EN Official Journal of the European Union C 288/56

Opinion of the European Economic and Social Committee on the ‘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(2017) 11 final — 2017/0004 (COD))

(2017/C 288/07)

Rapporteur: Marjolijn BULK

Consultation European Parliament, 19.1.2017 Council, 16.2.2017 Legal basis Article 304 of the Treaty on the Functioning of the European Union Plenary Assembly decision 24.1.2017 Section responsible Employment, Social Affairs and Citizenship Adopted in section 3.5.2017 Adopted at plenary 31.5.2017 Plenary session No 526 Outcome of vote (for/against/abstentions) 149/0/3

1. Conclusions and recommendations

1.1 The EESC welcomes the opening of the process to revise the carcinogens directive and is willing to contribute to this important debate.

1.2 The EESC urges the Commission to carry out an impact assessment of a possible extension to the scope of application of the Carcinogens and Mutagens Directive (CMD) to substances which are toxic to reproduction.

1.3 The Committee strongly recommends that the revisions of the CMD and amendments planned for 2018 pay greater attention to occupational carcinogenic exposures affecting women.

1.4 The EESC considers it important for the Commission to improve upon a common methodology for the adoption of binding occupational exposure limit value (BOELs) in the CMD, in consultation with social partners, Member States and other stakeholders.

1.5 BOELS must be defined on the basis of scientific and statistical evidence, taking into account different factors such as feasibility and the possibilities for measuring exposure levels. A risk-based approach is used in the Netherlands and Germany and helps to define BOELs by taking into account the level of risk as the primary determinant of a social compromise.

1.6 The EESC considers it necessary to set up programmes to propose life-long health surveillance for all persons that have been exposed to workplace carcinogens in the framework of national social security or public health systems.

1.7 The EESC stresses that in order to improve the protection of workers from carcinogens, mutagens and reprotoxic substances at work, Member States should ensure that labour inspectorates have sufficient financial and human resources to carry out their duties.

1.8 The EESC supports the common position of Europe’s social partners and recommends that a BOEL be adopted for formaldehyde.

1.9 The EESC recommends that when establishing a legal definition of diesel engine exhausts (DEE), the Commission take into account the SCOEL finding regarding DEE.

2. Background of the proposal

2.1 Cancer is the main cause of mortality due to working conditions. In 2013, there were an estimated 1,314 million cancer deaths in the EU. More than 100 000 deaths in the EU resulted from occupational-related cancer. It is the first cause of work-related deaths in the EU. Around twenty million EU workers are exposed to carcinogens at work. A study published in 2015 by the Dutch National Institute for Public Health and the Environment (1) estimates the annual cost of these occupational cancers at EUR 334 billion.

2.2 Workers’ protection legislation deals with occupational cancer in a number of directives. The general obligations of the framework directive (2) of 1989 apply to all the risks and define general measures which have to be implemented in the workplace. The chemical agents directive (3) applies to all dangerous chemicals. The asbestos directive (4) takes into account some specific needs for the prevention of asbestos-related diseases. The most important specific piece of legislation is the carcinogens directive adopted in 1990.

2.3 The CMD sets general minimum requirements. Employers must identify and assess risks 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 substitution is not technically possible, chemical carcinogens must again as far as it is technically possible be manufactured and used in a closed system to prevent exposure. Where this itself is not technically possible, worker exposure must be reduced to as low a level as is technically possible.

2.4 In addition to these general minimum requirements, the CMD sets occupational exposure limit values (OELs) for particular carcinogens and mutagens as an integral part of the mechanism for protecting workers. Concrete BOELs for specific chemical agents are laid down in Annex III to the CMD. Currently, this annex has defined BOELs for only three substances or process-generated exposures. These BOELs cover only a small percentage of workers exposed to CMRs.

2.5 In 2016, the European Commission announced that the CMD would be revised in three phases. It adopted an initial proposal in May of that year which is now being discussed in the European Parliament and the Council of Ministers. A second proposal was adopted in January 2017 and a third is scheduled for 2018.

2.6 The revision of the CMD is an ongoing process. The first proposal revised two existing BOELs and adopted eleven new ones. In its Ulvskog report (5), the European Parliament supported the CMD revision process and called, among other things, for the broadening of its scope to include reprotoxic substances, the introduction of stricter occupational exposure limit values for six of the substances and the setting of a transitional limit value so as to give employers additional time for implementation. The European Parliament also stressed the point that the 2017 and 2018 revisions of Annex III to Directive 2004/37/EC should include but not be limited to substances, mixtures and processes such as diesel engine exhaust, formaldehyde, cadmium and its compounds, beryllium and its compounds, nickel compounds, arsenic and its compounds and acrylonitrile. A very large majority of political groups supported the compromise proposed by the European Parliament.

