(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 and renewing such authorisation.

(2)

L-arginine produced by Corynebacterium glutamicum ATCC 13870 was authorised for 10 years as a feed additive for all animal species by Commission Regulation (EC) No 1139/2007 (2).

(3)

In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of L-arginine produced by Corynebacterium glutamicum ATCC 13870 as feed additive for all animal species, requesting this additive to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’. This application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003 and included a request to change the strain designation to Corynebacterium glutamicum NITE SD 00285.

(4)

In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-arginine produced by Corynebacterium glutamicum KCCM 80182 as a feed additive for use in feed and in water for drinking for all animal species. The application concerns the authorisation of L-arginine produced by Corynebacterium glutamicum KCCM 80182 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 additive category ‘sensory additives’, functional group ‘flavouring compounds’. This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(5)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 3 April 2019 (3) and 14 May 2019 (4) that, under the proposed conditions of use, L-arginine produced by Corynebacterium glutamicum NITE SD 00285 and by Corynebacterium glutamicum KCCM 80182 does not have an adverse effect on animal health, consumer health or the environment. It also stated for L-arginine produced by Corynebacterium glutamicum NITE SD 00285 to be irritant to skin, corrosive to eyes and hazardous upon inhalation. For L-arginine produced by Corynebacterium glutamicum KCCM 80182, it stated to be corrosive to skin and eyes. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. 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.

(6)

The Authority expressed in its opinion on L-arginine produced by Corynebacterium glutamicum KCCM 80182 a concern on the safety of the simultaneous oral administration of the amino acid via water for drinking and feed. However, the Authority did not propose a maximum content for L-arginine. Moreover, the Authority recommends supplementation with L-arginine in appropriate amounts. Thus, in the case of supplementation with L-arginine via water for drinking it is appropriate to alert the user to take into account the dietary supply with all the essential and conditionally essential amino acids.

(7)

Restrictions and conditions should be provided for to allow for a better control for L-arginine when used as flavouring. For L-arginine used as flavouring recommended content should be indicated on the label. Where such content is exceeded, certain information should be indicated on the label of premixtures.

(8)

As regards the use of L-arginine as a flavouring, the Authority states that no further demonstration of efficacy is necessary when the substance is used at the recommended dose level. The use of L-arginine as a flavouring compound is not authorised in water for drinking. At the recommended dose, L-arginine as flavouring compound is not likely to pose any concern for the dietary supply with all the essential and conditionally essential amino acids.

(9)

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.

(10)

The assessment of L-arginine produced by Corynebacterium glutamicum NITE SD 00285 and by Corynebacterium glutamicum KCCM 80182 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.

(11)

As a consequence of the renewal of the authorisation of L-arginine produced by Corynebacterium glutamicum ATCC 13870 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 1139/2007 should be repealed.

(12)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for L-arginine produced by Corynebacterium glutamicum ATCC 13870, it is appropriate to provide a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.

(13)

The fact that the use of the L-arginine is not authorised for use as a flavouring in water for drinking, does not preclude its use in compound feed, which is administered via water.

(14)

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