Commission Implementing Regulation (EU) 2025/2186 of 29 October 2025 concerning the renewal of the authorisation of propionic acid, sodium propionate and ammonium propionate as feed additives for all terrestrial animal species and repealing Implementing Regulations (EU) No 1222/2013 and (EU) No 305/2014

Official Journal EN of the European Union L series 2025/2186 30.10.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/2186 of 29 October 2025 concerning the renewal of the authorisation of propionic acid, sodium propionate and ammonium propionate as feed additives for all terrestrial animal species and repealing Implementing Regulations (EU) No 1222/2013 and (EU) No 305/2014 (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) Propionic acid, sodium propionate and ammonium propionate were authorised for a period of 10 years as feed additives for ruminants, pigs and poultry by Commission Implementing Regulation (EU) No 1222/2013(2)and for all animal species other than ruminants, pigs and poultry by Commission Implementing Regulation (EU) No 305/2014(3). (3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, applications were submitted for the renewal of the authorisation of propionic acid, sodium propionate and ammonium propionate as feed additives for all animal species, requesting the additives to be classified in the additive category ‘technological additives’ and in the functional group ‘silage additives’. Those applications were accompanied by the particulars and documents required under Article 14(2) of that Regulation. (4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 3 July 2024(4)and 17 September 2024(5) that propionic acid, sodium propionate and ammonium propionate remain safe for all terrestrial animal species, the consumer and the environment under the authorised conditions. Regarding user safety, it concluded that propionic acid is corrosive to the skin while sodium and ammonium propionate are also corrosive to the eyes and respiratory tract. Sodium propionate is not a skin sensitiser. Any exposure of these additives to users is considered a risk. The Authority considered that there is no need for assessing the efficacy of propionic acid, sodium propionate and ammonium propionate in the context of the renewal of the authorisation, as the applications for renewal of the authorisations do not include proposals for amending or supplementing the conditions of the original authorisations that would have an impact on the efficacy of the additives. (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 1222/2013 of 29 November 2013 concerning the authorisation of propionic acid, sodium propionate and ammonium propionate as feed additives for ruminants, pigs and poultry (OJ L 320, 30.11.2013, p. 16, ELI: http://data.europa.eu/eli/reg_impl/2013/1222/oj). (3) Commission Implementing Regulation (EU) No 305/2014 of 25 March 2014 concerning the authorisation of propionic acid, sodium propionate and ammonium propionate as feed additives for all animal species other than ruminants, pigs and poultry (OJ L 90, 26.3.2014, p. 12, ELI: http://data.europa.eu/eli/reg_impl/2014/305/oj). (4) EFSA Journal, 22(8), e8938. https://doi.org/10.2903/j.efsa.2024.8938. EFSA Journal, 22(10), e9068. https://doi. org/10.2903/j.efsa.2024.9068. (5) EFSA Journal, 22(10), e9020. https://doi.org/10.2903/j.efsa.2024.9020. ELI: http://data.europa.eu/eli/reg_impl/2025/2186/oj 1/9EN OJ L, 30.10.2025 (5) By letter of 11 September 2024, the applicant withdrew the application for the renewal of the authorisation as regards the use of propionic acid, sodium propionate and ammonium propionate for aquatic animals. (6) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the previous assessments carried out regarding the methods of analysis of propionic acid, sodium propionate and ammonium propionate as feed additives are valid and applicable for the current applications. Those previous assessments 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 opinions of 3 July 2024 and 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. (7) In view of the above, the Commission considers that propionic acid, sodium propionate and ammonium propionate satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of these additives 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 additives. (8) As a consequence of the renewal of the authorisation of propionic acid, sodium propionate and ammonium propionate as feed additives, Implementing Regulations (EU) No 1222/2013 and (EU) No 305/2014 should be repealed accordingly. (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 substances specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives, is renewed subject to the conditions laid down in that Annex. Article 2 Repeal of Implementing Regulations (EU) No 1222/2013 and (EU) No 305/2014 Implementing Regulations (EU) No 1222/2013 and (EU) No 305/2014 are repealed. Article 3 Transitional measures The feed additives propionic acid, sodium propionate and ammonium propionate, as authorised by Implementing Regulations (EU) No 1222/2013 and (EU) No 305/2014 and feed containing them, which are intended for all terrestrial animal species, and which are produced and labelled before 19 November 2026 in accordance with the rules applicable before 19 November 2025 may continue to be placed on the market and used until the stocks concerned are exhausted. 2/9 ELI: http://data.europa.eu/eli/reg_impl/2025/2186/ojEN OJ L, 30.10.2025 Article 4 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, 29 October 2025. For the Commission The President Ursula VON DER LEYEN ELI: http://data.europa.eu/eli/reg_impl/2025/2186/oj 3/9ANNEX Identifica­ Minimum Maximum tion Species or content content End of period Composition, chemical formula, Maximum number of Additive category Other provisions of description, analytical method age the feed of animal mg/kg of complete feed with authorisation additive 12 % moisture content Category: technological additives. Functional group: silage additives 1k280 Propionic acid Additive composition Pigs - - 30 000 1. In the directions for use of 19 November Propionic acid ≥ 99,5 % the additive and 2035 premixtures, the storage Characterisation of the active substance conditions shall be Propionic acid ≥ 99,5 % indicated. Poultry - - 10 000 C H O 3 6 2 CAS No: 79-09-4 2. The simultaneous use with Non-volatile residue ≤ 0,01 % when other sources of propionic dried All - - - acid shall not exceed the at 140 °C to constant weight animal permitted maximum levels species in complete feedingstuffs Aldehydes ≤ 0,1 % expressed as other for the respective animal Formaldehyde than species or category. pigs, Produced by chemical synthesis poultry and Analytical method(1) aquatic 3. Indicate in the instructions For the determination of propionic animal for use of the additive, acid in the feed additive: species premixture and related — Ion chromatography with feedingstuffs for food- conductivity detection (IC-CD) – producing animals: ‘The EN 17294 simultaneous use of different organic acids or their salts is contraindicated, where one or more of them is used at or near the maximum permitted content.’ 4. The additive shall only be used in easy to ensile fresh plant materials(2). 4/9 ELI: http://data.europa.eu/eli/reg_impl/2025/2186/oj EN OJ L, 30.10.2025Identifica­ Minimum Maximum tion Species or content content End of period Composition, chemical formula, Maximum number of Additive category Other provisions of description, analytical method age the feed of animal mg/kg of complete feed with authorisation additive 12 % moisture content Category: technological additives. Functional group: silage additives 5. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective 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) Easy to ensile forage: > 3 % soluble carbohydrates in fresh material (e.g. whole plant maize, ryegrass, brome grass or sugar beet pulp). Commission Regulation (EC) No 429/2008 (OJ L 133, 22.5.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/429/2021-03-27). ELI: http://data.europa.eu/eli/reg_impl/2025/2186/oj 5/9 OJ L, 30.10.2025 ENIdentifica­ Minimum Maximum tion Species or content content End of period Composition, chemical formula, Maximum number of Additive category Other provisions of description, analytical method age the feed of animal mg/kg of complete feed with authorisation additive 12 % moisture content Category: technological additives. Functional group: silage additives 1k281 Sodium propionate Additive composition Pigs - - 30 000(2) 1. In the directions for use of 19 November Sodium propionate ≥ 98,5 % the additive and 2035 premixtures, the storage Characterisation of the active substance conditions shall be Sodium propionate ≥ 98,5 % indicated. C 3H 5O 2Na Poultry - - 10 000(2) CAS No: 137-40-6 Loss on drying ≤ 4 % determined by 2. The simultaneous use with drying for two hours at 105 °C other sources of propionic Water