Safety evaluation of the food enzyme β-fructofuranosidase from the non-genetically modified Aspergillus sp. strain ATCC 20611



 

Report

Status Finished EFSA question number EFSA-Q-2015-00840
Adopted 09-12-2025
Previous authorisations The applicant has submitted a dossier in support of the application for authorisation of the food enzyme β-fructofuranosidase from Aspergillus fijiensis (Strain ATCC® 20611™). Additional information was requested from the applicant during the assessment process on 28 February 2023 and received on 12 November 2023

Production method

Manufacturing The production strain is grown as a pure culture using a typical industrial medium in a […] fermentation system with conventional process controls in place. Formulation Unknown
Downstream processing

After completion of the fermentation, the solid biomass is removed from the fermentation broth by filtration. The filtrate containing the enzyme is then further purified and concentrated, including an ultrafiltration step in which enzyme protein is retained, while most of the low molecular mass material passes the filtration membrane and is discarded.

Average TOS (w/w) 92.1 Average activity/TOS 1574.0

EFSA tested impurities

Production strain and recombinant DNA The absence of viable cells of the production strain in the food enzyme was demonstrated. Allergenicity The Panel considered that under the intended conditions of use, a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, but that the likelihood is low.
Antimicrobial resistance No antimicrobial activity was detected in any of the tested batches.
Antifoam agents / Other The presence of ochratoxin A, aflatoxins (B1, B2, G1, G2) and sterigmatocystin was examined in all food enzyme batches and were below the limits of quantification of the applied analytical methods.
Pathogens
    		Microbiological quality indicators
      Metals
        Comments LoQs: Pb = 0.05 mg/kg; As = 0.1 mg/kg; Hg = 0.01 mg/kg; Cd = 0.03 mg/kg. LoQs: ochratoxin A = 5 μg/kg; aflatoxins (B1, B2, G1, G2) = 5 μg/kg each; sterigmatocystin = 50 μg/kg.