BAKGRUNN (fra kommisjonsforordningen)

(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 iron(II) – betaine complex. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) The application concerns the authorisation of iron(II) – betaine complex as a feed additive for all animal species, requesting that additive to be classified in the category ‘nutritional additives’ and in the functional group ‘compounds of trace elements’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 September 2023 (2) that, under the proposed conditions of use, iron(II) – betaine complex is safe for, consumers and the environment provided that the maximum authorised levels for total iron in feed are not exceeded. The Authority further concluded that iron(II)-betaine complex is safe for chickens for fattening. This conclusion can be extrapolated to all animal species and categories provided that the maximum authorised levels in the EU for total iron in feed are not exceeded. The Authority concluded that iron(II) – betaine complex, owing to the presence of nickel, is considered a skin and respiratory sensitiser. It is an eye irritant, but it is non-irritant to the skin. The Authority concluded that the substance is efficacious as a source of iron in all animal species and categories. The Authority did 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) In view of the above, the Commission considers that iron(II)– betaine complex satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised. The Commission further concludes that for safety reasons the additive should be incorporated in feed via premixtures. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.

(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,