[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: 21CFR184.1101]
[Page 493-494]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS
SAFE--Table of Contents
Subpart B_Listing of Specific Substances Affirmed as GRAS
Sec. 184.1101 Diacetyl tartaric acid esters of mono- and diglycerides.
(a) Diacetyl tartaric acid esters of mono- and diglycerides, also
know as DATEM, are composed of mixed esters of glycerin in which one or
more of the hydroxyl groups of glycerin has been esterified by diacetyl
tartaric acid and by fatty acids. The ingredient is prepared by the
reaction of diacetyl tartaric anhydride with mono- and diglycerides that
are derived from edible sources.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d. Ed. (1981), pp. 98-99, which is incorporated by reference in
accordance
[[Page 494]]
with 5 U.S.C. 552(a). Copies are available from the National Academy
Press, 2101 Constitution Avenue NW., Washington, DC 20418, 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.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used in food as an emulsifier and emulsifier
salt as defined in Sec. 170.3(o)(8) of this chapter and a flavoring
agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods and baking mixes
as defined in Sec. 170.3(n)(l) of this chapter; nonalcoholic beverages
as defined in Sec. 170.3(n)(3) of this chapter; confections and
frostings as defined in Sec. 170.3(n)(9) of this chapter; dairy product
analogs as defined in Sec. 170.3(n)(10) of this chapter; and fats and
oils as defined in Sec. 170.3(n)(12) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(e) Labeling: The acronym ``DATEM'' may be used on food labeling as
the alternate common or usual name for the ingredient diacetyl tartaric
acid esters of mono- and diglycerides.
[54 FR 7403, Feb. 21, 1989, as amended at 54 FR 13168, Mar. 31, 1989; 54
FR 18382, Apr. 28, 1989; 60 FR 15872, Mar. 28, 1995]
Additives that reference this regulation: |
