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

Authorisation

Article 1

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.

Entry into force

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

ANNEXSupplementary provisions

ANNEX Identification number of the feed additive Name of the additive Composition, chemical formula, description, analytical method. Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation mg additive/kg of 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 L-lysine sulphate with a minimum L-lysine content of 55 % and a maximum content of 21 % sulphate. Solid form Characterisation of the active substance L-lysine sulphate produced with Corynebacterium glutamicum CGMCC 23982 Chemical formula: C 12 H 28 N 4 O 4 -O 4 S CAS number: 60343-69-3 Analytical methods  ( 1 ) For the identification of sulphate in the feed additive: — European Pharmacopoeia monograph 20301 For the determination of lysine in the feed additive: — Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS/FLD), EN ISO 17180 For the determination of lysine in premixtures: — Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS/FLD), EN ISO 17180, or — Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009  ( 2 ) For the determination of lysine in compound feed: — Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS), Regulation (EC) No 152/2009 For the determination of lysine in water for drinking: — Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS) All animal species — — 10 000 1. In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated. 2. The additive may be used in water for drinking. 3. Feed business operators shall ensure that L-lysine sulphate is rumen protected, when fed to ruminants. 4. The moisture content shall be indicated on the label of the additive. 5. The label of the additive and premixtures shall indicate the following: ‘The supplementation with L-lysine sulphate, in particular via water for drinking, shall take into account all essential and conditionally essential amino acids in order to avoid nutritional imbalances’. 6. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eyes and breathing protection. 5 February 2036 ( 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 ).