EU Safety Assessment of Food Enzyme with Phospholipase A1 and Hemolytic Phospholipase Activities

The European Union (EU) recently conducted a safety evaluation of a food enzyme that possesses phospholipase A1 and hemolytic phospholipase activities. This assessment, conducted by the EU Food Safety Authority, aimed to determine the safety of the enzyme for use in food production. The results of the evaluation were published on May 6, 2024, shedding light on the potential risks associated with this particular food enzyme.

The EU Food Safety Authority recently released its opinion on the safety evaluation of a food enzyme with phospholipase A1 and hemolytic phospholipase activities. This specific enzyme is produced by a genetically modified strain of Aspergillus niger called PLN. Its intended use is in the production of refined edible fats and oils through the degumming process.

During the assessment, a panel of experts concluded that, under the intended conditions of use, the food enzyme does not pose any safety concerns. The genetic modifications made to the Aspergillus niger strain were deemed to be without any safety implications. Furthermore, the food enzyme is free from viable cells of the production organism and its DNA.

While it was acknowledged that there may be a low risk of allergic reactions upon dietary exposure, based on the available data, the likelihood of such reactions occurring was considered to be minimal. The panel conducted a search for similarities between the amino acid sequence of the food enzyme and known allergens but found no matches. Consequently, the conclusion drawn was that, given the anticipated usage conditions, this food enzyme does not give rise to safety concerns.

It's important to note that the evaluation did not involve the calculation of dietary exposure or the need for toxicological studies, as residual amounts of total organic solids are removed during the degumming process. Therefore, the focus of the assessment was primarily on the enzyme's potential to trigger allergic reactions.

In summary, the EU Food Safety Authority's safety evaluation of the food enzyme with phospholipase A1 and hemolytic phospholipase activities concluded that, when used as intended, the enzyme does not raise any safety concerns. While a low risk of allergic reactions cannot be completely excluded, the available data suggests that the likelihood of such reactions occurring is minimal.