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FDA Requires Color Batch Certification for High Risk Color Additives

All color additives must be approved by the U.S. Food and Drug Administration (FDA) before they are used in food, drugs, cosmetics, or medical devices that come in contact with a human or animal body for a significant period of time.  What many people don’t realize is that many of these color additives also require color batch certification, which is obtained by sending a sample of a batch of color to FDA for testing.

Highly synthetic color additives have a higher risk of contamination than other additives.  These additives, for which the U.S. name begins with “FD&C” or “D&C”, are subject to color batch certification.  Color batch certification must be obtained for every individual batch of color by sending a four ounce sample of each batch to FDA.  FDA will then test the sample to ensure any contaminants contained in the batch, such as lead or arsenic, do not exceed the amount allowed.

The fee for color batch certification is based on the weight of the batch.  For straight colors, the fee is $0.35 per pound with a minimum fee of $224. The fee is nonrefundable despite whether the color batch passes or fails the certification testing.

When purchasing a color additive for use in a product that will be sold in the U.S., the purchaser should check to see if the additive requires color batch certification.  If so, the purchaser should request proof of certification before purchasing the additive.  It’s important to use the U.S. name of a color additive when researching whether or not it requires color batch certification.  For example, a commonly used color additive is named “sunset yellow” in Europe.  “Sunset yellow” translates to “FD&C Yellow #6” in the U.S., a color which requires certification.  Similarly, the commonly used additive “Allura Red” is named “FD&C Red 40” and is another that requires certification.

If FDA certifies a color batch, the agency will send the manufacturer a certificate with a lot number.  If a product is shipped to the U.S. and it contains a color additive that requires certification, FDA may contact the owner or his U.S. Agent and ask for the lot number of the color batch.  If the contact cannot provide a valid lot number, the product may be deemed adulterated and may not be allowed into the United States.

FDA has published an import alert for companies with a history of shipping foods that contain illegal color additives, including those that are uncertified.  Any company on the import alert will have its products detained without physical examination at the U.S. border.  It’s important to comply with FDA’s color batch certification requirements to avoid the delays associated with being on an import alert.

For guidance on FDA’s requirements for a specific color additive, or to submit a sample for color batch certification, contact Registrar Corp.

About the Author:  David Lennarz is Vice President of Registrar Corp, an FDA compliance firm located in Hampton, Virginia, USA.  Lennarz served as a Technical Expert for FDA’s Foreign Facility Registration Verification Program and has conducted seminars on U.S. FDA regulations in more than 30 countries around the world.