Polysorbate 65 (E436): What the Sources Found

Polysorbate 65 is the emulsifier the food industry lists as E436. 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.
Flagged for young children. Set only where EFSA’s own exposure assessment shows toddlers or children exceeding or approaching the ADI, or where a regulator used explicitly child-specific language. For a child under 6 it moves one class up.
4 citations from EFSA, Peer-reviewed, FDA, each one below.

What Polysorbate 65 does to a score

A packaged food starts with 33 points for what is in its ingredient list. Polysorbate 65 takes 6 of the 33 additive points off a product's score, and a child under 6 sees it one class higher again. 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 10.2903/j.efsa.2015.4152
Re-evaluation of polysorbates E 432–E 436 (E 436 = polyoxyethylene sorbitan tristearate): group ADI of 25 mg/kg bw per day from JECFA retained; refined non-brand-loyal exposure did not exceed the ADI for any age group at mean or high level, but 'the estimated exposure of toddlers at the highest level in a non-brand loyal scenario remains very close to the ADI (24.5 mg/kg bw/day)'.
EFSA 10.2903/j.efsa.2015.4152 (data-gap conclusion)
No reported uses were obtained for three food categories and other dietary sources of polysorbate exposure could not be considered; more data are needed to reduce uncertainty in the refined exposure assessment.
Peer-reviewed PMID 25731162 - Chassaing B et al., Nature 2015;519:92-96
Polysorbate-80 (same E 432–E 436 group) and CMC at low concentrations induced low-grade inflammation and metabolic syndrome in wild-type mice and robust colitis in colitis-prone mice, with reduced mucus thickness and increased bacterial encroachment.
FDA 21 CFR §172.838 (polysorbate 65)
Permitted as an emulsifier in ice cream, frozen custard, ice milk, fruit sherbet and non-standardised frozen desserts (≤0.1% alone or with polysorbate 80); cakes and cake mixes; whipped edible oil topping; edible vegetable fat-water emulsions used as milk/cream substitutes in beverage coffee; and cake icings and fillings.

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 high. 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.