L-Valine synthesized through fermentation using Escherichia coli strain CNCM I-5911
European Union Regulation (EC) No 1831/2003 sets the rules for the authorization, use, and monitoring of feed additives in animal nutrition, including amino acids like L-valine. For such amino acids, the regulation requires the use of accurate, reliable, and validated analytical methods for determining the content of L-valine.
Official methods often rely on techniques such as high-performance liquid chromatography (HPLC) or ion-exchange chromatography with post-column derivatization to detect and quantify amino acids. These methods must be suitable for the matrix (feed additives, premixtures, compound feed, or water). There may also be requirements for method validation according to international standards such as those from AOAC International or ISO to ensure reproducibility and accuracy.
Implementing regulations under 1831/2003 or later Commission implementing acts may specify monitoring and sampling procedures, and analytical methods are often required to be submitted as part of the additive's authorization dossier. For precise, legally binding methods, the European Commission publishes specific implementing regulations or guidance documents detailing the analytical procedures and validation requirements for each category of feed additive, including amino acids.
In this context, the European Union Reference Laboratories (EURL) recommends the European Union (EU) method (or equivalent EN ISO 13903 method), based on IEC-VIS, to determine L-valine in feed additives, premixtures, compound feed, and water. For determining L-valine in compound feed, the Applicant submits the ring-trial validated EU method based on ion-exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS).
It is important to note that the EU method for determining L-valine in compound feed does not distinguish between the salts of amino acids and cannot differentiate between enantiomers. The EURL also recommends the EN ISO 17180 method based on ion-exchange chromatography coupled to optical detection (IEC-VIS/FLD) for official control of L-valine in the feed additive.
The feed additive L-valine can be mixed into premixtures, incorporated through complementary feed, or added directly to compound feed or water. The authorization for the use of L-valine in all animal species is sought under Article 4. The EURL considers the EN ISO 17180 method suitable for the determination of valine in the feed additives.
For those seeking detailed and precise information regarding the official recommended methods and validation protocols for L-valine under Regulation (EC) No 1831/2003, it is recommended to consult the European Commission’s Implementing Regulations related to feed additives, the performance and analytical method annexes accompanying Regulation 1831/2003, and guidance documents from the European Food Safety Authority (EFSA) or the European Union Reference Laboratories (EURLs) specialized on feed additives.
In the context of Euopean Union regulations, the EN ISO 17180 method based on ion-exchange chromatography coupled to optical detection (IEC-VIS/FLD) is recommended for official control of L-valine in feed additives, aligning with the regulations set by the European Commission. For precision in determining L-valine in compound feed, the Applicant may use the ring-trial validated EU method based on ion-exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS). This data serves the field of health-and-wellness by ensuring a healthy diet through the accurate measurement of feed additives like L-valine, contributing to the science of nutrition.
