Commission Implementing Regulation (EU) 2019/147 of 30 January 2019 approving the active substance Beauveria bassiana strain PPRI 5339, 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 Beauveria bassiana strain PPRI 5339, 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 Beauveria bassiana strain PPRI 5339 Accession number in the Agricultural Research Culture Collection (NRRL) International Depositary Authority: NRRL 50757 Not applicable Max. level of beauvericin: 0,5 mg/kg 20 February 2019 20 February 2029 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 Beauveria bassiana strain PPRI 5339, 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 level of the metabolite beauvericin content in a shelf-life study after storage of the formulation(s) containing B. bassiana strain PPRI 5339; — the effects on pollinators introduced in glasshouses following exposure to formulation(s) different from the representative one supporting this approval; — the protection of operators and workers, taking into account that B. bassiana strain PPRI 5339 is to be considered, as any micro-organism, as a potential sensitizer. The compliance with strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012  ( 2 ) . 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. ( 2 )   https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf

ANNEX IISupplementary provisions

ANNEX II In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added: ‘131 Beauveria bassiana strain PPRI 5339 Accession number in the Agricultural Research Culture Collection (NRRL) International Depositary Authority: NRRL 50757 Not applicable Max. level of beauvericin: 0,5 mg/kg 20 February 2019 20 February 2029 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 Beauveria bassiana strain PPRI 5339, 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 level of the metabolite beauvericin content in a shelf-life study after storage of the formulation(s) containing B. bassiana strain PPRI 5339; — the effects on pollinators introduced in glasshouses following exposure to formulation(s) different from the representative one supporting this approval; — the protection of operators and workers, taking into account that B. bassiana strain PPRI 5339 is to be considered, as any micro-organism, as a potential sensitizer. The compliance with strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012  ( *1 ) . Conditions of use shall include risk mitigation measures where appropriate. ( *1 )   https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf’