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182.1 Substances that are generally recognized as safe.

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[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR182.1]

[Page 466-467]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
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

Sec.
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 
          natural extracts.
182.60 Synthetic flavoring substances and adjuvants.
182.70 Substances migrating from cotton and cotton fabrics used in dry 
          food packaging.
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.
182.1180 Caffeine.
182.1217 Calcium phosphate.
182.1235 Caramel.
182.1320 Glycerin.
182.1480 Methylcellulose.
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.
182.3890 Tocopherols.

Subpart E--Emulsifying Agents [Reserved]

Subpart F--Dietary Supplements [Reserved]

[[Page 467]]

                         Subpart G_Sequestrants

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.

                          Subpart H_Stabilizers

182.7255 Chondrus extract.

                           Subpart I_Nutrients

182.8013 Ascorbic acid.
182.8159 Biotin.
182.8217 Calcium phosphate.
182.8223 Calcium pyrophosphate.
182.8250 Choline bitartrate.
182.8252 Choline chloride.
182.8778 Sodium phosphate.
182.8890 Tocopherols.
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 
reasonably possible.
    (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 
this chapter.

[42 FR 14640, Mar. 15, 1977, as amended at 53 FR 44875, Nov. 7, 1988]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 182, Section 1


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