2023/0033(COD) Limit values for lead and its inorganic compounds and diisocyanates
Lead committee dossier:
Progress: Procedure completed
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | EMPL |
VILLUMSEN Nikolaj ( GUE/NGL)
|
FRANSSEN Cindy ( EPP),
DE BASSO Ilan ( S&D),
AMALRIC Catherine ( Renew),
MATTHIEU Sara ( Verts/ALE),
ZAMBELLI Stefania ( ID),
RAFALSKA Elżbieta ( ECR)
|
| Committee Opinion | ENVI |
Lead committee dossier:
Legal Basis:
TFEU 153-p1, TFEU 153-p2
Legal Basis:
TFEU 153-p1, TFEU 153-p2Events
2024/03/19
Final act published in Official Journal
2024/03/13
CSL - Draft final act
Documents
2024/03/13
CSL - Final act signed
2024/02/26
EP/CSL - Act adopted by Council after Parliament's 1st reading
2024/02/07
EP - Decision by Parliament, 1st reading
Details
The European Parliament adopted by 589 votes to 10, with 40 abstentions, a 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.
Parliament's position adopted at first reading under the ordinary legislative procedure should amend the proposal as follows:
Limit values for lead
The proposed directive lays down a revised biological limit value of 15 µg Pb/100 ml blood, accompanied by a revised occupational exposure limit value of 0,03 mg/m3 as an 8-hour time-weighted average (TWA).
A substantial reduction of the biological limit value to 15 µg Pb/100 ml blood may be difficult to comply with in the short term, due to the time needed to implement risk-management measures and the costly adaptation of production processes. Therefore, a transitional period until 31 December 2028 should be introduced during which a biological limit value of 30 µg Pb/100 ml blood applies.
The Commission should, no later than five years from the date of entry into force of this amending Directive, assess the occupational limit values for lead and its inorganic compounds. Where appropriate, the Commission should submit a legislative proposal to amend those limit values.
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 to lead and its inorganic compounds is reduced to as low a level as is technically possible.
No later than two years from the date of entry into force of this amending Directive, the Commission should initiate the procedure to obtain a scientific assessment of endocrine disruptors that can affect the health and safety of workers, with a view to evaluating the appropriateness of including them within the scope of this Directive in order to better protect the health and safety of workers.
Limit values are set for diisocyanates
The new directive sets the occupational exposure limit for diisocyanates at 6 µg NCO/m3 (the maximum concentration that a worker can be exposed to during an eight-hour working day) and at 12 µg NCO/m3 for short-term exposure (i.e., a period of 15 minutes).
A limit value of 10 µg NCO/m3 in relation to a reference period of 8 hours and a short-term exposure limit value of 20 µg NCO/m3 should apply until 31 December 2028.
The Commission will review these limits by 2029.
Medical surveillance
Lead accumulates in the bones and is released slowly into the circulatory system. The blood lead level could thus remain high for a long time after exposure to lead and its inorganic compounds has been reduced. Regular medical surveillance should therefore be carried out for workers whose blood lead level exceeds the biological limit value in force due to exposure which occurred before two years from the date of entry into force of this amending Directive.
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 also carried out with regard to female workers of childbearing age whose blood lead level exceeds 4.5 µg Pb/100 ml blood or the national reference value of the general population not occupationally exposed to lead, if such a value exists.
No later than two years from the date of entry into force of this amending Directive, the Commission should draw up Union guidelines for health surveillance, including biological monitoring. Those guidelines shall include advice on the implementation of provisions regarding blood lead level, taking into account the slow removal of lead from the body and the special protection of female workers of childbearing age.
Documents
2024/02/06
EP - Debate in Parliament
Documents
2024/01/11
EP - Approval in committee of the text agreed at 1st reading interinstitutional negotiations
Documents
2023/09/13
EP - Committee decision to enter into interinstitutional negotiations confirmed by plenary (Rule 71)
2023/09/11
EP - Committee decision to enter into interinstitutional negotiations announced in plenary (Rule 71)
2023/09/08
EP - Committee report tabled for plenary, 1st reading
Details
The Committee on Employment and Social Affairs adopted the report by Nikolaj VILLUMSEN (GUE/NGL, DK) 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 limit values for lead, its inorganic compounds and diisocyanates.
The proposal aims to revise the existing limit values for lead and to introduce limit values for diisocyanates for the first time, thereby helping to achieve a high level of protection for the health and safety of workers.
The committee responsible recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure should amend the Commission's proposal.
Regarding the limit values for lead , the report supports the Commission's proposal to lower the exposure limit value (ELV) from 0.15 milligrams per cubic metre (0.15 mg/m³) to 0.03 mg/m³ and to lower the biological limit value (BLV) from 70 micrograms per 100 millilitres of blood (70µg/100ml) to 15µg/100ml.
With regard to diisocyanates, it is proposed to establish an occupational exposure limit value of 6 µg NCO/m³ and a short-term exposure limit value of 12 µg NCO/m³ for this group of chemical agents.
The report introduces a review mechanism guaranteeing regular revisions in the future to ensure that these limit values are regularly updated, taking into account the latest scientific data.
In particular, the Commission should:
- no later than 31 December 2029, launch a process to review the occupational exposure limit and short-term occupational exposure limit values for diisocyanates;
- draw up Union guidelines on how to adapt the implementation of limit values in the event of exposure to a combination of substances acting by the same mode of action or on the same target cell or tissue;
- no later than 31 December 2023, present a legislative proposal to introduce a limit value for cobalt and inorganic cobalt compounds;
- no later than 12 months after the date of entry into force of the amending Directive, review the implementation of the Directive and, as part of this review, determine whether any further amendments to the Directive are necessary, assess the possibility of including endocrine disrupters within the scope of the Directive and, if appropriate, submit a legislative proposal to the European Parliament and the Council;
- no later than five years after the date of entry into force of the amending Directive and every five years thereafter, 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 , 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;
- twelve months after the date of entry into force of the amending Directive, develop a definition of ‘carcinogenic occupations’ and assess the appropriateness to include such occupations in the scope of this Directive;
- no later than twelve months after the date of entry into force of the amending Directive, 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;
- no later than one year after the directive comes into force, update its action plan aimed at defining occupational exposure limits for at least 5 substances or groups of substances or substances produced by additional processes. These include lithium and its compounds, methyl hydrazine, 1,3-propanesultone, welding fumes and leather dust;
- no later than twelve months after the date of entry into force of the amending directive, to consider, in consultation with the 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;
- no later than 1 January 2028, assess the feasibility of further reducing the limit value for benzene and present, if appropriate, the necessary legislative amendments to this Directive no later than 1 January 2030.
Documents
2023/09/07
EP - Vote in committee, 1st reading
2023/09/07
EP - Committee decision to open interinstitutional negotiations with report adopted in committee
2023/06/08
EP - Amendments tabled in committee
Documents
2023/05/08
EP - Committee draft report
Documents
2023/04/27
SE_PARLIAMENT - Contribution
Documents
2023/03/22
ESC - Economic and Social Committee: opinion, report
Documents
2023/03/13
EP - Committee referral announced in Parliament, 1st reading
2023/03/10
EP - VILLUMSEN Nikolaj (GUE/NGL) appointed as rapporteur in EMPL
2023/02/13
EC - Legislative proposal
Documents
2023/02/13
EC - Document attached to the procedure
Documents
2023/02/13
EC - Document attached to the procedure
Documents
2023/02/13
EC - Document attached to the procedure
Documents
2023/02/13
EC - Document attached to the procedure
Documents
2023/02/13
EC - Legislative proposal published
Documents
Documents
- Draft final act: 00081/2023/LEX
- Decision by Parliament, 1st reading: T9-0066/2024
- Debate in Parliament: Debate in Parliament
- Approval in committee of the text agreed at 1st reading interinstitutional negotiations: PE757.939
- Committee report tabled for plenary, 1st reading: A9-0263/2023
- Amendments tabled in committee: PE749.282
- Committee draft report: PE746.964
- Contribution: COM(2023)0071
- Economic and Social Committee: opinion, report: CES1367/2023
- Legislative proposal: EUR-Lex
- Legislative proposal: COM(2023)0071
- Document attached to the procedure: SEC(2023)0067
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2023)0034
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2023)0035
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2023)0036
- Legislative proposal published: EUR-Lex
- Legislative proposal published: COM(2023)0071
- Legislative proposal: EUR-Lex COM(2023)0071
- Document attached to the procedure: SEC(2023)0067
- Document attached to the procedure: EUR-Lex SWD(2023)0034
- Document attached to the procedure: EUR-Lex SWD(2023)0035
- Document attached to the procedure: EUR-Lex SWD(2023)0036
- Economic and Social Committee: opinion, report: CES1367/2023
- Committee draft report: PE746.964
- Amendments tabled in committee: PE749.282
- Draft final act: 00081/2023/LEX
- Contribution: COM(2023)0071
Activities
- Nikolaj VILLUMSEN
Plenary Speeches (2)
- Dominique BILDE
Plenary Speeches (1)
- Elżbieta RAFALSKA
Plenary Speeches (1)
- Stefania ZAMBELLI
Plenary Speeches (1)
- Cindy FRANSSEN
Plenary Speeches (1)
- Ilan DE BASSO
Plenary Speeches (1)
- Catherine AMALRIC
Plenary Speeches (1)
Votes
A9-0263/2023 – Nikolaj Villumsen – Provisional agreement – Am 48 #
2024/02/07 Outcome: +: 589, 0: 40, -: 10
PPE
NI
The Left| Amendments | Dossier |
| 159 |
2023/0033(COD)
2023/06/08
EMPL
159 amendments...
