# L_2019027EN.01001401.xml

| 31.1.2019 | EN | Official Journal of the European Union | L 27/14 |
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31.1.2019

EN

Official Journal of the European Union

L 27/14

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/147

of 30 January 2019

approving the active substance Beauveria bassiana strain PPRI 5339, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to 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 13(2) thereof,

Whereas:

| (1) | In accordance with Article 7(1) of Regulation (EC) No 1107/2009 the Netherlands received on 1 October 2014 an application from BASF Corporation for the approval of the active substance Beauveria bassiana strain PPRI 5339. |
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(1)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009 the Netherlands received on 1 October 2014 an application from BASF Corporation for the approval of the active substance Beauveria bassiana strain PPRI 5339.

| (2) | In accordance with Article 9(3) of Regulation (EC) No 1107/2009, the Netherlands, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 2 June 2015 of the admissibility of the application. |
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(2)

In accordance with Article 9(3) of Regulation (EC) No 1107/2009, the Netherlands, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 2 June 2015 of the admissibility of the application.

| (3) | On 22 December 2016 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. |
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(3)

On 22 December 2016 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

| (4) | The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report in November 2017. |
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(4)

The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report in November 2017.

| (5) | On 12 March 2018 the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance Beauveria bassiana strain PPRI 5339 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public. |
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(5)

On 12 March 2018 the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance Beauveria bassiana strain PPRI 5339 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.

| (6) | On 24 October 2018 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the draft review report for Beauveria bassiana strain PPRI 5339 and a draft Regulation providing that Beauveria bassiana strain PPRI 5339 is approved. |
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(6)

On 24 October 2018 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the draft review report for Beauveria bassiana strain PPRI 5339 and a draft Regulation providing that Beauveria bassiana strain PPRI 5339 is approved.

| (7) | It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. |
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(7)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

| (8) | It is therefore appropriate to approve Beauveria bassiana strain PPRI 5339. |
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(8)

It is therefore appropriate to approve Beauveria bassiana strain PPRI 5339.

| (9) | In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions. In particular, it is appropriate to include risk mitigation measures where appropriate. |
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(9)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions. In particular, it is appropriate to include risk mitigation measures where appropriate.

| (10) | In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly. |
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(10)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly.

| (11) | 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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(11)

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

Approval of active substance

The active substance Beauveria bassiana strain PPRI 5339, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Beauveria bassiana

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

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

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

Done at Brussels, 30 January 2019.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the pesticide risk assessment of the active substance Beauveria bassiana strain PPRI 5339. EFSA Journal 2018;16(4):5230, 18 pp. doi:10.2903/j.efsa.2018.5230.

2

(3)  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).

3

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Beauveria bassiana strain PPRI 5339
  Accession number in the Agricultural Research Culture Collection (NRRL) International Depositary Authority: NRRL 50757 | Not applicable | Max. level of beauvericin: 0,5 mg/kg | 20 February 2019 | 20 February 2029 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Beauveria bassiana strain PPRI 5339, and in particular Appendices I and II thereof, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  — | the level of the metabolite beauvericin content in a shelf-life study after storage of the formulation(s) containing B. bassiana strain PPRI 5339; |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Beauveria bassiana strain PPRI 5339

Accession number in the Agricultural Research Culture Collection (NRRL) International Depositary Authority: NRRL 50757

Not applicable

Max. level of beauvericin: 0,5 mg/kg

20 February 2019

20 February 2029

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Beauveria bassiana strain PPRI 5339, and in particular Appendices I and II thereof, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

—

the level of the metabolite beauvericin content in a shelf-life study after storage of the formulation(s) containing B. bassiana strain PPRI 5339;

| — | the effects on pollinators introduced in glasshouses following exposure to formulation(s) different from the representative one supporting this approval; |
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—

the effects on pollinators introduced in glasshouses following exposure to formulation(s) different from the representative one supporting this approval;

| — | the protection of operators and workers, taking into account that B. bassiana strain PPRI 5339 is to be considered, as any micro-organism, as a potential sensitizer. |
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—

the protection of operators and workers, taking into account that B. bassiana strain PPRI 5339 is to be considered, as any micro-organism, as a potential sensitizer.

The compliance with 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 risk mitigation measures where appropriate.

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(1)  Further details on identity and specification of active substance are provided in the review report.

(2)  https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf

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ANNEX II

In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

| ‘131 | Beauveria bassiana strain PPRI 5339
  Accession number in the Agricultural Research Culture Collection (NRRL) International Depositary Authority: NRRL 50757 | Not applicable | Max. level of beauvericin: 0,5 mg/kg | 20 February 2019 | 20 February 2029 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Beauveria bassiana strain PPRI 5339, and in particular Appendices I and II thereof, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  — | the level of the metabolite beauvericin content in a shelf-life study after storage of the formulation(s) containing B. bassiana strain PPRI 5339; |
| --- | --- | --- | --- | --- | --- | --- | --- |

‘131

Beauveria bassiana strain PPRI 5339

Accession number in the Agricultural Research Culture Collection (NRRL) International Depositary Authority: NRRL 50757

Not applicable

Max. level of beauvericin: 0,5 mg/kg

20 February 2019

20 February 2029

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Beauveria bassiana strain PPRI 5339, and in particular Appendices I and II thereof, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

—

the level of the metabolite beauvericin content in a shelf-life study after storage of the formulation(s) containing B. bassiana strain PPRI 5339;

| — | the effects on pollinators introduced in glasshouses following exposure to formulation(s) different from the representative one supporting this approval; |
| --- | --- |

—

the effects on pollinators introduced in glasshouses following exposure to formulation(s) different from the representative one supporting this approval;

| — | the protection of operators and workers, taking into account that B. bassiana strain PPRI 5339 is to be considered, as any micro-organism, as a potential sensitizer. |
| --- | --- |

—

the protection of operators and workers, taking into account that B. bassiana strain PPRI 5339 is to be considered, as any micro-organism, as a potential sensitizer.

The compliance with 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 (*1).

Conditions of use shall include risk mitigation measures where appropriate.

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(*1)  https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf’

*1

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