Understanding US FDA Regulations for Cosmetic Color Additives

I always suggest a review of regulations as the first step in selecting color additives for use in making cosmetics. Colorant regulations can limit the use to certain cosmetic applications and percentages and can also vary by the country in which the product is sold. I recently watched a formulator scramble to replace D&C Red 7 Lake in an eye shadow color at the last minute after realizing it’s not permitted for eye area use in the United States. 

US Color Regulations

There are two important definitions to consider when interpreting the color additive regulations for cosmetics.  These include the terms ‘cosmetic’ and ‘color additive.’  According the US Food and Drug Administration (FDA) the term cosmetic means

articles intended to be rubbed, poured, sprinkles or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance and articles intended for use as a component of any such articles; except that term shall not include soap.

And the definition of color additive is

…any material, not exempted under section 201(t) of the Food, Drug, and Cosmetic Act, that is a dye, pigment or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change in identity, from a vegetable, animal, mineral or other source and that when added to a food, drug, or cosmetic or to the human body or any part thereof, is capable (alone or through reaction with another substance) of imparting color thereto.

In the United States, the permanent list of approved colors is divided into two categories.

Certifiable Color: The list of certifiable colors is comprised of synthetic, organic colorants. A sample of each batch of these additives must be sent to the FDA for analysis. If the batch meets required purity standards the FDA issues a certification number to the manufacturer. The manufacturer of the colorant must display the certification number on the label of the package in which the color additive is shipped and on all associated paperwork. In addition, the cosmetic company that purchases certified color additives must keep a record of where the batch of colorant was used in production.

Exempt Colors: Batch certification of exempt colors is not required, but purity specifications must adhered to by manufacturers and consumers of these colorants. This category is primarily comprised of inorganic pigments, but there are exceptions like carmine, which is the aluminum or calcium-aluminum lake on an aluminum hydroxide substrate of carminic acid.

The FDA’s website is a great resource for information on color regulations. The following will be useful:

Table of permitted color additives
Basic requirements for cosmetic color additives

If you have any questions, feel free to leave a comment below.

3 thoughts on “Understanding US FDA Regulations for Cosmetic Color Additives

  1. Avatar
    Ryan Nelson says:

    Hi Kelly. There’s been recent talk online (https://www.insider.com/fda-might-consider-neon-makeup-unsafe-around-eyes-2019-7) about color cosmetics marketed for use around eyes, but labeled as not for eye-area use in accordance with FDA’s color additive regs. Color additives require specific authorization from FDA for eye-area use. If they do not have this approval, does this necessarily reflect safety hazards? Is FDA primarily concerned about sensitivity reactions in some users, or what exactly is the concern? Are some approved (but not eye area-approved) color additives known to be more problematic than others from an eye health standpoint? Thanks.

  2. Avatar
    Kelly Dobos says:

    Hello Ryan
    Cosmetic pigment regulations in the US and many other countries note that they safety of the pigments needs to be substantiated. If there is a use area restriction it is likely a safety issue, for example most red pigments are not permitted in the eye area. No new pigments have been added to the FDA’s list in years so if a pigment is not on that list safety has not been substantiated. Toxicological testing would be likely needed through animal studies. Use of animal studies has been banned in the EU with a cut off date of March 11, 2013, so that would severely limit sales.

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