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 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.