CFR 2011 Title21 Vol3 Part178 Subpartd

Food and Drug Administration, HHS § 178.
3120
552(a). The availability of this incorpo- List of substances Limitations

ration by reference is given in para- 1,1,2,2-Tetra- For use only as a blowing agent ad-
graph (b)(1)(ii) of this section. chloroethylene. juvant in polystyrene at a level not
(2) In lieu of the tests prescribed in to exceed 0.3 percent by weight of
finished foamed polystyrene in-
paragraph (b) (1) of this section, the tended for use in contact with food
finished plastics intended for contact only of the types identified in
with foods only of Types II, V, VI-A § 176.170(c) of this chapter, table
1, under Categories I, II, VI, and
(except malt beverages), and VI-C may VIII.
be end-tested with food-simulating sol- Toluene ...................... For use only as a blowing agent ad-
vents, under conditions of time and juvant in polystyrene at a level not
to exceed 0.35 percent by weight
temperature, as specified below, where- of finished foamed polystyrene.
by such tests shall yield the octyltin
residues cited in paragraph (b)(1) of
[47 FR 22090, May 21, 1982, as amended at 58
this section not in excess of 0.5 ppm: FR 64895, Dec. 10, 1993]
Tem-
perature § 178.3120 Animal glue.
Time
Food-simulating solvent (degrees
(hours) Fahr- Animal glue may be safely used as a
enheit) component of articles intended for use
Type II ......... Acetic acid, 3 pct ......... 48 135
in producing, manufacturing, packing,
Type V ......... Heptane ....................... 2 100 processing, preparing, treating, pack-
Type VI-A .... Ethyl alcohol, 8 pct ...... 24 120 aging, transporting, or holding food,
Type VI-C .... Ethyl alcohol, 50 per- 24 120 subject to the provisions of this sec-
cent. tion.
(a) Animal glue consists of the pro-
[42 FR 14609, Mar. 15, 1977, as amended at 47 teinaceous extractives obtained from
FR 11847, Mar. 19, 1982; 48 FR 7170, Feb. 18, hides, bones, and other collagen-rich
1983; 48 FR 42972, Sept. 21, 1983; 48 FR 51612, substances of animal origin (excluding
Nov. 10, 1983; 49 FR 8432, Mar. 7, 1984; 50 FR diseased or rotted animals), to which
62, Jan. 2, 1985; 50 FR 3510, Jan. 25, 1985; 50 FR may be added other optional adjuvant
37998, Sept. 19, 1985; 50 FR 47212, Nov. 15, 1985; substances required in its production
54 FR 24898, June 12, 1989] or added to impart desired properties.
(b) The quantity of any substance
Subpart D—Certain Adjuvants and employed in the production of animal
Production Aids glue does not exceed the amount rea-
sonably required to accomplish the in-
§ 178.3010 Adjuvant substances used in tended physical or technical effect nor
the manufacture of foamed plastics. any limitation further provided.
(c) Any substance employed in the
The following substances may be
production of animal glue and which is
safely used as adjuvants in the manu-
the subject of a regulation in parts 174,
facture of foamed plastics intended for
175, 176, 177, 178 and § 179.45 of this chap-
use in contact with food, subject to any ter conforms with any specification in
prescribed limitations: such regulation.
List of substances Limitations (d) Optional adjuvant substances em-
ployed in the production of animal glue
Azodicarbonamide ..... For use as a blowing agent in pol- include:
yethylene complying with item 2.1
in § 177.1520(c) of this chapter at
(1) Substances generally recognized
a level not to exceed 5 percent by as safe in food.
weight of finished foamed poly- (2) Substances subject to prior sanc-
ethylene. tion or approval for use in animal glue
1,1-Difluoroethane For use as a blowing agent in poly-
(CAS Reg. No. 75– styrene.
and used in accordance with such sanc-
37–6). tion or approval.
Isopentane ................. For use as a blowing agent in poly- (3) Substances identified in this para-
styrene. graph (d)(3) and subject to such limita-
n-Pentane .................. Do. tions as are provided:
wwoods2 on DSK1DXX6B1PROD with CFR
399
VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00409 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067
§ 178.3125 21 CFR Ch. I (4–1–11 Edition)
List of substances Limitations
Alum (double sulfate of aluminum and ammonium, potassium, or sodium).

4-Chloro-3-methylphenol(p-chlorome-tacresol) ............................................ For use as preservative only.
Chromium potassium sulfate (chrome alum) ............................................... For use only in glue used as a colloidal flocculant
added to the pulp suspension prior to the sheet-
forming operation in the manufacture of paper and
paper board.
3,5-Dimethyl-1,3,5,H-tetrahydrothiadia-zine-2-thione .................................. For use as preservative only.
Disodium cyanodithioimidocarbonate .......................................................... Do.
Defoaming agents ........................................................................................ As provided in § 176.210 of this chapter.
Ethanolamine.
Ethylenediamine.
Formaldehyde .............................................................................................. For use as a preservative only.
Potassium N-methyldithiocarbamate ........................................................... Do.
Potassium pentachlorophenate .................................................................... Do.
Rosins and rosin derivatives ........................................................................ As provided in § 178.3870.
Sodium chlorate.
Sodium dodecylbenzenesulfonate.
Sodium 2-mercaptobenzothiazole ................................................................ For use as preservative only.
Sodium pentachlorophenate ........................................................................ Do.
Sodium o-phenylphenate ............................................................................. Do.
Zinc dimethyldithiocarbamate ...................................................................... Do.
Zinc 2-mercaptobenzothiazole ..................................................................... Do.
(e) The conditions of use are as fol- food-contact materials subject to the
lows: provisions of this section:
(1) The use of animal glue in any sub-
Substances Limitations
stance or article that is the subject of
a regulation in this subpart conforms Zinc hydroxy For use only as a component of resinous
with any specifications or limitations phosphite and polymeric food-contact coatings in-
(CAS Reg. tended for repeated use in contact with
prescribed by such regulation for the No. 55799– dry foods.
finished form of the substance or arti- 16–1).
cle.
(2) It is used as an adhesive or compo- [50 FR 21835, May 29, 1985]
nent of an adhesive in accordance with
the provisions of § 175.105 of this chap- § 178.3130 Antistatic and/or anti-
ter. fogging agents in food-packaging
(3) It is used as a colloidal flocculant materials.
added to the pulp suspension prior to The substances listed in paragraph
the sheet-forming operation in the (b) of this section may be safely used as
manufacture of paper and paperboard. antistatic and/or antifogging agents in
(4) It is used as a protective colloid in food-packaging materials, subject to
resinous and polymeric emulsion coat- the provisions of this section:
ings. (a) The quantity used shall not ex-
ceed the amount reasonably required
§ 178.3125 Anticorrosive agents. to accomplish the intended technical
The substances listed in this section effect.
may be used as anticorrosive agents in (b) List of substances:
N-Acyl sarcosines where the acyl group is lauroyl, oleoyl, or For use only:
derived from the combined fatty acids of coconut oil. 1. As antistatic and/or antifogging agent at levels not to exceed
a total of 0.15 pct by weight of polyolefin film used for pack-
aging meat, fresh fruits, and fresh vegetables. The average
thickness of such polyolefin film shall not exceed 0.003 inch.
2. As antistatic and/or antifogging agent at levels not to exceed
a total of 0.15 pct by weight of ethylene-vinyl acetate copoly-
mer film complying with § 177.1350 of this chapter and used
for packaging meat, fresh fruits, fresh vegetables, and dry
food of Type VIII described in table 1 of § 176.170(c) of this
chapter. The average thickness of such ethylene-vinyl ace-

tate copolymer film shall not exceed 0.003 inch when used
for packaging meat, fresh fruits, and fresh vegetables.
400
Food and Drug Administration, HHS § 178.3130
Alpha-(Carboxymethyl)-omega-(tetradecyloxy)polyoxyethylene) For use only as an antistatic and/or antifogging agent at levels

not to exceed 0.2 pct by weight in polyolefin film not exceed-
ing 0.001 inch thickness.
Alkyl mono- and disulfonic acids, sodium salts (produced from For use only:
n-alkanes in the range of C10-C18 with not less than 50 per- 1. As antistatic agents at levels not to exceed 0.1 percent by
cent C14-C16). weight of polyolefin films that comply with § 177.1520 of this
chapter: Provided, that the finished olefin polymers contact
foods of Types I, II, III, IV, V, VIA, VIB, VII, VIII, and IX de-
scribed in table 1 of § 176.170(c) of this chapter, and under
conditions of use E, F, and G described in table 2 of
§ 176.170(c) of this chapter.
2. As antistatic agents at levels not to exceed 3.0 percent by
weight of polystyrene or rubber-modified polystyrene com-
plying with § 177.1640(c) of this chapter under conditions of
use B through H described in table 2 of § 176.170(c) of this
chapter.
Aluminum Borate ((9Al2O3)·2(B2O3), CAS Reg. No. 11121–16– For use only:
7) produced by reaction between aluminum oxide and/or alu- 1. At levels not to exceed 1 percent by weight of poly-
minum hydroxide with boric acid and/or metaboric acid at propylene films complying with § 177.1520(c) of this chapter,
temperatures in excess of 1000 °C. item 1.1, of polyethylene films complying with § 177.1520(c)
of this chapter, items 2.1 and 2.2 and having a density
greater than 0.94 gram per cubic centimeter, and of
polyolefin copolymer films complying with § 177.1520(c) of
this chapter, items 3.1(a), 3.1(b), 3.2(a), and 3.2(b). The fin-
ished polymers may be used in contact with all food types
identified in Table 1 of § 176.170(c) of this chapter, under
conditions of use A through H as described in Table 2 of
§ 176.170(c) of this chapter. The thickness of the films shall
not exceed 0.005 inch.
2. At levels not to exceed 2 percent by weight of poly-
propylene films complying with § 177.1520(c) of this chapter,
item 1.1, of polyethylene films complying with § 177.1520(c)
of this chapter, items 2.1 and 2.2 and having a density
greater than 0.94 gram per cubic centimeter, and of
polyolefin copolymer films complying with § 177.1520(c) of
this chapter, items 3.1(a), 3.1(b), 3.2(a), and 3.2(b). The fin-
ished polymers may be used in contact with all food types
identified in Table 1 of § 176.170(c) of this chapter under
conditions of use B through H as described in Table 2 of
§ 176.170(c) of this chapter. The thickness of the films shall
N,N-Bis(2-hydroxyethyl)alkyl(C12-C18)amine ............................... For use only as an antistatic agent at levels not to exceed 0.1
pct by weight of polyolefin food-contact films.
N,N-bis(2-hydroxyethyl)alkyl (C13-C15) amine (CAS Reg. No. For use only:
70955–14–5). 1. As an antistatic agent at levels not to exceed 0.2 percent by
weight in molded or extruded high-density polyethylene (hav-
ing a density ≥0.95 g/cm3 and polypropylene containers that
contact food only of the types identified in § 176.170(c) of
this chapter, Table 1, under types I, VI-B, VII-B, and VIII,
under the conditions of use E through G described in Table
2 of § 176.170(c) of this chapter, provided such foods have a
pH above 5.0.
2. As an antistatic agent at levels not to exceed 0.1 percent by
weight in molded or extruded polypropylene homopolymers
and copolymers that contact food only of the types identified
in § 176.170(c) of this chapter, Table 1, under Types II, III,
IV, V, VII-A, and IX, under the conditions of use C through G
described in Table 2 of § 176.170(c) of this chapter.
401
§ 178.3130 21 CFR Ch. I (4–1–11 Edition)
N,N-Bis(2-hydroxyethyl) alkylamine, where the alkyl groups For use only:

(C1-C18) are derived from tallow. 1. As an antistatic agent at levels not to exceed 0.15 pct by
weight in molded or extruded polyethylene containers that
contact food only of the types identified in § 176.170(c) of
this chapter, table 1, under Types I, IV-B, VI-B, VII-B, and
VIII, under the conditions of use E through G described in
table 2 of § 176.170(c) of this chapter provided such foods
have a pH above 5.0.
2. As an antistatic agent at levels not to exceed 0.10 mg. per
square inch of food-contact surface in vinylidene chloride co-
polymer coatings complying with § 175.320, § 177.1200, or
§ 177.1630 of this chapter, provided that such coatings con-
tact food only of the types identified in § 176.170(c) of this
chapter, table 1, under Types I, IV, VII, VIII, and IX under
the conditions of use E through G described in table 2 of
§ 176.170(c) of this chapter. The finished copolymers shall
contain at least 70 weight pct of polymer units derived from
vinylidene chloride; and shall contain not more than 5 weight
pct of total polymer units derived from acrylamide, acrylic
acid, fumaric acid, itaconic acid, methacrylic acid, octadecyl
methacrylate, and vinyl sulfonic acid.
N,N-Bis(2-hydroxyethyl)dodecanamide produced when For use only:
diethanolamine is made to react with methyl laurate such 1. As an antistatic agent at levels not to exceed 0.5 percent by
that the finished product: Has a minimum melting point of 36 weight of molded or extruded polyethylene containers in-
°C; has a minimum amide assay of 90 percent; contains no tended for contact with honey, chocolate syrup, liquid sweet-
more than 2 percent by weight of free diethanolamine; and eners, condiments, flavor extracts and liquid flavor con-
contains no more than 0.5 percent by weight of N,N, bis(2- centrates, grated cheese, light and heavy cream, yogurt, and
hydroxyethyl)piperazine, as determined by paper chroma- foods of Type VIII as described in table 1 of § 176.170(c) of
tography method. this chapter.
2. As an antistatic agent at levels not to exceed 0.2 percent by
weight in polypropylene films complying with § 177.1520 of
this chapter, and used in contact with food of Types I, II, III,
IV, V, VI-B, VII, VIII, and IX described in table 1 of
§ 176.170(c) of this chapter, and under conditions of use B
through H described in table 2 of § 176.170(c) of this chap-
ter. The average thickness of such polypropylene film shall
not exceed 0.001 inches (30 micrometers).
N,N-Bis(2-hydroxyethyl) dodecanamide produced when For use only as an antistatic agent at levels not to exceed 0.5
diethanolamine is made to react with methyl laurate such percent by weight of molded or extruded polyethylene con-
that the finished product: Has a minimum melting point of 36 tainers intended for contact with honey, chocolate syrup, liq-
°C; has a minimum amide assay of 90 percent; contains no uid sweeteners, condiments, flavor extracts and liquid flavor
more than 2 percent by weight of free diethanolamine; and concentrates, grated cheese, light and heavy cream, yogurt,
contains no more than 0.5 percent by weight of N,N′-bis(2- and foods of Type VIII as described in table 1 of
hydroxyethyl) piperazine, as determined by paper chroma- § 176.170(c) of this chapter.
tography method.
N,N-Bis(2-hydroxyethyl) octadecylamine, Chemical Abstracts For use only as an antistatic agent at levels not to exceed 0.45
Service Registry No. 10213–78–2, N-(2-hydroxyethyl)-N- percent by weight in polypropylene films complying with
octadecylglycine (monosodium salt), Chemical Abstracts § 177.1520 of this chapter, and used for packaging food of
Service Registry No. 66810–88–6, and N,N-Bis(2-hydroxy- Types I, II, III, IV, V, VI-B, VII, VIII, and IX described in table
ethyl)-N-(carboxymethyl) octadecanaminum hydroxide (inner 1 of § 176.170(c) of this chapter, and under conditions of use
salt), Chemical Abstracts Service Registry No. 24170–14–7, B through H described in table 2 of § 176.170(c). The aver-
as the major components of a mixture prepared by reacting age thickness of such polypropylene film shall not exceed
ethylene oxide with octadecylamine and further reacting this 0.002 inch.
product with sodium monochloroacetate and sodium hydrox-
ide, such that the final product has: A nitrogen content of
3.3–3.8 percent; a melting point of 42°–50 °C; and a pH of
10.0–11.5 in a 1 percent by weight aqueous solution.
a-n-Dodecanol-omega-hydroxypoly (oxyethylene) produced by For use only as an antistatic agent at levels not to exceed 0.2
the condensation of 1 mole of n-dodecanol with an average pct by weight in low-density polyethylene film having an av-
of 9.5 moles of ethylene oxide to form a condensate having erage thickness not exceeding 0.005 inch.
a hydroxyl content of 2.7 to 2.9 pct and having a cloud point
of 80 °C to 92 °C in 1 pct by weight aqueous solution.
Glycerol ester mixtures of ricinoleic acid, containing not more As an antifogging agent at levels not exceeding 1.5 pct by
than 50 percent monoricinoleate, 45 pct diricinoleate, 10 pct weight of permitted plasticized vinyl chloride homo-and/or
triricinoleate, and 3.3 pct free glycerine. copolymers.
N-Methacryloyloxyethyl-N, N-dimethylammonium-a-N-methyl For use only as an antistatic agent at levels not to exceed 0.2
carboxylate chloride sodium salt, octadecyl methacrylate, percent by weight of polyolefin films that contact foods under
ethyl methacrylate, cyclohexyl methacrylate, N-vinyl-2- the conditions of use B through H described in table 2 of
pyrrolidone copolymer (CAS Reg. No. 66822–60–4). § 176.170(c) of this chapter. The average thickness of such
polyolefin film shall not exceed 0.02 centimeter (0.008 inch).
402
Octadecanoic acid 2-[2-hydroxyethyl) octadecylamino]ethyl For use only as an antistatic agent at levels such that the
ester (CAS Reg. No. 52497–24–2), (octadecylimino) diethyl- product of film thickness in microns times the weight percent
ene distearate (CAS Reg. No. 94945–28–5), and octadecyl additive does not exceed 16, in polypropylene films com-
bis(hydroxyethyl)amine (CAS Reg. No. 10213–78–2), as the plying with § 177.1520(c)1.1 of this chapter, and used for
major components of a mixture prepared by reacting ethyl- packaging food (except for food containing more than 8 per-
ene oxide with octadecylamine and further reacting this prod- cent alcohol) under conditions of use B through H described
uct with octadecanoic acid, such that the final product has: a in table 2 of § 176.170(c) of this chapter.
maximum acid value of 5 mg KOH/g and total amine value
of 86±6 mg KOH/g as determined by a method entitled
‘‘Total Amine Value,’’ which is incorporated by reference.
Copies of the method are available from the Center for Food
Safety and Applied Nutrition (HFS–200), Food and Drug Ad-
ministration, 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/federallregister/
codeloflfederallregulations/ibrllocations.html..
[42 FR 14609, Mar. 15, 1977, as amended at 45 FR 56797, Aug. 26, 1980; 45 FR 85727, Dec. 30, 1980;
46 FR 13688, Feb. 24, 1981; 47 FR 26824, June 22, 1982; 51 FR 28932, Aug. 13, 1986; 56 FR 41457,
Aug. 21, 1991; 58 FR 57556, Oct. 26, 1993; 60 FR 54430, Oct. 24, 1995; 60 FR 18351, Apr. 11, 1995;
62 FR 31511, June 10, 1997; 63 FR 38748, July 20, 1998; 64 FR 62585, Nov. 17, 1999]
§ 178.3280 Castor oil, hydrogenated. (a) The quantity used shall not ex-
Hydrogenated castor oil may be safe- ceed the amount reasonably required
ly used in the manufacture of articles to accomplish the intended technical
or components of articles intended for effect.
use in contact with food subject to the (b) The additive is used as follows:
provisions of this section.
Use Limitations
1. As a lubricant for vinyl chloride polymers used in the manu- For use only at levels not to exceed 4 pct by weight of vinyl
facture of articles or components of articles authorized for chloride polymers.
food-contact use.
2. As a component of cellophane ............................................... Complying with § 177.1200 of this chapter.
3. As a component of resinous and polymeric coatings ............. Complying with § 175.300 of this chapter.
4. As a component of paper and paperboard in contact with Complying with § 176.170 of this chapter.
aqueous and fatty food.
5. As a component of closures with sealing gaskets for food Complying with § 177.1210 of this chapter.
containers.
6. As a component of cross-linked polyester resins ................... Complying with § 177.2420 of this chapter.
7. As a component of olefin polymers complying with For use only at levels not to exceed 2 percent by weight of the
§ 177.1520 of this chapter. polymer.
[42 FR 14609, Mar. 15, 1977, as amended at 55 FR 8914, Mar. 9, 1990]
§ 178.3290 Chromic chloride com- nor exceed 7 micrograms of chromium

plexes. per square inch of closure area.
Myristo chromic chloride complex (b) The packaging container which
and stearato chromic chloride complex has its closure area treated with the
may be safely used as release agents in release agent shall have a capacity of
the closure area of packaging con- not less than 120 grams of food per
tainers intended for use in producing, square inch of such treated closure
manufacturing, packing, processing, area.
preparing, treating, packaging, trans-
porting, or holding food, subject to the § 178.3295 Clarifying agents for poly-
provisions of this section: mers.
(a) The quantity used shall not ex- Clarifying agents may be safely used
ceed that reasonably required to ac- in polymers that are articles or compo-
complish the intended technical effect nents of articles intended for use in
403
§ 178.3295 21 CFR Ch. I (4–1–11 Edition)
contact with food, subject to the provi-

sions of this section:
Aluminum, hydroxybis[2,4,8,10-tetrakis(1,1-dimethylethyl)-6-hy- For use only as a clarifying agent at levels not to exceed 0.25
droxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxidato]- percent by weight of polypropylene and polypropylene co-
(CAS Reg. No. 151841–65–5). polymers complying with § 177.1520(c) of this chapter, items
1.1, 3.1, or 3.2. The finished polymers contact food only of
types I, II, IV-B, VI-B, VII-B, and VIII as identified in Table 1
of § 176.170(c) of this chapter, under conditions of use B
through H described in Table 2 of § 176.170(c) of this chap-
ter or foods only of types III, IV-A, V, VI-A, VI-C, VII-A, and
IX as identified in Table 1 of § 176.170(c) of this chapter,
under conditions of use C through G described in Table 2 of
Bis(p-ethylbenzylidene) sorbitol (CAS Reg. No. 79072–96–1) ... For use only as a clarifying agent at a level not to exceed 0.35
percent by weight of olefin polymers complying with
§ 177.1520(c) of this chapter, items 1.1a, 1.1b, 3.1a, 3.2a, or
3.2b, where the copolymers complying with items 3.1a, 3.2a,
or 3.2b contain not less than 85 weight percent of polymer
units derived from propylene.
Di(p-tolylidene) sorbitol (CAS Reg. No. 54686–97–4) ................ For use only as a clarifying agent at a level not to exceed 0.32
percent by weight in propylene homopolymer complying with
§ 177.1520(c) of this chapter, item 1.1, and in olefin copoly-
mers complying with § 177.1520(c) of this chapter, item 3.1
(containing at least 85 weight percent of polymer units de-
rived from propylene), in contact with all food types under
conditions of use C through G described in table 2 of
Dibenzylidene sorbitol (CAS Reg. No. 32647–67–9) formed by For use only as a clarifying agent for olefin polymers com-
the condensation of two moles of benzaldehyde with one plying with § 177.1520(c) 1.1, 3.1, and 3.2 of this chapter
mole of sorbitol, such that the final product has a minimum under conditions of use C, D, E, F, and G, described in table
content of 95 percent dibenzylidene sorbitol. 2 of § 176.170(c) of this chapter at a level not exceeding
0.25 percent by weight of the polymer.
Dimethyldibenzylidene sorbitol (CAS Reg. No. 135861–56–2) For use only as a clarifying agent at a level not to exceed 0.4
percent by weight of olefin polymers complying with
§ 177.1520(c) of this chapter, items 1.1, 3.1, and 3.2, where
the copolymers complying with items 3.1 and 3.2 contain not
less than 85 weight percent of polymer units derived from
polypropylene. The finished polymers shall be used in con-
tact with food under conditions of use A through H described
in table 2 of § 176.170(c) of this chapter.
Polyvinylcyclohexane (CAS Reg. No. 25498–06–0) ................... For use only as a clarfiying agent for polypropylene complying
with § 177.1520(c) of this chapter, item 1.1., and in pro-
pylene containing copolymers complying with § 177.1520(c)
of this chapter, items 3.1 and 3.2, at a level not exceeding
0.1 percent by weight of the polyolefin.
Sodium di(p-tert-butylphenyl)phosphate (CAS Reg. No. 10491– For use only as a clarifying agent at a level not exceeding 0.35
31–3). parts per hundred of the resin in olefin polymers complying
with § 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2
(where the copolymers complying with items 3.1 and 3.2
contain not less than 85 weight percent of polymer units de-
rived from propylene).
404
Sodium 2,2′-methylenebis(4,6-di-tert-butylphenyl)phosphate For use only:

(CAS Reg. No. 85209–91–2). 1. As a clarifying agent at a level not exceeding 0.30 percent
by weight of olefin polymers complying with § 177.1520(c) of
this chapter, items 1.1, 3.1, or 3.2 (where the copolymers
complying with items 3.1 and 3.2 contain not less than 85
weight percent of polymer units derived from polypropylene).
The finished polymers contact foods only of types I, II, IV-B,
VI-B, VII-B, and VIII as identified in table 1 of § 176.170(c) of
this chapter and limited to conditions of use B through H, de-
scribed in table 2 of § 176.170(c), or foods of all types, lim-
ited to conditions of use C through H described in table 2 of
§ 176.170(c).
2. As a clarifying agent at levels not exceeding 0.10 percent by
weight of polypropylene complying with § 177.1520(c) of this
chapter, items 1.1(a) or 1.1(b) and of olefin polymers com-
plying with § 177.1520(c) of this chapter, items 3.1(a), 3.1(b),
3.1(c), 3.2(a), or 3.2(b) (where the copolymers contain not
less than 85 weight percent of the polymer units derived
from polypropylene.) The finished polymers shall be used in
contact with foods only under conditions of use A through H
described in Table 2 of § 176.170(c) of this chapter.
3. As a clarifying agent at a level not exceeding 0.30 percent
by weight of olefin polymers complying with § 177.1520(c) of
this chapter, item 2.2, where the finished polymer contacts
food only of types I, II, IV-B, VI-A, VI-B, and VII-B as identi-
fied in Table 1 of § 176.170(c) of this chapter, and limited to
conditions of use B through H described in Table 2 of
§ 176.170(c) of this chapter, or foods of types III, IV-A, V, VI-
C, and VII-A as identified in Table 1 of § 176.170(c) of this
chapter and limited to conditions of use C through G de-
scribed in Table 2 of § 176.170(c) of this chapter.
[46 FR 59236, Dec. 4, 1981, as amended at 52 FR 30920, Aug. 18, 1987; 53 FR 30049, Aug. 10, 1988;
54 FR 12432, Mar. 27, 1989; 54 FR 14734, Apr. 12, 1989; 55 FR 52990, Dec. 26, 1990; 56 FR 1085, Jan.
11, 1991; 59 FR 13650, Mar. 23, 1994; 59 FR 25323, May 16, 1994; 61 FR 33847, July 1, 1996; 61 FR
51588, Oct. 3, 1996; 61 FR 65943, Dec. 16, 1996; 63 FR 56789, Oct. 23, 1998; 63 FR 68392, Dec. 11,
1998; 64 FR 26843, May 18, 1999; 65 FR 16316, Mar. 28, 2000]
§ 178.3297 Colorants for polymers. (b) The colorant must be used in ac-
cordance with current good manufac-
The substances listed in paragraph
turing practice, including use levels
(e) of this section may be safely used as
which are not in excess of those reason-
colorants in the manufacture of arti-
ably required to accomplish the in-
cles or components of articles intended
tended coloring effect.
for use in producing, manufacturing,
packing, processing, preparing, treat- (c) Colorants in this section must
ing, packaging, transporting, or hold- conform to the description and speci-
ing food, subject to the provisions and fications indicated. If a polymer de-
definitions set forth in this section: scribed in this section is itself the sub-
ject of a regulation promulgated under
(a) The term colorant means a dye,
section 409 of the Federal Food, Drug,
pigment, or other substance that is
and Cosmetic Act, it shall also comply
used to impart color to or to alter the
with any specifications and limitations
color of a food-contact material, but
prescribed by that regulation. Extrac-
that does not migrate to food in
tion testing guidelines to conduct stud-
amounts that will contribute to that
ies for additional uses of colorants
food any color apparent to the naked
eye. For the purpose of this section, under this section are available from
the term ‘‘colorant’’ includes sub- the Food and Drug Administration free
stances such as optical brighteners and of charge from the Center for Food
fluorescent whiteners, which may not Safety and Applied Nutrition, (HFS–
themselves be colored, but whose use is 200) Food and Drug Administration,
intended to affect the color of a food- 5100 Paint Branch Pkwy., College Park,
contact material. MD 20740.
405
§ 178.3297 21 CFR Ch. I (4–1–11 Edition)
(d) Color additives and their lakes chapter, may also be used as colorants
listed for direct use in foods, under the for food-contact polymers.
provisions of the color additive regula- (e) List of substances:
tions in parts 73, 74, 81, and 82 of this
Aluminum.
Aluminum hydrate.
Aluminum and potassium silicate (mica).
Aluminum mono-, di-, and tristearate.
Aluminum silicate (China clay).
4-[[5-[[[4-(Aminocarbonyl) phenyl] amino]carbonyl]- 2- For use at levels not to exceed 1 percent by weight of poly-
methoxyphenyl]azo]-N-(5-chloro-2,4-dimethoxyphenyl)-3-hy- mers. The finished articles are to contact foods only under
droxy-2-naphthalene-carboxamide (C.I. Pigment Red 187, conditions of use B through H described in table 2 of
CAS Reg. No. 59487–23–9). § 176.170(c) of this chapter.
N-[4-(Aminocarbonyl)phenyl]-4-[[1-[[(2,3-dihydro-2-oxo-1H- For use at levels not to exceed 1 percent by weight of poly-
benzimidazol-5-yl)amino]carbonyl]-2- mers. The finished articles are to contact food only under
oxopropyl]azo]benzamide (C. I. Pigment Yellow 181, CAS conditions of use B through H described in table 2 of
Reg. No. 74441–05–7). § 176.170(c) of this chapter.
Anthra(2,1,9-def:(6,5,10-d′e′f)diisoquinoline-1,3,8,10(2H,9H)- For use at levels not to exceed 1% by weight of polymers. The
tetrone (C.I. Pigment Violet 29; CAS Reg. No. 81–33–4). finished articles are to contact food only under conditions of
use B through H as described in Table 2 of § 176.170(c) of
this chapter.
Barium sulfate.
Bentonite.
Bentonite, modified with 3-dimethyldioctadecylammonium ion.
1,4-Bis[(2,4,6-trimethylphenyl)amino]-9,10-anthracenedione For use at levels not to exceed 0.0004 percent by weight of
(CAS Reg. No. 116–75–6). polyethylene phthalate polymers complying with § 177.1630
of this chapter.
3,6-Bis(4-chlorophenyl)-2,5-dihydro-pyrrolo[3,4-c]pyrrole-1,4- For use only at levels not to exceed 1 percent by weight of
dione (C.I. Pigment Red 254, CAS Reg. No. 84632–65–5). polymers. The finished articles are to contact food only
under conditions of use B through H, described in table 2 of
4,4′-Bis(4-anilino-6-diethanolamine-a-triazin-2-ylamino)-2,2′-stil- For use only in the textile fibers specified in § 177.2800 of this
bene disulfonic acid, disodium salt. chapter.
4,4′-Bis(4-anilino-6-methylethanolamine-a-triazin-2-ylamino)- Do.
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-sulfophenyl)-1H-pyrazol-4- For use at levels not to exceed 1.0 percent by weight of the
yl]azo]-5-methylbenzenesulfonic acid, calcium salt (1:1); (C.I. finished polymers. The finished articles are to contact food
Pigment Yellow 191, CAS Reg. No. 129423–54–7). only under conditions of use B through H as described in
table 2 of § 176.170(c) of this chapter.
4-Chloro-2-[[5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H-pyrazol-4- For use at levels not to exceed 0.5 percent by weight of poly-
yl]azo]-5-methylbenzenesulfonic acid, diammonium salt (1:2): mers. The finished articles are to contact food under condi-
(C.I. Pigment Yellow 191:1, CAS Reg. No. 154946–66–4). tions of use A through H described in Table 2 of
Chrome antimony titanium buff rutile (C.I. Pigment Brown 24, For use at levels not to exceed 1 percent by weight of poly-
CAS Reg. No. 68186–90–3). mers. The finished articles are to contact food only under
Chromium oxide green, Cr2O3 (C.I. Pigment Green 17, C.I. No. For use only:
77288). 1. In polymers used in contact with food at a level not to ex-
ceed 5 percent by weight of the polymer, except as specified
below.
2. In olefin polymers complying with § 177.1520 of this chapter.
3. In repeat-use rubber articles complying with § 177.2600 of
this chapter; total use is not to exceed 10 percent by weight
of rubber articles.
406
Cobalt aluminate .......................................................................... For use only:

