L-arginine produced by fermentation with Escherichia coli CGMCC 7.401

In the current application an authorisation is sought under Article 4 for L-arginine produced by fermentation with Escherichia coli CGMCC 7.401 under the category/functional groups 3(c) 'nutritional additives'/'amino acids, their salts and analogues', according to Annex I of Regulation (EC) No 1831/2003. Specifically, the authorisation is sought for all animal species.
According to the Applicant, L-arginine has a minimum purity (mass fraction) of 98.5 %. The feed additive is intended to be mixed either into premixtures, incorporated through complementary feed or added directly to compound feed and water. However, the Applicant did not propose any minimum or maximum content of L-arginine in compound feed.
For the determination of arginine in compound feed the Applicant submitted the ring-trial validated European Union (EU) method based on ion-exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS). The method is described in Regulation (EC) No 152/2009 as last amended by the recently published Commission Implementing Regulation (EU) 2024/771. The method is intended for the analysis of premixtures and compound feed, it does not distinguish between the salts of amino acids and cannot differentiate the amino acid enantiomers. The following performance characteristics were reported for the quantification of total arginine in feed: a relative standard deviation for repeatability (RSD_r) ranging from 2.3 to 3.3 % and a relative standard deviation for reproducibility (RSD_R) ranging from 7.2 to 9.7 %. Furthermore, the EURL recommended in the frame of several dossiers the EU method for the determination of arginine in feed additives and water. Finally, the EURL found the “L-arginine monograph“ of the Food Chemical Codex (FCC), where different tests (including the test based on an optical rotation) are used for the identification of L-arginine in the feed additive.
Based on the available data, the EURL recommends for official control (i) the "L-arginine monograph" of the Food Chemical Codex (FCC) for the identification of L-arginine in the feed additive and (ii) the European Union method based on IEC-VIS for the quantification of arginine in the feed additive, premixtures, compound feed 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.