L-threonine produced by fermentation with Corynebacterium glutamicum KCCM 80367

In the current application an authorisation is sought under Article 4(1) for L-threonine produced by fermentation with Corynebacterium glutamicum KCCM 80367, 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 L-threonine as an active substance at a minimum of 75 % (w/w).
L-threonine is intended to be mixed either in premixtures or added directly into compound feed. However, the Applicant did not propose a minimum or maximum L-threonine content in compound feed.
For the determination of threonine in the feed additive and premixtures the Applicant submitted the ring-trial validated method EN ISO 17180:2013 based on ion-exchange chromatography coupled to post-column derivatisation and optical (visible or fluorescence) detection (IEC-VIS/FLD). The method is dedicated for the determination of free lysine, methionine and threonine in commercial amino acid products and premixtures containing more than about 10 % of the amino acid. The following performance characteristics were reported for the determination of threonine: a relative standard deviation for repeatability (RSDr) ranging from 0.7 to 1.4 % and a relative standard deviation for reproducibility (RSDR) ranging from 1.9 to 2.3 %.
Based on the performance characteristics available, the EURL recommends for official control the EN ISO 17180:2013 method based on IEC-VIS/FLD for the determination of threonine in the feed additive and premixtures.
For the determination of threonine in compound feed the Applicant submitted the ring-trial validated European Union (EU) method (Commission Regulation (EC) No 152/2009). The method is based on ion-exchange chromatography coupled to optical detection (IEC-VIS) and is dedicated for the analysis of free and total amino acids in premixtures containing less than 10 % of the amino acid and compound feed. The EU method was initially ring-trial validated using four different matrices and further validated in the second ring-trial, resulting in the EN ISO 13903:2005 method. The following combined performance characteristics were reported for the determination of total threonine in animal feedingstuffs: RSDr ranging from 1.9 to 4.1 % and RSDR ranging from 3.8 to 11.7 %. Furthermore, limits of quantification (LOQ) of 0.03 and 0.2 g/kg compound feed were reported for free and total threonine, respectively. Based on the performance characteristics available, the EURL recommends for official control the ring-trial validated European Union (EU) method, based on IEC-VIS to determine threonine in premixtures and compound feed.
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.