Are Your Color Additives Legal?

As I’ve discussed in previous posts (herehere and here) color additives are a major concern for the FDA. Certain color additives are subject to certification by the FDA before they can be used. Using one of those colors that is NOT certified causes your product to become “adulterated” (and therefore illegal to sell).

So how do you know if your color additives are legal?

Color additives that are subject to certification are derived primarily from petroleum products. They are sometimes referred to as “coal-tar dyes” or “synthetic-organic” colors. They include both straight colors and lakes (a straight color that has been chemically modified; lakes are generally not soluble in water).

Certified colors usually have a three-part name: 1) the prefix (FD&C, D&C or External D&C); 2) the color; and 3) the number. Examples: “FD&C Yellow No. 5” or “D&C Red No 27”

  • The color additive may be identified in the ingredient declaration for your product by just the name and number (e.g. “Yellow 5” or “Red 27”).

The full list of color additives that require certification that are approved for use in cosmetics is located here.

It is against the law to market a cosmetic product that contains a color additive that is supposed to be certified – but isn’t. 

The certification process

When a manufacturer makes a certifable color, they send a sample to the FDA where it is tested for purity, and – if it passes – is certified and given an official FDA Lot Certification Number. So far in the FDA 2018 fiscal year (October 1 to June 30), nearly 2 million pounds of color additives have been certified.

When the manufacturer packages the color additive for sale, the label must include the FDA Lot Certification Number and the color’s uses and restrictions.

Repackers

The actual manufacturers usually make very large lots of the color additive.  Repackers are companies that buy large quantities and then repack to sell in smaller amounts.

  • When the larger package is opened by the repacker it LOSES its certification and must be RE-CERTIFIED by the FDA.

As with the manufacturer, the repacker is required to inlude the FDA Lot Certification Number and the color’s uses and restrictions on the label.

Color additive certification requests

The FDA publishes a list of the companies that have requested color certification in the last two years.  Many are large companies, making big batches, but several names on the list provide smaller quantities to the handcrafted soap and cosmetic industry:

Color Blenders

Sometimes a company will purchase certified colors and then blend them to create a new color. In this case the new color doesn’t need to be certified with the FDA.

Mixtures of previously certified color additives must be labeled with the name of each ingredient in the mixture and general limitations for use. The certification lot numbers are not required, but they must have the manufacturer’s control numbers that can be used to verify the certification history of the straight colors it contains.1

How to determine if your color additive is legal

Answering these questions about your color additive help you determine if your certifiable color additive is legal. Remember, it is your responsibility to ensure that your product is not adulterated; using a color additive that isn’t approved or isn’t certified makes your product adulterated – and illegal. [Color additives exempt from certification are covered futher down in the post.]

For straight colors:

  • Does the label for the color additive contain the approved color name, FDA Lot Certification Number, general limitations for use and any other limitations or tolerances?

If your supplier doesn’t provide you with all the necessary information, you have no way to verify if the color additive is certified or how to use it. Be wary of a supplier that doesn’t or can’t provide you with the details you need to stay legal.

     
  • Is the name on the label on the list of companies that have requested certification in the past two years?

If the business name on the label isn’t on the list of companies who have requested certification in the past two years, check with your supplier to see if the color additive has, in fact, been certified by the repacker. If your supplier repacked it and didn’t get the repack certified, then any product you use it in will be adulterated – and illegal. (Keep in mind that your supplier may have purchased it already repackaged – and recertified – from another vendor.)

For mixed colors:

  • Does the label for the color mixture contain the name of each ingredient in the mixture, along with their control number, general limitations for use, and any other limitations or tolerances?

The ingredient declaration for your product must include all of the individual components of a blended ingredient. If your supplier doesn’t provide you with sufficient information, you can’t make a correct ingredient declaration. Do not purchase from a supplier that won’t give you the names of the components in a blended ingredient.

Note that for color additives, you don’t need to have the percentages of each component – color additives may all be listed at the end of your ingredient declaration, regardless of the amount.

     
  • Can your supplier provide you with the FDA Lot Certification Numbers for the component ingredients?

If you have the FDA Lot Certification Numbers for the component certified color additives, you have certainty that you are using only certified colors. It’s possible that your supplier purchased the color additive already blended and may not have the information.  But if your supplier blended the color and can’t (or won’t) give you the certification numbers, be wary – they might have used repackaged colors that lost their certification.

Remember!
If the FDA (or a local or state agency) focuses in on your products, it will be up to you to prove that the color additives you are using are legal, and that your product is not adulterated because you used colors additives that should have been certified … but weren’t.

