ANNEX IISupplementary provisions
ANNEX II In Part D of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added: Common Name, Identification Numbers IUPAC Name Purity ( 1 ) Date of approval Expiration of approval Specific provisions ‘13 Pasteuria nishizawae Pn1 Culture collection: ATCC Safe Deposit (SD-5833) CIPAC No Not allocated Not applicable minimum concentration 1 × 10 11 spores/g 14 October 2018 14 October 2033 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 Pasteuria nishizawae Pn1, 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 protection of operators and workers, taking into account that Pasteuria nishizawae Pn 1 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.’ ( 1 ) Further details on identity and specification of active substance are provided in the review report.