# L_2023136EN.01001101.xml

| 24.5.2023 | EN | Official Journal of the European Union | L 136/11 |
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24.5.2023

EN

Official Journal of the European Union

L 136/11

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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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009, of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) thereof,

Whereas:

| (1) | Commission Directive 2008/113/EC (2) included a reference to the approval of Bacillus thuringiensis subsp. israelensis strain AM65-52 as an active substance in Annex I to Council Directive 91/414/EEC (3). |
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(1)

Commission Directive 2008/113/EC (2) included a reference to the approval of Bacillus thuringiensis subsp. israelensis strain AM65-52 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). |
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(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. israelensis strain AM65-52, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 August 2024. |
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(3)

The approval of the active substance Bacillus thuringiensis subsp. israelensis strain AM65-52, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 August 2024.

| (4) | On 27 April 2016 an application for the renewal of the approval of the active substance Bacillus thuringiensis subsp. israelensis strain AM65-52 was submitted to Sweden, the rapporteur Member State and to Spain, the co-rapporteur Member State in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article. |
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(4)

On 27 April 2016 an application for the renewal of the approval of the active substance Bacillus thuringiensis subsp. israelensis strain AM65-52 was submitted to Sweden, the rapporteur Member State and to Spain, the co-rapporteur Member State in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) 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. |
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(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 27 July 2018. In its draft renewal assessment report the rapporteur Member State proposes to renew the approval of Bacillus thuringiensis subsp. israelensis strain AM65-52. |
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(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 27 July 2018. In its draft renewal assessment report the rapporteur Member State proposes to renew the approval of Bacillus thuringiensis subsp. israelensis strain AM65-52.

| (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. |
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(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 12 November 2020, the Authority communicated to the Commission its conclusion (6) which indicates that Bacillus thuringiensis subsp. israelensis strain AM65-52 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. |
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(8)

On 12 November 2020, the Authority communicated to the Commission its conclusion (6) which indicates that Bacillus thuringiensis subsp. israelensis strain AM65-52 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. israelensis strain AM65-52 and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 19 May 2021 and on 25 January 2023, respectively. |
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(9)

The Commission presented a renewal report regarding Bacillus thuringiensis subsp. israelensis strain AM65-52 and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 19 May 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 (7), on the renewal report. The applicant submitted its comments, which have been carefully examined. |
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(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 (7), on the renewal report. The applicant submitted its comments, which have been carefully examined.

| (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. israelensis strain AM65-52 that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. |
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(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. israelensis strain AM65-52 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. israelensis strain AM65-52. |
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(12)

It is therefore appropriate to renew the approval of Bacillus thuringiensis subsp. israelensis strain AM65-52.

| (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 in case of applications for authorisation of uses for edible crops. It is then, in particular, appropriate as a precautionary approach for consumer dietary protection to require that Member States, when assessing applications for authorisations of products containing Bacillus thuringiensis subsp. israelensis strain AM65-52 for uses in edible crop, to set a minimum time period between the application of these products and the harvest of edible crops used for fresh consumption. |
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(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 in case of applications for authorisation of uses for edible crops. It is then, in particular, appropriate as a precautionary approach for consumer dietary protection to require that Member States, when assessing applications for authorisations of products containing Bacillus thuringiensis subsp. israelensis strain AM65-52 for uses in edible crop, to set a minimum time period between the application of these products and the harvest of edible crops used for fresh consumption.

| (14) | Furthermore, it is appropriate to require that Member States, when assessing applications for authorisations of plant protection products containing Bacillus thuringiensis subsp. israelensis strain AM65-52, pay particular attention to the protection of operators and workers. |
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(14)

Furthermore, it is appropriate to require that Member States, when assessing applications for authorisations of plant protection products containing Bacillus thuringiensis subsp. israelensis strain AM65-52, pay particular attention to the protection of operators and workers.

| (15) | Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
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(15)

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

| (16) | Commission Implementing Regulation (EU) 2023/689 (8) extended the approval period of Bacillus thuringiensis subsp. israelensis strain AM65-52 to 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. |
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(16)

Commission Implementing Regulation (EU) 2023/689 (8) extended the approval period of Bacillus thuringiensis subsp. israelensis strain AM65-52 to 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.

| (17) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(17)

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

HAS ADOPTED THIS REGULATION:

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.

Bacillus thuringiensis

israelensis

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.

Official Journal of the European Union

It shall apply from 1 July 2023.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 23 May 2023.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 309, 24.11.2009, p. 1.

1

(2)  Commission Directive 2008/113/EC of 8 December 2008 amending Council Directive 91/414/EEC to include several micro-organisms as active substances (OJ L 330, 9.12.2008, p. 6).

2

(3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

3

(4)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

4

(5)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

5

(6)  EFSA (European Food Safety Authority). Conclusion on the peer review of the pesticide risk assessment of the active substance B. thuringiensis subsp. israelensis strain AM65-52. EFSA Journal, 2020, DOI: 10.2903/j.efsa.2020.6317.

6

B. thuringiensis

israelensis

EFSA Journal

(7)  This Regulation was replaced by Regulation (EU) 2020/1740, however, it continues to apply to the procedure for the renewal of the approval of active substances: (1) whose approval period ends before 27 March 2024; (2) for which a Regulation, adopted in accordance with Article 17 of Regulation (EC) No 1107/2009 on or after 27 March 2021, extends the approval period to 27 March 2024 or a later date.

7

(8)  Commission Implementing Regulation (EU) 2023/689 of 20 March 2023 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, malathion, mepanipyrim, metconazole, metrafenone, pirimicarb, pyridaben, pyrimethanil, rimsulfuron, spinosad, Trichoderma asperellum (formerly T. harzianum) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly T. harzianum) strain T11, Trichoderma gamsii (formerly T. viride) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram (OJ L 91, 29.3.2023, p. 1).

8

Bacillus subtilis

Bacillus thuringiensis

aizawai

Bacillus thuringiensis

israeliensis

Bacillus thuringiensis

kurstaki

Beauveria bassiana

Cydia pomonella Granulovirus

Trichoderma asperellum

T. harzianum

Trichoderma atroviride

T. harzianum

Trichoderma gamsii

T. viride

Trichoderma harzianum

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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; |

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 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. |
| --- | --- |

—

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; |
| --- | --- |

—

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 105 CFU/g at harvest. |
| --- | --- |

—

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 105 CFU/g at harvest.

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(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).

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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; |
| --- | --- |

(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; |

(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 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. |
| --- | --- |

—

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; |
| --- | --- |

—

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 105 CFU/g at harvest.’ |
| --- | --- |

—

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 105 CFU/g at harvest.’

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(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)

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