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 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.5]
[Page 31-32]
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 A--General Provisions
Sec. 172.5 General provisions for direct food additives.
(a) Regulations prescribing conditions under which food additive
substances may be safely used predicate usage under conditions of good
manufacturing practice. For the purposes of this part, good
manufacturing practice shall be defined to include the following
restrictions.
(1) The quantity of the substance added to food does not exceed the
amount reasonably required to accomplish its intended physical,
nutritive, or other technical effect in food.
(2) Any substance intended for use in or on food is of appropriate
food grade and is prepared and handled as a food ingredient.
(b) The existence of a regulation prescribing safe conditions of use
for a food additive shall not be construed to relieve the use of the
substance from compliance with any other provision of the Act.
[[Page 32]]
(c) The existence of any regulation prescribing safe conditions of
use for a nutrient substance does not constitute a finding that the
substance is useful or required as a supplement to the diet of humans.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.105]
[Page 32]
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 B--Food Preservatives
Sec. 172.105 Anoxomer.
Anoxomer as identified in this section may be safely used in
accordance with the following conditions:
(a) Anoxomer is 1,4-benzenediol, 2-(1,1-dimethylethyl)-polymer with
diethenylbenzene, 4-(1,1-dimethyl-ethyl)phenol, 4- methoxyphenol, 4,4'-
(1-methylethylidene)bis(phenol) and 4-methylphenol (CAS Reg. No. 60837-
57-2) prepared by condensation polymerization of divinylbenzene (m- and
p-) with tert-butylhydroquinone, tert-butylphenol, hydroxyanisole, p-
cresol and 4,4'-isopropylidenediphenol.
(b) The polymeric antioxidant meets the following specifications:
(1) Polymer, not less than 98.0 percent as determined by an
ultraviolet method entitled "Ultraviolet Assay, "1982, which is
incorporated by reference. Copies are available from the Center for Food
Safety and Applied Nutrition (HFS-200), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(2) Molecular weight: Total monomers, dimers and trimers below 500
not more than 1 percent as determined by a method entitled "Low
Molecular Weight Anoxomer Analysis," 1982, which is incorporated by
reference. Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(3) Phenol content: Not less than 3.2 milliequivalent/gram and not
more than 3.8 milliequivalent/gram as determined by a method entitled
"Total Phenols," 1982, which is incorporated by reference. Copies are
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(4) Heavy metals as lead (as Pb), not more than 10 parts per
million. Arsenic (as As), not more than 3 parts per million. Mercury (as
Hg), not more than 1 part per million.
(c) Anoxomer may be safely used as an antioxidant in food at a level
of not more than 5,000 parts per million based on fat and oil content of
the food.
[48 FR 18798, Apr. 26, 1983, as amended at 54 FR 24896, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.110]
[Page 32-33]
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 B--Food Preservatives
Sec. 172.110 BHA.
The food additive BHA (butylated hydroxyanisole) alone or in
combination with other antioxidants permitted in food for human
consumption in this subpart B may be safely used in or on specified
foods, as follows:
(a) The BHA meets the following specification:
Assay (total BHA), 98.5 percent minimum. Melting point 48 deg.C
minimum.
(b) The BHA is used alone or in combination with BHT, as an
antioxidant in foods, as follows:
------------------------------------------------------------------------
Limitations
(total BHA
Food and BHT)
parts per
million
------------------------------------------------------------------------
Dehydrated potato shreds................................... 50
Active dry yeast........................................... \1\ 1,000
Beverages and desserts prepared from dry mixes............. \1\ 2
Dry breakfast cereals...................................... 50
Dry diced glazed fruit..................................... \1\ 32
Dry mixes for beverages and desserts....................... \1\ 90
Emulsion stabilizers for shortenings....................... 200
Potato flakes.............................................. 50
Potato granules............................................ 10
Sweet potato flakes........................................ 50
------------------------------------------------------------------------
\1\ BHA only.
(c) To assure safe use of the additive:
(1) The label of any market package of the additive shall bear, in
addition to the other information required by the Act, the name of the
additive.
(2) When the additive is marketed in a suitable carrier, in addition
to meeting the requirement of paragraph (c)(1) of this section, the
label shall declare
[[Page 33]]
the percentage of the additive in the mixture.
(3) The label or labeling of dry mixes for beverages and desserts
shall bear adequate directions for use to provide that beverages and
desserts prepared from the dry mixes contain no more than 2 parts per
million BHA.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.115]
[Page 33]
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 B--Food Preservatives
Sec. 172.115 BHT.
The food additive BHT (butylated hydroxytoluene), alone or in
combination with other antioxidants permitted in this subpart B may be
safely used in or on specified foods, as follows:
(a) The BHT meets the following specification: Assay (total BHT) 99
percent minimum.
(b) The BHT is used alone or in combination with BHA, as an
antioxidant in foods, as follows:
------------------------------------------------------------------------
Limitations
(total BHA
Food and BHT)
parts per
million
------------------------------------------------------------------------
Dehydrated potato shreds................................... 50
Dry breakfast cereals...................................... 50
Emulsion stabilizers for shortenings....................... 200
Potato flakes.............................................. 50
Potato granules............................................ 10
Sweetpotato flakes......................................... 50
------------------------------------------------------------------------
(c) To assure safe use of the additive:
(1) The label of any market package of the additive shall bear, in
addition to the other information required by the Act, the name of the
additive.
(2) When the additive is marketed in a suitable carrier, in addition
to meeting the requirement of paragraph (c)(1) of this section, the
label shall declare the percentage of the additive in the mixture.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.120]
[Page 33-34]
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 B--Food Preservatives
Sec. 172.120 Calcium disodium EDTA.
The food additive calcium disodium EDTA (calcium disodium ethylene-
diaminetetraacetate) may be safely used in designated foods for the
purposes and in accordance with the conditions prescribed, as follows:
(a) The additive contains a minimum of 99 percent by weight of
either the dihydrate
C10H12O8N2CaNa2[mi
ddot]2H2O or the trihydrate
C10H12O8N2CaNa2[mi
ddot]3H2O, or any mixture of the two.
(b) It is used or intended for use as follows:
(1) Alone, in the following foods at not to exceed the levels
prescribed, calculated as the anhydrous compound:
------------------------------------------------------------------------
Limitation
Food (parts per Use
million)
------------------------------------------------------------------------
Cabbage, pickled.................... 220 Promote color, flavor,
and texture
retention.
Canned carbonated soft drinks....... 33 Promote flavor
retention.
Canned white potatoes............... 110 Promote color
retention.
Clams (cooked canned)............... 340 Promote color
retention.
Crabmeat (cooked canned)............ 275 Retard struvite
formation; promote
color retention.
Cucumbers pickled................... 220 Promote color, flavor,
and texture
retention.
Distilled alcoholic beverages....... 25 Promote stability of
color, flavor, and/or
product clarity.
Dressings, nonstandardized.......... 75 Preservative.
Dried lima beans (cooked canned).... 310 Promote color
retention.
Egg product that is hard-cooked and \1\ 200 Preservative.
consists, in a cylindrical shape,
of egg white with an inner core of
egg yolk.
Fermented malt beverages............ 25 Antigushing agent.
French dressing..................... 75 Preservative.
Legumes (all cooked canned, other 365 Promote color
than dried lima beans, pink beans, retention.
and red beans).
Mayonnaise.......................... 75 Do.
Mushrooms (cooked canned)........... 200 Promote color
retention.
Oleomargarine....................... 75 Preservative.
Pecan pie filling................... 100 Promote color
retention.
Pink beans (cooked canned).......... 165 Promote color
retention.
Potato salad........................ 100 Preservative.
Processed dry pinto beans........... 800 Promote color
retention.
Red beans (cooked canned)........... 165 Promote color
retention.
Salad dressing...................... 75 Preservative.
Sandwich spread..................... 100 Do.
Sauces.............................. 75 Do.
Shrimp (cooked canned).............. 250 Retard struvite
formation; promote
color retention.
Spice extractives in soluble 60 Promote color and
carriers. flavor retention.
Spreads, artificially colored and 100 Promote color
lemon-flavored or orange-flavored. retention.
------------------------------------------------------------------------
\1\ By weight of egg yolk portion.
(2) With disodium EDTA (disodium ethylenediaminetetraacetate) in the
following foods at not to exceed, in combination, the levels prescribed,
calculated as anhydrous
C10H12O8N2CaNa2:
[[Page 34]]
------------------------------------------------------------------------
Limitation
Food (parts per Use
million)
------------------------------------------------------------------------
Dressings, nonstandardized.......... 75 Preservative.
French dressing..................... 75 Do.
Mayonnaise.......................... 75 Do.
Salad dressing...................... 75 Do.
Sandwich spread..................... 100 Do.
Sauces.............................. 75 Do.
------------------------------------------------------------------------
(c) To assure safe use of the additive:
(1) The label and labeling of the additive container shall bear, in
addition to the other information required by the Act, the name of the
additive.
(2) The label or labeling of the additive container shall bear
adequate use directions to provide a final food product that complies
with the limitations provided in paragraph (b) of this section.
(d) In the standardized foods listed in paragraph (b) of this
section, the additives are used only in compliance with the applicable
standards of identity for such foods.
[42 FR 14491, Mar. 15, 1977, as amended at 48 FR 10815, Mar. 15, 1983;
58 FR 52222, Oct. 7, 1993; 60 FR 33710, June 29, 1995; 65 FR 48379, Aug.
8, 2000]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.130]
[Page 34]
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 B--Food Preservatives
Sec. 172.130 Dehydroacetic acid.
The food additive dehydroacetic acid and/or its sodium salt may be
safely used in accordance with the following prescribed conditions:
(a) The food additive meets the following specifications:
Dehydroacetic acid: Melting point, 109 deg.C-111 deg.C; assay, minimum
98 percent (dry basis).
Sodium salt of dehydroacetic acid: Assay, minimum 98 percent (dry
basis).
(b) It is used or intended for use as a preservative for cut or
peeled squash, and is so used that no more than 65 parts per million
expressed as dehydroacetic acid remains in or on the prepared squash.
(c) The label or labeling of any package of the additive intended
for use in food shall bear adequate directions for use to insure
compliance with this section.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.133]
[Page 34-35]
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 B--Food Preservatives
Sec. 172.133 Dimethyl dicarbonate.
Dimethyl dicarbonate (CAS Reg. No. 4525-33-1) may be safely used in
food in accordance with the following prescribed conditions:
(a) The additive meets the following specifications:
(1) The additive has a purity of not less than 99.8 percent as
determined by the following titration method:
principles of method
Dimethyl dicarbonate (DMDC) is mixed with excess diisobutylamine
with which it reacts quantitatively. The excess amine is backtitrated
with acid.
apparatus
250-milliliter (mL) Beaker
100-mL Graduate cylinder
25-mL Pipette
10-mL Burette (automatic, eg., Metrohm burette)
Stirrer
Device for potentiometric titration
Reference electrode
Glass electrode
reagents
Acetone, analytical-grade
Solution of 1 N diisobutylamine in chlorobenzene, distilled
1 N Acetic Acid
procedure
Accurately weigh in about 2 grams of the sample (W) and dissolve in
100 mL acetone. Add accurately 25 mL of the 1 N diisobutylamine solution
by pipette and allow to stand for 5 minutes. Subsequently, titrate the
reaction mixture potentiometrically with 1 N hydrochloric acid
(consumption=a mL) while stirring. For determining the blank
consumption, carry out the analysis without a sample (consumption=b mL).
calculation
[GRAPHIC] [TIFF OMITTED] TR10MR99.023
Note: For adding the diisobutylamine solution, always use the same
pipette and wait for a further three drops to fall when the flow has
stopped.
(2) The additive contains not more than 2,000 ppm (0.2 percent)
dimethyl carbonate as determined by a method entitled "Gas
Chromatography Method for Dimethyl Carbonate Impurity in Dimethyl
Dicarbonate," whichis incorporated by reference in accordance with 5
U.S.C. 552(a). Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-200), 5100 Paint Branch Pkwy., College Park, MD
[[Page 35]]
20740, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(b) The additive is used or intended for use as a microbial control
agent in the following beverages under normal circumstances of bottling,
canning, or other forms of final packaging, where the viable microbial
load has been reduced to 500 microorganisms per milliliter or less by
current good manufacturing practices such as heat treatment, filtration,
or other technologies prior to the use of dimethyl dicarbonate:
(1) In wine, dealcoholized wine, and low alcohol wine in an amount
not to exceed 200 parts per million.
(2) In ready-to-drink teas in an amount not to exceed 250 parts per
million.
(3) In carbonated or noncarbonated, nonjuice-containing (less than
or equal to 1 percent juice), flavored or unflavored beverages
containing added electrolytes (5-20 milliequivalents/liter sodium ion
(Na+) and 3-7 milliequivalents/liter potassium ion (K+)) in an amount
not to exceed 250 parts per million.
(4) In carbonated, dilute beverages containing juice, fruit flavor,
or both, with juice content not to exceed 50 percent, in an amount not
to exceed 250 parts per million.
(c) To ensure the safe use of the food additive, the label of the
package containing the additive shall bear, in addition to other
information required by the Federal Food, Drug, and Cosmetic Act:
(1) The name of the additive "dimethyl dicarbonate."
(2) The intended use of the additive.
(3) Adequate directions for use to ensure compliance with this
section.
[53 FR 41329, Oct. 21, 1988, as amended at 58 FR 6091, Jan. 26, 1993; 59
FR 5319, Feb. 4, 1994; 61 FR 14245, Apr. 1, 1996; 61 FR 26788, May 29,
1996; 66 FR 13653, Mar. 7, 2001]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.135]
[Page 35-36]
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 B--Food Preservatives
Sec. 172.135 Disodium EDTA.
The food additive disodium EDTA (disodium
ethylenediaminetetraacetate) may be safely used in designated foods for
the purposes and in accordance with the following prescribed conditions:
(a) The additive contains a minimum of 99 percent disodium
ethylenedia-minetetraacetate dihydrate
(C10H14O8N2Na2[mid
dot]2H2O).
(b) It is used or intended for use as follows:
(1) Alone, in the following foods at not to exceed the levels
prescribed, calculated as anhydrous calcium disodium EDTA:
------------------------------------------------------------------------
Limitation
Food (parts per Use
million)
------------------------------------------------------------------------
Aqueous multivitamin preparations... 150 With iron salts as a
stabilizer for
vitamin B \12\ in
liquid multivitamin
preparations.
Canned black-eyed peas.............. 145 Promote color
retention.
Canned kidney beans................. 165 Preservative.
Canned strawberry pie filling....... 500 Promote color
retention.
Cooked sausage...................... 36 As a cure accelerator
with sodium ascorbate
or ascorbic acid.
Dressings, nonstandardized.......... 75 Preservative.
French dressing..................... 75 Do.
Frozen white potatoes including cut 100 Promote color
potatoes. retention.
Gefilte fish balls or patties in \1\ 50 Inhibit discoloration.
packing medium.
Legumes (all cooked canned, other 165 Promote color
than black-eyed peas). retention.
Mayonnaise.......................... 75 Preservative.
Ready-to-eat cereal products \2\ 315 Promote color
containing dried bananas. retention.
Salad dressing...................... 75 Preservative.
Sandwich spread..................... 100 Do.
Sauces.............................. 75 Do.
------------------------------------------------------------------------
\1\ Based on total weight of finished product including packing medium.
\2\ In dried banana component of cereal product.
(2) With calcium disodium EDTA (calcium disodium
ethylenediaminetetraacetate; calcium disodium (ethylenedinitrilo)
tetraacetate), in the following foods at not to exceed, in combination,
the levels prescribed, calculated as anhydrous
C10H12O8N2CaNa2:
------------------------------------------------------------------------
Limitation
Food (parts per Use
million)
------------------------------------------------------------------------
Dressings, nonstandardized.......... 75 Preservative.
French dressing..................... 75 Do.
Mayonnaise.......................... 75 Do.
Salad dressing...................... 75 Do.
Sandwich spread..................... 100 Do.
Sauces.............................. 75 Do.
------------------------------------------------------------------------
[[Page 36]]
(3) Alone, as a sequestrant in the nonnutritive sweeteners that are
listed in Sec. 180.37 of this chapter and that, in addition, are
designed for aqueous solution: Provided, That the amount of the
additive, calculated as anhydrous calcium disodium EDTA, does not exceed
0.1 percent by weight of the dry nonnutritive sweetener.
(c) To assure the safe use of the additive:
(1) The label and labeling of the additive container shall bear, in
addition to the other information required by the act, the name of the
additive.
(2) The label or labeling of the additive container shall bear
adequate use directions to provide a final food product that complies
with the limitations provided in paragraph (b) of this section.
(d) In the standardized foods listed in paragraphs (b) (1) and (2)
of this section the additives are used only in compliance with the
applicable standards of identity for such foods.
[42 FR 14491, Mar. 15, 1977, as amended at 65 FR 48379, Aug. 8, 2000]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.140]
[Page 36]
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 B--Food Preservatives
Sec. 172.140 Ethoxyquin.
(a) Ethoxyquin (1,2-dihydro-6-ethoxy-2,2,4-trimethylquinoline) may
be safely used as an antioxidant for preservation of color in the
production of chili powder, paprika, and ground chili at levels not in
excess of 100 parts per million.
(b) In order to provide for the safe use of the additive in feed
prepared in accordance with Secs. 573.380 and 573.400 of this chapter,
tolerances are established for residues of ethoxyquin in or on edible
products of animals as follows:
5 parts per million in or on the uncooked fat of meat from animals
except poultry.
3 parts per million in or on the uncooked liver and fat of poultry.
0.5 part per million in or on the uncooked muscle meat of animals.
0.5 part per million in poultry eggs.
Zero in milk.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.145]
[Page 36]
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 B--Food Preservatives
Sec. 172.145 Heptylparaben.
(a) The food additive heptylparaben is the chemical n-heptyl p-
hydroxybenzoate.
(b) It may be safely used to inhibit microbiological spoilage in
accordance with the following prescribed conditions:
(1) In fermented malt beverages in amounts not to exceed 12 parts
per million.
(2) In noncarbonated soft drinks and fruit-based beverages in
amounts not to exceed 20 parts per million, when standards of identity
established under section 401 of the Act (21 U.S.C. 341) do not preclude
such use.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.150]
[Page 36]
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 B--Food Preservatives
Sec. 172.150 4-Hydroxymethyl-2,6-di-tert-butylphenol.
The food additive 4-hydroxymethyl-2,6-di-tert-butylphenol may be
safely used in food in accordance with the following prescribed
conditions:
(a) The additive has a solidification point of 140 deg.C-141
deg.C.
(b) The additive is used as an antioxidant alone or in combination
with other permitted antioxidants.
(c) The total amount of all antioxidants added to such food shall
not exceed 0.02 percent of the oil or fat content of the food, including
the essential (volatile) oil content of the food.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.155]
[Page 36-37]
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 B--Food Preservatives
Sec. 172.155 Natamycin (pimaricin).
(a) Natamycin (CAS Reg. No. 7681-93-8), also known as pimaricin, is
a polyene macrolide antimycotic substance possessing an empirical
formula of C33H47NO13 and a molecular
weight of 665.7.
(b) The additive shall conform to the following specifications:
Purity: 97 percent 2 percent on an anhydrous basis.
Arsenic: Not more than 1 part per million.
Heavy metals (as Pb): Not more than 20 parts per million.
(c) The additive may be applied on cheese, as an antimycotic, in
amounts not to exceed 20 milligrams per kilogram (20 parts per million)
in the finished product as determined by International Dairy Federation
(IDF) Standard 140A:1992, "Cheese and Cheese Rind-Determination of
Natamycin Content-Method by Molecular Absorption Spectrometry and by
High-Performance Liquid Chromatography," 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. Copies are available from the Division of Product
[[Page 37]]
Policy (HFS-206), Center for Food Safety and Applied Nutrition, Food and
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
may be examined at the Center for Food Safety and Applied Nutrition's
Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the
Office of the Federal Register, 800 North Capitol St. NW., suite 700,
Washington, DC.
[47 FR 26823, June 22, 1982, as amended at 50 FR 49536, Dec. 3, 1985; 63
FR 66015, Dec. 1, 1998; 66 FR 13847, Mar. 8, 2001]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.160]
[Page 37]
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 B--Food Preservatives
Sec. 172.160 Potassium nitrate.
The food additive potassium nitrate may be safely used as a curing
agent in the processing of cod roe, in an amount not to exceed 200 parts
per million of the finished roe.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.165]
[Page 37]
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 B--Food Preservatives
Sec. 172.165 Quaternary ammonium chloride combination.
The food additive, quaternary ammonium chloride combination, may be
safely used in food in accordance with the following conditions:
(a) The additive contains the following compounds: n-dodecyl
dimethyl benzyl ammonium chloride (CAS Reg. No. 139-07-1); n-dodecyl
dimethyl ethylbenzyl ammonium chloride (CAS Reg. No. 27479-28-3); n-
hexadecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 122-18-9); n-
octadecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 122-19-0); n-
tetradecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 139-08-2); n-
tetradecyl dimethyl ethylbenzyl ammonium chloride (CAS Reg. No. 27479-
29-4).
(b) The additive meets the following specifications: pH (5 percent
active solution) 7.0-8.0; total amines, maximum 1 percent as combined
free amines and amine hydrochlorides.
(c) The additive is used as an antimicrobial agent, as defined in
Sec. 170.3(o)(2) of this chapter, in raw sugar cane juice. It is added
prior to clarification when further processing of the sugar cane juice
must be delayed.
(d) The additive is applied to the sugar juice in the following
quantities, based on the weight of the raw cane:
------------------------------------------------------------------------
Parts per
Component million
------------------------------------------------------------------------
n-Dodecyl dimethyl benzyl ammonium chloride................ 0.25-1.0
n-Dodecyl dimethyl ethylbenzyl ammonium chloride........... 3.4-13.5
n-Hexadecyl dimethyl benzyl ammonium chloride.............. 1.5-6.0
n-Octadecyl dimethyl benzyl ammonium chloride.............. 0.25-1.0
n-Tetradecyl dimethyl benzyl ammonium chloride............. 3.0-12.0
n-Tetradecyl dimethyl ethylbenzyl ammonium chloride........ 1.6-6.5
------------------------------------------------------------------------
[50 FR 3890, Jan. 29, 1985]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.170]
[Page 37-38]
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 B--Food Preservatives
Sec. 172.170 Sodium nitrate.
The food additive sodium nitrate may be safely used in or on
specified foods in accordance with the following prescribed conditions:
(a) It is used or intended for use as follows:
(1) As a preservative and color fixative, with or without sodium
nitrite, in smoked, cured sablefish, smoked, cured salmon, and smoked,
cured shad, so that the level of sodium nitrate does not exceed 500
parts per million and the level of sodium nitrite does not exceed 200
parts per million in the finished product.
(2) As a preservative and color fixative, with or without sodium
nitrite, in meat-curing preparations for the home curing of meat and
meat products (including poultry and wild game), with directions for use
which limit the amount of sodium nitrate to not more than 500 parts per
million in the finished meat product and the amount of sodium nitrite to
not more than 200 parts per million in the finished meat product.
(b) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of the additive or of a mixture containing the
additive shall bear:
(i) The name of the additive.
(ii) A statement of the concentration of the additive in any
mixture.
(2) If in a retail package intended for household use, the label and
labeling of the additive, or of a mixture containing the additive, shall
bear adequate directions for use to provide a final food product that
complies with the limitations prescribed in paragraph (a) of this
section.
[[Page 38]]
(3) If in a retail package intended for household use, the label of
the additive or of a mixture containing the additive, shall bear the
statement "Keep out of the reach of children".
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.175]
[Page 38]
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 B--Food Preservatives
Sec. 172.175 Sodium nitrite.
The food additive sodium nitrite may be safely used in or on
specified foods in accordance with the following prescribed conditions:
(a) It is used or intended for use as follows:
(1) As a color fixative in smoked cured tunafish products so that
the level of sodium nitrite does not exceed 10 parts per million (0.001
percent) in the finished product.
(2) As a preservative and color fixative, with or without sodium
nitrate, in smoked, cured sablefish, smoked, cured salmon, and smoked,
cured shad so that the level of sodium nitrite does not exceed 200 parts
per million and the level of sodium nitrate does not exceed 500 parts
per million in the finished product.
(3) As a preservative and color fixative, with sodium nitrate, in
meat-curing preparations for the home curing of meat and meat products
(including poultry and wild game), with directions for use which limit
the amount of sodium nitrite to not more than 200 parts per million in
the finished meat product, and the amount of sodium nitrate to not more
than 500 parts per million in the finished meat product.
(b) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of the additive or of a mixture containing the
additive shall bear:
(i) The name of the additive.
(ii) A statement of the concentration of the additive in any
mixture.
(2) If in a retail package intended for household use, the label and
labeling of the additive, or of a mixture containing the additive, shall
bear adequate directions for use to provide a final food product which
complies with the limitations prescribed in paragraph (a) of this
section.
(3) If in a retail package intended for household use, the label of
the additive, or of a mixture containing the additive, shall bear the
statement "Keep out of the reach of children".
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.177]
[Page 38-39]
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 B--Food Preservatives
Sec. 172.177 Sodium nitrite used in processing smoked chub.
The food additive sodium nitrite may be safely used in combination
with salt (NaCl) to aid in inhibiting the outgrowth and toxin formation
from Clostridium botulinum type E in the commercial processing of smoked
chub in accordance with the following prescribed conditions:
(a) All fish in smoking establishments shall be clean and wholesome
and shall be expeditiously processed, packed, and stored under adequate
sanitary conditions in accordance with good manufacturing practice.
(b) The brining procedure is controlled in such a manner that the
water phase portion of the edible portion of the finished smoked product
has a salt (NaCl) content of not less than 3.5 percent, as measured in
the loin muscle, and the sodium nitrite content of the edible portion of
the finished smoked product is not less than 100 parts per million and
not greater than 200 parts per million, as measured in the loin muscle.
(c) Smoked chub shall be heated by a controlled heat process which
provides a monitoring system positioned in as many strategic locations
in the smokehouse as necessary to assure a continuous temperature
throughout each fish of at least 160 deg.F for a minimum of 30 minutes.
(d) The finished product shall be cooled to a temperature of 50
deg.F or below within 3 hours after smoking and further cooled to a
temperature of 38 deg.F or below within 12 hours after smoking. A
temperature of 38 deg.F or below shall be maintained during all
subsequent storage and distribution. All shipping containers, retail
packages, and shipping records shall indicate with appropriate notice
the perishable nature of the product and specify that the product shall
be held under refrigeration (38 deg.F or below) until consumed.
(e) To assure safe use of the additive:
(1) The label and labeling of the additive container shall bear, in
addition to the other information required by the Act, the name of the
additive.
[[Page 39]]
(2) The label or labeling of the additive container shall bear
adequate directions to assure use in compliance with the provisions of
this section.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.180]
[Page 39]
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 B--Food Preservatives
Sec. 172.180 Stannous chloride.
The food additive stannous chloride may be safely used for color
retention in asparagus packed in glass, with lids lined with an inert
material, in an amount not to exceed 20 parts per million calculated as
tin (Sn).
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.185]
[Page 39]
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 B--Food Preservatives
Sec. 172.185 TBHQ.
The food additive TBHQ, which is the chemical 2-(1,1-dimethylethyl)-
1,4-benzenediol (Chemical Abstracts Service Registry Number 1948-33-0),
also known as tertiary butylhydroquinone, may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive has a melting point of 126.5 deg.C-128.5
deg.C.
(b) It is used as an antioxidant alone or in combination with BHA
and/or BHT.
(c) The total antioxidant content of a food containing the additive
will not exceed 0.02 percent of the oil or fat content of the food,
including the essential (volatile) oil content of the food.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.190]
[Page 39]
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 B--Food Preservatives
Sec. 172.190 THBP.
The food additive THBP (2,4,5-trihydroxybutyrophenone) may be safely
used in food in accordance with the following prescribed conditions:
(a) The food additive has a melting point of 149 deg.C-153 deg.C.
(b) It is used as an antioxidant alone or in combination with other
permitted antioxidants.
(c) The total antioxidant content of a food containing the additive
will not exceed 0.02 percent of the oil or fat content of the food,
including the essential (volatile) oil content of the food.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.210]
[Page 39-40]
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 C--Coatings, Films and Related Substances
Sec. 172.210 Coatings on fresh citrus fruit.
Coatings may be applied to fresh citrus fruit for protection of the
fruit in accordance with the following conditions:
(a) The coating is applied in the minimum amount required to
accomplish the intended effect.
(b) The coating may be formulated from the following components,
each used in the minimum quantity required to accomplish the intended
effect:
(1) Substances generally recognized as safe for the purpose or
previously sanctioned for the purpose.
(2) One or more of the following:
------------------------------------------------------------------------
Component Limitations
------------------------------------------------------------------------
Fatty acids.................... Complying with Sec. 172.860.
Oleic acid derived from tall Complying with Sec. 172.862.
oil fatty acids.
Partially hydrogenated rosin... Catalytically hydrogenated to a maximum
refractive index of 1.5012 at 100
deg.C. Color of WG or paler.
Pentaerythritol ester of maleic Acid number of 134-145; drop-softening
anhydride-modified wood rosin. point of 127 deg.C-173 deg.C;
saponification number of less than
280; and a color of M or paler.
Do......................... Acid number of 176-186; drop-softening
point of 110 deg.C-118 deg.C;
saponification number of less than
280; and a color of M or paler.
Polyethylene glycol............ Complying with Sec. 172.820. As a
defoamer and dispersing adjuvant.
Polyhydric alcohol diesters of Complying with Sec. 178.3770 of this
oxidatively refined chapter and having a dropping point of
(Gersthofen process) montan 77 to 83 deg.C (170.6 to 181.4
wax acids. deg.F), as determined by ASTM Method
D566-76 (Reapproved 1982), "Standard
Test Method for Dropping Point of
Lubricating Grease," which is
incorporated by reference (copies are
available from the American Society
for Testing and Materials, 1916 Race
St., Philadelphia, PA 19103, or
available for inspection at the Office
of the Federal Register, 800 North
Capitol Street, NW., suite 700,
Washington, DC 20408) using as a
solvent xylene-ethyl alcohol in a 2:1
ratio instead of toluene-ethyl alcohol
in a 2:1 ratio.
Sodium lauryl sulfate.......... Complying with Sec. 172.822. As a film
former.
Wood rosin..................... Color of K or paler.
------------------------------------------------------------------------
(3) In lieu of the components listed in paragraph (b) (2) and (4) of
this section, the following copolymer and one or more of the listed
adjuvants.
[[Page 40]]
------------------------------------------------------------------------
Component Limitations
------------------------------------------------------------------------
Vinyl chloride-vinylidene As an aqueous dispersion containing a
chloride copolymer. minimum of 75 percent water when
applied.
Polyethylene glycol............ Complying with Sec. 172.820. As a
defoamer and dispersing adjuvant.
Polyvinylpyrrolidone........... As an adjuvant.
Potassium persulfate........... Do.
Propylene glycol alginate...... Do.
Sodium decylbenzenesulfonate... Do.
------------------------------------------------------------------------
(4) In lieu of the components listed in paragraph (b) (2) and (3) of
this section, the following rosin derivative and either or both of the
listed adjuvants:
------------------------------------------------------------------------
Component Limitations
------------------------------------------------------------------------
Calcium salt of partially Having a maximum drop-softening point
dimerized rosin. of 197 deg.C and a color of H or
paler. It is prepared by reaction with
not more than 7 parts hydrated lime
per 100 parts of partially dimerized
rosin. The partially dimerized rosin
is rosin that has been dimerized by
sulfuric acid catalyst to a drop-
softening point of 95 deg.C to 105
deg.C and a color of WG or paler.
Petroleum naphtha.............. As adjuvant. Complying with Sec.
172.250.
Sperm oil...................... As adjuvant.
------------------------------------------------------------------------
[42 FR 14491, Mar. 15, 1977; 49 FR 5747, Feb. 15, 1984, as amended at 51
FR 2693, Jan. 21, 1986; 52 FR 18911, May 20, 1987; 61 FR 14245, Apr. 1,
1996]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.215]
[Page 40]
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 C--Coatings, Films and Related Substances
Sec. 172.215 Coumarone-indene resin.
The food additive coumarone-indene resin may be safely used on
grapefruit, lemons, limes, oranges, tangelos, and tangerines in
accordance with the following prescribed conditions:
(a) The food additive is manufactured by the polymerization of a
crude, heavy coal-tar solvent naphtha meeting the following
specifications:
(1) It is a mixture of indene, indan (hydrindene), substituted
benzenes, and related compounds.
(2) It contains no more than 0.25 percent tar bases.
(3) 95 percent distills in the range 167 deg.C-184 deg.C.
(b) The food additive meets the following specifications:
(1) Softening point, ring and ball: 126 deg.C minimum as determined
by ASTM method E28-67 (Reapproved 1982), "Standard Test Method for
Softening Point by Ring-and-Ball Apparatus," which is incorporated by
reference. Copies may be obtained from the American Society for Testing
Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at
the Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(2) Refractive index (n\25\/D) 1.63-1.64.
(c) It is used or intended for use as a protective coating for
grapefruit, lemons, limes, oranges, tangelos, and tangerines whereby the
maximum amount of the resin remaining on the fruit does not exceed 200
parts per million on a fresh-weight basis.
(d) To assure safe use of the additive:
(1) The label of the market package or any intermediate premix of
the additive shall bear, in addition to the other information required
by the act:
(i) The name of the additive, coumarone-indene resin.
(ii) A statement of the concentration of the additive therein.
(2) The label or accompanying labeling shall bear adequate
directions that, if followed, will result in a finished food not in
conflict with the requirements of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10103, Mar. 19, 1984]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.225]
[Page 40-41]
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 C--Coatings, Films and Related Substances
Sec. 172.225 Methyl and ethyl esters of fatty acids produced from edible fats and oils.
Methyl esters and ethyl esters of fatty acids produced from edible
fats and oils may be safely used in food, subject to the following
prescribed conditions:
(a) The additive consists of a mixture of either methyl or ethyl
esters of fatty acids produced from edible fats and oils and meets the
following specifications:
(1) Not less than 90 percent methyl or ethyl esters of fatty acids.
[[Page 41]]
(2) Not more than 1.5 percent unsaponifiable matter.
(b) The additive is used or intended for use at the level not to
exceed 3 percent by weight in an aqueous emulsion in dehydrating grapes
to produce raisins, whereby the residue of the additive on the raisins
does not exceed 200 parts per million.
[57 FR 12711, Apr. 13, 1992]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.230]
[Page 41]
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 C--Coatings, Films and Related Substances
Sec. 172.230 Microcapsules for flavoring substances.
Microcapsules may be safely used for encapsulating discrete
particles of flavoring substances that are generally recognized as safe
for their intended use or are regulated under this part, in accordance
with the following conditions:
(a) The microcapsules may be formulated from the following
components, each used in the minimum quantity required to accomplish the
intended effect:
(1) Substances generally recognized as safe for the purpose.
(2) One or more of the following components:
component and limitations
Succinylated gelatin--Not to exceed 15 percent by combined weight of the
microcapsule and flavoring oil. Succinic acid content of the gelatin is
4.5 to 5.5 percent.
Arabinogalactan--Complying with Sec. 172.610; as adjuvant.
Silicon dioxide--Complying with Sec. 172.480; as adjuvant.
(3) In lieu of the components listed in paragraph (a)(2) of this
section, the following components:
component and limitations
Glutaraldehyde--As cross-linking agent for insolubilizing a coacervate
of gum arabic and gelatin.
n-Octyl alcohol--As a defoamer.
(4) In lieu of the components listed in paragraphs (a)(2) and (3) of
this section, the following component:
component and limitations
Petroleum wax--Complying with Sec. 172.886. Not to exceed 50 percent by
combined weight of the microcapsule and spice-flavoring substance.
(b) The microcapsules produced from the components listed in
paragraphs (a) (1), (2), and (3) of this section may be used for
encapsulating authorized flavoring oils for use, in accordance with good
manufacturing practice, in foods for which standards of identity
established under section 401 of the Act do not preclude such use,
except that microcapsules formulated from components listed in paragraph
(a)(2) of this section may be used only for encapsulating lemon oil,
distilled lime oil, orange oil, peppermint oil, and spearmint oil for
use in dry mixes for puddings and gelatin desserts.
(c) The microcapsules produced from the components listed in
paragraphs (a) (1) and (4) of this section may be used only for
encapsulating authorized spice-flavoring substances for use, in
accordance with good manufacturing practice, in frozen pizzas which are
to be further processed by heat. Such pizzas shall bear labels or
labeling including adequate directions for use to ensure heating to
temperatures which will melt the wax to release the spice-flavoring
substances.
[45 FR 48123, July 18, 1980]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.235]
[Page 41]
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 C--Coatings, Films and Related Substances
Sec. 172.235 Morpholine.
Morpholine may be safely used as a component of food, subject to the
following restrictions.
(a) It is used as the salt(s) of one or more of the fatty acids
meeting the requirements of Sec. 172.860, as a component of protective
coatings applied to fresh fruits and vegetables.
(b) It is used at a level not in excess of that reasonably required
to produce its intended effect.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.250]
[Page 41-44]
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 C--Coatings, Films and Related Substances
Sec. 172.250 Petroleum naphtha.
Petroleum naphtha may be safely used in food in accordance with the
following conditions:
(a) The additive is a mixture of liquid hydrocarbons, essentially
paraffinic and naphthenic in nature obtained from petroleum,
(b) The additive is refined to meet the following specifications
when subjected to the procedures described in this paragraph.
(1) Boiling-point range: 175 deg.F-300 deg.F.
(2) Nonvolatile residue: 0.002 gram per 100 milliliters maximum.
[[Page 42]]
(3) Ultraviolet absorbance limits, as follows:
------------------------------------------------------------------------
Maximum
absorbance
per
Wavelength (milli-microns) centimeter
optical
pathlength
------------------------------------------------------------------------
280-289..................................................... 0.15
290-299..................................................... .13
300-359..................................................... .08
360-400..................................................... .02
------------------------------------------------------------------------
Analytical Specification for Petroleum Naphtha
general instructions
All glassware should be scrupulously cleaned to remove all organic
matter such as oil, grease, detergent residues, etc. Examine all
glassware, including stoppers and stopcocks, under ultraviolet light to
detect any residual fluorescent contamination. As a precautionary
measure, it is recommended practice to rinse all glassware with purified
isooctane immediately before use. No grease is to be used on stopcocks
or joints. Great care to avoid contamination of petroleum naphtha
samples in handling and to assure absence of any extraneous material
arising from inadequate packaging is essential. Because some of the
polynuclear hydrocarbons sought in this test are very susceptible to
photo-oxidation, the entire procedure is to be carried out under subdued
light.
apparatus
Separatory funnels. 250-milliliter, and 2,000-milliliter capacity,
equipped with tetrafluoroethylene polymer stopcocks.
Erlenmeyer flask. 125-milliliter with 24/40 standard taper neck.
Evaporation flask. 250-milliliter capacity all-glass flask equipped
with 24/40 standard taper stopper having inlet and outlet tubes to
permit passage of nitrogen across the surface of the container liquid to
be evaporated.
Condenser. 24/40 joints, fitted with drying tube, length optional.
Spectrophotometric cells. Fused quartz cells, optical path length in
the range of 5,000 centimeters 0.005 centimeter; also for
checking spectrophotometer performance only, optical path length in the
range 1,000 centimeter 0.005 centimeter. With distilled
water in the cells, determine any absorbance difference.
Spectrophotometer. Spectral range 250-400 m[mu] with spectral slit
width of 2 m[mu] or less; under instrument operating conditions for
these absorbance measurements, the spectrophotometer shall also meet the
following performance requirements:
Absorbance repeatability, 0.01 at 0.4 absorbance.
Absorbance accuracy, \1\ 0.05 at 0.4 absorbance.
---------------------------------------------------------------------------
\1\ As determined by procedure using potassium chromate for
reference standard and described in National Bureau of Standards
Circular 484, Spectrophotometry, U.S. Department of Commerce, (1949).
The accuracy is to be determined by comparison with the standard values
at 290, 345, and 400 millimicrons. The procedure is incorporated by
reference. Copies of the material incorporated by reference are
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
---------------------------------------------------------------------------
Wavelength repeatability, 0.2 millimicron.
Wavelength accuracy, 1.0 millimicron.
