Sec. 172.133 Dimethyl dicarbonate.
Dimethyl dicarbonate (CAS Reg. No. 4525-33-1) may be safely used in
food in accordance with the following prescribed conditions:
(a) The additive meets the following specifications:
(1) The additive has a purity of not less than 99.8 percent as
determined by the following titration method:
Principles of method
Dimethyl dicarbonate (DMDC) is mixed with excess diisobutylamine
with which it reacts quantitatively. The excess amine is backtitrated
with acid.
Method deleted
(2) The additive contains not more than 2,000 ppm (0.2 percent)
dimethyl carbonate as determined by a method entitled ``Gas
Chromatography Method for Dimethyl Carbonate Impurity in Dimethyl
Dicarbonate,'' whichis incorporated by reference in accordance with 5
U.S.C. 552(a). Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-200), 200 C Street SW., Washington, DC 20204, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408.
(b) The additive is used or intended for use as follows:
(1) Inhibitor of yeast in wine, dealcoholized wine, and low alcohol
wine, under normal circumstances of bottling where the viable yeast
count has been reduced to 500 per milliliter or less by current good
manufacturing practices such as flash pasteurization or filtration. The
additive may be added to wine, dealcoholized wine, or low alcohol wine in an amount not to exceed 200 parts per million (ppm).
(2) Inhibitor of yeast in ready-to-drink teas, under normal
circumstances of bottling or canning where the viable yeast count has
been reduced to 500 per milliliter or less by current good manufacturing
practices such as heat treatment, sterile filtration, or both. The
additive may be added to teas in an amount not to exceed 250 ppm.
(3) Inhibitor of yeast in carbonated or noncarbonated, nonjuice-
containing (less than or equal to 1 percent juice), flavored or
unflavored beverages containing added electrolytes (5-20
milliequivalents (meq)/liter sodium ion (Na+) and 3-7 meq/liter
potassium ion (K+)). The additive may be added to the beverage in an
amount not to exceed 250 ppm.
(4) Inhibitor of yeast in carbonated, dilute beverages containing
juice, fruit flavor, or both, with juice content not to exceed 50
percent. The additive may be added to the beverage in an amount not to
exceed 250 ppm.
(c) To ensure the safe use of the food additive, the label of the
package containing the additive shall bear, in addition to other
information required by the Federal Food, Drug, and Cosmetic Act:
(1) The name of the additive ``dimethyl dicarbonate.''
(2) Directions to provide that not more than 200 ppm of dimethyl
dicarbonate will be added to the wine, dealcoholized wine, or low
alcohol wine and not more than 250 ppm of dimethyl dicarbonate will be
added to the ready-to-drink tea or to the beverages described in parts
(b)(3) and (b)(4) of this section.
[53 FR 41329, Oct. 21, 1988, as amended at 58 FR 6091, Jan. 26, 1993; 59
FR 5319, Feb. 4, 1994; 61 FR 14245, Apr. 1, 1996; 61 FR 26788, May 29,
1996]