General specifications and general restrictions for provisional color additives for use in foods, drugs, and cosmetics (21 CFR 81.1-81.32)

497 Food and Drug Administration, HHS § 81.1 number through which the history of the straight color can be determined. (c) Additions to the list of diluents. A person requesting additions to the list of diluents authorized for the purposes described in paragraphs (a) and (b) of this section shall submit a petition in accordance with the provisions of § 71.1 of this chapter. Each such petition shall be accompanied by the fee pre scribed in § 70.19 of this chapter, unless there is an advance deposit to be used for prepayment of such fees. NOTE: The provisions of § 80.35 with respect only to diluents for use in cosmetic color ad ditive mixtures were stayed, until a regula tion is effected listing safe diluents for cos metic use, including cosmetics which color the human body, 29 FR 18495, Dec. 29, 1964. § 80.37 Treatment of batch pending certification. Immediately after the sample that is to accompany a request for certifi cation of a batch of color additive is taken, the batch shall be: (a) Stored in containers of such kind as to prevent change in composition. (b) Held under the control of the per son requesting certification until cer tified. (c) Marked, by labeling or otherwise, in a manner such that there can be no question as to the identity of the batch and no question that it is not to be used until the requested certificate has been issued. § 80.38 Treatment of batch after cer tification. (a) Immediately upon notification that a batch of color additive has been certified, the person requesting certifi cation thereof shall identify such batch, by labeling, with the certified lot number. (b) The person requesting certifi cation shall maintain storage in such manner as to prevent change in com position until such batch has been packaged and labeled as required by §§ 70.20 and 70.25 of this chapter, except that the person requesting certifi cation may use such color additive for the purpose of coloring a food, drug, or cosmetic. § 80.39 Records of distribution. (a) The person to whom a certificate is issued shall keep complete records showing the disposal of all the color additive from the batch covered by such certificate. Upon the request of any officer or employee of the Food and Drug Administration or of any other officer or employee acting on be half of the Secretary of Health and Human Services, such person, at all reasonable hours until at least 2 years after disposal of all such color additive, shall make such records available to any such officer or employee, and shall accord to such officer or employee full opportunity to make inventory of stocks of such color additive on hand and otherwise to check the correctness of such records. (b) The records required to be kept by paragraph (a) of this section shall show: (1) Each quantity used by such person from such batch and the date and kind of such use. (2) The date and quantity of each shipment or delivery from such batch, and the name and post-office address of the person to whom such shipment or delivery was made. (c) The records required to be kept by paragraph (a) of this section shall be kept separately from all other records. PART 81—GENERAL SPECIFICA TIONS AND GENERAL RESTRIC TIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS Sec. 81.1 Provisional lists of color additives. 81.10 Termination of provisional listings of color additives. 81.30 Cancellation of certificates. 81.32 Limitation of certificates. AUTHORITY: 21 U.S.C. 371, 379e, 379e note. § 81.1 Provisional lists of color addi tives. The Commissioner of Food and Drugs finds that the following lists of color additives are provisionally listed under section 203(b) of the Color Additive Amendments of 1960 (sec. 203(b), 74 Stat. 405 (21 U.S.C. 379e note)). Except for color additives for which petitions VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00507 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 498 21 CFR Ch. I (4–1–16 Edition) § 81.10 have been filed, progress reports are re quired by January 1, 1968, and at 6 month intervals thereafter. Specifica tions for color additives listed in para graphs (a), (b), and (c) of this section appear in the respective designated sections. The listing of color additives in this section is not to be construed as a listing for surgical