California Proposition 65 for cosmetics and chemical products

The duty attaches to any business with ten or more employees that knowingly and intentionally exposes a person in California to a listed chemical. That includes manufacturers, importers, distributors and retailers, and it includes companies with no California presence at all, if their product reaches a Californian consumer. Ecommerce has effectively made it a national requirement.

Warnings must also be given for online sales before purchase, not only on the pack, and for catalogue sales in the catalogue itself. In practice, responsibility flows up the chain: retailers push it back to suppliers through contractual indemnities, so the brand or manufacturer ends up owning the analysis regardless of where the sale happens.

Enforcement is unusual. Most actions are brought by private enforcers under the bounty provisions rather than by the state, beginning with a 60-day notice of violation. Settlements commonly combine civil penalties with reformulation or labelling commitments, and the cost of defending is often higher than the penalty.

Being on the list does not mean a warning is required. The obligation turns on exposure, not presence. OEHHA publishes safe harbour levels for many listed chemicals:

• NSRL, the No Significant Risk Level, for chemicals listed as carcinogens. Below it, no warning is required.
• MADL, the Maximum Allowable Dose Level, for chemicals listed as reproductive toxicants. Below it, no warning is required.

Both are expressed as daily exposure in micrograms, not as a concentration in the product. Converting a formula concentration into an exposure estimate requires assumptions about how much product is used, how often, and by what route (dermal, oral, inhalation). Those assumptions are the analysis. They are also what a plaintiff will challenge, so the reasoning has to be documented and reproducible, not reconstructed after a 60-day notice arrives.

Where no safe harbour level has been published, the business bears the burden of showing the exposure poses no significant risk. Many companies warn defensively in that situation, which is understandable but not free: over-warning has its own commercial and, increasingly, legal cost.

A compliant consumer product warning normally carries a yellow warning symbol, the word WARNING in capitals and bold, a statement of the risk, the name of at least one listed chemical for each endpoint being warned about, and the URL www.P65Warnings.ca.gov.

OEHHA amended the short-form warning rules, requiring a chemical name and restricting eligibility, with a phase-in period and sell-through for products manufactured before the compliance date. Because the dates have been revised more than once, confirm the current compliance date against OEHHA's published regulation before committing artwork.

Most Prop 65 exposure in these sectors comes from impurities and trace constituents rather than declared ingredients, which is exactly why formula-level screening alone is not enough.

• Heavy metals in mineral pigments, clays and colourants, notably lead and cadmium as trace contaminants.
• Titanium dioxide (airborne, unbound respirable particles), a live issue for loose powders and aerosolised products.
• Ethylene oxide and 1,4-dioxane as residuals from ethoxylated surfactants.
• Formaldehyde, including release from preservative systems.
• Diethanolamine, coal tar dyes, retinol/retinyl esters, and other cosmetic-specific listings.
• Industrial solvents such as methanol, toluene and trichloroethylene in chemical products and cleaning formulations.

Trace contaminants are supplier data, not formula data. The analysis is only as good as the certificates of analysis and specifications you hold against each raw material lot, which is why Prop 65 diligence tends to collapse when raw material documentation is scattered across supplier emails.

A newly listed chemical becomes enforceable twelve months after it is added to the list. That is the entire window in which to screen the portfolio, get supplier confirmations, estimate exposure, decide between reformulation and warning, and reprint packaging. Portfolios of any size cannot do that from a spreadsheet.

1. Screen. Query every raw material and formula for the newly listed substance, including known impurities, not just declared ingredients.
2. Confirm. Issue supplier declarations for the substances where your specification is silent, and record the responses against the material.
3. Assess. Estimate exposure against the NSRL or MADL using documented use assumptions, and record the reasoning.
4. Decide. Reformulate, restrict the channel, or warn. Record who decided and on what evidence.
5. Execute. Update artwork, ecommerce listings and distributor packs, and hold the evidence for the inevitable challenge.

Every step is a data operation. Held properly, a new listing is a morning's work and a defensible file. Held in email, it is a quarter of firefighting and an undefendable position.