57 Amendments of Sara MATTHIEU related to 2020/0262(COD)
Amendment 16 #
Proposal for a directive
Recital 1 a (new)
Recital 1 a (new)
(1a) In the workplace, workers and other persons are often exposed to a cocktail of substances, which can increase health risks, cause adverse effects on their reproductive systems and cause impaired fertility or infertility, and have a negative impact on foetal development and lactation. Substances which are toxic to reproduction are of very high concern and the organisation of workplace prevention should apply the same approach as for carcinogens and mutagens. As not all reprotoxic substances are threshold substances, it is of utmost importance to enlarge the scope of Directive 2004/37/EC to reprotoxic substances in order to bring it in line with Regulation (EC) No 1907/2006 of the European Parliament and of the Council1a. This is necessary to better protect workers and their children and to ensure the safe participation of all workers in the workplace, in particular female workers who are pregnant or breastfeeding. In Regulation (EC) No 1907/2006, half of the 211 substances identified as substances of very high concern are reprotoxic substances. As is the case in some Member States, the organisation of workplace prevention should therefore apply the same approach to carcinogens, mutagens and reprotoxic substances, thus ensuring legal coherence and a level playing field across Member States.. ____________________ 1aRegulation (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 19 #
Proposal for a directive
Recital 2
Recital 2
(2) Principle 10 of the European Pillar of Social Rights46 , jointly proclaimed by the European Parliament, the Council and the Commission at the Social Summit for Fair Jobs and Growth on 17 November 2017, provides workers’ right to a high level of protection of their health and safety at work, which includes the protection from the exposure to carcinogens and mutagen, mutagens and reprotoxic substances at the workplace. __________________ 46European Pillar of Social Rights, November 2017, available at : https://ec.europa.eu/commission/sites/beta- political/files/social-summit-european- pillar-social-rights-booklet_en.pdf
Amendment 21 #
Proposal for a directive
Recital 2 a (new)
Recital 2 a (new)
(2a) 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 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 2021, put forward an action plan to achieve occupational exposure limits for at least 25 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 welding fumes, asphalt fumes, leather dust, Poly Aromatic Hydrocarbons (PAHs), 1-4dioxane, isoprene. Reprotoxic substances should include lead and lead compounds, Bisphenol-A, Carbon Monoxide, Mercury and divalent inorganic mercury compounds, N-methyl- 2-pyrrolidone, N,N-Dimethylacetamide, Nitrobenzene, N,N Dimethylformamide, 2-Methoxy ethanol, 2-Methoxyethyl acetate, 2-Ethoxyethanol, 2-Ethoxyethyl acetate, di(2-ethylhexyl)phthalate, benzyl butyl phthalate and dibutyl phthalate.
Amendment 25 #
Proposal for a directive
Recital 3
Recital 3
(3) Binding occupational exposure limit values are important component of the general arrangements for the protection of workers established by Directive 2004/37/EC and must not be exceeded. Limit values and other directly related provisions should be established for all those carcinogens or, mutagens and reprotoxic substances for which the available information, including scientific and technical data, make this possible.
Amendment 27 #
Proposal for a directive
Recital 4
Recital 4
(4) Compliance with binding occupational exposure limit values is without prejudice to other employers’ obligations pursuant to Directive 2004/37/EC, such as the reduction of the use of carcinogens and mutagen, mutagens and reprotoxic substances at the workplace, the prevention or reduction of workers’ exposure to carcinogens or mutagen, mutagens or reprotoxic substances 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 and reprotoxic substance 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.
Amendment 38 #
Proposal for a directive
Recital 5
Recital 5
(5) 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 ofusing a risk-based methodology. All available information should be considered, including new scientific and technical data and should also be based on, a thorough assessment of the socioeconomic impact and the availability of exposure measurement protocols and techniques at the workplace. That information should, if possible, include data on residual risks to the health of workers, 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.
