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Document 32019R0012
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.)
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.)
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.)
C/2018/8771
OJ L 2, 4.1.2019, p. 21–26
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
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4.1.2019 |
EN |
Official Journal of the European Union |
L 2/21 |
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)
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:
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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. |
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(2) |
In accordance with Article 7 of Regulation (EC) No 1831/2003 two applications were submitted for the authorisation of L-arginine produced by Corynebacterium glutamicum KCCM 10741P and by Escherichia coli NITE BP-02186 as a feed additive for use in feed and in water for drinking for all animal species. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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(3) |
The applications concern the authorisation of L-arginine produced by Corynebacterium glutamicum KCCM 10741P as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’ and of L-arginine produced by Escherichia coli NITE BP-02186 as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’, and in the additive category ‘sensory additives’, functional group ‘flavouring compounds’. |
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(4) |
The European Food Safety Authority (‘the Authority’) concluded in its opinions of 18 April 2018 (2) and 19 April 2018 (3) that, under the proposed conditions of use, L-arginine produced by Escherichia coli NITE BP-02186 and by Corynebacterium glutamicum KCCM 10741P does not have an adverse effect on animal health, consumer health or the environment and that no safety concerns for users would arise provided that appropriate protective measures are taken. |
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(5) |
The Authority also concluded that the additive is an effective source of the amino acid arginine for all animal species and that for the supplemental L-arginine to be fully efficacious in ruminants, it should be protected against degradation in the rumen. The Authority expressed in its opinions a concern over potential nutritional imbalances of when L-arginine is administered as amino acid via water for drinking. However, no maximum content for L-arginine is proposed by the Authority. Moreover, the Authority recommends supplementation with L-arginine in appropriate amounts. Thus, in the case of supplementation with L-arginine as amino acid via drinking water it is appropriate to alert the user to take into account the dietary supply with all the essential and conditionally essential amino acids. |
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(6) |
As regards the use as flavouring, the Authority states that no further demonstration of efficacy is necessary when used at the recommended dose. The use of L-arginine as flavouring compound is not authorised in water for drinking. At the recommended dose, L-arginine as flavouring compound is unlikely to pose any concern for the dietary supply with all the essential and conditionally essential amino acids. |
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(7) |
The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports 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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(8) |
The assessment of L-arginine shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this additive should be authorised as specified in the Annex to this Regulation. |
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(9) |
The fact that the use of the L-arginine is not authorised as flavouring in water for drinking does not preclude its use in compound feed which is administered via water. |
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(10) |
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
Authorisation
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.
Article 2
Entry into force
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, 3 January 2019.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 268, 18.10.2003, p. 29.
(2) EFSA Journal 2018;16(5):5276
(3) EFSA Journal 2018;16(5):5277
ANNEX
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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 |
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mg/kg of complete feed with a moisture content of 12 % |
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Category of nutritional additives. Functional group: amino acids, their salts and analogues. |
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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: C6H14N4O2 CAS number: 74-79-3 Analytical method (1) For the identification of L-arginine in the feed additive:
For the quantification of arginine in the feed additive and water:
For the quantification of arginine in premixtures, compound feed and feed materials:
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All animal species |
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24 January 2029 |
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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: C6H14N4O2 CAS number: 74-79-3 Analytical method (1) For the identification of L-arginine in the feed additive:
For the quantification of arginine in the feed additive and water:
For the quantification of arginine in premixtures, compound feed and feed materials:
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All animal species |
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24 January 2029 |
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Category: Sensory additives. Functional group: Flavouring compounds |
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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
Chemical formula: C6H14N4O2 CAS number 74-79-3 FLAVIS No 17.003 Method of analysis (1) For the identification of L-arginine in the feed additive:
For the quantification of arginine in the feed additive
For the quantification of arginine in premixtures, compound feed and feed materials:
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All animal species |
— |
— |
— |
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24 January 2029 |
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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