Commission Implementing Regulation (EU) 2022/496 of 28 March 2022 approving the low-risk active substance Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV), isolate BV-0004 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 Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

Approval of the active substance

Article 1

The active substance Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV), isolate BV-0004 is approved subject to the conditions set out in Annex I to this Regulation.

Amendments to Implementing Regulation (EU) No 540/2011

Article 2

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

Entry into force

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV), isolate BV-0004 Not applicable The content of the virus in the technical grade active ingredient, produced as an isolated technical material, must be at least 2,0 × 10 11 occlusion bodies/g. 18.4.2022 18.4.2037 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 Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV), isolate BV-0004, 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 strict maintenance of environmental conditions and quality control analysis during the manufacturing process to be assured by the producer, 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 operators and workers, taking into account that microorganisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use. 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 )   https://ec.europa.eu/food/system/files/2016-10/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf

ANNEX IISupplementary provisions

ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (a) in Part A, entry 159 on Spodoptera exigua nuclear polyhedrosis virus is deleted; (b) in Part D, the following entry is added: No Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions ‘37 Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV), isolate BV-0004 Not applicable The content of the virus in the technical grade active ingredient, produced as an isolated technical material, must be at least 2,0 × 10 11 occlusion bodies/g. 18.4.2022 18.4.2037 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 Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV), isolate BV-0004, 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 strict maintenance of environmental conditions and quality control analysis during the manufacturing process to be assured by the producer, 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 operators and workers, taking into account that microorganisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use. 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 )   https://ec.europa.eu/food/system/files/2016-10/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf’