Understanding Proposition 65 Compliance and Labeling Requirements

Canned goods with warning labels

In recent years, Prop 65 compliance has become an increasingly important consideration for companies that sell consumer products in the United States. Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act, is a California law that requires businesses to provide warnings to consumers about significant exposures to chemicals that can cause cancer, birth defects, or other reproductive harm.

Prop 65 Compliance Requirements

Proposition 65 requires businesses to provide a "clear and reasonable warning" before exposing California consumers to any chemical that the state has identified as a reproductive toxicant or a carcinogen. Businesses that fail to comply with the law can face penalties of up to $2,500 per day per violation.

Prop 65 applies to a wide range of products sold in California, including toys, jewelry, furniture, electronics, and even certain foods and beverages. The list of chemicals covered currently includes over 900 substances, and the California Office of Environmental Health Hazard Assessment (OEHHA) regularly updates the list.

Prop 65 Compliance Strategies

There are several strategies that businesses can use to comply with Prop 65 requirements and minimize the risk of costly penalties. One common approach is to work with a compliance consultant to conduct product testing and determine which chemicals require warnings.

Another strategy is to reformulate products to remove Prop 65 listed chemicals or reduce exposure levels below the safe harbor threshold. In some cases, businesses may also be able to obtain an exemption from Prop 65 warning requirements if they can demonstrate that the exposure is significantly below the safe harbor level or that the chemical does not pose a significant risk of harm.

Proposition 65 Guide: Top 10 FAQs

1. Who Enforces Proposition 65?

Proposition 65 is enforced by the California Attorney General's Office and district attorneys. Private citizens are also allowed to bring lawsuits under the law.

2. What Chemicals Are Covered by Proposition 65?

Proposition 65 currently lists over 900 chemicals, including lead, phthalates, and cadmium. The list is updated annually, and businesses are responsible for staying informed about any updates or changes to the list.

3. What Are the Requirements for Proposition 65 Warnings?

Proposition 65 warnings must be clear and reasonable, and must identify the specific chemicals that are the subject of the warning. Warnings must also be provided in a language that is easily understood by the average consumer.

When it comes to type size, the warning text must not be smaller than a 6-point type and must be the same size as the consumer information on the package.

4. What is the Safe Harbor Level Under Proposition 65?

The Safe Harbor level under Proposition 65 is the level of exposure to a listed chemical that is considered safe for human consumption or use without the need for a warning. The Safe Harbor level is established by the California Office of Environmental Health Hazard Assessment (OEHHA) and is based on the maximum level of exposure that has been shown to not pose a significant risk of cancer or reproductive harm.

If a product contains a listed chemical, but the exposure to the chemical is below the Safe Harbor level, a warning may not be required. However, businesses must be careful to ensure that the exposure level is accurately measured and calculated, and that the product is not likely to expose consumers to higher levels of the chemical under normal use conditions.

5. Do My Products Need a Prop 65 Warning Label?

A business would only need to provide Prop 65 warning labels on their products if they contain any chemicals listed. The warning can be in the form of product labels, signs, or notices, depending on the type of the product and how it is sold.

Know that the law covers any product being sold in California that contains a listed chemical, regardless where it is assembled or manufactured.

6. What Type of Label Should I Use On My Products, Short Form Or Long Form?

Under Proposition 65, businesses have the option to use either a short form or long form warning label. The short form warning can be used for consumer products that contain only one listed chemical, while the long form warning is required for products that contain more than one listed chemical.

The short form warning must include the following elements:

  • The word "WARNING" in all capital letters and bold print
  • The name of at least one chemical that is known to cause cancer or reproductive harm
  • A link to the Proposition 65 website, which provides additional information about the risks associated with the chemical

The long form warning must include the following elements:

  • The word "WARNING" in all capital letters and bold print
  • A general warning about the product's potential to cause cancer or reproductive harm
  • A list of at least one chemical that is known to cause cancer or reproductive harm
  • A link to the Proposition 65 website, which provides additional information about the risks associated with the chemical

In general, businesses are encouraged to use the long form warning label whenever possible, as it provides more detailed information to consumers about the risks associated with the product. However, the short form warning label can be used in certain situations, such as for small products or products with limited space for labeling.

7. Can I Use a Package Insert or an Instruction Manual As a Means to Provide Warning?

Under Proposition 65, businesses have the option to use a package insert or instruction manual to provide warnings about listed chemicals in their products. However, the warnings must be clear and conspicuous and must be provided prior to or at the time of purchase.

If a package insert or instruction manual is used to provide warnings, the warning must meet the same requirements as other forms of warning under P65 law, including using the word "WARNING" in all capital letters and bold print, and identifying at least one listed chemical that is known to cause cancer or reproductive harm.

It's important to note that using a package insert or instruction manual to provide warnings may not always be sufficient, as many consumers may not read these materials or may discard them after purchase. In general, it's recommended that businesses provide warnings on product labels or signs, in addition to any package inserts or instruction manuals.

8. Are There Any Exemptions to Proposition 65?

Prop 65 does provide some exemptions for certain products and industries, such as food and alcoholic beverages. However, exemptions are limited and businesses are still responsible for providing warnings if their products contain listed chemicals.

9. Can Proposition 65 Warnings Be Waived or Modified?

Proposition 65 warnings can be waived or modified in certain circumstances, such as when the exposure to the listed chemical is below the level that requires a warning or when an alternative warning method is used. However, businesses should consult with legal counsel before waiving or modifying any warnings to ensure compliance with the law.

10. Can businesses be sued under Proposition 65 for failure to warn if their products do not contain listed chemicals?

No, businesses cannot be sued under Prop 65 for failure to warn if their products do not contain listed chemicals. However, businesses must be able to demonstrate that their products do not contain listed chemicals to avoid any issues.

Prop 65 compliance is a critical consideration for businesses that sell consumer products in California. By understanding the requirements for labeling and providing warnings for listed chemicals, businesses can reduce the risk of costly penalties and ensure that their products remain in compliance with California law.


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Herbert Post

Born in the Philadelphia area and raised in Houston by a family who was predominately employed in heavy manufacturing. Herb took a liking to factory processes and later safety compliance where he has spent the last 13 years facilitating best practices and teaching updated regulations. He is married with two children and a St Bernard named Jose. Herb is a self-described compliance geek. When he isn’t studying safety reports and regulatory interpretations he enjoys racquetball and watching his favorite football team, the Dallas Cowboys.