Occupational Hygiene and the implementation of REACH

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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

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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

• BOHS an introduction
• Substance information - existing situation
• REACH - Whats 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

• 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 Societys 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 wouldnt be allowed to sell it if it
wasnt safe

• Industrial products
• Commercial products
• Sale to the public

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they wouldnt be allowed to sell it if it
wasnt safe
Objective since the 1960s - 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?

• The old system isnt 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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REACHthe 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

• Registration By industry
• Document that human health environmental risks
  are adequately controlled in all identified uses
• Evaluation By ECA or CA
• Review of registration dossiers for compliance
  and animal testing proposals
• Authorisation By ECA or CA
• For substances of very high concern (CMR class 1
  and 2, PBT, vPvB, others, e.g. endocrine
  disrupters)
• Restriction By 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?

• 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

• 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 measures in 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

• All substances (approx 30,000) manufactured/import
  ed 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 gt1000 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

• 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 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

• Technical dossier for all substances
• Info. on properties, uses and classification
• Animal test data or proposals for testing
• Guidance on safe use
• gt10 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

• 20,000 of the 30,000 substances are supplied
  between 1 and 10 tonnes per year, mostly by SMEs
• Special provisions in REACH to help SMEs
• 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 documents

• 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

• 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 Assessmenthazard 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 Assessmentexposure 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

• 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

• Multi-directional information flow
• Enhanced Safety Data Sheets
• Hazard data, exposure scenarios, approved uses,
  restrictions on supply

CUSTOMERS/SUPPLIERS (formulators)
CUSTOMERS (downstream users)
PRIMARY SUPPLIERS (manufacturers, importers)
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Exposure scenariossome questions

• Should ES be generic or specific?
• Can COSHH Essentials help?
• And, based on the suppliers scenarios.
• How does the ES fit with a COSHH risk ?
  Downstream User assessment? What if the
  conclusions are different?
• What if my use isnt 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

• 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

• 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 is about protecting human health and the
  environment. Major role for HS 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

• 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

• Handy websites
• European Chemical Bureau http//ecb.jrc.it/REACH/
  
• CEFIC http//www.cefic.be/
• DG Enterprise http//ec.europa.eu/enterprise/re
  ach
• CIA REACH Ready http//www.reachready.co.uk/
• British Occupational Hygiene Society http//www.bo
  hs.org.uk/
• DEFRA http//www.defra.gov.uk/environment/chemic
  als/reach/
• HSE (Competent Authority) or phone helpdesk
  http//www.hse.gov.uk/chemicals/reach/