Utkast) Kommisjonens gjennomføringsforordning om godkjenning av L-leucin som tilsetningsstoff i fôrvarer for alle dyrearter
(Draft) Commission Implementing Regulation concerning the authorisation of L-leucine as a feed additive for all animal species
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 14.2.2020
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(1) of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-leucine produced by Escherichia coli NITE BP-02351 as a nutritional feed additive for use in feed and in water for drinking and as sensory feed additive for use in feed for all animal species. This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) This application concerns the authorisation of L-leucine produced by Escherichia coli NITE BP-02351 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’).
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 2 April 2019 that, under the proposed conditions of use, L-leucine produced by Escherichia coli NITE BP-02351 does not have an adverse effect on animal health, consumer health or the environment. It also stated that L-leucine produced by Escherichia coli NITE BP-02351 could pose an inhalation risk for the users of the additive. Therefore, appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.
(5) The Authority concluded that it is an effective source of the amino acid L-leucine for all animal species. For the supplemental L-leucine to be fully efficacious in ruminants, it should be protected against degradation in the rumen. The Authority expressed in a previous statement a concern over potential nutritional imbalances for amino acids, when they are administered via water for drinking. However, the Authority did not propose a maximum content for L-leucine. Thus, it is appropriate to indicate on the label of the additive, and premixtures containing it, an alert to take into account the dietary supply with all the essential and conditionally essential amino acids, particularly in the case of supplementation with L-leucine as amino acid via water for drinking.
(6) As regards the use of L-leucine 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-leucine as a flavouring compound is not authorised in water for drinking. At the recommended dose, L-leucine as flavouring compound is not likely to pose any concern for the dietary supply with all the essential and conditionally essential amino acids.
(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.
(8) The assessment of L-leucine 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.
(9) The fact that the use of the L-leucine 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.
(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed
Landbruks- og matdepartementet
Nærings- og fiskeridepartementet