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Scientific Opinion on the safety and efficacy of L-valine (L-valine, feed grade) produced by Escherichia coli NITE BP-01755 for all animal species based on a dossier submitted by Ajinomoto Eurolysine S.A.S.

The product L-valine is a feed additive produced by fermentation with a genetically modified strain of Escherichia coli (NITE BP-01755). Neither the production strain E. coli NITE BP-01755 nor its recombinant DNA was detected in the final product. The product does not give rise to any safety concern associated with the genetic modification of the production strain. L-Valine, feed grade, is safe for all target species when used to meet the animals’ nutritional requirements. As the composition of tissues and products of animal origin will not be changed by the use of the product in animal nutrition, and considering its high purity, no risks are expected for the consumer from the use of the product as a feed additive. L-Valine produced by E. coli NITE BP-01755 is not considered irritating to the skin or eyes and is not likely to be a skin sensitiser. Although there is a potential for user exposure by inhalation, acute toxicity by this route is not expected. Since the estimated total exposure to endotoxins by inhalation is below the provisional occupational exposure limits, no risk from the exposure to endotoxins for people handling the additive is expected. The amino acid L-valine is a natural component of the proteins of living organisms. Therefore, the use of the product does not pose a risk to the environment. The product is considered an efficacious source of the amino acid L-valine for all animal species. For the supplemental L-valine to be as efficacious in ruminant as in non-ruminant species, it requires protection against degradation in the rumen.

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