amendment list, 30 January 2026
Amending Directive 2004/37/EC as regards the addition of substances and setting limit values in its Annexes I, III and IIIa
Document EMPL-AM-782282 · (COM(2025)0418 – C100180/2025 – (2025)0418(COD))
Committee on Employment and Social Affairs
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Text 627 paragraphs
Amendment 27
Nora Mebarek, Estelle Ceulemans, Marc Angel, Johan Danielsson
Proposal for a directive
Recital 1
| Text proposed by the Commission | Amendment |
|---|---|
| (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. That information should, if possible, 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 . | (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. That information must 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 . |
| 3 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 (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (codified version), (OJ L 158, 30.4.2004, p. 50). | 3 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 (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (codified version), (OJ L 158, 30.4.2004, p. 50). |
| 4 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj). | 4 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj). |
| 5 Council Decision of 22 July 2003 setting up an Advisory Committee on Safety and Health at Work (OJ C 218, 13.9.2003, p. 1). | 5 Council Decision of 22 July 2003 setting up an Advisory Committee on Safety and Health at Work (OJ C 218, 13.9.2003, p. 1). |
Or. en
Amendment 28
Grégory Allione, Valérie Devaux, Jana Toom, Hristo Petrov, Martin Hojsík
Proposal for a directive
Recital 1
| Text proposed by the Commission | Amendment |
|---|---|
| (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. That information should, if possible, 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 . | (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. That information should, if possible, 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. If it is not possible to include those opinions , the proposal to amend that Directive should set out the reasons clearly. |
| 3 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 (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (codified version), (OJ L 158, 30.4.2004, p. 50). | 3 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 (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (codified version), (OJ L 158, 30.4.2004, p. 50). |
| 4 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj). | 4 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj). |
| 5 Council Decision of 22 July 2003 setting up an Advisory Committee on Safety and Health at Work (OJ C 218, 13.9.2003, p. 1). | 5 Council Decision of 22 July 2003 setting up an Advisory Committee on Safety and Health at Work (OJ C 218, 13.9.2003, p. 1). |
Or. en
Read the rest (615 paragraphs)
Amendment 29
Grégory Allione, Valérie Devaux, Jana Toom, Hristo Petrov
Proposal for a directive
Recital 1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (1 a) 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 undue administrative tasks, in order to ensure that they are not disproportionately affected and have the financial and administrative capacity to comply with the obligations stemming from this Directive. Against that background, specific measures, such as financial and technical support, could help SMEs including microenterprises. |
Or. en
Amendment 30
Grégory Allione, Valérie Devaux, Jana Toom, Hristo Petrov, Martin Hojsík
Proposal for a directive
Recital 2
| Text proposed by the Commission | Amendment |
|---|---|
| (2) Directive 2004/37/EC covers substances or 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 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 that Annex I to demonstrate that these substances, mixtures and processes fall under 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 that substance. | (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 under 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 accelerate 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. |
| 6 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). | 6 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). |
Or. en
Amendment 31
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Recital 2
| Text proposed by the Commission | Amendment |
|---|---|
| (2) Directive 2004/37/EC covers substances or 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 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 that Annex I to demonstrate that these substances, mixtures and processes fall under 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 that substance. | (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 under 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. |
| 6 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). | 6 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). |
Or. en
Amendment 32
Per Clausen
Proposal for a directive
Recital 2 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (2 a) 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 does not completely eliminate risks to the health and safety of workers arising from exposure at work (residual risk), it nonetheless contributes to a significant reduction of risks arising from such exposure by means of the stepwise and goal-setting approach adopted in that Directive. In order to ensure full transparency about the remaining levels of risk and to prevent the misunderstanding that occupational exposure limit values are synonymous with safety or absence of harm, a list of residual risks associated with the binding occupational exposure limit values of carcinogens provided for in that Directive and in Directive 2009/148/EC of the European Parliament and of the Council1a is available on the EU-OSHA agency website 1b. | |
| 1a Directive 2009/148/EC of the European Parliament and of the Council of 30 November 2009 on the protection of workers from the risks related to exposure to asbestos at work (OJ L 330, 16.12.2009, p. 28; ELI: http://data.europa.eu/eli/dir/2009/148/oj). | |
| 1b https://osha.europa.eu/en/legislation/directive/directive-200437ec-carcinogens-or-mutagens-work |
Or. en
Justification
The first part until "adopted in that Directive" is from the Council General Approach, the second part offers a concrete way to enable better transparency for the workers affected.
Amendment 33
Grégory Allione, Valérie Devaux, Jana Toom, Hristo Petrov, Martin Hojsík
Proposal for a directive
Recital 2 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (2 a) Workers may be more exposed and more vulnerable to different types of substances depending on their gender. Therefore, it is essential that the gender dimension is considered in scientific studies and in the opinions of the RAC, ECHA, and ACSH. The representation of men and women varies from one occupation to another. While men are more present in occupations, such as firefighters, with high exposure to certain hazardous substances, women are overrepresented among nurses, midwives, and in the cleaning sector, which areoccupations potentially more exposed to certain hazardous substances or biological agents. It is therefore important that gender-related vulnerability is taken into account when setting occupational exposure limits, while ensuring the full participation of women and men in the labour market. |
Or. en
Amendment 34
Per Clausen
Proposal for a directive
Recital 2 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (2 b) A large number of substances that fall under Directive 2004/37/EC still have no Union-level occupational exposure limit values, and with the current pace of scientific assessment and limit-value setting, the objectives of the EU Strategic Framework on Health and Safety at Work 2021–2027 cannot be met. The La Hulpe Declaration from 16 April 2024 stated that it is important to speed up the setting of minimum standards regarding hazardous substances and to foster the evolution towards substituting them, with particular attention to the prevention of occupational cancers. The ACSH in its Opinion 6-21 of 26 May 2020 expressed concern about the service-level agreement between ECHA and DG EMPL in the Commission, considering that ECHA can be mandated to prepare maximum five scientific opinions and/or scoping studies for occupational exposure limits (OELs) each year. Furthermore, the ACSH urged the Commission to urgently find a solution that would allow for an increase in the capacity of scientific opinion preparations for priority chemicals. Furthermore, in a joint letter of 5 March 2024, the ministers of Cyprus, Czechia, Denmark, Finland, France, Germany, Italy, Lithuania, Luxembourg, the Netherlands, Portugal, Slovenia, Spain and Sweden stressed that the process of preparing scientific opinions and proposing new occupational exposure limit values must be accelerated, including by increasing the scientific and administrative capacity of all Union bodies involved, in particular the ECHA. They also called for those priorities to have a central place in the next EU Strategic Framework on Health and Safety at Work and for work to begin already during the current strategic cycle. It is therefore necessary to reinforce efforts at Union level to speed up the identification, assessment and updating of occupational exposure limit values in order to ensure a high level of protection of workers and to promote productivity, employment attractiveness and a sustainable Union economy. As a consequence, the ECHA and DG EMPL in the Commission should be allocated broader resources in order to increase the number of substances tackled in future amendments to Directive 2004/37/EC. |
Or. en
Justification
This flags the issue of the slow setting of exposure limit. The first revisions of the CMRD covered 11-13 substances per revision, the latest ones only 3-5. This amendments suggests to return to the previous ambitious pace.
