An Overview of California’s Proposition 65

Cosmetic products in the United States are subject to regulation at both federal and state levels. Businesses seeking to enter the U.S. market must adhere not only to national standards but also to stringent state-specific laws. California, known for its strict regulatory landscape, exemplifies this through initiatives such as the Safe Cosmetics Act, Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020, Proposition 65. This article provides an overview of Proposition 65 and its relevance to the cosmetics industry.

Understanding Proposition 65

Proposition 65 (Prop 65), formally titled the Safe Drinking Water and Toxic Enforcement Act of 1986, was enacted in November 1986 to safeguard California residents and the drinking water sources from contamination with chemicals linked to cancer, birth defects, or reproductive harm. The law, administered by the Office of Environmental Health and Hazard Assessment (OEHHA) under the California Environmental Protection Agency, requires businesses to provide clear and reasonable warnings about potential exposures to such chemicals in consumer products, including cosmetics, sold in or into California.

The Proposition 65 List

Under Proposition 65, California maintains a list of substances known to cause cancer or reproductive/developmental toxicity. First published in 1987 and updated at least annually, this list included over 900 chemicals as of December 29, 2023. These substances may appear as additives or ingredients in a variety of products, ranging from household items and foods to cosmetics and industrial materials.

While the list does not specify allowable limits for these substances, it provides critical details such as the chemical name, CAS number, toxicity type, listing mechanism, and, and, where applicable, safe harbor levels (SHLs).

Safe Harbor Level

SHLs are exposure thresholds deemed acceptable by OEHHA and are categorized into:

• No Significant Risk Levels (NSRLs): For cancer-causing chemicals.

• Maximum Allowable Dose Levels (MADLs): For chemicals causing reproductive harm.

Currently, OEHHA has established SHLs for over 300 chemicals, with more under development. For chemicals without established SHLs, any detectable presence may require a Prop 65 warning unless businesses can demonstrate negligible exposure risk of cancer or reproductive harm.

Examples of Prop 65-Listed Chemicals in Cosmetics

Below are some chemicals commonly found in cosmetics that are listed under Proposition 65:

Compliance Obligations for Businesses

Businesses selling cosmetic products in California or operating within the state must comply with the specific requirements of Proposition 65:

1. Prevent Discharges: Intentional discharges of listed chemicals into drinking water sources are prohibited. Compliance deadlines for newly listed chemicals are typically 20 months after their addition to the list.

2. Provide a “Clear and Reasonable” Warning: Businesses must evaluate their products and operations to determine potential exposure to Prop 65-listed chemicals. If exposure level exceeds SHLs, businesses—including manufacturers, importers, suppliers, and distributors—must provide a "clear and reasonable” warning to consumers so that consumers can decide whether to buy the product after knowing the chemical information contained in the product. The requirement to provide warnings takes effect one year after a chemical is added to the list.

Notably, businesses with fewer than 10 employees, government agencies, and products with exposure levels of listed chemicals below SHLs can be exempt from Proposition 65 warning requirements and discharge prohibitions. If no SHL exists, any detectable chemical presence requires a warning unless exposure can be proven safe.

Proposition 65 Warning Requirements

Prop 65 warnings must be prominently and conspicuously displayed as compared with other words, statements, designs or devices on the label, labeling, or sign. Key elements include:

• A black exclamation point in a yellow triangle (black and white allowed if yellow is not used on the label).

• The word “WARNING” in bold capital letters.

• Identification of at least one listed chemical.

• A link to the OEHHA Proposition 65 warning website.

Warnings can be displayed in various forms, such as product labels, shelf signs, or electronic notifications. A short-form warning, exempt from specifying the chemical, may be used under certain conditions. The text size of short-form warnings must not be smaller than 6-point type. California recently passed new revisions to labeling requirements and we will be publishing news on this soon.

Below are some examples of the warnings:

Penalties for Violations

Non-compliance with Prop 65 can result in severe consequences, including civil lawsuits, product reformulations, label changes, and penalties of up to $2,500 per violation—each instance of a non-compliant product sold in California counts as a separate violation.

Recommended Resources

• From Federal to State: A Comprehensive Overview of Restricted and Prohibited Ingredients in U.S. Cosmetic Regulations

• Global Oversight: Nanomaterials Regulations in Cosmetic Products
  

• Permitted Freckle-removing and Whitening Ingredients in Cosmetics in Major Countries/Regions Worldwide 

• PFAS in Cosmetics: A Guide to Federal and State Regulations in the U.S.

• The Easiest Path to New Cosmetic Ingredient (NCI) Applications in China: A Case Study of Polymer Ingredients

• APAC Regulations on Plastic Microbeads in Cosmetic Products

• Requirements of Phthalates: Usage Limits in South Korea, Japan, EU, US, and Canada