21 CFR 74.3710 - D&C Yellow No. 10.

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§ 74.3710 D&C Yellow No. 10.

(a)Identity. The color additive D&C Yellow No. 10 shall conform to the identity requirements of § 74.1710(a).

(b)Specifications. The color additive D&C Yellow No. 10 for use in contact lenses shall conform to the specifications of § 74.1710(b).

(c)Uses and restrictions.

(1) The color additive D&C Yellow No. 10 may be used for coloring contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.

(2) Authorization for 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 lens in which the color additive is used.

(d)Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.

(e)Certification. All batches of D&C Yellow No. 10 shall be certified in accordance with regulations in part 80 of this chapter.

[ 52 FR 28690, Aug. 3, 1987]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

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United States Code

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 74 after this date.

  • 2017-01-23; vol. 82 # 13 - Monday, January 23, 2017
    1. 82 FR 7648 - Listing of Color Additives Exempt From Certification; Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper; Confirmation of Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; confirmation of effective date.
      Effective date of final rule published in the Federal Register of November 1, 2016 (81 FR 75689), confirmed: December 2, 2016.
      21 CFR Parts 73 and 74