Europaudvalget 2016
KOM (2016) 0248
Offentligt
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EUROPEAN
COMMISSION
Brussels, 13.5.2016
SWD(2016) 152 final
COMMISSION STAFF WORKING DOCUMENT
IMPACT ASSESSMENT
Accompanying the document
Proposal for a Directive of the European Parliament and of the Council
amending Directive 2004/37/EC on the protection of workers from the risks related to
exposure to carcinogens or mutagens at work
{COM(2016) 248 final}
{SWD(2016) 153 final}
EN
EN
 kom (2016) 0248 (forslag) - COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a Directive of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work
TABLE OF CONTENTS
INTRODUCTION ............................................................................................................... 7
1
WHAT IS THE PROBLEM AND WHY IS IT A PROBLEM? ................................. 8
1.1
Main drivers....................................................................................................... 9
1.1.1 Exposure of workers to carcinogens is significant .............................. 9
1.1.2 The Carcinogens and Mutagens Directive is outdated ...................... 10
1.1.3 Inadequate OELs at MS level have negative consequences for
workers and businesses across the EU .............................................. 16
Who is affected by the problem and how? ...................................................... 17
How would the problem evolve? ..................................................................... 19
Does the EU have the right to act? .................................................................. 21
Why is EU action needed and what is its added value? .................................. 21
What are the EU instruments relevant to dealing with carcinogens at the
workplace? ....................................................................................................... 22
How does this initiative relate to the envisaged review of the OSH acquis? .. 24
What are the general policy objectives? What are the more specific
objectives? ....................................................................................................... 25
Are these objectives consistent with other EU policies and with the Charter
for fundamental rights?.................................................................................... 26
Complementary measures ............................................................................... 26
Discarded options ............................................................................................ 27
Options retained for consideration .................................................................. 30
1.2
1.3
2
2.1
2.2
2.3
2.4
3
3.1
3.2
4
WHY SHOULD THE EU ACT? .............................................................................. 21
WHAT SHOULD BE ACHIEVED? ........................................................................ 25
WHAT ARE THE VARIOUS OPTIONS TO ACHIEVE THE OBJECTIVES?..... 26
4.1
4.2
4.3
5
WHAT ARE THE IMPACTS OF THE DIFFERENT POLICY OPTIONS AND
HOW DO THEY COMPARE? ................................................................................. 34
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
5.10
5.11
5.12
1,2 Epoxypropane ............................................................................................ 37
1,3 Butadiene ................................................................................................... 39
2 Nitropropane ................................................................................................. 42
Acrylamide ...................................................................................................... 44
Hardwood dust................................................................................................. 46
Chromium (VI) compounds ............................................................................ 49
Ethylene oxide (EO) ........................................................................................ 56
o-Toluidine
...................................................................................................... 58
Refractory Ceramic Fibres (RCF) ................................................................... 61
Respirable Crystalline Silica ........................................................................... 63
Vinyl Chloride Monomer (VCM) ................................................................... 70
Bromoethylene (vinyl bromide) ...................................................................... 72
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5.13 Hydrazine ........................................................................................................ 74
5.14 Summary of the retained options ..................................................................... 77
6
OVERALL IMPACT OF THE PACKAGE OF RETAINED OPTIONS ................ 78
6.1
6.2
Impact on workers ........................................................................................... 78
Impact on businesses ....................................................................................... 80
6.2.1 Impact on SMEs ................................................................................ 81
6.2.2 Impact on competition and competitiveness ..................................... 82
Impact on Member States/national authorities ................................................ 83
Impact on fundamental rights .......................................................................... 83
How does the retained option conform to the principles of subsidiarity and
proportionality given the size and nature of the identified problem? .............. 84
Monitoring arrangements ................................................................................ 84
Evaluation arrangements ................................................................................. 85
6.3
6.4
6.5
7
HOW WOULD ACTUAL IMPACTS BE MONITORED AND EVALUATED? .. 84
7.1
7.2
ANNEXES ........................................................................................................................ 87
8
ANNEX 1 – PROCEDURAL INFORMATION ...................................................... 87
8.1
8.2
8.3
8.4
Lead DG .......................................................................................................... 87
Consultation of the Regulatory Scrutiny Board (RSB) ................................... 87
Evidence used in the impact assessment ......................................................... 89
8.3.1 IARC Monographs ............................................................................ 89
External expertise ............................................................................................ 90
8.4.1 Use of scientific expertise / Commission expert groups / SCOEL ... 90
8.4.2 Studies performed by external consultants ........................................ 90
8.4.3 Study on chemical agents toxic to reproduction................................ 91
Social partner Consultation ............................................................................. 92
Other consultation of stakeholders .................................................................. 94
9.2.1 25 October 2006 - Workshop of setting OELs for Carcinogens ....... 94
9.2.2 EU-OSHA - Exploratory survey of Occupational Exposure Limits
(OELs) for Carcinogens, Mutagens and Reprotoxic chemical agents
(CMRs) at EU Member States level (published in September 2009) 94
9.2.3 Consultation of the tripartite Working Party "Chemicals at the
Workplace" (WPCs) of the ACSH .................................................... 95
9.2.4 September 2012 - Workshop in Berlin .............................................. 96
9.2.5 Consultation of the members of the ACSH on existing national
OELs for chemical agents subject to the amendments ...................... 96
9.2.6 Meetings with Industry and Workers representatives ....................... 97
9
ANNEX 2 - STAKEHOLDER CONSULTATION .................................................. 92
9.1
9.2
10
11
ANNEX 3 – WHO IS AFFECTED BY THE INITIATIVE AND HOW? ............... 98
ANNEX 4 – ANALYTICAL MODEL USED IN PREPARING THE IMPACT
ASSESSMENT ....................................................................................................... 100
11.1 Exposure estimation ...................................................................................... 100
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11.2 Health impact – methodology for estimation of the current cancer burden
(baseline) as compared with the policy intervention scenarios ..................... 101
11.3 Compliance costs ........................................................................................... 109
12
ANNEX 5 – DETAILED INFORMATION ON THE CARCINOGENICITY OF
THE CHEMICAL AGENTS................................................................................... 110
12.1 Respirable crystalline silica ........................................................................... 110
12.1.1 Identification.................................................................................... 110
12.1.2 Synonyms ........................................................................................ 110
12.1.3 Classification according to Regulation (EC) N° 1272/2008 with
regard to carcinogenicity: ................................................................ 111
12.1.4 Classification according to IARC .................................................... 111
12.1.5 Recommendation of SCOEL ........................................................... 111
12.2 Refractory ceramic fibres (RCFs) ................................................................. 112
12.2.1 Identification.................................................................................... 112
12.2.2 Synonyms ........................................................................................ 112
12.2.3 Classification according to Regulation (EC) N° 1272/2008 with
regard to carcinogenicity ................................................................. 112
12.2.4 Classification according to IARC .................................................... 113
12.2.5 Recommendation of SCOEL ........................................................... 113
12.3 Acrylamide .................................................................................................... 114
12.3.1 Identification.................................................................................... 114
12.3.2 Synonyms ........................................................................................ 114
12.3.3 Classification according to Regulation (EC) N° 1272/2008 with
regard to carcinogenicity: ................................................................ 114
12.3.4 Classification according to IARC .................................................... 114
12.3.5 Recommendation of SCOEL ........................................................... 114
12.4 Vinyl chloride monomer................................................................................ 116
12.4.1 Identification.................................................................................... 116
12.4.2 Synonyms: ....................................................................................... 116
12.4.3 Classification according to Regulation (EC) N° 1272/2008 with
regard to carcinogenicity: ................................................................ 116
12.4.4 Classification according to IARC .................................................... 116
12.4.5 Conclusions of SCOEL ................................................................... 116
12.5 Hardwood dust............................................................................................... 117
12.5.1 Identification.................................................................................... 117
12.5.2 Classification according to Regulation (EC) N° 1272/2008 with
regard to carcinogenicity: ................................................................ 117
12.5.3 Synonyms ........................................................................................ 117
12.5.4 Classification according to IARC .................................................... 117
12.5.5 Recommendations of SCOEL ......................................................... 117
12.6 Chromium (VI) compounds .......................................................................... 118
12.6.1 Identification.................................................................................... 118
12.6.2 Synonyms ........................................................................................ 119
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12.6.3 Classification according to Regulation (EC) N° 1272/2008 with
regard to carcinogenicity ................................................................. 119
12.6.4 Classification according to IARC .................................................... 119
12.6.5 Conclusion of SCOEL ..................................................................... 119
12.7 1-3- butadiene ................................................................................................ 123
12.7.1 Identification.................................................................................... 123
12.7.2 Synonyms ........................................................................................ 123
12.7.3 Classification according to Regulation (EC) N° 1272/2008 with
regard to carcinogenicity ................................................................. 123
12.7.4 Classification according to IARC .................................................... 123
12.7.5 Recommendation of SCOEL ........................................................... 124
12.8 Ethylene oxide ............................................................................................... 124
12.8.1 Identification.................................................................................... 124
12.8.2 Synonyms ........................................................................................ 124
12.8.3 Classification according to Regulation (EC) N° 1272/2008 with
regard to carcinogenicity ................................................................. 124
12.8.4 Classification according to IARC .................................................... 125
12.8.5 Conclusion of SCOEL ..................................................................... 125
12.9 1,2 Epoxypropane .......................................................................................... 126
12.9.1 Identification.................................................................................... 126
12.9.2 Synonyms ........................................................................................ 127
12.9.3 Classification according to Regulation (EC) N° 1272/2008 with
regard to carcinogenicity ................................................................. 127
12.9.4 Classification according to IARC .................................................... 127
12.9.5 Conclusion of SCOEL ..................................................................... 127
12.10
o-Toluidine
.................................................................................................... 128
12.10.1 Identification.................................................................................... 128
12.10.2 Synonyms ........................................................................................ 129
12.10.3 Classification according to Regulation (EC) N° 1272/2008 with
regard to carcinogenicity ................................................................. 129
12.10.4 Classification according to IARC .................................................... 129
12.10.5 Conclusion of SCOEL ..................................................................... 129
12.11 2 Nitropropane ............................................................................................... 129
12.11.1 Identification.................................................................................... 129
12.11.2 Synonyms ........................................................................................ 129
12.11.3 Classification according to Regulation (EC) N° 1272/2008 with
regard to carcinogenicity ................................................................. 129
12.11.4 Classification according to IARC .................................................... 129
12.11.5 Conclusion of SCOEL ..................................................................... 129
12.12 Bromoethylene .............................................................................................. 129
12.12.1 Identification.................................................................................... 129
12.12.2 Synonyms ........................................................................................ 129
12.12.3 Classification according to Regulation (EC) N° 1272/2008 with
regard to carcinogenicity ................................................................. 130
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12.12.4 Classification according to IARC .................................................... 130
12.12.5 Conclusion of SCOEL ..................................................................... 130
12.13 Hydrazine ...................................................................................................... 130
12.13.1 Identification.................................................................................... 130
12.13.2 Synonyms ........................................................................................ 130
12.13.3 Classification according to Regulation (EC) N° 1272/2008 with
regard to carcinogenicity ................................................................. 131
12.13.4 Classification according to IARC .................................................... 131
12.13.5 Conclusion of SCOEL ..................................................................... 131
13
14
ANNEX 6 - EXPOSURE LIMIT VALUES IN EU MEMBER STATES AND
SOME NON-EU COUNTRIES .............................................................................. 133
ANNEX 7 - RELEVANT EU LEGISLATION ...................................................... 139
14.1 Existing EU-OSH framework........................................................................ 139
14.1.1 Directive 89/391/EEC ..................................................................... 139
14.1.2 Directive 98/24/EC .......................................................................... 139
14.1.3 Directive 2004/37/EC ...................................................................... 140
14.1.4 Directive 2009/148/EC .................................................................... 140
14.2 Internal Market legislation ............................................................................ 140
14.2.1 REACH Regulation ......................................................................... 140
14.2.2 CLP Regulation ............................................................................... 142
14.2.3 Comparison of high level CMD and REACH provisions in relation
to occupational carcinogens ............................................................ 143
15
ANNEX 8 – GENERAL INFORMATION ABOUT THE CLASSIFICATION
SYSTEMS REFERRED TO IN THE DOCUMENT.............................................. 145
15.1 Carcinogens ................................................................................................... 145
15.1.1 Classification according to the CLP Regulation ............................. 145
15.1.2 Classification according to IARC .................................................... 146
16
ANNEX 9 – ADDITIONAL GRAPHICAL MATERIAL...................................... 147
16.1 1,2 Epoxypropane .......................................................................................... 147
16.2 1,3 Butadiene ................................................................................................. 147
16.3 2 Nitropropane ............................................................................................... 148
16.4 Acrylamide .................................................................................................... 149
16.5 Hardwood dust............................................................................................... 151
16.6 Chromium VI................................................................................................. 152
16.7 Ethylene oxide ............................................................................................... 153
16.8
o-Toluidine
.................................................................................................... 155
16.9 Refractory Ceramic Fibres (RCF) ................................................................. 156
16.10 Respirable Crystalline Silica (RCS) .............................................................. 156
16.11 Vinyl Chloride Monomer (VCM) ................................................................. 158
16.12 Bromoethylene (vinyl bromide) .................................................................... 158
16.13 Hydrazine ...................................................................................................... 159
17
ANNEX 10 – ABBREVIATIONS USED .............................................................. 160
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I
NTRODUCTION
Exposure to some chemical agents in the workplace can cause cancer. To ensure that workers
are protected against such risks, the EU has adopted the Carcinogens and Mutagens Directive
(CMD)
1
. The Directive sets out steps to be taken to eliminate or limit exposure to carcinogenic
chemical agents. It establishes under Article 16 that the Council shall set out limit values over
which exposure is not allowed, on the basis of available scientific and technical data, in respect
of all those carcinogens for which this is possible.
The limit values create useful benchmarks for employers and enforcement authorities to decide
on which protection measures should be taken. This adds to the general obligation in the CMD
for employers to eliminate exposure of workers to carcinogenic substances and makes more
explicit the general requirement of the over-arching Occupational Safety Health (OSH)
Framework Directive
2
to eliminate all risks.
In order to fulfil the obligation under Article 16 of the Directive to set limit values in respect of
all those carcinogens for which this is possible, the Commission has initiated a scientific and
economic assessment of 25 priority chemical agents which have been classified as carcinogens
by national and/or international authorities and institutions. In the EU around 20 million workers
are exposed to at least one of these chemical agents. Following discussions by scientists,
employers, workers, Member States' representatives and labour inspectors in a series of health
and safety committees, suggestions for limit values have been developed.
Introducing these limit values in the Directive would provide employers, workers and
enforcement bodies with an objective measure to help to ensure that the general principles of the
Directive are complied with. This should contribute to a reduction in exposure to these priority
carcinogens with a consequential reduction in potential new cases of occupational cancer in the
affected workers. It is estimated that under the baseline the considered carcinogens will lead to
over 460,000 deaths caused by occupational exposure. Introduction of the proposed limit values
could make it possible to avoid some 100,000 of them in the forthcoming 50 years
3
. These
figures are based on estimations made in a study contracted by the Commission
4
.
In certain cases introduction of limit values would impose some costs on enterprises to take the
necessary protective measures such as installing ventilation systems and acquiring protective
equipment where they do not exist. On the other hand, establishing compliance benchmarks for
exposure control through these limit values would mean that businesses have clear minimum
standards applied across the internal market.
The calculations underpinning the analysis of costs and benefit for limit values are complicated
due to a number of factors, not least that the time between exposure to a carcinogen and the
onset of the disease can be up to 50 years. Calculating costs and benefits over such a long period
is challenging and based on a number of assumptions regarding gradually reduced exposure in
the baseline, production methods, medical knowledge etc.
1
Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of
workers from the risks related to exposure to carcinogens or mutagens at work (sixth individual Directive within
the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 158, 30.4.2004, p. 50)
Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in
the safety and health of workers at work.
Deaths avoided mainly in relation to the following chemical agents: Chromium VI - 1670; Refractory Ceramic
Fibres - 50; Respirable Crystalline Silica - 98,670. The analytical model used to arrive at these figures can be
found in Annex 4.
IOM Research Project P937/99, May 2011 – Health, social-economic and environmental aspects of possible
amendments to the EU Directive on the protection of workers from the risks related to exposure to carcinogens
and mutagens at work.
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3
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This impact assessment looks at the costs and benefits of introducing limit values for 13 of the
25 priority chemical agents. For the remaining chemical agents there is additional analysis of
costs and benefits to be done. This analysis will be presented in a further impact assessment.
1
W
HAT IS THE PROBLEM AND WHY IS IT A PROBLEM
?
According to the World Health Organisation (WHO), cancer is the second largest cause of death
in most developed countries.
5
In the European Union in 2013 there were approximately 1.314
mln cancer deaths. In 2012, an estimated 2.7 mln new cases of cancer were diagnosed in EU
Member States
6
, and 7.2 mln people were living with cancer (within 5 years of diagnosis)
7,8
.
Cancer is the first cause of work-related deaths in the EU (see Figure 1 below). 53% of annual
occupational deaths are attributed to cancer, compared to 28% for circulatory diseases and 6%
for respiratory diseases.
The number of deaths attributed to occupational cancer in the EU is reported to be 102,500 for
2011
9
.
Figure 1. Deaths attributed to work
communicable
diseases; 2,5%
other; 4,2%
mental disorders;
5,7%
respiratory
diseases; 6,0%
circulatory
diseases; 28,0%
Cancers; 53,0%
Source: WSH Institute 2014
5
6
7
8
Are the number of cancer cases increasing or decreasing in the world?,
World Health Organisation, April 2008
European Commission, Health at a glance 2014.
IARC, cancer fact sheets, http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx
Data for more recent years (2013,2014) are available only for a limited number of Member States, which does
not allow compilation of estimates for EU totals (according to Eurostat's guidance an estimate for an EU total
can be compiled only if the available figures cover 90% of the EU population).
Eliminating occupational cancer in Europe and Globally,
Takala, J, European Trade Union Institute, October
2015.
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Figure 2. Problem tree
Regulatory drivers:
Outdated EU legal framework for
carcinogens
Inadequate national OELs
PROBLEM
DRIVERS
Market driver:
Exposure of workers to carcinogens is
significant.
Cancer is the first cause of work-related deaths
CONSEQUENCES
For businesses:
Higher costs
(absenteeism, staff
replacement, higher
wages)
Reduced staff
productivity
Distorted competition
For Member States:
Higher social
security costs
Forgone tax
revenue
For workers:
Reduced quality of
life
Premature deaths
Higher health related
costs
1.1
1.1.1
Main drivers
Exposure of workers to carcinogens is significant
Different forms of cancer may be initiated or promoted by the exposure to carcinogenic and/or
mutagenic chemical agents at work
10
. In the EU 32 mln workers (23% of people employed)
were exposed to chemical agents classified as carcinogenic or probably carcinogenic to humans
by the WHO's International Agency for Research on Cancer (IARC) in 1990-93.
11
In France,
estimates from 2010 suggest that approximately 2 mln workers were exposed to at least one
carcinogen in their most recent week of activity at work, approximately 10% of the working
population. Workers in maintenance activities (42.6% exposed) and young workers (below 25
years of age) (15.2% exposed) were found to be particularly exposed, and many of them to
several carcinogens, mutagens and reprotoxins at the same time
12
.
According to the EU Classification, Labelling and Packaging Regulation (CLP)
13
, 1017
chemical agents (and groups of chemical agents) have received mandatory 'harmonised
classification' as 'category 1' carcinogens, attracting the label hazard statement 'may cause
cancer'. If the assessment was based primarily on human evidence category 1A is assigned (this
10
Workplace factors other than chemical agents might contribute to development of cancers (e.g. ultraviolet
radiation, infections, etc.). The scope of the Carcinogens and Mutagens Directive is however limited to chemical
agents.
Occupational exposure to carcinogens in the European Union,
Kauppinen, T. et al., Occup Environ Med, 2000,
57: 10-18.
Les expositions aux cancérogènes, mutagènes et reprotoxiques. Un zoom sur huit produits chimiques. Dares
2015 (see https://osha.europa.eu/en/oshnews/fr-over-2-mln-people-exposed-least-one-carcinogen-mutagen-or-
reprotoxicant-2010)
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on
classification, labelling and packaging of chemical substances and mixtures
9
11
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is the case for 336 agents), with category 1B assigned where animal evidence is primarily used
(681 agents are in this category). Chemicals suspected to cause cancer in humans but where data
is not sufficiently convincing for category 1 may be classified as 'category 2 carcinogens'.
IARC has identified nearly 500 agents that are carcinogenic for humans (Group 1; 118 agents),
probably carcinogenic to humans (Group 2A; 75) or possibly carcinogenic to humans (Group
2B; 288).
14
Table 1 in the section 1.1.2. presents estimates of numbers of workers exposed to the
carcinogens covered in this report. The numbers of exposed workers vary significantly across
the agents. Some of the carcinogens, like Respirable Crystalline Silica (RCS), chromium (VI)
compounds, hardwood dust or hydrazine, affect very high numbers of workers. For some others
there are indications that use patterns may be lower. However, the agents are themselves
important – for example the ratio between the number of exposed workers and cancer cases may
be higher for some of these chemical agents. It is also important to recognise that use patterns
change rapidly and for complex reasons. Market forces such as raw material and energy prices,
developing technology, as well as regulatory changes can drive increases in use which are not
easy to predict. This is the case for example for acrylamide, used for production of
polyacrylamide, which is a growing sector.
1.1.2
The Carcinogens and Mutagens Directive is outdated
The current rules
While cancer is a complex disease and some causal factors are difficult to identify, it is clear
that cancers caused by work can be prevented by reducing or eliminating the exposures leading
to the disease.
The EU principles of worker protection from carcinogens are laid out in the over-arching
Occupational Safety Health (OSH) Framework Directive 89/391/EEC and those Directives
specifically dealing with chemicals risks – notably the Chemical Agents Directive (CAD) and
the Carcinogens and Mutagens Directive (CMD). The latter includes a commitment to set
Occupational Exposure Limit (OELs) values for all carcinogens or mutagens for which this is
possible.
15
Under the OSH framework risks to the safety and health of workers shall be eliminated or
reduced to a minimum. In the case of carcinogens, CMD sets a number of concrete provisions.
Employers must identify and assess risks to workers associated with exposure to specific
carcinogens (and mutagens), and must prevent exposure where risks occur. Substitution to a
non- or less-hazardous process or chemical agent is required where this is technically possible.
Where carcinogens cannot be substituted they must, so far as is technically possible, be
manufactured and used in a closed system to prevent exposure.
Where this is not technically possible either, worker exposure must otherwise be reduced to as
low a level as is technically possible. This is the so-called minimisation obligation under Article
5 of the CMD. This is a more strict standard than for other hazardous chemicals, where the duty
to control risks is always qualified by an assessment of risk by the employer.
14
Monographs on the evaluation of carcinogenic risk to humans, International Agency for Research on Cancer,
WHO.
OEL values are stated as quantitative figures representing the airborne concentration of the chemical agent in
question as a time weighted average over 8 hours. Concentrations expressed as mg/m
3
values indicate
milligrams of chemical agent per cubic metre of air at 20 °C and 101,3 kPa (760 mm mercury pressure). To
note, in a strict sense when referring to limits set in the CMD, the term 'limit value' should be used – often
expressed as a 'binding occupational exposure limit value' or 'BOELV'. In parallel, the term OEL is used for
example when referring to limits set at the national level. In order to simplify this text the term OEL is used to
refer to any occupational exposure limit (value) whether set in EU or national legislation.
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CMD provisions apply to any chemical agent which is classified as a 'Category 1' carcinogen (or
mutagen) under the EU CLP Regulation, thus to the 1017 substances above mentioned. They
also apply – in full – to any chemical agent which would meet the criteria for such classification
if it were placed on the EU market, which means that employers have a responsibility to identify
occupational carcinogens to which workers may be exposed but which have not already been
classified by their suppliers.
This is the case for example of the so-called 'process-generated substances' (PGS). These are
hazardous 'chemical agents' such as dust, fumes, and gases which may, for example, be
generated during the combustion of fuel by diesel engines used for mining, or as by-products
during production processes, etc.
PGS have the potential to be major sources of occupational exposure to chemical carcinogens –
but because they are never 'placed on the market' in the EU they are never subject to the CLP
classification system. This can be confusing for employers, workers, and enforcers. It is clear
that CMD controls apply to workplace carcinogens – but it may in some cases be unclear
whether a 'process generated substance' is hazardous in this way.
CMD therefore also includes a list of identified process generated substances in its Annex I. The
aim of this list is to clarify for workers, employers, and enforcers whether a given chemical
agent, if it has not otherwise been classified according to CLP, is in scope of the CMD controls.
Currently, Annex I has 5 entries:
1.
Manufacture of auramine.
2.
Work involving exposure to polycyclic aromatic hydrocarbons present in coal soot, coal
tar or coal pitch.
3.
Work involving exposure to dusts, fumes and sprays produced during the roasting and
electro-refining of cupro-nickel mattes.
4.
Strong acid process in the manufacture of isopropyl alcohol.
5. Work involving exposure to hardwood dusts.
CMD also provides that, in any case, exposure of workers must be kept below 'binding
occupational exposure limit values' (OELs).
An OEL addresses the inhalation route of exposure, describing a maximum airborne
concentration level for a given chemical agent above which workers should not be exposed, on
average, during a defined time period.
OELs can further be annotated with appropriate indications of additional non-inhalation hazard
such as, for example, a 'skin' notation where the dermal route of exposure is scientifically
considered to be relevant.
OELs are set in Annex III of the CMD for some chemical agents which fall under the scope of
the Directive - including some of the PGSs identified in Annex I.
16
Annex III currently includes
limit values for occupational exposure for three agents: benzene, vinyl chloride monomer
(VCM) and hardwood dusts.
As explained above, employers must prevent or minimise exposure to occupational carcinogens
where risks occur. The principle of minimisation of the exposure is stated in article 5.3 of the
16
Setting an OEL is not always possible. For PGSs specifically, this could be related for example to the fact that
some of them are a complex mixture of carcinogenic substances, the mixture can be variable as regards the
precise composition and relative quantities of each of these substances. Therefore, it would be necessary to set
individual OELs for every component substance and to carry out sampling and analysis for each of them for
compliance purposes, which in practice would be difficult to do. In other cases, an OEL, which is to protect
against risks to health arising from inhalation of the substance, would not be appropriate the critical route of
exposure is not by inhalation but instead is by direct absorption through the skin (dermal exposure).
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CMD: 'the employer shall ensure that the level of exposure of workers is reduced to as low a
level as is technically possible'.
CMD OELs do not directly affect in theory the legal standard of control, which is in any case
for minimised exposure. In practice, however, the existence of an OEL provides a clear
benchmark that enables professionals to 'operationalise' the concept of minimised exposure,
thereby allowing them to easily determine the level to which the exposure should at least be
reduced.
From a more general perspective, OELs promote consistency by defining a 'level playing field'
for all users and a common objective for employers, workers and enforcement authorities. This
leads to a more efficient system of protection of workers' health.
It should be added that for most carcinogens and mutagens substances it is not possible to
identify a safe threshold below which the adverse health effects of exposure can be prevented
completely. The genotoxic mode of action of a substance entails that extremely low amounts of
a substance reaching the appropriate target (deoxyribonucleic acid or DNA) may initiate a
tumoral process
17
. Therefore, although for a genotoxic carcinogenic substance the risk cannot be
eliminated by setting an OEL, the probability that the effects occur can be lowered by
complying with a limit value. In terms of population, it can be said that the percentage of
workers affected by a cancer would be lower if the level of exposure is kept lower. This is the
reason why the minimisation of the exposure is a basic principle set up in CMD and why OELs
for carcinogenic substances are useful to prevent occupational cancer although for most
substances (non-threshold substances) there will always be a residual risk that could only be
reduced to zero by fully eliminating the presence/use of the substance in the workplace.
The CMD includes a general obligation for the employer to reduce the use of a chemical
carcinogen by, where technically possible, substituting to a less- or non-hazardous chemical
agent or process and, when requested to do so by the relevant authorities, submit the findings of
the associated investigations (CMD Article 4). The adoption of an OEL does not replace this
obligation.
The practical implementation of effective chemical substitution policies can deliver significant
benefits in terms of protecting the health and safety of workers.
Effective substitution is associated with a number of issues that are not always easy to evaluate
in order to facilitate the decision making process. It requires judgment to take account of
workers health and safety protection, process performance, the ease and cost of introducing
substitutes, environmental considerations and other factors in making a substitution choice.
Several approaches to substitution exist ranging from ad-hoc approaches to methods that are
defined, structured and documented. Less sophisticated substitution approaches may be more
suitable for smaller companies compared to larger better resourced organisations that have a
high level of technical expertise. To make substitution happen in practice requires a raised
awareness and involvement of all stakeholders.
The European Commission recognises the multi-attribute challenges that substitution presents to
individual employers and has published guidance to analyse and evaluate the practical
implementation of the principle of substitution of hazardous chemicals at the workplace with a
view to further enhance the protection of workers health and safety while taking into account the
above-mentioned factors.
18
17
This constitutes an important difference between carcinogenic effects and non-carcinogenic effects modes of
action, and it is one of the reasons, together with the severity of effects, that justify the existence of a specific
piece of legislation to protect workers (CMD) in comparison with other chemicals (CAD).
Minimising chemical risk to workers’ health and safety through substitution,
European Commission, July 2012,
12
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Annex I and III of the CMD are not in line with scientific evidence.
Firstly, there is important scientific evidence that the process-generated substance, respirable
crystalline silica, is carcinogenic
19
.
Secondly, two of the three current OELs defined in Annex III of the CMD, namely on 'work
involving exposure to hardwood dust' and vinyl chloride monomer are estimated to be too high
to adequately protect workers. Available scientific evidence points also to the need to complete
Annex III with OELs for several additional agents
20
.
As has been established, over 1000 chemical substances have been given 'harmonised'
classification as category 1 carcinogens under the CLP Regulation. Many of these chemical
agents are, however, almost certainly no longer used in Europe, having been superseded or
otherwise phased out of use – and fewer again will be present as occupational carcinogens
today. There are, however, many chemical carcinogens which are known to both be in current
use in Europe and which pose a risk to workers.
The Commission initiated work to amend or establish OELs for 25 priority chemical agents in
2004.
21
The selection of these agents took into account the views of stakeholders, principally at
MS authority level as communicated to the Commission during exchanges of views including at
the meetings of the National Experts Working Group on OELs. In addition for the two of the
three existing EU OELs (hardwood dust and VCM) the Scientific Committee on Occupational
Exposure Limits (SCOEL
22
) had adopted new/revised Recommendations, in 2003 and 2004
respectively that indicated a need to consider the revision of the existing OELs.
Among hundreds of carcinogenic substances, these 25 chemical agents are considered as a
priority for protection of workers and the choice is quite consistent with subsequent third party
priority lists. For example, of the 25 chemical agents, 11 are listed among the 30 highest
priority substances in a report published by the Netherlands National Institute for Public Health
and the Environment
23
, and 21 were included in a list of 65 candidates for OELs published by
European Trade Union Congress in 2015.
24
As shown by a study contracted by the Commission
to evaluate impacts of introducing OELs for those 25 chemical agents
25
(later on referred to as
the IOM study), at least 20 million EU workers are considered to be potentially exposed to one
or several of them.
19
The term 'respirable crystalline silica' or 'RCS', as used throughout this report when referring to the chemical
agent for which an Annex I entry may be proposed, should be taken to mean 'the respirable fraction of crystalline
silica dust generated by a work process'.
SCOEL has submitted recommendations for setting new OELs on all the other chemical agents covered by this
report except for two (o-toluidine and 2-nitropropane). A summary of SCOEL conclusions is provided in Annex
5.
Because of data challenges which will be explained later in this document, there exists no decisive exposure
evidence base for prioritising occupational carcinogens for which OELs should be established.
SCOEL aims to establish an exposure threshold for a given chemical agent below which adverse effects to
human health are unlikely to occur (health-based limit values). For carcinogens, such health-based limit values
can only be derived in very few cases. When no health-based limit value can be set, SCOEL instead estimates
the residual risk of developing cancer for workers at different exposure levels. In addition, SCOEL
recommendations also address scientific/technical feasibility of monitoring exposure including the availability of
suitable measurement techniques.
Identifying prevalent carcinogens at the workplace in Europe,
RIVM, 2015
List of OEL candidates, European Trade Union Congress, 2015. To note, this list of 65 chemical agents also
includes three for which OELs already exist either in the CMD (benzene), in the Chemical Agents Directive
98/24/EC (inorganic lead and its compounds), or in the separate Directive 2009/148/EC (asbestos).
IOM Research Project P937/99, May 2011 – Health, social-economic and environmental aspects of possible
amendments to the EU Directive on the protection of workers from the risks related to exposure to carcinogens
and mutagens at work
13
20
21
22
23
24
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This report deals with 13 chemical agents from the original 25 for which data is available
26
.
For the second group of 12 chemical agents, further information gathering and consideration is
necessary.
27
In the course of the preparatory work, the Commission considered also the possibility to extend
the scope of CMD to apply also to chemical agents which are toxic for reproduction. However,
as set out in more detail in annexes 1 and 2 (sections 8.4.3, 9.1, and 9.2.2-3) several policy and
technical factors, including the already-adequate scope of the CAD, resulted in a conclusion that
there is no need for further action at this time.
The first 13 chemical agents and their key characteristics are presented in the Table 1 below.
Table 1. Sectors, types of cancer caused and estimated exposure levels for 13 chemical agents under
consideration
28
Chemical
Classification
agents,
CLP
30
IARC
including CAS
numbers where
relevant
1,2
Epoxypropane
75-56-9
1B
2B
Relevant sectors
Types of cancer
caused/other
illnesses
No. of
exposed
workers
29
Chemical manufacture;
synthetic lubricants, oil field
drilling chemicals; polyurethane
systems.
Lymphopoietic
cancer,
haematopoietic
cancer, increased
leukaemia risk
485-1,500
1,3 Butadiene
106-99-0
2 Nitropropane
79-46-9
Acrylamide
79-06-1
1A
1
Manufacture of refined
Lymphohaema-
petroleum products,
topoietic cancer
manufacture of rubber products
Manufacture of basic chemicals, Liver tumours
31
manufacture of aircraft and
spacecraft (downstream use)
Manufacture of chemicals and Pancreatic cancer
chemical products, education,
research and development, other
business activities, health and
social work, public
administration and defence.
Chemicals and allied
production; rubber and plastic
production; leather and leather
production; fabricated metal
production for wholesale trade
Liver cancer
27,600
1B
2B
51,400
1B
2A
54,100
Bromoethylene 1B
593-60-2
2A
n/a
26
27
See point 4.2 for a description of the identification process.
For these chemical agents it is necessary to further consider, for example, the remaining exposure situation for a
chemical agent which is already subject to an international convention effectively banning sale and use, and to
ascertain whether the definition for certain PGSs is legally robust.
Source: IOM Research Project P937/99, May 2011 – Health, social-economic and environmental aspects of
possible amendments to the EU Directive on the protection of workers from the risks related to exposure to
carcinogens and mutagens at work. This report is the source of all figures concerning the 13 chemical agents in
the report , unless otherwise specified.
Estimates, rounded down
Harmonised (i.e. mandatory) CLP classifications for carcinogenicity
According to animal toxicity studies (no epidemiological evidence).
14
28
29
30
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Chromium (VI) 1B
compounds
1
Production and use of
Lung cancer and
chromium-containing pigments, sinonasal cancer
paints and metal (conversion)
coatings. In terms of
downstream use, chromate
compounds, including barium
chromate, zinc chromate, and
calcium chromate, may be used
as basic primers and top coats
in the aerospace sector.
Extraction of crude petroleum Leukaemia
and natural gas; service
activities incidental to oil and
gas extraction; Manufacture of
food products, textiles,
chemicals, chemical products,
medical, precision and optical
instruments, watches, clocks;
Hospital and Industrial
sterilization; R&D; Public
Administration and Defence;
Education; Health and Social
Work
Wood working industry,
furniture manufacture sectors
and construction.
Chemical blowing agents;
agricultural pesticides; water
treatment
Manufacture of chemicals,
chemical products and man-
made fibres; Manufacture of
rubber products; Research and
development; Public
administration and defence;
education; health and social
work.
Sinonasal and
nasopharyngeal
cancers
916,000
32
Ethylene Oxide 1B
75-21-8
1
15,600
Hardwood dust
n/a
1
3, 333,000
Hydrazine
302-01-2
o-Toluidine
95-53-4
1B
2B
Lung and colorectal 2,124,000
cancer
Bladder cancer
5,500
1B
1
Respirable
Crystalline
Silica
(RCS)
Refractory
Ceramic Fibres
(RCF)
Vinyl Chloride
Monomer
32
33
n/a
1
Mining, glass manufacturing, Lung cancer,
construction and electricity, gas, silicosis
steam and hot water supply
industries.
Manufacturing (fibre
production, finishing,
installation, removal, assembly
operations, mixing/forming)
Manufacture of chemicals and
chemical products (VCM and
5,300,000
33
1B
2B
Adverse respiratory 10,000
effects, skin and eye
irritation; possibly
lung cancers
Angiosarcoma,
hepatocellular
15,000
1A
1
This figure is an estimate for all chromium VI compounds.
According to the IOM Research Project P937/99 'Health, social-economic and environmental aspects of possible
amendments to the EU Directive on the protection of workers from the risks related to exposure to carcinogens
and mutagens at work' published in May 2011 (p. 21) 'approximately 5,3mln. employees in the EU were
potentially exposed to RCS in 2006. Over 4 million of these workers are in the construction sector'.
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(VCM)
75-01-4
PVC production)
carcinomas
Adoption of the proposal to review Annexes I and III of the CMD with regard to a first batch of
carcinogens is envisaged for the first semester of 2016 in the Commission Work Programme.
Preparatory work has been going on since 2004, and representatives of Member States
authorities, employers' and workers' representative bodies within the framework of the tri-partite
Advisory Committee on Safety and Health (ACSH) strongly anticipate a Commission proposal.
In its Resolution of 25 November 2015 on the EU Strategic Framework on Health and Safety at
Work 2014-2020, the European Parliament 'firmly reiterates its call on the Commission to
present a proposal for a revision of Directive 2004/37/EC on the basis of scientific evidence
adding more binding occupational exposure limit values where necessary'.
34
1.1.3 Inadequate OELs at MS level have negative consequences for workers and businesses
across the EU
Under the CMD, Member States may adopt a national limit value that is lower (i.e. more
stringent) than the EU value. They can also adopt OELs for chemical agents for which it has not
been done at EU level. This is consistent with the ultimate objective of the Directive, which is to
minimise the level of exposure, as it allows for further advances to take place at Member State's
level in light of country-specific and industry-specific developments.
One or more Member States have indeed set limit values for all of the agents covered in this IA.
For example, most Member States have set limits for ethylene oxide and acrylamide. Less than
half have done so for bromoethylene or
o-toluidine.
In the absence of EU OELs, national scientific committees and/or other national bodies need to
independently evaluate each carcinogen leading to a repetition of identical tasks in several
Member States.
While the possibility to set national OELs is in line with the CMD provisions, in practice, where
national OELs exist they vary considerably in some cases, leading to significantly different
levels of protection. For example for 1,3 butadiene, the values range from 4.5 to 100 mg/m
3
. For
ethylene oxide, values range from 0.84 to 90 mg/m
3
. A comprehensive overview of the national
OELs for each of the chemical agents covered in this report is provided in Annex 9 and a
summary overview table can be found in Annex 6.
The lack of national OELs for some chemical agents, and the high levels of others, not only
leads to inadequate protection for EU workers but can also have negative consequences for the
internal market, because businesses located in Member States with less stringent levels (i.e. with
absent or higher OELs) would benefit from an undue competitive advantage. For example, 1,2-
epoxypropane producers in FR and RO have to comply with exposure limits 10 times higher
(i.e. less constraining) than in other producing countries, such as DE, ES and NL (50 mg/m
3
vs 5
mg/m
3
). Even if the minimisation obligation applies to all employers in Europe, these undue
competitive advantages would continue to exist in the absence of an EU-wide OEL, because
both employers and surveillance authorities would need to rely on their own judgement on what
is "technically possible".
Divergence in national OELs may be partially due to differences in the methodology used for
the scientific evaluation of a carcinogen by the respective national limit setting committees.
More recently established national OELs may be different (for example more stringent) than
those set earlier as a result of improved scientific understanding or availability of data. Further,
34
http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+TA+P8-TA-2015-
0411+0+DOC+PDF+V0//EN
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specific production process(es) used in one Member State may allow for lower OELs to be set
compared to use of alternative production process (for example) in another Member State.
Where Member States have, in the absence of EU OELs, set national OELs that vary from each
other this has the potential to create uncertainty on what is expected of employers in terms of
risk management. This may be perceived as inefficiency of the system, in particular by
employers that operate in more than one Member State.
EU-level OELs do not intend to completely eliminate the variation in national OELs but rather
ensure that all Member States introduce a minimum level of protection which is considered
appropriate in light of scientific knowledge and the state of technological development. Even if
Member States retain the possibility to adopt stricter levels, EU OELs significantly reduce the
scope of variation by introducing an upper limit for acceptable exposure levels.
As explained earlier, employers have the obligation to achieve exposure levels as low as
technically possible to be compliant with the minimisation principle under the CMD. What is
technically possible, however, may be different for the same chemical agent, depending for
example on the sector of the industry and the specific type of use of the chemical agents.
Substances such as RCS, for example, can occur in very diverse workplace situations and
therefore the possibilities to control exposures will differ. Without an EU-wide OEL, employers
who would like to be sure to comply with the legislation ("minimisation to as low a level as
technically possible") would need to embark on an extensive research into different practices
existing across EU Member States and in different types of industries to arrive at an
understanding of what might be the appropriate and feasible exposure limit review for their type
of business. In that sense an EU-wide OEL, based on a generally accepted methodology and
validated through tripartite discussions as a common denominator should be feasible for all uses
of the carcinogen, which simplifies compliance for business.
Similarly, for workers, in the absence of an OEL or where national OELs are too high, it would
be challenging to collect evidence that exposure levels in a specific factory are higher than what
should be possible. An OEL facilitates therefore discussions between employers and workers on
this matter by setting an agreed benchmark for compliance.
1.2
Who is affected by the problem and how?
As mentioned above, the total number of deaths attributed to occupational cancer in the EU is
reported to be 102,500 for 2011
35
.
Epidemiological studies indicate that occupational exposures cause 5.3–8.4 per cent of all
cancers
36
. However, the rates are not the same for all cancers, for some, such as sinonasal cancer
linked to wood dust exposure, work-related cancers are estimated in some countries to account
for almost half of all cancers in some countries of this type.
37
In 2012, cancers of the lung, colorectal, breast and stomach were the most common fatal forms
of cancer in Europe. The most common cancer sites were cancers of the female breast, followed
35
Eliminating occupational cancer in Europe and Globally,
Takala, J, European Trade Union Institute, October
2015.
Eliminating occupational cancer in Europe and Globally,
Takala, J, European Trade Union Institute, October
2015.
Imbernon E., « Estimation du nombre de cas de certains cancers attribuables à des facteurs professionnels en
France
»,
Institut
de
veille
sanitaire,
2003,
Available at http://www.invs.sante.fr/publications/2003/cancers_pro/rapport_cancer_pro.pdf.
17
36
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by colorectal, prostate and lung, which all together represent half of the overall burden of cancer
in Europe.
38
According to a UK study based on 2005 data, industries and occupations with high cancer
registrations include construction, metal working, personal and household services, mining, land
transport, printing/publishing, retail/hotels/restaurants, public administration/ defence, farming
and several manufacturing sectors. 56% of occupational cancer registrations in men are
attributable to work in the construction industry (mainly mesotheliomas, lung, stomach, bladder
and non-melanoma skin cancers).
39
The chemical agents subject to this IA have a direct impact on developing the above mentioned
types of cancer and are relevant to the sectors with high rates of cancer registrations.
40
For the workers and their families, cancer results not only in substantial quality of life losses,
but also in direct health care costs and indirect loss of present and future earnings (net of taxes)
both for the person affected and for the carers, in addition to the administration costs related to
the time and expenses incurred claiming for benefits, waiting for treatment etc.
Occupational cancer also impacts the economy at large, reducing labour supply (either
temporarily or permanently) not only by the person affected but also by his/her carers,
decreasing labour productivity, and increasing the burden on public finances through avoidable
public expenditure on health care, disability benefits, pensions for early retirement, and other
benefits.
As an illustration, according to a study published in November 2013, around 8,000-8,500 deaths
per year due to occupational cancer are estimated to occur in Italy alone, corresponding to
170,000 Potential Years of Life Lost and more than 16,000 Potential Years of Working Life
Lost, leading to around 360 mln  euros in indirect economic loss.
41
To these add the direct
health care costs of occupational cancer in Italy, estimated at around 456 mln euros. Another
study conducted in Spain estimated direct costs for diagnosis and treatment of occupational
bladder and lung cancer to be about 88 mln euros.
42
This did not cover indirect costs such as
costs of absences, production loss, loss of income and impairment.
43
For Member States, occupational cancer leads to increased healthcare costs related to treatment
and rehabilitation, as well as to higher expenditure on associated inactivity and early retirement
and compensation for recognised occupational diseases. It also increases administrative and
legal costs related to the handling of requests for benefits and dealing with recognized
cases. Foregone earnings and income as a result of ill health also lead to tax revenue losses for
social security systems.
For business, occupational cancer also implies costs in terms of productivity, as they lose skilled
workers and need to spend more in job search and training of new workers. Given the often long
time lag between exposure and illness and the probability of workers changing employers
during their work career, the risk of future productivity losses is unlikely to be internalised by
38
Cancer incidence and mortality patterns in Europe: Estimates for 40 countries in 2012,
Ferlay, J. et al.,
European Journal of Cancer,
49 (2013), pp. 1374–1403.
Occupation and cancer in Britain.
Rushton, L. et al., British Journal of Cancer. 2010 Apr 27;102(9):1428-37
According to animal toxicity studies 2 nitropropane may cause liver tumours in humans (although it should be
noted that there is no epidemiological evidence to substantiate this).
The burden of mortality with costs in productivity loss from occupational cancer in Italy,
Am J Ind Med. 2013
Nov;56(11):1272-9. doi: 10.1002/ajim.22224. Epub, June 24 2013.
García Gómez M, Urbanos Garrido R, Castañeda López R, López Menduiña P. Costes sanitarios directos de las
neoplasias de pulmón y vejiga de origen laboral en España en 2008. Rev Esp Salud Pública. 2012; 86: 127-38.
Available at http://scielo.isciii.es/scielo.php?pid=S1135-57272012000200002&script=sci_arttext&tlng=em
See Annex 4 for a discussion of terms used here.
18
39
40
41
42
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companies, and therefore not factored into present businesses decisions. Depending on the
relative strength of collective bargaining, some of the affected sectors/companies may also need
to pay higher wages to compensate for the higher occupational risk, which would affect their
competitiveness vis-à-vis otherwise similar companies which are confronted with less organised
labour. Finally, businesses located in Member States with where national OELs are relatively
stringent may be at a competitive disadvantage vis-à-vis enterprises in Member States with no or
higher OELs.
An indicative estimate of the direct and indirect health costs related to the agents covered in this
impact assessment can be found in the following section.
1.3
How would the problem evolve?
Estimations on the numbers of deaths and health costs between 2010 and 2069 have been made
in case no action is taken (baseline scenario) regarding the chemical agents subject to this
IA.
44,45
These are summarized in the Table 2 below.
Table 2. Estimated cancer deaths, cancer cases and related health costs in case no action is taken (baseline
scenario), 2010-2069
Chemical agent
Expected no. of
deaths
2010 – 2069
-
46
100
Not assessed
48
230
-
49
17,000
0
5,000
710
150
50
Expected no. of Cancer estimated health
cases
costs
2010 – 2069
-
47
160
Not assessed
250
0
24,000
0
12,000
2,500
490
60
2010 – 2069
€2.5 mln - 10.7 mln
€41 mln - 167 mln
n/a
€156 mln - 326 mln
n/a
€8.6 - 27 bln
None
€3 bln - 16 bln
€0.5 bln - 3 bln
€86 mln - 696 mln
€33 mln -83 mln
1,2 Epoxypropane
1,3 Butadiene
2 Nitropropane
Acrylamide
Bromoethylene
Chromium (VI)
compounds
Ethylene oxide
Hardwood dust
Hydrazine
o-Toluidine
Refractory ceramic
fibres (RCF)
44
IOM Research Project P937/99, May 2011 – Health, social-economic and environmental aspects of possible
amendments to the EU Directive on the protection of workers from the risks related to exposure to carcinogens
and mutagens at work
The reference period of 2010-2069 is established in the IOM study and used throughout the report. No
methodologically consistent information is available to modify this reference period to take into account
potential development between 2010 and 2015.
According to the IOM Research Project, less than one death per year was predicted from past or future exposure
- 100 attributable YLLs during 2010-2069 period.
Less than one per year.
According to the IOM Research Project, no baseline health impact was made because there was insufficient
epidemiological evidence to sustain such an assessment
According to the IOM Research Project, no deaths were predicted from past or future exposure
19
45
46
47
48
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Respirable crystalline
silica (RCS)
Vinyl chloride
monomer (VCM)
440,000
300
470,000
300
€192 bln - 493 bln
€194 mln - 472 mln
It is anticipated that there would be around 440,000 deaths from exposure to respirable
crystalline silica (RCS) and a similar number of new cancer cases. The related health costs
would range between 192 bln and 493 bln euro. The social partners, representing 18 European
industry sectors signed in 2006 a European Multi-Sectoral Social Dialogue Agreement on
Workers' Health Protection through the Good handling and Use of Crystalline Silica and its
products (NEPSi). The impact of NEPSi on the reduction of cancer cases and deaths in those
sectors
50
implementing the Agreement is under evaluation – results are not available to inform
this assessment. Exposure to hard wood dust, which potentially concern 3 mln workers in
Europe, is expected to cause 12,000 cases of cancers and 5000 deaths over the next 60 years,
with estimated health costs between 3 bln and 16 bln euro. On the other hand, relatively smaller
effects are expected from exposure to
o-Toluidine:
490 new cancer cases and 150 deaths before
2050.
These estimates, derived from the IOM study, are based on the assumption that for many of the
concerned chemical agents, past trends of declining exposures will continue. These trends were
related to technological progress, changes in work organisation and relative weight of different
industrial sectors but also to past legislative developments. It is difficult to predict whether such
trends would indeed continue in the absence of further EU action. The 60-year time frame of the
assessment poses also the challenge of anticipating future industrial developments whereby uses
of the chemical agents under consideration could either decline or grow and where potential new
uses could lead to new workplace risks.
Another important assumption in the study is that for some of the chemical agents the industry
has already achieved relatively low exposure levels, sometimes lower than the proposed OELs.
As this varies across the chemical agents, more information will be provided in Section 5 of the
report about the specific situation for each of the carcinogens as well as on the sources of the
information. Generally speaking, however, even where it is estimated that current exposure
levels are already very low, lack of EU OELs or too high EU OELs mean that it will still not be
clear for employers and workers and enforcing authorities whether the achieved exposure level
is satisfactory from the point of view of compliance with the minimisation principle of the
CMD.
Table 1 in Annex 6 presents the current limit values in the EU Member States. The information
regarding existing national OELs
51
was gathered through an extensive 2014 survey.
52
Lack of
EU action will most likely mean that there will remain Member States where no limit values
exist for certain carcinogens or where those values are too high to ensure adequate worker
protection. A minimum standard across the EU will not be ensured, to the detriment of both
worker protection and the internal market.
50
Aggregates, cement, ceramics, foundry, glass fibre, special glass, container glass, flat glass, industrial minerals,
mineral wool, natural stones, mining, mortar, pre-cast concrete sectors and clay sector.
There is no obligation for Member States to inform the Commission about their intentions update their national
lists of OELs, apart from initiatives which would be related to OELs established at EU level.
Further information on this survey is provided in Annex 2 of this document
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51
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2
2.1
W
HY SHOULD THE
EU
ACT
?
Does the EU have the right to act?
The Treaty on the Functioning of the EU (TFEU) in Article 153 empowers the EU to support
and complement the activities of the Member States as regards the protection of workers' health
and safety, and to adopt by means of Directives, minimum requirements for gradual
implementation. On this basis the CMD provides a specific basis for action. For more details
regarding the full legislative framework see Annex 7.
2.2
Why is EU action needed and what is its added value?
Limit values under the CMD, which according to the Directive are regarded as an important
component of the general arrangements for the protection of workers
53
, should be established for
all those carcinogens and mutagens for which the available information, including scientific and
technical data, make this possible
54
, and must also be revised whenever this becomes necessary
in the light of more recent scientific data.
One of the most important advantages of setting OELs is that they provide robust and objective
benchmarks to help demonstrate compliance with the current legal framework. They establish
ceiling exposure values above which exposure should not occur (in a weighted average over one
working day). This enables the employer, based on the risk minimisation approach, to
implement the OSH risk management measures that reflect the needs of their sector. In some
cases it may be possible to achieve exposure reductions well below the level at which the OEL
is set, for other sectors this may be less achievable. However, in all cases the resultant exposure
should not exceed the OEL and over time, with developments in technology, there should be a
trend for overall exposures to reduce to a minimum.
The concept and use of OELs is well understood by all the main stakeholder groups. As such
they are a common reference point that can be used as a practical tool by employers, workers
and enforcers to assess compliance with the general CMD requirements. They can also be used
by process plant and machinery designers when planning new, or considering alterations, to
existing process plant.
OELs therefore make an effective contribution to the practical implementation of the
requirements in the legislation for prevention and reduction of exposure to chemical
carcinogens.
The continued support from stakeholders for OELs was restated during a meeting on 18th
November 2015 of members of the tri-partite Working Party on Chemicals to discuss those
aspects of the overall evaluation of the EU OSH acquis that are relevant to chemicals risk
management. During this meeting the Members States', employers' and workers' representatives
agreed that 'OELs are an important tool for chemical risk management at the workplace and
there is a need to adopt values for more substances based on duly justified reasoning. For
example an early focus should be on carcinogenic, mutagenic and reprotoxic substances'.
In addition, during 2015, Commission services asked the Senior Labour Inspectors Committee,
via its working group on chemicals (CHEMEX), to assess the utility of OELs from an enforcer's
perspective, including the question 'Are OELs considered (by labour inspectors) to be
critical/not important when carrying out inspections'?
55
All respondents considered OELs to be
essential and particularly valuable when carrying out inspections and enforcement.
53
54
55
recital 13 of Directive 2004/37/EC
recital 12 of Directive 2004/37/EC
Summary of the responses to SLIC CHEMEX KSS Questions Set - Implementation of occupational exposure
limits at national level – draft response document
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It can be concluded that OELs provide an added value as a common, and well understood,
objective measure to better facilitate the practical implementation of the general requirements
for prevention and exposure reduction. There is a clear support for their continued use from key
stakeholders.
For some sectors it may be that a given OEL is the best that can be achieved but in others
sectors, or for specific uses, it is possible that much better exposure values can and should be
achieved – this is taken into account in the minimum standard nature of OSH in general and
OEL setting in particular.
Data presented in this report indicate wide differences in the Member States regarding the
setting of OELs for the identified carcinogenic chemical agents
56
. Some Member States have
already established legally enforceable OELs which are at the same value or lower than the
value recommended by the Advisory Committee on Safety and Health at Work (ACSH). This
demonstrates that unilateral national action is possible as regards setting an OEL for these
chemical agents. However, as shown in Table 2 in Annex 6 there are also many cases where
Member States have no OELs or ones which are less protective of worker health than the value
recommended by ACSH.
Under such circumstances a minimum basis of protection against the risks arising from workers'
exposure to these carcinogens cannot be ensured for all EU workers in all Member States by an
action taken by Member States alone. Table 4 in Annex 6 provides an overview of the
proportion of potentially exposed workers who lack such legal protection and this factor is taken
into account in the analysis of impacts of introducing an OEL for each of the considered
carcinogens. It follows that an action taken at the European Union level to achieve this objective
appears to be necessary and in line with Article 5(3) of the Treaty on European Union.
Absent or too high OELs also provide a potential incentive for companies to locate their
production facilities in Member States with the lower standards. This distortion of the internal
market may be reduced by establishing clear minimum standard OELs at EU level.
Amending the CMD can only be done by action at EU level and after a two-stage consultation
of the social partners (management and labour) in accordance with Article 154 TFEU.
2.3
What are the EU instruments relevant to dealing with carcinogens at the workplace?
From the mid-1960s the European Union developed a legal framework addressing control of
chemical risks under both social policy and internal market areas of EU policy. This framework
places duties on authorities, businesses, and individuals to manage risks associated with the sale
and use of chemicals. By the late 1990s a comprehensive and sophisticated system of
interdependent Directives and Regulations had been established to protect humans and the
environment from hazardous chemicals.
To protect workers from chemical carcinogens both employers and authorities must apply the
same three stages necessary for all risk control: i) identify what harm might be caused ('hazard
identification'); ii) identify the likelihood and severity of the harm actually being caused ('risk
assessment'); and iii) where necessary put in place measures to mitigate harm ('risk
management').
Directives setting out an agreed system for chemical hazard identification (i) were developed –
augmented where necessary by additional provisions in topic specific Directives. The outcomes
of this hazard identification are then applied in Directives and Regulations focussed on the key
areas of chemical risk – in the case of worker protection from chemical carcinogens these were
laid down in the CMD.
56
See Table 1 in Annex 6.
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A subsequent process of chemicals risk assessment (ii) by European authorities built on this to
identify measures needed to protect the environment or humans as consumers, members of the
public, or workers. This risk assessment resulted in recommendations for regulatory risk
management (iii) from a suite of available options.
The key EU risk management outcomes for the protection of workers from chemical
carcinogens were CMD OELs (under social policy) and/or 'restrictions' on the placing on the
market and/or use of certain chemicals (principally under internal market policy).
The REACH Regulation
57
, which was adopted in 2006, consolidated and evolved several parts
of the EU chemical risk control system – principally those relating to risk assessment and
internal market risk management measures. REACH further augmented these changes by
establishing a new 'authorisation' risk management option.
Both CMD and
the REACH Regulation therefore
protect workers from risks associated with
exposure to carcinogens. The two legal acts are complementary. CMD is a more targeted
measure intended for protection of those employed by others from occupational carcinogens,
while REACH applies more broadly to protect the health of humans and also the environment
and also offers mechanisms which can be used to target risk controls to protect workers.
A chemical carcinogen may appear on both CMD Annex III and REACH Annex XIV without
systematic conflict
58
. The OSH ʻFramework Directiveʼ – under which CMD is made – applies
without prejudice to existing or future national and EU provisions which are more favourable to
protection of the safety and health of workers at workʼ. REACH in turn applies without
prejudice to worker protection legislation, including the CMD.
REACH is designed to integrate with the rest of the EU legal framework with which it co-exists
– including CMD. As a key example of this, REACH does not include a mechanism to set EU
OELs for carcinogens – these are properly established under social policy Directives where the
social partners and co-legislators play a more prominent role.
REACH generates information on chemical agents which are 'placed on the market' (above one
tonne per year) and used in the EU. It also includes the 'authorisation' and 'restriction'
mechanisms – both of which may, in some cases, be available as risk management options for
occupational carcinogens.
Carcinogens are one of several types of hazardous substance which can be added to Annex XIV
to REACH, meaning they become subject to 'authorisation'. Once a given 'sunset' date is passed,
these substances may only be placed on the EU market and/or used when an authorisation has
been applied for and granted by the European Commission, taking into account the advice of the
European Chemicals Agency, that either the risks associated with use are adequately controlled
or that, if this is not possible, ongoing use of the substance is socioeconomically justified and
there are no suitable alternatives.
The Commission may make exemptions from REACH authorisation under certain conditions,
including where specific Union legislation already exists which imposes minimum requirements
relating to the protection of human health for the use of a substance. So far no exemption has
been made for substances used at the workplace.
57
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning
the Registration, Evaluation, Authorisation and Restriction of Chemicals
Of the 13 chemical agents considered here for listing in CMD Annexes I (PGSs) or III (OELs) three have been
added (in some form) to the Candidate List as 'substance of very high concern' (SVHCs) : Hydrazine,
o-
Toluidine, and RCFs. RCFs have, further, been recommended by ECHA for inclusion in Annex XIV. Certain
chromium (VI) compounds have been identified as SVHCs on the Candidate List and also, subsequent to ECHA
recommendation, have been added to REACH Annex XIV.
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Restrictions set conditions under which placing on the market and/or use of a chemical
substance (or mixture or article containing it) may be permitted. These range from a near-total
ban through to substance concentration specifications or established risk management measures
to be observed by 'downstream users'.
Restrictions are a flexible, targeted chemicals risk management option carried forward from the
pre-REACH EU chemicals framework. Restrictions and OELs have long co-existed as different
possible outcomes from the EU chemicals risk assessment process – indeed four of the five
existing binding OEL values established at EU level under the OSH Directives (asbestos,
benzene, lead, and vinyl chloride) are already partnered with REACH restrictions.
As a result of their flexibility it is, conceptually, possible to establish an 'OEL-like' exposure
limit via a REACH restriction – in 2013 the Netherlands REACH authorities proposed such a
measure. In response, in November 2013, the lead Commission services for the REACH
Regulation wrote to the European Chemicals Agency (ECHA), with the common Commission
services' view that 'any proposal for adoption of an exposure limit value at the occupational
premises should not be implemented under REACH and should only be set under the
appropriate workers' protection legislation, which is specifically designed to establish and
implement OELs'. In the same month the ACSH adopted an Opinion formally expressing the
views of the Member States, employers, and workers' representatives that the OSH acquis is the
more appropriate way to establish exposure limits for worker protection to chemicals.
59
Clear synergies between REACH and worker protection legislation can be seen – including in
particular that REACH 'registration' should result in more information being available to inform
chemicals risks assessment. REACH 'authorisation' also both establishes, for a given chemical
agent, a clear and renewed pressure to substitute for safer alternatives, and can drive applicants
to improve their worker protection risk assessments and controls. At the same time, adoption of
EU OELs can be useful inputs for REACH risk characterisation.
The REACH status (authorisation and/or restriction) of the 13 chemical agents under
consideration in this report is as follows:
Out of scope of REACH: hardwood dust, process-generated RCS.
On the Candidate List of 'substances of very high concern' potentially to be made subject
to authorisation: acrylamide, hydrazine, RCF,
o-toluidine.
Currently subject to authorisation: some chromium VI compounds.
Currently subject to restriction: acrylamide, restricted above a certain concentration for
the placing on the market or use in grouting (REACH Annex XVII Entry 60); chromium
(VI) compounds, restricted above a certain concentration for the placing on the market or
use in cement, with certain exemption (REACH Annex XVII Entry 47); vinyl chloride,
restricted (REACH Annex XVII Entry 2) for use as an aerosol propellant. All of the
chemical agents in question, where placed on the market, are restricted for supply to the
general public (REACH Annex XVII Entries 28 and 29).
A more detailed list of REACH status of the concerned chemical agents can be found in Annex
7 (14.2.1).
2.4
How does this initiative relate to the envisaged review of the OSH acquis?
The CMD is part of an overall OSH acquis, comprising the Framework Directive 89/391/EEC
and 23 individual directives. The Commission is currently finalising an ex-post evaluation of the
59
The Advisory Committee on Safety and Health at Work, Opinion: Protection of workers' health from risks
arising from exposure to chemicals at the workplace: EU Occupational Exposure Limit Values under OSH and
limit values under other EU legislation, Doc. 01903/13, adopted on 28 November 2013
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acquis, covering the period 2007-2012 and 27 Member States. This evaluation consists of a wide
assessment of the legislation, including in terms of benefits, research and new scientific
knowledge. It also falls under the remit of the Commission's Regulatory Fitness and
Performance Programme (REFIT), which aims to ensure that the EU regulatory framework is
relevant, coherent, effective, efficient, provides EU added value and targets ensuring the
avoidance of any unnecessary regulatory burden.
The results of the ex-post evaluation may lead to the further assessment of specific issues and
potentially impact assessments covering possible initiatives to improve the operation of the
regulatory framework. The Commission will be working throughout 2016 on the follow-up of
the evaluation as regards collection of any necessary further evidence and justifications for the
modernisation of OSH framework with the aim of increasing effectiveness and efficiency,
reducing regulatory burden whenever possible without undermining the public interest
objectives of the legislation.
Within the framework of the overall ex-post evaluation the CMD was, along with the other
individual OSH Directives, subject to a specific assessment through an external evaluation
study. The conclusions of this study refer mainly to broader issues such as the interface between
the CMD and REACH, or the possibility to merge the CMD with the Chemical Agents Directive
(CAD)
60
. The former is discussed at section 2.3 in this report. As for the latter, no clear
conclusions can be drawn as views of stakeholders at national and EU level are quite polarised.
There is however consensus on maintaining the material provisions of the two acts.
Secondly, concerning specifically OELs, experts discussions conducted in the framework of the
evaluation confirmed that these are an important tool for chemical risk management at the
workplace. It was indicated that the terminology used to describe different types of OELs (and
corresponding procedures) should be aligned and guidance on the practical use of OELs should
be developed.
The fact that the evaluation did not question the existence of OELs and pointed to the need to
revise them and adopt new ones, together with the further evidence and analysis gathered in the
framework of the impact assessment, support the conclusion that the two technical annexes of
the Directive should be updated.
3
3.1
W
HAT SHOULD BE ACHIEVED
?
What are the general policy objectives? What are the more specific objectives?
The main general policy objective of this initiative is to ensure and maintain a high level of
protection of worker's health and safety in the European Union.
The specific objectives are:
To ensure up-to-date protection from occupational exposure to chemical carcinogens in
the European Union;
To increase the effectiveness of the EU framework by updating it on the basis of
scientific expertise;
To ensure more clarity and create a better level playing field for economic operators.
60
Evaluation of the Practical Implementation of the EU Occupational Safety and Health (OSH) Directives in EU
Member States – Report by directive: Directive 98/24/EEC on the protection of workers from the risks related to
chemical agents at work,
section 7.4 'Coherence; Merging the CAD and CMD', COWI, November 2015, p. 128-
129.
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3.2
Are these objectives consistent with other EU policies and with the Charter for
fundamental rights?
The objectives of the initiative are consistent with the fundamental rights as set out in the EU
Charter of Fundamental Rights, in particular article 2 (Right to life) and article 31 (Right to fair
and just working conditions which respect his/her health, safety and dignity).
Ensuring a safe and healthy work environment for over 217 mln workers in the EU is a strategic
goal for the European Commission according to the recent Communication from the
Commission on the EU Strategic Framework on Health and Safety at Work 2014 – 2020.
61
One
of the main challenges identified in the EU OSH Strategy is to improve the prevention of work-
related diseases by tackling existing, new and emerging risks.
Improving working conditions and preventing workers from suffering serious accidents and/or
occupational diseases and promoting workers’ health throughout their working life, is a key
principle in line with the ambition for a Triple A Social Europe rating set by the Juncker
Commission. It also has a positive impact on productivity and competitiveness and is essential
to promote longer working lives in line with the Europe 2020 strategy’s objectives for smart,
sustainable and inclusive growth.
62
The objectives of this initiative are also in line with and complementary to the ILO Convention
no. 170, concerning safety in the use of chemicals at work. The Convention, adopted so far by
six EU Member States
63
, establishes minimum universal standards on OSH to be observed
worldwide. CMD and CAD reflect these standards and go further, establishing more stringent
and protective conditions that EU Member States are in a position to implement. They also
provide a stronger motive for MS to enact national measures as they are legally bound to do so.
ILO 170 is intended to complement and explicitly envisages,
inter alia,
(Article 13), that
'Employers shall: (a) ensure that workers are not exposed to chemicals to an extent which
exceeds exposure limits or other exposure criteria for the evaluation and control of the working
environment established by the competent authority, or by a body approved or recognised by the
competent authority, in accordance with national or international standards (…)'.
4
W
HAT ARE THE VARIOUS OPTIONS TO ACHIEVE THE OBJECTIVES
?
4.1
Complementary measures
the minimisation obligation under Article 5 of the CMD Directive;
methodologies for the development of OELs for carcinogens;
measurement methodologies regarding exposure to hardwood dust, taking account of
mixed exposure to both hard- and softwood dust;
how to take into account in the cost-benefit analysis the EU Charter of Fundamental
Rights, in particular Article 1 (Human dignity), Article 2 (Right to life) and Article 3
(Right to integrity of the person).
During discussions in the ACSH
64
the need for further guidance was called for, in particular on:
In the same vein, one of the conclusions of the Social Partners consultation was that there was a
need for effective implementation of training and information requirements, which are a key
aspect of the prevention policy. Workers called the Commission to set up a strategy to improve
coordination and sharing of information at EU level. Employers indicated that there was an
61
62
63
64
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52014DC0332&from=EN
COM(2010) 2020 and COM(2014) 130 final
Finland, Germany, Italy, Luxembourg, Poland, and Sweden
Opinion of the ACSH of 05/12/12
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added value in the preparation of guidance documents with recommendations on workers
protection against carcinogens and mutagens exposure.
Most of these actions are ongoing or will be undertaken as complementary measures to this
initiative. These are not alternative options to updating the CMD but are rather part of the
baseline and will further reinforce potential positive effects of the considered options. Non-
binding guidance cannot address the issues identified in the problem definition; only clear
listing of chemical agents under the CMD and setting OELs will introduce the legal certainty
needed for employers, workers and enforcers with regard to managing the exposure to
carcinogenic chemical agents in the workplace.
4.2
Discarded options
Several other options which could be considered as alternative mechanisms to control and limit
exposures to carcinogens in the workplace have been discarded as they were considered
disproportionate or less effective in reaching the objectives of this initiative.
A. Banning the use of the carcinogenic chemical agents
As explained above, for most carcinogens even a very low OEL does not completely eliminate
the risk of triggering a cancer. In that sense the risk could only be reduced to zero by eliminating
the presence/use of the substance in the workplace.
Indeed, substitution is the first option in the hierarchy of risk management measures under the
CMD that an employer needs to consider. This means that if it were technically feasible,
employers should have already replaced use of the concerned chemical agents with safer
alternatives.
Wherever substitution is a suitable alternative for use of the 13 chemical agents in question then
the CMD already requires this, regardless of the existence or otherwise of an OEL. As this legal
standard already establishes that these carcinogens should not be used in the workplace where
alternatives are available, establishing a more strict prohibition in the form of a ban would
constitute a disproportionate measure with a strong negative impact on businesses. Moreover, in
the case of process-generated substances such as hardwood dust or RCS, banning is not only a
counterintuitive option but it would also result in operational challenges which could result in
closure of otherwise viable and compliant businesses – potentially across whole industry
sectors.
B. Self-regulation (industry voluntary agreements)
The NEPSi Agreement, including the practical guidelines to risk management, contributes to the
overall protection of workers health in the affected employment sectors.
NEPSi was established in part as a self-regulatory alternative to measures reflected in the
current proposal. Stakeholders implementing NEPSi have therefore indicated concern that the
current proposal may pose a challenge to industry participation in self-regulation initiatives in
the future. However, in addition to any recommendations of the NEPSi evaluation report, which
shall be issued by the European Commission in Q2 2016, it should be noted that the
effectiveness of this self-regulation initiative is hindered by the following:
it does not apply to all sectors where exposure to RCS occurs, in particular not to the
construction sector, which, has the largest burden of occupational cancer
65
;
it is not binding and cannot therefore be enforced by national authorities.
65
Rushton, L. et al. Occupation and cancer in Britain. Br J Cancer. 2010 Apr 27;102(9):1428-37
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Consequently, the NEPSi agreement and any similar future initiatives would be an important
complementary measure but could not be as effective as OELs in setting and enforcing the same
level of minimum protection across the EU and in all sectors of industry.
C. Sector or industry specific OELs
It could be envisaged that, where justified, sector, industry or use specific OELs could be set or
derogations could be allowed for specific sectors, industries or uses for a defined time-period or
subject to specific conditions.
As a result of such an approach we would have different minimum standards of worker
protection across the EU for the same type of work and the same chemical agent, which is not
permissible in the context of binding OELs as established under the CMD.
Further the process by which the tripartite ACSH agree their Opinion on appropriate EU OELs
under CMD includes extensive consideration of socioeconomic and technical feasibility factors
– including sector, industry and use-specific concerns. As a result these concerns are already
reflected in the value supported by the ACSH and taken forward in the current proposal.
This option, therefore, had to be discarded as the current legal framework does not provide a
legal basis for such provisions.
Where an EU OEL is established, Member States and employers retain the right to implement
more protective values than the proposed minimum standards, also taking into account the
general CMD duty to substitute, eliminate or otherwise minimise exposures.
D. Providing industry-specific scientific information without setting OELs
Another option could be for the Commission to collect and provide industry-specific scientific
information to support employers in complying with the CMD obligations.
Apart from the practical difficulties related to collection of relevant data for the multitude of
sectors concerned, it is considered that this option would not be effective in achieving the
objectives of the initiative for the following reasons:
the way the information is used by employers would not be enforceable by surveillance
authorities;
such an option would not fit with the overarching legal framework of the CMD, which
provides for general exposure management requirements to be specifically supplemented
by EU-wide minimum standard OELs:
in some cases, extensive industry- and chemical agent- specific information and
guidance already exists and should be taken into account by employers during risk
assessments – but this has not demonstrably addressed harmful exposures at EU level as
identified in the IOM study.
E. Market-based instruments
Market-based instruments such as subsidies, tax breaks or reductions of social insurance
contributions, are sometimes used by Member States to incentivise business to comply with
health and safety rules. Such instruments can effectively support compliance with exposure
limits. However, to be applied effectively in this context, such mechanisms would need to be
linked (directly or indirectly) with the actual levels of exposure at firm level. These are
generally not observed (as it also emerges from the analysis presented in Section 5 below), and
improved data collection would likely result in being extremely costly and cumbersome. It
should also be noted that these instruments remain in the hands of Member States and the extent
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to which they are used vary significantly
66
. This option alone would therefore not be effective in
ensuring the same level of minimum protection across the EU.
F. Regulation under other EU instruments (REACH)
As detailed in section 2.3, other EU regulatory options exist for managing risks to workers
associated with exposure to some chemical carcinogens – most notably REACH 'authorisation'
or 'restrictions'.
As previously indicated, REACH is a relevant regulatory instrument for protection of workers
from hazardous chemicals, including in particular chemical carcinogens. However, in the case
of the present proposal CMD is the more appropriate regulatory instrument for the following
reasons:
Hardwood dust and respirable crystalline silica, which are process generated in the
workplace, are outside scope of REACH.
CMD covers worker exposure to carcinogenic agents released by
any work activity,
whether produced intentionally or not, and whether available on the market or not.
REACH sets directly-acting harmonised standards from which Member States cannot
deviate except in exceptional (and possibly time limited) circumstances. CMD sets
'minimum standards' which allow Member States to maintain or implement more
protective measures – which is appropriate in the interest of worker protection. OELs are
an example of this.
REACH places the onus of risk assessment on the supply chain, and is 'chemical agent
specific'. CMD risk assessment is more likely to be workplace- and process-specific and
should take into account aggregated exposure of workers to all occupational carcinogens.
From the point of view of preventing exposure to carcinogens CMD offers therefore a
more holistic approach to workplace risks.
REACH authorisation is a risk management measure covering all risks arising from
given intrinsic properties of a substance, including the risks for workers. In the absence
of explicit derogations it applies to all placing on the market for a use and use of subject
chemical substances and so is a less targeted measure than a CMD OEL, which applies
in the long-established OSH regulatory context and relates specifically to the workplace.
REACH authorisation can complement CMD, in particular by strengthening the
substitution principle and its full implementation, as well as driving toward additional
risk management.
It should also be noted that, as it is based on social policy provisions of the TFEU
67
,
CMD reflects the role foreseen there for the social partners in establishing standards for
worker protection.
OELs are an important part of CMD and of the wider occupational safety and health
approach to managing chemical risks. REACH, on the other hand, is not intended to set
OELs. The concerned Commission services, Member States, and the social partners have
all expressed their view that OSH Directives are the appropriate EU legislative
framework to establish limit values for the protection of workers.
A comparison table summarising key characteristics of the CMD and REACH approaches to
risk assessment and control of occupational carcinogens can be found in Annex 7 (14.2.3).
66
European Agency for Safety and Health at Work. “Economic Impact of Occupational Safety and Health in the
Member States of the European Union.” Available at https://osha.europa.eu/en/publications/reports/302
Consolidated version of the Treaty on the Functioning of the European Union.
OJ C 326, 26.10.2012.
29
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From the point of view of enterprises, it is important to note that compliance costs associated
with workplace legislation (such as protective measures and equipment) directly contribute to
better risk management, and that administrative costs triggered by workplace legislation are
relatively small.
In 2015 an ongoing collaboration of 40 European sectoral and cross-sectoral associations, nine
national associations, and several corporations, all with interests in manufacturing, importing,
and using chemical substances began actively engagement with the Commission services in
order to ensure more efficient risk management measures that can combine OSH OELs in
addition to REACH risk management options as the more proportionate measure where
chemical risks identified during risk assessment relate principally to worker protection.
68
The
Commission services concerned are working with this 'Cross Industry Initiative'
69
and to discuss
the relevance of their proposals in the operation of EU chemicals policies regarding worker
protection.
Targeted CMD OELs are appropriate for protecting workers from occupational exposure to the
chemical carcinogens subject to the present proposal. The synergies in the relationship between
CMD and REACH provide further opportunities for regulatory measures as appropriate.
It should be noted that this impact assessment does not aim to assess whether REACH risk
management measures are proportionate and effective. The present proposal does not preclude
relevant REACH measures from being proposed where this is justified, and in some cases a
combination of CMD OELs and other regulatory (or non-regulatory) risk management
measures, including under REACH, may be justified.
4.3
Options retained for consideration
Identification process
Reviewing or setting new OELs under CMD follows a specific procedure involving seeking
scientific advice and consulting the ACSH. Article 16 of the CMD, which states that
scientific/technical data should be included in the basis on which OELs are set, does not
determine which scientific body should be the source of such data. In practice, the Commission
and the ACSH principally seek the advice of SCOEL, but can also refer to scientific information
sourced elsewhere as long as the data is adequately robust and is in the public domain (e.g.
IARC monographs or conclusions of national OEL-setting science committees).
70
68
Recommendations by an EU-wide cross-industry initiative for better regulation in chemicals management,
position paper, November 2015.
Position
paper
available
at:
http://ec.europa.eu/smart-regulation/refit/refit-
platform/docs/submissions/cii_enhancing_the_effectiveness_of_osh_310715_en.pdf
See “Figure 3. Simple representation of EU OEL setting procedure” (annex 9).
30
69
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Figure 3. Simple representation of EU OEL setting procedure
The SCOEL is an independent scientific committee, established by a Commission Decision and
composed of 21 experts appointed in their personal capacity as leading experts in fields relevant
for protection of workers from risks associated with workplace exposure to hazardous
chemicals.
71
SCOEL carry out scientific evaluation at EU level and as a result publish a single evaluation
document (previously a "SCOEL SUM", more recently a Recommendation or Opinion) for
hazardous chemicals where there is priority concern for worker protection. SCOEL procedures
for the adoption of a Recommendation by SCOEL include an external consultation with
identified contact points in all of the Member States; this ensures scrutiny of the scientific
evidence and methodological approach used by SCOEL and ensures transparency of the process.
The Advisory Committee on safety and health at work (ACSH) is a tripartite body set up in
2003 by a Council Decision (2003/C 218/01) to streamline the consultation process in the field
of occupational safety and health and rationalise the bodies created in this area by previous
Council Decisions. The Committee's remit is to assist the European Commission in the
preparation, implementation and evaluation of activities in the fields of safety and health at
work. The Committee is composed of three full members per Member State, representing
national governments, trade unions and employers' organisations, also organised in three
separate interest groups within the Committee. The ACSH is supported by working parties of
experts on given topics of interest – also tripartite but with smaller selected expert membership.
The Working Party on Chemicals (WPC) serves the ACSH according to a mandate agreed by
the plenary Committee, and in particular undertakes detailed technical and policy negotiation of
EU limit values as well as broader chemicals policy support for the ACSH and Commission.
The ACSH discusses adopted SCOEL Recommendations (and/or other appropriate scientific
evidence) and adopts a formal Opinion on what, in practice, is considered to be achievable by
employers whilst ensuring that workers' health is adequately protected.
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As established by Commission Decision 2014/113/EU on setting up a Scientific Committee on Occupational
Exposure Limits for Chemical Agents and repealing Decision 95/320/EC, OJ L 62, 4.3.2014, p. 18
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In the case of the carcinogens considered in this report, SCOEL concluded recommendations on
all but two.
72, 73
Table 1 in Annex 5 sets out the status of relevant adopted SCOEL
recommendations.
While the aim of ensuring the protection of the health of workers is maintained, binding OELs
set under CMD are usually based on factors beyond the independent scientific advice, because
they must also reflect other factors such as 'feasibility' and taking into account the views of the
social partners.
Amending the CMD can therefore only be proposed after a two-stage consultation of the social
partners (management and labour) in accordance with Article 154 TFEU. This consultation took
place in 2004 and 2007 and addressed the following elements: the possibility of extending the
scope of the Directive to include reprotoxic substances, the revision of existing OELs and the
establishment of new ones for more substances, need to develop a EU-wide methodology for
carcinogens and mutagens OELs setting, and the need to improve the training and information
requirements for workers.
Between 2009 and 2011 an external contractor evaluated, on behalf of the Commission, health,
socio-economic and environmental aspects of the proposed amendments to CMD in order to
inform impact assessment according to the regulatory procedures in place at that time. Between
2010 and 2013 the Working Party on Chemicals of the ACSH undertook detailed discussion on
these issues in an increased work schedule, aiming to secure stakeholder engagement and
agreement on values to propose for ACSH adoption.
The consultation process resulted, amongst others, in the support of the following:
to bring a limited number of so-called process generated substances (PGSs) under the
scope of the Directive by including them in Annex I,
to revise existing OELs in Annex III in the light of most recent scientific data, and
to add additional OELs for a limited number of substances in Annex III where available
information, including scientific and technical data supports this.
The ACSH, in an Opinion adopted in December 2012, and in supplementary Opinions adopted
in May 2013 and November 2013, confirmed (with a few dissenting opinions) the OELs initially
developed by the SCOEL (where relevant) and approved inclusion of these into CMD.
The three adopted ACSH Opinions include, where necessary, specific comments from the
interest groups (the social partners and Member States) which broadly reflect the principal
points maintained by each interest group throughout discussions of the Working Party on
Chemicals (WPC). In many cases there are no specific comments as there was a consensus view
of the three interest groups. As such, the final ACSH Opinions should be taken as representative
of the views of stakeholder groups represented.
In addition, the amendment of the CMD is routinely discussed at meetings of the tri-partite
WPC. Following adoption of the three ACSH Opinions this discussion has primarily focussed
on the state of play and timing of the next steps of the planned amendment of the Directive.
They have not expressed additional views on the content of the adopted opinions.
In principle, revision of the Annexes should be conducted on regular basis, as soon as new
scientific data is available and the technical feasibility of introducing new or revised OELs has
been established. The duration of the current preparatory work reflects that it is a first
72
73
The two exceptions are 2 nitropropane and
o-toluidine.
In December 2015, reflecting scientific developments and updated working procedures, SCOEL was mandated
to further consider five of these 13 agents: respirable crystalline silica, chrome (VI) compounds, hydrazine, o-
toluidine, 2 nitropropane. Ongoing SCOEL work may, in due course, influence the present or future proposals
for limit values for the chemical agents concerned.
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preparation of a proposal for a relatively large number of new/revised limit values. Appropriate
modes of cooperation between all the concerned actors as well as working methods within the
advisory bodies had to be developed.
It is expected that the procedures and working methods described above and established in the
course of the current exercise will give a good basis to complete preparatory steps leading to
eventual future revisions of the CMD in a much shorter time. The fact that a second proposal for
the introduction of OELs for additional chemical agents may be presented in the near future
should be seen precisely as a step of a continuous, regular process of updating of the CMD,
where necessary.
Identified options
The Table 3 below summarises options for different OELs for each of the 13 chemical agents.
A baseline scenario of no further EU action is Option 1 for each chemical agent represented in
this initiative.
As explained above, for each of the chemical agents scientific and technical data has been
considered and discussions at the ACSH have taken place, resulting in values to be proposed
into co-decision as an OEL. Directly adopting the values agreed by the ACSH forms Option 2
for each chemical agent.
Where appropriate and depending on specific characteristics of the agents, flanking options to
either propose a OEL which, compared with the ACSH value, is lower (theoretically more
protective of worker health) or higher (theoretically less protective of worker health) are also
presented as Option 3 and/or 4 respectively for each chemical agent.
These flanking values are drawn from the IOM Study, for which they were established by
preference: i) from a SCOEL Recommendation if available; ii) as values reflecting available
data (for example taking account of existing national OELs); or iii) on the basis of
recommendations from the contractor (for example taking into account non-EU OELs). Where
available data do not support setting a lower or higher OEL than the ACSH value, these options
are discounted. Further detailed information regarding the source of these additional options
may be found in the relevant IOM Study reports for each of the chemical agents in question.
In the case of RCS, options 2, 3 and 4 include the possibility of inclusion in the Annex I of
CMD along with OEL proposals under Annex III.
In addition, for each chemical agent where SCOEL has identified significant risk of adverse
systemic affects resulting from dermal uptake a 'skin notation' ('sk.') is indicated alongside the
numerical OEL.
Table 3. Options matrix
Name and CAS
no. of the
chemical agent
where relevant
Option 1
(baseline
- existing
OEL)
Option 2
(ACSH opinion)
(ppm – parts per
mln, mg/m
3
or
f/ml - fibres per
ml)
1 ppm
(2.4 mg/m
3
)
1 ppm
(2.2 mg/m
3
)
5 ppm
(18 mg/m
3
)
33
Option 3
(more stringent)
(ppm – parts per
mln, mg/m
3
or f/ml -
fibres per ml)
n/a
Option 4
(less stringent)
(ppm – parts per
mln, mg/m
3
or f/ml -
fibres per ml)
5 ppm
(12 mg/m
3
)
5 ppm
(11 mg/m
3
)
n/a
1,2 Epoxypropane
(propylene oxide)
75-56-9
1,3 Butadiene
106-99-0
2-Nitropropane
79-46-9
none
none
none
0.5 ppm
(1.1 mg/m
3
)
n/a
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Name and CAS
no. of the
chemical agent
where relevant
Option 1
(baseline
- existing
OEL)
Option 2
(ACSH opinion)
(ppm – parts per
mln, mg/m
3
or
f/ml - fibres per
ml)
0.1 mg/m
3
Sk.
3 mg/m
3
0.025 mg/m
3
1 ppm
(1.8 mg/m
3
)
Sk.
0.1 ppm
(0.5 mg/m
3
)
0.3 f/ml
Option 3
(more stringent)
(ppm – parts per
mln, mg/m
3
or f/ml -
fibres per ml)
0.03 mg/m
3
Sk.
1 mg/m
3
n/a
n/a
Option 4
(less stringent)
(ppm – parts per
mln, mg/m
3
or f/ml -
fibres per ml)
n/a
n/a
0.05 mg/m
3
n/a
Acrylamide
79-06-1
Hardwood dust
Chromium (VI)
compounds
Ethylene oxide
75-21-8
o-Toluidine
95-53-4
Refractory
Ceramic Fibres
(RCF)
Respirable
crystalline silica
(RCS)
Vinyl chloride
monomer
75-01-4
Bromoethylene
(Vinyl bromide)
593-60-2
Hydrazine
302-01-2
none
5 mg/m
3
none
none
none
none
n/a
0.1 f/ml
1 ppm
(5 mg/m
3
)
1 f/ml
none
3 ppm
(7.8
mg/m
3
)
none
Include in Annex I
and establish an
OEL of 0.1 mg/m
3
in Annex III
1 ppm
(2.6 mg/m
3
)
1 ppm
(4.4 mg/m
3
)
0.01 ppm
(0.013 mg/m
3
)
Sk.
Include in Annex I and
establish an OEL of
0.05 mg/m
3
in Annex
III
n/a
Include in Annex I
and establish an OEL
of 0.2 mg/m
3
in
Annex III
2 ppm
(5.2 mg/m
3
)
5 ppm
(22 mg/m
3
)
0.1 ppm
(0.13 mg/m
3
)
Sk.
n/a
none
n/a
The next section presents an analysis of impacts of the different policy options for each
chemical agent. For reasons of space the analysis for each chemical agent is contained in a table
which is the basis of the comparison ratings presented
74
.
Unless otherwise specified all data in the agent-specific analysis comes from the IOM study,
with reference periods as specified in that study.
5
W
HAT
ARE THE IMPACTS OF THE DIFFERENT POLICY OPTIONS AND HOW DO THEY
COMPARE
?
Before looking at the comparison between different policy options, it should firstly be noted that
the standards of legal control established in the CMD are strict for all in-scope carcinogens,
whether or not entries in Annex I (process generated substances) or Annex III (OELs) have been
established or amended.
The proposed amendments are thus intended to enhance worker protection by improving clarity
for employers and enforcers. The inclusion of chemical agents in Annex I (the list of 'process-
74
The comparison table uses the following ranking symbols: "0" – baseline, "≈" – similar to baseline, "+" more
efficient/effective or coherent than baseline; "++" – much more efficient/effective or coherent than baseline; "-"
– less efficient/effective or coherent than baseline; "- -" – much less efficient/effective or coherent than baseline.
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generated substances') confirms that they fall in scope of the Directive control provisions. OELs
set out in Annex III establish clear compliance benchmarks for exposure control. These
considerations will be inherent in any investment decision, profit projection etc. and should be
based on as much legal clarity as possible.
Concretely, comparing the different policy options requires estimating the effects of introducing
new or more stringent OELs for the chemical agents under consideration. The methodology
followed can be summarised as follows:
In general, the introduction of an OEL is expected to determine a reduction in the
occupational exposure to the carcinogen concerned (as full compliance with the
proposed new OEL is assumed). The extent of such reduction depends on the current
levels of exposure, as well as on the projected future levels of exposure in the absence of
the proposed OEL ("Baseline scenario", corresponding to Option 1).
For a given reduction in exposure levels, it is then necessary to estimate the expected
decrease in the incidence of cancer cases over a given timeframe attributable to the
carcinogen in question. This requires estimates of the risk of carcinogenicity, which can
be derived from the existing toxicological and epidemiological literature, as well as
information about the actual level of worker exposure (numbers, level, duration and
frequency of exposure).
The health benefits of avoided cancer registrations and deaths can then be expressed in
monetary terms by applying standard evaluation methods (value of life years lost, cost of
illness, willingness to pay to avoid cancer). These monetised health benefits can in turn
be compared to the expected monetary costs that would have to be incurred in order to
comply with the proposed OEL. This methodology is further explained in Annex 4.
A number of issues need to be taken into consideration in order to better understand the figures
and conclusions presented in the following sections, which are mostly derived from the results
of the IOM study. As set out above, the CMD requires employers to take measures to protect
workers from occupational use of carcinogens. All stakeholders as consulted in the ACSH are in
favour of the proposed legislative initiative albeit with some differences regarding appropriate
OEL values.
In terms of cost and benefit projection, this renders the updating of the CMD particularly
complex; independent of further clarity under the CMD, employers will include more or less
stringent protection of workers in their facilities, e.g. costly industrial ventilation combined with
personal protective gear. Furthermore, Member States with substantial production involving a
certain carcinogenic chemical agent are likely to introduce national OELs irrespective of EU
action.
In order to take proper account of the cancer latency period (which the IOM study assumes to be
of 10-50 years for solid tumours and of 0-20 years for haematopoietic neoplasms), the future
cancer burden is estimated over a 60 years period.
Looking at the methodological challenges in more detail:
First of all, for most chemical agents under consideration, data on the number of workers
exposed is scarce and unreliable (especially for some sectors and/or for some Member
States), and data on the current exposure levels across EU Member States is generally
not available. Member States record statistics relating to cancer in different ways which
cannot be readily aggregated.
75
Where exposure data is available, its use as an evidence
75
Regulation (EC) No 1338/2008 aims to adopt implementing measures for the relevant domains, including
occupational diseases, provided that the intended data is found to be of sufficient quality. The implementing
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base for regulatory decision-making is often confounded by the sensitive and sometimes
confidential nature of the information, and the potential for source bias.
For many of the carcinogens, the baseline scenario taken from the IOM study foresees a
constant reduction in average exposure levels (e.g. of 7% annually). This projection of
future exposure levels is obtained by extrapolating past declining trends in average
exposure levels. However, for some substances this (large) declining trend assumption is
contested by other studies.
76
In addition, even when declining trends in average exposure
levels are observed, it may be misleading to regard these as exogenous. Recent
reductions in exposure may have been precisely the result of OELs having been
introduced or as an anticipation of those changes. With respect to the cost and benefit
analysis, therefore, the projected decline in average exposure levels under the baseline
scenario may bias the estimated health impacts downward.
The available epidemiologic evidence is scarce and not always sufficiently robust,
inevitably affecting the reliability of the derived estimates for the number of cancer
registrations and deaths. Among the factors contributing to the scarcity of reliable data
are the complexity of cancer development and also of workplace exposures. Different
carcinogens can, for example, result in the same type of cancer (e.g. lung cancer), and
occupational exposure to hazardous agents is characterised by simultaneous exposure to
multiple chemical agents. It can therefore be difficult to establish a causal relationship
between cancer cases and exposure to a specific carcinogen.
The cost-benefit analysis underestimates benefits as only the cancer-related health
impact is considered. Exposure to the chemical agents under consideration is also
associated with additional non-cancer health effects which can induce further health
costs (such as for example neurotoxicity, severe skin damage, respiratory diseases or
renal toxicity).
When a declining trend exposure is considered under the baseline scenario, it would be
incorrect to factor in among the costs of compliance with OELs based on the proposed
OEL the full value of the investment required to reduce exposure: such investment
would have occurred in any case also under the baseline scenario (in order to justify the
decline in exposure), but possibly only later or more gradually over time. As a result the
cost estimates of introducing an OEL reported in the IOM study would be overestimated.
Finally, to allow for a comparison between the monetised health benefits and compliance
costs, the net present values of the streams of costs and benefits over the 60-year period
under consideration are computed. The values originally reported in the IOM study,
based on a constant discount rate of 4%, have been recalculated applying a declining
discount rate (4% for the first 20 years, 3% thereafter) in line with the most recent better
regulation guidelines. Still, benefits estimates are disadvantaged as discounting reduces
much more the present value of impacts taking place in the longer term (typically health
benefits) than those happening at the beginning of the period (typically compliance
costs).
To allow for a better comparison between net health benefits and net compliance costs, as it was
not possible to obtain new estimates of health benefits assuming a constant level of exposure
under the baseline scenario for all chemical agents, the costs presented in the IA report are
measure would require Member States to supply the Commission with statistics on occupational diseases. CMD
Article 14(8) requires that data on cases of cancer resulting from occupational exposure be notified to the
competent national authorities. Statistical practices, however, vary between Member States.
76
Exposure to carcinogens and work-related cancer: a review of assessment methods, EU-OSHA 2014, Available
at https://osha.europa.eu/en/tools-and-publications/publications/reports/report-soar-work-related-cancer/view
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indicative estimates of the actual
additional
costs of compliance assuming some delay (e.g. of
10-20 years) in the realisation of the investment needed to achieve a certain level of compliance.
The lack of reliable exposure data on both the numbers of workers exposed and on the levels of
exposure is recognized. To address this data gap the Commission initiated a study in 2013
77
.
The outcome of this work is expected to contribute to a better definition of the baseline situation
for possible future initiatives on developing OELs for other priority occupational carcinogens.
Analysis of impacted Member States and proportionality
For each of the 13 carcinogens, an analysis of the need for and benefit of action at the EU level
is presented by chemical agent in the following sub-sections (and in Annex 9).
The IOM study identifies the number of EU workers exposed to each chemical agent and, in
most cases, also identifies exposed working populations by Member States. An illustration of
the OELs currently in place at national level is provided in Annex 9, as well as the estimated
number of workers potentially exposed by Member State. Similar information is also
summarised in Table 4 in Annex 6, which identifies the population of workers occupationally
exposed to each chemical agent and compares this to the overall EU population of exposed
workers, resulting in the percentage of workers in the EU for whom legal protection would be
improved by adoption at EU level of an OEL under CMD.
This analysis bears the condition that reliable exposure data is scarce. In particular it should be
noted that it is not possible to identify the proportion of workers in each Member State who may
be employed in tasks where closed system or effective exposure controls are already either
eliminating or reducing exposures below the level represented by the OELs recommended by
ACSH. The probable over-estimation of exposed populations resulting from this data scarcity is
likely to be mitigated by the converse inability to identify specific populations of workers who
may experience exceptionally high exposures.
5.1
1,2 Epoxypropane
This chemical agent is associated with lymphopoietic cancer, haematopoietic cancer and
increased leukaemia risk.
The major use of this chemical agent is to make 1,2 epoxypropane polymers that are used in the
manufacture of polyurethane foams. Its second most important use is in the production of
propylene glycol. About 5% of all 1,2 Epoxypropane production is used in a diverse range of
applications such as the manufacture of surfactants and as a stabiliser for dichloromethane.
The productive capacity within the EU is 2.75 mln tonnes per year and it is produced in 14
facilities in eight Member States (BE, FR, DE, NL, PL, SK, ES and RO). There are estimated to
be 150-300 user facilities across the EU.
Between 35-70 EU workers are estimated to be exposed to 1,2 epoxypropane during its
manufacture and between 450-1,500 EU workers in the chemical industry.
Table 4. 1,2 Epoxypropane – Types of impacts
77
Call for tender no. VT/2013/079. Service contract to create a database and develop a model to estimate the
occupational exposure for a list of hazardous chemicals in the Member States of the European Union and the
EFTA/EEA countries. The contract with the successful bidder, VC/2014/0584, was signed on 23 July 2014.
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Impact Option 1
Baseline: No OEL
Economic
-
Option 2
Option 3
3 78
OEL of 1 ppm (2.4 mg/m )
OEL of 5ppm (12 mg/m
3
)
Costs of compliance not
significant (€1-2k). Few if any
enterprises would require some
additional control measures to
meet the OEL. Any enterprises
that do not currently comply
would need to implement
relatively low-cost measures.
No significant impacts v-à-v
the baseline are expected as
exposure is already largely
below this OEL as the vast
majority of investment
required by industry to comply
with this OEL already
occurred.
Social (incl. health)
Small cost saving (e.g. a few No additional health costs or
€k) from avoided health care benefits.
and reduced cost of illness due
100 attributable YLLs and 110
to reduction in YLLs.
DALYs during 2010-2069
period.
79
,
80
Expected health benefits
mainly in the downstream use
sector, which are expected to
be a share of total health costs
under baseline scenario.
There may be some
environmental impacts related
to humans exposed via the
wider environment, rather than
costs associated with damage
to e.g. ecosystems.
No change compared to
baseline (measures relate to
training and employee
supervision rather than any
additional engineering
controls).
No change compared to
baseline.
Health costs are estimated
between 2.5-10.7 €mln.
Estimates of exposure levels were based on samples obtained during manufacturing and
downstream use in 7 facilities. According to these estimates most companies already comply
with a level of 1 ppm. For those that do not yet comply, the additional costs are expected to be
very low. It is therefore assumed that the introduction of an OEL of 1 ppm would not imply any
important costs associated with compliance, neither major social, macro-economic or significant
environmental impact.
During the ACSH discussions employers' representatives noted that in routine and
manufacturing practices workers' exposures are already well below an OEL of 2 ppm and that a
level of 1 ppm during maintenance and loading operations could be ensured through breathing
personal protective equipment.
Introduction of an OEL of 1 ppm can be expected to be more effective in reducing exposure to
1,2 epoxypropane compared to the baseline, however the monetised health benefits are minor.
Table 5. 1,2 Epoxypropane – Comparison of options
Environmental
Criteria
Baseline
0
Option 2 (1 ppm)
≈
Option 3 (5 ppm)
≈
Effectiveness
78
The study did not assess directly impacts of introducing an OEL of 1 ppm. However, it concluded that impacts
identified for an OEL of 2 ppm would apply equally to an OEL of 1 ppm.
YYL - Years of Life Lost, DALY - Disability Adjusted Life Years – see Annex 4 for further explanation.
According to the IOM Research Project, less than one death per year is predicted from past or future exposure -
100 attributable YLLs during 2010-2069 period.
38
79
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Efficiency
Coherence
Scientific advice
(SCOEL)
ACSH
0
0
1 ppm
1 ppm
≈
+
≈
≈
The scientific advice and the opinion of the social partners and Member States in the ACSH
support option 2, and the CMD further establishes an expectation that OELs be set where it is
possible to do so.
Impact on MS and proportionality
In the case of 1,2 epoxypropane, 26 Member States have so far opted either to not to set a limit
or to set one which is less protective of worker health than the value recommended by ACSH.
Figure 4 in Annex 9 illustrates the ranges of existing national OELs compared to Option 2.
Member States where the production of this chemical agent is concentrated (such as BE, DE,
ES, FR, NL, PL, RO and SK)) have no OEL or OELs above the proposed limit value.
Introducing an OEL would bring a greater clarity for economic operators across the EU and
ensure that lack of an OEL or a less stringent OEL does not act as an incentive for business in
decisions concerning the plant location.
The introduction of an OEL of 1 ppm would require changes to the national frameworks of most
MS. Due to the generally low number of exposed workers across the EU, no estimates were
made about the numbers of exposed workers in those 26 MS. Even if current exposure levels in
the EU are estimated to be well below 2 ppm, a minimum basis of protection against the risks
arising from workers' exposure to these carcinogens cannot be ensured under the baseline for all
EU workers – it follows that an action taken at the European Union level to achieve this
objective is proportionate.
5.2
1,3 Butadiene
This chemical agent is associated with an increased risk of lymphohaematopoietic cancer,
mainly lymphosarcoma.
Most 1,3 butadiene is polymerized at a relatively small number of sites in Europe to form
synthetic rubber. It is also used as a chemical intermediate in the production of neoprene for
automotive and industrial rubber goods, in the production of methylmethacrylate-butadiene-
styrene polymer, which is used as a PVC reinforcing agent, and in the production of adiponitrile
(a nylon precursor). The production capacity in the EU is estimated to be 2.9 mln tonnes.
There were nine plant sites producing emulsion of SBR in July 2010 (IOM report), four
producing solution of SBR, seven producing polybutadiene or butadiene rubber and six
producing nitrile butadiene rubber. Some of the sites produce two or more of these elastomers at
the same location. All companies affected by the proposed OEL value of 1ppm would be SMEs,
and the great majority of them (about 90%) would be microenterprises (less than 10 employees).
About 27,600 workers in the EU are estimated to be potentially exposed to this chemical agent.
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Table 6. 1,3 Butadiene – Types of impacts
Impact Option 1
Baseline: No OEL
Economic
A 7% annual
decline in exposure
levels assumed, so
that by 2030 90%
of high exposed
jobs estimated to
be below 0.6 ppm.
Costs are expected
due to further
spending on
control measures
to reduce exposure
(e.g. improving
working practice,
improved
ventilation,
improved loading/
unloading
equipment).
Social (incl. health)
Option 2
OEL of 1 ppm
(2.2 mg/m
3
)
It is estimated that
2% of enterprises
(159 enterprises)
will require some
form of control
measure to meet
the proposed OEL.
Investment is
expected to occur
already under the
baseline, only
possibly later in
time: the costs of
anticipating this
expenditure by 10-
20 years would be
in the range of 5.8 -
37.8 mln €.
No plant closures
foreseen.
Estimated health
benefits in addition
to those under
baseline are
between 0.2 to 0.6
mln €.
No avoided deaths
or cancer
registrations, nor
changes in
DALYs, but 10
less YLLs
estimated over
2010-2069 period
compared to
baseline.
Option 3
OEL of 0.5 ppm
(1.1 mg/m
3
)
It is estimated that
4% of enterprises
(251 enterprises)
will require some
form of control
measure to meet
the proposed OEL.
Investment is
expected to occur
already under the
baseline, only
possibly later in
time: the costs of
anticipating this
expenditure by 10-
20 years would be
in the range of 9.2-
59.9 mln €.
No plant closures
foreseen.
Estimated health
benefits in addition
to those under
baseline are
between 0.2 to 0.6
mln€.
No avoided deaths
or cancer
registrations, but
20 less YLLs and
10 less DALYs
estimated over
2010-2069 period
compared to
baseline.
Behavioural
change
amongst
employees
and
updating
health
and safety training
will be required.
Option 4
OEL of 5 ppm
(11 mg/m
3
)
It is estimated that less
than 0.3% of enterprises
(19 enterprises) will
require some form of
control measure to meet
the proposed OEL.
Investment is expected to
occur already under the
baseline, only possibly
later in time: the costs of
anticipating this
expenditure by 10-20 years
would be in the range of
0.7-4.4 mln €.
No plant closures foreseen.
Estimated health
costs between 41
€mln (low
scenario) and 167
€mln (high
scenario) in the
period 2010-2069.
YLLs: 1,320
DALYs: 1,640
Estimated health benefits
in addition to those under
baseline are between 0 to
0.1 mln €.
No avoided deaths or
cancer registrations, but 10
more YLLs and 20 more
DALYs estimated over
2010-2069
period
compared to baseline.
Behavioural change
amongst employees and
updating health and safety
training will be required.
Some
personnel
may change their
working practices
(e.g.
wearing
respiratory
protective
equipment)
to
Behavioural
reduce risks of
change
amongst
inhalation
employees
and
exposure.
updating health and
safety training will
be required.
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Impact Option 1
Baseline: No OEL
Environmental
Not estimated.
Option 2
OEL of 1 ppm
(2.2 mg/m
3
)
Possibly more
direct emissions
(through
ventilation) but
overall
environmental
burden should not
increase.
Option 3
OEL of 0.5 ppm
(1.1 mg/m
3
)
As in option 2.
Option 4
OEL of 5 ppm
(11 mg/m
3
)
As in option 2.
The exposure levels were estimated across the industries of manufacture of refined petroleum
products and manufacture of rubber. The estimates of exposure levels in the manufacture of
refined petroleum products (NACE code 23) were based on different studies covering Finland,
13 EU countries, EU and UK. The estimates of exposure levels in the rubber industry (NACE
code 251) were based on studies in 27 EU plants, in the Netherlands, Finland and Czech
Republic.
Given the estimated decreasing exposure levels to 1,3 Butadiene in the baseline scenario and the
fact that it is not possible to identify an exposure level at which there is no risk of
lymphohaematopoietic cancer, none of the assessed options would allow a reduction in the
numbers of attributable deaths or cancer registrations in the 2010-2069 period. However,
introducing an OEL would be effective in ensuring a greater clarity for economic operators
across the EU. Option 4 is the least effective as it is estimated to slightly increase the number of
years of life lost (YLL) over the 2010-2069 period as compared to the baseline scenario, while
YLL are expected to slightly decrease under options 2 and 3. Of those two, option 2 brings
about the least additional costs for enterprises.
Employers' representatives at the ACSH accepted the option of an OEL of 1 ppm as feasible
while expressing concerns about potential economic impacts of lowering an OEL below that
level.
Table 7. 1,3 Butadiene – Comparison of options
Criteria
Baseline
Option 2
1 ppm
≈/+
-
+
Option 3
0.5 ppm
+
--
+
Option 4
5 ppm
≈
≈
≈
Effectiveness
Efficiency
Coherence
Scientific advice
(SCOEL)
ACSH
0
0
0
Additional leukaemia risk with 1ppm exposure for a 40-year working life: from
0 to 10.78 extra leukaemia deaths between ages 25-85 years.
1 ppm (=2.25 mg/m3) to be reviewed. A revision to be conducted in 3 years.
The opinion of the social partners and Member States in the ACSH supports option 2, and the
CMD further establishes an expectation that OELs be set where it is possible to do so.
Introducing an OEL would also be effective in introducing a greater clarity for economic
operators across the EU. An OEL of 1 ppm is also set in the US.
Impact on Member States and proportionality
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In the case of 1,3 Butadiene 23 Member States have no OEL or one that is less stringent than the
ACSH recommended 1 ppm level. Figure 5 in Annex 9 illustrates the ranges of existing national
OELs compared to Option 2. The following Figure 6 shows distribution of exposed workers
across the Member States.
The Member States where the production or use of this substance is concentrated (such as DE,
FR, UK, ES, PL, RO) have no OEL or OELs above the proposed limit value. Introducing an
OEL would bring a greater clarity for economic operators across the EU and ensure that lack of
an OEL or a less stringent OEL does not act as an incentive for business in decisions concerning
the plant location.
The introduction of an OEL of 1 ppm would require changes for a substantial number of
Member States. It is estimated that approximately 93% of exposed workers are located in those
23 Member States. Even if current exposure levels in the EU are estimated to be well below 2
ppm, a minimum basis of protection against the risks arising from workers' exposure to these
carcinogens cannot be ensured for all EU workers under the baseline scenario – it follows that
an action taken at the European Union level to achieve this objective could be justified.
5.3
2 Nitropropane
According to animal toxicity studies 2 nitropropane may cause liver tumours in humans.
Occupational exposures to this chemical agent occur primarily in its production and use as a
solvent in inks, adhesives, paints and coatings. It is produced in relatively low volumes.
According to the IOM report there was only one plant in Germany which produced 2-
nitropropane. In downstream uses exposures were considered only likely to occur in the
manufacture of aircraft and spacecraft (NACE code 35.3) and possibly at very low levels in the
recycling of non-metal waste and scrap (NACE code 37.2).
No information on EU total production is available.
About 51,400 EU workers are estimated to be exposed to 2 nitropropane.
Table 8. 2 Nitropropane – Types of impacts
Impact
Option 1
Baseline: No OEL
It is assumed that exposures will fall by 7%
per year in the future. Therefore, there are
expected to be some costs for firms to put into
place employee training, PPE and ventilation
measures to reduce inhalation and dermal
exposure.
Option 2:
OEL of 5ppm (18.25 mg/m
3
)
No significant additional costs for firms since
under the baseline scenario it is estimated that
firms are already achieving exposures below 5
ppm. Neither additional health costs nor
benefits are expected, as exposure is already
estimated to be below an OEL of 5 ppm.
Economic
Not possible to estimate health impact as there None, as exposure already estimated to be
is
no
epidemiological
evidence
of below the possible OEL.
carcinogenicity
in
humans.
However,
probably low, considering low and decreasing
exposure in the EU.
No significant.
No significant.
Environm
ental
Social (incl.
health)
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Estimates of exposure were assumed to decrease by 7% per annum (reference: Creely et al.
2007). The estimates for 2010 exposures were based on worst-case measurements
obtained/reported in 1984 from the industries of manufacture of 2-nitropropane and of
automotive manufacturing.
Given the estimated low exposure levels (it is likely that no worker in the EU is exposed in
excess of the proposed limit value of 5 ppm), option 2 is expected to have no health impact. For
the same reason, establishing this OEL at EU level would not impose additional costs on firms,
while remaining a measure in terms of promoting a levelled playing field for companies across
the EU.
Table 9. 2 Nitropropane – Comparison of options
Criteria
Option 1
Baseline
Option 2
5 ppm
≈
≈
+
Effectiveness
Efficiency
Coherence
Scientific advice
(SCOEL)
0
0
0
SCOEL advice is currently being developed.
IOM Study considered 5 ppm (18 mg/m
3
) for assessment, as 'typical' values
for existing national OELs in the EU.
5 ppm (=18.25 mg/m
3
)
ACSH
The opinion of the social partners and Member States in the ACSH supports option 2, and the
CMD further establishes an expectation that OELs be set where it is possible to do so.
Introducing an OEL would also be effective in introducing a greater clarity for economic
operators across the EU.
Impact on Member States and proportionality
In the case of 2 Nitropropane 14 Member States have so far opted either to not to set a limit or
to set one which is less protective of worker health than the value recommended by ACSH. The
Figure 7 in Annex 9 illustrates the ranges of existing national OELs compared to Option 2. The
following Figure 8 shows distribution of exposed workers across the Member States.
Some of the Member States where production or use of this chemical agent is concentrated and
therefore where the numbers of exposed workers are the highest (such as DE, FR, PL or IT)
have no OEL or OELs above the proposed limit value. UK and ES have OELs, which are
slightly higher than Option 2. Introducing an OEL would bring a greater clarity for economic
operators across the EU and ensure that lack of an OEL or a less stringent OEL does not act as
an incentive for business in decisions concerning the plant location.
81
Introduction of an OEL of 5 ppm would require changes for a substantial number of MS. It is
estimated that approximately 62% of exposed workers are located in those 14 Member States.
Even if current exposure levels in the EU are estimated to be below 5 ppm, a minimum basis of
protection against the risks arising from workers' exposure to these carcinogens cannot be
ensured for all EU workers under the baseline scenario. It follows that an action taken at the
European Union level could be justified.
81
See Figure 7 - 2 Nitropropane – Current national OELs vs. Option 2 ; and Figure 8 - 2 Nitropropane –Number of
exposed workers
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5.4
Acrylamide
Acrylamide may cause pancreatic cancer, and is also a skin irritant and may be a tumour
initiator in the skin, potentially increasing risk for skin cancer.
99% of acrylamide in the EU is used in the production of polyacrylamide
82
. The main uses of
polyacrylamide are in wastewater treatment, paper and pulp processing and mineral processing.
Three companies are reported as producing acrylamide within the EU (in UK, Germany and the
Netherlands). There were also thought to be firms in Spain, Finland and Italy who either supply
(from imports) or produce acrylamide. The total plant capacity within the EU is estimated at
between 80,000-150,000 tonnes per annum. The IOM report found seven producers of
polyacrylamide within the EU (two of which also produced acrylamide), as well as a number of
smaller producers throughout the EU.
54,000 EU workers are estimated to be exposed to acrylamide.
It should be noted that the global market for polyacrylamide has been growing and is expected
to continue expanding.
83
Table 10. Acrylamide – Types of impacts
Impact
Option 1
Baseline: no OEL
Exposures expected to
continue falling by 10.5%
per year in the manufacture
of chemicals and chemical
products sector.
Option 2
OEL of 0.1 mg/m
3
, Sk.
No additional economic
costs, since industry already
expected to comply with an
OEL of 0.1 mg/m
3
.
Option 3
OEL of 0.03 mg/m
3
, Sk.
No additional economic costs,
since industry already expected to
comply with an OEL of 0.03
mg/m
3
.
Total attributable deaths between
2010-2069: 230
Economic
Social (incl. health)
Total health costs estimated Total attributable deaths
at €156-326mln.
between 2010-2069: 230
Total attributable deaths
between 2010-2069: 230
YLLs between 2010-2069: YLLs between 2010-2069: 3,410
3,410
DALYs between 2010-2069:
YLLs between 2010-2069: DALYs between 2010-
3,480
3,410
2069: 3,480
No additional health benefits
DALYs between 2010- No additional health
expected as compared to the
2069: 3,480
benefits expected as
baseline scenario, since industry
compared to the baseline
already expected to be complying
scenario, since industry
with this OEL.
already expected to be
complying with this OEL.
No change.
No change.
Estimates of exposure levels are based on a study by Bull et al. (2005), who monitored personal
inhalation and dermal exposure at a UK acrylamide and polyacrylamide manufacturing facility,
based on measurements between 1992 and 1995. The results of this study were extrapolated to
82
83
Environm
ental
It should be noted that a targeted REACH restriction applies to placing on the market or use of acrylamide
(above a certain concentration) in grouting applications, which is prohibited. While this restriction is relevant
for worker protection, it should not be expected to significantly affect the overall exposure patterns and
associated cost benefit assessments made in this report.
See Figure 9 – Acrylamide - Global polyacrylamide market, 2012-2019 (in 1,000 tonnes) (Annex 9).
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the whole acrylamide and polyacrylamide manufacturing industry in the baseline scenario even
if the 10.5% annual decline rate appears optimistic.
On this basis it is assumed that industry is already complying with an OEL of 0.03 mg/m
3
, and
thus no major health impact is to be expected from any of the two options. No economic cost is
expected for the implementation of any of both options, although, if any, this would be even
lower for an OEL of 0.1 mg/m
3
compared to a more stringent OEL of 0.03 mg/m
3
.
Where there is the possibility of a significant uptake via dermal exposure SCOEL recommend
that any OEL be accompanied by a 'skin notation' (in the case of acrylamide ACSH did not
comment on this aspect of the SCOEL Recommendation). If adopted and accordingly
transposed by Member States, employers are required under the national transposing legislation
to take this into account in selecting appropriate risk management measures to protect workers.
Once the need for managing exposure has been established the only risk management measure
available in practical terms is to avoid skin contact. Acrylamide has a harmonised classification
as a skin irritant (category 2) and skin sensitiser (category 1). These hazards would normally
result in employers taking steps to avoid skin contact as a part of routine OSH risk control.
Adoption of a 'skin notation' should therefore result in no additional cost for employers.
Table 11. Acrylamide – Comparison of options
Criteria
Baseline
Option 2
0.1 mg/m
3
, Sk.
≈
≈
+
Option 3
0.03 mg/m
3
, Sk.
≈
≈
+
Effectiveness
Efficiency
Coherence
Scientific advice
(SCOEL)
0
0
0
Genotoxic carcinogen for which the existence of a threshold cannot be
sufficiently supported. A reasonable quantitative cancer risk assessment for
humans is not feasible.
Any regulation that may be established for acrylamide should also be
protective against the development of neurotoxicity. While it is difficult to
establish a dose-response for neurotoxicity in occupational studies a 'no
observed affect level' for neurotoxicity resulting from airborne exposure at
about 0.1 mg/m
3
or 0.035 ppm (8-hour TWA) can be inferred.
Dermal absorption is important in relation to workers under practical working
conditions, and a ‘skin’ notation is therefore warranted.
ACSH
A range from 0,07 to and including 0,1 mg/m
3
, with a review period of 3
years.
The opinion of the social partners and Member States in the ACSH supports option 2, and the
CMD further establishes an expectation that OELs be set where it is possible to do so.
Introducing an OEL would also be effective in introducing a greater clarity for economic
operators across the EU.
Impact on Member States and proportionality
In the case of acrylamide 13 Member States have so far opted either to not to set a limit or to set
one which is less protective of worker health than the value recommended by ACSH. Figure 10
in Annex 9 illustrates the ranges of existing national OELs compared to Option 2. The following
Figure 11 shows distribution of exposed workers across the Member States.
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The three Member States where the production and/or use of this chemical agent is concentrated
and the numbers of exposed workers are the highest (DE, UK or FR) have no OEL or OELs
above the proposed limit value of 0.1 mg/m
3
. Introducing an OEL would bring a greater clarity
for economic operators across the EU and ensure that lack of an OEL or a less stringent OEL
does not act as an incentive for business in decisions concerning the plant location.
Introduction of an OEL of 0.1 mg/m
3
would require changes for a substantial number of
Member States. It is estimated that approximately 64% of exposed workers are located in those
13 Member States. Even if current exposure levels in the EU are estimated to be below 0.03
mg/m
3
, a minimum basis of protection against the risks arising from workers' exposure to these
carcinogens cannot be ensured for all EU workers under the baseline. It follows that an action
taken at the European Union level could be justified.
5.5
Hardwood dust
Hardwood dust is listed in the CMD but not classified according to the EU CLP regulation
(because it is a PGS); however it is classified as a Group 1 carcinogen ("carcinogenic to
humans") by the International Agency for research on cancer. Hardwood dust may cause
sinonasal and nasopharyngeal cancers. In addition, hardwood dust may cause non-malignant
respiratory health problems, including occupational asthma.
Exposure to hardwood dust occurs mainly in the wood working industry, furniture
manufacturing and construction sectors. Over three million EU workers are potentially exposed
in over 340 000 companies, mostly SMEs, with a production value of around €230 bln/year.
The estimates of the prevalence and level of exposure to hardwood dust were based on the
results of the 2001-2006 WOODEX project and on the timber statistics UNECE. The
WOODEX project aimed at estimating occupational exposure to inhalable wood dust by
country, industry, level of exposure and type of wood dust in 25 Member States. National labour
force statistics, a country questionnaire (in 15 Member States, EU-15), a company survey (in
Finland, France, Germany and Spain), exposure measurements (from Denmark, Finland, France,
Germany, the Netherlands and the United Kingdom), and expert judgments were used to
generate preliminary estimates of exposure to different types of wood dust. These estimates
were reviewed and finalised by national experts from 15 Member States.
The study showed that construction employed 33% of exposed workers, mostly construction
carpenters. 20% of exposed workers worked in the furniture industry, 9% in the manufacture of
builders’ carpentry, 5% in sawmilling, 4% in forestry. In addition, 20% were employed in
miscellaneous industries employing carpenters, joiners, and other woodworkers. The numbers of
exposed workers varied by country ranging from <3,000 in Luxembourg and Malta to 700,000
in Germany. According to the IOM report, the countries with the highest numbers of exposed
workers are Germany (19.75% of all EU workers), Spain (12.18%), the UK (19.91%), Italy
(9.88%) and Poland (9.29%).
The WOODEX study concluded that the high wood dust concentrations were measured in the
furniture industry, in the manufacture of other wooden products, and especially in construction.
The mean wood dust concentrations were in fact the highest in construction. Regarding the
manufacture of wood products industry, the IOM report estimates that more than 88% of
enterprises have between 1 and 9 employees, while only 1.5% have between 50 and 250
employees. The furniture manufacturing sector is similarly mostly composed of very small
enterprises (86% with 1 to 9 employees) and few large companies (2.3% with 50 to 250
employees).
Table 12. Hardwood dust – Types of impacts
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Impact
Option 1
Option 2:
Option 3:
OEL of 1 mg/m
3
Additional costs for firms are
expected compared to the
baseline, as the OEL will require
changes in manufacturing
processes and installation of
compliant ventilation systems.
Depending on the anticipation of
additional investments following
the baseline investments (10 or
20 years), those additional
compliance costs could be
ranging from €13 bln to 52 bln.
Such costs risk
disproportionately affecting
SMEs, possibly forcing some of
them out of business or forcing
firms to shift to other materials to
avoid compliance costs.
Total attributable
deaths/YLL/DALYs for 2010-
2069: data not conclusive
Net health benefits in addition to
those under the baseline are
estimated to range between €66-
325mln.
New ventilation system would
require training and maintenance
efforts, with a small impact as
85% of firms are estimated to
already have ventilation in place.
New ventilation could positively
improve working conditions.
There are no foreseen changes in
the end products.
none
Baseline: OEL at 5 OEL of 3 mg/m
3
mg/m
3
Economic
Exposures will continue
falling by 8% per year.
Some costs to put into
place ventilation
measures expected for
firms.
It is considered that EU
industry is already compliant
with an exposure limit of 3
mg/m
3
. According to the IOM
Study no additional
significant costs for firms vs.
the baseline are expected
since the average exposure
across sectors is lower than
this limit and no change in
the manufacturing processes
are foreseen because of a
lower OEL.
Social (incl.health)
The health costs
associated with no action
up to 2069 are estimated
to between €3bln and
16bln, which fall mainly
on DE, FR, IT, SP and
UK.
Total attributable deaths
for 2010-2069: 5000.
Total attributable
deaths/YLL/DALYs for
2010-2069: data not
conclusive
84
Net health benefits in
addition to those under the
baseline are estimated to
range between €12mln and
54mln.
No significant change to
current employment and
working conditions is
foreseen.
There are no foreseen
changes in the end products.
Environ
mental
none
none
Assumptions concerning declining exposure trends in the IOM study were based results of two
studies – one from UK, another from the US, both showing steady decrease of exposures over
approximately 20 years' period. It should be noted however, that other studies do not support the
resulting estimate of current compliance with an exposure level of 3 mg/m
3
. The WOODEX
project provides data on numbers of exposed workers in the EU as well as on levels of
84
Analysis of the data on deaths and cancer cases from the IOM study showed some inconsistencies, which led to
the decision to limit the impact analysis to monetised health benefits.
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exposure
85
. The WOODEX data on levels of exposure for 2000-2003, shows that 25% of all
affected workers are exposed to a level of 2-5 mg/m
3
(897 000 workers) and as much as 16% are
even exposed to levels higher than the legally binding 5 mg/m
3
(563 000 workers). In
construction, which has the highest number of exposed workers (1,190,000), the proportion of
those exposed to levels higher than 5 mg/m3 reaches 21% or 254 000 workers.
Option 3 would be the most effective option in reducing occupational exposure to carcinogens.
It also leads to the highest reduction of estimated health costs. However, it does so at the cost of
imposing a disproportionate burden on firms and in particular SMEs. It may force SMEs to use
other type of material or to close down business. On the other hand, option 2 should lead as well
to a substantial reduction in the health costs, while the negative impact on firms remains very
low or non-existent. Thus, option 2 is the best scoring option in terms of efficiency.
The impact on mobile machinery might be higher than on stationary machinery as it is
considered, based on the results of a report by the French authority quoted in the IOM study,
that more companies have already put in place ventilation systems for stationary machinery than
they have for mobile machinery. Moreover, concentration exposures vary according to sectors
and occupation. It is estimated that the highest concentrations (2-3 mg/m
3
) are in the
construction sectors, while for the other sectors concentrations are estimated to be generally
below 1 mg/m
3
for those working far from machinery in control rooms or maintenance tasks.
Exposure concentrations for installers and carpenters across all industries were generally
estimated to be between 2-3 mg/m
3
. Therefore it is assumed that there will not be any significant
cost to most enterprises to meet Option 2. However, data is missing to assess the impact of the
OEL on non-substitutable hand-held machines and whether there are alternative solutions to
ensure that exposure levels will be properly implemented. Employers emphasised that some
hand-held machinery does not allow going below 5 mg/m
3
. On the other hand the workers
favoured a 2 mg/m
3
limit in view of current limit values of 2 mg/m³ or below in the majority of
Member States. For some MS, 3 mg/m
3
is at the limit of feasibility particularly for SMEs while
other MS favour a 1 mg/m
3
limit to further reduce occupational cancer cases.
Hardwood exposure is also associated with increased symptoms of the upper respiratory tract
and to allergic (asthma) and non-allergic effects in the lower respiratory tract. As explained
above, the direct and indirect costs of illnesses other than cancer were not taken into account in
the IOM evaluation of the health costs and benefits, leading to a clear under-estimation of the
health costs benefits of introducing a lower OEL. A 2014 British study
86
showed that
occupational asthma had a poor prognosis; once a worker develops occupational asthma after a
latency period the chances of recovery are small. The average direct costs per annum per case
were found to range from £530 to £715 (670 to 900€), whereas the indirect costs range from
£1525 to £1685 (1930 to 2140 €).
Table 13. Hardwood dust – Comparison of options
Criteria
Option 1:
Baseline
OEL at 5 mg/m
3
Option 2:
OEL at 3 mg/m
3
+
++
+
Option 3:
OEL at 1 mg/m
3
++
--
+
Effectiveness
Efficiency
Coherence
85
0
0
0
Exposure to carcinogens and work-related cancer: a review of assessment methods, EU-OSHA 2014, Available
at https://osha.europa.eu/en/tools-and-publications/publications/reports/report-soar-work-related-cancer/view
Montano D. Chemical and biological work-related risks across occupations in Europe: a review. Journal of
Occupational Medicine and Toxicology (London, England). 2014;9:28. doi:10.1186/1745-6673-9-28.
48
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Scientific advice
(SCOEL)
ACSH
1 mg/m
3
(inhalable dust) is probably below the levels to which the cases of
sino-nasal cancers had been exposed.
3 mg/m
3
, measured as inhalable dust, with a review period of between 3-5
years is proposed.
The preferred option is 2 (3 mg/m
3
) because it is the most cost-effective and at the same time is
the level which came out of the discussions between employers, employees and MS
representatives at ACSH discussions.
Impact on Member States and proportionality
In the case of hardwood dust 18 Member States have so far opted to set a limit which is less
protective of worker health than the value recommended by ACSH. Figure 12 in Annex 9
illustrates the ranges of existing national OELs compared to Option 2. The following Figure 13
shows distribution of exposed workers across the Member States.
Among the six Member States with the highest numbers of exposed workers, three have an OEL
which is less protective than the value proposed by the ACSH (ES, UK, IT) and thus there is a
case of competitive advantage compared to Member States which have adopted more stringent
measures. On the other hand, the fact that an OEL at 3 mg/m
3
or below is already in place in the
other three Member States with high numbers of exposed workers (DE, PL and FR) as well as in
six other Member States (AT, BE, CZ, DK EE, NL, SE) indicates that solutions exist to
practically implement the OEL. An even lower OEL exists for example in Switzerland (2
mg/m
3
) as well as in Canada and Australia (1 mg/m
3
).
It should also be noted that as more than 75% of workers exposed to wood dust are exposed to
both hardwood and softwood dusts, the prevention of the risks posed by hardwood dust will also
include softwood dust. So in practice, the OEL on hardwood dust would also be beneficial to
protection against exposure to softwood dust.
Introduction of an OEL of 3 mg/m
3
would require changes for a substantial number of MS. It is
estimated that approximately 48% of exposed workers are located in those 18 Member States.
Even if it is estimated that EU industry is already compliant with an exposure limit of 3 mg/m
3
,
which appears to be an optimistic assumption when the WOODEX data is taken into account, an
action at EU level could provide a minimum basis of protection against the risks arising from
workers' exposure to these carcinogens for a significant proportion of workers at risk.
5.6
Chromium (VI) compounds
Occupational exposure to chromium (VI) compounds – also known as hexavalent chromium
compounds - has been associated with an increased risk of lung cancer and sinonasal cancer.
Hexavalent chromium compounds are no longer manufactured in Europe and they are imported
less than in the past. The main use of hexavalent chromium is found in wood preservatives,
metal coatings, chromium production and catalyst manufacture. In 2006 about 917,000 workers
in the EU were exposed. Since 2006, hexavalent chromium has been banned for certain uses (for
instance in new vehicles or electronic equipment); the number of workers with high level of
exposure is likely to have declined further since then.
The number of workers' exposed to hexavalent chromium was estimated on the basis of the
Finnish, Spanish and Italian CAREX estimates. The proportion of exposed workers in each
industry was taken from each of these three CAREX estimates and the average proportion
exposed across all three countries was found for each industry. The average proportion of
exposed workers was applied to information on the number of employees in each industry
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obtained from Eurostat. To find the number of exposed workers in each industry in each country
the average proportion of exposed workers in those three countries was used and multiplied by
the number of workers employed in each industry in each country in 2006.
There are no current hexavalent chromium exposure level data available. Exposure levels
presented are the result of the analysis done on a sample taken between 1990 and 1999, with
geometric mean exposure representative of 1995. The 2010 geometric mean exposures was
extrapolated from the 1995 geometric mean exposure based on an estimated decrease in
exposure of 7% per year. Due to the limited availability of exposure data it is not possible to
present a systematic description of differences in exposure across the EU. The assumption used
to determine exposure of different countries consider the extrapolated 2010 exposures level in
high exposure industry groups (Table 17) as typical of exposures throughout the EU.
The exposure data available for high exposure NACE industries 27, 28 and 35 were collected
from the UK National Exposure Database (NEDB) and data for NACE 24 were compiled for the
EU Risk Assessment Report for Chromates using data from industry and the HSE NEDB. No
data were found for NACE 28 but exposures are likely to be very similar to NACE 28
87
.
A subset of chromium (VI) compounds (out of over 100), as shown in table 14, are listed in
Annex XIV of the REACH Regulation and so are, or will be, subject to 'authorisation' for
continued use.
Table 14. Chromium (VI) compounds currently in REACH Annex XIV
Substance
Trichloroethylene
Chromium trioxide
Chromic acid, oligomers of chromic acid and
dichromic acid, dichromic acid
Sodium dichromate
Potassium dichromate
Ammonium dichromate
Potassium chromate
Sodium chromate
CAS No.
1979-1-6
1333-82-0
7738-94-5; 13530-68-2
7789-12-0; 10588-01-9
7778-50-9
7789-9-5
7789-00-6
7775-11-3
EC No.
201-167-4
215-607-8
231-801-5; 236-881-5
234-190-3
231-906-6
232-143-1
232-140-5
231-889-5
Available evidence (e.g. from the CAREX database) indicates that sodium, potassium, calcium
and ammonium chromates and dichromates have been identified as the most important in terms
of workers' exposures, a number of which are already regulated under REACH.
It is not possible based on available data to identify exposed populations or impacts associated
only with chromium (VI) compounds which are not listed on REACH Annex XIV, nor to
account for the impact REACH authorisation may have on exposures for those important
compounds to which it will apply.
The IOM study assessed impacts of introducing an OEL for all chromium (VI) compounds,
including those subject to REACH.
While this analysis is based on best available data, it should be noted that this results in likely
overestimates of both the costs and benefits associated with setting an OEL under CMD for
chromium (VI) compounds.
87
Exposures in these NACE groups are similar because arise chiefly from welding and other hot work with
stainless steel.
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Table 15. Chromium (VI) compounds – Types of impacts
Impact
Economic
Option 1
Baseline - no OEL
It is assumed that
exposures will fall by
7% per year in the
future. Therefore, there
are expected to be
some costs to firms
where hexavalent
chromium exposure
requires firms to put
into place ventilation
measures to reduce
inhalation exposure.
These would occur
regardless of further
intervention over the
period 2010 – 2069.
Option 2
OEL of 0.025 mg/m
3
It is estimated that 27% of
enterprises will require some
form of control measure to meet
the proposed OEL (estimate for
all chromium (VI) compounds).
It is assumed that the majority of
those will require ventilation
systems to reduce exposure levels
to meet the OEL.
Investment is expected to occur
already under the baseline, only
possibly later in time: the costs of
anticipating this expenditure by
10-20 years would be in the
range of €13.4bln-€52.3 bln.
However, there appears to be a
significant burden on SMEs.
The up-front capital cost of a
ventilation system is estimated to
be in the region of €42k -252k.
This is likely to be a significant
cost which may potentially result
in those companies stopping their
use of chromium or forcing the
closure of some companies, if
they are dependent upon the use
of hexavalent chromium and are
unable to make the necessary
investment to achieve appropriate
levels of to protect workers'
health.
Option 4
OEL of 0.05 mg/m
3
It is estimated that 16% of
enterprises will require some
form of control measure to
meet the proposed OEL. It is
assumed that the majority of
those will require ventilation
systems to reduce exposure
levels to meet the OEL.
Investment is expected to
occur already under the
baseline, only possibly later
in time: the costs of
anticipating this expenditure
by 10-20 years would be in
the range of €3.6bln-€13
bln.
However there appears to be
a significant burden on
SMEs. The up-front capital
cost of a ventilation system is
estimated to be in the region
of €42k - 252k. This is likely
to be a significant cost,
which may potentially result
in those companies stopping
their use of chromium or
forcing the closure of some
companies, if they are
dependent upon the use of
hexavalent chromium.
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Social (incl. health)
23,640 work-related
cancer cases are
expected to be
registered in the period
2010-2069.
No. of deaths from
lung and sinonasal
cancer in: 17,370.
The health costs over
the period 2010-69 are
estimated to be around
€8.6-27bln.
As it is assumed that
exposures fall by 7%
per year in the future,
there is expected to be
a significant reduction
in health costs going
forward in the absence
of further regulatory
intervention.
1810 cancer cases would be
avoided compared to the
baseline.
No. of avoided deaths from lung
and sinonasal cancer in 2060:
1670.
There are expected to be benefits
from avoided health care and
reduced cost of illness due to
reductions in cancer registrations.
The benefits are most apparent
from 2040 onwards. Total
benefits are estimated at
€591mln-1.7 bln.
1320 cancer cases would be
avoided compared to the
baseline.
No. of avoided deaths from
lung and sinonasal cancer in
2060: 1240.
There are expected to be
benefits from avoided health
care and reduced cost of
illness due to reductions in
cancer registrations.
The benefits are most
apparent from 2040 onwards.
Total benefits are estimated
at €440mln-1.3bln.
Environmental
It is considered that the
controls in place to
control environmental
emissions are sufficient
to control the potential
risks to the
environment.
No different to the baseline.
Not different to the baseline
The baseline scenario for all industries assumes a 7% annual decline in exposure levels and
standards change in employed numbers up to the 2021-30 estimation interval. Due to cancer
latency, cancer cases - derived as a consequence of past exposure - will continue to affect
workers' population until 2030. This situation urges a timely intervention in regulating exposure
levels since the introduction of an EU-wide OEL could have a significant positive long-term
impact on workers' health. The number of future cancer cases can be most substantially
decreased through full compliance with an OEL of 0.025 mg/m
3
. In addition to the importance
of combating cancer it should be noted that the chemical agents may cause other adverse health
effects at comparable threshold levels including nasal irritation, severe skin damage or renal
toxicity.
Figure 14 in Annex 9 synthetises the changes in the valence state of chromium at all stages of
industrial use from mining production, to downstream industry activity and to end use.
Hexavalent chromium and trivalent chromium have been coloured coded to emphasise the
different states of chromium at the different stages of use.
88
In 2005 the main industrial uses of the chromium (VI) compounds are summarised in Table 16.
In 2007 the last EU producer of hexavalent chromium compounds, located in the UK, closed
down following declines in the market.
88
See Figure 14. Overview of Chromium Valence State in Chromium Applications (annex 9).
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Table 16. Main industrial uses of the chromium (VI) compounds
Source: HSE (2007) Human Health Risk Reduction Strategy for Chromates in IOM (2011) Hexavalent Chromium, pp. 5
In the EU certain industries have been classified as high in terms of workers exposure to
hexavalent chromium. These industries, grouped by NACE code, were identified from CAREX
data and are summarised in the table below.
Table 17. Classification of Industries with High Level Exposure
Industry
Manufacture of chemicals and
chemical products
Manufacture of basic metals
Manufacture of fabricated metal
products, except machinery and
equipment
Manufacture of machinery and
equipment n.e.c.
Manufacture of other transport
equipment
Manufacture of furniture;
manufacturing n.e.c.
NACE Historical Exposure
Classification
24
27
28
High
High
High
Number of People
Exposed in 2006
42452
29670
288480
29
35
36
High
High
High
134067
41643
15942
Compliance cost analysis shows that the majority of firms within affected industries would meet
the most stringent proposed OEL (0,025 mg/m
3
) given that the estimated geometric mean (2010)
is between 0.002-0.005 mg/m
3
. However, risks for workers' health are still consistently high as
shown in Table 18. There are substantial percentages of workers within each industry (NACE)
who are exposed above OELs proposed under options 2 and 4. This situation calls for timely
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and effective actions at the EU level to ensure that workers' health and safety at work is
safeguarded.
Exposure risks are particularly high in SMEs. Small companies have been found
89
to be at
particular risk of lacking adequate control especially in the manufacture of pigments and dyes,
the formulation of metal treatment products electroplating and wood dyeing. An inspection of
29 chrome planting facilities found that those that used hexavalent chromium were considered
not to be adequately controlling the risks and most were not complying with the relevant
legislation. An EU-wide OEL would then have the positive effect of raising public awareness of
these important occupational health hazards and contribute to better monitoring of exposure
levels and increased compliance of industries.
Table 18. Estimated percentages of workers with exposures exceeding the proposed OEL (Option 2) in high
exposure industries
Some firms within affected industries would require further control measures to meet the
proposed OEL given that estimated geometric standard deviations range from 3.8-14. For
enterprises that would need ventilation systems to comply with an OEL of 0,025 mg/m
3
there
would be a significant up-front capital cost.
90
It is possible that some firms might be able to pass through additional costs in the form of higher
prices for their final products since the OEL would be applied consistently across the EU. This
should create a 'level playing field' for firms across the EU and reduce competitiveness
distortions created by differences on OELs across the EU.
On the macroeconomic side, short term spending on risk management measures may also be
good for the economy as equipment manufacturers (ventilation systems), installers and others
will benefit with money flowing through the economy. With fewer life year lost, there should be
also a benefit to the economy through avoided loss of output and consumption in the future (post
2040). However, since compliance with an OEL would not change the current manufacturing
process there is unlikely to be any significant change to macro-economic impacts.
It should further be noted that the impact of REACH authorisation on relevant chromium (VI)
compounds cannot at this stage be reliably assessed, but should be expected to reduce exposures
and result in reduced costs and benefits associated with setting an OEL for these chemical
agents. When applying for REACH authorisations, enterprises need to also invest in risk
management measures and demonstrate that risks are controlled (either 'adequately' or with
'appropriate and effective risk management measures' according to the case) – potentially
driving investment in additional risk management measures.
A targeted REACH restriction (entry 47 of REACH Annex XVII) applies to placing on the
market or use of (soluble) chromium (VI) compounds as a component of cement, which is
prohibited above a certain concentration. While this restriction is relevant for worker protection,
it should not be expected to significantly affect the overall exposure patterns and associated cost
benefit assessments made in this report. In any case, this restriction was established prior to
REACH (in 2005) and hence its effects have been taken into account in the IOM study.
89
90
Health and Safety Executive (2007) Human Health Risk Reduction Strategy for Chromates
Based on IOM consultants' discussion with suppliers, a ventilation system is estimated to be in the region of
€42k-252k.
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Table 19. Chromium (VI) compounds – Comparison of options
Criteria
Option 1
Baseline
Option 2
0.025 mg/m
3
++
-
+
Option 4
0.05 mg/m
3
+
-
+
Effectiveness
Efficiency
Coherence
Scientific advice
0
0
0
An exposure limit of 0,05 mg/m
3
may well provide adequate protection for
workers exposed to poorly soluble hexavalent chromium compounds but
consideration could be given to setting exposure limits at 0.025 or 0.01
mg/m
3
for other hexavalent chromium compounds.
OEL of 0.025 mg/m
3
.
ACSH
The preferred option is 2 which is more effective reducing exposure and therefore the number of
deaths, while slightly more costly than option 4. In addition, it might trigger more investment in
research and innovation as well as the adoption of products that do not contain chromium.
Option 2 would then be expected to increase the dissemination of improved technologies and
production methods. The potential volume of ventilation systems being required across the EU
may also stimulate investment in R&D to produce more cost-effective systems. Furthermore,
with fewer life years lost and cancer registrations, there should be a benefit to the economy
through avoided loss of output and consumption in the future, for example due to greater
productivity as well as greater consumption and greater taxes raised.
It should be noted that the workers group in the ACSH argued that even a binding limit of 0.025
mg/m
3
would correspond to a high cancer risk. Employers' representatives did not make any
specific comments in the ACSH opinion but the metal industry expressed their positive view on
the establishment of an EU-wide binding OEL as a way to demonstrate appropriate control of
the exposure at the workplace in the course of meetings between Commission services and
industry and workers representatives (see point 9.2.6 in Annex 2).
Impact on Member States and proportionality
In the case of chromium (VI) compounds 21 Member States have no OEL for this agent or have
one that is less protective of worker health than the 0.025 mg/m
3
value recommended by ACSH.
This includes 5 Member States where the national OEL is provided as a range, given that
different OELs apply for different specific Cr(VI) compounds. Figure 15 in Annex 9 illustrates
the ranges of existing national OELs compared to Option 2 the upper limit has been considered
for those countries providing a range of values). The following Figure 16 shows distribution of
exposed workers across the Member States.
Among the six Member States with the highest numbers of exposed, two have no OEL (DE, IT)
Introduction of an EU OEL could ensure that lack of a national OEL or a less stringent OEL
does not act as an incentive for business in decisions concerning the plant location. On the other
hand, the fact that an OEL equal or close to the value proposed by the ACSH is already in place
in one of the Member States with high numbers of exposed workers (FR) as well as in the US
indicates that solutions exist to practically implement the OEL such that businesses are able to
make appropriate investment to protect workers and demonstrate compliance.