suture use unless color additive petitions have been sub mitted for such use or the Commis sioner has been notified of studies un derway to establish the safety of the color additive for such use. The color additives listed in paragraphs (a), (b), and (c) of this section may not be used in products which are intended to be used in the area of the eye. The color additives listed in paragraphs (a), (b), and (c) of this section are provisionally listed until the closing dates set forth therein. (a) Color additives previously and pres ently subject to certification and provi sionally listed for food, drug, and cosmetic use. Color additive Closing date Restrictions Food use Drug and cosmetic use Lakes (FD&C) (sec. 82.51 of this chapter). (b) Color additives previously and pres ently subject to certification and provi sionally listed for drug and cosmetic use. Closing date Restrictions Lakes (D&C) (Sec. 82.2051 of this chapter). (c) Color additives previously and pres ently subject to certification and provi sionally listed for use in externally ap plied drugs and cosmetics. Closing date Restrictions Lakes (Ext. D&C) (sec. 82.105(1) of this chap ter) [42 FR 15665, Mar. 22, 1977] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 81.1, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. § 81.10 Termination of provisional list ings 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-Naph thylamine is a known carcinogen; therefore, there is no scientific evi dence that will support a safe tolerance for these colors in products to be used in contact with the skin. The Commis sioner of Food and Drugs, having con cluded that such action is necessary to protect the public health, hereby ter minated the provisional listing of Ext. D&C Yellow No. 9 and Ext. D&C Yellow No. 10. (b) [Reserved] (c) FD&C Red No. 1. Results of recent feeding tests of this color additive have demonstrated it to be toxic upon inges tion: (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 ob served in all groups fed at the 0.5 per cent 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 per cent dosage level died before 32 weeks; the other is living. Three of the dogs on the 1 percent dosage level died or were VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00508 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 499 Food and Drug Administration, HHS § 81.10 sacrificed within 13 months. All de ceased or sacrificed dogs have shown liver damage grossly and/or micro scopically. Deceased dogs on the 1 per cent 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 ter minates the provisional listing of FD&C Red No. 1 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 per cent, 2 percent, 1 percent, and 0.5 per cent 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 per cent 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 available data do not permit the establishment of a safe level of use of this color additive in food, ingested drugs and ingested cos metics. In order to protect the public health, the Commissioner hereby ter minates the provisional listing of FD&C Red No. 4 for use in food and in gested drugs. The Commissioner has previously terminated the provisional listing of FD&C Red No. 4 for use in in gested cosmetics. FD&C Red No. 4 is listed for use in externally applied drugs and cosmetics by §§ 74.1304 and 74.2304 of this chapter, respectively. Section 82.304 of this chapter is re tained in part 82 of this chapter to per mit the use of lakes of FD&C Red No. 4 in externally applied drugs and cos metics. (e) FD&C Violet No. 1. The Commis sioner of Food and Drugs, in order to protect the public health, hereby ter minates the provisional listing of FD&C Violet No. 1 for use in foods, drugs, and cosmetics. (f) FD&C Red No. 2. The Commis sioner of Food and Drugs, in order to protect the public health, hereby ter minates the provisional listing of FD&C Red No. 2 for use in food, drugs, and cosmetics. (g) Carbon black (prepared by the ‘‘im pingement’’ or ‘‘channel’’ process). The Commissioner of Food and Drugs, in order to protect the public health, hereby terminates the provisional list ing of carbon black (prepared by the impingement or channel process) for use in food, drugs, and cosmetics. (h) D&C Red Nos. 10, 11, 12, and 13. The petition for these color additives was withdrawn so that there no longer exists a basis for their continued provi sional