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February 28, 2026EFSA Journal0 citationsOpen Access

Safety evaluation of the food enzyme serine endopeptidase from the genetically modified Aspergillus niger strain NZYM‐MG

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E(EFSA Panel on Food Enzymes (FEZ)HZHolger ZornJBJosé Manuel Barat Baviera

Key Points

  • The aim is to evaluate the safety of serine endopeptidase produced by modified Aspergillus niger for its intended food processing use.
  • Production of the enzyme from genetically modified Aspergillus niger strain NZYM-MG
  • Assessment of potential allergenicity through amino acid sequence comparison
  • Consideration of toxicological studies based on intended use
  • No viable cells or DNA from the production organism were present in the food enzyme
  • A match with one contact allergen was found, but allergic risk was excluded
  • The enzyme does not pose safety concerns under the intended conditions of use

Abstract

The food enzyme serine endopeptidase (EC 3.4.21) is produced with the genetically modified Aspergillus niger strain NZYM-MG by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in the processing of cereals and other grains for the production of distilled alcohol. Since residual amounts of food enzyme-total organic solids are removed in this process, toxicological studies were considered unnecessary by the Panel and a dietary exposure was not calculated. A search for the homology of the amino acid sequence of the serine endopeptidase to known allergens was made and a match with one contact allergen was found. The Panel considered that a risk of allergic reactions upon dietary exposure can be excluded for the production of distilled alcohol. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended condition of use.

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Cite This Study

(FEZ) et al. (2026) studied this question.

synapsesocial.com/papers/69a285aa0a974eb0d3c009d6https://doi.org/10.2903/j.efsa.2026.9959
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