REACH R egistration E valuation A uthorisation of CH emicals

1. REACHRegistration Evaluation Authorisation of CHemicals Michael J. Hynes Department of Chemistry National University of Ireland Galway ICF Technical Exchange Conference

2. The EU Approach ! • EU Legislators “have a predisposition to legislative action” even when no problem exists. • An ombudsman needed to screen all new proposals to prevent laws being passed that were simply “solutions in search of problems”. • Much of the EU legislation is “paper proposals” that does not offer benefits. • Michael McDowall (Irish Minister for Justice) ICF Technical Exchange Conference

3. Outline of presentation • REACH key elements • Claimed benefits • Glass • Appendix 1 synopsis (my ICF submission) • Conclusions ICF Technical Exchange Conference

4. What does REACH regulate ? • The manufacture, import, marketing and use of chemicals. • Need to REGISTER each chemical produced or imported at more than 1 tonne per year. • Member states will EVALUATE the information provided in the registration phase. • Substances of high concern will be subject to AUTHORISATION. (Sunset date) • Substances that cause • Cancer, genetic mutations or birth defects (CMRs) as well as substances that are persistent, bioaccumulative and toxic (PBT & vPvB) ICF Technical Exchange Conference

5. Exemptions under REACH • Pharmaceuticals, pesticides, radioactive materials (regulated under other laws). • Substances in transit through Europe. • Non-isolated intermediates. • Substances formed as byproducts or that result from incidental reaction (sunlight). • A variety of substance e.g. oils, fatty acids, natural gas, crude oil and coal. • Minerals, ores or substances occurring in nature are exempt if they are not chemically modified during their manufacture and are not dangerous. ICF Technical Exchange Conference

6. What does REACH cover ? • REACH deals with SUBSTANCES ONLY and not preparations or articles. ICF Technical Exchange Conference

7. Definitions – Substance, Preparation • Anything we call a chemical in ordinary conversation is a substance or a preparation under REACH. • Substance – a single chemical (an element and its compounds either natural or manufactured. • Carbon is a substance (an element) • Calcium Carbonate is a substance because it is a single compound. • Preparation – a mixture or solution containing two or more substances. • Paint is a preparation. ICF Technical Exchange Conference

8. ARTICLE • Any object produced by industry that is not a substance or a preparation is an article. • Anything that has been given a specific shape, surface or design during production, so that it can be used for a specific purpose. • Computers, books, toys, cars are all articles. • Some of the chemicals in an article may be harmful to environment and health. • If such a substance is released intentionally as part of the function of the article, it will need to be registered • e.g. ink in print cartridge ICF Technical Exchange Conference

9. Downstream User • A company that buys chemicals and uses them in a product. • Most manufacturers and formulators are downstream users. • Hairdressers are downstream users. • Crystal glass manufacturers are downstream users of chemicals. ICF Technical Exchange Conference

10. The REACH System Authorisation of CHemicals Registration Evaluation Manufacturers, Importers and Downstream Users within the EU are subject to REACH Crystal glass industry is a downstream user – REACH applies ICF Technical Exchange Conference

11. The REACH System – Main Goals • Improved knowledge about the (hazardous) properties of substances on the European Market • Polluter-Pays-Principle • Contribution to innovation • Equal treatment of New Substances and Existing Substances • Transparency along the whole supply-chain • Consumer Protection ICF Technical Exchange Conference

12. Aims of White Paper of June 2001 • Protection of human health and the environment. • Maintenance and enhancement of the competitiveness of the EU chemical industry. • Prevention of fragmentation of the internal market. • Increased transparency. • Integration with international efforts. • Promotion of non-animal testing. • Conformity with EU international obligations under the WTO. ICF Technical Exchange Conference

13. How Does REACH Work Substance (Chemical) No Yes Extremely Hazardous*? INTRINSIC PROPERTIES Authorisation 1 t/year > 100 t/year Evaluation TONNAGE BANDS Registration * CMR, Carcinogen, Mutagen, Reproductive Toxicant ICF Technical Exchange Conference

14. REACH is based on quantity • REACH should be based on risk • Intrinsic hazard not a good measure of risk • Risk is a better measure as it is based on the likelihood that an intrinsic hazard associated with a substance will cause actual harm. • While REACH replaces up to 40 Directives and Regulations, it leaves more than 20 others in place. • REACH should only require data that is of real value. • The ‘best’ and ‘safest’ chemicals should not be withdrawn simply because they generate insufficient profit to cover the cost of testing. ICF Technical Exchange Conference

