EFSA Raises Neotame Safety Limit by 5 Times Confirms No Health Risks

On July 4, 2025, the European Food Safety Authority (EFSA) announced the results of its re-evaluation of neotame (E 961), a widely used artificial sweetener. The EFSA's Food Additives and Flavourings Panel (FAF) has increased the acceptable daily intake (ADI) from 2 mg/kg body weight (bw) per day to 10 mg/kg bw per day, based on updated toxicological data.

Neotame is a chemically synthesized compound with the main impurity NC-00751, which is also its primary metabolite. EFSA reviewed toxicological studies, including long-term carcinogenicity tests on rats, which showed no adverse effects at doses as high as 1,000 mg/kg bw per day. The panel confirmed that neotame is rapidly metabolized and excreted, with no evidence of genotoxicity or aneugenic effects at permitted levels.

Even at the revised ADI of 10 mg/kg bw per day, the exposure to methanol and its metabolite formaldehyde does not raise health concerns. Dietary exposure estimates across all population groups remain well within this limit, ensuring safety at current use levels.

EFSA recommended that the European Commission update the EU specifications for neotame (E 961) to reflect the latest findings. The re-evaluation confirms that neotame poses no safety concerns at authorized levels, providing reassurance for its continued use in the food industry.