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’