This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated April 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178]
[Page 347-348]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart A [Reserved]
Subpart B--Substances Utilized To Control the Growth of Microorganisms
Sec.
178.1005 Hydrogen peroxide solution.
178.1010 Sanitizing solutions.
Subpart C--Antioxidants and Stabilizers
178.2010 Antioxidants and/or stabilizers for polymers.
178.2550 4-Hydroxymethyl-2,6-di-tert-butylphenol.
178.2650 Organotin stabilizers in vinyl chloride plastics.
[[Page 348]]
Subpart D--Certain Adjuvants and Production Aids
178.3010 Adjuvant substances used in the manufacture of foamed
plastics.
178.3120 Animal glue.
178.3125 Anticorrosive agents.
178.3130 Antistatic and/or antifogging agents in food-packaging
materials.
178.3280 Castor oil, hydrogenated.
178.3290 Chromic chloride complexes.
178.3295 Clarifying agents for polymers.
178.3297 Colorants for polymers.
178.3300 Corrosion inhibitors used for steel or tinplate.
178.3400 Emulsifiers and/or surface-active agents.
178.3450 Esters of stearic and palmitic acids.
178.3480 Fatty alcohols, synthetic.
178.3500 Glycerin, synthetic.
178.3505 Glyceryl tri-(12-acetoxystearate).
178.3520 Industrial starch-modified.
178.3530 Isoparaffinic petroleum hydrocarbons, synthetic.
178.3570 Lubricants with incidental food contact.
178.3600 Methyl glucoside-coconut oil ester.
178.3610 a-Methylstyrene-vinyltoluene resins, hydrogenated.
178.3620 Mineral oil.
178.3650 Odorless light petroleum hydrocarbons.
178.3690 Pentaerythritol adipate-stearate.
178.3700 Petrolatum.
178.3710 Petroleum wax.
178.3720 Petroleum wax, synthetic.
178.3725 Pigment dispersants.
178.3730 Piperonyl butoxide and pyrethrins as components of bags.
178.3740 Plasticizers in polymeric substances.
178.3750 Polyethylene glycol (mean molecular weight 200-9,500).
178.3760 Polyethylene glycol (400) monolaurate.
178.3770 Polyhydric alcohol esters of oxidatively refined (Gersthofen
process) montan wax acids.
178.3780 Polyhydric alcohol esters of long chain monobasic acids.
178.3790 Polymer modifiers in semirigid and rigid vinyl chloride
plastics.
178.3800 Preservatives for wood.
178.3850 Reinforced wax.
178.3860 Release agents.
178.3870 Rosins and rosin derivatives.
178.3900 Sodium pentachlorophenate.
178.3910 Surface lubricants used in the manufacture of metallic
articles.
178.3930 Terpene resins.
178.3940 Tetraethylene glycol di-(2-ethyl-hexoate).
178.3950 Tetrahydrofuran.
Authority: 21 U.S.C. 321, 342, 348, 379e.
Source: 42 FR 14609, Mar. 15, 1977, unless otherwise noted.
Editorial Note: Nomenclature changes to part 178 appear at 61 FR
14482, Apr. 2, 1996, 66 FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27,
2001, and 68 FR 15355, Mar. 31, 2003.
Subpart A [Reserved]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.1005]
[Page 348-349]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart B--Substances Utilized To Control the Growth of Microorganisms
Sec. 178.1005 Hydrogen peroxide solution.
Hydrogen peroxide solution identified in this section may be safely
used to sterilize polymeric food-contact surfaces identified in
paragraph (e)(1) of this section.
(a) Identity. For the purpose of this section, hydrogen peroxide
solution is an aqueous solution containing not more than 35 percent
hydrogen peroxide (CAS Reg. No. 7722-84-1) by weight, meeting the
specifications prescribed in paragraph (c) of this section.
(b) Optional adjuvant substances. Hydrogen peroxide solution
identified in paragraph (a) of this section may contain substances
generally recognized as safe in or on food, substances generally
recognized for their intended use in food packaging, substances used in
accordance with a prior sanction or approval, and substances permitted
by applicable regulations in parts 174 through 179 of this chapter.
(c) Specifications. Hydrogen peroxide solution shall meet the
specifications of the "Food Chemicals Codex," 3d Ed. (1981), pp. 146-
147, which is incorporated by reference (copies may be obtained from the
National Academy Press, 2101 Constitution Ave. NW., Washington, DC
20418, or may be examined at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408), and the
United States Pharmacopeia XX (1980), except that hydrogen peroxide may
exceed the concentration specified therein.
(d) Limitations. No use of hydrogen peroxide solution in the
sterilization of food packaging material shall be considered to be in
compliance if more than 0.5 part per million of hydrogen peroxide can be
determined in distilled water packaged under production conditions
(assay to be performed immediately after packaging).
[[Page 349]]
(e) Conditions of use. (1) Hydrogen peroxide solution identified in
and complying with the specifications in this section may be used by
itself or in combination with other processes to treat food-contact
surfaces to attain commercial sterility at least equivalent to that
attainable by thermal processing for metal containers as provided for in
part 113 of this chapter. Food-contact surfaces include the following:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Ethylene-acrylic acid copolymers.......... Complying with Sec.
177.1310 of this chapter.
Ethylene-carbon monoxide copolymers....... Complying with Sec.
177.1312 of this chapter.
Ethylene-methyl acrylate copolymer resins. Complying with Sec.
177.1340 of this chapter.
Ethylene-vinyl acetate copolymers......... Complying with Sec.
177.1350 of this chapter.
Ionomeric resins.......................... Complying with Sec.
177.1330 of this chapter.
Isobutylene polymers...................... Complying with Sec.
177.1420 (a)(1) and (a)(2)
of this chapter.
Olefin polymers........................... Complying with Sec.
177.1520 of this chapter.
Polycarbonate resins...................... Complying with Sec.
177.1580 of this chapter.
Polyethylene-terephthalate polymers....... Complying with Sec.
177.1630 of this chapter
(excluding polymers
described in Sec.
177.1630(c)) of this
chapter.
Poly-l-butene resins and butene/ethylene Complying with Sec.
copolymers. 177.1570 of this chapter.
Polystryrene and rubber-modified Complying with Sec.
polystyrene polymers. 177.1640 of this chapter.
Vinylidene chloride/methyl acrylate Complying with Sec.
copolymers. 177.1990 of this chapter.
------------------------------------------------------------------------
(2) The packaging materials identified in paragraph (e)(1) of this
section may be used for packaging all commercially sterile foods except
that the olefin polymers may be used in articles for packaging foods
only of the types identified in Sec. 176.170(c) of this chapter, table
1, under Categories I, II, III, IV-B, V, and VI.
(3) Processed foods packaged in the materials identified in
paragraph (e)(1) of this section shall conform with parts 108, 110, 113,
and 114 of this chapter as applicable.
[46 FR 2342, Jan. 9, 1981, as amended at 49 FR 10111, Mar. 19, 1984; 49
FR 32345, Aug. 14, 1984; 49 FR 37747, Sept. 26, 1984; 51 FR 45881, Dec.
23, 1986; 52 FR 26146, July 13, 1987; 53 FR 47186, Nov. 22, 1988; 54 FR
5604, Feb. 6, 1989; 54 FR 13167, Mar. 31, 1989; 54 FR 6365 Feb. 9, 1989;
55 FR 47055, Nov. 9, 1990; 57 FR 32423, July 22, 1992]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.1010]
[Page 349-358]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart B--Substances Utilized To Control the Growth of Microorganisms
Sec. 178.1010 Sanitizing solutions.
Sanitizing solutions may be safely used on food-processing equipment
and utensils, and on other food-contact articles as specified in this
section, within the following prescribed conditions:
(a) Such sanitizing solutions are used, followed by adequate
draining, before contact with food.
(b) The solutions consist of one of the following, to which may be
added components generally recognized as safe and components which are
permitted by prior sanction or approval.
(1) An aqueous solution containing potassium, sodium, or calcium
hypochlorite, with or without the bromides of potassium, sodium, or
calcium.
(2) An aqueous solution containing dichloroisocyanuric acid,
trichloroisocyanuric acid, or the sodium or potassium salts of these
acids, with or without the bromides of potassium, sodium, or calcium.
(3) An aqueous solution containing potassium iodide, sodium p-
toluenesulfonchloroamide, and sodium lauryl sulfate.
(4) An aqueous solution containing iodine, butoxy monoether of mixed
(ethylene-propylene) polyalkylene glycol having a cloudpoint of 90 deg.-
100 deg.C in 0.5 percent aqueous solution and an average molecular
weight of 3,300, and ethylene glycol monobutyl ether. Additionally, the
aqueous solution may contain diethylene glycol monoethyl ether as an
optional ingredient.
(5) An aqueous solution containing elemental iodine, hydriodic acid,
a-(p-nonylphenyl)-omega-hydroxypoly-(oxyethylene) (complying with the
identity prescribed in Sec. 178.3400(c) and having a maximum average
molecular weight of 748) and/or polyoxyethylene-polyoxypropylene block
polymers (having a minimum average molecular weight of 1,900).
Additionally, the aqueous solution may contain isopropyl alcohol as an
optional ingredient.
(6) An aqueous solution containing elemental iodine, sodium iodide,
sodium dioctylsulfosuccinate, and polyoxyethylene-polyoxypropylene block
polymers (having a minimum average molecular weight of 1,900).
(7) An aqueous solution containing dodecylbenzenesulfonic acid and
either isopropyl alcohol or polyoxyethylene-
[[Page 350]]
polyoxypropylene block polymers (having a minimum average molecular
weight of 2,800). In addition to use on food-processing equipment and
utensils, this solution may be used on glass bottles and other glass
containers intended for holding milk.
(8) An aqueous solution containing elemental iodine, butoxy
monoether of mixed (ethylene-propylene) polyalkylene glycol having a
minimum average molecular weight of 2,400 and [alpha]-lauroyl-omega-
hydroxypoly (oxyethylene) with an average 8-9 moles of ethylene oxide
and an average molecular weight of 400. In addition to use on food-
processing equipment and utensils, this solution may be used on beverage
containers, including milk containers or equipment. Rinse water treated
with this solution can be recirculated as a preliminary rinse. It is not
to be used as final rinse.
(9) An aqueous solution containing n-alkyl (C12-
C18) benzyldimethylam-monium chloride compounds having
average molecular weights of 351 to 380. The alkyl groups consist
principally of groups with 12 to 16 carbon atoms and contain not more
than 1 percent each of groups with 8 and 10 carbon atoms. Additionally,
the aqueous solution may contain either ethyl alcohol or isopropyl
alcohol as an optional ingredient.
(10) An aqueous solution containing trichloromelamine and either
sodium lauryl sulfate or dodecyl- benzenesulfonic acid. In addition to
use on food-processing equipment and utensils and other food-contact
articles, this solution may be used on beverage containers except milk
containers or equipment.
(11) An aqueous solution containing equal amounts of n-alkyl
(C12-C18) benzyl dimethyl ammonium chloride and n-
alkyl (C12-C18) dimethyl ethylbenzyl ammonium
chloride (having an average molecular weight of 384). In addition to use
on food-processing equipment and utensils, this solution may be used on
food-contact surfaces in public eating places.
(12) An aqueous solution containing the sodium salt of sulfonated
oleic acid, polyoxyethylene-polyoxypropylene block polymers (having an
average molecular weight of 2,000 and 27 to 31 moles of
polyoxypropylene). In addition to use on food-processing equipment and
utensils, this solution may be used on glass bottles and other glass
containers intended for holding milk. All equipment, utensils, glass
bottles, and other glass containers treated with this sanitizing
solution shall have a drainage period of 15 minutes prior to use in
contact with food.
(13) An aqueous solution containing elemental iodine and alkyl
(C12-C15) monoether of mixed (ethylene-propylene)
polyalkylene glycol, having a cloud-point of 70 deg.-77 deg.C in 1
percent aqueous solution and an average molecular weight of 807.
(14) An aqueous solution containing iodine, butoxy monoether of
mixed (ethylene-propylene) polyalkylene glycol, having a cloud-point of
90 deg.-100 deg.C in 0.5 percent aqueous solution and an average
molecular weight of 3,300, and polyoxyethylene-polyoxypropylene block
polymers (having a minimum average molecular weight of 2,000).
(15) An aqueous solution containing lithium hypochlorite.
(16) An aqueous solution containing equal amounts of n-alkyl
(C12-C18) benzyl dimethyl ammonium chloride and n-
alkyl (C12-C14) dimethyl ethylbenzyl ammonium
chloride (having average molecular weights of 377 to 384), with the
optional adjuvant substances tetrasodium ethylenediaminetetraacetate
and/or alpha-(p-nonylphenol)-omega-hydroxy poly (oxyethylene) having an
average poly- (oxyethylene) content of 11 moles. Alpha-hydro-omega-
hydroxypoly-(oxyethylene) poly(oxypropoylene) (15 to 18 mole minimum)
poly (oxyethylene) block copolymer, having a minimum molecular weight of
1,900 (CAS Registry No. 9003-11-6) may be used in lieu of alpha- (p-
nonylphenol)-omega-hydroxy- poly(oxyethylene) having an average
poly(oxyethylene) content of 11 moles. In addition to use on food-
processing equipment and utensils, this solution may be used on food-
contact surfaces in public eating places.
(17) An aqueous solution containing di-n-alkyl(C8-
C10)dimethyl ammonium chlorides having average molecular
weights of 332-361 and either ethyl alcohol or isopropyl alcohol. In
addition
[[Page 351]]
to use on food-processing equipment and utensils, this solution may be
used on food-contact surfaces in public eating places.
(18) An aqueous solution containing n-alkyl(C12-
C18) benzyldimethylammo-nium chloride, sodium metaborate,
alpha-terpineol and alpha[p-(1,1,3,3-tetramethylbutyl)phenyl] -omega-
hydroxy-poly (oxyethylene) produced with one mole of the phenol and 4 to
14 moles ethylene oxide.
(19) An aqueous solution containing sodium dichloroisocyanurate and
tetrasodium ethylenediaminetetraacetate. In addition to use on food-
processing equipment and utensils, this solution may be used on food-
contact surfaces in public eating places.
(20) An aqueous solution containing ortho-phenylphenol, ortho-
benzyl-para-chlorophenol, para-tertiaryamylphenol, sodium -alpha-
alkyl(C12-C15)-omega-hydroxypoly (oxyethylene)
sulfate with the poly(oxyethylene) content averaging one mole, potassium
salts of coconut oil fatty acids, and isopropyl alcohol or hexylene
glycol.
(21) An aqueous solution containing sodium dodecylbenzenesulfonate.
In addition to use on food-processing equipment and utensils, this
solution may be used on glass bottles and other glass containers
intended for holding milk.
(22) An aqueous solution containing (1) di-n-alkyl(C8-
C10) dimethylammonium chloride compounds having average
molecular weights of 332-361, (2) n-alkyl (C12-
C18) benzyldimethylammonium chloride compounds having average
molecular weights of 351-380 and consisting principally of alkyl groups
with 12 to 16 carbon atoms with or without not over 1 percent each of
groups with 8 and 10 carbon atoms, and (3) ethyl alcohol. The ratio of
compound (1) to compound (2) is 60 to 40.
(23) An aqueous solution containing n-alkyl (C12-
C16) benzyl-dimethylammonium chloride and
didecyldimethylammonium chloride.
(24) An aqueous solution containing elemental iodine (CAS Reg. No.
7553-56-2), alpha-[p-(1,1,3,3-tetramethylbutyl)-phenyl]-omega-
hydroxypoly-(oxyethylene) produced with one mole of the phenol and 4 to
14 moles ethylene oxide, and alpha-alkyl(C12-C15)-
omega-hydroxy[poly(oxyethylene) poly(oxypropylene)] (having an average
molecular weight of 965).
(25) An aqueous solution containing elemental iodine (CAS Reg. No.
7553-56-2), potassium iodide (CAS Reg. No. 7681-11-0), and isopropanol
(CAS Reg. No. 67-63-0). In addition to use on food processing equipment
and utensils, this solution may be used on beverage containers,
including milk containers and equipment and on food-contact surfaces in
public eating places.
(26) [Reserved]
(27) An aqueous solution containing decanoic acid (CAS Reg. No. 334-
48-5), octanoic acid (CAS Reg. No. 124-07-2), and sodium 1-
octanesulfonate (CAS Reg. No. 5324-84-5). Additionally, the aqueous
solution may contain isopropyl alcohol (CAS Reg. No. 67-63-0) as an
optional ingredient.
(28) An aqueous solution containing sulfonated 9-octadecenoic acid
(CAS Reg. No. 68988-76-1) and sodium xylenesulfonate (CAS Reg. No. 1300-
72-7).
(29) An aqueous solution containing dodecyldiphenyloxidedisulfonic
acid (CAS Reg. No. 30260-73-2), sulfonated tall oil fatty acid (CAS Reg.
No. 68309-27-3), and neo-decanoic acid (CAS Reg. No. 26896-20-8). In
addition to use on food-processing equipment and utensils, this solution
may be used on glass bottles and other glass containers intended for
holding milk.
(30) An aqueous solution containing hydrogen peroxide (CAS Reg. No.
7722-84-1), peracetic acid (CAS Reg. No. 79-21-0), acetic acid (CAS Reg.
No. 64-19-7), and 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg.
No. 2809-21-4).
(31) An aqueous solution containing elemental iodine, alpha-
alkyl(C10-C14)-omega-hydroxypoly(oxyethylene)poly-
(oxypropylene) of average molecular weight between 768 and 837, and
alpha-alkyl(C12-C18)-omega-
hydroxypoly(oxyethylene) poly(oxypropylene) of average molecular weight
between 950 and 1,120. In addition to use on food-processing equipment
and utensils, this solution may be used on food-contact surfaces in
public eating places.
[[Page 352]]
(32) An aqueous solution containing (i) di-n-alkyl(C8-
C10)dimethyl- ammonium chloride compounds having average
molecular weights of 332 to 361, (ii) n-alkyl(C12-
C18)benzyldimethyl- ammonium chloride compounds having
average molecular weights of 351 to 380 and consisting principally of
alkyl groups with 12 to 16 carbon atoms with no more than 1 percent of
groups with 8 and 10, (iii) ethyl alcohol, and (iv) alpha-(p-
nonylphenyl)-omega-hydroxypoly(oxyethylene) produced by the condensation
of 1 mole of p-nonylphenol with 9 to 12 moles of ethylene oxide. The
ratio of compound (i) to compound (ii) is 3 to 2.
(33) An aqueous solution containing (i) di-n-alkyl-(C8-
C10)-dimethylammonium chloride compounds having average
molecular weights of 332 to 361; (ii) n-alkyl(C12-
C18) -benzyldimethylammonium chloride compounds having
molecular weights of 351 to 380 and consisting principally of alkyl
groups with 12 to 16 carbon atoms with no more than 1 percent of the
groups with 8 to 10; and (iii) tetrasodium ethylenediamine tetraacetate.
Additionally, the aqueous solution contains either alpha-(p-
nonylphenyl)-omega-hydroxypoly-(oxyethylene) or alpha-
alkyl(C11-C15)-omega-hydroxypoly-(oxyethylene),
each produced with 9 to 13 moles of ethylene oxide. The ratio of
compound (i) to compound (ii) is 3 to 2.
(34) An aqueous solution of an equilibrium mixture of oxychloro
species (predominantly chlorite, chlorate, and chlorine dioxide)
generated either (i) by directly metering a concentrated chlorine
dioxide solution, prepared just prior to use, into potable water to
provide the concentration of available chlorine dioxide stated in
paragraph (c)(29) of this section, or (ii) by acidification of an
aqueous alkaline solution of oxychloro species (predominantly chlorite
and chlorate) followed by dilution with potable water to provide the
concentration of available chlorine dioxide described in paragraph
(c)(29) of this section.
(35) An aqueous solution containing decanoic acid (CAS Reg. No. 334-
48-5), octanoic acid (CAS Reg. No. 124-07-2), lactic acid (CAS Reg. No.
050-21-5), phosphoric acid (CAS Reg. No. 7664-38-2) and a mixture of the
sodium salt of naphthalenesulfonic acid (CAS Reg. No. 1321-69-3); the
methyl, dimethyl, and trimethyl dervatives of the sodium salt of
naphthalenesulfonic acid; and a mixture of the sodium salt of
naphthalenesulfonic acid, and the methyl, dimethyl, and trimethyl
derivatives of the sodium salt of naphthalenesulfonic acid alkylated at
3 percent by weight with C6-C9 linear olefins, as
components of a sanitizing solution to be used on food-processing
equipment and utensils. The methyl and dimethyl substituted derivatives
(described within this paragraph (b)(35)) constitute no less than 70
percent by weight of the mixture of naphthalenesulfonates.
(36) The sanitizing solution contains decanoic acid (CAS Reg. No.
334-48-5); octanoic acid (CAS Reg. No. 124-07-2); lactic acid (CAS Reg.
No. 050-21-5); phosphoric acid (CAS Reg. No. 7664-38-2); a mixture of 1-
octanesulfonic acid (CAS Reg. No. 3944-72-7), and 1-octanesulfonic-2-
sulfinic acid (CAS Reg. No. 113652-56-5) or 1,2-octanedisulfonic acid
(CAS Reg. No. 1934210); the condensate of four moles of
poly(oxyethylene)poly(oxypropylene) block copolymers with one mole of
ethylenediamine (CAS Reg. No. 11111-34-5); and the optional ingredient
FD&C Yellow No. 5 (CAS Reg. No. 001934210). In addition to use on food-
processing equipment and utensils, this solution may be used on dairy-
processing equipment.
(37) The sanitizing solution contains sodium hypochlorite (CAS Reg.
No. 7681-52-9), trisodium phosphate (CAS Reg. No. 7601-54-9), sodium
lauryl sulfate (CAS Reg. No. 151-21-3), and potassium permanganate (CAS
Reg. No. 7722-64-7). Magnesium oxide (CAS Reg. No. 1309-48-4) and
potassium bromide (CAS Reg. No. 7758-02-3) may be added as optional
ingredients to this sanitizing solution. In addition to use on food-
processing equipment and utensils, this solution may be used on food-
contact surfaces in public eating places.
(38) An aqueous solution containing hydrogen peroxide (CAS Reg. No.
7722-84-1); peroxyacetic acid (CAS Reg. No. 79-21-0); acetic acid (CAS
Reg. No. 64-
[[Page 353]]
19-7); sulfuric acid (CAS Reg. No. 7664-93-9); and 2,6-
pyridinedicarboxylic acid (CAS Reg. No. 499-83-2). In addition to use on
food-processing equipment and utensils, this solution may be used on
dairy-processing equipment.
(39) An aqueous solution containing phosphoric acid (CAS Reg. No.
7664-38-2); octenyl succinic acid (CAS Reg. No. 28805-58-5); N,N-
dimethyloctanamine (CAS Reg. No. 7378-99-6); and a mixture of n-
carboxylic acids (C6-C12, consisting of not less
than 56 percent octanoic acid and not less than 40 percent decanoic
acid). This solution may be used on food-processing equipment and
utensils, including dairy-processing equipment.
(40) An aqueous solution prepared by combining elemental iodine (CAS
Reg. No. 7553-56-2); hydriodic acid (CAS Reg. No. 10034-85-2); sodium N-
cyclohexyl-N-palmitoyl taurate (CAS Reg. No. 132-43-4); chloroacetic
acid, sodium salt reaction products with 4,5-dihydro-2-undecyl-1H-
imidazole-1-ethanol and sodium hydroxide (CAS Reg. No. 68608-66-2);
dodecylbenzene sulfonic acid (CAS Reg. No. 27176-87-0); phosphoric acid
(CAS Reg. No. 7664-38-2); isopropyl alcohol (CAS Reg. No. 67-63-0); and
calcium chloride (CAS Reg. No. 10043-52-4). In addition to use on food-
processing equipment and utensils, this solution may be used on dairy-
processing equipment.
(41) An aqueous solution containing n-alkyl(C12-
C16)benzyldimethylammonium chloride, having average molecular
weights ranging from 351 to 380 wherein the alkyl groups contain
principally 12 to 16 carbons and not more than 1 percent each of the
groups with 8 and 10 carbon atoms; ammonium chloride (CAS Reg. No.
12125-02-9); calcium stearate (CAS Reg. No. 1592-23-0); sodium
bicarbonate (CAS Reg. No. 144-55-8); starch or dextrin, or both starch
and dextrin (CAS Reg. No. 9004-53-9); and the optional ingredient
methylene blue (CAS Reg. No. 61-73-4). In addition to use on food-
processing equipment and utensils, this solution may be used on food-
contact surfaces in public eating places.
(42) An aqueous solution containing decanoic acid (CAS Reg. No. 334-
48-5), nonanoic acid (CAS Reg. No. 112-05-0), phosphoric acid (CAS Reg.
No. 7664-38-2), propionic acid (CAS Reg No. 79-09-04), and sodium 1-
octanesulfonate (CAS Reg. No. 5324-84-5). Sulfuric acid (CAS Reg. No.
7664-93-9) may be added as an optional ingredient. In addition to use on
food-processing equipment and utensils, this solution may be used on
dairy-processing equipment.
(43) An aqueous solution of iodine and hypochlorous acid generated
by the dilution of an aqueous acidic (21.5 percent nitric acid) solution
of iodine monochloride. In addition to use on food-processing equipment
and utensils, this solution may be used on dairy-processing equipment.
(44) An aqueous solution of citric acid, disodium
ethylenediaminetetraacetate, sodium lauryl sulfate, and monosodium
phosphate. In addition to use on food-processing equipment and utensils,
this solution may be used on dairy-processing equipment.
(45) An aqueous solution of hydrogen peroxide, acetic acid,
peroxyacetic acid, octanoic acid, peroxyoctanoic acid, sodium 1-
octanesulfonate, and 1-hydroxyethylidene-1,1-diphosphonic acid. In
addition to use on food-processing equipment and utensils, this solution
may be used on food-contact surfaces in public eating places, subject to
the limitations in paragraph (c)(39) of this section.
(46) An aqueous solution of chlorine dioxide and related oxychloro
species generated by acidification of an aqueous solution of sodium
chlorite with a solution of sodium gluconate, citric acid, phosphoric
acid, and sodium mono- and didodecylphenoxybenzenedisulfonate. In
addition to use on food-processing equipment and utensils, this solution
may be used on dairy-processing equipment.
(c) The solutions identified in paragraph (b) of this section will
not exceed the following concentrations:
(1) Solutions identified in paragraph (b)(1) of this section will
provide not more than 200 parts per million of available halogen
determined as available chlorine.
(2) Solutions identified in paragraph (b)(2) of this section will
provide not more than 100 parts per million of
[[Page 354]]
available halogen determined as available chlorine.
(3) Solution identified in paragraph (b)(3) of this section will
provide not more than 25 parts per million of titratable iodine. The
solutions will contain the components potassium iodide, sodium p-
toluenesulfonchloramide and sodium lauryl sulfate at a level not in
excess of the minimum required to produce their intended functional
effect.
(4) Solutions identified in paragraph (b)(4), (5), (6), (8), (13),
and (14) of this section will contain iodine to provide not more than 25
parts per million of titratable iodine. The adjuvants used with the
iodine will not be in excess of the minimum amounts required to
accomplish the intended technical effect.
(5) Solutions identified in paragraph (b)(7) of this section will
provide not more than 400 parts per million dodecylbenzenesulfonic acid
and not more than 80 parts per million of polyoxyethylene-
polyoxypropylene block polymers (having a minimum average molecular
weight of 2,800) or not more than 40 parts per million of isopropyl
alcohol.
(6) Solutions identified in paragraph (b)(9) of this section shall
provide when ready to use no more than 200 parts per million of the
active quaternary compound.
(7) Solutions identified in paragraph (b)(10) of this section shall
provide not more than sufficient trichloromelamine to produce 200 parts
per million of available chlorine and either sodium lauryl sulfate at a
level not in excess of the minimum required to produce its intended
functional effect or not more than 400 parts per million of
dodecylbenzenesulfonic acid.
(8) Solutions identified in paragraph (b)(11) of this section shall
provide, when ready to use, not more than 200 parts per million of
active quaternary compound.
(9) The solution identified in paragraph (b)(12) of this section
shall provide not more than 200 parts per million of sulfonated oleic
acid, sodium salt.
(10) Solutions identified in paragraph (b)(15) of this section will
provide not more than 200 parts per million of available chlorine and
not more than 30 ppm lithium.
(11) Solutions identified in paragraph (b)(16) of this section shall
provide not more than 200 parts per million of active quaternary
compound.
(12) Solutions identified in paragraph (b)(17) of this section shall
provide, when ready to use, a level of 150 parts per million of the
active quaternary compound.
(13) Solutions identified in paragraph (b)(18) of this section shall
provide not more than 200 parts per million of active quaternary
compound and not more than 66 parts per million of alpha[p-(1,1,3,3-
tetramethylbutyl) phenyl]-omega-hydroxypoly (oxyethylene).
(14) Solutions identified in paragraph (b)(19) of this section shall
provide, when ready to use, a level of 100 parts per million of
available chlorine.
(15) Solutions identified in paragraph (b)(20) of this section are
for single use applications only and shall provide, when ready to use, a
level of 800 parts per million of total active phenols consisting of 400
parts per million ortho-phenylphenol, 320 parts per million ortho-
benzyl-para-chlorophenol and 80 parts per million para-
tertiaryamylphenol.
(16) Solution identified in paragraph (b)(21) of this section shall
provide not more than 430 parts per million and not less than 25 parts
per million of sodium dodecylbenzenesulfonate.
(17) Solutions identified in paragraph (b)(22) of this section shall
provide, when ready to use, at least 150 parts per million and not more
than 400 parts per million of active quaternary compound.
(18) Solutions identified in paragraph (b)(23) of this section shall
provide at least 150 parts per million and not more than 200 parts per
million of the active quaternary compound.
(19) Solutions identified in paragraphs (b)(24), (b)(25), and
(b)(43) of this section shall provide at least 12.5 parts per million
and not more than 25 parts per million of titratable iodine. The
adjuvants used with the iodine shall not be in excess of the minimum
amounts required to accomplish the intended technical effect.
(20)-(21) [Reserved]
[[Page 355]]
(22) Solutions identified in paragraph (b)(27) of this section shall
provide, when ready to use, at least 109 parts per million and not more
than 218 parts per million of total active fatty acids and at least 156
parts per million and not more than 312 parts per million of the sodium
1-octanesulfonate.
(23) Solutions identified in paragraph (b)(28) of this section shall
provide, when ready to use, at least 156 parts per million and not more
than 312 parts per million of sulfonated 9-octadecenoic acid, at least
31 parts per million and not more then 62 parts per million of sodium
xylenesulfonate.
(24) Solutions identified in paragraph (b)(29) of this section will
provide at least 237 parts per million and not more than 474 parts per
million dodecyldiphenyloxidedisulfonic acid, at least 33 parts per
million and not more than 66 parts per million sulfonated tall oil fatty
acid, and at least 87 parts per million and not more than 174 parts per
million neo-decanoic acid.
(25) Solutions identified in paragraph (b)(30) of this section shall
provide, when ready to use, not less than 550 parts per million and not
more than 1,100 parts per million hydrogen peroxide, not less than 100
parts per million and not more than 200 parts per million peracetic
acid, not less than 150 parts per million and not more than 300 parts
per million acetic acid, and not less than 15 parts per million and not
more than 30 parts per million 1-hydroxyethylidene-1,1-diphosphonic
acid.
(26) The solution identified in paragraph (b)(31) of this section
shall provide, when ready to use, at least 12.5 parts per million and
not more than 25 parts per million of titratable iodine. The adjuvants
used with the iodine will not be in excess of the minimum amounts
required to accomplish the intended technical effect.
(27) Solutions identified in paragraph (b)(32) of this section shall
provide, when ready to use, at least 150 parts per million and no more
than 400 parts per million of active quarternary compounds in solutions
containing no more than 600 parts per million water hardness. The
adjuvants used with the quarternary compounds will not exceed the
amounts required to accomplish the intended technical effect.
(28) Solutions identified in paragraph (b)(33) of this section shall
provide, when ready to use, at least 150 parts per million and not more
than 400 parts per million of active quaternary compounds. The adjuvants
used with the quaternary compounds shall not exceed the amounts required
to accomplish the intended technical effect. Tetrasodium ethylenediamine
tetraacetate shall be added at a minimum level of 60 parts per million.
Use of these sanitizing solutions shall be limited to conditions of
water hardness not in excess of 300 parts per million.
(29) Solutions identified in paragraph (b)(34) of this section
should provide, when ready to use, at least 100 parts per million and
not more than 200 parts per million available chlorine dioxide as
determined by the method titled "Iodometric Method for the
Determination of Available Chlorine Dioxide (50-250 ppm available
ClO2)," which is incorporated by reference. Copies are
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(30) Solutions identified in paragraph (b)(35) of this section shall
provide, when ready for use, at least 117 parts per million and not more
than 234 parts per million of total fatty acids and at least 166 parts
per million and not more than 332 parts per million of a mixture of
naphthalenesulfonates. The adjuvants phosphoric acid and lactic acid,
used with decanoic acid, octanoic acid, and sodium naphthalenesulfonate
and its alkylated derivatives, will not be in excess of the minimum
amounts required to accomplish the intended technical effects.
(31) Solutions identified in paragraph (b)(36) of this section shall
provide, when ready for use, at least 29 parts per million and not more
than 58 parts per million decanoic acid; at least 88 parts per million
and not more than 176 parts per million of octanoic acid; at least 69
parts per million and not more than 138 parts per million of lactic
acid; at least
[[Page 356]]
256 parts per million and not more than 512 parts per million of
phosphoric acid; at least 86 parts per million and not more than 172
parts per million of 1-octanesulfonic acid; at least 51 parts per
million and not more than 102 parts per million of 1-octanesulfonic-2-
sulfinic acid or 1,2-octanedisulfonic acid; and at least 10 parts per
million and not more than 20 parts per million of the condensate of four
moles of poly(oxyethylene)poly(oxypropylene) block copolymers with one
mole of ethylenediamine. The colorant adjuvant FD&C Yellow No. 5 shall
not be used in excess of the minimum amount required to accomplish the
intended technical effect.
(32)(i) The solution identified in paragraph (b)(37) of this section
without potassium bromide shall provide, when ready to use, at least 100
parts per million and not more than 200 parts per million of available
halogen determined as available chlorine; at least 2,958 parts per
million and not more than 5,916 parts per million of trisodium
phosphate; at least 1 part per million and not more than 3 parts per
million of sodium lauryl sulfate; and at least 0.3 part per million and
not more than 0.7 part per million on potassium permanganate.
(ii) The solution identified in paragraph (b)(37) of this section
with potassium bromide shall provide, when ready to use, at least 25
parts per million and not more than 200 parts per million of available
halogen determined as available chlorine; at least 15 parts per million
and not more than 46 parts per million of potassium bromide; at least
690 parts per million and not more than 2,072 parts per million of
trisodium phosphate; at least 0.3 part per million and not more than 1
part per million of sodium lauryl sulfate; and at least 0.1 part per
million and not more than 0.3 part per million of potassium
permanganate.
(iii) Magnesium oxide when used in paragraph (c)(32) (i) or (ii) of
this section shall not be used in excess of the minimum amount required
to accomplish its intended technical effect.
(33) Solutions identified in paragraph (b)(38) of this section shall
provide when ready for use not less than 300 parts per million and not
more than 465 parts per million of hydrogen peroxide; not less than 200
parts per million and not more than 315 parts per million of
peroxyacetic acid; not less than 200 parts per million and not more than
340 parts per million of acetic acid; not less than 10 parts per million
and not more than 20 parts per million of sulfuric acid; and not less
than 0.75 parts per million and not more than 1.2 parts per million of
2,6-pyridinedicarboxylic acid.
(34) Solutions identified in paragraph (b)(39) of this section shall
provide when ready for use not less than 460 parts per million and not
more than 625 parts per million of phosphoric acid, and all components
shall be present in the following proportions: 1 part phosphoric acid to
0.25 octenyl succinic acid to 0.18 part N,N-dimethyloctanamine to 0.062
part of a mixture of n-carboxylic acids (C6-C12,
consisting of not less than 56 percent octanoic acid and not less than
40 percent decanoic acid).
(35) Solutions identified in paragraph (b)(40) of this section shall
provide when ready for use not less than 12.5 parts per million and not
more than 25.0 parts per million of titratable iodine; and not less than
2.7 parts per million and not more than 5.5 parts per million of
dodecylbenzene sulfonic acid. All components shall be present in the
following proportions: 1.0 part dodecylbenzene sulfonic acid to 43 parts
sodium N-cyclohexyl-N-palmitoyl taurate to 7.7 parts chloroacetic acid,
sodium salt, reaction products with 4,5-dihydro-2-undecyl-1H-imidazole-
1-ethanol and sodium hydroxide to 114 parts phosphoric acid to 57 parts
isopropyl alcohol to 3.0 parts calcium chloride.
(36) Solutions identified in paragraph (b)(41) of this section shall
provide, when ready for use, not less than 150 parts per million and not
more than 200 parts per million of n-alkyl(C12-
C16)benzyldimethylammonium chloride; and not more than 0.4
part per million of the colorant methylene blue. Components shall be
present in the product used to prepare the solution in the following
proportions: 1 part n-alkyl(C12-
C16)benzyldimethylammonium chloride to 0.24 part ammonium
chloride to 0.08 part calcium stearate to 0.60 part sodium bicarbonate
to 0.08 part starch or
[[Page 357]]
dextrin, or a combination of starch and dextrin.
(37)(i) The solution identified in paragraph (b)(42) of this section
not containing sulfuric acid shall provide when ready for use not less
than 45 parts per million and not more than 90 parts per million of
decanoic acid; and all components shall be present in the following
proportions (weight/weight (w/w)): 1 part decanoic acid to 1 part
nonanoic acid to 9.5 parts phosphoric acid to 3.3 parts propionic acid
to 3.3 parts sodium 1-octanesulfonate.
(ii) The solution identified in paragraph (b)(42) of this section
containing sulfuric acid shall provide when ready for use not less than
45 parts per million and not more than 90 parts per million of decanoic
acid; and all components shall be present in the following proportions
(w/w): 1 part decanoic acid to 1 part nonanoic acid to 2.8 parts
phosphoric acid to 3.3 parts propionic acid to 3.3 parts sodium 1-
octanesulfonate to 3.2 parts sulfuric acid.
(38) The solution identified in paragraph (b)(44) of this section
shall provide, when ready for use, at least 16,450 parts per million and
not more than 32,900 parts per million of citric acid; at least 700
parts per million and not more than 1,400 parts per million of disodium
ethylenediaminetetraacetate; at least 175 parts per million and not more
than 350 parts per million of sodium lauryl sulfate; and at least 175
parts per million and not more than 350 parts per million of monosodium
phosphate.
(39)(i) The solution identified in paragraph (b)(45) of this
section, when used on food processing equipment and utensils, including
dairy and beverage-processing equipment but excluding food-contact
surfaces in public eating places and dairy and beverage containers,
shall provide when ready for use at least 72 parts per million and not
more than 216 parts per million of hydrogen peroxide; at least 46 parts
per million and not more than 138 parts per million of peroxyacetic
acid; at least 40 parts per million and not more than 122 parts per
million of octanoic acid (including peroxyoctanoic acid); at least 281
parts per million and not more than 686 parts per million of acetic
acid; at least 7 parts per million and not more than 34 parts per
million of 1-hydroxyethylidene-1,1-diphosphonic acid; and at least 36
parts per million and not more than 109 parts per million of sodium 1-
octanesulfonate.
(ii) The solution identified in paragraph (b)(45) of this section,
when used on food-contact equipment and utensils in warewashing
machines, including warewashing machines in public eating places, at
temperatures no less than 120 deg.F (49 deg.C) shall provide when
ready for use at least 30 parts per million and not more than 91 parts
per million of hydrogen peroxide; at least 19 parts per million and not
more than 58 parts per million of peroxyacetic acid; at least 17 parts
per million and not more than 52 parts per million of octanoic acid
(including peroxyoctanoic acid); at least 119 parts per million and not
more than 290 parts per million of acetic acid; at least 3 parts per
million and not more than 14 parts per million of 1-hydroxyethylidene-
1,1-diphosphonic acid; and at least 15 parts per million and not more
than 46 parts per million of sodium 1-octanesulfonate.
(iii) The solution identified in paragraph (b)(45) of this section,
when used on dairy or beverage containers, shall provide when ready for
use at least 36 parts per million and not more than 108 parts per
million of hydrogen peroxide; at least 23 parts per million and not more
than 69 parts per million of peroxyacetic acid; at least 20 parts per
million and not more than 61 parts per million of octanoic acid
(including peroxyoctanoic acid); at least 140 parts per million and not
more than 343 parts per million of acetic acid; at least 3 parts per
million and not more than 17 parts per million of 1-hydroxyethylidene-
1,1-diphosphonic acid; and at least 18 parts per million and not more
than 55 parts per million of sodium 1-octanesulfonate.
(40) The solution identified in paragraph (b)(46) of this section
shall provide, when ready for use, at least 100 parts per million and
not more than 200 parts per million of chlorine dioxide as determined by
the method developed by Bio-cide International, Inc., entitled,
"Iodometric Method for the Determination of Available Chlorine Dioxide
(50-250 ppm Available ClO2),"
[[Page 358]]
dated June 11, 1987, which is incorporated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this method are
available from the Division of Petition Control, Center for Food Safety
and Applied Nutrition (HFS-215), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, and may be examined at the
Center for Food Safety and Applied Nutrition's Library, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at
the Office of the Federal Register, 800 North Capitol St. NW., suite
700, Washington, DC; at least 380 parts per million and not more than
760 parts per million of sodium gluconate; and at least 960 parts per
million and not more than 1,920 parts per million of sodium mono- and
didodecylphenoxybenzenedisulfonate. Other components listed under
paragraph (b)(46) of this section shall be used in the minimum amount
necessary to produce the intended effect.
(d) Sanitizing agents for use in accordance with this section will
bear labeling meeting the requirements of the Federal Insecticide,
Fungicide, and Rodenticide Act.
[42 FR 14609, Mar. 16, 1977]
Editorial Note: For Federal Register citations affecting
Sec. 178.1010, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.2010]
[Page 358-384]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart C--Antioxidants and Stabilizers
Sec. 178.2010 Antioxidants and/or stabilizers for polymers.
The substances listed in paragraph (b) of this section may be safely
used as antioxidants and/or stabilizers in polymers used in the
manufacture of articles or components of articles intended for use in
producing, manufacturing, packing, processing, preparing, treating,
packaging, transporting, or holding food, subject to the provisions of
this section:
(a) The quantity used shall not exceed the amount reasonably
required to accomplish the intended technical effect.
(b) List of substances:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
N-n-Alkyl-N'-(carboxymethyl)- For use only:
N,N'-trimethylenediglycine; the 1. As component of nonfood articles
alkyl group is even numbered in complying with Secs. 175.105 and
the range C14-C18 and the 177.2600 of this chapter.
nitrogen content is in the 2. At levels not to exceed 1.35
range 5.4-5.6 weight percent. percent by weight of natural rubber,
butadiene-acrylonitrile, butadiene-
acrylonitrile-styrene, and butadiene-
styrene polymers that are used in
contact with nonalcoholic food at
temperatures not to exceed room
temperature and that are employed in
closure-sealing gaskets complying
with Sec. 177.1210 of this chapter
or in coatings complying with Sec.
175.300, Sec. 176.170, or Sec.
175.320 of this chapter. The average
thickness of such coatings and
closure-sealing gaskets shall not
exceed 0.004 inch.
Alkylthiophenolics:............. For use only:
1. Acid-catalyzed condensation 1. At levels not to exceed 2 percent
reaction products of 4- by weight of adhesives complying with
nonylphenol, formaldehyde, and Sec. 175.105 of this chapter, of
1-dodecanethiol (CAS Reg. No. pressure-sensitive adhesives
164907-73-7).. complying with Sec. 175.125 of this
chapter, and of rubber articles
complying with Sec. 177.2600 of this
chapter.
2. Acid-catalyzed condensation 2. Do.
reaction products of branched 4-
nonylphenol, formaldehyde, and
1-dodecanethiol (CAS Reg. No.
203742-97-6)..
p-tert-Amylphenolformaldehyde For use only at levels not to exceed
resins produced when one mole 2.1 percent by weight of polyamide
of p-tert-amylphenol is made to resins that are:
react under acid conditions 1. Derived from dimerized vegetable
with one mole of formaldehyde. oil acids (containing not more than
20 percent of monomer acids) and
ethylenediamine.
2. Used in compliance with regulations
in parts 174, 175, 176, 177, 178 and
Sec. 179.45 of this chapter.
1,4-Benzenedicarboxylic acid, For use only at levels not to exceed
bis[2-(1,1-dimethylethyl)-6-[[3- 0.075 percent by weight of olefin
(1,1-dimethylethyl)-2-hydroxy-5- polymers complying with Sec.
methylphenyl]methyl]-4-methyl- 177.1520 of this chapter.
phenyl]ester (CAS Reg. No.
57569-40-1).
