Report | |||
| Status | Finished | EFSA question number | EFSA-Q-2023-00242 |
| Adopted | 12-09-2025 | ||
| Previous authorisations | The applicant has submitted a dossier in March 2023 in support of the application for authorisation of the food enzyme cellulase from a non-genetically modified Aspergillus niger (strain ACH 12-525). The dossier was updated in July 2023 as an ‘application for the authorisation of endo-1,4-β-mannosidase from aspergillus niger strain ACH 12-525’. Additional information was requested from the applicant during the assessment phase on 13 July 2023 and 13 March 2024 and was received on 20 July 2023 and 12 June 2024, 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 water, and the biomass is removed from the fermentation broth by centrifugation, followed by microfiltration. The filtrate containing the enzyme is concentrated, including an ultrafiltration step 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) | 12.3 | Average activity/TOS | 294.0 |
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 aflatoxins (B1, B2, G1, G2), fumonisins (B1, B2), ochratoxin A, sterigmatocystin, T-2 toxin and zearalenone was examined in three food enzyme batches and was below the LoQ of the applied methods. |
| Pathogens | |
Microbiological quality indicators | |
| Metals | |
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| Comments | LoQ for batches 1–3: As = 0.1 mg/kg. LoQ for batch 4: 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. | ||