Commission Implementing Regulation (EU) 2022/1469 of 5 September 2022 concerning the authorisation of L-lysine sulphate produced by Escherichia coli CGMCC 7.398 as a feed additive for all animal species (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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 a feed additive in animal nutrition subject to the conditions laid down in that Annex.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEX Identification number of the additive Name of the holder of authorisation 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. 3c323i L-lysine sulphate Additive composition Preparation of L-lysine with a content of: — lysine ≥ 55,0 % — sulphate ≥ 18,0 % Solid form All species - - 10 000 1. The L-lysine content shall be indicated on the labelling of the additive. 2. Declarations to be made on the labelling of the additive and premixtures: ‘The supplementation with L-lysine should take into account all essential and conditional essential amino acids in order to avoid imbalances.’ 3. The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600 IU endotoxins/m 3 air ( 2 ) . 4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation. Where those risks cannot be eliminated or reduced to a minimum level by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eyes and breathing protection. 26.9.2032 Characterisation of the active substance L-lysine sulphate produced by fermentation with Escherichia coli CGMCC 7.398 Chemical formula: C 12 H 28 N 4 O 4 -O 4 S CAS number: 60343-69-3 Analytical methods ( 1 ) For the quantification of lysine in the feed additive and premixtures containing more than 10 % lysine: — ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) – EN ISO 17180 For the identification of sulphate in the feed additive: — European Pharmacopoeia Monograph 20301 For the quantification of lysine in premixtures, compound feed and feed materials: — ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) – Commission Regulation (EC) No 152/2009 (Annex III, F). ( 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 ) Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA ( EFSA Journal 2018;16(10):5458); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).
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