Cosmetic colorants are additives used to alter the color of cosmetics or enhance their vibrancy. To ensure consumer health and safety, many countries have strict regulations regarding using these colorants. Below are some key rules and requirements:

List of Permissible Colorants:
Governments typically publish a list of approved colorants, specifying which can be used in cosmetics. For example, China’s “Cosmetic Safety Technical Specifications” (2015 edition) lists 157 permitted colorants, all of which have undergone rigorous toxicity testing to ensure their safety.
Scope of Use and Concentration Limits:
The scope of use for colorants is strictly limited based on their safety and characteristics. For instance, some colorants are only allowed in specific types of cosmetics, such as skincare products or makeup. Additionally, there are clear regulations on the maximum allowable concentration for each colorant to prevent harm to human health. These limits are based on detailed risk assessments, ensuring that even long-term use remains safe. For example, in the EU, the maximum allowable concentration for CI 15985 is 0.5%, while in the United States, its concentration in cosmetics cannot exceed 1.5%.
Labeling Requirements:
Cosmetics containing specific colorants must indicate relevant information on their labels, including the name of the colorant, usage conditions, and precautions. If the concentration of a certain colorant exceeds specified standards, this must also be explicitly stated. This helps consumers understand product ingredients and make informed choices. For example, a lipstick containing CI 42090 must clearly label its concentration if it exceeds 0.1%.
Prohibitions and Restrictions:
Certain colorants are prohibited in specific types of cosmetics, such as eye products or hair dyes, due to potential health risks. Additionally, some colorants may be restricted under certain conditions; for example, in Japan, CI 19140 (Yellow 6) is not permitted in eye cosmetics to prevent possible allergic reactions.
Batch Certification and Regulation:
In some countries, such as the United States, specific colorants must undergo batch certification by the FDA to ensure their quality and safety. Colorants that have not been certified cannot be used in cosmetic production. This regulatory measure ensures that only colorants meeting high safety standards can enter the market. For example, CI 77491 (Iron Oxide Red) must be FDA-certified before it can be used in products like sunscreens and foundations.
Record Keeping and Compliance:
Manufacturers and suppliers must maintain detailed records, including information on the use of colorants, batch details, sources, and compliance documentation. These records typically need to be kept for at least two years for regulatory inspections. This helps trace and ensure that every link in the supply chain meets safety standards. For instance, in South Korea, all manufacturers using CI 14700 (Azo Red) must keep relevant records to demonstrate compliance with safety and regulatory requirements.
Through these regulations, cosmetic regulatory agencies around the world strive to ensure that the colorants used in cosmetics are safe and reliable, protecting consumers from potential harmful substances. Manufacturers and suppliers should strictly adhere to these regulations to ensure the compliance and safety of their products. Consumers can also make safer choices by understanding this information and selecting cosmetics that are suitable for their needs.