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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2018]
[CITE: 21CFR186]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)
 
PART 186INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
 

Subpart B--Listing of Specific Substances Affirmed as GRAS

Sec. 186.1093 Sulfamic acid.

(a) Sulfamic acid (H3NO3S, CAS Reg. No. 5329-14-6) is a white crystalline solid manufactured from urea, sulfur trioxide, and sulfuric acid. It is soluble and highly ionized in water.

(b) In accordance with 186.1(b)(1), the ingredient is used as an indirect food ingredient with no limitations other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as an indirect human food ingredient is based upon the current good manufacturing practice of using this ingredient in the manufacture of paper and paperboard that contact food.

(c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

[47 FR 29954, July 9, 1982]

Sec. 186.1256 Clay (kaolin).

(a) Clay (kaolin) Al2O3.2SiO2.nH2O, Cas Reg. No. 1332-58-7) consists of hydrated aluminum silicate. The commercial products of clay (kaolin) contain varying quantities of alkalies and alkaline earths. Clay (kaolin) is a white to yellowish or grayish fine powder. There are at least three different minerals, kaolinite, dickite, and nacrite, classified as kaolin. Kaolinite or china clay is whiter, less contaminated with extraneous minerals, and less plastic in water.

(b) In accordance with 186.1(b)(1), the ingredient is used as an indirect human food ingredient with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as an indirect human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used in the manufacture of paper and paperboard that contact food.

(2) The ingredient is used at levels not to exceed current good manufacturing practice.

(c) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived.

[47 FR 43367, Oct. 1, 1982]

Sec. 186.1275 Dextrans.

(a) Dextrans (CAS Reg. No. 9004-54-0) are high molecular weight polysaccharides produced by bacterial fermentation of sucrose. Commercially available dextrans are synthesized from sucrose by Leuconostoc mesenteroides strain NRRL B-512(F). Partial depolymerization and purification of the fermented mixture shall produce a product that is free of viable microorganisms.

(b) The ingredient is used or intended for use as a constituent of food-contact surfaces.

(c) The ingredient is used at levels not to exceed good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

[43 FR 29288, July 7, 1978, as amended at 48 FR 48457, Oct. 19, 1983]

Sec. 186.1300 Ferric oxide.

(a) Ferric oxide (iron (III) oxide, Fe2O3, CAS Reg. No. 1309-37-1) occurs naturally as the mineral hematite. It may be prepared synthetically by heating brown iron hydroxide oxide. The product is red-brown to black trigonal crystals.

(b) In accordance with 186.1(b)(1), the ingredient is used as an indirect human food ingredient with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as an indirect human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a constituent of paper and paperboard used for food packaging.

(2) The ingredient is used at levels not to exceed current good manufacturing practice.

(c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

[53 FR 16867, May 12, 1988; 53 FR 20939, June 7, 1988]

Sec. 186.1316 Formic acid.

(a) Formic acid (CH2O2, CAS Reg. No. 64-18-6) is also referred to as methanoic acid or hydrogen carboxylic acid. It occurs naturally in some insects and is contained in the free acid state in a number of plants. Formic acid is prepared by the reaction of sodium formate with sulfuric acid and is isolated by distillation.

(b) Formic acid is used as a constituent of paper and paperboard used for food packaging.

(c) The ingredient is used at levels not to exceed good manufacturing practice in accordance with 186.1(b)(1).

(d) Prior sanctions for formic acid different from the uses established in this section do not exist or have been waived.

[45 FR 22915, Apr. 4, 1980]

Sec. 186.1374 Iron oxides.

(a) Iron oxides (oxides of iron, CAS Reg. No. 1332-37-2) are undefined mixtures of iron (II) oxide (CAS Reg. No. 1345-25-1, black cubic crystals) and iron (III) oxide (CAS Reg. No. 1309-37-1, red-brown to black trigonal crystals).

(b) In accordance with 186.1(b)(1), the ingredient is used as an indirect human food ingredient with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as an indirect human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a constituent of paper and paperboard used for food packaging.

(2) The ingredient is used at levels not to exceed current good manufacturing practice.

(c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

[53 FR 16867, May 12, 1988; 53 FR 20939, June 7, 1988, as amended at 69 FR 24512, May 4, 2004]

Sec. 186.1551 Hydrogenated fish oil.

(a) Hydrogenated fish oil (CAS Reg. No. 91078-95-4) is a class of oils produced by partial hydrogenation of oils expressed from fish, primarily menhaden, and secondarily herring or tuna. Hydrogenation of fish oils uses catalysts composed of either elemental nickel, elemental copper, or a mixture of these elements. The crude hydrogenated fish oil is further processed by alkali refining, bleaching, and deodorization by steam stripping.

(b) Hydrogenation of fish oils results in a final product with a melting point greater than 32 deg. C as determined by Section Cc 1-25, Official and Tentative Methods of the American Oil Chemists' Society method (reapproved 1973) or equivalent. The product has an approximate fatty acid composition of 30 to 45 percent saturated fatty acids, 40 to 55 percent monoenoic fatty acids, 7 to 15 percent dienoic fatty acids, 3 to 10 percent trienoic fatty acids, and less than 2 percent tetraenoic or higher polyenoic fatty acids. The approximate percentages of total fatty acids by carbon chain length are 15 to 30 percent each of C16, C18, C20, C22, less than 10 percent C14 or lower carbon chain length, and less than 1 percent C24 or higher carbon chain length fatty acids.

(c) The ingredient is used as a constituent of cotton and cotton fabrics used for dry food packaging.

(d) The ingredient is used at levels not to exceed good manufacturing practice in accordance with 186.1(b)(1).

(e) Prior sanctions for this ingredient different from the use established in this section do not exist or have been waived.

[44 FR 28323, May 15, 1979, as amended at 49 FR 5614, Feb. 14, 1984; 58 FR 17099, Apr. 1, 1993]

Sec. 186.1555 Japan wax.

(a) Japan wax (CAS Reg. No. 8001-39-6), also known as Japan tallow or sumac wax, is a pale yellow vegetable tallow, containing glycerides of the C19-C23 dibasic acids and a high content of tripalmitin. It is prepared from the mesocarp by hot pressing of immature fruits of the oriental sumac, Rhus succedanea (Japan, Taiwan, and Indo-China), R. vernicifera (Japan), and R. trichocarpa (China, Indo-China, India, and Japan). Japan wax is soluble in hot alcohol, benzene, and naphtha, and insoluble in water and in cold alcohol.

(b) In accordance with paragraph (b)(1) of this section, the ingredient is used as an indirect human food ingredient with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as an indirect human food ingredient is based on the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a constituent of cotton and cotton fabrics used for dry food packaging.

(2) The ingredient is used at levels not to exceed current good manufacturing practice.

(c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

[60 FR 62208, Dec. 5, 1995]

Sec. 186.1557 Tall oil.

(a) Tall oil (CAS Reg. No. 8002-26-4) is essentially the sap of the pine tree. It is obtained commercially from the waste liquors of pinewood pulp mills and consists mainly of tall oil resin acids and tall oil fatty acids.

(b) In accordance with 186.1(b)(1), the ingredient is used as an indirect human food ingredient with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as an indirect human food ingredient is based on the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a constituent of cotton and cotton fabrics used for dry food packaging.

(2) The ingredient is used at levels not to exceed current good manufacturing practice.

(c) Prior sanctions for this ingredient different from the uses established in this section, or from those listed in part 181 of this chapter, do not exist or have been waived.

[51 FR 16830, May 7, 1986]

Sec. 186.1673 Pulp.

(a) Pulp is the soft, spongy pith inside the stem of a plant such as wood, straw, sugarcane, or other natural plant sources.

(b) The ingredient is used or intended for use as a constituent of food packaging containers.

(c) The ingredient is used in paper and paperboard made by conventional paper-making processes at levels not to exceed good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

Sec. 186.1750 Sodium chlorite.

(a) Sodium chlorite (NaCLO2, CAS Reg. No. 7758-19-2) exists as slightly hygroscopic white crystals or flakes. It is manufactured by passing chlorine dioxide into a solution of sodium hydroxide and hydrogen peroxide.

(b) the ingredient is used at levels from 125 to 250 parts per million as a slimicide in the manufacture of paper and paperboard that contact food.

[45 FR 16470, Mar. 14, 1980]

Sec. 186.1756 Sodium formate.

(a) Sodium formate (CHNaO2, CAS Reg. No. 141-53-7) is the sodium salt of formic acid. It is produced by the reaction of carbon monoxide with sodium hydroxide.

(b) The ingredient is used as a constituent of paper and paperboard used for food packaging.

(c) The ingredient is used at levels not to exceed good manufacturing practice in accordance with 186.1(b)(1).

(d) Prior sanctions for sodium formate different from the uses established in this section do not exist or have been waived.

[45 FR 22915, Apr. 4, 1980]

Sec. 186.1770 Sodium oleate.

(a) Sodium oleate (C18H33O2Na, CAS Reg. No. 143-19-1) is the sodium salt of oleic acid (cis -9-octadecenoic acid). It exists as a white to yellowish powder with a slight tallow-like odor. Commercially, sodium oleate is made by mixing and heating flaked sodium hydroxide and oleic acid.

(b) In accordance with 186.1(b)(1), the ingredient is used as a constituent of paper and paperboard for food packaging and as a component of lubricants with incidental food contact in accordance with 178.3570 of this chapter, with no limitation other than current good manufacturing practice.

(c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

[51 FR 39372, Oct. 28, 1986]

Sec. 186.1771 Sodium palmitate.

(a) Sodium palmitate (C16H31O2Na, CAS Reg. No. 408-35-5) is the sodium salt of palmitic acid (hexadecanoic acid). It exists as a white to yellow powder. Commercially, sodium palmitate is made by mixing and heating flaked sodium hydroxide and palmitic acid.

(b) In accordance with 186.1(b)(1), the ingredient is used as a constituent of paper and paperboard for food packaging with no limitation other than current good manufacturing practice.

(c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

[51 FR 39372, Oct. 28, 1986]

Sec. 186.1797 Sodium sulfate.

(a) Sodium sulfate (Na2SO4, CAS Reg. No. 7757-82-6), also known as Glauber's salt, occurs naturally and exists as colorless crystals or as a fine, white crystalline powder. It is prepared by the neutralization of sulfuric acid with sodium hydroxide.

(b) The ingredient is used as a constituent of paper and paperboard used for food packaging, and cotton and cotton fabric used for dry food packaging.

(c) The ingredient is used at levels not to exceed good manufacturing practice in accordance with 186.1(b)(1).

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

[45 FR 6086, Jan. 25, 1980]

Sec. 186.1839 Sorbose.

(a) Sorbose (L-sorbose, sorbinose) (C6H12O6, CAS Reg. No. 87-79-6) is an orthorhombic, bisphenoidal crystalline ketohexose. It was originally identifed in the juice of mature berries from the mountain ash (Sorbus aucuparia ) where it occurs as the result of microbial oxidation of sorbitol. It also occurs naturally in other plants. Sorbose can be synthesized by the catalytic hydrogenation of glucose to D-sorbitol. The resulting sorbitol can be oxidized by Acetobacter xylinum or by Acetobacter suboxydans.

(b) The ingredient is used or intended for indirect food use as a constituent of cotton, cotton fabrics, paper, and paperboard in contact with dry food.

(c) The ingredient migrates to food at levels not to exceed good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

[43 FR 11698, Mar. 21, 1978, as amended at 48 FR 48457, Oct. 19, 1983]

Authority: 21 U.S.C. 321, 342, 348, 371.
Source: 42 FR 14658, Mar. 15, 1977, unless otherwise noted.

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