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Occupational Hygiene and the implementation of REACH IOSH Exhibition & Conference Hugh Wolfson Thanks to Andy Gillies for format and some of the content. REACH Timetable. July 06: common position agreed between Parliament and Commission

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Occupational hygiene and the implementation of reach iosh exhibition conference hugh wolfson

Occupational Hygiene and the implementation of REACH

IOSH Exhibition & Conference

Hugh Wolfson

Thanks to Andy Gillies for format and some of the content

hw3/07


Reach timetable
REACH Timetable

  • July 06: common position agreed between Parliament and Commission

  • 18 Dec 06: adoption of Regulation by European parliament and EU Council

  • April 07: entry into force in Member States

  • 2007/08: European Chemical Agency start-up, Helsinki

  • 2008 – 2018: phase-in for existing substances

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Summary of presentation
Summary of Presentation

  • BOHS – an introduction

  • Substance information - existing situation

  • REACH - What’s new?

  • Format of REACH

  • Risk assessment under REACH

  • How does COSHH fit in?

  • Useful sources of information

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An introduction to bohs
An introduction to BOHS

  • A multidisciplinary, learned and professional society established in 1953 & merged with the British Institute of Occupational Hygienists (BIOH) in 2003

  • Faculty of Occupational Hygiene is its professional arm

  • The voice of the occupational hygiene community in the UK

  • An unrivalled source of information and expertise for members and non-members alike

  • An examining board, through the Faculty of Occupational Hygiene, awarding qualifications in occupational hygiene and allied subjects

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The bohs
The BOHS

The Society’s aim :

To help to reduce work-related ill-health

resulting in

A healthy worker in a healthy

working environment

www.bohs.org

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They wouldn t be allowed to sell it if it wasn t safe
“they wouldn’t be allowed to sell it if it wasn’t safe”

  • Industrial products

  • Commercial products

  • Sale to the public

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They wouldn t be allowed to sell it if it wasn t safe1
“they wouldn’t be allowed to sell it if it wasn’t safe”

Objective since the 1960’s - ensure enough safety information is available with products.

40 years after Directive 67/548/EEC on classification, packaging & labelling

In UK, HSWA 1974 section 6. CPL Regulations 1978

15 years after Directive 92/32/EEC (New Substances)

In UK, NONS Regulations 1993

Regulation (EC) No 1907/2006 of the European Parliament & Council and Directive 2006/121/EC

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Why is a new policy needed
Why is a safe”new policy needed?

  • The “old” system isn’t working

    • The 1992 Regulation excluded “existing substances” on the market before 1982 - 100,000+ substances, 99% (by volume) “sketchy” information on properties, uses & risks

  • NONS a drag on research and innovation

    • Information required for “new” substances far greater than for “existing”

  • Programme on Existing Chemicals (ESR) slow and costly – would take many years

  • REACH transfers main burden of proof from authorities to manufacturers and formulators

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Reach the new eu chemicals policy
REACH safe”the new EU chemicals policy

  • Information on all substances

  • Physicochemical properties relevant to safety and environmental risk

  • Sufficient toxicity by any relevant route

  • Typical exposure scenarios and exposure estimates

  • Risk management advice

  • Enhanced Safety Data Sheet

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Elements of reach
Elements of REACH safe”

  • Registration By industry

    • Document that human health & environmental risks are adequately controlled in all identified uses

  • EvaluationBy ECA or CA

    • Review of registration dossiers for compliance and animal testing proposals

  • AuthorisationBy ECA or CA

    • For substances of very high concern (CMR class 1 and 2, PBT, vPvB, others, e.g. endocrine disrupters)

  • RestrictionBy ECA or CA

    • for substances where risks are unacceptable

      ECA= new European Chemicals Agency, Helsinki

      CA= National Competent Authority (HSE in UK)

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Who has duties
Who has duties? safe”

Any company producing, importing, using or placing on to the EU market a substance, preparation or article.

