Changes between two versions
What changed between the draft committee report and the plenary report
From · draft committee report· 8 May 2023
on the proposal for a directive of the European Parliament and of the Council amending Council Directive 98/24/EC and Directive 2004/37/EC of the European Parliament and of the Council as regards the limit values for lead and its inorganic compounds and diisocyanates
To · plenary report· 8 Sept 2023
on the proposal for a directive of the European Parliament and of the Council amending Council Directive 98/24/EC and Directive 2004/37/EC of the European Parliament and of the Council as regards the limit values for lead and its inorganic compounds and diisocyanates
Changes to the text itself, in document order. Cover page, citations and punctuation-only edits are left out; they are under “Every difference”.
The changes · 30
Change 1
Removed:Recital 6: (6) Lead and its inorganic compounds are key occupational reprotoxicants that can affect both fertility and the development of the foetus and meet the criteria for classification as toxic for reproduction (category 1A) in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council and are therefore a reprotoxic substances within the meaning of Article 2, point (ba), of Directive 2004/37/EC. Studies show that lead accounts for around half of all occupational exposure to reprotoxic substances.
Added:Recital 1 a (new): (1a) Member States should maintain equal protection of all workers and should facilitate the compliance of SMEs and microenterprises with the obligations stemming from this Directive. SMEs and 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 and microenterprises, including 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 and microenterprises.
Removed:Recital 7: (7) Oral and inhalation exposure are both relevant routes for the uptake of lead and its inorganic compounds into the human body. Taking into account the most recent scientific data and new findings with regard to lead and its inorganic compounds, it is necessary to improve the protection of workers exposed to a potential health risk, by reducing both the occupational exposure and biological limit values for lead.
Added:Recital 6: (6) Lead and its inorganic compounds are key occupational reprotoxicants that can affect both fertility and the development of the foetus and meet the criteria for classification as toxic for reproduction (category 1A) in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council and are therefore a reprotoxic substances within the meaning of Article 2, point (ba), of Directive 2004/37/EC. Studies show that lead accounts for around half of all occupational exposure to reprotoxic substances. It is not scientifically possible to identify a level below which exposure to lead and its inorganic compounds would not have adverse health effects for the development of the offspring of female workers of childbearing age. A notation as “non-threshold reprotoxic substance” should therefore be introduced for lead and its inorganic compounds and employers should ensure that the occupational exposure of workers is reduced to as low a level as is technically possible.
Change 2
Changed:Recital 7 a (new): (7a) The Committee for Risk Assessment of the European Chemicals Agency has recommended an occupational exposure limit (OEL) of 4 μg Pb/m3 as an 8-hour time-weighted average (TWA)1a. The Committee also recommended a binding biological limit value (BLV) of 15 µg Pb/100ml (150 µg Pb/L), but concluded that such a BLV for lead does not protect the future children of female workers of childbearing age exposed. The Committee recommended that the blood-lead level in female workers of childbearing age should not exceed the reference values for the general population not occupationally exposed to lead in the relevant Member State. Where national reference levels are not available, blood-lead levels in women of childbearing age should not exceed the biological guidance value (BGV) of 4.5 μg/ml (45 μg/L), the maximal European reference value. The BGV relates to background exposure of the general population not occupationally exposed to lead. / 1a https://echa.europa.eu/documents/10162/ed7a37e4-1641-b147-aaac-fce4c3014037
Change 3
Removed:source: https://www.europarl.europa.eu/doceo/document/TA-9-2022-0068_EN.pdf
Added:Recital 7 c (new): (7c) This Directive respects the fundamental rights recognised in the Charter of Fundamental Rights of the European Union, in particular the prohibition of discrimination on the ground of sex and the right to fair and just working conditions provided for, respectively, in Articles 21 and 31 thereof. Moreover, it complies with Principle No 10 of the European Pillar of Social Rights, according to which workers have the right to a healthy, safe and well-adapted work environment. The right of workers to the protection of health and safety at work includes the right to protection from the effects of lead and its inorganic compounds on future generations, such as the negative impacts on the reproductive capacity of men and women, as well as on foetal development. Therefore, the Biological Guidance Value for female workers of childbearing age should be assessed by the Commission in a forthcoming revision and established as a binding BLV as close to the reference values of the general population not occupationally exposed to lead in accordance with Article 18a, paragraph 7b of Directive 2004/37/EC. Such a BLV is intended to foster the full participation of female workers of childbearing age in economic sectors targeted by the European Green Deal, such as the production of sustainable and circular batteries, in support of the Union’s energy transition.
Removed:Recital 7 c (new): (7c) This Directive respects the fundamental rights recognised in the Charter of Fundamental Rights of the European Union, in particular the prohibition of discrimination on the ground of sex and the right to fair and just working conditions provided for, respectively, in Articles 21 and 31 thereof. Moreover, it complies with Principle No 10 of the European Pillar of Social Rights, according to which workers have the right to a healthy, safe and well-adapted work environment. The right of workers to the protection of health and safety at work includes the right to protection from the effects of lead and its inorganic compounds on future generations, such as the negative impacts on the reproductive capacity of men and women, as well as on foetal development. Therefore, a revised BLV equal to 4.5 µg/100ml blood, accompanied by a revised OEL equal to 4 µg Pb/m3 TWA should be established, to ensure the protection of workers who are occupationally exposed to lead, irrespective of their sex. Such a revised BLV is also intended to foster the full participation of women of child-bearing age in economic sectors targeted by the European Green Deal, such as the production of sustainable and circular batteries, in support of the Union’s energy transition.
