Do I need a heavy metals report for each packaging in Europe?

Do I need to test every component? Can I add supplier declarations together? Does “<30 ppm” actually mean 30 ppm? And what evidence does the PPWR really require?

Since 12 August 2026 the questions arriving in packaging, regulatory and procurement inboxes have followed a pattern. A customer asks for a heavy metals report. Someone forwards it to the supplier. The supplier sends a declaration. Nobody is quite sure whether that settles anything.

Do we need a laboratory report for every packaging component?
We have 800 SKUs. Are we supposed to test all 800?
The bottle supplier says below 30 ppm and the closure supplier says below 30 ppm. Can I add them?
If a supplier writes “<30 ppm”, should I calculate with 30?
Can one representative test cover several variants?
Is a supplier declaration enough, or do I still need my own testing?

Underneath them sits an assumption worth examining: that Europe introduced a heavy metals requirement in August 2026. It did not. The limit those questions are about has been in European packaging law since 2001.

Start with the number

Article 5(4) of Regulation (EU) 2025/40 sets the rule in one sentence. Leaving aside its opening cross-references to chemicals and food-contact law, it reads: “the sum of the concentrations of lead, cadmium, mercury and hexavalent chromium resulting from substances present in packaging or packaging components shall not exceed 100 mg/kg.”

Three details in that sentence do most of the work. It is a sum, not four separate allowances. It is a concentration, expressed in milligrams per kilogram. And it attaches to packaging or packaging components, not only the final assembly.

The limit

One number, four metals, twenty-five years

Four metals are regulated: lead, cadmium, mercury and hexavalent chromium. Only chromium in its hexavalent oxidation state counts, which is why the speciation matters analytically and why a total chromium figure does not answer the question on its own.

They are not assessed separately. The Regulation adds their concentrations together and applies a single ceiling to the total.

That ceiling is 100 milligrams per kilogram, equivalent to 100 parts per million by mass. It is a combined figure. A pack is not entitled to 100 mg/kg of each metal.

The limit attaches to packaging or packaging components. That wording is deliberate, and it is why reducing the question to “only the finished pack matters” is too loose.

And the number itself is twenty-five years old. Directive 94/62/EC introduced a staged reduction, and the Commission’s own 2001 decision on glass packaging records that the 100 ppm level was due to enter into force on 30 June 2001.

A short history, because it explains the confusion

1994Directive 94/62/EC is adopted. Article 11 sets a staged reduction of the combined concentration of the four metals.
600 → 250 → 100The staging runs in parts per million by weight, at two, three and five years from the transposition date in Article 22.
30 June 2001The 100 ppm stage takes effect. Commission Decision 2001/171/EC refers to it as “due to enter into force on 30 June 2001”.
2001 and 2009Two narrow derogations are established: glass packaging, and plastic crates and pallets in closed and controlled loops.
11 Feb 2025Regulation (EU) 2025/40 enters into force.
12 Aug 2026The PPWR applies. The Commission’s FAQ confirms the Article 5(4) limits “apply to all packaging from 12 August 2026”.

The number is old. The architecture around it is not.

It would be wrong to say the old rule was optional because it sat in a Directive. Directives bind through national implementation, and the 100 ppm limit was law in every Member State. What has changed is the machinery around the number, and that machinery is genuinely new.

Directive 94/62/EC expressed the requirement as an obligation on Member States: “Member States shall ensure that the sum of concentration levels … shall not exceed”. The PPWR expresses it as a directly applicable prohibition and then bolts onto it a conformity architecture the Directive never had. Article 15 makes the manufacturer carry out a conformity assessment and draw up technical documentation. Article 38 points that assessment at Annex VII. Article 39 requires an EU declaration of conformity, and states that by drawing it up “the manufacturer assumes responsibility for the compliance of the packaging”. Article 16 obliges suppliers to hand over the information the manufacturer needs. That is why an old limit suddenly feels new.

So do I need to test everything?

