Sittings · Compare

What changed

From · act followup · 2024-04-30 SP-2024-196-TA-9-2024-0066 Follow up to T9-0066/2024
To · Plenary report · 2023-09-08 A-9-2023-0263 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
+614 added · −14 removed · 0 modified paragraphs

ORDINARY LEGISLATIVE procedure

PR_COD_1amCom

Follow up to the European Parliament legislative resolution 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

Symbols for procedures

1. Rapporteur: Nikolaj VILLUMSEN (the Left / DK)

* Consultation procedure

2. Reference numbers: 2023/0033 (COD) / A9-0263/2023 / P9_TA(2024)0066

*** Consent procedure

3. Date of adoption of the resolution: 7 February 2024

***I Ordinary legislative procedure (first reading)

4. Legal basis: Article 153(2), point (b), in conjunction with paragraph 1, point (a) of the Treaty on the Functioning of the European Union

***II Ordinary legislative procedure (second reading)

5. Competent Parliamentary Committee: Committee on Employment and Social Affairs (EMPL)

***III Ordinary legislative procedure (third reading)

6. Commission's position: accepts all amendments. The Commission presented the following statement:

(The type of procedure depends on the legal basis proposed by the draft act.)

The Commission recalls that the right of initiative accorded to it under the Treaties includes the right to decide whether or not to submit a legislative proposal and, including, as the case may be, to determine the subject-matter, objective, content and timeline of such proposal and/or related action. The provisions of the Directive which request the Commission to review the limit values for lead and its inorganic compounds and for diisocyanates,

Amendments to a draft act

to develop guidelines on health surveillance and biological monitoring regarding lead,

Amendments by Parliament set out in two columns

to assess the effects of exposure to a combination of substances with a view to develop Union guidelines,

Deletions are indicated in bold italics in the left-hand column. Replacements are indicated in bold italics in both columns. New text is indicated in bold italics in the right-hand column.

to assess the appropriateness of including endocrine disruptors within the scope of the Directive

The first and second lines of the header of each amendment identify the relevant part of the draft act under consideration. If an amendment pertains to an existing act that the draft act is seeking to amend, the amendment heading includes a third line identifying the existing act and a fourth line identifying the provision in that act that Parliament wishes to amend.

must thus be understood as being without prejudice to the Commission’s right of initiative under the Treaties.

Amendments by Parliament in the form of a consolidated text

The Commission declares that any possible legislative proposal and/or action on any of the above-mentioned issues will be prepared in adherence to the well-established process in the area of occupational safety and health, and within the requisite timelines, thorough consultation and involvement of social partners and external stakeholders, and in line with its Better Regulation agenda. Besides the two-stage consultation of social partners set out in Article 154 TFEU, this process includes the consultation of the tripartite Advisory Committee on Safety and Health at Work, the opinion of the Risk Assessment Committee of the European Chemicals Agency and an impact assessment.

New text is highlighted in bold italics. Deletions are indicated using either the ▌symbol or strikeout. Replacements are indicated by highlighting the new text in bold italics and by deleting or striking out the text that has been replaced.

By way of exception, purely technical changes made by the drafting departments in preparing the final text are not highlighted.

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

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 – C90022/2023 – 2023/0033(COD))

(Ordinary legislative procedure: first reading)

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

– having regard to Article 294(2) and Article 153(2), point (b), in conjunction with paragraph 1, point (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,

– 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.

Amendment 1

Proposal for a directive

Recital 1 a (new)

Text proposed by the Commission

Amendment

(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.

Amendment 2

Proposal for a directive

Recital 6

Text proposed by the Commission

Amendment

(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.

(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.

Amendment 3

Proposal for a directive

Recital 7 a (new)

Text proposed by the Commission

Amendment

(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

Amendment 4

Proposal for a directive

Recital 7 b (new)

Text proposed by the Commission

Amendment

(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 5

Proposal for a directive

Recital 7 c (new)

Text proposed by the Commission

Amendment

(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.

Amendment 6

Proposal for a directive

Recital 8 a (new)

Text proposed by the Commission

Amendment

(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.

Amendment 7

Proposal for a directive

Recital 9

Text proposed by the Commission

Amendment

(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.

(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 women of childbearing age should not exceed the BGV of 4.5 µg/100ml, as recommended by the opinion of the RAC92. Due to a continuous decline in environmental lead exposure levels, this value should be revisited every five years. 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/cb9293be-4563-4f19-89cf-4c4588bd6541/library/60b206e1-ee10-40c2-9540-fb6510c11a0c/details

90 ACSH opinion on lead (2021). https://circabc.europa.eu/ui/group/cb9293be-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.)