2-(2H-Benzotriazol-2-yl)-4,6- For use only:
bis(1-methyl-1- 1. At levels not to exceed 0.5 percent
phenylethyl)phenol (CAS Reg. by weight of polyethylene phthalate
No. 70321-86-7). polymers complying with Sec.
177.1630 of this chapter.
2. At levels not to exceed 3.0 percent
by weight of polycarbonate resins
complying with Sec. 177.1580 of this
chapter.
[[Page 359]]
2-(2H-Benzotriazol-2-yl)-4-(1, For use only at levels not to exceed
1, 3, 3-tetramethylbutyl) 0.5 percent by weight of
phenol (CAS Reg. No. 3147-75-9). polycarbonate resins complying with
Sec. 177.1580 of this chapter:
Provided, That the finished resins
contact food only under conditions of
use E, F, and G described in table 2
of Sec. 176.170(c) of this chapter.
2-[4,6-Bis(2,4-dimethylphenyl)- For use only:
1,3,5-triazin-2-yl]-5- 1. At levels not to exceed 0.3
(octyloxy)phenol (CAS Reg. No. percent by weight of olefin polymers
2725-22-6).. complying with Sec. 177.1520(c) of
this chapter in contact with food
types I, II, IV-B, VI, VII-B, and
VIII described in Sec. 176.170(c) of
this chapter, table 1, under
conditions of use D through G as
described in Sec. 176.170(c), table
2, of this chapter.
2. At levels not to exceed 0.1
percent by weight of polypropylene
complying with Sec. 177.1520(c) of
this chapter, items 1.1a, 1.2, and
1.3 in contact with food under
conditions of use A through H as
described in Sec. 176.170(c), table
2, of this chapter.
3. At levels not to exceed 0.04
percent by weight of polyethylene and
olefin copolymers complying with Sec.
177.1520(c) of this chapter, items
2.1, 2.2, 2.3, 3.1a, 3.1b, 3.1c,
3.2a, and 3.2b having a minimum
density of 0.94 gram per cubic
centimeter, in contact with food
under conditions of use A through H
as described in Sec. 176.170, table
2, of this chapter provided that the
finished articles used in contact
with fatty food types III, IV-A, V,
VII-A, and IX as described in table 1
of Sec. 176.170(c) of this chapter
hold a minimum of 2 gallons (7.6
liters) of food.
4. At levels not to exceed 0.4
percent by weight of ethylene
copolymers complying with Sec.
177.1520(c) of this chapter, items
3.1a, 3.1b, 3.1c, 3.2a, and 3.2b,
having a density of less than 0.94
gram per cubic centimeter, in contact
with food under conditions of use B
through H, as described in Sec.
176.170(c), table 2, of this chapter
provided that the finished articles
used in contact with fatty food types
III, IV-A, V, VII-A, and IX hold a
minimum of 5 gallons (18.9 liters) of
food.
5. At levels not to exceed 0.04
percent by weight of polyethylene
having a density of less than 0.94
gram per cubic centimeter, and olefin
polymers complying with Sec.
177.1520(c) of this chapter, items
2.1, 2.2, 2.3, 3.3a, 3.3b, 3.4, 3.5,
3.6, 4, 5, and 6, in contact with
food under conditions of use D
through G as described in Sec.
176.170(c) of this chapter, table 2,
provided that the finished articles
used in contact with fatty food types
III, IV-A, V, VII-A, and IX hold a
minimum of 5 gallons (18.9 liters) of
food.
[beta], 3(or 4)- For use only:
Bis(octadecylthio)cyclohexyleth 1. At levels not to exceed 0.3 percent
ane (CAS Reg. No. 37625-75-5); by weight of all polymers for use in
CAS synonym: 1-[(beta- contact with foods of Types I, II, IV-
(octadecylthio)ethyl]-3(or 4)- B, VI, VII-B, and VIII under
(octadecylthio)cyclohexane. conditions of use B through H as
described in tables 1 and 2 of Sec.
176.170(c) of this chapter.
2. At levels not to exceed 0.3 percent
by weight of polyolefins complying
with Sec. 177.1520 of this chapter,
for use in contact with food of types
III, IV-A, V, VII-A, and IX under
conditions of use C through G as
described in tables 1 and 2 of Sec.
176.170(c) of this chapter.
Bis(2,2,6,6-tetramethyl-4- For use only:
piperidinyl) sebacate (CAS Reg. 1. In adhesives complying with Sec.
No. 52829-07-9). 175.105 of this chapter.
2. At levels not to exceed 0.1 percent
by weight of pressure-sensitive
adhesives complying with Sec.
175.125 of this chapter.
[[Page 360]]
Bis(2,4-di-tert-butyl-6- For use only:
methylphenyl) ethyl phosphite 1. At levels not to exceed 0.3 percent
(CAS Reg. No. 145650-60-8). by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter. The finished polymers
may only be used with food of the
types identified in Sec. 176.170(c)
of this chapter, table 1, under
Categories I, II, IV-B, VI-A, VI-B,
VII-B, and VIII, and under conditions
of use B through H described in table
2 of Sec. 176.170(c) of this
chapter.
2. At levels not to exceed 0.1 percent
by weight of propylene polymers
complying with Sec. 177.1520(c) of
this chapter, items 1.1, 1.2, 1.3,
3.2b, 3.4, or 3.5, or 3.1a (where the
density of this polymer is at least
0.85 gram per cubic centimeter and
less than 0.91 gram per cubic
centimeter). The finished polymers
may only be used in contact with food
of the types identified in Sec.
176.170(c) of this chapter, table 1,
under Categories III, IV-A, V, VI-C,
VII-A, and IX, and under conditions
of use B through H described in table
2 of Sec. 176.170(c) of this
chapter.
3. At levels not to exceed 0.1 percent
by weight of high-density ethylene
polymers complying with Sec.
177.1520(c) of this chapter, items
2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, or
3.6 (where the density of each of
these polymers is at least 0.94 gram
per cubic centimeter), or 5. The
finished polymers may only be used in
contact with food of the types
identified in Sec. 176.170(c) of
this chapter, table 1, under
Categories III, IV-A, V, VI-C, VII-A,
and IX, and under conditions of use C
(maximum temperature 70 deg.C)
through G described in table 2 of
Sec. 176.170(c) of this chapter.
Provided, that the finished food
contact articles have a volume of at
least 18.9 liters (5 gallons).
4. At levels not to exceed 0.01
percent by weight of low-density
ethylene polymers complying with Sec.
177.1520(c) of this chapter, items
2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4,
3.5, or 3.6 (where the density of
each of these polymers is less than
0.94 gram per cubic centimeter). The
finished polymers may only be used in
contact with food of the types
identified in Sec. 176.170(c) of
this chapter, table 1, under
Categories III, IV-A, V, VI-C, VII-A,
and IX, and under conditions of use B
through H described in table 2 of
Sec. 176.170(c) of this chapter.
Provided, that the average thickness
of such polymers in the form in which
they contact food shall not exceed
0.001 inch.
1,2-Bis(3,5-di-tert-butyl-4- For use only:
hydroxyhydrocinnamoyl)- 1. As provided in Sec. 175.105 of
hydrazine (CAS Reg. No. 32687- this chapter.
78-8). 2. At levels not exceeding 0.1 percent
by weight of acrylonitrile-butadiene-
styrene copolymers used in accordance
with parts 175, 176, 177, and 181 of
this chapter.
3. At levels not exceeding 0.1 percent
by weight of polyoxymethylene
copolymers complying with Sec.
177.2470 of this chapter and of
polyoxymethylene homopolymers
complying with Sec. 177.2480 of this
chapter.
2,6-Bis(1-methylheptadecyl)-p- For use only at levels not exceeding
cresol. 0.3 percent by weight of olefin
polymers complying with Sec.
177.1520(c) of this chapter, items
1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1,
3.2, 3.3, or 4. The average thickness
of such polymers in the form in which
they contact fatty food or food
containing more than 8 percent of
alcohol shall not exceed 0.004 inch.
3,9-Bis[2,4-bis(1-methyl-1- For use only:
phenylethyl)phenoxy]-2,4,8,10- 1. At levels not to exceed 0.15
tetraoxa-3,9- percent by weight of all polymers,
diphosphaspiro[5.5]undecane except as specified below.
(CAS Reg. No. 154862-43-8), 2. At levels not to exceed 0.2 percent
which may contain not more than by weight of polycarbonate resins
2 percent by weight of complying with Sec. 177.1580 of this
triisopropanolamine (CAS Reg. chapter.
No. 122-20-3). 3. At levels not to exceed 0.3 percent
by weight of polyetherimide resins
complying with Sec. 177.1595 of this
chapter.
[[Page 361]]
5,7-Bis(1,1-dimethylethyl)-3- For use only:
hydroxy-2(3H)-benzofuranone, 1. At levels not to exceed 0.1 percent
reaction products with o-xylene by weight of olefin polymers
(CAS Reg. No. 181314-48-7). complying with Sec. 177.1520(c) of
this chapter. The finished polymers
may only be used in contact with food
of the types identified in Sec.
176.170(c) of this chapter, Table 1,
under Categories I, II, IV-B, VI-A,
VI-B, VII-B, and VIII, and under
conditions of use B through H
described in Table 2 of Sec.
176.170(c) of this chapter.
2. At levels not to exceed 0.02
percent by weight of:
(a) Propylene polymers and copolymers
complying with Sec. 177.1520(c) of
this chapter, items 1.1, 1.2, 3.1a,
3.2a, 3.2b, 3.4, or 3.5. The finished
polymer may only be used in contact
with food of types identified in Sec.
176.170(c) of this chapter, Table 1,
under Categories III, IV-A, V, VI-C,
VII-A, and IX, and under conditions
of use B through H described in Table
2 of Sec. 176.170(c) of this
chapter; or
(b) Ethylene polymers and copolymers
complying with Sec. 177.1520(c) of
this chapter, items 2.1, 2.2, 2.3,
3.1a, 3.1b, 3.2a, or 3.6 (where the
density of each of these polymers is
at least 0.94 gram per cubic
centimeter), or 5. The finished
polymers may only be used in contact
with food of the types identified in
Sec. 176.170(c) of this chapter,
Table 1, under Categories III, IV-A,
V, VI-C, VII-A, and IX, and under
conditions of use B through H
described in Table 2 of Sec.
176.170(c) of this chapter; provided
that the finished food-contact
articles have a volume of at least
18.9 liters (5 gallons).
3. At levels not to exceed 0.02
percent by weight of ethylene
polymers and copolymers complying
with Sec. 177.1520(c) of this
chapter, items 2.1, 2.2, 2.3, 3.1a,
3.1b, 3.2a, 3.4, 3.5, or 3.6 (where
the density of each of these polymers
is less than 0.94 gram per cubic
centimeter). The finished polymers
may only be used in contact with food
of the types identified in Sec.
176.170(c) of this chapter, Table 1,
under Categories III, IV-A, V, VI-C,
VII-A, and IX, and under conditions
of use B through H described in Table
2 of Sec. 176.170(c) of this
chapter; provided that the average
thickness of such polymers in the
form in which they contact food shall
not exceed 50 micrometers (0.002
inch).
3,9-Bis[2-{3-(3-tert-butyl-4- For use only:
hydroxy-5- 1. At levels not to exceed 0.2 percent
methylphenyl)propionyloxy{time} by weight of polypropylene complying
-1,1-dimethylethyl]-2,4,8,10- with Sec. 177.1520(c), item 1.1 of
tetraoxaspiro[5.5]undecane (CAS this chapter. The finished polymer is
Reg. No. 90498-90-1). to be used in contact with food only
under conditions of use D through H
described in table 2 of Sec.
176.170(c) of this chapter.
2. At levels not to exceed 0.3 percent
by weight of polyethylene complying
with Sec. 177.1520(c) of this
chapter, item 2.1, provided that the
polymer has a minimum density of 0.94
grams per cubic centimeter and is
used in contact with food only under
conditions of use D through G
described in table 2 of Sec.
176.170(c) of this chapter.
3. At levels not to exceed 0.3 percent
by weight of olefin polymers
complying with Sec. 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 propylene.
The finished polymer is to be used in
contact with food of types I, II, IV-
B, VI-A, VI-B, VI-C, VII-B, and VIII
under conditions of use A through H
described in tables 1 and 2 of Sec.
176.170(c) of this chapter.
[[Page 362]]
4-[[4,6-Bis(octylthio)-s-triazin- For use only:
2-yl]amino]-2,6-di-tert- 1. At levels not to exceed 0.5 percent
butylphenol (CAS Reg. No. 991- by weight: in styrene block
84-4). copolymers complying with Sec.
177.1810 of this chapter; in rosins
and rosin derivatives complying with
Sec. 175.300(b)(3)(v) of this
chapter; in can end cement
formulations complying with Sec.
175.300(b)(3)(xxxi) of this chapter;
in side seam cement formulations
complying with Sec.
175.300(b)(3)(xxxii) of this chapter;
in petroleum alicyclic hydrocarbon
resins and terpene resins complying
with Sec. 175.320(b)(3) of this
chapter; in rosin and rosin
derivatives complying with Sec.
176.170(a)(5) of this chapter; in
petroleum alicyclic hydrocarbon
resins or their hydrogenated products
complying with Sec. 176.170(b)(2) of
this chapter; in terpene resins
complying with Sec.
175.300(b)(2)(xi) of this chapter,
when such terpene resins are used in
accordance with Sec. 176.170(b)(1)
of this chapter; in resins and
polymers complying with Sec.
176.180(b) of this chapter; in
closures with sealing gaskets
complying with Sec. 177.1210 of this
chapter; in petroleum hydrocarbon
resin and rosins and rosin
derivatives complying with Sec.
178.3800(b) of this chapter; and in
reinforced wax complying with Sec.
178.3850 of this chapter.
2. At levels not to exceed 0.2 percent
by weight of the finished cellophane
complying with Sec. 177.1200 of this
chapter.
3. At levels not to exceed 0.1 percent
by weight in polystyrene and rubber-
modified polystyrene complying with
Sec. 177.1640 of this chapter:
Provided, That the finished
polystyrene and rubber-modified
polystyrene polymer contact food only
under conditions of use B through G
described in table 2 of Sec.
176.170(c) of this chapter.
4. In adhesives complying with Sec.
175.105 of this chapter; in pressure-
sensitive adhesives complying with
Sec. 175.125 of this chapter; and as
provided in Sec. 177.2600 of this
chapter.
4,4'-Bis([alpha],[alpha]- For use at levels not to exceed 0.3
dimethylbenzyl)diphenylamine percent by weight of polypropylene
(CAS Reg. No. 10081-67-1). complying with Sec. 177.1520(c) of
this chapter. The polypropylene
articles are limited to use in
contact with non-fatty foods only.
Boric acid (CAS Reg. No. 10043- For use only at levels not to exceed
35-3). 0.16 percent by weight of ethylene-
vinyl acetate-vinyl alcohol
copolymers complying with Sec.
177.1360(a)(3) and (d) of this
chapter.
1,3-Butanediol..................
Butylated reaction product of p- For use only:
cresol and dicyclopentadiene 1. As components of nonfood articles
produced by reacting p-cresol complying with Secs. 175.105 and
and dicyclopentadiene in an 177.2600(c)(4)(iii) of this chapter.
approximate mole ratio of 1.5 2. At levels not to exceed 1.0 percent
to 1, respectively, followed by by weight of acrylonitrile/butadiene/
alkylation with isobutylene so styrene copolymers. The finished
that the butyl content of the copolymers may be used in contact
final product is not less than with food of Types I, II, IV-B, VI-A,
18 percent. VI-B, VII-B, and VIII under
conditions of use B through H, as
described in tables 1 and 2 of Sec.
176.170(c) of this chapter, and with
food of Types III, IV-A, V, VI-C, VII-
A, and IX under conditions of use C
through G as described in tables 1
and 2 of Sec. 176. 170(c) of this
chapter.
Butylated, styrenated cresols For use only:
produced when equal moles of 1. As provided in Secs. 175.105 and
isobutylene, styrene, and a 177.2600 of this chapter.
metacresol-paracresol mixture 2. At levels not to exceed 0.5 percent
having a no more than 3 deg.C by weight of polystyrene, rubber-
distillation range including modified polystyrene, or olefin
202 deg.C are made to react so polymers complying with Sec.
that the final product meets 177.1520 (c) of this chapter, items
the following specifications: 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1,
Not less than 95 percent by 3.2, 3.3, or 4, or complying with
weight of total alkylated other sections in parts 174, 175,
phenols consisting of 13-25 176, 177, 178 and Sec. 179.45 of
percent by weight of butylated this chapter, used in articles that
m- and p-cresols, 26-38 percent contact food only unded the
by weight of styrenated m- and conditions described in Sec.
p-cresols, 37-49 percent by 176.170(c) of this chapter, table 2,
weight of butylated styrenated under conditions of use C through G.
m- and p-cresols, and not more
than 10 percent by weight total
of alkylated xylenols,
alkylated o-cresol, alkylated
phenol, and alkylated
ethylphenol; acidity not more
than 0.003 percent; and
refractive index at 25 deg.C
of 1.5550-1.5650, as determined
by ASTM method D1218-82,
"Standard Test Method for
Refractive Index and Refractive
Dispersion of Hydrocarbon
Liquids," which is
incorporated by reference.
Copies may be obtained from the
American Society for Testing
Materials, 1916 Race St.,
Philadelphia, PA 19103, or may
be examined at the Office of
the Federal Register, 800 North
Capitol Street, NW., suite 700,
Washington, DC 20408.
[[Page 363]]
2-tert-Butyl-a(3-tert-butyl-4- For use only:
hydroxyphenyl)-p-cumenyl bis(p- 1. As components of nonfood articles
nonylphenyl) phosphite; the complying with Secs. 175.105 and
nonyl group is a propylene 177.2600 of this chapter.
trimer isomer and the 2. At levels not to exceed 1.35
phosphorus content is in the percent by weight of natural rubber,
range 3.8-4.0 weight percent. butadiene-acrylonitrile, butadiene-
acrylonitrile-styrene, and butadiene-
styrene polymers that are used in
contact with nonalcoholic food at
temperatures not to exceed room
temperature and that are employed in
closure-sealing gaskets complying
with Sec. 177.1210 of this chapter
or in coatings complying with Sec.
175.300, Sec. 175.320, or Sec.
176.170 of this chapter. The average
thickness of such coatings and
closure-sealing gaskets shall not
exceed 0.004 inch.
2-(3'-tert-Butyl-2'-hydroxy-5'- For use only at levels not to exceed
methyl-phenyl)-5- 0.5 percent by weight of olefin
chlorobenzotriazole with a polymers complying with Sec.
melting point of 137-141 deg.C. 177.1520(c) of this chapter, provided
that the finished polymer contacts
foods only of the types identified in
Categories I, II, IV-B, VI-A and B,
VII-B, and VIII in table 1, Sec.
176.170 of this chapter.
4,4'-Butylidenebis(6-tert-butyl- For use only.
m-cresol). 1. As provided in Secs. 175.105 and
177.2600 of this chapter.
2. At levels not to exceed 0.5 percent
by weight of polypropylene complying
with Sec. 177.1520 of this chapter
and for use at levels not to exceed
0.3 percent by weight of polyethylene
complying with Sec. 177.1520 of this
chapter, provided that the finished
polypropylene and polyethylene
contact food only of the types
identified in Sec. 176.170(c) of
this chapter, table 1, under
Categories I, II, VI-B, and VIII.
Butyric acid, 3,3-bis(3-tert- For use only:
butyl-4-hydroxyphenyl)ethylene 1. At levels not to exceed 0.5 percent
ester (CAS Reg. No. 32509-66-3). by weight of olefin copolymers
complying with Sec. 177.1520(c) of
this chapter, items 3.1 and 3.2
except that when used in contact with
foods described as types III, IV-A,
V, VII-A, and IX in table 1 of Sec.
176.170(c) of this chapter, the
olefin copolymers may only be used
under conditions of use E, F, and G
set forth in table 2 of Sec.
176.170(c) of this chapter.
2. At levels not to exceed 0.5 percent
by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter, item 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 propylene).
3. At levels not to exceed 0.2 percent
by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter, items 2.1, 2.2, 3.1,
and 3.2.
Calcium benzoate................
[[Page 364]]
Calcium bis[monoethyl(3,5-di- For use only:
tert-butyl-4-hydroxy- 1. At levels not to exceed 0.25
benzyl)phosphonate] (CAS Reg. percent by weight of polypropylene
No. 65140-91-2). that complies with Sec. 177.1520(c)
of this chapter, items 1.1, 1.2, and
1.3.
2. At levels not to exceed 0.2 percent
by weight of polyethylene and olefin
copolymers that comply with Sec.
177.1520(c) of this chapter, items
2.1, 2.2, 2.3, 3.1, 3.2, 3.3, 3.4,
3.5, and 3.6. Finished polymers
having a density less than 0.94 gram
per cubic centimeter shall be used in
contact with food only under
conditions of use B through H
described in table 2 of Sec.
176.170(c) of this chapter.
3. In adhesives complying with Sec.
175.105 of this chapter.
4. At levels not to exceed 0.5 percent
by weight of pressure-sensitive
adhesives complying with Sec.
175.125 of this chapter.
5. At levels not to exceed 0.5 percent
by weight of rosins and rosin
derivatives complying with Sec.
175.300(b)(3)(v) of this chapter.
6. At levels not to exceed 0.5 percent
by weight of can end cement
formulations complying with Sec.
175.300(b)(3)(xxxi) of this chapter.
7. At levels not to exceed 0.5 percent
by weight of side seam cement
formulations complying with Sec.
175.300(b)(3)(xxxii) of this chapter.
8. At levels not to exceed 0.5 percent
by weight of petroleum alicyclic
hydrocarbon resins complying with
Sec. 175.320(b)(3) of this chapter.
9. At levels not to exceed 0.5 percent
by weight of rosin and rosin
derivatives complying with Sec.
176.170(a)(5) of this chapter; and
petroleum alicyclic hydrocarbon
resins, or the hydrogenated product
thereof, complying with Sec.
176.170(b)(2) of this chapter.
10. At levels not to exceed 0.5
percent by weight of resins and
polymers used as components of paper
and paperboard in contact with dry
food in compliance with Sec. 176.180
of this chapter.
11. At levels not to exceed 0.5
percent by weight of closures with
sealing gaskets complying with Sec.
177.1210 of this chapter.
12. At levels not to exceed 0.5
percent by weight of the finished
rubber article complying with Sec.
177.2600 of this chapter.
13. At levels not to exceed 0.5
percent by weight of petroleum
hydrocarbon resin and rosins and
rosin derivatives complying with Sec.
178.3800(b).
14. At levels not to exceed 0.5
percent by weight of reinforced wax
complying with Sec. 178.3850.
15. At levels not to exceed 0.3
percent by weight of polyethylene
phthalate polymers, complying with
Sec. 177.1630 of this chapter.
Provided, that the finished polymers
contact food only under conditions of
use B through H described in Table 2
of Sec. 176.170(c) of this chapter.
Calcium myristate...............
Calcium ricinoleate............. For use only at levels not to exceed 1
percent by weight of polyoxymethylene
copolymer as provided in Sec.
177.2470(b)(1) of this chapter.
Calcium stearate................
Carbethoxymethyl diethyl At levels not to exceed 0.07 percent
phosphonate (CAS Reg. No. 867- by weight of polyethylene phthalate
13-0). polymers complying with Sec.
177.1630 of this chapter.
Cerium stereate (CAS Reg. No. For use only at levels not to exceed
10119-53-6). 0.5 percent by weight in rigid and
semirigid vinyl chloride homo- and
copolymer articles modified in
accordance with Sec. 178.3790(b)(1)
of this chapter that contact food
under conditions of use B through H
described in table 2 of Sec.
176.170(c) of this chapter.
Cupric acetate and lithium For use at levels not exceeding 0.025
iodide. percent cupric acetate and 0.065
percent lithium iodide by weight of
nylon 66 resins complying with Sec.
177.1500 of this chapter; the
finished resins are used or are
intended to be used to contain foods
during oven baking or oven cooking at
temperatures above 250 deg.F. The
average thickness of such resins in
the form in which they contact food
shall not exceed 0.0012 inch.
Cuprous iodide.................. For use at levels not exceeding 0.01
percent cuprous iodide by weight of
nylon 66T resins complying with Sec.
177.1500 of this chapter; the
finished resins are used or are
intended to be used to contain foods
during oven baking or oven cooking at
temperatures above 250 deg.F. The
average thickness of such resins in
the form in which they contact food
shall not exceed 0.001 inch.
Cuprous iodide and cuprous For use at levels not exceeding 0.0025
bromide. percent cuprous iodide and 0.0175
percent cuprous bromide by weight of
nylon 66 resins complying with Sec.
177.1500 of this chapter; the
finished resins are used or are
intended to be used to contain foods
during oven baking or oven cooking at
temperatures above 250 deg.F. The
average thickness of such resins in
the form in which they contact food
shall not exceed 0.0015 inch.
Cyanoguanidine.................. For use only at levels not to exceed 1
percent by weight of polyoxymethylene
copolymer as provided in Sec.
177.2470(b)(1) of this chapter.
[[Page 365]]
Cyclic neopentanetetrayl For use only at levels not to exceed
bis(octadecyl phosphite) (CAS 0.1 percent by weight of ethylene-
Reg. No. 3806-34-6); the vinyl acetate copolymers complying
phosphorus content is in the with Sec. 177.1350 of this chapter
range of 7.8 to 8.2 weight that contact food under conditions of
percent. use E, F, and G described in table 2
of Sec. 176.170(c) of this chapter.
Cyclic neopentanetetrayl For use only:
bis(octadecyl phosphite) (CAS 1. At levels not to exceed 0.25
Reg. No. 3806-34-6) (which may percent by weight of olefin polymers
contain not more than 1 percent complying with Sec. 177.1520(c) of
by weight of this chapter, items 1.1, 2.1, and
triisopropanolamine (CAS Reg. 3.1.
No. 122-20-3)); the phosphorus 2. At levels not to exceed 0.25
content is in the range of 7.8 percent by weight of olefin polymers
to 8.2 weight percent. complying with Sec. 177.1520(c) of
this chapter, item 2.2, that contact
food Types I, II, VI-A, VII-B, and
VIII described in table 1 of Sec.
176.170(c) of this chapter under
conditions of use B (for boil-in-bag
applications), C, D, E, F, G, and H
described in table 2 of Sec.
176.170(c) of this chapter.
3. At levels not to exceed 0.15
percent by weight of olefin polymers
complying with Sec. 177.1520, items
1.1 and 3.2, that contact food Types
I, II, VI-A, VII-B, and VIII
described in table 1 of Sec.
176.170(c) of this chapter under
conditions of use B (for boil-in-bag
applications), C, D, E, F, G, and H
described in table 2 of Sec.
176.170(c) of this chapter.
4. At levels not to exceed 0.20
percent by weight of polystyrene and/
or rubber modified polystyrene
complying with Sec. 177.1640 of this
chapter that contact food under
conditions of use E, F, and G
described in table 2 of Sec.
176.170(c) of this chapter.
4,4'-Cyclohexylidenebis(2- For use only at levels not to exceed
cyclohexylphenol). 0.1 percent by weight of olefin
polymers complying with Sec.
177.1520(c) of this chapter, items
1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1,
3.2, 3.3, or 4: Provided, That the
finished polymers contact food only
of the types identified in Sec.
176.170(c) of this chapter, table 1,
under Categories I, II, IV-B, VI, VII-
B, and VIII.
Dicetyl thiodipropionate having The concentration of this additive and
a melting point of 59 deg.-62 any other permitted antioxidants in
deg.C as determined by ASTM the finished food-contact article
method E324-79, "Standard Test shall not exceed a total of 0.5
Method for Relative Initial and milligram per square inch of food-
Final Melting Points and the contact surface.
Melting Range of Organic
Chemicals," and a
saponification value in the
range 176-183 as determined by
ASTM method D1962-67
(Reapproved 1979), "Standard
Test Method for Saponification
Value of Drying Oils, Fatty
Acids, and Polymerized Fatty
Acids," which are incorporated
by reference. Copies may be
obtained from the American
Society for Testing Materials,
1916 Race St., Philadelphia, PA
19103, or may be examined at
the Office of the Federal
Register, 800 North Capitol
Street, NW., suite 700,
Washington, DC 20408.
Didodecyl- 1,4-dihydro-2,6- For use only at levels not to exceed
dimethyl-3,5- 0.3 percenmt by weight in rigid
pyridinedicarboxylate (CAS Reg. polymer articles modified in
No. 36265-41-5). accordance with Sec. 178.3790 that
contact food, under conditions of use
E, F, and G described in table 2 of
Sec. 176.170 of this chapter.
2,6-Di([alpha]-methyl benzyl)-4- For use only at levels not to exceed
methyl phenol [Chemical 0.2 percent by weight of olefin
Abstracts Service Registry No. polymers complying with item 3.4 in
1817-68-1]. Sec. 177.1520(c) of this chapter,
provided that such olefin polymers
are limited to use at a level not to
exceed 25 percent by weight in other
olefin polymers complying with Sec.
177.1520 of this chapter; and the
total amount in such finished olefin
polymers not to exceed 0.05 percent
by weight, including the level that
may be contributed by its presence at
6 percent in the item "butylated,
styrenated cresols * * * " listed in
this paragraph; and further provided
that the finished olefin polymers are
intended for contact with foods,
except those containing more than 8
percent alcohol.
2,4-Dimethyl-6-(1- For use only:
methylpentadecyl)phenol (CAS 1. At levels not to exceed 0.3 percent
Reg. No. 134701-20-5). by weight of acrylonitrile-butadiene-
styrene copolymers used in accordance
with applicable regulations in parts
175, 176, 177, and 181 of this
chapter, under conditions of use C
through H as described in table 2 of
Sec. 176.170(c) of this chapter.
2. At levels not to exceed 0.033
percent by weight of rigid polyvinyl
chloride, under conditions of use A
through H as described in table 2 of
Sec. 176.170(c) of this chapter.
Dimethyl succinate polymer with For use only:
4-hydroxy-2,2,6,6-tetramethyl-1- 1. At levels not to exceed 0.3 percent
piperidineethanol (CAS Reg. No. by weight of olefin polymers
65447-77-0). complying with Sec. 177.1520 of this
chapter and under conditions of use B
through H described in table 2 of
Sec. 176.170(c) of this chapter.
2. At levels not to exceed 0.3 percent
by weight of ethylene-vinyl acetate
copolymers complying with Sec.
177.1350 of this chapter and under
conditions of use B through H
described in table 2 of Sec.
176.170(c) of this chapter.
[[Page 366]]
Dimethyltin/monomethyltin For use only at levels not to exceed 2
isooctylmercaptoacetates percent by weight:
consisting of 5 to 90 percent 1. In rigid polyvinyl chloride used in
by weight of monomethyltin tris the manufacture of pipes intended for
(isooctylmercaptoacetate) (CAS contact with water in food-processing
Reg. No. 54849-38-6) or plants, and
monomethyltin tris(2- 2. In rigid polyvinyl chloride and in
ethylhexylmercaptoacetate) (CAS rigid vinyl chloride copolymers
Reg. No. 57583-34-3) and 10 to complying with Sec. 177.1950 of this
95 percent by weight of chapter or Sec. 177.1980 of this
dimethyltin bis chapter for use in contact with food
(isooctylmercaptoacetate) (CAS of Types I, II, III, IV (except
Reg. No. 26636-01-1) or liquid milk), V, VI, VII, VIII, and
dimethyltin bis(2- IX described in table 1 of Sec.
ethylhexylmercaptoacetate) (CAS 176.170(c) of this chapter under
Reg. No. 57583-35-4), and no conditions of use C through G
more than 0.4 percent by weight described in table 2 of Sec.
of trimethyltin compounds, and 176.170(c) of this chapter at
having the following temperatures not to exceed 88 deg.C
specifications: Tin content (as (190 deg.F).
Sn) in the range of 15 to 21
percent and mercaptosulfur
content in the range of 11 to
13.5 percent. Other alkyltin
compounds are not to exceed 20
ppm.
Dimyristyl thiodipropionate Finished food-contact articles
having a melting point of 48 containing this additive shall meet
deg.-52 deg.C as determined by the extractives limitations
ASTM method E324-79, "Standard prescribed in Sec. 176.170(c) of
Test Method for Relative this chapter.
Initial and Final Melting
Points and the Melting Range of
Organic Chemicals," and a
saponification equivalent in
the range 280-290 as determined
by ASTM method D1962-67
(Reapproved 1979), "Standard
Test Method for Saponification
Value of Drying Oils, Fatty
Acids, and Polymerized Fatty
Acids," which are incorporated
by reference. Copies may be
obtained from the American
Society for Testing Materials,
1916 Race St., Philadelphia PA
19103, or may be examined at
the Office of the Federal
Register, 800 North Capitol
Street, NW., suite 700,
Washington, DC 20408.
Di(n-octyl)tin bis(2-ethylhexyl For use only at levels not to exceed
maleate) [CAS Reg. No. 10039-33- 0.5 percent by weight of
5] having 12.5 to 15.0 percent acrylonitrile copolymers complying
by weight of tin (Sn) and with Secs. 177.1020 and 177.1030 of
having a saponification number this chapter and used in contact with
of 260 to 280. The additive is all food types under conditions of
made from di(n-octyl)tin oxide use C through G described in table 2
meeting the specifications of of Sec. 176.170(c) of this chapter.
Sec. 178.2650(a)(1).
N,N'-Diphenylthiourea........... For use only:
1. At levels not to exceed 0.5 percent
by weight of polyvinyl chloride and/
or vinyl chloride copolymers
complying with Sec. 177.1980 of this
chapter.
2. At levels not to exceed 0.5 percent
by weight of vinyl chloride-vinyl
acetate copolymers containing not
more than 20 molar percent of vinyl
acetate.
2-(4,6-Diphenyl-1,3,5-triazin-2- For use only
yl)-5-hexyloxy)phenol (CAS Reg. 1. At levels not to exceed 0.5 percent
No. 147315-50-2). by weight of polycarbonate resins
complying with Sec. 177.1580 of this
chapter.
2. At levels not to exceed 0.5 percent
by weight of polyester elastomers
complying with Sec. 177.1590 of this
chapter.
3. At levels not to exceed 0.5 percent
by weight of polyethylene phthalate
polymers complying with Sec.
177.1630 of this chapter, in contact
with food under conditions of use A
through H described in Table 2 of
Sec. 176.170(c) of this chapter.
2,6-Di-tert-butyl-4-ethylphenol. For use only in contact with
nonalcoholic foods:
1. At levels not exceeding 0.04 mg/in
\2\ of food contact surface and not
exceeding 0.1 percent by weight in
ethylene polymers and copolymers
complying with Sec. 177.1520(c) of
this chapter, items 2.1, 2.2, 2.3,
3.1, 3.2, and 3.3; Sec. 177.1340;
and Sec. 177.1350 of this chapter.
The average thickness of such
polymers and copolymers in the form
in which they contact food shall not
exceed 0.0025 in.
2. At levels not exceeding 0.04 mg/in
\2\ of food contact surface in
ethylene polymers and copolymers
complying with Sec. 177.1520(c) of
this chapter, items 2.1, 2.2, 2.3,
3.1, 3.2, and 3.3; Sec. 177.1340;
and Sec. 177.1350 of this chapter.
The average thickness of such
polymers and copolymers in the form
in which they contact food shall be
greater than 0.0025 in but shall not
exceed 0.025 in.
[[Page 367]]
3,5-Di-tert-butyl-4- For use only:
hydroxyhydrocinnamic acid 1. At levels not to exceed 0.5 percent
triester with 1,3,5-tris(2- by weight of polypropylene complying
hydroxyethyl)-s-triazine-2,4,6- with Sec. 177.1520 of this chapter
(1H,3H,5H)-trione (CAS Reg. No. in articles that contact food not in
34137-09-2). excess of high temperature heat-
sterilized condition of use A
described in Sec. 176.170(c) of this
chapter, table 2.
2. At levels not to exceed 0.5 percent
by weight of polyethylene complying
with Sec. 177.1520 of this chapter
in articles that contact food not in
excess of high temperature heat-
sterilized condition of use A
described in 176.170(c) of this
chapter, table 2.
3. In adhesives complying with Sec.
175.105 of this chapter.
4. At levels not to exceed 0.25
percent by weight of olefin
copolymers complying with Sec.
177.1520(c) of this chapter, items
3.1, 3.2, 3.3, 3.4, 3.5, and 4.0.
5. At levels not to exceed 2 percent
by weight of polyester elastomers,
complying with Sec. 177.1590 of this
chapter, in contact with dry food
only, and finished rubber articles
for repeated use, complying with Sec.
177.2600 of this chapter, in contact
with all foods, at temperatures not
to exceed 150 deg.F.
Di-tert-butyl-m-cresyl For use only:
phosphonite condensation 1. At levels not to exceed 0.1 percent
product with biphenyl (CAS Reg. by weight of olefin polymers
No. 178358-58-2) produced by complying with Sec. 177.1520(c) of
the condensation of 4,6-di-tert- this chapter, items 1.1, 2.1, 2.2,
butyl-m-cresol with the Friedel- 3.1(a), 3.1(b), 3.2(a), or 3.2(b).
Crafts addition product
(phosphorus trichloride and
biphenyl) so that the food
additive has a minimum
phosphorus content of 5.0
percent.
Di-tert-butylphenyl phosphonite For use only:
condensation product with 1. At levels not to exceed 0.1 percent
biphenyl (CAS Reg. No. 119345- by weight of olefin polymers
01-6) produced by the complying with Sec. 177.1520(c) of
condensation of 2,4-di-tert- this chapter, items 1.1, 1.2, 1.3,
butylphenol with the Friedel- 3.2b, 3.3a, 3.3b, 3.4, 3.5, and 3.1a
Crafts addition product (where the density is not less than
(phosphorus trichloride and 0.85 gram per cubic centimeter and
biphenyl) so that the food not more than 0.91 gram per cubic
additive has a minimum centimeter); and 2.1, 2.2, 2.3, 3.1a,
phosphorus content of 5.4 3.1b, 3.2a, and 3.6 (where the
percent, an acid value not density is not less than 0.94 gram
exceeding 10 mg KOH/gm, and a per cubic centimeter) and 5.
melting range of 85 deg.C to 2. At levels not to exceed 0.1 percent
110 deg.C (185 deg.F to 230 by weight of polycarbonate resins
deg.F). complying with Sec. 177.1580 of this
chapter.
3. At levels not to exceed 0.2 percent
by weight of polystyrene and 0.3
percent by weight of rubber-modified
polystyrene complying with Sec.
177.1640 of this chapter.
4. At levels not to exceed 0.15
percent by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter, items 2.1, 2.2, 2.3,
3.1a, 3.1b, 3.2a, 3.4, 3.5, and 3.6
(where the polyethylene component has
a density less than 0.94 gram per
cubic centimeter).
5. At levels not to exceed 0.1 percent
by weight of repeated use rubber
articles complying with Sec.
177.2600 of this chapter.
2,4-Di-tert-butylphenyl-3,5-di- For use only:
tert-butyl-4-hydroxy-benzoate 1. At levels not to exceed 0.6 percent
(CAS Reg. No. 4221-80-1). by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter, item 1.1: (1) when used
in single-use articles that contact
food of types I, II, IV-B, VI-A, VI-
B, VII-B, and VIII, identified in
table 1 of Sec. 176.170(c) of this
chapter; and (2) when used in
repeated-use articles that contact
food of types I, II, III, IV, V, VI,
VII, VIII, and IX identified in table
1 of Sec. 176.170(c) of this
chapter. The additive is used under
conditions of use B through H
described in table 2 of Sec.
176.170(c) of this chapter.
2. At levels not to exceed 0.25
percent by weight of olefin polymers
having a density of not less than
0.94 gram per cubic centimeter and
complying with Sec. 177.1520(c) of
this chapter, items 2.1, 2.2, 3.1,
and 3.2: (1) when used in single-use
articles that contact food of types
I, II, IV-B, VI-A, VI-B, VII-B, and
VIII, identified in table 1 of Sec.
176.170(c) of this chapter; and (2)
when used in repeated-use articles
that contact food of types I, II,
III, IV, V, VI, VII, VIII, and IX
identified in table 1 of Sec.
176.170(c) of this chapter. The
additive is used under conditions of
use B through H described in table 2
of Sec. 176.170(c) of this chapter.
[[Page 368]]
2,4-Di-tert-pentyl-6-[1-(3,5-di- For use only:
tert-pentyl-2- 1. At levels not to exceed 0.2 percent
hydroxyphenyl)ethyl]phenyl by weight of polypropylene complying
acrylate (CAS Reg. No. 123968- with Sec. 177.1520 of this chapter
25-2). in contact with food under conditions
of use D through G as described in
Table 2 of Sec. 176.170(c) of this
chapter, except that polypropylene
containing the additive at levels not
to exceed 0.075 percent by weight may
contact food under conditions of use
A through H described in Table 2 of
Sec. 176.170(c) of this chapter.
2. At levels not to exceed 1.0 percent
by weight of of styrene block
polymers complying with Sec.
177.1810 of this chapter. The
additive is used under conditions of
use D through G as described in Table
2 of Sec. 176.170(c) of this
chapter.
3. At levels not to exceed 1.0 percent
by weight of polystyrene and rubber
modified polystyrene complying with
Sec. 177.1640 of this chapter in
contact with food under conditions of
use D through G as described in Table
2 of Sec. 176.170(c) of this
chapter.
N,N[dprime]-1,2-Ethanediylbis[N- For use only:
[3-[[4,6-bis[butyl(1,2,2,6,6- 1. At levels not to exceed 0.06
pentamethyl-4- percent by weight of olefin polymers
piperidinyl)amino]-1,3,5- complying with Sec. 177.1520(c) of
triazin-2-yl]amino]propyl]- this chapter, items 1.1a, 1.1b, 1.2,
N',N"-dibutyl-N',N"- or 1.3. The finished polymers may
bis(1,2,2,6,6-pentamethyl-4- only be used in contact with food of
piperidinyl)-1,3,5-triazine- the Types III, IV-A, V, VI-C, VII-A,
2,4,6-triamine] (CAS Reg. No. and IX as described in table 1 of
106990-43-6). Sec. 176.170(c) of this chapter, and
under conditions of use A through H
as described in table 2 of Sec.
176.170(c) of this chapter.
2. At levels not to exceed 0.08
percent by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter. The finished polymers
may only be used in contact with food
of the Types I, II, IV-B, VI-A, VI-B,
VII-B, and VIII as described in table
1 of Sec. 176.170(c) of this
chapter, and under conditions of use
A through H as described in table 2
of Sec. 176.170(c) of this chapter.
Ethylenebis(oxyethylene)-bis-(3- 1. At levels not to exceed 0.3 percent
tert-butyl-4-hydroxy-5- by weight of polystyrene and/or
methylhydrocinnamate) (CAS Reg. rubber modified polystyrene polymers
No. 36443-68-2). complying with Sec. 177.1640 of this
chapter.
2. At levels not to exceed 0.3 percent
by weight of acrylonitrile-butadiene-
styrene copolymers used in accordance
with applicable regulations in parts
175, 176, 177, and 181 of this
chapter.
3. At levels not to exceed 0.75
percent by weight of polyoxymethylene
copolymers used in accordance with
Sec. 177.2470 of this chapter. The
finished articles shall not be used
for foods containing more than 15
percent alcohol.
4. At levels not to exceed 0.25
percent by weight of polyoxymethylene
homopolymers used in accordance with
Sec. 177.2480 of this chapter. The
finished articles shall not be used
for foods containing more than 15
percent alcohol.
5. At levels not to exceed 0.2 percent
by weight of rigid vinyl chloride
plastics prepared from vinyl chloride
homopolymers and/or vinly chloride
copolymers used in accordance with a
prior sanction or applicable
regulations in parts 175, 176, and
177 of this chapter. The vinyl
chloride copolymers shall contain not
less than 50 weight percent of total
polymer units derived from vinyl
chloride.
6. At levels not to exceed 0.1 percent
by weight of vinylidene chloride
homopolymers and/or vinylidene
chloride copolymers used in
accordance with a prior sanction or
applicable regulations in parts 175,
176, and 177 of this chapter. The
vinylidene chloride copolymers shall
contain not less than 50 weight
percent of total polymer units
derived from vinylidene chloride.
7. In adhesives used in accordance
with Sec. 175.105 of this chapter.
[[Page 369]]
2,2'-Ethylidenebis(4,6-di-tert- For use only:
butylphenol) (CAS Reg. No. 1. At levels not to exceed 0.1 percent
35958-30-6). by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter, item 1.1, 1.2, 1.3,
3.1, or 3.2 (where the polymers
complying with items 3.1 and 3.2
contain primarily polymer units
derived from propylene).
2. At levels not to exceed 0.05
percent by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter, item 2.1, 2.2, or 2.3.
The finished polymers are to be used
only under conditions of use B
through H described in table 2 of
Sec. 176.170(c) of this chapter.
3. At levels not to exceed 0.075
percent by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter, item 2.1, 2.2, or 2.3
(where the density of each of these
polymers is not less than 0.94 g/cc)
and item 3.1 or 3.2 (where each of
these polymers contains primarily
polymer units derived from ethylene).
4. At levels not to exceed 0.05
percent by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter, item 3.3, 3.4, 3.5, or
4.
