Simethicone
Simethicone is permitted as a defoaming agent in food processing under 21 CFR 173.340 with strict use limits (10 ppm in most foods). It is non-absorbed by the gastrointestinal tract and is widely used as an OTC anti-gas medication, including infant formulations.
What it is
A mixture of polydimethylsiloxane (dimethicone) and silicon dioxide; an anti-foaming agent.
Defoaming agent used during food processing to inhibit foaming; also widely used as an OTC anti-gas medication.
Why it's flagged
- use limits in food processing must be observed
What regulators actually say
"Defoaming agents may be safely used in processing foods... Defoaming agents must be added in an amount not in excess of that reasonably required to inhibit foaming."
"Dimethylpolysiloxane (substantially free from hydrolyzable chloride and alkoxy groups) with specific usage limits of 10 parts per million in food."
Regulatory status
United States — FDA
Permitted defoaming agent in food processing under 21 CFR 173.340; also approved OTC drug ingredient.
European Union — EFSA
Permitted in EU food applications.
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