[Title 21 CFR 178.3297]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)]
[Subchapter B - FOOD FOR HUMAN CONSUMPTION]
[Part 178 - INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS]
[Subpart D - Certain Adjuvants and Production Aids]
[Sec. 178.3297 - Colorants for polymers.]
[From the U.S. Government Publishing Office]
21
FOOD AND DRUGS
3
1996-04-01
1996-04-01
false
Colorants for polymers.
178.3297
Sec. 178.3297
FOOD AND DRUGS
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
FOOD FOR HUMAN CONSUMPTION
INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
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, 200 C St. SW., Washington, DC
20204.
(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
amino]carbonyl]- 2-methoxyphenyl]azo]-N- exceed 1 percent by weight
(5-chloro-2,4-dimethoxyphenyl)-3-hydroxy- of polymers. The finished
2-naphthalene-carboxamide (C.I. Pigment articles are to contact
Red 187, CAS Reg. No. 59487-23-9). foods only under conditions
of use B through H
described in Table 2 of
Sec. 176.170(c) of this
chapter.
[[Page 359]]
N-[4-(Aminocarbonyl)phenyl]-4-[[1-[[(2,3- For use at levels not to
dihydro-2-oxo-1H-benzimidazol-5- exceed 1 percent by weight
yl)amino]carbonyl]-2- of polymers. The finished
oxopropyl]azo]benzamide (C. I. Pigment articles are to contact
Yellow 181, CAS Reg. No. 74441-05-7). food only under conditions
of use B through H
described in Table 2 of
Sec. 176.170(c) of this
chapter.
Barium sulfate............................
Bentonite.................................
Bentonite, modified with 3-
dimethyldioctadecylammonium ion.
4,4'-Bis(4-anilino-6-diethanolamine--triazin-2-ylamino)-2,2'-stilbene fibers specified in Sec.
disulfonic acid, disodium salt. 177.2800 of this chapter.
4,4'-Bis(4-anilino-6-methylethanolamine- Do.
-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
sulfophenyl)-1H-pyrazol-4-yl]azo]-5- exceed 0.3 percent by
methylbenzenesulfonic acid,calcium salt weight of the finished
(1:1); (C. I. Pigment Yellow 191, CAS polymers. The finished
Reg. No. 129423-54-7).. 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, Cr2 O3 (C.I. For use only:
pigment green 17, C.I. No. 77288). 1. In olefin polymers
complying with Sec.
177.1520 of this chapter.
2. 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. Pigment For use at levels not to
Black 28, CAS Reg. No. 68186-91-4).. exceed 5 percent by weight
of 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
9,9',10,10'-tetrone (CAS Reg. No. 4051-63- exceed 1 percent by weight
2). of 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.
5-[(2,3-Dihydro-6-methyl-2-oxo-1H- For use at levels not to
benzimidazol-5-yl)azo]-2,4,6(1H, 3H, 5H)- exceed 1 percent by weight
pyrimidinetrione (CAS Reg. No. 72102-84- of polymers. The finished
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.
3,3'-[(2,5-Dimethyl-1,4- For use at levels not to
phenylene)bis[imino(1-acetyl-2-oxo-2,1- exceed 1 percent by weight
ethanediyl)azo]]bis[4-chloro-N-(5-chloro- of polymers. The finished
2-methylphenyl)-benzamide] (CAS Reg. No. articles are to contact
5280-80-8). food 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
phenylene)bis[imino-carbonyl(2-hydroxy- exceed 1 percent by weight
3,1-naphthalenediyl) azo]] bis(4- of polymers. The finished
methylbenzoic acid), bis(2-chloroethyl) articles are to contact
ester (CAS Reg. No. 68259-05-2).. food only under conditions
of use B through H
described in Table 2 of
Sec. 176.170(c) of this
chapter.
[[Page 360]]
2,2'-[1,2-Ethanediylbis(oxy-2,1- For use at levels not to
phenyleneazo)]bis[N-(2,3-dihydro-2-oxo-1H- exceed 1.0 percent by
benzimidazol-5-yl)]-3-oxo-butanamide weight of polymers. The
(C.I. Pigment Yellow 180, CAS Reg. No. finished articles are to
77804-81-0). contact food 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. 1533-45-5). brightener for all polymers
at 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.
Iron oxides...............................
Kaolin-modified, produced by treating For use only in olefin
kaolin with a reaction product of polymers complying with
isopropyl titanate and oleic acid in Sec. 177.1520 of this
which 1 mole of isopropyl titanate is chapter at levels not to
reacted with 1 to 2 moles of oleic acid. exceed 40 percent by weight
The reaction product will not exceed 8 of olefin polymer.
