Italia
Published on: Tue, 07 Mar 2017 +0100
Endofeed® DC is a preparation of endo-1,3(4)-β-glucanase and endo-1,4-β-xylanase to be used as a feed additive for chickens for fattening, laying hens, pigs for fattening and minor poultry and porcine species. In a previous assessment, the safety of the additive for the target species, user and environment as well as the efficacy were established. In that assessment, the applicant provided in order to address the safety for the consumer, a bacterial reverse mutation assay and an in vitro micronucleus test, and a subchronic oral toxicity study. However, considering the limitations on the description of the manufacturing process, the characterisation of the additive and on the toxicological studies provided, the Panel could not conclude on the safety for the consumer. The applicant provided new data/information on the manufacturing process, characterisation of the additive and new toxicological studies, to support the safety for the consumer, which was the main subject of this opinion. Complete and detailed information regarding the manufacturing process of the additive, including details on the composition of the intermediate products were provided. With the new information on the manufacturing and on the test items used in the toxicological studies evaluated in 2013, the Panel identified the need for new genotoxicity studies, while confirmed the appropriateness of the test item used in the subchronic oral toxicity study. New genotoxicity studies were submitted by the applicant and the results of the tests showed no genotoxic potential of the test items. The Panel considered that the conclusions drawn in the subchronic oral toxicity study previously submitted can be considered valid; the results showed no evidence for adverse effects. Therefore, the Panel concluded that the additive is safe for the consumers when used as a feed additive.
© European Food Safety Authority, 2015