Amendment 35
Grégory Allione, Valérie Devaux, Jana Toom, Hristo Petrov
Proposal for a directive
Recital 2 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (2 b) Certain substances covered by Directive 2004/37/EC are used in sectors of strategic importance to the Union. While strengthening the Union's strategic autonomy, particularly in critical raw materials, is a key objective, 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 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. |
Or. en
Amendment 36
Per Clausen
Proposal for a directive
Recital 3
| Text proposed by the Commission | Amendment |
|---|---|
| (3) The IARC classified welding fumes as ‘carcinogenic to humans’ (Group 1 of the IARC classification). According to the ECHA scoping study7 , welding fumes 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 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 fumes from welding processes 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. | (3) The IARC classified welding fumes as ‘carcinogenic to humans’ (Group 1 of the IARC classification). According to the ECHA scoping study7, welding fumes from welding and from 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 fumes from welding and from 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 dust limit under Council Directive 98/24/EC8a. In its opinion of 22 September 2023 on welding fumes, the ACSH also strongly recommended the development of 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 8b developed by the Senior Labour Inspectorate Committee in 2018, further guidance, on the basis of the latest scientific evidence, could be crucial in assisting labour inspectors and enterprises, especially SMEs including microenterprises, in ensuring compliance with the relevant 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 for all workers exposed to welding fumes across the Member States. It is also appropriate for the Commission to prioritise the assessment of the usefulness of further guidance in the context of evaluating the current EU Strategic Framework on Health and Safety at Work and developing the possible post-2027 EU Strategic Framework. |
| 7 ECHA (2022), 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, available at: report_welding_fumes_en.pdf (europa.eu) | 7 ECHA (2022), 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, available at: report_welding_fumes_en.pdf (europa.eu) |
| 8 ACSH (2023), Opinion on introducing work involving exposure to fumes from welding processes containing substances that meet the criteria for CMR category 1A/1B set out in Annex I to the CLP Regulation, Doc. 006/23, available at: ACSH Adopted opinion Welding fumes 22.09.23-EN.pdf (europa.eu) | 8 ACSH (2023), Opinion on introducing work involving exposure to fumes from welding processes containing substances that meet the criteria for CMR category 1A/1B set out in Annex I to the CLP Regulation, Doc. 006/23, available at: ACSH Adopted opinion Welding fumes 22.09.23-EN.pdf (europa.eu) |
| 8a Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) - (OJ L 131, 5.5.1998, p. 11). | |
| 8b Senior Labour Inspectors Committee (2018), Guidance for National Labour Inspectors on addressing health risks from Welding Fume. Available at: https://circabc.europa.eu/ui/group/fea534f4-2590-4490-bca6-504782b47c79/library/2997b89a-1fbd-4f35-9874-9a9b5ea1a403?p=1&n=-1&sort=name_ASC |
Or. en
Amendment 37
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Recital 3
| Text proposed by the Commission | Amendment |
|---|---|
| (3) The IARC classified welding fumes as ‘carcinogenic to humans’ (Group 1 of the IARC classification). According to the ECHA scoping study7 , welding fumes 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 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 fumes from welding processes 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. | (3) The IARC classified welding fumes as ‘carcinogenic to humans’ (Group 1 of the IARC classification). According to the ECHA scoping study7 , fumes from welding and fumes from other processes that generate fume in a similar way at the workplace 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 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 fumes from welding and from processes that generate fumes in a similar way containing substances or mixtures 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. In its opinion on welding fumes the ACSH also recommended further measures to reduce the health effects of exposure to particles from welding fumes and other sources, including the establishment of a general dust limit under Directive 98/24/EC. The ACSH also strongly recommended the development of further guidance on welding fumes in addition to the existing ones. Further guidance, on the basis of the latest scientific evidence, could serve to better assist labour inspectors and enterprises, particularly small and medium enterprises and microenterprises, in ensuring compliance with the relevant 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 for all workers exposed to welding fumes across the Member States. |
| 7 ECHA (2022), 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, available at: report_welding_fumes_en.pdf (europa.eu) | 7 ECHA (2022), 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, available at: report_welding_fumes_en.pdf (europa.eu) |
| 8 ACSH (2023), Opinion on introducing work involving exposure to fumes from welding processes containing substances that meet the criteria for CMR category 1A/1B set out in Annex I to the CLP Regulation, Doc. 006/23, available at: ACSH Adopted opinion Welding fumes 22.09.23-EN.pdf (europa.eu) | 8 ACSH (2023), Opinion on introducing work involving exposure to fumes from welding processes containing substances that meet the criteria for CMR category 1A/1B set out in Annex I to the CLP Regulation, Doc. 006/23, available at: ACSH Adopted opinion Welding fumes 22.09.23-EN.pdf (europa.eu) |
Or. en
Amendment 38
Nora Mebarek, Estelle Ceulemans, Marc Angel, Johan Danielsson
Proposal for a directive
Recital 3
| Text proposed by the Commission | Amendment |
|---|---|
| (3) The IARC classified welding fumes as ‘carcinogenic to humans’ (Group 1 of the IARC classification). According to the ECHA scoping study7 , welding fumes 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 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 fumes from welding processes 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. | (3) The IARC classified welding fumes as ‘carcinogenic to humans’ (Group 1 of the IARC classification). According to the ECHA scoping study7 , welding fumes 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 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 fumes from welding processes 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. It is also appropriate to undertake further measures, that are also recommended by the ACSH opinion, such as the establishment of a general dust limit in Directive 98/24/EC and the development of guidance on welding fumes to specify in more detail the provisions laid down in Annex I to Directive 2004/37/EC. In addition, to reduce welding fume and improve the protection of workers, the Commission should promote existing best practices and support exchanges among Member States. |
| 7 ECHA (2022), 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, available at: report_welding_fumes_en.pdf (europa.eu) | 7 ECHA (2022), 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, available at: report_welding_fumes_en.pdf (europa.eu) |
| 8 ACSH (2023), Opinion on introducing work involving exposure to fumes from welding processes containing substances that meet the criteria for CMR category 1A/1B set out in Annex I to the CLP Regulation, Doc. 006/23, available at: ACSH Adopted opinion Welding fumes 22.09.23-EN.pdf (europa.eu) | 8 ACSH (2023), Opinion on introducing work involving exposure to fumes from welding processes containing substances that meet the criteria for CMR category 1A/1B set out in Annex I to the CLP Regulation, Doc. 006/23, available at: ACSH Adopted opinion Welding fumes 22.09.23-EN.pdf (europa.eu) |
Or. en
Amendment 39
Grégory Allione, Valérie Devaux, Jana Toom, Hristo Petrov, Martin Hojsík
Proposal for a directive
Recital 3 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (3 a) In its opinion of 22 September 2023 on welding fumes, the ACSH strongly recommended the development of 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 Inspectorate Committee in 2018, further guidance, on the basis of the latest scientific evidence, may be crucial in assisting labour inspectors and enterprises, especially SMEs including microenterprises, in ensuring compliance with the relevant 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 for all workers exposed to welding fumes across the Member States. It is also appropriate for the Commission to prioritise the assessment of the usefulness of further guidance in the context of evaluating the current EU Strategic Framework on Health and Safety at Work and developing the possible post-2027 EU Strategic Framework. |
Or. en
Amendment 40
Nora Mebarek, Estelle Ceulemans, Marc Angel, Johan Danielsson
Proposal for a directive
Recital 6
| Text proposed by the Commission | Amendment |
|---|---|
| (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. | (6) For cobalt and its inorganic compounds, it is foreseeable that it may 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 with just technical and organisational measures, although compliance with the limit value will in any case be achievable through the use of personal protective equipment as last resort. 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. Employers using cobalt and its inorganic compounds at the place of work must endeavour to actively seek substitution processes during the transition period in order to enable safer alternatives in the long term and comply with the limit values within the timeframe provided for in this Directive. |
Or. en
Amendment 41
Per Clausen
Proposal for a directive
Recital 6
| Text proposed by the Commission | Amendment |
|---|---|
| (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. | (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. Furthermore, the ACSH advises that, at the latest 13 years after entry into force of this Directive, the Commission should have the result of a study assessing the feasibility to further reduce the respirable OEL to a level corresponding to a residual risk of 4 : 10000 and to check the need of reducing further the inhalable fraction. This enables gaining experience with the OELs of 10 μg/m³ for the inhalable fraction and 2.5 μg/m³ for the respirable fraction. This study should take into account the RAC opinion of 2022 and any new relevant information. On the basis of the results of that study, the ACSH advises that the Commission should propose, where appropriate, necessary amendments related to cobalt and its inorganic compounds without delay. |
Or. en
Justification
This AM is from the ACSH recommendation on cobalt. It underlines the consensus in the ACSH to further lowering the OEL over time. This stands in contrast to the Rapporteur’s suggestion to make the transition period permanent. The Commission’s ‘Methodology establishing risk-based limit values for non-threshold carcinogens’ (p.6), stresses that the max. OEL (i.e. 1:4000, equivalent OEL suggested by the Rapporteur) should only be possible in transition periods and not permanently constrastic the Rapporteur’s AM3.
Amendment 42
Grégory Allione, Valérie Devaux, Jana Toom, Hristo Petrov
Proposal for a directive
Recital 6
| Text proposed by the Commission | Amendment |
|---|---|
| (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. | (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, there is a need to use respiratory protective equipment (RPE) to ensure that the workers are appropriately protected. |
Or. en
Amendment 43
Grégory Allione, Valérie Devaux, Jana Toom, Hristo Petrov
Proposal for a directive
Recital 6 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (6 a) In accordance with the opinion of the ACSH, no later than 13 years after this Directive enters into force, it is recommended for the Commission to have the results of a study assessing the feasibility to further reduce the respirable OEL to a level corresponding to a residual risk of 4:10000, and to check the need of reducing further the inhalable fraction. This would enable gaining experience with the OELs of 10 µg/m³ for the inhalable fraction and 2.5 µg/m³ for the respirable fraction. This study should take into account the 2022 RAC opinion and any new relevant information. On the basis of the results of this study, it is recommended that the Commission proposes, where appropriate and without delay, the necessary amendments and adjustments concerning cobalt and its inorganic compounds. |
Or. en
Amendment 44
Nora Mebarek, Estelle Ceulemans, Marc Angel, Johan Danielsson
Proposal for a directive
Recital 8
| Text proposed by the Commission | Amendment |
|---|---|
| (8) For PAHs mixtures, it is foreseeable that it will be difficult for some sectors to comply with a limit value of 0,00007 mg/m³ (measured as benzo(a)pyrene) 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 value of 0,00014 mg/m³ (measured as benzo(a)pyrene) should apply. That transitional period should be limited to the following sectors: (a) steel and iron foundries, which includes ferroalloy manufacturers; (b) aluminium manufacturers; (c) carbon and graphite electrode manufacturers; (d) coking plants; (e) coal tar distillation; (f) refractory products manufacturers; (g) welding of train tracks; (h) other non-ferrous metallurgical processes; and (i) casting of metals. | (8) For PAHs mixtures, it is foreseeable that it will be difficult for some sectors to comply with a limit value of 0,00007 mg/m³ (measured as benzo(a)pyrene) 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 value of 0,00014 mg/m³ (measured as benzo(a)pyrene) should apply. That transitional period should be limited to the following sectors: (a) steel and iron foundries, which includes ferroalloy manufacturers; (b) aluminium manufacturers; (c) carbon and graphite electrode manufacturers; (d) coking plants; (e) coal tar distillation; (f) refractory products manufacturers; (g) welding of train tracks; (h) other non-ferrous metallurgical processes; and (i) casting of metals. Employers using PAHs mixtures at the place of work within those sectors must endeavour to actively seek substitution processes during the transitional period in order to enable safer alternatives in the long term and comply with the limit value in the timeframe provided for in this Directive. Further, this transitional period should not be construed as justification for delayed prevention for workers in other sectors affected by PAHs mixtures, such as firefighters and emergency services. |
Or. en
Amendment 45
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Recital 8 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (8 a) 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 |
Or. en
Amendment 46
Grégory Allione, Valérie Devaux, Jana Toom, Hristo Petrov, Martin Hojsík
Proposal for a directive
Recital 8 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (8 a) 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 RAC and ACSH opinions, to establish a longterm occupational exposure limit value of 8,5 mg/m3 (3 ppm). |
Or. en
Amendment 47
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Recital 8 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (8 b) 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. |
Or. en
Amendment 48
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Recital 9
| Text proposed by the Commission | Amendment |
|---|---|
| (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, at the end of exposure or shift. | (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. |
| 12 https://echa.europa.eu/oels-activity-list/-/substance-rev/61801 | 12 https://echa.europa.eu/oels-activity-list/-/substance-rev/61801 |
Or. en
Amendment 49
Per Clausen
Proposal for a directive
Recital 9 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (9 a) Isoprene meets the criteria for classification as a carcinogen (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 and the opinions of the RAC and the ACSH, to establish a long-term occupational exposure limit value of 8,5 mg/m³ (3 ppm). |
Or. en
Amendment 50
Per Clausen
Proposal for a directive
Recital 9 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (9 b) 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. |
Or. en
Amendment 51
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Recital 11
| Text proposed by the Commission | Amendment |
|---|---|
| (11) 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-Making13 . When establishing or revising limit values, the Commission should consult the RAC and the ACSH to ensure that they are evidence-based, proportionate and measurable. | (11) 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-Making13 . When establishing or revising limit values, the Commission should consult the RAC and the ACSH to ensure that they are evidence-based, proportionate and measurable. The advice provided by both RAC and the ACSH are crucial, particularly the ACSH tripartite consensus that has been reached by governments and social partners. Their expert opinions, which are based on scientific evidence, practical experience and workplace realities across the Union, reflect broad support, thereby strengthening the validity of their advice, and improving the effectiveness of implementation in Member States. |
| 13 OJ L 123, 12.5.2016, p. 1. | 13 OJ L 123, 12.5.2016, p. 1. |
Or. en
Amendment 52
Grégory Allione, Valérie Devaux, Jana Toom, Hristo Petrov, Martin Hojsík
Proposal for a directive
Recital 11 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (11a) Firefighters and emergency services personnel are at risk of exposure to carcinogens, mutagens and reprotoxic substances in the course of their work. The World Health Organization has classified the occupational exposure of firefighters as carcinogenic. Preventive measures are therefore of key importance, and this revision should strengthen the protection of firefighters against polycyclic aromatic hydrocarbons (PAHs). Important guidance has been developed on risks arising from asbestos exposure, including sector-specific guidance for firefighters and emergency services personnel. In addition to the necessary preventive measures provided in this directive, the Commission should consult the ACSH on the need to update its Recommendation (EU) 2022/23371a on the European schedule of occupational diseases, with a view to encouraging Member States to introduce enhanced prevention measures at the occupational level and provisions allowing for better compensation for conditions suspected to be linked to occupational exposure in certain professions. | |
| 1a Commission Recommendation (EU) 2022/2337 of 28 November 2022 concerning the European schedule of occupational diseases (OJ L 309, 30.11.2022, p. 12, ELI: http://data.europa.eu/eli/reco/2022/2337/oj). |
Or. en
Amendment 53
Nora Mebarek, Estelle Ceulemans, Marc Angel, Johan Danielsson
Proposal for a directive
Recital 12 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12a) 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. 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, as is ensuring a high level of human health protection, preventing physical illness and diseases, and obviating sources of danger to physical health in accordance with Article 168(1) TFEU, while Principle 10 of the European Pillar of Social Rights 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. The impact assessment carried out by the Commission confirms that measures proposed in this Directive - and approved by the social partners following consultations within the framework of the ACSH - ensure a balanced approach, minimising economic disadvantages to businesses and disruptions, while providing for adequate protection of workers at Union level and being consistent with the Union's key objectives, including its strategic autonomy, Europe’s Beating Cancer Plan, and the twin transition. Therefore no exemptions to the limit values set for cobalt and its inorganic compounds should be considered in the future, while the ACSH advises to check the need of reducing further the limit values no later than 13 years after entry into force of the Directive. |
Or. en
Amendment 54
Per Clausen
Proposal for a directive
Recital 12 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (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 in all enterprises, notably SMEs including microenterprises . Therefore, Member States should maintain equal protection for all workers and facilitate compliance of SMEs including microenterprises. Against that background, specific measures, such as financial and administrative support, could help SMEs including microenterprises to further 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. |
Or. en
Amendment 55
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Recital 12 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 b) Cobalt is used in several sectors of strategic importance to reach the goals set out in the European Green Deal and Union Climate Law. While key for a successful industrial transition and to stimulate the circular economy, cobalt is also a hazardous metal posing serious health risks to workers, such as respiratory problems, heart, thyroid, liver or kidney damage and potential cancer. 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. |
Or. en
Amendment 56
Nora Mebarek, Estelle Ceulemans, Marc Angel, Johan Danielsson
Proposal for a directive
Recital 12 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 b) 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 should provide guidance on how inspectors and employers should evaluate compliance and prevention where multiple carcinogens co-occur. |
Or. en
Amendment 57
Per Clausen
Proposal for a directive
Recital 12 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 b) Cobalt is used in several sectors to reach the goals set out in the European Green Deal and the Union Climate Law, such as the batteries sector. Cobalt consumption is projected to rise by approximately 330 % by 2050 as a result of the green transition 1a, making it particularly important to ensure a high level of protection of workers’ health and safety. | |
| 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 |
Or. en
Amendment 58
Nora Mebarek, Estelle Ceulemans, Marc Angel, Johan Danielsson
Proposal for a directive
Recital 12 c (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 c) 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. |
Or. en
Amendment 59
Per Clausen
Proposal for a directive
Recital 12 c (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 c) Because of the harmful properties of cobalt and its inorganic compounds, it is essential to ensure that cobalt and cobalt-containing materials placed on the Union market are produced under occupational safety and health conditions that guarantee a level of protection for workers equivalent to that required within the Union, including when such materials originate from third countries. |
Or. en
Amendment 60
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Recital 12 c (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 c) 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. |
Or. en
Amendment 61
Nora Mebarek, Estelle Ceulemans, Marc Angel, Johan Danielsson
Proposal for a directive
Recital 12 d (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 d) For the majority of carcinogenic substances, it is not possible to identify a safe level of exposure by inhalation at the workplace below which no cancer risk would exist (a so-called ‘threshold’). For those non-threshold carcinogens, when binding OELs are set under Directive 2004/37/EC, the limit values are still associated with a residual risk. Many such non-threshold carcinogens cannot be eliminated or substituted, and minimising and transparently communicating the remaining risks to workers is therefore necessary. The residual risk is defined as the excess lifetime risk of cancer corresponding to a given binding OEL on the basis of a scientific assessment of the relationship between a given exposure and the predicted cancer cases (Exposure Risk Relationship). Residual risks differ from one binding OEL to another, inter alia, because socio-economic aspects are taken into account in the process of setting binding OELs. The residual risk is expressed as the number of additional cancer cases (additional to the expected number without exposure) that are statistically expected when a cohort of workers are exposed to the substance at an exposure level corresponding to the binding OEL throughout their working life (8 hours per day, 5 days per week, 40-year career). |
Or. en
Amendment 62
Per Clausen
Proposal for a directive
Recital 12 d (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12d) The primary objective of this Directive is to ensure a high level of protection of workers against risks to their health and safety arising from exposure to carcinogens, mutagens and reprotoxic substances at the workplace. Considerations related to industrial policy, supply chains or strategic interests of the Union should not lead to any lowering of that level of protection. The establishment, revision and implementation of occupational exposure limit values should therefore be primarily guided by the need to prevent occupational diseases and protect workers’ health. |
Or. en
Amendment 63
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Recital 12 d (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 d) The limit values established in this Directive 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. |
Or. en
Amendment 64
Per Clausen
Proposal for a directive
Recital 12 e (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 e) Workers are often exposed to a mixture of several 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. The Commission and Member States should support and promote the application of a mixture-risk approach in workplace risk assessments and prevention measures, including by providing guidance and by encouraging the development and use of appropriate methodologies and tools to address combined exposures. |
Or. en
Amendment 65
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Recital 12 e (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 e) To ensure a comprehensive level of protection, it is necessary to consider the effects of combined exposure to multiple substances. In the workplace, workers are often exposed to a cocktail of hazardous substances, 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. |
Or. en
Amendment 66
Nora Mebarek, Estelle Ceulemans, Marc Angel, Johan Danielsson
Proposal for a directive
Recital 12 e (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 e) A list of residual risks associated with the existing binding OELs for carcinogens under Directive 2004/37/EC and the Directive 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. |
Or. en
Amendment 67
Per Clausen
Proposal for a directive
Recital 12 f (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 f) Firefighters and emergency services personnel are at risk of exposure to carcinogens, mutagens and reprotoxic substances in the course of their work. The World Health Organization has classified the occupational exposure of firefighters as carcinogenic. The occupational exposure of firefighters includes a variety of hazards resulting from fires and from non-fire events. It is therefore important that the employers of firefighters, including volunteer firefighters and emergency services personnel assess, in accordance with Directive 2004/37/EC, 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. |
Or. en
Amendment 68
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Recital 12 f (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 f) 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). |
Or. en
Amendment 69
Nora Mebarek, Estelle Ceulemans, Marc Angel, Johan Danielsson
Proposal for a directive
Recital 12 f (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 f) Isoprene meets the criteria for classification as carcinogenic (category 1B) provided for in 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). This OEL can enter into force without any transitional measures. | |
| 1a https://echa.europa.eu/oels-activity-list/-/substance-rev/62301/term |
Or. en
Amendment 70
Nora Mebarek, Estelle Ceulemans, Marc Angel, Johan Danielsson
Proposal for a directive
Recital 12 f (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 f) The limit values established in Directive 2004/37/EC should be kept under regular scrutiny and strictly reviewed at least every five years on the basis of advances in knowledge and technologies, with mind to, where appropriate, propose further reduction of occupational exposure limit values. |
Or. en
Amendment 71
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Recital 12 g (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 g) Firefighters and emergency services personnel are at risk of exposure to carcinogens, mutagens and reprotoxic substances in the course of their work. In July 2022 the IARC, a World Health Organization body, classified the occupational exposure of firefighters as carcinogenic. The occupational exposure of firefighters includes a variety of hazards resulting from fires and from non-fire events. It is therefore important that the employers of firefighters, including volunteer firefighters, and emergency services personnel assess, in accordance with Directive 2004/37/EC, 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. 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 span across both dermal and airborne exposure routes. Employers of firefighters should implement preventive and protective measures on the basis of this guidance, as well as facilitate systematic medical surveillance, particularly after peak events, in order to better monitor medical pathways and improve health hazard data collection. Such data will contribute to future revisions and adjustments of this directive, ensuring better health and safety for those workers. |
Or. en
Amendment 72
Per Clausen
Proposal for a directive
Recital 12 g (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 g) Gender-specific differences in exposure patterns, physiological susceptibility and health outcomes remain insufficiently reflected in occupational safety and health research, particularly in relation to chemical risks. The Commission should therefore include a systematic integration of the gender dimension in assessments of future amendments to Directive 2004/37/EC. |
Or. en
Amendment 73
Nora Mebarek, Estelle Ceulemans, Marc Angel, Johan Danielsson
Proposal for a directive
Recital 12 g (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 g) Since this Directive concerns the protection of the health and safety of workers at the place of work, it should be transposed within two years of the date of its entry into force. |
Or. en
Amendment 74
Per Clausen
Proposal for a directive
Recital 12 h (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 h) The establishment of occupational exposure limit values is an inherently political task, requiring the balancing of scientific evidence, socioeconomic considerations, technical feasibility and the protection of workers’ fundamental rights. Those decisions determine the level of health protection afforded to millions of workers across the Union and must therefore remain within a fully transparent democratic process subject to public scrutiny and parliamentary oversight. The current procedure, which involves the Commission, the Member States, the ACSH and the European Parliament as co-legislator, ensures that the adoption of limit values reflects political responsibility rather than automatic technical updating. It is therefore appropriate that decisions of such importance continue to be taken through the ordinary legislative procedure and not through simplified procedures intended only for uniform implementation or non-essential modifications of legislation. |
Or. en
Justification
Justification: Setting limit values for non-threshold substances under this directive (i.e. non-threshold carcinogens) means deciding on the level of risks (residual cancer cases) that is acceptable to exposed workers. This is an essential element of Directive 2004/37/EC. It is always a societal and political decision and certainly not a technical decision.
