1. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz REACH The EU Regulation on Registration, Evaluation, Authorisation and Restriction of CHemicals

2. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz 1.Motivation 2.Features 3.Positions and Concerns 4.History and Current State (Feb 2007) 5.How to Proceed Prof. Dr. Bernd Delakowitz

3. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz 1. 1. Motivation and Causes

4. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz World Chemicals Production 2000 Turnover totals up to € 1 565 billion (approx. twice the amount of global telecom industry)Turnover totals up to € 1 565 billion (approx. twice the amount of global telecom industry) 7 % of global income (GDP)7 % of global income (GDP) 9 % of global trade9 % of global trade EU: 31 % of world´s chemicals prod. (US 28 %)EU: 31 % of world´s chemicals prod. (US 28 %) EU: Some 4,7 million people employedEU: Some 4,7 million people employed

5. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz Structure of EU Chemicals Industry Some 20 000 SMEs representing 96% of all chemical enterprises in the EUSome 20 000 SMEs representing 96% of all chemical enterprises in the EU EU´s third biggest employerEU´s third biggest employer Biggest contributor to EU´s trade surplusBiggest contributor to EU´s trade surplus 500 000 downstream users500 000 downstream users

6. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz HS&E Problems  EU distinguishes between so called „old“ chemicals entering the market before 1981 (ca. 102.000, listed in EINECS) and „new“ chemicals (> 3.200) after 1981  General lack of knowledge about the properties of old chemical substances because up to 1981 it was possible to market the chemicals without any formal authorisation (and insufficient evaluation)  Vast majority of existing chemicals (around 105.000) with unknown or not sufficiently known properties. So far, only about 9.000 (= 8%) chemicals are sufficiently investigated with respect to the human´s health and the natural environment

7. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz HS&E Problems  Various old installations for bulk chemicals with high energy and resource demand, significant emissions to the environment, old technologies (e. g. chlorine production in mercury cells, fertilizer production)  A patchwork of too many and often not consistent regulations both on European and member states levels

8. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz Environmental Water Problems Resulting from Hazardous Chemicals Toxification with chemicals Eutrophication (nitrogen) Contamination due to oil discharges

9. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz HS&E Problems Problematic chemicals not only pollute natural water resources but contaminate animals and men Brominated flame retardants, used in fabrics and TVs Brominated flame retardants, used in fabrics and TVs PFCs, from manufacture and use of non- stick coatings (e.g. PTFE/Teflon), anti-stain treatments (Scotchguard) and telomers (e.g. McDonalds food packaging) PFCs, from manufacture and use of non- stick coatings (e.g. PTFE/Teflon), anti-stain treatments (Scotchguard) and telomers (e.g. McDonalds food packaging) Anti-fouling additive TBT has decimated shellfish stocks Anti-fouling additive TBT has decimated shellfish stocks Food cans continue to contain a proven hormone disrupter, bisphenol A Food cans continue to contain a proven hormone disrupter, bisphenol A

10. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz Regulatory Problems Current system for chemicals management in the EU is inefficient Current system for chemicals management in the EU is inefficient Difficult to identify and to address risks: Difficult to identify and to address risks: –Lack of information about substances on the market produced before 1981 –Burden of proof on public authorities ! –No efficient instrument to deal with problematic substances

11. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz 2.Publication,Principles and Features of REACH

12. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), estab- lishing a European Chemicals Agency,.... Official Journal of the European Union ISSN 1725-2555 L 396, Volume 49, 30 December 2006 - Acts whose publication is obligatory -

13. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz Objectives of REACH To develop an integrated and coherent chemicals policy reflecting the precautionary principle and the principle of sustainabilityTo develop an integrated and coherent chemicals policy reflecting the precautionary principle and the principle of sustainability To increase the safety of humans and the environment in the handling of chemicals and at the same time to improve the com- petitiveness of the chemicals industry in Europe (???)To increase the safety of humans and the environment in the handling of chemicals and at the same time to improve the com- petitiveness of the chemicals industry in Europe (???)

14. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz What is REACH A single regulatory framework for registration, evaluation and authorisation of chemicals to replace the current dual system for assessing risks of "existing old" badly evaluated (placed on market before 1981) and „new“ much better known substances.A single regulatory framework for registration, evaluation and authorisation of chemicals to replace the current dual system for assessing risks of "existing old" badly evaluated (placed on market before 1981) and „new“ much better known substances.

15. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz REACH Requirements The REACH draft originally required (re-) assessment of ca. 30.000 chemicals currently used in EU chemicals industry and its down- stream users based on quantities produced (> 1t/a) - volume-oriented approach -

16. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz REACH Requirements Reversal of burden of proof from authorities to industry (manufacturer, importer, supplier, downstream user) for testing and risk assessment of chemicals. In other words: Shift of responsibility from authorities to industry

17. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd DelakowitzSubstance: Classified as dangerous and produced in certain volumes (per article type) Intended release Registration Unintendional release Pre-Registration Agency may require registration REACH: Registration

18. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz REACH: Registration All substances („phase-in“ articles, EINECS) or newly produced („non-phase-in“) or imported in quantities of > 1.000 t/a >100 t/a for environmental hazardous substances (R50/53) > 1 t/a for CMR-substances will have to be registered at the REACH Agency until 11/2010

19. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz REACH: Registration Registration not required forRegistration not required for - substances for use in research activities (!) -polymers -radioactive substances -substances in drugs or nutrient additives -REACH appendix IV (e.g. water, natural oils) -REACH appendix V (e.g. minerals, coal) -already registered or re-imported substances Information required will be proportional to production volumes and risk potentialsInformation required will be proportional to production volumes and risk potentials

20. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz REACH: Pre-Registration Old „phase-in“ substances (EINECS) > 1 t/aOld „phase-in“ substances (EINECS) > 1 t/a Without pre-registration no interim periods for registration of new „non-phase-in“ substances can be claimed (Art. 23)Without pre-registration no interim periods for registration of new „non-phase-in“ substances can be claimed (Art. 23) Pre-registration period:Pre-registration period: 01. June 2008 until 01. December 2008

21. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz REACH: Notification and Registration Deadlines (interim periods for registration) Start: 06/2007 11/201005/201305/2018 > 1000 t / > 1 t CMR > 100 t R50-53 100 - 1000 t 10 – 100 t Registration: Deadlines

22. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz REACH: Evaluation Two types of evaluations: dossiers (already existing information) and substances evaluation and testing, respectively.Two types of evaluations: dossiers (already existing information) and substances evaluation and testing, respectively. Member States' competent authorities can carry out evaluations of substances when they have justified reasons that there is a risk to human health or to the natural environment (such as rivers, animals, plants and groundwater).Member States' competent authorities can carry out evaluations of substances when they have justified reasons that there is a risk to human health or to the natural environment (such as rivers, animals, plants and groundwater).

23. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz REACH: Evaluation Provide confidence that industry is meeting obligations - Prevent unnecessary (animal) testing Dossier evaluation Substance evaluation Check test proposals Compliance Output (REACH database at Agency, SIEF - Substance Information Exchange Forum): Further information decisionsFurther information decisions Info to other parts of REACH/other legislationInfo to other parts of REACH/other legislation Examine any information on a substance

24. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz REACH: Data Sharing Information > 10 years – freely available Information > 10 years – freely available At registration – registrants indicate if share non-animal data At registration – registrants indicate if share non-animal data Non-phase-in substances (= new, not in articles so far): Non-phase-in substances (= new, not in articles so far): –Agency enables contact with previous or potential registrants –Studies involving vertebrate animals not repeated Phase-in substances (= old, in articles and market): Phase-in substances (= old, in articles and market): –Potential registrants of similar substances have access to ‘SIEF’ –Share data (incl. new tests) and costs –Sharing mandatory (vertebrate animals) Avoidance of unnecessary animal testing + to save costs

25. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz REACH: Authorisation Authorisation will be required for highly problematic substances - CMRs (carcinogenic, mutagenic or toxic to reproduction), PBTs (persistent, bioaccumulative and toxic), vPvBs (very persistent and very bioaccumulative) and other substances with serious and irreversible effects on humans and the environment

26. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz REACH: Authorisation Authorisation will be granted to these substances if risks can be adequately controlled or on valid socio-economic grounds if there are no technological alternatives

27. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz Ensure risks from substances of very high concern are properly controlled or that they are substituted Ensure risks from substances of very high concern are properly controlled or that they are substituted. REACH: Authorisation Applicant to show: Applicant to show: –adequate control of risks, or –social and economic benefits outweigh the risks Socio-economic authorisation - time-limited (REACH, Appendix XIV) Socio-economic authorisation - time-limited (REACH, Appendix XIV) Supplier may sell authorisation down supply chain Supplier may sell authorisation down supply chain

28. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz Downstream Users (DU) Manufacturer/importer registration to cover all uses identified by downstream users Manufacturer/importer registration to cover all uses identified by downstream users DU must DU must –implement supplier’s risk reduction measures for identified uses DU need to: DU need to: –enter into dialogue with their suppliers –consider consortia building and/or cost sharing DU may need to apply for authorisation DU may need to apply for authorisation

29. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz REACH: Agency New agency to manage the day-to-day running of the system – Helsinki, Finland (EU Council 12 Dec 2004)New agency to manage the day-to-day running of the system – Helsinki, Finland (EU Council 12 Dec 2004) Responsibilities: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)

30. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz no y yes no Determination of annual production volumes ≥ 1 T yr -1 ≥ 10 T yr -1 ≥ 100 T yr -1 ≥ 1.000 T yr -1 Substances evaluation Dossiers evaluation Authori- sation Restriction RegistrationEvaluation Authorisation and restriction y Authorisation or restriction not required Applies not for REACH Can risks be measured and be handled? red = high risk green low risk Registrati on Pre- registra- tion Decision for implementing REACH Risks on human health and environme nt? no < 1 T yr - 1 Performance of REACH Performance of REACH [taken from S. Guether/SAXONIA, 2006]

31. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz BDI-Hilfestellung zur Erfüllung der Anforderungen aus der REACH-Verordnung 0. Allgemeine Hinweise zur Vorbereitung auf REACHVersion 1.2 2.10.2006 REACH: Helpdesks, Tools and Links http://www.bdi-online.de/de/fachabteilungen/7240.htm http://132.195.14.44/cgi-bin/komnet-f/asinfo.cgi?setcat=RCH(Chatt-Room) http://www.reach-info.de/01_aktuell/01_aktuelles.htm Official UBA-page on REACH

32. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz 3. Positions and Concerns

33. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz Positions and Concerns A public hearing held on 19 January 2005 in the EU Parliament gave the opportunity to a wide variety of stakeholders to express their views and concerns upon REACH

34. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz Positions and Concerns: Chemical Industry For the chemicals industry and its down-stream users (e.g. carmakers), the Commission's plans for REACH conjure up fears of bureaucracy, lack of flexibility and loss of competitiveness („... stifling innovation“, „.. risk of de- industrialisation“, etc.)

35. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz Positions and Concerns: Chemical Industry (2) Industry claims that the Commission´s REACH system is too costly, unworkable and will result in up to 1,4 Mio job losses in the sectorIndustry claims that the Commission´s REACH system is too costly, unworkable and will result in up to 1,4 Mio job losses in the sector In 2004, the leaders of the 'big three' (UK´s T. Blair, Germany´s G. Schroeder and France´s J. Chirac) teamed up with their industries to condamn the "bureaucratic and unnecessarily complicated" draft legislationIn 2004, the leaders of the 'big three' (UK´s T. Blair, Germany´s G. Schroeder and France´s J. Chirac) teamed up with their industries to condamn the "bureaucratic and unnecessarily complicated" draft legislation

36. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz Positions and Concerns: Economic Impact Commission estimates the overall economic impact for chemicals industry and downstream users at between € 2.3 - 5.4 billion over 11 years (less than 0.1% of the annual turnover of the sector or € 0,5 per person per year in the EU)

37. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz Positions and Concerns: Economic Impact These figures are heavily disputed by industry studies performed by the German BDI and the „Mercer“ study in France which calculates the costs caused by REACH up to € 54 billion. Industry, therefore, insisted on an independent extensive impact assessment of the Commission's proposal

38. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz Positions and Concerns: Economic Impact The NGOs, on the other hand, compared the costs to industry with the financial gains from reductions in public health costs, less negative impacts on the environment and productivity savings.The NGOs, on the other hand, compared the costs to industry with the financial gains from reductions in public health costs, less negative impacts on the environment and productivity savings. A study for WWF (UK, David Pearce, 2004) estimated the financial gains at around € 230 billion by 2020A study for WWF (UK, David Pearce, 2004) estimated the financial gains at around € 230 billion by 2020

39. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz 4. History and Current State (February 2007)

40. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz Jul-Dec 2004 ( Netherlands presidency ) Member States begin detailed analysis of REACH. The new Parliament starts initial discussions Jan-Jun 2005 (Luxembourg presidency) Parliament begins first reading with discussions in committees, followed by votes on amend- ments - Environment Committee vote due by summer. Member States continue detailed analysis Jul-Dec 2005 ( UK presidency ) Plenary vote ends Parliament's first reading (17 Nov. 2005). Member States finalise agreement on key issues, followed by Common position after Parliament’s first reading REACH: Agenda

41. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz REACH: Agenda Jan-Jun 2006 ( Austria presidency ) Commission modifies REACH proposal based on Common position and internal Commission debate. Parliament’s second reading begins 27 June 2006: Common position adopted by the Council with a view to the adoption of a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

42. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz Jul-Dec 2006 ( Finland presidency ) Jan-Jun 2007 ( Germany presidency ) 04 and 11 Dec 2006: Plenary vote ends Parliament's second reading. Conciliation to resolve differences and finalise REACH. Member States agree on legislation to be published in Official Journal. REACH Regulation (EC) 1907/2006 (announced 18. Dec. 2006) is published on 30. December 2006 in Official Journal (L 396, Vol 49) REACH becomes effective on 01. June 2007 Notification and information exchange starts 01. June 2007; (pre-) registration starts 01. June 2008 REACH: Finalisation

43. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz 5. How to proceed

44. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz REACH: The OSOR concept The British-Hungarian OSOR proposal (One Substance - One Registration) aimed at allowing companies to form consortia to share (and hence reduce) the costs of registration. Potential conflicts need to be resolved concerning the mandatory sharing of patent protected data by industry and compliance with international intellectual property law.

45. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz The need to make REACH more workable for industry and to improve the competitiveness of EU businesses at international levelThe need to make REACH more workable for industry and to improve the competitiveness of EU businesses at international level Note: REACH vs. Global Harmonisation System (GHS) The case of imported finished products containing many chemicals, such as cars, needs to be looked intoThe case of imported finished products containing many chemicals, such as cars, needs to be looked into The need to give more attention to the particular situation of SMEs (bureaucratic burdens, acceptance)The need to give more attention to the particular situation of SMEs (bureaucratic burdens, acceptance) To prioritise chemicals' testing and registration starting with substances presenting the highest risk for health and the environment (independant from the quantities produced)To prioritise chemicals' testing and registration starting with substances presenting the highest risk for health and the environment (independant from the quantities produced) REACH: Improvements

46. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz REACH: Deadlines (Short-term) Information exchange within supply chains (manufacturer, importer, supplier, user) and notification to Agency starts 01. June 2007Information exchange within supply chains (manufacturer, importer, supplier, user) and notification to Agency starts 01. June 2007 Registration of new „non-phase-in“ substances starts 01. June 2008 (June/2007 for > 1 t/a CMR substances)Registration of new „non-phase-in“ substances starts 01. June 2008 (June/2007 for > 1 t/a CMR substances) Pre-registration of old „phase-in“ substances starts 01. June 2008 and ends 01. Dec. 2008Pre-registration of old „phase-in“ substances starts 01. June 2008 and ends 01. Dec. 2008 Notification and registration for high-volume and hazardous substances ends November 2010Notification and registration for high-volume and hazardous substances ends November 2010

47. Hochschule Zittau/Görlitz (FH) – University of Applied Sciences Prof. Dr. Bernd Delakowitz Thank you for your attention