Amendment 100 #
Proposal for a directive Recital 15 b (new) (15b) To ensure a comprehensive level of protection, it is necessary to consider the effects of combined exposure to multiple substances. In the workplace, workers are often exposed to a cocktail of hazardous substances, which can increase risks and cause adverse health effects. In the case of exposure to a combination of substances acting by the same mode of action or at the same target cell or tissue, it is necessary to adapt the implementation of their possible limit values to take into account the combined effects.
Amendment 101 #
Proposal for a directive Recital 15 b (new) (15b) To ensure a comprehensive level of protection, it is necessary to consider the effects of combined exposure to multiple substances. In the workplace, workers are often exposed to a cocktail of hazardous substances, which can increase risks and cause adverse health effects. In the case of exposure to a combination of substances acting by the same mode of action or at the same target cell or tissue, it is necessary to adapt the implementation of their possible limit values to take into account the combined effects.
Amendment 102 #
Proposal for a directive Recital 15 c (new) (15c) The World Health Organization classified the occupational exposure of firefighter as carcinogenic to humans (Group 1). Occupational exposure as a firefighter includes a variety of hazards resulting from fires and non-fire events. Firefighters can be exposed to combustion products from fires, building materials, chemicals in firefighting foams, flame- retardants and diesel exhaust. The uptake of fire effluents or other chemicals can occur via inhalation and dermal absorption and possibly via ingestion. Such workers should therefore be better protected from such exposure.
Amendment 103 #
Proposal for a directive Recital 15 c (new) (15c) The World Health Organization classified the occupational exposure of firefighter as carcinogenic to humans (Group 1). Occupational exposure as a firefighter includes a variety of hazards resulting from fires and non-fire events. Firefighters can be exposed to combustion products from fires, building materials, chemicals in firefighting foams, flame- retardants and diesel exhaust. The uptake of fire effluents or other chemicals can occur via inhalation and dermal absorption and possibly via ingestion. Such workers should therefore be better protected from such exposure.
Amendment 104 #
Proposal for a directive Recital 15 c (new) (15c) The World Health Organization classified the occupational exposure of firefighter as carcinogenic to humans (Group 1). Occupational exposure as a firefighter includes a variety of hazards resulting from fires and non-fire events. Firefighters can be exposed to combustion products from fires, building materials, chemicals in firefighting foams, flame- retardants and diesel exhaust. The uptake of fire effluents or other chemicals can occur via inhalation and dermal absorption and possibly via ingestion. Such workers should therefore be better protected from such exposure.
Amendment 105 #
Proposal for a directive Recital 15 c (new) (15c) 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 106 #
Proposal for a directive Recital 15 d (new) (15d) Union action, such as the European Green Deal launched in the Commission communication of 11 December 2019 and the Critical Raw Material initiative launched in the Commission communication of 16 March 2023 on A secure and sustainable supply of critical raw materials in support of the twin transition1, promote sustainable development, which requires a balance between environmental, economic, and social considerations. By enacting binding occupational exposure limits of carcinogens, mutagens and reprotoxic substances, workers are better protected from harm and can continue to work as safely as possible in industries that produce critical raw materials or contribute to the green economy. This, in turn, promotes a just green and digital transition by ensuring that workers’ health are not compromised at the expense of the Union’s economic and environmental goals. Protecting workers from exposure to hazardous substances also contributes to the objectives of Europe’s Beating Cancer Plan, set out in the Commission communication of 3 February 2021. __________________ 1 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on A secure and sustainable supply of critical raw materials in support of the twin transition (COM(2023) 165 final).
Amendment 107 #
Proposal for a directive Recital 15 d (new) (15d) Union action, such as the European Green Deal launched in the Commission communication of 11 December 2019 and the Critical Raw Material initiative launched in the Commission communication 16 March 2023, entitled ‘A secure and sustainable supply of critical raw materials in support of the twin transition’, promote sustainable development, which requires a balance between environmental, economic, and social considerations. By enacting binding occupational exposure limits of carcinogens, mutagens and reprotoxic substances, workers are better protected from harm and can continue to work as safely as possible in industries that produce critical raw materials or contribute to the green economy. This, in turn, promotes a just green and digital transition by ensuring that workers’ health are not compromised at the expense of the Union’s economic and environmental goals. Protecting workers from exposure to hazardous substances also contributes to the objectives of Europe’s Beating Cancer Plan, set out in the Commission communication of 3 February 2021.1 __________________ 1 https://health.ec.europa.eu/system/files/20 22-02/eu_cancer-plan_en_0.pdf
Amendment 108 #
Proposal for a directive Recital 15 e (new) (15e) Due to unpredictable exposure to certain substances, a mix of substances or constraints in the organisation of work, some occupations should be considered to be carcinogenic per se. It is difficult in some occupations to predict and prepare for the extent to which workers will be exposed to substances or mixes of substances. It is to be expected that the World Health Organization’s list of carcinogenic hazards will be expanded in accordance with the increasing amount of data and the progress of medical and scientific research, which highlight the carcinogenic nature of some occupations. Therefore, a non-exhaustive Union list of occupations that are considered to be carcinogenic would help employers identify recognised professions at risk and would facilitate the implementation of adequate protective measures and training pursuant to Directives 98/24/EC and 2004/37/EC. While the protective measures under Directives 98/24/EC and 2004/37/EC should not be exclusive to occupations on that list, it would provide employers with guidance.
Amendment 109 #
Proposal for a directive Recital 15 e (new) (15e) Due to unpredictable exposure to certain substances, a mix of substances or constraints in the organisation of work, some occupations should be considered to be carcinogenic per se. It is difficult in some occupations to predict and prepare for the extent to which workers will be exposed to substances or mixes of substances. It is to be expected that the World Health Organization’s list of carcinogenic hazards will be expanded in accordance with the increasing amount of data and the progress of medical and scientific research, which highlight the carcinogenic nature of some occupations. Therefore, a non-exhaustive Union list of occupations that are considered to be carcinogenic would help employers identify recognised professions at risk and would facilitate the implementation of adequate protective measures and training pursuant to Directives 98/24/EC and 2004/37/EC. While the protective measures under Directives 98/24/EC and 2004/37/EC should not be exclusive to occupations on that list, it would provide employers with guidance.
Amendment 110 #
Proposal for a directive Recital 15 f (new) (15f) The circular economy and the waste collecting, sorting and recovery sectors are growing fast to meet the objectives of the European Green Deal, to ensure the sustainability of European industry and to ensure greater strategic autonomy to the Union. However, those positive developments raise many occupational health and safety issues for workers in that industry, who, by the very nature of their activity, are likely to be disproportionately exposed to harmful substances. Exposure to lead, mercury and other hazardous metals in waste recycling facilities is for example already a reality for many such workers. Ambitious protective measures, adequate prevention policies, as well as good quality working conditions are necessary to reduce the risks of exposure to hazardous substances and to ensure a high level of protection.
Amendment 111 #
Proposal for a directive Recital 15 f (new) (15f) The circular economy and the waste collecting, sorting and recovery sectors are growing fast to meet the objectives of the European Green Deal, to ensure the sustainability of European industry and to ensure greater strategic autonomy to the Union. However, those positive developments raise many occupational health and safety issues for workers in that industry, who, by the very nature of their activity, are likely to be disproportionately exposed to harmful substances. Exposure to lead, mercury and other hazardous metals in waste recycling facilities is for example already a reality for many such workers. Ambitious protective measures, adequate prevention policies, as well as good quality working conditions are necessary to reduce the risks of exposure to hazardous substances and to ensure a high level of protection.
Amendment 112 #
Proposal for a directive Recital 15 g (new) (15g) The informal sector is proportionally over-represented in the waste collecting, sorting and recovery sectors. A high exposure to risks, including harmful substances, combined with a low level of social protection place most informal economy workers in a very vulnerable situation. Preventive measures, in the form of occupational health and safety management systems and a general safety culture, to reduce risks at work often do not reach the informal economy. Special attention should be paid to those precarious workers in order to offer safe working conditions and environments as well as equal treatment with workers in the same sector or in sectors that are better regulated.
Amendment 113 #
Proposal for a directive Recital 15 g (new) (15g) The informal sector is proportionally over-represented in the waste collecting, sorting and recovery sectors. A high exposure to risks, including harmful substances, combined with a low level of social protection place most informal economy workers in a very vulnerable situation. Preventive measures, in the form of occupational health and safety management systems and a general safety culture, to reduce risks at work often do not reach the informal economy. Special attention should be paid to those precarious workers in order to offer safe working conditions and environments as well as equal treatment with workers in the same sector or in sectors that are better regulated.
Amendment 114 #
Proposal for a directive Recital 15 h (new) (15h) Following the amendments to Annex III to Directive 2004/37/EC, as set out in this Directive, further limit values for additional substances or group of substances and processes should be introduced by the end of 2024. Between 50 and 70 substances or group of substances have been identified by different agencies, stakeholders, and the World Health Organization in priority lists of workplace carcinogens, mutagens and reprotoxic substances for which binding limit values are needed. [The Commission should, no later than the end of 2023, update its action plan to achieve occupational exposure limits for at least 5 additional substances or group of substances or process generated substances.] The additional substances or group of substances referred to in Annex III to Directive 2004/37/EC should include but not be limited to substances and processes such as lithium and lithium compounds, methyl hydrazine, 1,3- propanesultone, welding fumes and leather dust.
Amendment 115 #
Proposal for a directive Recital 15 h (new) (15h) Benzene meets the criteria for classification as carcinogenic (category 1A) in accordance with Regulation (EC) No 1272/2008 and is therefore carcinogen within the meaning of Directive 2004/37/EC. Benzene can also be absorbed through the skin. The limit value set out in Annex III to Directive 2004/37/EC for benzene should be revised in the light of more recent scientific data no later than 1 January 2030 in accordance with the ACSH opinion and it is appropriate to keep the skin notation. The ACSH, based on the RAC opinion, also agreed on the usefulness of the biomonitoring for benzene. This should be considered when developing guidance on the practical use of biomonitoring.
Amendment 116 #
Proposal for a directive Recital 15 i (new) (15i) Following the amendments to Annex III to Directive 2004/37/EC, as set out in this Directive, further limit values for additional substances or group of substances and processes should be introduced by the end of 2024. Between 50 and 70 substances or group of substances have been identified by different agencies, stakeholders, and the World Health Organization in priority lists of workplace carcinogens, mutagens and reprotoxic substances for which binding limit values are needed. [The Commission should, no later than the end of 2023, update its action plan to achieve occupational exposure limits for at least 5 additional substances or group of substances or process generated substances.] The additional substances or group of substances referred to in Annex III to Directive 2004/37/EC should include but not be limited to substances and processes such as lithium and lithium compounds, methyl hydrazine, 1,3- propanesultone, welding fumes and leather dust.
Amendment 117 #
Proposal for a directive Recital 16 a (new) (16a) In implementing this Directive, Member States should avoid imposing financial, administrative and legal constraints in a way which would discourage the establishment and development of small and medium-sized enterprises (SMEs) and micro-enterprises. In this connection, the Member States and the competent bodies of the European Union are called on to provide incentives, guidance and advice to SMEs and micro- enterprises to facilitate conformity with this directive. Against this backdrop, the social partners are encouraged to conclude agreements, issue guidelines and take other joint actions that can identify and advance best practices.
Amendment 118 #
Proposal for a directive Recital 16 a (new) (16a) The Directive should give proper consideration to the needs and special features of the industries and sectors concerned, which often encompass national built, craft and industrial heritage, especially the stained glass and crystal glass industries.
Amendment 119 #
Proposal for a directive Recital 17 a (new) (17a) Companies and artisans, particularly those working in crafts, must be given sufficient time to adapt to the new thresholds laid down in this Directive.
Amendment 120 #
Proposal for a directive Article 1 – paragraph 1 – point -1 (new) Directive 98/24/EC Article 12 – paragraph 2 a (new) (-1) in Article 12, the following paragraph is added: 2a. In line with the opinion of the Advisory Committee on Health and Safety at Work, the Commission shall, no later than 31st December 2029, launch a revision process for the occupational exposure limit and short-term occupational exposure limit for diisocyanates, taking especially into account the evaluation of the REACH Restriction, as Member States should report to the Commission the number of reported cases on occupational asthma, and any relevant data available. The Commission shall, where appropriate, subsequently propose necessary amendments and modifications related to that group of substances in a subsequent revision of this Directive.
Amendment 121 #
Proposal for a directive Article 1 – paragraph 1 – point -1 (new) Directive 98/24/EC Article 12 – paragraph 2 a (new) (-1) in Article 12, the following paragraph is added: 2a. No later than 1 January 2029, the Commission shall launch the process of evaluating the need to modify the binding limit values for diisocyanates and, where appropriate, after consulting the ACSH, shall propose necessary amendments and modifications related to that group of substances in Annex I without delay.
Amendment 122 #
Proposal for a directive Article 2 – paragraph 1 – introductory wording (new) Directive 2004/37/EC is amended as follows:
Amendment 123 #
Proposal for a directive Article 2 – paragraph 1 – introductory wording (new) Directive 2004/37/EC is amended as follows:
Amendment 124 #
Proposal for a directive Article 2 – paragraph 1 – introductory wording (new) Directive 2004/37/EC is amended as follows:
Amendment 125 #
Proposal for a directive Article 2 – paragraph 1 a (new) (1) in Article 2(1), point (b) is replaced by the following: "(b) ‘mutagen’ means: (i) a substance or mixture which meets the criteria for classification as a category 1A or 1B germ cell mutagen set out in Annex I to Regulation (EC) No 1272/2008; (ii) a substance, mixture or process referred to in Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex; "
Amendment 126 #
Proposal for a directive Article 2 – paragraph 1 a (new) Directive 2004/37/EC 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
Amendment 127 #
Proposal for a directive Article 2 – paragraph -1 – point 1 (new) Directive 2004/37/EC 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;"
Amendment 128 #
Proposal for a directive Article 2 – paragraph 1 b (new) Directive 2004/37/EC Article 2 – point b a (2) in Article 2(1), point (ba) is replaced by the following: "(ba) ‘reprotoxic substance’ means: (i) a substance or mixture, which meets the criteria for classification as a category 1A or 1B reproductive toxicant set out in Annex I to Regulation (EC) No 1272/2008; (ii) a substance, mixture or process referred to in Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex; "
Amendment 129 #
Proposal for a directive Article 2 – paragraph 1 b (new) Directive 2004/37/EC Article 2 –point b a (2) in Article 2(1), point (ba) is replaced by the following: "(ba) ‘reprotoxic substance’ means: (i) a substance or mixture, which meets the criteria for classification as a category 1A or 1B reproductive toxicant set out in
Amendment 130 #
Proposal for a directive Article 2 – paragraph -1 – point 3 (new) Directive 2004/37/EC Article 2 – point e a (new) (3) in Article 2(1), the following point is added: “(ea) 'hazardous medicinal products’ or HMP’ means medicinal products that contain one or more substances that meet the criteria for classification as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B) or toxic for reproduction (category 1A or 1B) in accordance with Regulation (EC) No 1272/2008.’
Amendment 131 #
Proposal for a directive Article 2 – paragraph -1 – point 3 (new) Directive 2004/37/EC Article 2 – point e a (new) (3) in Article 2(1), the following point is added: “(ea) 'hazardous medicinal products’ or HMP’ means medicinal products that contain one or more substances that meet the criteria for classification as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B) or toxic for reproduction (category 1A or 1B) in accordance with Regulation (EC) No 1272/2008.”
Amendment 132 #
Proposal for a directive Article 2 – paragraph -1 – point 3 (new) Directive 2004/37/EC Article 2 –– point e a (new) (3) in Article 2(1), the following point is added: “(ea) 'hazardous medicinal products’ or HMP’ means medicinal products that contain one or more substances that meet the criteria for classification as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B) or toxic for reproduction (category 1A or 1B) in accordance with Regulation (EC) No 1272/2008.”
Amendment 133 #
Article 2 – paragraph -1 – point 3 (new) Directive 2004/37/EC Article 2 – point e a (new) (3) in Article 2(1), the following point is added: “(ea) 'hazardous medicinal products’ or HMP’ means medicinal products that contain one or more substances that meet the criteria for classification as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B) or toxic for reproduction (category 1A or 1B) in accordance with Regulation (EC) No 1272/2008.”
Amendment 134 #
Proposal for a directive Article 2 – paragraph -1 b (new) Directive 2004/37/EC Article 5 – paragraph 4 Amendment 135 #
Proposal for a directive Article 2 – paragraph -1 – point 4 (new) Directive 2004/37/EC Article 5 – paragraph 4 a (new) (4) in Article 5, the following paragraph 4a is inserted: “4a. In the case of exposure to a combination of substances acting by the same mode of action or at the same target cell or tissue, the implementation of the possible limit values of those substances shall be adapted to take into account the combined effects in accordance with Union guidelines to be developed pursuant to Article 18a.”
Amendment 136 #
Proposal for a directive Article 2 – paragraph -1 – point 4 (new) Directive 2004/37/EC Article 5 – paragraph 4 a (new) (4) in Article 5, the following paragraph 4a is inserted: “4a. In the case of exposure to a combination of substances acting by the same mode of action or at the same target cell or tissue, the implementation of the possible limit values of those substances shall be adapted to take into account the combined effects in accordance with Union guidelines to be developed pursuant to Article 18a.”
Amendment 137 #
Proposal for a directive Article 2 – paragraph -1 – point 4 (new) Directive 2004/37/EC Article 5 – paragraph 4 a (new) (4) in Article 5, the following paragraph 4a is inserted: “4a. In the case of activities involving exposure to more than one carcinogenic, mutagenic or reprotoxic substance acting by the same mode of action or at the same target cell or tissue, the risk shall be assessed on the basis of the risk presented by all such substances in combination.”