It is estimated that approximately 83% of exposed workers are located in Member States with
no OEL for this agent or one that is less protective of worker health. An action at EU level could
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provide a minimum basis of protection against the risks arising from workers' exposure to these
carcinogens for a significant proportion of workers at risk.
5.7
Ethylene oxide (EO)
EO is classified according to the criteria in the CLP Regulation as a category 1B human
carcinogen based on limited human epidemiological evidence and other data that it may cause
leukaemia.
It is used in the manufacture of production of consumer goods such as anti-freeze solvents and
cosmetics. About 3.8 mln tonnes of EO are produced in Europe each year. The majority is used
in the manufacturing of ethylene oxide derivates such as ethylene glycols, which are used in the
production of consumer goods.
It is estimated that approximately 15,600 workers in the EU are potentially exposed and that in
the period 2000-2010 in the EU there were about 5 deaths or less per year from leukaemia that
were attributable to exposure to ethylene oxide before the early 1980s, which corresponded to
about 0.01% of all deaths from leukaemia and a loss of 82 Disability-Adjusted Life Years
(DALYs) each year.
Global market for EO is expected to continue expanding.
91
Table 20. Ethylene oxide (EO) – Types of impacts
Impact
Option 1
Baseline - no OEL
Option 2
OEL of 1 ppm, Sk.
Economic
It is assumed that industries affected have Controls on EO in the workplace needed to
already incurred costs of installing control meet the possible OEL of 1ppm have largely
measures to reduce ethylene oxide
been installed; therefore it is assumed there
emissions.
is not expected to be any significant
additional compliance cost in meeting an
Hospitals may replace EO sterilisation units
OEL of 1ppm relative to the baseline
with non-EO alternatives which are
scenario.
associated with fewer health hazards. The
development of feasible alternatives may
Hospitals may replace EO sterilisation units
benefit research and development in
with non-EO alternatives which are
exposure controls.
associated with fewer health hazards. The
development of feasible alternatives may
benefit research development in exposure
controls.
There is not expected to be any noticeable There are not expected to be any social
social impacts under the baseline scenario. impacts relative to the baseline scenario
from introducing an EU-wide OEL.
Large-scale implementation of control
measures during the 1980s and 1990s
The impacts of introducing an EU-wide
means that exposure is already well below OEL at 1ppm is estimated to have no health
1ppm. Therefore there is not estimated to be benefits as exposure is already estimated to
a cancer risk from worker exposure
be controlled to below 1ppm .
ethylene oxide under current conditions.
None – controls on EO in the workplace
that would be needed to meet the possible
OEL have already been implemented.
Social (incl.
health)
Environmental None – controls on EO in the workplace
needed have already been implemented.
91
See Figure 17 - The Global Ethylene Trade (Annex 9).
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No ethylene oxide exposure data were available from industry. The peer-reviewed scientific
literature for occupational exposure data for the three main uses of EO (i.e. chemical
manufacturing, industrial sterilization, hospital sterilization) shows a baseline scenario that
suggest that EO exposures is generally already below 1 ppm. As a consequence there are not
health benefit are expected since exposure is already estimated to be controlled to below 1ppm
under the baseline scenario.
The economic impact of the baseline scenario highlights that industries affected have already
incurred costs of installing control measures to reduce EO. On the other hand, the economic
benefits could affect mostly research and development due to the introduction of non-EO
alternatives in hospitals.
Other costs and benefits related to 'social', 'macro-economic', and 'environmental' impact of the
baseline scenario are negligible.
Administrative costs of setting the limit of 1 ppm for employers (i.e. minimising exposure of
workers; redesign work processes; hygiene measures; information of workers; training staff;
make information available; consultation with employees; etc.) are estimated to be low since
firms have already been required to carry out these measures following national legislation.
Where there is the possibility of a significant uptake via dermal exposure SCOEL recommend
that any OEL be accompanied by a 'skin notation' (in the case of ethylene oxide ACSH endorsed
this aspect of the SCOEL Recommendation). If adopted and accordingly transposed by Member
States, employers are required under the national transposing legislation to take this into account
in selecting appropriate risk management measures to protect workers.
Once the need for managing exposure has been established the only risk management measure
available in practical terms is to avoid skin contact. Ethylene oxide has a harmonised
classification as a skin irritant (category 2). This hazard would normally result in employers
taking steps to avoid skin contact as a part of routine OSH risk control. Adoption of a 'skin
notation' should therefore result in no additional cost for employers.
Table 21. Ethylene oxide (EO) – Comparison of options
Criteria
Option 1
Baseline
Option 2
1 ppm, Sk.
≈
≈
+
Effectiveness
Efficiency
Coherence
Scientific advice
0
0
0
SCOEL states that at exposures of 1 ppm 'no genotoxic changes could be
directly established in exposed humans so far.'
92
A skin notation is warranted, as clear signs of systemic toxicity were reported
after local application of ethylene oxide.
ACSH
OEL of 1 ppm (= 1.83 mg/m
3
).
The opinion of the social partners and Member States in the ACSH supports option 2, and the
CMD further establishes an expectation that OELs be set where it is possible to do so.
92
Recommendation from the Scientific Committee on Occupational Exposure Limits for ethylene oxide,
SCOEL/SUM/160, June 2012
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Impact on Member States and proportionality
In the case of ethylene oxide nine Member States have no OEL for this agent or have one that is
less protective of worker health than the value recommended by ACSH, so introduction of an
OEL of 1 ppm would represent a significant change in this sense.
The Figure 18 in Annex 9 illustrates the ranges of existing national OELs compared to Option 2.
The following Figure 19 shows distribution of exposed workers across the Member States.
The two Member States where the production and/or use of this chemical agent is concentrated
and the numbers of exposed workers are the highest (DE, UK) have no OEL or OELs above the
limit proposed by the ACSH. Introducing an OEL would bring a greater clarity for economic
operators across the EU and ensure that lack of an OEL or a less stringent OEL does not act as
an incentive for business in decisions concerning the plant location. An OEL of 1 ppm is already
in place e.g. in Australia, Canada, US, Switzerland, New Zealand and Japan.
It is estimated that approximately 43% of exposed workers are located in the nine Member
States with no OEL or an OEL less protective than proposed. Even if current exposure levels in
the EU are estimated to be below 1 ppm, a minimum basis of protection against the risks arising
from workers' exposure to these carcinogens cannot be ensured for all EU workers – it follows
that an action taken at the European Union level to achieve this objective could be justified.
5.8
o-Toluidine
This chemical agent may cause bladder cancer. Occupational exposure is most likely to occur
through inhalation and dermal contact.
o-Toluidine is utilised in the production of dyes and pigments. The industries in Europe that
report the highest workers' exposure levels are: i) Manufacture of chemicals, chemical products
and man-made fibres; ii) Manufacture of rubber products. In the chemical industry exposure to
o-toluidine
can occur during its production and during its use in the production of herbicides,
dyes and pigments, rubber chemicals, epoxy resin hardeners, fungicide intermediates, and
pharmaceutical intermediates. o-Toluidine appears to have been relatively well controlled in
most chemical manufacturing facilities for the past several decades.
The available data indicates that the EU
o-toluidine
production is centred in France, Germany,
Italy, the Netherlands and the United Kingdom
93
. The available information suggests that there
is no
o-toluidine
production in the rest of Europe.
In the EU there are approximately 5,500 workers who are potentially exposed to
o-toluidine.
The prevalence of exposure to
o-toluidine
was estimated from the Finnish CAREX estimates.
The proportion of exposed workers from the Finnish estimate was applied to information on the
number of employees in each industry obtained from the structural business statistics and the
Labour Force Survey available on the Eurostat database. The Finnish proportion of exposed
workers was multiplied by the number of workers in each industry in each other Member State.
Since Finland does not manufacture
o-toluidine,
the estimate of workers' exposure in
manufacturing countries (France, Germany, Italy, the Netherlands and the United Kingdom)
might be underestimated.
It was judged that 98% of workers are exposed to less than 0.1 ppm. In recent years exposure
levels have been decreasing by about 8.8% per annum.
93
IARC 2010
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Table 22.
o-Toluidine
– Types of impacts
Impact
Economic
Option 1
Baseline - no OEL
Option 2
OEL of 0.1 ppm
Option 4
OEL of 1 ppm
Minimal – the vast majority of
investment required to control
exposure associated with the
manufacture of
o-toluidine
has
already occurred in the last 20
years.
There are expected to be costs It is estimated that
to
o-toluidine
related firms to approximately two percent
put into place improved training of exposures are above 0.1
and cleaning measures to reduce ppm. Consequently there
inhalation and dermal exposure are some minimal costs for
that would occur regardless of companies that do not
further intervention over the
currently comply (€0.5-€2K
period 2010-2070.
per company).
The total cost for all
concerned companies of
anticipating investment,
which is assumed to take
place already under the
baseline, is in the range of
€0.2-1.3 mln
Social (incl. health)
The health costs of cancer
Small cost saving (a few
(bladder) over the period 2010 – €k) from avoided health
2070 are estimated to be
care.
€86mln to €696mln
Benefit €1.3mln to
It is assumed that exposures
€10.1mln.
will fall by 8.8% per year in the
future.
Therefore, there is expected to
be some reduction in health
costs going forward in the
absence of further regulatory
intervention.
No change - There are not
expected to be any additional
health costs relative to the
baseline scenario.
There are expected to be
negligible additional health
benefits relative to the baseline
scenario, as exposure is already
expected to be largely / wholly
below 1 ppm.
Environmental
Minimal - Only 2% of workers
exposed to
o-toluidine
are
estimated to be exposed above
0.1 ppm, and therefore most
workplaces are unlikely to
require further changes to their
existing working practice. The
risk of more direct or more
concentrated emissions of
o-
toluidine to the environment
(through ventilation), is
therefore small.
Minimal Cost – it is
Similar to the baseline as
expected that the imposition controls on
o-toluidine
in the
of measures would not
workplace already in place.
cause significant additional
environmental impacts. At
the same time, it is not
expected that the measures
for human health would
lead to any significant
additional environmental
benefit above the baseline
On the basis of estimates of the number of workers exposed and the Eurostat data on the
distribution of firms by size, broad estimates of the number of enterprises requiring further
action to comply with each proposed EU-wide OEL were produced (Table 23-24).
Tables 23-24 show that a total of nine firms are estimated to be affected by an EU-wide OEL at
0.1 ppm while no firms would be affected if an OEL of 1 ppm were to be introduced. It is not
expected that there would be any significant and additional potential closure of companies as a
result of introducing an EU-wide OEL of 0.01 ppm because compliance costs are likely to be
minimal.
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Table 23. Numbers of Enterprises affected in NACE group 25.1
Table 24. Numbers of Enterprises affected in NACE division 23
The industrial sector estimated to benefit most from the introduction of an EU-wide OEL is the
manufacture of chemicals. The administrative costs for employers are estimated to be low in
both baseline scenario and in the intervention scenario of OEL 1 ppm, since most of the
investments needed to decrease the exposure have already been made. Low to medium costs
would involve firms that do not currently comply with baseline scenario in case an OEL of 0.1
ppm was going to be implemented.
Table 25.
o-Toluidine
– Comparison of options
Criteria
Option 1
Baseline
Option 2
0. 1 ppm
+
≈
Option 4
1 ppm
≈
+
+
Effectiveness
Efficiency
Coherence
Scientific advice
ACSH
0
0
0
+
IOM Study considered potential OELs of 0.1 ppm (0.4 mg/m
3
) and 1 ppm
(4.4 mg/m
3
) as 'typical' values of existing national OELs in the EU.
Proposes an OEL of 0.1 ppm
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Neither option is predicted to give rise to any important reduction in bladder cancer death or
registrations over the baseline assumptions, primarily because exposures are already very low.
However, the preferred option is 2 as it brings some health benefits while generating only
slightly higher costs than option 4. Industry is almost fully compliant with this OEL already and
0.1 ppm has been accepted by all parties in the ACSH discussions. Switzerland and New
Zealand have set lower OELs for this chemical agent.
Impact on Member States and proportionality
In the case of
o-Toluidine
25 Member States have no OEL for this agent or have one that is less
protective of worker health than the value recommended by ACSH. The Figure 20 in Annex 9
illustrates the ranges of existing national OELs compared to Option 2. The following Figure 21
shows distribution of exposed workers across the Member States.
Thus, introduction of an OEL of 0.1 ppm would represent a significant change in this sense. It is
estimated that approximately 98% of exposed workers are located in those 25 Member States.
Even if current exposure levels in the EU are estimated to be largely below 0.1 ppm, a minimum
basis of protection against the risks arising from workers' exposure to these carcinogens cannot
be ensured for all EU workers under the baseline scenario – it follows that an action taken at the
European Union level to achieve this objective could be justified.
5.9
Refractory Ceramic Fibres (RCF)
Occupational exposure to RCFs is associated with adverse respiratory effects as well as skin and
eye irritation and may pose a carcinogenic risk based on the results of chronic animal inhalation
studies. However, epidemiologic studies have found no association between occupational
exposure to airborne RCFs and an excess rate of pulmonary fibrosis or lung cancer. Based on
the animal test results, certain RCFs are classified according to the CLP Regulation as Carc. 1B
(may cause cancer by inhalation).
RCFs are synthetic vitreous fibres or man-made mineral fibres used in industry for their
properties of heat resistance, tensile strength and durability. The total tonnage of RCF used in
the EU is about 25,000 tonnes per year, 90% of which is used for industrial insulation. Ceramic
fibres are typically used only in industrial settings, implying no consumer exposure.
For the estimations, due to unavailability of epidemiological data, exposure to RCFs has been
assumed to be no worse than exposure to chrysotile (white) asbestos in terms of cancer risk.
On the basis on information provided by the European Ceramic Fibre Industry Association, it is
estimated that about 10,000 workers are exposed to RCF across the EU. Of these, about 730 are
employed in RCF production plants in Germany, France and the UK, and about 9,270 in the
downstream user industry (a breakdown by Member State not available. Geometric mean
exposures in the industry are less than 0.2 fibres/ml and it is estimated that about 7% of workers
in manufacturing facilities and 12% of workers at downstream user facilities have been exposed
above 1 fibres/ml. More than half of workers are exposed above 0.1 fibres/ml. A majority of the
companies in question (downstream use) are SMEs.
It should be noted that, in December 2011, certain RCFs were identified as 'substances of very
high concern' under REACH owing to classification under CLP as a category 1B carcinogen.
This constitutes the initial step toward possible inclusion into REACH Annex XIV and hence
REACH 'authorisation'. In February 2014 the European Chemicals Agency further
recommended to the European Commission that RCF, among other chemical substances, be
included into REACH Annex XIV.
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Two possible substitutes for RCF are Alkaline-Earth Silicate Glass Wool (AES), which however
is an imperfect substitute (having a lower applicable temperature range for thermal insulation),
and Polycrystalline Wool (PCW), which however is 20 times more expensive than RCF.
Table 26. Refractory Ceramic Fibres (RCF) – Types of impacts
Impact
Economic
Option 1:
Baseline: No OEL
A 7% annual decline
in average exposure
is assumed until
2030.
Option 2:
OEL of 0.3 f/ml
The total cost for of
anticipating investment,
which is assumed to
take place already under
the baseline, is in the
range of EUR 1-6 mln.
Substitution with
alternatives would not
occur.
Option 3:
OEL of 0.1 f/ml
To achieve exposure at
this level would require a
degree of automation and
enclosure that is deemed
not to be feasible for
certain downstream uses.
Estimated total additional
costs is in the range of
EUR 60-139mln.
If achieving the OEL is
technically or
economically infeasible,
companies may decide to
substitute RCF with
alternatives. In such case,
the associated total costs
could be of the order of
EUR 2.5 bln.
It is possible that such an
OEL could lead to firms
relocating production
processes outside of the
EU.
Option 4:
OEL of 1 f/ml
No additional
significant costs for
firms vs. the
baseline are
expected, as
average exposure is
already below 1
fibres/ml.
Social (incl. health)
Total attributable
deaths for 2010-
2069: 50. Total
YLLs: 830. Total
DALYs: 860.
The total cancer-
related health costs Net cancer-related
over a 60-year period health benefits are
are estimated to be in estimated to be in the
the range of EUR 33- range of EUR 1.1-
83mln.
3.4mln.
Total attributable deaths
for 2010-2069: 0. Total
YLLs: 790 (40 less than
the baseline). Total
DALYs: 800 (50 less
than the baseline).
Total attributable
deaths for 2010-
2069: 0. Total
YLLs: 790 (40 less
than the baseline).
Total DALYs: 810
(40 less than the
Net cancer-related health
baseline).
benefits are estimated to
be in the range of EUR
Net cancer-related
1.2-3.4mln.
health benefits are
estimated to be in
the range of EUR
1.1-3mln.
The use of AES and PCW None.
as substitutes for RCF as
a furnace insulation has
environmental costs
including worsened
energy efficiency.
Total attributable deaths
for 2010-2069: 0. Total
YLLs: 790 (40 less than
the baseline). Total
DALYs: 800 (50 less
than the baseline).
Environmental
None.
None.
The values of health benefits are relatively low for all the options because of the low level of
assumed cancer incidence under the baseline and the existing controls in place.
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Option 3 would be the most effective option in reducing occupational exposure to carcinogens
and levelling the playing field across the Union. However, it raises significant problems of
technical feasibility (the OEL may de facto not be achievable in some instances) and imposes
therefore excessive burden on firms even if some of the costs associated with substitution of
RCF with more expensive alternatives (such as PCW) would be passed through to consumers
via higher prices. Option 2 appears to be more efficient. It leads to a similar reduction of Years
of Life Lost and Disability Adjusted Life Years as Option 3, but at a significantly lower cost.
Table 27. Refractory Ceramic Fibres (RCF) – Comparison of options
Criteria
Option 1
Baseline: No
OEL
Option 2:
0.3 f/ml
++
-
+
Option 3:
0.1 f/ml
++
--
+
Option 4:
1 f/ml
+
≈
+
Effectiveness
Efficiency
Coherence
Scientific
advice
(SCOEL)
ACSH
0
0
0
RCF is considered as a genotoxic carcinogen for which a practical threshold is
supported. An OEL of 0.3 f/ml is proposed.
Agrees that an OEL is necessary but could not reach agreement on exact value
(between 0.3 f/ml and 0.1 f/ml).
Option 2 because is the most effective and corresponds to the limit recommended by SCOEL.
Some MS have already imposed nationally a similar OEL, and there are no concerns regarding
technical feasibility. In addition, this is the minimum common denominator of ACSH
discussions. Employers advise to follow the recommendation of SCOEL. They also stress that
industries have been working on a 0.5 f/ml exposure limit for many years, and further reductions
of exposure are technically difficult. Views of Member States range from 0.3 f/ml to 0.1 f/ml.
The workers argue for an OEL 0.1f/ml on the basis of considerations detailed in the scientific
explanations given for the exposure risk relationship on aluminosilicate fibres derived in
Germany, according to which aluminosilicate fibres exhibit a carcinogenic potency comparable
to asbestos.
94
Impact on Member States and proportionality
In the case of RCF, 24 Member States have no OEL for this agent or have one that is less
stringent than 0.3 f/ml. Figure 22 in Annex 9 illustrates the ranges of existing national OELs
compared to Option 2. There is insufficient data to provide a breakdown by Member State.
RCF is only manufactured in three MS (FR, UK, DE) but exposure from use and disposal (e.g.
from insulation in furnaces) may be located across Europe. Thus, introduction of an OEL of 0.3
f/ml would require changes for a substantial number of MS. The analysis shows that a minimum
basis of protection against the risks arising from workers' exposure to these carcinogens cannot
be ensured for all EU workers under the baseline scenario – it follows that an action taken at the
European Union level to achieve this objective could be justified.
5.10 Respirable Crystalline Silica
RCS is taken here to mean 'the respirable fraction of crystalline silica dust generated by a work
process'. RCS, so-defined, is a process generated substance which is not placed on the market
94
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and, as such, is not classified under the CLP Regulation. This is the reason why it is proposed to
be included in Annex I of the CMD. In addition, a few options for an OEL value to be included
in the Annex III are considered.
IARC has stated its opinion that 'crystalline silica inhaled in the form of quartz or cristobalite
from occupational sources is carcinogenic to humans (Group 1)'.
95
Crystalline silica is abundant in rocks, sands and soils. Exposure to RCS therefore occurs in
many industries. Common exposure scenarios include earth moving (eg. mining, quarrying,
tunnelling), crushing or grinding of silica-containing material such as concrete, aggregate or
mortar, the manufacture of glass and other non-metallic mineral products and the use of sand as
moulding media in foundries.
It is estimated that 5,300,000 EU workers are potentially exposed, more than 70% of them in the
construction sector. Beside construction, the following industries are estimated to have the
highest exposure levels compared to the other industry sectors as well as the highest numbers of
exposed workers: manufacture of other non-metallic mineral products, other mining and
quarrying, manufacture of basic metals, manufacture of fabricated metal products, electricity,
gas, steam and hot water supply.
Table 28. Respirable Crystalline Silica – Types of impacts
Impact Option 1:
Baseline - not
under Annex I, no
OEL
Economic
It is assumed that
exposures fall by
7% per year
Therefore firms
will already be
incurring costs for
exposure control
measures even
without EU
intervention.
There are not
expected to be any
noticeable
macroeconomic
impacts.
Option 2:
Inclusion in Annex
I and OEL at 0,1
mg/m
3
in Annex III
Investment is
expected to occur
already under the
baseline, only
possibly later in
time: the costs of
anticipating this
expenditure by 10-20
years would be
around €3.5 bln.
The greatest costs are
predicted to fall on
the construction
sector given the
number of
enterprises thought
to be affected
(around 370,000).An
impact on SMEs is
Option 3:
Inclusion in
Annex I and OEL
at 0,05 mg/m
3
in
Annex III
Investment is
expected to occur
already under the
baseline, only
possibly later in
time: the costs of
anticipating this
expenditure by 10-
20 years would be
around €15.7 bln.
The greatest costs
are predicted to
fall on the
construction sector
given the number
of enterprises
thought to be
affected (around
485,000).A
Option 4:
Inclusion in Annex I
and OEL at 0,2 mg/m
3
in Annex III
Investment is expected
to occur already under
the baseline, only
possibly later in time:
the costs of anticipating
this expenditure by 10-
20 years would be
around €207 mln.
The greatest costs are
predicted to fall on the
construction sector given
the number of
enterprises thought to be
affected (around
250,000).The
impact on
companies and
particularly on SMEs is
weaker as costs of
compliance would be
95
http://monographs.iarc.fr/ENG/Monographs/vol68/mono68-6.pdf In making its overall evaluation the IARC
Working Group noted that carcinogenicity in humans was not detected in all industrial circumstances studied,
and that carcinogenicity may be dependent on inherent characteristics of the crystalline silica, or on external
factors affecting its biological activity or distribution of its polymorphs. It should be noted that the common
silica 'polymorphs' (i.e. different forms of crystallised silica) quartz, cristobalite and tridymite have all been
classified according to the CLP Regulation by suppliers. Some suppliers have classified quartz and crystobalite
as carcinogenic category 1. Tridymite has not been so classified. No harmonised (mandatory) classification has
been proposed.
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Impact Option 1:
Baseline - not
under Annex I, no
OEL
Option 2:
Inclusion in Annex
I and OEL at 0,1
mg/m
3
in Annex III
foreseen, with a risk
of closures or
relocations outside
the EU. This is due
to high costs linked
with the installation
of exposure control
measures.
There will be some
short terms benefits
(for ventilation and
respiratory protective
equipment
manufacturers).
Option 3:
Inclusion in
Annex I and OEL
at 0,05 mg/m
3
in
Annex III
significant impact
on SMEs is
foreseen, with a
high risk of
closures or
relocations outside
the EU. This is due
to high costs
linked with the
installation of
exposure control
measures.
There might be
some short terms
benefits
(ventilation and
respiratory
protective
equipment
manufacturers).
However
compliance costs
might be passed on
to consumers
(higher prices).
Total attributable
deaths for 2010-
2069: 332.650, i.e.
107.350 less than
under baseline.
Net health benefits
are estimated to
range between
€36.5 and 97.1 bln.
Option 4:
Inclusion in Annex I
and OEL at 0,2 mg/m
3
in Annex III
lower.
Social
Total attributable
deaths for 2010-
2069: 440 000
deaths.
There is also
expected to be
some reduction in
health costs. The
health costs of
cancer (lung) over
the period 2010- 70
are estimated to be
€192-493bln.There
is estimated to be a
greater number of
firms installing and
using closed
systems and using
RPE, PPE and wet
cleaning rather than
dry cleaning.
These should not
affect the skills
required by
Total attributable
deaths for 2010-
2069: 341.330, i.e.
98.670 less than
under baseline.
Net health benefits
are estimated to
range between €34
and 89 bln.
Total attributable deaths
for 2010-2069: 357.620,
i.e. 82.380 less than
under baseline.
Net health benefits are
estimated to range
between €27.7 and 73.7
bln.
As the risks of closure
The introduction of
The introduction of are expected to be
the OEL may affect
the OEL may
smaller – and even
job patterns and
affect job patterns
minimal if financial
would necessitate
and would
assistance schemes are
new health and
necessitate new
made available for
safety training. The
health and safety
SMEs – there is not
potential closing
training. The
significant impact on
down or relocation of potential closing
employment.
companies would
down or relocation
have a negative
of companies
impact on
would have a
employment;
negative impact on
however, the
employment;
reduction of
however, the
exposure would
reduction of
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Impact Option 1:
Baseline - not
under Annex I, no
OEL
workers and
training costs are
expected to be
small.
Since the control
measures such as
closed system
reduce risks of
human exposure in
a way that should
not inhibit
production, there
should also be
improvements in
working conditions.
The use of wet
cleaning and RPE
should also reduce
risks of human
exposure, although
their use may
potentially slow
down operations or
be perceived to do
so.
Environmental
Very little
information is
available regarding
the ecotoxicitiy of
RCS. No
significant
environmental
effects are expected
due to the chemical
inertness and slow
solubility of the
chemical agent.
Crystalline silica is
resistant to
decomposition by
weathering,
biological activity
and further
oxidation.
Option 2:
Inclusion in Annex
I and OEL at 0,1
mg/m
3
in Annex III
improve working
conditions.
Option 3:
Inclusion in
Annex I and OEL
at 0,05 mg/m
3
in
Annex III
exposure would
improve working
conditions. The
OEL could require
workers to be
constantly wearing
respiratory
protective
equipment as
levels of exposure
will be close to the
natural background
level of RCS in air.
Option 4:
Inclusion in Annex I
and OEL at 0,2 mg/m
3
in Annex III
No major
environmental
impact is foreseen.
There might some
impact due to
increased emission
of RCS to the
environment, and
additional demand
for electricity due to
ventilation systems.
The same as in
Option 2.
The same as in Option 2.
As in the case of all other considered chemical agents, the exposure trends for RCS used to
establish the baseline are quoted from the IOM study. The validity of these assumptions is
discussed in the introduction to section 5. Specifically for silica the correctness of the assumed
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7% decline can be further questioned based on the fact that among the three studies that IOM
used to build this assumption, two are only looking at quarries. The only one that analyses all
industries comes from the US. Lack of data for the two principal exposure sectors
("construction" and the "electricity, gas, steam and hot water supply") weakens the assumption
of exposure decline.
A different exposure trend can be derived for example from a Finnish study (Kauppinen et al.,
2013)
96
, which looked at data from FINJEM database, starting in 1950 and projected trends till
2020. This study found that an overall exposure decline was 1% rather than 8%. The data
presented in this study shows also that exposures were declining significantly faster between
1950 and 1990, compared to more recent years.
97
Even with the IOM studies estimates, a high proportion of workers are considered to still be at
risk of being exposed above the considered OELs (14% above 0.2 mg/m
3
, 26% above 0.1
mg/m
3
, 41% above 0.05 mg/m
3
), and the estimated mean exposure is 0.07 mg/m
3
.
The prevalence of exposure to RCS in the IOM report was estimated from a Finnish, a Spanish
and an Italian study. The proportion of exposed workers in each industry was taken from each of
these three studies and the average proportion exposed across all three countries was found for
each industry. The average proportion of exposed workers was applied to information on the
number of employees in each industry obtained from the structural business statistics and the
Labour Force Survey available on the Eurostat database. The average proportion of exposed
workers was multiplied by the number of workers employed in each industry in each country in
2006 to estimate the number of exposed workers in each industry and country.
However there is a limited availability of exposure data, and it is not possible to determine
exposure differences across the EU. Moreover, exposure levels and therefore cancer risk vary
greatly according to the sectors.
According to the IOM report, the countries with the highest numbers of exposed workers are
Spain (26.8% of all EU workers), Germany (11.8%), France (11%) and the UK (9.4%).
In all industries with high prevalence of RCS exposure, the majority (between 58 and 94%
depending on the industry) of companies are very small, with 1 to 9 employees. The industrial
minerals industry alone consists mainly of SMEs with some large multinational companies.
Members of the Industrial Minerals Association operate over 810 sites throughout Europe.
The IOM report recognises that the number of workers and enterprises affected by the proposed
reduction in the OEL are likely to be an overestimate since the NACE codes include activities in
which workers may not necessarily be exposed to RCS.
In all the considered options, introducing an OEL for RCS will contribute to reducing
attributable deaths compared to no action, and the benefits of introducing an OEL may outweigh
compliance costs. Moreover, any reduction of exposure will also lower the risk of silicosis.
Indeed exposure to respirable crystalline silica in workplace air is associated with the
development of silicosis, an irreversible scarring disease of the lung. Silicosis also appears to be
a significant risk factor for the development of lung cancer. As the health costs of silicosis were
not taken into account in the IOM report, the total health benefits of introducing an OEL are
clearly higher than was has been indicated for the purposes of this proposal.
While the compliance costs are relatively high for all three options, they should be compared to
the total value of goods and services in the affected sectors, which was €5 trillion in 2006.
96
Exposure to carcinogens and work-related cancer: a review of assessment methods, EU-OSHA 2014, Available
at https://osha.europa.eu/en/tools-and-publications/publications/reports/report-soar-work-related-cancer/view
See Figure 23 - Occupational inhalation exposure to crystalline silica (quartz dust) in Finland in 1950, 1970,
1990 and 2008 and predicted for 2020, as measured by four different metrics of exposure (Annex 9).
67
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Moreover, the bulk of compliance costs will be already incurred under the baseline scenario (i.e.
in the absence of EU action). Imposing an EU OEL would however oblige businesses to
anticipate the corresponding investments.
It should also be added that the options have variable impacts on different sectors. For example,
for quarrying, costs are significantly lower under option 4 compared to both 2 and 3. For some
other sectors, such as foundry, brick manufacture or silica sand production options 2 and 4 result
in the same costs. As for the construction sector, which represents a majority of the affected
firms, average cost per enterprise is the same under all three options.
Option 3 would be the most effective in reducing occupational exposure to carcinogens but will
have a negative impact on some sectors of the industry
98
, and in particular on SMEs. Option 2
has similar characteristics, however its impact should be lower on the industry.
99
At least 17
countries are reported to have already introduced an OEL of 0,1 mg/m
3
or below.
100
A majority
of EU countries are therefore already compliant with Option 2, which indicates that the impact
of introducing Option 2 would be lower than Option 3. Option 4 would imply the lowest
compliance costs and the least negative impact on SMEs, however it would be less effective in
reducing cancer. Moreover, the OEL of 0,2 mg/m
3
would be higher than the majority of national
OELs already in place. No significant environmental impact is foreseen in none of the options.
Some stakeholders argue that the Carcinogens Directive is not the appropriate legal framework
to introduce OELs for RCS – instead, they argue for introduction of an EU OEL via the
Chemical Agents Directive as the most efficient risk management tool.
A mechanism exists to establish EU OELs via the Chemical Agents Directive – these may be
either 'binding' (mandatory maximum) or 'indicative' (indicated maximum) in nature, with
Member States committed, as a minimum requirement, to in any case ensure that national OELs
are established for the chemical agents in question, taking into account the values set at EU
level.
However, RCS is a long- and widely-recognised occupational carcinogen – including long-
standing classification by IARC. A clear threshold for silicosis development cannot be
identified, and there is sufficient information to conclude that preventing the onset of silicosis
will also reduce the cancer risk.
101
It is therefore most appropriate to establish an EU OEL
under CMD for this chemical agent where it is either generated as a result of a work process or
otherwise classified as a category 1 carcinogen according to the CLP criteria.
Stakeholders also put forward existing guidelines and good practices. Most notably, as reported
above, NEPSi requires signatories to follow good practices and monitoring protocol, and to
provide quantitative data.
98
Compared to option 4, option 3 creates higher costs per enterprise in the following sectors: quarry, foundry,
ceramics, brick manufacture, silica sand production, scouring powders, stonemasonry.
Compared to option 4, option 2 creates higher costs per enterprise in only three sectors: quarry, ceramics,
stonemasonry.
BE, BG, CZ, DK, EE, ES, FI, FR, HR, IE, LT, MT, NL, RO, SE, SK, UK
Further information on the carcinogenity of silica can be found in Annex 12. The current SCOEL
recommendation refers IARC Monograph 68. More recent information on the carcinogenicity of RCS in the
IARC monograph volume 100C on arsenic, metals, fibres and dusts, which is likely to be taken into account in a
future revised SCOEL recommendation, further confirms the carcinogenity of RCS based on newer scientific
evidence.
68
99
100
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Table 29. Respirable Crystalline Silica (RCS) – Comparison of options
Criteria
Option 1:
Baseline - not
under Annex I,
no OEL
Option 2:
Inclusion in
Annex I and
OEL at 0,1
mg/m
3
+
+
++
Option 3:
Inclusion in
Annex I and
OEL at 0,05
mg/m
3
++
-
+
Option 4:
Inclusion in
Annex I and OEL
at 0,2 mg/m
3
-
++
-
Effectiveness
Efficiency
Coherence
Scientific advice
(SCOEL)
ACSH
0
0
0
An OEL should lie below 0.05 mg/m3 of respirable silica dust
ACSH: A binding OEL at 0.1 mg/m3, measured as respirable dust, is
justified. The value should be reviewed within 3-5 years.
Option 2 (0,1 mg/m
3
) is a feasible option for EU industries, while still guaranteeing a substantial
reduction of estimated attributable deaths due to lung cancer. Introducing an OEL of 0.05 mg/m
3
would increase the estimated health benefits by around 10%, but would also increase the
estimated compliance costs by close to 80%. It is therefore considered that the cost/benefit ratio
of introducing an OEL 0,1 mg/m
3
is better than introducing an OEL of 0.05 mg/m
3
.
It is also the level agreed by the ACSH even if there were some questions on the part of
employers and some MS whether it would not be more appropriate to legislate under the CAD.
Workers stated that further exposure reduction below the proposed binding OEL of 0.1 mg/m³ is
paramount to reduce the risks of lung cancer, and silicosis.
According to the IOM report there is a risk that production would be affected as a result of the
need to comply with more stringent OELs and with high compliance costs. Indeed, the majority
of the companies that would be affected by the imposition of an OEL are SMEs and the costs
may be very expensive for a large proportion of the affected sectors. If the costs cannot be
passed through to consumer prices and/or some companies will not be able to get access to loans
to pay for the necessary investment, there is a possibility of some company closures and, for
industries for which it is possible, some relocation of activities in non-EU countries. Such
impacts may be differentiated at the sector and sub-sector level, by geographical location, and/or
at operator level.
Among the six Member States with the highest numbers of exposed workers (see Figure 25 in
Annex 9), two have no OEL (DE, IT) and one has an OEL significantly less protective than 0.1
mg/m
3
(PL) thus there is a case of competitive advantage compared to Member States which
have adopted more stringent measures. On the other hand, the fact that an OEL equal or below
the value proposed by the ACSH is already in place in the other three Member States with high
numbers of exposed workers (ES, FR, UK) and in 14 other Member States indicates that
solutions exist to practically implement the OEL.
It should also be noted that an OEL at 0,1 mg/m
3
is comparable or higher to the levels applied in
most non-EU countries (except notably China). For the USA, a new value of 0,05 mg/m
3
is
being proposed for RCS
102
. The proposed revision of the existing value is based on evidence
that indicates employees exposed to RCS well below the current value of 0,1 mg/m
3
are at
increased risk of lung cancer mortality and silicosis mortality and morbidity. At the same time,
it is assumed that an OEL of 0.05 mg/m
3
would be technologically feasible for most affected
102
Federal Register
/ Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
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industries, except two out of 12 construction activities, and would not have any major micro-
and macro-economic impact.
Finally, the reluctance on the part of employers to accept that RCS is regulated under the CMD
appears to be related to concern regarding the stricter standard for substitution and exposure
control (process enclosure) resulting from application of the CMD over CAD. There is also
some concern regarding stigmatisation of silica as a carcinogen and associated negative impacts
on industry, for instance in case of 'social license'
103
to operate mines and quarries. It should
however be noted that some forms of RCS have been classified as carcinogenic by the IARC
since 1987. Potentially, compliance with an OEL provides an opportunity for industry to
demonstrate to workers and others that the necessary measures to address the risks of handling
this chemical agent are in place.
Impact on Member States and proportionality
In the case of RCS, 11 Member States have no OEL or have one that is less stringent than the
ACSH recommended 0.1 mg/m
3
level. Figure 24 in the annex 9 illustrates the ranges of existing
national OELs compared to Option 2. Figure 25 shows distribution of exposed workers across
the Member States.
33% of exposed workers are estimated to work in those 11 MS. Under such circumstances a
minimum basis of protection against the risks arising from workers' exposure to these
carcinogens cannot be ensured for all EU workers under the baseline scenario – it follows that
an action taken at the European Union level to achieve this objective would be justified.
5.11 Vinyl Chloride Monomer (VCM)
Exposure to VCM is associated with increased risks of the usually rare form of liver cancer,
angiosarcoma, and possible increased risks of hepatocellular carcinomas. VCM is classified as a
Group 1 carcinogen by IARC, and as Cat 1 carcinogen in the EU under the classification and
labelling legislation. An OEL of 3 ppm is currently in place at EU level.
95% of VCM
104
produced worldwide is used in the manufacture of Polyvinyl Chloride (PVC)
and its associated polymers. The latter is then used to manufacture automotive parts and
accessories, furniture, packaging materials, pipes, wall coverings, and wire coatings. VCM
production is often located on the same site as the production of PVC. In 2007, 7.2 mln tons of
VCM were produced in the EU and Norway in 30-40 plants located in 13 EU Member States
105
and Norway. In total, there are approximately 100 VCM manufacturing or polymerisation sites.
There are no substitutes to VCM for VCM production.
In the EU, about 15,000 workers from VCM and PVC plants are estimated to be potentially
subject to high exposure levels. No breakdown by Member State is available. Exposure to VCM
outside VCM and PVC manufacturing industry is limited, with about 5 000 more workers (in
manufacture of rubber and plastic products, water transport, supporting and auxiliary transport
activity, R&D) potentially subject to (negligible) background exposure.
The risk estimates used in the IOM study for the assessment of health impacts are based on
evidence provided by the existing epidemiologic literature. The estimates on current exposure
103
104
The 'social license' concept describes ongoing approval within a local community or broad social acceptance.
It should be noted that a targeted REACH restriction applies to placing on the market or use vinyl chloride
(although not specified in monomer form) for use as an aerosol propellant, which is prohibited. This restriction
is not relevant for worker protection, and it should not be expected to affect the exposure patterns and associated
cost benefit assessments made in this report.
Belgium, Czech Republic, Germany, Spain, France, Italy, Hungary, the Netherlands, Poland, Romania, Slovakia,
Sweden and the UK.
70
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levels used are derived from the existing scientific literature
106
, and from exposure data
collected in 2008 from 36 VCM and PVC plants (a non-random sample of the around 100 plants
present in the EU). No detailed information is available on differences in exposure levels across
Member States.
Table 30. Vinyl Chloride Monomer (VCM) – Types of impacts
Impact
Option 1
Baseline: OEL at 3
ppm
Option 2:
OEL of 1 ppm
A large majority of firms already
control exposure below 1 ppm.
Currently, 25% of the plants are
estimated to have 90
th
percentile
exposure above 1ppm. The costs
of upgrading equipment to meet
the 1ppm exposure limit could be
up to €2.5mln per VCM/PVC
production site.
The concerned plants would be
located mainly in Czech Republic,
Romania, Slovakia, Hungary and
Poland.
Investment is expected to occur
already under the baseline, only
possibly later in time: the
additional costs of anticipating
this expenditure by 10 years –
2010 vs 2020 would be in the
range of EUR 4-8 mln (€2-3mln if
no additional shutdowns).
Total attributable deaths for 2010-
2069: 300. Total YLLs: 4,220 (50
less than the baseline). Total
DALYs: 4,300 (50 less than the
baseline).
Net health benefits compared to
the baseline are estimated to be
between € 1-4 mln.
Option 4:
OEL of 2 ppm
A very large majority of
firms already control
exposure below 2 ppm.
Currently, only 6% of the
plants are estimated to have
90
th
percentile exposure
above 2ppm. The costs of
upgrading equipment to meet
the 2ppm exposure limit
could be up to €0.25mln per
VCM/PVC production site.
Investment is expected to
occur already under the
baseline, only possibly later
in time: the additional costs
of anticipating this
expenditure by 10 years –
2010 vs 2020 would be
below € 1 mln.
Economic
All firms are deemed
to be compliant with
the current EU OEL
of 3ppm, with most
VCM and PVC
plants in the EU
currently controlling
VCM exposure well
below such level. It
is estimated that
under the baseline
scenario firms are
already moving
towards complying
with the 1 ppm OEL.
Social
Total attributable
deaths for 2010-
2069: 300. Total
YLLs: 4,270. Total
DALYs: 4,350.
The total cancer-
related health costs
over a 60-year period
are estimated to be in
the range of EUR
194-472mln.
Total attributable deaths for
2010-2069: 300. Total YLLs:
4,250 (20 less than the
baseline). Total DALYs:
4,330 (20 less than the
baseline).
Net health benefits are
estimated to be €1-2mln.
Environm
ental
None.
None.
None.
Option 2 would be the most effective option in reducing occupational exposure to carcinogens
and levelling the playing field across the EU. It also leads to the highest reduction of Years of
Life Lost and Disability Adjusted Life Years. Already under the baseline the majority of
companies is able to control exposure under the 1ppm exposure level, but option 2 would imply
106
A summary of results of VCM exposure studies in the EU is reported in the IARC monograph on vinyl chloride,
vol. 97, 2008.
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that those enterprises who are not currently below that level would no longer be able to delay
investment to introduce preventative measures and effectively minimise exposure. There is a
ready market for VCM and no plant closures are expected to result from the implementation of a
more stringent OEL.
Table 31. Vinyl Chloride Monomer (VCM) – Comparison of options
Criteria
Option 1:
Baseline: OEL at
3 ppm
Option 2: OEL at 1
ppm
Option 4: OEL at 2 ppm
Effectiveness
Efficiency
Coherence
Scientific advice
(SCOEL)
ACSH
0
0
0
++
≈/-
+
+
≈
+
A continuous exposure for working life to 1ppm vinyl chloride would be
associated with a cancer risk for hepatic angiosarcoma of about 0.3 x 10
-3
.
Agreed limit = 1 ppm.
Option 2 is the most effective and the closest to the limit recommended by SCOEL. In addition,
this is the level that has been agreed at ACSH discussions. Some MS have already imposed
nationally a similar OEL, and there are no concerns regarding technical feasibility. The same
OEL is already in place in the US and Canada.
Impact on Member States and proportionality
In the case of VCM, 25 Member States have so far opted to set a limit which is less protective of
worker health than the ACSH recommended 1 ppm. Figure 26 in the annex 9 illustrates the
ranges of existing national OELs compared to Option 2.
There is insufficient data to provide a breakdown by Member State. However, given the number
of Member States with higher OELs, a minimum basis of protection against the risks arising
from workers' exposure to these carcinogens cannot be ensured for all EU workers under the
baseline scenario – it follows that an action taken at the European Union level to achieve this
objective could be justified.
5.12 Bromoethylene (vinyl bromide)
Bromoethylene may cause liver cancer.
Bromoethylene is used as a flame retardant in the production of acrylic fibres carpet backing
materials. Other uses include children’s sleepwear and home furnishings.
Number of people exposed in the EU likely to be small, i.e. less than a few hundred, but there is
not enough information to assess the actual extent of exposure. Given the uncertainty about the
number of exposed workers it is not possible to provide a health impact assessment. Similarly,
there are no estimates of health costs of inaction for this chemical agent.
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Table 32. Bromoethylene (vinyl bromide) – Types of impacts
Impact Option 1
Baseline - no OEL
Economic
Option 2
OEL of 1 ppm
Option 4
OEL of 5 ppm
It is assumed that exposures (no data)
It is estimated that, under the
fall by 7% per year in the Based on the available baseline scenario, firms are
future.
measurements and the annual already achieving exposures
Therefore, there are expected reduction in exposure the less than 5 ppm.
to be some costs to firms consultant
judged
that Therefore there are not
where
bromoethylene occupational exposure levels expected to be any significant
exposure occurs to put into are currently low, with the additional costs of meeting an
place
employee
training, highest exposures probably OEL of 5 ppm relative to the
Personal protective equipment about 3 mg/m
3
(less than 1 baseline scenario.
(PPE)
and
ventilation ppm).
measures to reduce inhalation
and dermal exposure that
would regardless of further
interventions over the period
2010 – 2069
There are not expected to be
There are not expected to be
any noticeable social impacts
any noticeable change to the
under the baseline scenario at
number of workers required as
an EU level.
a result of introducing an EU-
wide OEL.
There is insufficient
information to calculate the
No health costs and no health
health impacts expected under
benefits are expected.
the baseline.
There are not expected to be
any noticeable environmental
impacts under the baseline
scenario at an EU level.
No workers exposed to
bromoethylene are estimated
to be exposed above the
possible EU-wide OEL of 5
ppm, and therefore most
workplaces are unlikely to be
affected / require further
changes to their existing
working practice. Therefore
there are not estimated to be
any significant changes in
environmental impacts.
Based on the available measurements and the annual reduction in exposure the consultant
judged that occupational exposure levels to bromoethylene are currently low, with the highest
exposures probably about 3 mg/m
3
(less than 1 ppm).
There are no predicted health benefits from setting an OEL at 5 ppm, although it can be assumed
that the impact would be relatively small because current exposures are estimated to be much
lower than 5 ppm. There are no additional costs associated with compliance with an OEL of 5
ppm. There are also no social or macro-economic costs associated with introducing such an
OEL. There are no significant environmental impacts foreseen. Lack of data for option 2 does
not allow assessing its impacts.
Environmental
Social (incl. health)
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Table 33. Bromoethylene (vinyl bromide) – Comparison of options
Criteria
Option 1
Baseline
Option 2
1 ppm
(++)
(+)
(++)
Option 4
5 ppm
≈
≈
+
Effectiveness
Efficiency
Coherence
Scientific
advice
(SCOEL)
ACSH
0
0
0
SCOEL recommends to use the existing quantitative risk assessment for vinyl
chloride (SCOEL/SUM/109) also for vinyl bromide (bromoethylene), considering a
three times higher potency of vinyl bromide compared to vinyl chloride.
OEL of 1 ppm is proposed following the SCOEL recommendation for vinyl chloride,
the carcinogenic effects of which are similar to vinyl bromide.
The opinion of the social partners and Member States in the ACSH supports option 2, and the
CMD further establishes an expectation that OELs be set where it is possible to do so.
Introducing an OEL would also be effective in introducing a greater clarity for economic
operators across the EU. At the same time, lack of data does not allow to assess costs/benefits
options 2 (ACSH value).
Impact on Member States and proportionality
In the case of bromoethylene 22 Member States have no OEL for this agent or have one that is
less stringent than the value recommended by ACSH, so introduction of an OEL of 1 ppm
would require changes for a substantial number of MS. Figure 27 in Annex 9 illustrates the
ranges of existing national OELs compared to Option 2.
There is no data on numbers of exposed workers per Member State but it is possible that the
overall number of exposed workers in the EU is close to zero. An action taken at the European
Union level to achieve this objective could be justified as a way to ensure minimum basis of
protection against the risks arising from workers' exposure to this carcinogen.
