L-lysine monohydrochloride and L-lysine sulphate produced by fermentation with Corynebacterium glutamicum CGMCC 7.616

In the current application an authorisation is sought under Article 4(1) for L-lysine monohydrochloride and L-lysine sulphate produced by fermentation with Corynebacterium glutamicum CGMCC 7.616 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 additives contain as active substance L-lysine with a minimum content of 78 % and 55 % (w/w, based on dry matter) for L-lysine monohydrochloride and L-lysine sulphate respectively.
The feed additives are intended to be added into feed through premixtures (or complementary feed) or directly into compound feed and water for drinking. The Applicant did not propose any maximum or minimum lysine content in compound feed or in water for drinking.
The EURL recommends for official control the “L-lysine monohydrochloride monograph” of Food Chemical Codex (FCC) for the identification of the feed additive (L-lysine monohydrochloride) while for the identification of the sulphate ions in the feed additive (L-lysine sulphate) the EURL recommends the European Pharmacopoeia monograph 20301.
For the determination of lysine in the feed additives 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 method is listed in Commission Regulation (EC) No 152/2009 and relevant amendments.
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 additives and premixtures.
For the determination of lysine in compound feed the Applicant proposed the ring-trial validated European Union (EU) method, which is described in Commission Regulation (EC) No 152/2009 and relevant amendments. The EU 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, using an amino acid analyser or IEC coupled to post-column derivatisation and optical (VIS) detection. 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 for threonine, cyst(e)ine, methionine and lysine only. This method was further ring-trial validated by 23 laboratories, resulting in the equivalent EN ISO 13903 method, which is listed in the Regulation (EC) No 152/2009.
The following performance characteristics are 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) are reported for free and total lysine: 0.035 and 0.3 g/kg feedingstuffs, respectively.
In addition, the Applicant provided experimental evidence of the suitability of the applicability of the above-mentioned EU method (or equivalent EN ISO 13903 method) based on IEC-VIS, for the determination of lysine in the feed additives and in water for drinking.
Based on the performance characteristics available, the EURL recommends for official control the ring-trial validated European Union (EU) method (or equivalent EN ISO 13903 method) based on IEC-VIS to determine lysine in the feed additives, premixtures, compound feed and water for drinking.
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, and its further relevant amendments is not considered necessary.