Safety evaluation of the food enzyme endo-1,4-β-xylanase from the genetically modified Trichoderma reesei strain Dp-Nzd66



 

Report

Status Finished EFSA question number EFSA-Q-2023-00653
Adopted 11-03-2026
Previous authorisations The applicant has submitted a dossier in support of the application for authorisation of the food enzyme endo-1,4-β-xylanase from Trichoderma reesei strain DP-Nzd66. Additional information were requested during the risk assessment phase.

Production method

Manufacturing The production strain is grown as a pure culture using a typical industrial medium in a submerged, batch or fed-batch 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 the enzyme protein is retained, while most of the low molecular mass material passes the membrane and is discarded

Average TOS (w/w) 12.3 Average activity/TOS 9999.0

EFSA tested impurities

Production strain and recombinant DNA The absence of viable cells of the production strain in the food enzyme was demonstrated. The absence of recombinant DNA 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 and G2), fumonisin (B1 and B2), ochratoxin A, sterigmatocystin, T-2 toxin and zearalenone was examined in all food enzyme batches and all were below the limit of detection (LoD) of the applied methods
Pathogens
    		Microbiological quality indicators
      Metals
        Comments LoD: Pb = 0.01 mg/kg. LoDs: alfatoxins (total = 2 μg/kg; fumonisins (total) = 0.2 mg/kg; ochratoxin A = 2 μg/kg; sterigmatocystin = 10 μg/kg; T-2 toxin = 10 μg/kg; zearalenone = 5 μg/kg)