On October 30, the European Food Safety Authority (EFSA) published scientific opinion on the safety and efficacy of Econase® GT (endo-1,3(4)-beta-glucanase) as a feed additive for chickens for fattening and weaned piglets.
Abstract
Econase® GT is a feed additive with endo-1,3(4)-beta-glucanase as the declared enzymatic activity. The production strain for Econase® GT is a genetically modified Trichoderma reesei. Neither the production strain nor its recombinant DNA was detected in the final product. The final product does not raise any safety concerns with regard to the genetic modification of the production strain.
The results of tolerance trials in chickens for fattening and weaned piglets showed that the animals tolerated well 133 times the maximum recommended dosage (30 000 BU/kg feed).
Therefore, the FEEDAP Panel concludes that the additive is safe for these target species at the maximum recommended dose. The fermentation product used to prepare the final formulations of Econase® GT was shown not to be mutagenic in a bacterial reverse mutation study, in an in vitro cytogenetic assay in Chinese hamster V79 cells and in an in vivo bone marrow micronucleus test.
The results obtained in a sub-chronic oral toxicity study raised no concerns regarding the product. Therefore, based on the toxicological studies performed with the fermentation product, the additive gives rise to no concerns regarding consumer safety. Econase® GT in any of its forms should not be classified as a skin/eye irritant or a skin sensitiser. However, the additive should be treated as a potential respiratory sensitiser.
No risks to the environment are expected and no further environmental risk assessment is required. Based on the results of the efficacy trials in chickens for fattening and piglets, in which the additive significantly improved the performance of the animals, the Panel concludes that the additive has the potential to be efficacious at doses of 20 000 BU/kg feed in chickens for fattening and 10 000 BU/kg in weaned piglets.
