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184.1415 Animal lipase.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1415 Animal lipase.



[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: 21CFR184.1415]

[Page 534]
 
                        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.  184.1415  Animal lipase.

    (a) Animal lipase (CAS Reg. No. 9001-62-1) is an enzyme preparation 
obtained from edible forestomach tissue of calves, kids, or lambs, or 
from animal pancreatic tissue. The enzyme preparation may be produced as 
a tissue preparation or as an aqueous extract. Its characterizing enzyme 
activity is that of a triacylglycerol hydrolase (EC 3.1.1.3).
    (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 20418, or may 
be examined at the Office of Premarket Approval (HFS-200), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and 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 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 fatty acid glycerides.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.

[60 FR 32911, June 26, 1995]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1415


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