Proposition 65 previously known as “The safe drinking Water and Toxic Enforcement Act of 1986” is a law passed by voters in California in 1986. The purpose was to protect the citizens of California from toxic chemicals from the drinking water and products found in the market. This act requires the state of California to produce a list of chemicals that are known to cause various health problems such as cancer, birth defects and other reproductive harm. Proposition 65 affects every business that is found in California including all cosmetic, OTC drug and medical device manufacturers. Since being published, this list has grown and now contains over 800 chemical ingredients. It is important for businesses and manufacturers to pay close attention to Proposition 65 and the new chemicals being added.

How is it enforced?

In general, Proposition 65 is enforced by the California Attorney General’s Office and by litigation with the burden placed upon the business rather than the plaintiff. In order for companies to be on the market in California, they are required to provide a “clear and reasonable warning” on their product if a listed chemical is found on their ingredient list. This warning could be anything from a label or publishing an article in the newspaper. This warning must be present until the listed chemical has a low enough exposure to pose no significant risk to the public, deeming it “insignificant.”

The “significance” of a chemical and its exposure are determined based upon Safe Harbor Levels. These levels were defined by OEHH (Proposition 65) A and simply state that “a business has a Safe Harbor from Proposition 65 warning requirements or discharge prohibitions if exposure to a chemical occurs at or below these level” (Proposition 65). Presently, there are over 300 safe harbor levels and that number is always increasing as more chemicals become listed due to the vigorous debate over the various levels.

Proposition 65 Importance

The importance of Proposition 65 is that it has provided citizens of California with information on a way to reduce their exposure to various chemicals. This is apparent in the fact that since being passed in 1986, the state of California has noticed a much greater awareness of alcohol consumption during pregnancy and its toxic effects. The main goal of this proposition however, was to provide a greater incentive for manufacturers to remove the listed ingredients from their products if possible. The fact that a Proposition 65 warning must go on their label can motivate manufacturers to remove chemicals from their products.

Product manufacturers entering the Californian market must pay close attention to the different regulations and potential Proposition 65 exposure in order to be successful in this growing industry along with maintaining a strong consumer loyalty. Focal Point Research Inc. has been involved with Regulatory Affairs and Consulting within Canada and the United States for over 20 years; therefore we offer an immense knowledge and unique advantage in Proposition 65 consulting.