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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 2018.

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, 2018]
[CITE: 21CFR178.3870]



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 178 -- INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS

Subpart D--Certain Adjuvants and Production Aids

Sec. 178.3870 Rosins and rosin derivatives.

The rosins and rosin derivatives identified in paragraph (a) of this section may safely be used in the manufacture of articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section.

(a) The rosins and rosin derivatives are identified as follows:

(1) Rosins:

(i) Gum rosin, refined to color grade of K or paler.

(ii) Wood rosin, refined to color grade of K or paler.

(iii) Tall oil rosin, refined to color grade of K or paler.

(iv) Dark tall oil rosin, a fraction resulting from the refining of tall oil rosin produced by multicolumnar distillation of crude tall oil to effect removal of fatty acids and pitch components and having a saponification number of from 110-135 and 32 percent-44 percent rosin acids.

(v) Dark wood rosin, all or part of the residue after the volatile terpene oils are distilled from the oleoresin extracted from pine wood.

(2) Modified rosins manufactured from rosins identified in paragraph (a)(1) of this section:

(i) Partially hydrogenated rosin, catalytically hydrogenated to a maximum refractive index of 1.5012 at 100 deg. C, and a color of WG or paler.

(ii) Fully hydrogenated rosin, catalytically hydrogenated to a maximum dehydroabietic acid content of 2 percent, a minimum drop-softening point of 79 deg. C, and a color of X or paler.

(iii) Partially dimerized rosin, dimerized by sulfuric acid catalyst to a drop-softening point of 95deg. -105 deg. C and a color of WG or paler.

(iv) Fully dimerized rosin, dimerized by sulfuric acid catalyst, and from which sufficient nondimerized rosin has been removed by distillation to achieve a minimum drop-softening point of 143 deg. C, and a color of H or paler.

(v) Disproportionated rosin, catalytically disproportionated to a minimum dehydroabietic acid content of 35 percent, a maximum abietic acid content of 1 percent, a maximum content of substituted phenanthrenes (as retene) of 0.25 percent, and a color of WG or paler.

(3) Rosin esters manufactured from rosins and modified rosins identified in paragraphs (a)(1) and (2) of this section:

(i) Glycerol ester of wood rosin purified by steam stripping to have an acid number of 3 to 9, a drop-softening point of 88deg. -96 deg. C, and a color of N or paler.

(ii) Glycerol ester of partially hydrogenated wood rosin, having an acid number of 3 to 10, a drop-softening point of 79deg. -88 deg. C, and a color of N or paler.

(iii) Glycerol ester of partially dimerized rosin, having an acid number of 3 to 8, a drop-softening point of 109deg. -119 deg. C, and a color of M or paler.

(iv) Glycerol ester of fully dimerized rosin, having an acid number of 5 to 16, a drop-softening point of 165deg. -175 deg. C, and a color of H or paler.

(v) Glycerol ester of maleic anhydride-modified wood rosin, having an acid number of 30 to 40, a drop-softening point of 138deg. -146 deg. C, a color of M or paler, and a saponification number less than 280.

(vi) Methyl ester of rosin, partially hydrogenated, purified by steam stripping to have an acid number of 4 to 8, a refractive index of 1.5170 to 1.5205 at 20 deg. C, and a viscosity of 23 to 66 poises at 25 deg. C.

(vii) Pentaerythritol ester of wood rosin, having an acid number of 6 to 16, a drop-softening point of 109deg. -116 deg. C, and a color of M or paler.

(viii) Pentaerythritol ester of partially hydrogenated wood rosin, having an acid number of 7 to 18, a drop-softening point of 102deg. -110 deg. C, and a color of K or paler.

(ix) Pentaerythritol ester of maleic anhydride-modified wood rosin, having an acid number of 8 to 16, a drop-softening point of 154deg. -162 deg. C, a color of M or paler, and having a saponification number less than 280.

(x) Pentaerythritol ester of maleic anhydride-modified wood rosin, having an acid number of 9 to 16, a drop-softening point of 130deg. -140 deg. C, a color of N or paler, and having a saponification number less than 280.

(xi) Pentaerythritol ester of maleic anhydride-modified wood rosin, having an acid number of 134 to 145, a drop-softening point of 127deg. -137 deg. C, a color of M or paler, and having a saponification number less than 280.

(xii) Pentaerythritol ester of maleic anhydride-modified wood rosin, having an acid number of 30 to 40, a drop-softening point of 131deg. -137 deg. C, a color of N or paler, and having a saponification number less than 280.

(xiii) Pentaerythritol ester of maleic anhydride-modified wood rosin, further modified by reaction with 4,4'-isopropyl-idenediphenol-formaldehyde condensate, having an acid number of 10 to 22, a drop-softening point of 162deg. -172 deg. C, a color of K or paler, a saponification number less than 280, and a maximum ultraviolet absorbance of 0.14 at 296 m[micro] (using a 1-centimeter cell and 200 milligrams of the rosin ester per liter of solvent consisting of ethyl alcohol made alkaline by addition of 0.1 percent of potassium hydroxide).

(xiv) Mixed methyl and pentaerythritol ester of maleic anhydride-modified wood rosin, having an acid number of 73 to 83, a drop-softening point of 113deg. -123 deg. C, a color of M or paler, and a saponification number less than 280.

(xv) Triethylene glycol ester of partially hydrogenated wood rosin, having an acid number of 2 to 10, a color of K or paler, and a viscosity of 350 to 425 seconds Saybolt at 100 deg. C.

(xvi) Glycerol ester of maleic anhydride-modified wood rosin, having an acid number of 17 to 23, a drop-softening point of 136deg. -140 deg. C, a color of M or paler, and a saponification number less than 280. For use only in cellophane complying with 177.1200 of this chapter.

(xvii) Citric acid-modified glycerol ester of rosin, having an acid number less than 20, a drop-softening point of 105deg. -115 deg. C, and a color of K or paler. For use only as a blending agent in coatings for cellophane complying with 177.1200 of this chapter.

(xviii) Glycerol ester of tall oil rosin, purified by steam stripping to have an acid number of 5-12, a softening point of 80deg. -88 deg. C, and a color of N or paler.

(xix) Glycerol ester of maleic anhydride-modified tall oil rosin, having an acid number of 30 to 40, a drop-softening point of 141deg. -146 deg. C, a color of N or paler, and a saponification number less than 280.

(xx) Glycerol ester of disproportionated tall oil rosin, having an acid number of 5 to 10, a drop-softening point of 84deg. -93 deg. C, a color of WG or paler, and a saponification number less than 180.

(4) Rosin salts and sizes--Ammonium, calcium, potassium, sodium, or zinc salts of rosin manufactured by the partial or complete saponification of any one of the rosins or modified rosins identified in paragraph (a)(1) and (2) of this section, or blends thereof, and with or without modification by reaction with one or more of the following:

(i) Formaldehyde.

(ii) Fumaric acid.

(iii) Maleic anhydride.

(iv) Saligenin.

(b) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect.

(c) The use in any substance or article that is the subject of a regulation in parts 174, 175, 176, 177, 178 and 179.45 of this chapter shall conform with any specifications and limitations prescribed by such regulation for the finished form of the substance or article.

(d) The provisions of this section are not applicable to rosins and rosin derivatives identified in 175.300(b)(3)(v) of this chapter and used in resinous and polymeric coatings complying with 175.300 of this chapter.

(e) The provisions of this section are not applicable to rosins and rosin derivatives identified in 175.105(c)(5) of this chapter and used in defoaming agents complying with 176.210 of this chapter, food-packaging adhesives complying with 175.105 of this chapter, and rubber articles complying with 177.2600 of this chapter.

(f) The analytical methods for determining whether rosins and rosin derivatives conform to the specifications prescribed in paragraph (a) of this section are as follows:

(1) Color: Color shall be as determined by ASTM method D509-70 (Reapproved 1981), "Standard Methods of Sampling and Grading Rosin," 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: Refractive index shall be as determined by ASTM method D1747-62 (Reapproved 1978), "Standard Test Method for Refractive Index of Viscous Materials," which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (f)(1) of this section.

(3) Acid number: Acid number shall be as determined by ASTM method D465-82, "Standard Test Methods for Acid Number of Rosin," which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (f)(1) of this section.

(4) Viscosity: Viscosity in poises shall be as determined by ASTM method D1824-66 (Reapproved 1980), "Standard Test Method for Apparent Viscosity of Plastisols and Organosols at Low Shear Rates by Brookfield Viscometer," and in Saybolt seconds by ASTM method D88-81, "Standard Test Method for Saybolt Viscosity," which are incorporated by reference. The availability of this incorporation by reference is given in paragraph (f)(1) of this section.

(5) Softening point: Softening point shall be as determined by ASTM method E28-67, "Standard Test Method for Softening Point by Ring and Ball Apparatus" (Reapproved 1977), which is incorporated by reference. Copies are available from American Society for Testing and Materials (ASTM), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, 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.

(6) Analytical methods for determining drop-softening point, saponification number, and any other specifications not listed under paragraphs (f)(1) through (5) of this section, titled: (i) "Determination of Abeitic Acid and Dehydroabietic Acid in Rosins"; (ii) "Determination of Softening Point of Solid Resins"; (iii) "Determination of Saponification Number of Rosin Esters," and (iv) "Determination of Phenolic Modification of Rosin Derivatives," which are incorporated by reference. Copies 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 14609, Mar. 15, 1977, as amended at 47 FR 11849, Mar. 19, 1982; 49 FR 10113, Mar. 19, 1984; 54 FR 24899, June 12, 1989]

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