Occupational Health and Safety

New update of the directive on carcinogens and mutagens

In-depth study of the changes made by Dir (EU) 2022/431 on the management of reprotoxic substances

Directive (EU) 2022/431 amending Directive 2004/37/EC on the protection of workers from the risks arising from exposure to carcinogens or mutagens at work was published on 9 March.

A new update of the directive that confirms what has already been announced in the previous Dir. (EU) 2017/2398 on the extension of the scope to reprotoxic substances of category 1A and 1B.

The changes will not be implemented soon, but it is essential to use the time allowed to get ready for the deadline. With this in-depth analysis, we will examinate the main changes made by the new directive, in particular on the operational aspects which will have to be planned in the next period.

Directive 2004/37/EC, as amended by Directive (EU) 2022/431, will later be referred to as the "CMR Directive".

1.    Amendments to the CRM directive


Before analysing the amendments to the CMR Directive, it is necessary to dwell on the new concept introduced: reprotoxicants must be managed in the same way as carcinogens and mutagens.

For reprotoxic substances it will no longer be possible to manage the risk through a "normal" chemical risk assessment, but it will be necessary to prepare an assessment of exposure to reprotoxic agents equivalent to that currently required when working with carcinogens or mutagens. The assessment of exposure to carcinogens and mutagens (and reprotoxic) differs from the chemical risk assessment in that it is based exclusively on exposure data (e.g., sampling of airborne substances or biological monitoring) and provides that the first assessment concerns the possibility of replacing the substance with less dangerous substances.  Where it is not possible to replace the substance, the CMR Directive requires the substance to be used in a closed system and therefore completely contained. But some processes cannot be confined completely, in this case, the company must introduce plant and procedural interventions to reduce exposure to the lowest possible level, and at least below the limit value (if any).

About exposure’s reduction, the CMR Directive specifies some relevant information. We know that for mutagens and various carcinogens it is not possible to identify a "threshold" of exposure safe enough to eliminate the risk of pathology, while for several reprotoxic it is possible.  This means that for all non-threshold substances the minimisation of exposure to the lowest possible values, so lower than the limit of quantification of the measuring instrument, must be sought in the working environment, while for threshold substances the presence of the substance in air is acceptable but at low levels and certainly lower than the respective exposure limit (compliance with the limit assessed with the criteria of the technical standard UNI EN 689:2019). The CMR Directive announces that "non-threshold" substances will also be listed in Annex III where the limit values are set out, so it will be applied the principle of minimising exposure.

Further special obligations which will also apply to substances toxic to reproduction are, for example, the compilation and dispatch of the register of exposed employees or specific training for exposed workers.

Finally, the assessment of exposure to carcinogens and mutagens does not only refer to the substances used and manufactured, but also to other chemical agents developed by the processes, such as fumes or waste.

Considering that the substitution of a substance or the modification of plants/procedures takes time, it is essential that companies start to evaluate the available options from now on. At the end of this study, we propose a work plan to be ready for the definitive entry into force of the new requirements.


Amendment to annex III (Exposure limit values)

Annex III of CMR Directive, which lists the exposure limit values, has been amended and supplemented.

The limit value of Benzene has been modified, lowered to 0.66 mg/m3 (previously it was 3.25 mg/m3) which is still reached in intermediate steps:

New limit values for nickel compounds and acrylonitrile have been introduced :

As can be seen, these new limit values also have a transitional period of application.

Furthermore, the OEL values already present in the Chemical Agents Directive (CAD) relating to reprotoxic substances have also been transposed into the CMR Directive. Values were introduced for the following 12 substances:

  • inorganic lead and its compounds;
  • N, N-dimethylacetamide
  • Nitrobenzene
  • N, N Dimethylformamide
  • 2-methoxyethanol
  • 2-Methyloxyethyl acetate
  • 2-Ethoxy ethanol,
  • 2-Ethoxyethyl acetate
  • 1-Methyl-2-pyrrolidone,
  • mercury e inorganic composti divalenti del mercurio compresi ossido mercurico e chloruro di mercurio (misurati come mercury), Mercury and divalent inorganic mercury compounds including mercuric oxide and mercuric chloride (measured as mercury)
  • Bisfenol A; 4,4′-isopropylidedifenolo
  • Carbon monoxide

It has been also moved in the CMR directive the biological limit value reported to the Lead, already transposed in the D. Lgs. 81/08 and subsequent amendments and additions. In this regard, Annex IIIA has been specially introduced, which shall contain other biological limit values for CMRs.