listing. In addition, the Commis sioner has learned of the possible con tamination of D&C Red No. 10, D&C Red No. 11, D&C Red No. 12, and D&C Red No. 13 with b-naphthyl-amine. The Commissioner concludes that these colors cannot be produced with any reasonable assurance that they will not contain b-naphthylamine as an impu rity or not yield b-naphthylamine from the metabolism of subsidiary colors present in them. b-Naphthylamine is a known carcinogen; therefore, there is no scientific evidence that will support a safe tolerance for these colors in drugs or cosmetics. The Commissioner of Food and Drugs, upon withdrawal of the petition for their use and in order to protect the public health, hereby terminates the provisional listing of D&C Red No. 10, D&C Red No. 11, D&C Red No. 12, and D&C Red No. 13 for use in drugs and cosmetics, effective De cember 13, 1977. (i) Ext. D&C Yellow No. 1. The Com missioner has learned of the contami nation of Ext. D&C Yellow No. 1 with 4 aminobiphenyl. The Commissioner con cludes that this color cannot be pro duced with any reasonable assurance that it will not contain 4 aminobiphenyl as an impurity or not yield benzidine from the decomposition of a subsidiary reaction product that might be present in the color. 4 VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00509 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 500 21 CFR Ch. I (4–1–16 Edition) § 81.10 Aminobiphenyl and benzidine are known carcinogens; therefore, there is no scientific evidence that will support a safe tolerance for these colors in drugs or cosmetics. In addition, insuffi cient data have been submitted to per mit establishment of appropriate speci fications for the batch certification of the color. The Commissioner of Food and Drugs, in order to protect the pub lic health, hereby terminates the provi sional listing of Ext. D&C Yellow No. 1 for use in externally applied drugs and cosmetics, effective December 13, 1977. (j) Graphite. Data have been devel oped that show the contamination of graphite with polynuclear aromatic hy drocarbons (PNA’s). There is no reason able assurance this color can be pro duced so that it will not contain PNA’s as an impurity. The presence of certain PNA’s in graphite would indicate that PNA’s known to be carcinogenic to ani mals and humans may also be present. Therefore, there is no scientific evi dence that will support a safe tolerance for this color in drugs or cosmetics. The Commissioner of Food and Drugs, in order to protect the public health, hereby terminates the provisional list ing of graphite for use in externally ap plied cosmetics, effective November 29, 1977. (k) Ext. D&C Green No. 1. The Com missioner concludes that there are in adequate analytical methods to permit certification of the color additive Ext. D&C Green No. 1. In addition, the Com missioner has found that there was a failure to comply with the conditions attached to the postponement of the closing date in accordance with section 203(a)(2) of the transitional provisions of the Color Additive Amendments of 1960. The Commissioner of Food and Drugs hereby terminates the provi sional listing of Ext. D&C Green No. 1 for use in externally applied drugs and cosmetics, effective November 29, 1977. (l) [Reserved] (m) D&C Orange Nos. 10 and 11. In the absense of a petition to list D&C Or ange No. 10 and D&C Orange No. 11 for use in ingested drugs and cosmetics, there no longer exists a basis for provi sional listing for such uses. Therefore, FDA is terminating the provisional listing of D&C Orange No. 10 and D&C Orange No. 11 for use in ingested drugs and cosmetics, effective April 28, 1981. (n) D&C Blue No. 6. The Commis sioner of Food and Drugs, having con cluded that unresolved questions re main concerning the chemistry of un identified minor components, hereby terminates the provisional listing of D&C Blue No. 6 for use in drugs and cosmetics. (o) D&C Green No. 6. In the absence of a petition to list D&C Green No. 6 for use in ingested drugs and cosmetics, there no longer exists a basis for provi sional listing for such uses. Accord ingly, the Commissioner of Food and Drugs hereby terminates the provi sional listing of D&C Green No. 6 for use in ingested drugs and cosmetics, ef fective March 27, 1981. (p) [Reserved] (q)(1) D&C Red No. 19 and D&C Red No. 37. Having concluded that, when in gested, D&C Red No. 19 causes cancer in rats and