[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 180_FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN
INTERIM BASIS PENDING ADDITIONAL STUDY--Table of Contents
Subpart B_Specific Requirements for Certain Food Additives
Sec. 180.37 Saccharin, ammonium saccharin, calcium saccharin, and
The food additives saccharin, ammonium saccharin, calcium saccharin,
and sodium saccharin may be safely used as
sweetening agents in food in accordance with the following conditions,
if the substitution for nutritive sweeteners is for a valid special
dietary purpose and is in accord with current special dietary food
regulations and policies or if the use or intended use is for an
authorized technological purpose other than calorie reduction:
(a) Saccharin is the chemical, 1,2-benzisothiazolin-3-one - 1,1 -
dioxide (C7H5NO3S). The named salts of
saccharin are produced by the additional neutralization of saccharin
with the proper base to yield the desired salt.
(b) The food additives meet the specifications of the ``Food
Chemicals Codex,'' 3d Ed. (1981), pp. 22, 62, 266-267, 297-299, which is
incorporated by reference. Copies may be obtained from the National
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may
be examined 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--
(c) Authority for such use shall expire when the Commissioner
receives the final reports on the ongoing studies in Canada and
publishes an order on the safety of saccharin and its salts based on
those reports and other available data.
(d) The additives are used or intended for use as a sweetening agent
only in special dietary foods, as follows:
(1) In beverages, fruit juice drinks, and bases or mixes when
prepared for consumption in accordance with directions, in amounts not
to exceed 12 milligrams of the additive, calculated as saccharin, per
(2) As a sugar substitute for cooking or table use, in amounts not
to exceed 20 milligrams of the additive, calculated as saccharin, for
each expressed teaspoonful of sugar sweetening equivalency.
(3) In processed foods, in amounts not to exceed 30 milligrams of
the additive, calculated as saccharin, per serving of designated size.
(e) The additives are used or intended for use only for the
following technological purposes:
(1) To reduce bulk and enhance flavors in chewable vitamin tablets,
chewable mineral tablets, or combinations thereof.
(2) To retain flavor and physical properties of chewing gum.
(3) To enhance flavor of flavor chips used in nonstandardized bakery
(f) To assure safe use of the additives, in addition to the other
information required by the Act:
(1) The label of the additive and any intermediate mixes of the
additive for manufacturing purposes shall bear:
(i) The name of the additive.
(ii) A statement of the concentration of the additive, expressed as
saccharin, in any intermediate mix.
(iii) Adequate directions for use to provide a final food product
that complies with the limitations prescribed in paragraphs (d) and (e)
of this section.
(2) The label of any finished food product containing the additive
(i) The name of the additive.
(ii) The amount of the additive, calculated as saccharin, as
(a) For beverages, in milligrams per fluid ounce;
(b) For cooking or table use products, in milligrams per dispensing
(c) For processed foods, in terms of the weight or size of a serving
which shall be that quantity of the food containing 30 milligrams or
less of the additive.
(iii) When the additive is used for calorie reduction, such other
labeling as is required by part 105 or Sec. 100.130 of this chapter.
[42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984]
Additives that reference this regulation: