Safety of l‐lysine sulfate produced by fermentation with Escherichia coli CGMCC 3705 for all animal species

Abstract In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of l‐lysine sulfate produced by fermentation with Escherichia coli CGMCC 3705, when used as a nutritional additive for all animal species. The Panel concluded that a maximum supplementation of complete feed up to 1% l‐lysine sulfate was considered safe for all animal species; its use in animal feed does not pose a risk to the consumer or the environment; l‐Lysine sulfate was not considered a skin or eye irritant or a skin sensitiser, but should be considered a hazard by inhalation. The applicant originally proposed a specification of minimum 55% lysine. However, based on the data provided in the technical dossier, the FEEDAP Panel recommended that the additive should be specified to a l‐lysine content ≥ 65%. The applicant seeks authorisation for l‐lysine sulfate with a minimum content of 55% l‐lysine. The Commission gave the applicant the possibility of submitting complementary information to complete its assessment. The additional data on the characterisation of the additive containing ≥ 55% l‐lysine showed that > 99% of the product is comprised of known constituents, which do not give rise to safety concerns at the concentrations present. Therefore, the FEEDAP Panel considers that the conclusions of the previous opinion are applicable to the product l‐lysine produced with E. coli CGMCC 3705 containing ≥ 55% l‐lysine. Specifically, the FEEDAP Panel concludes that a maximum supplementation of complete feed up to 1% l‐lysine sulfate is considered safe for all animal species; that the use in animal feed does not pose a risk to the consumer or the environment; and that l‐Lysine sulfate is not considered a skin or eye irritant or a skin sensitiser, but should be considered a hazard by inhalation.