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 car- bon 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 591 VerDate Nov<24>2008 14:38 May 05, 2009 Jkt 217067 PO 00000 Frm 00601 Fmt 8010 Sfmt 8010 Y:\SGML\217067.XXX 217067 cprice-sewell on PRODPC61 with CFR.