New EU-chemical policy

1. New EU-chemical policy

2. Overall Objective Sustainable development in Europe by: Protection of humans and environment Improvement of the chemical industry’s competitiveness in EU Larger transparency for the consumers Promotion of tests without the use of experimental animals Accordance with WTO obligations

3. ”The chemical pressure” + ELINCS (2.700) New substances since 1981 Full knowledge Limited knowledge App. 10.000 substances used in the paint industry Existing substances in 1981 EINECS (app. 100.000) App. 30.000 substances produced today > 1 ton

4. Shift in responsibility • The present system: • Producers of chemicals: Classification of danger (Hazard). • Authorities/EU make risk assessment==> burden of proof lies with the authorities • The future system: • Producers of chemicals + ”downstream users” (especially exposure data) responsible for data and risk assessment.==> the burden of proof lies with the industry

5. Where is our industry in this connection?

6. Registration UPSTREAM Production Chem.substances (A1,A2 additives; M1, M2 monomers) A1 A2 M1 M1 Cobolt Terpentin Data on consumption/ exposure Raw materials (pigments, binders, etc) Polymer Ex. Binder Physical goods Agent Danger data Products paint,adhesives,etc Ex. varnish Consumption (DIY, Prof., Industry) Ex. Production of windows DOWNSTREAM

7. Risk assessment Risk = Hazard x Exposure Data obligation: Producer of chemicals Downstream user

8. Categorisation of hazard Low Medium High SVHC*) CMR cat. 1 and 2 Hormonlike substances POP PBT + vPvB (very persistent, very bioaccumulating and toxic substances) Human Xn,Xi Giftig Meget Giftig Environ- ment R53 **) Miljøfarlig Miljøfarlig *) Substances of Very High Concern **) R53: May cause unwanted longtime effects to the aquatic environment

9. ExposureEnvironment + Humans Time Quantity Types of use How long How often How much How

10. Risk Assessment Increasing risk Increasing exposure High risk Medium risk Low risk Increasing danger

11. Registration Includes data on physical-chemical properties, hazard and exposure/use which together create the basis for a risk assessment Evaluation Quality control of presented registration data for substances >100 t/y and especially problematic substances. Permission for and additional request for tests can be demanded during the evaluation. Authorization of CHemicals Especially problematic substances must be authorized for any use of which they are a part.  Prof. Ind. Eksample. REACHUnity system for all chemicals: DIY

12. REACH Time Schedule (according to draft order May 2003) Quantity 2006 09 11 15 17 20 12 år Registration > 1 t/y Registration Eval. >100 t/y 18 months pre-registration > 1000 t/y Reg. E. Substances to be authorised CMR cat. 1, 2

13. 2700 ELINCS substances E CH R A Substances with obligatory authorization 30.000 of 100.000 EINECS substances >1000 t/y >100 t/y >10 t/y >1 t/y

14. Registration Costs

15. How much does REACH cost? Billion € • Total costs (RPA/commission) 3,6 • Total costs (CEFIC) 7,1 • Total costs (UK study) 8,7 • Indirect costs (CEFIC) 14 - 26 • Hospital savings (30-year period) 18 – 54 • 2 % of the French working force (French study) • 150.000 - 2.000.000 german jobs (ADL-study)

16. EU Legislation process General Where are we in the process on the EU Chemical policy?

17. EU’s most important institutions • COMMISSION: Appointed by the governments of the member countries for 5 years. Initiator of legislation • COUNCIL of MINISTERs: Government Representatives from member countries. Legislative function • PARLIAMENT: Directly elected and party organised. Cooperates with the Council in the legislation process

18. SOURCES OF LAW • EU Regulations: Immediately valid in the member countries after publication • Directives: Must go through an implementation phase in the member countries prior to becoming effective

19. The Danish Parliament’s Europe Committee • The Committee gives mandate to the Government • Coordinates across the Parliament’s line-committees and interacts with the Government In addition to this • The Parliament’s public information, debate and dialogue on the EU policy. • Co-operates with the other countries’ parliaments and Europe-committees

20. EU Legislation process TIme 2001 White paper Work up Interservice Internet consultation Proposal on EU regulation EU-Commission Now Autumn 2003? European Parliament EU Council of Ministers ++ year EU Regulation New EU chemical legislation 2006?

