Neotame (E961): What the Sources Found

Neotame is the sweetener the food industry lists as E961. In our table it is low risk: it takes 6 of the 33 additive points off a product's score for a child.

In short

Low risk. 6 of the 33 additive points come off a product that carries it.
No child flag. Nothing below is written about children specifically, so the class is the same at every age.
3 citations from EFSA, Peer-reviewed, FDA, each one below.

What Neotame does to a score

A packaged food starts with 33 points for what is in its ingredient list. Neotame takes 6 of the 33 additive points off a product's score. Scan the pack in Sito and the score you get is the one for your own child's age, with this additive named in the reasons. How we score has the whole method.

What the sources found

Every classification in our table comes from the citations below, and nothing else. They are quoted as the source wrote them.

EFSA Journal 2025;23(7):9480, doi:10.2903/j.efsa.2025.9480 (PMC12231243)
Re-evaluation set an ADI of 10 mg/kg bw/day (NOAEL 1,000 mg/kg bw/day from combined chronic/carcinogenicity rat studies, UF 100), found no concern for genotoxicity at permitted levels, and reported toddler exposure at most 0.16 mg/kg bw/day at P95 and children at most 0.01 mg/kg bw/day — far below the ADI; no safety concern at permitted uses.
Peer-reviewed Shil A, Ladeira Faria LM, Walker CA, Chichger H. 2024, Front Nutr 11:1366409, doi:10.3389/fnut.2024.1366409 (PMID 38721028)
At physiologically relevant concentrations neotame caused intestinal epithelial (Caco-2) apoptosis via T1R3 signalling and induced pathogenic changes in model gut bacteria (E. coli, E. faecalis) including breakdown of the epithelial barrier — in vitro only, not reflected in any regulatory status.
FDA High-Intensity Sweeteners (fda.gov/food/food-additives-petitions/high-intensity-sweeteners)
Neotame is one of six high-intensity sweeteners approved by FDA as a food additive, with an ADI set at pre-market review.

Why this class

A credible adverse or precautionary signal that stops short of every Moderate and High criterion: peer-reviewed adverse findings not yet reflected in regulatory status, an exposure exceedance confined to high-percentile or single-event estimates, or a precautionary regulatory step short of those criteria — a reduced ADI, a data limitation noted without an adverse conclusion, a narrowed or conditioned authorisation, or a child-focused assessment or school-food law that covers the additive as part of a class.

Our confidence in this row's classification is medium. Medium or low does not mean the evidence is weak; it means something about the row is still being pinned down, usually a regulatory status confirmed from one source rather than two.