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
Date: 2024-04-30
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: market approval, plant health legislation, plant health product








L_202401280EN.000101.fmx.xml












Official Journal of the European Union


EN
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 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) 2023/689 (5) 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) 2020/1740 (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
            





(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).

(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).




ANNEX
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:











No


Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Expiration of approval


Specific provisions




‘204



Trichoderma atroviride (formerly T. harzianum)


 


 




STRAIN: T11
Culture collection: No
Spanish type culture collection CECT 20498, identical with IMI 352941


Not applicable


No relevant impurities


1 May 2009


15 April 2025


PART A
Only uses as fungicide may be authorised.
PART B
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 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 (2)



Date of approval


Expiration of approval


Specific provisions




‘230


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 acid
Caprylic 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 A
Only uses as insecticide, acaricide, and herbicide and plant growth regulator may be authorised.
PART B
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 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 acid
Caprylic 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’.






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

(2)  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
ISSN 1977-0677 (electronic edition)