Bg. Lissau et al., SAFETY EVALUATION OF A FUNGAL PECTINESTERASE ENZYME PREPARATION AND ITS USE IN FOOD, Food additives and contaminants, 15(6), 1998, pp. 627-636
The Aspergillus aculeatus pectinesterase enzyme is used to modify the
texture of plant derived products. It is produced by A. oryzae transfo
rmed with the cloned full length cDNA of A. aculeatus encoding pectine
sterase. It was subjected to a series of toxicological tests to docume
nt safety in use. The enzyme preparation was not found to be mutagenic
in the Ames test, and did not cause chromosomal damage in a human lym
phocyte assay. In a 13-week oral-toxicity study in rats, with daily do
sages up to 10g enzyme preparation/kg body weight (b.w.), there were n
o adverse effects on mortality, clinical signs, body weight, food or w
ater consumption, ophthalmoscopic findings, haematology or clinical ch
emistry. There were also no notable necropsy or histological findings.
Statistically significant increases in heart weight were noted in mal
e animals treated with 5 or 10 g enzyme preparation/kg b.w./day, follo
wing covariance analysis. However, this was not considered to be relat
ed to treatment with the enzyme preparation. The issue of the levels o
f free liberation of methanol in products processed with pectinesteras
e is addressed, and it is concluded that, from a nutritional and physi
ological point of view, free as well as bound methanol must be conside
red.