[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: 21CFR184.1355]
[Page 528]
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. 184.1355 Helium.
(a) Helium (empirical formula He, CAS Reg. No. 7440-59-7) is a
colorless, odorless, flavorless, nonflammable, inert gas. It is lighter
than air and is produced by the liquefaction and purification of natural
gas.
(b) The Food and Drug Administration is developing food-grade
specifications for helium in cooperation with the National Academy of
Sciences. In the interim, the ingredient must be of a purity suitable
for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitations 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 processing aid as defined in Sec.
170.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 57270, Dec. 29, 1983]
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