Report | |||
| Status | Finished | EFSA question number | EFSA-Q-2024-00307 |
| Adopted | 14-04-2026 | ||
| Previous authorisations | The applicant has submitted a dossier in support of the application for authorisation of the food enzyme amidase from E. coli strain SP-a. Additional information was requested during the risk assessment phase. Following the request for additional data sent by EFSA on 05 May 2025, the applicant requested a clarification teleconference on 20 June 2025, after which the applicant provided additional data on 30 July 2025. Following the request for additional data sent by EFSA on 13 October 2025, the applicant requested another clarification teleconference on 4 November 2025, after which the applicant provided additional data on 13 January 2026. | ||
Production method | |||
| Manufacturing | The production strain is grown as a pure culture using a typical industrial medium in a submerged, batch or fed-batch fermentation system with conventional process controls in place. | Formulation | Unknown |
| Downstream processing | After completion of the fermentation, cells are harvested by centrifugation and then mechanically disrupted to release the intracellular enzyme. Afterwards, the cell homogenate is treated with nuclease to degrade DNA, and the solid biomass is removed from the fermentation broth by centrifugation followed 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) | 8.3 | Average activity/TOS | 102.1 |
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 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 = 0.01 mg/kg; As = 0.01 mg/kg; Cd = 0.002 mg/kg; Hg = 0.002 mg/kg. | ||