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Fourth Amendment to the Carcinogens and Mutagens Directive

Further to our update in January 2022, the EU Commission has published Directive (EU) 2022/431 - introducing amendments to Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work.

The Act was signed by the co-legislators on 9 March 2022 and published in the Official Journal on 16 March 2022. 

This fourth amendment to the CMD revises the limit values for three key carcinogens: acrylonitrile, nickel and benzene. It also extends requirements to reprotoxic substances and hazardous medicinal products (HMPs).

Healthcare workers who deal with HMPs, half of which are reprotoxic, must receive sufficient and appropriate training on how to handle them safely. The agreed text asks the Commission to develop a definition for, and establish an indicative list of HMPs no later than 5 April 2025 to and prepare guidelines for handling these substances, particularly in hospitals, by the end of 2022.

In addition, the Commission has to present legislative proposals on occupational exposure limit values for 25 substances or groups of substance before the end of 2022 and launch a procedure to reduce the occupational exposure limits for crystalline silica dust.

Member states have two years following adoption to comply with Directive (EU) 2022/431.

Link to Directive

Lead and di-isocyanates

The aim is to revise the current limit values (OEL and BLV) for lead and its compounds and to add a new binding OEL for diisocyanates, reflecting the latest available scientific evidence, so as to ensure the same minimum level of workers protection in all Member States and to contribute to level playing field.

The RAC issued its scientific assessment for lead and its compounds and for diisocyanates  in June 2020.

The two stage Social partners’ consultation was completed and the external study supporting an impact assessment was finalised in August 2021.

Dedicated opinions for the two substances were adopted by the ACSH in the plenary meeting of 24 November 2021. (Doc. 006-216 and Doc. 007-21)

The next step by the Commission will be an impact assessment and initiate subsequent steps in the legislative procedure.

As a reprotoxic, the current OEL and BLV for Lead and its ionic compounds have now been transferred to Directive (EU) 2022/431 - introducing amendments to Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work

The ASCH Opinion on lead and diisocyanates presented to the Commission is publicly available at the following link: ASCH Opinions