Prop 65

Materials & Environmental

Safe Drinking Water and Toxic Enforcement Act of 1986

Over 900 Listed Chemicals. $2,500 Per Violation Per Day. Your Suppliers Can't Tell You What's In Their Products.

Prop 65 requires warnings for products containing chemicals known to cause cancer or reproductive harm—with no safe harbor for ignorance. Private enforcers filed over 700 lawsuits last year. Without substance-level supplier data, you're exposed.

Certivo automates chemical identification, supplier declarations, and warning label compliance across your California product portfolio.

900+

Chemicals on the Prop 65 list

$2,500

Maximum penalty per day per violation

60 days

Notice period before private enforcement lawsuits

Regulation Overview

Jurisdiction California, USA (applies to all products sold in California)

Regulatory Body California Office of Environmental Health Hazard Assessment (OEHHA)

Regulation Number Health and Safety Code Section 25249.5 et seq.

Effective Date November 1986 (warning requirements since 1988)

Official Source
OEHHA Prop 65

Key Threshold
No Significant Risk Levels (NSRLs) and Maximum Allowable Dose Levels (MADLs)

What is Prop 65?

California's Safe Drinking Water and Toxic Enforcement Act requires businesses to warn Californians about significant exposures to chemicals that cause cancer, birth defects, or reproductive harm. The regulation applies to any business with 10+ employees selling products in California.

The Prop 65 list contains over 900 chemicals, updated annually by OEHHA. Chemicals include heavy metals (lead, cadmium), solvents, pesticides, and industrial compounds. Safe harbor levels exist for some chemicals, but many have no established threshold.

Enforcement comes primarily through private lawsuits, not government action. Plaintiffs' attorneys issue 60-day notice letters, and most cases settle for $50,000–$100,000. Without substance-level data from suppliers, you cannot defend against claims or prove compliance.

Key Components / Sub-Frameworks

• Obligation
  Required before or at point of exposure

• Warning Requirement
  Clear and reasonable warnings for listed chemicals

• Obligation
  Optional but provides enforcement defense

• Safe Harbor Warnings
  Prescribed warning language meeting legal standard

• Obligation
  Exposure below NSRL = no warning required

• NSRLs
  No Significant Risk Levels for carcinogens

• Obligation
  Exposure below MADL = no warning required

• MADLs
  Maximum Allowable Dose Levels for reproductive toxins

• Obligation
  Must include specific elements

• Short-Form Warnings
  Abbreviated warnings for small products/labels

• Obligation
  Required before purchase completion

• Internet Warnings
  Online disclosure requirements

700+ Prop 65 Lawsuits Filed Last Year. Private Enforcers Are Watching Your Products.

Prop 65 enforcement is plaintiff-driven. Law firms actively test products, identify violations, and issue 60-day notices. Settlement demands typically range from $50,000 to $100,000. Without documented chemical data and compliant warnings, you have no defense.

Key Compliance Requirements

Who Must Comply

• Manufacturers selling products in California
• Importers bringing products into California commerce
• Distributors and wholesalers in California supply chains
• Retailers (online and brick-and-mortar) selling to California consumers
• Private label brands and brand owners
• Any business with 10+ employees exposing Californians to listed chemicals

Key Thresholds

NSRL (Carcinogens)

No warning required if exposure below No Significant Risk Level

MADL (Reproductive)

No warning required if exposure below Maximum Allowable Dose Level

10 Employees

Businesses with fewer than 10 employees exempt

60 Days

Notice period before private enforcement action

Core Obligations

1. Chemical Identification
   Identify products containing Prop 65 listed chemicals
   DEADLINE: Before sale in California

2. Warning Provision
   Provide clear and reasonable warnings on labels, packaging, or point of sale
   DEADLINE: At or before exposure

3. Safe Harbor Compliance
   Use prescribed warning language for legal protection
   DEADLINE: Ongoing

4. Documentation
   Maintain records supporting compliance decisions
   DEADLINE: Ongoing (for enforcement defense)

5. Supplier Data Collection
   Obtain chemical composition data from supply chain
   DEADLINE: Before sale

Prop 65-Specific Pain Points

Suppliers Don't Know What's In Their Products

You ask suppliers for Prop 65 declarations. They send generic certificates saying "compliant" without substance data. When a plaintiff tests your product and finds lead at 0.5 ppm, that certificate is worthless. You need CAS-level chemical data—and your suppliers don't have it.

