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.

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 / G. Aquilina, G. Azimonti, V. Bampidis, M. de Lourdes Bastos, G. Bories, A. Chesson, P. Sandro Cocconcelli, G. Flachowsky, J. Gropp, B. Kolar, M. Kouba, S. Lo pez Puente, M. Lo pez-Alonso, A. Mantovani, B. Mayo, F. Ramos, G. Rychen, M. Saarela, R.E. Villa, R. John Wallace, P. Wester. - In: EFSA JOURNAL. - ISSN 1831-4732. - 14:5(2016), pp. UNSP 4471.1-UNSP 4471.9. [10.2903/j.efsa.2016.4471]

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

R.E. Villa;
2016

Abstract

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.
nutritional additive, amino acids, L-lysine monohydrochloride, safety, efficacy
Settore VET/07 - Farmacologia e Tossicologia Veterinaria
2016
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/561314
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