Changes from plenary report to adopted text

RemovedDRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

AddedP9_TA(2024)0066

Changedon 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 limitLimit values for lead and its inorganic compounds and diisocyanates

Removed(COM(2023)0071 – C90022/2023 – 2023/0033(COD))

AddedCommittee on Employment and Social Affairs

AddedPE746.964

AddedEuropean Parliament legislative resolution of 7 February 2024 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 (COM(2023)0071 – C9-0022/2023 – 2023/0033(COD))

(Ordinary legislative procedure: first reading)

The European Parliament,

– having regard to the Commission proposal to Parliament and the Council (COM(2023)0071),

Changed– having regard to Article 294(2) and Article 153(2), point (b), in conjunction with paragraph 1, point (a)(a), of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90022/2023),

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

– having regard to the opinion of the Economic and Social Committee of 22 March 2023,

Change 1

Added– after consulting the Committee of the Regions,

Added– having regard to the provisional agreement approved by the committee responsible under Rule 74(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 6 December 2023 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

▸5 unchanged paragraphs

– having regard to Rule 59 of its Rules of Procedure,

– having regard to the report of the Committee on Employment and Social Affairs (A9-0263/2023),

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 2

RemovedRecital 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.

AddedP9_TC1-COD(2023)0033

RemovedRecital 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.

AddedPosition of the European Parliament adopted at first reading on 7 February 2024 with a view to the adoption of Directive (EU) 2024/… of the European Parliament and of the Council amending Directive 2004/37/EC of the European Parliament and of the Council and Council Directive 98/24/EC as regards the limit values for lead and its inorganic compounds and for diisocyanates

RemovedRecital 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. / 1a https://echa.europa.eu/documents/10162/ed7a37e4-1641-b147-aaac-fce4c3014037

Added(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Directive (EU) 2024/869).

RemovedRecital 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.

RemovedRecital 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.

RemovedRecital 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.

RemovedRecital 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…

RemovedRecital 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.

RemovedRecital 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.

RemovedRecital 9 c (new): (9c) There is a need for in-depth knowledge on the long-term effect of lead and its inorganic compounds. Member States authorities should ensure, in particular, that the measures on the prevention and reduction of exposure measures for workers set out in Article 5 of Directive 2004/37/EC, as well as the information and training requirements provided for in Articles 11 and 12 and hygiene and individual protection measures set out in Article 10 of that Directive take into consideration the vulnerable situation of women in childbearing age.

RemovedRecital 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.

RemovedRecital 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.

RemovedRecital 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.

RemovedRecital 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.

RemovedRecital 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.

RemovedRecital 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.

RemovedRecital 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.

RemovedRecital 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).

RemovedRecital 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.

RemovedRecital 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.

RemovedRecital 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…

RemovedRecital 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.

RemovedRecital 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.

RemovedRecital 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.

RemovedDirective 98/24/EC

RemovedArticle 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.’;

RemovedArticle 2 – paragraph 1 – introductory wording (new): Directive 2004/37/EC is amended as follows:

RemovedDirective 2004/37/EC

RemovedArticle 2 – paragraph 1 – point 1 (new), Article 2 – 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; "

RemovedDirective 2004/37/EC

RemovedArticle 2 – paragraph 1 – point 2 (new), Article 2 – 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; "

RemovedDirective 2004/37/EC

RemovedArticle 2 – paragraph 1 – 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’ 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.”;

RemovedDirective 2004/37/EC

RemovedArticle 2 – paragraph 1 – point 4 (new), Article 5 – paragraph 4: (4) in Article 5, paragraph 4 is replaced by the following: / “4. Exposure shall not exceed the limit value of a carcinogen, mutagen or a reprotoxic substance as set out in Annex III. Biological levels shall not exceed the biological limit value for a carcinogen, mutagen or a reprotoxic substance as set out in Annex IIIa.”

RemovedDirective 2004/37/EC

RemovedArticle 2 – paragraph 1 – point 5 (new), Article 5 – paragraph 4 a (new): (5) in Article 5, the following paragraph is added: / “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 of such substances in accordance with Union guidelines, pursuant to Article 18a, paragraph 7a.”;