Clear and reasonable warning
The warning must be 'clear and reasonable' as defined by the regulations — including the safe-harbor content, placement, and language requirements for consumer products.
SafeHarbor delivers a signed, audit-ready warn/no-warn determination for every SKU — with a documented safe-harbor exposure basis, the correct compliant warning text, and a continuously monitored compliance file — checked against OEHHA’s chemical list and Title 27 safe-harbor levels before a toxicologist and Prop 65 attorney release it.
California’s Proposition 65 requires a clear and reasonable warning before knowingly exposing anyone in California to any of the roughly 1,000 listed chemicals — unless the exposure falls below a safe-harbor level. But the law is enforced not by an agency but by private plaintiffs who are entitled to civil penalties of up to $2,500 per day per violation plus their attorney fees. In 2024, there were more than 1,300 settlements totaling $27.08 million — 87% of which went to plaintiff attorney fees.
Most mid-market brands have no toxicologist on staff and no systematic way to determine whether each SKU needs a warning. They rely on lab tests that report concentrations, not a warn/no-warn call, or they wait until a 60-day notice arrives and then hire a defense attorney at $400/hour. That reactive approach turns every un-warned SKU into a litigation target.
SafeHarbor exists to close that gap with a single, exhaustive determination standard applied identically to every SKU.
We do not guess whether a warning is needed. Every determination is scored against a versioned rule pack tied to the exact text of Title 27, California Code of Regulations, sections 25601–25607, and the OEHHA chemical list. These are the provisions each determination is held to.
The warning must be 'clear and reasonable' as defined by the regulations — including the safe-harbor content, placement, and language requirements for consumer products.
For each chemical detected, the exposure is compared to the No Significant Risk Level (NSRL) for carcinogens or the Maximum Allowable Dose Level (MADL) for reproductive toxicants. If below, no warning is required.
The warning must include the specific chemical name(s) and the statement: 'This product can expose you to [chemical name], which is known to the State of California to cause cancer [and/or birth defects or other reproductive harm].'
For consumer products, the warning must be provided on the product label, or if not feasible, via a sign, shelf tag, or electronic warning at the point of sale — with specific requirements for online sales.
The determination must be based on a reasonable exposure assessment considering the product's use, frequency, and duration — documented in the defense file.
The determination must be reviewed and updated annually, or whenever the OEHHA list changes, to ensure continued compliance.
AI extracts and drafts. Deterministic rules — running as code, outside the model — decide what is complete. A qualified toxicologist and a Prop 65 attorney sign every release. That order is never reversed.
Upload your product catalog and formulations. We return a free completeness read: which SKUs have a determination, which are missing, and which chemicals are likely present.
As your authorized clerical agent, we ingest your BOMs, supplier disclosures, and lab reports, and screen every ingredient against the OEHHA chemical list.
For each detected chemical, we draft an exposure assessment comparing the expected intake to the NSRL or MADL, using standard exposure scenarios.
The chemical list is checked against the latest OEHHA update; the exposure assessment is verified against safe-harbor levels; the warning text is validated for regulatory compliance. Any failure blocks release.
A qualified toxicologist reviews the exposure assessment and makes the exposure call. A Prop 65 attorney reviews the determination and signs the final warn/no-warn decision.
You receive the signed determination per SKU, the correct warning text for label and online, the exposure assessment rationale, and a monitored defense file — ready for your records and retailer demands.
The deliverable is completeness itself — every chemical screened, every exposure assessed, every warning element accounted for or explicitly exception-coded. Nothing is left implicit.
The gates that decide completeness are code, not a model's opinion. A drafting error cannot slip past a safe-harbor requirement.
We prepare documentation and run searches as your clerical agent. We never give legal advice, contact plaintiffs, or represent you in litigation.
Simple, predictable, and aligned with a documentation standard — not a cut of any settlement or recovery.
Start with a free Compliance Gap Scan. Send your product catalog and formulations and we'll return a completeness read against every safe-harbor requirement.
Documentation-completeness service · not legal advice · the brand retains all compliance responsibility.