5. At levels not to exceed 0.1 percent
by weight of ethylene vinyl acetate
copolymers complying with Sec.
177.1350 of this chapter and under
conditions of use C through G
described in table 2 of Sec.
176.170(c) of this chapter.
6. At levels not to exceed 0.1 percent
by weight of rigid or semirigid
polyvinyl chloride and under
conditions of use B through H
described in table 2 of Sec.
176.170(c) of this chapter.
7. At levels not to exceed 0.2 percent
by weight of acrylonitrile-butadiene-
styrene copolymers containing less
than 30 percent by weight of
acrylonitrile and under conditions of
use D through G described in table 2
of Sec. 176.170(c) of this chapter.
8. At levels not to exceed 0.1 percent
by weight of polystyrene complying
with Sec. 177.1640 of this chapter
and under conditions of use D through
G described in table 2 of Sec.
176.170(c) of this chapter.
9. At levels not to exceed 0.2 percent
by weight of rubber-modified
polystyrene complying with Sec.
177.1640 of this chapter.
10. In adhesives complying with Sec.
175.105 of this chapter.
[[Page 370]]
2,2'-Ethylidenebis(4,6-di-tert- For use only:
butylphenyl)fluorophosphonite 1. As provided in Sec. 175.105 of
(CAS Reg. No. 118337-09-0). this chapter.
2. In all polymers used in contact
with food of types I, II, IV-B, VI-A,
VI-B, VII-B, and VIII, under
conditions of use B through H
described in Tables 1 and 2 of Sec.
176.170(c) of this chapter at levels
not to exceed 0.25 percent by weight
of polymers.
3. In polypropylene complying with
Sec. 177.1520(c) of this chapter,
item 1.1, in contact with food of
types III, IV-A, V, VII-A, and IX,
under:
(a) Conditions of use B through H
described in Tables 1 and 2 of Sec.
176.170(c) of this chapter at levels
not to exceed 0.25 percent by weight
of the polymer; or
(b) Condition of use A, limited to
levels not to exceed 0.1 percent by
weight of the polymer; provided that
the food-contact surface has an
average thickness not exceeding 375
micrometers (0.015 inch).
4. In olefin copolymers complying with
Sec. 177.1520(c) of this chapter,
items 3.1a or 3.2a, and containing
not less than 85 percent by weight of
polymer units derived from propylene,
in contact with food of types III, IV-
A, V, VII-A, and IX, and under:
(a) Conditions of use C through G,
described in Tables 1 and 2 of Sec.
176.170(c) of this chapter, limited
to levels no greater than 0.2 percent
by weight of the copolymers; or
(b) Conditions of use A, B, and H,
limited to levels no greater than 0.1
percent by weight of the olefin
copolymers; provided that the food-
contact surface has an average
thickness not exceeding 375
micrometers (0.015 inch).
5. In olefin polymers complying with
Sec. 177.1520(c) of this chapter,
items 1.2 or 1.3 in contact with food
of types III, IV-A, V, VII-A, and IX,
under conditions of use A through H,
described in Tables 1 and 2 of Sec.
176.170(c) of this chapter at levels
not to exceed 0.1 percent by weight
of the polymers; provided that the
food-contact surface has an average
thickness not exceeding 375
micrometers (0.015 inch).
6. In polyethylene complying with Sec.
177.1520(c) of this chapter, items
2.1 or 2.2, having a density of not
less than 0.94, in contact with food
of types III, IV-A, V, VII-A, and IX,
and under:
(a) Conditions of use B through H,
described in Tables 1 and 2 of Sec.
176.170(c) of this chapter limited to
levels not to exceed 0.2 percent by
weight of the polymers; or
(b) Condition of use A, described in
Tables 1 and 2 of Sec. 176.170(c) of
this chapter, limited to levels not
to exceed 0.1 percent by weight of
the polymer; provided that the food-
contact surface has an average
thickness not exceeding 125
micrometers (0.005 inch).
7. In olefin copolymers complying with
Sec. 177.1520(c) of this chapter,
items 3.1a, 3.1b, 3.2a, or 3.2b,
containing not less than 85 percent
by weight of polymer units derived
from ethylene and having a density of
not less than 0.94, in contact with
food of types III, IV-A, V, VII-A,
and IX, and under:
(a) Conditions of use C through G,
described in Tables 1 and 2 of Sec.
176.170(c) of this chapter limited to
levels not to exceed 0.2 percent by
weight of the copolymers; or
(b) Conditions of use A, B, and H,
limited to levels not to exceed 0.1
percent by weight of the copolymers;
provided that the food-contact
surface has an average thickness not
exceeding 125 micrometers (0.005
inch).
8. In olefin polymers complying with
Sec. 177.1520(c) of this chapter,
items 3.1a, 3.1b, 3.2a, or 3.2b
containing not less than 85 percent
by weight of polymer units derived
from ethylene, in contact with food
of types III, IV-A, V, VII-A, and IX,
under conditions of use A through H,
as described in Tables 1 and 2 of
Sec. 176.170(c) of this chapter at
levels not to exceed 0.1 percent by
weight of the copolymer; provided
that the food-contact surface has an
average thickness not exceeding 75
micrometers (0.003 inch).
9. In polyethylene phthalate polymers
complying with Sec. 177.1630 of this
chapter in contact with food of types
III, IV-A, V, VI-C, VII-A, and IX,
and under:
(a) Conditions of use B through H,
described in tables 1 and 2 of Sec.
176.170(c) of this chapter, limited
to levels not to exceed 0.3 percent
by weight of the polymers; or
(b) Condition of use A with food of
types III, IV-A, V, VII-A, and IX,
and limited to levels not to exceed
0.1 percent by weight of the
polymers; provided that the film
thickness does not exceed 875
micrometers (0.035 inch).
Hexadecyl 3,5-di-tert-butyl-4- For use only at levels not to exceed
hydroxybenzoate (CAS Reg. No. 0.5 percent by weight of olefin
67845-93-6). polymers complying with Sec.
177.1520 of this chapter.
[[Page 371]]
Hexamethylenebis (3,5-di-tert- For use only:
butyl-4-hydroxyhydrocinnamate) 1. As provided in Sec. 177.2470(b)(1)
(CAS Reg. No. 35074-77-2). and Sec. 177.2480(b)(1) of this
chapter.
2. In adhesives complying with Sec.
175.105 of this chapter.
3. At levels not to exceed 1 percent
by weight in pressure-sensitive
adhesives complying with Sec.
175.125 of this chapter.
4. At levels not to exceed 1 percent
by weight in can end cement
formulations complying with Sec.
175.300(b)(3)(xxxi) of this chapter.
5. At levels not to exceed 1 percent
by weight in side seam cement
formulations complying with Sec.
175.300(b)(3)(xxxii) of this chapter.
6. At levels not to exceed 1 percent
by weight in petroleum alicyclic
hydrocarbon resins, polyamide resins,
and terpene resins complying with
Sec. 175.320 of this chapter.
7. At levels not to exceed 1 percent
by weight in rosin and rosin
derivatives when used in accordance
with Sec. 176.170(a)(5) of this
chapter.
8. At levels not to exceed 1 percent
by weight in petroleum alicyclic
hydrocarbon resins or their
hydrogenated products complying with
Sec. 176.170(b)(2) of this chapter.
9. At levels not to exceed 1 percent
by weight in terpene resins complying
with Sec. 175.300(b)(3)(xi) of this
chapter, when such terpene resins are
used in accordance with Sec.
176.170(b)(1) of this chapter.
10. At levels not to exceed 1 percent
by weight in resins and polymers
authorized for use in accordance with
Sec. 176.180 of this chapter.
11. At levels not to exceed 1 percent
by weight in closures with sealing
gaskets complying with Sec. 177.1210
of this chapter.
12. At levels not to exceed 1 percent
by weight in rubber articles intended
for repeated use complying with Sec.
177.2600 of this chapter.
13. At levels not to exceed 1 percent
by weight in petroleum hydrocarbon
resin and rosins and rosin
derivatives used in accordance with
Sec. 178.3800 of this chapter.
14. At levels not to exceed 1 percent
by weight in reinforced wax complying
with Sec. 178.3850 of this chapter.
N,N'-Hexamethylenebis (3,5-di- For use only:
tert-butyl-4- 1. At levels not to exceed 1 percent
hydroxyhydrocinnamamide) (CAS by weight of nylon resins complying
Reg. No. 23128-74-7). with Sec. 177.1500(b) of this
chapter, items 1 through 8, that
contact food only of the types
identified in categories in Sec.
176.170(c) of this chapter, table 1
except VI-A and VI-C.
2. At levels not to exceed 0.75
percent by weight of nylon 12 resins
complying with Sec. 177.1500(b) of
this chapter, item 9, that contact
food only of the types identified in
categories in Sec. 176.170(c) of
this chapter, table 1, except VI-A
and VI-C.
3. At levels not to exceed 0.6 percent
by weight of polyester resins
complying with Sec.
175.300(b)(3)(vii) of this chapter.
4. At levels not to exceed 0.6 percent
by weight of closures with sealing
gaskets complying with Sec. 177.1210
of this chapter.
5. At levels not to exceed 0.6 percent
by weight of repeated use rubber
articles complying with Sec.
177.2600 of this chapter.
6. At levels not to exceed 0.5
percent by weight of polyoxymethylene
copolymer complying with Sec.
177.2470 of this chapter.
7. At levels not to exceed 0.5
percent by weight of polyoxymethylene
homopolymer complying with Sec.
177.2480 of this chapter.
1,6-Hexanediamine, N, N'- For use only as a stabilizer at levels
bis(2,2,6,6-tetramethyl-4- not to exceed 0.3 percent by weight
piperidinyl)-, polymers with of olefin polymers complying with
morpholine-2,4,6-trichloro- Sec. 177.1520(c) of this chapter.
1,3,5-triazine reaction The finished polymers are to contact
products, methylated (CAS Reg. food only under conditions of use C,
No. 193098-40-7). D, E, F, and G, as described in Table
2 of Sec. 176.170(c) of this
chapter. Provided that the finished
food-contact articles have a volume
of at least 18.9 liters (5 gallons).
[[Page 372]]
1,6-Hexanediamine, N,N'- For use only:
bis(2,2,6,6-tetramethyl-4- 1. At levels not to exceed 0.5 percent
piperidinyl)-, polymer with by weight of propylene polymers and
2,4,6-trichloro-1,3,5-triazine, copolymers complying with Sec.
reaction products with N-butyl- 177.1520(c) of this chapter, items
1-butanamine and N-butyl- 1.1, 1.2, 3.1a, 3.2a, 3.2b, 3.4, or
2,2,6,6-tetramethyl-4- 3.5. The finished polymers may
piperidinamine (CAS Reg. No. contact food only of the types
192268-64-7). identified in Sec. 176.170(c) of
this chapter, table 1, under
categories I, II, IV-B, VI-A, VI-B,
VII-B, and VIII, and under conditions
of use B through H described in table
2 of Sec. 176.170(c) of this
chapter.
2. At levels not to exceed 0.3 percent
by weight of propylene polymers and
copolymers complying with Sec.
177.1520(c) of this chapter, items
1.1, 1.2, 3.1a, 3.2a, 3.2b, 3.4, or
3.5. The finished polymers may
contact food only of the types
identified in Sec. 176.170(c) of
this chapter, table 1, under
categories III, IV-A, V, VI-C, VII-A,
and IX, and under conditions of use B
through H described in table 2 of
Sec. 176.170(c) of this chapter.
3. At levels not to exceed 0.5 percent
by weight of ethylene polymers and
copolymers complying with Sec.
177.1520(c) of this chapter, items
2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, or
3.6 (where the density of each of
these polymers is at least 0.94 gram
per cubic centimeter), or 5. The
finished polymers may contact food
only of the types identified in Sec.
176.170(c) of this chapter, table 1,
under categories I, II, IV-B, VI-A,
VI-B, VII-B, and VIII, and under
conditions of use B through H
described in table 2 of Sec.
176.170(c) of this chapter.
4. At levels not to exceed 0.05
percent by weight of ethylene
polymers and copolymers complying
with Sec. 177.1520(c) of this
chapter, items 2.1, 2.2, 2.3, 3.1a,
3.1b, 3.2a, or 3.6 (where the density
of each of these polymers is at least
0.94 gram per cubic centimeter), or
5. The finished polymers may contact
food only of the types identified in
Sec. 176.170(c) of this chapter,
table 1, under categories III, IV-A,
V, VI-C, VII-A, and IX, and under
conditions of use B through H
described in table 2 of Sec.
176.170(c) of this chapter.
5. At levels not to exceed 0.5 percent
by weight of ethylene polymers and
copolymers complying with Sec.
177.1520(c) of this chapter, items
2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4,
3.5, or 3.6 (where the density of
each of these polymers is less than
0.94 gram per cubic centimeter), or
5. The finished polymers may contact
food only of the types identified in
Sec. 176.170(c) of this chapter,
table 1, under categories I, II, IV-
B, VI-A, VI-B, VII-B, and VIII, and
under conditions of use C through G
described in table 2 of Sec.
176.170(c) of this chapter.
6. At levels not to exceed 0.01
percent by weight of ethylene
polymers and copolymers complying
with Sec. 177.1520(c) of this
chapter, items 2.1, 2.2, 2.3, 3.1a,
3.1b, 3.2a, 3.4, 3.5, or 3.6 (where
the density of each of these polymers
is less than 0.94 gram per cubic
centimeter), or 5. The finished
polymers may contact food only of the
types identified in Sec. 176.170(c)
of this chapter, table 1, under
categories III, IV-A, V, VI-C, VII-A,
and IX, and under conditions of use C
through G described in table 2 of
Sec. 176.170(c) of this chapter.
2-Hydroxy-4-isooctoxy- For use only at levels not to exceed
benzophenone. Chemical 0.5 percent by weight of olefin
Abstracts (CA) name: Methanone, copolymers complying with Sec.
[2-hydroxy-4-(isooctyloxy) 177.1520(c) of this chapter: Items
phenyl]phenyl; CA Registry No. 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1,
330:59-05-1. 3.2, 3.3 or 4: Provided, That the
finished polymer contacts food only
of the types identified in Sec.
176.170(c) of this chapter, table 1,
under Categories I, VII-B and VIII
under conditions of use E, F, and G
described in table 2 of Sec.
176.170(c) of this chapter.
[[Page 373]]
2(2'-Hydroxy-5'- For use only:
methylphenyl)benzotriazole 1. As component of nonfood articles
meeting the following complying with Sec. 177.1010 of this
specification: melting point chapter.
126 deg. -132 deg.C (258.8 2. At levels not to exceed 0.25
deg. -269.6 deg.F) (CAS Reg. percent by weight of rigid polyvinyl
No. 2440-22-4). chloride and/or rigid vinyl chloride
copolymers complying with Sec.
177.1980 of this chapter.
3. In polystyrene that complies with
Sec. 177.1640 of this chapter and
that is limited to use in contact
with dry food of Type VIII described
in table 1 of Sec. 176.170(c) of
this chapter.
4. At levels not to exceed 0.25
percent by weight of polystyrene and/
or rubber-modified polystyrene
polymers complying with Sec.
177.1640 of this chapter intended to
contact nonalcoholic food: Provided,
That the finished basic rubber-
modified polystyrene polymers in
contact with fatty foods shall
contain not less than 90 weight
percent of total polymer units
derived from styrene monomer.
5. At levels not to exceed 0.5 percent
by weight of polycarbonate resins
complying with Sec. 177.1580 of this
chapter. Provided, That the finished
polycarbonate resins contact food
only of Types I, II, III, IV, V, VI-
A, VI-B, VII, VIII, and IX identified
in table 1 of Sec. 176.170(c) of
this chapter and under conditions of
use E, F, and G described in table 2
of Sec. 176.170(c) of this chapter.
6. At levels not to exceed 0.5 percent
by weight of ethylene-1,4-
cyclohexylene dimethylene
terephthalate copolymers complying
with Sec. 177.1315 of this chapter
and of ethylene phthalate polymers
complying with Sec. 177.1630 of this
chapter and that contact food only
under conditions of use D through G
described in table 2, Sec.
176.170(c) of this chapter.
2-Hydroxy-4-n-octoxy- For use only at levels not to exceed
benzophenone. 0.5 percent by weight of olefin
polymers complying with Sec.
177.1520(c) of this chapter, items
1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1,
3.2, 3.3, or 4: Provided, That the
finished polymer contacts food only
of the types identified in Sec.
176.170(c) of this chapter, table 1,
under Categories I, IV-B, VII-B, and
VIII , and under the conditions of
use B through H described in table 2
of Sec. 176.170(c) of this chapter.
4,4'-Isopropylidenediphenol For use only at levels not exceeding
alkyl(C12-C15) phosphites; the 1.0 percent by weight in rigid
phosphorus content is in the polyvinyl chloride and/or rigid vinyl
range of 5.2-5.6 weight percent. chloride copolymers complying with
Secs. 177.1950, 177.1970 or 177.1980
of this chapter, and used in contact
with food, except milk, only under
the conditions described in Sec.
176.170(c) of this chapter, table 2,
under conditions of use D through G.
Magnesium salicylate............ For use only in rigid polyvinyl
chloride and/or in rigid vinyl
chloride copolymers complying with
Sec. 177.1980 of this chapter:
Provided, That total salicylates
(calculated as the acid) do not
exceed 0.3 percent by weight of such
polymers.
2-Methyl-4,6-bis- For use only:
[(octylthio)methyl] phenol (CAS 1. In adhesives complying with Sec.
Reg. No. 110553-27-0). 175.105 of this chapter.
2. At levels not to exceed 0.5 percent
by weight of can-end cements and side-
seam cements complying with Sec.
175.300(b)(xxxi) and (xxxii) of this
chapter.
3. At levels not to exceed 1 percent
by weight of pressure sensitive
adhesives complying with Sec.
175.125 of this chapter petrolium
alicyclic hydrocarbon resins
complying with Sec. 176.170 of this
chapter, resins and polymers
complying with Sec. 176.180 of this
chapter, and closures with sealing
gaskets complying with Sec. 177.1210
of this chapter.
4. At levels not to exceed 1.7 percent
by weight of the finished rubber
products complying with Sec.
177.2600 of this chapter.
5. At levels not to exceed 0.1 percent
by weight of petroleum alicyclic
hydrocarbon resins complying with
Sec. 175.320 of this chapter; rubber-
modified polystyrene complying with
Sec. 177.1640 of this chapter; and
petroleum hydrocarbon resins and
rosins and rosins and rosin
derivatives complying with Sec.
178.3800 of this chapter.
6. At levels not to exceed 0.2 percent
by weight of styrene block polymenrs
complying with Sec. 177.1810 of this
chapter that contact food of Types I,
II, IV-B, VI, VII-B, and VIII
described in table 1, Sec.
176.170(c) of this chapter, only
under conditions of use C through H
described in table 2, Sec.
176.170(c) of this chapter.
[[Page 374]]
2,2'-Methylenebis(4,6-di-tert- For use only at levels not to exceed
butylphenyl)2-ethylhexyl 0.25 percent by weight of
phosphite (CAS Reg. No. 126050- polypropylene complying with Sec.
54-2). 177.1520 of this chapter. The
finished polymers may only be used in
contact with food of the types
identified in Sec. 176.170(c) of
this chapter, table 1, under
Categories I, II, IV-B, VI-B, VII-B,
and VIII under conditions of use B
through H described in table 2, Sec.
176.170(c) of this chapter, and with
food of the types identified in Sec.
176.170(c) of this chapter, table 1,
under Categories III, IV-A, V, VI-A,
VI-C, VII-A, and IX under conditions
of use C through G described in table
2, Sec. 176.170(c) of this chapter.
2,2'-Methylenebis (6-tert-butyl- For use only:
4-ethylphenol). 1. In acrylonitrile-butadiene-styrene
copolymers at levels not to exceed
0.6 percent by weight of the
copolymer.
2. In semirigid and rigid acrylic and
modified acrylic plastics complying
with Sec. 177.1010 of this chapter
at levels not to exceed 0.1 percent
by weight of the plastic.
4,4'-Methylenebis (2,6-di-tert- For use only:
butyl-phenol). 1. As provided in Sec. 175.105 of
this chapter.
2. At levels not to exceed 0.25
percent by weight of petroleum
hydrocarbon resins used in compliance
with regulations in parts 174, 175,
176, 177, 178 and Sec. 179.45 of
this chapter.
3. At levels not to exceed 0.25
percent by weight of terpene resins
used in compliance with regulations
in parts 174, 175, 176, 177, 178 and
Sec. 179.45 of this chapter.
4. At levels not to exceed 0.5 percent
by weight of polyethylene complying
with Sec. 177.1520 of this chapter:
Provided, That the polyethylene end
product contacts foods only of the
types identified in Categories I, II,
IV-B, VI, VII-B, and VIII in table 1,
Sec. 176.170(c) of this chapter.
5. At levels not to exceed 0.5 percent
by weight of polybutadiene used in
rubber articles complying with Sec.
177.2600 of this chapter: Provided,
That the rubber end product contacts
foods only of the types identified in
Categories I, II, IV-B, VI, VII-B,
and VIII in table 1, Sec. 176.170(c)
of this chapter.
2,2'-Methylenebis(4-methyl-6- For use only:
tert-butylphenol). 1. At levels not to exceed 0.1 percent
by weight of olefin polymers
complying with sec. 177.1520(c) of
this chapter, items 1.1, 1.2, 1.3,
2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4
used in articles that contact food of
the types identified in sec.
176.170(c) of this chapter, table 1,
under Categories I, II, IV-B, VI, VII-
B, and VIII.
2. At levels not to exceed 1 percent
by weight of polyoxymethylene
copolymer as provided in sec.
177.2470(b)(1) of this chapter.
3. At levels not to exceed 0.5 percent
by weight of polyoxymethylene
homopolymer as provided in Sec.
177.2480(b)(1) of this chapter.
2,2'-Methylenebis(4-methyl-6- For use only:
tert-butylphenol) monoacrylate 1. At levels not to exceed 0.5 percent
(CAS Reg. No. 61167-58-6). by weight of polystyrene and rubber-
modified polystyrene complying with
Sec. 177.1640 of this chapter.
2. At levels not to exceed 0.5 percent
by weight of styrene block ploymers
complying with Sec. 177.1810 of this
chapter.
3. At levels not to exceed 1 percent
by weight of adhesives complying with
Sec. 175.105 of this chapter and
pressure sensitive adhesives
complying with Sec. 175.125 of this
chapter.
4. At levels not to exceed 0.5 percent
by weight of acrylonitrile-butadiene-
styrene copolymers that comply with
Sec. 177.1020 of this chapter when
used in articles that contact food
only under conditions of use E, F,
and G as described in table 2, Sec.
176.170 (c) of this chapter.
2,2'-Methylenebis[6-(1- For use only:
methylcyclo-hexyl)-p-cresol]. 1. As provided in Sec. 177.1210 of
this chapter.
2. At levels not to exceed 0.2 percent
by weight of polyethylene complying
with Sec. 177.1520 of this chapter:
Provided, That the finished
polyethylene contacts foods only of
the type identified in Sec.
176.170(c) of this chapter, table 1,
under Categories I, II, VI-B, and
VIII.
3. In polyethylene complying with Sec.
177.1520 of this chapter: Provided,
That the finished polyethylene
contacts foods only of the types
identified in Sec. 176.170(c) of
this chapter, table 1, under
Categories III, IV, V, VI-A, VII, and
IX, and only at temperatures not to
exceed room temperature: And further
provided, That percentage
concentration of the antioxidant in
the polyethylene, when multiplied by
the thickness in inches of the
finished polyethylene, shall not be
greater than 0.0005.
2,2'-Methylenebis(4-methyl-6- For use only in acrylonitrile-
nonylphenol) and 2,6-bis(2- butadiene-styrene copolymers used in
hydroxy-3-nonyl-5-methyl- contact with nonalcoholic foods.
benzyl)-p-cresol mixtures
(varying proportions).
[[Page 375]]
Methyltin-2-mercaptoethyloleate For use only in rigid poly(vinyl
sulfide, which is defined as chloride) and rigid vinyl chloride
one or more of the following: copolymers complying with Secs.
177.1950 and 177.1980 of this
chapter, respectively, used in the
manufacture of pipes and pipe
fittings intended for contact with
water in food processing plants, at
levels not to exceed:
1. 1.0 percent by weight in pipes, and
2. 2.0 percent by weight in pipe
fittings.
1. 9-Octadecenoic acid (Z)-, 2-
mercaptoethyl ester, reaction
products with dichlorodime
thylstannane, sodium sulfide,
and trichloromethylstannane
(CAS Reg. No. 68442-12-6);
2. Fatty acids, tall oil, 2-
mercaptoethyl esters,
reaction products with
dichlorodimethylstannane, 2-
mercaptoethyl decanoate, 2-
mercaptoethyl octanoate,
sodium sulfide, and
trichloromethylstannane (CAS
Reg. No. 151436-98-5); or
3. Fatty acids, tall oil, 2-
mercaptoethyl esters,
reaction products with
dichlorodimethylstannane,
sodium sulfide, and
trichloromethylstannane (CAS
Reg. No. 201687-57-2);and
which has the following
specifications: Tin content
(as Sn) 5 to 21 percent by
weight; mercaptosulfur
content 5 to 13 percent by
weight; acid value no greater
than 4.
Methyltin-2-
Mercaptoethyloleate sulfide
may also be used with one or
more of the following
optional substances:
1.1a 2-Mercaptoethyl oleate
(CAS Reg. No. 59118-78-4),
1.1b 2-Mercaptoethyl tallate
(CAS Reg. No. 68440-24-4),
1.1c 2-Mercaptoethyl octanoate
(CAS Reg. No. 57813-59-9),
1.1d 2-Mercaptoethyl decanoate
(CAS Reg. No. 68928-33-6),
alone or in combination; not
to exceed 40 percent by
weight of the stabilizer
formulation;
2.1 2-Mercaptoethanol (CAS
Reg. No. 60-24-2): Not to
exceed 2 percent by weight of
the stabilizer formulation.
3.1 Mineral oil (CAS Reg. No.
8012-95-1): Not to exceed 40
percent by weight of the
stabilizer formulation.
4.1 Butylated hydroxytoluene
(CAS Reg. No. 128-37-0): Not
to exceed 5 percent by weight
of the stabilizer
formulation.
The total of the optional
substances (1.1a through 4.1)
shall not exceed 60 percent
by weight of the stabilizer
formulation.
Nylon 66/610/6 terpolymer (see For use only at levels not to exceed
Sec. 177.1500 of this chapter 1.5 percent by weight of
for identification) polyoxymethylene homopolymer as
provided in Sec. 177.2480 (b)(1) of
this chapter.
Nylon 612/6 copolymer. (CAS Reg. For use only at levels not to exceed
No. 51733-10-9), weight ratio 6/ 1.5 percent by weight of
1. polyoxymethylene homopolymer as
provided in Sec. 177.2480(b)(1).
[[Page 376]]
Octadecyl 3,5-di-tert-butyl-4- For use only:
hydroxyhydrocinnamate (CAS Reg. 1. At levels not exceeding 0.25
No. 2082-79-3). percent by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter, item 1.1, 1.2, 1.3,
2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4.
2. As provided in Secs. 175.105 and
177.1010(a)(5) of this chapter.
3. At levels not exceeding 0.25
percent by weight of polystyrene and/
or rubber-modified polystyrene
polymers complying with Sec.
177.1640 of this chapter, except that
the finished basic rubber-modified
polystyrene polymers in contact with
fatty foods shall contain not less
than 85 weight percent of total
polymer units derived from styrene
monomer.
4. At levels not to exceed 0.5 percent
by weight of acrylonitrile-butadiene-
styrene copolymers used in accordance
with prior sanction or regulations in
parts 174, 175, 176, 177, 178 and
Sec. 179.45 of this chapter.
5. At levels not exceeding 0.25
percent by weight of olefin
copolymers complying with Sec.
177.1520(c) of this chapter, items
3.4 and 3.5 as follows: (a) item 3.4,
Provided, That the finished copolymer
contacts foods only of types
identified in Sec. 176.170(c) of
this chapter, table 1, under
Categories I, II, III, IV-B, VI, VII,
VIII, and IX; (b) item 3.5, Provided,
That the finished copolymer contacts
non-fatty foods only of types
identified in Sec. 176.170(c) of
this chapter, table 1, under
Categories I, II, IV-B, VI, VII-B,
and VIII.
6. At levels not exceeding 0.05
percent by weight of modified semi-
rigid and rigid vinyl chloride
plastics modified with methacrylate-
butadiene-styrene copolymers in
accordance with Sec. 178.3790.
7. At levels not exceeding 0.2 percent
by weight of rigid polyvinyl
chloride.
8. At levels not to exceed 0.3 percent
by weight of polycarbonate resins
that comply with Sec. 177.1580 and
that contact food only under
conditions of use E, F, and G
described in table 2, Sec.
176.170(c) of this chapter.
9. At levels not exceeding 0.1 percent
by weight of ethylene-vinyl acetate
copolymers complying with Sec.
177.1350 of this chapter.
10. At levels not to exceed 0.2
percent by weight of nitrile rubber-
modified acrylonitrile-methyl
acrylate copolymers that comply with
Sec. 177.1480 of this chapter when
used in articles that contact food
only under conditions of use D, E, F,
and G described in table 2, Sec.
176.170(c) of this chapter.
11. At levels not exceeding 0.3
percent by weight of styrene block
polymers complying with Sec.
177.1810 of this chapter when used in
articles that contact food only of
the types identified in Sec.
176.170(c) of this chapter, table 1,
under Categories I, II, IV-B, VI, VII-
B, and VIII, and under conditions of
use D, E, F, and G described in table
2 of Sec. 176.170(c) of this
chapter.
12. At levels not exceeding 0.2
percent by weight of vinylidene
chloride homopolymers and/or
vinylidene chloride copolymers
complying with applicable regulations
in parts 175, 176, 177, 179, and 181
of this chapter. The vinylidene
chloride copolymers shall contain not
less than 50 weight percent of total
polymer units derived from vinylidene
chloride.
13. At levels not exceeding 0.025
percent by weight of chlorinated
isobutylene-isoprene copolymers
complying with Sec. 177.1420(a)(3)
of this chapter.
14. At levels not exceeding 0.5
percent by weight of the finished
rubber article complying with Sec.
177.2600 of this chapter.
[[Page 377]]
7-Oxa-3,20-diazadispiro- For use only:
[5.1.11.2]-heneicosan-21- 1. At levels not to exceed 0.5 percent
one,2,2,4,4-tetramethyl- by weight of olefin polymers
,hydrochloride, reaction complying with Sec. 177.1520 of this
products with epichlorohydrin, chapter, items 1.1, 3.1, and 3.2,
hydrolyzed, polymerized (CAS where the copolymers complying with
Reg. No. 202483-55-4). items 3.1 and 3.2 contain not less
than 85 weight percent of polymer
units derived from propylene; in
contact with all types of food
described in Table 1 of Sec. 176.170
of this chapter, provided that the
finished food-contact article will
have a capacity of at least 18.9
liters (5 gallons) when in contact
with food of types III, IV-A, V, VII-
A, and IX, described in Table 1 of
Sec. 176.170 of this chapter.
2. At levels not to exceed 0.5 percent
by weight of olefin polymers
complying with Sec. 177.1520 of this
chapter, items 2.1, 2.2, 3.1, and
3.2, having a density of not less
than 0.94 gram/milliliter, where the
copolymers complying with items 3.1
and 3.2 contain not less than 85
weight percent of polymer units
derived from ethylene; in contact
with food only under conditions of
use C, D, E, F, and G, described in
Table 2 of Sec. 176.170 of this
chapter, provided that the finished
food-contact article will have a
capacity of at least 18.9 liters (5
gallons) when in contact with food of
types III, IV-A, V, VII-A, and IX,
described in Table 1 of Sec. 176.170
of this chapter.
3. At levels not to exceed 0.3 percent
by weight of olefin polymers
complying with Sec. 177.1520 of this
chapter, items 2.1, 2.2, 3.1, 3.2,
3.3, 3.4, 3.5, 3.6, and 4.0, having a
density of less than 0.94 gram/
milliliter, in contact with food only
under conditions of use D, E, F, and
G, described in Table 2 of Sec.
176.170 of this chapter, provided
that the finished food-contact
article will have a capacity of at
least 18.9 liters (5 gallons) except
that, films and molded articles
containing not more than 0.2 percent
by weight of the stabilizer may
contact aqueous food of types I, II,
IV-B, VI, and VIII, described in
Table 1 of Sec. 176.170 of this
chapter with no restrictions on the
amount of food contacted.
Oxidized bis (hydrogenated For use only:
tallow alkyl) amines. 1. At levels not to exceed 0.1 percent
by weight of polypropylene polymers
complying with Sec. 177.1520(c) of
this chapter, item 1.1, 1.2, 1.3,
3.1a (density not less than 0.85 gram
per cubic centimeter and less than
0.91 gram per cubic centimeter),
3.2b, 3.4, and 3.5. The finished
polymers may be used in contact with
food types I, II, IV-B, VII-B and
VIII described in table 1 of Sec.
176.170(c) of this chapter, under
conditions of use B through H
described in table 2 of Sec.
176.170(c) of this chapter and with
food types III, IV-A, V, VI, VII-A,
and IX described in table 1 of Sec.
176.170(c) of this chapter, under
conditions of use D through H
described in table 2 of Sec.
176.170(c) of this chapter.
2. At levels not to exceed 0.075
percent by weight of high-density
polyethylene polymers complying with
Sec. 177.1520(c) of this chapter,
item 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a,
3.6 (density not less than 0.94 gram
per cubic centimeter), and 5. The
finished polymers may be used in
contact with food types I, II, IV-B,
VII-B and VIII described in table 1
of Sec. 176.170(c) of this chapter,
under conditions of use B through H
described in table 2 of Sec.
176.170(c) of this chapter, and with
food types III, IV-A, V, VI, VII-A
and IX described in table 1 of Sec.
176.170(c) of this chapter, under
conditions of use D through H
described in table 2 of Sec.
176.170(c) of this chapter.
2,2'-Oxamidobis[ethyl 3-(3,5-di- For use only:
tert-butyl-4- 1. At levels not to exceed 0.5 percent
hydroxyphenyl)propionate] (CAS by weight of polystyrene and rubber-
Reg. No. 70331-94-1). modified polystyrene complying with
Sec. 177.1640 of this chapter.
2. At levels not to exceed 0.5 percent
by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter, items 1.1, 1.2, and
1.3.
3. At levels not to exceed 0.5 percent
by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter, items 2.1, 2.2, 2.3,
3.1, 3.2, 3.3, 3.4, 3.5, and 4.0 that
contact food Types I, II, IV-B, VI,
VII-B and VIII described in table 1
of Sec. 176.170(c) of this chapter.
4. At levels not to exceed 0.1 percent
by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter, items 2.1, 2.2, 2.3,
3.1, 3.2, 3.3, and 4.0 that contact
food Types III, IV-A, V, VII-A, and
IX described in table 1 of Sec.
176.170(c) of this chapter; except
that olefin copolymers complying with
items 3.1 and 3.2 where the majority
of polymer units are derived from
propylene may contain the additive at
levels not to exceed 0.5 percent by
weight.
5. At levels not to exceed 0.1 percent
by weight of olefin polymers
complying with item 3.4 of Sec.
177.1520(c) of this chapter, that
contact food Types III, VII-A, and IX
described in table 1 of Sec.
176.170(c) of this chapter; except
that olefin copolymers complying with
item 3.4 where the majority of the
polymer units are derived from
propylene may contain the additive at
levels not to exceed 0.5 percent by
weight.
[[Page 378]]
Pentaerythritol and its stearate For use only in rigid polyvinyl
ester. chloride and/or in rigid vinyl
chloride copolymers complying with
Sec. 177.1980 of this chapter:
Provided, That the total amount of
pentaerythritol and/or
pentaerythritol stearate (calculated
as free pentaerythritol) does not
exceed 0.4 percent by weight of such
polymers.
N-Phenylbenzenamine reaction For use at levels not to exceed 0.5
products with 2,4,4- percent by weight of pressure-
trimethylpentenes (CAS Reg. No. sensitive adhesives complying with
68411-46-1). Sec. 175.125 of this chapter.
Phosphoric acid triesters with At levels not to exceed 0.1 percent by
triethylene glycol (CAS Reg. weight of polyethylene phthalate
No. 64502-13-2). polymers complying with Sec.
177.1630 of this chapter, such that
the polymers contact foods only of
Type VI-B described in table 1 of
Sec. 176.170(c) of this chapter.
Phosphorous acid, cyclic For use only:
butylethyl propanediol, 2,4,6- 1. At levels not to exceed 0.2 percent
tri-tert-butylphenyl ester (CAS by weight of olefin polymers
Reg. No. 161717-32-4), which complying with Sec. 177.1520(c) of
may contain not more than 1 this chapter, items 1.1, 1.2, or 1.3,
percent by weight of and items 2.1, 2.2, or 2.3 (where the
triisopropanolamine (CAS Reg. density of these polymers is not less
No. 122-20-3). than 0.94 gram per cubic centimeter),
and items 3.1 or 3.2, provided that
the finished polymer contacts foods
of types I, II, and VI-B as described
in table 1 of Sec. 176.170(c) of
this chapter only under conditions of
use B, C, D, E, F, G, and H as
described in table 2 of Sec.
176.170(c) of this chapter.
2. At levels not to exceed 0.1 percent
by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter, items 1.1, 1.2, or 1.3,
that contact food of types III, IV,
V, VI-A, VI-C, VII, VIII, and IX as
described in table 1 of Sec.
176.170(c) of this chapter, only
under conditions of use C, D, E, F,
and G as described in table 2 of Sec.
176.170(c) of this chapter.
3. At levels not to exceed 0.1 percent
by weight of olefin copolymers
complying with Sec. 177.1520(c) of
this chapter, items 3.1a, 3.1b, 3.2a,
or 3.2b, having a density less than
0.94 grams per cubic centimeter, in
contact with food only of types III,
IV, V, VI-A, VI-C, VII, VIII, and IX
and under conditions of use B, C, D,
E, F, G, and H as described in tables
1 and 2 of Sec. 176.170(c) of this
chapter; provided that the food-
contact surface does not exceed 0.003
inch (0.076 mm) in thickness.
4. At levels not to exceed 0.1 percent
by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter, items 2.1, 2.2, 2.3,
3.1(a), 3.1(b), 3.1(c), 3.2 (a), or
3.2(b), having a density not less
than 0.94 grams per cubic centimeter,
in contact with foods only of types
III, IV, V, VI-A, VI-C, VII, VIII,
and IX identified in Table 1 of Sec.
176.170(c) of this chapter, and under
conditions of use B through H as
described in Table 2 of Sec.
176.170(c) of this chapter; provided
that the food-contact surface does
not exceed 0.003 inch (0.076 mm) in
thickness.
Phosphorous acid, cyclic For use only at levels not to exceed
neopentanetetrayl bis(2,4-di- 0.10 percent by weight of olefin
tert-butylphenyl) ester (CAS polymers complying with Sec.
Reg. No. 26741-53-7) which may 177.1520(c) of this chapter, item
contain not more than 1 percent 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, or
by weight of 3.2, and limited to use in contact
triisopropanolamine (CAS Reg. with food only under conditions of
No. 122-20-3). use B, C, D, E, F, G, and H described
in table 2 of Sec. 176.170(c) of
this chapter. Olefin polymers that
contain more than 50 weight-percent
of polymer units derived from
ethylene shall have a density equal
to or greater than 0.94 gram per
cubic centimeter.
Phosphorous acid, cyclic For use only:
neopentanetetrayl bis (2,6-di- 1. At levels not to exceed 0.25
tert-butyl-4-methylphenyl)ester percent by weight of polypropylene
(CAS Reg. No. 80693-00-1). homopolymer and copolymers complying
with Sec. 177.1520 of this chapter,
for use with all food types described
in table 1 of Sec. 176.170(c) of
this chapter only under conditions of
use B through H described in table 2
of Sec. 176.170(c) of this chapter.
2. At levels not to exceed 0.05
percent by weight of polymers
complying with Sec. 177.1520(c) of
this chapter, item 3.1 or 3.2, and
with a maximum thickness of 100
micrometers (0.004 inch) for use with
all food types under conditions of
use B, C, D, E, F, G, and H described
in table 2 of Sec. 176.170(c) of
this chapter.
[[Page 379]]
Phosphorous acid, cyclic For use only:
neopentanetetrayl bis(2,4-di- 1. At levels not to exceed 0.86
tert-butylphenyl)ester (CAS percent by weight in polyvinyl
Reg. No. 26741-53-7). chloride and/or vinyl chloride
copolymers that comply with Secs.
177.1950, 177.1960, 177.1970, or
177.1980 of this chapter for use with
all food types described in table 1
of Sec. 176.170(c) of this chapter,
except those containing more than 15
percent alcohol, under conditions of
use B, C, D, E, F, G, and H described
in table 2 of Sec. 176.170(c) of
this chapter.
2. At levels not to exceed 0.25
percent by weight of polycarbonate
resins that comply with Sec.
177.1580 of this chapter for use with
all food types described in table 1
of Sec. 176.170(c) of this chapter,
except those containing more than 15
percent alcohol, under conditions of
use B, C, D, E, F, G, and H described
in table 2 of Sec. 176.170(c) of
this chapter.
3. At levels not to exceed 0.05
percent by weight in olefin polymers
complying with Sec. 177.1520(c) of
this chapter, item 3.1, that contain
more than 50 weight percent of
polymer units derived from ethylene
and whose density is less than 0.94
gram per cubic centimeter. The
average thickness of such polymers
intended for use in contact with food
types V and VII-A described in table
1 of Sec. 176.170(c) of this chapter
shall not exceed 80 micrometers
(0.003 inch).
Poly(1,4- For use only:
cyclohexylenedimethylene-3,3'- 1. In polypropylene complying with
thiodipropionate) partially Sec. 177.1520(c) of this chapter,
terminated with stearyl alcohol item 1.1, and used in contact with
and produced when approximately nonfatty, nonalcoholic food.
equal moles of 1,4- 2. At levels not to exceed 0.5 percent
cyclohexanedimethanol and 3,3'- by weight of polypropylene complying
thiodipropionic acid are made with Sec. 177.1520(c) of this
to react in the presence of chapter, item 1.1, and used in
stearyl alcohol so that the contact with fatty, nonalcoholic
final product has an average food. The average thickness of such
molecular weight in the range polymers in the form in which they
of 1,800-2,200, as determined contact fatty nonalcoholic food shall
by vapor pressure osmometry, not exceed 0.005 inch.
and has a maximum acid value of
2.5.
Poly[(1,3- For use only at levels not to exceed
dibutyldistannthianediylidene)- 0.2 by percent weight in polyvinyl
1,3-dithio] having the formula chloride resin where such resin
[C8H18Sn2S3]n (where n averages constitutes not less than 98.7
1.5-2) and produced so as to percent of a finished semirigid or
meet the following rigid polyvinyl chloride food-contact
specifications: Softening surface, provided that the finished
point, 130-145 deg.C; volatile food-contact article is employed only
components at 150 deg.C, less to package meat, cheese, and food
than 1.0 percent; sulphur Types I, VIII, and IX as described in
(sulfide) content in the range table 1 of Sec. 176.170(c) of this
20.5-22.0 percent; tin content chapter. The finished food-contact
in the range 52.0-53.2 percent. article containing this stabilizer,
when extracted with refined
cottonseed oil at 120 deg.F for 48
hours, using a volume-to-surface
ratio of 2 milliliters per square
inch of surface tested, shall yield
tin (Sn) not to exceed 0.0005
milligram per square inch of food-
contact surface.
Poly[(6-morpholino-s-triazine- For use only:
2,4-diyl)[(2,2,6,6-tetramethyl- 1. At levels not to exceed 0.3 percent
4-piperidyl)imino]hexamethylene by weight of polypropylene complying
[(2,2,6,6-tetramethyl-4- with Sec. 177.1520(c) of this
piperidyl)imino]] (CAS Reg. No. chapter, items 1.1, 1.2, and 1.3, and
82451-48-7). of ethylene polymers complying with
Sec. 177.1520(c) of this chapter,
items 2.1, 2.3, and 3.1, whose
specific gravity is not less than
0.94. The finished polymers are to
contact food only under conditions of
use D, E, F, and G described in table
2 of Sec. 176.170(c) of this
chapter.
2. At levels not to exceed 0.3 percent
by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter, items 2.1, 2.3, and
3.1, whose specific gravity is less
than 0.94, and of olefin polymers
complying with items 3.3., 3.4, 3.5,
and 4.0. The finished polymers are to
contact food in articles having a
volume of at least 18.9 liters (5
gallons) only under conditions of use
D, E, F, and G described in table 2
of Sec. 176.170(c) of this chapter.
Poly[[6-[(1,1,3,3- For use only:
tetramethybutyl) amino]-s- 1. At levels not to exceed 0.3 percent
triazine-2,4-diyl][2,2,6,6- by weight of polypropylene complying
tetramethyl-4- with Sec. 177.1520 of this chapter.
piperidyl)imino]hexamethylene[( 2. At levels not to exceed 0.2 percent
2,2,6,6-tetramethyl-4- by weight of polyethylene complying
piperidyl)imino]] (CAS Reg. No. with Sec. 177.1520 of this chapter,
70624-18-9). that has a density equal to or
greater than 0.94 gram per cubic
centimeter.
