This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated April 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR168]
[Page 542]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 168--SWEETENERS AND TABLE SIRUPS--Table of Contents
Subpart A [Reserved]
Subpart B--Requirements for Specific Standardized Sweeteners and Table
Sirups
Sec.
168.110 Dextrose anhydrous.
168.111 Dextrose monohydrate.
168.120 Glucose sirup.
168.121 Dried glucose sirup.
168.122 Lactose.
168.130 Cane sirup.
168.140 Maple sirup.
168.160 Sorghum sirup.
168.180 Table sirup.
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
Source: 42 FR 14479, Mar. 15, 1977, unless otherwise noted.
Subpart A [Reserved]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR168.110]
[Page 542]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 168--SWEETENERS AND TABLE SIRUPS--Table of Contents
Subpart B--Requirements for Specific Standardized Sweeteners and Table
Sirups
Sec. 168.110 Dextrose anhydrous.
(a) Dextrose anhydrous is purified and crystallized D-glucose
without water of crystallization and conforms to the specifications of
Sec. 168.111, except that the total solids content is not less than 98.0
percent m/m.
(b) The name of the food is "Dextrose anhydrous" or "Anhydrous
dextrose" or alternatively, "------ sugar anhydrous" or "Anhydrous
sugar", with the blank to be filled with the name of the food source,
for example, "Corn sugar anhydrous".
[42 FR 14479, Mar. 15, 1977, as amended at 58 FR 2886, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR168.111]
[Page 542]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 168--SWEETENERS AND TABLE SIRUPS--Table of Contents
Subpart B--Requirements for Specific Standardized Sweeteners and Table
Sirups
Sec. 168.111 Dextrose monohydrate.
(a) Dextrose monohydrate is purified and crystallized D-glucose
containing one molecule of water of crystallization with each molecule
of D-glucose.
(b) The food shall meet the following specifications:
(1) The total solids content is not less than 90.0 percent mass/mass
(m/m), and the reducing sugar content (dextrose equivalent), expressed
as D-glucose, is not less than 99.5 percent m/m calculated on a dry
basis.
(2) The sulfated ash content is not more than 0.25 percent m/m
(calculated on a dry basis), and the sulfur dioxide content is not more
than 20 mg/kg.
(c) The name of the food is "Dextrose monohydrate" or "Dextrose"
or alternatively, "------ sugar monohydrate" or "------ sugar", with
the blank to be filled with the name of the food source, for example,
"Corn sugar monohydrate" or "Corn sugar".
(d) For purposes of this section, the methods of analysis to be used
to determine if the food meets the specifications of paragraph (b) (1)
and (2) of this section are the following sections in "Official Methods
of Analysis of the Association of Official Analytical Chemists," 13th
Ed. (1980), which is incorporated by reference. Copies may be obtained
from the Association of Official Analytical Chemists International, 481
North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be
examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC.
(1) Total solids content, 31.005.
(2) Reducing sugar content, section 31.220(a).
(3) Sulfated ash content, section 31.216.
(4) Sulfur dioxide content, sections 20.106-20.111.
[42 FR 14479, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19, 1982;
49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 58 FR 2886, Jan.
6, 1993; 63 FR 14035, Mar. 24, 1998]
[[Page 543]]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR168.120]
[Page 543]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 168--SWEETENERS AND TABLE SIRUPS--Table of Contents
Subpart B--Requirements for Specific Standardized Sweeteners and Table
Sirups
Sec. 168.120 Glucose sirup.
(a) Glucose sirup is the purified, concentrated, aqueous solution of
nutritive saccharides obtained from edible starch.
(b) The food shall meet the following specifications:
(1) The total solids content is not less than 70.0 percent mass/mass
(m/m), and the reducing sugar content (dextrose equivalent), expressed
as D-glucose, is not less than 20.0 percent m/m calculated on a dry
basis.
(2) The sulfated ash content is not more than 1.0 percent m/m
(calculated on a dry basis), and the sulfur dioxide content is not more
than 40 mg/kg.
(c) The name of the food is "Glucose sirup". When the food is
derived from a specific type of starch, the name may alternatively be
"------ sirup", the blank to be filled in with the name of the starch.
For example, "Corn sirup", "Wheat sirup", "Tapioca sirup". When
the starch is derived from sorghum grain, the alternative name of the
food is "Sorghum grain sirup". The word "sirup" may also be spelled
"syrup".
(d) For purposes of this section, the methods of analysis to be used
to determine if the food meets the specifications of paragraph (b)(1)
and (2) of this section are the following sections in "Official Methods
of Analysis of the Association of Official Analytical Chemists," 13th
Ed. (1980), which is incorporated by reference. Copies may be obtained
from the Association of Official Analytical Chemists International, 481
North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be
examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC.
(1) Total solids content, sections 31.208-31.209.
(2) Reducing sugar content, section 31.220(a).
(3) Sulfated ash content, section 31.216.
(4) Sulfur dioxide content, sections 20.106-20.111.
[42 FR 14479, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19, 1982;
49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 63 FR 14035,
Mar. 24, 1998]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR168.121]
[Page 543]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 168--SWEETENERS AND TABLE SIRUPS--Table of Contents
Subpart B--Requirements for Specific Standardized Sweeteners and Table
Sirups
Sec. 168.121 Dried glucose sirup.
(a) Dried glucose sirup is glucose sirup from which the water has
been partially removed and conforms to the specifications of
Sec. 168.120, except that:
(1) The total solids content is not less than 90.0 percent m/m when
the reducing sugar content (dextrose equivalent), expressed as D-
glucose, is not less than 88.0 percent m/m, calculated on a dry basis;
or
(2) The total solids content is not less than 93.0 percent m/m when
the reducing sugar content, (dextrose equivalent) expressed as D-
glucose, is less than 88.0 percent m/m, calculated on a dry basis.
(b) The name of the food is "Dried glucose sirup" or "Glucose
sirup solids". When the food is derived from a specific type of starch,
the name may alternatively be "Dried ------ sirup" or "------ sirup
solids", the blank to be filled in with the name of the starch; for
example, "Dried corn sirup", "Corn sirup solids", "Dried wheat
sirup", "Wheat sirup solids", "Dried tapioca sirup", "Tapioca
sirup solids". When the starch is derived from sorghum grain, the
alternative name of the food is "Dried sorghum grain sirup" or
"Sorghum grain sirup solids". The word "sirup" may also be spelled
"syrup".
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR168.122]
[Page 543-544]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 168--SWEETENERS AND TABLE SIRUPS--Table of Contents
Subpart B--Requirements for Specific Standardized Sweeteners and Table
Sirups
Sec. 168.122 Lactose.
(a) Lactose is the carbohydrate normally obtained from whey. It may
be anhydrous or contain one molecule of water of crystallization or be a
mixture of both forms.
(b) The food shall meet the following specifications:
(1) The lactose content is not less than 98.0 percent, mass over
mass (m/m), calculated on a dry basis.
(2) The sulfated ash content is not more than 0.3 percent, m/m,
calculated on a dry basis.
(3) The pH of a 10.0-percent m/m solution is not less than 4.5 nor
more than 7.5.
(4) The loss on drying for 16 hours at 120 deg.C is not more than
6.0 percent, m/m.
(c) The name of the food is "Lactose" or, alternatively, "Milk
sugar".
(d) The methods of analysis in paragraphs (d)(1), (d)(2), (d)(3),
(d)(4), and
[[Page 544]]
(d)(5) of this section are to be used to determine whether the food
meets the requirements of paragraphs (b)(1), (b)(2), (b)(3), and (b)(4)
of this section. The methods are contained in "Official Methods of
Analysis of the Association of Official Analytical Chemists", 14th Ed.
(1984), including the 4th Supp. (1988), which is incorporated by
reference in accordance with 5 U.S.C. 552(a). Copies of the material
incorporated by reference may be obtained from the Association of
Official Analytical Chemists International, 481 North Frederick Ave.,
suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC.
(1) Lactose content, sections 31.064 to 31.071, "Purity of Lactose,
Liquid Chromatographic Method," First Action, 14th Ed. (1984), pp. 583
and 584.
(2) Lactose content, sections 31.064 to 31.071, "Purity of Lactose,
Liquid Chromatographic Method," "Changes in Official Methods of
Analysis," 14th Ed., 4th Supp. (1988), p. 212. This reference
recognizes the change in status of the method from first action to final
action.
(3) Sulfated ash content, section 31.014, "Ash of Sugars and
Sirups," Final Action, Sulfated Ash, 14th Ed. (1984), p. 575.
(4) pH, section 14.022, "pH of Flour, Potentiometric Method,"
Final Action, except that a 10-percent m/m solution of lactose in water
is used for the determination, 14th Ed. (1984), p. 252.
(5) Loss on drying at 120 deg.C, section 31.070, 14th Ed. (1984),
p. 584.
[42 FR 14479, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19, 1982;
49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 55 FR 8459, Mar.
8, 1990; 63 FR 14035, Mar. 24, 1998]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR168.130]
[Page 544]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 168--SWEETENERS AND TABLE SIRUPS--Table of Contents
Subpart B--Requirements for Specific Standardized Sweeteners and Table
Sirups
Sec. 168.130 Cane sirup.
(a) Cane sirup is the liquid food derived by concentration and heat
treatment of the juice of sugarcane (Saccharum officinarum L.) or by
solution in water of sugarcane concrete made from such juice. It
contains not less than 74 percent by weight of soluble solids derived
solely from such juice. The concentration may be adjusted with or
without added water. It may contain one or more of the optional
ingredients provided for in paragraph (b) of this section. All
ingredients from which the food is fabricated shall be safe and
suitable.
(b) The optional ingredients that may be used in cane sirup are:
(1) Salt.
(2) Preservatives.
(3) Defoaming agents.
(c) The name of the food is "Cane sirup" or "Sugar cane sirup".
Alternatively, the word "sirup" may be spelled "syrup".
(d) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
[42 FR 14479, Mar. 15, 1977, as amended at 58 FR 2886, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR168.140]
[Page 544]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 168--SWEETENERS AND TABLE SIRUPS--Table of Contents
Subpart B--Requirements for Specific Standardized Sweeteners and Table
Sirups
Sec. 168.140 Maple sirup.
(a) Maple sirup is the liquid food derived by concentration and heat
treatment of the sap of the maple tree (Acer) or by solution in water of
maple sugar (mapel concrete) made from such sap. It contains not less
than 66 percent by weight of soluble solids derived solely from such
sap. The concentration may be adjusted with or without added water. It
may contain one or more of the optional ingredients provided for in
paragraph (b) of this section. All ingredients from which the food is
fabricated shall be safe and suitable.
(b) The optional ingredients that may be used in maple sirup are:
(1) Salt.
(2) Chemical preservatives.
(3) Defoaming agents.
(c) The name of the food is "Maple sirup". Alternatively, the word
"sirup" may be spelled "syrup".
(d) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
[42 FR 14479, Mar. 15, 1977, as amended at 58 FR 2896, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR168.160]
[Page 544-545]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 168--SWEETENERS AND TABLE SIRUPS--Table of Contents
Subpart B--Requirements for Specific Standardized Sweeteners and Table
Sirups
Sec. 168.160 Sorghum sirup.
(a) Sorghum sirup is the liquid food derived by concentration and
heat treatment of the juice of sorghum cane (sorgos) (Sorghum vulgare).
It contains not less than 74 percent by weight of
[[Page 545]]
soluble solids derived solely from such juice. The concentration may be
adjusted with or without added water. It may contain one or more of the
optional ingredients provided for in paragraph (b) of this section. All
ingredients from which the food is fabricated shall be safe and
suitable.
(b) The optional ingredients that may be used in sorghum sirup are:
(1) Salt.
(2) Chemical preservatives.
(3) Defoaming agents.
(4) Enzymes.
(5) Anticrystallizing agents.
(6) Antisolidifying agents.
(c) The name of the food is "Sorghum sirup" or "Sorghum".
Alternatively, the word "sirup" may be spelled "syrup".
(d) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
[42 FR 14479, Mar. 15, 1977, as amended at 58 FR 2886, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR168.180]
[Page 545-546]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 168--SWEETENERS AND TABLE SIRUPS--Table of Contents
Subpart B--Requirements for Specific Standardized Sweeteners and Table
Sirups
Sec. 168.180 Table sirup.
(a) Table sirup is the liquid food consisting of one or more of the
optional sweetening ingredients provided for in paragraph (b)(1) of this
section. The food contains not less than 65 percent soluble sweetener
solids by weight and is prepared with or without added water. It may
contain one or more of the optional ingredients prescribed in paragraphs
(b)(2) through (12) of this section. All ingredients from which the food
is fabricated shall be safe and suitable. (Vitamins, minerals, and
protein added for nutritional purposes and artificial sweeteners are not
considered to be suitable ingredients for this food.)
(b) The optional ingredients that may be used in table sirup are:
(1) One or more of the nutritive carbohydrate sweeteners provided
for in this paragraph (b)(1). When a sweetener provided for in paragraph
(b)(1)(i) or (ii) of this section is used it shall constitute not less
than 2 percent by weight of the finished food.
(i) The sirups identified by Secs. 168.130, 168.140, and 168.160,
except that the use of any such ingredient is so limited that the
finished food does not meet the requirement prescribed for any sirup by
Secs. 168.130, 168.140, or 168.160.
(ii) Honey.
(iii) Other nutritive carbohydrate sweeteners.
(2) Butter, in a quantity not less than 2 percent by weight of the
finished food.
(3) Edible fats and oils, except that, in products designated as
"buttered sirups", butter as provided for in paragraph (b)(2) of this
section is the only fat that may be used.
(4) Emulsifiers or stabilizers or both.
(5) Natural and artificial flavorings, either fruit or nonfruit,
alone or in carriers.
(6) Color additives.
(7) Salt.
(8) Chemical preservatives.
(9) Viscosity adjusting agents.
(10) Acidifying, alkalizing, or buffering agents.
(11) Defoaming agents.
(12) Any other ingredient (e.g., shredded coconut, ground orange
peel) that is not incompatible with other ingredients in the food.
(c) Except as provided for in this paragraph and in paragraphs (d)
(2) and (3) of this section, the name of the food is "Table sirup",
"Sirup", "Pancake sirup", "Waffle sirup", "Pancake and waffle
sirup", or "------ sirup", the blank being filled in with the word or
words that designate the sweetening ingredient that characterizes the
food, except "maple", "cane", or "sorghum" alone, such sirups
being required to comply in all respects with Secs. 168.130, 168.140,
and 168.160, respectively, and in the case of more than one sweetening
ingredient, in descending order of predominance by weight in the food.
The type shall be of uniform style and size.
(1) When one of the sweeteners constitutes at least 80 percent of
the total sweetener solids, the name of the food may be designated as
the corresponding sirup, for example, "Corn sirup", provided that the
name is immediately and conspicuously followed, without intervening
written, printed, or graphic matter, by the statement "with ------" as
part of the name, the blank being filled in with the name or names of
each additional sweetening ingredient present, stated in a clear legible
manner in letters of uniform
[[Page 546]]
style and size not less than one-half the height of, nor larger than,
the letters used in the name of the principal sweetener.
(2) When butter is used, as provided for in paragraph (b)(2) of this
section, the name of the food may be "Buttered ------", the blank
being filled in with the name otherwise prescribed in this paragraph.
The percentage by weight of butter present shall be declared as part of
the name of the food as prescribed by part 102 of this chapter.
(3) Alternatively, the word "sirup" may be spelled "syrup".
(d)(1) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
(2) A statement (other than in the ingredient listing) or a vignette
identifying a flavor may be included on the label only if such flavor
contributes the primary recognizable flavor that characterizes the
sirup. When maple, honey, or both maple and honey are represented as the
characterizing flavors, the total quantity of maple sirup or honey,
singly, or of maple sirup and honey in combination, shall be not less
than 10 percent by weight of the finished food. The presence of any
natural or artificial flavor in the food shall be declared on the label
as prescribed by the applicable sections of part 101 of this chapter.
(3) The percentage of any optional ingredient used shall be declared
as part of the name of the food as prescribed by part 102 of this
chapter when all of the following conditions apply to the use of the
ingredient:
(i) It is one of the characterizing ingredients permitted by
paragraphs (b)(1) (i) and (ii) of this section.
(ii) The ingredient is either named on the label other than in the
list of ingredients or is suggested by vignette or other labeling.
[42 FR 14479, Mar. 15, 1977, as amended at 58 FR 2886, Jan. 6, 1993]