1. In resinous and polymeric coatings complying with § 175.300
of this chapter.
2. Melamine-formaldehyde resins in molded articles complying
with § 177.1460 of this chapter.
3. Xylene-formaldehyde resins condensed with 4-
4′isopropylidenediphenol-epichlorohydrin epoxy resins com-
plying with § 175.380 of this chapter.
4. Ethylene-vinyl acetate copolymers complying with
§ 177.1350 of this chapter.
5. Urea-formaldehyde resins in molded articles complying with
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 § 176.170(c) of this
chapter.
Copper chromite black spinel (C.I. Pigment Black 28, CAS For use at levels not to exceed 5 percent by weight of poly-
Reg. No. 68186–91–4). mers. The finished articles are to contact food only under
conditions of use A through H as described in table 2 of
D&C Red No. 7 and its lakes.
Diatomaceous earth.
4,4′-Diamino-[1,1′-bianthracene]-9,9′,10,10′-tetrone (CAS Reg. For use at levels not to exceed 1 percent by weight of poly-
No. 4051–63–2). mers. The finished articles are to contact food only under
conditions of use B through H described in table 2 of
2,9-Dichloro-5,12-dihydroquinone[2,3-b]acridine-7,14-dione (C.I. For use at levels not to exceed 1.0 percent by weight of poly-
Pigment Red 202, CAS Reg. No. 3089–17–6). mers.
4,5-Dichloro-2-((5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H- For use only:
pyrazol-4- yl)azo)benzenesulfonic acid, calcium salt(1:1), 1. At levels not to exceed 1 percent by weight of polypropylene
(C.I. Pigment Yellow 183, CAS Reg. No. 65212–77–3). polymers and copolymers complying with § 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 § 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
§ 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 § 176.170(c) of this chapter.
5-[(2,3-Dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]- For use at levels not to exceed 1 percent by weight of poly-
2,4,6(1H, 3H, 5H)-pyrimidinetrione (CAS Reg. No. 72102– mers. The finished articles are to contact food only under
84–2). conditions of use B through H described in table 2 of
2,9-Dimethylanthra(2,1,9-def:6,5,10-d′e′f′)diisoquinoline- For use at levels not to exceed 1 percent by weight of poly-
1,3,8,10(2H,9H)-tetrone (C.I. Pigment Red 179, CAS Reg. mers. The finished articles are to contact food only under
No. 5521–31–3). conditions of use B through H as described in Table 2 of
3,3′-[(2,5-Dimethyl-1,4-phenylene)bis[imino(1-acetyl-2-oxo-2,1- For use at levels not to exceed 1 percent by weight of poly-
ethanediyl)azo]]bis[4-chloro-N-(5-chloro-2-methylphenyl)- mers. The finished articles are to contact food only under
benzamide] (CAS Reg. No. 5280–80–8). conditions of use B through H described in table 2 of
3,3′-[(2,5-Dimethyl-1,4-phenylene)bis[imino-carbonyl(2-hydroxy- For use at levels not to exceed 1 percent by weight of poly-
3,1-naphthalenediyl) azo]] bis(4-methylbenzoic acid), bis(2- mers. The finished articles are to contact food only under
chloroethyl) ester (CAS Reg. No. 68259–05–2). conditions of use B through H described in table 2 of
2,2′-[1,2-Ethanediylbis(oxy-2,1-phenyleneazo)]bis[N-(2,3- For use at levels not to exceed 1.0 percent by weight of poly-
dihydro-2-oxo-1H-benzimidazol-5-yl)]-3-oxo-butanamide (C.I. mers. The finished articles are to contact food only under
Pigment Yellow 180, CAS Reg. No. 77804–81–0). conditions of use B through G described in table 2 of
2,2′-(1,2-Ethenediyldi-4,1-phenylene) bis(benzoxazole) (CAS For use as an optical brightener for all polymers at a level not
Reg. No. 1533–45–5). to exceed 0.025 percent by weight of polymer. The finished
polymer shall contact foods only of the types identified in
table 1 of § 176.170(c) of this chapter, under categories I, II,
IV-B, VI-A, VI-B, VII-B, and VIII at temperatures not to ex-
ceed 275 °F.
407
§ 178.3297 21 CFR Ch. I (4–1–11 Edition)
High-purity furnace black (CAS Reg. No. 1333–86–4) con- For use at levels not to exceed 2.5 percent by weight of the
taining total polynuclear aromatic hydrocarbons not to ex- polymer.
ceed 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 incor-
porated 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 exam-
ined at the Center for Food Safety and Applied Nutrition’s Li-
brary, 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/
federallregister/codeloflfederallregulations/
ibrllocations.html..
Iron oxides.
Kaolin-modified, produced by treating kaolin with a reaction For use only in olefin polymers complying with § 177.1520 of
product of isopropyl titanate and oleic acid in which 1 mole this chapter at levels not to exceed 40 percent by weight of
of isopropyl titanate is reacted with 1 to 2 moles of oleic olefin polymer.
acid. The reaction product will not exceed 8 percent of the
modified kaolin. The oleic acid used shall meet the require-
ments specified in § 172.860 of this chapter.
Magnesium oxide.
Magnesium silicate (talc).
Manganese Violet (manganese ammonium pyrophosphate; For use at levels not to exceed 2 percent by weight of poly-
CAS Reg. No. 10101–66–3).. mers. The finished articles are to contact food only under
conditions of use A through H as described in table 2 of
Mixed methylated 4,4′-bis(2-benzoxazolyl)stilbenes with the For use as an optical brightener only at levels not to exceed
major portion consisting of 4-(2-benzoxazolyl)-4′-(5-methyl-2- 0.05 percent by weight of rigid and semirigid polyvinyl chlo-
benzoxazolyl)stilbene (CAS Registry No. 5242–49–9) and ride and not to exceed 0.03 percent by weight in all other
lesser portions consisting of 4,4′-bis(5-methyl-2- polymers. The finished food-contact articles shall be used
benzoxazolyl)stilbene (CAS Registry No. 2397–00–4) and only under conditions of use D, E, F, and G described in
4,4′-bis(2-benzoxazolyl)stilbene (CAS Registry No. 1533–45– table 2 of § 176.170(c) of this chapter.
5).
7-(2H-Naphtho[1,2-d]triazol-2-yl)-3-phenylcoumarin (CAS Reg. For use as an optical brightener only in:
No. 3333–62–8) having a melting point of 250 °C to 251 °C 1. Olefin polymers complying with § 177.1520 of this chapter
and a nitrogen content of 10.7 to 11.2 percent. 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 § 177.1520(c) of this chapter. The
polymer may be used under the conditions described in
§ 176.170(c) of this chapter, table 2, under conditions of use
E, F, and G.
2. Polyethylene terephthalate specified in § 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 (C.I. Pigment Yellow 53, For use at levels not to exceed 1 percent by weight of poly-
CAS Reg. No. 8007–18–9). mers. The finished articles are to contact food only under
1,1′-[(6-Phenyl-1,3,5-triazine-2,4-diyl)diimino]bis-9,10- For use at levels not to exceed 0.25 percent by weight of poly-
anthracenedione (CAS Reg. No. 4118–16–5). ethylene phthalate polymers that comply with § 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,
§ 176.170(c) of this chapter, except, when such articles are
used with food types III, IV-A, and V, described in table 1,
§ 176.170(c) of this chapter, the finished articles are to con-
tact 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
§ 177.2600 of this chapter; total use is not to exceed 10 per-
cent by weight of rubber article.
408
Quinacridone red (C.I. Pigment violet 19, C.I. No. 73900).

Sienna (raw and burnt).
Silica.
2,3,4,5-Tetrachloro-6-cyanobenzoic acid, methyl ester reaction For use only at levels not to exceed 1 percent by weight of
products with p-phenyllenediamine and sodium methoxide polymers. The finished articles are to contact food only
(CAS reg. No. 106276–80–6). under conditins of use B through H, described in table 2, of
4,5,6,7-Tetrachloro-2-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3- For use only at levels not to exceed 1 percent by weight of
dioxo-1H-inden-2-yl)-8-quinolinyl]-1H-isoindole-1,3(2H)-dione polymers. The finished articles are to contact food only
(C. I. Pigment Yellow 138, CAS Reg. No.30125–47–4). under conditions of use C through H, as described in table 2
of § 176.170(c) of this chapter; provided further that the fin-
ished articles shall not be filled at temperatures exceeding
158 °F (70 °C).
2,2′-(2,5-Thiophenediyl)-bis(5-tert-butylbenzoxazole) (CAS Reg. For use as an optical brightener:
No. 7128–64–5). 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
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 § 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 de-
scribed in table 2 of § 176.170(c) of this chapter.
3. In adhesives complying with § 175.105 of this chapter and in
pressure-sensitive adhesives complying with § 175.125 of
this chapter.
Titanium dioxide.
Titanium dioxide-barium sulfate.
Titanium dioxide-magnesium silicate.
Ultramarines ................................................................................ As identified in § 73.2725 of this chapter.
Zinc carbonate ............................................................................. For use only:
of this chapter.
2. Melamineformaldehyde resins in molded articles complying
3. Xylene-formaldehyde resins condensed with 4-4′-
isopropylidene diphenol-epichlorohydrin epoxy resins com-
Zinc chromate .............................................................................. For use only in rubber articles for repeated use complying with
§ 177.2600 of this chapter; total use is not to exceed 10 per-
cent by weight of rubber article.
Zinc oxide .................................................................................... For use only:
of this chapter.
2. Melamine-formaldehyde resins in molded articles complying
3. Xylene-formaldehyde resins condensed with 4-4′-
isopropylidene-diphenol-epichlorohydrin epoxy resins com-
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 § 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.
409
§ 178.3300 21 CFR Ch. I (4–1–11 Edition)
§ 178.3300 Corrosion inhibitors used List of substances Limitations

for steel or tinplate.
Propylene glycol.
Corrosion inhibitors may be safely
used for steel or tinplate intended for § 178.3400 Emulsifiers and/or surface-
use in, or to be fabricated as, food con- active agents.
tainers or food-processing or handling
The substances listed in paragraph
equipment, subject to the provisions of
(c) of this section may be safely used as
this section.
emulsifiers and/or surface-active
(a) The corrosion inhibitors are pre- agents in the manufacture of articles
pared from substances identified in this or components of articles intended for
section and used subject to the limita- use in producing, manufacturing, pack-
tions prescribed. ing, processing, preparing, treating,
(b) The following corrosion inhibitors packaging, transporting, or holding
or adjuvants are used in amounts not food, subject to the provisions of this
to exceed those reasonably required to section.
accomplish the intended physical or (a) The quantity used shall not ex-
technical effect: ceed the amount reasonably required
(1) Corrosion inhibitors (active ingre- to accomplish the intended technical
dients) used in packaging materials for effect; and the quantity that may be-
the packaging of steel or tinplate or ar- come a component of food as a result of
ticles fabricated therefrom: such use shall not be intended to, nor
in fact, accomplish any physical or
technical effect in the food itself.
Dicyclohexylamine and its salts of (b) The use as an emulsifier and/or
fatty acids derived from animal surface-active agent in any substance
or vegetable oil. or article that is the subject of a regu-
Dicyclohexylamine nitrite.
Morpholine and its salts of fatty
lation in parts 174, 175, 176, 177, 178 and
acids derived from animal or § 179.45 of this chapter conforms with
vegetable oils. any specifications and limitations pre-
scribed by such regulation for the fin-
(2) Adjuvants employed in the appli- ished form of the substance or article.
cation and use of corrosion inhibitors: (c) List of substances:
a-Alkyl-, a-alkenyl-, and a-alkylaryl-omega- For use only at levels not to exceed 0.5 pct by weight of coat-
hydroxypoly(oxyethylene) mixture consisting of 30 weight pct ings complying with § 175.320 of this chapter and limited to
of a-(2,4,6-triisobutylphenyl)-omega- use as an emulsifier for polyhydric alcohol diesters used as
hydroxypoly(oxyethylene) having an average provided in § 178.3770(b). The weight of the finished coating
poly(oxyethylene) content of 7 moles and 70 weight pct of a shall not exceed 2 milligrams per square inch of food-contact
1:1 weight ratio mixture of a-(Z)-9-octadecenyl-omega- surface.
hydroxypoly(oxyethylene) having an average
poly(oxyethylene) content of 18 moles and a-alkyl(C16-C18)-
omega-hydroxypoly(oxyethylene) having an average
poly(oxyethylene) content of 18 moles.
n-Alkylbenzenesulfonic acid (alkyl group consisting of not less For use only as emulsifiers and/or surface active agents as
than 95 percent C10 to C16) and its ammonium, calcium, components of nonfood articles complying with §§ 175.300,
magnesium, potassium, and sodium salts. 175.320, 175.365, 175.380, 176.170, 176.180, 177.1010,
177.1200, 177.1210, 177.1630, 177.2600, and 177.2800 of
this chapter and § 178.3120.
410
Alkyl mono- and disulfonic acids, sodium salts (produced from For use only:
n-alkanes in the range of C10-C18 with not less than 50 per- 1. As provided in § 176.170 of this chapter.
cent C14-C16). 2. At levels not to exceed 2 percent by weight of polyvinyl
chloride and/or vinyl chloride copolymers complying with
3. As emulsifiers in vinylidene chloride copolymer or
homopolymer coatings at levels not to exceed a total of 2.6
percent by weight of coating solids. The finished polymer
contacts food only of the Types I, II, III, IV, V, VIA, VIB, VII,
VIII, and IX as identified in table 1 of § 176.170(c) of this
chapter, and limited to conditions of use E, F, and G de-
scribed in table 2 of § 176.170 of this chapter.
4. As emulsifiers and/or surface-active agents at levels not to
exceed 3.0 percent by weight of polystyrene or rubber-modi-
fied polystyrene complying with § 177.1640(c) of this chapter
under conditions of use B through H described in table 2 of
a-Alkyl-omega-hydroxypoly(oxyethylene) produced by con-
densation of 1 mole of C11-C15 straight-chain randomly
substitued secondary alcohols with an average of 7–20
moles of ethylene oxide.
alpha Olefin sulfonate [alkyl group is in the range of C10-C18 For use only:
with not less than 50 percent C14-C16], ammonium, calcium, 1. In acrylonitrile-butadiene copolymers identified in
magnesium, potassium, and sodium salts. § 177.2600(c)(4)(i) of this chapter.
2. At levels not to exceed 1 percent by weight of acrylic coat-
ings complying with § 175.300(b)(3)(xx) of this chapter and
having a maximum thickness of 0.051 millimeter (0.002
inch). The finished polymers contact food only of the Types
V, VIII, and IX as identified in table 1 of § 176.170(c) of this
chapter.
3. At levels not to exceed 2 percent by weight of vinyl chloride
copolymer coatings having a maximum thickness of 0.051
millimeter (0.002 inch) and complying with
§ 175.300(b)(3)(xv) of this chapter. The finished polymers
contact food only of the Types V, VIII, and IX as identified in
4. As provided in § 175.105 of this chapter.
Alpha-sulfo-omega-(dodecyloxy)poly(oxyethylene) ammonium For use only as an emulsifier at levels not to exceed 0.3 per-
salt (CAS Reg. No. 32612–48–9). cent by weight of styrene-butadiene copolymer coatings for
paper and paperboard complying with § 176.170 of this
chapter.
Ammonium salt of epoxidized oleic acid, produced from For use only:
epoxidized oleic acid (predominantly dihydroxystearic and 1. As a polymerization emulsifier at levels not to exceed 1.5
acetoxyhydroxystearic acids) meeting the following specifica- pct by weight of vinyl chloride polymers used as components
tions: Acid number 160–180, saponification number 210– of nonfood articles complying with §§ 175.105, 175.300,
235, iodine number 2–15, and epoxy groups 0–0.4 percent. 176.170, 176.180, and 177.1210 of this chapter. Such vinyl
chloride polymers are limited to polyvinyl chloride and/or
vinyl chloride copolymers complying with § 177.1980 of this
chapter.
2. As a polymerization emulsifier at levels not to exceed 1.5
pct by weight of vinyl chloride-vinyl acetate copolymers used
as components of nonfood articles complying with
§§ 175.105, 175.300, 176.170, 176.180, and 177.1210 of this
chapter.
Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium For use as a surface active agent as provided in §§ 175.105,
salt (also known as butanedioic acid, sulfo-1,4-diisodecyl 175.125, 176.170, and 176.180 of this chapter.
ester, ammonium salt [CAS Reg. No. 144093–88–9])..
a-Di-sec-butylphenyl-omega-hydroxypoly(oxyethylene) pro-
duced by the condensation of 1 mole of di-sec-butylphenol
with an average of 4–14 or 30–50 moles of ethylene oxide; if
a blend of products is used, the average number of moles of
ethylene oxide reacted to produce any product that is a com-
ponent of the blend shall be in the range 4–14 or 30–50;
sec-butyl groups are predominantly (90 percent or more) o-,
p-substituents.
Disodium 4-isodecyl sulfosuccinate (CAS Reg. No. 37294–49– For use only as an emulsifier at levels not to exceed 5 percent
8). by weight of polymers intended for use in coatings.
a-Dodecyl-omega-hydroxpoly (oxyethylene) mixture of dihydro-
gen phosphate and monohydrogen phosphate esters that
have an acid number (to pH 5.2) of 103–111 and that are

produced by the esterification of the condensation product of
1 mole of n-dodecyl alcohol with 4–4.5 moles of ethylene
oxide.
411
§ 178.3400 21 CFR Ch. I (4–1–11 Edition)
a-(p-Dodecylphenyl)-omega-hydroxypoly (oxyethylene) pro-

duced by the condensation of 1 mole of dodecylphenol
(dodecyl group is a propylene tetramer isomer) with an aver-
age of 4–14 or 30–50 moles of ethylene oxide; if a blend of
products is used, the average number of moles of ethylene
oxide reacted to produce any product that is a component of
the blend shall be in the range 4–14 or 30–50.
Naphthalene sulfonic acid-formaldehyde condensate, sodium For use only:
salt (CAS Reg. No. 9084–06–4). 1. At levels not to exceed 10 micrograms/in2 (0.16 mg/dm2) in
vinylidene chloride copolymer or homopolymer coatings ap-
plied to films of propylene polymers complying with
2. At levels not to exceed 14 micrograms/in2 (0.21 mg/dm2) in
vinylidene chloride copolymer or homopolymer coatings ap-
plied to films of polyethylene phthalate polymers complying
a-(p-nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of
dihydrogen phosphate and monohydrogen phosphate esters
that have an acid number (to pH 5.2) of 49–59 and that are
produced by the esterification of a-(p-nonylphenyl)-omega-
hydroxypoly (oxyethylene) complying with the identity pre-
scribed in § 178.3400(c) and having an average
poly(oxyethylene) content of 5.5–6.5 moles.
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of
produced by the esterification of ′-(p-nonylphenyl)omega-
poly(oxyethylene) content of 9–10 moles.
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of
produced by the esterification of a-(p-nonylphenyl)-omega-
poly(oxyethylene) content of 45–55 moles.
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) produced
by the condensation of 1 mole of nonylphenol (nonyl group
is a propylene trimer isomer) with an average of 4–14 or 30–
50 moles of ethylene oxide: if a blend of products is used,
the average number of moles of ethylene oxide reacted to
produce any product that is a component of the blend shall
be in the range 4–14 or 30–50.
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) sulfate,
ammonium or sodium salt: the nonyl group is a propylene
trimer isomer and the poly (oxyethylene) content average 4
moles.
Polyethyleneglycol alkyl(C10-C12) ether sulfosuccinate, disodium For use only at levels not to exceed 5 percent by weight of
salt (CAS Reg. No. 68954–91–6). total monomers used in the emulsion polymerization of poly-
vinyl acetate, acrylic, and vinyl/acrylic polymers intended for
use as coatings for paper and paperboard.
Poly[(methylene-p-nonylphenoxy) poly(oxypropylene)(4–12 For use in coatings at levels not to exceed 1 mg per square
moles) propanol] of minimum molecular weight 3500. foot of food-contact surface.
Poly(oxypropylene) (45–48 moles) block polymer with For use only as a surface-active agent at levels not to exceed
poly(oxyethylene). The finished block polymers meet the fol- 0.5 percent by weight of polyolefin film or polyolefin coatings.
lowing specifications: Average molecular weight 11,000– Such polyolefin film and polyolefin coatings shall have an av-
18,000; hydroxyl number 6.2–10.2; ·cloud point above 100 erage thickness not to exceed 0.005 inch and shall be lim-
°C. for 10 pct solution. ited to use in contact with foods that have a pH above 5.0
and that contain no more than 8 pct of alcohol.
Polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate)
meeting the following specifications: Saponification number
40–50, acid number 0–2, hydroxyl number 60–108, oxy-
ethylene content 70–74 pct.
Polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate)
meeting the following specifications: Saponification number
41–52, oxyethylene content 66–70.5 pct.
Polysorbate 60 conforming to the identity prescribed in

412
Polysorbate 85 (polyoxyethylene (20) sorbitan trioleate) meet-

ing the following specifications: Saponification number 80–
95, oxyethylene content 46–50 percent.
Sodium 1,4-dicylcohexyl sulfosuccinate.
Sodium 1,4-dihexyl sulfosuccinate.
Sodium 1,4 diisobutyl sulfosuccinate.
Sodium dioctyl sulfosuccinate.
Sodium 1,4-dipentyl sulfosuccinate.
Sodium 1,4-ditridecyl sulfosuccinate.
Sodium lauryl sulfate.
Sodium monoalkylphenoxybenzenedisulfonate and sodium
dialkylphenoxybenzenedisulfonate mixtures containing not
less than 70 pct of the monoalkylated product where the
alkyl group is C8C16.
Sorbitan monolaurate meeting the following specifications. Sa-
ponification number 153–170; and hydroxyl number 330–360.
Sorbitan monooleate meeting the following specifications: Sa-
ponification number 145–160, hydroxyl number 193–210.
Sorbitan monopalmitate meeting the following specifications:
Saponification No. 140–150; and hydroxyl No. 275–305.
Sorbitan monostearate conforming to the identity prescribed in
Sorbitan trioleate meeting the following specifications: Saponi-
fication No. 170–190; and hydroxyl No. 55–70.
Sorbitan tristearate meeting the following specifications: Sa-
ponification No. 176–188; and hydroxyl No. 66–80.
Sulfosuccinic acid 4-ester with polyethylene glycol dodecyl For use only at levels not to exceed 5 percent by weight of
ether, disodium salt (CAS Reg. No. 39354–45–5). total monomers used in the emulsion polymerization of poly-
vinyl acetate, acrylic, and vinyl/acrylic polymers intended for
use as coatings for paper and paperboard.
Sulfosuccinic acid 4-ester with polyethylene glycol nonylphenyl For use only at levels not to exceed 5 percent by weight of the
ether, disodium salt (alcohol moiety produced by condensa- total coating monomers used in the emulsion polymerization
tion of 1 mole nonylphenol and an average of 9–10 moles of of polyvinyl acetate and vinyl-acrylate copolymers intended
ethylene oxide) (CAS Reg. No. 9040–38–4). for use as coatings for paper and paperboard.
a-[p-(1,1,3,3-Tetramethylbutyl)phenyl] omega-
hydroxypoly(oxyethylene) produced by the condensation of 1
mole of p-(1,1,3,3-tetramethylbutyl) phenol with an average
of 4–14 or 30–40 moles of ethylene oxide; if a blend of prod-
ucts is used, the average number of moles of ethylene oxide
reacted to produce any product that is a component of the
blend shall be in the range 4–14 or 30–50.
Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecyl-sulfosuccinate For use only as a polymerization emulsifier for resins applied
to tea-bag material.
a-Tridecyl-omega-hydroxypoly (oxyethylene) mixture of di-
hydrogen phosphate and monohydrogen phosphate esters
one mole of ‘‘oxo’’ process tridecyl alcohol with 5.5–6.5
moles of ethylene oxide.
a-Tridecyl-omega-hydroxypoly (oxyethyl-ene) mixture of di-
hydrogen phosphate and monohydrogen phosphate esters
one mole of ‘‘oxo’’ process tridecyl alcohol with 9–10 moles
of ethylene oxide.
(d) The provisions of this section are Finding Aids section of the printed volume
not applicable to emulsifiers and/or and at www.fdsys.gov.
surface-active agents listed in
§ 178.3450 Esters of stearic and pal-
§ 175.105(c)(5) of this chapter and used in
mitic acids.
food-packaging adhesives complying
with § 175.105 of this chapter. The ester stearyl palmitate or
palmityl stearate or mixtures thereof
[42 FR 14609, Mar. 15, 1977] may be safely used as adjuvants in
EDITORIAL NOTE: For FEDERAL REGISTER ci- food-packaging materials when used in
tations affecting § 178.3400, see the List of accordance with the following pre-
CFR Sections Affected, which appears in the scribed conditions:
413
§ 178.3480 21 CFR Ch. I (4–1–11 Edition)
(a) They are used or intended for use www.archives.gov/federallregister/

as plasticizers or lubricants in poly- codeloflfederallregulations/
styrene intended for use in contact ibrllocations.html.
with food. (1) Synthetic fatty alcohols. (i) Hexyl,
(b) They are added to the formulated octyl, decyl, lauryl, myristyl, cetyl,
polymer prior to extrusion. and stearyl alcohols meeting the speci-
(c) The quantity used shall not ex- fications and definition prescribed in
ceed that required to accomplish the § 172.864 of this chapter, except that
intended technical effect. they may contain not more than 0.8
weight percent total diols.
§ 178.3480 Fatty alcohols, synthetic. (ii) Lauryl, myristyl, cetyl, and ste-
Synthetic fatty alcohols may be safe- aryl alcohols manufactured by the
ly used as components of articles in- process described in § 172.864(a)(2) of
tended for use in contact with food, this chapter such that lauryl and
and in synthesizing food additives and myristyl alcohols meet the specifica-
other substances permitted for use as tions in § 172.864(a)(1)(i) of this chapter,
components of articles intended for use and cetyl and stearyl alcohols meet the
in contact with food in accordance specifications in § 172.864(a)(1)(ii) of this
with the following prescribed condi- chapter.
tions: (2) Conditions of use. (i) Synthetic
(a) The food additive consists of fatty fatty alcohols as substitutes for the
alcohols meeting the specifications and corresponding naturally derived fatty
definition prescribed in § 172.864 of this alcohols permitted for use in compli-
chapter, except as provided in para- ance with § 178.3910.
graph (c) of this section. (ii) Synthetic lauryl alcohol as a sub-
(b) It is used or intended for use as stitute for the naturally derived lauryl
follows: alcohol permitted as an intermediate
(1) As substitutes for the cor- in the synthesis of sodium lauryl sul-
responding naturally derived fatty al- fate used in compliance with § 178.3400.
cohols permitted for use as components
of articles intended for use in contact [42 FR 14609, Mar. 15, 1977, as amended at 47
with food by existing regulations in FR 11847, Mar. 19, 1982; 54 FR 24898, June 12,
1989]
parts 174, 175, 176, 177, 178 and § 179.45 of
this chapter: Provided, That the use is § 178.3500 Glycerin, synthetic.
in compliance with any prescribed lim-
itations. Synthetic glycerin may be safely
(2) As substitutes for the cor- used as a component of articles in-
responding naturally derived fatty al- tended for use in packaging materials
cohols used as intermediates in the for food, subject to the provisions of
synthesis of food additives and other this section:
substances permitted for use as compo- (a) It is produced by the hydro-
nents of food-contact articles. genolysis of carbohydrates, and shall
(c) Synthetic fatty alcohols identi- contain not in excess of 0.2 percent by
fied in paragraph (c)(1) of this section weight of a mixture of butanetriols.
may contain not more than 0.8 weight (b) It is used in a quantity not to ex-
percent of total diols as determined by ceed that amount reasonably required
a method titled ‘‘Diols in Monohydroxy to produce its intended physical or
Alcohol by Miniature Thin Layer Chro- technical effect, and in accordance
matography (MTLC),’’ which is incor- with any limitations prescribed by ap-
porated by reference. Copies are avail- plicable regulations in parts 174, 175,
able from the Center for Food Safety 176, 177, 178 and 179 of this chapter. It
and Applied Nutrition (HFS–200), Food shall not be intended to, nor in fact ac-
and Drug Administration, 5100 Paint complish, any direct physical or tech-
Branch Pkwy., College Park, MD 20740, nical effect in the food itself.
or available for inspection at the Na-
tional Archives and Records Adminis- § 178.3505 Glyceryl tri-(12-acetoxy-
tration (NARA). For information on stearate).

the availability of this material at Glyceryl tri-(12-acetoxystearate)
NARA, call 202–741–6030, or go to: http:// (CAS Reg. No. 139–43–5) may be safely
414
used as a component of articles in- § 178.3520 Industrial starch-modified.

tended for use in producing, manufac- Industrial starch-modified may be
turing, packing, processing, preparing, safely used as a component of articles
treating, packaging, transporting, or intended for use in producing, manu-
holding food, subject to the provisions facturing, packing, processing, pre-
of this section. paring, treating, packaging, trans-
(a) The additive is applied to the sur- porting, or holding food, subject to the
face of calcium carbonate at a level not provisions of this section.
to exceed 1 weight-percent of the total (a) Industrial starch-modified is iden-
mixture. tified as follows:
(b) The calcium carbonate/glyceryl (1) A food starch-modified or starch
tri-(12-acetoxystearate) mixture is used or any combination thereof that has
as an adjuvant in polymers in contact been modified by treatment with one of
with nonfatty foods at a level not to the reactants hereinafter specified, in
exceed 20 weight-percent of the poly- an amount reasonably required to
mer. achieve the desired functional effect
but in no event in excess of any limita-
[50 FR 1503, Jan. 11, 1985] tion prescribed, with or without subse-
quent treatment as authorized in
List of reactants Limitations
Ammonium persulfate, not to exceed 0.3 pct. or in alkaline

starch not to exceed 0.6 pct..
(4-Chlorobutene-2) trimethylammonium chloride, not to exceed Industrial starch modified by this treatment shall be used only
5 pct. as internal sizing for paper and paperboard intended for food
packaging.
b-Diethylaminoethyl chloride hydrochloride, not to exceed 4 pct.
Dimethylaminoethyl methacrylate, not to exceed 3 pct.
Dimethylol ethylene urea, not to exceed 0.375 pct .................... Industrial starch modified by this treatment shall be used only
as internal sizing for paper and paperboard intended for food
packaging.
2,3-Epoxypropyltrimethylammonium chloride, not to exceed 5
pct.
Ethylene oxide, not to exceed 3 pct of reacted ethylene oxide
in finished product.
Phosphoric acid, not to exceed 6 pct and urea, not to exceed Industrial starch modified by this treatment shall be used only
20 pct. as internal sizing for paper and paperboard intended for food
packaging and as surface sizing and coating for paper and
paperboard that contact food only of Types IV-A, V, VII, VIII,
and IX described in table 1 of § 176.170(c) of this chapter.
(2) A starch irradiated under one of (ii) An electron beam source at a

the following conditions to produce maximum energy of 7 million electron
free radicals for subsequent graft po- volts of ionizing radiation, maximum
lymerization with the reactants listed absorbed dose not to exceed 5.0
in this paragraph (a)(2): megarads.
(i) Radiation from a sealed cobalt 60
source, maximum absorbed dose not to
exceed 5.0 megarads.
Acrylamide and [2-(methacryloyloxy) ethyl]trimethylammonium For use only as a retention aid and dry strength agent em-
methyl sulfate, such that the finished industrial starch-modi- ployed before the sheet-forming operation in the manufac-
fied shall contain: ture of paper and paperboard intended to contact food, and
used at a level not to exceed 0.25 pct by weight of the fin-
ished dry paper and paperboard fibers.
1. Not more than 60 weight percent vinyl copolymer (of
which not more than 32 weight percent is [2-
(methacryloyloxy)ethyl] trimethylammonium methyl sul-

fate).
415
§ 178.3530 21 CFR Ch. I (4–1–11 Edition)
2. Not more than 0.20 pct residual acrylamide.

3. A minimum nitrogen content of 9.0 pct.
(b) The following adjuvants may be Nonvolatile residue 0.002 gram per 100 milli-
used as surface-active agents in the liters maximum.
processing of industrial starch-modi- Synthetic isoparaffinic petroleum hydro-
fied: carbons containing antioxidants shall meet
the specified ultraviolet absorbance limits
Polyethylene glycol (400) dilaurate.
after correction for any absorbance due to
Polyethylene glycol (400) monolaurate.
the antioxidants. The ultraviolet absorb-
Polyoxyethylene (4) lauryl ether.
ance shall be determined by the procedure
(c) To insure safe use of the indus- described for application to mineral oil
trial starch-modified, the label of the under ‘‘Specifications’’ on page 66 of the
food additive container shall bear the ‘‘Journal of the Association of Official Ag-
name of the additive ‘‘industrial ricultural Chemists,’’ Vol. 45 (February
starch-modified,’’ and in the instance 1962), which is incorporated by reference,
of an industrial starch-modified which disregarding the last sentence of that pro-
cedure. For hydrocarbons boiling below 121
is limited with respect to conditions of
°C, the nonvolatile residue shall be deter-
use, the label of the food additive con-
mined by ASTM method D1353–78, ‘‘Stand-
tainer shall contain a statement of ard Test Method for Nonvolatile Matter in
such limited use. Volatile Solvents for Use in Paint, Var-
[42 FR 14609, Mar. 15, 1977, as amended at 42 nish, Lacquer, and Related Products;’’ for
FR 49453, Sept. 27, 1977] those boiling above 121 °C, ASTM proce-
dure D381–80, ‘‘Standard Test Method for
§ 178.3530 Isoparaffinic petroleum hy- Existent Gum in Fuels by Jet Evapo-
drocarbons, synthetic. ration,’’ which are incorporated by ref-
Isoparaffinic petroleum hydro- erence. Copies may be obtained from the
American Society for Testing Materials,
carbons, synthetic, may be safely used
100 Barr Harbor Dr., West Conshohocken,
in the production of nonfood articles Philadelphia, PA 19428-2959, or may be ex-
intended for use in producing, manu- amined at the National Archives and
facturing, packing, processing, pre- Records Administration (NARA). For in-
paring, treating, packaging, trans- formation on the availability of this mate-
porting, or holding food, subject to the rial at NARA, call 202–741–6030, or go to:
provisions of this section. http://www.archives.gov/federallregister/
(a) The isoparaffinic petroleum hy- codeloflfederallregulations/
drocarbons, produced by synthesis from ibrllocations.html.
petroleum gases consist of a mixture of
(b) Isoparaffinic petroleum hydro-
liquid hydrocarbons meeting the fol-
carbons may contain antioxidants au-
lowing specifications:
thorized for use in food in an amount
Boiling point 63° –260 °C, as determined by not to exceed that reasonably required
ASTM method D86–82, ‘‘Standard Method to accomplish the intended technical
for Distillation of Petroleum Products,’’
which is incorporated by reference. Copies effect.
may be obtained from the American Soci- (c) Isoparaffinic petroleum hydro-
ety for Testing Materials, 100 Barr Harbor carbons are used in the production of
Dr., West Conshohocken, Philadelphia, PA nonfood articles. The quantity used
19428-2959, or may be examined at the Na- shall not exceed the amount reason-
tional Archives and Records Administra-
tion (NARA). For information on the avail-
ably required to accomplish the in-
ability of this material at NARA, call 202– tended technical effect, and the resid-
741–6030, or go to: http://www.archives.gov/ ual remaining in the finished article
federallregister/ shall be the minimum amount reason-
codeloflfederallregulations/ ably attainable.
ibrllocations.html.
Ultraviolet absorbance: [42 FR 14609, Mar. 15, 1977, as amended at 47

260–319 millimicrons—1.5 maximum. FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19,
320–329 millimicrons—0.08 maximum. 1984]
330–350 millimicrons—0.05 maximum.
416
§ 178.3570 Lubricants with incidental (a) The lubricants are prepared from
food contact. one or more of the following sub-
stances:
Lubricants with incidental food con-
(1) Substances generally recognized
tact may be safely used on machinery
as safe for use in food.
used for producing, manufacturing, (2) Substances used in accordance
packing, processing, preparing, treat- with the provisions of a prior sanction
ing, packaging, transporting, or hold- or approval.
ing food, subject to the provisions of (3) Substances identified in this para-
this section: graph (a)(3).
Aluminum stearoyl benzoyl hydroxide ......................................... For use only as a thickening agent in mineral oil lubricants at a
level not to exceed 10 pct by weight of the mineral oil.
N,N-Bis(2-ethylhexyl)-ar-methyl-1H-benzotriazole-1- For use as a copper deactivator at a level not to exceed 0.1
methanamine (CAS Reg. No. 94270–86–7). percent by weight of the lubricant.
BHA.
BHT.
a-Butyl-omega-hydroxypoly(oxyethylene) poly(oxypropylene) Addition to food not to exceed 10 parts per million.
produced by random condensation of a 1:1 mixture by
weight of ethylene oxide and propylene oxide with butanol;
minimum molecular weight 1,500; Chemical Abstracts Serv-
ice Registry No. 9038–95–3.
a-Butyl-omega-hydroxypoly(oxypropylene); minimum molecular Do.
weight 1,500; Chemical Abstracts Service Registry No.
9003–13–8.
Castor oil ..................................................................................... Do.
Castor oil, dehydrated ................................................................. Do.
Castor oil, partially dehydrated .................................................... Do.
Dialkyldimethylammonium aluminum silicate (CAS Reg. No. For use only as a gelling agent in mineral oil lubricants at a
68953–58–2), which may contain up to 7 percent by weight level not to exceed 15 percent by weight of the mineral oil.
1,6-hexanediol (CAS Reg. No. 629–11–8), where the alkyl
groups are derived from hydrogenated tallow fatty acids
(C14-C18) and where the aluminum silicate is derived from
bentonite.
Dimethylpolysiloxane (viscosity greater than 300 centistokes) ... Addition to food not to exceed 1 part per million.
Di (n-octyl) phosphite (CAS Reg. No. 1809–14–9) ..................... For use only as an extreme pressure-antiwear adjuvant at a
level not to exceed 0.5 percent by weight of the lubricant.
Disodium decanedioate (CAS Reg. No. 17265–14–4) ............... For use only:
1. As a corrosion inhibitor or rust preventative in mineral oil-
bentonite lubricants at a level not to exceed 2 percent by
weight of the grease.
2. As a corrosion inhibitor or rust preventative only in greases
at a level not to exceed 2 percent by weight of the grease.
Disodium EDTA (CAS Reg. No. 139–33–3) ............................... For use only as a chelating agent and sequestrant at a level
not to exceed 0.06 percent by weight of lubricant at final use
dilution.
Ethoxylated resin phosphate ester mixture consisting of the fol- For use only as a surfactant to improve lubricity in lubricating
lowing compounds: fluids complying with this section at a level not to exceed 5
percent by weight of the lubricating fluid.
1. Poly(methylene-p-tert-butyl- phenoxy)poly-(oxyethylene)
mixture of dihydrogen phosphate and monohydrogen
phosphate esters (0 to 40 percent of the mixture). The
resin is formed by condensation of 1 mole of p-tert-
butylphenol with 2 to 4 moles of formaldehyde and sub-
sequent ethoxylation with 4 to 12 moles of ethylene
oxide;.
2. Poly(methylene-p-nonylphenoxy) poly(oxyethylene) mix-
ture of dihydrogen phosphate and monohydrogen phos-
phate esters (0 to 40 percent of the mixture). The resin
is formed by condensation of 1 mole of p-nonylphenol
with 2 to 4 moles of formaldehyde and subsequent
ethoxylation with 4 to 12 moles of ethylene oxide; and.
3. n-Tridecyl alcohol mixture of dihydrogen phosphate and
monohydrogen phosphate esters (40 to 80 percent of
the mixture; CAS Reg. No. 56831–62–0).
Fatty acids derived from animal or vegetable sources, and the
hydrogenated forms of such fatty acids.
2-(8-Heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol (CAS For use at levels not to exceed 0.5 percent by weight of the lu-
Reg. No. 95–38–5). bricant.
Hexamethylenebis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate) For use as an antioxidant at levels not to exceed 0.5 percent
(CAS Reg. No. 35074–77–2). by weight of the lubricant.
417
§ 178.3570 21 CFR Ch. I (4–1–11 Edition)
a-Hydro-omega-hydroxypoly (oxyethylene) poly(oxypropylene) Addition to food not to exceed 10 parts per million.
produced by random condensation of mixtures of ethylene
oxide and propylene oxide containing 25 to 75 percent by
weight of ethylene oxide; minimum molecular weight 1,500;
Chemical Abstracts Service Registry No. 9003–11–6.
12-Hydroxystearic acid.
Isopropyl oleate ........................................................................... For use only as an adjuvant (to improve lubricity) in mineral oil
lubricants.
Magnesium ricinoleate ................................................................. For use only as an adjuvant in mineral oil lubricants at a level
not to exceed 10 percent by weight of the mineral oil.
Mineral oil .................................................................................... Addition to food not to exceed 10 parts per million.
N-Methyl-N-(1-oxo-9- octadecenyl)glycine (CAS Reg. No. 110– For use as a corrosion inhibitor at levels not to exceed 0.5 per-
25–8). cent by weight of the lubricant.
N-phenylbenzenamine, reaction products with 2,4,4- For use only as an antioxidant at levels not to exceed 0.5 per-
trimethylpentene (CAS Reg. No. 68411–46–1). cent by weight of the lubricant.
Petrolatum ................................................................................... Complying with § 178.3700. Addition to food not to exceed 10
parts per million.
Phenyl-a-and/or phenyl-b-naphthylamine ................................... For use only, singly or in combination, as antioxidant in mineral
oil lubricants at a level not to exceed a total of 1 percent by
weight of the mineral oil.
Phosphoric acid, mono- and dihexyl esters, compounds with For use only as an adjuvant at levels not to exceed 0.5 per-
tetramethylnonylamines and C11-14 alkylamines. cent by weight of the lubricant.
Phosphoric acid, mono- and diisooctyl esters, reacted with tert- For use only as a corrosion inhibitor or rust preventative
alkyl and (C12-C14) primary amines (CAS Reg. No. 68187– inlubricants at a level not to exceed 0.5 percent by weight of
67–7). the lubricant.
Phosphorothioic acid, O, O, O-triphenyl ester, tert-butyl deriva- For use only as an extreme pressure-antiwear adjuvant at a
tives (CAS Reg. No. 192268–65–8). level not to exceed 0.5 percent by weight of the lubricant.
Polyurea, having a nitrogen content of 9–14 percent based on For use only as an adjuvant in mineral oil lubricants at a level
the dry polyurea weight, produced by reacting tolylene not to exceed 10 percent by weight of the mineral oil.
diisocyanate with tall oil fatty acid (C16 and C18) amine and
ethylene diamine in a 2:2:1 molar ratio.
Polybutene (minimum average molecular weight 80,000) .......... Addition to food not to exceed 10 parts per million.
Polybutene, hydrogenated; complying with the identity pre- Do.
scribed under § 178.3740.
Polyethylene ................................................................................ Do.
Polyisobutylene (average molecular weight 35,000–140,000 For use only as a thickening agent in mineral oil lubricants.
(Flory)).
Sodium nitrite ............................................................................... For use only as a rust preventive in mineral oil lubricants at a
level not to exceed 3 percent by weight of the mineral oil.
Tetrakis[methylene(3,5-di-tert-butyl-4-hydroxyhydro- For use only as an antioxidant in lubricants at a level not to ex-
cinnamate)]methane (CAS Reg. No. 6683–19–8). ceed 0.5 percent by weight of the lubricant.
Thiodiethylenebis (3,5-di-tert-butyl-4-hydroxyhydrocinnamate) For use as an antioxidant at levels not to exceed 0.5 percent
(CAS Reg. No. 41484-35-9). by weight of the lubricant.
Tri[2(or 4)-C9-10-branched alkylphenyl]phosphorothioate (CAS For use only as an extreme pressure-antiwear adjuvant at lev-
Reg. No. 126019–82–7). els not to exceed 0.5 percent by weight of the lubricant.
Triphenyl phosphorothionate (CAS Reg. No. 597–82–0) ........... For use as an adjuvant in lubricants herein listed at a level not
to exceed 0.5 percent by weight of the lubricant.
Tris(2,4-di-tert-butylphenyl)phosphite (CAS Reg. NO. 31570– For use only as a stabilizer at levels not to exceed 0.5 percent
04–4). by weight of the lubricant.
Thiodiethylenebis(3,5-di-tert-butyl-4-hydroxy-hydro- cinnamate) For use as an antioxidant at levels not to exceed 0.5 percent
(CAS Reg. No. 41484–35–9). by weight of the lubricant.
Zinc sulfide .................................................................................. For use at levels not to exceed 10 percent by weight of the lu-
bricant.
(b) The lubricants are used on food- (c) Any substance employed in the
processing equipment as a protective production of the lubricants described
antirust film, as a release agent on gas- in this section that is the subject of a
kets or seals of tank closures, and as a regulation in parts 174, 175, 176, 177, 178
lubricant for machine parts and equip- and § 179.45 of this chapter conforms
ment in locations in which there is ex- with any specification in such regula-
posure of the lubricated part to food. tion.
The amount used is the minimum re- [42 FR 14609, Mar. 15, 1977]
quired to accomplish the desired tech-
nical effect on the equipment, and the EDITORIAL NOTE: For FEDERAL REGISTER ci-
tations affecting § 178.3570, see the List of

addition to food of any constituent CFR Sections Affected, which appears in the
identified in this section does not ex- Finding Aids section of the printed volume
ceed the limitations prescribed. and at www.fdsys.gov.
418
§ 178.3600 Methyl glucoside-coconut oil this chapter may be used as a compo-

ester. nent of nonfood articles provided such
Methyl glucoside-coconut oil ester use complies with any applicable limi-
identified in § 172.816(a) of this chapter tations in parts 170 through 189 of this
may be safely used as a processing aid chapter. The use of white mineral oil in
(filter aid) in the manufacture of or on food itself, including the use of
starch, including industrial starch- white mineral oil as a protective coat-
modified complying with § 178.3520, in- ing or release agent for food, is subject
tended for use as a component of arti- to the provisions of § 172.878 of this
cles that contact food. chapter.
(b) Technical white mineral oil iden-
§ 178.3610 ù-Methylstyrene- tified in paragraph (b)(1) of this section
vinyltoluene resins, hydrogenated. may be used as provided in paragraph
Hydrogenated a-methylstyrene- (b)(2) of this section.
vinyltoluene copolymer resins having a (1) Technical white mineral oil con-
molar ratio of 1 a-methylstyrene to 3 sists of specially refined distillates of
vinyltoluene may be safely used as virgin petroleum or of specially refined
components of polyolefin film intended distillates that are produced syn-
for use in contact with food, subject to thetically from petroleum gases. Tech-
the following provisions: nical white mineral oil meets the fol-
(a) Hydrogenated a-methylstyrene- lowing specifications:
vinyltoluene copolymer resins have a (i) Saybolt color 20 minimum as de-
drop-softening point of 125° to 165 °C termined by ASTM method D156–82,
and a maximum absorptivity of 0.17 ‘‘Standard Test Method for Saybolt
liter per gram centimeter at 266 nano- Color of Petroleum Products (Saybolt
meters, as determined by methods ti- Chromometer Method),’’ which is in-
tled ‘‘Determination of Softening Point corporated by reference. Copies may be
(Drop Method)’’ and ‘‘Determination of obtained from the American Society
Unsaturation of Resin 1977,’’ which are for Testing Materials, 100 Barr Harbor
incorporated by reference. Copies are Dr., West Conshohocken, Philadelphia,
available from the Center for Food PA 19428-2959, or may be examined at
Safety and Applied Nutrition (HFS– the National Archives and Records Ad-
200), Food and Drug Administration, ministration (NARA). For information
5100 Paint Branch Pkwy., College Park, on the availability of this material at
MD 20740, or available for inspection at NARA, call 202–741–6030, or go to: http://
the National Archives and Records Ad- www.archives.gov/federallregister/
ministration (NARA). For information codeloflfederallregulations/
on the availability of this material at ibrllocations.html.
NARA, call 202–741–6030, or go to: http:// (ii) Ultraviolet absorbance limits as
www.archives.gov/federallregister/ follows:
codeloflfederallregulations/
ibrllocations.html. Maximum
absorb-
(b) The polyolefin film is produced ance per
Wavelength (mμ)
from olefin polymers complying with centimeter
optical
§ 177.1520 of this chapter, and the aver- pathlength
age thickness of the film in the form in
which it contacts food does not exceed 280 to 289 ........................................................... 4.0
290 to 299 ........................................................... 3.3
0.002 inch. 300 to 329 ........................................................... 2.3
330 to 350 ........................................................... 0.8
[42 FR 14609, Mar. 15, 1977, as amended at 47
FR 11847, Mar. 19, 1982; 54 FR 24898, June 12,
1989] Technical white mineral oil containing
antioxidants shall meet the specified
§ 178.3620 Mineral oil. ultraviolet absorbance limits after cor-
Mineral oil may be safely used as a rection for any absorbance due to the
component of nonfood articles intended antioxidants. The ultraviolet absorb-
for use in contact with food, subject to ance shall be determined by the proce-
the provisions of this section: dure described for application to min-

(a) White mineral oil meeting the eral oil under ‘‘Specification’’ on page
specifications prescribed in § 172.878 of 66 of the ‘‘Journal of the Association of
419
§ 178.3620 21 CFR Ch. I (4–1–11 Edition)
Official Agricultural Chemists,’’ Vol- reference is given in paragraph (b)(1)(i)

ume 45 (February 1962) (which is incor- of this section.
porated by reference; copies are avail- (iii) Ultraviolet absorbance limits as
able from the Center for Food Safety follows as determined by the analytical
and Applied Nutrition (HFS–200), Food method described in paragraph (c)(3) of
and Drug Administration, 5100 Paint this section:
Branch Pkwy., College Park, MD 20740,
or available for inspection at the Na- Maximum
absorb-
tional Archives and Records Adminis- Wavelength (mμ) ance per
tration (NARA). For information on centimeter
optical
the availability of this material at pathlength
NARA, call 202–741–6030, or go to: http://
280 to 289 ........................................................... 0.7
www.archives.gov/federallregister/ 290 to 299 ........................................................... 0.6
codeloflfederallregulations/ 300 to 359 ........................................................... 0.4
ibrllocations.html.), disregarding the 360 to 400 ........................................................... .09
last two sentences of that procedure
and substituting therefor the fol- (2) The mineral oil may be used wher-
lowing: Determine the absorbance of ever mineral oil is permitted for use as
the mineral oil extract in a 10-milli- a component of nonfood articles com-
meter cell in the range from 260–350 plying with §§ 175.105 and 176.210 of this
mμ, inclusive, compared to the solvent chapter and § 178.3910 (for use only in
control. If the absorbance so measured rolling of metallic foil and sheet
exceeds 2.0 at any point in range 280–350 stock), §§ 176.200, 177.2260, 177.2600, and
mμ, inclusive, dilute the extract and 177.2800 of this chapter.
the solvent control, respectively, to (3) The analytical method for deter-
twice their volume with dimethyl sulf- mining ultraviolet absorbance limit is
oxide and remeasure the absorbance. as follows:
Multiply the remeasured absorbance
values by 2 to determine the absorb- GENERAL INSTRUCTIONS
ance of the mineral oil extract per cen- Because of the sensitivity of the test, the
timeter optical pathlength. possibility of errors arising from contamina-
(2) Technical white mineral oil may tion is great. It is of the greatest importance
be used wherever mineral oil is per- that all glassware be scrupulously cleaned to
mitted for use as a component of remove all organic matter such as oil,
grease, detergent residues, etc. Examine all
nonfood articles complying with
glassware, including stoppers and stopcocks,
§§ 175.105, 176.200, 176.210, 177.2260, under ultraviolet light to detect any residual
177.2600, and 177.2800 of this chapter and fluorescent contamination. As a pre-
§§ 178.3570 and 178.3910. cautionary measure it is recommended prac-
(3) Technical white mineral oil may tice to rinse all glassware with purified iso-
contain any antioxidant permitted in octane immediately before use. No grease is
food by regulations issued in accord- to be used on stopcocks or joints. Great care
ance with section 409 of the Act, in an to avoid contamination of oil samples in
handling and to assure absence of any extra-
amount not greater than that required
neous material arising from inadequate
to produce its intended effect. packaging is essential. Because some of the
(c) Mineral oil identified in para- polynuclear hydrocarbons sought in this test
graph (c)(1) of this section may be used are very susceptible to photo-oxidation, the
as provided in paragraph (c)(2) of this entire procedure is to be carried out under
section. subdued light.
(1) The mineral oil consists of virgin
APPARATUS
petroleum distillates refined to meet
the following specifications: Separatory funnels. 250-milliliter, 500-milli-
(i) Initial boiling point of 450 °F min- liter, 1,000-milliliter, and preferably 2,000-
imum. milliliter capacity, equipped with tetra-
fluoroethylene polymer stopcocks.
(ii) Color 5.5 maximum as determined
Reservoir. 500-milliliter capacity, equipped
by ASTM method D1500–82, ‘‘Standard with a 24/40 standard taper male fitting at
Test Method for ASTM Color of Petro-
the bottom and a suitable ball-joint at the

