# L_2016161EN.01001801.xml

| 18.6.2016 | EN | Official Journal of the European Union | L 161/18 |
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18.6.2016

EN

Official Journal of the European Union

L 161/18

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/972

of 17 June 2016

concerning the authorisation of L-arginine produced by Corynebacterium glutamicum KCTC 10423BP as a feed additive for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. |
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(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-arginine as a feed additive. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-arginine as a feed additive. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | That application concerns the authorisation of L-arginine produced by Corynebacterium glutamicum KCTC 10423BP as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’. |
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(3)

That application concerns the authorisation of L-arginine produced by Corynebacterium glutamicum KCTC 10423BP as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 1 December 2015 (2) that, under the proposed conditions of use, L-arginine produced by Corynebacterium glutamicum KCTC 10423BP does not have an adverse effect on animal health, human health or the environment and that it is an effective source of the amino acid arginine for all animal species; for the supplemental L-arginine to be fully efficacious in ruminants, it should be protected against degradation in the rumen. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
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(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 1 December 2015 (2) that, under the proposed conditions of use, L-arginine produced by Corynebacterium glutamicum KCTC 10423BP does not have an adverse effect on animal health, human health or the environment and that it is an effective source of the amino acid arginine for all animal species; for the supplemental L-arginine to be fully efficacious in ruminants, it should be protected against degradation in the rumen. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of that substance shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation. |
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(5)

The assessment of that substance shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(6)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

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, 17 June 2016.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  
  EFSA Journal 2016; 14(1):4345.

2

EFSA Journal

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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. |
| 3c361 | — | L-arginine | Additive composition

  Powder with a minimum content of L-arginine of 98 % (on a dry matter basis) and a maximum moisture content of 10 %

  Characterisation of the active substance

  L-arginine ((S)-2-amino-5-guanidinopentanoic acid) produced by fermentation with Corynebacterium glutamicum KCTC 10423BP
  Chemical formula: C6H14N4O2

  CAS number: 74-79-3

  Analytical method
   (1)

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






  — | Food Chemical Codex ‘L-arginine monograph’. |

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.

3c361

—

L-arginine

Additive composition

Powder with a minimum content of L-arginine of 98 % (on a dry matter basis) and a maximum moisture content of 10 %

Characterisation of the active substance

L-arginine ((S)-2-amino-5-guanidinopentanoic acid) produced by fermentation with Corynebacterium glutamicum KCTC 10423BP

Chemical formula: C6H14N4O2

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:

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

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 (2) |
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—

ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) — Commission Regulation (EC) No 152/2009 (2)

All species

| 1. | The moisture content shall be indicated on the labelling of the additive. |
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1.

The moisture content shall be indicated on the labelling of the additive.

| 2. | L-arginine may be placed on the market and used as an additive consisting of a preparation. |
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2.

L-arginine may be placed on the market and used as an additive consisting of a preparation.

8 July 2026

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(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)  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).

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