Report | |||
| Status | Finished | EFSA question number | EFSA-Q-2023-00441 |
| Adopted | 03-02-2026 | ||
| Previous authorisations | The applicant has submitted a dossier in support of the application for authorisation of the food enzyme papain from Carica papaya L. as a new food enzyme. Additional information was requested four times during the risk assessment phase. | ||
Production method | |||
| Manufacturing | The food enzyme is obtained by aqueous extraction from papaya latex provided by a third-party supplier | Formulation | Unknown |
| Downstream processing | After the dried latex is rehydrated, the liquid containing the enzyme is filtrated and 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 food enzyme is spray-dried. Around 5 kg of dry latex is needed to produce 1 kg of papain. Taken into account the weight loss during drying (about 7 times), this corresponds to a yield factor of 0.03 (w/w, papain/fresh latex). The applicant provided information on the identity of the substances used in the extraction and in the subsequent downstream processing of the food enzyme. |
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| Average TOS (w/w) | 91.3 | Average activity/TOS | 904.7 |
EFSA tested impurities | |||
| Production strain and recombinant DNA | / | Allergenicity | / |
| Antimicrobial resistance | / | ||
| Antifoam agents | / | Other | The presence of aflatoxin B1, B2, G1, G2, deoxynivalenol, zearalenone and ochratoxin A was examined in three food enzyme batches. All were below the LoQ of the applied analytical methods. |
| Pathogens | |
Microbiological quality indicators | |
| Metals | |
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| Comments | LoQs: Pb, As, Cd = not provided; Hg = 0.005 mg/kg. LoQs: aflatoxins B1, B2, G1 and G2 = 1 μg/kg each; ochratoxin A = 1 μg/kg; deoxynivalenol = 100 μg/kg; zearalenone = 5 μg/kg. | ||