California Prop 65: Maximum Allowable Dose Level of 8,700 micrograms per day (Oral and Ingested) for Ethylene Glycol

On April 4, 2017, California’s Office of Administrative Law approved a Maximum Allowable Dose Level (MADL) for ethylene glycol (ingested) of 8,700 (oral) micrograms per day, which is the same MADL proposed by the California Environmental Protection Agency's (Cal/EPA) Office of Environmental Health Hazard Assessment (OEHHA) for the chemical formerly. Ethylene Glycol—a substance used in the production of several packaging materials—was added to the list of chemicals known to the State of California to cause reproductive toxicity under Prop. 65 on June 19, 2015. Proposition 65, or the Safe Drinking Water and Toxic Enforcement Act of 1986, prohibits a company from knowingly exposing any individual to a listed chemical without first providing a "clear and reasonable warning" to such individual. The law provides an exemption from the need to provide a warning where exposures are below a "safe harbor"—an established no significant risk level (NSRL) for a carcinogen or an MADL for a reproductive toxicant. The MADL for ethylene glycol will be added to Title 27, California Code of Regulations, section 25805, and will become effective on July 1, 2017. Background information can be found on OEHHA’s Prop 65 website at https://oehha.ca.gov/proposition-65/notices. Ethylene glycol in product is also restricted under 16 CFR 1500.14, Products requiring special labeling under section 3(b) of the FHSA and LHAMA.

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