FDA To Report Lead and Arsenic Levels for Batch Approval of Specific Colorants

November 24, 2014 | Contact Author | By: Katie Anderson
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The U.S. Food and Drug Administration (FDA) has announced that it will report specific values of lead and arsenic for a number of color additives before Certificate of Analysis (CoA) are granted for their batches.

The colorants that will be measured for lead and arseneic will include: 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 and D&C Yellow No. 10 and its lakes.

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, they issue a CoA for that batch, stating the results of its analysis. 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, it entered a result of “PT” (pass test) into the CoA.

With improvements in instrumentation and calibration techniques, the FDA will 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. If the specific value of lead or arsenic for a colorant is above the predetermined safe level, it will deny certification to the batch.

The FDA continues to work on modifying its X-ray fluorescence spectroscopy procedure from a screening method to a quantitative method so that it will be able to report more useful lead and arsenic results for all certified color additives.