1. The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.
2. The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEXSupplementary provisions
ANNEX
Identification number of the 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 active substance/kg of complete feed with a moisture content of 12 %
Category: nutritional additives.
Functional group: amino acids, their salts and analogues
2b620i
L-Glutamic acid
Additive composition
L-Glutamic acid
Characterisation of the active substance
L-Glutamic acid produced by Corynebacterium glutamicum NITE BP-01681
Purity: ≥ 98 %
Chemical formula: C 5 H 9 O 4 N
CAS number: 56-86-0
Einecs number: 200-293-7
Analytical method
( 1 )
For the identification of L-glutamic acid in the feed additive:
—
Food Chemical Codex monographs: ‘L-Glutamic acid’
For the quantification of glutamic acid in the feed additive:
—
Ion-exchange chromatography coupled with post-column derivatisation and visible or fluorescence detection (IEC-VIS/FLD) or
—
Ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)
For the quantification of glutamic acid in premixtures:
—
Ion-exchange chromatography coupled with post-column derivatisation and visible or fluorescence detection (IEC-VIS/FLD) or
—
Ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F)
For the quantification of glutamic acid in feedingstuffs:
—
Ion exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F)
All animal species
-
-
-
1.
In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.
2.
The additive may be used via water for drinking.
3.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks by inhalation or dermal contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including breathing protection.
4.
Declarations to be made on the labelling of the additive and premixtures: ‘The supplementation with L-glutamic acid, in particular via water for drinking, should take into account all essential and conditionally essential amino acids in order to avoid imbalances.’
12 September 2032
Identification number of the 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 active substance/kg of complete feed with a moisture content of 12 %
Category: Sensory additives.
Functional group: Flavouring compounds
2b620i
L-Glutamic acid
Additive composition
L-Glutamic acid
Characterisation of the active substance
L-Glutamic acid produced by Corynebacterium glutamicum NITE BP-01681
Purity: ≥ 98 %
Chemical formula: C 5 H 9 O 4 N
CAS number: 56-86-0
Einecs number: 200-293-7
Analytical method
( 2 )
For the identification of L-glutamic acid in the feed additive:
—
Food Chemical Codex monographs: ‘L-Glutamic acid’
For the quantification of glutamic acid in the feed additive:
—
Ion-exchange chromatography coupled with post-column derivatisation and visible or fluorescence detection (IEC-VIS/FLD) or
—
Ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)
For the quantification of glutamic acid in premixtures:
—
Ion-exchange chromatography coupled with post-column derivatisation and visible or fluorescence detection (IEC-VIS/FLD) or
—
Ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F)
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 premixture, 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 feed 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 level of active substance in complete feed referred to in point 3.
5.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks by inhalation or dermal contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including breathing protection.
12 September 2032
Identification number of the 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 active substance/kg of complete feed with a moisture content of 12 %
Category: nutritional additives.
Functional group: amino acids, their salts and analogues
2b621ii
Monosodium glutamate
Additive composition
Monosodium glutamate
Characterisation of the active substance
Monosodium glutamate produced by Corynebacterium glutamicum NITE BP-01681
Purity: ≥ 99 %
Chemical formula: C 5 H 8 NaNO 4· H 2 O
CAS number: 6106-04-3
Einecs number: 205-538-1
Analytical method
( 3 )
For the identification of monosodium L-glutamate monohydrate in the feed additive:
—
Food Chemical Codex monographs: ‘Monosodium L-glutamate’
For the quantification of monosodium glutamate in the feed additive:
—
Ion-exchange chromatography coupled with post-column derivatisation and visible or fluorescence detection (IEC-VIS/FLD) or
—
Ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)
For the quantification of monosodium glutamate in premixtures:
—
Ion-exchange chromatography coupled with post-column derivatisation and visible or fluorescence detection (IEC-VIS/FLD) or
—
Ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F)
For the quantification of monosodium glutamate in feedingstuffs:
—
Ion exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F)
All animal species
-
-
-
1.
In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.
2.
The additive may be used via water for drinking.
3.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks by inhalation or dermal contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including breathing protection.
4.
Declarations to be made on the labelling of the additive and premixtures: ‘The supplementation with monosodium glutamate, in particular via water for drinking, should take into account all essential and conditionally essential amino acids in order to avoid imbalances.’
12 September 2032
Identification number of the 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 active substance/kg of complete feed with a moisture content of 12 %
Category: Sensory additives. Functional group:
Flavouring compounds
2b621ii
Monosodium glutamate
Additive composition
Monosodium glutamate
Characterisation of the active substance
Monosodium glutamate produced by Corynebacterium glutamicum NITE BP-01681
Purity: ≥ 99 %
Chemical formula: C 5 H 8 NaNO 4· H 2 O
CAS number: 6106-04-3
Einecs number: 205-538-1
Analytical method
( 4 )
For the identification of monosodium L-glutamate monohydrate in the feed additive:
—
Food Chemical Codex monographs: ‘Monosodium L-glutamate’
For the quantification of monosodium glutamate in the feed additive:
—
Ion-exchange chromatography coupled with post-column derivatisation and visible or fluorescence detection (IEC-VIS/FLD) or
—
Ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)
For the quantification of monosodium glutamate in premixtures:
—
Ion-exchange chromatography coupled with post-column derivatisation and visible or fluorescence detection (IEC-VIS/FLD) or
—
Ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F)
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 premixture, 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 feed 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 level of active substance in complete feed referred to in point 3.
5.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks by inhalation or dermal contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including breathing protection.
12 September 2032
( 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
( 2 ) 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
( 3 ) 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
( 4 ) 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
