[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1]
[Page 479-482]
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 A_General Provisions
Sec. 184.1 Substances added directly to human food affirmed as generally
recognized as safe (GRAS).
Subpart A_General Provisions
Sec.
184.1 Substances added directly to human food affirmed as generally
recognized as safe (GRAS).
Subpart B_Listing of Specific Substances Affirmed as GRAS
184.1005 Acetic acid.
184.1007 Aconitic acid.
184.1009 Adipic acid.
184.1011 Alginic acid.
184.1012 [alpha]-Amylase enzyme preparation from Bacillus
stearothermophilus.
184.1021 Benzoic acid.
184.1024 Bromelain.
184.1025 Caprylic acid.
184.1027 Mixed carbohydrase and protease enzyme product.
184.1033 Citric acid.
184.1034 Catalase (bovine liver).
184.1061 Lactic acid.
184.1063 Enzyme-modified lecithin.
184.1065 Linoleic acid.
184.1069 Malic acid.
184.1077 Potassium acid tartrate.
184.1081 Propionic acid.
184.1090 Stearic acid.
184.1091 Succinic acid.
184.1095 Sulfuric acid.
184.1097 Tannic acid.
184.1099 Tartaric acid.
184.1101 Diacetyl tartaric acid esters of mono- and diglycerides.
184.1115 Agar-agar.
184.1120 Brown algae.
184.1121 Red algae.
184.1133 Ammonium alginate.
184.1135 Ammonium bicarbonate.
184.1137 Ammonium carbonate.
184.1138 Ammonium chloride.
184.1139 Ammonium hydroxide.
184.1140 Ammonium citrate, dibasic.
184.1141a Ammonium phosphate, monobasic.
184.1141b Ammonium phosphate, dibasic.
184.1143 Ammonium sulfate.
184.1148 Bacterially-derived carbohydrase enzyme preparation.
184.1150 Bacterially-derived protease enzyme preparation.
184.1155 Bentonite.
184.1157 Benzoyl peroxide.
184.1165 n-Butane and iso-butane.
184.1185 Calcium acetate.
184.1187 Calcium alginate.
184.1191 Calcium carbonate.
184.1193 Calcium chloride.
184.1195 Calcium citrate.
184.1199 Calcium gluconate.
184.1201 Calcium glycerophosphate.
184.1205 Calcium hydroxide.
184.1206 Calcium iodate.
184.1207 Calcium lactate.
184.1210 Calcium oxide.
184.1212 Calcium pantothenate.
184.1221 Calcium propionate.
184.1229 Calcium stearate.
184.1230 Calcium sulfate.
184.1240 Carbon dioxide.
184.1245 Beta-carotene.
184.1250 Cellulase enzyme preparation derived from Trichoderma longi
brachi atum.
184.1257 Clove and its derivatives.
184.1259 Cocoa butter substitute.
184.1260 Copper gluconate.
184.1261 Copper sulfate.
184.1262 Corn silk and corn silk extract.
184.1265 Cuprous iodide.
184.1271 L-Cysteine.
184.1272 L-Cysteine monohydrochloride.
184.1277 Dextrin.
184.1278 Diacetyl.
184.1282 Dill and its derivatives.
184.1287 Enzyme-modified fats.
184.1293 Ethyl alcohol.
184.1295 Ethyl formate.
184.1296 Ferric ammonium citrate.
184.1297 Ferric chloride.
184.1298 Ferric citrate.
184.1301 Ferric phosphate.
184.1304 Ferric pyrophosphate.
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184.1307 Ferric sulfate.
184.1307a Ferrous ascorbate.
184.1307b Ferrous carbonate.
184.1307c Ferrous citrate.
184.1307d Ferrous fumarate.
