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REACh

REACh. Registration, Evaluation and Authorization of Chemicals. REACh: The New Toxicology Frontier. and Restriction!. Ohio Valley SOT. Wednesday, August 26, 2009. Presenters. Jennifer Galvin, PhD, DABT, CIH Manager, Industrial Hygiene & Toxicology ConocoPhillips.

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REACh

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  1. REACh Registration, Evaluation and Authorization of Chemicals REACh: The New Toxicology Frontier and Restriction! Ohio Valley SOT Wednesday, August 26, 2009

  2. Presenters Jennifer Galvin, PhD, DABT, CIH Manager, Industrial Hygiene & Toxicology ConocoPhillips Tracy Hammon, MS, DABT Director, Product Safety ConocoPhillips

  3. Overview • What is REACh? • Why REACh? • Goals of REACh • Impacts of REACh • General Information • Information Requirements • Technical Dossier • Chemical Safety Report • Extended SDS

  4. What is REACh? • New EU Chemicals Regulation • REACh : Registration, Evaluation, Authorization and Restriction ofChemicals • REACh replaces 40 existing EU Chemical Regulations and Directives

  5. Stages of REACh • Pre-registration: by December 2008 • Registration:for substances ≥ 1 ton/yr • Evaluation:for high volume substances which are of highest concern • Authorization:only for substances of highest concern • Restriction:the Safety net The European Chemicals Agency (ECHA) was establishedto manage the system

  6. REACh Timeline http://guidance.echa.europa.eu/docs/guidance_document/nutshell_guidance.pdf

  7. Why REACh? • Lack of knowledge about chemical hazards on the EU market. • Prior legislation was regarded as slow & burdensome. • Incomplete information on existing chemicals vs. new chemicals. • The burden of proof was on regulators.

  8. Goals of REACh • Enhance transparency and efficiency • Close data gaps between existing & new substances. • Manage and control potential hazards and risksto human health and the environment from the manufacture, import and use of chemicals within the EU

  9. Impacts of REACh • REACh is a global business issue that will drive major changes in the way chemical businesses are organized • REACh has the potential to be a major threat to supply chain continuity • Clear and decisive leadership and management is needed

  10. Businesses need to understand how valuable these substances are to them, and plan to make effective business decisions based on this knowledge. Decisions made today will impact future business practices

  11. No data = No market

  12. REACh is a substance-specific regulation PRODUCT

  13. Product This product contains 8 substances A B C Therefore, this product will require 8 registrations D E F G H

  14. Multiple Expert Requirements • lawyers • lobbyists • communicators • IT-specialists • regulatory experts • physicians • Toxicologists • hygienists • researchers • process engineers • purchasers & logistics • marketing network • Export/Import coordinators

  15. Impacts of REACh • Burden of proof has shifted to industry • Industry will have to prepare a comprehensive document including: • Hazards • Risks • Risk management

  16. Classification & Labeling • Under the new Global Harmonized System • Each substance will be required to undergo classification • Under REACh, this classification will be documented in the registration dossier

  17. Identified Uses • Use of the substance must be included in the registration • If substance is hazardous, exposures need to be assessed

  18. REACh Phases Pre-Registration SIEF Formation Registration Evaluation Authorization Restriction

  19. Pre-Registration • Phase-in Substances • Pre-registration deadline December 2008 • Approx. 143,000 existing substances were pre-registered • ECHA received about fifteen times more pre-registrations than expected

  20. SIEF • Substance Information Exchange Forum • Purpose: • Data sharing (compulsory) • Agreement on Classification and Labeling

  21. Registration • Substances > 1 ton/year • Develop Technical Dossier • Reduced requirements for intermediates • Chemical Safety Assessment • Classification

  22. Technical Dossier • Required for registration • Information requirements – dependent on tonnage band • Contents: • Information on manufacture & use of substance • Physical characteristics, toxicological & ecotoxicological properties • Proposals for testing if appropriate • Indication of information submitted that should not be made available on internet & why

  23. Proposals for testing….if appropriate This is not a regulation that requires testing • Provide the data available • Do the risk assessment • Determine data gaps • Drive testing requirements

  24. Source: http://www.api.org/ehs/health/upload/API_REACH_Guide.pdf

  25. All Substances >1 ton/year Physical Tox/Ecotox Requirements Source: http://www.api.org/ehs/health/upload/API_REACH_Guide.pdf

  26. + 10 - 100 tons/year Source: http://www.api.org/ehs/health/upload/API_REACH_Guide.pdf

  27. + 100 - 1000 tons/year Source: http://www.api.org/ehs/health/upload/API_REACH_Guide.pdf

  28. + > 1000 tons/year Source: http://www.api.org/ehs/health/upload/API_REACH_Guide.pdf

  29. Evaluation • Substances > 10 tons/year • Chemical Safety Assessment • Requires detailed Chemical Safety Report • Required if a substance is dangerous, PBT or a vPvB • Risk characterization on exposures from intended uses • Risk Characterization

  30. Chemical Safety Assessment • Safety (physico-chemical) • Human health • Evaluate data • Classification and labelling • Establish Derived No-Effect Level (DNEL) • Environmental • Evaluate data • Classification and labelling • Establish Predicted No-Effect Concentration (PNEC)

  31. DNELs and PNECs • DNEL: Derived No Effect Level • PNEC: Predicted No Effect Concentration

  32. Manufacture and intended uses substance life cycle (including disposal/recycling) Include processes and tasks frequency and duration (how often and how long?) operational conditions representative exposure data or modelling data What risk management measures are required? For each human population exposed Workers Consumers Indirect Included as an appendix to the Safety Data Sheet (SDS) Now called an Extended Safety Data Sheet (eSDS) Exposure Scenarios

  33. Risk Management Measures • Must address workers, consumers, and the general public • For workers, consider… • Hierarchy of control • Principles of Good Control Practice (COSHH) • All routes of exposure (e.g., inhalation, dermal, ingestion) • Determine residual risk • Risk Characterization • compare exposure with the relevant DNEL

  34. Environmental Assessment PBT Persistent, Bioaccumulative & Toxic vPvB very Persistent & very Bioaccumulative

  35. Extended Safety Data Sheet (eSDS) • Used to communicate hazard down the supply chain • Increased requirements compared to current EU standard • Exposure scenarios

  36. Authorization • Required for all substances of very high concern • Approx. 1,500-2,000 substances • Time limited • Substances of very high concern are: • CMR (Carcinogen, Mutagen or Toxic for Reproduction Cat.1 or 2) • PBT (Persistent & Bioaccumulative & Toxic) or • vPvB (Very Persistent & Very Bioaccumulative & Toxic) • substances of equivalent level of concern • Applicants must • demonstrate adequate control of risks or that socio-economic benefits outweigh risks • develop substitution plans or inform on research to find alternatives • Restrictions can be applied to any substance

  37. Conclusion • Global Impact of REACh • US – TSCA Reform • China – ROHS • Taiwan • Canada The Fall-Out

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