leum Products (ASTM Color Scale),’’ top for connecting to the nitrogen supply.
which is incorporated by reference. The The male fitting should be equipped with
availability of this incorporation by glass hooks.
420
Chromatographic tube. 180 millimeters in REAGENTS AND MATERIALS
length, inside diameter to be 15.7 millimeters
±0.1 millimeter, equipped with a coarse, frit- Organic solvents. All solvents used through-
ted-glass disc, a tetrafluoroethylene polymer out the procedure shall meet the specifica-
stopcock, and a female 24/40 standard tapered tions and tests described in this specifica-
fitting at the opposite end. (Overall length of tion. The isooctane, benzene, acetone, and
the column with the female joint is 235 milli- methyl alcohol designated in the list fol-
meters.) The female fitting should be lowing this paragraph shall pass the fol-
equipped with glass hooks. lowing test:
Disc. Tetrafluoroethylene polymer 2-inch To the specified quantity of solvent in a
diameter disk approximately 3⁄16-inch thick 250-milliliter Erlenmeyer flask, add 1 milli-
with a hole bored in the center to closely fit liter of purified n-hexadecane and evaporate
the stem of the chromatographic tube. on the steam bath under a stream of nitro-
Suction flask. 250-milliliter or 500-milliliter gen (a loose aluminum foil jacket around the
filter flask. flask will speed evaporation). Discontinue
Condenser. 24/40 joints, fitted with a drying evaporation when not over 1 milliliter of res-
tube, length optional. idue remains. (To the residue from benzene
Evaporation flask (optional). 250-milliliter or add a 10-milliliter portion of purified iso-
500-milliliter capacity all-glass flask octane, reevaporate, and repeat once to in-
equipped with standard taper stopper having sure complete removal of benzene.)
inlet and outlet tubes to permit passage of Alternatively, the evaporation time can be
nitrogen across the surface of contained liq- reduced by using the optional evaporation
uid to be evaporated. flask. In this case the solvent and n-hexa-
Spectrophotometric cells. Fused quartz cells, decane are placed in the flask on the steam
optical path length in the range of 5,000 cen- bath, the tube assembly is inserted, and a
timeter ±0.005 centimeter; also for checking stream of nitrogen is fed through the inlet
spectrophotometer performance only, optical tube while the outlet tube is connected to a
path length in the range 1,000 centimeter solvent trap and vacuum line in such a way
±0.005 centimeter. With distilled water in the as to prevent any flow-back of condensate
cells, determine any absorbance differences. into the flask.
Spectrophotometer. Spectral range 250 milli- Dissolve the 1 milliliter of hexadecane res-
microns—400 millimicrons with spectral slit idue in isooctane and make to 25 milliliters
width of 2 millimicrons or less; under instru- volume. Determine the absorbance in the 5-
ment operating conditions for these absorb- centimeter path length cells compared to
ance measurements, the spectrophotometer isooctane as reference. The absorbance of the
shall also meet the following performance solution of the solvent residue (except for
requirements: methyl alcohol) shall not exceed 0.01 per cen-
Absorbance repeatability, ±0.01 at 0.4 ab- timeter path length between 280 and 400 mμ.
sorbance. For methyl alcohol this absorbance value
Absorbance accuracy 1 ±0.05 at 0.4 absorb- shall be 0.00.
ance. Isooctane (2,2,4-trimethylpentane). Use 180
Wavelength accuracy, ±1.0 millimicron. milliliters for the test described in the pre-
Nitrogen cylinder. Water-pumped or equiva- ceding paragraph. Purify, if necessary, by
lent purity nitrogen in cylinder equipped passage through a column of activated silica
with regulator and valve to control flow at 5 gel (Grade 12, Davison Chemical Company,
p.s.i.g. Baltimore, Maryland, or equivalent) about 90
centimeters in length and 5 centimeters to 8
1 As determined by procedure using potas- centimeters in diameter.
sium chromate for reference standard and Benzene, A.C.S. reagent grade. Use 150 milli-
described in National Bureau of Standards liters for the test. Purify, if necessary, by
Circular 484, Spectrophotometry, U.S. De- distillation or otherwise.
partment of Commerce (1949). The accuracy Acetone, A.C.S. reagent grade. Use 200 milli-
is to be determined by comparison with the liters for the test. Purify, if necessary, by
standard values at 290, 345, and 400 milli- distillation.
microns. Circular 484 is incorporated by ref- Eluting mixtures:
erence. Copies are available from the Center 1. 10 percent benzene in isooctane. Pipet 50
for Food Safety and Applied Nutrition (HFS– milliliters of benzene into a 250-milliliter
200), Food and Drug Administration, 5100 glass-stoppered volumetric flask and adjust
Paint Branch Pkwy., College Park, MD 20740, to volume with isooctane, with mixing.
or available for inspection at the National 2. 20 percent benzene in isooctane. Pipet 50
Archives and Records Administration milliliters of benzene into a 250-milliliter
(NARA). For information on the availability glass-stoppered volumetric flask and adjust
of this material at NARA, call 202–741–6030, to volume with isooctane, with mixing.
or go to: http://www.archives.gov/ 3. Acetone-benzene-water mixture. Add 20
federallregister/codeloflfederallregulations/ milliliters of water to 380 milliliters of ace-
ibrllocations.html. tone and 200 milliliters of benzene, and mix.
421
§ 178.3620 21 CFR Ch. I (4–1–11 Edition)
n-Hexadecane, 99-percent olefin-free. Dilute meter to 2 centimeters thick. Reheat the
1.0 milliliter of n-hexadecane to 25 milliliters mixture at 160 °C ±1 °C for 2 hours, and store
with isooctane and determine the absorbance in a tightly closed flask.
in a 5-centimeter cell compared to isooctane Sodium sulfate, anhydrous, A.C.S. reagent
as reference point between 280 mμ–400 mμ. grade, preferably in granular form. For each
The absorbance per centimeter path length bottle of sodium sulfate reagent used, estab-
shall not exceed 0.00 in this range. Purify, if lish as follows the necessary sodium sulfate
necessary, by percolation through activated prewash to provide such filters required in
silica gel or by distillation. the method: Place approximately 35 grams of
Methyl alcohol, A.C.S. reagent grade. Use anhydrous sodium sulfate in a 30-milliliter
10.0 milliliters of methyl alcohol. Purify, if course, fritted-glass funnel or in a 65-milli-
necessary, by distillation. meter filter funnel with glass wool plug;
Dimethyl sulfoxide. Spectrophotometric wash with successive 15-milliliter portions of
grade (Crown Zellerbach Corporation, the indicated solvent until a 15-milliliter
Camas, Washington, or equivalent). Absorb- portion of the wash shows 0.00 absorbance
ance (1-centimeter cell, distilled water ref- per centimeter path length between 280 mμ
erence, sample completely saturated with ni- and 400 mμ when tested as prescribed under
trogen). ‘‘Organic solvents.’’ Usually three portions
of wash solvent are sufficient.
Absorb- Before proceeding with analysis of a sam-
Wavelength ance (max- ple, determine the absorbance in a 5-centi-
imum)
meter path cell between 250 millimicrons and
261.5 .................................................................... 1.00 400 millimicrons for the reagent blank by
270 ....................................................................... .20 carrying out the procedure, without an oil
275 ....................................................................... .09 sample, recording the spectra after the ex-
280 ....................................................................... .06 traction stage and after the complete proce-
300 ....................................................................... .015 dure as prescribed. The absorbance per centi-
meter pathlength following the extraction
There shall be no irregularities in the ab- stage should not exceed 0.02 in the wave-
sorbance curve within these wavelengths. length range from 280 mμ to 400 mμ; the ab-
Phosphoric acid. 85 percent A.C.S. reagent sorbance per centimeter pathlength fol-
grade. lowing the complete procedure should not
Sodium borohydride. 98 percent. exceed 0.02 in the wavelength range from 280
Magnesium oxide (Sea Sorb 43, Food Machin- mμ to 400 mμ. If in either spectrum the char-
ery Company, Westvaco Division, distributed by acteristic benzene peaks in the 250 mμ–260
chemical supply firms, or equivalent). Place 100 mμ region are present, remove the benzene
grams of the magnesium oxide in a large by the procedure under ‘‘Organic solvents’’
beaker, add 700 milliliters of distilled water and record absorbance again.
to make a thin slurry, and heat on a steam Place 300 milliliters of dimethyl sulfoxide
bath for 30 minutes with intermittent stir- in a 1-liter separatory funnel and add 75 mil-
ring. Stir well initially to insure that all the liliters of phosphoric acid. Mix the contents
adsorbent is completely wetted. Using a of the funnel and allow to stand for 10 min-
Buchner funnel and a filter paper (Schleicher utes. (The reaction between the sulfoxide
& Schuell No. 597, or equivalent) of suitable and the acid is exothermic. Release pressure
diameter, filter with suction. Continue suc- after mixing, then keep funnel stoppered.)
tion until water no longer drips from the Add 150 milliliters of isooctane and shake to
funnel. Transfer the adsorbent to a glass pre-equilibrate the solvents. Draw off the in-
trough lined with aluminum foil (free from dividual layers and store in glass-stoppered
rolling oil). Break up the magnesia with a flasks.
clean spatula and spread out the adsorbent Weigh a 20-gram sample of the oil and
on the aluminum foil in a layer about 1 cen- transfer to a 500-milliliter separatory funnel
timeter to 2 centimeters thick. Dry for 24 containing 100 milliliters of pre-equilibrated
hours at 160 °C ±1 °C. Pulverize the magnesia sulfoxide-phosphoric acid mixture. Complete
with mortar and pestle. Sieve the pulverized the transfer of the sample with small por-
adsorbent between 60–180 mesh. Use the mag- tions of preequilibrated isooctane to give a
nesia retained on the 180-mesh sieve. total volume of the oil and solvent of 75 mil-
Celite 545. Johns Mansville Company, diato- liliters. Shake the funnel vigorously for 2
maceous earth, or equivalent. minutes. Set up three 250-milliliter sepa-
Magnesium oxide-Celite 545 mixture (2+1) by ratory funnels with each containing 30 milli-
weight. Place the magnesium oxide (60–180 liters of pre-equilibrated isooctane. After
mesh) and the Celite 545 in 2 to 1 propor- separation of liquid phases, carefully draw
tions, respectively, by weight in a glass- off lower layer into the first 250-milliliter
stoppered flask large enough for adequate separatory funnel and wash in tandem with
mixing. Shake vigorously for 10 minutes. the 30-milliliter portions of isooctane con-
Transfer the mixture to a glass trough lined tained in the 250-milliliter separatory fun-
with aluminum foil (free from rolling oil) nels. Shaking time for each wash is 1
and spread it out on a layer about 1 centi- minute. Repeat the extraction operation
422
with two additional portions of the sulf- denser equipped with a 24/40 joint and with a
oxide-acid mixture and wash each extractive drying tube into the flask, mix until the
in tandem through the same three portions borohydride is dissolved, and allow to stand
of isooctane. for 30 minutes at room temperature, with
Collect the successive extractives (300 mil- intermittent swirling. At the end of this pe-
liliters total) in a separatory funnel (pref- riod, disconnect the flask and evaporate the
erably 2-liter) containing 480 milliliters of methyl alcohol on the steam bath under ni-
distilled water; mix, and allow to cool for a trogen until the sodium borohydride begins
few minutes after the last extractive has to come out of the solution. Then add 10 mil-
been added. Add 80 milliliters of isooctane to
liliters of isooctane and evaporate to a vol-
the solution and extract by shaking the fun-
ume of about 2–3 milliliters. Again, add 10
nel vigorously for 2 minutes. Draw off the
lower aqueous layer into a second separatory milliliters of isooctane and concentrate to a
funnel (preferably 2-liter) and repeat the ex- volume of approximately 5 milliliters. Swirl
traction with 80 milliliters of isooctane. the flask repeatedly to assure adequate
Draw off and discard the aqueous layer. washing of the sodium borohydride residues.
Wash each of the 80-milliliter extractives Fit the tetrafluoroethylene polymer disc
three times with 100-milliliter portions of on the upper part of the stem of the
distilled water. Shaking time for each wash chromatographic tube, then place the tube
is 1 minute. Discard the aqueous layers. Fil- with the disc on the suction flask and apply
ter the first extractive through anhydrous the vacuum (approximately 135 millimeters
sodium sulfate prewashed with isooctane (see Hg pressure). Weigh out 14 grams of the 2:1
Sodium sulfate under ‘‘Reagents and Mate- magnesium oxide-Celite 545 mixture and
rials’’ for preparation of filter) into a 250- pour the adsorbent mixture into the
milliliter Erlenmeyer flask (or optionally chromatographic tube in approximately 3-
into the evaporation flask). Wash the first centimeter layers. After the addition of each
separatory funnel with the second 80-milli- layer, level off the top of the adsorbent with
liter isooctane extractive and pass through a flat glass rod or metal plunger by pressing
the sodium sulfate. Then wash the second
down firmly until the adsorbent is well
and first separatory funnels successively
packed. Loosen the topmost few millimeters
with a 20-milliliter portion of isooctane and
of each adsorbent layer with the end of a
pass the solvent through the sodium sulfate
into the flask. Add 1 milliliter of n-hexa- metal rod before the addition of the next
decane and evaporate the isooctane on the layer. Continue packing in this manner until
steam bath under nitrogen. Discontinue all the 14 grams of the adsorbent is added to
evaporation when not over 1 milliliter of res- the tube. Level off the top of the adsorbent
idue remains. To the residue, add a 10-milli- by pressing down firmly with a flat glass rod
liter portion of isooctane, reevaporate to 1 or metal plunger to make the depth of the
milliliter of hexadecane, and repeat this op- adsorbent bed approximately 12.5 centi-
eration once. meters in depth. Turn off the vacuum and re-
Quantitatively transfer the residue with move the suction flask. Fit the 500–milliliter
isooctane to a 200-milliliter volumetric reservoir onto the top of the
flask, make to volume, and mix. Determine chromatographic column and prewet the col-
the absorbance of the solution in the 1-centi- umn by passing 100 milliliters of isooctane
meter pathlength cells compared to iso- through the column. Adjust the nitrogen
octane as reference between 280 mμ–400 mμ pressure so that the rate of descent of the
(take care to lose none of the solution in fill- isooctane coming off the column is between
ing the sample cell). Correct the absorbance 2–3 milliliters per minute. Discontinue pres-
values for any absorbance derived from re- sure just before the last of the isooctane
agents as determined by carrying out the
reaches the level of the adsorbent. (Caution:
procedure without an oil sample. If the cor-
Do not allow the liquid level to recede below
rected absorbance does not exceed the limits
the adsorbent level at any time.) Remove the
prescribed in this paragraph, the oil meets
reservoir and decant the 5–milliliter iso-
the ultraviolet absorbance specifications. If
the corrected absorbance per centimeter octane concentrate solution onto the column
pathlength exceeds the limits prescribed in and with slight pressure again allow the liq-
this paragraph, proceed as follows: Quan- uid level to recede to barely above the ad-
titatively transfer the isooctane solution to sorbent level. Rapidly complete the transfer
a 125-milliliter flask equipped with 24/40 similarly with two 5–milliliter portions of
joint, and evaporate the isooctane on the isooctane, swirling the flask repeatedly each
steam bath under a stream of nitrogen to a time to assure adequate washing of the res-
volume of 1 milliliter of hexadecane. Add 10 idue. Just before the final 5–milliliter wash
milliliters of methyl alcohol and approxi- reaches the top of the adsorbent, add 100 mil-
mately 0.3 gram of sodium borohydride. liliters of isooctane to the reservoir and con-
(Minimize exposure of the borohydride to the tinue the percolation at the 2–3 milliliters
atmosphere. A measuring dipper may be per minute rate. Just before the last of the
used.) Immediately fit a water-cooled con- isooctane reaches the adsorbent level, add
423
§ 178.3620 21 CFR Ch. I (4–1–11 Edition)
100 milliliters of 10 percent benzene in iso- 2 percent, as determined by ASTM
octane to the reservoir and continue the per- method D86–82, ‘‘Standard Method for
colation at the aforementioned rate. Just be-
fore the solvent mixture reaches adsorbent
Distillation of Petroleum Products,’’
level, add 25 milliliters of 20 percent benzene which is incorporated by reference. The
in isooctane to the reservoir and continue availability of this incorporation by
the percolation at 2–3 milliliters per minute reference is given in paragraph (b)(1)(i)
until all this solvent mixture has been re- of this section.
moved from the column. Discard all the
elution solvents collected up to this point.
(ii) Ultraviolet absorbance limits as
Add 300 milliliters of the acetone-benzene- follows as determined by the method
water mixture to the reservoir and percolate described in paragraph (d)(3) of this
through the column to eluate the section.
polynuclear compounds. Collect the eluate in
a clean 1-liter separatory funnel. Allow the Maximum
column to drain until most of the solvent absorb-
ance per
mixture is removed. Wash the eluate three Wavelength (mμ) centimeter
times with 300-milliliter portions of distilled optical
water, shaking well for each wash. (The addi- pathlength
tion of small amounts of sodium chloride fa-
280 to 299 ........................................................... 2.3
cilitates separation.) Discard the aqueous
300 to 319 ........................................................... 1.2
layer after each wash. After the final separa-
320 to 359 ........................................................... .8
tion, filter the residual benzene through an-
360 to 400 ........................................................... .3
hydrous sodium sulfate pre-washed with ben-
zene (see Sodium sulfate under ‘‘Reagents
and Materials’’ for preparation of filter) into (iii) Pyrene content not to exceed a
a 250-milliliter Erlenmeyer flask (or option- maximum of 25 parts per million as de-
ally into the evaporation flask). Wash the termined by the method described in
separatory funnel with two additional 20- paragraph (d)(3) of this section.
milliliter portions of benzene which are also
filtered through the sodium sulfate. Add 1
(2) The mineral oil may be used only
milliliter of n-hexadecane and completely re- in the processing of jute fiber employed
move the benzene by evaporation under ni- in the production of textile bags in-
trogen, using the special procedure to elimi- tended for use in contact with the fol-
nate benzene as previously described under lowing types of food: Dry grains and
‘‘Organic solvents.’’ Quantitatively transfer dry seeds (for example, beans, peas,
the residue with isooctane to a 200-milliliter
volumetric flask and adjust to volume. De- rice, and lentils); whole root crop vege-
termine the absorbance of the solution in the tables of the types identified in 40 CFR
1-centimeter pathlength cells compared to 180.34(f); unshelled and shelled nuts (in-
isooctane as reference between 250 mμ–400 cluding peanuts); and dry animal feed.
mμ. Correct for any absorbance derived from The finished processed jute fiber shall
the reagents as determined by carrying out contain no more than 6 percent by
the procedure without an oil sample. If ei-
ther spectrum shows the characteristic ben- weight of residual mineral oil.
zene peaks in the 250 mμ–260 mμ region, evap- (3) The analytical method for deter-
orate the solution to remove benzene by the mining ultraviolet absorbance limits
procedure under ‘‘Organic solvents.’’ Dis- and pyrene content is as follows:
solve the residue, transfer quantitatively,
and adjust to volume in isooctane in a 200- I. Apparatus. A. Assorted beakers, sepa-
milliliter volumetric flask. Record the ab- ratory funnels fitted with tetrafluoro-
sorbance again. If the corrected absorbance ethylene polymer stopcocks, and graduated
does not exceed the limits proposed in this cylinders.
paragraph, the oil meets the proposed ultra- B. Volumetric flasks, 200-milliliter.
violet absorbance specifications. C. A chromatographic column made from
(d) Mineral oil identified in para- nominal 1.3 centimeters outside diameter ×
75 centimeters glass tubing tapered at one
graph (d)(1) of this section may be used
end and joined to a 2-millimeter-bore tetra-
as provided in paragraph (d)(2) of this fluoroethylene polymer stopcock. The oppo-
section. site end is flanged and joined to a female 24/
(1) The mineral oil consists of virgin 40 standard taper fitting. This provides for
petroleum distillates refined to meet accommodating the 500-milliliter reservoir
the following specifications: described in item I.E below.
(i) Distillation endpoint at 760 milli- D. A chromatographic column made from

