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184.1387 Lactase enzyme preparation from Candida pseudotropicalis.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1387 Lactase enzyme preparation from Candida pseudotropicalis.



[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: 21CFR184.1387]

[Page 531]
 
                        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.  184.1387  Lactase enzyme preparation from Candida pseudotropicalis.

    (a) This enzyme preparation is derived from the nonpathogenic, 
nontoxicogenic yeast C. pseudotropicalis. It contains the enzyme lactase 
([beta]-D-galactoside galactohydrolase, EC 3.2.1.23), which converts 
lactose to glucose and galactose. It is prepared from yeast that has 
been grown by a pure culture fermentation process.
    (b) The ingredient meets the general requirements and additional 
requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. 
(1981), pp. 107-110, which are 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 Center for Food Safety and Applied 
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
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 limitations other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe as a 
direct human 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 convert lactose to glucose and 
galactose.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice. Current good manufacturing practice is 
limited to use of this ingredient to reduce the lactose content in milk 
and milk-derived food products where food standards do not preclude such 
use.

[61 FR 7704, Feb. 29, 1996]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1387


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