Report | |||
| Status | Finished | EFSA question number | EFSA-Q-2023-00016 |
| Adopted | 08-10-2025 | ||
| Previous authorisations | The applicant has submitted a dossier in support of the application for authorisation of the food enzyme triacylglycerol lipase from the pregastric tissues of calves, kids and lambs. Additional information was requested from the applicant during the assessment phase on 25 April 2023, 23 April 2024 and 23 September 2025, and they were received on 26 September 2023, 14 May 2024 and 26 September 2025, respectively | ||
Production method | |||
| Manufacturing | The food enzyme is extracted from the pregastric tissues of calves, kids and sheep. The frozen tissues are thawed and then trimmed and ground. The ground tissue is then mixed with acid and pH controlling agent, milled and homogenised | Formulation | Unknown |
| Downstream processing | The obtained extract is filtered and further concentrated by 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) | 2.0 | Average activity/TOS | 1.7 |
EFSA tested impurities | |||
| Production strain and recombinant DNA | / | 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 the likelihood is low |
| Antimicrobial resistance | / | ||
| Antifoam agents | / | Other | / |
| Pathogens | |
Microbiological quality indicators | |
| Metals | |
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| Comments | LoDs: Pb = 0.0010–0.010 mg/kg; As = 0.010–0.10 mg/kg; Cd = 0.0004–0.004 mg/kg; Hg = 0.0010–0.010 mg/kg | ||