178.3870 Rosins and rosin derivatives.

Home > Regulations > Indirect food additives: Adjuvants, production aids, and sanitizers > 178.3870 Rosins and rosin derivatives.


[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: 21CFR178.3870]

[Page 441-444]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 178_INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND 
SANITIZERS--Table of Contents
 
             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 95[deg]-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 88[deg]-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 79[deg]-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 109[deg]-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 165[deg]-175 [deg]C, and a color 
of H or paler.

[[Page 442]]

    (v) Glycerol ester of maleic anhydride-modified wood rosin, having 
an acid number of 30 to 40, a drop-softening point of 138[deg]-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 109[deg]-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 102[deg]-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 154[deg]-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 130[deg]-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 127[deg]-
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 131[deg]-
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 162[deg]-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 113[deg]-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 136[deg]-140 
[deg]C, a color of M or paler, and a saponification number less than 
280. For use only in cellophane complying with Sec.  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 105[deg]-115 [deg]C, and 
a color of K or paler. For use only as a blending agent in coatings for 
cellophane complying with Sec.  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 80[deg]-
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 141[deg]-
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 84[deg]-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.

[[Page 443]]

    (c) The use in any substance or article that is the subject of a 
regulation in parts 174, 175, 176, 177, 178 and Sec.  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 Sec.  175.300(b)(3)(v) of this chapter 
and used in resinous and polymeric coatings complying with Sec.  175.300 
of this chapter.
    (e) The provisions of this section are not applicable to rosins and 
rosin derivatives identified in Sec.  175.105(c)(5) of this chapter and 
used in defoaming agents complying with Sec.  176.210 of this chapter, 
food-packaging adhesives complying with Sec.  175.105 of this chapter, 
and rubber articles complying with Sec.  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, 5100 Paint Branch Pkwy., 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/

[[Page 444]]

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]
Additives that reference this regulation:
Source: U.S. Code of Federal Regulations - CFR Title 21, Part 178, Section 3870
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