(c) Uses and restrictions. Riboflavin may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice; except that it may not be used tc color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (d) Labeling. The label of the color additive shall conform to the requirements of § 8.32. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 706 (c) of the act. [32 F.R. 8853, June 22, 1967] § 8.324 Carrot oil. (a) Identity. (1) The color additive carrot oil is the liquid or the solid portion of the mixture or the mixture itself obtained by the hexane extraction of edible carrots (Daucus carota L.) with subsequent removal of the hexane by vacuum distillation. The resultant mixture of solid and liquid extractives consists chiefly of oils, fats, waxes, and carotenoids naturally occurring in carrots. The definition of carrot oil in this paragraph is for the purpose of identity as a color additive only and shall not be construed as setting forth an official standard for carrot oil or carrot oleoresin under section 401 of the act. (2) Color additive mixtures for food use made with carrot oil may contain only those diluents listed in this Subpart D as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. Carrot oil shall contain no more than 25 parts per million of hexane. (c) Uses and restrictions. Carrot oil may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless the use of added color is authorized by such standards. (d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 8.32. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 706(c) of the act. [32 F.R. 10980, July 27, 1967] Subpart-Provisional Regulations AUTHORITY: The provisions of this Subpart issued under Title II of Public Law 86-618, sec. 203 (c), (d); 74 Stat. 405; 21 U.S.C. 376, note. NOTE 1: §§ 9.1 to 9.3 of this chapter shall continue in effect, insofar as they are not inconsistent with the following provisional regulations, until new regulations for the enforcement of section 706 of the Federal Food, Drug, and Cosmetics Act basic color additives amendments of 1960 can be proposed and made effective, 25 F.R. 9759, Oct. 12, 1960. § 8.501 Provisional lists of color additives. The Commissioner of Food and Drugs finds that the following lists of color additives are provisionally listed under section 203(b) of the Color Additives Amendments of 1960 (sec. 203(b), 74 Stat. 405; 21 U.S.C. 376, note). Except for color additives for which petitions have been filed, progress reports are required by January 1, 1968, and at 6month intervals thereafter. Specifications for color additives listed in paragraphs (a), (b), and (c) of this section appear in Part 9 of this chapter. (a) Color additives previously and presently subject to certification and provisionally listed for food, drug, and cosmetic use. Closing date FD&C Green No. 3 (§ 9.23 of this chapter). FD&C Yellow No. 5 (§ 9.40 of this chapter) FD&C Yellow No. 6 (§ 9.41 of this chapter). FD&C Red No. 2 (§ 9.61 of this chapter) FD&C Red No. 3 (§ 9.62 of this chapter). FD&C Red No. 4 (§ 9.63 of this chapter). FD&C Blue No. 1 (§ 9.80 of this chapter) FD&C Blue No. 2 (§ 9.81 of this chapter). FD&C Violet No. 1 (§ 9.90 of this chapter) Lakes (FD&C) (§ 9.100 of this chapter).. (b) Color additives previously and presently subject to certification and provisionally listed for drug and cosmetic use. D&C Green No. 5 (§ 9.103 of this chapter). (c) Color additives previously and presently subject to certification and provisionally listed for use in externally applied drugs and cosmetics. Ext. D&C Yellow No. 1 (§ 9.301 of this chapter). Closing date Restrictions Dec. 31, 1967 (d) [Reserved] (e) Color additives provisionally listed for food use on the basis of prior commercial sale but which have not been nor are now subject to certification. (f) Color additives provisionally listed for drug use on the basis of prior commercial sale but which have not been nor are now subject to certification. The color additives listed in this paragraph are listed only for the uses and purposes commercially employed prior to July 12, 1960. Thus, a color additive used only in drugs for external application is not provisionally listed for internal drug use. 1 (g) Color additives provisionally listed for cosmetic use on the basis of prior commercial sale but which have not been nor are now subject to certification. The color additives provisionally listed in this paragraph are so listed only for the uses and purposes commercially employed prior to July 12, 1960. Thus, a color additive pre viously used for coloring cosmetics to be applied to portions of the body other than the eye area (as defined in § 8.1(s)) is not provisionally listed for eye-area use. [28 F.R. 317, Jan. 11, 1963, as amended at 28 F.R. 14311, Dec. 27, 1963; 30 F.R. 4535, Apr. 8, 1965; 32 F.R. 51, Jan. 5, 1967; 32 F.R. 10930, July 26, 1967; 32 F.R. 10981, July 27, 1967; 32 F.R. 11733, Aug. 15, 1967; 32 F.R. 12715, Sept. 2, 1967; 32 F.R. 12943, Sept. 12, 1967; 32 F.R. 13507, Sept. 27, 1967] § 8.502 Termination of provisional listings of color additives. (a) Ext. D&C Yellow Nos. 9 and 10. These colors cannot be produced with any assurance that they do not contain B-naphthylamine as an impurity. While it has been asserted that the two colors can be produced without the impurity named, no method of analysis has been suggested to establish the fact. B-Naphthylamine is a known carcinogen; therefore, there is no scientific evidence that will support a safe tolerance for these colors in products to be used in contact with the skin. The Commissioner of Food and Drugs, having concluded that such action is necessary to protect the public health, hereby terminates the provisional listing of Ext. D&C Yellow No. 9 and Ext. D&C Yellow No. 10 (§§ 9.309 and 9.310 of this chapter). (b) (1) D&C Red Nos. 8, 9, 10, 19, 33, 37; D&C Yellow No. 7; D&C Orange Nos. 3, 4, 5, and 17. Subacute studies have established that these colors are toxic