A high-intensity artificial sweetener, structurally related to aspartame but far more potent, used in small amounts to add sweetness without calories.
What is it?
Neotame is a synthetic dipeptide sweetener made by adding a 3,3-dimethylbutyl group to the same amino-acid backbone as aspartame (aspartic acid and phenylalanine methyl ester). That modification makes it around 7,000 to 13,000 times sweeter than sugar and dramatically reduces the amount of phenylalanine the body is exposed to after digestion, distinguishing it from aspartame.
What does it do?
It binds to sweet taste receptors on the tongue far more strongly than sugar, producing an intense sweet sensation at concentrations too small to contribute meaningful calories or carbohydrates. Because so little is needed, it replaces large amounts of sugar or other sweeteners in a product.
Where you will see it
Neotame is approved for use in a wide range of foods including soft drinks, dairy-based desserts, chewing gum, confectionery, baked goods, jams, sauces, tabletop sweeteners, and certain dietetic foods. It is rare in UK products compared with aspartame or acesulfame K. On a label it appears as 'neotame' or 'E961', typically listed in the ingredients under 'sweeteners'.
What the science says
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.
Dietary exposure estimates for neotame across all population groups and scenarios did not exceed the revised ADI of 10 mg/kg bodyweight per day.
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.
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.
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.
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.
Where it stands with the regulators
Who should be careful
People with phenylketonuria (PKU) should be aware neotame is a structural relative of aspartame, but current regulatory assessment holds that phenylalanine released at food-use levels is negligible and no PKU warning label is required. Individuals managing PKU strictly should check with their metabolic dietitian. Look for 'neotame' or 'E961' in the ingredients list under 'sweeteners'.
The honest read
Neotame is one of the least commonly used approved sweeteners in the UK food supply, so exposure for most people is very low. The 2025 EFSA re-evaluation, which was the most detailed review of the evidence to date, found no concerns at the use levels permitted. The ADI was actually raised, not lowered, after more data were considered. Gut microbiome research on high-intensity sweeteners is active but has not produced consistent findings at realistic intake levels, and the evidence base for neotame specifically is thinner than for more widely used sweeteners such as aspartame or sucralose. The honest position is that the science reviewed so far does not flag a problem, but the additive is not widely enough used for large human observational studies to exist.
Related additives
Common questions
Is E961 banned in the UK?
No. Neotame is an approved food additive in the UK and EU, permitted in a range of food categories under the UK FSA approved-additives list and assimilated EU Regulation 1333/2008.
Is E961 the same as aspartame, and does it need a PKU warning?
Neotame is structurally related to aspartame and releases a small amount of phenylalanine when digested. However, the quantity released at any realistic food intake is tiny, and UK and EU law do not require a 'contains a source of phenylalanine' warning on products containing neotame, unlike aspartame. People with phenylketonuria who follow a strict low-phenylalanine diet should check with their dietitian.
What foods contain E961?
Neotame is approved for soft drinks, dairy desserts, confectionery, chewing gum, baked goods, jams, sauces, and tabletop sweeteners, among other categories. It is rarely found in UK products because manufacturers tend to use more established sweeteners such as aspartame, acesulfame K, or sucralose. Check the ingredients list for 'neotame' or 'E961' under 'sweeteners'.
Is E961 vegan?
Yes. Neotame is a synthetically manufactured compound and contains no animal-derived ingredients. It is suitable for vegans and vegetarians.
Sources
- Re-evaluation of neotame (E961) as food additive, EFSA Journal 2025
- Approved additives and E numbers, UK Food Standards Agency
- Re-evaluation of neotame (E961) as food additive, PubMed
- EFSA reaffirms the safety of Neotame, International Sweeteners Association
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