Color additives that are exempt from certification

There are 29 color additives are sufficiently safe that they do not require certification by the FDA before they can be used.  Some have restrictions on whether they can be used in the eye area, general use (including lips and other body surface covered in mucous menbrane), or externally only. Some may be subject to limitations (for example, henna can only be used on hair on the scalp).

These are color additives that are exempt from certification that you may be familiar with:

Approved for eye area use, externally, and generally (including lipsticks):

  • Annatto
  • Bronze powder
  • Caramel
  • Carmine
  • Beta-Carotene
  • Copper Powder
  • Iron Oxides
  • Manganese violet
  • Mica
  • Titanium dioxide
  • Zinc Oxide
Approved for eye area use and externally, but NOT generally (not for lipsticks or other areas covered by mucous membranes):

  • Chromium hydroxide green
  • Chromium oxide greens
  • Ultramarines

There are other color additives that don’t require certification. You can see the full list here.

Is your exempt color additive legal?

For color additives exempt from certification:

  • Is it on the list of color additives that are exempt from certification? (here)
  • Are you using it in the manner for which it has been approved?

If you answered “no” to either of the above questions, you are using an illegal color additive.

References   [ + ]

Comments

  1. Hi Marie – Thank you again for such great information. I’ve learned so much from your posts! This topic has been a grey area for me as I’m not sure I understand where color additives in a cosmetic soap fall. Let’s say we have a soap that claims to be “moisturizing”. If I understand correctly, this claim makes it a cosmetic. I’ve always assumed that colorants for moisturizing soaps must fall into the “approved for eye area use, externally, and generally” category and those colorants in the “not for lipsticks or other areas covered by mucous membranes” must not be used. I’d love your opinion on this! Thanks again for all you do to educate us!

    1. Author

      Yes, if a soap is claimed to be moisturizing, then it is a cosmetic.

      Event though soap is a wash-off product, it does (often) come in contact with “areas covered by mucous membranes” so it would seem that color additives for use in soap would need to be approved for use “externally and generally”.

      That said, I had an email exchange with the FDA some years back about color additives for bubble bath and other in-bath products. I was told that even though the bath water is in contact with mucous membranes, since the actual amount is so diluted, it wouldn’t be prohibited. If that’s still the interpretation, then it would probably also apply to soap, especially since it is a wash-off product.

      I don’t know how to interpret whether a color additive in soap would need to be approved for “eye area” use. On the one hand, it is quite diluted and normally people try really hard not to get it in their eyes. On the other hand, some color additives – especially pigments or lakes – are not water soluable, so if they DO get into the eye, it might cause issues.

      General rule of thumb in my book is “Better safe than sorry.” Personally, I would stick to color additives that are approved for all uses (eye, general including lips and mucous membranes, and external), especially since I don’t have enough true, scientific information to evaluate the potential harm that could come to my customers. I would want to stay away from known potential harm — no matter how small the percentage of chance.

  2. Marie, thank you for sharing this information in a concise and easy-to-understand way. It’s such a complex topic that causes so much confusion. It was a joy speaking with on the phone regarding color regulations and I’m so glad knowledge about proper regulations is getting out there!

    1. Author

      It was great working with you. Your experience in working with the FDA as a repacker and getting the color additives for Nurture Soap certified was invaluable in helping me understand the process.

  3. So, liquid colorants made with FD&C colors – like Select Shades or LabColors – are those considered color blends, then? And would then be exempt from being batch certified? I know all my powders are batch certified, but never thought about the liquids. Thank you so much for all the information you share! ^_^

    1. Author

      The blended liquid colors like Select Shades or LabColors still need to be MADE with certified colors, but once they are blended they don’t need to be certified. If you are using them, you should just make sure they were made with certified colors.

  4. Thank you for your thoughtful and concise posts. I don’t see Kaolin clay on the list of “color additives that don’t require certification” on your post or the FDA’s list. It’s approved for soap use by my suppliers. Can I still post it on my ingredients?

    1. Author

      If you are using kaolin clay in your product, then it would always go in the ingredient declaration. Since it is not an approved color additive, then you can’t put it with any other approved color additives at the end of the ingredient declaration. It goes in descending order of predominance.

      Note that if it’s not on the list of approved color additives for cosmetics, then you can’t use it in a cosmetic to change the color. However, if the color is unimportant, kaolin clay (which is typically white or gray) is often used for other legitimate purposes.

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