Transcript The value of OH in the implementation of REACH

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 - 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
 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 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”

Industrial products

Commercial products

Sale to the public
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“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?
 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
 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/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
“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
 >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
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 Assessment
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
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
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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)
PRIMARY SUPPLIERS
(manufacturers, importers)
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CUSTOMERS
(downstream users)
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Exposure scenarios
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
 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 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
 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/reach
CIA “REACH Ready”
http://www.reachready.co.uk/
British Occupational Hygiene Society
DEFRA
http://www.bohs.org.uk/
http://www.defra.gov.uk/environment/chemicals/reach/
HSE (Competent Authority) or phone helpdesk
http://www.hse.gov.uk/chemicals/reach/
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