Commission Implementing Regulation (EU) 2023/216 of 1 February 2023 approving the low-risk active substance Trichoderma atroviride AGR2 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) 2023/216
• Articles: 5

Article 1 Approval of the active substance

The active substance Trichoderma atroviride AGR2, 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

Trichoderma atroviride AGR2

n.a.

The nominal content of Trichoderma atroviride AGR2 in the technical product and formulation is Minimal: 5 x 10 11 CFU/kg

Nominal: 1 x 10 12 CFU/kg

Maximal: 1 x 10 13 CFU/kg No relevant impurities

22 February 2023

21 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 review report on Trichoderma atroviride AGR2 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 used in plant protection products, including full characterisation of relevant secondary metabolites;

—

the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers. Use of PPE/RPE might be recommended to reduce dermal and inhalation exposure.

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

ANNEX II

ANNEX II

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

No.

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

‘42

Trichoderma atroviride AGR2

n.a.

The nominal content of Trichoderma atroviride AGR2 in the technical product and formulation is Minimal: 5 x 10 11 CFU/kg

Nominal: 1 x 10 12 CFU/kg

Maximal: 1 x 10 13 CFU/kg No relevant impurities

22 February 2023

21 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 review report on Trichoderma atroviride AGR2 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 used in plant protection products, including full characterisation of relevant secondary metabolites;

—

the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers. Use of PPE/RPE might be recommended to reduce dermal and inhalation exposure.’

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