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/ed7a37e4-1641-b147-aaac-fce4c3014037

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/ed7a37e4-1641-b147-aaac-fce4c3014037

Amendment 8

Proposal for a directive

Recital 9 a (new)

Text proposed by the Commission

Amendment

(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.

Amendment 9

Proposal for a directive

Recital 9 b (new)

Text proposed by the Commission

Amendment

(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.

Amendment 10

Proposal for a directive

Recital 9 c (new)

Text proposed by the Commission

Amendment

(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.

Amendment 11

Proposal for a directive

Recital 12

Text proposed by the Commission

Amendment

(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/m³ and a short-term exposure limit of 12 µg/m³ for this group of chemical agents and to assign a skin, dermal and respiratory sensitisation notation to it.

(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 12

Proposal for a directive

Recital 13

Text proposed by the Commission

Amendment

(13) It may be difficult to comply with an occupational exposure limit equal to 6 µg/m³ for diisocyanates, accompanied by an associated short-term exposure limit equal to 12 µg/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/m³ with an associated short-term exposure limit equal to 20 µg/m³ should apply until 31 December 2028.

(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 13

Proposal for a directive

Recital 14

Text proposed by the Commission

Amendment

(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, 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.

(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.

__________________

__________________

93 See footnote 8.

93 See footnote 8.

94 ACSH opinion on diisocyanates (2021) https://circabc.europa.eu/ui/group/cb9293be-4563-4f19-89cf-4c4588bd6541/library/0d11d394-b1e8-4e1a-a962-5ad60f4ab2ae/details

94 ACSH opinion on diisocyanates (2021) https://circabc.europa.eu/ui/group/cb9293be-4563-4f19-89cf-4c4588bd6541/library/0d11d394-b1e8-4e1a-a962-5ad60f4ab2ae/details

Amendment 14

Proposal for a directive

Recital 14 a (new)

Text proposed by the Commission

Amendment

(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.

Amendment 15

Proposal for a directive

Recital 14 b (new)

Text proposed by the Commission

Amendment

(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.

Amendment 16

Proposal for a directive

Recital 15 a (new)

Text proposed by the Commission

Amendment

(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.

Amendment 17

Proposal for a directive

Recital 15 b (new)

Text proposed by the Commission

Amendment

(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.

Amendment 18

Proposal for a directive

Recital 15 c (new)

Text proposed by the Commission

Amendment

(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).

Amendment 19

Proposal for a directive

Recital 15 d (new)

Text proposed by the Commission

Amendment

(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.

Amendment 20

Proposal for a directive

Recital 15 e (new)

Text proposed by the Commission

Amendment

(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.

Amendment 21

Proposal for a directive

Recital 15 f (new)

Text proposed by the Commission

Amendment

(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 stringent occupational safety and health regulations needs to be avoided at all times, while offering the highest level of protection for workers in the Union .

Amendment 22

Proposal for a directive

Recital 15 g (new)

Text proposed by the Commission

Amendment

(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.

Amendment 23

Proposal for a directive

Recital 15 h (new)

Text proposed by the Commission

Amendment

(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.

Amendment 24

Proposal for a directive

Recital 15 i (new)

Text proposed by the Commission

Amendment

(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.

Amendment 25

Proposal for a directive

Article 1 – paragraph 1 – point -1 (new)

Directive 98/24/EC

Article 12 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

(-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.’;

Amendment 26

Proposal for a directive

Article 2 – paragraph 1 – introductory wording (new)

Text proposed by the Commission

Amendment

Directive 2004/37/EC is amended as follows:

Amendment 27

Proposal for a directive

Article 2 – paragraph 1 – point 1 (new)

Directive 2004/37/EC

Article 2 – point b

Present text

Amendment

(1) in Article 2(1), point (b) is replaced by the following:

(b) ‘mutagen’ means: 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;

"(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 28

Proposal for a directive

Article 2 – paragraph 1 – point 2 (new)

Directive 2004/37/EC

Article 2 – point ba

Present text

Amendment

(2) in Article 2(1), point (ba) is replaced by the following:

(ba) ‘reprotoxic substance’ means a substance or mixture, which meets the criteria for classification as a category 1A or 1B reproductive toxicant set out in Annex I to Regulation (EC) No 1272/2008;

"(ba) ‘reprotoxic substance’ means:

(i) a substance or mixture, which meets the criteria for classification as a category 1A or 1B reproductive toxicant set out in Annex I to Regulation (EC) No 1272/2008;

(ii) a substance, mixture or process referred to in Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex; "

Amendment 29

Proposal for a directive

Article 2 – paragraph 1 – point 3 (new)

Directive 2004/37/EC

Article 2 – point e a (new)

Present text

Amendment

(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 30

Proposal for a directive

Article 2 – paragraph 1 – point 4 (new)

Directive 2004/37/EC

Article 5 – paragraph 4

Present text

Amendment

(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.

