L-arginine (3c361)

Recommended Method

as of:

- Commission Implementing Regulation (EU) 2016/972

For the characterisation of L-arginine in the feed additive:

- Food Chemical Codex ‘L-arginine monograph’

For the quantification of arginine in the feed additive:

- ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

For the quantification of arginine in premixtures, feed materials and compound feed:

- ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) - Commission Regulation (EC) No 152/2009

Executive Summary

In the current application authorisation is sought under Article 4(1) for L-arginine produced by fermentation with Corynebacterium glutamicum (KCTC 10423BP), 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. Authorisation is sought for all animal species. L-arginine is already authorised under Commission Regulation (EC) No 1139/2007. For the quantification of L-arginine in feed additive, premixtures and feedingstuffs the Applicant submitted the Community method (Commission Regulation (EC) No 152/2009). The method was further ring-trial validated resulting in EN ISO 13903:2005. The method is based on ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS). This method does not distinguish between the salts and the amino acid enantiomers and it is designed for feedingstuffs and premixtures. The following performance characteristics were reported for the quantification of total arginine: a relative standard deviation for repeatability (RSDr) ranging from 2.3 to 3.3% and a relative standard deviation for reproducibility (RSDR) ranging from 7.2 to 9.7%. Even if not explicitly described in the scope of the Community method, the EURL, followed the advice of several experienced National Reference Laboratories (NRLs), recommends the Community method for the quantification of arginine in the feed additive. Furthermore, for the characterisation of the feed additive, the EURL identified the methods described in the “L-arginine monograph“ of the Food Chemical Codex (FCC). Based on the performance characteristics available, the EURL recommends for official control the ring-trial validated Community method (equivalent to the EN ISO 13903:2005) based on IEC-VIS for the quantification of arginine in the feed additive, premixtures and feedingstuffs, together with the “L-arginine monograph“ of the FCC for the characterisation of the feed additive. 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) is not considered necessary.