[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: 21CFR184.1890]
[Page 572]
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. 184.1890 [b.alpha]-Tocopherols.
(a) The [alpha]-tocopherols that are the subject of this GRAS
affirmation regulation are limited to the following:
(1) d-[alpha]-Tocopherol (CAS Reg. No. 59-02-9) is the chemical
[2R,4'R,8prime;R]-2,5,7,8-tetramethyl-2-(4',8',12'-trimethyl-tridecyl)-
6-chromanol. It occurs commercially as a concentrate and is a red,
nearly odorless, viscous oil. It is obtained by vacuum steam
distillation of edible vegetable oil products.
(2) dl-[alpha]-Tocopherol (CAS Reg. No. 10191-41-0) is a mixture of
stereoisomers of 2,5,7,8-tetramethyl-2-(4',8',12'-trimethyl-tridecyl)-6-
chromanol. It is chemically synthesized by condensing racemic isophytol
with trimethyl hydroquinone. It is a pale yellow viscous oil at room
temperature.
(b) The ingredients meet the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 330-331, which is incorporated by reference.
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(c) In accordance with Sec. 184.1(b)(3), the affirmation of the
ingredients as generally recognized as safe is limited to the following
conditions of use while the agency concludes the general evaluation of
all food uses of tocopherols:
(1) The ingredients are used as inhibitors of nitrosamine formation.
(2) The ingredients are used in pump-cured bacon at levels not to
exceed current good manufacturing practice.
[49 FR 13348, Apr. 4, 1984]
Additives that reference this regulation: |