Report | |||
| Status | Finished | EFSA question number | EFSA-Q-2024-00205 |
| Adopted | 25-06-2025 | ||
| Previous authorisations | The applicant has submitted a dossier in support of the application for authorisation of the food enzyme aspergillopepsin I from a non-genetically modified A. oryzae strain AE-PRHF. Additional information, requested from the applicant during the assessment phase on 21 January 2025, were received on 18 April 2025 | ||
Production method | |||
| Manufacturing | The production strain is grown as a pure culture using a typical industrial medium in fermentation system with conventional process controls in place | Formulation | Unknown |
| Downstream processing | After completion of the fermentation, the enzyme is and the solid biomass is removed from the suspension broth by filtration. The filtrate containing the enzyme is then further purified and concentrated, including (...) in which the enzyme protein is retained, while most of the low molecular mass material passes the filtration membrane and is discarded |
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| Average TOS (w/w) | 94.5 | Average activity/TOS | 262.7 |
EFSA tested impurities | |||
| Production strain and recombinant DNA | The absence of viable cells of the production strain in the food enzyme was demonstrated. | Allergenicity | when used for the production of distilled alcohols, the Panel considered that a risk of allergic reactions upon dietary exposure can be excluded. For the remaining intended uses, the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is low |
| Antimicrobial resistance | No antimicrobial activity was detected in any of the tested batches | ||
| Antifoam agents | / | Other | The presence of aflatoxin B1, B2, G1, G2, deoxynivalenol, T-2 toxin, HT-2 toxin, zearalenone, ochratoxin A, sterigmatocystin was examined in all food enzyme batches and all were below the limit of quantification (LoQ) of the applied methods. |
| Pathogens | |
Microbiological quality indicators | |
| Metals | |
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| Comments | LoQ: Pb = 0.05 mg/kg. LoQs: aflatoxin B1, B2, G1, G2 = 1 μg/kg each; deoxynivalenol = 0.05 mg/kg; T-2 toxin = 0.01 mg/kg, HT-2 toxin = 0.05 mg/kg; zearalenone = 0.05 mg/kg; ochratoxin A = 5 μg/kg; sterigmatocystin = 0.05 mg/kg. | ||