Ultraviolet lamp. Long wavelength (3400-3800A deg.).
reagents
Isooctane (2,2,4-trimethylpentane). Use 180 milliliters in a 250-
milliliter Erlenmeyer flask, add 1 milliliter of purified n-hexadecane,
insert the head assembly, allow nitrogen gas to flow into the inlet tube
and connect the outlet tube to a solvent trap and vacuum line in such a
way as to prevent any back flow of condensate into the flask. The
contents of the flask are evaporated on a steam bath until 1 milliliter
of residue remains. Dissolve the 1 milliliter of hexadecane residue in
isooctane and make up to 25 milliliters. Determine the absorbance in a
5-centimeter path length cell compared to isooctane as reference. The
absorbance should not exceed 0.01 per centimeter path length between
280-400 m[mu]. If necessary, isooctane may be purified by passage
through a column of activated silica gel (Grade 12, Davidson Chemical
Co., Baltimore, Md., or equivalent) or by distillation.
Methyl alcohol, A.C.S. reagent grade. Use 10 milliliters and proceed
as with isooctane. The absorbance per centimeter of path length should
be 0.00 between 280-400 m[mu]. Methyl alcohol may be purified by simple
distillation or by refluxing in the presence of potassium hydroxide (10
grams/2 liters) and zinc dust (25 grams/2 liters) for 3 hours followed
by distillation.
n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 25 milliliters with isooctane and determine the absorbance
in a 5-centimeter cell compared to isooctane as reference between 280-
400 m[mu]. The absorbance per centimeter path length shall not exceed
0.00 in this range. Purify, if necessary, by percolation through
activated silica gel or by distillation.
Sodium borohydride. 98 percent.
[[Page 43]]
Water. All distilled water must be extracted with isooctane before
use. A series of three successive extracts of 1.5 liters of distilled
water with 100-milliliter portions of isooctane is satisfactory.
procedure
Determination of ultraviolet absorbance. Add a 25-milliliter aliquot
of the hydrocarbon solvent together with 1 milliliter of hexadecane to
the 125-milliliter Erlenmeyer flask. While flushing with nitrogen,
evaporate to 1 milliliter on a steam bath. Nitrogen is admitted through
a 81-milliliter outer-diameter tube, drawn out into a
21-centimeter long and 10.5-millimeter inner-
diameter capillary tip. This is positioned so that the capillary tip
extends 4 centimeters into the flask. The nitrogen flow rate is such
that the surface of the liquid is barely disturbed. After the volume is
reduced to that of the 1 milliliter of hexadecane, the flask is left on
the steam bath for 10 more minutes before removing. Add 10 milliliters
of purified isooctane to the flask and reevaporate the solution to a 1-
milliliter volume in the same manner as described above, except do not
heat for an added 10 minutes. Repeat this operation twice more. Let the
flask cool.
Add 10 milliliters of methyl alcohol and about 0.3 gram of sodium
borohydride. (Minimize exposure of the borohydride to the atmosphere; a
measuring dipper may be used.) Immediately fit a water-cooled condenser
equipped with a 24/40 joint and with a drying tube into the flask, mix
until the sodium borohydride is dissolved, and allow to stand for 30
minutes at room temperature, with intermittent swirling. At the end of
this time, disconnect the flask and evaporate the methyl alcohol on the
steam bath under nitrogen until sodium borohydride begins to drop out of
solution. Remove the flask and let it cool.
Add 6 milliliters of isooctane to the flask and swirl to wash the
crystalline slurry. Carefully transfer the isooctane extract to a 250-
milliliter separatory funnel. Dissolve the crystals in the flask with
about 25 milliliters of distilled water and pour this also into the
separatory funnel. Adjust the water volume in the separatory funnel to
about 100 milliliters and shake for 1 minute. After separation of the
layers, draw off the aqueous layer into a second 250-milliliter
separatory funnel. Transfer the hydrocarbon layer in the first funnel to
a 25-milliliter volumetric flask.
Carefully wash the Erlenmeyer flask with an additional 6 milliliters
of isooctane, swirl, and transfer to the second separatory funnel. Shake
the funnel for 1 minute. After separation of the layers, draw off the
aqueous layer into the first separatory funnel. Transfer the isooctane
in the second funnel to the volumetric flask. Again wash the Erlenmeyer
flask with an additional 6 milliliters of isooctane, swirl, and transfer
to the first separatory funnel. Shake the funnel for 1 minute. After
separation of the layers, draw off the aqueous layer and discard.
Transfer the isooctane layer to the volumetric flask and adjust the
volume to 25 milliliters of isooctane. Mix the contents well, then
transfer to the first separatory funnel and wash twice with 50-
milliliter portions of distilled water. Discard the aqueous layers after
each wash.
Determine the ultraviolet absorbance of the isooctane extract in 5-
centimeter path length cells compared to isooctane as reference between
280-400 m[mu]. Determine a reagent blank concurrently with the sample,
using 25 milliliters of purified isooctane instead of a solvent sample
and measuring the ultraviolet absorbance of the blank between 280-
400m[mu].
The reagent blank absorbance should not exceed 0.04 per centimeter
path length between 280-289 m[mu]; 0.020 between 290-359 m[mu]; and
0.010 between 360-400 m[mu].
Determination of boiling-point range. Use ASTM method D86-82,
"Standard Method for Distillation of Petroleum Products," which is
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
Determination of nonvolatile residue. For hydrocarbons boiling below
121 deg.C, determine the nonvolatile residue by ASTM method D1353-78,
"Standard Test Method for Nonvolatile Matter in Volatile Solvents for
Use in Paint, Varnish, Lacquer, and Related Products;" for those
boiling above 121 deg.C, use ASTM method D381-80, "Standard Test
Method for Existent Gum in Fuels by Jet Evaporation," which methods are
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(c) Petroleum naphtha containing antioxidants shall meet the
specified ultraviolet absorbance limits after correction for any
absorbance due to the antioxidants. Petroleum naphtha may contain
antioxidants authorized for use in food in an amount not to exceed that
reasonably required to accomplish the intended effect or to exceed any
prescribed limitations.
[[Page 44]]
(d) Petroleum naphtha is used or intended for use as a solvent in
protective coatings on fresh citrus fruit in compliance with
Sec. 172.210.
[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11835, Mar. 19, 1982;
49 FR 10104, Mar. 19, 1984; 54 FR 24896, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.255]
[Page 44]
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 C--Coatings, Films and Related Substances
Sec. 172.255 Polyacrylamide.
Polyacrylamide containing not more than 0.2 percent of acrylamide
monomer may be safely used as a film former in the imprinting of soft-
shell gelatin capsules when the amount used is not in excess of the
minimum required to produce the intended effect.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.260]
[Page 44]
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 C--Coatings, Films and Related Substances
Sec. 172.260 Oxidized polyethylene.
Oxidized polyethylene may be safely used as a component of food,
subject to the following restrictions:
(a) Oxidized polyethylene is the basic resin produced by the mild
air oxidation of polyethylene. The polyethylene used in the oxidation
process conforms to the density, maximum n-hexane extractable fraction,
and maximum xylene soluble fraction specifications prescribed in item
2.3 of the table in Sec. 177.1520(c) of this chapter. The oxidized
polyethylene has a minimum number average molecular weight of 1,200, as
determined by high temperature vapor pressure osmometry; contains a
maximum of 5 percent by weight of total oxygen; and has an acid value of
9 to 19.
(b) The additive is used or intended for use as a protective coating
or component of protective coatings for fresh avocados, bananas, beets,
coconuts, eggplant, garlic, grapefruit, lemons, limes, mango,
muskmelons, onions, oranges, papaya, peas (in pods), pineapple,
plantain, pumpkin, rutabaga, squash (acorn), sweetpotatoes, tangerines,
turnips, watermelon, Brazil nuts, chestnuts, filberts, hazelnuts,
pecans, and walnuts (all nuts in shells).
(c) The additive is used in accordance with good manufacturing
practice and in an amount not to exceed that required to produce the
intended effect.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.270]
[Page 44]
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 C--Coatings, Films and Related Substances
Sec. 172.270 Sulfated butyl oleate.
Sulfate butyl oleate may be safely used in food, subject to the
following prescribed conditions:
(a) The additive is prepared by sulfation, using concentrated
sulfuric acid, of a mixture of butyl esters produced by
transesterification of an edible vegetable oil using 1-butanol.
Following sulfation, the reaction mixture is washed with water and
neutralized with aqueous sodium or potassium hydroxide. Prior to
sulfation, the butyl oleate reaction mixture meets the following
specifications:
(1) Not less than 90 percent butyl oleate.
(2) Not more than 1.5 percent unsaponifiable matter.
(b) The additive is used or intended for use at a level not to
exceed 2 percent by weight in an aqueous emulsion in dehydrating grapes
to produce raisins, whereby the residue of the additive on the raisins
does not exceed 100 parts per million.
[57 FR 12711, Apr. 13, 1992]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.275]
[Page 44-45]
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 C--Coatings, Films and Related Substances
Sec. 172.275 Synthetic paraffin and succinic derivatives.
Synthetic paraffin and succinic derivatives identified in this
section may be safely used as a component of food, subject to the
following restrictions:
(a) The additive is prepared with 50 percent Fischer-Tropsch process
synthetic paraffin, meeting the definition and specifications of
Sec. 172.615, and 50 percent of such synthetic paraffin to which is
bonded succinic anhydride and succinic acid derivatives of isopropyl
alcohol, polyethylene glycol, and polypropylene glycol. It consists of a
mixture of the Fischer-Tropsch process paraffin (alkane), alkyl succinic
anhydride, alkyl succinic anhydride isopropyl half ester, dialkyl
succinic anhydride polyethylene glycol half ester, and dialkyl succinic
anhydride polypropylene glycol half ester, where the alkane (alkyl) has
a chain length of 30-70 carbon atoms and the polyethylene and
polypropylene glycols have molecular weights of 600 and 260,
respectively.
(b) The additive meets the following specifications: Molecular
weight, 880-930; melting point, 215 deg.-217 deg.F; acid number, 43-47;
and saponification number, 75-78.
(c) It is used or intended for use as a protective coating or
component of
[[Page 45]]
protective coatings for fresh grapefruit, lemons, limes, muskmelons,
oranges, sweetpotatoes, and tangerines.
(d) It is used in an amount not to exceed that required to produce
the intended effect.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.280]
[Page 45]
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 C--Coatings, Films and Related Substances
Sec. 172.280 Terpene resin.
The food additive terpene resin may be safely used in accordance
with the following prescribed conditions:
(a) The food additive is the betapinene polymer obtained by
polymerizing terpene hydrocarbons derived from wood. It has a softening
point of 112 deg.C-118 deg.C, as determined by ASTM method E28-67
(Reapproved 1982), "Standard Test Method for Softening Point By Ring-
and-Ball Apparatus," which is incorporated by reference. Copies may be
obtained from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(b) It is used or intended for use as follows:
(1) As a moisture barrier on soft gelatin capsules in an amount not
to exceed 0.07 percent of the weight of the capsule.
(2) As a moisture barrier on powders of ascorbic acid or its salts
in an amount not to exceed 7 percent of the weight of the powder.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10104, Mar. 19, 1984]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.310]
[Page 45]
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 D--Special Dietary and Nutritional Additives
Sec. 172.310 Aluminum nicotinate.
Aluminum nicotinate may be safely used as a source of niacin in
foods for special dietary use. A statement of the concentration of the
additive, expressed as niacin, shall appear on the label of the food
additive container or on that of any intermediate premix prepared
therefrom.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.315]
[Page 45]
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 D--Special Dietary and Nutritional Additives
Sec. 172.315 Nicotinamide-ascorbic acid complex.
Nicotinamide-ascorbic acid complex may be safely used in accordance
with the following prescribed conditions:
(a) The additive is the product of the controlled reaction between
ascorbic acid and nicotinamide, melting in the range 141 deg.C to 145
deg.C.
(b) It is used as a source of ascorbic acid and nicotinamide in
multivitamin preparations.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.320]
[Page 45-47]
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 D--Special Dietary and Nutritional Additives
Sec. 172.320 Amino acids.
The food additive amino acids may be safely used as nutrients added
to foods in accordance with the following conditions:
(a) The food additive consists of one or more of the following
individual amino acids in the free, hydrated or anhydrous form or as the
hydrochloride, sodium or potassium salts:
L-Alanine
L-Arginine
L-Asparagine
L-Aspartic acid
L-Cysteine
L-Cystine
L-Glutamic acid
L-Glutamine
Aminoacetic acid (glycine)
L-Histidine
L-Isoleucine
L-Leucine
L-Lysine
DL-Methionine (not for infant foods)
L-Methionine
L-Phenylalanine
L-Proline
L-Serine
L-Threonine
L-Tryptophan
L-Tyrosine
L-Valine
(b) The food additive meets the following specifications:
(1) As found in "Food Chemicals Codex," National Academy of
Sciences/National Research Council (NAS/NRC), 3d Ed. (1981), 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 Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408) for the following:
L-Alanine
L-Arginine
L-Arginine Monohydrochloride
L-Cysteine Monohydrochloride
L-Cystine
Aminoacetic acid (glycine)
L-Leucine
DL-Methionine
[[Page 46]]
L-Methionine
L-Tryptophan
L-Phenylalanine
L-Proline
L-Serine
L-Threonine
Glutamic Acid Hydrochloride
L-Isoleucine
L-Lysine Monohydrochloride
Monopotassium L-glutamate
L-Tyrosine
L-Valine
(2) As found in "Specifications and Criteria for Biochemical
Compounds," NAS/NRC Publication, 3rd Ed. (1972), which is incorporated
by reference (copies are available from the Center for Food Safety and
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408) for the following:
L-Asparagine
L-Aspartic acid
L-Glutamine
L-Histidine
(c) The additive(s) is used or intended for use to significantly
improve the biological quality of the total protein in a food containing
naturally occurring primarily-intact protein that is considered a
significant dietary protein source, provided that:
(1) A reasonable daily adult intake of the finished food furnishes
at least 6.5 grams of naturally occurring primarily intact protein
(based upon 10 percent of the daily allowance for the "reference"
adult male recommended by the National Academy of Sciences in
"Recommended Dietary Allowances," NAS Publication No. 1694, 7th Ed.
(1968), which is incorporated by reference. Copies are available from
the Center for Food Safety and Applied Nutrition (HFS-200), Food and
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408.
(2) The additive(s) results in a protein efficiency ratio (PER) of
protein in the finished ready-to-eat food equivalent to casein as
determined by the method specified in paragraph (d) of this section.
(3) Each amino acid (or combination of the minimum number necessary
to achieve a statistically significant increase) added results in a
statistically significant increase in the PER as determined by the
method described in paragraph (d) of this section. The minimum amount of
the amino acid(s) to achieve the desired effect must be used and the
increase in PER over the primarily-intact naturally occurring protein in
the food must be substantiated as a statistically significant difference
with at least a probability (P) value of less than 0.05.
(4) The amount of the additive added for nutritive purposes plus the
amount naturally present in free and combined (as protein) form does not
exceed the following levels of amino acids expressed as percent by
weight of the total protein of the finished food:
------------------------------------------------------------------------
Percent by
weight of
total
protein
(expressed
as free
amino
acid)
------------------------------------------------------------------------
L-Alanine................................................... 6.1
L-Arginine.................................................. 6.6
L-Aspartic acid (including L-asparagine).................... 7.0
L-Cystine (including L-cysteine)............................ 2.3
L-Glutamic acid (including L-glutamine)..................... 12.4
Aminoacetic acid (glycine).................................. 3.5
L-Histidine................................................. 2.4
L-Isoleucine................................................ 6.6
L-Leucine................................................... 8.8
L-Lysine.................................................... 6.4
L- and DL-Methionine........................................ 3.1
L-Phenylalanine............................................. 5.8
L-Proline................................................... 4.2
L-Serine.................................................... 8.4
L-Threonine................................................. 5.0
L-Tryptophan................................................ 1.6
L-Tyrosine.................................................. 4.3
L-Valine.................................................... 7.4
------------------------------------------------------------------------
(d) Compliance with the limitations concerning PER under paragraph
(c) of this section shall be determined by the method described in
sections 43.212-43.216, "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 20408.
[[Page 47]]
Each manufacturer or person employing the additive(s) under the
provisions of this section shall keep and maintain throughout the period
of his use of the additive(s) and for a minimum of 3 years thereafter,
records of the tests required by this paragraph and other records
required to assure effectiveness and compliance with this regulation and
shall make such records available upon request at all reasonable hours
by any officer or employee of the Food and Drug Administration, or any
other officer or employee acting on behalf of the Secretary of Health
and Human Services and shall permit such officer or employee to conduct
such inventories of raw and finished materials on hand as he deems
necessary and otherwise to check the correctness of such records.
(e) To assure safe use of the additive, the label and labeling of
the additive and any premix thereof shall bear, in addition to the other
information required by the Act, the following:
(1) The name of the amino acid(s) contained therein including the
specific optical and chemical form.
(2) The amounts of each amino acid contained in any mixture.
(3) Adequate directions for use to provide a finished food meeting
the limitations prescribed by paragraph (c) of this section.
(f) The food additive amino acids added as nutrients to special
dietary foods that are intended for use solely under medical supervision
to meet nutritional requirements in specific medical conditions and
comply with the requirements of part 105 of this chapter are exempt from
the limitations in paragraphs (c) and (d) of this section and may be
used in such foods at levels not to exceed good manufacturing practices.
[42 FR 14491, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at
47 FR 11836, Mar. 19, 1982; 49 FR 10104, Mar. 19, 1984; 54 FR 24897,
June 12, 1989; 59 FR 14550, Mar. 29, 1994; 61 FR 14480, Apr. 2, 1996]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.325]
[Page 47]
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 D--Special Dietary and Nutritional Additives
Sec. 172.325 Bakers yeast protein.
Bakers yeast protein may be safely used in food in accordance with
the following conditions:
(a) Bakers yeast protein is the insoluble proteinaceous material
remaining after the mechanical rupture of yeast cells of Saccharomyces
cerevisiae and removal of whole cell walls by centrifugation and
separation of soluble cellular materials.
(b) The additive meets the following specifications on a dry weight
basis:
(1) Zinc salts less than 500 parts per million (ppm) as zinc.
(2) Nucleic acid less than 2 percent.
(3) Less than 0.3 ppm arsenic, 0.1 ppm cadmium, 0.4 ppm lead, 0.05
ppm mercury, and 0.3 ppm selenium.
(c) The viable microbial content of the finished ingredient is:
(1) Less than 10,000 organisms/gram by aerobic plate count.
(2) Less than 10 yeasts and molds/gram.
(3) Negative for Salmonella, E. coli, coagulase positive
Staphylococci, Clostridium perfringens, Clostridium botulinum, or any
other recognized microbial pathogen or any harmful microbial toxin.
(d) The ingredient is used in food as a nutrient supplement as
defined in Sec. 170.3(o)(20) of this chapter.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.330]
[Page 47]
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 D--Special Dietary and Nutritional Additives
Sec. 172.330 Calcium pantothenate, calcium chloride double salt.
The food additive calcium chloride double salt of calcium
pantothenate may be safely used in foods for special dietary uses in
accordance with good manufacturing practice and under the following
prescribed conditions:
(a) The food additive is of the d (dextrorotatory) or the dl
(racemic) form.
(b) To assure safe use of the additive, the label and labeling of
the food additive container, or that of any intermediate premixes
prepared therefrom, shall bear, in addition to the other information
required by the Act, the following:
(1) The name of the additive "calcium chloride double salt of d-
calcium pantothenate" or "calcium chloride double salt of dl-calcium
pantothenate", whichever is appropriate.
(2) A statement of the appropriate concentration of the additive,
expressed as pantothenic acid.
[[Page 48]]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.335]
[Page 48]
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 D--Special Dietary and Nutritional Additives
Sec. 172.335 D-Pantothenamide.
The food additive D-pantothenamide as a source of pantothenic acid
activity, may be safely used in foods for special dietary use in an
amount not in excess of that reasonably required to produce its intended
effect.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.340]
[Page 48]
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 D--Special Dietary and Nutritional Additives
Sec. 172.340 Fish protein isolate.
(a) The food additive fish protein isolate may be safely used as a
food supplement in accordance with the following prescribed conditions:
(1) The additive shall consist principally of dried fish protein
prepared from the edible portions of fish after removal of the heads,
fins, tails, bones, scales, viscera, and intestinal contents.
(2) The additive shall be derived only from species of bony fish
that are generally recognized by qualified scientists as safe for human
consumption and that can be processed as prescribed to meet the required
specifications.
(3) Only wholesome fresh fish otherwise suitable for human
consumption may be used. The fish shall be handled expeditiously under
sanitary conditions. These conditions shall be in accordance with
recognized good manufacturing practice for fish to be used as human
food.
(4) The additive shall be prepared by extraction with hexane and
food-grade ethanol to remove fat and moisture. Solvent residues shall be
reduced by drying.
(b) The food additive meets the following specifications: (Where
methods of determination are specified, they are Association of Official
Analytical Chemists Methods, 13th ed., 1980, which are incorporated by
reference). \1\
---------------------------------------------------------------------------
\1\ Copies are available from: Association of Official Analytical
Chemists International, 481 North Frederick Ave., suite 500,
Gaithersburg, MD 20877-2504, or examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
---------------------------------------------------------------------------
(1) Protein content, as N x 6.25, shall not be less than 90 percent
by weight of the final product, as determined by the method described in
section 2.057, Improved Kjeldahl Method for Nitrate-Free Samples (20)--
Official Final Action.
(2) Moisture content shall not be more than 10 percent by weight of
the final product, as determined by the method described in section
24.003, Air Drying (1)--Official First Action.
(3) Fat content shall not be more than 0.5 percent by weight of the
final product, as determined by the method described in section 24.005,
Crude Fat or Ether Extract--Official Final Action.
(4) Solvent residues in the final product shall not be more than 5
parts per million of hexane and 3.5 percent ethanol by weight.
[46 FR 38072, July 24, 1981, as amended at 47 FR 53344, Nov. 26, 1982;
54 FR 24897, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.345]
[Page 48-49]
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 D--Special Dietary and Nutritional Additives
Sec. 172.345 Folic acid (folacin).
Folic acid (CAS Reg. No. 59-30-3), also known as folacin or folate,
may be safely used in food as a nutrient in accordance with the
following prescribed conditions:
(a) Folic acid is the chemical N-[4-[[(2-amino-1,4-dihydro-4-oxo-6-
pteridinyl)methyl]amino]benzoyl]-L-glutamic acid.
(b) Folic acid meets the specifications of the "Food Chemicals
Codex," 4th ed. (1996), pp. 157-158, which is incorporated by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are
available from the National Academy Press, Box 285, 2101 Constitution
Ave. NW., Washington, DC 20055 (Internet address "http://
www.nap.edu"), or 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 Office of the Federal
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(c) Folic acid may be added to foods subject to a standard of
identity established under section 401 of the Federal Food, Drug, and
Cosmetic Act (the act) when the standard of identity specifically
provides for the addition of folic acid.
(d) Folic acid may be added, at levels not to exceed 400 micrograms
([mu]g) per serving, to breakfast cereals, as defined under
Sec. 170.3(n)(4) of this chapter, and to corn grits at a level such that
each pound of corn grits contains not more than 1.0 milligram of folic
acid.
[[Page 49]]
(e) Folic acid may be added to infant formula in accordance with
section 412(i)(1) of the act or with regulations issued under section
412(i)(2) of the act which are codified in Sec. 107.100 of this chapter.
(f) Folic acid may be added to a medical food, as defined in section
5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), at levels not to
exceed the amount necessary to meet the distinctive nutritional
requirements of the disease or condition for which the food is
formulated.
(g) Folic acid may be added to food for special dietary use at
levels not to exceed the amount necessary to meet the special dietary
needs for which the food is formulated.
(h) Folic acid may be added to foods represented as meal-replacement
products, in amounts not to exceed:
(1) Four hundred [mu]g per serving if the food is a meal-replacement
that is represented for use once per day; or
(2) Two hundred [mu]g per serving if the food is a meal-replacement
that is represented for use more than once per day.
[61 FR 8807, Mar. 5, 1996, as amended at 61 FR 27779, June 3, 1996; 64
FR 1758, Jan. 12, 1999]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.350]
[Page 49]
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 D--Special Dietary and Nutritional Additives
Sec. 172.350 Fumaric acid and salts of fumaric acid.
Fumaric acid and its calcium, ferrous, magnesium, potassium, and
sodium salts may be safely used in food in accordance with the following
prescribed conditions:
(a) The additives meet the following specifications:
(1) Fumaric acid contains a minimum of 99.5 percent by weight of
fumaric acid, calculated on the anhydrous basis.
(2) The calcium, magnesium, potassium, and sodium salts contain a
minimum of 99 percent by weight of the respective salt, calculated on
the anhydrous basis. Ferrous fumarate contains a minimum of 31.3 percent
total iron and not more than 2 percent ferric iron.
(b) With the exception of ferrous fumarate, fumaric acid and the
named salts are used singly or in combination in food at a level not in
excess of the amount reasonably required to accomplish the intended
effect.
(c) Ferrous fumarate is used as a source of iron in foods for
special dietary use, when the use is consistent with good nutrition
practice.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.365]
[Page 49]
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 D--Special Dietary and Nutritional Additives
Sec. 172.365 Kelp.
Kelp may be safely added to a food as a source of the essential
mineral iodine, provided the maximum intake of the food as may be
consumed during a period of one day, or as directed for use in the case
of a dietary supplement, will not result in daily ingestion of the
additive so as to provide a total amount of iodine in excess of 225
micrograms for foods labeled without reference to age or physiological
state; and when age or the conditions of pregnancy or lactation are
specified, in excess of 45 micrograms for infants, 105 micrograms for
children under 4 years of age, 225 micrograms for adults and children 4
or more years of age, and 300 micrograms for pregnant or lactating
women. The food additive kelp is the dehydrated, ground product prepared
from Macrocystis pyrifera, Laminaria digitata, Laminaria saccharina, and
Laminaria cloustoni.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.370]
[Page 49]
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 D--Special Dietary and Nutritional Additives
Sec. 172.370 Iron-choline citrate complex.
Iron-choline citrate complex made by reacting approximately
equimolecular quantities of ferric hydroxide, choline, and citric acid
may be safely used as a source of iron in foods for special dietary use.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.372]
[Page 49-50]
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 D--Special Dietary and Nutritional Additives
Sec. 172.372 N-Acetyl-L-methionine.
The food additive N-acetyl-L-methionine may be safely added to food
(except infant foods and foods containing added nitrites/nitrates) as a
source of L-methionine for use as a nutrient in accordance with the
following conditions:
(a) N-Acetyl-L-methionine (Chemical Abstracts Service Registry No.
65-82-7) is the derivative of the amino acid methionine formed by
addition of an acetyl group to the alpha-amino group of methionine. It
may be in the free, hydrated or anhydrous form, or as the sodium or
potassium salts.
(b) The additive meets the following specifications:
(1) Purity assay, on a dry basis: Minimum 99 percent.
[[Page 50]]
(2) Residue on ignition: Maximum 0.1 percent.
(3) Specific optical rotation [alpha]\20\D: Between -
19 deg. and -23 deg..
(4) The additive may contain residues of not more than 500 ppm ethyl
acetate; 50 ppm ethyl alcohol; 10 ppm methyl alcohol; and 10 ppm
acetone, when used as processing solvents.
(c) The additive is used or intended for use as a source of L-
methionine to improve significantly the biological quality of the total
protein in a food containing naturally occurring primarily intact
vegetable protein that is considered a significant dietary protein
source, provided that:
(1) A reasonable daily adult intake of the finished food furnishes
at least 6.5 grams of naturally occurring primarily intact vegetable
protein.
(2) The additive results in a protein efficiency ratio (PER) of
protein in the finished ready-to-eat food equivalent to casein as
determined by the method specified in paragraph (d) of this section.
(3) The use of the additive results in a statistically significant
increase in the PER as determined by the method described in paragraph
(d) of this section. The minimum amount of the additive to achieve the
desired effect must be used, and the increase in PER over the primarily
intact naturally occurring vegetable protein in the food must be
substantiated as a statistically significant difference with at least a
probability (P) value of less than 0.05.
(4) The amount of the additive added for nutritive purpose shall not
exceed the level that will provide a total of 3.1 percent L- and DL-
methionine (expressed as the free amino acid) by weight of the total
protein of the finished food, including the amount naturally present in
free and combined (as protein) form.
(5) The additive shall not be added to infant foods or to foods
containing added nitrites/nitrates.
(d) Compliance with the limitations concerning PER under paragraph
(c) of the section shall be determined by the method described in
sections 43.212-43.216, "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 20408. Each manufacturer or person employing the additive
under the provisions of this section shall keep and maintain throughout
the period of use of the additive and for a minimum of 3 years
thereafter, records of the tests required by this paragraph and other
records required to assure effectiveness and compliance with this
regulation. Those records shall be made available upon request at all
reasonable hours by any officer or employee acting on behalf of the
Secretary of Health and Human Services. Those officers or employees
shall be permitted to conduct inventories of raw and finished materials
on hand as are deemed necessary to verify the records.
(e) To assure safe use of the additive, the label and labeling of
the additive and any premix thereof shall bear, in addition to the other
information required by the Act, the following:
(1) The name of the additive contained therein.
(2) The amounts of additive and each amino acid contained in any
mixture.
(3) Adequate directions for use to provide a finished food meeting
the limitations prescribed by paragraph (c) of this section.
(f) When the food additive is added as a nutrient to special dietary
foods that are intended for use solely under medical supervision to meet
nutritional requirements in specific medical conditions and these foods
comply with the requirements of part 105 of this chapter, the food
additive is exempt from the limitations in paragraphs (c)(1) through (4)
and (d) of this section and may be used in those foods at levels not to
exceed good manufacturing practices.
[43 FR 27784, June 27, 1978, as amended at 46 FR 59968, Dec. 8, 1981; 49
FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989]
[[Page 51]]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.375]
[Page 51]
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 D--Special Dietary and Nutritional Additives
Sec. 172.375 Potassium iodide.
The food additive potassium iodide may be safely used in accordance
with the following prescribed conditions:
(a) Potassium iodide may be safely added to a food as a source of
the essential mineral iodine, provided the maximum intake of the food as
may be consumed during a period of one day, or as directed for use in
the case of a dietary supplement, will not result in daily ingestion of
the additive so as to provide a total amount of iodine in excess of 225
micrograms for foods labeled without reference to age or physiological
state; and when age or the conditions of pregnancy or lactation are
specified, in excess of 45 micrograms for infants, 105 micrograms for
children under 4 years of age, 225 micrograms for adults and children 4
or more years of age, and 300 micrograms for pregnant or lactating
women.
(b) To assure safe use of the additive, in addition to the other
information required by the Act, the label of the additive shall bear:
(1) The name of the additive.
(2) A statement of the concentration of the additive in any mixture.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.380]
[Page 51]
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 D--Special Dietary and Nutritional Additives
Sec. 172.380 Vitamin D3.
The food additive may be used safely in foods as a nutrient
supplement defined under Sec. 170.3(o)(20) of this chapter in accordance
with the following prescribed conditions:
(a) Vitamin D3, also known as cholecalciferol, is the
chemical 9,10-seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. Vitamin
D3 occurs in and is isolated from fish liver oils. It also is
manufactured by ultraviolet irradiation of 7-dehydrocholesterol produced
from cholesterol and is purified by crystallization.
(b) Vitamin D3 meets the specifications of the Food
Chemicals Codex, 4\th\ ed. (1996), p. 434, 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 the Office of the Federal
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(c) Vitamin D3 may be added, at levels not to exceed 100
International Units (IU) per serving, to 100 percent fruit juices, as
defined under Sec. 170.3(n)(35) of this chapter, excluding fruit juices
that are specially formulated or processed for infants, that are
fortified with greater than 33 percent of the Recommended Daily Intake
(RDI) of calcium per Reference Amount Customarily Consumed (RACC).
(d) Vitamin D3 may be added, at levels not to exceed 100
IU per serving, to fruit drinks, as defined under Sec. 170.3(n)(35) of
this chapter, excluding fruit drinks that are specially formulated or
processed for infants, that are fortified with greater than 10 percent
of the RDI of calcium per RACC.
[68 FR 9003, Feb. 27, 2003]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.385]
[Page 51-52]
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 D--Special Dietary and Nutritional Additives
Sec. 172.385 Whole fish protein concentrate.
The food additive whole fish protein concentrate may be safely used
as a food supplement in accordance with the following prescribed
conditions:
(a) The additive is derived from whole, wholesome hake and hakelike
fish, herring of the genera Clupea, menhaden, and anchovy of the species
Engraulis mordax, handled expeditiously and under sanitary conditions in
accordance with good manufacturing practices recognized as proper for
fish that are used in other forms for human food.
(b) The additive consists essentially of a dried fish protein
processed from the whole fish without removal of heads, fins, tails,
viscera, or intestinal contents. It is prepared by solvent extraction of
fat and moisture with isopropyl alcohol or with ethylene dichloride
followed by isopropyl alcohol, except that the additive derived from
herring, menhaden and anchovy is prepared by solvent extraction with
isopropyl alcohol alone. Solvent residues are reduced by conventional
heat drying and/or microwave radiation and there is a partial removal of
bone.
(c) The food additive meets the following specifications:
[[Page 52]]
(1) Protein content (N x 6.25) shall not be less than 75 percent by
weight of the final product, as determined by the method described in
section 2.057 in "Official Methods of Analysis of the Association of
Official Analytical Chemists" (AOAC), 13th Ed. (1980). Protein quality
shall not be less than 100, as determined by the method described in
sections 43.212-43.216 of the AOAC. The 13th Ed. is incorporated by
reference, and 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 20408.
(2) Moisture content shall not exceed 10 percent by weight of the
final product, as determined by the method described in section 24.003
of the AOAC. See paragraph (c)(1) of this section for availability of
the material incorporated by reference.
(3) Fat content shall not exceed 0.5 percent by weight of the final
product, as determined by the method described in section 24.005 of the
AOAC. See paragraph (c)(1) of the this section for availability of the
material incorporated by reference.
(4) The additive may contain residues of isopropyl alcohol and
ethylene dichloride not in excess of 250 parts per million and 5 parts
per million, respectively, when used as solvents in the extraction
process.
(5) Microwave radiation meeting the requirements of Sec. 179.30 of
this chapter may be used to reduce residues of the solvents used in the
extraction process.
(6) The additive shall contain not in excess of 100 parts per
million fluorides (expressed as F).
(7) The additive shall be free of Escherichia coli and pathogenic
organisms, including Salmonella, and shall have a total bacterial plate
count of not more than 10,000 per gram.
(8) The additive shall have no more than a faint characteristic fish
odor and taste.
(d) When the additive is used or intended for use in the household
as a protein supplement in food for regular consumption by children up
to 8 years of age, the amount of the additive from this source shall not
exceed 20 grams per day (about one heaping tablespoon).
(e) When the additive is used as a protein supplement in
manufactured food, the total fluoride content (expressed as F) of the
finished food shall not exceed 8 ppm based on the dry weight of the food
product.
(f) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of consumer-sized or bulk containers of the additive
shall bear the name "whole fish protein concentrate".
(2) The label or labeling of containers of the additive shall bear
adequate directions for use to comply with the limitations prescribed by
paragraphs (d) and (e) of this section.
(3) Labels of manufactured foods containing the additive shall bear,
in the ingredient statement, the name of the additive, "whole fish
protein concentrate" in the proper order of decreasing predominance in
the finished food.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10104, Mar. 19, 1984;
54 FR 24897, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.395]
[Page 52]
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 D--Special Dietary and Nutritional Additives
Sec. 172.395 Xylitol.
Xylitol may be safely used in foods for special dietary uses,
provided the amount used is not greater than that required to produce
its intended effect.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.399]
[Page 52]
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 D--Special Dietary and Nutritional Additives
Sec. 172.399 Zinc methionine sulfate.
Zinc methionine sulfate, CAS Reg. No. 56329-42-1, may be safely used
in accordance with the following prescribed conditions:
(a) The additive is the product of the reaction between equimolar
amounts of zinc sulfate and DL-methionine in purified water.
(b) The additive meets the following specifications:
Zinc content--19 to 22 percent.
C5H11NO2S "DL-methionine"--46 to 50
percent.
Cadmium--not more than 0.05 part per million.
(c) The additive is used in tablet form as a source of dietary zinc.
[46 FR 58297, Dec. 1, 1981]
[[Page 53]]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.410]
[Page 53]
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 E--Anticaking Agents
Sec. 172.410 Calcium silicate.
Calcium silicate, including synthetic calcium silicate, may be
safely used in food in accordance with the following prescribed
conditions:
(a) It is used as an anticaking agent in food in an amount not in
excess of that reasonably required to produce its intended effect.
(b) It will not exceed 2 percent by weight of the food, except that
it may be present up to 5 percent by weight of baking powder.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.430]
[Page 53]
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 E--Anticaking Agents
Sec. 172.430 Iron ammonium citrate.
Iron ammonium citrate may be safely used in food in accordance with
the following prescribed conditions:
(a) The additive is the chemical green ferric ammonium citrate.
(b) The additive is used, or intended for use as an anticaking agent
in salt for human consumption so that the level of iron ammonium citrate
does not exceed 25 parts per million (0.0025 percent) in the finished
salt.
(c) To assure safe use of the additive the label or labeling of the
additive shall bear, in addition to the other information required by
the Act:
(1) The name of the additive.
(2) Adequate directions to provide a final product that complies
with the limitations prescribed in paragraph (b) of this section.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.480]
[Page 53]
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 E--Anticaking Agents
Sec. 172.480 Silicon dioxide.
The food additive silicon dioxide may be safely used in food in
accordance with the following conditions:
(a) The food additive is manufactured by vapor phase hydrolysis or
by other means whereby the particle size is such as to accomplish the
intended effect.
(b) It is used as an anticaking agent, subject to the following
conditions:
(1) It is used in only those foods in which the additive has been
demonstrated to have an anticaking effect.
(2) It is used in an amount not in excess of that reasonably
required to produce its intended effect.
(3) [Reserved]
(4) It is used in an amount not to exceed 2 percent by weight of the
food.
(c) It is used or intended for use as a stabilizer in the production
of beer, and is removed from the beer by filtration prior to final
processing.
(d) It is used or intended for use as an adsorbent for dl-a-
tocopheryl acetate and pantothenyl alcohol in tableted foods for special
dietary use, in an amount not greater than that required to accomplish
the intended physical or technical effect.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.490]
[Page 53]
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 E--Anticaking Agents
Sec. 172.490 Yellow prussiate of soda.
(a) The food additive yellow prussiate of soda (sodium ferrocyanide
decahydrate; Na4Fe(CN)6[middot]10H2O
contains a minimum of 99 percent by weight of sodium ferrocyanide
decahydrate.
(b) The additive is used or intended for use as an anticaking agent
in salt and as an adjuvant in the production of dendritic crystals of
salt in an amount needed to produce its intended effect but not in
excess of 13 parts per million calculated as anhydrous sodium
ferrocyanide.
[42 FR 14491, Mar. 15, 1977, as amended at 58 FR 17098, Apr. 1, 1993]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.510]
[Page 53-56]
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 F--Flavoring Agents and Related Substances
Sec. 172.510 Natural flavoring substances and natural substances used in conjunction with flavors.
Natural flavoring substances and natural adjuvants may be safely
used in food in accordance with the following conditions.
(a) They are used in the minimum quantity required to produce their
intended physical or technical effect and in accordance with all the
principles of good manufacturing practice.
(b) In the appropriate forms (plant parts, fluid and solid extracts,
concretes, absolutes, oils, gums, balsams, resins, oleoresins, waxes,
and distillates) they consist of one or more of the following, used
alone or in combination with flavoring substances and adjuvants
generally recognized as safe in food, previously sanctioned for such
use, or regulated in any section of this part.
[[Page 54]]
----------------------------------------------------------------------------------------------------------------
Common name Scientific name Limitations
----------------------------------------------------------------------------------------------------------------
Aloe............................................. Aloe perryi Baker, A.
barbadensis Mill., A. ferox
Mill., and hybrids of this
sp. with A. africana Mill.
and A. spicata Baker.
Althea root and flowers.......................... Althea officinalis L........
Amyris (West Indian sandalwood).................. Amyris balsamifera L........
Angola weed...................................... Roccella fuciformis Ach..... In alcoholic beverages only
Arnica flowers................................... Arnica montana L., A. Do.
fulgens Pursh, A. sororia
Greene, or A. cordifolia
Hooker.
Artemisia (wormwood)............................. Artemisia spp............... Finished food thujone free\1\
Artichoke leaves................................. Cynara scolymus L........... In alcoholic beverages only
Benzoin resin.................................... Styrax benzoin Dryander, S.
paralleloneurus Perkins, S.
tonkinensis (Pierre) Craib
ex Hartwich, or other spp.
of the Section Anthostyrax
of the genus Styrax.
Blackberry bark.................................. Rubus, Section Eubatus......
