ANNEX IISupplementary provisions
ANNEX II In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added: Number Common Name, Identification Numbers IUPAC Name Purity ( *1 ) Date of approval Expiration of approval Specific provisions ‘75 Bacillus pumilus QST 2808 USDA Agricultural Research Service (NRRL) Patent culture collection in Peoria Illinois, USA under the reference number B-30087 Not applicable ≥ 1 × 10 12 CFU/kg 1 September 2014 31 August 2024 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 Bacillus pumilus QST 2808, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Bacillus pumilus QST 2808 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (a) the identification of the aminosugar produced by Bacillus pumilus QST 2808; (b) analytical data for the content of that aminosugar in the production batches. The applicant shall submit that information to the Commission, the Member States and the Authority by 31 August 2016.’ ( *1 ) Further details on identity and specification of active substance are provided in the review report.