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On January 6, 2021, the European Food Safety Agency issued opinions on the safety evaluation of a food enzyme.
It is understood that this food enzyme contains trypsin and chymotrypsin from porcine pancreas, and is intended to be used to hydrolyze whey protein and used as an ingredient in infant formula and subsequent formulas.
After evaluation, the expert panel believes that the risk of allergic allergic sensitization to the food enzyme cannot be ruled out for infants after eating products made from hydrolyzed milk, but the possibility is considered very low. Based on the source of food enzymes in the edible parts of animals, the data provided by the applicant, and the support of clinical research and evaluation of pancreatin-based pharmaceutical preparations, the expert team concluded that under the expected use conditions, porcine pancreatin would not cause Security issues. Part of the original report is as follows:
The food enzyme is a serine protease complex, containing trypsin (EC 18.104.22.168) and chymotrypsin (EC 22.214.171.124), obtained from porcine pancreas by Neova Technologies Inc. The serine protease complex is intended to be used for hydrolysis of whey proteins employed as ingredients of infant formulae and follow‐on formulae. based on maximum use levels and the maximum permitted protein content in infant formulae, dietary exposure to the food enzyme –Total organic solids (TOS) was estimated to be 18 mg TOS/kg body weight (bw) per day for infants. In the toxicological evaluation, clinical studies with pharmaceutical preparations containing 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 co nsumption of p roducts prepared by hydrolysis of milk cannot be excluded in infants, but considers the likelihood to be low. based on the origin of the food enzyme from edible parts of animals, the data provided by the applicant , supported by the evaluation of clinical studies with pharmaceutical preparations based on pancreatic enzymes, the Panel concluded that the porcine pancreatic enzymes do not give rise to safety co ncern under the intended conditions of use.
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