Amendment 75
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Recital 12 h (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 h) 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. |
Or. en
Amendment 76
Nora Mebarek, Estelle Ceulemans, Marc Angel
Proposal for a directive
Recital 12 i (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 i) 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 recommends that the Commission use this list when selecting chemicals for developing legislative proposals for new, or revised, limit values under the CMRD. | |
| 1a ACSH document 006-24, https://circabc.europa.eu/ui/group/cb9293be-4563-4f19-89cf-4c4588bd6541/library/1c3986a7-b583-4382-a6bc-d712eace2b47/details |
Or. en
Amendment 77
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Recital 12 i (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 i) Workers can be more exposed and more vulnerable to different types of substances depending on their gender, and this should be reflected in occupational health and safety research. Gender mainstreaming shall be an integral part of the development of all occupational safety and health policies and prevention strategies at Union level. The Commission’s impact assessments should look at the health consequences for workers of all substances disaggregated by gender and the Commission should systematically integrate the gender dimension in the future amendments to Directive 2004/37/EC. |
Or. en
Amendment 78
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Recital 12 j (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 j) Although binding OELs are set by Directive 2004/37/EC for non-threshold carcinogens, limit values are still associated with a residual risk. As many of such carcinogens cannot be eliminated, substituted or minimised, transparently communicating the remaining risks to workers is therefore regarded as necessary. |
Or. en
Justification
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
Amendment 79
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Recital 12 k (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12 k) 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. However, those values do not completely eliminate the risks associated with exposure. Setting limit values, and, consequently, the level of residual risks associated with them is not a matter of solely technical consideration, but requires political assessment as well as political decision. The ordinary legislative procedure involving both the European Parliament and the Council to set binding limit values under Directive 2004/37/ EC are therefore essential in this regard. |
Or. en
Amendment 80
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Article 1 – paragraph 1 – point -1 (new)
Directive 2004/37/EC
Article 2 – paragraph 1 – point a – point ii
| Present text | Amendment |
|---|---|
| (-1) in Article 2, point (a)(ii) is replaced by the following: | |
| (ii) a substance, mixture or process referred to in Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex; | ‘(ii) a substance, mixture or process referred to in Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex, included in the list set out in that Annex because of its carcinogenic effects;’ |
Or. en
Amendment 81
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Article 1 – paragraph 1 – point -1 a (new)
Directive 2004/37/EC
Article 2 – paragraph 1 – point b – point ii
| Present text | Amendment |
|---|---|
| (-1a) in Article 2, point (b)(ii) is replaced by the following: | |
| (ii) a substance, mixture or process referred to in Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex; | ‘(ii) a substance, mixture or process referred to in Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex, included in the list set out in that Annex because of its carcinogenic effects;’ |
Or. en
Amendment 82
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Article 1 – paragraph 1 – point -1 b (new)
Directive 2004/37/EC
Article 2 – paragraph 1 – point ba
| Present text | Amendment |
|---|---|
| (-1b) in Article 2, point (ba) is replaced by the following: | |
| (ba) ‘reprotoxic substance’ means 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; | ‘(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 Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex, included in the list set out in that Annex because of its reprotoxic effects;’ |
Or. en
Amendment 83
Per Clausen
Proposal for a directive
Article 1 – paragraph 1 – point -1 b (new)
Directive 2004/37/EC
Article 2 – paragraph 1 – point e a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1b) 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.’ |
Or. en
Amendment 84
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Article 1 – paragraph 1 – point -1 b (new)
Directive 2004/37/EC
Article 2 – paragraph 1 – point e a (new)
| Present text | Amendment |
|---|---|
| (-1b) 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.’ |
Or. en
Amendment 85
Nora Mebarek, Estelle Ceulemans, Marc Angel, Johan Danielsson
Proposal for a directive
Article 1 – paragraph 1 – point -1 b (new)
Directive 2004/37/EC
Article 2 – paragraph 1 – point e a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1b) 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.’ |
Or. en
Amendment 86
Maria Ohisalo
Proposal for a directive
Article 1 – paragraph 1 – point -1 c (new)
Directive 2004/37/EC
Article 2 – paragraph 1 – point e b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1c) 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.’ |
Or. en
Amendment 87
Nora Mebarek, Estelle Ceulemans, Marc Angel, Johan Danielsson
Proposal for a directive
Article 1 – paragraph 1 – point -1 c (new)
Directive 2004/37/EC
Article 2 – point e b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1c)_ in Article 2, the following point is added: | |
| '(eb) “medicinal products” means medicinal products as defined in Article 1, point 2, of Directive 2001/83/EC.’ |
Or. en
Amendment 88
Grégory Allione, Valérie Devaux, Jana Toom, Hristo Petrov, Martin Hojsík
Proposal for a directive
Article 1 – paragraph 1 – point -1 d (new)
Directive 2004/37/EC
Article 5 – paragraph 5 – point g
| Present text | Amendment |
|---|---|
| (-1d) in Article 5(5), point (g) is replaced by the following: | |
| (g) collective protection measures and/or, where exposure cannot be avoided by other means, individual protection measures; | ‘(g) collective protection measures and/or, where exposure cannot be avoided by other means, individual protection measures, which shall be appropriately handled and, in particular with regard to respiratory equipment, which shall be individually adjusted, including through fitting checks, in accordance with Council Directive 89/656/EEC;’ |
Or. en
Amendment 89
Raúl de la Hoz Quintano, Maravillas Abadía Jover, Markus Ferber, Andrea Wechsler, Marion Walsmann
Proposal for a directive
Article 1 – paragraph 1 – point -1 e (new)
Directive 2004/37/EC
Article 5 – paragraph 5 a (new)
| Present text | Amendment |
|---|---|
| (-1e) in Article 5, the following paragraph is added: | |
| ‘5a. Personal Protective Equipment (PPE) shall be used when all possible technical and organisational measures have been put in place in accordance with the hierarchy of controls to eliminate or minimise workers’ exposure as specified in this Article, but residual exposure still occurs and cannot be reduced to levels below the limit set out in Annex III. In such cases, compliance with the applicable limit value for the carcinogenic, mutagenic and reprotoxic substance shall be determined taking into account the protection afforded by correctly selected, fitted and maintained PPE.’ |
Or. en
Amendment 90
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Article 1 – paragraph 1 – point -1 f (new)
Directive 2004/37/EC
Article 10 – paragraph 2 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1f) in Article 10, the following paragraph is added: | |
| ‘2a. Workers shall be entitled to proportionate and regular breaks when wearing protective equipment.’ |
Or. en
Amendment 91
Per Clausen
Proposal for a directive
Article 1 – paragraph 1 – point -1 f (new)
Directive 2004/37/EC
Article 10 – paragraph 2 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1f) in Article 10, the following paragraph is added: | |
| ‘2a. Workers shall be entitled to proportionate and regular breaks in a protected space when wearing protective equipment.’; |
Or. en
Amendment 92
Nora Mebarek, Estelle Ceulemans, Marc Angel, Johan Danielsson
Proposal for a directive
Article 1 – paragraph 1 – point -1 g (new)
Directive 2004/37/EC
Article 18 a – point 1
| Present text | Amendment |
|---|---|
| (-1g) in Article 18a, point 1 is replaced by the following | |
| 1. The Commission shall, as part of the next evaluation of the implementation of this Directive in the context of the evaluation referred to in Article 17a of Directive 89/391/EEC, also evaluate the need to modify the limit value for respirable crystalline silica dust. The Commission shall launch this process in 2022 and, where appropriate, shall subsequently propose necessary amendments and modifications related to that substance in a subsequent revision of this Directive | ‘1. The Commission shall, as part of the next revision of this Directive propose a lower limit value for respirable crystalline silica dust, after consulting the Advisory Committee for Safety and Health at Work (ACSH) and taking into account its recommendation.’ |
Or. en
Amendment 93
Per Clausen
Proposal for a directive
Article 1 – paragraph 1 – point -1 h (new)
Directive 2004/37/EC
Article 18 a – point 6 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (1h) in Article 18a, the following point is inserted: | |
| ‘6a. No later than 30 June 2027, the Commission shall, taking into account the latest developments in scientific knowledge, and after appropriate consultation of relevant stakeholders, propose, where appropriate, a limit value for carcinogenic substances in jet exhaust.’ |
Or. en
Amendment 94
Per Clausen
Proposal for a directive
Article 1 – paragraph 1 – point -1 i (new)
Directive 2004/37/EC
Article 18 a – point 7
| Text proposed by the Commission | Amendment |
|---|---|
| (-1i) in Article 18a, point 7 is deleted. |
Or. en
Justification
This text is simply outdated and is left over from the previous CMRD revision and thereby already adopted.
