Safety evaluation of the food enzyme β-fructofuranosidase from the genetically modified strain AR-996.

The food enzyme β-fructofuranosidase (β-d-fructofuranoside fructohydrolase; EC 3.2.1.26) is produced with the genetically modified strain AR-996 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes. Dietary exposure was estimated to be up to 0.605 mg total organic solids (TOS)/kg body weight 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 1000 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 1653. A search for the homology of the amino acid sequence of the β-fructofuranosidase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but the likelihood is low. Based on the data provided and the derived margin of exposure, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.