Following a request from the European Commission, the European Food Safety Authority was asked to deliver a scientific opinion on L-lysine sulphate produced by microbial fermentation using a genetically modified strain of Escherichia coli (CGMC 3705).
L-Lysine is an essential amino acid for all animal species. L-Lysine sulphate is widely used in the feed industry to optimise the amino acid profile of diets in order to improve animal performance.
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.
The FEEDAP Panel made some recommendations concerning the description of the additive, its specification and its proper use in animal nutrition.
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