Toxicological studies on Thermomyces lanuginosus xylanase expressed by Fusarium venenatum, intended for use in food

Abstract

The xylanase used in this study was produced by a submerged fermentation of Fusarium venenatum and contained a gene code originating from Thermomyces lanuginosus. The enzyme was subject to a 13-week toxicological test in rats and in vitro tests to document its safety in use. The enzyme is to be applied as a processing aid in the baking industry to improve handling and stability of dough. The enzyme was not found to be mutagenic in the Salmonella typhimurium reverse mutation assay, nor did it cause chromosomal aberrations in cultured human lymphocytes. Oral administration to rats of up to 10.0 ml/kg bw/day (equivalent to a Total Organic Solids dosage of 1.12 g/kg bw/day or a xylanase dosage of 89422 FXU (W)/kg bw/day) for 13 weeks did not cause any adverse effect.

Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA - Opinion of the Scientific Committee

“…The major concern is that F. venenatum is a potential producer of mycotoxins, such as trichothecenes (diacetoxyscirpenol [DAS]) and several derivatives thereof, nivalenol and fusarenon X), butenolide and culmorin (Thrane and Hansen 1995;Miller 2000;Nielsen and Thrane 2001), which are carefully controlled and monitored during mycoprotein production (Johnstone 1998). Strains of F. venenatum which are used to produce enzymes are genetically modified (Royer, Moyer et al 1995;Royer, Christianson et al 1999;Pedersen and Broadmeadow 2000;Ahmad, Brinch et al 2004).…”

Comparison of hazards: Current vs. GMO wine

“…There is no evidence that recombinant proteins in newly developed foods are more allergenic than traditional proteins (Lehrer, Horner, & Reese, 1996). In addition, proteins (glucanases, xylanases) were tested on food and feed safety and no adverse eVects have been observed (Coenen, Schoenmakers, & Verhagen, 1995;EFSA, 2005;Elveg & Pedersen, 2003;FDA/CFSAN/OPA, 2001;Material Safety Data, 1994Pedersen & Broadmeadow, 2000). Table 4 Risk characterization in wine production for conventional, IPGW, organic, biodynamic, GMO resistant on GFLV and GMO polysaccharide degrading yeast ¤¤ It means not only other stricto sensu damage impacts on human health, but also other eVects (adverse sensorial sensations, presence of some compounds (bacteriocin etc.)…”

Toxicological studies on Lactose Oxidase from Microdochium nivale expressed in Fusarium venenatum

“…The number of viable bacteria in each culture was determined by plate count. The methods used in this study have earlier been described by Pedersen and Broadmeadow (2000).…”