[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: 21CFR184.1553]
[Page 548]
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. 184.1553 Peptones.
(a) Peptones are a variable mixture of polypeptides, oligopeptides,
and amino acids that are produced by partial hydrolysis of casein,
animal tissue, soy protein isolate, gelatin, defatted fatty tissue, egg
albumin, or lactalbumin (whey protein). Peptones are produced from these
proteins using proteolytic enzymes that either are considered to be
generally recognized as safe (GRAS) or are regulated as food additives.
Peptones are also produced by denaturing any of the proteins listed in
this paragraph with safe and suitable acids or heat.
(b) FDA is developing food-grade specifications for peptones in
cooperation with the National Academy of Sciences. In the interim, these
ingredients must be of a purity suitable for their intended use.
(c) In accordance with Sec. 184.1(b)(1), these ingredients are used
in food with no limitation other than current good manufacturing
practice. The affirmation of these ingredients as GRAS as direct human
food ingredients is based upon the following current good manufacturing
practice conditions of use:
(1) These ingredients are used as nutrient supplements as defined in
Sec. 170.3(o)(20) of this chapter; as processing aids as defined in
Sec. 170.3(o)(24) of this chapter; and as surface-active agents as
defined in Sec. 170.3(o)(29) of this chapter.
(2) These 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.
[49 FR 25430, June 21, 1984, as amended at 50 FR 49536, Dec. 3, 1985]
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