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178.3910 Surface lubricants used in the manufacture of metallic articles.

Home > Regulations > Indirect food additives: Adjuvants, production aids, and sanitizers > 178.3910 Surface lubricants used in the manufacture of metallic articles.



[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: 21CFR178.3910]

[Page 444-449]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 178_INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND 
SANITIZERS--Table of Contents
 
             Subpart D_Certain Adjuvants and Production Aids
 
Sec.  178.3910  Surface lubricants used in the manufacture of metallic 
articles.

    The substances listed in this section may be safely used in surface 
lubricants employed in the manufacture of metallic articles that contact 
food, subject to the provisions of this section.
    (a) The following substances may be used in surface lubricants used 
in the rolling of metallic foil or sheet stock provided that total 
residual lubricant remaining on the metallic article in the form in 
which it contacts food does not exceed 0.015 milligram per square inch 
of metallic food-contact surface:
    (1) Substances identified in paragraphs (b)(1) and (2) of this 
section.
    (2) Substances identified in this paragraph.

------------------------------------------------------------------------
           List of substances                      Limitations
------------------------------------------------------------------------
[alpha]-Butyl-[Omega]--hydroxypoly
 (oxyethylene)-poly (oxypropylene) (CAS
 Reg. No. 9038-95-3) produced by random
 condensation of a 1:1 mixture by
 weight of ethylene oxide and propylene
 oxide with butanol and having a
 minimum molecular weight of 1,000.
[alpha]-Butyl-[Omega]-hydroxypoly(oxypr
 opylene) (CAS Reg. No. 9003-13-8)
 having a minimum molecular weight of
 1000.
[alpha]-Lauroyl-[Omega]-hydroxpoly(oxye
 thylene) (CAS Reg. No. 9004-81-3)
 having a minimum molecular weight of
 200.
Acetate esters derived from synthetic
 straight chain alcohols (complying
 with Sec.   172.864 of this chapter)
 that have even numbers of carbon atoms
 in the range C8-C18.
alpha-Alkyl-omega-
 hydroxypoly(oxyethylene) produced by
 the condensation of 1 mole of C12-C15
 straight chain primary alcohols with
 an average of 3 moles of ethylene
 oxide (CAS Reg. No. 68002-97-1).
Benzotriazole (CAS Reg. No. 95-14-7)...
Bis(hydrogenated tallow alkyl)amine      Not to be used in combination
 (CAS Reg. No. 61789-79-5).               with sodium nitrite.
Bis(hydrogenated tallow
 alkyl)aminoethanol (CAS Reg. No.
 116438-56-3).
N,N-Bis(2-hydroxyethyl)butylamine (CAS
 Reg. No. 102-79-4).
Tert-Butyl alcohol.....................
Di(2-ethylhexyl)phthalate..............
Diethyl phthalate......................
Diethylene glycol monobutylether (CAS
 Reg. No. 112-34-5).
Dimers, trimers, and/or their partial    For use only at a level not to
 methyl esters; such dimers and trimers   exceed 10 percent by weight of
 are of unsaturated C18 fatty acids       finished lubricant
 derived from animal and vegetable fats   formulation.
 and oils and/or tall oil, and such
 partial methyl esters meet the
 following specifications:
 Saponification value 180-200, acid
 value 70-130, and maximum iodine value
 120.
Di-n-octyl sebacate....................
Ethylenediaminetetraacetic acid, sodium
 salts.
Isopropyl alcohol......................
Isopropyl laurate (CAS Reg. No. 10233-   For use at a level not to
 13-3).                                   exceed 10 percent by weight of
                                          the finished lubricant
                                          formulation.
Isopropyl oleate.......................
Isotridecyl alcohol, ethoxylated (CAS
 Reg. No. 9043-30-5).
Methyl esters of coconut oil fatty
 acids.
Methyl esters of fatty acids (C16-C18)
 derived from animal and vegetable fats
 and oils.
Polybutene, hydrogenated: complying
 with the identity prescribed under
 Sec.   178.3740(b).
Polyethylene glycol (400) monostearate.
Polyisobutylene (minimum molecular
 weight 300).

