Commission Implementing Regulation (EU) 2022/2314 of 25 November 2022 renewing the approval of the active substance Pythium oligandrum strain M1 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) 2022/2314
• Articles: 5

Article 1 Renewal of the approval of the active substance

The approval of the active substance Pythium oligandrum strain M1, as specified in Annex I to this Regulation, 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 2023.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Pythium oligandrum strain M1

Culture collection No ATCC 38472

Not applicable

No relevant impurities

1 March 2023

28 February 2038

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 Pythium oligandrum strain M1, and in particular Appendices I and II thereof, shall be taken into account.

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

—

the specification of the technical material as commercially manufactured,

—

the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitisers and that physical effects on the respiratory system due to the remnants of culture medium and co-formulants in the Microbial Pest Control Product (MPCP) cannot be excluded.

Conditions of use shall include risk mitigation measures, such as:

—

adequate personal protective and respiratory protective equipment for operators using products containing Pythium oligandrum strain M1.

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

ANNEX II

ANNEX II

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

(1)

in Part A, entry 202 on Pythium oligandrum strain M1 is deleted;

(2)

in Part B, the following entry is added:

No

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

‘ 155

Pythium oligandrum strain M1

Culture collection No ATCC 38472

Not applicable

No relevant impurities

1 March 2023

28 February 2038

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 Pythium oligandrum strain M1, and in particular Appendices I and II thereof, shall be taken into account.

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

—

the specification of the technical material as commercially manufactured,

—

the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitisers and that physical effects on the respiratory system due to the remnants of culture medium and co-formulants in the Microbial Pest Control Product (MPCP) cannot be excluded.

Conditions of use shall include risk mitigation measures, such as:

—

adequate personal protective and respiratory protective equipment for operators using products containing Pythium oligandrum strain M1.

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