Commission Implementing Regulation (EU) 2019/12 of 3 January 2019 concerning the authorisation of L-arginine as a feed additive for all animal species (Text with EEA relevance.)

Authorisation

Article 1

1.   The substances L-arginine produced by Corynebacterium glutamicum KCCM 10741P and L-arginine produced by Escherichia coli NITE BP-02186 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 a feed additive in animal nutrition subject to the conditions laid down in that Annex. 2.   The substance L-arginine produced by Escherichia coli NITE BP-02186 specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’ is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

Entry into force

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 .

ANNEXSupplementary provisions

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. 3c363 — L-arginine Additive composition Powder with a minimum content of L-arginine of 98 % (on a dry matter basis) and a maximum content of 1,5 % water Characterisation of the active substance L-arginine ((S)-2-amino-5-guanidinopentanoic acid) produced by fermentation with Escherichia coli NITE BP-02186. 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: — 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, compound feed and feed materials: — 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, the stability to heat treatment and the stability in water for drinking shall be indicated. 4. The moisture content shall be indicated on the label of the additive. 5. Declaration to be made on the label of the additive and premixture: ‘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.’ 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, including breathing protection. 24 January 2029 3c362 — L-arginine Additive composition Powder with a minimum content of L-arginine of 98 % (on a dry matter basis) and a maximum content of 0,5 % water Characterisation of the active substance L-arginine ((S)-2-amino-5-guanidinopentanoic acid) produced by fermentation with Corynebacterium glutamicum KCCM10741P 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: — 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, compound feed and feed materials: — 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, the stability to heat treatment and the stability in water for drinking shall be indicated. 4. Declaration to be made on the label of the additive and premixture: ‘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 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, including breathing protection. 24 January 2029 Category: Sensory additives. Functional group: Flavouring compounds 3c363 — L-Arginine Additive composition Powder with a minimum content of L-arginine of 98 % (on a dry matter basis) and a maximum content of 1,5 % water Characterisation of the active substance L-arginine ((S)-2-amino-5-guanidinopentanoic acid) produced by fermentation with — Escherichia coli NITE BP-02186 Chemical formula: C 6 H 14 N 4 O 2 CAS number 74-79-3 FLAVIS No 17.003 Method of analysis  ( 1 ) For the identification of L-arginine in the feed additive: — Food Chemical Codex ‘L-arginine monograph’ For the quantification of arginine in the feed additive — ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) For the quantification of arginine in premixtures, compound feed and feed materials: — 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 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. The moisture content shall be indicated on the label of the additive. 5. On the label of the additive and premixture the following shall be indicated: ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ 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, including breathing protection. 24 January 2029 ( 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