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