The CPSIA and EN 71-3 Double Track for Children's Product Packaging: Who Should Issue the Ink Heavy-Metal Report?

One year, just before Christmas, a customer exporting educational building blocks called me late at night. His US importer had rejected his CPC, because the printed carton was not covered by the testing scope of the children's product certificate. He did not understand: the box is not a toy, and no child chews on the box.

That sentence — no child chews on the box — is exactly the point of disagreement. The USA and the EU answer it differently, and most disputes happen in that gap.

The US track: the packaging may itself be a children's product

CPSIA governs products intended for children aged 12 and under. Its core requirements are total lead content and phthalates, plus the referenced toy safety standard. Whether packaging must be tested is decided in practice by three things: whether the packaging continues to exist after the child receives the product, whether it will be played with as part of the product, and whether it carries a functional role.

A pure shipping carton that is discarded on opening is normally out of scope. But a gift box with a handle, cartoon artwork, internal compartments and a design that clearly invites the child to store the blocks in it will almost certainly be pulled into the CPC by the importer's compliance team. My customer failed exactly there: his box carried a printed put them back storage prompt, which effectively declared the box part of the product's use cycle.

The test object is the harder part. CPSIA lead is total content, not migration, measured on the material itself, and it must be broken down by material and by colour — the red ink and the gold foil on the same box are two separate samples. Many printers hand the customer a heavy-metal report on the paper, which is nearly useless in the USA because it does not cover inks or surface finishes.

The EU track: first decide whether it is part of the toy

The EU logic differs. EN 71-3 covers migration of 19 elements, simulating dissolution in saliva, and it applies to toys and accessible toy parts. So the first step is not testing but classification: is this packaging part of the toy under toy safety legislation?

The usual yardstick is whether the packaging has play value and whether it is designed to be retained during play. A puzzle box that doubles as a puzzle base or storage tray is part of the toy; a pure outer box generally is not. But note that even when it is not a toy, packaging remains subject to EU packaging waste rules, which set a combined 100 ppm limit for four heavy metals (lead, cadmium, mercury, hexavalent chromium). That requirement applies to all packaging regardless of whether it is a children's product.

This is exactly the point most printers cannot articulate. The EU does have a heavy-metal line, it simply comes from packaging legislation rather than toy standards, and the limit is expressed differently (total content rather than migration). When a customer asks whether your box meets EU children's packaging requirements, the right answer starts with a question: in your technical file, is this box classified as a toy part or as packaging? The two answers call for entirely different reports.

Who issues the report: a workable division of responsibility

Legally the responsible party is whoever places the product on the market — the importer or domestic manufacturer in the USA, the manufacturer or authorised representative in the EU. The printer is not the responsible party, but the printer is the only one who knows the truth about the materials, so a customary division has emerged.

The printer should provide material-level evidence of compliance: declarations for the paper, inks, coatings, foils and laminates used, plus third-party test reports carried out on the actual printed product. The brand owner or importer issues the product-level certificate — the CPC or EU declaration of conformity — citing the packaging reports as supporting documents.

Disputes most often arise when a printer simply forwards the ink supplier's declaration. That declaration states that the ink complies under recommended conditions; it says nothing about the result after hot foil stamping, lamination and a layer of spot UV. A customer making gift boxes for children's picture books lost two weeks over precisely this. She later put it in a sentence I now use with new customers: what they want is not proof that you used a compliant ink, but proof that the sheet you printed is compliant.

Sampling details: three ways to waste money

The first trap is sample form. Total lead testing requires actual production printed pieces, not blank paper and not digital proofs — digital proofing inks differ entirely from production offset inks, and such a report will be considered unrepresentative. Take samples from the production first-off and retain a matching batch sample.

The second trap is colour separation. If the report simply says carton, the laboratory tests a composite sample and the customer's compliance team will most likely demand a retest. Tell the laboratory in advance to list the main colour, dark areas, metallic areas and any separate inks (such as fluorescent spot colours) as distinct samples. Dark and metallic colours have historically caused the most failures.

The third trap is validity and change control. Reports usually carry no statutory expiry, but customer systems typically require annual renewal, or retesting when materials, suppliers or processes change. Switching ink supplier, changing gloss lamination to matt, or adding spot UV all trigger retesting under many brand rules. So the printer needs one very plain internal document: which materials each item number uses, which reports cover them, and when they were last tested. That table is worth more than any system manual.

Further reading

Three Gates for Packaging Exported to the USA: What FDA, Prop 65 and CPSIA Each Cover
Four EU Compliance Requirements for Cosmetic Packaging: REACH, EC 1223/2009, 94/62/EC and EN 13427
The Real Bill for Food Packaging Safety Testing: Migration, Microbiology and Heavy Metals
A Customer Demands BRCGS Certification: Three Real Thresholds for Small Printers