3. At levels not to exceed 0.3 percent
by weight of polyethylene that has a
density less than 0.94 gram per cubic
centimeter complying with Sec.
177.1520 of this chapter, items 2.1,
2.2, and 2.3, and of olefin polymers
and copolymers complying with items
3.1, 3.2, 3.3, 3.4, 3.5, 3.6, and 4.
The finished polymers are to contact
food only under conditions of use B
through H described in table 2 of
Sec. 176.170(c) of this chapter, and
when contacting fatty foods of Types
III, IV-A, V, VII-A, and IX described
in table 1 of Sec. 176.170(c) of
this chapter, the finished articles
are to have a volume of at least 18.9
liters (5 gallons).
[[Page 380]]
Potassium bromide and either For use at levels not exceeding 0.18
cupric acetate or cupric percent potassium bromide and 0.005
carbonate. percent copper as cupric acetate or
cupric carbonate by weight of nylon
66 resins complying with Sec.
177.1500 of this chapter; the
finished resins are used or are
intended to be used to contain foods
during oven baking or oven cooking at
temperatures above 250 deg.F. The
average thickness of such resins in
the form in which they contact food
shall not exceed 0.0015 inch.
1,3-propanediamine, N,N-1,2- For use only:
ethanediylbis-, polymer with 1. At levels not to exceed 0.3 percent
2,4,6-trichloro-1,3,5-triazine, by weight of polypropylene complying
reaction products with N-butyl- with Sec. 177.1520(c) of this
2,2,6,6-tetramethyl-4- chapter, items 1.1, 1.2, and 1.3.
piperidinamine (CAS Reg. No. 2. At levels not to exceed 0.2 percent
136504-96-6). by weight of olefin polymers having a
density greater than or equal to 0.94
grams per cubic centimeter and
complying with Sec. 177.1520(c) of
this chapter, items 2.1, 2.2, 2.3,
3.1, and 3.2.
3. At levels not to exceed 0.3 percent
by weight of olefin polymers having a
density less than 0.94 grams per
cubic centimeter and complying with
Sec. 177.1520(c) of this chapter,
items 2.1, 2.2, 2.3, 3.1, 3.2, 3.3,
3.4, 3.5, 3.6, and 4.0. The finished
polymers are to contact food only
under conditions of use B through H
described in Table 2 of Sec.
176.170(c) of this chapter, and when
used in contact with fatty foods of
Types III, IV-A, V, VII-A, and IX as
described in Table 1 of Sec.
176.170(c) of this chapter, the
finished articles are to have a
volume of at least 18.9 liters (5
gallons).
N,N'-1,3-Propanediylbis (3,5-di- For use only at levels not to exceed
tert-butyl-4- 0.6 percent by weight of rubber
hydroxyhydrocinnamamide) (CAS articles for repeated use complying
Reg. No. 69851-61-2). with Sec. 177.2600 of this chapter.
Siloxanes and silicones, methyl For use as an ultraviolet (UV)
hydrogen, reaction products stabilizer only at levels not to
with 2,2,6,6-tetramethyl-4-(2- exceed 0.33 percent by weight of
propenyloxy)piperidine (CAS polypropylene complying with Sec.
Reg. No. 182635-99-0). 177.1520(c) of this chapter, items
1.1a, 1.1b, 1.2, and 1.3, under
conditions of use D, E, F, and G, as
described in Table 2 of Sec. 176.170
of this chapter.
Stearoylbenzoylmethane (CAS Reg. For use only at levels not to exceed
No. 58446-52-9) consisting of a 0.5 percent by weight of vinyl
mixture of [beta]-diketones chloride homopolymers modified in
produced by the condensation of accordance with Sec. 178.3790(b)(1).
acetophenone and technical The finished polymers may be used in
methyl stearate.. contact with food containing up to 50
percent alcohol under conditions of
use B through H described in table 2
of Sec. 176.170(c) of this chapter.
Styrenated diphenylamine (CAS For use only in adhesives complying
Reg. No. 68442-68-2). with Sec. 175.105 of this chapter
and in rubber articles intended for
repeated use complying with Sec.
177.2600 of this chapter.
Tetradecanoic acid, lithium salt For use only at levels not to exceed
(CAS Reg. No. 20336-96-3). 0.15 percent by weight of
polypropylene and polypropylene
copolymers complying with Sec.
177.1520(c) of this chapter, items
1.1a, 1.1b, 3.1a, 3.1b, 3.1c, 3.2a,
and 3.2b. The finished polymers may
only be used in contact with food of
Types I, II, IV-B, VI-B, VII-B, and
VIII as described in table 1 of Sec.
176.170(c) of this chapter under
conditions of use B through H as
described in table 2 of Sec.
176.170(c) of this chapter, and with
food of Types III, IV-A, V, VI-A, VI-
C, VII-A, and IX described in table 1
of Sec. 176.170(c) of this chapter
under conditions of use C through G
as described in table 2 of Sec.
176.170(c) of this chapter.
2-[[2,4,8,10-Tetrakis(1,1- For use only at levels not to exceed
dimethylethyl)dibenzo[d,f][1,3, 0.075 percent by weight of olefin
2]-dioxaphosphepin-6-yl]oxy]- copolymers complying with Sec.
N,N-bis[2-[[2,4,8,10- 177.1520(c) of this chapter, items
tetrakis(1,1- 1.1, 1.2, 1.3, 2.1, 2.2, or 2.3:
dimethylethyl)dibenzo[d,f][1,3, Provided, That the density of the
2]dioxaphosphepin-6- olefin polymers complying with items
yl]oxy]ethyl]ethanamine (CAS 2.1, 2.2, or 2.3 is not less than
Reg. No. 80410-33-9). 0.94 gram per cubic centimeter: And
further provided, That the finished
polymers contact food only of Types
I, II, IV-B, VI-A, VI-B, VII-B, and
VIII described in table 1, of Sec.
176.170(c) of this chapter, under
conditions of use B through H
described in table 2 of Sec.
176.170(c) of this chapter and food
only of Types III, IV-A, V, VI-C, VII-
A, and IX described in table 1 of
Sec. 176.170(c) of this chapter,
under conditions of use C through G
described in table 2 of Sec.
176.170(c) of this chapter.
[[Page 381]]
Tetrakis [methylene(3,5- di-tert- For use only:
butyl-4- hydroxyhydro- 1. At levels not to exceed 0.5 percent
cinnamate)] methane (CAS Reg. by weight of all polymers used as
No. 6683-19-8). indirect additives in food packaging,
except as specified below.
2. At levels not to exceed 0.1 percent
by weight of petroleum wax or
synthetic petroleum wax complying
with Sec. 176.170(a)(5) of this
chapter.
3. At levels not to exceed 1.0 percent
by weight of:
(a) Pressure sensitive adhesives
complying with Sec. 175.125 of this
chapter.
(b) Can end cement formulations
complying with Sec.
175.300(b)(3)(xxxi) of this chapter.
(c) Petroleum alicyclic hydrocarbon
resins complying with Sec.
175.320(b)(3) of this chapter, Sec.
176.170(b)(2) of this chapter, or
their hydrogenated products complying
with Sec. 176.170(b)(2) of this
chapter.
(d) Rosin and rosin derivatives used
in accordance with parts 175 through
178 of this chapter.
(e) Terpene resins complying with
Sec. 175.300(b)(2)(xi) of this
chapter when such terpene resins are
used in accordance with Sec.
176.170(b) of this chapter.
(f) Resins and polymers complying
with Sec. 176.180 of this chapter.
(g) Closures with sealing gaskets
complying with Sec. 177.1210 of this
chapter.
(h) Polyoxymethylene copolymer as
provided in Sec. 177.2470(b)(1) of
this chapter.
(i) Petroleum hydrocarbon resin
complying with Sec. 178.3800.
(j) Reinforced wax complying with
Sec. 178.3850.
4,4-Thiobis(6-tert-butyl-m- For use only:
cresol). 1. As provided in Secs. 175.105 and
177.2600 of this chapter.
2. At levels not to exceed 0.25
percent by weight of polyethylene
complying with Sec. 177.1520 of this
chapter: Provided, That the specific
gravity of the polyethylene is not
less than 0.926: And further
provided, That the finished
polyethylene contacts food only of
the types identified in Sec.
176.170(c) of this chapter, table 1,
under Categories I, II, VI-B, and
VIII.
Thiodiethylene bis(3,5-di-tert- For use only:
butyl-4-hydroxyhydrocinnamate) 1. In adhesives complying with Sec.
(CAS Reg. No. 41484-35-9). 175.105 of this chapter.
2. At levels not to exceed 0.5 percent
by weight of pressure-sensitive
adhesives complying with Sec.
175.125 of this chapter, petroleum
alicyclic hydrocarbon resins
complying with Sec. 176.170 of this
chapter, resins and polymers
complying with Sec. 176.180 of this
chapter, closures with sealing
gaskets complying with Sec. 177.1210
of this chapter, and finished rubber
products complying with Sec.
177.2600 of this chapter.
Thiodipropionic acid............
1,3,5-Trimethyl-2,4,6-tris(3,5- For use only:
di-tert-butyl-4-hydroxybenzyl) 1. At levels not to exceed 0.5 percent
benzene (CAS Reg. No. 1709-70- by weight of polymers except nylon
2). resins identified in Sec. 177.1500
of this chapter.
2. At levels not to exceed 1 percent
by weight of nylon resins identified
in Sec. 177.1500 of this chapter.
Tri(mixed mono-and
dinonylphenyl) phosphite (which
may contain not more than 1
percent by weight of
triisopropanolamine)..
1, 11-(3, 6, 9-Trioxaundecyl) For use only as provided in Sec.
bis-3-(dodecylthio) propionate 175.300(b)(3)(xxxi) of this chapter
(CAS Reg. No. 64253-30-1). at 4.0 parts per 100 parts rubber.
1,3,5-Tris(3,5-di-tert-butyl-4- For use only:
hydroxybenzyl)-s-triazine- 1. At levels not to exceed 0.25
2,4,6(1H,3H,5H)trione (CAS Reg. percent by weight of polypropylene
No. 27676-62-6). complying with Sec. 177.1520 of this
chapter.
2. In polyethylene complying with Sec.
177.1520 of this chapter:
(a) At levels not to exceed 0.1
weight percent.
(b) At levels not to exceed 0.5
weight percent in contact with
nonfatty food.
3. At levels not to exceed 0.5 percent
by weight of ethylene-propylene-5-
ethylidine-2-norbornene terpolymers
complying with Sec. 177.1520 of this
chapter. The maximum thickness of
such polymers in the form in which
they contact food shall not exceed
0.005 inch.
4. At levels not exceeding 0.1 percent
by weight of olefin copolymers
complying with Sec. 177.1520(c) of
this chapter, items 3.1, 3.2, 3.3,
3.4, or 3.5.
5. At levels not exceeding 0.25
percent by weight of olefin
copolymers complying with Sec.
177.1520(c) of this chapter, items
3.1 and 3.2, and also containing not
less than 85 weight percent of
polymer units derived from propylene.
6. At levels not to exceed 0.2 percent
by weight of olefin polymers
complying with Sec. 177.1520(c)(4)
of this chapter. The finished
polymers may be used in contact with
food under conditions of use A
through H described in table 2 of
Sec. 176.170(c) of this chapter.
[[Page 382]]
1,3,5-Tris(3,5-di-tert-butyl-4- For use only in contact with nonfatty
hydro-xyhydrocinnamoyl) foods:
hexahydro-s-triazine. 1. At levels not to exceed 0.25
percent by weight of polypropylene
complying with Sec. 177.1520 of this
chapter.
2. At levels not to exceed 0.1 percent
by weight of polyethylene complying
with Sec. 177.1520 of this chapter.
3. At levels not to exceed 0.5 percent
by weight of ethylene-propylene-5-
ethylidine-2-norbornene terpolymers
complying with Sec. 177.1520 of this
chapter. The maximum thickness of
such polymers in the form in which
they contact food shall not exceed
0.005 inch.
1,3,5-Tris(4-tert-butyl-3- For use only:
hydroxy-2,6-dimethylbenzyl)- 1. At levels not to exceed 0.1 percent
1,3,5-triazine-2,4,6-(1H,3H,5H)- by weight of olefin polymers
trione. [CAS Reg. No. 40601-76- complying with Sec. 177.1520 of this
1]. chapter, under conditions of use A
through H described in table 2 of
Sec. 176.170(c) of this chapter.
2. At levels not to exceed 0.1 percent
by weight of polystyrene and rubber-
modified polystyrene that comply with
Sec. 177.1640 of this chapter,
provided that the finished
polystyrene and rubber-modified
polystyrene contact food only under
the conditions described in Sec.
176.170(c) of this chapter, table 2,
under conditions of use E through G.
[[Page 383]]
Tris(2,4-di-tert- For use only:
butylphenyl)phosphite. (CAS 1. At levels not to exceed 0.5 percent
Reg. No. 31570-04-4). by weight of elastomers used in
rubber articles complying with Sec.
177.2600 of this chapter.
2. At levels not to exceed 1 percent
by weight of nylon resins complying
with Sec. 177.1500 of this chapter:
Provided, That the finished polymer
contacts food only under conditions
of use E, F, and G described in table
2 of Sec. 176.170(c) of this
chapter.
3. At levels not to exceed 0.3 percent
by weight of polycarbonate resins
complying with Sec. 177.1580 of this
chapter.
4. At levels not to exceeds 0.2
percent by weight of polystyrene and
rubber-modified polystyrene polymers
complying with Sec. 177.1640 of this
chapter: Provided, that the finished
polymer contacts food only under
conditions of use B, C, D, E, F, G,
and H described in table 2 of Sec.
176.170(c) of this chapter.
5. At levels not to exceed 0.25
percent by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter, item 1.1, 1.2, or 1.3.
6. At levels not to exceed 0.2 percent
by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter, items 2.1, 2.2, 2.3,
3.1(a), 3.1(b), 3.1(c), 3.2(a), or
3.2(b). The finished polymers
complying with items 2.1, 2.2, or 2.3
having a density less than 0.94 gram
per cubic centimeter and a thickness
greater than 0.051 millimeter (0.002
inch), either shall have a level of
tris(2,4-di-tert-
butylphenyl)phosphite that shall not
exceed 0.062 milligram per square
inch of food-contact surface or shall
contact all food types identified in
Table 1 of Sec. 176.170(c) of this
chapter only under conditions of use
E, F, and G described in Table 2 of
Sec. 176.170(c) of this chapter.
7. At levels not to exceed 0.2 percent
by weight of ethylene-vinyl-acetate
copolymers complying with Sec.
177.1350 of this chapter, and that
are limited to use in contact with
food only under conditions of use E,
F, and G described in table 2 of Sec.
176.170(c) of this chapter. The
average thickness of such polymers in
the form in which they contact fatty
food shall not exceed 0.1 millimeter
(0.004 inch).
8. At levels not to exceed 0.2 percent
by weight of olefin polymers
complying with Sec. 177.1520(c) of
this chapter, item 4. The finished
polymers having a thickness greater
than 0.051 millimeter (0.002 inch),
shall contact food only under
conditions of use E, F, and G
described in table 2 of Sec.
176.170(c) of this chapter.
9. At levels not to exceed 0.5 percent
by weight of acrylic and modified
acrylic plastics, semirigid and
rigid, complying with Sec. 177.1010
of this chapter.
10. At levels not to exceed 0.1
percent by weight of isobutylene
polymers complying with Sec.
177.1420 of this chapter.
11. In adhesives complying with Sec.
175.105 of this chapter.
12. At levels not to exceed 0.5
percent by weight of pressure
sensitive adhesives complying with
Sec. 175.125 of this chapter.
13. At levels not to exceed 0.5
percent by weight of can end cement
formulations complying with Sec.
175.300(b)(3) (xxxi) of this chapter.
14. At levels not to exceed 0.5
percent by weight of side seam cement
formulations complying with Sec.
175.300(b)(3) (xxxii) of this
chapter.
15. At levels not to exceed 0.5
percent by weight of petroleum
alicyclic hydrocarbon resins
complying with Sec. 175.320(b)(3) of
this chapter.
16. At levels not to exceed 0.5
percent by weight of petroleum
alicyclic hydrocarbon resins or their
hydrogenated products complying with
Sec. 176.170(b) (2) of this chapter.
17. At levels not to exceed 0.5
percent by weight of resins and
polymers complying with Sec.
176.180(b) of this chapter.
18. At levels not to exceed 0.5
percent by weight of rosins and rosin
derivatives complying with Sec.
176.210(d)(3) of this chapter.
19. At levels not to exceed 0.5
percent by weight of closures with
sealing gaskets complying with Sec.
177.1210 of this chapter.
20. At levels not to exceed 0.5
percent by weight of petroleum
hydrocarbon resin, and rosins and
rosin derivatives complying with Sec.
178.3800(b).
21. At levels not to exceed 0.5
percent by weight of reinforced wax
complying with Sec. 178.3850.
22. At levels not to exceed 0.5
percent by weight of olefin
copolymers complying with Sec.
177.1520(c) of this chapter, item
3.3. The finished polymers may be
used in contact with food under
conditions of use A through H
described in table 2 of Sec.
176.170(c) of this chapter.
23. At levels not to exceed 0.15
percent by weight of poly-1-butene
resins and butene/ethylene copolymers
complying with Sec. 177.1570 of this
chapter: Provided, that the finished
polymer contacts food only under
conditions of use B through H
described in table 2 of Sec.
176.170(c) of this chapter.
[[Page 384]]
Tris(2-methyl-4-hydroxy-5-tert- For use only:
butylphenyl)butane (CAS Reg. 1. At levels not to exceed 0.25
No. 1843-03-4). percent by weight of polymers used as
provided in Sec. 176.180 of this
chapter.
2. At levels not to exceed 0.25
percent by weight of the following
polymers when used in articles that
contact food of Types I, II, IV-B, VI-
B, VII-B, and VIII described in table
1 of Sec. 176.170(c) of this
chapter: Olefin polymers complying
with Sec. 177.1520(c) of this
chapter, items 1.1, 1.2, 1.3, 2.1,
2.2, 2.3, 3.1, 3.2, 3.3, or 4 or
complying with other sections in
parts 174, 175, 176, 177, 178 and
Sec. 179.45 of this chapter; vinyl
chloride polymers; and/or vinyl
chloride copolymers complying with
Sec. 177.1980 of this chapter.
3. At levels not to exceed 0.1 percent
by weight of the following polymers
when used in articles that contact
food of Types III, IV-A, V, VI-A, VI-
C, VII-A, and IX described in table 1
of Sec. 176.170(c) of this chapter:
Olefin polymers complying with Sec.
177.1520(c) of this chapter, items
1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1,
3.2, 3.3, or 4 or complying with
other sections in parts 174, 175,
176, 177, 178 and Sec. 179.45 of
this chapter; vinyl chloride
polymers; and/or vinyl chloride
copolymers complying with Sec.
177.1980 of this chapter.
4. As provided in Sec. 175.105 of
this chapter.
5. At levels not to exceed 0.2 percent
by weight of polystyrene and/or
modified polystyrene polymers
identified in Sec. 177.1640 of this
chapter.
6. At levels not to exceed 0.25
percent by weight of acrylonitrile-
butadiene-styrene copolymers used in
contact with nonalcoholic foods.
7. At levels not to exceed 1 percent
by weight of closure-sealing gasket
compositions complying with Sec.
177.1210(b) of this chapter.
Zinc dibutyldithiocarbamate (CAS For use only:
Reg. No. 136-23-2). 1. At levels not to exceed 0.2 percent
by weight of isobutyleneisoprene
copolymers complying with Sec.
177.1420 of this chapter: Provided,
That the finished copolymers contact
food only of the types identified in
Sec. 176.170(c) of this chapter,
table 1, under Types V, VII, VIII,
and IX.
2. At levels not to exceed 0.02
percent by weight of polypropylene
polymers complying with Sec.
177.1520(c), item 1.1 of this
chapter.
Zinc palmitate..................
Zinc salicylate................. For use only in rigid polyvinyl
chloride and/or in rigid vinyl
chloride copolymers complying with
Sec. 177.1980 of this chapter:
Provided, That total salicylates
(calculated as the acid) do not
exceed 0.3 percent by weight of such
polymers.
Zinc stearate...................
------------------------------------------------------------------------
\1\ Copies are available from the American Society for Testing and
Materials, 1916 Race Street, Philadelphia, Pa. 19103.
[42 FR 14609, Mar. 15, 1977]
Editorial Note: For Federal Register citations affecting
Sec. 178.2010, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.2550]
[Page 384]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart C--Antioxidants and Stabilizers
Sec. 178.2550 4-Hydroxymethyl-2,6-di-tert-butylphenol.
4-Hydroxymethyl-2,6-di-tert-butyl-phenol may be safely used as an
antioxidant in articles intended for use in contact with food, in
accordance with the following prescribed conditions:
(a) The additive has a solidification point of 140 deg.-141 deg.C.
(b) The concentration of the additive and any other permitted
antioxidants in the finished food-contact article does not exceed a
total of 0.5 milligram per square inch of food-contact surface.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.2650]
[Page 384-387]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart C--Antioxidants and Stabilizers
Sec. 178.2650 Organotin stabilizers in vinyl chloride plastics.
The organotin chemicals identified in paragraph (a) of this section
may be safety used alone or in combination, at levels not to exceed a
total of 3 parts per hundred of resin, as stabilizers in vinyl chloride
homopolymers and copolymers complying with the provisions of
Sec. 177.1950 or Sec. 177.1980 of this chapter and that are identified
for use in contact with food of types I, II, III, IV (except liquid
milk), V, VI (except malt beverages and carbonated nonalcoholic
beverages), VII, VIII, and IX described in table 1 of Sec. 176.170(c) of
this chapter, except for the organotin chemical identified in paragraph
(a)(3)
[[Page 385]]
of this section, which may be used in contact with food of types I
through IX at temperatures not exceeding 75 deg.C (167 deg.F), and
further that the organotin chemicals identified in paragraphs (a) (5)
and (6) of this section may be used in contact with food of types I
through IX at temperatures not exceeding 66 deg.C (150 deg.F),
conditions of use D through G described in table 2 of Sec. 176.170(c) of
this chapter, and further that dodecyltin chemicals identified in
paragraph (a)(7) of this section which may be used in contact with food
of types I, II, III, IV (except liquid milk), V, VI (except malt
beverages and carbonated nonalcoholic beverages), VII, VIII, and IX
described in table 1 of Sec. 176.170(c) of this chapter at temperatures
not exceeding 71 deg.C (160 deg.F), in accordance with the following
prescribed conditions:
(a) For the purpose of this section, the organotin chemicals are
those listed in paragraphs (a) (1), (2), (3), (4), (5), (6), and (7) of
this section.
(1) Di(n-octyl)tin S,S'-bis(isooctylmercaptoacetate) is an octyltin
chemical having 15.1 to 16.4 percent by weight of tin (Sn) and having
8.1 to 8.9 percent by weight of mercapto sulfur. It is made from di(n-
octyl)tin dichloride or di(n-octyl)tin oxide. The isooctyl radical in
the mercaptoacetate is derived from oxo process isooctyl alcohol. Di(n-
octyl)tin dichloride has an organotin composition that is not less than
95 percent by weight of di(n-octyl)tin dichloride and not more than 5
percent by weight of tri(n-octyl)tin chloride. Di(n-octyl)tin oxide has
an organotin composition that is not less than 95 percent by weight of
di(n-octyl)tin oxide and not more than 5 percent by weight of bis[tri(n-
octyl)tin] oxide, and/or mono n-octyltin oxide.
(2) Di(n-octyl) tin maleate polymer is an octyltin chemical having
the formula
[(C8H17)2SnC4H2O4
]n (where n is between 2 and 4 inclusive), having 25.2 to
26.6 percent by weight of tin (Sn) and having a saponification number of
225 to 255. It is made from di(n-octyl)tin dichloride or di(n-octyl)tin
oxide meeting the specifications prescribed for di(n-octyl) tin
dichloride or di(n-octyl) tin oxide in paragraph (a)(1) of this section.
(3) C10-16-Alkyl mercaptoacetates reaction
products with dichlorodioctylstannane and trichlorooctylstannane (CAS
Reg. No. 83447-69-2) is an organotin chemical mixture having 10.8 to
11.8 percent by weight of tin (Sn) and having 8.0 to 8.6 percent by
weight of mercapto sulfur. It is made from a mixture of di(n-octyl)tin
dichloride and (n-octyl)tin trichloride which has an organotin
composition that is not less than 95 percent by weight di(n-octyl)tin
dichloride/(n-octyl)tin trichloride, and not more than 1.5 percent by
weight of tri(n-octyl)tin chloride. The alkyl radical in the
mercaptoacetate is derived from a mixture of saturated n-alcohols which
has a composition that is not less than 50 percent by weight tetradecyl
alcohol, and that is not more than 50 percent by weight total of decyl
alcohol and/or dodecyl alcohol, and/or hexadecyl alcohol.
(4) (n-Octyl)tin S,S'S[dprime] tris(isooctyl-mercaptoacetate) is an
octyltin chemical having the formula n-
C8H17Sn(SCH2CO2C8H
17)3 (CAS Reg. No. 26401-86-5) having 13.4 to 14.8
percent by weight of tin (Sn) and having 10.9 to 11.9 percent by weight
of mercapto sulfur. It is made from (n-octyl)tin trichloride. The
isooctyl radical in the mercaptoacetate is derived from oxo process
isooctyl alcohol. The (n-octyl)tin trichloride has an organotin
composition that is not less than 95 percent by weight of (n-octyl)tin
trichloride and not more than 5 percent by weight of tri(n-octyl)tin
chloride.
(5) Bis(beta-carbobutoxyethyl)tin bis(isooctylmercaptoacetate) (CAS
Reg. No. 63397-60-4) is an estertin chemical having 14.0 to 15.0 percent
by weight of tin (Sn) and having 7.5 to 8.5 percent by weight of
mercapto sulfur. It is made from bis(beta-carbobutoxyethyl)tin
dichloride. The isooctyl radical in the mercaptoacetate is derived from
oxo process primary octyl alcohols. The bis(beta-carbobutoxyethyl)tin
dichloride has an organotin composition that is not less than 95 percent
by weight of bis(beta-carbobutoxyethyl)tin dichloride and not more than
5 percent by weight of bis(beta-carbobutoxyethyltin trichloride. The
triestertin chloride content of bis(beta-carbobutoxyethyltin)
[[Page 386]]
dichloride shall not exceed 0.02 percent. p
(6) Beta-carbobutoxyethyltin tris(isooctylmercaptoacetate) (CAS Reg.
No. 63438-80-2) is an estertin chemical having 13.0 to 14.0 percent by
weight of tin (Sn) and having 10.5 to 11.5 percent by weight of mercapto
sulfur. It is made from beta-carbobutoxyethyltin trichloride. The
isooctyl radical in the mercaptoacetate is derived from oxo process
primary octyl alcohol. The beta-carbobutoxyethyltin trichloride has an
organotin composition that is not less than 95 percent by weight of
beta-carbobutoxyethyltin trichloride and not more than 5 percent total
of triestertin chloride and diestertin chloride.
(7) The dodecyltin stabilizer is a mixture of 50 to 60 percent by
weight of n-dodecyltin S,S',S[dprime]-tris(isooctylmercaptoacetate) (CAS
Reg. No. 67649-65-4) and 40 to 50 percent by weight of di(n-dodecyl)tin
S,S'-di(isooctylmercaptoacetate) (CAS Reg. No. 84030-61-5) having 13 to
14 percent by weight of tin (Sn) and having 8 to 9 percent by weight of
mercapto sulfur. It is made from a mixture of dodecyltin trichloride and
di(dodecyl)tin dichloride which has not more than 0.2 percent by weight
of dodecyltin trichloride, not more than 2 percent by weight of
dodecylbutyltin dichloride and not more than 3 percent by weight of
tri(dodecyl)tin chloride. The isooctyl radical in the mercaptoacetate is
derived from oxo process primary octyl alcohols.
(b) The vinyl chloride plastic containers, film or panels in the
finished form in which they are to contact food, shall meet the
following limitations:
(1) The finished plastics intended for contact with foods of the
types listed in this section shall be extracted with the solvent or
solvents characterizing those types of foods as determined from table 2
of Sec. 176.170(c) of this chapter at the temperature reflecting the
conditions of intended use as determined therein. Additionally,
extraction tests for acidic foods shall be included and simulated by 3-
percent acetic acid at temperatures specified for water in table 2 of
Sec. 176.170(c) of this chapter. The extraction tests shall cover at
least three equilibrium periodic determinations, as follows:
(i) The exposure time for the first determination shall be at least
72 hours for aqueous solvents, and at least 6 hours for heptane.
(ii) Subsequent determinations shall be at a minimum of 24-hour
intervals for aqueous solvents, and 2-hour intervals for heptane. These
tests shall yield total octylin stabilizers not to exceed 0.5 parts per
million as determined by analytical method entitled "Atomic Absorption
Spectrometric Determination of Sub-part-per-Million Quantities of Tin in
Extracts and Biological Materials with Graphite Furnace," Analytical
Chemistry, Vol. 49, p. 1090-1093 (1977), which is incorporated by
reference.Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(iii) Subsequent determinations for the dodecyltin mixture described
in paragraph (a)(7) of this section shall be at a minimum of 24-hour
intervals for aqueous solvents and 2-hour intervals for heptane. These
tests shall yield di(n-octyl)tin S,S'-bis(isooctylmercaptoacetate), or
di(n-octyl)tin maleate polymer, or (C10-C16)-
alkylmercaptoacetate reaction products with dichlorodioctylstannane and
trichlorooctylstannane, or n-octyltin S,S',S[dprime]-
tris(isooctylmercaptoacetate), tris(isooctylmercaptoacetate) and di(n-
dodecyl)tin bis(isooctylmercaptoacetate) or any combination thereof, not
to exceed 0.5 parts per million as determined by an analytical method
entitled "Atomic Absorption Spectrophotometric Determination of Sub-
part-per-Million Quantities of Tin in Extracts and Biological Materials
with Graphite Furnace," Analytical Chemistry, Vol. 49, pp. 1090-1093
(1977), which is incorporated by reference in accordance with 5 U.S.C.
552(a). The availability of this incorporation by reference is given in
paragraph (b)(1)(ii) of this section.
(2) In lieu of the tests prescribed in paragraph (b) (1) of this
section, the finished plastics intended for contact
[[Page 387]]
with foods only of Types II, V, VI-A (except malt beverages), and VI-C
may be end-tested with food-simulating solvents, under conditions of
time and temperature, as specified below, whereby such tests shall yield
the octyltin residues cited in paragraph (b)(1) of this section not in
excess of 0.5 ppm:
------------------------------------------------------------------------
Temperature
Food-simulating solvent Time (degrees
(hours) Fahrenheit)
------------------------------------------------------------------------
Type II............... Acetic acid, 3 pct....... 48 135
Type V................ Heptane.................. 2 100
Type VI-A............. Ethyl alcohol, 8 pct..... 24 120
Type VI-C............. Ethyl alcohol, 50 percent 24 120
------------------------------------------------------------------------
[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982;
48 FR 7170, Feb. 18, 1983; 48 FR 42972, Sept. 21, 1983; 48 FR 51612,
Nov. 10, 1983; 49 FR 8432, Mar. 7, 1984; 50 FR 62, Jan. 2, 1985; 50 FR
3510, Jan. 25, 1985; 50 FR 37998, Sept. 19, 1985; 50 FR 47212, Nov. 15,
1985; 54 FR 24898, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3010]
[Page 387]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3010 Adjuvant substances used in the manufacture of foamed plastics.
The following substances may be safely used as adjuvants in the
manufacture of foamed plastics intended for use in contact with food,
subject to any prescribed limitations:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Azodicarbonamide...................... For use as a blowing agent in
polyethylene complying with
item 2.1 in Sec. 177.1520(c)
of this chapter at a level not
to exceed 5 percent by weight
of finished foamed
polyethylene.
1,1-Difluoroethane (CAS Reg. No. 75-37- For use as a blowing agent in
6). polystyrene.
Isopentane............................ For use as a blowing agent in
polystyrene.
n-Pentane............................. Do.
1,1,2,2-Tetra-chloroethylene.......... For use only as a blowing agent
adjuvant in polystyrene at a
level not to exceed 0.3 percent
by weight of finished foamed
polystyrene intended for use in
contact with food only of the
types identified in Sec.
176.170(c) of this chapter,
table 1, under Categories I,
II, VI, and VIII.
Toluene............................... For use only as a blowing agent
adjuvant in polystyrene at a
level not to exceed 0.35
percent by weight of finished
foamed polystyrene.
------------------------------------------------------------------------
[47 FR 22090, May 21, 1982, as amended at 58 FR 64895, Dec. 10, 1993]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3120]
[Page 387-388]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3120 Animal glue.
Animal glue may be safely used as a component of articles intended
for use in producing, manufacturing, packing, processing, preparing,
treating, packaging, transporting, or holding food, subject to the
provisions of this section.
(a) Animal glue consists of the proteinaceous extractives obtained
from hides, bones, and other collagen-rich substances of animal origin
(excluding diseased or rotted animals), to which may be added other
optional adjuvant substances required in its production or added to
impart desired properties.
(b) The quantity of any substance employed in the production of
animal glue does not exceed the amount reasonably required to accomplish
the intended physical or technical effect nor any limitation further
provided.
(c) Any substance employed in the production of animal glue and
which is the subject of a regulation in parts 174, 175, 176, 177, 178
and Sec. 179.45 of this chapter conforms with any specification in such
regulation.
(d) Optional adjuvant substances employed in the production of
animal glue include:
(1) Substances generally recognized as safe in food.
(2) Substances subject to prior sanction or approval for use in
animal glue and used in accordance with such sanction or approval.
(3) Substances identified in this paragraph (d)(3) and subject to
such limitations as are provided:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Alum (double sulfate of aluminum and
ammonium, potassium, or sodium).
4-Chloro-3-methylphenol(p-chlorome- For use as preservative only.
tacresol).
[[Page 388]]
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- For use as preservative only.
zine-2-thione.
Disodium cyanodithioimidocarbonate....... Do.
Defoaming agents......................... As provided in Sec. 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 Sec.
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 follows:
(1) The use of animal glue in any substance or article that is the
subject of a regulation in this subpart conforms with any specifications
or limitations prescribed by such regulation for the finished form of
the substance or article.
(2) It is used as an adhesive or component of an adhesive in
accordance with the provisions of Sec. 175.105 of this chapter.
(3) It is used as a colloidal flocculant added to the pulp
suspension prior to the sheet-forming operation in the manufacture of
paper and paperboard.
(4) It is used as a protective colloid in resinous and polymeric
emulsion coatings.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3125]
[Page 388]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3125 Anticorrosive agents.
The substances listed in this section may be used as anticorrosive
agents in food-contact materials subject to the provisions of this
section:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Zinc hydroxy phosphite (CAS Reg. No. 55799- For use only as a component
16-1). of resinous and polymeric
food-contact coatings
intended for repeated use
in contact with dry foods.
------------------------------------------------------------------------
[50 FR 21835, May 29, 1985]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3130]
[Page 388-391]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3130 Antistatic and/or antifogging agents in food-packaging materials.
The substances listed in paragraph (b) of this section may be safely
used as antistatic and/or antifogging agents in food-packaging
materials, subject to the provisions of this section:
(a) The quantity used shall not exceed the amount reasonably
required to accomplish the intended technical effect.
(b) List of substances:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
N-Acyl sarcosines where the acyl group For use only:
is lauroyl, oleoyl, or derived from 1. As antistatic and/or
the combined fatty acids of coconut antifogging agent at levels
oil. not to exceed a total of 0.15
pct by weight of polyolefin
film used for packaging 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 copolymer film
complying with Sec. 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 Sec. 176.170(c) of
this chapter. The average
thickness of such ethylene-
vinyl acetate copolymer film
shall not exceed 0.003 inch
when used for packaging meat,
fresh fruits, and fresh
vegetables.
Alpha-(Carboxymethyl)-omega- For use only as an antistatic
(tetradecyloxy)polyoxyethylene). and/or antifogging agent at
levels not to exceed 0.2 pct
by weight in polyolefin film
not exceeding 0.001 inch
thickness.
[[Page 389]]
Alkyl mono- and disulfonic acids, For use only:
sodium salts (produced from n-alkanes 1. As antistatic agents at
in the range of C10-C18 with not less levels not to exceed 0.1
than 50 percent C14-C16). percent by weight of
polyolefin films that comply
with Sec. 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 described in
table 1 of Sec. 176.170(c) of
this chapter, and under
conditions of use E, F, and G
described in table 2 of Sec.
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 complying with
Sec. 177.1640(c) of this
chapter under conditions of
use B through H described in
table 2 of Sec. 176.170(c) of
this chapter.
Aluminum Borate For use only:
((9Al2O3)2(B2O3), CAS Reg. No. 1. At levels not to exceed 1
11121-16-7) produced by reaction percent by weight of
between aluminum oxide and/or aluminum polypropylene films complying
hydroxide with boric acid and/or with Sec. 177.1520(c) of this
metaboric acid at temperatures in chapter, item 1.1, of
excess of 1000 deg.C. polyethylene films complying
with Sec. 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
Sec. 177.1520(c) of this
chapter, items 3.1(a), 3.1(b),
3.2(a), and 3.2(b). The
finished polymers may be used
in contact with all food types
identified in Table 1 of Sec.
176.170(c) of this chapter,
under conditions of use A
through H as described in
Table 2 of Sec. 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
polypropylene films complying
with Sec. 177.1520(c) of this
chapter, item 1.1, of
polyethylene films complying
with Sec. 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
Sec. 177.1520(c) of this
chapter, items 3.1(a), 3.1(b),
3.2(a), and 3.2(b). The
finished polymers may be used
in contact with all food types
identified in Table 1 of Sec.
176.170(c) of this chapter
under conditions of use B
through H as described in
Table 2 of Sec. 176.170(c) of
this chapter. The thickness of
the films shall not exceed
0.005 inch.
N,N-Bis(2-hydroxyethyl)alkyl(C12- For use only as an antistatic
C18)amine. agent at levels not to exceed
0.1 pct by weight of
polyolefin food-contact films.
N,N-bis(2-hydroxyethyl)alkyl (C13-C15) For use only:
amine (CAS Reg. No. 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 (having a density
[ge]0.95 g/cm\3\ and
polypropylene containers that
contact food only of the types
identified in Sec. 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 Sec. 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 Sec.
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 Sec. 176.170(c) of this
chapter.
[[Page 390]]
N,N-Bis(2-hydroxyethyl) alkylamine, For use only:
where the alkyl groups (C1-C18) are 1. As an antistatic agent at
derived from tallow. levels not to exceed 0.15 pct
by weight in molded or
extruded polyethylene
containers that contact food
only of the types identified
in Sec. 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 Sec. 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 copolymer coatings
complying with Sec. 175.320,
Sec. 177.1200, or Sec.
177.1630 of this chapter,
provided that such coatings
contact food only of the types
identified in Sec. 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 Sec. 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 For use only:
produced when diethanolamine is made 1. As an antistatic agent at
to react with methyl laurate such that levels not to exceed 0.5
the finished product: Has a minimum percent by weight of molded or
melting point of 36 deg.C; has a extruded polyethylene
minimum amide assay of 90 percent; containers intended for
contains no more than 2 percent by contact with honey, chocolate
weight of free diethanolamine; and syrup, liquid sweeteners,
contains no more than 0.5 percent by condiments, flavor extracts
weight of N,N, bis(2- and liquid flavor
hydroxyethyl)piperazine, as determined concentrates, grated cheese,
by paper chromatography method. light and heavy cream, yogurt,
and foods of Type VIII as
described in table 1 of Sec.
176.170(c) of this chapter.
2. As an antistatic agent at
levels not to exceed 0.2
percent by weight in
polypropylene films complying
with Sec. 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 Sec.
176.170(c) of this chapter,
and under conditions of use B
through H described in table 2
of Sec. 176.170(c) of this
chapter. The average thickness
of such polypropylene film
shall not exceed 0.001 inches
(30 micrometers).
N,N-Bis(2-hydroxyethyl) dodecanamide For use only as an antistatic
produced when diethanolamine is made agent at levels not to exceed
to react with methyl laurate such that 0.5 percent by weight of
the finished product: Has a minimum molded or extruded
melting point of 36 deg.C; has a polyethylene containers
minimum amide assay of 90 percent; intended for contact with
contains no more than 2 percent by honey, chocolate syrup, liquid
weight of free diethanolamine; and sweeteners, condiments, flavor
contains no more than 0.5 percent by extracts and liquid flavor
weight of N,N'-bis(2-hydroxyethyl) concentrates, grated cheese,
piperazine, as determined by paper light and heavy cream, yogurt,
chromatography method. and foods of Type VIII as
described in table 1 of Sec.
176.170(c) of this chapter.
N,N-Bis(2-hydroxyethyl) octadecylamine, For use only as an antistatic
Chemical Abstracts Service Registry agent at levels not to exceed
No. 10213-78-2, N-(2-hydroxyethyl)-N- 0.45 percent by weight in
octadecylglycine (monosodium salt), polypropylene films complying
Chemical Abstracts Service Registry with Sec. 177.1520 of this
No. 66810-88-6, and N,N-Bis(2- chapter, and used for
hydroxyethyl)-N-(carboxymethyl) packaging food of Types I, II,
octadecanaminum hydroxide (inner III, IV, V, VI-B, VII, VIII,
salt), Chemical Abstracts Service and IX described in table 1 of
Registry No. 24170-14-7, as the major Sec. 176.170(c) of this
components of a mixture prepared by chapter, and under conditions
reacting ethylene oxide with of use B through H described
octadecylamine and further reacting in table 2 of Sec.
this product with sodium 176.170(c). The average
monochloroacetate and sodium thickness of such
hydroxide, such that the final product polypropylene film shall not
has: A nitrogen content of 3.3-3.8 exceed 0.002 inch.
percent; a melting point of 42 deg.-50
deg.C; and a pH of 10.0-11.5 in a 1
percent by weight aqueous solution.
[alpha]-n-Dodecanol-omega-hydroxypoly For use only as an antistatic
(oxyethylene) produced by the agent at levels not to exceed
condensation of 1 mole of n-dodecanol 0.2 pct by weight in low-
with an average of 9.5 moles of density polyethylene film
ethylene oxide to form a condensate having an average thickness
having a hydroxyl content of 2.7 to not exceeding 0.005 inch.
2.9 pct and having a cloud point of 80
deg.C to 92 deg.C in 1 pct by weight
aqueous solution.
Glycerol ester mixtures of ricinoleic As an antifogging agent at
acid, containing not more than 50 levels not exceeding 1.5 pct
percent monoricinoleate, 45 pct by weight of permitted
diricinoleate, 10 pct triricinoleate, plasticized vinyl chloride
and 3.3 pct free glycerine. homo-and/or copolymers.
N-Methacryloyloxyethyl-N, N- For use only as an antistatic
dimethylammonium-[alpha]-N-methyl agent at levels not to exceed
carboxylate chloride sodium salt, 0.2 percent by weight of
octadecyl methacrylate, ethyl polyolefin films that contact
methacrylate, cyclohexyl methacrylate, foods under the conditions of
N-vinyl-2-pyrrolidone copolymer (CAS use B through H described in
Reg. No. 66822-60-4). table 2 of Sec. 176.170(c) of
this chapter. The average
thickness of such polyolefin
film shall not exceed 0.02
centimeter (0.008 inch).
[[Page 391]]
Octadecanoic acid 2-[2-hydroxyethyl) For use only as an antistatic
octadecylamino]ethyl ester (CAS Reg. agent at levels such that the
No. 52497-24-2), (octadecylimino) product of film thickness in
diethylene distearate (CAS Reg. No. microns times the weight
94945-28-5), and octadecyl percent additive does not
bis(hydroxyethyl)amine (CAS Reg. No. exceed 16, in polypropylene
10213-78-2), as the major components films complying with Sec.
of a mixture prepared by reacting 177.1520(c)1.1 of this
ethylene oxide with octadecylamine and chapter, and used for
further reacting this product with packaging food (except for
octadecanoic acid, such that the final food containing more than 8
product has: a maximum acid value of 5 percent alcohol) under
mg KOH/g and total amine value of conditions of use B through H
866 mg KOH/g as determined described in table 2 of Sec.
by a method entitled "Total Amine 176.170(c) of this chapter.
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 Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, or available for inspection
at the Office of the Federal Register,
800 North Capitol Street, NW., suite
700, Washington, DC 20408.
------------------------------------------------------------------------
[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]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3280]
[Page 391]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3280 Castor oil, hydrogenated.
Hydrogenated castor oil may be safely used in the manufacture of
articles or components of articles intended for use in contact with food
subject to the provisions of this section.
(a) The quantity used shall not exceed the amount reasonably
required to accomplish the intended technical effect.
(b) The additive is used as follows:
------------------------------------------------------------------------
Use Limitations
------------------------------------------------------------------------
1. As a lubricant for vinyl chloride For use only at levels not to
polymers used in the manufacture of exceed 4 pct by weight of
articles or components of articles vinyl chloride polymers.
authorized for food-contact use.
2. As a component of cellophane........ Complying with Sec. 177.1200
of this chapter.
3. As a component of resinous and Complying with Sec. 175.300 of
polymeric coatings. this chapter.
4. As a component of paper and Complying with Sec. 176.170 of
paperboard in contact with aqueous and this chapter.
fatty food.
5. As a component of closures with Complying with Sec. 177.1210
sealing gaskets for food containers. of this chapter.
6. As a component of cross-linked Complying with Sec. 177.2420
polyester resins. of this chapter.
7. As a component of olefin polymers For use only at levels not to
complying with Sec. 177.1520 of this exceed 2 percent by weight of
chapter. the polymer.
------------------------------------------------------------------------
[42 FR 14609, Mar. 15, 1977, as amended at 55 FR 8914, Mar. 9, 1990]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3290]
[Page 391]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3290 Chromic chloride complexes.
Myristo chromic chloride complex and stearato chromic chloride
complex may be safely used as release agents in the closure area of
packaging containers intended for use in producing, manufacturing,
packing, processing, preparing, treating, packaging, transporting, or
holding food, subject to the provisions of this section:
(a) The quantity used shall not exceed that reasonably required to
accomplish the intended technical effect nor exceed 7 micrograms of
chromium per square inch of closure area.
(b) The packaging container which has its closure area treated with
the release agent shall have a capacity of not less than 120 grams of
food per square inch of such treated closure area.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3295]
[Page 391-393]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3295 Clarifying agents for polymers.
Clarifying agents may be safely used in polymers that are articles
or components of articles intended for use in
[[Page 392]]
contact with food, subject to the provisions of this section:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Aluminum, hydroxybis[2,4,8,10- For use only as a clarifying
tetrakis(1,1-dimethylethyl)-6-hydroxy- agent at levels not to exceed
12H-dibenzo[d,g][1,3,2]dioxaphosphocin 0.25 percent by weight of
6-oxidato]-(CAS Reg. No. 151841-65-5). polypropylene and
polypropylene copolymers
complying with Sec.
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 Sec.
176.170(c) of this chapter,
under conditions of use B
through H described in Table 2
of Sec. 176.170(c) of this
chapter or foods only of types
III, IV-A, V, VI-A, VI-C, VII-
A, and IX as identified in
Table 1 of Sec. 176.170(c) of
this chapter, under conditions
of use C through G described
in Table 2 of Sec. 176.170(c)
of this chapter.
Bis(p-ethylbenzylidene) sorbitol (CAS For use only as a clarifying
Reg. No. 79072-96-1). agent at a level not to exceed
0.35 percent by weight of
olefin polymers complying with
Sec. 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. For use only as a clarifying
54686-97-4). agent at a level not to exceed
0.32 percent by weight in
propylene homopolymer
complying with Sec.
177.1520(c) of this chapter,
item 1.1, and in olefin
copolymers complying with Sec.
177.1520(c) of this chapter,
item 3.1 (containing at least
85 weight percent of polymer
units derived from propylene),
in contact with all food types
under conditions of use C
through G described in table 2
of Sec. 176.170(c) of this
chapter.
Dibenzylidene sorbitol (CAS Reg. No. For use only as a clarifying
32647-67-9) formed by the condensation agent for olefin polymers
of two moles of benzaldehyde with one complying with Sec.
mole of sorbitol, such that the final 177.1520(c) 1.1, 3.1, and 3.2
product has a minimum content of 95 of this chapter under
percent dibenzylidene sorbitol. conditions of use C, D, E, F,
and G, described in table 2 of
Sec. 176.170(c) of this
chapter at a level not
exceeding 0.25 percent by
weight of the polymer.
Dimethyldibenzylidene sorbitol (CAS For use only as a clarifying
Reg. No. 135861-56-2) agent at a level not to exceed
0.4 percent by weight of
olefin polymers complying with
Sec. 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
contact with food under
conditions of use A through H
described in table 2 of Sec.
176.170(c) of this chapter.
Polyvinylcyclohexane (CAS Reg. No. For use only as a clarfiying
25498-06-0). agent for polypropylene
complying with Sec.
177.1520(c) of this chapter,
item 1.1., and in propylene
containing copolymers
complying with Sec.
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 For use only as a clarifying
(CAS Reg. No. 10491-31-3). agent at a level not exceeding
0.35 parts per hundred of the
resin in olefin polymers
complying with Sec.
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
propylene).
[[Page 393]]
Sodium 2,2'-methylenebis(4,6-di-tert- For use only:
butylphenyl)phosphate (CAS Reg. No. 1. As a clarifying agent at a
85209-91-2). level not exceeding 0.30
percent by weight of olefin
polymers complying with Sec.
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 Sec. 176.170(c) of
this chapter and limited to
conditions of use B through H,
described in table 2 of Sec.
176.170(c), or foods of all
types, limited to conditions
of use C through H described
in table 2 of Sec.
176.170(c).
2. As a clarifying agent at
levels not exceeding 0.10
percent by weight of
polypropylene complying with
Sec. 177.1520(c) of this
chapter, items 1.1(a) or
1.1(b) and of olefin polymers
complying with Sec.
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 Sec.
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 Sec.
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 identified in
Table 1 of Sec. 176.170(c) of
this chapter, and limited to
conditions of use B through H
described in Table 2 of Sec.
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 Sec. 176.170(c)
of this chapter and limited to
conditions of use C through G
described in Table 2 of Sec.
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]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3297]
[Page 393-397]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3297 Colorants for polymers.
The substances listed in paragraph (e) of this section may be safely
used as colorants in the manufacture of articles or components of
articles intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food, subject to the provisions and definitions set forth in this
section:
(a) The term colorant means a dye, pigment, or other substance that
is used to impart color to or to alter the color of a food-contact
material, but that does not migrate to food in amounts that will
contribute to that food any color apparent to the naked eye. For the
purpose of this section, the term "colorant" includes substances such
as optical brighteners and fluorescent whiteners, which may not
themselves be colored, but whose use is intended to affect the color of
a food-contact material.
(b) The colorant must be used in accordance with current good
manufacturing practice, including use levels which are not in excess of
those reasonably required to accomplish the intended coloring effect.
(c) Colorants in this section must conform to the description and
specifications indicated. If a polymer described in this section is
itself the subject of a regulation promulgated under section 409 of the
Federal Food, Drug, and Cosmetic Act, it shall also comply with any
specifications and limitations prescribed by that regulation. Extraction
testing guidelines to conduct studies for additional uses of colorants
under this section are available from the Food and Drug Administration
free of charge from the Center for Food Safety and Applied Nutrition,
(HFS-200) Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740.
[[Page 394]]
(d) Color additives and their lakes listed for direct use in foods,
under the provisions of the color additive regulations in parts 73, 74,
81, and 82 of this chapter, may also be used as colorants for food-
contact polymers.
(e) List of substances:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Aluminum...............................
Aluminum hydrate.......................
Aluminum and potassium silicate (mica).
Aluminum mono-, di-, and tristearate...
Aluminum silicate (China clay).........
4-[[5-[[[4-(Aminocarbonyl) phenyl] For use at levels not to exceed
amino]carbonyl]- 2-methoxyphenyl]azo]- 1 percent by weight of
N-(5-chloro-2,4-dimethoxyphenyl)-3- polymers. The finished
hydroxy-2-naphthalene-carboxamide articles are to contact foods
(C.I. Pigment Red 187, CAS Reg. No. only under conditions of use B
59487-23-9). through H described in table 2
of Sec. 176.170(c) of this
chapter.
N-[4-(Aminocarbonyl)phenyl]-4-[[1- For use at levels not to exceed
[[(2,3-dihydro-2-oxo-1H-benzimidazol-5- 1 percent by weight of
yl)amino]carbonyl]-2- polymers. The finished
oxopropyl]azo]benzamide (C. I. Pigment articles are to contact food
Yellow 181, CAS Reg. No. 74441-05-7). only under conditions of use B
through H described in table 2
of Sec. 176.170(c) of this
chapter.
Anthra(2,1,9-def:(6,5,10- For use at levels not to exceed
d'e'f)diisoquinoline-1,3,8,10(2H,9H)- 1% by weight of polymers. The
tetrone (C.I. Pigment Violet 29; CAS finished articles are to
Reg. No. 81-33-4). contact food only under
conditions of use B through H
as described in Table 2 of
Sec. 176.170(c) of this
chapter.
Barium sulfate.........................
Bentonite..............................
Bentonite, modified with 3-
dimethyldioctadecylammonium ion.
1,4-Bis[(2,4,6-trimethylphenyl)amino]- For use at levels not to exceed
9,10-anthracenedione (CAS Reg. No. 116- 0.0004 percent by weight of
75-6). polyethylene phthalate
polymers complying with Sec.
177.1630 of this chapter.
3,6-Bis(4-chlorophenyl)-2,5-dihydro- For use only at levels not to
pyrrolo[3,4-c]pyrrole-1,4-dione (C.I. exceed 1 percent by weight of
Pigment Red 254, CAS Reg. No. 84632-65- polymers. The finished
5). articles are to contact food
only under conditions of use B
through H, described in table
2 of Sec. 176.170(c) of this
chapter.
4,4'-Bis(4-anilino-6-diethanolamine- For use only in the textile
[alpha]-triazin-2-ylamino)-2,2'- fibers specified in Sec.
stilbene disulfonic acid, disodium 177.2800 of this chapter.
salt.
4,4'-Bis(4-anilino-6-methylethanolamine- Do.
[alpha]-triazin-2-ylamino)-2,2'-
stilbene disulfonic acid, disodium
salt.
Burnt umber............................
Calcium carbonate......................
Calcium silicate.......................
Calcium sulfate........................
Carbon black (channel process, prepared
by the impingement process from
stripped natural gas).
4-Chloro-2-[[5-hydroxy-3-methyl-1-(3- For use at levels not to exceed
sulfophenyl)-1H-pyrazol-4-yl]azo]-5- 1.0 percent by weight of the
methylbenzenesulfonic acid, calcium finished polymers. The
salt (1:1); (C.I. Pigment Yellow 191, finished articles are to
CAS Reg. No. 129423-54-7). contact food only under
conditions of use B through H
as described in table 2 of
Sec. 176.170(c) of this
chapter.
4-Chloro-2-[[5-hydroxy-3-methyl-1-(3- For use at levels not to
sulfophenyl)-1H-pyrazol-4-yl]azo]-5- exceed 0.5 percent by weight
methylbenzenesulfonic acid, diammonium of polymers. The finished
salt (1:2): (C.I. Pigment Yellow articles are to contact food
191:1, CAS Reg. No. 154946-66-4). under conditions of use A
through H described in Table 2
of Sec. 176.170(c) of this
chapter.
Chrome antimony titanium buff rutile For use at levels not to exceed
(C.I. Pigment Brown 24, CAS Reg. No. 1 percent by weight of
68186-90-3). polymers. The finished
articles are to contact food
only under conditions of use B
through H as described in
Table 2 of Sec. 176.170(c) of
this chapter.
Chromium oxide green, Cr2O3 (C.I. For use only:
Pigment Green 17, C.I. No. 77288). 1. In polymers used in contact
with food at a level not to
exceed 5 percent by weight of
the polymer, except as
specified below.
2. In olefin polymers complying
with Sec. 177.1520 of this
chapter.
3. In repeat-use rubber
articles complying with Sec.
177.2600 of this chapter;
total use is not to exceed 10
percent by weight of rubber
articles.
[[Page 395]]
Cobalt aluminate....................... For use only:
1. In resinous and polymeric
coatings complying with Sec.
175.300 of this chapter.
2. Melamine-formaldehyde resins
in molded articles complying
with Sec. 177.1460 of this
chapter.
3. Xylene-formaldehyde resins
condensed with 4-
4'isopropylidenediphenol-
epichlorohydrin epoxy resins
complying with Sec. 175.380
of this chapter.
4. Ethylene-vinyl acetate
copolymers complying with Sec.
177.1350 of this chapter.
5. Urea-formaldehyde resins in
molded articles complying with
Sec. 177.1900 of this
chapter.
6. At levels not to exceed 5
percent by weight of all
polymers except those listed
under limitations 1 through 5
of this item. The finished
articles are to contact food
under conditions of use A
through H described in table 2
of Sec. 176.170(c) of this
chapter.
Copper chromite black spinel (C.I. For use at levels not to exceed
Pigment Black 28, CAS Reg. No. 68186- 5 percent by weight of
91-4). polymers. The finished
articles are to contact food
only under conditions of use A
through H as described in
table 2 of Sec. 176.170(c) of
this chapter.
D&C Red No. 7 and its lakes............
Diatomaceous earth.....................
4,4'-Diamino-[1,1'-bianthracene]- For use at levels not to exceed
9,9',10,10'-tetrone (CAS Reg. No. 4051- 1 percent by weight of
63-2). polymers. The finished
articles are to contact food
only under conditions of use B
through H described in table 2
of Sec. 176.170(c) of this
chapter.
2,9-Dichloro-5,12-dihydroquinone[2,3- For use at levels not to exceed
b]acridine-7,14-dione (C.I. Pigment 1.0 percent by weight of
Red 202, CAS Reg. No. 3089-17-6). polymers.
4,5-Dichloro-2-((5-hydroxy-3-methyl-1- For use only:
(3-sulfophenyl)-1H-pyrazol-4- 1. At levels not to exceed 1
yl)azo)benzenesulfonic acid, calcium percent by weight of
salt(1:1), (C.I. Pigment Yellow 183, polypropylene polymers and
CAS Reg. No. 65212-77-3). copolymers complying with Sec.
177.1520(c) of this chapter,
items 1.1a, 1.1b, 1.2, 1.3,
3.1a, 3.1b, 3.1c, 3.2a, 3.2b,
3.4, or 3.5. The finished
articles are to contact food
only under conditions of use E
through G, as described in
Table 2 of Sec. 176.170(c) of
this chapter.
2. At levels not to exceed 1
percent by weight of high
density polyethylene polymers
and copolymers complying with
Sec. 177.1520(c) of this
chapter, items 2.1, 2.2, 2.3,
3.1a, 3.1b, 3.1c, 3.2a, 3.2b,
3.6 (density not less than
0.94 grams per cubic
centimeter), or 5. The
finished articles are to
contact food only under
conditions of use E through G,
as described in Table 2 of
Sec. 176.170(c) of this
chapter.
5-[(2,3-Dihydro-6-methyl-2-oxo-1H- For use at levels not to exceed
benzimidazol-5-yl)azo]-2,4,6(1H, 3H, 1 percent by weight of
5H)-pyrimidinetrione (CAS Reg. No. polymers. The finished
72102-84-2). articles are to contact food
only under conditions of use B
through H described in table 2
of Sec. 176.170(c) of this
chapter.
2,9-Dimethylanthra(2,1,9-def:6,5,10- For use at levels not to exceed
d'e'f')diisoquinoline-1,3,8,10(2H,9H)- 1 percent by weight of
tetrone (C.I. Pigment Red 179, CAS polymers. The finished
Reg. No. 5521-31-3). articles are to contact food
only under conditions of use B
through H as described in
Table 2 of Sec. 176.170(c) of
this chapter.
3,3'-[(2,5-Dimethyl-1,4- For use at levels not to exceed
phenylene)bis[imino(1-acetyl-2-oxo-2,1- 1 percent by weight of
ethanediyl)azo]]bis[4-chloro-N-(5- polymers. The finished
chloro-2-methylphenyl)-benzamide] (CAS articles are to contact food
Reg. No. 5280-80-8). only under conditions of use B
through H described in table 2
of Sec. 176.170(c) of this
chapter.
3,3'-[(2,5-Dimethyl-1,4- For use at levels not to exceed
phenylene)bis[imino-carbonyl(2-hydroxy- 1 percent by weight of
3,1-naphthalenediyl) azo]] bis(4- polymers. The finished
methylbenzoic acid), bis(2- articles are to contact food
chloroethyl) ester (CAS Reg. No. 68259- only under conditions of use B
05-2). through H described in table 2
of Sec. 176.170(c) of this
chapter.
2,2'-[1,2-Ethanediylbis(oxy-2,1- For use at levels not to exceed
phenyleneazo)]bis[N-(2,3-dihydro-2-oxo- 1.0 percent by weight of
1H-benzimidazol-5-yl)]-3-oxo- polymers. The finished
butanamide (C.I. Pigment Yellow 180, articles are to contact food
CAS Reg. No. 77804-81-0). only under conditions of use B
through G described in table 2
of Sec. 176.170(c) of this
chapter.
2,2'-(1,2-Ethenediyldi-4,1-phenylene) For use as an optical
bis(benzoxazole) (CAS Reg. No. 1533-45- brightener for all polymers at
5). a level not to exceed 0.025
percent by weight of polymer.
The finished polymer shall
contact foods only of the
types identified in table 1 of
Sec. 176.170(c) of this
chapter, under categories I,
II, IV-B, VI-A, VI-B, VII-B,
and VIII at temperatures not
to exceed 275 deg.F.
[[Page 396]]
High-purity furnace black (CAS Reg. No. For use at levels not to exceed
1333-86-4) containing total 2.5 percent by weight of the
polynuclear aromatic hydrocarbons not polymer.
to exceed 0.5 parts per million, and
benzo[a]pyrene not to exceed 5.0 parts
per billion, as determined by a method
entitled "Determination of PAH
Content of Carbon Black," dated July
8, 1994, as developed by the Cabot
Corp., which is incorporated by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies may
be obtained from the Office of
Premarket Approval (HFS-200), Center
for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD
20740, or may be examined at the
Center for Food Safety and Applied
Nutrition's Library, 5100 Paint Branch
Pkwy., College Park, MD 20740, or at
the Office of the Federal Register,
800 North Capitol St. NW., suite 700,
Washington, DC.
Iron oxides............................
Kaolin-modified, produced by treating For use only in olefin polymers
kaolin with a reaction product of complying with Sec. 177.1520
isopropyl titanate and oleic acid in of this chapter at levels not
which 1 mole of isopropyl titanate is to exceed 40 percent by weight
reacted with 1 to 2 moles of oleic of olefin polymer.
acid. The reaction product will not
exceed 8 percent of the modified
kaolin. The oleic acid used shall meet
the requirements specified in Sec.
172.860 of this chapter.
Magnesium oxide........................
Magnesium silicate (talc)..............
Manganese Violet (manganese ammonium For use at levels not to exceed
pyrophosphate; CAS Reg. No. 10101-66- 2 percent by weight of
3).. polymers. The finished
articles are to contact food
only under conditions of use A
through H as described in
table 2 of Sec. 176.170(c) of
this chapter.
Mixed methylated 4,4'-bis(2- For use as an optical
benzoxazolyl)stilbenes with the major brightener only at levels not
portion consisting of 4-(2- to exceed 0.05 percent by
benzoxazolyl)-4'-(5-methyl-2- weight of rigid and semirigid
benzoxazolyl)stilbene (CAS Registry polyvinyl chloride and not to
No. 5242-49-9) and lesser portions exceed 0.03 percent by weight
consisting of 4,4'-bis(5-methyl-2- in all other polymers. The
benzoxazolyl)stilbene (CAS Registry finished food-contact articles
No. 2397-00-4) and 4,4'-bis(2- shall be used only under
benzoxazolyl)stilbene (CAS Registry conditions of use D, E, F, and
No. 1533-45-5). G described in table 2 of Sec.
176.170(c) of this chapter.
7-(2H-Naphtho[1,2-d]triazol-2-yl)-3- For use as an optical
phenylcoumarin (CAS Reg. No. 3333-62- brightener only in:
8) having a melting point of 250 1. Olefin polymers complying
deg.C to 251 deg.C and a nitrogen with Sec. 177.1520 of this
content of 10.7 to 11.2 percent. chapter only at levels such
that the product of
concentration of the optical
brightener (expressed in parts
per million by weight of the
olefin polymer) multiplied by
the thickness of the olefin
polymer (expressed in
thousandths of an inch and
limited to no more than 0.400
inch) shall not exceed 500;
provided that the level of the
brightener shall not exceed 20
parts per million by weight of
the olefin polymer, and
further that the olefin
polymers shall comply with
specifications for items 1.1,
2.1, 3.1, 3.3, and 4 of Sec.
177.1520(c) of this chapter.
The polymer may be used under
the conditions described in
Sec. 176.170(c) of this
chapter, table 2, under
conditions of use E, F, and G.
2. Polyethylene terephthalate
specified in Sec.
177.2800(d)(5)(i) of this
chapter at a level not to
exceed 0.035 percent by weight
of the finished fibers.
Nickel antimony titanium yellow rutile For use at levels not to exceed
(C.I. Pigment Yellow 53, CAS Reg. No. 1 percent by weight of
8007-18-9). polymers. The finished
articles are to contact food
only under conditions of use B
through H as described in
Table 2 of Sec. 176.170(c) of
this chapter.
1,1'-[(6-Phenyl-1,3,5-triazine-2,4- For use at levels not to exceed
diyl)diimino]bis-9,10-anthracenedione 0.25 percent by weight of
(CAS Reg. No. 4118-16-5). polyethylene phthalate
polymers that comply with Sec.
177.1630 of this chapter. The
finished articles are to
contact food only under
conditions of use E, F, and G
described in table 2, Sec.
176.170(c) of this chapter,
except, when such articles are
used with food types III, IV-
A, and V, described in table
1, Sec. 176.170(c) of this
chapter, the finished articles
are to contact food only under
conditions of use D, E, F, and
G.
Phthalocyanine blue (C.I. pigment blue
15, 15:1, 15:2, 15:3, and 15:4; C.I.
No. 74160; CAS Reg. No. 147-14-8).
Phthalocyanine green (C.I. pigment
green 7, C.I. No. 74260).
C.I. Pigment red 38 (C.I. No. 21120)... For use only in rubber articles
for repeated use complying
with Sec. 177.2600 of this
chapter; total use is not to
exceed 10 percent by weight of
rubber article.
Quinacridone red (C.I. Pigment violet
19, C.I. No. 73900).
Sienna (raw and burnt).................
Silica.................................
[[Page 397]]
2,3,4,5-Tetrachloro-6-cyanobenzoic For use only at levels not to
acid, methyl ester reaction products exceed 1 percent by weight of
with p-phenyllenediamine and sodium polymers. The finished
methoxide (CAS reg. No. 106276-80-6). articles are to contact food
only under conditins of use B
through H, described in table
2, of Sec. 176.170(c) of this
chapter.
4,5,6,7-Tetrachloro-2-[2-(4,5,6,7- For use only at levels not to
tetrachloro-2,3-dihydro-1,3-dioxo-1H- exceed 1 percent by weight of
inden-2-yl)-8-quinolinyl]-1H-isoindole- polymers. The finished
1,3(2H)-dione (C. I. Pigment Yellow articles are to contact food
138, CAS Reg. No.30125-47-4). only under conditions of use C
through H, as described in
table 2 of Sec. 176.170(c) of
this chapter; provided further
that the finished articles
shall not be filled at
temperatures exceeding 158
deg.F (70 deg.C).
2,2'-(2,5-Thiophenediyl)-bis(5-tert- For use as an optical
butylbenzoxazole) (CAS Reg. No. 7128- brightener:
64-5). 1. In all polymers at levels
not to exceed 0.015 percent by
weight of the polymer. The
finished articles are to
contact food only under
conditions of use A through H
described in table 2 of Sec.
176.170(c) of this chapter.
2. In all polymers at levels
not to exceed 0.05 percent by
weight of the polymer. The
finished articles shall
contact foods only of the
types identified in table 1 of
Sec. 176.170(c) of this
chapter, under Categories I,
II, IV-B, VI-A, VI-B, VI-C,
VII-B, and VIII under
conditions of use A through H
described in table 2 of Sec.
176.170(c) of this chapter.
3. In adhesives complying with
Sec. 175.105 of this chapter
and in pressure-sensitive
adhesives complying with Sec.
175.125 of this chapter.
Titanium dioxide.......................
Titanium dioxide-barium sulfate........
Titanium dioxide-magnesium silicate....
Ultramarines........................... As identified in Sec. 73.2725
of this chapter.
Zinc carbonate......................... For use only:
1. In resinous and polymeric
coatings complying with Sec.
175.300 of this chapter.
2. Melamineformaldehyde resins
in molded articles complying
with Sec. 177.1460 of this
chapter.
3. Xylene-formaldehyde resins
condensed with 4-4'-
isopropylidene diphenol-
epichlorohydrin epoxy resins
complying with Sec. 175.380
of this chapter.
4. Ethylene-vinyl acetate
copolymers complying with Sec.
177.1350 of this chapter.
5. Urea-formaldehyde resins in
molded articles complying with
Sec. 177.1900 of this
chapter.
Zinc chromate.......................... For use only in rubber articles
for repeated use complying
with Sec. 177.2600 of this
chapter; total use is not to
exceed 10 percent by weight of
rubber article.
Zinc oxide............................. For use only:
1. In resinous and polymeric
coatings complying with Sec.
175.300 of this chapter.
2. Melamine-formaldehyde resins
in molded articles complying
with Sec. 177.1460 of this
chapter.
3. Xylene-formaldehyde resins
condensed with 4-4'-
isopropylidene-diphenol-
epichlorohydrin epoxy resins
complying with Sec. 175.380
of this chapter.
4. Ethylene-vinyl acetate
copolymers complying with Sec.
177.1350 of this chapter.
5. Urea-formaldehyde resins in
molded articles complying with
Sec. 177.1900 of this
chapter.
Zinc sulfide........................... For use at levels not to exceed
10 percent by weight.
------------------------------------------------------------------------
[48 FR 46775, Oct. 14, 1983]
Editorial Note: For Federal Register citations affecting
Sec. 178.3297, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3300]
[Page 397-398]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3300 Corrosion inhibitors used for steel or tinplate.
Corrosion inhibitors may be safely used for steel or tinplate
intended for use in, or to be fabricated as, food containers or food-
processing or handling equipment, subject to the provisions of this
section.
(a) The corrosion inhibitors are prepared from substances identified
in this section and used subject to the limitations prescribed.
(b) The following corrosion inhibitors or adjuvants are used in
amounts not to exceed those reasonably required to
[[Page 398]]
accomplish the intended physical or technical effect:
(1) Corrosion inhibitors (active ingredients) used in packaging
materials for the packaging of steel or tinplate or articles fabricated
therefrom:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Dicyclohexylamine and its salts of fatty
acids derived from animal or vegetable
oil.
Dicyclohexylamine nitrite.................
Morpholine and its salts of fatty acids
derived from animal or vegetable oils.
------------------------------------------------------------------------
(2) Adjuvants employed in the application and use of corrosion
inhibitors:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Propylene glycol..........................
------------------------------------------------------------------------
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3400]
[Page 398-401]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3400 Emulsifiers and/or surface-active agents.
The substances listed in paragraph (c) of this section may be safely
used as emulsifiers and/or surface-active agents in the manufacture of
articles or components of articles intended for use in producing,
manufacturing, packing, processing, preparing, treating, packaging,
transporting, or holding food, subject to the provisions of this
section.
(a) The quantity used shall not exceed the amount reasonably
required to accomplish the intended technical effect; and the quantity
that may become a component of food as a result of such use shall not be
intended to, nor in fact, accomplish any physical or technical effect in
the food itself.
(b) The use as an emulsifier and/or surface-active agent in any
substance or article that is the subject of a regulation in parts 174,
175, 176, 177, 178 and Sec. 179.45 of this chapter conforms with any
specifications and limitations prescribed by such regulation for the
finished form of the substance or article.
(c) List of substances:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
[alpha]-Alkyl-, [alpha]-alkenyl-, and For use only at levels not to
[alpha]-alkylaryl-omega- exceed 0.5 pct by weight of
hydroxypoly(oxyethylene) mixture coatings complying with Sec.
consisting of 30 weight pct of [alpha]- 175.320 of this chapter and
(2,4,6-triisobutylphenyl)-omega- limited to use as an
hydroxypoly(oxyethylene) having an emulsifier for polyhydric
average poly(oxyethylene) content of 7 alcohol diesters used as
moles and 70 weight pct of a 1:1 provided in Sec. 178.3770(b).
weight ratio mixture of [alpha]-(Z)-9- The weight of the finished
octadecenyl-omega- coating shall not exceed 2
hydroxypoly(oxyethylene) having an milligrams per square inch of
average poly(oxyethylene) content of food-contact surface.
18 moles and [alpha]-alkyl(C16-C18)-
omega-hydroxypoly(oxyethylene) having
an average poly(oxyethylene) content
of 18 moles.
n-Alkylbenzenesulfonic acid (alkyl For use only as emulsifiers and/
group consisting of not less than 95 or surface active agents as
percent C10 to C16) and its ammonium, components of nonfood articles
calcium, magnesium, potassium, and complying with Secs. 175.300,
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 Sec. 178.3120.
Alkyl mono- and disulfonic acids, For use only:
sodium salts (produced from n-alkanes 1. As provided in Sec. 176.170
in the range of C10-C18 with not less of this chapter.
than 50 percent C14-C16). 2. At levels not to exceed 2
percent by weight of polyvinyl
chloride and/or vinyl chloride
copolymers complying with Sec.
177.1980 of this chapter.
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 Sec.
176.170(c) of this chapter,
and limited to conditions of
use E, F, and G described in
table 2 of Sec. 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-modified
polystyrene complying with
Sec. 177.1640(c) of this
chapter under conditions of
use B through H described in
table 2 of Sec. 176.170(c) of
this chapter.
[alpha]-Alkyl-omega-
hydroxypoly(oxyethylene) produced by
condensation of 1 mole of C11-C15
straight-chain randomly substitued
secondary alcohols with an average of
7-20 moles of ethylene oxide.
[[Page 399]]
alpha Olefin sulfonate [alkyl group is For use only:
in the range of C10-C18 with not less 1. In acrylonitrile-butadiene
than 50 percent C14-C16], ammonium, copolymers identified in Sec.
calcium, magnesium, potassium, and 177.2600(c)(4)(i) of this
sodium salts. chapter.
2. At levels not to exceed 1
percent by weight of acrylic
coatings complying with Sec.
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 Sec.
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 Sec.
175.300(b)(3)(xv) of this
chapter. The finished polymers
contact food only of the Types
V, VIII, and IX as identified
in table 1 of Sec. 176.170(c)
of this chapter.
4. As provided in Sec. 175.105
of this chapter.
Alpha-sulfo-omega- For use only as an emulsifier
(dodecyloxy)poly(oxyethylene) ammonium at levels not to exceed 0.3
salt (CAS Reg. No. 30174-67-5). percent by weight of styrene-
butadiene copolymer coatings
for paper and paperboard
complying with Sec. 176.170
of this chapter.
Ammonium salt of epoxidized oleic acid, For use only:
produced from epoxidized oleic acid 1. As a polymerization
(predominantly dihydroxystearic and emulsifier at levels not to
acetoxyhydroxystearic acids) meeting exceed 1.5 pct by weight of
the following specifications: Acid vinyl chloride polymers used
number 160-180, saponification number as components of nonfood
210-235, iodine number 2-15, and epoxy articles complying with Secs.
groups 0-0.4 percent. 175.105, 175.300, 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 Sec. 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 Secs. 175.105, 175.300,
176.170, 176.180, and 177.1210
of this chapter.
Butanedioic acid, sulfo-1,4-di-(C9-C11 For use as a surface active
alkyl) ester, ammonium salt (also agent as provided in Secs.
known as butanedioic acid, sulfo-1,4- 175.105, 175.125, 176.170, and
diisodecyl ester, ammonium salt [CAS 176.180 of this chapter.
Reg. No. 144093-88-9])..
[alpha]-Di-sec-butylphenyl-omega-
hydroxypoly(oxyethylene) produced 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 component 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 For use only as an emulsifier
Reg. No. 37294-49-8). at levels not to exceed 5
percent by weight of polymers
intended for use in coatings.
[alpha]-Dodecyl-omega-hydroxpoly
(oxyethylene) mixture of dihydrogen
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.
[alpha]-(p-Dodecylphenyl)-omega-
hydroxypoly (oxyethylene) produced by
the condensation of 1 mole of
dodecylphenol (dodecyl group is a
propylene tetramer 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.
Naphthalene sulfonic acid-formaldehyde For use only:
condensate, sodium salt (CAS Reg. No. 1. At levels not to exceed 10
9084-06-4). micrograms/in2 (0.16 mg/dm2)
in vinylidene chloride
copolymer or homopolymer
coatings applied to films of
propylene polymers complying
with Sec. 177.1520 of this
chapter.
2. At levels not to exceed 14
micrograms/in2 (0.21 mg/dm2)
in vinylidene chloride
copolymer or homopolymer
coatings applied to films of
polyethylene phthalate
polymers complying with Sec.
177.1630 of this chapter.
[[Page 400]]
[alpha]-(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 prescribed in Sec.
178.3400(c) and having an average
poly(oxyethylene) content of 5.5-6.5
moles.
[alpha]-(p-Nonylphenyl)-omega-
hydroxypoly (oxyethylene) mixture of
dihydrogen phosphate and monohydrogen
phosphate esters that have an acid
number (to pH 5.2) of 62-72 and that
are produced by the esterification of
'-(p-nonylphenyl)omega-hydroxypoly
(oxyethylene) complying with the
identity prescribed in Sec.
178.3400(c) and having an average
poly(oxyethylene) content of 9-10
moles.
[alpha]-(p-Nonylphenyl)-omega-
hydroxypoly (oxyethylene) mixture of
dihydrogen phosphate and monohydrogen
phosphate esters that have an acid
number (to pH 5.2) of 98-110 and that
are produced by the esterification of
[alpha]-(p-nonylphenyl)-omega-
hydroxypoly (oxyethylene) complying
with the identity prescribed in Sec.
178.3400(c) and having an average
poly(oxyethylene) content of 45-55
moles.
[alpha]-(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.
[alpha]-(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 For use only at levels not to
sulfosuccinate, disodium salt (CAS exceed 5 percent by weight of
Reg. No. 68954-91-6). total monomers used in the
emulsion polymerization of
polyvinyl acetate, acrylic,
and vinyl/acrylic polymers
intended for use as coatings
for paper and paperboard.
Poly[(methylene-p-nonylphenoxy) For use in coatings at levels
poly(oxypropylene)(4-12 moles) not to exceed 1 mg per square
propanol] of minimum molecular weight foot of food-contact surface.
3500.
Poly(oxypropylene) (45-48 moles) block For use only as a surface-
polymer with poly(oxyethylene). The active agent at levels not to
finished block polymers meet the exceed 0.5 percent by weight
following specifications: Average of polyolefin film or
molecular weight 11,000-18,000; polyolefin coatings. Such
hydroxyl number 6.2-10.2; polyolefin film and polyolefin
[middot]cloud point above 100 deg.C. coatings shall have an average
for 10 pct solution. thickness not to exceed 0.005
inch and shall be limited 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,
oxyethylene 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 Sec. 172.836
of this chapter.
Polysorbate 65 conforming to the
identity prescribed in Sec. 172.838
of this chapter.
Polysorbate 80 conforming to the
identity prescribed in Sec. 172.840
of this chapter.
Polysorbate 85 (polyoxyethylene (20)
sorbitan trioleate) meeting 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.
Saponification number 153-170; and
hydroxyl number 330-360.
[[Page 401]]
Sorbitan monooleate meeting the
following specifications:
Saponification 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 Sec. 172.842
of this chapter.
Sorbitan trioleate meeting the
following specifications:
Saponification No. 170-190; and
hydroxyl No. 55-70.
Sorbitan tristearate meeting the
following specifications:
Saponification No. 176-188; and
hydroxyl No. 66-80.
Sulfosuccinic acid 4-ester with For use only at levels not to
polyethylene glycol dodecyl ether, exceed 5 percent by weight of
disodium salt (CAS Reg. No. 39354-45- total monomers used in the
5). emulsion polymerization of
polyvinyl acetate, acrylic,
and vinyl/acrylic polymers
intended for use as coatings
for paper and paperboard.
Sulfosuccinic acid 4-ester with For use only at levels not to
polyethylene glycol nonylphenyl ether, exceed 5 percent by weight of
disodium salt (alcohol moiety produced the total coating monomers
by condensation of 1 mole nonylphenol used in the emulsion
and an average of 9-10 moles of polymerization of polyvinyl
ethylene oxide) (CAS Reg. No. 9040-38- acetate and vinyl-acrylate
4). copolymers intended for use as
coatings for paper and
paperboard.
[alpha]-[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 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.
Tetrasodium N-(1,2-dicarboxyethyl)-N- For use only as a
octadecyl-sulfosuccinate. polymerization emulsifier for
resins applied to tea-bag
material.
[alpha]-Tridecyl-omega-hydroxypoly
(oxyethylene) mixture of dihydrogen
phosphate and monohydrogen phosphate
esters that have an acid number (to pH
5.2) of 75-85 and that are produced by
the esterification of the condensation
product of one mole of "oxo" process
tridecyl alcohol with 5.5-6.5 moles of
ethylene oxide.
[alpha]-Tridecyl-omega-hydroxypoly
(oxyethyl-ene) mixture of dihydrogen
phosphate and monohydrogen phosphate
esters that have an acid number (to pH
5.2) of 58-70 and that are produced by
the esterification of the condensation
product of one mole of "oxo" process
tridecyl alcohol with 9-10 moles of
ethylene oxide.
------------------------------------------------------------------------
(d) The provisions of this section are not applicable to emulsifiers
and/or surface-active agents listed in Sec. 175.105(c)(5) of this
chapter and used in food-packaging adhesives complying with Sec. 175.105
of this chapter.
[42 FR 14609, Mar. 15, 1977]
Editorial Note: For Federal Register citations affecting
Sec. 178.3400, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3450]
[Page 401]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3450 Esters of stearic and palmitic acids.
The ester stearyl palmitate or palmityl stearate or mixtures thereof
may be safely used as adjuvants in food-packaging materials when used in
accordance with the following prescribed conditions:
(a) They are used or intended for use as plasticizers or lubricants
in polystyrene intended for use in contact with food.
(b) They are added to the formulated polymer prior to extrusion.
(c) The quantity used shall not exceed that required to accomplish
the intended technical effect.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3480]
[Page 401-402]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3480 Fatty alcohols, synthetic.
Synthetic fatty alcohols may be safely used as components of
articles intended for use in contact with food, and in synthesizing food
additives and other substances permitted for use as components of
articles intended for use in contact with food in accordance with the
following prescribed conditions:
(a) The food additive consists of fatty alcohols meeting the
specifications and definition prescribed in Sec. 172.864 of this
chapter, except as provided in paragraph (c) of this section.
(b) It is used or intended for use as follows:
[[Page 402]]
(1) As substitutes for the corresponding naturally derived fatty
alcohols permitted for use as components of articles intended for use in
contact with food by existing regulations in parts 174, 175, 176, 177,
178 and Sec. 179.45 of this chapter: Provided, That the use is in
compliance with any prescribed limitations.
(2) As substitutes for the corresponding naturally derived fatty
alcohols used as intermediates in the synthesis of food additives and
other substances permitted for use as components of food-contact
articles.
(c) Synthetic fatty alcohols identified in paragraph (c)(1) of this
section may contain not more than 0.8 weight percent of total diols as
determined by a method titled "Diols in Monohydroxy Alcohol by
Miniature Thin Layer Chromatography (MTLC)," which is incorporated by
reference. Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(1) Synthetic fatty alcohols. (i) Hexyl, octyl, decyl, lauryl,
myristyl, cetyl, and stearyl alcohols meeting the specifications and
definition prescribed in Sec. 172.864 of this chapter, except that they
may contain not more than 0.8 weight percent total diols.
(ii) Lauryl, myristyl, cetyl, and stearyl alcohols manufactured by
the process described in Sec. 172.864(a)(2) of this chapter such that
lauryl and myristyl alcohols meet the specifications in
Sec. 172.864(a)(1)(i) of this chapter, and cetyl and stearyl alcohols
meet the specifications in Sec. 172.864(a)(1)(ii) of this chapter.
(2) Conditions of use. (i) Synthetic fatty alcohols as substitutes
for the corresponding naturally derived fatty alcohols permitted for use
in compliance with Sec. 178.3910.
(ii) Synthetic lauryl alcohol as a substitute for the naturally
derived lauryl alcohol permitted as an intermediate in the synthesis of
sodium lauryl sulfate used in compliance with Sec. 178.3400.
[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982;
54 FR 24898, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3500]
[Page 402]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3500 Glycerin, synthetic.
Synthetic glycerin may be safely used as a component of articles
intended for use in packaging materials for food, subject to the
provisions of this section:
(a) It is produced by the hydrogenolysis of carbohydrates, and shall
contain not in excess of 0.2 percent by weight of a mixture of
butanetriols.
(b) It is used in a quantity not to exceed that amount reasonably
required to produce its intended physical or technical effect, and in
accordance with any limitations prescribed by applicable regulations in
parts 174, 175, 176, 177, 178 and 179 of this chapter. It shall not be
intended to, nor in fact accomplish, any direct physical or technical
effect in the food itself.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3505]
[Page 402]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3505 Glyceryl tri-(12-acetoxystearate).
Glyceryl tri-(12-acetoxystearate) (CAS Reg. No. 139-43-5) may be
safely used as a component of articles intended for use in producing,
manufacturing, packing, processing, preparing, treating, packaging,
transporting, or holding food, subject to the provisions of this
section.
(a) The additive is applied to the surface of calcium carbonate at a
level not to exceed 1 weight-percent of the total mixture.
(b) The calcium carbonate/glyceryl tri-(12-acetoxystearate) mixture
is used as an adjuvant in polymers in contact with nonfatty foods at a
level not to exceed 20 weight-percent of the polymer.
[50 FR 1503, Jan. 11, 1985]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3520]
[Page 402-403]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3520 Industrial starch-modified.
Industrial starch-modified may be safely used as a component of
articles intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food, subject to the provisions of this section.
[[Page 403]]
(a) Industrial starch-modified is identified as follows:
(1) A food starch-modified or starch or any combination thereof that
has been modified by treatment with one of the reactants hereinafter
specified, in an amount reasonably required to achieve the desired
functional effect but in no event in excess of any limitation
prescribed, with or without subsequent treatment as authorized in
Sec. 172.892 of this chapter.
------------------------------------------------------------------------
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 Industrial starch modified by
chloride, not to exceed 5 pct. this treatment shall be used
only as internal sizing for
paper and paperboard intended
for food packaging.
[beta]-Diethylaminoethyl chloride
hydrochloride, not to exceed 4 pct.
Dimethylaminoethyl methacrylate, not to
exceed 3 pct.
Dimethylol ethylene urea, not to exceed Industrial starch modified by
0.375 pct. 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 Industrial starch modified by
and urea, not to exceed 20 pct. this treatment shall be used
only 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 Sec.
176.170(c) of this chapter.
------------------------------------------------------------------------
(2) A starch irradiated under one of the following conditions to
produce free radicals for subsequent graft polymerization with the
reactants listed in this paragraph (a)(2):
(i) Radiation from a sealed cobalt 60 source, maximum absorbed dose
not to exceed 5.0 megarads.
(ii) An electron beam source at a maximum energy of 7 million
electron volts of ionizing radiation, maximum absorbed dose not to
exceed 5.0 megarads.
------------------------------------------------------------------------
List of reactants Limitations
------------------------------------------------------------------------
Acrylamide and [2-(methacryloyloxy) For use only as a retention aid
ethyl]trimethylammonium methyl and dry strength agent
sulfate, such that the finished employed before the sheet-
industrial starch-modified shall forming operation in the
contain: manufacture of paper and
paperboard intended to contact
food, and used at a level not
to exceed 0.25 pct by weight
of the finished 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 sulfate).
2. Not more than 0.20 pct residual
acrylamide.
3. A minimum nitrogen content of 9.0
pct.
------------------------------------------------------------------------
(b) The following adjuvants may be used as surface-active agents in
the processing of industrial starch-modified:
Polyethylene glycol (400) dilaurate.
Polyethylene glycol (400) monolaurate.
Polyoxyethylene (4) lauryl ether.
(c) To insure safe use of the industrial starch-modified, the label
of the food additive container shall bear the name of the additive
"industrial starch-modified," and in the instance of an industrial
starch-modified which is limited with respect to conditions of use, the
label of the food additive container shall contain a statement of such
limited use.
[42 FR 14609, Mar. 15, 1977, as amended at 42 FR 49453, Sept. 27, 1977]
[[Page 404]]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3530]
[Page 404]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3530 Isoparaffinic petroleum hydrocarbons, synthetic.
Isoparaffinic petroleum hydrocarbons, synthetic, may be safely used
in the production of nonfood articles intended for use in producing,
manufacturing, packing, processing, preparing, treating, packaging,
transporting, or holding food, subject to the provisions of this
section.
(a) The isoparaffinic petroleum hydrocarbons, produced by synthesis
from petroleum gases consist of a mixture of liquid hydrocarbons meeting
the following specifications:
Boiling point 63 deg. -260 deg.C, as determined by ASTM method D86-82,
"Standard Method for Distillation of Petroleum Products," which is
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
Ultraviolet absorbance:
260-319 millimicrons--1.5 maximum.
320-329 millimicrons--0.08 maximum.
