L-lysine monohydrochloride, liquid L-lysine and L-lysine produced by fermentation with Corynebacterium glutamicum KCCM 80377

In the current application an authorisation is sought under Article 4 for L-lysine monohydrochloride, liquid L-lysine and L-lysine produced by fermentation with Corynebacterium glutamicum KCCM 80377, under the category/functional groups 3(c) 'nutritional additives'/'amino acids, their salts and analogues' and 2(b) 'sensory additives'/'flavouring compounds' 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 L-lysine as an active substance with a minimum purity of 78 % (w/w, based on dry matter) for L-lysine monohydrochloride and L-lysine; and 50 % (w/w) for liquid L-lysine. The feed additive is intended to be added through premixtures (or complementary feed) or directly to compound feed. A recommended maximum content of 25 mg/kg complete feed is proposed whenever the product is intended to be used as a sensory additive. Nevertheless, the Applicant did not propose any minimum or maximum content of L-lysine in compound feed when the product is intended to be used as a nutritional additive. 

For the identification of L-lysine monohydrochloride, the EURL found the specific Food Chemical Codex (FCC) “L-lysine monohydrochloride monograph”, where different tests (including the test based on an optical rotation) are used for the identification of the feed additive. 

For the determination of lysine in the feed additives, premixtures and compound feed, the Applicant proposed the ring-trial validated European Union (EU) method (Commission Regulation (EC) No 152/2009) based on ion-exchange chromatography (IEC) with optical (visible – VIS) detection, which is equivalent to EN ISO 13903 method. The EU method is designed for the determination of free (synthetic and natural) and of total (peptide-bound and free) amino acids in premixtures (containing less than 10 % of the amino acid) and compound feed. It does not distinguish between the salts of amino acids and cannot differentiate between enantiomers. Furthermore, the Applicant provided experimental evidence confirming its applicability in the above-mentioned matrices. 

Furthermore, for the determination of lysine in the feed additives and premixtures, the EURL is aware of the ring-trial validated EN ISO 17180 method based on IEC coupled to optical (visible or fluorescence – VIS/FLD) detection, which is specifically dedicated for the determination of free lysine, methionine and threonine for products 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 and relevant amendments. 

Based on the performance characteristics and available data, the EURL recommends for official control: (i) the Food Chemical Codex (FCC) “L-lysine monohydrochloride monograph” for the identification of L-lysine monohydrochloride in the feed additive; (ii) the ring-trial validated EN ISO 17180 method based on ion-exchange chromatography coupled to optical detection (IEC-VIS/FLD) to determine lysine in the feed additives and premixtures; and (iii) the European Union (EU) method (or equivalent EN ISO 13903 method) based on ion-exchange chromatography coupled to optical detection (IEC-VIS) for the determination of lysine in the feed additives, premixtures and compound feed. However, the EURL is unable to recommend the EU method (or equivalent EN ISO 13903 method) for the determination of lysine in compound feed when the feed additives are intended to be used as 'sensory additives'/'flavouring compounds', due to the fact that the maximum recommended inclusion level of L-lysine in compound feed when used as flavouring compound is lower than limits of quantification (LOQ) of lysine in compound feed as set in the EU method (or equivalent EN ISO 13903 method). 

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 relevant amendments) is not considered necessary.