Report | |||
| Status | Finished | EFSA question number | EFSA-Q-2023-00877 |
| Adopted | 04-02-2026 | ||
| Previous authorisations | The applicant has submitted a dossier in support of the application for authorisation of the food enzyme Ribonuclease P from a non-genetically modified P. citrinum strain AE-RPE. Additional information was requested from the applicant during the assessment phase on 21 October 2024 and on 10 June 2025, and they were received on 30 May 2025 and on 16 June 2025, respectively. | ||
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, the solid biomass is removed from the fermentation broth by filtration. The filtrate 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. |
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| Average TOS (w/w) | 50.5 | Average activity/TOS | 223.7 |
EFSA tested impurities | |||
| Production strain and recombinant DNA | The absence of viable cells of the production strain in the food enzyme was demonstrated. | Allergenicity | In conclusion, 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 | P. citrinum is known to produce the toxin citrinin, which was analysed in the three commercial batches and was below LoQ of the applied method. In addition, the presence of aflatoxins (B1, B2, G1, G2), HT-2 toxin, T-2 toxin, zearalenone, ochratoxin A and sterigmatocystin was examined in the three food enzyme batches and all were below the limits of quantification (LoQs) of the applied analytical methods. |
| Pathogens | |
Microbiological quality indicators | |
| Metals | |
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| Comments | LoQ: Pb = 0.01 mg/kg. LoQ: citrinin = 100 μg/kg. LoQs: aflatoxins (B1, B2, G1 and G2) = 0.2 μg/kg each; HT-2 toxin = 10 μg/kg; T-2 toxin = 10 μg/kg; zearalenone = 10 μg/kg; ochratoxin A = 0.5 μg/kg; sterigmatocystin = 10 μg/kg. | ||