The European Commission has approved the Polish Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products to extend the use of Biobor JF, a crucial biocidal product, until 13 March 2025. This decision, detailed in Commission Implementing Decision (EU) 2023/2634 dated 27 November 2023, comes as a significant step in ensuring air transport safety.
Background and Necessity
In March 2023, Poland authorised the use of Biobor JF for professional users to treat microbial contamination in aircraft fuel tanks and systems. This contamination, primarily by bacteria, mould, and yeast, can severely impact aircraft engine performance and safety. Given the absence of viable alternatives and the critical role of Biobor JF in maintaining operational safety, the extension was deemed necessary.
Biobor JF contains unique active substances, not yet fully evaluated under EU biocidal regulations. However, its effectiveness in controlling microbial contamination has been unparalleled, especially since the withdrawal of alternative products like Kathon™ FP 1.5 in 2020 due to safety concerns.
The manufacturer of Biobor JF is working towards EU approval, with an application expected in early 2024. This process, while essential for long-term authorization, is time-consuming, necessitating the current extension.
Safety and Operational Concerns
With no other biocidal product meeting the required safety and efficiency standards, and mechanical treatments posing risks, the Commission recognized the urgent need for this extension. The lack of effective microbial control in aircraft fuel systems poses a significant risk to air transport safety.
Implications and Actions
This decision underscores the critical balance between regulatory compliance and operational safety in the aviation sector. Stakeholders are advised to monitor developments closely and prepare for future regulatory changes while prioritising safety.
The European Commission’s decision is a proactive measure ensuring the safety of air transport, reflecting the complexity of balancing regulatory standards with practical safety needs in the aviation industry.
