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From · Plenary report · 17 Apr 2026 A-10-2026-0100 on the proposal for a directive of the European Parliament and of the Council amending Directive 2004/37/EC as regards the addition of substances and setting limit values in its Annexes I, III and IIIa

To · Adopted text · 6 Oct 2026 TA-10-2026-0321 Protection of workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work

These two texts have too little in common to be compared paragraph by paragraph — they are different documents rather than versions of one (for example one group's motion against the joint text that was adopted).

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~~DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION~~

P10_TA(2026)0321

on the proposal for a directive of the European Parliament and of the Council amending Directive 2004/37/EC as regards the addition of substances and setting limit values in its Annexes I, III and IIIa

Protection of workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work

~~(COM(2025)0418 – C100180/2025 – 2025/0232(COD))~~

Committee on Employment and Social Affairs

PE781.362

European Parliament legislative resolution of 6 October 2026 on the proposal for a directive of the European Parliament and of the Council amending Directive 2004/37/EC as regards the addition of substances and setting limit values in its Annexes I, III and IIIa (COM(2025)0418 – C10-0180/2025 – 2025/0232(COD))

(Ordinary legislative procedure: first reading)

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

– having regard to the opinion of the European Economic and Social Committee of 23 October 2025,

– after consulting the Committee of the Regions,

– having regard to the provisional agreement approved by the committee responsible under Rule 75(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 22 July 2026 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

– having regard to Rule 60 of its Rules of Procedure,

3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Recital 1: (1) To improve the protection of workers against risks from exposure to carcinogens, mutagens or reprotoxic substances at the place of work and ensure the same minimum level of protection across the Union, regular updates of Directive 2004/37/EC of the European Parliament and the Council3 are necessary. Occupational exposure limit values should be established or revised in light of available information, including up-to-date scientific evidence and technical data, and should be based on a thorough assessment of the socio-economic impact and feasibility factors. It is essential that such information include opinions of the Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA) established by Regulation (EC) No 1907/2006 of the European Parliament and of the Council4 and opinions of the Advisory Committee on Safety and Health at Work (ACSH)5. Those opinions provide the necessary scientific evidence to substantiate any Commission proposal to amend Directive 2004/37/EC. Moreover, they are based on practical experience and the realities of the workplace across the Union and reflect a broad consensus. Rules based on such opinions can therefore be implemented in the Member States in practice. Opinions of the ACSH, which are the outcome of tripartite consensus, are of particular importance in this context. In the absence of opinions of the RAC or of the ACSH, the Commission should set out, in its proposal, the reasons underpinning it, on the basis of scientific e…

P10_TC1-COD(2025)0232

Recital 2: (2) Directive 2004/37/EC covers substances and mixtures which meet the criteria for classification as a category 1A or 1B carcinogen, mutagen or reprotoxic set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council6 as well as substances, mixtures and processes referred to in Annex I to that Directive. Robust scientific evidence is to be provided for any new addition to the list of substances, mixtures and processes referred to in that Annex I to demonstrate that these substances, mixtures and processes fall within the scope of Directive 2004/37/EC, based on available valid scientific sources such as the ECHA, the International Agency for Research on Cancer (IARC) and national bodies, paying particular attention to peer-reviewed published literature on those substances, mixtures and processes. It remains essential that the Commission accelerates the procedure for assessment of hazardous substances, mixtures and processes, with a view to setting occupational exposure limit values for a greater number thereof and ensuring the highest level of protection for workers, including by increasing the scientific and administrative capacity of all Union bodies involved.

Position of the European Parliament adopted at first reading on 6 October 2026 with a view to the adoption of Directive (EU) 2026/… 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, mutagens or reprotoxic substances at work

Recital 2 a (new): (2a) Workers may be more exposed and more vulnerable to different types of substances depending on their gender, and this should be considered in occupational health and safety research, scientific studies and in the opinions of the RAC and ACSH. It is essential that gender mainstreaming is an integral part of the development of all occupational safety and health policies and prevention strategies at Union level and that gender-specific vulnerability and differences in exposure patterns, physiological susceptibility and health outcomes are taken into account in future revisions of Directive 2004/37/EC, especially when setting occupational exposure limits, while ensuring the participation of men and women in the labour market.

(Text with EEA relevance)

Recital 2 b (new): (2b) Certain substances covered by Directive 2004/37/EC are used in sectors of strategic importance to the Union. While advancing the industrial transition, stimulating the circular economy and maintaining and enhancing the international strategic autonomy in raw materials are all priorities of the Union, it is also essential to ensure that all workers receive a high and comparable level of protection against health risks related to occupational exposure, in line with the objectives of ensuring a high level of human health protection and, preventing physical illness and diseases, and obviating sources of danger to physical health laid down in Article 168(1) TFEU. Principle 10 of the European Pillar of Social Rights also provides for the right of workers to a high level of protection of their health and safety at work, which includes protection from the exposure to carcinogens, mutagens and reprotoxic substances at the place of work. In this regard, the process for setting occupational exposure limit values takes into account not only scientific and health considerations, but also socioeconomic aspects, which in some cases justifies the establishment of transitional periods. For certain substances, the ACSH may recommend that further revisions be considered to allow, in the light of evolving scientific, technical, and socio-economic knowledge, the adoption of solutions that guarantee a level of protection more closely aligned with acceptable levels of risk to workers' health.

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Recital 3: (3) The IARC classified welding fumes as ‘carcinogenic to humans’ (Group 1 of the IARC classification). According to the ECHA scoping study7, welding fumes and fumes from other processes that generate fumes in a similar way, are complex and may include carcinogens, mutagens or reprotoxic substances, such as chromium(VI) compounds, nickel compounds, cadmium and its inorganic compounds. The complexity and heterogeneity of welding and other fumes, together with the absence of harmonised classification in the Regulation (EC) 1272/2008, contribute to a lack of clarity on their possible dangerousness for workers, and therefore a lack of appropriate risk management measures at the workplace. Addressing that absence of classification for welding fumes at Union level would ensure more legal clarity in terms of the application of Directive 2004/37EC. It is therefore appropriate, in line with the opinion of the ACSH8, to include in Annex I to Directive 2004/37/EC work involving exposure to welding fumes and fumes from other processes that generate fumes in a similar way, containing substances that meet the criteria for a substance or mixture which meets the criteria for classification as a category 1A or 1B carcinogen, mutagen or reprotoxic set out in Annex I to Regulation (EC) No 1272/2008. That ACSH opinion also identified the need for further measures to reduce health effects of exposure to particulates from welding fumes and other sources, including the establishment of a general du…

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 153(2), point (b), in conjunction with Article 153(1), point (a), thereof,

Recital 6: (6) For cobalt and its inorganic compounds, it is foreseeable that it will be difficult to comply with a limit value of 0,01 mg/m³ for the inhalable fraction and 0,0025 mg/m³ for the respirable fraction in the short term. It is therefore appropriate to introduce a transitional period of six years after entry into force of this Directive, during which the limit values of 0,02 mg/m³ (inhalable fraction) and 0,0042 mg/m³ (respirable fraction) should apply. Some sectors may face difficulties in complying with the occupational exposure limits (OELs). In those sectors it is necessary that respiratory protective equipment is available and used by workers when the lower limit values cannot be complied with otherwise, to ensure that workers are appropriately protected. It is necessary that all Member States implement the rules set out in Article 5, in accordance with the hierarchy of controls, to eliminate or minimise workers’ exposure in a consistent manner, in order to ensure a level playing field.

