Hw3/071 Occupational Hygiene and the implementation of REACH IOSH Exhibition & Conference Hugh...

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


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


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


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


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

Industrial products

Commercial products

Sale to the public


“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


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


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


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)


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


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


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)


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


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


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


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


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


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


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)


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!


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


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)


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?


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


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


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


BOHS and REACH

REACH Steering Group reporting to Council

REACH pages on website

Workshops/Seminars planned for 2007

Statement of the value of OH


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 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/

http://ecb.jrc.it/REACH/





http://www.cefic.be/



http://www.reachready.co.uk/





http://www.bohs.org.uk/





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














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Hw3/071 Occupational Hygiene and the implementation of REACH IOSH Exhibition & Conference Hugh...

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