Lubricants with incidental food contact may be safely used on machinery used for producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section:
(a) The lubricants are prepared from one or more of the following substances:
(1) Substances generally recognized as safe for use in food.
(2) Substances used in accordance with the provisions of a prior sanction or approval.
(3) Substances identified in this paragraph (a)(3). ------------------------------------------------------------------------
Substances Limitations------------------------------------------------------------------------Aluminum stearoyl benzoyl hydroxide.... For use only as a thickening
agent in mineral oil
lubricants at a level not to
exceed 10 pct by weight of the
mineral oil.N,N-Bis(2-ethylhexyl)-ar-methyl-1H- For use as a copper deactivator
benzotriazole-1-methanamine (CAS Reg. at a level not to exceed 0.1
No. 94270-86-7). percent by weight of the
lubricant.BHA....................................BHT....................................[alpha]-Butyl-omega- Addition to food not to exceed
hydroxypoly(oxyethylene) 10 parts per million.
poly(oxypropylene) produced by random
condensation of a 1:1 mixture by
weight of ethylene oxide and propylene
oxide with butanol; minimum molecular
weight 1,500; Chemical Abstracts
Service Registry No. 9038-95-3.[alpha]-Butyl-omega- Do.
hydroxypoly(oxypropylene); minimum
molecular weight 1,500; Chemical
Abstracts Service Registry No. 9003-13-
8.Castor oil............................. Do.Castor oil, dehydrated................. Do.Castor oil, partially dehydrated....... Do.Dialkyldimethylammonium aluminum For use only as a gelling agent
silicate (CAS Reg. No. 68953-58-2), in mineral oil lubricants at a
which may contain up to 7 percent by level not to exceed 15 percent
weight 1,6-hexanediol (CAS Reg. No. by weight of the mineral oil.
629-11-8), where the alkyl groups are
derived from hydrogenated tallow fatty
acids (C14-C18) and where the aluminum
silicate is derived from bentonite.Dimethylpolysiloxane (viscosity greater Addition to food not to exceed
than 300 centistokes). 1 part per million.Di (n-octyl) phosphite (CAS Reg. No. For use only as an extreme
1809-14-9). pressure-antiwear adjuvant at
a level not to exceed 0.5
percent by weight of the
lubricant.Disodium decanedioate (CAS Reg. No. For use only:
17265-14-4). 1. As a corrosion inhibitor or
rust preventative in mineral
oil-bentonite lubricants at a
level not to exceed 2 percent
by weight of the grease.
2. As a corrosion inhibitor or
rust preventative only in
greases at a level not to
exceed 2 percent by weight of
the grease.Disodium EDTA (CAS Reg. No. 139-33-3).. For use only as a chelating
agent and sequestrant at a
level not to exceed 0.06
percent by weight of lubricant
at final use dilution.Ethoxylated resin phosphate ester For use only as a surfactant to
mixture consisting of the following improve lubricity in
compounds: lubricating fluids complying
with this section at a level
not to exceed 5 percent by
weight of the lubricating
fluid.
1. Poly(methylene-p-tert-butyl-
phenoxy)poly-(oxyethylene) mixture
of dihydrogen phosphate and
monohydrogen phosphate esters (0 to
40 percent of the mixture). The
resin is formed by condensation of 1
mole of p-tert-butylphenol with 2 to
4 moles of formaldehyde and
subsequent ethoxylation with 4 to 12
moles of ethylene oxide;.
2. Poly(methylene-p-nonylphenoxy)
poly(oxyethylene) mixture of
dihydrogen phosphate and
monohydrogen phosphate esters (0 to
40 percent of the mixture). The
resin is formed by condensation of 1
mole of p-nonylphenol with 2 to 4
moles of formaldehyde and subsequent
ethoxylation with 4 to 12 moles of
ethylene oxide; and.
3. n-Tridecyl alcohol mixture of
dihydrogen phosphate and
monohydrogen phosphate esters (40 to
80 percent of the mixture; CAS Reg.
No. 56831-62-0).Fatty acids derived from animal or
vegetable sources, and the
hydrogenated forms of such fatty acids.2-(8-Heptadecenyl)-4,5-dihydro-1H- For use at levels not to exceed
imidazole-1-ethanol (CAS Reg. No. 95- 0.5 percent by weight of the
38-5). lubricant.Hexamethylenebis(3,5-di-tert-butyl-4- For use as an antioxidant at
hydroxyhydrocinnamate) (CAS Reg. No. levels not to exceed 0.5
35074-77-2). percent by weight of the
lubricant.
