Scientific Opinion on the safety and efficacy of l‐threonine produced by Escherichia coli strains NRRL B‐30843, DSM 26131, KCCM11133P or DSM 25085 for all animal species based on a dossier submitted by AMAC EEIG
2015; Wiley; Volume: 13; Issue: 9 Linguagem: Inglês
10.2903/j.efsa.2015.4236
ISSN1831-4732
AutoresEFSA Panel on Additives and Products or Substances used in Animal Feed,
Tópico(s)Agriculture Sustainability and Environmental Impact
ResumoEFSA JournalVolume 13, Issue 9 4236 OpinionOpen Access Scientific Opinion on the safety and efficacy of l-threonine produced by Escherichia coli strains NRRL B-30843, DSM 26131, KCCM11133P or DSM 25085 for all animal species based on a dossier submitted by AMAC EEIG EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Corresponding Author EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) FEEDAP@efsa.europa.eu European Food Safety Authority (EFSA), Parma, ItalyFEEDAP@efsa.europa.euSearch for more papers by this author EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Corresponding Author EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) FEEDAP@efsa.europa.eu European Food Safety Authority (EFSA), Parma, ItalyFEEDAP@efsa.europa.euSearch for more papers by this author First published: 29 September 2015 https://doi.org/10.2903/j.efsa.2015.4236Citations: 8 On request from the European Commission. Questions No EFSA-Q-2012-00113, adopted on 9 September 2015. Panel members: Gabriele Aquilina, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Maria Luisa Fernandez-Cruz, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, MarylineKouba, Secundino Lopez Puente, Marta Lopez-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Acknowledgement: The Panel wishes to thank the members of the Working Group on Amino acids and the Working Group, including Paul Brantom, Lucio Costa, Noël Dierick, Lubomir Leng and Giovanna Martelli, and the members of the WorkingGroup on Genetically Modified Microorganisms of FEEDAP, including Pier Sandro Cocconcelli, Boet Glandorf, Lieve Herman SirpaKärenlampi and Christoph Tebbe, for the preparatory work on this scientific opinion. Amended: 24 March 2020 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract This opinion concerns l-threonine as a feed additive produced by four different strains derived from Escherichia coli K-12. Three strains are genetically modified (GM): NRRL B-30843, KCCM11133P and DSM 26131. l-Threonine produced by E. coli DSM 26131 could not be assessed because of the insufficient molecular characterisation of the genetic modification, and the lack of data on both the absence of the production strain and its recombinant DNA from the final product. No safety concerns were found in the products related to the genetic modification of the other GM strains or to antibiotic resistance of the producer strains. l-Threonine products made by fermentation using E. coli strains NRRL B-30843, KCCM11133P and DSM 25085 are free of the production strain and have a high purity ( 98.8 %).l-Threonine, technically pure, produced by E. coli strains NRRL B-30843, KCCM11133P and DSM 25085 is safe for the target animals when used in appropriate amounts to supplement threonine-deficient feeds, for the consumer of animal products and for the environment. The FEEDAP Panel considers that l-threonine produced by E. colistrains NRRL B-30843, KCCM11133Por DSM 25085 is not irritant to eyes and skin, and is nota skin sensitiser. There is no risk from inhalation of l-threonine, but concerns may arise from the content of endotoxins in the products. These l-threonine products are 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. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has concerns regarding the safety of the simultaneous oral administration of l-threonine via water for drinking and feed. References Bauer AP, Dieckmann SM, Ludwig W and Schleifer KH, 2007. Rapid identification of Escherichia coli safety and laboratory strain lineages based on Multiplex-PCR. Federation of European Microbiological Societies Microbiology Letters, 269, 36– 40. Blattner FR, Plunkett G 3rd, Bloch CA, Perna NT, Burland V, Riley M, Collado-Vides J, Glasner JD, Rode CK, Mayhew GF, Gregor J, Davis NW, Kirkpatrick HA, Goeden MA, Rose DJ, Mau B and Shao Y, 1997. The complete genome sequence of Escherichia coliK-12. Science, 277, 1453– 1462. Cort N, Fredriksson G, Kindahl H, Edqvist LE and Rylander R, 1990. A clinical and endocrine study on the effect of orally administered bacterial endotoxin in adult pigs and goats. Journal of Veterinary Medicine Series A, 37, 130– 137. EFSA (European Food Safety Authority), 2008a. Amino acids from chemical group 34. Flavouring Group Evaluation 26, Revision 1. Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with Food (AFC). EFSA Journal, 790, 1– 51. EFSA (European Food Safety Authority), 2008b. Technical guidance on microbial studies. Prepared by the Panel on Additives and Products or Substances used in Animal Feed. The EFSA Journal2008, 836, 1– 3. EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards), 2013. Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2013 update). EFSA Journal 2013; 11(11):3449, 105pp. https://doi.org/10.2903/j.efsa.2013.3449 EFSA FEEDAP Panel (Panel on Additives and Products or Substances used in Animal Feed), 2010a. Scientific Opinion on Flavouring Group Evaluation 26: Amino acids from chemical group 34. The EFSA Journal (2006) 373, 1– 48. EFSA FEEDAP Panel (Panel on Additives and Products or Substances used in Animal Feed), 2010b. Scientific Opinion on the use of feed additives authorised/applied for use in feed when supplied via water. EFSA Journal 2010; 8(12):1956, 9pp. https://doi.org/10.2903/j.efsa.2010.1956 EFSA FEEDAP Panel (Panel on Additives and Products or Substances used in Animal Feed), 2012. Guidance on studies concerning the safety of use of the additive for users/workers. EFSA Journal 2012; 10(1):2539, 5pp. https://doi.org/10.2903/j.efsa.2012.2539 EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2013. Scientific opinion on the safety and efficacy of l-threonine produced by Escherichia coli (FERM BP-10942) for all animal species based on a dossier submitted by Ajinomoto Eurolysine SAS. EFSA Journal 2013; 11(7):3319, 2pp. https://doi.org/10.2903/j.efsa.2013.3319 EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2014a. Scientific Opinion on the safety and efficacy of l-threonine (ThreAMINO®) produced by Escherichia coliK-12 (DSM 25086) for all animal species and categories based on a dossier by Evonik Industries A.G. EFSA Journal 2014; 12(2):3564, 2pp. https://doi.org/10.2903/j.efsa.2014.3564 EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2014b. Scientific Opinion on the safety and efficacy of L-threonine produced by Escherichia coli for all animal species, based on a dossier submitted by HELM AG on behalf of Global Bio-Chem Technology. EFSA Journal 2014; 12(5):3674, 3pp. https://doi.org/10.2903/j.efsa.2014.3674 EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2014c. Scientific Opinion on the safety and efficacy of L-threonine produced by Escherichia coli (CGMCC 7.29) for all animal species based on a dossier submitted by HELM AG on behalf of Star Lake Bioscience Co. EFSA Journal 2014; 12(6):3726, 14pp. https://doi.org/10.2903/j.efsa.2014.3726 EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2014d. Scientific Opinion on the safety and efficacy of L-threonine produced by Escherichia coli (FERM BP-11383) for all animal species, based on a dossier submitted by Ajinomoto Eurolysine S.A.S. EFSA Journal 2014; 12(10):3825, 14pp. https://doi.org/10.2903/j.efsa.2014.3825 EFSA GMO Panel (Panel on Genetically Modified Organisms), 2011. Scientific Opinion on Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use. EFSA Journal 2011; 9(6):2193, 54pp.https://doi.org/10.2903/j.efsa.2011.2193 EPA (US Environmental Protection Agency), 1997. Escherichia coliK-12 derivatives final risk assessment. Available online: http://epa.gov/biotech_rule/pubs/fra/fra004.htm Gao B, Wang Y and Tsan MF, 2006. The heat sensitivity of cytokine-inducing effect of lipopolysaccharide. Journal of Leukocyte Biology, 80, 359– 366. Gorbach SL, 1978. Risk assessment of recombinant DNA experimentation with Escherichia coli K12. Proceedings from a workshop at Falmouth, Massachusetts. Journal of Infectious Diseases, 137, 613– 714. Health Council of the Netherlands, 2010. Endotoxins. Health-based recommended occupational exposure limit. Publication no 2010/04OSH, 100 pp. HSE (Health and Safety Executive), 2013. Occupational hygiene implications of processing waste at materials recycling facilities (MRFs). RR977 Research Report, HSE, London, UK, 41 pp. Kaper JB, Natro JP and Mobley HLT, 2004. Pathogenic Escherichia coli. Nature Reviews Microbiology, 2, 123– 140. Luchi M and Morrison DC, 2000. Comparable endotoxic properties of lipopolysaccharides are manifest in diverse clinical isolates of gram-negative bacteria. Infection and Immunity, 68, 1899– 1904. Nataro JP and Kaper JB, 1998. Diarrheagenic Escherichia coli. Clinical Microbiology Reviews, 11, 142– 201. Rylander R, 1999. Health effects among workers in sewage treatment plants. Occupational Environmental Medicine, 56, 354– 357. Svensson M, Han L, Silfersparre G, Haggstrom L and Enfors SO, 2005. Control of endotoxin release in Escherichia coli feed-batch cultures. Bioprocess and Biosystems Engineering, 27, 91– 97. Thorn J, 2001. The inflammatory response in humans after inhalation of bacterial endotoxin: a review. Inflammatory Response, 50, 254– 261. Citing Literature Volume13, Issue9September 20154236 ReferencesRelatedInformation
Referência(s)