EU Publishes Safety evaluation of the food enzyme Trypsin from Porcine pancreas

Posted By: Trace One

On January 12th, 2022, the European Food Safety Authority published the “Safety evaluation of the food enzyme trypsin from porcine pancreas” in accordance with Article 29 of Regulation (EC) No 178/2002, and Article 17.3 of Regulation (EC) No 1332/2008 on food enzymes.


The scope of the safety assessment outlines the following:

  • Trypsin extracted from the porcine pancreas is intended to be used for the hydrolysis of whey proteins for use in infant formulae and followon formulae;
  • Maximum use levels and permitted protein content in infant formula, total organic solids (TOS) were observed at 16.8 mg TOS/kg body weight / per day for infants;
  • Toxicological evaluation with pancreatic enzymes indicated Hypersensitivity as a major side effect;
  • No Allergic reactions to porcine pancreatic enzymes in hydrolyzed foods have been identified;
  • The allergic reaction in infants after consumption of products due to milk protein hydrolysis is found to be of low risk;
  • Clinical study and dietary exposure studies resulted in the safety of additives under the intended conditions of use.

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