Commission Implementing Regulation (EU) 2023/1005 of 23 May 2023 renewing the approval of the active substance Bacillus thuringiensis subsp. Kurstaki SA-12 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

Renewal of the approval of the active substance

Article 1

The approval of the active substance Bacillus thuringiensis subsp. kurstaki SA-12, as specified in Annex I, is renewed, subject to the conditions laid down in that Annex.

Amendments to Implementing Regulation (EU) No 540/2011

Article 2

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Entry into force and application

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union . It shall apply from 1 July 2023.

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Bacillus thuringiensis subsp . kurstaki SA-12 n.a. No relevant impurities 1 July 2023 30 June 2038 The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp . kurstaki SA-12 and in particular Appendices I and II thereto, are taken into account. In this overall assessment, the Member States shall pay particular attention to: — the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use; — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012  ( 2 ) . Conditions of use shall include the following risk mitigation measures: — A minimum time period of 1 day shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp. kurstaki SA-12 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. kurstaki SA-12 below 10 5 CFU/g at harvest. The applicant shall submit, to the Commission, the Member States and the Authority, additional information as regards: — data in at least one representative edible crop (i.e. on pome fruits and tomatoes) regarding the density decline of viable spores of Bacillus thuringiensis subsp. kurstaki SA-12 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 10 5 CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State by 13 December 2025. ( 1 )   Further details on the identity and the specification of the active substance are provided in the renewal report. ( 2 )   pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (europa.eu).

ANNEX IISupplementary provisions

ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in part A, entry 195 is deleted, (2) in Part B, the following entry is added: No. Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions ‘166 Bacillus thuringiensis subsp . kurstaki SA-12 n.a. No relevant impurities 1 July 2023 30 June 2038 The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp . kurstaki SA-12 and in particular Appendices I and II thereto, are taken into account. In this overall assessment, the Member States shall pay particular attention to: — the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use; — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012  ( 2 ) . Conditions of use shall include the following risk mitigation measures: — A minimum time period of 1 day shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp. kurstaki SA-12 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. kurstaki SA-12 below 10 5 CFU/g as recommended by EFSA. The applicant shall submit, to the Commission, the Member States and the Authority, additional information as regards: — data in at least one representative edible crop (i.e. on pome fruits and tomatoes) regarding the density decline of viable spores of Bacillus thuringiensis subsp. kurstaki SA-12 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 10 5 CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State by 13 December 2025. ( 1 )   Further details on the identity and the specification of the active substance are provided in the renewal report. ( 2 )   pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (europa.eu).’