[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: 21CFR172.820]
[Page 83-84]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 172_FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN
CONSUMPTION--Table of Contents
Subpart I_Multipurpose Additives
Sec. 172.820 Polyethylene glycol (mean molecular weight 200-9,500).
Polyethylene glycol identified in this section may be safely used in
food in accordance with the following prescribed conditions:
(a) Identity. (1) The additive is an addition polymer of ethylene
oxide and water with a mean molecular weight of 200 to 9,500.
(2) It contains no more than 0.2 percent total by weight of ethylene
and diethylene glycols when tested by the analytical methods prescribed
in paragraph (b) of this section.
(b) Analytical method. (1) The analytical method prescribed in the
National Formulary XV (1980), page 1244, for polyethylene glycol 400
shall be used to determine the total ethylene and diethylene glycol
content of polyethylene glycols having mean molecular weights of 450 or
higher.
(2) The following analytical method shall be used to determine the
total ethylene and diethylene glycol content of polyethylene glycols
having mean molecular weights below 450.
Analytical Method
ethylene glycol and diethylene glycol content of polyethylene glycols
The analytical method for determining ethylene glycol and diethylene
glycol is as follows:
apparatus
Gas chromatograph with hydrogen flame ionization detector (Varian
Aerograph 600 D or equivalent). The following conditions shall be
employed with the Varian Aerograph 600 D gas chromatograph:
Column temperature: 165 [deg]C.
Inlet temperature: 260 [deg]C.
Carrier gas (nitrogen) flow rate: 70 milliliters per minute.
Hydrogen and air flow to burner: Optimize to give maximum
sensitivity.
Sample size: 2 microliters.
Elution time: Ethylene glycol: 2.0 minutes. Diethylene glycol: 6.5
minutes.
Recorder: -0.5 to +1.05 millivolt, full span, 1 second full response
time.
Syringe: 10-microliter (Hamilton 710 N or equivalent).
Chromatograph column: 5 feet x \1/8\ inch. I.D. stainless steel tube
packed with sorbitol (Mathieson-Coleman-Bell 2768 Sorbitol
[[Page 84]]
SX850, or equivalent) 12 percent in H2O by weight on 60-80
mesh nonacid washed diatomaceous earth (Chromosorb W. Johns-Manville, or
equivalent).
reagents and materials
Carrier gas, nitrogen: Commercial grade in cylinder equipped with
reducing regulator to provide 50 p.s.i.g. to the gas chromatograph.
Ethylene glycol: Commercial grade. Purify if necessary, by
distillation.
Diethylene glycol: Commercial grade. Purify, if necessary, by
distillation.
Glycol standards: Prepare chromatographic standards by dissolving
known amounts of ethylene glycol and diethylene glycol in water.
Suitable concentrations for standardization range from 1 to 6 milligrams
of each component per milliliter (for example 10 milligrams diluted to
volume in a 10-milliliter volumetric flask is equivalent to 1 milligram
per milliliter).
standardization
Inject a 2-microliter aliquot of the glycol standard into the gas
chromatograph employing the conditions described above. Measure the net
peak heights for the ethylene glycol and for the diethylene glycol.
Record the values as follows:
A=Peak height in millimeters of the ethylene glycol peak.
B=milligrams of ethylene glycol per milliliter of standard solution.
C=Peak height in millimeters of the diethylene glycol peak.
D=Milligrams of diethylene glycol per milliliter of standard
solution.
procedure
Weigh approximately 4 grams of polyethylene glycol sample accurately
into a 10-milliliter volumetric flask. Dilute to volume with water. Mix
the solution thoroughly and inject a 2-microliter aliquot into the gas
chromatograph. Measure the heights, in millimeters, of the ethylene
glycol peak and of the diethylene glycol peak and record as E and F,
respectively.
Percent ethylene glycol=(ExB)/(Axsample weight in grams)
Percent diethylene glycol=(FxD)/(Cxsample weight in grams)
(c) Uses. It may be used, except in milk or preparations intended
for addition to milk, as follows:
(1) As a coating, binder, plasticizing agent, and/or lubricant in
tablets used for food.
(2) As an adjuvant to improve flavor and as a bodying agent in
nonnutritive sweeteners identified in Sec. 180.37 of this chapter.
(3) As an adjuvant in dispersing vitamin and/or mineral
preparations.
(4) As a coating on sodium nitrite to inhibit hygroscopic
properties.
(d) Limitations. (1) It is used in an amount not greater than that
required to produce the intended physical or technical effect.
(2) A tolerance of zero is established for residues of polyethylene
glycol in milk.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]
Additives that reference this regulation: |
