Contents
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 nutritionnote, 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 1222/2013note and for all animal species other than ruminants, pigs and poultry by Commission Implementing Regulation (EU) No 305/2014note.
(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 2024note and 17 September 2024note 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.
(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 1Renewal 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 2Repeal 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 3Transitional 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.
Article 4Entry 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.
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg/kg of complete feed with 12 % moisture content | ||||||||
| Category: technological additives. Functional group: silage additives | ||||||||
| 1k280 | Propionic acid | Additive compositionPropionic acid ≥ 99,5 %Characterisation of the active substancePropionic acid ≥ 99,5 %C3H6O2CAS No: 79-09-4Non-volatile residue ≤ 0,01 % when driedat 140 °C to constant weightAldehydes ≤ 0,1 % expressed asFormaldehydeProduced by chemical synthesisAnalytical methodnoteFor the determination of propionic acid in the feed additive:Ion chromatography with conductivity detection (IC-CD) – EN 17294 | Pigs | - | - | 30000 | 1.In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2.The simultaneous use with other sources of propionic acid shall not exceed the permitted maximum levels in complete feedingstuffs for the respective animal species or category.3.Indicate in the instructions for use of the additive, premixture and related feedingstuffs for food-producing animals: ‘The 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 materialsnote.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. | 19 November 2035 |
| Poultry | - | - | 10000 | |||||
| All animal species other than pigs, poultry and aquatic animal species | - | - | - |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg/kg of complete feed with 12 % moisture content | ||||||||
| Category: technological additives. Functional group: silage additives | ||||||||
| 1k281 | Sodium propionate | Additive compositionSodium propionate ≥ 98,5 %Characterisation of the active substanceSodium propionate ≥ 98,5 %C3H5O2NaCAS No: 137-40-6Loss on drying ≤ 4 % determined by drying for two hours at 105 °CWater insoluble ≤ 0,1 %Produced by chemical synthesisAnalytical methodnoteFor the determination of sodium propionate (as total propionic acid) in the feed additive:Ion chromatography with conductivity detection (IC-CD) – EN 17294For the determination of total sodium in the feed additive:Atomic absorption spectrometry (AAS) – EN ISO 6869; orInductively coupled plasma-atomic emission spectrometry (ICP-AES) – EN 15510 | Pigs | - | - | 30000note | 1.In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2.The simultaneous use with other sources of propionic acid shall not exceed the permitted maximum levels in complete feedingstuffs for the respective animal species or category.3.Indicate in the instructions for use of the additive, premixture and related feedingstuffs for food-producing animals: ‘The 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 materialsnote.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. | 19 November 2035 |
| Poultry | - | - | 10000note | |||||
| All animal species other than pigs, poultry and aquatic animal species | - | - | - |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg/kg of complete feed with 12 % moisture content | ||||||||
| Category: technological additives. Functional group: silage additives | ||||||||
| 1k284 | Ammonium propionate | Additive compositionPreparation of ammonium propionate ≥ 19,0 %, propionic acid ≤ 80,0 % and water ≤ 30 %Characterisation of the active substanceAmmonium propionateC3H9O2NCAS No.: 17496-08-1Produced by chemical synthesisAnalytical methodnoteFor the determination of propionic acid and ammonium propionate (as total propionic acid) in the feed additive:Ion chromatography with conductivity detection (IC-CD) – EN 17294For the determination of total ammonium in the feed additive:Distillation and titration – ISO 5664 | Pigs | - | - | 30000note | 1.In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2.The simultaneous use with other sources of propionic acid shall not exceed the permitted maximum levels in complete feedingstuffs for the respective animal species or category.3.Indicate in the instructions for use of the additive, premixture and related feedingstuffs for food-producing animals: ‘The 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 materialsnote.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. | 19 November 2035 |
| Poultry | - | - | 10000note | |||||
| All animal species other than pigs, poultry and aquatic animal species | - | - | - |
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.