21 CFR 73.1030 - Annatto extract.

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There are 2 Updates appearing in the Federal Register for 21 CFR 73. View below or at eCFR (GPOAccess)
§ 73.1030 Annatto extract.
(a) Identity and specifications.
(1) The color additive annatto extract shall conform in identity and specifications to the requirements of § 73.30(a)(1) and (b).
(2) Color additive mixtures for drug use made with annatto extract may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring ingested drugs.
(b) Uses and restrictions. Annatto extract may be safely used for coloring drugs generally, including those intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(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 § 70.25 of this chapter. Labels shall bear information showing that the color is derived from annatto seed. The requirements of § 70.25(a) of this chapter that all ingredients shall be listed by name shall not be construed as requiring the declaration of residues of solvents listed in § 73.30(a)(1)(ii) 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 evempt from the certification requirements of section 721(c) of the act.
[42 FR 15643, Mar. 22, 1977, as amended at 42 FR 36994, July 19, 1977]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-06-11; vol. 79 # 112 - Wednesday, June 11, 2014
    1. 79 FR 33431 - Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; confirmation of effective date.
      The effective date for the final rule published April 11, 2014 (79 FR 20095), is confirmed as May 13, 2014.
      21 CFR Part 73

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 73 after this date.

  • 2014-06-11; vol. 79 # 112 - Wednesday, June 11, 2014
    1. 79 FR 33431 - Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; confirmation of effective date.
      The effective date for the final rule published April 11, 2014 (79 FR 20095), is confirmed as May 13, 2014.
      21 CFR Part 73