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California Proposition 65

California Proposition 65 requires companies selling products in California to comply with its warning requirements. Violations related to Prop 65 warnings may expose your business to lawsuits. Accordingly, the most cost-effective approach is to take proactive steps to address compliance with this law.

California Proposition 65

What is the California Proposition 65?

Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, is a California law that requires businesses to provide warnings to Californians about significant exposures to chemicals that cause cancer, birth defects, or other reproductive harm. The California Proposition 65 list is updated every year. Therefore, it is crucial to remain informed on the latest added Prop.65 substances such as 1-Bromo-3-Chloropropane, Butyl Glycidyl Ether, and Glycidyl Methacrylate.

Who Administers California Proposition 65?

CalEPA
OEHHA Prop 65

The Office of Environmental Health Hazard Assessment (OEHHA), part of the California Environmental Protection Agency (CalEPA), administers the Prop 65 regulation. With this intention, OEHHA keeps a list of recognized carcinogens and reproductive toxins. The agency updates the list at least once a year by adding new chemicals. The list contains more than 900 substances, according to the update of February 25, 2022. Notably, once the agency adds a new chemical to the list, it takes 12 months before the P65Warnings requirements apply.

Why is there a California Proposition 65 Regulation?

Hazardous chemicals, known to contribute to cancer, birth defects, or reproductive harm, are used in many everyday consumer products.  Think of adhesives, painting, solvent, some plastics, some drugs… even coffee!  All of these products may contain hazardous substances.

Here are some examples of substances in the Prop 65 list:

Prop 65 Chemical NameWhere Used Examples
Bisphenol A (BPA)Polycarbonate plastics, epoxy products, Thermal papers
Bromacil lithium saltHerbicide
Butyl benzyl phthalate (BBP)BBP is also a Europe RoHS substance, found in PVC, adhesives, paints, inks, lacquers
Carbon-blackRubbers, inks, paints
Chlorinated paraffins (Average chain length, C12; approximately 60 percent chlorine by weight)Lubricant additives, flame retardant in plastics, rubbers, and paints
Cobalt metal powderBatteries, pigments
Coconut oil diethanolamine condensate (cocamide diethanolamine)Bath Products
Formaldehyde (gas)Fungicide, melamine resins
NickelElectroplating, pigment, batteries, magnets
Perfluorooctanoic acid (PFOA)Teflon, fire-fighting foams, adhesives
PyridinePesticide
Tetrabromobisphenol AReactive flame retardants, in plastics, adhesives, coatings
Wood dustSawmills
ZileutonMedication
 

Many Prop 65 substances are used in electrical and electronic equipment and other everyday products. Compounds of cadmium, cobalt, mercury, nickel, lead or hexavalent chromium are examples of these types of substances.

Which industries are Most at Risk?

According to an analysis of the 60-day notices for violation of California P65Warnings obligations in 2020, consumer products from the following industries are at the highest risk of legal actions:

  • Plastics
  • Ceramics
  • Metals
  • Food
  • Leather
  • Dietary supplements, etc.

How to Make Sure that you Comply with California Proposition 65?

To comply with the Proposition 65, you must follow these steps:

California Proposition 65 testing

1. Determine the scope

This regulation applies to products sold, imported, or distributed in the state of California.

2. Due your due diligence

2. Due your due diligence
Determine if your products contain any of the chemicals listed under Prop. 65

  1. Conduct audits on your supply chain.
  2. Assess your potential risks.
  3. Confirm compliance from upstream suppliers.
  4. Investigate the prop.65 status of similar products subject to Notices of Violations.
  5. Prepare compliance plans.

3. Assess whether your product is Business to Business (B2B) or Business to Consumer (B2C)

  1. B2B products require a declaration list of contained prop.65 substances.
  2. B2C products require exposure warning labels.

Interestingly, there are three types of exposures that require a warning:

  • The consumer product exposure
  • The environmental exposure
  • The occupational exposure.

4. Evaluate the exposure levels

If your consumer products contain listed chemicals, you need to evaluate the level of exposure to determine if it is significant enough to trigger the warning requirement.

5. Provide a California Proposition 65 Warning

If the exposure is significant, you must provide a clear and reasonable warning to California consumers. This so-called safe harbor warning can be given on:

  1. the product label.
  2. on a sign at the point of sale
  3. through a general warning on a product website.
California Prop. 65 standard form warning notice
Example of Safe Harbor Warning - Prop 65

If any substance in the Prop 65 list is contained, or likely to be present in your products, workplace, and or a public area, such as a hotel, then a specific warning is requested.

