The use of colour additives in cosmetics in the USA

Under Federal Food, Drug, and Cosmetic Act (FD&C Act), a colour additive, other than colouring materials intended for use as coal-tar hair dyes, must be approved by the FDA in order to be used in cosmetic products

The Food and Drugs Administration (FDA), the competent authority for cosmetic products in the US, keeps a list of restricted and prohibited ingredient for use in cosmetics. Compared to the EU’s list of restricted and prohibited cosmetic ingredients, the FDA’s list is much shorter. However, the FDA does have a strict system of approval when it comes to colour additives. Under Federal Food, Drug, and Cosmetic Act (FD&C Act), a colour additive, other than colouring materials intended for use as coal-tar hair dyes, must be approved by the FDA in order to be used in cosmetic products. These are the only cosmetic ingredients that require pre-market approval by the FDA. The approval process also applies for colour additives used in food, dietary supplements, drugs and medical devices.

It is important to make sure that you are using an approved colour additive; otherwise, the product will be considered adulterated, and all imported products will be detained at the border.

Colour additives and their intended use

All colour additives used in a cosmetic product in the USA, have to be approved by the FDA. Additionally, some colour additives must also be batch certified by the FDA. In case there is a restriction for the use of the approved colour additive, it may be used only in line with the restrictions and for the intended use. It is very important that the additive is used only for the intended use, for which it has been approved. The regulations specifically restrict the use of colour additives in eye contour area, in externally applied cosmetics (which does not include the lips or any other mucous membrane) and for the injection (for tattooing or permanent makeup). Currently, there are no colour additives that would be approved for injection in the skin.

The approval process for different categories of colour additives

There are two main categories of colour additives – colours subject to certification and colours, which are exempt from certification. The first group of colour additives includes additives, which are derived primarily from petroleum and coal sources. If the manufacturer wants to request certification for his colour additive, he has to submit a sample of the batch for which he is requesting the certification. The FDA then tests the sample in terms of composition and purity as well as evaluates whether the colour additive is safe for its intended purpose. If the colour additive complies with the requirements, the FDA issues certification for the batch. Certified colour additives get a special name, which consists of a prefix, such as FD&C, D&C or Ext. D&C, a colour, and a number. An example is FD&C Yellow No. 6 (also known as Yellow 6).

The category of colour additives, which are exempt from batch certification, are derived mainly from plant, animal or mineral sources. An example would be caramel colour. These are not subject to certification, but they still have to comply with the regulatory requirements and safety standards for colour additives. The list of colour additives approved for use in cosmetics can be found on the FDA’s website.

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