European Commission to Withdraw Approval for Ethylene Oxide in Biocidal Products

The European Commission has announced its intention to withdraw approval for the use of ethylene oxide as a surface disinfectant in biocidal products, citing that the chemical's applications do not align with the scope of the Biocidal Products Regulation (BPR). This decision is set to impact the regulatory status of ethylene oxide under the EU's stringent health and environmental standards.

Ethylene oxide is primarily used for sterilizing medical devices before they enter the market. It was previously approved under the BPR in 2020, with the European Chemicals Agency’s (ECHA) Biocidal Products Committee (BPC) acknowledging the substance's effectiveness. However, the BPC also raised concerns about potential risks to workers in sterilization facilities and the general public, given the chemical's classification as carcinogenic, mutagenic, and toxic for reproduction.

Despite these concerns, at the time of its initial approval, no viable alternatives to ethylene oxide were identified, which underscored the complexity of its use and regulation.

The current decision to withdraw approval pertains specifically to product-type two biocidal products, which include disinfectants and algaecides not intended for direct application to humans or animals. The Commission's review concluded that all documented uses of ethylene oxide submitted by applicants fell outside the BPR's scope and instead should be regulated under EU legislation concerning medicinal products and medical devices.

The draft Commission Implementing Decision, which details this change, is a five-page document written in English, and it underscores the Commission's ongoing commitment to protecting public health and harmonizing market regulations within the EU.

The proposed date for the adoption of this decision is February 2025, with an anticipated entry into force 20 days following its publication in the Official Journal of the EU. Implementation for the affected products is expected to begin 12 months after adoption. Stakeholders and the public are invited to submit their comments on this decision until January 20, as part of a 60-day comment period following the notification to the World Trade Organization (WTO).

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