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184.1245 Beta-carotene.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1245 Beta-carotene.



[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: 21CFR184.1245]

[Page 509]
 
                        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.  184.1245  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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1245


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