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184.1585 Papain.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1585 Papain.



[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: 21CFR184.1585]

[Page 550-551]
 
                        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.  184.1585  Papain.

    (a) Papain (CAS Reg. No. 9001-73-4) is a proteolytic enzyme derived 
from Carica papaya L. Crude latex containing the enzyme is collected 
from slashed unripe papaya. The food-grade product is obtained by 
repeated filtration of the crude latex or an aqueous solution of latex 
or by precipitation from an aqueous solution of latex. The resulting 
enzyme preparation may be used in a liquid or dry form.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), pp. 107-110, 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 currect 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 conditions of use:
    (1) The ingredient is used as an enzyme as defined in Sec.  
170.3(o)(9) of this chapter; processing aid as defined in Sec.  
170.3(o)(24) of this chapter; and

[[Page 551]]

texturizer as defined in Sec.  170.3(o)(32) 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 48806, Oct. 21, 1983]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1585


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