[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS
SAFE--Table of Contents
Subpart B_Listing of Specific Substances Affirmed as GRAS
Sec. 184.1984 Zein.
(a) Zein (CAS Reg. No. 9010-66-6) is one of the components of corn
gluten. It is produced commercially by extraction from corn gluten with
alkaline aqueous isopropyl alcohol containing sodium hydroxide. The
extract is then cooled, which causes the zein to precipitate.
(b) FDA is developing food-grade specifications for zein in
cooperation with the National Academy of Sciences. In the interim, the
igredient 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 surface-finishing agent as defined
in Sec. 170.3(o)(30) 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 8999, Mar. 6, 1985]
Additives that reference this regulation:
Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1984
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