Report | |||
| Status | Finished | EFSA question number | EFSA-Q-2023-00246 |
| Adopted | 14-04-2026 | ||
| Previous authorisations | The applicant has submitted a dossier in support of the application for authorisation of the food enzyme containing aspergillopepsin I and carboxypeptidase activities from a non-genetically modified A. sojae strain ACP 112–311. Additional information, requested from the applicant during the assessment process on 20 December 2023 and 31 March 2026, was received on 19 June 2024 and 9 April 2026, respectively. | ||
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 the solid biomass is removed from the fermentation broth by centrifugation followed 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 membrane and is discarded |
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| Average TOS (w/w) | 16.1 | Average activity/TOS | 19.5 |
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 alcohol, 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, particularly for wheat allergic individuals, cannot be excluded. However, the likelihood of such reactions will not exceed the risk of reactions after wheat consumption |
| Antimicrobial resistance | No antimicrobial activity was detected in any of the tested batches | ||
| Antifoam agents | / | Other | Strains of Aspergillus species, in common with most filamentous fungi, have the capacity to produce a range of secondary metabolites. Furthermore, the production strain ACP 112–311 was shown to be capable of producing kojic acid. The presence of aflatoxins (B1, B2, G1, G2), ochratoxin A, sterigmatocystin, T-2 toxin, zearalenone, kojic acid, cyclopiazonic acid and 3-nitropropionic acid was examined in batches 1, 2 and 3 and was below the limit of detection (LoD) of the applied methods. |
| Pathogens | |
Microbiological quality indicators | |
| Metals | |
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| Comments | LoQs: Pb = 0.05 mg/kg; As = 0.1 mg/kg. 29LoD yeast and moulds = 10 CFU/g. LoDs: aflatoxins (B1, B2, G1, G2), ochratoxin A = 0.5 μg/kg each; sterigmatocystin, zearalenone = 100 μg/kg each; T-2 toxin = 0.1 mg/kg; kojic acid, cyclopiazonic acid, 3-nitropropionic = 1 mg/kg each. | ||