5.13 Hydrazine
Exposure to hydrazine may increase the risk of lung and colorectal cancer. It is classified by
IARC as a Group 2B carcinogen (Possibly carcinogenic to humans), and as a Cat 1B carcinogen
in the EU under the classification and labelling legislation.
The principal applications of hydrazine solutions include chemical blowing agents, agricultural
pesticides and water treatment. Production levels in Europe are estimated to be around 20-25
thousand tonnes per year, and in the EU the largest producers of hydrazine are Germany and
France.
The risk estimates used in the IOM study for the assessment of health impacts are based on
existing epidemiologic evidence. Estimates of exposure prevalence in the manufacture of basic
chemicals for the EU were based on 2009 exposure prevalence data available for Finland
(although the Finnish exposure prevalence data may not be applicable to all EU countries). As
data on exposure prevalence in agriculture is not available, it is assumed that exposure
prevalence is similar to that of fungicide captafol (based on Italian 2005 data).
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Data on possible current exposure levels is extremely limited (the most recent data available is
from 1998 for Japan). Assuming a declining trend in exposure of 7% per year, the assumed
(upper) estimate of current exposure for high, medium and low group industries are of 0.7, 0.1
and 0.06 mg/m
3
, respectively.
In the EU, about 2,1 mln workers are estimated to be exposed to low levels of hydrazine, about
14,600 to medium levels (in agriculture) and 833 to high levels (in manufacturing of basic
chemicals). Overall, it is considered that about 8% of workers are exposed above 0.13 mg/m
3
,
and about 75% above 0.013 mg/m
3
.
Cost estimates include exposure control measures undertaken by firms in the manufacturing of
basic chemicals and in agriculture. As the number of firms potentially affected is not known, an
estimate is derived on the basis of the (estimated) number of workers potentially exposed,
combined with the available information on firm distribution by size. For agriculture, it is
expected that the costs related to use of hydrazine as a herbicide can be controlled through good
practice and use of appropriate personal protective equipment (PPE). No significant additional
costs are therefore expected, as the latter is already considered to be good practice. In the
manufacturing of basic chemicals, the installation of new local exhaust systems (LEVs) may be
required by some firms to ensure compliance. Estimates on the number of firms potentially
affected are subject to high uncertainty.
Table 34. Hydrazine – Types of impacts
Impact
Economic
Option 1
Baseline - no OEL
Under the baseline
scenario, there is
estimated to be a
reduction of exposure at
an annual rate of 7% until
2030 towards
0.013mg/m3 and below.
These estimates include
costs for PPE in
agriculture, as well as
some investment in
LEVs.
Option 2:
OEL at 0.013 mg/m
3
, Sk.
In total there is expected to be
around 2,100 firms in
agriculture and manufacturing
of basic chemicals affected by
an OEL at 0.013mg/m
3
.
No additional significant
costs for firms vs. the
baseline are expected. Once
the decline in exposure levels
under the baseline is factored
in, the resulting additional
total costs for complying with
the OEL would be in the
range of €5-32 mln.
Total attributable deaths for
2010-2069: 710. Total YLLs:
10,370. Total DALYs:
12,340.
Net health benefits are
estimated to be between
€0.01-0.05 mln.
Option 4:
OEL at 0.13 mg/m
3
, Sk.
In total there is expected to
be around 420 firms in
agriculture and
manufacturing of basic
chemicals affected by an
OEL at 0.13mg/m
3
.
No additional significant
costs for firms vs. the
baseline are expected. Once
the decline in exposure
levels under the baseline is
factored in, the resulting
additional total costs for
complying with the OEL
would be in the range of €2-
12 mln.
Total attributable deaths for
2010-2069: 710. Total
YLLs: 10,370. Total
DALYs: 12,340.
Net health benefits are
estimated to be between €0-
0.02 mln.
Social
Total attributable deaths
for 2010-2069: 710. Total
YLLs: 10,370. Total
DALYs: 12,340.
Total cancer-related
health costs for the 60-
year period are estimated
to be between €0.5 to €3
bln.
Environ
mental
None.
None.
None.
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Option 2 would be the most effective option in reducing occupational exposure to carcinogens
and levelling the playing field across the EU (as some MS already have set OELs at 0.013
mg/m
3
). In terms of compliance costs, in agriculture the costs related to use of hydrazine as an
herbicide can be controlled the use of appropriate personal protective equipment, which is
considered already as good practice. In manufacturing, no significant additional costs (vis-à-vis
option 1) are expected since the costs associated with purchase, maintenance and use of local
exhaust systems would have been incurred in any case under the baseline scenario, only
possibly more gradually over time.
Where there is the possibility of a significant uptake via dermal exposure SCOEL recommend
that any OEL be accompanied by a 'skin notation' (in the case of hydrazine ACSH did not
comment on this aspect of the SCOEL Recommendation). If adopted and accordingly
transposed by Member States, employers are required under the national transposing legislation
to take this into account in selecting appropriate risk management measures to protect workers.
Once the need for managing exposure has been established the only risk management measure
available in practical terms is to avoid skin contact. Hydrazine has a harmonised classification as
corrosive to the skin (category 1B) and skin sensitiser (category 1). These hazards would
normally result in employers taking steps to avoid skin contact as a part of routine OSH risk
control. Adoption of a 'skin notation' should therefore result in no additional cost for employers.
Table 35. Hydrazine – Comparison of options
Criteria
Option 1:
Baseline: no OEL
Option 2:
OEL at 0.013
mg/m
3
, Sk.
+
≈
+
Option 4:
OEL at 0.13 mg/m
3
, Sk.
≈
≈
+
Effectiveness
Efficiency
Coherence
Scientific advice
(SCOEL)
0
0
0
Categorised as a genotoxic carcinogen for which the existence of a threshold cannot
be sufficiently supported.
The systemic effects seen in animals following dermal contact warrant a 'skin
notation'.
ACSH
0.013 mg/m
3
.
Some Member States have already imposed nationally an OEL of 0.013 mg/m
3
, and there are
few concerns regarding technical feasibility. Compliance costs are small, not hampering
production processes nor business viability.
The opinion of the social partners and Member States in the ACSH supports option 2, and the
CMD further establishes an expectation that OELs be set where it is possible to do so.
Introducing an OEL would also be effective in introducing a greater clarity for economic
operators across the EU. At the same time, option 2 brings only a minor benefit, accompanied
by a limited cost for enterprises.
Impact on Member States and proportionality
In the case of hydrazine 24 Member States have no OEL for this agent or have one that is less
stringent than the value recommended by ACSH, so introduction of an OEL of 0.013 mg/m
3
would require changes for a substantial number of MS. The Figure 28 in the annex 9 illustrates
the ranges of existing national OELs compared to Option 2. Figure 29 in Annex 9 shows
distribution of exposed workers across the Member States.
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It is estimated that approximately 91% of exposed workers are located in those Member States.
An action taken at the European Union level could improve legal protection of exposed workers.
5.14 Summary of the retained options
It has been shown in the previous sections that the considered chemical agents vary
significantly. The table below summarises the retained options on the basis of several criteria:
i) Stakeholders' acceptance
For all the considered carcinogens the stakeholders represented in the ACSH support the
retained options. However, for a few there have been some dissenting opinions in the course of
the discussions. The following rating is applied:
- XX - full support in the ACSH;
- X - partial or conditional support in the ACSH.
It should be noted that in case of partial or conditional support by the stakeholders represented
in the ACSH, diverging views concerned e.g. ranges of values or feasibility considerations
rather than the principle of setting an OEL at EU level.
ii) Legal clarity
Introduction of OELs for all the considered chemical agents will improve legal clarity for
employers and workers. For some, however, the effect will be more significant as currently
fewer MS have introduced OELs corresponding to the advised level.
- XX - legal clarity will be improved in half or more of the MS
- X - legal clarity will be improved in less than half of the MS
iii) Size of the problem
The numbers of workers potentially exposed to the carcinogens vary substantially. While an
introduction of an OEL will be useful even if currently few workers are exposed (in the future,
due to new uses of the chemical agents this might change), an immediate impact will be greater
when exposed populations are bigger.
- XXX - - over 500,000 exposed workers
- XX - between 50,000 and 499,999 exposed workers
- X- less than 50,000 exposed workers
iv) Health benefit
There is also a divergence in the size of monetised health benefits of introducing OELs.
- XXX - benefits over 100 mln EUR
- XX - benefits between 10 mln EUR and 100 mln EUR
- X - benefits of less than 10 mln EUR
v) Limited costs for business
While all the retained options are expected to be feasible for business, there are different levels
of associated costs for business.
- XXX - costs below 10 mln EUR
- XX - costs between 10 and 100 mln EUR
- X - costs over 100 mln EUR
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Table 36
Name of the
chemical agent
Retained option
(ppm – parts per
mln, mg/m
3
or
f/ml - fibres per
ml)
1 ppm
1 ppm
5 ppm
0.1 mg/m
3
3 mg/m
3
0.025 mg/m
3
1 ppm
0.1 ppm
0.3 f/ml
0.1 mg/m
3
Stakeholders
acceptance
Legal
clarity
Size of the Health
problem
benefit
Limited
costs for
business
1,2
Epoxypropane
1,3 Butadiene
2 Nitropropane
Acrylamide
Hardwood dust
Chromium (VI)
compounds
Ethylene oxide
o-Toluidine
Refractory
Ceramic Fibres
(RCF)
Respirable
Crystalline
Silica
Vinyl chloride
Bromoethylene
(Vinyl bromide)
Hydrazine
XX
XX
XX
XX
X
107
X
108
XX
XX
X
109
X
110
XX
XX
XX
X
XX
XX
X
XX
XX
X
X
XX
XX
XXX
XXX
X
X
X
X
X
X
X
XX
XXX
X
X
X
XXX
XX
XXX
XXX
XXX
X
XXX
XXX
XXX
X
XXX
XXX
X
1 ppm
1 ppm
0.013 mg/m
3
XX
XX
XX
XX
XX
XX
X
n/a
XXX
X
X
X
XXX
XXX
XX
6
6.1
O
VERALL IMPACT OF THE PACKAGE OF RETAINED OPTIONS
Impact on workers
The retained options package (henceforth 'the retained option') should result in benefits in terms
of avoided work-related cancer cases and related monetised health benefits as follows:
107
ACSH agreed on an OEL of 3 mg/m
3
. However, during discussions, employers emphasised that some hand-held
machinery does not allow going below 5 mg/m3. On the other hand the workers favoured a 2 mg/m3. For some
MS, 3 mg/m3 is at the limit of feasibility particularly for SMEs while other MS favour a 1 mg/m3 limit to further
reduce occupational cancer cases.
108
ACSH agreed on an OEL of 0.025 mg/m3. However, during discussions, workers group argued that even a
binding limit of 0.025 mg/m3 would correspond to a high cancer risk. Employers' representatives did not make
any specific comments in the ACSH opinion.
109
ACSH agreed that an OEL was necessary but could not reach agreement on exact value (between 0.3 f/ml
and 0.1 f/ml). Employers advised to follow the recommendation of SCOEL (0.3 f/ml). They also stress that
industries have been working on a 0.5 f/ml exposure limit for many years, and further reductions of exposure are
technically difficult. Views of Member States ranged from 0.3 f/ml to 0.1 f/ml. The workers argued for an OEL
0.1f/ml. An OEL of 0.3 f/ml was taken forward in the proposal as the minimum common denominator.
110
ACSH agreed that a binding OEL at 0.1 mg/m3, measured as respirable dust, is justified. The value should
be reviewed within 3-5 years. There were some questions on the part of employers and some MS whether it
would not be more appropriate to legislate under the CAD. Workers stated that further exposure reduction below
the proposed binding OEL of 0.1 mg/m³ is paramount to reduce the risks of lung cancer, and silicosis.
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Respirable Crystalline Silica: an OEL at 0.1 mg/m
3
will provide for 99,000 avoided
cancer cases by 2069 for a total monetized health benefit quantified between 34 billion
and 89 billion EUR;
Hardwood dust: an OEL of 3 mg/m
3
will provide for a total monetized health benefit
between 12 million and 54 million EUR;
Benefits are also expected in relation to introducing a OEL at 0.025 mg/m
3
for all
chromium (VI) compounds, although it is likely these will have been overestimated as a
result of reductions in exposure which may be expected for some important compounds
when subject to REACH authorisation.
Remaining substances: The avoided cancer cases and the monetized health benefits are
less significant.
The introduction of retained option would decrease the burden of economic costs derived by
workers' exposure to hazardous substances. The main economic costs caused by disability and
premature death at work are:
the worker’s lost wages during the period of absence from work;
the subsequent severe consequences for household's well-being as well as a reduction in
tax collection.
By acting as a clear and homogeneous playing field for workers' rights enforcement, the
introduction of the retained option will reduce health and safety risks for disadvantaged workers
such as precarious and informal workers. The scientific literature (Aronsson, 1999; Quinlan and
Mayhew, 2000; Letourneux and Thebaud-Money, 2002) agrees in pointing out that precarious
workers have less control over fundamental determinants of their health and safety such as: the
ability to change temperature, lighting, ventilation, and work location, and the freedom to
choose when to take personal leave; and they are also more likely to be employed in dangerous
working environment.
As a consequence, the retained option have the advantage of shielding workers and families
from suffering financial and social costs which would otherwise occur in a baseline scenario.
It is important to note that the study underlying the Impact Assessment report was limited to
assessing health benefits resulting solely from avoided cancer cases. However, the chemical
agents under consideration cause a range of other occupational diseases. These include primarily
different forms of respiratory diseases (caused e.g. by hardwood dust, RCS, RCF) and
dermatological diseases (e.g. acrylamide, RCF). Enhanced workplace control of exposure to the
considered chemical agents will also contribute to decreasing the risk of those occupational
diseases.
The available data is not sufficient to estimate the magnitude of related health benefits.
However, taking into account general estimates of costs related to these diseases, it could be
expected that limiting the risks leading to their onset could be considerable.
Concerning occupational asthma, according to a review of existing research
111
, costs are related
to the poor prognosis of the disease and small chances for recovery.
112
Estimated 70% of
workers diagnosed with occupational asthma show symptoms even several years after complete
cessation of exposure
113
. According to estimates of the direct and indirect costs of occupational
asthma in the United Kingdom
114
, the average annual direct costs per case are £530-£715. The
111
Montano D. Chemical and biological work-related risks across occupations in Europe: a review. Journal of
Occupational Medicine and Toxicology (London, England). 2014;9:28. doi:10.1186/1745-6673-9-28.
Mapp CE, Boschetto P, Maestrelli P, Fabbri LM. Occupational Asthma. Am J Respir Crit Care Med.
2005;172(3):280–305. [PubMed]
Tarlo SM, Lemiere C. Occupational asthma. New Engl J Med. 2014;370(7):640–649. [PubMed]
Ayres JG, Boyd R, Cowie H, Hurley JF. Costs of occupational asthma in the UK. Thorax. 2011;66(2):128–133.
79
112
113
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annual indirect costs range from £1525 to £1685. The total costs of an average case to society is
some £120,000-£130,000. The total lifetime costs of new cases to society could lie between £95
and £135 million. Further research showed that some 49% of the present value total costs are
borne by the individual, 48% by the state and only 3% by the employer.
115
On the subject of occupational skin diseases the same research review quotes a study on costs of
occupational hand eczema, conducted in 2013 in Germany.
116
The annual direct and indirect
costs per worker diagnosed and treated were on average 2646 and 6152 EUR, respectively. An
Italian study estimated societal costs of severe chronic hand eczema to be on average 5016 EUR
per person-year (min. 411 EUR, max. 27648 EUR).
117
The need to conduct occupational
retraining, job change, or adverse psychosocial effects result in further costs.
118
As for severe
occupational skin diseases more than a half of all cases may become persistent and continue
even after exposure to a chemical agents discontinued, further direct and indirect costs might
occur depending on the degree of disability.
119
,
120
Also research conducted in Australia
confirmed that occupational skin diseases had a significant socioeconomic impact, with an
estimated annual cost of over $33 million.
121
6.2
Impact on businesses
From an economic standpoint, the total cost to an economy of occupational morbidity and
mortality is the sum of all private economic costs that are also social costs, plus the social costs
that are external to all private parties. Thus, the illness of a worker results in lost output for the
employer. If the worker is paid during the period of non-production, this mitigates the private
cost to the worker but increases the cost to the employer. A loss of production may lead to a loss
of profits, which would then be a social as well as private cost, but the firm might have the
ability to raise prices, maintain profits, and shift the cost to consumers.
As regards the economic impacts on costs incurred by enterprises for some carcinogens, the
retained option will affect operating costs for companies which will have to put in place
additional protective and preventive measures. This will be in particular the case for Chromium
(VI) compounds and RCS. As regards RCS, the total costs to industry of introducing an OEL at
0.1 mg/m
3
are estimated to be at 3.5 bln EUR until 2069
122
.
For the remaining carcinogens, the impact on operating costs and conduct of business (including
small and medium enterprises) will be minimal as only small adjustments will need to be done
in specific cases to ensure full compliance.
The retained option will not impose any additional information obligations and will not lead to
an increase in administrative burdens on enterprises.
115
Assessing the cumulative economic impacts of health and safety regulations - Scoping study. Prepared by the
Centre for Strategy & Evaluation Services (CSES) for the Health and Safety Executive 2009)
Diepgen TL, Scheidt R, Weisshaar E, John SM, Hieke K. Cost of illness from occupational hand eczema in
Germany. Contact Dermat. 2013;69(2):99–106. [PubMed]
Cortesi PA, Scalone L, Belisari A, Bonamonte D, Cannavo SP, Cristaudo A, Pita Od, Gallo R, Giannetti A, Gola
M, Pigatto PD, Mantovani LG. Cost and quality of life in patients with severe chronic hand eczema refractory to
standard therapy with topical potent corticosteroids. Contact Dermat. 2013;70(3):158–168. [PubMed]
Diepgen TL, Kanerva L. Occupational skin diseases. Eur J Dermatol. 2006;16(3):324–330. [PubMed]
Rycroft R, Frosch P. In: Contact Dermatitis, 4 edition. Frosch P, Menne T, Lepoittevin JP, editor. Berlin:
Springer; 2006. Occupational contact dermatitis; pp. 717–734.
Sajjachareonpong P, Cahill J, Keegel T, Saunders H, Nixon R. Persistent post-occupational dermatitis. Contact
Dermat. 2004;51(5–6):278–283. [PubMed]
http://www.safeworkaustralia.gov.au/sites/swa/media-events/media-releases/pages/mr16032012
Estimated costs of anticipating investment needed to reach the exposure level.
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116
117
118
119
120
121
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It is important, from an economic point of view, to distinguish between costs that do or do not
create incentives for improvements in health and safety. The advantages for businesses of
introducing EU wide OELs is that the new regulation will help firms addressing costs which
would, otherwise, negatively affect their business prospect in the long-term in the case of non-
compliance. According to the economic literature these costs are:
Economic - in this case these costs include unequal firms' costs related to differences in
the rate of depreciation of capital equipment or loss of raw material due to the existence
of different national OEL; in addition there are 'opportunity costs' – for instance if a firm
loses market share due to worker absences from ill-health; finally, company's loss of
'goodwill', which may result from well-publicized cases of industrial accidents or
disease, this is an opportunity cost to the firms which can have serious consequences;
Internal – if retained options are not adopted the enterprise run the risk to be considered
accountable for workers' ill-health;
Variable – the cost derived by workers' ill-health might not simply resolve in a fixed
premium compensation but might involve longer-term costs for the firm;
Routinely visible – cost derived by non-adoption of EU-wide OELs would increase
firms' exposure to expensive process of legal and economic information acquisition to
deal with the consequences of workers' ill-health.
Impact on SMEs
6.2.1
None of the considered options contain lighter regimes for SMEs. SMEs are not exonerated
from the obligation to eliminate or reduce to a minimum the risks arising from occupational
exposure to carcinogens or mutagens.
For many of the agents covered in this impact assessment, OELs exist already at national level,
even if the level as such differs between the EU Member States.
Establishing the OELs foreseen in this initiative should have no impact on those SMEs situated /
located in those EU Member States were the national OELs are either equal or lower than the
proposed values.
However, due to differences in OELs at national level there will in some cases depending on
industry practice be an economic impact in those Member States (and economic operators
established therein) which currently have higher OELs established for the chemical agents
subject to the initiative.
The major economic impact for SMEs can be summarised in three points. First, some of the
OELs have overhead costs, and the smaller the firm, the smaller the revenue base over which
these costs can be distributed. Second, the level of expertise is frequently lower for SMEs.
Third, the SMEs environment is generally more competitive and finance is more difficult to
obtain, leading to shorter time horizons and fewer expenditures on what may be perceived as
nonessential items different spending priorities – potentially reducing voluntary investment in
equipment or training which may be necessary to implement effective risk management.
The majority of companies that would be affected by the imposition of a RSC limit at 0.1 mg/m
3
are small companies. If the costs cannot be passed through to consumer prices and/or some
companies will not be able to get access to loans to pay for the necessary investment, there is a
possibility of some company closures and, for industries for which it is possible, some
relocation of activities in non-EU countries. The extent of this risk is difficult to estimate. 17 EU
Member States have already introduced an OEL of 0,1 mg/m
3
or below and also from this point
of view it appears to be feasible for the industry to adjust to such an exposure limit. Most of the
costs incurred in relation to it will be incurred by the construction industry, in which case
relocation is not a viable option, so companies are likely to pass the additional costs on to
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consumers to some extent. The fact that a majority of MS already have introduced the OEL
under consideration and that the same level exists in non-EU countries such as the US, Canada
or Australia, indicate that it should be feasible for the sectors concerned to absorb the additional
costs.
For chromium VI the IOM study assessed that the costs of compliance will notably affect small
firms employing less than 20 people, particularly in the manufacture of fabricated metal
products. It is possible that some could either close or cease to use chromium (VI) containing
components. However, those estimates are for all Chromium (VI) compounds and, as a result of
anticipated exposure reductions resulting from the impact of REACH authorisation on several
important compounds, both the costs and benefits can be expected to be overestimated. These
figures nevertheless represent the best and most appropriate available data to inform this
analysis.
SMEs indicated that OSH legislation in general creates some burdens, particularly in relation to
documenting risk management and reporting obligations (even if there is evidence that some
burdens might be related to national transposition rather than EU level legislation).
123
One of the
goals of a future revision of the OSH acquis may be to simplify and/or reduce administrative
costs, including for micro and small enterprises CMD limit values do not, however, result in
additional reporting or documenting obligations and the clarifications provided in Annexes I and
III should in fact decrease the burden on employers by providing clear guidance as for the scope
of application and the level of expected compliance.
Moreover, the European Association of Craft, Small and Medium-Sized Enterprises (UEAPME)
was among signatory parties of the Cross Industry initiative, which recognised 'EU-wide
Occupational Exposure Limits (OELs) as the most effective risk management option for
substances where there is a need to address a risk limited to the workplace' and called for the
Commission and Member States 'to proceed to set EU-wide OELs for substances, where a risk is
identified at the workplace'.
124
6.2.2
Impact on competition and competitiveness
Risk prevention and the promotion of safer and healthier conditions in the workplace are key not
just to improve job quality and working conditions, but also to promoting competitiveness.
Keeping workers healthy has a direct and measurable positive impact on productivity, and
contributes to improving the sustainability of social security systems. There is a correlation
between low levels of a country's rating as regards work-related deaths and diseases and its
competitiveness rank.
125
Implementing the retained option would have a positive impact on competition within the
internal market. Having EU-wide OEL for those agents will decrease competitive distortion
between firms located in Member States with different national OELs. Setting a minimum
standard at EU level will not (and should not) prevent Member States from setting even more
protective OELs. However, it will provide certainty that there is an enforceable exposure limit
for all concerned carcinogens in all Member States. It will also significantly minimise the scope
for variation in OELs across the EU. It may be noted that the examples of the current hardwood
dust and VCM OELs show that a majority of Member States in practice adopt the EU OEL
directly.
On the other hand, the retained option should not have a significant impact on the external
competitiveness of EU firms as many of the values proposed are similar to those in other
123
124
125
Commission follow-up to the 'Top Ten' Consultation of SMEs on EU Regulation (COM(2013) 446)
Further information on the initiative and source are provided in section 4.2.D.
Jukka Takala et al.: Global Estimates of the Burden of Injury and Illness at Work in 2012, available online:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4003859/
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countries (see Table 3 in Annex 6), notably EU largest trading partners, such as US, China or
Switzerland. For example, the proposed value for exposure to hardwood dust is 3 mg/m
3
while
the value in Canada and Australia is 1 mg/m
3
. The proposed value for vinyl chloride monomer
is 1 ppm, the value in the USA and Canada is also 1 ppm. And the value of 0.1 mg/m
3
proposed
for RCS is also established in the USA, Australia and Canada.
Furthermore, it is to be expected that in some of those third countries, limit values will also
continue to be adjusted to new scientific data. The US Occupational Safety & Health
Administration (OSHA), for example, recognizes that many of its permissible exposure limits
(PELs) are outdated and inadequate for ensuring protection of worker health. Most of OSHA’s
PELs were issued shortly after adoption of the Occupational Safety and Health (OSH) Act in
1970, and have not been updated since that time.
126
6.3
Impact on Member States/national authorities
Where no EU OEL exists many Members States conduct their own scientific analysis to
determine the acceptable exposure level. Exact costs of this type of exercise are difficult to
establish but would be significant given the level of scientific and technical expertise required.
The establishment of OELs at EU level eliminates the need for national public authorities to
independently evaluate each carcinogen thereby removing an inefficiency of repetition of
identical tasks.
Given the substantial economic costs imposed on workers due to their exposure to hazardous
substances, the retained option also contributes to mitigate financial loss of the Member State's
social security system. From an economic point of view, the coverage and adequacy of EU-wide
OELs is the single most important determinant of who bears the cost burden of occupational ill-
health.
Administrative and enforcement costs will differ according to present status of each chemical
agent in each MS, but should not be significant.
Based on the experience gathered from the work of the Senior Labour Inspectors Committee
(SLIC) and having regard to the way the enforcement activities are organised in different MS it
is not likely that the introduction of new OELs in the CMD would have any impact on the
overall costs of the inspection visits. Those are mostly planned independently of the revised
legislation, mainly based on complaints filed during a given year and according to the inspection
strategies defined by a given authority. On the other hand, the existence of an OEL, by bringing
clarity regarding the acceptable levels of exposure, facilitates the work of inspectors by
providing a helpful tool for compliance checks.
Additional administrative costs might be incurred by authorities as regards the necessity to
provide information and training on the revision to staff, as well as to revise the compliance
checklists. However, these costs are minor in comparison to the overall costs of functioning
incurred by the enforcement authorities.
6.4
Impact on fundamental rights
The impact on fundamental rights is considered positive - in particular with regard article 2
(Right to life) and article 31 (Right to fair and just working conditions which respect his/her
health, safety and dignity).
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https://www.osha.gov/dsg/annotated-pels/
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6.5
How does the retained option conform to the principles of subsidiarity and
proportionality given the size and nature of the identified problem?
The protection of workers health against risks arising from exposure to carcinogens is already
covered by EU legislation, in particular by Directive 2004/37/EC (CMD) and the REACH
Regulation. Amending Directive 2004/37/EC can only be done by action at EU level and after a
two-stage consultation of the social partners (management and labour) in accordance with
Article 154 TFEU.
With regard to the values proposed as retained option it has to be stressed that socio-economic
feasibility factors have been taken into account after long and intensive discussions with all
stakeholders (representatives from employees' associations, representatives from employers'
associations, and representatives from governments).
While monetised benefits of the initiative may be modest, it should be recalled that the initiative
would contribute to saving 100,000 human lives in the forthcoming 50 years. These figures are
based on the estimations made the IOM study contracted by the Commission
127
. There is a range
of additional benefits which have not been quantified (e.g. benefits related to avoided cases of
other occupational diseases caused by the chemical agents, positive effects on level playing
field, facilitation of legal compliance and enforcement etc.).
The subsidiarity and proportionality check done for each specific agent, indicated that, where
relevant data was available, introduction of proposed OELs would improve legal protection for
an estimated 33% to 98% of exposed workers (see Table 4 in Annex 6).
In addition, the proposal does not set levels to be directly translated into national legislation but
maximum limits. Member States can decide to introduce lower levels.
The planned action therefore complies with the principles of proportionality and subsidiarity.
7
H
OW WOULD ACTUAL IMPACTS BE MONITORED AND EVALUATED
?
This section presents the monitoring and evaluation arrangements that seem most appropriate at
this stage in order to monitor and evaluate the planned legislative initiative. It should however
be noted that the overall OSH legislative framework has just undergone a comprehensive
evaluation. As a result of this, the Commission might decide to modify the monitoring and
evaluation mechanisms currently foreseen in this framework. This would clearly have an impact
on the monitoring and evaluation arrangements of the individual Directives within the OSH
framework, including the CMD.
7.1
Monitoring arrangements
The reduction of occupational diseases and occupational related cancer cases in the
European Union;
The reduction of costs related to occupational cancer for economic operators and for
social security systems in the European Union.
The operational objectives for the retained option, in relation to the chemical agents covered are:
The table below presents the core indicators for each operational objective and the data sources
for the monitoring of the core indicators.
127
Deaths avoided mainly in relation to the following chemical agents: Chromium VI - 1670; Refractory Ceramic
Fibres - 50; Respirable Cristalline Silica - 98,670.
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Table 37
Operational
objective
The reduction of
occupational
diseases and
occupational
related cancer
cases in the
European Union
Indicators
The number of
occupational
diseases and
occupational
related cancer
cases in the EU
Monitoring arrangements/data sources for
monitoring indicators
The reduction of
costs related to
occupational
cancer for
economic
operators and
for social
security systems
in the European
Union
The data sources for the monitoring of this indicator are:
- data that could be collected by Eurostat on occupational
diseases if the results of the on-going feasibility study are
positive, as well as on and other work-related health problems
and illnesses in accordance with Regulation (EC) No
1338/2008.
128
-data notified by employers to the competent national
authorities on cases of cancer identified in accordance with
national law and/or practice as resulting from occupational
exposure to a carcinogen or mutagen in accordance with Art.
14 (8) of Directive 2004/37/EC, and which may be accessed
by the Commission in accordance with Article 18 of Directive
2004/37/EC;
-data submitted by Member States in the national reports on
the implementation of EU OSH acquis, submitted in
accordance with Art. 17a of Directive 89/391/EEC
The costs related to The monitoring of this indicator will require the comparison
occupational
of the expected figures on the burden of occupational cancer
cancer for
in terms of economic loss and health care costs and the
economic operators collected figures on these matters after the adoption of the
(e.g. loss of
revision. The productivity loss and health care costs can be
productivity) and
established on the basis of the data on the number of
social security
occupational cancer cases and the number of occupational
systems in the
cancer deaths (the arrangements for the collection of the data
European Union.
on occupational cancer cases are described supra in this
table).
The monitoring of implementation (transposition and application) is also an indicator of the
effectiveness of the initiative to reach its operational objectives. A compliance assessment will
be carried out for the transposition of the limit values, by the Commission in two stages: a
transposition check and conformity check. The monitoring of application and enforcement will
be undertaken by the national authorities in charge of the protection of workers' health and
safety and in particular the national labour inspectorates. Information on the practical
implementation of the Directive 2004/37/EC at national level is provided every five years by the
Member States in accordance with Article 17a of Directive 89/391/EEC. At EU level, the
Committee of Senior Labour Inspectors ('SLIC') established by Commission Decision
95/319/EC, informs the Commission on all problems relating to the enforcement of EU OSH
Directives, including Directive 2004/37/EC.
129
7.2
Evaluation arrangements
In accordance with the ex-post evaluation clause in Art. 17a of Directive 89/391/EEC, every
five years, Member States are required to submit a single report to the Commission on the
practical implementation of the EU OSH Directives. This report includes a chapter dealing with
128
Regulation (EC) No 1338/2008 on Community statistics on public health and health and safety at work, OJ L
354/70, 31.12.2008.
In particular, the SLIC Working Group CHEMEX is mandated to gather, exchange and disseminate information
and guidelines for national labour inspectorates on enforcement matters related to chemical exposures in
workplaces, and in particular for carcinogenic, mutagenic, reprotoxic or sensitising chemical agents.
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the implementation of particular aspects of Directive 2004/37/EC, including specific indicators,
where available. On this basis, the Commission will evaluate the implementation of Directive
2004/37/EC in terms of its relevance, of research and of new scientific knowledge, in
accordance with Art. 17a (4) of Directive 89/391/EEC.
In accordance with Art. 17a of Directive 89/391/EEC, the Commission is required, within 36
months of the end of the five-year period, to inform the European Parliament, the Council, the
European Economic and Social Committee and the Advisory Committee on Safety and Health
at Work of the results of this evaluation and, if necessary, of any initiatives to improve the
operation of the regulatory framework.
Given the data challenges explained earlier in this report it is suggested to made use of the next
ex-post evaluation exercise to define the baseline values (benchmark) that will allow assessing
the effectiveness of the planned CMD revision. This seems reasonable considering that due to
the long latency periods to develop cancer (10 to 50 years), it will not be possible to measure the
real impact of the revision before 15-20 years.
Availability of exposure data is presently the subject of a contract study ('HazChem@Work').
130
It will in due course also contribute to the definition of the benchmark and may enable some
further conclusions to be drawn about the effectiveness of the proposed measure. For the
foreseeable future, however, the latency of some occupational cancers and other well-explained
difficulties in collecting and aggregating exposure data between member states will continue to
present significant challenges to their use as indicators.
In that context aggregating exposure data collected from Member State labour inspectorates at
EU level could have several important benefits for operation of chemicals policy – but would be
a very significant additional burden on both national labour inspectorates and possibly
employers. It is also unlikely that such data could in any case be effectively aggregated as
reporting structures within companies and between sectors and Member States are unlikely to
align.
130
Call for tender no. VT/2013/079. Service contract to create a database and develop a model to estimate the
occupational exposure for a list of hazardous chemicals in the Member States of the European Union and the
EFTA/EEA countries. The contract with the successful bidder, VC/2014/0584, was signed on 23 July 2014.
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Annexes
8
8.1
A
NNEX
1 – P
ROCEDURAL
I
NFORMATION
Lead DG
Concerning the process to prepare the impact assessment report and the related initiative.
Lead DG: Directorate-General Employment, Social Affairs and Inclusion, Unit B/3 Health,
Safety and Hygiene at Work
8.2
Consultation of the Regulatory Scrutiny Board (RSB)
The Impact Assessment report was reviewed by the RSB in a meeting on 17 February 2016. The
RSB required a number of improvements.
The revisions introduced in response to the RSB comments are summarised in the table below:
RSB main recommendations
(1) Context of the initiative and links with the
evaluation.
further present the heterogeneous landscape in
Europe;
Changes done to the IA
Further information on the situation across the EU
(e.g. ranges of existing national OELs, Member States
most affected) provided for each of the chemical
agents in Section 5 (sections 5.1-5.13) and in Annex 9.
The OEL setting process, as well as the steps taken to
facilitate swifter future updates, is explained in greater
detail in section 4.3.
more thoroughly explain the procedure to
update OELs and measures taken to further
streamline it;
make links with the OSH evaluation findings.
The new section 2.4.focuses on the links with the
OSH evaluation.
(2) Need to act and EU added value of the
initiative.
further substantiate why diverging national
OELs are inefficient and why action is
required at EU level;
further substantiate the added value of
providing legal clarity;
better explain the interest of different
stakeholders (including employers) in setting
EU standards;
weigh the overall benefits of the initiative
(possibly including health gains related to the
prevention of diseases other than cancer and
results of enhanced clarity for businesses)
against its total costs.
Sections 1.1.3, 1.3., 2.2. have been considerably
developed in order to better demonstrate the
inefficiency of diverging national OELs, the added
value of greater legal clarity and the interests of
different stakeholders.
A summary table has been introduced under section
5.14, weighing the retained option for each of the
chemical agents against a number of criteria, including
compliance costs and health benefits.
Additional data under section 6.1. provides
quantitative estimates of the health benefits related to
diseases, such as occupational asthma and
occupational skin diseases.
(3) Impacts on and views of stakeholders.
more systematically present the views of
different stakeholders and the expected
impacts on particular groups (incl. SMEs),
distinguishing when relevant between MS and
between specific substances.
views on the importance of burden reduction
and simplification of the OSH legislation in
Further information, where available, included for
each of the chemical agents in Chapter 5 (sections 5.1-
5.13).
New section 2.4. deals with the issue of simplification.
Further discussion on burden reduction is included in
the conclusions (sections 6.2.1. and 6.3).
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general should be addressed.
(4) Alternative options.
better explain why a broader range of
approaches, including non-legislative ones,
were not considered or were discarded;
reasons for discarding them should be
summarised;
assess in more details the feasibility and
consequences of covering the chemicals
included in this initiative through REACH.
Procedure and presentation.
further explain the limitations of the data used
and their potential effect on the quantification
of impacts.
Whenever relevant, a sensitivity analysis
should be applied.
A new section (4.2) presents a broader range of
alternative approaches (including non-legislative and
REACH) and the reasons for discarding them.
Further explanations on methodology, assumptions
and data limitations is provided in the introductory
part of Chapter 5 as well as per chemical agent, where
available, in sections 5.1-5.13.
A sensitivity analysis regarding the discount rate has
been conducted and confirmed that benefits were far
more sensitive to discounting than costs. Costs and
benefits have been recalculated using a declining
discount rate instead of the originally used fix 4%
discount rate. The analysis also further clarifies what
compliance costs would need to be incurred under the
baseline scenario and under each of the options for
action.
The RSB issued a positive opinion on 1 April 2016 and several further adjustments were made
in the text of the report following RSB's further suggestions, as summarised in the table below.
RSB main recommendations
(1) Costs
Costs presented in the report should only be
those incurred compared to the baseline, i.e.
resulting from the obligation to respect the
OEL proposed through a binding measure in
the near future compared to reaching it later
through the "natural" linear decrease in
exposure.
(2) Value added at EU level
Need to extend the range of considered
options. In particular, in order to provide legal
certainty by industry, there could be the need
to set OELs by industry or use of a specific
product. As this risks to become very
burdensome for the regulators, an alternative
option could be to provide scientific
information by industry and use, without
setting OELs.
(3) Stakeholders support
Two additional options have been added in section
4.2.
Changes done to the IA
Sections 5.1-5.13 have been revised accordingly.
Further explanation on EU added value have been
added in section 1.1.3
The report should further expand on the The IA report includes already opinions of
perception of stakeholders regarding the stakeholders relevant for each substance in sections
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establishment of OELs at European level for 5.1-5.13 of the report.
specific substances as opposed to national
level. This is especially important as Further clarification has been provided in the section
stakeholder support seems to be inversely 5.14.
proportionate to the size of the problem (and
potential health benefits – Table 36, p.80).
(4) OSH vs. REACH
Introduce a table comparing the OSH
framework and REACH as possible
instruments to reduce EU workers' exposure
to carcinogens.
A table has been added in section 14.2.3.
(5) Presentation
Finally, the estimation of 100,000 lives
potentially saved through the proposed
measures (pp.7, 87) should be more clearly
explained and substantiated
The information requested is reflected in changes
made in the introduction, and in section 6.5.
8.3
8.3.1
Evidence used in the impact assessment
IARC Monographs
Various IARC Monograph have been used as evidence in preparation of the impact assessment.
The exact source of which monograph has been used for each individual chemical agents is
provided for in Annex 5 of this document.
Through the Monographs programme, IARC seeks to identify the causes of human cancer. The
criteria established in 1971 to evaluate carcinogenic risks to humans were adopted by the
Working Groups whose deliberations resulted in the first 16 volumes of the Monographs series.
Those criteria were subsequently updated by further Ad-hoc Advisory Groups (IARC 1977,
1978, 1979, 1982, 1983, 1987, 1988, 1991, 1992, 2005, 2006).
As stated in the preamble of the Monographs, "the objective of the programme is to prepare,
with the help of International Working Groups of experts, and to publish in the form of
Monographs, critical reviews and evaluations of evidence on the carcinogenicity of a wide range
of human exposures. The Monographs represent the first step in carcinogen risk assessment,
which involves examination of all relevant information in order to assess the strength of the
available evidence that an agent could alter the age-specific incidence of cancer in humans. The
Monographs may also indicate where additional research efforts are needed, specifically when
data immediately relevant to an evaluation are not available".
131
The scope of the programme nowadays now include specific chemicals, groups of related
chemicals, complex mixtures, occupational or environmental exposures, cultural or behavioural
practices, biological organisms and physical agents.
131
http://monographs.iarc.fr/ENG/Preamble/CurrentPreamble.pdf
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For further information on for example the selection of agents, the data used for the
Monographs, the selection of experts, the working procedures etc. can all be found in detail in
the preamble of the monographs (see above reference).
8.4
8.4.1
External expertise
Use of scientific expertise / Commission expert groups / SCOEL
The Scientific Committee on Occupational Exposure Limits for Chemical Agents was set up by
Commission Decision 95/320/EC
132
to evaluate the health effects of chemical agents on workers
at work. The work of the Committee directly supports Union regulatory activity in the field of
occupational safety and health. It develops high quality comparative analytical knowledge and it
ensures that Commission proposals, decisions and policy relating to the protection of workers’
health and safety are based on sound scientific evidence.
The Committee assists the Commission, in particular, in evaluating the latest available scientific
data and in proposing occupational exposure limits for the protection of workers from chemical
risks, to be set at Union level pursuant to Council Directive 98/24/EC and Directive 2004/37/EC
of the European Parliament and of the Council.
Members of SCOEL are highly qualified, specialized, independent experts selected on the basis
of objective criteria. They are appointed in their personal capacity and provide the Commission
with Recommendations and Opinions that are necessary for the development of EU policy on
workers protection.
For the purpose of this initiative, the Commission services have used the relevant chemical
agent-related SCOEL recommendation. The exact reference for the recommendation used for
each individual chemical agent is provided for in Annex 5 of this document.
8.4.2
Studies performed by external consultants
Study on health, socio-economic and environmental aspects of possible amendments to the EU
Directive on the protection of workers from the risks related to exposure to carcinogens and
mutagens at work
Following the two stage consultation of the European social partners (see section 9.1 of this
document), DG EMPL/F/4 published on 25 July 2008 an open call for tender in order to carry
out an assessment of the social, economic and environmental impacts of a number of policy
options concerning the protection of workers health from risks arising from possible exposure to
carcinogenic chemical agents at the workplace.
The main outputs expected were a study report containing full reports on 25 carcinogenic
chemical agents and two other policy issues relating to the effectiveness of risk management
measures and risk based criteria for the setting of occupational exposure limit values.
The contract started on 24 April 2009 and run until 27 April 2011.
The outcome of this study (summary report and individual chemical agents' reports) provides
the main basis for this Staff Working Document and are summarised in the relevant sections of
this document. The executive summary report, the summary report as well as the reports for the
individual chemical agents are available on the internet.
133
.
132
Commission Decision 95/320/EC of 12 July 1995 setting up a Scientific Committee for Occupational Exposure
Limits to Chemical Agents (OJ L 188, 9.8.1995, p. 14)
The following links are only provided for those chemical agents subject to the first amendment of the CMD:
- Executive summary report
- Summary report
- 1,2-Epoxypropane
- 1,3-Butadiene
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8.4.3
Study on chemical agents toxic to reproduction
DG EMPL/F/4 published on 22 May 2010 an open call for tender in order analyse at EU-level
the socioeconomic and environmental impact in connection with possible amendment to
Directive 2004/37/EC to extend the scope to chemical agents toxic to reproduction, category 1A
or 1B according to the CLP Regulation.
The underlying consideration was, that under the REACH Regulation these chemical agents are
considered as chemical agents of very high concern (SVHC), meaning that they might become
subject to the so-called authorisation procedure, which in a nutshell foresees that they cannot be
placed on the market of the EU unless the supplier demonstrates in a dossier that the use of the
chemical agent is safe.
However, based on the current scientific knowledge, the majority of these chemical agents have
a threshold below which a safe use of the chemical agent is possible. Therefore, it can be argued
that the protection of workers is already covered under the CAD, and that Indicative OELVs or
OELs for these chemical agents should be established under the CAD, and the more stringent
protective and preventive measures under the CMD, in particular with regard to the substitution
provision, are not proportionate.
Nevertheless, and following in particular the request from the workers interest group of the
ACSH (see also information provided in Annex 2 of this document – Social Partner
Consultation), the study was launched in order to complement the available data to enable the
Commission to take an informed decision.
The contract started on 30 November 2010 and the final report was submitted to the
Commission in February 2013.
However, the results of the study did not provide sufficient evidence that including these
chemical agents under the scope of the CMD would lead to a higher protection of workers.
- 2 Nitropropane
- Acrylamide - Bromoethylene
- Chromium VI
- Ethylene oxide
- Hydrazine
-
o-Toluidine
- Refractory Ceramic Fibres
- Respirable Crystalline Silica
- Hardwood dust
- Vinyl chloride monomer
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9
9.1
A
NNEX
2 - S
TAKEHOLDER CONSULTATION
Social partner Consultation
The TFEU foresees a two stage consultation of the European social partners for legislative
initiatives in the field of social policy (article 154, ex Article 138 of the EC Treaty).
The Commission launched the first stage of consultation of the social partners on the protection
of workers from risks related to exposure to carcinogens, mutagens and chemical agents toxic
for reproduction at work on 6 April 2004. In accordance with Article 154(2) of the TFEU
(former Article 138(2) of the EC Treaty), the social partners were asked to give their opinions
on the possible direction of EU action in this field.
The first phase of the consultation confirmed that action needs to be taken at Community level
to introduce better and standardised methods across the EU, and to tackle situations involving
workers' exposure.
All the European social partners who replied by the end of the six-week consultation period to
the consultation
134
underlined the importance they attached to protecting workers from the
health risks associated with exposure to these chemical agents.
However, while all respondents acknowledged the relevance of the existing legislation, their
views differed as to the strategy and direction of future action and which factors should be taken
into consideration.
135
For example, whereas five organisations representing trade union umbrella organisations or the
British Occupational Hygiene Society considered to be appropriate to amend or update the
CMD, three other organisations representing employers felt that priority should be given to
practical guidance documents and enhanced sectorial prevention.
Regarding the extension of the scope of the CMD to cover chemical agents toxic for
reproduction and the inclusion of more limit values in the Directive most replies were in favour
of an EU initiative. On the other hand, social partners' organisations suggested that national and
sectorial approaches were more appropriate to tackle the specific issue of workers exposure to
environmental tobacco smoke.
Following the first phase of consultation and due to the classification of respiratory crystalline
silica as carcinogenic category 1 (proven carcinogen to humans) by IARC, the social partners of
the sectors producing (quarries) and using silica (construction, glass, metal industry,
pharmaceutical, etc.) embarked on negotiations in view of a European cross-sectorial agreement
for the prevention of exposure to silica respirable dust. Worker's organisations agreed to
negotiate on the condition that any future agreement would be without prejudice of any EU
initiative setting adequate levels of protection at EU level.
Once the Silica agreement was signed in 2006, the Commission launched on 16 April 2007 the
second stage of consultation of the European social partners, in accordance with Article 154(3)
of the TFEU on the content of the envisaged proposal.
The specific points for consultation were: 1) Inclusion of chemical agents toxic for reproduction
(categories 1A and 1B) in the scope of CMD; 2) Updating OELs for chemical agents in Annex
134
Union of Industrial and Employers' Confederations of Europe (UNICE), European Centre of Enterprises with
Public Participation and of Enterprises of General Economic Interest (CEEP), European Association of Craft,
Small and Medium-Sized Enterprises (UEAPME), European Trade Union Confederation (ETUC), European
Confederation of Executives and Managerial Staff (CEC), Confederation of National Associations of Tanners
and Dressers of the European Community (COTANCE), Hotel, Restaurants and Cafes in Europe (HOTREC),
European Federation of Trade Unions in the Food, Agriculture and Tourism Sectors and Allied Branches
(EFFAT), Union Network International – Europe Hair & Beauty (UNI-Europa Hair&Beauty)
CISNET EMPL 8676 of 15 June 2006
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III of CMD; 3) Including OELs for more chemical agents in Annex III of CMD; 4) Introducing
criteria for setting OELs for CMR chemical agents; and 5) Focus on training and information
requirements.
