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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.

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

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2017]
[CITE: 21CFR172.210]



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 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]

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