Awaiting committee decision
2018/0081(COD) Protection of workers from the risks related to exposure to carcinogens or mutagens at work: limit values
Lead committee dossier: EMPL/8/12691
Legal Basis TFEU 153-p1, TFEU 153-p2
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | EMPL | AGEA Laura (EFD) | ULVSKOG Marita (S&D), CALVET CHAMBON Enrique (ALDE), DELLI Karima (Verts/ALE), MÉLIN Joëlle (ENF) |
| Opinion | ENVI | MÉLIN Joëlle (ENF) | |
| Opinion | JURI | MAŠTÁLKA Jiří (GUE/NGL) |
Legal Basis TFEU 153-p1, TFEU 153-p2
Activites
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2018/11/20
Vote scheduled in committee, 1st reading/single reading
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2018/04/16
Committee referral announced in Parliament, 1st reading/single reading
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2018/04/05
Legislative proposal published
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COM(2018)0171
summary
PURPOSE: to improve the protection of workers against the risks related to exposure to carcinogens or mutagens at work. PROPOSED ACT: Directive of the European Parliament and of the Council. ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: the European Pillar on Social Rights - jointly proclaimed by the European Parliament, the Council and the Commission on 17 November 2017 at the Social Summit in Gothenburg - identifies workers' right to healthy, safe and well adapted work environment, which includes protection from carcinogens, as one of the main principles. Cancer is the main work-related health problem in the EU-28, causing almost as much damage to workers' lives and health as the two following combined (musculoskeletal disorders and circulatory diseases). The European Commission took steps to address these issues by adopting two legislative proposals updating the Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. These two proposals addressed 20 carcinogens. The first of these proposals was adopted by the co-legislators on 12 December 2017 as Directive (EU) 2017/2398 and the second is currently subject to discussion within the Council and the Parliament. The objective of this third proposal is to improve the level of health protection of workers by establishing limit values for five additional carcinogens, with comments in Annex III to Directive 2004/37/EC. The proposal is in line with the Commission's Communication ‘safer and healthier work for all’. IMPACT ASSESSMENT: the measures resulting from the opinions of the Advisory Committee on Safety and Health at Work (ACSH) have been selected as the preferred measures for all chemical agents covered by the proposal, including the transitional periods for three substances: cadmium (7 years), beryllium (5 years) and arsenic acid (2 years). As regards the impact on workers, the retained policy option for the five substances under consideration should result in benefits in terms of avoided work-related ill-health and cancer cases and related monetised health benefits. According to estimates, the adoption of the proposal would imply that in the longer term over 1 000 000 EU workers would benefit from improved prevention and protection in relation to occupational exposure to carcinogens and mutagens substances, that can be at the origin of different types of cancers, e.g., lung, bladder, kidney, nasopharyngeal and others, and it would prevent 22 000 cases of ill-health CONTENT: the European Commission proposes to add five new substances to Annex III of Directive 2004/37/EC extending the list of binding EU limit values, namely: cadmium and its inorganic compounds under the scope of the Directive; beryllium and inorganic beryllium compounds under the scope of the Directive; arsenic acid and its salts, as well as inorganic arsenic compounds under the scope of the Directive; formaldehyde (5) 4,4'-Methylene-bis(2-chloroaniline) ("MOCA"). Limit values address the inhalation route of exposure, describing a maximum airborne concentration level for a given chemical agent above which workers should not be exposed, on average, during a defined time period. These measures are supplemented by a skin notation for MOCA, a notation for skin sensitisation for formaldehyde, and a notation for skin and respiratory sensitisation for beryllium and its inorganic compounds.
- DG {'url': 'http://ec.europa.eu/info/departments/employment-social-affairs-and-inclusion_en', 'title': 'Employment, Social Affairs and Inclusion'}, THYSSEN Marianne
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COM(2018)0171
summary
Documents
- Legislative proposal published: COM(2018)0171
| Amendments | Dossier |
| 128 |
2018/0081(COD)
2018/09/06
ENVI
28 amendments...
Amendment 1 #
Proposal for a directive Recital 1 (1) Principle 10 of the European Pillar of Social Rights43, proclaimed at Gothenburg on 17 November 2017, provides that every worker has the right to healthy, safe and well-adapted work environment. The right to a high level of protection of the health and safety at work, as well as to a working environment adapted to the professional needs of workers and which enables them to prolong their participation in the labour market in
Amendment 10 #
Proposal for a directive Recital 12 (12) With regard to cadmium, a limit value of 0,001 mg/m3 may be difficult to be complied with in some sectors in the short term. A transitional period of
Amendment 11 #
Proposal for a directive Recital 12 (12) With regard to cadmium, a limit value of 0,001 mg/m3 may be difficult to be complied with in some sectors in the short term. A transitional period of
Amendment 12 #
Proposal for a directive Recital 12 (12) With regard to cadmium, a limit value of 0,001 mg/m3 may be difficult to be complied with in some sectors in the short term. A transitional period of seven years should therefore be introduced during which the limit value 0,004 mg/m3 should apply
Amendment 13 #
Proposal for a directive Recital 13 (13) Beryllium and most inorganic beryllium compounds meet the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and (category 1) as designated by the International Agency for Research on Cancer, and are therefore carcinogens within the meaning of Directive 2004/37/EC. In addition to carcinogenic properties beryllium is known to provoke chronic beryllium disease (CBD) and beryllium sensitisation (BeS). It is possible, on the basis of the available information, including scientific and technical data, to set a limit value for that group of carcinogens. It is therefore appropriate to establish a limit value for beryllium and inorganic beryllium compounds under the scope of Directive2004/37/EC and to assign a notation for skin and respiratory sensitisation.
Amendment 14 #
Proposal for a directive Recital 14 (14) With regard to beryllium, a limit value of 0,0002 mg/m3 may be difficult to be complied with in some sectors in the short term. A transitional period of five years should therefore be introduced during which the limit value of 0,0006 mg/m3should apply
Amendment 15 #
Proposal for a directive Recital 17 (17) Formaldehyde meets the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and is therefore a carcinogen within the meaning of Directive 2004/37/EC. It is a local acting genotoxic carcinogen.
Amendment 16 #
Proposal for a directive Recital 17 a (new) (17a) Formaldehyde is routinely used in European healthcare centres for the standardised fixation of tissue samples; a pathologist’s diagnosis of a variety of diseases, including cancer, is based on the recognition of microscopic traces in tissue fixed in formaldehyde.
Amendment 17 #
Proposal for a directive Recital 17 b (new) (17b) Until such time as other fixatives are available in the EU that are able to perform the crucial role that formaldehyde plays in patient care, the healthcare sector should be exempt from any restrictions on formaldehyde use that could give rise to multiple errors in diagnosis, putting countless European patients at risk.
