Commission Implementing Regulation (EU) 2023/999 of 23 May 2023 renewing the approval of the active substance Bacillus thuringiensis subsp. israelensis strain AM65-52 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)

• CELEX: Implementing Regulation (EU) 2023/999
• Articles: 5

Article 1 Renewal of the approval of the active substance

The approval of the active substance Bacillus thuringiensis subsp. israelensis strain AM65-52, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.

Article 2 Amendments to Implementing Regulation (EU) No 540/2011

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

Article 3 Entry into force and application

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.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Bacillus thuringiensis subsp. israelensis strain AM65-52

Culture collection No ATCC 1276

Not applicable

No relevant impurities

1 July 2023

30 June 2038

The implementation of the uniform principles, provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the renewal report on Bacillus thuringiensis subsp. israelensis strain AM65-52, and in particular Appendices I and II thereof, 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 microorganisms are per se considered as potential sensitizers;

—

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 ) ;

—

the protection of wild pollinators and of aquatic organisms (e.g. aquatic invertebrates from Diptera taxon in particular) in case of uses in open field. Conditions of use shall include specific risk mitigation measures, where appropriate.

Conditions of use shall include risk mitigation measures, such as:

—

adequate personal protective equipment for operators using products containing Bacillus thuringiensis subsp. israelensis strain AM65-52;

—

In case of authorisation of uses on edible crops, a minimum time period of 3 days shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp. israelensis AM65-52 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. israelensis AM65-52 below 10 5 CFU/g at harvest.

( 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 II

ANNEX II

The Annex to Commission Implementing Regulation (EU) No 540/2011 is amended as follows:

(1)

in Part A, entry 194 on Bacillus thuringiensis subsp . israelensis strain AM65-52 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

‘161

Bacillus thuringiensis subsp. israelensis strain AM65-52

Culture collection No ATCC 1276

Not applicable

No relevant impurities

1 July 2023

30 June 2038

The implementation of the uniform principles, provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the renewal report on Bacillus thuringiensis subsp. israelensis strain AM65-52, and in particular Appendices I and II thereof, 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 microorganisms are per se considered as potential sensitizers;

—

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 ) .

—

the protection of wild pollinators and of aquatic organisms (e.g. aquatic invertebrates from Diptera taxon in particular) in case of uses in open field. Conditions of use shall include specific risk mitigation measures, where appropriate.

Conditions of use shall include risk mitigation measures, such as:

—

adequate personal protective equipment for operators using products containing Bacillus thuringiensis subsp. israelensis strain AM65-52;

—

In case of authorisation of uses on edible crops, a minimum time period of 3 days shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp. israelensis AM65-52 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. israelensis AM65-52 below 10 5 CFU/g at harvest.’

( 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)