Details
- Publication date
- 16 February 2021 (Last updated on: 2 July 2021)
Description
In the current application an authorisation is sought under Article 4(1) for monosodium L-glutamate (MSG) produced by fermentation with Corynebacterium glutamicum KCCM80187, under the category/functional group 2(b) 'sensory additives'/flavouring compounds', according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for all animal species.
According to the Applicant MSG has a minimum purity (mass fraction) of 99 %. The feed additive is intended to be added directly into feedingstuffs (or through premixtures) and water for drinking. The Applicant proposed a recommended maximum content of MSG in feedingstuffs of 25 mg/kg.
For the quantification of MSG in the feed additive the Applicant submitted an in-house validated analytical method based on reversed phase high performance liquid chromatography coupled with ultraviolet detection (HPLC-UV). While in the frame of the validation study satisfactory performance characteristics were derived, the Applicant did not present a verification study or any additional test performed by a second independent laboratory applying the above mentioned method.
For the quantification of MSG in premixtures and feedingstuffs the Applicant submitted the ring-trial validated European Union method (Commission Regulation (EC) No 152/2009) based on ion-exchange chromatography coupled to photometric detection (IEC-VIS). This method, designed only for the analysis of amino acids in premixtures and feedingstuffs, does not distinguish between the amino acids and their salts, or between different salts of the same amino acids, and it cannot differentiate between enantiomers.
The method was further ring-trial validated resulting in the EN ISO 13903:2005 method. The following performance characteristics were reported for the quantification of glutamic acid: a relative standard deviation for repeatability (RSDr) ranging from 0.9 to 2.7 % and a relative standard deviation for reproducibility (RSDR) ranging from 6.2 to 9.1 %. However, while a lowest limit of quantification (LOQ) of 30 mg/kg has been reported for the analysis of certain amino acids, a specific LOQ for glutamic acid has not been indicated. Therefore, the method does not ensure the accurate determination of MSG when added into feed at the proposed recommended maximum content (i.e. 25 mg/kg feedingstuffs).
Hence, the EURL recommends for official control the European Union method based on IEC-VIS for the quantification of MSG in premixtures only. The Applicant did not provide any experimental data to determine MSG in water. Nevertheless, as concluded in previous EURL reports on amino acids, the EURL recommends for official control the procedure based on IEC-VIS and described in the ring-trial validated European Union method (or in equivalent ring-trial validated methods e.g. VDLUFA Method 4.11.6.) to quantify MSG in in the feed additive and water.
The methods described above do not distinguish between the amino acids and their salts, or between different salts of the same amino acids, and they cannot differentiate between enantiomers. As a consequence, MSG is detected as glutamic acid.
In addition, the EURL recommends the "Monosodium L-glutamate monograph" of the Food Chemical Codex (FCC) for the identification 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, as last amended by Regulation (EU) 2015/1761) is not considered necessary.
Recommended Method
as of:
- Commission Implementing Regulation (EU) 2022/1266
For the identification of monosodium L-glutamate in the feed additive:
Food Chemical Codex ‘Monosodium L-glutamate monograph’
For the quantification of monosodium L-glutamate in the feed additive:
ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)
For the quantification of monosodium L-glutamate in premixtures:
ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F)