Amendment 138 #
Proposal for a directive Article 2 – paragraph -1 – point 4 (new) Directive 2004/37/EC Article 5 – paragraph 4 a (new) (4) in Article 5, the following paragraph 4a is inserted: "4a. The limit values set out in Annex III for the occupational substance "inorganic lead and its compounds" and Annex IIIa for the occupational substance "lead and its ionic compounds" shall not apply to activities which, in accordance to Annex IIIb, are of substantial importance for the preservation of the cultural heritage and cultural diversity of the European Union."
Amendment 139 #
Proposal for a directive Article 2 – paragraph -1 – point 4 (new) Directive 2004/37/EC Article 5 – paragraph 4 a (new) (4) in Article 5, the following paragraph 4a is inserted: “4a. In the case of exposure to a combination of substances acting by the same mode of action or at the same target cell or tissue, the implementation of the possible limit values of those substances shall be adapted to take into account the combined effects."
Amendment 140 #
Proposal for a directive Article 2 – paragraph 1 e (new) Directive 2004/37/EC Article 5 – paragraph 5 a (new) (5) in Article 5, the following paragraph is added: “5a. Biological levels shall not exceed the biological limit value for a carcinogen, mutagen or a reprotoxic substance set out in Annex IIIa.”
Amendment 141 #
Proposal for a directive Article 2 – paragraph 1 e (new) Directive 2004/37/EC Article 5 – paragraph 5 a (new) (5) in Article 5, the following paragraph is added: “5a. Biological levels shall not exceed the biological limit value for a carcinogen, mutagen or a reprotoxic substance set out in Annex IIIa.”
Amendment 142 #
Proposal for a directive Article 2 – paragraph 1 b (new) Directive 2004/37/EC Article 14 – paragraph 4 a (new) In Article 14, the following paragraph is added: "4a. In case medical surveillance shows that a current or recently updated biological limit value is exceeded because of historical exposure, these workers should be granted a temporary derogation to this biological limit value and be allowed to continue to work. To avoid layoffs, employers should relocate these workers to alternative functions with less exposure. For the duration of this derogation, workers should be subject to enhanced medical surveillance to ensure a downward trend in their blood level. Whenever the continuation of work is not possible, Member States should, based on guidelines developed by the European Commission, ensure their social safety net for workers is covering affected workers, for example by supporting their reskilling."
Amendment 143 #
Proposal for a directive Article 2 – paragraph -1 – point 6 (new) Directive 2004/37/EC Article 18 a – paragraph 7 a (new) (6) in Article 18a, the following paragraph is added: ‘No later than [one year after the date of entry into force of this amending directive] the Commission shall, after consulting the ACSH, develop and publish guidelines on the protection and reduction of exposure for workers whose blood-lead levels are above the biological limit value, on the special protection of women of childbearing age and on the hygiene measures necessary to limit the blood lead level of all workers. Those guidelines shall be published on the EU- OSHA website and shall be disseminated in all Member States by the relevant competent authorities.’
Amendment 144 #
Proposal for a directive Article 2 – paragraph -1 – point 7 (new) Directive 2004/37/EC Article 18 a – paragraph 7 b (new) (7) in Article 18a, the following paragraph is added: ‘No later than [five years after the date of entry into force of this amending directive] and every five years thereafter, the Commission shall, taking into account up-to-date scientific data, review the Biological Guidance Value laid down in annex IIIa, in order to take into account the declining trend of environmental lead exposure levels.’
Amendment 145 #
Proposal for a directive Article 2 – paragraph -1 – point 8 (new) Directive 2004/37/EC Article 18 a – paragraph 7 c (new) (8) in Article 18a, the following paragraph is added: ‘No later than [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 RAC, and after appropriate consultation of relevant stakeholders, prepare Union guidelines on how the implementation of the limit values referred to in Article 5(4) 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 be disseminated in all Member States by the relevant competent authorities.’
Amendment 146 #
Proposal for a directive Article 2 – paragraph -1 – point 9 (new) Directive 2004/37/EC Article 18 a – paragraph 7 d (new) (9) in Article 18a, the following paragraph is added: ‘The Commission shall, as part of the next evaluation of the implementation of this Directive in the context of the evaluation referred to in Article 17a of Directive 89/391/EEC, evaluate the need to include endocrine disrupters within the scope of this Directive. The Commission shall, where appropriate, subsequently propose necessary amendments and modifications related to endocrine disrupters in a subsequent revision of this Directive.’
Amendment 147 #
Proposal for a directive Article 2 – paragraph -1 – point 6 (new) Directive 2004/37/EC Article 18 a – paragraph 7 a (new) (6) 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 on how to further protect women of childbearing age from exposure to lead. These guidelines should include better information sharing and awareness- raising of the harmful effects of exposure to lead on the long term, support to employers on relocation to alternative functions with less exposure to lead within the company or incentives and support to enable reskilling of female workers if relocations proves impossible."
Amendment 148 #
Proposal for a directive Article 2 – paragraph -1 – point 7 (new) Directive 2004/37/EC Article 18 a – paragraph 7 b (new) (7) 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 consult with the social partners and evaluate if the Council Directive 92/85/EEC and its provisions on protection against lead exposure are fit for purpose and consider the inclusion of women of childbearing age, and, if appropriate, put forward a legislative proposal to amend this Directive;"
Amendment 149 #
Proposal for a directive Article 2 – paragraph -1 – point 8 (new) Directive 2004/37/EC Article 18 a – paragraph 7 c (new) (8) in Article 18a, the following paragraph is added: “By ... [twelve months after the date of entry into force of this amending directive], the Commission shall 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, where appropriate, shall present a legislative proposal.”
Amendment 150 #
Proposal for a directive Article 2 – paragraph 1 f (new) Directive 2004/37/EC Article 18 a – paragraph 7 d (new) In Article 18a, the following paragraph is added: “No later than 31 December 2023, the Commission shall, after consulting the ACSH and taking into account the RAC opinion of 2018 and the latest developments in scientific knowledge, present a legislative proposal to introduce the limit value for cobalt and cobalt compounds.”
Amendment 151 #
Proposal for a directive Article 2 – paragraph -1 – point 6 (new) Directive 2004/37/EC Article 18 a – paragraph 7 a (new) (6) in Article 18a, the following paragraph is added: “By ... [one year after the date of entry into force of this amending Directive], the Commission shall, taking into account the latest developments in scientific knowledge and the opinion of the Committee for Risk Assessment of the European Chemicals Agency established by Regulation (EC) No 1907/2006, and after appropriate consultation of relevant stakeholders, prepare Union guidelines on how the implementation of the limit values referred to in Article 5(4) and 5(4b) are to be adapted in the case of exposure to a combination of substances. Those guidelines shall be published on the EU- OSHA website and shall be disseminated in all Member States by the relevant competent authorities.”
Amendment 152 #
Proposal for a directive Article 2 – paragraph 1 g (new) Directive 2004/37/EC Article 18 a – paragraph 7 b (new) (7) in Article 18a, the following paragraph is added: “By ... [x months after the date of entry into force of this amending directive], the Commission shall review the implementation of this Directive. In the context of that review, its shall consider whether further amendments to this Directive are appropriate, shall assess the feasibility of including endocrine disrupters within the scope of this Directive and, where appropriate, shall present a legislative proposal.”
Amendment 153 #
Proposal for a directive Article 2 – paragraph 1 h (new) 2004/37/EC Article 18 a – paragraph 7 c (new) (8) in Article 18a, the following paragraph is added: “By ... [twelve months after the date of entry into force of this amending Directive], the Commission shall, after consulting the ACSH, develop a definition of ‘carcinogenic occupations’. A non- exhaustive list of such occupations shall be annexed to this Directive.”
Amendment 154 #
Proposal for a directive Article 2 – paragraph 1 i (new) Directive 2004/37/EC Article 18 a – paragraph 7 d (new) (9) in Article 18a, the following paragraph is added: “By ... [twelve months after the date of entry into force of this amending Directive], the Commission shall, after consulting the ACSH, develop guidelines as regards historical occupational exposure to lead, in particular the protection and reduction of exposure for workers whose blood-level levels are above the biological limit value. Those guidelines shall be published on the EU- OSHA website and shall be disseminated in all Member States by the relevant competent authorities.”
Amendment 155 #
Proposal for a directive Article 2 – paragraph 1 j (new) Directive 2004/37/EC Article 18 a – paragraph 7 e (new) (9) in Article 18a, the following paragraph is added: “No later than 31 December 2023, the Commission shall, after consulting the Advisory Committee for Safety and Health at Work (ACSH) and taking into account the existing recommendations from different agencies, stakeholders and the World Health Organization on priority carcinogens, mutagens and reprotoxic substances for which limit values are needed, revise its action plan to achieve occupational exposure limits values for substances, or groups of substances or process-generated substances additional to those referred to in this Directive. No later than 31 December 2024, the Commission shall, taking into account that action plan to achieve limit values for additional substances or group of substances or process-generated substances, the latest developments in scientific knowledge, and after consulting of the ACSH, present a legislative proposal.”
