---
kind: "section"
citation: "21 C.F.R. § 172.842"
title: "21"
number: "172.842"
heading: "Sorbitan monostearate."
url: "https://uscodex.org/cfr/21/172.842"
---

# §172.842. Sorbitan monostearate.


The food additive sorbitan monostearate, which is a mixture of partial stearic and palmitic acid esters of sorbitol anhydrides, may be safely used in or on 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 essentially a mixture of esters.
- (b) **The food additive meets the following specifications—**
- (c) **It is used or intended for use, alone or in combination with polysorbate 60 as follows—**
  - (1) **As an emulsifier in whipped edible oil topping with or without one or a combination of the following—**
    - (i) Polysorbate 60;
    - (ii) Polysorbate 65;
    - (iii) Polysorbate 80;
  - (2) **As an emulsifier in cakes and cake mixes, with or without one or a combination of the following—**
    - (i) **Polysorbate 65.**
    - (ii) **Polysorbate 60.**
  - (3) As an emulsifier, alone or in combination with polysorbate 60 in nonstandardized confectionery coatings and standardized cacao products specified in §§ [163.123](/cfr/21/163.123.md), [163.130](/cfr/21/163.130.md), [163.135](/cfr/21/163.135.md), [163.140](/cfr/21/163.140.md), [163.145](/cfr/21/163.145.md), and [163.150](/cfr/21/163.150.md) of this chapter, as follows:
    - (i) It is used alone in an amount not to exceed 1 percent of the weight of the finished nonstandardized confectionery coating or standardized cacao product.
    - (ii) It is used with polysorbate 60 in any combination of up to 1 percent sorbitan monostearate and up to 0.5 percent polysorbate 60 provided that the total combination does not exceed 1 percent of the weight of the finished nonstandardized confectionery coating or standardized cacao product.
  - (4) As an emulsifier in cake icings and cake fillings, with or without one or a combination of the following:
    - (i) **Polysorbate 65.**
    - (ii) **Polysorbate 60.**
  - (5) As an emulsifier in solid-state, edible vegetable fat-water emulsions intended for use as substitutes for milk or cream in beverage coffee, with or without one or a combination of the following:
    - (i) **Polysorbate 60.**
    - (ii) **Polysorbate 65.**
  - (6) It is used alone as a rehydration aid in the production of active dry yeast in an amount not to exceed 1 percent by weight of the dry yeast.
  - (7) As an emulsifier, alone or in combination with polysorbate 60, in the minimum quantity required to accomplish the intended effect, in formulations of white mineral oil conforming with [§ 172.878](/cfr/21/172.878.md) and/or petroleum wax conforming with [§ 172.886](/cfr/21/172.886.md) for use as protective coatings on raw fruits and vegetables.
- (d) **To assure safe use of the additive, in addition to the other information required by the Act—**
  - (1) The label of the additive and any intermediate premixes shall bear:
    - (i) **The name of the additive.**
    - (ii) **A statement of the concentration or strength of the additive in any intermediate premixes.**
  - (2) The label or labeling shall bear adequate directions to provide a final product that complies with the limitations prescribed in [paragraph (c)](#c) of this section.

## Notes

### Amendments

[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978]

### Authority

Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.

### Source

Source: 42 FR 14491, Mar. 15, 1977, unless otherwise noted.

### Amendments

[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978]