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184.1212 Calcium pantothenate.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1212 Calcium pantothenate.



[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: 21CFR184.1212]

[Page 506-507]
 
                        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.  184.1212  Calcium pantothenate.

    (a) Calcium pantothenate 
((C9H16NO5)2Ca, CAS Reg. No. 
of the D-isomer, 137-08-6) is a salt of pantothenic acid, one of the 
vitamins of the B complex. Only the D-isomer of pantothenic acid has 
vitamin activity, although both the D-isomer and the DL-racemic mixture 
of calcium pantothenate are used in food. Commercial calcium 
pantothenate is prepared synthetically from isobutyraldehyde and 
formaldehyde via 1,1-dimethyl-2-hydroxy-propionaldehyde and 
pantolactone.
    (b) Calcium pantothenate meets the specifications of the Food 
Chemicals Codex, 3d Ed. (1981), p. 56, 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 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. Calcium pantothenate may be used in infant 
formula in accordance with section 412(g) of the Federal Food, Drug, and 
Cosmetic Act

[[Page 507]]

(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 51908, Nov. 15, 1983]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1212


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