Registration, Evaluation, Authorisation and Restriction of Chemicals Regulations REACH

1. Registration, Evaluation, Authorisation and Restriction of Chemicals RegulationsREACH Cathy Phillips CEng IMechE CMIOSH AIEMA HSE Materials Manager, Corporate HSE

2. Rolls-Royce plc • Power for air, sea and land • Customers; 500+ airlines, 4,000 corporate and utility aircraft and helicopter operators, 160 armed forces and more than 2,000 marine customers, including 50 navies. Energy customers in nearly 120 countries. • Annual sales over $10 billion • 35,000 employees; 21,000 in UK, 8,000 in North America and 5,000 in rest of Europe Filename

3. REACH and YOU • Overview of REACH • Legal obligation 1 – pre-registration through to authorisation • Pre-registration • Registration • Authorisation & restriction • Legal obligation 2 - Declaration • Business Risk • Action Plan / Governance Filename

4. Objective To identify the business and legal risks associated with REACH. To assess the overall scale of the task for each of your legal entities. Filename

5. Business Risks and REACH REACH could result in some of the substances used to make manufactured products being: • Unavailable, if suppliers (manufacturers / importers) do not register the substances. • Increasingly difficult to obtain in the long term, if they are hazardous. • More costly to buy (because of the registration and authorisation costs). Filename

6. Importation ManufacturePlacing on the market Use Importation On their own In preparations In articles Trichlorethylene Paints, Sealants, Resins Systems, Components, aircraft REACH scope of substances Filename

7. REACH Key Words • Substance: A basic chemical, like iron, nickel, trichloroethylene, lead oxide • Preparation: A mixture of chemicals, like steel, adhesive, resin, paint, an etchant, an NDT fluid • Article: An object where the shape is more important than its chemical composition: A billet, a rod, a diesel engine, a gasket, a spare part, a submarine, a valve, a second hand product Filename

8. Who does REACH apply to? • Any Company (LEGAL ENTITY) producing, importing, using or placing a substance, preparation or article on the EU market must comply with REACH. • Covers EU manufacturers, including chemical suppliers, distributors and downstream users. • Covers EU enterprises importing products to the European Community Filename

9. Supply Chain and manufacturing use of Substances Authorisation to use in specific application Pre-registration Import substances into EU >1tonne/year Registration Pre Registrants to submit Safety Assessment for each specific use of substance Evaluation By ECHA. For several substances this may already exist Restriction Substances of very High Concern (Candidate list) Declaring Substances of Very High Concern in Articles to customers Supplier Rolls-Royce Customer 0.1% of SVHCs In Articles 0.1% of SVHCs In Articles REACH – legal overview Filename

10. Supply chain communication Filename

11. Supply Chain and manufacturing use of Substances Authorisation to use in specific application Pre-registration Import substances into EU >1tonne/year Registration Pre Registrants to submit Safety Assessment for each specific use of substance Evaluation By ECHA. For several substances this may already exist Restriction REACH – legal overview Filename

12. Pre-Registration in REACH • Manufacturers and IMPORTERS(M/I) of substances have to register them. • This will MAINLY be chemical manufacturers and suppliers. • Many substances can benefit from an 11 year phase in of registration, if they are Pre-registered BETWEEN JUNE AND END NOV. Filename

13. Continuity of supply: Will your suppliers (particularly distributors and stockists who are importers) meet their legal obligations? Continued legal use: Will the manufacturer or importer (who could be several tiers up), include your use in their registration? Implications of Registration on Downstream Users… Filename

14. Title IV - Information in the Supply Chain Safety Data Sheets inversion of Sections 2&3 + email contact Persistent, Bioaccumulative and Toxic substances (PBT) and very persistent / very bioaccumulative substances (VPVB) will NOT be shown (initially) Will require an “extended SDS” following registration (e-SDS) which will MANDATE the way in which the substance / preparation is used. Filename

15. Title V - Downstream Users DUs need to: communicate use upstream (min 12 months prior to phase-in registration deadline) distributors have responsibility to pass information up and down between DUs and manufacturers / importers DU Chemical Safety Assessment for uses outside an Exposure Scenario (or use & exposure category) DU exceptions (e.g. <1 tonne per year) General compliance (max 12 months) Reporting of information (max 6 months) Filename

16. The Evaluation in REACH • Once pre-registered, manufacturers and importers of substances have to prepare DOSSIERS that will be EVALUATED by the REACH Agency in Helsinki. • This will decide whether registered substances are ‘nasties’(substances of very high concern). If they are, then the European Commission could require them to go through Authorisation or Restriction. Filename

17. Supply Chain and manufacturing use of Substances Authorisation to use in specific application Pre-registration Import substances into EU >1tonne/year Registration Pre Registrants to submit Safety Assessment for each specific use of substance Evaluation By ECHA. For several substances this may already exist Restriction Substances of very High Concern (Candidate list) REACH – legal overview Filename

18. “Substances of Very High Concern” • Carcinogens, mutagens and reproductive toxins (CMRs) • Persistent, Biocumulative and Toxic (PBT) • Very persistent and very bioaccumulative (vPvB) • Substances of equivalent concern (endocrine disruptors) Filename

19. The Declarable Substances list • This list is intended to: • Help companies make product and process decisions, whilst complying with regulatory and customer requirements. • Enable the business risk from these substances to be managed throughout a supply chain • It is intended primarily for the aerospace defence sector http://www.asd-stan.org TR 9535 and TR 9536 Filename

20. Declarable Substances SAE standard Candidate List AnnexeXIV Relevant to YOUR business Substances in our Products and Processes All substances Filename

21. The Declarable Substances list • A compilation of all the substances that have been identified as being… • CMRs category 1& 2 (annex 1 of directive 67-548 as amended) • Substances defined as vPvB or PBT (OSPAR listed substances) • Ozone Depleting Substances as defined by Montreal Protocol • Persistent Organic Pollutants as defined by the Stockholm Convention, etc. • Substances listed within Annex XVII (restricted substances) Filename

22. Declarable Substances SAE standard Candidate List AnnexeXIV High Risk Marine relevant Substances in our Products and Processes All substances Declaration from supply chain by no later than end 2010? Declaration from supply chain asap Filename

23. Supply Chain and manufacturing use of Substances Authorisation to use in specific application Pre-registration Import substances into EU >1tonne/year Registration Pre Registrants to submit Safety Assessment for each specific use of substance Evaluation By ECHA. For several substances this may already exist Restriction Substances of very High Concern (Candidate list) Declaring Substances of Very High Concern in Articles to customers Supplier Rolls-Royce Customer 0.1% of SVHCs In Articles 0.1% of SVHCs In Articles REACH – legal overview Filename

24. Articles Registration = if intended release Notification = if ‘Candidate List’ & >0.1% w/w & cannot excluded exposure unless already registered for that use Filename

25. Requirement to Inform Customers and the Consumer • You have a legal obligation to INFORM Customers about SVHCs contained within YOUR product (Article 33(1)) • > 0.1% w/w • “sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance”. • Same information to be available free of charge to consumers on request (within 45 days) • Your suppliers also have this obligation if they are located in the EU. Filename

26. Requirement to Notify of SVHCs You have a legal obligation to NOTIFY the REACH Agency (ECHA) AND Customers about SVHCs contained within YOUR product (REACH Article 7(2)) if the following apply: • >0.1% w/w AND • > 1 tonne sold (of SVHC per year) AND • Cannot show that the substance will not be released at any point in the life cycle (including disposal) This is a subset of the information needed for the customer Filename

27. REACH and business risk… Filename

28. Issues within the Supply Chain Filename

29. Issues within the Supply Chain Filename

30. Issues within the Supply Chain Filename

31. ACTIONS: Hold your own internal workshops: • Dealing with the Registration process: • Manufacturer, importer or downstream user? • What do you buy from where? • What action is needed prepare for preregistration/registration? • What are the SVHCs used in your factories? • Dealing with the “Declaration” part of REACH: • What are the declarable substances (as a surrogate for SVHCs) in your products? • What are the risks from REACH to you? • Continuity of supply? • Ability to adapt to the loss of substances? Filename

32. Step 1: What are YOUR responsibilities in REACH? • What substances / preparations do you use? • Which of these are imported? • Find out if what you are buying is imported by YOUR company or someone else. • If it is YOU, ask the non-EU supplier if they intend to have an ‘only representative’. YOU have a legal obligation to pre-register if you import! YOU NEED TO ACT NOW! Filename