The Commission received replies from seven European social partner organisations: four from
employers' organisations (Business Europe, Eurocommerce, European Association of Craft
Small and Medium-sized Enterprises (UEAPME) and European Cement Industry), two from
workers organisations (European Trade Union Confederation (ETUC), and European Federation
of Building and Woodworkers (EFBWW)) and one from an independent organization (British
Occupational Hygiene Society (BOHS)).
In their replies these organizations reaffirmed their approach to the prevention of occupational
risks derived from carcinogens and mutagens at work, as outlined in their responses to the 1st
stage consultation document. The opinions gathered are summarized below:
Inclusion of chemical agents toxic for reproduction (categories 1A and 1B) in the scope of CMD
There was no agreement
on the need to initiate a EU level action, neither in the extension of
the scope of the Directive to include reprotoxic chemical agents of categories 1A and 1B
according to the CLP Regulation. Employers thought that the effective application of the
existing legal framework is enough to attain a suitable level of protection, whilst workers called
on the Commission to make legislative changes and to commit to eliminate exposure to
occupational carcinogens by 2025. Workers took a positive view in order to extend the scope of
the Directive to cover reprotoxic chemical agents. The possibility of launching the negotiation
procedure under Article 154 (4) and 155 of the Treaty was not agreed.
Updating OELs for chemical agents in Annex III of CMD and including OELs for more
chemical agents in Annex III of CMD
There was
a partial agreement
on the revision of existing binding OELs and on the
establishment of new OELs for chemical agents not yet listed in the Directive Annex III of the
Directive. While workers indicated a positive attitude based on the fact that it shall ensure
equivalent protection of workers at EU level, the employers have expressed their scepticism
reasoning that this action could only be justified on the grounds of an evaluation of the Directive
98/24/EC on chemical agents, on the grounds of robust scientific evidence and under the
condition that socio-economic and feasibility factors must be taken into account. Furthermore,
the revision of binding OELs should be examined in the light of the implementation of the
REACH Regulation and of the relationship and interaction between OELs and DNELs (Derived
Non Effect Levels) which will be derived under REACH for hazardous chemicals.
Introducing criteria for setting OELs for CMR chemical agents
There were no significant divergences
between the replies of both employers and workers on
the methodologies to be used and the criteria to be set up for the derivation of OELs. The
introduction of criteria for OELs setting was seen as generally positive. However, socio-
economic impact assessments and the consideration of feasibility factors should be part of the
criteria. Social partners expressed the view that the ACSH should be involved.
Focus on training and information requirements
There was an overall agreement
on the need for effective implementation of training and
information requirements. This issue is considered to be a key aspect of the prevention policy.
Workers call the Commission to set up a strategy to improve coordination and sharing of
information at EU level. Employers see an added value on the preparation of guidance
documents with recommendations on workers protection against carcinogens and mutagens
exposure.
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Following the results of the Social Partners consultation, the Commission tendered a study to
assess socio-economic aspects of revising OELs and introducing new ones (see point 8.4.2). The
results of the study as well as SCOEL recommendations, where available, were subsequently
discussed by the tripartite ACSH (see point 9.2.3). The discussions resulted in agreement on
limit values, which have been taken forward to this initiative.
9.2
9.2.1
Other consultation of stakeholders
25 October 2006 - Workshop of setting OELs for Carcinogens
In 2006, DG EMPL organised in collaboration with the ACSH a workshop on “Setting OELs for
Carcinogens”. The key questions addressed during the workshop were the following:
What is the acceptable/unacceptable level of risk?
What is the maximum level of risk?
Is it possible to quantify it in terms of incidence rate versus the number of exposed
workers?
In accepting risk levels should a distinction be made for general public and workers?
What criteria are used in some Member States and what political decisions have been
taken in respect to the OEL setting process for carcinogens?
What criteria should be used to define the border between the acceptable and unacceptable
risk?
Should
the
approach
to
address
the
risk
(quantitative/semiquantitative) or stochastic (case by case)?
levels
be
systematic
Should criteria on the acceptability of risks be regulated at EU level?
Should the workability of the existing EU legal framework be safeguarded versus
subsidiarity, in terms of establishment of OELs for carcinogens?
One of the main conclusions of the workshop was that the existing EU OSH legal framework
and its supportive administrative, technical and scientific structure should remain in place and
be used for the derivation and adoption of OELs at the EU level. However, it was also
acknowledged that the derivation of OELs for Carcinogens, Mutagens and Reprotoxic chemical
agents (CMRs) - both genotoxic and non-genotoxic - is a demanding task. The availability of
sound and sufficient evidence, and in
particular the availability of criteria and methodologies for
their derivation, is a critical prerequisite for setting OELs for carcinogens.
More than 80 scientists, technicians and academics contributed to the discussions.
9.2.2 EU-OSHA - Exploratory survey of Occupational Exposure Limits (OELs) for
Carcinogens, Mutagens and Reprotoxic chemical agents (CMRs) at EU Member States
level (published in September 2009)
136
Between late 2007 and early 2008, EU-OSHA, at the request of the European Commission,
carried out a survey among its network partners aiming at increasing the Commission's
knowledge on the existing situation at national levels concerning OELs for CMRs.
Part of the survey was to collect data on existing OELs values for CMRs from the 27 Member
States and from selected countries outside of the EU (Australia, Canada, Japan and US). In
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https://osha.europa.eu/sites/default/files/publications/documents/en/publications/reports/548OELs/survey_OELs_
CMR_substances_web_def.pdf
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addition, information was required on the
methodology and criteria (scientific, technical and
socioeconomic) used when setting an OEL for a carcinogen or a mutagen.
Based on the feedback received, the final survey covered 21 Member States
137
.
With regard to the current initiative it is worth noting that the chemical agents covered by this
initiative are in most cases also included in national OEL lists for carcinogens and mutagens.
The majority of the MS which reported back have between 30 to 50 OELs established for
carcinogenic and / or mutagenic chemical agents (Belgium,
Czech Republic, Denmark, Estonia,
Latvia, Lithuania, the Netherlands, Portugal, Slovakia, Slovenia, and UK), and only 4 EU MS
(Austria, Finland, Poland and Spain) have listed a higher number than 50.
With regard to the selection and prioritization of carcinogenic and mutagenic chemical agents
for OEL setting, it is also important with regard to the current initiative that criteria used in EU
Member States are very similar to those used in the EU.
Based on the answers of 11 countries, the most important criteria for the selection of chemical
agents for setting of OEL appear to be (in order of priority): (1) epidemiological evidence,
including reported cases of ill-health in the workplace, (2) availability of toxicological data, (3)
severity of effects, (4) number of persons exposed, (5) availability of data on exposure, and (6)
availability of measurement methods.
Results of the survey have been used to put together the lists of existing OELs in Annex 6.
9.2.3 Consultation of the tripartite Working Party "Chemicals at the Workplace" (WPCs) of the
ACSH
Following the Social Partner Consultation, the Commission informed the members of the WPC
at its meeting in April 2008 on its intention to propose a revision of the CMD. Information were
provided on a possible launch of a call for tender during 2008 with a view to appointing a
contractor to carry out an impact assessment of possible amendments of the Directive, covering
amongst other the inclusion of certain PGSs in Annex I to the Directive and the revision of
existing and the introduction of new OELs for a number of chemical agents in Annex III to the
Directive (the so-called IOM study).
At that point in time, the Commission confirmed that the option of covering chemical agents
toxic for reproduction under the scope of the revised Directive was now excluded by the
Commission. However, in 2010, the Commission launched another call for tender for a study to
explore whether or not these chemical agents should be under the scope of the CMD (the so-
called RPA study).
At various meetings of the WPC, the progress on the studies was discussed
138
, followed by a
first more in-depths discussion on the results of the IOM study based on draft reports for
individual chemical agents in March 2011. The discussions on the individual chemical agents
took place at various meetings of the WPC in 2011
139
, 2012
140
and 2013
141
, resulting in one
137
Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Italy, Latvia,
Lithuania, Luxembourg, the Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden and the United
Kingdom
Meeting of the WPC on 15 October 2008; Meeting of the WPC on 26 March 2009; Meeting of the WPC on 20
October 2010;
Meeting of the WPC on 23 March 2011; Meeting of the WPC on 15 June 2011; Meeting of the WPC on 26
October 2011
Meeting of the WPC on 21 March 2012; Meeting of the WPC on 6 June 2012; Meeting of the WPC on 21
November 2012
Meeting of the WPC on 6 March 2013; Meeting of the WPC on 19 June 2013; Meeting of the WPC on 2
October 2013
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139
140
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opinion and two supplementary opinions adopted by the plenary of the ACSH in 2012
142
and
2013
143, 144
.
The OEL values agreed upon by the ACSH were taken forward to this initiative.
9.2.4
September 2012 - Workshop in Berlin
A workshop ‘Carcinogens and Work-Related Cancer’ was organised by the European Agency
for Safety and Health at Work (EU-OSHA) and hosted by the German Ministry of Labour and
Social Affairs at their offices in Berlin on 3 and 4 September 2012. About 60 representatives
from various European countries, the European Commission, the Advisory Committee on Safety
and Health’s Working Party on Chemicals, the Chemex group of the Senior Labour Inspectors
Committee (SLIC), the Scientific Committee on Occupational Exposure Limits (SCOEL), the
European Chemicals Agency and the International Agency for Research on Cancer (IARC) of
the World Health Organisation (WHO) attended.
The aim of the workshop was to summarize the current understanding regarding exposures to
carcinogens and the causes and circumstances of work-related cancer, and to discuss how this
knowledge can be used across the European Union (EU) to reduce the future burden of these
cancers.
The workshop
145
highlighted the need to enhance research efforts to estimate the burden of
occupational disease and build on links between occupations and exposures to set priorities for
prevention, disease recognition and compensation. In this regard the on-going study
HazChem@Work will collect the available occupational exposure data on chemicals across the
EU countries. Interim results of this study have shown difficulty in finding data on occupational
exposure as it is not routinely collected and centralised at the national level. It is been also
identified that the measurements can be performed under different conditions and for different
purposes – this can hamper the comparability among different data sets. The final results are
expected by the second semester of 2016.
It was generally agreed that the current legislative framework in Europe and its implementation
and enforcement is essential for the effective prevention of cancer in the workplace. The need to
provide the same level of protection to all workers was also stressed.
9.2.5
Consultation of the members of the ACSH on existing national OELs for chemical agents
subject to the amendments
In order to establish a base-line scenario for the establishment of OELs subject to the initiative,
the Commission services requested from the members of the ACSH at its plenary meeting on 28
November 2013 to submit updated information on the national OELs for the chemical agents
covered by the IOM study.
142
Opinion on the approach and content of an envisaged proposal by the Commission on the amendment of
Directive 2004/37/EC on Carcinogens and Mutagens at the workplace. Adopted on 05/12/2012 (Doc. 2011/12)
Supplementary opinion on the approach and content of an envisaged proposal by the Commission on the
amendment of Directive 2004/37/EC on Carcinogens and Mutagens at the workplace. Adopted on 30/05/2013
(Doc. 727/13)
Supplementary opinion No. 2 on the approach and content of an envisaged proposal by the Commission on the
amendment of Directive 2004/37/EC on Carcinogens and Mutagens at the workplace. Adopted on 28/11/2013
(Doc. 2016/13)
The seminar report is available at https://osha.europa.eu/en/tools-and-publications/seminars/workshop-on-
carcinogens-and-work-related-cancer
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144
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9.2.6
Meetings with Industry and Workers representatives
Between the beginning of 2013 and end of 2015, a number of meetings between Commission
services and industry and workers representatives concerned about specific chemical agents
subject to the initiative took place, as well.
The following organisations, among others, discussed bilaterally with the Commission services
on specific chemical agents subject to the initiative:
NEPSi (European Network for Silica formed by the Employee and Employer European
sectoral associations),
Euromines and IMA (Industrial Minerals Association) for Silica;
ECFIA (European Ceramic Fibre Industry Association) and Unifrax for Refractory
Ceramic Fibers (RCF);
CEEMET (Council of European Employers of the Metal, Engineering and Technology-
Based Industries) and Eurometaux for metals as Chromium and Beryllium
BeST (Beryllium Science & Technology Association) for Beryllium.
The main purpose of the meetings asked for by industry was to achieve information on the
process for amending the legislation in general, and on the intention of the Commission with
regard to the proposed value for a particular chemical agent.
In particular with regard to RCS, the Commission discussed intensively possibilities to
recognise on the one hand the results of the NEPSi Agreement, and on the other hand to protect
also workers currently not covered by the agreement.
The Commission also participated in meetings organised annually by DG GROW with the
European Glass and Ceramic Industry, where similar information were presented.
Some conclusions can be drawn from these meetings regarding the position of the industry
representative organisations on specific substances.
For silica, the main concern for industry was the inclusion of the agent in Annex I of the CMD
but not the limit value itself, which is attainable in view of the current available technologies
and working methods. It was argued that the inclusion of the agent under the scope of the
Directive would put a more stringent obligation on substitution and process enclosure, leading to
non-affordable costs. It should however be noted that, where no workers were present (e.g. long
distance material conveyers), closed processes is not a CMD requirement – and that the
substitution principle already applies by means of the Chemical Agents Directive.
On Refractory Ceramic Fibres, the industry expressed their positive view on the establishment
of an EU-wide binding OEL as a way to demonstrate appropriate control of the exposure at the
workplace – potentially of value in discussions regarding REACH authorisation. The same
argument has been presented by the European metals industry as regards Hexavalent Chromium
compounds.
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10 A
NNEX
3 – W
HO IS AFFECTED BY THE INITIATIVE AND HOW
?
Who is affected
How
National authorities Given the substantial economic costs imposed on workers due to their
exposure to hazardous substances, the retained option also contributes to
mitigate financial loss of the Member State's social security system.
Member States must transpose the amended Directive into national
legislation:
- assessment of the national scenario and potential impacts
- design, if appropriate/needed, of special measures (eg., transitional
periods, exemptions, additional provisions for specific sectors,…)
- tripartite consultation of the proposal (workers, employers, authorities)
- facilitate implementation of the national legislation by providing,
among other measures, technical guidance to employers. These costs are
minor in comparison to the overall costs of functioning incurred by the
enforcement authorities.
- enforce the national legislation. Introduction of new OELs in the CMD
would not have any significant impact on the overall costs of the
inspection visits. Those are mostly planned independently of the revised
legislation. On the other hand, the existence of an OEL, by bringing
clarity regarding the acceptable levels of exposure, facilitates the work
of inspectors by providing a helpful tool for compliance checks.
The establishment of OELs at EU level eliminates the need for national
public authorities to independently evaluate each carcinogen thereby
removing an inefficiency of repetition of identical tasks.
Employers
As duty holders, employers must comply with the whole set of OSH
national legislation provisions. Given the nature of the proposed
amendment, this would mainly be:
- implementation of the necessary risk management measures (eg.,
substitution, local exhaust ventilation, closed systems, personal
protection equipment) in order to comply with the new or revised OELs
- implementation of a sampling strategy and airborne concentrations
measurement programme for the chemical agents with a new or revised
OEL, as part of the risk assessment process and effectiveness check of
the existing measures
- ensure that the chemical agents included in Annex I will be managed in
line with the provisions of the carcinogens and mutagens national
legislation
- ensure compliance with other provision in the legislation (specific
information and training to workers as regards the new working methods
if such is the need in order to comply with the new OELs, health
surveillance, if appropriate, for chemical agents now under the scope of
the legislation, collection of records, information to competent
authorities, etc).
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Most of the listed actions are, however, business as usual.
The benefits for employers include, inter alia, avoided loss of
productivity, simplification in ensuring legal compliance, improved
level playing field across the EU.
Workers
As protected subjects, workers would be positively affected by the
initiative in terms of a more effective protection of their health.
It is to be noted that workers have also the duty to comply with the
dispositions provided by the employers as regards the use of preventive
and protective measures necessary to comply with OSH legislation (.eg.,
the newly established OELs).
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11 A
NNEX
4 – A
NALYTICAL MODEL USED IN PREPARING THE
I
MPACT
A
SSESSMENT
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The impacts of the different policy options proposed in this impact assessment were quantified,
to the extent possible, based on a methodology as described below
147
.
11.1 Exposure estimation
The following occupational exposure information was required for each substance for estimating
the health impact of any changes in exposure:
-
-
-
-
Prevalence of exposure by industry (current);
Classification of industries into high, medium, low and background exposure, or a subset
of these categories;
Distribution of exposure (the geometric mean (GM) and geometric standard deviation
(GSD), ideally by country, across industries, and
Temporal change in exposure (% change per year) arising from general improvements in
European workplaces and work processes, not taking into account the impact of changes
to the Carcinogens Directive.
The graphic below provides an overview of the general procedure used for estimating the
prevalence of exposure:
Figure 1
Exposure prevalence data were available from the Carcinogens Exposure database (CAREX),
for almost all agents analysed in this impact assessment, except 1,2-Epoxypropane, 2-
Nitropropane and Hardwood Dust. For wood dust exposure, information on the prevalence (and
level) of exposure was available for 25 countries following an EU project estimating the risk of
exposure to wood dust (Kauppinen et al, 2005). For the remaining agents information collected
from trade associations and other stakeholders was used.
146
147
SHEcan report "Valuing health benefits"
The methodology was developed under the coordination of the Institute of Occupational Medecine in
collaboration with team members representing the following entities: the Imperial College of London; AMEC
Environment & Infrastructure UK Ltd; the Finish Institute of Occupational Health; IRAS, University of Utrecht;
IEH, Cranfield University.
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The information from CAREX and other sources, were combined with data from Eurostat
(number of workers exposed by relevant sector of activity) to obtain estimates of exposure
prevalence.
The level of intensity was assessed using:
-
-
-
-
Published scientific literature;
Information from European Risk Assessment Reports compiled in relation to the
Existing Substances Regulations;
The Woodex database (hardwood dust);
Information provided by industry stakeholders.
The overall weighted geometric mean (GM) and geometric standard deviation (GSD) exposure
level for each agent was estimated across all "medium" and "high" exposure industries across
the EU using @Risk (Palisade Corporation, New York).
Where possible, exposures were simulated using GM and GSD for each country. The number of
values each industry contributed was weighted according to the number of workers exposed in
that industry.
Temporal changes in exposure were determined from information from the literature, which was
ideally specific to the substance being considered but in situations where this was not available,
the study relied on the results of a systematic review of the literature (Creely et al, 2007).
11.2 Health impact – methodology for estimation of the current cancer burden (baseline)
as compared with the policy intervention scenarios
In order to assess the current burden of occupational cancer related to the exposure to substances
subject to this impact assessment, the analysis made was built on work to quantify the burden of
cancer due to occupation in Great Britain (Rushton at al, 2010).
The primary measure of the burden of cancer used in this project was the attributable fraction
(AF) i.e. the proportion of cases that would not occur in the absence of exposure; this was then
used to estimate the attributable numbers.
The estimates were made considering the risk exposure period (REP) for specific types of
cancer: for solid tumours a latency of 10-50 years was assumed and for haematopoietic
neoplasms 0-20 latency was assumed. The proportion of the population ever exposed to each
carcinogenic agent or occupation in the REP was obtained from the ratio of the numbers ever
exposed to the carcinogens of interest in each relevant industry/occupation over the total number
of people ever employed. Estimates of employment turnover for grouped main industry sectors
and of life expectancy were used to estimate the exposed population, and adjustment factors
were applied to the exposure prevalence data to take account of the change in numbers in the
industry sector groups.
The attributable fraction (AF) for each cancer/occupational carcinogen was estimated using
Levin's method (Levin, 1953).
The relative risk (RR) for cancer(s) in question for the relevant agent or work environments,
were derived from a review of the published epidemiological literature. Risk estimates were
obtained from key studies, meta-analyses or pooled studies, taking into account quality,
relevance to the EU, sample-size, effective control for confounders, adequate exposure
assessment, and clear case definition.
For predicting the future burden, the risk exposure windows were projected forward in time, and
estimation was carried out for a series of forecast target years (FTYs) that stretch far enough
into the future to account for the latency of cancers initiated at the time when the study was
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performed (i.e. the decade starting 2060). Estimates were made for alternative scenarios of
changes in exposure levels and proportions exposed, for example assuming the introduction of
new or reduced exposure limits, which were assumed introduced in 2010. The projections were
made each time under the assumption of full compliance with the legislation (i.e. 99% of
exposures less than the limit value).
To predict future cancer numbers based on the pattern of past and current exposure either a
"static" baseline, where no change in exposed numbers or exposure levels is expected beyond
2010, or a "dynamic" baseline was used, where current trends are forecast to continue until
2030.
The socioeconomic health impacts of the different policy options were then assessed in terms of
the cost of the disability and death based on the estimated cancer burden under each policy
option.
In this respect, several approaches exist to assessing potential health impacts ranging from non-
monetary approaches such as Quality Adjusted Life Years (QALY), Disability Adjusted Life
Years (DALY) and Health Life Years (HLY) to monetary methods such as the Cost of Illness
(COI), Value of Statistical Life (VSL) and Value of Life Year Lost (VLYL).
As part of this study, Imperial College have developed a model to estimate DALYs based on
exposure data from Institute of Occupational Medicine (IOM) and the Finish Institute for
Occupational Health. The DALYs uses time as a common metric taking into consideration both
premature death and ‘healthy’ years lost due to problems associated with living with the disease
or health condition (i.e. cancer for this study). DALYs are calculated as the sum of the years of
life lost due to premature mortality (YLL) and the years lost due to disability (YLD):
DALY = YLL + YLD
Each DALY represents one lost year of ‘healthy’ state. The DALYs can be used as one
approach to compare different options (e.g. cost effectiveness analysis) especially when
different Occupational Exposure Limit (OEL) values have been proposed. Entec have also used
the underlying data developed by Imperial College to attempt to monetise health impacts
associated with introducing EU-wide OELs. This will allow for a more formal cost benefit
analysis to be used to compare different policy options. This paper sets out this approach to
monetising human health impacts.
The approach used to estimate a monetary value on changes in health impacts is dependent on
the data available such as the population at risk (i.e. data on the exposed population) and any
evidence of dose-response relationships. Since it is not possible to develop dose-response
functions for each chemical agent, the approach to valuing changes in human health is based on
estimating the monetary loss (damages or costs) that might occur if no changes were made
(Business-As-Usual scenario) in comparison to the avoided health related costs under the
introduction of an EU-wide OEL level(s). The difference in health impacts between the BAU
scenario and the scenario(s) with an OEL is the main health benefits valued in this project.
The valuation of health impacts are divided into two main aspects:
Life years lost – This is calculated by using the year’s life lost (YLL) estimated by Imperial
College and multiplying this with a valuation of the Value of Life Year Lost (VLYL). This
values the time (years) lost due to premature death.
Cost of Illness (COI) – This is often the main market-based approach in relation to health impact
(ECHA 2008)
148
. Depending on the valuations available, it can include the direct, indirect and
148
(ECHA 2008) – Applying SEA as part of restriction proposals under REACH
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intangible costs of cancer. This is a monetary cost of the time spent with cancer. In this study, a
unit COI estimate is multiplied by the number of cancer registrations.
Each of these two impacts is explained in more detail below as well as using willingness-to-pay
(WTP) estimates as an alternative approach.
Value of life years lost (VLYL)
The years of life lost (YLL) are estimated by multiplying the number of disease specific deaths
times average life expectancy after average age at death from the specific disease
149
. EU and
Member State specific average life expectancies were used for this project. Essentially years of
life lost are the difference between death and average life expectancy (‘premature death’). This
is illustrated in Figure 2.
0
Full health
degree of
disability
YLL
1.0
now
death
max
(Average life
expectancy)
years
Figure
2
DALY component: Years of life lost (VLL)
Monetary estimates of the value of life years lost (YLYL or sometimes known as VOLY
150
)
allows us to put a value on VLL. The latest EC Impact Assessment guidance applicable at the
time of the study (EC 2009)
151
suggested using estimates of €50,000-100,000 in Europe for the
purpose of an Impact Assessment, if no more specific estimates are available. Markandya
(2003) uses an estimate of €50,000 and is also used more widely in other assessing health
policies such as CAFE. Therefore for the purposes of this study the €50,000 is used as a lower
estimate and €100,000 as an upper estimate. This should therefore help encompass the
uncertainties associated with the VLYL.
These valuations are increased by 2% each year in the future in part to present costs in real
terms (i.e. adjusting for inflation in prices) and to reflect societies increasing value attached to
their health (as economic growth typically increases over a long period of time).
The values originally reported in the IOM study, based on a constant discount rate of 4%, have
been recalculated applying a declining discount rate (4% for the first 20 years, 3% thereafter) in
line with the most recent EC Better Regulation guidelines
152
.
149
150
151
Data on disease specific deaths by age were not available so age weighting factors were not used.
Value of Life Years (VOLY)
EC (2015) Better Regulation Guidelines (19.5.2015).
http://ec.europa.eu/smart-regulation/guidelines/docs/swd_br_guidelines_en.pdf
This is consistent with some other European Commission studies and is standard practice for air quality under
the Clean Air for Europe (CAFE) programme.
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Cost of illness (COI)
Introduction
The cost of illness (COI) is one of the most common market based approaches to valuing health
impacts. It involves multiplying the number of cancer registrations occurring under each
scenario (i.e. with and without proposed changes) with the valuation for COI.
The COI might include health sector costs (direct costs), the value of lost productivity by the
patient (indirect cost), and the cost of pain and suffering (intangible costs)
153
. This will however
depend on data availability as in most cases intangible costs are unlikely to be included in
valuations of COI. These three components are described in Table 2.
Table
2
Components making up a valuation of COI
Components of the COI
Direct costs
Description
These include both the direct medical costs and direct non-medical costs of the disease:
Direct medical costs can include costs associated with the direct treatment of pain, including
analgesic medication, medical procedures and technology, hospitalisations, use of emergency
department services, and physician office visits for pain (Fortner et al. 2003)
154
.
Direct non-medical costs might include: transportation related expenses, childcare expenses,
household expenses, medicine expenses, household assistance, educational materials and
counselling or psychotherapy.
From a social perspective, it is also possible to divide the costs into costs borne by the health
service and those borne on the household:
Costs to the health Service – hospitalisation, medication, emergency (ambulance)
transportation and care, outpatient and primary clinic
Costs to the household - Out-of-pocket payments (user fees) for hospitals and drugs,
medication, transportation of the patient and family, costs for taking care of dependents and
modifications in home as a result of illness
Indirect costs
Indirect costs or productivity losses are the labour earnings that are forgone as a result of an
adverse health outcome. The decreased productivity can be a result of illness, death, side
effects, or time spent receiving treatment. Indirect costs include lost earnings and productivity
of both patients and the family members who take care of them. For some diseases with
premature death, the indirect cost is the loss in potential wages and benefits. Indirect costs
associated with premature death might be very high. Examples of indirect illness costs include
the value of time spent when unable to work as productively because of an illness or side
effect,
earnings lost while travelling to health-care facilities, and
productivity losses associated with caregiver time.
Intangible costs
The intangible cost components of illness are usually substantial, and in many cases, might
dominate the policy agenda. Examples include
disfigurement (e.g., breast cancer with surgery),
functional limitations (e.g., paralysis from polio),
pain (e.g., rheumatoid arthritis or bone metastasis), or
fear (e.g., HIV, rabies, or bovine spongiform encephalopathy [BSE]).
One approach to estimating the intangible costs is through willingness-to-pay (WTP) studies.
Source: Centers for Disease Control and Prevention – U.S. Department of Human Health & Services:
http://www.cdc.gov/owcd/eet/Cost/3.html#costofillness
153
154
http://www.cdc.gov/owcd/eet/Cost/3.html#costofillness
(Fortner et al. 2003) – “Description and Predictors of Direct and Indirect Costs of Pain Reported by Cancer
Patients” – Journal of Pain and Symptom Management – Volume 25. No 1 January 2003.
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Estimating COI
Outlined below is an approach to valuing COI for cancer (excluding intangible costs):
Cost of Illness
(COI)
Where:
Direct cost per
registration
Indirect cost per
registration
=
Direct outpatient
costs
+
Direct inpatient
costs
+
Direct homecare costs
Production lost
because of care-
giving
=
Number of cancer
registrations
x
(
Direct cost per
registration
+
Indirect cost per
registration
)
=
Value of production
x
(
Production lost
+
because of illness
)
It is extremely difficult to gather information required to estimate direct and indirect costs for
each type of cancer and estimate values of production and production lost for each sector
affected. In most cases, this information is not publicly available. Therefore, COI estimates
have been taken from existing studies related to cancer.
Rabl (2004)
155
provides values of unit costs (i.e. per patient) that are used in France for different
morbidity risks. It includes estimates for COI and willingness-to-pay (WTP) related to avoiding
the suffering and inconvenience of disease. The COI includes direct and indirect costs of cancer
but not the intangible costs of cancer. Intangible costs are however included in the WTP
estimates. These estimates are set out in Table 3.
Table 3. Estimated unit costs of cancer (€ 2009 prices) – except for NMSC
Health endpoint
Cancer, fatal (per incident)
Cancer, non-fatal (per incident)
Cost of Illness (COI)
€ 48,601
€ 48,601
WTP to avoid suffering
€ 1,768,256
€ 486,271
Note: Prices have been updated from USD to EUR using historical exchange rates for 2004 and updated to 2009 prices using the EU harmonised
index of consumer prices (HICP).
It was not possible to find an estimate for COI for each type of cancer and therefore the estimate
(€ 48,601) is used for all cancers, with the exception for nonmelanoma skin cancer (NMSC)
where there is a greater survival rate and costs of treatment may be less expensive.
Costs for NMSC are presented in Table 4. Costs for NMSC are based on a simple meta-analysis
of various studies examining the economic costs of NMSC. Of particular relevance was a study
by Miljoministeriet (2004)
156
in which the direct costs of NMSC and willingness to pay (WTP)
studies to avoid the permanent scars were reviewed. The study (along with other studies)
155
156
Rabl (2004) – “Valuation of Health End Points for Children and for Adults”, Working Paper.
Miljoministeriet (2004) - "Valuation of Chemical Related Health Impacts - Estimation of direct and indirect
costs for asthma bronchiale, headache, contact allergy, lung cancer and skin cancer" - Report prepared by COWI
A/S for the Danish Environmental Protection Agency http://www2.mst.dk/udgiv/publications/2004/87-7614-
295-7/pdf/87-7614-296-5.pdf
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suggests that NMSC can typically be treated within a year and is assumed, in general, to not
result in death.
The WTP to avoid scarring (249,424 DKK in 2002 prices) is taken from the Miljoministeriet
(2004) study and converted to Euros (€38,827 in 2009 prices) and is used as a high estimate.
The study also provides a possible low COI estimate of €2,926 (18,795 DKK in 2002 prices). A
comparable estimate is also derived from Morris et.al (2005)
157
which estimates COI at €2,601
in 2009 prices (based on an estimate of £1,413 in 2002 GBP prices). The latter is used as the
low estimate in the current analysis.
Another study by O'Dea (2009)
158
estimated the overall costs of NMSC to New Zealand. If
divided by the number of incidents, this gives a broad estimate of €538 per incident (867 NZD
in 2007/08 prices). However this was excluded as the per-registration costs was not explicitly
estimated and also may not necessarily be representative of costs for the EU.
Table 4 Summary of cost variables used for NMSC only (€ 2009 prices)
Cost/benefit elements
VLYL - Each year lost
COI or WTP - Unit cost (per cancer registration)
Low scenario
€ 50,393
€ 2,601
High scenario
€ 50,393
€ 38,827 (WTP)
Note: As the WTP to estimate relates to not having permanent scars and does not include the costs associated with life years lost, the high
scenario also incorporates the impacts of any life years lost. This differs from the approach used for other types of cancer whereby the WTP
already includes life years lost (and is therefore excluded to avoid double counting benefits).
There are relatively few alternative monetised estimates of COI for cancer in existing literature
and therefore it is very different to understand how representative these costs are for the rest of
Europe. Fortner et al. (2003) estimates the mean monthly direct medical and non-medical pain
related costs per patient (in the US) at around $891 (~$10k p.a.), with a maximum cost of $20k
per month. Rabl’s actual unit estimate of $54,970 (2004 USD price) would seem an appropriate
estimate for cancer treatment in the EU for this project, when taking into consideration the
typical times spent in cancer stages related to treatment.
As part of the calculations to estimate the years lived with disability (YLD), Imperial College
needed to estimate the mean duration spent in each cancer stage for each disease. The names
and number of stages presented in blue in Figure 4. may differ in existing literature, but the
increased segregation allows us to better assign time that may be spent in each cancer stage.
157
Morris et.al (2005) - "cost of skin cancer in England" - Report by S. Morris, B. Cox and N. Bosanquet for
Tanker
Business
School,
Imperial
College
London
-
http://www3.imperial.ac.uk/pls/portallive/docs/1/43013.PDF
O'Dea (2009) - "The estimated costs - economic and human - of skin cancers in New Zealand" -
http://www.niwa.co.nz/?a=103433
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Registered with
cancer
State after
intentionally
curative primary
therapy
Cure
Survivor with long
term sequelae
Diagnosis and
primary therapy
In remission
Disseminated /
metastasis stage
Terminal stage
Death
(premature)
Figure
4
. Cancer stages
The SHEcan health impact assessment has estimated the duration of time spent a patient may
spend in each cancer stage and what proportion survive and die prematurely from cancer. The
time spent in diagnosis and primary therapy is particularly relevant for assessing the costs of
treatment. The time spent varies significantly with each type of cancer, ranging from 2 weeks
for Non-Melanoma Skin Cancer (NMSC) to up to 18 months for leukaemia.
Taking into consideration that Fortner et al’s mean estimate (~$10k p.a.), does not include
indirect costs due to a loss of productivity, it is reasonable to assume that the updated Rabl
estimate (€ 48,601) is suitable for the purposes of this study in the absence of further COI
estimates for cancer. As with the estimate of VLYL, the COI unit cost is increased by 2% each
year to account for inflation and discounted using a 4% discount rate and using a declining
discount rate (for impacts occurring after 30 years). For sensitivity analysis, the discount rate is
changed; using a declining discount rate and no discounting is also considered.
Willingness to pay (WTP)
An alternative to COI is Willingness-to-pay (WTP). WTP typically includes
159
(1)
(2)
(3)
(4)
Lost wages
160
;
Medical expenses;
The monetary value of the disutility of illness; and
The impact of preventive expenditures.
The WTP estimates reflect what people are willing to pay to avoid the having cancer (both fatal
and non fatal). These estimates also include intangible costs which are very difficult to value
within COI estimates (i.e. 3 and 4). As shown in Table 3. WTP costs are significantly higher
than the COI estimates which only estimate those impacts which can be calculated using market
prices. It has been suggested that the COI can be used as a lower bound to WTP estimates. For
the purposes of this study, the low benefits scenario is estimated using COI + YLYL and the
high scenario using WTP only. The reader can make their own judgement on either COI should
be viewed as a lower bound to the WTP results.
159
160
See: http://www.ers.usda.gov/publications/aer784/aer784f.pdf
In some instances with premature death, this term drops out the calculations of WTP unless a bequeath motive is
specified
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In order to use the estimate for the WTP to avoid suffering under each scenario, it is necessary
to be able to split cancer registrations to those that result in fatalities (premature death) and those
which result in non fatal cancers. It is however very difficult to make this split without making
critical assumptions, since most studies are based on cancer survival times in intervals of 1, 5
and 10 years rather than fatal and non-fatal cancers. It is not possible for this study, to
determine (with sufficient confidence) what proportion of cancer registrations will be fatal and
non-fatal. Since WTP is used as a high cost scenario, the WTP estimate for fatal cancers is used
(€1.8m). Since NMSC is not considered to necessarily be fatal a lower WTP is used (€38,827).
It is recognised in reality, that the average proportion of cancer registrations being fatal or non-
fatal may vary depending on several factors such as; the type, size and spread of the cancer (e.g.
can vary depending on if the cancer has been identified at an early or late stage) and the patient
itself; age, gender, general health, marital status and income level. However the range of costs in
the low and high scenarios might provide a useful comparison to the reader.
Summary – values used in this study
The tables below summarise the cost variables used in the study. Table 5. summaries the costs
variables used in this study for all types of cancer, with the exception for nonmelanoma skin
cancer (NMSC) where there is a greater survival rate and costs of treatment may be less
expensive. The costs specifically for NMSC are summarised in Table 6.
Table
5
. Summary of cost variables used in this study for all cancers except NMSC (€ 2009 prices)
Cost/benefit elements
VLYL - Each year lost
COI or WTP - Unit cost (per cancer registration)
Low scenario
€ 50,393
€ 49,302 (COI)
High scenario
€ 0 (note 1)
€ 1,793,776 (WTP)
(Note 1) – By using WTP (€1.8m) in the high scenario instead of COI, the WTP can include the costs of premature death and therefore there was
a risk of double counting benefits if VLYL costs were included.
Table 6.
Summary of cost variables used for NMSC only (€ 2009 prices)
Cost/benefit elements
VLYL - Each year lost
COI or WTP - Unit cost (per cancer registration)
Low scenario
€ 50,393
€ 2,601
High scenario
€ 50,393
€ 38,827 (WTP)
Note: As the WTP to estimate relates to not having permanent scars and does not include the costs associated with life years lost, the high
scenario also incorporates the impacts of any life years lost. This differs from the approach used for other types of cancer whereby the WTP
already includes life years lost (and is therefore excluded to avoid double counting benefits).
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11.3 Compliance costs
In order to assess the compliance costs of meeting the proposed amendments to the Directive,
particularly the introduction of a limit value, the main uses leading to exposures that are a risk to
human health were identified. Minor uses were considered but not assessed.
Consideration was given to possible risk management measures (RMM) that may be applied in
order to meet the investigated OEL and whether these RMMs may have already been applied -
in some countries or all EU countries. Background information on all agents in the project was
obtained from published literature and stakeholder contacts to identify:
- the uses and activities that lead to workplace exposure risks to human health;
- the structure of the sectors in which exposure occurs;
- exposure control measures currently in place, available and required to meet the proposed OEL
and
- the possible costs of exposure control measures.
In order to understand the economic impacts on sectors in which specific uses cause a risk to the
health of workers, the contractor has used Eurostat data about the number of enterprises
operating in different sectors, the number of enterprises in the EU, and financial measures such
as turnover, personnel costs and research and development expenditure.
Estimates were made of:
- the number of firms needing to apply RMMs and the cost of the RMMs over the same time
period as health benefits (2010-2069);
- the cost of the administrative procedures of implementing the OEL (e.g. the cost of monitoring
and audit);
- the potential effect on the market for the substance by the imposition of the OEL – i.e. the
change in the market for the substance as a result of increased cost of control – leading to
adoption of substitutes and possible change in price of the substance itself.
The final analysis comprises a comparison of the costs and benefits of the 'baseline (do nothing)'
option with the scenario in which the possible OEL is added to the CMD Directive over the
analysis time frame i.e. 2010-2069.
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12 A
NNEX
5 –
AGENTS
DETAILED
I
NFORMATION
ON THE CARCINOGENICITY OF THE CHEMICAL
The table below summarises the current situation as regards the availability of SCOEL
Recommendations for the 13 chemical agents in question.
Table 1. Current situation regarding SCOEL Recommendations for chemical agents in the present proposal.
CLP
Harmonised
Class.
Respirable crystalline silica N/A
Refractory ceramic fibres 1B
(RCF)
Acrylamide
1B
Vinyl chloride monomer 1B
(VCM)
Hardwood dust, as
N/A
inhalable dust
Chrome (VI) compounds 1B
1,3 Butadiene
1A
Ethylene oxide
1B
1,2 Epoxypropane
1B
o-Toluidine
1B
Chemical Agent
IARC SCOEL
Year
Class. Recommendation
1
2B
2A
1
1
1
1
1
2B
1
SCOEL SUM 94 2003
SCOEL SUM 165 2011
SCOEL SUM 139 2010
SCOEL SUM 109 2004
SCOEL SUM 102 2003
SCOEL SUM 86
SCOEL SUM 75
SCOEL SUM 160
SCOEL SUM 161
No SCOEL
Recommendation
2004
2007
2012
2010
IOM Study considered potential
OELs of 0.1 ppm (0.4 mg/m
3
)
and 1 ppm (4.4 mg/m
3
) as
'typical' values of existing
national OELs in the EU.
IOM Study considered 0.5 ppm
(19 mg/m
3
) for assessment, as
'typical' values for existing
national OELs in the EU.
Comments
2 Nitropropane
1B
2B
No SCOEL
Recommendation
Bromoethylene
Hydrazine
1B
1B
2A
2B
SCOEL SUM 155 2008
SCOEL SUM 164 2010
12.1 Respirable crystalline silica
12.1.1 Identification
Index Number:
EC Number:
CAS Number:
none
none
14808-60-7 (Quartz)
14464-46-1 (cristobalite)
15468-32-3 (tridymite)
Silica (silicon dioxide (SiO
2
)), occurs in either a crystalline or non-crystalline (amorphous)
form. Crystalline silica may be found in more than one form (polymorphism), depending on the
orientation and position of the tetrahedra (i.e., the three-dimensional basic unit of all forms of
crystalline silica). The natural crystalline forms of silica are α-quartz, α-,β
1
-, and β
2
-tridymite, α-
and β-cristobalite, coesite, stishovite, and moganite (IARC, 1997). The most common form of
naturally occurring crystalline silica are quartz (CAS No. 14808-60-7), Cristobalite (CAS No.
14464-46-1) and tridymite (CAS No. 15468-32-3), but they can also be created during industrial
processes, such as the calcination of diatomaceous earth, ceramics manufacturing, foundry
processes, silicon carbide manufacturing, and any other process in which quartz is heated to
high temperature.
12.1.2 Synonyms
silicon dioxide, crystalline
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12.1.3 Classification according to Regulation (EC) N° 1272/2008 with regard to
carcinogenicity
161
:
None.
It should be noted that the polymorphs' of silica which comprise RCS are commonly placed on
the market and are subject to CLP classification.
The three most common 'polymorphs' of crystalline silica are quartz, cristobalite, and tridymite
– all of which have been self-classified by suppliers in the EU. These classifications have been
notified to the European Chemicals Agency for inclusion in the Classification and Labelling
Inventory (CLI).
Self-classifiers are not bound to adopt any particular classifications and are free to classify their
products differently from one another. CLI entries for quartz and cristobalite include some
classifications for category 1 carcinogenicity although the majority of the notifications only
concerns Specific Target Organ Toxicity (STOT) and according to some notifications the
substance is not classified. CLI entries for tridymite do not include classifications for
carcinogenicity. The substance has not been classified as hazardous according to CLP.
12.1.4 Classification according to IARC
162
The International Agency for Research on Cancer (IARC) has stated its opinion that 'crystalline
silica inhaled in the form of quartz or cristobalite from occupational sources is carcinogenic to
humans (Group 1)' (IARC Monograph 68).
In making its overall evaluation the IARC Working Group noted that carcinogenicity in humans
was not detected in all industrial circumstances studied, and that carcinogenicity may be
dependent on inherent characteristics of the crystalline silica, or on external factors affecting its
biological activity or distribution of its polymorphs.
There is more recent information on the carcinogenicity of RCS in the IARC monograph
volume 100C on arsenic, metals, fibres and dusts. This was published in 2012 and represents the
views and expert opinions of the IARC Working Group on the Evaluation of Carcinogenic Risks
to Humans which met in Lyon, 17 – 24 March 2009. The conclusions of the IARC Monograph
100C confirm, based on more recent scientific evidence, that crystalline silica in the form of
quartz or cristobalite dust is carcinogenic to humans (Group 1).
12.1.5 Recommendation of SCOEL
163
The main effect in human of the inhalation of respirable silica dust is silicosis. There is
sufficient information to conclude that the relative lung cancer risk is increased in persons with
silicosis (and, apparently, not in employees without silicosis exposed to silica dust in quarries
and in the ceramic industry). Therefore, preventing the onset of silicosis will also reduce the
cancer risk. Since a clear threshold for silicosis development cannot be identified, any reduction
of exposure will reduce the risk of silicosis.
It was observed that the dose-response curve for silicosis appears to be sigmoidal and that
maintenance of exposure below 0.05 mg/m
3
would avoid being on the steeper part of the dose-
161
The majority of the chemical agents subject to this initiative are not only classified as carcinogens but also for
other adverse health effect. Because the other effects are of less importance for the initiative as such, additional
classifications for other adverse health effects are not mentioned here
http://monographs.iarc.fr/ENG/Monographs/vol100C/mono100C-14.pdf and
http://monographs.iarc.fr/ENG/Monographs/vol1-42/mono42.pdf and
http://monographs.iarc.fr/ENG/Monographs/vol68/mono68-6.pdf
Recommendation from the Scientific Committee on Occupational Exposure Limits for Silica, Crystalline
(respirable dust); SCOEL/SUM/94, November 2003
111
162
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response curve, in the region where relatively small increases in exposure entail significant
increases in silicosis risk.
The reduction of exposure to 0.05 mg/m
3
of crystalline silica is expected to reduce the
prevalence of silicosis, ILO category 1/1, to about or less than 5% whereas an average respirable
silica concentration of 0.02 mg/m
3
reduces prevalence of silicosis to about 0.25 % or less.
It arises that an OEL should lie below 0.05 mg/m
3
of respirable silica dust.
No STEL or skin notation are needed.
12.2 Refractory ceramic fibres (RCFs)
12.2.1 Identification
Index Number
164
:
EC Number
165
:
CAS Number
166
:
12.2.2 Synonyms
The complete name of the chemical agent classified according to the CLP Regulation is
"Refractory ceramic fibres with the exception of those species elsewhere in Annex VI to
Regulation (EC) 1272/2008 [Man-made vitreous (silicate) fibres with random orientation with
alkaline oxide and alkali earth oxide (Na
2
O+K
2
O+CaO+ MgO+BaO) content less or equal to
18 % by weight]
Vitreous siliceous fibres, alumino-silicate glass wools
12.2.3 Classification according to Regulation (EC) N° 1272/2008 with regard to
carcinogenicity
Carc. 1B – Causes Cancer by Inhalation
650-017-00-8
-
142844-00-6
164
Entries in Part 3 of Regulation (EC) N° 1272/2008 of the Regulation of the European Parliament and of the
Council on the classification, labelling and packaging of chemical agents and mixtures are listed according to the
atomic number of the element most characteristic of the properties of the chemical agent. Organic chemical
agents, because of their variety, have been placed in classes. The Index number for each chemical agent is in the
form of a digit sequence of the type ABC-RST-VW-Y. ABC corresponds to the atomic number of the most
characteristic element or the most characteristic organic group in the molecule. RST is the consecutive number
of the chemical agent in the series ABC. VW denotes the form in which the chemical agent is produced or placed
on the market. Y is the check-digit calculated in accordance with the 10-digit ISBN method. This number is
indicated in the column entitled "Index No".
The EC number, i.e. EINECS, ELINCS or NLP, is the official number of the chemical agent within the European
Union. The EINECS number can be obtained from the European Inventory of Existing Commercial Chemical
Chemical agent (EINECS)[1]. The ELINCS number can be obtained from the European List of Notified
Chemical agents (as amended) (EUR 22543 EN, Office for Official Publications of the European Communities,
2006, ISSN 1018-5593). The NLP number can be obtained from the list of 'no-longer polymers' (as amended)
(Document, Office for Official Publications of the European Communities, 1997, ISBN 92-827-8995-0). The EC
number is a seven-digit system of the type XXX-XXX-X which starts at 200-001-8 (EINECS), at 400-010-9
(ELINCS) and at 500-001-0 (NLP). This number is indicated in the column entitled 'EC No'.
