[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1063]

[Page 477-478]
 
                        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. 184.1063  Enzyme-modified lecithin.

    (a) Enzyme-modified lecithin is prepared by treating lecithin with 
either

[[Page 478]]

phospholipase A2 (EC 3.1.1.4) or pancreatin.
    (b) The ingredient meets the specifications in paragraphs (b)(1) 
through (b)(8) of this section. Unless otherwise noted, compliance with 
the specifications listed below is determined according to the methods 
set forth for lecithin in the Food Chemicals Codex, 4th ed. (1996), pp. 
220-221, 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 Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (1) Acetone-insoluble matter (phosphatides), not less than 50.0 
percent.
    (2) Acid value, not more than 40.
    (3) Lead, not more than 1.0 part per million, as determined by 
atomic absorption spectroscopy.
    (4) Heavy metals (as Pb), not more than 20 parts per million.
    (5) Hexane-insoluble matter, not more than 0.3 percent.
    (6) Peroxide value, not more than 20.
    (7) Water, not more than 4.0 percent.
    (8) Lysolecithin, 50 to 80 mole percent of total phosphatides as 
determined by ``Determination of Lysolecithin Content of Enzyme-Modified 
Lecithin: Method I,'' dated 1985, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available 
from the Division of Petition Control, Center for Food Safety and 
Applied Nutrition (HFS-215), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 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 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 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 emulsifier as defined in Sec. 
170.3(o)(8) of this chapter.
    (2) The ingredient is used at levels not to exceed current good 
manufacturing practice.

[61 FR 45889, Aug. 30, 1996]