Opinion of the Panel on additives and products or substances used in animal feed (FEEDAP) on the safety and efficacy of the product “Amaferm” as a feed additive for dairy cows and cattle for fattening in accordance with Regulation (EC) No 1831/2003

Abstract

SUMMARYAmaferm is the fermentation product of a non-pathogenic and non-genetically modified strain of Aspergillus oryzae mixed with wheat bran as carrier. It is proposed to be used as feed additive to dairy cows and cattle for fattening at doses between 2 and 5 g head -1 day -1 in order to improve production performance.According to Regulation (EC) No 1831/2003, the European Food Safety Authority (EFSA) should deliver an opinion on the efficacy and the safety of the product Amaferm for the target animals, consumers, users and the environment.Amaferm has been shown to be capable of producing a positive effect on milk yield of dairy cows. However, evidence has only been provided for a dose of 3 g head -1 day -1 instead of the minimum recommended dose of 2 g head -1 day -1 claimed by the Applicant. However, only one out of four studies with cattle for fattening showed a persistent improvement of weight gain and feed conversion with Amaferm. Therefore, the FEEDAP Panel considers the data provided to be insufficient to draw final conclusions on efficacy of Amaferm in cattle for fattening kept under common production conditions. A tolerance study with lactating dairy cows demonstrated the absence of adverse effects of Amaferm on production performance. The FEEDAP Panel regards this study to be representative also for cattle for fattening and considers tolerance of Amaferm to be sufficiently demonstrated for both dairy cows and cattle for fattening. This includes also microbiological safety within the digestive tract of animals supplied with Amaferm.According to the long experience of use of fermentation products from Aspergillus oryzae as components of human food and reassurance of lack of aflatoxin production by the strain, the FEEDAP Panel has no reason for concern for consumer safety deriving from the use of Amaferm.The studies provided with the dossier did not give rise for safety concerns for consumer and user safety. However, the FEEDAP Panel considers that, as with all proteinaceous substances, there might be a risk of sensitisation by inhalation for those handling the product.The FEEDAP Panel recognises that Amaferm consists of natural substances with no environmental concern.No risks associated with the use of the product are foreseen, and therefore the FEEDAP Panel does not see the need for specific requirements for a post-market monitoring plan.

Assessment of the application for renewal of the authorisation of Amaferm® (fermentation product of Aspergillus oryzae NRRL 458) as a feed additive for dairy cows

“…This strain (NRRL 458) is deposited at the American Type Culture Collection under the deposit number ATCC 9376. 17,18 . 19 Moreover, in order to taxonomically identify the production strain, the applicant sent, upon request, an analysis but the comparison of the sequence did not permit to distinguish between A. oryzae and A. flavus.…”