Amendment 156 #
Proposal for a directive Article 2 – paragraph 1 f (new) Directive 2004/37/EC Article 18 a – paragraph 7 a (new) (6) in Article 18a, the following paragraph is added: “By ... [one year after the date of entry into force of this amending Directive], the Commission shall, taking into account the latest developments in scientific knowledge and the opinion of the Committee for Risk Assessment of the European Chemicals Agency established by Regulation (EC) No 1907/2006, and after appropriate consultation of relevant stakeholders, prepare Union guidelines on how the implementation of the limit values referred to in Article 5(4) and 5(4b) are to be adapted in the case of exposure to a combination of substances. Those guidelines shall be published on the EU- OSHA website and shall be disseminated in all Member States by the relevant competent authorities.”
Amendment 157 #
Proposal for a directive Article 2 – paragraph 1 g (new) Directive 2004/37/EC Article 18 a – paragraph 7 b (new) (7) in Article 18a, the following paragraph is added: “By ... [x months after the date of entry into force of this amending directive], the Commission shall review the implementation of this Directive. In the context of that review, its shall consider whether further amendments to this Directive are appropriate, shall assess the feasibility of including endocrine disrupters within the scope of this Directive and, where appropriate, shall present a legislative proposal.”
Amendment 158 #
Proposal for a directive Article 2 – paragraph 1 h (new) Directive 2004/37/EC Article 18 a – paragraph 7 c (new) (8) in Article 18a, the following paragraph is added: “By ... [twelve months after the date of entry into force of this amending Directive], the Commission shall, after consulting the ACSH, develop a definition of ‘carcinogenic occupations’. A non- exhaustive list of such occupations shall be annexed to this Directive.”
Amendment 159 #
Proposal for a directive Article 2 – paragraph 1 i (new) Directive 2004/37/EC Article 18 a – paragraph 7 d (new) (9) in Article 18a, the following paragraph is added: “By ... [twelve months after the date of entry into force of this amending Directive], the Commission shall, after consulting the ACSH, develop guidelines as regards historical occupational exposure to lead, in particular the protection and reduction of exposure for workers whose blood-level levels are above the biological limit value. Those guidelines shall be published on the EU- OSHA website and shall be disseminated in all Member States by the relevant competent authorities.”
Amendment 160 #
Proposal for a directive Article 2 – paragraph 1 h (new) Directive 2004/37/EC Article 18 a – paragraph 7 e (new) In Article 18a, the following paragraph is added: “No later than 1 January 2028, the Commission shall, taking into account the RAC opinion of 2018 and the latest developments in scientific knowledge, start evaluating the feasibility of a further reduction of the limit value for Benzene. No later than 1 January 2030, the Commission shall propose, where appropriate, necessary amendments and modifications related to that substance.”
Amendment 161 #
Proposal for a directive Article 2 – paragraph -1 (new) Directive 2004/37/EC Article 18 a – paragraph 7 d (new) -1. By 31 December 2028, the Commission shall, after consulting the Advisory Committee on Safety and Health at Work, submit a report to the European Parliament and to the Council assessing whether the area of construction and restoration of musical instruments should fall within the scope of this directive. In that report, the Commission shall also list the appropriate limit values applicable to that sector.
Amendment 162 #
Proposal for a directive Article 2 – paragraph 1 Annexes I, III and IIIa to Directive 2004/37/EC are amended in accordance with Annex II to this Directive.
Amendment 163 #
Proposal for a directive Article 3 – paragraph 2 a (new) When transposing the Directive, Member States shall give proper consideration to the special features of crafts that use lead. These sectors shall be subject to different rules under this Directive: the limit values for these professions are a BOEL of 0.1 milligrams per cubic metre (0.1 mg/m³) and a BLV of 35 µg Pb/100 ml blood. It is compulsory for employees to use personal protective equipment and undergo regular blood lead level checks.
Amendment 164 #
Proposal for a directive Annex I Directive 98/24/EC Annex I Amendment 165 #
Proposal for a directive Annex I Directive 98/24/EC Annex I Amendment 166 #
Proposal for a directive Annex I Directive 98/24/EC Annex I Amendment 168 #
Proposal for a directive Annex II – paragraph 1 – introductory part Annexes I, III and IIIa to Directive 2004/37/EC are amended as follows:
Amendment 169 #
Proposal for a directive Annex II – paragraph 1 – introductory part Annexes I, III and IIIa to Directive 2004/37/EC are amended as follows:
Amendment 170 #
Proposal for a directive Annex II – paragraph 1 a (new) 2004/37/EC Annex I – title (-1) in Annex I, the title is amended as follows: "List of substances, preparations and processes (Article 2(a)(ii), 2(b)(ii), 2(ba)(ii))”
Amendment 171 #
Proposal for a directive Annex II – paragraph 1 – point -1 (new) Directive 2004/37/EC Annex I – point 8 a (new) (-1a) in Annex I, the following point is added: “8 a. Work involving exposure to hazardous medicinal products which are 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 172 #
Proposal for a directive Annex II – point -1 a (new) Directive 2004/37/EC Annex I – point 8 a (new) (-1a) in Annex I, the following point is added: “8a. Work involving exposure to hazardous medicinal products.”
Amendment 173 #
Proposal for a directive Annex II – paragraph -1 a (new) Directive 2004/37/EC Annex I – point 8 a (new) (-1a) in Annex I, the following point is added: "8a. Work involving exposure to hazardous medicinal products.”
Amendment 174 #
Proposal for a directive Annex II – paragraph -1 b (new) 2004/37/EC Annex I – point 8 a (new) (-1b) in Annex I, the following point is added: “8a. Work involving exposure to hazardous medicinal products.”
Amendment 175 #
Proposal for a directive Annex II – point 1 Directive 2004/37/EC Annex III – point A – row 31 (1) in Annex III, point A, the row related to inorganic lead and its compounds is replaced by the following:
Amendment 176 #
Proposal for a directive Annex II – point 1 Directive 2004/37/EC Annex III – point A – row 31 (1) in Annex III, point A, the row related to inorganic lead and its compounds is replaced by the following: Limit values EC No CAS 8 hours (3) Short-term (4) Transitional Name of agent (1) No (2)
Amendment 177 #
Proposal for a directive Annex II – point 1 Directive 2004/37/EC Annex III – point A – row 31 (1) in Annex III, point A, the row related to inorganic lead and its compounds is replaced by the following: Limit values EC No CAS 8 hours (3) Short-term (4) Transitional Name of agent (1) No (2)
Amendment 178 #
Proposal for a directive Annex II – point 1 Directive 2004/37/EC Annex III – point A – row 31 (1) in Annex III, point A, the row related to inorganic lead and its compounds is replaced by the following: Limit values EC No CAS 8 hours (3) Short-term (4) Transitional Name of agent (1) No (2)
Amendment 179 #
Proposal for a directive Annex II – point 1 Directive 2004/37/EC Annex III – point A - row 31 (1) in Annex III, point A, the row related to inorganic lead and its compounds is replaced by the following: Limit values EC No CAS 8 hours (3) Short-term (4) Transitional Name of agent (1) No (2)
Amendment 180 #
Proposal for a directive Annex II – point 1 Directive 2004/37/EC Annex III – point A – row 31 (1) in Annex III, point A, the row related to inorganic lead and its compounds is replaced by the following: Limit values EC No CAS 8 hours (3) Short-term (4) Transitional Name of agent (1) No (2)
Amendment 181 #
Proposal for a Directive Annex II – point 1Directive 2004/37/EC Annex III – point A – row 31 (1) in Annex III, point A, the row related to inorganic lead and its compounds is replaced by the following: Limit values EC No CAS 8 hours (3) Short-term (4) Transitional Name of agent (1) No (2)
Amendment 182 #
Proposal for a Directive Annex II – point 2 Directive 2004/37/EC Annex III a Amendment 183 #
Proposal for a directive Annex II – paragraph 1 – point 2 Directive 2004/37/EC ANNEX III a Lead and its i
Amendment 184 #
Proposal for a directive Annex II – paragraph 1 – point 2 Directive (EU) 2022/431of the European Parliament and of the Council Annex III a Amendment 185 #
Proposal for a directive Annex II – paragraph 1 – point 2 2004/37/EC Annex III a Amendment 186 #
Proposal for a directive Annex II – paragraph 1 – point 2 Limit value of 40 µg/100ml of blood for the musical instrument construction and restoration sector until 31 December 2028, provided that the Commission concludes in its report submitted pursuant to Article 18(7d) that the limit value applies to this sector. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 187 #
Proposal for a directive Annex II – paragraph 1 – point 2 Directive 98/24/EC Annex II The binding biological limit value for crafts shall be: 35 μg Pb/100 ml blood.