Amendment 18 #
Proposal for a directive Recital 17 c (new) (17c) Healthcare centres in the EU should take all appropriate measures to keep formaldehyde exposure among their staff within safe limits.
Amendment 19 #
Proposal for a directive Recital 21 (21) The limit values set out in this Directive are to be kept under review to ensure consistency with Regulation (EC) No 1907/2006 of the European Parliament and of the Council50 , in particular to take account of the interaction between limit values set out under Directive 2004/37/EC and derived no effect levels for hazardous chemicals under that Regulation in order to protect workers effectively. Systematic, regular and documented revisions must be implemented on the limit values of existing agents. __________________ 50 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the
Amendment 2 #
Proposal for a directive Recital 2 (2) Directive 2004/37/EC of the European Parliament and of the Council44 aims to protect workers against risks to their health and safety from exposure to carcinogens or mutagens at the workplace.
Amendment 20 #
Proposal for a directive Recital 22 Amendment 21 #
Proposal for a directive Recital 23 (23) In implementing this Directive, while bearing in mind at all times that worker safety is paramount, Member States should avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings. Member States are therefore invited to assess the impact of their transposition act on SMEs in order to make sure that SMEs are not disproportionately affected, with specific attention for micro-enterprises and for administrative burden, and to publish the results of such assessments.
Amendment 22 #
Proposal for a directive Recital 23 (23) In implementing this Directive Member States should avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings. Member States are therefore invited to assess the impact of their transposition act
Amendment 23 #
Proposal for a directive Recital 23 (23) In implementing this Directive, Member States should avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings and healthcare facilities. Member States are therefore invited to assess the impact of their transposition act on SMEs in order to make sure that SMEs are not disproportionately affected
Amendment 24 #
Proposal for a directive Recital 23 (23) In implementing this Directive Member States should avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings. Member States are therefore invited to assess the impact of their transposition act on SMEs in order to make sure that SMEs are not disproportionately affected, with specific attention for micro-enterprises and for administrative burden, and to publish the results of such assessments. Public health must nevertheless take priority over other considerations, in particular financial considerations, in the assessment of the constraints imposed on undertakings by national rules on exposure to carcinogens and mutagens.
Amendment 25 #
Proposal for a directive Annex – paragraph 1 – table – column 11 – row 2 Transitional measures 0,004 mg/m3 until xx yyyy 202z [
Amendment 26 #
Proposal for a directive Annex – paragraph 1 - table – column 4 – row 4 mg/m3 0,01 (inhalable fraction)
Amendment 28 #
Proposal for a directive Annex – paragraph 1 - table Amendment 3 #
Proposal for a directive Recital 3 (3) Occupational exposure limit values are part of risk management under Directive 2004/37/EC. Compliance with those limit values is without prejudice to
Amendment 4 #
Proposal for a directive Recital 3 (3) Occupational exposure limit values are part of risk management under Directive 2004/37/EC. Compliance with those limit values is without prejudice to other obligations of employers pursuant to Directive 2004/37/EC, such as the reduction of the use of carcinogens and mutagens at the workplace, the prevention or reduction of workers’ exposure to carcinogens or mutagens and the measures which should be implemented to that
Amendment 5 #
Proposal for a directive Recital 4 (4) For most carcinogens and mutagens, it is not scientifically possible to identify levels below which exposure would not lead to adverse effects. Therefore, actions to phase down, as soon as possible, all relevant agents classified under categories 1A and 1B in accordance with Regulation (EC) 1272/2008, is necessary. While setting the limit values at the workplace in relation to carcinogens and mutagens pursuant to Directive 2004/37/EC does not completely eliminate risks to the health and safety of workers arising from exposure at work (residual risk), it nonetheless contributes to a significant reduction of risks arising from such exposure in the stepwise and goal- setting approach pursuant to Directive 2004/37/EC. For other carcinogens and mutagens, it may be scientifically possible to identify levels below which exposure is not expected to lead to adverse effects.
Amendment 6 #
Proposal for a directive Recital 4 (4) For most carcinogens and mutagens, it is not scientifically possible to identify levels below which exposure would not lead to adverse effects. While setting the limit values at the workplace in relation to carcinogens and mutagens pursuant to Directive 2004/37/EC does not completely eliminate risks to the health and safety of workers arising from exposure at work (residual risk), it nonetheless contributes to a significant reduction of risks arising from such exposure in the stepwise and goal-setting approach pursuant to Directive 2004/37/EC. For other carcinogens and mutagens, it may be scientifically possible to identify levels below which exposure is not expected to lead to adverse effects. Scientific research to determine the exact value of these limits should be encouraged.
Amendment 7 #
Proposal for a directive Recital 6 (6) This Directive strengthens the protection of workers’ health and safety at
Amendment 8 #
Proposal for a directive Recital 6 (6) This Directive strengthens the protection of workers’ health and safety at their workplace. New limit values should be set out in Directive 2004/37/EC in the light of available information, including new scientific and technical data and evidence-based best practices, techniques and protocols for exposure level measurement at the workplace. That information should, if possible, include data on residual risks to the health of workers, recommendations of the Scientific Committee on Occupational Exposure
Amendment 9 #
Proposal for a directive Recital 8 (8) The assessment of health effects of carcinogens subject to this proposal was based on the relevant scientific expertise from the SCOEL
source: 627.037
2018/09/11
JURI
26 amendments...
Amendment 13 #
Proposal for a directive Recital 1 (1)
Amendment 14 #
Proposal for a directive Recital 1 a (new) (1a) In order to achieve a European social triple A, the EU is seeking to ensure the effective prevention of serious workplace accidents and occupational diseases and improve the health of workers throughout their entire working life. Measures to achieve these objectives will ensure compliance with the provisions of the Charter of Fundamental Rights of the European Union, in particular those regarding the right to life and the right to fair and just working conditions, while at the same time improving productivity and competitiveness at EU level.
Amendment 15 #
Proposal for a directive Recital 2 (2) Directive 2004/37/EC of the European Parliament and of the Council
Amendment 16 #
Proposal for a directive Recital 3 a (new) (3a) Limit values will be verified and, as appropriate, updated periodically in line with the latest scientific studies.
Amendment 17 #
Proposal for a directive Recital 4 (4) For most carcinogens and mutagens, it is not scientifically possible to identify levels below which exposure would not lead to adverse effects. While setting the limit values at the workplace in relation to carcinogens and mutagens pursuant to Directive 2004/37/EC does not completely eliminate risks to the health and safety of workers arising from exposure at work (residual risk), it nonetheless contributes to a significant reduction of risks arising from such exposure in the stepwise and goal-setting approach pursuant to Directive 2004/37/EC. For other carcinogens and mutagens, it may be scientifically possible to identify levels below which exposure is not expected to lead to adverse effects. For this purpose it is necessary to engage in further research to determine with the input of the scientific community, such levels with utmost urgency.
