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184.1930 Vitamin A.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1930 Vitamin A.



[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: 21CFR184.1930]

[Page 575]
 
                        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.  184.1930  Vitamin A.

    (a)(1) Vitamin A (retinol; CAS Reg. No. 68-26-8) is the alcohol 
9,13-dimethyl-7-(1,1,5-trimethyl-6-cyclohexen-5-yl)-7,9,11,13-
nonatetraen-15-ol. It may be nearly odorless or have a mild fishy odor. 
Vitamin A is extracted from fish liver oils or produced by total 
synthesis from [beta]-ionone and a propargyl halide.
    (2) Vitamin A acetate (retinyl acetate; CAS Reg. No. 127-47-9) is 
the acetate ester of retinol. It is prepared by esterifying retinol with 
acetic acid.
    (3) Vitamin A palmitate (retinyl palmitate; CAS Reg. No. 79-81-2) is 
the palmitate ester of retinol. It is prepared by esterifying retinol 
with palmitic acid.
    (b) The ingredient meets the specifications for vitamin A in the 
Food Chemicals Codex, 3d Ed. (1981), p. 342, which is incorporated by 
reference. Copies are available from the National Academy Press, 2101 
Constitution Ave. NW., Washington, 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 in food as a nutrient supplement as 
defined in Sec.  170.3(o)(20) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice. Vitamin A may be used in infant formula in 
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic 
Act (the act) or with regulations promulgated under section 412(a)(2) of 
the Act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 51610, Nov. 10, 1983]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1930


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