Amendment 39 #
Proposal for a directive
Recital 5
Recital 5
(5) 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 should also be based on a thorough assessment of the socioeconomic impact and availability of exposure measurement protocols and techniques at the workplace. That information should, if possible, include data on residual risks to the health of workers, 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 mutagen, mutagens and reprotoxic substances.
Amendment 40 #
Proposal for a directive
Recital 6
Recital 6
(6) In accordance with the recommendations of the RAC and the ACSH, where possible, limit values for the inhalation route of exposure are established in relation to a reference period of eight hours time-weighted average (long-term exposure limit values) and, for certain carcinogens or, mutagens and reprotoxic substances to a shorter reference period, in general fifteen minutes time-weighted average (short-term exposure limit values), in order to limit, to the extent possible, the effects arising from short-term exposure.
Amendment 41 #
Proposal for a directive
Recital 7
Recital 7
(7) It is also necessary to consider other absorption pathways other than inhalation of all carcinogens and mutagen, mutagens and reprotoxic substances, including the possibility of uptake through the skin, in order to ensure the best possible level of protection.
Amendment 42 #
Proposal for a directive
Recital 7 a (new)
Recital 7 a (new)
(7a) 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 52 #
Proposal for a directive
Recital 13
Recital 13
(13) 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 55 #
Proposal for a directive
Recital 14 a (new)
Recital 14 a (new)
(14a) Cobalt and cobalt compounds meet the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and are therefore carcinogens within the meaning of Directive 2004/37/EC. It is possible, on the basis of the available information, including scientific and technical data, to set limit values for that group of carcinogens. Exposure to cobalt and cobalt compounds at workplaces may also result in dermal sensitisation and sensitisation of the respiratory tract. It is therefore appropriate to establish two limit values for both the inhalable and respirable fractions of cobalt and its compounds under the scope of Directive 2004/37/EC and to assign a notation for dermal and respiratory sensitisation.
Amendment 57 #
Proposal for a directive
Recital 14 b (new)
Recital 14 b (new)
(14b) Hazardous Medicinal Products can cause adverse health effects, such as certain types of cancer and reproductive disorders, in workers who are exposed to them in the course of work involving their preparation, administration, or disposal. Hazardous Medicinal Products affect workers who handle them directly or indirectly. Such workers include healthcare workers using cytostatic or cytotoxic drugs to treat cancer patients in hospitals or at home and workers who carry out activities relating to the cleaning, transport, laundry, or the waste disposal of hazardous drugs or of material contaminated by such drugs. It is therefore important to protect all workers by including relevant pharmacotherapeutic groups of Hazardous Medicinal Products in Annex I to Directive 2004/37/EC. The reduction and replacement requirements laid down in Article 4 of that Directive do not apply to Hazardous Medicinal Products because they are essential to treat patients. The other provisions of that Directive, in particular Articles 5 to 18a thereof, as amended by this Regulation, apply to workers who are exposed to Hazardous Medicinal Products.
Amendment 61 #
Proposal for a directive
Recital 17
Recital 17
(17) Since the objective of this Directive, namely to protect workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to carcinogens or mutagen, mutagens or reprotoxic substances at work, cannot be sufficiently achieved by the Member States, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.
Amendment 64 #
Proposal for a directive
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2004/37/EC
Title
Title
(-1) The title of Directive 2004/37/EC is replaced by the following: "DIRECTIVE 2004/37/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagen, mutagens or reprotoxic substances at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC)"
Amendment 65 #
Proposal for a directive
Article 1 – point -1 a (new)
Article 1 – point -1 a (new)
Directive 2004/37/EC
Article 1 – paragraph 1 – subparagraph 1
Article 1 – paragraph 1 – subparagraph 1
(-1a) In Article 1(1), the first paragraph is replaced by the following: “1. This Directive has as its aim the protection of workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to carcinogens or, mutagens or reprotoxic substances at work.”