Amendment 18 #
Proposal for a directive Recital 4 (4) For most carcinogens and mutagens, it is not scientifically possible to identify levels below which exposure would not lead to adverse effects. While setting the limit values at the workplace in relation to carcinogens and mutagens pursuant to Directive 2004/37/EC does not completely eliminate risks to the health and safety of workers arising from exposure at
Amendment 19 #
Proposal for a directive Recital 6 (6) Th
Amendment 20 #
Proposal for a directive Recital 7 (7) It is also necessary, in the light of scientific data, to consider other absorption pathways than inhalation of all carcinogens and mutagens, including observations regarding the possibility of uptake through the skin
Amendment 21 #
Proposal for a directive Recital 9 a (new) (9a) It is anticipated that setting EU limits for exposure to carcinogens and mutagens at the workplace will contribute effectively to the prevention of significant health problems and cancer and, in addition, improve the quality of life and well-being of workers and those in their immediate circle, prolonging working life, leading to increased productivity and competitiveness in the EU and helping to ensure a level playing field for businesses in the EU.
Amendment 22 #
Proposal for a directive Recital 12 (12) With regard to cadmium, a limit value of 0,001 mg/m3 may be difficult to be complied with in some sectors in the short term. A transitional period of
Amendment 23 #
Proposal for a directive Recital 12 (12) With regard to cadmium, a limit value of 0,001 mg/m3 may be difficult to be complied with in some sectors in the short term. A transitional period of
Amendment 24 #
Proposal for a directive Recital 14 (14) With regard to beryllium, a limit value of 0,0002 mg/m3 may be difficult to be complied with in some sectors in the short term. A transitional period of f
Amendment 25 #
Proposal for a directive Recital 14 (14) With regard to beryllium, a limit value of 0,0002 mg/m3 may be difficult to be complied with in some sectors in the short term. A transitional period of
Amendment 26 #
Proposal for a directive Recital 18 a (new) (18a) There is sufficient evidence of the carcinogenicity of diesel engine exhaust emissions. Diesel engine exhaust has been classified by the International Agency for Research on Cancer as carcinogenic (Group 1) to humans in 2012, based on sufficient evidence that exposure is associated with an increased risk for lung cancer. New diesel engine technology has changed the quality and quantity of diesel emissions and the associated cancer risks have been reduced but not eliminated. Due to the long transition time to switch from old to new diesel technology, a concomitant exposure to exhaust emissions from old and new diesel engines is expected to occur at work for the many years to come. Diesel engine exhaust emissions are process-generated and consequently they are not subject to classification in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council. On the basis of available information, including scientific and technical data, a limit value for diesel engine exhaust emissions should be established. It is therefore appropriate to include work involving exposure to diesel engine exhaust emissions in Annex I and to establish a limit value for diesel engine exhaust emissions in Annex III to Directive 2004/37/EC. The entries in Annex I and Annex III to that Directive should cover fumes from all types of diesel engine and are thus irrespective of whether the exhaust emissions are from old or new diesel engines. Elemental carbon is known as the relevant marker of exposure to diesel engine exhaust emissions.
Amendment 27 #
Proposal for a directive Recital 18 b (new) (18b) Certain polycyclic aromatic hydrocarbons (PAHs) mixtures meet the criteria for classification as carcinogenic in accordance with Regulation (EC) No 1272/2008 and therefore are carcinogens as defined in Directive 2004/37/EC. Exposure to such mixtures may occur during work involving burning processes, such as from combustion engine exhaust, and high temperature combustion processes, among others. The existing entry 2 in Annex I to that Directive should therefore be extended to also cover other occupational exposure situations during which workers are exposed to these substances and their mixtures. In addition, on the basis of available information, including scientific and technical data, it is appropriate to establish a limit value for PAHs mixtures with benzo[a]pyrene as indicator in part A.
Amendment 28 #
Proposal for a directive Recital 20 a (new) (20a) Similarly, a long-term assessment of the added value of implementing this directive indicates that it will improve working conditions for over 1 000 000 workers in the EU and prevent more than 22 000 occupational illnesses.
Amendment 29 #
Proposal for a directive Recital 21 (21) The limit values set out in this Directive are to be verified and kept under periodic review to ensure consistency with Regulation (EC) No 1907/2006 of the European Parliament and of the Council50, in particular to take account of the interaction between limit values set out under Directive 2004/37/EC and derived no effect levels for hazardous chemicals under that Regulation in order to protect workers effectively. __________________ 50 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
Amendment 30 #
Proposal for a directive Recital 21 a (new) (21a) Compliance with the transitional periods laid down in this Directive allows for the adoption of appropriate measures to anticipate any new developments and plan investments so as to avoid any adverse effects for businesses or workers. In the case of SMEs, for example, transitional periods regarding certain substances will help them address any specific technical challenges and plan investments sufficiently well in advance.
Amendment 31 #
Proposal for a directive Annex – paragraph -1 (new) Directive 2004/37/EC Annex I – point 5 a (new) In Annex I of Directive 2004/37/EC the following point is added: “5a. Work involving exposure to diesel engine exhaust emissions”
Amendment 32 #
Proposal for a directive Annex – paragraph -1 a (new) Directive 2004/37/EC Annex I – point 5 b (new) In Annex I of Directive 2004/37/EC, the following point is added: “5b. Work involving exposure to polycyclic aromatic hydrocarbons present in coal soot, coal tar or coal pitch and work involving exposure to carcinogenic polycyclic aromatic hydrocarbons, in particular in any burning process, such as from combustion engine exhaust, and high temperature combustion processes, among others.”
Amendment 33 #
Proposal for a directive Annex – paragraph 1 Directive 2004/37/EC Annex III – point A – table – column “Transitional measures” – row 1 Limit value 0,004 mg/m3 until xx yyyy 202z [
Amendment 34 #
Proposal for a directive Annex – paragraph 1 Directive 2004/37/EC Annex III – point A – table – column “Transitional measures” – row 2 Limit value 0,0006 mg/m3 until xx yyyy
Amendment 35 #
Proposal for a directive Annex – paragraph 1 Directive 2004/37/EC Annex III – point A – table – column “Name of agent” – row 5 a (new) Polycyclic aromatic hydrocarbons mixtures containing benzo[a]pyrene which are carcinogens within the meaning of the Directive
Amendment 36 #
Proposal for a directive Annex – paragraph 1 Directive 2004/37/EC Annex III – point A – table – column “Limit values” – column “8 hours” – column “mg/m3” – row 5 a (new) 0,0000710a ________________ 10a benzo[a]pyrene as a marker of total PAH concentration
Amendment 37 #
Proposal for a directive Annex – paragraph 1 Directive 2004/37/EC Annex III – point A – table – column “Name of agent” – row 5 b (new) Diesel engine exhaust emissions
Amendment 38 #
Proposal for a directive Annex – paragraph 1 Directive 2004/37/EC Annex III – point A – table – column “Limit values” – column “8 hours” – column “mg/m3” – row 5 b (new) 0,00001110b ________________ 10b measured as elemental carbon
source: 627.671
2018/09/24
EMPL
74 amendments...
