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73.1095 β-Carotene.

Home > Regulations > Listing of color additives exempt from certification > 73.1095 β-Carotene.






[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: 21CFR73.1095]



[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.  73.1095  [beta]-Carotene.



    (a) Identity and specifications. (1) The color additive [beta]-

carotene shall conform in identity and specifications to the 

requirements of Sec.  73.95(a)(1) and (b).

    (2) The diluents in color additive mixtures for drug use containing 

[beta]-carotene are limited to those listed in this subpart as safe and 

suitable in color additive mixtures for coloring ingested drugs.

    (b) Uses and restrictions. The color additive [beta]-carotene may be 

safely used in coloring drugs generally, including those intended for 

use in the area of the eye, in amounts consistent with good 

manufacturing practice.

    (c) Labeling requirements. The labeling of the color additive 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 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 721(c) of the act.



[42 FR 15643, Mar. 22, 1977, as amended at 42 FR 33722, July 1, 1977]










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 73, Section 1095


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