Zinc Stearate
Zinc stearate is generally considered low-toxicity by ingestion at the small amounts used in tablets. Inhalation of the powder is hazardous (aspiration pneumonia, especially in infants from baby powders).
What it is
Zinc salt of stearic acid; a white, water-insoluble metallic soap.
Not authorised as a direct food additive in EU food law. In the US, used as an anticaking and release agent in tablet manufacture and dietary supplements; permitted as a component of food-contact polymers under 21 CFR.
Why it's flagged
- aspiration/inhalation risk
- not authorised as direct food additive in EU
What regulators actually say
"The lubricants listed in paragraph (b) of this section may be safely used as components of nonfood articles intended for use in contact with food... zinc stearate."
Regulatory status
United States — FDA
Permitted in food-contact substances under 21 CFR 175.300, 178.3570, 178.3910; widely used as a tablet/excipient in supplements
European Union — EFSA
Not authorised as a direct food additive under Regulation (EC) 1333/2008
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