mice, the agency hereby terminates the provisional listings of D&C Red No. 19 and chemically related D&C Red No. 37 for use in ingested drugs and ingested cosmetics, effective February 4, 1983. (2) D&C Red No. 37. In the absence of a petition to list D&C Red No. 37 for external uses, there no longer exists a basis for provisional listing for such uses. Accordingly, the Commissioner of Food and Drugs hereby terminates the provisional listings of D&C Red No. 37 for use in externally applied drugs and cosmetics, effective June 6, 1986. (r) [Reserved] (s) D&C Orange No. 17. Having con cluded that, when ingested, D&C Or ange No. 17 causes cancer in rats and mice, the agency has terminated the provisional listing of D&C Orange No. 17 for use in ingested drugs and in gested cosmetics, effective March 31, 1983. (t) D&C Red No. 8 and D&C Red No. 9. In the absence of a petition to list D&C Red No. 8 and D&C Red No. 9 for mouthwash, dentifrices, and ingested drugs, except ingested drug lip prod ucts, there no longer exists a basis for provisional listing for such uses. Ac cordingly, the Commissioner of Food and Drugs hereby terminates the provi sional listings of D&C Red No. 8 and D&C Red No. 9 for use in mouthwash, VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00510 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 501 Food and Drug Administration, HHS § 81.30 dentifrices, and ingested drugs, except ingested drug lip products, effective January 6, 1987. (u) FD&C Red No. 3. Having concluded that FD&C Red No. 3 causes cancer in rats, the agency hereby terminates the provisional listing of FD&C Red No. 3 for use in cosmetics and externally ap plied drugs and the provisional listing of the lakes of FD&C Red No. 3 for use in food, drug, and cosmetic products, effective January 29, 1990. [42 FR 15665, Mar. 22, 1977] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 81.10, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. § 81.30 Cancellation of certificates. (a) Certificates issued heretofore for colors being removed from the provi sional list (§ 81.10(a)) are cancelled and of no effect after December 1, 1960, and use of such color additives in drugs or cosmetics after that date will result in adulteration. (b)(1) Certificates issued heretofore for the color additive designated FD&C Red No. 1 are cancelled as of the date of the publication of this Order, and use of this color additive in the manu facture of foods, drugs, or cosmetics after that date will result in adultera tion. (2) The Commissioner finds that no action needs to be taken to remove foods, drugs, and cosmetics containing this color additive from the market on the basis of the scientific evidence be fore him, taking into account that the additive is not an acute toxic sub stance and that it is only used in small amounts in foods, drugs, and cos metics. (c) Certificates issued for FD&C Red No. 4 and all mixtures containing this color additive are cancelled and have no effect after September 23, 1976 inso far as food, ingested drugs, and in gested cosmetics are concerned, and use of this color additive in the manu facture of food, ingested drugs, and in gested cosmetics after this date will re sult in adulteration. The certificates shall continue in effect for the use of FD&C Red No. 4 in externally applied drugs and cosmetics. The Commis sioner finds, on the basis of the sci entific evidence before him that no ac tion has to be taken to remove from the market food, ingested drugs and in gested cosmetics containing the color additive. (d) Certificates issued for the fol lowing color additives and all mixtures containing these color additives are canceled and have no effect after Octo ber 4, 1966, and use of such color addi tives in the manufacture of foods, drugs, or cosmetics after that date will result in adulteration: FD&C Green No. 1. FD&C Green No. 2. D&C Green No. 7. D&C Red No. 5. D&C Red No. 14. D&C Red No. 18. D&C Red No. 24. D&C Red No. 29. D&C Red No. 35. D&C Red No. 38. D&C Orange No. 3. D&C Orange No. 8. D&C Orange No. 14. D&C Orange No. 15. D&C Orange No. 16. D&C Blue No. 7. D&C Black No. 1. Ext. D&C Yellow No. 5. Ext. D&C Yellow No. 6. Ext. D&C Red No. 1. Ext. D&C Red No. 2. Ext. D&C Red No. 3. Ext. D&C Red No. 10. Ext. D&C Red No. 11. Ext. D&C Red No. 13. Ext. D&C Red No. 14. Ext. D&C Red No. 15. Ext. D&C Blue No. 1. Ext. D&C Blue No. 4. Ext. D&C Orange No. 