Safety evaluation of the food enzyme β-galactosidase from the non-genetically modified Aspergillus oryzae strain GL 470.

The food enzyme β-galactosidase (β-d-galactoside galactohydrolase; EC 3.2.1.23) is produced with the Aspergillus oryzae strain GL 470 by Shin Nihon Chemical Co., Ltd. The food enzyme is free from viable cells of the production organism. It is intended to be used in five food manufacturing processes; lactose hydrolysis in milk processing, production of fermented milk products, whey processing, manufacture of enzyme-modified dairy ingredients and in the manufacture of galacto-oligosaccharides. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 1.388 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of repeated dose 90-day oral toxicity studies in rats. The Panel identified a no observed adverse effect level of 7,000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 5,043. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel concluded that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. Based on the data provided and considering the most recent complete toxicological data set, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.