Commission Implementing Regulation (EU) 2025/1092 of 2 June 2025 amending Implementing Regulation (EU) No 540/2011 to update the list of active substances approved or deemed to have been approved under Regulation (EC) No 1107/2009 of the European Parliament and of the Council
Date: 2025-06-02
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: market approval, plant health control, plant health product








L_202501092EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/1092


3.6.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/1092
of 2 June 2025
         
amending Implementing Regulation (EU) No 540/2011 to update the list of active substances approved or deemed to have been approved under Regulation (EC) No 1107/2009 of the European Parliament and of the Council
(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 78(2) thereof,

Whereas:







(1)


The Annex to Commission Implementing Regulation (EU) No 540/2011 (2) lists active substances approved or deemed to have been approved under Regulation (EC) No 1107/2009.












(2)


For the active substances Adoxophyes orana granulovirus, L-ascorbic acid, Bacillus firmus I-1582, Bacillus pumilus QST 2808, bispyribac, chromafenozide, dodemorph, fenpyrazamine, flubendiamide, flumetralin, gamma-cyhalothrin, meptyldinocap, metaflumizone, penflufen, plant oils/citronella oil, pyridalyl, spinetoram, spiromesifen, spirotetramat and Zucchini Yellow Mosaic Virus – weak strain, which are currently listed in the Annex to Implementing Regulation (EU) No 540/2011, applications for renewal were either not submitted or were submitted but withdrawn and following the expiry of their respective approval periods, they are no longer approved or deemed to have been approved. Therefore, these active substances should be deleted from the Annex to Implementing Regulation (EU) No 540/2011 for the sake of clarity and transparency.












(3)


Strains T11 and IMI 206040 of Trichoderma atroviride (formerly T. harzianum) are listed together as a single entry in Part A of the the Annex to Implementing Regulation (EU) No 540/2011. For strain IMI 206040 an application for renewal was not submitted and following the expiry of its approval period, it is no longer deemed to have been approved. Therefore, this strain should be deleted from the Annex to Implementing Regulation (EU) No 540/2011 for the sake of clarity and transparency.












(4)


Capric acid, caprylic acid, fatty acids C7-C18 and C18 unsaturated potassium salts, fatty acids C8-C10 Me esters (methyl decanoate and methyl octanoate), lauric acid, oleic acid and pelargonic acid are listed together as a single entry in Part A of the the Annex to Implementing Regulation (EU) No 540/2011. For fatty acids C8-C10 Me esters (methyl decanoate and methyl octanoate), lauric acid and oleic acid applications for renewal were not submitted and following the expiry of their respective approval periods, they are no longer deemed to have been approved. Therefore, these active substances should be deleted from the Annex to Implementing Regulation (EU) No 540/2011 for the sake of clarity and transparency.












(5)


Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.












(6)


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, 2 June 2025.


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)  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).




ANNEX
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:






1.


Part A is amended as follows:






(1)


entry 240, plant oils/citronella oil and entry 264, dodemorph are deleted;










(2)








(a)


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











Number


Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Expiration of approval


Specific provisions




‘204


Trichoderma atroviride
(formerly T. harzianum)
STRAIN: T-11
Culture collection: No
Spanish type culture collection CECT 20498, identical with IMI 352941


Not applicable


No relevant impurities


1 May 2009


30 November 2026


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 report on Trichoderma atroviride (formerly T. harzianum) T-11 (SANCO/1841/2008), 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.’














(b)


entry 230, fatty acids C7 to C20 is replaced by the following entry:











Number


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)
CAS No 67701-09-1 (Fatty acids C7-C18 and C18 unsaturated potassium salts)
124-07-2 (Caprylic Acid)
334-48-5 (Capric Acid)
CIPAC No not allocated


Nonanoic acid
Caprylic Acid, Capric Acid (ISO in each case)
Octanoic Acid, Decanoic Acid (IUPAC in each case)


≥ 889 g/kg (Pelargonic Acid)
≥ 838 g/kg fatty acids


1 September 2009


1 December 2026


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.’






















2.


In Part B, the following entries are deleted:






(1)


entry 1, bispyribac;










(2)


entry 25, fenpyrazamine;










(3)


entry 26, Adoxophyes orana granulovirus;










(4)


entry 30, Zucchini Yellow Mosaic Virus – weak strain;










(5)


entry 36, Bacillus firmus I-1582;










(6)


entry 41, spiromesifen;










(7)


entry 55, penflufen;










(8)


entry 60, spirotetramat;










(9)


entry 64, pyridalyl;










(10)


entry 66, L-ascorbic acid;










(11)


entry 67, spinetoram;










(12)


entry 74, flubendiamide;










(13)


entry 75, Bacillus pumilus QST 2808;










(14)


entry 78, metaflumizone;










(15)


entry 80, meptyldinocap;










(16)


entry 81, chromafenozide;










(17)


entry 82, gamma-cyhalothrin.














3.


In Part E, entry 1, flumetralin is deleted.






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

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



ELI: http://data.europa.eu/eli/reg_impl/2025/1092/oj
ISSN 1977-0677 (electronic edition)