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178.3297 Colorants for polymers.

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[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: 21CFR178.3297]

[Page 402-406]
 
                        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.  178.3297  Colorants for polymers.

    The substances listed in paragraph (e) of this section may be safely 
used as colorants 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 and definitions set forth in this 
section:
    (a) The term colorant means a dye, pigment, or other substance that 
is used to impart color to or to alter the color of a food-contact 
material, but that does not migrate to food in amounts that will 
contribute to that food any color apparent to the naked eye. For the 
purpose of this section, the term ``colorant'' includes substances such 
as optical brighteners and fluorescent whiteners, which may not 
themselves be colored, but whose use is intended to affect the color of 
a food-contact material.
    (b) The colorant must be used in accordance with current good 
manufacturing practice, including use levels which are not in excess of 
those reasonably required to accomplish the intended coloring effect.
    (c) Colorants in this section must conform to the description and 
specifications indicated. If a polymer described in this section is 
itself the subject of a regulation promulgated under section 409 of the 
Federal Food, Drug, and Cosmetic Act, it shall also comply with any 
specifications and limitations prescribed by that regulation. Extraction 
testing guidelines to conduct studies for additional uses of colorants 
under this section are available from the Food and Drug Administration 
free of charge from the Center for Food Safety and Applied Nutrition, 
(HFS-200) Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740.

[[Page 403]]

    (d) Color additives and their lakes listed for direct use in foods, 
under the provisions of the color additive regulations in parts 73, 74, 
81, and 82 of this chapter, may also be used as colorants for food-
contact polymers.
    (e) List of substances:

