Renewal of the approval of the active substance Bacillus thuringiensis subsp. Kurstaki EG2348

(1)

Commission Directive 2008/113/EC (2) included a reference to the approval of Bacillus thuringiensis subsp. kurstaki EG2348 as an active substance in Annex I to Council Directive 91/414/EEC (3).

(2)

According to Article 78(3) of Regulation (EC) No_1107/2009, active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

(3)

The approval of the active substance Bacillus thuringiensis subsp. kurstaki EG2348, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011 expires on 15 August 2024.

(4)

On 28 April 2016 an application for the renewal of the approval of the active substance Bacillus thuringiensis subsp. kurstaki EG2348 was submitted to Denmark, the rapporteur Member State, and the Netherlands, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) and within the time period provided for in that Article.

(5)

The applicant also submitted the supplementary dossiers required by Article 6 of Implementing Regulation (EU) No 844/2012 to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’). The application was found to be admissible by the rapporteur Member State.

(6)

The rapporteur Member State prepared a draft renewal assessment report, in consultation with the co-rapporteur Member State, and submitted it to the Authority and the Commission on 28 June 2019. In its draft renewal assessment report, the rapporteur Member State proposes to renew the approval of Bacillus thuringiensis subsp. kurstaki EG2348.

(7)

The Authority communicated the draft renewal assessment report to the applicant and to the Member States for comments, launched a public consultation, and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

(8)

On 2 March 2021, the Authority communicated to the Commission its conclusion (6), which indicates that Bacillus thuringiensis subsp. kurstaki EG2348 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(9)

The Commission presented a renewal report regarding Bacillus thuringiensis subsp. kurstaki EG2348 and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 5 July 2021 and on 25 January 2023, respectively.

(10)

The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined and taken into consideration.

(11)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance Bacillus thuringiensis subsp. kurstaki EG2348 that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(12)

It is therefore appropriate to renew the approval of Bacillus thuringiensis subsp. kurstaki EG2348.

(13)

It is, however, necessary to provide for certain conditions pursuant to Article 14(1), read in conjuction with Article 6, of Regulation (EC) No 1107/2009. It is, in particular, appropriate as a precautionary approach for consumer dietary protection to include a minimum time period between the application of plant protection products containing Bacillus thuringiensis subsp kurstaki EG2348 and the harvest of edible crops used for fresh consumption, unless residues data show levels of Bacillus thuringiensis subsp. kurstaki EG2348 below 105 CFU/g at harvest.

(14)

In addition, in order to increase the confidence in the conclusion that Bacillus thuringiensis subsp kurstaki EG2348 does not affect human health, the applicant should provide further data regarding the density decline of viable spores of Bacillus thuringiensis subsp. kurstaki EG2348 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 105 CFU/g.

(15)

Furthermore, it is appropriate to require that Member States, when assessing applications for authorisations of plant protection products containing Bacillus thuringiensis subsp. kurstaki EG2348, pay particular attention to the protection of operators and workers.

(16)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(17)

Commission Implementing Regulation (EU) 2023/689 (7) extended the approval of Bacillus thuringiensis subsp. kurstaki EG2348 until 15 August 2024 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date.

(18)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,