insoluble ≤ 0,1 % All - - - acid shall not exceed the Produced by chemical synthesis animal permitted maximum levels species in complete feedingstuffs Analytical method(1) other for the respective animal than species or category. For the determination of sodium pigs, propionate (as total propionic acid) in poultry the feed additive: and — Ion chromatography with aquatic 3. Indicate in the instructions conductivity detection (IC-CD) – animal for use of the additive, EN 17294 species premixture and related For the determination of total sodium feedingstuffs for food- in the feed additive: producing animals: ‘The — Atomic absorption spectrometry simultaneous use of (AAS) – EN ISO 6869; or different organic acids or — Inductively coupled plasma- their salts is atomic emission spectrometry contraindicated where one (ICP-AES) – EN 15510 or more of them is used at or near the maximum permitted content.’ 4. The additive shall only be used in easy to ensile fresh plant materials(3). 6/9 ELI: http://data.europa.eu/eli/reg_impl/2025/2186/oj EN OJ L, 30.10.2025Identifica­ Minimum Maximum tion Species or content content End of period Composition, chemical formula, Maximum number of Additive category Other provisions of description, analytical method age the feed of animal mg/kg of complete feed with authorisation additive 12 % moisture content Category: technological additives. Functional group: silage additives 5. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective 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) As propionic acid. (3) Easy to ensile forage: > 3 % soluble carbohydrates in fresh material; moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrates in the fresh material in accordance with Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/429/2021-03-27). ELI: http://data.europa.eu/eli/reg_impl/2025/2186/oj 7/9 OJ L, 30.10.2025 ENIdentifica­ Minimum Maximum tion Species or content content End of period Composition, chemical formula, Maximum number of Additive category Other provisions of description, analytical method age the feed of animal mg/kg of complete feed with authorisation additive 12 % moisture content Category: technological additives. Functional group: silage additives 1k284 Ammonium Additive composition Pigs - - 30 000(2) 1. In the directions for use of 19 November propionate Preparation of ammonium the additive and 2035 propionate ≥ 19,0 %, propionic acid premixtures, the storage ≤ 80,0 % and water ≤ 30 % conditions shall be indicated. Characterisation of the active substance Poultry - - 10 000(2) Ammonium propionate C H O N 3 9 2 CAS No.: 17496-08-1 2. The simultaneous use with Produced by chemical synthesis other sources of propionic All - - - acid shall not exceed the Analytical method(1) animal permitted maximum levels species in complete feedingstuffs For the determination of propionic other for the respective animal acid and ammonium propionate (as than species or category. total propionic acid) in the feed pigs, additive: poultry — Ion chromatography with and conductivity detection (IC-CD) – aquatic 3. Indicate in the instructions EN 17294 animal for use of the additive, For the determination of total species premixture and related ammonium in the feed additive: feedingstuffs for food- — Distillation and titration – ISO producing animals: ‘The 5664 simultaneous use of different organic acids or their salts is contraindicated where one or more of them is used at or near the maximum permitted content.’ 4. The additive shall only be used in easy to ensile fresh plant materials(3). 8/9 ELI: http://data.europa.eu/eli/reg_impl/2025/2186/oj EN OJ L, 30.10.2025Identifica­ Minimum Maximum tion Species or content content End of period Composition, chemical formula, Maximum number of Additive category Other provisions of description, analytical method age the feed of animal mg/kg of complete feed with authorisation additive 12 % moisture content Category: technological additives. Functional group: silage additives 5. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective 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) As propionic acid. (3) Easy to ensile forage: > 3 % soluble carbohydrates in fresh material (e.g. whole plant maize, ryegrass, brome grass or sugar beet pulp). Commission Regulation (EC) No 429/2008 (OJ L 133, 22.5.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/429/2021-03-27). ELI: http://data.europa.eu/eli/reg_impl/2025/2186/oj 9/9 OJ L, 30.10.2025 EN