
Article 1 
The active substance Pasteuria nishizawae Pn1, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Article 2 
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 21 September 2018.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX I

Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
Pasteuria nishizawae Pn1Culture collection: ATCC Safe Deposit (SD-5833)CIPAC NoNot allocated Not applicable minimum concentration 1 × 1011 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 ensured by the producer.

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 Date of approval Expiration of approval Specific provisions
‘13 Pasteuria nishizawae Pn1Culture collection: ATCC Safe Deposit (SD-5833)CIPAC NoNot allocated Not applicable minimum concentration 1 × 1011 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.’