15. Is REACH Necessary ? • Depends on your point of view !! • Problem of existing substances on market before September 1981 (EINECS) • EINECS lists about 100,204substances when it was compiled (Substances on EU market between January 1971 and 18 September 1981) • Little Risk Assessment done on these • 30,000 substances on market above 1 tonne/pa • Have an unfair advantage in the marketplace • No impetus to replace them • Only the 30,000 need to be Registered • Council Regulation 793/93/EEC really did not work. • Small number of substances risk assessed. ICF Technical Exchange Conference

16. Withdrawal of Chemicals from Use • REACH is expected to result in some withdrawal of chemicals from the market. • Estimates for this vary widely • the Commission has given estimates of 8-12 percent of chemicals from production or use. • Withdrawal of a chemical can have very serious repercussions. ICF Technical Exchange Conference

17. But lots of existing legislation • Up to now now, Directive 67/548/EEC has been amended nine times, the ninth amendment being Directive 1999/33/EC and adapted to technical progress (ATP) twenty eight times, the 28th being Directive 2001/59/EC. • 76/769/EEC of 17th July 1976 [4] on restrictions of the marketing and use of chemicals (the so-called Limitations Directive) which is used to restrict or prohibit the marketing and use of certain chemicals which cause unacceptable risk to human health or the environment • Biocides directive 98/8/EC • which has sounded the death knell for the Irish wake • prospect of a ban on formaldehyde used to embalm bodies. • The cost of evaluating formaldehyde, estimated to be €6 million will prove uneconomic for a relatively small industry manufacturing formaldehyde. ICF Technical Exchange Conference

18. Integrated Pollution Prevention and Control • While some member states had implemented a system of Integrated Pollution Prevention and Control (IPPC) prior to its implementation, Directive 96/61/EC made this mandatory. • The concept of best available technology (BAT) was introduced. • The original IPPC directive has been amended twice. • The first amendment reinforced public participation in line with the Aarhus Convention while the second clarified the relationship between the permit conditions established in accordance with the IPPC Directive and the EU greenhouse emission trading scheme. • The Commission is currently carrying out a review of the IPPC Directive and related legislation on industrial emissions, over the period 2006-2007. ICF Technical Exchange Conference

19. National Authorities • The National Authorities in the member states have in many instances enacted additional legislation regulating the use of chemicals in the workplace in the form of Safety, Health and Welfare at Work legislation and the subsequent sale or disposal of chemicals. • Furthermore, industries using chemicals are continually being monitored by pressure groups such as Greenpeace, Friends of the Earth and the World Wildlife Fund (WWF). ICF Technical Exchange Conference

20. International Programme on Chemical Safety • International Programme on Chemical Safety (IPCS) established in 1980 is a joint programme of three reputable cooperating organisations • World Health Organisation (WHO) • International Labour Office (ILO) • United Nations Environment Programme (UNEP). • Has a very comprehensive library of methods for chemical assessment. • In order to utilise the best use of limited resources, the IPCS in collaboration with the Organisation for Economic Cooperation and Development (OECD) have already developed a framework for cooperation in the field of risk assessment methodologies (http://www.who.int/ipcs/en/) ICF Technical Exchange Conference

21. REACH becomes a reality • On 13th December 2005 following a marathon vote on over 1,000 amendments, REACH was approved by the European Parliament. • A second reading of the proposal is due in 2006 and REACH should enter into force in late 2006 or early 2007. • This will result in a phased 11-year programme for mandatory registration of around 30,000 substances. • REACH will transfer the burden of proof from authorities to industry for testing and risk assessment of chemicals. ICF Technical Exchange Conference

22. Phasing in of REACH R50 – R53 refer to toxicity to aquatic environment ICF Technical Exchange Conference

23. Current Version • Common policy as of 12 June 2006 • Runs to 673 pages • REACH Regulation (December 2005) runs to 270 pages. ICF Technical Exchange Conference

24. Registration • All substances produced or imported in quantities of one tonne or more per annum will have to be registered in a central database operated by the new EU Chemicals Agency (ECA) submitting information on properties, uses and safe ways of handling them. • Registration is not required for substances produced or imported in quantities less than one tonne, substances for use in research activities and polymers. • Information required will be proportional to production volumes and risk. • European Chemicals Agency will be based in Helsinki. ICF Technical Exchange Conference

25. Evaluation • Two type of evaluations: • Dossiers and Substances. • Competent authorities in member states can carry out evaluations of substances when they have justified reasons that there is a risk to human health or the environment. ICF Technical Exchange Conference

26. Authorisation • Use-specific authorisation will be required for ‘problematic’ substances. • These would include substances which were carcinogenic, mutagenic or toxic to reproduction (CMRs), substances which were persistent, bio-accumulative or toxic (PBTs) and substances which were very persistent and very bio-accumulative (vPvPs) and other substances with serious and irreversible effects on humans and the environment. • Authorisation will be provided to these substances if: • the risks can be adequately controlled or • on valid socio-economic grounds if there are no technological alternatives (i.e. ‘Benefit’ considerations). • Sunset date after which they can not be used. ICF Technical Exchange Conference

27. Restrictions • The Commission will continue to be able to restrict the use of certain dangerous substances at EU level, but REACH will introduce ‘cleaner’ procedures and allow for decisions to be taken more quickly than in currently the case. ICF Technical Exchange Conference

28. Costs to Downstream Users • The European Commission estimates the costs to downstream users of chemicals at €2.8 – 3.6 billion if the market behaves as expected with 1-2 % of substances withdrawn because continued production would not be profitable. • Costs could rise to €4 – 5 billion if industry faces higher supply chain adaptation costs. • These estimates include the direct costs passed on from the chemicals sector to downstream users. ICF Technical Exchange Conference

29. Total Costs • The latest estimate of the overall costs to the chemical industry and its downstream users are estimated to be €2.8 – 5.2 billion [9] and are claimed to be ‘managable’. • However, these costs could be subject to a considerable underestimate. • For example, the cost of chemicals will increase across the board as a result of REACH. • Secondly, the withdrawal of some chemicals will result in users having to switch to higher cost alternatives. • Arising from this there will be significant additional costs arising from producers having to modify production processes and reactions as a result of these supply chain adaptation costs. ICF Technical Exchange Conference

30. Pharmaceutical • Pharmaceutical manufactures will have greatly increased costs as they operate under current good manufacturing practice (cGMP) regulations and any changes to the production process such as replacing/substituting raw materials will result in them having to revalidate and comply with their change control procedures. ICF Technical Exchange Conference

31. Europe • This is most unfortunate from a European point of view as chemical production is one of the few manufacturing area in which we outperform the US. • European enterprises produce 31 % of the world's chemicals with the US producing 28 %. • The EU's chemicals industry is the third largest manufacturing industry generating 1.7 million jobs and indirect employment for more than 3 million people. ICF Technical Exchange Conference

32. A reminder of the costs of REACH • Estimates of the costs of REACH vary enormously • Latest EU costs state: • Euro 2.3 billion for producers • Euro 5.2 billion for downstream users ICF Technical Exchange Conference

33. Claimed benefits of REACH • Monday 17th October 2005 • Report from EU Trade union body Etuc and hosted by Guido Sacconi (EU rapporteur for REACH) • Research was carried out at University of Sheffield (UK). • Focused on asthma, dermatitis, chronic pulmonary disease (short term effects of chemicals) rather than cancer (long term effect) as in previous studies ICF Technical Exchange Conference

34. Health Benefits of REACH • Etuc Report • First 10 years • €0.66 – €6.2 billion (€ 3.5 billion median) • Over 30 years • €21 – €161 billion (€90 billion midpoint) • Commission Estimates (RPA report) • €27 billion over 30 years ICF Technical Exchange Conference

35. Claimed Benefits of REACH • The European Commission claim that positive occupational impact and public health impact of REACH is expected as chemicals are linked to respiratory and bladder cancers, mesothelioma, skin disorders, respiratory diseases, eye disorders, asthma. • Increased information on hazards and controls will assist in better implementation of existing legislation. • The latest fact sheet claims that if REACH succeeds in reducing chemical-related diseases by only 10%, the health benefits are estimated at €50 billion over 30 years. ICF Technical Exchange Conference

36. Glass in REACH ICF Technical Exchange Conference

37. Are fluid glass mass and solid glass products substances, preparations or articles under REACH? • Fluid glass mass which is produced during the manufacture of glass is a preparation that would render glass comparable to metal alloys. • Those substances in fluid glass mass which are minerals and are not chemically modified during the process do not need to be registered (??). • Other substances used e.g. as glass modifying agents, colouring/decolouring agents, coating agents, etc need to be registered. ICF Technical Exchange Conference

