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Dimethylpolysiloxane is permitted by the US FDA. Several countries restrict, warning-label, or have reviewed it for safety concerns. The US has more lenient additive rules than the EU, UK, Canada, and Japan, which is why this ingredient remains widely used here.
Dimethylpolysiloxane is generally considered non-toxic. It is not absorbed by the gut and passes through the digestive system unchanged. The FDA permits it at up to 10 ppm in cooking oils. EFSA's evaluation found no evidence of toxicity at permitted food use levels. There are no established cancer or reproductive toxicity concerns with PDMS at food use concentrations. The compound is the same base polymer used in many safe medical applications including contact lenses and breast implants (though the medical grade is different purity). The main environmental concern is PDMS persistence in the environment, as it is not readily biodegradable. Primary consumer concern is psychological rather than toxicological: the fact that it is used in both McDonald's frying oil and Silly Putty (which also contains PDMS) generates public attention, but the chemistries are actually different grades of the same polymer family.
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