Having regard to the proposal from the European Commission,

Recital 6 a (new): (6a) Cobalt is used in several sectors of strategic importance to reach the goals set out in the European Green Deal and Union Climate Law, such as the batteries sector. Cobalt is a hazardous metal posing serious health risks to workers, such as respiratory problems, heart, thyroid, liver or kidney damage and potential cancer and its consumption is projected to rise by approximately 330 % by 2050 as a result of the green transition1a, making it particularly important to ensure a high level of protection of workers’ health and safety. OELs for Cobalt and its inorganic compounds are thus necessary to help prevent long-term effects on the health and wellbeing of workers and to support the attractiveness, competitiveness and thus long-term sustainability of the cobalt industry in the Union. / 1a Commission Staff Working Document, Impact Assessment Report accompanying the Proposal for a Directive amending Directive 2004/37/EC, SWD(2025) 192 final https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52025SC0192#:~:text=Document%2052025SC0192,SWD/2025/192%20final

After transmission of the draft legislative act to the national parliaments,

Recital 6 b (new): (6b) Because of the harmful properties of cobalt and its inorganic compounds, relocation of cobalt-processing enterprises to third countries with less stringent occupational safety and health regulations needs to be avoided at all times.

Having regard to the opinion of the European Economic and Social Committee,

Recital 8 a (new): (8a) Isoprene meets the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and is therefore a carcinogen as defined in Directive 2004/37/EC. It is therefore appropriate, on the basis of the available information, including scientific and technical data, including the RAC1a and ACSH opinions, to establish a longterm occupational exposure limit value of 8,5 mg/m3 (3 ppm). / 1a https://echa.europa.eu/oels-activity-list/-/substance-rev/62301/term

After consulting the Committee of the Regions,

Recital 8 b (new): (8b) Short-term or single exposure to isoprene may cause irritation to the nose, throat, and lungs, and can lead to symptoms such as headache or dizziness. Chronic and high exposure may lead to liver cancer but also anaemia, degeneration of olfactory epithelium and degeneration of spinal cord white matter. While for the time being the exposure of workers is still low, a binding occupational exposure limit for isoprene is nevertheless needed to prevent potential risks arising in the future and to secure a level-playing field across Members States.

Acting in accordance with the ordinary legislative procedure,

Recital 9: (9) 1,4-dioxane meets the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and is therefore a carcinogen within the meaning of Directive 2004/37/EC. It is therefore appropriate, based on the available information, including scientific and technical data, including the RAC12 and ACSH opinions, to establish a long- and short-term occupational exposure limit value of 7,3 mg/m³ (2 ppm) and 73 mg/m³ (20 ppm), respectively, supplemented by a skin notation and a biological limit value of 45 mg HEAA in urine/g creatinine, measured at the end of exposure or shift.

Whereas:

Recital 9 a (new): (9a) Directive (EU) 2022/431 of the European Parliament and the Council1a extended the scope of Directive 2004/37/EC to include reprotoxic substances, including mercury and divalent inorganic mercury compounds, which were added to Annex III to Directive 2004/37/EC. Since not all divalent inorganic mercury compounds can be classified as reprotoxic substances, it is necessary to clarify that the limit value applies only to mercury and divalent inorganic mercury compounds that fall within the scope of Directive 2004/37/EC. The term ‘mercury and divalent inorganic mercury compounds including mercuric oxide and mercuric chloride (measured as mercury)’ should therefore be replaced by the term ‘mercury and divalent inorganic mercury compounds that fall within the scope of Directive 2004/37/EC (measured as mercury)’. / 1a Directive (EU) 2022/431 of the European Parliament and of the Council of 9 March 2022 amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (OJ L 88, 16.3.2022, p. 1).

(1) In order to improve the protection of workers against risks from exposure to carcinogens, mutagens or reprotoxic substances at the place of work and ensure the same minimum level of protection across the Union, regular updates of Directive 2004/37/EC of the European Parliament and the Council are necessary. Occupational exposure limit (OEL) values should be established or revised in light of available information, including up-to-date scientific evidence and technical data, and should be based on a thorough assessment of the socio-economic impact and feasibility factors. That information should, where available, include opinions of the Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA) established by Regulation (EC) No 1907/2006 of the European Parliament and of the Council and opinions of the Advisory Committee on Safety and Health at Work (ACSH) established by Council Decision of 22 July 2003. Those opinions provide necessary scientific evidence to substantiate any Commission proposal to amend Directive 2004/37/EC. Moreover, they are based on practical experience and the realities of the place of work across the Union and reflect a broad consensus. ACSH opinions, which are the outcome of tripartite consensus, are of particular importance in that context, and should be taken into account. In accordance with the Interinstitutional Agreement of 13 April 2016 on Better Law-Making, the Commission should ensure that its proposals are informed by robust evidence and comprehensive stakeholder involvement, and should systematically assess the economic, social and environmental impact of its proposals. Its proposals should respect the principles of subsidiarity and proportionality, in accordance with the Treaty on European Union (TEU) and the Treaty on the Functioning of the European Union (TFEU).

Recital 9 b (new): (9b) Directive (EU) 2022/431 of the European Parliament and of the Council of 9 March 2022 amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work requested the Commission to develop a definition for hazardous medicinal products, publish guidelines and establish an indicative list of hazardous medicinal products or the substances contained therein. While this work has been undertaken, no definition for hazardous medicinal products have to date been included in Union legislation. In order to ensure legal completeness and provide regulatory clarity on the matter, it is therefore appropriate to add such a definition in this Directive.

(2) Directive 2004/37/EC covers substances or mixtures which meet the criteria for classification as a category 1A or 1B carcinogen, mutagen or reproductive toxicant set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council, as well as substances, mixtures or processes referred to in Annex I to that Directive. Robust scientific evidence is to be provided for any new addition to the list of substances, mixtures and processes referred to in ▌ Annex I to Directive 2004/37/EC to demonstrate that those substances, mixtures and processes fall within the scope of that Directive ▌ , based on available valid scientific sources, such as the ECHA, the International Agency for Research on Cancer (IARC) and national bodies, paying particular attention to peer-reviewed published literature on those substances, mixtures and processes. To ensure the highest level of worker protection, the Commission should enhance its efforts to identify priority substances for setting limit values under that Directive on the basis of the best available information, including scientific and technical data, while making best use of current and future budgetary and administrative resources, taking into account scientific and administrative needs.

