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178.3770 Polyhydric alcohol esters of oxidatively refined (Gersthofen process) montan wax acids.

Home > Regulations > Indirect food additives: Adjuvants, production aids, and sanitizers > 178.3770 Polyhydric alcohol esters of oxidatively refined (Gersthofen process) montan wax acids.



[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: 21CFR178.3770]

[Page 432-437]
 
                        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.  178.3770  Polyhydric alcohol esters of oxidatively refined 
(Gersthofen process) montan wax acids.

    Polyhydric alcohol esters of oxidatively refined (Gersthofen 
process) montan wax acids identified in this section may be safely used 
as components of articles intended for use in contact with food in 
accordance with the following prescribed conditions:
    (a) The polyhydric alcohol esters identified in this paragraph may 
be used as lubricants in the fabrication of vinyl chloride plastic food-
contact articles prepared from polyvinyl chloride and/or from vinyl 
chloride copolymers complying with Sec.  177.1980 of this chapter. Such 
esters meet the following specifications and are produced by partial 
esterification of oxidatively refined (Gersthofen process) montan wax 
acids by either ethylene glycol or 1,3-butanediol with or without 
neutralization of unreacted carboxylic groups with calcium hydroxide:
    (1) Dropping point 76[deg]-105 [deg]C, as determined by ASTM method 
D566-76 (Reapproved 1982), ``Standard Test Method for Dropping Point of 
Lubricating Grease,'' 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 material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal--register/code--of--
federal--regulations/ibr--locations.html.
    (2) Acid value 10-20, as determined by ASTM method D1386-78 
(``Standard Test Method for Acid Number (Empirical) of Synthetic and 
Natural Waxes'' (Revised 1978), which is incorporated by reference; 
copies are available from American Society for Testing and Materials 
(ASTM), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-
2959, 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.) 
using as solvent xylene-ethyl alcohol in a 2:1 ratio instead of toluene-
ethyl alcohol in a 2:1 ratio.
    (3) Saponification value 100-160, as determined by ASTM method 
D1387-78 (``Standard Test Method for Saponification Number (Empirical) 
of Synthetic and Natural Waxes'' (Revised 1978), which is incorporated 
by reference; copies are available from American Society for Testing and 
Materials (ASTM), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, 
PA 19428-2959, 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.) using xylene-ethyl alcohol in a 2:1 ratio instead of 
ethyl alcohol in preparation of potassium hydroxide solution.
    (4) Ultraviolet absorbance limits as follows, as determined by the 
analytical method described in this subparagraph:
    Ultraviolet absorbance per centimeter pathlength.

------------------------------------------------------------------------
                        Millimicrons                            Maximum
------------------------------------------------------------------------
280 to 289..................................................        0.07
290 to 299..................................................         .06
300 to 359..................................................         .04
360 to 400..................................................         .01
------------------------------------------------------------------------

                            Analytical Method

                          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 wax 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

[[Page 433]]

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.
    Reservoir. 1,000-milliliter capacity, equipped with a 24/40 standard 
taper male fitting at the bottom and a suitable balljoint at the top.
    Chromatographic tube. 1,200 millimeters in length, inside diameter 
to be 16.5 millimeters 0.5 millimeter, equipped 
with a coarse, fritted-glass disc, a tetrafluoroethylene polymer 
stopcock, and a female 24/40 standard tapered fitting at the opposite 
end. (Overall length of the column with the female joint is 1,255 
millimeters.) The female fitting should be equipped with glass hooks.
    Disc. Tetrafluoroethylene polymer 2-inch diameter disc approximately 
\3/16\-inch thick with a hole bored in the center to closely fit the 
stem of the chromatographic tube.
    Heating jackets. Conical, for 500-milliliter and 1,000-milliliter 
separatory funnels. (Used with variable transformer heat control.)
    Suction flask. 250-milliliter or 500-milliliter filter flask.
    Condenser. \24/40\ joints, fitted with a drying tube, length 
optional.
    Evaporation flasks (optional). A 250-milliliter or 500-milliliter 
capacity and a 1-liter 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.
    Vacuum distillation assembly. All glass (for purification of 
dimethyl sulfoxide) 2-liter distillation flask with heating mantle; 
Vigreaux vacuum-jacketed condenser (or equivalent) about 45 centimeters 
in length and distilling head with separable cold finger condenser. Use 
of tetrafluoroethylene polymer sleeves on the glass joints will prevent 
freezing. Do not use grease on stopcocks or joints.
    Oil bath. Capable of heating to 90 [deg]C.
    Spectrophotometric cells. Fused quartz cells, optical pathlength in 
the range 1.000 centimeter 0.005 centimeter. With 
distilled water in the cells, determine any absorbance differences.
    Spectrophotometer. Spectral range 250 millimicrons-400 millimicrons 
with spectral slit width of 0.2 millimicron 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). The 
accuracy is to be determined by comparison with the standard values at 
290, 345, and 400 millimicrons. Circular 484 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.
---------------------------------------------------------------------------

    Wavelength repeatability, 0.2 millimicron.
    Wavelength accuracy, 1.0 millimicron.
    Recording time, 50 seconds.
    Time constant, 0.6 second.
    Sensitivity, 30.
    Ordinate scale, 90-100 percent transmission through scale.
    Abscissa scale, 8X.
    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 and benzene designated in the list following this paragraph 
shall pass the following test:
    To be specified quantity 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. (To the residue from benzene 
add a 10-milliliter portion of purified isooctane, reevaporate, and 
repeat once to insure complete removal of benzene.)
    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.

[[Page 434]]

    Dissolve the 1 milliliter of hexadecane residue in isooctane and 
make up to 25 milliliters volume. Determine the absorbance in the 1-
centimeter pathlength cells compared to isooctane as reference. The 
absorbance of the solution of the solvent residue (except for methyl 
alcohol) shall not exceed 0.01 per centimeter pathlength between 280 
m[micro] and 400 m[micro].
    Isooctane (2,2,4-trimethylpentane). Use 180 milliliters for the test 
described in the preceding paragraph. Purify, if necessary, by passage 
through a column of activated silica gel (Grade 12, Davison Chemical 
Co., Baltimore, Md., or equivalent) about 90 centimeters in length and 5 
centimeters to 8 centimeters in diameter.
    Benzene, A.C.S. reagent grade. Use 150 milliliters for the test. 
Purify, if necessary, by distillation or otherwise.
    n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 25 milliliters with isooctane and determine the absorbance 
in a 1-centimeter cell compared to isooctane as reference point between 
280 m[micro]-400 m[micro]. The absorbance per centimeter pathlength 
shall not exceed 0.00 in this range. If necessary, purify by filtering 
through a column containing 100 grams of aluminum oxide (use same grade 
as described below) in the lower half and 100 grams of activated silica 
gel in the upper half keeping the column at 150 [deg]C., for a period of 
15 hours or overnight. The first 100 milliliters of eluate are used. 
Purification can also be accomplished by distillation.
    Dimethyl sulfoxide. Pure grade, clear, water-white, m.p. 18[deg] 
minimum. Dilute 120 milliliters of dimethyl sulfoxide with 240 
milliliters of distilled water in a 500-milliliter separatory funnel, 
mix and allow to cool for 5-10 minutes. Add 40 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 500-milliliter 
separatory funnel and repeat the extraction with 40 milliliters of 
isooctane. Draw off and discard the aqueous layer. Wash each of the 40-
milliliter extractives three times with 50-milliliter portions of 
distilled water. Shaking time for each wash is 1 minute. Discard the 
aqueous layers. Filter the first extractive through anhydrous sodium 
sulfate prewashed with isooctane (see Sodium sulfate under ``Reagents 
and materials'' for preparation of filter), into a 250-milliliter 
Erlenmeyer flask, or optionally into the evaporating flask. Wash the 
first separatory funnel with the second 40-milliliter isooctane 
extractive, and pass through the sodium sulfate into the flask. Then 
wash the second and first separatory funnels successively with a 10-
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 and reevaporate to 1 milliliter of 
hexadecane. Again, add 10 milliliters of isooctane to the residue and 
evaporate to 1 milliliter of hexadecane to insure complete removal of 
all volatile materials. Dissolve the 1 milliliter of hexadecane in 
isooctane and make to 25-milliliter volume. Determine the absorbance in 
1-centimeter pathlength cells compared to isooctane as reference. The 
absorbance of the solution should not exceed 0.02 per centimeter 
pathlength in the 280 m[micro]-400 m[micro] range. (Note: Difficulty in 
meeting this absorbance specification may be due to organic impurities 
in the distilled water. Repetition of the test omitting the dimethyl 
sulfoxide will disclose their presence. If necessary to meet the 
specification, purify the water by redistillation, passage through an 
ion-exchange resin, or otherwise.)
    Purify, if necessary, by the following procedure: To 1,500 
milliliters of dimethyl sulfoxide in a 2-liter glass-stoppered flask, 
add 6.0 milliliters of phosphoric acid and 50 grams of Norit A 
(decolorizing carbon, alkaline) or equivalent. Stopper the flask, and 
with the use of a magnetic stirrer (tetrafluoroethylene polymer coated 
bar) stir the solvent for 15 minutes. Filter the dimethyl sulfoxide 
through four thicknesses of fluted paper (18.5 centimeters, Schleicher & 
Schuell, No. 597, or equivalent). If the initial filtrate contains 
carbon fines, refilter through the same filter until a clear filtrate is 
obtained. Protect the sulfoxide from air and moisture during this 
operation by covering the solvent in the funnel and collection flask 
with a layer of isooctane. Transfer the filtrate to a 2-liter separatory 
funnel and draw off the dimethyl sulfoxide into the 2-liter distillation 
flask of the vacuum distillation assembly and distill at approximately 
3-millimeter Hg pressure or less. Discard the first 200-milliliter 
fraction of the distillate and replace the distillate collection flask 
with a clean one. Continue the distillation until approximately 1 liter 
of the sulfoxide has been collected.
    At completion of the distillation, the reagent should be stored in 
glass-stoppered bottles since it is very hygroscopic and will react with 
some metal containers in the presence of air.
    Phosphoric acid. 85 percent A.C.S. reagent grade.
    Aluminum oxide (80-200 mesh Woelm neutral activity grade 1 
[Brockmann], Alupharm Chemicals, New Orleans, La., or equivalent). 
Pipette 1 milliliter of distilled water into a dry 250-milliliter 
Erlenmeyer flask equipped with a ground-glass stopper. Stopper the flask 
and rotate it in such a manner as to completely wet out the inside 
surfaces. When this has been done add 180 grams of the aluminum oxide 
and shake until no lumps or wet spots

