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26 November 2004 Meeting on REACH organized by the American Chamber of Commerce in Poland

26 November 2004 Meeting on REACH organized by the American Chamber of Commerce in Poland Hotel Marriott, Warszawa Wojciech Lubiewa-Wieleżyński Polish Chamber of Chemical Industry Andrzej Krześlak Environmental Management Centre in the Chemical Industry

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26 November 2004 Meeting on REACH organized by the American Chamber of Commerce in Poland

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  1. 26 November 2004 Meeting on REACH organized by the American Chamber of Commerce in Poland Hotel Marriott, Warszawa Wojciech Lubiewa-Wieleżyński Polish Chamber of Chemical Industry Andrzej Krześlak Environmental Management Centre in the Chemical Industry Industrial Chemistry Research Institute Polish Chamber of Chemical Industry Marcela Palczewska-Tulińska Group for Physicochemical Properties of the Technological Processes Industrial Chemistry Research Institute Polish Chemical Industryvs. REACH 1

  2. Up-to-date activities - role of the ChemLeg Project • White Paper on future chemicals’ policy published on 27 February 2001; • ChemLeg Project launched in May 2001; • Scope of the Project: • Classification, packaging and labelling, • Preparation of MSDSs, • Notification of new substances, • Risk assessment, • Restrictions in marketing and use; • Translation of the White Paper and its distribution to the Polish chemical companies. 2

  3. Role of the ChemFed/ChemLeg-2 Project • ChemFed/ChemLeg-2 Project launched in May 2003 – termination planned for 30 April 2005; • 5 major clusters: • Chemicals’ legislation – REACH: • Establishment of the ChemFed/ChemLeg-2 Task Force in CEFIC • Human health and environmental protection – IPPC; • Chemicals’ transport – SQUAS; • Social policy and employment – cooperation with ECEG; • Economical benchmarking; • Project Coordinator: 3

  4. Sustainable development 4

  5. Basic problems concerning registration • Approximately 25 000 existing substances at the tonnage band 1 – 100 tons annually will require registration within 11 years after entry into force; • Assumption: companies will register as late as possible → ussually just before 2017; • Consequences: • Unpredictable rating of market and profitability of substances; • Purchasers of chemicals will know very late in case of substances’ majority, whether they will be still available on the market after 2017. ? 2006 2017 5

  6. Basic problems concerning registration • 30.000 substances to be registered within 11 years; • Simplification: no multiple registrations. Parallel registrations in all tonnage bands Consecutive registration in tonnage bands Daily no. of registrations Daily no. of registrations Years after entry into force Years after entry into force 6

  7. Doubts – Example No. 1 derived from SDS • Adhesive X → annual production: 1.8 t → tonnage band 1 – 10 t: • Components: • Cyclohexane: 11 – 38 – 50/53 – 65 – 67 45% • Acetone: 11 – 36 – 66 – 67 4% • Ethyl acetate: 11 – 36 – 66 – 67 21% • Classification of the adhesive: 11 – 36/38 – 50/53 – 65 – 67: • (F) Highly flammable; • (Xi) Irritating to eyes and skin; • (N) Very toxic to aquatic organisms; may cause long - term adverse effects in the aquatic environment; • (Xn) Harmful: may cause lung damage if swallowed; vapours may cause drowsiness and dizziness. • There is no CSR required for the preparation; none of the components will be registered→ all components below 1 t; • Therefore, we strongly support prioritization of substances based on risk instead of tonnage band 7

  8. Doubts – Example No. 2 derived from SDS • Adhesive Y → annual production: 8 t → tonnage band 1 – 10 t: • Components: • Cyclohexane: 10% → 0.8 t • Acetone: 62% → 5.0 t • Butane-2-one 10% → 0.8 t • Will be acetone only registered, additionally without CSR ? • If the components of differentiated adhesives are repeated – should they be registered only once or several times accordingly to the number of marketed final products with the deadline resulted from the tonnage band ??? 8

  9. Doubts – Example No. 3 derived from SDS • Product ZZZ → annual production: 11 t → tonnage band 10 – 100 t: • Components: • Polyols: 80 - 90% → exempted from registration • Diethanoloamine:1 - 5% → R22 – 38 – 41 – 48/22 • Triethylenediamine:2 - 8% → ? • NONE OF THE ABOVE COMPONENTS WILL BE REGISTERED; • Product should be classified at least as irritant; • Triethylenediamine – no tests performed, no data available. 9