Recital 9 c (new): (9c) Workers in several sectors, including aviation ground operations, may be exposed to aircraft engine exhaust emissions (“jet exhaust”), a complex mixture of ultrafine particles and hazardous substances. Evidence from inspections, literature reviews and enforcement action shows that aircraft exhaust contains numerous carcinogenic substances and that exposure can reach extremely high levels in real working conditions. In its final ruling of 3 April 2025 concerning Schiphol airport, the Netherlands Labour Authority found that workers were routinely exposed to exceptionally high concentrations of ultrafine particles—sometimes reaching several million particles per cm³—and in many cases were standing directly in the path of aircraft engine exhaust during routine operations. The Netherlands Labour Authority identified 142 substances and 15 substance groups in aircraft exhaust, including 44 classified as carcinogenic, and concluded that exposure posed a serious and urgent risk to workers’ health, including increased risks of lung cancer, bladder cancer, COPD and cardiovascular disease. In that ruling, extensive and mandatory measures were imposed to reduce exposure. Given the severity of the health consequences, the demonstrated widespread exposure, and the lack of a harmonised Union-level limit value, it is necessary for the Union to accelerate scientific assessment and move towards establishing an occupational exposure limit value for aircraft engine exhaust emissions.

(3) The substances, mixtures and processes referred to in Annex I to Directive 2004/37/EC, and the substances and mixtures released by those processes, vary as to whether they have carcinogenic, mutagenic or reprotoxic effects. It is therefore appropriate to clarify the definitions of ‘carcinogen’, ‘mutagen’ and ‘reprotoxic substance’ provided for in that Directive, to ensure that the relevant substances, mixtures and processes are covered by each of those definitions. It is also appropriate to align the definition of ‘reprotoxic substance’ with the definitions of ‘carcinogen’ and ‘mutagen’.

Recital 9 d (new): (9d) In order to prevent or reduce exposure to carcinogens, mutagens and reprotoxic substances, Directive 2004/37/EC sets out a hierarchy of technical and organisational measures. In this context personal protective equipment (PPE), in particular respiratory equipment, should be used where appropriate, as a last resort. It is necessary to ensure that PPE is adjusted to a particular worker’s body-type and shape and that it is appropriately maintained, so that it can be an effective tool by which to reduce or eliminate exposure. Employers should therefore ensure that PPE is individually adjusted, including through fitting checks, in accordance with Council Directive 89/656/EEC.

(4) For mutagens and most carcinogens, it is not scientifically possible to identify levels below which exposure would not lead to adverse health effects. Although setting limit values for exposure at the place of work in relation to carcinogens and mutagens in Directive 2004/37/EC contributes to a significant reduction of risks arising from such exposure by means of the stepwise and goal-setting approach adopted in that Directive, it nonetheless does not completely eliminate risks to the health and safety of workers arising from exposure at work (residual risks). Therefore, it is essential that the existence of such residual risks be communicated to workers in a clear and transparent manner during the training of workers provided for in that Directive. A list of residual risks associated with the current binding OELs for carcinogens under Directive 2004/37/EC and Directive 2009/148/EC of the European Parliament and of the Council was adopted by consensus by the ACSH in its opinion entitled “Communication of the residual risks associated with the binding OELs of carcinogens” of 10 December 2025.

Recital 11 a (new): (11a) The occupational exposure limit values set by Directive 2004/37/EC are essential for ensuring minimum standards at Union level to protect workers from dangerous substances. They should be kept under regular scrutiny and strictly reviewed at least every five years on the basis of advances in knowledge and technologies, in order to ensure ongoing consistency with Regulation (EC) No 1907/2006 and with social, economic and technological developments and further lowered, where appropriate. The ordinary legislative procedure to set binding limit values under Directive 2004/37/ EC is essential because it is not a matter for technical consideration alone but requires political assessment.

(5) It is possible that certain workers are more exposed or more vulnerable to different types of substances because of their gender. This should continue to be taken into account in occupational health and safety research, scientific studies and in the opinions of the RAC and the ACSH, while taking into account the objective of participation of men and women in the labour market.

Recital 11 b (new): (11b) Firefighters and emergency services personnel are at risk of exposure to a variety of hazards resulting from fires and from non-fire events in the course of their work, including to carcinogens, mutagens and reprotoxic substances. The World Health Organization has classified the occupational exposure of firefighters as carcinogenic. It is therefore important that the employers of firefighters, including volunteer firefighters and emergency services personnel assess, in accordance with Directive 2004/37/EC, and reduce the risk of exposure to carcinogens, mutagens and reprotoxic substances and that they take the necessary measures to protect the health and safety of those workers, in particular with regard to decontamination and prevention in accordance with Directive 2009/148/EC following the removal of asbestos. Important guidance has also been developed on risks arising from asbestos exposure, including sector-specific guidance for firefighters and emergency services personnel. This revision should strengthen the protection of firefighters against polycyclic aromatic hydrocarbons (PAHs). To that end, the Commission, in cooperation with EU-OSHA and the ECHA should develop Union guidance for emergency services on PAHs as well as other combustion-related carcinogenic exposures, covering exposure assessment strategies, decontamination, station hygiene, handling, storage and cleaning of personal protective equipment (PPE), and prevention during clean-ups. Guidance should sp…

(6) Certain substances covered by Directive 2004/37/EC are used in sectors of strategic importance to the Union. While advancing the industrial transition, stimulating the circular economy and maintaining and enhancing the international strategic autonomy in raw materials are all priorities of the Union, it is essential to ensure that workers receive a high and comparable level of protection against health risks related to occupational exposure. Principle 10 of the European Pillar of Social Rights also recognises the right of workers to a high level of protection of their health and safety at work, which includes protection from exposure to carcinogens, mutagens and reprotoxic substances at the place of work. In that regard, the process for setting OEL values takes into account not only scientific and health considerations, but also socioeconomic aspects, which in some cases justify the establishment of transitional periods.

Recital 11 c (new): (11c) Workers are often exposed to a cocktail of hazardous substances at the workplace, which can increase risks and cause adverse health effects. In the case of exposure to a combination of substances acting by the same mode of action or at the same target cell or tissue, it is necessary to adapt the implementation of their possible limit values to take into account the combined effects. This is particularly relevant for firefighters and emergency services personnel. The Commission and Member States should provide guidance on how inspectors and employers are to evaluate compliance and prevention where multiple carcinogens co-occur and encourage the development and use of appropriate methodologies and tools to address combined exposures.

(7) The IARC classified welding fumes as ‘carcinogenic to humans’ (Group 1 of the IARC classification). According to the ECHA Scoping Study report for evaluation of limit values for welding fumes and fumes from other processes that generate fume in a similar way at the workplace (the ‘ECHA Scoping Study report’), welding fumes and fumes from other processes that generate fumes in a similar way are complex and can include carcinogens, mutagens or reprotoxic substances, such as chromium(VI) compounds, nickel compounds, cadmium and its inorganic compounds. The ACSH, having considered the latest available scientific evidence, including the ECHA Scoping Study report as regards the impact on workers' health and safety, recommended including in Annex I to Directive 2004/37/EC only work involving exposure to welding fumes. The complexity and heterogeneity of welding fumes, together with the absence of harmonised classification in Regulation (EC) No 1272/2008, contribute to a lack of clarity regarding the extent of their possible danger to workers, and therefore a lack of appropriate risk management measures at the place of work. Addressing that absence of classification for welding fumes at Union level would ensure more legal clarity with regard to the application of Directive 2004/37/EC. It is therefore appropriate, in line with the opinion of the ACSH, to include in Annex I to Directive 2004/37/EC work involving exposure to ▌ fumes from welding processes, containing substances or mixtures which meet the criteria for classification as a category 1A or 1B carcinogen, mutagen or reproductive toxicant set out in Annex I to Regulation (EC) No 1272/2008. That ACSH opinion also included a recommendation to develop guidance on welding fumes. In addition to the existing guidance, such as the Guidance for National Labour Inspectors on addressing health risks from Welding Fume developed by the Senior Labour Inspectors’ Committee in 2018, further Union guidance, in line with the EU Strategic Framework on Health and Safety at work on the basis of the latest scientific evidence, could assist labour inspectors and enterprises, especially small and medium-sized enterprises (SMEs), including microenterprises, in ensuring compliance with the welding fumes entry in Annex I to Directive 2004/37/EC. Such guidance could serve to promote, inter alia, a common minimum high level of protection across the Member States for all workers exposed to welding fumes.

Recital 11 d (new): (11d) Directive 2004/37/EC sets binding OELs for certain substances for which there is no safe level of exposure for workers’ health. However, such binding OELs do not eliminate residual risks. As many of such carcinogens cannot be eliminated, substituted or have exposure to them minimised, it is essential that such residual risks are communicated to workers clearly and openly during the training of workers foreseen under Directive 2004/37/EC. A list of residual risks associated with the existing binding OELs for carcinogens under Directives 2004/37/EC and 2009/148/EC was adopted by consensus by the ACSH 1a. / 1a ACSH Opinion WPC on Residual Risks-Doc document 016-25 adopted on 10.12.2025. https://osha.europa.eu/en/legislation/directive/directive-200437ec-carcinogens-or-mutagens-work

(8) Cobalt metal and several cobalt compounds meet the criteria for classification as category 1B carcinogens and reproductive toxicants in accordance with Regulation (EC) No 1272/2008, and are therefore carcinogens or reprotoxic substances as defined in Directive 2004/37/EC. Workers are often exposed to a mixture of cobalt compounds, and OEL values should thus be applied to all inorganic cobalt compounds. It is therefore appropriate, on the basis of available information, including scientific and technical data, to establish a limit value for cobalt and inorganic cobalt compounds in Directive 2004/37/EC.

A list of residual risks associated with Binding Occupational Exposure Limit Values of carcinogens under the CMRD (2004/37/EC) and the Asbestos at Work Directive (2009/148/EC) is available at the following link of the European agency EU-OSHA: https://osha.europa.eu/en/legislation/directive/directive-200437ec-carcinogens-or-mutagens-work.

(9) The ACSH concluded, on the basis of an opinion of the RAC, that exposure to cobalt and inorganic cobalt compounds at the place of work can also result in dermal sensitisation and the sensitisation of the respiratory tract. It is therefore appropriate to establish limit values for both the inhalable and respirable fractions of cobalt and inorganic compounds thereof within the scope of Directive 2004/37/EC, and to assign to them a notation for dermal and respiratory sensitisation.

Recital 11 e (new): (11e) There is a need for workers to receive sufficient and appropriate training, on the basis of all available information, when they are exposed or are likely to be exposed to carcinogens, mutagens or reprotoxic substances, including those contained in certain hazardous medicinal products. The training that the employer is required to provide pursuant to Article 11 of Directive 2004/37/EC should be adapted to take account of a new or changed risk, in particular when workers are exposed to new carcinogens, mutagens or reprotoxic substances or to a number of different carcinogens, mutagens or reprotoxic substances, including in hazardous medicinal products, or in the case of changing circumstances related to work, and repeated periodically if necessary.

(10) For cobalt and inorganic cobalt compounds, it is foreseeable that it will be difficult to comply in the short term with a limit value of 0,01 mg/m³ for the inhalable fraction and 0,0025 mg/m³ for the respirable fraction. It is therefore appropriate to introduce a transitional period of six years after the date of entry into force of this Directive, during which the limit values of 0,02 mg/m³ (inhalable fraction) and 0,0042 mg/m³ (respirable fraction) are to apply.

Recital 11 f (new): (11f) Union-wide data from work-related health problems due to exposure to cobalt and its inorganic compounds, polycyclic aromatic hydrocarbons, isoprene and 1,4-dioxane are often absent, unreliable or insufficient. The Commission should develop guidelines and recommendations for data collection by the Member States to improve the reporting and exposures registries.

(11) Cobalt is used in several sectors, such as the batteries sector, which are of strategic importance for reaching the goals set out in the European Green Deal and in Regulation (EU) 2021/1119 of the European Parliament and of the Council. Cobalt is a hazardous metal posing serious health risks to workers, such as respiratory problems, heart, thyroid, liver or kidney damage and potential cancer, and its consumption is projected to rise by approximately 330 % by 2050 as a result of the green transition, making it particularly important to ensure a high level of protection of workers’ health and safety. OELs for cobalt and inorganic cobalt compounds are thus necessary to help prevent long-term effects on the health and wellbeing of workers and to support the attractiveness, competitiveness and long-term sustainability of the cobalt industry in the Union, while avoiding the relocation of cobalt-processing enterprises to third countries with less stringent occupational safety and health regulations.

Recital 12 a (new): (12a) Achieving a high level of protection of workers against risks related to carcinogens, mutagens and reprotoxic substances requires the effective implementation of this Directive. Member States should maintain equal protection for all workers and should facilitate the compliance of SMEs including microenterprises with the obligations stemming from this Directive. SMEs including microenterprises, which represent a large majority of enterprises in the Union, have limited financial, technical and human resources. Member States should therefore monitor and report the effects of the implementation of this Directive on SMEs including microenterprises, in particular any administrative requirements, in order to ensure that they are not disproportionately affected and have the financial and administrative capacity to comply with the obligations laid down in Directive 2004/37/EC and to progress towards the elimination of risks relating to exposure to carcinogens, mutagens and reprotoxic substances at the workplace, thus benefitting all workers. Specific measures, such as financial and technical support, could help SMEs including microenterprises.

(12) Certain sectors in which workers are exposed to substances such as cobalt and polycyclic aromatic hydrocarbons (PAHs) can face difficulties in complying with the OELs. In those sectors where exposure can neither be avoided nor adequately reduced by other means in accordance with Article 5 of Directive 2004/37/EC, respiratory protective equipment should be available and properly used by workers in accordance with the assessment of risks provided for in Article 3(2) of that Directive, in order to ensure that workers are appropriately protected. It is necessary that all Member States implement the rules in accordance with the hierarchy of control measures set out in Article 5 of that Directive, to eliminate or minimise workers’ exposure in a consistent manner, in order to ensure a level playing field across Member States.

Recital 12 b (new): (12b) The ACSH adopted on 29 May 2024 an Opinion1a on priority chemicals for new or revised occupational exposure limit values under the Union legal framework on occupational safety and health, which contains a list of priority substances to be proposed for developing a proposal for a Union limit value under Directive 2004/37/EC. In particular the list includes five substances or group of substances classified as 'Immediate priority substances' (Oximes, Butanone oxime, N-(Hydroxymethyl) acrylamide (NMA), Organotins and Ethylene dibromid). The ACSH strongly recommended that the Commission use that list when selecting chemicals for developing legislative proposals for new, or revised, limit values under Directive 2004/37/EC. / 1a ACSH document 006-24, https://circabc.europa.eu/ui/group/cb9293be-4563-4f19-89cf-4c4588bd6541/library/1c3986a7-b583-4382-a6bc-d712eace2b47/details

(13) In order to prevent or reduce exposure to carcinogens, mutagens and reprotoxic substances, Directive 2004/37/EC sets out a hierarchy of technical and organisational measures. In that context, personal protective equipment (PPE), in particular individual respiratory protective equipment, should be used only as a last resort. It is necessary to ensure that PPE is chosen and used in accordance with Council Directive 89/656/EEC, including the requirement that all PPE fit the wearer correctly after any necessary adjustment, and comply with the relevant Union provisions on design and manufacture with respect to safety and health, in particular Regulation (EU) 2016/425 of the European Parliament and of the Council. In addition, it is necessary to ensure that PPE is kept in good working order and satisfactory hygienic condition by means of the necessary maintenance, repair and replacements.

~~Directive 2004/37/EC~~

(14) Certain PAH mixtures, particularly those containing benzo[a]pyrene, meet the criteria for classification as a category 1A or 1B carcinogen, mutagen or reproductive toxicant in accordance with Regulation (EC) No 1272/2008, and therefore fall within the scope of Directive 2004/37/EC. The RAC has identified the possibility of significant uptake through the skin for those mixtures, and the ACSH has agreed on the importance of introducing an OEL value for all PAH mixtures falling within the scope of Directive 2004/37/EC, measured as benzo[a]pyrene, and to maintain a skin notation already contained in Annex III to that Directive.

Article 1 – paragraph 1 – point -1 (new), Article 2 – paragraph 1 – point a – point ii: (-1) in Article 2, point (a)(ii) is replaced by the following: / ‘(ii) a substance, mixture or process referred to in points 1 to 8 of Annex I to this Directive as well as a substance or mixture released by a process referred to in those points;’

(15) For PAH mixtures, it is foreseeable that it will be difficult for some sectors to comply in the short term with a limit value of 0,00007 mg/m³ (measured as benzo[a]pyrene). It is therefore appropriate to introduce a transitional period of seven years after the date of entry into force of this Directive, during which the limit value of 0,00014 mg/m³ (measured as benzo[a]pyrene) is to apply. That transitional period should be limited to the following sectors: (a) steel and iron foundries, which include ferroalloy manufacturers; (b) aluminium manufacturers; (c) carbon and graphite ▌ manufacturers; (d) coking plants; (e) coal tar distillation; (f) refractory products manufacturers; (g) train track welding; (h) other non-ferrous metallurgical processes; and (i) metal casting.

~~(32004L0037 (Document 02004L0037-20240408))~~

(16) Available scientific and technical data, including the opinions of the RAC and the ACSH, indicate that isoprene meets the criteria for classification as a category 1B carcinogen in accordance with Regulation (EC) No 1272/2008, and is therefore a carcinogen as defined in Directive 2004/37/EC. It is therefore appropriate, consistently with the outcome of the tripartite process, to establish a long-term OEL value of 8,5 mg/m3 (3 ppm), with a view to preventing potential health risks to workers and to ensuring a level-playing field across Member States.

~~Directive 2004/37/EC~~

(17) 1,4-dioxane meets the criteria for classification as a category 1B carcinogen in accordance with Regulation (EC) No 1272/2008, and is therefore a carcinogen as defined in Directive 2004/37/EC. It is therefore appropriate, on the basis of the available information, including scientific and technical data, such as the opinions of the RAC and the ACSH, to establish a long-term and a short-term OEL value of 7,3 mg/m³ (2 ppm) and 73 mg/m³ (20 ppm), respectively, supplemented by a skin notation, as well as a biological limit value of 45 mg HEAA in urine/g creatinine, measured at the end of exposure or shift in accordance with national law or practice.

Article 1 – paragraph 1 – point -1 a (new), Article 2 – paragraph 1 – point a – point ii a (new): (-1a) in Article 2, a new point (a)(iia) is added: / ‘(iia) a substance, mixture or process referred to in point 9 of Annex I to this Directive as well as a substance or mixture released by a process referred to in that point, where it has carcinogenic effects;’

(18) Directive (EU) 2022/431 of the European Parliament and the Council extended the scope of Directive 2004/37/EC to include reprotoxic substances, including mercury and divalent inorganic mercury compounds, which were added to Annex III to Directive 2004/37/EC. Since not all divalent inorganic mercury compounds can be classified as reprotoxic substances, it is necessary to clarify that the limit value applies only to mercury and divalent inorganic mercury compounds that fall within the scope of Directive 2004/37/EC.

~~Directive 2004/37/EC~~

(19) Hazardous medicinal products, in so far as they contain carcinogenic, mutagenic or reprotoxic substances, fall within the scope of Directive 2004/37/EC, as acknowledged in the working definitions and examples laid down in the Commission’s Guidance of 28 April 2023 for the safe management of hazardous medicinal products at work. To facilitate identifying those substances, the Commission published on 20 February 2025 a communication entitled ‘Indicative list of hazardous medicinal products according to Article 18a of 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, mutagens or reprotoxic substances at work’, thereby enabling the consistent application of Directive 2004/37/EC to safeguard the health and safety of exposed workers.

Article 1 – paragraph 1 – point -1 b (new), Article 2 – paragraph 1 – point b – point ii: (-1b) in Article 2, point (b)(ii) is replaced by the following: / ‘(ii) a substance, mixture or process referred to in points 1 to 8 of Annex I to this Directive as well as a substance or mixture released by a process referred to in those points;’

(20) The Commission has carried out a two-stage consultation of social partners in accordance with Article 154 TFEU. It has also consulted the ACSH. The ACSH has adopted opinions for all substances subject to this Directive, and has recommended one or several binding limit values for each of them, and notations and transitional values for some of them, where appropriate. Transitional values allow employers to make the necessary investments in additional risk management measures and develop technical means by which to ensure compliance. In that regard, existing Union programmes, such as Horizon Europe, could help to develop innovative solutions to protect workers’ health.

~~(32004L0037 (Document 02004L0037-20240408))~~

(21) It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. When establishing or revising limit values, the Commission should consult the RAC and the ACSH to ensure that those values are evidence-based, proportionate and measurable.

~~Directive 2004/37/EC~~

(22) It is essential that the ordinary legislative procedure be used in order to set binding limit values under Directive 2004/37/EC because amending that Directive is not a matter for technical consideration alone, but also requires a political assessment.

Article 1 – paragraph 1 – point -1 c (new), Article 2 – paragraph 1 – point b – point ii a (new): (-1c) in Article 2, a new point (b)(iia) is added: / (iia) a substance, mixture or process referred to in point 9 of Annex I to this Directive as well as a substance or mixture released by a process referred to in that point, where it has mutagenic effects;

(23) Certain workers, in particular firefighters and other emergency services personnel are at risk of exposure to a variety of hazards resulting from fires and from non-fire events in the course of their work, including to carcinogens, mutagens and reprotoxic substances. It is therefore important that the employers of firefighters and other emergency services personnel assess and reduce the risk of exposure to carcinogens, mutagens and reprotoxic substances in accordance with Directive 2004/37/EC, with a view to strengthening the protection of firefighters and other emergency services personnel against, inter alia, PAHs thereby reducing the risk of occupational diseases. Guidance has already been developed on risks arising from exposure to asbestos, including sector-specific guidance for firefighters and other emergency services personnel. In view of the specific and high-level risks inherent to emergency services, it is important that the European Agency for Safety and Health at Work (EU-OSHA), in cooperation with relevant social partners and national authorities, consider developing a specific Online interactive Risk Assessment (OiRA) tool tailored to the needs of those services.

~~Directive 2004/37/EC~~

(24) Workers are often exposed to a cocktail of hazardous substances at the place of work, which can increase risks and cause adverse health effects. In the case of exposure to a combination of substances acting by the same mode of action or acting upon the same target organs, tissues or cells, it can be necessary to adapt the implementation of the OEL values established pursuant to Directive 2004/37/EC, to take into account the combined effects of those substances. This is relevant, inter alia, for firefighters and other emergency services personnel. When preparing Union guidelines on the effects of exposure to a combination of substances, the Commission should take into account the relevant specificities of those services. Such guidelines should be published on the EU-OSHA website and disseminated in all Member States by the relevant competent authorities.

Article 1 – paragraph 1 – point -1 d (new), Article 2 – paragraph 1 – point ba: (-1d) in Article 2, point (ba) is replaced by the following: / (ba) “reprotoxic substance” means: / (i) a substance or mixture which meets the criteria for classification as a category 1A or 1B reproductive toxicant set out in Annex I to Regulation (EC) No 1272/2008; / (ii) a substance, mixture or process referred to in point 9 of Annex I to this Directive as well as a substance or mixture released by a process referred to in that point, where it has reprotoxic effects;’

(25) There is a need for workers to receive sufficient and appropriate training, on the basis of all available information, when they are exposed to, or are likely to be exposed to, carcinogens, mutagens or reprotoxic substances, including those contained in certain hazardous medicinal products. The training that the employer is required to provide pursuant to Directive 2004/37/EC should be adapted to take account of a new or changed risk, in particular when workers are exposed to new carcinogens, mutagens or reprotoxic substances or to a number of different carcinogens, mutagens or reprotoxic substances, including in hazardous medicinal products, or in the case of changing circumstances related to work. That training should be repeated periodically if necessary.

~~(32004L0037 (Document 02004L0037-20240408))~~

(26) Union-wide data from work-related health problems due to exposure to cobalt and inorganic cobalt compounds, PAHs, isoprene and 1,4-dioxane are often unavailable, unreliable or insufficient. It could therefore be appropriate for the Commission to consider developing recommendations for data collection by the Member States to improve the reporting and exposures registries.

~~Directive 2004/37/EC~~

(27) Achieving a high level of protection of workers against risks related to carcinogens, mutagens and reprotoxic substances requires that Member States maintain equal protection for all workers and facilitate the compliance of SMEs, including microenterprises, with the obligations stemming from Directive 2004/37/EC. SMEs, including microenterprises, which represent a large majority of enterprises in the Union, have limited financial, technical and human resources. It is important that SMEs, including microenterprises, have the capacity to comply with that Directive, are not disproportionately affected, in particular by administrative requirements, and are able to progress towards the elimination of risks relating to exposure to carcinogens, mutagens and reprotoxic substances at the place of work, thus benefitting all workers.

Article 1 – paragraph 1 – point -1 e (new), Article 2 – paragraph 1 – point e a (new): (-1e) in Article 2, the following point is added. / ‘(ea) “hazardous medicinal products” means medicinal products that contain one or more substances that meet the criteria for classification as a category 1A or 1B carcinogen, mutagen or reprotoxic as set out in Annex I to Regulation (EC) No 1272/2008.’

(28) On 29 May 2024, the ACSH adopted an opinion on priority chemicals for new or revised occupational exposure limit values under EU OSH legislation, which identifies a list of priority substances to be used when developing a proposal for a Union limit value under Directive 2004/37/EC. In particular, the list includes five substances or group of substances classified as ‘Immediate priority substances’ (Oximes, Butanone oxime, N-(Hydroxymethyl) acrylamide (NMA), Organotins and Ethylene dibromide). The ACSH strongly recommended that the Commission use that list when selecting which chemicals to include in its legislative proposals amending Directive 2004/37/EC for the purpose of including new or revised limit values.

~~Directive 2004/37/EC~~

(29) Since the objective of this Directive, namely to protect workers from exposure to carcinogens, mutagens and reprotoxic substances at work, cannot be sufficiently achieved by the Member States acting alone, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary to achieve that objective. ▌

Article 1 – paragraph 1 – point -1 f (new), Article 2 – paragraph 1 – point e b (new): (-1f) in Article 2, the following point is added: / '(eb) “medicinal products” means medicinal products as defined in Article 1 paragraph 2 of Directive 2001/83/EC.’

(30) Directive 2004/37/EC should therefore be amended accordingly,

~~Directive 2004/37/EC~~

HAVE ADOPTED THIS DIRECTIVE:

Article 1 – paragraph 1 – point -1 g (new), Article 5 – paragraph 5 – subparagraph 1 a (new): (-1g) in Article 5(5), the following subparagraph is added: / ‘Individual protection measures as referred to in point (g) shall include personal protective equipment (PPE), in particular respiratory protective devices, where, despite putting in place the technical and organisational measures for prevention or reduce exposure in accordance with this Article, residual exposure cannot be reduced to levels below the limit values set out in Annex III. In such cases, compliance with the limit values shall be determined taking into account the protection afforded by PPE. PPE shall be correctly maintained, selected and adjusted to fit the wearer, including by means of individual fitting, in accordance with Article 4 of Council Directive 89/656/EEC.’

Article 1

Directive 2004/37/EC is amended as follows:

Article 1 – paragraph 1 – point -1 h (new), Article 10 – paragraph 2 a (new): (-1h) in Article 10, the following paragraph is added: / ‘2a. When wearing personal protective equipment, workers shall be entitled to regular breaks of an appropriate duration in an area where there is no risk of contamination by carcinogens, mutagens or reprotoxic substances.’

(1) Article 2 is amended as follows:

~~Directive 2004/37/EC~~

(a) in point (a), point (ii) is replaced by the following:

Article 1 – paragraph 1 – point -1 i (new), Article 11 – paragraph 1 – subparagraph 1 – point a: (-1i) in Article 11(1), subparagraph 1, point (a) is replaced by the following: / ‘ a) potential risks to health, including the additional risks due to tobacco consumption and the existence of residual risks linked to binding limit values listed in Annex III, with reference to information published by EU OSHA, where available;’

‘(ii) a substance, mixture or process referred to in Annex I to this Directive, or a substance or mixture released by a process referred to in that Annex, which has carcinogenic effects;’;

~~Directive 2004/37/EC~~

(b) in point (b), point (ii) is replaced by the following:

Article 1 – paragraph 1 – point -1 j (new), Article 18a – paragraph 11 a (new): (-1j) in Article 18a, the following paragraph is added: / ‘11a. No later than ... [12 months after the entry into force of this directive] and taking into consideration the recent classification by the World Health Organization of occupational exposure in certain occupations as carcinogenic, the Commission shall begin a consultation with the ACSH on the need to update Commission Recommendation (EU) 2022/2337, with a view to encouraging Member States to introduce provisions ensuring more adequate compensation for diseases suspected of being linked to occupational exposure in certain professions.’

‘(ii) a substance, mixture or process referred to in Annex I to this Directive, or a substance or mixture released by a process referred to in that Annex, which has mutagenic effects;’;

~~Directive 2004/37/EC~~

Article 1 – paragraph 1 – point -1 k (new), Article 18a – paragraph 11 b (new): (-1k) in Article 18a, the following paragraph is added: / ‘11b. The Commission’s proposal shall include ‘work involving exposure to aircraft engine emissions’ in Annex I of Directive 2004/37/EC.’

‘(ba) “reprotoxic substance” means:

~~Directive 2004/37/EC~~

(i) a substance or mixture which meets the criteria for classification as a category 1A or 1B reproductive toxicant set out in Annex I to Regulation (EC) No 1272/2008;

Article 1 – paragraph 1 – point -1 l (new), Article 18a – paragraph11 c (new): (-1l) in Article 18a, the following paragraph is added: / ‘11c. No later than ... [3 years after the entry into force of this amending directive], the Commission shall, taking into account the latest developments in scientific knowledge, the opinion of RAC and after appropriate consultation with relevant stakeholders, propose, where appropriate, limit value(s) for welding fumes as defined in Annex I to Directive 2004/37/EC.’

(ii) a substance, mixture or process referred to in Annex I to this Directive, or a substance or mixture released by a process referred to in that Annex, which has reprotoxic effects;’;

~~Directive 2004/37/EC~~

(2) in Article 5(5), the following subparagraph is added:

Article 1 – paragraph 1 – point -1 m (new), Article 18a – paragraph 11d (new): (-1m) in Article 18a, the following paragraph is added: / '11d. Where the Commission submits a legislative proposal amending the occupational exposure limit values set out in this Directive, it shall take into account any opinions of the Committee for Risk Assessment of the European Chemicals Agency established by Regulation (EC) No 1907/2006 and the opinions of the ACSH, as appropriate. In the absence of any such opinion, the Commission shall set out, in its proposal, the reasons underpinning it, on the basis of scientific evidence.'

‘Individual protection measures as referred to in point (g) of the first subparagraph of this paragraph shall include personal protective equipment, in particular respiratory protective devices, where, despite putting in place the technical and organisational measures for the prevention or reduction of exposure in accordance with this Article, exposure cannot be avoided or adequately reduced by other means. In such cases, personal protective equipment shall be used as a last resort to ensure that workers are adequately protected and, in any case, to avoid exposure exceeding established limit values. Personal protective equipment shall be correctly chosen, individually adjusted to fit the wearer, and maintained, in accordance with Articles 4 and 5 of Council Directive 89/656/EEC*.

Article 2 – paragraph 1: Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by no later than … [two years after its entry into force]. They shall immediately inform the Commission thereof.

_____________

~~Directive 2004/37/EC~~

* Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (third individual directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 393, 30.12.1989, p. 18,ELI: http://data.europa.eu/eli/dir/1989/656/oj ).’;

Annex – paragraph 1 – point -1 (new), Annex I – title: (-1) in Annex I, the title is replaced by the following: / ‘List of substances, mixtures and processes (Article 2, point (a)(ii) and (iii), point (b)(ii) and point (iii) and (ba)(ii))’

(3) in Article 10, the following paragraph is added:

~~(32004L0037 (Document 02004L0037-20240408))~~

‘3. When wearing personal protective equipment, workers shall be entitled to regular breaks in an area where there is no risk of contamination by carcinogens, mutagens or reprotoxic substances. The duration and frequency of the breaks shall be determined by taking into account the assessment of the risks to safety and health at work.’;

~~Directive 2004/37/EC~~

(4) in Article 18a, the following paragraph is added:

Annex II – paragraph 1 – point 1, Annex I – point 9: 9. Work involving exposure to welding fumes and fumes from other processes that generate fumes in a similar way, containing substances or mixtures that meet the criteria for classification as a category 1A or 1B carcinogen, mutagen or reprotoxic set out in Annex I to Regulation (EC) No 1272/20081 ;

‘12. The Commission shall take into account any new developments in scientific knowledge, including the opinions of the Committee for Risk Assessment of the European Chemicals Agency, and shall assess, after appropriate consultation of relevant stakeholders, where appropriate, whether to set additional limit values for substances contained in welding fumes as referred to in Annex I, point (9), to this Directive.’;

~~Directive 2004/37/EC~~

(5) Annexes I, III and IIIa to Directive 2004/37/EC are amended in accordance with the Annex to this Directive.

Annex – paragraph 1 – point 1, Annex I – point 9 a (new): 9a. Work involving exposure to hazardous medicinal products containing substances that meet the criteria for classification as a category 1A or 1B carcinogen, mutagen or reprotoxic as set out in Annex I to Regulation (EC) No 1272/2008.

Article 2

~~Directive 2004/37/EC~~

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by … [ ▌ two years after the date of entry into force of this Directive]. They shall immediately inform the Commission thereof.

~~1 Exposure shall not exceed the limit value of a carcinogen, mutagen or a reprotoxic substance as set out in Annex III when those substances are released during the welding process.~~

When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such ▌ reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

~~Directive 2004/37/EC~~

2. Member States shall communicate to the Commission the text of the main measures of national law which they adopt in the field covered by this Directive.

~~Directive 2004/37/EC~~

Article 3

~~Directive 2004/37/EC~~

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

~~Annex II – paragraph 1 – point 3, Annex IIIa: The binding biological limit value is 45 mg HEAA*in urine/g creatinine, measured at the end of exposure or shift.’~~

Article 4

~~EXPLANATORY STATEMENT~~

This Directive is addressed to the Member States.

Occupational exposure to hazardous substances remains one of the most serious risks to workers’ health in the European Union. Each year about 120,000 work-related cancer cases occur as a result of exposure to carcinogens at work in the EU, leading to approximately 80,000 fatalities annually. Since its first adoption in 2004, the carcinogens and mutagens directive has been reviewed five times and now addresses 28 cancer-causing substances. This revision supports Europe’s Beating Cancer Plan and the EU Strategic Framework on Health and Safety at Work 2021–2027, which promotes a “vision zero” approach to work-related deaths.

Done at …,

The sixth revision of Directive 2004/37/EC extends protection for millions of workers across sectors such as manufacturing, construction, healthcare, emergency services, waste management, and the circular economy.

For the European Parliament For the Council

Directive 2004/37/EC has a strong tradition of a multi-stage, evidence-based and consultative legislative procedure. It is very important that revised limit values are based on a scientific evaluation and on the opinion of the Advisory Committee on Safety and Health at Work (ACSH). The ACSH is composed of representatives of the Member States and the social partners. The ACSH reviews the scientific and socio-economic evidence.

The President The President

Our position is based on the ACSH opinion. This includes the introduction of binding occupational exposure limit (OEL) values for cobalt and inorganic cobalt compounds, polycyclic aromatic hydrocarbons (PAHs), isoprene and 1,4-dioxane, where previously national limit values varied widely or were lacking. Moreover, we should include welding fumes, when they contain CMR substances such as chromium or nickel, among processes covered by the directive. This would mean that employers must apply protective measures when welding.

ANNEX

Substances such as cobalt are used in several sectors of strategic importance to reach the goals set out in the European Green Deal and the EU Climate Law. They are critical for sectors central to the industrial transition, including batteries and advanced manufacturing. The enhancement of international strategic autonomy in raw materials is one of the priorities of the European Union. Moreover, there is clearly a need to avoid relocating cobalt-processing activities to non-EU countries with weaker occupational safety standards.

Annexes I, III and IIIa to Directive 2004/37/EC are amended as follows:

Given the rapidly evolving geopolitical situation and its potential effects on supply chains and strategic dependencies, the Commission should regularly reassess substances such as cobalt. Building on these assessments, and in consultation with social partners and Member States, the Commission should consider targeted and limited exemptions to existing or new OELs. Such exemptions must be strictly limited to activities where these substances remain essential for the Union’s strategic interests, and workers’ protection must always remain the highest priority.

(1) in Annex I, the title is replaced by the following:

Firefighters and other emergency personnel are particularly exposed to complex mixtures of carcinogenic, mutagenic and reprotoxic substances. The WHO now classifies firefighters’ occupational exposure as carcinogenic. Therefore, we need specific risk assessments, adequate protective measures, and targeted medical surveillance for these high-risk workers.

‘List of substances, mixtures and processes (Article 2, points (a)(ii), (b)(ii) and (ba)(ii))’;

Reliable EU-wide data on exposures to substances such as cobalt, polycyclic aromatic hydrocarbons, isoprene and 1,4-dioxane remain limited. The Commission should develop guidelines and recommendations to improve national data collection and exposure registries. Enhanced EU guidance should also support labour inspectors and enterprises, particularly SMEs and microenterprises, in applying the directive effectively. This includes guidance on welding fumes and similar exposure processes, building on existing tools such as the SLIC guidance from 2018, ensuring that monitoring is evidence-based and enforcement consistent.

(2) in Annex I, the following point is added:

A strong social dialogue is essential for effective implementation. Social partners are indispensable in identifying risks, designing practical prevention measures and ensuring realistic application across sectors. Obligations must remain achievable for SMEs and microenterprises, which often operate with limited financial and technical capacity. Member States should assess administrative impacts and provide targeted support without compromising equal protection for all workers. I have introduced a clear right for workers to take proportionate and regular breaks when using protective equipment, reflecting both safety and well-being considerations.

‘9. Work involving exposure to fumes from welding processes containing substances or mixtures which meet the criteria for classification as a category 1A or 1B carcinogen, mutagen or reproductive toxicant set out in Annex I to Regulation (EC) No 1272/2008*.

Gender differences in exposure patterns, physiological responses and health outcomes remain insufficiently integrated into occupational safety research. Therefore, we need to systematically incorporate a gender perspective in future assessments.

_____________

Training requirements are crucial to ensure that workers receive clear, up-to-date information whenever new risks arise, including handling multiple hazardous substances or hazardous medicinal products. This approach ensures training is directly relevant to the tasks performed and the risks encountered.

* Exposure shall not exceed the limit value of a carcinogen, mutagen or a reprotoxic substance as set out in Annex III to this Directive when those substances are released during the welding process.’;

This revision represents a decisive step in preventing occupational cancers and other long-term health effects across the European Union. It strengthens scientific integrity, legal certainty and protection for workers in high-risk sectors while supporting Europe’s industrial resilience and strategic autonomy. It ensures that SMEs are supported in applying the rules while maintaining equal protection standards for all workers. Above all, this revision reaffirms the fundamental principle that every worker in the European Union has the right to a safe, healthy and sustainable working environment.

(3) in Annex III, point A is amended as follows:

(a) in the table, the row related to ‘Polycyclic aromatic hydrocarbons mixtures, particularly those containing benzo[a]pyrene, which are carcinogens within the meaning of this Directive’, is replaced by the following:

‘

(17) Measured as benzo[a]pyrene.’;

’;

(b) in the table, the row related to ‘Mercury and divalent inorganic mercury compounds including mercuric oxide and mercuric chloride (measured as mercury)’ is replaced by the following:

‘

’;

‘

(18) Inhalable fraction, measured as cobalt.

(19) Respirable fraction, measured as cobalt.’;

(4) Annex IIIa is replaced by the following:

‘ANNEX IIIa

BIOLOGICAL LIMIT VALUES AND HEALTH SURVEILLANCE MEASURES

(Article 16(4))

1. Lead and its inorganic compounds

1.1. Biological monitoring must include measuring the blood lead level (PbB) using absorption spectrometry or a method giving equivalent results.

1.1.1. Until 31 December 2028, the binding biological limit value is:

30 μg Pb/100 ml blood

For workers whose blood lead level exceeds the biological limit value of 30 μg Pb/100 ml blood due to exposure which has occurred before 9 April 2026, but is below 70 μg Pb/100 ml blood, medical surveillance is carried out on a regular basis. If a declining trend towards the limit value of 30 μg Pb/100 ml blood is established in those workers, they may be allowed to continue with work involving exposure to lead.

1.1.2. From 1 January 2029, the binding biological limit value is:

15 μg Pb/100 ml blood*

For workers whose blood lead level exceeds the biological limit value of 15 μg Pb/100 ml blood due to exposure which has occurred before 9 April 2026, but is below 30 μg Pb/100 ml blood, medical surveillance is carried out on a regular basis. If a declining trend towards the limit value of 15 μg Pb/100 ml blood is established in those workers, they may be allowed to continue with work involving exposure to lead.

1.2. Medical surveillance is carried out if exposure to a concentration of lead in air is greater than 0,015 mg/m3, calculated as a time-weighted average over 40 hours per week, or a blood lead level greater than 9 μg Pb/100 ml blood is measured in individual workers. Medical surveillance is also carried out with regard to female workers of childbearing age whose blood lead level exceeds 4,5 μg Pb/100 ml blood or the national reference value of the general population not occupationally exposed to lead, if such a value exists.

2. 1,4-dioxane

The binding biological limit value is 45 mg HEAA** in urine/g creatinine, measured at the end of exposure or shift, in accordance with national law or practice.

________________

* It is recommended that the blood lead level in women of childbearing age does not exceed the reference values of the general population not occupationally exposed to lead in the respective Member State. When national reference levels are not available, it is recommended that blood lead levels in women of childbearing age do not exceed the Biological Guidance Value of 4,5 µg/100 ml.

** (2-Hydroxyethoxy)acetic acid.’