CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 3]

[CITE: 21CFR172.818]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 172 -- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

Subpart I - Multipurpose Additives

Sec. 172.818 Oxystearin.

The food additive oxystearin may be safely used in foods, when such use is not precluded by standards of identity in accordance with the following conditions:

(a) The additive is a mixture of the glycerides of partially oxidized stearic and other fatty acids obtained by heating hydrogenated cottonseed or soybean oil under controlled conditions, in the presence of air and a suitable catalyst which is not a food additive as so defined. The resultant product meets the following specifications:

Acid number: Maximum 15.

Iodine number: Maximum 15.

Saponification number: 225-240.

Hydroxyl number: 30-45.

Unsaponifiable material: Maximum 0.8 percent.

Refractive index (butyro): 60+/-1 at 48 deg.C.

(b) It is used or intended for use as a crystallization inhibitor in vegetable oils and as a release agent in vegetable oils and vegetable shortenings, whereby the additive does not exceed 0.125 percent of the combined weight of the oil or shortening.

(c) To insure safe use of the additive, the label and labeling of the additive container shall bear, in addition to the other information required by the Act:

(1) The name of the additive.

(2) Adequate directions to provide an oil or shortening that complies with the limitations prescribed in paragraph (b) of this section.