Boldus (boldo) leaves............................ Peumus boldus Mol........... Do.
Boronia flowers.................................. Boronia megastigma Nees.....
Bryonia root..................................... Bryonia alba L., or B. Do.
diocia Jacq.
Buchu leaves..................................... Barosma betulina Bartl. et
Wendl., B. crenulata (L.)
Hook. or B. serratifolia
Willd.
Buckbean leaves.................................. Menyanthes trifoliata L..... Do.
Cajeput.......................................... Melaleuca leucadendron L.
and other Melaleuca spp.
Calumba root..................................... Jateorhiza palmata (Lam.) Do.
Miers.
Camphor tree..................................... Cinnamomum camphora (L.) Safrole free
Nees et Eberm.
Cascara sagrada.................................. Rhamnus purshiana DC........
Cassie flowers................................... Acacia farnesiana (L.) Willd
Castor oil....................................... Ricinus communis L..........
Catechu, black................................... Acacia catechu Willd........
Cedar, white (aborvitae), leaves and twigs....... Thuja occidentalis L........ Finished food thujone free\1\
Centuary......................................... Centaurium umbellatum Gilib. In alcoholic beverages only
Cherry pits...................................... Prunus avium L. or P. Not to exceed 25 p.p.m. prussic
cerasus L. acid
Cherry-laurel leaves............................. Prunus laurocerasus L....... Do.
Chestnut leaves.................................. Castanea dentata (Marsh.)
Borkh.
Chirata.......................................... Swertia chirata Buch.-Ham... In alcoholic beverages only
Cinchona, red, bark.............................. Cinchona succirubra Pav. or In beverages only; not more
its hybrids. than 83 p.p.m. total cinchona
alkaloids in finished beverage
Cinchona, yellow, bark........................... Cinchona ledgeriana Moens, Do.
C. calisaya Wedd., or
hybrids of these with other
spp. of Cinchona..
Copaiba.......................................... South American spp. of
Copaifera L.
Cork, oak........................................ Quercus suber L., or Q. In alcoholic beverages only
occidentalis F. Gay.
Costmary......................................... Chrysanthemum balsamita L... Do.
Costus root...................................... Saussurea lappa Clarke......
Cubeb............................................ Piper cubeba L. f...........
Currant, black, buds and leaves.................. Ribes nigrum L..............
Damiana leaves................................... Turnera diffusa Willd.......
Davana........................................... Artemisia pallens Wall......
Dill, Indian..................................... Anethum sowa Roxb.
(Peucedanum graveolens
Benth et Hook., Anethum
graveolens L.).
Dittany (fraxinella) roots....................... Dictamnus albus L........... Do.
Dittany of Crete................................. Origanum dictamnus L........
Dragon's blood (dracorubin)...................... Daemonorops spp.............
Elder tree leaves................................ Sambucus nigra L............ In alcoholic beverages only;
not to exceed 25 p.p.m.
prussic acid in the flavor
Elecampane rhizome and roots..................... Inula helenium L............ In alcoholic beverages only
Elemi............................................ Canarium commune L. or C.
luzonicum Miq.
Erigeron......................................... Erigeron canadensis L.......
Eucalyptus globulus leaves....................... Eucalyptus globulus Labill..
Fir ("pine") needles and twigs................. Abies sibirica Ledeb., A.
alba Mill., A. sachalinesis
Masters or A. mayriana
Miyabe et Kudo.
Fir, balsam, needles and twigs................... Abies balsamea (L.) Mill....
Galanga, greater................................. Alpinia galanga Willd....... Do.
[[Page 55]]
Galbanum......................................... Ferula galbaniflua Boiss. et
Buhse and other Ferula spp.
Gambir (catechu, pale)........................... Uncaria gambir Roxb.........
Genet flowers.................................... Spartium junceum L..........
Gentian rhizome and roots........................ Gentiana lutea L............
Gentian, stemless................................ Gentiana acaulis L.......... Do.
Germander, chamaedrys............................ Teucrium chamaedrys L....... Do.
Germander, golden................................ Teucrium polium L........... Do.
Guaiac........................................... Guaiacum officinale L., G.
santum L., Bulnesia
sarmienti Lor.
Guarana.......................................... Paullinia cupana HBK........
Haw, black, bark................................. Viburnum prunifolium L......
Hemlock needles and twigs........................ Tsuga canadensis (L.) Carr.
or T. heterophylla (Raf.)
Sarg.
Hyacinth flowers................................. Hyacinthus orientalis L.....
Iceland moss..................................... Cetraria islandica Ach...... Do.
Imperatoria...................................... Peucedanum ostruthium (L.).
Koch (Imperatoria
ostruthium L.).
Iva.............................................. Achillea moschata Jacq...... Do.
Labdanum......................................... Cistus spp..................
Lemon-verbena.................................... Lippia citriodora HBK....... Do.
Linaloe wood..................................... Bursera delpechiana Poiss.
and other Bursera spp.
Linden leaves.................................... Tillia spp.................. Do.
Lovage........................................... Levisticum officinale Koch..
Lungmoss (lungwort).............................. Sticta pulmonacea Ach.......
Maidenhair fern.................................. Adiantum capillus-veneris L. Do.
Maple, mountain.................................. Acer spicatum Lam...........
Mimosa (black wattle) flowers.................... Acacia decurrens Willd. var.
dealbata.
Mullein flowers.................................. Verbascum phlomoides L. or Do.
V. thapsiforme Schrad.
Myrrh............................................ Commiphora molmol Engl., C.
abyssinica (Berg) Engl., or
other Commiphora spp.
Myrtle leaves.................................... Myrtus communis L........... Do.
Oak, English, wood............................... Quercus robur L............. Do.
Oak, white, chips................................ Quercus alba L..............
Oak moss......................................... Evernia prunastri (L.) Ach., Finished food thujone
E. furfuracea (L.) Mann,
and other lichens.
Olibanum......................................... Boswellia carteri Birdw. and
other Boswellia spp.
Opopanax (bisabolmyrrh).......................... Opopanax chironium Koch
(true opopanax) of
Commiphora erythraea Engl.
var. Llabrescens.
Orris root....................................... Iris germanica L. (including
its variety florentina
Dykes) and I. pallida Lam.
Pansy............................................ Viola tricolor L............ In alcoholic beverages only
Passion flower................................... Passiflora incarnata L......
Patchouly........................................ Pogostemon cablin Benth. and
P. heyneanus Benth.
Peach leaves..................................... Prunus persica (L.) Batsch.. In alcoholic beverages only;
not to exceed 25 p.p.m.
prussic acid in the flavor
Pennyroyal, American............................. Hedeoma pulegioides (L.)
Pers.
Pennyroyal, European............................. Mentha pulegium L...........
Pine, dwarf, needles and twigs................... Pinus mugo Turra var.
pumilio (Haenke) Zenari.
Pine, Scotch, needles and twigs.................. Pinus sylvestris L..........
Pine, white, bark................................ Pinus strobus L............. In alcoholic beverages only
Pine, white oil.................................. Pinus palustris Mill., and
other Pinus spp.
Poplar buds...................................... Populus balsamifera L. (P. Do.
tacamahacca Mill.), P.
candicans Ait., or P. nigra
L.
Quassia.......................................... Picrasma excelsa (Sw.)
Planch, or Quassia amara L.
Quebracho bark................................... Aspidosperma quebracho- Schinopsis lorentzii (Griseb.)
blanco Schlecht, or Engl.
(Quebrachia lorentzii
(Griseb)).
Quillaia (soapbark).............................. Quillaja saponaria Mol......
Red saunders (red sandalwood).................... Pterocarpus san alinus L.... In alcoholic beverages only
Rhatany root..................................... Krameria triandra Ruiz et
Pav. or K. argentea Mart.
Rhubarb, garden root............................. Rheum rhaponticum L......... Do.
Rhubarb root..................................... Rheum officinale Baill., R.
palmatum L., or other spp.
(excepting R. rhaponticum
L.) or hybrids of Rheum
grown in China.
Roselle.......................................... Hibiscus sabdariffa L....... Do.
Rosin (colophony)................................ Pinus palustris Mill., and Do.
other Pinus spp.
St. Johnswort leaves, flowers, and caulis........ Hypericum perforatum L...... Hypericin-free alcohol
distillate form only; in
alcoholic beverages only
[[Page 56]]
Sandalwood, white (yellow, or East Indian)....... Santalum album L............
Sandarac......................................... Tetraclinis articulata In alcoholic beverages only
(Vahl.), Mast.
Sarsaparilla..................................... Smilax aristolochiaefolia
Mill., (Mexican
sarsaparilla), S. regelii
Killip et Morton (Honduras
sarsaparilla), S. febrifuga
Kunth (Ecuadorean
sarsaparilla), or
undetermined Smilax spp.
(Ecuadorean or Central
American sarsaparilla).
Sassafras leaves................................. Sassafras albidum (Nutt.) Safrole free
Nees.
Senna, Alexandria................................ Cassia acutifolia Delile....
Serpentaria (Virginia snakeroot)................. Aristolochia serpentaria L.. In alcoholic beverages only
Simaruba bark.................................... Simaruba amara Aubl......... Do.
Snakeroot, Canadian (wild ginger)................ Asarum canadense L..........
Spruce needles and twigs......................... Picea glauca (Moench) Voss
or P. mariana (Mill.) BSP.
Storax (styrax).................................. Liquidambar orientalis Mill.
or L. styraciflua L.
Tagetes (marigold)............................... Tagetes patula L., T. erecta As oil only
L., or T. minuta L. (T.
glandulifera Schrank).
Tansy............................................ Tanacetum vulgare L......... In alcoholic beverages only;
finished alcoholic beverage
thujone free\1\
Thistle, blessed (holy thistle).................. Onicus benedictus L......... In alcoholic beverages only
Thymus capitatus (Spanish "origanum").......... Thymus capitatus Hoffmg. et
Link.
Tolu............................................. Myroxylon balsamum (L.)
Harms.
Turpentine....................................... Pinus palustris Mill. and
other Pinus spp. which
yield terpene oils
exclusively.
Valerian rhizome and roots....................... Valeriana officinalis L.....
Veronica......................................... Veronica officinalis L...... Do.
Vervain, European................................ Verbena officinalis L....... Do.
Vetiver.......................................... Vetiveria zizanioides Stapf. Do.
Violet, Swiss.................................... Viola calcarata L...........
Walnut husks (hulls), leaves, and green nuts..... Juglans nigra L. or J. regia
L.
Woodruff, sweet.................................. Asperula odorata L.......... In alcoholic beverages only
Yarrow........................................... Achillea millefolium L...... In beverages only; finished
beverage thujone free\1\
Yerba santa...................................... Eriodictyon californicum
(Hook, et Arn.) Torr.
Yucca, Joshua-tree............................... Yucca brevifolia Engelm.....
Yucca, Mohave.................................... Yucca schidigera Roezl ex
Ortgies (Y. mohavensis
Sarg.).
----------------------------------------------------------------------------------------------------------------
\1\ As determined by using the method (or, in other than alcoholic beverages, a suitable adaptation thereof) in
section 9.129 of the "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 Frederic 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 20408
[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 14644, Apr. 7, 1978; 49
FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.515]
[Page 56-63]
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 F--Flavoring Agents and Related Substances
Sec. 172.515 Synthetic flavoring substances and adjuvants.
Synthetic flavoring substances and adjuvants may be safely used in
food in accordance with the following conditions.
(a) They are used in the minimum quantity required to produce their
intended effect, and otherwise in accordance with all the principles of
good manufacturing practice.
(b) They consist of one or more of the following, used alone or in
combination with flavoring substances and adjuvants generally recognized
as safe in food, prior-sanctioned for such use, or regulated by an
appropriate section in this part.
Acetal; acetaldehyde diethyl acetal.
Acetaldehyde phenethyl propyl acetal.
Acetanisole; 4'-methoxyacetophenone.
Acetophenone; methyl phenyl ketone.
Allyl anthranilate.
Allyl butyrate.
Allyl cinnamate.
Allyl cyclohexaneacetate.
Allyl cyclohexanebutyrate.
Allyl cyclohexanehexanoate.
Allyl cyclohexaneproprionate.
Allyl cyclohexanevalerate.
Allyl disulfide.
[[Page 57]]
Allyl 2-ethylbutyrate.
Allyl hexanoate; allyl caproate.
Allyl [alpha]-ionone; 1-(2,6,6-trimethyl-2-cyclo-hexene-1-yl)-1,6-
heptadiene-3-one.
Allyl isothiocyanate; mustard oil.
Allyl isovalerate.
Allyl mercaptan; 2-propene-1-thiol.
Allyl nonanoate.
Allyl octanoate.
Allyl phenoxyacetate.
Allyl phenylacetate.
Allyl propionate.
Allyl sorbate; allyl 2,4-hexadienoate.
Allyl sulfide.
Allyl tiglate; allyl trans-2-methyl-2-butenoate.
Allyl 10-undecenoate.
Ammonium isovalerate.
Ammonium sulfide.
Amyl alcohol; pentyl alcohol.
Amyl butyrate.
[alpha]-Amylcinnamaldehyde.
[alpha]-Amylcinnamaldehyde dimethyl acetal.
[alpha]-Amylcinnamyl acetate.
[alpha]-Amylcinnamyl alcohol.
[alpha]-Amylcinnamyl formate.
[alpha]-Amylcinnamyl isovalerate.
Amyl formate.
Amyl heptanoate.
Amyl hexanoate.
Amyl octanoate.
Anisole; methoxybenzene.
Anisyl acetate.
Anisyl alcohol; p-methoxybenzyl alcohol.
Anisyl butyrate
Anisyl formate.
Anisyl phenylacetate.
Anisyl propionate.
Beechwood creosote.
Benzaldehyde dimethyl acetal.
Benzaldehyde glyceryl acetal; 2-phenyl-m-dioxan-5-ol.
Benzaldehyde propylene glycol acetal; 4-methyl-2-phenyl-m-dioxolane.
Benzenethiol; thiophenol.
Benzoin; 2-hydroxy-2-phenylacetophenone.
Benzophenone; diphenylketone.
Benzyl acetate.
Benzyl acetoacetate.
Benzyl alcohol.
Benzyl benzoate.
Benzyl butyl ether.
Benzyl butyrate.
Benzyl cinnamate.
Benzyl 2,3-dimethylcrotonate; benzyl methyl tiglate.
Benzyl disulfide; dibenzyl disulfide.
Benzyl ethyl ether.
Benzyl formate.
3-Benzyl-4-heptanone; benzyl dipropyl ketone.
Benzyl isobutyrate.
Benzyl isovalerate.
Benzyl mercaptan; [alpha]-toluenethiol.
Benzyl methoxyethyl acetal; acetaldehyde benzyl [beta]-methoxyethyl
acetal.
Benzyl phenylacetate.
Benzyl propionate.
Benzyl salicylate.
Birch tar oil.
Borneol; d-camphanol.
Bornyl acetate.
Bornyl formate.
Bornyl isovalerate.
Bornyl valerate.
[beta]-Bourbonene; 1,2,3,3a,3b[beta],4,5,6,6a[beta],6b[alpha]-deca-
hydro-l[alpha]-isopropyl-3aa-methyl-6-methylene-cyclobuta
[1,2:3,4] dicyclopentene.
2-Butanol.
2-Butanone; methyl ethyl ketone.
Butter acids.
Butter esters.
Butyl acetate.
Butyl acetoacetate.
Butyl alcohol; 1-butanol.
Butyl anthranilate.
Butyl butyrate.
Butyl butyryllactate; lactic acid, butyl ester, butyrate.
[alpha]-Butylcinnamaldehyde.
Butyl cinnamate.
Butyl 2-decenoate.
Butyl ethyl malonate.
Butyl formate.
Butyl heptanoate.
Butyl hexanoate.
Butyl p-hydroxybenzoate.
Butyl isobutyrate.
Butyl isovalerate.
Butyl lactate.
Butyl laurate.
Butyl levulinate.
Butyl phenylacetate.
Butyl propionate.
Butyl stearate.
Butyl sulfide.
Butyl 10-undecenoate.
Butyl valerate.
Butyraldehyde.
Cadinene.
Camphene; 2,2-dimethyl-3-methylenenorbornane.
d-Camphor.
Carvacrol; 2-p-cymenol.
Carvacryl ethyl ether; 2-ethoxy-p-cymene.
Carveol; p-mentha-6,8-dien-2-ol.
4-Carvomenthenol; 1-p-menthen-4-ol; 4-terpinenol.
cis Carvone oxide; 1,6-epoxy-p-menth-8-en-2-one.
Carvyl acetate.
Carvyl propionate.
[beta]-Caryophyllene.
Caryophyllene alcohol.
Caryophyllene alcohol acetate.
[beta]-Caryophyllene oxide; 4-12,12-trimethyl-9-methylene-5-oxatricylo
[8.2.0.04, 6] dodecane.
Cedarwood oil alcohols.
Cedarwood oil terpenes.
1,4-Cineole.
Cinnamaldehyde ethylene glycol acetal.
Cinnamic acid.
Cinnamyl acetate.
[[Page 58]]
Cinnamyl alcohol; 3-phenyl-2-propen-1-ol.
Cinnamyl benzoate.
Cinnamyl butyrate.
Cinnamyl cinnamate.
Cinnamyl formate.
Cinnamyl isobutyrate.
Cinnamyl isovalerate.
Cinnamyl phenylacetate.
Cinnamyl propionate.
Citral diethyl acetal; 3,7-dimethyl-2,6-octadienal diethyl acetal.
Citral dimethyl acetal; 3,7-dimethyl-2,6-octadienal dimethyl acetal.
Citral propylene glycol acetal.
Citronellal; 3,7-dimethyl-6-octenal; rhodinal.
Citronellol; 3,7-dimethyl-6-octen-1-ol; d-citronellol.
Citronelloxyacetaldehyde.
Citronellyl acetate.
Citronellyl butyrate.
Citronellyl formate.
Citronellyl isobutyrate.
Citronellyl phenylacetate.
Citronellyl propionate.
Citronellyl valerate.
p-Cresol.
Cuminaldehyde; cuminal; p-isopropyl benzaldehyde.
Cyclohexaneacetic acid.
Cyclohexaneethyl acetate.
Cyclohexyl acetate.
Cyclohexyl anthranilate.
Cyclohexyl butyrate.
Cyclohexyl cinnamate.
Cyclohexyl formate.
Cyclohexyl isovalerate.
Cyclohexyl propionate.
p-Cymene.
[gamma]-Decalactone; 4-hydroxy-decanoic acid, [gamma]-lactone.
[gamma]-Decalactone; 5-hydroxy-decanoic acid, [delta]-lactone.
Decanal dimethyl acetal.
1-Decanol; decylic alcohol.
2-Decenal.
3-Decen-2-one; heptylidene acetone.
Decyl actate.
Decyl butyrate.
Decyl propionate.
Dibenzyl ether.
4,4-Dibutyl-[gamma]-butyrolactone; 4,4-dibutyl-4-hydroxy-butyric acid,
[gamma]-lactone.
Dibutyl sebacate.
Diethyl malate.
Diethyl malonate; ethyl malonate.
Diethyl sebacate.
Diethyl succinate.
Diethyl tartrate.
2,5-Diethyltetrahydrofuran.
Dihydrocarveol; 8-p-menthen-2-ol; 6-methyl-3-isopropenylcyclohexanol.
Dihydrocarvone.
Dihydrocarvyl acetate.
m-Dimethoxybenzene.
p-Dimethoxybenzene; dimethyl hydroquinone.
2,4-Dimethylacetophenone.
[alpha],[alpha]-Dimethylbenzyl isobutyrate; phenyldimethylcarbinyl
isobutyrate.
2,6-Dimethyl-5-heptenal.
2,6-Dimethyl octanal; isodecylaldehyde.
3,7-Dimethyl-1-octanol; tetrahydrogeraniol.
[alpha],[alpha]-Dimethylphenethyl acetate; benzylpropyl acetate;
benzyldimethylcarbinyl acetate.
[alpha],[alpha]-Dimethylphenethyl alcohol; dimethylbenzyl carbinol.
[alpha],[alpha]-Dimethylphenethyl butyrate; benzyldimethylcarbinyl
butyrate.
[alpha],[alpha]-Dimethylphenethyl formate; benzyldimethylcarbinyl
formate.
Dimethyl succinate.
1,3-Diphenyl-2-propanone; dibenzyl ketone.
delta-Dodecalactone; 5-hydroxydodecanoic acid, deltalactone.
[gamma]-Dodecalactone; 4-hydroxydodecanoic acid [gamma]-lactone.
2-Dodecenal.
Estragole.
[rho]-Ethoxybenzaldehyde.
Ethyl acetoacetate.
Ethyl 2-acetyl-3-phenylpropionate; ethylbenzyl acetoacetate.
Ethyl aconitate, mixed esters.
Ethyl acrylate.
Ethyl [rho]-anisate.
Ethyl anthranilate.
Ethyl benzoate.
Ethyl benzoylacetate.
[alpha]-Ethylbenzyl butyrate; [alpha]-phenylpropyl butyrate.
Ethyl brassylate; tridecanedioic acid cyclic ethylene glycol diester;
cyclo 1,13-ethyl-enedioxytridecan-1,13-dione.
2-Ethylbutyl acetate.
2-Ethylbutyraldehyde.
2-Ethylbutyric acid.
Ethyl cinnamate.
Ethyl crotonate; trans-2-butenoic acid ethylester.
Ethyl cyclohexanepropionate.
Ethyl decanoate.
2-Ethylfuran.
Ethyl 2-furanpropionate.
4-Ethylguaiacol; 4-ethyl-2-methoxyphenol.
Ethyl heptanoate.
2-Ethyl-2-heptenal; 2-ethyl-3-butylacrolein.
Ethyl hexanoate.
Ethyl isobutyrate.
Ethyl isovalerate.
Ethyl lactate.
Ethyl laurate.
Ethyl levulinate.
Ethyl maltol; 2-ethyl-3-hydroxy-4H-pyran-4-one.
Ethyl 2-methylbutyrate.
Ethyl myristate.
Ethyl nitrite.
Ethyl nonanoate.
Ethyl 2-nonynoate; ethyl octyne carbonate.
Ethyl octanoate.
Ethyl oleate.
Ethyl phenylacetate.
Ethyl 4-phenylbutyrate.
[[Page 59]]
Ethyl 3-phenylglycidate.
Ethyl 3-phenylpropionate; ethyl hydrocinnamate.
Ethyl propionate.
Ethyl pyruvate.
Ethyl salicylate.
Ethyl sorbate; ethyl 2,4-hexadienoate.
Ethyl tiglate; ethyl trans-2-methyl-2-butenoate.
Ethyl undecanoate.
Ethyl 10-undecenoate.
Ethyl valerate.
Eucalyptol; 1,8-epoxy-p-menthane; cineole.
Eugenyl acetate.
Eugenyl benzoate.
Eugenyl formate.
Eugenyl methyl ether; 4-allylveratrole; methyl eugenol.
Farnesol; 3,7,11-trimethyl-2,6,10-dodecatrien-1-ol.
d-Fenchone; d-1,3,3-trimethyl-2-norbornanone.
Fenchyl alcohol; 1,3,3-trimethyl-2-norbornanol.
Formic acid
(2-Furyl)-2-propanone; furyl acetone.
1-Furyl-2-propanone; furyl acetone.
Fusel oil, refined (mixed amyl alcohols).
Geranyl acetoacetate; trans-3,7-dimethyl-2, 6-octadien-1-yl
acetoacetate.
Geranyl acetone; 6,10-dimethyl-5,9-undecadien-2-one.
Geranyl benzoate.
Geranyl butyrate.
Geranyl formate.
Geranyl hexanoate
Geranyl isobutyrate.
Geranyl isovalerate.
Geranyl phenylacetate.
Geranyl propionate.
Glucose pentaacetate.
Guaiacol; [mu]-methoxyphenol.
Guaiacyl acetate; [mu]-methoxyphenyl acetate.
Guaiacyl phenylacetate.
Guaiene; 1,4-dimethyl-7-isopropenyl-[Delta]9,10-octahydroazulene.
Guaiol acetate; 1,4-dimethyl-7-([alpha]-hydroxy-isopropyl)-[delta]9,10-
octahydroazulene acetate.
[gamma]-Heptalactone; 4-hydroxyheptanoic acid, [gamma]-lactone.
Heptanal; enanthaldehyde.
Heptanal dimethyl acetal.
Heptanal 1,2-glyceryl acetal.
2,3-Heptanedione; acetyl valeryl.
3-Heptanol.
2-Heptanone; methyl amyl ketone.
3-Heptanone; ethyl butyl ketone.
4-Heptanone; dipropyl ketone.
cis-4-Heptenal; cis-4-hepten-1-al.
Heptyl acetate.
Heptyl alcohol; enanthic alcohol.
Heptyl butyrate.
Heptyl cinnamate.
Heptyl formate.
Heptyl isobutyrate.
Heptyl octanoate.
1-Hexadecanol; cetyl alcohol.
[omega]-6-Hexadecenlactone; 16-hydroxy-6-hexadecenoic acid, [omega]-
lactone; ambrettolide.
[gamma]-Hexalactone; 4-hydroxyhexanoic acid, [gamma]-lactone; tonkalide.
Hexanal; caproic aldehyde.
2,3-Hexanedione; acetyl butyryl.
Hexanoic acid; caproic acid.
2-Hexenal.
2-Hexen-1-ol.
3-Hexen-1-ol; leaf alcohol.
2-Hexen-1-yl acetate.
3-Hexenyl isovalerate.
3-Hexenyl 2-methylbutyrate.
3-Hexenyl phenylacetate; cis-3-hexenyl phenylacetate.
Hexyl acetate.
2-Hexyl-4-acetoxytetrahydrofuran.
Hexyl alcohol.
Hexyl butyrate.
[alpha]-Hexylcinnamaldehyde.
Hexyl formate.
Hexyl hexanoate.
2-Hexylidene cyclopentanone.
Hexyl isovalerate.
Hexyl 2-methylbutyrate.
Hexyl octanoate.
Hexyl phenylacetate; n-hexyl phenylacetate.
Hexyl propionate.
Hydroxycitronellal; 3,7-dimethyl-7-hydroxy-octanal.
Hydroxycitronellal diethyl acetal.
Hydroxycitronellal dimethyl acetal.
Hydroxycitronellal; 3,7-dimethyl-1,7-octanediol.
N-(4-Hydroxy-3-methoxybenzyl)-nonanamide; pelargonyl vanillylamide.
5-Hydroxy-4-octanone; butyroin.
4-(p-Hydroxyphenyl)-2-butanone; p-hydroxybenzyl acetone.
Indole.
[alpha]-Ionone; 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one.
[beta]-Ionone; 4-(2,6,6-trimethyl-1-cyclohexen-1-yl)-3-buten-2-one.
[alpha]-Irone; 4-(2,5,6,6-tetramethyl-2-cyclohexene-1-yl)-3-buten-2-one;
6-methylionone.
Isoamyl acetate.
Isoamyl acetoacetate.
Isoamyl alcohol; isopentyl alcohol; 3-methyl-1-butanol.
Isoamyl benzoate.
Isoamyl butyrate.
Isoamyl cinnamate.
Isoamyl formate.
Isoamyl 2-furanbutyrate; [alpha]-isoamyl furfurylpropionate.
Isoamyl 2-furanpropionate; [alpha]-isoamyl furfurylacetate.
Isoamyl hexanoate.
Isoamyl isobutyrate.
Isoamyl isovalerate.
Isoamyl laurate.
Isoamyl-2-methylbutyrate; isopentyl-2-methylbutyrate.
Isoamyl nonanoate.
Isoamyl octanoate.
[[Page 60]]
Isoamyl phenylacetate.
Isoamyl propionate.
Isoamyl pyruvate.
Isoamyl salicylate.
Isoborneol.
Isobornyl acetate.
Isobornyl formate.
Isobornyl isovalerate.
Isobornyl propionate.
Isobutyl acetate.
Isobutyl acetoacetate.
Isobutyl alcohol.
Isobutyl angelate; isobutyl cis-2-methyl-2-butenoate.
Isobutyl anthranilate.
Isobutyl benzoate.
Isobutyl butyrate.
Isobutyl cinnamate.
Isobutyl formate.
Isobutyl 2-furanpropionate.
Isobutyl heptanoate.
Isobutyl hexanoate.
Isobutyl isobutyrate.
[alpha]-Isobutylphenethyl alcohol; isobutyl benzyl carbinol; 4-methyl-1-
phenyl-2-pentanol.
Isobutyl phenylacetate.
Isobutyl propionate.
Isobutyl salicylate.
2-Isobutylthiazole.
Isobutyraldehyde.
Isobutyric acid.
Isoeugenol; 2-methoxy-4-propenylphenol.
Isoeugenyl acetate.
Isoeugenyl benzyl ether; benzyl isoeugenol.
Isoeugenyl ethyl ether; 2-ethoxy-5-propenyl-anisole; ethyl isoeugenol.
Isoeugenyl formate.
Isoeugenyl methyl ether; 4-propenylveratrole; methyl isoeugenol.
Isoeugenyl phenylacetate.
Isojasmone; mixture of 2-hexylidenecyclopentanone and 2-hexyl-2-
cyclopenten-1-one.
[alpha]-Isomethylionone; 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-methyl-
3-buten-2-one; methyl [gamma]-ionone.
Isopropyl acetate.
[rho]-Isopropylacetophenone.
Isopropyl alcohol; isopropanol.
Isopropyl benzoate.
[rho]-Isopropylbenzyl alcohol; cuminic alcohol; [rho]-cymen-7-ol.
Isopropyl butyrate.
Isopropyl cinnamate.
Isopropyl formate.
Isopropyl hexanoate.
Isopropyl isobutyrate.
Isopropyl isovalerate.
[rho]-Isopropylphenylacetaldehyde; [rho]-cymen-7-carboxaldehyde.
Isopropyl phenylacetate.
3-([rho]-Isopropylphenyl)-propionaldehyde; [rho]-
isopropylhydrocinnamaldehyde; cuminyl acetaldehyde.
Isopropyl propionate.
Isopulegol; p-menth-8-en-3-ol.
Isopulegone; p-menth-8-en-3-one.
Isopulegyl acetate.
Isoquinoline.
Isovaleric acid.
cis-Jasmone; 3-methyl-2-(2-pentenyl)-2-cyclopenten-1-one.
Lauric aldehyde; dodecanal.
Lauryl acetate.
Lauryl alcohol; 1-dodecanol.
Lepidine; 4-methylquinoline.
Levulinic acid.
Linalool oxide; cis- and trans-2-vinyl-2-methyl-5-(1'-hydroxy-1'-
methylethyl) tetrahydrofuran.
Linalyl anthranilate; 3,7-dimethyl-1,6-octadien-3-yl anthranilate.
Linalyl benzoate.
Linalyl butyrate.
Linalyl cinnamate.
Linalyl formate.
Linalyl hexanoate.
Linalyl isobutyrate.
Linalyl isovalerate.
Linalyl octanoate.
Linalyl propionate.
Maltol; 3-hydroxy-2-methyl-4H-pyran-4-one.
Menthadienol; p-mentha-1,8(10)-dien-9-ol.
p-Mentha-1,8-dien-7-ol; perillyl alcohol.
Menthadienyl acetate; p-mentha-1,8(10)-dien-9-yl acetate.
p-Menth-3-en-1-ol.
1-p-Menthen--9-yl acetate; p-menth-1-en-9-yl acetate.
Menthol; 2-isopropyl-5-methylcyclohexanol.
Menthone; p-menthan-3-one.
Menthyl acetate; p-menth-3-yl acetate.
Menthyl isovalerate; p-menth-3-yl isovalerate.
o-Methoxybenzaldehyde.
p-Methoxybenzaldehyde; p-anisaldehyde.
o-Methoxycinnamaldehyde.
2-Methoxy-4-methylphenol; 4-methylguaiacol; 2-methoxy-p-cresol.
4-(p-Methoxyphenyl)-2-butanone; anisyl acetone.
1-(4-Methoxyphenyl)-4-methyl-1-penten-3-one; methoxystyryl isopropyl
ketone.
1-(p-Methoxyphenyl)-1-penten-3-one; [alpha]-methylanisylidene acetone;
ethone.
1-(p-Methoxyphenyl)-2-propanone; anisylmethyl ketone; anisic ketone.
2-Methoxy-4-vinylphenol; p-vinylguaiacol.
Methyl acetate.
4'-Methylacetophenone; p-methylacetophenone; methyl p-tolyl ketone.
2-Methylallyl butyrate; 2-methyl-2-propenl-yl butyrate.
Methyl anisate.
o-Methylanisole; o-cresyl methyl ether.
p-Methylanisole; p-cresyl methyl ether; p-methoxytoluene.
Methyl benzoate.
Methylbenzyl acetate, mixed o-,m-,p-.
[alpha]-Methylbenzyl acetate; styralyl acetate.
[alpha]-Methylbenzyl alcohol; styralyl alcohol.
[alpha]-Methylbenzyl butyrate; styralyl butyrate.
[alpha]-Methylbenzyl isobutyrate; styralyl isobutyrate.
[alpha]-Methylbenzyl formate; styralyl formate.
[[Page 61]]
[alpha]-Methylbenzyl propionate; styralyl propionate.
2-Methyl-3-buten-2-ol.
2-Methylbutyl isovalerate.
Methyl p-tert-butylphenylacetate.
2-Methylbutyraldehyde; methyl ethyl acetaldehyde.
3-Methylbutyraldehyde; isovaleraldehyde.
Methyl butyrate.
2-Methylbutyric acid.
[alpha]-Methylcinnamaldehyde.
p-Methylcinnamaldehyde.
Methyl cinnamate.
2-Methyl-1,3-cyclohexadiene.
Methylcyclopentenolone; 3-methylcyclopentane-1,2-dione.
Methyl disulfide; dimethyl disulfide.
Methyl ester of rosin, partially hydrogenated (as defined in
Sec. 172.615); methyl dihydroabietate.
Methyl heptanoate.
2-Methylheptanoic acid.
6-Methyl-3,5-heptadien-2-one.
Methyl-5-hepten-2-ol.
6-Methyl-5-hepten-2-one.
Methyl hexanoate.
Methyl 2-hexanoate.
Methyl p-hydroxybenzoate; methylparaben.
Methyl [alpha]-ionone; 5-(2,6,6-trimethyl-2-cyclohexen-1-yl)-4-penten-3-
one.
Methyl [beta]-ionone; 5-(2,6,6-trimethyl-1-cyclohexen-1-yl)-4-penten-3-
one.
Methyl [Delta]-ionone; 5-(2,6,6-trimethyl-3-cyclohexen-1-yl-)-4-penten-
3-one.
Methyl isobutyrate.
2-Methyl-3-(p-isopropylphenyl)-propionalde-hyde; [alpha]-methyl-p-
isopropylhydro- cinnamal- dehyde; cyclamen aldehyde.
Methyl isovalerate.
Methyl laurate.
Methyl mercaptan; methanethiol.
Methyl o-methoxybenzoate.
Methyl N-methylanthranilate; dimethyl anthranilate.
Methyl 2-methylbutyrate.
Methyl-3-methylthiopropionate.
Methyl 4-methylvalerate.
Methyl myristate.
Methyl [beta]-naphthyl ketone; 2'-acetonaphthone.
Methyl nonanoate.
Methyl 2-nonenoate.
Methyl 2-nonynoate; methyloctyne carbonate.
2-Methyloctanal; methyl hexyl acetaldehyde.
Methyl octanoate.
Methyl 2-octynoate; methyl heptine carbonate.
4-Methyl-2,3-pentanedione; acetyl isobutyryl.
4-Methyl-2-pentanone; methyl isobutyl ketone.
[beta]-Methylphenethyl alcohol; hydratropyl alcohol.
Methyl phenylacetate.
3-Methyl-4-phenyl-3-butene-2-one.
2-Methyl-4-phenyl-2-butyl acetate; dimethylphenylethyl carbinyl acetate.
2-Methyl-4-phenyl-2-butyl isobutyrate; dimethylphenyl ethylcarbinyl
isobutyrate.
3-Methyl-2-phenylbutyraldehyde; [alpha]-isopropyl phenylacetaldehyde.
Methyl 4-phenylbutyrate.
4-Methyl-1-phenyl-2-pentanone; benzyl isobutyl ketone.
Methyl 3-phenylpropionate; methyl hydrocinnamate.
Methyl propionate.
3-Methyl-5-propyl-2-cyclohexen-1-one.
Methyl sulfide.
3-Methylthiopropionaldehyde; methional.
2-Methyl-3-tolylpropionaldehyde, mixed o-, m-, p-.
2-Methylundecanal; methyl nonyl acetaldehyde.
Methyl 9-undecenoate.
Methyl 2-undecynoate; methyl decyne carbonate.
Methyl valerate.
2-Methylvaleric acid.
Myrcene; 7-methyl-3-methylene-1,6-octadiene.
Myristaldehyde; tetradecanal.
d-Neomenthol; 2-isopropyl-5-methylcyclohexanol.
Nerol; cis-3,7-dimethyl-2,6-octadien-1-ol.
Nerolidol; 3,7,11-trimethyl-1,6,10-dodecatrien-3-ol.
Neryl acetate.
Neryl butyrate.
Neryl formate.
Neryl isobutyrate.
Neryl isovalerate.
Neryl propionate.
2,6-Nonadien-1-ol.
[gamma]-Nonalactone; 4-hydroxynonanoic acid, [gamma]-lactone; aldehyde
C-18.
Nonanal; pelargonic aldehyde.
1,3-Nonanediol acetate, mixed esters.
Nonanoic acid; pelargonic acid.
2-Nonanone; methylheptyl ketone.
3-Nonanon-1-yl acetate; 1-hydroxy-3-nonanone acetate.
Nonyl acetate.
Nonyl alcohol; 1-nonanol.
Nonyl octanoate.
Nonyl isovalerate.
Nootkatone; 5,6-dimethyl-8-isopropenyl-bicyclo[4,4,0]-dec-1-en-3-one.
Ocimene; trans-[beta]-ocimene; 3,7-dimethyl-1,3,6-octatriene.
[gamma]-Octalactone; 4-hydroxyoctanoic acid, [gamma]-lactone.
Octanal; caprylaldehyde.
Octanal dimethyl acetal.
1-Octanol; octyl alcohol.
2-Octanol.
3-Octanol.
2-Octanone; methyl hexyl ketone.
3-Octanone; ethyl amyl ketone.
3-Octanon-1-ol.
1-Octen-3-ol; amyl vinyl carbinol.
1-Octen-3-yl acetate.
[[Page 62]]
Octyl acetate.
3-Octyl acetate.
Octyl butyrate.
Octyl formate.
Octyl heptanoate.
Octyl isobutyrate.
Octyl isovalerate.
Octyl octanoate.
Octyl phenylacetate.
Octyl propionate.
[omega]-Pentadecalactone; 15-hydroxypentadeca-noic acid, [omega]-
lactone; pentadecanolide; angelica lactone.
2,3-Pentanedione; acetyl propionyl.
2-Pentanone; methyl propyl ketone.
4-Pentenoic acid.
1-Penten-3-ol.
Perillaldehyde; 4-isopropenyl-1-cyclohexene-1-carboxaldehyde;p-mentha-
1,8-dien-7-al.
Perillyl acetate; p-mentha-1,8-dien-7-yl acetate.
[alpha]-Phellandrene; [rho]-mentha-1,5-diene.
Phenethyl acetate.
Phenethyl alcohol; [beta]-phenylethyl alcohol.
Phenethyl anthranilate.
Phenethyl benzoate.
Phenethyl butyrate.
Phenethyl cinnamate.
Phenethyl formate.
Phenethyl isobutyrate.
Phenethyl isovalerate.
Phenethyl 2-methylbutyrate.
Phenethyl phenylacetate.
Phenethyl propionate.
Phenethyl salicylate.
Phenethyl senecioate; phenethyl 3,3-dimethylacrylate.
Phenethyl tiglate.
Phenoxyacetic acid.
2-Phenoxyethyl isobutyrate.
Phenylacetaldehyde; [alpha]-toluic aldehyde.
Phenylacetaldehyde 2,3-butylene glycol acetal.
Phenylacetaldehyde dimethyl acetal.
Phenylacetaldehyde glyceryl acetal.
Phenylacetic acid; [alpha]-toluic acid.
4-Phenyl-2-butanol; phenylethyl methyl carbinol.
4-Phenyl-3-buten-2-ol; methyl styryl carbinol.
4-Phenyl-3-buten-2-one.
4-Phenyl-2-butyl acetate; phenylethyl methyl carbinyl acetate.
1-Phenyl-3-methyl-3-pentanol; phenylethyl methyl ethyl carbinol.
