Upload
fell
View
31
Download
0
Embed Size (px)
DESCRIPTION
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 - PowerPoint PPT Presentation
Citation preview
hw3/07 1
Occupational Hygiene and the Occupational Hygiene and the implementation of REACHimplementation of REACH
IOSH Exhibition & ConferenceIOSH Exhibition & Conference
Hugh WolfsonHugh Wolfson
Thanks to Andy Gillies for format and some of the content
hw3/07 hw3/07 BOHSBOHS 2
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
hw3/07 hw3/07 BOHSBOHS 3
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
hw3/07 hw3/07 BOHSBOHS 4
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
hw3/07 hw3/07 BOHSBOHS 5
The BOHS
The Society’s aim :
To help to reduce work-related ill-health
resulting in
A healthy worker in a healthyworking environment
www.bohs.org
hw3/07 hw3/07 BOHSBOHS 6
“they wouldn’t be allowed to sell it if it wasn’t safe”
Industrial products Commercial products Sale to the public
hw3/07 hw3/07 BOHSBOHS 7
“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 & labellingIn UK, HSWA 1974 section 6. CPL Regulations 197815 years after Directive 92/32/EEC (New Substances)In UK, NONS Regulations 1993Regulation (EC) No 1907/2006 of the European Parliament & Council and Directive 2006/121/EC
hw3/07 hw3/07 BOHSBOHS 8
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
hw3/07 hw3/07 BOHSBOHS 9
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
hw3/07 hw3/07 BOHSBOHS 10
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)
hw3/07 hw3/07 BOHSBOHS 11
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
hw3/07 hw3/07 BOHSBOHS 12
REACH & downstream usersMost of REACH is about manufacturers and importers to
EUDownstream 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
hw3/07 hw3/07 BOHSBOHS 13
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 manufactureFor 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)
hw3/07 hw3/07 BOHSBOHS 14
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
hw3/07 hw3/07 BOHSBOHS 15
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
hw3/07 hw3/07 BOHSBOHS 16
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
hw3/07 hw3/07 BOHSBOHS 17
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
hw3/07 hw3/07 BOHSBOHS 18
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
hw3/07 hw3/07 BOHSBOHS 19
Substance Evaluation
In addition, EU Member States & Commissioncan nominate and agree on annual list ofsubstances for in-depth evaluation
Competent Authorities carry out the evaluation
May lead to new control measures or to no further action
hw3/07 hw3/07 BOHSBOHS 20
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)
hw3/07 hw3/07 BOHSBOHS 21
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!
hw3/07 hw3/07 BOHSBOHS 22
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
hw3/07 hw3/07 BOHSBOHS 23
Communication up & down the supply chain
Multi-directional information flow Enhanced Safety Data Sheets Hazard data, exposure scenarios,
approved uses, restrictions on supply
CUSTOMERS(downstream users)
PRIMARY SUPPLIERS(manufacturers, importers)
CUSTOMERS/SUPPLIERS (formulators)
hw3/07 hw3/07 BOHSBOHS 24
Exposure scenariossome 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?
hw3/07 hw3/07 BOHSBOHS 25
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
hw3/07 hw3/07 BOHSBOHS 26
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
hw3/07 hw3/07 BOHSBOHS 27
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
hw3/07 hw3/07 BOHSBOHS 28
BOHS and REACH
REACH Steering Group reporting to Council
REACH pages on website
Workshops/Seminars planned for 2007
Statement of the value of OH
hw3/07 hw3/07 BOHSBOHS 29
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/reachCIA “REACH Ready” http://www.reachready.co.uk/British Occupational Hygiene Society http://www.bohs.org.uk/DEFRA http://www.defra.gov.uk/environment/chemicals/reach/HSE (Competent Authority) or phone helpdesk
http://www.hse.gov.uk/chemicals/reach/