California Proposition 65 Compliance – Warning Requirements & Restricted Substances List FAQ

Understanding California Proposition 65 compliance is essential for any business selling products in California. This regulation — also known as the Safe Drinking Water and Toxic Enforcement Act — outlines Prop 65 warning requirements and maintains a frequently updated restricted substances list covering over 900 chemicals. Whether you manufacture, import, or retail consumer goods, knowing which chemicals are present in your products, your safe harbor exposure levels, and how to label correctly can help you avoid costly lawsuits and protect your brand. Our FAQs below answer the most common questions to help you stay compliant and informed.

CALIFORNIA PropOSITION 65 - FAQ VIDEO

What is California Proposition 65?

California Proposition 65 or Cal Prop 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, is a law that requires businesses to provide a clear and reasonable warning before knowingly and intentionally exposing anyone to chemicals known to cause cancer, birth defects, or other reproductive harm. The California Office of Environmental Health Hazard Assessment (OEHHA) is responsible for enforcing this law by creating and maintaining a list of restricted substances. They also help to identify what products contain these substances and require warning labels on them.

The Proposition 65 list is due to update each year, and currently, the list has grown to more than 900+ chemicals, and the listed chemicals are used in consumer products manufacturing, or as a by-product of the chemical processes. As you know, Cal Prop 65 does not explicitly restrict the sales of products that contain the listed chemicals. However, it does require businesses to provide a “clear and reasonable” warning if a product’s content of any listed chemicals exceeds the established “safe harbor levels”.

Who Needs to Comply With Prop 65?

Prop 65 compliance is mandatory for any business (with 10 or more employees) selling consumer products in California—even if the company is outside the state. The regulation covers a wide range of goods, including packaging, toys, household items, jewelry, electronics, textiles, and more.

What is “Safe Harbor Levels”?

While acceptable Levels of exposure in the product do not require a Prop 65 warning. For carcinogens, the safe harbor levels are called No Significant Risk Levels (NSRL).  And, for reproductive toxins, the safe harbor levels are called Maximum Acceptable Dose Levels (MADL).

The safe harbor levels have not been established for all Prop 65 listed chemicals. For carcinogens, there are over 600 chemicals are listed, but only approximately 300 of those have established NSRL. And for reproductive toxins, there are over 300 chemicals are listed, but only about 45 of those have established MADL.

What are the Costs and Risks of non-compliance with Prop 65?

Failure to non-compliance with Prop 65, not only can lead to a high cost of legal actions, but also it can cost massive product recalls and damage your brand's reputation. 

While OEHHA lists chemicals and identifies exposure levels, but does not enforce the act itself. The enforcement is determined by the lawsuits, and the California Attorney General’s office or District Attorneys (D.A.) can file enforcement action without notice. Any private individual may sue if no prosecutor takes the case within 60-day of notice of violation.

Last year, the total settlement payments are US$20,575,208. Individual settlement payments range from US$6,000 to over US$425,000 and the average cost per settlement including attorney fees was US$31,605.

There are lawsuits have been brought against manufacturers and retailers of a wide variety of consumer products including:

Does California Proposition 65 apply to all products?

Yes, the law is about exposing the consumer to harmful chemicals. Any product that contains one of the listed chemicals can be a source of exposure to the consumer. In recent activity, some types of packaging also have been applied. 

While all consumer goods are considered under this law, there are some product categories that are considered high risks of being targeted but not limited to such as:

· Toys and children’s products
· Household Items
· Jewelry
· Personal accessories

What is the Prop 65 restricted substances list, and how often does it change?

The Prop 65 restricted substances list is maintained by California’s Office of Environmental Health Hazard Assessment (OEHHA) and includes more than 900 chemicals known to cause cancer, birth defects, or reproductive harm. The list covers substances commonly used in manufacturing and consumer products, as well as byproducts from chemical processes.

Examples include:

· Lead and lead compounds (found in metal parts, paints, ceramics)
· Cadmium (sometimes used in batteries, pigments, or coatings)
· Phthalates such as DEHP and DBP (found in certain plastics and vinyl)
· Formaldehyde (in textiles, wood products, or adhesives)
· Acrylamide (can occur in some food and packaging materials)

The list is updated at least once a year, and new chemicals may be added as scientific research and regulatory decisions evolve. Businesses must routinely monitor updates to ensure their products remain compliant and correctly labeled according to the latest list.

What if my products contains an amount of a listed chemical that meets other regulatory limits such as CPSIA, REACH, etc.?

Even if the content of your products meets other regulatory limits under CPSIA or REACH, it does not automatically meet the requirements of Proposition 65 and it may still need a label, depending on exposure risk.

What you need to do in order TO comply with CA Prop 65?

There are steps you’ll need to take to comply the Prop 65 law:

 •  Test for specific products to prior Prop 65 product litigation, or;
 •  Require a certified toxicologist review the product to determine if an exposure exceeding safe harbor limits exists, or;
​​​​​​​ •  Label the appropriate Prop 65 warning statement

BV offers comprehensive services designed to help you meet the compliance of Prop 65 and are available for a wide range of consumer products: 

 •  Analytical Testing Services: Identifies levels of listed Prop 65 substances in a product and test to current consent decrees
 •  Design Evaluations: Reviews product construction and/or formulations with possible recommendations
 •  Technical Opinion Letters: Evaluates your formulation against the current list of Prop 65 chemicals

Our approach:

 •  By monitoring Proposition 65 actions and settlements, we help retailers and manufacturers take a proactive and comprehensive approach to compliance.  
 •  We assist our clients in determining if listed Prop 65 chemicals are present in their products, identifying exposure routes, and assessing the risk levels in items.  
 •  We then help our clients to build in the appropriate requirements into their testing and quality assurance program on an ongoing basis.