2.7 The main aim of the second proposal is to adopt five new BOELs. Although complex PAH (polycyclic aromatic hydrocarbon) mixtures and used engine oils appear in the annex defining the directive’s scope of application, no limit values have been set for these two carcinogens. Drawing on its own analysis, the Commission decided that no action should be taken at this stage on five carcinogens (6).

3. General comments

3.1 The scope of application of the CMD is at present limited to carcinogens and mutagens; a possible extension to substances which are toxic to reproduction should be considered. According to EU-OSHA: ‘The effects of occupational exposure on the reproductive system of men and women may become manifest as alterations in sex hormone levels, diminished libido and potency, menstrual disorders, premature menopause, delayed menarche, ovarian dysfunction, impairment of semen quality, and reduced male and female fertility. Toxic exposures can cause direct cell damage in the developing sperm and eggs. Maternal exposure during pregnancy may disturb foetal development (…). Toxic exposures can induce many wide-ranging effects, e.g. foetal death, intrauterine growth retardation, preterm birth, birth defects, postnatal death, disturbances in cognitive development, and changes in immunological sensitivity, or childhood cancer. The mother’s exposure at work to chemicals may also cause contamination of her breast milk. Some chemicals with hormonal activity, known as endocrine disrupters, may alter the function of the endocrine system and consequently cause adverse reproductive effects, e.g. poor semen quality and damaged reproductive tissues in men and some gynaecological medical conditions in women.’

3.1.1 Under REACH and several specific pieces of legislation (on cosmetic products, biocides and pesticides), carcinogens, mutagens and reprotoxic substances are treated in an umbrella group of substances of very high concern. They share some common characteristics, amongst which are their acute health impact, the difficulty of risk perception (since the consequences of exposure often appear after a long latency period), the difficulty of risk management and problems linked with ‘cocktail effects’ that is, exposure to two or more different substances or processes. The national legislation in several Member States has adopted such an approach with the support of social partners at national level. The EESC urges the Commission to carry out an impact assessment on a possible extension of the scope of application of the Carcinogens and Mutagens Directive (CMD) to substances which are toxic to reproduction.

3.2 The EU strategy against work-related cancers should pay more attention to women.

3.2.1 The pattern of exposure and the pattern of cancer locations may vary between men and women. Breast cancer, for instance, is a very rare disease for men, whereas it is the most common cancer for women. A range of occupational exposures may contribute to breast cancer.

3.2.2 The Committee strongly urges the Commission to give more systematic consideration to occupational carcinogenic exposures affecting women in the revision of the Directive and amendments planned for 2018. Many types of work in which women are concentrated (health, cleaning, hairdressing and so on) involve exposures to carcinogenic substances that are neglected. There is a need to define criteria for the identification and classification of endocrine disruptors which contribute to some cancers. Prevention should be strengthened in the use of cytostatic products (i.e., chemotherapeutics) in the health professions. Although ionising radiations do not fall within the scope of the present opinion, the EESC strongly urges the need to strengthen other directives and in particular Directive 2013/59/Euratom.

3.3 There is broad agreement among stakeholders about the role and the importance of BOELs. BOELs are important because they help to reduce the risk, even when there is no safe level of exposure. They must be set at an adequate level, taking into account the scientific evidence and feasibility aspects.

3.3.1 However, there is no uniform methodology in the EU for deriving BOELs. Presently, the Commission operates on a ‘case-by-case’ basis. Transparency and consistency could for the most part be improved. Some BOELs are good, while others provide insufficient protection. The EESC considers that where health and human lives are concerned, ambitions must be up to the challenge.

3.3.2 Another factor is that Member States have different approaches. Some of them have defined BOELs for more than a hundred different CMRs, others for fewer than ten. The level of these BOELs can differ from one country to another. This creates difficulties for companies operating in different countries with variable standards and could in some cases result in unfair competition.

3.3.3 The EESC considers it important, therefore, for the Commission to define a methodology for the adoption of BOELs in the CMD. Such a process should involve a broad consultation with the social partners, Member States and other stakeholders, including NGOs. National experience helps to define good practices. For the EESC, two elements should be particularly considered:

3.3.3.1 Firstly, the consistency of BOELs, in order to avoid a situation in which workers exposed to certain substances might be at a much higher risk of cancer than workers exposed to other substances. In Germany and the Netherlands, there is support among social partners for a risk-based approach. This helps to define BOELs by taking into account the risk level as the primary determinant of a social compromise;

3.3.3.2 Secondly, BOELs must be defined on the basis of scientific evidence. They must take into account different factors, such as feasibility and the possibilities for measuring exposure levels. In order to help employers prioritise their prevention measures, they should explicitly refer to the level of risk associated with the exposure level.