21. Dialogue with authorities European level: National level: - CEPE, FEICA etc. - The Danish Paintmakers’ Association - The Danish Adhesives & Sealants Association - The Co-operation & Information Committee of the Sealant Industry

22. Generally: We support the initiative for a new EU chemical legislation, but…. It must be operational

23. PRIMARILY TECHNICAL DIALOGUE PRIMARILY POLITICAL DIALOGUE White paper Work up Interservice Internet consultation Proposal on EU regulation EU-Commission European Parliament EU Council of Ministers EU regulation New EU chemical legislation

24. CEFIC DUCC European ex. CEPE - ’Advocacy’ group - Technical group Project in FDLF Danish Association White paper Work up Interservice Internet consultation Proposal on EU regulation EU-Commission European Parliament EU Council of Ministers EU regulation New EU chemical legislation

25. Internet hearing8 weeks - finishes 10th July, 2003 • Present phase: CEPE work • Technical working group • ’Advocacy’ group • Medio/ultimo June: Request from CEPE/ FEICA for national input (via FDLF and the Adhesives Association).

26. Other dialogue with Authorities • EU Parliament • 29. April: EU Event arranged by CEPE • 13. May: Meeting with Danish parlamentarians arranged by FDLF Council of Ministers • Letter from FDLF to the Danish Minister for the Environment • Meeting with • The Minister for the Environment? • The Minister for Trade & Economic Affairs? • The Parliament’s Europe Committee? • The Parliament’s Environment- & Planning Committee? • Future EU-parlamentarians?

27. EU’s new chemical policyProject in Danish Industry • The Danish Paintmakers’ Association • The Danish Adhesives & Sealants Association • The Co-operation & Information Committee of the Sealants Industry

28. Purpose • Preparation of an action plan for the implementation of EU’s chemical policy into the individual companies. • As “a side effect”: • Identify specific problems of the industry especially concerning ”workability” – is the legislation operational?

29. Economic framework A grant of 4.328.000 DDK from the DK-EPA for a 3-years project The Industry’s own finansing is DDK 2.885.750 (to be calculated as hours provided by the individual companies during the project)

30. Phase 1: Core project EU Chemical strategy plan Education & Information The industry (decision makers + technicians) Prephase Tools Pilot 1 The industry (decision makers + technicians) The industry (decision makers + technicians) Pilot 2 Pilot 3 The industry (decicion makers + technicians) The industry (decision makers + technicians) + Prof. customers + general public Action plan for implemetation of the new EU Chemmical policy in the individual company. Fase 2 ?

31. Temperature measuring Health test Treatment plan Phase 1: Core projekt EU Chemical strategy plan Education & Information The industry (decision makers + technicians) Prephase Tools Pilot 1 The industry (decision makers + technicians) The industry (decision makers + technicians) Pilot 2 The industry (decision makers + technicians) Pilot 3 The industry (decision makers + technicians) + Prof. customers + General public Action plan for the individual company for implementation of EU’s chemical policy Phase 2 ?

32. Expected results • The project is expected to have the following specific results: • Tools for the practical handling of the chemical policy in the individual company • An understanding in the companies of how the work and the new general view can be used in f. ex. product development and marketing • A dialogue with both ”downstream -” and ”upstream user”

33. Expected results (continued) • A number of pilot studies • A seminar and an education presenting the pilot comnaies’ experience with the chemical strategy plan • An overview of the consequences, which EU’s chemical policy will have for the industry • A general action plan for the companies’ implementation of the chemical policy

34. Project staff • Claus Ankjærgaard, Hempel (60%) • Per Langholz, Dyrup (10%) • Luise Nørgaard-Andersen, Dyrup (50%) • Dorthe Christensen, Dana Lim (30%) • Project management: Vibeke Plambeck

35. Internal Steering group • Vibeke Plambeck, FDLF (responsible) • Eva Bie Kjær, Hempel • Claus Birch, Dana Lim • Helle Simon Elbro, Dyrup • Walter Sebastian, FSO • Stig Hirsbak, Rambøll • Ivan Grønning, BASF

36. Internal Follow-Group = MSUFDLF: Association of danish paint and lacquer organisation. • Helle Simon Elbro, Dyrup (chairman) • Eva Bie Kjær, Hempel • Diana Schou, Esbjerg Farve- og Lakfabrik A/S • Jesper Hougesen, Beck & Jørgensen A/S • Jørgen Olsen, Beth Gydesen, Akzo Nobel Deco A/S • Rikke Østergaard, Teknos A/S • Poul Bastholm, Flügger A/S • Anders Fogh, Sicpa AB • Vibeke Plambeck, FDLF

37. External Follow-group • Vibeke Plambeck, FDLF (project-responsible) • Inge Werther, DK-EPA • Representative from DK-EPA, Area of Chemicals • Helle Simon Elbro, Dyrup • Eva Bie Kjær, Hempel • Walter Sebastian, FSO • Stig Hirsbak, Rambøll • Ivan Grønning, BASF A/S

38. Temperature measurementin Company XPreliminary considerations on consequences

39. General process of the project1) Temperature measurement in Company X Temperature ==> Health test ==> Treatment plan Pilot 1 ==> Pilot 2 ==> Pilot 3 ==> …………. 2003 2005

40. Temperature measurement in Company X • Measuring high volume substances: HPVC • Measuring low volume substances: LPVC • Measuring SVHC - Substances potientially to be authorized

41. Production volume of the substances Ton/producer/yea 10 100 1000 1 REACH Regulation categories HPVC LPVC ECB*) data *) European Chemicals Bureau data originate from - The regulation on risk assessment of existing substances from 1993 - Data reported from 1990 and forwards - HPVC = High Production/import Volume Chemicals (”high volume”) - LPVC = Low Production/import Volume Chemicals (”low volume”)

42. LPVC HPVC REACH Time schedule (according to draft for regulation May 2003) Quantity 2006 09 11 15 17 20 12 år Registration > 1 t/y Registration Eval. >100 t/y > 1000 t/y Reg. E. 18 months pre registration Substances with obligatory authorization CMR cat. 1, 2

43. Snowball effect SubstancesRaw materialsRecipes/Products (100x) (100x) (100x) Average: 60 substances per. recipe Average: 3 substances per. Raw mat. Average: 20 raw mat. per. recipe

44. The higher the volume - the earlier action must be taken Temperature measurement Measuring high volume substances

45. Determination of HPVC’sMethod ECB’s HPVC list Company x’s recipes Company x’s list of raw materials Firma x’s list of substances

46. Measuring high volume substances(HPVC) Substances App. 70 % is HPVC App. 80 % of raw materials contain min. one HPVC. Raw materials 100 % of recipes will be affected by the legislation in 2009. Products

47. Measuring high volume substances (HPVC)Action plan for COMPANY X • COMPANY X has HPVC’s in almost all products! • Action must be taken before 2009! • Action: Dialogue between raw material supplier Y and COMPANY X. • Will all HPVC’s used in COMPANY X’s raw materials be approved by raw material supplier Y for use in COMPANY X’s products?

48. The lower volume - the greater the risk of not surviving for economicall reasons. Temperature measurement Measuring low volume substances

49. Measuring low volume substances (LPVC)Some LPVC’s disappear, because they are too expensive to registrer >1 >10 >100 >1000 >10000 Produced volume tons/producer/year 10.000 0 1 10 100 1000 CEFIC estimate: 20-40% of low volume substances will not be registered Commission estimate: 8-12 % of ALL substances will not be registered

50. Determination of LPVC’s Company x’s recipes Company x’s list of raw materiale Firma x’s list of substances ECB’s LPVC list