Title 21 CFR reference

(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…

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: Table | Common name | Botanical name of plant source | | --- | --- | | Alfalfa herb and seed | Medicago sativa L. | | Allspice | Pimenta officinalis Lindl. | | Ambrette seed | Hibiscus abelmoschus L. | | Angelica | Angelica archangelica L. or other spp. of Angelica. | | Angelica root | Do. | | Angelica seed | Do. | | Angostura (cusparia bark) | Galipea officinalis Hancock. | | Anise | Pimpinella anisum L. | | Anise, star | Illicium verum Hook. f. | | Balm (lemon balm) | Melissa officinalis L. | | Basil, bush | Ocimum minimum L. | | Basil, sweet | Ocimum basilicum L. | | Bay | Laurus nobilis L. | | Calendula | Calendula officinalis L. | | Camomile (chamomile), English or Roman | Anthemis nobilis L. | | Camomile (chamomile), German or Hungarian | Matricaria chamomilla L. | | Capers | Capparis spinosa L. | | Capsicum | Capsicum frutescens L. or Capsicum annuum L. | | Caraway | Carum carvi L. | | Caraway, black (black cumin) | Nigella sativa L. | | Cardamom (cardamon) | Elettaria cardamomum Maton. | | Cassia,…

Product.(a) Glutamic acid. (b) [Reserved] Limitations, restrictions, or explanation.(c) This substance is generally recognized as safe when used as a salt substitute in accordance with good manufacturing practice.

Product.(a) Glutamic acid hydrochloride. (b) [Reserved] Limitations, restrictions, or explanation.(c) This substance is generally recognized as safe when used as a salt substitute in accordance with good manufacturing practice.

Product.(a) Hydrochloric acid. (b) [Reserved] Limitations, restrictions, or explanation.(c) This substance is generally recognized as safe when used as a buffer and neutralizing agent in accordance with good manufacturing practice.

Product.(a) Phosphoric acid. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Sodium acid pyrophosphate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Aluminum sulfate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Aluminum ammonium sulfate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Aluminum potassium sulfate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Aluminum sodium sulfate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Caffeine. Tolerance.(b) 0.02 percent. Limitations, restrictions, or explanation.(c) This substance is generally recognized as safe when used in cola-type beverages in accordance with good manufacturing practice.

Product.(a) Calcium phosphate (mono-, di-, and tribasic). Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Caramel. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Glycerin. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) 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. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Monoammonium glutamate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Monopotassium glutamate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Silica aerogel as a finely powdered microcellular silica foam having a minimum silica content of 89.5 percent. (b) [Reserved] Limitations, restrictions, or explanation.(c) This substance is generally recognized as safe when used as a component of an anti-foaming agent in accordance with good manufacturing practice.

Product.(a) 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. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Sodium caseinate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Sodium phosphate (mono-, di-, and tribasic). Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Sodium aluminum phosphate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Sodium tripolyphosphate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

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: Table | Common name | Botanical name of plant source | | --- | --- | | Alfalfa | Medicago sativa L. | | Allspice | Pimenta officinalis Lindl. | | Almond, bitter (free from prussic acid) | Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.) Batsch. | | Ambrette (seed) | Hibiscus moschatus Moench. | | Angelica root | Angelica archangelica L. | | Angelica seed | Do. | | Angelica stem | Do. | | Angostura (cusparia bark) | Galipea officinalis Hancock. | | Anise | Pimpinella anisum L. | | Asafetida | Ferula assa-foetida L. and related spp. of Ferula. | | Balm (lemon balm) | Melissa officinalis L. | | Balsam of Peru | Myroxylon pereirae Klotzsch. | | Basil | Ocimum basilicum L. | | Bay leaves | Laurus nobilis L. | | Bay (myrcia oil) | Pimenta racemosa (Mill.) J. W. Moore. | | Bergamot (bergamot orange) | Citrus aurantium L. subsp. bergamia Wright et Arn. | | Bitter almond (free from prussic acid) | Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus…

Product.(a) Aluminum calcium silicate. Tolerance.(b) 2 percent. Limitations, restrictions, or explanation.(c) This substance is generally recognized as safe when used in table salt in accordance with good manufacturing practice.

Product.(a) Calcium silicate. Tolerance.(b) 2 percent and 5 percent. Limitations, restrictions, or explanation.(c) 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.

Product.(a) Magnesium silicate. Tolerance.(b) 2 percent. Limitations, restrictions, or explanation.(c) This substance is generally recognized as safe when used in table salt in accordance with good manufacturing practice.

Product.(a) Sodium aluminosilicate (sodium silicoaluminate). Tolerance.(b) This substance is generally recognized as safe for use at a level not exceeding 2 percent in accordance with good manufacturing practice.

Product.(a) Hydrated sodium calcium aluminosilicate (sodium calcium silicoaluminate). Tolerance.(b) This substance is generally recognized as safe for use at a level not exceeding 2 percent in accordance with good manufacturing practice.