Amendment 95
Nora Mebarek, Estelle Ceulemans, Marc Angel, Johan Danielsson
Proposal for a directive
Article 1 – paragraph 1 – point -1 j (new)
Directive 2004/37/EC
Article 18 a – point 7
| Present text | Amendment |
|---|---|
| (1j) in Article 18a, point 7 is replaced by the following : | |
| 7. No later than 31 December 2024, the Commission shall, taking into account the latest developments in scientific knowledge, and after appropriate consultation of relevant stakeholders, propose, where appropriate, a limit value for cobalt and inorganic cobalt compounds. | ‘7. No later than ... [13 years after the date of entry into force of this Directive], the Commission shall, taking into account the latest developments in scientific knowledge and technological innovations, and after appropriate consultation of relevant stakeholders, propose lower limit values for cobalt and inorganic cobalt compounds than provided for in this Directive.’ |
Or. en
Amendment 96
Grégory Allione, Valérie Devaux, Jana Toom, Hristo Petrov, Martin Hojsík
Proposal for a directive
Article 1 – paragraph 1 – point -1 k (new)
Directive 2004/37/EC
Article 18 a – point 11 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1k) in Article 18a, the following point 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.’ |
Or. en
Amendment 97
Per Clausen
Proposal for a directive
Article 1 – paragraph 1 – point -1 k (new)
Directive 2004/37/EC
Article 18 a – point 11 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1k) in Article 18a, the following point is added: | |
| ‘11a. The Commission’s proposal shall include ‘work involving exposure to aircraft engine emissions’ in Annex I of Directive 2004/37/EC.’ |
Or. en
Amendment 98
Per Clausen
Proposal for a directive
Article 1 – paragraph 1 – point -1 k (new)
Directive 2004/37/EC
Article 18 a – point 11 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1k) in Article 18a, the following point is added: | |
| ‘(11b) No later than 1 December 2026, 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.’ |
Or. en
Justification
After the inclusion of a specific entry in Annex I to Directive 2004/37/EC for work involving exposure to fumes from welding processes containing substances that meet the criteria for classification as category 1A or 1B carcinogen, mutagen or reprotoxic set out in Annex I to Regulation (EC) No 1272/2008, it is important to improve the health and safety of workers exposed to these welding fumes to complement the entry in Annex I with corresponding limit value(s) in Annex III.
Amendment 99
Nora Mebarek, Estelle Ceulemans, Marc Angel, Johan Danielsson
Proposal for a directive
Article 2 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by […] [The time limit for transposition will be as short as possible and, generally, will not exceed two years] at the latest. They shall immediately inform the Commission thereof. | 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. |
Or. en
Amendment 100
Per Clausen
Proposal for a directive
Article 2 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by […] [The time limit for transposition will be as short as possible and, generally, will not exceed two years] at the latest. They shall immediately inform the Commission thereof. | 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] at the latest. They shall immediately inform the Commission thereof. |
Or. en
Amendment 101
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Annex – paragraph 1 – point -1 (new)
Directive 2004/37/EC
Annex I – title
| Present text | Amendment |
|---|---|
| (-1) in Annex I, the title is replaced by the following: | |
| List of substances, mixtures and processes (Article 2, points (a)(ii) and (b)(ii)) | List of substances, mixtures and processes (Article 2, points (a)(ii), (b)(ii) and (ba)(ii)) |
Or. en
Amendment 102
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Annex – paragraph 1 – point 1
Directive 2004/37/EC
Annex I – point 9
| Text proposed by the Commission | Amendment |
|---|---|
| 9. Work involving exposure to fumes from welding processes 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 1272/20081 ; | 9. Work involving exposure to fumes from welding and from processes that generate fumes in a similar way, containing substances or mixtures that meet the criteria 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 1272/20081 ; |
| 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. | 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. |
Or. en
Amendment 103
Mariateresa Vivaldini, Francesco Torselli, Elena Donazzan; Chiara Gemma
Proposal for a directive
Annex – paragraph 1 – point 1
Directive 2004/37/EC
Annex I – point 9
| Text proposed by the Commission | Amendment |
|---|---|
| 9. Work involving exposure to fumes from welding processes 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 1272/20081 ; | 9. Work involving exposure to fumes from welding and associated processes 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 1272/20081 ; |
| 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. | 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. |
Or. en
Amendment 104
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Annex – paragraph 1 – point 1
Directive 2004/37/EC
Annex 1 – point 9 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 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) No1272/2008. |
Or. en
Amendment 105
Per Clausen
Proposal for a directive
Annex – paragraph 1 – point 1
Directive 2004/37/EC
Annex I – point 9 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 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. |
Or. en
Amendment 106
Nora Mebarek, Estelle Ceulemans, Marc Angel, Johan Danielsson
Proposal for a directive
Annex – paragraph 1 – point 1
Directive 2004/37/EC
Annex I – point 9 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 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. |
Or. en
Amendment 107
Mariateresa Vivaldini, Francesco Torselli, Elena Donazzan; Chiara Gemma
Proposal for a directive
Annex – paragraph 1 – point 2 – point a
Directive 2024/37/EC
Annex III – point A – row 21
| Text proposed by the Commission | ||||||||||
| Limit values | ||||||||||
| 8 hours (3) | Short-term (4) | |||||||||
| Name of agent | EC No (1) | CAS No (2) | mg/m3 (5) | ppm (6) | f/ml(7) | mg/m3 | ppm | f/ml | Notation | Transitional measures |
| Polycyclic aromatic hydrocarbons mixtures, particularly those containing benzo[a]pyrene, which are carcinogens, mutagens or reprotoxicants within the meaning of this Directive | 0,00007(*2) | Skin (10) | Limit value 0,00014(*2) until …[OJ: six years after the date of entry into force of the amending Directive] limited to the following sectors: (1) steel and iron foundries, which includes ferroalloy manufacturers, (2) aluminium manufacturers, (3) carbon and graphite electrode manufacturers, (4) coking plants, (5) coal tar distillation, (6) refractory products manufacturers, (7) welding of train tracks, (8) other non-ferrous metallurgical processes, and (9) casting of metals. | |||||||
| 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. Amendment | ||||||||||
| Limit values | ||||||||||
| 8 hours (3) | Short-term (4) | |||||||||
| Name of agent | EC No (1) | CAS No (2) | mg/m3 (5) | ppm (6) | f/ml(7) | mg/m3 | ppm | f/ml | Notation | Transitional measures |
| Polycyclic aromatic hydrocarbons mixtures, particularly those containing benzo[a]pyrene, which are carcinogens, mutagens or reprotoxicants within the meaning of this Directive | 0,00007(*2) | Skin (10) | Limit value 0,00014(*2) until …[OJ: six years after the date of entry into force of the amending Directive] limited to the following sectors: (1) steel and iron foundries, which includes ferroalloy manufacturers, (2) aluminium manufacturers, (3) carbon and graphite electrode manufacturers, (4) coking plants, (5) coal tar distillation, (6) refractory products manufacturers, (7) welding of train tracks, (8) other non-ferrous metallurgical processes, and (9) casting of metals and (10) construction sector. |
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.
Or. en
Amendment 108
Raúl de la Hoz Quintano, Maravillas Abadía Jover, Markus Ferber, Andrea Wechsler, Marion Walsmann
Proposal for a directive
Annex – paragraph 1 – point 2 – point a
Directive 2004/37/EC
Annex III – point A – row 21
| Text proposed by the Commission | ||||||||||
| Limit values | ||||||||||
| 8 hours (3) | Short-term (4) | |||||||||
| Name of agent | EC No (1) | CAS No (2) | mg/m3 (5) | ppm (6) | f/ml(7) | mg/m3 | ppm | f/ml | Notation | Transitional measures |
| Polycyclic aromatic hydrocarbons mixtures, particularly those containing benzo[a]pyrene, which are carcinogens, mutagens or reprotoxicants within the meaning of this Directive | 0,00007(*2) | Skin (10) | Limit value 0,00014(*2) until …[OJ: six years after the date of entry into force of the amending Directive] limited to the following sectors: (1) steel and iron foundries, which includes ferroalloy manufacturers, (2) aluminium manufacturers, (3) carbon and graphite electrode manufacturers, (4) coking plants, (5) coal tar distillation, (6) refractory products manufacturers, (7) welding of train tracks, (8) other non-ferrous metallurgical processes, and (9) casting of metals. | |||||||
| 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. Amendment | ||||||||||
| Limit values | ||||||||||
| 8 hours (3) | Short-term (4) | |||||||||
| Name of agent | EC No (1) | CAS No (2) | mg/m3 (5) | ppm (6) | f/ml(7) | mg/m3 | ppm | f/ml | Notation | Transitional measures |
| Polycyclic aromatic hydrocarbons mixtures, particularly those containing benzo[a]pyrene, which are carcinogens, mutagens or reprotoxicants within the meaning of this Directive | 0,00007(*2) | Skin (10) | Limit value 0,00014(*2) until …[OJ: ten years after the date of entry into force of the amending Directive] limited to the following sectors: (1) steel and iron foundries, which includes ferroalloy manufacturers, (2) aluminium manufacturers, (3) carbon and graphite manufacturers, (4) coking plants, (5) coal tar distillation, (6) refractory products manufacturers, (7) welding of train tracks, (8) other non-ferrous metallurgical processes, and (9) casting of metals. |
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.
Or. en
Amendment 109
Nora Mebarek, Estelle Ceulemans, Marc Angel, Johan Danielsson
Proposal for a directive
Annex – paragraph 1 – point 2 – point c
Directive 2004/37/EC
Annex III – point A – table – row 42 a (new)
| Text proposed by the Commission | ||||||||||
| Amendment | ||||||||||
| Name of agent | EC No (1) | CAS No (2) | mg/m3 (5) | ppm (6) | f/ml(7) | mg/m3 | ppm | f/ml | Notation | Transitional measures |
| Isoprene | 201-143-3 | 78-79-5 | 8,5 | 3 | - | - | - | - |
Or. en
Amendment 110
Grégory Allione, Valérie Devaux, Jana Toom, Hristo Petrov, Martin Hojsík
Proposal for a directive
Annex – paragraph 1 – point 2 – point c
Directive 2004/37/EC
Annex III – point A – table – row 42 a (new)
| Text proposed by the Commission | ||||||||||
| Amendment | ||||||||||
| Name of agent | EC No (1) | CAS No (2) | mg/m3 (5) | ppm (6) | f/ml(7) | mg/m3 | ppm | f/ml | Notation | Transitional measures |
| Isoprene | 201-143-3 | 78-79-5 | 8,5 | 3 | - | - | - | - |
Or. en
Amendment 111
Maria Ohisalo
Proposal for a directive
Annex – paragraph 1 – point 2 – point c
Directive 2004/37/EC
Annex III – point A – table – row 42 a (new)
| Text proposed by the Commission | ||||||||||
| Amendment | ||||||||||
| Name of agent | EC No (1) | CAS No (2) | mg/m3 (5) | ppm (6) | f/ml(7) | mg/m3 | ppm | f/ml | Notation | Transitional measures |
| Isoprene | 201-143-3 | 78-79-5 | 8,5 | 3 | - | - | - | - |
Or. en
Amendment 112
Per Clausen
Proposal for a directive
Annex – paragraph 1 – point 2 – point c
Directive 2004/37/EC
Annex III – point A – table – row 42 a (new)
| Text proposed by the Commission | ||||||||||
| Amendment | ||||||||||
| Name of agent | EC No (1) | CAS No (2) | mg/m3 (5) | ppm (6) | f/ml(7) | mg/m3 | ppm | f/ml | Notation | Transitional measures |
| Isoprene | 201-143-3 | 78-79-5 | 8,5 | 3 | - | - | - | - |
Or. en
Amendment 113
Maria Ohisalo
on behalf of the Verts/ALE Group
Proposal for a directive
Annex– paragraph 1 – point 3
Directive 2004/37/EC
Annex IIIa
| Text proposed by the Commission | Amendment |
|---|---|
| The binding biological limit value is 45 mg HEAA*in urine/g creatinine.’ | The binding biological limit value is 45 mg HEAA*in urine/g creatinine, measured at the end of exposure or shift. |
Or. en