  • Not just the Chemical Industry sector

  • Manufacturers, importers, formulators, suppliers

  • Estimated about 30,000 substances will be registered

  • Some exemptions:

    • e.g. radioactive substances, non-isolated intermediates, wastes, polymers, minerals, ores, LPG, biocides, medicinal products…

      Downstream users use the information for their local Risk Assessment

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Reach downstream users
REACH & downstream users safe”

Most of REACH is about manufacturers and importers to EU

Downstream users

  • have rights & obligations

  • can join a Substance Information Exchange forum during the registration process

  • have a right to request that suppliers’ CSA covers their use(s)

  • are obliged to use risk reduction measuresin the CSA

  • may have to do a local risk assessment for their particular use of the chemical if they do not disclose to the forum

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Registration timetable
Registration timetable safe”

All substances (approx 30,000) manufactured/imported over 1te/year (= existing substances, unless new registration pending)

  • For new substances, registration is essential before manufacture

  • For existing substances on EINECS and ELINCS, phase-in period over 11 years (to 2018)

  • Notify intention by 1/12/2008 (pre-registration)

  • Phase 1: >1000 tonnes/year + CMR, PBT (by 1/12/2010)

  • Phase 2: 100 – 1000 tonnes/year (by 1/6/2013)

  • Phase 3: 10 – 100 and 1 – 10 tonnes/year (by 1/6/2018)

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Registration
Registration safe”

“CMR, PBT” on previous slide means

  • Carcinogenic, mutagenic, or reproductive-toxic cat 1 or 2 above 1 tonne per year

  • Persistent bio-accumulative & toxic (Environmental risk) R 50-53 above 100 tonnes per year

  • Substances very persistent and very bio-accumulative (vPvB) included in above

  • Also substances of equivalent concern, eg endocrine disruptors

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Authorisation
Authorisation safe”

  • Authorisation required for all uses of substances of very high concern (eg CMR, PBT vPvB substances)

  • Authorisation granted if risks are under “adequate control”

  • adequate control allows authorities to prioritise action to haz subst that cannot be so controlled

  • If adequate control not possible, authorisation may still be granted on socio-economic grounds (i.e. no suitable safer alternative)

  • Companies required to make efforts to find safer alternative as part of their application for authorisation

  • Any substitute must be “feasible” and deliver lower overall risks

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Registration documents
Registration documents safe”

  • Technical dossier for all substances

    • Info. on properties, uses and classification

    • Animal test data or proposals for testing

    • Guidance on safe use

  • >10 tonnes/year Chemical Safety Report

    • Hazard classification

    • Chemical Safety Assessment (human health, safety & environmental risk assessment)

    • Exposure scenarios for all identified uses

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Reach and small medium establishments
REACH and safe”Small & Medium Establishments

20,000 of the 30,000 substances are supplied between 1 and 10 tonnes per year, mostly by SMEs

  • Special provisions in REACH to helpSMEs

  • Greatly reduced information requirement for 1 to 10 te/yr substances

  • 11 years (to June 2018) to register 1 to 10 te/yr substances

  • Reduced fees for SMEs in all areas of REACH

  • The Helsinki Chemical Safety Agency will take particular account of SMEs needs in preparing technical guidance and enforcement strategy

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Registration documents1
Registration documents safe”

  • Technical dossier and Chemical Safety Report

    • Direct to new European Chemical Agency in Helsinki

    • 100% check for completeness

    • 5% detailed verification

  • UK lead body in negotiation was DEFRA

  • UK Competent Authority is Health & Safety Executive

  • Enforcement in UK may lie with various authorities

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Substance evaluation
Substance Evaluation safe”

In addition, EU Member States & Commission

can nominate and agree on annual list of

substances for in-depth evaluation

Competent Authorities carry out the evaluation

May lead to new control measures or to no

further action

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Chemical safety assessment hazard assessment
Chemical Safety Assessment safe”hazard assessment