Future amendments to the limit values

Directive (EU) 2022/431 announces some news for the future on new limit values, or rather, the Directive wants the European Commission to evaluate aspects related to the issue of limit values, in particular:

  • consider changing the limit value for respirable crystalline silica powder ;
  • consider including provisions for the combination of an occupational exposure limit in air and a biological limit value for cadmium and its inorganic compounds;
  • submit by 31 December 2022 an action plan to define or revise the limit values for at least 25 substances;
  • propose a limit value for cobalt and its inorganic compounds .

The directive gives a mandate to the European Commission, considering the existing methodology for setting limit values for carcinogens, to establish minimum and maximum risk levels to develop guidance on the methodology for setting risk-based limit values.  In other words, the Commission should instruct the CCSS to further examine the possibility of adopting a risk-based methodology, based on available information, including scientific and technical data, to set limit values at an exposure level corresponding to the risk of developing a harmful effect on health, such as a tumour, including establish them in the range between an upper and a lower level of risk. This would be quite a novelty and could lead to new reference values for carcinogens.


Attention to medicines

Directive (EU) 2022/431 focuses on drug management. We know that some medicines may contain CMR substances, but at the same time medicines are excluded from the labelling requirements of Reg. CLP or from the provision of safety data sheets under Reg. REACH when they are finished. This means that workers' exposure to CMR drugs may not be known, and the risk may not be properly assessed. The directive requires the European Commission to draw up a definition and styles an indicative list of dangerous drugs or substances that contain them in accordance with the criteria for classification as CMR category 1 A or 1B. In addition, by 31 December 2022, the European Commission will draw up guidelines for the preparation, administration and disposal of dangerous drugs in the workplace.

The text of the directive also clarifies how the training of workers exposed to CMR drugs must be guaranteed and repeated periodically, in the same way as any CMR user.

Entry into force

Directive (EU) 2022/431 will enter into force on Tuesday 5 April 2022 and must be transposed by Member States by 5 April 2024. In Italy we will then have to adopt a special measure to amend the D. Lgs. 81/08 and subsequent amendments; in particular Chapter II of Title IX and Annexes XXXIX and XLIII.


2.    Conclusions and operative advice

The impacts on companies are important, especially for those who are not used to working with carcinogens and mutagens today. Changes will become operational in a couple of years, however, because of their potentially important impact, it is essential to get ready for the final transposition into Italian law. For this purpose, we present below a list of activities that we believe should be performed by the final entry into force:

  1. Define an overview about reprotoxic agents present in the company:
    1. substances and mixtures classified Repr.1A and Repr.1B in the list of products (both used and manufactured)
    2. Overview of the substances developed by the processes and identification of those having hazard characteristics specific to the classification as reprotoxic
    3. Overview of waste classified HP10 (reprotoxic)
  2. Evaluation of possible substitution/elimination of reprotoxic agents
  3. If they are not replaceable/disposable, consider using them in a closed system. The plant and equipment used should be modified to ensure the containment of these substances.
  4. Where closed-system use is not technically possible, the company shall provide for plant and procedural measures to reduce workers' exposure
  5. Measurement of worker exposure through appropriate monitoring campaign
  6. Preparation of the assessment document for the exposure of workers to carcinogens, mutagens and reprotoxic agents
  7. Training and informing and training of personnel involved in the use of substances under assessment
  8. Introduce any other actions resulting from the exposure assessment

Source: EUR-Lex 

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