2025 EFSA re-evaluation: ADI raised fivefold
In 2025, EFSA's food additives panel completed a full re-evaluation of neotame drawing on chronic toxicity, carcinogenicity, genotoxicity, and reproductive studies. The panel raised the acceptable daily intake from 2 mg/kg bodyweight per day (set in 2007) to 10 mg/kg bodyweight per day, reflecting a better-characterised no-adverse-effect level in long-term rat studies. The panel concluded that estimated dietary exposure across all population groups did not approach the new ADI.
EFSA established an ADI of 10 mg/kg bodyweight per day based on a no-observed-adverse-effect level of 1,000 mg/kg bodyweight per day from 52-week and 104-week rat studies, replacing the 2007 ADI of 2 mg/kg bodyweight per day.
2025Regulatory reviewEFSA Panel on Food Additives and Flavourings, EFSA Journal
Dietary exposure estimates for neotame across all population groups and scenarios did not exceed the revised ADI of 10 mg/kg bodyweight per day.
2025Regulatory reviewEFSA Panel on Food Additives and Flavourings, EFSA Journal
Genotoxicity: no concern at food-use levels
In vitro tests showed some potential for aneugenicity (an ability to disrupt chromosome segregation) at very high concentrations. The EFSA panel assessed these findings and concluded the effect would not occur at the concentrations the body encounters from food use. No concern for genotoxicity was identified at permitted or reported use levels.
While some in vitro assays indicated possible aneugenicity, the panel concluded that aneugenic effects at sites of contact were not expected under conditions of intended use, and there is no genotoxicity concern at maximum permitted or reported use levels.
2025Regulatory reviewEFSA Panel on Food Additives and Flavourings, EFSA Journal
Phenylalanine and phenylketonuria
Neotame is metabolised to release a small amount of phenylalanine, the amino acid that people with phenylketonuria (PKU) must restrict. However, the amount released at any realistic intake is so small that the 2025 EFSA panel calculated it would raise blood phenylalanine by less than 1% even in people who carry one copy of the PKU gene. Unlike aspartame, neotame does not carry a mandatory 'contains a source of phenylalanine' warning under UK or EU food information law.
The phenylalanine potentially formed from neotame at the ADI of 10 mg/kg bodyweight per day would increase physiological phenylalanine concentration by less than 1%, which the panel considered acceptable even for individuals heterozygous for the phenylalanine hydroxylase gene.
2025Regulatory reviewEFSA Panel on Food Additives and Flavourings, EFSA Journal
Reproductive and developmental studies
Three reproductive and developmental toxicity studies in animals showed no adverse effects. The panel found no signals of concern in this area.
Three reproductive and developmental toxicity studies found no adverse effects attributable to neotame.
2025AnimalEFSA Panel on Food Additives and Flavourings, EFSA Journal
Gut microbiome: limited evidence
A small number of in vitro and animal studies have examined whether high-intensity sweeteners including neotame alter gut bacteria. Results are limited and inconsistent. No robust human evidence exists that food-level intakes of neotame meaningfully alter the gut microbiome.
Studies on gut microbiome effects of high-intensity sweeteners are largely in vitro or animal-based and have not produced consistent findings at realistic human exposure levels.
2025Lab + animalVarious, reviewed in EFSA 2025 re-evaluation