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184.1388 Lactase enzyme preparation from Kluyveromyces lactis.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1388 Lactase enzyme preparation from Kluyveromyces lactis.



[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: 21CFR184.1388]

[Page 531-532]
 
                        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.  184.1388  Lactase enzyme preparation from Kluyveromyces lactis.

    (a) This enzyme preparation is derived from the nonpathogenic, 
nontoxicogenic yeast Kluyveromyces lactis (previously named 
Saccharomyces lactis). It contains the enzyme [Beta]-galactoside 
galactohydrase (CAS Reg.

[[Page 532]]

No. CBS 683), which converts lactose to glucose and galactose. It is 
prepared from yeast that has been grown in a pure culture fermentation 
and by using materials that are generally recognized as safe or are food 
additives that have been approved for this use by the Food and Drug 
Administration.
    (b) The ingredient meets the general and additional requirements for 
enzyme preparations in the Food Chemicals Codex, 3d Ed. (1981), p. 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 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 to 
use this ingredient in milk to produce lactase-treated milk, which 
contains less lactose than regular milk, or lactose-reduced milk, which 
contains at least 70 percent less lactose than regular milk.

[49 FR 47387, Dec. 4, 1984]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1388


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