Safety and efficacy of a feed additive consisting of l-tryptophan produced using Corynebacterium glutamicumKCCM 80346 for all animal species (CJ Europe GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of L-tryptophan produced by fermentation using the genetically modified strain of Corynebacterium glutamicum, KCCM 80346, as a nutritional additive in feed for all animal species and categories. In the manufacturing process used to obtain the product under assessment, the cells from the production strain are inactivated but not removed from the final product. The FEEDAP Panel concluded that the additive does not give rise to any safety concern regarding the genetic modification of the strain. DNA from the strain is present in the final product, but its presence does not raise any safety issue since the strain does not harbour any gene of concern. No viable cells of the strain were detected in the final product. The use of l-tryptophan produced using C. glutamicum KCCM 80346 in feed is considered safe for non-ruminant species. There may be a risk for an increased production of toxic metabolites when unprotected tryptophan is used in ruminants. The use of the additive in animal nutrition is considered safe for the consumers of products from animals receiving the additive, and to the environment. With regard to the safety for the user, the additive is not irritant to the eyes or skin, but it should be considered a skin and respiratory sensitiser. Exposure by inhalation and dermal routes is considered a risk. The additive l-tryptophan produced using C. glutamicum KCCM 80346 is regarded as an effective source of the amino acid l-tryptophan for all non-ruminant species. To be as efficacious in ruminants as in non-ruminants, it should be protected from ruminal degradation.