------------------------------------------------------------------------
               Substances                          Limitations
------------------------------------------------------------------------
Aluminum...............................
Aluminum hydrate.......................
Aluminum and potassium silicate (mica).
Aluminum mono-, di-, and tristearate...
Aluminum silicate (China clay).........
4-[[5-[[[4-(Aminocarbonyl) phenyl]       For use at levels not to exceed
 amino]carbonyl]- 2-methoxyphenyl]azo]-   1 percent by weight of
 N-(5-chloro-2,4-dimethoxyphenyl)-3-      polymers. The finished
 hydroxy-2-naphthalene-carboxamide        articles are to contact foods
 (C.I. Pigment Red 187, CAS Reg. No.      only under conditions of use B
 59487-23-9).                             through H described in table 2
                                          of Sec.   176.170(c) of this
                                          chapter.
N-[4-(Aminocarbonyl)phenyl]-4-[[1-       For use at levels not to exceed
 [[(2,3-dihydro-2-oxo-1H-benzimidazol-5-  1 percent by weight of
 yl)amino]carbonyl]-2-                    polymers. The finished
 oxopropyl]azo]benzamide (C. I. Pigment   articles are to contact food
 Yellow 181, CAS Reg. No. 74441-05-7).    only under conditions of use B
                                          through H described in table 2
                                          of Sec.   176.170(c) of this
                                          chapter.
Anthra(2,1,9-def:(6,5,10-                For use at levels not to exceed
 d'e'f)diisoquinoline-1,3,8,10(2H,9H)-    1% by weight of polymers. The
 tetrone (C.I. Pigment Violet 29; CAS     finished articles are to
 Reg. No. 81-33-4).                       contact food only under
                                          conditions of use B through H
                                          as described in Table 2 of
                                          Sec.   176.170(c) of this
                                          chapter.
Barium sulfate.........................
Bentonite..............................
Bentonite, modified with 3-
 dimethyldioctadecylammonium ion.
1,4-Bis[(2,4,6-trimethylphenyl)amino]-   For use at levels not to exceed
 9,10-anthracenedione (CAS Reg. No. 116-  0.0004 percent by weight of
 75-6).                                   polyethylene phthalate
                                          polymers complying with Sec.
                                          177.1630 of this chapter.
3,6-Bis(4-chlorophenyl)-2,5-dihydro-     For use only at levels not to
 pyrrolo[3,4-c]pyrrole-1,4-dione (C.I.    exceed 1 percent by weight of
 Pigment Red 254, CAS Reg. No. 84632-65-  polymers. The finished
 5).                                      articles are to contact food
                                          only under conditions of use B
                                          through H, described in table
                                          2 of Sec.   176.170(c) of this
                                          chapter.
4,4'-Bis(4-anilino-6-diethanolamine-     For use only in the textile
 [alpha]-triazin-2-ylamino)-2,2'-         fibers specified in Sec.
 stilbene disulfonic acid, disodium       177.2800 of this chapter.
 salt.
4,4'-Bis(4-anilino-6-methylethanolamine-  Do.
 [alpha]-triazin-2-ylamino)-2,2'-
 stilbene disulfonic acid, disodium
 salt.
Burnt umber............................
Calcium carbonate......................
Calcium silicate.......................
Calcium sulfate........................
Carbon black (channel process, prepared
 by the impingement process from
 stripped natural gas).
4-Chloro-2-[[5-hydroxy-3-methyl-1-(3-    For use at levels not to exceed
 sulfophenyl)-1H-pyrazol-4-yl]azo]-5-     1.0 percent by weight of the
 methylbenzenesulfonic acid, calcium      finished polymers. The
 salt (1:1); (C.I. Pigment Yellow 191,    finished articles are to
 CAS Reg. No. 129423-54-7).               contact food only under
                                          conditions of use B through H
                                          as described in table 2 of
                                          Sec.   176.170(c) of this
                                          chapter.
 4-Chloro-2-[[5-hydroxy-3-methyl-1-(3-   For use at levels not to exceed
 sulfophenyl)-1H-pyrazol-4-yl]azo]-5-     0.5 percent by weight of
 methylbenzenesulfonic acid, diammonium   polymers. The finished
 salt (1:2): (C.I. Pigment Yellow         articles are to contact food
 191:1, CAS Reg. No. 154946-66-4).        under conditions of use A
                                          through H described in Table 2
                                          of Sec.   176.170(c) of this
                                          chapter.
Chrome antimony titanium buff rutile     For use at levels not to exceed
 (C.I. Pigment Brown 24, CAS Reg. No.     1 percent by weight of
 68186-90-3).                             polymers. The finished
                                          articles are to contact food
                                          only under conditions of use B
                                          through H as described in
                                          Table 2 of Sec.   176.170(c)
                                          of this chapter.
Chromium oxide green, Cr2O3 (C.I.        For use only:
 Pigment Green 17, C.I. No. 77288).      1. In polymers used in contact
                                          with food at a level not to
                                          exceed 5 percent by weight of
                                          the polymer, except as
                                          specified below.
                                         2. In olefin polymers complying
                                          with Sec.   177.1520 of this
                                          chapter.
                                         3. In repeat-use rubber
                                          articles complying with Sec.
                                          177.2600 of this chapter;
                                          total use is not to exceed 10
                                          percent by weight of rubber
                                          articles.

[[Page 404]]


