Commission Implementing Regulation (EU) 2019/1675 of 4 October 2019 renewing the approval of the active substance Verticillium albo-atrum strain WCS850 as a low-risk substance 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)

Renewal of the approval of the active substance

Article 1

The approval of the active substance Verticillium albo-atrum strain WCS850 is renewed as set out in Annex I.

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 and date of application

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.

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) 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 × 10 7 CFU/ml distilled water Maximum concentration: 1,5 × 10 7 CFU/ml distilled water No 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  ( 2 ) ( 1 )   Further details on the identity and the specification of the active substance are provided in the renewal report (EU Pesticide database. ( 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 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  ( 1 ) 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 × 10 7 CFU/ml distilled water Maximum concentration: 1,5 × 10 7 CFU/ml distilled water No 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  ( 2 ) .’ ( 1 )   Further details on the identity and the specification of the active substance are provided in the renewal report. ( 2 )   https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf