
California's Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, requires suppliers and distributors to warn consumers about the risks associated with exposure to several plasticizers or softeners added to certain soft plastics. Proposition 65 applies to all products sold within California, including consumer goods, commercial goods, and construction materials like piping systems. It mandates clear and reasonable warnings for products containing chemicals known to the state of California to cause cancer or reproductive harm. To comply with Proposition 65, plastic distributors must ensure their products are properly labelled, provide written notices to retailers, and include specific identifying information about the product. Distributors should also be aware of potential listing changes, such as the addition of commonly used phthalates, to ensure they can adapt to evolving regulatory requirements.
| Characteristics | Values |
|---|---|
| Full Name | Safe Drinking Water and Toxic Enforcement Act of 1986 |
| Year | 1986 |
| Enforced By | California Office of Environmental Health Hazard Assessment (OEHHA) |
| List of Substances | More than 900 substances known to cause cancer or reproductive toxicity |
| Examples of Substances | Carbon black, formaldehyde, vinyl chloride, lead, phthalates, tobacco smoke, ethyl alcohol |
| Scope | All products sold in California, including consumer goods, commercial goods, and construction materials |
| Warning Requirements | Clear and reasonable warnings required on product labels or at the point of sale |
| Safe Harbor | Scientific evidence of compliance with safe harbor provisions can exempt companies from warning requirements |
| Automotive Suppliers | Required to warn consumers about risks associated with exposure to certain soft plastics |
| Plastic Distributors | Required to provide warnings for products containing trace amounts of listed chemicals |
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What You'll Learn

Proposition 65 labelling requirements
California Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act, was enacted in 1986. This proposition applies to all products sold within California, including consumer goods, commercial goods, and construction materials like piping systems. It requires businesses to provide clear and reasonable warning labels on products that contain chemicals known to cause cancer, birth defects, or other reproductive harm.
The warning labels must be prominently displayed, with the word "WARNING" in bold capital letters, along with a black exclamation point surrounded by a yellow triangle. The font size for the warning label must be at least 6 points and cannot be smaller than the largest font size used for other consumer product information. The entire name of the listed chemical must appear in the warning at least once. For online sales, a warning must be shown on each product-specific web page before the consumer completes the purchase. If a warning is provided in a language other than English, it must also be offered in English.
Warnings are required if anticipated exposure exceeds the safe harbor limit. In some cases, a Safe Harbor warning format can be used as a defence to an allegation that consumer warnings should have been provided. However, the mere presence of a listed compound in a product does not trigger the need for a warning label. For example, if a product is sold loose without a label, the manufacturer can provide a written notice to the retailer stating that a Proposition 65 warning is required and provide all the necessary warning materials.
Proposition 65's main objective is to safeguard California's drinking water sources from contamination by these harmful chemicals. Businesses must report any releases of the listed chemicals into drinking water sources and take action to stop or minimize their release.
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Warnings for consumer products
California Proposition 65, often referred to as Prop 65, is a California law that requires businesses with ten or more employees to provide warnings when their products contain chemicals known to the state of California to cause cancer, birth defects, or other reproductive harm. It is officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986.
Prop 65 applies to all products sold within California, including consumer goods, commercial goods, and construction materials like piping systems. It is important to note that the presence of a listed compound in a product does not automatically trigger the need for a warning label. Warnings are required if anticipated exposure exceeds the safe harbour limit.
For consumer products, if a product contains a listed chemical and poses a significant risk of exposure, the manufacturer must either remove the chemical or provide a warning label on the product, product packaging, or other product-associated materials. The warning label should be clear, concise, and contain specific information about the health risks posed by exposure to the chemical. It must be prominently displayed and easily visible, complying with size requirements, to ensure that it is likely to be seen, read, and understood by a consumer under customary conditions of purchase or use.
If a product is sold online, a consumer product warning must be shown on each product-specific web page. The warning should state that the product "can expose you to" a listed chemical, rather than saying the product "contains" the chemical. By providing clear and reasonable warnings, suppliers and distributors of products can ensure compliance with Proposition 65 and avoid potential legal consequences.
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Workplace exposure warnings
California Proposition 65, often referred to as "Prop 65", is a California law that requires businesses to warn consumers about potential exposure to chemicals that may cause cancer, birth defects, or reproductive harm. This allows consumers to make informed decisions about the products they purchase and use. The law also applies to potential chemical exposure in the workplace and aims to protect the state's drinking water sources from toxic chemical contamination.
