Commission Implementing Regulation (EU) 2018/129 of 25 January 2018 concerning the authorisation of L-arginine produced by Corynebacterium glutamicum KCCM 80099 as a feed additive for all animal species (Text with EEA relevance. )

• CELEX: Implementing Regulation (EU) 2018/129
• Articles: 3

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 .

Schedules & Appendices

ANNEX

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

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 KCCM 80099.

Chemical formula: C 6 H 14 N 4 O 2

CAS number: 74-79-3

Analytical method

( 1 )

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

( 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