Commission Implementing Regulation (EU) 2020/1033 of 15 July 2020 concerning the renewal of the authorisation of L-arginine produced by Corynebacterium glutamicum ATCC 13870 and the authorisation of L-arginine produced by Corynebacterium glutamicum KCCM 80182 as feed additives for all animal species, and repealing Regulation (EC) No 1139/2007 (Text with EEA relevance)

Article 1

1. The authorisation of L-arginine produced by Corynebacterium glutamicum ATCC 13870, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is renewed subject to the conditions laid down in the Annex.

2. L-arginine produced by Corynebacterium glutamicum KCCM 80182, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, and in the additive category ‘sensory additives’, functional group ‘flavouring compounds’ is authorised as an additive in animal nutrition subject to the conditions laid down in the Annex.

Article 2

   L-arginine produced by Corynebacterium glutamicum ATCC 13870 and premixtures containing it, which are produced and labelled before 5 February 2021 in accordance with the rules applicable before 5 August 2020 may continue to be placed on the market and used until the existing stocks are exhausted.
   Feed materials and compound feed containing the substances referred to in point 1, which are produced and labelled before 5 August 2021 in accordance with the rules applicable before 5 August 2020 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
   Feed materials and compound feed containing the substances referred to in point 1, which are produced and labelled before 5 August 2022 in accordance with the rules applicable before 5 August 2020 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

Article 3

Regulation (EC) No 1139/2007 is repealed.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

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
3c364
-
L-arginine
Additive composition:
Powder with a minimum content of L-arginine of 98 % (on a dry matter basis) and a maximum content of 15 % water
All animal species
-
-
-
1.
L-arginine may be placed on the market and used as an additive consisting of a preparation.
2.
In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.
3.
The moisture content shall be indicated on the label of the additive.
4.
For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks for the eyes and skin and 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.
5 August 2030
Characterisation of the active substance:
L-arginine ((S)-2-amino-5-guanidinopentanoic acid) produced by fermentation with Corynebacterium glutamicum NITE SD 00285.
Chemical formula: C6H14N4O2
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:
—
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 (Annex III, F)
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
All animal species
-
-
-
1.
L-arginine may be placed on the market and used as an additive consisting of a preparation.
2.
The additive may also be 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 conditionally 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 for skin and eyes. 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.
5 August 2030
Characterisation of the active substance:
L-arginine ((S)-2-amino-5-guanidinopentanoic acid) produced by fermentation with Corynebacterium glutamicum KCCM 80182
Chemical formula: C6H14N4O2
CAS number: 74-79-3
Analytical method
( 2 ) :
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 (Annex III, F)
Category: Sensory additives. Functional group: Flavouring compounds
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
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.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 for skin and eyes. 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.
5 August 2030
Characterisation of the active substance:
L-arginine ((S)-2-amino-5-guanidinopentanoic acid) produced by fermentation with Corynebacterium glutamicum KCCM 80182
Chemical formula: C6H14N4O2
CAS number: 74-79-3
Flavis 17.003
Analytical method
( 3 ) :
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 (Annex III, F).
( 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
( 2 )   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
( 3 )   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

Schedules & Appendices

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