Commission Implementing Regulation (EU) 2026/532 of 11 March 2026 concerning the renewal of the authorisation and the authorisation of new uses of a preparation of monensin sodium (Coxidin) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for reproduction (holder of authorisation: Huvepharma N.V.) and repealing Regulation (EC) No 109/2007 and Implementing Regulation (EU) No 140/2012

Type Implementing Regulation
Publication 2026-03-12
State In force
Text As published
Department European Commission, SANTE
Source EUR-Lex
articles 5

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

Reform history JSON API
Image omitted; see official source Official Journal of the European Union EN L series
--- --- ---
2026/532 12.3.2026

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 [^ntr1-L_202600532EN.000101-E0001], and in particular Article 9(2) thereof,

Whereas:

HAS ADOPTED THIS REGULATION:

Article 1

Renewal of authorisation

The authorisation of the preparation of monensin sodium (Coxidin) in both forms with wheat bran or with calcium carbonate, as specified in the Annex, belonging to the additive category coccidiostats and histomonostats, for use in chickens for fattening and turkeys for fattening, as well as authorisation of the preparation of monensin sodium (Coxidin) in the form with calcium carbonate, for use in chickens reared for laying, is renewed subject to the conditions laid down in that Annex.

Article 2

Authorisation

The preparation specified in the Annex, belonging to the additive category coccidiostats and histomonostats, is authorised as an additive in animal nutrition for chickens reared for laying (form with wheat bran) and turkeys reared for reproduction (forms with wheat bran or with calcium carbonate), subject to the conditions laid down in that Annex.

Article 3

Repeals

Regulation (EC) No 109/2007 and Implementing Regulation (EU) No 140/2012 are repealed.

Article 4

Transitional measures

1.

The feed additive monensin sodium (Coxidin) (forms with wheat bran or with calcium carbonate), as authorised by Regulation (EC) No 109/2007, and premixtures containing that additive, which are intended for chickens for fattening and turkeys for fattening, as well as the feed additive monensin sodium (form with calcium carbonate), authorised by Implementing Regulation (EU) No 140/2012, and premixtures containing that additive, which are intended for chickens reared for laying, and which are produced and labelled before 1 October 2026 in accordance with the rules applicable before 1 April 2026 may continue to be placed on the market and used until the existing stocks concerned are exhausted.

2.

Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are intended for chickens for fattening and turkeys for fattening (forms with wheat bran or with calcium carbonate), as well as for chickens reared for laying (form with calcium carbonate), and which are produced and labelled before 1 April 2027 in accordance with the rules applicable before 1 April 2026 may continue to be placed on the market and used until the existing stocks concerned are exhausted.

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, 11 March 2026.

For the Commission

The President

Ursula VON DER LEYEN

[^ntr1-L_202600532EN.000101-E0001]: OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

[^ntr2-L_202600532EN.000101-E0002]: Commission Regulation (EC) No 109/2007 of 5 February 2007 concerning the authorisation of monensin sodium (Coxidin) as a feed additive (OJ L 31, 6.2.2007, p. 6, ELI: http://data.europa.eu/eli/reg/2007/109/oj).

[^ntr3-L_202600532EN.000101-E0003]: Commission Implementing Regulation (EU) No 140/2012 of 17 February 2012 concerning the authorisation of monensin sodium as a feed additive for chickens reared for laying (holder of authorisation Huvepharma NV Belgium) (OJ L 47, 18.2.2012, p. 18, ELI: http://data.europa.eu/eli/reg_impl/2012/140/oj).

[^ntr4-L_202600532EN.000101-E0004]: EFSA Journal 2024;22:e8628, https://doi.org/10.2903/j.efsa.2024.8628.

[^ntr5-L_202600532EN.000101-E0005]: EFSA Journal 2025;23:e9541, https://doi.org/10.2903/j.efsa.2025.9541.

