EU Evaluates The Safety Of Asparaginase Production By Genetically Modified Aspergillus Niger

On 15 July 2024, the European Food Safety Authority (EFSA) issued an assessment opinion on the safety of asparaginase (asparaginase) produced by a genetically modified Aspergillus Niger strain ASP.

This food enzyme is mainly used to prevent the formation of acrylamide in food, as well as the processing of yeast and yeast products. After assessment, the Panel concluded that this food enzyme does not raise safety concerns under the conditions of intended use. However, the risk that dietary exposure may cause an allergic reaction cannot be completely ruled out, although the likelihood of occurrence is low.

Specifically, the panel pointed out that the production strain of this food enzyme, ASP, was genetically modified, but the modification did not raise safety concerns. The maximum dietary exposure for the intended use of this enzyme is estimated to be 0.792 mg of total organic solids (TOS) per kilogram of body weight. Toxicological studies have found no safety concerns and no similarities to known allergens.

Based on the data provided, the expert panel concluded that this asparaginase produced by genetically modified strains of Aspergillus Niger is safe under the conditions of intended use. However, the risk of allergic reactions in a small number of people cannot be completely ruled out.