ANNEX IISupplementary provisions
ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, entry 202 on Pythium oligandrum strain M1 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 ‘ 155 Pythium oligandrum strain M1 Culture collection No ATCC 38472 Not applicable No relevant impurities 1 March 2023 28 February 2038 For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Pythium oligandrum strain M1, 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 specification of the technical material as commercially manufactured, — the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitisers and that physical effects on the respiratory system due to the remnants of culture medium and co-formulants in the Microbial Pest Control Product (MPCP) cannot be excluded. Conditions of use shall include risk mitigation measures, such as: — adequate personal protective and respiratory protective equipment for operators using products containing Pythium oligandrum strain M1. ( 1 ) Further details on the identity and the specification of the active substance are provided in the renewal report.’