[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: 21CFR184.1322]
[Page 523]
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
Subpart B Listing of Specific Substances Affirmed as GRAS
Sec. 184.1322 Wheat gluten.
(a) Wheat gluten (CAS Reg. No. 8002-80-0) is the principal protein
component of wheat and consists mainly of gliadin and glutenin. Wheat
gluten is obtained by hydrating wheat flour and mechanically working the
sticky mass to separate the wheat gluten from the starch and other flour
components. Vital gluten is dried gluten that has retained its elastic
properties.
(b) FDA is developing food-grade specifications for wheat gluten in
cooperation with the National Academy of Sciences. In the interim, the
ingredient must be of a purity suitable for its intended use.
(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 as a dough strengthener as defined in
Sec. 170.3(o)(6) of this chapter; a formulation aid as defined in Sec.
170.3(o)(14) of this chapter; a nutrient supplement as defined in Sec.
170.3(o)(20) of this chapter; a processing aid as defined in Sec.
170.3(o)(24) of this chapter; a stabilizer and thickener as defined in
Sec. 170.3(o)(28) of this chapter; a surface-finishing agent as defined
in Sec. 170.3(o)(30) of this chapter; and a texturizing agent as
defined in Sec. 170.3(o)(32) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 8998, Mar. 6, 1985]
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