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 manganese(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 manganese(II) – betaine complex as a feed additive for all animal species, to be classified in the additive 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 27 September 2023 (2) that, under the proposed conditions of use, manganese(II) – betaine complex is safe for all animal species, consumers and the environment provided that the maximum authorised levels for total manganese in feed are not exceeded. In relation to the safety for all animal species, the Authority concluded that based on the results of the tolerance study, the additive is safe for chickens for fattening when used up to the maximum authorised levels of manganese in feed, and that this conclusion can be extrapolated to all animal species and categories provided that the maximum authorised levels in the EU for total manganese in feed are not exceeded. The Authority further concluded that manganese(II) – betaine complex is a skin and respiratory sensitiser, because it contains nickel. 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 manganese in all animal species and categories. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority 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 manganese(II) – betaine complex satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised. The Commission further considers that for safety reasons the additive should be added to 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,