Safety evaluation of the food enzyme glucose oxidase from the non-genetically modified Penicillium rubens strain PGO 19–162

Abstract

The food enzyme glucose oxidase (β-d-glucose: oxygen 1-oxidoreductase; EC 1.1.3.4) is produced with the non-genetically modified Penicillium rubens strain PGO 19–162 by Shin Nihon Chemical Co. Ltd. The food enzyme was free from viable cells of the production organism. It is intended to be used in five food manufacturing processes. Dietary exposure was estimated to be up to 0.062 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 193 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 3113. A search for the homology of the amino acid sequence of the glucose oxidase to known allergens was made and matches with one food allergen and one contact allergen were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.