§ 172.840 Polysorbate 80. - WestlawNext
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`§ 172.840 Polysorbate 80.
`Title 21. Food and Drugs (Approx. 7 pages)
`Code of Federal Regulations
`
`§ 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 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.
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`7/7/2015
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`HYDRITE EXHIBIT 1020
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`Code of Federal Regulations
`Title 21. Food and Drugs
`Chapter I. Food and Drug Administration, Department of Health and Human Services
`(Refs & Annos)
`Subchapter B. Food for Human Consumption
`Part 172. Food Additives Permitted for Direct Addition to Food for Human
`Consumption (Refs & Annos)
`Subpart I. Multipurpose Additives
`21 C.F.R. § 172.840
`Currentness
`

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`§ 172.840 Polysorbate 80. - WestlawNext
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`Page 2 of 3
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`(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.
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`(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;
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`(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 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 §§ 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.
`
`Credits
`[42 FR 14491, March 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978; 45 FR 58835,
`Sept. 5, 1980; 46 FR 8466, Jan. 27, 1981]
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`https://a.next.westlaw.com/Document/N2A8F0F608CDD11D9A785E455AAD0CC92/Vie...
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`7/7/2015
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`HYDRITE EXHIBIT 1020
`(2 OF 3)
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`§ 172.840 Polysorbate 80. - WestlawNext
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`Page 3 of 3
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`SOURCE: 42 FR 14491, March 15, 1977; 50 FR 32561, Aug. 13, 1985; 50 FR 42932, Oct.
`23, 1985; 54 FR 39634, Sept. 27, 1989; 58 FR 48598, Sept. 17, 1993; 58 FR 52221, Oct. 7,
`1993; 62 FR 51515, Oct. 1, 1997, unless otherwise noted.
`
`AUTHORITY: 21 U.S.C. 321, 341, 342, 348, 371, 379e.
`
`Current through June 25, 2015; 80 FR 36688.
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`End of Document
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`HYDRITE EXHIBIT 1020
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