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 Dec 3, 2018 ; Apr 1, 2019 84 FR 12081 Final Rule Apr 1, 2019 ; Oct 8, 2021 86 FR 56183 Final rule; response to objections and denial of public hearing requests; removal of administrative stay. 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)