4/22/23, 8:25 AM CFR - Code of Federal Regulations Title 21

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CFR - Code of Federal Regulations Title 21
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[Code of Federal Regulations]
[Title 21, Volume 3]
[CITE: 21CFR178.3570]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION (CONTINUED)
PART 178 -- INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND
SANITIZERS
Subpart D - Certain Adjuvants and Production Aids
Sec. 178.3570 Lubricants with incidental food contact.

Lubricants with incidental food contact may be safely used on machinery

used for producing, manufacturing, packing, processing, preparing,
treating, packaging, transporting, or holding food, subject to the
provisions of this section:
(a) The lubricants are prepared from one or more of the following
substances:
(1) Substances generally recognized as safe for use in food.
(2) Substances used in accordance with the provisions of a prior sanction
or approval.
(3) Substances identified in this paragraph (a)(3).
Substances Limitations
For use only as a
thickening agent in
mineral oil lubricants
Aluminum stearoyl benzoyl hydroxide
at a level not to exceed
10 pct by weight of the
mineral oil.
For use as a copper
deactivator at a level
N,N-Bis(2-ethylhexyl)-ar-methyl-1H-benzotriazole-
not to exceed 0.1
1-methanamine (CAS Reg. No. 94270-86-7)
percent by weight of the
lubricant.
BHA
BHT
[alpha]-Butyl-omega-hydroxypoly(oxyethylene)
poly(oxypropylene) produced by random condensation
Addition to food not to
of a 1:1 mixture by weight of ethylene oxide and
exceed 10 parts per
propylene oxide with butanol; minimum molecular
million.
weight 1,500; Chemical Abstracts Service Registry
No. 9038-95-3
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4/22/23, 8:25 AM CFR - Code of Federal Regulations Title 21
[alpha]-Butyl-omega-hydroxypoly(oxypropylene);
minimum molecular weight 1,500; Chemical Abstracts Do.
Service Registry No. 9003-13-8
Castor oil Do.
Castor oil, dehydrated Do.
Castor oil, partially dehydrated Do.
Dialkyldimethylammonium aluminum silicate (CAS
For use only as a
Reg. No. 68953-58-2), which may contain up to 7
gelling agent in mineral
percent by weight 1,6-hexanediol (CAS Reg. No.
oil lubricants at a
629-11-8), where the alkyl groups are derived from
level not to exceed 15
hydrogenated tallow fatty acids (C14-C18) and
percent by weight of the
where the aluminum silicate is derived from
mineral oil.
bentonite
Addition to food not to
Dimethylpolysiloxane (viscosity greater than 300
exceed 1 part per
centistokes)
million.
For use only as an
extreme pressure-
antiwear adjuvant at a
Di (n-octyl) phosphite (CAS Reg. No. 1809-14-9)
level not to exceed 0.5
percent by weight of the
lubricant.
For use only:
1. As a corrosion
inhibitor or rust
preventative in mineral
oil-bentonite lubricants
at a level not to exceed
2 percent by weight of
Disodium decanedioate (CAS Reg. No. 17265-14-4)
the grease.
2. As a corrosion
inhibitor or rust
preventative only in
greases at a level not
to exceed 2 percent by
weight of the grease.
For use only as a
chelating agent and
sequestrant at a level
Disodium EDTA (CAS Reg. No. 139-33-3) not to exceed 0.06
percent by weight of
lubricant at final use
dilution.
For use only as a
surfactant to improve
lubricity in lubricating
Ethoxylated resin phosphate ester mixture fluids complying with
consisting of the following compounds: this section at a level
not to exceed 5 percent
by weight of the
lubricating fluid.
1. Poly(methylene-p-tert-butyl- phenoxy)poly-
(oxyethylene) mixture of dihydrogen phosphate
and monohydrogen phosphate esters (0 to 40
percent of the mixture). The resin is formed by
condensation of 1 mole of p-tert-butylphenol
with 2 to 4 moles of formaldehyde and
subsequent ethoxylation with 4 to 12 moles of
ethylene oxide;
2. Poly(methylene-p-nonylphenoxy)
poly(oxyethylene) mixture of dihydrogen
phosphate and monohydrogen phosphate esters (0

