What changed between the draft committee report and the plenary report

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

8 unchanged paragraphs

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

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

(Ordinary legislative procedure: first reading)

The European Parliament,

– having regard to the Commission proposal to Parliament and the Council (COM(2025)0418),

– having regard to Article 294(2) and Article 153 (1) and (2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C100180/2025),

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

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

Changed:– having regard to the report of the Committee on Employment and Social Affairs (A100000/2025),(A10-0100/2026),

1. Adopts its position at first reading hereinafter set out;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

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

Change 1

Removed:Recital 2: (2) Directive 2004/37/EC covers substances and mixtures which meet the criteria for classification as a category 1A or 1B carcinogen, mutagen or reprotoxic set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council6 as well as substances, mixtures and processes referred to in Annex I to that Directive. Robust scientific evidence is to be provided for any new addition to the list of substances, mixtures and processes referred to in that Annex I to demonstrate that these substances, mixtures and processes fall within the scope of Directive 2004/37/EC, based on available valid scientific sources such as the ECHA, the International Agency for Research on Cancer (IARC) and national bodies, paying particular attention to peer-reviewed published literature on those substances, mixtures and processes.

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

Change 2

Changed:Recital 3: (3) The IARC classified welding fumes as ‘carcinogenic to2: humans’(2) (GroupDirective 12004/37/EC ofcovers thesubstances IARCand classification).mixtures Accordingwhich tomeet the ECHA scoping study, fumes from welding and from processes thatcriteria generatefor fumesclassification inas a similar way, are complexcategory and1A mayor include1B carcinogens,carcinogen, mutagensmutagen or reprotoxic substances,set suchout asin chromium(VI)Annex compounds,I nickelto compounds,Regulation cadmium(EC) andNo its1272/2008 inorganicof compounds.the TheEuropean complexityParliament and heterogeneity of weldingthe andCouncil6 otheras fumes,well togetheras withsubstances, themixtures absenceand ofprocesses harmonisedreferred classificationto in the Regulation (EC) 1272/2008,Annex contributeI to athat lackDirective. ofRobust clarityscientific onevidence theiris possibleto dangerousnessbe provided for workers,any andnew thereforeaddition ato lackthe oflist appropriateof risksubstances, managementmixtures measuresand atprocesses thereferred workplace.to Addressingin that absence of classification for welding fumesAnnex atI Unionto leveldemonstrate wouldthat ensurethese moresubstances, legalmixtures clarityand inprocesses termsfall ofwithin the applicationscope of Directive 2004/37EC.2004/37/EC, Itbased ison thereforeavailable appropriate,valid inscientific linesources withsuch theas opinionthe ofECHA, the ACSHInternational ,Agency tofor includeResearch inon AnnexCancer I(IARC) toand Directivenational 2004/37/ECbodies, workpaying involvingparticular exposureattention to fumes from welding and from processespeer-reviewed thatpublished generateliterature fumeson inthose asubstances, similarmixtures way,and containingprocesses. substancesIt orremains mixturesessential that meet the criteria for classification asCommission aaccelerates categorythe 1Aprocedure orfor 1Bassessment carcinogen,of mutagenhazardous orsubstances, reprotoxicmixtures setand outprocesses, inwith Annexa Iview to Regulation (EC) No 1272/2008. That ACSH8 opinionsetting alsooccupational identifiedexposure thelimit needvalues for further measures to reducea healthgreater effectsnumber ofthereof exposureand toensuring particulatesthe fromhighest weldinglevel fumesof andprotection otherfor sources,workers, including theby establishmentincreasing ofthe ascientific generaland dustadministrative limitcapacity underof Councilall DirectiveUnion 98/24/EC8a.bodies Furthermo…involved.

Change 3

Removed:Recital 6: (6) For cobalt and its inorganic compounds, the limit values of 0,02 mg/m³ (inhalable fraction) and 0,0042 mg/m³ (respirable fraction) should apply.

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

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

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

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

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

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

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

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

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

Change 4

Removed:Recital 12 a (new): (12a) The employers' obligations laid down in this Directive should take into account the fact that microenterprises and SMEs, which represent a large majority of enterprises in the Union, have limited financial, technical and human resources. In order to ensure the highest possible protection of workers in all enterprises, Member States should assess the impact of the implementation of this Directive and the related administrative burden on those enterprises, in order to ensure that they are not disproportionately affected, with a specific focus on microenterprises, and to publish the results of such assessments. In doing so, Member States should maintain equal protection for all workers and facilitate compliance of microenterprises and SMEs. Against that background, specific measures, such as financial and administrative support, could help microenterprises and SMEs 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.

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

Removed:Recital 12 b (new): (12b) 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.

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

Removed:Recital 12 c (new): (12c) Because of the harmful properties of cobalt and its inorganic compounds, relocation of cobalt-processing enterprises to third countries with less stringent occupational safety and health regulations needs to be avoided at all times.

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

Removed:Recital 12 d (new): (12d) Some of the substances covered by this Directive, such as cobalt, are considered essential for safeguarding the Union’s strategic autonomy and ensuring the resilience of key industrial value chains. For those substances, in the absence of appropriate alternatives, the Commission should assess the socio-economic benefits arising from their continued use against the risks posed to workers in the relevant sectors. In light of evolving geopolitical realities and their potential impact on supply chains and strategic dependencies, such assessments should be reviewed at regular intervals. On the basis of those assessments, and in consultation with the social partners, the Commission should consider targeted and limited exemptions to existing or new limit values, strictly confined to activities where such uses remain indispensable for the Union’s strategic interests.

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

Removed:Recital 12 e (new): (12e) 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.

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

Removed:Recital 12 f (new): (12f) 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.

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

Change 5

Changed:Recital 1211 gc (new): (12g)(11c) Workers are often exposed to a cocktail of hazardous substances at the workplace, which can increase risks and cause adverse health effects. In the case of exposure to a combination of substances acting by the same mode of action or at the same target cell or tissue, it is necessary to adapt the implementation of their possible limit values to take into account the combined effects. This is particularly relevant for firefighters and emergency services personnel. The Commission and Member States should provide guidance on how inspectors and employers are to evaluate compliance and prevention where multiple carcinogens co-occur and encourage the development and use of appropriate methodologies and tools to address combined exposures.

Change 6

Removed:Recital 12 h (new): (12h) 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).

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

Removed:Recital 12 i (new): (12i) Isoprene 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 longterm occupational exposure limit value of 8,5 mg/m3 (3 ppm).

Added: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.

Removed:Recital 12 j (new): (12j) 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, 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.

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

Removed:Recital 12 k (new): (12k) There is a need for workers to receive sufficient and appropriate training 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.

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

Removed:Recital 12 l (new): (12l) 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 revisions of this Directive.

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

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

Directive 2004/37/EC

Change 7

Changed:Article 1 – paragraph 1 – point -1 (new), Article 2 – paragraph 1 – point a – point ii: (-1) Inin Article 2, point (a)(ii) is replaced by the following: / ‘(ii) a substance, mixture or process referred to in points 1 to 8 of Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex, included in the list set out in that Annex because of its carcinogenicthose effects;’;points;’

Added:(32004L0037 (Document 02004L0037-20240408))

Directive 2004/37/EC

Change 8

Changed:Article 1 – paragraph 1 – point -1 a (new), Article 2 – paragraph 1 – point ba – point ii:ii a (new): (-1a) Inin Article 2, point (b)(ii)a isnew replacedpoint by(a)(iia) theis following:added: / ‘(ii)‘(iia) a substance, mixture or process referred to in point 9 of Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex, included in the list set out in that Annexpoint, becausewhere ofit itshas carcinogenic effects;’;effects;’

Directive 2004/37/EC

Change 9

Changed:Article 1 – paragraph 1 – point -1 b (new), Article 2 – paragraph 1 – point ba:b – point ii: (-1b) Inin Article 2, point (ba)(b)(ii) is replaced by the following: / ‘(ba) ‘reprotoxic substance’ means: / (i)‘(ii) a substance orsubstance, mixture which meets the criteria for classification as a category 1A or 1B reproductive toxicantprocess setreferred outto in Annexpoints I1 to Regulation (EC) No 1272/2008; / (ii) a substance, mixture or process referred to8 inof 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 reprotoxicthose effects;’;points;’

Added:(32004L0037 (Document 02004L0037-20240408))

Directive 2004/37/EC

Change 10

Changed:Article 1 – paragraph 1 – point -1 c (new), Article 102 – paragraph 21 – point b – point ii a (new): (-1c) in Article 10,2, thea followingnew paragraphpoint (b)(iia) is added: / ‘2a.(iia) Workersa shallsubstance, bemixture entitledor process referred to proportionatein andpoint regular9 breaksof whenAnnex wearingI protectiveto equipment.’;this Directive as well as a substance or mixture released by a process referred to in that point, where it has mutagenic effects;