Commission Implementing Regulation (EU) 2024/1280 of 30 April 2024 amending Implementing Regulation (EU) No 540/2011 as regards the approval periods 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

Official Journal EN of the European Union L series 2024/1280 3.5.2024 COMMISSION IMPLEMENTING REGULATION (EU) 2024/1280 of 30 April 2024 amending Implementing Regulation (EU) No 540/2011 as regards the approval periods 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 (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 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/EEC(2) 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 540/2011(3).

(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) 2023/1446(4) extended the approval period of the active substance dodemorph until 30 November 2026and until 15 December 2024for 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) 2023/689(5) extended the approval period of the active substance Trichoderma atroviride (formerly T. harzianum) until 15 April 2025for the same reasons.

(1) OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj.

(2) Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230,

19.8.1991, p. 1, ELI: http://data.europa.eu/eli/dir/1991/414/oj).

(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, ELI:

http://data.europa.eu/eli/reg_impl/2011/540/oj).

(4) Commission Implementing Regulation (EU) 2023/1446 of 12 July 2023 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2,5-dichlorobenzoic acid methylester, acetic acid, aluminium ammonium sulphate, aluminium phosphide, aluminium silicate, calcium carbide, cymoxanil, dodemorph, ethylene, extract from tea tree, fat distillation residues, fatty acids C7-C20, flonicamid (IKI-220), gibberellic acid, gibberellins, halosulfuron-methyl, hydrolysed proteins, iron sulphate, magnesium phosphide, maltodextrin, metamitron, plant oils/clove oil, plant oils/rape seed oil, plant oils/spear mint oil, pyrethrins, sulcotrione, tebuconazole and urea (OJ L 178, 13.7.2023, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2023/ 1446/oj).

(5) Commission Implementing Regulation (EU) 2023/689 of 20 March 2023 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, malathion, mepanipyrim, metconazole, metrafenone, pirimicarb, pyridaben, pyrimethanil, rimsulfuron, spinosad, Trichoderma asperellum (formerly T. harzianum) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly T. harzianum) strain T11, Trichoderma gamsii (formerly T. viride) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram (OJ L 91, 29.3.2023, p. 1,

ELI: http://data.europa.eu/eli/reg_impl/2023/689/oj).

ELI: http://data.europa.eu/eli/reg_impl/2024/1280/oj 1/4EN OJ L, 3.5.2024

(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) 2020/1740(6).

(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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 30 April 2024.

For the Commission The President Ursula VON DER LEYEN

(6) Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and repealing Commission Implementing Regulation (EU) No 844/2012 (OJ L 392, 23.11.2020, p. 20,

ELI: http://data.europa.eu/eli/reg_impl/2020/1740/oj).

2/4 ELI: http://data.europa.eu/eli/reg_impl/2024/1280/ojANNEX Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

(1) row 204, Trichoderma atroviride (formerly T. harzianum), is replaced by the following:

Common Name, Expiration of No IUPAC Name Purity(1) Date of approval Specific provisions Identification Numbers approval ‘204 Trichoderma atroviride (formerly T. harzianum)

STRAIN: T11 Not applicable No relevant impurities 1 May 2009 15 April 2025 PART A

Culture collection:

No Only uses as fungicide may be authorised.

Spanish type culture collection CECT PART B 20498, identical with IMI 352941 For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC)

STRAIN: IMI Not applicable No relevant impurities 1 May 2009 31 August 2024 No 1107/2009, the conclusions of the review reports 206040 – Culture on Trichoderma harzianum T-22 (SANCO/1839/2008) collection No IMI and ITEM 908 (SANCO/1840/208) respectively and 206040, ATCC in particular Appendices I and II thereof, as finalised 20476 in the Standing Committee on the Food Chain and Ani­ mal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.’

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

ELI:

http://data.europa.eu/eli/reg_impl/2024/1280/oj 3/4 OJ L,

3.5.2024 EN(2) row 230, Fatty acids C7 to C20, is replaced by the following:

Common Name, Identification No IUPAC Name Purity(1) Date of approval Expiration of approval Specific provisions Numbers ‘230 Fatty acids C7 to C20 CAS No 112-05-0 (Pelargonic Nonanoic acid ≥ 889 g/kg (Pelar­ 1 September 2009 15 December 2024 PART A Acid) gonic Acid) Caprylic Acid, Pelargonic Acid, Only uses as insecticide, acari­ 67701-09-1 (Fatty acids Capric Acid, Lauric Acid, Oleic cide, and herbicide and plant C7-C18 and C18 unsaturated Acid (ISO in each case) growth regulator may be potassium salts) ≥ 838 g/kg fatty Octanoic Acid, Nonanoic authorised.

acids 124-07-2 (Caprylic Acid) Acid, Decanoic Acid, Dodeca­ noic Acid, cis-9-Octadecenoic PART B 334-48-5 (Capric Acid) Acid (IUPAC in each case) Fatty acids, C7-C10, Me esters ≥ 99 % fatty acid For the implementation of the methyl esters uniform principles as referred to in Article 29(6) of Regulation 143-07-7 (Lauric Acid) Nonanoic acid ≥ 889 g/kg (Pelar­ 1 September 2009 31 August 2024 (EC) No 1107/2009, the con­ gonic Acid) clusions of the review report on 112-80-1 (Oleic Acid) Caprylic Acid, Pelargonic Acid, fatty acids Capric Acid, Lauric Acid, Oleic 85566-26-3 (Fatty acids (SANCO/2610/2008) and in Acid (ISO in each case) C8-C10 Me esters) particular Appendices I and II ≥ 838 g/kg fatty Octanoic Acid, Nonanoic thereof, as finalised in the 111-11-5 (Methyl octanoate) acids Acid, Decanoic Acid, Dodeca­ Standing Committee on the 110-42-9 (Methyl decanoate) noic Acid, cis-9-Octadecenoic Food Chain and Animal Health Acid (IUPAC in each case) shall be taken into account.

CIPAC No not allocated Fatty acids, C7-C10, Me esters ≥ 99 % fatty acid Conditions of use shall include, methyl esters where appropriate, risk mitiga­ tion measures.’

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

(3) in row 264, Dodemorph, in the sixth column, ‘Expiration of approval’, the date is replaced by ‘31 August 2024’.

4/4

ELI:

http://data.europa.eu/eli/reg_impl/2024/1280/oj EN OJ L,

3.5.2024