Commission Implementing Decision (EU) 2026/1104 of 22 May 2026 concerning the extension of the action taken by the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products permitting the making available on the market and use of the biocidal product Biobor JF in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (notified under document C(2026) 3259)

Official Journal EN of the European Union L series 2026/1104 26.5.2026 COMMISSION IMPLEMENTING DECISION(EU) 2026/1104 of 22 May 2026 concerning the extension of the action taken by the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products permitting the making available on the market and use of the biocidal product Biobor JF in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (notified under document C(2026) 3259) (Only the Polish text is authentic) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products(1), and in particular Article 55(1), third subparagraph, thereof,

Whereas:

(1) On 23 October 2025, the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (‘the Polish competent authority’) adopted a decision in accordance with Article 55(1), first subparagraph, of Regulation (EU) No 528/2012 to permit until 21 April 2026, the making available on the market and use by professional users of the biocidal product Biobor JF for the antimicrobial treatment of aircraft fuel tanks and fuel systems (‘the action’). The Polish competent authority informed the Commission and the competent authorities of the other Member States of the action and the justification for it, in accordance with Article 55(1), second subparagraph, of that Regulation.

(2) According to the information provided by the Polish competent authority, the action was necessary in order to protect public health. Microbiological contamination of aircraft fuel tanks and fuel systems is caused by micro- organisms, such as bacteria, mould and yeast, that grow in stagnant water and feed off hydrocarbons in the fuel at the fuel-to-water interface. If left untreated, the microbiological contamination of aircraft fuel tanks and fuel systems can lead to malfunctions of the aircraft engine and endanger the aircraft airworthiness, thereby endangering the safety of passengers and crew. The detection, prevention and treatment of microbiological contamination are therefore crucial in order to avoid operational problems in aircraft.

(3) Biobor JF contains reaction mass of 2,2'-[(1-methylpropane-1,3-diyl)bis(oxy)]bis[4-methyl-1,3,2-dioxaborinane] and 2,2'-oxybis(4,4,6-trimethyl-1,3,2-dioxaborinane) as active substance. Biobor JF is a biocidal product of product- type 6 (preservatives for products during storage), as defined in Annex V to Regulation (EU) No 528/2012. Reaction mass of 2,2'-[(1-methylpropane-1,3-diyl)bis(oxy)]bis[4-methyl-1,3,2-dioxaborinane] and 2,2'-oxybis(4,4,6-tri­ methyl-1,3,2-dioxaborinane) has not been evaluated for use in biocidal products of product-type 6. As that substance is not listed among the substance/product-type combinations included in the review programme on 17 March 2022, as set out in Annex II to Commission Delegated Regulation (EU) No 1062/2014(2), it is not included in the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012. Article 89 of Regulation (EU) No 528/2012 allowing Member States to continue to apply their current system or practice of making available on the market or using a given biocidal product therefore does not apply to that active substance, which has to be assessed and approved before biocidal products containing it can be authorised also at national level.

(4) On 14 January 2026, the Commission received a reasoned request from the Polish competent authority to allow the extension of the action in accordance with Article 55(1), third subparagraph, of Regulation (EU) No 528/2012. The reasoned request was based on concerns that air transport safety might continue to be endangered by microbiological contamination of aircraft fuel tanks and fuel systems and on the argument that Biobor JF is essential in order to control such microbiological contamination.

(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2) Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1, ELI: http://data.europa.eu/eli/reg_del/2014/1062/oj).

ELI: http://data.europa.eu/eli/dec_impl/2026/1104/oj 1/2EN OJ L, 26.5.2026

(5) According to the information provided by the Polish competent authority, the only alternative biocidal product recommended by aircraft and aircraft engine manufacturers for the treatment of microbiological contamination, namely, Kathon™ FP 1.5, was withdrawn from the market in March 2020 due to severe behaviour anomalies in aircraft engines that were noticed after the treatment of aircraft engines with that product. Biobor JF is therefore the only available product for that use recommended by aircraft and aircraft engine manufacturers.

(6) As indicated by the Polish competent authority, the mechanical treatment of microbiological contamination of aircraft fuel tanks and fuel systems is not always possible and the procedures recommended by engine manufacturers require the treatment with a biocidal product even when mechanical cleaning is possible. Moreover, mechanical treatment would expose workers to toxic gases and should therefore be avoided.

(7) The manufacturer of Biobor JF has taken steps to seek an authorisation of the product. An application for approval of the active substance that Biobor JF contains was submitted in June 2025 to the European Chemicals Agency. The approval of the active substance and the authorisation of the biocidal product would constitute a long-term solution, but a significant amount of time is needed for the completion of the approval and authorisation procedures.

(8) The lack of control of microbiological contamination of aircraft fuel tanks and fuel systems might endanger air transport safety, and that danger cannot be adequately controlled by using another biocidal product or by any other means. It is therefore appropriate to allow the Polish competent authority to extend the action beyond 21 April 2026.

(9) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS DECISION:

Article 1 The Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products may extend until 24 October 2027 the action permitting the making available on the market for, and use by, professional users of the biocidal product Biobor JF for the antimicrobial treatment of aircraft fuel tanks and fuel systems.

Article 2 This Decision is addressed to the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Done at Brussels, 22 May 2026.

For the Commission Olivér VÁRHELYI Member of the Commission 2/2 ELI: http://data.europa.eu/eli/dec_impl/2026/1104/oj