Amendment 66 #
Proposal for a directive
Article 1 – point -1 b (new)
Article 1 – point -1 b (new)
Directive 2004/37/EC
Article 2 – point b a (new)
Article 2 – point b a (new)
(-1b) In Article 2, the following point is inserted: "(ba) 'reprotoxic substance' means: a substance or mixture which meets the criteria for being classified as toxic to reproduction category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008;"
Amendment 67 #
Proposal for a directive
Article 1 – point -1 c (new)
Article 1 – point -1 c (new)
Directive 2004/37/EC
Article 2 – point c (new)
Article 2 – point c (new)
(-1c) ‘In Article 2, point (c) is replaced by the following: “(c) 'limit value’' means, unless otherwise specified, the limit of the time- weighted average of the concentration for a ‘'carcinogen or mutagen’, mutagen or reprotoxic substance' in the air within the breathing zone of a worker in relation to a specified reference period as set out in Annex III to this Directive.”
Amendment 68 #
Proposal for a directive
Article 1 – point -1 d (new)
Article 1 – point -1 d (new)
Directive 2004/37/EC
Article 2 – point c a (new)
Article 2 – point c a (new)
(-1d) In Article 2, the following point is added: "(ca) 'risk-based limit value' means: a limit value set at an exposure level corresponding to a risk of developing an adverse health effect (e.g. cancer) in the range between an upper and a lower risk level, which is to be set in accordance with the procedure laid down in Article 153(2) of the Treaty on the Functioning of the European Union (TFEU)."
Amendment 69 #
Proposal for a directive
Article 1 – point -1 e (new)
Article 1 – point -1 e (new)
Directive 2004/37/EC
Article 3 – paragraph 1
Article 3 – paragraph 1
(-1e) In Article 3, paragraph 1 is replaced by the following: "1. This Directive shall apply to activities in which workers are or are likely to be exposed to carcinogens or, mutagens or reprotoxic substances as a result of their work.”
Amendment 70 #
Proposal for a directive
Article 1 – point -1 f (new)
Article 1 – point -1 f (new)
Directive 2004/37/EC
Article 3 – paragraph 2 – subparagraph 1
Article 3 – paragraph 2 – subparagraph 1
(-1f) In Article 3(2), the first subparagraph is replaced by the following: "In the case of any activity likely to involve a risk of exposure to carcinogens or mutagens, or reprotoxic substances; the nature, degree and duration of workers' exposure shall be determined by way of a systematic risk assessment, in order to make it possible to assess any risk to the workers' health or safety and to lay down the measures to be taken. The assessment shall be renewed regularly and in any event when any change occurs in the conditions which may affect workers' exposure to carcinogens or mutagen, mutagens or reprotoxic substances. The employer shall supply the authorities responsible at their request with the information used for making the assessment. " Or. en (02004L0037)
Amendment 71 #
Proposal for a directive
Article 1 – point -1 g (new)
Article 1 – point -1 g (new)
Directive 2004/37/EC
Article 3 – paragraph 2 – subparagraph 1
Article 3 – paragraph 2 – subparagraph 1
(-1g) In Article 3(2), the first subparagraph is replaced by the following: "In the case of any activity likely to involve a risk of exposure to carcinogens or mutagen, mutagens or reprotoxic substances, the nature, degree and duration of workers' exposure shall be determined in order to make it possible to assess any risk to the workers' health or safety and to lay down the measures to be taken.”
Amendment 72 #
Proposal for a directive
Article 1 – point -1 h (new)
Article 1 – point -1 h (new)
Directive 2004/37/EC
Article 3 – paragraph 2 – subparagraph 2
Article 3 – paragraph 2 – subparagraph 2
(-1h) In Article 3(2), the second subparagraph is replaced by the following: “The assessment shall be renewed regularly and in any event when any change occurs in the conditions which may affect workers' exposure to carcinogens or, mutagens. or reprotoxic substances.”