Added:Recital 8 a (new): (8a) Workers who have been occupationally exposed to lead over a number of years may have accumulated blood-lead levels well above the revised BLV. In the opinion of Committee for Risk Assessment, adverse health effects can already be observed at blood-lead levels that fall within the current BLV of 70 µg Pb/100ml. Employers should move such workers to other tasks in the workplace to ensure the fastest possible decrease in such workers’ blood-lead levels. If this is not possible, workers with blood-lead levels between 15-30 µg Pb/100ml could be allowed continue performing tasks that involves exposure to lead, provided that a decline in their blood-lead level can be established. Such workers should be subject to enhanced and continued medical surveillance to ensure a downward trend in their blood-lead level. The Commission should, after consulting the ACSH and the social partners, develop guidelines and recommendations concerning workers with historical exposure, as well as practical implementation by the Member States to ensure that their social safety net for such workers is covering them, for example adequate compensation, support and reskilling of workers who have been occupationally exposed to lead over a number of years.
Show 6 more lines
Removed:A non-binding guidance value is not suitable to ensure the protection of workers’ health and safety in conditions of equality and non-discrimination, with regard in particular to female lead-exposed workers. In order to attain the Directive’s stated objective of a high level of protection of worker’s health and safety, a binding BLV which offers sufficient protection for all workers irrespective of their sex, is necessary. It must be stressed that this Directive will apply to many economic sectors that possess a great potential for creating green jobs, but at the same time are currently male-dominated: applying the same protective measures to female and male lead-exposed workers will ensure that female workers enjoy equal treatment in matters of employment and occupation, and do not suffer from covert discrimination, for example with regard to access to employment.
Added:Recital 9: (9) Specific measures should be put in place with regard to risk management, including hygiene measures, the use of personal protective equipment and specific health surveillance that should take into consideration the circumstances of individual workers. Since lead is a non-threshold reprotoxic substance, preventive medical surveillance should be one of the most important protection measures for lead-exposed workers, in addition to technical preventive measures to be taken by the employer. Under the general requirements of Directive 2004/37/EC, employers are obliged to ensure the substitution of the substance when technically possible, the use of closed systems, or the reduction of exposure to as low as technically possible. In addition, as suggested in the opinion of the Advisory Committee on Safety and Health at Work90, the blood level of lead and its inorganic compounds in women of childbearing age should not exceed the reference values of the general population not occupationally exposed to lead and its inorganic compounds in the respective Member State. 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 Council91 , advised the use of a biological guidance value (BGV) as there was insufficient scientific evidence to set a BLV for women of childbearing age. When national reference levels are not available, blood levels of lead and its inorganic compounds in wome…
Removed:Recital 8: (8) Moreover, to strengthen the health surveillance of workers exposed to lead and its inorganic compounds and thus contribute to the prevention and protection measures to be undertaken by the employer, it is necessary to amend the existing requirements that apply when workers are exposed to certain levels of lead and its inorganic compounds. To that end, detailed medical surveillance should be required when exposure to lead and its inorganic compounds exceeds 2 µg/m3 in air (50% of current OEL) or 2.7 µg/100ml blood (approx. 60% of the current BLV).
Added:Recital 9 a (new): (9a) Some of the substances covered by this Directive, such as lead, are deemed necessary for the restoration of cultural heritage or certain cultural activities. For these substances and only when no suitable alternative exists, the Commission should assess the socio-economic benefits derived from the use of such substances against the risk posed to workers in these specific sectors or these activities. Based on this assessment and in consultation with the social partners, the Commission should consider targeted and limited exemptions for the cultural sector and heritage-related activities to existing OELs and BLVs.
Removed:Recital 8 a (new): (8a) Workers who have been occupationally exposed to lead over several years may have accumulated blood-lead levels well above the revised BLV. In the opinion of Committee for Risk Assessment, adverse health effects can already be observed at blood-lead levels that fall within the current BLV of 70 µg Pb/100ml. It is not acceptable that such workers continue to be exposed to lead in the workplace. Instead, employers should move such workers to other tasksin the workplace to ensure the fastest possible decrease in such workers’ blood-lead levels.
Added:Recital 9 b (new): (9b) Union-wide data from work-related health problems due to lead exposure are often lacking, unreliable or insufficient. The Commission should develop guidelines and recommendations for data collection by the Member States to improve the reporting and exposures registries.
Change 4
Changed:Recital 9: (9) Specific measures should be9 putc in(new): place(9c) withThere regardis toa riskneed management,for includingin-depth specificknowledge healthon surveillancethe thatlong-term shouldeffect takeof intolead considerationand theits circumstancesinorganic ofcompounds. individualMember workers.States Sinceauthorities leadshould isensure, ain non-thresholdparticular, reprotoxicthat substance,the preventivemeasures medicalon surveillancethe shouldprevention beand onereduction of the most important protectionexposure measures for lead-exposedworkers workers,set inout additionin toArticle technical5 preventiveof measuresDirective to2004/37/EC, beas takenwell byas the employer. Underinformation theand generaltraining requirements of Directive 2004/37/EC, employers are obliged toprovided ensurefor thein substitutionArticles of11 theand substance12 whenand technicallyhygiene possible,and theindividual useprotection ofmeasures closedset systems,out orin theArticle reduction10 of exposurethat toDirective astake lowinto asconsideration technicallythe possible.vulnerable /situation (deleted)of /women (deleted)in /childbearing (deleted)age.