[[Page 445]]


Polyoxyethylated (5 moles) tallow amine
 (CAS Reg. No. 61791-26-2).
Polyvinyl alcohol......................
Sodium nitrite.........................  For use only as a rust
                                          inhibitor in lubricant
                                          formulations provided the
                                          total residual sodium nitrite
                                          on the metallic article in the
                                          form in which it contacts food
                                          does not exceed 0.007
                                          milligram per square inch of
                                          metallic food-contact surface.
Sodium petroleum sulfonate, MW 440-450
 (CAS Reg. No. 68608-26-4) derived from
 naphthenic oil having a Saybolt
 viscosity range of 500-600 Saybolt
 Universal Seconds (SUS at 37-8 [deg]C
 (100 [deg]F) as determined by ASTM
 method D88-81, ``Standard Test Method
 for Saybolt Viscosity,'' which is
 incorporated by reference. Copies are
 available from the American Society
 for Testing Materials, 1961 Race St.,
 Philadelphia, PA 19103, or available
 for inspection at the National
 Archives and Records Administration
 (NARA). For information on the
 availability of this material at NARA,
 call 202-741-6030, or go to: http://
 www.archives.gov/federal--register/
 code--of--federal--regulations/ibr--
 locations.html..
Synthetic alcohol mixture of straight-
 and branched-chain alcohols that have
 even numbers of carbon atoms in the
 range C4C18 and that are prepared from
 ethylene, aluminum, and hydrogen such
 that the finished synthetic alcohol
 mixture contains not less than 75 pct
 of straight-chain primary alcohols and
 contains not less than 85 pct total
 C10 and C12 alcohols.
Synthetic primary alcohol mixture of     For use at a level not to
 straight- and branched-chain alcohols    exceed 8 pct by weight of the
 that contain at least 99 pct primary     finished lubricant
 alcohols consisting of the following:    formulation.
 not less than 70 pct normal alcohols;
 not less than 96.5 pct C12-C15
 alcohols; and not more than 2.5 pct
 alpha, omega C13-C16 diols. The
 alcohols are prepared from linear
 olefins from a purified kerosene
 fraction, carbon monoxide and hydrogen
 using a modified oxo process, such
 that the finished primary alcohol
 mixture meets the following
 specifications: Molecular weight,
 2074; hydroxyl number, 266-
 276.
Synthetic primary alcohol mixture of     For use only at a level not to
 straight- and branched-chain alcohols    exceed 8 pct by weight of the
 that contain at least 99 pct primary     finished lubricant
 alcohols consisting of the following:    formulation.
 not less than 70 percent normal
 alcohols; not less than 93 pct C12-C13
 alcohols; not more than 5 pct C14-C15
 alcohols; and not more than 2.5 pct
 alpha, omega, C13-C16 diols. The
 alcohols are prepared from linear
 olefins from a purified kerosene
 fraction, carbon monoxide and hydrogen
 using a modified oxo process, such
 that the finished primary alcohol
 mixture meets the following
 specifications:
  Molecular weight 1945; hydroxyl number, 283-296.
Tallow, sulfonated.....................
Triethanolamine........................
------------------------------------------------------------------------

    (3) Mineral oil conforming to the identity prescribed in Sec.  
178.3620(c).
    (4) Light petroleum hydrocarbons identified in paragraph (a)(4) (i) 
of this section: Provided, That the total residual lubricant on the 
metallic article in the form in which it contacts food meets the 
ultraviolet absorbance limits prescribed in paragraph (a) (4) (ii) of 
this section as determined by the analytical method described in 
paragraph (a) (4) (iii) of this section.
    (i) Light petroleum hydrocarbons are derived by distillation from 
virgin petroleum stocks or are synthesized from petroleum gases. They 
are chiefly paraffinic, isoparaffinic, napthenic, or aromatic in nature, 
and meet the following specifications:
    (a) Initial boiling point is 24 [deg]C minimum and final boiling 
point is 288 [deg]C maximum, as determined by ASTM method D86-82, 
``Standard Method for Distillation of Petroleum Products,'' which is 
incorporated by reference. Copies may be obtained from the American 
Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, 
Philadelphia, PA 19428-2959, or may be examined at the National Archives 
and Records Administration (NARA). For information on the availability 
of this

[[Page 446]]

material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
    (b) Nonvolatile residue is 0.005 gram per 100 milliliters, maximum, 
as determined by ASTM method D381-80, ``Standard Test Method for 
Existent Gum in Fuels by Jet Evaporation,'' when the final boiling point 
is 121 [deg]C or above and by ASTM method D1353-78, ``Standard Test 
Method for Nonvolatile Matter in Volatile Solvents for Use in Paint, 
Varnish, Lacquer, and Related Products,'' when the final boiling point 
is below 121 [deg]C. These ASTM methods are incorporated by reference. 
The availability of these incorporations by reference is given in 
paragraph (a)(4)(i)(a) of this section.
    (c) Saybolt color 20 minimum as determined by ASTM method D156-82, 
``Standard Test Method for Saybolt Color of Petroleum Products (Saybolt 
Chromometer Method),'' which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(a)(4)(i)(a) of this section.
    (d) Aromatic component content shall not exceed 32 percent.
    (e) Conforms with ultraviolet absorbance limits prescribed in Sec.  
178.3620(c) as determined by the analytical method described therein.
    (ii) Ultraviolet absorbance limits on residual lubricants are as 
follows:

------------------------------------------------------------------------
                                                               Maximum
                                                              absorbance
                                                                per 5
                   Wavelength (m[micro])                     centimeters
                                                               optical
                                                              pathlength
------------------------------------------------------------------------
280-289....................................................          0.7
290-299....................................................           .6
300-359....................................................           .4
360-400....................................................          .09
------------------------------------------------------------------------

    (iii) The analytical method for determining ultraviolet absorbance 
limits on residual lubricants is as follows:

                          general instructions

    Because of the sensitivity of the test, the possibility of errors 
arising from contamination is great. It is of the greatest importance 
that all glassware be scrupulously cleaned to remove all organic matter 
such as oil, grease, detergent, residues, etc. Examine all glassware 
including stoppers and stopcocks, under ultraviolet light to detect any 
residual fluorescent contamination. As a precautionary measure it is 
recommended practice to rinse all glassware with purified isooctane 
immediately before use. No grease is to be used on stopcocks or joints. 
Great care to avoid contamination of oil samples in handling and to 
assure absence of any extraneous material arising from inadequate 
packaging is essential. Because some of the polynuclear hydrocarbons 
sought in this test are very susceptible to photo-oxidation, the entire 
procedure is to be carried out under subdued light.

                                apparatus

    Separatory funnels. 250-milliliter, 500-milliliter, 1,000-
milliliter, and preferably 2,000-milliliter capacity, equipped with 
tetrafluoroethylene polymer stopcocks.
    Evaporation flask (optional). 250-milliliter or 500-milliliter 
capacity all-glass flask equipped with standard-taper stopper having 
inlet and outlet tubes to permit passage of nitrogen across the surface 
of contained liquid to be evaporated.
    Spectrophotometric cells. Fused quartz cells, optical path length in 
the range of 5,000 centimeters 0.005 centimeter; 
also for checking spectrophotometer performance only, optical path 
length in the range 1.000 centimeter 0.005 
centimeter. With distilled water in the cells, determine any absorbance 
differences.
    Spectrophotometer. Special range 250 millicrons-400 millimicrons 
with spectral slit width of 2 millimicrons or less; under instrument 
operating conditions for these absorbance measurements, the 
spectrophotometer shall also meet the following performance 
requirements:
    Absorbance repeatability, 0.01 at 0.4 
absorbance.
    Absorbance accuracy, \1\ 0.05 at 0.4 
absorbance.
---------------------------------------------------------------------------

    \1\ As determined by procedure using potassium chromate for 
reference standard and described in National Bureau of Standards 
Circular 484, Spectrometry, U.S. Department of Commerce (1949), which is 
incorporated by reference. Copies are available from the Center for Food 
Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal--register/code--of--
federal--regulations/ibr--locations.html. The accuracy is to be 
determined by comparison with the standard values at 210, 345, and 400 
millimicrons.
---------------------------------------------------------------------------

    Wavelength repeatability, 0.2 millimicron.
    Wavelength accuracy, 1.0 millimicron.

[[Page 447]]

    Soxhlet apparatus. 60-millimeter diameter body tubes fitted with 
condenser and 500-milliliter round-bottom boiling flask. A supply of 
paper thimbles to fit is required.
    Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in 
cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.

