Ethylene oxide is primarily used to sterilise medical devices before they hit the market. It was first approved under the BPR in 2020, with the European Chemicals Agency's (ECHA) Committee on Biocidal Products (BPC) acknowledging the substance's effectiveness. However, the BPC also raised concerns about potential risks to staff working in sterilisation facilities and the general public, as the chemical is classified as carcinogenic, mutagenic and toxic to reproduction (CMR).
Despite these concerns, at the time of its initial approval, no viable alternatives to ethylene oxide had been identified, underscoring the complexity of its use and regulation.
The current decision to withdraw approval relates specifically to product-type two biocidal products, which include disinfectants and algaecides that are not intended for direct application to humans or animals. The Commission's review concluded that all documented uses of ethylene oxide presented by the applicants fall outside the scope of the BPR and should instead be regulated under EU law relating to medicinal products and medical devices.
The Commission's draft implementing decision detailing this change is a five-page document written in English, and underlines the Commission's continued commitment to protecting public health and harmonising market regulations across the EU.
The proposed date for adoption of this decision is February 2025, and it is expected to enter into force 20 days after its publication in the Official Journal of the European Union. Implementation for affected products is expected to begin 12 months after adoption. Stakeholders and the public are invited to submit their comments on this decision by 60 January as part of a 20-day comment period following notification to the World Trade Organization (WTO).
