Scientific Opinion on the safety and efficacy of L-isoleucine for all animal species

Following a request from the European Commission, the European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the efficacy and safety of the product L-isoleucine for all animal species. The product L-isoleucine contains on a dry matter basis not less than 93.4% L-isoleucine, about 5% other amino acids and less than 1% unidentified impurities. It is produced by a genetically modified Escherichia coli K12 strain. The introduced genes do not trigger any safety concerns. The final product does not contain any cultivable production organism and the level of the recombinant DNA is below the limit of detection of the method used. Based on the available knowledge and studies in piglets, it is concluded that L-isoleucine is a source of available isoleucine and is safe for all animal species, when added to diets to cover the animal requirement. L-isoleucine contains less than 1% unidentified impurities. Considering also data from additional toxicity studies supporting its safety and the fact that the consumer will not be exposed to additional isoleucine, it is concluded that no safety concerns for the consumer would result from the use of L-isoleucine as feed additive. The product L-isoleucine is considered to be non irritant to skin and eyes and not to be a dermal sensitiser. The only detectable risk for the user could be derived from the dustiness of the product, but on the basis of an acute inhalation toxicity study, this is expected to be minor. L-isoleucine is a physiological amino acid and a natural component of animals and plants whose use in animal nutrition would not lead to any localised increase in concentration in the environment. It is concluded that the use of the product as a feed additive does not present a foreseeable risk to the environment.