The European Biosafety Network, together with the European Federation of Nurses Associations (EFN), and the European Federation of Public Service Unions (EPSU), on behalf of the Stop Cancer At Work (SCAW) campaign has written jointly to the European Commission urging it to support Parliament’s position on the inclusion of hazardous medicinal products (HMPs) in Annex I of the Carcinogens, Mutagens and Reprotoxic Substances Directive (CMRD 6), ahead of the political trilogue meeting on 23 June.
The joint letter, addressed to DG Employment, Social Affairs and Inclusion, sets out why Annex I inclusion is both legally necessary and proportionate and addresses the objections raised by the Commission and Council, which have so far opposed the amendment while Parliament holds firm.
The central argument is one of legal clarity. Despite training requirements, an EU indicative list of HMPs, and published guidance already being in place, HMPs do not appear in the core operative provisions of the CMRD. Without an explicit Annex I entry, binding employer obligations are not unambiguously engaged for the hundreds of thousands of healthcare workers who prepare, administer, and dispose of these substances every day. The result is a persistent implementation gap, one that EBN’s own research has documented.
EBN’s national survey of over 1,000 oncology nurses in Germany, conducted in partnership with the German Oncology Nursing Society (KOK) and published earlier this year, found that just 32% of respondents had access to closed system transfer devices, and 64% had no occupational health monitoring in place. Healthcare workers are not unprotected because the evidence is absent, they are unprotected because the regulatory framework has not yet translated into consistent employer action. Annex I is the mechanism to change that.
The letter notes that HMP regulation at EU level has followed a clear legislative progression, from guidance, to a formal definition, to an indicative list, to mandatory training requirements, and that Annex I inclusion is the logical next step. Because the CMRD is a directive whose transposition varies across Member States, an Annex I entry is the most direct mechanism available to narrow that variation and give national competent authorities a clear basis on which to act.
The three amendments EBN and its co-signatories are asking the Commission to support are: recognition of HMP handling as a work process in Annex I; a formal legal definition of hazardous medicinal products; and reinforced training obligations for exposed workers.
