Safety and efficacy of l-threonine produced by fermentation with Corynebacterium glutamicum ■■■■■ for all animal species
- PMID: 32626239
- PMCID: PMC7009145
- DOI: 10.2903/j.efsa.2019.5603
Safety and efficacy of l-threonine produced by fermentation with Corynebacterium glutamicum ■■■■■ for all animal species
Abstract
Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l-threonine produced by fermentation with Corynebacterium glutamicum ■■■■■ when used as nutritional additive in feed and water for drinking for all animal species and categories. The product under assessment is l-threonine produced by fermentation with a genetically modified strain of C. glutamicum (■■■■■). The production strain and its recombinant DNA were not detected in the additive. The product l-threonine, manufactured by fermentation with C. glutamicum, ■■■■■ does not give rise to any safety concern with regard to the production strain. l-Threonine produced using C. glutamicum ■■■■■ is considered safe for the target species. The FEEDAP Panel has concerns regarding the safety of the simultaneous oral administration of l-threonine via water for drinking and feed. l-Threonine produced using C. glutamicum ■■■■■ is safe for the consumer. The additive is not a skin or eye irritant and is not a skin sensitiser. Although the workers can be exposed by inhalation, the results of an acute inhalation study showed that risk of adverse effects by inhalation is low. l-Threonine produced using C. glutamicum ■■■■■ is safe for the environment. The product under assessment is considered an efficacious source of the amino acid l-threonine for all animal species. For l-threonine to be as efficacious in ruminants as in non-ruminant species, it requires protection against degradation in the rumen.
Keywords: amino acid; efficacy; genetically modified microorganism; l‐threonine; nutritional additive; safety.
© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
References
-
- EFSA (European Food Safety Authority), 2007. Opinion of the Scientific Committee on a request from EFSA on the introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA. EFSA Journal 2007;5(12):587, 16 pp.
-
- EFSA (European Food Safety Authority), 2008. Technical Guidance of the Scientific Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) for assessing the safety of feed additives for the environment. EFSA Journal 2008;6(10):842, 28 pp. 10.2903/j.efsa.2008.842 - DOI
-
- EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards), Koutsoumanis K, Allende A, Alvarez‐Ordonez A, Bolton D, Bover‐Cid S, Chemaly M, Davies R, Hilbert F, Lindqvist R, Nauta M, Peixe L, Ru G, Simmons M, Skandamis P, Suffredini E, Cocconcelli PS, Fernandez Escamez PS, Maradona MP, Querol A, Suarez JE, Sundh I, Vlak J, Barizzone F, Correia S and Herman L, 2019. Statement on the update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 9: suitability of taxonomic units notified to EFSA until September 2019. EFSA Journal 2019;17(1):5555, 46 pp. 10.2903/j.efsa.2019.5555 - DOI - PMC - PubMed
-
- EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances Used in Animal Feed), 2010. Scientific Opinion on the use of feed additives authorised/applied for use in feed when supplied via water. EFSA Journal 2010;8(12):1956, 9 pp. 10.2903/j.efsa.2010.1956 - DOI
-
- EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2012a. Guidance for the preparation of dossiers for nutritional additives. EFSA Journal 2012;10(1):2535, 14 pp. 10.2903/j.efsa.2012.2535 - DOI