Commission Implementing Regulation (EU) 2020/1397 of 5 October 2020 concerning the renewal of the authorisation of L-isoleucine produced by Escherichia coli FERM ABP-10641 as a nutritional additive, its extension of use and the authorisation of L-isoleucine produced by Corynebacterium glutamicum KCCM 80189 as a feed additive for all animal species, and repealing Regulation (EU) No 348/2010 (Text with EEA relevance)
Commission Implementing Regulation (EU) 2020/1397 of 5 October 2020 concerning the renewal of the authorisation of L-isoleucine produced by Escherichia coli FERM ABP-10641 as a nutritional additive, its extension of use and the authorisation of L-isoleucine produced by Corynebacterium glutamicum KCCM 80189 as a feed additive for all animal species, and repealing Regulation (EU) No 348/2010 (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
1. The authorisation of L-isoleucine produced by Escherichia coli FERM ABP-10641, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is renewed, extended to its use via water for drinking, subject to the conditions laid down in the Annex.
L-isoleucine produced by Escherichia coli FERM ABP-10641 belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as an additive in animal nutrition, subject to the conditions laid down in the Annex.
2. L-isoleucine produced by Corynebacterium glutamicum KCCM 80 189, 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 the Annex.
1. L-isoleucine produced by Escherichia coli FERM ABP-10641 and premixtures containing it, which are produced and labelled before 26 April 2021 in accordance with the rules applicable before 26 October 2020 may continue to be placed on the market and used until the existing stocks are exhausted.
2. Feed materials and compound feed containing L-isoleucine produced by Escherichia coli FERM ABP-10641 and premixtures containing it, which are produced and labelled before 26 October 2021 in accordance with the rules applicable before 26 October 2020 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
3. Feed materials and compound feed containing L-isoleucine produced by Escherichia coli FERM ABP-10641 and premixtures containing it, which are produced and labelled before 26 October 2022 in accordance with the rules applicable before 26 October 2020 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
ANNEX
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
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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/m 3 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/m 3 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
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))
( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
( 2 ) Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed ( OJ L 54, 26.2.2009, p. 1 ).
( 3 ) Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2020;18(2):6022); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).