meters pressure not to exceed 371 °C, nominal 1.7 centimeters outside diameter ×
with a maximum residue not to exceed 115 centimeters glass tubing tapered at one
424
end and joined to a 2-millimeter-bore tetra- n-hexadecane residue in isooctane and make
fluoroethylene polymer stopcock. The oppo- to 10-milliliter volume. Determine the ab-
site end is flanged and joined to a 2.5 centi- sorbance in 1.0-centimeter pathlength cells
meters outside diameter × 9.0 centimeters compared to water as reference. The absorb-
glass tube having a female 24/40 standard ance of the solution of solvent residue shall
taper fitting. This provides for accommo- not exceed 0.05 between 280 and 400 mμ.
dating the 500-milliliter reservoir described 1. Isooctane (2,2,4-trimethylpentane). Use 240
in item I. E below. milliliters for the above test. Purify, if nec-
E. A 500-milliliter reservoir having a 24/40 essary, by passage through a column of acti-
standard taper male fitting at bottom and a vated silica gel.
suitable ball joint at the top for connecting 2. Benzene. Use 200 milliliters for the above
to the nitrogen supply. The female fitting of test. Purify, if necessary, by distillation or
the chromatographic columns described in otherwise.
items I. C and D above and the male fitting 3. Cyclohexane. Use 70 milliliters for the
of the reservoir described in this item E above test. Purify, if necessary, by distilla-
should both be equipped with glass hooks. tion, silica gel percolation, or otherwise.
(NOTE: Rubber stoppers are not to be used. 4. Nitromethane. Use 125 milliliters for the
Stopcock grease is not to be used on ground- above test. Purify, if necessary, by distilla-
glass joints in this method.) tion or otherwise.
5. n-Hexadecane. Determine the absorbance
F. A spectrophotometer equipped to auto-
on this solvent directly. Purify, if necessary,
matically record absorbance of liquid sam-
by silica gel percolation or otherwise.
ples in 1-centimeter pathlength cells in the
B. Other materials—1. Pyrene standard ref-
spectral region of 280–400 mμ with a spectral
erence. Pyrene, reagent grade, melting point
slit width of 2 mμ or less. At an absorbance
level of about 0.4, absorbance measurements range 150–152 °C. (Organic Chemical 3627,
shall be repeatable within ±0.01 and accurate Eastman Kodak Co., Rochester, N.Y., or
within ±0.05. Wavelength measurements shall equivalent). The standard reference absorb-
be repeatable with ±0.2 mμ and accurate ance is the absorbance at 334 millimicrons of
within ±1.0 mμ. Instrument operating condi- a standard reference solution of pyrene con-
tions are selected to realize this performance taining a concentration of 1.0 milligram per
under dynamic (automatic) recording oper- liter in purified isooctane measured against
ations. Accuracy of absorbance measure- isooctane of the same spectral purity in 1.0-
ments are determined at 290, 345, and 400 mμ, centimeter cells. (This absorbance will be ap-
using potassium chromate as the reference proximately 0.28.)
standard. (National Bureau of Standards Cir- 2. Chrysene solution. Prepare a solution at a
cular 484, Spectrophotometry, U.S. Depart- concentration of 5.0 milligrams per liter by
ment of Commerce, 1949.) dissolving 5.0 milligrams of chrysene in puri-
G. Two fused quartz cells having fied isooctane in a 1-liter volumetric flask.
pathlengths of 1.00±0.005 centimeter or bet- Adjust to volume with isooctane.
ter. 3. Nitrogen gas. Water pumped or equivalent
II. Purity of reagents and materials. Reagent- purity, cylinder with regulator, and valve
grade chemicals shall be used in all tests. It control flow at 5 p.s.i.
is further specified that each chemical shall 4. Silica gel. 100–200 mesh (Davison Chem-
be tested for purity in accordance with the ical, Baltimore, Md., Grade 923, or equiva-
instruction given under ‘‘Reagents and Mate- lent), purified and activated by the following
rials’’ in III below. In addition, a blank run procedure: Place about 1 kilogram of silica
by the procedure shall be made on each puri- gel in a large column and wash with con-
fied lot of reagents and materials. Unless taminant-free benzene until a 200-milliliter
otherwise indicated, references to water sample of the benzene coming off the column
shall be understood to mean distilled water. will pass the ultraviolet absorption test for
III. Reagents and materials— A. Organic sol- benzene. This test is performed as stipulated
vents. All solvents used throughout the pro- under ‘‘Organic solvents’’ in A under III
cedure shall meet the specifications and above. When the silica gel has been suffi-
tests described in this section III. The iso- ciently cleaned, activate the gel before use
octane, benzene, cyclohexane, nitromethane, by placing the 1-kilogram batch in a shallow
and n-hexadecane designated shall pass the container in a layer no greater than 1 inch in
following test: To the specified quantity of depth and heating in an oven (Caution! Ex-
solvent in a 150-milliliter beaker, add 1 milli- plosion Hazard) at 130 °C. for 16 hours, and
liter of purified n-hexadecane and evaporate store in a vacuum desiccator. Reheating
on the steam bath under a stream of nitro- about once a week is necessary if the silica
gen. Discontinue evaporation when not over gel is repeatedly removed from the desic-
1 milliliter of residue remains (to the residue cator.
from benzene and nitromethane add a 10-mil- 5. Aluminum oxide (Aluminum Co. of America,
liliter portion of purified isooctane, re-evap- Grade F-20, or equivalent grade). 80–200 mesh,
orate, and repeat once to insure complete re- purified and activated by the following pro-
moval of solvent). Dissolve the 1 milliliter of cedure: Place about 1 kilogram of aluminum
425
§ 178.3620 21 CFR Ch. I (4–1–11 Edition)
oxide in a large column and wash with con- tion until a 100-milliliter eluate has been ob-
taminant-free benzene until a 200-milliliter tained.
sample of the benzene coming off the column h. Measure the amount of chrysene in this
will pass the ultraviolet absorption test for 100-milliliter fraction by ultraviolet anal-
benzene. This test is performed as stipulated ysis. If the aluminum oxide is satisfactory,
under ‘‘Organic solvents’’ in A under III more than 80 percent of the original amount
above. (Caution! Remove Benzene From Ad- of chrysene should be found in this fraction.
sorbent Under Vacuum To Minimize Explo- (NOTE: If the amount of chrysene recovered
sion Hazard in Subsequent Heating!) When is less than 80 percent, the original batch of
the aluminum oxide has been sufficiently aluminum oxide should be sieved between
cleaned and freed of solvent, activate it be- 100–160 mesh. Activation and testing of this
fore use by placing the 1-kilogram batch in a sieved batch should indicate a satisfactory
shallow container in a layer no greater than aluminum oxide for use.)
1 inch in depth. Heat in an oven at 130 °C for IV. Sampling. Precautions must be taken to
16 hours. Upon removal from heat, store at insure that an uncontaminated sample of the
atmospheric pressure over 80 percent (by mineral oil is obtained since ultraviolet ab-
weight) sulfuric acid in a desiccator for at sorption is very sensitive to small amounts
least 36 hours before use. This gives alu- of extraneous material contaminating the
minum oxide with between 6 to 9.5 percent sample through careless handling.
volatiles. This is determined by heating a V. Procedure. A. Blank. Before proceeding
weighed sample of the prepared aluminum with the analysis of a sample, determine the
oxide at 2,000 °F for 2 hours and then quickly absorbance of the solvent residues by car-
reweighing. To insure the proper adsorptive rying out the procedure without a sample.
properties of the aluminum oxide, perform B. Sample. 1. Weigh out 20.0 grams ±0.1
the following test: gram of the mineral oil into a beaker and
a. Weigh 50 grams ±1 gram of the activated transfer to a 250-milliliter separatory funnel
aluminum oxide and pack into the fitted with a tetrafluoroethylene polymer
chromatographic column (1.3 centimeters × stopcock, using enough cyclohexane (25 mil-
75 centimeters) described under ‘‘Apparatus’’ liliters) to give a final total volume of 50
in C under I above. Use glass wool at the col- milliliters (mineral oil plus cyclohexane).
umn exit to prevent the aluminum oxide 2. Add 25 milliliters of nitromethane satu-
from passing through the column. rated with cyclohexane and shake by hand
b. Place a 250-milliliter graduated cylinder vigorously for 3 minutes. Recover the lower
under the column to measure the amount of nitromethane layer in a 150-milliliter beaker
eluate coming from the column. containing 1 milliliter of n-hexadecane and
c. Prewet the aluminum oxide by passing evaporate on the steam bath under nitrogen.
40 milliliters of isooctane through the col- Repeat the extraction four more times, re-
umn. Adjust the nitrogen pressure so that covering each extract in the 150-milliliter
the rate of descent of the isooctane coming beaker. Exercise care not to fill the beaker
off the column is between 1.5 to 2.5 milli- to such a capacity that solvent losses may
liters per minute. occur. Evaporate the combined
d. Just prior to the last of the isooctane nitromethane extracts to 1 milliliter of n-
reaching the top of the aluminum oxide bed, hexadecane residue containing the
add 10 milliliters of the isooctane solution nitromethane-soluble mineral oil extrac-
containing 5.0 milligrams of chrysene per tives. (NOTE: Complete removal of the
liter. nitromethane is essential. This can be as-
e. Continue percolation until the isooctane sured by two successive additions of 5 milli-
is just above the aluminum oxide. Then add liters of isooctane and reevaporation.)
200 milliliters of a mixture of benzene and 3. Remove the beaker from the steam bath
isooctane (331⁄3 percent benzene and 662⁄3 per- and allow to cool.
cent isooctane by volume) to the reservoir 4. Weigh 50 grams ±1 gram of activated alu-
and continue percolation. minum oxide and pack into the
f. Continue percolation, collecting the chromatographic column (1.3 centimeters ×
eluates (40 milliliters of the prewet solution, 75 centimeters) described under ‘‘Apparatus’’
10 milliliters of the sample solution, and 200 in C under I above. (NOTE: A small plug of
milliliters of the gradient solution) in the glass wool is placed at the column exit to
250-milliliter graduated cylinder until the prevent the aluminum oxide from passing
level of the gradient solution is just above through the column. After adding aluminum
the aluminum oxide. Add 200 milliliters of oxide, tap the column lightly to remove air
the eluting solution of benzene and isooctane voids. All percolations using aluminum oxide
(90 percent benzene and 10 percent isooctane are performed under nitrogen pressure. The
by volume) to the column and continue col- 500-milliliter reservoir described under ‘‘Ap-
lecting until a total of 250 milliliters of solu- paratus’’ in E under I above is to be used to
tion has been obtained. This may be dis- hold the elution solvents.)
carded. Now begin to collect the final eluate. 5. Prewet the column by adding 40 milli-
g. Place a 100-milliliter graduated cylinder liters of isooctane to the column. Adjust ni-
under the column and continue the percola- trogen pressure so that rate of descent of the
426
isooctane coming off the column is 2.0 to 3.0 glass-stoppered Erlenmeyer flask. Add to the
milliliters per minute. Be careful to main- silica gel 46.2 grams (41 milliliters) of
tain the level of solvent in the reservoir to nitromethane. Stopper and shake the flask
prevent air from entering the aluminum vigorously until no lumps of silica gel are
oxide bed. New or additional solvent is added observed and then shake occasionally during
just before the last portion of the previous a period of 1 hour. The resultant
solvent enters the bed. To minimize possible nitromethane-treated silica gel is 29 weight-
photo-oxidation effects, the following proce- percent nitro-methane and 71 weight-percent
dures (steps 6 through 18) shall be carried out silica gel.
in subdued light. 15. Place a small plug of glass wool in the
6. Before the last of the isooctane reaches tapered end of the 1.7 centimeters outside di-
the top of the aluminum oxide bed, release ameter × 115 centimeters column, described
the nitrogen pressure and turn off the stop- under ‘‘Apparatus’’ in D of I above, adjacent
cock on the column. Transfer the n-hexa- to the stopcock to prevent silica gel from
decane residue from the 150-milliliter beaker passing through the stopcock. Pack the
from procedure step 3 above onto the col- nitromethane-treated silica gel into the col-
umn, using several washes of isooctane (total umn, tapping lightly. The resultant silica gel
volume of washes should be no greater than bed should be about 95 centimeters in depth.
10–15 milliliters). Place into a flask 170 milliliters of isooctane
7. Open the stopcock and continue percola- saturated with nitromethane.
tion until the isooctane is about 1 centi- 16. Place a 100-milliliter graduated cyl-
meter above the top of the aluminum oxide inder under the column and transfer the res-
bed. Add 200 milliliters of isooctane to the idue from the beaker in procedure step 13
reservoir, and continue the percolation at above with several washes of the 170 milli-
the specified rate. liters of isooctane, saturated with
8. Just before the isooctane surface reaches nitromethane, onto the top of the column.
the top of the aluminum oxide bed, add 200 (Total volume of washes should be no greater
milliliters of a mixture of benzene and iso- than 10 to 15 milliliters.) Permit isooctane
octane (331⁄3 percent benzene and 662⁄3 percent solution to enter the silica gel bed until the
isooctane by volume) to the reservoir, and liquid level is at the top bed level. Place the
continue the percolation. remaining amount of the 170 milliliters of
9. Just before the surface of this mixture isooctane, saturated with nitromethane, in
reaches the top of the aluminum oxide bed, the reservoir above the bed for percolation
release the nitrogen pressure, turn off the through the silica gel. Apply nitrogen pres-
stopcock, and discard all the elution solvents sure to the top of the column, adjusting the
collected up to this point. pressure so that the isooctane is collected at
10. Add to the reservoir 300 milliliters of a the rate of 2.5 to 3.5 milliliters per minute,
mixture of benzene and isooctane (90 percent and percolate isooctane through the bed
benzene and 10 percent isooctane by volume), until a quantity of 75.0 milliliters of eluate is
place a 25-milliliter graduated cylinder collected. Discard the 75 milliliters of eluate.
under the column, continue the percolation Turn off the stopcock and add 250 milliliters
until 20 milliliters of eluate has been col- of benzene to the reservoir above the bed.
lected, and then discard the eluate. Use a 400-milliliter beaker to collect the re-
11. At this point, place a clean 250-milli- maining eluate.
liter Erlenmeyer flask under the column. 17. Open the stopcock, renew the pressure,
Continue the percolation and collect all the and percolate the remaining isooctane and
remaining eluate. benzene through the column eluting the re-
(NOTE: Allow the column to drain com- maining aromatics. Transfer the eluate in
pletely. An increase in the nitrogen pressure small portions from the 400 milliliter beaker
may be necessary as the last of the solvent to a 150-milliliter beaker containing 1 milli-
comes off the column.) liter of n-hexadecane and evaporate on the
12. Place 1 milliliter of n-hexadecane into a steam bath under nitrogen. Rinse the 400-
150-milliliter beaker. Place this onto a steam milliliter beaker well with small portions of
bath under a nitrogen stream and transfer in isooctane to obtain a complete transfer.
small portions the eluate from step 11 above. (NOTE: Complete removal of the
Wash out the Erlenmeyer flask with small nitromethane and benzene is essential. This
amounts of benzene and transfer to the evap- can be assured by successive additions of 5
oration beaker. Evaporate until only 1 milli- milliliters of isooctane and reevaporation.)
liter of hexadecane residue remains. (NOTE: 18. Transfer the residue with several wash-
Complete removal of the benzene is essen- es of isooctane into a 200-milliliter volu-
tial. This can be assured by two successive metric flask. Add isooctane to mark.
additions of 5 milliliters of isooctane and re- 19. Record the spectrum of the sample solu-
evaporation.) tion in a 1-centimeter cell compared to iso-
13. Remove the beaker from the steam bath octane from 270 to 400 mμ. After making nec-
and cool. essary corrections in the spectrum for cell
14. Place a sample of 113.5 grams activated differences and for the blank absorbance,
100- 200-mesh silica gel in a 500-milliliter record the maximum absorbance in each of
427
§ 178.3650 21 CFR Ch. I (4–1–11 Edition)
the wavelength intervals (mμ), 280–299, 300– fied wavelength intervals shall not exceed
319, 320–359, 360–400. the limits prescribed in paragraph (d)(1)(ii)
a. If the spectrum then shows no discern- of this section.
ible peak corresponding to the absorbance d. If the spectrum as a whole of the sample
maximum of the pyrene reference standard solution is in any respect clearly incompat-
solution at 334 mμ, the maximum ible with the presence of pyrene as the
absorbances in the respective wavelength in- source of the peak at 334 mμ, then the max-
tervals recorded shall not exceed those pre- imum absorbances in the respective wave-
scribed in paragraph (d)(1)(ii) of this section. length intervals without correction for any
b. If such a peak is evident in the spectrum assumed pyrene content shall not exceed the
of the sample solution, and the spectrum as limits prescribed in paragraph (d)(1)(ii) of
a whole is not incompatible with that of a this section.
pyrene contaminant yielding such a peak of
the observed absorbance, calculate the con- [42 FR 14609, Mar. 15, 1977, as amended at 47
centration of pyrene that would yield this FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19,
peak (334 m) by the base-line technique de- 1984; 54 FR 24898, June 12, 1989]
scribed in ASTM method E169–63 (Re-
approved 1981), ‘‘Standard Recommended § 178.3650 Odorless light petroleum hy-
Practices for General Techniques of Ultra- drocarbons.
violet Quantitative Analysis,’’ which is in- Odorless light petroleum hydro-
corporated by reference. The availability of
carbons may be safely used, as a com-
this incorporation by reference is given in
paragraph (b)(1)(i) of this section. Correct ponent of nonfood articles intended for
each of the maximum absorbances in the re- use in contact with food, in accordance
spective specified wavelength intervals by with the following prescribed condi-
subtracting the absorbance due to pyrene, tions:
determined as follows: (a) The additive is a mixture of liquid
hydrocarbons derived from petroleum
Cp × Sa or synthesized from petroleum gases.
Absorbance due to pyrene =
The additive is chiefly paraffinic,
Sp isoparaffinic, or naphthenic in nature.
where: (b) The additive meets the following
Cp=Calculated concentration of pyrene in specifications:
sample solution; (1) Odor is faint and not kerosenic.
Sp=Concentration of pyrene reference stand-
ard solution in same units of concentra-
(2) Initial boiling point is 300 °F min-
tion; imum.
Sa=Absorbance of pyrene reference standard (3) Final boiling point is 650 °F max-
solution at wavelength of maximum ab- imum.
sorbance of sample solution in the respec- (4) Ultraviolet absorbance limits de-
tive specified wavelength intervals. termined by method specified in
Also calculate the pyrene content of the § 178.3620(b)(1)(ii), as follows:
oil sample in parts per million as follows:
Maximum
Pyrene content ( 200/1000 ) × C absorb-
= = 10 C Wavelength (Mμ) ance per
(p. p. m.) 20/1000
centimeter
optical
pathlength
where:
C=Calculated concentration of pyrene in mil- 280 to 289 ........................................................... 4.0
ligrams per liter of sample solution. 290 to 299 ........................................................... 3.3
c. The pyrene content so determined shall 300 to 329 ........................................................... 2.3
not exceed 25 p.p.m. The maximum 330 to 360 ........................................................... .8
absorbances corrected for pyrene content as
described in this step 19 for each of the speci- (c) The additive is used as follows:
Use Limitations
As a plasticizer and absorber oil in the manufacture of In an amount not to exceed that required to produce intended
polyolefin articles authorized for food contact use. effect, consistent with good manufacturing practice.
As a lubricant of fibers of textiles authorized for food contact At a use level not to exceed 0.15 percent by weight of finished
use. fibers.
As a component of adhesives ..................................................... Complying with § 175.105 of this chapter.
As a defoamer in the manufacture of paper and paperboard .... Complying with § 176.210 of this chapter.
As a defoamer in coatings .......................................................... Complying with § 176.200 of this chapter.

ER01JA93.408</GPH>
428
ER01JA93.407</GPH>
§ 178.3690 Pentaerythritol adipate-ste- NARA, call 202–741–6030, or go to: http://

arate. www.archives.gov/federallregister/
Pentaerythritol adipate-stearate codeloflfederallregulations/
identified in paragraph (a) of this sec- ibrllocations.html.
tion may be safely used as a lubricant (3) Saponification number of 270–280
in the fabrication of rigid and semi- as determined by ASTM method D1387–
rigid polyvinyl chloride and/or vinyl 78, ‘‘Standard Test Method for Acid
chloride-propylene copolymers com- Number (Empirical) of Synthetic and
plying with § 177.1980 of this chapter Natural Waxes’’ (Revised 1978), which is
used as articles or components of arti- incorporated by reference. Copies are
cles that contact food, excluding food available from American Society for
with alcohol content greater than 8 Testing and Materials (ASTM), 100
percent under conditions of use of E, F, Barr Harbor Dr., West Conshohocken,
and G described in table 2 in § 175.300(d) Philadelphia, PA 19428-2959, or avail-
of this chapter, subject to the provi- able for inspection at the National Ar-
sions of this section. chives and Records Administration
(a) Identity. For the purpose of this (NARA). For information on the avail-
section, pentaerythritol adipate-stea- ability of this material at NARA, call
rate is an ester of pentaerythritol with 202–741–6030, or go to: http://
adipic acid and stearic acid and its as- www.archives.gov/federallregister/
sociated fatty acids (chiefly palmitic), codeloflfederallregulations/
with adipic acid comprising 14 percent ibrllocations.html.
and stearic acid and its associated (4) Iodine number not to exceed 2 as
acids (chiefly palmitic) comprising 71 determined by Iodine Absorption Num-
percent of the organic moieties. ber, Hanus Method, of the ‘‘Official
(b) Specifications. Pentaerythritol adi- Methods of Analysis of the Association
pate-stearate has the following speci- of Official Analytical Chemists,’’ sec-
fications: tions 28.018–28.019, 13th Ed. (1980), which
(1) Melting point (dropping) of 55–58 is incorporated by reference. Copies
°C as determined by ASTM method may be obtained from the AOAC
D566–76 (Reapproved 1982), ‘‘Standard INTERNATIONAL, 481 North Frederick
Test Method for Dropping Point of Lu- Ave., suite 500, Gaithersburg, MD 20877,
bricating Grease,’’ which is incor- or may be examined at the National
porated by reference. Copies may be Archives and Records Administration
obtained from the American Society (NARA). For information on the avail-
for Testing Materials, 100 Barr Harbor ability of this material at NARA, call
Dr., West Conshohocken, Philadelphia, 202–741–6030, or go to: http://
PA 19428-2959, or may be examined at www.archives.gov/federallregister/
the National Archives and Records Ad- codeloflfederallregulations/
ministration (NARA). For information ibrllocations.html.
on the availability of this material at (c) The total amount of ester (cal-
NARA, call 202–741–6030, or go to: http:// culated as free pentaerythritol) shall
www.archives.gov/federallregister/ not exceed 0.4 percent by weight of the
codeloflfederallregulations/ polyvinyl chloride and/or the vinyl
ibrllocations.html. chloride-propylene copolymers com-
(2) Acid value not to exceed 15 as de- plying with § 177.1980.
termined by ASTM method D1386–78, [45 FR 1018, Jan. 4, 1980, as amended at 47 FR
‘‘Standard Test Method for Saponifica- 11848, Mar. 19, 1982; 49 FR 10112, Mar. 19, 1984;
tion Number (Empirical) of Synthetic 54 FR 24898, June 12, 1989; 57 FR 18082, Apr.
and Natural Waxes’’ (Revised 1978), 29, 1992; 70 FR 40880, July 15, 2005; 70 FR 67651,
which is incorporated by reference. Nov. 8, 2005]
Copies are available from American So-
ciety for Testing and Materials § 178.3700 Petrolatum.
(ASTM), 100 Barr Harbor Dr., West Petrolatum may be safety used as a
Conshohocken, Philadelphia, PA 19428- component of nonfood articles in con-
2959, or available for inspection at the tact with food, in accordance with the
National Archives and Records Admin- following conditions:

istration (NARA). For information on (a) Petrolatum complies with the
the availability of this material at specifications set forth in the United
429
§ 178.3710 21 CFR Ch. I (4–1–11 Edition)
States Pharmacopeia XX (1980) for Ultraviolet absorbance per centi-

white petrolatum or in the National meter pathlength:
Formulary XV (1980) for yellow petro-
latum. Millimicrons Maximum
(b) Petrolatum meets the following 280 to 289 ........................................................... 0.15
ultraviolet absorbance limits when 290 to 299 ........................................................... .12
subjected to the analytical procedure 300 to 359 ........................................................... .08
described in § 172.886(b) of this chapter: 360 to 400 ........................................................... .02
Ultraviolet absorbance per centi-
meter pathlength: (c) Petroleum wax may contain any
antioxidant permitted in food by regu-
Millimicrons Maximum
lations issued in accordance with sec-
280 to 289 ........................................................... 0.25 tion 409 of the act, in an amount not
290 to 299 ........................................................... .20 greater than that required to produce
300 to 359 ........................................................... .14
360 to 400 ........................................................... .04
its intended effect.
(d) Petroleum wax may contain a
(c) It is used or intended for use as a total of not more than 1 weight percent
protective coating of the surfaces of of residues of the following polymers
metal or wood tanks used in fermenta- when such residues result from use of
tion process, in an amount not in ex- the polymers as processing aids (filter
cess of that required to produce its in- aids) in the production of the petro-
tended effect. leum wax: Homopolymers and/or co-
(d) Petrolatum as defined by this sec- polymers derived from one or more of
tion may be used for the functions de- the mixed n-alkyl (C12, C14, C16, and C18)
scribed and within the limitations pre- methacrylate esters where the C12 and
scribed by specific regulations in parts C14 alkyl groups are derived from coco-
175, 176, 177, and 178 of this chapter nut oil and the C16 and C18 groups are
which prescribe uses of petrolatum. derived from tallow.
For the purpose of cross-reference, (e) Petroleum wax may contain 2-hy-
such specific regulations include: droxy-4-n-octoxybenzophenone as a sta-
§§ 175.105, 175.125, 175.300, 176.170, 176.200, bilizer at a level not to exceed 0.01
176.210, 177.2600, 177.2800, and 178.3570 of weight percent of the petroleum wax.
this chapter. (f) Petroleum wax may contain
(e) Petrolatum may contain any anti- poly(alkylacrylate) (CAS Reg. No.
oxidant permitted in food by regula- 27029–57–8), as described in § 172.886(c)(2)
tions issued pursuant to section 409 of of this chapter, as a processing aid in
the act, in an amount not greater than the manufacture of petroleum wax.
that required to produce its intended
effect. [42 FR 14609, Mar. 15, 1977, as amended at 51
FR 19545, May 30, 1986]
FR 10113, Mar. 19, 1984; 55 FR 12172, Apr. 2, § 178.3720 Petroleum wax, synthetic.
1990]
Synthetic petroleum wax may be
§ 178.3710 Petroleum wax. safely used in applications and under
Petroleum wax may be safely used as the same conditions where naturally
a component of nonfood articles in con- derived petroleum wax is permitted in
tact with food, in accordance with the subchapter B of this chapter as a com-
following conditions: ponent of articles intended to contact
(a) Petroleum wax is a mixture of food, provided that the synthetic petro-
solid hydrocarbons, paraffinic in na- leum wax meets the definition and
ture, derived from petroleum, and re- specifications prescribed in § 172.888 of
fined to meet the specifications pre- this chapter.
scribed in this section.
(b) The petroleum wax meets the fol- § 178.3725 Pigment dispersants.
lowing ultraviolet absorbance limits Subject to the provisions of this reg-
when subjected to the analytical proce- ulation, the substances listed in this
dure described in § 172.886(b) of this section may be safely used as pigment

chapter. dispersants in food-contact materials.
430
Dimethylolpropionic acid (CAS Reg. No. 4767–03–7) ................ For use only at levels not to exceed 0.45 percent by weight of
the pigment. The pigmented articles may contact all foods
under conditions of use A through H as described in Table 2
of § 176.170(c) of this chapter.
Phosphorylated tall oil fatty acids (CAS Reg. No. 68604–99–9), For use only at levels not to exceed 1.0 percent by weight of
prepared by the reaction of dimethyl hydrogen phosphite the pigment. The pigmented polymeric films may contact all
with tall oil fatty acids. food under conditions of use D, E, F, and G described in
Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, compd. For use only at levels not to exceed 0.45 percent by weight of
with 1,1′,1″-nitrilotris [2-propanol] (1:1) (CAS Reg. No. the pigment. The pigmented articles may contact all food
221281–21–6). under conditions of use A through H as described in Table 2
of § 176.170(c) of this chapter.
Siloxanes and silicones; cetylmethyl, dimethyl, methyl 11- For use only at levels not to exceed 0.5 percent by weight of
methoxy-11-oxoundecyl (CAS Reg. No. 155419–59–3). the pigment. The pigmented polymers may contact all foods
under conditions of use C, D, E, F, and G described in Table
2 of § 176.170(c) of this chapter.
Trimethylolethane (CAS Reg. No. 77–85–0) .............................. For use only at levels not to exceed 0.45 percent by weight of
inorganic pigment. The pigmented articles may contact all
food under conditions of use A through H described in Table
2 of § 176.170(c) of this chapter.
[61 FR 43157, Aug. 21, 1996, as amended at 63 FR 35799, July 1, 1998; 64 FR 48292, Sept. 3, 1999;
64 FR 72273, Dec. 27, 1999; 65 FR 52909, Aug. 31, 2000]
§ 178.3730 Piperonyl butoxide and graph (b) of this section may be safely
pyrethrins as components of bags. used as plasticizers in polymeric sub-
Piperonyl butoxide in combination stances used in the manufacture of ar-
with pyrethrins may be safely used for ticles or components of articles in-
insect control on bags that are intended for use in producing, manufac-
tended for use in contact with dried turing, packing, processing, preparing,
feed in compliance with §§ 561.310 and treating, packaging, transporting, or
561.340 of this chapter, or that are in- holding food.
tended for use in contact with dried (a) The quantity used shall not ex-
food in compliance with §§ 193.60 and ceed the amount reasonably required
193.390 of this chapter. to accomplish the intended technical
§ 178.3740 Plasticizers in polymeric effect.
substances. (b) List of substances:
Subject to the provisions of this reg-
ulation, the substances listed in para-
Butylbenzyl phthalate .............................................. For use only:

1. As provided in §§ 175.105 and 176.180 of this chapter.
2. In polymeric substances used in food-contact articles complying with
§ 175.300, § 175.320, or § 176.170 of this chapter: Provided, That the
butyl benzyl phthalate contains not more than 1 percent by weight of
dibenzyl phthalate.
3. In polymeric substances used in other permitted food-contact articles:
Provided, That the butyl benzyl phthalate contains not more than 1 per-
cent by weight of dibenzyl phthalate; and Provided further, That the fin-
ished food-contact article, when extracted with the solvent or solvents
characterizing the type of food and under the conditions of time and tem-
perature characterizing the conditions of its intended use as determined
from tables 1 and 2 of § 175.300(d) of this chapter, shall yield net chloro-
form-soluble extractives not to exceed 0.5 mg. per square inch, as deter-
mined by the methods prescribed in § 175.300(e) of this chapter.
1,3-Butylene glycoladipic acid polyester (1,700– For use at levels not exceeding 33 percent by weight of polyvinyl chloride
2,200 molecular weight) terminated with a 16 homopolymers used in contact with food (except foods that contain more
percent by weight mixture of myristic, palmitic, than 8 percent of alcohol) at temperatures not to exceed room tempera-
and stearic acids. ture. The average thickness of such homopolymers in the form in which
they contact food shall not exceed 0.004 inch.
431
§ 178.3740 21 CFR Ch. I (4–1–11 Edition)
Di(C7, C9-alkyl) adipate, in which the C7, C9-alkyl For use only under the conditions listed below, and excluding use as a
groups are derived from linear alpha olefins by component of resinous and polymeric coatings described in § 175.300 of
the oxo process. this chapter.
1. At levels not to exceed 24 percent by weight of permitted vinyl chloride
homo- and/or copolymers used in contact with nonfatty foods. The aver-
age thickness of such polymers in the form in which they contact food
shall not exceed 0.005 inch.
2. At levels not to exceed 24 pct by weight of permitted vinyl chloride
homo- and/or copolymers used in contact, under conditions of use F and
G described in table 2 of § 176.170(c) of this chapter, with fatty foods
having a fat and oil content not exceeding a total of 40 pct by weight.
The average thickness of such polymers in the form in which they con-
tact food shall not exceed 0.005 inch.
3. At levels not exceeding 35 pct by weight of permitted vinyl chloride
age thickness of such polymer in the form in which they contact food
G described in table 2 of § 176.170(c) of this chapter with fatty foods hav-
ing a fat and oil content not exceeding a total of 40 pct by weight. The
average thickness of such polymers in the form in which they contact
food shall not exceed 0.002 inch.
Di-n-alkyl adipate made from C6 C8-C10 (predomi- For use only:
nately C8 and C10) or C8-C10 synthetic fatty alco- 1. At levels not exceeding 24 pct by weight of permitted vinyl chloride
hols complying with § 172.864 of this chapter. homo- and/or copolymers used in contact with nonfatty foods. The aver-
The average thickness of such polymers in the form in which they con-
tact food shall not exceed 0.005 inch.
The average thickness of such polymers in which they contact food shall
Dicyclohexyl phthalate ............................................ For use only:
1. As provided in §§ 175.105, 176.170, 176.180, and 177.1200 of this chap-
ter.
2. Alone or in combination with other phthalates, in plastic film or sheet pre-
pared from polyvinyl acetate, polyvinyl chloride, and/or vinyl chloride co-
polymers complying with § 177.1980 of this chapter. Such plastic film or
sheet shall be used in contact with food at temperatures not to exceed
room temperature and shall contain no more than 10 pct by weight of
total phthalates, calculated as phthalic acid.
Di(2-ethylhexyl) adipate ..........................................
432
Diisononyl adipate ................................................... For use only:

homo- and/or copolymers used in contact with nonfatty, nonalcoholic
foods. The average thickness of such polymers in the form in which they
contact food shall not exceed 0.005 inch.
homo- and/or copolymers used in contact under conditions of use F and
G described in table 2 of § 176.170(c) of this chapter with fatty, non-
alcoholic foods having a fat and oil content not exceeding a total of 30
pct by weight. The average thickness of such polymers in the form in
which they contact food shall not exceed 0.005 inch.
foods. The average thickness of such polymers in the form in which they
G described in table 2 of § 176.170(c) of this chapter with fatty, non-
alcoholic foods having a fat and oil content not exceeding a total of 40
pct by weight. The average thickness of such polymers in the form in
Diisononyl phthalate ................................................ For use only at levels not exceeding 43 pct by weight of permitted vinyl
chloride homo- and/or copolymers used in contact with food only of the
types identified in § 176.170(c) of this chapter, table 1, under Categories
I, II, IV-B, and VIII, at temperatures not exceeding room temperature. The
average thickness of such polymers in the form in which they contact
food shall not exceed 0.005 inch.
Di(2-ethylhexyl) azelate ........................................... For use only:
food. The average thickness of such polymers in the form in which they
G described in table 2 of § 176.170(c) of this chapter, with fatty, non-
alcoholic food having a fat and oil content not exceeding a total of 30
percent by weight. The average thickness of such polymers in the form in
Di-n-hexylazelate ..................................................... For use only:
1. In polymeric substances used in contact with nonfatty food.
2. In polymeric substances used in contact with fatty food and limited to
use at levels not exceeding 15 pct by weight of such polymeric sub-
stance except as provided under limitation 3.
3. At levels greater than 15 but not exceeding 24 pct by weight of permitted
vinyl chloride homo- and/or copolymers used in contact, under conditions
of use F or G described in table 2 of § 176.170(c) of this chapter, with
fatty food having a fat and oil content not exceeding a total of 30 pct by
weight. The average thickness of such polymers in the form in which they
Dihexyl phthalate ..................................................... For use only:
2. In articles that contact food only of the types identified in § 176.170(c) of
this chapter, table 1, under Categories I, II, IV-B, VI-B, and VIII.
Diphenyl phthalate .................................................. For use only:
2. Alone or in combination with other phthalates, in plastic film or sheet pre-
pared from polyvinyl acetate, polyvinyl chloride, and/or vinyl chloride co-
polymers complying with § 177.1980 of this chapter. Such plastic film or
sheet shall be used in contact with food at temperatures not to exceed
room temperature and shall contain no more than 10 pct by weight of
total phthalates, calculated as phthalic acid.
Epoxidized butyl esters of linseed oil fatty acids .... Iodine number, maximum 5; oxirane oxygen, minimum 7.8 pct.
Epoxidized linseed oil ............................................. Iodine number, maximum 5; oxirane oxygen, minimum 9-pct.
Mineral oil, white.
433
§ 178.3750 21 CFR Ch. I (4–1–11 Edition)
Polybutene, hydrogenated (minimum viscosity at For use only:

