# Polysorbate 60 — Food additive regulatory approval status — US FDA vs EU

For Polysorbate 60, jurisdiction is US FDA (21 CFR 172–178); status is permitted; citation is 21 CFR 172.836; use conditions is in food in accordance with the following prescribed conditions:   ( a ) The food additive is manufactured by reacting stearic acid (usually containing associated fatty acids, chiefly palmitic) with sorbitol to yield a product with a maximum acid number of 10 and a maximum water content of 0, recorded from its source on 2026-08-15.

- **Additive:** Polysorbate 60 _(verified: appears in the quote below)_
- **Jurisdiction:** US FDA (21 CFR 172–178) _(our reading, not quoted from the source)_
- **Status:** permitted _(our reading, not quoted from the source)_
- **Citation:** 21 CFR 172.836 _(our reading, not quoted from the source)_
- **Use conditions:** in food in accordance with the following prescribed conditions:   ( a ) The food additive is manufactured by reacting stearic acid (usually containing associated fatty acids, chiefly palmitic) with sorbitol to yield a product with a maximum acid number of 10 and a maximum water content of 0.

## What the source says

> § 172.836 Polysorbate 60. The food additive polysorbate 60 (polyoxyethylene (20) sorbitan monostearate) which is a mixture of polyoxyethylene ethers of mixed partial stearic and palmitic acid esters of sorbitol anhydrides and related compounds, may be safely used in food in accordance with the following prescribed conditions:

## Source

- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-172

Last verified: 2026-08-15. Review by: 2027-08-15.
Part of [Food additive regulatory approval status — US FDA vs EU](https://referencesource.org/food-additive-approval-status-us-vs-eu/).