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What is Prop 65?
California Proposition 65 was initiated to protect
the residents of the State of California from products and
environmental contaminants known to cause cancer, birth defects, or
other reproductive harm. A full legal description of the measure can
be found at the
California Office of Environmental Health Hazard Assessment
What does it mean?
With the exception of small business (less than ten employees) the enactment of Proposition 65 requires all manufacturers and/or distributors to investigate the health impacts of their products on the consumers. The number of compounds that are carcinogenic in nature, or may cause birth defect or other reproductive harm, are almost limitless which would apply an insurmountable burden for any product sales. The state of California releases an updated list of chemicals of concern on an annual basis. This list should be reviewed by any affected party on an annual basis to monitor changes in regulatory requirements.
What you need to know?
Before panicking and sending your product to be tested for all chemical of interest, an in-house breakdown of the product components and manufacturing processes should be created. The generation of this list greatly facilitates the identification of what specific components may need testing. When identifying the necessity of testing for any materials, keep in mind that the regulations are based on maximum allowable dose levels for standard daily exposure. Grinding up the product and testing the homogenate does not necessarily represent the standard daily exposure concentration, rather the total concentration of the chemicals within the product. While a product may contain identified carcinogens of interest, they may be encapsulated which ultimately eliminates the exposure to the consumer. Identifying the applicability, chemicals of interest, and exposure pathway before having your product tested can result in significant savings associated with testing services.
In addition, the manufacturer of the different components may have helpful information which may also negate the necessity to have your product tested. Specifically, if your product contains paint, the paint manufacturer may already have tested the paint for lead. Before shipping anything out to the laboratory, it is always recommended to gather as much information about your product as possible.
Always keep in mind the specifics of the regulation. The list of chemical of concern are very specific, often requiring specialty analytical testing. Arsenic, for example, is not regulated as a carcinogen. Inorganic arsenic, however, is defined as a carcinogen and must be accounted for. With this in mind, if the analysis of a food supplement results in elevated arsenic concentrations, further investigation may identify that the arsenic compounds are organic in nature and do not require any action or special labeling.
How can we help?
Applied Speciation and Consulting can provide you with consultation and analytical testing services to ensure compliance with California Proposition 65. Testing services provided by Applied Speciation specialize in inorganic testing and specific compound identification.
For consultation regarding the interpretation of the law we typically refer to trained legal professionals.
Feel free to contact a representative at Applied
Speciation to identify how we can assist you to ensure your products
are in compliance with California Proposition 65. (206) 219-3779 or
email
info@appliedspeciation.com.