Commission Implementing Regulation (EU) 2025/103 of 22 January 2025 approving the active substance Betabaculovirus phoperculellae as a low-risk active substance 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
Date: 2025-01-22
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: market approval, microorganism, plant health control, plant health product








L_202500103EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/103


23.1.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/103
of 22 January 2025
         
approving the active substance Betabaculovirus phoperculellae as a low-risk active substance 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 13(2) in conjunction with Article 22(1) thereof,

Whereas:







(1)


On 30 November 2018, the Netherlands received an application pursuant to Article 7(1) of Regulation (EC) No 1107/2009 from Andermatt Biocontrol Suisse AG for the approval of the active substance Phthorimaea operculella granulovirus.












(2)


The name Phthorimaea operculella granulovirus was changed to Betabaculovirus phoperculellae in 2023 by the International Committee on Taxonomy of Viruses. The European Food Safety Authority (‘the Authority’) confirmed the scientific correctness of this taxonomic reallocation.












(3)


In accordance with Article 9(3) of that Regulation, on 7 June 2019, the Netherlands, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the Authority of the admissibility of the application.












(4)


On 25 March 2022, 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.












(5)


The Authority circulated the draft assessment report received from the rapporteur Member State to the applicant and the other Member States. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, the Authority 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 form of an updated draft assessment report on 10 November 2023.












(6)


On 22 July 2024, the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance at issue can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The conclusion still referred to the name Phthorimaea operculella granulovirus. The Authority made its conclusion available to the public.












(7)


The Commission presented a review report and a draft Regulation regarding Betabaculovirus phoperculellae to the Standing Committee on Plants, Animals, Food and Feed on 2 October 2024 and on 4 December 2024, respectively.












(8)


The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 13(1) of Regulation (EC) No 1107/2009, on the review report. The applicant submitted its comments, which have been carefully examined.












(9)


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.












(10)


The Commission further considers that Betabaculovirus phoperculellae is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Betabaculovirus phoperculellae is not a substance of concern and fulfils the conditions set in point 5.2.2 of Annex II to Regulation (EC) No 1107/2009, in the version thereof applicable to the procedure for the approval of that active substance, as it belongs to the Baculoviridae family and has not demonstrated adverse effects on any non-target insects.












(11)


It is therefore appropriate to approve Betabaculovirus phoperculellae as a low-risk active substance.












(12)


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 necessary to include certain conditions in order to ensure the fulfilment of the limits on relevant microbiological contamination and the protection of operators and workers, taking into account that all microorganisms are considered as potential sensitizers.












(13)


In accordance with Article 13(4) of Regulation (EC) No 1107/2009 in conjunction with Article 22(2) thereof, Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly.












(14)


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 the active substance

The active substance Betabaculovirus phoperculellae, as specified in Annex I, is approved, subject to the conditions laid down in that Annex I.


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.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 January 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj.

(2)  Conclusion on the peer review of the pesticide risk assessment of the active substance Phthorimaea operculella granulovirus. EFSA Journal 2024;22:e8976, https://doi.org/10.2903/j.efsa.2024.8976.

(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, ELI: http://data.europa.eu/eli/reg_impl/2011/540/oj).




ANNEX I










Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Expiration of approval


Specific provisions





Betabaculovirus phoperculellae



Not applicable


No relevant impurities


12 February 2025


12 February 2040


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 Betabaculovirus phoperculellae, and in particular Appendices I and II thereto, shall be taken into account.
In this overall assessment Member States shall pay particular attention to:






—


the protection of operators and workers, taking into account that all microorganisms are considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use;










—


the guarantee by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the adherence of the limits on microbiological contamination as set in the OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No 65 (2).




Conditions of use shall include risk mitigation measures, where appropriate.






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

(2)  Organisation for Economic Cooperation and Development (2014), OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products, Series on Pesticides and Biocides, No 65, OECD Publishing, Paris, https://doi.org/10.1787/9789264221642-en.





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












No


Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Expiration of approval


Specific provisions




‘49



Betabaculovirus phoperculellae



Not applicable


No relevant impurities


12 February 2025


12 February 2040


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 Betabaculovirus phoperculellae, and in particular Appendices I and II thereto, shall be taken into account.
In this overall assessment Member States shall pay particular attention to:






—


the protection of operators and workers, taking into account that all microorganisms are considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use;










—


the guarantee by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the adherence of the limits on microbiological contamination as set in the OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No 65 (2).




Conditions of use shall include risk mitigation measures, where appropriate.







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

(2)  Organisation for Economic Cooperation and Development (2014), OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products, Series on Pesticides and Biocides, No 65, OECD Publishing, Paris, https://doi.org/10.1787/9789264221642-en.’
         



ELI: http://data.europa.eu/eli/reg_impl/2025/103/oj
ISSN 1977-0677 (electronic edition)