
Article 1 
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.
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 25 January 2018.
For the Commission
The President
Jean-Claude JUNCKER
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 of nutritional additives. Functional group: amino acids, their salts and analogues
3c362 — L-arginine 
Powder with a minimum content of L-arginine of 98 % (on a dry matter basis) and a maximum content of 0,5 % water

L-arginine ((S)-2-amino-5-guanidinopentanoic acid) produced by fermentation with Corynebacterium glutamicum KCCM 80099.

Chemical formula: C6H14N4O2

CAS number: 74-79-3

For the characterisation of L-arginine in the feed additive:


— Food Chemical Codex ‘L-arginine monograph’.

For the quantification of arginine in the feed additive and water:


— ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS).

For the quantification of arginine in premixtures, feed materials and compound feed:


— ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) — Commission Regulation (EC) No 152/2009.
 All animal species    
1. L-arginine may be placed on the market and used as an additive consisting of a preparation.

2. The additive can be also used via water for drinking.

3. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment and the stability in water for drinking shall be indicated.

4. Declarations to be made on the labelling of the additive and premixtures: ‘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.’

5. 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, in particular considering that it is corrosive to skin and eyes. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.
 15 February 2028
