[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS
SAFE--Table of Contents
Subpart B_Listing of Specific Substances Affirmed as GRAS
Sec. 184.1848 Starter distillate.
(a) Starter distillate (butter starter distillate) is a steam
distillate of the culture of any or all of the following species of
bacteria grown on a medium consisting of skim milk usually fortified
with about 0.1 percent citric acid: Streptococcus lactis, S. cremoris,
S. lactis subsp. diacetylactis, Leuconostoc citrovorum, and L.
dextranicum. The ingredient contains more than 98 percent water, and the
remainder is a mixture of butterlike flavor compounds. Diacetyl is the
major flavor component, constituting as much as 80 to 90 percent of the
mixture of organic flavor compounds. Besides diacetyl, starter
distillate contains minor amounts of acetaldehyde, ethyl formate, ethyl
acetate, acetone, ethyl alcohol, 2-butanone, acetic acid, and acetoin.
(b) FDA is developing food-grade specifications for starter
distillate in cooperation with the National Academy of Sciences. In the
interim, this ingredient must be of a purity suitable for its intended
(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
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 51907, Nov. 15, 1983]
Additives that reference this regulation: