# Polysorbate 65 — Food additive regulatory approval status — US FDA vs EU

For Polysorbate 65, jurisdiction is US FDA (21 CFR 172–178); status is permitted; citation is 21 CFR 172.838; 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 15 and a maximum water content of 0, recorded from its source on 2026-08-15.

- **Additive:** Polysorbate 65 _(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 172.838 _(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 15 and a maximum water content of 0.

## What the source says

> § 172.838 Polysorbate 65. The food additive polysorbate 65 (polyoxyethylene (20) sorbitan tristearate), which is a mixture of polyoxyethylene ethers of mixed stearic 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/).