  10. Doubts – Example No. 4 derived from SDS • Automotive lacquer → annual production: 30 t → tonnage band 10 – 100 t: • Components: • Toluene: 36% → 10.8 t • Butane-2-one 27% → 8.1 t • Butyl acetate 10% → 3.0 t • Acetone: 7% → 2.1 t • Cyclohexanone 3% → 0.9 t • Registration for the components 1, 2, 3, 4; • Substances 2, 3, 4 – standard information requirements according to Annex V – no CSR – deadline for registration 11 years ? • Toluene – additional standard information requirements according to Annex VI – CSR required – deadline for registration 11 years ? 10

  11. Doubts concerning evaluation • Substances marketed above 100 t annually; • Draft decision concerning evaluation prepared by competent authority of one Member State submitted then for approval to the competent authorities of the remaining 24 Member States, will unnecessarily prolong decision making process – this will enlarge inertia of the whole system; • CEFIC and selected delegations propose Agency as the Central Entity fully responsible also for the evaluation process. 11

  12. Doubts concerning evaluation – duplication of work • Company Amanufactures substance X in the tonnage band > 1000 t annually in Germany → evaluation performed by the German Competent Authority; • Company B manufactures the same substance X in the tonnage band > 100 t annually in France → evaluation performed by the French Competent Authority; • Company C imports the same substance Xin the tonnage band > 100 t annually on the territory of Spain → evaluation performed by the Spanish Competent Authority; • Consequences: • Duplication of the same work; • Necessity of statements harmonization in case of the substance X by differentiated tonnage bands (differentiated test requirements); • Unjustified costs which may be avoided. In case the companies A,B and C form a consortium – only one competent authority will be in charge 12

  13. Activities in Poland • Impact assessment of REACH implementation in Poland – starting of the activities in September 2003 with support of Industrial Policy Department of the Polish Ministry of Economy, Labour and Social Policy; • Industrial Chemistry Research Institute, Warsaw, Poland – selected as the entity responsible for independent initial analysis; • Continuation of the work in 2004. 13

  14. Preliminary results • Surveyed companies employ more than 20 000 people and operate with annual turnover above 1.6 milliard € (ca. 7% of the whole sector in terms of employment); • Ca. 700 chemicals were analysed: • 59 substances were identified as existing substances from the priority lists; • 232 substances are listed in Annex I of Directive 67/548/EEC (29th ATP); • 189 substances as „existing” listed on EINECS; • 239 substances exempted from registration as polymers or as substances mentioned in Annex II or Annex III of the REACH regulation draft of 29 October 2003. 14

  15. Analyses made in Poland in 2003 66% 15

  16. Results of analysisexamples – small company 16

  17. Results of analysisexamples – medium sized company 17

  18. Results of analysis, examples – medium sized company (cont.) 18

  19. Results of analysisexamples – big company 19

  20. Preliminary results – cont. • It was estimated that registration under the REACH system will cover ca. 5000 substances; ca. 1000 substances will be subject of testing and ca. 200 will fall under authorisation procedure; • Total costs are estimated in the range of 340 – 600 million € (however taking into account other sources of information – for example DOW EUROPE S.A., VCI data or Procter & Gamble, these costs may be even 5 times higher); • In big chemical companies ca. 5 – 10% of employees may lose work places resulting from shut-down of unprofitable plants; • In case of small enterprises (in particular when production profile is not diversified) the companies as a whole may be shut-down; • In some cases increase of production cost may amount from few dozens up to even several hundreds per cent. 20

  21. Number of chemicals under REACH requirements - estimation • Registration 30 000 5 000 • Evaluation 5 000 1 000 • Authorisation 1 600 ? 200 Requirements 21

  22. Activities planned in 2004 • Extended analysis including bigger number of enterprises, especially small companies employing below 50 people; at least 50 – 100 such small companies should be analysed; • Including other branches using the chemical industry products (e.g., textile, automotive, leather industries, etc.); • An impact on innovation and competitiveness included; • The costs of Polish laboratories’ adjustment to the GLP. 22

