FDA regulates cosmetic products and its ingredients. Color additives are added to cosmetic products to improve their appearance. Color additives are subject to strict system of approval under the FD&C Act. Failure to meet US color additive requirements may cause a cosmetic to be adulterated and make it subject to detention at the port of entry.
The FDA requirements for color additives that are added to cosmetics are as follows:
- All Color additives must be approved by FDA. There must be a regulation specifically addressing a substance use as a color additive, specifications and restrictions.
- Along with approval, many color additives are also required to be batch certified by FDA if they are to be used in cosmetics marketed in the US. This means that FDA chemists have analyzed a sample from the batch and have found that it meets the requirements for composition and purity stated in the regulation—called a “listing regulation”—for that color additive. FDA determines the need for batch certification based on whether the color additive needs this level of control to protect the public health. Some color additives, in their uncertified forms, might contain impurities at levels that pose a health concern.
- Color additives may only be used as stated in the regulations pertaining them including maximum permissible concentration in the finished product.
FD&C Act categorizes color additives into two main types:
- Those subject to certification – Petroleum based color additives aka coal tar dyes or synthetic organic colors. Such colors usually have 3-part names e.g.; FD&C Yellow No. 5
- Those exempt from certification – Obtained primarily from mineral, plant or animal sources.
A list of color additives approved for use in cosmetics can be found here https://www.fda.gov/industry/color-additives-cosmetics/color-additives-listed-use-cosmetics-code-federal-regulations
Some color additives are approved for use for one use and excluded for use in another.
To ensure that the cosmetic products do not contain any unapproved color additive or other unapproved ingredients, a manufacturer can avail LMG’s label and ingredient review service.
Namrata
FDA Regulatory Consultant
support@libertymanagement.us
Published on: July 03, 2019
Do color additives are also included in ingredient filing of a cosmetic product?
Yes, Color additives are also listed while submitting ingredient filing of any cosmetics.
If the ingredients(Color additives) in my products are in FDA GRAS list, do I still need to get approval from FDA?
FDA requires some petroleum based color additives to obtain batch certification in addition to FDA approval.