Color Additives

Color additives are strictly regulated, and many cannot be used unless the color comes from a batch certified by the FDA. Manufacturers must assure that each color additive complies with the identity, specifications, labeling requirements, use, and restrictions of color additive regulations. With the exception of coal-tar hair dyes, all color additives whether or not they are subject to certification, must be approved by the FDA for their intended use.

TechLink International Consultants have performed hundreds of approvals with the FDA for color additives.

The specifications are divided into four parts:

• Approval. All color additives used in cosmetics (or any other FDA-regulated product) must be approved by the 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 the FDA if they are to be used in cosmetics (or any other FDA-regulated product) marketed in the U.S.
• 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.

TechLink International receives the updates of the review panel first hand, and makes sure all of our clients receive a copy of it.

We keep our clients informed, since the major reason for container detentions at the port is noncompliance with these standards.

Avoid these serious consequences by complying with the correct procedures from the beginning.

Contact us today for more details.