Revised dietary exposure assessment of the food enzyme thrombin from cattle (bovines) and pig's blood

Abstract The food enzyme thrombin (EC 3.4.21.5) is produced from cattle and pig's blood by Sonac. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that, under the intended conditions of use, this food enzyme did not give rise to safety concerns. Due to the im...

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Main Authors: EFSA Panel on Food Enzymes (FEZ), Holger Zorn, José Manuel Barat Baviera, Claudia Bolognesi, Francesco Catania, Gabriele Gadermaier, Ralf Greiner, Baltasar Mayo, Alicja Mortensen, Yrjö Henrik Roos, Marize L. M. Solano, Monika Sramkova, Henk Van Loveren, Laurence Vernis, Daniele Cavanna, Giulio Di Piazza, Yi Liu
Format: Article
Language:English
Published: Wiley 2025-01-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2025.9168
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author EFSA Panel on Food Enzymes (FEZ)
Holger Zorn
José Manuel Barat Baviera
Claudia Bolognesi
Francesco Catania
Gabriele Gadermaier
Ralf Greiner
Baltasar Mayo
Alicja Mortensen
Yrjö Henrik Roos
Marize L. M. Solano
Monika Sramkova
Henk Van Loveren
Laurence Vernis
Daniele Cavanna
Giulio Di Piazza
Yi Liu
author_facet EFSA Panel on Food Enzymes (FEZ)
Holger Zorn
José Manuel Barat Baviera
Claudia Bolognesi
Francesco Catania
Gabriele Gadermaier
Ralf Greiner
Baltasar Mayo
Alicja Mortensen
Yrjö Henrik Roos
Marize L. M. Solano
Monika Sramkova
Henk Van Loveren
Laurence Vernis
Daniele Cavanna
Giulio Di Piazza
Yi Liu
author_sort EFSA Panel on Food Enzymes (FEZ)
collection DOAJ
description Abstract The food enzyme thrombin (EC 3.4.21.5) is produced from cattle and pig's blood by Sonac. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that, under the intended conditions of use, this food enzyme did not give rise to safety concerns. Due to the implementation of a new methodology to estimate the dietary exposure to food enzymes in 2016, the European Commission requested EFSA to revise the exposure assessment of this food enzyme by using this new methodology. In this assessment, EFSA realigned the intended uses of this food enzyme to the processing of meat and fish products for the production of modified meat and fish products. The dietary exposure was calculated to be below 0.0001 mg total organic solids/kg body weight (bw) per day in European populations. The intake of prothrombin (the precursor of thrombin) from animal blood in the diet of European population is also below 0.0001 mg/kg bw per day. Based on the origin of the food enzyme from edible parts of animals, the previous evaluation of the manufacturing process and the compositional data, and the comparable exposure estimation between the use of the food enzyme and its source, the Panel concluded that the food enzyme thrombin derived from cattle (bovine) and pig's blood does not give rise to safety concerns under the intended conditions of use.
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publishDate 2025-01-01
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spelling doaj-art-61a6dfb5f4a044a3a793f6f6fd9febc52025-01-31T12:06:03ZengWileyEFSA Journal1831-47322025-01-01231n/an/a10.2903/j.efsa.2025.9168Revised dietary exposure assessment of the food enzyme thrombin from cattle (bovines) and pig's bloodEFSA Panel on Food Enzymes (FEZ)Holger ZornJosé Manuel Barat BavieraClaudia BolognesiFrancesco CataniaGabriele GadermaierRalf GreinerBaltasar MayoAlicja MortensenYrjö Henrik RoosMarize L. M. SolanoMonika SramkovaHenk Van LoverenLaurence VernisDaniele CavannaGiulio Di PiazzaYi LiuAbstract The food enzyme thrombin (EC 3.4.21.5) is produced from cattle and pig's blood by Sonac. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that, under the intended conditions of use, this food enzyme did not give rise to safety concerns. Due to the implementation of a new methodology to estimate the dietary exposure to food enzymes in 2016, the European Commission requested EFSA to revise the exposure assessment of this food enzyme by using this new methodology. In this assessment, EFSA realigned the intended uses of this food enzyme to the processing of meat and fish products for the production of modified meat and fish products. The dietary exposure was calculated to be below 0.0001 mg total organic solids/kg body weight (bw) per day in European populations. The intake of prothrombin (the precursor of thrombin) from animal blood in the diet of European population is also below 0.0001 mg/kg bw per day. Based on the origin of the food enzyme from edible parts of animals, the previous evaluation of the manufacturing process and the compositional data, and the comparable exposure estimation between the use of the food enzyme and its source, the Panel concluded that the food enzyme thrombin derived from cattle (bovine) and pig's blood does not give rise to safety concerns under the intended conditions of use.https://doi.org/10.2903/j.efsa.2025.9168bovine bloodEC 3.4.21.5EFSA‐Q‐2014‐00499EFSA‐Q‐2024‐00611food enzymepig blood
spellingShingle EFSA Panel on Food Enzymes (FEZ)
Holger Zorn
José Manuel Barat Baviera
Claudia Bolognesi
Francesco Catania
Gabriele Gadermaier
Ralf Greiner
Baltasar Mayo
Alicja Mortensen
Yrjö Henrik Roos
Marize L. M. Solano
Monika Sramkova
Henk Van Loveren
Laurence Vernis
Daniele Cavanna
Giulio Di Piazza
Yi Liu
Revised dietary exposure assessment of the food enzyme thrombin from cattle (bovines) and pig's blood
EFSA Journal
bovine blood
EC 3.4.21.5
EFSA‐Q‐2014‐00499
EFSA‐Q‐2024‐00611
food enzyme
pig blood
title Revised dietary exposure assessment of the food enzyme thrombin from cattle (bovines) and pig's blood
title_full Revised dietary exposure assessment of the food enzyme thrombin from cattle (bovines) and pig's blood
title_fullStr Revised dietary exposure assessment of the food enzyme thrombin from cattle (bovines) and pig's blood
title_full_unstemmed Revised dietary exposure assessment of the food enzyme thrombin from cattle (bovines) and pig's blood
title_short Revised dietary exposure assessment of the food enzyme thrombin from cattle (bovines) and pig's blood
title_sort revised dietary exposure assessment of the food enzyme thrombin from cattle bovines and pig s blood
topic bovine blood
EC 3.4.21.5
EFSA‐Q‐2014‐00499
EFSA‐Q‐2024‐00611
food enzyme
pig blood
url https://doi.org/10.2903/j.efsa.2025.9168
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