‘Biobor JF’ – the aircraft fuel preservative essential in order to control microbiological contamination
Background | Product use and characteristics -
The microbiological contamination of aircraft fuel tanks and fuel systems can result in failures of the aircraft engine and jeopardize its safety, thus endangering passengers and crew. Microbiological contamination is a consequence of microorganisms’ build-up when aircrafts are parked and/or stored for periods of time, but which may be prevented by the introduction of ‘Biobor JF’ preservative in the fuel system.
The only alternative biocidal product recommended by aircraft and engine manufacturers for the treatment of microbiological contamination (Kathon™ FP 1.5) was withdrawn from the market in March 2020 due to safety incidents that occurred after the treatment with that product. Consequently, ‘Biobor JF’ is the only chemical treatment available, and since significant additional numbers of aircrafts are currently in long term parking and/or storage because of the effects of COVID-19 on global air traffic, the use of this product is necessary to the industry to safeguard public safety and cannot be attained through another biocidal product or by other means.
Background | Reason for derogation with timelines -
The two biocidal active substances contained in the formulation of ‘Biobor JF’ are
2,2'-(1-methyltrimethylenedioxy)bis-(4-methyl-1,3,2-dioxaborinane) (CAS no. 2665-13-6) and
As these active substances are not listed in Annex II to Commission Delegated Regulation (EU) No 1062/2014, they are 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. This implies that Article 89 of that Regulation therefore does not apply to those substances, and they must be assessed and approved before biocidal products containing them can be authorized also at national level.
Since this assessment process relies on a thorough and lengthy evaluation that may take years to be finalized, an interim solution was needed, and still is, for the immediate use of ‘Biobor JF’ by local stakeholders.
The approach adopted by various EU Member States, including by the MCCAA as the Maltese Competent Authority, was placing on the market through an Article 55 derogation;
The first derogation was granted locally on the 13th of May 2020 for 180 days until 9th of November 2020,
On receipt of a reasoned request from the MCCAA, the Commission allowed an extension for a further 550 days until 14th of May 2022.
Action required by stakeholders -
Even though the maximum derogatory period permitted by the provisions of Article 55 for making available on the market and use of ‘Biobor JF’ has elapsed, the Commission is conscious of the fact that this matter is still ongoing and is critical to the aviation industry, especially to Malta as an island that is highly dependent on air traffic for both passenger and cargo transportation.
The Commission has now informed EU Member States that another exceptional derogation will be permitted up to the 31st of October 2022, and the MCCAA is doing its utmost to support local stakeholders in the aviation industry and ensure continuity. In this regard, the MCCAA requires each single entity interested in making use of ‘Biobor JF’ in Malta to submit a Notification application as confirmation that such derogation is necessary for their operations locally.
Respective companies are kindly being requested to fill in and submit the following online form together with any supporting documentation about the product in question such as but not limited to label, safety data sheet, and technical data sheet.
The renewal fee for those companies which had already registered product with the MCCAA in the past is €50.
The fee for those companies which are going to apply for product registration with the MCCAA for the first time is €100. The MCCAA’s bank details may be viewed in the ‘PAYMENT DETAILS’ section of the e-form and proof of payment must be uploaded together with the application.
If your company needs a derogation for use of ‘Biobor JF’ beyond the 14th of May 2022, deadline for applying is the 13th of May.
For more information do not hesitate to contact the MCCAA’s biocidal products helpdesk at through e-mail at firstname.lastname@example.org .