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

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

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 of Chemicals 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 established to manage the system

6 REACh Timeline

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 risks to human health and the environment from the manufacture, import and use of chemicals within the EU

9 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 Impacts of REACh

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 ABC DEF GH This product contains 8 substances Therefore, this product will require 8 registrations

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

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 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 Pre-Registration

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

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 This is not a regulation that requires testing Proposals for testing….if appropriate 1.Provide the data available 2.Do the risk assessment 3.Determine data gaps 4.Drive testing requirements

24 Source:

25 Source: PhysicalTox/Ecotox Requirements All Substances >1 ton/year

26 Source: tons/year +

27 Source: tons/year +

28 Source: > 1000 tons/year +

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 Exposure Scenarios 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)

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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