Changes in the US FDA Colorants List

Colorants in the United States

The US FDA colorants list has been amended to ban Lead Acetate and add Silver Nitrate to the list of allowed colorants.

Ban of the Lead Acetate

The ban of the Lead Acetate has been officially published and will be effective from January 6th, 2022. A transition period of 12 months will be allowed by the FDA to give the opportunity to the industry to reformulate products and sell remaining products. More information is available in the Final Rule.

Addition of the Silver Nitrate

From November 8th, 2021, this colorant will be allowed to be used in cosmetics if the following uses and restrictions are respected.

The color additive silver nitrate may be safely used in externally applied professional-use only cosmetics intended to impart color to the eyebrows and eyelashes subject to the following restrictions:

  • The amount of silver nitrate in the cosmetic product shall not be more than 4 percent by weight.
  • The viscosity of the cosmetic formulation shall be not less than 120 Pascal-seconds (Pa⋅s) and not more than 180 Pa⋅s at normal temperature and pressure.
  • The cosmetic containing silver nitrate is not intended for use on persons under the age of 16.
  • Application of the cosmetic containing silver nitrate is not intended to exceed 1 minute and is intended to be followed by immediate removal.
  • The cosmetic containing silver nitrate is applied by a professional.
  • The cosmetic containing silver nitrate is not distributed or directly sold to consumers.

Moreover, the following warnings will be required on the label:

  • Contains silver nitrate.
  • Silver nitrate may permanently stain the skin with which it comes into contact.
  • Silver nitrate may irritate the eyes.
  • For application by professionals only for dyeing eyebrows and eyelashes, in accordance with the directions for use.
  • Not for use on persons under the age of 16.
  • Apply to eyebrows and eyelashes for no more than 1 minute, followed by immediate removal.
  • Rinse eyes immediately if the product comes into contact with them.
  • Consult a physician if any irritation persists.
  • Not for distribution or direct sale to consumers.

This colorant will be exempt of certification. More information about the purity criteria is available in §73.2550 of the 21 CFR.

Biorius can help you to cope with the challenging and fast-moving regulatory environment and keep you updated on this topic. Don’t hesitate to contact us for more info.

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