[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 182_SUBSTANCES GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart A_General Provisions
Sec. 182.1 Substances that are generally recognized as safe.
Subpart A_General Provisions
182.1 Substances that are generally recognized as safe.
182.10 Spices and other natural seasonings and flavorings.
182.20 Essential oils, oleoresins (solvent-free), and natural
extractives (including distillates).
182.40 Natural extractives (solvent-free) used in conjunction with
spices, seasonings, and flavorings.
182.50 Certain other spices, seasonings, essential oils, oleoresins, and
182.60 Synthetic flavoring substances and adjuvants.
182.70 Substances migrating from cotton and cotton fabrics used in dry
182.90 Substances migrating to food from paper and paperboard products.
182.99 Adjuvants for pesticide chemicals.
Subpart B_Multiple Purpose GRAS Food Substances
182.1045 Glutamic acid.
182.1047 Glutamic acid hydrochloride.
182.1057 Hydrochloric acid.
182.1073 Phosphoric acid.
182.1087 Sodium acid pyrophosphate.
182.1125 Aluminum sulfate.
182.1127 Aluminum ammonium sulfate.
182.1129 Aluminum potassium sulfate.
182.1131 Aluminum sodium sulfate.
182.1217 Calcium phosphate.
182.1500 Monoammonium glutamate.
182.1516 Monopotassium glutamate.
182.1711 Silica aerogel.
182.1745 Sodium carboxymethylcellulose.
182.1748 Sodium caseinate.
182.1778 Sodium phosphate.
182.1781 Sodium aluminum phosphate.
182.1810 Sodium tripolyphosphate.
Subpart C_Anticaking Agents
182.2122 Aluminum calcium silicate.
182.2227 Calcium silicate.
182.2437 Magnesium silicate.
182.2727 Sodium aluminosilicate.
182.2729 Sodium calcium aluminosilicate, hydrated.
182.2906 Tricalcium silicate.
Subpart D_Chemical Preservatives
182.3013 Ascorbic acid.
182.3041 Erythorbic acid.
182.3089 Sorbic acid.
182.3109 Thiodipropionic acid.
182.3149 Ascorbyl palmitate.
182.3169 Butylated hydroxyanisole.
182.3173 Butylated hydroxytoluene.
182.3189 Calcium ascorbate.
182.3225 Calcium sorbate.
182.3280 Dilauryl thiodipropionate.
182.3616 Potassium bisulfite.
182.3637 Potassium metabisulfite.
182.3640 Potassium sorbate.
182.3731 Sodium ascorbate.
182.3739 Sodium bisulfite.
182.3766 Sodium metabisulfite.
182.3795 Sodium sorbate.
182.3798 Sodium sulfite.
182.3862 Sulfur dioxide.
Subpart E--Emulsifying Agents [Reserved]
Subpart F--Dietary Supplements [Reserved]
182.6085 Sodium acid phosphate.
182.6197 Calcium diacetate.
182.6203 Calcium hexametaphosphate.
182.6215 Monobasic calcium phosphate.
182.6285 Dipotassium phosphate.
182.6290 Disodium phosphate.
182.6757 Sodium gluconate.
182.6760 Sodium hexametaphosphate.
182.6769 Sodium metaphosphate.
182.6778 Sodium phosphate.
182.6787 Sodium pyrophosphate.
182.6789 Tetra sodium pyrophosphate.
182.6810 Sodium tripolyphosphate.
182.7255 Chondrus extract.
182.8013 Ascorbic acid.
182.8217 Calcium phosphate.
182.8223 Calcium pyrophosphate.
182.8250 Choline bitartrate.
182.8252 Choline chloride.
182.8778 Sodium phosphate.
182.8892 [alpha]-Tocopherol acetate.
182.8985 Zinc chloride.
182.8988 Zinc gluconate.
182.8991 Zinc oxide.
182.8994 Zinc stearate.
182.8997 Zinc sulfate.
Authority: 21 U.S.C. 321, 342, 348, 371.
Source: 42 FR 14640, Mar. 15, 1977, unless otherwise noted.
(a) It is impracticable to list all substances that are generally
recognized as safe for their intended use. However, by way of
illustration, the Commissioner regards such common food ingredients as
salt, pepper, vinegar, baking powder, and monosodium glutamate as safe
for their intended use. This part includes additional substances that,
when used for the purposes indicated, in accordance with good
manufacturing practice, are regarded by the Commissioner as generaly
recognized as safe for such uses.
(b) For the purposes of this section, good manufacturing practice
shall be defined to include the following restrictions:
(1) The quantity of a substance added to food does not exceed the
amount reasonably required to accomplish its intended physical,
nutritional, or other technical effect in food; and
(2) The quantity of a substance that becomes a component of food as
a result of its use in the manufacturing, processing, or packaging of
food, and which is not intended to accomplish any physical or other
technical effect in the food itself, shall be reduced to the extent
(3) The substance is of appropriate food grade and is prepared and
handled as a food ingredient. Upon request the Commissioner will offer
an opinion, based on specifications and intended use, as to whether or
not a particular grade or lot of the substance is of suitable purity for
use in food and would generally be regarded as safe for the purpose
intended, by experts qualified to evaluate its safety.
(c) The inclusion of substances in the list of nutrients does not
constitute a finding on the part of the Department that the substance is
useful as a supplement to the diet for humans.
(d) Substances that are generally recognized as safe for their
intended use within the meaning of section 409 of the act are listed in
this part. When the status of a substance has been reevaluated, it will
be deleted from this part, and will be issued as a new regulation under
the appropriate part, e.g., ``affirmed as GRAS'' under part 184 or 186
of this chapter; ``food additive regulation'' under parts 170 through
180 of this chapter; ``interim food additive regulation'' under part 180
of this chapter; or ``prohibited from use in food'' under part 189 of
[42 FR 14640, Mar. 15, 1977, as amended at 53 FR 44875, Nov. 7, 1988]
Additives that reference this regulation: