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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2017.

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2017]
[CITE: 21CFR172]





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

Subpart C--Coatings, Films and Related Substances

Sec. 172.210 Coatings on fresh citrus fruit.

Coatings may be applied to fresh citrus fruit for protection of the fruit in accordance with the following conditions:

(a) The coating is applied in the minimum amount required to accomplish the intended effect.

(b) The coating may be formulated from the following components, each used in the minimum quantity required to accomplish the intended effect:

(1) Substances generally recognized as safe for the purpose or previously sanctioned for the purpose.

(2) One or more of the following:

Component Limitations
Fatty acidsComplying with 172.860.
Oleic acid derived from tall oil fatty acidsComplying with 172.862.
Partially hydrogenated rosinCatalytically hydrogenated to a maximum refractive index of 1.5012 at 100 deg. C. Color of WG or paler.
Pentaerythritol ester of maleic anhydride-modified wood rosinAcid number of 134-145; drop-softening point of 127 deg. C-173 deg. C; saponification number of less than 280; and a color of M or paler.
DoAcid number of 176-186; drop-softening point of 110 deg. C-118 deg. C; saponification number of less than 280; and a color of M or paler.
Polyethylene glycolComplying with 172.820. As a defoamer and dispersing adjuvant.
Polyhydric alcohol diesters of oxidatively refined (Gersthofen process) montan wax acidsComplying with 178.3770 of this chapter and having a dropping point of 77 to 83 deg. C (170.6 to 181.4 deg. F), as determined by ASTM Method D566-76 (Reapproved 1982), "Standard Test Method for Dropping Point of Lubricating Grease," which is incorporated by reference (Copies are available from the American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.) using as a solvent xylene-ethyl alcohol in a 2:1 ratio instead of toluene-ethyl alcohol in a 2:1 ratio.
Sodium lauryl sulfateComplying with 172.822. As a film former.
Wood rosinColor of K or paler.

(3) In lieu of the components listed in paragraph (b) (2) and (4) of this section, the following copolymer and one or more of the listed adjuvants.

Component Limitations
Vinyl chloride-vinylidene chloride copolymerAs an aqueous dispersion containing a minimum of 75 percent water when applied.
Polyethylene glycolComplying with 172.820. As a defoamer and dispersing adjuvant.
PolyvinylpyrrolidoneAs an adjuvant.
Potassium persulfate Do.
Propylene glycol alginate Do.
Sodium decylbenzenesulfonate Do.

(4) In lieu of the components listed in paragraph (b) (2) and (3) of this section, the following rosin derivative and either or both of the listed adjuvants:

Component Limitations
Calcium salt of partially dimerized rosinHaving a maximum drop-softening point of 197 deg. C and a color of H or paler. It is prepared by reaction with not more than 7 parts hydrated lime per 100 parts of partially dimerized rosin. The partially dimerized rosin is rosin that has been dimerized by sulfuric acid catalyst to a drop-softening point of 95 deg. C to 105 deg. C and a color of WG or paler.
Petroleum naphthaAs adjuvant. Complying with 172.250.
Sperm oilAs adjuvant.

[42 FR 14491, Mar. 15, 1977; 49 FR 5747, Feb. 15, 1984, as amended at 51 FR 2693, Jan. 21, 1986; 52 FR 18911, May 20, 1987; 61 FR 14245, Apr. 1, 1996]

Sec. 172.215 Coumarone-indene resin.

The food additive coumarone-indene resin may be safely used on grapefruit, lemons, limes, oranges, tangelos, and tangerines in accordance with the following prescribed conditions:

(a) The food additive is manufactured by the polymerization of a crude, heavy coal-tar solvent naphtha meeting the following specifications:

(1) It is a mixture of indene, indan (hydrindene), substituted benzenes, and related compounds.

(2) It contains no more than 0.25 percent tar bases.

(3) 95 percent distills in the range 167 deg. C-184 deg. C.

(b) The food additive meets the following specifications:

(1) Softening point, ring and ball: 126 deg. C minimum as determined by ASTM method E28-67 (Reapproved 1982), "Standard Test Method for Softening Point by Ring-and-Ball Apparatus," which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(2) Refractive index (n 25/D ) 1.63-1.64.

(c) It is used or intended for use as a protective coating for grapefruit, lemons, limes, oranges, tangelos, and tangerines whereby the maximum amount of the resin remaining on the fruit does not exceed 200 parts per million on a fresh-weight basis.

(d) To assure safe use of the additive:

(1) The label of the market package or any intermediate premix of the additive shall bear, in addition to the other information required by the act:

(i) The name of the additive, coumarone-indene resin.

(ii) A statement of the concentration of the additive therein.

(2) The label or accompanying labeling shall bear adequate directions that, if followed, will result in a finished food not in conflict with the requirements of this section.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10103, Mar. 19, 1984]

Sec. 172.225 Methyl and ethyl esters of fatty acids produced from edible fats and oils.

Methyl esters and ethyl esters of fatty acids produced from edible fats and oils may be safely used in food, subject to the following prescribed conditions:

(a) The additive consists of a mixture of either methyl or ethyl esters of fatty acids produced from edible fats and oils and meets the following specifications:

(1) Not less than 90 percent methyl or ethyl esters of fatty acids.

(2) Not more than 1.5 percent unsaponifiable matter.

(b) The additive is used or intended for use at the level not to exceed 3 percent by weight in an aqueous emulsion in dehydrating grapes to produce raisins, whereby the residue of the additive on the raisins does not exceed 200 parts per million.

[57 FR 12711, Apr. 13, 1992]

Sec. 172.230 Microcapsules for flavoring substances.

Microcapsules may be safely used for encapsulating discrete particles of flavoring substances that are generally recognized as safe for their intended use or are regulated under this part, in accordance with the following conditions:

(a) The microcapsules may be formulated from the following components, each used in the minimum quantity required to accomplish the intended effect:

(1) Substances generally recognized as safe for the purpose.

(2) One or more of the following components:

component and limitations

Succinylated gelatin--Not to exceed 15 percent by combined weight of the microcapsule and flavoring oil. Succinic acid content of the gelatin is 4.5 to 5.5 percent.

Arabinogalactan--Complying with 172.610; as adjuvant.

Silicon dioxide--Complying with 172.480; as adjuvant.

(3) In lieu of the components listed in paragraph (a)(2) of this section, the following components:

component and limitations

Glutaraldehyde--As cross-linking agent for insolubilizing a coacervate of gum arabic and gelatin.

n -Octyl alcohol--As a defoamer.

(4) In lieu of the components listed in paragraphs (a)(2) and (3) of this section, the following component:

component and limitations

Petroleum wax--Complying with 172.886. Not to exceed 50 percent by combined weight of the microcapsule and spice-flavoring substance.

(b) The microcapsules produced from the components listed in paragraphs (a) (1), (2), and (3) of this section may be used for encapsulating authorized flavoring oils for use, in accordance with good manufacturing practice, in foods for which standards of identity established under section 401 of the Act do not preclude such use, except that microcapsules formulated from components listed in paragraph (a)(2) of this section may be used only for encapsulating lemon oil, distilled lime oil, orange oil, peppermint oil, and spearmint oil for use in dry mixes for puddings and gelatin desserts.

(c) The microcapsules produced from the components listed in paragraphs (a) (1) and (4) of this section may be used only for encapsulating authorized spice-flavoring substances for use, in accordance with good manufacturing practice, in frozen pizzas which are to be further processed by heat. Such pizzas shall bear labels or labeling including adequate directions for use to ensure heating to temperatures which will melt the wax to release the spice-flavoring substances.

[45 FR 48123, July 18, 1980]

Sec. 172.235 Morpholine.

Morpholine may be safely used as a component of food, subject to the following restrictions.

(a) It is used as the salt(s) of one or more of the fatty acids meeting the requirements of 172.860, as a component of protective coatings applied to fresh fruits and vegetables.

(b) It is used at a level not in excess of that reasonably required to produce its intended effect.

Sec. 172.250 Petroleum naphtha.

Petroleum naphtha may be safely used in food in accordance with the following conditions:

(a) The additive is a mixture of liquid hydrocarbons, essentially paraffinic and naphthenic in nature obtained from petroleum,

(b) The additive is refined to meet the following specifications when subjected to the procedures described in this paragraph.

(1) Boiling-point range: 175 deg. F-300 deg. F.

(2) Nonvolatile residue: 0.002 gram per 100 milliliters maximum.

(3) Ultraviolet absorbance limits, as follows:

Wavelength (milli-microns) Maximum absorbance per centimeter optical pathlength
280-2890.15
290-299.13
300-359.08
360-400.02

Analytical Specification for Petroleum Naphtha

general instructions

All glassware should be scrupulously cleaned to remove all organic matter such as oil, grease, detergent residues, etc. Examine all glassware, including stoppers and stopcocks, under ultraviolet light to detect any residual fluorescent contamination. As a precautionary measure, it is recommended practice to rinse all glassware with purified isooctane immediately before use. No grease is to be used on stopcocks or joints. Great care to avoid contamination of petroleum naphtha samples in handling and to assure absence of any extraneous material arising from inadequate packaging is essential. Because some of the polynuclear hydrocarbons sought in this test are very susceptible to photo-oxidation, the entire procedure is to be carried out under subdued light.

apparatus

Separatory funnels. 250-milliliter, and 2,000-milliliter capacity, equipped with tetrafluoroethylene polymer stopcocks.

Erlenmeyer flask. 125-milliliter with 24/40 standard taper neck.

Evaporation flask. 250-milliliter capacity all-glass flask equipped with 24/40 standard taper stopper having inlet and outlet tubes to permit passage of nitrogen across the surface of the container liquid to be evaporated.

Condenser. 24/40 joints, fitted with drying tube, length optional.

Spectrophotometric cells. Fused quartz cells, optical path length in the range of 5,000 centimeters +/-0.005 centimeter; also for checking spectrophotometer performance only, optical path length in the range 1,000 centimeter +/-0.005 centimeter. With distilled water in the cells, determine any absorbance difference.

Spectrophotometer. Spectral range 250-400 m[micro] with spectral slit width of 2 m[micro] or less; under instrument operating conditions for these absorbance measurements, the spectrophotometer shall also meet the following performance requirements:

Absorbance repeatability, +/-0.01 at 0.4 absorbance.

Absorbance accuracy, 1 +/-0.05 at 0.4 absorbance.

Wavelength repeatability, +/-0.2 millimicron.

Wavelength accuracy, +/-1.0 millimicron.

Ultraviolet lamp. Long wavelength (3400-3800Adeg. ).

reagents

Isooctane (2,2,4-trimethylpentane ). Use 180 milliliters in a 250-milliliter Erlenmeyer flask, add 1 milliliter of purified n -hexadecane, insert the head assembly, allow nitrogen gas to flow into the inlet tube and connect the outlet tube to a solvent trap and vacuum line in such a way as to prevent any back flow of condensate into the flask. The contents of the flask are evaporated on a steam bath until 1 milliliter of residue remains. Dissolve the 1 milliliter of hexadecane residue in isooctane and make up to 25 milliliters. Determine the absorbance in a 5-centimeter path length cell compared to isooctane as reference. The absorbance should not exceed 0.01 per centimeter path length between 280-400 m[micro]. If necessary, isooctane may be purified by passage through a column of activated silica gel (Grade 12, Davidson Chemical Co., Baltimore, Md., or equivalent) or by distillation.

Methyl alcohol, A.C.S. reagent grade. Use 10 milliliters and proceed as with isooctane. The absorbance per centimeter of path length should be 0.00 between 280-400 m[micro]. Methyl alcohol may be purified by simple distillation or by refluxing in the presence of potassium hydroxide (10 grams/2 liters) and zinc dust (25 grams/2 liters) for 3 hours followed by distillation.

n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n- hexadecane to 25 milliliters with isooctane and determine the absorbance in a 5-centimeter cell compared to isooctane as reference between 280-400 m[micro]. The absorbance per centimeter path length shall not exceed 0.00 in this range. Purify, if necessary, by percolation through activated silica gel or by distillation.

Sodium borohydride. 98 percent.

Water. All distilled water must be extracted with isooctane before use. A series of three successive extracts of 1.5 liters of distilled water with 100-milliliter portions of isooctane is satisfactory.

procedure

Determination of ultraviolet absorbance. Add a 25-milliliter aliquot of the hydrocarbon solvent together with 1 milliliter of hexadecane to the 125-milliliter Erlenmeyer flask. While flushing with nitrogen, evaporate to 1 milliliter on a steam bath. Nitrogen is admitted through a 8+/-1-milliliter outer-diameter tube, drawn out into a 2+/-1-centimeter long and 1+/-0.5-millimeter inner-diameter capillary tip. This is positioned so that the capillary tip extends 4 centimeters into the flask. The nitrogen flow rate is such that the surface of the liquid is barely disturbed. After the volume is reduced to that of the 1 milliliter of hexadecane, the flask is left on the steam bath for 10 more minutes before removing. Add 10 milliliters of purified isooctane to the flask and reevaporate the solution to a 1-milliliter volume in the same manner as described above, except do not heat for an added 10 minutes. Repeat this operation twice more. Let the flask cool.

Add 10 milliliters of methyl alcohol and about 0.3 gram of sodium borohydride. (Minimize exposure of the borohydride to the atmosphere; a measuring dipper may be used.) Immediately fit a water-cooled condenser equipped with a 24/40 joint and with a drying tube into the flask, mix until the sodium borohydride is dissolved, and allow to stand for 30 minutes at room temperature, with intermittent swirling. At the end of this time, disconnect the flask and evaporate the methyl alcohol on the steam bath under nitrogen until sodium borohydride begins to drop out of solution. Remove the flask and let it cool.

Add 6 milliliters of isooctane to the flask and swirl to wash the crystalline slurry. Carefully transfer the isooctane extract to a 250-milliliter separatory funnel. Dissolve the crystals in the flask with about 25 milliliters of distilled water and pour this also into the separatory funnel. Adjust the water volume in the separatory funnel to about 100 milliliters and shake for 1 minute. After separation of the layers, draw off the aqueous layer into a second 250-milliliter separatory funnel. Transfer the hydrocarbon layer in the first funnel to a 25-milliliter volumetric flask.

Carefully wash the Erlenmeyer flask with an additional 6 milliliters of isooctane, swirl, and transfer to the second separatory funnel. Shake the funnel for 1 minute. After separation of the layers, draw off the aqueous layer into the first separatory funnel. Transfer the isooctane in the second funnel to the volumetric flask. Again wash the Erlenmeyer flask with an additional 6 milliliters of isooctane, swirl, and transfer to the first separatory funnel. Shake the funnel for 1 minute. After separation of the layers, draw off the aqueous layer and discard. Transfer the isooctane layer to the volumetric flask and adjust the volume to 25 milliliters of isooctane. Mix the contents well, then transfer to the first separatory funnel and wash twice with 50-milliliter portions of distilled water. Discard the aqueous layers after each wash.

Determine the ultraviolet absorbance of the isooctane extract in 5-centimeter path length cells compared to isooctane as reference between 280-400 m[micro]. Determine a reagent blank concurrently with the sample, using 25 milliliters of purified isooctane instead of a solvent sample and measuring the ultraviolet absorbance of the blank between 280-400m[micro].

The reagent blank absorbance should not exceed 0.04 per centimeter path length between 280-289 m[micro]; 0.020 between 290-359 m[micro]; and 0.010 between 360-400 m[micro].

Determination of boiling-point range. Use ASTM method D86-82, "Standard Method for Distillation of Petroleum Products," which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Determination of nonvolatile residue. For hydrocarbons boiling below 121 deg. C, determine the nonvolatile residue by ASTM method D1353-78, "Standard Test Method for Nonvolatile Matter in Volatile Solvents for Use in Paint, Varnish, Lacquer, and Related Products;" for those boiling above 121 deg. C, use ASTM method D381-80, "Standard Test Method for Existent Gum in Fuels by Jet Evaporation," which methods are incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) Petroleum naphtha containing antioxidants shall meet the specified ultraviolet absorbance limits after correction for any absorbance due to the antioxidants. Petroleum naphtha may contain antioxidants authorized for use in food in an amount not to exceed that reasonably required to accomplish the intended effect or to exceed any prescribed limitations.

(d) Petroleum naphtha is used or intended for use as a solvent in protective coatings on fresh citrus fruit in compliance with 172.210.

1As determined by procedure using potassium chromate for reference standard and described in National Bureau of Standards Circular 484, Spectrophotometry, U.S. Department of Commerce, (1949). The accuracy is to be determined by comparison with the standard values at 290, 345, and 400 millimicrons. The procedure is incorporated by reference. Copies of the material incorporated by reference are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11835, Mar. 19, 1982; 49 FR 10104, Mar. 19, 1984; 54 FR 24896, June 12, 1989]

Sec. 172.255 Polyacrylamide.

Polyacrylamide containing not more than 0.2 percent of acrylamide monomer may be safely used as a film former in the imprinting of soft-shell gelatin capsules when the amount used is not in excess of the minimum required to produce the intended effect.

