Date: 2021-08-10Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2021/1315 of 6 August 2021 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 Article 55(1) of Regulation (EU) No 528/2012 of the European Parliament and of the Council (notified under document C(2021) 5821) (Only the Polish text is authentic)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Implementing Decision EU 2021/1315 extends the permission granted to the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products to allow the making available on the market and use of the biocidal product Biobor JF for antimicrobial treatment of aircraft fuel systems. This extension is until November 6, 2022, and addresses concerns about microbiological contamination exacerbated by the COVID-19 pandemic. The decision has retroactive effect from May 6, 2021.
Key Points / Main Content:
Extension of Biobor JF Authorization:
* The Polish Office is permitted to extend the availability and use of Biobor JF until November 6, 2022.
* This extension applies to the use of Biobor JF by professional users for preventive and curative antimicrobial treatment of aircraft fuel tanks and fuel systems.
Justification for Extension:
* The extension is necessary to protect public health due to the risk of microbiological contamination in aircraft fuel systems, which can lead to engine malfunctions and endanger airworthiness.
* COVID-19 related flight restrictions and the resulting immobility of aircraft exacerbate the risk of microbiological contamination.
* The previously recommended alternative, Kathon FP 1.5, was withdrawn from the market.
* Manual removal of contamination is not always feasible and poses risks to workers.
Active Substance Status:
* Biobor JF contains active substances not yet included in the EU's work programme for systematic examination, necessitating approval before national authorization.
Timeline:
* The decision applies retroactively from May 6, 2021.
* An application for approval of the active substances in Biobor JF is expected in mid-2022.
Impact Analysis:
Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Impact: The office is authorized to extend the permission for Biobor JF's availability and use.
Action Required: Implement the decision to extend the permission until November 6, 2022.
Professional Users of Biobor JF:
Impact: Can continue to use Biobor JF for antimicrobial treatment of aircraft fuel systems until November 6, 2022.
Action Required: Continue using Biobor JF as needed for antimicrobial treatment.
Aircraft Passengers and Crew:
Impact: Benefits from enhanced air transport safety due to controlled microbiological contamination.
Action Required: No direct action required.
Biobor JF Manufacturer:
Impact: The manufacturer's product can continue to be available for use in the EU market through the extended period.
Action Required: Continue with the application for approval of the active substances expected to be submitted in mid-2022.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
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.
Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: The competent authority in Poland responsible for the registration of medicinal products, medical devices, and biocidal products.
Biobor JF: A biocidal product used for the preventive and curative antimicrobial treatment of aircraft fuel tanks and fuel systems.
COVID-19: The infectious disease caused by the SARS-CoV-2 virus, responsible for the COVID-19 pandemic.
Commission Delegated Regulation EU No 1062/2014: Commission Delegated Regulation 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.
Brussels: The de facto capital city of the European Union, located in Belgium. Place where the decision was made.
Stella Kyriakides: Member of the European Commission.
10.8.2021 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 287/11
COMMISSION IMPLEMENTING DECISION (EU) 2021/1315
of 6 August 2021
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 Article 55(1) of Regulation (EU)
No 528/2012 of the European Parliament and of the Council
(notified under document C(2021) 5821)
(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 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 6 November 2020, the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal
Products (‘the competent authority’) adopted a decision to permit, in accordance with Article 55(1), first
subparagraph, of Regulation (EU) No 528/2012, the making available on the market for, and use by, professional
users of the biocidal product Biobor JF for the preventive and curative antimicrobial treatment of aircraft fuel tanks
and fuel systems until 5 May 2021 (‘the action’). The competent authority informed the Commission and the
competent authorities of the other Member States of its 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, as the microbiological contamination of aircraft fuel tanks and fuel systems can lead to malfunctions
of the aircraft engine and endanger its airworthiness, thus putting at risk 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 8 March 2021, the Commission received a reasoned request from the competent authority to allow the extension
of the action in accordance with the 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 5 May 2021and the claim 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 287/12 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 10.8.2021
(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 (Kathon™
FP 1.5) was withdrawn from the market in March 2020 due to severe engine anomalies noticed after the treatment
with that product.
(6) As indicated by the competent authority, the alternative procedure for treating an existing microbiological
contamination is manual removal in-tank, following defueling and purging of the aircraft. Manual removal may
however not always be possible alongside other maintenance actions that are required when an aircraft is parked or
stored for long periods. Moreover, the manual cleaning of contaminated tanks 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 5 May 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 Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products may extend the action to
permit the making available on the market for, and use by, professional users of the biocidal product Biobor JF for the
preventive and curative antimicrobial treatment of aircraft fuel tanks and fuel systems until 6 November 2022.
Article 2
This Decision is addressed to the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal
Products.
It shall apply from 6 May 2021.
Done at Brussels, 6 August 2021.
For the Commission
Stella KYRIAKIDES
Member of the Commission