For Industry

Improvements to Color Additive Certificates of Analysis

In an effort to provide more useful information on the Certificates of Analysis (CoA) issued for batches of FDA-certified color additives, we have begun reporting specific values for lead and arsenic for the following color additives:

FD&C Yellow No 5 and its lakes

FD&C Yellow No 6 and its lakes

FD&C Red No 40 and its lakes

FD&C Blue No 1 and its lakes

D&C Yellow No 10 and its lakes

Background:

Under U.S. law, color additives, except coal tar hair dyes, must have FDA approval before they may be used in food, drugs, or cosmetics, or in medical devices that come in contact with the bodies of people or animals for a significant period of time.

Permitted color additives are listed in regulations that tell how they may be used, along with specifications for their content and purity, and any restrictions that apply to them.

In addition, many of these color additives may be used only if they are batch-certified by FDA. When FDA certifies a batch of a color additive, we issue a Certificate of Analysis (CoA) for that batch, stating the results of our analysis.

What’s Changed

In the past, FDA has used X-ray fluorescence spectroscopy as a screening method to determine whether or not batches of color additives met the specification limits for lead and arsenic. If a result was below the specification limit, we entered a result of “PT” (pass test) into the CoA.

With improvements in instrumentation and calibration techniques we are now able to report specific values for the colors listed above, down to a level of 2 parts per million (ppm) for lead and 1 ppm for arsenic.

For example, if we determine that there is no measurable level of lead in a sample of FD&C Yellow No. 6 submitted for certification, we report the result as <2ppm (less than 2 parts per million). If we determine that there is between 2 and 10 ppm lead, we report the level we found, for example, “3 ppm.” The specification limit for lead in FD&C Yellow No. 6 is 10 ppm. This means that if we find a level above 10 ppm, we deny certification to the batch.

We continue to work on modifying our X-ray fluorescence spectroscopy procedure from  a screening method to a quantitative method so that in the future we will be able to report more useful lead and arsenic results for all certified color additives.  

Related Resources:

 

Page Last Updated: 01/27/2015
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