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