“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.”

Amendment 31

Proposal for a directive

Article 2 – paragraph 1 – point 5 (new)

Directive 2004/37/EC

Article 5 – paragraph 4 a (new)

Present text

Amendment

(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.”;

Amendment 32

Proposal for a directive

Article 2 – paragraph 1 – point 6 (new)

Directive 2004/37/EC

Article 18a – paragraph 7

Present text

Amendment

(6) in Article 18a, paragraph 7 is replaced by the following:

No later than 31 December 2024, the Commission shall, taking into account the latest developments in scientific knowledge, and after appropriate consultation of relevant stakeholders, propose, where appropriate, a limit value for cobalt and inorganic cobalt compounds.

“No later than 31 December 2023, the Commission shall, after consulting the ACSH, taking into account the RAC’s 2018 opinion and the latest developments in scientific knowledge, where appropriate, submit a legislative proposal to introduce a limit value for cobalt and inorganic cobalt compounds.”;

Amendment 33

Proposal for a directive

Article 2 – paragraph 1 – point 7 (new)

Directive 2004/37/EC

Article 18a – paragraph 7 a (new)

Present text

Amendment

(7) 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(4a) 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 34

Proposal for a directive

Article 2 – paragraph 1 – point 8 (new)

Directive 2004/37/EC

Article 18a – point 7 b (new)

Present text

Amendment

(8) in Article 18a, the following paragraph is added:

“By ... [12 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, it 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 shall, where appropriate, submit to the European Parliament and to the Council a legislative proposal.”;

Amendment 35

Proposal for a directive

Article 2 – paragraph 1 – point 9 (new)

Directive 2004/37/EC

Article 18a – paragraph 7 c (new)

Present text

Amendment

(9) in Article 18a, the following paragraph is added:

‘By... [five years after the date of entry into force of this amending directive] and every five years thereafter, the Commission shall review 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, laid down in Annex III and IIIa, taking into account the negative impacts on the reproductive capacity of female workers of childbearing age as well as on foetal development in order to ensure equal protection for all workers regardless of their gender as well as taking into account up-to-date scientific data and the classification of lead as a non-threshold reprotoxic.’

Amendment 36

Proposal for a directive

Article 2 – paragraph 1 – point 10 (new)

Directive 2004/37/EC

Article 18a – paragraph 7 d (new)

Present text

Amendment

(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.”;

Amendment 37

Proposal for a directive

Article 2 – paragraph 1 – point 11 (new)

Directive 2004/37/EC

Article 18a – paragraph 7 e (new)

Present text

Amendment

(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.”

Amendment 38

Proposal for a directive

Article 2 – paragraph 1 – point 12 (new)

Directive 2004/37/EC

Article 18a – paragraph 7 f (new)

Text proposed by the Commission

Amendment

(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.”;

Amendment 39

Proposal for a directive

Article 2 – paragraph 1 – point 13 (new)

Directive 2004/37/EC

Article 18a – paragraph 7 g (new)

Present text

Amendment

(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.”

Amendment 40

Proposal for a directive

Article 2 – paragraph 1 – point 14 (new)

Directive 2004/37/EC

Article 18a – paragraph 7 h (new)

Text proposed by the Commission

Amendment

(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.”;

Amendment 41

Proposal for a directive

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

Annexes III and IIIa to Directive 2004/37/EC are amended in accordance with Annex II to this Directive.

Annexes I, III and IIIa to Directive 2004/37/EC are amended in accordance with Annex II to this Directive.

Amendment 42

Proposal for a directive

Annex I

Directive 98/24/EC

Annex I

Text proposed by the Commission

Annex I to Directive 98/24/EC is replaced by the following:

ANNEX I

LIST OF BINDING OCCUPATIONAL EXPOSURE LIMIT VALUES

Name of agent

EC No (1)

CAS No (2)

Limit values

Notation

Transitional measures

8 hours (3)

Short-term (4)

µg/m3

(5)

Ppm (6)

f/ml (7)

µg/m3

ppm

Diisocyanates

6

12

Skin (8) Dermal and respiratory sensitisation (9)

The limit value of 10 µg/m3 in relation to a reference period of eight hours and a short-term exposure limit value of 20 µg/m3 shall apply until 31 December 2028.

