Official Gazette Notification Text
Official TranscriptOfficial Journal EN of the European Union L series 2026/171 27.1.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/171 of 26 January 2026 concerning the renewal of the authorisation of fumaric acid as a feed additive for all terrestrial animal species, repealing Implementing Regulation (EU) No 1078/2013 and amending Implementing Regulation (EU) 2017/56 (Text with EEA relevance) THE EUROPEAN...
Official Journal EN of the European Union L series 2026/171 27.1.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/171 of 26 January 2026 concerning the renewal of the authorisation of fumaric acid as a feed additive for all terrestrial animal species, repealing Implementing Regulation (EU) No 1078/2013 and amending Implementing Regulation (EU) 2017/56 (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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition(1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting and renewing such authorisation.
(2) Fumaric acid was authorised for a period of 10 years for all animal species as a feed additive in the functional group ‘preservatives’ by Commission Implementing Regulation (EU) No 1078/2013(2), and in the functional group ‘flavouring compounds’ by Commission Implementing Regulation (EU) 2017/56(3).
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of fumaric acid as a feed additive for all animal species, requesting that additive to be classified in the category ‘technological additives’, functional group ‘preservatives’ and in the category ‘sensory additives’, functional group ‘flavouring compounds’. In accordance with Article 7 of Regulation (EC) No 1831/2003, another application was submitted for a new use of fumaric acid in the category ‘nutritional additives’, functional group ‘acidity regulator’. Those applications were accompanied by the particulars and documents required under Article 14(2) and Article 7(3) of that Regulation.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 September 2024(4)that fumaric acid remains safe under the authorised conditions of use for the terrestrial animals, consumers and the environment, while it could not conclude on the safety for the aquatic animals, noting that the data available on the safety of fumaric acid on aquatic animals is scarce. It also considered that the new use of the additive as an acidity regulator under the proposed conditions of use would not introduce risks, which are not already considered. The Authority also concluded that fumaric acid is irritant to skin, eyes and respiratory tract, and should be considered a skin and respiratory sensitiser. The Authority stated that there is no need for assessing the efficacy of fumaric acid for its use as a preservative and as a flavouring compound, as the application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation in this regard, while it was not in the position to conclude on its efficacy as an acidity regulator in feed.
(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) Commission Implementing Regulation (EU) No 1078/2013 of 31 October 2013 concerning the authorisation of fumaric acid as a feed additive for all animal species (OJ L 292, 1.11.2013, p. 7, ELI: http://data.europa.eu/eli/reg_impl/2013/1078/oj).
(3) Commission Implementing Regulation (EU) 2017/56 of 14 December 2016 concerning the authorisation of lactic acid, 4-oxovaleric acid, succinic acid, fumaric acid, ethyl acetoacetate, ethyl lactate, butyl lactate, ethyl 4-oxovalerate, diethyl succinate, diethyl malonate, butyl-O-butyryllactate, hex-3-enyl lactate, hexyl lactate, butyro-1,4-lactone, decano-1,5-lactone, undecano-1,5-lactone, pentano-1,4-lactone, nonano-1,5-lactone, octano-1,5-lactone, heptano-1,4-lactone and hexano-1,4-lactone as feed additives for all animal species (OJ L 13, 17.1.2017, p. 129, ELI: http://data.europa.eu/eli/reg_impl/2017/56/oj).
(4) EFSA Journal 2024, 22(10), e9019 (https://doi.org/10.2903/j.efsa.2024.9019).
ELI: http://data.europa.eu/eli/reg_impl/2026/171/oj 1/7EN OJ L, 27.1.2026
(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the previous assessment carried out regarding the methods of analysis of fumaric acid as a feed additive are valid and applicable for the current application. That previous assessment took place in the context of a new evaluation of the methods of analysis concerned performed by the Reference Laboratory, which is referred to in the Authority’s opinion of 17 September 2024, in order to take account of scientific and technological developments and to ensure a better suitability of the methods of analysis for official controls.
(6) By letter of 21 November 2024, the applicant withdrew the application for the renewal of the authorisation as regards the use of fumaric acid for aquatic animals and the application for its use as an acidity regulator.
(7) In view of the above, the Commission considers that fumaric acid satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003, as far as it concerns its use as a feed additive for terrestrial animals. Accordingly, the authorisation of that additive should be renewed. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.
(8) As a consequence of the renewal of the authorisation of fumaric acid as a feed additive for terrestrial animals, Implementing Regulation (EU) No 1078/2013 should be repealed and Implementing Regulation (EU) 2017/56 should be amended to maintain the authorisation of the additive only for the use for animal species which are not the subject of the renewal of the authorisation.
(9) 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 Renewal of the authorisation The authorisation of the substance specified in the Annex, belonging to the additive category ‘technological additives’, functional group ‘preservatives’ and to the additive category ‘sensory additives’, functional group ‘flavouring compounds’, is renewed subject to the conditions laid down in that Annex.
Article 2 Repeal of Implementing Regulation (EU) No 1078/2013 Implementing Regulation (EU) No 1078/2013 is repealed.
Article 3 Amendment to Implementing Regulation (EU) 2017/56 In the fifth column of the entry 2b08025 of the Annex to Implementing Regulation (EU) 2017/56, the words ‘All animal species’ are replaced by the words ‘Aquatic animal species’.
