California Proposition 65 Warning and List - FAQ
Our exhaustive FAQ and guide on California Proposition 65 and how to comply by the law for your company.
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WHAT IS CALIFORNIA PROPOSITION 65?
The Safe Drinking Water and Toxic Enforcement Act of 1986, also known as California Proposition 65 or Ca Prop 65, is a law that mandates businesses to give a clear and reasonable warning before purposefully and knowingly exposing anyone to chemicals that are known to cause cancer, birth defects, or other reproductive harm. This rule is enforced by the California Office of Environmental Health Hazard Assessment (OEHHA), which compiles and updates a list of prohibited compounds. They also make it easier to determine which goods need to have warning labels attached because they contain these compounds.
The Proposition 65 list must be updated annually, and it already includes more than 900 compounds that are either utilized in the production of consumer goods or are byproducts of chemical operations. As you are aware, California Proposition 65 does not specifically prohibit the sale of goods that include the substances listed. It does, however, mandate that companies issue a "clear and reasonable" notice if a product's concentration of any listed substances is higher than the predetermined "safe harbor levels".
WHAT IS “SAFE HARBOR LEVELS”?
Although permissible Exposure Levels exist in the Product, a Prop 65 warning is not necessary. The safe harbor concentrations for carcinogens are known as No Significant Risk Levels (NSRL). Maximum Acceptable Dose thresholds (MADL) are the safe harbor thresholds for reproductive poisons.
Not all of the substances listed under Prop 65 have had their safe harbor limits established. Only about 300 of the over 600 compounds that are designated as carcinogenic have established NSRLs. And while there are over 300 compounds classified for reproductive toxicity, only roughly 45 of them have documented MADLs.
WHAT ARE THE COSTS AND RISKS OF NON-COMPLIANCE WITH PROP 65?
Failure to comply with Prop 65 can result in expensive legal actions as well as costly product recalls and reputational damage for your company.
Although it includes substances and specifies exposure levels, the OEHHA does not really enforce the legislation. The District Attorneys (D.A.) or Attorney General's office of California may file enforcement action without prior notice. The enforcement is governed by the litigation. If a prosecutor declines the case within 60 days of receiving a notice of violation, any private person may file a lawsuit.
The entire settlement amounts made last year came to $20,575,208 USD. The average settlement cost, including legal fees, was US$31,605 while individual settlement payments ranged from US$6,000 to over US$425,000.
Lawsuits against manufacturers and retailers of a wide variety of consumer products are including:
| alcoholic beverages | antacids | brass keys/hose nozzles |
| ceramic tableware | crystalware | correction fluid |
| dental fillings | exterior decorated glassware | galvanized pipe |
| jewelry | lead fishing tackle | nail polish |
| PVC computer peripherals | PVC electrical tape | PVC light strings |
| PVC lunch boxes | paint | textiles |
DOES CALIFORNIA PROPOSITION 65 APPLY TO ALL PRODUCTS?
Yes, the law concerns the exposure of consumers to dangerous chemicals. Any item with one of the specified chemicals in it puts the customer at risk of exposure. Some packing types have also been utilized recently.
Although this rule applies to all consumer goods, there are several product categories that are seen to carry a higher risk of being targeted, including but not limited to:
· Toys and children’s products
· Household Items
· Jewelry
· Personal accessories
WHAT IF MY PRODUCTS CONTAINS AN AMOUNT OF A LISTED CHEMICAL THAT MEETS OTHER REGULATORY LIMITS SUCH AS CPSIA, REACH, ETC.?
The criteria of Proposition 65 are not automatically met by your products, even if the content complies with other regulatory restrictions set forth by CPSIA or REACH. Depending on the danger of exposure, your products may still require a label.
HOW TO COMPLY WITH CA PROP 65?
You'll need to take the following actions to comply with the Prop 65 law:
• Label the Prop 65 warning message as necessary.
• To assess whether an exposure that exceeds safe harbor limitations exists, either require a certified toxicologist to review the product
• Test specific products for which there have been prior Prop 65 product litigation.
HOW CAN BV HELP?
BV provides extensive services for a variety of consumer goods that are accessible to assist you comply with Prop 65:
• Analytical Testing Services: Determines the presence of compounds specified under Proposition 65 in a product and compares results to existing consent decrees
• Design assessments: examines product formulas and/or construction with potential recommendations
• Technical Opinion Letters: Assesses your formulation in comparison to the current list of Prop 65 compounds
OUR APPROACH
• By keeping an eye on Proposition 65 lawsuits and settlements, we support manufacturers and retailers in adopting a proactive and thorough approach to compliance.
• We support our clients in identifying exposure pathways, calculating the risk levels in products, and determining whether or not designated Prop 65 substances are present in their products.
• We assist our clients in continuously incorporating the required criteria into their testing and quality assurance programs.
Contact to us now by using the contact form below, and let us discuss and help you better understand about this law.