Date: 2023-02-02Category: Not ApplicableState: Union GovernmentCountry: Europe
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)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Implementing Regulation (EU) 2023/216 approves the low-risk active substance Trichoderma atroviride AGR2 for plant protection products, according to Regulation (EC) No 1107/2009. It amends Commission Implementing Regulation (EU) No 540/2011 accordingly. The regulation entered into force on February 22, 2023.
Key Points / Main Content:
* **Approval of Trichoderma atroviride AGR2:**
* The active substance Trichoderma atroviride AGR2 is approved as specified in Annex I, subject to the conditions laid down therein.
* Approval is valid from February 22, 2023, to February 21, 2038.
* Purity details and other specifications are in Annex I and the review report.
* **Amendment to Implementing Regulation (EU) No 540/2011:**
* The Annex to Implementing Regulation (EU) No 540/2011 is amended according to Annex II of this regulation, adding Trichoderma atroviride AGR2 to the list of approved active substances.
* Specific provisions in Annex II must be considered for uniform principles implementation, referencing the review report's conclusions and appendices.
* **Specific Provisions for Implementation:**
* Member States must consider the review report on Trichoderma atroviride AGR2, particularly Appendices I and II, for implementing uniform principles per Article 29(6) of Regulation (EC) No 1107/2009.
* Overall assessment should focus on the technical material specification, including secondary metabolites, and the protection of operators and workers, recommending PPE use to reduce exposure.
Impact Analysis:
**Member States:**
* Impact: Must implement the regulation, paying particular attention to the specifications and conditions outlined in the annexes and review report when assessing plant protection products containing Trichoderma atroviride AGR2.
* Action Required: Incorporate the provisions of this regulation into their national frameworks and ensure compliance with the specified conditions for using Trichoderma atroviride AGR2.
**Plant Protection Product Manufacturers/Applicants:**
* Impact: Can now market plant protection products containing Trichoderma atroviride AGR2, subject to the conditions and specifications outlined in the regulation.
* Action Required: Ensure that their products meet the purity and formulation requirements specified in Annex I and comply with the conditions for use, including worker protection measures.
**Operators and Workers:**
* Impact: Subject to safety measures regarding potential sensitization from microorganisms.
* Action Required: Use recommended Personal Protective Equipment (PPE) to reduce dermal and inhalation exposure.
Key Entities Referenced
Trichoderma atroviride AGR2: A low-risk active substance used in plant protection products.
Regulation EC No 1107/2009: Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market.
Commission Implementing Regulation EU No 540/2011: Commission Implementing Regulation as regards the list of approved active substances.
European Food Safety Authority: The Authority that was notified of the admissibility of the application and received the draft assessment report.
France: The Member State that received the application for approval of Trichoderma atroviride AGR2 and acted as rapporteur.
Agrolor: The applicant for the approval of the active substance Trichoderma atroviride AGR2.
European Parliament: Legislative branch of the European Union
Brussels: Location where the regulation was adopted.
2.2.2023 EN Official Journal of the European Union L 30/7
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)
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(1), 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 2018of
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(2) 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.
(1) OJ L 309, 24.11.2009, p. 1.
(2) EFSA (European Food Safety Authority), 2022. Conclusion on the peer review of the pesticide risk assessment of the active substance
Trichoderma atroviride strain AGR2: EFSA Journal 2022;20(3):7199 DOI: 10.2903/j.efsa.2022.7199. Available online: www.efsa.
europa.eu.L 30/8 EN Official Journal of the European Union 2.2.2023
(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(3)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
(3) Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the
European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).ANNEX I
Common Name,
IUPAC Name Purity(1) Date of approval Expiration of approval Specific provisions
Identification Numbers
Trichoderma atroviride n.a. The nominal content of Trichoderma 22 February 2023 21 February 2038 For the implementation of the uniform principles, as referred
AGR2 atroviride AGR2 in the technical to in Article 29(6) of Regulation (EC) No 1107/2009, the
product and formulation is Minimal: conclusions of the review report on Trichoderma atroviride
5 x 1011 CFU/kg AGR2 and in particular Appendices I and II thereof, shall be
Nominal: 1 x 1012 CFU/kg taken into account.
Maximal: 1 x 1013 CFU/kg No In this overall assessment, Member States shall pay particular
relevant impurities 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 recom
mended 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.
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30/9ANNEX II
In Part D of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Common Name,
No. IUPAC Name Purity(1) Date of approval Expiration of approval Specific provisions
Identification Numbers
‘42 Trichoderma atroviride n.a. The nominal content of 22 February 2023 21 February 2038 For the implementation of the uniform principles, as
AGR2 Trichoderma atroviride AGR2 in referred to in Article 29(6) of Regulation (EC)
the technical product and No 1107/2009, the conclusions of the review report
formulation is Minimal: 5 x on Trichoderma atroviride AGR2 and in particular
1011 CFU/kg Appendices I and II thereof, shall be taken into
Nominal: 1 x 1012 CFU/kg account.
Maximal: 1 x 1013 CFU/kg No In this overall assessment Member States shall pay
relevant impurities particular attention to:
— the specification of the technical material as com
mercially manufactured used in plant protection
products, including full characterisation of rele
vant secondary metabolites;
— the protection of operators and workers, taking
into account that microorganisms are per se con
sidered 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.
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