Article by: Kelly Dobos

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, sprinkled 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.

If your product contains a color additive, by law you must adhere to requirements for:

– Approval. All color additives used in cosmetics (or any other FDA-regulated product) must be approved by FDA. There must be a regulation specifically addressing a substance’s use as a color additive, specifications, and restrictions.

– Certification. In addition to approval, a number of color additives must be batch certified by FDA if they are to be used in cosmetics (or any other FDA-regulated product) marketed in the U.S.

• FDA’s regulations regarding certified color additives are quite strict. A certification number should be provided by the supplier for every lot colorant. Without a certification number from the FDA certifiable pigments should not be used. Any company that repackages lots of certified color additives, should obtain “repack” certification for those smaller lots.

• Once a batch of color is certified, it is up to the owner of the certificate to make sure that the material does not change in composition until the package of color is opened and used. That is why only the owner of the certificate can package and label the material. If FDA allowed the owner of the certificate to sell the color to a repacking facility, there would be no control over the composition of the color additive. The FDA allows “repack” certification which includes analysis of the material again to ensure that it hasn’t changed in composition.

– Identity and specifications. All color additives must meet the requirements for identity and specifications stated in the Code of Federal Regulations (CFR).

– Use and restrictions. Color additives may be used only for the intended uses stated in the regulations that pertain to them. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product.

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Kelly Dobos

About the Author

Kelly Dobos

Kelly Dobos is a cosmetic chemist and expert in both skin care and make-up product formulation. She has the coolest job and a passion for teaching others the smartest ways to express their creativity through cosmetic chemistry.

One comment

  1. WAQAR INSHA KITCHLEW

    Dear kelly thank you very much for providing very critical information regarding FDA Regulations about colors your passion of teaching others through cosmetic chemistry
    though i am purely from opposite area of product design but i have a great passion for
    creative products in personal care area and want to learn from your experience of cosmetic chemistry looking forward for your reply
    Regards
    waqar

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