21 C.F.R. § 184.1355   Helium.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
Subpart B—Listing of Specific Substances Affirmed as GRAS

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§ 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 §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 §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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