California Proposition 65 restricts heavy metals, phthalates, and other substances in consumer products sold in California. The regulation applies to most consumer products, and for all age groups. In this guide, we explain what importers and Amazon sellers must know about restricted substances, warning labeling, lab testing, and compliance risks.
What is California Proposition 65?
California Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, is a state regulation in California that applies to consumer products. This regulation mainly prohibits:
a. The unrestricted use of toxic chemicals in consumer products, without using the appropriate warnings
b. The discharging of listed substances into the drinking water source
The aim of California Proposition 65 is to protect the people of California from harms caused by exposure to certain types of chemical substances.
The California Office of Environmental Health Hazard Assessment (OEHHA), which administers California Proposition 65, updates periodically, usually once a year, the list of chemicals that can cause the following health issues to humans:
- Developmental diseases
- Female or male reproductive problems
Currently, around 1,000 chemicals have been added to the list and the number is likely to continue to grow in the future.
Which substances are covered by California Proposition 65?
California Proposition 65 regulates both naturally occurring and synthetic chemicals that are added to the products and that can cause health issues to humans.
In order to quantify the doses of allowable chemicals for different products, California Proposition 65 established a mechanism called “Safe Harbor Levels”, which sets the maximum exposure limit of the listed substances. There are two kinds of substance levels:
a. No Significant Risk Levels (NSRLs) for chemicals that might cause cancer
b. Maximum Allowable Dose Levels (MADLs) for chemicals that might induce reproductive problems
California Proposition 65 refers to the definition of chemicals of “no significant risks” in section 25705, Title 27 of the California Code of Regulations, which explains that the No Significant Risk Level (NSRL) is a daily intake level that could cause at most the 0.001% risk of cancer through lifetime exposure.
The NSRL value of each listed substance in California Proposition 65 is calculated through scientific research and risk assessments. OEHHA releases scientific reports revealing the methodologies and findings for some of the listed chemicals. For example, you can browse this report to see the NSRL summary of Benzene.
California Proposition 65 elucidates the definition of the Maximum Allowable Dose Levels (MADLs) in section 25801, Title 27 of the California Code of Regulations, explaining that it represents a daily level of exposure having no observable reproductivity damaging effect when multiplied by 1,000.
Examples of Restricted Substances
In the table below, we provide a non-exhaustive list of chemical substances that are regulated by California Proposition 65. For each substance, we also list the NSRL and MADL (when available), and examples of products where the substance might be found.
|Substance||NSRL (μg/day)||MADL (μg/day)||Product examples|
|Arsenic (inorganic arsenic compounds)||a. 0.06 (inhalation)|
b. 10 (except inhalation)
|Benzene||a. 6.4 (oral)|
b. 13 (inhalation)
|a. 24 (oral)|
b. 49 (inhalation)
|Toys, latex mattresses, food packaging, safety helmets, sports equipment, plastic glasses, medical devices|
|Beryllium||0.1||/||Bicycle frames, ceramics, golf clubs, laser, and electro-medical devices|
|Cadmium||0.05 (inhalation)||4.1 (oral)||Children’s jewelry, ceramics, glasses|
|Chromium, Hexavalent (Cr+6))||0.001 (inhalation)||/||Leathery products, packaging materials, cosmetics, toys|
|Lead||15 (oral)||0.5||Child care products, toys, food contact products, furniture, cosmetics, electronics, batteries, packaging materials|
|Phthalate (DEHP)||310||/||Textiles, charging cables, plastic products|
|Phthalate (DIDP)||/||2200||Textiles, stationery products, shower curtains, construction products|
|Phthalate (DINP)||146||/||Textiles, PVC flooring, wire, and cable insulation, tubing, garden hoses, inks, pigments, adhesives, paints, lacquers|
|Phthalate (DBP)||/||8.7||Textiles, perfumes, nail polish|
|Phthalate (DNHP)||/||2200 (oral)||Cables, cosmetic bags, thermometer, PVC gloves, jewelry organizers, packaging cases|
|Asbestos||100 fibers/day (inhalation)||/||Household appliances, crayons, makeup products|
Which product categories are covered by California Proposition?
As already mentioned, California Proposition 65 covers all consumer products. Here some examples of covered category products:
- Apparel and textiles
- Leathery products
- Food contact products
- Food packaging
- Child care products
- Children’s jewelry
- Sport equipment
- Cosmetics and personal care products
Since California Proposition 65 restricts products according to daily intakes, there are some categories of products that, by definition, are considered more “risky”, including food contact products, child care products, and apparel, especially underwear and other clothing items that are designed to be in direct contact with the skin.
