise users what precautions to take –You must provide information to Regulators that the product and uses are safe and that risks are manageable –Your responsibility extends beyond sale; from manufacture to ultimate disposal.

4. 4 History 1981 - Registration of “Existing Substances” (EINECS 2XX-XXX-X) 1983 – Testing of “New” Substances (ELINCS 4XX- XXX-X) Already registered according to REACH 1993 – Submission of HEDSET data on Existing Substances 1995 – Evaluation of High Priority Existing Substances –none completed to date! 2001 – Chemicals White paper published 13 th February 2003 – First draft of REACH on October 27 th 2006 – REACH entered in force on 1st june 2007

5. 5 Examples of Past Problems Lead additives in Petrol Non degradable surfactants DDT Tributyl tin anti-fouling paints Asbestos Nonyl phenol ethoxylates

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9. 9 REACH Scope REACH is a REGULATION REACH Builds on Existing Legislation –Health –Environment –Recycling and recovery REACH Places Responsibility on the Seller –To provide information –To assess risk –Throughout the life cycle Part of a Long Term Strategy

10. 10 REACH Objectives Protection of Human Health & Environment Competitiveness of Chemical Industry Single European Market Transparency International Consistency Non-animal Testing WTO Obligations

11. 11 REACH Applies to: Substances –Single Chemicals i.e. with a CAS Number Preparations –Mixtures i.e. Consumer and Industrial products Articles –Anything where the shape or surface properties is of greater importance to the function than the chemical composition,

12. 12 Key REACH Definitions Substance Chemical element or compound in natural state or by any manufacturing process, including any additives and impurity deriving from the process used, but excluding any solvent, which may be separated without affecting stability or changing its composition  e.g. formaldehyde, DEHP, toluene, cadmium, bisphenol A, phenol, pentachlorophenol (PCP), benzidine, disperse blue 1

13. 13 Restricted and Controlled Under REACH 47 Compounds or groups of compounds e.g. –PCTs, Vinyl Chloride, Organophosphates, Benzene, Hg, As, Organotins, PCP, Ni, Nonylphenol and Nonylphenolethoxylates Specific Uses e.g. –Ornaments, Lights, Tricks & Jokes, Games –Textiles –Jewellery

14. 14 Key REACH Definitions (2) Preparation Mixture or solution composed of  2 substances  e.g. cosmetic, detergent, paint, adhesive

15. 15 Key REACH Definitions (3) Article An object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition  e.g. pen, firecracker, teething ring

16. 16 Preparation Substances Article Individual pigments, solvent chemicals, etc. Mixture of pigments & solvents Preparation put in a casing

17. 17 Key REACH Definitions (4) Substance of Very High Concern (SVHC) –CMR: Carcinogenic, mutagenic and toxic for reproduction Category 1: Substances known to be… Category 2: Substances which should be regarded as… Category 3: Substances which cause concern for man… –PBT: Persistent, Bioaccumulative and Toxic –vPvB: very Persistent and very Bioaccumulative substances –Similar substances, e.g. endocrine disrupter

18. 18 Industries Affected Most industries are affected by REACH  Chemical  Textile  Garment manufacture  Toys  Children’s articles  Electrical & Electronics  Cosmetics  Food contact  Other Consumer Products

19. 19 Intended to be released –Chemicals that are released and are intended to be so during the normal functioning of the article –Examples: Ink in a pen, toner in a copier –Each Article should be considered on a case by case basis Key REACH Definitions (5)

20. 20 Key REACH Definitions (6) European Chemicals Agency (ECHA) –Established in Helsinki –Operational in 1 June 2008 –Official Body to enforce REACH –Will set fees and process for registration –http://echa.europa.eu/home_ro.asp

21. 21 Key Elements Registration of substances > 1 ton/year Increase information and communication throughout supply chain Evaluation of some registered substances Authorisation of substances of high concern Restrictions of unacceptable substances Chemical Agency to manage the system

22. 22 REACH into force Registration of “non-phase in” substances starts (=new chemicals) Pre-registration of “existing” substances ends Registration of phase-in substances  1000 t/a; R50-53  100 t/a; CMR Cat 1&2  1 t/a Notification of phase-in substances in articles starts Registration of phase-in substances  100t/a Registration of phase-in substances  1t/a 1 Dec 2008 1June 2007 YearAction 1June 2008 1 Dec 2010 1June 2013 1June 2018 Pre-registration of “existing” or “phase-in” substances starts Note: if not pre-registered, all chemicals are considered new, thus not allowed to be sold REACH Timelines

23. 23 Responsibility for the Registration European Union Out of European Union Importer Manufacturer (substance) Distributor Downstream User Consumer Who have to register According to REACH?

