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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 7C0309

Termination of Listing of Color Additive Exempt From Certification; Lead Acetate

Petitioner: Environmental Defense Fund, Earthjustice, Environmental Working Group, Center for Environmental Health, Healthy Homes Collaborative, Health Justice Project of Loyola University Chicago School of Law, Breast Cancer Fund, Improving Kids' Environment, Consumers Union, Natural Resources Defense Council, Consumer Federation of America, Learning Disabilities Association, Maricel Maffini, and Howard Mielke
Docket number (legacy and/or former docket number(s)): FDA-2017-C-1951
Subject additive and intended use: amending the color additive regulations to no longer provide for the use of lead acetate in cosmetics intended for coloring hair on the scalp because new data available since lead acetate was permanently listed demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive.
21 CFR* affected: 73.2396; Lead acetate.
Substance(s)*, (CAS Registry® No.):
  • trihydrate of lead (2+) salt of acetic acid, (6080-56-4)
  • Federal Register publication history: Apr 4, 2017; 82 FR 16321; Notice of petition
    Oct 31, 2018; 83 FR 54665; Final Rule; Effective date: Dec 3, 2018
    Apr 1, 2019; 84 FR 12081; Final Rule; Effective date: Apr 1, 2019
    Oct 8, 2021; 86 FR 56183; Final rule; response to objections and denial of public hearing requests; removal of administrative stay.; Effective date: Jan 6, 2022

     

    *Definitions

    • 21 CFR: Title 21 of the Code of Federal Regulations.
    • Substance: The name of the substance listed in the CFR.
    • CAS Registry® No.: Chemical Abstract Service (CAS) Registry Number® for the substance.
    • Petitions (see also Questions and Answers About the Petition Process)
      • FAP: Food Additive Petition
      • CAP: Color Additive Petition
      • GRP: GRAS Affirmation Petition (replaced by GRAS Notification Program in 1998)
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