[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: 21CFR172.840]
[Page 91-93]
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. 172.840 Polysorbate 80.
The food additive polysorbate 80 (polyoxyethylene (20) sorbitan
monooleate), which is a mixture of polyoxyethylene ethers of mixed
partial oleic 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 oleic acid
(usually containing associated fatty acids) with
[[Page 92]]
sorbitol to yield a product with a maximum acid number of 7.5 and a
maximum water content of 0.5 percent, which is then reacted with
ethylene oxide.
(b) The food additive meets the following specifications:
Saponification number 45-55.
Acid number 0-2.
Hydroxyl number 65-80.
Oxyethylene content 65 percent-69.5 percent.
(c) The additive is used or intended for use as follows:
(1) An emulsifier in ice cream, frozen custard, ice milk, fruit
sherbet, and nonstandardized frozen desserts, when used alone or in
combination with polysorbate 65 whereby the maximum amount of the
additives, alone or in combination, does not exceed 0.1 percent of the
finished frozen dessert.
(2) In yeast-defoamer formulations whereby the maximum amount of the
additive does not exceed 4 percent of the finished yeast defoamer and
the maximum amount of the additive in the yeast from such use does not
exceed 4 parts per million.
(3) As a solubilizing and dispersing agent in pickles and pickle
products, whereby the maximum amount of the additive does not exceed 500
parts per million.
(4) As a solubilizing and dispersing agent in:
(i) Vitamin-mineral preparations containing calcium caseinate in the
absence of fat-soluble vitamins, whereby the maximum intake of
polysorbate 80 shall not exceed 175 milligrams from the recommended
daily dose of the preparations.
(ii) Fat-soluble vitamins in vitamin and vitamin-mineral
preparations containing no calcium caseinate, whereby the maximum intake
of polysorbate 80 shall not exceed 300 milligrams from the recommended
daily dose of the preparations.
(iii) In vitamin-mineral preparations containing both calcium
caseinate and fat-soluble vitamins, whereby the maximum intake of
polysorbate 80 shall not exceed 475 milligrams from the recommended
daily dose of the preparations.
(5) As a surfactant in the production of coarse crystal sodium
chloride whereby the maximum amount of the additive in the finished
sodium chloride does not exceed 10 parts per million.
(6) In special dietary foods, as an emulsifier for edible fats and
oils, with directions for use which provide for the ingestion of not
more than 360 milligrams of polysorbate 80 per day.
(7) As a solubilizing and dispersing agent for dill oil in canned
spiced green beans, not to exceed 30 parts per million.
(8) As an emulsifier, alone or in combination with polysorbate 60,
in shortenings and edible oils intended for use in foods as follows,
when standards of identity established under section 401 of the act do
not preclude such use:
(i) It is used alone in an amount not to exceed 1 percent of the
weight of the finished shortening or oil.
(ii) It is used with polysorbate 60 in any combination providing no
more than 1 percent of polysorbate 80 and no more than 1 percent of
polysorbate 60, provided that the total combination does not exceed 1
percent of the finished shortening or oil.
(iii) The 1-percent limitation specified in paragraph (c)(8) (i) and
(ii) of this section may be exceeded in premix concentrates of
shortening or edible oil if the labeling complies with the requirements
of paragraph (d) of this section.
(9) 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 65;
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.
(10) It is used as a wetting agent in scald water for poultry
defeathering, followed by potable water rinse. The concentration of the
additive in the scald water does not exceed 0.0175 percent.
(11) As a dispersing agent in gelatin desserts and in gelatin
dessert mixes, whereby the amount of the additive does not exceed 0.082
percent on a dry-weight basis.
(12) As an adjuvant added to herbicide use and plant-growth
regulator use dilutions by a grower or applicator
[[Page 93]]
prior to application of such dilutions to the growing crop. Residues
resulting from such use are exempt from the requirement of a tolerance.
When so used or intended for use, the additive shall be exempt from the
requirements of paragraph (d)(1) of this section.
(13) As a defoaming agent in the preparation of the creaming mixture
for cottage cheese and lowfat cottage cheese, as identified in
Sec. Sec. 133.128 and 133.131 of this chapter, respectively, whereby
the amount of the additive does not exceed .008 percent by weight of the
finished products.
(14) As a surfactant and wetting agent for natural and artificial
colors for use in barbecue sauce where the level of the additive does
not exceed 0.005 percent by weight of the barbecue sauce.
(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; 45
FR 58835, Sept. 5, 1980; 46 FR 8466, Jan. 27, 1981]
Additives that reference this regulation: |
