Utkast) Kommisjonens gjennomføringsforordning om godkjenning av natriumselenat som tilsetningsstoff i fôrvarer for drøvtyggere
(Draft) Commission Implementing Regulation concerning the authorisation of sodium selenate as a feed additive for ruminants
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 14.2.2019
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 sodium selenate as a feed additive for ruminants.
(3) The applicant requested sodium selenate to be classified in the additive category ‘nutritional additives’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 3 July 2019 that, under the proposed conditions of use, sodium selenate does not have adverse effects on animal health, consumer safety or the environment. It also concluded that the additive is considered a skin and eye irritant and a skin and respiratory sensitiser. 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 selenium for ruminants. 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 additives in feed submitted by the Reference Laboratory set up by Article 21 of Regulation (EC) No 1831/2003.
(5) The assessment of sodium selenate 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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