Commission Implementing Regulation (EU) 2025/2566 of 18 December 2025 concerning the authorisation of L-lysine sulphate and L-lysine monohydrochloride produced with Corynebacterium glutamicum CGMCC 7.453 as feed additives for all animal species

Official Journal EN of the European Union L series 2025/2566 19.12.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/2566 of 18 December 2025 concerning the authorisation of L-lysine sulphate and L-lysine monohydrochloride produced with Corynebacterium glutamicumCGMCC 7.453 as feed additives for all animal species (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition(1), and in particular Article 9(2) thereof, Whereas: (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 glutamicumCGMCC 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 glutamicumCGMCC 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. (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) EFSA Journal, 23(4), e9343. https://doi.org/10.2903/j.efsa.2025.9343. EFSA Journal, 23(4), e9345. https://doi.org/10.2903/j.efsa.2025.9345. ELI: http://data.europa.eu/eli/reg_impl/2025/2566/oj 1/6EN OJ L, 19.12.2025 (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, HAS ADOPTED THIS REGULATION: Article 1 Authorisation The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex. Article 2 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 18 December 2025. For the Commission The President Ursula VON DER LEYEN (3) Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1, ELI: https://data.europa.eu/eli/reg/2005/183/oj). (4) EFSA Journal 2015; 13(7):4155. https://doi.org/10.2903/j.efsa.2015.4155. 2/6 ELI: http://data.europa.eu/eli/reg_impl/2025/2566/ojANNEX Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, End of period of number of the category of Maximum age Other provisions additive description, analytical method. mg additive/kg of complete authorisation feed additive animal feed with a moisture content of 12 % Category: nutritional additives. Functional group: amino acids, their salts and analogues 3c330 L-lysine sulphate Additive composition All species - - 10 000 1. In the directions for use of the 8 January additive and premixtures, the 2036 L-lysine sulphate with a minimum storage conditions, the L-lysine content of 55 % and a stability to heat treatment maximum content of 21 % and the stability in water for sulphate drinking shall be indicated. Solid form —————————— 2. The additive may be used in Characterisation of the active substance water for drinking. L-lysine sulphate produced with Corynebacterium glutamicum 3. Feed business operators shall CGMCC 7.453 ensure that L-lysine sulphate Chemical formula: is rumen protected, when fed C 12H 28N 4O 4-O 4S to ruminants. CAS number: 60343-69-3 —————————— 4. The moisture content shall be Analytical methods(1) indicated on the labelling of For the identification of sulphate in the additive. the feed additive (L-lysine sulphate): 5. The label of the additive and — European Pharmacopoeia premixtures shall indicate the monograph 20301 following: ‘The supplementation with For the determination of lysine in L-lysine sulphate, in the feed additive: particular via water for — Ion-exchange chromatography drinking, shall take into coupled to post-column account all essential and derivatisation and optical conditionally essential amino detection (IEC-VIS/FLD), EN acids in order to avoid ISO 17180 nutritional imbalances.’ ELI: http://data.europa.eu/eli/reg_impl/2025/2566/oj 3/6 OJ L, 19.12.2025 ENMinimum Maximum content content Identification Species or Name of the Composition, chemical formula, End of period of number of the category of Maximum age Other provisions additive description, analytical method. mg additive/kg of complete authorisation feed additive animal feed with a moisture content of 12 % For the determination of lysine in 6. For users of the additive and premixtures: premixtures, feed business operators shall establish — Ion-exchange chromatography operational procedures and coupled to post-column organisational measures to derivatisation and optical address potential risks by detection (IEC-VIS/FLD), EN inhalation. Where those risks ISO 17180 or cannot be eliminated or — Ion-exchange chromatography reduced to a minimum level coupled to post-column by such procedures and derivatisation and optical measures, the additive and detection (IEC-VIS), premixtures shall be used Commission Regulation with personal protective (EC) 152/2009(2) equipment, including skin, eyes and breathing For the determination of lysine in protection. compound feed: — Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS), Regulation (EC) 152/2009 For the determination of lysine in water for drinking: — Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS) (1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa- evaluation-reports_en (2) Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1, ELI: http://data.europa.eu/eli/reg/ 2009/152/oj). 4/6 ELI: http://data.europa.eu/eli/reg_impl/2025/2566/oj EN OJ L, 19.12.2025Minimum Maximum content content Identification Species or Composition, chemical formula, End of period of number of the Additive category of Maximum age Other provisions description, analytical method. mg additive/kg of complete authorisation feed additive animal feed with a moisture content of 12 % Category: nutritional additives. Functional group: amino acids, their salts and analogues 3c331 L-lysine Additive composition All species - - - 1. In the directions for use of the 8 January monohy­ additive and premixtures, the 2036 L-lysine monohydrochloride with a drochloride storage conditions, the minimum content of 78 % of stability to heat treatment L-Lysine on a dry matter basis and the stability in water for Solid form drinking shall be indicated. —————————— Characterisation of the active substance 2. The additive may be used via water for drinking. L-lysine monohydrochloride produced with Corynebacterium 3. Feed business operators shall glutamicumCGMCC 7.453 ensure that L-lysine Chemical formula: C H N O monohydrochloride is 6 14 2 2 CAS number: 657-27-2 rumen protected, when fed to —————————— ruminants. Analytical methods(1) 4. The moisture content shall be For the identification of L-lysine indicated on the label of the monohydrochloride in the feed additive. additive: 5. The label of the additive and — Food Chemical Codex ‘L-lysine premixtures shall indicate the monohydrochloride following: ‘The monograph’ supplementation with L-lysine For the determination of lysine in monohydrochloride, in the feed additive: particular via water for — Ion-exchange chromatography drinking, shall take into coupled to post-column account all essential and derivatisation and optical conditionally essential amino detection (IEC-VIS/FLD), EN acids in order to avoid ISO 17180 nutritional imbalances.’ ELI: http://data.europa.eu/eli/reg_impl/2025/2566/oj 5/6 OJ L, 19.12.2025 ENMinimum Maximum content content Identification Species or Composition, chemical formula, End of period of number of the Additive category of Maximum age Other provisions description, analytical method. mg additive/kg of complete authorisation feed additive animal feed with a moisture content of 12 % For the determination of lysine in 6. For users of the additive and premixtures: premixtures, feed business operators shall establish — Ion-exchange chromatography operational procedures and coupled to post-column organisational measures to derivatisation and optical address potential risks by detection (IEC-VIS/FLD), EN inhalation. Where those risks ISO 17180 or cannot be eliminated or — Ion-exchange chromatography reduced to a minimum level coupled to post-column by such procedures and derivatisation and optical measures, the additive and detection (IEC-VIS), premixtures shall be used Commission Regulation (EC) with personal protective No 152/2009 equipment, including skin, For the determination of lysine in eyes and breathing compound feed: protection. — Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009 For the determination of lysine in water for drinking: — Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) (1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa- evaluation-reports_en 6/6 ELI: http://data.europa.eu/eli/reg_impl/2025/2566/oj EN OJ L, 19.12.2025