Why Proposition 65 Compliance Matters for Your Business
Proposition 65 compliance is required for any business with 10 or more employees selling products in California that contain chemicals known to cause cancer or reproductive harm. Here’s what you need to know:
Key Requirements:
– Warning labels must include specific chemical names and the yellow triangle symbol
– Safe harbor levels determine when warnings are required (NSRL for cancer, MADL for reproductive harm)
– Penalties can reach up to $2,500 per violation per day
– Timeline gives businesses 12 months to comply after a chemical is listed
Who Must Comply:
– Manufacturers, importers, distributors, and retailers
– Online sellers (including Amazon third-party sellers)
– Any business exposing consumers to 900+ listed chemicals above threshold levels
California’s Safe Drinking Water and Toxic Enforcement Act—commonly called Proposition 65—passed with a 63% voter margin in 1986. Since then, it’s created a complex web of compliance challenges that can shut down product sales overnight. The law covers everything from lead in electronics to formaldehyde in textiles, with private “bounty hunter” attorneys filing over 30,000 violation claims targeting more than 100,000 products between 1988 and 2020.
What makes this particularly tricky is the trend toward “over-warning”—many businesses slap generic labels on everything rather than test their products, diluting the law’s consumer protection purpose while still facing litigation risk.
I’m Eric Neuner, founder of NuShoe Inc, and through our quality correction work we’ve handled thousands of projects involving Proposition 65 compliance issues for footwear brands. Over 30 years in the industry has shown me that proactive compliance beats reactive damage control every time.
Simple guide to Proposition 65 compliance terms:
– california proposition 65 testing
– prop 65 warning should i worry
Proposition 65 Compliance 101: Purpose, Scope & Who Must Comply
Think of Proposition 65 compliance as California’s way of keeping businesses honest about chemical exposure. The Office of Environmental Health Hazard Assessment (OEHHA), which is part of CalEPA, runs the whole show. They’re the ones updating that ever-growing list of chemicals and making sure everyone follows the rules.
The law has a pretty straightforward mission: stop harmful chemicals from getting into drinking water and make sure people know when they’re being exposed to potentially dangerous substances. It’s like having a watchdog that barks whenever there’s a chemical risk lurking around.
Here’s where it gets interesting for businesses. If you have 10 or more employees and you’re selling products that contain any of those roughly 900 listed chemicals above safe levels, you’re in the compliance game. We’re talking about everything from food and apparel to electronics and automotive parts—basically, if it’s a product that consumers touch, use, or consume, it probably falls under this law.
The good news? Small businesses with fewer than 10 employees get a pass, along with government agencies and public water utilities. But here’s the catch that trips up a lot of companies: it doesn’t matter where you make your products. If you’re selling to California customers, even from across the country through online sales, you still need to comply.
OEHHA actually put together a helpful resource called Proposition 65 in Plain Language that breaks down the complex legal stuff into terms real humans can understand.
Why the Act Exists & How It Works
The science behind Proposition 65 isn’t just pulled out of thin air. For cancer-causing chemicals, they set the bar at a 1-in-100,000 lifetime cancer risk. For reproductive toxins, it’s one-thousandth of the no observable effect level (NOEL). These aren’t arbitrary numbers—they’re carefully calculated thresholds that help separate real dangers from the tiny traces of chemicals we encounter every day.
Back in 1986, California voters weren’t just worried about big industrial spills. They wanted protection from everyday chemical exposure that was flying under the radar. This wasn’t some backroom political deal—it was a direct voter initiative that passed with solid public support because people were genuinely concerned about what they were breathing, drinking, and touching.
Who Is on the Hook for Proposition 65 Compliance
The responsibility doesn’t stop at just one link in the chain. Manufacturers, importers, distributors, retailers, and online sellers all have skin in the game. Amazon learned this the hard way—they faced over 1,000 Prop 65 “Intent to Sue” notices as of August 2019. That’s a lot of legal paperwork for one company.
Smart businesses use written responsibility agreements to sort out who does what. For example, a manufacturer might promise to provide all the warning materials to retailers, and those retailers confirm they got everything by February 28th each year. It’s like passing the baton in a relay race—everyone needs to know when it’s their turn to run.
