Report | |||
| Status | Finished | EFSA question number | EFSA-Q-2014-00839 |
| Adopted | 08-09-2026 | ||
| Previous authorisations | The applicant has submitted a dossier in support of the application for authorisation of the food enzyme Pectinase, Polygalacturonase, Pectinesterase, Pectin lyase and Arabanase from Aspergillus niger (strain ASNSC). The dossier was submitted in September 2014. Additional information requested from the applicant during the assessment phase on 17 March 2026 and were received on 17 June 2026. | ||
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 suspension 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. |
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| Average TOS (w/w) | 71.6 | Average activity/TOS | 32.6 |
EFSA tested impurities | |||
| Production strain and recombinant DNA | The absence of viable cells of the production strain in the food enzyme was demonstrated. | Allergenicity | In conclusion, the Panel considered that, under the intended conditions of use, a 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 | The presence of aflatoxins (B1, B2, G1, G2, M1), fumonisin B1, ochratoxin A, zearalenone, deoxynivalenol, nivalenol, T2-toxin, HT2-toxin, ergocornine, ergocristine, ergocriptine, ergometrine, ergosine and ergotamine was examined in all food enzyme batches and all were below the LoQ of the applied methods. |
| Pathogens | |
Microbiological quality indicators | |
| Metals | |
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| Comments | LoQs: Pb, As, Cd = 0.1 mg/kg each; Hg = 0.025 mg/kg. LoQs: aflatoxins (B1, B2, G1, G2) = 1 μg/kg each; aflatoxin M1 = 0.4 μg/kg; fumonisin B1 = 100 μg/kg; ochratoxin A = 5 μg/kg; zearalenone = 10 μg/kg; deoxynivalenol = 25 μg/kg; nivalenol = 800 μg/kg; T2-toxin = 5 μg/kg; HT2-toxin = 50 μg/kg; ergocornine, ergocristine, ergocriptine, ergometrine, ergosine and ergotamine = 100 μg/kg each. | ||