Assessment on the Safety and Efficacy of a Feed Additive Consisting of L-isoleucine Produced by <i>Corynebacterium Glutamicum</i> KCCM 80185 for All Animal Species (CJ Europe GmbH) (RP2212)

An application was submitted to the Food Standards Agency and Food Standards Scotland in April 2024 from CJ Europe GmbH (“the applicant”) for the new authorisation of an additive consisting of L-isoleucine produced by Corynebacterium glutamicum KCCM 80185, under the category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’, for all animal species. In 2021, the European Food Safety Authority (EFSA) published a scientific opinion on the safety and efficacy of a feed additive consisting of L-isoleucine produced by Corynebacterium glutamicum KCCM 80185. The FEEDAP Panel concluded that the genetically modified production strain does not carry acquired antimicrobial resistance genes and no viable cells of the production strain were detected in the final additive. The presence of recombinant DNA from the production strain in the final additive could not be excluded. However, safety concerns regarding the potential presence of recombinant DNA from the production strain in the additive were not raised as no sequences of concern remain in the final production strain. Further, the FEEDAP Panel concluded that the additive is safe for the target species, the consumer and the environment under the proposed conditions of use. However, concern was raised regarding the simultaneous use of L-isoleucine in drinking water and feed due to the risk of nutritional imbalances, and hygienic reasons. Furthermore, the FEEDAP Panel concluded that L-isoleucine produced by C. glutamicum KCCM 80185 is considered non-toxic by inhalation, is not an irritant to the eyes or skin and is not a skin sensitiser. However, exposure to dust may be a risk for the user due to the high dusting potential of the additive. The additive is considered an efficacious source of the essential amino acid L-isoleucine for non-ruminant animal species. Protection against degradation in the rumen is required for the additive to be as efficacious in ruminants as in non-ruminant species. Following the 2021 scientific opinion, EFSA published a scientific opinion on the presence of DNA in the feed additive consisting of L-isoleucine produced by Corynebacterium glutamicum KCCM 80185 in 2023. The FEEDAP Panel assessed supplementary data to exclude the presence of recombinant DNA from the production organism in the additive and concluded that DNA of the production strain C. glutamicum KCCM 80185 was not detected in the additive. FSA/FSS has reviewed the authorisation application, supporting documentation, and other regulators’ risk assessments, most notably the EFSA risk assessment opinion, and considers that sufficient evidence has been demonstrated to conclude without the need for further questions or risk assessment.