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 Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1200
(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.
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 F.
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 Food
Additive Safety (HFS-200), Center for
Food Safety and Applied Nutrition,
Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD
20740, 240-402-1200, 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 C to 1. Olefin polymers complying
251 C and a nitrogen content of 10.7 with Sec. 177.1520 of this
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.
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 F
(70 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 at www.fdsys.gov.