The tricky part about e-commerce is that it’s made enforcement more complicated. When you’re selling online, you’re potentially reaching customers everywhere, which means navigating compliance rules you might not even know exist.
Decoding the Chemical List & Safe Harbor Levels
Understanding the California Proposition 65 list of chemicals is like trying to hit a moving target. With over 900 substances and counting, this list gets updated at least once a year—sometimes more often when new research emerges.
OEHHA adds chemicals through four main pathways. The Carcinogen Identification Committee (CIC) handles cancer-causing substances, while the Developmental and Reproductive Toxicant Identification Committee (DART) focuses on reproductive harm. Authoritative body determinations bring in findings from respected organizations like the EPA or WHO. Finally, labor code requirements automatically include certain workplace hazards.
Here’s where it gets practical for Proposition 65 compliance: OEHHA has established over 300 safe harbor levels that act as your compliance roadmap. No Significant Risk Levels (NSRLs) apply to cancer-causing chemicals—think of these as the daily exposure amount that would create less than a 1-in-100,000 lifetime cancer risk. Maximum Allowable Dose Levels (MADLs) cover reproductive toxins, set at one-thousandth of the no observable effect level.
Feature | NSRL (Cancer) | MADL (Reproductive) |
---|---|---|
Risk Level | 1 in 100,000 lifetime | 1/1000 of NOEL |
Calculation Basis | Daily exposure over 70 years | Observable effect threshold |
Common Examples | Lead (0.5 µg/day), Formaldehyde (40 µg/day) | DEHP (410 µg/day), Toluene (7,000 µg/day) |
If your product’s chemical exposure falls below these thresholds, you’re in the clear—no warning required. But here’s the catch: only about one-third of listed chemicals have established safe harbors. For the rest, you’ll need lab testing, exposure modeling, or documentation to prove safety.
In our work with footwear brands, we see the same troublemakers again and again. Lead shows up in metal hardware and decorative elements. Phthalates lurk in flexible plastics and synthetic materials. Formaldehyde hides in adhesives and finishes. Chromium VI appears in leather tanning processes—a particular headache for shoe manufacturers.
Safe Use Determinations (SUDs) offer another compliance pathway when OEHHA determines that specific product uses pose no significant risk despite containing listed chemicals. These are rare but valuable when available.
Staying Ahead of New Listings
The good news? You’re not expected to be psychic. When OEHHA adds a new chemical, businesses get a 12-month warning window and a 20-month discharge prohibition window. This breathing room lets you test products, reformulate if needed, or prepare warning labels.
Smart businesses don’t wait for surprises. We recommend monitoring OEHHA notices quarterly and maintaining supplier questionnaires to catch potential issues early. Your suppliers should be your first line of defense—they know what goes into their materials.
Lab testing and documentation become your best friends here. Keep detailed records of material safety data sheets, test reports, and supplier certifications. When that 60-day notice arrives (and it might), you’ll need proof that you acted reasonably.
For footwear and leather goods specifically, chromium VI has become a major concern. Our Chromium VI Levels testing helps brands stay ahead of this common compliance challenge before it becomes a crisis.
The key is building Proposition 65 compliance into your regular quality control process rather than treating it as an afterthought. Trust me—it’s much easier to test a few samples during development than to recall thousands of units from California stores.
Crafting Clear & Reasonable Warnings: Labels, Online & On-Site
Getting your warning labels right is where Proposition 65 compliance gets real. The 2018 regulations completely changed the game, moving away from vague “this product contains” language to much clearer “can expose you to” warnings that actually tell consumers what they’re dealing with.
The new rules require specific elements: your warning must include at least one chemical name (no more hiding behind generic language), display the triangular yellow warning symbol, link to www.P65Warnings.ca.gov for more information, and use at least 6-point font so people can actually read it.
Here’s where it gets interesting—California just passed amendments taking effect January 1, 2025, that allow “CA WARNING” or “CALIFORNIA WARNING” as signal words. This gives businesses more flexibility while maintaining clarity. The Title 27 Article 6 side-by-side PDF shows exactly how the old and new requirements stack up.
You can choose between full-length warnings (26-44 words) or short-form versions (8-14 words), depending on your space constraints. Different product categories get custom options too—food warnings look different from furniture warnings, which look different from automotive parts warnings.
