Report | |||
| Status | Finished | EFSA question number | EFSA-Q-2024-00310 |
| Adopted | 11-09-2025 | ||
| Previous authorisations | The applicant has submitted a dossier in support of the application for authorisation of the food enzyme d-psicose 3-epimerase from Escherichia coli strain K-12 W3110-TKO CDX-088. Additional information, requested from the applicant during the assessment process on 26 March 2025, was received on 21 April 2025 | ||
Production method | |||
| Manufacturing | The production strain is grown as a pure culture using a typical industrial medium in a submerged, […] fermentation system with conventional process controls in place. […] is added during fermentation to […]. | Formulation | Unknown |
| Downstream processing | After completion of the fermentation, the cells are harvested by centrifugation, resuspended and then mechanically disrupted by high-pressure homogenisation. Afterwards, the cell homogenate [...]. The solid biomass is removed 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 filtration membrane and is discarded. Finally, the enzyme solution is freeze-dried prior to analysis |
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| Average TOS (w/w) | 87.1 | Average activity/TOS | 116.9 |
EFSA tested impurities | |||
| Production strain and recombinant DNA | The absence of viable cells of the production strain in the food enzyme was demonstrated. The absence of recombinant DNA in the food enzyme was demonstrated. | Allergenicity | the Panel considered that, under the intended conditions of use, a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, but that 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 | LoQs: Pb = 0.005 mg/kg; As = 0.01 mg/kg; Cd = 0.005 mg/kg; Hg = 0.005 mg/kg. LoQ: IPTG = 125 mg/kg. | ||