Is your consumer product in compliance with California Proposition 65?
Failure to be in compliance can lead to law suits, heavy penalties and court-mandated reformulation.
16 September 2014
California's Safe Drinking Water and Toxic Enforcement Act of 1986, known generally as Proposition 65 and is intended to provide consumers with information about potential exposures to carcinogens and reproductive/developmental toxicants. This law can require a manufacturer to provide a "clear and reasonable warning" on their products if they contain a listed carcinogen or reproductive or developmental toxicant. Proposition 65 is self-contained and EPA, FDA or REACH registrations do not confer exemption from the law.
Since 1986, over 800 chemicals have been placed on the Proposition 65 list by the California Office of Environmental Health Hazard Assessment (OEHHA). The list contains chemicals, additives and other ingredients present in many common household and office products including toys, clothing, shoes, jewelry, pesticides, rugs, furniture, appliances, luggage, medical devices, over-the-counter drugs and food. A product manufacturer is required to determine to the best of their ability whether their products contain a listed substance. If the listed substance is present, the manufacturer must provide a label statement warning consumers of the potential hazard or demonstrate that human exposures related the product are below "safe harbor levels" established by the state. Unfortunately, OEHHA has set safe harbor levels for less than 1/3 of the listed chemicals and, where safe harbors levels have not been established, manufacturers must either provide warnings regardless of the degree of risk or establish a safe harbor level, an often difficult task even for companies with experienced toxicologists.
California's Proposition 65 can be a challenging task for all companies and Intertek's experience and technical expertise is an invaluable resource to ensure your compliance issues are managed efficiently and fairly.
Do you have questions regarding Prop 65? Please leave your comments below and one of our experts will get back to you.
Today’s expert blogger is Ms. Angelique Danek, Director of Business development for Intertek’s Health, Environmental, and Regulatory Services Group in the US. The essence of her team is to assist clients with entering new markets, introducing new products, and complying with existing regulations.