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.
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 of additive/kg of complete feed with a moisture content of 12 %
3c365
L-arginine
Additive composition
≥ 98,5 % L-arginine (on a dry matter basis) and ≤ 1 % of water
Solid form
All species
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—
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1.
The additive may be used via water for drinking.
2.
The directions for use of the additive and premixture shall indicate the storage conditions, the stability to heat treatment and the stability in water for drinking.
3.
The label of the additive and premixture shall indicate the following: ‘The supplementation with L-arginine, in particular via water for drinking, should take into account all essential and conditional essential amino acids in order to avoid imbalances.’
4.
For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including breathing, skin and eye protection.
11.4.2033
Characterisation of the active substance
L-arginine ((S)-2-amino-5-guanidinopentanoic acid) produced by Corynebacterium glutamicum CGMCC 20516
Chemical formula: C 6 H 14 N 4 O 2
CAS number: 74–79-3
Analytical method
( 1 )
For the identification of L-arginine in the feed additive:
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Food Chemical Codex ‘L-arginine monograph’.
For the determination of arginine in the feed additive and water:
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Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS).
For the determination of arginine in premixtures and complete feed:
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Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS), Commission 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://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en.