330-350 millimicrons--0.05 maximum.
Nonvolatile residue 0.002 gram per 100 milliliters maximum.
Synthetic isoparaffinic petroleum hydrocarbons containing antioxidants
shall meet the specified ultraviolet absorbance limits after correction
for any absorbance due to the antioxidants. The ultraviolet absorbance
shall be determined by the procedure described for application to
mineral oil under "Specifications" on page 66 of the "Journal of the
Association of Official Agricultural Chemists," Vol. 45 (February
1962), which is incorporated by reference, disregarding the last
sentence of that procedure. For hydrocarbons boiling below 121 deg.C,
the nonvolatile residue shall be determined by ASTM method D1353-78,
"Standard Test Method for Nonvolatile Matter in Volatile Solvents for
Use in Paint, Varnish, Lacquer, and Related Products;" for those
boiling above 121 deg.C, ASTM procedure D381-80, "Standard Test Method
for Existent Gum in Fuels by Jet Evaporation," which are incorporated
by reference. Copies may be obtained from the American Society for
Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be
examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(b) Isoparaffinic petroleum hydrocarbons may contain antioxidants
authorized for use in food in an amount not to exceed that reasonably
required to accomplish the intended technical effect.
(c) Isoparaffinic petroleum hydrocarbons are used in the production
of nonfood articles. The quantity used shall not exceed the amount
reasonably required to accomplish the intended technical effect, and the
residual remaining in the finished article shall be the minimum amount
reasonably attainable.
[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982;
49 FR 10112, Mar. 19, 1984]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3570]
[Page 404-406]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3570 Lubricants with incidental food contact.
Lubricants with incidental food contact may be safely used on
machinery used for producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food, subject
to the provisions of this section:
(a) The lubricants are prepared from one or more of the following
substances:
(1) Substances generally recognized as safe for use in food.
(2) Substances used in accordance with the provisions of a prior
sanction or approval.
(3) Substances identified in this paragraph (a)(3).
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
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- For use as a copper deactivator
benzotriazole-1-methanamine (CAS Reg. at a level not to exceed 0.1
No. 94270-86-7). percent by weight of the
lubricant.
BHA....................................
BHT....................................
[alpha]-Butyl-omega- Addition to food not to exceed
hydroxypoly(oxyethylene) 10 parts per million.
poly(oxypropylene) 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
Service Registry No. 9038-95-3.
[[Page 405]]
[alpha]-Butyl-omega- Do.
hydroxypoly(oxypropylene); minimum
molecular 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 For use only as a gelling agent
silicate (CAS Reg. No. 68953-58-2), in mineral oil lubricants at a
which may contain up to 7 percent by level not to exceed 15 percent
weight 1,6-hexanediol (CAS Reg. No. by weight of the mineral oil.
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 Addition to food not to exceed
than 300 centistokes). 1 part per million.
Di (n-octyl) phosphite (CAS Reg. No. For use only as an extreme
1809-14-9). pressure-antiwear adjuvant at
a level not to exceed 0.5
percent by weight of the
lubricant.
Disodium decanedioate (CAS Reg. No. For use only:
17265-14-4). 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 For use only as a surfactant to
mixture consisting of the following improve lubricity in
compounds: lubricating 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
subsequent ethoxylation with 4 to 12
moles of ethylene oxide;.
2. Poly(methylene-p-nonylphenoxy)
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-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- For use at levels not to exceed
imidazole-1-ethanol (CAS Reg. No. 95- 0.5 percent by weight of the
38-5). lubricant.
Hexamethylenebis(3,5-di-tert-butyl-4- For use as an antioxidant at
hydroxyhydrocinnamate) (CAS Reg. No. levels not to exceed 0.5
35074-77-2). percent by weight of the
lubricant.
[alpha]-Hydro-omega-hydroxypoly Addition to food not to exceed
(oxyethylene) poly(oxypropylene) 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- For use as a corrosion
octadecenyl)glycine (CAS Reg. No. 110- inhibitor at levels not to
25-8). exceed 0.5 percent by weight
of the lubricant.
N-phenylbenzenamine, reaction products For use only as an antioxidant
with 2,4,4-trimethylpentene (CAS Reg. at levels not to exceed 0.5
No. 68411-46-1). percent by weight of the
lubricant.
Petrolatum............................. Complying with Sec. 178.3700.
Addition to food not to exceed
10 parts per million.
Phenyl-[alpha]-and/or phenyl-[beta]- For use only, singly or in
naphthylamine. 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 For use only as an adjuvant at
esters, compounds with levels not to exceed 0.5
tetramethylnonylamines and C11-14 percent by weight of the
alkylamines. lubricant.
Phosphoric acid, mono- and diisooctyl For use only as a corrosion
esters, reacted with tert-alkyl and inhibitor or rust preventative
(C12-C14) primary amines (CAS Reg. No. inlubricants at a level not to
68187-67-7). exceed 0.5 percent by weight
of the lubricant.
[[Page 406]]
Phosphorothioic acid, O, O, O-triphenyl For use only as an extreme
ester, tert-butyl derivatives (CAS pressure-antiwear adjuvant at
Reg. No. 192268-65-8). a level not to exceed 0.5
percent by weight of the
lubricant.
Polyurea, having a nitrogen content of For use only as an adjuvant in
9-14 percent based on the dry polyurea mineral oil lubricants at a
weight, produced by reacting tolylene level not to exceed 10 percent
diisocyanate with tall oil fatty acid by weight of the mineral oil.
(C16 and C18) amine and ethylene
diamine in a 2:2:1 molar ratio.
Polybutene (minimum average molecular Addition to food not to exceed
weight 80,000). 10 parts per million.
Polybutene, hydrogenated; complying Do.
with the identity prescribed under
Sec. 178.3740.
Polyethylene........................... Do.
Polyisobutylene (average molecular For use only as a thickening
weight 35,000-140,000 (Flory)). agent in mineral oil
lubricants.
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- For use only as an antioxidant
hydroxyhydro-cinnamate)]methane (CAS in lubricants at a level not
Reg. No. 6683-19-8). to exceed 0.5 percent by
weight of the lubricant.
Thiodiethylenebis (3,5-di-tert-butyl-4- For use as an antioxidant at
hydroxyhydrocinnamate) (CAS Reg. No. levels not to exceed 0.5
41484-35-9). percent by weight of the
lubricant.
Tri[2(or 4)-C9-10-branched For use only as an extreme
alkylphenyl]phosphorothioate (CAS Reg. pressure-antiwear adjuvant at
No. 126019-82-7). levels not to exceed 0.5
percent by weight of the
lubricant.
Triphenyl phosphorothionate (CAS Reg. For use as an adjuvant in
No. 597-82-0). lubricants herein listed at a
level not to exceed 0.5
percent by weight of the
lubricant.
Tris(2,4-di-tert-butylphenyl)phosphite For use only as a stabilizer at
(CAS Reg. NO. 31570-04-4). levels not to exceed 0.5
percent by weight of the
lubricant.
Thiodiethylenebis(3,5-di-tert-butyl-4- For use as an antioxidant at
hydroxy-hydro- cinnamate) (CAS Reg. levels not to exceed 0.5
No. 41484-35-9). percent by weight of the
lubricant.
Zinc sulfide........................... For use at levels not to exceed
10 percent by weight of the
lubricant.
------------------------------------------------------------------------
(b) The lubricants are used on food-processing equipment as a
protective antirust film, as a release agent on gaskets or seals of tank
closures, and as a lubricant for machine parts and equipment in
locations in which there is exposure of the lubricated part to food. The
amount used is the minimum required to accomplish the desired technical
effect on the equipment, and the addition to food of any constituent
identified in this section does not exceed the limitations prescribed.
(c) Any substance employed in the production of the lubricants
described in this section that is the subject of a regulation in parts
174, 175, 176, 177, 178 and Sec. 179.45 of this chapter conforms with
any specification in such regulation.
[42 FR 14609, Mar. 15, 1977]
Editorial Note: For Federal Register citations affecting
Sec. 178.3570, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3600]
[Page 406]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3600 Methyl glucoside-coconut oil ester.
Methyl glucoside-coconut oil ester identified in Sec. 172.816(a) of
this chapter may be safely used as a processing aid (filter aid) in the
manufacture of starch, including industrial starch-modified complying
with Sec. 178.3520, intended for use as a component of articles that
contact food.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3610]
[Page 406-407]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3610 a-Methylstyrene-vinyltoluene resins, hydrogenated.
Hydrogenated [alpha]-methylstyrene-vinyltoluene copolymer resins
having a molar ratio of 1 [alpha]-methylstyrene to 3 vinyltoluene may be
safely used as components of polyolefin film intended for use in contact
with food, subject to the following provisions:
(a) Hydrogenated [alpha]-methylstyrene-vinyltoluene copolymer resins
have a drop-softening point of 125 deg. to 165 deg.C and a maximum
absorptivity of 0.17 liter per gram centimeter at 266 nanometers, as
determined by methods titled "Determination of Softening Point (Drop
Method)" and "Determination of Unsaturation of Resin 1977," which are
incorporated by reference. Copies are available from the Center for Food
Safety and Applied Nutrition (HFS-200), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
[[Page 407]]
(b) The polyolefin film is produced from olefin polymers complying
with Sec. 177.1520 of this chapter, and the average thickness of the
film in the form in which it contacts food does not exceed 0.002 inch.
[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982;
54 FR 24898, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3620]
[Page 407-416]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3620 Mineral oil.
Mineral oil may be safely used as a component of nonfood articles
intended for use in contact with food, subject to the provisions of this
section:
(a) White mineral oil meeting the specifications prescribed in
Sec. 172.878 of this chapter may be used as a component of nonfood
articles provided such use complies with any applicable limitations in
parts 170 through 189 of this chapter. The use of white mineral oil in
or on food itself, including the use of white mineral oil as a
protective coating or release agent for food, is subject to the
provisions of Sec. 172.878 of this chapter.
(b) Technical white mineral oil identified in paragraph (b)(1) of
this section may be used as provided in paragraph (b)(2) of this
section.
(1) Technical white mineral oil consists of specially refined
distillates of virgin petroleum or of specially refined distillates that
are produced synthetically from petroleum gases. Technical white mineral
oil meets the following specifications:
(i) Saybolt color 20 minimum as determined by ASTM method D156-82,
"Standard Test Method for Saybolt Color of Petroleum Products (Saybolt
Chromometer Method)," which is incorporated by reference. Copies may be
obtained from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(ii) Ultraviolet absorbance limits as follows:
------------------------------------------------------------------------
Maximum
absorbance
per
Wavelength (m[mu]) centimeter
optical
pathlength
------------------------------------------------------------------------
280 to 289.................................................. 4.0
290 to 299.................................................. 3.3
300 to 329.................................................. 2.3
330 to 350.................................................. 0.8
------------------------------------------------------------------------
Technical white mineral oil containing antioxidants shall meet the
specified ultraviolet absorbance limits after correction for any
absorbance due to the antioxidants. The ultraviolet absorbance shall be
determined by the procedure described for application to mineral oil
under "Specification" on page 66 of the "Journal of the Association
of Official Agricultural Chemists," Volume 45 (February 1962) (which is
incorporated by reference; copies are available from the Center for Food
Safety and Applied Nutrition (HFS-200), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408), disregarding the last two
sentences of that procedure and substituting therefor the following:
Determine the absorbance of the mineral oil extract in a 10-millimeter
cell in the range from 260-350 m[mu], inclusive, compared to the solvent
control. If the absorbance so measured exceeds 2.0 at any point in range
280-350 m[mu], inclusive, dilute the extract and the solvent control,
respectively, to twice their volume with dimethyl sulfoxide and
remeasure the absorbance. Multiply the remeasured absorbance values by 2
to determine the absorbance of the mineral oil extract per centimeter
optical pathlength.
(2) Technical white mineral oil may be used wherever mineral oil is
permitted for use as a component of nonfood articles complying with
Secs. 175.105, 176.200, 176.210, 177.2260, 177.2600, and 177.2800 of
this chapter and Secs. 178.3570 and 178.3910.
(3) Technical white mineral oil may contain any antioxidant
permitted in food by regulations issued in accordance with section 409
of the Act, in an amount not greater than that required to produce its
intended effect.
(c) Mineral oil identified in paragraph (c)(1) of this section may
be used
[[Page 408]]
as provided in paragraph (c)(2) of this section.
(1) The mineral oil consists of virgin petroleum distillates refined
to meet the following specifications:
(i) Initial boiling point of 450 deg.F minimum.
(ii) Color 5.5 maximum as determined by ASTM method D1500-82,
"Standard Test Method for ASTM Color of Petroleum Products (ASTM Color
Scale)," which is incorporated by reference. The availability of this
incorporation by reference is given in paragraph (b)(1)(i) of this
section.
(iii) Ultraviolet absorbance limits as follows as determined by the
analytical method described in paragraph (c)(3) of this section:
------------------------------------------------------------------------
Maximum
absorbance
per
Wavelength (m[mu]) centimeter
optical
pathlength
------------------------------------------------------------------------
280 to 289.................................................. 0.7
290 to 299.................................................. 0.6
300 to 359.................................................. 0.4
360 to 400.................................................. .09
------------------------------------------------------------------------
(2) The mineral oil may be used wherever mineral oil is permitted
for use as a component of nonfood articles complying with Secs. 175.105
and 176.210 of this chapter and Sec. 178.3910 (for use only in rolling
of metallic foil and sheet stock), Secs. 176.200, 177.2260, 177.2600,
and 177.2800 of this chapter.
(3) The analytical method for determining ultraviolet absorbance
limit is as follows:
general instructions
Because of the sensitivity of the test, the possibility of errors
arising from contamination is great. It is of the greatest importance
that all glassware be scrupulously cleaned to remove all organic matter
such as oil, grease, detergent residues, etc. Examine all glassware,
including stoppers and stopcocks, under ultraviolet light to detect any
residual fluorescent contamination. As a precautionary measure it is
recommended practice to rinse all glassware with purified isooctane
immediately before use. No grease is to be used on stopcocks or joints.
Great care to avoid contamination of oil samples in handling and to
assure absence of any extraneous material arising from inadequate
packaging is essential. Because some of the polynuclear hydrocarbons
sought in this test are very susceptible to photo-oxidation, the entire
procedure is to be carried out under subdued light.
apparatus
Separatory funnels. 250-milliliter, 500-milliliter, 1,000-
milliliter, and preferably 2,000-milliliter capacity, equipped with
tetrafluoroethylene polymer stopcocks.
Reservoir. 500-milliliter capacity, equipped with a 24/40 standard
taper male fitting at the bottom and a suitable ball-joint at the top
for connecting to the nitrogen supply. The male fitting should be
equipped with glass hooks.
Chromatographic tube. 180 millimeters in length, inside diameter to
be 15.7 millimeters 0.1 millimeter, equipped with a coarse,
fritted-glass disc, a tetrafluoroethylene polymer stopcock, and a female
24/40 standard tapered fitting at the opposite end. (Overall length of
the column with the female joint is 235 millimeters.) The female fitting
should be equipped with glass hooks.
Disc. Tetrafluoroethylene polymer 2-inch diameter disk approximately
\3/16\-inch thick with a hole bored in the center to closely fit the
stem of the chromatographic tube.
Suction flask. 250-milliliter or 500-milliliter filter flask.
Condenser. 24/40 joints, fitted with a drying tube, length optional.
Evaporation flask (optional). 250-milliliter or 500-milliliter
capacity all-glass flask equipped with standard taper stopper having
inlet and outlet tubes to permit passage of nitrogen across the surface
of contained liquid to be evaporated.
Spectrophotometric cells. Fused quartz cells, optical path length in
the range of 5,000 centimeter 0.005 centimeter; also for
checking spectrophotometer performance only, optical path length in the
range 1,000 centimeter 0.005 centimeter. With distilled
water in the cells, determine any absorbance differences.
Spectrophotometer. Spectral range 250 millimicrons--400 millimicrons
with spectral slit width of 2 millimicrons or less; under instrument
operating conditions for these absorbance measurements, the
spectrophotometer shall also meet the following performance
requirements:
Absorbance repeatability, 0.01 at 0.4 absorbance.
Absorbance accuracy \1\ 0.05 at 0.4 absorbance.
---------------------------------------------------------------------------
\1\ As determined by procedure using potassium chromate for
reference standard and described in National Bureau of Standards
Circular 484, Spectrophotometry, U.S. Department of Commerce (1949). The
accuracy is to be determined by comparison with the standard values at
290, 345, and 400 millimicrons. Circular 484 is incorporated by
reference. Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
---------------------------------------------------------------------------
[[Page 409]]
Wavelength accuracy, 1.0 millimicron.
Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in
cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.
reagents and materials
Organic solvents. All solvents used throughout the procedure shall
meet the specifications and tests described in this specification. The
isooctane, benzene, acetone, and methyl alcohol designated in the list
following this paragraph shall pass the following test:
To the specified quantity of solvent in a 250-milliliter Erlenmeyer
flask, add 1 milliliter of purified n-hexadecane and evaporate on the
steam bath under a stream of nitrogen (a loose aluminum foil jacket
around the flask will speed evaporation). Discontinue evaporation when
not over 1 milliliter of residue remains. (To the residue from benzene
add a 10-milliliter portion of purified isooctane, reevaporate, and
repeat once to insure complete removal of benzene.)
Alternatively, the evaporation time can be reduced by using the
optional evaporation flask. In this case the solvent and n-hexadecane
are placed in the flask on the steam bath, the tube assembly is
inserted, and a stream of nitrogen is fed through the inlet tube while
the outlet tube is connected to a solvent trap and vacuum line in such a
way as to prevent any flow-back of condensate into the flask.
Dissolve the 1 milliliter of hexadecane residue in isooctane and
make to 25 milliliters volume. Determine the absorbance in the 5-
centimeter path length cells compared to isooctane as reference. The
absorbance of the solution of the solvent residue (except for methyl
alcohol) shall not exceed 0.01 per centimeter path length between 280
and 400 m[mu]. For methyl alcohol this absorbance value shall be 0.00.
Isooctane (2,2,4-trimethylpentane). Use 180 milliliters for the test
described in the preceding paragraph. Purify, if necessary, by passage
through a column of activated silica gel (Grade 12, Davison Chemical
Company, Baltimore, Maryland, or equivalent) about 90 centimeters in
length and 5 centimeters to 8 centimeters in diameter.
Benzene, A.C.S. reagent grade. Use 150 milliliters for the test.
Purify, if necessary, by distillation or otherwise.
Acetone, A.C.S. reagent grade. Use 200 milliliters for the test.
Purify, if necessary, by distillation.
Eluting mixtures:
1. 10 percent benzene in isooctane. Pipet 50 milliliters of benzene
into a 250-milliliter glass-stoppered volumetric flask and adjust to
volume with isooctane, with mixing.
2. 20 percent benzene in isooctane. Pipet 50 milliliters of benzene
into a 250-milliliter glass-stoppered volumetric flask and adjust to
volume with isooctane, with mixing.
3. Acetone-benzene-water mixture. Add 20 milliliters of water to 380
milliliters of acetone and 200 milliliters of benzene, and mix.
n-Hexadecane, 99-percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 25 milliliters with isooctane and determine the absorbance
in a 5-centimeter cell compared to isooctane as reference point between
280 m[mu]-400 m[mu]. The absorbance per centimeter path length shall not
exceed 0.00 in this range. Purify, if necessary, by percolation through
activated silica gel or by distillation.
Methyl alcohol, A.C.S. reagent grade. Use 10.0 milliliters of methyl
alcohol. Purify, if necessary, by distillation.
Dimethyl sulfoxide. Spectrophotometric grade (Crown Zellerbach
Corporation, Camas, Washington, or equivalent). Absorbance (1-centimeter
cell, distilled water reference, sample completely saturated with
nitrogen).
------------------------------------------------------------------------
Absorbance
Wavelength (maximum)
------------------------------------------------------------------------
261.5....................................................... 1.00
270......................................................... .20
275......................................................... .09
280......................................................... .06
300......................................................... .015
------------------------------------------------------------------------
There shall be no irregularities in the absorbance curve within these
wavelengths.
Phosphoric acid. 85 percent A.C.S. reagent grade.
Sodium borohydride. 98 percent.
Magnesium oxide (Sea Sorb 43, Food Machinery Company, Westvaco
Division, distributed by chemical supply firms, or equivalent). Place
100 grams of the magnesium oxide in a large beaker, add 700 milliliters
of distilled water to make a thin slurry, and heat on a steam bath for
30 minutes with intermittent stirring. Stir well initially to insure
that all the adsorbent is completely wetted. Using a Buchner funnel and
a filter paper (Schleicher & Schuell No. 597, or equivalent) of suitable
diameter, filter with suction. Continue suction until water no longer
drips from the funnel. Transfer the adsorbent to a glass trough lined
with aluminum foil (free from rolling oil). Break up the magnesia with a
clean spatula and spread out the adsorbent on the aluminum foil in a
layer about 1 centimeter to 2 centimeters thick. Dry for 24 hours at 160
deg.C 1 deg.C. Pulverize the magnesia with mortar and
pestle. Sieve the pulverized adsorbent between 60-180 mesh. Use the
magnesia retained on the 180-mesh sieve.
[[Page 410]]
Celite 545. Johns Mansville Company, diatomaceous earth, or
equivalent.
Magnesium oxide-Celite 545 mixture (2+1) by weight. Place the
magnesium oxide (60-180 mesh) and the Celite 545 in 2 to 1 proportions,
respectively, by weight in a glass-stoppered flask large enough for
adequate mixing. Shake vigorously for 10 minutes. Transfer the mixture
to a glass trough lined with aluminum foil (free from rolling oil) and
spread it out on a layer about 1 centimeter to 2 centimeters thick.
Reheat the mixture at 160 deg.C 1 deg.C for 2 hours, and
store in a tightly closed flask.
Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in
granular form. For each bottle of sodium sulfate reagent used, establish
as follows the necessary sodium sulfate prewash to provide such filters
required in the method: Place approximately 35 grams of anhydrous sodium
sulfate in a 30-milliliter course, fritted-glass funnel or in a 65-
millimeter filter funnel with glass wool plug; wash with successive 15-
milliliter portions of the indicated solvent until a 15-milliliter
portion of the wash shows 0.00 absorbance per centimeter path length
between 280 m[mu] and 400 m[mu] when tested as prescribed under
"Organic solvents." Usually three portions of wash solvent are
sufficient.
Before proceeding with analysis of a sample, determine the
absorbance in a 5-centimeter path cell between 250 millimicrons and 400
millimicrons for the reagent blank by carrying out the procedure,
without an oil sample, recording the spectra after the extraction stage
and after the complete procedure as prescribed. The absorbance per
centimeter pathlength following the extraction stage should not exceed
0.02 in the wavelength range from 280 m[mu] to 400 m[mu]; the absorbance
per centimeter pathlength following the complete procedure should not
exceed 0.02 in the wavelength range from 280 m[mu] to 400 m[mu]. If in
either spectrum the characteristic benzene peaks in the 250 m[mu]-260
m[mu] region are present, remove the benzene by the procedure under
"Organic solvents" and record absorbance again.
Place 300 milliliters of dimethyl sulfoxide in a 1-liter separatory
funnel and add 75 milliliters of phosphoric acid. Mix the contents of
the funnel and allow to stand for 10 minutes. (The reaction between the
sulfoxide and the acid is exothermic. Release pressure after mixing,
then keep funnel stoppered.) Add 150 milliliters of isooctane and shake
to pre-equilibrate the solvents. Draw off the individual layers and
store in glass-stoppered flasks.
Weigh a 20-gram sample of the oil and transfer to a 500-milliliter
separatory funnel containing 100 milliliters of pre-equilibrated
sulfoxide-phosphoric acid mixture. Complete the transfer of the sample
with small portions of preequilibrated isooctane to give a total volume
of the oil and solvent of 75 milliliters. Shake the funnel vigorously
for 2 minutes. Set up three 250-milliliter separatory funnels with each
containing 30 milliliters of pre-equilibrated isooctane. After
separation of liquid phases, carefully draw off lower layer into the
first 250-milliliter separatory funnel and wash in tandem with the 30-
milliliter portions of isooctane contained in the 250-milliliter
separatory funnels. Shaking time for each wash is 1 minute. Repeat the
extraction operation with two additional portions of the sulfoxide-acid
mixture and wash each extractive in tandem through the same three
portions of isooctane.
Collect the successive extractives (300 milliliters total) in a
separatory funnel (preferably 2-liter) containing 480 milliliters of
distilled water; mix, and allow to cool for a few minutes after the last
extractive has been added. Add 80 milliliters of isooctane to the
solution and extract by shaking the funnel vigorously for 2 minutes.
Draw off the lower aqueous layer into a second separatory funnel
(preferably 2-liter) and repeat the extraction with 80 milliliters of
isooctane. Draw off and discard the aqueous layer. Wash each of the 80-
milliliter extractives three times with 100-milliliter portions of
distilled water. Shaking time for each wash is 1 minute. Discard the
aqueous layers. Filter the first extractive through anhydrous sodium
sulfate prewashed with isooctane (see Sodium sulfate under "Reagents
and Materials" for preparation of filter) into a 250-milliliter
Erlenmeyer flask (or optionally into the evaporation flask). Wash the
first separatory funnel with the second 80-milliliter isooctane
extractive and pass through the sodium sulfate. Then wash the second and
first separatory funnels successively with a 20-milliliter portion of
isooctane and pass the solvent through the sodium sulfate into the
flask. Add 1 milliliter of n-hexadecane and evaporate the isooctane on
the steam bath under nitrogen. Discontinue evaporation when not over 1
milliliter of residue remains. To the residue, add a 10-milliliter
portion of isooctane, reevaporate to 1 milliliter of hexadecane, and
repeat this operation once.
Quantitatively transfer the residue with isooctane to a 200-
milliliter volumetric flask, make to volume, and mix. Determine the
absorbance of the solution in the 1-centimeter pathlength cells compared
to isooctane as reference between 280 m[mu]-400 m[mu] (take care to lose
none of the solution in filling the sample cell). Correct the absorbance
values for any absorbance derived from reagents as determined by
carrying out the procedure without an oil sample. If the corrected
absorbance does not exceed the limits prescribed in this paragraph, the
oil meets the ultraviolet absorbance specifications. If the corrected
absorbance per centimeter pathlength exceeds the limits prescribed in
[[Page 411]]
this paragraph, proceed as follows: Quantitatively transfer the
isooctane solution to a 125-milliliter flask equipped with 24/40 joint,
and evaporate the isooctane on the steam bath under a stream of nitrogen
to a volume of 1 milliliter of hexadecane. Add 10 milliliters of methyl
alcohol and approximately 0.3 gram of sodium borohydride. (Minimize
exposure of the borohydride to the atmosphere. A measuring dipper may be
used.) Immediately fit a water-cooled condenser equipped with a 24/40
joint and with a drying tube into the flask, mix until the borohydride
is dissolved, and allow to stand for 30 minutes at room temperature,
with intermittent swirling. At the end of this period, disconnect the
flask and evaporate the methyl alcohol on the steam bath under nitrogen
until the sodium borohydride begins to come out of the solution. Then
add 10 milliliters of isooctane and evaporate to a volume of about 2-3
milliliters. Again, add 10 milliliters of isooctane and concentrate to a
volume of approximately 5 milliliters. Swirl the flask repeatedly to
assure adequate washing of the sodium borohydride residues.
Fit the tetrafluoroethylene polymer disc on the upper part of the
stem of the chromatographic tube, then place the tube with the disc on
the suction flask and apply the vacuum (approximately 135 millimeters Hg
pressure). Weigh out 14 grams of the 2:1 magnesium oxide-Celite 545
mixture and pour the adsorbent mixture into the chromatographic tube in
approximately 3-centimeter layers. After the addition of each layer,
level off the top of the adsorbent with a flat glass rod or metal
plunger by pressing down firmly until the adsorbent is well packed.
Loosen the topmost few millimeters of each adsorbent layer with the end
of a metal rod before the addition of the next layer. Continue packing
in this manner until all the 14 grams of the adsorbent is added to the
tube. Level off the top of the adsorbent by pressing down firmly with a
flat glass rod or metal plunger to make the depth of the adsorbent bed
approximately 12.5 centimeters in depth. Turn off the vacuum and remove
the suction flask. Fit the 500-milliliter reservoir onto the top of the
chromatographic column and prewet the column by passing 100 milliliters
of isooctane through the column. Adjust the nitrogen pressure so that
the rate of descent of the isooctane coming off the column is between 2-
3 milliliters per minute. Discontinue pressure just before the last of
the isooctane reaches the level of the adsorbent. (Caution: Do not allow
the liquid level to recede below the adsorbent level at any time.)
Remove the reservoir and decant the 5-milliliter isooctane concentrate
solution onto the column and with slight pressure again allow the liquid
level to recede to barely above the adsorbent level. Rapidly complete
the transfer similarly with two 5-milliliter portions of isooctane,
swirling the flask repeatedly each time to assure adequate washing of
the residue. Just before the final 5-milliliter wash reaches the top of
the adsorbent, add 100 milliliters of isooctane to the reservoir and
continue the percolation at the 2-3 milliliters per minute rate. Just
before the last of the isooctane reaches the adsorbent level, add 100
milliliters of 10 percent benzene in isooctane to the reservoir and
continue the percolation at the aforementioned rate. Just before the
solvent mixture reaches adsorbent level, add 25 milliliters of 20
percent benzene in isooctane to the reservoir and continue the
percolation at 2-3 milliliters per minute until all this solvent mixture
has been removed from the column. Discard all the elution solvents
collected up to this point. Add 300 milliliters of the acetone-benzene-
water mixture to the reservoir and percolate through the column to
eluate the polynuclear compounds. Collect the eluate in a clean 1-liter
separatory funnel. Allow the column to drain until most of the solvent
mixture is removed. Wash the eluate three times with 300-milliliter
portions of distilled water, shaking well for each wash. (The addition
of small amounts of sodium chloride facilitates separation.) Discard the
aqueous layer after each wash. After the final separation, filter the
residual benzene through anhydrous sodium sulfate pre-washed with
benzene (see Sodium sulfate under "Reagents and Materials" for
preparation of filter) into a 250-milliliter Erlenmeyer flask (or
optionally into the evaporation flask). Wash the separatory funnel with
two additional 20-milliliter portions of benzene which are also filtered
through the sodium sulfate. Add 1 milliliter of n-hexadecane and
completely remove the benzene by evaporation under nitrogen, using the
special procedure to eliminate benzene as previously described under
"Organic solvents." Quantitatively transfer the residue with isooctane
to a 200-milliliter volumetric flask and adjust to volume. Determine the
absorbance of the solution in the 1-centimeter pathlength cells compared
to isooctane as reference between 250 m[mu]-400 m[mu]. Correct for any
absorbance derived from the reagents as determined by carrying out the
procedure without an oil sample. If either spectrum shows the
characteristic benzene peaks in the 250 m[mu]-260 m[mu] region,
evaporate the solution to remove benzene by the procedure under
"Organic solvents." Dissolve the residue, transfer quantitatively, and
adjust to volume in isooctane in a 200-milliliter volumetric flask.
Record the absorbance again. If the corrected absorbance does not exceed
the limits proposed in this paragraph, the oil meets the proposed
ultraviolet absorbance specifications.
(d) Mineral oil identified in paragraph (d)(1) of this section may
be used
[[Page 412]]
as provided in paragraph (d)(2) of this section.
(1) The mineral oil consists of virgin petroleum distillates refined
to meet the following specifications:
(i) Distillation endpoint at 760 millimeters pressure not to exceed
371 deg.C, with a maximum residue not to exceed 2 percent, as
determined by ASTM method D86-82, "Standard Method for Distillation of
Petroleum Products," which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(b)(1)(i) of this section.
(ii) Ultraviolet absorbance limits as follows as determined by the
method described in paragraph (d)(3) of this section.
------------------------------------------------------------------------
Maximum
absorb-
ance per
Wavelength (m[mu]) centimeter
optical
pathlength
------------------------------------------------------------------------
280 to 299.................................................. 2.3
300 to 319.................................................. 1.2
320 to 359.................................................. .8
360 to 400.................................................. .3
------------------------------------------------------------------------
(iii) Pyrene content not to exceed a maximum of 25 parts per million
as determined by the method described in paragraph (d)(3) of this
section.
(2) The mineral oil may be used only in the processing of jute fiber
employed in the production of textile bags intended for use in contact
with the following types of food: Dry grains and dry seeds (for example,
beans, peas, rice, and lentils); whole root crop vegetables of the types
identified in 40 CFR 180.34(f); unshelled and shelled nuts (including
peanuts); and dry animal feed. The finished processed jute fiber shall
contain no more than 6 percent by weight of residual mineral oil.
(3) The analytical method for determining ultraviolet absorbance
limits and pyrene content is as follows:
I. Apparatus. A. Assorted beakers, separatory funnels fitted with
tetrafluoroethylene polymer stopcocks, and graduated cylinders.
B. Volumetric flasks, 200-milliliter.
C. A chromatographic column made from nominal 1.3 centimeters
outside diameter x 75 centimeters glass tubing tapered at one end and
joined to a 2-millimeter-bore tetrafluoroethylene polymer stopcock. The
opposite end is flanged and joined to a female 24/40 standard taper
fitting. This provides for accommodating the 500-milliliter reservoir
described in item I.E below.
D. A chromatographic column made from nominal 1.7 centimeters
outside diameter x 115 centimeters glass tubing tapered at one end and
joined to a 2-millimeter-bore tetrafluoroethylene polymer stopcock. The
opposite end is flanged and joined to a 2.5 centimeters outside diameter
x 9.0 centimeters glass tube having a female 24/40 standard taper
fitting. This provides for accommodating the 500-milliliter reservoir
described in item I. E below.
E. A 500-milliliter reservoir having a 24/40 standard taper male
fitting at bottom and a suitable ball joint at the top for connecting to
the nitrogen supply. The female fitting of the chromatographic columns
described in items I. C and D above and the male fitting of the
reservoir described in this item E should both be equipped with glass
hooks.
(Note: Rubber stoppers are not to be used. Stopcock grease is not to
be used on ground-glass joints in this method.)
F. A spectrophotometer equipped to automatically record absorbance
of liquid samples in 1-centimeter pathlength cells in the spectral
region of 280-400 m[mu] with a spectral slit width of 2 m[mu] or less.
At an absorbance level of about 0.4, absorbance measurements shall be
repeatable within 0.01 and accurate within 0.05.
Wavelength measurements shall be repeatable with 0.2 m[mu]
and accurate within 1.0 m[mu]. Instrument operating
conditions are selected to realize this performance under dynamic
(automatic) recording operations. Accuracy of absorbance measurements
are determined at 290, 345, and 400 m[mu], using potassium chromate as
the reference standard. (National Bureau of Standards Circular 484,
Spectrophotometry, U.S. Department of Commerce, 1949.)
G. Two fused quartz cells having pathlengths of
1.000.005 centimeter or better.
II. Purity of reagents and materials. Reagent-grade chemicals shall
be used in all tests. It is further specified that each chemical shall
be tested for purity in accordance with the instruction given under
"Reagents and Materials" in III below. In addition, a blank run by the
procedure shall be made on each purified lot of reagents and materials.
Unless otherwise indicated, references to water shall be understood to
mean distilled water.
III. Reagents and materials-- A. Organic solvents. All solvents used
throughout the procedure shall meet the specifications and tests
described in this section III. The isooctane, benzene, cyclohexane,
nitromethane, and n-hexadecane designated shall pass the following test:
To the specified quantity of solvent in a 150-milliliter beaker, add 1
milliliter of purified n-hexadecane and evaporate
[[Page 413]]
on the steam bath under a stream of nitrogen. Discontinue evaporation
when not over 1 milliliter of residue remains (to the residue from
benzene and nitromethane add a 10-milliliter portion of purified
isooctane, re-evaporate, and repeat once to insure complete removal of
solvent). Dissolve the 1 milliliter of n-hexadecane residue in isooctane
and make to 10-milliliter volume. Determine the absorbance in 1.0-
centimeter pathlength cells compared to water as reference. The
absorbance of the solution of solvent residue shall not exceed 0.05
between 280 and 400 m[mu].
1. Isooctane (2,2,4-trimethylpentane). Use 240 milliliters for the
above test. Purify, if necessary, by passage through a column of
activated silica gel.
2. Benzene. Use 200 milliliters for the above test. Purify, if
necessary, by distillation or otherwise.
3. Cyclohexane. Use 70 milliliters for the above test. Purify, if
necessary, by distillation, silica gel percolation, or otherwise.
4. Nitromethane. Use 125 milliliters for the above test. Purify, if
necessary, by distillation or otherwise.
5. n-Hexadecane. Determine the absorbance on this solvent directly.
Purify, if necessary, by silica gel percolation or otherwise.
B. Other materials--1. Pyrene standard reference. Pyrene, reagent
grade, melting point range 150-152 deg.C. (Organic Chemical 3627,
Eastman Kodak Co., Rochester, N.Y., or equivalent). The standard
reference absorbance is the absorbance at 334 millimicrons of a standard
reference solution of pyrene containing a concentration of 1.0 milligram
per liter in purified isooctane measured against isooctane of the same
spectral purity in 1.0-centimeter cells. (This absorbance will be
approximately 0.28.)
2. Chrysene solution. Prepare a solution at a concentration of 5.0
milligrams per liter by dissolving 5.0 milligrams of chrysene in
purified isooctane in a 1-liter volumetric flask. Adjust to volume with
isooctane.
3. Nitrogen gas. Water pumped or equivalent purity, cylinder with
regulator, and valve control flow at 5 p.s.i.
4. Silica gel. 100-200 mesh (Davison Chemical, Baltimore, Md., Grade
923, or equivalent), purified and activated by the following procedure:
Place about 1 kilogram of silica gel in a large column and wash with
contaminant-free benzene until a 200-milliliter sample of the benzene
coming off the column will pass the ultraviolet absorption test for
benzene. This test is performed as stipulated under "Organic solvents"
in A under III above. When the silica gel has been sufficiently cleaned,
activate the gel before use by placing the 1-kilogram batch in a shallow
container in a layer no greater than 1 inch in depth and heating in an
oven (Caution! Explosion Hazard) at 130 deg.C. for 16 hours, and store
in a vacuum desiccator. Reheating about once a week is necessary if the
silica gel is repeatedly removed from the desiccator.
5. Aluminum oxide (Aluminum Co. of America, Grade F-20, or
equivalent grade). 80-200 mesh, purified and activated by the following
procedure: Place about 1 kilogram of aluminum oxide in a large column
and wash with contaminant-free benzene until a 200-milliliter sample of
the benzene coming off the column will pass the ultraviolet absorption
test for benzene. This test is performed as stipulated under "Organic
solvents" in A under III above. (Caution! Remove Benzene From Adsorbent
Under Vacuum To Minimize Explosion Hazard in Subsequent Heating!) When
the aluminum oxide has been sufficiently cleaned and freed of solvent,
activate it before use by placing the 1-kilogram batch in a shallow
container in a layer no greater than 1 inch in depth. Heat in an oven at
130 deg.C for 16 hours. Upon removal from heat, store at atmospheric
pressure over 80 percent (by weight) sulfuric acid in a desiccator for
at least 36 hours before use. This gives aluminum oxide with between 6
to 9.5 percent volatiles. This is determined by heating a weighed sample
of the prepared aluminum oxide at 2,000 deg.F for 2 hours and then
quickly reweighing. To insure the proper adsorptive properties of the
aluminum oxide, perform the following test:
a. Weigh 50 grams 1 gram of the activated aluminum oxide
and pack into the chromatographic column (1.3 centimeters x 75
centimeters) described under "Apparatus" in C under I above. Use glass
wool at the column exit to prevent the aluminum oxide from passing
through the column.
b. Place a 250-milliliter graduated cylinder under the column to
measure the amount of eluate coming from the column.
c. Prewet the aluminum oxide by passing 40 milliliters of isooctane
through the column. Adjust the nitrogen pressure so that the rate of
descent of the isooctane coming off the column is between 1.5 to 2.5
milliliters per minute.
d. Just prior to the last of the isooctane reaching the top of the
aluminum oxide bed, add 10 milliliters of the isooctane solution
containing 5.0 milligrams of chrysene per liter.
e. Continue percolation until the isooctane is just above the
aluminum oxide. Then add 200 milliliters of a mixture of benzene and
isooctane (33\1/3\ percent benzene and 66\2/3\ percent isooctane by
volume) to the reservoir and continue percolation.
f. Continue percolation, collecting the eluates (40 milliliters of
the prewet solution, 10 milliliters of the sample solution, and 200
milliliters of the gradient solution) in the 250-milliliter graduated
cylinder until the level of the gradient solution is just above the
aluminum oxide. Add 200 milliliters of the eluting solution of benzene
and isooctane (90 percent benzene and 10 percent isooctane
[[Page 414]]
by volume) to the column and continue collecting until a total of 250
milliliters of solution has been obtained. This may be discarded. Now
begin to collect the final eluate.
g. Place a 100-milliliter graduated cylinder under the column and
continue the percolation until a 100-milliliter eluate has been
obtained.
h. Measure the amount of chrysene in this 100-milliliter fraction by
ultraviolet analysis. If the aluminum oxide is satisfactory, more than
80 percent of the original amount of chrysene should be found in this
fraction. (Note: If the amount of chrysene recovered is less than 80
percent, the original batch of aluminum oxide should be sieved between
100-160 mesh. Activation and testing of this sieved batch should
indicate a satisfactory aluminum oxide for use.)
IV. Sampling. Precautions must be taken to insure that an
uncontaminated sample of the mineral oil is obtained since ultraviolet
absorption is very sensitive to small amounts of extraneous material
contaminating the sample through careless handling.
V. Procedure. A. Blank. Before proceeding with the analysis of a
sample, determine the absorbance of the solvent residues by carrying out
the procedure without a sample.
B. Sample. 1. Weigh out 20.0 grams 0.1 gram of the
mineral oil into a beaker and transfer to a 250-milliliter separatory
funnel fitted with a tetrafluoroethylene polymer stopcock, using enough
cyclohexane (25 milliliters) to give a final total volume of 50
milliliters (mineral oil plus cyclohexane).
2. Add 25 milliliters of nitromethane saturated with cyclohexane and
shake by hand vigorously for 3 minutes. Recover the lower nitromethane
layer in a 150-milliliter beaker containing 1 milliliter of n-hexadecane
and evaporate on the steam bath under nitrogen. Repeat the extraction
four more times, recovering each extract in the 150-milliliter beaker.
Exercise care not to fill the beaker to such a capacity that solvent
losses may occur. Evaporate the combined nitromethane extracts to 1
milliliter of n-hexadecane residue containing the nitromethane-soluble
mineral oil extractives. (Note: Complete removal of the nitromethane is
essential. This can be assured by two successive additions of 5
milliliters of isooctane and reevaporation.)
3. Remove the beaker from the steam bath and allow to cool.
4. Weigh 50 grams 1 gram of activated aluminum oxide and
pack into the chromatographic column (1.3 centimeters x 75 centimeters)
described under "Apparatus" in C under I above. (Note: A small plug of
glass wool is placed at the column exit to prevent the aluminum oxide
from passing through the column. After adding aluminum oxide, tap the
column lightly to remove air voids. All percolations using aluminum
oxide are performed under nitrogen pressure. The 500-milliliter
reservoir described under "Apparatus" in E under I above is to be used
to hold the elution solvents.)
5. Prewet the column by adding 40 milliliters of isooctane to the
column. Adjust nitrogen pressure so that rate of descent of the
isooctane coming off the column is 2.0 to 3.0 milliliters per minute. Be
careful to maintain the level of solvent in the reservoir to prevent air
from entering the aluminum oxide bed. New or additional solvent is added
just before the last portion of the previous solvent enters the bed. To
minimize possible photo-oxidation effects, the following procedures
(steps 6 through 18) shall be carried out in subdued light.
6. Before the last of the isooctane reaches the top of the aluminum
oxide bed, release the nitrogen pressure and turn off the stopcock on
the column. Transfer the n-hexadecane residue from the 150-milliliter
beaker from procedure step 3 above onto the column, using several washes
of isooctane (total volume of washes should be no greater than 10-15
milliliters).
7. Open the stopcock and continue percolation until the isooctane is
about 1 centimeter above the top of the aluminum oxide bed. Add 200
milliliters of isooctane to the reservoir, and continue the percolation
at the specified rate.
8. Just before the isooctane surface reaches the top of the aluminum
oxide bed, add 200 milliliters of a mixture of benzene and isooctane
(33\1/3\ percent benzene and 66\2/3\ percent isooctane by volume) to the
reservoir, and continue the percolation.
9. Just before the surface of this mixture reaches the top of the
aluminum oxide bed, release the nitrogen pressure, turn off the
stopcock, and discard all the elution solvents collected up to this
point.
10. Add to the reservoir 300 milliliters of a mixture of benzene and
isooctane (90 percent benzene and 10 percent isooctane by volume), place
a 25-milliliter graduated cylinder under the column, continue the
percolation until 20 milliliters of eluate has been collected, and then
discard the eluate.
11. At this point, place a clean 250-milliliter Erlenmeyer flask
under the column. Continue the percolation and collect all the remaining
eluate.
