Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified Komagataella phaffii strain DSM 34125

TL;DR

This study evaluates the safety of a food enzyme produced by a genetically modified yeast and concludes it is safe for use in food manufacturing.

Contribution

The study provides a safety assessment of a genetically modified yeast-derived food enzyme for use in food processes.

Findings

The enzyme is free from viable cells and DNA of the production organism.

Dietary exposure estimates are low, up to 0.039 mg TOS/kg body weight per day.

No homology to known allergens was found, though a low risk of allergic reactions cannot be excluded.

Abstract

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the genetically modified Komagataella phaffii strain DSM 34125 by Chr. Hansen. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in four food manufacturing processes. Dietary exposure was estimated to be up to 0.039 mg total organic solids (TOS)/kg body weight per day in European populations. Given the qualified presumption of safety status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, toxicity tests were considered unnecessary by the Panel. A search for the homology of the amino acid sequence of the triacylglycerol lipase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure cannot be excluded, but that the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.