3.4 In most cases, there is a long latency period between exposure and cancer. The EESC considers it necessary, therefore, to protect exposed workers or workers who are at risk of exposure by offering life-long health surveillance set up in the framework of social security or national health systems for all exposed workers.

3.5 The EESC recommends that more efforts should be focused on the fields of scientific and statistical studies. Occupational cancer may also be caused by: stress; work organisational factors e.g. shift work, etc. More attention and funding should be paid to researching the consequences and potential synergy of combined exposure to different factors such as chemicals and biological or physical agents, chemicals and work organisation, etc.

3.6 The EESC stresses that one of the main tasks in the area of protecting workers from carcinogens, mutagens and reprotoxic substances in the workplace is to strengthen control over the implementation and application of the CMD. Member States should ensure that labour inspectorates have sufficient financial and human resources to carry out their duties while helping companies, and in particular SMEs, to comply with these new provisions. They should strengthen their cooperation with the European Agency for Safety and Health at Work, which has developed different tools that might improve the quality of workplace prevention. One of those tools is OIRA (Online Interactive Risk Assessment), a web platform that enables the creation of sectoral risk assessment tools in any language in an easy and standardised way.

4. Specific comments

4.1 The second CMD proposal introduces BOELs for five additional carcinogenic substances.

4.1.1 Epichlorohydrine (ECH) is a non-threshold carcinogen. The number of exposed workers in the EU stands at 43 813. The Commission proposes a BOEL of 1,9 mg/m3. Fifteen Member States will need to introduce (7) or update (8) their OEL to bring it down to 1,9 mg/m3. Around 69 % of exposed workers are estimated to work in those fifteen Member States and would consequently benefit from improved legal protection as a result of the introduction of this BOEL. The EESC considers that the proposed BOEL would contribute to reducing the work-related cancer burden.

4.1.2 Ethylene dibromide (EDB) is a genotoxic carcinogen without a threshold. Fewer than 8 000 EU workers are estimated to be potentially exposed to 1,2-dibromoethane. The Commission proposes a BOEL of 0,8 mg/m3 (0,1 ppm). Twenty Member States will need to introduce (11) or update (9) their OEL to bring it down to 0,8 mg/m3. 81 % of exposed workers are estimated to work in those twenty Member States and would consequently benefit from improved legal protection as a result of the introduction of this BOEL. The additional costs for companies (among them micro- and small enterprises) are expected to be very low. The EESC considers that the proposed BOEL would contribute to reducing the work-related cancer burden.

4.1.3 Ethylene dichloride (EDC) is classified as a carcinogen 1B according to CLP. Fewer than 3 000 workers are potentially exposed in Europe (7). The Commission proposes a BOEL of 8,2 mg/m3 of 2 ppm. Twenty-three Member States will need to introduce (5) or update (18) their OEL to bring it down to 2 ppm, so it is expected that a large proportion of exposed workers could benefit from improved legal protection. The EESC considers that the proposed BOEL would contribute to reducing the work-related cancer burden.

4.1.4 4,4’-methylenedianiline (MDA) is a genotoxic carcinogen. It is estimated that approximately 70-140 people are exposed to airborne MDA in the chemical industry. The number of people affected by dermal exposure is considerably higher and expected to be in the range between 390 000 and 3,9 million workers (8). The Commission proposes a BOEL of 0,08 mg/m3. Twenty-three Member States will have to introduce (12) or update (11) their OEL to bring it down to 0,08 mg/m3. The EESC considers that the proposed BOEL would contribute to reducing the work-related cancer burden.

4.1.5 Trichloroethylene (TCE) is classified as a group 2A carcinogen by the International Agency for Research on Cancer (hereafter: IARC) and as a Category 1B carcinogen in the EU under CLP. It is estimated that approximately 74 000 workers in the EU are potentially exposed to TCE. The Commission proposes the combination of a BOEL of 54,7 mg/m3 of 10 ppm and a short-term exposure limit (hereafter: STEL) of 164,1 mg/m3 of 30 ppm. Of the twenty-two Member States which already have a national BOEL for TCE in place, sixteen have also adopted a STEL. Seventeen Member States will have to introduce (6) or update (11) their BOEL to bring it down to 54,7 mg/m3 (10 ppm). Nearly 74 % of exposed workers are estimated to work in those seventeen Member States and would consequently benefit from improved legal protection thanks to the introduction of the OEL. The EESC notes that a lower BOEL for trichloroethylene has been implemented in a number of Member States and is supported by employers’ organisations and trade unions. At EU level, a lower BOEL should be envisaged in order to reduce the work-related cancer burden.

