Scientific Opinion on the safety and efficacy of L-lysine monohydrochloride produced by fermentation with Escherichia coli for all animal species based on a dossier submitted by HELM AG on behalf of Meihua Holdings Group Co. Ltd

nutritional additive, amino acids, L-lysine monohydrochloride, safety, efficacy
First published in the EFSA Journal
31. März 2015
10. März 2015
Last Updated
15. November 2016. This version replaces the previous one/s.
Scientific Opinion


The product L-lysine monohydrochloride (HCl) is produced by fermentation with a genetically modified strain of Escherichia coli. L-Lysine is an essential amino acid for all animal species. L-Lysine and its salts are widely used in the feed industry to optimise dietary protein intake. The amino acid L-lysine itself is considered safe for target animals, consumers and the environment. However, the genetic modification, including the presence or absence of antibiotic resistance genes in the product under assessment, is insufficiently characterised. Consequently, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) cannot conclude on the safety of the product L-lysine HCl produced by fermentation with this recombinant E. coli strain for target animals, consumers, users and the environment. Regardless of the assessment of the genetic modification, the FEEDAP Panel has concerns regarding the safety of the simultaneous oral administration of the product L-lysine HCl via water for drinking and feed. From the results provided, it is concluded that there are no concerns for users with respect to skin or eye irritancy, or dermal sensitisation. Nevertheless, the level of endotoxins present in the product and its dusting potential indicate an inhalation risk for the user. The concerns regarding the safety of the genetic modification may also have implications for the safety of the user. The product L-lysine HCl is an efficacious source of the supplemented amino acid, for maintaining or restoring the adequate balance of dietary amino acids, for all non-ruminant species. For the supplemental L-lysine to be as efficacious in ruminants as in non-ruminant species, it must be protected from degradation in the rumen.

Panel members at the time of adoption

Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf.
Panel on Additives and Products or Substances used in Animal Feed
EFSA Journal 2015;13(3):4052
Question Number
On request from
European Commission