Different warning methods are available, like:

  • On a posted sign on a shelf, at a hotel main entrance, etc.
  • A pop-up before placing an online product order
  • A label on the product itself.

The Prop 65 warning can take various forms depending on the risks of exposure caused by the substances present in a product, which are either:

  • Carcinogens;
  • Reproductive toxicants, or reprotoxic;
  • both carcinogens and reproductive toxicants.

Prop65 Short-form Warning Label: A short-form warning label is possible under the following conditions:

  • The mention of CA WARNING or CALIFORNIA WARNING
  • The identification of at least one chemical under the Prop65 list
  • In no case shall the warning appear in a type size smaller than 6-point type

This rule applies from January 1st, 2025, with a grace period of 3 years until January 1st, 2028, per the approved amendment of Article 6 to Chapter 1 of Division 4 of Title 27 of the California Code of Regulations.

CA Prop65 Short-form
Example of Proposition 65 short-form warning

6. Keep proper documentation

You must maintain records that demonstrate your compliance with Prop. 65, including:

  1. Documentation such as datasheets, SDS, certificates of conformity, drawing sheets, testing reports, full material declarations (FMDs), etc.
  2. Any chemical testing performed to determine the presence of the listed prop.65 substances.
  3. Exposure evaluations

How to Protect your Business from Prop 65 Warnings Penalties?

Companies can implement several approaches to avoid penalties related to Prop 65 violations, such as:

  • Conduct product testing and audits
  • Provide pre-emptive warnings
  • Obtain confirmation of conformity from upstream suppliers
  • Prepare compliance plans
  • Investigate whether similar products have been the subject of Notices of Violations
  • Pay special attention to substances that are frequently the subject of Notices of Violations
  • Maintain records properly
  • Communicate with employees about any changes in standards or compliance strategies

It is recommended to verify with your supply chain whether any chemical in the Prop 65 list is present in your product, especially for parts that can be in direct contact with the consumer under normal conditions of use, such as:

  • buttons
  • cables
  • casings
  • labels
  • connectors
  • screens
  • batteries
  • packaging items, etc.

A risk assessment can be necessary, to confirm the substance(s) on the Prop 65 list that may have to be declared.

What if I don't Comply with Prop 65?

If you sell a product without a safe harbor warning that does contain a chemical in the Prop 65 list, then you expose your company to lawsuits.

Some law firms are specialized in this type of lawsuit, and major distributors, such as Amazon, Costco, Pharmacy, Target, and Walmart have had to face legal proceedings.

As a result, the Prop 65 settlement payments go up over the years, to reach a total of tens of millions of dollars. 

The image of non-compliant companies can also be severely damaged.

Other requirements may specifically apply to your products, like California RoHS for electrical and electronic household equipment.

California Prop 65 FAQ

Is there a “Prop 65 certification”?

Not really. Prop 65 is a warning/exposure law (and a drinking-water discharge law), not a government-issued “certification” program. Compliance is usually demonstrated through supply-chain documentation and/or exposure assessment, and—when needed—testing and toxicology support.

Prop 65 generally applies to businesses with 10+ employees doing business in California. It can still affect out-of-state companies if their products are sold into California (including online sales).

Prop 65 warnings are triggered by significant exposures, not simply “a chemical exists somewhere in the product.” If exposures are below “safe harbor” levels (when available), a warning may not be required.

OEHHA publishes “safe harbor” levels for many chemicals: NSRLs (cancer) and MADLs (reproductive toxicity). If a chemical has no safe harbor level, companies typically need a defensible approach to evaluate exposure and risk (often involving toxicology expertise).

Penalties can be as high as $2,500 per violation per day, and Prop 65 is commonly enforced through private actions in addition to public enforcement. Many cases start with a 60-day notice process.

Short-form warnings exist, but California has moved to make them more informative (including requiring at least one chemical name under certain updated rules and timelines). Make sure your label strategy matches the latest OEHHA “clear and reasonable warning” requirements.

The Enviropass Approach on California Proposition 65

This approach offers the best money value and avoids numerous and expensive chemical analyses.  

Enviropass can assist you in both:

  • identifying the presence of substances in your products; and
  • marking your products accordingly.
Proposition 65 Prop 65

Prop65 Consulting & Documentary Review

You may have test reports and certificates. Are they applicable to the materials in direct contact with the final users or installers? 

Prop65 Testing Lab

Our lab network can help you test your parts against the most at-risk California Proposition Substances.