Report | |||
| Status | Finished | EFSA question number | EFSA-Q-2023-00228 |
| Adopted | 08-09-2026 | ||
| Previous authorisations | The applicant has submitted a dossier in support of the application for authorisation of the food enzyme glucoamylase from Aspergillus niger strain CCTCC M 2023310. Additional information, requested from the applicant during the assessment process on 24 November 2023 and 12 June 2026, was received on 21 May 2024 and 10 September 2026, respectively. | ||
Production method | |||
| Manufacturing | The Panel is not in the position to evaluate the manufacturing process for the food enzyme under assessment. | Formulation | Unknown |
| Downstream processing | The Panel is not in the position to evaluate the manufacturing process for the food enzyme under assessment. |
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| Average TOS (w/w) | 91.3 | Average activity/TOS | 399.8 |
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, 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 glucan 1,4-α-glucosidase 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 and G2, deoxynivalenol (DON), fumonisin B1 and B2, ochratoxin A, sterigmatocystin, T2-toxin and HT2-toxin and zearalenone was examined in two food enzyme batches. All were below the LoQ of the applied analytical methods, except for DON (90 μg/kg) and the sum of fumonisins B1 and B2 (800 μg/kg) in the batch produced for toxicological studies, and zearalenone (22 μg/kg) in another batch. Using the highest estimated dietary exposure of 26.829 mg TOS/kg body weight (bw) per day as the reference, the concentration of DON, fumonisins and zearalenone in the food enzyme batches corresponds to 2.64, 23.5 and 0.65 ng/kg bw per day in the regular diet of consumers, respectively. They are several orders of magnitude lower than the tolerable daily intake (TDI) for DON (1 μg/kg bw per day, EFSA CONTAM Panel, 2017), fumonisins (1 μg/kg bw per day, EFSA CONTAM Panel, 2018) and zearalenone (0.25 μg/kg bw per day, EFSA CONTAM Panel, 2011), respectively. The Panel considered that the information provided on the purity of the food enzyme was sufficient. |
| Pathogens | |
Microbiological quality indicators | |
| Metals | |
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| Comments | LoQs: Pb = 0.05 mg/kg; Cd, Hg = 0.005 mg/kg each. LoQs: aflatoxin B1 = 0.1 μg/kg, aflatoxin B2 = 0.03 μg/kg, aflatoxin G1 = 0.1 μg/kg, aflatoxin G2 = 0.03 μg/kg, DON = 20 μg/kg, fumonisin B1 = 20 μg/kg, fumonisin B2 = 20 μg/kg, ochratoxin A = 0.2 μg/kg, sterigmatocystin = 10 μg/kg, T2-toxin = 10 μg/kg, HT2-toxin = 10 μg/kg, zearalenone = 10 μg/kg. | ||