Amendment 26 #
Proposal for a directive Recital 1 (1) Principle 10 of the European Pillar of Social Rights43, proclaimed at Gothenburg on 17 November 2017, provides that every worker has the right to healthy, safe and well-adapted work environment. The right to a high level of protection of the health and safety at work, as well as to a working environment adapted to the professional needs of workers
Amendment 27 #
Proposal for a directive Recital 1 (1) Principle 10 of the European Pillar of Social Rights43
Amendment 28 #
Proposal for a directive Recital 1 a (new) (1a) Delivering on the European Pillar of Social Rights is a shared political commitment and responsibility. The European Pillar of Social Rights should be implemented at both Union level and Member State level within their respective competences, taking due account of different socio-economic environments and the diversity of national systems, including the role of social partners, and in accordance with the principles of subsidiarity and proportionality.
Amendment 29 #
Proposal for a directive Recital 1 a (new) (1a) The professional environment of workers wholly interacts with the non- professional environment and general public-health considerations.
Amendment 30 #
Proposal for a directive Recital 2 (2) Directive 2004/37/EC of the European Parliament and of the Council44 aims to protect workers against risks to their health and safety from exposure to carcinogens or mutagens at the workplace. A consistent level of protection from the risks related to carcinogens and mutagens is provided for in Directive 2004/37/EC by a framework of general principles to enable Member States to ensure the consistent application of the minimum requirements. Binding occupational exposure limit values established on the basis of available information, including scientific and technical data, economic feasibility, a thorough assessment of the socioeconomic impact and availability of exposure measurement protocols and techniques at the workplace, are important components of the general arrangements for the protection of workers established by Directive 2004/37/EC. The minimum requirements provided for in Directive 2004/37/EC aim to protect workers at Union level.
Amendment 31 #
Proposal for a directive Recital 2 (2) Directive 2004/37/EC of the European Parliament and of the Council44 aims to protect workers against risks to their health and safety from exposure to carcinogens or mutagens at the workplace. A consistent level of protection from the risks related to carcinogens and mutagens is provided for in Directive 2004/37/EC by a framework of general principles to enable Member States to ensure the consistent application of the minimum requirements. Binding occupational exposure limit values need to be evidence-based, proportionate and measurable, being established on the basis of available information, including updated scientific and technical data, economic feasibility of implementation and compliance, a thorough assessment of the socioeconomic impact and availability of exposure measurement protocols and techniques at the workplace, are important components of the general arrangements for the protection of workers established by Directive 2004/37/EC. The minimum requirements provided for in Directive
Amendment 32 #
Proposal for a directive Recital 2 (2) Directive 2004/37/EC of the European Parliament and of the Council44 aims to protect workers against risks to their health and safety from exposure to carcinogens or mutagens at the workplace. A
Amendment 33 #
Proposal for a directive Recital 2 a (new) (2a) Directive 2004/37/EC of the European Parliament and of the Council aims to cover substances or mixtures which meet the criteria for classification as a category 1A or 1B carcinogen and/or mutagen set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council as well as substances, mixtures or processes referred to in Annex I to this Directive. The substances which meet the criteria for classification as a category 1A or 1B carcinogen or mutagen set out in Annex I to Regulation (EC) No 1272/2008 are those with a harmonised classification or a self-classification notified to the European Chemicals Agency (ECHA). Those substances are listed in the public Classification and Labelling Inventory maintained by ECHA. Substances classified by IARC as carcinogens category 1 or 2A are also deemed to meet the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council 1a . __________________ 1a Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
Amendment 34 #
Proposal for a directive Recital 2 a (new) (2a) Directive 2004/37/EC of the European Parliament and of the council aims to cover substances or mixtures which meet the criteria for classification as a category 1A or 1B carcinogen and/or mutagen set out in annex I to Regulation (EC) N° 1272/2008 of the European Parliament and of the Council (1) as well as substances, mixtures or process referred to in annex I to this Directive. The substances which meet the criteria for classification as a category 1A or 1B carcinogen or mutagen set out in Annex I to Regulation (EC) N° 1272/2008 are those with an harmonised classification or a self-classification notified to the European Chemicals Agency (ECHA). They are listed in the public Classification and Labelling Inventory maintained by ECHA. Substances classified by IARC as carcinogens category 1or 2A are also deemed to meet the criteria for classification as a category 1A or 1B carcinogen set out in annex I to Regulation (EC) N° 1272/2008 of the European Parliament and of the Council1a. __________________ 1a Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
Amendment 35 #
Proposal for a directive Recital 2 a (new) (2a) In order to take into account technical progress and scientific developments after the adoption of this Directive, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the modification of the limit values established in Annex III to Directive 2004/37/EC.
Amendment 36 #
Proposal for a directive Recital 2 a (new) (2a) Exposure limits should always take into account the feasibility of implementation and compliance, particularly for SMEs and microenterprises.
Amendment 37 #
Proposal for a directive Recital 2 b (new) (2b) SMEs and microenterprises representing the large majority of enterprises in the Union, have limited financial, technical and human resources, these raising concerns on its capacity to comply with stricter legislation, while maintaining equal protection levels for workers of SMEs and microenterprises, compliance for these companies should become simpler and less costly by specific support measures, these including financial incentives and digital tools; in these regard social partners shall exchange best practices.
Amendment 38 #
Proposal for a directive Recital 2 b (new) (2b) It is necessary in order to reduce exposure and achieve better compliance with established exposure limits, particularly for SMEs, to set exposure limit values that are feasible and can be measured in the workplace in all sectors rather than setting exposure limit values at levels that are not feasible, cannot be measured in the workplace and will not improve the level of compliance and workers' protection.
Amendment 39 #
Proposal for a directive Recital 2 c (new) (2c) Wide differences in the Member States regarding the setting of limit values for the carcinogens and mutagens persist which leads to different workers protection levels across the Union and also distorts competition.