ANNEX

Identification number of the additive Name of the holder of authorisation Name of the additive (trade name) Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation Maximum residue limits (MRLs) in the relevant foodstuffs of animal origin
Identification number of the additive Name of the holder of authorisation Name of the additive (trade name) Composition, chemical formula, description, analytical method Species or category of animal Maximum age mg of active substance/kg of complete feed with a moisture content of 12 % mg of active substance/kg of complete feed with a moisture content of 12 % Other provisions End of period of authorisation Maximum residue limits (MRLs) in the relevant foodstuffs of animal origin
Category: coccidiostats and histomonostats Category: coccidiostats and histomonostats Category: coccidiostats and histomonostats Category: coccidiostats and histomonostats Category: coccidiostats and histomonostats Category: coccidiostats and histomonostats Category: coccidiostats and histomonostats Category: coccidiostats and histomonostats Category: coccidiostats and histomonostats Category: coccidiostats and histomonostats Category: coccidiostats and histomonostats
51701 Huvepharma N.V. Monensin sodium (Coxidin) Additive composition Preparation of monensin sodium equivalent to monensin activity[^ntr1-L_202600532EN.000401-E0001]: 23,7-26,2 % Forms with: — Wheat bran: q.s. or — Calcium carbonate q.s. Solid forms. Characterisation of the active substance Monensin sodium (sodium salt of polyether monocarboxylic acid), consisting of: — Monensin A sodium: sodium (2-[5-ethyltetrahydro-5-[tetrahydro-3-methyl- 5-[tetrahydro-6-hydroxy-6- (hydroxymethyl)-3,5-dimethyl- 2H-pyran-2-yl]-2-furyl]-2- furyl]-9-hydroxy-β-methoxy- α,γ,2,8-tetramethyl-1,6-dioxaspiro-[4.5]decane-7-butyric acid; C36H61NaO11; — Monensin B sodium: sodium 4-(9-hydroxy-2-(5'-(6-hydroxy-6-(hydroxymethyl)-3,5-dimethyltetrahydro-2H-pyran- 2-yl)-2,3'-dimethyloctahydro-[2,2'-bifuran]-5-yl)- 2,8-dimethyl-1,6-dioxaspiro [4.5]decan-7-yl)-3-methoxy- 2-methylpentanoate; C35H59NaO11; — Monensin C sodium: sodium 2-ethyl-4-(2-(2-ethyl-5'-(6- hydroxy-6-(hydroxymethyl)- 3,5-dimethyltetrahydro-2H- pyran-2-yl)-3'-methyloctahydro-[2,2'-bifuran]-5-yl)-9-hydroxy-2,8-dimethyl- 1,6-dioxaspiro[4.5]decan-7- yl)-3-methoxypentanoate;C37H63NaO11. From ‘monensin sodium technical substance’, composed of: — Monensin sodium equivalent to monensin activity: 32-42 %; — Perlite: 15-20 %; — Dried exhausted fermentation substrate: 38-53 %; CAS number: 22373-78-0; Produced by fermentation with Streptomyces sp. LMG S-19095. Factor composition: — Monensin A: ≥ 90 % — Monensin A + B: ≥ 95 % — Monensin C: 0,2-0,3 % Analytical method [^ntr2-L_202600532EN.000401-E0002] For the determination of monensin sodium in the feed additive: high performance liquid chromatography using post-column derivatisation coupled with photometric detection (HPLC-PCD-UV-Vis). For the determination of monensin sodium in premixtures: high performance liquid chromatography using post-column derivatisation coupled with photometric detection (HPLC-PCD-UV-Vis) – EN ISO 14183. For the determination of monensin sodium in compound feed: — High performance liquid chromatography using post-column derivatisation coupled with photometric detection (HPLC-PCD-UV-Vis) – EN ISO 14183 or — High performance liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) – EN 17299. For the determination of monensin sodium in tissues: high performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS). Chickens for fattening — 100 120 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. 2. The additive shall be incorporated in compound feed in the form of a premixture. 3. Monensin sodium shall not be mixed with other coccidiostats. 4. Indicate in the directions for use: ‘Dangerous for equines. This feedingstuff contains an ionophore: avoid simultaneous administration with tiamulin and monitor for possible adverse reactions, when used concurrently with other medicinal substances’. 5. A post-market monitoring program on the resistance of Eimeria spp. to monensin sodium shall be planned and executed by the holder of authorisation, in accordance with Commission Regulation (EC) No 429/2008[^ntr3-L_202600532EN.000401-E0003]. That post-market monitoring program shall include, as of 1 April 2031, EU wide field monitoring of resistance of Eimeria to monensin sodium and in-vitro screenings or anticoccidial sensitivity tests for single Eimeria strains collected from different chicken farms across the EU for which an indication of resistance is identified. It shall also include, as of 1 April 2033 at the latest, anticoccidial sensitivity tests (mixed infection) in chickens and turkeys covering a broad range of Eimeria strains originating from EU locations in which indications of resistance have been identified and implemented consistently across the EU. 6. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the 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 breathing and eye protective equipment, and also with skin protective equipment for the form with calcium carbonate. 1 April 2036 25 μg monensin sodium/kg of wet skin + fat 8 μg monensin sodium/kg of wet liver, wet kidney and wet muscle
