EFSA Approves Cellulase from GM Aspergillus Niger with Low Allergy Risk
On 30 October 2025, the European Food Safety Authority issued a scientific opinion confirming that a cellulase enzyme produced by a genetically modified Aspergillus niger strain is safe under intended use conditions in three food manufacturing processes. EFSA determined that the genetic modification raises no safety concerns and that the enzyme is free from viable production organisms and DNA. Estimated dietary exposure reached up to 0.018 mg TOS/kg body weight per day, against a NOAEL of 1233 mg TOS/kg body weight per day, resulting in a margin of exposure considered sufficiently high. EFSA found no evidence of genotoxicity and no homology to known allergens, yet stated that while dietary allergy risk cannot be completely excluded, the likelihood is low. The enzyme was deemed to raise no safety concerns under the intended conditions of use.
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