Read the Regulation looking for the testing obligation and you will not find one. There is no provision requiring a laboratory report per SKU, per component or per batch. Searched end to end, the text of Regulation (EU) 2025/40 contains no reference to sampling, to a testing frequency, to a laboratory test, or to a prescribed analytical method for Article 5(4).

What it contains instead is Article 5(6): “Compliance with the requirements set out in paragraphs 4 and 5 of this Article shall be demonstrated in the technical documentation drawn up in accordance with Annex VII.”

The obligation is documentary. It is an obligation to be able to show why the packaging complies. Annex VII then describes what that documentation has to do: “The documentation shall make it possible to assess the packaging’s conformity with the applicable requirements, and shall include an adequate analysis and assessment of the risks of non-conformity.” The list of contents that follows applies “wherever applicable”, and its final item is “test reports”.

Test reports can be therefore an element of the file, not the definition of compliance. The load-bearing phrase is the one about analysing and assessing the risks of non-conformity. A manufacturer who has done that seriously will know where testing adds evidence and where it merely adds paper.

The four declarations problem

Here is the situation that generates most of the confusion. It is fictional, but the arithmetic in it is real.

Worked example

Four components, four declarations, one wrong answer

A filler assembles a pack from four supplied components. Each supplier certifies the same thing: the sum of lead, cadmium, mercury and hexavalent chromium is below 30 mg/kg. Note that this is the sum of the four metals, not 30 mg/kg of each.

The intuitive move is to add the declarations. Four components at 30 gives 120, which is over the limit, and the packaging team starts booking laboratory slots.

The arithmetic is wrong. Parts per million is a ratio: milligrams of metal per kilogram of material. Adding four ratios together answers no meaningful question, in the same way that combining two glasses of water at twenty degrees does not give you forty degrees.

A pack is rarely one material. The body may be one plastic, the sticker paper, the closure another polymer again. These are different materials in nature, and they are present in very different amounts.

Run it and the result is unremarkable. If every component sits below 30 mg/kg and assembly introduces nothing new, the weighted average can also be below 30 mg/kg. A weighted average of values that are each under a bound cannot exceed that bound.

What “<30 ppm” is actually telling you

The arithmetic above is the easy half. The harder half is that “<30 mg/kg” is not a measurement. It is an upper bound, and an upper bound is only as meaningful as the method behind it.

Behind that figure the true value might be 29 mg/kg, or 8, or 0.4, or genuinely undetectable. The statement might reflect a measured result, or a limit of quantification, or a reporting limit the supplier applies as house policy, or a calculation from raw material data with no measurement at all. Those are very different pieces of evidence wearing the same clothes.

Reading a declaration

Seven questions to ask of any number

Sum or each?

Does the figure cover the sum of the four metals, or does it state a value per metal? These are different claims and only one of them maps onto Article 5(4).

Measured or derived?

Was anything analysed, or is the figure calculated from input specifications? Both can be legitimate evidence.

Which chromium?

The limit concerns hexavalent chromium. A total chromium result overstates what the Regulation restricts and needs interpretation, not direct comparison.

What is the reporting limit?

A “less than” value sits on top of a limit of quantification or a reporting threshold. Without it, the number has no floor.

What was sampled?

A pigmented masterbatch, a finished component, a specific colourway. Representativeness decides whether the result can be extrapolated.

Which grade and site?

Material grade, production location and feedstock route can all move the answer. A declaration covering one grade does not automatically cover its siblings.

Valid for how long?

Is it tied to a batch, a period, a specification version, or nothing at all?

The second trap: “each metal is below 30”

A supplier writes that lead is below 30, cadmium below 30, mercury below 30 and hexavalent chromium below 30. Comfortably inside 100, surely.

Not necessarily. Four separate upper bounds of 30 permit a sum of up to 120 in the worst case, which is above the limit. In practice such a declaration usually reflects four independent reporting limits rather than four near-threshold results, and the true sum is likely far below. But the declaration as written does not establish that. It certifies four things individually, while Article 5(4) asks one question about their total.

This is the clearest illustration of why compliance is not document collection. Two declarations can look almost identical and support entirely different conclusions.

“We tested it once. Can we rely on that forever?”

A test report describes a defined sample under defined conditions. Its continuing value depends on whether those conditions still describe what you place on the market, and here the Regulation is unusually direct.

Article 15(4) requires manufacturers to have procedures for series production to stay in conformity, to take account of changes in packaging design or characteristics, and, where they find that conformity could be affected, to carry out a re-assessment. Change control is not merely good practice here. It is drafted into the manufacturer’s obligations.

So the question is not how old the report is. It is whether the supplier, formulation, pigment, coating, recycled content, process or production site has moved since it was taken.

Where recycled content fits, carefully

Nothing in the Regulation treats recycled content as presumptively non-compliant, and the historical derogations point the other way: both the glass decision and the plastic crates decision exist precisely because recycled feedstock can carry legacy metals from material placed on the market decades ago.

The useful distinction is variability, not virtue. A well-sorted, industrial packaging waste with a known input, a stable specification and a qualified supplier presents a different evidential picture from a heterogeneous, co-mingled post-consumer stream whose composition shifts with collection. Neither is a legal category. Both are inputs to the risk analysis Annex VII asks for. Thus, compliance architecture is built on risk.

Sidebar

There are exceptions, but they are specific

Two derogations from the 100 mg/kg limit survive the move to the PPWR. Commission Decision 2001/171/EC covers glass packaging, and Commission Decision 2009/292/EC covers plastic crates and plastic pallets circulating in closed and controlled loops. The Regulation provides that both remain in force and continue to apply until repealed by delegated acts adopted under Article 5(8), and the Commission’s FAQ states plainly that Decision 2001/171/EC “continues to apply and has not been repealed by the PPWR”.

Both are narrow. The glass derogation permits an exceedance only where it results from adding recycled glass, and requires that none of the four metals is intentionally introduced during manufacturing. The plastic crates derogation depends on a controlled recycling process fed essentially from other crates and pallets. Neither is a general allowance for recycled content.

One point to watch: Directive 94/62/EC contained a separate exemption in Article 11(2) for packaging made entirely of lead crystal glass. No equivalent wording appears in Article 5 of the PPWR. Anyone relying on that exemption should take advice rather than assume it carried across.

What a defensible position looks like

Putting the pieces together gives something more useful than a testing policy. The manufacturer signs the declaration or statement, so the manufacturer needs a chain of reasoning that holds.

The evidence chain

Compliance is a system, not a folder

Suppliers provide information. Article 16 obliges them to give the manufacturer what is needed to demonstrate conformity. The Commission’s FAQ describes this as the input manufacturers need from material suppliers and converters.

The manufacturer turns that into knowledge of the pack: bill of materials, grades, pigments, coatings, adhesives, inks and the processes that join them. You cannot assess a risk in a material you have not characterised.

Then the step Annex VII actually names: an adequate analysis and assessment of the risks of non-conformity. Where could these four metals plausibly originate, and how stable is the evidence that they do not?

Verification follows the risk rather than the calendar. Testing is most valuable where uncertainty is highest: an unfamiliar pigment, a new supplier, a variable feedstock, a result near the threshold.

All of it lands in the technical documentation, which is where Article 5(6) says compliance is demonstrated. The file should explain the reasoning, not merely store the attachments.

And then someone signs. Article 39(4) is explicit that by drawing up the declaration the manufacturer assumes responsibility for compliance. The Commission’s FAQ puts it more bluntly still: the manufacturer is the sole economic operator bearing legal responsibility.

That last point is where supply chain architecture matters. Information flows downstream from suppliers under Article 16. Legal responsibility does not flow with it. A supplier declaration is an input to the manufacturer’s assessment, not a transfer of the manufacturer’s obligation, and no amount of forwarding changes who signs.

When testing genuinely earns its place

None of this is an argument for testing less. It is an argument for knowing what a given test is supposed to establish. Analytical work is most defensible where the evidence base is poor or the risk is concentrated.

