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Basics: Color Additives in Cosmetics [US law]

In this article, we would like to give you an informative overview about color additives and their categorisation and use in the USA. They are controlled by a strict system: Federal Food, Drug, and Cosmetic Act. Non-compliance with the US requirements for colour additives leads to a adulteration of the cosmetics.



Categories of color additives


  1. Colors subject to certification:
    These color additives are mainly derived from petroleum and are sometimes known as “coal tar dyes” or “synthetic-organic” colors. With the exception of carbon tar hair dyes, these dyes may not be used unless the FDA has confirmed that the batch in question has passed the analysis of its composition and purity.
    Certified colours usually have three-part designations. The names contain a prefix FD&C, D&C or External D&C; a color and a number (e.g. FD&C Yellow No. 5). Certified colors can also be identified in the declaration of cosmetic ingredients solely by color and number without prefix (e.g. “Yellow 5”).
  2. Colors exempt from certification:
    Colors that aren’t subject to certification are primarily extracted from minerals, plants or animal sources. However, for the use in cosmetics they still have to meet identity, specifications, uses, restrictions and labelling requirements stated in the FD&C Act.
  3. Straight Colors:
    These color additives are listed in in 21 CFR 73, 74, and 81.
  4. Lake:
    These are basically straight colors extended on a substratum by a chemical combination, absorption or coprecipitation. They are often used in lipsticks because lakes are not soluble in water.



Basic requirements


  • Approval:
    All color additives used in cosmetics have to be approved by the FDA.
  • Certification:
    Besides the approval, some color additives also must be batch certified by the FDA if they will be used in cosmetics.
  • Identity & specifications: 
    Every color additive has to the requirements for identity and specifications, defined in the Code of Federal Regulations.
  • Use & restrictions:
    Color additives are only allowed to be used for the intended uses, stated in the regulations. For certain Colors, there are also restrictions such as the maximum permissible concentration.



Source: FDA

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