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
Date: 2022-03-09

num: Article 1
title: Amendments to Directive 2004/37/EC
paragraphs: 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:
(a)
the following points are inserted:
‘(ba)
“reprotoxic substance” means a substance or mixture, which meets the criteria for classification as a category 1A or 1B reproductive toxicant set out in Annex I to Regulation (EC) No 1272/2008;
(bb)
“non-threshold reprotoxic substance” means a reprotoxic substance to which there is no safe level of exposure for workers’ health and which is identified as such in the notation column of Annex III;
(bc)
“threshold reprotoxic substance” means a reprotoxic substance for which a safe level of exposure exists below which there is no risk to workers’ health and which is identified as such in the notation column of Annex III;’;
(b)
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, 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;’;
(c)
the following points are added:
‘(d)
“biological limit value” means the limit of the concentration in the appropriate biological medium of the relevant agent, its metabolite, or an indicator of effect;
(e)
“health surveillance” means the assessment of an individual worker to determine the state of health of that individual, as related to exposure to specific carcinogens, mutagens or reprotoxic substances at work.’;
(4)
Article 3 is amended as follows:
(a)
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, mutagens or reprotoxic substances as a result of their work.’;
(b)
in paragraph 2, the first and second subparagraphs are replaced by the following:
‘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.’;
(c)
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, mutagens or reprotoxic substances.’;
(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:
(a)
paragraphs 2, 3 and 4 are replaced by the following:
‘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.’;
(b)
paragraph 5 is amended as follows:
(i)
the introductory wording is replaced by the following:
‘5. Wherever a carcinogen, mutagen or reprotoxic substance is used, the employer shall apply all the following measures:’;
(ii)
point (a) is replaced by the following:
‘(a)
limitation of the quantities of a carcinogen, mutagen or reprotoxic substance at the place of work;’;
(iii)
points (c), (d) and (e) are replaced by the following:
‘(c)
design of work processes and engineering control measures so as to avoid or minimise the release of carcinogens, mutagens or reprotoxic substances into the place of work;
(d)
evacuation of carcinogens, 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;
(e)
use of existing appropriate procedures for the measurement of carcinogens, mutagens or reprotoxic substances, in particular for the early detection of abnormal exposures resulting from an unforeseeable event or an accident;’;
(iv)
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, mutagens or reprotoxic substances;’;
(7)
in Article 6, first paragraph, points (a) and (b) are replaced by the following:
‘(a)
the activities and/or industrial processes carried out, including the reasons for which carcinogens, mutagens or reprotoxic substances are used;
(b)
the quantities of substances or mixtures manufactured or used which contain carcinogens, mutagens or reprotoxic substances;’;
(8)
Article 10(1) is amended as follows:
(a)
the introductory wording 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, mutagens or reprotoxic substances, to take appropriate measures to ensure that:’;
(b)
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, mutagens or reprotoxic substances;’;
(9)
Article 11 is amended as follows:
(a)
in paragraph 1, the second subparagraph is replaced by the following:
‘The training shall be:
—
adapted to take account of new or changed risk, in particular when workers are or are likely to be exposed to new carcinogens, mutagens or reprotoxic substances or to a number of different carcinogens, mutagens or reprotoxic substances, including those contained in hazardous medicinal products, or in case of changing circumstances related to work,
—
provided periodically in healthcare settings to all workers who are exposed to carcinogens, mutagens or reprotoxic substances, in particular where new hazardous medicinal products containing those substances are used, and
—
repeated periodically in other settings if necessary.’;
(b)
paragraph 2 is replaced by the following:
‘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.’;
(10)
Article 14 is amended as follows:
(a)
in paragraph 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, 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.’;
(b)
paragraph 4 is replaced by the following:
‘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.’;
(c)
in paragraph 8, the first subparagraph is replaced by the following:
‘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.’;
(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:
(a)
paragraph 1 is replaced by the following:
‘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.’;
(b)
the following paragraphs are added:
‘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.’;
(13)
the following Article is inserted:
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:
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:
‘1.
The doctor and/or authority responsible for the health surveillance of workers exposed to carcinogens, mutagens or reprotoxic substances must be familiar with the exposure conditions or circumstances of each worker.’;
(17)
Annex III is amended in accordance with the Annex to this Directive.
num: Article 2
title: Transposition
paragraphs: 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.
num: Article 3
title: Entry into force
paragraphs: This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
num: Article 4
title: Addressees
paragraphs: This Directive is addressed to the Member States.