Sec. 172.260 Oxidized polyethylene.

Oxidized polyethylene may be safely used as a component of food, subject to the following restrictions:

(a) Oxidized polyethylene is the basic resin produced by the mild air oxidation of polyethylene. The polyethylene used in the oxidation process conforms to the density, maximum n- hexane extractable fraction, and maximum xylene soluble fraction specifications prescribed in item 2.3 of the table in 177.1520(c) of this chapter. The oxidized polyethylene has a minimum number average molecular weight of 1,200, as determined by high temperature vapor pressure osmometry; contains a maximum of 5 percent by weight of total oxygen; and has an acid value of 9 to 19.

(b) The additive is used or intended for use as a protective coating or component of protective coatings for fresh avocados, bananas, beets, coconuts, eggplant, garlic, grapefruit, lemons, limes, mango, muskmelons, onions, oranges, papaya, peas (in pods), pineapple, plantain, pumpkin, rutabaga, squash (acorn), sweetpotatoes, tangerines, turnips, watermelon, Brazil nuts, chestnuts, filberts, hazelnuts, pecans, and walnuts (all nuts in shells).

(c) The additive is used in accordance with good manufacturing practice and in an amount not to exceed that required to produce the intended effect.

Sec. 172.270 Sulfated butyl oleate.

Sulfate butyl oleate may be safely used in food, subject to the following prescribed conditions:

(a) The additive is prepared by sulfation, using concentrated sulfuric acid, of a mixture of butyl esters produced by transesterification of an edible vegetable oil using 1-butanol. Following sulfation, the reaction mixture is washed with water and neutralized with aqueous sodium or potassium hydroxide. Prior to sulfation, the butyl oleate reaction mixture meets the following specifications:

(1) Not less than 90 percent butyl oleate.

(2) Not more than 1.5 percent unsaponifiable matter.

(b) The additive is used or intended for use at a level not to exceed 2 percent by weight in an aqueous emulsion in dehydrating grapes to produce raisins, whereby the residue of the additive on the raisins does not exceed 100 parts per million.

[57 FR 12711, Apr. 13, 1992]

Sec. 172.275 Synthetic paraffin and succinic derivatives.

Synthetic paraffin and succinic derivatives identified in this section may be safely used as a component of food, subject to the following restrictions:

(a) The additive is prepared with 50 percent Fischer-Tropsch process synthetic paraffin, meeting the definition and specifications of 172.615, and 50 percent of such synthetic paraffin to which is bonded succinic anhydride and succinic acid derivatives of isopropyl alcohol, polyethylene glycol, and polypropylene glycol. It consists of a mixture of the Fischer-Tropsch process paraffin (alkane), alkyl succinic anhydride, alkyl succinic anhydride isopropyl half ester, dialkyl succinic anhydride polyethylene glycol half ester, and dialkyl succinic anhydride polypropylene glycol half ester, where the alkane (alkyl) has a chain length of 30-70 carbon atoms and the polyethylene and polypropylene glycols have molecular weights of 600 and 260, respectively.

(b) The additive meets the following specifications: Molecular weight, 880-930; melting point, 215deg. -217 deg. F; acid number, 43-47; and saponification number, 75-78.

(c) It is used or intended for use as a protective coating or component of protective coatings for fresh grapefruit, lemons, limes, muskmelons, oranges, sweetpotatoes, and tangerines.

(d) It is used in an amount not to exceed that required to produce the intended effect.

Sec. 172.280 Terpene resin.

The food additive terpene resin may be safely used in accordance with the following prescribed conditions:

(a) The food additive is the betapinene polymer obtained by polymerizing terpene hydrocarbons derived from wood. It has a softening point of 112 deg. C-118 deg. C, as determined by ASTM method E28-67 (Reapproved 1982), "Standard Test Method for Softening Point By Ring-and-Ball Apparatus," which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(b) It is used or intended for use as follows:

(1) As a moisture barrier on soft gelatin capsules in an amount not to exceed 0.07 percent of the weight of the capsule.

(2) As a moisture barrier on powders of ascorbic acid or its salts in an amount not to exceed 7 percent of the weight of the powder.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10104, Mar. 19, 1984]

Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.
Source: 42 FR 14491, Mar. 15, 1977, unless otherwise noted.

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