[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]