EU reviews L-histidine monohydrochloride as a new animal feed additive

A request has been submitted for the authorisation of L-histidine monohydrochloride monohydrate as a feed additive. The product, made through fermentation with Escherichia coli CCTCC M 20241089, is intended for all animal species. The application covers its use in compound feed, premixtures, and drinking water.

The applicant has proposed two methods for analysing histidine levels. For the feed additive and premixtures, the EN ISO 17180 standard is suggested. Meanwhile, the EU method is recommended for compound feed and water.

The European Union Reference Laboratory (EURL) advises using the *L-histidine monohydrochloride monograph* from the Food Chemical Codex (FCC) to confirm the additive’s identity. Testing shows repeatability results (RSD) between 2.4% and 7.0%, while reproducibility ranges from 12.9% to 23.3% for histidine in animal feed. The additive itself must contain at least 98.0% (w/w, dry matter) L-histidine monohydrochloride monohydrate. Additionally, a method based on HPLC-UV has been validated to detect histamine, a possible impurity in such products.

The authorisation request follows EU regulations under Article 4(1). If approved, the additive could be incorporated directly into feed, premixtures, or drinking water. The proposed testing methods aim to ensure accuracy in measuring both histidine content and potential impurities.