The product subject of this assessment is L-threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 11473). It is intended to be used in feed and water for drinking for all animal species and categories. It was not possible to characterise the genetic modification with the information provided. Uncertainty remained on the possible presence of cells from the production strain and their recombinant DNA in the product. Therefore, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the product L-threonine, produced by fermentation with Escherichia coli CGMCC 11473 for the target species, consumers and the environment. The FEEDAP Panel has concerns on the safety of the simultaneous oral administration of threonine containing additives via water for drinking and feed. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be an irritant for skin and eyes or to be a skin sensitiser. There is a risk from the exposure by inhalation to endotoxins for persons handling the additive. 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. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union.
SummaryFollowing 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 using the genetically modified strain Escherichia coli CGMCC 11473 for all animal species.The approach followed by the FEEDAP Panel to assess the safety and the efficacy of L-threonine was in line with the principles laid down in Regulation (EC) No 429/2008 and the relevant EFSA guidance documents. The FEEDAP Panel used the data provided by the applicant together with data from other sources, such as previous risk assessments by the European Food Safety Authority (EFSA) or other expert bodies, peer-reviewed scientific papers, other scientific reports and experts' knowledge, to deliver the present output.The characterisation of the genetic modification could not be drawn from the information provided. Uncertainty remained on the possible presence of cells from the production strain and their recombinant DNA in the product. Therefore, the FEEDAP Panel could not conclude on the safety of the product L-Threonine, produced by fermentation with Escherichia coli CGMCC 11473 for the target species, consumers and the environment.The FEEDAP Panel had concerns on the safety of the simultaneous oral a...