  23. Tests vs. GLP requirements • In Poland only two entities are certified in GLP system; a few fulfill requirements resulted from the Parliament Act on tests and certification of 3 April 1993; • All issues connected with accreditation, authorisation and notification of goods as well as performing the tests by certified laboratories are regulated by the Parliament Act on system of compatibility assessment of 30 August 2002 (Polish Official Journal No. 166, item 1360), which entered into force on 1 January 2003; • There will be deficiency of authorized laboratories to carry out studies and tests in the framework of REACH system, laboratories, which would be accepted by the other EU Member States; • Chemical companies in Poland wishing to place their products on the national and European markets will be forced to order the relevant tests to the certified laboratories operating abroad, bearing high costs…, or to abandon development. 23

  24. Independent estimations – Registration costs in thousand $for the new substances Source: Herbert Frankenstein, BASF Poland Ltd. 24

  25. Advocacy Process • Meeting of the PIPC, Polish industry and Polish Ministry of Economy and Labour Experts with the Representatives of BASF AG held on 5 October 2004 at the BASF Polska Ltd. premises, Warsaw, POLAND; • Chemistry & Art: 11-14 October 2004 at the EP, Brussels; • Meeting with Polish MEPs organised by PIPC in cooperation with BASF Representatives, 19 October 2004 at the EP, ASP Building, Brussels; • Dutch Presidency Workshop on REACH Impact Assessment, 25-27 October 2004, The Netherlands; • Permanent cooperation with Polish MEPs, Polish Government and the Parliament (both chambers: Sejm & Senate). 25

  26. Other international activities • EU Council: REACH Ad-hoc Working Group on Chemicals: • Analysis and discussion on the draft regulation following the particular chapters (Titles); • Discussion on the proposals of individual delegations – eventual approval; • Memorandum of Understanding (MoU): • Published in February 2004, signed in March 2004; • Parties: DG Enterprise, DG Environment and Union des Industries de la Communauté Européenne / Union of Industrial and Employers’ Confederations of Europe – UNICE, European Chemical Industry Council CEFIC; • Additional Impact Assessment of REACH with the following scope: • Analysis of the potential impacts of REACH on business throughout the supply chain; • Analysis of the potential impacts of REACH on innovation; • Analysis of the potential impacts of REACH on New Member States: • Selected companies of specialty chemicals sector in Poland, Czech Republic and Slovenia; • Contractor for the first two bullets: KPMG, in case of third bullet: IPTS JRC, Seville, Spain; • Title of the study: „Techno-economic case studies to illustrate the ability of chemical firms in selected NMS to cope with the implementation of REACH”. 26

  27. Questions and doubts concerning MoU • One agreed contractor should be selected to perform whole study – why is distinction between „old fifteen” and „new ten” still maintained artificially? • Decision to analyse specialty chemicals sector – justified in case of Slovenia; Poland and Czech Republic are focused rather on commodity chemicals; • Scope of the questionnaires considerably exceeded beyond REACH subject matter; • Resources for the study → scope: 3 – 4 companies to be analysed in each country (max. 12 enterprises); • The goals to achieve from the worked out study presented by EC and chemical sector in Poland are at the crossroads and not complementary. 27

  28. Our views and expectations • REACH too bureaucratic and unworkable in the form of draft of 29 October 2004; • Prioritisation of substances – basic criterion →risk for the health and environment not only tonnage band; • Flexibility of the company’s decision – registration performed individually or in consortia (excluding tests on animals); • Centralized role of the Agency – should be also responsible for the evaluation procedure. 28

  29. Thank you for your attention • Contact: Wojciech Lubiewa-Wieleżyński President of Board of the Polish Chamber of Chemical Industry tel. +48-22-828-75-06 to 07, fax: +48-22-829-73-39 e-mail: lubiewa@pipc.org.pl Andrzej Krześlak Environmental Management Centre for the Chemical Industry Industrial Chemistry Research Institute tel. (0-22) 568-20-33, fax: (0-22) 568-23-90 e-mail: Andrzej.Krzeslak@ichp.pl Polish Chamber of Chemical Industry e-mail: Andrzej.Krzeslak@pipc.org.pl Marcela Palczewska-Tulińska Group of the Physicochemical Properties for the Technological Processes Industrial Chemistry Research Institute tel. (0-22) 568-20-33, fax: (0-22) 568-23-90 e-mail: Marcela.Palczewska-Tulinska@ichp.pl 29

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