Overview of the main EU legislations relevant for

Chemicals and Health & Safety at work,
a European perspective
Tony Musu, European Trade Union Institute
Kemiens Dag ‘16
Copenhagen, 23 November 2016
Overview
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Good and bad side of chemicals
Main EU legislations on chemicals
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Classification & Labelling – CLP regulation
REACH regulation
Occupational Safety & Health (OSH) legislation
Interface between these legislations
Do these EU legislations deliver & improve OSH?
Longer term perspectives
The good side of chemicals
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1,2 million workers in the EU chemical industry
3,6 million jobs in downstream sectors (building, textile,
automotive, electronic, etc...)
Turnover of the EU chemical industry:
€519 billion
per year
Source: Cefic, 2015
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Chemicals contribute to the EU economic prosperity in terms
of trade and jobs
The bad side of chemicals
Cancer is
the biggest
killer at work
in the EU-28
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102 500
deaths/year
due to workrelated
cancers
Source: Jukka Takala, ETUI, 2015
Negative impact on workers, employers and social-security
Annual Societal Costs
of work-related
cancers in the EU-28
€ 334 billion
(242-444)
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Source: RIVM, 2016
Main EU legislations on chemicals
Protection of
workers exposed to
Chemicals
Marketing/Use of
Chemicals
REACH
CLP
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Workers
Chemical Agents
Directive (98/24 EC)
Carcinogens &
Mutagens Directive
(2004/37 EC)
Classification, Labelling & Packaging (CLP) Regulation
Harmonised Classification and Labelling for carcinogens:
Category of carcinogen
Number of substances
1A
336
1B
681
2
198
Total
1215
C&L Notifications:
 covering ~123 000 individual substances
 of which ~ 3 000 self-classified as Carc. cat 1A or 1B or 2
 C&L inventory database available on ECHA website (including
substances in Annex VI of CLP with harmonized classification):
http://echa.europa.eu/web/guest/information-on-chemicals/clinventory-database
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REACH regulation (EU 1907/2006)
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Registration: Manufacturers and importers of chemicals > 1
tpa are required to register their substances to demonstrate
they can be used safely
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Evaluation of some substances by Member States /
European Chemicals Agency
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Authorisation only for substances of very high concern
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Restrictions when risks are unacceptable
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Timeline for REACH registration
~ 15 000 unique
substances
registered up to
Nov 2016
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Chemical Agents Directive (98/24/EC)
 Aim: protection of workers from risks related to chemicals at work
 Scope: all chemicals used at the workplace (regardless of
volume)
 Obligations for employers:
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Determine whether any hazardous chemical agents are present in the
workplace
Assess any risk to the H&S of workers arising from their use
If risks do exist, mandatory hierarchy of prevention and protection
measures (substitution > exposure reduction > protective equipmt)
Monitor the workers‘ health
Comply with existing Occupational Exposure Limit Values (OELVs);
up to now over 140 substances with indicative OELVs at EU level
Keep risk reduction measures up to date
Provide information and training to workers
Carcinogens Directive (2004/37/EC)
 Aim: protection of workers from risks related to carcinogens and
mutagens at work
 Scope: all carcinogens and mutagens (category 1A or 1B)
 Obligations for employers:
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Eliminate/Replace with a substance which is not or less dangerous
(mandatory if the alternative is available & regardless of cost)
If substitution is not technically feasible, use a closed system
Reduce workers' level of exposure as low as is technically possible
Comply with Binding Occupational Exposure Limit Values (BOELs)
Provide information and training to workers
Keep record of who is exposed and keep data available for authorities
Health surveillance of exposed workers
Occupational exposure limit values adopted at EU level
Under the Carcinogens & Mutagens Directive (2004/37/EC):
 Binding OELs: minimum level of protection across the EU
 Only 3 BOELs in 26 years (benzene, vinyl chloride, wood dust)
 New legislative proposal under discussion to have additional BOELs
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1st batch of 13 carcinogens proposed by EU Commission in May 2016
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2nd batch of 12 carcinogens by end of 2016 ?
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3rd batch of 25 carcinogens by 2020 ?