substances, unsafe for unrestricted use in drugs and cosmetics. (2) D&C Red Nos. 11, 12, and 13. These colors are chemically related to D&C Red No. 10, being the calcium, barium, and strontium salts of the same dye, and are chemically indistinguishable from D&C Red No. 10 in the analysis of a product in which such colors have been used. They therefore must be subject to the same restrictions imposed on D&C Red No. 10. (3) D&C Yellow No. 8. This color is chemically and pharmacologically related to D&C Yellow No. 7, and therefore must be subject to any restriction imposed on that color. The Commissioner of Food and Drugs, having concluded that such action is necessary for the protection of the public health, hereby terminates the provisional listing for the colors named in this section for unrestricted use in drugs and cosmetics. These colors are now listed in Part 9 of this chapter as follows: D&C Red No. 8 (§ 9.153 of this chapter). (c) FD&C Red No. 1. Results of recent feeding tests of this color additive have demonstrated it to be toxic upon ingestion: (1) Groups of 50 rats are being fed diets containing FD&C Red No. 1 at levels of 5 percent, 2 percent, 1 percent, 0.5 percent, and 0 percent. At this stage of the tests, which have now been in progress for from 15 months to 18 months, 116 animals from the 250 being fed FD&C Red No. 1 at various levels and 27 of the 100 controls have died. Of these, 11 being fed at the 5 percent level, 16 being fed at the 2 percent level, 11 being fed at the 1 percent level, and 2 being fed at the 0.5 percent level, have shown liver damage. None of the controls that have died have shown liver damage. (2) Groups of 100 mice are being fed diets containing 2 percent, 1 percent, 0.5 percent, and 0.1 percent FD&C Red No. 1, with 400 mice as controls. All mice on dosage levels of 2 percent and 1 percent died before the seventieth week. Gross liver damage has been observed in all groups fed at the 0.5 percent diet and above. (3) Groups of 4 dogs are being fed diets containing 2 percent, 1 percent, 0.25 percent, and 0 percent FD&C Red No. 1. Three of the dogs on the 2 percent dosage level died before 32 weeks; the other is living. Three of the dogs on the 1 percent dosage level died or were sacrificed within 13 months. All deceased or sacrificed dogs have shown liver damage grossly and/or microscopically. Deceased dogs on the 1 percent and 2 percent dosage level showed poor physical condition. The Commissioner of Food and Drugs, having concluded that ingestion of this color additive over a long period of time would be unsafe, and in order to protect the public health, hereby terminates the provisional listing of FD&C Red No. 1 (§ 9.60 of this chapter) for use in foods, drugs, and cosmetics. (d) FD&C Red No. 4. Feeding tests of this color additive have been conducted with three species: (1) Rats of the Osborne-Mendel and Sprague-Dawley strains were fed FD&C Red No. 4 for 2 years at levels of 5 percent, 2 percent, 1 percent, and 0.5 percent of the diet. No effect was found. (2) Mice of the C3Hf and C57BL strains were fed FD&C Red No. 4 for 2 years at levels of 2 percent and 1 percent of the diet. No effect was found. (3) Dogs were fed FD&C Red No. 4 at levels of 2 percent and 1 percent of the diet. Adverse effects were found at both levels in the urinary bladder and in the adrenals. Three dogs of five fed on the 2-percent level died after 6 months, 9 months, and 51⁄2 years on the test. Two of the dogs on the 2-percent level and all five of the dogs on the 1-percent level survived to the completion of the 7 year study. The Commissioner of Food and Drugs has concluded that the data available to him do not permit the establishment of a safe level of use of this color additive for a long period of time in food and in ingested drugs and cosmetics. In order to protect the public health, the Commissioner hereby terminates the provisional listing of FD&C Red No. 4 (§ 9.63 of this chapter) for use in food and in drugs and cosmetics that may be ingested. The Commissioner does not find that the facts now before him require a prohibition of the use of FD&C Red No. 4 in drugs and cosmetics which are not ingested and the provisional listing with respect to these uses remains in effect. [25 F.R. 9760, Oct. 12, 1960, as amended at 25 F.R. 10600, Nov. 5, 1960, 25 F.R. 11214, Nov. 26, 1960, 26 F.R. 7579, Aug. 16, 1961, 29 F.R. 16893, Dec. 11, 1964] § 8.503 Temporary tolerances. Two-year chronic rat feeding studies, including histopathology, of D&C Red. No. 9 and D&C Red. No. 10 have been completed. A final determination of the status of these colors for ingestion must await chronic feeding studies with a nonrodent species. However, pharmacologists of the Food and Drug Administration have concluded, on the basis of chronic feeding studies with the rat, that a no-effect level of feeding of 100 parts per million will be accepted pending chronic feeding studies with a nonrodent species. Since the subacute toxicity of the two colors is of the same order of subacute toxicity as the other nine colors listed in § 8.502(b) (1), it can be assumed for the purpose of temporary tolerances that the same no-effect level of feeding for the nine colors is also 100 parts per million. Data have been submitted which indicate that the maximum amount of the color additives listed in paragraph (a) of this section likely to be ingested daily from lipstick will correspond to about 0.1 part per million in the daily diet. On this basis, it is not inconsistent with the protection of the public health to allow, during this transitional period, continued use of these products in lipstick and in other products that may be ingested in the amounts specified in this section. (a) Pursuant, therefore, to the authority in § 203(d) (1) (C) of the Color Additives Amendments of 1960, temporary tolerances are established for the following color additives: D&C Orange No. 3 (§ 9.200 of this chapter). |