Commission Implementing Regulation (EU) 2026/93 of 15 January 2026 concerning the authorisation of L-lysine sulphate produced with Corynebacterium glutamicum CGMCC 23982 as a feed additive for all animal species

Official Journal EN of the European Union L series 2026/93 16.1.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/93 of 15 January 2026 concerning the authorisation of L-lysine sulphate produced with Corynebacterium glutamicum CGMCC 23982 as a feed additive 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, an application was submitted for the authorisation of L-lysine sulphate produced with Corynebacterium glutamicumCGMCC 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 glutamicumCGMCC 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 glutamicumCGMCC 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 glutamicumCGMCC 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 (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) EFSA Journal2025, 23(4), e9346 (https://doi.org/10.2903/j.efsa.2025.9346). (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: http://data.europa.eu/eli/reg/2005/183/oj). ELI: http://data.europa.eu/eli/reg_impl/2026/93/oj 1/4EN OJ L, 16.1.2026 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 glutamicumCGMCC 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, HAS ADOPTED THIS REGULATION: Article 1 Authorisation The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is authorised as an additive 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, 15 January 2026. For the Commission The President Ursula VON DER LEYEN (4) EFSA Journal2015, 13(7):4155, 22 p. (https://doi.org/10.2903/j.efsa.2015.4155). 2/4 ELI: http://data.europa.eu/eli/reg_impl/2026/93/ojANNEX Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, description, Maximum End of period of number of the category mg additive/kg of Other provisions additive analytical method. age authorisation feed additive of animal complete 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 — — 10 000 1. In the directions for use of 5 February 2036 L-lysine sulphate with a minimum animal the additive and L-lysine content of 55 % and a species premixtures, the storage maximum content of 21 % sulphate. conditions, the stability to heat treatment and the Solid form stability in water for Characterisation of the active substance drinking shall be indicated. L-lysine sulphate produced with Corynebacterium glutamicumCGMCC 2. The additive may be used in 23982 water for drinking. Chemical formula: C H N O -O S 12 28 4 4 4 3. Feed business operators CAS number: 60343-69-3 shall ensure that L-lysine Analytical methods(1) sulphate is rumen For the identification of sulphate in the protected, when fed to feed additive: ruminants. — European Pharmacopoeia 4. The moisture content shall monograph 20301 be indicated on the label of the additive. For the determination of lysine in the feed additive: 5. The label of the additive and — Ion-exchange chromatography premixtures shall indicate coupled to post-column the following: ‘The derivatisation and optical detection supplementation with (IEC-VIS/FLD), EN ISO 17180 L-lysine sulphate, in particular via water for For the determination of lysine in drinking, shall take into premixtures: account all essential and — Ion-exchange chromatography conditionally essential coupled to post-column amino acids in order to derivatisation and optical detection avoid nutritional (IEC-VIS/FLD), EN ISO 17180, or imbalances’. ELI: http://data.europa.eu/eli/reg_impl/2026/93/oj 3/4 OJ L, 16.1.2026 ENMinimum Maximum content content Identification Species or Name of the Composition, chemical formula, description, Maximum End of period of number of the category mg additive/kg of Other provisions additive analytical method. age authorisation feed additive of animal complete feed with a moisture content of 12 % — Ion-exchange chromatography 6. For users of the additive and coupled to post-column premixtures, feed business derivatisation and optical detection operators shall establish (IEC-VIS), Commission Regulation operational procedures and (EC) No 152/2009(2) organisational measures to address potential risks For the determination of lysine in resulting from their use. compound feed: Where those risks cannot — Ion-exchange chromatography be eliminated by such coupled to post-column procedures and measures, derivatisation and optical detection the additive and (IEC-VIS), Regulation (EC) premixtures shall be used No 152/2009 with personal protective equipment, including skin, For the determination of lysine in water eyes and breathing for drinking: protection. — 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). 4/4 ELI: http://data.europa.eu/eli/reg_impl/2026/93/oj EN OJ L, 16.1.2026