[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1287]
[Page 516]
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
Subpart B Listing of Specific Substances Affirmed as GRAS
Sec. 184.1287 Enzyme-modified fats.
(a) Enzyme-modified refined beef fat, enzyme-modified butterfat, and
enzyme-modified steam-rendered chicken fat are prepared from refined
beef fat; butterfat or milkfat; and steam-rendered chicken fat,
respectively, with enzymes that are generally recognized as safe (GRAS).
Enzyme-modified milk powder may be prepared with GRAS enzymes from
reconstituted milk powder, whole milk, condensed or concentrated whole
milk, evaporated milk, or milk powder. The lipolysis is maintained at a
temperature that is optimal for the action of the enzyme until
appropriate acid development is attained. The enzymes are then
inactivated. The resulting product is concentrated or dried.
(b) FDA is developing food-grade specifications for these enzyme-
modified ingredients in cooperation with the National Academy of
Sciences. In the interim, the ingredients must be of purity suitable for
their intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredients are used
in food with no limitation other than current good manufacturing
practice. The affirmation of these ingredients as generally recognized
as safe (GRAS) as direct human food ingredients is based upon the
following current good manufacturing practice conditions of use:
(1) The ingredients are used as flavoring agents and adjuvants as
defined in Sec. 170.3(o)(12) of this chapter.
(2) The ingredients are used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
[52 FR 25976, July 10, 1987]
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