In the context of the fight against cancer in the EU, Royal Decree 612/2024 on the protection of employees from the risks related to exposure to carcinogenic agents at work has brought relevant changes such as the incorporation of protection against reprotoxic agents or the updating of the table of occupational exposure limit values and has reinforced the obligations of companies to train and inform their staff, as well as to keep documentation.


In the communication from the European Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the EU Strategic Framework for Health and Safety at Work 2021-2027, it is highlighted that the main cause of occupational mortality in the European Union (EU) is cancer. According to the data provided in this document, carcinogens contribute to approximately 100,000 occupational cancer deaths per year in the workplace. For this reason, cancer prevention measures at the workplace are included in the Europe’s Beating Cancer Plan and a Roadmap on Carcinogens 2020-2024 was established to implement provisions in the EU that aim to limit the exposure of employees to 26 hazardous substances in the workplace.

The homogenization of criteria in the European Union in relation to the protection of employees against carcinogenic or mutagenic agents at work contributes to an improvement in the protection of people exposed to these agents.

In this context, on July 4, 2024, came into force Royal Decree 612/2024, of July 2, 2024, on the protection of employees against the risks related to exposure to carcinogenic agents at work, which introduces novelties to adapt Royal Decree 665/1997, of May 12, 2024, on the protection of employees from the risks related to exposure to carcinogens at work to Directive (EU) 2022/431 of the European Parliament and of the Council of 9 March 2022, amending Directive 2004/37/EC on the protection of employees from the risks related to exposure to carcinogens or mutagens at work.

We summarize below the main novelties introduced into Spanish legislation by the aforesaid royal decree:

  •  Expansion of the scope of protection: reprotoxic agents are included in the scope of protection, defined as those that may affect sexual function and the fertility and development of offspring.
    The specificities contemplated by this royal decree for reprotoxic agents vary depending on whether these agents have threshold values, i.e., whether they are agents for which there is no safe level of exposure for human health or whether there is such a level below which there is no risk.
  •  Updating of the table of occupational exposure limit values: two new carcinogens are incorporated into the table, establishing the exposure limit values for these: acrylonitrile (present in the textile industry) and nickel compounds (in the metal industry, manufacture of nickel-cadmium batteries, ceramic industry and glass as a pigment). The existing limit value for benzene (present in the production of plastics, synthetic rubber, dyes, resins, raw materials for detergents or pesticides, among others) is also updated.
    The table includes 12 reprotoxic agents, including lead and its inorganic compounds.
  •  Training and information: the training and information provided to the workforce on the risks and protective measures related to exposure to carcinogens and reprotoxic agents is reinforced.
  •  Retention of documents: a five-year period is established for the retention of certain documents related to exposure to reprotoxic agents (results of evaluations including the criteria and procedures used, the methods of measurement, analysis or testing and updated lists of exposed workers), which coincide with the documents that must be kept for 40 years with respect to carcinogenic or mutagenic agents.

Leire Franco Rodríguez