Will reprotoxic substances and dangerous medicinal products be included in the future?

SW – 04/2021

The European Parliament’s committee on Employment and Social Affairs has adopted its position on the fourth update of Directive 2004/37/EU about protecting workers from the risks related to exposure to carcinogens or mutagens. In March 2021, the committee members voted in favour of stricter EU rules to better protect workers from exposure to carcinogens, mutagens and reprotoxic substances in the workplace. They decided to begin negotiations with the Council at their meeting held on April 13, 2021.

The EU Commission presented its proposal for a fourth amendment to the directive on protection against carcinogens or mutagens at work in September 2020 (see report 10/2020). In November, the Council agreed on its position for the negotiations with the European Parliament.

Modification of limits

The draft amendment provides for new or reduced limits for exposure to three different substances at the workplace. These are new limits for acrylonitrile and nickel compounds and a further reduction in the benzene limit. This should help protect one million workers and help prevent more than 1,700 cases of work-related illness over the next 60 years.

Reprotoxic substances

MEPs also voted to extend the scope of the Directive to include reprotoxic substances. These substances may cause adverse effects on development, fertility and reproduction. According to the MEPs, the Commission should present an action plan by the end of 2021 to lay down limits for a number of reprotoxic substances, such as lead, lead compounds and mercury.

Dangerous medicinal products

Finally, the MEPs called for dangerous medicinal products to be included in the scope of the directive. 12.7 million workers, which includes 7.3 million nurses, are potentially exposed to dangerous medicines in the workplace in the health sector. Handling, preparing and administering these medicinal products exposes health professionals to high health risks. The likelihood of developing cancer is three times higher. The committee would like the EC to draw up, by March 2022, a definition of 'dangerous medicinal products' and a list of substances, preparations or processes covered by the term 'carcinogens'. It also aims to draft guidelines and standards of practice for preparing, administering and disposing of dangerous medicinal products by December 2022.


The fight against cancer is a priority for the EU Commission during the current term of office. Cancer is the most common work-related cause of death in the EU, accounting for about 52% of annual work-related deaths. The EU Commission has therefore included occupational cancers in a separate chapter on reducing exposure to pollutants and radiation in the "Prevention" field of action in its European plan to combat cancer, which was presented in February 2021.