(Note: Allow the column to drain completely. An increase in the
nitrogen pressure may be necessary as the last of the solvent comes off
the column.)
12. Place 1 milliliter of n-hexadecane into a 150-milliliter beaker.
Place this onto a steam bath under a nitrogen stream and transfer in
small portions the eluate from step 11 above. Wash out the Erlenmeyer
flask with small amounts of benzene and transfer to the evaporation
beaker. Evaporate until only 1 milliliter of hexadecane residue remains.
(Note: Complete removal of the benzene is essential. This can be assured
by two successive
[[Page 415]]
additions of 5 milliliters of isooctane and reevaporation.)
13. Remove the beaker from the steam bath and cool.
14. Place a sample of 113.5 grams activated 100- 200-mesh silica gel
in a 500-milliliter glass-stoppered Erlenmeyer flask. Add to the silica
gel 46.2 grams (41 milliliters) of nitromethane. Stopper and shake the
flask vigorously until no lumps of silica gel are observed and then
shake occasionally during a period of 1 hour. The resultant
nitromethane-treated silica gel is 29 weight-percent nitro-methane and
71 weight-percent silica gel.
15. Place a small plug of glass wool in the tapered end of the 1.7
centimeters outside diameter x 115 centimeters column, described under
"Apparatus" in D of I above, adjacent to the stopcock to prevent
silica gel from passing through the stopcock. Pack the nitromethane-
treated silica gel into the column, tapping lightly. The resultant
silica gel bed should be about 95 centimeters in depth. Place into a
flask 170 milliliters of isooctane saturated with nitromethane.
16. Place a 100-milliliter graduated cylinder under the column and
transfer the residue from the beaker in procedure step 13 above with
several washes of the 170 milliliters of isooctane, saturated with
nitromethane, onto the top of the column. (Total volume of washes should
be no greater than 10 to 15 milliliters.) Permit isooctane solution to
enter the silica gel bed until the liquid level is at the top bed level.
Place the remaining amount of the 170 milliliters of isooctane,
saturated with nitromethane, in the reservoir above the bed for
percolation through the silica gel. Apply nitrogen pressure to the top
of the column, adjusting the pressure so that the isooctane is collected
at the rate of 2.5 to 3.5 milliliters per minute, and percolate
isooctane through the bed until a quantity of 75.0 milliliters of eluate
is collected. Discard the 75 milliliters of eluate. Turn off the
stopcock and add 250 milliliters of benzene to the reservoir above the
bed. Use a 400-milliliter beaker to collect the remaining eluate.
17. Open the stopcock, renew the pressure, and percolate the
remaining isooctane and benzene through the column eluting the remaining
aromatics. Transfer the eluate in small portions from the 400 milliliter
beaker to a 150-milliliter beaker containing 1 milliliter of n-
hexadecane and evaporate on the steam bath under nitrogen. Rinse the
400-milliliter beaker well with small portions of isooctane to obtain a
complete transfer.
(Note: Complete removal of the nitromethane and benzene is
essential. This can be assured by successive additions of 5 milliliters
of isooctane and reevaporation.)
18. Transfer the residue with several washes of isooctane into a
200-milliliter volumetric flask. Add isooctane to mark.
19. Record the spectrum of the sample solution in a 1-centimeter
cell compared to isooctane from 270 to 400 m[mu]. After making necessary
corrections in the spectrum for cell differences and for the blank
absorbance, record the maximum absorbance in each of the wavelength
intervals (m[mu]), 280-299, 300-319, 320-359, 360-400.
a. If the spectrum then shows no discernible peak corresponding to
the absorbance maximum of the pyrene reference standard solution at 334
m[mu], the maximum absorbances in the respective wavelength intervals
recorded shall not exceed those prescribed in paragraph (d)(1)(ii) of
this section.
b. If such a peak is evident in the spectrum of the sample solution,
and the spectrum as a whole is not incompatible with that of a pyrene
contaminant yielding such a peak of the observed absorbance, calculate
the concentration of pyrene that would yield this peak (334 m) by the
base-line technique described in ASTM method E169-63 (Reapproved 1981),
"Standard Recommended Practices for General Techniques of Ultraviolet
Quantitative Analysis," which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(b)(1)(i) of this section. Correct each of the maximum absorbances in
the respective specified wavelength intervals by subtracting the
absorbance due to pyrene, determined as follows:
[GRAPHIC] [TIFF OMITTED] TR01JA93.407
where:
Cp=Calculated concentration of pyrene in sample solution;
Sp=Concentration of pyrene reference standard solution in same units of
concentration;
Sa=Absorbance of pyrene reference standard solution at wavelength of
maximum absorbance of sample solution in the respective specified
wavelength intervals.
Also calculate the pyrene content of the oil sample in parts per
million as follows:
[GRAPHIC] [TIFF OMITTED] TR01JA93.408
where:
C=Calculated concentration of pyrene in milligrams per liter of sample
solution.
c. The pyrene content so determined shall not exceed 25 p.p.m. The
maximum absorbances corrected for pyrene content as described in this
step 19 for each of the specified wavelength intervals shall not exceed
the limits prescribed in paragraph (d)(1)(ii) of this section.
d. If the spectrum as a whole of the sample solution is in any
respect clearly incompatible with the presence of pyrene as the
[[Page 416]]
source of the peak at 334 m[mu], then the maximum absorbances in the
respective wavelength intervals without correction for any assumed
pyrene content shall not exceed the limits prescribed in paragraph
(d)(1)(ii) of this section.
[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982;
49 FR 10112, Mar. 19, 1984; 54 FR 24898, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3650]
[Page 416]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3650 Odorless light petroleum hydrocarbons.
Odorless light petroleum hydrocarbons may be safely used, as a
component of nonfood articles intended for use in contact with food, in
accordance with the following prescribed conditions:
(a) The additive is a mixture of liquid hydrocarbons derived from
petroleum or synthesized from petroleum gases. The additive is chiefly
paraffinic, isoparaffinic, or naphthenic in nature.
(b) The additive meets the following specifications:
(1) Odor is faint and not kerosenic.
(2) Initial boiling point is 300 deg.F minimum.
(3) Final boiling point is 650 deg.F maximum.
(4) Ultraviolet absorbance limits determined by method specified in
Sec. 178.3620(b)(1)(ii), as follows:
------------------------------------------------------------------------
Maximum
absorbance
per
Wavelength (M[mu]) centimeter
optical
pathlength
------------------------------------------------------------------------
280 to 289.................................................. 4.0
290 to 299.................................................. 3.3
300 to 329.................................................. 2.3
330 to 360.................................................. .8
------------------------------------------------------------------------
(c) The additive is used as follows:
------------------------------------------------------------------------
Use Limitations
------------------------------------------------------------------------
As a plasticizer and absorber oil in In an amount not to exceed that
the manufacture of polyolefin articles required to produce intended
authorized for food contact use. effect, consistent with good
manufacturing practice.
As a lubricant of fibers of textiles At a use level not to exceed
authorized for food contact use. 0.15 percent by weight of
finished fibers.
As a component of adhesives............ Complying with Sec. 175.105 of
this chapter.
As a defoamer in the manufacture of Complying with Sec. 176.210 of
paper and paperboard. this chapter.
As a defoamer in coatings.............. Complying with Sec. 176.200 of
this chapter.
------------------------------------------------------------------------
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3690]
[Page 416-417]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3690 Pentaerythritol adipate-stearate.
Pentaerythritol adipate-stearate identified in paragraph (a) of this
section may be safely used as a lubricant in the fabrication of rigid
and semi-rigid polyvinyl chloride and/or vinyl chloride-propylene
copolymers complying with Sec. 177.1980 of this chapter used as articles
or components of articles that contact food, excluding food with alcohol
content greater than 8 percent under conditions of use of E, F, and G
described in table 2 in Sec. 175.300(d) of this chapter, subject to the
provisions of this section.
(a) Identity. For the purpose of this section, pentaerythritol
adipate-stearate is an ester of pentaerythritol with adipic acid and
stearic acid and its associated fatty acids (chiefly palmitic), with
adipic acid comprising 14 percent and stearic acid and its associated
acids (chiefly palmitic) comprising 71 percent of the organic moieties.
(b) Specifications. Pentaerythritol adipate-stearate has the
following specifications:
(1) Melting point (dropping) of 55-58 deg.C as determined by ASTM
method D566-76 (Reapproved 1982), "Standard Test Method for Dropping
Point of Lubricating Grease," which is incorporated by reference.
Copies may be obtained from the American Society for Testing Materials,
1916 Race St., Philadelphia, PA 19103, or may be examined at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(2) Acid value not to exceed 15 as determined by ASTM method D1386-
78, "Standard Test Method for Saponification Number (Empirical) of
Synthetic and Natural Waxes" (Revised 1978), which is incorporated by
reference. Copies are available from American Society for Testing and
Materials
[[Page 417]]
(ASTM), 1916 Race Street, Philadelphia, PA 19103, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(3) Saponification number of 270-280 as determined by ASTM method
D1387-78, "Standard Test Method for Acid Number (Empirical) of
Synthetic and Natural Waxes" (Revised 1978), which is incorporated by
reference. Copies are available from American Society for Testing and
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available
for inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(4) Iodine number not to exceed 2 as determined by Iodine Absorption
Number, Hanus Method, of the "Official Methods of Analysis of the
Association of Official Analytical Chemists," sections 28.018-28.019,
13th Ed. (1980), which is incorporated by reference. Copies may be
obtained from the Association of Official Analytical Chemists
International, 481 North Frederick Ave., suite 500, Gaithersburg, MD
20877-2504, or may be examined at the Office of the Federal Register,
800 North Capitol Street, NW., suite 700, Washington, DC 20408.
(c) The total amount of ester (calculated as free pentaerythritol)
shall not exceed 0.4 percent by weight of the polyvinyl chloride and/or
the vinyl chloride-propylene copolymers complying with Sec. 177.1980.
[45 FR 1018, Jan. 4, 1980, as amended at 47 FR 11848, Mar. 19, 1982; 49
FR 10112, Mar. 19, 1984; 54 FR 24898, June 12, 1989; 57 FR 18082, Apr.
29, 1992]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3700]
[Page 417]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3700 Petrolatum.
Petrolatum may be safety used as a component of nonfood articles in
contact with food, in accordance with the following conditions:
(a) Petrolatum complies with the specifications set forth in the
United States Pharmacopeia XX (1980) for white petrolatum or in the
National Formulary XV (1980) for yellow petrolatum.
(b) Petrolatum meets the following ultraviolet absorbance limits
when subjected to the analytical procedure described in Sec. 172.886(b)
of this chapter:
Ultraviolet absorbance per centimeter pathlength:
------------------------------------------------------------------------
Millimicrons Maximum
------------------------------------------------------------------------
280 to 289.................................................. 0.25
290 to 299.................................................. .20
300 to 359.................................................. .14
360 to 400.................................................. .04
------------------------------------------------------------------------
(c) It is used or intended for use as a protective coating of the
surfaces of metal or wood tanks used in fermentation process, in an
amount not in excess of that required to produce its intended effect.
(d) Petrolatum as defined by this section may be used for the
functions described and within the limitations prescribed by specific
regulations in parts 175, 176, 177, and 178 of this chapter which
prescribe uses of petrolatum. For the purpose of cross-reference, such
specific regulations include: Secs. 175.105, 175.125, 175.300, 176.170,
176.200, 176.210, 177.2600, 177.2800, and 178.3570 of this chapter.
(e) Petrolatum may contain any antioxidant permitted in food by
regulations issued pursuant to section 409 of the act, in an amount not
greater than that required to produce its intended effect.
[42 FR 14609, Mar. 15, 1977, as amended at 49 FR 10113, Mar. 19, 1984;
55 FR 12172, Apr. 2, 1990]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3710]
[Page 417-418]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3710 Petroleum wax.
Petroleum wax may be safely used as a component of nonfood articles
in contact with food, in accordance with the following conditions:
(a) Petroleum wax is a mixture of solid hydrocarbons, paraffinic in
nature, derived from petroleum, and refined to meet the specifications
prescribed in this section.
(b) The petroleum wax meets the following ultraviolet absorbance
limits when subjected to the analytical procedure described in
Sec. 172.886(b) of this chapter.
Ultraviolet absorbance per centimeter pathlength:
------------------------------------------------------------------------
Millimicrons Maximum
------------------------------------------------------------------------
280 to 289.................................................. 0.15
290 to 299.................................................. .12
300 to 359.................................................. .08
360 to 400.................................................. .02
------------------------------------------------------------------------
[[Page 418]]
(c) Petroleum wax may contain any antioxidant permitted in food by
regulations issued in accordance with section 409 of the act, in an
amount not greater than that required to produce its intended effect.
(d) Petroleum wax may contain a total of not more than 1 weight
percent of residues of the following polymers when such residues result
from use of the polymers as processing aids (filter aids) in the
production of the petroleum wax: Homopolymers and/or copolymers derived
from one or more of the mixed n-alkyl (C12, C14,
C16, and C18) methacrylate esters where the
C12 and C14 alkyl groups are derived from coconut
oil and the C16 and C18 groups are derived from
tallow.
(e) Petroleum wax may contain 2-hydroxy-4-n-octoxybenzophenone as a
stabilizer at a level not to exceed 0.01 weight percent of the petroleum
wax.
(f) Petroleum wax may contain poly(alkylacrylate) (CAS Reg. No.
27029-57-8), as described in Sec. 172.886(c)(2) of this chapter, as a
processing aid in the manufacture of petroleum wax.
[42 FR 14609, Mar. 15, 1977, as amended at 51 FR 19545, May 30, 1986]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3720]
[Page 418]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3720 Petroleum wax, synthetic.
Synthetic petroleum wax may be safely used in applications and under
the same conditions where naturally derived petroleum wax is permitted
in subchapter B of this chapter as a component of articles intended to
contact food, provided that the synthetic petroleum wax meets the
definition and specifications prescribed in Sec. 172.888 of this
chapter.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3725]
[Page 418]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3725 Pigment dispersants.
Subject to the provisions of this regulation, the substances listed
in this section may be safely used as pigment dispersants in food-
contact materials.
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Dimethylolpropionic acid (CAS Reg. No. For use only at levels not to
4767-03-7). 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 Sec. 176.170(c) of
this chapter.
Phosphorylated tall oil fatty acids For use only at levels not to
(CAS Reg. No. 68604-99-9), prepared by exceed 1.0 percent by weight
the reaction of dimethyl hydrogen of the pigment. The pigmented
phosphite with tall oil fatty acids. polymeric films may contact
all food under conditions of
use D, E, F, and G described
in table 2 of Sec. 176.170(c)
of this chapter.
Propanoic acid, 3-hydroxy-2- For use only at levels not to
(hydroxymethyl)-2-methyl-, compd. with exceed 0.45 percent by weight
1,1',1[dprime]-nitrilotris [2- of the pigment. The pigmented
propanol] (1:1) (CAS Reg. No. 221281- articles may contact all food
21-6). under conditions of use A
through H as described in
Table 2 of Sec. 176.170(c) of
this chapter.
Siloxanes and silicones; cetylmethyl, For use only at levels not to
dimethyl, methyl 11-methoxy-11- exceed 0.5 percent by weight
oxoundecyl (CAS Reg. No. 155419-59-3). of the pigment. The pigmented
polymers may contact all foods
under conditions of use C, D,
E, F, and G described in Table
2 of Sec. 176.170(c) of this
chapter.
Trimethylolethane (CAS Reg. No. 77-85- For use only at levels not to
0). 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 Sec. 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]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3730]
[Page 418]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3730 Piperonyl butoxide and pyrethrins as components of bags.
Piperonyl butoxide in combination with pyrethrins may be safely used
for insect control on bags that are intended for use in contact with
dried feed in compliance with Secs. 561.310 and 561.340 of this chapter,
or that are intended for use in contact with dried food in compliance
with Secs. 193.60 and 193.390 of this chapter.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3740]
[Page 418-421]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3740 Plasticizers in polymeric substances.
Subject to the provisions of this regulation, the substances listed
in paragraph (b) of this section may be safely used as plasticizers in
polymeric substances used in the manufacture of articles or components
of articles intended for use in producing, manufacturing, packing,
processing, preparing,
[[Page 419]]
treating, packaging, transporting, or holding food.
(a) The quantity used shall not exceed the amount reasonably
required to accomplish the intended technical effect.
(b) List of substances:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Butylbenzyl phthalate........... For use only:
1. As provided in Secs. 175.105 and
176.180 of this chapter.
2. In polymeric substances used in
food-contact articles complying with
Sec. 175.300, Sec. 175.320, or Sec.
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 percent by weight of dibenzyl
phthalate; and Provided further, That
the finished food-contact article,
when extracted with the solvent or
solvents characterizing the type of
food and under the conditions of time
and temperature characterizing the
conditions of its intended use as
determined from tables 1 and 2 of
Sec. 175.300(d) of this chapter,
shall yield net chloroform-soluble
extractives not to exceed 0.5 mg. per
square inch, as determined by the
methods prescribed in Sec.
175.300(e) of this chapter.
1,3-Butylene glycoladipic acid For use at levels not exceeding 33
polyester (1,700-2,200 percent by weight of polyvinyl
molecular weight) terminated chloride homopolymers used in contact
with a 16 percent by weight with food (except foods that contain
mixture of myristic, palmitic, more than 8 percent of alcohol) at
and stearic acids. temperatures not to exceed room
temperature. The average thickness of
such homopolymers in the form in
which they contact food shall not
exceed 0.004 inch.
Di(C7, C9-alkyl) adipate, in For use only under the conditions
which the C7, C9-alkyl groups listed below, and excluding use as a
are derived from linear alpha component of resinous and polymeric
olefins by the oxo process. coatings described in Sec. 175.300
of 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
average 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 Sec.
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 contact food shall not exceed
0.005 inch.
3. At levels not exceeding 35 pct by
weight of permitted vinyl chloride
homo- and/or copolymers used in
contact with nonfatty foods. The
average thickness of such polymer in
the form in which they contact food
shall not exceed 0.002 inch.
4. At levels not exceeding 35 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 Sec.
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
contact food shall not exceed 0.002
inch.
Di-n-alkyl adipate made from C6 For use only:
C8-C10 (predominately C8 and 1. At levels not exceeding 24 pct by
C10) or C8-C10 synthetic fatty weight of permitted vinyl chloride
alcohols complying with Sec. homo- and/or copolymers used in
172.864 of this chapter. contact with nonfatty foods. The
average thickness of such polymers in
the form in which they contact food
shall not exceed 0.005 inch.
2. At levels not exceeding 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 Sec.
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 contact food shall not exceed
0.005 inch.
3. At levels not exceeding 35 pct by
weight of permitted vinyl chloride
homo- and/or copolymers used in
contact with nonfatty foods. The
average thickness of such polymers in
the form in which they contact food
shall not exceed 0.002 inch.
4. At levels not exceeding 35 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 Sec.
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 which they
contact food shall not exceed 0.002
inch.
[[Page 420]]
Dicyclohexyl phthalate.......... For use only:
1. As provided in Secs. 175.105,
176.170, 176.180, and 177.1200 of
this chapter.
2. Alone or in combination with other
phthalates, in plastic film or sheet
prepared from polyvinyl acetate,
polyvinyl chloride, and/or vinyl
chloride copolymers complying with
Sec. 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........ ......................................
Diisononyl adipate.............. For use only:
1. At levels not exceeding 24 pct by
weight of permitted vinyl chloride
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.
2. At levels not exceeding 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 Sec.
176.170(c) of this chapter with
fatty, nonalcoholic 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.
3. At levels not exceeding 35 pct by
weight of permitted vinyl chloride
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 0.002
inch.
4. At levels not exceeding 35 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 Sec.
176.170(c) of this chapter with
fatty, nonalcoholic 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 contact food
shall not exceed 0.002 inch.
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 Sec. 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:
1. At levels not exceeding 24 pct by
weight of permitted vinyl chloride
homo- and/or copolymers used in
contact with nonfatty, nonalcoholic
food. The average thickness of such
polymers in the form in which they
contact food shall not exceed 0.003
inch.
2. At levels not exceeding 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 Sec.
176.170(c) of this chapter, with
fatty, nonalcoholic 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 which they contact food shall
not exceed 0.003 inch.
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 substance
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 Sec. 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 contact food shall
not exceed 0.003 inch.
Dihexyl phthalate............... For use only:
1. As provided in Sec. 175.105 of
this chapter.
2. In articles that contact food only
of the types identified in Sec.
176.170(c) of this chapter, table 1,
under Categories I, II, IV-B, VI-B,
and VIII.
Diphenyl phthalate.............. For use only:
1. As provided in Sec. 175.105 of
this chapter.
2. Alone or in combination with other
phthalates, in plastic film or sheet
prepared from polyvinyl acetate,
polyvinyl chloride, and/or vinyl
chloride copolymers complying with
Sec. 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 Iodine number, maximum 5; oxirane
linseed oil fatty acids. oxygen, minimum 7.8 pct.
Epoxidized linseed oil.......... Iodine number, maximum 5; oxirane
oxygen, minimum 9-pct.
[[Page 421]]
Mineral oil, white..............
Polybutene, hydrogenated For use only:
(minimum viscosity at 99 1. In polymeric substances used in
deg.F, 39 Saybolt Universal contact with non-fatty food.
seconds, as determined by ASTM 2. In polyethylene complying with Sec.
methods D445-82 ("Standard 177.1520 of this chapter and used in
Test Method for Kinematic contact with fatty food, provided
Viscosity of Transparent and that the hydrogenated polybutene is
Opaque Liquids (and the added in an amount not to exceed 0.5
Calculation of Dynamic pct by weight of the polyethylene,
Viscosity)") and D2161-82 and further provided that such
("Standard Method for plasticized polyethylene shall not be
Conversion of Kinematic used as a component of articles
Viscosity to Saybolt Universal intended for packing or holding food
Viscosity or to Saybolt Furol during cooking.
Viscosity"), and bromine 3. In polystyrene complying with Sec.
number of 3 or less, as 177.1640 of this chapter and used in
determined by ASTM method D1492- contact with fatty food, provided
78 ("Standard Test Method for that the hydrogenated polybutene is
Bromine Index of Aromatic added in an amount not to exceed 5
Hydrocarbons by Coulometric pct by weight of the polystyrene, and
Titration"), which are further provided that such
incorporated by reference. plasticized polystyrene shall not be
Copies may be obtained from the used as a component of articles
American Society for Testing intended for packing or holding food
Materials, 1916 Race St., during cooking.
Philadelphia, PA 19103, or may
be examined at the Office of
the Federal Register, 800 North
Capitol Street, NW., suite 700,
Washington, DC 20408.
Polyisobutylene (mol weight 300- For use in polyethylene complying with
5,000). Sec. 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 polyethylene shall not be
used as a component of articles
intended for packing or holding food
during cooking.
Polyisobutylene complying with
Sec. 177.1420 of this chapter.
Polypropylene glycol (CAS For use only in polystyrene plastics,
registry No. 25322-69-4) identified in Sec. 177.1640(a)(1),
(minimum mean molecular weight in an amount not to exceed 6 pct by
1,200). weight of the finished food-contact
article.
Propylene glycol azelate For use only at levels not exceeding
(average mol. weight 3,000). 41 pct by weight of permitted
polyvinyl chloride coatings. Such
coatings shall be used only as bulk
food contact surfaces of articles
intended for repeated use, complying
with Sec. 177.2600 of this chapter.
Triethylene glycol.............. Diethylene glycol content not to
exceed 0.1 pct.
2,2,4-Trimethyl-1,3-pentanediol For use only in cellulosic plastics in
diisobutyrate. an amount not to exceed 15 pct by
weight of the finished food-contact
article, provided that the finished
plastic article contacts food only of
the types identified in Sec.
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 polymeric substance or
article subject to any regulation in parts 174, 175, 176, 177, 178 and
179 of this chapter must comply with any specifications and limitations
prescribed by such regulation for the finished form of the substance or
article.
[42 FR 14609, Mar. 15, 1977, as amended at 42 FR 44223, Sept. 2, 1977;
45 FR 56052, Aug. 22, 1980; 48 FR 5748, Feb. 15, 1984; 49 FR 10113, Mar.
19, 1984; 51 FR 47011, Dec. 30, 1986]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3750]
[Page 421]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3750 Polyethylene glycol (mean molecular weight 200-9,500).
Polyethylene glycol identified in this section may be safely used as
a component of articles intended for use in contact with food, in
accordance with the following prescribed conditions:
(a) The additive is an addition polymer of ethylene oxide and water
with a mean molecular weight of 200 to 9,500.
(b) It contains no more than 0.2 percent total by weight of ethylene
and diethylene glycols if its mean molecular weight is 350 or higher and
no more than 0.5 percent total by weight of ethylene and diethylene
glycols if its mean molecular weight is below 350, when tested by the
analytical methods prescribed in Sec. 172.820(b) of this chapter.
(c) The provisions of paragraph (b) of this section are not
applicable to polyethylene glycols used in food-packaging adhesives
complying with Sec. 175.105 of this chapter.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3760]
[Page 421]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3760 Polyethylene glycol (400) monolaurate.
Polyethylene glycol (400) monolaurate containing not more than 0.1
percent by weight of ethylene and/or diethylene glycol may be used at a
level not to exceed 0.3 percent by weight of twine as a finish on twine
to be used for tying meat provided the twine fibers are produced from
nylon resins complying with Sec. 177.1500 of this chapter.
[[Page 422]]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3770]
[Page 422-427]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3770 Polyhydric alcohol esters of oxidatively refined (Gersthofen process) montan wax acids.
Polyhydric alcohol esters of oxidatively refined (Gersthofen
process) montan wax acids identified in this section may be safely used
as components of articles intended for use in contact with food in
accordance with the following prescribed conditions:
(a) The polyhydric alcohol esters identified in this paragraph may
be used as lubricants in the fabrication of vinyl chloride plastic food-
contact articles prepared from polyvinyl chloride and/or from vinyl
chloride copolymers complying with Sec. 177.1980 of this chapter. Such
esters meet the following specifications and are produced by partial
esterification of oxidatively refined (Gersthofen process) montan wax
acids by either ethylene glycol or 1,3-butanediol with or without
neutralization of unreacted carboxylic groups with calcium hydroxide:
(1) Dropping point 76 deg.-105 deg.C, as determined by ASTM method
D566-76 (Reapproved 1982), "Standard Test Method for Dropping Point of
Lubricating Grease," which is incorporated by reference. Copies may be
obtained from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(2) Acid value 10-20, as determined by ASTM method D1386-78
("Standard Test Method for Acid Number (Empirical) of Synthetic and
Natural Waxes" (Revised 1978), which is incorporated by reference;
copies are available from American Society for Testing and Materials
(ASTM), 1916 Race Street, Philadelphia, PA 19103, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408) using as solvent xylene-
ethyl alcohol in a 2:1 ratio instead of toluene-ethyl alcohol in a 2:1
ratio.
(3) Saponification value 100-160, as determined by ASTM method
D1387-78 ("Standard Test Method for Saponification Number (Empirical)
of Synthetic and Natural Waxes" (Revised 1978), which is incorporated
by reference; copies are available from American Society for Testing and
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available
for inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408) using xylene-ethyl alcohol
in a 2:1 ratio instead of ethyl alcohol in preparation of potassium
hydroxide solution.
(4) Ultraviolet absorbance limits as follows, as determined by the
analytical method described in this subparagraph:
Ultraviolet absorbance per centimeter pathlength.
------------------------------------------------------------------------
Millimicrons Maximum
------------------------------------------------------------------------
280 to 289.................................................. 0.07
290 to 299.................................................. .06
300 to 359.................................................. .04
360 to 400.................................................. .01
------------------------------------------------------------------------
Analytical Method
general instructions
Because of the sensitivity of the test, the possibility of errors
arising from contamination is great. It is of the greatest importance
that all glassware be scrupulously cleaned to remove all organic matter
such as oil, grease, detergent residues, etc. Examine all glassware,
including stoppers and stopcocks, under ultraviolet light to detect any
residual fluorescent contamination. As a precautionary measure it is
recommended practice to rinse all glassware with purified isooctane
immediately before use. No grease is to be used on stopcocks or joints.
Great care to avoid contamination of wax samples in handling and to
assure absence of any extraneous material arising from inadequate
packaging is essential. Because some of the polynuclear hydrocarbons
sought in this test are very susceptible to photo-oxidation, the entire
procedure is to be carried out under subdued light.
apparatus
Separatory funnels. 250-milliliter, 500-milliliter, 1,000-
milliliter, and preferably 2,000-milliliter capacity, equipped with
tetrafluoroethylene polymer stopcocks.
Reservoir. 1,000-milliliter capacity, equipped with a 24/40 standard
taper male fitting at the bottom and a suitable balljoint at the top.
Chromatographic tube. 1,200 millimeters in length, inside diameter
to be 16.5 millimeters 0.5 millimeter, equipped with a
coarse, fritted-glass disc, a tetrafluoroethylene polymer stopcock, and
a female 24/40 standard tapered fitting at the opposite end. (Overall
length of
[[Page 423]]
the column with the female joint is 1,255 millimeters.) The female
fitting should be equipped with glass hooks.
Disc. Tetrafluoroethylene polymer 2-inch diameter disc approximately
\3/16\-inch thick with a hole bored in the center to closely fit the
stem of the chromatographic tube.
Heating jackets. Conical, for 500-milliliter and 1,000-milliliter
separatory funnels. (Used with variable transformer heat control.)
Suction flask. 250-milliliter or 500-milliliter filter flask.
Condenser. \24/40\ joints, fitted with a drying tube, length
optional.
Evaporation flasks (optional). A 250-milliliter or 500-milliliter
capacity and a 1-liter capacity all-glass flask equipped with standard
taper stopper having inlet and outlet tubes to permit passage of
nitrogen across the surface of contained liquid to be evaporated.
Vacuum distillation assembly. All glass (for purification of
dimethyl sulfoxide) 2-liter distillation flask with heating mantle;
Vigreaux vacuum-jacketed condenser (or equivalent) about 45 centimeters
in length and distilling head with separable cold finger condenser. Use
of tetrafluoroethylene polymer sleeves on the glass joints will prevent
freezing. Do not use grease on stopcocks or joints.
Oil bath. Capable of heating to 90 deg.C.
Spectrophotometric cells. Fused quartz cells, optical pathlength in
the range 1.000 centimeter 0.005 centimeter. With distilled
water in the cells, determine any absorbance differences.
Spectrophotometer. Spectral range 250 millimicrons-400 millimicrons
with spectral slit width of 0.2 millimicron or less; under instrument
operating conditions for these absorbance measurements. The
spectrophotometer shall also meet the following performance
requirements:
Absorbance repeatability, 0.01 at 0.4 absorbance.
Absorbance accuracy, \1\ 0.05 at 0.4 absorbance.
---------------------------------------------------------------------------
\1\ As determined by procedure using potassium chromate for
reference standard and described in National Bureau of Standards
Circular 484, Spectrometry, U.S. Department of Commerce (1949). The
accuracy is to be determined by comparison with the standard values at
290, 345, and 400 millimicrons. Circular 484 is incorporated by
reference. Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
---------------------------------------------------------------------------
Wavelength repeatability, 0.2 millimicron.
Wavelength accuracy, 1.0 millimicron.
Recording time, 50 seconds.
Time constant, 0.6 second.
Sensitivity, 30.
Ordinate scale, 90-100 percent transmission through scale.
Abscissa scale, 8X.
Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in
cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.
reagents and materials
Organic solvents. All solvents used throughout the procedure shall
meet the specifications and tests described in this specification. The
isooctane and benzene designated in the list following this paragraph
shall pass the following test:
To be specified quantity of solvent in a 250-milliliter Erlenmeyer
flask, add 1 milliliter of purified n-hexadecane and evaporate on the
steam bath under a stream of nitrogen (a loose aluminum foil jacket
around the flask will speed evaporation). Discontinue evaporation when
not over 1 milliliter of residue remains. (To the residue from benzene
add a 10-milliliter portion of purified isooctane, reevaporate, and
repeat once to insure complete removal of benzene.)
Alternatively, the evaporation time can be reduced by using the
optional evaporation flask. In this case the solvent and n-hexadecane
are placed in the flask on the steam bath, the tube assembly is
inserted, and a stream of nitrogen is fed through the inlet tube while
the outlet tube is connected to a solvent trap and vacuum line in such a
way as to prevent any flow-back of condensate into the flask.
Dissolve the 1 milliliter of hexadecane residue in isooctane and
make up to 25 milliliters volume. Determine the absorbance in the 1-
centimeter pathlength cells compared to isooctane as reference. The
absorbance of the solution of the solvent residue (except for methyl
alcohol) shall not exceed 0.01 per centimeter pathlength between 280
m[mu] and 400 m[mu].
Isooctane (2,2,4-trimethylpentane). Use 180 milliliters for the test
described in the preceding paragraph. Purify, if necessary, by passage
through a column of activated silica gel (Grade 12, Davison Chemical
Co., Baltimore, Md., or equivalent) about 90 centimeters in length and 5
centimeters to 8 centimeters in diameter.
Benzene, A.C.S. reagent grade. Use 150 milliliters for the test.
Purify, if necessary, by distillation or otherwise.
n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 25 milliliters with isooctane and determine the absorbance
in a 1-centimeter cell compared to isooctane as reference point between
280 m[mu]-400 m[mu]. The absorbance per centimeter pathlength
[[Page 424]]
shall not exceed 0.00 in this range. If necessary, purify by filtering
through a column containing 100 grams of aluminum oxide (use same grade
as described below) in the lower half and 100 grams of activated silica
gel in the upper half keeping the column at 150 deg.C., for a period of
15 hours or overnight. The first 100 milliliters of eluate are used.
Purification can also be accomplished by distillation.
Dimethyl sulfoxide. Pure grade, clear, water-white, m.p. 18 deg.
minimum. Dilute 120 milliliters of dimethyl sulfoxide with 240
milliliters of distilled water in a 500-milliliter separatory funnel,
mix and allow to cool for 5-10 minutes. Add 40 milliliters of isooctane
to the solution and extract by shaking the funnel vigorously for 2
minutes. Draw off the lower aqueous layer into a second 500-milliliter
separatory funnel and repeat the extraction with 40 milliliters of
isooctane. Draw off and discard the aqueous layer. Wash each of the 40-
milliliter extractives three times with 50-milliliter portions of
distilled water. Shaking time for each wash is 1 minute. Discard the
aqueous layers. Filter the first extractive through anhydrous sodium
sulfate prewashed with isooctane (see Sodium sulfate under "Reagents
and materials" for preparation of filter), into a 250-milliliter
Erlenmeyer flask, or optionally into the evaporating flask. Wash the
first separatory funnel with the second 40-milliliter isooctane
extractive, and pass through the sodium sulfate into the flask. Then
wash the second and first separatory funnels successively with a 10-
milliliter portion of isooctane, and pass the solvent through the sodium
sulfate into the flask. Add 1 milliliter of n-hexadecane and evaporate
the isooctane on the steam bath under nitrogen. Discontinue evaporation
when not over 1 milliliter of residue remains. To the residue, add a 10-
milliliter portion of isooctane and reevaporate to 1 milliliter of
hexadecane. Again, add 10 milliliters of isooctane to the residue and
evaporate to 1 milliliter of hexadecane to insure complete removal of
all volatile materials. Dissolve the 1 milliliter of hexadecane in
isooctane and make to 25-milliliter volume. Determine the absorbance in
1-centimeter pathlength cells compared to isooctane as reference. The
absorbance of the solution should not exceed 0.02 per centimeter
pathlength in the 280 m[mu]-400 m[mu] range. (Note: Difficulty in
meeting this absorbance specification may be due to organic impurities
in the distilled water. Repetition of the test omitting the dimethyl
sulfoxide will disclose their presence. If necessary to meet the
specification, purify the water by redistillation, passage through an
ion-exchange resin, or otherwise.)
Purify, if necessary, by the following procedure: To 1,500
milliliters of dimethyl sulfoxide in a 2-liter glass-stoppered flask,
add 6.0 milliliters of phosphoric acid and 50 grams of Norit A
(decolorizing carbon, alkaline) or equivalent. Stopper the flask, and
with the use of a magnetic stirrer (tetrafluoroethylene polymer coated
bar) stir the solvent for 15 minutes. Filter the dimethyl sulfoxide
through four thicknesses of fluted paper (18.5 centimeters, Schleicher &
Schuell, No. 597, or equivalent). If the initial filtrate contains
carbon fines, refilter through the same filter until a clear filtrate is
obtained. Protect the sulfoxide from air and moisture during this
operation by covering the solvent in the funnel and collection flask
with a layer of isooctane. Transfer the filtrate to a 2-liter separatory
funnel and draw off the dimethyl sulfoxide into the 2-liter distillation
flask of the vacuum distillation assembly and distill at approximately
3-millimeter Hg pressure or less. Discard the first 200-milliliter
fraction of the distillate and replace the distillate collection flask
with a clean one. Continue the distillation until approximately 1 liter
of the sulfoxide has been collected.
At completion of the distillation, the reagent should be stored in
glass-stoppered bottles since it is very hygroscopic and will react with
some metal containers in the presence of air.
Phosphoric acid. 85 percent A.C.S. reagent grade.
Aluminum oxide (80-200 mesh Woelm neutral activity grade 1
[Brockmann], Alupharm Chemicals, New Orleans, La., or equivalent).
Pipette 1 milliliter of distilled water into a dry 250-milliliter
Erlenmeyer flask equipped with a ground-glass stopper. Stopper the flask
and rotate it in such a manner as to completely wet out the inside
surfaces. When this has been done add 180 grams of the aluminum oxide
and shake until no lumps or wet spots remain. Allow to stand at room
temperature for a period of 2 hours. At the end of this time the water
should be evenly distributed throughout the aluminum oxide powder, and
it should have the same free flowing properties as the original material
(flow velocity with water 0.2 milliliter per minute). At this point the
aluminum oxide has an activity of 1 as expressed in Brockmann degrees,
and the amount of added water is 0.5 percent by volume. This product is
used in toto and as is, without further screening.
Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in
granular form. For each bottle of sodium sulfate reagent used, establish
as follows the necessary sodium sulfate prewash to provide such filters
required in the method: Place approximately 35 grams of anhydrous sodium
sulfate in a 30-milliliter coarse, fritted-glass funnel or in a 65-
millimeter filter funnel with glass wool plug; wash with successive 15-
milliliter portions of the indicated solvent until a 15-milliliter
portion of the wash shows 0.00 absorbance per centimeter pathlength
between 280 m[mu] and 400 m[mu] when tested as prescribed under
[[Page 425]]
"Organic solvents." Usually three portions of wash solvent are
sufficient.
procedure
Before proceeding with analysis of a sample, determine the
absorbance in a 1-centimeter path cell between 250 m[mu] and 400 m[mu]
for the reagent blank by carrying out the procedure, without a wax
sample, at room temperature, recording the spectrum after the complete
procedure as prescribed. The absorbance per centimeter pathlength
following the complete procedure should not exceed 0.04 in the
wavelength range from 280 m[mu] to 299 m[mu], inclusive, nor 0.02 in the
wavelength range from 300 m[mu] to 400 m[mu]. If in either spectrum the
characteristic benzene peaks in the 250 m[mu]-260 m[mu] region are
present, remove the benzene by the procedure under "Organic solvents"
and record absorbance again. Place 300 milliliters of dimethyl sulfoxide
in a 1-liter separatory funnel and add 75 milliliters of phosphoric
acid. Mix the contents of the funnel and allow to stand for 10 minutes.
(The reaction between the sulfoxide and the acid is exothermic. Release
pressure after mixing, then keep funnel stoppered.) Add 150 milliliters
of isooctane and shake to preequilibrate the solvents. Draw off the
individual layers and store in glass-stoppered flasks.
In a 1-liter separatory funnel place a representative 25-gram sample
of wax, add 50 milliliters of isooctane, heat gently, stir until the wax
is in solution; add 100 milliliters of preequilibrated sulfoxide-
phosphoric acid mixture and shake, making sure it remains in solution.
If the wax comes out of solution during these operations, let the
stoppered funnel remain in the jacket until the wax redissolves. (Remove
stopper from the funnel at intervals to release pressure.) When the wax
is in solution, remove the funnel from the jacket and shake it
vigorously for 2 minutes. Set up three 250-milliliter separatory funnels
with each containing 30 milliliters of preequilibrated isooctane. After
separation of the liquid phases, allow to cool until the main portion of
the wax-isooctane solution begins to show a precipitate. Gently swirl
the funnel when precipitation first occurs on the inside surface of the
funnel to accelerate this process. Carefully draw off the lower layer,
filter it slowly through a thin layer of glass wool fitted loosely in a
filter funnel into the first 250-milliliter separatory funnel, and wash
in tandem with the 30-milliliter portions of isooctane contained in the
250-milliliter separatory funnels. Shaking time for each wash is 1
minute. Repeat the extraction operation with two additional portions of
the sulfoxide-acid mixture, replacing the funnel in the jacket after
each extraction to keep the wax in solution and washing each extractive
in tandem through the same three portions of isooctane.
Collect the successive extractives (300 milliliters total) in a
separatory funnel (preferably 2-liter), containing 480 milliliters of
distilled water, mix, and allow to cool for a few minutes after the last
extractive has been added. Add 80 milliliters of isooctane to the
solution and extract by shaking the funnel vigorously for 2 minutes.
Draw off the lower aqueous layer into a second separatory funnel
(preferably 2-liter) and repeat the extraction with 80 milliliters of
isooctane. Draw off and discard the aqueous layer. Wash each of the 80-
milliliter extractives three times with 100-milliliter portions of
distilled water. Shaking time for each wash is 1 minute. Discard the
aqueous layers. Filter the first extractive through anhydrous sodium
sulfate prewashed with isooctane (see Sodium sulfate under "Reagents
and Materials" for preparation of filter) into a 250-milliliter
Erlenmeyer flask (or optionally into the evaporation flask). Wash the
first separatory funnel with the second 80-milliliter isooctane
extractive and pass through the sodium sulfate. Then wash the second and
first separatory funnels successively with a 20-milliliter portion of
isooctane and pass the solvent through the sodium sulfate into the
flask. Add 1 milliliter of n-hexadecane and evaporate the isooctane
using an aspirator vacuum under nitrogen and in an oil bath temperature
of approximately 90 deg.C. Discontinue evaporation when not over 1
milliliter of residue remains. To the residue, add a 10-milliliter
portion of isooctane, reevaporate to 1 milliliter of hexadecane, and
repeat this operation once.
Reserve the residue for column chromatography on the aluminum oxide.
Fit the tetrafluoroethylene polymer disc on the upper part of the stem
of the chromatographic tube, then place the tube with the disc on the
suction flask and apply the vacuum (approximately 135 millimeters Hg
pressure). Weigh out 180 grams of the aluminum oxide and pour the
adsorbent mixture into the chromatographic tube in approximately 30-
centimeter layers. After the addition of each layer, level off the top
of the adsorbent with a flat glass rod or metal plunger by pressing down
firmly until the adsorbent is well packed. Loosen the topmost few
millimeters of each adsorbent layer with the end of a metal rod before
the addition of the next layer. Continue packing in this manner until
all the 180 grams of the adsorbent is added to the tube. Level off the
top of the adsorbent by pressing down firmly with a flat glass rod or
metal plunger to make the depth of the adsorbent bed approximately 80
centimeters in depth. Turn off the vacuum and remove the suction flask.
Dissolve the hexadecane residue in 10 milliliters of warm benzene and
decant the solution onto the column and allow the liquid level to recede
to barely above the adsorbent level. Rapidly complete the transfer
similarly with two 10-
[[Page 426]]
milliliter portions of benzene swirling the flask repeatedly each time
to assure adequate washing of the residue. Fix the 1,000-milliliter
reservoir onto the top of the chromatographic column. Just before the
final 10-milliliter wash reaches the top of the adsorbent, add 670
milliliters of benzene to the reservoir and continue the percolation at
the 2-3 milliliter per minute rate until a total of 670 milliliters of
benzene has been utilized. Collect the eluate in a clean 1-liter
Erlenmeyer flask (or optionally into a 1-liter evaporation flask). Allow
the column to drain until most of the solvent mixture is removed. Add 1
milliliter of n-hexadecane and completely remove the benzene by
evaporation under nitrogen, using the special procedure to eliminate
benzene as previously described under "Organic Solvents."
Quantitatively transfer the residue with isooctane to a 25-milliliter
volumetric flask and adjust to volume. Determine the absorbance of the
solution in the 1-centimeter pathlength cells compared to isooctane as
reference between 250 m[mu]-400 m[mu]. Correct for any absorbance
derived from the reagents as determined by carrying out the procedure
without a wax sample. If either spectrum shows the characteristic
benzene peaks in the 250 m[mu]-260 m[mu] region, evaporate the solution
to remove benzene by the procedure under "Organic Solvents." Dissolve
the residue, transfer quantitatively, and adjust to volume in isooctane
in a 25-milliliter volumetric flask. Record the absorbance again. If the
corrected absorbance does not exceed the limits prescribed in paragraph
(a) of this section, the wax meets the ultraviolet absorbance
specifications.