24. 24 Pre-Registration Submission in Short Name and address of company Contact Person Name of substance CAS number, EINECS number Quantity Range (tonnes per year)

25. 25 Responsibility for Registration Manufacturers of Chemicals (EU) Importers –Chemicals –Preparations –Articles

26. 26 Main Retailer Needs Ensure Substances used in Products or formulations imported in the EU will be registered and Authorized for use in EU Products sold: –Articles (products like pens, printers, etc.) –Preparations (glue or clay) –Substances (pigments to prepare paints in store)

27. 27 Impact on Retailers If not a manufacturer or importer of Chemical Substance –Retailers have NO Obligation for registration under REACH Retailers sell products or formulations containing chemicals –Paints –Lubricants –Hydraulic fluids –In Products

28. 28 Retailer Obligations Principle Obligations –Implement workplace controls –Check who is importer of substance and if chemical is registered for use

29. 29 Registration of Substances in Articles Substances in articles, > 1 tonne/yr & intended to be released also require Registration Articles with substances as CMR Cat 1,2, PBT, vPvB, or endocrine disrupters >0.1% & >1 tonne/yr require Notification to European Chemicals Agency Exempted for substances with excluded exposure to human & environment

30. 30 Substances in Articles Substances in articles, > 1 tonne/yr & intended to be released also require Registration Articles with substances as CMR Cat 1,2, PBT, vPvB, or endocrine disrupters >0.1% & >1 tonne/yr require Notification to European Chemicals Agency Exempted for substances with excluded exposure to human & environment

31. 31 Notification Information Identification (registrant & substance) Manufacture & use Classification and labelling Description of use (substance & article) Registration number (if available) Tonnage range

32. 32 Time Frame - Notification Required by 1 December 2010 An article may need both Registration and Notification

33. 33 European Chemicals Agency (ECA) Day to day management of REACH –Technical, scientific and administrative aspects Responsibilities: –Registration – reject or require completion of registration –Evaluation – ensure a harmonised approach; take decisions –Authorisation/restrictions – facilitate process; suggest priorities –Secretariat for Forum and Committees –Deal with appeals – registration, R&D, evaluation, confidentiality Location: Helsinki

34. 34 Start Prepare for REACH What chemicals are used in products? Where are they used in processes? What information is available about these chemicals? Are all chemicals going to be Registered? Are there SVHC? Is the above information stored in a central location and easily retrievable? Is there a REACH Management System in place?

35. 35 FAQ

36. 36 Question #1 Is it possible that REACH will not get through? Answer #1 No! REACH became Law on 30/12/2006 and will be implemented on 1 st June 2007 –EU puts in huge resources in preparation for REACH including guidance documents, software & IT –China had already translated the last draft of REACH into Chinese

37. 37 Question #2 How to calculate the volume of a chemical in a downstream product? Answer #2 Calculate substance contained in a chemical preparation by proportion For article, information from upstream of supply chain is required One tonne threshold is only one of the conditions for registration or notification

38. 38 REACH Requirements Summary PreparationsSubstances in Articles Intended to be Released Substances in Articles Released NOT Intended e.g. Glue, painte.g. Pen containing inke.g. Clothing, iron, hair dryer Registration if substances imported > 1 tonne/yr Collect chemical info and/or SDS Pre-register & participate in SIEF Check presence of SVHC Perform necessary testing Forward information to customer if SVHC > 0.1% Submit Technical Dossier & CSR if > 10 tonnes Notification if SVHC > 0.1% & > 1 tonne/yr Monitor change in SVHC list & Authorisation

39. 39 Intertek Capabilities 1)REACH Article Impact Assessment 2)Develop a REACH Management Process 3)Develop REACH Management Systems and REACH Action Plans Gap analysis and system development 4)Auditing of REACH Management Process 5)REACH Consulting

40. 40 Contact Us E-mail: reach@intertek.com Local.contact@intertek.com

41. 41 THANK YOU, for your attention!