Amino acid L-isoleucine synthesized through fermentation using Escherichia coli strain CCTCC M 20231916.
The Henan Jinkaiyuan Biotechnology Co., Ltd. has submitted an application for the authorization of a new feed additive, L-isoleucine, produced through fermentation using Escherichia coli CCTCC M 20231916.
This feed additive falls under the category of 'nutritional additives' and 'amino acids, their salts, and analogues', as specified under Article 4 of the Regulation (EC) No 1831/2003. The authorization is also being sought according to Annex I of the same regulation.
The European Union Reference Laboratory (EURL) has considered the EN ISO 17180 method suitable for determining isoleucine in feed additives and premixtures, including the current product. This method, based on ion-exchange chromatography (IEC) with optical (visible - VIS or fluorescence - FLD) detection, is proposed for determining isoleucine in the feed additive and premixtures.
The EURL also recommends the European Union (EU) method (or equivalent EN ISO 13903 method) based on IEC-VIS for the determination of isoleucine in the feed additive, premixtures, compound feed, and water. Additionally, the EURL recommends the Food Chemical Codex (FCC) "L-isoleucine monograph" for the identification of L-isoleucine in the feed additive.
Notably, the applicant did not propose a minimum or maximum L-isoleucine content in compound feed or water. However, the feed additive contains L-isoleucine as an active substance with a minimum purity of 90 % (w/w, based on dry matter).
The feed additive is intended to be added directly to compound feed or through premixtures (or complementary feed) and water. The authorization is being sought for use in all animal species.
The EURL considers the EU method applicable for determining isoleucine in the feed additive, premixtures, compound feed, and water. The EURL also recommends the EN ISO 17180 based on IEC-VIS/FLD to determine isoleucine in the feed additive and premixtures.
No further testing or validation of the methods is considered necessary as specified by Article 10 (Commission Regulation (EC) No 378/2005, as last amended by Regulation (EU) 2015/1761). This indicates that the methods proposed by the applicant are deemed sufficient for the determination of isoleucine in the feed additive, ensuring the safety and efficacy of the product.
This development is significant as it marks a step forward in the development and approval of novel feed additives, contributing to the nutritional and health benefits for livestock and, consequently, the food chain. The decision on the authorization of the L-isoleucine feed additive is currently pending.
