L-tryptophan produced by fermentation with Corynebacterium glutamicum KCCM 80530

In the current application an authorisation is sought under Article 4(1) for L-tryptophan produced by fermentation with Corynebacterium glutamicum KCCM 80530 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 L-tryptophan with a minimum purity of 98 % (w/w based on dry matter). The feed additive is intended to be added directly to compound feed or through premixtures and complementary feed, and premixtures. However, the Applicant did not propose a minimum or maximum L-tryptophan content in compound feed.
For the identification of L-tryptophan in the feed additive, the EURL recommends the “L-tryptophan” monograph of the Food Chemical Codex (FCC), where different tests including one based on optical rotation for an enantiomer-specific identification are described.
For the determination of tryptophan in the feed additive, premixtures and compound feed, the Applicant proposed the ring-trial validated European Union (EU) method based on high performance liquid chromatography (HPLC) with fluorescence detection (FLD), which is described in Commission Regulation (EC) No 152/2009. The method is applicable for the determination of free (synthetic and natural) and total (peptide-bound and free) tryptophan in feed and it does not distinguish between the amino acid enantiomers.
Furthermore, the EURL is aware of the ring-trial validated method EN ISO 13904 based on HPLC-FLD which is identical to the one described in Commission Regulation (EC) No 152/2009 for compound feed and which is dedicated for the determination of free tryptophan in commercial products and premixtures and for the determination of free and total tryptophan in compound feed. This method is listed in Commission Regulation (EC) No 152/2009.
Based on the performance characteristics available, the EURL recommends for official control the above-mentioned two ring-trial validated methods based on HPLC-FLD to determine tryptophan in the feed additive, 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, and its further relevant amendments) is not considered necessary.