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)
Grade B
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Address https://gelex.eu/eli/EU/regulation/2023/216@2023-02-01/en
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, and in particular Article 13(2) in conjunction with Article 22(1) thereof,
Whereas:
(1) On 24 April 2018, France received an application pursuant to Article 7(1) of Regulation (EC) No 1107/2009 from Agrolor for the approval of the active substance Trichoderma atroviride AGR2.
(2) In accordance with Article 9(3) of that Regulation, France, as rapporteur Member State, notified the applicants, the other Member States, the Commission and the European Food Safety Authority (the Authority) on 5 June 2018 of the admissibility of the application.
(3) On 23 June 2020, after assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009, rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority.
(4) Pursuant to Article 12(1) of Regulation (EC) No 1107/2009, the Authority circulated the draft assessment report to the applicant and to other Member States.
(5) In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested the applicant to supply additional information to the Member States, the Commission and the Authority.
(6) The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the form of an updated draft assessment report.
(7) On 20 January 2022, the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance Trichoderma atroviride AGR2 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.
(8) On 14 July 2022, the Commission presented a review report regarding Trichoderma atroviride AGR2 and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed.
(9) The Commission invited the applicant to submit its comments on the review report. The applicant submitted its comments, which have been carefully examined.
(10) It has been established, with respect to one representative use of at least one plant protection product containing the active substance, which was examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.
(11) The Commission further considers that Trichoderma atroviride AGR2 is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Trichoderma atroviride AGR2 is not a microorganism of concern and fulfils the conditions set in Annex II point 5.2 to Regulation (EC) No 1107/2009.
(12) It is therefore appropriate to approve Trichoderma atroviride AGR2 as a low-risk active substance.
(13) In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to include certain conditions.
(14) In accordance with Article 13(4) of Regulation (EC) No 1107/2009 in conjunction with Article 22(2) thereof, Commission Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(15) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 1 February 2023. For the Commission The President Ursula von der Leyen
ANNEX
ANNEX I
Common Name, Identification Numbers IUPAC Name Purity 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 1011 CFU/kg Nominal: 1 x 1012 CFU/kg Maximal: 1 x 1013 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.
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 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 1011 CFU/kg Nominal: 1 x 1012 CFU/kg Maximal: 1 x 1013 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.
Versions
Cited by
- Commission Regulation (EU) 2024/246 of 16 January 2024 amending Annex IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards Pythium oligandrum strain M1, Trichoderma atroviride strain AGR2 and Trichoderma atroviride strain AT10 (Text with EEA relevance) Regulation · Grade B
Commission Implementing Regulation (EU) 2023/216 approved the low-risk active substance Trichoderma atroviride strain AGR2. During the peer review of the pesticide risk assessment of the active substance under Regulation (EC) No 1107/2009, the Authority concluded that some information was not available as regards the dietary risk assessment for consumers and that further consideration by risk managers was required. As set out in the review report for that active substance in the context of the risk assessment under Regulation (EC) No 1107/2009, Trichoderma atroviride strain AGR2 is not pathoge