1. Ext. D&C Orange No. 4. (e) Certificates issued for the fol lowing color additives and all mixtures containing these color additives are canceled and have no effect after July 1, 1968, and use of such color additives in the manufacture of drugs or cos metics after that date will result in adulteration: Ext. D&C Yellow No. 3. Ext. D&C Red No. 8 Ext. D&C Orange No. 3. (f) Certificates issued for D&C Yellow No. 11 and all mixtures containing this color additive are canceled and have no effect after April 30, 1968, insofar as in gested use is concerned. Use of this color additive in the manufacture of VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00511 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 502 21 CFR Ch. I (4–1–16 Edition) § 81.30 ingested drugs or cosmetics subject to ingestion after that date will result in adulteration. (g) Certificates issued for D&C Red No. 17, D&C Red No. 31, D&C Red No. 34, D&C Orange No. 4, and D&C Violet No. 2, and all mixtures containing these color additives, are canceled and have no effect after December 31, 1968, insofar as ingested use is concerned. Use of these color additives in the man ufacture of ingested drugs or cosmetics subject to ingestion after that date will result in adulteration. (h)(1) Certificates issued for FD&C Violet No. 1 and all mixtures con taining this color additive are canceled and have no effect after April 10, 1973, and use of such color additive in the manufacture of foods, drugs, or cos metics after that date will result in adulteration. (2) The Commissioner finds that no action needs to be taken to remove foods, drugs, and cosmetics containing this color additive from the market on the basis of the scientific evidence be fore him. (i) Certificates issued prior to July 1, 1968, for D&C Brown No. 1 and Ext. D&C Violet No. 2 and all mixtures con taining these colors are canceled and have no effect. This cancellation does not apply to certificates issued after March 15, 1973, for D&C Brown No. 1 and Ext. D&C Violet No. 2, which are provisionally listed in § 81.1(b) and (c) respectively for coloring externally ap plied cosmetics. (j)(1) Certificates issued for FD&C Red No. 2 and all mixtures containing this color additive are canceled and have no effect after January 28, 1976, and use of this color additive in the manufacture of food, drugs, or cos metics after this date will result in adulteration. (2) The Commissioner finds, on the basis of the scientific evidence before him, that no action has to be taken to remove from the market food, drugs, and cosmetics containing the color ad ditive. (k)(1) Certificates issued for D&C Red No. 10, D&C Red No. 11, D&C Red No. 12, and D&C Red No. 13, their lakes and all mixtures containing these color ad ditives or their lakes are cancelled and have no effect after December 13, 1977, and use of these color additivies in the manufacture of drugs or cosmetics after this date will result in adultera tion. (2) The Commissioner finds, on the basis of the scientific evidence before him, that no action has to be taken to remove from the market, drug and cos metic products containing the color ad ditives. (l)(1) Certificates issued for Ext. D&C Yellow No. 1 and all mixtures con taining this color additive are can celled and have no effect after Decem ber 13, 1977, and use of this color addi tive in the manufacture of drugs or cosmetics after this date will result in adulteration. (2) The Commissioner finds, on the basis of the scientific evidence before him, that no action has to be taken to remove from the market drugs and cos metics containing the color additive. (m)(1) Certificates issued for Ext. D&C Green No. 1 and all mixtures con taining this color additive are can celled and have no effect after Novem ber 29, 1977, and use of the color addi tive in the manufacture of drugs or cosmetics after this date will result in adulteration. (2) The Commissioner finds, on the basis of the scientific evidence before him, that no action has to be taken to remove from the market drugs and cos metics containing the color additive. (n)(1) Certificates issued for D&C Or ange No. 10, D&C Orange No. 11, their lakes, and all mixtures containing these color additives are cancelled and have no effect as pertains to their use in ingested drugs and cosmetics after April 28, 1981 and use of these color ad ditives in the manufacture of ingested drugs or cosmetics