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74.101 FD&C Blue No. 1.

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[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR74.101]



[Page 385-387]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 74_LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of 

Contents

 

                             Subpart A_Foods

 

Sec.  74.101  FD&C Blue No. 1.









                             Subpart A_Foods



Sec.

74.101 FD&C Blue No. 1.

74.102 FD&C Blue No. 2.

74.203 FD&C Green No. 3.

74.250 Orange B.

74.302 Citrus Red No. 2.

74.303 FD&C Red No. 3.

74.340 FD&C Red No. 40.



[[Page 386]]



74.705 FD&C Yellow No. 5.

74.706 FD&C Yellow No. 6.



                             Subpart B_Drugs



74.1101 FD&C Blue No. 1.

74.1102 FD&C Blue No. 2.

74.1104 D&C Blue No. 4.

74.1109 D&C Blue No. 9.

74.1203 FD&C Green No. 3.

74.1205 D&C Green No. 5.

74.1206 D&C Green No. 6.

74.1208 D&C Green No. 8.

74.1254 D&C Orange No. 4.

74.1255 D&C Orange No. 5.

74.1260 D&C Orange No. 10.

74.1261 D&C Orange No. 11.

74.1303 FD&C Red No. 3.

74.1304 FD&C Red No. 4.

74.1306 D&C Red No. 6.

74.1307 D&C Red No. 7.

74.1317 D&C Red No. 17.

74.1321 D&C Red No. 21.

74.1322 D&C Red No. 22.

74.1327 D&C Red No. 27.

74.1328 D&C Red No. 28.

74.1330 D&C Red No. 30.

74.1331 D&C Red No. 31.

74.1333 D&C Red No. 33.

74.1334 D&C Red No. 34.

74.1336 D&C Red No. 36.

74.1339 D&C Red No. 39.

74.1340 FD&C Red No. 40.

74.1602 D&C Violet No. 2.

74.1705 FD&C Yellow No. 5.

74.1706 FD&C Yellow No. 6.

74.1707 D&C Yellow No. 7.

74.1707a Ext. D&C Yellow No. 7.

74.1708 D&C Yellow No. 8.

74.1710 D&C Yellow No. 10.

74.1711 D&C Yellow No. 11.



                           Subpart C_Cosmetics



74.2052 D&C Black No. 2.

74.2101 FD&C Blue No. 1.

74.2104 D&C Blue No. 4.

74.2151 D&C Brown No. 1.

74.2203 FD&C Green No. 3.

74.2205 D&C Green No. 5.

74.2206 D&C Green No. 6.

74.2208 D&C Green No. 8.

74.2254 D&C Orange No. 4.

74.2255 D&C Orange No. 5.

74.2260 D&C Orange No. 10.

74.2261 D&C Orange No. 11.

74.2304 FD&C Red No. 4.

74.2306 D&C Red No. 6.

74.2307 D&C Red No. 7.

74.2317 D&C Red No. 17.

74.2321 D&C Red No. 21.

74.2322 D&C Red No. 22.

74.2327 D&C Red No. 27.

74.2328 D&C Red No. 28.

74.2330 D&C Red No. 30.

74.2331 D&C Red No. 31.

74.2333 D&C Red No. 33.

74.2334 D&C Red No. 34.

74.2336 D&C Red No. 36.

74.2340 FD&C Red No. 40.

74.2602 D&C Violet No. 2.

74.2602a Ext. D&C Violet No. 2.

74.2705 FD&C Yellow No. 5.

74.2706 FD&C Yellow No. 6.

74.2707 D&C Yellow No. 7.

74.2707a Ext. D&C Yellow No. 7.

74.2708 D&C Yellow No. 8.

74.2710 D&C Yellow No. 10.

74.2711 D&C Yellow No. 11.



                        Subpart D_Medical Devices



74.3045 [Phthalocyaninato(2-)] copper.

74.3102 FD&C Blue No. 2.

74.3106 D&C Blue No. 6.

74.3206 D&C Green No. 6.

74.3230 D&C Red No. 17.

74.3602 D&C Violet No. 2.

74.3710 D&C Yellow No. 10.



Appendix A to Part 74--The Procedure for Determining Ether Soluble 

          Material in D&C Red Nos. 6 and 7



    Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 

362, 371, 379e.



    Source: 42 FR 15654, Mar. 22, 1977, unless otherwise noted.







    (a) Identity. (1) The color additive FD&C Blue No. 1 is principally 

the disodium salt of ethyl [4-[p-[ethyl (m-sulfobenzyl) amino]-[alpha]-

(o-sulfophenyl) benzylidene] - 2,5 -cyclohexadien - 1 - ylidene] (m-

sulfobenzyl) ammonium hydroxide inner salt with smaller amounts of the 

isomeric disodium salts of ethyl [4-[p-[ethyl(p-sulfobenzyl) amino]-

[alpha]-(o-sulfophenyl) benzylidene]-2,5-cyclohexadien-1-ylidene] (p-

sulfobenzyl) ammonium hydroxide inner salt and ethyl [4-[p-[ethyl (o-

sulfobenzyl) amino] - [alpha] - (o -sulfophenyl) benzylidene]-2,5-

cyclohexadien-1-ylidene] (o-sulfobenzyl) ammonium hydroxide inner salt.

    (2) Color additive mixtures for food use (including dietary 

supplements) made with FD&C Blue No. 1 may contain only those diluents 

that are suitable and that are listed in part 73 of this chapter as safe 

for use in color additive mixtures for coloring foods.



[[Page 387]]



    (b) Specifications. FD&C Blue No. 1 shall conform to the following 

specifications and shall be free from impurities other than those named 

to the extent that such other impurities may be avoided by current good 

manufacturing practice:



Sum of volatile matter (at 135 [deg] C) and chlorides and sulfates 

(calculated as sodium salts), not more than 15.0 percent.

Water-insoluble matter, not more than 0.2 percent.

Leuco base, not more than 5 percent.

Sum of o-, m-, and p-sulfobenzaldehydes, not more than 1.5 percent.

N-Ethyl,N-(m-sulfobenzyl)sulfanilic acid, not more than 0.3 percent.

Subsidiary colors, not more than 6.0 percent.

Chromium (as Cr), not more than 50 parts per million.

Manganese (as Mn), not more than 100 parts per million.

Arsenic (as As), not more than 3 parts per million.

Lead (as Pb), not more than 10 parts per million.

Total color, not less than 85.0 percent.



    (c) Uses and restrictions. FD&C Blue No. 1 may be safely used for 

coloring foods (including dietary supplements) 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 added color is 

authorized by such standards.

    (d) Labeling. 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 Sec.  70.25 of this chapter.

    (e) Certification. All batches of FD&C Blue No. 1 shall be certified 

in accordance with regulations in part 80 of this chapter.



[42 FR 15654, Mar. 22, 1977, as amended at 58 FR 17511, Apr. 5, 1993]










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 74, Section 101


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