Identification number of the additive Name of the holder of authorisation 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 a moisture content of 12 %

Category: nutritional additives. Functional group: amino acids, their salts and analogues.

3c381 - L-isoleucine Additive composition Powder with a minimum content of L-isoleucine of 93,4 % (on a dry matter basis) All animal species - - - 1. L-isoleucine may be placed on the market and used as an additive consisting of a preparation. 2. In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment and in water shall be indicated. 3. The additive may be used via water for drinking. 4. Declaration to be made on the label of the additive and premixture: — ‘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 imbalances.’ — L-isoleucine content. 5. The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600 IU endotoxins/m3 air (3). 6. For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with personal protective equipment. 26 October 2030

Characterisation of the active substance L-isoleucine produced by fermentation with Escherichia coli FERM ABP-10641 IUPAC name: (2S,3S)-2-amino-3-methylpentanoic acid Chemical formula: C6H13NO2 CAS number: 73-32-5

Analytical method (1) For the identification of L-isoleucine in the feed additive: — Food Chemical Codex ‘L-isoleucine monograph’ For the quantification of isoleucine in the feed additive: — ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) or — ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) For the quantification of isoleucine in premixtures: — ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) or — ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Regulation (EC) No 152/2009 (2) (Annex III, F) For the quantification of isoleucine in compound feed and feed materials: — ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Regulation (EC) No 152/2009 (Annex III, F) For the quantification of isoleucine in water: — ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

3c383 - L-isoleucine Additive composition Powder with a minimum content of L-isoleucine of 90 % All animal species - - - 1. L-isoleucine may be placed on the market and used as an additive consisting of a preparation. 2. In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment and in water shall be indicated. 3. The additive may be used via water for drinking. 4. Declaration to be made on the label of the additive and premixture: — ‘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 imbalances.’ — L-isoleucine content. 26 October 2030

Characterisation of the active substance L-isoleucine produced by fermentation with Corynebacterium glutamicum KCCM 80189 IUPAC name: (2S,3S)-2-amino-3-methylpentanoic acid Chemical formula: C6H13NO2 CAS number: 73-32-5

Analytical method (1) For the identification of L-isoleucine in the feed additive: — Food Chemical Codex ‘L-isoleucine monograph’ For the quantification of isoleucine in the feed additive: — ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) or — ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) For the quantification of isoleucine in premixtures: — ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) or — ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Regulation (EC) No 152/2009 (Annex III, F) For the quantification of isoleucine in compound feed and feed materials: — ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Regulation (EC) No 152/2009 (Annex III, F) For the quantification of isoleucine in water: — ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

Category: Sensory additives. Functional group: Flavouring compounds

3c381 - L-isoleucine Additive composition Powder with a minimum content of L-isoleucine of 93,4 % (on a dry matter basis) All animal species - - 1. L-isoleucine may be placed on the market and used as an additive consisting of a preparation. 2. The additive shall be incorporated into the feed in the form of a premixture. 3. In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated. 4. 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.’ 5. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 25 mg/kg. 6. The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600 IU endotoxins/m3 air (3). 7. For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential by inhalation. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with personal protective equipment. 26 October 2030

Characterisation of the active substance L-isoleucine) produced by fermentation with Escherichia coli FERM ABP-10641 IUPAC name: (2S,3S)-2-amino-3-methylpentanoic acid Chemical formula: C6H13NO2 CAS number: 73-32-5