33. Step 2: Engagement with Suppliers • If you want to maintain access to chemicals & raw materials, it is vital that the supplier understands their responsibilities. DEFRA estimates that more than 60% of businesses have not even heard of REACH. What should you do about it? • Most of your supply chain is probably unaware about REACH. So TELL THEM. • Are they organised for REACH?: Check! • EXAMPLE LETTERS ARE AVAILABLE • Will your supplier take care of you?: ASK! Filename

34. Step 2: Engagement with Suppliers ACTION: Have the suppliers you deal with heard of REACH? • Compile a list of your suppliers, and where they are. Include addresses. • Write to all your suppliers telling them about REACH. • Ask each supplier who their REACH FOCAL POINT is. • Keep a record on who has replied, and the names / email addresses of the focal points. ANSWERS WILL BE:  “Don’t worry, we will pre-register/register”.- You are OK!  “We will not be registering”- You need to change supplier / product!  “Silence”: we don’t know what you are talking about - You need to educate your supplier! Filename

35. Step 2: Engagement with Suppliers  Dealing with “silence”! • Recommend that your suppliers go on a training day on REACH. • Most sectors offer training on REACH – they should go on one relevant to them. • EEF, • HSE, • British Coatings Federation, • Institute of Metal Finishing etc. Filename

36. Step 3: Estimate the risk EU stockists / distributors / agents… • Most distributors and stockists who are importers ARE UNAWARE OF THEIR OBLIGATIONS (according to UK HSE & DEFRA). • Many smaller stockists intend to stop supplying, because of the costs!! • Will this be the case for your supply chain? • What is the threat to your continuity of supply? Filename

37. Step 3: Estimate the risk EU manufacturers of substances, formulators of preparations… • If the substance is a small sales stream for them, it may not be cost effective for them to keep making it. • Does this affect any substances, or constituents in preparations, that you need? • Will formulators change the ingredients in the preparations they sell you (do you care?) • What is the threat to your continuity of supply? Filename

38. Step 4: Record what you learn For substances & preparations, make a spreadsheet of… • The tradenames / specs of the chemicals you buy • Where and who you buy them from (import?) • How much you buy • Whether the supplier knows about REACH • Who their focal point is • Their contact details • Whether we are the importer • If there is an only representative • To prove ‘due diligence’ to regulators • To help senior managers make decisions! Filename

39. Step 5: Up to date COSHH inventories • CHECK that all substances / preparations you buy are supplied with a MSDS, and check that it goes to your HSE people. • Are there people outside purchasing that have delegated authority to purchase substances and preparations? • How do you ensure these people get the MSDS to the HSE team? • Tighten up these processes! Filename

40. Step 6: SVHCs • Your company needs to be able to tell customers and ECHA about all SVHCs within the products you make. • To do this, you need the information for all products you BUY, where they are… • PREPARATIONS that we incorporate into the product • ARTICLES that we incorporate into the product • In the absence of any other list, you can use the ‘declarable substances list’ from the SAE standard. • Watch for the issue of the first ‘candidate list’! Filename

41. Step 7: Authorisation • From next year, your company will need an ‘authorisation’ for continued use of SVHCs put onto the candidate list and transferred onto ANNEX XIV of REACH. • 50,000 Euros per authorisation per use • Paperwork (Like COMAH) for the application process • The need for this will be stated on the MSDS. • For these substances, substitution plans are mandatory. • Start planning for these changes Filename

42. Other sources of guidance and advice • http://www.reachready.co.uk • General Manufacturing Industry: • http://www.orgalime.org/publications/guides/reach.htm • Aviation/Automotive Industry: • http://www.asd-europe.org/Content/Default.asp?PageID=41 • http://www.sbac.co.uk/community/cms/content/preview/news_item_view.asp?i=17018&t=0 • Chemicals Industry: • http://www.reachcentrum.org/ • Coatings Industry: Filename http://www.coatings.org.uk and search on OutREACH

43. Official sources of guidance and advice • ECHA WEBSITE: • http://ec.europa.eu/echa/home_en.html • European Commission: • http://ecb.jrc.it/reach/ • DEFRA: • http://www.defra.gov.uk/corporate/consult/reach-enforce/index.htm • HSE: THE UK ‘Competent Authority’: • 0845 408 9575 • UKREACHCA@hse.gsi.gov.uk Filename