Directive (EU) 2022/431 of the European Parliament and of the Council of 9 March 2022 amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work

‘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.’;

‘1 This Directive shall apply to activities in which workers are or are likely to be exposed to carcinogens, mutagens or reprotoxic substances as a result of their work.’;

‘2 In the case of any activity likely to involve a risk of exposure to carcinogens, 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. The assessment shall be renewed regularly and in any event when any change occurs in the conditions which may affect workers’ exposure to carcinogens, mutagens or reprotoxic substances.’;

‘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, mutagens or reprotoxic substances.’;

‘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.’;

‘2 Where it is not technically possible to replace the carcinogen, 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, mutagen or reprotoxic substance is, in so far as is technically possible, manufactured and used in a closed system.

3 Where a closed system is not technically possible, the employer shall ensure that the level of exposure of workers to the carcinogen, mutagen or non-threshold reprotoxic substance is reduced to as low a level as is technically possible.

3a Where it is not technically possible to use or manufacture a threshold reprotoxic substance in a closed system, the employer shall ensure that the risk related to the exposure of workers to that threshold reprotoxic substance is reduced to a minimum.

3b The employer shall, with regard to reprotoxic substances other than non-threshold reprotoxic substances and threshold reprotoxic substances, apply paragraph 3a of this Article. In such a case, when carrying out the risk assessment referred to in Article 3, the employer shall duly take into account the possibility that a safe level of exposure for workers’ health for such a reprotoxic substance might not exist and shall lay down appropriate measures in that regard.

4 Exposure shall not exceed the limit value of a carcinogen, mutagen or a reprotoxic substance as set out in Annex III.’;

‘5 Wherever a carcinogen, mutagen or reprotoxic substance is used, the employer shall apply all the following measures:’;

‘1 Employers shall be obliged, in the case of all activities for which there is a risk of contamination by carcinogens, mutagens or reprotoxic substances, to take appropriate measures to ensure that:’;

‘2 Employers shall inform workers of installations and related containers containing carcinogens, mutagens or reprotoxic substances, ensure that all containers, packages and installations containing carcinogens, mutagens or reprotoxic substances are labelled clearly and legibly, and display clearly visible warning and hazard signs. Where a biological limit value has been set in Annex IIIa, health surveillance shall be mandatory for working with the carcinogen, mutagen or reprotoxic substance in question, in accordance with the procedures laid down in that Annex. Workers shall be informed of that requirement before being assigned to the task involving the risk of exposure to the carcinogen, mutagen or reprotoxic substance indicated.’;

‘3 If a worker is found to be suffering from an abnormality which is suspected to be the result of exposure to carcinogens, mutagens or reprotoxic substances, or if a biological limit value is found to have been exceeded, the doctor or authority responsible for the health surveillance of workers may require other workers who have been similarly exposed to undergo health surveillance.’;

‘4 In cases where health surveillance is carried out, an individual medical record shall be kept and the doctor or authority responsible for health surveillance shall propose any protective or preventive measures to be taken in respect of any individual workers. Biological monitoring and related requirements may form part of health surveillance.’;

‘8 All cases of cancer, adverse effects on sexual function and fertility in adult male and female workers or developmental toxicity in their offspring identified in accordance with national law or practice as resulting from occupational exposure to a carcinogen, mutagen or reprotoxic substance shall be notified to the competent authority.’;

‘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.’;

‘1 The European Parliament and the Council shall, in accordance with the procedure laid down in Article 153(2), point (b), of the Treaty on the Functioning of the European Union (TFEU), set out limit values in Directives on the basis of the available information, including scientific and technical data, in respect of all those carcinogens, mutagens or reprotoxic substances for which this is possible, and, where necessary, other directly related provisions.’;

‘3 The European Parliament and the Council shall, in accordance with the procedure laid down in Article 153(2), point (b), TFEU, set out biological limit values in Directives on the basis of the available information, including scientific and technical data, together with other relevant health surveillance information.

4 Biological limit values and other health surveillance information are set out in Annex IIIa.’;

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.’;

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.’;

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.

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Directive is addressed to the Member States.