[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.665]
[Page 70]
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
Subpart G Gums, Chewing Gum Bases and Related Substances
Sec. 172.665 Gellan gum.
The food additive gellan gum may be safely used in food in
accordance with the following prescribed conditions:
(a) The additive is a high molecular weight polysaccharide gum
produced from Pseudomonas elodea by a pure culture fermentation process
and purified by recovery with isopropyl alcohol. It is composed of
tetrasaccharide repeat units, each containing one molecule of rhamnose
and glucuronic acid, and two molecules of glucose. The glucuronic acid
is neutralized to a mixed potassium, sodium, calcium, and magnesium
salt. The polysaccharide may contain acyl (glyceryl and acetyl) groups
as the O-glycosidically linked esters.
(b) The strain of P. elodea is nonpathogenic and nontoxic in man and
animals.
(c) The additive is produced by a process that renders it free of
viable cells of P. elodea.
(d) The additive meets the following specifications:
(1) Positive for gellan gum when subjected to the following
identification tests:
(i) A 1-percent solution is made by hydrating 1 gram of gellan gum
in 99 milliliters of distilled water. The mixture is stirred for about 2
hours, using a motorized stirrer and a propeller-type stirring blade. A
small amount of the above solution is drawn into a wide bore pipet and
transferred into a solution of 10-percent calcium chloride. A tough
worm-like gel will form instantly.
(ii) To the 1-percent distilled water solution prepared for
identification test (i), 0.50 gram of sodium chloride is added. The
solution is heated to 80 [deg]C with stirring, held at 80 [deg]C for 1
minute, and allowed to cool to room temperature without stirring. A firm
gel will form.
(2) Residual isopropyl alcohol (IPA) not to exceed 0.075 percent as
determined by the procedure described in the Xanthan Gum monograph, the
``Food Chemicals Codex,'' 4th ed. (1996), pp. 437-438, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the National Academy Press, Box 285,
2101 Constitution Ave. NW., Washington, DC 20055 (Internet address
http://www.nap.edu), or may be examined at the Center for Food Safety
and Applied Nutrition's Library, Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, or 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.
(e) The additive is used or intended for use in accordance with
current good manufacturing practice as a stabilizer and thickener as
defined in Sec. 170.3(o)(28) of this chapter. The additive may be used
in foods where standards of identity established under section 401 of
the Federal Food, Drug, and Cosmetic Act do not preclude such use.
(f) To assure safe use of the additive:
(1) The label of its container shall bear, in addition to other
information required by the Federal Food, Drug, and Cosmetic Act, the
name of the additive and the designation ``food grade''.
(2) The label or labeling of the food additive container shall bear
adequate directions for use.
[55 FR 39614, Sept. 28, 1990, as amended at 57 FR 55445, Nov. 25, 1992;
64 FR 1758, Jan. 12, 1999]
[[Page 71]]
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