Anatomy of a Compliant Label for Proposition 65 Compliance
Every compliant warning needs five essential pieces that work together like a recipe. Miss one ingredient and the whole thing falls apart.
Start with the yellow triangular symbol—it’s not optional and provides instant visual recognition. Next comes your bold “WARNING” text as the signal word that grabs attention. Then you need chemical identification that names at least one specific listed substance (goodbye, generic warnings).
Your risk description must clearly state whether you’re dealing with cancer, reproductive harm, or both. Finally, include the URL reference to www.P65Warnings.ca.gov so consumers can learn more.
Placement matters more than most people realize. On-product warnings give you the strongest legal protection, followed by packaging, then instruction manuals, and finally point-of-sale notices. Think of it as a hierarchy—the closer to the product, the better your defense.
E-Commerce & Digital Sales Challenges
Online sales create a whole different set of headaches for Proposition 65 compliance. Your product display pages must include a clearly marked hyperlink labeled “CA WARNING,” “CALIFORNIA WARNING,” or “WARNING”—and it needs to be obvious, not buried in fine print.
The 60-day update rule keeps retailers on their toes. Once manufacturers notify you about warning requirements, you’ve got two months to get those warnings live on your site. Miss that deadline and you’re in violation territory.
Mobile-first design adds another layer of complexity. Your warning text must stay legible on tiny phone screens while meeting minimum size requirements. It’s a balancing act between compliance and user experience. Amazon’s massive volume of Prop 65 notices shows just how seriously platforms take these requirements—they can’t afford to mess around.
Our California Proposition 65 Testing services help e-commerce brands catch issues before customers do, saving you from the scramble of emergency warning updates.
Location-Based & Category-Specific Warnings
Not all warnings are created equal. Different exposure scenarios need different approaches, and California recognizes this with custom warning formats.
Parking garages need diesel exhaust warnings since people are breathing those fumes. Dental offices must address mercury exposure from amalgam fillings. Alcoholic beverages get specific reproductive harm language that’s different from other products.
The multi-language requirement kicks in when your other product information appears in non-English languages. If your packaging is bilingual, your warnings need to be too. Fortunately, the regulations provide safe harbor translations for major languages, so you don’t have to guess at the right wording.
Recreational marine parts and automotive components each have their own warning templates that account for how people actually use these products. It’s not one-size-fits-all—California wants warnings that make sense in context.
Enforcement, Penalties & Litigation Shields
Understanding who can come after your business for Proposition 65 compliance violations helps you prepare better defenses. Three groups have enforcement power: the California Attorney General, district and city attorneys, and private individuals acting in the public interest.
Here’s where it gets interesting—and expensive. Private “bounty hunter” attorneys handle most enforcement cases, creating a cottage industry around Prop 65 violations. Between 2000 and 2020, businesses paid over $370 million in settlements. That’s real money coming out of company budgets.
The enforcement process starts with a 60-day notice period. Think of this as your last chance to fix problems before facing a lawsuit. Once you receive notice, you can cure violations, negotiate settlements, or prepare for litigation. Smart businesses use this window wisely.
Penalties can reach $2,500 per violation per day, though actual settlements often land much lower. The math gets scary fast when you multiply daily penalties across multiple products and months of violations. One judge famously criticized certain cases as merit-free “shakedowns,” suggesting some deserved awards “closer to a dollar ninety-eight” rather than hundreds of thousands.
The over-warning trend has created its own problems. Many businesses slap generic warnings on everything rather than test their products. This approach dilutes the law’s consumer protection purpose while still leaving companies vulnerable to litigation. Courts and regulators increasingly frown on this lazy compliance strategy.
Reformulation versus default labeling presents a key strategic choice. Companies can remove problematic chemicals, improve manufacturing processes, or simply warn about everything. The best approach depends on your products, margins, and risk tolerance.
Indemnity contracts between supply chain partners help allocate responsibility. Manufacturers might agree to defend retailers, while importers could indemnify distributors. These agreements work best when paired with proper insurance coverage.
Insurance considerations deserve careful attention. Some policies exclude Prop 65 claims entirely, while others require specific riders for coverage. Review your policies with brokers who understand California’s unique liability landscape.
For more context on the broader warning landscape, check out this LA Times investigation that explores how ubiquitous warnings have become.