Amendment 188 #
Proposal for a directive Annex II – paragraph 1 – point 2 Directive 2004/37/EC ANNEX III a Medical surveillance is carried out
Amendment 189 #
Proposal for a directive Annex II – paragraph 1 – point 2 Directive 2004/37/EC Annex III a If the results of the medical surveillance reveal a blood-lead level of a worker greater than the biological limit value due to historical occupational exposure to lead, the employer shall, after receiving the advice of the occupational health-care professional responsible for the health surveillance of that worker, take the necessary measures to ensure a decrease of the worker’s blood-lead level in accordance with the guidelines developed pursuant to Article 18a. A worker may be allowed to continue working with tasks that involve exposure to lead only if that worker is under continuous medical surveillance and if a declining trend of the blood-lead level is established.
Amendment 190 #
Proposal for a directive Annex II – paragraph 1 – point 2 Medical surveillance is carried out if exposure to a concentration of lead in air is greater than 0,0
Amendment 191 #
Proposal for a directive Annex II – paragraph 1 – point 2 Directive 98/24/EC Annex II (1) It is recommended that the blood lead level in women 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 of childbearing age do not exceed the Biological Guidance Value of 4.5
Amendment 192 #
Proposal for a directive Annex II – paragraph 1 – point 2 Directive 2004/37/EC Annex III a (1) It is recommended that the blood lead level in women 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 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 revisited every five years.
Amendment 193 #
Proposal for a directive Annex II – paragraph 1 – point 2 Directive 98/24/EC Annex II (1a) Until 31 December 2028, workers whose blood lead level exceeds the biological limit value of 35 µg Pb/100 ml blood due to exposure that occurred before [the date of transposition of this Directive], but is below 70 µg Pb/100 ml blood, shall undergo regular medical checks. If they demonstrate a declining trend towards the limit value of 35 µg Pb/100 ml blood, employers may allow those workers to continue to carry out work involving lead exposure. After 1 January 2029, workers whose blood lead level exceeds the biological limit value of 15 µg Pb/100 ml blood due to exposure that occurred before [the date of transposition of this Directive], but is below 35 µg Pb/100 ml blood, shall undergo regular medical checks. If they demonstrate a declining trend towards the limit value of 15 µg Pb/100 ml blood, employers may allow those workers to continue to carry out work involving lead exposure.
Amendment 194 #
Proposal for a directive Annex II – paragraph 1 a (new) Directive 2004/37/EG Annex III Amendment 35 #
Proposal for a directive Recital 1 a (new) (1a) The employers' obligations laid down in this Directive should take into account the fact that microenterprises and SMEs, which represent a large majority of enterprises in the Union, have limited financial, technical and human resources. In order to ensure the highest possible protection of workers in all companies, Member States should assess the impact of the implementation of this Directive and the related administrative burden on those enterprises, in order to ensure that they are not disproportionately affected, with specific focus on microenterprises, and to publish the results of such assessments. In doing so, Member States should maintain equal protection for all workers and facilitate compliance of microenterprises and SMEs. Against that background, specific measures, such as financial and administrative support, could help SMEs and microenterprises further to comply with the obligations laid down in Directive 2004/37/EC and progress towards the elimination of risks relating to exposure to carcinogens, mutagens or reprotoxic substances at the workplace, therefore benefitting all workers.
Amendment 36 #
Proposal for a directive Recital 1 a (new) (1a) Article 153 of the Treaty on the Functioning of the European Union states that the Union will support and complement the activities of the Member States in the improvement in particular of the working environment to protect workers’ health and safety. In this regard, the European Parliament resolution of 14 December 20221a recalls that the required level of protection for human health and the environment does not conflict with the preservation of European heritage. __________________ 1a European Parliament resolution of 14 December 2022 on the implementation of the New European Agenda for Culture and the EU Strategy for International Cultural Relations (2022/2047(INI) - P9_TA(2022)0444).
Amendment 37 #
Proposal for a directive Recital 1 b (new) (1b) 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. It is possible, on the basis of the available information, including scientific and technical data, to set limit values for those carcinogens. Exposure to cobalt and cobalt compounds at workplaces may result in dermal sensitisation and sensitisation of the respiratory tract. It is therefore appropriate to urgently establish limit values for both the inhalable and respirable fractions of cobalt and of cobalt compounds in the context of Directive 2004/37/EC.
Amendment 38 #
Proposal for a directive Recital 2 Amendment 39 #
Proposal for a directive Recital 2 (2) Pursuant to its Article 1(3), Directive 98/24/EC is to apply to carcinogens, mutagens and reprotoxic substances at work without prejudice to more stringent or specific provisions set out in Directive 2004/37/EC. To ensure legal certainty and avoid ambiguities and possible confusion over the applicable limit values for lead and its inorganic compounds, those Directives should be amended. This will provide for a revised binding occupational exposure limit value and biological limit value in Directive 2004/37/EC only, more specifically its Annexes III and IIIa containing more specific provisions on reprotoxic substances such as lead and its inorganic compounds. Therefore, the specific provisions setting the occupational exposure limit value for lead and its inorganic compounds in Annex I to Directive 98/24/EC and a biological limit value for lead and its i
Amendment 40 #
Proposal for a directive Recital 3 Amendment 41 #
Proposal for a directive Recital 3 (3) New and revised limit values should be set out in light of available information, including up-to-date scientific evidence and technical data, based on a thorough assessment of the socioeconomic and cultural impact and availability of exposure measurement protocols and techniques at the place of work.
Amendment 42 #
Proposal for a directive Recital 3 (3) New and revised limit values should be set out in light of available information, including up-to-date scientific evidence and technical data, based on a thorough assessment of the socioeconomic and cultural impact and availability of exposure
Amendment 43 #
Proposal for a directive Recital 6 (6) Lead and its inorganic compounds are key occupational reprotoxicants that can affect both fertility and the development of the foetus and meet the criteria for classification as toxic for reproduction (category 1A) in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council and are therefore a reprotoxic substances within the meaning of Article 2, point (ba), of Directive 2004/37/EC. 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 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 level of exposure of workers is reduced to as low a level as is technically possible.
Amendment 44 #
Proposal for a directive Recital 6 (6) Lead and its inorganic compounds are key occupational reprotoxicants that can affect both fertility and the development of the foetus and meet the criteria for classification as toxic for reproduction (category 1A) in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council and are therefore a reprotoxic substances within the meaning of Article 2, point (ba), of Directive 2004/37/EC. Studies show that lead accounts for around half of all occupational exposures to reprotoxic substances.
Amendment 45 #
Proposal for a directive Recital 6 (6) Lead and its inorganic compounds are key occupational reprotoxicants that can affect both fertility and the development of the foetus and meet the criteria for classification as toxic for reproduction (category 1A) in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council and are therefore a reprotoxic substances within the meaning of Article 2, point (ba), of Directive 2004/37/EC. Studies show that lead accounts for around half of all occupational exposure to reprotoxic substances.
Amendment 46 #
Proposal for a directive Recital 6 a (new) (6a) Lead is used in several sectors of strategic importance for reaching the goals set out in the European Green Deal and in Regulation (EU) 2021/11191, such as for example the batteries sector. Advancing the green transition, stimulating the circular economy and maintaining and enhancing the international strategic autonomy in raw materials are all priorities of the Union. __________________ 1 Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (‘European Climate Law’)
Amendment 47 #
Proposal for a directive Recital 6 b (new) (6b) 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.
Amendment 48 #
Proposal for a directive Recital 7 (7) Oral and inhalation exposure are both relevant routes for the uptake of lead and its inorganic compounds into the human body. Taking into account the most recent scientific data and new findings with regard to lead and its inorganic compounds, it is necessary to improve the protection of workers exposed to a potential health risk, by reducing both the occupational exposure and biological limit values for lead. Therefore, a revised biological limit value equal to
Amendment 49 #
Proposal for a directive Recital 7 (7) Oral and inhalation exposure are both relevant routes for the uptake of lead and its inorganic compounds into the human body. Taking into account the most recent scientific data and new findings with regard to lead and its inorganic compounds, it is necessary to improve the protection of workers exposed to a potential health risk, by reducing both the occupational exposure and biological limit values for lead.
Amendment 50 #
Proposal for a directive Recital 7 (7) Oral and inhalation exposure are both relevant routes for the uptake of lead and its inorganic compounds into the human body. Taking into account the most recent scientific data and new findings with regard to lead and its inorganic compounds, it is necessary to improve the protection of workers exposed to a potential health risk, by reducing both the occupational exposure and biological limit values for lead.
Amendment 51 #
Proposal for a directive Recital 7 (7) Oral and inhalation exposure are both relevant routes for the uptake of lead and its inorganic compounds into the human body. Taking into account the most recent scientific data and new findings with regard to lead and its inorganic compounds, it is necessary to improve the protection of workers exposed to a potential health risk, by reducing both the occupational exposure and biological limit values for lead.
Amendment 52 #
Proposal for a directive Recital 7 (7) Oral and inhalation exposure are both relevant routes for the uptake of lead and its inorganic compounds into the
Amendment 53 #
Proposal for a directive Recital 7 a (new) Amendment 54 #
Proposal for a directive Recital 7 a (new) Amendment 55 #
Proposal for a directive Recital 7 a (new) (7a) The need for transition periods arises from the organisational and technological changes and the high costs of production transformation that will arise from the lowering of occupational exposure limit values. In order to ensure an adequate level of protection of workers and monitoring of the limit values, it is necessary to introduce fundamental changes in the production processes, in particular in the production of lead from primary sources, i.e. based on the processing of metal concentrates containing lead and its inorganic compounds.
Amendment 56 #
Proposal for a directive Recital 7 a (new) (7a) When redefining the new limit values, it is also essential to take full account of the special features of the industries concerned, which are sometimes part of high-value cultural and heritage craft sectors, in particular as regards the duration and cost involved in training qualified staff for those industries.
Amendment 57 #
Proposal for a directive Recital 7 b (new) (7b) In its initiative report on a new Union strategic framework on health and safety at work post 2020 (including better protection of workers from exposure to harmful substances, stress at work and repetitive motion injuries) of 9 February 2022, the European Parliament noted that a BLV of 15 µg Pb/100ml (150 µg Pb/L) “does not protect women and especially pregnant women properly” and called for revised exposure limit values for lead and its compounds while ensuring equal protection for all workers regardless of gender.
Amendment 58 #
Proposal for a directive Recital 7 b (new) (7b) In its initiative report on a new Union strategic framework on health and safety at work post 2020 (including better protection of workers from exposure to harmful substances, stress at work and repetitive motion injuries) of 9 February 2022, the European Parliament noted that a BLV of 15 µg Pb/100ml (150 µg Pb/L) “does not protect women and especially pregnant women properly” and called for revised exposure limit values for lead and its compounds while ensuring equal protection for all workers regardless of gender.
Amendment 59 #
Proposal for a directive Recital 7 b (new) (7b) The introduction of a 10-year transition period is also necessary for environmental policy reasons. The inability to comply with the new reduced exposure limit values without a transition period would lead to an uncontrolled expansion of hazardous waste landfills for lead-bearing materials.
Amendment 60 #
Proposal for a directive Recital 7 c (new) (7c) This Directive respects the fundamental rights recognised in the Charter of Fundamental Rights of the European Union, in particular the prohibition of discrimination on the ground of sex and the right to fair and just working conditions provided for, respectively, in Articles 21 and 31 thereof. Moreover, it complies with Principle No 10 of the European Pillar of Social Rights, according to which workers have the right to a healthy, safe and well- adapted work environment. The right of workers to the protection of health and safety at work includes the right to protection from the effects of lead and its inorganic compounds on future generations, such as the negative impacts on the reproductive capacity of men and women, as well as on foetal development. Therefore, a revised BLV equal to 4.5 µg/100ml blood, accompanied by a revised OEL equal to 4 µg Pb/m3 TWA should be established, to ensure the protection of workers who are occupationally exposed to lead, irrespective of their sex. Such a revised BLV is also intended to foster the full participation of women of child- bearing age in economic sectors targeted by the European Green Deal, such as the production of sustainable and circular batteries, in support of the Union’s energy transition.
Amendment 61 #
Proposal for a directive Recital 7 c (new) (7c) This Directive respects the fundamental rights recognised in the Charter of Fundamental Rights of the European Union, in particular the prohibition of discrimination on the ground of sex and the right to fair and just working conditions provided for, respectively, in Articles 21 and 31 thereof. Moreover, it complies with Principle No 10 of the European Pillar of Social Rights, according to which workers have the right to a healthy, safe and well- adapted work environment. The right of workers to the protection of health and safety at work includes the right to protection from the effects of lead and its inorganic compounds on future generations, such as the negative impacts on the reproductive capacity of men and women, as well as on foetal development. Therefore, a revised BLV equal to 4.5 µg/100ml blood, accompanied by a revised OEL equal to 4 µg Pb/m3 TWA should be established, to ensure the protection of workers who are occupationally exposed to lead, irrespective of their sex. Such a revised BLV is also intended to foster the full participation of women of child- bearing age in economic sectors targeted by the European Green Deal, such as the production of sustainable and circular batteries, in support of the Union’s energy transition.
Amendment 62 #
Proposal for a directive Recital 7 c (new) (7c) Financial support from the Commission is necessary to meet the financial demands on Member States to lower the limit values. In addition, a wide- ranging research programme on occupational exposure to lead in the European Union, involving the national research institutes of the Member States responsible for the protection of workers’ health, is necessary to improve knowledge of existing occupational exposure to lead.
Amendment 63 #
Proposal for a directive Recital 7 d (new) (7d) A survey conducted by the Pb REACH consortium in 2020 indicated that P90’s for worker blood lead levels across the EU in the primary metal producers, battery manufacturers and recyclers were 27, 29 and 28 μg Pb/100ml respectively. This information suggests that it will not be technically feasible for many Industrial operations to achieve compliance with a BLV of 4,5μg Pb/dL for all workers due to exposure that has occurred before coming into force of the Directive, without the adoption of appropriate transitional measures, especially if workplaces contain a high number of long service employees. Therefore a transitional BLV of 30 μg Pb/dL will apply to workers already working in the primary or secondary lead industry and showing a BLV higher than 4,5 μg Pb/dL during a transitional period of 5 years from the entry into force of the recast of Directive 2004/37/EC. __________________ https://op.europa.eu/en/publication- detail/-/publication/03b0cc5a-5e22-11ec- 9c6c-01aa75ed71a1/language-en/format- PDF
Amendment 64 #
Proposal for a directive Recital 8 (8) Moreover, to strengthen the health surveillance of workers exposed to lead and its inorganic compounds and thus contribute to the prevention and protection measures to be undertaken by the employer, it is necessary to amend the existing requirements that apply when workers are exposed to
Amendment 65 #
Proposal for a directive Recital 8 (8) Moreover, to strengthen the health surveillance of workers exposed to lead and its inorganic compounds and thus contribute to the prevention and protection measures to be undertaken by the employer, it is necessary to amend the existing requirements that apply when workers are exposed to certain levels of lead and its inorganic compounds. To that end, detailed medical surveillance should be required when exposure to lead and its inorganic compounds exceeds
Amendment 66 #
Proposal for a directive Recital 8 (8) Moreover, to strengthen the health surveillance of workers exposed to lead and its inorganic compounds and thus contribute to the prevention and protection measures to be undertaken by the employer, it is necessary to amend the existing requirements that apply when workers are exposed to certain levels of lead and its inorganic compounds. To that end, detailed medical surveillance should be required when exposure to lead and its inorganic compounds exceeds
Amendment 67 #
Proposal for a directive Recital 8 (8) Moreover, to strengthen the health surveillance of workers exposed to lead and its inorganic compounds and thus contribute to the prevention and protection measures to be undertaken by the employer, in line with the special features of the industry concerned, it is necessary to amend the existing requirements that apply when workers are exposed to certain levels of lead and its inorganic compounds. To that end, detailed medical surveillance should be required when exposure to lead and its inorganic compounds exceeds 0.015 mg/m3 in air (50% of current OEL) or 9 µg/100ml blood (approx. 60% of the current BLV).
Amendment 68 #
Proposal for a directive Recital 8 a (new) (8a) Because of the current use of both a higher OEL and BLV for lead and its inorganic compounds and taking into account historical exposure of workers, health surveillance can show that workers are exceeding the new biological limit value of 15 µg/100ml blood. Given the fact that breaking down existing blood lead level is highly individual and can take several years, these workers should be granted temporary derogation to the new BLV for as long as their lead blood level exceeds the new BLV and be allowed to continue their work activities. To avoid layoffs, employers should relocate these workers to alternative functions with less exposure to lead. During this derogation, workers should be subject to enhanced medical surveillance to ensure a downward trend in their blood lead level. Whenever such relocation to alternative functions is not possible or medical surveillance shows a lack of downward trend, the European Commission should, after consultation with social partners, develop guidelines and recommendations for practical implementation by the Member States to ensure that their social safety net for workers is covering them, for example by supporting the reskilling of these workers.
Amendment 69 #
Proposal for a directive Recital 8 a (new) (8a) Lead and its inorganic compounds are an indispensable component in the construction and restoration of musical instruments, in particular for pipe organs, recognised by UNESCO as Imtangible Cultural Heritage of Humanity. It can therefore be expected that the musical instrument production and restoration sector will have difficulties in conforming, in the short term, to the biological limit value of 15 µg/100ml blood, together with an occupational exposure limit value of 0.03 mg/m³ expressed as a time-weighted average of eight hours. A five-year transitional period should therefore be introduced for that sector, during which a biological limit value of 40 µg/100ml blood and the occupational exposure limit value of 0.05 mg/m³ expressed as a time- weighted average of eight hours should apply.
Amendment 70 #
Proposal for a directive Recital 8 a (new) (8a) Workers who have been occupationally exposed to lead over several years may have accumulated blood-lead levels well above the revised BLV. In the opinion of Committee for Risk Assessment, adverse health effects can already be observed at blood-lead levels that fall within the current BLV of 70 µg Pb/100ml. If possible, employers should move such workers to other tasks in the workplace to ensure the fastest possible decrease in such workers’ blood- lead levels. In the event that granting another job is not possible, more frequent monitoring of blood lead levels should be conducted.
