[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.838]
[Page 90-91]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 172_FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN
CONSUMPTION--Table of Contents
Subpart I_Multipurpose Additives
Sec. 172.838 Polysorbate 65.
The food additive polysorbate 65 (polyoxyethylene (20) sorbitan
[[Page 91]]
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:
(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 0.2 percent, which is then reacted with
ethylene oxide.
(b) The food additive meets the following specifications:
Saponification number 88-98.
Acid number 0-2.
Hydroxyl number 44-60.
Oxyethylene content 46 percent-50 percent.
(c) The additive is used, or intended for use, as follows:
(1) As an emulsifier in ice cream, frozen custard, ice milk, fruit
sherbet and nonstandardized frozen desserts when used alone or in
combination with polysorbate 80, whereby the maximum amount of the
additives, alone or in combination, does not exceed 0.1 percent of the
finished frozen dessert.
(2) As an emulsifier in cakes and cake mixes, with or without one or
a combination of the following:
(i) Sorbitan monostearate.
(ii) Polysorbate 60.
When used alone, the maximum amount of polysorbate 65 shall not exceed
0.32 percent of the cake or cake mix, on a dry-weight basis. When used
with sorbitan monostearate and/or polysorbate 60, it shall not exceed
0.32 percent, nor shall the sorbitan monostearate exceed 0.61 percent or
the polysorbate 60 exceed 0.46 percent, and no combination of these
emulsifiers shall exceed 0.66 percent of the cake or cake mix, all
calculated on a dry-weight basis.
(3) As an emulsifier in whipped edible oil topping with or without
one or a combination of the following:
(i) Sorbitan monostearate;
(ii) Polysorbate 60;
(iii) Polysorbate 80;
whereby the maximum amount of the additive or additives used does not
exceed 0.4 percent of the weight of the finished whipped edible oil
topping.
(4) 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) Sorbitan monostearate.
(ii) Polysorbate 60.
The maximum amount of the additive or additives shall not exceed 0.4
percent by weight of the finished edible vegetable fat-water emulsion.
(5) As an emulsifier in cake icings and cake fillings, with or
without one or a combination of the following:
(i) Sorbitan monostearate.
(ii) Polysorbate 60.
When used alone, the maximum amount of polysorbate 65 shall not exceed
0.32 percent of the weight of the cake icing or cake filling. When used
with sorbitan monostearate and/or polysorbate 60, it shall not exceed
0.32 percent, nor shall the sorbitan monostearate exceed 0.7 percent or
the polysorbate 60 exceed 0.46 percent, and no combination of these
emulsifiers shall exceed 1 percent of the weight of the cake icing or
cake filling.
(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) of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978]
Additives that reference this regulation: |
