Following a request from the European Commission, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was asked to deliver a scientific opinion on the food enzyme thrombin (EC 126.96.36.199) obtained from blood plasma of cattle and pigs.
The food enzyme is obtained from cattle and pig’s blood that is fit for human consumption and is processed hygienically. The food enzyme is used together with added fibrinogen; the thrombin catalyses the transformation of fibrinogen to fibrin, which interacts with collagen, enabling the binding of meat/fish pieces resulting in meat preparations, meat products and fishery products.
The typical use and the recommended maximum use levels of the food enzyme have been provided.
Dietary exposure to thrombin from its use as a food enzyme was estimated using the EFSA Comprehensive European Food Consumption Database. The estimated mean and 95th percentile exposure across five population groups ranged from 3 to 12 µg TOS/kg body weight/day and from 6 to 24 µg TOS /kg bw/day, respectively.
The food enzyme has been characterised by determining the temperature and pH optima and the thermostability. Its composition is characterised by measuring the enzyme activity, content of protein and total organic solids.
As the food enzyme is derived from edible parts of animals, no toxicological tests are required.
Considering the origin of the food enzyme, the CEF Panel considers that the likelihood of a food allergic reaction to this thrombin is low and, therefore, it does not give rise to safety concerns.
Based on the origin of the food enzyme from edible parts of animals, the manufacturing process, and the compositional and biochemical data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.