L-lysine sulphate produced by fermentation with Corynebacterium glutamicum KCCM 80368

In the current application an authorisation is sought under Article 4(1) for L-lysine sulphate produced by fermentation with genetically modified Corynebacterium glutamicum KCCM 80368, 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 55.0 % (w/w, based on dry matter).
L-lysine sulphate is intended to be added to feed through premixtures or directly into compound feed. However, the Applicant did not propose a minimum or maximum L-lysine content in compound feed.
For the identification of the sulphate ions in the feed additive (L-lysine sulphate) the EURL recommends for official control the European Pharmacopoeia monograph (Ph. Eur. 01/2008:20301).
For the determination of lysine in the feed additive the EURL is aware of the ring-trial validated method EN ISO 17180:2013 dedicated for the determination of free lysine, methionine and threonine in commercial amino acid products and premixtures. The method is 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 following performance characteristics were reported for the determination of lysine: a relative standard deviation for repeatability (RSDr) ranging from 0.7 to 1.7 % and a relative standard deviation for reproducibility (RSDR) ranging from 1.5 to 2.5 %.
Based on the performance characteristics available, the EURL recommends for official control the EN ISO 17180:2013 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 premixtures and compound feed the Applicant proposed and submitted 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 13903:2005 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.
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.