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California Proposition 65 and Lead in Foods, Nutritionals and Pharmaceuticals

Every consumer product sold in the State of California must comply with California’s Proposition 65. Proposition 65 is a state law that requires the sellers of consumer products to warn the public when the product contains more than a certain amount of a hazardous chemical known to cause cancer and/or reproductive harm. The law does not limit how much of a hazardous chemical a product may contain, but rather stipulates that consumers must be alerted if a specified threshold is exceeded.

Lead in calcium-containing products is one of the hazardous chemicals enumerated by Proposition 65.  Manufacturers who need to review the law’s requirement carefully include those who make calcium nutritional supplements; multi-mineral supplements with significant calcium levels; pharmaceuticals, especially antacids; and foods that are to be sold in California.

The law sets different lead limits in calcium-based products, depending on whether the final product is a calcium supplement or an antacid. Producers of highly calcium-fortified foods sold in California must observe these limits as well. Note that the operative phrase here is “sold in California”—regardless of where the product is manufactured.

Specialty Minerals Inc. (SMI) offers several families of precipitated and ground calcium carbonates designed to help manufacturers meet California Proposition 65 requirements. These are the CalEssence® PCC family, the ViCALity® PCC family, and ViCALity® GF GCC. Use the link in the Learn More list below, to read about lead levels in these products.

To help formulators and manufacturers understand what is needed to comply with California Proposition 65, SMI has published a summary of the regulations and the maximum lead levels that can be in the calcium carbonate raw material used. Click on this link to download a copy of this information sheet:

Lead in Calcium–Containing Products: California Proposition 65

 

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