184.1308 Ferrous gluconate.
184.1311 Ferrous lactate.
184.1315 Ferrous sulfate.
184.1316 Ficin.
184.1317 Garlic and its derivatives.
184.1318 Glucono delta-lactone.
184.1321 Corn gluten.
184.1322 Wheat gluten.
184.1323 Glyceryl monooleate.
184.1324 Glyceryl monostearate.
184.1328 Glyceryl behenate.
184.1329 Glyceryl palmitostearate.
184.1330 Acacia (gum arabic).
184.1333 Gum ghatti.
184.1339 Guar gum.
184.1343 Locust (carob) bean gum.
184.1349 Karaya gum (sterculia gum).
184.1351 Gum tragacanth.
184.1355 Helium.
184.1366 Hydrogen peroxide.
184.1370 Inositol.
184.1372 Insoluble glucose isomerase enzyme preparations.
184.1375 Iron, elemental.
184.1386 Isopropyl citrate.
184.1387 Lactase enzyme preparation from Candida pseudotropicalis.
184.1388 Lactase enzyme preparation from Kluyveromyces lactis.
184.1400 Lecithin.
184.1408 Licorice and licorice derivatives.
184.1409 Ground limestone.
184.1415 Animal lipase.
184.1420 Lipase enzyme preparation derived from Rhizopus niveus.
184.1425 Magnesium carbonate.
184.1426 Magnesium chloride.
184.1428 Magnesium hydroxide.
184.1431 Magnesium oxide.
184.1434 Magnesium phosphate.
184.1440 Magnesium stearate.
184.1443 Magnesium sulfate.
184.1443a Malt.
184.1444 Maltodextrin.
184.1445 Malt syrup (malt extract).
184.1446 Manganese chloride.
184.1449 Manganese citrate.
184.1452 Manganese gluconate.
184.1461 Manganese sulfate.
184.1472 Menhaden oil.
184.1490 Methylparaben.
184.1498 Microparticulated protein product.
184.1505 Mono- and diglycerides.
184.1521 Monosodium phosphate derivatives of mono- and diglycerides.
184.1530 Niacin.
184.1535 Niacinamide.
184.1537 Nickel.
184.1538 Nisin preparation.
184.1540 Nitrogen.
184.1545 Nitrous oxide.
184.1553 Peptones.
184.1555 Rapeseed oil.
184.1560 Ox bile extract.
184.1563 Ozone.
184.1583 Pancreatin.
184.1585 Papain.
184.1588 Pectins.
184.1595 Pepsin.
184.1610 Potassium alginate.
184.1613 Potassium bicarbonate.
184.1619 Potassium carbonate.
184.1622 Potassium chloride.
184.1625 Potassium citrate.
184.1631 Potassium hydroxide.
184.1634 Potassium iodide.
184.1635 Potassium iodate.
184.1639 Potassium lactate.
184.1643 Potassium sulfate.
184.1655 Propane.
184.1660 Propyl gallate.
184.1666 Propylene glycol.
184.1670 Propylparaben.
184.1676 Pyridoxine hydrochloride.
184.1685 Rennet (animal-derived) and chymosin preparation (fermentation-
derived).
184.1695 Riboflavin.
184.1697 Riboflavin-5'-phosphate (sodium).
184.1698 Rue.
184.1699 Oil of rue.
184.1702 Sheanut oil.
184.1721 Sodium acetate.
184.1724 Sodium alginate.
184.1733 Sodium benzoate.
184.1736 Sodium bicarbonate.
184.1742 Sodium carbonate.
184.1751 Sodium citrate.
184.1754 Sodium diacetate.
184.1763 Sodium hydroxide.
184.1764 Sodium hypophosphite.
184.1768 Sodium lactate.
184.1769a Sodium metasilicate.
184.1784 Sodium propionate.
184.1792 Sodium sesquicarbonate.
184.1801 Sodium tartrate.
184.1804 Sodium potassium tartrate.
184.1807 Sodium thiosulfate.
184.1835 Sorbitol.
184.1845 Stannous chloride (anhydrous and dihydrated).
184.1848 Starter distillate.
184.1851 Stearyl citrate
184.1854 Sucrose.
184.1857 Corn sugar.
184.1859 Invert sugar.
184.1865 Corn syrup.
184.1866 High fructose corn syrup.
184.1875 Thiamine hydrochloride.
184.1878 Thiamine mononitrate.
184.1890 [alpha]-Tocopherols.
184.1901 Triacetin.
184.1903 Tributyrin.
184.1911 Triethyl citrate.
184.1914 Trypsin.
184.1923 Urea.
184.1924 Urease enzyme preparation from Lactobacillus fermentum.
184.1930 Vitamin A.
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184.1945 Vitamin B12.
184.1950 Vitamin D.
184.1973 Beeswax (yellow and white).
184.1976 Candelilla wax.
184.1978 Carnauba wax.
184.1979 Whey.
184.1979a Reduced lactose whey.
184.1979b Reduced minerals whey.
184.1979c Whey protein concentrate.
184.1983 Bakers yeast extract.
184.1984 Zein.
184.1985 Aminopeptidase enzyme preparation derived from lactococcus
lactis.
Authority: 21 U.S.C. 321, 342, 348, 371.
Source: 42 FR 14653, Mar 15, 1977, unless otherwise noted.
Editorial Note: Nomenclature changes to part 184 appear at 66 FR
56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, 2001, 68 FR 15355, Mar. 31,
2003, and 69 FR 13717, Mar. 24, 2004.
(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.
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(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]