  • Human health

    • Evaluate data (animal data, epidemiology)

    • Decide on classification and labelling

    • Establish Derived No-Effect Level (DNEL)

  • Safety (physico-chemical)

    • Explosivity, flammability, oxidising potential

  • Environmental

    • Evaluate data, including PBT and vPvB assessment

    • Decide on classification and labelling

    • Establish Predicted No-Effect Concentration (PNEC)

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Chemical safety assessment exposure assessment
Chemical Safety Assessment safe”exposure assessment

Exposure scenarios

  • Cover manufacture and intended uses throughout substance life cycle, incl. waste disposal/recycling

  • Describe processes and tasks

  • Operational conditions

  • Risk management measures required

  • Included as an appendix to enhanced SDS

This is where Occupational Hygiene input is really needed!

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Human health risk characterisation
Human health safe”risk characterisation

  • For each exposure scenario; and

  • for each human population exposed (as workers, consumers, indirectly via the environment, or a combination)

  • Residual risk (after RMM implemented); and

  • comparison of exposure with relevant DNEL

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Communication up down the supply chain
Communication safe”up & down the supply chain

  • Multi-directional information flow

  • Enhanced Safety Data Sheets

  • Hazard data, exposure scenarios, approved uses, restrictions on supply

CUSTOMERS/SUPPLIERS (formulators)

PRIMARY SUPPLIERS

(manufacturers, importers)

CUSTOMERS

(downstream users)

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Exposure scenarios some questions
Exposure scenarios safe”some questions

  • Should ES be generic or specific?

  • Can COSHH Essentials help?

    And, based on the supplier’s scenarios…….

  • How does the ES fit with a COSHH risk  Downstream User assessment? What if the conclusions are different?

  • What if my use isn’t covered by an ES?  Downstream User

  • How can a supplier estimate the exposure levels at my site?  Downstream User

    Did the downstream user contribute to the forum?

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Risk management measures some questions
Risk Management Measures safe”some questions

  • Will control banding schemes like COSHH Essentials help?

  • A different mix of control options may achieve the same result; are both options valid?

  • How effective are RMM? Do I need to measure exposure? Downstream User

  • Do I have to use the recommended RMM from my supplier? Downstream User

  • What if different suppliers give conflicting recommendations? Downstream User

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Coshh and reach
COSHH and REACH safe”

Did the downstream user contribute to the forum?

And meanwhile…..

  • Until REACH deals with a product, COSHH is fully required, and downstream user contributes to forum

  • When REACH sheets established, am I using it exactly as described in the REACH sheet?

  • If not, full COSHH assessment needed (and possibly added to the data base for REACH)

  • The REACH sheets may specify quantity limits, or numerical ventilation provisions, so a use can easily be outside the exact specification

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Reach and occupational hygiene
REACH and safe”Occupational Hygiene

  • REACH is about protecting human health and the environment. Major role for H&S professionals

  • Multi-disciplinary team to address all the issues (commercial, technical, PR)

  • Occupational hygiene at the heart of REACH:

    • Exposure Scenarios

    • Risk Management Measures

    • Exposure monitoring and modelling

    • Data interpretation and use of exposure limits

    • Risk communication

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Bohs and reach
BOHS and REACH safe”

  • REACH Steering Group reporting to Council

  • REACH pages on website

  • Workshops/Seminars planned for 2007

  • Statement of the value of OH

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Useful information sources
Useful information sources safe”

Handy websites:

European Chemical Bureau http://ecb.jrc.it/REACH/

CEFIC http://www.cefic.be/

DG Enterprise http://ec.europa.eu/enterprise/reach

CIA “REACH Ready” http://www.reachready.co.uk/

British Occupational Hygiene Societyhttp://www.bohs.org.uk/

DEFRAhttp://www.defra.gov.uk/environment/chemicals/reach/

HSE (Competent Authority) or phone helpdesk http://www.hse.gov.uk/chemicals/reach/

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