[[Page 435]]

remain. Allow to stand at room temperature for a period of 2 hours. At 
the end of this time the water should be evenly distributed throughout 
the aluminum oxide powder, and it should have the same free flowing 
properties as the original material (flow velocity with water 0.2 
milliliter per minute). At this point the aluminum oxide has an activity 
of 1 as expressed in Brockmann degrees, and the amount of added water is 
0.5 percent by volume. This product is used in toto and as is, without 
further screening.
    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-
millimeter 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 pathlength 
between 280 m[micro] and 400 m[micro] when tested as prescribed under 
``Organic solvents.'' Usually three portions of wash solvent are 
sufficient.

                                procedure

    Before proceeding with analysis of a sample, determine the 
absorbance in a 1-centimeter path cell between 250 m[micro] and 400 
m[micro] for the reagent blank by carrying out the procedure, without a 
wax sample, at room temperature, recording the spectrum after the 
complete procedure as prescribed. The absorbance per centimeter 
pathlength following the complete procedure should not exceed 0.04 in 
the wavelength range from 280 m[micro] to 299 m[micro], inclusive, nor 
0.02 in the wavelength range from 300 m[micro] to 400 m[micro]. If in 
either spectrum the characteristic benzene peaks in the 250 m[micro]-260 
m[micro] region are present, remove the benzene by the procedure under 
``Organic solvents'' and record absorbance again. 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 preequilibrate 
the solvents. Draw off the individual layers and store in glass-
stoppered flasks.
    In a 1-liter separatory funnel place a representative 25-gram sample 
of wax, add 50 milliliters of isooctane, heat gently, stir until the wax 
is in solution; add 100 milliliters of preequilibrated sulfoxide-
phosphoric acid mixture and shake, making sure it remains in solution. 
If the wax comes out of solution during these operations, let the 
stoppered funnel remain in the jacket until the wax redissolves. (Remove 
stopper from the funnel at intervals to release pressure.) When the wax 
is in solution, remove the funnel from the jacket and shake it 
vigorously for 2 minutes. Set up three 250-milliliter separatory funnels 
with each containing 30 milliliters of preequilibrated isooctane. After 
separation of the liquid phases, allow to cool until the main portion of 
the wax-isooctane solution begins to show a precipitate. Gently swirl 
the funnel when precipitation first occurs on the inside surface of the 
funnel to accelerate this process. Carefully draw off the lower layer, 
filter it slowly through a thin layer of glass wool fitted loosely in a 
filter funnel into the first 250-milliliter separatory funnel, and wash 
in tandem with the 30-milliliter portions 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, replacing the funnel in the jacket after 
each extraction to keep the wax in solution and washing 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 milliliters of 
isooctane. Draw off and discard the aqueous layer. Wash each of the 80-
milliliter extractives three times with 100-milliliter portions of 
distilled water. Shaking time for each wash is 1 minute. Discard the 
aqueous layers. Filter the first extractive through anhydrous sodium 
sulfate prewashed 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 
using an aspirator vacuum under nitrogen and in an oil bath temperature 
of approximately 90 [deg]C. 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.
    Reserve the residue for column chromatography on the aluminum oxide. 
Fit the tetrafluoroethylene polymer disc on the upper part of the stem 
of the

[[Page 436]]

chromatographic tube, then place the tube with the disc on the suction 
flask and apply the vacuum (approximately 135 millimeters Hg pressure). 
Weigh out 180 grams of the aluminum oxide and pour the adsorbent mixture 
into the chromatographic tube in approximately 30-centimeter layers. 
After the addition of each layer, level off the top of the adsorbent 
with a flat glass rod or metal plunger by pressing down firmly until the 
adsorbent is well packed. Loosen the topmost few millimeters of each 
adsorbent layer with the end of a metal rod before the addition of the 
next layer. Continue packing in this manner until all the 180 grams of 
the adsorbent is added to the tube. Level off the top of the adsorbent 
by pressing down firmly with a flat glass rod or metal plunger to make 
the depth of the adsorbent bed approximately 80 centimeters in depth. 
Turn off the vacuum and remove the suction flask. Dissolve the 
hexadecane residue in 10 milliliters of warm benzene and decant the 
solution onto the column and allow the liquid level to recede to barely 
above the adsorbent level. Rapidly complete the transfer similarly with 
two 10-milliliter portions of benzene swirling the flask repeatedly each 
time to assure adequate washing of the residue. Fix the 1,000-milliliter 
reservoir onto the top of the chromatographic column. Just before the 
final 10-milliliter wash reaches the top of the adsorbent, add 670 
milliliters of benzene to the reservoir and continue the percolation at 
the 2-3 milliliter per minute rate until a total of 670 milliliters of 
benzene has been utilized. Collect the eluate in a clean 1-liter 
Erlenmeyer flask (or optionally into a 1-liter evaporation flask). Allow 
the column to drain until most of the solvent mixture is removed. Add 1 
milliliter of n-hexadecane and completely remove the benzene by 
evaporation under nitrogen, using the special procedure to eliminate 
benzene as previously described under ``Organic Solvents.'' 
Quantitatively transfer the residue with isooctane to a 25-milliliter 
volumetric flask and adjust to volume. Determine the absorbance of the 
solution in the 1-centimeter pathlength cells compared to isooctane as 
reference between 250 m[micro]-400 m[micro]. Correct for any absorbance 
derived from the reagents as determined by carrying out the procedure 
without a wax sample. If either spectrum shows the characteristic 
benzene peaks in the 250 m[micro]-260 m[micro] region, evaporate the 
solution to remove benzene by the procedure under ``Organic Solvents.'' 
Dissolve the residue, transfer quantitatively, and adjust to volume in 
isooctane in a 25-milliliter volumetric flask. Record the absorbance 
again. If the corrected absorbance does not exceed the limits prescribed 
in paragraph (a) of this section, the wax meets the ultraviolet 
absorbance specifications.

