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73.1575 Titanium dioxide.

Home > Regulations > Listing of color additives exempt from certification > 73.1575 Titanium dioxide.






[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: 21CFR73.1575]



[Page 366-367]

 

                        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.  73.1575  Titanium dioxide.



    (a) Identity and specifications. (1) The color additive titanium 

dioxide shall conform in identity and specifications to the requirements 

of Sec.  73.575(a)(1) and (b).

    (2) Color additive mixtures for drug use made with titanium dioxide 

may contain only those diluents that are suitable and that are listed in 

this subpart as safe in color additive mixtures for coloring drugs, and 

the following: Silicon dioxide, SiO2, and/or aluminum oxide, 

Al2O3, as dispersing aids--not more than 2 percent 

total.



[[Page 367]]



    (b) Uses and restrictions. The color additive titanium dioxide may 

be used for coloring ingested and externally applied drugs generally, in 

amounts consistent with good manufacturing practice. External 

application includes use in the area of the eye.

    (c) Labeling. The label of the color additive and any mixtures 

prepared therefrom and intended solely or in part for coloring purposes 

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










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 73, Section 1575


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