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According to the Federal Food, Drug, and 3011游戏平台客户端 Act (FD&C Act), all color additives must obtain 3011游戏平台客户端 approval before they can be used in food, drugs, cosmetics, and medical devices intended for sale in the United States. To sell new color additives or use approved color additives for new purposes, manufacturers must first submit an application to the 3011游戏平台客户端.

The FD&C Act Section 721(c) and color additive regulations separate approved color additives into two main categories: those subject to certification (sometimes called "certifiable") and those exempt from certification.

3011游戏平台客户端s subject to certification - These color additives are derived primarily from petroleum and are sometimes known as "coal-tar dyes" or "synthetic-organic" colors. 3011游戏平台客户端 additives must be batch certified by 3011游戏平台客户端 if they are to be used in cosmetics (or any other 3011游戏平台客户端-regulated product) marketed in the U.S. 3011游戏平台客户端 additives must pass analysis of its composition and purity in 3011游戏平台客户端's own labs. For color additives that have passed batch certification but have been repackaged, repackaging batch certification is also required.

3011游戏平台客户端s exempt from certification - These color additives are obtained primarily from mineral, plant, or animal sources. They are not subject to batch certification requirements. However, they still are considered artificial colors, and when used in cosmetics or other 3011游戏平台客户端-regulated products, they must comply with the identity, specifications, uses, restrictions, and labeling requirements stated in the regulations.

3011游戏平台客户端 certification

When applying for batch certification, manufacturers are required to submit color additive samples and corresponding documents to the 3011游戏平台客户端. All foreign companies in the United States must designate a 3011游戏平台客户端 agent in the batch certification application.


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