[alpha]-Hydro-omega-hydroxypoly Addition to food not to exceed
(oxyethylene) poly(oxypropylene) 10 parts per million.
produced by random condensation of
mixtures of ethylene oxide and
propylene oxide containing 25 to 75
percent by weight of ethylene oxide;
minimum molecular weight 1,500;
Chemical Abstracts Service Registry
No. 9003-11-6.12-Hydroxystearic acid.................Isopropyl oleate....................... For use only as an adjuvant (to
improve lubricity) in mineral
oil lubricants.Magnesium ricinoleate.................. For use only as an adjuvant in
mineral oil lubricants at a
level not to exceed 10 percent
by weight of the mineral oil.Mineral oil............................ Addition to food not to exceed
10 parts per million.N-Methyl-N-(1-oxo-9- For use as a corrosion
octadecenyl)glycine (CAS Reg. No. 110- inhibitor at levels not to
25-8). exceed 0.5 percent by weight
of the lubricant.N-phenylbenzenamine, reaction products For use only as an antioxidant
with 2,4,4-trimethylpentene (CAS Reg. at levels not to exceed 0.5
No. 68411-46-1). percent by weight of the
lubricant.Petrolatum............................. Complying with Sec. 178.3700.
Addition to food not to exceed
10 parts per million.Phenyl-[alpha]-and/or phenyl-[beta]- For use only, singly or in
naphthylamine. combination, as antioxidant in
mineral oil lubricants at a
level not to exceed a total of
1 percent by weight of the
mineral oil.Phosphoric acid, mono- and dihexyl For use only as an adjuvant at
esters, compounds with levels not to exceed 0.5
tetramethylnonylamines and C11-14 percent by weight of the
alkylamines. lubricant.Phosphoric acid, mono- and diisooctyl For use only as a corrosion
esters, reacted with tert-alkyl and inhibitor or rust preventative
(C12-C14) primary amines (CAS Reg. No. inlubricants at a level not to
68187-67-7). exceed 0.5 percent by weight
of the lubricant.Phosphorothioic acid, O, O, O-triphenyl For use only as an extreme
ester, tert-butyl derivatives (CAS pressure-antiwear adjuvant at
Reg. No. 192268-65-8). a level not to exceed 0.5
percent by weight of the
lubricant.Polyurea, having a nitrogen content of For use only as an adjuvant in
9-14 percent based on the dry polyurea mineral oil lubricants at a
weight, produced by reacting tolylene level not to exceed 10 percent
diisocyanate with tall oil fatty acid by weight of the mineral oil.
(C16 and C18) amine and ethylene
diamine in a 2:2:1 molar ratio.Polybutene (minimum average molecular Addition to food not to exceed
weight 80,000). 10 parts per million.Polybutene, hydrogenated; complying Do.
with the identity prescribed under
Sec. 178.3740.Polyethylene........................... Do.Polyisobutylene (average molecular For use only as a thickening
weight 35,000-140,000 (Flory)). agent in mineral oil
lubricants.Sodium nitrite......................... For use only as a rust
preventive in mineral oil
lubricants at a level not to
exceed 3 percent by weight of
the mineral oil.Tetrakis[methylene(3,5-di-tert-butyl-4- For use only as an antioxidant
hydroxyhydro-cinnamate)]methane (CAS in lubricants at a level not
Reg. No. 6683-19-8). to exceed 0.5 percent by
weight of the lubricant.Thiodiethylenebis (3,5-di-tert-butyl-4- For use as an antioxidant at
hydroxyhydrocinnamate) (CAS Reg. No. levels not to exceed 0.5
41484-35-9). percent by weight of the
lubricant.Tri[2(or 4)-C9-10-branched For use only as an extreme
alkylphenyl]phosphorothioate (CAS Reg. pressure-antiwear adjuvant at
No. 126019-82-7). levels not to exceed 0.5
percent by weight of the
lubricant.Triphenyl phosphorothionate (CAS Reg. For use as an adjuvant in
No. 597-82-0). lubricants herein listed at a
level not to exceed 0.5
percent by weight of the
lubricant.Tris(2,4-di-tert-butylphenyl)phosphite For use only as a stabilizer at
(CAS Reg. NO. 31570-04-4). levels not to exceed 0.5
percent by weight of the
lubricant.Thiodiethylenebis(3,5-di-tert-butyl-4- For use as an antioxidant at
hydroxy-hydro- cinnamate) (CAS Reg. levels not to exceed 0.5
No. 41484-35-9). percent by weight of the
lubricant.Zinc sulfide........................... For use at levels not to exceed
10 percent by weight of the
lubricant.------------------------------------------------------------------------
(b) The lubricants are used on food-processing equipment as a protective antirust film, as a release agent on gaskets or seals of tank closures, and as a lubricant for machine parts and equipment in locations in which there is exposure of the lubricated part to food. The amount used is the minimum required to accomplish the desired technical effect on the equipment, and the addition to food of any constituent identified in this section does not exceed the limitations prescribed.
(c) Any substance employed in the production of the lubricants described in this section that is the subject of a regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this chapter conforms with any specification in such regulation. [42 FR 14609, Mar. 15, 1977]
Editorial Note: For Federal Register citations affecting Sec. 178.3570, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.