(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 L-lysine sulphate produced with Corynebacterium glutamicum CGMCC 23982. 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 L-lysine sulphate produced with Corynebacterium glutamicum CGMCC 23982 as a feed additive for use in feed and in water for drinking for all animal species, requesting that additive to be classified in the additive 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 opinion of 18 March 2025 (2) that L-lysine sulphate produced with Corynebacterium glutamicum CGMCC 23982 is 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. Due to the risk of nutritional imbalances and hygienic reasons, the Authority has concerns on the of use L-lysine sulphate in water for drinking. With regard to the high intrinsic content of sulphate in this additive, 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 produced with Corynebacterium glutamicum CGMCC 23982 in animal nutrition is safe for the consumers and the environment. It also concluded that the additive should be considered an irritant to skin, eyes and the respiratory tract. Any exposure to the additive is a risk. The Authority further concluded that the substance is 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 produced with Corynebacterium glutamicum CGMCC 23982 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance as a feed additive should be authorised. The Commission considers that the safe use of this amino acid 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 via water for drinking. When fed to ruminants, L-lysine sulphate produced with Corynebacterium glutamicum CGMCC 23982 should be protected against degradation in the rumen. Also, the Commission considers that a maximum level should be set up for L-lysine sulphate produced with Corynebacterium glutamicum CGMCC 23982 due to the potential adverse effects from the intrinsic high sulphate content in the additive. It should be set at 10 000 mg/kg of complete feed, which was regarded as safe in 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,