99 °F, 39 Saybolt Universal seconds, as deter- 1. In polymeric substances used in contact with non-fatty food.
mined by ASTM methods D445–82 (‘‘Standard 2. In polyethylene complying with § 177.1520 of this chapter and used in
Test Method for Kinematic Viscosity of Trans- contact with fatty food, provided that the hydrogenated polybutene is
parent and Opaque Liquids (and the Calculation added in an amount not to exceed 0.5 pct by weight of the polyethylene,
of Dynamic Viscosity)’’) and D2161–82 (‘‘Stand- and further provided that such plasticized polyethylene shall not be used
ard Method for Conversion of Kinematic Vis- as a component of articles intended for packing or holding food during
cosity to Saybolt Universal Viscosity or to cooking.
Saybolt Furol Viscosity’’), and bromine number 3. In polystyrene complying with § 177.1640 of this chapter and used in
of 3 or less, as determined by ASTM method contact with fatty food, provided that the hydrogenated polybutene is
D1492–78 (‘‘Standard Test Method for Bromine added in an amount not to exceed 5 pct by weight of the polystyrene,
Index of Aromatic Hydrocarbons by Coulometric and further provided that such plasticized polystyrene shall not be used
Titration’’), which are incorporated by reference. as a component of articles intended for packing or holding food during
Copies may be obtained from the American So- cooking.
ciety for Testing Materials, 100 Barr Harbor Dr.,
West Conshohocken, Philadelphia, PA 19428-
2959, or may be examined at the National Ar-
chives 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/federallregister/
Polyisobutylene (mol weight 300–5,000) ................ For use in polyethylene complying with § 177.1520 of this chapter, provided
that the polyisobutylene is added in an amount not exceeding 0.5 pct by
weight of the polyethylene, and further provided that such plasticized pol-
yethylene shall not be used as a component of articles intended for pack-
ing or holding food during cooking.
Polyisobutylene complying with § 177.1420 of this
chapter.
Polypropylene glycol (CAS registry No. 25322–69– For use only in polystyrene plastics, identified in § 177.1640(a)(1), in an
4) (minimum mean molecular weight 1,200). amount not to exceed 6 pct by weight of the finished food-contact article.
Propylene glycol azelate (average mol. weight For use only at levels not exceeding 41 pct by weight of permitted polyvinyl
3,000). chloride coatings. Such coatings shall be used only as bulk food contact
surfaces of articles intended for repeated use, complying with § 177.2600
of this chapter.
Triethylene glycol .................................................... Diethylene glycol content not to exceed 0.1 pct.
2,2,4-Trimethyl-1,3-pentanediol diisobutyrate ......... For use only in cellulosic plastics in an amount not to exceed 15 pct by
weight of the finished food-contact article, provided that the finished plas-
tic article contacts food only of the types identified in § 176.170(c) of this
chapter, table 1, under Categories I, II, VI-B, VII-B, and VIII.
(c) The use of the plasticizers in any (b) It contains no more than 0.2 per-
polymeric substance or article subject cent total by weight of ethylene and
to any regulation in parts 174, 175, 176, diethylene glycols if its mean molec-
177, 178 and 179 of this chapter must ular weight is 350 or higher and no
comply with any specifications and more than 0.5 percent total by weight
limitations prescribed by such regula- of ethylene and diethylene glycols if its
tion for the finished form of the sub- mean molecular weight is below 350,
stance or article. when tested by the analytical methods
prescribed in § 172.820(b) of this chapter.
FR 44223, Sept. 2, 1977; 45 FR 56052, Aug. 22, (c) The provisions of paragraph (b) of
1980; 48 FR 5748, Feb. 15, 1984; 49 FR 10113, this section are not applicable to poly-
Mar. 19, 1984; 51 FR 47011, Dec. 30, 1986] ethylene glycols used in food-pack-
aging adhesives complying with
§ 178.3750 Polyethylene glycol (mean § 175.105 of this chapter.
molecular weight 200–9,500).
Polyethylene glycol identified in this § 178.3760 Polyethylene glycol (400)
section may be safely used as a compo- monolaurate.
nent of articles intended for use in con- Polyethylene glycol (400)
tact with food, in accordance with the monolaurate containing not more than
following prescribed conditions: 0.1 percent by weight of ethylene and/
(a) The additive is an addition poly- or diethylene glycol may be used at a

mer of ethylene oxide and water with a level not to exceed 0.3 percent by
mean molecular weight of 200 to 9,500. weight of twine as a finish on twine to
434
be used for tying meat provided the on the availability of this material at
twine fibers are produced from nylon NARA, call 202–741–6030, or go to: http://
resins complying with § 177.1500 of this www.archives.gov/federallregister/
chapter. codeloflfederallregulations/
ibrllocations.html.) using as solvent xy-
§ 178.3770 Polyhydric alcohol esters of lene-ethyl alcohol in a 2:1 ratio instead
oxidatively refined (Gersthofen of toluene-ethyl alcohol in a 2:1 ratio.
process) montan wax acids. (3) Saponification value 100–160, as
Polyhydric alcohol esters of determined by ASTM method D1387–78
oxidatively refined (Gersthofen proc- (‘‘Standard Test Method for Saponi-
ess) montan wax acids identified in this fication Number (Empirical) of Syn-
section may be safely used as compo- thetic and Natural Waxes’’ (Revised
nents of articles intended for use in 1978), which is incorporated by ref-
contact with food in accordance with erence; copies are available from Amer-
the following prescribed conditions: ican Society for Testing and Materials
(a) The polyhydric alcohol esters (ASTM), 100 Barr Harbor Dr., West
identified in this paragraph may be Conshohocken, Philadelphia, PA 19428-
used as lubricants in the fabrication of 2959, or available for inspection at the
vinyl chloride plastic food-contact ar- National Archives and Records Admin-
ticles prepared from polyvinyl chloride istration (NARA). For information on
and/or from vinyl chloride copolymers the availability of this material at
complying with § 177.1980 of this chap- NARA, call 202–741–6030, or go to: http://
ter. Such esters meet the following www.archives.gov/federallregister/
specifications and are produced by par- codeloflfederallregulations/
tial esterification of oxidatively re- ibrllocations.html.) using xylene-ethyl
fined (Gersthofen process) montan wax alcohol in a 2:1 ratio instead of ethyl
acids by either ethylene glycol or 1,3- alcohol in preparation of potassium hy-
butanediol with or without neutraliza- droxide solution.
tion of unreacted carboxylic groups (4) Ultraviolet absorbance limits as
with calcium hydroxide: follows, as determined by the analyt-
(1) Dropping point 76°–105 °C, as de- ical method described in this subpara-
termined by ASTM method D566–76 graph:
(Reapproved 1982), ‘‘Standard Test Ultraviolet absorbance per centi-
Method for Dropping Point of Lubri- meter pathlength.
cating Grease,’’ which is incorporated Millimicrons Maximum
by reference. Copies may be obtained
from the American Society for Testing 280 to 289 ........................................................... 0.07
290 to 299 ........................................................... .06
Materials, 100 Barr Harbor Dr., West 300 to 359 ........................................................... .04
Conshohocken, Philadelphia, PA 19428- 360 to 400 ........................................................... .01
2959, or may be examined at the Na-
tional Archives and Records Adminis- ANALYTICAL METHOD
tration (NARA). For information on
GENERAL INSTRUCTIONS
the availability of this material at
NARA, call 202–741–6030, or go to: http:// Because of the sensitivity of the test, the
www.archives.gov/federallregister/ possibility of errors arising from contamina-
codeloflfederallregulations/ tion is great. It is of the greatest importance
that all glassware be scrupulously cleaned to
ibrllocations.html. remove all organic matter such as oil,
(2) Acid value 10–20, as determined by grease, detergent residues, etc. Examine all
ASTM method D1386–78 (‘‘Standard glassware, including stoppers and stopcocks,
Test Method for Acid Number (Empir- under ultraviolet light to detect any residual
ical) of Synthetic and Natural Waxes’’ fluorescent contamination. As a pre-
(Revised 1978), which is incorporated by cautionary measure it is recommended prac-
reference; copies are available from tice to rinse all glassware with purified iso-
American Society for Testing and Ma- octane immediately before use. No grease is
to be used on stopcocks or joints. Great care
terials (ASTM), 100 Barr Harbor Dr., to avoid contamination of wax samples in
West Conshohocken, Philadelphia, PA
handling and to assure absence of any extra-

19428-2959, or available for inspection at neous material arising from inadequate
the National Archives and Records Ad- packaging is essential. Because some of the
ministration (NARA). For information polynuclear hydrocarbons sought in this test
435
§ 178.3770 21 CFR Ch. I (4–1–11 Edition)
are very susceptible to photo-oxidation, the Absorbance accuracy, 1 ±0.05 at 0.4 absorb-
entire procedure is to be carried out under ance.
subdued light. Wavelength repeatability, ±0.2 milli-
micron.
APPARATUS
Wavelength accuracy, ±1.0 millimicron.
Separatory funnels. 250-milliliter, 500-milli- Recording time, 50 seconds.
liter, 1,000-milliliter, and preferably 2,000- Time constant, 0.6 second.
milliliter capacity, equipped with tetra- Sensitivity, 30.
fluoroethylene polymer stopcocks. Ordinate scale, 90–100 percent transmission
Reservoir. 1,000-milliliter capacity, through scale.
equipped with a 24/40 standard taper male fit- Abscissa scale, 8X.
ting at the bottom and a suitable balljoint at Nitrogen cylinder. Water-pumped or equiva-
the top. lent purity nitrogen in cylinder equipped
Chromatographic tube. 1,200 millimeters in with regulator and valve to control flow at 5
length, inside diameter to be 16.5 millimeters p.s.i.g.
±0.5 millimeter, equipped with a coarse, frit-
ted-glass disc, a tetrafluoroethylene polymer REAGENTS AND MATERIALS
stopcock, and a female 24/40 standard tapered
fitting at the opposite end. (Overall length of Organic solvents. All solvents used through-
the column with the female joint is 1,255 mil- out the procedure shall meet the specifica-
limeters.) The female fitting should be tions and tests described in this specifica-
equipped with glass hooks. tion. The isooctane and benzene designated
Disc. Tetrafluoroethylene polymer 2-inch in the list following this paragraph shall
diameter disc approximately 3⁄16-inch thick pass the following test:
with a hole bored in the center to closely fit To be specified quantity of solvent in a 250-
the stem of the chromatographic tube. milliliter Erlenmeyer flask, add 1 milliliter
Heating jackets. Conical, for 500-milliliter of purified n-hexadecane and evaporate on
and 1,000-milliliter separatory funnels. (Used the steam bath under a stream of nitrogen (a
with variable transformer heat control.) loose aluminum foil jacket around the flask
Suction flask. 250-milliliter or 500-milliliter will speed evaporation). Discontinue evapo-
filter flask. ration when not over 1 milliliter of residue
Condenser. 24⁄40 joints, fitted with a drying remains. (To the residue from benzene add a
tube, length optional. 10-milliliter portion of purified isooctane, re-
Evaporation flasks (optional). A 250-milli- evaporate, and repeat once to insure com-
liter or 500-milliliter capacity and a 1-liter plete removal of benzene.)
capacity all-glass flask equipped with stand- Alternatively, the evaporation time can be
ard taper stopper having inlet and outlet reduced by using the optional evaporation
tubes to permit passage of nitrogen across flask. In this case the solvent and n-hexa-
the surface of contained liquid to be evapo- decane are placed in the flask on the steam
rated. bath, the tube assembly is inserted, and a
Vacuum distillation assembly. All glass (for stream of nitrogen is fed through the inlet
purification of dimethyl sulfoxide) 2-liter tube while the outlet tube is connected to a
distillation flask with heating mantle; solvent trap and vacuum line in such a way
Vigreaux vacuum-jacketed condenser (or as to prevent any flow-back of condensate
equivalent) about 45 centimeters in length into the flask.
and distilling head with separable cold finger
condenser. Use of tetrafluoroethylene poly- 1 As determined by procedure using potas-
mer sleeves on the glass joints will prevent
sium chromate for reference standard and
freezing. Do not use grease on stopcocks or
described in National Bureau of Standards
joints.
Circular 484, Spectrometry, U.S. Department
Oil bath. Capable of heating to 90 °C. of Commerce (1949). The accuracy is to be de-
Spectrophotometric cells. Fused quartz cells, termined by comparison with the standard
optical pathlength in the range 1.000 centi- values at 290, 345, and 400 millimicrons. Cir-
meter ±0.005 centimeter. With distilled water cular 484 is incorporated by reference. Copies
in the cells, determine any absorbance dif- are available from the Center for Food Safe-
ferences. ty and Applied Nutrition (HFS–200), Food
Spectrophotometer. Spectral range 250 milli- and Drug Administration, 5100 Paint Branch
microns-400 millimicrons with spectral slit Pkwy., College Park, MD 20740, or available
width of 0.2 millimicron or less; under infor inspection at the National Archives and
strument operating conditions for these ab- Records Administration (NARA). For infor-
sorbance measurements. The spectrophotom- mation on the availability of this material
eter shall also meet the following perform-
at NARA, call 202–741–6030, or go to: http://

ance requirements: www.archives.gov/federallregister/
Absorbance repeatability, ±0.01 at 0.4 ab- codeloflfederallregulations/
sorbance. ibrllocations.html.
436
Dissolve the 1 milliliter of hexadecane res- nitrogen. Discontinue evaporation when not
idue in isooctane and make up to 25 milli- over 1 milliliter of residue remains. To the
liters volume. Determine the absorbance in residue, add a 10-milliliter portion of iso-
the 1-centimeter pathlength cells compared octane and reevaporate to 1 milliliter of
to isooctane as reference. The absorbance of hexadecane. Again, add 10 milliliters of iso-
the solution of the solvent residue (except octane to the residue and evaporate to 1 mil-
for methyl alcohol) shall not exceed 0.01 per liliter of hexadecane to insure complete re-
centimeter pathlength between 280 mμ and moval of all volatile materials. Dissolve the
400 mμ. 1 milliliter of hexadecane in isooctane and
Isooctane (2,2,4-trimethylpentane). Use 180 make to 25-milliliter volume. Determine the
milliliters for the test described in the pre- absorbance in 1-centimeter pathlength cells
ceding paragraph. Purify, if necessary, by compared to isooctane as reference. The ab-
passage through a column of activated silica sorbance of the solution should not exceed
gel (Grade 12, Davison Chemical Co., Balti- 0.02 per centimeter pathlength in the 280 mμ-
more, Md., or equivalent) about 90 centi- 400 mμ range. (NOTE: Difficulty in meeting
meters in length and 5 centimeters to 8 cen- this absorbance specification may be due to
timeters in diameter. organic impurities in the distilled water.
Benzene, A.C.S. reagent grade. Use 150 milli- Repetition of the test omitting the dimethyl
liters for the test. Purify, if necessary, by sulfoxide will disclose their presence. If nec-
distillation or otherwise. essary to meet the specification, purify the
n-Hexadecane, 99 percent olefin-free. Dilute water by redistillation, passage through an
1.0 milliliter of n-hexadecane to 25 milliliters ion-exchange resin, or otherwise.)
with isooctane and determine the absorbance Purify, if necessary, by the following pro-
in a 1-centimeter cell compared to isooctane cedure: To 1,500 milliliters of dimethyl sulf-
as reference point between 280 mμ-400 mμ. oxide in a 2-liter glass-stoppered flask, add
The absorbance per centimeter pathlength 6.0 milliliters of phosphoric acid and 50
shall not exceed 0.00 in this range. If nec- grams of Norit A (decolorizing carbon, alka-
essary, purify by filtering through a column line) or equivalent. Stopper the flask, and
containing 100 grams of aluminum oxide (use with the use of a magnetic stirrer (tetra-
same grade as described below) in the lower fluoroethylene polymer coated bar) stir the
half and 100 grams of activated silica gel in solvent for 15 minutes. Filter the dimethyl
the upper half keeping the column at 150 °C., sulfoxide through four thicknesses of fluted
for a period of 15 hours or overnight. The paper (18.5 centimeters, Schleicher &
first 100 milliliters of eluate are used. Purifi- Schuell, No. 597, or equivalent). If the initial
cation can also be accomplished by distilla- filtrate contains carbon fines, refilter
tion. through the same filter until a clear filtrate
Dimethyl sulfoxide. Pure grade, clear, is obtained. Protect the sulfoxide from air
water-white, m.p. 18° minimum. Dilute 120 and moisture during this operation by cov-
milliliters of dimethyl sulfoxide with 240 ering the solvent in the funnel and collection
milliliters of distilled water in a 500-milli- flask with a layer of isooctane. Transfer the
liter separatory funnel, mix and allow to filtrate to a 2-liter separatory funnel and
cool for 5–10 minutes. Add 40 milliliters of draw off the dimethyl sulfoxide into the 2-
isooctane to the solution and extract by liter distillation flask of the vacuum dis-
shaking the funnel vigorously for 2 minutes. tillation assembly and distill at approxi-
Draw off the lower aqueous layer into a sec- mately 3-millimeter Hg pressure or less. Dis-
ond 500-milliliter separatory funnel and re- card the first 200-milliliter fraction of the
peat the extraction with 40 milliliters of iso- distillate and replace the distillate collec-
octane. Draw off and discard the aqueous tion flask with a clean one. Continue the dis-
layer. Wash each of the 40-milliliter extrac- tillation until approximately 1 liter of the
tives three times with 50-milliliter portions sulfoxide has been collected.
of distilled water. Shaking time for each At completion of the distillation, the rea-
wash is 1 minute. Discard the aqueous lay- gent should be stored in glass-stoppered bot-
ers. Filter the first extractive through anhy- tles since it is very hygroscopic and will
drous sodium sulfate prewashed with iso- react with some metal containers in the
octane (see Sodium sulfate under ‘‘Reagents presence of air.
and materials’’ for preparation of filter), into Phosphoric acid. 85 percent A.C.S. reagent
a 250-milliliter Erlenmeyer flask, or option- grade.
ally into the evaporating flask. Wash the Aluminum oxide (80–200 mesh Woelm neutral
first separatory funnel with the second 40- activity grade 1 [Brockmann], Alupharm Chemi-
milliliter isooctane extractive, and pass cals, New Orleans, La., or equivalent). Pipette
through the sodium sulfate into the flask. 1 milliliter of distilled water into a dry 250-
Then wash the second and first separatory milliliter Erlenmeyer flask equipped with a
funnels successively with a 10-milliliter por- ground-glass stopper. Stopper the flask and
tion of isooctane, and pass the solvent rotate it in such a manner as to completely
through the sodium sulfate into the flask. wet out the inside surfaces. When this has
Add 1 milliliter of n-hexadecane and evapo- been done add 180 grams of the aluminum
rate the isooctane on the steam bath under oxide and shake until no lumps or wet spots
437
§ 178.3770 21 CFR Ch. I (4–1–11 Edition)
remain. Allow to stand at room temperature the wax redissolves. (Remove stopper from
for a period of 2 hours. At the end of this the funnel at intervals to release pressure.)
time the water should be evenly distributed When the wax is in solution, remove the fun-
throughout the aluminum oxide powder, and nel from the jacket and shake it vigorously
it should have the same free flowing prop- for 2 minutes. Set up three 250-milliliter
erties as the original material (flow velocity separatory funnels with each containing 30
with water 0.2 milliliter per minute). At this milliliters of preequilibrated isooctane.
point the aluminum oxide has an activity of After separation of the liquid phases, allow
1 as expressed in Brockmann degrees, and to cool until the main portion of the wax-iso-
the amount of added water is 0.5 percent by octane solution begins to show a precipitate.
volume. This product is used in toto and as Gently swirl the funnel when precipitation
is, without further screening. first occurs on the inside surface of the fun-
Sodium sulfate, anhydrous, A.C.S. reagent nel to accelerate this process. Carefully draw
grade, preferably in granular form. For each off the lower layer, filter it slowly through a
bottle of sodium sulfate reagent used, estab- thin layer of glass wool fitted loosely in a fil-
lish as follows the necessary sodium sulfate ter funnel into the first 250-milliliter sepa-
prewash to provide such filters required in ratory funnel, and wash in tandem with the
the method: Place approximately 35 grams of 30-milliliter portions of isooctane contained
anhydrous sodium sulfate in a 30-milliliter in the 250-milliliter separatory funnels.
coarse, fritted-glass funnel or in a 65-milli- Shaking time for each wash is 1 minute. Re-
meter filter funnel with glass wool plug; peat the extraction operation with two addi-
wash with successive 15-milliliter portions of tional portions of the sulfoxide-acid mixture,
the indicated solvent until a 15-milliliter replacing the funnel in the jacket after each
portion of the wash shows 0.00 absorbance extraction to keep the wax in solution and
per centimeter pathlength between 280 mμ washing each extractive in tandem through
and 400 mμ when tested as prescribed under the same three portions of isooctane.
‘‘Organic solvents.’’ Usually three portions Collect the successive extractives (300 mil-
of wash solvent are sufficient. liliters total) in a separatory funnel (pref-
erably 2-liter), containing 480 milliliters of
PROCEDURE distilled water, mix, and allow to cool for a
few minutes after the last extractive has
Before proceeding with analysis of a sam- been added. Add 80 milliliters of isooctane to
ple, determine the absorbance in a 1-centi- the solution and extract by shaking the fun-
meter path cell between 250 mμ and 400 mμ nel vigorously for 2 minutes. Draw off the
for the reagent blank by carrying out the lower aqueous layer into a second separatory
procedure, without a wax sample, at room funnel (preferably 2-liter) and repeat the ex-
temperature, recording the spectrum after traction with 80 milliliters of isooctane.
the complete procedure as prescribed. The Draw off and discard the aqueous layer.
absorbance per centimeter pathlength fol- Wash each of the 80-milliliter extractives
lowing the complete procedure should not three times with 100-milliliter portions of
exceed 0.04 in the wavelength range from 280 distilled water. Shaking time for each wash
mμ to 299 mμ, inclusive, nor 0.02 in the wave- is 1 minute. Discard the aqueous layers. Fil-
length range from 300 mμ to 400 mμ. If in ei- ter the first extractive through anhydrous
ther spectrum the characteristic benzene sodium sulfate prewashed with isooctane (see
peaks in the 250 mμ-260 mμ region are Sodium sulfate under ‘‘Reagents and Mate-
present, remove the benzene by the proce- rials’’ for preparation of filter) into a 250-
dure under ‘‘Organic solvents’’ and record milliliter Erlenmeyer flask (or optionally
absorbance again. Place 300 milliliters of di- into the evaporation flask). Wash the first
methyl sulfoxide in a 1-liter separatory fun- separatory funnel with the second 80-milli-
nel and add 75 milliliters of phosphoric acid. liter isooctane extractive and pass through
Mix the contents of the funnel and allow to the sodium sulfate. Then wash the second
stand for 10 minutes. (The reaction between and first separatory funnels successively
the sulfoxide and the acid is exothermic. Re- with a 20-milliliter portion of isooctane and
lease pressure after mixing, then keep funnel pass the solvent through the sodium sulfate
stoppered.) Add 150 milliliters of isooctane into the flask. Add 1 milliliter of n-hexa-
and shake to preequilibrate the solvents. decane and evaporate the isooctane using an
Draw off the individual layers and store in aspirator vacuum under nitrogen and in an
glass-stoppered flasks. oil bath temperature of approximately 90 °C.
In a 1-liter separatory funnel place a rep- Discontinue evaporation when not over 1
resentative 25-gram sample of wax, add 50 milliliter of residue remains. To the residue,
milliliters of isooctane, heat gently, stir add a 10-milliliter portion of isooctane, re-
until the wax is in solution; add 100 milli- evaporate to 1 milliliter of hexadecane, and
liters of preequilibrated sulfoxide-phosphoric repeat this operation once.
acid mixture and shake, making sure it re- Reserve the residue for column chroma-
mains in solution. If the wax comes out of tography on the aluminum oxide. Fit the
solution during these operations, let the tetrafluoroethylene polymer disc on the
stoppered funnel remain in the jacket until upper part of the stem of the
438
chromatographic tube, then place the tube (b) The polyhydric alcohol esters
with the disc on the suction flask and apply identified in this paragraph may be
the vacuum (approximately 135 millimeters used as release agents in resinous and
Hg pressure). Weigh out 180 grams of the alu- polymeric coatings for polyolefin films
minum oxide and pour the adsorbent mixture
into the chromatographic tube in approxi-
complying with § 175.320 of this chapter.
mately 30-centimeter layers. After the addi- Such esters meet the following speci-
tion of each layer, level off the top of the ad- fications and are produced by partial
sorbent with a flat glass rod or metal plung- esterification of oxidatively refined
er by pressing down firmly until the adsorb- (Gersthofen process) montan wax acids
ent is well packed. Loosen the topmost few with equimolar proportions of ethylene
millimeters of each adsorbent layer with the glycol and 1,3-butanediol:
end of a metal rod before the addition of the (1) Dropping point 77°–82 °C, as deter-
next layer. Continue packing in this manner mined by ASTM method D566–76 (Re-
until all the 180 grams of the adsorbent is approved 1982), ‘‘Standard Test Method
added to the tube. Level off the top of the ad-
for Dropping Point of Lubricating
sorbent by pressing down firmly with a flat
glass rod or metal plunger to make the depth Grease,’’ which is incorporated by ref-
of the adsorbent bed approximately 80 centi- erence. The availability of this incor-
meters in depth. Turn off the vacuum and re- poration by reference is given in para-
move the suction flask. Dissolve the hexa- graph (a)(1) of this section.
decane residue in 10 milliliters of warm ben- (2) Acid value 25–35, as determined by
zene and decant the solution onto the col- ASTM method D1386–78 (‘‘Standard
umn and allow the liquid level to recede to Test Method for Acid Number (Empir-
barely above the adsorbent level. Rapidly ical) of Synthetic and Natural Waxes’’
complete the transfer similarly with two 10- (Revised 1978), which is incorporated by
milliliter portions of benzene swirling the
reference; copies are available from
flask repeatedly each time to assure ade-
quate washing of the residue. Fix the 1,000-
American Society for Testing and Ma-
milliliter reservoir onto the top of the terials (ASTM), 100 Barr Harbor Dr.,
chromatographic column. Just before the West Conshohocken, Philadelphia, PA
final 10-milliliter wash reaches the top of the 19428-2959, or available for inspection at
adsorbent, add 670 milliliters of benzene to the National Archives and Records Ad-
the reservoir and continue the percolation at ministration (NARA). For information
the 2–3 milliliter per minute rate until a on the availability of this material at
total of 670 milliliters of benzene has been NARA, call 202–741–6030, or go to: http://
utilized. Collect the eluate in a clean 1-liter www.archives.gov/federallregister/
Erlenmeyer flask (or optionally into a 1-liter
evaporation flask). Allow the column to
drain until most of the solvent mixture is re-
ibrllocations.html.) using as solvent xy-
moved. Add 1 milliliter of n-hexadecane and lene-ethyl alcohol in a 2:1 ratio instead
completely remove the benzene by evapo- of toluene-ethyl alcohol in a 1:2 ratio.
ration under nitrogen, using the special pro- (3) Saponification value 135–150, as
cedure to eliminate benzene as previously determined by ASTM method D1387–78
described under ‘‘Organic Solvents.’’ Quan- (‘‘Standard Test Method for Saponi-
titatively transfer the residue with isooctane fication Number (Empirical) of Syn-
to a 25-milliliter volumetric flask and adjust thetic and Natural Waxes’’ (Revised
to volume. Determine the absorbance of the 1978), which is incorporated by ref-
solution in the 1-centimeter pathlength cells
erence; copies are available from Amer-
compared to isooctane as reference between
250 mμ-400 mμ. Correct for any absorbance
ican Society for Testing and Materials
derived from the reagents as determined by (ASTM), 100 Barr Harbor Dr., West
carrying out the procedure without a wax Conshohocken, Philadelphia, PA 19428-
sample. If either spectrum shows the char- 2959, or available for inspection at the
acteristic benzene peaks in the 250 mμ-260 mμ National Archives and Records Admin-
region, evaporate the solution to remove istration (NARA). For information on
benzene by the procedure under ‘‘Organic the availability of this material at
Solvents.’’ Dissolve the residue, transfer NARA, call 202–741–6030, or go to: http://
quantitatively, and adjust to volume in iso-
www.archives.gov/federallregister/
octane in a 25-milliliter volumetric flask.
Record the absorbance again. If the cor-
ibrllocations.html.) using xylene-ethyl
rected absorbance does not exceed the limits

prescribed in paragraph (a) of this section, alcohol in a 2:1 ratio instead of ethyl
the wax meets the ultraviolet absorbance alcohol in preparation of potassium hy-
specifications. droxide solution.
439
§ 178.3780 21 CFR Ch. I (4–1–11 Edition)
(4) Ultraviolet absorbance limits reference in accordance with 5 U.S.C.