(1) EC No, i.e., Einecs, ELINCS or NLP, is the official number of the substance within the European Union, as defined in Section 1.1.1.2 in Annex VI, Part 1, to Regulation (EC) No 1272/2008.

(2) CAS No: Chemical Abstract Service Registry Number.

(3) Measured or calculated in relation to a reference period of eight hours time-weighted average (TWA).

(4) Short-term exposure limit (STEL). A limit value above which exposure should not occur and which is related to a 15-minute period unless otherwise specified.

(5) µg/m3 = micrograms per cubic metre of air.

(6) ppm = parts per million by volume in air (ml/m3).

(7) f/ml = fibres per millilitre.

(8) The substance can cause sensitisation of the skin.

(9) The substance can cause sensitisation of the skin and of the respiratory tract.’.

Amendment

Annex I to Directive 98/24/EC is replaced by the following:

ANNEX I

LIST OF BINDING OCCUPATIONAL EXPOSURE LIMIT VALUES

Name of agent

EC No (1)

CAS No (2)

Limit values

Notation

Transitional measures

8 hours (3)

Short-term (4)

µg NCO/m3

(5)

Ppm (6)

f/ml (7)

µg NCO/m3

ppm

Diisocyanates

6

12

Skin (8) Dermal and respiratory sensitisation (9)

The limit value of 10 µg NCO/m3 in relation to a reference period of eight hours and a short-term exposure limit value of 20 µg NCO/m3 shall apply until 31 December 2028.

(1) EC No, i.e., Einecs, ELINCS or NLP, is the official number of the substance within the European Union, as defined in Section 1.1.1.2 in Annex VI, Part 1, to Regulation (EC) No 1272/2008.

(2) CAS No: Chemical Abstract Service Registry Number.

(3) Measured or calculated in relation to a reference period of eight hours time-weighted average (TWA).

(4) Short-term exposure limit (STEL). A limit value above which exposure should not occur and which is related to a 15-minute period unless otherwise specified.

(5) Measured as µg NCO /m3 = micrograms of NCO/isocyanate group from diisocyanate per cubic metre of air.

(6) ppm = parts per million by volume in air (ml/m3).

(7) f/ml = fibres per millilitre.

(8) The substance can cause sensitisation of the skin.

(9) The substance can cause sensitisation of the skin and of the respiratory tract.’.

Amendment 43

Proposal for a directive

Annex II – introductory wording

Text proposed by the Commission

Amendment

Annexes III and IIIa to Directive 2004/37/EC are amended as follows:

Annexes I, III and IIIa to Directive 2004/37/EC are amended as follows:

Amendment 44

Proposal for a directive

Annex II – point -1 a (new)

Directive 2004/37/EC

Annex I – title

Present text

Amendment

(-1) in Annex I, the title is amended as follows:

List of substances, preparations and processes

"List of substances, preparations and processes

(Article 2(a)(iii))

(Article 2(a)(ii), 2(b)(ii), 2(ba)(ii))”;

Amendment 45

Proposal for a directive

Annex II – point -1 a (new)

Directive 2004/37/EC

Annex I – point 8 a (new)

Present text

Amendment

(-1a) in Annex I, the following point is added:

“8a. Work involving exposure to hazardous medicinal products.”;

Amendment 46

Proposal for a directive

Annex II – point 1

Directive 2004/37/EC

Annex III – point A – row 31

Text proposed by the Commission

(1) in Annex III, point A, the row related to inorganic lead and its compounds is replaced by the following:

Name of agent

EC No (1)

CAS No (2)

Limit values

Notation

Transitional measures

8 hours (3)

Short-term (4)

mg/m3 (5)

Ppm (6)

f/ml (7)

mg/m3

ppm

f/ml

Inorganic lead and its compounds

0.03

(1) EC No, i.e. Einecs, ELINCS or NLP, is the official number of the substance within the European Union, as defined in Section 1.1.1.2 in Annex VI, Part 1, to Regulation (EC) No 1272/2008.

(2) CAS No: Chemical Abstract Service Registry Number.

(3) Measured or calculated in relation to a reference period of eight hours time-weighted average (TWA)

(4) Short-term exposure limit (STEL). A limit value above which exposure should not occur and which is related to a 15-minute period unless otherwise specified.

