(1)

Directive 2004/37/EC of the European Parliament and the Council (3) aims to protect workers against risks to their health and safety from exposure to carcinogens or mutagens at the place of work. A consistent level of protection from the risks related to the occupational exposure to carcinogens and mutagens is provided for in that Directive by a framework of general principles to enable Member States to ensure the consistent application of minimum requirements. The aim of these minimum requirements is to protect workers at Union level. More stringent provisions can be set by Member States.

(2)

By setting minimum requirements for workers’ protection across the Union, Directive 2004/37/EC improves clarity and contributes to a more level playing field for the economic actors in the sectors that use the substances falling within the scope of that Directive, thereby demonstrating the importance of Union action in this field.

(3)

According to the latest scientific evidence, reprotoxic substances can cause adverse effects on sexual function and fertility in adult males and females, as well as on the development of their offspring. Similarly to carcinogens or mutagens, reprotoxic substances are substances of very high concern which may have serious and irreversible effects on workers’ health. Therefore, reprotoxic substances should also be regulated under Directive 2004/37/EC in order to improve consistency with, inter alia, Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4) and to ensure a similar level of minimum protection at Union level.

(4)

For most reprotoxic substances, it is scientifically possible to identify levels below which exposure would not lead to adverse health effects. The exposure minimisation requirements laid down in Directive 2004/37/EC should apply only to reprotoxic substances for which it is not possible to identify a safe level of exposure and which are identified as ‘non-threshold’ in the notation column of the Annex III to Directive 2004/37/EC. With regard to all other reprotoxic substances, employers should ensure that the risk related to the exposure of workers is reduced to a minimum.

(5)

According to the latest scientific data, biological limit values may be necessary in specific cases to protect workers from exposure to some carcinogens, mutagens or reprotoxic substances. Biological limit values and relevant related provisions should therefore be included in Directive 2004/37/EC.

(6)

Principle 10 of the European Pillar of Social Rights (5), 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 for the right of workers to a high level of protection of their health and safety at work, which includes protection from the exposure to carcinogens, mutagens and reprotoxic substances at the place of work.

(7)

Binding occupational exposure limit values are an 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 carcinogens, mutagens and reprotoxic substances for which the available information, including up-to-date scientific and technical data, make it possible to do so.

(8)

For mutagens and most carcinogens, it is not scientifically possible to identify levels below which exposure would not lead to adverse health effects. Although setting limit values for exposure at the place of work in relation to carcinogens and mutagens in 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 by means of the stepwise and goal-setting approach that was adopted in that Directive.

(9)

Binding occupational exposure limit values are without prejudice to other employers’ obligations pursuant to Directive 2004/37/EC, such as the reduction of the use of carcinogens, mutagens and reprotoxic substances at the place of work, the prevention or reduction of workers’ exposure to carcinogens, mutagens and reprotoxic substances, or to 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, mutagen and reprotoxic substance by a substance, mixture or process which is not dangerous or which is less dangerous to workers’ health, the use of a closed system, or other measures aiming to reduce the level of workers’ exposure.

(10)

There is a need for workers to receive sufficient and appropriate training when they are exposed or are likely to be exposed to carcinogens, mutagens or reprotoxic substances, including those contained in certain hazardous medicinal products. The training that the employer is required to provide pursuant to Article 11 of Directive 2004/37/EC should be adapted to take account of a new or changed risk, in particular when workers are exposed to new carcinogens, mutagens or reprotoxic substances or to a number of different carcinogens, mutagens or reprotoxic substances, including in hazardous medicinal products, or in the case of changing circumstances related to work.

(11)

Certain hazardous medicinal products contain one or more substances which meet the criteria for classification as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B) or toxic for reproduction (category 1A or 1B) in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (6) and therefore fall within the scope of Directive 2004/37/EC. However, clear and updated information concerning whether a medicinal product meets those criteria is not easily accessible to workers, employers or enforcement authorities. In order to ensure the proper implementation of Directive 2004/37/EC and to provide clarity with regard to the use of and risks relating to the handling of those hazardous medicinal products, it is necessary to take steps to help employers to identify them. The Commission, in line with the Commission communication of 28 June 2021 on an EU strategic framework on health and safety at work 2021-2027, is to provide guidelines, including on training, protocols, surveillance and monitoring, for protecting workers against exposure to hazardous medicinal products.

(12)

With regard to the risk assessment provided in Article 3 of Directive 2004/37/EC, when assessing exposure to hazardous medicinal products falling within the scope of that Directive, employers should pay specific attention to ensure that the requirement to replace such products would not be to the detriment of patients’ health.

(13)

This Directive strengthens the protection of workers’ health and safety at the place of work. New limit values should be set out in Directive 2004/37/EC in light of available information, including up-to-date 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 place of work. 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 established by Regulation (EC) No 1907/2006 (ECHA) and opinions of the Advisory Committee on Safety and Health at Work established by a Council Decision of 22 July 2003 (7) (ACSH). Information related to residual risk that has been made publicly available at Union level is valuable for any future work to limit risks from occupational exposure to carcinogens, mutagens and reprotoxic substances.

