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Parabens, Carcinogens and Certified Organic Ingredients

By: Rebecca James Gadberry
Posted: June 25, 2008, from the January 2006 issue of Skin Inc. magazine.

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Although the list of toxicant ingredients has not been finalized as of press time, insiders believe that the act will recognize the more than 750 substances that are identified in the state’s Proposition 65 regulation—officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986. This list can be viewed at

Although Proposition 65 requires a manufacturer to post consumer warnings when a product contains harmful levels of one or more of the identified substances known by the state to cause cancer, birth defects or other reproductive harm at the point of sale, the California Safe Cosmetics Act of 2005 goes further by requiring companies to inform the state if a product contains any level of the substance.

Rationale for the new legislation is based on the concept that individuals can use multiple products containing carcinogens or fetal toxicants, thereby causing levels of exposure to exceed safe limits that are not taken into account with Proposition 65. What is not considered is that the allowable levels noted in Proposition 65—no significant risk levels (NSRLs) for carcinogens and maximum allowable dose levels (MADLs) for fetal toxicants—are based on maximized exposures that are known as “safe harbor levels.”

The safe harbor NSRL for carcinogens is calculated to result in one excess case of cancer in an exposed population of 100,000, assuming each person is exposed to the level in question for 70 years. The safe harbor MADL is the level at which the chemical in question would have no observable adverse reproductive effect at 1,000 times the level of allowed exposure.

To put this into perspective, let us examine one of the ingredients that most likely will be added to the Proposition 65 list next year—dibutylphthalate. This is a substance that is mixed into nail polish to help it spread more easily. Banned in the European Union due to its effects on animal fetuses, it has a margin of safety that is 36,000 times the amount usually usedin nail polish. In other words, you could eat15 bottles of nail polish a day for seven years and still not get the effect noted in animal tests.