Color Additives

When you are dealing with cosmetics, the materials you use to color your products are highly regulated. It’s important to understand what color additives are, and which ones you can use in your cosmetic products.

Back in the early part of the 20th century, when the forerunner of the FDA was investigating dangerous food additives and the Food, Drug and Cosmetic Act was just a glimmer in some peoples’ eyes, chemists in the backroom labs of pharmaceutical and chemical companies were discovering new dyes from coal tar and petroleum products. Not too long after, the soon-to-be FDA started discovering that some of those color additives were poisons, and determined they shouldn’t be used in food or drugs.

Fast forward to 1938, and with a major update to the Food, Drug and Cosmetic Act to give the FDA a bit more power over ensuring that what goes into foods, drugs and cosmetics is safe. Fast forward again to 1960, with another update to the Act, which increased the FDA’s responsibility over the safety of color additives. The FDA was given the duty to certify each batch of manufactured color additives to ensure that it was safe and met the required technical specifications. Even now, the only things that the FDA actually tests and certifies before they go on the market are color additives.

What is a “Color Additive”?

Per the Food, Drug and Cosmetic Act, a “color additive” is defined1 as:

1. 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 of identity, from a vegetable, animal, mineral, or other source, and
   
   
2. when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable(alone or through reaction with other substance) of imparting color thereto; In other words, it is anything that is CAPABLE of imparting color to the food, drug or cosmetic.

Color Additives for Cosmetics

Any ingredient that is CAPABLE of changing the color of a cosmetic is a color additive. For example, a dye, such as FD&C Blue #4 is capable of changing the color of a cosmetic - it is a color additive. Other examples: liquid chlorophyll, beta-carotene, sage powder and German Blue Chamomile essential oil can all change the color of a cosmetic.

However, - and this is a big point - only color additives that have been approved for use in cosmetics may be used in cosmetics.

In other words, if it is capable of changing the color of the cosmetic AND isn’t found on the list of color additives approved for cosmetics2, then the cosmetic using it is adulterated and considered illegal (and unsafe).

In addition, some color additives are limited in how they can be used. For example, D&C Blue #4 is approved for external use, but not for the eye area or generally (including lipsticks); D&C Red #36 may be used externally, but not in the eye area and is limited to less than 3% for use generally and in lipsticks.

Closing the Loophole

Oh, but what about ingredients that are added “for some other purpose” but still happen to change the
color of the cosmetic?

The FDA, when creating the regulations to implement the FDA Act regarding color additives, took that into account. They wrote it right into the regulations 3

(g) For a material otherwise meeting the definition of color additive to be exempt from section 721 of the act, on the basis that it is used (or intended to be used) solely for a purpose or purposes other than coloring, the material must be used in a way that any color imparted is clearly unimportant insofar as the appearance, value, marketability, or consumer acceptability is concerned. (It is not enough to warrant exemption if conditions are such that the primary purpose of the material is other than to impart color.)

In other words, an ingredient that is CAPABLE of imparting color doesn’t get exempted from the color additive rules/laws just because it is added for some other purpose. In order to be exempted from the definition of a color additive, any color that is imparted must be clearly unimportant to the appearance, value, marketability or consumer acceptability of the product.

If you added German Blue Chamomile essential oil to a lotion and it turned it a pale blue, the color
probably doesn’t have anything to do with the marketability or consumer acceptance of the product.
On the other hand, if you add liquid chlorophyll to a lotion that was packaged in green, and scented as
“fresh grass”, the green color probably would have some bearing on the appearance, value marketability
or consumer acceptability of the product.

Looking at it another way, if the color makes a difference to the product, then the color additive must be
approved for use in cosmetics at all, AND for the specific way in which the cosmetic is being used.4

Color Additives in Soap

There has been a growing movement of late to use so-called “natural colorants” in soap. You can’t use natural colorants that aren’t on the approved list of color additives in cosmetics, but there are some times when they can be used in soap.

In order to use “natural colorants” (not otherwise approved by the FDA) in soap, the soap must be exempt from the definition of a cosmetic:

1. The bulk of the non-volatile portion must be the alkali salt of fatty acids, AND
2. The surfactant properties come from the alkali salt of fatty acids, AND
3. It is marketed and labeled only as “soap”.

Provided the soap meets those criteria, the cosmetic regulations do not apply (including those concerning color additives). You could use “natural colorants” if you wanted.

But Keep in Mind ....

If the soap is a synthetic detergent based soap, it is not exempt from the definition of a cosmetic and all the color additive regulations and laws apply. You cannot use unapproved “natural colorants” in any detergent-based MP soap.

If any cosmetic claims are made for the soap (such as “moisturizing” or “soothing”), the soap is not exempt from the definition of a cosmetic and cannot contain unapproved “natural colorants.”

Finally, even if your soap is exempt from the definition of a cosmetic, you are still responsible for the safety of your soap. Consider carefully what ingredients you use to color your soap, and make sure they are safe for use. Materials such as fabric dyes, candle colorants or melted crayons shouldn’t be used in soap.

Final Thoughts

While the FDA regulations concerning color additives may seem stifling and maybe too rigid, keep in mind that the original intent of the laws and regulations were to protect people who were, in fact, being adversely affected by the color additives being used in foods, drugs and cosmetics. When considering the safety of your products, consider also the research and due diligence that has already gone into determining the safety of color additives.

Footnotes:

1 “Color additive” is defined in the FDA Act, 21 USC 321(t).

2 The list is in the regulations and on the FDA website here: https://www.fda.gov/Cosmetics/Labeling/IngredientNames/ucm109084.htm

3 21 CFR 70.3(g)

4 There is one exception that I have found so far. The FDA has not yet officially approved colored micas for use in cosmetics, but is apparently applying “discretionary enforcement.” In other words, if the mica is made with color additives that are approved, the FDA is allowing their use (by not enforcing the regulations in those instances).