Under the Chemical Agents Directive (98/24/EEC):
 Indicative OELs: different levels of protection across MS possible
 Around 140 IOELs in 18 years
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0th list (indicative limit values, 91/322/EEC)
1st list (2000/39/EC)
2nd list (2006/15/EC)
3rd list (2009/161/EU)
4th list (draft adopted, under scrutiny)
5th list under development
First batch of new BOELs under EP/Council co-decision
Source: COM proposal 2016/0130 COD
Chemical Agents
Proposed BOEL
(8hr – TWA)
Nb of exposed
workers
0.1 mg/m3
5,300,000
3 mg/m3
3, 333,000
0.013 mg/m3
2,124,000
0.025 mg/m3
916,000
0.1 mg/m3
54,100
18 mg/m3 (5 ppm)
51,400
2.25 mg/m3 (1 ppm)
27,600
1.83 mg/m3 (1 ppm)
15,600
2.6 mg/m3
15,000
0.3 f/ml
10,000
0.5 mg/m3 (0.1 ppm)
5,500
1,2- Epoxypropane
(propylene oxide)
2.4 mg/m3 (1 ppm)
485-1,500
Bromoethylene (vinyl
bromide)
4.4 mg/m3 (1 ppm)
n/a
Respirable Crystalline Silica
(RCS)
Hardwood dusts
Hydrazine
Chromium (VI) compounds
Acrylamide
2-Nitropropane
1,3-Butadiene
Ethylene Oxide
Vinyl Chloride Monomer
(VCM)
Refractory Ceramic Fibres
(RCF)
o-Toluidine
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Interface between REACH & OSH legislation (1)
Marketing/Use of
Chemicals
REACH
CLP
Risk
assessment
+
Substitution
+
DNEL/OEL
Protection of
workers exposed to
Chemicals
Chemical Agents
Directive (98/24 EC)
Carcinogens &
Mutagens Directive
(2004/37 EC)
REACH, Art 4 (2) : This Regulation shall apply without prejudice to Dir 89/391, Dir
98/24, Dir 2004/37, [….]
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REACH applies without prejudice to OSH legislation
In practice, it means that employers still have to comply with
their obligations under worker protection legislation
(Chemical Agents Directive & Carcinogens Directive):
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Risk assessment at the workplace (can be combined with
REACH Chemical Safety Assessment)
Compliance with existing EU or national binding OELs
(regardless of DNELs)
Obligation to use a safer alternative to a carcinogen or a
mutagen when technically available (regardless of eventual
authorisations granted under REACH)
Obligation to provide information and training to workers
Interface between REACH & OSH legislation (2)
Ongoing debate about the interpretation of REACH Art 58(2):
Should the uses of a carcinogen be exempted from the authorisation
requirement under REACH when there is an EU OEL under the Chemical
Agents or the Carcinogens & Mutagens Directives ?
ETUI opinion:
 OELs useful tool to reduce exposure but not as effective as
substitution
 Neither the existing indicative nor binding OELs are appropriate
reasons to request authorisation exemptions under REACH Art 58(2):
 MS can deviate from EU IOELs and implement higher values
 BOELs do not guarantee adequate control (under OSH law
exposure minimisation is mandatory below BOEL)
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Do these legislations deliver & improve workers protection?
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The data generated by REACH/CLP foster a better knowledge of the
properties of chemicals, their effects on human health and ways of
reducing risk during their use
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REACH improves the transmission of such data along the entire supply
chain, thanks to better quality labelling and Safety Data Sheets
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Authorisation procedures in REACH are promoting the substitution of
the most harmful substances by safer alternatives & innovation (e.g.
substitution of arsenic trioxide in Venetian glass making SMEs)
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More BOELs under OSH legislation are essential to minimize workers
exposure to carcinogens & reduce future work-related cancers
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REACH & OSH legislation are complementary, compliance under
REACH brings benefits under OSH (and vice versa)
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Longer term perspectives
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Synergies between REACH and OSH need to be worked on and
developed further
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We need a public policy against work-related cancers
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Promoting substitution (public support & speed up SVHCs
inclusion in REACH Candidate list & Authorisation list)
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Collecting systematic data on exposures (Hazchem@work)
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Collecting reliable data on cancer and occupations
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Enforcement
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We need a consistent regulatory framework for Substances toxic for
reproduction & Endocrine Disruptor Chemicals
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We need to pay more attention to gender
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We need more training of workers & employers for effective use of data
generated by REACH/CLP and OELs established under OSH
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Industry needs to be convinced that the only way forward is safer
chemicals and products containing them
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Thank you for your attention !
More info available in ETUI publications (2016):
1) Eliminating occupational cancer in Europe and globally
http://www.etui.org/en/Publications2/Working-Papers/Eliminatingoccupational-cancer-in-Europe-and-globally
2) Cancer risks in the workplace, better regulation, stronger
protection
http://www.etui.org/fr/Publications2/Working-Papers/Cancer-risks-in-theworkplace-better-regulation-stronger-protection
3) Carcinogens that should be subject to binding limits on
workers exposure
http://www.etui.org/fr/Publications2/Rapports/Carcinogens-that-should-besubject-to-binding-limits-on-workers-exposure
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