1-Phenyl-1-propanol; phenylethyl carbinol.
3-Phenyl-1-propanol; hydrocinnamyl alcohol.
2-Phenylpropionaldehyde; hydratropalde-hyde.
3-Phenylpropionaldehyde; hydrocinnamaldehyde.
2-Phenylpropionalde-hyde dimethyl acetal; hydratropic aldehyde dimethyl
acetal.
3-Phenylpropionic acid; hydrocinnamic acid.
3-Phenylpropyl acetate.
2-Phenylpropyl butyrate.
3-Phenylpropyl cinnamate.
3-Phenylpropyl formate.
3-Phenylpropyl hexanoate.
2-Phenylpropyl isobutyrate.
3-Phenylpropyl isobutyrate.
3-Phenylpropyl isovalerate.
3-Phenylpropyl propionate.
2-(3-Phenylpropyl)-tetrahydrofuran.
[alpha]-Pinene; 2-pinene.
[beta]-Pinene; 2(10)-pinene.
Pine tar oil.
Pinocarveol; 2(10)-pinen-3-ol.
Piperidine.
Piperine.
d-Piperitone; p-menth-1-en-3-one.
Piperitenone; p-mentha-1,4(8)-dien-3-one.
Piperitenone oxide; 1,2-epoxy-p-menth-4-(8)-en-3-one.
Piperonyl acetate; heliotropyl acetate.
Piperonyl isobutyrate.
Polylimonene.
Polysorbate 20; polyoxyethylene (20) sorbitan monolaurate.
Polysorbate 60; polyoxyethylene (20) sorbitan monostereate.
Polysorbate 80; polyoxyethylene (20) sorbitan monooleate.
Potassium acetate.
Propenylguaethol; 6-ethoxy-m-anol.
Propionaldehyde.
Propyl acetate.
Propyl alcohol; 1-propanol.
p-Propyl anisole; dihydroanethole.
Propyl benzoate.
Propyl butyrate.
Propyl cinnamate.
Propyl disulfide.
Propyl formate.
Propyl 2-furanacrylate.
Propyl heptanoate.
Propyl hexanoate.
Propyl p-hydroxybenzoate; propylparaben.
3-Propylidenephthalide.
Propyl isobutyrate.
Propyl isovalerate.
Propyl mercaptan.
[alpha]-Propylphenethyl alcohol.
Propyl phenylacetate.
Propyl propionate.
Pulegone; p-menth-4(8)-en-3-one.
Pyridine.
Pyroligneous acid extract.
Pyruvaldehyde.
Pyruvic acid.
Rhodinol; 3,7-dimethyl-7-octen-1-ol; l-citronellol.
Rhodinyl acetate.
Rhodinyl butyrate.
Rhodinyl formate.
Rhodinyl isobutyrate.
Rhodinyl isovalerate.
Rhodinyl phenylacetate.
Rhodinyl propionate.
Rum ether; ethyl oxyhydrate.
Salicylaldehyde.
Santalol, [alpha] and [beta].
Santalyl acetate.
Santalyl phenylacetate.
[[Page 63]]
Skatole.
Sorbitan monostearate.
Styrene.
Sucrose octaacetate.
[alpha]-Terpinene.
[gamma]-Terpinene.
[alpha]-Terpineol; p-menth-1-en-8-ol.
[beta]-Terpineol.
Terpinolene; p-menth-1,4(8)-diene.
Terpinyl acetate.
Terpinyl anthranilate.
Terpinyl butyrate.
Terpinyl cinnamate.
Terpinyl formate.
Terpinyl isobutyrate.
Terpinyl isovalerate.
Terpinyl propionate.
Tetrahydrofurfuryl acetate.
Tetrahydrofurfuryl alcohol.
Tetrahydrofurfuryl butyrate.
Tetrahydrofurfuryl propionate.
Tetrahydro-pseudo-ionone; 6,10-dimethyl-9-undecen-2-one.
Tetrahydrolinalool; 3,7-dimethyloctan-3-ol.
Tetramethyl ethylcyclohexenone; mixture of 5-ethyl-2,3,4,5-tetramethyl-
2-cyclohexen-1-one and 5-ethyl-3,4,5,6-tetramethyl-2-cyclohexen-1-one.
2-Thienyl mercaptan; 2-thienylthiol.
Thymol.
Tolualdehyde glyceryl acetal, mixed o, m, p.
Tolualdehydes, mixed o, m, p.
p-Tolylacetaldehyde.
o-Tolyl acetate; o-cresyl acetate.
p-Tolyl acetate; p-cresyl acetate.
4-(p-Tolyl)-2-butanone; p-methylbenzylacetone.
p-Tolyl isobutyrate.
p-Tolyl laurate.
p-Tolyl phenylacetate.
2-(p-Tolyl)-propionaldehyde; p-methylhydratropic aldehyde.
Tributyl acetylcitrate.
2-Tridecenal.
2,3-Undecadione; acetyl nonyryl.
[gamma]-Undecalactone; 4-hydroxyundecanoic acid [gamma]-lactone; peach
aldehyde; aldehyde C-14.
Undecenal.
2-Undecanone; methyl nonyl ketone.
9-Undecenal; undecenoic aldehyde.
10-Undecenal.
Undecen-1-ol; undecylenic alcohol.
10-Undecen-1-yl acetate.
Undecyl alcohol.
Valeraldehyde; pentanal.
Valeric acid; pentanoic acid.
Vanillin acetate; acetyl vanillin.
Veratraldehyde.
Verbenol; 2-pinen-4-ol.
Zingerone; 4-(4-hydroxy-3-methoxyphenyl)-2-butanone.
(c) [Delta]-Decalactone and [Delta]-dodecalactone when used
separately or in combination in oleomargarine are used at levels not to
exceed 10 parts per million and 20 parts per million, respectively, in
accordance with Sec. 166.110 of this chapter.
(d) BHA (butylated hydroxyanisole) may be used as an antioxidant in
flavoring substances whereby the additive does not exceed 0.5 percent of
the essential (volatile) oil content of the flavoring substance.
[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 23148, May 6, 1977; 43
FR 19843, May 9, 1978; 45 FR 22915, Apr. 4, 1980; 47 FR 27810, June 25,
1982; 48 FR 10812, Mar. 15, 1983; 48 FR 51907, Nov. 15, 1983; 49 FR
5747, Feb. 15, 1984; 50 FR 42932, Oct. 23, 1985; 54 FR 7402, Feb. 21,
1989; 61 FR 14245, Apr. 1, 1996]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.520]
[Page 63]
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 F--Flavoring Agents and Related Substances
Sec. 172.520 Cocoa with dioctyl sodium sulfosuccinate for manufacturing.
The food additive "cocoa with dioctyl sodium sulfosuccinate for
manufacturing," conforming to Sec. 163.117 of this chapter and
Sec. 172.810, is used or intended for use as a flavoring substance in
dry beverage mixes whereby the amount of dioctyl sodium sulfosuccinate
does not exceed 75 parts per million of the finished beverage. The
labeling of the dry beverage mix shall bear adequate directions to
assure use in compliance with this section.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.530]
[Page 63]
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 F--Flavoring Agents and Related Substances
Sec. 172.530 Disodium guanylate.
Disodium guanylate may be safely used as a flavor enhancer in foods,
at a level not in excess of that reasonably required to produce the
intended effect.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.535]
[Page 63]
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 F--Flavoring Agents and Related Substances
Sec. 172.535 Disodium inosinate.
The food additive disodium inosinate may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive is the disodium salt of inosinic acid,
manufactured and purified so as to contain no more than 150 parts per
million of soluble barium in the compound disodium inosinate with seven
and one-half molecules of water of crystallization.
(b) The food additive is used as a flavoring adjuvant in food.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.540]
[Page 63-64]
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 F--Flavoring Agents and Related Substances
Sec. 172.540 DL-Alanine.
DL-Alanine (a racemic mixture of D- and L-alanine; CAS Reg. No. 302-
72-7) may be safely used as a flavor enhancer for sweeteners in pickling
mixtures at a level not to exceed 1 percent of the
[[Page 64]]
pickling spice that is added to the pickling brine.
[56 FR 6968, Feb. 21, 1991]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.560]
[Page 64-65]
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 F--Flavoring Agents and Related Substances
Sec. 172.560 Modified hop extract.
The food additive modified hop extract may be safely used in beer in
accordance with the following prescribed conditions:
(a) The food additive is used or intended for use as a flavoring
agent in the brewing of beer.
(b) The food additive is manufactured by one of the following
processes:
(1) The additive is manufactured from a hexane extract of hops by
simultaneous isomerization and selective reduction in an alkaline
aqueous medium with sodium borohydride, whereby the additive meets the
following specifications:
(i) A solution of the food additive solids is made up in
approximately 0.012 n alkaline methyl alcohol (6 milliliters of 1 n
sodium hydroxide diluted to 500 milliliters with methyl alcohol) to show
an absorbance at 253 millimicrons of 0.6 to 0.9 per centimeter. (This
absorbance is obtained by approximately 0.03 milligram solids
permilliliter.) The ultraviolet absorption spectrum of this solution
exhibits the following characteristics: An absorption peak at 253
millimicrons; no absorption peak at 325 to 330 millimicrons; the
absorbance at 268 millimicrons does not exceed the absorbance at 272
millimicrons.
(ii) The boron content of the food additive does not exceed 310
parts per million (0.0310 percent), calculated as boron.
(2) The additive is manufactured from hops by a sequence of
extractions and fractionations, using benzene, light petroleum spirits,
and methyl alcohol as solvents, followed by isomerization by potassium
carbonate treatment. Residues of solvents in the modified hop extract
shall not exceed 1.0 part per million of benzene, 1.0 part per million
of light petroleum spirits, and 250 parts per million of methyl alcohol.
The light petroleum spirits and benzene solvents shall comply with the
specifications in Sec. 172.250 except that the boiling point range for
light petroleum spirits is 150 deg.F-300 deg.F.
(3) The additive is manufactured from hops by a sequence of
extractions and fractionations, using methylene chloride, hexane, and
methyl alcohol as solvents, followed by isomerization by sodium
hydroxide treatment. Residues of the solvents in the modified hop
extract shall not exceed 5 parts per million of methylene chloride, 25
parts per million of hexane, and 100 parts per million of methyl
alcohol.
(4) The additive is manufactured from hops by a sequence of
extractions and fractionations, using benzene, light petroleum spirits,
methyl alcohol, n-butyl alcohol, and ethyl acetate as solvents, followed
by isomerization by potassium carbonate treatment. Residues of solvents
in the modified hop extract shall not exceed 1.0 part per million of
benzene, 1.0 part per million of light petroleum spirits, 50 parts per
million of methyl alcohol, 50 parts per million of n-butyl alcohol, and
1 part per million of ethyl acetate. The light petroleum spirits and
benzene solvents shall comply with the specifications in Sec. 172.250
except that the boiling point range for light petroleum spirits is 150
deg.F to 300 deg.F.
(5) The additive is manufactured from hops by an initial extraction
and fractionation using one or more of the following solvents: Ethylene
dichloride, hexane, isopropyl alcohol, methyl alcohol, methylene
chloride, trichloroethylene, and water; followed by isomerization by
calcium chloride or magnesium chloride treatment in ethylene dichloride,
methylene chloride, or trichloroethylene and a further sequence of
extractions and fractionations using one or more of the solvents set
forth in this paragraph. Residues of the solvents in the modified hop
extract shall not exceed 125 parts per million of hexane; 150 parts per
million of ethylene dichloride, methylene chloride, or
trichloroethylene; or 250 parts per million of isopropyl alcohol or
methyl alcohol.
(6) The additive is manufactured from hops by an initial extraction
and fractionation using one or more of the solvents listed in paragraph
(b)(5) of this section followed by: Hydrogenation using palladium as a
catalyst in methyl alcohol, ethyl alcohol, or isopropyl alcohol
acidified with hydrochloric or sulfuric acid; oxidation with
[[Page 65]]
peracetic acid; isomerization by calcium chloride or magnesium chloride
treatment in ethylene dichloride, methylene chloride, or
trichloroethylene (alternatively, the hydrogenation and isomerization
steps may be performed in reverse order); and a further sequence of
extractions and fractionations using one or more of the solvents listed
in paragraph (b)(5) of this section. The additive shall meet the residue
limitations as prescribed in paragraph (b)(5) of this section.
(7) The additive is manufactured from hops as set forth in paragraph
(b)(6) of this section followed by reduction with sodium borohydride in
aqueous alkaline methyl alcohol, and a sequence of extractions and
fractionations using one or more of the solvents listed in paragraph
(b)(5) of this section. The additive shall meet the residue limitations
as prescribed in paragraph (b)(5) of this section, and a boron content
level not in excess of 300 parts per million (0.0300 percent),
calculated as boron.
(8) The additive is manufactured from hops as a nonisomerizable
nonvolatile hop resin by an initial extraction and fractionation using
one or more of the solvents listed in paragraph (b)(5) of this section
followed by a sequence of aqueous extractions and removal of nonaqueous
solvents to less than 0.5 percent. The additive is added to the wort
before or during cooking in the manufacture of beer.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.575]
[Page 65]
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 F--Flavoring Agents and Related Substances
Sec. 172.575 Quinine.
Quinine, as the hydrochloride salt or sulfate salt, may be safely
used in food in accordance with the following conditions:
------------------------------------------------------------------------
Uses Limitations
------------------------------------------------------------------------
In carbonated beverages as a flavor..... Not to exceed 83 parts per
million, as quinine. Label
shall bear a prominent
declaration of the presence
of quinine either by the use
of the word "quinine" in
the name of the article or
through a separate
declaration.
------------------------------------------------------------------------
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.580]
[Page 65]
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 F--Flavoring Agents and Related Substances
Sec. 172.580 Safrole-free extract of sassafras.
The food additive safrole-free extract of sassafras may be safely
used in accordance with the following prescribed conditions:
(a) The additive is the aqueous extract obtained from the root bark
of the plant Sassafras albidum (Nuttall) Nees (Fam. Lauraceae).
(b) It is obtained by extracting the bark with dilute alcohol, first
concentrating the alcoholic solution by vacuum distillation, then
diluting the concentrate with water and discarding the oily fraction.
(c) The purified aqueous extract is safrole-free.
(d) It is used as a flavoring in food.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.585]
[Page 65]
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 F--Flavoring Agents and Related Substances
Sec. 172.585 Sugar beet extract flavor base.
Sugar beet extract flavor base may be safely used in food in
accordance with the provisions of this section.
(a) Sugar beet extract flavor base is the concentrated residue of
soluble sugar beet extractives from which sugar and glutamic acid have
been recovered, and which has been subjected to ion exchange to minimize
the concentration of naturally occurring trace minerals.
(b) It is used as a flavor in food.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.590]
[Page 65]
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 F--Flavoring Agents and Related Substances
Sec. 172.590 Yeast-malt sprout extract.
Yeast-malt sprout extract, as described in this section, may be
safely used in food in accordance with the following prescribed
conditions:
(a) The additive is produced by partial hydrolysis of yeast extract
(derived from Saccharomyces cereviseae, Saccharomyces fragilis, or
Candida utilis) using the sprout portion of malt barley as the source of
enzymes. The additive contains a maximum of 6 percent 5' nucleotides by
weight.
(b) The additive may be used as a flavor enhancer in food at a level
not in excess of that reasonably required to produce the intended
effect.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.610]
[Page 65-66]
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 G--Gums, Chewing Gum Bases and Related Substances
Sec. 172.610 Arabinogalactan.
Arabinogalactan may be safely used in food in accordance with the
following conditions:
(a) Arabinogalactan is a polysaccharide extracted by water from
Western larch wood, having galactose units and arabinose units in the
approximate ratio of six to one.
[[Page 66]]
(b) It is used in the following foods in the minimum quantity
required to produce its intended effect as an emulsifier, stabilizer,
binder, or bodying agent: Essential oils, nonnutritive sweeteners,
flavor bases, nonstandardized dressings, and pudding mixes.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.615]
[Page 66-67]
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 G--Gums, Chewing Gum Bases and Related Substances
Sec. 172.615 Chewing gum base.
The food additive chewing gum base may be safely used in the
manufacture of chewing gum in accordance with the following prescribed
conditions:
(a) The food additive consists of one or more of the following
substances that meet the specifications and limitations prescribed in
this paragraph, used in amounts not to exceed those required to produce
the intended physical or other technical effect.
Masticatory Substances
natural (coagulated or concentrated latices) of vegetable origin
------------------------------------------------------------------------
Family Genus and species
------------------------------------------------------------------------
Sapotaceae:
Chicle....................... Manilkara zapotilla Gilly and Manilkara
chicle Gilly.
Chiquibul.................... Manilkara zapotilla Gilly.
Crown gum.................... Manilkara zapotilla Gilly and Manilkara
chicle Gilly.
Gutta hang kang.............. Palaquium leiocarpum Boerl. and
Palaquium oblongifolium Burck.
Massaranduba balata (and the Manilkara huberi (Ducke) Chevalier.
solvent-free resin extract
of Massaranduba balata).
Massaranduba chocolate....... Manilkara solimoesensis Gilly.
Nispero...................... Manilkara zapotilla Gilly and Manilkara
chicle Gilly.
Rosidinha (rosadinha)........ Micropholis (also known as Sideroxylon)
spp.
Venezuelan chicle............ Manilkara williamsii Standley and
related spp.
Apocynaceae:
Jelutong..................... Dyera costulata Hook, F. and Dyera
lowii Hook, F.
Leche caspi (sorva).......... Couma macrocarpa Barb. Rodr.
Pendare...................... Couma macrocarpa Barb. Rodr. and Couma
utilis (Mart.) Muell. Arg.
Perillo...................... Couma macrocarpa Barb. Rodr. and Couma
utilis (Mart.) Muell. Arg.
Moraceae:
Leche de vaca................ Brosimum utile (H.B.K.) Pittier and
Poulsenia spp.; also Lacmellea
standleyi (Woodson), Monachino
(Apocynaceae).
Niger gutta.................. Ficus platyphylla Del.
Tunu (tuno).................. Castilla fallax Cook.
Euphorbiaceae:
Chilte....................... Cnidoscolus (also known as Jatropha)
elasticus Lundell and Cnidoscolus
tepiquensis (Cost. and Gall.) McVaugh.
Natural rubber (smoked sheet Hevea brasiliensis.
and latex solids).
------------------------------------------------------------------------
Synthetic Specifications
------------------------------------------------------------------------
Butadiene-styrene rubber..... Basic polymer.
Isobutylene-isoprene Do.
copolymer (butyl rubber).
Paraffin....................... Synthesized by Fischer-Tropsch process
from carbon monoxide and hydrogen
which are catalytically converted to a
mixture of paraffin hydrocarbon. Lower
molecular weight fractions are removed
by distillation. The residue is
hydrogenated and further treated by
percolation through activated
charcoal. The product has a congealing
point of 93 deg.-99 deg.C as
determined by ASTM method D938-71
(Reapproved 1981), "Standard Test
Method for Congealing Point of
Petroleum Waxes, Including
Petrolatum," a maximum oil content of
0.5 percent as determined by ASTM
method D721-56T, "Tentative Method of
Test for Oil Content of Petroleum
Waxes," and an absorptivity of less
than 0.01 at 290 millimicrons in
decahydronaphthalene at 88 deg.C as
determined by ASTM method D2008-80,
"Standard Test Method for Ultraviolet
Absorbance and Absorptivity of
Petroleum Products," which are
incorporated by reference. Copies may
be obtained from the American Society
for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be
examined at the Office of the Federal
Register, 800 North Capitol Street,
NW., suite 700, Washington, DC 20408.
Petroleum wax................ Complying with Sec. 172.886.
Petroleum wax synthetic...... Complying with Sec. 172.888.
Polyethylene................. Molecular weight 2,000-21,000.
Polyisobutylene.............. Minimum molecular weight 37,000
(Flory).
Polyvinyl acetate............ Molecular weight, minimum 2,000.
------------------------------------------------------------------------
[[Page 67]]
Plasticizing Materials (Softeners)
------------------------------------------------------------------------
Glycerol ester of partially Having an acid number of 3-8, a minimum
dimerized rosin. drop-softening point of 109 deg.C,
and a color of M or paler.
Glycerol ester of partially Having an acid number of 3-10, a
hydrogenated gum or wood rosin. minimum drop-softening point of 79
deg.C, and a color of N or paler.
Glycerol ester of polymerized Having an acid number of 3-12, a
rosin. minimum melting-point of 80 deg.C,
and a color of M or paler.
Glycerol ester of gum rosin.... Having an acid number of 5-9, a minimum
drop-softening point of 88 deg.C, and
a color of N or paler. The ester is
purified by steam stripping.
Glycerol ester of tall oil Having an acid number of 2-12, a
rosin. softening point (ring and ball) of 80
deg.-88 deg.C, and a color of N or
paler. The ester is purified by steam
stripping.
Glycerol ester of wood rosin... Having an acid number of 3-9, a drop-
softening point of 88 deg.C-96
deg.C, and a color of N or paler. The
ester is purified by steam stripping.
Lanolin........................ .......................................
Methyl ester of rosin, Having an acid number of 4-8, a
partially hydrogenated. refractive index of 1.5170-1.5205 at
20 deg.C, and a viscosity of 23-66
poises at 25 deg.C. The ester is
purified by steam stripping.
Pentaerythritol ester of Having an acid number of 7-18, a
partially hydrogenated gum or minimum drop-softening point of 102
wood rosin. deg.C, and a color of K or paler.
Pentaerythritol ester of gum or Having an acid number of 6-16, a
wood rosin. minimum drop-softening point of 109
deg.C, and a color of M or paler.
Rice bran wax.................. Complying with Sec. 172.890.
Stearic acid................... Complying with Sec. 172.860.
Sodium and potassium stearates. Complying with Sec. 172.863.
------------------------------------------------------------------------
Terpene Resins
------------------------------------------------------------------------
Synthetic resin................ Consisting of polymers of
[alpha]pinene, [beta]pinene, and/or
dipentene; acid value less than 5,
saponification number less than 5, and
color less than 4 on the Gardner scale
as measured in 50 percent mineral
spirit solution.
Natural resin.................. Consisting of polymers of [alpha]-
pinene; softening point minimum 155
deg.C, determined by U.S.P. closed-
capillary method, United States
Pharmacopeia XX (1980) (page 961).
------------------------------------------------------------------------
Antioxidants
------------------------------------------------------------------------
Butylated hydroxyanisole....... Not to exceed antioxidant content of
0.1% when used alone or in any
combination.
Butylated hydroxytoluene....... Do.
Propyl gallate................. Do.
------------------------------------------------------------------------
Miscellaneous
------------------------------------------------------------------------
Sodium sulfate................. .......................................
Sodium sulfide................. Reaction-control agent in synthetic
polymer production.
------------------------------------------------------------------------
(b) In addition to the substances listed in paragraph (a) of this
section, chewing gum base may also include substances generally
recognized as safe in food.
(c) To assure safe use of the additive, in addition to the other
information required by the act, the label and labeling of the food
additive shall bear the name of the additive, "chewing gum base." As
used in this paragraph, the term "chewing gum base" means the
manufactured or partially manufactured nonnutritive masticatory
substance comprised of one or more of the ingredients named and so
defined in paragraph (a) of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 45 FR 56051, Aug. 22, 1980;
49 FR 5747, Feb. 15, 1984; 49 FR 10105, Mar. 19, 1984; 66 FR 38153, July
23, 2001; 66 FR 53711, Oct. 24, 2001]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.620]
[Page 67-68]
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 G--Gums, Chewing Gum Bases and Related Substances
Sec. 172.620 Carrageenan.
The food additive carrageenan may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive is the refined hydrocolloid prepared by
aqueous extraction from the following members of
[[Page 68]]
the families Gigartinaceae and Solieriaceae of the class Rodophyceae
(red seaweed):
Chondrus crispus.
Chondrus ocellatus.
Eucheuma cottonii.
Eucheuma spinosum.
Gigartina acicularis.
Gigartina pistillata.
Gigartina radula.
Gigartina stellata.
(b) The food additive conforms to the following conditions:
(1) It is a sulfated polysaccharide the dominant hexose units of
which are galactose and anhydrogalactose.
(2) Range of sulfate content: 20 percent to 40 percent on a dry-
weight basis.
(c) The food additive is used or intended for use in the amount
necessary for an emulsifier, stabilizer, or thickener in foods, except
for those standardized foods that do not provide for such use.
(d) To assure safe use of the additive, the label and labeling of
the additive shall bear the name of the additive, carrageenan.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.623]
[Page 68]
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 G--Gums, Chewing Gum Bases and Related Substances
Sec. 172.623 Carrageenan with polysorbate 80.
Carrageenan otherwise meeting the definition and specifications of
Sec. 172.620 (a) and (b) and salts of carrageenan otherwise meeting the
definition of Sec. 172.626(a) may be safely produced with the use of
polysorbate 80 meeting the specifications and requirements of
Sec. 172.840 (a) and (b) in accordance with the following prescribed
conditions:
(a) The polysorbate 80 is used only to facilitate separation of
sheeted carrageenan and salts of carrageenan from drying rolls.
(b) The carrageenan and salts of carrageenan contain not more than 5
percent by weight of polysorbate 80, and the final food containing the
additives contains polysorbate 80 in an amount not to exceed 500 parts
per million.
(c) The carrageenan and salts of carrageenan so produced are used
only in producing foods in gel form and only for the purposes defined in
Secs. 172.620(c) and 172.626(b), respectively.
(d) The carrageenan and salts of carrageenan so produced are not
used in foods for which standards of identity exist unless the standards
provide for the use of carrageenan, or salts of carrageenan, combined
with polysorbate 80.
(e) The carrageenan and salts of carrageenan produced in accordance
with this section, and foods containing the same, in addition to the
other requirements of the Act, are labeled to show the presence of
polysorbate 80, and the label or labeling of the carrageenan and salts
of carrageenan so produced bear adequate directions for use.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.626]
[Page 68]
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 G--Gums, Chewing Gum Bases and Related Substances
Sec. 172.626 Salts of carrageenan.
The food additive salts of carrageenan may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive consists of carrageenan, meeting the
provisions of Sec. 172.620, modified by increasing the concentration of
one of the naturally occurring salts (ammonium, calcium, potassium, or
sodium) of carrageenan to the level that it is the dominant salt in the
additive.
(b) The food additive is used or intended for use in the amount
necessary for an emulsifier, stabilizer, or thickener in foods, except
for those standardized foods that do not provide for such use.
(c) To assure safe use of the additive, the label and labeling of
the additive shall bear the name of the salt of carrageenan that
dominates the mixture by reason of the modification, e.g., "sodium
carrageenan", "potassium carrageenan", etc.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.655]
[Page 68-69]
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 G--Gums, Chewing Gum Bases and Related Substances
Sec. 172.655 Furcelleran.
The food additive furcelleran may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive is the refined hydrocolloid prepared by
aqueous extraction of furcellaria fastigiata of the class Rodophyceae
(red seaweed).
(b) The food additive conforms to the following:
(1) It is a sulfated polysaccharide the dominant hexose units of
which are galactose and anhydrogalactose.
(2) Range of sulfate content: 8 percent to 19 percent, on a dry-
weight basis.
(c) The food additive is used or intended for use in the amount
necessary
[[Page 69]]
for an emulsifier, stabilizer, or thickener in foods, except for those
standardized foods that do not provide for such use.
(d) To assure safe use of the additive, the label and labeling of
the additive shall bear the name of the additive, furcelleran.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.660]
[Page 69]
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 G--Gums, Chewing Gum Bases and Related Substances
Sec. 172.660 Salts of furcelleran.
The food additive salts of furcelleran may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive consists of furcelleran, meeting the
provisions of Sec. 172.655, modified by increasing the concentration of
one of the naturally occurring salts (ammonium, calcium, potassium, or
sodium) of furcelleran to the level that it is the dominant salt in the
additive.
(b) The food additive is used or intended for use in the amount
necessary for an emulsifier, stabilizer, or thickener in foods, except
for those standardized foods that do not provide for such use.
(c) To assure safe use of the additive, the label and labeling of
the additive shall bear the name of the salt of furcelleran that
dominates the mixture by reason of the modification, e.g., "sodium
furcelleran", "potassium furcelleran", etc.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.665]
[Page 69-70]
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 G--Gums, Chewing Gum Bases and Related Substances
Sec. 172.665 Gellan gum.
The food additive gellan gum may be safely used in food in
accordance with the following prescribed conditions:
(a) The additive is a high molecular weight polysaccharide gum
produced from Pseudomonas elodea by a pure culture fermentation process
and purified by recovery with isopropyl alcohol. It is composed of
tetrasaccharide repeat units, each containing one molecule of rhamnose
and glucuronic acid, and two molecules of glucose. The glucuronic acid
is neutralized to a mixed potassium, sodium, calcium, and magnesium
salt. The polysaccharide may contain acyl (glyceryl and acetyl) groups
as the O-glycosidically linked esters.
(b) The strain of P. elodea is nonpathogenic and nontoxic in man and
animals.
(c) The additive is produced by a process that renders it free of
viable cells of P. elodea.
(d) The additive meets the following specifications:
(1) Positive for gellan gum when subjected to the following
identification tests:
(i) A 1-percent solution is made by hydrating 1 gram of gellan gum
in 99 milliliters of distilled water. The mixture is stirred for about 2
hours, using a motorized stirrer and a propeller-type stirring blade. A
small amount of the above solution is drawn into a wide bore pipet and
transferred into a solution of 10-percent calcium chloride. A tough
worm-like gel will form instantly.
(ii) To the 1-percent distilled water solution prepared for
identification test (i), 0.50 gram of sodium chloride is added. The
solution is heated to 80 deg.C with stirring, held at 80 deg.C for 1
minute, and allowed to cool to room temperature without stirring. A firm
gel will form.
(2) Residual isopropyl alcohol (IPA) not to exceed 0.075 percent as
determined by the procedure described in the Xanthan Gum monograph, the
"Food Chemicals Codex," 4th ed. (1996), pp. 437-438, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the National Academy Press, Box 285,
2101 Constitution Ave. NW., Washington, DC 20055 (Internet address
"http://www.nap.edu"), or 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 Office of the
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(e) The additive is used or intended for use in accordance with
current good manufacturing practice as a stabilizer and thickener as
defined in Sec. 170.3(o)(28) of this chapter. The additive may be used
in foods where standards of identity established under section 401 of
the Federal Food, Drug, and Cosmetic Act do not preclude such use.
(f) To assure safe use of the additive:
(1) The label of its container shall bear, in addition to other
information required by the Federal Food, Drug,
[[Page 70]]
and Cosmetic Act, the name of the additive and the designation "food
grade".
(2) The label or labeling of the food additive container shall bear
adequate directions for use.
[55 FR 39614, Sept. 28, 1990, as amended at 57 FR 55445, Nov. 25, 1992;
64 FR 1758, Jan. 12, 1999]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.695]
[Page 70-71]
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 G--Gums, Chewing Gum Bases and Related Substances
Sec. 172.695 Xanthan gum.
The food additive xanthan gum may be safely used in food in
accordance with the following prescribed conditions:
(a) The additive is a polysaccharide gum derived from Xanthomonas
campestris by a pure-culture fermentation process and purified by
recovery with isopropyl alcohol. It contains D-glucose, D-mannose, and
D-glucuronic acid as the dominant hexose units and is manufactured as
the sodium, potassium, or calcium salt.
(b) The strain of Xanthomonas campestris is nonpathogenic and
nontoxic in man or other animals.
(c) The additive is produced by a process that renders it free of
viable cells of Xanthomonas campestris.
(d) The additive meets the following specifications:
(1) Residual isopropyl alcohol not to exceed 750 parts per million.
(2) An aqueous solution containing 1 percent of the additive and 1
percent of potassium chloride stirred for 2 hours has a minimum
viscosity of 600 centipoises at 75 deg.F, as determined by Brookfield
Viscometer, Model LVF (or equivalent), using a No. 3 spindle at 60
r.p.m., and the ratio of viscosities at 75 deg.F and 150 deg.F is in
the range of 1.02 to 1.45.
(3) Positive for xanthan gum when subjected to the following
procedure:
Locust Bean Gum Gel Test
Blend on a weighing paper or in a weighing pan 1.0 gram of powdered
locust bean gum with 1.0 gram of the powdered polysaccharide to be
tested. Add the blend slowly (approximately \1/2\ minute) at the point
of maximum agitation to a stirred solution of 200 milliliters of
distilled water previously heated to 80 deg.C in a 400-milliliter
beaker. Continue mechanical stirring until the mixture is in solution,
but stir for a minimum time of 30 minutes. Do not allow the water
temperature to drop below 60 deg.C.
Set the beaker and its contents aside to cool in the absence of
agitation. Allow a minimum time of 2 hours for cooling. Examine the
cooled beaker contents for a firm rubbery gel formation after the
temperature drops below 40 deg.C.
In the event that a gel is obtained, make up a 1 percent solution of
the polysaccharide to be tested in 200 milliliters of distilled water
previously heated to 80 deg.C (omit the locust bean gum). Allow the
solution to cool without agitation as before. Formation of a gel on
cooling indicates that the sample is a gelling polysaccharide and not
xanthan gum.
Record the sample as "positive" for xanthan gum if a firm, rubbery
gel forms in the presence of locust bean gum but not in its absence.
Record the sample as "negative" for xanthan gum if no gel forms or if
a soft or brittle gel forms both with locust bean gum and in a 1 percent
solution of the sample (containing no locust bean gum).
(4) Positive for xanthan gum when subjected to the following
procedure:
Pyruvic Acid Test
Pipet 10 milliliters of an 0.6 percent solution of the
polysaccharide in distilled water (60 milligrams of water-soluble gum)
into a 50-milliliter flask equipped with a standard taper glass joint.
Pipet in 20 milliliters of 1N hydrochloric acid. Weigh the flask. Reflux
the mixture for 3 hours. Take precautions to avoid loss of vapor during
the refluxing. Cool the solution to room temperature. Add distilled
water to make up any weight loss from the flask contents.
Pipet 1 milliliter of a 2,4-dinitrophenylhydrazine reagent (0.5
percent in 2N hydrochloric acid) into a 30-milliliter separatory funnel
followed by a 2-milliliter aliquot (4 milligrams of water-soluble gum)
of the polysaccharide hydrolyzate. Mix and allow the reaction mixture to
stand at room temperature for 5 minutes. Extract the mixture with 5
milliliters of ethyl acetate. Discard the aqueous layer.
Extract the hydrazone from the ethyl acetate with three 5 milliliter
portions of 10 percent sodium carbonate solution. Dilute the combined
sodium carbonate extracts to 100 milliliters with additional 10 percent
sodium carbonate in a 10-milliliter volumetric flask. Measure the
optical density of the sodium carbonate solution at 375 millimicrons.
Compare the results with a curve of the optical density versus
concentration of an authentic sample of pyruvic acid that has been run
through the procedure starting with the preparation of the hydrazone.
Record the percent by weight of pyruvic acid in the test
polysaccharide. Note "positive" for xanthan gum if the sample contains
more than 1.5 percent of pyruvic acid and "negative" for xanthan gum
if the sample
[[Page 71]]
contains less than 1.5 percent of pyruvic acid by weight.
(e) The additive is used or intended for use in accordance with good
manufacturing practice as a stabilizer, emulsifier, thickener,
suspending agent, bodying agent, or foam enhancer in foods for which
standards of identity established under section 401 of the Act do not
preclude such use.
(f) To assure safe use of the additive:
(1) The label of its container shall bear, in addition to other
information required by the Act, the name of the additive and the
designation "food grade".
(2) The label or labeling of the food additive container shall bear
adequate directions for use.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.710]
[Page 71]
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 H--Other Specific Usage Additives
Sec. 172.710 Adjuvants for pesticide use dilutions.
The following surfactants and related adjuvants may be safely added
to pesticide use dilutions by a grower or applicant prior to application
to the growing crop:
n-Alkyl (C8-C18) amine acetate, where the
alkyl groups (C8-C18) are derived from coconut
oil, as a surfactant in emulsifier blends at levels not in excess of 5
percent by weight of the emulsifier blends that are added to herbicides
for application to corn and sorghum.
Di-n-alkyl (C8-C18) dimethyl ammonium
chloride, where the alkyl groups (C8-C18) are
derived from coconut oil, as surfactants in emulsifier blends at levels
not in excess of 5 percent by weight of emulsifier blends that are added
to herbicides for application to corn or sorghum.
Diethanolamide condensate based on a mixture of saturated and
unsaturated soybean oil fatty acids (C16-C18) as a
surfactant in emulsifier blends that are added to the herbicide atrazine
for application to corn.
Diethanolamide condensate based on stripped coconut fatty acids
(C10 C18) as a surfactant in emulsifier blends
that are added to the herbicide atrazine for application to corn.
[alpha]-(p-Dodecylphenyl)-omega-hydroxypoly (oxyethylene) produced
by the condensation of 1 mole of dodecylphenol (dodecyl group is a
proplyene tetramer isomer) with an average of 4-14 or 30-70 moles of
ethylene oxide; if a blend of products is used, the average number of
moles of ethylene oxide reacted to produce any product that is a
component of the blend shall be in the range of 4-14 or 30-70.
Ethylene dichloride.
Polyglyceryl phthalate ester of coconut oil fatty acids.
[alpha]-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl) phenol with an average of 4-14 or 30-70 moles
of ethylene oxide; if a blend of products is used, the average number of
moles of ethylene oxide reacted to produce any product that is a
component of the blend shall be in the range of 4-14 or 30-70.
[alpha]-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl) phenol with 1 mole of ethylene oxide.
Sodium acrylate and acrylamide copolymer with a minimum average
molecular weight of 10,000,000 in which 30 percent of the polymer is
comprised of acrylate units and 70 percent acrylamide units, for use as
a drift control agent in herbicide formulations applied to crops at a
level not to exceed 0.5 ounces of the additive per acre.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.712]
[Page 71]
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 H--Other Specific Usage Additives
Sec. 172.712 1,3-Butylene glycol.
The food additive 1,3-butylene glycol (CAS Reg. No. 107-88-0) may be
safely used in food in accordance with the following prescribed
conditions:
(a) It is prepared by the aldol condensation of acetaldehyde
followed by catalytic hydrogenation.
(b) The food additive shall conform to the identity and
specifications listed in the monograph entitled "1,3-Butylene Glycol"
in the Food Chemicals Codex, 4th ed. (1996), p. 52, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the Office of Premarket Approval,
Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy.,
College Park, MD 20740, or 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 Office of the
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(c) It is used in the manufacture of sausage casings as a
formulation aid as defined in Sec. 170.3(o)(14) of this chapter and as a
processing aid as defined in Sec. 170.3(o)(24) of this chapter.
[62 FR 26228, May 13, 1997]
[[Page 72]]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.715]
[Page 72]
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 H--Other Specific Usage Additives
Sec. 172.715 Calcium lignosulfonate.
Calcium lignosulfonate may be safely used in or on food, subject to
the provisions of this section.
(a) Calcium lignosulfonate consists of sulfonated lignin, primarily
as calcium and sodium salts.
(b) It is used in an amount not to exceed that reasonably required
to accomplish the intended physical or technical effect when added as a
dispersing agent and stabilizer in pesticides for preharvest or
postharvest application to bananas.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.720]
[Page 72]
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 H--Other Specific Usage Additives
Sec. 172.720 Calcium lactobionate.
The food additive calcium lactobionate may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive is the calcium salt of lactobionic acid (4-
([beta],D-galactosido)-D-gluconic acid) produced by the oxidation of
lactose.
(b) It is used or intended for use as a firming agent in dry pudding
mixes at a level not greater than that required to accomplish the
intended effect.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.723]
[Page 72]
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 H--Other Specific Usage Additives
Sec. 172.723 Epoxidized soybean oil.
Epoxidized soybean oil may be safely used in accordance with the
following prescribed conditions:
(a) The additive is prepared by reacting soybean oil in toluene with
hydrogen peroxide and formic acid.
(b) It meets the following specifications:
(1) Epoxidized soybean oil contains oxirane oxygen, between 7.0 and
8.0 percent, as determined by the American Oil Chemists' Society
(A.O.C.S.) method Cd 9-57, "Oxirane Oxygen," reapproved 1989, which is
incorporated by reference in accordance with 5 U.S.C 552(a) and 1 CFR
part 51. Copies are available from the American Oil Chemists' Society,
P. O. Box 3489, Champaign, IL 61826-3489, or may be examined at the
Division of Petition Control (HFS-215), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 1110 Vermont Ave. NW.,
suite 1200, Washington, DC, or at the Office of the Federal Register,
800 North Capitol St. NW., suite 700, Washington, DC.
(2) The maximum iodine value is 3.0, as determined by A.O.C.S.
method Cd 1-25, "Iodine Value of Fats and Oils Wijs Method," revised
1993, which is incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. The availability of this incorporation by
reference is given in paragraph (b)(1) of this section.
