35 Amendments of Aurore LALUCQ related to 2023/0033(COD)
Amendment 44 #
Proposal for a directive
Recital 6
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 exposures to reprotoxic substances.
Amendment 50 #
Proposal for a directive
Recital 7
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. Therefore, a revised biological limit value equal to 15 µg/100ml blood, accompanied by a revised occupational exposure limit value equal to 0.03 mg/m3 as an 8-hour time-weighted average (TWA) should be established.
Amendment 54 #
Proposal for a directive
Recital 7 a (new)
Recital 7 a (new)
Amendment 58 #
Proposal for a directive
Recital 7 b (new)
Recital 7 b (new)
(7b) In its initiative report on a new Union 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 noted that a BLV of 15 µg Pb/100ml (150 µg Pb/L) “does not protect women and especially pregnant women properly” and called for revised exposure limit values for lead and its compounds while ensuring equal protection for all workers regardless of gender.
Amendment 61 #
Proposal for a directive
Recital 7 c (new)
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.
Amendment 66 #
Proposal for a directive
Recital 8
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 0.015 m2 µg/m3 in air (50% of current OEL) or 92.7 µg/100ml blood (approx. 60% of the current BLV).
Amendment 71 #
Proposal for a directive
Recital 8 a (new)
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 tasks in the workplace to ensure the fastest possible decrease in such workers’ blood- lead levels.
Amendment 72 #
Proposal for a directive
Recital 9
Recital 9
(9) Specific measures should be put in place with regard to risk management, including specific health surveillance that should take into consideration the circumstances of individual workers. 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 women of childbearing age should not exceed the BGV of 4.5 µg/100ml, as recommended by the opinion of the RAC92 . The BGV is an indicator of exposure but not of identifiable adverse health effects. Therefore, it acts as a sentinel marker to alert employers on the need to pay specific attention to this specific potential risk and to introduce measures to ensure that any exposure to lead and its inorganic compounds does not result in adverse developmental health effects in the foetus or offspring of female workers. __________________ 90 ACSH opinion on lead (2021). https://circabc.europa.eu/ui/group/cb9293 be-4563-4f19-89cf- 4c4588bd6541/library/60b206e1-ee10- 40c2-9540-fb6510c11a0c/details 91 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.) 92 On the evaluation of the occupational exposure limits for lead and its compounds, delivered on 11 June 2020. (See section 8.2.4. of the annex to the opinion). https://echa.europa.eu/documents/10162/e d7a37e4-1641-b147-aaac-fce4c3014037Since 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.
Amendment 84 #
Proposal for a directive
Recital 12
Recital 12
(12) Diisocyanates can be absorbed through the skin and exposure to diisocyanates at the place of work may also result in dermal sensitisation and sensitisation of the respiratory tract. It is therefore appropriate to establish an occupational exposure limit of 6 µg NCO/m³ and a short-term exposure limit of 12 µg NCO/m³ for this group of chemical agents and to assign a skin, dermal and respiratory sensitisation notation to it.
Amendment 87 #
Proposal for a directive
Recital 13
Recital 13
(13) It may be difficult to comply with an occupational exposure limit equal to 6 µg NCO/m³ for diisocyanates, accompanied by an associated short-term exposure limit equal to 12 µg NCO/m³. This difficulty is due to technical measurement feasibility issues and the time needed to implement risk management measures in particular in downstream sectors involving activities such as applications of paints, work with lead metal, demolition, repair and scrap management, other waste management and soil remediation. Therefore, a transitional value of 10 µg NCO/m³ with an associated short- term exposure limit equal to 20 µg NCO/m³ should apply until 31 December 2028.
Amendment 95 #
Proposal for a directive
Recital 15 a (new)
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)
Amendment 101 #
Proposal for a directive
Recital 15 b (new)
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.
Amendment 103 #
Proposal for a directive
Recital 15 c (new)
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.
Amendment 107 #
Proposal for a directive
Recital 15 d (new)
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 2021.1 __________________ 1 https://health.ec.europa.eu/system/files/20 22-02/eu_cancer-plan_en_0.pdf
Amendment 108 #
Proposal for a directive
Recital 15 e (new)
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.
Amendment 111 #
Proposal for a directive
Recital 15 f (new)
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.
Amendment 112 #
Proposal for a directive
Recital 15 g (new)
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.
Amendment 114 #
Proposal for a directive
Recital 15 h (new)
Recital 15 h (new)
(15h) Following the amendments to Annex III to Directive 2004/37/EC, as set out in this Directive, further limit values for additional substances or group of substances and processes should be introduced by the end of 2024. Between 50 and 70 substances or group 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 the end of 2023, update its action plan to achieve occupational exposure limits for at least 5 additional substances or group of substances or process generated substances.] The additional substances or group 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.
Amendment 124 #
Proposal for a directive
Article 2 – paragraph 1 – introductory wording (new)
Article 2 – paragraph 1 – introductory wording (new)
Directive 2004/37/EC is amended as follows:
Amendment 125 #
Proposal for a directive
Article 2 – paragraph 1 a (new)
Article 2 – paragraph 1 a (new)
(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; "
Amendment 128 #
Proposal for a directive
Article 2 – paragraph 1 b (new)
Article 2 – paragraph 1 b (new)
Directive 2004/37/EC
Article 2 – point b a
Article 2 – point b a
(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; "
Amendment 132 #
Proposal for a directive
Article 2 – paragraph -1 – point 3 (new)
Article 2 – paragraph -1 – point 3 (new)
Directive 2004/37/EC
Article 2 –– point e a (new)
Article 2 –– point e a (new)
(3) in Article 2(1), the following point is added: “(ea) 'hazardous medicinal products’ or 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.”
