Considerations on COM(2023)738 - 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) (codification)

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dossier COM(2023)738 - Protection of workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work (Sixth ...
document COM(2023)738 EN
date November 27, 2023
 
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(1)Directive 2004/37/EC of the European Parliament and of the Council 7 has been substantially amended several times 8 . In the interests of clarity and rationality, that Directive should be codified.


ê 2022/431 recital 1 (adapted)

(2)Ö This Õ Directive aims to protect workers against risks to their health and safety from exposure to carcinogens, mutagens Ö or reprotoxic substances Õ at the place of work. A consistent level of protection from the risks related to the occupational exposure to carcinogens, mutagens Ö or reprotoxic substances Õ is provided for in Ö this Õ 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.


ê 2022/431 recital 2 (adapted)

(3)By setting minimum requirements for workers’ protection across the Union, Ö this Õ Directive Ö provides Õ clarity and contributes to a more level playing field for the economic actors in the sectors that use the substances falling within Ö its Õ scope, thereby demonstrating the importance of Union action in this field.


ê 2004/37/EC recital 3 (adapted)

(4)This Directive is an individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC 9 . Therefore the provisions of that Directive are fully applicable to the exposure of workers to carcinogens, mutagens Ö or reprotoxic substances Õ, without prejudice to more stringent and/or specific provisions contained in this Directive.


ê 2004/37/EC recital 5

(5)Germ cell mutagens are substances that can cause a permanent change in the amount or structure of the genetic material of a cell resulting in a change in the phenotypic characteristics of that cell, which may be transferred to descendent daughter cells.


ê 2004/37/EC recital 6

(6)Because of their mechanism of action, germ cell mutagens are likely to have carcinogenic effects.


ê 2022/431 recital 3 (adapted)

(7)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.


ê 2022/431 recital 4 (adapted)

(8)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 Ö this Õ Directive 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 Annex III. With regard to all other reprotoxic substances, employers should ensure that the risk related to the exposure of workers is reduced to a minimum.


ê 2022/431 recital 5 (adapted)

(9)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.


ê 2022/431 recital 6

(10)Principle 10 of the European Pillar of Social Rights 10 , 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.


ê 2022/431 recital 7 (adapted)

(11)Binding occupational exposure limit values are an important component of the general arrangements for the protection of workers established by Ö this Õ 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.


ê 2022/431 recital 8 (adapted)

(12)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 Ö this Õ 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 adopted in Ö this Õ Directive.


ê 2022/431 recital 9 (adapted)

(13)Binding occupational exposure limit values are without prejudice to other employers’ obligations pursuant to Ö this Õ, 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.


ê 2022/431 recital 10 (adapted)

(14)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 Ö this Õ Directive 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.


ê 2022/431 recital 11 (adapted)

(15)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 11 and therefore fall within the scope of Ö this Õ Directive. 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 Ö this Õ Directive 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.


ê 2022/431 recital 12 (adapted)

(16)With regard to the risk assessment provided in Ö this Õ Directive, when assessing exposure to hazardous medicinal products falling within the scope of Ö this Õ Directive, employers should pay specific attention to ensure that the requirement to replace such products would not be to the detriment of patients’ health.


ê 2022/431 recital 13 (adapted)

(17)This Directive strengthens the protection of workers’ health and safety at the place of work. Limit values should be set out in Ö this Õ Directive 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 (ECHA) established by Regulation (EC) No 1907/2006 of the European Parliament and of the Council 12 and opinions of the Advisory Committee on Safety and Health at Work established by a Council Decision of 22 July 2003 13 (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.


ê 2022/431 recital 15

(18)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.


ê 2022/431 recital 16

(19)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.


ê 2004/37/EC recital 14

(20)The precautionary principle should be applied in the protection of workers' health.


ê 2004/37/EC recital 15 (adapted)

(21)Preventive measures must be taken for the protection of the health and safety of workers exposed to carcinogens, mutagens Ö or reprotoxic substances Õ.


ê 2022/431 recital 26

(22)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.


ê 2022/431 recital 18 (adapted)

(23)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.


ê 2022/431 recital 22 (adapted)

(24)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.


ê 2019/983 recital 18

(25)Setting a biological limit value for cadmium and its inorganic compounds would protect workers against their systemic toxicity, which mainly affects the kidneys and bones. Biological monitoring can thus contribute to the protection of workers at the workplace, but only as a means of complementing the monitoring of the concentration of cadmium and its inorganic compounds in the air and therefore within the breathing zone of workers. The Commission should issue practical guidelines for biological monitoring.


ê 2019/130 recital 9 (adapted)

(26)The ACSH is a tripartite body that assists the Commission in the preparation, implementation and evaluation of activities in the field of occupational health and safety. In particular, the ACSH adopts tripartite opinions on initiatives to set occupational exposure limit values at Union level on the basis of the available information, including scientific and technical data as well as data on social aspects and on the economic feasibility of those initiatives.


ê 2019/130 recital 19 (adapted)

(27)In light of evolving scientific evidence and technical progress, the limit values for Ö trichloroethylene Õ should be kept under particularly close review.


ê 2019/130 recital 24 (adapted)

(28)The ‘Agreement on Workers' Health Protection Through the Good Handling and Use of Crystalline Silica and Products Containing it’, signed by the associations that form the European Network for Silica (NEPSI), and other social partners' agreements, which provide, in addition to regulatory measures, guidance and tools in order to support the effective implementation of the employers' obligations laid down in Ö this Õ Directive, are valuable instruments to complement regulatory measures. While respecting their autonomy, the Commission should encourage the social partners to conclude such agreements. However, compliance with such agreements should not give rise to a presumption of conformity with the employers' obligations laid down in Ö this Õ Directive. A regularly updated list of such agreements should be published on the European Agency for Safety and Health at Work (EU-OSHA) website.


ê 2017/2398 recital 13 (adapted)

(29)The limit values for vinyl chloride monomer and hardwood dusts set out in Annex III to Ö this Õ Directive should be revised in the light of more recent scientific and technical data. The distinction between hardwood and softwood dust should be further assessed as regards the limit value set out in that Annex, as recommended by the Ö Scientific Committee on Occupational Exposure Limits Õ and the International Agency for Research on Cancer.


ê 2017/2398 recital 30

(30)In its opinions, the ACSH has referred to a review period for binding occupational exposure limit values for several substances, such as respirable crystalline silica dust, acrylamide and 1,3-butadiene. The Commission is to take into account those opinions when prioritising substances for scientific evaluation.


ê 2017/2398 recital 31

(31)In its opinion on refractory ceramic fibres, the ACSH agreed that a binding occupational exposure limit value is necessary but failed to reach a common position on a threshold. The Commission should therefore encourage the ACSH to submit an up-to-date opinion on refractory ceramic fibres with a view to reaching a common position on the limit value for that substance, without prejudice to the working methods of the ACSH and the autonomy of the social partners.


ê 2004/37/EC recital 18 (adapted)

(32)This Directive Ö should be Õ without prejudice to the obligations of the Member States Ö relating to Õ the time-limits for Ö the Õ transposition Ö into national law and the dates of application of the Directives Õ set out in Part B of Annex V.