38. Preparation → Article • The glass • becomes an article when it has been given its final shape (e.g. a bottle, glass), but • remains a preparation if it cools to a glass mass for further processing. • I imagine that engraving would be considered further processing as would cutting and polishing. ICF Technical Exchange Conference

39. What about sand? • Sand: CAS#: 14808-60-7 EC#: 238-878-4 • Sand is listed in EINECS. • Sand would be treated as a mineral and as such would be exempt from registration unless it was further modified – but removal of impurities allowed? • Much of the sand used in lead crystal manufacture is chemically modified to remove impurities such as iron and as such, it appears to me that it would not have to be registered. • ESIS: Not listed in a priority list (as foreseen under Council Regulation No. 793/93) and is not classified in Annex 1 of Directive 67/548/EEC (ESIS - European chemical Substances Information System ICF Technical Exchange Conference

40. Other components in glass manufacture • Everything else used in glass manufacture is a substance and as such would have to be registered. • Some substances will cause problems • Lead oxide • Arsenic oxide (As2O5 and As2O3) (R45 – may cause cancer) • HF (RAR published – has identified glass manufacture as a source of exposure) RAR - Risk Assessment Report (under Directive 793/93) ICF Technical Exchange Conference

41. Aspects of US Concern ICF Technical Exchange Conference

42. REACH – a costly, burdensome and complex approach • The US shares the EU interest in regulating chemicals with a view to reducing or eliminating adverse health and environmental effects. • However, it is very concerned “that the European chemical regulations appear to adopt a particularly costly, burdensome and complex approach, which could prove unworkable in its implementation, adversely impact on innovation and disrupt global trade”. • The concerns of the US are understandable in that the new regime could affect the majority of US goods exported to the EU which amounted to $143 billion in 2002. • The main points raised by the US are as follows. ICF Technical Exchange Conference

43. General points of US concern • Costs are upfront – benefits will come much later. • Commission’s proposal imposes a stringent regulatory regime on thousands of chemicals that pose little risk to man or the environment • Evaluation is tonnage based rather than risk based • Echoed by RSC in submission to UK Parliament (mention sodium chloride!) • Resource problem – lack of testing capacity in the EU • note lack of progress on Council Regulation No. 793/93 ICF Technical Exchange Conference

44. Departs from International Regulatory Cooperation • Commission’s approach in developing its proposals has departed from the ongoing OECD cooperation. • Commission’s proposals could undermine other programs • OECD Screening Information Data Set (SIDS) • ICCA HPV initiative (International Council of Chemical Associations High Production Volume) ICF Technical Exchange Conference

45. Imposes substantial costs with uncertain benefits • Costs are substantial • No account taken of effects on • Prices • International competitiveness • Employment ICF Technical Exchange Conference

46. Adversely Impacts on SMEs • Small manufacturers account for the majority of EU chemicals and US industry • Face disproportionate costs • Some may simply exit the EU market • Must find ways of reducing the regulatory burden for SMEs. • European Chemicals Industry Council (CEFIC) estimate that 20% of chemical industry will carry 80% of costs of REACH • Mainly SMEs working on fine and speciality chemicals at low production volumes (430,000 people across the EU) ICF Technical Exchange Conference

47. Disrupt Global Trade and Supply Chains • Risk & Policy Analysts (RPA) state that there are 500,000 – 5 million different article types on EU market • An average of 10 – 50 substances per article • Proposals impose burdensome analytic and reporting and administrative requirements on downstream users – especially overseas manufacturers. • Downstream users worried that approach will disrupt global supply chains. • Manufacturers will just halt production when demand does not justify registration and testing costs. ICF Technical Exchange Conference

48. Adversely Impacts Innovation • Commission’s own assessment (RPA report) states that impacts on innovation are expected to be negative in that both money and expertise devoted to product development will instead be focussed on gathering and evaluating data on low-risk substances. • Chemicals R&D innovation and introduction of new substances will occur increasingly outside the EU (India and China in particular). ICF Technical Exchange Conference

49. Creates Market Uncertainty • Regulation does not provide sufficient information as to how decisions will be taken regarding the regulatory treatment of various chemicals. • Member state authorities, the Commission, the ECB all involved! • Lack of clarity will produce uncertainty in the market • This will also affect downstream users ICF Technical Exchange Conference

50. Unclear Administrative Coordination and Consistency • Central Agency (ECB), EU member states and the Commission all responsible for action. • Coordination problems will lead to uncertainty. • The one thing a business can not tolerate is uncertainty ! ICF Technical Exchange Conference