(14)

The Commission should task the ACSH with further exploring the possibility to adopt a risk-based methodology on the basis of available information, including scientific and technical data, with the aim of setting limit values at an exposure level corresponding to a risk of developing an adverse health effect, such as cancer, including the option of establishing them in the range between an upper and a lower risk level.

(15)

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, 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.

(16)

It is also necessary to consider absorption pathways other than inhalation for all carcinogens, mutagens and reprotoxic substances, including the possibility of uptake through the skin, in order to ensure the best possible level of protection. Further notations for hazardous substances and mixtures are laid down in Regulation (EC) No 1272/2008.

(17)

The assessment of health effects of the carcinogens subject to this Directive is based on the relevant scientific expertise provided by the RAC. Pursuant to a Service Level Agreement signed by the Commission’s Directorate-General for Employment, Social Affairs and Inclusion and ECHA, RAC provides scientific evaluations on the toxicological profile of each of the selected priority chemical substances in relation to their adverse effects on workers’ health.

(18)

Acrylonitrile 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 possible, on the basis of the available information, including scientific and technical data, to set a long- and short-term limit value for that carcinogen. Acrylonitrile can also be absorbed through the skin. It is therefore appropriate to establish a limit value for acrylonitrile within the scope of Directive 2004/37/EC and to assign a skin notation to it. The ACSH, based on the RAC opinion, agreed that biological monitoring for acrylonitrile would be useful. This should be considered when developing guidance on the practical use of biological monitoring.

(19)

With regard to acrylonitrile, a limit value of 1 mg/m3 (0,45 ppm) and a short-term limit value of 4 mg/m3 (1,8 ppm) may be difficult to comply with in the short term. A transitional period of four years after entry into force of this Directive from which those Occupational Exposure Limit (OEL) values apply should be introduced.

(20)

Nickel compounds meet the criteria for classification as carcinogenic (category 1A) 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 nickel compounds at the place of work may also result in dermal sensitisation and sensitisation of the respiratory tract. It is therefore appropriate to establish limit values for both the inhalable and respirable fractions of the nickel compounds within the scope of Directive 2004/37/EC and to assign a notation for dermal and respiratory sensitisation.

(21)

With regard to nickel compounds, limit values of 0,01 mg/m3 for the respirable fraction and 0,05 mg/m3 for the inhalable fraction may be difficult to comply with in a number of sectors or processes, in particular smelting, refineries and welding. Furthermore, since identical risk management measures can be used both for chromium (VI) and nickel compounds, the transitional measures aiming to reduce the exposure to these two groups of carcinogens should be aligned. Therefore, a transitional period until 17 January 2025 inclusive should be introduced during which a limit value of 0,1 mg/m3 for the inhalable fraction of the nickel compounds should apply. The transitional period would ensure alignment with the date of application of the OEL for Chromium (VI) compounds adopted in Directive (EU) 2017/2398 of the European Parliament and of the Council (8).

(22)

Benzene meets the criteria for classification as carcinogenic (category 1A) in accordance with Regulation (EC) No 1272/2008 and is therefore a 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 light of more recent scientific data and it is appropriate to keep the skin notation. The ACSH, based on the RAC opinion, agreed that the biological monitoring for benzene would be useful. This should be considered when developing guidance on the practical use of biological monitoring.

(23)

With regard to benzene, a revised limit value of 0,2 ppm (0,66 mg/m3) may be difficult to comply with in some sectors in the short term. A transitional period of four years after entry into force of this Directive should therefore be introduced. As a transitional measure, the limit value of 1 ppm (3,25 mg/m3) provided for in Directive (EU) 2019/130 of the European Parliament and the Council (9) should continue to apply until 5 April 2024 and a transitional limit value of 0,5 ppm (1,65 mg/m3) should apply from 5 April 2024 until 5 April 2026.

(24)

The limit value for respirable crystalline silica dust set out in Annex III to Directive (EU) 2017/2398 should be revised in light of the Commission’s evaluations pursuant to Directive 2004/37/EC and recent scientific and technical data.

(25)

The Commission has carried out a two-stage consultation of management and labour at Union level in accordance with Article 154 of the Treaty on the Functioning of the European Union. It has also consulted the ACSH, which has adopted opinions for all priority substances concerned by this Directive, recommended one or several binding occupational exposure limit values for each of them, as well as notations, where appropriate.

(26)

The limit values established in this Directive are to be kept under regular scrutiny and review to ensure consistency with Regulation (EC) No 1907/2006. In particular, with regard to benzene, the Commission, in close cooperation with the ACSH, will assess the feasibility of a further reduction of the OEL, taking into account the RAC opinion of 2018 and any new relevant information.

(27)

Since the objective of this Directive, namely to protect 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, 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.

(28)

Since this Directive concerns the protection of the health and safety of workers at the place of work, it should be transposed within two years of the date of its entry into force.

(29)

Directive 2004/37/EC should therefore be amended accordingly,