Inclusion of reprotoxic substances in the scope of the new Carcinogens, Mutagens and Reprotoxins Directive (CMRD). For 12 of these substances, a binding  occupational maximum exposure level limit value will be introduced in Annex III of the Directive.

Inclusion of hazardous medicinal products (HMPs) in two key clauses in the new Directive, whereby the European Commission is required to:

  • Prepare guidelines for handling HMPs, particularly in hospitals, no later than 31 December 2022.
  • Develop a definition and establish an indicative list of HMPs, no later than one year after the transposition of this Directive.
  • Workers who deal with HMPs will receive sufficient and appropriate training, to better protect workers in the healthcare sector.

In addition a recital and a joint declaration in the Official Journal of the EU will provide clarification that the HMPs containing carcinogenic, mutagenic and reprotoxic substances fall under the scope of the Directive.

The Commission is also obliged to present an Action Plan by 2022 for the inclusion of additional 25 substances without delay and also launch the process to define the upper and lower risk levels as a part the European Parliament demand for revision of the methodology for establishing OELs that would better take into consideration adverse health effects.

There is currently no technical information on whether a particular reprotoxic substance is threshold or non-threshold.  However, employers will have to put in place strict minimisation principles anyway which will not jeopardise the application of the CMD requirements for the inclusion of reprotoxic substances.