The European Parliament and the Council of the EU failed to reach an interinstitutional agreement on the draft directive on carcinogens and mutagens during the negotiation meeting held on the evening of Wednesday, 17 November, mainly due to the issue of including hazardous drugs in the annex.
Despite a significant relaxation of the negotiating mandate obtained by the Slovenian Presidency of the Council of the EU—notably regarding the inclusion of reprotoxic substances (see EUROPE 12832/22)—co-legislators did not manage to make progress on the issue of workers’ exposure to hazardous medicinal products (HMPs) and, in particular, its inclusion in Annex I of the directive. Yet, for the European Parliament, this is a very important part of their mandate—a “red line” even.
Because of this blockage, the question of taking a risk-based approach to estimate exposure levels was not discussed in depth, even though the Council of the EU would, in all likelihood, not be able to forge ahead on this point given there is no consensus among Member States on this approach. The questions of whether action plans to include additional substances should be included and whether a revision clause should be added for certain substances also remain.
A date for a third negotiation meeting has not been agreed upon. Some believe that the French Presidency, which will take charge at the beginning of 2022, could take up the torch. This could be good news given the country already has national measures notably for hazardous drugs, we were told. (Original version in French by Pascal Hansens)