LegalizeCommission Implementing Regulation (EU) 2025/1787 of 8 September 2025 concerning the authorisation of L-arginine produced with Corynebacterium glutamicum KCCM 80387 as a feed additive for all animal species
Article 1
Authorisation
The substance specified in the Annex, belonging to the category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’ and to the category ‘sensory additives’, functional group ‘flavouring compounds’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2
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.
ANNEX
| 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: nutritional additives. Functional group: amino acids, their salts and analogues | ||||||||
| 3c367 | L-arginine | Additive composition L-arginine ≥ 98 % (on a dry matter basis) Solid form Characterisation of the active substance L-arginine produced with Corynebacterium glutamicum KCCM 80387 IUPAC name: (S)-2-amino-5-guanidinopentanoic acid Chemical formula: C6H14N4O2 CAS number: 74–79-3 Analytical method (1) For the identification of L-arginine in the feed additive: — Food Chemical Codex ‘L-arginine monograph’; For the determination of arginine in the feed additive and water: — Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS); For the determination of arginine in premixtures and compound feed: — Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009. | All animal species | – | – | – | 1. In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and in water shall be indicated. 2. The additive may be used via water for drinking. 3. Feed business operators shall ensure that L-arginine is rumen protected, when fed to ruminants. 4. The moisture content shall be indicated on the label of the additive. 5. The label of the additive and premixtures shall indicate the following: ‘The supplementation with L-arginine, in particular via water for drinking, shall take into account all essential and conditionally essential amino acids in order to avoid imbalances.’ 6. 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 eye and breathing protective equipment. | 29 September 2035 |
| (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. | ||||||||
| 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: Sensory additives. Functional group: Flavouring compounds | ||||||||
| 3c367 | L-arginine | Additive composition L-arginine ≥ 98 % (on a dry matter basis) Solid form Characterisation of the active substance L-arginine produced with Corynebacterium glutamicum KCCM 80387 IUPAC name: (S)-2-amino-5-guanidinopentanoic acid Chemical formula: C6H14N4O2 CAS number: 74–79-3 Analytical method (1) For the identification of L-arginine in the feed additive: — Food Chemical Codex ‘L-arginine monograph’; For the determination of arginine in the feed additive: — Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS); For the determination of arginine in premixtures: — Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009. | All animal species | – | – | – | 1. The additive shall be incorporated into the feed in the form of a premixture. 2. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated. 3. On the label of the additive — the following shall be indicated: ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ 4. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the content referred to in point 3. 5. The moisture content shall be indicated on the label of the additive. 6. 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 eye and breathing protective equipment. | 29 September 2035 |
| (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. |
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