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: 21CFR184.1]
[Page 470-471]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart A--General Provisions
Sec. 184.1 Substances added directly to human food affirmed as generally recognized as safe (GRAS).
(a) The direct human food ingredients listed in this part have been
reviewed by the Food and Drug Administration and determined to be
generally recognized as safe (GRAS) for the purposes and under the
conditions prescribed. The regulations in this part shall sufficiently
describe each ingredient to identify the characteristics of the
ingredient that has been affirmed as GRAS and to differentiate it from
other possible versions of the ingredient that have not been affirmed as
GRAS. Ingredients affirmed as GRAS in this part are also GRAS as
indirect human food ingredients, subject to any limitations prescribed
in parts 174, 175, 176, 177, 178 or Sec. 179.45 of this chapter or in
part 186 of this chapter. The purity specifications in this part do not
apply when the ingredient is used in indirect applications. However,
when used in indirect applications, the ingredient must be of a purity
suitable for its intended use in accordance with Sec. 170.30(h)(1) of
this chapter.
(b) Any ingredient affirmed as GRAS in this part shall be used in
accordance with current good manufacturing practice. For the purpose of
this part, current good manufacturing practice includes the requirements
that a direct human food ingredient be of appropriate food grade; that
it be prepared and handled as a food ingredient; and that the quantity
of the ingredient added to food does not exceed the amount reasonably
required to accomplish the intended physical, nutritional, or other
technical effect in food.
(1) If the ingredient is affirmed as GRAS with no limitations on its
conditions of use other than current good manufacturing practice, it
shall be regarded as GRAS if its conditions of use are consistent with
the requirements of paragraph (b), (c), and (d) of this section. When
the Food and Drug Administration (FDA) determines that it is
appropriate, the agency will describe one or more current good
manufacturing practice conditions of use in the regulation that affirms
the GRAS status of the ingredient. For example, when the safety of an
ingredient has been evaluated on the basis of limited conditions of use,
the agency will describe in the regulation that affirms the GRAS status
of the ingredient, one or more of these limited conditions of use, which
may include the category of food(s), the technical effect(s) or
functional use(s) of the ingredient, and the level(s) of use. If the
ingredient is used under conditions that are significantly different
from those described in the regulation, that use of the ingredient may
not be GRAS. In such a case, a manufacturer may not rely on the
regulation as authorizing that use but shall independently establish
that that use is GRAS or shall use the ingredient in accordance with a
food additive regulation. Persons seeking FDA approval of an independent
determination that a use of an ingredient is GRAS may submit a GRAS
petition in accordance with Sec. 170.35 of this chapter.
(2) If the ingredient is affirmed as GRAS with specific
limitation(s), it shall be used in food only within such limitation(s),
including the category of food(s), the functional use(s) of the
ingredient, and the level(s) of use. Any use of such an ingredient not
in full compliance with each such established limitation shall require a
food additive regulation.
(3) If the ingredient is affirmed as GRAS for a specific use,
without a general evaluation of use of the ingredient, other uses may
also be GRAS.
[[Page 471]]
(c) The listing of a food ingredient in this part does not authorize
the use of such substance in a manner that may lead to deception of the
consumer or to any other violation of the Federal Food, Drug, and
Cosmetic Act (the Act).
(d) The listing of more than one ingredient to produce the same
technological effect does not authorize use of a combination of two or
more ingredients to accomplish the same technological effect in any one
food at a combined level greater than the highest level permitted for
one of the ingredients.
(e) If the Commissioner of Food and Drugs is aware of any prior
sanction for use of an ingredient under conditions different from those
proposed to be affirmed as GRAS, he will concurrently propose a separate
regulation covering such use of the ingredient under part 181 of this
chapter. If the Commissioner is unaware of any such applicable prior
sanction, the proposed regulation will so state and will require any
person who intends to assert or rely on such sanction to submit proof of
its existence. Any regulation promulgated pursuant to this section
constitutes a determination that excluded uses would result in
adulteration of the food in violation of section 402 of the Act, and the
failure of any person to come forward with proof of such an applicable
prior sanction in response to the proposal will constitute a waiver of
the right to assert or rely on such sanction at any later time. The
notice will also constitute a proposal to establish a regulation under
part 181 of this chapter, incorporating the same provisions, in the
event that such a regulation is determined to be appropriate as a result
of submission of proof of such an applicable prior sanction in response
to the proposal.
(f) The label and labeling of the ingredient and any intermediate
mix of the ingredient for use in finished food shall bear, in addition
to the other labeling required by the Act:
(1) The name of the ingredient, except where exempted from such
labeling in part 101 of this chapter.
(2) A statement of concentration of the ingredient in any
intermediate mix; or other information to permit a food processor
independently to determine that use of the ingredients will be in
accordance with any limitations and good manufacturing practice
gudelines prescribed.
(3) Adequate directions for use to provide a final food product that
complies with any limitations prescribed for the ingredient(s).
[42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977;
48 FR 48457, 48459, Oct. 19, 1983; 62 FR 15110, Mar. 31, 1997]
[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: 21CFR184.1005]
[Page 471-472]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1005 Acetic acid.
(a) Acetic acid (C2H4O2, CAS Reg.
No. 64-19-7) is known as ethanoic acid. It occurs naturally in plant and
animal tissues. It is produced by fermentation of carbohydrates or by
organic synthesis. The principal synthetic methods currently employed
are oxidation of acetaldehyde derived from ethylene, liquid phase
oxidation of butane, and reaction of carbon monoxide with methanol
derived from natural gas.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 8, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) The ingredient is used as a curing and pickling agent as defined
in Sec. 170.3(o)(5) of this chapter; flavor enhancer as defined in
Sec. 170.3(o)(11) of this chapter; flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter; pH control agent as
defined in Sec. 170.3(o)(23) of this chapter; as a solvent and vehicle
as defined in Sec. 170.3(o)(27) of this chapter; and as a boiler water
additive complying with Sec. 173.310 of this chapter.
(d) The ingredient is used in food at levels not to exceed current
good manufacturing practice in accordance with Sec. 184.1(b)(1). Current
good manufacturing practice results in a maximum level as served, of
0.25 percent for baked goods as defined in Sec. 170.3(n)(1) of this
chapter; 0.8 percent for cheeses as defined in Sec. 170.3(n)(5) of this
chapter
[[Page 472]]
and dairy product analogs as defined in Sec. 170.3(n)(10) of this
chapter; 0.5 percent for chewing gum as defined in Sec. 170.3(n)(6) of
this chapter; 9.0 percent for condiments and relishes as defined in
Sec. 170.3(n)(8) of this chapter; 0.5 percent for fats and oils as
defined in Sec. 170.3(n)(12) of this chapter; 3.0 percent for gravies
and sauces as defined in Sec. 170.3(n)(24) of this chapter; 0.6 percent
for meat products as defined in Sec. 170.3(n)(29) of this chapter; and
0.15 percent or less for all other food categories. The ingredient may
also be used in boiler water additives at levels not to exceed current
good manufacturing practice.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[47 FR 27814, June 25, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1007]
[Page 472]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1007 Aconitic acid.
(a) Aconitic acid (1,2,3-propenetricarboxylic acid
(C6H6O6), CAS Reg. No. 000499-12-7)
occurs in the leaves and tubers of Aconitum napellus L. and other
Ranunculaceae. Transaconitic acid can be isolated during sugarcane
processing, by precipitation as the calcium salt from cane sugar or
molasses. It may be synthesized by sulfuric acid dehydration of citric
acid, but not by the methanesulfonic acid method.
(b) The ingredient meets the following specifications:
(1) Assay. Not less than 98.0 percent of
C3H3(COOH)3, using the "Food Chemicals
Codex," 4th ed. (1996), pp. 102-103, test for citric acid, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51, and a molecular weight of 174.11. Copies of the material
incorporated by reference 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.
(2) Melting point. Not less than 195 deg.C and the determination
results in decomposition of aconitic acid.
(3) Heavy metals (as Pb). Not more than 10 parts per million.
(4) Arsenic (as As). Not more than 3 parts per million.
(5) Oxalate. Passes test.
(6) Readily carbonizable substances. Passes the test for citric acid
of the "Food Chemicals Codex," 4th ed. (1996), pp. 102-103, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given in
paragraph (b)(1) of this section.
(7) Residue on ignition. Not more than 0.1 percent as determined by
the "Food Chemicals Codex," 4th ed. (1996), pp. 102-103, test for
citric acid, which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation
by reference is given in paragraph (b)(1) of this section.
(c) The ingredient is used as a flavoring substance and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter.
(d) The ingredient is used in food, in accordance with
Sec. 184.1(b)(1), at levels not to exceed good manufacturing practice.
Current good manufacturing practice results in a maximum level, as
served, of 0.003 percent for baked goods as defined in Sec. 170.3(n)(1)
of this chapter, 0.002 percent for alcoholic beverages as defined in
Sec. 170.3(n)(2) of this chapter, 0.0015 percent for frozen dairy
products as defined in Sec. 170.3(n)(20) of this chapter, 0.0035 percent
for soft candy as defined in Sec. 170.3(n)(38) of this chapter, and
0.0005 percent or less for all other food categories.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[43 FR 47724, Oct. 17, 1978, as amended at 49 FR 5610, Feb. 14, 1984; 64
FR 1759, Jan. 12, 1999]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1009]
[Page 472-473]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1009 Adipic acid.
(a) Adipic acid (C6H10O4, CAS Reg.
No. 00124-04-9) is also known as 1,4-butanedicarboxylic acid or hexane-
dioic acid. It is prepared by nitric acid oxidation of cyclohexanol or
cyclohexanone or a mixture of the two.
[[Page 473]]
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 11, which is incorporated by reference (copies
are available from the National Academy Press, 2101 Constitution Ave.,
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408), and the following additional specifications:
(1) The adipic acid is converted to its corresponding amide. The
amide is purified by recrystallization from water or aqueous ethanol.
The melting range of the amide is 219 deg. to 220 deg.C.
(2) The adipic acid is converted to its corresponding bis-p-p-
bromophenacyl ester. The ester is purified by recrystallization from
ethanol. The melting range of the ester is 153 deg. to 154 deg.C.
(c) The ingredient is used as a flavoring agent as defined in
Sec. 170.3(o)(12) of this chapter; leavening agent as defined in
Sec. 170.3(o)(17) of this chapter; and pH control agent as defined in
Sec. 170.3(o)(23) of this chapter.
(d) The ingredient is used in foods at levels not to exceed current
good manufacturing practice in accordance with Sec. 184.1(b)(1). Current
good manufacturing practice results in maximum levels, as served, of
0.05 percent for baked goods as defined in Sec. 170.3(n)(1) of this
chapter; 0.005 percent for nonalcoholic beverages as defined in
Sec. 170.3(n)(3) of this chapter; 5.0 percent for condiments and
relishes as defined in Sec. 170.3(n)(8) of this chapter; 0.45 percent
for dairy product analogs as defined in Sec. 170.3(n)(10) of this
chapter; 0.3 percent for fats and oil as defined in Sec. 170.3(n)(12) of
this chapter; 0.0004 percent for frozen dairy desserts as defined in
Sec. 170.3(n)(20) of this chapter; 0.55 percent for gelatin and puddings
as defined in Sec. 170.3(n)(22) of this chapter; 0.1 percent for gravies
as defined in Sec. 170.3(n)(24) of this chapter; 0.3 percent for meat
products as defined in Sec. 170.3(n)(29) of this chapter; 1.3 percent
for snack foods as defined in Sec. 170.3(n)(37) of this chapter; and
0.02 percent or less for all other food categories.
(e) Prior sanctions for adipic acid different from the uses
established in this section do not exist or have been waived.
[47 FR 27810, June 25, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1011]
[Page 473]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1011 Alginic acid.
(a) Alginic acid is a colloidal, hydrophilic polysaccharide obtained
from certain brown algae by alkaline extraction.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 13, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(2), the ingredient is used in
food only within the following specific limitations:
------------------------------------------------------------------------
Maximum level of
Category of food use in food (as Functional use
served)
------------------------------------------------------------------------
Soup and soup mixes, Sec. Not to exceed Emulsifier,
170.3(n) (40) of this chapter. current good emulsifier salt,
manufacturing Sec. 170.3(o)(8)
practice. of this chapter;
formulation aid,
Sec. 170.3(o)(14
) of this
chapter;
stabilizer,
thickener, Sec.
170.3(o)(28) of
this chapter.
------------------------------------------------------------------------
(d) Prior sanctions for this ingredient different from the use
established in this section do not exist or have been waived.
[47 FR 47375, Oct. 26, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1012]
[Page 473-474]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1012 [alpha]-Amylase enzyme preparation from Bacillus stearothermophilus.
(a) [alpha]-Amylase enzyme preparation is obtained from the culture
filtrate that results from a pure culture fermentation of a
nonpathogenic and nontoxicogenic strain of Bacillus stearothermophilus.
Its characterizing enzyme activity is [alpha]-amylase (1,4 [alpha]-D
glucan glucanohydrolase (E.C. 3.2.1.1)).
(b) The ingredient meets the general and additional requirements for
enzyme preparations in the "Food Chemicals Codex," 3d ed. (1981), pp.
107-110, which is incorporated by reference in accordance with 5 U.S.C.
552(a) and 1
[[Page 474]]
CFR part 51. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of Premarket Approval (HFS-200), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 1110 Vermont Ave. NW.,
suite 1200, Washington, DC, or the Office of the Federal Register, 800
North Capitol St. NW., suite 700, Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practices.
The affirmation of this ingredient as GRAS as a direct human food
ingredient is based upon the following current good manufacturing
practice conditions of use:
(1) The ingredient is used as an enzyme, as defined in
Sec. 170.3(o)(9) of this chapter, in the hydrolysis of edible starch to
produce maltodextrins and nutritive carbohydrate sweeteners.
(2) The ingredient is used at levels not to exceed current good
manufacturing practices.
[60 FR 55789, Nov. 3, 1995]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1021]
[Page 474]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1021 Benzoic acid.
(a) Benzoic acid is the chemical benzenecarboxylic acid
(C7H6O2), occurring in nature in free
and combined forms. Among the foods in which benzoic acid occurs
naturally are cranberries, prunes, plums, cinnamon, ripe cloves, and
most berries. Benzoic acid is manufactured by treating molten phthalic
anhydride with steam in the presence of a zinc oxide catalyst, by the
hydrolysis of benzotrichloride, or by the oxidation of toluene with
nitric acid or sodium bichromate or with air in the presence of a
transition metal salt catalyst.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), p. 35, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as an antimicrobial agent as defined in
Sec. 170.3(o)(2) of this chapter, and as a flavoring agent and adjuvant
as defined in Sec. 170.3(o)(12) of this chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practice. Current usage results in a maximum level of 0.1
percent in food. (The Food and Drug Administration has not determined
whether significantly different conditions of use would be GRAS).
(e) Prior sanctions for this ingredient different from those uses
established in this section, or different from that set forth in part
181 of this chapter, do not exist or have been waived.
[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 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: 21CFR184.1024]
[Page 474]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1024 Bromelain.
(a) Bromelain (CAS Reg. No. 9001-00-7) is an enzyme preparation
derived from the pineapples Ananas comosus and A. bracteatus L. It is a
white to light tan amorphous powder. Its characterizing enzyme activity
is that of a peptide hydrolase (EC 3.4.22.32).
(b) The ingredient meets the general requirements and additional
requirements for enzyme preparations in the Food Chemicals Codex, 3d ed.
(1981), p. 110, which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National
Academy Press, 2101 Constitution Ave. NW., Washington, DC, or may be
examined at the Office of Premarket Approval (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and the
Office of the Federal Register, 800 North Capitol St. NW., suite 700,
Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as GRAS as a direct food ingredient
is based upon the following current good manufacturing practice
conditions of use:
(1) The ingredient is used as an enzyme as defined in
Sec. 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
[60 FR 32910, June 26, 1995]
[[Page 475]]
[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: 21CFR184.1025]
[Page 475]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1025 Caprylic acid.
(a) Caprylic acid [CH3(CH2)6COOH,
CAS Reg. No. 124-07-2] is the chemical name for octanoic acid. It is
considered to be a short or medium chain fatty acid. It occurs normally
in various foods and is commercially prepared by oxidation of n-octanol
or by fermentation and fractional distillation of the volatile fatty
acids present in coconut oil.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), p. 207, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as a flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter.
(d) The ingredient is used in foods in accordance with
Sec. 184.1(b)(1), at levels not to exceed good manufacturing practice.
Current good manufacturing practices result in maximum levels, as
served, of: 0.013 percent for baked goods as defined in Sec. 170.3(n)(1)
of this chapter; 0.04 percent for cheeses as defined in Sec. 170.3(n)(5)
of this chapter; 0.005 percent for fats and oils as defined in
Sec. 170.3(n)(12) of this chapter, for frozen dairy desserts as defined
in Sec. 170.3(n)(20) of this chapter, for gelatins and puddings as
defined in Sec. 170.3(n)(22) of this chapter, for meat products as
defined in Sec. 170.3(n)(29) of this chapter, and for soft candy as
defined in Sec. 170.3(n)(38) of this chapter; 0.016 percent for snack
foods as defined in Sec. 170.3(n)(37) of this chapter; and 0.001 percent
or less for all other food categories.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[43 FR 19843, May 9, 1978, as amended at 49 FR 5611, Feb. 14, 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: 21CFR184.1027]
[Page 475]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1027 Mixed carbohydrase and protease enzyme product.
(a) Mixed carbohydrase and protease enzyme product is an enzyme
preparation that includes carbohydrase and protease activity. It is
obtained from the culture filtrate resulting from a pure culture
fermentation of a nonpathogenic strain of B. licheniformis.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 107, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe as a
direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an enzyme, as defined in
Sec. 170.3(o)(9) of this chapter, to hydrolyze proteins or
carbohydrates.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: alcoholic beverages, as
defined in Sec. 170.3(n)(2) of this chapter, candy, nutritive
sweeteners, and protein hydrolyzates.
[48 FR 240, Jan. 4, 1983]
[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: 21CFR184.1033]
[Page 475-476]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1033 Citric acid.
(a) Citric acid (C6H8O7, CAS Reg.
No. 77-92-9) is the compound 2-hydroxy-1,2,3-propanetricarboxylic acid.
It is a naturally occurring constituent of plant and animal tissues. It
occurs as colorless crystals or a white powder and may be anhydrous or
contain one mole of water per mole of citric acid. Citric acid may be
produced by recovery from sources such as lemon or pineapple juice; by
mycological fermentation using Candida spp., described in Secs. 173.160
and 173.165 of this chapter; and by the solvent extraction process
described in Sec. 173.280 of this chapter for the recovery of citric
acid from Aspergillus niger fermentation liquor.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d ed. (1981), pp. 86-87, and its third supplement (March 1992),
pp. 107-108, which are incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR
[[Page 476]]
part 51. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, and the Center for Food
Safety and Applied Nutrition (HFS-200), 5100 Paint Branch Pkwy., College
Park, MD 20740, or may be examined at the Office of the Federal
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitations other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[59 FR 63895, Dec. 12, 1994]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1034]
[Page 476]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1034 Catalase (bovine liver).
(a) Catalase (bovine liver) (CAS Reg. No. 9001-05-2) is an enzyme
preparation obtained from extracts of bovine liver. It is a partially
purified liquid or powder. Its characterizing enzyme activity is
catalase (EC 1.11.1.6).
(b) The ingredient meets the general requirements and additional
requirements for enzyme preparations in the Food Chemicals Codex, 3d ed.
(1981), p. 110, which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National
Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or may
be examined at the Office of Premarket Approval (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and the
Office of the Federal Register, 800 North Capitol St. NW., suite 700,
Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as GRAS as a direct food ingredient
is based upon the following current good manufacturing practice
conditions of use:
(1) The ingredient is used as an enzyme as defined in
Sec. 170.3(o)(9) of this chapter to decompose hydrogen peroxide.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
[60 FR 32910, June 26, 1995]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1061]
[Page 476]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1061 Lactic acid.
(a) Lactic acid (C3H6O3, CAS Reg.
Nos.: dl mixture, 598-82-3; l-isomer, 79-33-4; d-isomer, 10326-41-7),
the chemical 2-hydroxypropanoic acid, occurs naturally in several foods.
It is produced commercially either by fermentation of carbohydrates such
as glucose, sucrose, or lactose, or by a procedure involving formation
of lactonitrile from acetaldehyde and hydrogen cyanide and subsequent
hydrolysis to lactic acid.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 159, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Avenue,
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as an antimicrobial agent as defined in
Sec. 170.3(o)(2) of this chapter; a curing and pickling agent as defined
in Sec. 170.3(o)(5) of this chapter; a flavor enhancer as defined in
Sec. 170.3(o)(11) of this chapter; a flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter; a pH control agent as
defined in Sec. 170.3(o)(23) of this chapter; and a solvent and vehicle
as defined in Sec. 170.3(o)(27) of this chapter.
(2) The ingredient is used in food, except in infant foods and
infant formulas, at levels not to exceed current good manufacturing
practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[49 FR 35367, Sept. 7, 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: 21CFR184.1063]
[Page 476-477]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1063 Enzyme-modified lecithin.
(a) Enzyme-modified lecithin is prepared by treating lecithin with
either
[[Page 477]]
phospholipase A2 (EC 3.1.1.4) or pancreatin.
(b) The ingredient meets the specifications in paragraphs (b)(1)
through (b)(8) of this section. Unless otherwise noted, compliance with
the specifications listed below is determined according to the methods
set forth for lecithin in the Food Chemicals Codex, 4th ed. (1996), pp.
220-221, which are incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies are available from the National Academy
Press, 2101 Constitution Ave. NW., Washington DC 20418, or may be
examined at the Center for Food Safety and Applied Nutrition's Library,
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.
(1) Acetone-insoluble matter (phosphatides), not less than 50.0
percent.
(2) Acid value, not more than 40.
(3) Lead, not more than 1.0 part per million, as determined by
atomic absorption spectroscopy.
(4) Heavy metals (as Pb), not more than 20 parts per million.
(5) Hexane-insoluble matter, not more than 0.3 percent.
(6) Peroxide value, not more than 20.
(7) Water, not more than 4.0 percent.
(8) Lysolecithin, 50 to 80 mole percent of total phosphatides as
determined by "Determination of Lysolecithin Content of Enzyme-Modified
Lecithin: Method I," dated 1985, which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available
from the Division of Petition Control, Center for Food Safety and
Applied Nutrition (HFS-215), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or may be examined at the Center
for Food Safety and Applied Nutrition's Library, 5100 Paint Branch
Pkwy., College Park, MD 20740, or at the Office of the Federal Register,
800 North Capitol St. NW., suite 700, Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe as a
direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an emulsifier as defined in
Sec. 170.3(o)(8) of this chapter.
(2) The ingredient is used at levels not to exceed current good
manufacturing practice.
[61 FR 45889, Aug. 30, 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: 21CFR184.1065]
[Page 477-478]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1065 Linoleic acid.
(a) Linoleic acid ((Z, Z)-9, 12-octadecadienoic acid
(C17H31COOH) (CAS Reg. No. 60-33-3)), a straight
chain unsaturated fatty acid with a molecular weight of 280.5, is a
colorless oil at room temperature. Linoleic acid may be prepared from
edible fats and oils by various methods including hydrolysis and
saponification, the Twitchell method, low pressure splitting with
catalyst, continuous high pressure counter current splitting, and medium
pressure autoclave splitting with catalyst.
(b) FDA is developing food-grade specifications for linoleic acid in
cooperation with the National Academy of Sciences. In the interim, this
ingredient must be of a purity suitable for its intended use. The
ingredient must also meet the specifications in Sec. 172.860(b) of this
chapter.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter and as a nutrient
supplement as defined in Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice. The ingredient may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the act) or with regulations promulgated under section
412(a)(2) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in
[[Page 478]]
this section do not exist or have been waived.
[49 FR 48534, Dec. 13, 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: 21CFR184.1069]
[Page 478]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1069 Malic acid.
(a) Malic acid (C4H6O5, CAS Reg.
No. of L-form 97-67-6, CAS Reg. No. of DL-form 617-48-1) is the common
name for 1-hydroxy-1, 2-ethanedicarboxylic acid. L (+) malic acid,
referred to as L-malic acid, occurs naturally in various foods. Racemic
DL-malic acid does not occur naturally. It is made commercially by
hydration of fumaric acid or maleic acid.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), pp. 183-184, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredients are used as a flavor enhancer as defined in
Sec. 170.3(o)(11) of this chapter, flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter, and pH control agent as
defined in Sec. 170.3(o)(23) of this chapter.
(d) The ingredients are used in food, except baby food, at levels
not to exceed good manufacturing practice in accordance with
Sec. 184.1(b)(1). Current good manufacturing practice results in a
maximum level, as served, of 3.4 percent for nonalcoholic beverages as
defined in Sec. 170.3(n)(3) of this chapter; 3.0 percent for chewing gum
as defined in Sec. 170.3(n)(6) of this chapter; 0.8 percent for
gelatins, puddings, and fillings as defined in Sec. 170.3(n)(22) of this
chapter; 6.9 percent for hard candy as defined in Sec. 170.3(n)(25) of
this chapter; 2.6 percent for jams and jellies as defined in
Sec. 170.3(n)(28) of this chapter; 3.5 percent for processed fruits and
fruit juices as defined in Sec. 170.3(n)(35) of this chapter; 3.0
percent for soft candy as defined in Sec. 170.3(n)(38) of this chapter;
and 0.7 percent for all other food categories.
(e) Prior sanctions for malic acid different from the uses
established in this section do not exist or have been waived.
[44 FR 20656, Apr. 6, 1979, as amended at 49 FR 5611, Feb. 14, 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: 21CFR184.1077]
[Page 478-479]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1077 Potassium acid tartrate.
(a) Potassium acid tartrate
(C4H5KO6, CAS Reg. No. 868-14-4) is the
potassium acid salt of l-(+)-tartaric acid and is also called potassium
bitartrate or cream of tartar. It occurs as colorless or slightly opaque
crystals or as a white, crystalline powder. It has a pleasant, acid
taste. It is obtained as a byproduct of wine manufacture.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), P. 238, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as an anticaking agent as defined in
Sec. 170.3(o)(1) of this chapter; an antimicrobial agent as defined in
Sec. 170.3(o)(2) of this chapter; a formulation aid as defined in
Sec. 170.3(o)(14) of this chapter; a humectant as defined in
Sec. 170.3(o)(16) of this chapter; a leavening agent as defined in
Sec. 170.3(o)(17) of this chapter; A pH control agent as defined in
Sec. 170.3(o)(23) of this chapter; a processing aid as defined in
Sec. 170.3(o)(24) of this chapter; a stabilizer and thickener as defined
in Sec. 170.3(o)(28) of this chapter; and a surface-active agent as
defined in Sec. 170.3(o)(29) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods as defined in
Sec. 170.3(n)(1) of this chapter; confections and frostings as defined
in Sec. 170.3(n)(9) of this chapter; gelatins and puddings as defined in
Sec. 170.3(n)(22) of this chapter; hard candy as defined in
Sec. 170.3(n)(25) of this chapter; jams and jellies as defined in
Sec. 170.3(n)(28) of this chapter; and soft candy as defined in
Sec. 170.3(n)(38) of this chapter.
[[Page 479]]
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52446, Nov. 18, 1983]
[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: 21CFR184.1081]
[Page 479]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1081 Propionic acid.
(a) Propionic acid (C3H6O2, CAS
Reg. No. 79-09-4) is an oily liquid having a slightly pungent, rancid
odor. It is manufactured by chemical synthesis or by bacterial
fermentation.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 254, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as an antimicrobial agent as defined in
Sec. 170.3(o)(2) of this chapter and a flavoring agent as defined in
Sec. 170.3(o)(12) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[49 FR 13141, Apr. 3, 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: 21CFR184.1090]
[Page 479]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1090 Stearic acid.
(a) Stearic acid (C16H36O2, CAS
Reg. No. 57-11-4) is a white to yellowish white solid. It occurs
naturally as a glyceride in tallow and other animal or vegetable fats
and oils and is a principal constituent of most commercially
hydrogenated fats. It is produced commercially from hydrolyzed tallow
derived from edible sources or from hydrolyzed, completely hydrogenated
vegetable oil derived from edible sources.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 313, which is incorporated by reference, and
the requirements of Sec. 172.860(b)(2) of this chapter. Copies of the
Food Chemicals Codex are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or available for inspection
at the Office of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52445, Nov. 18, 1983, as amended at 50 FR 49536, Dec. 3, 1985]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1091]
[Page 479-480]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1091 Succinic acid.
(a) Succinic acid (C4H6O4, CAS Reg.
No. 110-15-6), also referred to as amber acid and ethylenesuccinic acid,
is the chemical 1,4-butanedioic acid. It is commercially prepared by
hydrogenation of maleic or fumaric acid. It can also be produced by
aqueous alkali or acid hydrolysis of succinonitrile.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), pp. 314-315, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as a flavor enhancer as defined in
Sec. 170.3(o)(11) of this chapter and pH control agent as defined in
Sec. 170.3(o)(23) of this chapter.
[[Page 480]]
(d) The ingredient is used in food at levels not to exceed good
manufacturing practice in accordance with Sec. 184.1(b)(1). Current good
manufacturing practice results in a maximum level, as served, of 0.084
percent in condiments and relishes as defined in Sec. 170.3(n)(8) of
this chapter and 0.0061 percent in meat products as defined in
Sec. 170.3(n)(29) of this chapter.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[44 FR 20657, Apr. 6, 1979, as amended at 49 FR 5611, Feb. 14, 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: 21CFR184.1095]
[Page 480]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1095 Sulfuric acid.
(a) Sulfuric acid (H2SO4, CAS Reg. No. 7664-
93-9), also known as oil of vitriol, is a clear, colorless, oily liquid.
It is prepared by reacting sulfur dioxide (SO2) with oxygen
and mixing the resultant sulfur trioxide (SO3) with water, or
by reacting nitric oxide (NO) with sulfur dioxide and water.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), pp. 317-318, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as a pH control agent as defined in
Sec. 170.3(o)(23) of this chapter and processing aid as defined in
Sec. 170.3(o)(24) of this chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practice in accordance with Sec. 184.1(b)(1). Current good
manufacturing practice results in a maximum level, as served, of 0.014
percent for alcoholic beverages as defined in Sec. 170.3(n)(2) of this
chapter and 0.0003 percent for cheeses as defined in Sec. 170.3(n)(5) of
this chapter.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[45 FR 6085, Jan. 25, 1980, as amended at 49 FR 5611, Feb. 14, 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: 21CFR184.1097]
[Page 480-481]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1097 Tannic acid.
(a) Tannic acid (CAS Reg. No. 1401-55-4), or hydrolyzable
gallotannin, is a complex polyphenolic organic structure that yields
gallic acid and either glucose or quinic acid as hydrolysis products. It
is a yellowish-white to light brown substance in the form of an
amorphous, bulky powder, glistening scales, or spongy masses. It is also
ordorless, or has a faint characteristic odor, and has an astringent
taste. Tannic acid is obtained by solvent extraction of nutgalls or
excrescences that form on the young twigs of Quercus infectoria Oliver
and related species of Quercus. Tannic acid is also obtained by solvent
extraction of the seed pods of Tara (Caesalpinia spinosa) or the
nutgalls of various sumac species, including Rhus semialata, R.
coriaria, R. galabra, and R. typhia.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 319, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c)(1) In accordance with Sec. 184.1(b)(2), the ingredient is used
in food only within the following specific limitations:
------------------------------------------------------------------------
Maximum
level of use
Category of food in food (as Functional use
served)
(percent)
------------------------------------------------------------------------
Baked goods and baking mixes, Sec. 0.01 Flavoring agent and
170.3(n)(1) of this chapter. adjuvant, Sec.
170.3(o)(12) of this
chapter.
Alcoholic beverages, Sec. 0.015 Flavor enhancer, Sec.
170.3(n)(2) of this chapter. 170.3(o)(11) of this
chapter; flavoring
agent and adjuvant,
Sec. 170.3(o)(12) of
this chapter;
processing aid, Sec.
170.3(o)(24) of this
chapter.
Nonalcoholic beverages and 0.005 Flavoring agent and
beverage bases, Sec. 170.3(n)(3) adjuvant, Sec.
of this chapter and for gelatins, 170.3(o)(12) of this
puddings, and fillings, Sec. chapter; pH control
170.3(n)(22) of this chapter. agent, Sec.
170.3(o)(23) of this
chpater.
[[Page 481]]
Frozen dairy desserts and mixes, 0.04 Flavoring agent and
Sec. 170.3(n)(20) of this adjuvant, Sec.
chapter and for soft candy, Sec. 170.3(o)(12) of this
170.3(n)(38) of this chapter. chapter.
Hard candy and cough drops, Sec. 0.013 Do.
170.3(n)(25) of this chapter.
Meat products, Sec. 170.3(n)(29) 0.001 Do.
of this chapter.
------------------------------------------------------------------------
(2) Tannic acid may be used in rendered animal fat in accordance
with 9 CFR 318.7.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 21043, May 22, 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: 21CFR184.1099]
[Page 481]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1099 Tartaric acid.
(a) Food grade tartaric acid
(C4H6O6, CAS Reg. No. 87-69-4) has the
l configuration. The l form of tartaric acid is dextrorotatory in
solution and is also known as l-(+)-tartaric acid. Tartaric acid occurs
as colorless or translucent crystals or as a white, crystalline powder.
It is odorless and has an acid taste. It is obtained as a byproduct of
wine manufacture.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), P. 320, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a firming agent as defined in
Sec. 170.3(o)(10) of this chapter; a flavor enhancer as defined in
Sec. 170.3(o)(11) of this chapter; a flavoring agent as defined in
Sec. 170.3(o)(12) of this chapter; a humectant as defined in
Sec. 170.3(o)(16) of this chapter; and a pH control agent as defined in
Sec. 170.3(o)(23) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52447, Nov. 18, 1983, as amended at 50 FR 49536, Dec. 3, 1985]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1101]
[Page 481-482]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1101 Diacetyl tartaric acid esters of mono- and diglycerides.
