L-lysine monohydrochloride produced by fermentation with Corynebacterium glutamicum CGMCC 7.453

In the current application an authorisation is sought under Article 4(1) for L-lysine monohydrochloride produced by fermentation with a genetically modified Corynebacterium glutamicum CGMCC 7.453, 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 a minimum of L-lysine content of 78.0 % (w/w, based on dry matter).
L-lysine monohydrochloride is intended to be added to compound 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.
In the frame of official control, the EURL recommends the Food Chemical Codex monograph “L-lysine monohydrochloride monograph” for the identification of L-lysine monohydrochloride in the feed additive.
For the determination of lysine in the feed additive and premixtures the Applicant proposed 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. The method does not distinguish between the salts of amino acids and cannot differentiate between enantiomers. It is applicable for products containing more than 10 % of the amino acid. The following performance characteristics were reported 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 based on IEC-VIS/FLD for the determination of lysine in the feed additive and premixtures (containing more than 10 % lysine).
For the determination of lysine in compound feed the Applicant proposed the ring-trial validated European Union (EU) method (Commission Regulation (EC) No 152/2009). The method is based on ion-exchange chromatography coupled to optical detection (IEC-VIS) and is dedicated for the analysis of free and total amino acids in premixtures and compound feed. The EU method was initially ring-trial validated using four different matrices and further validated in the second ring-trial, resulting in the EN ISO 13903 method. 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 determination (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, 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 presented experimental data obtained for the determination of lysine in water when using the IEC-VIS procedure of the above-mentioned EU method. In addition, in the frame of the authorisation of several very similar lysine products the EURL recommended another procedure, namely IEC-VIS/FLD of the above-mentioned EN ISO 17180 method for the determination of lysine in water.
Based on the available information, the EURL recommends for official control the two procedures, namely IEC-VIS or IEC-VIS/FLD of the above-mentioned methods 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.