L-arginine produced by fermentation with Corynebacterium glutamicum CGMCC 20516

Executive Summary

In the current application an authorisation is sought under Article 4(1) for L-arginine produced by fermentation with Corynebacterium glutamicum CGMCC 20516, 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 [2].
According to the Applicant, the feed additive (L-arginine) has a minimum purity (mass fraction) of 98.5 %. The feed additive is intended to be added directly into feedingstuffs or through premixtures and water for drinking with no proposed minimum or maximum limits of L-arginine in feedingstuffs.
For the identification of L-arginine in the feed additive the EURL recommends "L-arginine" monograph of the Food Chemical Codex (FCC).
For the determination of L-arginine in the feed additive, premixtures, feedingstuffs and water the Applicant proposed the ring-trial validated EN ISO 13903 method, which is equivalent to the European Union (EU) method for the determination of amino acids (Commission Regulation (EC) No 152/2009 (Annex III, F)).
The EU method is dedicated for the determination of free (synthetic and natural) and total (peptide-bound and free) amino acids (including arginine) in premixtures and feedingstuffs using an ion-exchange chromatography (IEC) coupled to post-column derivatisation and optical (visible -VIS) detection. The method does not distinguish between salts of amino acids and it cannot differentiate between enantiomers of the acids.
The EU method was further ring-trial validated for the determination of total arginine in feed resulting in the above-mentioned equivalent standard method EN ISO 13903. The following performance characteristics were reported for the determination of total arginine content in feed ranging from 4.0 to 43.5 g/kg: RSDr ranging from 2.3 to 3.3 % and RSDR ranging from 7.2 to 9.7 %.
In addition, the Applicant provided acceptable experimental data in the frame of the stability studies for the determination of arginine in the feed additive and water, thus demonstrating the applicability of the EU method for these two additional matrices.
Based on the performance characteristics available, the EURL recommends for official control the ring-trial validated European Union (EU) method based on ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS) for the determination of arginine in the feed additive, premixtures, feedingstuffs and 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.