Prop 65 Compliance Software¶
If you sell products in California, you are legally required to provide "clear and reasonable" warnings when your product exposes consumers to any chemical listed under California Proposition 65. With over 900 listed substances and frequent updates, tracking your obligations manually is impractical at scale. Prop 65 compliance software automates the screening, declaration, and warning-label workflow so you can ship to California with confidence.
The Problem: Why Manual Prop 65 Management Fails¶
Proposition 65 (formally the Safe Drinking Water and Toxic Enforcement Act of 1986) affects every manufacturer, distributor, and retailer whose products reach California consumers. The list of restricted substances grows every year, and the "clear and reasonable" warning standard has evolved through court rulings — most notably the 2018 "clear and reasonable" warning regulations that mandate specific safe-harbor language.
Common failure points for manual processes include:
- Missed updates: The California Office of Environmental Health Hazard Assessment (OEHHA) adds new chemicals quarterly. Tracking these manually is error-prone.
- Inconsistent declarations: Different business units or suppliers may use different formats, making it impossible to prove compliance during a 60-day notice or private enforcement action.
- Burden on downstream customers: Without a structured output, your customers cannot easily verify that your products are properly labelled.
What Prop 65 Actually Requires¶
Any business with ten or more employees that exposes California residents to a listed chemical must provide a warning. The warning must:
- Identify at least one listed chemical
- State whether the chemical is known to cause cancer, birth defects, or other reproductive harm
- Use the exact safe-harbor language specified in California Code of Regulations Title 27, Section 25601–25612
- Be "clear and reasonable" — meaning prominent, understandable, and transmitted in a manner reasonably calculated to reach the individual before exposure
Exemptions exist for exposures that pose no significant risk (cancer) or are at least 1,000 times below the no-observable-effect level (reproductive toxicity). Proving these exemptions requires detailed material composition data.
What Software Automates¶
Prop 66 compliance software replaces spreadsheets, email chains, and PDF attachments with a structured pipeline:
Chemical screening Upload your bill of materials or product specification. The software cross-references every substance against the current OEHHA Prop 65 list, flagging any matches instantly.
Declaration generation Produce formatted warning statements that match the latest safe-harbor regulatory language. The software tracks version history so you can prove which warnings were active on any given date.
Supply chain roll-up Collect material declarations from your suppliers in a standard format (e.g., IPC 1752 or proprietary schemas). Aggregate the results to build a full product compliance profile.
Public compliance outputs Generate a publicly accessible compliance page for each product. This creates a defensible audit trail and signals to retailers and regulators that you take Prop 65 seriously.
Re-screening on list changes When OEHHA adds or modifies a listing, the software re-screens your entire product portfolio and flags any products that now need updated warnings.
Audit trail and version history Every generated warning, re-screening event, and data submission is timestamped and stored. This creates a defensible record in case of a 60-day notice or private enforcement action.
Software Comparison Table¶
| Feature | Sustalium | Toxnot | Enhesa | 3E |
|---|---|---|---|---|
| Primary role | Verifier (cross-references declarations against Prop 65 list) | Material disclosure and BOM management | Global regulatory horizon scanning | MSDS authoring and chemical compliance |
| Prop 65 specific | Dedicated Prop 65 output with safe-harbor language | General SDS/declaration engine; no Prop 65-specific workflow | Regulatory watch only; no declaration output | Broad chemical database; no structured Prop 65 output |
| Public compliance page | Included for every product | Not available | Not available | Not available |
| Automated re-screening | On every OEHHA list update | Manual re-import required | Alerts only | Manual check required |
| Supply chain data collection | Structured verifier framework with supplier onboarding | Full bill-of-materials import | None | Limited to MSDS collection |
| Pricing | €10 / document / month | Subscription (quote‑based) | Subscription (quote‑based) | Subscription (quote‑based) |
Sustalium: The Verifier for Prop 65 Compliance¶
Sustalium was built to solve one specific problem: making California Proposition 65 compliance auditable, repeatable, and fast. Within the Sustalium framework, the Verifier role is what sets it apart.
When you upload a material declaration or bill of materials, Sustalium cross-references every substance against the current OEHHA Prop 65 restricted substance list. It flags matches, generates the correct safe-harbor warning language, and produces a permanent public compliance page for each product.
How the Verifier works: Sustalium does not guess or generate warnings from scratch. It provides a structured framework and a public output page. Your organisation retains ownership of the underlying data and is responsible for final accuracy and sign-off. Sustalium is the verification engine — you stay in control of the compliance decision.
No other platform in this space gives you a dedicated Prop 65 output page with automated re-screening and safe-harbor language baked in. Toxnot is strong for general material disclosure but lacks a Prop 65-specific workflow. Enhesa monitors regulation changes but does not generate declarations. 3E focuses on SDS authoring rather than product-level compliance verification.
For a full walkthrough of how Sustalium handles Proposition 65 declaration verification, visit the Prop 66 Compliance landing page.
Pricing¶
Sustalium charges €10 per document per month. A document is any single product declaration or bill of materials that you submit for verification. There are no setup fees, no annual commitments, and no per-user licence costs.
What is included:
- Prop 65 chemical screening against the full OEHHA list
- Safe-harbor warning generation
- Public compliance output page (shareable URL)
- Automated re-screening on list updates
- Supplier data collection framework
- Audit-trail history of all warnings generated
Frequently Asked Questions¶
Does Prop 65 apply to my business if I do not have a physical presence in California? Yes. The obligation attaches to the act of placing a product into the California market, regardless of where your business is headquartered. Any company with ten or more employees that sells or distributes products in California must comply.
How often is the Prop 65 list updated? OEHHA updates the list at least once per year, and often more frequently. In 2025 alone, several new substances were added, including certain phthalates and flame retardants. Sustalium re-screens your entire product library automatically after each update.
What is the difference between a "warning" and an "exemption"? A warning informs consumers of the presence of a listed chemical. An exemption applies when the chemical concentration is below the safe-harbour level — no significant risk for carcinogens or 1,000× below the no-observable-effect level for reproductive toxicants. Sustalium helps you evaluate both paths.
Do I need a lawyer to approve Prop 65 warnings? Sustalium provides the structured framework, safe-harbor mapping, and public output page. Your legal or compliance team should review and sign off on final warnings. The software is a verification tool, not a substitute for legal advice.
Can Sustalium integrate with my existing compliance workflow? Yes. Sustalium accepts data via CSV upload, API, or the supplier collection portal. Output pages can be linked from your website, retailer portals, or regulatory submissions.
Get Started¶
Stop relying on spreadsheets and email chains for California Proposition 65 compliance. Sustalium gives you a structured, auditable, and automated verification pipeline in minutes.
Get started now — €10 per document per month. No setup fees. No commitments.