Cobalt aluminate.......................  For use only:
                                         1. In resinous and polymeric
                                          coatings complying with Sec.
                                          175.300 of this chapter.
                                         2. Melamine-formaldehyde resins
                                          in molded articles complying
                                          with Sec.   177.1460 of this
                                          chapter.
                                         3. Xylene-formaldehyde resins
                                          condensed with 4-
                                          4'isopropylidenediphenol-
                                          epichlorohydrin epoxy resins
                                          complying with Sec.   175.380
                                          of this chapter.
                                         4. Ethylene-vinyl acetate
                                          copolymers complying with Sec.
                                            177.1350 of this chapter.
                                         5. Urea-formaldehyde resins in
                                          molded articles complying with
                                          Sec.   177.1900 of this
                                          chapter.
                                         6. At levels not to exceed 5
                                          percent by weight of all
                                          polymers except those listed
                                          under limitations 1 through 5
                                          of this item. The finished
                                          articles are to contact food
                                          under conditions of use A
                                          through H described in table 2
                                          of Sec.   176.170(c) of this
                                          chapter.
Copper chromite black spinel (C.I.       For use at levels not to exceed
 Pigment Black 28, CAS Reg. No. 68186-    5 percent by weight of
 91-4).                                   polymers. The finished
                                          articles are to contact food
                                          only under conditions of use A
                                          through H as described in
                                          table 2 of Sec.   176.170(c)
                                          of this chapter.
D&C Red No. 7 and its lakes............
Diatomaceous earth.....................
4,4'-Diamino-[1,1'-bianthracene]-        For use at levels not to exceed
 9,9',10,10'-tetrone (CAS Reg. No. 4051-  1 percent by weight of
 63-2).                                   polymers. The finished
                                          articles are to contact food
                                          only under conditions of use B
                                          through H described in table 2
                                          of Sec.   176.170(c) of this
                                          chapter.
2,9-Dichloro-5,12-dihydroquinone[2,3-    For use at levels not to exceed
 b]acridine-7,14-dione (C.I. Pigment      1.0 percent by weight of
 Red 202, CAS Reg. No. 3089-17-6).        polymers.
4,5-Dichloro-2-((5-hydroxy-3-methyl-1-   For use only:
 (3-sulfophenyl)-1H-pyrazol-4-           1. At levels not to exceed 1
 yl)azo)benzenesulfonic acid, calcium     percent by weight of
 salt(1:1), (C.I. Pigment Yellow 183,     polypropylene polymers and
 CAS Reg. No. 65212-77-3).                copolymers complying with Sec.
                                            177.1520(c) of this chapter,
                                          items 1.1a, 1.1b, 1.2, 1.3,
                                          3.1a, 3.1b, 3.1c, 3.2a, 3.2b,
                                          3.4, or 3.5. The finished
                                          articles are to contact food
                                          only under conditions of use E
                                          through G, as described in
                                          Table 2 of Sec.   176.170(c)
                                          of this chapter.
                                         2. At levels not to exceed 1
                                          percent by weight of high
