Document vy6eqzNyZdbjk51nBYmGRXOeq

. I (4-1-90 Edition) result in adultera- tds, on the scientif ic that no action remove from the applied drugs and D&C Red No. 19 fore July 15, 1988. ; issued for D&C C Red No. 9, their xtures containing s are canceled and :rtains to their use ifrices, and ingestingested drug lip uary 6, 1987, and additives in the louthwash, dentidrugs, except inoducts, after this Alteration, ids, on the basis of ice before it, that ; taken to remove nouthwash, dentidrugs to which the re added on or 987. Ingested drug ver, are regulated ' 74.1309. for D&C Red . ixo. 9, their lakes, containing these ancelled arid have to their use in inmetic lip products ipplied drugs and 15, 1988, and use ives in the manuIrugs and cosmetic externally applied s after this date ation. ds, on the basis of ice before it, that taken to remove agested drug and ts and externally osmetics to which were added on or issued for D&C ikes, and all mixcolor additive are no effect as perigested drugs and after March 31, color additive in ingested drugs or Food and Drug Administration, HHS Part 82 ingested cosmetics after this date will result in adulteration. (2) The agency finds, on the scientif ic 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 Orange No. 17, its lakes and all mix tures containing this color additive are cancelled and have no effect as per tains to its use in externally applied drugs and cosmetics after July 15, 1988, and use of this color in the man ufacture of externally applied drugs or cosmetics after this date will result in adulteration. (4) The agency finds, on the scientif ic 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. /- --*lu)(l) Certificates issued for PD&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 a.rtr cancelled and have no effect as pertains to their use in food, drugs. and cosmetics after January 29, 19907 Certificates 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 manu facture 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 scientif ic evidence before it, that no action must be taken to remove from the market food, drugs, and cosmetics to which the provisionally listed color ad ditive or its lakes were added on or before January 29, 1990. 142 FR 15665. Mar. 22, 1977] Editorial Note: For Federal Register cita tions affecting 81.30, see the List of CFR Sections Affected in the Finding Aids sec tion of this volume. 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 addi tives in drugs and cosmetics in any other manner will result in adultera tion. Each of these color additives shah bear a label statement of the tol erance 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 colors. 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 ureen 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. li. 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. 82.1326 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. 361 21745001 BFG16379