Amendment 40 #
Proposal for a directive Recital 3 (3) Occupational exposure limit values are part of risk management under Directive 2004/37/EC. The limit values should be revised regularly in accordance with the precautionary principle, the principle of the protection of workers and in light of available scientific and technical data concerning carcinogens and mutagens. Consideration should also be given to improving measurement techniques, risk management measures, and other relevant factors. Compliance with those limit values is without prejudice to other obligations of employers pursuant to Directive 2004/37/EC, such as the reduction of the use of carcinogens and mutagens at the workplace, the prevention or reduction of workers’ exposure to carcinogens or mutagens and the measures which should be implemented to that effect. Those measures should include, as far as it is technically possible, the replacement of the carcinogen or mutagen by a substance, mixture or process which is not dangerous or is less dangerous to workers’ health, the use of a closed system or other measures aiming to reduce the level of workers’ exposure. In that context, it is essential to take the precautionary principle into account where there are uncertainties.
Amendment 41 #
Proposal for a directive Recital 4 a (new) Amendment 42 #
Proposal for a directive Recital 4 a (new) (4a) There is sufficient evidence of the carcinogenicity of diesel engine exhaust emissions arising from the combustion of diesel fuel in compression ignition engines. Diesel engine exhaust emissions are process-generated and therefore they are not subject to classification in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council1 a. The ACSH has agreed to add traditional diesel engine exhaust emissions to Annex I to Directive 2004/37/EC and has requested further studies on the scientific and technical aspects of new engine models. Diesel engine exhaust has been classified by the International Agency for Research on Cancer (IARC) as carcinogenic to humans (IARC category 1) and the IARC has specified that while the amount of particulates and chemicals are reduced in the newer types of diesel engines, it is not yet clear how the quantitative and qualitative changes will translate into altered health effects. The IARC has also specified that it is common to use elemental carbon, which makes up a significant proportion of those emissions, as a marker of exposure. Given the above and the number of workers exposed, it is appropriate to include work involving exposure to diesel engine exhaust emissions in Annex I to Directive 2004/37/EC and to establish a limit value for diesel engine exhaust emissions calculated on elemental carbon in Part A of Annex III thereto. The Commission should review that limit value by using the most up-to-date scientific and socio- economic data. The entries in Annex I and Annex III to Directive 2004/37/EC should cover exhaust from all types of diesel engine. __________________ 1a Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
Amendment 43 #
Proposal for a directive Recital 4 a (new) (4a) There is sufficient evidence of the carcinogenicity of diesel engine exhaust emissions. Diesel engine exhaust has been classified by the International Agency for Research on Cancer as carcinogenic (Group 1) to humans in 2012, based on sufficient evidence that exposure is associated with an increased risk for lung cancer. New diesel engine technology has changed the quality and quantity of diesel emissions and the associated cancer risks have been reduced but not eliminated. Due to the long transition time to switch from old to new diesel technology, a concomitant exposure to exhaust emissions from old and new diesel engines is expected to occur at work for the many years to come. Diesel engine exhaust emissions are process-generated and consequently they are not subject to classification in accordance with Regulation (EC) No 1272/2008. On the basis of available information, including scientific and technical data, a limit value for diesel engine exhaust emissions should be established. It is therefore appropriate to include work involving exposure to diesel engine exhaust emissions in Annex I and to establish a limit value for diesel engine exhaust emissions in Annex III to Directive 2004/37/EC. The entries in Annex I and Annex III to that Directive should cover fumes from all types of diesel engine and are thus irrespective of whether the exhaust emissions are from old or new diesel engines. Elemental carbon is known as the relevant marker of exposure to diesel engine exhaust emissions.
Amendment 44 #
Proposal for a directive Recital 4 b (new) (4b) There is sufficient evidence of the carcinogenicity of diesel engine exhaust emissions from old diesel engines. New diesel engine technology has changed the quality and quantity of diesel emissions and the associated cancer risks have been reduced but not eliminated. Due to the long transition time to switch from old to new diesel technology, a concomitant exposure to exhaust emissions from old and new diesel engines is expected to occur at work for the many years to come. Diesel engine exhaust emissions are process-generated and consequently they are not subject to classification in accordance with Regulation (EC) N° 1272/2008. On the basis of available information, including scientific and technical data, a limit value for diesel engine exhaust emissions should be established. It is therefore appropriate to include work involving exposure to diesel engine exhaust emissions in Annex I and to establish a limit value for diesel engine exhaust emissions in Annex III to Directive 2004/37/EC. The entries in Annex I and Annex III should cover fumes from all types of diesel engine and thus irrespective of whether the exhaust emissions are from old or new diesel engines.
Amendment 45 #
Proposal for a directive Recital 4 b (new) (4b) For new technology with significantly reduced diesel engine exhaust and elemental carbon mass concentrations, elemental carbon may not be an equally useful exposure indicator. Nitrogen dioxide is likely to be a more relevant exposure indicator for new technology diesel engine exhaust. Since the age and type of engines and exhaust after-treatment systems applied vary within and between workplaces, it may be appropriate to set an occupational exposure limit value for diesel exhaust both as respirable elemental carbon and as nitrogen dioxide. The Commission should review those limit values by using the most up-to-date scientific and socio- economic data. Both of those values should be fulfilled at workplaces where diesel engines are applied. Although data allowing a direct comparison of the carcinogenic potential of the diesel engine exhaust emitted by new technology and older technology diesel engines are not available, new diesel engine technology has changed the quality and quantity of diesel emissions and the associated carcinogenic risks have been reduced but not eliminated. The significant reduction of the diesel engine exhaust mass concentration in exhaust from new technology diesel engines is expected to reduce the risk of lung cancer (per kWh). This is supported by the findings from a single set of animal studies showing reduced or negligible in vivo lung genotoxicity and oxidative DNA damage after inhalation exposure to diesel exhaust from new technology diesel engines. Determination of relevant exposure indicators for new technology diesel engine exhaust, including consideration of the particle size distribution and different particle exposure metrics (e.g. number vs mass concentration) would be valuable. In addition, it is important to compare the hazard per mass unit of diesel engine exhaust from new and older technology diesel engines. Further information is also needed on exposure levels at workplaces where new diesel engines are in use.