Amendment 135 #
Proposal for a directive
Article 2 – paragraph -1 – point 4 (new)
Article 2 – paragraph -1 – point 4 (new)
Directive 2004/37/EC
Article 5 – paragraph 4 a (new)
Article 5 – paragraph 4 a (new)
(4) in Article 5, the following paragraph 4a is inserted: “4a. 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, the implementation of the possible limit values of those substances shall be adapted to take into account the combined effects in accordance with Union guidelines to be developed pursuant to Article 18a.”
Amendment 140 #
Proposal for a directive
Article 2 – paragraph 1 e (new)
Article 2 – paragraph 1 e (new)
Directive 2004/37/EC
Article 5 – paragraph 5 a (new)
Article 5 – paragraph 5 a (new)
(5) in Article 5, the following paragraph is added: “5a. Biological levels shall not exceed the biological limit value for a carcinogen, mutagen or a reprotoxic substance set out in Annex IIIa.”
Amendment 151 #
Proposal for a directive
Article 2 – paragraph -1 – point 6 (new)
Article 2 – paragraph -1 – point 6 (new)
Directive 2004/37/EC
Article 18 a – paragraph 7 a (new)
Article 18 a – paragraph 7 a (new)
(6) in Article 18a, the following paragraph is added: “By ... [one year after the date of entry into force of this amending Directive], the Commission shall, taking into account the latest developments in scientific knowledge and the opinion of the Committee for Risk Assessment of the European Chemicals Agency established by Regulation (EC) No 1907/2006, 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 be adapted in the case of exposure to a combination of substances. Those guidelines shall be published on the EU- OSHA website and shall be disseminated in all Member States by the relevant competent authorities.”
Amendment 152 #
Proposal for a directive
Article 2 – paragraph 1 g (new)
Article 2 – paragraph 1 g (new)
Directive 2004/37/EC
Article 18 a – paragraph 7 b (new)
Article 18 a – paragraph 7 b (new)
(7) in Article 18a, the following paragraph is added: “By ... [x months after the date of entry into force of this amending directive], the Commission shall review the implementation of this Directive. In the context of that review, its shall consider whether further amendments to this Directive are appropriate, shall assess the feasibility of including endocrine disrupters within the scope of this Directive and, where appropriate, shall present a legislative proposal.”
Amendment 153 #
Proposal for a directive
Article 2 – paragraph 1 h (new)
Article 2 – paragraph 1 h (new)
2004/37/EC
Article 18 a – paragraph 7 c (new)
Article 18 a – paragraph 7 c (new)
(8) 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 a definition of ‘carcinogenic occupations’. A non- exhaustive list of such occupations shall be annexed to this Directive.”
Amendment 154 #
Proposal for a directive
Article 2 – paragraph 1 i (new)
Article 2 – paragraph 1 i (new)
Directive 2004/37/EC
Article 18 a – paragraph 7 d (new)
Article 18 a – paragraph 7 d (new)
(9) 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, in particular the protection and reduction of exposure for workers whose blood-level levels are above the biological limit value. Those guidelines shall be published on the EU- OSHA website and shall be disseminated in all Member States by the relevant competent authorities.”
Amendment 155 #
Proposal for a directive
Article 2 – paragraph 1 j (new)
Article 2 – paragraph 1 j (new)
Directive 2004/37/EC
Article 18 a – paragraph 7 e (new)
Article 18 a – paragraph 7 e (new)
(9) in Article 18a, the following paragraph is added: “No later than 31 December 2023, the Commission shall, after consulting the Advisory Committee for Safety and Health at Work (ACSH) and taking into account the existing recommendations from different agencies, stakeholders and the World Health Organization on 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. No later than 31 December 2024, the Commission shall, taking into account that 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 of the ACSH, present a legislative proposal.”
Amendment 162 #
Proposal for a directive
Article 2 – paragraph 1
Article 2 – paragraph 1
Annexes I, III and IIIa to Directive 2004/37/EC are amended in accordance with Annex II to this Directive.
Amendment 169 #
Proposal for a directive
Annex II – paragraph 1 – introductory part
Annex II – paragraph 1 – introductory part
Annexes I, III and IIIa to Directive 2004/37/EC are amended as follows:
Amendment 170 #
Proposal for a directive
Annex II – paragraph 1 a (new)
Annex II – paragraph 1 a (new)
2004/37/EC
Annex I – title
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))”
Amendment 174 #
Proposal for a directive
Annex II – paragraph -1 b (new)
Annex II – paragraph -1 b (new)
2004/37/EC
Annex I – point 8 a (new)
Annex I – point 8 a (new)
(-1b) in Annex I, the following point is added: “8a. Work involving exposure to hazardous medicinal products.”
Amendment 185 #
Proposal for a directive
Annex II – paragraph 1 – point 2
Annex II – paragraph 1 – point 2
2004/37/EC
Annex III a
Annex III a
Amendment 190 #
Proposal for a directive
Annex II – paragraph 1 – point 2
Annex II – paragraph 1 – point 2
Medical surveillance is carried out if exposure to a concentration of lead in air is greater than 0,01502 mg/m3, calculated as a time-weighted average over 40 hours per week, or a blood-lead level greater than 92.7 μg Pb/100 ml blood is measured in individual workers. If the results of the medical surveillance reveal a blood-lead level of a worker greater than the biological limit value due to historical occupational exposure to lead, the employer and the authority responsible for the health surveillance of that worker shall take the necessary measures to ensure a decrease of the worker’s blood-lead level in accordance with the guidelines developed pursuant to Article 18a.