California Proposition 65 for Article Manufacturers
Proposition 65 was a ballot initiative passed by the voters of California in 1986. The law is called the Safe Drinking Water and Toxic Enforcement Act of 1986. Particularly important to product manufacturers is Article 6, "Clear and Reasonable Warnings".
While the effect is far broader, the bottom line for the product manufacturer is that, if a product can expose a user to any of over 900 (and growing) chemicals, the manufacturer must provide a warning on the product or its immediate packaging.
Whether notification is actually required, and how that notification is to be provided, varies according to where the manufacturer is located, how and where it is being sold, and the type of customer.
One aspect that makes this regulation so challenging for manufacturers is that, unlike the vast majority of other substance-related disclosure (and restriction) regulations, it is not based on substance concentration; it is based on exposure. While often related to concentration, other factors - including the material the substance is part of and how the product is used - affect the availability of the substance to expose the user. Ultimately, in order to determine whether a substance exceeds the exposure limits provided by the State of California ("No Significant Risk Levels", or NSRLs, or "Maxiumum Allowable Dose Levels", or MADLs), a test and evaluation defined and interpreted by a toxicologist is usually required. Manufacturers can engage a toxicologist to determine whether a label is necessary for any given situation, or simply go ahead and label their product; there is no defined procedure to make the decision. We help manufacturers understand how and when to make these decisions.
While the regulatory language focuses on consumer products, occupational product use is also in scope.
Read our recent article on the topic.
What can DCA Do for You?
Understanding and implementing a compliance program around Proposition 65 can be a relatively complex endeavor for a manufacturer. DCA works, as needed, with toxicologists and specialist lawyers to help you understand and implement an efficient approach to compliance with the regulation that integrates with your existing product lifecycle process and compliance program.
Please contact us for more information.