26 more changes
Change 5
Removed:Recital 15 a (new): (15a) Following the adoption of the Commission Delegated Regulation (EU) 2023/7071a and the introduction of a new hazard class for endocrine disruptors, such substances should be covered by Union health and safety law. It is therefore necessary to consider extending the scope of Directive 2004/37/EC to endocrine disruptors, which have the ability to interfere with the hormonal system and can therefore induce adverse health effects. / 1a Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures (OJ L 93, 31.3.2023, p. 7)
Added:Recital 14: (14) The Commission has consulted the Committee for Risk Assessment) which provided opinions on both substances. The Commission has carried out a two-stage consultation of management and labour at Union level in accordance with Article 154 of the Treaty. It has also consulted the Advisory Committee on Safety and Health at Work, which adopted opinions regarding the revision of the limit values for lead and its inorganic compounds93 and establishment of an occupational limit value for diisocyanates94, with recommendations for appropriate notations, and a review of the limit values for diisocyanates starting in 2029. Therefore, the Commission should launch the process of evaluating the need to modify the binding limit values for diisocyanates and should, after consulting the ACSH, where appropriate, propose necessary amendments to that group of substances, and taking into account the number of cases on occupational asthma reported by the Member States to the Commission.
Removed:In its INI report on a new EU strategic framework on health and safety at work post 2020 (including better protection of workers from exposure to harmful substances, stress at work and repetitive motion injuries) of 9 February 2022, the European Parliament stresses that workers should be protected against exposure to endocrine disruptors by EU legislation. Source: https://www.europarl.europa.eu/doceo/document/TA-9-2022-0068_EN.pdf
Added:Recital 14 a (new): (14a) Cobalt and cobalt compounds meet the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and are therefore carcinogens within the meaning of Directive 2004/37/EC. Exposure to cobalt and cobalt compounds at workplaces may result in dermal sensitisation and the sensitisation of the respiratory tract. It is therefore appropriate, on the basis of the available information, including scientific and technical data, to establish limit values urgently for both the inhalable and respirable fractions of cobalt and of cobalt compounds in Directive 2004/37/EC.
Show 20 more lines
Removed:Recital 15 b (new): (15b) 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.
Added:Recital 14 b (new): (14b) Benzene meets the criteria for classification as carcinogenic (category 1A) in accordance with Regulation (EC) No 1272/2008 and is therefore a carcinogen within the meaning of Directive 2004/37/EC. Benzene can also be absorbed through the skin. By 1 January 2030, the limit value for benzene set out in Annex III to Directive 2004/37/EC should be revised in light of more recent scientific data, after consulting the ACSH. It is appropriate to keep the skin notation. Following the opinion of RAC, the ACSH also agreed about the usefulness of the biomonitoring for benzene. Those matters should be taken into account when developing guidance on the practical use of biomonitoring.
Removed:This amendment was put forward in the European Parliament report on the proposal for a directive of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work of 7 April 2021 (CMD4). Source: https://www.europarl.europa.eu/doceo/document/A-9-2021-0114_EN.pdf
Added:Recital 15 a (new): (15a) The Occupational Exposure Limit Value and the Biological Limit Values, including the limit value for historical exposure and the guidance value for female workers of childbearing age on lead, should be kept under regular scrutiny and strictly reviewed at least every five years, after the entry into force of this directive. Such a review should be done on the basis of advances in knowledge and technologies and up-to-date scientific data, in order to address the negative impacts on the reproductive capacity of female workers of childbearing age as well as on foetal development and to ensure equal protection for all workers regardless of their gender. Such a review should also take into account the classification of lead as a non-threshold reprotoxic.
Removed:Recital 15 c (new): (15c) The World Health Organization classified the occupational exposure of firefighter as carcinogenic to humans (Group 1). Occupational exposure as a firefighter includes a variety of hazards resulting from fires and non-fire events. Firefighters can be exposed to combustion products from fires, building materials, chemicals in firefighting foams, flame retardants and diesel exhaust. The uptake of fire effluents or other chemicals can occur via inhalation and dermal absorption and possibly via ingestion. Such workers should therefore be better protected from such exposure.
Added:Recital 15 b (new): (15b) After the introduction of the amendments to Annex III to Directive 2004/37/EC provided for in this Directive, further limit values for additional substances or groups of substances and processes should be introduced by the end of 2024. Between 50 and 70 substances or groups of substances have been identified by different agencies, stakeholders, and the World Health Organization in priority lists of workplace carcinogens, mutagens and reprotoxic substances for which binding limit values are needed. The Commission should, no later than [one year after the entry into force of this Directive], update its action plan to achieve occupational exposure limits for at least 5 additional substances or groups of substances or process-generated substances. The additional substances or groups of substances referred to in Annex III to Directive 2004/37/EC should include but not be limited to substances and processes such as lithium and lithium compounds, methyl hydrazine, 1,3-propanesultone, welding fumes and leather dust.
