[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
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.
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(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
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: