[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR180.37]

[Page 460-461]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
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 sodium 
saccharin.

    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--
federal--regulations/ibr--locations.html.
    (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

[[Page 461]]

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 
fluid ounce.
    (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 
products.
    (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 
shall bear:
    (i) The name of the additive.
    (ii) The amount of the additive, calculated as saccharin, as 
follows:
    (a) For beverages, in milligrams per fluid ounce;
    (b) For cooking or table use products, in milligrams per dispensing 
unit;
    (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]