The European Food Safety Authority (EFSA) has assessed the safety of the food enzyme inulinase, produced using the non-genetically modified Aspergillus niger strain NZYM-KF by Novozymes A/S. The enzyme is intended for use in the production of fructo-oligosaccharides from fructo-polysaccharides.

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Background and Regulatory Framework

According to Article 3 of Regulation (EC) No 1332/2008, a 'food enzyme' is defined as a product obtained from plants, animals, or microorganisms, capable of catalyzing specific biochemical reactions and added to food for technological purposes. Food enzyme preparations may include additives and other ingredients to facilitate their use and storage.

Before 2009, food enzymes were regulated under Member State laws. On January 20, 2009, Regulation (EC) No 1332/2008 established the rules for food enzymes, mandating safety evaluations by EFSA for all enzymes to be used within the European Union. This regulation ensures that food enzymes do not pose health risks, fulfill technological needs, and do not mislead consumers.

Safety Evaluation of Inulinase

The EFSA Panel reviewed the safety of inulinase from Aspergillus niger strain NZYM-KF. Toxicological studies, except for allergenicity, were deemed unnecessary as residual organic solids are removed during food processing. A search for amino acid sequence similarities with known allergens revealed two matches with tomato allergens. The Panel concluded that while allergic reactions to this enzyme, especially in individuals sensitized to tomatoes, cannot be excluded, the risk is low due to the overall low prevalence of tomato allergies.

"The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to tomato, cannot be excluded, but is expected not to exceed that of tomato."

Regulatory Approval Process

Under Regulation (EC) No 1332/2008, only food enzymes included in the EU Community list can be marketed and used in foods. The European Commission has validated five applications, including the inulinase enzyme, confirming they meet the regulatory requirements for safety assessment and approval.

"The European Commission requests the European Food Safety Authority to carry out the safety assessments of the food enzymes... in accordance with Article 17.3 of Regulation (EC) No 1332/2008 on food enzymes."

Conclusion

Based on the data provided, EFSA concluded that the inulinase enzyme from Aspergillus niger strain NZYM-KF does not pose safety concerns under the intended conditions of use.

Highlights

• EFSA assessed the safety of inulinase from Aspergillus niger strain NZYM-KF.
• The enzyme is intended for fructo-oligosaccharides production.
• Toxicological studies were unnecessary due to the removal of residual organic solids.
• Low risk of allergic reactions, similar to tomato allergens, was identified.
• EFSA concluded no safety concerns for the enzyme under intended use.

Data Source: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2024.8771