Safety of L-threonine produced by fermentation using Escherichia coli CGMCC 3703, for all animal species based on a dossier submitted by GBT Europe GmbH

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Article
Panel on Additives and Products or Substances used in Animal Feed
EFSA Journal
EFSA Journal 2016;14(1):4344 [13 pp.].
doi
10.2903/j.efsa.2016.4344
Panel members at the time of adoption
Gabriele Aquilina, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino Lopez Puente, Marta Lopez-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester.
Acknowledgements

The Panel wishes to thank the members of the Working Group on amino acids including Noël Dierick, Lucio Costa and Lubomir Leng and the members of the Working Group on Genetically Modified Microorganisms, including Boet Glandorf, Lieve Herman and Sirpa Kärenlampi for the preparatory work on this scientific output. 

Contact
feedap@efsa.europa.eu
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2015-00252
Adopted
1 December 2015
Published
5 January 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

L-Threonine, technically pure, is a feed additive produced by fermentation using a genetically modified strain of Escherichia coli. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of the European Food Safety Authority (EFSA) issued an opinion on the safety and efficacy of the product, in which it could not conclude on the safety of this additive for target animals, consumer, user and the environment, due to insufficient characterisation of the genetic modification. The European Commission asked EFSA to deliver an opinion on the safety of L-Threonine, technically pure, as a nutritional additive for all animal species based on additional data submitted by the applicant. Neither the production strain nor its recombinant genes are present in the final product. Therefore, the FEEDAP Panel concludes that L-Threonine produced using E. coli CGMCC 3703 does not raise any safety concern for the target species, consumer, user and the environment with regard to the genetic modification of the production strain. The FEEDAP Panel reiterated their concerns on the safety of amino acids, including L-Threonine, for target species when administered simultaneously via water for drinking due to amino acid imbalances. As the estimated maximum exposure to endotoxins by inhalation was below the provisional occupational exposure limit, no risk from the exposure to endotoxins for people handling the additive is expected.

Summary

Following a request from the European Commission (EC), the European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the safety of L-Threonine, technically pure, produced by fermentation using the genetically modified strain Escherichia coli CGMCC 3703 for all animal species.
In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA adopted an opinion on the safety and efficacy of L-Threonine produced by fermentation with E. coli CGMCC 3703. The FEEDAP Panel could not conclude on the safety of that product for target animals, consumer, user and the environment because the genetic modification, including the presence/absence of recombinant DNA and of antibiotic resistance genes in the product, was insufficiently characterised.
The applicant provided additional information in relation to the characterisation of the production microorganism, the characterisation of the additive and its stability. The FEEDAP Panel has performed the assessment of those new data following an approach in line with the principles laid down in Regulation (EC) No 429/2008 and the relevant guidance documents.
Neither the production strain nor its recombinant genes were present in the final product. Therefore, the FEEDAP Panel concluded that L-Threonine, manufactured by fermentation with E. coli CGMCC 3703, did not raise safety concerns for the target species, consumers, users and the environment with regard to the genetic modification of the production strain.
The FEEDAP Panel reiterated their concerns on the safety of amino acids, including L-Threonine, for target species when administered simultaneously via water for drinking due to amino acid imbalances.

As the estimated maximum exposure to endotoxins by inhalation was below the provisional occupational exposure limit, no risk from the exposure to endotoxins for people handling the additive is expected.

Keywords
nutritional additive, amino acids and their salts and analogues, L-threonine, safety, genetically modified microorganisms
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Number of Pages
13