Safety of L-threonine, technically pure, produced by fermentation with Escherichia coli CGMCC 7.58 for all animal species based on a dossier submitted by Feedway Europe NV

EFSA FEEDAP Panel

Onderzoeksoutput: Bijdrage aan tijdschriftA2: Artikel in een internationaal wetenschappelijk tijdschrift met peer review, dat niet inbegrepen is in A1peer review

Uittreksel

l-Threonine, technically pure, is a feed additive produced by fermentation using a genetically modified (GM) strain of Escherichia coli (CGMCC 7.58). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of EFSA issued an opinion on the safety and efficacy of the product, which concluded that the recipient strain and its genetic modification, including the presence or absence of an antibiotic resistance gene in the product under assessment, are insufficiently characterised. Consequently, the FEEDAP Panel could not make a conclusion on the safety of the product l-threonine produced by fermentation with this recombinant strain of E. coli for target animals, consumers, users and the environment. Furthermore, the level of endotoxins present in the product and its dusting potential represent a risk for the user by inhalation. The European Commission asked EFSA to deliver an opinion on the safety of l-threonine for all animal species based on additional data submitted by the applicant on the characterisation of the additive and of the genetic modification of the production strain. No recombinant antibiotic resistance genes are present in the production strain and therefore in the final product. l-Threonine technically pure, manufactured by fermentation using E. coli CGMCC 7.58, does not raise safety concerns for the target species, consumers, users and the environment with regard to the genetic modification of the production strain. A risk from exposure to endotoxins for people handling the additive is expected. Concerns remain about possible dermal sensitisation.
Oorspronkelijke taalEngels
TijdschriftEFSA Journal
Volume14
Exemplaarnummer5
Pagina's (van-tot)4470 (11pp.)
Aantal pagina’s11
ISSN1831-4732
DOI's
PublicatiestatusGepubliceerd - 2016

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