Authorisation
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.
Entry 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.
ANNEXSupplementary provisions
ANNEX
Identification number of the feed 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
3c366
L-arginine
Additive composition
L-arginine ≥ 98,5 % (on a dry matter basis)
Solid form
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Characterisation of the active substance
L-arginine produced with Corynebacterium glutamicum KCCM 80393
IUPAC name: (S)-2-amino-5-guanidinopentanoic acid
Chemical formula: C 6 H 14 N 4 O 2
CAS number: 74–79-3
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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:
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Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS/FLD or IEC-VIS)
For the determination of arginine in premixtures:
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Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS) – Commission Regulation (EC) No 152/2009 ( 2 ) , or
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Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS/FLD)
For the determination of arginine in compound feed:
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Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS) –Regulation (EC) No 152/2009
For the determination of arginine in water for drinking:
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Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS)
All animal species
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1.
In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the 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-arginine is rumen protected, when fed to ruminants.
4.
The moisture content shall be indicated on the label of the additive.
5.
The label of the additive and premixtures shall indicate the following: ‘The supplementation with L-arginine, 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 its 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.
4 February 2036
( 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 ) 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 , ELI: http://data.europa.eu/eli/reg/2009/152/oj ).