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 20(1) thereof,Whereas:
(1)Commission Directive 2008/127/ECnote included pelargonic acid as an active substance in Annex I to Council Directive 91/414/EECnote.
(2)Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011note.
(3)The approval of the active substance pelargonic acid, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 1 December 2026.
(4)An application for the renewal of the approval of the active substance pelargonic acid was submitted to Greece, the rapporteur Member State, and to Austria, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012note and within the time period provided for in that Article.
(5)The applicants submitted the supplementary dossiers to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’). The rapporteur Member State considered the application admissible.
(6)The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 5 May 2020. In its draft renewal assessment report, the rapporteur Member State proposed to renew the approval of pelargonic acid.
(7)The Authority made the supplementary summary dossier available to the public. The Authority also communicated the draft renewal assessment report to the applicants and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.
(8)The Authority communicated to the Commission its conclusionnote on 29 July 2021 and its updated conclusionnote on 16 April 2025, according to which, taking into account the approval criteria laid down in Annex II to Regulation (EC) No 1107/2009, plant protection products containing pelargonic acid can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority identified risks with respect to groundwater, aquatic organisms, non-target arthropods including bees and soil organisms for some but not all representative uses evaluated, but no critical area of concern.
(9)The Commission presented a renewal report and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 13 October 2022 and 25 January 2023, respectively.
(10)The Commission invited the applicants to submit their comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicants submitted their comments, which have been carefully examined and taken into consideration.
(11)It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance pelargonic acid that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.
(12)Although the risk assessment for the renewal of the approval of the active substance pelargonic acid is based on a limited number of representative uses, this does not restrict the uses for which plant protection products containing pelargonic acid may be authorised.
(13)It is therefore appropriate to renew the approval of pelargonic acid.
(14)In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge and the outcome of the risk assessment, it is necessary to require that Member States, when authorising plant protection products containing pelargonic acid, pay particular attention to the protection of groundwater, aquatic organisms, non-target arthropods, including bees and soil organisms, including by imposing mitigation measures if appropriate, taking into account the local agroecological conditions and the modalities of use of the plant protection products.
(15)Pelargonic acid has been listed in the Annex to Implementing Regulation (EU) No 540/2011 in the same entry as several other fatty acids. Following the renewal of the approval of pelargonic acid, this entry should be modified to remove pelargonic acid, which should be listed under a specific entry.
(16)Implementing Regulation (EU) No 540/2011 should be amended accordingly.
(17)Commission Implementing Regulation (EU) 2024/2221note extended the expiry date of pelargonic acid to 1 December 2026 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date.
(18)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 1Renewal of the approval of the active substance#
The approval of the active substance pelargonic acid, as specified in Annex I to this Regulation, is renewed, subject to the conditions laid down in that Annex.
Article 2Amendment 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 3Entry into force and date of application#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.It shall apply from 1 October 2026.
Annex I
| Common Name,Identification Numbers | IUPAC Name | Puritynote | Date of approval | Expiration of approval | Specific provisions |
|---|---|---|---|---|---|
| Pelargonic acidCAS No 112-05-0CIPAC No 888 | Nonanoic acid | ≥ 889 g/kgFood grade quality as per specification E570 Fatty Acids in Commission Regulation (EU) No 231/2012note:Residue on ignition: Not more than 0,1 %Unsaponifiable matter: Not more than 1,5 %Water content: Not more than 0,2 % (Karl Fischer method)Arsenic: Not more than 3 mg/kgLead: Not more than 1 mg/kgMercury: Not more than 1 mg/kgThe following impurities are of toxicological concern and must not exceed the following levels in the technical material:Hexanoic acidHeptanoic acidOctanoic acidLimit: Sum of three impurities < 50 g/kg | 1 October 2026 | 30 September 2041 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on pelargonic acid, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of groundwater, when the substance is applied in regions where vulnerable aquifers occur under predominantly alkaline soils;the protection of aquatic organisms, non-target arthropods including bees and soil organisms.Conditions of use shall include risk mitigation measures, where appropriate. |
Annex II
(1)in Part A, entry 230 on 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 C20CAS 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 | Caprylic Acid, Capric Acid (ISO in each case)Octanoic Acid, Decanoic Acid (IUPAC in each case) | ≥ 838 g/kg fatty acids | 1 September 2009 | 1 December 2026 | 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.
(2)in Part B, the following entry is added:notenoteNoCommon Name,Identification NumbersIUPAC NamePuritynoteDate of approvalExpiration of approvalSpecific provisions‘181Pelargonic acidCAS No 112-05-0CIPAC No 888Nonanoic acid≥ 889 g/kgFood grade quality as per specification E570 Fatty Acids in Commission Regulation (EU) No 231/2012noteResidue on ignition: Not more than 0,1 %Unsaponifiable matter: Not more than 1,5 %Water content: Not more than 0,2 % (Karl Fischer method)Arsenic: Not more than 3 mg/kgLead: Not more than 1 mg/kgMercury: Not more than 1 mg/kgThe following impurities are of toxicological concern and must not exceed the following levels in the technical material:
—Hexanoic acid
—the protection of groundwater, when the substance is applied in regions where vulnerable aquifers occur under predominantly alkaline soils;
—Heptanoic acid
—the protection of aquatic organisms, non-target arthropods including bees and soil organisms.
—Octanoic acid
Limit: Sum of three impurities < 50 g/kg1 October 202630 September 2041For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on pelargonic acid, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:Conditions of use shall include risk mitigation measures, where appropriate.
The Annex to Commission Implementing Regulation (EU) No 540/2011 is amended as follows:
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