Safety evaluation of the food enzyme arabinan endo-1,5-α-l-arabinanase from the non-genetically modified Aspergillus tubingensis strain ARS R7-60



 

Report

Status Finished EFSA question number EFSA-Q-2023-00245
Adopted 11-03-2026
Previous authorisations The applicant has submitted a dossier in support of the application for authorisation of the food enzyme arabinan endo-1,5-α-l-arabinanase from a non-genetically modified A. tubingensis ARS R7-60. Additional information was requested from the applicant during the assessment process on 20 December 2023 and received on 20 March 2024

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 enzyme is extracted with [...] and then the solid biomass is removed from the suspension by centrifugation. The supernatant 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) 17.8 Average activity/TOS 7.7

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 aflatoxins (B1, B2, G1, G2), ochratoxin A, sterigmatocystin, T-2 toxin, zearalenone and fumonisins (B1, B2) was examined in all batches and was below the LoQ of the applied methods
Pathogens
    		Microbiological quality indicators
      Metals
        Comments LoQs: Pb = 5 mg/kg; As = 3 mg/kg. LoQs: aflatoxins (B1, B2, G1, G2), ochratoxin A = 0.5 μg/kg each; fumonisins (B1, B2) = 0.5 mg/kg; sterigmatocystin, zearalenone 100 μg/kg each; T-2 toxin = 0.1 mg/kg.