EU Evaluates the Safety of Inulinase Produced by Non-GMO Aspergillus welwitschiae Strain NZYM-KF

On May 29, 2024, the European Food Safety Authority (EFSA) published its opinion on the safety evaluation of an inulinase enzyme. This food enzyme is produced by the non-genetically modified Aspergillus welwitschiae strain NZYM-KF and is intended to be used in the processing of fructo-polysaccharides for the production of fructo-oligosaccharides.

After evaluation, the EFSA expert panel concluded that under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitized to tomato, cannot be excluded. However, this risk is expected not to exceed that of consuming tomatoes, as the prevalence of allergic reactions to tomato is low.

Based on the data provided, the panel determined that this food enzyme does not raise safety concerns under the intended conditions of use. Since residual amounts of total organic solids (TOS) are removed during the food manufacturing process, toxicological studies other than allergenicity were deemed unnecessary, and dietary exposure was not calculated.

The EFSA's assessment highlights the importance of evaluating the potential allergenicity of food enzymes, even those produced from non-genetically modified organisms. By conducting a thorough safety review, the EU regulatory body ensures that new food ingredients are safe for consumers, including those with food allergies. This decision provides valuable insights for the food industry and regulatory authorities as they navigate the evolving landscape of food enzyme applications.