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178.3570 Lubricants with incidental food contact.

Home > Regulations > Indirect food additives: Adjuvants, production aids, and sanitizers > 178.3570 Lubricants with incidental food contact.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3570]

[Page 414-415]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 178_INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND 
SANITIZERS--Table of Contents
 
             Subpart D_Certain Adjuvants and Production Aids
 
Sec.  178.3570  Lubricants with incidental food contact.

    Lubricants with incidental food contact may be safely used on 
machinery used for producing, manufacturing, packing, processing, 
preparing, treating, packaging, transporting, or holding food, subject 
to the provisions of this section:
    (a) The lubricants are prepared from one or more of the following 
substances:
    (1) Substances generally recognized as safe for use in food.
    (2) Substances used in accordance with the provisions of a prior 
sanction or approval.
    (3) Substances identified in this paragraph (a)(3).

------------------------------------------------------------------------
               Substances                          Limitations
------------------------------------------------------------------------
Aluminum stearoyl benzoyl hydroxide....  For use only as a thickening
                                          agent in mineral oil
                                          lubricants at a level not to
                                          exceed 10 pct by weight of the
                                          mineral oil.
N,N-Bis(2-ethylhexyl)-ar-methyl-1H-      For use as a copper deactivator
 benzotriazole-1-methanamine (CAS Reg.    at a level not to exceed 0.1
 No. 94270-86-7).                         percent by weight of the
                                          lubricant.
BHA....................................
BHT....................................
[alpha]-Butyl-omega-                     Addition to food not to exceed
 hydroxypoly(oxyethylene)                 10 parts per million.
 poly(oxypropylene) produced by random
 condensation of a 1:1 mixture by
 weight of ethylene oxide and propylene
 oxide with butanol; minimum molecular
 weight 1,500; Chemical Abstracts
 Service Registry No. 9038-95-3.
[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.

[[Page 415]]


[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 on GPO Access.

[[Page 416]]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 178, Section 3570


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