Amendment 46 #
Proposal for a directive Recital 4 b (new) (4b) For new technology with significantly reduced diesel engine exhaust emissions and elemental carbon mass concentrations, elemental carbon may not be an equally useful exposure indicator. Nitrogen dioxide is likely to be a more relevant exposure indicator for new technology diesel engine exhaust. Since the age and type of engines and exhaust after-treatment systems applied vary within and between workplaces, it may be appropriate to set an occupational exposure limit value for diesel exhaust both as respirable elemental carbon and as nitrogen dioxide. The Commission should review those limit values by using the most up-to-date scientific and socio- economic data. Both of those values should be fulfilled at workplaces where diesel engines are applied. Although data allowing a direct comparison of the carcinogenic potential of the diesel engine exhaust emitted by new technology and older technology diesel engines are not available, new diesel engine technology has changed the quality and quantity of diesel emissions and the associated carcinogenic risks have been reduced but not eliminated. The significant reduction of the diesel engine exhaust mass concentration in exhaust from new technology diesel engines is expected to reduce the risk of lung cancer (per kWh). This is supported by the findings from a single set of animal studies showing reduced or negligible in vivo lung genotoxicity and oxidative DNA damage after inhalation exposure to diesel exhaust from new technology diesel engines. Determination of relevant exposure indicators for new technology diesel engine exhaust, including consideration of the particle size distribution and different particle exposure metrics (e.g. number vs mass concentration) would be valuable. In addition, it is important to compare the hazard per mass unit of diesel engine exhaust from new and older technology diesel engines. Further information is also needed on exposure levels at workplaces where new diesel engines are in use.
Amendment 47 #
Proposal for a directive Recital 5 (5) Maximum levels for the exposure of workers to some carcinogens or mutagens are established in Annex III by values which, pursuant to Directive 2004/37/EC, must
Amendment 48 #
Proposal for a directive Recital 6 (6) This Directive strengthens the protection of workers’ health and safety at their workplace. New limit values should be set out in Directive 2004/37/EC in the light of available information, including new scientific and technical data and evidence-based best practices, techniques and protocols for exposure level measurement at the workplace. That information should, if possible, include data on residual risks to the health of workers, recommendations of the Scientific Committee on Occupational Exposure Limits (SCOEL) and opinions of the Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA), as well as opinions of the Advisory Committee on Safety and Health at Work (ACSH). ). Information related to residual risk
Amendment 49 #
Proposal for a directive Recital 6 (6) This Directive strengthens the protection of workers’ health and safety at their workplace. The Commission should review it on a regular basis and make legislative proposals if appropriate. New limit values should be set out in Directive 2004/37/EC in the light of available information, including new scientific and technical data and evidence-based best practices, techniques and protocols for exposure level measurement at the workplace. That information should, if possible, include data on residual risks to the health of workers, recommendations of the Scientific Committee on Occupational Exposure Limits (SCOEL) and opinions of the Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA), as well as opinions of the Advisory Committee on Safety and Health at Work (ACSH). Information related to residual risk, made publicly available at Union level, is valuable for any future work to limit risks from occupational exposure to carcinogens and mutagens. Transparency of such information as well as its dissemination should be further encouraged.
Amendment 50 #
Proposal for a directive Recital 6 (6) This Directive strengthens the protection of workers’ health and safety at their workplace. New limit values should be set out in Directive 2004/37/EC in the light of available information, including new scientific and technical data and evidence-based best practices, techniques and protocols for exposure level measurement at the workplace. That information should, if possible, include data on residual risks to the health of workers, recommendations of the Scientific Committee on Occupational Exposure Limits (SCOEL)
Amendment 51 #
Proposal for a directive Recital 6 (6) This Directive strengthens the
Amendment 52 #
Proposal for a directive Recital 6 a (new) (6a) When setting a Binding Occupational Exposure Limits (BOELs), it should be based on robust assessment of the latest scientific information, as well as the availability of measurement techniques and economic feasibility after a rigorous process of consultation with the Advisory Committee on Safety and Health (ACSH). BOELs need to be evidence based, proportionate and measurable.
Amendment 53 #
Proposal for a directive Recital 7 (7) It is also necessary to consider other absorption pathways than inhalation of all carcinogens and mutagens, including the possibility of uptake through the skin, concretely through skin notation, in order to ensure the best possible level of protection. Amendments to Annex III to Directive 2004/37/EC provided for in this Directive constitute a further step in a longer term process initiated to update Directive 2004/37/EC.
Amendment 54 #
Proposal for a directive Recital 7 a (new) (7a) Many cytotoxic drugs are known to be genotoxic, carcinogenetic or mutagenic, however, it should be noted that the toxological and exposure data often do not discriminate between different cytotoxic.
Amendment 55 #
Proposal for a directive Recital 7 a (new) (7a) Work involving exposure to carcinogenic or mutagenic substances resulting from the preparation, administration or disposal of hazardous drugs (including cytotoxic drugs) which are carcinogenic and classified as IARC group 1, and in some cases substances that are classified as IARC group 2A and group 2B, or substances with a similar chemical structure or pharmacologic class as those described herein, should be considered for inclusion in the scope of directive 2004/34/EC 1a. Individual substances that should be evaluated for inclusion in the list of hazardous drugs (including cytotoxic drugs) in the directive include the alkylating agents Oxaliplatin, Carboplatin, Cyclophosphamide, Cisplatin, Bendamustine, Ifosfamide, Mechlorethamine, Melphalan, Busulfan, and Thiotepa. Alkylating agents are among the oldest and most prevalent drugs used to treat cancer but also widely regarded as the most hazardous class of carcinogenic drugs. Substances to be considered for inclusion should be able to comply with all provisions in the directive to ensure the occupational safety of workers handling those hazardous drugs and, in accordance with article 168(1) TFEU, access to the best available treatments for patients should not be questioned or jeopardised. __________________ 1a Relevant research, such as International Agency for Research on Cancer (IARC) Monographs Volume 100A “Pharmaceuticals” or Volume 26 “Some Antineoplastic and Immunosuppressive Agents” and published Supplements with an IARC group designation of 1, 2A, or 2B, or substances with a similar chemical structure or pharmacologic class as those described herein, shall be taken into account.
Amendment 56 #
Proposal for a directive Recital 7 a (new) (7a) Work involving exposure to carcinogenic or mutagenic substances resulting from the preparation, administration or disposal of hazardous drugs (including cytotoxic drugs) which are carcinogenic and classified as IARC group 1, and in some cases substances that are classified as IARC group 2A and group 2B, or substances with a similar chemical structure or pharmacologic class as those described herein, could be considered for inclusion in the directive. Individual substances that should be evaluated for inclusion in the list of hazardous drugs (including cytotoxic drugs) in the Directive including substances such as alkylating agents Oxaliplatin, Carboplatin, Cyclophosphamide, Cisplatin, Bendamustine, Ifosfamide, Mechlorethamine, Melphalan, Busulfan, and Thiotepa. Alkylating agents are among the oldest and most prevalent drugs used to treat cancer but also widely regarded as the most hazardous class of carcinogenic drugs. Substances to be considered for inclusion should be able to comply with all provisions in the directive to ensure the occupational safety of workers handling those hazardous drugs and, in accordance with article 168(1) TFEU, access to the best available treatments for patients should not be questioned or jeopardised.
Amendment 57 #
Proposal for a directive Recital 7 b (new) (7b) In order to protect the workers exposed to carcinogenic or mutagenic substances resulting from the preparation, administration or disposal of hazardous drugs (including cytotoxic drugs), the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending Annex I to Directive 2004/37/EC by inserting therein a list of hazardous drugs (including cytotoxic drugs),which are carcinogenic or mutagenic, on the basis of scientific data and consultation with the ACSH. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Amendment 58 #
Proposal for a directive Recital 7 b (new) (7b) The first obligation set out in Directive 2014/37/EC is the substitution requirement. This key provision is what sets that directive apart as the most stringent directive in the field of health and safety. The substances considered for that Directive should be appropriate for consideration with this obligation in mind. Simultaneously dangerous substances in the directive can have very important functions which oblige their use. This can relate to the role that for instance some cytotoxic substances play as part of life-saving drugs, (such as in the case of formalin and formaldehyde). The health and autonomy of patients and health care providers should be taken into account as part of the consideration when employers evaluate replacement of the substance "in so far as is technically possible", when it is necessary.
Amendment 59 #
Proposal for a directive Recital 7 b (new) (7b) Directive 2004/37/EC should be reviewed on an ongoing basis and revised when necessary in the light of scientific and technical data, including if possible data on residual risk, after consulting the Scientific Committee on Occupational Exposure Limits (SCOEL), the Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA) and the Advisory Committee on Safety and Health at Work (ACSH) for the purpose of keeping better protected workers. Limit values should be established for all carcinogens and mutagens for which the available information makes this possible, considering its technical and economic feasibility, and taking into account evidence based best practices, techniques and protocols for exposure level measurement in the workplace. The Commission should, taking into account latest developments in scientific knowledge, assess the option of amending the scope of that Directive to include cytotoxic drugs that are carcinogenic or mutagenic, or to conclude for other more appropriate legal instrument, in order to protect adequately the workers’ health. On that basis of this process, the Commission should present, if appropriate, and after consulting social partners, a legislative proposal.
Amendment 60 #
Proposal for a directive Recital 7 b (new) (7b) While recognising legitimate concerns regarding workers' exposure to cytotoxic drugs, extreme care needs to be taken when considering extending the scope of Directive 2004/73/EC.
Amendment 61 #
Proposal for a directive Recital 7 c (new) (7c) The Commission should continue to evaluate, using the most up to date scientific and socio-economic data, the need to extend the application of the measures for the protection of health and safety of workers contained in the Directive 2004/37/EC to other categories of carcinogens including cytotoxic drugs.
Amendment 62 #
Proposal for a directive Recital 8 a (new) (8a) The precautionary principle based on sound scientific assessment should be applied in the protection of workers' health and safety.
Amendment 63 #
Proposal for a directive Recital 10 a (new) (10a) The campaign launched by the European Agency for Safety and Health at Work (EU-OSHA) on 2018-2019 Healthy Workplaces Manage Dangerous Substances is a first step. EU-OSHA needs to work closely with Member States and reinforce the exchange of good practices, to provide tailored information and examples of good practices to workers in contact with certain substances, notably cytotoxic, highlighting policy developments and the legislative framework already in place.
Amendment 64 #
Proposal for a directive Recital 12 Amendment 65 #
Proposal for a directive Recital 12 (12) With regard to cadmium, a limit value of 0,001 mg/m3 may be difficult to be complied with in some sectors in the short term. A transitional period of
Amendment 66 #
Proposal for a directive Recital 14 (14) With regard to beryllium, a limit value of 0,0002 mg/m3 may be difficult to be complied with in some sectors in the short term. A transitional period of
Amendment 67 #
Proposal for a directive Recital 14 (14) With regard to beryllium, a limit value of 0,0002 mg/m3 may be difficult to be complied with in some sectors in the short term. A transitional period of
Amendment 68 #
Proposal for a directive Recital 17 (17) Formaldehyde meets the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and is therefore a carcinogen within the meaning of Directive 2004/37/EC. It is a local acting genotoxic carcinogen.
Amendment 69 #
Proposal for a directive Recital 17 a (new) (17a) As formalin (37% formaldehyde aqueous solution) is the agent universally used for the preservation of human tissue, a process which plays a role in the diagnosis of disease, it is important that the Commission puts in place safeguards for the continued use of formalin in order to secure Europe's public health.
Amendment 70 #
Proposal for a directive Recital 17 a (new) (17a) Formaldehyde is routinely used in European healthcare centres for the standardised fixation of tissue samples; a pathologist’s diagnosis of a variety of diseases, including cancer, is based on the recognition of microscopic traces in tissue fixed in formaldehyde.
Amendment 71 #
Proposal for a directive Recital 17 b (new) (17b) Until such time as other fixatives are available in the EU that are able to perform the crucial role that formaldehyde plays in patient care, the healthcare sector should be exempt from any restrictions on formaldehyde use that could give rise to multiple errors in diagnosis, putting countless European patients at risk.
Amendment 72 #
Proposal for a directive Recital 17 c (new) (17c) Healthcare centres in the EU should take all appropriate measures to keep formaldehyde exposure among their staff within safe limits.
Amendment 73 #
Proposal for a directive Recital 18 a (new) (18a) Certain polycyclic aromatic hydrocarbons (PAHs) mixtures meet the criteria for classification as carcinogenic in accordance with Regulation (EC) No 1272/2008 and therefore are carcinogens as defined in Directive 2004/37/EC. Exposure to such mixtures may occur during work involving burning processes, such as from combustion engine exhaust, and high temperature combustion processes, among others. The existing entry 2 in Annex I to that Directive should therefore be extended to also cover other occupational exposure situations during which workers are exposed to these substances and their mixtures. In addition, on the basis of available information, including scientific and technical data, it is appropriate to establish a limit value for PAHs mixtures with benzo[a]pyrene as indicator in part A.
Amendment 74 #
Proposal for a directive Recital 21 (21) The limit values
Amendment 75 #
Proposal for a directive Recital 21 (21) The limit values set out in this Directive are to be kept under permanent scrutiny and regular review to ensure consistency with Regulation (EC) No 1907/2006 of the European Parliament and of the Council50 , in particular to take account of the interaction between limit values set out under Directive 2004/37/EC and derived no effect levels for hazardous chemicals under that Regulation in order to protect workers effectively. __________________ 50 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council
Amendment 76 #
Proposal for a directive Recital 23 (23) In implementing this Directive Member States should
Amendment 77 #
Proposal for a directive Recital 23 (23) In implementing this Directive, Member States should avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings and healthcare facilities. Member
Amendment 78 #
Proposal for a directive Article 1 – paragraph -1 (new) Directive 2004/37/EC Recital 1 a (new) The following recital is inserted after recital 1: (1a) Articles 153, 154 and 155 TFEU establish the scope and authority of the social partners to negotiate and enforce agreements relating to occupational health and safety and the Charter of Fundamental Rights of the European Union guarantees, in particular, the fundamental right to life in Article 2, and the right to fair and just working conditions with respect to health, safety and dignity under Article 31(1), thereof.
