On the occasion of the recent publication in the Official Journal of the EU of the revised text of the Directive on Carcinogens, Mutagens and Reprotoxins at Work (Directive (EU) 2022/431), we interviewed Tony Musu, the senior researcher of the European Trade Union Institute (ETUI) who has been following this dossier for the European trade unions.

ETUI: The directive on carcinogens and mutagens has just been revised. What are the main changes?

TM: This is the fourth revision in less than five years. The first three introduced or revised mandatory occupational limit values (OELs) for 25 carcinogens. This fourth one targets three carcinogens: new OELs have been adopted for nickel compounds and acrylonitrile, while the existing OEL for benzene has been revised downwards. However, the main change concerns the Directive’s scope. Until now, the text only covered carcinogenic and mutagenic substances, while now it also covers reprotoxic substances. This constitutes a major step forward for the protection of the millions of workers in the EU exposed to these substances — causes of infertility, miscarriages and/or foetal malformations. Thanks to the amendments made by the European Parliament to the initial Commission text, this trade union demand, on the table for more than 20 years, has finally been taken up in the Directive. Legislation on protecting workers is now consistent with other EU legislation on chemicals (the REACH regulation, and regulations on pesticides, biocides, cosmetics, etc.), with identical rules for carcinogenic, mutagenic and reprotoxic substances (CMRs). Moreover, the 12 European OELs adopted for reprotoxic substances under the Chemical Agents Directive have been transferred to this new CMR Directive, Annex III of which now contains a total of 39 (groups of) substances with mandatory OELs (25 existing carcinogens + 2 new carcinogens + 12 reprotoxic substances).

ETUI: The text of the directive provides for a distinction to be made between reprotoxic substances with a threshold and those without one ("non-threshold" substances). What does this mean in concrete terms?

TM : It should be remembered that, for all substances within the scope of the Directive, employers are obliged to respect the hierarchy of prevention and protection measures defined in the text. The first measure is to eliminate a hazardous substance or to substitute it with a non- or less hazardous substance. Where this is not possible, the substance is to be used in a closed system. Where no closed system is possible, an employer must keep worker exposure as low as technically possible. This means that compliance with the binding OEL is not enough: exposure should be reduced below the OEL as much as possible, regardless of the cost. This is called the principle of exposure minimisation.

For reprotoxic substances, the new text introduces a distinction between those for which an exposure threshold can be defined, below which there are no harmful effects on workers’ health (reprotoxic substances with threshold) and those for which there may be harmful effects on their health regardless of the level of exposure (non-threshold reprotoxic substances). According to the text, in the first case (or if it is not known whether the reprotoxic substance is threshold or non-threshold), employers must ensure that the risk related to the exposure of workers is reduced to a minimum and in the second case they must ensure that the level of exposure of workers is reduced to as low a level as is technically possible. Risk is defined as a combination of a substance’s hazardous (i.e. its intrinsic properties) and the level of exposure to it. Since a substance’s intrinsic properties cannot be changed, the only thing that employers can do on is to reduce exposure. Finally, the principle of exposure minimisation applies to all reprotoxic substances, irrespective of whether they have a threshold or not.

ETUI: The inclusion of hazardous medicinal products in the scope of the directive was another major bone of contention during the negotiations between Parliament and Council. What happened here?

T.M.: Since some hazardous medicinal products are carcinogenic or reprotoxic for those handling them day in, day out, in the healthcare sector (e.g. cytostatic substances used to treat cancer patients), the European Parliament called for them to be covered by the directive’s provisions. The majority of Member States were opposed to this measure. At the end of the day, a compromise was reached to include these substances in the scope of the Directive but without mentioning them in Annex I (process-generated substances) or in Article 3 defining the Directive’s scope. A new recital has been introduced to indicate that hazardous medicinal products which are CMRs within the meaning of the legislation are indeed covered by the Directive, while Article 11 explicitly mentions them by providing that specific training must be given to those handling them. Moreover, the Commission is under obligation to update European guidelines on the preparation, administration and disposal of hazardous medicinal products in the workplace by the end of 2022 and to draw up a definition and establish an indicative list of hazardous medicinal products that are CMRs no later than one year after the Directive’s transposition.

ETUI: Are there any other new provisions set to improve the level of protection for workers exposed to CMR substances?

T.M.: Yes, other improvements to the Directive include various obligations imposed on the European Commission. First of all, it must present an action plan before the end of 2022 for the adoption of binding OELs for 25 additional CMR substances; second, it is under obligation to review the existing limit value for crystalline silica, a carcinogen affecting more than five million workers in the EU, and to propose a new limit value for cobalt and its inorganic compounds by the end of 2024. Finally, we should mention the obligation for the European Commission and the European Advisory Committee on Health and Safety at Work (ACSH) to develop a new method — the "Risk-Based Approach" — for defining OELs for carcinogens at European level. This method should enable more protective OELs to be developed for workers exposed to carcinogens.

ETUI: Is this Directive set to change again in the short or medium term?

T.M.: In its new European strategy for occupational health and safety for the period 2021-2027, the European Commission has announced the revision of the existing OELs for lead and its compounds in 2022. Following the extension of the Directive’s scope to reprotoxic substances, the OELs for lead compounds are included in the recently adopted CMR directive. The Directive is thus set to return to the co-legislators’ table very soon for a fifth revision. In the medium term, it is also expected that binding OELs for new CMR substances will be adopted under this legislation in line with the action plan to be defined by the Commission before the end of 2022.