Report | |||
| Status | Finished | EFSA question number | EFSA-Q-2023-00244 |
| Adopted | 18-06-2026 | ||
| Previous authorisations | The applicant has submitted a dossier in support of the application for authorisation of the food enzyme pectinase from Aspergillus luchuensis (strain AP2 903-6). Additional information, requested from the applicant during the assessment process on 21 May 2024 and 29 January 2025, was received on 23 August 2024 and 25 February 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 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 membrane and is discarded. |
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| Average TOS (w/w) | 19.1 | Average activity/TOS | 178.0 |
EFSA tested impurities | |||
| Production strain and recombinant DNA | The absence of viable cells of the production strain in the food enzyme. | Allergenicity | The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in pollen-allergic individuals, cannot be excluded. |
| Antimicrobial resistance | No antimicrobial activity was detected in any of the tested batches. | ||
| Antifoam agents | / | Other | / |
| Pathogens | |
Microbiological quality indicators | |
| Metals | |
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| Comments | LoQs: Pb = 0.05 mg/kg; As = 0.1 mg/kg. | ||