Commission Implementing Regulation (EU) 2018/1915 of 6 December 2018 approving the active substance Metschnikowia fructicola strain NRRL Y-27328 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance.)

Approval of active substance

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.

Amendments to Implementing Regulation (EU) No 540/2011

Article 2

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Entry into force

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 .

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Metschnikowia fructicola strain NRRL Y-27328 Accession 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 × 10 10 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. ( 1 )   Further details on identity and specification of active substance are provided in the review report.

ANNEX IISupplementary provisions

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  ( 1 ) Date of approval Expiration of approval Specific provisions ‘129 Metschnikowia fructicola strain NRRL Y-27328 Accession 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 × 10 10 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.’ ( 1 )   Further details on identity and specification of active substance are provided in the review report.