,The EFSA CEP Panel has published a positive scientific opinion on the food enzyme ?-fructofuranosidase (?-D-fructofuranoside fructohydrolase; EC 3.2.1.26), produced by Beghin Meiji using a non-genetically modified Aspergillus sp. strain ATCC 20611. The enzyme is intended for use in the processing of sugars for the production of fructo-oligosaccharides (FOS). EFSA concluded that the food enzyme does not give rise to safety concerns under the intended conditions of use. Manufacturing and Exposure Considerations EFSA confirmed that the enzyme preparation is free from viable cells of the production organism. During FOS production, residual total organic solids (TOS) of the food enzyme are removed from the final FOS syrups. As a result, dietary exposure was not calculated, since consumer exposure is considered negligible. Toxicological Assessment Although not strictly required, toxicological studies were provided and assessed as supportive evidence: Genotoxicity studies did not indicate any safety concern. Systemic toxicity was evaluated through a 90-day repeated-dose oral toxicity study in rats. EFSA identified a No Observed Adverse Effect Level (NOAEL) of 920 mg TOS/kg body weight per day, corresponding to the highest dose tested. These findings further supported the safety of the enzyme preparation. Allergenicity Assessment A bioinformatic analysis comparing the amino acid sequence of ?-fructofuranosidase with known allergens did not identify any matches. While the Panel acknowledged that the possibility of allergic reactions upon dietary exposure cannot be completely excluded, it considered the likelihood of such reactions to be low, particularly given the removal of enzyme residues during processing. Regulatory Conclusion Based on the manufacturing process, lack of consumer exposure, toxicological data, and low allergenic potential, EFSA concluded that the ?-fructofuranosidase produced by Aspergillus sp. ATCC 20611 is safe for use in FOS production under the proposed conditions.
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