Abstract

Ronozyme® Rumistar is a preparation of alpha-amylase produced by a genetically modified strain of Bacillus licheniformis which is intended for use as a zootechnical feed additive for dairy cows. The FEEDAP Panel issued an opinion on the safety and efficacy of this product as a feed additive for dairy cows. The assessment performed considered the characterisation of the product, the safety aspects for the consumer, user and environment, as well as for the genetic modification of the production strain and the efficacy of the product for the target species. However, the Panel could not draw conclusions on the efficacy of the product. The additive is intended to be used in lactating dairy cows fed a plant-based diet of “medium starch content”. The applicant provided additional data on one study already evaluated. In a reduced set of data, the results showed a significant increase in cows fed Ronozyme® Rumistar compared with control cows when fed a total mixed ration diet with a normal starch content. Additionally, one digestibility study was provided but cannot be considered because of the parameters measured. Considering all the data made available by the applicant, no conclusions can be drawn on the efficacy of Ronozyme® Rumistar in dairy cows.

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