(3) The heavy metals (as Pb) content cannot be more than 10 parts
per million, as determined by the "Heavy Metals Test," of the "Food
Chemicals Codex," 4th ed. (1996), pp. 760-761, Method II (with a 2-gram
sample and 20 microgram of lead ion in the control), which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the National Academy Press, Box 285,
2101 Constitution Ave. NW., Washington, DC 20055 (Internet address
"http://www.nap.edu"), or 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 Office of the
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(c) The additive is used as a halogen stabilizer in brominated
soybean oil at a level not to exceed 1 percent.
[60 FR 32903, June 26, 1995, as amended at 64 FR 1759, Jan. 12, 1999]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.725]
[Page 72-73]
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 H--Other Specific Usage Additives
Sec. 172.725 Gibberellic acid and its potassium salt.
The food additives gibberellic acid and its potassium salt may be
used in the malting of barley in accordance with the following
prescribed conditions:
(a) The additives meet the following specifications:
(1) The gibberellic acid is produced by deep-culture fermentation of
a suitable nutrient medium by a strain of Fusarium moniliforme or a
selection of this culture.
(2) The gibberellic acid produced is of 80 percent purity or better.
(3) The empirical formula of gibberellic acid is represented by
C19H22O6.
(4) Potassium gibberellate is the potassium salt of the specified
gibberellic acid.
(5) The potassium gibberellate is of 80 percent purity or better.
[[Page 73]]
(6) The gibberellic acid or potassium gibberellate may be diluted
with substances generally recognized as safe in foods or with salts of
fatty acids conforming to Sec. 172.863.
(b) They are used or intended for use in the malting of barley under
conditions whereby the amount of either or both additives present in the
malt is not in excess of 2 parts per million expressed as gibberellic
acid, and the treated malt is to be used in the production of fermented
malt beverages or distilled spirits only, whereby the finished distilled
spirits contain none and the finished malt beverage contains not more
than 0.5 part per million of gibberellic acid.
(c) To insure the safe use of the food additives the label of the
package shall bear, in addition to the other information required by the
Act:
(1) The name of the additive, "gibberellic acid" or "potassium
gibberellate", whichever is appropriate.
(2) An accurate statement of the concentration of the additive
contained in the package.
(3) Adequate use directions to provide not more than 2 parts per
million of gibberellic acid in the finished malt.
(4) Adequate labeling directions to provide that the final malt is
properly labeled as described in paragraph (d) of this section.
(d) To insure the safe use of the additive the label of the treated
malt shall bear, in addition to the other information required by the
Act, the statements:
(1) "Contains not more than 2 parts per million ------", the blank
being filled in with the words "gibberellic acid" or "potassium
gibberellate", whichever is appropriate; and
(2) "Brewer's malt--To be used in the production of fermented malt
beverages only" or "Distiller's malt--To be used in the production of
distilled spirits only", whichever is appropriate.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.730]
[Page 73]
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 H--Other Specific Usage Additives
Sec. 172.730 Potassium bromate.
The food additive potassium bromate may be safely used in the
malting of barley under the following prescribed conditions:
(a)(1) It is used or intended for use in the malting of barley under
conditions whereby the amount of the additive present in the malt from
the treatment does not exceed 75 parts per million of bromate
(calculated as Br), and the treated malt is used only in the production
of fermented malt beverages or distilled spirits.
(2) The total residue of inorganic bromides in fermented malt
beverages, resulting from the use of the treated malt plus additional
residues of inorganic bromides that may be present from uses in
accordance with other regulations in this chapter promulgated under
sections 408 and/or 409 of the act, does not exceed 25 parts per million
of bromide (calculated as Br). No tolerance is established for bromide
in distilled spirits because there is evidence that inorganic bromides
do not pass over in the distillation process.
(b) To assure safe use of the additive, the label or labeling of the
food additive shall bear, in addition to the other information required
by the Act, the following:
(1) The name of the additive.
(2) Adequate directions for use.
(c) To assure safe use of the additive, the label or labeling of the
treated malt shall bear, in addition to other information required by
the Act, the statement, "Brewer's Malt--To be used in the production of
fermented malt beverages only", or "Distiller's Malt--To be used in
the production of distilled spirits only", whichever is the case.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.735]
[Page 73]
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 H--Other Specific Usage Additives
Sec. 172.735 Glycerol ester of wood rosin.
Glycerol ester of wood rosin may be safely used in food in
accordance with the following prescribed conditions:
(a) It has an acid number of 3 to 9, a drop-softening point of 88
deg.C-96 deg.C; and a color of N or paler as determined in accordance
with Official Naval Stores Standards of the United States. It is
purified by countercurrent steam distillation.
(b) It is used to adjust the density of citrus oils used in the
preparation of beverages whereby the amount of the additive does not
exceed 100 parts per million of the finished beverage.
[[Page 74]]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.755]
[Page 74]
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 H--Other Specific Usage Additives
Sec. 172.755 Stearyl monoglyceridyl citrate.
The food additive stearyl monoglyceridyl citrate may be safely used
in food in accordance with the following provisions:
(a) The additive is prepared by controlled chemical reaction of the
following:
------------------------------------------------------------------------
Reactant Limitations
------------------------------------------------------------------------
Citric acid.............................. .............................
Monoglycerides of fatty acids............ Prepared by the glycerolysis
of edible fats and oils or
derived from fatty acids
conforming with Sec.
172.860.
Stearyl alcohol.......................... Derived from fatty acids
conforming with Sec.
172.860, or derived
synthetically in conformity
with Sec. 172.864.
------------------------------------------------------------------------
(b) The additive stearyl monoglyceridyl citrate, produced as
described under paragraph (a) of this section, meets the following
specifications:
Acid number 40 to 52.
Total citric acid 15 to 18 percent.
Saponification number 215-255.
(c) The additive is used or intended for use as an emulsion
stabilizer in or with shortenings containing emulsifiers.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.765]
[Page 74]
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 H--Other Specific Usage Additives
Sec. 172.765 Succistearin (stearoyl propylene glycol hydrogen succinate).
The food additive succistearin (stearoyl propylene glycol hydrogen
succinate) may be safely used in food in accordance with the following
prescribed conditions:
(a) The additive is the reaction product of succinic anhydride,
fully hydrogenated vegetable oil (predominantly C16 or
C18 fatty acid chain length), and propylene glycol.
(b) The additive meets the following specifications:
Acid number 50-150.
Hydroxyl number 15-50.
Succinated ester content 45-75 percent.
(c) The additive is used or intended for use as an emulsifier in or
with shortenings and edible oils intended for use in cakes, cake mixes,
fillings, icings, pastries, and toppings, in accordance with good
manufacturing practice.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.770]
[Page 74]
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 H--Other Specific Usage Additives
Sec. 172.770 Ethylene oxide polymer.
The polymer of ethylene oxide may be safely used as a foam
stabilizer in fermented malt beverages in accordance with the following
conditions.
(a) It is the polymer of ethylene oxide having a minimum viscosity
of 1,500 centipoises in a 1 percent aqueous solution at 25 deg.C.
(b) It is used at a level not to exceed 300 parts per million by
weight of the fermented malt beverage.
(c) The label of the additive bears directions for use to insure
compliance with paragraph (b) of this section.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.775]
[Page 74]
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 H--Other Specific Usage Additives
Sec. 172.775 Methacrylic acid-divinylbenzene copolymer.
Methacrylic acid-divinylbenzene copolymer may be safely used in food
in accordance with the following prescribed conditions:
(a) The additive is produced by the polymerization of methacrylic
acid and divinylbenzene. The divinylbenzene functions as a cross-linking
agent and constitutes a minimum of 4 percent of the polymer.
(b) Aqueous extractives from the additive do not exceed 2 percent
(dry basis) after 24 hours at 25 deg.C.
(c) The additive is used as a carrier of vitamin B12 in
foods for special dietary use.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.800]
[Page 74-75]
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. 172.800 Acesulfame potassium.
Acesulfame potassium (CAS Reg. No. 55589-62-3), also known as
acesulfame K, may be safely used as a sweetening agent in food in
accordance with the following prescribed conditions:
(a) Acesulfame potassium is the potassium salt of 6-methyl-1,2,3-
oxathiazine-4(3H)-one-2,2-dioxide.
(b) The additive meets the following specifications:
(1) Purity is not less than 99 percent on a dry basis. The purity
shall be determined by a method titled "Acesulfame Potassium Assay,"
which is incorporated by reference. Copies are available from the Center
for Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the Office of the Federal Register, 800
[[Page 75]]
North Capitol Street, NW., suite 700, Washington, DC 20408.
(2) Fluoride content is not more than 30 parts per million, as
determined by method III of the Fluoride Limit Test of the Food
Chemicals Codex, 3d Ed. (1981), p. 511, which is incorporated by
reference. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or available for inspection
at the Office of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC 20408.
(c) The additive may be used in the following foods when standards
of identity established under section 401 of the Federal Food, Drug, and
Cosmetic Act do not preclude such use:
(1) Sugar substitute, including granulated, powdered, liquid, and
tablet form.
(2) [Reserved]
(3) Chewing gum.
(4) Dry bases for beverages, instant coffee, and instant tea.
(5) Dry bases for gelatins, puddings, and pudding desserts.
(6) Dry bases for dairy product analogs.
(7) Confections, hard candy, and soft candy.
(8) Baked goods and baking mixes, including frostings, icings,
toppings, and fillings for baked goods.
(9) Yogurt and yogurt-type products.
(10) Frozen and refrigerated desserts.
(11) Sweet sauces, toppings, and syrups.
(12) Alcoholic beverages.
(13) Nonalcoholic beverages, including beverage bases.
(d) If the food containing the additive is represented to be for
special dietary uses, it shall be labeled in compliance with part 105 of
this chapter.
(e) The additive shall be used in accordance with current good
manufacturing practice in an amount not to exceed that reasonably
required to accomplish the intended effect.
[53 FR 28382, July 28, 1988, as amended at 57 FR 57961, Dec. 8, 1992; 59
FR 61540, 61543, 61545, Dec. 1, 1994; 60 FR 21702, May 3, 1995; 63 FR
36362, July 6, 1998]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.802]
[Page 75]
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. 172.802 Acetone peroxides.
The food additive acetone peroxides may be safely used in flour, and
in bread and rolls where standards of identity do not preclude its use,
in accordance with the following prescribed conditions:
(a) The additive is a mixture of monomeric and linear dimeric
acetone peroxide, with minor proportions of higher polymers,
manufactured by reaction of hydrogen peroxide and acetone.
(b) The additive may be mixed with an edible carrier to give a
concentration of: (1) 3 grams to 10 grams of hydrogen peroxide
equivalent per 100 grams of the additive, plus carrier, for use in flour
maturing and bleaching; or (2) approximately 0.75 gram of hydrogen
peroxide equivalent per 100 grams of the additive, plus carrier, for use
in dough conditioning.
(c) It is used or intended for use: (1) In maturing and bleaching of
flour in a quantity not more than sufficient for such effect; and (2) as
a dough-conditioning agent in bread and roll production at not to exceed
the quantity of hydrogen peroxide equivalent necessary for the
artificial maturing effect.
(d) To insure safe use of the additive, the label of the food
additive container and any intermediate premix thereof shall bear, in
addition to the other information required by the act:
(1) The name of the additive, "acetone peroxides".
(2) The concentration of the additive expressed in hydrogen peroxide
equivalents per 100 grams.
(3) Adequate use directions to provide a final product that complies
with the limitations prescribed in paragraph (c) of this section.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.804]
[Page 75-76]
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. 172.804 Aspartame.
The food additive aspartame may be safely used in food in accordance
with good manufacturing practice as a sweetening agent and a flavor
enhancer in foods for which standards of identity established under
section 401 of the act do not preclude such use under the following
conditions:
(a) Aspartame is the chemical 1-methyl N-l-[alpha]-aspartyl-l-
phenylalanine (C14H18N2O5).
(b) The additive meets the specifications of the "Food Chemicals
Codex,"
[[Page 76]]
3d Ed. (1981) pp. 28-29 and First Supplement p. 5, which is incorporated
by reference in accordance with 5 U.S.C. 552(a). Copies are available
from the National Academy Press, 2101 Constitution Ave. NW., Washington,
DC 20418, or 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 Office of the Federal Register,
800 North Capitol St. NW., suite 700, Washington, DC.
(c)(1) When aspartame is used as a sugar substitute tablet for
sweetening hot beverages, including coffee and tea, L-leucine may be
used as a lubricant in the manufacture of such tablets at a level not to
exceed 3.5 percent of the weight of the tablet.
(2) When aspartame is used in baked goods and baking mixes, the
amount of the additive is not to exceed 0.5 percent by weight of ready-
to-bake products or of finished formulations prior to baking. Generally
recognized as safe (GRAS) ingredients or food additives approved for use
in baked goods shall be used in combination with aspartame to ensure its
functionality as a sweetener in the final baked product. The level of
aspartame used in these products is determined by an analytical method
entitled "Analytical Method for the Determination of Aspartame and
Diketopiperazine in Baked Goods and Baking Mixes," October 8, 1992,
which was developed by the Nutrasweet Co. Copies are available from the
Office of Premarket Approval (HFS-200), Center for Food Safety and
Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, or
are available for inspection at the Center for Food Safety and Applied
Nutrition's Library, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740 20204, and the Office of the Federal
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(d) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The principal display panel of any intermediate mix of the
additive for manufacturing purposes shall bear a statement of the
concentration of the additive contained therein;
(2) The label of any food containing the additive shall bear, either
on the principal display panel or on the information panel, the
following statement:
PHENYLKETONURICS: CONTAINS PHENYLALANINE
The statement shall appear in the labeling prominently and conspicuously
as compared to other words, statements, designs or devices and in bold
type and on clear contrasting background in order to render it likely to
be read and understood by the ordinary individual under customary
conditions of purchase and use.
(3) When the additive is used in a sugar substitute for table use,
its label shall bear instructions not to use in cooking or baking.
(4) Packages of the dry, free-flowing additive shall prominently
display the sweetening equivalence in teaspoons of sugar.
(e) If the food containing the additive purports to be or is
represented for special dietary uses, it shall be labeled in compliance
with part 105 of this chapter.
[39 FR 27319, July 26, 1974]
Editorial Note: For Federal Register citations affecting
Sec. 172.804, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.806]
[Page 76-77]
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. 172.806 Azodicarbonamide.
The food additive azodicarbonamide may be safely used in food in
accordance with the following prescribed conditions:
(a) It is used or intended for use:
(1) As an aging and bleaching ingredient in cereal flour in an
amount not to exceed 2.05 grams per 100 pounds of flour (0.0045 percent;
45 parts per million).
(2) As a dough conditioner in bread baking in a total amount not to
exceed 0.0045 percent (45 parts per million) by weight of the flour
used, including any quantity of azodicarbonamide added to flour in
accordance with paragraph (a)(1) of this section.
(b) To assure safe use of the additive:
(1) The label and labeling of the additive and any intermediate
premix prepared therefrom shall bear, in addition to the other
information required by the Act, the following:
[[Page 77]]
(i) The name of the additive.
(ii) A statement of the concentration or the strength of the
additive in any intermediate premixes.
(2) The label or labeling of the food additive shall also bear
adequate directions for use.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.808]
[Page 77]
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. 172.808 Copolymer condensates of ethylene oxide and propylene oxide.
Copolymer condensates of ethylene oxide and propylene oxide may be
safely used in food under the following prescribed conditions:
(a) The additive consists of one of the following:
(1) [alpha]-Hydro-omega-hydroxy-poly (oxyethylene)
poly(oxypropylene)-(55-61 moles)poly(oxyethylene) block copolymer,
having a molecular weight range of 9,760-13,200 and a cloud point above
100 deg.C in 1 percent aqueous solution.
(2) [alpha]-Hydro-omega-hydroxy-poly
(oxyethylene)poly(oxypropylene)-(53-59 moles)poly(oxyethylene)(14-16
moles) block copolymer, having a molecular weight range of 3,500-4,125
and a cloud point of 9 deg.C-12 deg.C in 10 percent aqueous solution.
(3) [alpha]-Hydro-omega-hydroxy-poly(ox-yethylene)/
poly(oxypropylene) (minimum 15 moles)/poly(oxyethylene) block copolymer,
having a minimum average molecular weight of 1900 and a minimum cloud
point of 9 deg.C-12 deg.C in 10 percent aqueous solution.
(4) [alpha]-Hydro-omega-hydroxy-poly(ox-yethylene) poly
(oxypropylene)-(51-57 moles) poly(oxyethylene) block copolymer, having
an average molecular weight of 14,000 and a cloud point above 100 deg.C
in 1 percent aqueous solution.
(b) The additive is used or intended for use as follows:
(1) The additive identified in paragraph (a)(1) of this section is
used in practice as a solubilizing and stabilizing agent in flavor
concentrates (containing authorized flavoring oils) for use in foods for
which standards of identity established under section 401 of the Act do
not preclude such use, provided that the weight of the additive does not
exceed the weight of the flavoring oils in the flavor concentrate.
(2) The additive identified in paragraph (a)(2) of this section is
used as a processing aid and wetting agent in combination with dioctyl
sodium sulfosuccinate for fumaric acid as prescribed in Sec. 172.810.
(3) The additive identified in paragraph (a)(3) of this section is
used:
(i) As a surfactant and defoaming agent, at levels not to exceed
0.05 percent by weight, in scald baths for poultry defeathering,
followed by potable water rinse. The temperatures of the scald baths
shall be not less than 125 deg.F.
(ii) As a foam control and rinse adjuvant in hog dehairing machines
at a use level of not more than 5 grams per hog.
(4) The additive identified in paragraph (a)(4) of this section is
used as a dough conditioner in yeast-leavened bakery products for which
standards of identity established under section 401 of the Act do not
preclude such use, provided that the amount of the additive dose not
exceed 0.5 percent by weight of the flour used.
[42 FR 14491, Mar. 15, 1977, as amended at 46 FR 57476, Nov. 24, 1981]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.809]
[Page 77-78]
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. 172.809 Curdlan.
Curdlan may be safely used in accordance with the following
conditions:
(a) Curdlan is a high molecular weight polymer of glucose ([beta]-
1,3-glucan; CAS Reg. No. 54724-00-4) produced by pure culture
fermentation from the nonpathogenic and nontoxicogenic bacterium
Alcaligenes faecalis var. myxogenes.
(b) Curdlan meets the following specifications when it is tested
according to the methods described or referenced in the document
entitled "Analytical Methods for Specification Tests for Curdlan," by
Takeda Chemical Industries, Ltd., 12-10 Nihonbashi, 2-Chome, Chuo-ku,
Tokyo, 103, Japan, 1996, which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available
from the Division of Petition Control (HFS-215), Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or 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 Office of the
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
[[Page 78]]
(1) Positive for curdlan.
(2) Assay for curdlan (calculated as anhydrous glucose), not less
than 80 percent.
(3) pH of 1 percent aqueous suspension, 6.0-7.5.
(4) Lead, not more than 0.5 mg/kg.
(5) Heavy metals (as Pb), not more than 0.002 percent.
(6) Total nitrogen, not more than 0.2 percent.
(7) Loss on drying, not more than 10 percent.
(8) Residue on ignition, not more than 6 percent.
(9) Gel strength of 2 percent aqueous suspension, not less than
600x10\3\ dyne per square centimeter.
(10) Aerobic plate count, not more than 10\3\ per gram.
(11) Coliform bacteria, not more than 3 per gram.
(c) Curdlan is used or intended for use in accordance with good
manufacturing practice as a formulation aid, processing aid, stabilizer
and thickener, and texturizer in foods for which standards of identity
established under section 401 of the act do not preclude such use.
[61 FR 65941, Dec. 16, 1996]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.810]
[Page 78]
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. 172.810 Dioctyl sodium sulfosuccinate.
The food additive dioctyl sodium sulfosuccinate, which meets the
specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 102-104,
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 Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408), may be
safely used in food in accordance with the following prescribed
conditions:
(a) As a wetting agent in the following fumaric acid-acidulated
foods: Dry gelatin dessert, dry beverage base, and fruit juice drinks,
when standards of identity do not preclude such use. The labeling of the
dry gelatin dessert and dry beverage base shall bear adequate directions
for use, and the additive shall be used in such an amount that the
finished gelatin dessert will contain not in excess of 15 parts per
million of the additive and the finished beverage or fruit juice drink
will contain not in excess of 10 parts per million of the additive.
(b) As a processing aid in sugar factories in the production of
unrefined cane sugar, in an amount not in excess of 0.5 part per million
of the additive per percentage point of sucrose in the juice, syrup, or
massecuite being processed, and so used that the final molasses will
contain no more than 25 parts per million of the additive.
(c) As a solubilizing agent on gums and hydrophilic colloids to be
used in food as stabilizing and thickening agents, when standards of
identity do not preclude such use. The additive is used in an amount not
to exceed 0.5 percent by weight of the gums or hydrophilic colloids.
(d) As an emulsifying agent for cocoa fat in noncarbonated beverages
containing cocoa, whereby the amount of the additive does not exceed 25
parts per million of the finished beverage.
(e) As a dispersing agent in "cocoa with dioctyl sodium
sulfosuccinate for manufacturing" that conforms to the provisions of
Sec. 163.117 of this chapter and the use limitations prescribed in
Sec. 172.520, in an amount not to exceed 0.4 percent by weight thereof.
(f) As a processing aid and wetting agent in combination with
[alpha]-hydro-omega -hydroxy - poly(oxyethylene) - poly-(oxypropylene)
(53-59 moles) poly(oxyethylene) (14-16 moles) block copolymer, having a
molecular weight range of 3,500-4,125 and a cloud point of 9 deg.C-12
deg.C in 10 percent aqueous solution, for fumaric acid used in fumaric
acid-acidulated dry beverage base and in fumaric acid-acidulated fruit
juice drinks, when standards of identity do not preclude such use. The
labeling of the dry beverage base shall bear adequate directions for
use, and the additives shall be used in such an amount that the finished
beverage or fruit juice drink will contain not in excess of a total of
10 parts per million of the dioctyl sodium sulfosuccinate-block
copolymer combination.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]
[[Page 79]]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.811]
[Page 79]
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. 172.811 Glyceryl tristearate.
The food additive glyceryl tristearate may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive (CAS Reg. No. 555-43-1) is prepared by
reacting stearic acid with glycerol in the presence of a suitable
catalyst.
(b) The food additive meets the following specifications:
Acid number: Not to exceed 1.0.
Iodine number: Not to exceed 1.0.
Saponification number: 186-192.
Hydroxyl number: Not to exceed 5.0.
Free glycerol content: Not to exceed 0.5 percent.
Unsaponifiable matter: Not to exceed 0.5 percent.
Melting point (Class II): 69 deg.C-73 deg.C.
(c) The additive is used or intended for use as follows when
standards of identity established under section 401 of the Act do not
preclude such use:
------------------------------------------------------------------------
Uses Limitations
------------------------------------------------------------------------
1. As a crystallization accelerator Not to exceed 1 percent of the
in cocoa products, in imitation combined weight of the
chocolate, and in compound coatings. formulation.
2. As a formulation aid as defined in Not to exceed 0.5 percent.
Sec. 170.3(o)(14) of this chapter,
lubricant and release agent as
defined in Sec. 170.3(o)(18) of
this chapter, and surface-finishing
agent as defined in Sec.
170.3(o)(30) of this chapter in food.
3. As a formulation aid as defined in Not to exceed 3.0 percent of the
Sec. 170.3(o)(14) of this chapter combined weight of the
in confections. formulation.
4. As a formulation aid as defined in Not to exceed 1.0 percent of the
Sec. 170.3(o)(14) of this chapter combined weight of the
in fats and oils as defined in Sec. formulation.
170.3 (n)(12) of this chapter.
5. As a winterization and Not to exceed 0.5 percent by
fractionation aid in fat and oil weight of the processed fat or
processing. oil.
------------------------------------------------------------------------
(d) To assure safe use of the additive:
(1) In addition to the other information required by the act, the
label or labeling of the additive shall bear the name of the additive.
(2) The label of the additive shall bear adequate directions to
provide a final product that complies with the limitations prescribed in
paragraph (c) of this section.
[53 FR 21632, June 9, 1988, as amended at 59 FR 24924, May 13, 1994]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.812]
[Page 79]
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. 172.812 Glycine.
The food additive glycine may be safely used for technological
purposes in food in accordance with the following prescribed conditions:
(a) The additive complies with the specifications of the "Food
Chemicals Codex," 3d Ed. (1981), p. 140, 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
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(b) The additive is used or intended for use as follows:
------------------------------------------------------------------------
Uses Limitations
------------------------------------------------------------------------
As a masking agent for the bitter Not to exceed 0.2 percent in
aftertaste of saccharin used in the finished beverage.
manufactured beverages and beverage bases.
As a stabilizer in mono- and diglycerides Not to exceed 0.02 percent
prepared by the glycerolysis of edible of the mono- and
fats or oils. diglycerides.
------------------------------------------------------------------------
(c) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The labeling of the additive shall bear adequate directions for
use of the additive in compliance with the provisions of this section.
(2) The labeling of beverage bases containing the additive shall
bear adequate directions for use to provide that beverages prepared
therefrom shall contain no more than 0.2 percent glycine.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.814]
[Page 79-80]
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. 172.814 Hydroxylated lecithin.
The food additive hydroxylated lecithin may be safely used as an
emulsifier in foods in accordance with the following conditions:
(a) The additive is obtained by the treatment of lecithin in one of
the following ways, under controlled conditions whereby the separated
fatty acid fraction of the resultant product has an acetyl value of 30
to 38:
(1) With hydrogen peroxide, benzoyl peroxide, lactic acid, and
sodium hydroxide.
[[Page 80]]
(2) With hydrogen peroxide, acetic acid, and sodium hydroxide.
(b) It is used or intended for use, in accordance with good
manufacturing practice, as an emulsifier in foods, except for those
standardized foods that do not provide for such use.
(c) To assure safe use of the additive, the label of the food
additive container shall bear, in addition to the other information
required by the Act:
(1) The name of the additive, "hydroxylated lecithin".
(2) Adequate directions for its use.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.816]
[Page 80]
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. 172.816 Methyl glucoside-coconut oil ester.
Methyl glucoside-coconut oil ester may be safely used in food in
accordance with the following conditions:
(a) It is the methyl glucoside-coconut oil ester having the
following specifications:
Acid number: 10-20
Hydroxyl number: 200-300
pH (5% aqueous): 4.8-5.0
Saponification number: 178-190
(b) It is used or intended for use as follows:
(1) As an aid in crystallization of sucrose and dextrose at a level
not to exceed the minimum quantity required to produce its intended
effect.
(2) As a surfactant in molasses at a level not to exceed 320 parts
per million in the molasses.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.818]
[Page 80]
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. 172.818 Oxystearin.
The food additive oxystearin may be safely used in foods, when such
use is not precluded by standards of identity in accordance with the
following conditions:
(a) The additive is a mixture of the glycerides of partially
oxidized stearic and other fatty acids obtained by heating hydrogenated
cottonseed or soybean oil under controlled conditions, in the presence
of air and a suitable catalyst which is not a food additive as so
defined. The resultant product meets the following specifications:
Acid number: Maximum 15.
Iodine number: Maximum 15.
Saponification number: 225-240.
Hydroxyl number: 30-45.
Unsaponifiable material: Maximum 0.8 percent.
Refractive index (butyro): 601 at 48 deg.C.
(b) It is used or intended for use as a crystallization inhibitor in
vegetable oils and as a release agent in vegetable oils and vegetable
shortenings, whereby the additive does not exceed 0.125 percent of the
combined weight of the oil or shortening.
(c) To insure safe use of the additive, the label and labeling of
the additive container shall bear, in addition to the other information
required by the Act:
(1) The name of the additive.
(2) Adequate directions to provide an oil or shortening that
complies with the limitations prescribed in paragraph (b) of this
section.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.820]
[Page 80-81]
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. 172.820 Polyethylene glycol (mean molecular weight 200-9,500).
Polyethylene glycol identified in this section may be safely used in
food in accordance with the following prescribed conditions:
(a) Identity. (1) The additive is an addition polymer of ethylene
oxide and water with a mean molecular weight of 200 to 9,500.
(2) It contains no more than 0.2 percent total by weight of ethylene
and diethylene glycols when tested by the analytical methods prescribed
in paragraph (b) of this section.
(b) Analytical method. (1) The analytical method prescribed in the
National Formulary XV (1980), page 1244, for polyethylene glycol 400
shall be used to determine the total ethylene and diethylene glycol
content of polyethylene glycols having mean molecular weights of 450 or
higher.
(2) The following analytical method shall be used to determine the
total ethylene and diethylene glycol content of polyethylene glycols
having mean molecular weights below 450.
Analytical Method
ethylene glycol and diethylene glycol content of polyethylene glycols
The analytical method for determining ethylene glycol and diethylene
glycol is as follows:
apparatus
Gas chromatograph with hydrogen flame ionization detector (Varian
Aerograph 600 D or equivalent). The following conditions shall be
employed with the Varian Aerograph 600 D gas chromatograph:
[[Page 81]]
Column temperature: 165 deg.C.
Inlet temperature: 260 deg.C.
Carrier gas (nitrogen) flow rate: 70 milliliters per minute.
Hydrogen and air flow to burner: Optimize to give maximum
sensitivity.
Sample size: 2 microliters.
Elution time: Ethylene glycol: 2.0 minutes. Diethylene glycol: 6.5
minutes.
Recorder: -0.5 to +1.05 millivolt, full span, 1 second full response
time.
Syringe: 10-microliter (Hamilton 710 N or equivalent).
Chromatograph column: 5 feet x \1/8\ inch. I.D. stainless steel tube
packed with sorbitol (Mathieson-Coleman-Bell 2768 Sorbitol SX850, or
equivalent) 12 percent in H2O by weight on 60-80 mesh nonacid
washed diatomaceous earth (Chromosorb W. Johns-Manville, or equivalent).
reagents and materials
Carrier gas, nitrogen: Commercial grade in cylinder equipped with
reducing regulator to provide 50 p.s.i.g. to the gas chromatograph.
Ethylene glycol: Commercial grade. Purify if necessary, by
distillation.
Diethylene glycol: Commercial grade. Purify, if necessary, by
distillation.
Glycol standards: Prepare chromatographic standards by dissolving
known amounts of ethylene glycol and diethylene glycol in water.
Suitable concentrations for standardization range from 1 to 6 milligrams
of each component per milliliter (for example 10 milligrams diluted to
volume in a 10-milliliter volumetric flask is equivalent to 1 milligram
per milliliter).
standardization
Inject a 2-microliter aliquot of the glycol standard into the gas
chromatograph employing the conditions described above. Measure the net
peak heights for the ethylene glycol and for the diethylene glycol.
Record the values as follows:
A=Peak height in millimeters of the ethylene glycol peak.
B=milligrams of ethylene glycol per milliliter of standard solution.
C=Peak height in millimeters of the diethylene glycol peak.
D=Milligrams of diethylene glycol per milliliter of standard
solution.
procedure
Weigh approximately 4 grams of polyethylene glycol sample accurately
into a 10-milliliter volumetric flask. Dilute to volume with water. Mix
the solution thoroughly and inject a 2-microliter aliquot into the gas
chromatograph. Measure the heights, in millimeters, of the ethylene
glycol peak and of the diethylene glycol peak and record as E and F,
respectively.
Percent ethylene glycol=(ExB)/(Axsample weight in grams)
Percent diethylene glycol=(FxD)/(Cxsample weight in grams)
(c) Uses. It may be used, except in milk or preparations intended
for addition to milk, as follows:
(1) As a coating, binder, plasticizing agent, and/or lubricant in
tablets used for food.
(2) As an adjuvant to improve flavor and as a bodying agent in
nonnutritive sweeteners identified in Sec. 180.37 of this chapter.
(3) As an adjuvant in dispersing vitamin and/or mineral
preparations.
(4) As a coating on sodium nitrite to inhibit hygroscopic
properties.
(d) Limitations. (1) It is used in an amount not greater than that
required to produce the intended physical or technical effect.
(2) A tolerance of zero is established for residues of polyethylene
glycol in milk.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.822]
[Page 81-82]
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. 172.822 Sodium lauryl sulfate.
The food additive sodium lauryl sulfate may be safely used in food
in accordance with the following conditions:
(a) The additive meets the following specifications:
(1) It is a mixture of sodium alkyl sulfates consisting chiefly of
sodium lauryl sulfate
[CH2(CH2)10CH2OSO2
Na].
(2) It has a minimum content of 90 percent sodium alkyl sulfates.
(b) It is used or intended for use:
(1) As an emulsifier in or with egg whites whereby the additive does
not exceed the following limits:
Egg white solids, 1,000 parts per million.
Frozen egg whites, 125 parts per million.
Liquid egg whites, 125 parts per million.
(2) As a whipping agent at a level not to exceed 0.5 percent by
weight of gelatine used in the preparation of marshmallows.
(3) As a surfactant in:
(i) Fumaric acid-acidulated dry beverage base whereby the additive
does not exceed 25 parts per million of the finished beverage and such
beverage base is not for use in a food for which a standard of identity
established
[[Page 82]]
under section 401 of the Act precludes such use.
(ii) Fumaric acid-acidulated fruit juice drinks whereby the additive
does not exceed 25 parts per million of the finished fruit juice drink
and it is not used in a fruit juice drink for which a standard of
identity established under section 401 of the Act precludes such use.
(4) As a wetting agent at a level not to exceed 10 parts per million
in the partition of high and low melting fractions of crude vegetable
oils and animal fats, provided that the partition step is followed by a
conventional refining process that includes alkali neutralization and
deodorization of the fats and oils.
(c) To insure the safe use of the additive, the label of the food
additive container shall bear, in addition to the other information
required by the Act:
(1) The name of the additive, sodium lauryl sulfate.
(2) Adequate use directions to provide a final product that complies
with the limitations prescribed in paragraph (b) of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 18668, May 2, 1978]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.824]
[Page 82]
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. 172.824 Sodium mono- and dimethyl naphthalene sulfonates.
The food additive sodium mono- and dimethyl naphthalene sulfonates
may be safely used in accordance with the following prescribed
conditions:
(a) The additive has a molecular weight range of 245-260.
(b) The additive is used or intended for use:
(1) In the crystallization of sodium carbonate in an amount not to
exceed 250 parts per million of the sodium carbonate. Such sodium
carbonate is used or intended for use in potable water systems to reduce
hardness and aid in sedimentation and coagulation by raising the pH for
the efficient utilization of other coagulation materials.
(2) As an anticaking agent in sodium nitrite at a level not in
excess of 0.1 percent by weight thereof for authorized uses in cured
fish and meat.
(c) In addition to the general labeling requirements of the Act:
(1) Sodium carbonate produced in accordance with paragraph (b)(1) of
this section shall be labeled to show the presence of the additive and
its label or labeling shall bear adequate directions for use.
(2) Sodium nitrite produced in accordance with paragraph (b)(2) of
this section shall bear the labeling required by Sec. 172.175 and a
statement declaring the presence of sodium mono- and dimethyl
naphthalene sulfonates.
[42 FR 14491, Mar. 15, 1977, as amended at 63 FR 7069, Feb. 12, 1998]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.826]
[Page 82]
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. 172.826 Sodium stearyl fumarate.
Sodium stearyl fumarate may be safely used in food in accordance
with the following conditions:
(a) It contains not less than 99 percent sodium stearyl fumarate
calculated on the anhydrous basis, and not more than 0.25 percent sodium
stearyl maleate.
(b) The additive is used or intended for use:
(1) As a dough conditioner in yeast-leavened bakery products in an
amount not to exceed 0.5 percent by weight of the flour used.
(2) As a conditioning agent in dehydrated potatoes in an amount not
to exceed 1 percent by weight thereof.
(3) As a stabilizing agent in nonyeast-leavened bakery products in
an amount not to exceed 1 percent by weight of the flour used.
(4) As a conditioning agent in processed cereals for cooking in an
amount not to exceed 1 percent by weight of the dry cereal, except for
foods for which standards of identity preclude such use.
(5) As a conditioning agent in starch-thickened or flour-thickened
foods in an amount not to exceed 0.2 percent by weight of the food.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.828]
[Page 82-83]
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. 172.828 Acetylated monoglycerides.
The food additive acetylated monoglycerides may be safely used in or
on food in accordance with the following prescribed conditions:
(a) The additive is manufactured by:
(1) The interesterification of edible fats with triacetin and in the
presence of catalytic agents that are not food additives or are
authorized by regulation, followed by a molecular distillation or by
steam stripping; or
[[Page 83]]
(2) The direct acetylation of edible monoglycerides with acetic
anhydride without the use of catalyst or molecular distillation, and
with the removal by vacuum distillation, if necessary, of the acetic
acid, acetic anhydride, and triacetin.
(b) The food additive has a Reichert-Meissl value of 75-200 and an
acid value of less than 6.
(c) The food additive is used at a level not in excess of the amount
reasonably required to produce its intended effect in food, or in food-
processing, food-packing, or food-storage equipment.
[42 FR 14491, Mar. 15, 1977, as amended at 50 FR 3508, Jan. 25, 1985]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.829]
[Page 83]
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. 172.829 Neotame.
(a) Neotame is the chemical N-[N-(3,3-dimethylbutyl)-L-[agr]-
aspartyl]-L-phenylalanine-1-methyl ester (CAS Reg. No. 165450-17-9).
(b) Neotame meets the following specifications when it is tested
according to the methods described or referenced in the document
entitled "Specifications and Analytical Methods for Neotame" dated
April 3, 2001, by the NutraSweet Co., 699 North Wheeling Rd., Mount
Prospect, IL 60056. The Director of the Office of the Federal Register
has approved the incorporation by reference of this material in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available
from the Office of Food Additive Safety (HFS-200), Center for Food
Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD
20740. Copies may be examined at the Center for Food Safety and Applied
Nutrition's Library, 5100 Paint Branch Pkwy., rm. 1C-100, College Park,
MD 20740, or at the Office of the Federal Register, 800 North Capitol
St. NW., suite 700, Washington, DC 20001.
(1) Assay for neotame, not less than 97.0 percent and not more than
102.0 percent on a dry basis.
(2) Free dipeptide acid (N-[N-(3,3-dimethylbutyl)-L-[agr]-aspartyl]-
L-phenylalanine), not more than 1.5 percent.
(3) Other related substances, not more than 2.0 percent.
(4) Lead, not more than 2.0 milligrams per kilogram.
(5) Water, not more than 5.0 percent.
(6) Residue on ignition, not more than 0.2 percent
(7) Specific rotation, determined at 20 deg.C [[agr]]D:
-40.0 deg. to 43.4 deg. calculated on a dry basis.
(c) The food additive neotame may be safely used as a sweetening
agent and flavor enhancer in foods generally, except in meat and
poultry, in accordance with current good manufacturing practice, in an
amount not to exceed that reasonably required to accomplish the intended
technical effect, in foods for which standards of identity established
under section 401 of the Federal Food, Drug, and Cosmetic Act do not
preclude such use.
(d) When neotame is used as a sugar substitute tablet, L-leucine may
be used as a lubricant in the manufacture of tablets at a level not to
exceed 3.5 percent of the weight of the tablet.
(e) If the food containing the additive purports to be or is
represented to be for special dietary use, it shall be labeled in
compliance with part 105 of this chapter.
[67 FR 45310, July 9, 2002]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.830]
[Page 83-84]
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. 172.830 Succinylated monoglycerides.
The food additive succinylated monoglycerides may be safely used in
food in accordance with the following prescribed conditions:
(a) The additive is a mixture of semi-and neutral succinic acid
esters of mono- and diglycerides produced by the succinylation of a
product obtained by the glycerolysis of edible fats and oils, or by the
direct esterification of glycerol with edible fat-forming fatty acids.
(b) The additive meets the following specifications:
Succinic acid content: 14.8%-25.6%
Melting point: 50 deg.C-60 deg.C.
Acid number: 70-120
(c) The additive is used or intended for use in the following foods:
(1) As an emulsifier in liquid and plastic shortenings at a level
not to exceed 3 percent by weight of the shortening.
(2) As a dough conditioner in bread baking, when such use is
permitted by an appropriate food standard, at a level
[[Page 84]]
not to exceed 0.5 percent by weight of the flour used.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.831]
[Page 84]
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. 172.831 Sucralose.
(a) Sucralose is the chemical 1,6-dichloro-1,6-dideoxy-[beta]-D-
fructofuranosyl-4-chloro-4-deoxy-[alpha]-D-galactopyranoside (CAS Reg.
No. 56038-13-2).
(b) The additive meets the specifications of the "Food Chemicals
Codex," 4th ed. (1996), pp. 398-400, which is incorporated by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are
available from the the Division of Product Policy (HFS-206), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, or may be examined at the
Center for Food Safety and Applied Nutrition's Library, 5100 Paint
Branch Pkwy., College Park, MD 20740 20204-0001, or the Office of the
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(c) The additive may be used as a sweetener in foods generally, in
accordance with current good manufacturing practice in an amount not to
exceed that reasonably required to accomplish the intended effect.
(d) If the food containing the additive purports to be or is
represented to be for special dietary use, it shall be labeled in
compliance with part 105 of this chapter.
[63 FR 16433, Apr. 3, 1998, as amended at 64 FR 43909, Aug. 12, 1999]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.832]
[Page 84]
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. 172.832 Monoglyceride citrate.
A food additive that is a mixture of glyceryl monooleate and its
citric acid monoester manufactured by the reaction of glyceryl
monooleate with citric acid under controlled conditions may be safely
used as a synergist and solubilizer for antioxidants in oils and fats,
when used in accordance with the conditions prescribed in this section.
(a) The food additive meets the following specifications:
Acid number, 70-100.
Total citric acid (free and combined), 14 percent-17 percent.
(b) It is used, or intended for use, in antioxidant formulations for
addition to oils and fats whereby the additive does not exceed 200 parts
per million of the combined weight of the oil or fat and the additive.
(c) To assure safe use of the additive:
(1) The container label shall bear, in addition to the other
information required by the Act, the name of the additive.
(2) The label or accompanying labeling shall bear adequate
directions for the use of the additive which, if followed, will result
in a food that complies with the requirements of this section.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.833]
[Page 84-85]
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. 172.833 Sucrose acetate isobutyrate (SAIB).
Sucrose acetate isobutyrate may be safely used in foods in
accordance with the following prescribed conditions:
(a) Sucrose acetate isobutyrate (CAS Reg. No. 27216-37-1), or SAIB,
is the chemical alpha-D-glucopyranoside, O-acetyl-tris-O-(2-methyl-1-
oxopropyl)-beta-D-fructofuranosyl, acetate tris(2-methyl propanoate).
(b) SAIB, a pale, straw-colored liquid, meets the following
specifications: (1) Assay: Not less than 98.8 percent and not more than
101.9 percent, based on the following formula:
Assay = ((SV 0.10586) / 56.1) x 100
Where SV = Saponification value
(2) Saponification value: 524-540 determined using 1 gram of sample
by the "Guide to Specifications for General Notices, General Analytical
Techniques, Identification Tests, Test Solutions, and Other Reference
Materials," in the "Compendium of Food Additive Specifications,
Addendum 4, Food and Agriculture Organization of the United Nations
(FAO), Food and Nutrition Paper 5, Revision 2" (1991), pp. 203 and 204,
which is incorporated by reference, in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. Copies are available from the Office of Premarket
Approval, Center for Food Safety and Applied Nutrition (HFS-200), Food
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, or may be examined at the Center for Food Safety and Applied
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or
at the Office of the Federal Register, 800 North Capitol St. NW., suite
700, Washington, DC.
[[Page 85]]
(3) Acid value: Not to exceed 0.20 determined using 50 grams of
sample by the "Guide to Specifications for General Notices, General
Analytical Techniques, Identification Tests, Test Solutions, and Other
Reference Materials," in the "Compendium of Food Additive
Specifications, Addendum 4, FAO Food and Nutrition Paper 5, Revision
2," p. 189 (1991), which is incorporated by reference; see paragraph
(b)(2) of this section for availability of the incorporation by
reference.
(4) Lead: Not to exceed 1.0 milligrams/kilogram determined by the
"Atomic Absorption Spectrophotometric Graphite Furnace Method, Method
I," in the "Food Chemicals Codex," 4th ed. (1996), pp. 763 and 764,
with an attached modification to the sample digestion section in
Appendix III.B (July 1996), which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Box 285, Washington, DC 20055 (Internet "http://www.nap.edu"), or
may be examined at the Center for Food Safety and Applied Nutrition's
Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the
Office of the Federal Register, 800 North Capitol St. NW., suite 700,
Washington, DC.
(5) Triacetin: Not to exceed 0.10 percent determined by gas
chromatography as described in the "Guide to Specifications for General
Notices, General Analytical Techniques, Identification Tests, Test
Solutions, and Other Reference Materials," in the "Compendium of Food
Additive Specifications, Addendum 4, FAO Food and Nutrition Paper 5,
Revision 2," (1991), pp. 13-26, which is incorporated by reference; see
paragraph (b)(2) of this section for availability of the incorporation
by reference.
(c) The food additive is used as a stabilizer (as defined in
Sec. 170.3(o)(28) of this chapter) of emulsions of flavoring oils in
nonalcoholic beverages.
(d) The total SAIB content of a beverage containing the additive
does not exceed 300 milligrams/kilogram of the finished beverage.
[64 FR 29958, June 4, 1999; 64 FR 43072, Aug. 9, 1999]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.834]
[Page 85-86]
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. 172.834 Ethoxylated mono- and diglycerides.
The food additive ethoxylated mono-and diglycerides (polyoxyethylene
(20) mono- and diglycerides of fatty acids) (polyglycerate 60) may be
safely used in food in accordance with the following prescribed
conditions:
(a) The food additive is manufactured by:
(1) Glycerolysis of edible fats primarily composed of stearic,
palmitic, and myristic acids; or
(2) Direct esterification of glycerol with a mixture of primarily
stearic, palmitic, and myristic acids;
to yield a product with less than 0.3 acid number and less than 0.2
percent water, which is then reacted with ethylene oxide.
(b) The additive meets the following specifications:
Saponification number, 65-75.
Acid number, 0-2.
Hydroxyl number, 65-80.
Oxyethylene content, 60.5-65.0 percent.
(c) The additive is used or intended for use in the following foods
when standards of identity established under section 401 of the Act do
not preclude such use:
------------------------------------------------------------------------
Use Limitations
------------------------------------------------------------------------
1. As an emulsifier in pan-release agents Not to exceed levels
for and as a dough conditioner in yeast- required to produce the
leavened bakery products. intended effects, total not
to exceed 0.5 percent by
weight of the flour used.
2. As an emulsifier in cakes and cake Not to exceed 0.5 percent by
mixes. weight of the dry
ingredients.
3. As an emulsifier in whipped vegetable Not to exceed 0.45 percent
oil toppings and topping mixes. by weight of the finished
whipped vegetable oil
toppings.
4. As an emulsifier in icings and icing Not to exceed 0.5 percent by
mixes. weight of the finished
icings.
5. As an emulsifier in frozen desserts.... Not to exceed 0.2 percent by
weight of the finished
frozen desserts.
6. As an emulsifier in edible vegetable Not to exceed 0.4 percent by
fat-water emulsions intended for use as weight of the finished
substitutes for milk or cream in beverage vegetable fat-water
coffee. emulsions.
------------------------------------------------------------------------
(d) When the name "polyglycerate 60" is used in labeling it shall
be followed by either "polyoxyethylene (20) mono-and diglycerides of
fatty acids"
[[Page 86]]
or "ethoxylated mono- and diglycerides" in parentheses.
[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 37973, July 26, 1977;
50 FR 49536, Dec. 3, 1985]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.836]
[Page 86-87]
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. 172.836 Polysorbate 60.
The food additive polysorbate 60 (polyoxyethylene (20) sorbitan
monostearate) which is a mixture of polyoxyethylene ethers of mixed
partial stearic and palmitic acid esters of sorbitol anhydrides and
related compounds, may be safely used in food in accordance with the
following prescribed conditions:
(a) The food additive is manufactured by reacting stearic acid
(usually containing associated fatty acids, chiefly palmitic) with
sorbitol to yield a product with a maximum acid number of 10 and a
maximum water content of 0.2 percent, which is then reacted with
ethylene oxide.
(b) The food additive meets the following specifications:
Saponification number 45-55.
Acid number 0-2.
Hydroxyl number 81-96.
Oxyethylene content 65 percent-69.5 percent.
(c) It is used or intended for use as follows:
(1) As an emulsifier in whipped edible oil topping with or without
one or a combination of the following:
(i) Sorbitan monostearate;
(ii) Polysorbate 65;
(iii) Polysorbate 80;
whereby the maximum amount of the additive or additives used does not
exceed 0.4 percent of the weight of the finished whipped edible oil
topping; except that a combination of the additive with sorbitan
monostearate may be used in excess of 0.4 percent, provided that the
amount of the additive does not exceed 0.77 percent and the amount of
sorbitan monostearate does not exceed 0.27 percent of the weight of the
finished whipped edible oil topping.
(2) As an emulsifier in cakes and cake mixes, with or without one or
a combination of the following:
(i) Polysorbate 65.
(ii) Sorbitan monostearate.
When used alone, the maximum amount of polysorbate 60 shall not exceed
0.46 percent of the cake or cake mix, on a dry-weight basis. When used
with polysorbate 65 and/or sorbitan monostearate, it shall not exceed
0.46 percent, nor shall the polysorbate 65 exceed 0.32 percent or the
sorbitan monostearate exceed 0.61 percent, and no combination of these
emulsifiers shall exceed 0.66 percent of the cake or cake mix, all
calculated on a dry-weight basis.
(3) As an emulsifier, alone or in combination with sorbitan
monostearate, in nonstandardized confectionery coatings and standardized
cacao products specified in Secs. 163.123, 163.130, 163.135, 163.140,
163.145, and 163.150 of this chapter, as follows:
(i) It is used alone in an amount not to exceed 0.5 percent of the
weight of the finished nonstandardized confectionery coating or
standardized cacao product.
(ii) It is used with sorbitan monostearate in any combination of up
to 0.5 percent of polysorbate 60 and up to 1 percent of sorbitan
monostearate: Provided, That the total combination does not exceed 1
percent of the weight of the finished nonstandardized confectionery
coating or standardized cacao product.
(4) [Reserved]
(5) As an emulsifier in cake icings and cake fillings, with or
without one or a combination of the following:
(i) Polysorbate 65.
(ii) Sorbitan monostearate.
When used alone, the maximum amount of polysorbate 60 shall not exceed
0.46 percent of the weight of the cake icings and cake fillings. When
used with polysorbate 65 and/or sorbitan monostearate, it shall not
exceed 0.46 percent, nor shall the polysorbate 65 exceed 0.32 percent or
the sorbitan monostearate exceed 0.7 percent, and no combination of
these emulsifiers shall exceed 1 percent of the weight of the cake icing
or cake filling.
(6) To impart greater opacity to sugar-type confection coatings
whereby the maximum amount of the additive does not exceed 0.2 percent
of the weight of the finished sugar coating.
(7) As an emulsifier in nonstandardized dressings whereby the
maximum amount of the additive does not exceed 0.3 percent of the weight
of the finished dressings.
[[Page 87]]
(8) As an emulsifier, alone or in combination with polysorbate 80,
in shortenings and edible oils intended for use in foods as follows,
when standards of identity established under section 401 of the act do
not preclude such use:
(i) It is used alone in an amount not to exceed 1 percent of the
weight of the finished shortening or oil.
(ii) It is used with polysorbate 80 in any combination providing no
more than 1 percent of polysorbate 60 and no more than 1 percent of
polysorbate 80, provided that the total combination does not exceed 1
percent of the finished shortening or oil.
(iii) The 1-percent limitation specified in paragraph (c)(8) (i) and
(ii) of this section may be exceeded in premix concentrates of
shortening or edible oil if the labeling complies with the requirements
of paragraph (d) of this section.
(9) As an emulsifier in solid-state, edible vegetable fat-water
emulsions intended for use as substitutes for milk or cream in beverage
coffee, with or without one or a combination of the following:
(i) Polysorbate 65.
(ii) Sorbitan monostearate.
The maximum amount of the additive or additives shall not exceed 0.4
percent by weight of the finished edible vegetable fat-water emulsion.
(10) As a foaming agent in nonalcoholic mixes, to be added to
alcoholic beverages in the preparation of mixed alcoholic drinks, at a
level not to exceed 4.5 percent by weight of the nonalcoholic mix.
(11) As a dough conditioner in yeast-leavened bakery products in an
amount not to exceed 0.5 percent by weight of the flour used.
(12) As an emulsifier, alone or in combination with sorbitan
monostearate, in the minimum quantity required to accomplish the
intended effect, in formulations of white mineral oil conforming with
Sec. 172.878 and/or petroleum wax conforming with Sec. 172.886 for use
as protective coatings on raw fruits and vegetables.
(13) As a dispersing agent in artificially sweetened gelatin
desserts and in artificially sweetened gelatin dessert mixes, whereby
the amount of the additive does not exceed 0.5 percent on a dry-weight
basis.
(14) As an emulsifier in chocolate flavored syrups, whereby the
maximum amount of the additive does not exceed 0.05 percent in the
finished product.
(15) As a surfactant and wetting agent for natural and artificial
colors in food as follows:
(i) In powdered soft drink mixes in an amount not to exceed 4.5
percent by weight of the mix.
(ii) In sugar-based gelatin dessert mixes in an amount not to exceed
0.5 percent by weight of the mix.
(iii) In artificially sweetened gelatin dessert mixes in an amount
not to exceed 3.6 percent by weight of the mix.
(iv) In sugar-based pudding mixes in an amount not to exceed 0.5
percent by weight of the mix.
(v) In artificially sweetened pudding mixes in an amount not to
exceed 0.5 percent by weight of the mix.
(16) As an emulsifier in ice cream, frozen custard, fruit sherbet,
and nonstandardized frozen desserts when used alone or in combination
with polysorbate 65 and/or polysorbate 80, whereby the maximum amount of
the additives, alone or in combination, does not exceed 0.1 percent of
the finished frozen dessert.
(d) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of the additive and any intermediate premixes shall
bear:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in
any intermediate premixes.
(2) The label or labeling shall bear adequate directions to provide
a final product that complies with the limitations prescribed in
paragraph (c) of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 25, 1978; 45
FR 58836, Sept. 5, 1980; 46 FR 8466, Jan. 27, 1981; 64 FR 57976, Oct.
28, 1999]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.838]
[Page 87-88]
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. 172.838 Polysorbate 65.
The food additive polysorbate 65 (polyoxyethylene (20) sorbitan
tristearate), which is a mixture of polyoxyethylene ethers of mixed
stearic acid esters of sorbitol anhydrides and related compounds, may be
safely
[[Page 88]]
used in food in accordance with the following prescribed conditions:
(a) The food additive is manufactured by reacting stearic acid
(usually containing associated fatty acids, chiefly palmitic) with
sorbitol to yield a product with a maximum acid number of 15 and a
maximum water content of 0.2 percent, which is then reacted with
ethylene oxide.
(b) The food additive meets the following specifications:
Saponification number 88-98.
Acid number 0-2.
Hydroxyl number 44-60.
Oxyethylene content 46 percent-50 percent.
(c) The additive is used, or intended for use, as follows:
(1) As an emulsifier in ice cream, frozen custard, ice milk, fruit
sherbet and nonstandardized frozen desserts when used alone or in
combination with polysorbate 80, whereby the maximum amount of the
additives, alone or in combination, does not exceed 0.1 percent of the
finished frozen dessert.
(2) As an emulsifier in cakes and cake mixes, with or without one or
a combination of the following:
(i) Sorbitan monostearate.
(ii) Polysorbate 60.
When used alone, the maximum amount of polysorbate 65 shall not exceed
0.32 percent of the cake or cake mix, on a dry-weight basis. When used
with sorbitan monostearate and/or polysorbate 60, it shall not exceed
0.32 percent, nor shall the sorbitan monostearate exceed 0.61 percent or
the polysorbate 60 exceed 0.46 percent, and no combination of these
emulsifiers shall exceed 0.66 percent of the cake or cake mix, all
calculated on a dry-weight basis.
(3) As an emulsifier in whipped edible oil topping with or without
one or a combination of the following:
(i) Sorbitan monostearate;
(ii) Polysorbate 60;
(iii) Polysorbate 80;
whereby the maximum amount of the additive or additives used does not
exceed 0.4 percent of the weight of the finished whipped edible oil
topping.
(4) As an emulsifier in solid-state, edible vegetable fat-water
emulsions intended for use as substitutes for milk or cream in beverage
coffee, with or without one or a combination of the following:
(i) Sorbitan monostearate.
(ii) Polysorbate 60.
The maximum amount of the additive or additives shall not exceed 0.4
percent by weight of the finished edible vegetable fat-water emulsion.
(5) As an emulsifier in cake icings and cake fillings, with or
without one or a combination of the following:
(i) Sorbitan monostearate.
(ii) Polysorbate 60.
When used alone, the maximum amount of polysorbate 65 shall not exceed
0.32 percent of the weight of the cake icing or cake filling. When used
with sorbitan monostearate and/or polysorbate 60, it shall not exceed
0.32 percent, nor shall the sorbitan monostearate exceed 0.7 percent or
the polysorbate 60 exceed 0.46 percent, and no combination of these
emulsifiers shall exceed 1 percent of the weight of the cake icing or
cake filling.
(d) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of the additive and any intermediate premixes shall
bear:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in
any intermediate premixes.
(2) The label or labeling shall bear adequate directions to provide
a final product that complies with the limitations prescribed in
paragraph (c) of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.840]
[Page 88-90]
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. 172.840 Polysorbate 80.
The food additive polysorbate 80 (polyoxyethylene (20) sorbitan
monooleate), which is a mixture of polyoxyethylene ethers of mixed
partial oleic acid esters of sorbitol anhydrides and related compounds,
may be safely used in food in accordance with the following prescribed
conditions:
(a) The food additive is manufactured by reacting oleic acid
(usually containing associated fatty acids) with sorbitol to yield a
product with a maximum acid number of 7.5 and a maximum water content of
0.5 percent,
[[Page 89]]
which is then reacted with ethylene oxide.
(b) The food additive meets the following specifications:
Saponification number 45-55.
Acid number 0-2.
Hydroxyl number 65-80.
Oxyethylene content 65 percent-69.5 percent.
(c) The additive is used or intended for use as follows:
(1) An emulsifier in ice cream, frozen custard, ice milk, fruit
sherbet, and nonstandardized frozen desserts, when used alone or in
combination with polysorbate 65 whereby the maximum amount of the
additives, alone or in combination, does not exceed 0.1 percent of the
finished frozen dessert.
(2) In yeast-defoamer formulations whereby the maximum amount of the
additive does not exceed 4 percent of the finished yeast defoamer and
the maximum amount of the additive in the yeast from such use does not
exceed 4 parts per million.
(3) As a solubilizing and dispersing agent in pickles and pickle
products, whereby the maximum amount of the additive does not exceed 500
parts per million.
(4) As a solubilizing and dispersing agent in:
(i) Vitamin-mineral preparations containing calcium caseinate in the
absence of fat-soluble vitamins, whereby the maximum intake of
polysorbate 80 shall not exceed 175 milligrams from the recommended
daily dose of the preparations.
(ii) Fat-soluble vitamins in vitamin and vitamin-mineral
preparations containing no calcium caseinate, whereby the maximum intake
of polysorbate 80 shall not exceed 300 milligrams from the recommended
daily dose of the preparations.
(iii) In vitamin-mineral preparations containing both calcium
caseinate and fat-soluble vitamins, whereby the maximum intake of
polysorbate 80 shall not exceed 475 milligrams from the recommended
daily dose of the preparations.
(5) As a surfactant in the production of coarse crystal sodium
chloride whereby the maximum amount of the additive in the finished
sodium chloride does not exceed 10 parts per million.
(6) In special dietary foods, as an emulsifier for edible fats and
oils, with directions for use which provide for the ingestion of not
more than 360 milligrams of polysorbate 80 per day.
(7) As a solubilizing and dispersing agent for dill oil in canned
spiced green beans, not to exceed 30 parts per million.
(8) As an emulsifier, alone or in combination with polysorbate 60,
in shortenings and edible oils intended for use in foods as follows,
when standards of identity established under section 401 of the act do
not preclude such use:
(i) It is used alone in an amount not to exceed 1 percent of the
weight of the finished shortening or oil.
(ii) It is used with polysorbate 60 in any combination providing no
more than 1 percent of polysorbate 80 and no more than 1 percent of
polysorbate 60, provided that the total combination does not exceed 1
percent of the finished shortening or oil.
(iii) The 1-percent limitation specified in paragraph (c)(8) (i) and
(ii) of this section may be exceeded in premix concentrates of
shortening or edible oil if the labeling complies with the requirements
of paragraph (d) of this section.
(9) As an emulsifier in whipped edible oil topping with or without
one or a combination of the following:
(i) Sorbitan monostearate;
(ii) Polysorbate 60;
(iii) Polysorbate 65;
whereby the maximum amount of the additive or additives used does not
exceed 0.4 percent of the weight of the finished whipped edible oil
topping.
(10) It is used as a wetting agent in scald water for poultry
defeathering, followed by potable water rinse. The concentration of the
additive in the scald water does not exceed 0.0175 percent.
(11) As a dispersing agent in gelatin desserts and in gelatin
dessert mixes, whereby the amount of the additive does not exceed 0.082
percent on a dry-weight basis.
(12) As an adjuvant added to herbicide use and plant-growth
regulator use dilutions by a grower or applicator prior to application
of such dilutions to the growing crop. Residues resulting
[[Page 90]]
from such use are exempt from the requirement of a tolerance. When so
used or intended for use, the additive shall be exempt from the
requirements of paragraph (d)(1) of this section.
(13) As a defoaming agent in the preparation of the creaming mixture
for cottage cheese and lowfat cottage cheese, as identified in
Secs. 133.128 and 133.131 of this chapter, respectively, whereby the
amount of the additive does not exceed .008 percent by weight of the
finished products.
(14) As a surfactant and wetting agent for natural and artificial
colors for use in barbecue sauce where the level of the additive does
not exceed 0.005 percent by weight of the barbecue sauce.
(d) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of the additive and any intermediate premixes shall
bear:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in
any intermediate premixes.
(2) The label or labeling shall bear adequate directions to provide
a final product that complies with the limitations prescribed in
paragraph (c) of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978; 45
FR 58835, Sept. 5, 1980; 46 FR 8466, Jan. 27, 1981]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.841]
[Page 90]
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. 172.841 Polydextrose.
Polydextrose as identified in this section may be safely used in
food in accordance with the following prescribed conditions:
(a)(1) Polydextrose (CAS Reg. No. 68424-04-4) is a partially
metabolizable water-soluble polymer prepared by the condensation of a
melt which consists either of approximately 89 percent D-glucose, 10
percent sorbitol, and 1 percent citric acid or of approximately 90
percent D-glucose, 10 percent sorbitol, and 0.1 percent phosphoric acid,
on a weight basis.
(2) Polydextrose may be partially neutralized with potassium
hydroxide, or partially reduced by transition metal catalytic
hydrogenation in aqueous solution.
(b) The additive meets the specifications of the "Food Chemicals
Codex," 4th ed. (1996), pp. 297-300, which is incorporated by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are
available from the National Academy Press, 2101 Constitution Ave. NW.,
Washington, DC 20418, or 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 Office of the
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(c) Polydextrose is used in accordance with current good
manufacturing practices as a bulking agent, formulation aid, humectant,
and texturizer in the following foods when standards of identity
established under section 401 of the act do not preclude such use:
(1) Baked goods and baking mixes (restricted to fruit, custard, and
pudding-filled pies, cakes, cookies, and similar baked products);
(2) Chewing gum;
(3) Confections and frostings;
(4) Dressings for salads;
(5) Film coatings on single and multiple vitamin and mineral
supplement tablets;
(6) Frozen dairy desserts and mixes;
(7) Fruit and water ices;
(8) Fruit spreads;
(9) Gelatins, puddings and fillings;
(10) Hard and soft candy;
(11) Peanut spread;
(12) Sweet sauces, toppings, and syrups;
(13) Tablespreads.
(d) If the food containing the additive purports to be or is
represented for special dietary uses, it shall be labeled in compliance
with part 105 of this chapter.
(e) The label and labeling of food a single serving of which would
be expected to exceed 15 grams of the additive shall bear the statement:
"Sensitive individuals may experience a laxative effect from excessive
consumption of this product".
[46 FR 30081, June 5, 1981, as amended at 59 FR 37421, July 22, 1994; 60
FR 54425, Oct. 24, 1995; 61 FR 14480, Apr. 2, 1996; 62 FR 30985, June 6,
1997; 63 FR 57597, Oct. 28, 1998; 65 FR 64605, Oct. 30, 2000; 65 FR
79719, Dec. 20, 2000]
[[Page 91]]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.842]
[Page 91-92]
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. 172.842 Sorbitan monostearate.
The food additive sorbitan monostearate, which is a mixture of
partial stearic and palmitic acid esters of sorbitol anhydrides, may be
safely used in or on food in accordance with the following prescribed
conditions:
(a) The food additive is manufactured by reacting stearic acid
(usually containing associated fatty acids, chiefly palmitic) with
sorbitol to yield essentially a mixture of esters.
(b) The food additive meets the following specifications:
Saponification number, 147-157
Acid number, 5-10
Hydroxyl number, 235-260
(c) It is used or intended for use, alone or in combination with
polysorbate 60 as follows:
(1) As an emulsifier in whipped edible oil topping with or without
one or a combination of the following:
(i) Polysorbate 60;
(ii) Polysorbate 65;
(iii) Polysorbate 80;
whereby the maximum amount of the additive or additives used does not
exceed 0.4 percent of the weight of the finished whipped edible oil
topping; except that a combination of the additive with polysorbate 60
may be used in excess of 0.4 percent: Provided, That the amount of the
additive does not exceed 0.27 percent and the amount of polysorbate 60
does not exceed 0.77 percent of the weight of the finished whipped
edible oil topping.
(2) As an emulsifier in cakes and cake mixes, with or without one or
a combination of the following:
(i) Polysorbate 65.
(ii) Polysorbate 60.
When used alone, the maximum amount of sorbitan monostearate shall not
exceed 0.61 percent of the cake or cake mix, on a dry-weight basis. When
used with polysorbate 65 and/or polysorbate 60, it shall not exceed 0.61
percent, nor shall the polysorbate 65 exceed 0.32 percent or the
polysorbate 60 exceed 0.46 percent, and no combination of the
emulsifiers shall exceed 0.66 percent of the weight of the cake or cake
mix, calculated on a dry-weight basis.
(3) As an emulsifier, alone or in combination with polysorbate 60 in
nonstandardized confectionery coatings and standardized cacao products
specified in Secs. 163.123, 163.130, 163.135, 163.140, 163.145, and
163.150 of this chapter, as follows:
(i) It is used alone in an amount not to exceed 1 percent of the
weight of the finished nonstandardized confectionery coating or
standardized cacao product.
(ii) It is used with polysorbate 60 in any combination of up to 1
percent sorbitan monostearate and up to 0.5 percent polysorbate 60
provided that the total combination does not exceed 1 percent of the
weight of the finished nonstandardized confectionery coating or
standardized cacao product.
(4) As an emulsifier in cake icings and cake fillings, with or
without one or a combination of the following:
(i) Polysorbate 65.
(ii) Polysorbate 60.
When used alone, the maximum amount of sorbitan monostearate shall not
exceed 0.7 percent of the weight of the cake icing or cake filling. When
used with polysorbate 65 and/or polysorbate 60, it shall not exceed 0.7
percent, nor shall the polysorbate 65 exceed 0.32 percent or the
polysorbate 60 exceed 0.46 percent, and no combination of these
emulsifiers shall exceed 1 percent of the weight of the cake icing or
cake filling.
(5) As an emulsifier in solid-state, edible vegetable fat-water
emulsions intended for use as substitutes for milk or cream in beverage
coffee, with or without one or a combination of the following:
(i) Polysorbate 60.
(ii) Polysorbate 65.
The maximum amount of the additive or additives shall not exceed 0.4
percent by weight of the finished edible vegetable fat-water emulsion.
(6) It is used alone as a rehydration aid in the production of
active dry yeast in an amount not to exceed 1 percent by weight of the
dry yeast.
(7) As an emulsifier, alone or in combination with polysorbate 60,
in the minimum quantity required to accomplish the intended effect, in
formulations of white mineral oil conforming with Sec. 172.878 and/or
petroleum wax
[[Page 92]]
conforming with Sec. 172.886 for use as protective coatings on raw
fruits and vegetables.
(d) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of the additive and any intermediate premixes shall
bear:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in
any intermediate premixes.
(2) The label or labeling shall bear adequate directions to provide
a final product that complies with the limitations prescribed in
paragraph (c) of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.844]
[Page 92]
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. 172.844 Calcium stearoyl-2-lactylate.
The food additive calcium stearoyl-2-lactylate may be safely used in
or on food in accordance with the following prescribed conditions:
(a) The additive, which is a mixture of calcium salts of stearoyl
lactylic acids and minor proportions of other calcium salts of related
acids, is manufactured by the reaction of stearic acid and lactic acid
and conversion to the calcium salts.
(b) The additive meets the following specifications:
Acid number, 50-86.
Calcium content, 4.2-5.2 percent.
Lactic acid content, 32-38 percent.
Ester number, 125-164.
(c) It is used or intended for use as follows:
(1) As a dough conditioner in yeast-leavened bakery products and
prepared mixes for yeast-leavened bakery products in an amount not to
exceed 0.5 part for each 100 parts by weight of flour used.
(2) As a whipping agent in:
(i) Liquid and frozen egg white at a level not to exceed 0.05
percent.
(ii) Dried egg white at a level not to exceed 0.5 percent.
(iii) Whipped vegetable oil topping at a level not to exceed 0.3
percent of the weight of the finished whipped vegetable oil topping.
(3) As a conditioning agent in dehydrated potatoes in an amount not
to exceed 0.5 percent by weight thereof.
(d) To assure safe use of the additive:
(1) The label and labeling of the food additive and any intermediate
premix prepared therefrom shall bear, in addition to the other
information required by the act, the following:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in
any intermediate premixes.
(2) The label or labeling of the food additive shall also bear
adequate directions of use to provide a finished food that complies with
the limitations prescribed in paragraph (c) of this section.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.846]
[Page 92-93]
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. 172.846 Sodium stearoyl lactylate.
The food additive sodium stearoyl lactylate (CAS Reg. No. 25-383-
997) may be safely used in food in accordance with the following
prescribed conditions:
(a) The additive, which is a mixture of sodium salts of stearoyl
lactylic acids and minor proportions of sodium salts of related acids,
is manufactured by the reaction of stearic acid and lactic acid and
conversion to the sodium salts.
(b) The additive meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), pp. 300-301, 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
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) It is used or intended for use as follows when standards of
identity established under section 401 of the Act do not preclude such
use:
(1) As a dough strengthener, emulsifier, or processing aid in baked
products, pancakes, and waffles, in an amount not to exceed 0.5 part for
each 100 parts by weight of flour used.
(2) As a surface-active agent, emulsifier, or stabilizer in icings,
fillings, puddings, and toppings, at a level not to exceed 0.2 percent
by weight of the finished food.
(3) As an emulsifier or stabilizer in liquid and solid edible fat-
water emulsions intended for use as substitutes for milk or cream in
beverage coffee, at a level not to exceed 0.3 percent by
[[Page 93]]
weight of the finished edible fat-water emulsion.
(4) As a formulation aid, processing aid, or surface-active agent in
dehydrated potatoes, in an amount not to exceed 0.5 percent of the dry
weight of the food.
(5) As an emulsifier, stabilizer, or texturizer in snack dips, at a
level not to exceed 0.2 percent by weight of the finished product.
(6) As an emulsifier, stabilizer, or texturizer in cheese
substitutes and imitations and cheese product substitutes and
imitations, at a level not to exceed 0.2 percent by weight of the
finished food.
(7) As an emulsifier, stabilizer, or texturizer in sauces or
gravies, and the products containing the same, in an amount not to
exceed 0.25 percent by weight of the finished food.
(8) In prepared mixes for each of the foods listed in paragraphs (c)
(1) through (7) of this section, provided the additive is used only as
specified in each of those paragraphs.
(9) As an emulsifier, stabilizer, or texturizer in cream liqueur
drinks, at a level not to exceed 0.5 percent by weight of the finished
product.
[45 FR 51767, Aug. 5, 1980, as amended at 49 FR 10105, Mar. 19, 1984; 50
FR 49536, Dec. 3, 1985; 51 FR 1495, Jan. 14, 1986; 51 FR 3333, Jan. 27,
1986; 65 FR 60859, Oct. 13, 2000]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.848]
[Page 93]
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. 172.848 Lactylic esters of fatty acids.
Lactylic esters of fatty acids may be safely used in food in
accordance with the following prescribed conditions:
(a) They are prepared from lactic acid and fatty acids meeting the
requirements of Sec. 172.860(b) and/or oleic acid derived from tall oil
fatty acids meeting the requirements of Sec. 172.862.
(b) They are used as emulsifiers, plasticizers, or surface-active
agents in the following foods, when standards of identity do not
preclude their use:
------------------------------------------------------------------------
Foods Limitations
------------------------------------------------------------------------
Bakery mixes.............................. ............................
Baked products............................ ............................
Cake icings, fillings, and toppings....... ............................
Dehydrated fruits and vegetables.......... ............................
Dehydrated fruit and vegetable juices..... ............................
Edible vegetable fat-water emulsions...... As substitutes for milk or
cream in beverage coffee.
Frozen desserts........................... ............................
Liquid shortening......................... For household use.
Pancake mixes............................. ............................
Precooked instant rice.................... ............................
Pudding mixes............................. ............................
------------------------------------------------------------------------
(c) They are used in an amount not greater than required to produce
the intended physical or technical effect, and they may be used with
shortening and edible fats and oils when such are required in the foods
identified in paragraph (b) of this section.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.850]
[Page 93]
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. 172.850 Lactylated fatty acid esters of glycerol and propylene glycol.
The food additive lactylated fatty acid esters of glycerol and
propylene glycol may be safely used in food in accordance with the
following prescribed conditions:
(a) The additive is a mixture of esters produced by the lactylation
of a product obtained by reacting edible fats or oils with propylene
glycol.
(b) The additive meets the following specifications: Water insoluble
combined lactic acid, 14-18 percent; and acid number, 12 maximum.
(c) It is used in amounts not in excess of that reasonably required
to produce the intended physical effect as an emulsifier, plasticizer,
or surface-active agent in food.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.852]
[Page 93]
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. 172.852 Glyceryl-lacto esters of fatty acids.
Glyceryl-lacto esters of fatty acids (the lactic acid esters of
mono- and diglycerides) may be safely used in food in accordance with
the following prescribed conditions:
(a) They are manufactured from glycerin, lactic acid, and fatty
acids conforming with Sec. 172.860 and/or oleic acid derived from tall
oil fatty acids conforming with Sec. 172.862 and/or edible fats and
oils.
(b) They are used in amounts not in excess of those reasonably
required to accomplish their intended physical or technical effect as
emulsifiers and plasticizers in food.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.854]
[Page 93-94]
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. 172.854 Polyglycerol esters of fatty acids.
Polyglycerol esters of fatty acids, up to and including the
decaglycerol
[[Page 94]]
esters, may be safely used in food in accordance with the following
prescribed conditions:
(a) They are prepared from corn oil, cottonseed oil, lard, palm oil
from fruit, peanut oil, safflower oil, sesame oil, soybean oil, and
tallow and the fatty acids derived from these substances (hydrogenated
and nonhydrogenated) meeting the requirements of Sec. 172.860(b) and/or
oleic acid derived from tall oil fatty acids meeting the requirements of
Sec. 172.862.
(b) They are used as emulsifiers in food, in amounts not greater
than that required to produce the intended physical or technical effect.
(c) Polyglycerol esters of a mixture of stearic, oleic, and coconut
fatty acids are used as a cloud inhibitor in vegetable and salad oils
when use is not precluded by standards of identity. The fatty acids used
in the production of the polyglycerol esters meet the requirements of
Sec. 172.860(b), and the polyglycerol esters are used at a level not in
excess of the amount required to perform its cloud-inhibiting effect.
Oleic acid derived from tall oil fatty acids conforming with
Sec. 172.862 may be used as a substitute for or together with the oleic
acid permitted by this paragraph.
(d) Polyglycerol esters of butter oil fatty acids are used as
emulsifiers in combination with other approved emulsifiers in dry,
whipped topping base. The fatty acids used in the production of the
polyglycerol esters meet the requirements of Sec. 172.860(b), and the
polyglycerol esters are used at a level not in excess of the amount
required to perform their emulsifying effect.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.856]
[Page 94]
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. 172.856 Propylene glycol mono- and diesters of fats and fatty acids.
Propylene glycol mono- and diesters of fats and fatty acids may be
safely used in food, subject to the following prescribed conditions:
(a) They are produced from edible fats and/or fatty acids in
compliance with Sec. 172.860 and/or oleic acid derived from tall oil
fatty acids in compliance with Sec. 172.862.
(b) They are used in food in amounts not in excess of that
reasonably required to produce their intended effect.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.858]
[Page 94-95]
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. 172.858 Propylene glycol alginate.
The food additive propylene glycol alginate (CAS Reg. No. 9005-37-2)
may be used as an emulsifier, flavoring adjuvant, formulation aid,
stabilizer, surfactant, or thickener in foods in accordance with the
following prescribed conditions:
(a) The additive meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 256, which is incorporated by reference (copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408), and the additional specification that it shall
have up to 85 percent of the carboxylic acid groups esterified with the
remaining groups either free or neutralized.
(b) The additive is used or intended for use in the following foods
as defined in Sec. 170.3(n) of this chapter, when standards of identity
established under section 401 of the act do not preclude such use:
(1) As a stabilizer in frozen dairy desserts, in fruit and water
ices, and in confections and frostings at a level not to exceed 0.5
percent by weight of the finished product.
(2) As an emulsifier, flavoring adjuvant, stabilizer, or thickener
in baked goods at a level not to exceed 0.5 percent by weight of the
finished product.
(3) As an emulsifier, stabilizer, or thickener in cheeses at a level
not to exceed 0.9 percent by weight of the finished product.
(4) As an emulsifier, stabilizer, or thickener in fats and oils at a
level not to exceed 1.1 percent by weight of the finished product.
(5) As an emulsifier, stabilizer, or thickener in gelatins and
puddings at a level not to exceed 0.6 percent by weight of the finished
product.
(6) As a stabilizer or thickener in gravies and in sweet sauces at a
level not to exceed 0.5 percent by weight of the finished product.
(7) As a stabilizer in jams and jellies at a level not to exceed 0.4
percent by weight of the finished product.
(8) As an emulsifier, stabilizer, or thickener in condiments and
relishes
[[Page 95]]
at a level not to exceed 0.6 percent by weight of the finished product.
(9) As a flavoring adjunct or adjuvant in seasonings and flavors at
a level not to exceed 1.7 percent by weight of the finished product.
(10) As an emulsifier, flavoring adjuvant, formulation aid,
stabilizer or thickener, or surface active agent in other foods, where
applicable, at a level not to exceed 0.3 percent by weight of the
finished product.
(c) To ensure safe use of the additive, the label of the food
additive container shall bear, in addition to the other information
required by the act:
(1) The name of the additive, "propylene glycol alginate" or
"propylene glycol ester of alginic acid".
(2) Adequate directions for use.
[47 FR 29950, July 9, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.859]
[Page 95-96]
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. 172.859 Sucrose fatty acid esters.
Sucrose fatty acid esters identified in this section may be safely
used in accordance with the following prescribed conditions:
(a) Sucrose fatty acid esters are the mono-, di-, and tri-esters of
sucrose with fatty acids and are derived from sucrose and edible tallow
or hydrogenated edible tallow or edible vegetable oils. The only
solvents which may be used in the preparation of sucrose fatty acid
esters are those generally recognized as safe in food or regulated for
such use by an appropriate section in this part. Ethyl acetate or methyl
ethyl ketone or dimethyl sulfoxide and isobutyl alcohol (2-methyl-1-
propanol) may be used in the preparation of sucrose fatty acid esters.
(b) Sucrose fatty acid esters meet the following specifications:
(1) The total content of mono-, di-, and tri-esters is not less than
80 percent as determined by a method title "Sucrose Fatty Acid Esters,
Method of Assay," which is incorporated by reference. Copies are
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(2) The free sucrose content is not more than 5 percent as
determined by Test S.2 in the method titled "Sucrose Fatty Acid Esters,
Method of Assay," which is incorporated by reference. The availability
of this incorporation by reference is given in paragraph (b)(1) of this
section.
(3) The acid value is not more than 6.
(4) The residue on ignition (sulfated ash) is not more than 2
percent.
(5) The total ethyl acetate content is not more than 350 parts per
million as determined by a method titled "Determination of Ethyl
Acetate," which is incorporated by reference. Copies are available from
the Center for Food Safety and Applied Nutrition (HFS-200), Food and
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408.
(6) Arsenic is not more than 3 parts per million.
(7) Total heavy metal content (as Pb) is not more than 50 parts per
million.
(8) Lead is not more than 10 parts per million.
(9) The total content of methyl ethyl ketone or of methanol shall
not be more than 10 parts per million as determined by a method titled
"Methyl Ethyl Ketone Test; Methyl Alcohol Test," which is incorporated
by reference. Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(10) The total dimethyl sulfoxide content is not more than 2 parts
per million as determined by a method entitled "Determination of
Dimethyl Sulfoxide," which is incorporated by reference. Copies are
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(11) The total isobuytl alcohol (2-methyl-1-propanol) content is not
more than 10 parts per million as determined by a method entitled
"Determination
[[Page 96]]
of Isobutyl Alcohol," which is incorporated by reference. Copies are
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(c) Sucrose fatty acid esters may be used as follows when standards
of identity established under section 401 of the Federal Food, Drug, and
Cosmetic Act do not preclude such use:
(1) As emulsifiers as defined in Sec. 170.3(o)(8) of this chapter,
or as stabilizers as defined in Sec. 170.3(o)(28) of this chapter, in
baked goods and baking mixes as defined in Sec. 170.3(n)(1) of this
chapter, in chewing gum as defined in Sec. 170.3(n)(6) of this chapter,
in coffee and tea beverages with added dairy ingredients and/or dairy
product analogues, in confections and frostings as defined in
Sec. 170.3(n)(9) of this chapter, in dairy product analogues as defined
in Sec. 170.3(n)(10) of this chapter, in frozen dairy desserts and mixes
as defined in Sec. 170.3(n)(20) of this chapter, and in whipped milk
products.
(2) As texturizers as defined in Sec. 170.3(o)(32) of this chapter
in biscuit mixes, in chewing gum as defined in Sec. 170.3(n)(6) of this
chapter, in confections and frostings as defined in Sec. 170.3(n)(9) of
this chapter, and in surimi-based fabricated seafood products.
(3) As components of protective coatings applied to fresh apples,
avocados, bananas, banana plantains, limes, melons (honeydew and
cantaloupe), papaya, peaches, pears, pineapples, and plums to retard
ripening and spoiling.
(d) Sucrose fatty acid esters are used in accordance with current
good manufacturing practice and in an amount not to exceed that
reasonably required to accomplish the intended effect.
[47 FR 55475, Dec. 10, 1982, as amended at 48 FR 38226, Aug. 23, 1983;
52 FR 10883, Apr. 6, 1987; 53 FR 22294, 22297, June 15, 1988; 54 FR
24897, June 12, 1989; 60 FR 44756, Aug. 29, 1995]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.860]
[Page 96-97]
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. 172.860 Fatty acids.
The food additive fatty acids may be safely used in food and in the
manufacture of food components in accordance with the following
prescribed conditions:
(a) The food additive consists of one or any mixture of the
following straight-chain monobasic carboxylic acids and their associated
fatty acids manufactured from fats and oils derived from edible sources:
Capric acid, caprylic acid, lauric acid, myristic acid, oleic acid,
palmitic acid, and stearic acid.
(b) The food additive meets the following specifications:
(1) Unsaponifiable matter does not exceed 2 percent.
(2) It is free of chick-edema factor:
(i) As evidenced during the bioassay method for determining the
chick-edema factor as prescribed in paragraph (c)(2) of this section; or
(ii) As evidenced by the absence of chromatographic peaks with a
retention time relative to aldrin (RA) between 10 and 25, using the gas
chromatographic-electron capture method prescribed in paragraph (c)(3)
of this section. If chromatographic peaks are found with RA values
between 10 and 25, the food additive shall meet the requirements of the
bioassay method prescribed in paragraph (c)(2) of this section for
determining chick-edema factor.
(c) For the purposes of this section:
(1) Unsaponifiable matter shall be determined by the method
described in the 13th Ed. (1980) of the "Official Methods of Analysis
of the Association of Official Analytical Chemists," which is
incorporated by reference. Copies are available from the Association of
Official Analytical Chemists International, 481 North Frederick Ave.,
suite 500, Gaithersburg, MD 20877-2504, or available for inspection at
the Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(2) Chick-edema factor shall be determined by the bioassay method
described in "Official Methods of Analysis of the Association of
Official Analytical Chemists," 13th Ed. (1980), sections 28.127-28.130,
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
[[Page 97]]
examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(3) The gas chromatographic-electron capture method for testing
fatty acids for chick-edema shall be the method described in the
"Journal of the Association of Official Analytical Chemists," Volume
50 (No. 1), pages 216-218 (1967), or the modified method using a
sulfuric acid clean-up procedure, as described in the "Journal of the
Association of the Offical Analytical Chemists," Volume 51 (No. 2),
pages 489-490 (1968), which are incorporated by reference. See paragraph
(c)(2) of this section for availability of these references.
(d) It is used or intended for use as follows:
(1) In foods as a lubricant, binder, and as a defoaming agent in
accordance with good manufacturing practice.
(2) As a component in the manufacture of other food-grade additives.
(e) To assure safe use of the additive, the label and labeling of
the additive and any premix thereof shall bear, in addition to the other
information required by the act, the following:
(1) The common or usual name of the acid or acids contained therein.
(2) The words "food grade," in juxtaposition with and equally as
prominent as the name of the acid.
[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11837, Mar. 19, 1982;
49 FR 10105, Mar. 19, 1984; 54 FR 24897, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.861]
[Page 97]
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. 172.861 Cocoa butter substitute from coconut oil, palm kernel oil, or both oils.
The food additive, cocoa butter substitute from coconut oil, palm
kernel oil, or both oils, may be safely used in food in accordance with
the following conditions:
(a) Cocoa butter substitute from coconut oil, palm kernel oil (CAS
Reg. No. 85665-33-4), or both oils is a mixture of triglycerides. It is
manufactured by esterification of glycerol with food-grade fatty acids
(complying with Sec. 172.860) derived from edible coconut oil, edible
palm kernel oil, or both oils.
(b) The ingredient meets the following specifications:
Acid number: Not to exceed 0.5.
Saponification number: 220 to 260.
Iodine number: Not to exceed 3.
Melting range: 30 to 44 deg.C.
(c) The ingredient is used or intended for use as follows:
(1) As coating material for sugar, table salt, vitamins, citric
acid, succinic acid, and spices; and
(2) In compound coatings, cocoa creams, cocoa-based sweets, toffees,
caramel masses, and chewing sweets as defined in Sec. 170.3 (n)(9) and
(n)(38) of this chapter, except that the ingredient may not be used in a
standardized food unless permitted by the standard of identity.
(d) The ingredient is used in accordance with current good
manufacturing practice and in an amount not to exceed that reasonably
required to accomplish the intended effect.
[56 FR 66970, Dec. 27, 1991; 57 FR 2814, Jan. 23, 1992]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.862]
[Page 97-98]
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. 172.862 Oleic acid derived from tall oil fatty acids.
The food additive oleic acid derived from tall oil fatty acids may
be safely used in food and as a component in the manufacture of food-
grade additives in accordance with the following prescribed conditions:
(a) The additive consists of purified oleic acid separated from
refined tall oil fatty acids.
(b) The additive meets the following specifications:
(1) Specifications for oleic acid prescribed in the "Food Chemicals
Codex." 3d Ed. (1981), pp. 207-208, which is incorporated by reference,
except that titer (solidification point) shall not exceed 13.5 deg.C
and unsaponifiable matter shall not exceed 0.5 percent. Copies of the
material incorporated by reference may be obtained from the National
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may
be examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(2) The resin acid content does not exceed 0.01 as determined by
ASTM method D1240-82, "Standard Test Method for Rosin Acids in Fatty
Acids," which is incorporated by reference. Copies may be obtained from
the American Society for Testing Materials, 1916 Race St., Philadelphia,
PA 19103, or
[[Page 98]]
may be examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(3) The requirements for absence of chick-edema factor as prescribed
in Sec. 172.860.
(c) It is used or intended for use as follows:
(1) In foods as a lubricant, binder, and defoaming agent in
accordance with good manufacturing practice.
(2) As a component in the manufacture of other food-grade additives.
(d) To assure safe use of the additive, the label and labeling of
the additive and any premix thereof shall bear, in addition to the other
information required by the Act, the following:
(1) The common or usual name of the acid.
(2) The words "food grade" in juxtaposition with and equally as
prominent as the name of the acid.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.863]
[Page 98]
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. 172.863 Salts of fatty acids.
The food additive salts of fatty acids may be safely used in food
and in the manufacture of food components in accordance with the
following prescribed conditions:
(a) The additive consists of one or any mixture of two or more of
the aluminum, calcium, magnesium, potassium, and sodium salts of the
fatty acids conforming with Sec. 172.860 and/or oleic acid derived from
tall oil fatty acids conforming with Sec. 172.862.
(b) The food additive is used or intended for use as a binder,
emulsifier, and anticaking agent in food in accordance with good
manufacturing practice.
(c) To assure safe use of the additive, the label and labeling of
the additive and any premix thereof shall bear, in addition to the other
information required by the Act, the following:
(1) The common or usual name of the fatty acid salt or salts
contained therein.
(2) The words "food grade," in juxtaposition with and equally as
prominent as the name of the salt.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.864]
[Page 98-101]
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. 172.864 Synthetic fatty alcohols.
Synthetic fatty alcohols may be safely used in food and in the
synthesis of food components in accordance with the following prescribed
conditions:
(a) The food additive consists of any one of the following fatty
alcohols:
(1) Hexyl, octyl, decyl, lauryl, myristyl, cetyl, and stearyl;
manufactured by fractional distillation of alcohols obtained by a
sequence of oxidation and hydrolysis of organo-aluminums generated by
the controlled reaction of low molecular weight trialkylaluminum with
purified ethylene (minimum 99 percent by volume
C2H4), and utilizing the hydrocarbon solvent as
defined in paragraph (b) of this section, such that:
(i) Hexyl, octyl, decyl, lauryl, and myristyl alcohols contain not
less than 99 percent of total alcohols and not less than 96 percent of
straight chain alcohols. Any nonalcoholic impurities are primarily
paraffins.
(ii) Cetyl and stearyl alcohols contain not less than 98 percent of
total alcohols and not less than 94 percent of straight chain alcohols.
Any nonalcoholic impurities are primarily paraffins.
(iii) The synthetic fatty alcohols contain no more than 0.1 weight
percent of total diols as determined by a method available upon request
from the Commissioner of Food and Drugs.
(2) Hexyl, octyl, and decyl; manufactured by fractional distillation
of alcohols obtained by a sequence of oxidation, hydrolysis, and
catalytic hydrogenation (catalyst consists of copper, chromium, and
nickel) of organo-aluminums generated by the controlled reaction of low
molecular weight trialkylaluminum with purified ethylene (minimum 99
percent by volume C2H4), and utilizing an external
coolant such that these alcohols meet the specifications prescribed in
paragraph (a)(1) (i) and (iii) of this section.
(b) The hydrocarbon solvent used in the process described in
paragraph (a)(1) of this section is a mixture of liquid hydrocarbons
essentially paraffinic in nature, derived from petroleum and refined to
meet the specifications described in paragraph (b)(1) of this section
when subjected to the procedures
[[Page 99]]
described in paragraph (b) (2) and (3) of this section.
(1) The hydrocarbon solvent meets the following specifications:
(i) Boiling-point range: 175 deg.C-275 deg.C.
(ii) Ultraviolet absorbance limits as follows:
------------------------------------------------------------------------
Maximum
absorbance
per
Wavelength (millicrons) centimeter
optical
path
length
------------------------------------------------------------------------
280-289..................................................... 0.15
290-299..................................................... .12
300-359..................................................... .05
360-400..................................................... .02
------------------------------------------------------------------------
(2) Use ASTM method D86-82, "Standard Method for Distillation of
Petroleum Products," which is incorporated by reference, to determine
boiling point range. Copies of the material incorporated by reference
may be obtained from the American Society for Testing Materials, 1916
Race St., Philadelphia, PA 19103, or may be examined at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(3) The analytical method for determining ultraviolet absorbance
limits is as follows:
General Instructions
All glassware should be scrupulously cleaned to remove all organic
matter such as oil, grease, detergent residues, etc. Examine all
glassware, including stoppers and stopcocks, under ultraviolet light to
detect any residual fluorescent contamination. As a precautionary
measure, it is recommended practice to rinse all glassware with purified
isooctane immediately before use. No grease is to be used on stopcocks
or joints. Great care to avoid contamination of hydrocarbon solvent
samples in handling and to assure absence of any extraneous material
arising from inadequate packaging is essential. Because some of the
polynuclear hydrocarbons sought in this test are very susceptible to
photo-oxidation, the entire procedure is to be carried out under subdued
light.
Apparatus
Chromatographic tube. 450 millimeters in length (packing section),
inside diameter 19 millimeters 1 millimeter, equipped with a
wad of clean Pyrex brand filtering wool (Corning Glass Works Catalog No.
3950 or equivalent). The tube shall contain a 250-milliliter reservoir
and a 2-millimeter tetrafluoroethylene polymer stopcock at the opposite
end. Overall length of the tube is 670 millimeters.
Stainless steel rod. 2 feet in length, 2 to 4 millimeters in
diameter.
Vacuum oven. Similar to Labline No. 3610 but modified as follows: A
copper tube one-fourth inch in diameter and 13 inches in length is bent
to a right angle at the 4-inch point and plugged at the opposite end;
eight copper tubes one-eighth inch in diameter and 5 inches in length
are silver soldered in drilled holes (one-eighth inch in diameter) to
the one-fourth-inch tube, one on each side at the 5-, 7.5-, 10- and
12.5-inch points; the one-eighth-inch copper tubes are bent to conform
with the inner periphery of the oven.
Beakers. 250-milliliter and 500-milliliter capacity.
Graduated cylinders. 25-milliliter, 50-milliliter, and 150-
milliliter capacity.
Tuberculin syringe. 1-milliliter capacity, with 3-inch, 22-gauge
needle.
Volumetric flask. 5-milliliter capacity.
Spectrophotometric cells. Fused quartz ground glass stoppered cells,
optical path length in the range of 1.000 centimeter 0.005
centimeter. With distilled water in the cells, determine any absorbance
difference.
Spectrophotometer. Spectral range 250 millimicrons--400 millimicrons
with spectral slit width of 2 millimicrons or less: under instrument
operating conditions for these absorbance measurements, the
spectrophotometer shall also meet the following performance
requirements:
Absorbance repeatability, 0.01 at 0.4 absorbance.
Absorbance accuracy,\1\ 0.05 at 0.4 absorbance.
---------------------------------------------------------------------------
\1\ As determined by using potassium chromate for reference standard
and described in National Bureau of Standards Circular 484,
Spectrophotometry, U.S. Department of Commerce, (1949). The accuracy is
to be determined by comparison with the standard values at 290, 345, and
400 millimicrons. Circular 484 is incorporated by reference. Copies are
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
---------------------------------------------------------------------------
Wavelength repeatability, 0.2 millimicron.
Wavelength accuracy, 1.0 millimicron.
Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in
cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.
[[Page 100]]
Reagents and Materials
Organic solvents. All solvents used throughout the procedure shall
meet the specifications and tests described in this specification. The
isooctane, benzene, hexane, and 1,2-dichloroethane designated in the
list following this paragraph shall pass the following test:
To the specified quantity of solvent in a 250-milliliter beaker, add
1 milliliter of purified n-hexadecane and evaporate in the vacuum oven
under a stream of nitrogen. Discontinue evaporation when not over 1
milliliter of residue remains. (To the residue from benzene add a 5-
milliliter portion of purified isooctane, reevaporate, and repeat once
to insure complete removal of benzene.)
Dissolve the 1 milliliter of hexadecane residue in isooctane and
make to 5 milliliters volume. Determine the absorbance in the 1-
centimeter path length cells compared to isooctane as reference. The
absorbance of the solution of the solvent residue shall not exceed 0.02
per centimeter path length between 280 and 300 m[mu] and shall not
exceed 0.01 per centimeter path length between 300 and 400 m[mu].
Isooctane (2,2,4-trimethylpentane). Use 10 milliliters for the test
described in the preceding paragraph. If necessary, isooctane may be
purified by passage through a column of activated silica gel (Grade 12,
Davison Chemical Co., Baltimore, Md., or equivalent).
Benzene, spectro grade (Burdick and Jackson Laboratories, Inc.,
Muskegon, Mich., or equivalent). Use 80 milliliters for the test. If
necessary, benzene may be purified by distillation or otherwise.
Hexane, spectro grade (Burdick and Jackson Laboratories, Inc.,
Muskegon, Mich., or equivalent). Use 650 milliliters for the test. If
necessary, hexane may be purified by distillation or otherwise.
1,2-Dichloroethane, spectro grade (Matheson, Coleman, and Bell, East
Rutherford, N.J., or equivalent). Use 20 milliliters for test. If
necessary, 1,2-dichloroethane may be purified by distillation.
Eluting mixtures:
1. 10 percent 1,2-dichloroethane in hexane. Pipet 100 milliliters of
1,2-dichloroethane into a 1-liter glass-stoppered volumetric flask and
adjust to volume with hexane, with mixing.
2. 40 percent benzene in hexane. Pipet 400 milliliters of benzene
into a 1-liter glass-stoppered volumetric flask and adjust to volume
with hexane, with mixing.
n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 5 milliliters with isooctane and determine the absorbance
in a 1-centimeter cell compared to isooctane as reference between 280
m[mu]-400m[mu]. The absorbance per centimeter path length shall not
exceed 0.00 in this range. If necessary, n-hexadecane may be purified by
percolation through activated silica gel or by distillation.
Silica gel, 28-200 mesh (Grade 12, Davison Chemical Co., Baltimore,
Md., or equivalent). Activate as follows: Weigh about 900 grams into a
1-gallon bottle, add 100 milliliters of de-ionized water, seal the
bottle and shake and roll at intervals for 1 hour. Allow to equilibrate
overnight in the sealed bottle. Activate the gel at 150 deg.C for 16
hours, in a 2-inch x 7-inch x 12-inch porcelain pan loosely covered with
aluminum foil, cool in a dessicator, transfer to a bottle and seal.
Procedure
Determination of ultraviolet absorbance. Before proceeding with the
analysis of a sample determine the absorbance in a 1-centimeter path
cell for the reagent blank by carrying out the procedure without a
sample. Record the absorbance in the wavelength range of 280 to 400
millimicrons. Typical reagent blank absorbance in this range should not
exceed 0.04 in the 280 to 299 millimicron range, 0.02 in the 300 to 359
millimicron range, and 0.01 in the 360 to 400 millimicron range. If the
characteristic benzene peaks in the 250 to 260 millimicron region are
present, remove the benzene by the procedure described above under
"Reagents and Materials," "Organic Solvents," and record absorbance
again.
Transfer 50 grams of silica gel to the chromatographic tube for
sample analysis. Raise and drop the column on a semisoft, clean surface
for about 1 minute to settle the gel. Pour 100 milliliters of hexane
into the column with the stopcock open and allow to drain to about one-
half inch above the gel. Turn off the stopcock and allow the column to
cool for 30 minutes. After cooling, vibrate the column to eliminate air
and stir the top 1 to 2 inches with a small diameter stainless steel
rod. Take care not to get the gel above the liquid and onto the sides of
the column.
Weigh out 40 grams 0.1 gram of the hydrocarbon solvent
sample into a 250-milliliter beaker, add 50 milliliters of hexane, and
pour the solution into the column. Rinse the beaker with 50 milliliters
of hexane and add this to the column. Allow the hexane sample solution
to elute into a 500-milliliter beaker until the solution is about one-
half inch above the gel. Rinse the column three times with 50-milliliter
portions of hexane. Allow each hexane rinse to separately elute to about
one-half inch above the gel. Replace the eluate beaker (discard the
hexane eluate) with a 250-milliliter beaker. Add two separate 25-
milliliter portions of 10 percent 1,2-dichloroethane and allow each to
separately elute as before. Finally, add 150 milliliters of 10 percent
1,2-dichloroethane for a total of 200 milliliters. When the final 10
percent 1,2-dichloroethane fraction is about one-half inch above the top
of the gel bed, replace the
[[Page 101]]
receiving beaker (discard the 1,2-dichloroethane eluate) with a 250-
milliliter beaker containing 1 milliliter of hexadecane. Adjust the
elution rate to 2 to 3 milliliters per minute, add two 25-milliliter
portions of 40 percent benzene and allow each to separately elute as
before to within about one-half inch of the gel bed. Finally, add 150
milliliters of 40 percent benzene for a total of 200 milliliters.
Evaporate the benzene in the oven with vacuum and sufficient nitrogen
flow to just ripple the top of the benzene solution. When the benzene is
removed (as determined by a constant volume of hexadecane) add 5
milliliters of isooctane and evaporate. Repeat once to insure complete
removal of benzene. Remove the beaker and cover with aluminum foil
(previously rinsed with hexane) until cool.
Quantitatively transfer the hexadecane residue to a 5-milliliter
volumetric flask and dilute to volume with isooctane. Determine the
absorbance of the solution in 1-centimeter path length cells between 280
and 400 millimicrons using isooctane as a reference. Correct the
absorbance values for any absorbance derived from reagents as determined
by carrying out the procedure without a sample. If the corrected
absorbance does not exceed the limits prescribed in paragraph (b)(1)(ii)
of this section, the sample meets the ultraviolet absorbance
specifications for hydrocarbon solvent.
(c) Synthetic fatty alcohols may be used as follows:
(1) As substitutes for the corresponding naturally derived fatty
alcohols permitted in food by existing regulations in this part or part
173 of this chapter provided that the use is in compliance with any
prescribed limitations.
(2) As substitutes for the corresponding naturally derived fatty
alcohols used as intermediates in the synthesis of food additives and
other substances permitted in food.
[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11837, Mar. 19, 1982;
49 FR 10105, Mar. 19, 1984; 54 FR 24897, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.866]
[Page 101]
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. 172.866 Synthetic glycerin produced by the hydrogenolysis of carbohydrates.
Synthetic glycerin produced by the hydrogenolysis of carbohydrates
may be safely used in food, subject to the provisions of this section:
(a) It shall contain not in excess of 0.2 percent by weight of a
mixture of butanetriols.
(b) It is used or intended for use in an amount not to exceed that
reasonably required to produce its intended effect.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.867]
[Page 101-104]
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 following specifications:
(1) The total content of octa-, hepta-, and hexa-esters is not less
than 97 percent as determined by a method entitled "Determination of
Olestra by Size Exclusion Chromatography," dated December 19, 1995,
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. Copies are available from the Office of Premarket
Approval, Center for Food Safety and Applied Nutrition (HFS-200), Food
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, or may be examined at the Center for Food Safety and Applied
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or
at the Office of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC.
(2) The content of octa-ester is not less than 70 percent as
determined by a method entitled "Measurement of the Relative Ester
Distribution of Olestra Test Material" dated December 19, 1995, which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Copies are available from the Office of Premarket Approval,
Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may
be examined at the Center for Food Safety and Applied Nutrition's
Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC.
(3) The content of hexa-ester is not more than 1 percent as
determined by
[[Page 102]]
the method listed in paragraph (b)(2) of this section.
(4) The content of penta-ester is not more than 0.5 percent as
determined by the method listed in paragraph (b)(2) of this section.
(5) The unsaturated fatty acid content is not less than 25 percent
(thus not more than 75 percent saturated fatty acid) and not more than
83 percent as determined by a method entitled "Measurement of the Fatty
Acid Composition of Olestra Test Material," dated December 19, 1995,
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. Copies are available from the Office of Premarket
Approval, Center for Food Safety and Applied Nutrition (HFS-200), Food
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, or may be examined at the Center for Food Safety and Applied
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or
at the Office of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC.
(6) The content of C12 and C14 fatty acids is each not more than 1
percent, and total C20 and longer fatty acids is not more than 20
percent. C16 and C18 fatty acids make up the remainder with total
content not less than 78 percent as determined by the method listed in
paragraph (b)(5) of this section.
(7) The free fatty acid content is not more than 0.5 percent as
determined by a method entitled "Free Fatty Acids" published in the
Official Methods and Recommended Practices of the American Oil Chemists'
Society, 3d Ed. (1985) vol. 1, which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available
from the American Oil Chemists Society, 1608 Broadmoor Dr., Champaign,
IL 61821, or may be examined at the Center for Food Safety and Applied
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or
at the Office of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC.
(8) The residue on ignition (sulfated ash) is not more than 0.5
percent.
(9) Total methanol content is not more than 300 parts per million as
determined by the "Total Available Methanol Method," dated December
19, 1995, which is incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies are available from the Office of
Premarket Approval, Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740 or may be examined at the Center for Food Safety and
Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD
20740, or at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC.
(10) The total heavy metal content (as Pb) is not more than 10 parts
per million.
(11) Lead is not more than 0.1 part per million, as determined by a
method entitled "Atomic Absorption Spectrophotometric Graphite Furnace
Method," Food Chemicals Codex, 3d Ed. 3d Supp. p. 168 (1992), which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the National Research Council Press,
2101 Constitution Ave. NW., Washington, DC, or may be examined at the
Center for Food Safety and Applied Nutrition's Library, 5100 Paint
Branch Pkwy., College Park, MD 20740, or at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
(12) Water is not more than 0.1 percent, as determined by a method
entitled "Moisture," Official Methods and Recommended Practices of the
American Oil Chemists' Society, 4th Ed. (1989), vol. 1, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the American Oil Chemists Society,
1608 Broadmoor Dr., Champaign, IL 61821, or may be examined at the
Center for Food Safety and Applied Nutrition's Library, 5100 Paint
Branch Pkwy., College Park, MD 20740, or at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
(13) Peroxide value is not more than 10 meq/kg as determined by a
method entitled "Peroxide Value," Official Methods and Recommended
Practices of the American Oil Chemists' Society, 4th Ed. (1989) vol. 1,
which is incorporated by reference in accordance with 5
[[Page 103]]
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the American
Oil Chemists Society, 1608 Broadmoor Dr., Champaign, IL 61821, or may be
examined at the Center for Food Safety and Applied Nutrition's Library,
5100 Paint Branch Pkwy., College Park, MD 20740, or at the Office of the
Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
DC.
(14) The stiffness is not less than 50 kiloPascals/second, as
determined by a method entitled "Method for Measurement of the
Stiffness of Olestra," dated December 19, 1995, which is incorporated
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
Copies are available from the Office of Premarket Approval, Center for
Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may
be examined at the Center for Food Safety and Applied Nutrition's
Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the
Office of the Federal Register, 800 North Capitol St. NW., suite 700,
Washington, DC.
(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. 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 [mu]g
vitamin K1 per gram olestra.
(e)(1) The label of a food containing olestra shall bear the
following statement in the manner prescribed in paragraph (e)(2) of this
section:
This Product Contains Olestra. Olestra may cause abdominal cramping
and loose stools. Olestra inhibits the absorption of some vitamins and
other nutrients. Vitamins A, D, E, and K have been added.
(2) The statement required by paragraph (e)(1) of this section
shall:
(i) Appear either on the principal display panel or on the
information panel of the label;
(ii) Be enclosed by a 0.5 point box rule with 2.5 points of space
around the statement.
(iii) Utilize at least one point leading;
(iv) Have type that is kerned so the letters do not touch;
(v) Be all black or one color type, printed on a white or other
neutral contrasting background whenever possible;
(vi) Utilize a single easy-to-read type style such as Helvetica
Regular and upper and lower case letters; and
(vii) Be in type size no smaller than 8 point.
(3) The sentence "This Product Contains Olestra." shall be
highlighted by bold or extra bold type, such as Helvetica Black. The
label shall appear as follows:
[GRAPHIC] [TIFF OMITTED] TR30JA96.001
[[Page 104]]
(4) 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.
(5) Olestra shall not be considered as a source of fat or calories
for purposes of Secs. 101.9 and 101.13 of this chapter.
(f) Consistent with its obligation to monitor the safety of all
additives in the food supply, including olestra, the Food and Drug
Administration will review and evaluate all data and information bearing
on the safety of olestra received by the agency after the effective date
of this regulation, and will present such data, information, and
evaluation to the agency's Food Advisory Committee within 30 months of
the effective date of this regulation. The purpose of such presentation
will be to receive advice from the Committee on whether there continues
to be reasonable certainty that use of olestra in compliance with this
regulation is not harmful. The agency will hold such additional Food
Advisory Committee meetings on olestra as the agency determines, in its
discretion, to be necessary. Based upon the results of this entire
process, the FDA will initiate any appropriate regulatory proceedings.
[61 FR 3171, Jan. 30, 1996; 61 FR 11546, Mar. 21, 1996]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.868]
[Page 104]
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. 172.868 Ethyl cellulose.
The food additive ethyl cellulose may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive is a cellulose ether containing ethoxy
(OC2H5) groups attached by an ether linkage and
containing on an anhydrous basis not more than 2.6 ethoxy groups per
anhydroglucose unit.
(b) It is used or intended for use as follows:
(1) As a binder and filler in dry vitamin preparations.
(2) As a component of protective coatings for vitamin and mineral
tablets.
(3) As a fixative in flavoring compounds.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.870]
[Page 104]
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. 172.870 Hydroxypropyl cellulose.
The food additive hydroxypropyl cellulose may be safely used in
food, except standardized foods that do not provide for such use, in
accordance with the following prescribed conditions:
(a) The additive consists of one of the following:
(1) A cellulose ether containing propylene glycol groups attached by
an ether linkage which contains, on an anhydrous basis, not more than
4.6 hydroxypropyl groups per anhydroglucose unit. The additive has a
minimum viscosity of 145 centipoises for 10 percent by weight aqueous
solution at 25 deg.C.
(2) A cellulose ether containing propylene glycol groups attached by
an ether linkage having a hydroxypropoxy (OC3H6OH)
content of 5 to 16 percent weight in weight (w/w) on an anhydrous basis,
i.e., 0.1 to 0.4 hydroxypropyl groups per anhydroglucose unit. The
common name for this form of the additive is low substituted
hydroxypropyl cellulose.
(b) The additive is used or intended for use as follows:
(1) The additive identified in paragraph (a)(1) of this section is
used or intended for use as an emulsifier, film former, protective
colloid, stabilizer, suspending agent, or thickener, in accordance with
good manufacturing practice.
(2) The additive identified in paragraph (a)(2) of this section is
used or intended for use as a binder and disintegrator in tablets or
wafers containing dietary supplements of vitamins and/or minerals. The
additive is used in accordance with good manufacturing practice.
[46 FR 50065, Oct. 9, 1981]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.872]
[Page 104-105]
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. 172.872 Methyl ethyl cellulose.
The food additive methyl ethyl cellulose may be safely used in food
in accordance with the following prescribed conditions.
(a) The additive is a cellulose ether having the general formula
[C6H(10-x-
y)O5(CH3)x(C2H5
)y]n, where x is the number of methyl groups and y
is the number of ethyl groups. The average value
[[Page 105]]
of x is 0.3 and the average value of y is 0.7.
(b) The additive meets the following specifications:
(1) The methoxy content shall be not less than 3.5 percent and not
more than 6.5 percent, calculated as OCH3, and the ethoxy
content shall be not less than 14.5 percent and not more than 19
percent, calculated as OC2H5, both measured on the
dry sample.
(2) The viscosity of an aqueous solution, 2.5 grams of the material
in 100 milliliters of water, at 20 deg.C, is 20 to 60 centipoises.
(3) The ash content on a dry basis has a maximum of 0.6 percent.
(c) The food additive is used as an aerating, emulsifying, and
foaming agent, in an amount not in excess of that reasonably required to
produce its intended effect.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.874]
[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. 172.874 Hydroxypropyl methylcellulose.
The food additive hydroxypropyl methylcellulose (CAS Reg. No. 9004-
65-3) may be safely used in food, except in standardized foods which do
not provide for such use if:
(a) The additive complies with the definition and specifications
prescribed in the National Formulary, 12th edition.
(b) It is used or intended for use as an emulsifier, film former,
protective colloid, stabilizer, suspending agent, or thickener, in
accordance with good manufacturing practice.
(c) To insure safe use of the additive, the container of the
additive, in addition to being labeled as required by the general
provisions of the act, shall be accompanied by labeling which contains
adequate directions for use to provide a final product that complies
with the limitations prescribed in paragraph (b) of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 38273, Aug. 31, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.876]
[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. 172.876 Castor oil.
The food additive castor oil may be safely used in accordance with
the following conditions:
(a) The additive meets the specifications of the United States
Pharmacopeia XX (1980).
(b) The additive is used or intended for use as follows:
Use and Limitations
Hard candy production--As a release agent and antisticking agent,
not to exceed 500 parts per million in hard candy.
Vitamin and mineral tablets--As a component of protective coatings.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.878]
[Page 105-106]
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. 172.878 White mineral oil.
White mineral oil may be safely used in food in accordance with the
following conditions:
(a) White mineral oil is a mixture of liquid hydrocarbons,
essentially paraffinic and naphthenic in nature obtained from petroleum.
It is refined to meet the following specifications:
(1) It meets the test requirements of the United States Pharmacopeia
XX (1980) for readily carbonizable substances (page 532).
(2) It meets the test requirements of U.S.P. XVII for sulfur
compounds (page 400).
(3) It meets the specifications prescribed in the "Journal of the
Association of Official Analytical Chemists," Volume 45, page 66
(1962), which is incorporated by reference, after correction of the
ultraviolet absorbance for any absorbance due to added antioxidants.
Copies of the material incorporated by reference are available from the
Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408.
(b) White mineral oil may contain any antioxidant permitted in food
by regulations issued in accordance with section 409 of the Act, in an
amount not greater than that required to produce its intended effect.
(c) White mineral oil is used or intended for use as follows:
[[Page 106]]
------------------------------------------------------------------------
Limitation (inclusive of
all petroleum hydrocarbons
Use that may be used in
combination with white
mineral oil)
------------------------------------------------------------------------
1. As a release agent, binder, and lubricant Not to exceed 0.6% of the
in or on capsules and tablets containing capsule or tablet.
concentrates of flavoring, spices,
condiments, and nutrients intended for
addition to food, excluding confectionery.
2. As a release agent, binder, and lubricant Not to exceed 0.6% of the
in or on capsules and tablets containing capsule or tablet.
food for special dietary use.
3. As a float on fermentation fluids in the In an amount not to exceed
manufacture of vinegar and wine to prevent good manufacturing
or retard access of air, evaporation, and practice.
wild yeast contamination during
fermentation.
4. As a defoamer in food.................... In accordance with Sec.
173.340 of this chapter.
5. In bakery products, as a release agent Not to exceed 0.15% of
and lubricant. bakery products.
6. In dehydrated fruits and vegetables, as a Not to exceed 0.02% of
release agent. dehydrated fruits and
vegetables.
7. In egg white solids, as a release agent.. Not to exceed 0.1% of egg
white solids.
8. On raw fruits and vegetables, as a In an amount not to exceed
protective coating. good manufacturing
practice.
9. In frozen meat, as a component of hot- Not to exceed 0.095% of
melt coating. meat.
10. As a protective float on brine used in In an amount not to exceed
the curing of pickles. good manufacturing
practice.
11. In molding starch used in the Not to exceed 0.3 percent
manufacture of confectionery. in the molding starch.
12. As a release agent, binder, and Not to exceed 0.15 percent
lubricant in the manufacture of yeast. of yeast.
13. As an antidusting agent in sorbic acid Not to exceed 0.25 percent
for food use. in the sorbic acid.
14. As release agent and as sealing and Not to exceed 0.2 percent
polishing agent in the manufacture of of confectionery.
confectionery.
15. As a dust control agent for wheat, corn, Applied at a level of no
soybean, barley, rice, rye, oats, and more than 0.02 percent by
sorghum. weight of grain.
16. As a dust control agent for rice........ ISO 100 oil viscosity (100
centistokes (cSt) at 100
deg.F) applied at a level
of no more than 0.08
percent by weight of the
rice grain.
------------------------------------------------------------------------
[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 8764, Mar. 2, 1982; 47
FR 11838, Mar. 19, 1982; 48 FR 55728, Dec. 15, 1983; 49 FR 10105, Mar.
19, 1984; 54 FR 24897, June 12, 1989; 63 FR 66014, Dec. 1, 1998]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.880]
[Page 106-107]
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. 172.880 Petrolatum.
Petrolatum may be safely used in food, subject to the provisions of
this section.
(a) Petrolatum complies with the specifications set forth in the
United States Pharmacopeia XX (1980) for white petrolatum or in the
National Formulary XV (1980) for petrolatum.
(b) Petrolatum meets the following ultraviolet absorbance limits
when subjected to the analytical procedure described in Sec. 172.886(b):
Ultraviolet absorbance per centimeter path length:
------------------------------------------------------------------------
Millimicrons Maximum
------------------------------------------------------------------------
280-289..................................................... 0.25
290-299..................................................... .20
300-359..................................................... .14
360-400..................................................... .04
------------------------------------------------------------------------
(c) Petrolatum is used or intended for use as follows:
------------------------------------------------------------------------
Limitation (inclusive of all
petroleum hydrocarbons that may
Use be used in combination with
petrolatum)
------------------------------------------------------------------------
In bakery products; as release agent With white mineral oil, not to
and lubricant. exceed 0.15 percent of bakery
product.
In confectionery; as release agent and Not to exceed 0.2 percent of
as sealing and polishing agent. confectionery.
In dehydrated fruits and vegetables; as Not to exceed 0.02 percent of
release agent. dehydrated fruits and
vegetables.
In egg white solids; as release agent.. Not to exceed 0.1 percent of
egg white solids.
On raw fruits and vegetables; as In an amount not to exceed good
protective coating. manufacturing practice.
In beet sugar and yeast; as defoaming As prescribed in Sec. 173.340
agent. of this chapter.
------------------------------------------------------------------------
[[Page 107]]
(d) Petrolatum may contain any antioxidant permitted in food by
regulations issued in accordance with section 409 of the Act, in an
amount not greater than that required to produce its intended effect.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.882]
[Page 107]
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. 172.882 Synthetic isoparaffinic petroleum hydrocarbons.
Synthetic isoparaffinic petroleum hydrocarbons may be safely used in
food, in accordance with the following conditions:
(a) They are produced by synthesis from petroleum gases and consist
of a mixture of liquid hydrocarbons meeting the following
specifications:
Boiling point 93-260 deg.C as determined by ASTM method D86-82,
"Standard Method for Distillation of Petroleum Products," which is
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
Ultraviolet absorbance:
260-319 millimicrons--1.5 maximum.
320-329 millimicrons--0.08 maximum.
330-350 millimicrons--0.05 maximum.
Nonvolatile residual: 0.002 gram per 100 milliliters maximum.
Synthetic isoparaffinic petroleum hydrocarbons containing
antioxidants shall meet the specified ultraviolet absorbance limits
after correction for any absorbance due to the antioxidants. The
ultraviolet absorbance shall be determined by the procedure described
for application of mineral oil, disregarding the last sentence of the
procedure, under "Specifications" on page 66 of the "Journal of the
Association of Official Analytical Chemists," Volume 45 (February
1962), which is incorporated by reference. Copies are available from the
Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408. For
hydrocarbons boiling below 250 deg.F, the nonvolatile residue shall be
determined by ASTM method D1353-78, "Standard Test Method for
Nonvolatile Matter in Volatile Solvents for Use in Paint, Varnish,
Lacquer, and Related Products;" for those boiling above 121 deg.C,
ASTM method D381-80, "Standard Test Method for Existent Gum in Fuels by
Jet Evaporation" shall be used. These methods are incorporated by
reference. Copies may be obtained from the American Society for Testing
Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at
the Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(b) Isoparaffinic petroleum hydrocarbons may contain antioxidants
authorized for use in food in an amount not to exceed that reasonably
required to accomplish the intended technical effect nor to exceed any
prescribed limitations.
(c) Synthetic isoparaffinic petroleum hydrocarbons are used or
intended for use as follows:
------------------------------------------------------------------------
Uses Limitations
------------------------------------------------------------------------
1. In the froth-flotation cleaning of In an amount not to exceed
vegetables. good manufacturing
practice.
2. As a component of insecticide Do.
formulations for use on processed foods.
3. As a component of coatings on fruits Do.
and vegetables.
4. As a coating on shell eggs............. Do.
5. As a float on fermentation fluids in Do.
the manufacture of vinegar and wine and
on brine used in curing pickles, to
prevent or retard access of air,
evaporation, and contamination with wild
organisms during fermentation.
------------------------------------------------------------------------
[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19, 1982;
49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.884]
[Page 107-108]
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. 172.884 Odorless light petroleum hydrocarbons.
Odorless light petroleum hydrocarbons may be safely used in food, in
accordance with the following prescribed conditions:
(a) The additive is a mixture of liquid hydrocarbons derived from
petroleum or synthesized from petroleum gases. The additive is chiefly
paraffinic, isoparaffinic, or naphthenic in nature.
(b) The additive meets the following specifications:
(1) Odor is faint and not kerosenic.
(2) Initial boiling point is 300 deg.F minimum.
(3) Final boiling point is 650 deg.F maximum.
(4) Ultraviolet absorbance limits determined by method specified in
Sec. 178.3620(b)(1)(ii) of this chapter, as follows:
[[Page 108]]
------------------------------------------------------------------------
Maximum
absorbance
per
Wavelength m[mu] centimeter
optical
pathlength
------------------------------------------------------------------------
280-289..................................................... 4.0
290-299..................................................... 3.3
300-329..................................................... 2.3
330-360..................................................... .8
------------------------------------------------------------------------
(c) The additive is used as follows:
------------------------------------------------------------------------
Use Limitations
------------------------------------------------------------------------
As a coating on shell eggs................ In an amount not to exceed
good manufacturing
practice.
As a defoamer in processing beet sugar and Complying with Sec. 173.340
yeast. of this chapter.
As a float on fermentation fluids in the In an amount not to exceed
manufacture of vinegar and wine to good manufacturing
prevent or retard access of air, practice.
evaporation, and wild yeast contamination
during fermentation.
In the froth-flotation cleaning of Do.
vegetables.
As a component of insecticide formulations Do.
used in compliance with regulations
issued in parts 170 through 189 of this
chapter.
------------------------------------------------------------------------
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.886]
[Page 108-113]
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. 172.886 Petroleum wax.
Petroleum wax may be safely used in or on food, in accordance with
the following conditions:
(a) Petroleum wax is a mixture of solid hydrocarbons, paraffinic in
nature, derived from petroleum, and refined to meet the specifications
prescribed by this section.
(b) Petroleum wax meets the following ultraviolet absorbance limits
when subjected to the analytical procedure described in this paragraph.
------------------------------------------------------------------------
Maximum
ultraviolet
absorbance
per
centimeter
path length
------------------------------------------------------------------------
280-289 millimicrons....................................... 0.15
290-299 millimicrons....................................... 0.12
300-359 millimicrons....................................... 0.08
360-400 millimicrons....................................... 0.02
------------------------------------------------------------------------
Analytical Specification for Petroleum Wax
general instructions
Because of the sensitivity of the test, the possibility of errors
arising from contamination is great. It is of the greatest importance
that all glassware be scrupulously cleaned to remove all organic matter
such as oil, grease, detergent residues, etc. Examine all glassware,
including stoppers and stopcocks, under ultraviolet light to detect any
residual fluorescent contamination. As a precautionary measure it is
recommended practice to rinse all glassware with purified isooctane
immediately before use. No grease is to be used on stopcocks or joints.
Great care to avoid contamination of wax samples in handling and to
assure absence of any extraneous material arising from inadequate
packaging is essential. Because some of the polynuclear hydrocarbons
sought in this test are very susceptible to photo-oxidation, the entire
procedure is to be carried out under subdued light.
apparatus
Separatory funnels. 250-milliliter, 500-milliliter, 1,000-
milliliter, and preferably 2,000-milliliter capacity, equipped with
tetrafluoroethylene polymer stopcocks.
Reservoir. 500-milliliter capacity, equipped with a 24/40 standard
taper male fitting at the bottom and a suitable ball-joint at the top
for connecting to the nitrogen supply. The male fitting should be
equipped with glass hooks.
Chromatographic tube. 180 millimeters in length, inside diameter to
be 15.7 millimeters 0.1 millimeter, equipped with a coarse,
fritted-glass disc, a tetrafluoroethylene polymer stopcock, and a female
24/40 standard tapered fitting at the opposite end. (Overall length of
the column with the female joint is 235 millimeters.) The female fitting
should be equipped with glass hooks.
Disc. Tetrafluoroethylene polymer 2-inch diameter disc approximately
\3/16\-inch thick with a hole bored in the center to closely fit the
stem of the chromatographic tube.
Heating jacket. Conical, for 500-milliliter separatory funnel. (Used
with variable transformer heat control.)
Suction flask. 250-milliliter or 500-milliliter filter flask.
Condenser. 24/40 joints, fitted with a drying tube, length optional.
Evaporation flask (optional). 250-milliliter or 500-milliliter
capacity all-glass flask equipped with standard taper stopper having
inlet and outlet tubes to permit passage of nitrogen across the surface
of contained liquid to be evaporated.
Vacuum distillation assembly. All glass (for purification of
dimethyl sulfoxide); 2-liter distillation flask with heating mantle;
Vigreaux vacuum-jacketed condenser (or equivalent) about 45 centimeters
in length and distilling head with separable cold finger condenser. Use
of tetrafluoroethylene polymer sleeves on the glass joints will prevent
freezing. Do not use grease on stopcocks or joints.
Spectrophotometric cells. Fused quartz cells, optical path length in
the range of 5.000 centimeters 0.005 centimeter; also for
checking
[[Page 109]]
spectrophotometer performance only, optical path length in the range
1.000 centimeter 0.005 centimeter. With distilled water in
the cells, determine any absorbance differences.
Spectrophotometer. Spectral range 250 millimicrons-400 millimicrons
with spectral slit width of 2 millimicrons or less, under instrument
operating conditions for these absorbance measurements, the
spectrophotometer shall also meet the following performance
requirements:
Absorbance repeatability, 0.01 at 0.4 absorbance.
Absorbance accuracy, \1\ 0.05 at 0.4 absorbance.
---------------------------------------------------------------------------
\1\ As determined by using potassium chromate for reference standard
and described in National Bureau of Standards Circular 484,
Spectrophotometry, U.S. Department of Commerce, (1949). The accuracy is
to be determined by comparison with the standard values at 290, 345, and
400 millimicrons. Circular 484 is incorporated by reference. Copies are
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
---------------------------------------------------------------------------
Wavelength repeatability, 0.2 millimicron.
Wavelength accuracy, 1.0 millimicron.
Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in
cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.
reagents and materials
Organic solvents. All solvents used throughout the procedure shall
meet the specifications and tests described in this specification. The
isooctane, benzene, acetone, and methyl alcohol designated in the list
following this paragraph shall pass the following test:
To the specified quantity of solvent in a 250-milliliter Erlenmeyer
flask, add 1 milliliter of purified n-hexadecane and evaporate on the
steam bath under a stream of nitrogen (a) loose aluminum foil jacket
around the flask will speed evaporation). Discontinue evaporation when
not over 1 milliliter of residue remains. (To the residue from benzene
add a 10-milliliter portion of purified isooctane, reevaporate, and
repeat once to insure complete removal of benzene.)
Alternatively, the evaporation time can be reduced by using the
optional evaporation flask. In this case the solvent and n-hexadecane
are placed in the flask on the steam bath, the tube assembly is
inserted, and a stream of nitrogen is fed through the inlet tube while
the outlet tube is connected to a solvent trap and vacuum line in such a
way as to prevent any flow-back of condensate into the flask.
Dissolve the 1 milliliter of hexadecane residue in isooctane and
make to 25 milliliters volume. Determine the absorbance in the 5-
centimeter path length cells compared to isooctane as reference. The
absorbance of the solution of the solvent residue (except for methyl
alcohol) shall not exceed 0.01 per centimeter path length between 280
and 400 m[mu]. For methyl alcohol this absorbance value shall be 0.00.
Isooctane (2,2,4-trimethylpentane). Use 180 milliliters for the test
described in the preceding paragraph. Purify, if necessary, by passage
through a column of activated silica gel (Grade 12, Davison Chemical
Company, Baltimore, Maryland, or equivalent) about 90 centimeters in
length and 5 centimeters to 8 centimeters in diameter.
Benzene, A.C.S. reagent grade. Use 150 milliliters for the test.
Purify, if necessary, by distillation or otherwise.
Acetone, A.C.S. reagent grade. Use 200 milliliters for the test.
Purify, if necessary, by distillation.
Eluting mixtures:
1. 10 percent benzene in isooctane. Pipet 50 milliliters of benzene
into a 500-milliliter glass-stoppered volumetric flask and adjust to
volume with isooctane, with mixing.
2. 20 percent benzene in isooctane. Pipet 50 milliliters of benzene
into a 250-milliliter glass-stoppered volumetric flask, and adjust to
volume with isooctane, with mixing.
3. Acetone-benzene-water mixture. Add 20 milliliters of water to 380
milliliters of acetone and 200 milliliters of benzene, and mix.
n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 25 milliliters with isooctane and determine the absorbance
in a 5-centimeter cell compared to isooctane as reference point between
280 m[mu]-400 m[mu]. The absorbance per centimeter path length shall not
exceed 0.00 in this range. Purify, if necessary, by percolation through
activated silica gel or by distillation.
Methyl alcohol, A.C.S. reagent grade. Use 10.0 milliliters of methyl
alcohol. Purify, if necessary, by distillation.
Dimethyl sulfoxide. Pure grade, clear, water-white, m.p. 18 deg.
minimum. Dilute 120 milliliters of dimethyl sulfoxide with 240
milliliters of distilled water in a 500-milliliter separatory funnel,
mix and allow to cool for 5-10 minutes. Add 40 milliliters of isooctane
to the solution and extract by shaking the funnel vigorously for 2
minutes. Draw off the lower aqueous layer into a second 500-milliliter
separatory funnel and repeat the extraction with 40 milliliters of
isooctane. Draw off and discard the aqueous layer. Wash each of the 40-
milliliter extractives three times with 50-milliliter portions of
distilled water. Shaking time for each
[[Page 110]]
wash is 1 minute. Discard the aqueous layers. Filter the first
extractive through anhydrous sodium sulfate prewashed with isooctane
(see Sodium sulfate under "Reagents and Materials" for preparation of
filter), into a 250-milliliter Erlenmeyer flask, or optionally into the
evaporating flask. Wash the first separatory funnel with the second 40-
milliliter isooctane extractive, and pass through the sodium sulfate
into the flask. Then wash the second and first separatory funnels
successively with a 10-milliliter portion of isooctane, and pass the
solvent through the sodium sulfate into the flask. Add 1 milliliter of
n-hexadecane and evaporate the isooctane on the steam bath under
nitrogen. Discontinue evaporation when not over 1 milliliter of residue
remains. To the residue, add a 10-milliliter portion of isooctane and
reevaporate to 1 milliliter of hexadecane. Again, add 10 milliliters of
isooctane to the residue and evaporate to 1 milliliter of hexadecane to
insure complete removal of all volatile materials. Dissolve the 1
milliliter of hexadecane in isooctane and make to 25-milliliter volume.
Determine the reference. The absorbance of the solution should not
exceed 0.02 per centimeter path length in the 280 m[mu]-400 m[mu] range.
(Note.--Difficulty in meeting this absorbance specification may be due
to organic impurities in the distilled water. Repetition of the test
omitting the dimethyl sulfoxide will disclose their presence. If
necessary to meet the specification, purify the water by redistillation,
passage through an ion-exchange resin, or otherwise.)
Purify, if necessary, by the following procedure: To 1,500
milliliters of dimethyl sulfoxide in a 2-liter glass-stoppered flask,
add 6.0 milliliters of phosphoric acid and 50 grams of Norit A
(decolorizing carbon, alkaline) or equivalent. Stopper the flask, and
with the use of a magnetic stirrer (tetrafluoroethylene polymer coated
bar) stir the solvent for 15 minutes. Filter the dimethyl sulfoxide
through four thicknesses of fluted paper (18.5 centimeters, Schleicher &
Schuell, No. 597, or equivalent). If the initial filtrate contains
carbon fines, refilter through the same filter until a clear filtrate is
obtained. Protect the sulfoxide from air and moisture during this
operation by covering the solvent in the funnel and collection flask
with a layer of isooctane. Transfer the filtrate to a 2-liter separatory
funnel and draw off the dimethyl sulfoxide into the 2-liter distillation
flask of the vacuum distillation assembly and distill at approximately
3-millimeter Hg pressure or less. Discard the first 200-milliliter
fraction of the distillate and replace the distillate collection flask
with a clean one. Continue the distillation until approximately 1 liter
of the sulfoxide has been collected.
At completion of the distillation, the reagent should be stored in
glass-stoppered bottles since it is very hygroscopic and will react with
some metal containers in the presence of air.
Phosphoric acid. 85 percent A.C.S. reagent grade.
Sodium borohydride. 98 percent.
Magnesium oxide (Sea Sorb 43, Food Machinery Company, Westvaco
Division, distributed by chemical supply firms, or equivalent). Place
100 grams of the magnesium oxide in a large beaker, add 700 milliliters
of distilled water to make a thin slurry, and heat on a steam bath for
30 minutes with intermittent stirring. Stir well initially to insure
that all the absorbent is completely wetted. Using a Buchner funnel and
a filter paper (Schleicher & Schuell No. 597, or equivalent) of suitable
diameter, filter with suction. Continue suction until water no longer
drips from the funnel. Transfer the absorbent to a glass trough lined
with aluminum foil (free from rolling oil). Break up the magnesia with a
clean spatula and spread out the absorbent on the aluminum foil in a
layer about 1 centimeter to 2 centimeters thick. Dry for 24 hours at 160
deg.C 1 deg.C. Pulverize the magnesia with mortar and
pestle. Sieve the pulverized absorbent between 60-180 mesh. Use the
magnesia retained on the 180-mesh sieve.
Celite 545. Johns-Manville Company, diatomaceous earth, or
equivalent.
Magnesium oxide-Celite 545 mixture (2+ 1) by weight. Place the
magnesium oxide (60-180 mesh) and the Celite 545 in 2 to 1 proportions,
respectively, by weight in a glass-stoppered flask large enough for
adequate mixing. Shake vigorously for 10 minutes. Transfer the mixture
to a glass trough lined with aluminum foil (free from rolling oil) and
spread it out on a layer about 1 centimeter to 2 centimeters thick.
Reheat the mixture at 160 deg.C 1 deg.C for 2 hours, and
store in a tightly closed flask.
Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in
granular form. For each bottle of sodium sulfate reagent used, establish
as follows the necessary sodium sulfate prewash to provide such filters
required in the method: Place approximately 35 grams of anhydrous sodium
sulfate in a 30-milliliter coarse, fritted-glass funnel or in a 65-
millimeter filter funnel with glass wool plug; wash with successive 15-
milliliter portions of the indicated solvent until a 15-milliliter
portion of the wash shows 0.00 absorbance per centimeter path length
between 280 m[mu] and 400 m[mu] when tested as prescribed under
"Organic solvents." Usually three portions of wash solvent are
sufficient.
Before proceeding with analysis of a sample, determine the
absorbance in a 5-centimeter path cell between 250 m[mu] and 400 m[mu]
for the reagent blank by carrying out the procedure, without a wax
sample, at room temperature, recording the spectra after the extraction
stage and after the complete procedure as prescribed. The absorbance per
[[Page 111]]
centimeter path length following the extraction stage should not exceed
0.040 in the wavelength range from 280 m[mu] to 400 m[mu]; the
absorbance per centimeter path length following the complete procedure
should not exceed 0.070 in the wavelength range from 280 m[mu] to 299
m[mu], inclusive, nor 0.045 in the wavelength range from 300 m[mu] to
400 m[mu]. If in either spectrum the characteristic benzene peaks in the
250 m[mu]-260 m[mu] region are present, remove the benzene by the
procedure under "Organic solvents" and record absorbance again.
Place 300 milliliters of dimethyl sulfoxide in a 1-liter separatory
funnel and add 75 milliliters of phosphoric acid. Mix the contents of
the funnel and allow to stand for 10 minutes. (The reaction between the
sulfoxide and the acid is exothermic. Release pressure after mixing,
then keep funnel stoppered.) Add 150 milliliters of isooctane and shake
to preequilibrate the solvents. Draw off the individual layers and store
in glass-stoppered flasks.
Place a representative 1-kilogram sample of wax, or if this amount
is not available, the entire sample, in a beaker of a capacity about
three times the volume of the sample and heat with occasional stirring
on a steam bath until the wax is completely melted and homogeneous.
Weigh four 25-gram 0.2 gram portions of the melted wax in
separate 100-milliliter beakers. Reserve three of the portions for later
replicate analyses as necessary. Pour one weighed portion immediately
after remelting (on the steam bath) into a 500-milliliter separatory
funnel containing 100 milliliters of the preequilibrated sulfoxide-
phosphoric acid mixture that has been heated in the heating jacket at a
temperature just high enough to keep the wax melted. (Note: In
preheating the sulfoxide-acid mixture, remove the stopper of the
separatory funnel at intervals to release the pressure.)
Promptly complete the transfer of the sample to the funnel in the
jacket with portions of the preequilibrated isooctane, warming the
beaker, if necessary, and using a total volume of just 50 milliliters of
the solvent. If the wax comes out of solution during these operations,
let the stoppered funnel remain in the jacket until the wax redissolves.
(Remove stopper from the funnel at intervals to release pressure.) When
the wax is in solution, remove the funnel from the jacket and shake it
vigorously for 2 minutes. Set up three 250-milliliter separatory funnels
with each containing 30 milliliters of preequilibrated isooctane. After
separation of the liquid phases, allow to cool until the main portion of
the wax-isooctane solution begins to show a precipitate. Gently swirl
the funnel when precipitation first occurs on the inside surface of the
funnel to accelerate this process. Carefully draw off the lower layer,
filter it slowly through a thin layer of glass wool fitted loosely in a
filter funnel into the first 250-milliliter separatory funnel, and wash
in tandem with the 30-milliliter portions of isooctane contained in the
250-milliliter separatory funnels. Shaking time for each wash is 1
minute. Repeat the extraction operation with two additional portions of
the sulfoxide-acid mixture, replacing the funnel in the jacket after
each extraction to keep the wax in solution and washing each extractive
in tandem through the same three portions of isooctane.
Collect the successive extractives (300 milliliters total) in a
separatory funnel (preferably 2-liter), containing 480 milliliters of
distilled water, mix, and allow to cool for a few minutes after the last
extractive has been added. Add 80 milliliters of isooctane to the
solution and extract by shaking the funnel vigorously for 2 minutes.
Draw off the lower aqueous layer into a second separatory funnel
(preferably 2-liter) and repeat the extraction with 80 milliliters of
isooctane. Draw off and discard the aqueous layer. Wash each of the 80-
milliliter extractives three times with 100-milliliter portions of
distilled water. Shaking time for each wash is 1 minute. Discard the
aqueous layers. Filter the first extractive through anhydrous sodium
sulfate prewashed with isooctane (see Sodium Sulfate under "Reagents
and Materials" for preparation of filter) into a 250-milliliter
Erlenmeyer flask (or optionally into the evaporation flask). Wash the
first separatory funnel with the second 80-milliliter isooctane
extractive and pass through the sodium sulfate. Then wash the second and
first separatory funnels successively with a 20-milliliter portion of
isooctane and pass the solvent through the sodium sulfate into the
flask. Add 1 milliliter of n-hexadecane and evaporate the isooctane on
the steam bath under nitrogen. Discontinue evaporation when not over 1
milliliter of residue remains. To the residue, add a 10-milliliter
portion of isooctane, reevaporate to 1 milliliter of hexadecane, and
repeat this operation once.
Quantitatively transfer the residue with isooctane to a 25-
milliliter volumetric flask, make to volume, and mix. Determine the
absorbance of the solution in the 5-centimeter path length cells
compared to isooctane as reference between 280 m[mu]-400 m[mu] (take
care to lose none of the solution in filling the sample cell). Correct
the absorbance values for any absorbance derived from reagents as
determined by carrying out the procedure without a wax sample. If the
corrected absorbance does not exceed the limits prescribed in this
paragraph (b), the wax meets the ultraviolet absorbance specifications.
If the corrected absorbance per centimeter path length exceeds the
limits prescribed in this paragraph (b), proceed as follows:
Quantitatively transfer the isooctane solution to a 125-milliliter
flask equipped with
[[Page 112]]
24/40 joint and evaporate the isooctane on the steam bath under a stream
of nitrogen to a volume of 1 milliliter of hexadecane. Add 10
milliliters of methyl alcohol and approximately 0.3 gram of sodium
borohydride. (Minimize exposure of the borohydride to the atmosphere. A
measuring dipper may be used.) Immediately fit a water-cooled condenser
equipped with a 24/40 joint and with a drying tube into the flask, mix
until the borohydride is dissolved, and allow to stand for 30 minutes at
room temperature, with intermittent swirling. At the end of this period,
disconnect the flask and evaporate the methyl alcohol on the steam bath
under nitrogen until the sodium borohydride begins to come out of the
solution. Then add 10 milliliters of isooctane and evaporate to a volume
of about 2-3 milliliters. Again, add 10 milliliters of isooctane and
concentrate to a volume of approximately 5 milliliters. Swirl the flask
repeatedly to assure adequate washing of the sodium borohydride
residues.
Fit the tetrafluoroethylene polymer disc on the upper part of the
stem of the chromatographic tube, then place the tube with the disc on
the suction flask and apply the vacuum (approximately 135 millimeters Hg
pressure). Weight out 14 grams of the 2:1 magnesium oxide-Celite 545
mixture and pour the adsorbent mixture into the chromatographic tube in
approximately 3-centimeter layers. After the addition of each layer,
level off the top of the adsorbent with a flat glass rod or metal
plunger by pressing down firmly until the adsorbent is well packed.
Loosen the topmost few millimeters of each adsorbent layer with the end
of a metal rod before the addition ofthe next layer. Continue packing in
this manner until all the 14 grams of the adsorbent is added to the
tube. Level off the top of the adsorbent by pressing down firmly with a
flat glass rod or metal plunger to make the depth of the adsorbent bed
approximately 12.5 centimeters in depth. Turn off the vacuum and remove
the suction flask. Fit the 500-milliliter reservoir onto the top of the
chromatographic column and prewet the column by passing 100 milliliters
of isooctane through the column. Adjust the nitrogen pressure so that
the rate of descent of the isooctane coming off of the column is between
2-3 milliliters per minute. Discontinue pressure just before the last of
the isooctane reaches the level of the adsorbent. (Caution: Do not allow
the liquid level to recede below the adsorbent level at any time.)
Remove the reservoir and decant the 5-milliliter isooctane concentrate
solution onto the column and with slight pressure again allow the liquid
level to recede to barely above the adsorbent level. Rapidly complete
the transfer similarly with two 5-milliliter portions of isooctane,
swirling the flask repeatedly each time to assure adequate washing of
the residue. Just before the final 5-milliliter wash reaches the top of
the adsorbent, add 100 milliliters of isooctane to the reservoir and
continue the percolation at the 2-3 milliliter per minute rate. Just
before the last of the isooctane reaches the adsorbent level, add 100
milliliters of 10 percent benzene in isooctane to the reservoir and
continue the percolation at the aforementioned rate. Just before the
solvent mixture reaches adsorbent level, add 25 milliliters of 20
percent benzene in isooctane to the reservoir and continue the
percolation at 2-3 milliliters per minute until all this solvent mixture
has been removed from the column. Discard all the elution solvents
collected up to this point. Add 300 milliliters of the acetone-benzene-
water mixture to the reservoir and percolate through the column to elute
the polynuclear compounds. Collect the eluate in a clean 1-liter
separatory funnel. Allow the column to drain until most of the solvent
mixture is removed. Wash the eluate three times with 300-milliliter
portions of distilled water, shaking well for each wash. (The addition
of small amounts of sodium chloride facilitates separation.) Discard the
aqueous layer after each wash. After the final separation, filter the
residual benzene through anhydrous sodium sulfate prewashed with benzene
(see Sodium sulfate under "Reagents and Materials" for preparation of
filter) into a 250-milliliter Erlenmeyer flask (or optionally into the
evaporation flask). Wash the separatory funnel with two additional 20-
milliliter portions of benzene which are also filtered through the
sodium sulfate. Add 1 milliliter of n-hexadecane and completely remove
the benzene by evaporation under nitrogen, using the special procedure
to eliminate benzene as previously described under "Organic Solvents."
Quantitatively transfer the residue with isooctane to a 25-milliliter
volumetric flask and adjust to volume. Determine the absorbance of the
solution in the 5-centimeter path length cells compared to isooctane as
reference between 250 m[mu]-400 m[mu]. Correct for any absorbance
derived from the reagents as determined by carrying out the procedure
without a wax sample. If either spectrum shows the characteristic
benzene peaks in the 250 m[mu]-260 m[mu] region, evaporate the solution
to remove benzene by the procedure under "Organic Solvents." Dissolve
the residue, transfer quantitatively, and adjust to volume in isooctane
in a 25-milliliter volumetric flask. Record the absorbance again. If the
corrected absorbance does not exceed the limits prescribed in this
paragraph (b), the wax meets the ultraviolet absorbance specifications.
(c) Petroleum wax may contain one or more of the following adjuvants
in amounts not greater than that required to produce their intended
effect:
[[Page 113]]
(1) Antioxidants permitted in food by regulations issued in
accordance with section 409 of the act.
(2) Poly(alkylacrylate) (CAS Reg. No. 27029-57-8), made from long
chain (C16-C22) alcohols and acrylic acid, or
poly(alkylmethacrylate) (CAS Reg. No. 179529-36-3), made from long chain
(C18-C22) methacrylate esters, having:
(i) A number average molecular weight between 40,000 and 100,000;
(ii) A weight average molecular weight (MWw) to number
average molecular weight (MWn) ratio (MWw/
MWn) of not less than 3; and
(iii) Unreacted alkylacrylate or alkylmethacrylate monomer content
not in excess of 14 percent, as determined by a method entitled "Method
for Determining Weight-Average and Number-Average Molecular Weight and
for Determining Alkylacrylate Monomer Content of Poly(alkylacrylate)
used as Processing Aid in Manufacture of Petroleum Wax," which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the Office of Premarket Approval
(HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 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 Office of the Federal Register, 800 North
Capitol St. NW., suite 700, Washington, DC. Petroleum wax shall contain
not more than 1,050 parts per million of poly(alkylacrylate) or
poly(alkylmethacrylate) residues as determined by a method entitled
"Method for Determining Residual Level of Poly(alkylacrylate) in
Petroleum Wax," which is incorporated by reference. Copies are
available from the addresses cited in this paragraph.
(d) Petroleum wax is used or intended for use as follows:
------------------------------------------------------------------------
Use Limitations
------------------------------------------------------------------------
In chewing gum base, as a masticatory In an amount not to exceed
substance. good manufacturing
practice.
On cheese and raw fruits and vegetables as Do.
a protective coating.
As a defoamer in food..................... In accordance with Sec.
173.340 of this chapter.
As a component of microcapsules for spice- In accordance with Sec.
flavoring substances. 172.230 of this chapter.
------------------------------------------------------------------------
[42 FR 14491, Mar. 15, 1977, as amended at 45 FR 48123, July 18, 1980;
47 FR 11838, Mar. 19, 1982; 50 FR 32561, Aug. 13, 1985; 51 FR 19544, May
30, 1986; 54 FR 24897, June 12, 1989; 64 FR 44122, Aug. 13, 1999]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.888]
[Page 113]
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. 172.888 Synthetic petroleum wax.
Synthetic petroleum wax may be safely used in or on foods in
accordance with the following conditions:
(a) Synthetic petroleum wax is a mixture of solid hydrocarbons,
paraffinic in nature, prepared by either catalytic polymerization of
ethylene or copolymerization of ethylene with linear (C3 to
C12) alpha-olefins, and refined to meet the specifications
prescribed in this section.
(b) Synthetic petroleum wax meets the ultraviolet absorbance limits
of Sec. 172.886(b) when subjected to the analytical procedure described
therein.
(c) Synthetic petroleum wax has a number average molecular weight of
not less than 500 nor greater than 1,200 as determined by vapor pressure
osmometry.
(d) Synthetic petroleum wax may contain any antioxidant permitted in
food by regulations issued in accordance with section 409 of the act, in
an amount not greater than that required to produce its intended effect.
(e) Synthetic petroleum wax is used or intended for use as follows:
------------------------------------------------------------------------
Use Limitations
------------------------------------------------------------------------
In chewing gum base, as a masticatory In accordance with Sec.
substance. 172.615 in an amount not to
exceed good manufacturing
practice.
On cheese and raw fruits and vegetables as In an amount not to exceed
a protective coating. good manufacturing
practice.
As a defoamer in food..................... In accordance with Sec.
173.340 of this chapter.
------------------------------------------------------------------------
[42 FR 14491, Mar. 15, 1977, as amended at 59 FR 10986, Mar. 9, 1994]
[[Page 114]]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.890]
[Page 114]
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. 172.890 Rice bran wax.
Rice bran wax may be safely used in food in accordance with the
following conditions:
(a) It is the refined wax obtained from rice bran and meets the
following specifications:
Melting point 75 deg.C to 80 deg.C.
Free fatty acids, maximum 10 percent.
Iodine number, maximum 20.
Saponification number 75 to 120.
(b) It is used or intended for use as follows:
------------------------------------------------------------------------
Food Limitation in food Use
------------------------------------------------------------------------
Candy........................... 50 p.p.m.......... Coating.
Fresh fruits and fresh ......do.......... Do.
vegetables.
Chewing gum..................... 2\1/2\ pct........ Plasticizing
material.
------------------------------------------------------------------------
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.892]
[Page 114-115]
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. 172.892 Food starch-modified.
Food starch-modified as described in this section may be safely used
in food. The quantity of any substance employed to effect such
modification shall not exceed the amount reasonably required to
accomplish the intended physical or technical effect, nor exceed any
limitation prescribed. To insure safe use of the food starch-modified,
the label of the food additive container shall bear the name of the
additive "food starch-modified" in addition to other information
required by the Act. Food starch may be modified by treatment prescribed
as follows:
(a) Food starch may be acid-modified by treatment with hydrochloric
acid or sulfuric acid or both.
(b) Food starch may be bleached by treatment with one or more of the
following:
------------------------------------------------------------------------
Limitations
------------------------------------------------------------------------
Active oxygen obtained from hydrogen ............................
peroxide and/or peracetic acid, not to
exceed 0.45 percent of active oxygen.
Ammonium persulfate, not to exceed 0.075 ............................
percent and sulfur dioxide, not to exceed
0.05 percent.
Chlorine, as calcium hypochlorite, not to The finished food starch-
exceed 0.036 percent of dry starch. modified is limited to use
only as a component of
batter for commercially
processed foods.
Chlorine, as sodium hypochlorite, not to ............................
exceed 0.0082 pound of chlorine per pound
of dry starch.
Potassium permanganate, not to exceed 0.2 Residual manganese
percent. (calculated as Mn), not to
exceed 50 parts per million
in food starch-modified.
Sodium chlorite, not to exceed 0.5 percent ............................
------------------------------------------------------------------------
(c) Food starch may be oxidized by treatment with chlorine, as
sodium hypochlorite, not to exceed 0.055 pound of chlorine per pound of
dry starch.
(d) Food starch may be esterified by treatment with one of the
following:
------------------------------------------------------------------------
Limitations
------------------------------------------------------------------------
Acetic anhydride.......................... Acetyl groups in food starch-
modified not to exceed 2.5
percent.
Adipic anhydride, not to exceed 0.12 Do.
percent, and acetic anhydride.
Monosodium orthophosphate................. Residual phosphate in food
starch-modified not to
exceed 0.4 percent
calculated as phosphorus.
1-Octenyl succinic anhydride, not to ............................
exceed 3 percent.
1-Octenyl succinic anhydride, not to ............................
exceed 2 percent, and aluminum sulfate,
not to exceed 2 percent.
1-Octenyl succinic anhydride, not to Limited to use as a
exceed 3 percent, followed by treatment stabilizer or emulsifier in
with a beta-amylase enzyme that is either beverages and beverage
an approved food additive of is generally bases as defined in Sec.
recognized as safe. 170.3(n)(3) of this
chapter.
Phosphorus oxychloride, not to exceed 0.1 ............................
percent.
Phosphorus oxychloride, not to exceed 0.1 Acetyl groups in food starch-
percent, followed by either acetic modified not to exceed 2.5
anhydride, not to exceed 8 percent, or percent.
vinyl acetate, not to exceed 7.5 percent.
Sodium trimetaphosphate................... Residual phosphate in food
starch-modified not to
exceed 0.04 percent,
calculated as phosphorus.
Sodium tripolyphosphate and sodium Residual phosphate in food
trimetaphosphate. starch-modified not to
exceed 0.4 percent
calculated as phosphorus.
Succinic anhydride, not to exceed 4 ............................
percent.
Vinyl acetate............................. Acetyl groups in food starch-
modified not to exceed 2.5
percent.
------------------------------------------------------------------------
(e) Food starch may be etherified by treatment with one of the
following:
------------------------------------------------------------------------
Limitations
------------------------------------------------------------------------
Acrolein, not to exceed 0.6 percent....... ............................
[[Page 115]]
Epichlorohydrin, not to exceed 0.3 percent ............................
Epichlorohydrin, not to exceed 0.1 Residual propylene
percent, and propylene oxide, not to chlorohydrin not more than
exceed 10 percent, added in combination 5 parts per million in food
or in any sequence. starch-modified.
Epichlorohydrin, not to exceed 0.1 Do.
percent, followed by propylene oxide, not
to exceed 25 percent.
Propylene oxide, not to exceed 25 percent. Do.
------------------------------------------------------------------------
(f) Food starch may be esterified and etherified by treatment with
one of the following:
------------------------------------------------------------------------
Limitations
------------------------------------------------------------------------
Acrolein, not to exceed 0.6 percent and Acetyl groups in food starch-
vinyl acetate, not to exceed 7.5 percent. modified not to exceed 2.5
percent.
Epichlorohydrin, not to exceed 0.3 Acetyl groups in food starch-
percent, and acetic anhydride. modified not to exceed 2.5
percent.
Epichlorohydrin, not to exceed 0.3 ............................
percent, and succinic anhydride, not to
exceed 4 percent.
Phosphorus oxychloride, not to exceed 0.1 Residual propylene
percent, and propylene oxide, not to chlorohydrin not more than
exceed 10 percent. 5 parts per million in food
starch-modified.
------------------------------------------------------------------------
(g) Food starch may be modified by treatment with one of the
following:
------------------------------------------------------------------------
Limitations
------------------------------------------------------------------------
Chlorine, as sodium hypochlorite, not to Residual propylene
exceed 0.055 pound of chlorine per pound chlorohydrin not more than
of dry starch; 0.45 percent of active 5 parts per million in food
oxygen obtained from hydrogen peroxide; starch-modified.
and propylene oxide, not to exceed 25
percent.
Sodium hydroxide, not to exceed 1 percent. ............................
------------------------------------------------------------------------
(h) Food starch may be modified by a combination of the treatments
prescribed by paragraphs (a), (b), and/or (i) of this section and any
one of the treatments prescribed by paragraph (c), (d), (e), (f), or (g)
of this section, subject to any limitations prescribed by the paragraphs
named.
(i) Food starch may be modified by treatment with the following
enzymes:
------------------------------------------------------------------------
Enzyme Limitations
------------------------------------------------------------------------
Alpha-amylase (E.C. 3.2.1.1).............. The enzyme must be generally
recognized as safe or
approved as a food additive
for this purpose. The
resulting nonsweet
nutritive saccharide
polymer has a dextrose
equivalent of less than 20.
Beta-amylase (E.C. 3.2.1.2)...............
Glucoamylase (E.C. 3.2.1.3)...............
Isoamylase (E.C. 3.2.1.68)................
Pullulanase (E.C. 3.2.1.41)...............
------------------------------------------------------------------------
[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 11697, Mar. 21, 1978;
46 FR 32015, June 19, 1981; 57 FR 54700, Nov. 20, 1992; 58 FR 21100,
Apr. 19, 1993; 66 FR 17509, Apr. 2, 2001]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.894]
[Page 115-116]
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. 172.894 Modified cottonseed products intended for human consumption.
The food additive modified cottonseed products may be used for human
consumption in accordance with the following prescribed conditions:
(a) The additive is derived from:
(1) Decorticated, partially defatted, cooked, ground cottonseed
kernels; or
(2) Decorticated, ground cottonseed kernels, in a process that
utilizes n-hexane as an extracting solvent in such a way that no more
than 60 parts per million of n-hexane residues and less than 1 percent
fat by weight remain in the finished product; or
(3) Glandless cottonseed kernels roasted to attain a temperature of
not less than 250 deg.F in the kernel for not less than 5 minutes for
use as a snack food, or in baked goods, or in soft candy; or
(4) Raw glandless cottonseed kernels may be used in hard candy where
the kernel temperature during cooking will exceed 250 deg.F for not
less than 5 minutes.
(b) The additive is prepared to meet the following specifications:
(1) Free gossypol content not to exceed 450 parts per million.
(2) It contains no added arsenic compound and therefore may not
exceed a maximum natural background level of 0.2 part per million total
arsenic, calculated as As.
(c) To assure safe use of the additive, the label of the food
additive container shall bear, in addition to other information required
by the act, the name of the additive as follows:
[[Page 116]]
(1) The additive identified in paragraph (a)(1) of this section as
"partially defatted, cooked cottonseed flour".
(2) The additive identified in paragraph (a)(2) of this section as
"defatted cottonseed flour".
(3) The additive identified in paragraph (a)(3) of this section as
"roasted glandless cottonseed kernels".
(4) The additive identified in paragraph (a)(4) of this section as
"raw glandless cottonseed kernels for use in cooked hard candy".
(d) The Food and Drug Administration and the Environmental
Protection Agency have determined that glandless cottonseed kernels
permitted for use by this section are a distinct commodity from glanded
cottonseed.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.896]
[Page 116]
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. 172.896 Dried yeasts.
Dried yeast (Saccharomyces cerevisiae and Saccharomyces fragilis)
and dried torula yeast (Candida utilis) may be safely used in food
provided the total folic acid content of the yeast does not exceed 0.04
milligram per gram of yeast (approximately 0.008 milligram of
pteroyglutamic acid per gram of yeast).
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.898]
[Page 116]
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. 172.898 Bakers yeast glycan.
Bakers yeast glycan may be safely used in food in accordance with
the following conditions:
(a) Bakers yeast glycan is the comminuted, washed, pasteurized, and
dried cell walls of the yeast, Saccharomyces cerevisiae. It is composed
principally of long chain carbohydrates, not less than 85 percent on a
dry solids basis. The carbohydrate is composed of glycan and mannan
units in approximately a 2:1 ratio.
(b) The additive meets the following specifications on a dry weight
basis: Less than 0.4 part per million (ppm) arsenic, 0.13 ppm cadmium,
0.2 ppm lead, 0.05 ppm mercury, 0.09 ppm selenium, and 10 ppm zinc.
(c) The viable microbial content of the finished ingredient is:
(1) Less than 10,000 organisms/gram by aerobic plate count.
(2) Less than 10 yeasts and molds/gram.
(3) Negative for Salmonella, E. coli, coagulase positive
Staphylococci, Clostridium perfringens, Clostridium botulinum, or any
other recognized microbial pathogen or any harmful microbial toxin.
(d) The additive is used or intended for use in the following foods
when standards of identity established under section 401 of the Act do
not preclude such use:
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Use Limitations
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(1) In salad dressings as an emulsifier Not to exceed a
and emulsifier salt as defined in Sec. concentration of 5 percent
170.3(o)(8) of this chapter, stabilizer of the finished salad
and thickener as defined in Sec. dressing.
170.3(o)(28) of this chapter, or
texturizer as defined in Sec.
170.3(o)(32) of this chapter.
(2) In frozen dessert analogs as a In an amount not to exceed
stabilizer and thickener as defined in good manufacturing
Sec. 170.3(o)(28) of this chapter, or practice.
texturizer as defined in Sec.
170.3(o)(32) of this chapter.
(3) In sour cream analogs as a stabilizer Do.
and thickener as defined in Sec.
170.3(o)(28) of this chapter, or
texturizer as defined in Sec.
170.3(o)(32) of this chapter.
(4) In cheese spread analogs as a Do.
stabilizer and thickener as defined in
Sec. 170.3(o)(28) of this chapter, or
texturizer as defined in Sec.
170.3(o)(32) of this chapter.
(5) In cheese-flavored and sour cream- Do.
flavored snack dips as a stabilizer and
thickener as defined in Sec.
170.3(o)(28) of this chapter, or
texturizer as defined in Sec.
170.3(o)(32) of this chapter.
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(e) The label and labeling of the ingredient shall bear adequate
directions to assure that use of the ingredient complies with this
regulation.
[42 FR 14491, Mar. 15, 1977, as amended at 45 FR 58836, Sept. 5, 1980]