specified in paragraph (a)(4) of this sec- 552(a); the availability of this incorpo-
tion, as determined by the analytical ration by reference is given in para-
method described therein. graph (a)(2) of this section), using as a
(c) The polyhydric alcohol esters of solvent xylene-ethyl alcohol in a 2:1
oxidatively refined (Gersthofen proc- ratio instead of toluene-ethyl alcohol
ess) montan wax acids, identified in in a 2:1 ratio.
paragraph (a) or (b) of this section, (3) Saponification value 130–160, as
may also be used as a component of an determined by ASTM Method D–1387–78
aqueous dispersion of vinylidene chlo- ‘‘Standard Test Method for Saponifica-
ride copolymers, subject to the condi- tion Number (Empirical) of Synthetic
tions described in paragraphs (c) (1) and Natural Waxes’’ (Revised 1978),
and (2) of this section. (which is incorporated by reference in
(1) The aqueous dispersion of the ad- accordance with 5 U.S.C. 552(a); the
ditive contains not more that 18 per- availability of this incorporation by
cent polyhydric alcohol esters of reference is given in paragraph (a)(3) of
oxidatively refined (Gersthofen proc- this section), using xylene-ethyl alco-
ess) montan wax acids, not more than 2 hol in a 2:1 ratio instead of ethyl alco-
percent poly(oxyethylene) (minimum hol in the preparation of potassium hy-
20 moles of ethylene oxide) oleyl ether droxide solution.
(CAS Reg. No. 9004–98–2), and not more (4) Ultraviolet absorbance limits
than 1 percent poly(oxyethylene) (min- specified in paragraph (a)(4) of this sec-
imum 3 moles ethylene oxide) cetyl al- tion, as determined by the analytical
cohols (CAS Reg. No. 9004–95–9). method described therein.
(2) The aqueous dispersion described [42 FR 14609, Mar. 15, 1977, as amended at 47
in paragraph (c)(1) of this section is FR 11848, Mar. 19, 1982; 49 FR 10113, Mar. 19,
used as an additive to aqueous disper- 1984; 51 FR 33895, Sept. 24, 1986; 54 FR 24898,
sions of vinylidene chloride copoly- June 12, 1989; 55 FR 28020, July 9, 1990; 58 FR
mers, regulated in §§ 175.300, 175.320, 17512, Apr. 5, 1993; 69 FR 24512, May 4, 2004]
175.360, 176.170, 176,180, and 177.1630 of
this chapter, at levels not to exceed 1.5 § 178.3780 Polyhydric alcohol esters of
percent (solids basis) in the finished long chain monobasic acids.
coating. Polyhydric alcohol esters of long
(d) The polyhydric alcohol esters chain monobasic acids identified in
identified in this paragraph may be this section may be safely used as lu-
used as lubricants in the fabrication of bricants in the fabrication of polyvinyl
vinyl chloride plastic food contact arti- chloride and/or polyvinyl chloride co-
cles prepared from vinyl chloride poly- polymer articles complying with
mers. Such esters meet the following § 177.1980 of this chapter that contact
specifications and are produced by par- food of Types I, II, IV-B, VI-B, VII-B,
tial esterification of oxidatively re- and VIII identified in table 1 in
fined (Gersthofen process) montan wax § 176.170(c) of this chapter under condi-
acids with glycerol followed by neu- tions of use E, F, and G described in
tralization: table 2 in § 176.170(c) of this chapter,
(1) Dropping point 79 to 85 °C, as de- subject to the provisions of this sec-
termined by the American Society for tion.
Testing and Materials (ASTM), Method (a) Identity. For the purpose of this
D–566–76 (Reapproved 1982), ‘‘Standard section, polyhydric alcohol esters of
Test Method for Dropping Point of Lu- long chain monobasic acids consist of
bricating Grease,’’ which is incor- polyhydric alcohol esters having num-
porated by reference in accordance ber average molecular weights in the
with 5 U.S.C. 552(a). The availability of range of 1,050 to 1,700. The esters are
this incorporation by reference is given produced by the reaction of either
in paragraph (a)(1) of this section. ethylene glycol or glycerol with long
(2) Acid value 20–30, as determined by chain monobasic acids containing from
ASTM Method D–1386–78 ‘‘Standard 9 to 49 carbon atoms obtained by the
Test Method for Acid Number (Empir- ozonization of long chain alpha-olefins,
ical) of Synthetic and Natural Waxes’’ the unreacted carboxylic acids in the
(Revised 1978) (which is incorporated by formation of the glycerol esters being
440
neutralized with calcium hydroxide to reference. Copies are available from

produce a composition having up to 2 American Association of Oil Chemists,
percent by weight calcium. The alpha- 36 East Wacker Drive, Chicago, IL
olefins, obtained from the polymeriza- 60601, or available for inspection at the
tion of ethylene, have 20 to 50 carbon National Archives and Records Admin-
atoms and contain a minimum of 75 istration (NARA). For information on
percent by weight straight chain alpha- the availability of this material at
olefins and not more than 25 percent NARA, call 202–741–6030, or go to: http://
vinylidene compounds. www.archives.gov/federallregister/
(b) Specifications. The polyhydric al- codeloflfederallregulations/
cohol esters have the following speci- ibrllocations.html.
fications: (4) Ultraviolet absorbance as speci-
(1) Melting point of 60–80 °C for the fied in § 178.3770(a)(4) of this chapter
ethylene glycol ester and 90–105 °C for when tested by the analytical method
the glycerol ester as determined by the described therein.
Fisher Johns method as described in [42 FR 14609, Mar. 15, 1977, as amended at 47
‘‘Semimicro Qualitative Organic Anal- FR 11849, Mar. 19, 1982; 54 FR 24899, June 12,
ysis—The Systematic Identification of 1989; 61 FR 14481, Apr. 2, 1996]
Organic Compounds,’’ by Cheronis and
Entrikin, 2d Ed., Interscience Pub- § 178.3790 Polymer modifiers in
lishers, NY, which is incorporated by semirigid and rigid vinyl chloride
plastics.
reference. Copies are available from
the Center for Food Safety and Applied The polymers identified in paragraph
Nutrition (HFS–200), Food and Drug (a) of this section may be safely
Administration, 5100 Paint Branch admixed, alone or in mixture with
Pkwy., College Park, MD 20740, or other permitted polymers, as modifiers
available for inspection at the National in semirigid and rigid vinyl chloride
Archives and Records Administration plastic food-contact articles prepared
(NARA). For information on the avail- from vinyl chloride homopolymers and/
ability of this material at NARA, call or from vinyl chloride copolymers com-
202–741–6030, or go to: http:// plying with § 177.1950, § 177.1970, and/or
www.archives.gov/federallregister/ § 177.1980 of this chapter, in accordance
codeloflfederallregulations/ with the following prescribed condi-
ibrllocations.html. tions:
(2) Acid value 15–25 for each ester as (a) For the purpose of this section,
determined by the A.O.C.S. method the polymer modifiers are identified as
Trla-64T ‘‘Titer Test,’’ which is incor- follows:
porated by reference. Copies are avail- (1) Acrylic polymers identified in this
able from American Association of Oil subparagraph provided that such poly-
Chemists, 36 East Wacker Drive, Chi- mers contain at least 50 weight-percent
cago, IL 60601, or available for inspec- of polymer units derived from one or
tion at the National Archives and more of the monomers listed in para-
Records Administration (NARA). For graph (a)(1)(i) of this section.
information on the availability of this (i) Homopolymers and copolymers of
material at NARA, call 202–741–6030, or the following monomers:
go to: http://www.archives.gov/ n-Butyl acrylate.
federallregister/ n-Butyl methacrylate.
codeloflfederallregulations/ Ethyl acrylate.
ibrllocations.html. The method is modi- Methyl methacrylate.
fied to use as the acid solvent a 1:1 vol- (ii) Copolymers produced by co-
ume mixture of anhydrous isopropyl al- polymerizing one or more of the mono-
cohol and toluene. The solution is mers listed in paragraph (a)(1)(i) of this
titrated with 0.1N methanolic sodium section with one or more of the fol-
hydroxide. lowing monomers:
(3) Saponification value 120–160 for
Acrylonitrile.
the ethylene glycol ester and 90–130 for
Butadiene.
the glycerol ester as determined the a-Methylstyrene.
A.O.C.S. method Trla-64T ‘‘Saponifica- Styrene.
tion Value,’’ which is incorporated by Vinylidene chloride.
441
§ 178.3800 21 CFR Ch. I (4–1–11 Edition)
(iii) Polymers identified in para- than 30 weight-percent of polymer

graphs (a)(1) (i) and (ii) of this section units derived from copolymers of meth-
containing no more than 5 weight-per- yl methacrylate, a-methylstyrene and
cent of total polymer units derived by acrylonitrile and may optionally con-
copolymerization with one or more of tain up to 15 weight-percent of polymer
the following monomers: units derived from butadiene-styrene
Acrylic acid.
copolymers.
1,3-Butylene glycol dimethacrylate. (c) No chemical reactions, other than
Divinylbenzene. addition reactions, occur among the
Methacrylic acid. vinyl chloride polymers and the modi-
(iv) Mixtures of polymers identified fying polymers present in the polymer
in paragraph (a)(1) (i), (ii), and (iii) of mixture used in the manufacture of the
this section; provided that no chemical finished plastic food-contact article.
reactions, other than addition reac- (d) The finished plastic food-contact
tions, occur when they are mixed. article, when extracted with the sol-
(2) Polymers identified in paragraph vent or solvents characterizing the
(a)(1) of this section combined during type of food and under the conditions
their polymerization with butadiene- of time and temperature characterizing
styrene copolymers; provided that no the conditions of its intended use as de-
chemical reactions, other than addi- termined from tables 1 and 2 of
tion reactions, occur when they are § 176.170(c) of this chapter, yields ex-
combined. Such combined polymers tractives not to exceed the limits pre-
may contain 50 weight-percent or more scribed in § 177.1010 (b) (1), (2), (3), and
of total polymer units derived from the (4) of this chapter when tested by the
butadiene-styrene copolymers. methods prescribed in § 177.1010 (c) of
(b) The polymer content of the fin- this chapter.
ished plastic food-contact article con- (e) Acrylonitrile copolymers identi-
sists of: fied in this section shall comply with
(1) Not less than 80 weight-percent of the provisions of § 180.22 of this chap-
polymer units derived from the vinyl ter.
chloride polymers identified in the in-
§ 178.3800 Preservatives for wood.
troduction to this section and not more
than 5 weight-percent of polymer units Preservatives may be safely used on
derived from polymers identified in wooden articles that are used or in-
paragraph (a)(1) of this section and tended for use in packaging, trans-
may optionally contain up to 15 porting, or holding raw agricultural
weight-percent of polymer units de- products subject to the provisions of
rived from butadiene-styrene copoly- this section:
mers; or (a) The preservatives are prepared
(2) Not less than 50 weight-percent of from substances identified in para-
polymer units derived from the vinyl graph (b) of this section and applied in
chloride polymers identified in the in- amounts not to exceed those necessary
troduction to this section, not more to accomplish the technical effect of
than 50 weight-percent of polymer protecting the wood from decay, mil-
units derived from homopolymers and/ dew, and water absorption.
or copolymers of ethyl acrylate and (b) The substances permitted are as
methyl methacrylate, and not more follows:
Copper-8-quinolinolate.
Mineral spirits.
Paraffin wax ................................................................................. Used singly or in combination so as to constitute not less than
50% of the solids.
Petroleum hydrocarbon resin, produced by the homo- and co- Do.
polymerization of dienes and olefins of the aliphatic, alicyclic,
and monobenzenoid arylalkene type from distillates of
cracked petroleum stocks.

Pentachlorophenol and its sodium salt ....................................... Not to exceed 50 p.p.m. in the treated wood, calculated as
pentachlorophenol.
442
Rosins and rosin derivatives ....................................................... As provided in § 178.3870.

Zinc salt of sulfonated petroleum.
§ 178.3850 Reinforced wax. List of substances Limitations
Reinforced wax may be safely used as Copolymer of isobutylene modi-

an article or component of articles in- fied with isoprene.
Petroleum wax, Type I and Type
tended for use in producing, manufac- II.
turing, packing, processing, trans- Polyethylene.
porting, or holding food subject to the Rosins and rosin derivatives as
provided in § 178.3870.
provisions of this section. Synthetic wax polymer as de- Not to exceed 5 percent
(a) Reinforced wax consists of petro- scribed in § 176.170(a)(5) of by weight of the petro-
leum wax to which have been added this chapter. leum wax.
certain optional substances required in
its production, or added to impart de- (e) Reinforced wax conforming with
sired physical or technical properties. the specifications in this paragraph is
(b) The quantity of any optional ad- used as provided in paragraph (e)(2) of
juvant substance employed in the pro- this section.
duction of or added to reinforced wax (1) The chloroform-soluble portion of
does not exceed the amount reasonably the water extract obtained by exposing
required to accomplish the intended reinforced wax to demineralized water
physical or technical effect or any lim- at 70 °F for 48 hours shall not exceed 0.5
itation provided in this section. milligram per square inch of food-con-
(c) Any substance employed in the tact surface.
production of reinforced wax, including (2) It is used as a packaging material
any optional substance, that is the sub- or component of packaging materials
ject of a regulation in parts 174, 175, for cheese and cheese products.
176, 177, 178 and § 179.45 of this chapter, [42 FR 14609, Mar. 15, 1977, as amended at 47
conforms with any specification in FR 1288, Jan. 12, 1982]
such regulation.
(d) The substances and optional adju- § 178.3860 Release agents.
vant substances employed in the pro- Substances listed in paragraph (b) of
duction of or added to reinforced wax this section may be safely used as re-
include: lease agents in petroleum wax com-
(1) Substances generally recognized plying with § 178.3710 and in polymeric
as safe in food. resins that contact food, subject to the
(2) Substances subject to prior sanc- provisions of this section.
tion for use in reinforced wax and used (a) The quantity used shall not ex-
in accordance with such sanction or ap- ceed the amount reasonably required
proval. to accomplish the intended technical
(3) Substances identified in this sub- effect or any limitations prescribed in
paragraph and subject to any limita- this section.
tions provided therein: (b) Release agents:
Erucamide (erucylamide).
Formaldehyde, polymer with 1-naphthalenol (CAS For use only as an antiscaling or release agent, applied on the internal
Reg. No. 25359–91–5). parts of reactors employed in the production of polyvinyl chloride and
acrylic copolymers, provided that the residual levels of the additive in the
ploymer do not exceed 4 parts per million.
N,N′-Dioleoylethylenediamine ................................. For use only in polyvinyl chloride films in amounts such that the concentra-
tion of the substance in these films in the form in which the films contact
food shall not exceed 0.055 milligram of the substance per square inch of
film.
Oleyl palmitamide.
Polybutene, hydrogenated; complying with the For use only subject to the limitations prescribed for hydrogenated
identity prescribed under § 178.3740(b). polybutene under § 178.3740(b).
443
§ 178.3870 21 CFR Ch. I (4–1–11 Edition)
Poly(vinyl acetate/vinyl N-octadecylcarbamate) For use only in application to the backing of pressuresensitive adhesive
(CAS Reg. No. 70892–21–6) produced by the tapes at levels not to exceed 0.2 milligram per square centimeter (1.29
reaction between stoichiometrically equivalent milligrams per square inch) of backing.
amounts of octadecyl isocyanate and vinyl alco-
hol/vinyl acetate copolymer; minimum average
molecular weight is 500,000.
Rice bran wax ......................................................... For use only in plastics intended for contact with dry foods identified as
Type VIII in table 1 of § 176.170(c) of this chapter, at levels not in excess
of 1.0 percent by weight of the polymer.
Saturated fatty acid amides manufactured from
fatty acids derived from animal, marine, or vege-
table fats and oils.
Stearyl erucamide.
[42 FR 14609, Mar. 15, 1977, as amended at 44 FR 69649, Dec. 4, 1979; 46 FR 51902, Oct. 23, 1981;
61 FR 25396, May 21, 1996; 61 FR 42381, Aug. 15, 1996]
§ 178.3870 Rosins and rosin deriva- cent, a minimum drop-softening point

tives. of 79 °C, and a color of X or paler.
The rosins and rosin derivatives iden- (iii) Partially dimerized rosin,
tified in paragraph (a) of this section dimerized by sulfuric acid catalyst to a
may safely be used in the manufacture drop-softening point of 95°–105 °C and a
of articles or components of articles in- color of WG or paler.
tended for use in producing, manufac- (iv) Fully dimerized rosin, dimerized
turing, packing, processing, preparing, by sulfuric acid catalyst, and from
treating, packaging, transporting, or which sufficient nondimerized rosin
holding food, subject to the provisions has been removed by distillation to
of this section. achieve a minimum drop-softening
(a) The rosins and rosin derivatives point of 143 °C, and a color of H or
are identified as follows: paler.
(1) Rosins: (v) Disproportionated rosin, catalyt-
(i) Gum rosin, refined to color grade ically disproportionated to a minimum
of K or paler. dehydroabietic acid content of 35 per-
(ii) Wood rosin, refined to color grade cent, a maximum abietic acid content
of K or paler. of 1 percent, a maximum content of
(iii) Tall oil rosin, refined to color substituted phenanthrenes (as retene)
grade of K or paler. of 0.25 percent, and a color of WG or
(iv) Dark tall oil rosin, a fraction re- paler.
sulting from the refining of tall oil (3) Rosin esters manufactured from
rosin produced by multicolumnar dis- rosins and modified rosins identified in
tillation of crude tall oil to effect re- paragraphs (a)(1) and (2) of this section:
moval of fatty acids and pitch compo-
(i) Glycerol ester of wood rosin puri-
nents and having a saponification num-
fied by steam stripping to have an acid
ber of from 110–135 and 32 percent–44
number of 3 to 9, a drop-softening point
percent rosin acids.
(v) Dark wood rosin, all or part of the of 88°–96 °C, and a color of N or paler.
residue after the volatile terpene oils (ii) Glycerol ester of partially hydro-
are distilled from the oleoresin ex- genated wood rosin, having an acid
tracted from pine wood. number of 3 to 10, a drop-softening
(2) Modified rosins manufactured point of 79°–88 °C, and a color of N or
from rosins identified in paragraph paler.
(a)(1) of this section: (iii) Glycerol ester of partially
(i) Partially hydrogenated rosin, cat- dimerized rosin, having an acid number
alytically hydrogenated to a maximum of 3 to 8, a drop-softening point of 109°–
refractive index of 1.5012 at 100 °C, and 119 °C, and a color of M or paler.
a color of WG or paler. (iv) Glycerol ester of fully dimerized
(ii) Fully hydrogenated rosin, cata- rosin, having an acid number of 5 to 16,
lytically hydrogenated to a maximum a drop-softening point of 165°–175 °C,
dehydroabietic acid content of 2 per- and a color of H or paler.
444
(v) Glycerol ester of maleic anhy- (xiv) Mixed methyl and pentaeryth-
dride-modified wood rosin, having an ritol ester of maleic anhydride-modi-
acid number of 30 to 40, a drop-soft- fied wood rosin, having an acid number
ening point of 138°–146 °C, a color of M of 73 to 83, a drop-softening point of
or paler, and a saponification number 113°–123 °C, a color of M or paler, and a
less than 280. saponification number less than 280.
(vi) Methyl ester of rosin, partially (xv) Triethylene glycol ester of par-
hydrogenated, purified by steam strip- tially hydrogenated wood rosin, having
ping to have an acid number of 4 to 8, an acid number of 2 to 10, a color of K
a refractive index of 1.5170 to 1.5205 at or paler, and a viscosity of 350 to 425
20 °C, and a viscosity of 23 to 66 poises seconds Saybolt at 100 °C.
at 25 °C. (xvi) Glycerol ester of maleic anhy-
(vii) Pentaerythritol ester of wood dride-modified wood rosin, having an
rosin, having an acid number of 6 to 16, acid number of 17 to 23, a drop-soft-
a drop-softening point of 109°–116 °C, ening point of 136°–140 °C, a color of M
and a color of M or paler. or paler, and a saponification number
(viii) Pentaerythritol ester of par- less than 280. For use only in cello-
tially hydrogenated wood rosin, having phane complying with § 177.1200 of this
an acid number of 7 to 18, a drop-soft- chapter.
ening point of 102°–110 °C, and a color of (xvii) Citric acid-modified glycerol
K or paler. ester of rosin, having an acid number
(ix) Pentaerythritol ester of maleic less than 20, a drop-softening point of
anhydride-modified wood rosin, having 105°–115 °C, and a color of K or paler.
an acid number of 8 to 16, a drop-soft- For use only as a blending agent in
ening point of 154°–162 °C, a color of M coatings for cellophane complying with
or paler, and having a saponification § 177.1200 of this chapter.
number less than 280. (xviii) Glycerol ester of tall oil rosin,
(x) Pentaerythritol ester of maleic purified by steam stripping to have an
anhydride-modified wood rosin, having acid number of 5–12, a softening point
an acid number of 9 to 16, a drop-soft- of 80°–88 °C, and a color of N or paler.
ening point of 130°–140 °C, a color of N (xix) Glycerol ester of maleic anhy-
or paler, and having a saponification dride-modified tall oil rosin, having an
number less than 280. acid number of 30 to 40, a drop-soft-
(xi) Pentaerythritol ester of maleic ening point of 141°–146 °C, a color of N
anhydride-modified wood rosin, having or paler, and a saponification number
an acid number of 134 to 145, a drop- less than 280.
softening point of 127°–137 °C, a color of (xx) Glycerol ester of
M or paler, and having a saponification disproportionated tall oil rosin, having
number less than 280. an acid number of 5 to 10, a drop-soft-
(xii) Pentaerythritol ester of maleic ening point of 84°–93 °C, a color of WG
anhydride-modified wood rosin, having or paler, and a saponification number
an acid number of 30 to 40, a drop-soft- less than 180.
ening point of 131°–137 °C, a color of N (4) Rosin salts and sizes—Ammo-
or paler, and having a saponification nium, calcium, potassium, sodium, or
number less than 280. zinc salts of rosin manufactured by the
(xiii) Pentaerythritol ester of maleic partial or complete saponification of
anhydride-modified wood rosin, further any one of the rosins or modified rosins
modified by reaction with 4,4′-iso- identified in paragraph (a)(1) and (2) of
propyl-idenediphenol-formaldehyde this section, or blends thereof, and
condensate, having an acid number of with or without modification by reac-
10 to 22, a drop-softening point of 162°– tion with one or more of the following:
172 °C, a color of K or paler, a saponi- (i) Formaldehyde.
fication number less than 280, and a (ii) Fumaric acid.
maximum ultraviolet absorbance of (iii) Maleic anhydride.
0.14 at 296 mμ (using a 1-centimeter cell (iv) Saligenin.
and 200 milligrams of the rosin ester (b) The quantity used shall not ex-
per liter of solvent consisting of ethyl ceed the amount reasonably required
alcohol made alkaline by addition of to accomplish the intended technical
0.1 percent of potassium hydroxide). effect.
445
§ 178.3870 21 CFR Ch. I (4–1–11 Edition)
(c) The use in any substance or arti- (4) Viscosity: Viscosity in poises
cle that is the subject of a regulation shall be as determined by ASTM meth-
in parts 174, 175, 176, 177, 178 and § 179.45 od D1824–66 (Reapproved 1980), ‘‘Stand-
of this chapter shall conform with any ard Test Method for Apparent Vis-
specifications and limitations pre- cosity of Plastisols and Organosols at
scribed by such regulation for the fin- Low Shear Rates by Brookfield Vis-
ished form of the substance or article. cometer,’’ and in Saybolt seconds by
(d) The provisions of this section are ASTM method D88–81, ‘‘Standard Test
not applicable to rosins and rosin de- Method for Saybolt Viscosity,’’ which
rivatives identified in § 175.300(b)(3)(v) are incorporated by reference. The
of this chapter and used in resinous availability of this incorporation by
and polymeric coatings complying with reference is given in paragraph (f)(1) of
§ 175.300 of this chapter. this section.
(e) The provisions of this section are (5) Softening point: Softening point
not applicable to rosins and rosin de- shall be as determined by ASTM meth-
rivatives identified in § 175.105(c)(5) of od E28–67, ‘‘Standard Test Method for
this chapter and used in defoaming Softening Point by Ring and Ball Ap-
agents complying with § 176.210 of this
paratus’’ (Reapproved 1977), which is
chapter, food-packaging adhesives
incorporated by reference. Copies are
complying with § 175.105 of this chapter,
available from American Society for
and rubber articles complying with
Testing and Materials (ASTM), 100
Barr Harbor Dr., West Conshohocken,
(f) The analytical methods for deter-
Philadelphia, PA 19428-2959, or avail-
mining whether rosins and rosin de-
rivatives conform to the specifications able for inspection at the National Ar-
prescribed in paragraph (a) of this sec- chives and Records Administration
tion are as follows: (NARA). For information on the avail-
(1) Color: Color shall be as deter- ability of this material at NARA, call
mined by ASTM method D509–70 (Re- 202–741–6030, or go to: http://
approved 1981), ‘‘Standard Methods of www.archives.gov/federallregister/
Sampling and Grading Rosin,’’ which is codeloflfederallregulations/
incorporated by reference. Copies may ibrllocations.html.
be obtained from the American Society (6) Analytical methods for deter-
for Testing Materials, 100 Barr Harbor mining drop-softening point, saponi-
Dr., West Conshohocken, Philadelphia, fication number, and any other speci-
PA 19428-2959, or may be examined at fications not listed under paragraphs
the National Archives and Records Ad- (f)(1) through (5) of this section, titled:
ministration (NARA). For information (i) ‘‘Determination of Abeitic Acid and
on the availability of this material at Dehydroabietic Acid in Rosins’’; (ii)
NARA, call 202–741–6030, or go to: http:// ‘‘Determination of Softening Point of
www.archives.gov/federallregister/ Solid Resins’’; (iii) ‘‘Determination of
codeloflfederallregulations/ Saponification Number of Rosin
ibrllocations.html. Esters,’’ and (iv) ‘‘Determination of
(2) Refractive index: Refractive index Phenolic Modification of Rosin Deriva-
shall be as determined by ASTM meth- tives,’’ which are incorporated by ref-
od D1747–62 (Reapproved 1978), ‘‘Stand- erence. Copies are available from the
ard Test Method for Refractive Index of Center for Food Safety and Applied Nu-
Viscous Materials,’’ which is incor- trition (HFS–200), Food and Drug Ad-
porated by reference. The availability ministration, 5100 Paint Branch Pkwy.,
of this incorporation by reference is College Park, MD 20740, or available for
given in paragraph (f)(1) of this section. inspection at the National Archives
(3) Acid number: Acid number shall and Records Administration (NARA).
be as determined by ASTM method For information on the availability of
D465–82, ‘‘Standard Test Methods for this material at NARA, call 202–741–
Acid Number of Rosin,’’ which is incor-
6030, or go to: http://www.archives.gov/

porated by reference. The availability
federallregister/
of this incorporation by reference is
given in paragraph (f)(1) of this section.
446
codeloflfederallregulations/ § 178.3910 Surface lubricants used in

ibrllocations.html. the manufacture of metallic arti-
cles.
FR 11849, Mar. 19, 1982; 49 FR 10113, Mar. 19, The substances listed in this section
1984; 54 FR 24899, June 12, 1989] may be safely used in surface lubri-
cants employed in the manufacture of
§ 178.3900 Sodium metallic articles that contact food,
pentachlorophenate. subject to the provisions of this sec-
tion.
Sodium pentachlorophenate may be
(a) The following substances may be
safely used as a preservative for ammo-
used in surface lubricants used in the
nium alginate employed as a proc-
rolling of metallic foil or sheet stock
essing aid in the manufacture of poly- provided that total residual lubricant
vinyl chloride emulsion polymers in- remaining on the metallic article in
tended for use as articles or compo- the form in which it contacts food does
nents of articles that contact food at not exceed 0.015 milligram per square
temperatures not to exceed room tem- inch of metallic food-contact surface:
perature. The quantity of sodium (1) Substances identified in para-
pentachlorophenate used shall not ex- graphs (b)(1) and (2) of this section.
ceed 0.5 percent by weight of ammo- (2) Substances identified in this para-
nium alginate solids. graph.
a-Butyl-W-–hydroxypoly (oxyethylene)-poly (oxypropylene)

(CAS Reg. No. 9038–95–3) produced by random condensa-
tion of a 1:1 mixture by weight of ethylene oxide and pro-
pylene oxide with butanol and having a minimum molecular
weight of 1,000.
a–Butyl–W–hydroxypoly(oxypropylene) (CAS Reg. No. 9003-
13–8) having a minimum molecular weight of 1000.
a–Lauroyl–W–hydroxpoly(oxyethylene) (CAS Reg. No. 9004–
81–3) having a minimum molecular weight of 200.
Acetate esters derived from synthetic straight chain alcohols
(complying with § 172.864 of this chapter) that have even
numbers of carbon atoms in the range C8-C18.
alpha-Alkyl–omega-hydroxypoly(oxyethylene) produced by the
condensation of 1 mole of C12-C15 straight chain primary al-
cohols with an average of 3 moles of ethylene oxide (CAS
Reg. No. 68002–97–1).
Benzotriazole (CAS Reg. No. 95–14–7).
Bis(hydrogenated tallow alkyl)amine (CAS Reg. No. 61789– Not to be used in combination with sodium nitrite.
79–5).
Bis(hydrogenated tallow alkyl)aminoethanol (CAS Reg. No.
116438–56–3).
N,N-Bis(2-hydroxyethyl)butylamine (CAS Reg. No. 102–79–4).
Tert-Butyl alcohol.
Di(2-ethylhexyl)phthalate.
Diethyl phthalate.
Diethylene glycol monobutylether (CAS Reg. No. 112–34–5).
Dimers, trimers, and/or their partial methyl esters; such dimers For use only at a level not to exceed 10 percent by weight of
and trimers are of unsaturated C18 fatty acids derived from finished lubricant formulation.
animal and vegetable fats and oils and/or tall oil, and such
partial methyl esters meet the following specifications: Sa-
ponification value 180–200, acid value 70–130, and max-
imum iodine value 120.
Di-n-octyl sebacate.
Ethylenediaminetetraacetic acid, sodium salts.
Isopropyl alcohol.
Isopropyl laurate (CAS Reg. No. 10233–13–3) .......................... For use at a level not to exceed 10 percent by weight of the
finished lubricant formulation.
Isopropyl oleate.
Isotridecyl alcohol, ethoxylated (CAS Reg. No. 9043–30–5).
Methyl esters of coconut oil fatty acids.
Methyl esters of fatty acids (C16-C18) derived from animal and
vegetable fats and oils.
Polybutene, hydrogenated: complying with the identity pre-

scribed under § 178.3740(b).
Polyethylene glycol (400) monostearate.
Polyisobutylene (minimum molecular weight 300).
447
§ 178.3910 21 CFR Ch. I (4–1–11 Edition)
Polyoxyethylated (5 moles) tallow amine (CAS Reg. No.

