[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: 21CFR172.867]
[Page 105]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 172_FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN
CONSUMPTION--Table of Contents
Subpart I_Multipurpose Additives
Sec. 172.867 Olestra.
Olestra, as identified in this section, may be safely used in
accordance with the following conditions:
(a) Olestra is a mixture of octa-, hepta-, and hexa-esters of
sucrose with fatty acids derived from edible fats and oils or fatty acid
sources that are generally recognized as safe or approved for use as
food ingredients. The chain lengths of the fatty acids are no less than
12 carbon atoms.
(b) Olestra meets the specifications of the Food Chemicals Codex,
4th edition, 1st supplement (1997), pp. 33-35, which is incorporated by
reference. The Director of the Office of the Federal Register approves
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. You may obtain copies from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418 (Internet address http://
www.nap.edu). Copies may be examined at the Center for Food Safety and
Applied Nutrition's Library, Food and Drug Administration, 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) Olestra may be used in place of fats and oils in prepackaged
ready-to-eat savory (i.e., salty or piquant but not sweet) snacks and
prepackaged, unpopped popcorn kernels that are ready-to-heat. In such
foods, the additive may be used in place of fats and oils for frying or
baking, in dough conditioners, in sprays, in filling ingredients, or in
flavors.
(d) To compensate for any interference with absorption of fat
soluble vitamins, the following vitamins shall be added to foods
containing olestra: 1.9 milligrams alpha-tocopherol equivalents per gram
olestra; 51 retinol equivalents per gram olestra (as retinyl acetate or
retinyl palmitate); 12 IU vitamin D per gram olestra; and 8 [micro]g
vitamin K1 per gram olestra.
(e)(1) Vitamins A, D, E, and K present in foods as a result of the
requirement in paragraph (d) of this section shall be declared in the
listing of ingredients. Such vitamins shall not be considered in
determining nutrient content for the nutritional label or for any
nutrient claims, express or implied.
(i) An asterisk shall follow vitamins A, D, E, and K in the listing
of ingredients;
(ii) The asterisk shall appear as a superscript following each
vitamin;
(iii) Immediately following the ingredient list an asterisk and
statement, ``Dietarily insignificant'' shall appear prominently and
conspicuously as specified in Sec. 101.2(c) of this chapter;
(2) Olestra shall not be considered as a source of fat or calories
for purposes of Sec. Sec. 101.9 and 101.13 of this chapter.
[61 FR 3171, Jan. 30, 1996; 61 FR 11546, Mar. 21, 1996, as amended at 68
FR 46402, Aug. 5, 2003; 69 FR 29432, May 24, 2004]
Additives that reference this regulation: |
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