Report | |||
| Status | Finished | EFSA question number | EFSA-Q-2024-00453 |
| Adopted | 15-04-2026 | ||
| Previous authorisations | The applicant has submitted a dossier in support of the application for authorisation of the food enzyme xylanase from a genetically modified B. licheniformis strain NZYM-FX. Additional information were requested during the risk assessment phase. | ||
Production method | |||
| Manufacturing | The production strain is grown as a pure culture using a typical industrial medium in a submerged, fed-batch fermentation system with conventional process controls in place. | Formulation | Unknown |
| Downstream processing | After completion of the fermentation, the solid biomass is removed from the fermentation broth by filtration. The filtrate containing the enzyme is 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) | 6.5 | Average activity/TOS | 7.1 |
EFSA tested impurities | |||
| Production strain and recombinant DNA | The presence of viable cells of the production strain in the food enzyme was analysed in triplicate. No colonies of the production strain were detected. The absence of recombinant DNA in the food enzyme was demonstrated | Allergenicity | 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 use, 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 | / |
| Pathogens | |
Microbiological quality indicators | |
| Metals | |
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| Comments | Pb: Limit of quantification (LoQ) = 0.5 mg/kg. | ||