Scientific Opinion on the safety and efficacy of L‐tryptophan, technically pure, produced by Escherichia coli strains DSM 25084, KCCM 11132P or SARI12091203 for all animal species based on a dossier submitted by AMAC EEIG

Abstract

The product L‐tryptophan is a nutritional feed additive produced by fermentation using one of three strains of Escherichia coli. L‐Tryptophan produced by E. coli SARI12091203 could not be assessed because the data submitted did not permit the identity and safety of the strain, and the purity of the additive, to be determined. The EFSA Panel on Additives and Products or Substance used in Animal Feed (FEEDAP) could not conclude on the safety of this product for target animals, for consumers, users and the environment. Strain KCCM 11132P is genetically modified, but its product gives no cause for concern on GM grounds because no recombinant DNA or live bacteria were detected. l‐Tryptophan produced by E. coli KCCM 11132P or E. coli DSM 25084 is safe for non‐ruminant target species when supplemented to diets in appropriate amounts, but should not be given to ruminants in an unprotected form because of the formation of skatole (3‐methylindole) during ruminal fermentation. l‐Tryptophan produced by E. coli KCCM 11132P or E. coli DSM 25084 contains low concentrations of 1,1′‐ethylidene‐bis‐L‐tryptophan and 1‐methyl‐1,2,3,4‐tetrahydro‐beta‐carboline‐3‐carboxylic acid and is safe for the consumer of animal products. The level of endotoxins present in the products of E. coli KCCM 11132P or E. coli DSM 25084 and its possible dusting potential indicate an inhalation risk for the user. In the absence of data on the potential for dermal sensitisation it is concluded that such potential may exist. No other concerns for user safety (inhalation toxicity, skin and eyes irritation) regarding the L‐tryptophan produced by E. coli DSM 25084 were identified. The use of the product L‐tryptophan produced by E. coli KCCM 11132P or E. coli DSM 25084 in animal nutrition does not pose a risk to the environment. The products under application are efficacious sources of the amino acid L‐tryptophan for animal nutrition.

Safety and efficacy of l‐tryptophan produced by fermentation with Escherichia coli KCCM 80152 for all animal species

“…The applicant submitted a study on the shelf-life of the additive and a study on the stability of the additive in water for drinking performed with the additive under assessment. The rest of the stability studies (shelf-life at room temperature, stability in premixtures and in feedingstuffs and capacity to distribute homogeneously in premixtures and in pelleted feed) were performed with L-tryptophan produced by different E. coli strains (KCCM 80135 or KCCM 11132P) from the same producer (EFSA FEEDAP Panel, 2015b, 2019c. 36 As the production strains share a common lineage (E. coli K12 derivatives), the manufacturing process is the same and the product characteristics are very similar, the FEEDAP Panel considers that the stability and homogeneity studies performed with L-tryptophan of the other two production strains are indicative of the stability of the product under assessment.…”

Safety of l‐tryptophan technically pure, produced by fermentation with Escherichia coli DSM 25084, KCCM 11132P and SARI12091203 for all animal species based on a dossier submitted by FEFANA Asbl

“…L-Tryptophan produced by Escherichia coli KCCM 11132P 5 L-Tryptophan produced by E. coli KCCM 11132P has been characterised in a previous scientific opinion (EFSA FEEDAP Panel, 2015).…”

“…In 2015, the FEEDAP Panel issued an opinion on the safety and efficacy of L-tryptophan produced by E. coli strains DSM 25084 or KCCM 11132P (EFSA FEEDAP Panel, 2015). The Panel concluded that the additives produced by E. coli strains DSM 25084 and KCCM 11132P do not give rise to safety concerns with regard to the genetic modifications of the production strain and that they are safe for non-ruminant target species when supplemented to diets in nutritionally appropriate amount, but should not be given to ruminants in an unprotected form because of the formation of skatole (3-methylindole) during ruminal fermentation.…”

“…L-Tryptophan produced by E. coli DSM 25084 has been characterised in a previous scientific opinion ( EFSA FEEDAP Panel, 2015).…”

“…Safety for the user 3.2.2.1. Effects on the respiratory system Although a previous assessment was performed in January 2015 (EFSA FEEDAP Panel, 2015), the technological change in the manufacturing process makes it necessary to reassess the relevance of the bacterial endotoxin activities found in the final product for the user.…”