    (b) The polyhydric alcohol esters identified in this paragraph may 
be used as release agents in resinous and polymeric coatings for 
polyolefin films complying with Sec.  175.320 of this chapter. Such 
esters meet the following specifications and are produced by partial 
esterification of oxidatively refined (Gersthofen process) montan wax 
acids with equimolar proportions of ethylene glycol and 1,3-butanediol:
    (1) Dropping point 77[deg]-82 [deg]C, as determined by ASTM method 
D566-76 (Reapproved 1982), ``Standard Test Method for Dropping Point of 
Lubricating Grease,'' which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(a)(1) of this section.
    (2) Acid value 25-35, as determined by ASTM method D1386-78 
(``Standard Test Method for Acid Number (Empirical) of Synthetic and 
Natural Waxes'' (Revised 1978), which is incorporated by reference; 
copies are available from American Society for Testing and Materials 
(ASTM), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-
2959, 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.) 
using as solvent xylene-ethyl alcohol in a 2:1 ratio instead of toluene-
ethyl alcohol in a 1:2 ratio.
    (3) Saponification value 135-150, as determined by ASTM method 
D1387-78 (``Standard Test Method for Saponification Number (Empirical) 
of Synthetic and Natural Waxes'' (Revised 1978), which is incorporated 
by reference; copies are available from American Society for Testing and 
Materials (ASTM), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, 
PA 19428-2959, 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.) using xylene-ethyl alcohol in a 2:1 ratio instead of 
ethyl alcohol in preparation of potassium hydroxide solution.

[[Page 437]]

    (4) Ultraviolet absorbance limits specified in paragraph (a)(4) of 
this section, as determined by the analytical method described therein.
    (c) The polyhydric alcohol esters of oxidatively refined (Gersthofen 
process) montan wax acids, identified in paragraph (a) or (b) of this 
section, may also be used as a component of an aqueous dispersion of 
vinylidene chloride copolymers, subject to the conditions described in 
paragraphs (c) (1) and (2) of this section.
    (1) The aqueous dispersion of the additive contains not more that 18 
percent polyhydric alcohol esters of oxidatively refined (Gersthofen 
process) montan wax acids, not more than 2 percent poly(oxyethylene) 
(minimum 20 moles of ethylene oxide) oleyl ether (CAS Reg. No. 9004-98-
2), and not more than 1 percent poly(oxyethylene) (minimum 3 moles 
ethylene oxide) cetyl alcohols (CAS Reg. No. 9004-95-9).
    (2) The aqueous dispersion described in paragraph (c)(1) of this 
section is used as an additive to aqueous dispersions of vinylidene 
chloride copolymers, regulated in Sec. Sec.  175.300, 175.320, 175.360, 
176.170, 176,180, and 177.1630 of this chapter, at levels not to exceed 
1.5 percent (solids basis) in the finished coating.
    (d) The polyhydric alcohol esters identified in this paragraph may 
be used as lubricants in the fabrication of vinyl chloride plastic food 
contact articles prepared from vinyl chloride polymers. Such esters meet 
the following specifications and are produced by partial esterification 
of oxidatively refined (Gersthofen process) montan wax acids with 
glycerol followed by neutralization:
    (1) Dropping point 79 to 85 [deg]C, as determined by the American 
Society for Testing and Materials (ASTM), Method D-566-76 (Reapproved 
1982), ``Standard Test Method for Dropping Point of Lubricating 
Grease,'' which is incorporated by reference in accordance with 5 U.S.C. 
552(a). The availability of this incorporation by reference is given in 
paragraph (a)(1) of this section.
    (2) Acid value 20-30, as determined by ASTM Method D-1386-78 
``Standard Test Method for Acid Number (Empirical) of Synthetic and 
Natural Waxes'' (Revised 1978) (which is incorporated by reference in 
accordance with 5 U.S.C. 552(a); the availability of this incorporation 
by reference is given in paragraph (a)(2) of this section), using as a 
solvent xylene-ethyl alcohol in a 2:1 ratio instead of toluene-ethyl 
alcohol in a 2:1 ratio.
    (3) Saponification value 130-160, as determined by ASTM Method D-
1387-78 ``Standard Test Method for Saponification Number (Empirical) of 
Synthetic and Natural Waxes'' (Revised 1978), (which is incorporated by 
reference in accordance with 5 U.S.C. 552(a); the availability of this 
incorporation by reference is given in paragraph (a)(3) of this 
section), using xylene-ethyl alcohol in a 2:1 ratio instead of ethyl 
alcohol in the preparation of potassium hydroxide solution.
    (4) Ultraviolet absorbance limits specified in paragraph (a)(4) of 
this section, as determined by the analytical method described therein.

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11848, Mar. 19, 1982; 
49 FR 10113, Mar. 19, 1984; 51 FR 33895, Sept. 24, 1986; 54 FR 24898, 
June 12, 1989; 55 FR 28020, July 9, 1990; 58 FR 17512, Apr. 5, 1993; 69 
FR 24512, May 4, 2004]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 178, Section 3770


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