What substances and products are covered by California Proposition 65 in the United States?

1、 What is California Proposition 65?

California Proposition 65 imposes restrictions on heavy metals, phthalates, and other substances in consumer goods sold in California. This regulation applies to most consumer products and applies to all age groups of consumer goods. In this guide, we explain the information that importers and Amazon sellers must be aware of regarding restricted substances, warning labels, laboratory testing, and compliance risks. California Proposition 65, also known as the Safe Drinking Water and Toxic Substances Implementation Act of 1986, is a state regulation applicable to consumer goods in California. This regulation mainly prohibits:

a. Excessive use of toxic chemicals in consumer goods without warning

b. Discharge the listed substances into drinking water sources

The purpose of California Proposition 65 is to protect people in California from certain types of chemical hazards.

The California Office of Environmental Health Hazard Assessment (OEHHA), which manages California Proposition 65, regularly (usually once a year) updates the list of chemicals that may cause the following health issues to humans:

1. Cancer

2. Developmental issues

3. Reproductive diseases

Currently, approximately 1000 chemical substances have been added to the list, and the list of chemicals may continue to grow in the future.

2、 What substances are covered by California Proposition 65?

California Proposition 65 specifies the addition of natural and synthetic chemicals to products, which may pose health risks to humans.

In order to quantify the dosage of chemicals allowed in different products, California Proposition 65 established a mechanism called the "safe harbor level", which sets the maximum exposure limits for the listed substances, involving the types of substances:

a. The level of chemical substances that may cause cancer is: No Significant Risk Level (NSRL)

b. The level of chemical substances that may cause reproductive problems is: Maximum Allowable Dose Levels (MADL)

Due to the large number of chemical substances on this list, some substances may not be detectable, and the cost of all testing methods is high. Therefore, we do not recommend testing more than 1000 chemicals on the list, but rather evaluating the chemical substances in the products from a product perspective to achieve the purpose of responding to California Proposition 65.

The main requirements for the limit of harmful substances in general products are:

1. Lead (Pb)

2. Phthalates

3. Cadmium

4. Formaldehyde

5. Arsenic (As)

6. BPA Bisphenol A (Disabled)

7. Asbestos asbestos (prohibited)

8. Flame retardant (prohibited)


3、 What products does California Proposition 65 cover?

As mentioned earlier, California Proposition 65 covers all consumer goods. Here are some examples of products that cover categories:

1. Clothing and textiles

2. Leather products

3. Food contact products

4. Food packaging

5. Toys

6. Children's health products

7. Children's jewelry

8. Sports equipment

9. Cosmetics and personal care products

10. Electronic products

11. Battery

Since California Proposition 65, which limits products based on daily intake, some product categories have been defined as having higher risks, including food contact products, child care products, and clothing, especially underwear and other clothing designed to come into direct contact with the skin.

For example, compared to ceramic cups that drink coffee every morning, consumers are less likely to inhale toxic substances from the batteries inside the air conditioning remote control.

Nevertheless, all consumer goods should comply with the regulations.


4、 Warning label requirements

California Proposition 65 has established a warning label system to inform consumers that certain consumer products contain or may contain carcinogens or toxins that can cause damage to the human reproductive system.

Importers and manufacturers must affix California Proposition 65 warning labels in the following situations:

a. (Possible) Products containing listed chemical substances greater than safe harbor levels

b. Products containing chemicals listed in California Proposition 65 that do not specify a safe harbor level (unless the company can demonstrate that chemical exposure does not pose a potential risk of cancer or reproductive harm to users)

It is the responsibility of the product manufacturer or importer to determine the exposure level of the chemical substances contained in the product.

California Proposition 65 proposes that this process should be completed through scientific, rigorous, and quantitative evaluation.

5、 Label format and content

The requirements for warning labels, including format and content, are specified in the following legal provisions: Article 6, Paragraph 27 of the California Regulations

Warning labels should be able to convey clear and non misleading information to consumers who may be exposed to the listed chemical substances. Warning labels should follow the following rules.

6、 Warning symbols and text

The triangle warning symbol should be placed to the left of the word 'warning'. You can download warning symbols on the website. Please note that you can choose the color (black and white or black and yellow) and size of the symbol.

Warning should be written in bold capital letters.

7、 Warning statement

For products with carcinogenic content exceeding the limit, the warning statement should be in the following format:

This product may expose you to chemicals including [name of one or more chemical substances], which California already knows can cause cancer.