(Utkast) Kommisjonens gjennomføringsforordning om godkjenning av sinkkelat av metioninsulfat som tilsetningsstoff i fôrvarer for alle dyrearter
(Draft) Commission Implementing Regulation concerning the authorisation of zinc chelate of methionine sulfate as a feed additive for all animal species
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 zinc chelate of methionine sulfate. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.
(3) That application concerns the authorisation of zinc chelate of methionine sulfate 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 18 May 2017 and 4 October 2018 that, under the proposed conditions of use, zinc chelate of methionine sulfate does not have an adverse effect on animal health and consumer safety. 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 that additive does not pose an additional risk for the environment compared to other compounds of zinc and that it is an efficacious source of zinc for all animal species. 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 that additive shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are, subject to respective protective measures for the users of the additive, satisfied. Accordingly, the use of that 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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Nærings- og fiskeridepartementet