Safety and efficacy of l-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli (NITE BP-02526) for all animal species
At the request of the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was tasked with providing a scientific opinion on l-histidine monohydrochloride monohydrate, produced through fermentation using *Escherichia coli* (NITE BP-02526), when used as a nutritional additive or feed flavoring agent in animal feed and drinking water across all animal species. The product being evaluated is l-histidine HCl H2O, obtained via fermentation with a genetically modified strain of *E. coli* (NITE BP-02526). Neither the production strain nor its recombinant DNA were found in the final product. There are no safety concerns regarding the production strain in l-histidine HCl H2O. When used to supplement animal diets in appropriate quantities, l-histidine HCl H2O is safe for the target species. It is also safe at the proposed use level of 25 mg/kg as a flavoring compound for all animal species. Furthermore, its use in animal nutrition presents no safety risks for consumers of animal products. The additive is not irritating to skin or eyes and does not act as a skin sensitizer, although there is a potential risk for handlers due to exposure to endotoxins through inhalation. Using l-histidine as a feed additive poses no environmental risk. The additive l-histidine HCl H2O is considered an effective source of the amino acid l-histidine when used as a nutritional additive. To be equally effective in ruminants as in non-ruminant species, the supplemental l-histidine must be protected from ruminal degradation. It is also deemed effective as a feed flavoring agent under the proposed conditions of use.