2/7 ELI: http://data.europa.eu/eli/reg_impl/2026/171/ojEN OJ L, 27.1.2026 Article 4 Transitional measures
1. The feed additive fumaric acid, as authorised by Implementing Regulations (EU) No 1078/2013 and (EU) 2017/56 and premixtures containing that additive, which are intended for terrestrial animal species, and which are produced and labelled before 16 August 2026 in accordance with the rules applicable before 16 February 2026, may continue to be placed on the market and used until the stocks concerned are exhausted.
2. Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 16 February 2027 in accordance with the rules applicable before 16 February 2026, may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing terrestrial animals.
3. Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 16 February 2028 in accordance with the rules applicable before 16 February 2026, may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for non-food producing terrestrial animals.
Article 5 Entry into force 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, 26 January 2026.
For the Commission The President Ursula VON DER LEYEN
ELI: http://data.europa.eu/eli/reg_impl/2026/171/oj 3/7ANNEX Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, End of period of number of the category of Maximum age Other provisions additive description, analytical method mg of additive/kg of complete authorisation feed additive animal feed with a moisture content of 12 %
Category: technological additives. Functional group: preservatives 1a297 Fumaric acid Additive composition Poultry — — 20 000 1. In the directions for use 16 February Fumaric acid Pigs other of the additive and pre 2036 Solid form than fed mixtures, the storage with milk conditions and the sta Characterisation of active substance replacers bility to heat treatment Fumaric acid ≥ 99,5 % shall be indicated.
Young 10 000(2) Produced by chemical synthesis.
C H O mammals 2. The simultaneous use of CA4 S4 No4 110-17-8 fed with fumaric acid with other milk sources of fumaric acid Analytical method(1) replacers is permitted, only if the For the determination of fumaric acid amount of fumaric acid All other — (as total fumaric acid) in the feed in feed materials and terrestrial additive, premixtures and compound compound feed is animal
feed: lower than the one species — Ion chromatography with resulting from the use conductivity detection (IC-CD) – of the additive at the EN 17294. maximum or recom mended content for the respective animal species or category.
3. Indicate in the instruc tions for use of the addi tive, premixture and related feedingstuffs for food-producing ani
mals: ‘The simultaneous use of different organic acids or their salts is contraindicated, where one or more of them is used at or near the max imum permitted con tent.’ 4/7
ELI:
http://data.europa.eu/eli/reg_impl/2026/171/oj EN OJ L,
27.1.2026Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, End of period of number of the category of Maximum age Other provisions additive description, analytical method mg of additive/kg of complete authorisation feed additive animal feed with a moisture content of 12 %
4. For users of the additive and premixtures, feed business operators shall establish opera tional procedures and organisational mea sures to address poten tial risks resulting from their use. Where those risks cannot be elimi nated by such proce dures and measures, the additive and pre mixtures shall be used with personal skin, eye and breathing protec tive equipment.
(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa- evaluation-reports_en.
(2) mg of fumaric acid per kg of milk replacer (Dry Matter 94,5 %).
ELI:
http://data.europa.eu/eli/reg_impl/2026/171/oj 5/7 OJ L,
27.1.2026 ENMinimum Maximum content content Identification Species or Name of the Composition, chemical formula, End of period of number of the category of Maximum age Other provisions additive description, analytical method mg of additive/kg of complete authorisation feed additive animal feed with a moisture content of 12 %
Category: Sensory additives. Functional group: flavouring compounds 2b08025 Fumaric acid Additive composition All animal — — — 1. The additive shall be 16 February Fumaric acid species incorporated into the 2036 Solid form other than feed in the form of a pre aquatic mixture.
Characterisation of active substance animal Fumaric acid ≥ 99,5 % species 2. In the directions for use Produced by chemical synthesis of the additive and pre C H O mixtures, the storage 4 4 4 CAS No 110-17-8 conditions and the sta FLAVIS No 08.025 bility to heat treatment shall be indicated.
Analytical method(1) For the identification of fumaric acid 3. The simultaneous use of in the feed additive and in feed fumaric acid with other
flavouring premixtures: sources of fumaric acid Gas chromatography mass is permitted, only if the spectrometry with retention time amount of fumaric acid locking GC-MS-RTL in feed materials and compound feed is lower than the one resulting from the use of the additive at the maximum or recom mended content for the respective animal species or category.
4. On the label of the addi tive the following shall
be indicated: ‘Recom mended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.
6/7
ELI:
http://data.europa.eu/eli/reg_impl/2026/171/oj EN OJ L,
27.1.2026Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, End of period of number of the category of Maximum age Other provisions additive description, analytical method mg of additive/kg of complete authorisation feed additive animal feed with a moisture content of 12 %
5. The functional group, the identification num ber, the name and the added amount of the active substance shall be indicated on the label of premixtures where the use level on the label of the premix ture would result in exceeding the level referred to in point 4.
6. For users of the additive and premixtures, feed business operators shall establish opera tional procedures and organisational mea sures to address poten tial risks resulting from their use. Where those risks cannot be elimi nated by such proce dures and measures, the additive and pre mixtures shall be used with personal skin, eye and breathing protec tive equipment.
(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa- evaluation-reports_en.
ELI:
http://data.europa.eu/eli/reg_impl/2026/171/oj 7/7 OJ L,
27.1.2026 EN