Commission Implementing Regulation (EU) 2022/4 of 4 January 2022 approving the active substance Purpureocillium lilacinum strain PL11 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 Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/4
• Articles: 5

Article 1 Approval of the active substance

The active substance Purpureocillium lilacinum strain PL11 is approved as set out in Annex I.

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

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

Article 3 Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX I

ANNEX I

Common Name,

Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Purpureocillium lilacinum strain PL11

Not applicable

No relevant impurities

25 January 2022

24 January 2037

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 Purpureocillium lilacinum strain PL11 and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

a)

the strict maintenance of environmental conditions and quality control analysis during the manufacturing process to be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012  ( 2 ) ;

b)

the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use.

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 II

ANNEX II

In Part D of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

‘34

Purpureocillium lilacinum strain PL11

Not applicable

No relevant impurities

25 January 2022

24 January 2037

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 Purpureocillium lilacinum strain PL11 and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

a)

the strict maintenance of environmental conditions and quality control analysis during the manufacturing process to be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012  ( *1 ) ;

b)

the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use.

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.’