Safety of l‐lysine monohydrochloride produced by fermentation with Escherichia coli CGMCC 7.57 for all animal species based on a dossier submitted by Feedway Europe NV

• Published in: EFSA journal Vol. 14; no. 5
• Format: Journal Article
• Language: English
• Published: 01.05.2016
• Subjects: amino acids; efficacy; l‐lysine monohydrochloride; nutritional additive; safety
• ISSN: 1831-4732; 1831-4732
• DOI: 10.2903/j.efsa.2016.4471

l‐Lysine monohydrochloride is a feed additive produced by fermentation using a genetically modified strain of Escherichia coli (CGMCC 7.57). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of the EFSA, in its opinion on the safety and efficacy of the product, could not conclude on the safety of the product for target animals, consumers, users and the environment. The European Commission asked EFSA to deliver an opinion on the safety of l‐lysine monohydrochloride as a nutritional additive for all animal species based on additional data submitted by the applicant on the characterisation of the additive. No recombinant antibiotic resistance genes are present in the production strain and therefore in the final product. The l‐lysine monohydrochloride manufactured by fermentation using E. coli CGMCC 7.57 does not raise safety concerns for the target species, consumers, users and the environment with regard to the genetic modification of the production strain. The levels of endotoxins present in the product and its dusting potential indicate no health risk for the user.