Amendment 79 #
Proposal for a directive Article 1 – paragraph -1 a (new) Amendment 80 #
Proposal for a directive Article 1 – paragraph -1 (new) Directive 2004/37/EC Article 17 a (new) and Article 17 b (new) The following articles are inserted: "Article 17a Delegation of power By 30 September 2019, the Commission shall adopt a delegated act, in accordance with Article 17b, amending Annex I by inserting a list of hazardous drugs (including cytotoxic drugs), which are carcinogenic or mutagenic, on the basis of scientific data and consultation with the ACSH. Article 17b Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 17a shall be conferred on the Commission for an indeterminate period of time from [date of entry into force of this Directive. 3. The delegation of power referred to in Article 17a may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 17a shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council."
Amendment 81 #
Proposal for a directive Article 1 – paragraph -1 b (new) Directive 2004/37 Article 2 – paragraph 1 – point a – point i In Article 2, paragraph 1, point a, point i is replaced by the following: "(i) a substance or mixture which meets the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council and/or substances classified by the International Agency for Research on Cancer as carcinogens category group 1 or group 2A."
Amendment 82 #
Proposal for a directive Article 1 – paragraph -1 c (new) Directive 2004/37/EC Article 16 – paragraph 2 a (new) In Article 16 a new paragraph is inserted after paragraph 2: 2a. The limit values in Annex III shall ensure that the upper limit for the additional cancer risk as a result of working with substances listed in Annex III is below 1 in 2500 'over a 40-year working life of full time employment (40 hours/week)."
Amendment 83 #
Proposal for a directive Article 1 – paragraph -1 (new) Directive 2004/37 Article 18 a – paragraph 2 a (new) In Article 18a, the following paragraph is added: “By 30 June 2019, the Commission shall, after consulting the Member States and the social partners, assess the need to modify the limit values for diesel engine exhaust emissions. The Commission shall propose, where appropriate, necessary amendments related to that process.”
Amendment 84 #
Proposal for a directive Article 1 – paragraph -1 (new) Directive 2004/37/EC Article 18 b (new) The following article is inserted after Article 18a: “Article 18b By the fourth quarter of 2019 the European Commission shall present a legislative proposal aimed at insertion of a list of hazardous drugs (including cytotoxic drugs), which are carcinogenic or mutagenic, on the basis of scientific data and appropriate consultation, in Annex I.”
Amendment 85 #
Proposal for a directive Article 1 – paragraph -1 a (new) Directive 2004/37/EC Annex I – point 5 b (new) The following section is added to Annex I: «5b. Work involving exposure to diesel engine exhaust emissions.”
Amendment 86 #
Proposal for a directive Article 1 – paragraph -1 d (new) Directive 2004/37/EC Annex I – point 5 b (new) In Annex I of Directive 2004/37/EC the following point is added: “5b. Work involving exposure to diesel engine exhaust emissions”
Amendment 87 #
Proposal for a directive Article 1 – paragraph -1 e (new) Directive 2004/37/EC Annex I – point 5 d (new) In Annex I of Directive 2004/37/EC, the following point is added: “5d. Work involving exposure to polycyclic aromatic hydrocarbons present in coal soot, coal tar or coal pitch and work involving exposure to carcinogenic polycyclic aromatic hydrocarbons, in particular in any burning process, such as from combustion engine exhaust, and high temperature combustion processes, among others.”
Amendment 88 #
Proposal for a directive Article 1 – paragraph -1 f (new) Directive 2004/37/EC Annex II – point 2 a (new) Amendment 89 #
Proposal for a directive Article 2 – paragraph 1 a (new) 1a. Member States shall notify the Commission of the measures taken in accordance with national law and practices to ensure that their competent authorities have a sufficient number of trained staff and other resources necessary to carry out their tasks related to proper and effective implementation of this Directive. This information shall form part of the implementation reports submitted by Member States every five years pursuant to Article 17a of Council Directive 89/391/EEC.
Amendment 90 #
Proposal for a directive Annex Directive 2004/37/EC Annex III – Part A – table – row 1 Cadmium
Amendment 91 #
Proposal for a directive Annex Directive 2004/37/EC Annex III – Part A – table – row 1 Cadmium
Amendment 92 #
Proposal for a directive Annex I Directive 2004/37/EC Annex III – Part A – table – row 2 Beryllium
Amendment 93 #
Proposal for a directive Annex Directive 2004/37/EC Annex III – Part A – table – row 5 a (new) Diesel engine 0.051a exhaust emissions (irrespective of diesel engine types) ____________________ 1a mg/m3 measured as elemental carbone
Amendment 94 #
Proposal for a directive Annex Directive 2004/37/EC Annex III – Part A – table – row 5 a (new) Diesel - - 0,051a - - - - - - engine exhaust emissions ____________________ 1a Measured as elemental carbon.
Amendment 95 #
Proposal for a directive Annex Directive 2004/37/EC Annex III – Part A – table – row 5 a (new) Diesel engine - - 0,051a - - - - - - exhaust emissions ____________________ 1a Measured as elemental carbon
Amendment 96 #
Proposal for a directive Annex Directive 2004/37/EC Annex III – Part A – table – row 5 a (new) Diesel - - 0,0000111a - - - - - - engine exhaust emissions ____________________ 1a benzo[a]pyrene as a marker of total PAH concentration
Amendment 97 #
Proposal for a directive Annex Directive 2004/37/EC Annex III – Part A – table – row 5 b (new) Diesel - - - 0,51a - - - - - engine exhaust emissions ____________________ 1a Measured as nitrogen dioxide
Amendment 98 #
Proposal for a directive Annex Directive 2004/37/EC Annex III – Part A – table – row 5 b (new) Diesel engine - - 0,51a - - - - - - exhaust emissions ____________________ 1a Measured as nitrogen dioxide
Amendment 99 #
Proposal for a directive Annex Directive 2004/37/EC Annex III – Part A – table – row 5 b (new) Polycyclic aromatic - - 0,000071a - - - - - - hydrocarbons mixtures containing benzo[a]pyrene which are carcinogens within the meaning of the Directive ____________________ 1a benzo[a]pyrene as a marker of total PAH concentration
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