Scientific Opinion on the safety and efficacy of L‐lysine sulphate produced by fermentation with Escherichia coli CGMCC 3705 for all animal species
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Abstract The product L‐lysine sulphate is a feed additive produced by fermentation with a genetically modified strain of Escherichia coli K‐12. Neither the production strain nor its recombinant DNA was detected in the final product. Therefore, the product L‐lysine sulphate, feed grade, manufactured by fermentation with E. coli CGMCC 3705, does not give rise to any safety concern with regard to the genetic modification of the production strain. Owing to potential adverse effects of the intrinsic high sulphate content in the product under application, a maximum supplementation of complete feed up to 1 % L‐lysine sulphate is considered safe for all animal species and categories. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the use in animal feed of L‐lysine sulphate produced by E. coli CGMCC 3705 does not pose a risk to the consumer or the environment. L‐Lysine sulphate is not considered a skin or eye irritant or a skin sensitiser. The product should be considered a hazard by inhalation. The L‐lysine sulphate under assessment is regarded as an efficacious source of the amino acid L‐lysine for all animal species. For supplemental L‐lysine sulphate to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen.
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