                         reagents and materials

    Organic solvents. All solvents used throughout the procedure shall 
meet the specifications and tests described in this specification. The 
isooctane (2,2,4-trimethylpentane) shall pass the following test:
    Place 180 milliliters of solvent in a 250-milliliter Erlenmeyer 
flask, add 1 milliliter of purified n-hexadecane and evaporate on the 
steam bath under a stream of nitrogen (a loose aluminum foil jacket 
around the flask will speed evaporation). Discontinue evaporation when 
not over 1 milliliter of residue remains.
    Alternatively, the evaporation time can be reduced by using the 
optional evaporation flask. In this case the solvent and n-hexadecane 
are placed in the flask on the steam bath, the tube assembly is 
inserted, and a stream of nitrogen is fed through the inlet tube while 
the outlet tube is connected to a solvent trap and vacuum line in such a 
way as to prevent any flow-back of condensate into the flask.
    Dissolve the 1 milliliter of hexadecane residue in isooctane and 
make to 25 milliliters volume. Determine the absorbance in the 5-
centimeter path length cells compared to isooctane as reference. The 
absorbance of the solution of the solvent residue shall not exceed 0.01 
per centimeter path length between 280 and 400 m[micro]. Purify, if 
necessary, by passage through a column of activated silica gel (Grade 
12, Davison Chemical Co., Baltimore, Maryland, or equivalent) about 90 
centimeters in length and 5 centimeters to 8 centimeters in diameter.
    n-Hexadecane, 99-percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 25 milliliters with isooctane and determine the absorbance 
in a 5-centimeter cell compared to isooctane as reference point between 
280 m[micro]-400 m[micro]. The absorbance per centimeter path length 
shall not exceed 0.00 in this range. Purify, if necessary, by 
percolation through activated silica gel or by distillation.
    Dimethyl sulfoxide. Spectrophotometric grade (Crown Zellerbach 
Corp., Camas, Washington, or equivalent). Absorbance (1-centimeter cell, 
distilled water reference, sample completely saturated with nitrogen).

------------------------------------------------------------------------
                                                              Absorbance
                         Wavelength                            (maximum)
------------------------------------------------------------------------
261.5.......................................................        1.00
270.........................................................         .20
275.........................................................         .09
280.........................................................         .06
300.........................................................        .015
------------------------------------------------------------------------

    There shall be no irregularities in the absorbance curve within 
these wavelengths.
    Phosphoric acid. 85 percent A.C.S. reagent grade.
    Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in 
granular form. For each bottle of sodium sulfate reagent used, establish 
as follows the necessary sodium sulfate prewash to provide such filters 
required in the method: Place approximately 35 grams of anhydrous sodium 
sulfate in a 30-milliliter coarse, fritted-glass funnel or in a 65-
milliliter filter funnel with glass wool plug; wash with successive 15-
milliliter portions of the indicated solvent until a 15-milliliter 
portion of the wash shows 0.00 absorbance per centimeter path length 
between 280 m[micro] and 400 m[micro] when tested as prescribed under 
``Organic solvents.'' Usually three portions of wash solvent are 
sufficient.
    Before proceeding with analysis of a sample, determine the 
absorbance in a 5-centimeter path cell between 250 millimicrons and 400 
millimicrons for the reagent blank by carrying out the procedure, 
without a metal sample. The absorbance per centimeter path length should 
not exceed 0.02 in the wavelength range from 280 m[micro] to 400 
m[micro].
    Place 300 milliliters of dimethyl sulfoxide in a 1-liter separatory 
funnel and add 75 milliliters of phosphoric acid. Mix the contents of 
the funnel and allow to stand for 10 minutes. (The reaction between the 
sulfoxide and the acid is exothermic. Release pressure after mixing, 
then keep funnel stoppered.) Add 150 milliliters of isooctane and shake 
to pre-equilibrate the solvents. Draw off the individual layers and 
store in glass-stoppered flasks.

