EU Review Underway for L-Histidine Feed Additive Approval Across All Livestock

An application has been submitted for the authorisation of L-histidine monohydrochloride monohydrate as a feed additive. The product, derived from Escherichia coli CCTCC M 20241089, is intended for all animal species. It would be used directly in compound feed, through premixtures, or added to drinking water.

The additive contains at least 98.0 % L-histidine monohydrochloride monohydrate by dry weight.

The Applicant proposed the EN ISO 17180 method for measuring histidine levels in the feed additive and premixtures. For compound feed and water, the EU method was recommended instead. Official controls would also rely on the EU method to assess histidine in all relevant matrices, including the additive itself, premixtures, compound feed, and drinking water.

To identify the substance, the European Union Reference Laboratory (EURL) suggested using the *L-histidine monohydrochloride monohydrate* monograph from the Food Chemical Codex (FCC). Meanwhile, a separate HPLC-UV-based method was deemed valid for detecting histamine, a potential impurity in L-histidine products. Repeatability tests for histidine determination in animal feed showed reported standard deviations (RSD) between 2.4 % and 7.0 %. Reproducibility, however, varied more widely, with RSD values ranging from 12.9 % to 23.3 %.

The authorisation request covers L-histidine monohydrochloride monohydrate for use across all animal species. If approved, the additive would be incorporated into feed or water under regulated testing methods. The proposed analytical approaches aim to ensure accurate measurement of both the additive and any impurities.