
Article 1 
The approval of the active substance Verticillium albo-atrum strain WCS850 is renewed as set out in Annex I.
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.
It shall apply from 1 November 2019.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 4 October 2019.
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
Verticillium albo-atrum strain WCS850 (culture collection No CBS 276.92) Not applicable Minimum concentration:0,7 × 107 CFU/ml distilled waterMaximum concentration:1,5 × 107 CFU/ml distilled waterNo relevant impurities. 1 November 2019 31 October 2034 For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Verticillium albo-atrum strain WCS850, and in particular Appendices I and II thereto, 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 Verticillium albo-atrum strain WCS850 is to be considered as a potential sensitiser.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in OECD Issue Paper on Microbial Contaminant Limits for Microbial Pest Control Products, contained in the Commission Working Document SANCO/12116/2012


ANNEX II

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

((1)) in Part A, entry 209 on Verticillium albo-atrum is deleted;
((2)) in Part D, the following entry is added:

No. Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
‘18 Verticillium albo-atrum strain WCS850 (culture collection No CBS 276.92) Not applicable Minimum concentration:0,7 × 107 CFU/ml distilled waterMaximum concentration:1,5 × 107 CFU/ml distilled waterNo relevant impurity 1 November 2019 31 October 2034 For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Verticillium albo-atrum strain WCS850, and in particular Appendices I and II thereto, 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 Verticillium albo-atrum strain WCS850 is to be considered as a potential sensitiser.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in OECD Issue Paper on Microbial Contaminant Limits for Microbial Pest Control Products, contained in the Commission Working Document SANCO/12116/2012.’


