On 3 June 2025, the European Commission adopted Decision (EU) 2025/1074, which formally rejects the approval of ethylene oxide as an active substance for use in biocidal products of product-type 2 those used as disinfectants and algaecides not intended for direct human or animal application—under Regulation (EU) No 528/2012.
The assessment, led by Norway as the evaluating Member State, concluded that ethylene oxide meets exclusion criteria set out in the regulation and should generally not be approved unless specific derogation conditions apply. However, the uses proposed in the application such as for sterilising medical devices, medicinal products, and related packaging are regulated under other EU frameworks, specifically Regulation (EU) 2017/745 on medical devices and EU legislation on medicinal products, rather than the Biocidal Products Regulation.
As these intended uses do not fall under the scope of Regulation (EU) No 528/2012, and no alternative biocidal uses were submitted that would meet the criteria, the Commission decided that ethylene oxide should not be approved for product-type 2.
Key Takeaway:
Ethylene oxide remains allowed for certain sterilisation purposes within the medical and pharmaceutical sectors but is not authorised as a biocidal active substance for product-type 2 under current EU biocides legislation.
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