Removed:source: https://monographs.iarc.who.int/list-of-classifications
Added:Recital 15 c (new): (15c) Substances and mixtures with endocrine disrupting properties pose a concern to public health. It has been proven that endocrine disruption can lead to certain disorders in humans, such as birth defects, developmental, reproductive or neurodevelopmental disorders, cancer, diabetes and obesity. The Commission communication of 14 October 2020 entitled ‘Chemicals strategy for sustainability. Towards a toxic-free environment’ highlighted the need to establish a legally binding hazard identification of endocrine disruptors and to protect workers from those substances. Following the adoption of the Commission Delegated Regulation (EU) 2023/7071a and the introduction of a new hazard class for endocrine disruptors, such substances should be covered by Union health and safety law. It is therefore necessary to consider extending the scope of Directive 2004/37/EC to endocrine disruptors, which have the ability to interfere with the hormonal system and can therefore induce adverse health effects. / 1a Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures (OJ L 93, 31.3.2023, p. 7).
Removed:Recital 15 d (new): (15d) Union action, such as the European Green Deal launched in the Commission communication of 11 December 2019 and the Critical Raw Material initiative launched in the Commission communication 16 March 2023, entitled ‘A secure and sustainable supply of critical raw materials in support of the twin transition’, promote sustainable development, which requires a balance between environmental, economic, and social considerations. By enacting binding occupational exposure limits of carcinogens, mutagens and reprotoxic substances, workers are better protected from harm and can continue to work as safely as possible in industries that produce critical raw materials or contribute to the green economy. This, in turn, promotes a just green and digital transition by ensuring that workers’ health are not compromised at the expense of the Union’s economic and environmental goals. Protecting workers from exposure to hazardous substances also contributes to the objectives of Europe’s Beating Cancer Plan, set out in the Commission communication of 3 February 2021.
Added:Recital 15 d (new): (15d) 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.
Removed:Recital 15 e (new): (15e) Due to unpredictable exposure to certain substances, a mix of substances or constraints in the organisation of work, some occupations should be considered to be carcinogenic per se. It is difficult in some occupations to predict and prepare for the extent to which workers will be exposed to substances or mixes of substances. It is to be expected that the World Health Organization’s list of carcinogenic hazards will be expanded in accordance with the increasing amount of data and the progress of medical and scientific research, which highlight the carcinogenic nature of some occupations. Therefore, a non-exhaustive Union list of occupations that are considered to be carcinogenic would help employers identify recognised professions at risk and would facilitate the implementation of adequate protective measures and training pursuant to Directives 98/24/EC and 2004/37/EC. While the protective measures under Directives 98/24/EC and 2004/37/EC should not be exclusive to occupations on that list, it would provide employers with guidance.
Added:Recital 15 e (new): (15e) The World Health Organization has classified the occupational exposure of firefighters as carcinogenic (Group 1). Occupational exposure of firefighters includes a variety of hazards resulting from fires and non-fire events. Firefighters can be exposed to combustion products from fires, building materials, chemicals in firefighting foams, flame retardants and diesel exhaust. The uptake of fire effluents or other chemicals can occur by inhalation and dermal absorption and possibly via ingestion. Such workers should therefore be better protected from such exposure.
Removed:Recital 15 f (new): (15f) The circular economy and the waste collecting, sorting and recovery sectors are growing fast to meet the objectives of the European Green Deal, to ensure the sustainability of European industry and to ensure greater strategic autonomy to the Union. However, those positive developments raise many occupational health and safety issues for workers in that industry, who, by the very nature of their activity, are likely to be disproportionately exposed to harmful substances. Exposure to lead, mercury and other hazardous metals in waste recycling facilities is for example already a reality for many such workers. Ambitious protective measures, adequate prevention policies, as well as good quality working conditions are necessary to reduce the risks of exposure to hazardous substances and to ensure a high level of protection.
Added:Recital 15 f (new): (15f) Union action, such as the European Green Deal launched in the Commission communication of 11 December 2019 and the Critical Raw Material initiative launched in the Commission communication of 16 March 2023, entitled ‘A secure and sustainable supply of critical raw materials in support of the twin transition’, promote sustainable development, such as for example the batteries sector which is one of the several sectors of strategic importance to reach the objectives of Regulation (EU) 2021/1119. This requires a balance between environmental, economic, and social considerations. By enacting binding occupational exposure limits of carcinogens, mutagens and reprotoxic substances, workers are better protected from harm and can continue to work as safely as possible in industries that produce critical raw materials, such as lead, stimulating the circular economy and maintaining and enhancing the international strategic autonomy in raw materials, which are all priorities of the Union. Protecting workers from exposure to hazardous substances also contributes to the objectives of "Europe’s Beating Cancer Plan", set out in the Commission communication of 3 February 2021. This promotes a just, green and digital transition in which workers’ health and a high level of protection go hand in hand with the Union’s economic and environmental goals. Because of the harmful properties of lead and its inorganic compounds, relocation of lead-processing companies to third countries with less s…
Removed:Recital 15 g (new): (15g) The informal sector is proportionally over-represented in the waste collecting, sorting and recovery sectors. A high exposure to risks, including harmful substances, combined with a low level of social protection place most informal economy workers in a very vulnerable situation. Preventive measures, in the form of occupational health and safety management systems and a general safety culture, to reduce risks at work often do not reach the informal economy. Special attention should be paid to those precarious workers in order to offer safe working conditions and environments as well as equal treatment with workers in the same sector or in sectors that are better regulated.
Added:Recital 15 g (new): (15g) Due to unpredictable exposure to certain substances, a mix of substances or constraints in the organisation of work, some occupations should be considered to be carcinogenic per se. For some occupations it is difficult to predict and prepare for the extent to which workers will be exposed to substances or mixes of substances. It is to be expected that the World Health Organization’s list of carcinogenic hazards will be expanded in accordance with the increasing amount of data and the progress of medical and scientific research, which highlight the carcinogenic nature of some occupations. Therefore, the Commission should develop a definition of carcinogenic occupations with the purpose of supporting employers in identifying at-risk professions, and to facilitate the implementation of adequate protective measures and training pursuant to Directives 98/24/EC and 2004/37/EC.
Added:Recital 15 h (new): (15h) The circular economy and the waste collecting, sorting and recovery sectors are growing fast to meet the objectives of the European Green Deal, in order to ensure the sustainability of European industry and to ensure greater strategic autonomy to the Union. However, those positive developments raise many occupational health and safety issues for workers in that industry, who, by the very nature of their activity, are likely to be disproportionately exposed to harmful substances. Exposure to lead, mercury and other hazardous metals in waste recycling facilities is for example already a reality for many such workers. Ambitious protective measures, adequate prevention policies, as well as good quality working conditions are necessary to reduce the risks of exposure to hazardous substances and to ensure a high level of protection.
Added:Recital 15 i (new): (15i) Informal workers are present in the waste collecting, sorting and recovery sectors. A high exposure to risks, including harmful substances, combined with a low level of social protection place most informal economy workers in a very vulnerable situation. Preventive measures, in the form of occupational health and safety management systems and a general safety culture, to reduce risks at work often do not reach the informal economy. The protective measures of this Directive should apply equally to all workers. To this end, full enforcement of this Directive, including by way of labour inspections, is necessary in order to ensure safe working conditions and environments as well as equal treatment of workers across sectors.
Added:Directive 98/24/EC
Added:Article 1 – paragraph 1 – point -1 (new), Article 12 – paragraph 2 a (new): (-1) in Article 12, the following paragraph is added: / ‘2a. No later than 31 December 2029, the Commission shall launch a revision process for the occupational exposure limit and the short-term occupational exposure limit values for diisocyanates, taking especially into account the evaluation of the REACH Regulation and any relevant data available and shall, where appropriate, submit necessary amendments to the group of substances set out in Annex I without delay.’;
Change 6
Changed:Article 2 – paragraph -11 – point 1 (new), Article 2 –point– point b: (1) in Article 2(1), point (b) is replaced by the following: / "(b) ‘mutagen’ means: / (i) a substance or mixture which meets the criteria for classification as a category 1A or 1B germ cell mutagen 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;"Annex; "
Change 7
Removed:Annex I concerns all hazardous substances covered in this directive, including ‘mutagens’.
Change 8
Changed:Article 2 – paragraph -11 – point 2 (new), Article 2 –point– point ba: (2) in Article 2(1), point (ba) is replaced by the following: / "(ba) ‘reprotoxic substance’ means: / (i) a substance or mixture, which meets the criteria for classification as a category 1A or 1B reproductive toxicant set out in Annex I to Regulation (EC) No 1272/2008; / (ii) a substance, mixture or process referred to in Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex;"Annex; "
Change 9
Removed:Annex I concerns all hazardous substances covered in this directive, including ‘reprotoxic substances’
Change 10
Changed:Article 2 – paragraph -11 – point 3 (new), Article 2 ––– point e a (new): (3) in Article 2(1), the following point is added: / “(ea) 'hazardous medicinal products’ or HMP’‘HMP’ means medicinal products that contain one or more substances that meet the criteria for classification as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B) or toxic for reproduction (category 1A or 1B) in accordance with Regulation (EC) No 1272/2008.”1272/2008.”;
Change 11
Removed:This definition is used the European Commission “Guidance for the safe management of hazardous medicinal products at work. Source: https://ec.europa.eu/social/main.jsp?langId=en&catId=89&furtherNews=yes&newsId=10564&pk_source=newsletter&pk_medium=email&pk_campaign=eu_social_newsletter
Change 12
Changed:Article 2 – paragraph -11 – point 4 (new), Article 5 – paragraph 4 a (new):4: (4) in Article 5, the following paragraph 4a4 is inserted: / “4a.replaced Inby the case of exposure tofollowing: a/ combination“4. ofExposure substancesshall actingnot byexceed the samelimit modevalue of action or at the samea targetcarcinogen, cellmutagen or tissue,a thereprotoxic implementationsubstance ofas theset possibleout limitin valuesAnnex ofIII. thoseBiological substanceslevels shall be adaptednot toexceed takethe intobiological accountlimit thevalue combinedfor effectsa incarcinogen, accordancemutagen withor Uniona guidelinesreprotoxic tosubstance beas developedset pursuantout toin ArticleAnnex 18a.”IIIa.”