61791–26–2).
Polyvinyl alcohol.
Sodium nitrite ............................................................................... For use only as a rust inhibitor in lubricant formulations pro-
vided the total residual sodium nitrite on the metallic article
in the form in which it contacts food does not exceed 0.007
milligram per square inch of metallic food-contact surface.
Sodium petroleum sulfonate, MW 440–450 (CAS Reg. No.
68608–26–4) derived from naphthenic oil having a Saybolt
viscosity range of 500–600 Saybolt Universal Seconds (SUS
at 37–8 °C (100 °F) as determined by ASTM method D88–
81, ‘‘Standard Test Method for Saybolt Viscosity,’’ which is
incorporated by reference. Copies are available from the
American Society for Testing Materials, 1961 Race St.,
Philadelphia, PA 19103, or available for inspection at the Na-
tional Archives and Records Administration (NARA). For in-
formation on the availability of this material at NARA, call
202–741–6030, or go to: http://www.archives.gov/
federallregister/codeloflfederallregulations/
Synthetic alcohol mixture of straight-and branched-chain alco-
hols that have even numbers of carbon atoms in the range
C4C18 and that are prepared from ethylene, aluminum, and
hydrogen such that the finished synthetic alcohol mixture
contains not less than 75 pct of straight-chain primary alco-
hols and contains not less than 85 pct total C10 and C12 al-
cohols.
Synthetic primary alcohol mixture of straight- and branched- For use at a level not to exceed 8 pct by weight of the finished
chain alcohols that contain at least 99 pct primary alcohols lubricant formulation.
consisting of the following: not less than 70 pct normal alco-
hols; not less than 96.5 pct C12-C15 alcohols; and not more
than 2.5 pct alpha, omega C13-C16 diols. The alcohols are
prepared from linear olefins from a purified kerosene frac-
tion, carbon monoxide and hydrogen using a modified oxo
process, such that the finished primary alcohol mixture
meets the following specifications: Molecular weight, 207±4;
hydroxyl number, 266–276.
Synthetic primary alcohol mixture of straight- and branched- For use only at a level not to exceed 8 pct by weight of the fin-
chain alcohols that contain at least 99 pct primary alcohols ished lubricant formulation.
consisting of the following: not less than 70 percent normal
alcohols; not less than 93 pct C12-C13 alcohols; not more
than 5 pct C14-C15 alcohols; and not more than 2.5 pct
alpha, omega, C13-C16 diols. The alcohols are prepared from
linear olefins from a purified kerosene fraction, carbon mon-
oxide and hydrogen using a modified oxo process, such that
the finished primary alcohol mixture meets the following
specifications:
Molecular weight 194±5; hydroxyl number, 283–296.
Tallow, sulfonated.
Triethanolamine.
(3) Mineral oil conforming to the affinic, isoparaffinic, napthenic, or aro-

identity prescribed in § 178.3620(c). matic in nature, and meet the fol-
(4) Light petroleum hydrocarbons lowing specifications:
identified in paragraph (a)(4) (i) of this (a) Initial boiling point is 24 °C min-
section: Provided, That the total resid- imum and final boiling point is 288 °C
ual lubricant on the metallic article in maximum, as determined by ASTM
the form in which it contacts food method D86–82, ‘‘Standard Method for
meets the ultraviolet absorbance lim- Distillation of Petroleum Products,’’
its prescribed in paragraph (a) (4) (ii) of which is incorporated by reference.
this section as determined by the ana- Copies may be obtained from the Amer-
lytical method described in paragraph ican Society for Testing Materials, 100
(a) (4) (iii) of this section. Barr Harbor Dr., West Conshohocken,
(i) Light petroleum hydrocarbons are Philadelphia, PA 19428-2959, or may be
derived by distillation from virgin pe- examined at the National Archives and
troleum stocks or are synthesized from Records Administration (NARA). For
petroleum gases. They are chiefly par- information on the availability of this
448
material at NARA, call 202–741–6030, or under ultraviolet light to detect any residual
go to: http://www.archives.gov/ fluorescent contamination. As a pre-
federallregister/ cautionary measure it is recommended prac-
tice to rinse all glassware with purified iso-
codeloflfederallregulations/ octane immediately before use. No grease is
ibrllocations.html. to be used on stopcocks or joints. Great care
(b) Nonvolatile residue is 0.005 gram to avoid contamination of oil samples in
per 100 milliliters, maximum, as deter- handling and to assure absence of any extra-
mined by ASTM method D381–80, neous material arising from inadequate
‘‘Standard Test Method for Existent packaging is essential. Because some of the
Gum in Fuels by Jet Evaporation,’’ polynuclear hydrocarbons sought in this test
when the final boiling point is 121 °C or are very susceptible to photo-oxidation, the
above and by ASTM method D1353–78, entire procedure is to be carried out under
subdued light.
‘‘Standard Test Method for Nonvolatile
Matter in Volatile Solvents for Use in APPARATUS
Paint, Varnish, Lacquer, and Related Separatory funnels. 250-milliliter, 500-milli-
Products,’’ when the final boiling point liter, 1,000-milliliter, and preferably 2,000-
is below 121 °C. These ASTM methods milliliter capacity, equipped with tetra-
are incorporated by reference. The fluoroethylene polymer stopcocks.
availability of these incorporations by Evaporation flask (optional). 250-milliliter or
reference is given in paragraph 500-milliliter capacity all-glass flask
(a)(4)(i)(a) of this section. equipped with standard-taper stopper having
(c) Saybolt color 20 minimum as de- inlet and outlet tubes to permit passage of
nitrogen across the surface of contained liq-
termined by ASTM method D156–82,
uid to be evaporated.
‘‘Standard Test Method for Saybolt Spectrophotometric cells. Fused quartz cells,
Color of Petroleum Products (Saybolt optical path length in the range of 5,000 cen-
Chromometer Method),’’ which is in- timeters ±0.005 centimeter; also for checking
corporated by reference. The avail- spectrophotometer performance only, optical
ability of this incorporation by ref- path length in the range 1.000 centimeter
erence is given in paragraph (a)(4)(i)(a) ±0.005 centimeter. With distilled water in the
of this section. cells, determine any absorbance differences.
Spectrophotometer. Special range 250
(d) Aromatic component content
millicrons-400 millimicrons with spectral slit
shall not exceed 32 percent. width of 2 millimicrons or less; under instru-
(e) Conforms with ultraviolet absorb- ment operating conditions for these absorb-
ance limits prescribed in § 178.3620(c) as ance measurements, the spectrophotometer
determined by the analytical method shall also meet the following performance
described therein. requirements:
(ii) Ultraviolet absorbance limits on Absorbance repeatability, ±0.01 at 0.4 ab-
residual lubricants are as follows: sorbance.
Absorbance accuracy, 1 ±0.05 at 0.4 absorb-
Maximum ance.
absorb- Wavelength repeatability, ±0.2 milli-
ance per 5
Wavelength (mμ) centi- micron.
meters op- Wavelength accuracy, ±1.0 millimicron.
tical
pathlength
1 As determined by procedure using potas-
280–289 ............................................................... 0.7 sium chromate for reference standard and
290–299 ............................................................... .6 described in National Bureau of Standards
300–359 ............................................................... .4
360–400 ............................................................... .09
Circular 484, Spectrometry, U.S. Department
of Commerce (1949), which is incorporated by
reference. Copies are available from the Cen-
(iii) The analytical method for deter- ter for Food Safety and Applied Nutrition
mining ultraviolet absorbance limits (HFS–200), Food and Drug Administration,
on residual lubricants is as follows: 5100 Paint Branch Pkwy., College Park, MD
20740, or available for inspection at the Na-
GENERAL INSTRUCTIONS
tional Archives and Records Administration
Because of the sensitivity of the test, the (NARA). For information on the availability
possibility of errors arising from contamina- of this material at NARA, call 202–741–6030,
tion is great. It is of the greatest importance or go to: http://www.archives.gov/
that all glassware be scrupulously cleaned to federallregister/codeloflfederallregulations/

remove all organic matter such as oil, ibrllocations.html. The accuracy is to be de-
grease, detergent, residues, etc. Examine all termined by comparison with the standard
glassware including stoppers and stopcocks, values at 210, 345, and 400 millimicrons.
449
§ 178.3910 21 CFR Ch. I (4–1–11 Edition)
Soxhlet apparatus. 60-millimeter diameter Absorb-
body tubes fitted with condenser and 500-mil- Wavelength ance (max-
liliter round-bottom boiling flask. A supply imum)
of paper thimbles to fit is required. 280 ....................................................................... .06
Nitrogen cylinder. Water-pumped or equiva- 300 ....................................................................... .015
lent purity nitrogen in cylinder equipped
with regulator and valve to control flow at 5 There shall be no irregularities in the ab-
p.s.i.g. sorbance curve within these wavelengths.
Phosphoric acid. 85 percent A.C.S. reagent
REAGENTS AND MATERIALS
grade.
Organic solvents. All solvents used through- Sodium sulfate, anhydrous, A.C.S. reagent
out the procedure shall meet the specifica- grade, preferably in granular form. For each
tions and tests described in this specifica- bottle of sodium sulfate reagent used, estab-
tion. The isooctane (2,2,4-trimethylpentane) lish as follows the necessary sodium sulfate
shall pass the following test: prewash to provide such filters required in
Place 180 milliliters of solvent in a 250-mil- the method: Place approximately 35 grams of
liliter Erlenmeyer flask, add 1 milliliter of anhydrous sodium sulfate in a 30-milliliter
purified n-hexadecane and evaporate on the coarse, fritted-glass funnel or in a 65-milli-
steam bath under a stream of nitrogen (a liter filter funnel with glass wool plug; wash
loose aluminum foil jacket around the flask with successive 15-milliliter portions of the
will speed evaporation). Discontinue evapo- indicated solvent until a 15-milliliter portion
ration when not over 1 milliliter of residue of the wash shows 0.00 absorbance per centi-
remains. meter path length between 280 mμ and 400 mμ
Alternatively, the evaporation time can be when tested as prescribed under ‘‘Organic
reduced by using the optional evaporation solvents.’’ Usually three portions of wash
flask. In this case the solvent and n-hexa- solvent are sufficient.
decane are placed in the flask on the steam Before proceeding with analysis of a sam-
bath, the tube assembly is inserted, and a ple, determine the absorbance in a 5-centi-
stream of nitrogen is fed through the inlet meter path cell between 250 millimicrons and
tube while the outlet tube is connected to a 400 millimicrons for the reagent blank by
solvent trap and vacuum line in such a way carrying out the procedure, without a metal
as to prevent any flow-back of condensate sample. The absorbance per centimeter path
into the flask. length should not exceed 0.02 in the wave-
Dissolve the 1 milliliter of hexadecane res- length range from 280 mμ to 400 mμ.
idue in isooctane and make to 25 milliliters Place 300 milliliters of dimethyl sulfoxide
volume. Determine the absorbance in the 5- in a 1-liter separatory funnel and add 75 mil-
centimeter path length cells compared to liliters of phosphoric acid. Mix the contents
isooctane as reference. The absorbance of the of the funnel and allow to stand for 10 min-
solution of the solvent residue shall not ex- utes. (The reaction between the sulfoxide
ceed 0.01 per centimeter path length between and the acid is exothermic. Release pressure
280 and 400 mμ. Purify, if necessary, by pas- after mixing, then keep funnel stoppered.)
sage through a column of activated silica gel Add 150 milliliters of isooctane and shake to
(Grade 12, Davison Chemical Co., Baltimore, pre-equilibrate the solvents. Draw off the in-
Maryland, or equivalent) about 90 centi- dividual layers and store in glass-stoppered
meters in length and 5 centimeters to 8 cen- flasks.
timeters in diameter.
n-Hexadecane, 99-percent olefin-free. Dilute PROCEDURE
1.0 milliliter of n-hexadecane to 25 milliliters
Sample. Select metal foil or sheet stock for
with isooctane and determine the absorbance
the test which has not been previously con-
in a 5-centimeter cell compared to isooctane
taminated by careless handling or exposure
as reference point between 280 mμ-400 mμ.
to atmospheric dust and fumes. A commer-
The absorbance per centimeter path length
cial coil in the form supplied for spindle
shall not exceed 0.00 in this range. Purify, if
mounting in a packaging line or wrapping
necessary, by percolation through activated
machine is most suitable. Strip off the out-
silica gel or by distillation.
Dimethyl sulfoxide. Spectrophotometric side turn of metal and discard. Carefully
grade (Crown Zellerbach Corp., Camas, avoid contamination or damage from han-
Washington, or equivalent). Absorbance (1- dling the metal (wear gloves). Remove a 16–
centimeter cell, distilled water reference, 18-foot length from the coil and place it on a
sample completely saturated with nitrogen). flat surface protected by a length of new
kraft paper. Cut four 15-foot strips from the
Absorb- sample, each 3 inches wide (avoid tearing the
Wavelength ance (max- edges of the strips). Using a piece of suitable
imum)
glass rod, roll the strips of metal into loose

261.5 .................................................................... 1.00 coils and insert each into a Soxhlet thimble.
270 ....................................................................... .20 Each turn of coil should be visibly separated
275 ....................................................................... .09 from the adjacent turn.
450
Extraction. Fill each of the four Soxhlet tractive through anhydrous sodium sulfate
tubes with purified isooctane (see under pre-washed with isooctane (see sodium sul-
heading ‘‘Reagents and Materials,’’ above) fate under ‘‘Reagents and Materials’’ for
until siphon action occurs and then refill the preparation of filter) into a 250-milliliter Er-
tube body. Supply heat to the boiling flask lenmeyer flask (or optionally into the evapo-
and allow extraction to continue for at least ration flask). Wash the first separatory fun-
8 hours or until repeated weighings of the nel with the second 80-milliliter isooctane
dried and cooled coil show no further weight extractive and pass through the sodium sul-
loss. fate. Then wash the second and first sepa-
Combine the isooctane extracts from the ratory funnels successively with a 20-milli-
four Soxhlet units in a suitable beaker, rins- liter portion of isooctane and pass the sol-
ing each tube and flask into the beaker with vent through the sodium sulfate into the
fresh purified solvent. Evaporate the solvent
flask. Add 1 milliliter of n-hexadecane and
under an atmosphere of inert gas (nitrogen)
evaporate the isooctane on the steam bath
to residual volume of 50–60 milliliters and
under nitrogen. Discontinue evaporation
transfer this solution to a 500-milliliter sepa-
when not over 1 milliliter of residue remains.
ratory funnel containing 100 milliliters of
To the residue, add a 10-milliliter portion of
pre-equilibrated sulfoxide-phosphoric acid
mixture. Complete the transfer of the sample isooctane, reevaporate to 1 milliliter of
with small portions of pre-equilibrated iso- hexadecane, and repeat this operation once.
octane to give a total volume of the residue Quantitatively transfer the residue with
and solvent of 75 milliliters. Shake the fun- isooctane to a 25-milliliter volumetric flask,
nel vigorously for 2 minutes. Set up three make to volume, and mix. Determine the ab-
250-milliliter separatory funnels with each sorbance of the solution in 5-centimeter
containing 30 milliliters of pre-equilibrated pathlength cells compared to isooctane as
isooctane. After separation of liquid phases, reference between 280mμ–400mμ (take care to
carefully draw off lower layer into the first lose none of the solution in filling the sam-
250-milliliter separatory funnel and wash in ple cell). Correct the absorbance values for
tandem with the 30-milliliter portion of iso- any absorbance derived from reagents as de-
octane contained in the 250-milliliter sepa- termined by carrying out the procedure
ratory funnels. Shaking time for each wash without a metal sample. If the corrected ab-
is 1 minute. Repeat the extraction operation sorbance does not exceed the limits pre-
with two additional portions of the sulf- scribed in this paragraph, the residue meets
oxide-acid mixture and wash each extractive the ultraviolet absorbance specifications.
in tandem through the same three portions
of isooctane. (b) The following substances may be
Collect the successive extractives (300 mil- used in surface lubricants used to fa-
liliters total) in a separatory funnel (pref- cilitate the drawing, stamping, or
erably 2-liter) containing 480 milliliters of forming of metallic articles from rolled
distilled water; mix, and allow to cool for a foil or sheet stock by further proc-
few minutes after the last extractive has
been added. Add 80 milliliters of isooctane to
essing provided that the total residual
the solution and extract by shaking the fun- lubricant remaining on the metallic ar-
nel vigorously for 2 minutes. Draw off the ticle in the form in which it contacts
lower aqueous layer into a second separatory food does not exceed 0.2 milligram per
funnel (preferably 2-liter) and repeat the ex- square inch of food-contact surface:
traction with 80 milliliter of isooctane. Draw (1) Antioxidants used in compliance
off and discard the aqueous layer. Wash each
with regulations in parts 170 through
of the 80 milliliter extractives three times
with 100-milliliter portions distilled water. 189 of this chapter.
Shaking time for each wash is 1 minute. Dis- (2) Substances identified in this sub-
card the aqueous layers. Filter the first ex- paragraph.
Acetyl tributyl citrate.

Acetyl triethyl citrate.
Butyl stearate.
Castor oil.
Dibutyl sebacate.
Di(2-ethylhexyl) azelate.
Di(2-ethylhexyl) sebacate.
Diisodecyl phthalate.
Dimethylpolysiloxane ................................................................... Conforming to the identity prescribed in § 181.28 of this chap-
ter.
Dipropylene glycol.
Epoxidized soybean oil ................................................................ Conforming to the identity prescribed in § 181.27 of this chap-
ter.
451
§ 178.3930 21 CFR Ch. I (4–1–11 Edition)
Fatty acids derived from animal and vegetable fats and oils,
and salts of such acids, single or mixed, as follows:
Aluminum
Magnesium
Potassium
Sodium
Zinc
Fatty alcohols, straight-chain with even number carbon atoms
(C10 or greater).
Isobutyl stearate.
Lanolin.
Linoleic acid amide.
Mineral oil .................................................................................... Conforming to the identity prescribed in § 178.3620 (a) or (b).
Mono-, di-, and tristearyl citrate.
Oleic acid amide.
Palmitic acid amide.
Petrolatum ................................................................................... Conforming to the identity prescribed in § 178.3700.
Phosphoric acid, mono- and dihexyl esters, compounds with For use only at levels not to exceed 0.5 percent by weight of
tetramethylnonylamines and C11–14-alkylamines (CAS Reg. the finished surface lubricant formulation.
No. 80939–62–4).
Polyethylene glycol (molecular weight 300 or greater) ............... Mono- and diethylene glycol content not to exceed a total of
0.2 pct.
Stannous stearate.
Stearic acid amide.
Stearyl stearate.
Tetrakis[methylene (3,5-di-tert-butyl-4-hydroxyhydrocinnamate)] For use at a level not to exceed 0.5 percent by weight of the
methane (CAS Registry No. 6683–19–8). finished surface lubricant formulation.
Triethylene glycol ......................................................................... Diethylene glycol content not to exceed 0.1 pct.
Wax, petroleum ........................................................................... Complying with § 178.3710.
(c) The substances identified in para- with any applicable specifications pre-
graph (a)(2) of this section may be used scribed by such regulation.
in surface lubricants used to facilitate
the drawing, stamping, and forming of FR 238, Jan. 4, 1983; 49 FR 10113, Mar. 19, 1984;
metallic articles from rolled foil and 49 FR 29579, July 23, 1984; 50 FR 36874, Sept.
sheet stock provided that total resid- 10, 1985; 52 FR 10223, Mar. 31, 1987; 54 FR 6124,
ual lubricant remaining on the metal- Feb. 8, 1989; 54 FR 24899, June 12, 1989; 56 FR
lic article in the form in which it con- 55456, Oct. 28, 1991; 57 FR 23953, June 5, 1992;
58 FR 17513, Apr. 5, 1993; 64 FR 47110, Aug. 30,
tacts food does not exceed 0.015 milli-
1999; 69 FR 24512, May 4, 2004]
gram per square inch of food-contact
surface. § 178.3930 Terpene resins.
(d) Subject to any prescribed limita-
The terpene resins identified in para-
tions, the quantity of surface lubricant
graph (a) of this section may be safely
used in the manufacture of metallic ar-
used as components of polypropylene
ticles shall not exceed the least
film intended for use in contact with
amount reasonably required to accom- food, and the terpene resins identified
plish the intended technical effect and in paragraph (b) of this section may be
shall not be intended to nor, in fact, safely used as components of polyolefin
accomplish any technical effect in the film intended for use in contact with
food itself. food;
(e) The use of the surface lubricants (a) Terpene resins consisting of the
in the manufacture of any article that hydrogenated polymers of terpene hy-
is the subject of a regulation in parts drocarbons obtainable from sulfate tur-
174, 175, 176, 177, 178 and § 179.45 of this pentine and meeting the following
chapter must comply with any speci- specifications: Drop-softening point of
fications prescribed by such regulation 118°–138 °C; iodine value less than 20.
for the finished form of the article. (b) Terpene resins consisting of poly-
(f) Any substance that is listed in mers of beta-pinene and meeting the
this section and the subject of a regula- following specifications: Acid value
tion in parts 174, 175, 176, 177, 178 and less than 1; saponification number less
§ 179.45 of this chapter shall comply than 1; color less than 4 on the Gardner
452
scale as measured in 50 percent mineral Subpart C—Packaging Materials for

spirits solution. Irradiated Foods
§ 178.3940 Tetraethylene glycol di-(2- 179.45 Packaging materials for use during
ethylhexoate). the irradiation of prepackaged foods.
Tetraethylene glycol di-(2- AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 373,
ethylhexoate) containing not more 374.
than 22 parts per million ethylene and/ SOURCE: 42 FR 14635, Mar. 15, 1977, unless
or diethylene glycols may be used at a otherwise noted.
level not to exceed 0.7 percent by EDITORIAL NOTE: Nomenclature changes to
weight of twine as a finish on twine to part 179 appear at 70 FR 72074, Dec. 1, 2005.
be used for tying meat provided the
twine fibers are produced from nylon Subpart A [Reserved]
resins complying with § 177.1500 of this
chapter.
Subpart B—Radiation and
§ 178.3950 Tetrahydrofuran. Radiation Sources
Tetrahydrofuran may be safely used § 179.21 Sources of radiation used for
in the fabrication of articles intended inspection of food, for inspection of
for packaging, transporting, or storing packaged food, and for controlling
foods, subject to the provisions of this food processing.
section. Sources of radiation for the purposes
(a) It is used as a solvent in the cast- of inspection of foods, for inspection of
ing of film from a solution of poly- packaged food, and for controlling food
meric resins of vinyl chloride, vinyl ac- processing may be safely used under
etate, or vinylidene chloride that have the following conditions:
been polymerized singly or copolym- (a) The radiation source is one of the
erized with one another in any com- following:
bination, or it may be used as a solvent (1) X-ray tubes producing X-radiation
in the casting of film prepared from from operation of the tube source at a
vinyl chloride copolymers complying voltage of 500 kilovolt peak or lower.
(2) Sealed units producing radiations
(b) The residual amount of tetra- at energy levels of not more than 2.2
hydrofuran in the film does not exceed million electron volts from one of the
1.5 percent by weight of film. following isotopes: Americium-241, ce-
sium-137, cobalt-60, iodine-125, krypton-
PART 179—IRRADIATION IN THE 85, radium-226, and strontium-90.
PRODUCTION, PROCESSING AND (3) Sealed units producing neutron
HANDLING OF FOOD radiation from the isotope Califor-
nium-252 (CAS Reg. No. 13981–17–4) to
Subpart A [Reserved] measure moisture in food.
(4) Machine sources producing X-radi-
Subpart B—Radiation and Radiation ation at energies no greater than 10
Sources million electron volts (MeV).
Sec.
(5) Monoenergetic neutron sources
179.21 Sources of radiation used for inspec- producing neutrons at energies not less
tion of food, for inspection of packaged than 1 MeV but no greater than 14
food, and for controlling food processing. MeV.
179.25 General provisions for food irradia- (b) To assure safe use of these radi-
tion. ation sources:
179.26 Ionizing radiation for the treatment (1) The label of the sources shall
of food. bear, in addition to the other informa-
179.30 Radiofrequency radiation for the tion required by the Act:
heating of food, including microwave fre-
quencies.
(i) Appropriate and accurate informa-
tion identifying the source of radi-
179.39 Ultraviolet radiation for the proc-

essing and treatment of food. ation.
179.41 Pulsed light for the treatment of (ii) The maximum energy of radi-
food. ation emitted by X-ray tube sources.
453

CFR 2011 Title21 Vol3 Part178 Subpartd

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

CFR 2011 Title21 Vol3 Part178 Subpartd

Uploaded by

Copyright:

Available Formats

Food and Drug Administration, HHS § 178.

552(a). The availability of this incorpo- List of substances Limitations

List of substances Limitations

Alum (double sulfate of aluminum and ammonium, potassium, or sodium).

chapter. The average thickness of such ethylene-vinyl ace-

List of substances Limitations

Alpha-(Carboxymethyl)-omega-(tetradecyloxy)polyoxyethylene) For use only as an antistatic and/or antifogging agent at levels

List of substances Limitations

N,N-Bis(2-hydroxyethyl) alkylamine, where the alkyl groups For use only:

polyolefin film shall not exceed 0.02 centimeter (0.008 inch).

List of substances Limitations

[42 FR 14609, Mar. 15, 1977, as amended at 55 FR 8914, Mar. 9, 1990]

§ 178.3290 Chromic chloride com- nor exceed 7 micrograms of chromium

contact with food, subject to the provi-

Sodium 2,2′-methylenebis(4,6-di-tert-butylphenyl)phosphate For use only:

Cobalt aluminate .......................................................................... For use only:

ceed 275 °F.

Phthalocyanine green (C.I. pigment green 7, C.I. No. 74260).

Quinacridone red (C.I. Pigment violet 19, C.I. No. 73900).

[48 FR 46775, Oct. 14, 1983]

§ 178.3300 Corrosion inhibitors used List of substances Limitations

List of substances Limitations

have an acid number (to pH 5.2) of 103–111 and that are

List of substances Limitations

a-(p-Dodecylphenyl)-omega-hydroxypoly (oxyethylene) pro-

Polysorbate 65 conforming to the identity prescribed in

List of substances Limitations

Polysorbate 85 (polyoxyethylene (20) sorbitan trioleate) meet-

(a) They are used or intended for use www.archives.gov/federallregister/

tration (NARA). For information on stearate).

used as a component of articles in- § 178.3520 Industrial starch-modified.

Ammonium persulfate, not to exceed 0.3 pct. or in alkaline

(2) A starch irradiated under one of (ii) An electron beam source at a

(methacryloyloxy)ethyl] trimethylammonium methyl sul-

List of reactants Limitations

2. Not more than 0.20 pct residual acrylamide.

Ultraviolet absorbance: [42 FR 14609, Mar. 15, 1977, as amended at 47

tations affecting § 178.3570, see the List of

§ 178.3600 Methyl glucoside-coconut oil this chapter may be used as a compo-

the provisions of this section: dure described for application to min-

Official Agricultural Chemists,’’ Vol- reference is given in paragraph (b)(1)(i)

the bottom and a suitable ball-joint at the

(i) Distillation endpoint at 760 milli- D. A chromatographic column made from

As a defoamer in coatings .......................................................... Complying with § 176.200 of this chapter.

§ 178.3690 Pentaerythritol adipate-ste- NARA, call 202–741–6030, or go to: http://

National Archives and Records Admin- following conditions:

States Pharmacopeia XX (1980) for Ultraviolet absorbance per centi-

dure described in § 172.886(b) of this section may be safely used as pigment

Butylbenzyl phthalate .............................................. For use only:

they contact food shall not exceed 0.004 inch.

Diisononyl adipate ................................................... For use only:

Polybutene, hydrogenated (minimum viscosity at For use only:

(a) The additive is an addition poly- or diethylene glycol may be used at a

handling and to assure absence of any extra-

at NARA, call 202–741–6030, or go to: http://

rected absorbance does not exceed the limits

(4) Ultraviolet absorbance limits reference in accordance with 5 U.S.C.

neutralized with calcium hydroxide to reference. Copies are available from

(iii) Polymers identified in para- than 30 weight-percent of polymer

cracked petroleum stocks.

List of substances Limitations

Rosins and rosin derivatives ....................................................... As provided in § 178.3870.