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

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REAChRegistration, Evaluation and Authorization of Chemicals

and Restriction!

Ohio Valley SOTWednesday, August 26, 2009

REACh: The New Toxicology Frontier

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Jennifer Galvin, PhD, DABT, CIHManager, Industrial Hygiene & ToxicologyConocoPhillips

Tracy Hammon, MS, DABTDirector, Product SafetyConocoPhillips

Presenters

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

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What is REACh?

• New EU Chemicals Regulation

• REACh : Registration, Evaluation, Authorization and Restriction of Chemicals

• REACh replaces 40 existing EU Chemical Regulations and Directives

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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

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REACh Timeline

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

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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.

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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

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• 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

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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

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No data = No market

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REACh is a substance-specific regulation

PRODUCT

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Product

A B C

D E F

G H

This product contains 8 substances

Therefore, this product will require 8

registrations

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

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• Burden of proof has shifted to industry

• Industry will have to prepare a comprehensive document including:– Hazards– Risks– Risk management

Impacts of REACh

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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

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Identified Uses

• Use of the substance must be included in the registration

• If substance is hazardous, exposures need to be assessed

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REACh Phases

Pre-Registration

SIEF Formation

Registration

Evaluation

Authorization

Restriction

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• 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

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• Substance Information Exchange Forum

• Purpose:– Data sharing (compulsory)– Agreement on Classification and Labeling

SIEF

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Registration

• Substances > 1 ton/year

• Develop Technical Dossier– Reduced requirements for intermediates

• Chemical Safety Assessment

• Classification

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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

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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

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

25Source: http://www.api.org/ehs/health/upload/API_REACH_Guide.pdf

Physical Tox/Ecotox Requirements

All Substances >1 ton/year

26Source: http://www.api.org/ehs/health/upload/API_REACH_Guide.pdf

10 - 100 tons/year+

27Source: http://www.api.org/ehs/health/upload/API_REACH_Guide.pdf

100 -100 - 1000 tons/year+

28Source: http://www.api.org/ehs/health/upload/API_REACH_Guide.pdf

> 1000 tons/year+

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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

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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)

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DNELs and PNECs

• DNEL: Derived No Effect Level

• PNEC: Predicted No Effect Concentration

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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)

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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

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Environmental Assessment

PBT Persistent, Bioaccumulative & Toxic

vPvB very Persistent & very Bioaccumulative

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Extended Safety Data Sheet (eSDS)

• Used to communicate hazard down the supply chain

• Increased requirements compared to current EU standard

• Exposure scenarios

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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

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Conclusion

• Global Impact of REACh– US – TSCA Reform– China – ROHS– Taiwan– Canada

The Fall-Out

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