The Chemical Abstracts Service (CAS) provides a system whereby chemical agents are added to the CAS
Registry and are assigned a unique CAS Registry Number. Those CAS numbers are used in reference works,
databases, and regulatory compliance documents throughout the world to identify chemical agents without the
ambiguity of chemical nomenclature
112
165
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12.2.4 Classification according to IARC
167
Group 2B – The agent is possibly carcinogenic to humans
12.2.5 Recommendation of SCOEL
168
Occupational exposure to RCFs is associated with adverse respiratory effects as well as skin and
eye irritation and may pose a carcinogenic risk based on the results of chronic animal inhalation
studies. In these studies, exposure to RCFs produced an increased incidence of mesotheliomas
in hamsters and lung cancer in rats. Mesotheliomas and sarcomas in rats and hamsters have also
been induced after intrapleural and intraperitoneal implantation of RCFs. Intratracheal
instillation induced lung tumours in rats.
Epidemiologic studies have found no association between occupational exposure to airborne
RCFs and an excess rate of pulmonary fibrosis or lung cancer.
The epidemiological studies in the US and in Europe showed an association between exposure
and increased prevalence of respiratory symptoms and conditions such as dyspnoea, wheezing,
chronic cough, decreases in pulmonary function, and skin, eye, and upper respiratory tract
irritation. These findings, which primarily reflect workers employed before 1980, did not persist
with analysis of follow-up production years and accumulated RCF exposure from initial
pulmonary function tests. More recent exposures from the late 1980s until 2004 had no
deleterious impact on the longitudinal trend of FVC
169
and FEV1
170
. During this time the RCF
workplace concentrations constantly decreased below 1 f/ml. Since about 1993 the
concentrations ranged around 0.2 f/ml in RCF fibre manufacture facilities and decreased from
about 0.4 to 0.3 f/ml in customer facilities
171
. So far none of these studies provide information at
what concentration the pulmonary effects are no longer seen. The common presence of other
non-fibrous dust further complicates the evaluation of effects and their dose-responses at
specific RCF workplace exposures. However, the studies indicate that the exposures since the
late 1980s neither had deleterious impact on the lung function, nor diagnosed pleural plaques or
mesothelioma. These exposures ranged from approximately 1 fibre/ml to below the limit of
detection (Rice et al 1997)
172
.
Pulmonary function provides sensitive parameters to evaluate the effects of RCF exposure (see
studies in workers in the US: Lockey et al., 1998, 2002; LeMasters et al., 1998; McKay 2010).
The first cross-sectional pulmonary function study reported statistically (but not clinically)
significant decrements in FVC and FEV1 for workers in the highest exposure category (> 60
fibres-months per cc) compared to those in the lowest exposure category (≤15 f-m/cc), but later
studies reported no significant decline in lung function in a longitudinal analysis of male
workers providing pulmonary function tests over seven years.
Upon request the authors of the McKay et al. (2010) study provided the following additional
information:
167
http://monographs.iarc.fr/ENG/Monographs/vol81/mono81.pdf and
http://monographs.iarc.fr/ENG/Publications/techrep42/TR42-6.pdf
Recommendation from the Scientific Committee on Occupational Exposure Limits for Refractory Ceramic
Fibres SCOEL/SUM/165 September 2011
Force Vital Capacity is the total amount of air exhaled during the FEV test.
Forced expiratory volume measures how much air a person can exhale during a forced breath. The amount of air
exhaled may be measured during the first (FEV1), second (FEV2), and/or third seconds (FEV3) of the forced
breath.
A figure illustrating this trend can be found in the above mentioned SCOEL document on page 14
Rice D, Lockey J, Lemasters G, Levin L, Staley P, Hansen KR (1997) Estimation of historical and current
employee exposure to refractory ceramic fibers during manufacturing and related operations. Appl Occup
Environ Hyg 12, 54-61
113
168
169
170
171
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• The average cumulative exposure among all workers in the > 60 f-mo/ml group was 147.9 f-
mo/ml, and
• When sorted by chronological age, those workers at age 60 in the > 60 f-mo/ml group
experienced an average cumulative exposure of 184.8 f-mo/ml.
Assuming a 45 years exposure the average cumulative exposures of 147.9 and 184.8 f-mo/ml,
respectively, result in an average fibre concentrations of 0.27 and 0.34 f/ml. Considering these
values as no observed adverse effect levels SCOEL proposes an OEL of 0.3 f/ml.
From the available information it is concluded that the genotoxic effects observed in the
different studies are secondary so that RCFs are classified as SCOEL Carcinogen group C
carcinogens: Genotoxic carcinogens for which a practical threshold is supported.
12.3 Acrylamide
12.3.1 Identification
Index Number:
EC Number:
CAS Number:
12.3.2 Synonyms
2-propenamide, acryl acid amide, ethylene caroxamide, propenoic acid amide, vinyl amide
12.3.3 Classification according to Regulation (EC) N° 1272/2008 with regard to
carcinogenicity:
Carc. 1B – may cause cancer
12.3.4 Classification according to IARC
173
Group 2 A – The agent is probably carcinogenic to humans
12.3.5 Recommendation of SCOEL
174
As evidenced in animal experiments, acrylamide possesses a number of hazardous properties
including neurotoxicity, impairment of male fertility, somatic and germ cell mutagenicity, and
carcinogenicity. In relation to neurotoxicity, acrylamide causes impairment of axonal transport,
leading to axonal swelling, loss of axons, degenerating myelin and changes to glial cells in the
brain, spinal cord and peripheral nervous system. In workers, exposures to acrylamide have led
to clinical signs of neurotoxicity such as tremor, in-coordination and reductions in nerve
conduction velocity, and symptoms such as tingling and numbness in the hands and feet.
There are reports of skin irritation with an unusual presentation, i.e peeling of the skin on the
hands and feet.
Rodent carcinogenicity studies in which acrylamide was administered in the drinking water
showed increased tumour incidences in a number of organs/tissues including the testicular
mesothelium, adrenals, mammary glands, and thyroid. This tumour profile suggests that the
mechanism of carcinogenesis may involve hormonal disturbance but there is no definitive
evidence for endocrine disturbance that could account for the diverse range of tumours seen.
The fact that acrylamide does not affect fertility in females does not add support to a proposed
hormonal mechanism for tumour development. It is also noted that there is evidence suggestive
173
174
616-003-00-0
201-173-7
79-06-1
http://monographs.iarc.fr/ENG/Monographs/vol60/mono60-16.pdf
Recommendation from the Scientific Committee on Occupational Exposure Limits for Acrylamide,
SCOEL/SUM/139, September 2011, Annex December 2012
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of an increase in glial cell tumours in the brain and spinal cord. In view of the genotoxic
properties of acrylamide, a role for genotoxicity cannot be excluded.
In relation to the evidence for carcinogenicity in humans, there are two cohort studies in
workers, and a number of studies of dietary exposure in the general population. None of these
studies reveal any link between acrylamide and cancer, but there are possible limitations in these
studies (low cumulative exposures in the occupational studies and the possibility of exposure
misclassification in the dietary studies). Overall, in view of the animal evidence for
carcinogenicity, as well as the evidence for somatic and germ cell mutagenicity, there has to be
a concern for carcinogenic potential in humans and concern for the possibility of heritable
mutations. A clear threshold for such effects cannot be identified. The very clearcut and strong
neurotoxicty of acrylamide has led to an avoidance of higher exposures in industrial practice
also in the past. Therefore, it is plausible why no direct evidence for acrylamide in exposed
humans has been obtained.
The uncertainties surrounding the risk of cancer and genotoxicity (in particular heritable
mutations) in workers exposed to acrylamide suggest that a health-based OEL cannot be
derived. Although attempts have been published to explain the modes of action of the various
tumour types observed in experimental animals (Shipp et al. 2006), the multiplicity of target
sites, combined with the directly genotoxic nature of the metabolic intermediate, glycidamide,
add significant uncertainties to these explanations (see also the detailed discussion by DFG
2007, 2009). Considering this situation, acrylamide is categorized in the SCOEL carcinogen
group B (Bolt and Huici-Montagud 2008), as a genotoxic carcinogen, for which the existence of
a threshold cannot be sufficiently supported at present. In consequence, a health-based OEL and
BLV cannot be recommended.
A reasonable quantitative cancer risk assessment for humans is not feasible for acrylamide,
because of two reasons: (1) Human cancer studies do not provide reliable figures as a basis of a
risk quantitation. (2) The cancers observed in rats (testicular mesotheliomas, mammary tumours,
glial cell tumours, thyroid tumours, adrenal phaeochromocytomas) are significantly influenced
by species-specific factors, which make meaningful quantitative extrapolations to humans
almost impossible.
However, it is important that any regulation that may be established for acrylamide should also
be protective against the development of neurotoxicity, given that there is a wealth of evidence
for acrylamide-induced neurotoxicity in workers.
Experimentally, a minimal effect level (LOAEL) for neurotoxicity of 1 mg/kg per day and a
NOAEL at the next lower dose of 0.2 mg/kg/day was established in a 90-day drinking water
study in rats (Burek et al 1980). Johnson et al. (1984, 1986) repeated this study as part of a
chronic study with a dose of 0.5 mg/kg per day and found no effect. Both studies included
electron microscopic examinations. Hence, an established NOAEL for neurotoxicity in the rats
is 0.5 mg/kg. This would correspond, for the rat (8 h respiratory volume of 0.38 m
3
/kg) to an
inhalation concentration of 1.32 mg.m
-3
, i.e. 0.45 ppm (8-hr TWA).
In occupational studies it is difficult to establish a dose-response for neurotoxicity due to the
inability to distinguish the relative contributions of dermal and inhalation exposure. However, a
dose-response between neurological symptoms and acrylamide-haemoglobin adducts was
reported in a study in tunnel workers (Hagmar et al 2001). The workers in this study were
mainly exposed to acrylamide via dermal contact. By using biological monitoring of the
haemoglobin adduct of acrylamide (N-2-carbamoyl-ethyl-valine), a NOAEL for neurotoxicity of
0.5 nmol adduct/g globin was reported with respect to neurotoxicity in occupationally exposed
persons. This is seconded by another notion that no symptoms of peripheral neuropathy were
reported in workers with this same adduct level in a biological monitoring study (Jones et al
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2006). The adduct level based on these studies of 0.5 nmol/g globin would correspond to an
airborne exposure of about 0.1 mg.m
-3
or 0.035 ppm (8-hour TWA).
Dermal absorption is important in relation to workers under practical working conditions, and a
‘skin’ notation is therefore warranted. Indeed, in view of the low volatility of acrylamide there is
the possibility that the skin is the dominant exposure route.
An Annex on possibilities for biological monitoring of occupational exposures to acrylamide
was produced by SCOEL in December 2012.
12.4 Vinyl chloride monomer
12.4.1 Identification
Index Number:
EC Number:
CAS Number:
12.4.2 Synonyms:
VCM, chloroethylene
12.4.3 Classification according to Regulation (EC) N° 1272/2008 with regard to
carcinogenicity:
Carc. 1A – May cause cancer
12.4.4 Classification according to IARC
175
Group 1 - The agent is carcinogenic to humans
12.4.5 Conclusions of SCOEL
176
Vinyl chloride is an established carcinogen, both in humans and in experimental animals. The
primary target of its carcinogenicity is the liver, although there is clear experimental and
suggestive human evidence that it also acts at extrahepatic sites. The primary, and most typical,
liver tumour is angiosarcoma (hemangioepithelioma), but experimental data also demonstrate
formation of hepatocellular carcinomas.
The SCOEL was asked to perform an assessment of human risk of carcinogenicity, related to
workplace conditions. As a first step, available data were reviewed, which indicated that a linear
high dose–low dose extrapolation of tumour risk was the most appropriate way in this case.
On this basis, the available quantitative risk assessments were reviewed, including those based
on human epidemiological data and those based on extrapolation from animal data, by means of
PBPK modelling.
The different approaches resulted in final risk estimates which were basically consistent with
one another. As a result, it was inferred from epidemiological studies that a continuous exposure
for working life (estimated to be 14% of the total lifetime) to
1 ppm vinyl chloride would be
associated with a cancer risk for hepatic angiosarcoma of about 0.3 x 10
-3
.
Independent data, derived from animal experiments and using PBPK modelling, point to a
similar order of magnitude (between 0.2 and 1.6 x 10
-3
), and thus confirm this approach.
602-023-00-7
200-831-0
75-01-4
175
http://monographs.iarc.fr/ENG/Monographs/vol97/mono97-8.pdf and
http://monographs.iarc.fr/ENG/Monographs/vol100F/mono100F-31.pdf
Recommendation from the Scientific Committee on Occupational exposure Limits, Risk Assessment for Vinyl
Chloride, SCOEL/SUM/109 final, November 2004
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12.5 Hardwood dust
12.5.1 Identification
Index Number:
EC Number:
CAS Number:
none
none
none
12.5.2 Classification according to Regulation (EC) N° 1272/2008 with regard to
carcinogenicity:
none
12.5.3 Synonyms
12.5.4 Classification according to IARC
177
Group 1 - The agent is carcinogenic to humans
12.5.5 Recommendations of SCOEL
178
Exposure to wood dust was shown to be associated with an increase of sino-nasal cancers,
though this is a rare cancer. Impairment of respiratory function and increased prevalence of
pulmonary symptoms were also observed in humans after exposure to wood dust.
Distinction between softwoods and hardwoods
As regards the risk of
sino-nasal cancer,
it seems that hardwood dusts are particularly
dangerous, as they are probably also more dangerous than softwood dusts with respect to
adenocarcinomas. However, as has already been stressed, it is impossible at the moment for two
essential reasons to clearly identify the particular role of each type of wood in the genesis of
cancer: (i) too few studies have addressed this problem and (ii) both types of wood are usually
used in most wood-related fields of activity and workers have been exposed to both of them.
As regards the risk of
non-carcinogenic effects on the respiratory tracts,
practically all types
of wood can cause various pulmonary symptoms in exposed workers, although only some, red
cedar in particular, have been studied in any detail. However, the large number of studies
involving red cedar should not be taken to imply that the dust of this species is the only one
responsible for asthma and non-allergic affections of pulmonary function. It is very probable
that similar results for respiratory effects due to the dusts of other wood species would be found
if they had been studied in sufficient detail. This is suggested by the numerous descriptions of
asthma cases related to occupational exposure to dust from many types of wood.
Irrespective of their already emphasised inadequacies, the results of experimental studies in
animals provide no conclusive argument to justify a distinction between effects specific to
softwood dusts and other effects specific to hardwood dusts.
With regard to currently available data and with a view to protecting the health of workers, all in
all it does not seem pertinent to distinguish between softwood and hardwood dusts.
Particle size considerations
In the last decade, the rationale for sampling particle sizes relevant to expected health effects has
gained recognition with the adoption of health-related aerosol size fraction definitions by the
International Organization for Standardization
(IOS, 1991), the
American Conference of
Governmental Industrial Hygienists
(ACGIH, 2000) and the
Comité Européen de Normalisation
177
http://monographs.iarc.fr/ENG/Monographs/vol62/mono62-6.pdf and
http://monographs.iarc.fr/ENG/Monographs/vol100C/mono100C-15.pdf
Recommendation from the Scientific Committee on Occupational Exposure Limits: Risk assessment for Wood
dust, SCOEL/SUM/102 final, December 2003
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(CEN). Three particle size distributions relevant to different capture areas of the human
respiratory tract are distinguished: inhalable (any particles which enter the nose and mouth; 50%
capture of 100 µm aerodynamic diameter particles); thoracic (particles which pass the larynx;
50% capture of 10 µm particles) and respirable (or alveolar: particles which enter the alveolar
region; 50% capture of 4 µm particles). Occupational exposure standards specifically indicating
these dust fractions should have two major advantages: reducing the variability due to
fluctuations in the size distributions sampled and targeting the appropriate risk factors for wood
dust-related disease.
However, most epidemiological studies have not assessed exposure-response relationships using
particle size-selective measurements.
Considerable uncertainties exist to establish valid conversion ratios from total dust (as measured
by the equipment used for most epidemiological studies), to an inhalable dust level, which is the
most appropriate size fraction for the mass effects of exposure to wood dust. However, the
available data suggest that a numerical value of an OEL expressed as "inhalable dust" may be
set at approximately twice the numerical value for the corresponding limit value for "total
dust"
179
.
The mechanism underlying carcinogenesis by wood dust has not yet been elucidated. The few
positive results in genotoxicity tests were obtained mainly with extracts of woods. The
hypothesis of physico-mechanical cancer induction has not been clearly demonstrated by
experiments.
The studies available do not provide adequate information for setting a health-based limit value
for the protection of workers exposed to wood dust.
Taking into account the uncertainties and limitations of the available studies, it can be stated that
exposure above 0.5 mg/m
3
induces pulmonary effects and should be avoided. Exposure levels
lower than 0.5 mg/m
3
were associated with the induction of bronchial asthma only when the
exposure was to western red cedar dust. The level of 0.5 mg/m
3
(total dust) and 1 mg/m
3
(inhalable dust) is probably below the levels to which the cases of sino-nasal cancers had been
exposed.
12.6 Chromium (VI) compounds
12.6.1 Identification
Major factors governing the toxicity of chromium compounds are oxidation state and
solubility.
180
Chromium (VI) compounds – also known as hexavalent chromium compounds –
which are powerful oxidizing agents, appear to be much more toxic systemically than
Chromium (III) compounds given similar amounts and solubility
181
.
Chromates and dichromates exist as a wide variety of compounds with 20 to 30 being of major
industrial importance. These include, ammonium chromate and dichromate, barium chromate,
calcium chromate and dihydrate, chromic chromate, chromium (IV) chloride, chromium trioxide
(chromic
acid),
chromyl
chloride,
lead
chromates,
molybdenum
orange
179
180
Further information on this topic is provided in an Annex to the above mentioned SCOEL document.
The solubility of chromates varies widely and ranges from virtually insoluble to highly soluble. The various uses
of the term solubility have caused much confusion and to harmonise discussions and classification it has been
proposed (Cross
et al,
1997) that the water solubility of hexavalent chromium compounds can be defined as:
poorly soluble (<1g/l), sparingly soluble (1-10g/l); highly soluble (>100g/l). Thus, poorly soluble includes lead
and barium chromate, sparingly soluble includes strontium, calcium and zinc chromate and highly soluble would
include sodium and potassium chromates and dichromate.
http://www.atsdr.cdc.gov/csem/chromium/docs/chromium.pdf
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(PbCrO
4
PbMoO
4
Pb.SO
4
Al
2
O
3
), potassium chromate and dichromate, sodium chromate and
dichromate and zinc chromates.
A subset of six chromium (VI) compounds are listed in Annex XIV of the REACH Regulation
and so are, or will be, subject to 'authorisation' for continued use. Available evidence (e.g. from
the CAREX database) indicates that sodium, potassium, calcium and ammonium chromates and
dichromates have been identified as the most important exposures, a number of which are
already regulated under REACH.
The assessment of other chemical agents subject to REACH authorisation is deferred from this
report. However, as not all chromium (VI) compounds are listed in REACH Annex XIV the
same argument does not apply here.
Further, it is not possible based on available data to identify exposed populations or impacts
associated only with chromium (VI) compounds which are not listed on REACH Annex XIV,
nor to account for the impact REACH authorisation may have on exposures for those important
compounds to which it will apply.
The IOM study assessed impacts of introducing an OEL for all Chromium VI compounds,
including those subject to REACH.
While this analysis is based on best available data, it should be noted that this results in likely
overestimates of both the costs and benefits associated with setting an OEL under CMD for
Chrome (VI) compounds.
12.6.2 Synonyms
12.6.3 Classification according to Regulation (EC) N° 1272/2008 with regard to
carcinogenicity
Chromium (VI) compounds with the exception of barium chromate and of compounds otherwise
specified in Annex VI to the CLP Regulation have a harmonised classification as Carc. 1B –
May cause cancer by inhalation. 13 further chromium (VI) compounds have harmonised
classification entries as carcinogenic category 1.
12.6.4 Classification according to IARC
182
Group 1 - The agent is carcinogenic to humans
12.6.5 Conclusion of SCOEL
183
Non-cancer end-points:
In humans occupationally exposed by inhalation to hexavalent chromium compounds, the main
health effects are irritant and corrosive effects on the skin and respiratory tract. Effects on the
respiratory tract include inflammation of the nasal septum. Lower respiratory effects include
inflammation and obstructive disorders; transient impairment on lung function has been
reported. It is uncertain to what extent short-term exposure to high hexavalent chromium levels
or direct contamination of the nasal mucosa with chromium may be involved in the development
of the nasal lesions and this complicates a clear interpretation of the significance of the reported
average exposure levels in relation to these health outcomes. Renal dysfunction has been
reported in some studies, indicated by altered urinary protein or enzyme levels. In contrast,
some studies have reported no effects on kidney function. Irritant and corrosive effects on the GI
tract and effects in the liver have been reported following repeated exposure, but these cannot be
182
http://monographs.iarc.fr/ENG/Monographs/vol49/mono49-6.pdf and
http://monographs.iarc.fr/ENG/Monographs/vol100C/mono100C-9.pdf
Recommendation from the Scientific Committee on Occupational Exposure Limits: Risk assessment for
Hexavalent Chromium; SCOEL/SUM/86; December 2004
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related to exposure data. Hexavalent chromium compounds are potent skin sensitisers in humans
and can cause respiratory sensitisation, Sensitised individuals may also react to trivalent
chromium compounds. In general, the animal investigations from both single and repeated
exposures are supportive of the effects seen in humans although the data do not cover the wide
range of hexavalent chromium compounds in common use, most focussed on the highly soluble
compounds, and do not allow clear NOAELs to be established for the health endpoints
investigated.
Carcinogenicity:
A large number of epidemiological studies are available which have investigated cancer risks.
Studies of chromate production workers provide clear evidence of increased lung cancer
mortality. Excess risk of lung cancer mortality has also been reported for workers in the
chromate pigment industry, producing principally lead and zinc chromates. There is suggestive
evidence that zinc chromate, rather than lead chromate, is associated with the increased lung
cancer mortality in the pigment producing industry. One study of chrome platers provides clear
evidence of increased lung cancer risks and this finding is supported by other less informative
studies of chrome platers. Epidemiological investigations of ferrochrome workers, stainless steel
production workers and stainless steel welders have generated conflicting results and with the
added complication of co-exposure to known carcinogens, allow no conclusions to be reached
regarding lung cancer risks in relation to hexavalent chromium exposure in these industries.
Overall, only a few of the reported epidemiological studies provide exposure data and no single
study includes measurements of occupational exposures for all time periods under investigation.
Consequently, any quantification of lung cancer risk is based on limited data.
The carcinogenicity of a number of hexavalent chromium compounds has been investigated in
animal studies using various route of exposure; the most informative for the purpose of
estimating cancer risks to humans in occupational settings are inhalation, intratracheal
instillation and intrabronchial studies. In an inhalation study, in which rats were exposed to
sodium chromate (0.025, 0.05 or 0.1mg Cr/m
3
), increased lung tumours occurred only at the
highest dose. In a mouse inhalation study, increased lung tumours were associated with
exposure the calcium chromate at the concentration used of (4.3mg Cr/m
3
). Two mouse
inhalation studies showed a nonsignificant increase in lung tumours following exposure to
chromium (IV) oxide. These inhalation studies all suffered from some deficiencies in design.
Other inhalation studies, some of which investigated less soluble hexavalent chromium
compounds, had major deficiencies that prevented any conclusions being drawn. In one
intratracheal instillation study, increased lung tumour incidence was reported in rats following
exposure to calcium chromate. In the same study, sodium dichromate was associated with
increased lung tumour incidence in rats with 1.25mg/kg/week (0.5mg Cr/kg/week) administered
as one weekly dose, but not when the same weekly dose was administered in five instillations.
Other intratracheal instillation studies had major limitations, which prevented any conclusions
being drawn. An intrabronchial implantation study in rats demonstrated elevated lung cancer
incidence with calcium chromate, strontium chromate and zinc chromate, but failed to
demonstrate evidence for carcinogenicity of poorly soluble compounds (lead chromate or
barium chromate) or sodium dichromate, although the method may be inappropriate for highly
soluble compounds.
On the basis of the animal carcinogenicity data, it is concluded that there is evidence to suggest
a potency difference between hexavalent chromium compounds, probably related to solubility
and consequently bioavailability. However, the variation in design of the animal studies and,
crucially, the scarcity of reliable data for poorly soluble hexavalent chromium compounds
precludes definite distinctions being made, either qualitative or quantitative, between hexavalent
chromium compounds on the basis of the available animal studies done alone.
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The genotoxicity of hexavalent chromium compounds has been widely investigated in assays for
different genetic endpoints and has, with a few possible exceptions, been uniformly positive in
in vitro
assays for mutagenicity and clastogenicity, with evidence of
in vivo
expression of these
effects in some compounds. The possible exceptions are lead and barium chromate and these
two compounds have required solubilisation to elicit positive results in bacterial cell assays or to
enhance their genotoxic activity in mammalian cells. Although there appears to be a difference
in genotoxic potential between the various hexavalent chromium compounds tested based on
solubility, positive results were obtained with the poorly soluble compounds in some assays. It
is therefore not possible to exclude any compounds tested from possessing some mutagenic or
clastogenic potential.
Basis for recommending a limit:
The health effects associated with occupational exposure to hexavalent chromium compounds
are carcinogenicity, (specifically lung cancer), sensitisation, renal toxicity and irritancy, and
corrosivity of the skin, respiratory and gastrointestinal tract. Clearly, the most serious of these
outcomes in health terms is lung cancer and, given the magnitude of occupational cancer risks
shown in some of the earlier epidemiological studies, and given that hexavalent chromium
compounds are comprehensively genotoxic, it follows that lung cancer is the critical effect upon
which to base any occupational exposure limit. Ideally, it would be preferable to develop lung
cancer risk estimates for individual hexavalent chromium compounds (or a few groups of
compounds). Unfortunately, the quantity and quality of the epidemiological data are not
sufficient to rank, with any confidence, the carcinogenic potencies of the various hexavalent
chromium compounds encountered in industry. The available animal carcinogenicity
investigations do not provide this missing information. Notwithstanding the dearth of
appropriate human studies, the available human and experimental animal data indicate that
poorly soluble hexavalent chromium compounds have a lower carcinogenic potency than
soluble compounds. Such an effect might be explained be the relatively lower delivery of
bioavailably-active chromium ions to the intracellular target in the respiratory epithelium.
Lung cancer risk assessment:
The study of Mancuso (1975) currently dominates the risk assessments of hexavalent chromium;
USEPA, 1984; Gibb
et al,
1986; PCHRG 1993; Crump, 1995. However, this survey, with a total
of 41 lung cancer deaths available for analysis, does not constitute a large epidemiological
study. In addition, the job histories and exposure histories of study subjects seem to be poorly
described.
A risk assessment for hexavalent chromium based on epidemiological data, has been prepared
for the US Occupational Safety and Health Administration (OSHA) (Crump, 1995). This
assessment identified six sets of epidemiological data that provided some quantitative
information on chromium exposures (Mancuso, 1975; Hayes
et al,
1979; Langård
et al,
1980;
Axelsson
et al,
1980; Pokrovskaya & Shabynina, 1973; Sjögren
et al,
1987). The risk estimates
prepared for OSHA are that some 6-9 excess lung cancer deaths will be experienced over a
lifetime by a cohort of 1000 workers followed-up from the age of 20 years and occupationally
exposed to 1μg/m
3
of hexavalent chromium until retirement at age 65 years (Crump, 1995). At
an occupational exposure level of 50μg/m
3
, the predicted number of occupational lung cancers
was in the range 246 to 342. These assessments were based on data from the Mancuso (1975).
When the assessments were based on the cohort of Hayes
et al,
(1979) the corresponding figures
were 2 excess lung cancer deaths at an exposure level of 1μg/m
3
and 88 excess lung cancer
deaths at an exposure level of 50μg/m
3
. (The 4 other studies were judged to be less suitable for
any primary risk assessment.)
The study cohort of chromate production workers described by Hayes
et al
in 1979 was
redefined and updated (Gibb
et al,
2000). The new cohort comprised 2357 workers first
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employed between 1950 and 1974; follow-up was to the end of 1992. The new cohort included
990 workers who were employed for less than 90 days. These latter workers were included to
increase the size of the low exposure group. Short-term workers are often found to have unusual
patterns of mortality and it is unclear whether or not the inclusion of this group has been helpful.
The authors put considerable effort into characterising chromium exposures in different jobs and
different time periods. Unfortunately, the resulting job-exposure matrix is not reported. What is
clear, however, is that many estimated exposures must have been very low because 75% of the
cohort have estimated cumulative hexavalent chromium exposures in the range 0 -
0.0769mg/m
3
/y. A statistically significant non-monotonic positive trend is shown for lung
cancer in relation to four levels of cumulative hexavalent chromium exposure and the study
provides further evidence of excess lung cancer risks being causes by hexavalent exposure. The
incorporation of the study findings into quantitative risk assessment is problematical in that
three of the four exposure categories are so low (0 – 0.00149, 0.0015 – 0.0089 and 0.0090 –
0.0769mg CrO
3
/m
3
/y) A further follow-up of 332 workers, first employed at a US chromate
plant in the period 1931-37, has been reported by Mancuso (1997); follow-up was to the end of
1993. The study suffers from the absence of standard modern methods of analysis such as
Poisson regression. The reader is supplied with much of the raw data in terms of deaths, and
person-years-at risk shown by eight age-group categories and seven cumulative chromium
exposure categories (total, soluble and insoluble chromium exposure are shown in turn). There
then follows a descriptive account of patterns in the data rather than a statistical analysis that
seeks to identify the independent effects of different chromium exposures. The data reported
does not however, supply sufficient information to carry out the necessary analysis.
Interestingly, the overwhelming majority of the Gibb
et al,
2000 study population (perhaps in
order of 90% of the cohort) would be placed in the lowest exposure categories in the Mancuso,
1997 study.
Sorahan
et al
(1998) publishes a worked example of a quantitative risk assessment based on data
from a single cohort study of chrome platers. These calculations provided risk estimates that
were higher than those shown in the Criteria Document of Cross
et al
( 1997). The difference
arose, in the main, because different assumptions were made about the exposure conditions
pertaining to the study cohort. It is clear that under-or over-estimation of the exposure
conditions which gave rise to the observed lung cancer excesses will have dramatic effects on
any quantitative risk estimation derived from the epidemiological findings. It seems reasonable
to use estimates which are based on more than one study, and the estimates shown in
Table 4
in
Appendix 1
184
(column 1 relating to assumption 1) which are based on summary
epidemiological findings from ten published cohort studies are considered to involve more
reasonable assumptions about exposure conditions than do those predictions shown in other
columns of
Table 4.
The preferred risk assessment (see Appendix 1) is thus based on a summary of ten published
studies (Steenland
et al,
1996) and it has been estimated that about 5-28 excess lung cancers will
occur in a cohort of 1000 male workers, followed-up from age 20 to age 85 and occupationally
exposed to 50μ/m
3
of hexavalent chromium until retirement at age 65. The corresponding
number of excess lung cancers has been estimated to be 2-14 for an exposure level of 25μg/m
3
,
1-6 for an exposure level of 10μg/m
3
, 0.5-3 for and exposure of 5μg/m
3
and 0.1-0.6 for and
exposure level of 1ug/m
3.
It is important to recognise that there are a number of limitations attached to all the proceeding
estimates. They do not include statistical uncertainty and this will be considerable for the OSHA
assessments given the small number of deaths available for that analysis. Uncertainty also exists
regarding the appropriateness of the dose-response model employed. The model used assumes
184
see further details in the SCOEL recommendation as such
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linear extrapolation of cancer risks through the origin; there is no “threshold” dose, i.e. no dose
or dose rate below which there is no carcinogenic effect. This is particularly important in the
case of hexavalent chromium, which, because it is comprehensively genotoxic, could be
considered an ideal carcinogenic chemical agent to which to apply a “no threshold” linear
extrapolation. However, it should also be recognised that the irritant and inflammatory
properties of hexavalent compounds may also contribute to the carcinogenic process and that for
these effects there will be thresholds. It is not known to what extent irritancy may contribute
towards carcinogenicity but it is quite plausible that linear extrapolation to low doses, below
those seen in existing studies and where irritancy does not occur may over-estimate the true
cancer risk. One should also take into account the lung’s ability to reduce hexavalent chromium
to the non-genotoxic and non-carcinogenic trivalent species (De Flora, 2000). Unfortunately,
epidemiological data can contribute little to this important issue. Whilst epidemiological data
may shown no excess lung cancer risk in a low cumulative exposure category, it is most likely
that the confidence intervals attached to any such observed estimate of risk will include the
(low) projected risk estimate supplied by linear extrapolation of cancer effects observed at
higher cumulative exposures. Consequently, this aspect of model definition cannot be tested. In
addition, other aspects of the statistical model used in the risk assessment are not based on the
source data themselves. For example, any risk modifying effects of sex, age at exposure and
period of follow-up have not been estimated. It is also of concern that the risk assessments have
a sizable fraction of the total predicted risk occurring at ages beyond the follow-up ages
available in the source data.
The proposed risk estimate has, for reasons discussed, not drawn any distinction between highly,
sparingly and poorly hexavalent chromium compounds. However the available evidence, albeit
incomplete, strongly suggests that poorly soluble hexavalent compounds carry a lesser lung
cancer risk although the size of such a reduction cannot be quantified. Thus, in establishing
occupational exposure limits a pragmatic approach may be appropriate. As an example, an
exposure limit of 50μg/m
3
of hexavalent chromium may well provide adequate protection for
workers exposed to poorly soluble hexavalent chromium compounds but, on the basis of the risk
assessments described in Appendix 1, consideration could be given to setting exposure limits at
25μg/m
3
or 10μg/m
3
for other hexavalent chromium compounds.
12.7 1-3 Butadiene
12.7.1 Identification
Index Number:
EC Number:
CAS Number:
12.7.2 Synonyms
buta-1,3-diene, diethylene, divinyl, vinylethylene
12.7.3 Classification according to Regulation (EC) N° 1272/2008 with regard to
carcinogenicity
Carc. 1A – may cause cancer
12.7.4 Classification according to IARC
185
Group 1 - The agent is carcinogenic to humans
601-01300-X
203-450-8
106-99-0
185
http://monographs.iarc.fr/ENG/Monographs/vol97/mono97-6.pdf
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12.7.5 Recommendation of SCOEL
186
1,3 Butadiene was tested adequately for carcinogenicity in mice and rats by inhalation. In
independent experiments in mice, tumours were induced in both sexes, at multiple sites, at
concentrations ranging from 6.25 to 1,250 ppm. Exposure-related increases were observed for
numerous cancer types, including heart angiosarcoma, malignant lymphomas, lung
alveolar/bronchiolar adenomas and carcinomas, and forestomach papillomas and carcinomas. In
one experiment in rats, multiple-site increased tumour incidence was only seen at 8000 ppm.
The recent updating of the follow-up on a large North-American cohort of styrenebutadiene
rubber workers revealed a greater than twofold increase in leukaemia mortality among long-
term workers, with a significant dose-response relationship to cumulative exposure to butadiene
after adjusting for styrene and dimethyldithiocarbamate exposure; the independent effect of each
agent could not be firmly evaluated.
Two smaller cohort studies of butadiene production workers showed slight excesses of
lymphohaemopoietic cancers, but these were not considered to be associated with butadiene
exposure.
On the basis of the available evidence, the SCOEL agreed that 1,3 Butadiene should be treated
as a possible human carcinogen, operating via a genotoxic mechanism. Hence, according to the
established approach for such carcinogenic chemical agents, the excess risk entailed in exposure
during a working life to various concentrations of butadiene has been calculated using various
models; the results are illustrated in the Annexed table.
Based on the model used in the SCOEL recommendation, using the exposure estimates and their
associated relative rates reported in the most recent epidemiological study, SCOEL calculated
the additional leukaemia risk associated with exposure to 1 ppm (proposed OEL) 1,3 Butadiene
for a 40-year working life, as follows:
"In a population of 1.000 adult males experiencing a mortality rate similar to that of the male
population of England and Wales, occupational exposure to 1 ppm of 1,3 Butadiene for a
working life (40 years between the ages of 25 and 65), will cause from 0.0 to 10.78 extra
leukaemia deaths between the ages 25-85 years, in addition to the 5 leukaemia deaths expected
to occur in the absence of exposure to 1,3 Butadiene.”
No STEL or “skin” notation was considered necessary.
At the levels discussed, no measurement difficulties are anticipated.
12.8 Ethylene oxide
12.8.1 Identification
Index Number:
EC Number:
CAS Number:
12.8.2 Synonyms
Oxirane
12.8.3 Classification according to Regulation (EC) N° 1272/2008 with regard to
carcinogenicity
Carc. 1B – may cause cancer
186
603-023-00-X
200-849-9
75-21-8
Recommendation from the Scientific Opinion on Occupational Exposure Limits: Ris assessment for 1,3
Butadiene
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12.8.4 Classification according to IARC
187
Group 1 - The agent is carcinogenic to humans
12.8.5 Conclusion of SCOEL
188
The relevant endpoint for discussion of limiting occupational exposures to ethylene oxide is its
carcinogenicity.
Ethylene oxide is a weak alkylating agent that is directly mutagenic and carcinogenic. After
external exposure it is distributed within the entire organism, and in quantitative terms DNA
alkylation is relatively uniform in the body. This affects in a similar way tumour target and non-
target tissues. The carcinogenicity is clearly evident from animal experiments. In rats (Fischer
344), ethylene oxide has induced brain tumours, mononuclear cell leukaemias and peritoneal
mesotheliomas, in mice (B6C3F1) lung adenomas and carcinomas. In long-term experiments,
significant carcinogenic effects were seen upon repeated daily inhalation of 33 ppm and 100
ppm ethylene oxide. The carcinogenicity of ethylene oxide is reasonably connected with its
DNA alkylating and resulting genotoxic properties. IARC (2008) has assessed ethylene oxide to
be carcinogenic for humans (“Group 1”), rating the epidemiological evidence itself as being
limited, but considering further elements of mechanism/mode of action and “other relevant
data”.
Peritoneal mesotheliomas represent a quantitatively major malignancy induced in rats by
chemical carcinogens (e.g. acrylamide). In humans, such tumours can be induced by asbestos,
but not by such chemicals. There are no epidemiological indications, whatsoever, of such a
target site for ethylene oxide-induced carcinogenesis in humans. There are, however, indications
of haematopoietic/lymphatic cancer in humans that must be taken seriously, as evaluated by
IARC (2008). No consistent evidence in humans could be found for brain, lung and mammary
tumours. The available data on human haematopoietic/lymphatic cancer were therefore used as a
starting point of published quantitative risk assessments (Kirman et al 2004, Valdez-Flores et al
2010, 2011).
A unique feature for ethylene oxide is that low levels of this chemical are produced
endogenously by both the human and animal organism, and ethylene oxide represents therefore
a physiological body constituent. In experimental animals, repeated exposures to 10 ppm
resulted in statistically elevated DNA adducts, the main adduct being N7-(2-
hydroxethyl)guanine (HOEtG). In earlier publications, the physiological background of HOEtG
in rats was estimated to correspond to repeated exogenous exposures at 1 ppm ethylene oxide,
but during the last 20 years there have been gradual improvements of the methods of adduct
detection and quantitation (see Section 2.7). The most recent experimental study of Marsden et
al (2007; see Section 2.7), using LC-MS/MS, arrived at the conclusion that at a single or
repeated dose (i.p.) to rats of 0.01 mg/kg of ethylene oxide any DNA adduct increase was
negligible, compared to the endogenous damage already present. The extent of DNA damage
was linear with the dose applied, and the damage did not accumulate with repeated ethylene
oxide administration. The transpolation of these data into a human risk assessment is a matter of
current research, and more work into the underlying mechanisms will be needed to arrive at
valid risk conclusions (Swenberg et al 2011).
One problem is that experimental ethylene oxide exposures of rodents lead to a relatively
uniform distribution of HOEtG adducts in the DNA of both target and nontarget organs for
carcinogenicity, another problem is that promutagenic adducts other than HOEtG are detected
187
http://monographs.iarc.fr/ENG/Monographs/vol97/mono97-7.pdf and
http://monographs.iarc.fr/ENG/Monographs/vol100F/mono100F-28.pdf
Recommendation from the Scientific Committee on Occupational Exposure Limits for ethylene oxide;
SCOEL/SUM/160; June 2012
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only after very high experimental exposures. Human field data of Yong
et al
(2007) indicated
that human workplace exposures within the studied range of 0.36 ± 0.31 ppm 8-h TWA did not
lead to significant elevation of the HOEtG adduct levels in granulocyte DNA over the
endogenous background (see Section 2.7). This could suggest that the genotoxic risk of ethylene
exposures at lower levels ought to be practically negligible. At higher concentrations, ethylene
oxide exposures have led to genotoxic damage in occupationally exposed humans. Cytogenetic
signs of genotoxicity were visible at exposure levels of 5 ppm and above. At exposures of 1
ppm, no genotoxic changes could be directly established in exposed humans so far (see Section
2.6.2).
Although a non-linear dose-response (genotoxicity) relationship can reasonably be assumed
based on arguments of mode of action (Kirman
et al
2004), a definite noeffect level based on
dose-response data cannot be defined. In this situation, SCOEL provisionally categorises
ethylene oxide into “Group B” as a genotoxic carcinogen, for which a threshold is not
sufficiently supported (Bolt and Huici-Montagud 2008).
This situation calls for a quantitative cancer risk assessment. Because of the argumentation
given above (Section 2.8.3) this should preferably be based on epidemiological data on
haematological malignancies. The most recent assessment based on studies in approximately 20
000 workers of the combined NIOSH and UCC/Dow cohorts by Valdez-Flores et al (2011) was
considered by SCOEL as most reliable at present. The data (for males and females combined)
are compiled in Table 1.
There is a solid data base for biological monitoring, based on HOEtVal haemoglobin adduct
monitoring. Boogaard (2002) has compiled the argumentations and elements for establishing
biological limit values (BLV). A derivation was performed by Boogaard et al (1999) for
exposure conditions of an 8-h TWA of 0.5 ppm, corresponding to a HOEtVal level of 3.2 nmol
per g globin. In consequence, a TWA of 0.1 ppm would correspond to a biological haemoglobin
adduct value of 0.64 nmol (640 pmol) HOEtVal/g globin. Other extrapolated figures are
included in Table 1. The values given in Table 1 can still be distinguished from the general
background value of about 20 pmol HOEtVal/g globin.
A skin notation is warranted, as clear signs of systemic toxicity were reported after local
application of ethylene oxide (Section 2.3).
Table 2. Occupational exposure concentrations (TWA; exposure for working lifetime) and haemoglobin
adduct values corresponding to specified extra risks of lymphoid cancer mortality for males and females
combined, according to the evaluation of Valdez-Flores et al (2011).
Extra risk
4 x 10
-3
1 x 10
-3
4 x 10
-4
1 x 10
-4
4 x 10
-5
1 x 10
-5
12.9 1,2 Epoxypropane
12.9.1 Identification
Index Number:
EC Number:
CAS Number:
603-055-00-4
200-879-2
75-56-9
Corresponding TWA
(ppm)
21.35
6.58
2.77
0.712
0.286
0.072
corresponding Hb adducts
(nmol HOEtVal/g globin)
136.6
42.1
17.7
4.56
1.83
0.46
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12.9.2 Synonyms
Propylene oxide, methyloxirane
12.9.3 Classification according to Regulation (EC) N° 1272/2008 with regard to
carcinogenicity
Carc. 1B – may cause cancer
12.9.4 Classification according to IARC
189
Group 2B - The agent is possibly carcinogenic to humans
12.9.5 Conclusion of SCOEL
190
The primary aspect to be considered in deriving an OEL for propylene oxide is its local
carcinogenicity with the nasal epithelium as primary target, which is well established
experimentally in rats and mice. So far, there is no evidence of carcinogenity of propylene oxide
from studies in humans.
Propylene oxide is the methyl homologue of ethylene oxide. Like ethylene oxide, it has
alkylating properties. This leads to hydroxypropylation of biological macromolecules.
Hydroxypropylation of the N-terminal valine in haemoglobin is used as a means of biological
monitoring, and hydroxypropylation of DNA bases is viewed in conjunction with genotoxicity.
Compared to ethylene oxide, the alkylating power of propylene oxide is about 4 times lower
(Pauwels and Veulemans, 1998). The metabolism of both, ethylene oxide and propylene oxide,
is qualitatively similar, via glutathione transferase and expoxide hydrolase, but differs
quantitatively. At similar conditions of human industrial exposure, the levels of haemoglobin
alkylation produced by propylene oxide are about 10 times lower compared to ethylene oxide
exposure (Boogaard, 2002).
In contrast to ethylene oxide, the primary target of both toxicity and carcinogenicity of
propylene oxide is at the port of entry into the organism. With inhalation exposure, this is the
nasal epithelium. The carcinogenic potency at this site of propylene oxide is relatively weak. In
long-term experiments mice, nasal tumours were observed at 400 ppm, and no tumours were
seen at 200 ppm. In rats, such tumours were detected at 300 ppm, and no tumours were seen at
the lower concentration of 100 ppm (chapter 2.8.2).
The EU Risk Assessment Report (ECB 2002) has addressed propylene oxide to be a genotoxic
carcinogen, without an identifiable threshold. Yet, recent investigations into the mode of action
of rodent nasal carcinogenesis due to propylene oxide inhalation point to decisive contributions
of several factors besides genotoxicity. Upon propylene oxide inhalation, glutathione depletion
is most marked in nasal respiratory mucosa, where a level of only 43% of control was observed
following a single exposure of rats to 50 ppm for 6 h. At inhalation of 5 ppm the gluthathione
level at this site was maintained at 90% (Lee et al., 2005; see chapter 2.1.1). This is important,
because gluthatione has an important scavenging function in the detoxification of propylene
oxide. For cytotoxic and proliferative changes in the nasal epithelium Eldridge et al. (1995)
determined a NOAEL of 50 ppm in a 4-week study in rats (see chapter 2.5.2). Similarly, Kuper
et al. (1988) found focal hyperplasia of the nasal turbinates and degenerative changes and
proliferative hyperplasia of the nasal epithelium, particularly at the highest concentration tested
(300 ppm propylene oxide). At 30 ppm these responses were rated „slight“ and of low incidence
(and only identified in the 28-month treatment group), compared to the greater incidence of
189
190
http://monographs.iarc.fr/ENG/Monographs/vol60/mono60-9.pdf
Recommendation from the Scientific Committee on Occupational Exposure Limits for propylene oxide;
SCOEL/SUM/161; August 2010
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„moderate“ effects at 100 ppm (Reuzel and Kuper, 1983, Kuper et al., 1988). This study
therefore points to a LOAEL of 30 ppm.
Apart from the local toxic and neoplastic effects of propylene oxide at the portal of entry into
the organism, a systemic genotoxicity must be considered. Occupational genotoxicity studies
performed on propylene oxide are scarce compared to those on ethylene oxide (Preston, 1999;
Albertini and Sweeney, 2002). Czene et al. (2002), using the parameter of sister chromatid
exchanges (SCE) in human lymphocytes, found that SCE frequencies at low occupational
exposures (below 2 ppm propylene oxide) are not distinguished from those of non-exposed
controls (see chapter 2.6.2). However, in view of the scattering of the general background of this
parameter and of other arguments (Albertini 2003) the practical relevance of this finding is not
clear.
Because there is a well-established mode of action for the local carcinogenicity (Albertini and
Sweeney, 2002), propylene oxide is assigned to the SCOEL carcinogen group C, which is
characterised by a practical threshold (Bolt & Huici-Montagud, 2008).
Considering (i) a LOAEL shown for local changes at the rat nasal epithelium at 30 ppm and (ii)
an only minimal local glutathione depletion in the nasal tissue of the rats at 5 ppm, a health-
based OEL should be set well below 5 ppm. A species scaling with regard to humans is not
required in this case, as it is generally accepted that the nasal epithelium of rodents is more
susceptible to irritation and irritation-based carcinogenicity than that of humans. Therefore, it is
proposed to set the health-based OEL for propylene oxide at 1 ppm [2.41 mg/m
3
]. This also
takes into account the results of Czene et al. (2002) of a no observed SCE effect in workers
below 2 ppm exposure.
According to Boogaard (2002; see chapter 2.1.3) this OEL corresponds to a BLV of 1.3 nmol N-
(3-hydroxypropyl)-valine haemoglobin adduct per g globin.