Amendment 71 #
Proposal for a directive Recital 8 a (new) (8a) Workers who have been occupationally exposed to lead over several years may have accumulated blood-lead levels well above the revised BLV. In the opinion of Committee for Risk Assessment, adverse health effects can already be observed at blood-lead levels that fall within the current BLV of 70 µg Pb/100ml. It is not acceptable that such workers continue to be exposed to lead in the workplace. Instead, employers should move such workers to other tasks in the workplace to ensure the fastest possible decrease in such workers’ blood- lead levels.
Amendment 72 #
Proposal for a directive Recital 9 (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.
Amendment 73 #
Proposal for a directive Recital 9 (9) Specific measures should be put in place with regard to risk management, including specific health surveillance that should take into consideration the circumstances of individual workers.
Amendment 74 #
Proposal for a directive Recital 9 (9) Specific measures should be put in place with regard to risk management, including hygiene measures, the use of personal protective equipment and specific health surveillance that should take into consideration the circumstances of individual workers. 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
Amendment 75 #
Proposal for a directive Recital 9 a (new) (9a) Lead accumulates in the bones and is released slowly from there into the circulatory system. Blood lead levels may thus remain high long after exposure to lead has been reduced. If the results of the medical surveillance reveal a blood-lead level of a worker greater than the biological limit value due to historical occupational exposure to lead, the employer should take into account the advice of the occupational health-care professional in implementing any measures required to ensure a decrease of the worker’s blood-lead level, including the possibility of assigning the worker to alternative work where there is no risk of further exposure. A worker may be allowed to continue working with tasks that involve exposure to lead only if that worker is under continuous medical surveillance and if a declining trend of the blood-lead level is established.
Amendment 76 #
Proposal for a directive Recital 9 a (new) Amendment 77 #
Proposal for a directive Recital 9 a (new) (9a) Limit values must only be lowered after close consultation with the industries concerned, taking into account the technical feasibility and impact on the continuation of the activity and employment. A transitional period should also be envisaged, or an exemption for certain sensitive industries in the heritage and craft sectors.
Amendment 78 #
Proposal for a directive Recital 9 b (new) (9b) 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 79 #
Proposal for a directive Recital 9 b (new) (9b) To ensure the implementation of the necessary hygiene measures and to take into account the specific situation of vulnerable workers, the Commission should, in consultation with the ACSH, develop and publish guidelines on the protection and reduction of exposure for workers whose blood-lead levels are above the biological limit value, on the special protection of women of childbearing age and on the hygiene measures necessary to limit the blood lead level of all workers. Those guidelines should be published on the EU-OSHA website and be disseminated in all Member States by the relevant competent authorities.
Amendment 80 #
Proposal for a directive Recital 9 b (new) (9b) The special features of the industries concerned, in particular those linked to crafts and heritage, should be taken into account in order to assess the technical feasibility of these measures, and exemptions may, where necessary, be put in place.
Amendment 81 #
Proposal for a directive Recital 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.
Amendment 82 #
Proposal for a directive Recital 9 d (new) (9d) Union-wide data from work- related health problems due to lead exposure are often lacking, unreliable or insufficient. The European Commission should develop guidelines and recommendations for data collection by the Member States to improve the reporting and exposures registries.
Amendment 83 #
Proposal for a directive Recital 12 (12) Diisocyanates can be absorbed through the skin and exposure to diisocyanates at the place of work may also result in dermal sensitisation and sensitisation of the respiratory tract. It is therefore appropriate to establish an occupational exposure limit of 6 µg NCO/m³ and a short-term exposure limit of 12 µg NCO/m³ for this group of chemical agents and to assign a skin, dermal and respiratory sensitisation notation to it.
Amendment 84 #
Proposal for a directive Recital 12 (12) Diisocyanates can be absorbed through the skin and exposure to diisocyanates at the place of work may also result in dermal sensitisation and sensitisation of the respiratory tract. It is therefore appropriate to establish an occupational exposure limit of 6 µg NCO/m³ and a short-term exposure limit of 12 µg NCO/m³ for this group of chemical agents and to assign a skin, dermal and respiratory sensitisation notation to it.
Amendment 85 #
Proposal for a directive Recital 12 (12) Diisocyanates can be absorbed through the skin and exposure to diisocyanates at the place of work may also result in dermal sensitisation and sensitisation of the respiratory tract. It is therefore appropriate to establish an occupational exposure limit of 6 µg NCO/m³ and a short-term exposure limit of 12 µg NCO/m³ for this group of chemical agents and to assign a skin, dermal and respiratory sensitisation notation to it.
Amendment 86 #
Proposal for a directive Recital 13 (13) It may be difficult to comply with an occupational exposure limit equal to 6 µg NCO/m³ for diisocyanates, accompanied by an associated short-term exposure limit equal to 12 µg NCO/m³. This difficulty is due to technical measurement feasibility issues and the time needed to implement risk management measures in particular in downstream sectors involving activities such as applications of paints, work with lead metal, demolition, repair and scrap management, other waste management and soil remediation. Therefore, a transitional value of 10 µg NCO/m³ with an associated short-
Amendment 87 #
Proposal for a directive Recital 13 (13) It may be difficult to comply with an occupational exposure limit equal to 6 µg NCO/m³ for diisocyanates, accompanied by an associated short-term exposure limit equal to 12 µg NCO/m³. This difficulty is due to technical measurement feasibility issues and the time needed to implement risk management measures in particular in downstream sectors involving activities such as applications of paints, work with lead metal, demolition, repair and scrap management, other waste management and soil remediation. Therefore, a transitional value of 10 µg NCO/m³ with an associated short-
Amendment 88 #
Proposal for a directive Recital 13 (13) It may be difficult to comply with an occupational exposure limit equal to 6 µg NCO/m³ for diisocyanates, accompanied by an associated short-term exposure limit equal to 12 µg NCO/m³. This difficulty is due to technical measurement feasibility issues and the time needed to implement risk management measures in particular in downstream sectors involving activities such as applications of paints, work with lead metal, demolition, repair and scrap management, other waste management and soil remediation. Therefore, a transitional value of 10 µg NCO/m³ with an associated short-
Amendment 89 #
Proposal for a directive Recital 13 (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. Th
Amendment 90 #
Proposal for a directive Recital 13 a (new) (13a) Craftspeople using lead for restoration or building work (organ builders and other instrument makers, stained glass artists, roof restorers, etc.) should be subject to different rules under this Directive in light of the feasibility of the applicable levels and the sustainability of the sectors concerned. The revision of the limit values and the required level of protection for workers’ health and safety must not lead to the disappearance of these activities, which are crucial for preserving heritage, and for preserving skills and the jobs intrinsically linked to them. A fair balance must be achieved in order to ensure the safety of workers through the use of personal protective equipment and regular blood lead level checks, while ensuring the preservation of these crafts.
Amendment 91 #
Proposal for a directive Recital 13 a (new) (13a) No later than 1 January 2029, the Commission should launch the process of evaluating the need to modify the binding limit values for diisocyanates and, where appropriate, after consulting the ACSH, should propose necessary amendments and modifications related to that group of substances in Annex I without delay.
Amendment 92 #
Proposal for a directive Recital 14 (14) The Commission has consulted the Committee for Risk Assessment) which provided opinions on both substances. The Commission has carried out a two-stage consultation of management and labour at Union level in accordance with Article 154 of the Treaty. It has also consulted the Advisory Committee on Safety and Health at Work, which adopted opinions regarding the revision of the limit values for lead and its inorganic compounds93 and establishment of an occupational limit value for diisocyanates94, with recommendations for appropriate notations and a review of the limit values for diisocyanates starting in 2029. __________________ 93 See footnote 8.
Amendment 93 #
Proposal for a directive Recital 15 (15) The limit values established in this Directive
Amendment 94 #
Proposal for a directive Recital 15 a (new) (15a) The central aim of this legislation is to ensure a comprehensive level of protection for workers and also to protect the cultural heritage of the European Union. Therefore, a sectoral exemption for the occupational substance lead should be introduced for activities, which are essential for cultural activities in Europe. It should be regularly reviewed whether these regulations are still necessary for the preservation of Europe's cultural heritage.
Amendment 95 #
Proposal for a directive Recital 15 a (new) (15a) Following the adoption of the Commission Delegated Regulation (EU) 2023/7071a and the introduction of a new hazard class for endocrine disruptors, such substances should be covered by Union health and safety law. It is therefore necessary to consider extending the scope of Directive 2004/37/EC to endocrine disruptors, which have the ability to interfere with the hormonal system and can therefore induce adverse health effects. __________________ 1a Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures (OJ L 93, 31.3.2023, p. 7)
Amendment 96 #
Proposal for a directive Recital 15 a (new) Amendment 97 #
Proposal for a directive Recital 15 a (new) (15a) Following the adoption of the Commission Delegated Regulation (EU) 2023/7071a and the introduction of a new hazard class for endocrine disruptors, such substances should be covered by Union health and safety law. It is therefore necessary to consider extending the scope of Directive 2004/37/EC to endocrine disruptors, which have the ability to interfere with the hormonal system and can therefore induce adverse health effects. __________________ 1a Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures (OJ L 93, 31.3.2023, p. 7)
Amendment 98 #
Proposal for a directive Recital 15 a (new) (15a) 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 99 #
Proposal for a directive Recital 15 b (new) source: 749.282
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