Change 13
Removed:This amendment was put forward in the European Parliament report on the proposal for a directive of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work of 7 April 2021 (CMD4). Source: https://www.europarl.europa.eu/doceo/document/A-9-2021-0114_EN.pdf
Change 14
Changed:Article 2 – paragraph - 1 – point 5 (new), Article 5 – paragraph 54 a (new): (5) in Article 5, the following paragraph is added: / “5a.“4a. BiologicalIn levelsthe shallcase notof exceedexposure to a combination of substances acting by the biologicalsame limitmode valueof foraction aor carcinogen,at mutagenthe same target cell or atissue, reprotoxicthe substanceimplementation setof outthe possible limit values of those substances shall be adapted to take into account the combined effects of such substances in Annexaccordance IIIa.”with Union guidelines, pursuant to Article 18a, paragraph 7a.”;
Change 15
Changed:Article 2 – paragraph -11 – point 6 (new), Article 18a – paragraph 7 a (new):7: (6) in Article 18a, the following paragraph is added: / “By ...7 [oneis yearreplaced afterby the date offollowing: entry/ into“No forcelater ofthan this31 amendingDecember Directive],2023, the Commission shall, taking into account the latest developments in scientific knowledge and the opinionafter ofconsulting the Committee forACSH, Risktaking Assessmentinto ofaccount the European Chemicals Agency established by Regulation (EC)RAC’s No2018 1907/2006,opinion and after appropriate consultation of relevant stakeholders, prepare Union guidelines on how the implementation of the limit values referred to in Article 5(4) and 5(4b) are to belatest adapteddevelopments in thescientific caseknowledge, ofwhere exposureappropriate, tosubmit a combination of substances. Thoselegislative guidelinesproposal shallto beintroduce publisheda onlimit thevalue EU-OSHAfor websitecobalt and shall be disseminated in all Member States by the relevantinorganic competentcobalt authorities.”compounds.”;
Change 16
Removed:This amendment was put forward in the European Parliament report on the proposal for a directive of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work of 7 April 2021 (CMD4). Source: https://www.europarl.europa.eu/doceo/document/A-9-2021-0114_EN.pdf
Change 17
Changed:Article 2 – paragraph -11 – point 7 (new), Article 18a – paragraph 7 ba (new): (7) in Article 18a, the following paragraph is added: / “By ... [x[one monthsyear after the date of entry into force of this amending directive],Directive], the Commission shallshall, reviewtaking into account the implementationlatest developments in scientific knowledge and the opinion of thisthe Directive.Committee Infor Risk Assessment of the contextEuropean Chemicals Agency established by Regulation (EC) No 1907/2006, and after appropriate consultation of thatrelevant review,stakeholders, itsprepare shallUnion considerguidelines whetheron furtherhow amendmentsthe implementation of the limit values referred to thisin DirectiveArticle 5(4a) are appropriate,to shallbe assessadapted in the feasibilitycase of includingexposure endocrineto disruptersa withincombination theof scopesubstances. ofThose thisguidelines Directiveshall and,be wherepublished appropriate,on the EU-OSHA website and shall presentbe adisseminated legislativein proposal.”all Member States by the relevant competent authorities.”;
Change 18
Changed:Article 2 – paragraph -11 – point 8 (new), Article 18a – paragraphpoint 7 cb (new): (8) in Article 18a, the following paragraph is added: / “By ... [twelve[12 months after the date of entry into force of this amending Directive],directive], the Commission shall,shall afterreview consultingthe implementation of this Directive. In the ACSH,context developof athat definitionreview, it shall consider whether further amendments to this Directive are appropriate, shall assess the feasibility of ‘carcinogenicincluding occupations’.endocrine Adisrupters non-exhaustivewithin listthe scope of suchthis occupationsDirective shalland beshall, annexedwhere appropriate, submit to thisthe Directive.”European Parliament and to the Council a legislative proposal.”;
Change 19
Changed:Article 2 – paragraph -11 – point 9 (new), Article 18a – paragraph 7 dc (new): (9) in Article 18a, the following paragraph is added: / “By ...‘By... [twelve[five monthsyears after the date of entry into force of this amending Directive],directive] theand Commissionevery shall,five afteryears consultingthereafter, the ACSH,Commission developshall guidelinesreview asthe regardsOccupational historicalExposure occupationalLimit exposureValue toand lead,the inBiological particularLimit Values including the protectionlimit andvalue reductionfor ofhistorical exposure and the guidance value for female workers whoseof blood-levelchildbearing levelsage, arelaid abovedown thein biologicalAnnex limitIII value.and ThoseIIIa, guidelinestaking shallinto beaccount publishedthe negative impacts on the EU-OSHAreproductive websitecapacity andof shallfemale beworkers disseminatedof childbearing age as well as on foetal development in order to ensure equal protection for all Memberworkers Statesregardless byof their gender as well as taking into account up-to-date scientific data and the relevantclassification competentof authorities.”lead as a non-threshold reprotoxic.’
Change 20
Added:Directive 2004/37/EC
Added:Article 2 – paragraph 1 – point 10 (new), Article 18a – paragraph 7 d (new): (10) in Article 18a, the following paragraph is added: / “By ... [twelve months after the date of entry into force of this amending Directive], the Commission shall, after consulting the Advisory Committee for Safety and Health at Work (ACSH), develop a definition of ‘carcinogenic occupations’ and assess the appropriateness to include such occupations in the scope of this Directive.”;
Added:Directive 2004/37/EC
Added:Article 2 – paragraph 1 – point 11 (new), Article 18a – paragraph 7 e (new): (11) in Article 18a, the following paragraph is added: / “By ... [twelve months after the date of entry into force of this amending Directive], the Commission shall, after consulting the ACSH, develop guidelines as regards historical occupational exposure to lead with a view to increasing the protection and reduction of the exposure of workers whose blood-lead levels are above the biological limit value as well as to further protect female workers of childbearing age. Those guidelines shall be published on the EU-OSHA website and shall be disseminated in all Member States by the relevant competent authorities.”
Show 6 more lines
Added:Directive 2004/37/EC
Added:Article 2 – paragraph 1 – point 12 (new), Article 18a – paragraph 7 f (new): (12) in Article 18a, the following paragraph is added: / “By [one year after the entry into force of this Directive], the Commission shall, after consulting the ACSH and taking into account existing recommendations made by relevant agencies, stakeholders and the World Health Organization with regard to priority carcinogens, mutagens and reprotoxic substances for which limit values are needed, revise its action plan to achieve occupational exposure limits values for substances, or groups of substances or process-generated substances additional to those referred to in this Directive. This shall in particular include lithium and lithium compounds, methyl hydrazine, 1,3-propanesultone, welding fumes and leather dust. By [two years after the entry into force of this Directive], the Commission shall, taking into account that revised action plan to achieve limit values for additional substances or group of substances or process-generated substances, the latest developments in scientific knowledge, and after consulting the ACSH, submit to the European Parliament and the Council, where appropriate, a legislative proposal.”;
Added:Directive 2004/37/EC
Added:Article 2 – paragraph 1 – point 13 (new), Article 18a – paragraph 7 g (new): (13) in Article 18a, the following paragraph is added: / “By ... [twelve months after the date of entry into force of this amending Directive], the Commission shall, in consultation with social partners, consider targeted and limited exemptions for cultural and heritage-related work activities to existing Occupational Exposure Limit Values and Biological Limit Values, and take appropriate action.”
Added:Directive 2004/37/EC
Added:Article 2 – paragraph 1 – point 14 (new), Article 18a – paragraph 7 h (new): (14) in Article 18a, the following paragraph is added: / “By 1 January 2028, the Commission shall, taking into account the RAC’s 2018 opinion and the latest developments in scientific knowledge, assess the feasibility of a further reduction of the limit value for benzene and shall, by 1 January 2030, where appropriate, submit to the European Parliament and the Council the necessary legislative amendments to this Directive.”;
Change 21
Removed:Annex I concerns all hazardous substances covered in this directive, including ‘mutagens’ and ‘reprotoxic substances’
Change 22
Changed:Annex II – point -1 a (new), Annex I – title: (-1) in Annex I, the title is amended as follows: / "List of substances, preparations and processes / (Article 2(a)(ii), 2(b)(ii), 2(ba)(ii))”2(ba)(ii))”;
Change 23
Removed:Annex I concerns all hazardous substances covered in this directive, including ‘mutagens’ and ‘reprotoxic substances’
Change 24
Changed:Annex II – point -1 a (new), Annex I – point 8 a (new): (-1a) in Annex I, the following point is added: / “8 a.“8a. Work involving exposure to hazardous medicinal products.”products.”;
Change 25
Changed:Annex II – point 2, Annex IIIa: 4.5 μgLead Pb/100and mlits bloodinorganic (1)compounds / MedicalIf surveillancethe isresults carriedof outthe ifmedical exposuresurveillance toreveal a concentration ofblood-lead leadlevel inof aira isworker greater than 0,00230 mg/m3,μg calculatedPb/100 asml ablood, time-weightedthe averageemployer overand 40the hoursauthority perresponsible week,for orthe ahealth blood-leadsurveillance levelof greaterthat thanworker 2.7shall μgensure Pb/100that mlthe bloodworker is measuredno longer exposed to lead in individualaccordance workers.with the guidelines developed pursuant to Article 18a. / If the results of the medical surveillance reveal a blood-lead level of a worker greaterbetween than15-30 theμg biologicalPb/100 ml blood and if a declining trend towards the limit value duein toforce historicalis occupationalestablished, then that worker may continue working with tasks that involve exposure to lead,lead. the/ employerSpecific measures, shall be put in place with regard to risk management, including specific and theregular authorityhealth responsiblesurveillance, high standards for thepersonal healthprotective surveillanceequipment ofand thatregular workerblood-lead shallchecks. takeUnder the necessarygeneral measuresrequirement of Directive 2004/37/EC, employers are obliged to ensure athe decreasesubstitution of the worker’ssubstances blood-leadwhen technically possible, the use of closed systems, or the reduction of exposure to as low as technically possible. / Medical surveillance is carried out regularly for all workers exposed to lead and its inorganic compounds. / (1) It is recommended that the blood lead level in accordancefemale withworkers of childbearing age does not exceed the guidelinesreference developedvalues pusuantof the general population not occupationally exposed to Articlelead 18a.in /the (deleted)respective EU Member State. When national reference levels are not available, it is recommended that blood lead leve…
Change 26 under “EXPLANATORY STATEMENT”
Added:With this report, the European Parliament is adopting for the first time occupational limit values for diisocyanates, which is a substance essential to the green transition, while revising the limit values for lead for the first time in more than 40 years. A review mechanism is also introduced to guarantee regular revisions from now on to make sure that those limit values will be regularly updated, taking into account the latest scientific data.
Change 27 under “EXPLANATORY STATEMENT”
Changed:The limit values (occupational exposure limit / short term exposure limit) for diisocyanates, which are now proposed for the first time at EU level, are supported by the Advisory Committee on Safety and Health at Work (ACSH), consisting of national governments and workers’ and employers’ organisations. This report therefore proposes to adopt thesethe limit values unamendedand the revision clause proposed by the ACSH unamended, in the spirit of supporting and advancing solutions that have been agreed between the social partners, jointly with the national administrations.
Change 28 under “EXPLANATORY STATEMENT”
Removed:In the absence of a consensus in the ACSH on the limit values for lead, this report considers it necessary to amend the Commission proposal on a number of points, especially the BLV as regards women of childbearing age.
Added:In the absence of a consensus in the ACSH on the limit values for lead, this report supports the Commission proposal to lower the OEL from 0.15 milligrams per cubic meter (0.15mg/m3) to 0.03mg/m3 and to lower the BLV from 70 microgram per 100 millilitre of blood (70µg/100ml) to 15µg/100ml. Additionally, this report proposes a revision clause which addresses the negative impact of occupational exposure to lead on the reproductive health of female workers of childbearing age, as well as on foetal development. The revision clause should also take into account up-to-date scientific data and the classification of lead as a non-threshold reprotoxic.
Removed:Women of childbearing age and non-discrimination
Removed:Following an opinion of The Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA), the Commission has proposed to lower the BLV to 15µg Pb/100ml. However, RAC also concluded that “the BLV is not protective for the offspring of female lead-exposed workers at childbearing age”. RAC recommended that the blood-lead level in women of childbearing age should not exceed the reference values of the general population not occupationally exposed to lead in the respective EU country - and where national reference levels are not available, blood-lead levels in women of childbearing age should not exceed 4.5μg Pb/100ml, which is the maximal European reference value.
Show 4 more lines
Removed:On that background the Commission has proposed to accompany the binding BLV with a non-binding Biological Guidance Value of 4.5μg Pb/100ml for women of childbearing age. While Directive 92/85/EEC provides for the protection of the health and safety of pregnant workers in the work place, its protective measures do not apply until such workers inform their employer of their condition.
Removed:In the Vind INI report, on a new EU strategic framework on health and safety at work post 2020 (including better protection of workers from exposure to harmful substances,
Removed:stress at work and repetitive motion injuries) of 9 February 2022, the European Parliament noted that the RAC recommendation of a BLV of 15µg Pb/100ml does not protect women and especially pregnant women properly. It called on the Commission to ensure that any proposal for revised exposure limit values for lead and its compounds should establish equal protection for all workers regardless of gender.
Removed:This report is of the opinion that a non-binding guidance value is not suitable to ensure the protection of workers’ health and safety in conditions of equality and non-discrimination, with regard in particular to female lead-exposed workers. In order to attain the Directive’s stated objective of a high level of protection of worker’s health and safety, a binding biological limit value, which offers sufficient protection for both female and male workers, is necessary.
Change 29 under “EXPLANATORY STATEMENT”
Changed:This report takes into account the specific situation of workers with historical exposure. Workers who have been occupationally exposed to lead over several years may already have accumulated blood-lead levels well above any new BLV. In such situations, it is not acceptable that such workers continue to be exposed and all necessary measures must be taken to ensure that the blood-levels of such workers decrease as fast as possible.
Change 30 under “EXPLANATORY STATEMENT”
Added:if the results of the medical surveillance reveal a blood-lead level of a worker between 15-30 μg Pb/100 ml blood and if a declining trend towards the limit value in force is established, then that worker may continue working with tasks that involve exposure to lead. Otherwise, the responsible authority shall ensure that the worker is no longer exposed to lead. Additionally, this report calls on the Commission to develop guidelines, in consultation with the ACSH, as regards historical occupational exposure to lead with a view to increasing the protection and reduction of the exposure of workers whose blood-lead levels are above the biological limit value as well as to further protect female workers of childbearing age.
Added:Combined exposure
Added:In order 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. This report calls on the Commission to prepare Union guidelines on how the implementation of those limit values are to be adapted in the case of exposure to a combination of substances.
Added:Definition of carcinogenic occupations
Show 5 more lines
Added:Due to unpredictable exposure to certain substances, a mix of substances or constraints in the organisation of work, some occupations should be considered to be carcinogenic per se. This report calls on the Commission to develop a definition of ‘carcinogenic occupations’ and assess the appropriateness to include such occupations in the scope of the CMRD Directive.
Added:Endocrine disruptors and additional substances
Added:This reports invites the Commission to extend the scope of the CMRD directive to endocrine disruptors that can lead to certain disorders in humans, such as birth defects, developmental, reproductive or neurodevelopmental disorders, cancer, diabetes and obesity. This report is also calling on adding new substances in the framework of the CMRD directive, such as lithium welding fumes and leather dust as well as to establish a limit value for cobalt and inorganic cobalt compounds.
Added:Informal work
Added:A high exposure to risks, including harmful substances, combined with a low level of social protection place most informal economy workers in a very vulnerable situation. Preventive measures, in the form of occupational health and safety management systems and a general safety culture, to reduce risks at work often do not reach the informal economy. This report calls on the full enforcement of the CMRD and CAD directives in order to ensure safe working conditions and environments as well as equal treatment of workers across sectors.