(a) Diacetyl tartaric acid esters of mono- and diglycerides, also
know as DATEM, are composed of mixed esters of glycerin in which one or
more of the hydroxyl groups of glycerin has been esterified by diacetyl
tartaric acid and by fatty acids. The ingredient is prepared by the
reaction of diacetyl tartaric anhydride with mono- and diglycerides that
are derived from edible sources.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d. Ed. (1981), pp. 98-99, which is incorporated by reference in
accordance with 5 U.S.C. 552(a). Copies are available from the National
Academy Press, 2101 Constitution Avenue NW., Washington, DC 20418, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20005.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
[[Page 482]]
(1) The ingredient is used in food as an emulsifier and emulsifier
salt as defined in Sec. 170.3(o)(8) of this chapter and a flavoring
agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods and baking mixes
as defined in Sec. 170.3(n)(l) of this chapter; nonalcoholic beverages
as defined in Sec. 170.3(n)(3) of this chapter; confections and
frostings as defined in Sec. 170.3(n)(9) of this chapter; dairy product
analogs as defined in Sec. 170.3(n)(10) of this chapter; and fats and
oils as defined in Sec. 170.3(n)(12) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(e) Labeling: The acronym "DATEM" may be used on food labeling as
the alternate common or usual name for the ingredient diacetyl tartaric
acid esters of mono- and diglycerides.
[54 FR 7403, Feb. 21, 1989, as amended at 54 FR 13168, Mar. 31, 1989; 54
FR 18382, Apr. 28, 1989; 60 FR 15872, Mar. 28, 1995]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1115]
[Page 482]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1115 Agar-agar.
(a) Agar-agar (CAS Reg. No. PM 9002-18-0) is a dried, hydrophyllic,
colloidal polysaccharide extracted from one of a number of related
species of red algae (class Rhodophyceae).
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), p. 11, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used in food in accordance with
Sec. 184.1(b)(2) under the following conditions:
Maximum Usage Levels Permitted
------------------------------------------------------------------------
Foods (as served) Percent Functions
------------------------------------------------------------------------
Baked goods and baking mixes, 0.8 Drying agent, Sec.
Sec. 170.3(n)(1) of this 170.3(o)(7) of this chapter;
chapter. flavoring agent, Sec.
170.3(o)(12) of this
chapter; stabilizer,
thickener, Sec.
170.3(o)(28) of this
chapter.
Confections and frostings, 2.0 Flavoring agent, Sec.
Sec. 170.3(n)(9) of this 170.3(o)(12) of this
chapter. chapter; stabilizer,
thickener, Sec.
170.3(o)(28) of this
chapter; surface finisher,
Sec. 170.3(o)(30) of this
chapter.
Soft candy, Sec. 1.2 Stabilizer and thickener,
170.3(n)(38) of this chapter. Sec. 170.3(o)(28) of this
chapter.
All other food categories.... .25 Flavoring agent, Sec.
170.3(o)(12) of this
chapter; formulation aid,
Sec. 170.3(o)(14) of this
chapter; humectant, Sec.
170.3(o)(16) of this
chapter; stabilizer,
thickener, Sec.
170.3(o)(28) of this
chapter.
------------------------------------------------------------------------
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[44 FR 19391, Apr. 3, 1979, as amended at 49 FR 5611, Feb. 14, 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: 21CFR184.1120]
[Page 482-483]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1120 Brown algae.
(a) Brown algae are seaweeds of the species Analipus japonicus,
Eisenia bicyclis, Hizikia fusiforme, Kjellmaniella gyrata, Laminaria
angustata, Laminaria claustonia, Laminaria digitata, Laminaria japonica,
Laminaria longicruris, Laminaria longissima, Laminaria ochotensis,
Laminaria saccharina, Macrocystis pyrifera, Petalonia fascia,
Scytosiphon lomentaria and Undaria pinnatifida. They are harvested
principally in coastal waters of the northern Atlantic and Pacific
oceans. The material is dried and ground or chopped for use in food.
(b) The ingredient meets the specifications for kelp in the Food
Chemicals Codex, 3d Ed. (1981), p. 157, which is incorporated by
reference. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or available for inspection
at the Office of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(2), the ingredient is used in
food only within the following specific limitations:
[[Page 483]]
------------------------------------------------------------------------
Maximum level of
Category of food use in food (as Functional use
served)
------------------------------------------------------------------------
Spices, seasonings, and Not to exceed Flavor enhancer,
flavorings, Sec. 170.3(n) (26) current good Sec. 170.3(o)(11
of this chapter. manufacturing ) of this
practice. chapter; flavor
adjuvant, Sec.
170.3(o)(12) of
this chapter.
------------------------------------------------------------------------
(d) Prior sanctions for this ingredient different from the use
established in this section do not exist or have been waived.
[47 FR 47376, Oct. 26, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1121]
[Page 483]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1121 Red algae.
(a) Red algae are seaweeds of the species Gloiopeltis furcata,
Porphyra crispata, Porphyra deutata, Porphyra perforata, Porphyra
suborbiculata, Porphyra tenera and Rhodymenia palmata. Porphyra and
Rhodymenia are harvested principally along the coasts of Japan, Korea,
China, Taiwan, and the East and West coasts of the United States.
Gloiopeltis is harvested principally in southern Pacific coastal waters.
The material is dried and ground or chopped for use in food.
(b) The ingredient meets the specifications for kelp in the Food
Chemicals Codex, 3d Ed. (1981), p. 157, which is incorporated by
reference, except that the loss on drying is not more than 20 percent
and the maximum allowable level for iodine is 0.05 percent. Copies are
available from the National Academy Press, 2101 Constitution Ave. NW.,
Washington, DC 20418, or available for inspection at the Office of the
Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
DC 20408.
(c) In accordance with Sec. 184.1(b)(2), the ingredient is used in
food only within the following specific limitations:
------------------------------------------------------------------------
Maximum level of
Category of food use in food (as Functional use
served)
------------------------------------------------------------------------
Spices, seasonings, and Not to exceed Flavor enhancer,
flavorings, Sec. 170.3(n) (26) current good Sec. 170.3(o)(11
of this chapter. manufacturing ) of this
practice. chapter; flavor
adjuvant, Sec.
170.3(o)(12) of
this chapter.
------------------------------------------------------------------------
(d) Prior sanctions for this ingredient different from the use
established in this section do not exist or have been waived.
[47 FR 47376, Oct. 26, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1133]
[Page 483]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1133 Ammonium alginate.
(a) Ammonium alginate (CAS Reg. No. 9005-34-9) is the ammonium salt
of alginic acid, a natural polyuronide constituent of certain brown
algae. Ammonium alginate is prepared by the neutralization of purified
alginic acid with appropriate pH control agents.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 18, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(2), the ingredient is used in
food only within the following specific limitations:
------------------------------------------------------------------------
Maximum
level of
use in
Category of food food (as Functional use
served)
(percent)
------------------------------------------------------------------------
Confections, frostings, Sec. 0.4 Stabilizer, thickener,
170.3(n)(9) of this chapter. Sec. 170.3(o)(28) of
this chapter.
Fats and oils, Sec. 170.3(n)(12) of 0.5 Do.
this chapter.
Gelatins, puddings, Sec. 0.5 Do.
170.3(n)(22) of this chapter.
Gravies and sauces, Sec. 0.4 Do.
170.3(n)(24) of this chapter.
Jams and jellies, Sec. 170.3(n)(28) 0.4 Do.
of this chapter.
Sweet sauces, Sec. 170.3(n)(43) of 0.5 Do.
this chapter.
All other food categories........... 0.1 Humectant, Sec.
170.3(o)(16) of this
chapter; stabilizer,
thickener, Sec.
170.3(o)(28) of this
chapter.
------------------------------------------------------------------------
(d) Prior sanctions for ammonium alginate different from the uses
established in this section do not exist or have been waived.
[47 FR 29950, July 9, 1982]
[[Page 484]]
[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: 21CFR184.1135]
[Page 484]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1135 Ammonium bicarbonate.
(a) Ammonium bicarbonate (NH4HCO3, CAS Reg.
No. 1066-33-7) is prepared by reacting gaseous carbon dioxide with
aqueous ammonia. Crystals of ammonium bicarbonate are precipitated from
solution and subsequently washed and dried.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 19, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a dough strengthener as defined in
Sec. 170.3(o)(6) of this chapter; a leavening agent as defined in
Sec. 170.3(o)(17) of this chapter; a pH control agent as defined in
Sec. 170.3(o)(23) of this chapter; and a texturizer as defined in
Sec. 170.3(o)(32) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52439, Nov. 18, 1983]
[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: 21CFR184.1137]
[Page 484]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1137 Ammonium carbonate.
(a) Ammonium carbonate ((NH4)2CO3,
CAS Reg. No. 8000-73-5) is a mixture of ammonium bicarbonate
(NH4HCO3) and ammonium carbamate
(NH2COONH4). It is prepared by the sublimation of
a mixture of ammonium sulfate and calcium carbonate and occurs as a
white powder or a hard, white or translucent mass.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 19, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a leavening agent as defined in
Sec. 170.3(o)(17) of this chapter and a pH control agent as defined in
Sec. 170.3(o)(23) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52439, Nov. 18, 1983]
[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: 21CFR184.1138]
[Page 484-485]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1138 Ammonium chloride.
(a) Ammonium chloride (NH4Cl, CAS Reg. No. 12125-02-9) is
produced by the reaction of sodium chloride and an ammonium salt in
solution. The less soluble sodium salt separates out at elevated
temperatures, and ammonium chloride is recovered from the filtrate on
cooling. Alternatively, hydrogen chloride formed by the burning of
hydrogen in chlorine is dissolved in water and then reacted with gaseous
ammonia. Ammonium chloride is crystallized from the solution.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 20, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave,
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon
[[Page 485]]
the following current good manufacturing practice conditions of use:
(1) The ingredient is used as a dough strengthener as defined in
Sec. 170.3(o)(6) of this chapter; a flavor enhancer as defined in
Sec. 170.3(o)(11) of this chapter; a leavening agent as defined in
Sec. 170.3(o)(17) of this chapter; and a processing aid as defined in
Sec. 107.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52439, Nov. 18, 1983]
[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: 21CFR184.1139]
[Page 485]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1139 Ammonium hydroxide.
(a) Ammonium hydroxide (NH4 OH, CAS Reg. No. 1336-21-6)
is produced by passing ammonia gas into water.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 20, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a leavening agent as defined in
Sec. 170.3(o)(17) of this chapter; a pH control agent as defined in
Sec. 170.3(o)(23) of this chapter; a surface-finishing agent as defined
in Sec. 170.3(o)(30) of this chapter; and as a boiler water additive
complying with Sec. 173.310 of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. The ingredient may also be used as a boiler
water additive at levels not to exceed current good manufacturing
practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52440, Nov. 18, 1983, as amended at 59 FR 14551, Mar. 29, 1994]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1140]
[Page 485]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1140 Ammonium citrate, dibasic.
(a) Ammonium citrate, dibasic
((NH4)2HC6H5O7,
CAS Reg. No. 3012-65-5) is the diammonium salt of citric acid. It is
prepared by partially neutralizing citric acid with ammonia.
(b) The Food and Drug Administration, in cooperation with the
National Academy of Sciences, is developing food-grade specifications
for ammonium citrate, dibasic. In the interim, this ingredient must be
of a purity suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a flavor enhancer as defined in
Sec. 170.3(o)(11) of this chapter and as a pH control agent as defined
in Sec. 170.3(o)(23) of this chapter.
(2) The ingredient is used in nonalcoholic beverages as defined in
Sec. 170.3(n)(3) of this chapter and in cheeses as defined in
Sec. 170.3(n)(5) of this chapter at levels not to exceed current good
manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section, or different from those set forth in part
181 of this chapter, do not exist or have been waived.
[59 FR 63896, Dec. 12, 1994]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1141a]
[Page 485-486]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1141a Ammonium phosphate, monobasic.
(a) Ammonium phosphate, monobasic
(NH4H2PO4, CAS Reg. No. 7722-76-1) is
manufactured by reacting ammonia with phosphoric acid at a pH below 5.8.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 21, which is incorporated by reference. Copies
are available from the National Academy Press,
[[Page 486]]
2101 Constitution Ave. NW., Washington, DC 20418, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a dough strengthener as defined in
Sec. 170.3(o)(6) of this chapter and a pH control agent as defined in
Sec. 170.3(o)(23) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52440, Nov. 18, 1983]
[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: 21CFR184.1141b]
[Page 486]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1141b Ammonium phosphate, dibasic.
(a) Ammonium phosphate, dibasic
((NH4)2HPO4, CAS Reg. No. 7783-28-0) is
manufactured by reacting ammonia with phosphoric acid at a pH above 5.8.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 21, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a dough strengthener as defined in
Sec. 170.3(o)(6) of this chapter; a firming agent as defined in
Sec. 170.3(o)(10) of this chapter; a leavening agent as defined in
Sec. 170.3(o)(17) of this chapter; a pH control agent as defined in
Sec. 170.3(o)(23) of this chapter; and a processing aid as defined in
Sec. 170.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52440, Nov. 18, 1983]
[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: 21CFR184.1143]
[Page 486]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1143 Ammonium sulfate.
(a) Ammonium sulfate ((NH4)2SO4,
CAS Reg. No. 7783-20-2) occurs naturally and consists of colorless or
white, odorless crystals or granules. It is prepared by the
neutralization of sulfuric acid with ammonium hydroxide.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), pp. 22-23, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as a dough strengthener as defined in
Sec. 170.3(o)(6) of this chapter, firming agent as defined in
Sec. 170.3(o)(10) of this chapter, and processing aid as defined in
Sec. 170.3(o)(24) of this chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practice in accordance with Sec. 184.1(b)(1). Current good
manufacturing practice results in a maximum level, as served, of 0.15
percent for baked goods as defined in Sec. 170.3(n)(1) of this chapter
and 0.1 percent for gelatins and puddings as defined in
Sec. 170.1(n)(22) of this chapter.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[45 FR 6086, Jan. 25, 1980; 45 FR 16469, Mar. 14, 1980, as amended at 49
FR 5611, Feb. 14, 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: 21CFR184.1148]
[Page 486-487]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1148 Bacterially-derived carbohydrase enzyme preparation.
(a) Bacterially-derived carbohydrase enzyme preparation is obtained
from the culture filtrate resulting from a
[[Page 487]]
pure culture fermentation of a nonpathogenic and nontoxigenic strain of
Bacillus subtilis or B. amyloliquefaciens. The preparation is
characterized by the presence of the enzymes [alpha]-amylase (EC
3.2.1.1) and [beta]-glucanase (EC 3.2.1.6), which catalyze the
hydrolysis of O-glycosyl bonds in carbohydrates.
(b) The ingredient meets the general requirements and additional
requirements in the monograph on enzyme preparations in the Food
Chemicals Codex, 4th ed. (1996), pp. 128-135, which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or may be examined at the Center for Food
Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College
Park, MD 20740, or at the Office of the Federal Register, 800 North
Capitol Street, NW., Suite 700, Washington, DC. In addition, antibiotic
activity is absent in the enzyme preparation when determined by an
appropriate validated method such as the method "Determination of
antibiotic activity" in the Compendium of Food Additive Specifications,
vol. 2, Joint FAO/WHO Expert Committee on Food Additives (JECFA), Food
and Agriculture Organization of the United Nations, Rome, 1992. Copies
are available from Bernan Associates, 4611-F Assembly Dr., Lanham, MD
20706, or from The United Nations Bookshop, General Assembly Bldg., rm.
32, New York, NY 10017, or by inquiries sent to "http://www.fao.org".
Copies may be examined at the Center for Food Safety and Applied
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as GRAS as a direct food ingredient
is based upon the following current good manufacturing practice
conditions of use:
(1) The ingredient is used as an enzyme as defined in
Sec. 170.3(o)(9) of this chapter to hydrolyze polysaccharides (e.g.,
starch).
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
[64 FR 19894, Apr. 23, 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: 21CFR184.1150]
[Page 487-488]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1150 Bacterially-derived protease enzyme preparation.
(a) Bacterially-derived protease enzyme preparation is obtained from
the culture filtrate resulting from a pure culture fermentation of a
nonpathogenic and nontoxigenic strain of Bacillus subtilis or B.
amyloliquefaciens. The preparation is characterized by the presence of
the enzymes subtilisin (EC 3.4.21.62) and neutral proteinase (EC
3.4.24.28), which catalyze the hydrolysis of peptide bonds in proteins.
(b) The ingredient meets the general requirements and additional
requirements in the monograph on enzyme preparations in the Food
Chemicals Codex, 4th ed. (1996), pp. 128-135, which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or may be examined at the Center for Food
Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College
Park, MD 20740, or at the Office of the Federal Register, 800 North
Capitol Street, NW., Suite 700 Washington, DC. In addition, antibiotic
activity is absent in the enzyme preparation when determined by an
appropriate validated method such as the method "Determination of
antibiotic activity" in the Compendium of Food Additive Specifications,
vol. 2, Joint FAO/WHO Expert Committee on Food Additives (JECFA), Food
and Agriculture Organization of the United Nations, Rome, 1992. Copies
are available from Bernan Associates, 4611-F Assembly Dr., Lanham, MD
20706, or from The United Nations Bookshop, General Assembly Bldg., rm.
32, New York, NY 10017, or by inquiries sent to "http://www.fao.org".
Copies may be examined at the Center for Food Safety and Applied
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good
[[Page 488]]
manufacturing practice. The affirmation of this ingredient as GRAS as a
direct food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an enzyme as defined in
Sec. 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
[64 FR 19895, Apr. 23, 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: 21CFR184.1155]
[Page 488]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1155 Bentonite.
(a) Bentonite
(Al2O34SiO2nH2O, CAS Reg.
No. 1302-0978-099) is principally a colloidal hydrated aluminum
silicate. Bentonite contains varying quantities of iron, alkalies, and
alkaline earths in the commercial products. Depending on the cations
present, natural deposits of bentonite range in color from white to
gray, yellow, green, or blue. Bentonite's fine particles provide large
total surface area and, hence, pronounced adsorptive capability.
(b) FDA is developing food-grade specifications for bentonite in
cooperation with the National Academy of Sciences. In the interim, the
ingredient must be of a suitable purity for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a processing aid as defined in
Sec. 170.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Current good manufacturing practice results
in no significant residue in foods.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[47 FR 43367, Oct. 1, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1157]
[Page 488]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1157 Benzoyl peroxide.
(a) Benzoyl peroxide
((C6H5CO)2O2, CAS Reg. No.
94-36-0) is a colorless, rhombic crystalline solid. It is prepared by
reaction of benzoyl chloride, sodium hydroxide, and hydrogen peroxide.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 35, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a bleaching agent in food.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: flour; milk used for
production of Asiago fresh and Asiago soft cheese (Sec. 133.102), Asiago
medium cheese (Sec. 133.103), Asiago old cheese (Sec. 133.104), Blue
cheese (Sec. 133.106), Caciocavallo siciliano chesse (Sec. 133.111),
Gorgonzola cheese (Sec. 133.141), Parmesan and reggiano cheese
(Sec. 133.165), Provolone cheese (Sec. 133.181), Romano cheese
(Sec. 133.183), and Swiss and emmentaler cheese (Sec. 133.195) in part
133 of this chapter; and annatto-colored whey, such that the final
bleached product conforms to the descriptions and specifications for
whey, concentrated whey, or dried whey in Sec. 184.1979(a) (1), (2), or
(3), respectively.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[51 FR 27173, July 30, 1986]
[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: 21CFR184.1165]
[Page 488-489]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1165 n-Butane and iso-butane.
(a) n-Butane and iso-butane (empirical formula
C4H10, CAS Reg. Nos. 106-
[[Page 489]]
97-8 and 75-28-5, respectively) are colorless, odorless, flammable gases
at normal temperatures and pressures. They are easily liquefied under
pressure at room temperature and are stored and shipped in the liquid
state. The butanes are obtained from natural gas by fractionation
following absorption in oil, adsorption to surface-active agents, or
refrigeration.
(b) The Food and Drug Administration is developing food-grade
specifications for n-butane and iso-butane in cooperation with the
National Academy of Sciences. In the interim, the ingredients must be of
a purity suitable for their intended use.
(c) In accordance with Sec. 184.1(b)(1), these ingredients are used
in food with no limitations other than current good manufacturing
practice. The affirmation of these ingredients as generally recognized
as safe (GRAS) as direct human food ingredients is based upon the
following current good manufacturing practice conditions of use:
(1) The ingredients are used as propellants, aerating agents, and
gases as defined in Sec. 170.3(o)(25) of this chapter.
(2) The ingredients are used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
[48 FR 57270, Dec. 29, 1983]
[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: 21CFR184.1185]
[Page 489]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1185 Calcium acetate.
(a) Calcium acetate (Ca
(C2H3O2)2, CAS Reg. No. 62-
54-4), also known as acetate of lime or vinegar salts, is the calcium
salt of acetic acid. It may be produced by the calcium hydroxide
neutralization of acetic acid.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 44, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) The ingredient is used as a firming agent as defined in
Sec. 170.3(o)(10) of this chapter; pH control agent as defined in
Sec. 170.3(o)(23) of this chapter; processing aid as defined in
Sec. 170.3(o)(24) of this chapter; sequestrant as defined in
Sec. 170.3(o)(26) of this chapter; stabilizer and thickener as defined
in Sec. 170.3(o)(28) of this chapter; and texturizer as defined in
Sec. 170.3(o)(32) of this chapter.
(d) The ingredient is used in food at levels not to exceed current
good manufacturing practices in accordance with Sec. 184.1(b)(1).
Current good manufacturing practices result in a maximum level, as
served, of 0.2 percent for baked goods as defined in Sec. 170.3(n)(1) of
this chapter; 0.02 percent for cheese as defined in Sec. 170.3(n)(5) of
this chapter; 0.2 percent for gelatins, puddings, and fillings as
defined in Sec. 170.3(n)(22) of this chapter; 0.15 percent for sweet
sauces, toppings, and syrups as defined in Sec. 170.3(n)(43) of this
chapter; and 0.0001 percent for all other food categories.
(e) Prior sanctions for this ingredient different from the uses
established in this section or in part 181 of this chapter do not exist
or have been waived.
[47 FR 27807, June 25, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1187]
[Page 489-490]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1187 Calcium alginate.
(a) Calcium alginate (CAS Reg. No. 9005-35-0) is the calcium salt of
alginic acid, a natural polyuronide constituent of certain brown algae.
Calcium alginate is prepared by the neutralization of purified alginic
acid with appropriate pH control agents, or from sodium alginate by
metathesis with appropriate calcium salts.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 45, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(2), the ingredient is used in
food only within the following specific limitations:
[[Page 490]]
------------------------------------------------------------------------
Maximum
level of
use in
Category of food food (as Functional use
served)
(percent)
------------------------------------------------------------------------
Baked goods, Sec. 170.3(n)(1) of 0.002 Stabilizer, thickener,
this chapter. Sec. 170.3(o)(28) of
this chapter.
Alcoholic beverages, Sec. 0.4 Do.
170.3(n)(2) of this chapter.
Confections and frostings, Sec. 0.4 Do.
170.3(n)(9) of this chapter.
Egg products, Sec. 170.3(n)(11) of 0.6 Do.
this chapter.
Fats and oils, Sec. 170.3(n)(12) of 0.5 Do.
this chapter.
Gelatins, puddings, Sec. 0.25 Do.
170.3(n)(22) of this chapter.
Gravies and sauces, Sec. 0.4 Do.
170.3(n)(24) of this chapter.
Jams and jellies, Sec. 170.3(n)(28) 0.5 Do.
of this chapter.
Sweet sauces, Sec. 170.3(n)(43) of 0.5 Do.
this chapter.
All other food categories........... 0.3 Do.
------------------------------------------------------------------------
(d) Prior sanctions for calcium alginate different from the uses
established in this section do not exist or have been waived.
[47 FR 29951, July 9, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1191]
[Page 490]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1191 Calcium carbonate.
(a) Calcium carbonate (CaCO3, CAS Reg. No. 471-34-1) is
prepared by three common methods of manufacture:
(1) As a byproduct in the "Lime soda process";
(2) By precipitation of calcium carbonate from calcium hydroxide in
the "Carbonation process"; or
(3) By precipitation of calcium carbonate from calcium chloride in
the "Calcium chloride process".
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 46, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section, or different from that set forth in part
181 of this chapter, do not exist or have been waived.
[48 FR 52441, Nov. 18, 1983]
[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: 21CFR184.1193]
[Page 490-491]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1193 Calcium chloride.
(a) Calcium chloride (CaCl2[middot]2H2O, CAS
Reg. No. 10035-04-8) or anhydrous calcium chloride (CaCl2,
CAS Reg. No. 10043-52-4) may be commercially obtained as a byproduct in
the ammonia-soda (Solvay) process and as a joint product from natural
salt brines, or it may be prepared by substitution reactions with other
calcium and chloride salts.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 47, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) The ingredient is used as an anticaking agent as defined in
Sec. 170.3(o)(1) of this chapter; antimicrobial agent as defined in
Sec. 170.3(o)(2) of this chapter; curing or pickling agent as defined in
Sec. 170.3(o)(5) of this chapter; firming agent as defined in
Sec. 170.3(o)(10) of this chapter; flavor enhancer as defined in
Sec. 170.3(o)(11) of this chapter; humectant as defined in
Sec. 170.3(o)(16) of this chapter; nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter; pH control agent as defined in
Sec. 170.3(o)(23) of this chapter; processing aid as defined in
Sec. 170.3(o)(24) of this chapter; stabilizer and thickener as defined
in Sec. 170.3(o)(28) of this chapter; surface-active agent as defined in
Sec. 170.3(o)(29) of this chapter; synergist as defined in
Sec. 170.3(o)(31) of this chapter; and texturizer as defined in
Sec. 170.3(o)(32) of this chapter.
(d) The ingredient is used in foods at levels not to exceed current
good manufacturing practices in accordance
[[Page 491]]
with Sec. 184.1(b)(1). Current good manufacturing practices result in a
maximum level, as served, of 0.3 percent for baked goods as defined in
Sec. 170.3(n)(1) of this chapter and for dairy product analogs as
defined in Sec. 170.3(n)(10) of this chapter; 0.22 percent for
nonalcoholic beverages and beverage bases as defined in Sec. 170.3(n)(3)
of this chapter; 0.2 percent for cheese as defined in Sec. 170.3(n)(5)
of this chapter and for processed fruit and fruit juices as defined in
Sec. 170.3(n)(35) of this chapter; 0.32 percent for coffee and tea as
defined in Sec. 170.3(n)(7) of this chapter; 0.4 percent for condiments
and relishes as defined in Sec. 170.3(n)(8) of this chapter; 0.2 percent
for gravies and sauces as defined in Sec. 170.3(n)(24) of this chapter;
0.1 percent for commercial jams and jellies as defined in
Sec. 170.3(n)(28) of this chapter; 0.25 percent for meat products as
defined in Sec. 170.3(n)(29) of this chapter; 2.0 percent for plant
protein products as defined in Sec. 170.3(n)(33) of this chapter; 0.4
percent for processed vegetables and vegetable juices as defined in
Sec. 170.3(n)(36) of this chapter; and 0.05 percent for all other food
categories.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[47 FR 27808, June 25, 1982, as amended at 61 FR 14247, 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: 21CFR184.1195]
[Page 491]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1195 Calcium citrate.
(a) Calcium citrate
(Ca3(C6H5O7)2[midd
ot]4H2O, CAS Reg. No. 813-0994-095) is the calcium salt of
citric acid. It is prepared by neutralizing citric acid with calcium
hydroxide or calcium carbonate. It occurs as a fine white, odorless
powder and usually contains four moles of water per mole of calcium
citrate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d ed. (1981), pp. 49 and 50, which is incorporated by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are
available from the National Academy Press, 2101 Constitution Ave. NW.,
Washington, DC 20418, and the Center for Food Safety and Applied
Nutrition (HFS-200), 5100 Paint Branch Pkwy., College Park, MD 20740, or
may be examined at the Office of the Federal Register, 800 North Capitol
St. NW., suite 700, Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
Calcium citrate may also be used in infant formula in accordance with
section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or
with regulations promulgated under section 412(a)(2) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[59 FR 63896, Dec. 12, 1994]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1199]
[Page 491-492]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1199 Calcium gluconate.
(a) Calcium gluconate
([CH2OH(CHOH)4COO]2Ca, CAS Reg. No.
299-28-5) is the calcium salt of gluconic acid which may be produced by
neutralization of gluconic acid with lime or calcium carbonate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 51, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) The ingredient is used as a firming agent as defined in
Sec. 170.3(o)(10) of this chapter; formulation aid as defined in
Sec. 170.3(o)(14) of this chapter; sequestrant as defined in
Sec. 170.3(o)(26) of this chapter; stabilizer or thickener as defined in
Sec. 170.3(o)(28) of this chapter; and texturizer as defined in
Sec. 170.3(o)(32) of this chapter.
(d) The ingredient is used in foods at levels not to exceed current
good manufacturing practices in accordance with Sec. 184.1(b)(1).
Current good manufacturing practices result in a maximum level, as
served, of 1.75 percent for baked goods as defined in Sec. 170.3(n)(1)
of this chapter; 0.4 percent for dairy product analogs as defined in
Sec. 170.3(n)(10) of this chapter; 4.5 percent for gelatins and puddings
as defined in Sec. 170.3(n)(22) of this chapter; and 0.01 percent for
sugar substitutes as defined in Sec. 170.3(n)(42) of this chapter.
(e) Prior sanctions for this ingredient different from the uses
established in
[[Page 492]]
this section do not exist or have been waived.
[47 FR 27808, June 25, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1201]
[Page 492]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1201 Calcium glycerophosphate.
(a) Calcium glycerophosphate
(C3H7CaO6P, CAS Reg. No. 27214-00-2) is
a fine, white, odorless, almost tasteless, slightly hygroscopic powder.
It is prepared by neutralizing glycerophosphoric acid with calcium
hydroxide or calcium carbonate. The commercial product is a mixture of
calcium [beta]-, and D-, and L-[alpha]-glycerophosphate.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), pp. 51-52, which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 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.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in gelatins, puddings, and fillings as
defined in Sec. 170.3(n)(22) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section or different from that as set forth in part
181 of this chapter, do not exist or have been waived.
[57 FR 10813, Mar. 31, 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: 21CFR184.1205]
[Page 492]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1205 Calcium hydroxide.
(a) Calcium hydroxide (Ca(OH)2, CAS Reg. No. 1305-62-0)
is also known as slaked lime or calcium hydrate. It is produced by the
hydration of lime.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 52, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[49 FR 26714, June 29, 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: 21CFR184.1206]
[Page 492]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1206 Calcium iodate.
(a) Calcium iodate
[Ca(IO3)2[middot]H2O, CAS Reg. No.
7789-80-2], also referred to as lautarite, does not occur naturally but
can be prepared by passing chlorine into a hot solution of lime
(CaCO3) in which iodine has been dissolved.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), p. 53, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as a dough strengthener as defined in
Sec. 170.3(o)(6) of this chapter.
(d) The ingredient is used in the manufacture of bread in accordance
with Sec. 184.1(b)(2) of this chapter in an amount not to exceed 0.0075
percent based on the weight of the flour.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[43 FR 11699, Mar. 21, 1978, as amended at 49 FR 5611, Feb. 14, 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: 21CFR184.1207]
[Page 492-493]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1207 Calcium lactate.
(a) Calcium lactate
(C6H10CaO6.xH2O, where x is
any integer up to 5, CAS Reg. No. 814-80-2) is prepared commercially by
the neutralization of lactic acid with calcium carbonate or calcium
hydroxide.
(b) The ingredient meets the specifications of the Food Chemicals
Codex,
[[Page 493]]
3d Ed. (1981), p. 53, which is incorporated by reference. Copies are
available from the National Academy Press, 2101 Constitution Avenue NW.,
Washington, DC 20418, or available for inspection at the Office of the
Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a firming agent as defined in
Sec. 170.3(o)(10) of this chapter; a flavor enhancer as defined in
Sec. 170.3(o)(11) of this chapter; a flavoring agent or adjuvant as
defined in Sec. 170.3(o)(12) of this chapter; a leavening agent as
defined in Sec. 170.3(o)(17) of this chapter; a nutrient supplement as
defined in Sec. 170.3(o)(20) of this chapter; and a stabilizer and
thickener as defined in Sec. 170.3(o)(28) of this chapter.
(2) The ingredient is used in food, except in infant foods and
infant formulas, at levels not to exceed current good manufacturing
practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[49 FR 35367, Sept. 7, 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: 21CFR184.1210]
[Page 493]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1210 Calcium oxide.
(a) Calcium oxide (CaO, CAS Reg. No. 1305-78-8) is also known as
lime, quick lime, burnt lime, or calx. It is produced from calcium
carbonate, limestone, or oyster shells by calcination at temperatures of
1,700-2,450 deg.F.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 55, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[49 FR 26714, June 29, 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: 21CFR184.1212]
[Page 493]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1212 Calcium pantothenate.
(a) Calcium pantothenate
((C9H16NO5)2Ca, CAS Reg. No.
of the D-isomer, 137-08-6) is a salt of pantothenic acid, one of the
vitamins of the B complex. Only the D-isomer of pantothenic acid has
vitamin activity, although both the D-isomer and the DL-racemic mixture
of calcium pantothenate are used in food. Commercial calcium
pantothenate is prepared synthetically from isobutyraldehyde and
formaldehyde via 1,1-dimethyl-2-hydroxy-propionaldehyde and
pantolactone.
(b) Calcium pantothenate meets the specifications of the Food
Chemicals Codex, 3d Ed. (1981), p. 56, which is incorporated by
reference. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or available for inspection
at the Office of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice. Calcium pantothenate may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 51908, Nov. 15, 1983]
[[Page 494]]
[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: 21CFR184.1221]
[Page 494]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1221 Calcium propionate.
(a) Calcium propionate (C6H10CaO4,
CAS Reg. No. 4075-81-4) is the calcium salt of propionic acid. It occurs
as white crystals or a crystalline solid, possessing not more than a
faint odor of propionic acid. It is prepared by neutralizing propionic
acid with calcium hydroxide.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 60, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as an antimicrobial agent as defined in
Sec. 170.3(o)(2) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods as defined in
Sec. 170.3(n)(1) of this chapter; cheeses as defined in Sec. 170.3(n)(5)
of this chapter; confections and frostings as defined in
Sec. 170.3(n)(9) of this chapter; gelatins, puddings, and fillings as
defined in Sec. 170.3(n)(22) of this chapter; and jams and jellies as
defined in Sec. 170.3(n)(28) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[49 FR 13141, Apr. 3, 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: 21CFR184.1229]
[Page 494]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1229 Calcium stearate.
(a) Calcium stearate
(Ca(C17H35COO)2, CAS Reg. No. 1529-23-
0) is the calcium salt of stearic acid derived from edible sources. It
is prepared as a white precipitate by mixing calcium chloride and sodium
stearate in aqueous solution.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 64, which is incorporated by reference, and the
requirements of Sec. 172.860(b)(2) of this chapter. Copies of the Food
Chemicals Codex are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or available for inspection
at the Office of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter; a lubricant and release
agent as defined in Sec. 170.3(o)(18) of this chapter; and a stabilizer
and thickener as defined in Sec. 170.3(o)(28) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52445, Nov. 18, 1983]
[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: 21CFR184.1230]
[Page 494-495]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1230 Calcium sulfate.
(a) Calcium sulfate (CaSO4, CAS Reg. No. 7778-18-9 or
CaSO4[middot]2H2O, CAS Reg. No. 10101-41-4), also
known as plaster of Paris, anhydrite, and gypsum, occurs naturally and
exists as a fine, white to slightly yellow-white odorless powder. The
anhydrous form is prepared by complete dehydration of gypsum, below 300
deg.C, in an electric oven.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), p. 66, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as an anticaking agent as defined in
Sec. 170.3(o)(1) of this chapter, color and coloring adjunct as defined
in
[[Page 495]]
Sec. 170.3(o)(4) of this chapter, dough strengthener as defined in
Sec. 170.3(o)(6) of this chapter, drying agent as defined in
Sec. 170.3(o)(7) of this chapter, firming agent as defined in
Sec. 170.3(o)(10) of this chapter, flour treating agent as defined in
Sec. 170.3(o)(13) of this chapter, formulation aid as defined in
Sec. 170.3(o)(14) of this chapter, leavening agent as defined in
Sec. 170.3(o)(17) of this chapter, nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter, pH control agent as defined in
Sec. 170.3(o)(23) of this chapter, processing aid as defined in
Sec. 170.3(o)(24) of this chapter, stabilizer and thickener as defined
in Sec. 170.3(o)(28) of this chapter, synergist as defined in
Sec. 170.3(o)(31) of this chapter, and texturizer as defined in
Sec. 170.3(o)(32) of this chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practice in accordance with Sec. 184.1(b)(1). Current good
manufacturing practice results in a maximum level, as served, of 1.3
percent for baked goods as defined in Sec. 170.3(n)(1) of this chapter,
3.0 percent for confections and frostings as defined in Sec. 170.3(n)(9)
of this chapter, 0.5 percent for frozen dairy desserts and mixes as
defined in Sec. 170.3(n)(20) of this chapter, 0.4 percent for gelatins
and puddings as defined in Sec. 170.3(n)(22) of this chapter, 0.5
percent for grain products and pastas as defined in Sec. 170.3(n)(23) of
this chapter, 0.35 percent for processed vegetables as defined in
Sec. 170.3(n)(36) of this chapter, and 0.07 percent or less for all
other food categories.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[45 FR 6086, Jan. 25, 1980; 45 FR 26319, Apr. 18, 1980, as amended at 49
FR 5611, Feb. 14, 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: 21CFR184.1240]
[Page 495]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1240 Carbon dioxide.
(a) Carbon dioxide (empirical formula CO2, CAS Reg. No.
124-38-9) occurs as a colorless, odorless, noncombustible gas at normal
temperatures and pressures. The solid form, dry ice, sublimes under
atmospheric pressure at a temperature of -78.5 deg.C. Carbon dioxide is
prepared as a byproduct of the manufacture of lime during the
"burning" of limestone, from the combustion of carbonaceous material,
from fermentation processes, and from gases found in certain natural
springs and wells.
(b) The Food and Drug Administration is developing food-grade
specifications for carbon dioxide in cooperation with the National
Academy of Sciences. In the interim, the ingredient must be of purity
suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitations other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a leavening agent as defined in
Sec. 170.3(o)(17) of this chapter; a processing aid as defined in
Sec. 170.3(o)(24) of this chapter; and a propellant, aerating agent, and
gas as defined in Sec. 170.3(o)(25) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 57270, Dec. 29, 1983]
[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: 21CFR184.1245]
[Page 495-496]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1245 Beta-carotene.
(a) Beta-carotene (CAS Reg. No. 7235-40-7) has the molecular formula
C40H56. It is synthesized by saponification of
vitamin A acetate. The resulting alcohol is either reacted to form
vitamin A Wittig reagent or oxidized to vitamin A aldehyde. Vitamin A
Wittig reagent and vitamin A aldehyde are reacted together to form beta-
carotene.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 73, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washingtion, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good
[[Page 496]]
manufacturing practice. The affirmation of this ingredient as generally
recognized as safe (GRAS) as a direct human food ingredient is based
upon the following current good manufacturing practice conditions of
use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: dairy product analogs as
defined in Sec. 170.3(n)(10) of this chapter; fats and oils as defined
in Sec. 170.3(n)(12) of this chapter; and processed fruits and fruit
juices as defined in Sec. 170.3(n)(35) of this chapter. Beta-carotene
may be used in infant formula as a source of vitamin A in accordance
with section 412(g) of the Federal Food, Drug, and Cosmetic Act or with
regulations promulgated under section 412(g) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[52 FR 25211, July 6, 1987]
[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: 21CFR184.1250]
[Page 496]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1250 Cellulase enzyme preparation derived from Trichoderma longibrachiatum.
(a) Cellulase enzyme preparation is derived from a nonpathogenic,
nontoxicogenic strain of Trichoderma longibrachiatum (formerly T.
reesei). The enzyme, cellulase, catalyzes the endohydrolysis of 1,4-
beta-glycosidic linkages in cellulose. It is obtained from the culture
filtrate resulting from a pure culture fermentation process.
(b) The ingredient meets the general and additional requirements for
enzyme preparations in the monograph specifications on enzyme
preparations in the "Food Chemicals Codex," 4th ed. (1996), pp. 129 to
134, which is incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies are available from the National Academy
Press, 2101 Constitution Ave. NW., Box 285, Washington, DC 20055
(Internet "http://www.nap.edu"), or may be examined at the Center for
Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy.,
College Park, MD 20740, or at the Office of the Federal Register, 800
North Capitol St. NW., suite 700, Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used in food as an enzyme as defined in
Sec. 170.3(o)(9) of this chapter for the breakdown of cellulose.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
[64 FR 28361, May 26, 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: 21CFR184.1257]
[Page 496-497]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1257 Clove and its derivatives.
(a) Cloves are the dried unopened flower buds and calyx tubes,
harvested before the flowers have opened, of the clove tree Eugenia
caryophyllata Thunberg, native to tropical Asia. Their derivatives
include essential oils (cloves, CAS Reg. No. 8000-34-8; buds; leaves,
CAS Reg. No. 8015-97-2; stems, CAS Reg. No. 8015-98-3; and eugenol, CAS
Reg. No. 97-53-0), oleoresins, and natural extractives obtained from
clove buds, leaves, and stems.
(b) Clove bud oil, clove leaf oil, clove stem oil, and eugenol meet
the specifications of the "Food Chemicals Codex," 4th ed. (1996), pp.
104-105, 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. As determined by analytical methods in the "Food
Chemicals Codex," clove oleoresin or other natural extractives (other
than clove oils) meet the "Food Chemicals Codex" specifications for
clove (clove bud) oil and the following modifications:
(1) The assay for phenols, as eugenol, by the "Food Chemicals
Codex" test, 4th ed. (pp. 104-105), or the volatile oils content by the
"Food Chemicals
[[Page 497]]
Codex" test, 4th ed. (pp. 104-105) should conform to the representation
of the vendor;
(2) Optical rotation of the volatile oil between -2 deg. and 0 deg.;
(3) Refractive index of the volatile oil between 1.527 and 1.538 at
20 deg.C;
(4) Specific gravity of the volatile oil between 1.036 and 1.060;
and
(5) Residual solvent free, except those solvents that are GRAS or
within tolerance levels as specified in part 173, subpart C, of this
chapter.
(c) Clove and its derivatives are used as flavoring agents and
adjuvants as defined in Sec. 170.3(0)(12) of this chapter.
(d) The ingredients are used in food at levels not to exceed good
manufacturing practice in accordance with Sec. 184.1(b)(1).
(e) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
[44 FR 3964, Jan 19, 1979, as amended at 47 FR 11852, Mar. 19, 1982; 49
FR 5611, Feb. 14, 1984; 64 FR 1759, Jan. 12, 1999]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1259]
[Page 497-498]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1259 Cocoa butter substitute.
(a) The common or usual name for the triglyceride 1-palmitoyl-2-
oleoyl-3-stearin is "cocoa butter substitute primarily from palm oil."
The common or usual name for the triglyceride 1-3-distearoyl-2-olein is
"cocoa butter substitute primarily from high-oleic safflower or
sunflower oil."
(1) The ingredient 1-palmitoyl-2-oleoyl-3-stearin is manufactured
by:
(i) Directed esterification of fully saturated 1,3-diglycerides
(derived from palm oil) with the anhydride of food-grade oleic acid in
the presence of the catalyst trifluoromethane sulfonic acid
(Sec. 173.395 of this chapter), or
(ii) By interesterification of partially saturated 1,2,3-
triglycerides (derived from palm oil) with ethyl stearate in the
presence of a suitable lipase enzyme preparation that is either
generally recognized as safe (GRAS) or has food additive approval for
such use.
(2) The ingredient 1-3-distearoyl-2-olein is manufactured by
interesterification of partially unsaturated 1,2,3-triglycerides
(derived from high-oleic safflower or sunflower oil) with ethyl stearate
or stearic acid in the presence of a suitable lipase enzyme preparation
that is either GRAS or has food additive approval for such use.
(b) The ingredient meets the following specifications:
(1) Over 90 percent triglycerides, not more than 7 percent
diglycerides, not more than 1 percent monoglycerides, and not more than
1 percent free fatty acids.
(2) Total glycerides--98 percent minimum.
(3) Heavy metals (as lead), not more than 10 milligrams per
kilogram, as determined by the Heavy Metals Test of the "Food Chemicals
Codex," 4th ed. (1996), pp. 760-761, 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.
(4) Color--clear, bright, and free from suspended matter.
(5) Odor and taste--free from foreign and rancid odor and taste.
(6) Residual catalyst ("Official Methods of Analysis of the
Association of Official Analytical Chemists," 13th Ed. (1980), sections
25.049-25.055, which is incorporated by reference), residual fluorine;
limit of detection 0.2 part per million F; multiply fluoride result by
2.63 to convert to residual catalyst. Copies of the material
incorporated by reference may be obtained from the Association of
Official Analytical Chemists, P.O. Box 540, Benjamin Franklin Station,
Washington, DC 20044, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408. The ingredient shall be washed three times in batches with 0.5
percent sodium bicarbonate to remove catalyst residuals in accordance
with good manufacturing practice.
(7) Residual methanol--5 parts per million maximum.
(8) Residual fatty acid ethyl esters--not more than 20 parts per
million as
[[Page 498]]
determined by a "Modification of Japan Institute of Oils and Fats:
Analysis Method of Residual Ethyl Esters of Fatty Acids" issued by the
Fuji Oil Co., which is incorporated by reference. Copies are available
from the Division of Food and Color Additives, 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.
(9) Hexane--not more than 5 parts per million as determined by the
method of Dupuy et al., "Rapid Quantitative Determination of Residual
Hexane in Oils by Direct Gas Chromatography," published in the
"Journal of the American Oil Chemists' Society," Vol. 52, p. 118-120,
1975, which is incorporated by reference. Copies are available from the
Division of Food and Color Additives, Center for Food Safety and Applied
Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or available for inspection at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
the following food categories at levels not to exceed current good
manufacturing practice: Confections and frostings as defined in
Sec. 170.3(n)(9) of this chapter; coatings of soft candy as defined in
Sec. 170.3(n)(38) of this chapter; and sweet sauces and toppings as
defined in Sec. 170.3(n)(43) of this chapter; except that the ingredient
may not be used in a standardized food unless permitted by the standard
of identity.
(d) The ingredient is used in food in accordance with
Sec. 184.1(b)(1) at levels not to exceed good manufacturing practice.
[43 FR 54239, Nov. 11, 1978, as amended at 47 FR 11852, Mar. 19, 1982;
49 FR 5611, Feb. 14, 1984; 49 FR 22799, June 1, 1984; 52 FR 47920, Dec.
17, 1987; 52 FR 48905, Dec. 28, 1987; 61 FR 36290, July 10, 1996; 64 FR
1760, 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: 21CFR184.1260]
[Page 498]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1260 Copper gluconate.
(a) Copper gluconate (cupric gluconate
(CH2OH(CHOH)4COO)2Cu, CAS Reg. No. 527-
09-3) is a substance that occurs as light blue to bluish-green, odorless
crystals, or as a fine, light blue powder. It is prepared by the
reaction of gluconic acid solutions with cupric oxide or basic cupric
carbonate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 90, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC. 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC. 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter and as a synergist as defined in
Sec. 170.3(o)(31) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Copper gluconate may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the Act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[49 FR 24119, June 12, 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: 21CFR184.1261]
[Page 498-499]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1261 Copper sulfate.
(a) Copper sulfate (cupric sulfate,
CuSO4[middot]5H2O, CAS Reg. No. 7758-98-7) usually
is used in the pentahydrate form. This form occurs as large, deep blue
or ultramarine, triclinic crystals; as blue granules, or as a light blue
powder. The ingredient is prepared by the reaction of sulfuric acid with
cupric oxide or with copper metal.
(b) FDA is developing food-grade specifications for copper sulfate
in cooperation with the National Academy of Sciences. In the interim,
this ingredient must be of a purity suitable for its intended use.
[[Page 499]]
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter and as a processing aid as defined in
Sec. 170.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Copper sulfate may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the Act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[49 FR 24119, June 12, 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: 21CFR184.1262]
[Page 499]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1262 Corn silk and corn silk extract.
(a) Corn silk is the fresh styles and stigmas of Zea mays L.
collected when the corn is in milk. The filaments are extracted with
dilute ethanol to produce corn silk extract. The extract may be
concentrated at a temperature not exceeding 60 deg.C.
(b) The Food and Drug Administration, in cooperation with the
National Academy of Sciences, is developing food-grade specifications
for corn silk and corn silk extract. In the interim, this ingredient
must be of a suitable purity for its intended use.
(c) In accordance with Sec. 184.1(b)(2), the ingredients are used in
food only within the following specific limitations:
------------------------------------------------------------------------
Maximum
level of
Category of food use in Functional use
food (as
served)\1\
------------------------------------------------------------------------
Baked goods and baking mixes, Sec. 30 Flavoring agent, Sec.
170.3(n)(1) of this chapter. 170.3(o)(12) of this
chapter.
Nonalcoholic beverages, Sec. 20 Do.
170.3(n)(3) of this chapter.
Frozen dairy desserts, Sec. 10 Do.
170.3(n)(20) of this chapter.
Soft candy, Sec. 170.3(n)(38) of 20 Do.
this chapter.
All other food categories........... 4 Do.
------------------------------------------------------------------------
\1\ Parts per million.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[47 FR 29953, July 9, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1265]
[Page 499]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1265 Cuprous iodide.
(a) Cuprous iodide (copper (I) iodide, CuI, CAS Reg. No. 7681-65-4)
is a pure white crystalline powder. It is prepared by the reaction of
copper sulfate with potassium iodide under slightly acidic conditions.
(b) FDA is developing food-grade specifications for cuprous iodide
in cooperation with the National Academy of Sciences. In the interim,
this ingredient must be of a purity suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(2), the ingredient is used in
food only within the following specific limitations:
------------------------------------------------------------------------
Maximum treatment
Category of food level in food Functional use
------------------------------------------------------------------------
Table salt...................... 0.01 percent...... Source of dietary
iodine.
------------------------------------------------------------------------
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[49 FR 24119, June 12, 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: 21CFR184.1271]
[Page 499-500]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1271 L-Cysteine.
(a) L-Cysteine is the chemical L-2-amino-3-mercaptopropanoic acid
(C3H7O2NS).
(b) The ingredient meets the appropriate part of the specification
set forth in the "Food Chemicals Codex," 3d Ed. (1981), pp. 92-93,
which is incorporated by reference. Copies may be obtained from the
National Academy Press, 2101 Constitution Ave. NW.,
[[Page 500]]
Washington, DC 20418, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(c) The ingredient is used to supply up to 0.009 part of total L-
cysteine per 100 parts of flour in dough as a dough strengthener as
defined in Sec. 170.3(o)(6) of this chapter in yeast-leavened baked
goods and baking mixes as defined in Sec. 170.3(n)(1) of this chapter.
(d) This regulation is issued prior to a general evaluation of use
of this ingredient in order to affirm as GRAS the specific use named.
[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 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: 21CFR184.1272]
[Page 500]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1272 L-Cysteine monohydrochloride.
(a) L-Cysteine monohydrochloride is the chemical L-2-amino-3-
mercaptopropanoic acid monohydrochloride monohydrate
(C3H7O2NS HCl H2O).
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), pp. 92-93, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used to supply up to 0.009 part of total L-
cysteine per 100 parts of flour in dough as a dough strengthener as
defined in Sec. 170.3(o)(6) of this chapter in yeast-leavened baked
goods and baking mixes as defined in Sec. 170.3(n)(1) of this chapter.
(d) This regulation is issued prior to a general evaluation of use
of this ingredient in order to affirm as GRAS the specific use named.
[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 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: 21CFR184.1277]
[Page 500]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1277 Dextrin.
(a) Dextrin
((C6H10O5)n[middot]H2
O, CAS Reg. No. 9004-53-9) is an incompletely hydrolyzed starch. It is
prepared by dry heating corn, waxy maize, waxy milo, potato, arrowroot,
wheat, rice, tapioca, or sago starches, or by dry heating the starches
after: (1) Treatment with safe and suitable alkalis, acids, or pH
control agents and (2) drying the acid or alkali treated starch.
(b) The ingredient meets the specification of the Food Chemicals
Codex, 3d Ed. (1981), p. 96, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a formulation aid as defined in
Sec. 170.3(o)(14) of this chapter; as a processing aid as defined in
Sec. 170.3(o)(24) of this chapter; as a stabilizer and thickener as
defined in Sec. 170.3(o)(28) of this chapter; and as a surface-finishing
agent as defined in Sec. 170.3(o)(30) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 51909, Nov. 15, 1983]
[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: 21CFR184.1278]
[Page 500-501]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1278 Diacetyl.
(a) Diacetyl (C4H6O2, CAS Reg. No.
431-03-8) is a clear yellow to yellowish green liquid with a strong
pungent odor. It is also known as 2,3-butanedione and is chemically
synthesized from methyl ethyl ketone. It is miscible in water, glycerin,
alcohol, and ether, and in very dilute water solution, it has a typical
buttery odor and flavor.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 368, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
[[Page 501]]
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 51907, Nov. 15, 1983]
[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: 21CFR184.1282]
[Page 501]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1282 Dill and its derivatives.
(a) Dill (American or European) is the herb and seeds from Anethum
graveolens L., and dill (Indian) is the herb and seeds from Anethum
sowa, D.C. Its derivatives include essential oils, oleoresins, and
natural extractives obtained from these sources of dill.
(b) Dill oils meet the description and specifications of the "Food
Chemicals Codex," 4th ed. (1996), pp. 122-123, 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) Dill and its derivatives are used as flavoring agents and
adjuvants as defined in Sec. 170.3(o)(12) of this chapter.
(d) The ingredients are used in food at levels not to exceed good
manufacturing practice.
(e) [Reserved]
(f) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
[42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977;
49 FR 5612, Feb. 14, 1984; 64 FR 1760, 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: 21CFR184.1287]
[Page 501]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1287 Enzyme-modified fats.
(a) Enzyme-modified refined beef fat, enzyme-modified butterfat, and
enzyme-modified steam-rendered chicken fat are prepared from refined
beef fat; butterfat or milkfat; and steam-rendered chicken fat,
respectively, with enzymes that are generally recognized as safe (GRAS).
Enzyme-modified milk powder may be prepared with GRAS enzymes from
reconstituted milk powder, whole milk, condensed or concentrated whole
milk, evaporated milk, or milk powder. The lipolysis is maintained at a
temperature that is optimal for the action of the enzyme until
appropriate acid development is attained. The enzymes are then
inactivated. The resulting product is concentrated or dried.
(b) FDA is developing food-grade specifications for these enzyme-
modified ingredients in cooperation with the National Academy of
Sciences. In the interim, the ingredients must be of purity suitable for
their intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredients are used in
food with no limitation other than current good manufacturing practice.
The affirmation of these ingredients as generally recognized as safe
(GRAS) as direct human food ingredients is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredients are used as flavoring agents and adjuvants as
defined in Sec. 170.3(o)(12) of this chapter.
(2) The ingredients are used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
[52 FR 25976, July 10, 1987]
[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: 21CFR184.1293]
[Page 501-502]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1293 Ethyl alcohol.
(a) Ethyl alcohol (ethanol) is the chemical
C2H5OH.
[[Page 502]]
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 4th ed. (1996), p. 136, which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available
from the National Academy Press, Box 285, 2101 Constitution Ave. NW.,
Washington, DC 20055 (Internet address "http://www.nap.edu"), or may
be examined at the Center for Food Safety and Applied Nutrition's
Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, or at the Office of the Federal Register, 800 North
Capitol St. NW., suite 700, Washington, DC.
(c) The ingredient is used as an antimicrobial agent as defined in
Sec. 170.3(o)(2) of this chapter on pizza crusts prior to final baking
at levels not to exceed 2.0 percent by product weight.
(d) This regulation is issued prior to general evaluation of use of
this ingredient in order to affirm as GRAS the specific use named.
[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984; 64
FR 1760, 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: 21CFR184.1295]
[Page 502]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1295 Ethyl formate.
(a) Ethyl formate (C3H6O2, CAS Reg.
No. 109-94-4) is also referred to as ethyl methanoate. It is an ester of
formic acid and is prepared by esterification of formic acid with ethyl
alcohol or by distillation of ethyl acetate and formic acid in the
presence of concentrated sulfuric acid. Ethyl formate occurs naturally
in some plant oils, fruits, and juices but does not occur naturally in
the animal kingdom.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), p. 376, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as a flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practice in accordance with Sec. 184.1(b)(1). Current good
manufacturing practice results in a maximum level, as served, of 0.05
percent in baked goods as defined in Sec. 170.3(n)(1) of this chapter;
0.04 percent in chewing gum as defined in Sec. 170.3(n)(6), hard candy
as defined in Sec. 170.3(n)(25), and soft candy as defined in
Sec. 170.3(n)(38) of this chapter; 0.02 percent in frozen dairy desserts
as defined in Sec. 170.3(n)(20) of this chapter; 0.03 percent in
gelatins, puddings, and fillings as defined in Sec. 170.3(n)(22) of this
chapter; and 0.01 percent in all other food categories.
(e) Prior sanctions for ethyl formate different from the uses
established in this section do not exist or have been waived.
[45 FR 22915, Apr. 4, 1980, as amended at 49 FR 5612, Feb. 14, 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: 21CFR184.1296]
[Page 502-503]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1296 Ferric ammonium citrate.
(a) Ferric ammonium citrate (iron (III) ammonium citrate) is
prepared by the reaction of ferric hydroxide with citric acid, followed
by treatment with ammonium hydroxide, evaporating, and drying. The
resulting product occurs in two forms depending on the stoichiometry of
the initial reactants.
(1) Ferric ammonium citrate (iron (III) ammonium citrate, CAS Reg.
No. 1332-98-5) is a complex salt of undetermined structure composed of
16.5 to 18.5 percent iron, approximately 9 percent ammonia, and 65
percent citric acid and occurs as reddish brown or garnet red scales or
granules or as a brownish-yellowish powder.
(2) Ferric ammonium citrate (iron (III) ammonium citrate, CAS Reg.
No. 1333-00-2) is a complex salt of undetermined structure composed of
14.5 to 16 percent iron, approximately 7.5 percent ammonia, and 75
percent citric acid and occurs as thin transparent green scales, as
granules, as a powder, or as transparent green crystals.
(b) The ingredients meet the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 116-117 (Ferric ammonium citrate, brown) and
p. 117 (Ferric ammonium citrate, green), which is incorporated by
reference. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or available for inspection
at the Office of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC 20408.
[[Page 503]]
(c) In accordance with Sec. 184.1(b)(1), the ingredients are used in
food as nutrient supplements as defined in Sec. 170.3(o)(20) of this
chapter, with no limitation other than current good manufacturing
practice. The ingredients may also be used in infant formula in
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
[53 FR 16864, May 12, 1988]
[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: 21CFR184.1297]
[Page 503]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1297 Ferric chloride.
(a) Ferric chloride (iron (III) chloride, FeC13, CAS Reg.
No. 7705-08-0) may be prepared from iron and chlorine or from ferric
oxide and hydrogen chloride. The pure material occurs as hydroscopic,
hexagonal, dark crystals. Ferric chloride hexahydrate (iron (III)
chloride hexahydrate, FeC13. 6H20, CAS Reg. No.
10025-77-1) is readily formed when ferric chloride is exposed to
moisture.
(b) The Food and Drug Administration is developing food-grade
specifications for ferric chloride in cooperation with the National
Academy of Sciences. In the interim, this ingredient must be of a purity
suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1) the ingredient is used in
food as a flavoring agent as defined in Sec. 170.3(o)(12) of this
chapter, with no limitation other than current good manufacturing
practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[53 FR 16864, May 12, 1988]
[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: 21CFR184.1298]
[Page 503]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1298 Ferric citrate.
(a) Ferric citrate (iron (III) citrate,
C6H5FeO7, CAS Reg. No. 2338-05-8) is
prepared from reaction of citric acid with ferric hydroxide. It is a
compound of indefinite ratio of citric acid and iron.
(b) The Food and Drug Administration is developing food-grade
specifications for ferric citrate in cooperation with the National
Academy of Sciences. In the interim, this ingredient must be of a purity
suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this
chapter, with no limitation other than current good manufacturing
practice. The ingredient may also be used in infant formula in
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[53 FR 16865, May 12, 1988]
[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: 21CFR184.1301]
[Page 503-504]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1301 Ferric phosphate.
(a) Ferric phosphate (ferric orthophosphate, iron (III) phosphate,
FePO4[middot]xH2O, CAS Reg. No. 10045-86-0) is an
odorless, yellowish-white to buff-colored powder and contains from one
to four molecules of water of hydration. It is prepared by reaction of
sodium phosphate with ferric chloride or ferric citrate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 118-120, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food as nutrient supplement as defined in Sec. 170.3(o)(20) of this
chapter, with no limitation other than current good manufacturing
practice. The ingredient may also be used in infant formula in
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses
established in
[[Page 504]]
this section do not exist or have been waived.
[53 FR 16865, May 12, 1988]
[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: 21CFR184.1304]
[Page 504]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1304 Ferric pyrophosphate.
(a) Ferric pyrophosphate (iron (III) pyrophosphate,
Fe4(P207)3[middot]xH2O, CAS
Reg. No. 10058-44-3) is a tan or yellowish white colorless powder. It is
prepared by reacting sodium pyrophosphate with ferric citrate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 120, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this
chapter, with no limitation other than current good manufacturing
practice. The ingredient may also be used in infant formula in
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[53 FR 16865, May 12, 1988; 53 FR 20939, June 7, 1988]
[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: 21CFR184.1307]
[Page 504]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1307 Ferric sulfate.
(a) Ferric sulfate (iron (III) sulfate,
Fe2(SO4)3, CAS Reg. No. 10028-22-5) is
a yellow substance that may be prepared by oxidizing iron (II) sulfate
or by treating ferric oxide or ferric hydroxide with sulfuric acid.
(b) The Food and Drug Administration is developing food-grade
specifications for ferric sulfate in cooperation with the National
Academy of Sciences. In the interim, this ingredient must be of a purity
suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food as a flavoring agent as defined in Sec. 170.3(o)(12) of this
chapter, with no limitation other than current good manufacturing
practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[53 FR 16865, May 12, 1988]
[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: 21CFR184.1307a]
[Page 504]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1307a Ferrous ascorbate.
(a) Ferrous ascorbate (CAS Reg. No. 14536-17-5) is a reaction
product of ferrous hydroxide and ascorbic acid. It is a blue-violet
product containing 16 percent iron.
(b) The Food and Drug Administration is developing food-grade
specifications for ferrous ascorbate in cooperation with the National
Academy of Sciences. In the interim, this ingredient must be of a purity
suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this
chapter, with no limitation other than current good manufacturing
practice. The ingredient may also be used in infant formula in
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[53 FR 16865, May 12, 1988]
[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: 21CFR184.1307b]
[Page 504-505]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1307b Ferrous carbonate.
(a) Ferrous carbonate (iron (II) carbonate, FeCO3, CAS
Reg. No. 563-71-3) is an odorless, white solid prepared by treating
solutions of iron (II) salts with alkali carbonate salts.
(b) The Food and Drug Administration is developing food-grade
specifications for ferrous carbonate in cooperation with the National
Academy of Sciences. In the interim, this ingredient must be of a purity
suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this
chapter, with no
[[Page 505]]
limitation other than current good manufacturing practice. The
ingredient may also be used in infant formula in accordance with section
412(g) of the Federal Foods, Drug, and Cosmetic Act (the act) (21 U.S.C.
350a(g)) or with regulations promulgated under section 412(a)(2) of the
act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[53 FR 16865, May 12, 1988]
[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: 21CFR184.1307c]
[Page 505]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1307c Ferrous citrate.
(a) Ferrous citrate (iron (II) citrate,
(C6H6FeO7), CAS Reg. No. 23383-11-1) is
a slightly colored powder or white crystals. It is prepared from the
reaction of sodium citrate with ferrous sulfate or by direct action of
citric acid on iron filings.
(b) The Food and Drug Administration is developing food-grade
specifications for ferrous citrate in cooperation with the National
Academy of Sciences. In the interim, this ingredient must be of a purity
suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1) the ingredient is used in
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this
chapter, with no limitation other than current good manufacturing
practice. The ingredient may also be used in infant formula in
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[53 FR 16866, May 12, 1988]
[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: 21CFR184.1307d]
[Page 505]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1307d Ferrous fumarate.
(a) Ferrous fumarate (iron (II) fumarate,
(C4H2FeO4), CAS Reg. No. 141-01-5) is
an odorless, reddish-orange to reddish-brown powder. It may contain soft
lumps that produce a yellow streak when crushed. It is prepared by
admixing hot solutions of ferrous sulfate and sodium fumarate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 120-122, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave NW., Washington, DC 20418, or available for inspection at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1) the ingredient is used in
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this
chapter, with no limitation other than current good manufacturing
practice. The ingredient may also be used in infant formula in
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 350a(g)), or with regulations promulgated under
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[53 FR 16866, May 12, 1988]
[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: 21CFR184.1308]
[Page 505-506]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1308 Ferrous gluconate.
(a) Ferrous gluconate (iron (II) gluconate dihydrate,
C12H22FeO14[middot]2H2O, CAS
Reg. No. 6047-12-7) is a fine yellowish-gray or pale greenish-yellow
powder or granules. It is prepared by reacting hot solutions of barium
or calcium gluconate with ferrous sulfate or by heating freshly prepared
ferrous carbonate with gluconic acid in aqueous solution.
(b) The ingredient meets the specifications of the Food Chemcials
Codex, 3d Ed. (1981), pp. 122-123, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Avenue NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this
chapter, with no limitation other than current good manufacturing
practice. The ingredient may also be used in infant formula in
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under
[[Page 506]]
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[53 FR 16866, May 12, 1988; 53 FR 20939, June 7, 1988]
[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: 21CFR184.1311]
[Page 506]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1311 Ferrous lactate.
(a) Ferrous lactate (iron (II) lactate,
C6H10FeO6, CAS Reg. No. 5905-52-2) in
the trihydrate form is a greenish-white powder or crystalline mass. It
is prepared by reacting calcium lactate or sodium lactate with ferrous
sulfate, direct reaction of lactic acid with iron filings, reaction of
ferrous chloride with sodium lactate, or reaction of ferrous sulfate
with ammonium lactate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 4th ed. (1996), pp. 154 to 155, which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or may be examined at the Center for Food
Safety and Applied Nutrition's library, 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) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this
chapter and as a color fixative for ripe olives, with no other
limitation other than current good manufacturing practice. The
ingredient may also be used in infant formula in accordance with section
412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
350a(g)) or with regulations promulgated under section 412(a)(2) of the
act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[53 FR 16866, May 12, 1988, as amended at 61 FR 40319, Aug. 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: 21CFR184.1315]
[Page 506]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1315 Ferrous sulfate.
(a) Ferrous sulfate heptahydrate (iron (II) sulfate heptahydrate,
FeSO4[middot]7H2O, CAS Reg. No. 7782-63-0) is
prepared by the action of sulfuric acid on iron. It occurs as pale,
bluish-green crystals or granules. Progressive heating of ferrous
sulfate heptahydrate produces ferrous sulfate (dried). Ferrous sulfate
(dried) consists primarily of ferrous sulfate monohydrate (CAS Reg. No.
