EFSA's Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has concluded that l-leucine produced with a genetically modified strain of Corynebacterium glutamicum (KCCM 80421) is safe for all animal species when used as a nutritional or sensory feed additive, but raised concerns about its use in drinking water. The scientific opinion, adopted on 1 July 2026 and published on 28 July 2026, responds to a European Commission request for authorisation of the additive, marketed by CJ Europe GmbH. The panel found no safety concerns from the genetic modification, as no viable cells or DNA of the production strain were detected in the final product. The additive is considered safe for target animals, consumers, and the environment when used appropriately in feed. However, the panel expressed concerns regarding the use of l-leucine in water for drinking, without elaborating on specific risks. Regarding user safety, the additive is not irritant to skin or eyes and is not a skin sensitiser. The panel confirmed its efficacy as a source of l-leucine for all non-ruminant species, noting that for ruminants it must be protected from ruminal degradation to be effective. It also deemed l-leucine efficacious as a flavouring compound. The additive has not been previously authorised in the EU, though l-leucine from other production strains is already approved. The application was submitted on 10 December 2024 and validated on 14 April 2025. The opinion will inform the Commission's decision on whether to grant market authorisation under Regulation (EC) No 1831/2003.
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