Amendment 73 #
Proposal for a directive
Article 1 – point -1 i (new)
Article 1 – point -1 i (new)
Directive 2004/37/EC
Article 3 – paragraph 4
Article 3 – paragraph 4
(-1i) In Article 3, paragraph 4 is replaced by the following: "4. When the risk assessment is carried out, employers shall give particular attention to any effects concerning the health or safety of workers at particular risk and shall, inter alia, take account of the desirability of not employing such workers in areas where they may come into contact with carcinogens or, mutagens. or reprotoxic substances.”
Amendment 74 #
Proposal for a directive
Article 1 – point -1 j (new)
Article 1 – point -1 j (new)
Directive 2004/37/EC
Article 4 – paragraph 1
Article 4 – paragraph 1
Amendment 75 #
Proposal for a directive
Article 1 – point -1 k (new)
Article 1 – point -1 k (new)
Directive 2004/37/EC
Article 5 – paragraph 2
Article 5 – paragraph 2
(-1k) In Article 5, paragraph 2 is replaced by the following: “2. Where it is not technically possible to replace the carcinogen or, mutagen or reprotoxic substance by a substance, mixture or process which, under its conditions of use, is not dangerous or is less dangerous to health or safety, the employer shall ensure that the carcinogen or, mutagen or reprotoxic substance is, in so far as is technically possible, manufactured and used in a closed system.”
Amendment 76 #
Proposal for a directive
Article 1 – point -1 l (new)
Article 1 – point -1 l (new)
Directive 2004/37/EC
Article 5 – paragraph 4
Article 5 – paragraph 4
(-1l) In Article 5, paragraph 4 is replaced by the following: “4. Exposure shall not exceed the limit value of a carcinogen, mutagen or reprotoxic substance as set out in Annex III.”
Amendment 77 #
Proposal for a directive
Article 1 – point -1 m (new)
Article 1 – point -1 m (new)
Directive 2004/37/EC
Article 5 – paragraph 4
Article 5 – paragraph 4
Amendment 78 #
Proposal for a directive
Article 2 – point -1 n (new)
Article 2 – point -1 n (new)
Directive 2004/37/EC
Article 5 – paragraph 5 – introductory part
Article 5 – paragraph 5 – introductory part
-1n. In Article 5(5), the introductory part is replaced by the following: “5. Wherever a carcinogen or, mutagen or reprotoxic substance is used, the employer shall apply all the following measures:”
Amendment 79 #
Proposal for a directive
Article 1 – point -1 o (new)
Article 1 – point -1 o (new)
Directive 2004/37/EC
Article 5 – paragraph 5 – point a
Article 5 – paragraph 5 – point a
(-1o) In Article 5(5), point (a) is replaced by the following: “(a) limitation of the quantities of a carcinogen or, mutagen or reprotoxic substance at the place of work;”
Amendment 80 #
Proposal for a directive
Article 1 – point -1 p (new)
Article 1 – point -1 p (new)
Directive 2004/37/EC
Article 5 – paragraph 5 – point c
Article 5 – paragraph 5 – point c
(-1p) In Article 5(5), point (c) is replaced by the following: "(c) design of work processes and engineering control measures so as to avoid or minimise the release of carcinogens or, mutagens or reprotoxic substances into the place of work;”
Amendment 81 #
Proposal for a directive
Article 1 – point -1 q (new)
Article 1 – point -1 q (new)
Directive 2004/37/EC
Article 5 – paragraph 5 – point d
Article 5 – paragraph 5 – point d
(-1q) In Article 5(5), point (d) is replaced by the following: “(d) evacuation of carcinogens or, mutagens or reprotoxic substances at source, local extraction system or general ventilation, all such methods to be appropriate and compatible with the need to protect public health and the environment;”
Amendment 82 #
Proposal for a directive
Article 1 – point -1 r (new)
Article 1 – point -1 r (new)
Directive 2004/37/EC
Article 5 – paragraph 5 – point e
Article 5 – paragraph 5 – point e
(-1r) In Article 5(5), point (e) is replaced by the following: “(e) use of existing appropriate procedures for the measurement of carcinogens or mutagen, mutagens or reprotoxic substances, in particular for the early detection of abnormal exposures resulting from an unforeseeable event or an accident;”