Mitigating Risk & Strengthening Proposition 65 Compliance
Smart risk mitigation combines several proven strategies that actually work in the real world. Due diligence testing provides your strongest legal defense. Laboratory analysis of products and materials creates documentation showing either compliance or the need for warnings. Courts respect businesses that test their products properly.
Exposure modeling becomes crucial when safe harbor levels don’t exist for your specific chemicals. Qualified toxicologists can calculate anticipated exposures under normal use conditions following OEHHA guidelines. This scientific approach often proves exposures fall below concerning levels.
Record retention under attorney-client privilege protects your compliance documentation from findy in litigation. Work with qualified legal counsel to structure your testing and analysis properly. This isn’t about hiding problems—it’s about protecting legitimate compliance efforts.
Safe Use Determination petitions offer another pathway when you believe your products pose no significant risk despite containing listed chemicals. OEHHA evaluates these requests based on actual exposure scenarios rather than theoretical maximums.
Supplier certifications create accountability throughout your supply chain. Require vendors to certify their materials comply with Prop 65 or provide proper warning support. Annual renewals keep everyone focused on compliance.
Internal compliance calendars help track chemical list updates, supplier agreements, and warning maintenance. Set quarterly reviews to catch new listings before they become violations.
Our Proposition 65 Compliance services provide comprehensive support for brands navigating these challenges. We’ve helped hundreds of companies build defensible compliance programs that actually protect against enforcement actions.
Step-by-Step Roadmap to Conquer Compliance Challenges
Getting Proposition 65 compliance right doesn’t have to feel overwhelming. After helping hundreds of footwear brands steer these waters since 1994, we’ve developed a straightforward 8-step process that takes the guesswork out of compliance.
The key is being systematic rather than reactive. Too many businesses wait until they receive a 60-day notice before scrambling to understand their exposure. By then, you’re playing defense instead of offense.
Here’s how we approach Proposition 65 compliance for our clients:
Start with your inventory bill of materials. You can’t protect what you don’t know you have. Catalog every product, component, and material in your supply chain. We focus first on high-risk categories like metal hardware, synthetic materials, adhesives, and any surface treatments or finishes.
Map those materials against the listed chemicals. Cross-reference everything against the current Prop 65 list of over 900 substances. The usual suspects in our industry include lead in metal components, phthalates in flexible plastics, formaldehyde in adhesives, and chromium compounds from leather tanning.
Get laboratory testing done right. Test representative samples using accredited labs that understand Prop 65 requirements. We always prioritize products with the highest sales volumes or greatest risk profiles first. It’s better to know where you stand than to guess.
Compare your results to safe harbor levels. This is where the rubber meets the road. Evaluate test results against established NSRLs for cancer-causing chemicals and MADLs for reproductive toxins. Document which products need warnings and which fall safely below the thresholds.
Perform exposure assessments for tricky cases. When chemicals don’t have established safe harbor levels, you’ll need to model how much exposure consumers actually get under normal use conditions. This often requires working with toxicologists who understand OEHHA’s guidelines.
Make the warning versus reformulation decision. This is always a business judgment call. Sometimes changing suppliers or specifications costs less than dealing with ongoing warning obligations and potential litigation. We help clients run the numbers both ways.
Draft and place your warnings properly. Implement compliant warnings using the safe harbor language and placement requirements we covered earlier. Train your staff on proper application and maintenance—consistency matters for legal protection.
Monitor updates and audit suppliers regularly. The chemical list updates at least annually, and enforcement trends shift constantly. Establish quarterly review cycles and maintain defensible documentation throughout the process.
Tools & Resources for Ongoing Proposition 65 Compliance
The OEHHA database gives you searchable access to all listed chemicals and current safe harbor levels. Bookmark it and check it regularly. The 60-day notice search tool helps you monitor what enforcement actions are trending in your industry.
OEHHA’s interpretive guidelines clarify complex scenarios that come up in real-world applications. Industry associations often provide sector-specific guidance that’s more targeted than general resources.
We recommend creating an internal compliance calendar tied to OEHHA’s annual update schedule. Mark key dates for list updates, supplier audits, and documentation reviews. Staying proactive beats scrambling to respond every time.