4.2 Although complex polycyclic aromatic hydrocarbon (PAH) mixtures and used engine oils appear in the annex defining the scope of application of the directive, no limit values have been set for these two carcinogens.

4.2.1 Complex polycyclic aromatic hydrocarbon (PAH) mixtures with benzo[a]pyrene as an indicator. PAHs are a large class of organic compounds. The EESC considers that the proposed measure would contribute to reducing the work-related cancer burden.

4.2.2 Mineral Oils as Used Engine Oils. Exposure to mineral oils as used engine oils may cause skin cancer. The number of workers exposed is estimated at 1 million, employed mostly in maintenance and repair of motor vehicles. The EESC considers that the proposed measure would contribute to reducing the work-related cancer burden.

5. Further substances or processes to be added

5.1 Formaldehyde (FA). The Commission has not proposed a BOEL for formaldehyde (FA). In 2009, the IARC concluded there was sufficient evidence in humans of a causal association of formaldehyde with myeloid leukaemia. The available information for FA is adequate for deriving a health-based OEL, 8-hour time-weighted average (TWA) and STEL. Based on the available data, SCOEL derives an Occupational Exposure Limit Value of 0,3 ppm (8h TWA) with a STEL of 0,6 ppm. Following this, the Advisory Committee on Safety and Health at Work (ACSHW) also decided to recommend this limit value to the Commission. In 2016, European social partners asked the Commission to include the SCOEL’s proposed health based values as a BOEL for this chemical (9). The EESC supports this common position and considers that a BOEL should be adopted.

5.2 Diesel engine exhausts (DEE). In 2012, the International Agency for Research on Cancer (IARC) categorised all diesel engine exhaust emissions as Class 1 carcinogens (proven human carcinogens). According to the Commission, over three million workers in the European Union are exposed to diesel engine exhaust emissions at work. The total number of workers exposed to these fumes during at least part of their working career amounted to twelve million in 2010, potentially rising to twenty million by 2060. The Commission’s Impact Assessment states that the lack of legislation prohibiting exposure to diesel engine exhaust at work will result in 230 000 deaths in the EU between 2010 and 2069.

5.2.1 The Commission’s main argument for excluding DEE from Annex I and Annex III of the CMD is that it would be difficult to find a legal definition to distinguish between new engines and old engines. In the EESC’s view, the aim of the CMD is not to define technical standards for engines, but to establish a legal definition of DEE as a carcinogenic process according to scientific evidence and the evaluation of the IARC. In the workplace workers might be exposed to diesel engine exhaust fumes from several engines complying with different exposure standards. Other factors play an important role in the characterisation of the exposure: combustion temperatures and maintenance and cleaning of the engines. A BOEL could be defined that takes into account the air concentration of elemental carbon. The EESC considers that the following finding from the SCOEL should be taken into account: ‘Although toxicological data supports a threshold (possibly at 0,02 mg DEP/m3 or below, corresponding to 0,015 mg EC/m3), epidemiological data suggests significant cancer risks already at and below these exposure levels. Therefore, an occupational exposure limit that would be adequately protective for workers cannot be established on the basis of the current available data and analysis. However, both toxicological and human epidemiological data are further gathered and evaluated’ (10).

Brussels, 31 May 2017. The President of the European Economic and Social Committee Georges DASSIS

(1) Dutch National Institute for Public Health and the Environment (RIVM), Work related cancer in the European Union. Size, impact and options for further prevention, 2015.

(2) Measures to improve the safety and health of workers at work, Council Directive 89/391/EEC (OJ L 183, 29.6.1989, p. 1).

(3) Protection of the health and safety of workers from the risks related to chemical agents at work, Council Directive 98/24/EC (OJ L 131, 5.5.1998, p. 11).

(4) Protection of workers from risks related to exposure to asbestos at work, Directive 2009/148/EC of the European Parliament and of the Council (OJ L 330, 16.12.2009, p. 28).

(5) Ulvskog report

(6) Beryllium and inorganic beryllium compounds, Hexachlorobenzene (HCB), Diesel engine exhaust (DEE), Rubber process dust and fumes (RPDF) and 4,4’-Methylene-bis-(2 chloraniline) (MOCA).

(7) 2009 data.

(8) Institute of Medicine (IOM, renamed HDM in 2016) Research project P937/9 on 4,4’-Methylenedianiline, May 2011.

(9) EPF, ETUC, EAMA, ETRMA, Formacare, and EPRA Request to include Formaldehyde in Annex III of the Carcinogens and Mutagens Directive 2004/37/EC, 15 July 2016.

(10) SCOEL opinion No 403, 2016.