Product.(a) Tricalcium silicate. Tolerance.(b) 2 percent. Limitations, restrictions, or explanation.(c) This substance is generally recognized as safe when used in table salt in accordance with good manufacturing practice.

Product.(a) Ascorbic acid. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Erythorbic acid. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Sorbic acid. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Thiodipropionic acid. Tolerance.(b) 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.

Product.(a) Ascorbyl palmitate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Butylated hydroxyanisole. Tolerance.(b) 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.

Product.(a) Butylated hydroxytoluene. Tolerance.(b) 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.

Product.(a) Calcium ascorbate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Calcium sorbate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Dilauryl thiodipropionate. Tolerance.(b) 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.

Product.(a) Potassium bisulfite. (b) [Reserved] Limitations, restrictions, or explanation.152(c) 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; on fruits and vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]

Product.(a) Potassium metabisulfite. (b) [Reserved] Limitations, restrictions, or explanation.152(c) 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; on fruits and vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]

Product.(a) Potassium sorbate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Sodium ascorbate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Sodium bisulfite. (b) [Reserved] Limitations, restrictions, or explanation.152(c) 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; 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. [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]

Product.(a) Sodium metabisulfite. (b) [Reserved] Limitations, restrictions, or explanation.152(c) 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; on fruits or vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9833, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]

Product.(a) Sodium sorbate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Sodium sulfite. (b) [Reserved] Limitations, restrictions, or explanation.152(c) 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; on fruits or vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]

Product.(a) Sulfur dioxide. (b) [Reserved] Limitations, restrictions, or explanation.152(c) 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; on fruits or vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]

Product.(a) Tocopherols. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

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: Table | Common name | Botanical name of plant source | | --- | --- | | Apricot kernel (persic oil) | Prunus armeniaca L. | | Peach kernel (persic oil) | Prunus persica Sieb. et Zucc. | | Peanut stearine | Arachis hypogaea L. | | Persic oil (see apricot kernel and peach kernel) | | Quince seed | Cydonia oblonga Miller. | [42 FR 14640, Mar. 15, 1977, as amended at 47 FR 47375, Oct. 26, 1982]

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: Table | Common name | Derivation | | --- | --- | | Ambergris | Physeter macrocephalus L. | | Castoreum | Castor fiber L. and C. canadensis Kuhl. | | Civet (zibeth, zibet, zibetum) | Civet cats, Viverra civetta Schreber and Viverra zibetha Schreber. | | Cognac oil, white and green | Ethyl oenanthate, so-called. | | Musk (Tonquin musk) | Musk deer, Moschus moschiferus L. |

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: [42 FR 14640, Mar. 15, 1977, as amended at 43 FR 47724, Oct. 17, 1978; 44 FR 3963, Jan. 19, 1979; 44 FR 20656, Apr. 6, 1979; 48 FR 51907, Nov. 15, 1983; 54 FR 7402, Feb. 21, 1989]

Product.(a) Sodium acid phosphate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Calcium diacetate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Calcium hexametaphosphate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Monobasic calcium phosphate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Dipotassium phosphate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Disodium phosphate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Sodium gluconate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Sodium hexametaphosphate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Sodium metaphosphate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Sodium phosphate (mono-, di-, and tribasic). Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Sodium pyrophosphate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Tetra sodium pyrophosphate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Sodium tripolyphosphate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

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: [42 FR 14640, Mar. 15, 1977, as amended at 43 FR 11698, Mar. 21, 1978; 44 FR 28323, May 15, 1979; 45 FR 6085, Jan. 25, 1980; 47 FR 27807, 27814, June 25, 1982; 48 FR 51150, Nov. 7, 1983; 48 FR 51616, Nov. 10, 1983; 48 FR 51909, Nov. 15, 1983; 48 FR 52441, 52443, 52445, 52446, Nov. 18, 1983; 51 FR 16830, May 7, 1986; 51 FR 27171, July 30, 1986; 60 FR 62208, Dec. 5, 1995]

Product.(a) Chondrus extract (carrageenin). Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Ascorbic acid. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Biotin. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Calcium phosphate (mono-, di-, and tribasic). Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Calcium pyrophosphate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Choline bitartrate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Choline chloride. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Sodium phosphate Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice. (mono-, di-, and tribasic).

Product.(a) Tocopherols. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) α-Tocopherol acetate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Zinc chloride. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Zinc gluconate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Zinc oxide. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Zinc stearate prepared from stearic acid free from chickedema factor. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Product.(a) Zinc sulfate. Conditions of use.(b) This substance is generally recognized as safe when used in accordance with good manufacturing practice.

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: [42 FR 14640, Mar. 15, 1977] Federal Register04www.govinfo.gov.For citations affecting § 182.90, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at

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). [76 FR 59249, Sept. 26, 2011]