Date: 2021-05-10Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2021/754 of 4 May 2021 concerning the extension of the action taken by the Estonian Health Board permitting the making available on the market and use of the biocidal product Biobor JF in accordance with Article 55(1) of Regulation (EU) No 528/2012 of the European Parliament and of the Council (notified under document C(2021) 3032) (Only the Estonian text is authentic)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Implementing Decision (EU) 2021/754 extends the authorization for the Estonian Health Board to permit the use of the biocidal product Biobor JF for antimicrobial treatment of aircraft fuel systems. This extension is until June 20, 2022, and addresses concerns about microbiological contamination impacting air transport safety. The decision is retroactive, applying from December 17, 2020.
Key Points / Main Content:
Extension of Biobor JF Authorization:
* The Estonian Health Board is permitted to extend the availability and use of Biobor JF for professional users.
* The permitted use is specifically for antimicrobial treatment of aircraft fuel tanks and fuel systems.
* The extension is valid until June 20, 2022.
Justification for Extension:
* The extension is necessary to protect public health due to the risk of microbiological contamination in aircraft fuel systems.
* COVID-19 flight restrictions and aircraft immobility exacerbate the contamination risk.
* Alternative biocidal products are either unavailable or have caused issues.
* Mechanical treatment alone is insufficient and potentially hazardous.
Active Substances and Future Authorization:
* Biobor JF contains active substances not yet approved under Regulation (EU) No 528/2012.
* The manufacturer is expected to apply for approval of these active substances.
Retroactive Effect:
* The decision applies retroactively from December 17, 2020, following the previous authorization's expiration.
Impact Analysis:
Estonian Health Board:
* Impact: Authorized to extend the availability and use of Biobor JF, ensuring continued air transport safety.
* Action Required: Implement the extension, allowing professional users to access and use Biobor JF until June 20, 2022.
Professional Users of Biobor JF:
* Impact: Continued access to Biobor JF for antimicrobial treatment of aircraft fuel systems.
* Action Required: Continue using Biobor JF as needed for aircraft fuel system maintenance until June 20, 2022, in accordance with the extended authorization.
European Commission:
* Impact: Oversees and approves the extension, ensuring compliance with Regulation (EU) No 528/2012.
* Action Required: Monitor the situation and the manufacturer's progress towards regular authorization of Biobor JF.
Aircraft Passengers and Crew:
* Impact: Increased safety due to the controlled microbiological contamination of aircraft fuel tanks and fuel systems.
* Action Required: None.
Aircraft and Engine Manufacturers:
* Impact: Continued availability of a recommended solution for microbiological contamination, albeit temporarily.
* Action Required: Monitor the situation and potentially re-evaluate treatment recommendations as the regulatory landscape evolves.
Key Entities Referenced
Estonian Health Board: The competent authority in Estonia that adopted a decision to permit the making available on the market and use of the biocidal product Biobor JF.
Regulation EU No 528/2012: Regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.
Biobor JF: A biocidal product used for the antimicrobial treatment of aircraft fuel tanks and fuel systems.
Commission Implementing Decision EU 2021/754: The decision concerning the extension of the action taken by the Estonian Health Board permitting the making available on the market and use of the biocidal product Biobor JF.
COVID-19 pandemic: The global pandemic that led to flight restrictions and the temporary parking of numerous aircraft, aggravating the microbiological contamination of aircraft fuel tanks and fuel systems.
Stella KYRIAKIDES: Member of the European Commission.
Brussels: The location where the Commission Implementing Decision EU 2021/754 was adopted.
Kathon FP 1.5: An alternative biocidal product, recommended by aircraft and engine manufacturers, that was withdrawn from the market due to severe engine behaviour anomalies.
10.5.2021 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 163/3
COMMISSION IMPLEMENTING DECISION (EU) 2021/754
of 4 May 2021
concerning the extension of the action taken by the Estonian Health Board permitting the making
available on the market and use of the biocidal product Biobor JF in accordance with Article 55(1) of
Regulation (EU) No 528/2012 of the European Parliament and of the Council
(notified under document C(2021) 3032)
(Only the Estonian 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 2012concerning
the making available on the market and use of biocidal products(1), and in particular Article 55(1), third subparagraph,
thereof,
Whereas:
(1) On 19 June 2020 the Estonian Health Board (‘the competent authority’) adopted a decision in accordance with
Article 55(1), first subparagraph, of Regulation (EU) No 528/2012 to permit 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 until 16 December 2020(‘the action’). The competent authority informed the Commission and the
competent authorities of the other Member States about 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 competent authority, the action was necessary in order to protect
public health. The microbiological contamination of aircraft fuel tanks and fuel systems can lead to malfunctions of
the aircraft engine and endanger its airworthiness, thus endangering the safety of passengers and crew. The
COVID-19 pandemic and the ensuing flight restrictions led to numerous aircraft being temporarily parked. The
immobility of aircraft is an aggravating factor of microbiological contamination.
(3) Biobor JF contains 2,2’-(1-methyltrimethylenedioxy)bis-(4-methyl-1,3,2-dioxaborinane) (CAS number 2665-13-6)
and 2,2’-oxybis (4,4,6-trimethyl-1,3,2-dioxaborinane) (CAS number 14697-50-8), active substances for use in
biocidal products of product-type 6 as preservatives for products during storage as defined in Annex V to
Regulation (EU) No 528/2012. As those active substances are not listed in Annex II to Commission Delegated
Regulation (EU) No 1062/2014(2), 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. Article 89
of that Regulation therefore does not apply to them and they have to be assessed and approved before biocidal
products containing them can be authorised also at national level.
(4) On 16 December 2020, the Commission received a reasoned request from the competent authority to extend the
action in accordance with Article 55(1), third subparagraph, of Regulation (EU) No 528/2012. The reasoned request
was made on the basis of concerns that air transport safety might continue to be endangered by microbiological
contamination of aircraft fuel tanks and fuel systems after 16 December 2020and the claim that Biobor JF is essential
in order to control such microbiological contamination.
(5) According to the information provided by the competent authority, 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 severe engine behaviour anomalies noticed after the
treatment with that product.
(1) OJ L 167, 27.6.2012, p. 1.
(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).L 163/4 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union 10.5.2021
(6) The mechanical treatment of microbiological contamination of aircraft fuel tanks and fuel systems is not always
possible and agreed aviation procedures 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) According to the information available to the Commission, the manufacturer of Biobor JF has taken steps towards
the regular authorisation of the product and an application for approval of the active substances it contains is
expected to be submitted in the near future. The approval of the active substances and subsequent authorisation of
the biocidal product would constitute a permanent solution for the future, but a significant amount of time would
be needed for the completion of those procedures.
(8) The lack of control of microbiological contamination of aircraft fuel tanks and fuel systems might endanger the air
transport safety and that danger cannot be adequately contained by using another biocidal product or by other
means It is therefore appropriate to allow the competent authority to extend the action.
(9) Considering that the action has expired on 16 December 2020, this Decision should have retroactive effect.
(10) 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 Estonian Health Board may extend the action to permit 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 until 20 June 2022.
Article 2
This Decision is addressed to the Estonian Health Board.
It shall apply from 17 December 2020.
Done at Brussels, 4 May 2021.
For the Commission
Stella KYRIAKIDES
Member of the Commission