Ensuring Safety: EU Assessment of Genetically Modified Aspergillus Niger Strain AGN's Production of Asparaginase

In a recent development, the European Union (EU) has conducted an evaluation of the safety of asparaginase produced by the genetically modified Aspergillus niger strain AGN. The assessment aimed to determine the potential risks associated with the use of this enzyme in food processing. This article provides an overview of the EU's evaluation and its findings regarding the safety of asparaginase.

Asparaginase is a food enzyme produced by the genetically modified Aspergillus niger strain AGN, which is specifically designed to prevent the formation of acrylamide during food processing. The EU's expert panel evaluated the safety of this food enzyme under expected usage conditions.

Based on the assessment, the expert panel acknowledged that there is a low possibility of allergic reactions caused by dietary exposure to asparaginase. Although the risk of allergenic reactions cannot be completely ruled out, the likelihood is minimal. The evaluation considered the data provided and concluded that the intended use of this food enzyme does not pose any safety concerns.

The genetic modifications applied to the Aspergillus niger strain AGN did not raise any safety issues according to the evaluation. The food enzyme is free from viable cells of the production organism and its DNA. These factors contribute to ensuring the safety of the enzyme for consumption.

Toxicity studies were conducted using an asparaginase derived from A. niger (strain ASP). The results indicated that this food enzyme is a suitable substitute for the tested asparaginase in toxicological studies. The genetic differences between the production strains were not expected to result in different toxigenic potentials. Moreover, the raw materials and manufacturing processes of both food enzymes were found to be comparable.

Considering the estimated dietary exposure, the panel identified a no observed adverse effect level of 1038 mg total organic solids (TOS) per kilogram of body weight (bw) per day, resulting in a substantial margin of exposure. Genotoxicity tests conducted did not raise any safety concerns.

The EU's evaluation of the genetically modified Aspergillus niger strain AGN's production of asparaginase confirms its safety under the intended conditions of use. While there is a minimal possibility of allergic reactions, the overall risk is deemed low. This assessment provides valuable insights into ensuring the safety of genetically modified food enzymes and contributes to the ongoing efforts in maintaining food safety standards.