Commission Implementing Regulation (EU) 2023/199 of 30 January 2023 approving the low-risk active substance Trichoderma atroviride AT10 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)

Approval of the active substance

Article 1

The active substance Trichoderma atroviride AT10, is approved subject to the conditions set out in Annex I to this Regulation.

Amendments to Implementing Regulation (EU) No 540/2011

Article 2

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

Entry into force

Article 3

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

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Trichoderma atroviride AT10 n.a. The nominal content of Trichoderma atroviride AT10 in the technical product should be Minimal: 1 x 10 11 CFU/kg Nominal: 5 x 10 11 CFU/kg Maximal: 1 x 10 12 CFU/kg No relevant impurities 20 February 2023 20 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 AT10 and in particular Appendices I and II thereto, 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 considered to reduce dermal and inhalation exposure. ( 1 )   Further details on the identity and the specification of the active substance are provided in the renewal report.

ANNEX IISupplementary provisions

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 ‘43 Trichoderma atroviride AT10 n.a. The nominal content of Trichoderma atroviride AT10 in the technical product and formulation is Minimal: 1 x 10 11 CFU/kg Nominal: 5 x 10 11 CFU/kg Maximal: 1 x 10 12 CFU/kg No relevant impurities 20 February 2023 20 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 AT10 and in particular Appendices I and II thereto, 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 considered to reduce dermal and inhalation exposure. ( 1 )   Further details on the identity and the specification of the active substance are provided in the renewal report.’