Safety evaluation of the food enzyme trypsin from porcine pancreas

The food enzyme trypsin (EC 3.4.21.4) is extracted from porcine pancreas by Ningbo Linzyme Biosciences Co., Ltd. It is intended to be used for the hydrolysis of whey proteins for use in infant formulae and follow-on formulae. Based on maximum use levels and the maximum permitted protein content in infant formula, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be 16.8 mg TOS/kg body weight (bw) per day for infants. In the toxicological evaluation, clinical studies with pancreatic enzymes were considered. Hypersensitivity to the pharmaceuticals was identified as the major side effect. However, allergic reactions to porcine pancreatic enzymes in hydrolysed foods have not been reported. The Panel considered that a risk of allergic sensitisation to this food enzyme after consumption of products prepared by hydrolysis of milk proteins could not be excluded in infants, but it considered the likelihood to be low. Based on the origin of the food enzyme from an edible tissue of pigs, the data provided by the applicant, the information from the evaluation of clinical studies based on pancreatic enzymes and the estimated dietary exposure, the Panel concluded that the trypsin from porcine pancreas does not give rise to safety concerns under the intended conditions of use.