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).................
7-(2H-Naphtho[1,2-d]triazol-2-yl)-3- For use as an optical
phenylcoumarin (CAS Reg. No. 3333-62-8) brightener only in:
having a melting point of 250 deg.C to 1. Olefin polymers
251 deg.C and a nitrogen content of 10.7 complying with Sec.
to 11.2 percent. 177.1520 of this 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.
1,1-[(6-Phenyl-1,3,5-triazine-2,4- For use at levels not to
diyl)diimino]bis-9,10-anthracenedione exceed 0.25 percent by
(CAS Reg. No. 4118-16-5). weight of 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....................................
4,5,6,7-Tetrachloro-2-[2-(4,5,6,7- For use only at levels not
tetrachloro-2,3-dihydro-1,3-dioxo-1H- to exceed 1 percent by
inden-2-yl)-8-quinolinyl]-1H-isoindole- weight of polymers. The
1,3(2H)-dione (C. I. Pigment Yellow 138, finished articles are to
CAS Reg. No.30125-47-4).. contact food 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. 7128-64- brightener only:
5). 1. At levels not to exceed
0.05 percent by weight of
the following polymers:
olefin polymers complying
with Sec. 177.1520(c) of
this chapter, item 2.1,
2.3, 3.1, 3.3, or 4;
polystyrene and
rubbermodified polystyrene
complying with Sec.
177.1640 of this chapter;
and polyvinyl chloride. The
finished polymers shall
contact foods only of the
types identified in Table
1, Sec. 176.170(c) of this
chapter, under Categories
I, II, IV-B, VI-A, VI-B,
and VIII under conditions
of use E, F, and G
described in Table 2 of
Sec. 176.170(c) of this
chapter.
2. At levels not to exceed
0.05 percent by weight of
polypropylene complying
with Sec. 177.1520(c) of
this chapter, item 1.1,
1.2, or 1.3. The finished
polymer shall contact foods
only of the types
identified in Table 1, Sec.
176.170(c) of this
chapter, under Categories
I, II, IV-B, VI, VII-B, and
VIII under conditions of
use A through H described
in Table 2 of Sec.
176.170(c) of this chapter.
[[Page 361]]
3. At levels not to exceed
0.01 percent by weight of
polypropylene complying
with Sec. 177.1520(c) of
this chapter, item 1.1,
1.2, or 1.3. The finished
polymer shall contact foods
only of the types
identified in Table 1, Sec.
176.170(c) of this
chapter, under Categories
III, IV-A, V, VII-A, and IX
under conditions of use A
through H described in
Table 2 of Sec. 176.170(c)
of this chapter.
4 At levels not to exceed
0.01 percent by weight of
polyoxymethylene complying
with Sec. 177.2480 of this
chapter.
5. At levels not to exceed
0.015 percent by weight of
polycarbonate resins
complying with Sec.
177.1580 of this chapter.
The finished polymer shall
contact foods of the types
identified in Table 1 of
Sec. 176.170(c) of this
chapter, under categories,
I, II, IV-B, VI-B, and VIII
under conditions of use B
through H described in
Table 2 of Sec. 176.170(c)
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 46774, 46775, Oct. 14, 1983, as amended at 51 FR 7551, Mar.
5, 1986; 51 FR 19168, May 28, 1986; 51 FR 23535, June 30, 1986; 53 FR
52132, Dec. 27, 1988; 54 FR 21053, May 16, 1989; 54 FR 24898, June 12,
1989; 54 FR 35875, Aug. 30, 1989; 55 FR 3585, Feb. 2, 1990; 55 FR 12344,
Apr. 3, 1990; 55 FR 18721, May 4, 1990; 55 FR 31827, Aug. 6, 1990; 56 FR
42933, Aug. 30, 1991; 56 FR 65782, Dec. 18, 1991; 58 FR 17514, Apr. 5,
1993; 58 FR 67323, Dec. 21, 1993; 59 FR 3654, Jan. 26, 1994; 59 FR 5705,
Feb. 8, 1994; 59 FR 10065, 10066, Mar. 3, 1994; 60 FR 31244, June 14,
1995; 60 FR 39648, Aug. 3, 1995; 61 FR 2116, Jan. 25, 1996; 61 FR 14246,
Apr. 1, 1996; 61 FR 14481, Apr. 2, 1996]