The European Union (EU) Evaluates the Safety of Food Enzyme Trypsin from Porcine Pancreas

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On June 16, 2021, the European Food Safety Authority published the “Safety Evaluation of Food Enzyme Trypsin from Porcine Pancreas” by Novozymes A/S. The research evaluation is based in accordance with regulation Article 12 of Regulation (EC) No 1331/2008.

The scope of the scientific report is herein summarized:

  • The food enzyme is intended to be used for hydrolysis of whey proteins as ingredients in infant formulae, follow‐on formulae and in food for special medical purposes.
  • Based on maximum use levels and permitted protein content in infant formula, dietary exposure to the food enzyme–total organic solids (TOS) estimated to be 32 mg TOS/kg body weight/day for infants.
  • Toxicological evaluation, clinical studies with pancreatic enzymes were considered hypersensitive to the pharmaceuticals as the major side effect.
  • No allergic reactions to porcine pancreatic enzymes observed in hydrolyzed foods.
  • Low risk of allergic sensitization to food enzyme after consumption of products prepared by hydrolysis of milk in infants

The EFSA concluded that the trypsin from the porcine pancreas does not give rise to safety concerns under the intended conditions of use.

To view the complete assessment report, check out the Food News Monitoring System.

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