17375-41-6) with varying amounts of ferrous sulfate tetrahydrate (CAS
Reg. No. 20908-72-9) and occurs as a grayish-white to buff-colored
powder.
(b) The ingredients meet the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 123 (Ferrous sulfate heptahydrate) and p. 124
(ferrous sulfate, dried), which is incorporated by reference. Copies are
available from the National Academy Press, 2101 Constitution Ave., NW.,
Washington, DC 20418, or available for inspection at the Office of
Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredients are used in
food as nutrient supplements as defined in Sec. 170.3(o)(20) of this
chapter and as a processing aid as defined in Sec. 170.3(o)(24) of this
chapter, with no limitation other than current good manufacturing
practice. The ingredients may also be used in infant formula in
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
[53 FR 16866, May 12, 1988]
[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: 21CFR184.1316]
[Page 506-507]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1316 Ficin.
(a) Ficin (CAS Reg. No. 9001-33-6) is an enzyme preparation obtained
from the latex of species of the genus Ficus, which include a variety of
tropical fig trees. It is a white to off-white powder. Its
characterizing enzyme activity is that of a peptide hydrolase (EC
3.4.22.3).
(b) The ingredient meets the general requirements and additional
requirements for enzyme preparations in the Food Chemicals Codex, 3d ed.
(1981), p. 110, which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1
[[Page 507]]
CFR part 51. Copies are available from the National Academy Press, 2101
Constitution Ave., NW., Washington, DC 20418, or may be examined at the
Office of Premarket Approval (HFS-200), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, and the Office of the
Federal Register, 800 North Capitol St., NW., suite 700, Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as GRAS as a direct food ingredient
is based upon the following current good manufacturing practice
conditions of use:
(1) The ingredient is used as an enzyme as defined in
Sec. 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
[60 FR 32910, June 26, 1995]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1317]
[Page 507]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1317 Garlic and its derivatives.
(a) Garlic is the fresh or dehydrated bulb or cloves obtained from
Allium sativum, a genus of the lily family. Its derivatives include
essential oils, oleo-resins, and natural extractives obtained from
garlic.
(b) Garlic oil meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), p. 132, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) Garlic and its derivatives are used as flavoring agents and
adjuvants as defined in Sec. 170.3(o)(12) of this chapter.
(d) The ingredients are used in food at levels not to exceed good
manufacturing practice.
(e) [Reserved]
(f) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977;
49 FR 5612, Feb. 14, 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: 21CFR184.1318]
[Page 507]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1318 Glucono delta-lactone.
(a) Glucono delta-lactone (C6H10O6,
CAS Reg. No. 90-80-2), also called D-gluconic acid delta-lactone or D-
glucono-1,5-lactone, is the cyclic 1,5-intramolecular ester of D-
gluconic acid. It is prepared by direct crystallization from the aqueous
solution of gluconic acid. Gluconic acid may be produced by the
oxidation of D-glucose with bromine water, by the oxidation of D-glucose
by microorganisms that are nonpathogenic and nontoxicogenic to man or
other animals, or by the oxidation of D-glucose with enzymes derived
from these microorganisms.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 134, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a curing and pickling agent as defined
in Sec. 170.3(o)(5) of this chapter, leavening agent as defined in
Sec. 170.3(o)(17) of this chapter; pH control agent as defined in
Sec. 170.3(o)(23) of this chapter; and sequestrant as defined in
Sec. 170.3(o)(26) of this chapter.
(2) The ingredient is used at levels not to exceed current good
manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[51 FR 33896, Sept. 24, 1986]
[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: 21CFR184.1321]
[Page 507-508]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1321 Corn gluten.
(a) Corn gluten (CAS Reg. No. 66071-96-3), also known as corn gluten
meal, is the principal protein component of corn endosperm. It consists
mainly of
[[Page 508]]
zein and glutelin. Corn gluten is a byproduct of the wet milling of corn
for starch. The gluten fraction is washed to remove residual water
soluble proteins. Corn gluten is also produced as a byproduct during the
conversion of the starch in whole or various fractions of dry milled
corn to corn syrups.
(b) FDA is developing food-grade specifications for corn gluten in
cooperation with the National Academy of Sciences. In the interim, the
ingredient must be of a purity suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter and a texturizer as defined in
Sec. 170.3(o)(32) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 8998, Mar. 6, 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: 21CFR184.1322]
[Page 508]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1322 Wheat gluten.
(a) Wheat gluten (CAS Reg. No. 8002-80-0) is the principal protein
component of wheat and consists mainly of gliadin and glutenin. Wheat
gluten is obtained by hydrating wheat flour and mechanically working the
sticky mass to separate the wheat gluten from the starch and other flour
components. Vital gluten is dried gluten that has retained its elastic
properties.
(b) FDA is developing food-grade specifications for wheat gluten in
cooperation with the National Academy of Sciences. In the interim, the
ingredient must be of a purity suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a dough strengthener as defined in
Sec. 170.3(o)(6) of this chapter; a formulation aid as defined in
Sec. 170.3(o)(14) of this chapter; a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter; a processing aid as defined in
Sec. 170.3(o)(24) of this chapter; a stabilizer and thickener as defined
in Sec. 170.3(o)(28) of this chapter; a surface-finishing agent as
defined in Sec. 170.3(o)(30) of this chapter; and a texturizing agent as
defined in Sec. 170.3(o)(32) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 8998, Mar. 6, 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: 21CFR184.1323]
[Page 508-509]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1323 Glyceryl monooleate.
(a) Glyceryl monooleate is prepared by esterification of commerical
oleic acid that is derived either from edible sources or from tall oil
fatty acids meeting the requirements of Sec. 172.862 of this chapter. It
contains glyceryl monooleate (C21H40O4,
CAS Reg. No. 25496-72-4) and glyceryl esters of fatty acids present in
commercial oleic acid.
(b) FDA is developing food-grade specifications for glyceryl
monooleate in cooperation with the National Academy of Sciences. In the
interim, this ingredient must be of a purity suitable for its intended
use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter and as a solvent and
vehicle as defined in Sec. 170.3(o)(27) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice:
[[Page 509]]
baked goods and baking mixes as defined in Sec. 170.3(n)(1) of this
chapter; nonalcoholic beverages and beverage bases as defined in
Sec. 170.3(n)(3) of this chapter; chewing gum as defined in
Sec. 170.3(n)(6) of this chapter; and meat products as defined in
Sec. 170.3(n)(29) of this chapter.
(d) Prior sanctions for this ingredient different from the use
established in this section do not exist or have been waived.
[54 FR 7403 Feb. 21, 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: 21CFR184.1324]
[Page 509]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1324 Glyceryl monostearate.
(a) Glyceryl monostearate, also known as monostearin, is a mixture
of variable proportions of glyceryl monostearate
(C21H42O4, CAS Reg. No. 31566-31-1),
glyceryl monopalmitate (C19H38O4, CAS
Reg. No. 26657-96-5) and glyceryl esters of fatty acids present in
commercial stearic acid. Glyceryl monostearate is prepared by
glycerolysis of certain fats or oils that are derived from edible
sources or by esterification, with glycerin, of stearic acid that is
derived from edible sources.
(b) FDA is developing food-grade specifications for glyceryl
monostearate in cooperation with the National Academy of Sciences. In
the interim, this ingredient must be of a purity suitable for its
intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not not exist or have been waived.
[54 FR 7403 Feb. 21, 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: 21CFR184.1328]
[Page 509]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1328 Glyceryl behenate.
(a) Glyceryl behenate is a mixture of glyceryl esters of behenic
acid made from glycerin and behenic acid (a saturated C22
fatty acid). The mixture contains predominately glyceryl dibehenate.
(b) The ingredient meets the following specifications:
(1) 10 to 20 percent monoglyceride, 47 to 59 percent diglyceride, 26
to 38 percent triglyceride, and not more than 2.5 percent free fatty
acids.
(2) Behenic acid. Between 80 and 90 percent of the total fatty acid
content.
(3) Acid value. Not more than 4.
(4) Saponification value. Between 145 and 165.
(5) Iodine number. Not more than 3.
(6) Heavy metals (as Pb). Not more than 10 parts per million.
(c) In accordance with Sec. 184.1(b)(1) of this chapter, the
ingredient is used in food with no limitation other than current good
manufacturing practice. The affirmation of this ingredient is generally
recognized as safe (GRAS) as a direct human food ingredient is based
upon the following current good manufacturing practice conditions of
use:
(1) The ingredient is used as a formulation aid, as defined in
Sec. 170.3(o)(14) of this chapter.
(2) The ingredient is used in excipient formulations for use in
tablets at levels not to exceed good manufacturing practice.
[52 FR 42430, Nov. 5, 1987]
[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: 21CFR184.1329]
[Page 509]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1329 Glyceryl palmitostearate.
(a) Glyceryl palmitostearate is a mixture of mono-, di-, and
triglyceryl esters of palmitic and stearic acids made from glycerin,
palmitic acid, and stearic acid.
(b) The ingredient meets the following specifications:
(1) The substance is a mixture of mono-, di-, and triglycerides of
palmitic acid and stearic acid.
(2) Heavy metals (as lead): Not more than 10 parts per million.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a formulation aid, as defined in
Sec. 170.3(o)(14) of this chapter.
(2) The ingredient is used in excipient formulations for use in
tablets at levels not to exceed good manufacturing practice.
[60 FR 63621, Dec. 12, 1995]
[[Page 510]]
[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: 21CFR184.1330]
[Page 510]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1330 Acacia (gum arabic).
(a) Acacia (gum arabic) is the dried gummy exudate from stems and
branches of trees of various species of the genus Acacia, family
Leguminosae.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), p. 7, which is incorporated by reference. Copies
may be obtained from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or may be examined at the Office of the
Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
DC 20408.
(c) The ingredient is used in food under the following conditions:
Maximum Usage Levels Permitted
------------------------------------------------------------------------
Food (as served) Percent Function
------------------------------------------------------------------------
Beverages and beverage bases, 2.0 Emulsifier and emulsifier
Sec. 170.3(n)(3) of this salt, Sec. 170.3(o)(8) of
chapter. this chapter; flavoring
agent and adjuvant, Sec.
170.3(o)(12) of this
chapter; formulation aid,
Sec. 170.3(o)(14) of this
chapter; stabilizer and
thickener, Sec.
170.3(o)(28) of this
chapter.
Chewing gum, Sec. 5.6 Flavoring agent and adjuvant,
170.3(n)(6) of this chapter. Sec. 170.3(o)(12) of this
chapter; formulation aid,
Sec. 170.3(o)(14) of this
chapter; humectant, Sec.
170.3(o)(16) of this
chapter; surface-finishing
agent, Sec. 170.3(o)(30) of
this chapter.
Confections and frostings, 12.4 Formulation aid, Sec.
Sec. 170.3(n)(9) of this 170.3(o)(14) of this
chapter. chapter; stabilizer and
thickener, Sec.
170.3(o)(28) of this
chapter; surface-finishing
agent, Sec. 170.3(o)(30) of
this chapter.
Dairy product analogs, Sec. 1.3 Formulation aid, Sec.
170.3(n)(10) of this chapter. 170.3(o)(14) of this
chapter; stabilizer and
thickener, Sec.
170.3(o)(28) of this
chapter.
Fats and oils, Sec. 1.5 Formulation aid, Sec.
170.3(n)(12) of this chapter. 170.3(o)(14) of this
chapter; stabilizer and
thickener, Sec.
170.3(o)(28) of this
chapter.
Gelatins, puddings, and 2.5 Emulsifier and emulsifier
fillings, Sec. 170.3(n)(22) salt, Sec. 170.3(o)(8) of
of this chapter. this chapter; formulation
aid, Sec. 170.3(o)(14) of
this chapter.; stabilizer
and thickener, Sec.
170.3(o)(28) of this
chapter.
Hard candy and cough drops, 46.5 Flavoring agent and adjuvant,
Sec. 170.3(n)(25) of this Sec. 170.3(o)(12) of this
chapter. chapter; formulation aid,
Sec. 170.3(o)(14) of this
chapter.
Nuts and nut products, Sec. 8.3 Formulation aid, Sec.
170.3(n)(32) of this chapter. 170.3(o)(14) of this
chapter; surface-finishing
agent, Sec. 170.3(o)(30) of
this chapter.
Quiescently frozen confection 6.0 Formulation aid, Sec.
products. 170.3(o)(14) of this
chapter; stabilizer and
thickener, Sec.
170.3(o)(28) of this
chapter.
Snack foods, Sec. 4.0 Emulsifier and emulsifier
170.3(n)(37) of this chapter. salt, Sec. 170.3(o)(8) of
this chapter; formulation
aid, Sec. 170.3(o)(14) of
this chapter.
Soft candy, Sec. 85.0 Emulsifier and emulsifier
170.3(n)(38) of this chapter. salt, Sec. 170.3(o)(8) of
this chapter; firming agent,
Sec. 170.3(o)(10) of this
chapter; flavoring agent and
adjuvant, Sec. 170.3(o)(12)
of this chapter; formulation
aid, Sec. 170.3(o)(14) of
this chapter, humectant,
Sec. 170.3(o)(16) of this
chapter; stabilizer and
thickener, Sec.
170.3(o)(28) of this
chapter; surface-finishing
agent, Sec. 170.3(o)(30) of
this chapter.
All other food categories.... 1.0 Emulsifier and emulsifier
salt, Sec. 170.3(o)(8) of
this chapter; flavoring
agent and adjuvant, Sec.
170.3(o)(12) of this
chapter; formulation aid,
Sec. 170.3(o)(14) of this
chapter; processing aid,
Sec. 170.3(o)(24) of this
chapter; stabilizer and
thickener, Sec.
170.3(o)(28) of this
chapter; surface-finishing
agent, Sec. 170.3(o)(30) of
this chapter; texturizer,
Sec. 170.3(o)(32) of this
chapter.
------------------------------------------------------------------------
(d) [Reserved]
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977;
49 FR 5612, Feb. 14, 1983; 53 FR 5766, Feb. 26, 1988]
[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: 21CFR184.1333]
[Page 510-511]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1333 Gum ghatti.
(a) Gum ghatti (Indian gum) is an exudate from wounds in the bark of
Anogeissus latifolia, a large tree found in the dry deciduous forests of
India and Ceylon.
(b) The ingredient complies with the following specifications:
(1) Viscosity of a 1-percent solution. Not less than the minimum or
within the range claimed by the vendor.
(2) Limits of impurities--(i) Arsenic (as AL). Not more than 3 parts
per million (0.0003 percent);
[[Page 511]]
(ii) Ash (acid-insoluble). Not more than 1.75 percent;
(iii) Ash (total). Not more than 6.0 percent;
(iv) Heavy metals (as Pb). Not more than 40 parts per million (0.004
percent); and
(v) Lead. Not more than 10 parts per million (0.001 percent).
(3) Loss on drying. Not more than 14 percent dried at 105 deg.C for
5 hours.
(4) Identification test. Add 0.2 ml of diluted lead acetate as
outlined in "Official Methods of Analysis of the Association of
Official Analytical Chemists," 13th Ed. (1980), section 31.178(b), p.
529, under "Dilute Basic Lead Acetate Standard Solution," which is
incorporated by reference (copies are available from the Association of
Official Analytical Chemists, P.O. Box 540, Benjamin Franklin Station,
Washington, DC 20044, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408), to 5 ml of a cold 1-in-100 aqueous solution of the gum. An
immediate, voluminous, opaque precipitate indicates acacia. A small
precipitate or clear solution which produces an opaque flocculent
precipitate upon the additon of 1 ml of 3 N ammonimum hydroxide
indicates gum ghatti.
(c) The ingredient is used in food under the following conditions:
Maximum Usage Levels Permitted
------------------------------------------------------------------------
Food (as served) Percent Function
------------------------------------------------------------------------
Beverages and beverage bases, 0.2 Emulsifier and emulsifier
nonalcoholic, Sec. salt, Sec. 170.3(o)(8) of
170.3(n)(3) of this chapter. this chapter.
All other food categories.... .1 Emulsifier and emulsifier
salt, Sec. 170.3(o)(8) of
this chapter.
------------------------------------------------------------------------
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 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: 21CFR184.1339]
[Page 511-512]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1339 Guar gum.
(a) Guar gum is the natural substance obtained from the maceration
of the seed of the guar plant, Cyamopsis tetragonoloba (Linne) Taub., or
Cyamopsis psoraloides (Lam.) D.C.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), p. 141, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used in food under the following conditions:
Maximum Usage Levels Permitted
------------------------------------------------------------------------
Food (as served) Percent Function
------------------------------------------------------------------------
Baked goods and baking mixes, 0.35 Emulsifier and emulsifier
Sec. 170.3(n)(1) of this salts, Sec. 170.3(o)(8) of
chapter. this chapter; formulation
aid, Sec. 170.3(o)(14) of
this chapter; stabilizer and
thickener; Sec.
170.3(o)(28) of this
chapter.
Breakfast cereals, Sec. 1.2 Formulation aid, Sec.
170.3(n)(4) of this chapter. 170.3(o)(14) of this
chapter; stabilizer and
thickener, Sec.
170.3(o)(28) of this
chapter.
Cheese, Sec. 170.3(n)(5) of .8 Do.
this chapter.
Dairy products analogs, Sec. 1.0 Firming agent, Sec.
170.3(n)(10) of this chapter. 170.3(o)(10) of this
chapter; formulation aid,
Sec. 170.3(o)(14) of this
chapter; stabilizer and
thickener, Sec.
170.3(o)(28) of this
chapter.
Fats and oils, Sec. 2.0 Do.
170.3(n)(12) of this chapter.
Gravies and sauces, Sec. 1.2 Formulation aid, Sec.
170.3(n)(24) of this chapter. 170.3(o)(14) of this
chapter; stabilizer and
thickener, Sec.
170.3(o)(28) of this
chapter.
Jams and jellies, commercial, 1.0 Do.
Sec. 170.3(n)(28) of this
chapter.
Milk products, Sec. .6 Do.
170.3(n)(31) of this chapter.
Processed vegetables and 2.0 Formulation aid, Sec.
vegetable juices, Sec. 170.3(o)(14) of this
170.3(n)(36) of this chapter. chapter; stabilizer and
thickener, Sec.
170.3(o)(28) of this
chapter.
Soups and soup mixes, Sec. .8 Do.
170.3(n)(40) of this chapter.
[[Page 512]]
Sweet sauces, toppings and 1.0 Do.
syrups, Sec. 170.3(n)(43)
of this chapter.
All other food categories.... .5 Emulsifier and emulsifier
salts, Sec. 170.3(o)(8) of
this chapter; firming agent,
Sec. 170.3(o)(10) of this
chapter; formulation aid,
Sec. 170.3(o)(14) of this
chapter; stabilizer and
thickener, Sec.
170.3(o)(28) of this
chapter.
------------------------------------------------------------------------
(d) [Reserved]
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977;
49 FR 5612, Feb. 14, 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: 21CFR184.1343]
[Page 512]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1343 Locust (carob) bean gum.
(a) Locust (carob) bean gum is primarily the macerated endosperm of
the seed of the locust (carob) bean tree, Ceratonia siliqua (Linne), a
leguminous evergreen tree, with lesser quantities of seed coat and germ.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), pp. 174-175, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used at levels not to exceed the following
maximum levels:
Maximum Usage Levels Permitted
------------------------------------------------------------------------
Food (as served) Percent Function
------------------------------------------------------------------------
Baked goods and baking mixes, 0.15 Stabilizer and thickener,
Sec. 170.3(n)(1) of this Sec. 170.3(o)(28) of this
chapter. chapter.
Beverages and beverage bases, .25 Do.
nonalcoholic, Sec.
170.3(n)(3) of this chapter.
Cheeses, Sec. 170.3(n)(5) of .8 Do.
this chapter.
Gelatins, puddings, and .75 Do.
fillings, Sec. 170.3(n)(22)
of this chapter.
Jams and jellies, commercial, .75 Do.
Sec. 170.3(n)(28) of this
chapter.
All other food categories.... .5 Do.
------------------------------------------------------------------------
(d) [Reserved]
(e) Prior sanctions for this ingredient different from the uses
established in this regulation do not exist or have been waived.
[42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977;
49 FR 5612, Feb. 14, 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: 21CFR184.1349]
[Page 512-513]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1349 Karaya gum (sterculia gum).
(a) Karaya gum (sterculia gum) is the dried gummy exudate from the
trunk of trees of various species of the genus Sterculia.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), p. 157, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used in food under the following conditions:
Maximum Usage Levels Permitted
------------------------------------------------------------------------
Food (as served) Percent Function
------------------------------------------------------------------------
Frozen dairy desserts and 0.3 Formulation aid, Sec.
mixes, Sec. 170.3(n)(20) of 170.3(o)(14) of this
this chapter. chapter; stabilizer and
thickener, Sec.
170.3(o)(28) of this
chapter.
[[Page 513]]
Milk products, Sec. .02 Stabilizer and thickener,
170.3(n)(31) of this chapter. Sec. 170.3(o)(28) of this
chapter.
Soft candy, Sec. .9 Emulsifier and emulsifier
170.3(n)(38) of this chapter. salt, Sec. 170.3(o)(8) of
this chapter; stabilizer and
thickener, Sec.
170.3(o)(28) of this
chapter.
All other food categories.... .002 Formulation aid, Sec.
170.3(o)(14) of this
chapter; stabilizer and
thickener, Sec.
170.3(o)(28) of this
chapter.
------------------------------------------------------------------------
(d) [Reserved]
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977;
49 FR 5612, Feb. 14, 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: 21CFR184.1351]
[Page 513]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1351 Gum tragacanth.
(a) Gum tragacanth is the exudate from one of several species of
Astragalus gummifier Labillardiere, a shrub that grows wild in
mountainous regions of the Middle East.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), p. 337, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used in food under the following conditions:
Maximum Usage Levels Permitted
------------------------------------------------------------------------
Food (as served) Percent Function
------------------------------------------------------------------------
Baked goods and baking mixes, 0.2 Emulsifier and emulsifier
Sec. 170.3(n)(1) of this salt, Sec. 170.3(o)(8) of
chapter. this chapter; formulation
aid, Sec. 170.3(o)(14) of
this chapter; stabilizer and
thickener, Sec.
170.3(o)(28) of this
chapter.
Condiments and relishes, Sec. .7 Do.
170.3(n)(8) of this chapter.
Fats and oils, Sec. 1.3 Do.
170.3(n)(12) of this chapter.
Gravies and sauces, Sec. .8 Do.
170.3(n)(24) of this chapter.
Meat products, Sec. .2 Formulation aid, Sec.
170.3(n)(29) of this chapter. 170.3(o)(14) of this
chapter; stabilizer and
thickener, Sec.
170.3(o)(28) of this
chapter.
Processed fruits and fruit .2 Emulsifier and emulsifier
juices, Sec. 170.3(n)(35) salt, Sec. 170.3(o)(8) of
of this chapter. this chapter; formulation
aid, Sec. 170.3(o)(14) of
this chapter; stabilizer and
thickener, Sec.
170.3(o)(28) of this
chapter.
All other food categories.... .1 Do.
------------------------------------------------------------------------
(d) [Reserved]
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977;
49 FR 5612, Feb. 14, 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: 21CFR184.1355]
[Page 513-514]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1355 Helium.
(a) Helium (empirical formula He, CAS Reg. No. 7440-59-7) is a
colorless, odorless, flavorless, nonflammable, inert gas. It is lighter
than air and is produced by the liquefaction and purification of natural
gas.
(b) The Food and Drug Administration is developing food-grade
specifications for helium in cooperation with the National Academy of
Sciences. In the interim, the ingredient must be of a purity suitable
for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitations other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a processing aid as defined in
Sec. 170.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
[[Page 514]]
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 57270, Dec. 29, 1983]
[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: 21CFR184.1366]
[Page 514]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1366 Hydrogen peroxide.
(a) Hydrogen peroxide (H2O2, CAS Reg. No.
7722-84-1) is also referred to as hydrogen dioxide. It is made by the
electrolytic oxidation of sulfuric acid or a sulfate to persulfuric acid
or a persulfuric acid salt with subsequent hydrolysis and distillation
of the hydrogen peroxide formed; by decomposition of barium peroxide
with sulfuric or phosphoric acid; by hydrogen reduction of 2-
ethylanthraquinone, followed by oxidation with air, to regenerate the
quinone and produce hydrogen peroxide; or by electrical discharge
through a mixture of hydrogen, oxygen, and water vapor.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d ed. (1981), pp. 146-147, \1\ which is incorporated by
reference.
---------------------------------------------------------------------------
\1\ Copies may be obtained from the National Academy of Sciences,
2101 Constitution Ave. NW, Washington, DC 20037, or examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
---------------------------------------------------------------------------
(c) In accordance with Sec. 184.1(b)(2), the ingredient is used to
treat food only within the following specific limitations:
------------------------------------------------------------------------
Maximum treatment
Food level in food Functional use
(percent)
------------------------------------------------------------------------
Milk, intended for use during 0.05.................. Antimicrobial
the cheesemaking process as agent as
permitted in the appropriate defined in Sec.
standards of identity for 170.3 (o)(2)
cheese and related cheese of this chapter
products under part 133 of
this chapter.
Whey, during the preparation 0.04.................. do.
of modified whey by
electrodialysis methods.
Dried eggs, dried egg whites, Amount sufficient for Oxidizing and
and dried egg yolks as in the purpose. reducing agent
Secs. 160.105, 160.145, and as defined in
160.185 of this chapter. Sec. 170.3
(o)(22) of this
chapter
Tripe......................... do.................... Bleaching agent.
Beef feet..................... Amount sufficient for Bleaching agent.
the purpose.
(Hydrogen peroxide
may be in the form of
a compound salt,
sodium carbonate
peroxide).
Herring....................... Amount sufficient for do.
the purpose.
Wine.......................... do.................... Oxidizing and
reducing agent
as defined in
Sec. 170.3
(o)(22) of this
chapter.
Starch........................ 0.15.................. Antimicrobial
agent as
defined in Sec.
170.3 (o)(2) of
this chapter,
to produce
thermophile-
free starch;
Remove sulfur
dioxide from
starch slurry
following
steeping and
grinding
operations of
corn refining.
Instant tea................... Amount sufficient for Bleaching agent.
the purpose.
Corn syrup.................... 0.15.................. Reduce sulfur
dioxide levels
in the finished
corn syrup.
Colored (annatto) cheese whey. 0.05.................. Bleaching agent.
Wine vinegar.................. Amount sufficient for Remove sulfur
the purpose. dioxide from
wine prior to
fermentation to
produce
vinegar.
Emulsifiers containing fatty 1.25.................. Bleaching agent.
acid esters.
------------------------------------------------------------------------
(d) Residual hydrogen peroxide is removed by appropriate physical
and chemical means during the processing of food where it has been used
according to paragraph (c) of this section.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[46 FR 44439, Sept. 4, 1981, as amended at 51 FR 27172, July 30, 1986]
[[Page 515]]
[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: 21CFR184.1370]
[Page 515]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1370 Inositol.
(a) Inositol, or myo-inositol
(C6H12O6, CAS Reg. No. 87-89-8), is
cis-1,2,3,5-trans-4,6-cyclohexanehexol. It occurs naturally and is
prepared from an aqueous (0.2 percent sulfur dioxide) extract of corn
kernels by precipitation and hydrolysis of crude phytate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 150, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitations other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in special dietary foods as defined in
part 105 of this chapter at levels not to exceed current good
manufacturing practice. It may also be used in infant formula in
accordance with section 412(g) of the Act, or with regulations
promulgated under section 412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established by this section do not exist or have been waived.
[47 FR 38278, Aug. 31, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1372]
[Page 515]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1372 Insoluble glucose isomerase enzyme preparations.
(a) Insoluble glucose isomerase enzyme preparations are used in the
production of high fructose corn syrup described in Sec. 184.1866. They
are derived from recognized species of precisely classified
nonpathogenic and nontoxicogenic microorganisms, including Streptomyces
rubiginosus, Actinoplanes missouriensis, Streptomyces olivaceus,
Streptomyces olivochromogenes, and Bacillus coagulans, that have been
grown in a pure culture fermentation that produces no antibiotics. They
are fixed (rendered insoluble) for batch production with GRAS
ingredients or may be fixed for further immobilization with either GRAS
ingredients or materials approved under Sec. 173.357 of this chapter.
(b) The ingredient meets the general and additional requirements for
enzyme preparations in the Food Chemicals Codex, 3d Ed. (1981), p. 107,
which is incorporated by reference. Copies are available from the
National Academy Press, 2101 Constitution Ave. NW., Washington, DC
20418, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as an enzyme, as defined in
Sec. 170.3(o)(9) of this chapter, to convert glucose to fructose.
(2) The ingredient is used in high fructose corn syrup, at levels
not to exceed current good manufacturing practice.
[48 FR 5720, Feb. 8, 1983, as amended at 61 FR 43450, Aug. 23, 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: 21CFR184.1375]
[Page 515-516]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1375 Iron, elemental.
(a) Iron, elemental (CAS Reg. No. 7439-89-6) is metallic iron
obtained by any of the following processes: reduced iron, electrolytic
iron, and carbonyl iron.
(1) Reduced iron is prepared by reacting ground ferric oxide with
hydrogen or carbon monoxide at an elevated temperature. The process
results in a grayish-black powder, all of which should pass through a
100-mesh sieve. It is lusterless or has not more than a slight luster.
When viewed under a microscope, it appears as an amorphous powder free
from particles having a crystalline structure. It is stable in dry air.
(2) Electrolytic iron is prepared by electrodeposition. It is an
amorphous, lusterless, grayish-black powder. It is stable in dry air.
[[Page 516]]
(3) Carbonyl iron is prepared by the decomposition of iron
pentacarbonyl. It occurs as a dark gray powder. When viewed under a
microscope, it appears as spheres built up with concentric shells. It is
stable in dry air.
(b) Iron, elemental (carbonyl, electrolytic, or reduced) meets the
specifications of the Food Chemicals Codex, 3d Ed. (1981) (iron,
carbonyl, p. 151; iron, electrolytic, pp. 151-152; iron, reduced; pp.
152-153), which is incorporated by reference. Copies are available from
the National Academy Press, 2101 Constitution Ave. NW., Washington, DC
20418, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this
chapter, with no limitation other than current good manufacturing
practice. The ingredient may also be used in accordance with section
412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
350a(g)) or with regulations promulgated under section 412(a)(2) of the
act (21 U.S.C. 350a(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[53 FR 16867, May 12, 1988]
[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: 21CFR184.1386]
[Page 516]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1386 Isopropyl citrate.
(a) Isopropyl citrate is a mixture of the mono-, di-, and
triisopropyl esters of citric acid. It is prepared by esterifying citric
acid with isopropanol.
(b) The Food and Drug Administration, in cooperation with the
National Academy of Sciences, is developing food-grade specifications
for isopropyl citrate. In the interim, this ingredient must be of a
purity suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as an antioxidant as defined in
Sec. 170.3(o)(3) of this chapter; a sequestrant as defined in
Sec. 170.3(o)(26) of this chapter; and a solvent and vehicle as defined
in Sec. 170.3(o)(27) of this chapter.
(2) The ingredient is used in margarine in accordance with
Sec. 166.110 of this chapter; in nonalcoholic beverages as defined in
Sec. 170.3(n)(3) of this chapter; and in fats and oils as defined in
Sec. 170.3(n)(12) of this chapter at levels not to exceed current good
manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section, or different from those set forth in part
181 of this chapter, do not exist or have been waived.
[59 FR 63896, Dec. 12, 1994]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1387]
[Page 516-517]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1387 Lactase enzyme preparation from Candida pseudotropicalis.
(a) This enzyme preparation is derived from the nonpathogenic,
nontoxicogenic yeast C. pseudotropicalis. It contains the enzyme lactase
([beta]-D-galactoside galactohydrolase, EC 3.2.1.23), which converts
lactose to glucose and galactose. It is prepared from yeast that has
been grown by a pure culture fermentation process.
(b) The ingredient meets the general requirements and additional
requirements for enzyme preparations in the Food Chemicals Codex, 3d ed.
(1981), pp. 107-110, which are incorporated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the
National Academy Press, 2101 Constitution Ave. NW., Washington, DC
20418, or may be examined at the Center for Food Safety and Applied
Nutrition's Library, 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) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitations other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe as a
direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
[[Page 517]]
(1) The ingredient is used as an enzyme, as defined in
Sec. 170.3(o)(9) of this chapter, to convert lactose to glucose and
galactose.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Current good manufacturing practice is
limited to use of this ingredient to reduce the lactose content in milk
and milk-derived food products where food standards do not preclude such
use.
[61 FR 7704, Feb. 29, 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: 21CFR184.1388]
[Page 517]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1388 Lactase enzyme preparation from Kluyveromyces lactis.
(a) This enzyme preparation is derived from the nonpathogenic,
nontoxicogenic yeast Kluyveromyces lactis (previously named
Saccharomyces lactis). It contains the enzyme [Bgr]-galactoside
galactohydrase (CAS Reg. No. CBS 683), which converts lactose to glucose
and galactose. It is prepared from yeast that has been grown in a pure
culture fermentation and by using materials that are generally
recognized as safe or are food additives that have been approved for
this use by the Food and Drug Administration.
(b) The ingredient meets the general and additional requirements for
enzyme preparations in the Food Chemicals Codex, 3d Ed. (1981), p. 107-
110, which is incorporated by reference. Copies are available from the
National Academy Press, 2101 Constitution Ave. NW., Washington, DC
20418, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe as a
direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an enzyme as defined in
Sec. 170.3(o)(9) of this chapter to convert lactose to glucose and
galactose.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Current good manufacturing practice is to
use this ingredient in milk to produce lactase-treated milk, which
contains less lactose than regular milk, or lactose-reduced milk, which
contains at least 70 percent less lactose than regular milk.
