The European Food Safety Authority (EFSA) has delivered a comprehensive safety evaluation of the food enzyme aspergillopepsin I, produced by the non‐genetically modified Aspergillus niger strain CCTCC M 2023234. Released on 22 January 2026, this assessment will undoubtedly reverberate through food manufacturers, safety regulators, and consumers alike — raising attention on food enzyme safety standards, manufacturing practices, and labeling transparency.
This scientific opinion, crafted by EFSA's specialized unit on food enzymes, is the result of rigorous examination and was adopted on 9 December 2025. The document is an authoritative scientific opinion rather than new legislation, intended to inform regulatory decisions without imposing immediate mandatory changes.
The opinion provides detailed toxicological analysis including a no observed adverse effect level (NOAEL) derived from a 90-day repeated dose oral toxicity study in rats, setting a safety threshold at 2000 mg total organic solids (TOS) per kg body weight per day, with dietary exposure estimated up to 6.664 mg TOS/kg bw/day in Europeans. Genotoxicity concerns were ruled out, though some homology with known allergens was noted, leading EFSA to flag a low but non-negligible risk of allergic reactions.
Policy-wise, EFSA confirms the enzyme’s safe use in seven of eight food manufacturing processes, identifying a margin of exposure of at least 300, sufficient under their assessment to approve its continued use. The report emphasises consumer safety and cautious allergen risk management while implicitly encouraging industry to adhere closely to intended uses and exposure limits.
Stakeholders impacted include food manufacturers who must ensure compliance with usage conditions and potentially monitor allergen-related disclosures; EU regulatory bodies that may leverage this evaluation in setting or updating food enzyme standards; consumers reassured by documented safety levels but informed of possible allergenicity; and civil society organizations attentive to transparent risk communication.
This safety evaluation marks a critical piece of EFSA's ongoing scientific framework for food enzyme regulation, anticipated to guide future decisions by national authorities and inform industry practices. While not the end of regulatory processes, it acts as a keystone scientific reference, paving the way for subsequent institutional reactions and possible updates in food safety standards across the EU.
← Atlas › News › Agri-Food