Report | |||
| Status | Finished | EFSA question number | EFSA-Q-2023-00266 |
| Adopted | 11-03-2026 | ||
| Previous authorisations | The applicant has submitted a dossier in support of the application for authorisation of the food enzyme pectin lyase from a non-genetically modified Aspergillus luchuensis (strain LC-07). Additional information, requested from the applicant during the assessment process on 08 December 2023 and 26 January 2026, was received on 07 June 2024 and 2 February 2026, respectively. Following the reception of additional data, EFSA requested a clarification teleconference on 25 February 2026, after which the applicant provided additional data on 25 February 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 centrifugation followed by filtration. The filtrate containing the enzyme is 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) | 18.6 | Average activity/TOS | 52.7 |
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 alcoholic beverages, 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 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 aflatoxins (B1, B2, G1, G2), ochratoxin A, sterigmatocystin, T-2 toxin, zearalenone and fumonisins (B1, B2) was examined in all food enzyme batches and was below the LoQs 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. LoQs: aflatoxins (B1, B2, G1, G2) = 0.5 μg/kg; ochratoxin A = 0.5 μg/kg; fumonisins (B1, B2) = 0.5 mg/kg; sterigmatocystin = 100 μg/kg; zearalenone = 100 μg/kg; T-2 toxin = 0.1 mg/kg. | ||