There is no data available to propose a STEL.
This OEL and BLV derivation is also supported by the following:
(i) In chapter 2.6.4 it has been deduced that a mean TWA exposure of 2 ppm propylene oxide
would correspond to a mean DNA adduct frequency of N
7
-(2-hydroxypropyl)guanine of 3.3 x
108. Accordingly, the frequency of this major propylene oxide DNA adduct, induced at the
proposed OEL, would be 1.65 x10
8
. This is a factor of 20 below the physiological level of the
corresponding ethylene oxide adduct, N
7
-(2-hydroxyethyle)guanine, in human lymphocytes of
non-smokers (Zhao & Hemminki 2002; see also SCOEL/SUM/160 for ethylene oxide), and
confirms that no substantial genotoxic risk is associated with the proposed OEL and BLV.
(ii) Just recently, Sweeney et al. (2009) have again compiled all arguments, based on mode of
action, that propylene oxide represents a carcinogen with a practical threshold. In addition to
this, they also performed calculations, based on benchmark dose modelling, of a “human
reference concentration” (RfC), according to current guidance of the U.S. Environmental
Protection Agency (EPA 2005). Their resulting RfC values were in a range of 0.4 - 0.7 ppm,
which is close to the OEL proposed here based on threshold assumption and experimental
NOAEL/LOAEL.
There are no data at present on skin absorption of propylene oxide, which could serve as a data
base for a skin notation.
12.10
o-Toluidine
12.10.1
Identification
612-091-00-X
128
Index Number:
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EC Number:
CAS Number:
12.10.2
2-aminotoluene
202-429-0
95-53-4
Synonyms
12.10.3
Classification according to Regulation (EC) N° 1272/2008 with regard to
carcinogenicity
Carc. 1B – may cause cancer
12.10.4
12.10.5
Classification according to IARC
191
Conclusion of SCOEL
Group 1 – The agent is carcinogenic to humans
Is currently being developed.
12.11 2 Nitropropane
12.11.1
Identification
609-002-00-1
201-209-1
79-46-9
Index Number:
EC Number:
CAS Number:
12.11.2
Synonyms
12.11.3
Classification according to Regulation (EC) N° 1272/2008 with regard to
carcinogenicity
Carc. 1B – may cause cancer
12.11.4
12.11.5
Classification according to IARC
192
Conclusion of SCOEL
Group 2B - The agent is possibly carcinogenic to humans
Is currently being developed.
12.12 Bromoethylene
12.12.1
Identification
602-024-00-2
209-800-6
593-60-2
Vinyl bromide
Index Number:
EC Number:
CAS Number:
12.12.2
Synonyms
191
http://monographs.iarc.fr/ENG/Monographs/vol77/mono77-11.pdf
http://monographs.iarc.fr/ENG/Monographs/vol99/mono99-15.pdf and
http://monographs.iarc.fr/ENG/Monographs/vol100F/mono100F-11.pdf
http://monographs.iarc.fr/ENG/Monographs/vol1-42/mono29.pdf and
http://monographs.iarc.fr/ENG/Monographs/vol71/mono71-49.pdf
129
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12.12.3
Classification according to Regulation (EC) N° 1272/2008 with regard to
carcinogenicity
Carc. 1B – may cause cancer
12.12.4
12.12.5
Classification according to IARC
193
Conclusion of SCOEL
194
Group 2A - The agent is probably carcinogenic to humans
Vinyl bromide is clearly carcinogenic in experimental animals. It has been categorized by IARC
(2008) as “probably carcinogenic to humans (Group 2A)”. According to the available bioassay
data the carcinogenic effects are similar to those of vinyl chloride. The close relation between
vinyl bromide and vinyl chloride is supported by comparative data on metabolism, nucleic acid
adduct formation and formation of pre-neoplastic hepatic foci. This is consistent with the view
of IARC (2008) that vinyl bromide should be considered to act similarly to the established
human carcinogen, vinyl chloride. A reasonable quantitative comparison of the experimental
carcinogenicity of vinyl bromide and vinyl chloride is possible when toxicokinetic aspects are
integrated. This leads to the conclusion that in the occupationally relevant low exposure range
vinyl bromide appears to be about 3 times more active than vinyl chloride.
Based on the argumentations on the mode of action for vinyl chloride (SCOEL/SUM/109) and
considering the close similarity of both vinyl halides no threshold mechanism can be supported
for both vinyl halides. In consequence and according to the SCOEL strategy for carcinogens
(Bolt and Huici-Montagud 2008), vinyl bromide is grouped into group A of carcinogens (non-
threshold carcinogen; for low-dose assessment of risk the linear non-threshold model appears
appropriate).
As the available body of data that can be used for a quantitative assessment of carcinogenic risk
is much larger for vinyl chloride than for vinyl bromide, SCOEL recommends to use the
existing quantitative risk assessment for vinyl chloride (SCOEL/SUM/109) also for vinyl
bromide, considering a three times higher potency of vinyl bromide compared to vinyl chloride.
The hepatic angiosarcoma risk for vinyl chloride, upon inhalation exposure for working lifetime
to 1 ppm inferred from epidemiological data, has been assessed by SCOEL to be 3 x 10
-4
(SCOEL/SUM/109). Independent data, derived from animals and using PBPK modelling, point
to a similar order of magnitude (between 0.2 and 1.6 x 10
-3
, and thereby confirm this approach.
Accordingly, for a similar exposure to vinyl bromide the hepatic angiosarcoma risk is
considered to be 9 x 10
-4
.
12.13
12.13.1
Hydrazine
Identification
007-008-00-3
206-114-9
302-01-2
Index Number:
EC Number:
CAS Number:
12.13.2
Diamide
193
Synonyms
http://monographs.iarc.fr/ENG/Monographs/vol1-42/mono39.pdf
http://monographs.iarc.fr/ENG/Monographs/vol71/mono71-40.pdf and
http://monographs.iarc.fr/ENG/Monographs/vol97/mono97-9.pdf
Recommendation from the Scientific Committee on Occupational Exposure Limits for vinyl bromide;
SCOEL/SUM/155. September 2008
130
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12.13.3
Classification according to Regulation (EC) N° 1272/2008 with regard to
carcinogenicity
Carc. 1B – may cause cancer
12.13.4
12.13.5
Classification according to IARC
195
Conclusion of SCOEL
196
Group 2B – The agent is possibly carcinogenic to humans
The relevant toxicological endpoint for hydrazine is carcinogenicity. IARC (1999) has evaluated
the evidence of carcinogenicity in experimental animals as being sufficient and summarised that
the compound had been tested by oral administration to mice in several experiments, producing
mammary and lung tumours. When tested by oral administration or inhalation exposure in rats,
it produced lung, liver and nasal tumours and a few colon tumours in hamsters; it produced liver
tumours and thyroid adenomas following oral or inhalation exposure (IARC 1999).
Among this body of data, the most useful information comes from the long-term inhalation
studies and is related to the upper respiratory tract. In mice, exposed in a preliminary study for 6
months at 0.2, 1, or 5 ppm, there was an increased incidence of pulmonary tumours in all groups
(Haun & Kinkead, 1972; MacEwen, 1974). A subsequent inhalation study in rats, mice, dogs
and hamsters (6h/d; 5d/wk at 0.05 ppm [rats, mice], 0.25 and 1.0 ppm [rats, mice, hamsters,
dogs] for 1 year with a follow-up for life span or 38 months revealed an increased incidence of
benign and malignant nasal tumours at 1 and 5 ppm in rats. At 0.05 ppm, the incidence of nasal
tumours in rats was slightly, but not significantly, over the controls. An increased incidence of
benign nasal polyps was observed in hamsters at 5 ppm. In addition, hamsters exposed at 0.25
ppm showed pathological degenerative changes, including amyloidosis. An increased incidence
of pulmonary adenomas was observed at 1 ppm in mice (MacEwen et al., 1979; Vernot et al.,
1985).
The evidence of hydrazine carcinogenicity in humans was evaluated by IARC (1999) as being
inadequate. In the meantime, however, the studies of Ritz et al. (1999, 2006) have pointed to the
possibility of a carcinogenic effect in exposed areospace workers, in particular to an increased
lung cancer mortality (see 2.8.1). This would be compatible with the aforementioned
experimental data.
Hydrazine has been characterised as genotoxic. Studies into the mode of action have revealed an
indirect mechanism of genotoxicity, involving reaction with endogenous formaldehyde and
ultimate formation of a DNA-methylating agent.
In principle, the systemic genotoxicity of hydrazine, based on such an indirect mechanism, may
be characterised by a threshold at low exposure levels (when hydrazine-induced DNA
methylation becomes insignificant vs. the normal methylation background). However, the
critical target upon occupational inhalation exposure is the respiratory tract, and specific studies
into the local mode of carcinogenic action, as well as appropriate toxicokinetic modellings, are
lacking.
There are considerable species differences regarding hydrazine carcinogenicity at the upper
respiratory tract, and caution is warranted in view of the possibility of generation of human lung
cancer. In this situation, the derivation of a health-based OEL, or a reasonable quantitative risk
assessment based on experimental tumour data, is not possible at the present time.
195
http://monographs.iarc.fr/ENG/Monographs/vol1-42/mono4.pdf
http://monographs.iarc.fr/ENG/Monographs/suppl7/Suppl7-90.pdf and
http://monographs.iarc.fr/ENG/Monographs/vol71/mono71-43.pdf
Recommendation from the Scientific Committee on Occupational exposure Limits for hydrazine,
SCOEL/SUM/164,, August 2010
131
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Therefore, hydrazine is categorised into the SCOEL carcinogen group B, as a genotoxic
carcinogen, for which the existence of a threshold cannot be sufficiently supported at present
(Bolt & Huici-Montagud, 2007).
The systemic effects seen in animals following dermal contact warrant a 'skin notation'.
As there are no adequate data, a recommendation for biological monitoring cannot be given.
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13 A
NNEX
6 - E
XPOSURE
L
IMIT
V
ALUES IN
EU M
EMBER
S
TATES AND SOME NON
-EU C
OUNTRIES
Table 1. OELs in EU MS
Hardwood Vinyl
Silica
RCF
3
dust
chloride (respirable) f/ml
3
mg/m
mg/m
3
mg/m
3
AT
BE
BG
CY
CZ
DE
DK
EE
EL
ES
FI
FR
HR
HU
IE
IT
LT
LU
LV
MT
2
3
5
5
2,0
2
1
2
4,92
5
5/2
1
5
5
5
5
5
5
5
5
5
7,77
2,5
7,77
7,5
7,77
3
3
7,64
7,8
7,7
2,59
7,77
7,77
7,77
7,77
7,77
7,77
7,77
7,77
0,15
0,05-0,1
0,07
0,3 - 1,0
1
0,1
-
0,1
0,05-0,1
0,3 - 1,0
1
0,05
0,05
0.05-0.1
0,05
0,15
0,1
-
0,05 - 0,1
-
-
0,025
2
0,5
0,5
-
2
0,3
-
1
-
-
0,5
0.2
-
-
1-2
1
-
-
-
-
0,2
2
1,3
Butadiene
mg/m
3
11 to 34
4,5
-
-
10
-
22
1
22
4,5
2,2
-
22
1
36
-
1
-
100
4,4
Chromium
(VI)
compounds
mg/m
3
0,05-0,1
0,01 -0,05
0,05
2
0,05
-
0,005
0,02
0,5
0.01 -0.05
0,05
0,001
0,05
-
0,01-0,05
-
0,005
-
0,01
0,01
–
Acrylamide Ethylene 1,2
mg/m
3
oxide
Epoxy-
3
mg/m
propane
mg/m
3
0,03-0,06
2
6
0,03
1,8
5
0,03
2
-
-
90
-
-
1
-
-
-
4,8
0,03
1,8
12
0,03
2
5
0,3
10
50
0,03
1,8
4,8
0,3
1,8
2,4
0,3
1,8
50
0,3
9,2
12
0,03
1,8
5
0,03
10
12
-
-
-
0,03
2
5
-
-
-
0,2
1
1
2
0,03
1,8
-
Bromo-
ethylene
mg/m
3
-
2,2
-
-
-
-
20
-
-
2,2
4,4
-
20
-
2,2
-
-
-
-
5
2-
Nitropropane
mg/m
3
18
37
35
-
-
-
18
18
35
19
18
-
19
-
18
-
7
-
-
2,2
o-
Hydrazine
Toluidine mg/m
3
ppm
0,1
2
-
-
-
-
2
-
2
0,2
2
2
0,2
-
0,2
-
-
-
0,1
2
2
0,13
0,013
0,1
-
0,05
-
0,013
0,1
0,13
0,013
0,13
0,1
0,03
-
0,01
-
0,1
-
0,1
-
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Hardwood Vinyl
Silica
RCF
3
dust
chloride (respirable) f/ml
3
mg/m
mg/m
3
mg/m
3
1,3
Butadiene
mg/m
3
NL
PL
PT
RO
SE
SI
SK
UK
2
2
5
5
2
5
5
5
7,77
5
7,77
7,77
2,5
7,77
7,77
7,8
0,075
0,.3 - 1,0
1
-
0,05- 0,1
0,05- 0,1
-
0,1
0,1
0,5
0,5-1
-
-
0,2
-
0,8
1
46,2
4,4
-
22
1
11 to 34
11
22
Chromium
(VI)
compounds
mg/m
3
0,05
2
0,025
0,1
-
0,05
0,005
2
0,005 - 0.1
0,05
Acrylamide Ethylene 1,2
mg/m
3
oxide
Epoxy-
3
mg/m
propane
mg/m
3
0,16
0,1
-
0,03
0,003
0.03-0,06
0,03
0,3
0,84
1
-
1,8
2
2
2
9,2
6
9
-
50
5
6
12
12
Bromo-
ethylene
mg/m
3
2-
Nitropropane
mg/m
3
o-
Hydrazine
Toluidine mg/m
3
ppm
0,012
0,4
-
22
-
-
-
-
0,036
-
-
-
7
18
18
19
-
-
-
-
-
0,1
-
0,2
-
0,05
-
0,10
-
0,13
0,13
0,03
Note 1: OELs are calculated in a case-by-case basis as a function of the % free silica. In the case of Poland, they provide an indicative range: 0.3-1.0 mg/m
3
, which is assumed here to be the range for CY
and EL as well. Note 2: Values not included in national legislation but referred from national authorities as to be enforceable (technically sound values published by ACGIH).
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Table 2. OELs in EU MS – compared to levels recommended by the ACSH (option 2)
Substance
Hardwood dust
Vinyl chloride
MS having no or higher OEL
BG,CY, EL, ES, FIp, HR,HU,IE, IT,LT, LU, LV,MT,PT, RO, SI, SK,UK
Total number
18
25
11
24
23
21
13
9
26
22
14
25
24
AT, BE, CY, CZ, DE, DK, EE, EL, ES, FI, HR, HU, IE, IT, LT, LU, LV, MT, NL, PL,
PT, RO, SI, SK, UK
AT, CY, DE, EL, HU, IT, LU, LV,PL, PT, SI
Silica
AT, BE, BG, CY, DE, DK, EE, EL, ES, FR, HR, HU, IE, IT, LT, LU, LV, NL, PL, PT,
RCF
RO, SI, SK, UK
AT, BE, BG, CY, CZ, DE, DK, EL, ES, FR, HR, IE, IT, LU, LV, MT, NL, PL, PT, RO,
1,3-Butadiene
SI, SK, UK
Chromium (VI)
AT, BEp, BG, CY, CZ, DE, EL, ESp, FI, HR, HU, IEp, IT, LU, MTp,PL, PT, RO, SI,
SKp, UK
compounds
CY, CZ, DE, EL, FI, FR, HR, IT, LU, LV, NL, PT, UK
Acrylamide
CY, DE, EL, HR, IE, IT, LU, PT, UK
Ethylene oxide
AT, BE, BG, CY, CZ, DE, DK, EE, EL, ES, FR, HR, HU, IE, IT, LT, LU, MT, NL, PL,
1,2-
PT, RO, SE, SI, SK, UK
Epoxypropane
AT, BG, CY, CZ, DE, DK, EE, EL, FR, HR, HU, IT, LT, LU, LV, MT,PT, RO, SE, SI,
Bromoethylene
SK, UK
2-Nitropropane
BE, BG, CY, CZ, DE, EL, FR, HU, IT, LU, LV, PL, PT, RO
BE, BG, CY, CZ, DE, DK, EE, EL, ES, FI, FR, HR, HU, IE, IT, LT, LU, MT, NL, PL,
o-Toluidine
PT, RO, SE, SK, UK
AT, BG, CY, CZ, DE, EE, EL, FI, FR, HR, HU,IT, LT, LU, LV, MT, NL, PL, PT, RO,
Hydrazine
SE, SI, SK, UK
p
– partially (the OEL is provided as a range that includes the proposed value)
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Table 3. OELs in some non-EU countries
Chemical agent
1,2 –
Epoxypropane
mg/m
3
1,3 Butadiene
ppm
2 Nitropropane
mg/m
3
Acrylamide
(mg/m
3
)
Bromoethylene
(mg/m
3
)
Hexavalent
Chromium
(mg/m
3
)
Ethylene oxide
(ppm)
Hardwood dust
(mg/m
3)
o-Toluidine
(ppm)
Hydrazine (mg/m
3
)
Refractory Ceramic
Fibres (f/ml)
Respirable
crystalline silica
(mg/m
3
)
Retained
option
2,4
Australia
48
Canada
48 (Québec)
US
240
China
5
Switzerland
6
New Zealand
12
Japan
n.a.
1
18
0,1
4,37
0,025
10
36
0,03
22
0,05
2
35 (Ontario)
36 (Québec)
0,03
22
0,05
1
90
0,03
n/a
0,001
NIOSH
0,005 OSHA
1
n/a
5
1,3
n/a
0,05
(NIOSH)
30/(%silica+
2) total dust
and
2,22
30
0,3
n/a
n/a
5
18
10
19
n.a.
n/a
0.1
n/a
0,05
0.03 inhalable 0.03
aerosol
22
22 mg/m
3
0,05 inhalable 0,05
aerosol
1
2
inhalable
aerosol
0,1
0,13
0,25
1
1
0,2
0,013
n/a
0,2
1
3
0,1
0,013
0,3
0,1
1
1
2
0,013
0,5
0,1
1
1
2
0,013
0,5
0,1
2
n/a
n/a
0,06
n/a
1
n/a
n/a
n/a
n/a
n/a
Inhalable fraction: 0,15
1 (10% <= free respirable
SiO2 <= 50%)0,7 aerosol
(50% < free SiO2
<= 80%)
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Chemical agent
Retained
option
Australia
Canada
US
China
Switzerland
New Zealand
Japan
VCM (ppm)
1
5
1
10/(%silica+
0,5 (free SiO2 <
2) respirable 80%)
dust (OSHA)
1
3,85
2
5 ppm
2 ppm
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Table 4. Exposures in Member States which have no OEL or an OEL higher that the value proposed by the ACSH (option 2)
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14 A
NNEX
7 - R
ELEVANT
EU
LEGISLATION
14.1 Existing EU-OSH framework
14.1.1 Directive 89/391/EEC
The aim of the Framework Directive is to introduce measures to encourage
improvements in the safety and health of workers at work. To this end it contains general
principles concerning the prevention of occupational risks, the protection of safety and
health, the elimination of risk and accident factors, the informing, consultation, balanced
participation in accordance with national laws and/or practices and training of workers
and their representatives, as well as general guidelines for the implementation of the said
principles.
The Framework Directive applies to all sectors of activity, both public and private. It
establishes in particular the duty of the employer to ensure the safety and health of
workers in every aspect related to the work. It requires the employer to take the measures
necessary for the safety and health protection of workers, including prevention of
occupational risks and to implement these measures on the basis of general principles of
prevention, among which “avoiding risks”, “evaluating the risks which cannot be
avoided”, “combating the risks at source” and “replacing the dangerous by the non-
dangerous or the less dangerous”.
14.1.2 Directive 98/24/EC
The Directive lays down minimum requirements for the protection of workers from the
risks to their safety and health arising, or likely to arise, from the effects of chemical
agents that are present at the workplace or as a result of any work activity involving
chemical agents.
The Directive provides for the drawing up of indicative occupational exposure limit
values (IOELs) and binding occupational exposure limit values (OELs) as well as
binding biological limit values (BBLVs) at EU level.
197
For any chemical agent for which an IOEL is established at EU level, Member States
must establish a national occupational exposure limit value (OEL), taking into account
the EU limit value. Along the same lines, OELs and BBLVs may be drawn up at EU
level taking into account feasibility factors. For any chemical agent for which a OEL or a
BBLV is established at EU level, Member States must establish a corresponding national
binding OEL or a binding BLV that does not exceed the EU limit value.
The employer must determine whether any hazardous chemical agents are present at the
workplace and assess any risk to the safety and health arising from their presence.
The employer must take the necessary preventive measures set out in Article 6 of
Directive 89/391/EEC and risks must be eliminated or reduced to a minimum following
the hierarchy of prevention measures, among which substitution (replacing a hazardous
chemical agent with a chemical agent or process which is not hazardous or less
hazardous) must by preference be undertaken, whereas wearing personal protective
equipment is the least preferred option.
In addition to the above mentioned requirements, which are most relevant for this topic,
the employer must also take other preventive and protective measures on a regular basis
197
The distinction between IOELs, on the one hand, and BOELs and BBLVs, on the other hand, lies in the
methods used for their derivation: while IOELs are purely health based, BOELs and BBLVs are drawn
up also taking into account feasibility or workability factors. IOELs constitute thresholds of adverse
health effects and therefore exposure below these limit values should not, in theory, result in a risk for
the workers’ health
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(e.g. health surveillance of workers, training of workers). The competent authorities of
the Member States have the obligation to ensure compliance with these requirements.
The Directive has been implemented into national law in all Member States.
14.1.3 Directive 2004/37/EC
Directive 2004/37/EC requires eliminating or reducing to a minimum the risks arising
from the occupational exposure to carcinogenic or mutagenic chemical agents and
mixtures. In order to further reduce the occupational exposure to these particular
hazardous chemical agents / mixtures, the Directive lays down specific requirements,
which go beyond the preventive and protective measures foreseen in the Framework
Directive 89/391/EEC and the Chemical Agents Directive 98/24/EC.
Whether a chemical agent or a mixture is under the scope of the Directive is primarily
based on their classification as a carcinogen or a mutagen (category 1A or 1B) according
to the criteria established under the CLP Regulation).
However, there is also a possibility to bring a chemical agent / mixture under the scope
of the Directive, by including it in Annex I to the Directive. This Annex covers chemical
agents, mixtures or processes (or chemical agents / mixtures released by a process
referred to in that Annex) – so-called process-generated chemical agents or PGSs - which
are not classified according to the CLP Regulation as carcinogens or mutagens, but are
recognised by other international bodies (like the International Agency for Research on
Cancer - IARC) as chemical agents, mixtures or processes of equal concern.
The Directive has been implemented into national law in all Member States.
14.1.4 Directive 2009/148/EC
Directive 2009/148/EC applies to activities in which workers are or may be exposed in
the course of their work to dust arising from asbestos or materials containing asbestos.
It requires in particular that a risk assessment be carried out by employers ‘in the case of
any activity likely to involve a risk of exposure to dust arising from asbestos or materials
containing asbestos’ and in such a way as to determine the nature and degree of
exposure. Depending on the initial risk assessment, the asbestos fibres in the air are to be
measured regularly. Employers must ensure that exposure is reduced to a minimum via
the adoption of several risk management measures and in any case below the limit value
of 0,1 fibres per cm 3 as an 8-hour time-weighted average. The Directive also establishes
specific obligations regarding the information, training and health surveillance of
workers and contains specific requirements as regards demolition, asbestos removal
work, repairing and maintenance.
The provisions of Directive 2004/37/EC apply as regards asbestos whenever they are
more favourable to health and safety at work. All Member States have transposed this
Directive.
14.2 Internal Market legislation
14.2.1 REACH Regulation
REACH stands for Registration, Evaluation and Authorisation and Restriction of
Chemicals.
It requires all companies manufacturing and importing chemicals into the EU in
quantities of one tonne or more per year to register this chemical with the European
Chemical Agency (ECHA) in Helsinki, to evaluate the risks resulting from the use of
those chemicals and to take the necessary steps to manage any identified risk to human
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health and the environment. Industry has the burden of proving that chemicals
manufactured and placed on the EU market are safe.
If a safe use cannot be demonstrated, authorities have the possibilities to restrict its use
by either submitting it to the restriction or the authorisation procedure.
'Restriction' is the procedure via which the manufacture, use or placing on the market of
the chemical is subject to a restriction. A Member State, or ECHA on request of the
European Commission, can propose restrictions if they find that an unacceptable risk
needs to be addressed on EU wide basis.
'Authorisation' aims to ensure that the risk from a Substance of Very High Concern
(SVHC) is properly controlled and that these chemicals are progressively replaced by
less hazardous suitable alternatives. SVHC are amongst others chemical agents which
meet the criteria for classification as carcinogenic, mutagenic or toxic to reproduction,
Category 1A or 1B according to the CLP Regulation. Chemicals subject to authorisation
cannot any longer be placed on the market or used after certain date, unless an
authorisation is granted for their specific use, or the use is exempted from authorisation.
In order to receive an authorisation, manufacturers, importers or downstream users have
to apply for authorisation if they want to use the chemical agent after the aforementioned
date.
REACH status of the 13 chemical agents under consideration is presented in the table
below.
Table 1. REACH status of chemical agents in present proposal
Chemical Agent
Acrylamide
REACH STATUS
1 full registration (joint submission): 100 000 - 1 000
000 tonnes per annum. 2 intermediate registrations
(both individual submissions, tonnages undisclosed)
Added to Candidate List of 'substances of very high
concern' potentially to be made subject to
authorisation. Restricted (REACH.XVII.60) for use in
grouting (significant but narrow worker protection).
1 full registration (joint submission): 100 000 - 1 000
000 tonnes per annum
Added to Candidate List of 'substances of very high
concern' potentially to be made subject to
authorisation. ECHA have recommended this agent be
added to REACH Annex XIV. REACH authorisation
regulatory proposal imminent.
1 full registration (joint submission): 1 000 000 - 10 000
000 tonnes per annum
Complex REACH status as there are 100+ Chromium
(VI) compounds.
50 of these have been pre-registered but not registered
or covered by authorisation. Others registered as full
RCF
1,3 Butadiene
Chromium (VI) compounds
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and/or intermediate registrations.
A subset of chromium (VI) compounds are subject to
authorisation.
198
Restricted (REACH.XVII.47) for use
(above v low concentration) in cement (ltd. worker
protection). Very widespread and important substance.
Ethylene oxide
1 full registration (joint submission): 1 000 000+ tonnes
per annum. 4 intermediate registrations (all individual
submissions, tonnages undisclosed). Also several
registrations for related but distinct substances.
Hydrazine
Added to Candidate List of 'substances of very high
concern' potentially to be made subject to authorisation.
2 Nitropropane
1 full registration (joint submission): 1 000 - 10 000
tonnes per annum. Many registrations for related but
distinct substances
RCS (crystalline silica, Complex registration status.
quartz)
As mineral substances which occur in nature silicone
dioxide (i.e. silica) is exempt from the REACH
registration obligation. Further, RCS which meets the
proposed definition as a process generated substance
under CMD would not normally be in scope of REACH
registration, which applies to chemical substances
placed on the EU market above one tonne per year (and
hence not to chemical agents generated
in situ).
Nevertheless, there are 2 full registrations for silicon
dioxide (one joint, one individual) at high tonnages and
many related registrations.
o-Toluidine
1 full registration (joint submission): 10 000 - 100 000 tonnes
per annum. 1 intermediate registration individual
submission, tonnage undisclosed)
Added to Candidate List of 'substances of very high
concern' potentially to be made subject to authorisation.
Vinyl chloride
3 full registrations: 1 joint submission at 1 000 000 - 10 000
000 tonnes per annum, 2 intermediate registrations at 0-10
tonnes per annum
Restricted (REACH.XVII.2) for use as an aerosol propellant
(ltd. worker protection). Existing BOELV to update.
Hardwood dust
Out of scope of REACH
1,2 Epoxypropane
1 full registration (joint submission): 1 000 000+ tonnes
per annum. Various intermediate registrations as
individual submissions, tonnages undisclosed
Vinyl
bromide 2 intermediate registrations (individual submissions,
(bromoethylene)
tonnages undisclosed)
14.2.2 CLP Regulation
The CLP Regulation (for "Classification, Labelling and Packaging") is the EU
Regulations which aligns the previous EU system of classification, labelling and
198
Trichloroethylene, chromium trioxide, chromic acid, oligomers of chromic acid and dichromic acid,
dichromic acid, sodium dichromate, potassium dichromate, ammonium dichromate, potassium
chromate, sodium chromate
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packaging of chemical agents and mixtures to the UN Globally Harmonized System. It
complements the REACH Regulation and replaces the current system.
The regulation requires companies to appropriately classify, label and package their
chemical agents and mixtures before placing them on the market. It aims to protect
workers, consumers and the environment by means of labelling which reflects possible
hazardous effects of a particular chemical.
Five OSH Directives (CAD, CMD, Pregnant Workers Directive, Young Workers
Directive, Safety Signs at Work Directive
199
) are directly related to the CLP Regulation
by providing a link to the hazard classification of chemical agents and mixtures
according to the CLP Regulation, and the resulting obligations for employers under the
OSH Directives (e.g. chemical agents and mixtures classified as carcinogens or
mutagens, category 1A or 1B are under the scope of the CMD).
14.2.3 Comparison of high level CMD and REACH provisions in relation to
occupational carcinogens
CMD
REACH
Scope includes process-generated chemical Scope does not include process-generated
agents
chemical agents
Sets 'minimum standards'. Member States Sets directly-acting harmonised standards
may maintain or implement more from which Member States cannot deviate
protective measures.
except in exceptional (and possibly time
limited) circumstances.
Risk assessment is, in all cases, specific to
the workplace where exposures occur
taking into account any specific processes,
operating
conditions,
workforce
characteristics, etc.
Risk assessment for majority of chemical
substances is undertaken by actors in the
supply chain (primarily manufacturers
and/or importers). May be specific to
specific workplace/s or more generic
applying to a larger number of workplaces.
Risk assessment takes into account Risks assessed and identified risk
aggregated exposure of workers to all management measures are specific to the
carcinogens at workplace level.
chemical substance or mixture being
manufactured, used and placed on the
market. REACH should result in improved
information being provided down the
supply chain to employers to inform their
OSH risk assessment.
EU OEL applies only in workplaces, and REACH covers all risks arising from given
so is targeted solely at occupational intrinsic properties of a substance which
exposures.
are not made subject to specific
derogations. These may include risks for
199
Council Directive 92/58/EEC of 24 June 1992 on the minimum requirements for the provision of safety
and/or health signs at work (ninth individual Directive within the meaning of Article 16(1) of Directive
89/391/EEC) (OJ L 245, 26.8.1992, p. 23
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workers, the public, consumers, and the
environment.
Occupational carcinogens must be REACH can complement a CMD OEL, in
substituted by a safer alternative where particular by strengthening the substitution
technically possible, then exposure must be principle and its full implementation.
eliminated where technically possible or
otherwise minimised. An EU OEL for a
given carcinogen does not alter this
expectation, but provides a compliance and
enforcement benchmark for employers,
workers and enforcers.
As social policy, under TFEU the social
partners play a key role in establishing
standards for worker protection by
adopting agreed positions on which
chemical agents should be made subject to
EU level OELs, at what level, and with
additional commentary where appropriate.
As an internal market Regulation social
partners have no formal role according to
the TFEU in policy or development of
legal standards. However, all stakeholders
are invited to provide comments during the
established public consultations.
OELs are established under and are an REACH is not intended to set OELs.
important part of CMD.
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15 A
NNEX
8 –
GENERAL INFORMATION ABOUT THE
REFERRED TO IN THE DOCUMENT
C
LASSIFICATION
SYSTEMS
15.1 Carcinogens
In this report, reference is mainly made to 2 systems to classify "agents" as carcinogens
or carcinogenic:
The EU classification, packaging and labelling system based on the CLP
Regulation (EC) No 1272/2008;
The classification system of the International Agency for Research on Cancer
(IARC)
15.1.1 Classification according to the CLP Regulation
The harmonised classification
200
of a chemical agent listed in Annex I to the CLP
Regulation and the resulting / associated labelling and packaging provisions is legally
binding for suppliers placing a chemical agent on the European market. An entry in
Annex I is established by the Commission via an amendment of the CLP Regulation,
following a scientific evaluation of the available information by the Risk Assessment
Committee of the European Chemicals Agency (ECHA). If a chemical agent is not listed
in Annex VI of the Regulation, suppliers must self-classify its chemical agent according
to the criteria established under the CLP Regulation before placing it on the market.
Following Article 2 ("Definitions") of the CLP Regulation, a 'chemical agent' is means "a
chemical element and its compounds in the natural state or obtained by any
manufacturing process, including any additive necessary to preserve its stability and any
impurity deriving from the process used, but excluding any solvent which may be
separated without affecting the stability of the chemical agent or changing its
composition".
Mixtures (composed of two or more chemical agents) are classified, labelled and
packaged based on the content of their classified components ("chemical agents") or
based on test results for the mixture as a whole following again the classification criteria
established under the CLP Regulation.
The exact criteria to classify chemical agents and mixtures according to the CLP
Regulation can be found in section 3.6 of that Regulation
201
. For the purpose of this
report it is important to notice, that the CMD applies 'only' to chemical agents and
mixtures meeting the criteria for classification as category 1A or 1B carcinogens set out
in Annex I to the CLP Regulation.
Category 1A carcinogens are chemical agents known to have carcinogenic
potential for humans; their classification is largely based on human evidence (so-
called epidemiological evidence)
Category 1B carcinogens are chemical agents presumed to have carcinogenic
potential for humans; their classification is largely based on animal evidence.
Suspected human carcinogens (Category 2 carcinogens according to the CLP Regulation)
are not under the scope of the CMD.
200
201
classification of chemical agents listed in Annex VI to the Regulation
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R1272-
20150601&qid=1447160631531&from=EN
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15.1.2 Classification according to IARC
The evaluations of carcinogenic risk are made by international working groups of
independent scientists and are qualitative in nature, and is published in the form of so-
called Monographs available on the IARC website
202
. Contrary to the EU system, IARC
evaluates also the carcinogenicity of occupational or environmental exposures, cultural or
behavioural practices, biological organisms and physical agents.
Even if the IARC approach is - like the EU approach - also hazard and not risk based
203
,
it goes beyond the chemical agent based approach of the EU by evaluating not only
chemical agents but also certain occupational exposure situations (for example
"Occupational Exposures in the Rubber Manufacturing Industry" or "Occupational
Exposure as a Painter"
204
).
Based on its evaluation, IARC classifies "agents" in 5 groups with regard to their
carcinogenicity to humans
205
:
Group 1 – The agent is carcinogenic to humans / This category is used when there
is
sufficient evidence of carcinogenicity
in humans.
Group 2A – The agent is probably carcinogenic to humans / This category is used
when there is
limited evidence of carcinogenicity
in humans and
sufficient evidence
of carcinogenicity
in experimental animals.
Group 2B – The agent is possibly carcinogenic to humans / This category is used
for agents for which there is
limited evidence of carcinogenicity
in humans and less
than
sufficient evidence of carcinogenicity
in experimental animals.
206
Group 3 – The agent is not classifiable as to its carcinogenicity to humans / This
category is used most commonly for agents for which the evidence of
carcinogenicity is
inadequate
in humans and
inadequate
or
limited
in experimental
animals.
Group 4 – The agent is probably not carcinogenic to humans / This category is used
for agents for which there is
evidence suggesting lack of carcinogenicity
in humans
and in experimental animals.
202
203
http://monographs.iarc.fr/ENG/Monographs/PDFs/index.php
A
hazard
is any source of potential damage, harm or adverse health effects on something or someone
under certain conditions at work; the
isk
is the chance or probability that a person will be harmed or
experience an adverse health effect if exposed to a hazard.
http://monographs.iarc.fr/ENG/Monographs/vol100F/index.php
The details of the objectives and scope of the IARC Monographs programme, the scientific principles
and the procedures used in developing a Monograph, the types of evidence considered and the scientific
criteria guiding the evaluations can be found in the preamble of each Monograph and on the following
web side: http://monographs.iarc.fr/ENG/Preamble/index.php
The terms
probably carcinogenic
and
possibly carcinogenic
have no quantitative significance and are
used simply as descriptors of different levels of evidence of human carcinogenicity, with
probably
carcinogenic
signifying a higher level of evidence than
possibly carcinogenic.
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204
205
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16 A
NNEX
9 – A
DDITIONAL
G
RAPHICAL
M
ATERIAL
16.1 1,2 Epoxypropane
Figure 4 - 1,2 Epoxypropane – Current national OELs vs. Option 2
60
mg/m
3
50
40
30
20
10
0
BG CY CZ IT LU MT PT EL FR RO DK HR IE SK UK PL AT NL SI BE EE HU LT SE DE ES FI LV
1,2-Epoxy-propane - current OELs
Option 2
16.2 1,3 Butadiene
Figure 5 - 1,3 Butadiene – Current national OELs vs. Option 2
120
mg/m
3
207
100
80
60
40
20
0
BG CY DE FR IT LU PT LV NL IE AT SI DK EL HR RO UK SK CZ BE ES MT PL FI EE HU LT SE
1,3-Butadiene - current national OELs
Option 2
207
Where the OELs have been provided as a range, the upper value has been used in the graph.
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Figure 6 - 1,3 Butadiene – Number of exposed workers
208
8.000
7.000
6.000
5.000
4.000
3.000
2.000
1.000
0
HR DE FR UK ES PL NL BE CZ RO SE HU FI AT DK BG PT IT EL IE SK SI LT LV EE LU CY MT
Number of workers exposed
16.3 2 Nitropropane
Figure 7 - 2 Nitropropane – Current national OELs vs. Option 2
209
40
35
30
25
20
15
10
5
0
CY CZ DE FR HU IT LU LV PL PT RO BE BG EL ES HR UK AT DK EE FI IE SI SK LT SE MT NL
2-Nitropropane - national OELs
Option 2
mg/m
3
208
209
Data for HR are not known.
ES, HR, UK have an OEL of 19 mg/m
3
, which is considered approximately equivalent to 18 mg/m
3
.
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Figure 8 - 2 Nitropropane –Number of exposed workers
210
16.000
14.000
12.000
10.000
8.000
6.000
4.000
2.000
0
Number of workers exposed
HR UK FR DE IT PL ES NL BE RO CZ SE IE EL AT HU DK FI LT PT BG SK SI LV EE CY LU MT
16.4 Acrylamide
Figure 9 – Acrylamide - Global polyacrylamide market, 2012-2019 (in 1,000 tonnes)
211
210
211
Data for HR are not known.
Source: http://www.transparencymarketresearch.com/polyacrylamide-market.html
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Figure 10 – Acrylamide - Current national OELs vs. Option 2
212
0,35
mg/m
3
0,3
0,25
0,2
0,15
0,1
0,05
0
CY CZ DE IT LU PT EL FI FR HR UK LV NL PL AT SI MT BE BG DK EE ES HU IE LT RO SK SE
Acrylamide - national OELs
Option 2
Figure 11 – Acrylamide - Number of exposed workers
213
12.000
Number of workers exposed
10.000
8.000
6.000
4.000
2.000
0
HR DE UK FR ES PL IT NL RO SE BE HU CZ EL PT DK AT BG FI SK IE LT SI LV EE CY LU MT
212
213
Where the OELs have been provided as a range, the upper value has been used in the graph.
Data for HR not available.
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16.5 Hardwood dust
Figure 12 – Hardwood dust - Current national OELs vs. EU OEL and Option 2
6
mg/m
3
5
4
3
2
1
0
BG CY ES FI HR HU IE IT LT LU LV MT PT RO SI SK UK EL BE AT CZ DE EE NL PL SE DK FR
Hardwood dust - national OELs
Option 2
Current EU OEL
Figure 13 – Hardwood dust - Number of exposed workers
214
700.000
600.000
500.000
400.000
300.000
200.000
100.000
0
BG HR RO DE ES UK IT PL FR CZ NL PT HU AT EL DK FI SK SE IE LT BE LV SI EE CY MT LU
Number of workers exposed
214
Data for BG, HR and RO not available.
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16.6 Chromium VI
Figure 14. Overview of Chromium Valence State in Chromium Applications
Source: HSE (2007) Human Health Risk Reduction Strategy for Chromates in IOM (2011) Hexavalent
Chromium, pp. 4
Figure 15 – Chromium VI - Current national OELs vs. Option 2
215
2,5
mg/m
3
2
1,5
1
0,5
0
DE
HU
IT
LU
PT
CY
SI
EL
PL
AT
SK
BG
CZ
FI
HR
RO
UK
BE
ES
IE
MT
NL
EE
LV
DK
LT
SE
FR
Chromium (VI) compounds
Option 2 (0.025)
215
Where the OELs have been provided as a range, the upper value has been used in the graph.
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Figure 16 - Chromium VI - Number of exposed workers
216
200.000
180.000
160.000
140.000
120.000
100.000
80.000
60.000
40.000
20.000
0
Number of workers exposed
HR DE IT ES FR UK PL RO CZ NL SE PT HU AT BE BG DK EL SK FI SI LT IE LV EE LU CYMT
16.7 Ethylene oxide
Figure 17 - The Global Ethylene Trade
216
Data for HR not available.
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Figure 18 – Ethylene oxide - Current national OELs vs. Option 2
100
90
80
70
60
50
40
30
20
10
0
DE IT LU PT CY EL IE HR UK AT BG EE LT SE SI SK FR MT BE DK ES FI HU RO CZ LV PL NL
mg/m
3
Ethylene oxide - national OELs
Option 2
Figure 19 – Ethylene oxide - Number of exposed workers
217
3.500
3.000
2.500
2.000
1.500
1.000
500
0
HR DE UK FR ES NL PL SE BE RO DK CZ PT AT HU IT FI EL IE BG SK LT SI LV EE LU CY MT
Number of workers exposed
217
Data for HR not available.
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16.8
o-Toluidine
Figure 20 -
o-Toluidine
- Current national OELs vs. Option 2
2,5
ppm
2
1,5
1
0,5
0
BG CY CZ DE EE HU IT LT LU NL PL PT RO SE SK MT BE DK EL FI FR ES HR IE UK AT LV SI
o-Toluidine - national OEL
Option 2
Figure 21 -
o-Toluidine
- Number of exposed workers
218
1.400
Number of workers exposed
1.200
1.000
800
600
400
200
0
HR DE FR UK IT ES PL NL BE RO SE CZ HU DK PT AT EL BG FI IE SK SI LT LV EE LU CY MT
218
Data for HR not available.
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16.9 Refractory Ceramic Fibres (RCF)
Figure 22 – Refractory Ceramic Fibres (RCF) - Current national OELs vs. Option 2
219
2,5
f/ml
2
1,5
1
0,5
0
HR BG DE EE EL FR IT LT LU LV PT RO SI HU CY DK IE UK PL SK AT BE ES NL CZ MT FI SE
RCF
Option 2
16.10 Respirable Crystalline Silica (RCS)
Figure 23 - Occupational inhalation exposure to crystalline silica (quartz dust) in Finland in 1950,
1970, 1990 and 2008 and predicted for 2020, as measured by four different metrics of exposure
220.
219
Where the OELs have been provided as a range, the upper value has been used in the graph.National
OELs of CY, HU and SK have been converted from mg/m
3
to f/ml. The original values are: CY – 10
mg/m
3,
HU – 5-10 mg/m
3,
SK – 4 mg/m
3
Proportional values as compared with 1950 (baseline = 100).
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Figure 24 - Respirable Crystalline Silica (RCS) - Current national OELs vs. Option 2
221
1,2
mg/m
3
1
0,8
0,6
0,4
0,2
0
DE LV SI IT LU PT PL CY EL AT HU CZ DK IE SK UK RO SE BE EE FR LT NL BG ES FI HR MT
RCS - national OELs
Option 2
Figure 25 - Respirable Crystalline Silica (RCS) - Number of exposed workers
222
1.600.000
1.400.000
1.200.000
1.000.000
800.000
600.000
400.000
200.000
0
HR ES DE FR UK PL IT RO PT CZ NL EL SE AT BE HU BG DK FI LT SK IE SI LV EE LU CY MT
Number of workers exposed
221
In the case of countries with different OELs set for the different types of RCS (quartz, cristobalite,
tridymite), the lowest OEL is represented in the graph. For instance, the quartz OELs of Belgium,
France, Greece and Estonia are set at 0.1 mg/m
3
.
Data for HR not available. Where the OELs have been provided as a range, the upper value has been
used in the graph.
157
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16.11 Vinyl Chloride Monomer (VCM)
Figure 26 - Vinyl Chloride Monomer (VCM) - Current national OELs vs. EU OEL and Option 2
9
8
7
6
5
4
3
2
1
0
ES UK BE CY DE HR HU IE IT LT LU LV MT NL PT RO SI SK FI EL CZ AT PL DK EE FR BG SE
Vinyl chloride - national OELs
Option 2
Current EU OEL
mg/m
3
16.12 Bromoethylene (vinyl bromide)
Figure 27 - Bromoethylene (vinyl bromide) – Current national OELs vs. Option 2
25
mg/m
3
20
15
10
5
0
AT BG CY CZ DE EE EL FR HU IT LT LU LV PT SE SI UK SK RO DK HR MT FI ES IE BE PL NL
Bromoethylene - national OELs
Option 2
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16.13 Hydrazine
Figure 28- Hydrazine –– Current national OELs vs. Option 2
0,14
mg/m
3
0,12
0,1
0,08
0,06
0,04
0,02
0
SE PT NL MT LU IT HU DE CY SK SI FI EL AT RO LV LT FR EE BG PL CZ UK HR ES DK BE IE
Hydrazine - national OELs
Option 2
Figure 29- Hydrazine - Number of exposed workers
223
450.000
400.000
350.000
300.000
250.000
200.000
150.000
100.000
50.000
0
HR DE FR UK PL IT ES RO CZ HU NL BG SE AT SK BE PT DK LT FI IE SI LV EL EE LU CYMT
Number of workers exposed
223
Data for HR not available.
159
 kom (2016) 0248 (forslag) - COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a Directive of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work
17 A
NNEX
10 – A
BBREVIATIONS USED
ACSH
CAD
CLP
CMD
CMR
DNEL
ECHA
EIG
GIG
IARC
mg/m
3
NEPSi
OEL
OSH
PGSs
ppb
ppm
RAC
RCF
RCS
REACH
REFIT
SCOEL
SMEs
STEL
SWD
SVHC
TFEU
TWA
UN
VCM
YYL
Advisory Committee on Safety and Health at Work
Chemical Agents Directive (Directive 98/24/EC)
Classification, Labelling and Packaging Regulation (Regulation (EC) No
1272/2008)
Carcinogens and Mutagens Directive (Directive 2004/37/EC)
carcinogenic, mutagenic, and chemical agents toxic to reproduction
Derived No Effect Level
European Chemicals Agency
Employers Interest Group
Government Interest group
International Agency for Research on Cancer
milligram per cubic metre
Agreement on Workers' Health Protection Through the Good Handling
and Use of Crystalline Silicas and Products Containing it
Occupational Exposure Limit Value
Occupational Safety and Health
Process Generated Substances
part per billion
parts per million
Risk assessment Committee of ECHA
Refractory Ceramic Fibres
Respirable Crystalline Silica
Regulation on Registration, Evaluation, Authorisation and Restriction of
Chemicals (Regulation (EC) No 1907/2006)
Regulatory Fitness and Performance Programme
Scientific Committee on Occupational Exposure Limits
Small and Medium Sized Enterprises
Short Term Exposure Limit
Staff Working Document
Substance of Very High Concern
Treaty on the Functioning of the EU
Time-weighted average
United Nations
Vinyl Chloride Monomer
Years of Life Lost
160
 kom (2016) 0248 (forslag) - COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a Directive of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work
WIG
WHO
WPC
Workers Interest Group
World Health Organisation
Working Party 'Chemicals at the Workplace'
161