Illustrative only

Where verification tends to earn its keep

Evidence situation	Relative verification need
Stable virgin material, detailed specification, long history	Lower
Qualified recycled input from a controlled source	Low to medium
New supplier, or incomplete supporting information	Medium
Highly variable or poorly characterised recycled input	Higher
Pigment, ink or additive of uncertain metal content	Higher
Previous result close to the threshold	High
Previous non-conformity, or a complaint	High

Illustrative compliance-risk framework. Not a classification established by the PPWR. The Regulation defines no risk classes, no testing frequency and no analytical method for Article 5(4). This table is one way of organising the judgement Annex VII asks a manufacturer to make and to record.

A note on method, since it is a common gap. The PPWR prescribes no analytical procedure for the four metals, and no harmonised standard currently confers a presumption of conformity for Article 5(4). The CEN document most often reached for is CEN/CR 13695-1:2000, which is a CEN Report rather than a harmonised European Standard: it was developed under the Directive and offers guidance on measuring and verifying the four metals, but it does not carry the legal effect that a harmonised standard would. In practice the questions that decide the quality of a result are the ordinary ones of analytical chemistry: how the sample was taken and prepared, what digestion or extraction was used, whether hexavalent chromium was determined by speciation rather than inferred from total chromium, what the limits of detection and quantification were, and what uncertainty attaches to the figure.

The 100 mg/kg limit did not arrive with the PPWR. It has been part of European packaging law since June 2001, and most packaging placed on the EU market has complied with it, quietly and without a certificate, for a quarter of a century.

What arrived in August 2026 is the requirement to be able to show your reasoning. Article 5(6) asks for demonstration in the technical documentation. Annex VII asks for an analysis of where non-conformity could come from. Article 39 asks for a signature.

None of those ask for a laboratory report per SKU. They ask for something harder and considerably more useful: knowing what you make, what goes into it, where the uncertainty sits, and why the evidence you hold is representative of what leaves your site.

Before ordering another test report, be clear about which question it is meant to answer.

References

Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, Articles 5, 15, 16, 17, 38 and 39, recitals 25 to 27, Annex VII and Annex VIII. EUR-Lex
Directive 94/62/EC of 20 December 1994 on packaging and packaging waste, Article 11, concentration levels of heavy metals present in packaging. EUR-Lex
Commission Decision 2001/171/EC of 19 February 2001 establishing the conditions for a derogation for glass packaging in relation to the heavy metal concentration levels established in Directive 94/62/EC. EUR-Lex
Commission Decision 2009/292/EC of 24 March 2009 establishing the conditions for a derogation for plastic crates and plastic pallets in relation to the heavy metal concentration levels established in Directive 94/62/EC. EUR-Lex
European Commission, Directorate-General for Environment, Packaging and Packaging Waste Regulation (PPWR): Frequently Asked Questions, Publications Office of the European Union, 2026, in particular the questions on substances of concern, the heavy metal limits in Article 5(4), the glass derogation and the obligations of manufacturers and suppliers.
European Commission, Annex to the Communication to the Commission, draft Commission Notice on the Guidance document for Regulation (EU) 2025/40, C(2026) 2151 final, 30 March 2026. Consulted for the conformity architecture and the manufacturer role; it does not address the heavy metal limits.
CEN/CR 13695-1:2000, Packaging. Requirements for measuring and verifying the four heavy metals and other dangerous substances present in packaging, and their release into the environment. Part 1. A CEN Report developed under Directive 94/62/EC, not a harmonised standard.

This article reflects independent professional analysis and is provided for informational purposes. It is not legal advice, and it is not an official position of the European Commission or of any other institution or organisation. Commission guidance documents and FAQs are interpretative and do not alter the Regulation; binding interpretation of Union law rests with the Court of Justice of the European Union. The compliance approach described here is analysis rather than a procedure prescribed by the PPWR. Verify against the primary texts and take advice on your own packaging before making compliance decisions. Last reviewed August 2026.