EU Safety evaluation of Food Enzyme β‐galactosidase from Genetically Modified Bacillus licheniformis

Posted By: Trace One

Trace One_fda-food-standard-identityOn June 30th, 2022, the European Food Safety Authority on Food Contact Materials, Enzymes, and Processing Aids published the assessment “Safety evaluation of the food enzyme βgalactosidase from the genetically modified Bacillus licheniformis strain NZYMBT” in accordance with Article 12 of Regulation (EC) No 1331/2008.


The document on the enzyme evaluation outlines the below:

  • The food enzyme is intended to be used in milk processing for the hydrolysis of lactose;
  • Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.34 mg TOS/kg body weight (bw) per day;
  • Toxicological data study supports the safety of the food enzyme;
  • The food enzyme does not give rise to safety concerns under the intended conditions of use;
  • Dietary exposure and risk of allergic sensitization cannot be excluded in individuals sensitized to galactosidase or to the matching allergen of pollen from Platanus;
  • Genotoxicity tests and genetic modifications of the enzyme do not raise a safety concern.

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