(Utkast) Kommisjonens gjennomføringsforordning om godkjenning av L-treonin framstilt av Escherichia coli CGMCC 7.232 som tilsetningsstoff i fôrvarer for alle dyrearter
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 13.4.2019
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-threonine produced by Escherichia coli CGMCC 7.232 as a feed additive for use in feed for all animal species. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation (EC).
(3) That application concerns the authorisation of L-threonine produced by Escherichia coli CGMCC 7.232 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 opinions of 2 October 2018 that, under the proposed conditions of use, L-threonine produced by Escherichia coli CGMCC 7.232 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive is considered as a potential skin sensitizer and an eye and skin irritant and stated a risk for the users of the additive upon inhalation. 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 efficacious source of the amino-acid L-threonine for all animal species and that in order to be as efficacious in ruminants as in non-ruminant species, the additive 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 L-threonine produced by Escherichia coli CGMCC 7.232 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.
(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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