A 60-day notice is a short letter. It names a product, a listed chemical, and your company as the business selling into California, and copies the state Attorney General. It arrives from a private law firm rather than a regulator, and the clock started before you opened it. If you import silicone or plastic device accessories — protective cases, dashboard mats, cable organisers, grips — the California Proposition 65 requirements for imported silicone and plastic device accessories sit with you, the business putting the product in front of a Californian, and not with the factory in Shenzhen that molded it.
Most buyers meet Prop 65 one of two ways: a retailer's compliance desk asks for a warning determination before a purchase order is released, or a notice lands. What follows is what the statute does, what inside a molded part tends to trip it, why the safe-harbour warning is a commercial call rather than a compliance one, and what to write into the purchase order so the decision is not yours alone to fund.
Who Prop 65 actually binds
Proposition 65 is the Safe Drinking Water and Toxic Enforcement Act of 1986, codified at California Health & Safety Code §25249.5 and following. Its operative requirement is one sentence long: a business must give a clear and reasonable warning before knowingly and intentionally exposing a person in California to a chemical the state has listed as causing cancer or reproductive harm. California's Office of Environmental Health Hazard Assessment (OEHHA) maintains the list, and the list moves — entries are added, and the exposure levels attached to them are occasionally revised.
Three features of the statute decide how it behaves inside a sourcing relationship.
It attaches to the business doing the exposing — in practice the importer, brand owner, distributor or retailer selling into the state. A molder in Longgang is not doing business in California and is not the target of a notice. You are. Businesses below a headcount threshold sit outside the statute's reach, which is thin comfort for a growing brand.
It is enforced privately as well as publicly. The Attorney General and district attorneys can bring actions, and so can a private party acting in the public interest, after serving a 60-day notice of violation on the alleged violator and on the AG. That private right of action, together with the fee-shifting attached to it, is what produces the steady flow of notices against imported consumer goods. Nobody has to be harmed. Nobody has to complain.
It is a warning statute, not a content limit. Prop 65 does not ban a chemical and does not set a concentration ceiling in your product. It requires a warning above certain exposure levels. That distinction is the most useful thing to understand about the regime, and the one most often lost when a buyer forwards a notice to the factory and gets back a heavy-metal report marked pass. A passing content test is evidence, not an answer. Prop 65 is a document exercise before it is a laboratory exercise — which runs against the instinct most buyers bring to it, and most factories too. It also sits alongside, not inside, the entry paperwork covered in the China import compliance requirements guide: no customs form asks about it, and no broker will raise it.
What actually trips the warning on a molded part
The base polymer is rarely what gets named. Cured silicone elastomer, polycarbonate, ABS and thermoplastic polyurethane are not usually the chemical in the notice. What gets named is the additive package that rides along with the polymer — pigments, plasticisers, flame retardants, stabilisers, residual monomer — plus any metal hardware in the assembly.
| Vector | Where it lives in a case or accessory | Chemical families commonly named in notices | What to ask the factory for |
|---|---|---|---|
| Colour pigments | Masterbatch for plastics; colour paste for silicone | Lead and lead compounds; cadmium compounds, historically in some yellow, orange and red pigment chemistries | Pigment supplier, CAS numbers per colour, heavy-metal declaration per colour code |
| Plasticisers | Soft plastic components, printed logos, inks, any PVC label or hang tag | Phthalate esters | Plasticiser declaration for every soft component including the ink and the label, not just the case body |
| Flame retardants | Housings and structural parts that carry a flame rating | Brominated and chlorinated retardants | Retardant identity — and confirmation of whether your part needs a flame rating at all |
| Residual monomer | Styrenic plastics | Styrene | Resin grade data sheet plus a residual monomer statement from the resin maker |
| Polycarbonate chemistry | PC parts and PC/ABS blends | Bisphenol A | Resin grade, supplier declaration, and a statement on whether any recycled PC is used |
| Metal hardware | Screws, clips, magnets, plated inserts, kickstand pins | Lead in free-machining brass; nickel release | Alloy and plating spec with supplier declaration |
| Cure system residues | Silicone compounds | Varies with the cure chemistry | Whether the compound is peroxide- or platinum-cured, and the post-cure practice |
Three details from inside this product class that are worth more than the table.
