Polysorbate 60 (E435)

Polysorbate 60 is the emulsifier the food industry lists as E435. In our table it is low risk: it takes 6 points off the additive subscore (about 2 of the 100).

What Polysorbate 60 does to a score

A packaged food's additive subscore starts at 100 and loses points for each additive on the label; that subscore is a third of the final score. Polysorbate 60 takes 6 points off the additive subscore (about 2 of the 100), 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. Each finding is our one-line summary of what the source concluded, with the source and reference beside it.

• EFSA 10.2903/j.efsa.2015.4152
  Re-evaluation of polysorbates E 432-E 436: group ADI of 25 mg/kg bw per day (from JECFA) retained; in the refined non-brand-loyal scenario 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)
  Panel noted no reported uses were obtained for three food categories and that other dietary sources of polysorbate exposure could not be considered, so 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, obesity/metabolic syndrome in wild-type mice and robust colitis in colitis-prone mice, with reduced mucus thickness and increased bacterial encroachment.

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.

Questions parents ask

Is Polysorbate 60 (E435) safe for kids?

Low risk. In Sito it takes 6 points off the additive subscore (about 2 of the 100). It is flagged for young children, so for a child under 6 it moves up one class, to moderate risk: 15 points off the additive subscore. The finding we rely on: Re-evaluation of polysorbates E 432-E 436: group ADI of 25 mg/kg bw per day (from JECFA) retained; in the refined non-brand-loyal scenario 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).

What is E435?

E435 is the E number for Polysorbate 60, an emulsifier. Open Food Facts tags it en:e435.

Next to it on the label

The E numbers either side of E435 in our table, then the closest emulsifiers by number.

• Polyoxyethylene (40) stearate (E431), no risk identified
• Polysorbate 20 (E432), low risk, flagged for young children
• Polysorbate 80 (E433), low risk, flagged for young children
• Polysorbate 40 (E434), low risk, flagged for young children
• Polysorbate 65 (E436), low risk, flagged for young children
• Ammonium phosphatides (E442), no risk identified