Commission Implementing Regulation (EU) 2021/853 of 27 May 2021 renewing the approval of the active substance Streptomyces strain K61 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)

• CELEX: Implementing Regulation (EU) 2021/853
• Articles: 5

Article 1 Renewal of the approval of the active substance

The approval of the active substance Streptomyces strain K61, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.

Article 2 Amendments to Implementing Regulation (EU) No 540/2011

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

Article 3 Entry into force and date of application

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 July 2021.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Streptomyces strain K61

Not applicable

No relevant impurities

1 July 2021

30 June 2036

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 Streptomyces s train K61 and in particular Appendices I and II thereto, shall be taken into account.

Member States shall pay particular attention to the protection of operators and workers, taking into account that microorganisms are considered as potential sensitisers, and shall ensure that adequate personal protective equipment is included as a condition of use.

Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination  ( 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

ANNEX II

ANNEX II

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

(1)

in Part A, entry 203 on Streptomyces K61 (formerly S. griseoviridis ) is deleted;

(2)

in Part B, the following entry is added:

‘145

Streptomyces strain K61

Not applicable

No relevant impurities

1 July 2021

30 June 2036

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 Streptomyces s train K61 and in particular Appendices I and II thereto, shall be taken into account.

Member States shall pay particular attention to the protection of operators and workers, taking into account that microorganisms are considered as potential sensitisers, and shall ensure that adequate personal protective equipment is included as a condition of use.

Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination  ( *1 ) .

( *1 )   https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf.’