
Article 1 
The active substance Metschnikowia fructicola strain NRRL Y-27328, 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, 6 December 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
Metschnikowia fructicola strain NRRL Y-27328Accession number in the Agriculture Research Service Culture Collection at the National center for agricultural utilisation research in Peoria, Illinois USA Not applicable Minimum concentration:1 × 1010 CFU/g 27 December 2018 27 December 2028 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 Metschnikowia fructicola strain NRRL Y-27328, 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 Metschnikowia fructicola strain NRRL Y-27328 is to be considered as a potential sensitizer.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be ensured by the producer.Conditions of use shall include risk mitigation measures, where appropriate.

ANNEX II

In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

No Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
‘129 Metschnikowia fructicola strain NRRL Y-27328Accession number in the Agriculture Research Service Culture Collection at the National center for agricultural utilisation research in Peoria, Illinois USA Not applicable Minimum concentration:1 × 1010 CFU/g 27 December 2018 27 December 2028 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 Metschnikowia fructicola strain NRRL Y-27328, 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 Metschnikowia fructicola strain NRRL Y-27328 is to be considered as a potential sensitizer.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be ensured by the producer.Conditions of use shall include risk mitigation measures, where appropriate.’

