[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: |
