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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Aug 30, 2024.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 3]
[CITE: 21CFR184.1848]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 184 -- DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

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) The ingredient must be of a purity suitable for its intended use.

(c) In accordance with § 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 § 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, as amended at 73 FR 8608, Feb. 14, 2008]

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