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73.1100 Cochineal extract; carmine.

Home > Regulations > Listing of color additives exempt from certification > 73.1100 Cochineal extract; carmine.






[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: 21CFR73.1100]



[Page 359]

 

                        TITLE 21--FOOD AND DRUGS

 

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

                                SERVICES

 

PART 73_LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table 

of Contents

 

                             Subpart B_Drugs

 

Sec.  73.1100  Cochineal extract; carmine.



    (a) Identity and specifications. (1) The color additives cochineal 

extract and carmine shall conform in identity and specifications to the 

requirements of Sec.  73.100(a) (1) and (2) and (b).

    (2) Color additive mixtures for drug use made with carmine and 

cochineal extract may contain only those diluents that are suitable and 

that are listed in this subpart as safe in color additive mixtures for 

coloring drugs.

    (b) Uses and restrictions. Cochineal extract and carmine may be 

safely used for coloring ingested and externally applied drugs in 

amounts consistent with good manufacturing practice.

    (c) Labeling requirements. The label of the color additives and any 

mixtures intended solely or in part for coloring purposes prepared 

therefrom shall conform to the requirements of Sec.  70.25 of this 

chapter.

    (d) Exemption from certification. Certification of these color 

additives is not necessary for the protection of the public health, and 

therefore batches thereof are exempt from the certification requirements 

of section 721(c) of the act.



[[Page 360]]










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 73, Section 1100


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