Commission Implementing Regulation (EU) 2021/134 of 4 February 2021 renewing the approval of the low-risk active substance Akanthomyces muscarius strain Ve6 (formerly Lecanicillium muscarium strain Ve6) 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) 2021/134
• Articles: 5

Article 1 Renewal of the approval of the active substance

The approval of the active substance Akanthomyces muscarius strain Ve6 (formerly Lecanicillium muscarium strain Ve6), 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 March 2021.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Akanthomyces muscarius strain Ve6 (formerly Lecanicillium muscarium strain Ve6)  ( 2 )

Not applicable

No relevant impurities

1 March 2021

29 February 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 Akanthomyces muscarius strain Ve6 (formerly Lecanicillium muscarium strain Ve6) 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 per se 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  ( 3 ) .

( 1 )   Further details on the identity and the specification of the active substance are provided in the renewal report.

( 2 )   The concerned active substance was initially approved as Verticillium lecanii , but later, for scientific reasons, its name was changed to Lecanicillium muscarium strain Ve6, which was later changed again to the name under which the approval was renewed, Akanthomyces muscarius strain Ve6.

( 3 )   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, the entry 199 on Lecanicillium muscarium (formerly Verticilium lecanii ) STRAIN: Ve 6 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

‘25

Akanthomyces muscarius strain Ve6 (formerly Lecanicillium muscarium strain Ve6)  ( 2 )

Not applicable

No relevant impurities

1 March 2021

29 February 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 Akanthomyces muscarius strain Ve6 (formerly Lecanicillium muscarium strain Ve6) 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 per se 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  ( 3 ) .

( 1 )   Further details on the identity and the specification of the active substance are provided in the renewal report.

( 2 )   The concerned active substance was initially approved as Verticillium lecanii , but later, for scientific reasons, its name was changed to Lecanicillium muscarium strain Ve6, which was later changed again to the name under which the approval was renewed, Akanthomyces muscarius strain Ve6.

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