Tall Oil. Each of C16, C18, C20, C22, Less Than 10 (A) Tall Oil (CAS Reg

Food and Drug Administration, HHS § 186.1557

(III) oxide (CAS Reg. No. 1309–37–1, red- (c) The ingredient is used as a con- brown to black trigonal crystals). stituent of cotton and cotton fabrics (b) In accordance with § 186.1(b)(1), used for dry food packaging. the ingredient is used as an indirect (d) The ingredient is used at levels human food ingredient with no limita- not to exceed good manufacturing tion other than current good manufac- practice in accordance with § 186.1(b)(1). turing practice. The affirmation of this (e) Prior sanctions for this ingredient ingredient as generally recognized as different from the use established in safe (GRAS) as an indirect human food this section do not exist or have been ingredient is based upon the following waived. current good manufacturing practice conditions of use: [44 FR 28323, May 15, 1979, as amended at 49 (1) The ingredient is used as a con- FR 5614, Feb. 14. 1984; 58 FR 17099, Apr. 1, stituent of paper and paperboard used 1993] for food packaging. (2) The ingredient is used at levels § 186.1555 Japan wax. not to exceed current good manufac- (a) Japan wax (CAS Reg. No. 8001–39– turing practice. 6), also known as Japan tallow or (c) Prior sanctions for this ingredient sumac wax, is a pale yellow vegetable different from the uses established in tallow, containing glycerides of the this section do not exist or have been C19-C23 dibasic acids and a high content waived. of tripalmitin. It is prepared from the [53 FR 16867, May 12, 1988; 53 FR 20939, June mesocarp by hot pressing of immature 7, 1988, as amended at 69 FR 24512, May 4, fruits of the oriental sumac, Rhus 2004] succedanea (Japan, Taiwan, and Indo- China), R. vernicifera (Japan), and R. § 186.1551 Hydrogenated fish oil. trichocarpa (China, Indo-China, India, (a) Hydrogenated fish oil (CAS Reg. and Japan). Japan wax is soluble in hot No. 91078–95–4) is a class of oils pro- alcohol, benzene, and naphtha, and in- duced by partial hydrogenation of oils soluble in water and in cold alcohol. expressed from fish, primarily menha- (b) In accordance with paragraph den, and secondarily herring or tuna. (b)(1) of this section, the ingredient is Hydrogenation of fish oils uses cata- used as an indirect human food ingre- lysts composed of either elemental dient with no limitation other than nickel, elemental copper, or a mixture current good manufacturing practice. of these elements. The crude hydro- The affirmation of this ingredient as genated fish oil is further processed by generally recognized as safe (GRAS) as alkali refining, bleaching, and deodori- an indirect human food ingredient is zation by steam stripping. based on the following current good (b) Hydrogenation of fish oils results manufacturing practice conditions of in a final product with a melting point use: greater than 32 °C as determined by (1) The ingredient is used as a con- Section Cc 1–25, Official and Tentative stituent of cotton and cotton fabrics Methods of the American Oil Chemists’ used for dry food packaging. Society method (reapproved 1973) or (2) The ingredient is used at levels equivalent. The product has an approx- not to exceed current good manufac- imate fatty acid composition of 30 to 45 turing practice. percent saturated fatty acids, 40 to 55 (c) Prior sanctions for this ingredient percent monoenoic fatty acids, 7 to 15 different from the uses established in percent dienoic fatty acids, 3 to 10 per- this section do not exist or have been cent trienoic fatty acids, and less than waived. 2 percent tetraenoic or higher polyenoic fatty acids. The approximate [60 FR 62208, Dec. 5, 1995] percentages of total fatty acids by carbon chain length are 15 to 30 percent § 186.1557 Tall oil. each of C16, C18, C20, C22, less than 10 (a) Tall oil (CAS Reg. No. 8002–26–4) is percent C14 or lower carbon chain essentially the sap of the pine tree. It length, and less than 1 percent C24 or is obtained commercially from the higher carbon chain length fatty acids. waste liquors of pinewood pulp mills

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and consists mainly of tall oil resin formic acid. It is produced by the reac- acids and tall oil fatty acids. tion of carbon monoxide with sodium (b) In accordance with § 186.1(b)(1), hydroxide. the ingredient is used as an indirect (b) The ingredient is used as a con- human food ingredient with no limita- stituent of paper and paperboard used tion other than current good manufac- for food packaging. turing practice. The affirmation of this (c) The ingredient is used at levels ingredient as generally recognized as not to exceed good manufacturing safe (GRAS) as an indirect human food practice in accordance with § 186.1(b)(1). ingredient is based on the following (d) Prior sanctions for sodium for- current good manufacturing practice mate different from the uses estab- conditions of use: lished in this section do not exist or (1) The ingredient is used as a con- have been waived. stituent of cotton and cotton fabrics used for dry food packaging. [45 FR 22915, Apr. 4, 1980] (2) The ingredient is used at levels § 186.1770 Sodium oleate. not to exceed current good manufacturing practice. (a) Sodium oleate (C18H33O2Na, CAS (c) Prior sanctions for this ingredient Reg. No. 143–19–1) is the sodium salt of different from the uses established in oleic acid (cis-9-octadecenoic acid). It this section, or from those listed in exists as a white to yellowish powder part 181 of this chapter, do not exist or with a slight tallow-like odor. Com- have been waived. mercially, sodium oleate is made by mixing and heating flaked sodium hy- [51 FR 16830, May 7, 1986] droxide and oleic acid. § 186.1673 Pulp. (b) In accordance with § 186.1(b)(1), the ingredient is used as a constituent (a) Pulp is the soft, spongy pith in- of paper and paperboard for food pack- side the stem of a plant such as wood, aging and as a component of lubricants straw, sugarcane, or other natural with incidental food contact in accord- plant sources. ance with § 178.3570 of this chapter, (b) The ingredient is used or intended with no limitation other than current for use as a constituent of food pack- good manufacturing practice. aging containers. (c) Prior sanctions for this ingredient (c) The ingredient is used in paper different from the uses established in and paperboard made by conventional this section do not exist or have been paper-making processes at levels not to waived. exceed good manufacturing practice. (d) Prior sanctions for this ingredient [51 FR 39372, Oct. 28, 1986] different from the uses established in this section do not exist or have been § 186.1771 Sodium palmitate.

waived. (a) Sodium palmitate (C16H31O2Na, CAS Reg. No. 408–35–5) is the sodium § 186.1750 Sodium chlorite. salt of palmitic acid (hexadecanoic (a) Sodium chlorite (NaCLO2, CAS acid). It exists as a white to yellow Reg. No. 7758–19–2) exists as slightly powder. Commercially, sodium hygroscopic white crystals or flakes. It palmitate is made by mixing and heat- is manufactured by passing chlorine di- ing flaked sodium hydroxide and pal- oxide into a solution of sodium hydrox- mitic acid. ide and hydrogen peroxide. (b) In accordance with § 186.1(b)(1), (b) the ingredient is used at levels the ingredient is used as a constituent from 125 to 250 parts per million as a of paper and paperboard for food pack- slimicide in the manufacture of paper aging with no limitation other than and paperboard that contact food. current good manufacturing practice. [45 FR 16470, Mar. 14, 1980] (c) Prior sanctions for this ingredient different from the uses established in § 186.1756 Sodium formate. this section do not exist or have been waived. (a) Sodium formate (CHNaO2, CAS Reg. No. 141–53–7) is the sodium salt of [51 FR 39372, Oct. 28, 1986]

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