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73.3126 Titanium dioxide.

Home > Regulations > Listing of color additives exempt from certification > 73.3126 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: 21CFR73.3126]



[Page 384]

 

                        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 D_Medical Devices

 

Sec.  73.3126  Titanium dioxide.



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

(CAS Reg. No. 13463-67-7), Color Index No. 77891, shall conform in 

identity and specifications to the requirements of Sec.  73.575(a)(1) 

and (b).

    (b) Uses and restrictions. (1) The substance listed in paragraph (a) 

of this section may be used as a color additive in contact lenses in 

amounts not to exceed the minimum reasonably required to accomplish the 

intended coloring effect.

    (2) Authorization and compliance with this use shall not be 

construed as waiving any of the requirements of sections 510(k), 515, 

and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to 

the contact lenses in which the additive is used.

    (c) Labeling. The label of the color additive 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 the color additive is exempt from the certification 

requirements of section 721(c) of the act.



[51 FR 24816, July 9, 1986]










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 73, Section 3126


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