In 2016, California’s Office of Environmental Health Hazard Assessment (OEHHA) published their notice of intent to list perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) to the state’s Proposition 65. While the two chemicals had been listed on Proposition 65 in November 10, 2017, implementation will be effective November 10, 2018.
PFOA and PFOS are synthetic compounds that do not occur naturally in the environment and are fully fluorinated. PFOA and PFOS are not ingredients intended for cosmetic products, however they are identified in some cosmetics and sunscreens as contaminants of polytetrafluoroethylene (PTFE) – a known cosmetic ingredient.
The State of California had identified and produced sufficient information that the chemicals cause reproductive toxicity to the human body. This was determined from clinical studies on rats and mice as well as epidemiological data from general human populations. In addition, PFOA and PFOS have been found to be persistent in the environment where they have been shown to be toxic for use and consumption. Moreover, the U.S. state of Michigan had recently declared a state of emergency due to alarming levels of PFOA and PFOS found in local drinking water – linking the compounds to serious health issues.
In the past, PFOA and PFOS were widely used in industrial application for their oil- and water-resistant properties in addition to their use in certain waterproof sunscreens. However, after concerns by the U.S. Environmental Protection Agency (EPA), their production and use had begun to decline. Regardless, the Independent Cosmetic Manufacturers and Distributors (ICMAD) has cautioned the cosmetics and personal care products industry as these compounds could make manufacturers vulnerable to lawsuits. ICMAD suggests that companies that are manufacturing, distributing or selling products in California to determine if their products contains PFOA and/or PFOS and to prepare a warning label accordingly if present. It should be noted that the OEHHA has not set permissible use levels for these two chemicals yet.
For more information, please do not hesitate to contact Focal Point Research Inc. We are leading U.S. regulatory and FDA consultants for Cosmetics, and other personal care products.