ANNEX IISupplementary provisions
ANNEX II In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added: ‘130 Beauveria bassiana strain IMI389521 Accession number in the CABI Genetic Resource Collection: IMI389521 Not applicable Max. level of beauvericin: 0,09 mg/kg 19 February 2019 19 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 IMI389521, 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 storage stability of the formulation(s) containing B. bassiana strain IMI389521 including the level of the metabolite beauvericin content after storage; — the content of the metabolite beauvericin produced under the application conditions; — the risk posed by beauvericin in infected insects present in the stored grain. Measures are required to ensure that such products do not enter the food and feed chain, taking into account the natural background level of beauvericin on cereal grains; — the protection of operators and workers, taking into account that B. bassiana strain IMI389521 is to be considered, as any micro-organism, as a potential sensitiser. 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. ( *1 ) https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf’