21 CFR Part 182 — Substances Generally Recognized as Safe

PART 182—SUBSTANCES GENERALLY RECOGNIZED AS SAFE

Subpart A—General Provisions

§ 182.1 Substances that are generally recognized as safe.

(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 generally 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.

§ 182.10 Spices and other natural seasonings and flavorings.

Spices and other natural seasonings and flavorings that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows:

§ 182.20 Essential oils, oleoresins (solvent-free), and natural extractives (including distillates).

Essential oils, oleoresins (solvent-free), and natural extractives (including distillates) that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows:

§ 182.40 Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings.

Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows:

§ 182.50 Certain other spices, seasonings, essential oils, oleoresins, and natural extracts.

Certain other spices, seasonings, essential oils, oleoresins, and natural extracts that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows:

§ 182.60 Synthetic flavoring substances and adjuvants.

Synthetic flavoring substances and adjuvants that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows:

Acetaldehyde (ethanal). Acetoin (acetyl methylcarbinol). Anethole (parapropenyl anisole). Benzaldehyde (benzoic aldehyde). N -Butyric acid (butanoic acid). d - or l -Carvone (carvol). Cinnamaldehyde (cinnamic aldehyde). Citral (2,6-dimethyloctadien-2,6- al -8, gera-nial, neral). Decanal ( N -decylaldehyde, capraldehyde, capric aldehyde, caprinaldehyde, aldehyde C-10). Ethyl acetate. Ethyl butyrate. 3-Methyl-3-phenyl glycidic acid ethyl ester (ethyl-methyl-phenyl-glycidate, so-called strawberry aldehyde, C-16 aldehyde). Ethyl vanillin. Geraniol (3,7-dimethyl-2,6 and 3,6-octadien-1- ol ). Geranyl acetate (geraniol acetate). Limonene ( d-, l-, and dl- ). Linalool (linalol, 3,7-dimethyl-1,6-octadien-3- ol ). Linalyl acetate (bergamol). Methyl anthranilate (methyl-2-aminobenzoate). Piperonal (3,4-methylenedioxy-benzaldehyde, heliotropin). Vanillin. § 182.70 Substances migrating from cotton and cotton fabrics used in dry food packaging. Substances migrating to food from cotton and cotton fabrics used in dry food packaging that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: Beef tallow. Carboxymethylcellulose. Coconut oil, refined. Cornstarch. Gelatin. Lard. Lard oil. Oleic acid. Peanut oil. Potato starch. Sodium acetate. Sodium chloride. Sodium silicate. Sodium tripolyphosphate. Soybean oil (hydrogenated). Talc. Tallow (hydrogenated). Tallow flakes. Tapioca starch. Tetrasodium pyrophosphate. Wheat starch. Zinc chloride. § 182.90 Substances migrating to food from paper and paperboard products. Substances migrating to food from paper and paperboard products used in food packaging that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: Alum (double sulfate of aluminum and ammonium potassium, or sodium). Aluminum hydroxide. Aluminum oleate. Aluminum palmitate. Casein. Cellulose acetate. Cornstarch. Diatomaceous earth filler. Ethyl cellulose. Ethyl vanillin. Glycerin. Oleic acid. Potassium sorbate. Silicon dioxides. Sodium aluminate. Sodium chloride. Sodium hexametaphosphate. Sodium hydrosulfite. Sodium phosphoaluminate. Sodium silicate. Sodium sorbate. Sodium tripolyphosphate. Sorbitol. Soy protein, isolated. Starch, acid modified. Starch, pregelatinized. Starch, unmodified. Talc. Vanillin. Zinc hydrosulfite. Zinc sulfate. § 182.99 Adjuvants for pesticide chemicals. Adjuvants, identified and used in accordance with 40 CFR 180.910 and 40 CFR 180.920, which are added to pesticide use dilutions by a grower or applicator prior to application to the raw agricultural commodity, are exempt from the requirement of tolerances under section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348). Subpart B—Multiple Purpose GRAS Food Substances § 182.1045 Glutamic acid. (a) Product. Glutamic acid. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used as a salt substitute in accordance with good manufacturing practice. § 182.1047 Glutamic acid hydrochloride. (a) Product. Glutamic acid hydrochloride. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used as a salt substitute in accordance with good manufacturing practice. § 182.1057 Hydrochloric acid. (a) Product. Hydrochloric acid. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used as a buffer and neutralizing agent in accordance with good manufacturing practice. § 182.1073 Phosphoric acid. (a) Product. Phosphoric acid. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1087 Sodium acid pyrophosphate. (a) Product. Sodium acid pyrophosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1125 Aluminum sulfate. (a) Product. Aluminum sulfate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1127 Aluminum ammonium sulfate. (a) Product. Aluminum ammonium sulfate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1129 Aluminum potassium sulfate. (a) Product. Aluminum potassium sulfate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1131 Aluminum sodium sulfate. (a) Product. Aluminum sodium sulfate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1180 Caffeine. (a) Product. Caffeine. (b) Tolerance. 0.02 percent. (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in cola-type beverages in accordance with good manufacturing practice. § 182.1217 Calcium phosphate. (a) Product. Calcium phosphate (mono-, di-, and tribasic). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1235 Caramel. (a) Product. Caramel. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1320 Glycerin. (a) Product. Glycerin. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1480 Methylcellulose. (a) Product. U.S.P. methylcellulose, except that the methoxy content shall not be less than 27.5 percent and not more than 31.5 percent on a dry-weight basis. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1500 Monoammonium glutamate. (a) Product. Monoammonium glutamate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1516 Monopotassium glutamate. (a) Product. Monopotassium glutamate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1711 Silica aerogel. (a) Product. Silica aerogel as a finely powdered microcellular silica foam having a minimum silica content of 89.5 percent. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used as a component of an anti-foaming agent in accordance with good manufacturing practice. § 182.1745 Sodium carboxymethylcellulose. (a) Product. Sodium carboxymethylcellulose is the sodium salt of carboxymethylcellulose not less than 99.5 percent on a dry-weight basis, with maximum substitution of 0.95 carboxymethyl groups per anhydroglucose unit, and with a minimum viscosity of 25 centipoises for 2 percent by weight aqueous solution at 25 °C. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1748 Sodium caseinate. (a) Product. Sodium caseinate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1778 Sodium phosphate. (a) Product. Sodium phosphate (mono-, di-, and tribasic). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1781 Sodium aluminum phosphate. (a) Product. Sodium aluminum phosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1810 Sodium tripolyphosphate. (a) Product. Sodium tripolyphosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. Subpart C—Anticaking Agents § 182.2122 Aluminum calcium silicate. (a) Product. Aluminum calcium silicate. (b) Tolerance. 2 percent. (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in table salt in accordance with good manufacturing practice. § 182.2227 Calcium silicate. (a) Product. Calcium silicate. (b) Tolerance. 2 percent and 5 percent. (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used at levels not exceeding 2 percent in table salt and 5 percent in baking powder in accordance with good manufacturing practice. § 182.2437 Magnesium silicate. (a) Product. Magnesium silicate. (b) Tolerance. 2 percent. (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in table salt in accordance with good manufacturing practice. § 182.2727 Sodium aluminosilicate. (a) Product. Sodium aluminosilicate (sodium silicoaluminate). (b) Tolerance. This substance is generally recognized as safe for use at a level not exceeding 2 percent in accordance with good manufacturing practice. § 182.2729 Sodium calcium aluminosilicate, hydrated. (a) Product. Hydrated sodium calcium aluminosilicate (sodium calcium silicoaluminate). (b) Tolerance. This substance is generally recognized as safe for use at a level not exceeding 2 percent in accordance with good manufacturing practice. § 182.2906 Tricalcium silicate. (a) Product. Tricalcium silicate. (b) Tolerance. 2 percent. (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in table salt in accordance with good manufacturing practice. Subpart D—Chemical Preservatives § 182.3013 Ascorbic acid. (a) Product. Ascorbic acid. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.3041 Erythorbic acid. (a) Product. Erythorbic acid. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.3089 Sorbic acid. (a) Product. Sorbic acid. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.3109 Thiodipropionic acid. (a) Product. Thiodipropionic acid. (b) Tolerance. This substance is generally recognized as safe for use in food when the total content of antioxidants is not over 0.02 percent of fat or oil content, including essential (volatile) oil content of the food, provided the substance is used in accordance with good manufacturing practice. § 182.3149 Ascorbyl palmitate. (a) Product. Ascorbyl palmitate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.3169 Butylated hydroxyanisole. (a) Product. Butylated hydroxyanisole. (b) Tolerance. This substance is generally recognized as safe for use in food when the total content of antioxidants is not over 0.02 percent of fat or oil content, including essential (volatile) oil content of food, provided the substance is used in accordance with good manufacturing practice. § 182.3173 Butylated hydroxytoluene. (a) Product. Butylated hydroxytoluene. (b) Tolerance. This substance is generally recognized as safe for use in food when the total content of antioxidants is not over 0.02 percent of fat or oil content, including essential (volatile) oil content of food, provided the substance is used in accordance with good manufacturing practice. § 182.3189 Calcium ascorbate. (a) Product. Calcium ascorbate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.3225 Calcium sorbate. (a) Product. Calcium sorbate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.3280 Dilauryl thiodipropionate. (a) Product. Dilauryl thiodipropionate. (b) Tolerance. This substance is generally recognized as safe for use in food when the total content of antioxidants is not over 0.02 percent of fat or oil content, including essential (volatile) oil content of the food, provided the substance is used in accordance with good manufacturing practice. § 182.3616 Potassium bisulfite. (a) Product. Potassium bisulfite. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in accordance with good manufacturing practice, except that it is not used in meats; in food recognized as a source of vitamin B 1 ; on fruits and vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh. § 182.3637 Potassium metabisulfite. (a) Product. Potassium metabisulfite. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in accordance with good manufacturing practice, except that it is not used in meats; in food recognized as a source of vitamin B 1 ; on fruits and vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh. § 182.3640 Potassium sorbate. (a) Product. Potassium sorbate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.3731 Sodium ascorbate. (a) Product. Sodium ascorbate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.3739 Sodium bisulfite. (a) Product. Sodium bisulfite. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in accordance with good manufacturing practice, except that it is not used in meats; in food recognized as a source of vitamin B 1 ; on fruits or vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to the consumer as fresh. § 182.3766 Sodium metabisulfite. (a) Product. Sodium metabisulfite. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in accordance with good manufacturing practice, except that it is not used in meats; in food recognized as a source of vitamin B 1 ; on fruits or vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh. § 182.3795 Sodium sorbate. (a) Product. Sodium sorbate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.3798 Sodium sulfite. (a) Product. Sodium sulfite. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in accordance with good manufacturing practice, except that it is not used in meats; in food recognized as a source of vitamin B 1 ; on fruits or vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh. § 182.3862 Sulfur dioxide. (a) Product. Sulfur dioxide. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in accordance with good manufacturing practice, except that it is not used in meats; in food recognized as a source of vitamin B 1 ; on fruits or vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh. § 182.3890 Tocopherols. (a) Product. Tocopherols. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. Subpart E—Emulsifying Agents [Reserved] Subpart F—Dietary Supplements [Reserved] Subpart G—Sequestrants 1 § 182.6085 Sodium acid phosphate. (a) Product. Sodium acid phosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6197 Calcium diacetate. (a) Product. Calcium diacetate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6203 Calcium hexametaphosphate. (a) Product. Calcium hexametaphosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6215 Monobasic calcium phosphate. (a) Product. Monobasic calcium phosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6285 Dipotassium phosphate. (a) Product. Dipotassium phosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6290 Disodium phosphate. (a) Product. Disodium phosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6757 Sodium gluconate. (a) Product. Sodium gluconate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6760 Sodium hexametaphosphate. (a) Product. Sodium hexametaphosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6769 Sodium metaphosphate. (a) Product. Sodium metaphosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6778 Sodium phosphate. (a) Product. Sodium phosphate (mono-, di-, and tribasic). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6787 Sodium pyrophosphate. (a) Product. Sodium pyrophosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6789 Tetra sodium pyrophosphate. (a) Product. Tetra sodium pyrophosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6810 Sodium tripolyphosphate. (a) Product. Sodium tripolyphosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. Subpart H—Stabilizers § 182.7255 Chondrus extract. (a) Product. Chondrus extract (carrageenin). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. Subpart I—Nutrients § 182.8013 Ascorbic acid. (a) Product. Ascorbic acid. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.8159 Biotin. (a) Product. Biotin. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.8217 Calcium phosphate. (a) Product. Calcium phosphate (mono-, di-, and tribasic). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.8223 Calcium pyrophosphate. (a) Product. Calcium pyrophosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.8250 Choline bitartrate. (a) Product. Choline bitartrate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.8252 Choline chloride. (a) Product. Choline chloride. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.8778 Sodium phosphate. (a) Product. Sodium phosphate (mono-, di-, and tribasic).