The 100 mg/kg Heavy Metals Limit: Lab Test or Supplier Declaration?
PPWR Article 5(4) caps lead, cadmium, mercury and chromium VI at 100 mg/kg combined. When a supplier declaration is enough, and when you need a lab test.
A Limit Old Enough to Rent a Car
The 100 mg/kg heavy metals limit in the PPWR turns 25 next year. Article 5(4) of Regulation (EU) 2025/40 caps the combined concentration of lead, cadmium, mercury and hexavalent chromium in packaging or packaging components at 100 mg/kg. The same number has applied across the EU since 30 June 2001, under Article 11 of Directive 94/62/EC. It phased in over five years: 600 mg/kg from mid-1998, 250 mg/kg from mid-1999, 100 mg/kg from mid-2001. Then it sat there, unchanged, through six Commission presidents.
So the substance rule is not news. Packaging that was compliant on August 11, 2026 is compliant on August 12, 2026. What changes is the paperwork. Article 5(6) of the PPWR requires you to demonstrate compliance in the technical documentation behind your Declaration of Conformity. Under the old directive, most companies never wrote anything down. Enforcement was thin, and "we assume our boxes are fine" functioned, in practice, as a compliance position. From August 12, 2026 it does not. You need evidence in a file.
Which raises the only question that costs money: what counts as evidence, and when do you have to pay a laboratory for it?
What Article 5(4) Actually Says
Four metals, one number. The sum of lead (Pb), cadmium (Cd), mercury (Hg) and hexavalent chromium (Cr VI) present in packaging or packaging components must not exceed 100 mg/kg. That is 100 parts per million, or 0.01% by weight.
Three details do the real work:
- It is a sum, not four separate limits. 60 mg/kg of lead plus 50 mg/kg of cadmium is 110 mg/kg. Fail.
- It applies per packaging component. The box, the label, the tape, the closure: each counts.
- It covers all packaging. The PFAS restriction in the same article is scoped to food-contact packaging. The heavy metals limit is not. Shipping cartons, mailers, pallet wrap, blister packs: all in scope, every sector.
Mercury earns its place on the list mostly for historical completeness. Nobody has deliberately put mercury in a shipping carton in living memory. The limit stays, in case someone gets ideas.
Where the Metals Actually Hide
Heavy metals do not wander into packaging at random. They arrive through a short list of known doors:
| Source | Metals involved | Where the risk sits today |
|---|---|---|
| Pigments in plastics | Lead (chromate yellows, oranges), cadmium (reds) | Restricted in EU manufacture for years; still surfaces in imported colored plastics |
| Printing inks | Lead, chromium | Legacy pigments; mostly gone from EU ink systems, watch imported pre-printed packaging |
| PVC stabilizers | Lead, cadmium | Phased out of EU-made PVC; non-EU PVC film and closures remain a question mark |
| Recycled input | All four | Recyclate inherits whatever was in the old material, including 1980s cadmium pigments |
| Colored glass | Lead, chromium | Recycled cullet carries traces; this is what the glass derogation exists for |
| Metal components | Chromium VI | Chromate passivation layers on some metal parts and closures |
The pattern is consistent. Virgin, uncolored, EU-produced mainstream materials (kraft paper, corrugated board, clear PE and PP film, standard glass) essentially never approach 100 mg/kg. The risk concentrates in three places: color, recycled input, and imports. If your packaging has none of the three, your exposure is low. If it has all three, keep reading.
The Test, If You Need One
The lab workflow is settled. Screening runs on X-ray fluorescence (XRF), which is fast and needs no sample destruction. Confirmation runs on acid digestion followed by ICP-MS or ICP-OES.
Chromium adds one wrinkle. The limit covers hexavalent chromium, not total chromium, and speciating Cr VI in a solid matrix is genuinely annoying. Labs solve this the sensible way: measure total chromium first. If total chromium plus the other three metals stays under 100 mg/kg, no possible chromium VI fraction can breach the limit, and nobody has to speciate anything. Chemistry has its shortcuts too.