51701 Huvepharma N.V. Monensin sodium (Coxidin) Additive composition Preparation of monensin sodium equivalent to monensin activity[^ntr1-L_202600532EN.000401-E0001]: 23,7-26,2 % Forms with: — Wheat bran: q.s. or — Calcium carbonate q.s. Solid forms. Characterisation of the active substance Monensin sodium (sodium salt of polyether monocarboxylic acid), consisting of: — Monensin A sodium: sodium (2-[5-ethyltetrahydro-5-[tetrahydro-3-methyl- 5-[tetrahydro-6-hydroxy-6- (hydroxymethyl)-3,5-dimethyl- 2H-pyran-2-yl]-2-furyl]-2- furyl]-9-hydroxy-β-methoxy- α,γ,2,8-tetramethyl-1,6-dioxaspiro-[4.5]decane-7-butyric acid; C36H61NaO11; — Monensin B sodium: sodium 4-(9-hydroxy-2-(5'-(6-hydroxy-6-(hydroxymethyl)-3,5-dimethyltetrahydro-2H-pyran- 2-yl)-2,3'-dimethyloctahydro-[2,2'-bifuran]-5-yl)- 2,8-dimethyl-1,6-dioxaspiro [4.5]decan-7-yl)-3-methoxy- 2-methylpentanoate; C35H59NaO11; — Monensin C sodium: sodium 2-ethyl-4-(2-(2-ethyl-5'-(6- hydroxy-6-(hydroxymethyl)- 3,5-dimethyltetrahydro-2H- pyran-2-yl)-3'-methyloctahydro-[2,2'-bifuran]-5-yl)-9-hydroxy-2,8-dimethyl- 1,6-dioxaspiro[4.5]decan-7- yl)-3-methoxypentanoate;C37H63NaO11. From ‘monensin sodium technical substance’, composed of: — Monensin sodium equivalent to monensin activity: 32-42 %; — Perlite: 15-20 %; — Dried exhausted fermentation substrate: 38-53 %; CAS number: 22373-78-0; Produced by fermentation with Streptomyces sp. LMG S-19095. Factor composition: — Monensin A: ≥ 90 % — Monensin A + B: ≥ 95 % — Monensin C: 0,2-0,3 % Analytical method [^ntr2-L_202600532EN.000401-E0002] For the determination of monensin sodium in the feed additive: high performance liquid chromatography using post-column derivatisation coupled with photometric detection (HPLC-PCD-UV-Vis). For the determination of monensin sodium in premixtures: high performance liquid chromatography using post-column derivatisation coupled with photometric detection (HPLC-PCD-UV-Vis) – EN ISO 14183. For the determination of monensin sodium in compound feed: — High performance liquid chromatography using post-column derivatisation coupled with photometric detection (HPLC-PCD-UV-Vis) – EN ISO 14183 or — High performance liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) – EN 17299. For the determination of monensin sodium in tissues: high performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS). Chickens reared for laying 16 weeks 100 120 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. 2. The additive shall be incorporated in compound feed in the form of a premixture. 3. Monensin sodium shall not be mixed with other coccidiostats. 4. Indicate in the directions for use: ‘Dangerous for equines. This feedingstuff contains an ionophore: avoid simultaneous administration with tiamulin and monitor for possible adverse reactions, when used concurrently with other medicinal substances’. 5. A post-market monitoring program on the resistance of Eimeria spp. to monensin sodium shall be planned and executed by the holder of authorisation, in accordance with Commission Regulation (EC) No 429/2008[^ntr3-L_202600532EN.000401-E0003]. That post-market monitoring program shall include, as of 1 April 2031, EU wide field monitoring of resistance of Eimeria to monensin sodium and in-vitro screenings or anticoccidial sensitivity tests for single Eimeria strains collected from different chicken farms across the EU for which an indication of resistance is identified. It shall also include, as of 1 April 2033 at the latest, anticoccidial sensitivity tests (mixed infection) in chickens and turkeys covering a broad range of Eimeria strains originating from EU locations in which indications of resistance have been identified and implemented consistently across the EU. 6. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the 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 breathing and eye protective equipment, and also with skin protective equipment for the form with calcium carbonate. 1 April 2036 25 μg monensin sodium/kg of wet skin + fat 8 μg monensin sodium/kg of wet liver, wet kidney and wet muscle
