Diario Oficial de la Unión Europea del 16/3/2022 - Sección Legislación
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Source: Diario Oficial de la Unión Europea - Sección Legislación
L 88/2
EN
Official Journal of the European Union
16.3.2022
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.
4 Regulation EC No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals REACH, establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation EEC No 793/93 and Commission Regulation EC No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC OJ L 396, 30.12.2006, p. 1.
5 OJ C 428, 13.12.2017, p. 10.