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4/22/23, 8:25 AM CFR - Code of Federal Regulations Title 21
to 40 percent of the mixture). The resin is
formed by condensation of 1 mole of p-
nonylphenol with 2 to 4 moles of formaldehyde
and subsequent ethoxylation with 4 to 12 moles
of ethylene oxide; and
3. n-Tridecyl alcohol mixture of dihydrogen
phosphate and monohydrogen phosphate esters (40
to 80 percent of the mixture; CAS Reg. No.
56831-62-0)
Fatty acids derived from animal or vegetable
sources, and the hydrogenated forms of such fatty
acids
For use at levels not to
2-(8-Heptadecenyl)-4,5-dihydro-1H-imidazole-1-
exceed 0.5 percent by
ethanol (CAS Reg. No. 95-38-5)
weight of the lubricant.
For use as an
antioxidant at levels
Hexamethylenebis(3,5-di-tert-butyl-4-
not to exceed 0.5
hydroxyhydrocinnamate) (CAS Reg. No. 35074-77-2)
percent by weight of the
lubricant.
[alpha]-Hydro-omega-hydroxypoly (oxyethylene)
poly(oxypropylene) produced by random condensation
Addition to food not to
of mixtures of ethylene oxide and propylene oxide
exceed 10 parts per
containing 25 to 75 percent by weight of ethylene
million.
oxide; minimum molecular weight 1,500; Chemical
Abstracts Service Registry No. 9003-11-6
12-Hydroxystearic acid
For use only as an
adjuvant (to improve
Isopropyl oleate
lubricity) in mineral
oil lubricants.
For use only as an
adjuvant in mineral oil
lubricants at a level
Magnesium ricinoleate
not to exceed 10 percent
by weight of the mineral
oil.
Addition to food not to
Mineral oil exceed 10 parts per
million.
For use as a corrosion
N-Methyl-N-(1-oxo-9- octadecenyl)glycine (CAS Reg. inhibitor at levels not
No. 110-25-8) to exceed 0.5 percent by
weight of the lubricant.
For use only as an
antioxidant at levels
N-phenylbenzenamine, reaction products with 2,4,4-
not to exceed 0.5
trimethylpentene (CAS Reg. No. 68411-46-1)
percent by weight of the
lubricant.
Complying with §
178.3700. Addition to
Petrolatum
food not to exceed 10
parts per million.
For use only, singly or
in combination, as
antioxidant in mineral
oil lubricants at a
Phenyl-[alpha]-and/or phenyl-[beta]-naphthylamine
level not to exceed a
total of 1 percent by
weight of the mineral
oil.

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For use only as an
Phosphoric acid, mono- and dihexyl esters,
adjuvant at levels not
compounds with tetramethylnonylamines and C11-14
to exceed 0.5 percent by
alkylamines
weight of the lubricant.
For use only as a
corrosion inhibitor or
Phosphoric acid, mono- and diisooctyl esters, rust preventative
reacted with tert-alkyl and (C12-C14) primary inlubricants at a level
amines (CAS Reg. No. 68187-67-7) not to exceed 0.5
percent by weight of the
lubricant.
For use only as an
extreme pressure-
Phosphorothioic acid, O, O, O-triphenyl ester, antiwear adjuvant at a
tert-butyl derivatives (CAS Reg. No. 192268-65-8) level not to exceed 0.5
percent by weight of the
lubricant.
For use only as an
Polyurea, having a nitrogen content of 9-14
adjuvant in mineral oil
percent based on the dry polyurea weight, produced
lubricants at a level
by reacting tolylene diisocyanate with tall oil
not to exceed 10 percent
fatty acid (C16 and C18) amine and ethylene
by weight of the mineral
diamine in a 2:2:1 molar ratio
oil.
Addition to food not to
Polybutene (minimum average molecular weight
exceed 10 parts per
80,000)
million.
Polybutene, hydrogenated; complying with the
Do.
identity prescribed under § 178.3740
Polyethylene Do.
For use only as a
Polyisobutylene (average molecular weight 35,000-
thickening agent in
140,000 (Flory))
mineral oil lubricants.
For use only as a rust
preventive in mineral
oil lubricants at a
Sodium nitrite
level not to exceed 3
percent by weight of the
mineral oil.
For use only as an
antioxidant in
Tetrakis[methylene(3,5-di-tert-butyl-4-
lubricants at a level
hydroxyhydro-cinnamate)]methane (CAS Reg. No.
not to exceed 0.5
6683-19-8)
percent by weight of the
lubricant.
For use as an
antioxidant at levels
Thiodiethylenebis (3,5-di-tert-butyl-4-
not to exceed 0.5
hydroxyhydrocinnamate) (CAS Reg. No. 41484-35-9)
percent by weight of the
lubricant.
For use only as an
extreme pressure-
Tri[2(or 4)-C9-10-branched
antiwear adjuvant at
alkylphenyl]phosphorothioate (CAS Reg. No. 126019-
levels not to exceed 0.5
82-7)
percent by weight of the
lubricant.
For use as an adjuvant
in lubricants herein
Triphenyl phosphorothionate (CAS Reg. No. 597-82-
listed at a level not to
0)
exceed 0.5 percent by
weight of the lubricant.
Tris(2,4-di-tert-butylphenyl)phosphite (CAS Reg. For use only as a
NO. 31570-04-4) stabilizer at levels not

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4/22/23, 8:25 AM CFR - Code of Federal Regulations Title 21
to exceed 0.5 percent by
weight of the lubricant.
For use as an
antioxidant at levels
Thiodiethylenebis(3,5-di-tert-butyl-4-hydroxy-
not to exceed 0.5
hydro- cinnamate) (CAS Reg. No. 41484-35-9)
percent by weight of the
lubricant.
For use at levels not to
Zinc sulfide exceed 10 percent by
weight of the lubricant.
(b) The lubricants are used on food-processing equipment as a protective
antirust film, as a release agent on gaskets or seals of tank closures, and
as a lubricant for machine parts and equipment in locations in which there
is exposure of the lubricated part to food. The amount used is the minimum
required to accomplish the desired technical effect on the equipment, and
the addition to food of any constituent identified in this section does not
exceed the limitations prescribed.
(c) Any substance employed in the production of the lubricants described in
this section that is the subject of a regulation in parts 174, 175, 176,
177, 178 and § 179.45 of this chapter conforms with any specification in
such regulation.
[42 FR 14609, Mar. 15, 1977]
Editorial Note:
For Federal Register citations affecting § 178.3570, see the List of CFR
Sections Affected, which appears in the Finding Aids section of the printed
volume and at www.govinfo.gov.

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