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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 such an authorisation.
(2)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-isoleucine produced with Corynebacterium glutamicum CCTCC M 2022764. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3)The application concerns the authorisation of L-isoleucine produced with Corynebacterium glutamicum CCTCC M 2022764 as a feed additive for use in feed and in water for drinking for all animal species, requesting that additive to be classified in the additive category ‘nutritional additives’ and in the functional group ‘amino acids, their salts and analogues’.
(4)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 January 2026note that the use of L-isoleucine produced with Corynebacterium glutamicum CCTCC M 2022764 in feed is safe for the target species when supplemented in appropriate amounts to the diet according to their nutritional needs. However, due to the risk of nutritional imbalances and hygienic reasons, the Authority has concerns on the use of that substance in water for drinking. The Authority also concluded that the use of L-isoleucine produced with Corynebacterium glutamicum CCTCC M 2022764 in animal nutrition is safe for the consumers and the environment. In the absence of data, it could not conclude on the potential of the additive to be irritant to skin and/or eyes and to be a skin sensitiser. The Authority further concluded that the substance is regarded as an efficacious source of the amino acid L-isoleucine for non-ruminant nutrition. For supplemental L-isoleucine to be as efficacious in ruminants as in non-ruminant species, it should be protected against degradation in the rumen. The Authority did not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5)In view of the above, the Commission considers that L-isoleucine produced with Corynebacterium glutamicum CCTCC M 2022764 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance as a feed additive should be authorised. The Commission considers that possible hygiene risks related to the use of this amino acid in water for drinking are to be addressed by feed business operators under their obligations to ensure compliance with the relevant hygiene requirements laid down in Regulation (EC) No 183/2005 of the European Parliament and of the Councilnote. When fed to ruminants, L-isoleucine produced with Corynebacterium glutamicum CCTCC M 2022764 should be protected against degradation in the rumen. It is appropriate to alert the user to take into account the dietary supply with all the essential and conditionally essential amino acids, in particular in the case of supplementation with L-isoleucine via water for drinking. 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.
(6)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 1Authorisation#
The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2Entry 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 additive | Name of the 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 | ||||||||
| 3c384ii | L-isoleucine | Additive compositionL-isoleucineSolid formCharacterisation of the active substanceL-isoleucine ≥ 90 % (on a dry matter basis) produced with Corynebacterium glutamicum CCTCC M 2022764IUPAC name: (2S,3S)-2-amino-3-methylpentanoic acidChemical formula: C6H13NO2CAS number: 73-32-5Analytical methodnoteFor the identification of L-isoleucine in the feed additive:Food Chemical Codex L-isoleucine monograph;For the determination of isoleucine in the feed additive:Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS/FLD or IEC-VIS);For the determination of isoleucine in premixtures:Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS/FLD) orIon-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009;For the determination of isoleucine in compound feed:Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS), Regulation (EC) No 152/2009;For the determination of isoleucine in water for drinking:Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS). | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions, stability to heat treatment and stability in water for drinking shall be indicated.2. The additive may be used via water for drinking.3. Feed business operators shall ensure that L-isoleucine is rumen protected, when fed to ruminants.4. The moisture content shall be indicated on the label of the additive.5. The labelling of the additive and premixtures shall indicate the following: The supplementation with L-isoleucine, in particular via water for drinking, shall take into account all essential and conditionally essential amino acids in order to avoid nutritional 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 skin, eye and breathing protective equipment. | 11.10.2036 |
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