Amendment 83 #
Proposal for a directive
Article 1 – point -1 s (new)
Article 1 – point -1 s (new)
Directive 2004/37/EC
Article 5 – paragraph 5 – point i a (new)
Article 5 – paragraph 5 – point i a (new)
(-1s) In Article 5(5), the following point is inserted: "(ia) ensure that personal protective equipment is provided;"
Amendment 84 #
Proposal for a directive
Article 1 – point -1 t (new)
Article 1 – point -1 t (new)
Directive 2004/37/EC
Article 5 – paragraph 5 – point j
Article 5 – paragraph 5 – point j
(-1t) In Article 5(5), point (j) is replaced by the following: “(j) demarcation of risk areas and use of adequate warning and safety signs including ‘'no smoking’' signs in areas where workers are exposed or likely to be exposed to carcinogens or mutagen, mutagens or reprotoxic substances;”
Amendment 85 #
Proposal for a directive
Article 1 – point -1 u (new)
Article 1 – point -1 u (new)
Directive 2004/37/EC
Article 5 – paragraph 5 – point m a (new)
Article 5 – paragraph 5 – point m a (new)
(-1u) In Article 5(5), the following point is added: "(ma) in accordance with Directive 92/85/EC, take the necessary measures to ensure that pregnant workers, workers who have recently given birth and workers who are breastfeeding are duly protected and are in no circumstances required to carry out activities which could jeopardise their safety or health."
Amendment 86 #
Proposal for a directive
Article 1 – point -1 v (new)
Article 1 – point -1 v (new)
Directive 2004/37/EC
Article 6 – paragraph 1– point a
Article 6 – paragraph 1– point a
(-1v) In the first paragraph of Article 6, point (a) is replaced by the following: "(a) the activities and/or industrial processes carried out, including the reasons for which carcinogens or, mutagens or reprotoxic substances are used;”
Amendment 87 #
Proposal for a directive
Article 1 – point -1 w (new)
Article 1 – point -1 w (new)
Directive 2004/37/EC
Article 6 – paragraph 1 – point b
Article 6 – paragraph 1 – point b
(-1w) In the first paragraph of Article 6, point (b) is replaced by the following: “(b) the quantities of substances or mixtures manufactured or used which contain carcinogens or mutagen, mutagens or reprotoxic substances; "
Amendment 88 #
Proposal for a directive
Article 1 – point -1 x (new)
Article 1 – point -1 x (new)
Directive 2004/37/EC
Article 10 – paragraph 1 – introductory part
Article 10 – paragraph 1 – introductory part
(-1x) In Article 10 (1), the introductory part is replaced by the following: “1. Employers shall be obliged, in the case of all activities for which there is a risk of contamination by carcinogens or mutagen, mutagens or reprotoxic substances, to take appropriate measures to ensure that:”
Amendment 89 #
Proposal for a directive
Article 1 – point -1 y (new)
Article 1 – point -1 y (new)
Directive 2004/37/EC
Article 10 – paragraph 1 – point a
Article 10 – paragraph 1 – point a
(-1y) In Article 10(1), point (a) is replaced by the following: “(a) workers do not eat, drink or smoke in working areas where there is a risk of contamination by carcinogens or, mutagens; or reprotoxic substances;”
Amendment 91 #
Proposal for a directive
Article 1 – point -1 aa (new)
Article 1 – point -1 aa (new)
Directive 2004/37/EC
Article 11 – paragraph 1 – subparagraph 2 – indents 1 and 2
Article 11 – paragraph 1 – subparagraph 2 – indents 1 and 2
Amendment 92 #
Proposal for a directive
Article 1 – point -1 ab (new)
Article 1 – point -1 ab (new)
Directive 2004/37/EC
Article 11 – paragraph 2
Article 11 – paragraph 2
(-1ab) In Article 11, paragraph 2 is replaced by the following: “2. Employers shall inform workers of installations and related containers containing carcinogens or, mutagens or reprotoxic substances, ensure that all containers, packages and installations containing carcinogens or mutagen, mutagens or reprotoxic substances are labelled clearly and legibly, and display clearly visible warning and hazard signs.”
Amendment 93 #
Proposal for a directive
Article 1 – point -1 ac (new)
Article 1 – point -1 ac (new)
Directive 2004/37/EC
Article 14 – paragraph 3 – subparagraph 1
Article 14 – paragraph 3 – subparagraph 1
(-1ac) In Article 14(3), the first subparagraph is replaced by the following: “3. If a worker is found to be suffering from an abnormality which is suspected to be the result of exposure to carcinogens or mutagen, mutagens or reprotoxic substances, the doctor or authority responsible for the health surveillance of workers may require other workers who have been similarly exposed to undergo health surveillance. ”
Amendment 94 #
Proposal for a directive
Article 1 – point -1 ad (new)
Article 1 – point -1 ad (new)
Directive 2004/37/EC
Article 14 – paragraph 8 – subparagraph 1
Article 14 – paragraph 8 – subparagraph 1
Amendment 95 #
Proposal for a directive
Article 1 – point -1 ae (new)
Article 1 – point -1 ae (new)
Directive 2004/37/EC
Article 14 – paragraph 8 – subparagraph 1
Article 14 – paragraph 8 – subparagraph 1
Amendment 96 #
Proposal for a directive
Article 1 – point -1 af (new)
Article 1 – point -1 af (new)
Directive 2004/37/EC
Article 15 – paragraph 2 a (new)
Article 15 – paragraph 2 a (new)
(-1af) In Article 15, the following paragraph is added: “2a. The Member States shall provide the Commission with the information referred to in Article 14(8) as part of the implementation reports submitted to the Commission pursuant to Article 17a of Directive 89/391/EEC.”
Amendment 97 #
Proposal for a directive
Article 1 – point -1 ag (new)
Article 1 – point -1 ag (new)
Directive 2004/37/EC
Article 16 – paragraph 1
Article 16 – paragraph 1
Amendment 98 #
Proposal for a directive
Article 1 – point -1 ah (new)
Article 1 – point -1 ah (new)
Directive 2004/37/EC
Article 16 – paragraph 1
Article 16 – paragraph 1
Amendment 99 #
Proposal for a directive
Article 1 – point -1 ai (new)
Article 1 – point -1 ai (new)
Directive 2004/37/EC
Article 17 – paragraph 1
Article 17 – paragraph 1
(-1 ai) In Article 17, paragraph 1 is replaced by the following: "The Commission is empowered to adopt delegated acts in accordance with Article 17a to make strictly technical amendments to Annex II, in order to take account of technical progress, changes in international regulations or specifications and new findings with regard to carcinogens or, mutagens. or reprotoxic substances.”
Amendment 100 #
Proposal for a directive
Article 1 – point -1 aj (new)
Article 1 – point -1 aj (new)
Directive 2004/37/EC
Article 18a – paragraph 4 a (new)
Article 18a – paragraph 4 a (new)
(-1 aj) In Article 18a, the following paragraph is added: “No later than 1 December 2022, the Commission shall, taking into account the latest developments in scientific knowledge, 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) should be adapted in the case of exposure to a combination of substances. Those guidelines shall be published on the website of the EU-OSHA and be disseminated in all Member States.”
