[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: 21CFR184.1250]
[Page 510]
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. 184.1250 Cellulase enzyme preparation derived from Trichoderma
longibrachiatum.
(a) Cellulase enzyme preparation is derived from a nonpathogenic,
nontoxicogenic strain of Trichoderma longibrachiatum (formerly T.
reesei). The enzyme, cellulase, catalyzes the endohydrolysis of 1,4-
beta-glycosidic linkages in cellulose. It is obtained from the culture
filtrate resulting from a pure culture fermentation process.
(b) The ingredient meets the general and additional requirements for
enzyme preparations in the monograph specifications on enzyme
preparations in the ``Food Chemicals Codex,'' 4th ed. (1996), pp. 129 to
134, which is 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., Box 285, Washington, DC 20055
(Internet http://www.nap.edu), 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 National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call 202-741-6030, or go to: http://www.archives.gov/federal--register/
code--of--federal--regulations/ibr--locations.html.
(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 in food as an enzyme as defined in Sec.
170.3(o)(9) of this chapter for the breakdown of cellulose.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
[64 FR 28361, May 26, 1999]
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