Safety and efficacy of a feed additive consisting of l‐histidine monohydrochloride monohydrate produced with Escherichia coliCCTCC M 20241089 for all animal species (Anhui Huaheng Biotechnology Co., Ltd).

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Title: Safety and efficacy of a feed additive consisting of l‐histidine monohydrochloride monohydrate produced with Escherichia coliCCTCC M 20241089 for all animal species (Anhui Huaheng Biotechnology Co., Ltd).
Authors: Villa, Roberto Edoardo (AUTHOR), Azimonti, Giovanna (AUTHOR), Bonos, Eleftherios (AUTHOR), Christensen, Henrik (AUTHOR), Durjava, Mojca (AUTHOR), Dusemund, Birgit (AUTHOR), Gehring, Ronette (AUTHOR), Glandorf, Boet (AUTHOR), Kouba, Maryline (AUTHOR), López‐Alonso, Marta (AUTHOR), Marcon, Francesca (AUTHOR), Nebbia, Carlo (AUTHOR), Pechová, Alena (AUTHOR), Prieto‐Maradona, Miguel (AUTHOR), Theodoridou, Katerina (AUTHOR), Anguita, Montserrat (AUTHOR), Innocenti, Matteo Lorenzo (AUTHOR), Tarrés‐Call, Jordi (AUTHOR), Pettenati, Elisa (AUTHOR)
Source: EFSA Journal. Apr2026, Vol. 24 Issue 4, p1-11. 11p.
Subject Terms: *Animal nutrition, *Transgenic organisms, *Escherichia coli, Feed additives, Histidine, Safety, Treatment effectiveness, Amino acids in animal nutrition
Company/Entity: European Food Safety Authority
Abstract: Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐histidine monohydrochloride monohydrate produced with a genetically modified strain of Escherichia coli (CCTCC M 20241089) as a nutritional additive in feed and water for drinking for all animal species and categories. l‐Histidine monohydrochloride monohydrate manufactured by fermentation with E. coli CCTCC M 20241089 did not give rise to any safety concern regarding the genetic modifications of the production strain. No viable cells nor DNA of the production strain were detected in the final product. The use of l‐histidine monohydrochloride monohydrate produced with E. coli CCTCC M 20241089 in feed is safe for the target species when supplemented in appropriate amounts to the diet according to their nutritional needs. The FEEDAP Panel had concerns on the use of l‐histidine monohydrochloride monohydrate in water for drinking. The use of l‐histidine monohydrochloride monohydrate produced by fermentation with E. coli CCTCC M 20241089 in animal nutrition was considered safe for the consumers of products from animals receiving the additive, and for the environment. The FEEDAP Panel could not conclude on the potential of the additive to be an irritant to skin and/or eyes and to be a potential skin sensitiser. The additive was regarded as an effective source of the amino acid L‐histidine for all non‐ruminant species. To be as efficacious in ruminants as in non‐ruminants, it should be protected from ruminal degradation. [ABSTRACT FROM AUTHOR]
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Abstract:Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐histidine monohydrochloride monohydrate produced with a genetically modified strain of Escherichia coli (CCTCC M 20241089) as a nutritional additive in feed and water for drinking for all animal species and categories. l‐Histidine monohydrochloride monohydrate manufactured by fermentation with E. coli CCTCC M 20241089 did not give rise to any safety concern regarding the genetic modifications of the production strain. No viable cells nor DNA of the production strain were detected in the final product. The use of l‐histidine monohydrochloride monohydrate produced with E. coli CCTCC M 20241089 in feed is safe for the target species when supplemented in appropriate amounts to the diet according to their nutritional needs. The FEEDAP Panel had concerns on the use of l‐histidine monohydrochloride monohydrate in water for drinking. The use of l‐histidine monohydrochloride monohydrate produced by fermentation with E. coli CCTCC M 20241089 in animal nutrition was considered safe for the consumers of products from animals receiving the additive, and for the environment. The FEEDAP Panel could not conclude on the potential of the additive to be an irritant to skin and/or eyes and to be a potential skin sensitiser. The additive was regarded as an effective source of the amino acid L‐histidine for all non‐ruminant species. To be as efficacious in ruminants as in non‐ruminants, it should be protected from ruminal degradation. [ABSTRACT FROM AUTHOR]
ISSN:18314732
DOI:10.2903/j.efsa.2026.10032