[Title 21 CFR 184.1165]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)]
[Subchapter B - FOOD FOR HUMAN CONSUMPTION]
[Part 184 - DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE]
[Subpart B - Listing of Specific Substances Affirmed as GRAS]
[Sec. 184.1165 - n-Butane and iso-butane.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  3
  1996-04-01
  1996-04-01
  false
  
  184.1165
  Sec. 184.1165
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
    FOOD FOR HUMAN CONSUMPTION
    DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
    Listing of Specific Substances Affirmed as GRAS
  


Sec. 184.1165  n-Butane and iso-butane.

    (a) n-Butane and iso-butane (empirical formula C4H10, CAS 
Reg. Nos. 106-97-8 and 75-28-5, respectively) are colorless, odorless, 
flammable gases at normal temperatures and pressures. They are easily 
liquefied under pressure at room temperature and are stored and shipped 
in the liquid state. The butanes are obtained from natural gas by 
fractionation following absorption in oil, adsorption to surface-active 
agents, or refrigeration.
    (b) The Food and Drug Administration is developing food-grade 
specifications for n-butane and iso-butane in cooperation with the 
National Academy of Sciences. In the interim, the ingredients must be of 
a purity suitable for their intended use.
    (c) In accordance with Sec. 184.1(b)(1), these ingredients are used 
in food with no limitations other than current good manufacturing 
practice. The affirmation of these ingredients as generally recognized 
as safe (GRAS) as direct human food ingredients is based upon the 
following current good manufacturing practice conditions of use:
    (1) The ingredients are used as propellants, aerating agents, and 
gases as defined in Sec. 170.3(o)(25) of this chapter.
    (2) The ingredients are used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for these ingredients different from the uses 
established in this section do not exist or have been waived.

[48 FR 57270, Dec. 29, 1983]