(b) The polyhydric alcohol esters identified in this paragraph may
be used as release agents in resinous and polymeric coatings for
polyolefin films complying with Sec. 175.320 of this chapter. Such
esters meet the following specifications and are produced by partial
esterification of oxidatively refined (Gersthofen process) montan wax
acids with equimolar proportions of ethylene glycol and 1,3-butanediol:
(1) Dropping point 77 deg.-82 deg.C, as determined by ASTM method
D566-76 (Reapproved 1982), "Standard Test Method for Dropping Point of
Lubricating Grease," which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(a)(1) of this section.
(2) Acid value 25-35, as determined by ASTM method D1386-78
("Standard Test Method for Acid Number (Empirical) of Synthetic and
Natural Waxes" (Revised 1978), which is incorporated by reference;
copies are available from American Society for Testing and Materials
(ASTM), 1916 Race Street, Philadelphia, PA 19103, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408) using as solvent xylene-
ethyl alcohol in a 2:1 ratio instead of toluene-ethyl alcohol in a 1:2
ratio.
(3) Saponification value 135-150, as determined by ASTM method
D1387-78 ("Standard Test Method for Saponification Number (Empirical)
of Synthetic and Natural Waxes" (Revised 1978), which is incorporated
by reference; copies are available from American Society for Testing and
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available
for inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408) using xylene-ethyl alcohol
in a 2:1 ratio instead of ethyl alcohol in preparation of potassium
hydroxide solution.
(4) Ultraviolet absorbance limits specified in paragraph (a)(4) of
this section, as determined by the analytical method described therein.
(c) The polyhydric alcohol esters of oxidatively refined (Gersthofen
process) montan wax acids, identified in paragraph (a) or (b) of this
section, may also be used as a component of an aqueous dispersion of
vinylidene chloride copolymers, subject to the conditions described in
paragraphs (c) (1) and (2) of this section.
(1) The aqueous dispersion of the additive contains not more that 18
percent polyhydric alcohol esters of oxidatively refined (Gersthofen
process) montan wax acids, not more than 2 percent poly(oxyethylene)
(minimum 20 moles of ethylene oxide) oleyl ether (CAS Reg. No. 9005-98-
2), and not more than 1 percent poly(oxyethylene) (minimum 3 moles
ethylene oxide) cetyl alcohols (CAS Reg. No. 9004-95-9).
(2) The aqueous dispersion described in paragraph (c)(1) of this
section is used as an additive to aqueous dispersions of vinylidene
chloride copolymers, regulated in Secs. 175.300, 175.320, 175.360,
176.170, 176,180, and 177.1630 of this chapter, at levels not to exceed
1.5 percent (solids basis) in the finished coating.
[[Page 427]]
(d) The polyhydric alcohol esters identified in this paragraph may
be used as lubricants in the fabrication of vinyl chloride plastic food
contact articles prepared from vinyl chloride polymers. Such esters meet
the following specifications and are produced by partial esterification
of oxidatively refined (Gersthofen process) montan wax acids with
glycerol followed by neutralization:
(1) Dropping point 79 to 85 deg.C, as determined by the American
Society for Testing and Materials (ASTM), Method D-566-76 (Reapproved
1982), "Standard Test Method for Dropping Point of Lubricating
Grease," which is incorporated by reference in accordance with 5 U.S.C.
552(a). The availability of this incorporation by reference is given in
paragraph (a)(1) of this section.
(2) Acid value 20-30, as determined by ASTM Method D-1386-78
"Standard Test Method for Acid Number (Empirical) of Synthetic and
Natural Waxes" (Revised 1978) (which is incorporated by reference in
accordance with 5 U.S.C. 552(a); the availability of this incorporation
by reference is given in paragraph (a)(2) of this section), using as a
solvent xylene-ethyl alcohol in a 2:1 ratio instead of toluene-ethyl
alcohol in a 2:1 ratio.
(3) Saponification value 130-160, as determined by ASTM Method D-
1387-78 "Standard Test Method for Saponification Number (Empirical) of
Synthetic and Natural Waxes" (Revised 1978), (which is incorporated by
reference in accordance with 5 U.S.C. 552(a); the availability of this
incorporation by reference is given in paragraph (a)(3) of this
section), using xylene-ethyl alcohol in a 2:1 ratio instead of ethyl
alcohol in the preparation of potassium hydroxide solution.
(4) Ultraviolet absorbance limits specified in paragraph (a)(4) of
this section, as determined by the analytical method described therein.
[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11848, Mar. 19, 1982;
49 FR 10113, Mar. 19, 1984; 51 FR 33895, Sept. 24, 1986; 54 FR 24898,
June 12, 1989; 55 FR 28020, July 9, 1990; 58 FR 17512, Apr. 5, 1993]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3780]
[Page 427-428]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3780 Polyhydric alcohol esters of long chain monobasic acids.
Polyhydric alcohol esters of long chain monobasic acids identified
in this section may be safely used as lubricants in the fabrication of
polyvinyl chloride and/or polyvinyl chloride copolymer articles
complying with Sec. 177.1980 of this chapter that contact food of Types
I, II, IV-B, VI-B, VII-B, and VIII identified in table 1 in
Sec. 176.170(c) of this chapter under conditions of use E, F, and G
described in table 2 in Sec. 176.170(c) of this chapter, subject to the
provisions of this section.
(a) Identity. For the purpose of this section, polyhydric alcohol
esters of long chain monobasic acids consist of polyhydric alcohol
esters having number average molecular weights in the range of 1,050 to
1,700. The esters are produced by the reaction of either ethylene glycol
or glycerol with long chain monobasic acids containing from 9 to 49
carbon atoms obtained by the ozonization of long chain alpha-olefins,
the unreacted carboxylic acids in the formation of the glycerol esters
being neutralized with calcium hydroxide to produce a composition having
up to 2 percent by weight calcium. The alpha-olefins, obtained from the
polymerization of ethylene, have 20 to 50 carbon atoms and contain a
minimum of 75 percent by weight straight chain alpha-olefins and not
more than 25 percent vinylidene compounds.
(b) Specifications. The polyhydric alcohol esters have the following
specifications:
(1) Melting point of 60-80 deg.C for the ethylene glycol ester and
90-105 deg.C for the glycerol ester as determined by the Fisher Johns
method as described in "Semimicro Qualitative Organic Analysis--The
Systematic Identification of Organic Compounds," by Cheronis and
Entrikin, 2d Ed., Interscience Publishers, NY, which is incorporated by
reference. Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or available for inspection at the
Office
[[Page 428]]
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(2) Acid value 15-25 for each ester as determined by the A.O.C.S.
method Trla-64T "Titer Test," which is incorporated by reference.
Copies are available from American Association of Oil Chemists, 36 East
Wacker Drive, Chicago, IL 60601, or available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408. The method is modified to use as the acid
solvent a 1:1 volume mixture of anhydrous isopropyl alcohol and toluene.
The solution is titrated with 0.1N methanolic sodium hydroxide.
(3) Saponification value 120-160 for the ethylene glycol ester and
90-130 for the glycerol ester as determined the A.O.C.S. method Trla-64T
"Saponification Value," which is incorporated by reference. Copies are
available from American Association of Oil Chemists, 36 East Wacker
Drive, Chicago, IL 60601, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(4) Ultraviolet absorbance as specified in Sec. 178.3770(a)(4) of
this chapter when tested by the analytical method described therein.
[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11849, Mar. 19, 1982;
54 FR 24899, June 12, 1989; 61 FR 14481, Apr. 2, 1996]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3790]
[Page 428-429]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3790 Polymer modifiers in semirigid and rigid vinyl chloride plastics.
The polymers identified in paragraph (a) of this section may be
safely admixed, alone or in mixture with other permitted polymers, as
modifiers in semirigid and rigid vinyl chloride plastic food-contact
articles prepared from vinyl chloride homopolymers and/or from vinyl
chloride copolymers complying with Sec. 177.1950, Sec. 177.1970, and/or
Sec. 177.1980 of this chapter, in accordance with the following
prescribed conditions:
(a) For the purpose of this section, the polymer modifiers are
identified as follows:
(1) Acrylic polymers identified in this subparagraph provided that
such polymers contain at least 50 weight-percent of polymer units
derived from one or more of the monomers listed in paragraph (a)(1)(i)
of this section.
(i) Homopolymers and copolymers of the following monomers:
n-Butyl acrylate.
n-Butyl methacrylate.
Ethyl acrylate.
Methyl methacrylate.
(ii) Copolymers produced by copolymerizing one or more of the
monomers listed in paragraph (a)(1)(i) of this section with one or more
of the following monomers:
Acrylonitrile.
Butadiene.
a-Methylstyrene.
Styrene.
Vinylidene chloride.
(iii) Polymers identified in paragraphs (a)(1) (i) and (ii) of this
section containing no more than 5 weight-percent of total polymer units
derived by copolymerization with one or more of the following monomers:
Acrylic acid.
1,3-Butylene glycol dimethacrylate.
Divinylbenzene.
Methacrylic acid.
(iv) Mixtures of polymers identified in paragraph (a)(1) (i), (ii),
and (iii) of this section; provided that no chemical reactions, other
than addition reactions, occur when they are mixed.
(2) Polymers identified in paragraph (a)(1) of this section combined
during their polymerization with butadiene-styrene copolymers; provided
that no chemical reactions, other than addition reactions, occur when
they are combined. Such combined polymers may contain 50 weight-percent
or more of total polymer units derived from the butadiene-styrene
copolymers.
(b) The polymer content of the finished plastic food-contact article
consists of:
(1) Not less than 80 weight-percent of polymer units derived from
the vinyl chloride polymers identified in the introduction to this
section and not more than 5 weight-percent of polymer units derived from
polymers identified in paragraph (a)(1) of this section and may
optionally contain up to 15 weight-percent of polymer units derived from
butadiene-styrene copolymers; or
[[Page 429]]
(2) Not less than 50 weight-percent of polymer units derived from
the vinyl chloride polymers identified in the introduction to this
section, not more than 50 weight-percent of polymer units derived from
homopolymers and/or copolymers of ethyl acrylate and methyl
methacrylate, and not more than 30 weight-percent of polymer units
derived from copolymers of methyl methacrylate, a-methylstyrene and
acrylonitrile and may optionally contain up to 15 weight-percent of
polymer units derived from butadiene-styrene copolymers.
(c) No chemical reactions, other than addition reactions, occur
among the vinyl chloride polymers and the modifying polymers present in
the polymer mixture used in the manufacture of the finished plastic
food-contact article.
(d) The finished plastic food-contact article, when extracted with
the solvent or solvents characterizing the type of food and under the
conditions of time and temperature characterizing the conditions of its
intended use as determined from tables 1 and 2 of Sec. 176.170(c) of
this chapter, yields extractives not to exceed the limits prescribed in
Sec. 177.1010 (b) (1), (2), (3), and (4) of this chapter when tested by
the methods prescribed in Sec. 177.1010 (c) of this chapter.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3800]
[Page 429]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3800 Preservatives for wood.
Preservatives may be safely used on wooden articles that are used or
intended for use in packaging, transporting, or holding raw agricultural
products subject to the provisions of this section:
(a) The preservatives are prepared from substances identified in
paragraph (b) of this section and applied in amounts not to exceed those
necessary to accomplish the technical effect of protecting the wood from
decay, mildew, and water absorption.
(b) The substances permitted are as follows:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
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 Do.
by the homo- and copolymerization 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.
Rosins and rosin derivatives........... As provided in Sec. 178.3870.
Zinc salt of sulfonated petroleum......
------------------------------------------------------------------------
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3850]
[Page 429-430]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3850 Reinforced wax.
Reinforced wax may be safely used as an article or component of
articles intended for use in producing, manufacturing, packing,
processing, transporting, or holding food subject to the provisions of
this section.
(a) Reinforced wax consists of petroleum wax to which have been
added certain optional substances required in its production, or added
to impart desired physical or technical properties.
(b) The quantity of any optional adjuvant substance employed in the
production of or added to reinforced wax does not exceed the amount
reasonably required to accomplish the intended physical or technical
effect or any limitation provided in this section.
(c) Any substance employed in the production of reinforced wax,
including any optional substance, that is the subject of a regulation in
parts 174, 175, 176, 177, 178 and Sec. 179.45 of this chapter, conforms
with any specification in such regulation.
(d) The substances and optional adjuvant substances employed in the
production of or added to reinforced wax include:
(1) Substances generally recognized as safe in food.
(2) Substances subject to prior sanction for use in reinforced wax
and used
[[Page 430]]
in accordance with such sanction or approval.
(3) Substances identified in this subparagraph and subject to any
limitations provided therein:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Copolymer of isobutylene modified with
isoprene.
Petroleum wax, Type I and Type II.........
Polyethylene..............................
Rosins and rosin derivatives as provided
in Sec. 178.3870.
Synthetic wax polymer as described in Sec. Not to exceed 5 percent by
176.170(a)(5) of this chapter. weight of the petroleum
wax.
------------------------------------------------------------------------
(e) Reinforced wax conforming with the specifications in this
paragraph is used as provided in paragraph (e)(2) of this section.
(1) The chloroform-soluble portion of the water extract obtained by
exposing reinforced wax to demineralized water at 70 deg.F for 48 hours
shall not exceed 0.5 milligram per square inch of food-contact surface.
(2) It is used as a packaging material or component of packaging
materials for cheese and cheese products.
[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 1288, Jan. 12, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3860]
[Page 430]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3860 Release agents.
Substances listed in paragraph (b) of this section may be safely
used as release agents in petroleum wax complying with Sec. 178.3710 and
in polymeric resins that contact food, subject to the provisions of this
section.
(a) The quantity used shall not exceed the amount reasonably
required to accomplish the intended technical effect or any limitations
prescribed in this section.
(b) Release agents:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Erucamide (erucylamide).........
Formaldehyde, polymer with 1- For use only as an antiscaling or
naphthalenol (CAS Reg. No. release agent, applied on the
25359-91-5). internal 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
concentration 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; For use only subject to the
complying with the identity limitations prescribed for
prescribed under Sec. hydrogenated polybutene under Sec.
178.3740(b). 178.3740(b).
Poly(vinyl acetate/vinyl N- For use only in application to the
octadecylcarbamate) (CAS Reg. backing of pressuresensitive adhesive
No. 70892-21-6) produced by the tapes at levels not to exceed 0.2
reaction between milligram per square centimeter (1.29
stoichiometrically equivalent milligrams per square inch) of
amounts of octadecyl isocyanate backing.
and vinyl alcohol/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 Sec.
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
vegetable 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]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3870]
[Page 430-433]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3870 Rosins and rosin derivatives.
The rosins and rosin derivatives identified in paragraph (a) of this
section may safely be used in the manufacture of articles or components
of articles intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food, subject to the provisions of this section.
(a) The rosins and rosin derivatives are identified as follows:
(1) Rosins:
(i) Gum rosin, refined to color grade of K or paler.
(ii) Wood rosin, refined to color grade of K or paler.
[[Page 431]]
(iii) Tall oil rosin, refined to color grade of K or paler.
(iv) Dark tall oil rosin, a fraction resulting from the refining of
tall oil rosin produced by multicolumnar distillation of crude tall oil
to effect removal of fatty acids and pitch components and having a
saponification number of from 110-135 and 32 percent-44 percent rosin
acids.
(v) Dark wood rosin, all or part of the residue after the volatile
terpene oils are distilled from the oleoresin extracted from pine wood.
(2) Modified rosins manufactured from rosins identified in paragraph
(a)(1) of this section:
(i) Partially hydrogenated rosin, catalytically hydrogenated to a
maximum refractive index of 1.5012 at 100 deg.C, and a color of WG or
paler.
(ii) Fully hydrogenated rosin, catalytically hydrogenated to a
maximum dehydroabietic acid content of 2 percent, a minimum drop-
softening point of 79 deg.C, and a color of X or paler.
(iii) Partially dimerized rosin, dimerized by sulfuric acid catalyst
to a drop-softening point of 95 deg.-105 deg.C and a color of WG or
paler.
(iv) Fully dimerized rosin, dimerized by sulfuric acid catalyst, and
from which sufficient nondimerized rosin has been removed by
distillation to achieve a minimum drop-softening point of 143 deg.C,
and a color of H or paler.
(v) Disproportionated rosin, catalytically disproportionated to a
minimum dehydroabietic acid content of 35 percent, a maximum abietic
acid content of 1 percent, a maximum content of substituted
phenanthrenes (as retene) of 0.25 percent, and a color of WG or paler.
(3) Rosin esters manufactured from rosins and modified rosins
identified in paragraphs (a)(1) and (2) of this section:
(i) Glycerol ester of wood rosin purified by steam stripping to have
an acid number of 3 to 9, a drop-softening point of 88 deg.-96 deg.C,
and a color of N or paler.
(ii) Glycerol ester of partially hydrogenated wood rosin, having an
acid number of 3 to 10, a drop-softening point of 79 deg.-88 deg.C, and
a color of N or paler.
(iii) Glycerol ester of partially dimerized rosin, having an acid
number of 3 to 8, a drop-softening point of 109 deg.-119 deg.C, and a
color of M or paler.
(iv) Glycerol ester of fully dimerized rosin, having an acid number
of 5 to 16, a drop-softening point of 165 deg.-175 deg.C, and a color
of H or paler.
(v) Glycerol ester of maleic anhydride-modified wood rosin, having
an acid number of 30 to 40, a drop-softening point of 138 deg.-146
deg.C, a color of M or paler, and a saponification number less than 280.
(vi) Methyl ester of rosin, partially hydrogenated, purified by
steam stripping to have an acid number of 4 to 8, a refractive index of
1.5170 to 1.5205 at 20 deg.C, and a viscosity of 23 to 66 poises at 25
deg.C.
(vii) Pentaerythritol ester of wood rosin, having an acid number of
6 to 16, a drop-softening point of 109 deg.-116 deg.C, and a color of M
or paler.
(viii) Pentaerythritol ester of partially hydrogenated wood rosin,
having an acid number of 7 to 18, a drop-softening point of 102 deg.-110
deg.C, and a color of K or paler.
(ix) Pentaerythritol ester of maleic anhydride-modified wood rosin,
having an acid number of 8 to 16, a drop-softening point of 154 deg.-162
deg.C, a color of M or paler, and having a saponification number less
than 280.
(x) Pentaerythritol ester of maleic anhydride-modified wood rosin,
having an acid number of 9 to 16, a drop-softening point of 130 deg.-140
deg.C, a color of N or paler, and having a saponification number less
than 280.
(xi) Pentaerythritol ester of maleic anhydride-modified wood rosin,
having an acid number of 134 to 145, a drop-softening point of 127 deg.-
137 deg.C, a color of M or paler, and having a saponification number
less than 280.
(xii) Pentaerythritol ester of maleic anhydride-modified wood rosin,
having an acid number of 30 to 40, a drop-softening point of 131 deg.-
137 deg.C, a color of N or paler, and having a saponification number
less than 280.
(xiii) Pentaerythritol ester of maleic anhydride-modified wood
rosin, further modified by reaction with 4,4'-isopropyl-idenediphenol-
formaldehyde condensate, having an acid number of 10 to 22, a drop-
softening point of 162 deg.-172 deg.C, a color of K or paler, a
saponification number less than 280, and a
[[Page 432]]
maximum ultraviolet absorbance of 0.14 at 296 m[mu] (using a 1-
centimeter cell and 200 milligrams of the rosin ester per liter of
solvent consisting of ethyl alcohol made alkaline by addition of 0.1
percent of potassium hydroxide).
(xiv) Mixed methyl and pentaerythritol ester of maleic anhydride-
modified wood rosin, having an acid number of 73 to 83, a drop-softening
point of 113 deg.-123 deg.C, a color of M or paler, and a
saponification number less than 280.
(xv) Triethylene glycol ester of partially hydrogenated wood rosin,
having an acid number of 2 to 10, a color of K or paler, and a viscosity
of 350 to 425 seconds Saybolt at 100 deg.C.
(xvi) Glycerol ester of maleic anhydride-modified wood rosin, having
an acid number of 17 to 23, a drop-softening point of 136 deg.-140
deg.C, a color of M or paler, and a saponification number less than 280.
For use only in cellophane complying with Sec. 177.1200 of this chapter.
(xvii) Citric acid-modified glycerol ester of rosin, having an acid
number less than 20, a drop-softening point of 105 deg.-115 deg.C, and
a color of K or paler. For use only as a blending agent in coatings for
cellophane complying with Sec. 177.1200 of this chapter.
(xviii) Glycerol ester of tall oil rosin, purified by steam
stripping to have an acid number of 5-12, a softening point of 80 deg.-
88 deg.C, and a color of N or paler.
(xix) Glycerol ester of maleic anhydride-modified tall oil rosin,
having an acid number of 30 to 40, a drop-softening point of 141 deg.-
146 deg.C, a color of N or paler, and a saponification number less than
280.
(xx) Glycerol ester of disproportionated tall oil rosin, having an
acid number of 5 to 10, a drop-softening point of 84 deg.-93 deg.C, a
color of WG or paler, and a saponification number less than 180.
(4) Rosin salts and sizes--Ammonium, calcium, potassium, sodium, or
zinc salts of rosin manufactured by the partial or complete
saponification of any one of the rosins or modified rosins identified in
paragraph (a)(1) and (2) of this section, or blends thereof, and with or
without modification by reaction with one or more of the following:
(i) Formaldehyde.
(ii) Fumaric acid.
(iii) Maleic anhydride.
(iv) Saligenin.
(b) The quantity used shall not exceed the amount reasonably
required to accomplish the intended technical effect.
(c) The use in any substance or article that is the subject of a
regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this
chapter shall conform with any specifications and limitations prescribed
by such regulation for the finished form of the substance or article.
(d) The provisions of this section are not applicable to rosins and
rosin derivatives identified in Sec. 175.300(b)(3)(v) of this chapter
and used in resinous and polymeric coatings complying with Sec. 175.300
of this chapter.
(e) The provisions of this section are not applicable to rosins and
rosin derivatives identified in Sec. 175.105(c)(5) of this chapter and
used in defoaming agents complying with Sec. 176.210 of this chapter,
food-packaging adhesives complying with Sec. 175.105 of this chapter,
and rubber articles complying with Sec. 177.2600 of this chapter.
(f) The analytical methods for determining whether rosins and rosin
derivatives conform to the specifications prescribed in paragraph (a) of
this section are as follows:
(1) Color: Color shall be as determined by ASTM method D509-70
(Reapproved 1981), "Standard Methods of Sampling and Grading Rosin,"
which is incorporated by reference. Copies may be obtained from the
American Society for Testing Materials, 1916 Race St., Philadelphia, PA
19103, or may be examined at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408.
(2) Refractive index: Refractive index shall be as determined by
ASTM method D1747-62 (Reapproved 1978), "Standard Test Method for
Refractive Index of Viscous Materials," which is incorporated by
reference. The availability of this incorporation by reference is given
in paragraph (f)(1) of this section.
(3) Acid number: Acid number shall be as determined by ASTM method
D465-82, "Standard Test Methods for Acid Number of Rosin," which is
incorporated by reference. The availability of this incorporation by
reference is given in paragraph (f)(1) of this section.
[[Page 433]]
(4) Viscosity: Viscosity in poises shall be as determined by ASTM
method D1824-66 (Reapproved 1980), "Standard Test Method for Apparent
Viscosity of Plastisols and Organosols at Low Shear Rates by Brookfield
Viscometer," and in Saybolt seconds by ASTM method D88-81, "Standard
Test Method for Saybolt Viscosity," which are incorporated by
reference. The availability of this incorporation by reference is given
in paragraph (f)(1) of this section.
(5) Softening point: Softening point shall be as determined by ASTM
method E28-67, "Standard Test Method for Softening Point by Ring and
Ball Apparatus" (Reapproved 1977), which is incorporated by reference.
Copies are available from American Society for Testing and Materials
(ASTM), 1916 Race St., Philadelphia, PA 19103, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(6) Analytical methods for determining drop-softening point,
saponification number, and any other specifications not listed under
paragraphs (f)(1) through (5) of this section, titled: (i)
"Determination of Abeitic Acid and Dehydroabietic Acid in Rosins";
(ii) "Determination of Softening Point of Solid Resins"; (iii)
"Determination of Saponification Number of Rosin Esters," and (iv)
"Determination of Phenolic Modification of Rosin Derivatives," which
are incorporated by reference. Copies are available from the Center for
Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408.
[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11849, Mar. 19, 1982;
49 FR 10113, Mar. 19, 1984; 54 FR 24899, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3900]
[Page 433]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3900 Sodium pentachlorophenate.
Sodium pentachlorophenate may be safely used as a preservative for
ammonium alginate employed as a processing aid in the manufacture of
polyvinyl chloride emulsion polymers intended for use as articles or
components of articles that contact food at temperatures not to exceed
room temperature. The quantity of sodium pentachlorophenate used shall
not exceed 0.5 percent by weight of ammonium alginate solids.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3910]
[Page 433-439]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3910 Surface lubricants used in the manufacture of metallic articles.
The substances listed in this section may be safely used in surface
lubricants employed in the manufacture of metallic articles that contact
food, subject to the provisions of this section.
(a) The following substances may be used in surface lubricants used
in the rolling of metallic foil or sheet stock provided that total
residual lubricant remaining on the metallic article in the form in
which it contacts food does not exceed 0.015 milligram per square inch
of metallic food-contact surface:
(1) Substances identified in paragraphs (b)(1) and (2) of this
section.
(2) Substances identified in this paragraph.
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
[alpha]-Butyl-[Omega]--hydroxypoly
(oxyethylene)-poly (oxypropylene) (CAS
Reg. No. 9038-95-3) produced by random
condensation of a 1:1 mixture by
weight of ethylene oxide and propylene
oxide with butanol and having a
minimum molecular weight of 1,000.
[alpha]-Butyl-[Omega]-
hydroxypoly(oxypropylene) (CAS Reg.
No. 9003-13-8) having a minimum
molecular weight of 1000.
[alpha]-Lauroyl-[Omega]-
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 Sec. 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 alcohols with
an average of 3 moles of ethylene
oxide (CAS Reg. No. 6002-97-1).
Benzotriazole (CAS Reg. No. 95-14-7)...
[[Page 434]]
Bis(hydrogenated tallow alkyl)amine Not to be used in combination
(CAS Reg. No. 61789-79-5). with sodium nitrite.
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 For use only at a level not to
methyl esters; such dimers and trimers exceed 10 percent by weight of
are of unsaturated C18 fatty acids finished lubricant
derived from animal and vegetable fats formulation.
and oils and/or tall oil, and such
partial methyl esters meet the
following specifications:
Saponification value 180-200, acid
value 70-130, and maximum iodine value
120.
Di-n-octyl sebacate....................
Ethylenediaminetetraacetic acid, sodium
salts.
Isopropyl alcohol......................
Isopropyl laurate (CAS Reg. No. 10233- For use at a level not to
13-3). 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 prescribed under
Sec. 178.3740(b).
Polyethylene glycol (400) monostearate.
Polyisobutylene (minimum molecular
weight 300).
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 provided 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. 68608-24-4) derived from
naphthenic oil having a Saybolt
viscosity range of 500-600 Saybolt
Universal Seconds (SUS at 37-8 deg.C
(100 deg.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 Office of the
Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC
20408.
Synthetic alcohol mixture of straight-
and branched-chain alcohols 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 alcohols and
contains not less than 85 pct total
C10 and C12 alcohols.
Synthetic primary alcohol mixture of For use at a level not to
straight- and branched-chain alcohols exceed 8 pct by weight of the
that contain at least 99 pct primary finished lubricant
alcohols consisting of the following: formulation.
not less than 70 pct normal alcohols;
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
fraction, carbon monoxide and hydrogen
using a modified oxo process, such
that the finished primary alcohol
mixture meets the following
specifications: Molecular weight,
2074; hydroxyl number, 266-
276.
Synthetic primary alcohol mixture of For use only at a level not to
straight- and branched-chain alcohols exceed 8 pct by weight of the
that contain at least 99 pct primary finished lubricant
alcohols consisting of the following: formulation.
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 monoxide and hydrogen
using a modified oxo process, such
that the finished primary alcohol
mixture meets the following
specifications:
Molecular weight 1945;
hydroxyl number, 283-296.
[[Page 435]]
Tallow, sulfonated.....................
Triethanolamine........................
------------------------------------------------------------------------
(3) Mineral oil conforming to the identity prescribed in
Sec. 178.3620(c).
(4) Light petroleum hydrocarbons identified in paragraph (a)(4) (i)
of this section: Provided, That the total residual lubricant on the
metallic article in the form in which it contacts food meets the
ultraviolet absorbance limits prescribed in paragraph (a) (4) (ii) of
this section as determined by the analytical method described in
paragraph (a) (4) (iii) of this section.
(i) Light petroleum hydrocarbons are derived by distillation from
virgin petroleum stocks or are synthesized from petroleum gases. They
are chiefly paraffinic, isoparaffinic, napthenic, or aromatic in nature,
and meet the following specifications:
(a) Initial boiling point is 24 deg.C minimum and final boiling
point is 288 deg.C maximum, as determined by ASTM method D86-82,
"Standard Method for Distillation of Petroleum Products," which is
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(b) Nonvolatile residue is 0.005 gram per 100 milliliters, maximum,
as determined by ASTM method D381-80, "Standard Test Method for
Existent Gum in Fuels by Jet Evaporation," when the final boiling point
is 121 deg.C or above and by ASTM method D1353-78, "Standard Test
Method for Nonvolatile Matter in Volatile Solvents for Use in Paint,
Varnish, Lacquer, and Related Products," when the final boiling point
is below 121 deg.C. These ASTM methods are incorporated by reference.
The availability of these incorporations by reference is given in
paragraph (a)(4)(i)(a) of this section.
(c) Saybolt color 20 minimum as determined by ASTM method D156-82,
"Standard Test Method for Saybolt Color of Petroleum Products (Saybolt
Chromometer Method)," which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(a)(4)(i)(a) of this section.
(d) Aromatic component content shall not exceed 32 percent.
(e) Conforms with ultraviolet absorbance limits prescribed in
Sec. 178.3620(c) as determined by the analytical method described
therein.
(ii) Ultraviolet absorbance limits on residual lubricants are as
follows:
------------------------------------------------------------------------
Maximum
absorbance
per 5
Wavelength (m[mu]) centimeters
optical
pathlength
------------------------------------------------------------------------
280-289.................................................... 0.7
290-299.................................................... .6
300-359.................................................... .4
360-400.................................................... .09
------------------------------------------------------------------------
(iii) The analytical method for determining ultraviolet absorbance
limits on residual lubricants is as follows:
general instructions
Because of the sensitivity of the test, the possibility of errors
arising from contamination is great. It is of the greatest importance
that all glassware be scrupulously cleaned to remove all organic matter
such as oil, grease, detergent, residues, etc. Examine all glassware
including stoppers and stopcocks, under ultraviolet light to detect any
residual fluorescent contamination. As a precautionary measure it is
recommended practice to rinse all glassware with purified isooctane
immediately before use. No grease is to be used on stopcocks or joints.
Great care to avoid contamination of oil samples in handling and to
assure absence of any extraneous material arising from inadequate
packaging is essential. Because some of the polynuclear hydrocarbons
sought in this test are very susceptible to photo-oxidation, the entire
procedure is to be carried out under subdued light.
apparatus
Separatory funnels. 250-milliliter, 500-milliliter, 1,000-
milliliter, and preferably 2,000-milliliter capacity, equipped with
tetrafluoroethylene polymer stopcocks.
Evaporation flask (optional). 250-milliliter or 500-milliliter
capacity all-glass flask
[[Page 436]]
equipped with standard-taper stopper having inlet and outlet tubes to
permit passage of nitrogen across the surface of contained liquid to be
evaporated.
Spectrophotometric cells. Fused quartz cells, optical path length in
the range of 5,000 centimeters 0.005 centimeter; also for
checking spectrophotometer performance only, optical path length in the
range 1.000 centimeter 0.005 centimeter. With distilled
water in the cells, determine any absorbance differences.
Spectrophotometer. Special range 250 millicrons-400 millimicrons
with spectral slit width of 2 millimicrons or less; under instrument
operating conditions for these absorbance measurements, the
spectrophotometer shall also meet the following performance
requirements:
Absorbance repeatability, 0.01 at 0.4 absorbance.
Absorbance accuracy, \1\ 0.05 at 0.4 absorbance.
---------------------------------------------------------------------------
\1\ As determined by procedure using potassium chromate for
reference standard and described in National Bureau of Standards
Circular 484, Spectrometry, U.S. Department of Commerce (1949), which is
incorporated by reference. Copies are available from the Center for Food
Safety and Applied Nutrition (HFS-200), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408. The accuracy is to be
determined by comparison with the standard values at 210, 345, and 400
millimicrons.
---------------------------------------------------------------------------
Wavelength repeatability, 0.2 millimicron.
Wavelength accuracy, 1.0 millimicron.
Soxhlet apparatus. 60-millimeter diameter body tubes fitted with
condenser and 500-milliliter round-bottom boiling flask. A supply of
paper thimbles to fit is required.
Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in
cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.
reagents and materials
Organic solvents. All solvents used throughout the procedure shall
meet the specifications and tests described in this specification. The
isooctane (2,2,4-trimethylpentane) shall pass the following test:
Place 180 milliliters of solvent in a 250-milliliter Erlenmeyer
flask, add 1 milliliter of purified n-hexadecane and evaporate on the
steam bath under a stream of nitrogen (a loose aluminum foil jacket
around the flask will speed evaporation). Discontinue evaporation when
not over 1 milliliter of residue remains.
Alternatively, the evaporation time can be reduced by using the
optional evaporation flask. In this case the solvent and n-hexadecane
are placed in the flask on the steam bath, the tube assembly is
inserted, and a stream of nitrogen is fed through the inlet tube while
the outlet tube is connected to a solvent trap and vacuum line in such a
way as to prevent any flow-back of condensate into the flask.
Dissolve the 1 milliliter of hexadecane residue in isooctane and
make to 25 milliliters volume. Determine the absorbance in the 5-
centimeter path length cells compared to isooctane as reference. The
absorbance of the solution of the solvent residue shall not exceed 0.01
per centimeter path length between 280 and 400 m[mu]. Purify, if
necessary, by passage through a column of activated silica gel (Grade
12, Davison Chemical Co., Baltimore, Maryland, or equivalent) about 90
centimeters in length and 5 centimeters to 8 centimeters in diameter.
n-Hexadecane, 99-percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 25 milliliters with isooctane and determine the absorbance
in a 5-centimeter cell compared to isooctane as reference point between
280 m[mu]-400 m[mu]. The absorbance per centimeter path length shall not
exceed 0.00 in this range. Purify, if necessary, by percolation through
activated silica gel or by distillation.
Dimethyl sulfoxide. Spectrophotometric grade (Crown Zellerbach
Corp., Camas, Washington, or equivalent). Absorbance (1-centimeter cell,
distilled water reference, sample completely saturated with nitrogen).
------------------------------------------------------------------------
Absorbance
Wavelength (maximum)
------------------------------------------------------------------------
261.5....................................................... 1.00
270......................................................... .20
275......................................................... .09
280......................................................... .06
300......................................................... .015
------------------------------------------------------------------------
There shall be no irregularities in the absorbance curve within
these wavelengths.
Phosphoric acid. 85 percent A.C.S. reagent grade.
Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in
granular form. For each bottle of sodium sulfate reagent used, establish
as follows the necessary sodium sulfate prewash to provide such filters
required in the method: Place approximately 35 grams of anhydrous sodium
sulfate in a 30-milliliter coarse, fritted-glass funnel or in a 65-
milliliter filter funnel with glass wool plug; wash with successive 15-
milliliter portions of the indicated solvent until a 15-milliliter
portion of the wash shows 0.00 absorbance per centimeter path length
between 280 m[mu] and 400 m[mu] when tested as prescribed under
"Organic solvents." Usually three portions of wash solvent are
sufficient.
[[Page 437]]
Before proceeding with analysis of a sample, determine the
absorbance in a 5-centimeter path cell between 250 millimicrons and 400
millimicrons for the reagent blank by carrying out the procedure,
without a metal sample. The absorbance per centimeter path length should
not exceed 0.02 in the wavelength range from 280 m[mu] to 400 m[mu].
Place 300 milliliters of dimethyl sulfoxide in a 1-liter separatory
funnel and add 75 milliliters of phosphoric acid. Mix the contents of
the funnel and allow to stand for 10 minutes. (The reaction between the
sulfoxide and the acid is exothermic. Release pressure after mixing,
then keep funnel stoppered.) Add 150 milliliters of isooctane and shake
to pre-equilibrate the solvents. Draw off the individual layers and
store in glass-stoppered flasks.
procedure
Sample. Select metal foil or sheet stock for the test which has not
been previously contaminated by careless handling or exposure to
atmospheric dust and fumes. A commercial coil in the form supplied for
spindle mounting in a packaging line or wrapping machine is most
suitable. Strip off the outside turn of metal and discard. Carefully
avoid contamination or damage from handling the metal (wear gloves).
Remove a 16-18-foot length from the coil and place it on a flat surface
protected by a length of new kraft paper. Cut four 15-foot strips from
the sample, each 3 inches wide (avoid tearing the edges of the strips).
Using a piece of suitable glass rod, roll the strips of metal into loose
coils and insert each into a Soxhlet thimble. Each turn of coil should
be visibly separated from the adjacent turn.
Extraction. Fill each of the four Soxhlet tubes with purified
isooctane (see under heading "Reagents and Materials," above) until
siphon action occurs and then refill the tube body. Supply heat to the
boiling flask and allow extraction to continue for at least 8 hours or
until repeated weighings of the dried and cooled coil show no further
weight loss.
Combine the isooctane extracts from the four Soxhlet units in a
suitable beaker, rinsing each tube and flask into the beaker with fresh
purified solvent. Evaporate the solvent under an atmosphere of inert gas
(nitrogen) to residual volume of 50-60 milliliters and transfer this
solution to a 500-milliliter separatory funnel containing 100
milliliters of pre-equilibrated sulfoxide-phosphoric acid mixture.
Complete the transfer of the sample with small portions of pre-
equilibrated isooctane to give a total volume of the residue and solvent
of 75 milliliters. Shake the funnel vigorously for 2 minutes. Set up
three 250-milliliter separatory funnels with each containing 30
milliliters of pre-equilibrated isooctane. After separation of liquid
phases, carefully draw off lower layer into the first 250-milliliter
separatory funnel and wash in tandem with the 30-milliliter portion of
isooctane contained in the 250-milliliter separatory funnels. Shaking
time for each wash is 1 minute. Repeat the extraction operation with two
additional portions of the sulfoxide-acid mixture and wash each
extractive in tandem through the same three portions of isooctane.
Collect the successive extractives (300 milliliters total) in a
separatory funnel (preferably 2-liter) containing 480 milliliters of
distilled water; mix, and allow to cool for a few minutes after the last
extractive has been added. Add 80 milliliters of isooctane to the
solution and extract by shaking the funnel vigorously for 2 minutes.
Draw off the lower aqueous layer into a second separatory funnel
(preferably 2-liter) and repeat the extraction with 80 milliliter of
isooctane. Draw off and discard the aqueous layer. Wash each of the 80
milliliter extractives three times with 100-milliliter portions
distilled water. Shaking time for each wash is 1 minute. Discard the
aqueous layers. Filter the first extractive through anhydrous sodium
sulfate pre-washed with isooctane (see sodium sulfate under "Reagents
and Materials" for preparation of filter) into a 250-milliliter
Erlenmeyer flask (or optionally into the evaporation flask). Wash the
first separatory funnel with the second 80-milliliter isooctane
extractive and pass through the sodium sulfate. Then wash the second and
first separatory funnels successively with a 20-milliliter portion of
isooctane and pass the solvent through the sodium sulfate into the
flask. Add 1 milliliter of n-hexadecane and evaporate the isooctane on
the steam bath under nitrogen. Discontinue evaporation when not over 1
milliliter of residue remains. To the residue, add a 10-milliliter
portion of isooctane, reevaporate to 1 milliliter of hexadecane, and
repeat this operation once.
Quantitatively transfer the residue with isooctane to a 25-
milliliter volumetric flask, make to volume, and mix. Determine the
absorbance of the solution in 5-centimeter pathlength cells compared to
isooctane as reference between 280m[mu]-400m[mu] (take care to lose none
of the solution in filling the sample cell). Correct the absorbance
values for any absorbance derived from reagents as determined by
carrying out the procedure without a metal sample. If the corrected
absorbance does not exceed the limits prescribed in this paragraph, the
residue meets the ultraviolet absorbance specifications.
(b) The following substances may be used in surface lubricants used
to facilitate the drawing, stamping, or forming of metallic articles
from rolled foil or sheet stock by further processing provided that the
total residual
[[Page 438]]
lubricant remaining on the metallic article in the form in which it
contacts food does not exceed 0.2 milligram per square inch of food-
contact surface:
(1) Antioxidants used in compliance with regulations in parts 170
through 189 of this chapter.
(2) Substances identified in this subparagraph.
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
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 Sec. 181.28 of
this chapter.
Dipropylene glycol.....................
Epoxidized soybean oil................. Conforming to the identity
prescribed in Sec. 181.27 of
this chapter.
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 Sec. 178.3620
(a) or (b).
Mono-, di-, and tristearyl citrate.....
Oleic acid amide.......................
Palmitic acid amide....................
Petrolatum............................. Conforming to the identity
prescribed in Sec. 178.3700.
Phosphoric acid, mono- and dihexyl For use only at levels not to
esters, compounds with exceed 0.5 percent by weight
tetramethylnonylamines and C11-14- of the finished surface
alkylamines (CAS Reg. No. 80939-62-4). lubricant formulation.
Polyethylene glycol (molecular weight Mono- and diethylene glycol
300 or greater). 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- For use at a level not to
hydroxyhydrocinnamate)] methane (CAS exceed 0.5 percent by weight
Registry No. 6683-19-8). of the finished surface
lubricant formulation.
Triethylene glycol..................... Diethylene glycol content not
to exceed 0.1 pct.
Wax, petroleum......................... Complying with Sec. 178.3710.
------------------------------------------------------------------------
(c) The substances identified in paragraph (a)(2) of this section
may be used in surface lubricants used to facilitate the drawing,
stamping, and forming of metallic articles from rolled foil and sheet
stock provided that total residual lubricant remaining on the metallic
article in the form in which it contacts food does not exceed 0.015
milligram per square inch of food-contact surface.
(d) Subject to any prescribed limitations, the quantity of surface
lubricant used in the manufacture of metallic articles shall not exceed
the least amount reasonably required to accomplish the intended
technical effect and shall not be intended to nor, in fact, accomplish
any technical effect in the food itself.
(e) The use of the surface lubricants in the manufacture of any
article that is the subject of a regulation in parts 174, 175, 176, 177,
178 and Sec. 179.45 of this chapter must comply with any specifications
prescribed by such regulation for the finished form of the article.
(f) Any substance that is listed in this section and the subject of
a regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this
chapter shall comply
[[Page 439]]
with any applicable specifications prescribed by such regulation.
[42 FR 14609, Mar. 15, 1977, as amended at 48 FR 238, Jan. 4, 1983; 49
FR 10113, Mar. 19, 1984; 49 FR 29579, July 23, 1984; 50 FR 36874, Sept.
10, 1985; 52 FR 10223, Mar. 31, 1987; 54 FR 6124, Feb. 8, 1989; 54 FR
24899, June 12, 1989; 56 FR 55456, Oct. 28, 1991; 57 FR 23953, June 5,
1992; 58 FR 17513, Apr. 5, 1993; 64 FR 47110, Aug. 30, 1999]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3930]
[Page 439]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3930 Terpene resins.
The terpene resins identified in paragraph (a) of this section may
be safely used as components of polypropylene film intended for use in
contact with food, and the terpene resins identified in paragraph (b) of
this section may be safely used as components of polyolefin film
intended for use in contact with food;
(a) Terpene resins consisting of the hydrogenated polymers of
terpene hydrocarbons obtainable from sulfate turpentine and meeting the
following specifications: Drop-softening point of 118 deg.-138 deg.C;
iodine value less than 20.
(b) Terpene resins consisting of polymers of beta-pinene and meeting
the following specifications: Acid value less than 1; saponification
number less than 1; color less than 4 on the Gardner scale as measured
in 50 percent mineral spirits solution.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3940]
[Page 439]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3940 Tetraethylene glycol di-(2-ethylhexoate).
Tetraethylene glycol di-(2-ethylhexoate) containing not more than 22
parts per million ethylene and/or diethylene glycols may be used at a
level not to exceed 0.7 percent by weight of twine as a finish on twine
to be used for tying meat provided the twine fibers are produced from
nylon resins complying with Sec. 177.1500 of this chapter.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3950]
[Page 439]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
Subpart D--Certain Adjuvants and Production Aids
Sec. 178.3950 Tetrahydrofuran.
Tetrahydrofuran may be safely used in the fabrication of articles
intended for packaging, transporting, or storing foods, subject to the
provisions of this section.
(a) It is used as a solvent in the casting of film from a solution
of polymeric resins of vinyl chloride, vinyl acetate, or vinylidene
chloride that have been polymerized singly or copolymerized with one
another in any combination, or it may be used as a solvent in the
casting of film prepared from vinyl chloride copolymers complying with
Sec. 177.1980 of this chapter.
(b) The residual amount of tetrahydrofuran in the film does not
exceed 1.5 percent by weight of film.