As an example, consumers are less likely to inhale toxic substances from a battery that is placed inside their aircon remote controller than from the ceramic cup where they drink their coffee every morning.
With that said, all consumer products shall comply with the regulation.
Warning Labeling Requirements
California Proposition 65 has set up a warning label system to notify consumers that certain consumer products contain, or might contain, carcinogens or toxins to human reproductive systems.
Importers and manufacturers are required to affix a California Proposition 65 warning label under the following circumstances:
a. Products that (may) contain listed chemical substances greater than the Safe Harbor Levels
b. Products that contain listed chemical substances for which California Proposition 65 didn’t specify the Safe Harbor Levels yet (unless the business can prove that the chemical exposure do not have potential risks to cause cancer or reproductive harm to the users)
The party who labels the product (i.e. manufacturers or importers) is responsible for the determination of the levels of exposure to listed chemicals.
California Proposition 65 proposes that such a process shall be done through scientific, rigorous, and quantitative assessments.
Practically speaking, the only way to assess if your product is exempt from the warning requirements, is to perform the necessary chemical tests. Thus, we advise you to consult a qualified professional party such as a testing laboratory, to determine the chemical substance levels of your products.
Label Format and Content
The requirements for the warning label, including format and content, are described in Title 27, Article 6 of the California Code of Regulations.
The warning label should be able to convey clear and unmisleading information to the consumers that might be exposed to the listed chemicals. In particular, the warning label should follow the rules listed below.
Warning symbol and text
A triangle warning symbol shall be placed to the left of the word “WARNING”. You can download the warning symbol on OEHHA’s website. Note that you can select the color (i.e. black and white or black and yellow) and size of the symbol.
The word “WARNING” shall be written in bold, capital letters.
Warning statements for products that contain listed carcinogens above the limits should be written in this form:
“This product can expose you to chemicals including [name of one or more chemicals], which is/are known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.”
Warning statements for products that contain listed substances that could cause reproductive harms should be written in this form:
“This product can expose you to chemicals including [name of one or more chemicals], which is/are known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.”
If the products contain both listed carcinogens and reproductive toxins, you shall include both risks in the warning:
“…to cause cancer and birth defects or other reproductive harm…”
Lab Testing Requirements
If you want to avoid adding a warning label to your product, you shall make sure that it doesn’t contain restricted substances above the Safe Harbor Levels.
This can be done via volatile organic compounds (VOCs) emission testing or similar testing methods. Here a shortlist of companies that offer California Proposition 65 compliance test services:
- TÜV Rheinland
- Berkeley Analytical
- Applied Technical Services
Further, testing companies also keep track of new substances added to the list of restrictions, and changes to the limits.
California Proposition 65 Requirements for Amazon Sellers
Amazon requires sellers that are listing, or wish to list, products on Amazon.com to comply with California Proposition 65.
Specifically, Amazon requires sellers to use their internal system to disclose product information including California Proposition 65 warning type, and relevant chemical names. The warning label shall be affixed on the product, and the same information shall also be displayed on the product listing page.
The following list includes examples of Amazon’s product categories that might require California Proposition 65 warning:
- Lead crystal glasses
- Ceramic tableware
- Electrical cords
- Beauty products
However, as said, the regulation applies to all consumer products. The above list only includes some examples provided by Amazon.
These type of businesses are exempt from California Proposition 65 requirements:
- Businesses with fewer than 10 employees
- Governmental agencies
- Public water systems
However, note that the regulation might be relevant also for businesses that employ less than 10 people. As an example, if you are importing consumer products to resell them to retailers or other companies that might have 10 employees or more, practically speaking you might still have to comply, even if you only 2 employees.
If a product that is sold in California is found to contain one or more restricted chemicals above the Safe Harbor Levels without having the required warning label, the responsible party might be subject to a penalty as high as $2,500 per violation per day.
Products manufactured in China, Vietnam, and other countries are not California Proposition 65 compliant by default. On the contrary, manufacturers only ensure compliance with California Proposition 65 if explicitly instructed to do so – which in turn may require that they procure materials (e.g. fabrics or plastic granule) that are California Proposition 65 compliant.
Products made for other markets – without such strict substance regulations – may therefore contain amounts of lead, cadmium, phthalates, and other substances restricted in California Proposition 65.