Safety evaluation of the food enzyme acylglycerol lipase from the genetically modified Penicillium sp. strain AE-LGS

Abstract

The food enzyme acylglycerol lipase (glycerol-ester acylhydrolase, EC 3.1.1.23) is produced with the genetically modified Penicillium sp. strain AE-LGS by Amano Enzyme Inc. The Panel could not conclude on the taxonomic identification of the production strain due to a lack of appropriate data. The genetic modifications do not give rise to safety concerns. The food enzyme was free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in two food manufacturing processes. The compositional data provided were insufficient to characterise the food enzyme batches for commercialisation and the batch used for toxicological testing. As a result, the suitability of the batch used in the toxicological tests could not be established. The toxicological studies were thus not considered and the dietary exposure not calculated. A search for the homology of the amino acid sequence of the acylglycerol lipase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but the likelihood is low. Taken together, due to insufficient data regarding the production strain and the food enzyme composition, the Panel could not complete the safety assessment of the food enzyme.