51701 Huvepharma N.V. Monensin sodium (Coxidin) Additive composition Preparation of monensin sodium equivalent to monensin activity[^ntr1-L_202600532EN.000401-E0001]: 23,7-26,2 % Forms with: — Wheat bran: q.s. or — Calcium carbonate q.s. Solid forms. Characterisation of the active substance Monensin sodium (sodium salt of polyether monocarboxylic acid), consisting of: — Monensin A sodium: sodium (2-[5-ethyltetrahydro-5-[tetrahydro-3-methyl- 5-[tetrahydro-6-hydroxy-6- (hydroxymethyl)-3,5-dimethyl- 2H-pyran-2-yl]-2-furyl]-2- furyl]-9-hydroxy-β-methoxy- α,γ,2,8-tetramethyl-1,6-dioxaspiro-[4.5]decane-7-butyric acid; C36H61NaO11; — Monensin B sodium: sodium 4-(9-hydroxy-2-(5'-(6-hydroxy-6-(hydroxymethyl)-3,5-dimethyltetrahydro-2H-pyran- 2-yl)-2,3'-dimethyloctahydro-[2,2'-bifuran]-5-yl)- 2,8-dimethyl-1,6-dioxaspiro [4.5]decan-7-yl)-3-methoxy- 2-methylpentanoate; C35H59NaO11; — Monensin C sodium: sodium 2-ethyl-4-(2-(2-ethyl-5'-(6- hydroxy-6-(hydroxymethyl)- 3,5-dimethyltetrahydro-2H- pyran-2-yl)-3'-methyloctahydro-[2,2'-bifuran]-5-yl)-9-hydroxy-2,8-dimethyl- 1,6-dioxaspiro[4.5]decan-7- yl)-3-methoxypentanoate;C37H63NaO11. From ‘monensin sodium technical substance’, composed of: — Monensin sodium equivalent to monensin activity: 32-42 %; — Perlite: 15-20 %; — Dried exhausted fermentation substrate: 38-53 %; CAS number: 22373-78-0; Produced by fermentation with Streptomyces sp. LMG S-19095. Factor composition: — Monensin A: ≥ 90 % — Monensin A + B: ≥ 95 % — Monensin C: 0,2-0,3 % Analytical method [^ntr2-L_202600532EN.000401-E0002] For the determination of monensin sodium in the feed additive: high performance liquid chromatography using post-column derivatisation coupled with photometric detection (HPLC-PCD-UV-Vis). For the determination of monensin sodium in premixtures: high performance liquid chromatography using post-column derivatisation coupled with photometric detection (HPLC-PCD-UV-Vis) – EN ISO 14183. For the determination of monensin sodium in compound feed: — High performance liquid chromatography using post-column derivatisation coupled with photometric detection (HPLC-PCD-UV-Vis) – EN ISO 14183 or — High performance liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) – EN 17299. For the determination of monensin sodium in tissues: high performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS). Turkeys for fattening Turkeys reared for reproduction 16 weeks 60 100 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. 2. The additive shall be incorporated in compound feed in the form of a premixture. 3. Monensin sodium shall not be mixed with other coccidiostats. 4. Indicate in the directions for use: ‘Dangerous for equines. This feedingstuff contains an ionophore: avoid simultaneous administration with tiamulin and monitor for possible adverse reactions, when used concurrently with other medicinal substances’. 5. A post-market monitoring program on the resistance of Eimeria spp. to monensin sodium shall be planned and executed by the holder of authorisation, in accordance with Commission Regulation (EC) No 429/2008[^ntr3-L_202600532EN.000401-E0003]. That post-market monitoring program shall include, as of 1 April 2031, EU wide field monitoring of resistance of Eimeria to monensin sodium and in-vitro screenings or anticoccidial sensitivity tests for single Eimeria strains collected from different chicken farms across the EU for which an indication of resistance is identified. It shall also include, as of 1 April 2033 at the latest, anticoccidial sensitivity tests (mixed infection) in chickens and turkeys covering a broad range of Eimeria strains originating from EU locations in which indications of resistance have been identified and implemented consistently across the EU. 6. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the 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 breathing and eye protective equipment, and also with skin protective equipment for the form with calcium carbonate. 1 April 2036 25 μg monensin sodium/kg of wet skin + fat 8 μg monensin sodium/kg of wet liver, wet kidney and wet muscle

[^ntr1-L_202600532EN.000401-E0001]: The concentration of monensin sodium is expressed as monensin activity which includes the relative biopotency in terms of ‘monensin activity’ of the different

monensin variants.

[^ntr2-L_202600532EN.000401-E0002]: 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.

[^ntr3-L_202600532EN.000401-E0003]: 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/oj).

ELI: http://data.europa.eu/eli/reg_impl/2026/532/oj

ISSN 1977-0677 (electronic edition)

Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.

This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence. EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.