The 60-Day Notice Letter

A law firm sends a notice letter alleging your product contains DEHP above safe harbor levels. You have 60 days to respond, settle, or prepare for litigation. Your compliance team scrambles to find supplier declarations, test reports, and chemical data that should have been collected before the product shipped.

900+ Chemicals, No Master Test

The Prop 65 list includes 900+ chemicals across carcinogens and reproductive toxins. No single test covers all of them. Safe harbor levels vary by chemical—some have NSRLs, some have MADLs, many have neither. Without structured substance data, you can't determine which chemicals to test or whether warnings are required.

Warning Label Chaos

Short-form warnings require specific elements. Product warnings differ from retail warnings. Internet sales need pre-purchase disclosure. Each product line may need different warning language depending on chemical content. Manual label management across thousands of SKUs creates errors that plaintiffs exploit.

Certivo In Action

Prop 65 Workflow

GET EVIDENCE IN
Collect Chemical Declarations and Substance Data from Suppliers

CORA launches targeted campaigns to collect Prop 65 declarations, chemical composition data, and test reports from your supply chain.

• Automated supplier outreach for Prop 65-specific declarations
• Collect substance-level data including CAS numbers and concentrations
• Accept any format: certificates, test reports, SDSs, spreadsheets
• Track response rates and escalate non-responsive suppliers

MAKE SENSE OF IT
Validate Chemical Data Against the Prop 65 List and Safe Harbor Levels

CORA-powered regulatory intelligence extracts substances from supplier documents, validates against all 900+ listed chemicals, and flags exposures requiring warnings.

• CORA-enabled analysis extracts chemical names, CAS numbers, and concentrations
• Automatic validation against current OEHHA Prop 65 list
• Safe harbor analysis comparing exposures to NSRLs and MADLs
• Real-time alerts when list updates affect your products

PROVE COMPLIANCE OUT
Generate Compliant Warnings and Audit-Ready Documentation

When enforcement notices arrive or customers request compliance confirmation, Certivo delivers complete evidence packages with warning documentation.

• Automated generation of compliant warning labels (long-form and short-form)
• Product-specific warning requirements based on chemical content
• Complete audit trail for enforcement defense
• Customer-ready Prop 65 compliance statements

One Platform. 900+ Chemicals Tracked. Warning Compliance Automated.

Certivo identifies Prop 65 chemicals in your products, validates supplier data against safe harbor levels, and generates compliant warnings—automatically. When OEHHA updates the list, CORA reassesses your portfolio and alerts you to new warning requirements before enforcement notices arrive.

Key Statistics

• 900+ Prop 65 chemicals tracked with automatic list sync
• 99.2% Substance extraction accuracy from supplier documents
• 95% Supplier response rate with CORA-powered campaigns

Frequently Asked Questions

How does Certivo track updates to the Prop 65 list?
Certivo maintains continuous sync with OEHHA's Prop 65 list, incorporating new chemical additions and delistings as they're published. When chemicals are added, CORA reassesses your product portfolio and alerts you to items that may require new warnings—before enforcement notices arrive.

What supplier data does Certivo collect for Prop 65?
CORA collects substance-level data including chemical names, CAS numbers, and concentrations from supplier declarations, test reports, SDSs, and certificates. This data enables safe harbor analysis and provides the documentation needed to defend against enforcement claims.

How does Certivo handle safe harbor threshold analysis?
Certivo validates chemical concentrations against OEHHA's published NSRLs (No Significant Risk Levels) for carcinogens and MADLs (Maximum Allowable Dose Levels) for reproductive toxins. Products with exposures below these thresholds may not require warnings—Certivo documents this analysis for enforcement defense.

Can Certivo generate compliant warning labels?
Yes. Certivo generates both long-form and short-form warnings using OEHHA-prescribed safe harbor language. Warning content is tailored to each product's chemical profile, and the platform supports multiple formats for packaging, point-of-sale, and internet disclosure.

How does Prop 65 compliance relate to other chemical regulations?
Many Prop 65 chemicals are also regulated under REACH, RoHS, CPSIA, and TSCA. CORA-powered regulatory intelligence validates supplier data against multiple frameworks simultaneously, eliminating duplicate data collection and ensuring consistent compliance across jurisdictions.