                                          density polyethylene polymers
                                          and copolymers complying with
                                          Sec.   177.1520(c) of this
                                          chapter, items 2.1, 2.2, 2.3,
                                          3.1a, 3.1b, 3.1c, 3.2a, 3.2b,
                                          3.6 (density not less than
                                          0.94 grams per cubic
                                          centimeter), or 5. The
                                          finished articles are to
                                          contact food only under
                                          conditions of use E through G,
                                          as described in Table 2 of
                                          Sec.   176.170(c) of this
                                          chapter.
5-[(2,3-Dihydro-6-methyl-2-oxo-1H-       For use at levels not to exceed
 benzimidazol-5-yl)azo]-2,4,6(1H, 3H,     1 percent by weight of
 5H)-pyrimidinetrione (CAS Reg. No.       polymers. The finished
 72102-84-2).                             articles are to contact food
                                          only under conditions of use B
                                          through H described in table 2
                                          of Sec.   176.170(c) of this
                                          chapter.
2,9-Dimethylanthra(2,1,9-def:6,5,10-     For use at levels not to exceed
 d'e'f')diisoquinoline-1,3,8,10(2H,9H)-   1 percent by weight of
 tetrone (C.I. Pigment Red 179, CAS       polymers. The finished
 Reg. No. 5521-31-3).                     articles are to contact food
                                          only under conditions of use B
                                          through H as described in
                                          Table 2 of Sec.   176.170(c)
                                          of this chapter.
3,3'-[(2,5-Dimethyl-1,4-                 For use at levels not to exceed
 phenylene)bis[imino(1-acetyl-2-oxo-2,1-  1 percent by weight of
 ethanediyl)azo]]bis[4-chloro-N-(5-       polymers. The finished
 chloro-2-methylphenyl)-benzamide] (CAS   articles are to contact food
 Reg. No. 5280-80-8).                     only under conditions of use B
                                          through H described in table 2
                                          of Sec.   176.170(c) of this
                                          chapter.
3,3'-[(2,5-Dimethyl-1,4-                 For use at levels not to exceed
 phenylene)bis[imino-carbonyl(2-hydroxy-  1 percent by weight of
 3,1-naphthalenediyl) azo]] bis(4-        polymers. The finished
 methylbenzoic acid), bis(2-              articles are to contact food
 chloroethyl) ester (CAS Reg. No. 68259-  only under conditions of use B
 05-2).                                   through H described in table 2
                                          of Sec.   176.170(c) of this
                                          chapter.
2,2'-[1,2-Ethanediylbis(oxy-2,1-         For use at levels not to exceed
 phenyleneazo)]bis[N-(2,3-dihydro-2-oxo-  1.0 percent by weight of
 1H-benzimidazol-5-yl)]-3-oxo-            polymers. The finished
 butanamide (C.I. Pigment Yellow 180,     articles are to contact food
 CAS Reg. No. 77804-81-0).                only under conditions of use B
                                          through G described in table 2
                                          of Sec.   176.170(c) of this
                                          chapter.
2,2'-(1,2-Ethenediyldi-4,1-phenylene)    For use as an optical
 bis(benzoxazole) (CAS Reg. No. 1533-45-  brightener for all polymers at
 5).                                      a level not to exceed 0.025
                                          percent by weight of polymer.
                                          The finished polymer shall
                                          contact foods only of the
                                          types identified in table 1 of
                                          Sec.   176.170(c) of this
                                          chapter, under categories I,
                                          II, IV-B, VI-A, VI-B, VII-B,
                                          and VIII at temperatures not
                                          to exceed 275 [deg]F.

[[Page 405]]


High-purity furnace black (CAS Reg. No.  For use at levels not to exceed
 1333-86-4) containing total              2.5 percent by weight of the
 polynuclear aromatic hydrocarbons not    polymer.
 to exceed 0.5 parts per million, and
 benzo[a]pyrene not to exceed 5.0 parts
 per billion, as determined by a method
 entitled ``Determination of PAH
 Content of Carbon Black,'' dated July
 8, 1994, as developed by the Cabot
 Corp., which is incorporated by
 reference in accordance with 5 U.S.C.
 552(a) and 1 CFR part 51. Copies may
 be obtained from the Office of
 Premarket Approval (HFS-200), Center
 for Food Safety and Applied Nutrition,
 Food and Drug Administration, 5100
 Paint Branch Pkwy., College Park, MD
 20740, or may be examined at the
 Center for Food Safety and Applied
 Nutrition's Library, 5100 Paint Branch
 Pkwy., College Park, MD 20740, 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..
Iron oxides............................
Kaolin-modified, produced by treating    For use only in olefin polymers
 kaolin with a reaction product of        complying with Sec.   177.1520
 isopropyl titanate and oleic acid in     of this chapter at levels not
 which 1 mole of isopropyl titanate is    to exceed 40 percent by weight
 reacted with 1 to 2 moles of oleic       of olefin polymer.
 acid. The reaction product will not
 exceed 8 percent of the modified
 kaolin. The oleic acid used shall meet
 the requirements specified in Sec.
 172.860 of this chapter.
Magnesium oxide........................
Magnesium silicate (talc)..............
Manganese Violet (manganese ammonium     For use at levels not to exceed
 pyrophosphate; CAS Reg. No. 10101-66-    2 percent by weight of
 3)..                                     polymers. The finished
                                          articles are to contact food
                                          only under conditions of use A
                                          through H as described in
                                          table 2 of Sec.   176.170(c)
                                          of this chapter.
Mixed methylated 4,4'-bis(2-             For use as an optical
 benzoxazolyl)stilbenes with the major    brightener only at levels not
 portion consisting of 4-(2-              to exceed 0.05 percent by
 benzoxazolyl)-4'-(5-methyl-2-            weight of rigid and semirigid
 benzoxazolyl)stilbene (CAS Registry      polyvinyl chloride and not to
 No. 5242-49-9) and lesser portions       exceed 0.03 percent by weight
 consisting of 4,4'-bis(5-methyl-2-       in all other polymers. The
 benzoxazolyl)stilbene (CAS Registry      finished food-contact articles
 No. 2397-00-4) and 4,4'-bis(2-           shall be used only under
 benzoxazolyl)stilbene (CAS Registry      conditions of use D, E, F, and
 No. 1533-45-5).                          G described in table 2 of Sec.
                                            176.170(c) of this chapter.
7-(2H-Naphtho[1,2-d]triazol-2-yl)-3-     For use as an optical
 phenylcoumarin (CAS Reg. No. 3333-62-    brightener only in:
 8) having a melting point of 250        1. Olefin polymers complying
 [deg]C to 251 [deg]C and a nitrogen      with Sec.   177.1520 of this
 content of 10.7 to 11.2 percent.         chapter only at levels such
                                          that the product of
                                          concentration of the optical
                                          brightener (expressed in parts
                                          per million by weight of the
                                          olefin polymer) multiplied by
                                          the thickness of the olefin
                                          polymer (expressed in
                                          thousandths of an inch and
                                          limited to no more than 0.400
                                          inch) shall not exceed 500;
                                          provided that the level of the
                                          brightener shall not exceed 20
                                          parts per million by weight of
                                          the olefin polymer, and
                                          further that the olefin
                                          polymers shall comply with
                                          specifications for items 1.1,
                                          2.1, 3.1, 3.3, and 4 of Sec.
                                          177.1520(c) of this chapter.
                                          The polymer may be used under
                                          the conditions described in
                                          Sec.   176.170(c) of this
                                          chapter, table 2, under
                                          conditions of use E, F, and G.
                                         2. Polyethylene terephthalate
                                          specified in Sec.
                                          177.2800(d)(5)(i) of this
                                          chapter at a level not to
                                          exceed 0.035 percent by weight
                                          of the finished fibers.
Nickel antimony titanium yellow rutile   For use at levels not to exceed
 (C.I. Pigment Yellow 53, CAS Reg. No.    1 percent by weight of
 8007-18-9).                              polymers. The finished
                                          articles are to contact food
                                          only under conditions of use B
                                          through H as described in
                                          Table 2 of Sec.   176.170(c)
                                          of this chapter.
1,1'-[(6-Phenyl-1,3,5-triazine-2,4-      For use at levels not to exceed
 diyl)diimino]bis-9,10-anthracenedione    0.25 percent by weight of
 (CAS Reg. No. 4118-16-5).                polyethylene phthalate
                                          polymers that comply with Sec.
                                            177.1630 of this chapter.
                                          The finished articles are to
                                          contact food only under
                                          conditions of use E, F, and G
                                          described in table 2, Sec.
                                          176.170(c) of this chapter,
                                          except, when such articles are
                                          used with food types III, IV-
                                          A, and V, described in table
                                          1, Sec.   176.170(c) of this
                                          chapter, the finished articles
                                          are to contact food only under
                                          conditions of use D, E, F, and
                                          G.
Phthalocyanine blue (C.I. pigment blue
 15, 15:1, 15:2, 15:3, and 15:4; C.I.
 No. 74160; CAS Reg. No. 147-14-8).
Phthalocyanine green (C.I. pigment
 green 7, C.I. No. 74260).
C.I. Pigment red 38 (C.I. No. 21120)...  For use only in rubber articles
                                          for repeated use complying
                                          with Sec.   177.2600 of this
                                          chapter; total use is not to
                                          exceed 10 percent by weight of
                                          rubber article.

[[Page 406]]


