(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 an authorisation.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of guanidinoacetic acid and a preparation of guanidinoacetic acid. 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 guanidinoacetic acid and a preparation of guanidinoacetic acid as feed additives for chickens for fattening, chickens reared for laying, chickens reared for reproduction, turkeys for fattening and turkeys reared for reproduction, for use in feed and in water for drinking, requesting those additives to be classified in the category ‘zootechnical additives’, in the functional group ‘other zootechnical additives’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 18 November 2025 (2) that guanidinoacetic acid and the preparation of guanidinoacetic acid are safe for the target species, as well as for consumers and the environment, when used up to the maximum proposed use level of guanidinoacetic acid of 1 200 mg/kg complete feed and 600 mg/L water for drinking, under the assumption that the feed contains sufficient amounts of methyl donors (other than methionine, e.g. choline, betaine and folic acid) and vitamin B12. However, considering the variability in water intake and the fact that no margin of safety was identified for chickens for fattening, the Authority considered that the exposure via water for drinking should not exceed the maximum safe level of the additive when administered via feed only. The Authority also concluded that guanidinoacetic acid and the preparation of guanidinoacetic acid do not raise safety concerns for the user. It further concluded that guanidinoacetic acid and the preparation of guanidinoacetic acid are efficacious in the target species when used at the minimum use level of 600 mg/kg complete feed or 300 mg/L water. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the methods 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 guanidinoacetic acid and the preparation of guanidinoacetic acid satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of guanidinoacetic acid and the preparation of guanidinoacetic acid should be authorised for chickens for fattening, chickens reared for laying, chickens reared for reproduction, turkeys for fattening and turkeys reared for reproduction. However, as those additives are to be authorised for use both in feed and in water for drinking, in order to avoid any risk of exceeding the safe levels of use for the target species it is appropriate to provide that the simultaneous use of the additives in feed and in water for drinking is not permitted. In addition, it is appropriate to ensure that attention is paid to the supply with vitamin B12 and methyl donors other than methionine in the diet of the animal when using those additives, and that the amount of guanidinoacetic acid administered via water for drinking is not higher than what it would be if fed at the maximum content of 1 200 mg/kg complete feed considering the actual intake of water for drinking relative to feed by the animals.

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