Commission Implementing Decision (EU) 2025/2299 of 14 November 2025 postponing the expiry date of the approval of Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 for use in biocidal products of product-type 18 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2025-11-14
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, insecticide, market approval








L_202502299EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/2299


18.11.2025







            COMMISSION IMPLEMENTING DECISION (EU) 2025/2299
of 14 November 2025
         
postponing the expiry date of the approval of Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 for use in biocidal products of product-type 18 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)


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 products (1), and in particular Article 14(5) thereof,


After consulting the Standing Committee on Biocidal Products,

Whereas:







(1)



Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) as an active substance for use in biocidal products of product-type 18. Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved until 30 September 2023 under that Regulation subject to the conditions set out in Annex I to Directive 98/8/EC.












(2)


On 30 March 2022, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 for use in biocidal products of product-type 18 (‘the application’).












(3)


On 2 February 2023, the evaluating competent authority of Italy informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the application was necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.












(4)


The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.












(5)


Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.












(6)


Commission Implementing Decision (EU) 2023/1085 (3) postponed the expiry date of the approval of Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 for use in biocidal products of product-type 18 to 31 March 2026, in order to allow sufficient time for the examination of the application.












(7)


On 13 June 2025, the evaluating competent authority informed the Commission that the evaluation is delayed due to additional studies needed by the authority to complete the evaluation. The evaluating competent authority expects to submit the renewal assessment report to the Agency in the first quarter of 2026.












(8)


Consequently, for reasons beyond the control of the applicant, the approval is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to further postpone the expiry date of the approval for a period of time sufficient to enable the examination of the application. Taking into account the time-limits for evaluation by the evaluating competent authority, for preparation and submission by the Agency of its opinion and the time needed for the Commission to decide whether to renew the approval of Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 for use in biocidal products of product-type 18, the expiry date should be postponed to 31 March 2028.












(9)


After the further postponement of the expiry date of the approval, Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 remains approved for use in biocidal products of product-type 18 subject to the conditions set out in Annex I to Directive 98/8/EC,





HAS ADOPTED THIS DECISION:



Article 1
The expiry date of the approval of Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 for use in biocidal products of product-type 18 set out in Annex I to Directive 98/8/EC is postponed to 31 March 2028.


Article 2
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




Done at Brussels, 14 November 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2)  Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1, ELI: http://data.europa.eu/eli/dir/1998/8/oj).

(3)  Commission Implementing Decision (EU) 2023/1085 of 2 June 2023 postponing the expiry date of the approval of Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 for use in biocidal products of product-type 18 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 144, 5.6.2023, p. 94; ELI: http://data.europa.eu/eli/dec_impl/2023/1085/oj).


ELI: http://data.europa.eu/eli/dec_impl/2025/2299/oj
ISSN 1977-0677 (electronic edition)