(fra kommisjonsbeslutningen)

(1)    Bacillus thuringiensis subsp. kurstaki, serotype 3a3b, strain ABTS-351 was approved as an active substance for use in biocidal products of product-type 18 by Commission Implementing Regulation (EU) 2016/1929  subject to the conditions set out in the Annex to that Regulation.

(2)    The approval of Bacillus thuringiensis subsp. kurstaki, serotype 3a3b, strain ABTS-351 for use in biocidal products of product-type 18 (‘the approval’) is to expire on 28 February 2027. On 26 August 2025, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of that approval.

(3)    On 5 November 2025, the evaluating competent authority of France 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)    It is possible for the evaluating competent authority to 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)    On 2 July 2026, the evaluating competent authority informed the Commission that the evaluation is delayed due to the need by the authority to assess new studies linked to Analytical Methods, Physico-Chemical Properties, and Physical Hazards of the substance, as well as new uses, leading to the need to perform additional risk assessments. From the information provided by the evaluating competent authority it appears that, for reasons beyond the control of the applicant, it is unlikely that that authority will submit a renewal assessment report to the Agency before the end of 2028.

(7)    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 postpone the expiry date of the approval for a period of time sufficient to enable the examination of the application. 

(8)    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. kurstaki, serotype 3a3b, strain ABTS-351 for use in biocidal products of product-type 18, the expiry date of that approval should be postponed to 31 August 2029.

(9)    After the postponement of the expiry date of the approval, Bacillus thuringiensis subsp. kurstaki, serotype 3a3b, strain ABTS-351 remains approved for use in biocidal products of product-type 18 subject to the conditions set out in the Annex to Implementing Regulation (EU) 2016/1929,