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Proposition 65 Warnings Explained

Proposition 65 Warnings Explained

Proposition 65 is part of the California Health and Safety Code passed by California voters in 1986. It is also known as Prop 65 or the California Safe Drinking Water and Toxic Enforcement Act.

Prop 65 requires companies to notify the public about the presence – even at trace levels – of certain chemicals in the consumer goods they sell in California.

More than 800 substances satisfy California’s requirements for inclusion on the Prop 65 list. Some of those substances are found naturally in the environment. As a result, products with natural ingredients like minerals and herbs that naturally contain Prop 65 substances must bear a warning on their label.

Prop 65 warnings are on the labels of many everyday products and on buildings, restaurants, coffee shops, schools, hospitals, and parking garages throughout California.

A Prop 65 warning does not mean the product is unsafe1. Rather, it informs California consumers of the presence of a Prop 65 substance so they can make an informed decision when purchasing the product.

Professional Formulas has a stringent, third-party-certified quality program that includes partnering with certified outside laboratories to test incoming ingredients and finished products for purity.

Professional Formulas places a warning on the label of any product that may contain a naturally-occurring chemical exceeding the Prop 65 threshold – generally regardless of whether we are shipping it to California or elsewhere. In every case, the amount of the chemical triggering the warning will be under the limits established by other regulatory bodies like the FDA, WHO, or the U.S. Pharmacopeia.

More information about Prop 65 can be found on the California Office of Environmental Health Hazard Assessment website: http://www.oehha.ca.gov/prop65.html.

1 For many substances on the Prop 65 list, the threshold that triggers a warning does not correlate with the limits established by other regulatory bodies.

In the case of lead, for example, the FDA has established what is termed the provisional total tolerable intake level (PTTI) based on what it considers safe and tolerable daily intakes. The PTTI for pregnant women is 25 micrograms/day, or 50 times the amount requiring a Prop 65 warning. The PTTI for other adults is 75 micrograms/day, or 150 times the amount requiring a Prop 65 warning.

According to Prop 65, the daily exposure triggering a warning for a reproductive-risk chemical is determined by dividing the “no observable effect level” by 1,000. The “no observable effect level” is the maximum daily exposure that has been shown to not cause any birth defects or reproductive harm in laboratory animals or humans.

The maximum daily exposure triggering a Prop 65 warning for a cancer-risk chemical is based upon the “no significant risk level,” which is the maximum daily exposure that would result in not more than one additional case of cancer in 100,000 individuals exposed to that specific chemical every day for 70 years.