[49 FR 47387, Dec. 4, 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: 21CFR184.1400]
[Page 517]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1400 Lecithin.
(a) Commercial lecithin is a naturally occurring mixture of the
phosphatides of choline, ethanolamine, and inositol, with smaller
amounts of othe lipids. It is isolated as a gum following hydration of
solvent-extracted soy, safflower, or corn oils. Lecithin is bleached, if
desired, by hydrogen peroxide and benzoyl peroxide and dried by heating.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 166-167, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 51150, Nov. 7, 1983]
[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: 21CFR184.1408]
[Page 517-518]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1408 Licorice and licorice derivatives.
(a)(1) Licorice (glycyrrhiza) root is the dried and ground rhizome
and root portions of Glycyrrhiza glabra or other species of Glycyrrhiza.
Licorice extract is that portion of the licorice root that is, after
maceration, extracted by boiling water. The extract can be further
purified by filtration and by treatment with acids and ethyl alcohol.
Licorice extract is sold as a liquid, paste ("block"), or spray-dried
powder.
(2) Ammoniated glycyrrhizin is prepared from the water extract of
licorice root by acid precipitation followed by neutralization with
dilute ammonia. Monoammonium glycyrrhizinate
(C42H61O16NH45H2O,
CAS Reg. No. 1407-03-0) is prepared from ammoniated
[[Page 518]]
glycyrrhizin by solvent extraction and separation techniques.
(b) The ingredients shall meet the following specifications when
analyzed:
(1) Assay. The glycyrrhizin content of each flavoring ingredient
shall be determined by the method in the Official Methods of Analysis of
the Association of Official Analytical Chemists, 13th Ed., Secs. 19.136-
19.140, which is incorporated by reference, or by methods 19.CO1 through
19.CO4 in the Journal of the Association of Official Analytical
Chemists, 65:471-472 (1982), which are also incorporated by reference.
Copies of all of these methods are available from the Association of
Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington,
VA 22201-3301, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(2) Ash. Not more than 9.5 percent for licorice, 2.5 percent for
ammoniated glycyrrhizin, and 0.5 percent for monoammonium
glycyrrhizinate on an anhydrous basis as determined by the method in the
Food Chemicals Codex, 3d Ed. (1981), p. 466, which is incorporated by
reference. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or available for inspection
at the Office of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC 20408.
(3) Acid unsoluble ash. Not more than 2.5 percent for licorice on an
anhydrous basis as determined by the method in the Food Chemicals Codex,
3d Ed. (1981), p. 466, which is incorporated by reference.
(4) Heavy metals (as Pb). Not more than 40 parts per million as
determined by method II in the Food Chemicals Codex, 3d Ed. (1981), p.
512, which is incorporated by reference.
(5) Arsenic (As). Not more than 3 parts per million as determined by
the method in the Food Chemicals Codex. 3d Ed. (1981), p. 464, which is
incorporated by reference.
(c) In accordance with Sec. 184.1(b)(2), these ingredients are used
in food only within the following specific limitations:
------------------------------------------------------------------------
Maximum level in
food (percent
Category of food glycyrrhizin Functional use
content of food)
(as served)
------------------------------------------------------------------------
Baked foods, Sec. 170.3(n)(1) of 0.05 Flavor enhancer,
this chapter. Sec. 170.3(o)(11)
of this chapter;
flavoring agent,
Sec. 170.3(o)(12)
of this chapter.
Alcoholic beverages, Sec. 0.1 Flavor enhancer,
170.3(n)(2) of this chapter. Sec. 170.3(o)(11)
of this chapter;
flavoring agent,
Sec. 170.3(o)(12)
of this chapter;
surface-active
agent, Sec.
170.3(o)(29) of
this chapter.
Nonalcoholic beverages, Sec. 0.15 Do.
170.3(n)(3) of this chapter.
Chewing gum, Sec. 170.3(n)(6) of 1.1 Flavor enhancer,
this chapter. Sec. 170.3(o)(11)
of this chapter;
flavoring agent,
Sec. 170.3(n)(12)
of this chapter.
Hard candy, Sec. 170.3(n)(25) of 16.0 Do.
this chapter.
Herbs and seasonings, Sec. 0.15 Do.
170.3(n)(26) of this chapter.
Plant protein products, Sec. 0.15 Do.
170.3(n)(33) of this chapter.
Soft candy, Sec. 170.3(n)(38) of 3.1 Do.
this chapter.
Vitamin or mineral dietary 0.5 Do.
supplements.
All other foods except sugar 0.1 Do.
substitutes, Sec. 170.3(n)(42)
of this chapter. The ingredient
is not permitted to be used as
a nonnutritive sweetener in
sugar substitutes.
------------------------------------------------------------------------
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 21044, May 22, 1985, as amended at 54 FR 24899, 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: 21CFR184.1409]
[Page 518-519]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1409 Ground limestone.
(a) Ground limestone consists essentially (not less than 94 percent)
of calcium carbonate (CaCO3) and is prepared by the crushing,
grinding, and classifying of naturally occurring limestone.
(b) The ingredient meets the specifications of the Food Chemicals
Codex,
[[Page 519]]
3d Ed. (1981), p. 173, which is incorporated by reference. Copies are
available from the National Academy Press, 2101 Constitution Ave. NW.,
Washington, DC 20418, or available for inspection at the Office of the
Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52442, Nov. 18, 1983]
[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: 21CFR184.1415]
[Page 519]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1415 Animal lipase.
(a) Animal lipase (CAS Reg. No. 9001-62-1) is an enzyme preparation
obtained from edible forestomach tissue of calves, kids, or lambs, or
from animal pancreatic tissue. The enzyme preparation may be produced as
a tissue preparation or as an aqueous extract. Its characterizing enzyme
activity is that of a triacylglycerol hydrolase (EC 3.1.1.3).
(b) The ingredient meets the general requirements and additional
requirements for enzyme preparations in the Food Chemicals Codex, 3d ed.
(1981), p. 110, which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National
Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or may
be examined at the Office of Premarket Approval (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and the
Office of the Federal Register, 800 North Capitol St., NW., suite 700,
Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as GRAS as a direct food ingredient
is based upon the following current good manufacturing practice
conditions of use:
(1) The ingredient is used as an enzyme as defined in
Sec. 170.3(o)(9) of this chapter to hydrolyze fatty acid glycerides.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
[60 FR 32911, June 26, 1995]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1420]
[Page 519]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1420 Lipase enzyme preparation derived from Rhizopus niveus.
(a) Lipase enzyme preparation contains lipase enzyme (CAS Reg. No.
9001-62-1), which is obtained from the culture filtrate resulting from a
pure culture fermentation of a nonpathogenic and nontoxigenic strain of
Rhizopus niveus. The enzyme preparation also contains diatomaceous earth
as a carrier. The characterizing activity of the enzyme, which catalyzes
the interesterification of fats and oils at the 1- and 3-positions of
triglycerides, is triacylglycerol lipase (EC 3.1.1.3).
(b) The ingredient meets the general requirements and additional
requirements for enzyme preparations in the monograph on Enzyme
Preparations in the "Food Chemicals Codex," 4th ed. (1996), pp. 133
and 134, which is incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies are available from the National Academy
Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be
examined at the Center for Food Safety and Applied Nutrition's Library,
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) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe as a
direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an enzyme as defined in
Sec. 170.3(o)(9) of this chapter for the interesterification of fats and
oils.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
[63 FR 24419, May 4, 1998]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1425]
[Page 519-520]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1425 Magnesium carbonate.
(a) Magnesium carbonate (molecular formula approximately
[[Page 520]]
(MgCO3)4[middot]Mg(OH)2[middot]5H2
O, CAS Reg. No. 39409-82-0) is also known as magnesium carbonate
hydroxide. It is a white powder formed either by adding an alkaline
carbonate (such as sodium carbonate) to a solution of magnesium sulfate
or by carbonation of a slurry of magnesium hydroxide followed by boiling
of the resulting magnesium carbonate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 177, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as an anticaking and free-flow agent as
defined in Sec. 170.3(o)(1) of this chapter; a flour treating agent as
defined in Sec. 170.3(o)(13) of this chapter; a lubricant and release
agent as defined in Sec. 170.3(o)(18) of this chapter; a nutrient
supplement as defined in Sec. 170.3(o)(20) of this chapter; a pH control
agent as defined in Sec. 170.3(o)(23) of this chapter; a processing aid
as defined in Sec. 170.3(o)(24) of this chapter; and a synergist as
defined in Sec. 170.3(o)(31) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 13558, Apr. 5, 1985; 50 FR 16080, Apr. 24, 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: 21CFR184.1426]
[Page 520]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1426 Magnesium chloride.
(a) Magnesium chloride (MgC12[middot]6H2O, CAS
Reg. No. 7786-30-3) is a colorless, deliquescent, crystalline material
that occurs naturally as the mineral bischofite. It is prepared by
dissolving magnesium oxide, hydroxide, or carbonate in aqueous
hydrochloric acid solution and crystallizing out magnesium chloride
hexahydrate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 177, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter and a nutrient supplement
as defined in Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice. The ingredient also may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the act) or with regulations promulgated under section
412(a)(2) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 13559, Apr. 5, 1985; 50 FR 16080, Apr. 24, 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: 21CFR184.1428]
[Page 520-521]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1428 Magnesium hydroxide.
(a) Magnesium hydroxide (Mg(OH)2, CAS Reg. No. 1309-42-8)
occurs naturally as the colorless, crystalline mineral brucite. It is
prepared as a white precipitate by the addition of sodium hydroxide to a
water soluble magnesium salt or by hydration of reactive grades of
magnesium oxide.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 178, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal
[[Page 521]]
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter; a pH control agent as defined in
Sec. 170.3(o)(23) of this chapter; and a processing aid as defined in
Sec. 170.3(o)(24) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 13559, Apr. 5, 1985, as amended at 64 FR 405, Jan. 5, 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: 21CFR184.1431]
[Page 521]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1431 Magnesium oxide.
(a) Magnesium oxide (MgO, CAS Reg. No. 1309-48-4) occurs naturally
as the colorless, crystalline mineral periclase. It is produced either
as a bulky white powder (light) or a relatively dense white powder
(heavy) by heating magnesium hydroxide or carbonate. Heating these
magnesium salts under moderate conditions (400 deg. to 900 deg.C for a
few hours) produces light magnesium oxide. Heating the salts under more
rigorous conditions (1200 deg.C for 12 hours) produces heavy magnesium
oxide. Light magnesium oxide is converted to heavy magnesium oxide by
sustained heating at high temperatures.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 178, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as an anticaking and free-flow agent as
defined in Sec. 170.3(o)(1) of this chapter; a firming agent as defined
in Sec. 170.3(o)(10) of this chapter; a lubricant and release agent as
defined in Sec. 170.3(o)(18) of this chapter; a nutrient supplement as
defined in Sec. 170.3(o)(20) of this chapter; and a pH control agent as
defined in Sec. 170.3(o)(23) of this chapter.
(2) The ingredient is used in foods at levels not be exceed current
good manufacturing practice. The ingredient also may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the act) or with regulations promulgated under section
412(a)(2) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 13559, Apr. 5, 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: 21CFR184.1434]
[Page 521-522]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1434 Magnesium phosphate.
(a) Magnesium phosphate includes both magnesium phosphate, dibasic,
and magnesium phosphate, tribasic. Magnesium phosphate, dibasic
(MgHPO4[middot]3H2O, CAS Reg. No. 7782-0975-094)
occurs naturally as the white, crystalline mineral newberyite. It is
prepared commercially as a precipitate formed by treating a solution of
magnesium sulfate with disodium phosphate under controlled conditions.
Magnesium phosphate, tribasic
(Mg3(PO4)2[middot]xH2O, CAS Reg. No.
7727-0987-091) may contain 4, 5, or 8 molecules of water of hydration.
It is produced as a precipitate from a solution of magnesite with
phosphoric acid.
(b) Magnesium phosphate, dibasic, meets the specifications of the
Food Chemicals Codex, 3d Ed. (1981), p. 179, which is incorporated by
reference. Magnesium phosphate, tribasic, meets the specifications of
the Food Chemicals Codex, 3d Ed. (1981), p. 180, which is incorporated
by reference. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or available for inspection
at the Office of the Federal
[[Page 522]]
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter and a pH control agent as defined in
Sec. 170.3(o)(23) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice. The ingredient also may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 13560, Apr. 5, 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: 21CFR184.1440]
[Page 522]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1440 Magnesium stearate.
(a) Magnesium stearate
(Mg(C17H34COO)2, CAS Reg. No. 557-04-0)
is the magnesium salt of stearic acid. It is produced as a white
precipitate by the addition of an aqueous solution of magnesium chloride
to an aqueous solution of sodium stearate derived from stearic acid that
is obtained from edible sources and that conforms to the requirements of
Sec. 172.860(b)(2) of this chapter.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 182, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a lubricant and release agent as
defined in Sec. 170.3(o)(18) of this chapter; a nutrient supplement as
defined in Sec. 170.3(o)(20) of this chapter; and a processing aid as
defined in Sec. 170.3(o)(24) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 13560, Apr. 5, 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: 21CFR184.1443]
[Page 522]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1443 Magnesium sulfate.
(a) Magnesium sulfate (MgSO4[middot]7H2O, CAS
Reg. No. 10034-99-8) occurs naturally as the mineral epsomite. It is
prepared by neutralization of magnesium oxide, hydroxide, or carbonate
with sulfuric acid and evaporating the solution to crystallization.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 183, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a flavor enhancer as defined in
Sec. 170.3(o)(11) of this chapter; a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter; and a processing aid as defined in
Sec. 170.3(o)(24) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 13560, Apr. 5, 1985]
[[Page 523]]
[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: 21CFR184.1443a]
[Page 523]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1443a Malt.
(a) Malt is an enzyme preparation obtained from barley which has
been softened by a series of steeping operations and germinated under
controlled conditions. It is a brown, sweet, and viscous liquid or a
white to tan powder. Its characterizing enzyme activities are [alpha]-
amylase (EC 3.2.1.1.) and [beta]-amylase (EC 3.2.1.2).
(b) The ingredient meets the general requirements and additional
requirements for enzyme preparations in the Food Chemicals Codex, 3d ed.
(1981), p. 110, which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National
Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or may
be examined at the Office of Premarket Approval (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and the
Office of the Federal Register, 800 North Capitol St., NW., suite 700,
Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as GRAS as a direct food ingredient
is based upon the following current good manufacturing practice
conditions of use:
(1) The ingredient is used as an enzyme as defined in
Sec. 170.3(o)(9) of this chapter to hydrolyze starch or starch-derived
polysaccharides.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
[60 FR 32911, June 26, 1995]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1444]
[Page 523]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1444 Maltodextrin.
(a) Maltodextrin
((C6H10O5)n, CAS Reg. No.
9050-36-6) is a nonsweet nutritive saccharide polymer that consists of
D-glucose units linked primarily by [alpha]-1-4 bonds and that has a
dextrose equivalent (D.E.) of less than 20. It is prepared as a white
powder or concentrated solution by partial hydrolysis of corn starch,
potato starch, or rice starch with safe and suitable acids and enzymes.
(b)(1) Maltodextrin derived from corn starch must be of a purity
suitable for its intended use.
(2) Maltodextrin derived from potato starch meets the specifications
of the Food Chemicals Codex, 3d ed., 3d supp. (1992), p. 125, which are
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the National Academy Press, 2101
Constitution Ave., NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capital St. NW., suite 700,
Washington, DC 20408, or at the Division of Petition Control (HFS-217),
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.
(3) Maltodextrin derived from rice starch meets the specifications
of the Food Chemicals Codex, 4th ed. (1996), pp. 239 and 240, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Center for Food Safety and Applied Nutrition's Library, 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) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 51911, Nov. 15, 1983; as amended at 60 FR 48893, Sept. 21, 1995;
63 FR 14611, Mar. 26, 1998]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1445]
[Page 523-524]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1445 Malt syrup (malt extract).
(a) Malt is the product of barley (Hordeum vulgare L.) germinated
under controlled conditions. Malt syrup and malt extract are
interchangeable terms for a viscous concentrate of water extract of
germinated barley grain, with or without added safe preservative. Malt
syrup is usually a brown, sweet, and viscous liquid containing varying
amounts of amylolytic enzymes and plant constituents. Barley is first
softened after cleaning by steeping operations and then allowed to
germinate
[[Page 524]]
under controlled conditions. The germinated grain then undergoes
processing, such as drying, grinding, extracting, filtering, and
evaporating, to produce malt syrup (malt extract) with 75 to 80 percent
solids or dried malt syrup with higher solids content.
(b) FDA is developing food-grade specifications for malt syrup (malt
extract) in cooperation with the National Academy of Sciences. In the
interim, the ingredient must be of a purity suitable for its intended
use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 51613, Nov. 10, 1983]
[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: 21CFR184.1446]
[Page 524]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1446 Manganese chloride.
(a) Manganese chloride (MnCl2[middot]4H2O, CAS
Reg. No. 7773-01-5) is a pink, translucent, crystalline product. It is
also known as manganese dichloride. It is prepared by dissolving
manganous oxide, pyrolusite ore (MnO2), or reduced manganese
ore in hydrochloric acid. The resulting solution is neutralized to
precipitate heavy metals, filtered, concentrated, and crystallized.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 186, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter.
(2) The ingredient may be used in infant formulas in accordance with
section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or
with regulations promulgated under section 412(a)(2) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 19165, May 7, 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: 21CFR184.1449]
[Page 524-525]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1449 Manganese citrate.
(a) Manganese citrate
(Mn3(C6H5O7)2,
CAS Reg. No. 1002-46-65) is a pale orange or pinkish white powder. It is
obtained by precipitating manganese carbonate from manganese sulfate and
sodium carbonate solutions. The filtered and washed precipitate is
digested first with sufficient citric acid solution to form manganous
citrate and then with sodium citrate to complete the reaction.
(b) FDA is developing food-grade specifications for manganese
citrate in cooperation with the National Academy of Sciences. In the
interim, this ingredient must be of purity suitable for its intended
use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods as defined in
Sec. 170.3(n)(1) of this chapter; nonalcoholic beverages as defined in
Sec. 170.3(n)(3) of this chapter; dairy product analogs as defined in
Sec. 170.3(n)(10) of this chapter; fish products as defined in
Sec. 170.3(n)(13) of this
[[Page 525]]
chapter; meat products as defined in Sec. 170.3(n)(29) of this chapter;
milk products as defined in Sec. 170.3(n)(31) of this chapter; and
poultry products as defined in Sec. 170.3(n)(34) of this chapter. The
ingredient may be used in infant formulas in accordance with section
412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with
regulations promulgated under section 412(a)(2) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 19166, May 7, 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: 21CFR184.1452]
[Page 525]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1452 Manganese gluconate.
(a) Manganese gluconate
(C12H22MnO14[middot]2H2O,
CAS Reg. No. 648-0953-0998) is a slightly pink colored powder. It is
obtained by reacting manganese carbonate with gluconic acid in aqueous
medium and then crystallizing the product.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 186, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods as defined in
Sec. 170.3(n)(1) of this chapter; nonalcoholic beverages as defined in
Sec. 170.3(n)(3) of this chapter; dairy product analogs as defined in
Sec. 170.3(n)(10) of this chapter; fish products as defined in
Sec. 170.3(n)(13) of this chapter; meat products as defined in
Sec. 170.3(n)(29) of this chapter; milk products as defined in
Sec. 170.3(n)(31) of this chapter; and poultry products as defined in
Sec. 170.3(n)(34) of this chapter. The ingredient may be used in infant
formulas in accordance with section 412(g) of the Federal Food, Drug,
and Cosmetic Act (the act) or with regulations promulgated under section
412(a)(2) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 19166, May 7, 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: 21CFR184.1461]
[Page 525-526]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1461 Manganese sulfate.
(a) Manganese sulfate (MnSO4[middot]H2O, CAS
Reg. No. 7785-0987-097) is a pale pink, granular, odorless powder. It is
obtained by reacting manganese compounds with sulfuric acid. It is also
obtained as a byproduct in the manufacture of hydroquinone. Other
manufacturing processes include the action of sulfur dioxide on a slurry
of manganese dioxide in sulfuric acid, and the roasting of pyrolusite
(MnO2) ore with solid ferrous sulfate and coal, followed by
leaching and crystallization.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 188, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods as defined in
Sec. 170.3(n)(1) of this chapter; nonalcoholic beverages as defined in
Sec. 170.3(n)(3) of this chapter; dairy product analogs as defined in
Sec. 170.3(n)(10) of this chapter; fish products as defined in
Sec. 170.3(n(13) of this
[[Page 526]]
chapter; meat products as defined in Sec. 170.3(n)(29) of this chapter;
milk products as defined in Sec. 170.3(n)(31) of this chapter; and
poultry products as defined in Sec. 170.3(n)(34) of this chapter.
The ingredient may be used in infant formulas in accordance with section
412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with
regulations promulgated under section 412(a)(2) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 19166, May 7, 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: 21CFR184.1472]
[Page 526-527]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1472 Menhaden oil.
(a) Menhaden oil. (1) Menhaden oil is prepared from fish of the
genus Brevoortia, commonly known as menhaden, by cooking and pressing.
The resulting crude oil is then refined using the following steps:
Storage (winterization), degumming (optional), neutralization,
bleaching, and deodorization. Winterization may separate the oil and
produce a solid fraction.
(2) Menhaden oil meets the following specifications:
(i) Color and state. Yellow liquid to white solid.
(ii) Odor. Odorless to slightly fishy.
(iii) Saponification value. Between 180 and 200 as determined by the
American Oil Chemists' Society Official Method Cd 3-25--"Saponification
Value" (reapproved 1989), which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this
publication are available from the Office of Premarket Approval, Center
for Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the Center for Food Safety and Applied
Nutrition's Library, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or at the Office of the Federal Register,
800 North Capitol St. NW., suite 700, Washington, DC.
(iv) Iodine number. Not less than 120 as determined by the American
Oil Chemists' Society Recommended Practice Cd 1d-92--"Iodine Value of
Fats and Oils, Cyclohexane--Acetic Acid Method," which is incorporated
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The
availability of this incorporation by reference is given in paragraph
(a)(2)(iii) of this section.
(v) Unsaponifiable matter. Not more than 1.5 percent as determined
by the American Oil Chemists' Society Official Method Ca 6b-53--
"Unsaponifiable Matter" (reapproved 1989), which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The
availability of this incorporation by reference is given in paragraph
(a)(2)(iii) of this section.
(vi) Free fatty acids. Not more than 0.1 percent as determined by
the American Oil Chemists' Society Official Method Ca 5a-40--"Free
Fatty Acids" (reapproved 1989), which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of
this incorporation by reference is given in paragraph (a)(2)(iii) of
this section.
(vii) Peroxide value. Not more than 5 milliequivalents per kilogram
of oil as determined by the American Oil Chemists' Society Official
Method Cd 8-53--"Peroxide Value, Acetic Acid--Chloroform Method"
(updated 1992) or Recommended Practice Cd 8b-90--"Peroxide Value,
Acetic Acid--Isooctane Method" (updated 1992), which are incorporated
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The
availability of this incorporation by reference is given in paragraph
(a)(2)(iii) of this section.
(viii) Lead. Not more than 0.1 part per million as determined by the
American Oil Chemists' Society Official Method Ca 18c-91--
"Determination of Lead by Direct Graphite Furnace Atomic Absorption
Spectrometry" (revised 1992), which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of
this incorporation by reference is given in paragraph (a)(2)(iii) of
this section.
(ix) Mercury. Not more than 0.5 part per million as determined by
the method entitled "Biomedical Test Materials Program: Analytical
Methods for the Quality Assurance of Fish Oil," published in the "NOAA
Technical Memorandum NMFS-SEFC-211," F. M. Van
[[Page 527]]
Dolah and S. B. Galloway, editors, National Marine Fisheries Service, U.
S. Department of Commerce, pages 71-88, November, 1988, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given in
paragraph (a)(2)(iii) of this section.
(3) In accordance with Sec. 184.1(b)(2), the ingredient may be used
in food only within the following specific limitations:
------------------------------------------------------------------------
Maximum level of use in food
Category of food (as served)
------------------------------------------------------------------------
Cookies, crackers, Sec. 170.3(n)(1) of 5.0 percent
this chapter.
Breads, rolls (white & dark), Sec. 1.0 percent
170.3(n)(1) of this chapter.
Fruit pies, custard pies, Sec. 7.0 percent
170.3(n)(1) of this chapter.
Cakes, Sec. 170.3(n)(1) of this 10.0 percent
chapter.
Cereals, Sec. 170.3(n)(4) of this 4.0 percent
chapter.
Fats, oils, Sec. 170.3(n)(12) of this 20.0 percent
chapter, but not in infant formula.
Yogurt, Sec. 170.3(n)(31) of this 4.0 percent
chapter.
Cheese products, Sec. 170.3(n)(5) of 5.0 percent
this chapter.
Frozen dairy products, Sec. 5.0 percent
170.3(n)(20) of this chapter.
Meat products, Sec. 170.3(n)(29) of 10.0 percent
this chapter.
Egg products, Sec. 170.3(n)(11) of 5.0 percent
this chapter.
Fish products, Sec. 170.3(n)(13) of 20.0 percent
this chapter.
Condiments, Sec. 170.3(n)(8) of this 5.0 percent
chapter.
Soup mixes, Sec. 170.3(n)(40) of this 3.0 percent
chapter.
Snack foods, Sec. 170.3(n)(37) of this 5.0 percent
chapter.
Nut products, Sec. 170.3(n)(32) of 5.0 percent
this chapter.
Gravies, sauces, Sec. 170.3(n)(24) of 5.0 percent
this chapter.
------------------------------------------------------------------------
(b) Hydrogenated and partially hydrogenated menhaden oils. (1)
Partially hydrogenated and hydrogenated menhaden oils are prepared by
feeding hydrogen gas under pressure to a converter containing crude
menhaden oil and a nickel catalyst. The reaction is begun at 150 to 160
deg.C and after 1 hour the temperature is raised to 180 deg.C until the
desired degree of hydrogenation is reached. Hydrogenated menhaden oil is
fully hydrogenated.
(2) Partially hydrogenated and hydrogenated menhaden oils meet the
following specifications:
(i) Color. Opaque white solid.
(ii) Odor. Odorless.
(iii) Saponification value. Between 180 and 200.
(iv) Iodine number. Not more than 119 for partially hydrogenated
menhaden oil and not more than 10 for fully hydrogenated menhaden oil.
(v) Unsaponifiable matter. Not more than 1.5 percent.-
(vi) Free fatty acids. Not more than 0.1 percent.
(vii) Peroxide value. Not more than 5 milliequivalents per kilogram
of oil.
(viii) Nickel. Not more than 0.5 part per million.
(ix) Mercury. Not more than 0.5 part per million.
(x) Arsenic (as As). Not more than 0.1 part per million.
(xi) Lead. Not more than 0.1 part per million.
(3) Partially hydrogenated and hydrogenated menhaden oils are used
as edible fats or oils, as defined in Sec. 170.3(n)(12) of this chapter,
in food at levels not to exceed current good manufacturing practice.
(4) If the fat or oil is fully hydrogenated, the name to be used on
the label of a product containing it shall include the term
"hydrogenated," or if it is partially hydrogenated, the name shall
include the term "partially hydrogenated," in accordance with
Sec. 101.4(b)(14) of this chapter.
[62 FR 30756, June 5, 1997]
[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: 21CFR184.1490]
[Page 527-528]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1490 Methylparaben.
(a) Methylparaben is the chemical methyl p-hydroxybenzoate. It is
produced by the methanol esterification of p-hydroxybenzoic acid in the
presence of sulfuric acid, with subsequent distillation.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), p. 199, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as an antimicrobial agent as defined in
Sec. 170.3(o)(2) of this chapter.
[[Page 528]]
(d) The ingredient is used in food at levels not to exceed good
manufacturing practices. Current good manufacturing practice results in
a maximum level of 0.1 percent in food.
(e) Prior sanctions for this ingredient different from the uses
established in this regulation do not exist or have been waived.
[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 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: 21CFR184.1498]
[Page 528]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1498 Microparticulated protein product.
(a) Microparticulated protein product is prepared from egg whites or
milk protein or a combination of egg whites and milk protein. These
protein sources may be used alone or in combination with other safe and
suitable ingredients to form the microparticulated product. The mixture
of ingredients is high-shear heat processed to achieve a smooth and
creamy texture similar to that of fat. Safe and suitable ingredients
used in the preparation of the microparticulated protein product must be
used in compliance with the limitations of the appropriate regulations
in parts 172, 182, and 184 of this chapter.
(b) The ingredient is used in food in accordance with
Sec. 184.1(b)(2) at levels not to exceed current good manufacturing
practice. The affirmation of the use of this ingredient as generally
recognized as safe (GRAS) as a direct human food ingredient is based
upon the following conditions of use:
(1) The ingredient is used in food as a thickener as defined in
Sec. 170.3(o)(28) of this chapter or as a texturizer as defined in
Sec. 170.3(o)(32) of this chapter.
(2) The ingredient is used in frozen dessert-type products except
that the ingredient may not be used to replace the milk fat required in
standardized frozen desserts.
(3) The name of the ingredient used in the ingredient statement on
both bulk and packaged food must include the source of the protein
(e.g., "microparticulated egg white protein"), followed by a
parenthetical listing of each of the ingredients in the
microparticulated protein product, in descending order of predominance.
Microparticulated protein product must be used in accordance with this
requirement or its addition to food will be considered by FDA to
constitute the use of an unapproved food additive (see
Sec. 184.1(b)(2)).
[55 FR 6391, Feb. 23, 1990]
[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: 21CFR184.1505]
[Page 528-529]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1505 Mono- and diglycerides.
(a) Mono- and diglycerides consist of a mixture of glyceryl mono-
and diesters, and minor amounts of triesters, that are prepared from
fats or oils or fat-forming acids that are derived from edible sources.
The most prevalent fatty acids include lauric, linoleic, myristic,
oleic, palmitic, and stearic. Mono- and diglycerides are manufactured by
the reaction of glycerin with fatty acids or the reaction of glycerin
with triglycerides in the presence of an alkaline catalyst. The products
are further purified to obtain a mixture of glycerides, free fatty
acids, and free glycerin that contains at least 90 percent-by-weight
glycerides.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 201, which is incorporated by reference in
accordance with 5 U.S.C. 552(a). Copies are available from the National
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20005.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used in food as a dough strengthener as
defined in Sec. 170.3(o)(6) of this chapter; an emulsifier and
emulsifier salt as defined in Sec. 170.3(o)(8) of this chapter; a
flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this
chapter; a formulation aid as defined in Sec. 170.3(o)(14) of this
chapter; a lubricant and release agent as defined in Sec. 170.3(o)(18)
of this chapter; a solvent and vehicle as defined in Sec. 170.3(o)(27)
of this chapter; a stabilizer and thickener as defined in
Sec. 170.3(o)(28) of this chapter; a surface-
[[Page 529]]
active agent as defined in Sec. 170.3(o)(29) of this chapter; a surface-
finishing agent as defined in Sec. 170.3(o)(30) of this chapter; and a
texturizer as defined in Sec. 170.3(o)(32) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[54 FR 7403, Feb. 21, 1989, as amended at 57 FR 10616, Mar.27, 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: 21CFR184.1521]
[Page 529]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1521 Monosodium phosphate derivatives of mono- and diglycerides.
(a) Monosodium phophate derivatives of mono- and diglycerides are
composed of glyceride derivatives formed by reacting mono- and
diglycerides that are derived from edible sources with phosphorus
pentoxide (tetraphosphorus decoxide) followed by neutralization with
sodium carbonate.
(b) FDA is developing food-grade specifications for monosodium
phosphate mono- and diglycerides in cooperation with the National
Academy of Sciences. In the interim, this ingredient must be of a purity
suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used in food as an emulsifier and emulsifier
salt as defined in Sec. 170.3(o)(8) of this chapter, a lubricant and
release agent as defined in Sec. 170.3(o)(18) of this chapter, and as a
surface-active agent as defined in Sec. 170.3(o)(29) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: dairy product analogs as
defined in Sec. 170.3(n)(10) of this chapter and soft candy as defined
in Sec. 170.3(n)(38) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[54 FR 7404, Feb. 21, 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: 21CFR184.1530]
[Page 529]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1530 Niacin.
(a) Niacin (C6H5NO2, CAS Reg. No.
59-67-6) is the chemical 3-pyridinecarboxylic acid (nicotinic acid). It
is a non-hygroscopic, stable, white, crystalline solid that sublimes
without decomposition at about 230 deg.C. It is soluble in water and
alcohol. It is insoluble in ether.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 4th ed. (1996), p. 264, 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) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice. The ingredient may also be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the Act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. 2, 1983, as amended at 64
FR 1760, Jan. 12, 1999]
[[Page 530]]
[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: 21CFR184.1535]
[Page 530]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1535 Niacinamide.
(a) Niacinamide (C6H6N2O, CAS Reg.
No. 98-92-0) is the chemical 3-pyridinecarboxylic acid amide
(nicotinamide). It is a white crystalline powder that is soluble in
water, alcohol, ether, and glycerol. It melts between 128 deg. and 131
deg.C.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 205, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice. The ingredient may also be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. 2, 1983]
[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: 21CFR184.1537]
[Page 530]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1537 Nickel.
(a) Elemental nickel (CAS Reg. No. 7440-02-0) is obtained from
nickel ore by transforming it to nickel sulfide
(Ni3S2). The sulfide is roasted in air to give
nickel oxide (NiO). The oxide is then reduced with carbon to give
elemental nickel.
(b) The Food and Drug Administration is developing food-grade
specifications for nickel in cooperation with the National Academy of
Sciences. In the interim, this ingredient must be of a purity suitable
for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a catalyst as defined in
Sec. 170.3(o)(24) of this chapter.
