Date: 2021-01-18Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2021/32 of 13 January 2021 concerning the extension of the action taken by the Environment Agency of Luxembourg 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) 13) (Only the French text is authentic)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Implementing Decision EU 2021/32 allows the Environment Agency of Luxembourg to extend the permission for making available and using the biocidal product BIOBOR JF for antimicrobial treatment of aircraft fuel systems. This extension is valid until May 5, 2022, and addresses concerns about air transport safety due to microbiological contamination exacerbated by parked aircraft during the COVID-19 pandemic. The decision is applicable retroactively from November 1, 2020.
Key Points / Main Content:
* **Extension of Biocidal Product Use:**
* The Environment Agency of Luxembourg can extend the permission for making available and using BIOBOR JF.
* BIOBOR JF is for antimicrobial treatment of fuel tanks and fuel systems of parked aircraft.
* The extension is for professional users only.
* The extension is permitted until May 5, 2022.
* **Justification for the Extension:**
* The extension is necessary to protect public health and air transport safety.
* Microbiological contamination of aircraft fuel systems can lead to engine malfunctions.
* The COVID-19 pandemic and flight restrictions have increased the risk of contamination due to parked aircraft.
* An alternative biocidal product was withdrawn due to engine anomalies.
* Mechanical treatments are unsuitable for the Luxembourgish airline fleet.
* **BIOBOR JF Active Substances:**
* BIOBOR JF contains active substances not yet approved at the national or Union level.
* The manufacturer is expected to apply for approval of the active substances in early 2021.
* **Retroactive Effect:**
* The decision applies retroactively from November 1, 2020.
Impact Analysis:
* **Environment Agency of Luxembourg**
* Impact: The Agency is authorized to extend the permission for the use of BIOBOR JF.
* Action Required: Implement the extension of the permission for BIOBOR JF according to the conditions specified in the decision.
* **Professional Users of BIOBOR JF**
* Impact: They can continue using BIOBOR JF for antimicrobial treatment of aircraft fuel systems until May 5, 2022.
* Action Required: Comply with the regulations and conditions set by the Environment Agency of Luxembourg for the use of BIOBOR JF.
* **Aircraft and Engine Manufacturers**
* Impact: Their recommended treatment is available for use.
* Action Required: None explicitly mentioned in the document.
* **European Commission**
* Impact: Oversees and approves the extension of the action taken by Luxembourg.
* Action Required: Monitor the situation and the progress of the application for approval of the active substances in BIOBOR JF.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
Environment Agency of Luxembourg: The competent authority in Luxembourg responsible for environmental matters, including biocidal product regulation.
BIOBOR JF: A biocidal product used for the antimicrobial treatment of fuel tanks and fuel systems, especially in parked aircraft.
Regulation EU No 528/2012: A European Union regulation concerning the making available on the market and use of biocidal products.
Commission Delegated Regulation EU No 1062/2014: A European Union regulation on the work programme for the systematic examination of all existing active substances contained in biocidal products.
COVID-19 pandemic: The global pandemic of Coronavirus disease 2019, which led to flight restrictions and increased microbiological contamination in aircraft fuel tanks.
Brussels: The de facto capital city of the European Union, where the decision was made.
Stella KYRIAKIDES: Member of the European Commission.
18.1.2021 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 U nion L 15/7
COMMISSION IMPLEMENTING DECISION (EU) 2021/32
of 13 January 2021
concerning the extension of the action taken by the Environment Agency of Luxembourg 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) 13)
(Only the French 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 products1, and in particular the third subparagraph of Article 55(1)
thereof,
Whereas:
(1) On 4 May 2020 the Environment Agency of Luxembourg (the ‘competent authority’) adopted a decision
(subsequently amended on 19 June 2020 and 7 October 2020) in accordance with the first subparagraph of
Article 55(1) of Regulation (EU) No 528/2012 to permit until 31 October 2020 the making available and use by
professional users of the biocidal product BIOBOR JF for the antimicrobial treatment of fuel tanks and fuel systems
of parked aircraft (‘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 the second subparagraph
of Article 55(1) of that Regulation.
(2) According to the information provided by the competent authority, the action was necessary in order to protect
public health. 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 included in the work programme laid down in
Annex II to Commission Delegated Regulation (EU) No 1062/20142 for the systematic examination of all existing
active substances contained in biocidal products referred to in Regulation (EU) No 528/2012, they have to be
assessed and approved before biocidal products containing them can be authorised at national or Union level.
(4) On 16 October 2020, the Commission received a reasoned request from the competent authority to extend the
action in accordance with the third subparagraph of Article 55(1) 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 and the argument that BIOBOR JF is essential
in order to control such microbiological contamination.
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 15/8 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 an Union 18.1.2021
(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 was
withdrawn from the market in March 2020 on account of severe engine behaviour anomalies noticed after the
treatment with that product.
(6) As indicated by the competent authority, the mechanical treatment of microbiological contamination of aircraft fuel
tanks and fuel systems entails setting up of regular draining operations and microbiological testing of drainage
samples, requiring additional staff and the establishment of complex procedures for sampling and laboratory testing
of samples, which do not appear to be suitable for the Luxembourgish airline fleet. Moreover, the manual cleaning of
contaminated tanks – needed if contamination is detected – would expose workers to toxic gases and should be
avoided.
(7) According to the information provided by the competent authority, 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 early 2021. The approval of the active substances and subsequent authorisation of the
biocidal product would represent a permanent solution for the future, but a significant amount of time will be
needed for the completion of those procedures.
(8) As the lack of control of microbiological contamination of aircraft fuel tanks and fuels 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 appropriate to allow the competent authority to extend the action for a period not exceeding 550 days
starting from the day following the expiry of the initial period of 180 days permitted in the decision of the
competent authority of 4 May 2020 as amended on 7 October 2020.
(9) Considering that the action has lapsed since 1 November 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 Environment Agency of Luxembourg may extend until 5 May 2022 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 fuel tanks and
fuel systems of parked aircraft.
Article 2
This Decision is addressed to the Environment Agency of Luxembourg.
It shall apply from 1 November 2020.
Done at Brussels, 13 January 2021.
For the Commission
Stella KYRIAKIDES
Member of the Commission