Contents
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/EECnote, and in particular Article 17, first subparagraph, thereof,Whereas:
(1)According to Article 78(3) of Regulation (EC) No 1107/2009, active substances included in Annex I to Council Directive 91/414/EECnote are deemed to have been approved under Regulation (EC) No 1107/2009. Those substances are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011note.
(2)Such is the case of the active substances dodemorph, fatty acids C8-C10 methyl esters, lauric acid, methyl octanoate, methyl decanoate, oleic acid and Trichoderma atroviride (formerly T. harzianum) strain IMI 206040.
(3)Commission Implementing Regulation (EU) 2023/1446note extended the approval period of the active substance dodemorph until 30 November 2026 and until 15 December 2024 for the group of substances fatty acids C7-C20, which cover fatty acids C8-C10 methyl esters, lauric acid, methyl octanoate, methyl decanoate and oleic acid, pending the remaining steps in the procedure for the renewal of the approval of those substances.
(4)Commission Implementing Regulation (EU) 2023/689note extended the approval period of the active substance Trichoderma atroviride (formerly T. harzianum) until 15 April 2025 for the same reasons.
(5)Among the group of substances fatty acids C7-C20, no application for the renewal of approval of the active substances lauric acid, methyl octanoate, methyl decanoate, oleic acid was submitted, and no supplementary dossier for the renewal of the active substance fatty acids C8-C10 methyl esters was submitted in accordance with Article 5 of Commission Implementing Regulation (EU) 2020/1740note.
(6)No application for the renewal of the strain IMI 206040 of Trichoderma atroviride (formerly T. harzianum) was submitted in accordance with Article 5 of Implementing Regulation (EU) 2020/1740.
(7)For the active substance dodemorph, on 18 December 2023, the applicant confirmed that it no longer supports the application for renewal of the approval.
(8)Therefore, it is no longer justified that the the approval periods of these active substances remain extended. Therefore, a new expiry date should be set at the earliest possible date, while giving Member States sufficient time to withdraw their authorisations for the plant protection products containing those substances.
(9)Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(10)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#
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
Article 2#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
(1)row 204, Trichoderma atroviride (formerly T. harzianum), is replaced by the following:No | Common Name, Identification Numbers | IUPAC Name | Purity | Date of approval | Expiration of approval | Specific provisions204 | Trichoderma atroviride (formerly T. harzianum) | |STRAIN: T11Culture collection: NoSpanish type culture collection CECT 20498, identical with IMI 352941 | Not applicable | No relevant impurities | 1 May 2009 | 15 April 2025 | PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review reports on Trichoderma harzianum T-22 (SANCO/1839/2008) and ITEM 908 (SANCO/1840/208) respectively and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.STRAIN: IMI 206040 – Culture collection No IMI 206040, ATCC 20476 | Not applicable | No relevant impurities | 1 May 2009 | 31 August 2024
(2)row 230, Fatty acids C7 to C20, is replaced by the following:No | Common Name, Identification Numbers | IUPAC Name | Purity | Date of approval | Expiration of approval | Specific provisions230 | Fatty acids C7 to C20 | |CAS No 112-05-0 (Pelargonic Acid)67701-09-1 (Fatty acids C7-C18 and C18 unsaturated potassium salts)124-07-2 (Caprylic Acid)334-48-5 (Capric Acid) | Nonanoic acidCaprylic Acid, Pelargonic Acid, Capric Acid, Lauric Acid, Oleic Acid (ISO in each case)Octanoic Acid, Nonanoic Acid, Decanoic Acid, Dodecanoic Acid, cis-9-Octadecenoic Acid (IUPAC in each case)Fatty acids, C7-C10, Me esters | ≥ 889 g/kg (Pelargonic Acid)≥ 838 g/kg fatty acids≥ 99 % fatty acid methyl esters | 1 September 2009 | 15 December 2024 | PART AOnly uses as insecticide, acaricide, and herbicide and plant growth regulator may be authorised.PART BFor 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 fatty acids (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.143-07-7 (Lauric Acid)112-80-1 (Oleic Acid)85566-26-3 (Fatty acids C8-C10 Me esters)111-11-5 (Methyl octanoate)110-42-9 (Methyl decanoate)CIPAC No not allocated | Nonanoic acidCaprylic Acid, Pelargonic Acid, Capric Acid, Lauric Acid, Oleic Acid (ISO in each case)Octanoic Acid, Nonanoic Acid, Decanoic Acid, Dodecanoic Acid, cis-9-Octadecenoic Acid (IUPAC in each case)Fatty acids, C7-C10, Me esters | ≥ 889 g/kg (Pelargonic Acid)≥ 838 g/kg fatty acids≥ 99 % fatty acid methyl esters | 1 September 2009 | 31 August 2024
(3)in row 264, Dodemorph, in the sixth column, ‘Expiration of approval’, the date is replaced by ‘31 August 2024’.
Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
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