Date: 2021-08-16Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2021/1365 of 11 August 2021 concerning the extension of the action taken by the Croatian Ministry of Health 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) 5929) (Only the Croatian text is authentic)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Implementing Decision EU 2021/1365 permits the Croatian Ministry of Health to extend the availability and use of the biocidal product Biobor JF for antimicrobial treatment of aircraft fuel tanks by professional users until September 2, 2022. This extension addresses concerns about microbiological contamination impacting air transport safety, especially given the withdrawal of an alternative product and the impact of COVID-19 flight restrictions. The decision is effective retroactively from March 1, 2021.
Key Points / Main Content:
Extension of Biobor JF Authorization:
* The Croatian Ministry of Health is authorized to extend the permission for making available on the market and use of Biobor JF.
* Extension is for antimicrobial treatment of aircraft fuel tanks and fuel systems.
* The product is for use by professional users.
* The extension period is until September 2, 2022.
Justification for Extension:
* The extension is necessary to protect public health and air transport safety.
* Microbiological contamination of aircraft fuel poses a risk to engine function and airworthiness.
* COVID-19 flight restrictions exacerbated contamination due to parked aircraft.
* Alternative product, Kathon FP 1.5, was withdrawn due to safety incidents.
* Mechanical treatment is not always feasible and can expose workers to toxic gases.
Active Substances & Future Authorization:
* Biobor JF contains active substances not yet approved under Regulation EU No 528/2012.
* The manufacturer is expected to submit an application for approval of the active substances in mid-2022.
Retroactive Effect:
* The decision applies retroactively from March 1, 2021.
Impact Analysis:
Croatian Ministry of Health:
* Impact: Granted the authority to extend the permission for Biobor JF, and responsible for overseeing its use.
* Action Required: Implement the extension, monitor the use of Biobor JF, and communicate with relevant stakeholders.
Professional Users of Biobor JF:
* Impact: Can continue using Biobor JF for antimicrobial treatment of aircraft fuel tanks until September 2, 2022.
* Action Required: Adhere to proper usage guidelines and safety measures when applying Biobor JF.
Aircraft Passengers and Crew:
* Impact: Benefit from increased air transport safety due to controlled microbiological contamination.
* Action Required: No direct action required.
European Commission:
* Impact: Has made a decision to allow a member state to extend the use of a non-approved biocidal product due to safety concerns.
* Action Required: No direct action required.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
Commission Implementing Decision EU 2021/1365: The title of the specific implementing decision being analyzed.
Croatian Ministry of Health: The national ministry of health of Croatia, which adopted a decision regarding the biocidal product Biobor JF.
Biobor JF: A biocidal product used for antimicrobial treatment of aircraft fuel tanks and fuel systems.
Regulation EU No 528/2012: A regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.
COVID-19: The Coronavirus Disease 2019 pandemic, which led to flight restrictions and aircraft being temporarily parked, an aggravating factor of microbiological contamination.
Kathon FP 1.5: An alternative biocidal product that was withdrawn from the market due to safety incidents.
Brussels: The city where the decision was made.
L 293/32 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 16.8.2021
COMMISSION IMPLEMENTING DECISION (EU) 2021/1365
of 11 August 2021
concerning the extension of the action taken by the Croatian Ministry of Health 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) 5929)
(Only the Croatian 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 31 August 2020 the Croatian Ministry of Health (‘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 for, and use by, professional users of the biocidal product Biobor JF for the antimicrobial treatment of
aircraft fuel tanks and fuel systems until 28 February 2021 (‘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 those substances and they have to be assessed and approved before
biocidal products containing them can be authorised also at national level.
(4) On 3 March 2021, 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 28 February 2021 and 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 safety incidents that occurred 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).16.8.2021 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 293/33
(6) According to the competent authority, the mechanical treatment of microbiological contamination of aircraft fuel
tanks and fuel systems is not always possible and 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) 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 mid-2022. 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 expired on 28 February 2021, 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 Croatian Ministry of Health may extend until 2 September 2022 the action to permit 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 Croatian Ministry of Health.
It shall apply from 1 March 2021.
Done at Brussels, 11 August 2021.
For the Commission
Stella KYRIAKIDES
Member of the Commission