SAFETY EVALUATION OF A FUNGAL PECTINESTERASE ENZYME PREPARATION AND ITS USE IN FOOD

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.