E. coli derived additive gets EU approval
The approval was published in the Official Journal of the EU this week.
L-threonine is an essential amino acid for all animal species. It is widey used in the feed industry to optimise dietary protein intake.
In a March 2015 assessment, the FEEDAP panel of the European Food Safety Authority (EFSA) said it could not conclude 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.
The reason, said the panel, was that the recipient strain and its genetic modification, including the presence or absence of an antibiotic resistance gene in the production strain, and therefore in the product, were insufficiently characterised.
Antibiotic resistance genes
However, the Commission gave the possibility to the applicant to submit complementary information to EFSA in the interests of a further review.
On EFSA’s receipt of that additional data, the Commission asked it to deliver a new opinion on the safety of the L-threonine additive.
EFSA concluded in May this year that the production strain is adequately identified as an E. coli K-12 derivative.
It said E. coli K-12 is considered safe.
The applicant, explained the said the Parma based EU risk assessor, provided evidence that the production strain does not carry the antibiotic resistance genes transiently used during the genetic modification.
And absence in the product of recombinant DNA corresponding to the inserted sequences had been previously shown, continued EFSA.
Therefore, L-threonine, manufactured by fermentation with E. coli CGMCC 7.58, does not raise any safety concern for the target species, the consumer, the user and the environment with regard to the genetic modification of the production strain, said the Authority.
EFSA said for the supplemental L-threonine to be fully efficacious in ruminants, it needs to be protected against degradation in the rumen.
