(Utkast) Kommisjonens gjennomføringsforordning om godkjenningen av L-arginin produsert av Corynebacterium glutamicum KCCM 80099 som et fôrtilsetningsstoff til alle dyrearter
(Draft) Commission Implementing Regulation concerning the authorisation of L-arginine produced by Corynebacterium glutamicum KCCM 80099 as a feed additive for all animal species
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 22.12.2017
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(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 produced by Corynebacterium glutamicum KCCM 80099 as a feed additive for use in feed and in water for drinking. 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 KCCM 80099 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 17 May 2017 that, under the proposed conditions of use, L-arginine produced by Corynebacterium glutamicum KCCM 80099 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.
(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 the safety of L-arginine when administered 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, it is in the case of supplementation with L-arginine, particularly via drinking water appropriate to alert the user to take into account the dietary supply with all the essential and conditionally essential amino acids.
(6) 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.
(7) The assessment of L-arginine produced by Corynebacterium glutamicum KCCM 80099 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.
(8) 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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