Prop 65 requires manufacturers to affix warning labels to products containing certain dangerous chemicals. These labels must be clear and reasonable, providing specific identifying information about the product, such as its name, description, or UPC. If a product is sold online, a consumer warning must be displayed on each product-specific webpage.
For plastic distributors, Prop 65 imposes a duty to warn consumers about the risks associated with exposure to plasticizers or softeners added to certain soft plastics. These soft plastics are commonly used in automotive products, such as vinyl seat covers, steering wheel covers, and plastic hoses. The presence of a listed compound in a product does not always trigger the need for a warning label. Warnings are required if the anticipated exposure exceeds the safe harbor limit.
To comply with Prop 65, businesses with ten or more employees must ensure that their products are properly labelled. Third-party Proposition 65 testing can assess whether products contain any listed chemicals and if the levels necessitate a warning label. If a product contains a listed chemical and poses a significant risk of exposure, the manufacturer must either remove the chemical or provide a warning label on the product, packaging, or associated materials.
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Environmental exposure warnings
California Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, is a law that requires businesses to warn Californians about certain chemicals in the environment and/or consumer goods. Proposition 65 was designed to address the growing concerns of California residents about exposure to toxic chemicals and help them make informed decisions about the products they purchase and their potential health impact.
The Office of Environmental Health Hazard Assessment (OEHHA) maintains a list of more than 900 substances known to the state to cause cancer or reproductive toxicity. The list includes naturally occurring and synthetic chemicals that are additives or ingredients in pesticides, common household products, food, drugs, dyes, or solvents. Listed chemicals may also be used in manufacturing and construction or may be byproducts of chemical processes, such as motor vehicle exhaust.
Proposition 65 requires clear and reasonable warnings on products that may expose consumers to any of the listed substances. Warnings are required if anticipated exposure exceeds safe harbour limits. Safe harbour warnings are defined in the Proposition 65 regulations, and scientific evidence of compliance with these provisions is a complete defence against allegations that consumer warnings should have been provided.
For some products, California requires the label or packaging to carry a clear and reasonable warning. In other cases, placards at the point of sale with the appropriate warning text are considered sufficient. If a product is sold online, a consumer product warning must be shown on each product-specific web page.
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Safe harbour provisions
California's Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, requires businesses to warn customers when their products contain chemicals known to cause health problems. Proposition 65 applies to all products sold within California, including consumer goods, commercial goods, and construction materials. It also applies to companies with 10 or more employees selling products to consumers in California, including online sales.
Under Proposition 65, the California Office of Environmental Health Hazard Assessment (OEHHA) maintains a list of over 900 substances known to cause cancer or reproductive toxicity. These substances include phthalates, a group of chemicals commonly used to make plastics more durable. Warnings are required if anticipated exposure exceeds the safe harbour limit. The OEHHA has published regulations defining the "safe harbour" warning format, which is considered clear and reasonable.
The "safe harbour" provisions in the statute provide a defence against allegations that consumer warnings should have been provided. To take advantage of these provisions, companies can follow these four steps:
- Determine the applicable Safe Harbour level: Either the No Significant Risk Level (NSRL) for carcinogens or the Maximum Allowable Dose Level (MADL) for developmental and reproductive toxicants.
- If OEHHA has not established an NSRL or MADL, hire a recognised toxicologist to derive an NSRL based on a review of the scientific literature related to exposure to that substance.
- It is important to note that a Safe Harbour level does not equate to the concentration of a substance in a product component but to the maximum amount that the human body can be exposed to daily.
- Keep a file of reports and calculations in the legal department to rebut any Notice of Violation received.
By planning to meet the requirements of the Proposition 65 "safe harbour" provisions, companies can avoid warning label requirements and litigation for labelling violations.
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Frequently asked questions
California Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, is a law that requires companies to provide a clear and reasonable warning to consumers when products expose them to substances known to the state of California to cause cancer or reproductive toxicity.
Proposition 65 applies to all products sold in California, including plastics. Distributors must provide clear and reasonable warnings for products that may expose consumers to any of the listed substances. Warnings are required if anticipated exposure exceeds the safe harbor limit.
The California Office of Environmental Health Hazard Assessment (OEHHA) maintains a list of over 900 substances known to cause cancer or reproductive harm. Examples include lead, phthalates, formaldehyde, and tobacco smoke.

































