[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: 21CFR184.1245]
[Page 510]
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. 184.1245 Beta-carotene.
(a) Beta-carotene (CAS Reg. No. 7235-40-7) has the molecular formula
C40H56. It is synthesized by saponification of
vitamin A acetate. The resulting alcohol is either reacted to form
vitamin A Wittig reagent or oxidized to vitamin A aldehyde. Vitamin A
Wittig reagent and vitamin A aldehyde are reacted together to form beta-
carotene.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 73, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washingtion, 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 as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: dairy product analogs as
defined in Sec. 170.3(n)(10) of this chapter; fats and oils as defined
in Sec. 170.3(n)(12) of this chapter; and processed fruits and fruit
juices as defined in Sec. 170.3(n)(35) of this chapter. Beta-carotene
may be used in infant formula as a source of vitamin A in accordance
with section 412(g) of the Federal Food, Drug, and Cosmetic Act or with
regulations promulgated under section 412(g) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[52 FR 25211, July 6, 1987]
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