L-arginine produced by fermentation with Escherichia coli CCTCC M 20231961

In the current application an authorisation is sought under Article 4(1) for L-arginine produced by fermentation with Escherichia coli CCTCC M 20231961, 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 a minimum L-arginine content of 98.5 % (w/w, based on dry matter). L-arginine is intended to be added to feed through premixtures or directly into compound feed and water. However, the Applicant did not propose a minimum or maximum L-arginine content in compound feed or water. For the identification of L-arginine in the feed additive the EURL recommends for official control “L-arginine monograph” of the Food Chemical Codex (FCC). For the determination of arginine in the feed additive 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 and it’s applicable for products containing more than 10 % of the amino acid. This method is listed in Commission Regulation (EC) No 152/2009, as last amended in 2024. Furthermore, the EURL is aware on the suitability of the above-mentioned EN ISO 17180 method for the determination of other various amino acids (arginine included) in feed additives and premixtures and consequently considers it applicable for the current product. For the determination of arginine in compound feed the Applicant proposed the ring-trial validated European Union (EU) method, based on ion-exchange chromatography (IEC) coupled to post-column derivatisation and optical (VIS) detection, which is described in the Commission Regulation (EC) No 152/2009, as last amended in 2024. The 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 and 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 for additional amino acids (arginine included) 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 were reported for the determination of arginine in animal feedingstuffs: 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 %. In addition, the experimental data provided in the frame of the batch-to-batch analysis of the feed additive and in the frame of stability studies for the feed additive and premixtures demonstrated the applicability of the above-mentioned EU method for the determination of arginine in the feed additive and premixtures. While the Applicant did not propose any method for the determination of arginine in water the Applicant provided data in the frame of stability studies, demonstrating the applicability of the EU method for the determination of arginine in water. Based on the performance characteristics and data available, the EURL recommends for official control the EN ISO 17180 method based on IEC-VIS/FLD for the determination of arginine in the feed additive and premixtures, and the ring-trial validated European Union (EU) method (or equivalent EN ISO 13903 method) based on IEC-VIS to determine 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.