The reality is that Proposition 65 compliance becomes much more manageable when you break it into these systematic steps. It’s not about perfection on day one—it’s about building a defensible process that protects your business and serves your customers.
Frequently Asked Questions about Proposition 65 Compliance
Do I always need to test every product?
Testing every single product isn’t always necessary, but you’ll need a smart strategy either way. Risk-based testing lets you focus your budget on products most likely to contain listed chemicals—think metal components, painted surfaces, or flexible plastics that might contain phthalates.
The key is having defensible documentation regardless of your approach. Some businesses test representative samples from each product line, while others rely on supplier certifications and material safety data sheets. Just remember that choosing not to test doesn’t eliminate your liability if a product actually contains Proposition 65 chemicals above safe harbor levels.
We’ve seen brands get caught off guard when they assumed their products were safe without verification. A small investment in testing often prevents much larger problems down the road.
What if no safe harbor exists for my chemical?
This scenario comes up more often than you’d think, especially with newer chemicals or specialized applications. You have three main pathways when OEHHA hasn’t established safe harbor levels yet.
First option: Provide warnings for any detectable exposure. This is the most conservative approach and offers strong legal protection, though it may impact sales.
Second option: Calculate your own exposure assessment following OEHHA’s risk assessment guidelines. This requires toxicological expertise but can demonstrate that your specific use poses minimal risk. Many businesses hire consultants for this type of analysis.
Third option: Petition OEHHA for a Safe Use Determination if you believe the chemical use poses no significant risk under normal conditions. This process takes time but creates industry-wide clarity once approved.
Each pathway has trade-offs between cost, timeline, and legal protection. We often help brands evaluate which approach makes most sense for their specific situation.
How does Proposition 65 affect out-of-state online sales?
Location doesn’t matter—any product sold to California consumers must comply with Proposition 65 requirements. This catches many out-of-state businesses by surprise, especially smaller companies just starting to sell online.
E-commerce platforms like Amazon, eBay, and Shopify increasingly require Prop 65 disclosures from all sellers, not just California-based ones. Amazon alone has received thousands of violation notices, making them much more aggressive about requiring compliance documentation.
Digital warnings must appear clearly on product pages before purchase, typically as hyperlinks labeled “CA WARNING” or similar language. Mobile shoppers need to see these warnings just as clearly as desktop users, which creates design challenges for some websites.
The 60-day update rule means online retailers must modify their warnings within two months of receiving notice from manufacturers about chemical content changes. This creates ongoing compliance obligations that many businesses underestimate.
Out-of-state sellers often ask whether they can simply block California customers instead of complying. While technically possible, this approach eliminates access to the nation’s largest consumer market and may violate interstate commerce principles.
Conclusion
Proposition 65 compliance doesn’t have to feel like navigating a minefield. Yes, the law is complex with over 900 chemicals and counting. But here’s what I’ve learned after 30 years in this business: the companies that get ahead of compliance issues sleep better at night and keep their cash flow steady.
At NuShoe Inspect & Correct, we’ve watched too many brands scramble when they receive their first 60-day notice. The phone calls are always the same—panic about shipments stuck at the border, retailers threatening to drop product lines, and legal bills mounting by the day. It doesn’t have to be this way.
Our San Diego location puts us right in the thick of California’s regulatory world. We see the enforcement trends, track the new chemical listings, and understand which industries are getting targeted. More importantly, we’ve developed systems that keep your products moving while the paperwork gets sorted out.
Rapid testing and emergency labeling fixes can often resolve compliance gaps in days, not months. But the real value comes from building compliance into your product development process from the start. The brands we work with long-term rarely face surprises because they’re testing materials before they become finished products.
Whether you’re dealing with chromium in leather, lead in metal hardware, or phthalates in flexible components, we’ve likely seen it before. Our testing capabilities cover the full spectrum of Prop 65 chemicals, and our turnaround times reflect the urgency of keeping California sales channels open.
The bottom line? Proposition 65 compliance is just another cost of doing business in the world’s fifth-largest economy. You can handle it reactively and pay premium prices under deadline pressure, or you can build it into your quality systems and treat it like any other specification.
Don’t let compliance issues derail your California sales. Take a hard look at your current product line and identify the potential trouble spots before they become expensive problems.