On cost: Measurlabs, an accredited-lab marketplace, lists heavy metal content testing against Directive 94/62/EC and the PPWR at EUR 158 to 198 per sample, plus a EUR 97 service fee per order, with a 50 g sample and 3 to 4 weeks turnaround. Quantification limits sit at 2 mg/kg for lead and total chromium and 0.5 mg/kg for cadmium and mercury, comfortably below the threshold. Other labs will quote differently by country and volume: ask your lab for a quote before budgeting. The regulation sets the number, not the method, so any accredited lab's standard packaging heavy-metals package will do the job.
Roughly EUR 250 for one sample, all in. Hold that figure while we discuss when you can skip it.
When a Supplier Declaration Is Enough
For most sellers, most of the time. The economics are straightforward: your converter or packaging supplier is the party who actually knows the masterbatch recipe, the ink system, and the recyclate source. They test once, or hold their raw-material suppliers' data, and issue declarations across their whole customer base. You file the declaration. This is the system working as designed.
A supplier declaration reasonably carries the file when all three hold:
- The material is a standard grade from an established EU or otherwise credible converter.
- The declaration is written, specific, and current.
- Nothing about the packaging sits in the risk table above.
The catch is point 2. A usable declaration:
- Identifies the exact item or material grade. SKU, spec number, or material designation. "Our products" identifies nothing.
- Cites the rule with the number. Sum of Pb, Cd, Hg and Cr VI below 100 mg/kg per Article 5(4) of Regulation (EU) 2025/40. A reference to Directive 94/62/EC does the same technical work, since the limit is identical; ask for updated wording anyway.
- Covers components. Inks, coatings, labels and closures included, stated explicitly.
- Is dated and signed by a named person with a function, not an info@ address.
- References the evidence behind it. Test method, lab, test date. Best suppliers attach the report.
"Our products comply with all applicable EU regulations," on unheaded paper, undated: that is not a declaration, that is a mood. It will not survive first contact with a market surveillance authority, and it should not go in your technical file.
When to Commission Your Own Test
Three situations flip the default:
Own-brand direct imports. If you buy packaging, or packaged product, directly from a non-EU manufacturer and place it on the EU market under your brand, the compliance obligations land on you, not the factory. A factory that responds to a documentation request with "which certificate do you need? we send today" is telling you something about how the certificate gets made. Test the packaging. Once, per material, on arrival of the first production batch.
Recycled content. Recyclate inherits the past, and the input stream changes batch to batch. A supplier declaration issued in January describes January's cullet or January's flake. Ask the supplier how incoming material is controlled and how often they retest. A concrete answer with data: declaration suffices. A vague answer: commission your own test, and consider repeating it annually.
Heavily pigmented plastics, colored glass, and anything PVC. This is where the historical chemistry actually lives. Bright yellow, orange and red plastics deserve particular skepticism, since lead chromate and cadmium pigments produced exactly those colors cheaply for decades.
One test covers one material specification. So the sensible program for a small seller is not "test everything." It is: test the one or two highest-risk items, collect proper declarations for the boring brown boxes.
The Derogations (Probably Not for You)
Two derogations from the old directive survive into the PPWR era. Recitals 25 and 26 of Regulation (EU) 2025/40 state that both are maintained:
- Glass packaging (Commission Decision 2001/171/EC). Glass may exceed the limit where the exceedance results solely from recycled cullet and no listed metal was intentionally introduced in manufacturing. Monitoring conditions attach, and under the Decision, average concentrations above 200 mg/kg trigger reporting obligations to the authorities.
- Plastic crates and pallets in closed loops (Commission Decision 2009/292/EC). Crates and pallets made with recycled material, circulating in closed and controlled loops, get relief under marking, inventory and tracking conditions.
If you bottle in green glass or operate a pallet pool, these two Decisions are load-bearing. If you ship parcels, they are trivia.
What Goes in the File
Per packaging item: material specification, supplier declaration or test report, date. That set feeds the technical documentation behind your Declaration of Conformity under Article 5(6). The heavy metals row will usually be the least dramatic line in the whole file. It has been the law since 2001; your supplier has probably been quietly compliant the entire time. The August 2026 change is that "probably" stops being a filing.
Complydex's wizard builds the Declaration of Conformity and tells you which evidence you still owe for each packaging item, heavy metals included. Start with your company profile and see where your gaps are before a market surveillance authority does.