Amendment 102 #
Proposal for a directive
Article 1 – point -1 al (new)
Article 1 – point -1 al (new)
Directive 2004/37/EC
Article 18a – paragraph 4 a (new)
Article 18a – paragraph 4 a (new)
(-1al) 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 103 #
Proposal for a directive
Article 1 – point -1 am (new)
Article 1 – point -1 am (new)
Directive 2004/37/EC
Article 18a – paragraph 4 a (new)
Article 18a – paragraph 4 a (new)
(-1 am) In Article 18a, the following paragraph is added: “No later than 31 December 2021, the Commission shall, 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, and after consulting the ACSH, present an action plan to achieve occupational exposure limits values for at least 25 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 at least 25 additional substances or group of substances and/or process generated substances, the latest developments in scientific knowledge, and after consulting of the ACSH, present a legislative proposal.”
Amendment 104 #
Proposal for a directive
Article 1 – point -1an (new)
Article 1 – point -1an (new)
Directive 2004/37/EC
Article 18a – paragraph 4 a (new)
Article 18a – paragraph 4 a (new)
(-1an) In Article 18a, the following paragraph is added: “No later than 1 March 2022, the Commission shall, taking into account the latest developments in scientific knowledge, and after appropriate consultation of relevant stakeholders, in particular health practitioners and health professionals, develop a definition of Hazardous Medicinal Products and establish the list of substances covered by the related entry in Annex I. The Commission shall review that list every two years. No later than 1 December 2022, the Commission shall, after the appropriate consultation of relevant stakeholders, prepare Union guidelines and standards of practice for the preparation, administration, and disposal of Hazardous Medicinal Products. Those guidelines and standards shall be published on the website of the European Agency for Safety and Health at Work (EU-OSHA) and shall be disseminated in all Member States. The consultations undertaken to develop the definition, list, guidelines and standards shall be transparent. The declarations of interests of stakeholders and experts shall be made public in a timely manner.”
Amendment 105 #
Proposal for a directive
Article 1 – point -1ao (new)
Article 1 – point -1ao (new)
Directive 2004/37/EC
Article 18a – paragraph 4 a (new)
Article 18a – paragraph 4 a (new)
(-1ao) In Article 18 a, the following paragraph is inserted after the second paragraph: “No later than 1 June 2022, the Commission shall, taking into account the existing methodology to set limit values for carcinogens in some Member States and the opinion of the ACSH, define the upper and lower risk levels referred to in Article 2. No later than 1 December 2022, the Commission shall, after appropriate consultation of relevant stakeholders, prepare Union guidelines on the methodology establishing risk-based limit values under this Directive. Those guidelines shall be published on the website of the (EU-OSHA) and be disseminated in all Member States.”
Amendment 106 #
Proposal for a directive
Article 1 – point -1 ap (new)
Article 1 – point -1 ap (new)
Directive 2004/37/EC
Annex I – point 8 a (new)
Annex I – point 8 a (new)
(-1 ap) In Annex I the following point is added: “8a. Work involving exposure to Hazardous Medicinal Products as defined by the process outlined in article 18a and, meeting the criteria for classification as carcinogenic, mutagenic and/or toxic for reproduction category 1A or 1B set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council.”
Amendment 107 #
Proposal for a directive
Article 1 – point -1 aq (new)
Article 1 – point -1 aq (new)
Directive 2004/37/EC
Annex II – point 1
Annex II – point 1
(-1aq) In Annex II, point 1 is replaced by the following: “1. The doctor and/or authority responsible for the health surveillance of workers exposed to carcinogens or, mutagens or reprotoxic substances must be familiar with the exposure conditions or circumstances of each worker.”
Amendment 112 #
Proposal for a directive
Annex I – point 2
Annex I – point 2
Directive 2004/37/EC
Annex III – point A – Row 2 a (new)
Annex III – point A – Row 2 a (new)
Cobalt and - - 0.0005(11a) - - - - - Dermal and - cobalt 0.001(11b) respiratory compounds sensitisation (11) (11a) Respirable fraction, measured as cobalt (11b) Inhalable fraction, measured as cobalt