after this date will result in adulteration. (2) The agency finds, on the basis of the scientific evidence before it, that no action has to be taken to remove from the market drugs and cosmetics to which the color additives were added on or before April 28, 1981. (o)(1) Certificates issued for D&C Blue No. 6 and all mixtures containing this color additive are cancelled inso far as its use in drugs and cosmetics is concerned and have no effect after De cember 13, 1977, and use of the color ad ditive in the manufacture of drugs or VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00512 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 503 Food and Drug Administration, HHS § 81.30 cosmetics after this date will result in adulteration. The color will continue to be certified for use in the coloring of surgical sutures. (2) The Commissioner finds, on the basis of the scientific evidence before him, that no action has to be taken to remove from the market drugs and cos metics containing the color additive. (p)(1) Certificates issued for D&C Green No. 6, its lakes and all mixtures containing this color additive are can celled and have no effect as pertains to their use in ingested drugs and cos metics after May 4, 1982 and use of the color additive in the manufacture of ingested drugs or cosmetics after this date will result in adulteration. (2) The agency finds, on the basis of the scientific evidence before it, that no action has to be taken to remove from the market ingested drugs and cosmetics containing the color addi tive. (q) [Reserved] (r)(1) Certificates issued for D&C Red No. 19 and D&C Red No. 37, their lakes, and all mixtures containing these color additives are cancelled and have no ef fect as pertains to their use in ingested drugs and cosmetics after February 4, 1983, and use of these color additives in the manufacture of ingested drugs or cosmetics after this date will result in adulteration. (2) The agency finds, on the scientific evidence before it, that no action has to be taken to remove from the market ingested drugs and cosmetics to which D&C Red No. 19 and D&C Red No. 37 were added on or before February 4, 1983, or externally applied drugs and cosmetics to which D&C Red No. 37 was added on or before June 6, 1986. (3) Certificates issued for D&C Red No. 37, its lakes, and all mixtures con taining this color additive are can celled and have no effect as pertains to its use in externally applied drugs and cosmetics after June 6, 1986, and use of this color additive in the manufacture of externally applied drugs or cos metics after this date will result in adulteration. (4) Certificates issued for D&C Red No. 19, its lakes, and all mixtures con taining this color additive are can celled and have no effect as pertains to its use in externally applied drugs and cosmetics after July 15, 1988, and use of this color in the manufacture of exter nally applied drugs or cosmetics after this date will result in adulteration. (5) The agency finds, on the scientific evidence before it, that no action has to be taken to remove from the market externally applied drugs and cosmetics to which D&C Red No. 19 was added on or before July 15, 1988. (s)(1) Certificates issued for D&C Red No. 8 and D&C Red No. 9, their lakes, and all mixtures containing these color additives are canceled and have no ef fect as pertains to their use in mouth wash, dentifrices, and ingested drugs, except ingested drug lip products, after January 6, 1987, and use of these color additives in the manufacture of mouth wash, dentifrices, and ingested drugs, except ingested drug lip products, after this date will result in adulteration. (2) The agency finds, on the basis of the scientific evidence before it, that no action has to be taken to remove from the market mouthwash, dentifrices, and ingested drugs to which the color additives were added on or before January 6, 1987. Ingested drug lip products, however, are regu lated for use in §§ 74.1308 and 74.1309. (3) Certificates issued for D&C Red No. 8, and D&C Red No. 9, their lakes, and all mixtures containing these color additives are cancelled and have no ef fect as pertains to their use in ingested drug and cosmetic lip products and in externally applied drugs and cosmetics after July 15, 1988, and use of these color additives in the manufacture of ingested drugs and cosmetic lip prod ucts and in externally applied drugs and cosmetics after this date will re sult in adulteration. (4) The agency finds, on the basis of the scientific evidence before it, that no action has to be taken to remove from the market ingested drug and cos metic lip products and externally ap plied drugs and cosmetics to which the color additives were added on or before July 15, 1988. (t)(1) Certificates issued for D&C Or ange No. 17, its lakes, and all mixtures containing this color additive are can celled and have no effect as pertains to its use in ingested drugs and ingested cosmetics after March 31, 1983 and use VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00513 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 504 21 CFR Ch. I (4–1–16 Edition) § 81.32 of this color additive in the manufac ture of ingested drugs or ingested cos metics after this date will result in adulteration. (2) The agency finds, on the scientific evidence before it, that no action has to be taken to remove from the market drugs and cosmetics to which the color additive was added on or before March 31, 1983. (3) Certificates issued for D&C Or ange No. 17, its lakes and all mixtures containing this color additive are can celled and have no effect as pertains to its use in externally applied drugs and cosmetics after July 15, 1988, and use of this color in the manufacture of exter nally applied drugs or cosmetics after this date will result in adulteration. (4) The agency finds, on the scientific evidence before it, that no action has to be taken to remove from the market externally applied drugs and cosmetics to which D&C Orange No. 17 was added on or before July 15, 1988. (u)(1) Certificates issued for FD&C Red No. 3 and all mixtures containing this color additive are cancelled and have no effect as pertains to their use in cosmetics and externally applied drugs after January 29, 1990. Certifi cates issued for FD&C Red No. 3 lakes and all mixtures containing these lakes are cancelled and have no effect as per tains to their use in food, drugs, and cosmetics after January 29, 1990. Cer tificates issued for D&C Red No. 3 lakes and all mixtures containing those lakes are cancelled and have no effect as pertains to their use in drugs and cosmetics after January 29, 1990. Use of this color additve in the manufacture of cosmetics and of externally applied drugs and any use of the lakes of FD&C Red No. 3 (including the lakes of D&C Red No. 3) after this date will result in adulteration. (2) The agency finds, on the scientific evidence before it, that no action must be taken to remove from the market food, drugs, and cosmetics to which the provisionally listed color additive or its lakes were added on or before Janu ary 29, 1990. [42 FR 15665, Mar. 22, 1977] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 81.30, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. § 81.32 Limitation of certificates. Certificates issued for the color addi tives listed in § 81.25 and for all mix tures containing these color additives are limited to the conditions stated in § 81.25. The use of these color additives in drugs and cosmetics in any other manner will result in adulteration. Each of these color additives shall bear a label statement of the tolerance and use limitations applicable to it. [44 FR 48966, Aug. 21, 1979] PART 82—LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS Subpart A—General Provisions Sec. 82.3 Definitions. 82.5 General specifications for straight col ors. 82.6 Certifiable mixtures. Subpart B—Foods, Drugs, and Cosmetics 82.50 General. 82.51 Lakes (FD&C). 82.101 FD&C Blue No. 1. 82.102 FD&C Blue No. 2. 82.203 FD&C Green No. 3. 82.304 FD&C Red No. 4. 82.705 FD&C Yellow No. 5. 82.706 FD&C Yellow No. 6. Subpart C—Drugs and Cosmetics 82.1050 General. 82.1051 Lakes (D&C). 82.1104 D&C Blue No. 4. 82.1205 D&C Green No. 5. 82.1206 D&C Green No. 6. 82.1254 D&C Orange No. 4. 82.1255 D&C Orange No. 5. 82.1260 D&C Orange No. 10. 82.1261 D&C Orange No. 11. 82.1306 D&C Red No. 6. 82.1307 D&C Red No. 7. 82.1317 D&C Red No. 17. 82.1321 D&C Red No. 21. 82.1322 D&C Red No. 22. 82.1327 D&C Red No. 27. 82.1328 D&C Red No. 28. 82.1330 D&C Red No. 30. 82.1331 D&C Red No. 31. 82.1333 D&C Red No. 33. 82.1334 D&C Red No. 34. 82.1336 D&C Red No. 36. 82.1602 D&C Violet No. 2. 82.1707 D&C Yellow No. 7. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00514 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B