Quinacridone red (C.I. Pigment violet
 19, C.I. No. 73900).
Sienna (raw and burnt).................
Silica.................................
2,3,4,5-Tetrachloro-6-cyanobenzoic       For use only at levels not to
 acid, methyl ester reaction products     exceed 1 percent by weight of
 with p-phenyllenediamine and sodium      polymers. The finished
 methoxide (CAS reg. No. 106276-80-6).    articles are to contact food
                                          only under conditins of use B
                                          through H, described in table
                                          2, of Sec.   176.170(c) of
                                          this chapter.
4,5,6,7-Tetrachloro-2-[2-(4,5,6,7-       For use only at levels not to
 tetrachloro-2,3-dihydro-1,3-dioxo-1H-    exceed 1 percent by weight of
 inden-2-yl)-8-quinolinyl]-1H-isoindole-  polymers. The finished
 1,3(2H)-dione (C. I. Pigment Yellow      articles are to contact food
 138, CAS Reg. No.30125-47-4).            only under conditions of use C
                                          through H, as described in
                                          table 2 of Sec.   176.170(c)
                                          of this chapter; provided
                                          further that the finished
                                          articles shall not be filled
                                          at temperatures exceeding 158
                                          [deg]F (70 [deg]C).
2,2'-(2,5-Thiophenediyl)-bis(5-tert-     For use as an optical
 butylbenzoxazole) (CAS Reg. No. 7128-    brightener:
 64-5).                                  1. In all polymers at levels
                                          not to exceed 0.015 percent by
                                          weight of the polymer. The
                                          finished articles are to
                                          contact food only under
                                          conditions of use A through H
                                          described in table 2 of Sec.
                                          176.170(c) of this chapter.
                                         2. In all polymers at levels
                                          not to exceed 0.05 percent by
                                          weight of the polymer. The
                                          finished articles shall
                                          contact foods only of the
                                          types identified in table 1 of
                                          Sec.   176.170(c) of this
                                          chapter, under Categories I,
                                          II, IV-B, VI-A, VI-B, VI-C,
                                          VII-B, and VIII under
                                          conditions of use A through H
                                          described in table 2 of Sec.
                                          176.170(c) of this chapter.
                                         3. In adhesives complying with
                                          Sec.   175.105 of this chapter
                                          and in pressure-sensitive
                                          adhesives complying with Sec.
                                           175.125 of this chapter.
Titanium dioxide.......................
Titanium dioxide-barium sulfate........
Titanium dioxide-magnesium silicate....
Ultramarines...........................  As identified in Sec.   73.2725
                                          of this chapter.
Zinc carbonate.........................  For use only:
                                         1. In resinous and polymeric
                                          coatings complying with Sec.
                                          175.300 of this chapter.
                                         2. Melamineformaldehyde resins
                                          in molded articles complying
                                          with Sec.   177.1460 of this
                                          chapter.
                                         3. Xylene-formaldehyde resins
                                          condensed with 4-4'-
                                          isopropylidene diphenol-
                                          epichlorohydrin epoxy resins
                                          complying with Sec.   175.380
                                          of this chapter.
                                         4. Ethylene-vinyl acetate
                                          copolymers complying with Sec.
                                            177.1350 of this chapter.
                                         5. Urea-formaldehyde resins in
                                          molded articles complying with
                                          Sec.   177.1900 of this
                                          chapter.
Zinc chromate..........................  For use only in rubber articles
                                          for repeated use complying
                                          with Sec.   177.2600 of this
                                          chapter; total use is not to
                                          exceed 10 percent by weight of
                                          rubber article.
Zinc oxide.............................  For use only:
                                         1. In resinous and polymeric
                                          coatings complying with Sec.
                                          175.300 of this chapter.
                                         2. Melamine-formaldehyde resins
                                          in molded articles complying
                                          with Sec.   177.1460 of this
                                          chapter.
                                         3. Xylene-formaldehyde resins
                                          condensed with 4-4'-
                                          isopropylidene-diphenol-
                                          epichlorohydrin epoxy resins
                                          complying with Sec.   175.380
                                          of this chapter.
                                         4. Ethylene-vinyl acetate
                                          copolymers complying with Sec.
                                            177.1350 of this chapter.
                                         5. Urea-formaldehyde resins in
                                          molded articles complying with
                                          Sec.   177.1900 of this
                                          chapter.
Zinc sulfide...........................  For use at levels not to exceed
                                          10 percent by weight.
------------------------------------------------------------------------


[48 FR 46775, Oct. 14, 1983]

    Editorial Note: For Federal Register citations affecting Sec.  
178.3297, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.

[[Page 407]]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 178, Section 3297


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