                                procedure

    Sample. Select metal foil or sheet stock for the test which has not 
been previously contaminated by careless handling or exposure to 
atmospheric dust and fumes. A commercial coil in the form supplied for 
spindle mounting in a packaging line or wrapping machine is most 
suitable. Strip off the outside turn of metal and discard. Carefully 
avoid contamination or damage from handling the metal (wear gloves). 
Remove a 16-18-foot length from the coil and place it on a flat surface 
protected by a length of new kraft paper. Cut four 15-foot strips from 
the sample, each 3 inches wide (avoid tearing the edges of the strips). 
Using a piece of suitable glass rod, roll the strips of metal into loose 
coils and insert each into a Soxhlet thimble. Each turn of coil should 
be visibly separated from the adjacent turn.

[[Page 448]]

    Extraction. Fill each of the four Soxhlet tubes with purified 
isooctane (see under heading ``Reagents and Materials,'' above) until 
siphon action occurs and then refill the tube body. Supply heat to the 
boiling flask and allow extraction to continue for at least 8 hours or 
until repeated weighings of the dried and cooled coil show no further 
weight loss.
    Combine the isooctane extracts from the four Soxhlet units in a 
suitable beaker, rinsing each tube and flask into the beaker with fresh 
purified solvent. Evaporate the solvent under an atmosphere of inert gas 
(nitrogen) to residual volume of 50-60 milliliters and transfer this 
solution to a 500-milliliter separatory funnel containing 100 
milliliters of pre-equilibrated sulfoxide-phosphoric acid mixture. 
Complete the transfer of the sample with small portions of pre-
equilibrated isooctane to give a total volume of the residue and solvent 
of 75 milliliters. Shake the funnel vigorously for 2 minutes. Set up 
three 250-milliliter separatory funnels with each containing 30 
milliliters of pre-equilibrated isooctane. After separation of liquid 
phases, carefully draw off lower layer into the first 250-milliliter 
separatory funnel and wash in tandem with the 30-milliliter portion of 
isooctane contained in the 250-milliliter separatory funnels. Shaking 
time for each wash is 1 minute. Repeat the extraction operation with two 
additional portions of the sulfoxide-acid mixture and wash each 
extractive in tandem through the same three portions of isooctane.
    Collect the successive extractives (300 milliliters total) in a 
separatory funnel (preferably 2-liter) containing 480 milliliters of 
distilled water; mix, and allow to cool for a few minutes after the last 
extractive has been added. Add 80 milliliters of isooctane to the 
solution and extract by shaking the funnel vigorously for 2 minutes. 
Draw off the lower aqueous layer into a second separatory funnel 
(preferably 2-liter) and repeat the extraction with 80 milliliter of 
isooctane. Draw off and discard the aqueous layer. Wash each of the 80 
milliliter extractives three times with 100-milliliter portions 
distilled water. Shaking time for each wash is 1 minute. Discard the 
aqueous layers. Filter the first extractive through anhydrous sodium 
sulfate pre-washed with isooctane (see sodium sulfate under ``Reagents 
and Materials'' for preparation of filter) into a 250-milliliter 
Erlenmeyer flask (or optionally into the evaporation flask). Wash the 
first separatory funnel with the second 80-milliliter isooctane 
extractive and pass through the sodium sulfate. Then wash the second and 
first separatory funnels successively with a 20-milliliter portion of 
isooctane and pass the solvent through the sodium sulfate into the 
flask. Add 1 milliliter of n-hexadecane and evaporate the isooctane on 
the steam bath under nitrogen. Discontinue evaporation when not over 1 
milliliter of residue remains. To the residue, add a 10-milliliter 
portion of isooctane, reevaporate to 1 milliliter of hexadecane, and 
repeat this operation once.
    Quantitatively transfer the residue with isooctane to a 25-
milliliter volumetric flask, make to volume, and mix. Determine the 
absorbance of the solution in 5-centimeter pathlength cells compared to 
isooctane as reference between 280m[micro]-400m[micro] (take care to 
lose none of the solution in filling the sample cell). Correct the 
absorbance values for any absorbance derived from reagents as determined 
by carrying out the procedure without a metal sample. If the corrected 
absorbance does not exceed the limits prescribed in this paragraph, the 
residue meets the ultraviolet absorbance specifications.

    (b) The following substances may be used in surface lubricants used 
to facilitate the drawing, stamping, or forming of metallic articles 
from rolled foil or sheet stock by further processing provided that the 
total residual lubricant remaining on the metallic article in the form 
in which it contacts food does not exceed 0.2 milligram per square inch 
of food-contact surface:
    (1) Antioxidants used in compliance with regulations in parts 170 
through 189 of this chapter.
    (2) Substances identified in this subparagraph.

