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
t