Content is not exposure. Labs quote total content in milligrams per kilogram of compound, because that is the cheap, repeatable measurement. The statute is about the dose a person receives. Bridging the two takes a migration or hand-wipe study plus a defensible use scenario — how long the part is held, whether it reaches the mouth, whether it is a child's article. Very few brands commission that study, because for most SKUs it costs more than simply warning.
Some listed chemicals have no adopted safe-harbour level. For carcinogens the level is a No Significant Risk Level; for reproductive toxicants it is a Maximum Allowable Dose Level. Where OEHHA has adopted neither, a defendant carries the burden of showing the exposure falls below the statutory threshold — an expert exercise, not a certificate. Ask your consultant which of your candidate chemicals have adopted levels before you scope any testing.
Carbon black behaves differently than buyers expect. It appears on the list in a form tied to airborne unbound particles. A pigment bound into a cured elastomer is not ordinarily that exposure route, which is why black cases are not the notice magnet a naive reading of the list would suggest. This is exactly the sort of nuance that a single-line content test cannot resolve and a written exposure rationale can.
The other recurring trap is recycled content: recycled PC or ABS is the most common route by which an additive nobody specified appears in a compound nobody changed. If your specification is silent on it, your supplier's compound buyer is free to take the better price. Overmolded parts double the problem — two materials, two additive packages, often two suppliers (overmolded TPU and PC construction). If the same SKU also ships to Europe, note that the EU asks a different question of the same silicone compound: D4, D5 and D6 siloxane restrictions.
Warning or no warning is a business decision
Compliance professionals call the safe-harbour warning a business decision because both answers are lawful. Nothing penalises a warning you did not strictly need. What punishes over-warning is the channel: some marketplace listings require a Prop 65 attribute at SKU level, and some retail programs treat a warned SKU as an exception requiring buyer sign-off rather than a routine listing. What punishes under-warning is the notice pipeline and its settlement economics — in a private action the money divides between a civil penalty and the plaintiff's attorney's fees, and the fee component is typically the larger half. Defence costs push most matters toward settlement regardless of merit. Budget against that, not against a maximum penalty you will never see litigated.
| Posture | What it costs you | What it buys | Where it bites |
|---|---|---|---|
| No warning, supported by compound disclosure, testing and a written exposure rationale | Lab spend per compound and colour; consultant time; a real specification lock with the factory | The cleanest retail and marketplace position, and a file that answers a notice on day one | Only as strong as the disclosure behind it; collapses the moment a compound changes without notice |
| Warning applied to the SKU, named chemical, correct format | Label artwork, packaging revision, channel friction, some conversion loss on consumer-facing listings | Removes the notice exposure for the named endpoint | You must name a chemical you have a basis to believe is present; the warning follows the SKU across every channel |
| Blanket warning across the catalogue with no testing | Cheapest up front | Very little that survives scrutiny | The 2018 warning-content rules require naming at least one listed chemical per endpoint, so a genuinely blind blanket warning is not really on offer; naming a chemical with no basis creates its own labelling and channel problems |
The middle row hides the operational trap. Since the 2018 regulations under Title 27 of the California Code of Regulations, a compliant warning generally carries a symbol, names at least one listed chemical for each endpoint being warned about, and points to the OEHHA warnings website. The short-form version used on small packages has been amended since, with phase-in dates. Confirm the currently permitted text and the applicable deadline with counsel before you release artwork, because labels printed to a superseded format are scrap, and on a molded case the warning often lands on a polybag insert or a printed colour box with a long lead time of its own.
Testing, and the purchase order language that moves the risk
What to ask the lab for
Scope the testing to the production compound, not to whatever the factory pulled off the shelf that week. Ask explicitly for heavy metals by acid digestion and ICP-MS on each colour of each compound; phthalate screening by GC-MS on every soft component, ink and label; residual monomer by headspace GC-MS where styrenics are present; a bisphenol screen where polycarbonate is present. Then ask the question that matters — will the lab write an exposure assessment, or only a content report? Many do only the latter, and only the former supports a no-warning position.
Insist retained samples are pulled from the pilot run and first production lot, sealed and dated, and held for a defined period. When a notice arrives eighteen months later, that sample is the only physical evidence of what you actually sold.
What to write into the purchase order
- Compliance representation. The goods, as delivered, comply with California Health & Safety Code §25249.5 et seq. and the implementing regulations in force at the shipment date, and no listed chemical is present above any adopted safe-harbour level for the intended use.
- Full material disclosure. A complete additive and pigment declaration with CAS numbers for every component, including inks, adhesives, labels and packaging in contact with the product.
- No-substitution clause. No change to compound, colour paste, masterbatch, additive package, resin grade or compound supplier without your prior written approval. This is the clause that does the most work and the one most often left out.
- Recycled content. Virgin resin unless recycled content is specifically approved in writing, with disclosure of the recyclate source.
- Testing and cost allocation. Who tests, at which accredited lab, on what trigger — pilot run, first production lot, any compound change, and at a defined interval thereafter — and who pays when a result fails.
- Evidence obligations. Certificate of analysis per lot; retained production samples held for a stated period; traceability from lot number to compound batch.
- Indemnity. Coverage extending to 60-day notices, defence costs, attorneys' fees, settlement amounts, recall and rework costs, and retailer chargebacks, with a survival period that outlives the last shipment by a comfortable margin.
The honest limit of an indemnity
An indemnity from an overseas supplier is worth what you can practically enforce. Cross-border collection on a US settlement is slow and expensive, so in practice the clause functions as a right of set-off. Pair it with commercial terms that leave a balance outstanding — a retention against the final payment, or an ongoing order book you can hold against — and it becomes real. Written into a purchase order paid in full on shipment, it is a paragraph. The wider documentation set belongs in what documents to ask a China supplier for before your first order; the market-by-market view is in the importing compliance checklist by market.
Common questions
Does a CE mark, an FDA food-contact statement or a food-grade silicone declaration cover Prop 65?
No. They are different regimes with different scopes and different chemical lists. A food-grade compound statement addresses food-contact suitability; Prop 65 addresses warning duties for listed chemicals at particular exposure levels in California. A part can satisfy one and still attract a notice under the other. The relationship between food-grade declarations and what they actually certify is covered in food-grade silicone, 21 CFR 177.2600 and LFGB explained, and market-entry marks generally in product certification for China exports, CE and FCC.
The factory says its silicone is food grade and its plastics are RoHS compliant. Is that enough?
It is a starting point, not a defence. RoHS addresses a defined substance set in electrical and electronic equipment at homogeneous-material level; Prop 65 covers a broader list and asks a different question. Neither tells you the pigment chemistry, the plasticiser in the printed logo, or whether the compound supplier changed last quarter. Ask for the underlying declarations.
Can I just accept the factory's existing test report?
Read it before you rely on it — lab, accreditation, report date, the exact sample described, and whether the scope covers your colour and your compound. A report on a black case from two years ago says nothing about the red one you are ordering now. Treat it as an input to your scoping decision, not as coverage.
What to ask the supplier next
Send these with the specification, before the proforma is signed, and file the answers with your own dated decision note.
- A full material declaration per component, with CAS numbers, covering compound, colour paste or masterbatch, additive package, ink, adhesive and label.
- The compound and pigment supplier names, and whether they are the same for every colour in the SKU range.
- Virgin or recycled resin? In writing, per material, with the recyclate source if any.
- The cure system for the silicone compound, and the post-cure step, if there is one.
- Existing test reports — lab, accreditation, date, exact product and colour scope. Ask for the PDF, not a summary line in a quotation.
- Change control. Will the factory accept a written no-substitution clause covering compound, colour and supplier, and who signs off on the factory side?
- Retained samples. Will they pull, seal and hold samples from the pilot run and first production lot, and for how long?
- Lot traceability. Can a finished-goods lot number be traced back to a compound batch?
WJM Silicone is a reasonable case to run this exercise against, because its material list is exactly the awkward one: food-grade silicone, industrial silicone rubber, TPU, PC and ABS, combined into overmolded constructions, with printing, surface treatment and assembly done in house — five polymer families and several additive packages inside a single part, before you count the ink. The factory page puts roughly 80% of output into the Americas and Europe, so the compound questions above have almost certainly been asked before — a reason to expect answers, not a reason to skip asking. On certificates, the CMH profile is explicit that numbers, validity and issuing bodies have not been verified and will only be published once originals are checked. Treat any certification named in a quotation as a document to request and read, not as a fact you have received.