Commission Implementing Regulation (EU) 2022/501 of 25 March 2022 approving the active substance Beauveria bassiana strain 203 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) 2022/501
• Articles: 5

Article 1 Approval of the active substance

The active substance Beauveria bassiana strain 203, as specified in Annex I, is approved 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

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

Beauveria bassiana strain 203

Accession number at Centraal Bureau voor Schimmelcultures (Fungal Biodiversity Centre, Institute of the Royal Netherlands Academy of Arts and Sciences, Utrecht, Netherlands): CBS 121097

Not applicable

Max. level of beauvericin: 80 μg/kg in the formulated product.

19 April 2022

18 April 2032

Only uses on ornamental palm trees shall be authorised.

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 Beauveria bassiana strain 203, 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 maximum level of the metabolite beauvericin in the plant protection product;

b)

the protection of operators and workers, taking into account that the species Beauveria basssiana , irrespective of the strain, is a potential human allergen by both skin and inhalatory exposure, and therefore ensuring that adequate personal protective equipment is included as a condition of use.

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 the Working Document SANCO/12116/2012  ( 2 ) .

Conditions of use shall include risk mitigation measures, where appropriate.

( 1 )   Further details on identity and specification of the 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 B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

‘151

Beauveria bassiana strain 203

Accession number at Centraal Bureau voor Schimmelcultures (Fungal Biodiversity Centre, Institute of the Royal Netherlands Academy of Arts and Sciences, Utrecht, Netherlands): CBS 121097

Not applicable

Max. level of beauvericin: 80 μg/kg in the formulated product.

19 April 2022

18 April 2032

Only uses on ornamental palm trees shall be authorised.

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 Beauveria bassiana strain 203, 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 maximum level of the metabolite beauvericin in the plant protection product;

b)

the protection of operators and workers, taking into account that the species Beauveria basssiana , irrespective of the strain, is a potential human allergen by both skin and inhalatory exposure, and therefore ensuring that adequate personal protective equipment is included as a condition of use.

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 the Working Document SANCO/12116/2012  ( *1 ) .

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.’