[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1024]

[Page 467]
 
                        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. 184.1024  Bromelain.

    (a) Bromelain (CAS Reg. No. 9001-00-7) is an enzyme preparation 
derived from the pineapples Ananas comosus and A. bracteatus L. It is a 
white to light tan amorphous powder. Its characterizing enzyme activity 
is that of a peptide hydrolase (EC 3.4.22.32).
    (b) The ingredient meets the general requirements and additional 
requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. 
(1981), p. 110, which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National 
Academy Press, 2101 Constitution Ave. NW., Washington, DC, or may be 
examined at the Office of Premarket Approval (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC, and the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as GRAS as a direct food ingredient 
is based upon the following current good manufacturing practice 
conditions of use:
    (1) The ingredient is used as an enzyme as defined in 
Sec. 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.

[60 FR 32910, June 26, 1995]