(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, two applications were submitted for the authorisation of L-lysine sulphate and L-lysine monohydrochloride produced with Corynebacterium glutamicum CGMCC 7.453 respectively. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) The applications concern the authorisation of L-lysine sulphate and L-lysine monohydrochloride produced with Corynebacterium glutamicum CGMCC 7.453 as feed additives for use in feed and in water for drinking for all animal species, requesting those additives to be classified in the category ‘nutritional additives’ and in the functional group ‘amino acids, their salts and analogues’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 18 March 2025 (2) that L-lysine sulphate and L-lysine monohydrochloride produced with Corynebacterium glutamicum CGMCC 7.453 are safe for the target species when administered via feed. The use of lysine ‘per se’ will not raise safety concerns for the target animals provided it is supplemented in appropriate amounts to the diets. The Authority has concerns on the of use L-lysine sulphate and L-lysine monohydrochloride in water for drinking. With regard to the high intrinsic content of sulphate in L-lysine sulphate, the Authority considers that, when using the additive, the formulation of the complete feed should carefully take into account the maximum tolerable level of total sulphur. The contribution of sulphur/sulphate present in water for drinking to the total sulphur intake should also be considered. The Authority concluded that the use of L-lysine sulphate and L-lysine monohydrochloride produced with Corynebacterium glutamicum CGMCC 7.453 in animal nutrition is safe for the consumers and for the environment. It also concluded that the additives should be considered as irritants to skin, eyes and the respiratory tract. The Authority further concluded that the substances are regarded as an efficacious source of the essential amino acid L-lysine for non-ruminant animal species and that for the supplemental L-lysine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen. 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 L-lysine sulphate and L-lysine monohydrochloride produced with Corynebacterium glutamicum CGMCC 7.453 satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of those substances as feed additives should be authorised. The Commission considers that the safe use of these amino acids in water for drinking, with regard to possible hygiene risks, is to be considered within the scope of Regulation (EC) No 183/2005 of the European Parliament and of the Council (3) laying down requirements for feed hygiene. It is appropriate to alert the user to take into account the dietary supply with all the essential and conditionally essential amino acids, in particular in the case of supplementation with L-lysine sulphate and L-lysine monohydrochloride via water for drinking. When fed to ruminants, L-lysine sulphate and L-lysine monohydrochloride produced with Corynebacterium glutamicum CGMCC 7.453 need to be protected against degradation in the rumen. Also, the Commission considers that a maximum level should be set up for L-lysine sulphate due to the potential adverse effects from the intrinsic high sulphate content in the additive. The level of 10 000 mg/kg of complete feed was regarded as safe according to the Authority’s opinion of 16 June 2015 (4) issued for another L-lysine sulphate. 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,