(2) The ingredient is used in the hydrogenation of fats and oils as
defined in Sec. 170.3(n)(12) of this chapter at levels not to exceed
current good manufacturing practice. Current good manufacturing practice
includes the removal of nickel from fats and oils following
hydrogenation.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 51618, Nov. 10, 1983]
[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: 21CFR184.1538]
[Page 530-531]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1538 Nisin preparation.
(a) Nisin preparation is derived from pure culture fermentations of
certain strains of Streptococcus lactis Lancefield Group N. Nisin
preparation contains nisin (CAS Reg. No. 1414-45-5), a group of related
peptides with antibiotic activity.
(b) The ingredient is a concentrate or dry material that meets the
specifications that follow when it is tested as described in
"Specifications for Identity and Purity of Some Antibiotics," World
Health Organization, FAO Nutrition Meeting Report Series, No. 45A, 1969,
which is incorporated by reference. Copies are available from the
Dockets Management Branch (HFA-305), Food and Drug Administration, rm.
1-23, 12420 Parklawn Dr., Rockville, MD 20857, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(1) Nisin content, not less than 900 international units per
milligram.
(2) Arsenic, not more than 1 part per million.
(3) Lead, not more than 2 parts per million.
[[Page 531]]
(4) Zinc, not more than 25 parts per million.
(5) Copper, zinc plus copper not more than 50 parts per million.
(6) Total plate count, not more than 10 per gram.
(7) Escherichia coli, absent in 10 grams.
(8) Salmonella, absent in 10 grams.
(9) Coagulase positive staphylococci, absent in 10 grams.
(c) The ingredient is used as an antimicrobial agent as defined in
Sec. 170.3(o)(2) of this chapter to inhibit the outgrowth of Clostridium
botulinum spores and toxin formation in pasteurized cheese spreads and
pasteurized process cheese spreads listed in Sec. 133.175; pasteurized
cheese spread with fruits, vegetables, or meats as defined in
Sec. 133.176; pasteurized process cheese spread as defined in
Sec. 133.179; pasteurized process cheese spread with fruits, vegetables,
or meats as defined in Sec. 133.180 of this chapter.
(d) The ingredient is used at levels not to exceed good
manufacturing practice in accordance with Sec. 184.1(b)(1) of this
chapter. The current good manufacturing practice level is the quantity
of the ingredient that delivers a maximum of 250 parts per million of
nisin in the finished product as determined by the British Standards
Institution Methods, "Methods for the Estimation and Differentiation of
Nisin in Processed Cheese," BS 4020 (1974), which is incorporated by
reference. Copies are available from the Dockets Management Branch (HFA-
305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857, or available for inspection at the Office of the
Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
DC 20408.
[53 FR 11250, Apr. 6, 1988, as amended at 59 FR 14364, Mar. 28, 1994]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1540]
[Page 531]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1540 Nitrogen.
(a) Nitrogen (empirical formula N2, CAS Reg. No. 7727-37-
9) is a colorless, odorless, flavorless gas that is produced
commercially by the fractionation of liquid air.
(b) The Food and Drug Administration is developing food-grade
specifications for nitrogen in cooperation with the National Academy of
Sciences. In the interim, the ingredient must be of a purity suitable
for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitations other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a propellant, aerating agent, and gas
as defined in Sec. 170.3(o)(25) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 57270, Dec. 29, 1983]
[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: 21CFR184.1545]
[Page 531-532]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1545 Nitrous oxide.
(a) Nitrous oxide (empirical formula N2O, CAS Reg. No.
10024-97-2) is also known as dinitrogen monoxide or laughing gas. It is
a colorless gas, about 50 percent heavier than air, with a slightly
sweet smell. It does not burn but will support combustion. Nitrous oxide
is manufactured by the thermal decomposition of ammonium nitrate. Higher
oxides of nitrogen are removed by passing the dry gas through a series
of scrubbing towers.
(b) The Food and Drug Administration is developing food-grade
specifications for nitrous oxide in cooperation with the National
Academy of Sciences. In the interim, the ingredient must be of a purity
suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitations other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a propellant, aerating agent, and gas
as defined in Sec. 170.3(o)(25) of this chapter.
(2) The ingredient is used in dairy product analogs as defined in
Sec. 170.3(n)(10) of this chapter at levels
[[Page 532]]
not to exceed current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 57270, Dec. 29, 1983]
[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: 21CFR184.1553]
[Page 532]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1553 Peptones.
(a) Peptones are a variable mixture of polypeptides, oligopeptides,
and amino acids that are produced by partial hydrolysis of casein,
animal tissue, soy protein isolate, gelatin, defatted fatty tissue, egg
albumin, or lactalbumin (whey protein). Peptones are produced from these
proteins using proteolytic enzymes that either are considered to be
generally recognized as safe (GRAS) or are regulated as food additives.
Peptones are also produced by denaturing any of the proteins listed in
this paragraph with safe and suitable acids or heat.
(b) FDA is developing food-grade specifications for peptones in
cooperation with the National Academy of Sciences. In the interim, these
ingredients must be of a purity suitable for their intended use.
(c) In accordance with Sec. 184.1(b)(1), these ingredients are used
in food with no limitation other than current good manufacturing
practice. The affirmation of these ingredients as GRAS as direct human
food ingredients is based upon the following current good manufacturing
practice conditions of use:
(1) These ingredients are used as nutrient supplements as defined in
Sec. 170.3(o)(20) of this chapter; as processing aids as defined in
Sec. 170.3(o)(24) of this chapter; and as surface-active agents as
defined in Sec. 170.3(o)(29) of this chapter.
(2) These ingredients are used in food at levels not to exceed
current good manufacturing practice.
(d) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
[49 FR 25430, June 21, 1984, as amended at 50 FR 49536, Dec. 3, 1985]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1555]
[Page 532-533]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1555 Rapeseed oil.
(a) Fully hydrogenated rapeseed oil. (1) Fully hydrogenated rapeseed
oil is a mixture of triglycerides in which the fatty acid composition is
a mixture of saturated fatty acids. The fatty acids are present in the
same porportions which result from the full hydrogenation of fatty acids
occurring in natural rapeseed oil. The rapeseed oil is obtained from the
napus and campestris varieties of Brassica of the family Cruciferae. It
is prepared by fully hydrogenating refined and bleached rapeseed oil at
310-375 deg.F, using a catalyst such as nickel, until the iodine number
is 4 or less.
(2) The ingredient meets the following specifications: Acid value
not more than 6, arsenic not more than 3 parts per million, free
glycerin not more than 7 percent, heavy metals (as Pb) not more than 10
parts per million, iodine number not more than 4, residue on ignition
not more than 0.5 percent.
(3) The ingredient is used as a stabilizer and thickener as defined
in Sec. 170.3(o)(28) of this chapter in peanut butter. The use level of
the ingredient is limited by good manufacturing practice (GMP) to the
minimum amount required to produce the intended effect. Current good
manufacturing practices result in a maximum level of 2 percent in peanut
butter.
(b) Superglycerinated fully hydrogenated rapeseed oil. (1)
Superglycerinated fully hydrogenated rapeseed oil is a mixture of mono-
and diglycerides with triglycerides as a minor component. The fatty acid
composition is a mixture of saturated fatty acids present in the same
proportions as those resulting from the full hydrogenation of fatty
acids in natural rapeseed oil. It is made by adding excess glycerol to
the fully hydrogenated rapeseed oil and heating, in the presence of a
sodium hydroxide catalyst, to 330 deg.F under partial vacuum and steam
sparging agitation.
(2) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), p. 201, relating to mono- and diglycerides,
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.,
[[Page 533]]
suite 700, Washington, DC 20408. An additional specification requires
the iodine number to be 4 or less.
(3) The ingredient is used as an emulsifier as defined in
Sec. 170.3(o)(8) of this chapter in shortenings for cake mixes. The use
level of the ingredient is limited by good manufacturing practice (GMP)
to the minimum amount required to produce the intended effect. Current
good manufacturing practices result in a maximum level, as served, of 4
percent of the shortening or 0.5 percent of the total weight of the cake
mix.
(c) Low erucic acid rapeseed oil. (1) Low erucic acid rapeseed oil,
also known as canola oil, is the fully refined, bleached, and deodorized
edible oil obtained from certain varieties of Brassica Napus or B.
Campestris of the family Cruciferae. The plant varieties are those
producing oil-bearing seeds with a low erucic acid content. Chemically,
low erucic acid rapeseed oil is a mixture of triglycerides, composed of
both saturated and unsaturated fatty acids, with an erucic acid content
of no more than 2 percent of the component fatty acids.
(2) Low erucic acid rapeseed oil as defined in paragraph (c)(1) of
this section may be partially hydrogenated to reduce the proportion of
unsaturated fatty acids. When the partially hydrogenated low erucic acid
rapeseed oil is used, it shall be referred to as partially hydrogenated
low erucic acid rapeseed oil.
(3) In addition to limiting the content of erucic acid to a level
not exceeding 2 percent of the component fatty acids, FDA is developing
other food-grade specifications for low erucic acid rapeseed oil and
partially hydrogenated low erucic acid rapeseed oil in cooperation with
the National Academy of Sciences. In the interim, the ingredients must
be of a purity suitable for their intended use.
(4) Low erucic acid rapeseed oil and partially hydrogenated low
erucic acid rapeseed oil are used as edible fats and oils in food,
except in infant formula, at levels not to exceed current good
manufacturing practice.
[42 FR 48336, Sept. 23, 1977, as amended at 49 FR 5613, Feb. 14, 1984;
50 FR 3755, Jan. 28, 1985; 53 FR 52682, Dec. 29, 1988]
[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: 21CFR184.1560]
[Page 533]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1560 Ox bile extract.
(a) Ox bile extract (CAS Reg. No. 8008-63-7), also known as purified
oxgall or sodium choleate, is a yellowish green, soft solid, with a
partly sweet, partly bitter, disagreeable taste. It is the purified
portion of the bile of an ox obtained by evaporating the alcohol extract
of concentrated bile.
(b) Food-grade ox bile extract shall meet the specifications of the
U.S. Pharmacopeia (USP), XIV, 1950, p. 410. \1\
---------------------------------------------------------------------------
\1\ Copies may be obtained from: U.S. Pharmacopeial Convention,
Inc., 12601 Twinbrook Parkway, Rockville, MD 20852.
---------------------------------------------------------------------------
(c) The ingredient is used as a surfactant as defined in Sec. 170.3
(o)(29) of this chapter.
(d) The ingredient is used in food in accordance with
Sec. 184.1(b)(1) at levels not to exceed good manufacturing practice.
Current good manufacturing practice results in a maximum level, as
served, of 0.002 percent for cheese as defined in Sec. 170.3(n)(5) of
this chapter.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[43 FR 36064, Aug. 15, 1978. Redesignated and amended at 50 FR 49537,
Dec. 3, 1985]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1563]
[Page 533-534]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1563 Ozone.
(a) Ozone (O3, CAS Reg. No. 10028-15-6) is an unstable
blue gas with a pungent, characteristic odor, which occurs freely in
nature, It is produced commercially by passing electrical discharges or
ionizing radiation through air or oxygen.
(b) The ingredient must be of a purity suitable for its intended use
in accordance with Sec. 170.30(h)(1) of this chapter.
(c) In accordance with Sec. 184.1(b)(2), the ingredient is used to
treat food only within the following specific limitations:
[[Page 534]]
------------------------------------------------------------------------
Maximum treatment
Category of food level in food Functional use
------------------------------------------------------------------------
Bottled water that prior to Not to exceed Antimicrobial
ozonation meets the current good agent, Sec.
microbiological, physical, manufacturing 170.3 (o)(2) of
chemical, and radiological practice. Current this chapter.
quality standards of Sec. good manufacturing
165.110 (b)(2) through (b)(5) practice results
of this chapter. in a maximum
residual level at
the time of
bottling of 0.4
milligram of ozone
per liter of
bottled water.
------------------------------------------------------------------------
[47 FR 50210, Nov. 5, 1982, as amended at 60 FR 57130, Nov. 13, 1995]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1583]
[Page 534]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1583 Pancreatin.
(a) Pancreatin (CAS Reg. No. 8049-47-6) is an enzyme preparation
obtained from porcine or bovine pancreatic tissue. It is a white to tan
powder. Its characterizing enzyme activity that of a peptide hydrolase
(EC 3.4.21.36).
(b) The ingredient meets the general requirements and additional
requirements in the Food Chemicals Codex, 3d ed. (1981), p. 110, which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of Premarket Approval (HFS-200), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, and the Office of the
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as GRAS as a direct food ingredient
is based upon the following current good manufacturing practice
conditions of use:
(1) The ingredient is used as an enzyme as defined in
Sec. 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
[60 FR 32911, June 26, 1995]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1585]
[Page 534]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1585 Papain.
(a) Papain (CAS Reg. No. 9001-73-4) is a proteolytic enzyme derived
from Carica papaya L. Crude latex containing the enzyme is collected
from slashed unripe papaya. The food-grade product is obtained by
repeated filtration of the crude latex or an aqueous solution of latex
or by precipitation from an aqueous solution of latex. The resulting
enzyme preparation may be used in a liquid or dry form.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 107-110, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than currect good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing conditions of use:
(1) The ingredient is used as an enzyme as defined in
Sec. 170.3(o)(9) of this chapter; processing aid as defined in
Sec. 170.3(o)(24) of this chapter; and texturizer as defined in
Sec. 170.3(o)(32) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 48806, Oct. 21, 1983]
[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: 21CFR184.1588]
[Page 534-535]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1588 Pectins.
(a) The pectins (CAS Reg. No. 9000-69-5) are a group of complex,
high molecular weight polysaccharides found in plants and composed
chiefly of partially methylated polygalacturonic acid units. Portions of
the carboxly group occur as methyl esters, and the remaining carboxyl
groups exist in the form of the free acid or as its ammonium, potassium,
or sodium (CAS Reg. No. 9000-59-8) salts, and in some types
[[Page 535]]
as the acid amide. Thus, the pectins regulated in this section are the
high-ester pectins, low-ester pectins, amidated pectins, pectinic acids,
and pectinates. Pectin is produced commercially by extracting citrus
peel, apple pomace, or beet pulp with hot dilute acid (pH 1.0 to 3.5,
70 deg. to 90 deg.C). The extract is filtered, and pectin is then
precipitated from the clear extract with ethanol or isopropanol, or as
the copper or aluminum salt. The acid extract is sometimes spray- or
roller-dried, or it is concentrated to be sold as liquid pectin.
(b) The ingredients meet the specifications of the Food Chemical
Codex, 3d Ed. (1981), p. 215, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredients are used in
food with no limitation other than current good manufacturing practice.
The affirmation of these ingredients as generally recognized as safe
(GRAS) as direct human food ingredients is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredients are used as emulsifiers as defined in
Sec. 170.3(o)(8) of this chapter and as stabilizers and thickeners as
defined in Sec. 170.3(o)(28) of this chapter.
(2) The ingredients are used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
[48 FR 51149, Nov. 7, 1983]
[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: 21CFR184.1595]
[Page 535]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1595 Pepsin.
(a) Pepsin (CAS Reg. No. 9001-75-6) is an enzyme preparation
obtained from the glandular layer of hog stomach. It is a white to light
tan powder, amber paste, or clear amber to brown liquid. Its
characterizing enzyme activity is that of a peptide hydrolase (EC
3.4.23.1).
(b) The ingredient meets the general requirements and additional
requirements for enzyme preparations in the Food Chemicals Codex, 3d ed.
(1981), p. 110, which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may
be examined at the Office of Premarket Approval (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and the
Office of the Federal Register, 800 North Capitol St. NW., suite 700,
Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as GRAS as a direct food ingredient
is based upon the following current good manufacturing practice
conditions of use:
(1) The ingredient is used as an enzyme as defined in
Sec. 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
[60 FR 32911, June 26, 1995]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1610]
[Page 535-536]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1610 Potassium alginate.
(a) Potassium alginate (CAS Reg. No. 9005-36-1) is the potassium
salt of alginic acid, a natural polyuronide constituent of certain brown
algae. Potassium alginate is prepared by the neutralization of purified
alginic acid with appropriate pH control agents.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 239, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(2), the ingredient is used in
food only within the following specific limitations:
[[Page 536]]
------------------------------------------------------------------------
Maximum
level of
use in
Category of food food (as Functional use
served)
(percent)
------------------------------------------------------------------------
Confections and frostings, Sec. 0.1 Stabilizer, thickener,
170.3(n)(9) of this chapter. Sec. 170.3(o)(28) of
this chapter
Gelatins and puddings, Sec. 0.7 Do.
170.3(n)(22) of this chapter.
Processed fruits and fruit juices, 0.25 Do.
Sec. 170.3(n)(35) of this chapter.
All other food categories........... 0.01 Do.
------------------------------------------------------------------------
(d) Prior sanctions for potassium alginate different from the uses
established in this section do not exist or have been waived.
[47 FR 29951, July 9, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1613]
[Page 536]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1613 Potassium bicarbonate.
(a) Potassium bicarbonate (KHCO3, CAS Reg. No. 298-14-6)
is made by the following processes:
(1) By treating a solution of potassium hydroxide with carbon
dioxide;
(2) By treating a solution of potassium carbonate with carbon
dioxide.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 239, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a formulation aid as defined in
Sec. 170.3(o)(14) of this chapter; nutrient supplemlent as defined in
Sec. 170.3(o)(20) of this chapter; pH control agent as defined in
Sec. 170.3(o)(23) of this chapter; and processing aid as defined in
Sec. 170.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52442, Nov. 18, 1983]
[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: 21CFR184.1619]
[Page 536-537]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1619 Potassium carbonate.
(a) Potassium carbonate (K2CO3, CAS Reg. No.
584-08-7) is produced by the following methods of manufacture:
(1) By electrolysis of potassium chloride followed by exposing the
resultant potassium to carbon dioxide;
(2) By treating a solution of potassium hydroxide with excess carbon
dioxide to produce potassium carbonate;
(3) By treating a solution of potassium hydroxide with carbon
dioxide to produce potassium bicarbonate, which is then heated to yield
potassium carbonate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 240, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, D.C. 20418, or available for inspection at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
the affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used in food as a flavoring agent and adjuvant
as defined in Sec. 170.3(o)(12) of this chapter; nutrient supplement as
defined in Sec. 170.3(o)(20) of this chapter; pH control agent as
defined in Sec. 170.3(o)(23) of this chapter; and processing aid as
defined in Sec. 170.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in
[[Page 537]]
this section do not exist or have been waived.
[48 FR 52442, Nov. 18, 1983]
[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: 21CFR184.1622]
[Page 537]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1622 Potassium chloride.
(a) Potassium chloride (KCl, CAS Reg. No. 7447-40-7) is a white,
odorless solid prepared from source minerals by fractional
crystallization or flotation. It is soluble in water and glycerol and
has a saline taste at low concentration levels.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 241, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a flavor enhancer as defined in
Sec. 170.3(o)(11) of this chapter; as a flavoring agent as defined in
Sec. 170.3(o)(12) of this chapter; as a nutrient supplement as defined
in Sec. 170.3(o)(20) of this chapter; as a pH control agent as defined
in Sec. 170.3(o)(23) of this chapter; and as a stabilizer or thickener
as defined in Sec. 170.3(o)(28) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Potassium chloride may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the Act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 51614, Nov. 10, 1983]
[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: 21CFR184.1625]
[Page 537]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1625 Potassium citrate.
(a) Potassium citrate
(C6H5K3O7[middot]H2
O, CAS Reg. No. 006100-0905-096) is the potassium salt of citric acid.
It is prepared by neutralizing citric acid with potassium hydroxide or
potassium carbonate. It occurs as transparent crystals or a white
granular powder, is odorless and deliquescent, and contains one mole of
water per mole of potassium citrate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d ed. (1981), p. 242, which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available
from the National Academy Press, 2101 Constitution Ave. NW., Washington,
DC 20418, and the Center for Food Safety and Applied Nutrition (HFS-
200), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be
examined at the Office of the Federal Register, 800 North Capitol St.
NW., suite 700, Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section, or different from those set forth in part
181 of this chapter, do not exist or have been waived.
[59 FR 63896, Dec. 12, 1994]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1631]
[Page 537-538]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1631 Potassium hydroxide.
(a) Potassium hydroxide (KOH, CAS Reg. No. 1310-58-3) is also known
as caustic potash, potash lye, and potassa. The empirical formula is
KOH. It is a white, highly deliquescent caustic solid, which is marketed
in several forms, including pellets, flakes, sticks, lumps, and powders.
Potassium hydroxide is obtained commercially from the electrolysis of
potassium chloride solution in the presence of a porous diaphragm.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), which is incorporated by reference. Copies are
available from the National Academy Press, 2101 Constitution Ave. NW.,
Washington, DC 20418, or available from inspection at the Office of the
Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good
[[Page 538]]
manufacturing practice. The affirmation of this ingredient as generally
recognized as safe (GRAS) as a direct human food ingredient is based
upon the following current good manufacturing practice conditions of
use:
(1) The ingredient is used as a formulation aid as defined in
Sec. 170.3(o)(14) of this chapter; a pH control agent as defined in
Sec. 170.3(o)(23) of the chapter; a processing aid as defined in
Sec. 170.3(o)(24) of this chapter; and a stabilizer and thickener as
defined in Sec. 170.3(o)(28) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52444, Nov. 18, 1983]
[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: 21CFR184.1634]
[Page 538]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1634 Potassium iodide.
(a) Potassium iodide (KI, CAS Reg. No. 7681-11-0) is the potassium
salt of hydriodic acid. It occurs naturally in sea water and in salt
deposits, but can be prepared by reacting hydriodic acid (HI) with
potassium bicarbonate (KHCO3).
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), pp. 246-247, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter.
(d) The ingredient is used in table salt in accordance with
Sec. 184.1(b)(2) of this chapter as a source of dietary iodine at a
maximum level of 0.01 percent.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[43 FR 11699, Mar. 21, 1978, as amended at 49 FR 5613, Feb. 14, 1984; 61
FR 14247, 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: 21CFR184.1635]
[Page 538]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1635 Potassium iodate.
(a) Potassium iodate (KIO3, CAS Reg. No. 7758-05-6) does
not occur naturally but can be prepared by reacting iodine with
potassium hydroxide.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), pp. 245-246, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as a dough strengthener as defined in
Sec. 170.3(o)(6) of this chapter.
(d) The ingredient is used in the manufacture of bread in accordance
with Sec. 184.1(b)(2) of this chapter in an amount not to exceed 0.0075
percent based on the weight of the flour.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[43 FR 11699, Mar. 21, 1978, as amended at 49 FR 5613, Feb. 14, 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: 21CFR184.1639]
[Page 538-539]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1639 Potassium lactate.
(a) Potassium lactate (C3H5O3K, CAS
Reg. No. 996-31-6) is the potassium salt of lactic acid. It is a
hydroscopic, white, odorless solid and is prepared commercially by the
neutralization of lactic acid with potassium hydroxide.
(b) FDA is developing food-grade specifications for potassium
lactate in cooperation with the National Academy of Sciences. In the
interim, this ingredient must be of a purity suitable for its intended
use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
This regulation does not authorize its use in infant foods and infant
formulas. The affirmation of this ingredient as generally recognized as
safe (GRAS) as a direct human food ingredient is based upon the
following current good manufacturing practice conditions of use:
(1) The ingredient is used as a flavor enhancer as defined in
Sec. 170.3(o)(11) of this chapter; a flavoring agent or adjuvant as
defined in Sec. 170.3(o)(12) of this
[[Page 539]]
chapter; a humectant as defined in Sec. 170.3(o)(16) of this chapter;
and a pH control agent as defined in Sec. 170.3(o)(23) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[52 FR 10886, Apr. 6, 1987]
[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: 21CFR184.1643]
[Page 539]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1643 Potassium sulfate.
(a) Potassium sulfate (K2SO4, CAS Reg. No.
7778-80-5) occurs naturally and consists of colorless or white crystals
or crystalline powder having a bitter, saline taste. It is prepared by
the neutralization of sulfuric acid with potassium hydroxide or
potassium carbonate.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), p. 252, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as a flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practice in accordance with Sec. 184.1(b)(1). Current good
manufacturing practice results in a maximum level, as served, of 0.015
percent for nonalcoholic beverages as defined in Sec. 170.3(n)(3) of
this chapter.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[45 FR 6086, Jan. 25, 1980, as amended at 49 FR 5613, Feb. 14, 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: 21CFR184.1655]
[Page 539]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1655 Propane.
(a) Propane (empirical formula C3H8, CAS Reg.
No. 74-98-6) is also known as dimethylmethane or propyl hydrid. It is a
colorless, odorless, flammable gas at normal temperatures and pressures.
It is easily liquefied under pressure at room temperature and is stored
and shipped in the liquid state. Propane is obtained from natural gas by
fractionation following absorption in oil, adsorption to surface-active
agents, or refrigeration.
(b) The Food and Drug Administration is developing food-grade
specifications for propane in cooperation with the National Academy of
Sciences. In the interim, the ingredient must be of a purity suitable
for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitations other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a propellant, aerating agent, and gas
as defined in Sec. 170.3(o)(25) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 57271, Dec. 29, 1983]
[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: 21CFR184.1660]
[Page 539-540]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1660 Propyl gallate.
(a) Propyl gallate is the n-propylester of 3,4,5-trihydroxybenzoic
acid (C10H12O5). Natural occurrence of
propyl gallate has not been reported. It is commercially prepared by
esterification of gallic acid with propyl alcohol followed by
distillation to remove excess alcohol.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), pp. 257-258, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as an antioxidant as defined in
Sec. 170.3(o)(3) of this chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practice in accordance with
[[Page 540]]
Sec. 184.1(b)(1). Good manufacturing practice results in a maximum total
content of antioxidants of 0.02 percent of the fat or oil content,
including the essential (volatile) oil content, of the food.
(e) Prior sanctions for this ingredient different from the uses
established in this section, or different from that stated in part 181
of this chapter, do not exist or have been waived.
[42 FR 14653, Mar. 15, 1977, as amended at 44 FR 52826, Sept. 11, 1979;
49 FR 5613, Feb. 14, 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: 21CFR184.1666]
[Page 540]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1666 Propylene glycol.
(a) Propylene glycol (C3H8O2, CAS
Reg. No. 57-55-6) is known as 1,2-propanediol. It does not occur in
nature. Propylene glycol is manufactured by treating propylene with
chlorinated water to form the chlorohydrin which is converted to the
glycol by treatment with sodium carbonate solution. It is also prepared
by heating glyercol with sodium hydroxide.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 255, which is incorporated by reference. Copies
may be obtained from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418. It is also available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as an anticaking agent as defined in
Sec. 170.3(o)(1) of this chapter; antioxidant as defined in
Sec. 170.3(o)(3) of this chapter; dough strengthener as defined in
Sec. 170.3(o)(6) of this chapter; emulsifier as defined in
Sec. 170.3(o)(8) of this chapter; flavor agent as defined in
Sec. 170.3(o)(12) of this chapter; formulation aid as defined in
Sec. 170.3(o)(14) of this chapter; humectant as defined in
Sec. 170.3(o)(16) of this chapter; processing aid as defined in
Sec. 170.3(o)(24) of this chapter; solvent and vehicle as defined in
Sec. 170.3(o)(27) of this chapter; stabilizer and thickener as defined
in Sec. 170.3(o)(28) of this chapter; surface-active agent as defined in
Sec. 170.3(o)(29) of this chapter; and texturizer as defined in
Sec. 170.3(o)(32) of this chapter.
(d) The ingredient is used in foods at levels not to exceed current
good manufacturing practice in accordance with Sec. 184.1(b)(1). Current
good manufacturing practice results in maximum levels, as served, of 5
percent for alcoholic beverages, as defined in Sec. 170.3(n)(2) of this
chapter; 24 percent for confections and frostings as defined in
Sec. 170.3(n)(9) of this chapter; 2.5 percent for frozen dairy products
as defined in Sec. 170.3(n)(20) of this chapter; 97 percent for
seasonings and flavorings as defined in Sec. 170.3(n)(26) of this
chapter; 5 percent for nuts and nut products as defined in
Sec. 170.3(n)(32) of this chapter; and 2.0 percent for all other food
categories.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[47 FR 27812, June 25, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1670]
[Page 540]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1670 Propylparaben.
(a) Propylparaben is the chemical propyl p-hydroxybenzoate. It is
produced by the n-propanol esterification of p-hydroxybenzoic acid in
the presence of sulfuric acid, with subsequent distillation.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), p. 258, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as an antimicrobial agent as defined in
Sec. 170.3(o)(2) of this chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practices. Current good manufacturing practice results in
a maximum level of 0.1 percent in food.
(e) Prior sanctions for this ingredient different from the uses
established in this regulation do not exist or have been waived.
[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 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: 21CFR184.1676]
[Page 540-541]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1676 Pyridoxine hydrochloride.
(a) Pyridoxine hydrochloride
(C8H11NO3[middot]HCl, CAS Reg. No. 58-
56-0) is the chemical 3-hydroxy-4,5-
[[Page 541]]
dihydroxymethy-2-methylpyridine hydrochloride that is prepared by
chemical synthesis.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 260, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods as defined in
Sec. 170.3(n)(1) of this chapter; nonalcoholic beverages and beverage
bases as defined in Sec. 170.3(n)(3) of this chapter; breakfast cereals
as defined in Sec. 170.3(n)(4) of this chapter; dairy product analogs as
defined in Sec. 170.3(n)(10) of this chapter; meat products as defined
in Sec. 170.3(n)(29) of this chapter; milk products as defined in
Sec. 170.3(n)(31) of this chapter; plant protein products as defined in
Sec. 170.3(n)(33) of this chapter; and snack foods as defined in
Sec. 170.3(n)(37) of this chapter. Pyridoxine hydrochloride may be used
in infant formula in accordance with section 412(g) of the Federal Food,
Drug, and Cosmetic Act (the Act) or with regulations promulgated under
section 412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 51615, Nov. 10, 1983]
[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: 21CFR184.1685]
[Page 541-542]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1685 Rennet (animal-derived) and chymosin preparation (fermentation-derived).
(a)(1) Rennet and bovine rennet are commercial extracts containing
the active enzyme rennin (CAS Reg. No. 9001-98-3), also known as
chymosin (International Union of Biochemistry Enzyme Commission (E.C.)
3.4.23.4). Rennet is the aqueous extract prepared from cleaned, frozen,
salted, or dried fourth stomachs (abomasa) of calves, kids, or lambs.
Bovine rennet is the product from adults of the animals listed above.
Both products are called rennet and are clear amber to dark brown liquid
preparations or white to tan powders.
(2) Chymosin preparation is a clear solution containing the active
enzyme chymosin (E.C. 3.4.23.4). It is derived, via fermentation, from a
nonpathogenic and nontoxigenic strain of Escherichia coli K-12
containing the prochymosin gene. The prochymosin is isolated as an
insoluble aggregate that is acid-treated to destroy residual cellular
material and, after solubilization, is acid-treated to form chymosin. It
must be processed with materials that are generally recognized as safe,
or are food additives that have been approved by the Food and Drug
Administration for this use.
(3) Chymosin preparation is a clear solution containing the active
enzyme chymosin (E.C. 3.4.23.4). It is derived, via fermentation, from a
nonpathogenic and nontoxigenic strain of Kluyveromyces marxianus variety
lactis, containing the prochymosin gene. The prochymosin is secreted by
cells into fermentation broth and converted to chymosin by acid
treatment. All materials used in the processing and formulating of
chymosin must be either generally recognized as safe (GRAS), or be food
additives that have been approved by the Food and Drug Administration
for this use.
(4) Chymosin preparation is a clear solution containing the active
enzyme chymosin (E.C. 3.4.23.4). It is derived, via fermentation, from a
nonpathogenic and nontoxigenic strain of Aspergillus niger van Tieghem
variety awamori (Nakazawa) Al-Musallam (synonym A. awamori Nakazawa)
containing the prochymosin gene. Chymosin is recovered from the
fermentation broth after acid treatment. All materials used in the
processing
[[Page 542]]
and formulating of chymosin preparation must be either generally
recognized as safe (GRAS) or be food additives that have been approved
by the Food and Drug Administration for this use.
(b) Rennet and chymosin preparation meet the general and additional
requirements for enzyme preparations of the "Food Chemicals Codex," 3d
Ed. (1981), pp. 107-110, which is incorporated by reference in
accordance with 5 U.S.C. 552(a). Copies are available from the National
Academy Press, 2101 Constitution Avenue NW., Washington, DC 20418, or
are available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe as a
direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an enzyme as defined in
Sec. 170.3(o)(9) of this chapter; a processing aid as defined in
Sec. 170.3(o)(24) of this chapter; and a stabilizer and thickener as
defined in Sec. 170.3(o)(28) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: In cheeses as defined in
Sec. 170.3(n)(5) of this chapter; frozen dairy desserts and mixes as
defined in Sec. 170.3(n)(20) of this chapter; gelatins, puddings, and
fillings as defined in Sec. 170.3(n)(22) of this chapter; and milk
products as defined in Sec. 170.3(n)(31) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[55 FR 10935, Mar. 23, 1990, as amended at 57 FR 6479, Feb. 25, 1992; 58
FR 27202, May 7, 1993]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1695]
[Page 542]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1695 Riboflavin.
(a) Riboflavin
(C17H20N4O6, CAS Reg. No.
83-88-5) occurs as yellow to orange-yellow needles that are crystallized
from 2N acetic acid, alcohol, water, or pyridine. It may be prepared by
chemical synthesis, biosynthetically by the organism Eremothecium
ashbyii, or isolated from natural sources.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 262, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice. The ingredient may also be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the Act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 51148, Nov. 7, 1983]
[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: 21CFR184.1697]
[Page 542-543]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1697 Riboflavin-5'-phosphate (sodium).
(a) Riboflavin-5'-phosphate (sodium)
(C17H20N4O9PNa[middot]2H2
O, CAS Reg. No 130-40-5) occurs as the dihydrate in yellow to orange-
yellow crystals. It is prepared by phosphorylation of riboflavin with
chlorophosphoric acid, pyrophosphoric acid, metaphosphoric acid, or
pyrocatechol cyclic phosphate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 263, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
[[Page 543]]
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in milk products, as defined in
Sec. 170.3(n)(31) of this chapter, at levels not to exceed current good
manufacturing practice. The ingredient may also be used in infant
formulas in accordance with section 412(g) of the Federal Food, Drug,
and Cosmetic Act (the Act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 51148, Nov. 7, 1983]
[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: 21CFR184.1698]
[Page 543]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1698 Rue.
(a) Rue is the perennial herb of several species of Ruta (Ruta
montana L., Ruta graveolens L., Ruta bracteosa L., and Ruta calepensis
L.). The leaves, buds, and stems from the top of the plant are gathered,
dried, and then crushed in preparation for use, or left whole.
(b) The ingredient is used in all categories of food in accordance
with Sec. 184.1(b)(2) of this chapter at concentrations not to exceed 2
parts per million.
(c) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[43 FR 3705, Jan. 27, 1978]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1699]
[Page 543]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1699 Oil of rue.
(a) Oil of rue is the natural substance obtained by steam
distillation of the fresh blossoming plants of rue, the perennial herb
of several species of Ruta--Ruta montana L., Ruta graveolens L., Ruta
bracteosa L., and Ruta calepensis L.
(b) Oil of rue meets the specifications of the "Food Chemicals
Codex," 4th ed. (1996), pp. 342-343, which is incorporated by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are
available from the National Academy Press, Box 285, 2101 Constitution
Ave. NW., Washington, DC 20055 (Internet address "http://
www.nap.edu"), or may be examined at the Center for Food Safety and
Applied Nutrition's Library, Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or at the Office of the Federal
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(c) The ingredient is used in food under the following conditions:
Maximum Usage Levels Permitted
------------------------------------------------------------------------
Parts per
Food (as served) million Function
------------------------------------------------------------------------
Baked goods and baking mixes, 10 Flavoring agent and adjuvant,
Sec. 170.3(n)(1), of this Sec. 170.3(o)(12) of this
chapter. chapter.
Frozen dairy desserts and 10 Do.
mixes, Sec. 170.3 (n)(20)
of this chapter.
Soft candy, Sec. 10 Do.
170.3(n)(38) of this chapter.
All other food categories.... 4 Do.
------------------------------------------------------------------------
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984; 64
FR 1760, 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: 21CFR184.1702]
[Page 543-544]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1702 Sheanut oil.
(a) Sheanut oil is produced from sheanuts derived from the Shea tree
Butyrospermum parkii and is composed principally of triglycerides
containing an oleic acid moiety at the 2-position and saturated fatty
acids, usually stearic or palmitic acids, at the 1- and 3-positions.
[[Page 544]]
(b) The ingredient meets the following specifications when tested
using any appropriate validated methodology:
(1) Saponification value of 185 to 195,
(2) Iodine value of 28 to 43,
(3) Unsaponifiable matter not to exceed 1.5 percent,
(4) Free fatty acids not more than 0.1 percent as oleic acid,
(5) Peroxide value not more than 10 milliequivalents/equivalent
(meq/eq),
(6) Lead not more than 0.1 part per million (ppm),
(7) Copper not more than 0.1 ppm.
(c) In accordance with Sec. 184.1(b)(3), the ingredient is used in
the following food categories at levels not to exceed current good
manufacturing practice, except that the ingredient may not be used in a
standardized food unless permitted by the standard of identity:
Confections and frostings as defined in Sec. 170.3(n)(9) of this
chapter, coatings of soft candy as defined in Sec. 170.3(n)(38) of this
chapter, and sweet sauces and toppings as defined in Sec. 170.3(n)(43)
of this chapter.
[63 FR 28895, May 27, 1998]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1721]
[Page 544]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1721 Sodium acetate.
(a) Sodium acetate (C2H3O2Na, CAS
Reg. No. 127-09-3 or
C2H3O2Na[middot]3H2O, CAS
Reg. No. 6131-90-4) is the sodium salt of acetic acid and occurs
naturally in plant and animal tissues. Sodium acetate may occur in
either the anhydrous or trihydrated form. It is produced synthetically
by the neutralization of acetic acid with sodium carbonate or by
treating calcium acetate with sodium sulfate and sodium bicarbonate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 272, 273 which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as a flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter; and as a pH control agent
as defined in Sec. 170.3(o)(23) of this chapter.
(d) The ingredient is used in food at levels not to exceed current
good manufacturing practice in accordance with 184.1(b)(1). Current good
manufacturing practice results in a maximum level, as served, of 0.007
percent for breakfast cereals as defined in Sec. 170.3(n)(4) of this
chapter; 0.5 percent for fats and oils as defined in Sec. 170.3(n)(12)
of this chapter; 0.6 percent for grain products and pastas as defined in
Sec. 170.3(n)(23) of this chapter and snack foods as defined in
Sec. 170.3(n)(37) of this chapter; 0.15 percent for hard candy as
defined in Sec. 170.3(n)(25) of this chapter; 0.12 percent for jams and
jellies as defined in Sec. 170.3(n)(28) of this chapter and meat
products as defined in Sec. 170.3(n)(29) of this chapter; 0.2 percent
for soft candy as defined in Sec. 170.3(n)(38) of this chapter; 0.05
percent for soups and soup mixes as defined in Sec. 170.3(n)(40) of this
chapter and sweet sauces as defined in Sec. 170.3(n)(43) of this
chapter.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[47 FR 27815, June 25, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1724]
[Page 544-545]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1724 Sodium alginate.
(a) Sodium alginate (CAS Reg. No. 9005-38-3) is the sodium salt of
alginic acid, a natural polyuronide constituent of certain brown algae.
Sodium alginate is prepared by the neutralization of purified alginic
acid with appropriate pH control agents.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 274, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(2), the ingredient is used in
food only within the following specific limitations:
[[Page 545]]
------------------------------------------------------------------------
Maximum
level of
use in
Category of food food (as Functional use
served)
(percent)
------------------------------------------------------------------------
Condiments and relishes, Sec. 1.0 Texturizer, Sec.
170.3(n)(8) of this chapter, except 170.3(o)(32) of this
pimento ribbon for stuffed olives. chapter, formulation
aid Sec.
170.3(o)(14) of this
chapter, stabilizer,
thickener, Sec.
170.3(o)(28) of this
chapter.
Pimento ribbon for stuffed olives... 6.0 Do.
Confections and frostings, Sec. 0.3 Stabilizer, thickener,
170.3(n)(9) of this chapter. Sec. 170.3(o)(28) of
this chapter.
Gelatins and puddings, Sec. 4.0 Firming agent, Sec.
170.3(n)(22) of this chapter. 170.3(o)(10) of this
chapter; flavor
adjuvant, Sec.
170.3(o)(12) of this
chapter; stabilizer,
thickener, Sec.
170.3(o)(28) of this
chapter.
Hard candy, Sec. 170.3(n)(25) of 10.0 Stabilizer, thickener,
this chapter. Sec. 170.3(o)(28) of
this chapter.
Processed fruits and fruit juices, 2.0 Formulation aid, Sec.
Sec. 170.3(n)(35) of this chapter. 170.3(o)(14) of this
chapter; texturizer,
Sec. 170.3(o)(32) of
this chapter.
All other food categories........... 1.0 Emulsifier, Sec.
170.3(o)(8) of this
chapter; firming
agent, Sec.
170.3(o)(10) of this
chapter; flavor
enhancer, Sec.
170.3(o)(11) of this
chapter; flavor
adjuvant, Sec.
170.3(o)(12) of this
chapter; processing
aid, Sec.
170.3(o)(24) of this
chapter; stabilizer
and thickener, Sec.
170.3(o)(28) of this
chapter; surface
active agent, Sec.
170.3(o)(29) of this
chapter.
------------------------------------------------------------------------
(d) Prior sanctions for sodium alginate different from the uses
established in this section do not exist or have been waived.
[47 FR 29951, July 9, 1982, as amended at 48 FR 52448, Nov. 18, 1983]
[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: 21CFR184.1733]
[Page 545]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1733 Sodium benzoate.
(a) Sodium benzoate is the chemical benzoate of soda
(C7H5NaO2), produced by the
neutralization of benzoic acid with sodium bicarbonate, sodium
carbonate, or sodium hydroxide. The salt is not found to occur
naturally.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), p. 278, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as an antimicrobial agent as defined in
Sec. 170.3(o)(2) of this chapter, and as a flavoring agent and adjuvant
as defined in Sec. 170.3(o)(12) of this chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practice. Current usage results in a maximum level of 0.1
percent in food. (The Food and Drug Administration has not determined
whether significally different conditions of use would be GRAS.)
(e) Prior sanctions for this ingredient different from the uses
established in this section, or different from that set forth in part
181 of this chapter, do not exist or have been waived.
[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 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: 21CFR184.1736]
[Page 545]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1736 Sodium bicarbonate.
(a) Sodium bicarbonate (NaHCO3, CAS Reg. No. 144-55-8) is
prepared by treating a sodium carbonate or a sodium carbonate and sodium
bicarbonate solution with carbon dioxide. As carbon dioxide is absorbed,
a suspension of sodium bicarbonate forms. The slurry is filtered,
forming a cake which is washed and dried.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 278, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52442, Nov. 18, 1983]
[[Page 546]]
[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: 21CFR184.1742]
[Page 546]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1742 Sodium carbonate.
(a) Sodium carbonate (Na2CO3, CAS Reg. No.
497-19-8) is produced (1) from purified trona ore that has been calcined
to soda ash; (2) from trona ore calcined to impure soda ash and then
purified; or (3) synthesized from limestone by the Solvay process.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 280, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used in food as an antioxidant as defined in
Sec. 170.3(o)(3) of this chapter; curing and pickling agent as defined
in Sec. 170.3(o)(5) of this chapter; flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter; pH control agent as
defined in Sec. 170.3(o)(23) of this chapter; and processing aid as
defined in Sec. 170.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52442, Nov. 18, 1983, as amended at 50 FR 49536, Dec. 3, 1985]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1751]
[Page 546]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1751 Sodium citrate.
(a) Sodium citrate
(C6H5Na3O7[middot]2H2
O, CAS Reg. No. 68-0904-092) is the sodium salt of citric acid. It is
prepared by neutralizing citric acid with sodium hydroxide or sodium
carbonate. The product occurs as colorless crystals or a white
crystalline powder. It may be prepared in an anhydrous state or may
contain two moles of water per mole of sodium citrate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d ed. (1981), pp. 283-284, which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available
from the National Academy Press, 2101 Constitution Ave. NW., Washington,
DC 20418, and the Center for Food Safety and Applied Nutrition (HFS-
200), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be
examined at the Office of the Federal Register, 800 North Capitol St.
NW., suite 700, Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section, or different from those set forth in part
181 of this chapter, do not exist or have been waived.
[59 FR 63896, Dec. 12, 1994]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1754]
[Page 546-547]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1754 Sodium diacetate.
(a) Sodium diacetate
(C4H7O4Na[middot]xH2O, CAS
Reg. No. 126-96-5) is a molecular compound of acetic acid, sodium
acetate, and water of hydration. The technical grade is prepared
synthetically by reacting sodium carbonate with acetic acid. Special
grades are produced by reacting anhydrous sodium acetate and acetic
acid.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 284, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) The ingredient is used as an antimicrobial agent as defined in
Sec. 170.3(o)(2) of this chapter; flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter; and pH control agent as
defined in Sec. 170.3(o)(23) of this chapter.
(d) The ingredient is used in food at levels not to exceed current
good manufacturing practice in accordance with Sec. 184.1(b)(1). Current
good manufacturing practice results in a maximum level, as served, 0.4
percent for baked goods as defined in Sec. 170.3(n)(1) of this
[[Page 547]]
chapter; 0.1 percent for fats and oils as defined in Sec. 170.3(n)(12)
of this chapter, meat products as defined in Sec. 170.3(n)(29) of this
chapter and soft candy as defined in Sec. 170.3(n)(38) of this chapter;
0.25 percent for gravies and sauces as defined in Sec. 170.3(n)(24) of
this chapter; and 0.05 percent for snack foods as defined in
Sec. 170.3(n)(37) of this chapter and soups and soup mixes as defined in
Sec. 170.3(n)(40) of this chapter.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[47 FR 27815, June 25, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1763]
[Page 547]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1763 Sodium hydroxide.
(a) Sodium hydroxide (NaOH, CAS Reg. No. 1310-73-2) is also known as
sodium hydrate, soda lye, caustic soda, white caustic, and lye. The
empirical formula is NaOH. Sodium hydroxide is prepared commercially by
the electrolysis of sodium chloride solution and also by reacting
calcium hydroxide with sodium carbonate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), which is incorporated by reference. Copies are
available from the National Academy Press, 2101 Constitution Ave. NW.,
Washington, DC 20418, or available for inspection at the Office of the
Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a pH control agent as defined in
Sec. 170.3(o)(23) of this chapter and as a processing aid as defined in
Sec. 170.3(o)(24) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52444, Nov. 18, 1983]
[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: 21CFR184.1764]
[Page 547]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1764 Sodium hypophosphite.
(a) Sodium hypophosphite (NaH2PO2, CAS Reg.
No. 7681-53-0) is a white, odorless, deliquescent granular powder with a
saline taste. It is also prepared as colorless, pearly crystalline
plates. It is soluble in water, alcohol, and glycerol. It is prepared by
neutralization of hypophosphorous acid or by direct aqueous alkaline
hydrolysis of white phosphorus.
(b) FDA is developing food-grade specifications for sodium
hypophosphite in cooperation with the National Academy of Sciences. In
the interim, the ingredient must be of a suitable purity for its
intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitations other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as an emulsifier or stabilizer, as
defined in Secs. 170.3(o)(8) and 170.3(o)(28) of this chapter.
(2) The ingredient is used in cod-liver oil emulsions at levels not
to exceed current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the use
established in this section do not exist or have been waived.
[47 FR 38277, Aug. 31, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1768]
[Page 547-548]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1768 Sodium lactate.
(a) Sodium lactate
(C3H5O3Na, CAS Reg. No. 72-
17-3) is the sodium salt of lactic acid. It is prepared commercially by
the neutralization of lactic acid with sodium hydroxide.
(b) FDA is developing food-grade specifications for sodium lactate
in cooperation with the National Academy of Sciences. In the interim,
this ingredient must be of a purity suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good
[[Page 548]]
manufacturing practice. This regulation does not authorize its use in
infant foods and infant formulas. The affirmation of this ingredient as
generally recognized as safe (GRAS) as a direct human food ingredient is
based upon the following current good manufacturing practice conditions
of use:
(1) The ingredient is used as an emulsifier as defined in
Sec. 170.3(o)(8) of this chapter; a flavor enhancer as defined in
Sec. 170.3(o)(11) of this chapter; a flavoring agent or adjuvant as
defined in Sec. 170.3(o)(12) of this chapter; a humectant as defined in
Sec. 170.3(o)(16) of this chapter; and a pH control agent as defined in
Sec. 170.3(o)(23) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[52 FR 10886, Apr. 6, 1987]
[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: 21CFR184.1769a]
[Page 548]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1769a Sodium metasilicate.
(a) Sodium metasilicate (CAS Reg. No. 6834-92-0) is a strongly
alkaline white powder. It does not occur naturally but rather is
synthesized by melting sand with sodium carbonate at 1400 deg.C. The
commercially available forms of sodium metasilicate are the anhydrous
form (Na2SiO3), the pentahydrate
(Na2SiO3[middot]5H2O), and the
nonahydrate (Na2SiO3[middot]9H2O).
(b) FDA is developing food-grade specifications for sodium
metasilicate in cooperation with the National Academy of Sciences. In
the interim, the ingredient must be of a purity suitable for its
intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a processing aid as defined in
Sec. 170.3(o)(24) of this chapter.
(2) The ingredient is used to treat the following foods at levels
not to exceed current good manufacturing practice: for use in washing
and lye peeling of fruits, vegetables, and nuts when used in accordance
with Sec. 173.315 of this chapter; for use as a denuding agent in tripe;
for use as a hog scald agent in removing hair; and for use as a
corrosion preventative in canned and bottled water when used in
accordance with Sec. 103.35 of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 38781, Sept. 25, 1985; 50 FR 42011, Oct. 17, 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: 21CFR184.1784]
[Page 548-549]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1784 Sodium propionate.
(a) Sodium propionate (C3H5NaO2,
CAS Reg. No. 137-40-6) is the sodium salt of propionic acid. It occurs
as colorless, transparent crystals or a granular crystalline powder. It
is odorless, or has a faint acetic-butyric acid odor, and is
deliquescent. It is prepared by neutralizing propionic acid with sodium
hydroxide.
(b) The ingredients meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 296, which is incorporated by reference. Copies
are available from the the National Academy Press, 2101 Constitution
Ave. NW., Washington DC 20418, or available for inspection at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as an antimicrobial agent as defined in
Sec. 170.3(o)(2) of this chapter and a flavoring agent as defined in
Sec. 170.3(o)(12) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods as defined in
Sec. 170.3(n)(1) of this chapter; nonalcoholic beverages as defined in
Sec. 170.3(n)(3) of this chapter; cheeses as defined in Sec. 170.3(n)(5)
of this chapter; confections and frostings as defined in
Sec. 170.3(n)(9) of this chapter;
[[Page 549]]
gelatins, puddings, and fillings as defined in Sec. 170.3(n)(22) of this
chapter; jams and jellies as defined in Sec. 170.3(n)(28) of this
chapter; meat products as defined in Sec. 170.3(n)(29) of this chapter;
and soft candy as defined in Sec. 170.3(n)(38) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[49 FR 13142, Apr. 3, 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: 21CFR184.1792]
[Page 549]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1792 Sodium sesquicarbonate.
(a) Sodium sesquicarbonate
(Na2CO3[middot]NaHCO3[middot]2H2
O, CAS Reg. No. 533-96-0) is prepared by: (1) Partial carbonation of
soda ash solution followed by crystallization, centrifugation, and
drying; (2) double refining of trona ore, a naturally occurring impure
sodium sesquicarbonate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 299, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a pH control agent as defined in
Sec. 170.3(o)(23) of this chapter.
(2) The ingredient is used in cream at levels not to exceed current
good manufacturing practice. Current good manufacturing practice
utilizes a level of the ingredient sufficient to control lactic acid
prior to pasteurization and churning of cream into butter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52443, Nov. 18, 1983]
[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: 21CFR184.1801]
[Page 549]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1801 Sodium tartrate.
(a) Sodium tartrate
(C4H4Na2O6[middot]2H2
O, CAS Reg. No. 868-18-8) is the disodium salt of l-(+)-tartaric acid.
It occurs as transparent, colorless, and odorless crystals. It is
obtained as a byproduct of wine manufacture.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 303, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as an emulsifier as defined in
Sec. 170.3(o)(8) of this chapter and as a pH control agent as defined in
Sec. 170.3(o)(23) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: cheeses as defined
inSec. 170.3(n)(5) of this chapter; fats and oils as defined in
Sec. 170.3(n)(12) of this chapter; and jams and jellies as defined in
Sec. 170.3(n)(28) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52447, Nov. 18, 1983]
[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: 21CFR184.1804]
[Page 549-550]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1804 Sodium potassium tartrate.
(a) Sodium potassium tartrate
(C4H4KNaO6[middot]4H2O, CAS
Reg. No. 304-59-6) is the sodium potassium salt of l-(+)-tartaric acid
and is also called the Rochelle salt. It occurs as colorless crystals or
as a white, crystalline powder and has a cooling saline taste. It is
obtained as a byproduct of wine manufacture.
(b) The ingredient meets the specifications of the Food Chemicals
Codex,
[[Page 550]]
3d Ed. (1981), p. 296, which is incorporated by reference. Copies are
available from the National Academy Press, 2101 Constitution Ave. NW.,
Washington, DC 20418, or available for inspection at the Office of the
Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as an emulsifier as defined in
Sec. 170.3(o)(8) of this chapter and as a pH control agent as defined in
Sec. 170.3(o)(23) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: cheeses as defined in
Sec. 170.3(n)(5) of this chapter and jams and jellies as defined in
Sec. 170.3(n)(28) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 52447, Nov. 18, 1983]
[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: 21CFR184.1807]
[Page 550]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1807 Sodium thiosulfate.
(a) Sodium thiosulfate
(Na2S2O3[middot]5H2O, CAS
Reg. No. 010102-0917-097) is also known as sodium hyposulfite. It is
prepared synthetically by the reaction of sulfides and sulfur dioxide
(SO2), the reaction of sulfur and sulfite, or the oxidation
of metal sulfides and hydrosulfides.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), p. 304, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as a formulation aid as defined in
Sec. 170.3(o)(14) of this chapter and reducing agent as defined in
Sec. 170.3(o)(22) of this chapter.
(d) The ingredient is used in alcoholic beverages and table salt in
accordance with Sec. 184.1(b)(1) at levels not to exceed good
manufacturing practice. Current good manufacturing practice results in a
maximum level, as served, of 0.00005 percent for alcoholic beverages as
defined in Sec. 170.3(n)(2) of this chapter and 0.1 percent for table
salt as defined in Sec. 170.3(n)(26) of this chapter.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[43 FR 22938, May 30, 1978, as amended at 49 FR 5613, Feb. 4, 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: 21CFR184.1835]
[Page 550-551]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1835 Sorbitol.
(a) Sorbitol is the chemical 1,2,3,4,5,6-hexanehexol
(C6H14O6), a hexahydric alcohol,
differing from mannitol principally by having a different optical
rotation. Sorbitol is produced by the electrolytic reduction, or the
transition metal catalytic hydrogenation of sugar solutions containing
glucose or fructose.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), p. 308, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as an anticaking agent and free-flow
agent as defined in Sec. 170.3(o)(1) of this chapter, curing and
pickling agent as defined in Sec. 170.3(o)(5) of this chapter, drying
agent as defined in Sec. 170.3(o)(7) of this chapter, emulsifier and
emulsifier salt as defined in Sec. 170.3(o)(8) of this chapter, firming
agent as defined in Sec. 170.3(o)(10) of this chapter, flavoring agent
and adjuvant as defined in Sec. 170.3(o)(12) of this chapter,
formulation aid as defined in Sec. 170.3(o)(14) of this chapter,
humectant as defined in Sec. 170.3(o)(16) of this chapter, lubricant and
release agent as defined in Sec. 170.3(o)(18) of this chapter, nutritive
sweetener as defined in Sec. 170.3(o)(21) of this chapter, sequestrant
as defined in Sec. 170.3(o)(26) of this chapter, stabilizer and
thickener as defined in Sec. 170.3(o)(28) of this chapter, surface-
finishing agent as defined in Sec. 170.3(o)(30) of this chapter, and
texturizer as defined in Sec. 170.3(o)(32) of this chapter.
[[Page 551]]
(d) The ingredient is used in food at levels not to exceed good
manufacturing practices. Current good manufacturing practice in the use
of sorbitol results in a maximum level of 99 percent in hard candy and
cough drops as defined in Sec. 170.3(n)(25) of this chapter, 75 percent
in chewing gum as defined in Sec. 170.3(n)(6) of this chapter, 98
percent in soft candy as defined in Sec. 170.3(n)(38) of this chapter,
30 percent in nonstandardized jams and jellies, commercial, as defined
in Sec. 170.3(n)(28) of this chapter, 30 percent in baked goods and
baking mixes as defined in Sec. 170.3(n)(1) of this chapter, 17 percent
in frozen dairy desserts and mixes as defined in Sec. 170.3(n)(20) of
this chapter, and 12 percent in all other foods.
(e) The label and labeling of food whose reasonably foreseeable
consumption may result in a daily ingestion of 50 grams of sorbitol
shall bear the statement: "Excess consumption may have a laxative
effect."
(f) Prior sanctions for this ingredient different from the uses
established in this regulation do not exist or have been waived.
[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 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: 21CFR184.1845]
[Page 551]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1845 Stannous chloride (anhydrous and dihydrated).
(a) Stannous chloride is anhydrous or contains two molecules of
water of hydration. Anhydrous stannous chloride (SnCl2, CAS
Reg. No. 7772-99-8) is the chloride salt of metallic tin. It is prepared
by reacting molten tin with either chlorine or gaseous tin
tetrachloride. Dihydrated stannous chloride
(SnCl2[middot]2H2O, CAS Reg. No. 10025-0969-091)
is the chloride salt of metallic tin that contains two molecules of
water. It is prepared from granulated tin suspended in water and
hydrochloric acid or chlorine.
(b) Both forms of the ingredient meet the specifications of the Food
Chemicals Codex, 3d Ed. (1981), p. 312, which is incorporated by
reference. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or available for inspection
at the Office of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC 20408.
(c) The ingredient is used as an antioxidant as defined in
Sec. 170.3(o)(3) of this chapter.
(d) The ingredient is used in food at levels not to exceed current
good manufacturing practice in accordance with Sec. 184.(b)(1). Current
good manufacturing practice results in a maximum level, as served, of
0.0015 percent or less; calculated as tin, for all food categories.
(e) Prior sanctions for this ingredient different from those uses
established in this section do not exist or have been waived.
[47 FR 27816, June 25, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1848]
[Page 551-552]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1848 Starter distillate.
(a) Starter distillate (butter starter distillate) is a steam
distillate of the culture of any or all of the following species of
bacteria grown on a medium consisting of skim milk usually fortified
with about 0.1 percent citric acid: Streptococcus lactis, S. cremoris,
S. lactis subsp. diacetylactis, Leuconostoc citrovorum, and L.
dextranicum. The ingredient contains more than 98 percent water, and the
remainder is a mixture of butterlike flavor compounds. Diacetyl is the
major flavor component, constituting as much as 80 to 90 percent of the
mixture of organic flavor compounds. Besides diacetyl, starter
distillate contains minor amounts of acetaldehyde, ethyl formate, ethyl
acetate, acetone, ethyl alcohol, 2-butanone, acetic acid, and acetoin.
(b) FDA is developing food-grade specifications for starter
distillate in cooperation with the National Academy of Sciences. In the
interim, this ingredient must be of a purity suitable for its intended
use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
[[Page 552]]
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 51907, Nov. 15, 1983]
[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: 21CFR184.1851]
[Page 552]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1851 Stearyl citrate.
(a) Stearyl citrate is a mixture of the mono-, di-, and tristearyl
esters of citric acid. It is prepared by esterifying citric acid with
stearyl alcohol.
(b) The Food and Drug Administration, in cooperation with the
National Academy of Sciences, is developing food-grade specifications
for stearyl citrate. In the interim, this ingredient must be of a purity
suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as an antioxidant as defined in
Sec. 170.3(o)(3) of this chapter; an emulsifier and emulsifier salt as
defined in Sec. 170.3(o)(8) of this chapter; a sequestrant as defined in
Sec. 170.3(o)(26) of this chapter; and a surface-active agent as defined
in Sec. 170.3(o)(29) of this chapter.
(2) The ingredient is used in margarine in accordance with
Sec. 166.110 of this chapter; in nonalcoholic beverages as defined in
Sec. 170.3(n)(3) of this chapter; and in fats and oils as defined in
Sec. 170.3(n)(12) of this chapter at levels not to exceed current good
manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section, or different from those set forth in part
181 of this chapter, do not exist or have been waived.
[59 FR 63897, Dec. 12, 1994]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1854]
[Page 552]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1854 Sucrose.
(a) Sucrose (C12H22O11, CAS Reg.
No. 57-50-11-1) sugar, cane sugar, or beet sugar is the chemical [beta]-
D-fructofuranosyl-[alpha]-D-glucopyranoside. Sucrose is obtained by
crystallization from sugar cane or sugar beet juice that has been
extracted by pressing or diffusion, then clarified and evaporated.
(b) FDA is developing food-grade specifications for sucrose in
cooperation with the National Academy of Sciences. In the interim, this
ingredient must be of a purity suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, 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: 21CFR184.1857]
[Page 552]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1857 Corn sugar.
(a) Corn sugar (C6H12O6, CAS Reg.
No. 50-99-7), commonly called D-glucose or dextrose, is the chemical
[alpha]-D-glucopyranose. It occurs as the anhydrous or the monohydrate
form and is produced by the complete hydrolysis of corn starch with safe
and suitable acids or enzymes, followed by refinement and
crystallization from the resulting hydrolysate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 97-98 under the heading "Dextrose," which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 1. Copies are available from the National Academy Press, 2101
Constitution Ave., NW., Washington, DC 20418, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[53 FR 44876, Nov. 7, 1988]
[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: 21CFR184.1859]
[Page 552-553]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1859 Invert sugar.
(a) Invert sugar (CAS Reg. No. 8013-17-0) is an aqueous solution of
inverted or partly inverted, refined or partly refined sucrose, the
solids of which contain not more than 0.3 percent by
[[Page 553]]
weight of ash. The solution is colorless, odorless, and flavorless,
except for sweetness. It is produced by the hydrolysis or partial
hydrolysis of sucrose with safe and suitable acids or enzymes.
(b) FDA is developing food-grade specifications for invert sugar in
cooperation with the National Academy of Sciences. In the interim, this
ingredient must be of a purity suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, 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: 21CFR184.1865]
[Page 553]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1865 Corn syrup.
(a) Corn syrup, commonly called "glucose sirup" or "glucose
syrup," is obtained by partial hydrolysis of corn starch with safe and
suitable acids or enzymes. It may also occur in the dehydrated form
(dried glucose sirup). Depending on the degree of hydrolysis, corn syrup
may contain, in addition to glucose, maltose and higher saccharides.
(b) The ingredient meets the specifications as defined and
determined in Sec. 168.120(b) or Sec. 168.121(a) of this chapter, as
appropriate. FDA, in cooperation with the National Academy of Sciences,
is undertaking a study to determine if additional food-grade
specifications for corn syrup are necessary.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[53 FR 44876, Nov. 7, 1988]
[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: 21CFR184.1866]
[Page 553]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1866 High fructose corn syrup.
(a) High fructose corn syrup, a sweet, nutritive saccharide mixture
containing either approximately 42 or 55 percent fructose, is prepared
as a clear aqueous solution from high dextrose-equivalent corn starch
hydrolysate by partial enzymatic conversion of glucose (dextrose) to
fructose using an insoluble glucose isomerase enzyme preparation
described in Sec. 184.1372. The product containing more than 50 percent
fructose (dry weight) is prepared through concentration of the fructose
portion of the mixture containing less than 50 percent fructose.
(b) The ingredient shall conform to the identity and specifications
listed in the monograph entitled "High-Fructose Corn Syrup" in the
Food Chemicals Codex, 4th ed. (1996), pp. 191-192, which is incorporated
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
Copies are available from the Office of Premarket Approval, Center for
Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may
be examined at the Center for Food Safety and Applied Nutrition's
Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the
Office of the Federal Register, 800 North Capitol St. NW., suite 700,
Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
[61 FR 43450, Aug.23, 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: 21CFR184.1875]
[Page 553-554]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1875 Thiamine hydrochloride.
(a) Thiamine hydrochloride
(C12H17C1N4OS[middot]HCl, CAS Reg. No.
67-03-8) is the chloride-hydrochloride salt of thiamine. It occurs as
hygroscopic white crystals or a white crystalline powder. The usual
method of preparing this substance is by linking the preformed thiazole
and pyrimidine ring systems.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 324, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good
[[Page 554]]
manufacturing practice. The affirmation of this ingredient as generally
recognized as safe (GRAS) as a direct human food ingredient is based
upon the following current good manufacturing practice conditions of
use:
(1) The ingredient is used as a flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter or as a nutrient supplement
as defined in Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Thiamine hydrochloride may be used in
infant formula in accordance with section 412(g) of the Federal Food,
Drug, and Cosmetic Act (the Act) or with regulations promulgated under
section 412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 55124, Dec. 9, 1983]
[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: 21CFR184.1878]
[Page 554]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1878 Thiamine mononitrate.
(a) Thiamine mononitrate
(C12H17N5O4S, CAS Reg. No.
532-43-4) is the mononitrate salt of thiamine. It occurs as white
crystals or a white crystalline powder and is prepared from thiamine
hydrochloride by dissolving the hydrochloride salt in alkaline solution
followed by precipitation of the nitrate half-salt with a stoichiometric
amount of nitric acid.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 325, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Thiamine mononitrate may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the Act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 55124, Dec. 9, 1983]
[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: 21CFR184.1890]
[Page 554]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1890 [alpha]-Tocopherols.
(a) The [alpha]-tocopherols that are the subject of this GRAS
affirmation regulation are limited to the following:
(1) d-[alpha]-Tocopherol (CAS Reg. No. 59-02-9) is the chemical
[2R,4'R,8prime;R]-2,5,7,8-tetramethyl-2-(4',8',12'-trimethyl-tridecyl)-
6-chromanol. It occurs commercially as a concentrate and is a red,
nearly odorless, viscous oil. It is obtained by vacuum steam
distillation of edible vegetable oil products.
(2) dl-[alpha]-Tocopherol (CAS Reg. No. 10191-41-0) is a mixture of
stereoisomers of 2,5,7,8-tetramethyl-2-(4',8',12'-trimethyl-tridecyl)-6-
chromanol. It is chemically synthesized by condensing racemic isophytol
with trimethyl hydroquinone. It is a pale yellow viscous oil at room
temperature.
(b) The ingredients meet the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 330-331, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(3), the affirmation of the
ingredients as generally recognized as safe is limited to the following
conditions of use while the agency concludes the general evaluation of
all food uses of tocopherols:
(1) The ingredients are used as inhibitors of nitrosamine formation.
(2) The ingredients are used in pump-cured bacon at levels not to
exceed current good manufacturing practice.
[49 FR 13348, Apr. 4, 1984]
[[Page 555]]
[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: 21CFR184.1901]
[Page 555]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1901 Triacetin.
(a) Triacetin (C8 H14O6, CAS Reg.
No. 102-76-1), also known as 1,2,3,-propanetriol triacetate or glyceryl
triacetate, is the triester of glycerin and acetic acid. Triacetin can
be prepared by heating glycerin with acetic anhydride alone or in the
presence of finely divided potassium hydrogen sulfate. It can also be
prepared by the reaction of oxygen with a liquid-phase mixture of allyl
acetate and acetic acid using a bromide salt as a catalyst.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 337-338, as revised by the First Supplement to
the 3d Ed., which is incorporated by reference in accordance with 5
U.S.C. 552(a). Copies are available from the National Academy Press,
2102 Constitution Ave., NW., Washington, DC 20418, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20005.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used in food as a flavoring agent and adjuvant
as defined in Sec. 170.3(o)(12) of this chapter; a formulation aid as
defined in Sec. 170.3(o)(14) of this chapter; and humectant as defined
in Sec. 170.3(o)(16) of this chapter; and a solvent and vehicle as
defined in Sec. 170.3(o)(27) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods and baking mixes
as defined in Sec. 170.3(n)(1) of this chapter, alcoholic beverages as
defined in Sec. 170.3(n)(2) of this chapter; nonalcoholic beverages and
beverage bases as defined in Sec. 170.3(n)(3) of this chapter; chewing
gum as defined in Sec. 170.3(n)(6) of this chapter; confections and
frostings as defined in Sec. 170.3(n)(9) of this chapter; frozen dairy
dessert and mixes as defined in Sec. 170.3(n)(20) of this chapter;
gelatins, puddings, and fillngs as defined in Sec. 170.3(n)(22) of this
chapter; hard candy as defined in Sec. 170.3(n)(25) of this chapter; and
soft candy as defined in Sec. 170.3(n)(38) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[54 FR 7404, Feb. 21, 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: 21CFR184.1903]
[Page 555-556]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1903 Tributyrin.
(a) Tributyrin (C15H26O6, CAS Reg.
No. 60-01-5), also known as butyrin or glyceryl tributyrate, is the
triester of glycerin and butyric acid. It is prepared by esterification
of glycerin with excess butyric acid.
(b) The ingredient meets the specification of the Food Chemicals
Codex, 3d Ed. (1981), p. 416, which is incorporated by reference in
accordance with 5 U.S.C. 552(a). Copies are available from the National
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20005.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generaly recognized as safe (GRAS)
as a direct human food ingredient is based upon the following current
good manufacturing practice conditions of use:
(1) The ingredient is used in food as a flavoring agent and adjuvant
as defined in Sec. 170.3(o)(12) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice; baked goods as defined in
Sec. 170.3(n)(1) of this chapter; alcoholic beverages as defined in
Sec. 170.3(n)(2) of this chapter; nonalcoholic beverages as defined in
Sec. 170.3(n)(3) of this chapter; fats and oils as defined in
Sec. 170.3(n)(12) of this chapter; frozen dairy desserts and mixes as
defined in Sec. 170.3(n)(20) of this chapter; gelatins, puddings and
fillngs as defined in Sec. 170.3(n)(22) of this chapter; and soft candy
as defined in Sec. 170.3(n)(38) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in
[[Page 556]]
this section do not exist or have been waived.
[54 FR 7404, Feb. 21, 1989; 54 FR 10482, Mar. 13, 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: 21CFR184.1911]
[Page 556]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1911 Triethyl citrate.
(a) Triethyl citrate (C12H20O7, CAS
Reg. No. 77-93-0) is the triethyl ester of citric acid. It is prepared
by esterifying citric acid with ethyl alcohol and occurs as an odorless,
practically colorless, oily liquid.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d ed. (1981), p. 339, which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available
from the National Academy Press, 2101 Constitution Ave. NW., Washington,
DC 20418, and the Center for Food Safety and Applied Nutrition (HFS-
200), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be
examined at the Office of the Federal Register, 800 North Capitol St.
NW., suite 700, Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent as defined in
Sec. 170.3(o)(12) of this chapter; a solvent and vehicle as defined in
Sec. 170.3(o)(27) of this chapter; and a surface-active agent as defined
in Sec. 170.3(o)(29) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section, or different from those set forth in part
181 of this chapter, do not exist or have been waived.
[59 FR 63897, Dec. 12, 1994]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1914]
[Page 556]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1914 Trypsin.
(a) Trypsin (CAS Reg. No. 9002-07-7) is an enzyme preparation
obtained from purified extracts of porcine or bovine pancreas. It is a
white to tan amorphous powder. Its characterizing enzyme activity is
that of a peptide hydrolase (EC 3.4.21.4).
(b) The ingredient meets the general requirements and additional
requirements for enzyme preparations in the Food Chemicals Codex, 3d ed.
(1981), p. 110, which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may
be examined at the Office of Premarket Approval (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and the
Office of the Federal Register, 800 North Capitol St. NW., suite 700,
Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as GRAS as a direct food ingredient
is based upon the following current good manufacturing practice
conditions of use:
(1) The ingredient is used as an enzyme as defined in
Sec. 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
[60 FR 32911, June 26, 1995]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1923]
[Page 556-557]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1923 Urea.
(a) Urea (CO(NH2)2, CAS Reg. No. 57-13-6) is
the diamide of carbonic acid and is also known as carbamide. It is a
white, odorless solid and is commonly produced from CO2 by
ammonolysis or from cyanamide by hydrolysis.
(b) FDA is developing food-grade specifications for urea in
cooperation with the National Academy of Sciences. In the interim, this
ingredient must be of a purity suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe as a
direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
[[Page 557]]
(1) The ingredient is used as a formulation aid as defined in
Sec. 170.3(o)(14) of this chapter and as a fermentation aid.
(2) The ingredient is used in yeast-raised bakery products; in
alcoholic beverages as defined in Sec. 170.3(n)(2) of this chapter; and
in gelatin products.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 51616, Nov. 10, 1983, as amended at 49 FR 19816, May 10, 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: 21CFR184.1924]
[Page 557]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1924 Urease enzyme preparation from Lactobacillus fermentum.
(a) This enzyme preparation is derived from the nonpathogenic,
nontoxicogenic bacterium Lactobacillus fermentum. It contains the enzyme
urease (CAS Reg. No. 9002-13-5), which facilitates the hydrolysis of
urea to ammonia and carbon dioxide. It is produced by a pure culture
fermentation process and by using materials that are generally
recognized as safe (GRAS) or are food additives that have been approved
for this use by the Food and Drug Administration (FDA).
(b) The ingredient meets the general and additional requirements for
enzyme preparations in the "Food Chemicals Codex," 3d ed. (1981), pp.
107-110, which is incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies are available from the National Academy
Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available
for inspection at the Office of the Federal Register, 800 North Capitol
St. NW., suite 700, Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as GRAS as a direct human food
ingredient is based upon the following current good manufacturing
practice conditions of use:
(1) The ingredient is used in wine, as defined in 27 CFR 2.5 and
4.10, as an enzyme as defined in Sec. 170.3(o)(9) of this chapter to
convert urea to ammonia and carbon dioxide.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Current good manufacturing practice is
limited to use of this ingredient in wine to inhibit formation of ethyl
carbamate.
[57 FR 60473, Dec. 21, 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: 21CFR184.1930]
[Page 557-558]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1930 Vitamin A.
(a)(1) Vitamin A (retinol; CAS Reg. No. 68-26-8) is the alcohol
9,13-dimethyl-7-(1,1,5-trimethyl-6-cyclohexen-5-yl)-7,9,11,13-
nonatetraen-15-ol. It may be nearly odorless or have a mild fishy odor.
Vitamin A is extracted from fish liver oils or produced by total
synthesis from [beta]-ionone and a propargyl halide.
(2) Vitamin A acetate (retinyl acetate; CAS Reg. No. 127-47-9) is
the acetate ester of retinol. It is prepared by esterifying retinol with
acetic acid.
(3) Vitamin A palmitate (retinyl palmitate; CAS Reg. No. 79-81-2) is
the palmitate ester of retinol. It is prepared by esterifying retinol
with palmitic acid.
(b) The ingredient meets the specifications for vitamin A in the
Food Chemicals Codex, 3d Ed. (1981), p. 342, which is incorporated by
reference. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or available for inspection
at the Office of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used in food as a nutrient supplement as
defined in Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice. Vitamin A may be used in infant formula in
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic
Act (the act) or with regulations promulgated under section 412(a)(2) of
the Act.
(d) Prior sanctions for this ingredient different from the uses
established in
[[Page 558]]
this section do not exist or have been waived.
[48 FR 51610, Nov. 10, 1983]
[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: 21CFR184.1945]
[Page 558]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1945 Vitamin B12.
(a) Vitamin B12, also known as cyanocobalamin
(C63H88CoN14O14P, CAS Reg.
No. 68-0919-099), is produced commercially from cultures of Streptomyces
griseus.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 343, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Vitamin B12 also may be used in
infant formula in accordance with section 412(g) of the Federal Food,
Drug, and Cosmetic Act (the act) or with regulations promulgated under
section 412(a)(2) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 6341, Feb. 15, 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: 21CFR184.1950]
[Page 558-559]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1950 Vitamin D.
(a) Vitamin D is added to food as the following food ingredients:
(1) Crystalline vitamin D2
(C28H44O, CAS Reg. No. 50-14-6), also known as
ergocalciferol, is the chemical 9,10-seco(5Z,7E,22E)-5,7,10(19),22-
ergostatetraen-3-ol. The ingredient is produced by ultraviolet
irradiation of ergosterol isolated from yeast and related fungi and is
purified by crystallization.
(2) Crystalline vitamin D3
(C27H44O, CAS Reg. No. 67-97-0), 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 is also manufactured by ultraviolet
irradiation of 7-dehydrocholesterol produced from cholesterol. It is
purified by crystallization. Vitamin D3 is the vitamin D form
that is produced endogenously in humans through sunlight activation of
7-dehydrocholesterol in the skin.
(3) Vitamin D2 resin and vitamin D3 resin are
the concentrated forms of irradiated ergosterol (D2) and
irradiated 7-dehydrocholesterol (D3) that are separated from
the reacting materials in paragraphs (a) (1) and (2) of this section.
The resulting products are sold as food sources of vitamin D without
further purification.
(b) Vitamin D2 and vitamin D3 as crystals meet
the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 344
and 345, which is incorporated by reference. Copies are available from
the National Academy Press, 2101 Constitution Ave. NW., Washington, DC
20418, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408. FDA is developing food-grade specifications for vitamin
D2 resin and vitamin D3 resin in cooperation with
the National Academy of Sciences. In the interim, these resins must be
of a purity suitable for their intended use.
(c)(1) In accordance with Sec. 184.1(b)(2), the ingredients are used
in food as the sole source of added vitamin D only within the following
specific limitations:
------------------------------------------------------------------------
Maximum levels in
Category of food food (as served) Functional use
------------------------------------------------------------------------
Breakfast cereals, Sec. 350 (IU/100 grams) Nutrient
170.3(n)(4) of this chapter. supplement, Sec.
170.3(o)(20) of
this chapter.
Grain products and pastas, Sec. 90(IU/100 grams).. Do.
170.3(n)(23) of this chapter.
Milk, Sec. 170.3(n)(30) of this 42 (IU/100 grams). Do.
chapter.
Milk products, Sec. 89 (IU/100 grams). Do.
170.3(n)(31) of this chapter.
------------------------------------------------------------------------
[[Page 559]]
(2) Vitamin D may be used in infant formula in accordance with
section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or
with regulations promulgated under section 412(a)(2) of the act.
(3) Vitamin D may be used in margarine in accordance with
Sec. 166.110 of this chapter.
(d) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
[50 FR 30152, July 24, 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: 21CFR184.1973]
[Page 559]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1973 Beeswax (yellow and white).
(a) Beeswax (CAS Reg. No. 8012-89-3) is a secretory product of honey
bees used as a structural material in honeycombs. Beeswax is prepared
from honeycombs after removal of the honey by draining or centrifuging.
The combs are melted in hot water or steam or with solar heat, and
strained. The wax is refined by melting in hot water to which sulfuric
acid or alkali may be added to extract impurities. The resulting wax is
referred to as yellow beeswax. White beeswax is produced by bleaching
the constituent pigments of yellow beeswax with peroxides, or preferably
it is bleached by sun light.
(b) The ingredient meets the specifications of the "Food Chemicals
Codex," 3d Ed. (1981), pp. 34-35, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as a flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter, as a lubricant as defined
in Sec. 170.3(o)(18) of this chapter, and as a surface-finishing agent
as defined in Sec. 170.3(o)(30) of this chapter.
(d) The ingredient is used in food, in accordance with
Sec. 184.1(b)(1) of this chapter, at levels not to exceed good
manufacturing practice. Current good manufacturing practice results in a
maximum level, as served, of: 0.065 percent for chewing gum as defined
in Sec. 170.3(n)(6) of this chapter; 0.005 percent for confections and
frostings as defined in Sec. 170.3(n)(9) of this chapter; 0.04 percent
for hard candy as defined in Sec. 170.3(n)(25) of this chapter; 0.1
percent for soft candy as defined in Sec. 170.3(n)(38) of this chapter;
and 0.002 percent or less for all other food categories.
[43 FR 14644, Apr. 7, 1978, as amended at 49 FR 5613, Feb. 14, 1984; 50
FR 49536, Dec. 3, 1985]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1976]
[Page 559]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1976 Candelilla wax.
(a) Candelilla wax (CAS Reg. No. 8006-44-8) is obtained from the
candelilla plant. It is a hard, yellowish-brown, opaque-to-translucent
wax. Candelilla wax is prepared by immersing the plants in boiling water
containing sulfuric acid and skimming off the wax that rises to the
surface. It is composed of about 50 percent hydrocarbons with smaller
amounts of esters and free acids.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 67, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a lubricant as defined in
Sec. 170.3(o)(18) of this chapter and as a surface-finishing agent as
defined in Sec. 170.3(o)(30) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: in chewing gum as defined in
Sec. 170.3(n)(6) of this chapter and in hard candy as defined in
Sec. 170.3(n)(25) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 51617, Nov. 10, 1983]
[[Page 560]]
[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: 21CFR184.1978]
[Page 560]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1978 Carnauba wax.
(a) Carnauba wax (CAS Reg. No. 008-015-869) is obtained from the
leaves and buds of the Brazilian wax palm Copernicia cerifera Martius.
The wax is hard, brittle, sparingly soluble in cold organic solvents and
insoluble in water. It is marketed in five grades designated No. 1
through No. 5. Grades No. 4 and No. 5 represent the bulk of the
commercial trade volume. These commercial grades consist chiefly of
C24 to C32 normal saturated monofunctional fatty
acids and normal saturated monofunctional primary alcohols.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 73, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as an anticaking agent as defined
Sec. 170.3(o)(1) of this chapter; as a formulation aid as defined in
Sec. 170.3(o)(14) of this chapter; as a lubricant and release agent as
defined in Sec. 170.3(o)(18) of this chapter; and as a surface-finishing
agent as defined in Sec. 170.3(o)(30) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods and baking mixes
as defined in Sec. 170.3(n)(1) of this chapter; chewing gun as defined
in Sec. 170.3(n)(6) of this chapter; confections and frostings as
defined in Sec. 170.3(n)(9) of this chapter; fresh fruits and fruit
juices as defined in Sec. 170.3(n)(16) of this chapter; gravies and
sauces as defined in Sec. 170.3(n)(24) of this chapter; processed fruits
and fruit juices as defined in Sec. 170.3(n)(35) of this chapter; and
soft candy as defined in Sec. 170.3(n)(38) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 51147, Nov. 7, 1983]
[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: 21CFR184.1979]
[Page 560-561]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1979 Whey.
(a)(1) Whey. Whey is the liquid substance obtained by separating the
coagulum from milk, cream, or skim milk in cheesemaking. Whey obtained
from a procedure, in which a significant amount of lactose is converted
to lactic acid, or from the curd formation by direct acidification of
milk, is known as acid whey. Whey obtained from a procedure in which
there is insignificant conversion of lactose to lactic acid is known as
sweet whey. Sweet whey has a maximum titratable acidity of not more than
0.16 percent, calculated as lactic acid, and an alkalinity of ash of not
more than 225 milliliters of 0.1N hydrochloric acid per 100 grams. The
acidity of whey, sweet or acid, may be adjusted by the addition of safe
and suitable pH-adjusting ingredients.
(2) Concentrated whey. Concentrated whey is the liquid substance
obtained by the partial removal of water from whey, while leaving all
other constituents in the same relative proportions as in whey.
(3) Dry or dried whey. Dry or dried whey is the dry substance
obtained by the removal of water from whey, while leaving all other
constituents in the same relative proportions as in whey.
(b) The ingredients meet the following specifications:
(1) The analysis of whey, concentrated whey, and dry (dried) whey,
on a dry product basis, based on analytical methods in the referenced
sections of "Official Methods of Analysis of the Association of
Official Analytical Chemists," 13th ed. (1980), which is incorporated
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, is
given in paragraphs (b)(1)(i) through (b)(1)(vii) of this section.
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 Center
[[Page 561]]
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.
(i) Protein content, 10 to 15 percent--as determined by the methods
prescribed in section 16.036 (liquid sample), entitled "Total Nitrogen-
-Official Final Action" under the heading "Total Solids," or in
section 16.193 (dry sample), entitled "Kjeldahl Method" under the
heading "Protein--Official Final Action."
(ii) Fat content, 0.2 to 2.0 percent--as determined by the methods
prescribed in section 16.059 (liquid sample), "Reese-Gottlieb Method
[Reference Method] (11)--Official Final Action" under the heading
"Fat," or in section 16.199 (dry sample), entitled "Fat in Dried Milk
(45)--Official Final Action."
(iii) Ash content, 7 to 14 percent--as determined by the methods
prescribed in section 16.035 (liquid sample), entitled "Ash (5)--
Official Final Action" under the heading "Total Solids," or in
section 16.196 (dry sample), entitled "Ash--Official Final Action"
under the heading "Dried Milk, Nonfat Dry Milk, and Malted Milk."
(iv) Lactose content, 61 to 75 percent--as determined by the methods
prescribed in section 16.057 (liquid sample), entitled "Gravimetric
Method--Official Final Action" under the heading "Lactose," or in
section 31.061 (dry sample), entitled "Lane-Eynon General Volumetric
Method" under the heading "Lactose--Chemical Methods--Official Final
Action."
(v) Moisture content, 1 to 8 percent--as determined by the methods
prescribed in section 16.192, entitled "Moisture (41)--Official Final
Action" under the heading "Dried Milk, Nonfat Dry Milk, and Malted
Milk."
(vi) Solids content, variable--as determined by the methods
prescribed in section 16.032, entitled "Method I--Official Final
Action" under the heading "Total Solids."
(vii) Titratable Acidity, variable--as determined by the methods
prescribed in section 16.023, entitled "Acidity (2)--Official Final
Action" under the heading "Milk," or by an equivalent potentiometric
method.
(2) Limits of impurities are: Heavy metals (as lead). Not more than
10 parts per million (0.001 percent) as determined by the method
described in the "Food Chemicals Codex," 4th ed. (1996), pp. 760-761,
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.
(3) The whey must be derived from milk that has been pasteurized, or
the whey and modified whey product must be subjected to pasteurization
techniques or its equivalent before use in food.
(c) Whey, concentrated whey, and dry (dried) whey may be used in
food in accordance with good manufacturing practice as indicated in
Sec. 184.1(b)(1).
(d) The label on the whey form sold to food manufacturers shall read
as follows:
(1) For whey: "(Sweet or acid) whey" or "whey (----% titratable
acidity).
(2) For concentrated whey: "Concentrated (sweet or acid) whey, ----
% solids" or "Concentrated whey (----% titratable acidity), ----%
solids".
(3) For dry (dried) whey: "Dry (dried) (sweet or acid) whey" or
"dry (dried) whey, (----% titratable acidity)".
(e) Whey, concentrated whey, or dry (dried) whey in a finished food
product shall be listed as "whey."
[46 FR 44439, Sept. 4, 1981; 47 FR 7410, Feb. 19, 1982, as amended at 54
FR 24899, June 12, 1989; 64 FR 1760, 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: 21CFR184.1979a]
[Page 561-563]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1979a Reduced lactose whey.
(a) Reduced lactose whey is the substance obtained by the removal of
lactose from whey. The lactose content of the finished dry product shall
not exceed 60 percent. Removal of the lactose is accomplished by
physical separation techniques such as precipitation, filtration, or
dialysis. As with whey, reduced lactose whey can be used as a fluid,
concentrate, or a dry product form.
[[Page 562]]
The acidity of reduced lactose whey may be adjusted by the addition of
safe and suitable pH-adjusting ingredients.
(b) The reduced lactose whey meets the following specifications:
(1) The analysis of reduced lactose whey, on a dry product basis,
based on analytical methods in the referenced sections of "Official
Methods of Analysis of the Association of Official Analytical
Chemists," 13th ed. (1980), which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, is given in
paragraphs (b)(1)(i) through (b)(1)(vii) of this section. 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 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.
(i) Protein content, 16 to 24 percent--as determined by the methods
prescribed in section 16.036 (liquid sample), entitled "Total Nitrogen-
-Official Final Action" under the heading "Total Solids," or in
section 16.193 (dry sample), entitled "Kjeldahl Method" under the
heading "Protein--Official Final Action."
(ii) Fat content, 1 to 4 percent--as determined by the methods
prescribed in section 16.059 (liquid sample), "Reese-Gottlieb Method
[Reference Method] (11)--Official Final Action" under the heading
"Fat," or in section 16.199 (dry sample), entitled "Fat in Dried Milk
(45)--Official Final Action."
(iii) Ash content, 11 to 27 percent--as determined by the methods
prescribed in section 16.035 (liquid sample), entitled "Ash (5)--
Official Final Action" under the heading "Total Solids," or in
section 16.196 (dry sample), entitled "Ash--Official Final Action"
under the heading "Dried Milk, Nonfat Dry Milk, and Malted Milk."
(iv) Lactose content, not more than 60 percent--as determined by the
methods prescribed in section 16.057 (liquid sample), entitled
"Gravimetric Method--Official Final Action" under the heading
"Lactose," or in section 31.061 (dry sample), entitled "Lane-Eynon
General Volumetric Method" under the heading "Lactose--Chemical
Methods--Official Final Action."
(v) Moisture content, 1 to 6 percent--as determined by the method
prescribed in section 16.192, entitled "Moisture (41)--Official Final
Action" under the heading "Dried Milk, Nonfat Dry Milk, and Malted
Milk."
(vi) Solids content, variable--as determined by the methods
prescribed in section 16.032, entitled "Method I--Official Final
Action" under the heading "Total Solids."
(vii) Titratable Acidity, variable--as determined by the methods
prescribed in section 16.023, entitled "Acidity (2)--Official Final
Action" under the heading "Milk," or by an equivalent potentiometric
method.
(2) Limits of impurities are: Heavy metals (as lead). Not more than
10 parts per million (0.001 percent), as determined by the method
described in the "Food Chemicals Codex," 4th ed. (1996), pp. 760-761,
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.
(3) The reduced lactose whey shall be derived from milk that has
been pasteurized, or the reduced lactose whey shall be subjected to
pasteurization techniques or its equivalent before use in food.
(c) Reduced lactose whey may be used in food in accordance with good
manufacturing practice as indicated in Sec. 184.1(b)(1).
(d) The percent of lactose present on a dry product basis, i.e.,
"reduced lactose whey (----% lactose)," shall be declared on the label
of the package sold to food manufacturers. The percent of lactose may be
declared in 5-percent increments, expressed as a multiple of 5, not
greater than the actual percentage of lactose in the product, or as a
actual percentage provided that an
[[Page 563]]
analysis of the product on which the actual percentage is based is
supplied to the food manufacturer.
(e) The presence of reduced lactose whey in a finished food product
shall be listed as "reduced lactose whey."
[46 FR 44440, Sept. 4, 1981, as amended at 54 FR 24899, June 12, 1989;
64 FR 1760, 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: 21CFR184.1979b]
[Page 563-564]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1979b Reduced minerals whey.
(a) Reduced minerals whey is the substance obtained by the removal
of a portion of the minerals from whey. The dry product shall not
contain more than 7 percent ash. Reduced minerals whey is produced by
physical separation techniques such as precipitation, filtration, or
dialysis. As with whey, reduced minerals whey can be used as a fluid,
concentrate, or a dry product form. The acidity of reduced minerals whey
may be adjusted by the additional of safe and suitable pH-adjusting
ingredients.
(b) The reduced minerals whey meets the following specifications:
(1) The analysis of reduced minerals whey, on a dry product basis,
based on analytical methods in the referenced sections of "Official
Methods of Analysis of the Association of Official Analytical
Chemists," 13th ed. (1980), which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, is given in
paragraphs (b)(1)(i) through (b)(1)(vii) of this section. 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 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.
(i) Protein content, 10 to 24 percent--as determined by the methods
prescribed in section 16.036 (liquid sample), entitled "Total Nitrogen-
-Official Final Action" under the heading "Total Solids," or in
section 16.193 (dry sample), entitled "Kjeldahl Method" under the
heading "Protein--Official Final Action."
(ii) Fat content, 1 to 4 percent--as determined by the methods
prescribed in section 16.059 (liquid sample), "Reese-Gottlieb Method
[Reference Method] (11)--Official Final Action" under the heading
"Fat," or in section 16.199 (dry sample), entitled "Fat in Dried Milk
(45)--Official Final Action."
(iii) Ash content, maximum 7 percent--as determined by the methods
prescribed in section 16.035 (liquid sample), entitled "Ash (5)--
Official Final Action" under the heading "Total Solids," or in
section 16.196 (dry sample), entitled "Ash--Official Final Action"
under the heading "Dried Milk, Nonfat Dry Milk, and Malted Milk."
(iv) Lactose content, maximum 85 percent--as determined by the
methods prescribed in section 16.057 (liquid sample), entitled
"Gravimetric Method--Official Final Action" under the heading
"Lactose," or in section 31.061 (dry sample), entitled "Lane-Eynon
General Volumetric Method" under the heading "Lactose--Chemical
Methods--Official Final Action."
(v) Moisture content, 1 to 6 percent--as determined by the methods
prescribed in section 16.192, entitled "Moisture (41)--Official Final
Action" under the heading "Dried Milk, Nonfat Dry Milk, and Malted
Milk."
(vi) Solids content, variable--as determined by the methods
prescribed in section 16.032, entitled "Method I--Official Final
Action" under the heading "Total Solid."
(vii) Titratable Acidity, variable--as determined by the methods
prescribed in section 16.023, entitled "Acidity (2)--Official Final
Action" under the heading "Milk," or by an equivalent potentiometric
method.
(2) Limits of impurities are: Heavy metals (as lead). Not more than
10 parts per million (0.001 percent), as determined by the method
described in the "Food Chemicals Codex," 4th ed. (1996), pp. 760-761,
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
[[Page 564]]
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(3) The reduced minerals whey shall be derived from milk that has
been pasteurized, or the reduced minerals whey shall be subjected to
pasteurization techniques or its equivalent before use in food.
(c) The reduced minerals whey may be used in food in accordance with
good manufacturing practice as indicated in Sec. 184.1(b)(1).
(d) The percent of minerals present on a dry product basis, i.e.,
"reduced minerals whey (----% minerals)," shall be declared on the
label of the package sold to food manufacturers. The percent of minerals
may be declared in 2-percent increments expressed as a multiple of 2,
not greater than the actual percentage of minerals in the product, or as
an actual percentage provided that an analysis of the product on which
the actual percentage is based is supplied to the food manufacturer.
(e) The presence of reduced minerals whey in a finished food product
shall be listed as "reduced minerals whey".
[46 FR 44441, Sept. 4, 1981, as amended at 54 FR 24899, June 12, 1989;
64 FR 1761, 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: 21CFR184.1979c]
[Page 564-565]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1979c Whey protein concentrate.
(a) Whey protein concentrate is the substance obtained by the
removal of sufficient nonprotein constituents from whey so that the
finished dry product contains not less than 25 percent protein. Whey
protein concentrate is produced by physical separation techniques such
as precipitation, filtration, or dialysis. As with whey, whey protein
concentrate can be used as a fluid, concentrate, or dry product form.
The acidity of whey protein concentrate may be adjusted by the addition
of safe and suitable pH-adjusting ingredients.
(b) The whey protein concentrate meets the following specifications:
(1) The analysis of whey protein concentrate, on a dry product
basis, based on analytical methods in the referenced sections of
"Official Methods of Analysis of the Association of Official Analytical
Chemists," 13th ed. (1980), which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, is given in
paragraphs (b)(1)(i) through (b)(1)(vii) of this section. 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 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.
(i) Protein content, minimum 25 percent--as determined by the
methods prescribed in section 16.036 (liquid sample), entitled "Total
Nitrogen--Officials Final Action" under the heading "Total Solids,"
or in section 16.193 (dry sample), entitled "Kjeldahl Method" under
the heading "Protein--Official Final Action."
(ii) Fat content, 1 to 10 percent--as determined by the methods
prescribed in section 16.059 (liquid sample), "Reese-Gottlieb Method
[Reference Method] (11)--Official Final Action" under the heading
"Fat," or in section 16.199 (dry sample), entitled "Fat in Dried Milk
(45)--Official Final Action."
(iii) Ash content, 2 to 15 percent--as determined by the methods
prescribed in section 16.035 (liquid sample), entitled "Ash (5)--
Official Final Action" under the heading "Total Solids," or in
section 16.196 (dry sample), entitled "Ash--Official Final Action"
under the heading "Dried Milk, Nonfat Dry Milk, and Malted Milk."
(iv) Lactose content, maximum 60 percent--as determined by the
methods prescribed in section 16.057 (liquid sample), entitled
"Gravimetric Method--Official Final Action" under the heading
"Lactose," or in section 31.061 (dry sample), entitled "Lane-Eynon
General Volumetric Method" under the heading "Lactose--Chemical
Methods--Official Final Action."
(v) Moisture content, 1 to 6 percent--as determined by the methods
prescribed in section 16.192, entitled "Moisture (41)--Official Final
Action" under the heading "Dried Milk, Nonfat Dry Milk, and Malted
Milk."
(vi) Solids content, variable--as determined by the methods
prescribed in section 16.032, entitled "Method I--Official Final
Action" under the heading "Total Solids."
[[Page 565]]
(vii) Titratable Acidity, variable--as determined by the methods
prescribed in section 16.023, entitled "Acidity (2)--Official Final
Action" under the heading "Milk," or by an equivalent potentiometric
method.
(2) Limits of impurities are: Heavy metals (as lead). Not more than
10 parts per million (0.001 percent), as determined by the method
described in the "Food Chemicals Codex," 4th ed. (1996), pp. 760-761,
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.
(3) The whey protein concentrate shall be derived from milk that has
been pasteurized, or the whey protein concentrate shall be subjected to
pasteurization techniques or its equivalent before use in food.
(c) The whey protein concentrate may be used in food in accordance
with good manufacturing practice as indicated in Sec. 184.1(b)(1).
(d) The percent of protein present on a dry product basis, i.e.,
"whey protein concentrate (----% protein)," shall be declared on the
label of the package sold to food manufacturers. The percent of protein
may be declared in 5-percent increments, expressed as a multiple of 5,
not greater than the actual percentage of protein in the product, or as
an actual percentage provided that an analysis of the product on which
the actual percentage is based is supplied to the food manufacturer.
(e) The presence of whey protein concentrate in a finished food
product shall be listed as "whey protein concentrate".
[46 FR 44441, Sept. 4, 1981, as amended at 54 FR 24899, June 12, 1989;
64 FR 1761, 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: 21CFR184.1983]
[Page 565]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1983 Bakers yeast extract.
(a) Bakers yeast extract is the food ingredient resulting from
concentration of the solubles of mechanically ruptured cells of a
selected strain of yeast, Saccharomyces cerevisiae. It may be
concentrated or dried.
(b) The ingredient meets the following specifications on a dry
weight basis: Less than 0.4 part per million (ppm) arsenic, 0.13 ppm
cadmium, 0.2 ppm lead, 0.05 ppm mercury, 0.09 ppm selenium, and 10 ppm
zinc.
(c) The viable microbial content of the finished ingredient as a
concentrate or dry material 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 as a flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter at a level not to exceed 5
percent in food.
(e) This regulation is issued prior to general evaluation of use of
this ingredient in order to affirm as GRAS the specific use named.
[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: 21CFR184.1984]
[Page 565-566]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1984 Zein.
(a) Zein (CAS Reg. No. 9010-66-6) is one of the components of corn
gluten. It is produced commercially by extraction from corn gluten with
alkaline aqueous isopropyl alcohol containing sodium hydroxide. The
extract is then cooled, which causes the zein to precipitate.
(b) FDA is developing food-grade specifications for zein in
cooperation with the National Academy of Sciences. In the interim, the
igredient must be of a purity suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
[[Page 566]]
(1) The ingredient is used as a surface-finishing agent as defined
in Sec. 170.3(o)(30) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 8999, Mar. 6, 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: 21CFR184.1985]
[Page 566]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1985 Aminopeptidase enzyme preparation derived from lactococcus lactis.
(a) Aminopeptidase enzyme preparation is derived from the
nonpathogenic and nontoxicogenic bacterium Lactococcus lactis
(previously named Streptococcus lactis). The preparation contains the
enzyme aminopeptidase (CAS Reg. No. 9031-94-1; EC 3.4.11.1) and other
peptidases that hydrolyze milk proteins. The preparation is produced by
pure culture fermentation.
(b) The ingredient meets the specifications for enzyme preparations
in the Food Chemicals Codex, 3d ed. (1981), pp. 107-110, which are
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Division of Petition Control (HFS-215), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 1110 Vermont Ave. NW.,
suite 1200, Washington, DC, or at the Office of the Federal Register,
800 North Capitol St. NW., suite 700, Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitations other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe as a
direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an enzyme, as defined in
Sec. 170.3(o)(9) of this chapter, as an optional ingredient for flavor
development in the manufacture of cheddar cheese, in accordance with
Sec. 133.113 of this chapter, and in the preparation of protein
hydrolysates.
(2) The ingredient is used at levels not to exceed current good
manufacturing practice.
[60 FR 54193, Oct. 20, 1995]
