EU Evaluates the Safety of beta -Galactosidase Produced by Genetically Modified Bacillus licheniformis Strain DSM 34099

In its latest official notice, published on 7 August 2024, EFSA published its comprehensive assessment of the safety of β-galactosidase in the food sector following a detailed and in-depth analysis of the safety of β-galactosidase produced under a specific transgenic strain, DSM 34099. This enzyme, as an indispensable food additive, has occupied a pivotal position in many areas of the food industry, especially in the manufacturing process of two specific food products.

β-galactosidase, a hydrolytic enzyme commonly found in microbial, plant and animal cells, has a core function of efficiently catalyzing the cleavage of the glycoside bond between the β-D-galactoside unit of lactose and the glycoside ligand, thereby converting lactose into glucose and galactose. In addition, this enzyme has shown unique value in the field of molecular biology and is often used as an important indicator of gene expression levels. It is unique in that when β-galactosidase reacts with the substrate X-gal, it can produce a bright blue product, which makes it play a crucial role in blue/white colony screening. More remarkable is that β-galactosidase also plays a role in the end of the cell life cycle, that is, the cell aging stage, which cannot be ignored. As cells age, the activity of this enzyme increases significantly, and this phenomenon becomes a powerful biomarker for identifying senescent cells. By precisely measuring the level of beta-galactosidase activity in cells, scientists can accurately assess how old cells are.

After a thorough and detailed analysis, the evaluation team noted that although the enzyme poses little threat to food safety under the intended conditions of use, they nevertheless stressed that the potential risk of anaphylaxis for certain groups of people with kiwi allergy should not be ignored. Based on currently available data, the panel concluded that the enzyme does not pose an additional safety risk to the overall health of consumers during normal food processing and consumption.

EFSA further stressed that the strain producing the enzyme, DSM 34099, fully complies with the Qualified Presumption of Safety (QPS) standard established by the European Union, which indicates that the strain is considered safe under conditions of routine use. In addition, in order to ensure the absolute safety of the product, strict measures have been taken during the production process to completely remove all living cells and DNA components, thus greatly reducing the risk of genetic material transfer.

However, in view of the potential risks associated with kiwi allergy, the European Food Safety Authority (EFSA) still reminds consumers to exercise the necessary vigilance and caution when enjoying foods containing this enzyme. This recommendation aims to protect those consumers who have an allergic reaction to kiwifruit in a comprehensive manner to ensure that they can fully understand the ingredients and potential risks of the food they consume while tasting the food, so as to protect their health and safety.