Scientific opinion on the safety and efficacy of L-threonine produced by Escherichia coli (FERM BP-10942) for all animal species based on a dossier submitted by Ajinomoto Eurolysine SAS

The product L-threonine, technically pure, is an essential amino acid that contains by specification ≥ 98 % L-threonine. It is produced by a genetically modified Escherichia coli strain. Neither the production strain nor its recombinant DNA was detectable in the final product. The final product does not raise safety concerns with regard to the genetic modification. L-Threonine, technically pure, is considered safe for the target animals when used to meet the requirements. The toxicological studies, including mutagenicity tests, performed with the additive or other sources of L-threonine did not reveal any toxic effect. Since the composition of tissues and products of animal origin will not be changed by the use of L-threonine in animal nutrition, and considering the high purity of the product under assessment, no risks are expected for the consumer from the use of L-threonine, technically pure, as a feed additive. The product is not irritating to the skin or eyes and is not likely to be a skin sensitiser. Although there is a potential for user exposure by inhalation, there is no evidence of acute toxicity by the inhalation route. The use of the product as a feed additive does not represent a risk to the environment. L-Threonine, technically pure, is considered as an efficacious source of L-threonine for all animal species. Response in ruminants requires some degree of protection of threonine from ruminal degradation.