Reviewers could not rule out DNA damage for lack of data
When European reviewers looked at the polysorbates (E432 to E436) in 2015, they found the data were not enough to rule out DNA damage. They kept the existing daily limit but asked for new studies to fill the gap. That is a formal warning flag, not a finding that it damages DNA, but it means the question has not been answered to the regulator's satisfaction.
Reviewers found too little data on DNA damage for the polysorbates (E432 to E436) and called for new studies before the gap could be closed.
2015Regulator reviewEFSA ANS Panel, re-evaluation of polysorbates (E432-436)
A related polysorbate disturbed gut bacteria in mice
Most of the research on emulsifiers and the gut has looked at polysorbate 80 (E433) and cellulose gum, not polysorbate 60. In mice and in lab models of the gut, polysorbate 80 at higher doses changed the mix of gut bacteria and made the gut wall leakier, in ways linked to low-level inflammation. Because polysorbate 60 has the same backbone and is regulated in the same group, these findings are seen as relevant, but there is little direct evidence in people for polysorbate 60 itself.
Polysorbate 80 and cellulose gum (carboxymethylcellulose) disturbed gut bacteria and encouraged gut inflammation in mice, at doses above typical intake.
2015Animal studyChassaing et al., Nature
In a lab model of the gut, rising amounts of polysorbate 80 and cellulose gum changed the mix of gut bacteria and damaged the gut lining, more so at higher doses.
Lab studyScienceDirect / Microbiome journal studies (various, 2020-2025)
The daily limit rests on incomplete evidence
The international expert committee set a shared daily limit of 25mg per kg of body weight for the polysorbates, and European reviewers adopted it. Estimated intakes in Europe are generally well below it, but because of the gap on DNA damage, the limit itself rests on incomplete evidence.
The international committee set a shared daily limit of 25mg per kg of body weight for polysorbates, which European reviewers adopted for E432 to E436.
2015Regulator reviewJECFA; EFSA ANS Panel re-evaluation