(fra kommisjonsbeslutningen)

(1)    Bacillus sphaericus 2362 serotype H5a5b, strain ABTS1743 was approved as an active substance for use in biocidal products of product-type 18 by Commission Implementing Regulation (EU) 2015/417  subject to the conditions set out in the Annex to that Regulation.

(2)    The approval of Bacillus sphaericus 2362 serotype H5a5b, strain ABTS1743 for use in biocidal products of product-type 18 (‘the approval’) is to expire on 30 June 2026. On 20 December 2024, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of Bacillus sphaericus 2362 serotype H5a5b, strain ABTS1743 for use in biocidal products of product-type 18 (‘the application’).

(3)    On 27 August 2025, 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)    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. 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 sphaericus 2362 serotype H5a5b, strain ABTS1743 for use in biocidal products of product-type 18, the expiry date should be postponed to 31 December 2028.

(7)    After the postponement of the expiry date of the approval, Bacillus sphaericus 2362 serotype H5a5b, strain ABTS1743 remains approved for use in biocidal products of product-type 18 subject to the conditions set out in the Annex to Implementing Regulation (EU) 2015/417,