------------------------------------------------------------------------
           List of substances                      Limitations
------------------------------------------------------------------------
Acetyl tributyl citrate................
Acetyl triethyl citrate................
Butyl stearate.........................
Castor oil.............................
Dibutyl sebacate.......................
Di(2-ethylhexyl) azelate...............
Di(2-ethylhexyl) sebacate..............
Diisodecyl phthalate...................
Dimethylpolysiloxane...................  Conforming to the identity
                                          prescribed in Sec.   181.28 of
                                          this chapter.
Dipropylene glycol.....................
Epoxidized soybean oil.................  Conforming to the identity
                                          prescribed in Sec.   181.27 of
                                          this chapter.

[[Page 449]]


Fatty acids derived from animal and
 vegetable fats and oils, and salts of
 such acids, single or mixed, as
 follows:
  Aluminum
  Magnesium
  Potassium
  Sodium
  Zinc
Fatty alcohols, straight-chain with
 even number carbon atoms (C10 or
 greater).
Isobutyl stearate......................
Lanolin................................
Linoleic acid amide....................
Mineral oil............................  Conforming to the identity
                                          prescribed in Sec.   178.3620
                                          (a) or (b).
Mono-, di-, and tristearyl citrate.....
Oleic acid amide.......................
Palmitic acid amide....................
Petrolatum.............................  Conforming to the identity
                                          prescribed in Sec.   178.3700.
Phosphoric acid, mono- and dihexyl       For use only at levels not to
 esters, compounds with                   exceed 0.5 percent by weight
 tetramethylnonylamines and C11-14-       of the finished surface
 alkylamines (CAS Reg. No. 80939-62-4).   lubricant formulation.
Polyethylene glycol (molecular weight    Mono- and diethylene glycol
 300 or greater).                         content not to exceed a total
                                          of 0.2 pct.
Stannous stearate......................
Stearic acid amide.....................
Stearyl stearate.......................
Tetrakis[methylene (3,5-di-tert-butyl-4- For use at a level not to
 hydroxyhydrocinnamate)] methane (CAS     exceed 0.5 percent by weight
 Registry No. 6683-19-8).                 of the finished surface
                                          lubricant formulation.
Triethylene glycol.....................  Diethylene glycol content not
                                          to exceed 0.1 pct.
Wax, petroleum.........................  Complying with Sec.   178.3710.
------------------------------------------------------------------------

    (c) The substances identified in paragraph (a)(2) of this section 
may be used in surface lubricants used to facilitate the drawing, 
stamping, and forming of metallic articles from rolled foil and sheet 
stock provided that total residual lubricant remaining on the metallic 
article in the form in which it contacts food does not exceed 0.015 
milligram per square inch of food-contact surface.
    (d) Subject to any prescribed limitations, the quantity of surface 
lubricant used in the manufacture of metallic articles shall not exceed 
the least amount reasonably required to accomplish the intended 
technical effect and shall not be intended to nor, in fact, accomplish 
any technical effect in the food itself.
    (e) The use of the surface lubricants in the manufacture of any 
article that is the subject of a regulation in parts 174, 175, 176, 177, 
178 and Sec.  179.45 of this chapter must comply with any specifications 
prescribed by such regulation for the finished form of the article.
    (f) Any substance that is listed in this section and the subject of 
a regulation in parts 174, 175, 176, 177, 178 and Sec.  179.45 of this 
chapter shall comply with any applicable specifications prescribed by 
such regulation.

[42 FR 14609, Mar. 15, 1977, as amended at 48 FR 238, Jan. 4, 1983; 49 
FR 10113, Mar. 19, 1984; 49 FR 29579, July 23, 1984; 50 FR 36874, Sept. 
10, 1985; 52 FR 10223, Mar. 31, 1987; 54 FR 6124, Feb. 8, 1989; 54 FR 
24899, June 12, 1989; 56 FR 55456, Oct. 28, 1991; 57 FR 23953, June 5, 
1992; 58 FR 17513, Apr. 5, 1993; 64 FR 47110, Aug. 30, 1999; 69 FR 
24512, May 4, 2004]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 178, Section 3910


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