Overview

Proposition 65 (formally known as the Safe Drinking Water and Toxic Enforcement Act of 1986) is a state-level regulation passed by the State of California in 1986.

The Act is administered by the Office of Environmental Health Hazard Assessment (OEHHA) under the California Environmental Protection Agency (Cal/EPA).

Prop 65 has two core requirements: first, no discharge of chemicals known to cause cancer or reproductive toxicity into California drinking water sources; second, no sale of products containing such chemicals to California residents without providing a clear and reasonable warning.

As of 2023, the Prop 65 chemical list includes over 950 chemicals, covering three major categories: carcinogens, reproductive toxicants, and developmental toxicants.

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Applicable Product Scope

Applicable product and service categories

Prop 65 applies to all consumer products sold or distributed in California, including but not limited to: food and beverages, cosmetics and personal care products, toys and children's products, clothing and textiles, jewelry, electronics and appliances, furniture and home goods, building materials, automotive products, office supplies, sporting goods, and pet products. It also covers environmental exposures in workplaces, schools, and commercial establishments. For foreign products imported into California, California importers or distributors bear compliance obligations. A distinctive feature of Prop 65 is its citizen lawsuit provision, which allows any individual or organization to sue non-compliant businesses that fail to provide warnings, leading to numerous private lawsuits (often referred to as "bounty hunter" litigation).

03

Limit Requirements

Technical standards and compliance indicators

Prop 65 does not have uniform substance content limits; instead, it sets limits for carcinogens

Common Carcinogens	NSRL (mcg/day)	Common Product Sources
-----------	----------------	-------------
Lead	15	Jewelry, batteries, ceramics
Cadmium	0.05	Jewelry, pigments
Formaldehyde	40	Wood, textiles
Benzene	6.4	Plastics, rubber
1,4-Dioxane	1,000	Cosmetics, detergents
DEHP	460	Plastic products, cables
PBDEs	Varies by substance	Flame retardants
Common Reproductive Toxicants	MADL (mcg/day)	Common Product Sources
-----------------	----------------	-------------
Lead	0.5	Jewelry, ceramics, batteries
Phthalate DEHP	410	Plastics, food packaging
Phthalate BBP	8,800	Cosmetics, plastics
Phthalate DBP	8,200	Cosmetics, adhesives
Bisphenol A (BPA)	3	Food containers, thermal paper
Mercury	0.3	Batteries, lamps
Toluene	80,000	Solvents, adhesives
Cadmium	4.1	Jewelry, pigments

1. Carcinogens (No Significant Risk Level, NSRL)

2. Reproductive Toxicants (Maximum Allowable Dose Level, MADL)

NSRL is defined as the daily exposure level that results in a cancer risk of no more than one in 100,000 (1/100,000) over a lifetime of exposure.

MADL is defined as the daily exposure level that does not cause observable harm to the reproductive system (typically based on animal study data divided by a 1,000-fold safety factor).

"WARNING: This product can expose you to [chemical name], which is known to the State of California to cause cancer. For more information, go to www.P65 Warnings.ca.gov."

3. Warning Label Requirements

If the exposure to a Prop 65 listed substance in a product exceeds the NSRL or MADL, a clear and reasonable warning must be provided on the product. The 2021 updated warning label format requirements are as follows:

For reproductive toxicants, the warning text changes to "...cause birth defects or other reproductive harm...".

The warning sign must use a triangular exclamation point icon and the word "WARNING" in font size no smaller than other consumer information on the product label.

04

Test Methods & Standards

Core testing items and indicators

Prop 65 testing typically follows these methods

Total Content TestingUsing XRF screening or chemical digestion methods (EPA 3050B, EPA 3051 A, CPSC-CH-E1001-08.3, etc.) to determine total content of Prop 65 listed substances in products.

Migration/Extractable TestingSimulating actual consumer exposure conditions (e.g., mouthing, skin contact, or food migration), using artificial saliva (EN 71-3 method), artificial sweat (EN 1811 method), or food simulants (FDA or EN 1186 method) for extraction, then determining migration levels.

Exposure AssessmentBased on actual product use scenarios, estimate the consumer's average daily exposure.Exposure Assessment considers factors such as chemical substance concentration in the product, daily contact time and frequency, and exposure route (oral, dermal, or inhalation).

Compliance determination: Compare the estimated average daily exposure with NSRL (carcinogens) or MADL (reproductive toxicants). If the threshold is exceeded, warning labels must be affixed or chemical substance content must be reduced.

05

Certification Process

Complete steps from application to certification

Prop 65 Compliance Process
Step 1	Identify Prop 65 listed substances that may be present in the product (refer to the OEHHA published list).
Step 2	Conduct product composition screening tests (XRF or chemical analysis).
Step 3	Perform Migration/Extractable Testing。
Step 4	Conduct Exposure Assessment。
Step 5	If exposure exceeds NSRL or MADL, choose one of the following compliance methods:
Step 6	Continuously monitor product compliance and regularly update test data.

a) Affix Prop 65 warning labels (simplest compliance method)

b) Improve product design or materials to reduce substance content below safe thresholds (exempts warning obligation)

c) Provide alternative warning methods (e.g., website notices, checkout counter notices, etc.)

06

Required Documents & Notes

Required documents and materials checklist

The following documents are required for Prop 65 compliance assessment: Product name and model

Product teardown list and BOM (indicating materials of each part)

Product use scenario description (contact method

Samples. Note: Prop 65 is a California state regulation that only applies to products sold or distributed in California. However, virtually all products targeting the US market enter California distribution channels, making Prop 65 compliance a de facto national requirement. The greatest risk of Prop 65 comes from citizen lawsuits (private "bounty hunter" litigation), with thousands of Prop 65 lawsuits filed each year. Simply affixing Prop 65 warning labels is the easiest compliance method, but excessive warning labels can reduce product competitiveness and consumer trust. It is recommended to minimize Prop 65 listed substance content through product testing and material control to avoid unnecessary warnings. The Prop 65 list is continuously updated (at least once per year); regular review of the latest list is recommended. OEHHA requires manufacturers to identify specific chemical substance names on each warning (per 2018 updated requirements), rather than a generic "contains chemicals" statement. For cross-border e-commerce and export products sold on platforms like Amazon, Prop 65 requirements also apply.

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