ANNEX IISupplementary provisions
ANNEX II The Annex to Commission Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, entry 138 on Bacillus subtilis (Cohn 1872) strain QST 713 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 ‘158 Bacillus amyloliquefaciens strain QST 713 n.a. The nominal content of Bacillus amyloliquefaciens strain QST 713 in the technical product and formulation is Minimum: 1 × 10 12 CFU/kg Maximum: 3 × 10 13 CFU/kg No relevant impurities 1 July 2023 30 June 2038 When authorising plant protection products containing Bacillus amyloliquefaciens strain QST 713 for spray applications outdoors, in order to ensure the protection of non-target organisms, including bees, Member States shall: — only authorise field applications in flowering crops or in presence of flowering weed in the field outside the daily foraging period of bees; — implement risk mitigation measures which aim to reduce drift to off-field areas (e.g. considering the application of buffer zones and drift reduction nozzles). 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 Bacillus amyloliquefaciens strain QST 713, and in particular Appendices I and II thereof, shall be taken into account. In addition, Member States shall pay particular attention to: — the assurance by the producer of 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 ( 2 ) — the specification of the technical material as commercially manufactured used in plant protection products; — the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use.’ ( 1 ) Further details on the identity and the specification of the active substance are provided in the renewal report. ( 2 ) pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (europa.eu).