(5) mg/m3 = milligrams per cubic metre of air at 20 °C and 101,3 kPa (760 mm mercury pressure)

(6) ppm = parts per million by volume in air (ml/m3).

(7) f/ml = fibres per millilitre.’;

Amendment

(1) in Annex III, point A, the row related to inorganic lead and its compounds is replaced by the following:

Name of agent

EC No (1)

CAS No (2)

Limit values

Notation

Transitional measures

8 hours (3)

Short-term (4)

mg/m3 (5)

Ppm (6)

f/ml (7)

mg/m3

ppm

f/ml

Inorganic lead and its compounds

0.03

Non-threshold reprotoxic substance

(1) EC No, i.e. Einecs, ELINCS or NLP, is the official number of the substance within the European Union, as defined in Section 1.1.1.2 in Annex VI, Part 1, to Regulation (EC) No 1272/2008.

(2) CAS No: Chemical Abstract Service Registry Number.

(3) Measured or calculated in relation to a reference period of eight hours time-weighted average (TWA)

(4) Short-term exposure limit (STEL). A limit value above which exposure should not occur and which is related to a 15-minute period unless otherwise specified.

(5) mg/m3 = milligrams per cubic metre of air at 20 °C and 101,3 kPa (760 mm mercury pressure)

(6) ppm = parts per million by volume in air (ml/m3).

(7) f/ml = fibres per millilitre.’;

Amendment 47

Proposal for a directive

Annex II – point 2

Directive 2004/37/EC

Annex IIIa

Text proposed by the Commission

Amendment

(2) Annex IIIa is replaced by the following:

(2) Annex IIIa is replaced by the following:

‘ANNEX IIIa (Article 16(4))

‘ANNEX IIIa (Article 16(4))

BIOLOGICAL LIMIT VALUES AND HEALTH SURVEILLANCE MEASURES

BIOLOGICAL LIMIT VALUES AND HEALTH SURVEILLANCE MEASURES

(Article 16(4))

(Article 16(4))

Lead and its ionic compounds

Lead and its inorganic compounds

Biological monitoring must include measuring the blood-lead level (PbB) using absorption spectrometry or a method giving equivalent results. The binding biological limit value is:

Biological monitoring must include measuring the blood-lead level (PbB) using absorption spectrometry or a method giving equivalent results. The binding biological limit value is:

15 μg Pb/100 ml blood(1)

15 μg Pb/100 ml blood(1)

If the results of the medical surveillance reveal a blood-lead level of a worker greater than 30 μg Pb/100 ml blood, the employer and the authority responsible for the health surveillance of that worker shall ensure that the worker is no longer exposed to lead in accordance with the guidelines developed pursuant to Article 18a.

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.

Specific measures, shall be put in place with regard to risk management, including specific and regular health surveillance, high standards for personal protective equipment and regular blood-lead checks. Under the general requirement of Directive 2004/37/EC, employers are obliged to ensure the substitution of the substances when technically possible, the use of closed systems, or the reduction of exposure to as low as technically possible.

Medical surveillance is carried out if exposure to a concentration of lead in air is greater than 0,015 mg/m3, calculated as a time-weighted average over 40 hours per week, or a blood-lead level greater than 9 μg Pb/100 ml blood is measured in individual workers.

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 female workers of childbearing age does not exceed the reference values of the general population not occupationally exposed to lead in the respective EU Member State. When national reference levels are not available, it is recommended that blood lead levels in women female workers of childbearing age do not exceed the Biological Guidance Value of 4.5 µg/100ml.’

(1) It is recommended that the blood lead level in female workers of childbearing age does not exceed the reference values of the general population not occupationally exposed to lead in the respective EU Member State. When national reference levels are not available, it is recommended that blood lead levels in women female workers of childbearing age do not exceed the Biological Guidance Value of 4.5 µg/100ml.’ Due to a continuous decline in environmental lead exposure levels, this value shall be revised every five years.

EXPLANATORY STATEMENT

The protection of workers’ health and safety is enshrined in the Treaties and the Charter of Fundamental Rights and is a key element of an EU economy that works for people. The right to a high level of protection of health and safety at work is reflected in principle 10 of the European Pillar of Social Rights, and is fundamental for reaching the United Nations’ sustainable development goals.

No one should suffer from job related deaths, diseases or accidents. The EU occupational safety and health (OSH) legislation is therefore a major regulatory area that concerns almost 170 million workers in the EU. Policy initiatives such as the European Green Deal or the Critical Raw Material Initiative promote sustainable development, which requires a balance between environmental, economic, and social considerations. By enacting binding occupational exposure limits against 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 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.

In the new 2021-2027 OSH framework, the Union commits to new protective limit values on diisocyanates and lead, which have been identified in the 2020 chemicals strategy as some of the most harmful chemical substances to act upon.

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.

Diisocyanates

Diisocyanates are used to produce polyurethane, a key material for a range of applications such as insulation in buildings and appliances, which contributes to the European Green Deal targets by reducing CO2 emissions through energy efficiency. However, Diisocyanates are hazardous chemical agents that can cause occupational asthma and dermal occupational disease – allergic reactions that can occur due to exposure to such substances. According to estimates, approximately 4.2 million workers are exposed to diisocyanates, which makes Diisocyanates one of the most common causes of occupational asthma, and more than 2.4 million companies in the EU are concerned.

Tripartite consensus on limit values.

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 the limit values and 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.

Lead

Lead currently has a large variety of industrial applications. Lead is an occupational reprotoxic substance that accumulates in the body due to exposure and can affect sexual function and fertility for both men and women, and the development of the foetus or offspring (developmental toxicity). Exposure to lead may result in impaired fertility, miscarriages or serious birth defects, as well as in other harmful effects such as neurotoxicity, renal toxicity, cardiovascular effects and haematological effects. Lead accounts for around half of all occupational exposures to reprotoxic substances and associated cases of reproductive ill-health. Currently, it is estimated that approximately 50 000 to 150 000 workers in the EU are exposed to lead. The current EU binding occupational exposure limit (OEL) and biological limit value (BLV) have not been updated for over 40 years.

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.

Historical exposure

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,

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.

Combined exposure

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.

Definition of carcinogenic occupations

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.

Endocrine disruptors and additional substances

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.

Informal work

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.

ANNEX: LIST OF ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT

The following list is drawn up on a purely voluntary basis under the exclusive responsibility of the rapporteur. The rapporteur has received input from the following entities or persons in the preparation of the [draft report / report, until the adoption thereof in committee]:

Entity and/or person

BusinessEurope

European Trade Union Confederation - ETUC

SMEUnited - European Association of Craft, Small and Medium Sized Enterprises

European Federation of Public Service Unions - EPSU

SGI Europe - European Centre of Employers and Enterprises providing Public Services

European Trade Union Institute - ETUI

ISOPA

ALIPA

Danish Trade Union Confederation - FH

European Commission

PROCEDURE – COMMITTEE RESPONSIBLE

Title

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

References

COM(2023)0071 – C9-0022/2023 – 2023/0033(COD)

Date submitted to Parliament

13.2.2023

Committee responsible

Date announced in plenary

EMPL

13.3.2023

Committees asked for opinions

Date announced in plenary

ENVI

13.3.2023

Not delivering opinions

Date of decision

ENVI

23.3.2023

Rapporteurs

Date appointed

Nikolaj Villumsen

10.3.2023

Discussed in committee

28.6.2023

Date adopted

7.9.2023

Result of final vote

+:

–:

0:

37

4

3

Members present for the final vote

Marc Angel, Dominique Bilde, Vilija Blinkevičiūtė, Milan Brglez, Sylvie Brunet, Jordi Cañas, David Casa, Ilan De Basso, Margarita de la Pisa Carrión, Özlem Demirel, Jarosław Duda, Estrella Durá Ferrandis, Rosa Estaràs Ferragut, Loucas Fourlas, Chiara Gemma, Helmut Geuking, Elisabetta Gualmini, Alicia Homs Ginel, Agnes Jongerius, Radan Kanev, Katrin Langensiepen, Elena Lizzi, Max Orville, Sandra Pereira, Kira Marie Peter-Hansen, Dragoş Pîslaru, Dennis Radtke, Elżbieta Rafalska, Pirkko Ruohonen-Lerner, Mounir Satouri, Monica Semedo, Eugen Tomac, Romana Tomc, Nikolaj Villumsen, Maria Walsh, Stefania Zambelli

Substitutes present for the final vote

Alex Agius Saliba, Alexander Alexandrov Yordanov, Catherine Amalric, Carmen Avram, Lina Gálvez Muñoz, Eugenia Rodríguez Palop

Substitutes under Rule 209(7) present for the final vote

Irena Joveva, Ana Miranda

Date tabled

8.9.2023

FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE

Key to symbols: