Safety evaluation of fibermalt

Fibermalt is a new soluble fiber food ingredient produced with the use of an alternansucrase enzyme from Leuconostoc mesenteroides expressed in a non-pathogenic strain of Escherichia coli. Fibermalt is predominantly composed of indigestible maltose alternan oligosaccharides (⩾80%). Fibermalt was non-mutagenic in a bacterial reverse mutation test. In a 13-week dietary rat study, fibermalt was administered at 0 (control), 50,000, 100,000 or 150,000 ppm. Statistically significant increases in food consumption were generally observed throughout the study in males receiving 100,000 or 150,000 ppm and in females receiving 100,000 ppm. However, there was no effect of fibermalt on mean body weight, body weight gain or food efficiency. All animals survived to scheduled termination and no adverse clinical signs were attributed to administration of fibermalt. There were no toxicologically relevant changes in hematology, clinical chemistry or urinalysis parameters or organ weights in males or females ingesting any concentration of fibermalt. Any macroscopic or microscopic findings were considered incidental, of normal variation and/or of minimal magnitude for test substance association. Based on these results, fibermalt is not mutagenic as evaluated in a bacterial reverse mutation test and has an oral subchronic (13-week) no observable adverse effect level (NOAEL) of 150,000 ppm in rats.