Legal provisions of COM(2020)571 - Amendment of Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
dossier | COM(2020)571 - Amendment of Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens ... |
---|---|
document | COM(2020)571 ![]() |
date | March 9, 2022 |
Article 1
Amendments to Directive 2004/37/EC
Directive 2004/37/EC is amended as follows:
(1) | the title 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, mutagens or reprotoxic substances at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC)’; |
(2) | in Article 1(1), the first subparagraph is replaced by the following: ‘1. This Directive has as its aim the protection of workers against risks to their health and safety arising from or likely to arise from exposure to carcinogens, mutagens or reprotoxic substances at work, including the prevention of such risks.’; |
(3) | Article 2 is amended as follows:
|
(4) | Article 3 is amended as follows:
|
(5) | in Article 4, paragraph 1 is replaced by the following: ‘1. The employer shall reduce the use of a carcinogen, mutagen or reprotoxic substance at the place of work, in particular by replacing it, in so far as is technically possible, by a substance, mixture or process which, under its conditions of use, is not dangerous or is less dangerous to workers’ health or safety, as the case may be.’; |
(6) | Article 5 is amended as follows:
|
(7) | in Article 6, first paragraph, points (a) and (b) are replaced by the following:
|
(8) | Article 10(1) is amended as follows:
|
(9) | Article 11 is amended as follows:
|
(10) | Article 14 is amended as follows:
|
(11) | in Article 15, paragraph 1 is replaced by the following: ‘1. With regard to carcinogens and mutagens, the list referred to in Article 12, point (c), and the medical record referred to in Article 14(4) shall be kept for at least 40 years following the end of exposure, in accordance with national law or practice. 1a. With regard to reprotoxic substances, the list referred to in Article 12, point (c), and the medical record referred to in Article 14(4) shall be kept for at least five years following the end of exposure, in accordance with national law or practice.’; |
(12) | Article 16 is amended as follows:
|
(13) | the following Article is inserted: ‘Article 16a Identification of non-threshold and threshold reprotoxic substances The European Parliament and the Council shall, in accordance with the procedure laid down in Article 153(2), point (b), TFEU, identify, on the basis of the available scientific and technical data, in the notations column of Annex III to this Directive whether a reprotoxic substance is a non-threshold reprotoxic substance or a threshold reprotoxic substance.’; |
(14) | in Article 17, the first paragraph 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, mutagens or reprotoxic substances.’; |
(15) | Article 18a is replaced by the following: ‘Article 18a Evaluation The Commission shall, as part of the next evaluation of the implementation of this Directive in the context of the evaluation referred to in Article 17a of Directive 89/391/EEC, also evaluate the need to modify the limit value for respirable crystalline silica dust. The Commission shall launch this process in 2022 and, where appropriate, shall subsequently propose necessary amendments and modifications related to that substance in a subsequent revision of this Directive. No later than 11 July 2022, the Commission shall assess the option of amending this Directive to add provisions on a combination of an airborne occupational exposure limit and a biological limit value for cadmium and its inorganic compounds. No later than 31 December 2022, where appropriate, after consulting the Advisory Committee for Safety and Health at Work (ACSH) and taking into account the existing recommendations of different agencies, stakeholders and the World Health Organization, on priority carcinogens, mutagens and reprotoxic substances for which limit values are needed, the Commission shall present an action plan to achieve new or revised occupational exposure limits values for at least 25 substances, groups of substances or process-generated substances. Where appropriate, taking into account that action plan, the latest developments in scientific knowledge, and after consulting the ACSH, the Commission shall present legislative proposals pursuant to Article 16 without delay. Where appropriate and no later than 5 April 2025, taking into account the latest developments in scientific knowledge and after appropriate consultation of relevant stakeholders, the Commission shall develop a definition and establish an indicative list of hazardous medicinal products or the substances contained therein, which meet the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008, a mutagen or a reprotoxic substance. No later than 31 December 2022, the Commission shall, after appropriate consultation of relevant stakeholders, prepare Union guidelines for the preparation, administration, and disposal of hazardous medicinal products at the place of work. Those guidelines shall be published on the website of EU-OSHA and shall be disseminated in all Member States by the relevant competent authorities. Where appropriate, after receipt of an opinion from the ACSH, the Commission shall, taking into account the existing methodology for setting limit values for carcinogens in some Member States and the opinion of the ACSH, establish upper and lower risk levels. No later than 12 months after receipt of the ACSH opinion, the Commission shall, after appropriate consultation of relevant stakeholders, prepare Union guidelines on the methodology establishing risk-based limit values. Those guidelines shall be published on the EU-OSHA website and disseminated in all Member States by the relevant competent authorities. No later than 31 December 2024, the Commission shall, taking into account the latest developments in scientific knowledge, and after appropriate consultation of relevant stakeholders, propose, where appropriate, a limit value for cobalt and inorganic cobalt compounds.’; |
(16) | in Annex II, point 1 is replaced by the following:
|
(17) | Annex III is amended in accordance with the Annex to this Directive. |
Article 2
Transposition
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 5 April 2024. They shall immediately communicate the text of those measures to the Commission.
When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
2. Member States shall communicate to the Commission the text of the main measures of national law which they adopt in the field covered by this Directive.
Article 3
Entry into force
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 4
Addressees
This Directive is addressed to the Member States.