TY - JOUR

T1 - Safety and efficacy of a feed additive consisting of l-lysine sulfate produced by Escherichia coli CGMCC 7.398 for all animal species (Kempex Holland B.V.)

AU - Bampidis, Vasileios

AU - Azimonti, Giovanna

AU - Bastos, Maria de Lourdes

AU - Christensen, Henrik

AU - Dusemund, Birgit

AU - Fašmon Durjava, Mojca

AU - Kouba, Maryline

AU - López-Alonso, Marta

AU - López Puente, Secundino

AU - Marcon, Francesca

AU - Mayo, Baltasar

AU - Pechová, Alena

AU - Petkova, Mariana

AU - Ramos, Fernando

AU - Sanz, Yolanda

AU - Villa, Roberto Edoardo

AU - Woutersen, Ruud

AU - Herman, Lieve

AU - Galobart, Jaume

AU - Pettenati, Elisa

AU - Tarrés-Call, Jordi

AU - EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

N1 - Publisher Copyright: © 2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.

PY - 2022

Y1 - 2022

N2 - Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l-lysine sulfate produced by the genetically modified strain Escherichia coli CGMCC 7.398 as a nutritional feed additive for all animal species. Neither the production strain nor its recombinant DNA were detected in the final product. The additive does not pose any safety concerns associated with the production strain. The additive under assessment is considered safe for the target species. When using l-lysine sulfate, the background sulfur/sulfate content in the compound feed should be taken into account. l-lysine sulfate produced by E. coli CGMCC 7.398 is safe for the consumers and for the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive under assessment to be irritant to skin or eyes, or on its potential to be a dermal sensitiser. The endotoxin activity of the additive represents a risk by inhalation for users handling the additive. The additive l-lysine sulfate is considered as an efficacious source of the essential amino acid l-lysine for non-ruminant animal species. For the supplemental l-lysine to be as efficacious in ruminants as it is in non-ruminant species, this would require protection against degradation in the rumen.

AB - Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l-lysine sulfate produced by the genetically modified strain Escherichia coli CGMCC 7.398 as a nutritional feed additive for all animal species. Neither the production strain nor its recombinant DNA were detected in the final product. The additive does not pose any safety concerns associated with the production strain. The additive under assessment is considered safe for the target species. When using l-lysine sulfate, the background sulfur/sulfate content in the compound feed should be taken into account. l-lysine sulfate produced by E. coli CGMCC 7.398 is safe for the consumers and for the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive under assessment to be irritant to skin or eyes, or on its potential to be a dermal sensitiser. The endotoxin activity of the additive represents a risk by inhalation for users handling the additive. The additive l-lysine sulfate is considered as an efficacious source of the essential amino acid l-lysine for non-ruminant animal species. For the supplemental l-lysine to be as efficacious in ruminants as it is in non-ruminant species, this would require protection against degradation in the rumen.

KW - amino acid

KW - efficacy

KW - Escherichia coli CGMCC 7.398

KW - Lysine sulfate

KW - nutritional additive

KW - safety

U2 - 10.2903/j.efsa.2022.7246

DO - 10.2903/j.efsa.2022.7246

M3 - Journal article

C2 - 35475160

AN - SCOPUS:85129393770

VL - 20

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 4

M1 - e07246

ER -