L-lysine sulphate produced by fermentation with Corynebacterium glutamicum CGMCC 23982

In the current application an authorisation is sought under Article 4(1) for L-lysine sulphate produced by fermentation with Corynebacterium glutamicum CGMCC 23982, under the category/functional group 3(c) 'nutritional additives'/'amino acids, their salts and analogues', according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for all animal species.
According to the Applicant, the feed additive contains an average L-lysine content of 54.4 % (w/w, based on dry matter).
L-lysine sulphate is intended to be added to feed through premixtures or directly into compound feed and water. However, the Applicant did not propose a minimum or maximum L-lysine content in compound feed or water.
For the identification of the sulphate ions in the feed additive (L-lysine sulphate) the EURL recommends for official control the European Pharmacopoeia monograph 20301.
For the determination of lysine in the feed additive and premixtures the Applicant submitted the ring-trial validated method EN ISO 17180 dedicated for the determination of free lysine, methionine and threonine in commercial amino acid products and premixtures containing more than 10 % of the amino acid. The method does not distinguish between the salts of amino acids and cannot differentiate between enantiomers. The method is listed in Commission Regulation (EC) No 152/2009, as last amended by Commission Implementing Regulation (EU) 2024/771.
The following performance characteristics are reported in the EN ISO 17180 method for the determination of lysine: a relative standard deviation for repeatability (RSD_r) ranging from 0.7 to 1.7 % and a relative standard deviation for reproducibility (RSD_R) ranging from 1.5 to 2.5 %.
Based on the performance characteristics available, the EURL recommends for official control the EN ISO 17180 method for the determination of free lysine in the feed additive and premixtures.
For the determination of lysine in premixtures and compound feed the Applicant submitted the ring-trial validated European Union (EU) method, based on ion-exchange chromatography (IEC) coupled to post-column derivatisation and optical (VIS) detection, which is described in Regulation (EC) No 152/2009. The method is designed for the determination of free (synthetic and natural) and of total (peptide-bound and free) amino acids in premixtures and compound feed and it does not distinguish between the salts of amino acids and cannot differentiate between enantiomers. The EU method was initially ring-trial validated using four different matrices resulting in the equivalent EN ISO 13903 method, which is listed in the above mentioned Regulation.
The following combined performance characteristics were reported for the determination of lysine in animal feedingstuffs: RSD_r ranging from 2.1 to 3.5 % and RSD_R ranging from 3.0 to 13.1 %. Furthermore, the following limits of quantification (LOQ) were reported for free and total lysine: 0.035 and 0.3 g/kg feedingstuffs, respectively.
Based on the performance characteristics available, the EURL recommends for official control the ring-trial validated European Union (EU) method or the equivalent EN ISO 13903 method based on IEC-VIS to determine lysine in premixtures and compound feed.
For the determination of lysine in water the Applicant did not propose any method. However, in the frame of the stability studies, the Applicant applied the above-mentioned EU method based on IEC-VIS and demonstrated its applicability for the determination of lysine in water. Hence, the EURL recommends for official control the EU method based on IEC-VIS for the determination of lysine in water.
Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005, as last amended by Regulation (EU) 2015/1761) is not considered necessary.