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U.S. Department of Health and Human Services

Final Rules: Food Additives and Color Additives
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Petition(s): CAP 7C0311

Listing of Color Additives Subject to Certification; D&C Yellow No. 8

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.
Petitioner: Glo Eyes, LLC
Docket number (legacy and/or former docket number(s)): FDA-2017-C-2902
Subject additive and intended use: amending the color additive regulations to provide for the expanded safe use of D&C Yellow No. 8 as a color additive in contact lens solution.
21 CFR* affected: 74.3708; D&C Yellow No. 8.
Substance(s)*, (CAS Registry® No.):
  • D&C Yellow No. 8, (518-47-8)
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    Federal Register publication history: May 31, 2017; 82 FR 24912; Notice of petition
    Sep 25, 2018; 83 FR 48373; Final Rule; Effective date: Oct 26, 2018
    Dec 17, 2018; 83 FR 64443; Final Rule; Confirmation of Effective Date; Effective date: Oct 26, 2018


    *See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

    **More about Environmental Decisions and Definitions of Environmental Terms.
    See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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