Regulations

PPWR Article 5: PFAS limits and heavy metals in packaging

Since 12 August 2026 three substance obligations apply to packaging: minimise substances of concern, keep four heavy metals under 100 mg/kg, and stay below the PFAS limits in food-contact packaging. What applies, how it is measured and what belongs in the technical documentation.

Author: myDPP Team

PPWR Article 5: PFAS limits and heavy metals in packaging

Most requirements in the Packaging and Packaging Waste Regulation (EU) 2025/40 bite in 2028, 2030 or 2035. Article 5 does not. It has applied in full since 12 August 2026 — no transition period, no pending implementing act, no threshold that lets smaller companies out. Anyone placing packaging on the EU market today must be able to show today that it meets the substance requirements.

This is routinely underestimated, because Article 5 looks unremarkable from the outside: a duty to minimise, a heavy-metal limit inherited from the old Packaging Directive, and a PFAS rule for food packaging. In practice it is the article that ties packaging to chemicals law for the first time — and the reason your suppliers’ substance data suddenly becomes a document you have to hold. That same data is the core of any digital product passport.


Key takeaways

  • Article 5 has applied in full since 12 August 2026. There is no sell-through period for stock already produced and no micro-enterprise exemption. The three-year stock rule covers labelling under Article 12, not the substance requirements.
  • Three obligations, one article: minimise substances of concern in all packaging (paragraph 1); the sum of lead, cadmium, mercury and hexavalent chromium must not exceed 100 mg/kg in all packaging (paragraph 4); PFAS limits apply to food-contact packaging only (paragraph 5).
  • The PFAS rule is not a ban but a set of concentration limits — three of them: 25 ppb for any individual PFAS, 250 ppb for the sum (both by targeted analysis, polymeric PFAS excluded from quantification) and 50 ppm for PFAS including polymeric PFAS.
  • It covers intentionally added and unintentionally present PFAS alike. The Commission will not publish a list of the PFAS concerned with CAS numbers; the structural definition in Article 5(5) is what counts.
  • Above 50 mg/kg total fluorine a supply-chain duty is triggered. The manufacturer, importer or downstream user as defined in REACH must, on request, provide proof of how much of the fluorine is PFAS and how much is not.
  • The limits apply to the packaging unit as a whole — including inks, varnishes, coatings, glues, adhesives and recycled content. A test report covering only the substrate does not carry the claim.
  • Two old derogations survive: the glass derogation under Decision 2001/171/EC and the derogation for plastic crates and pallets in closed and controlled loops under Decision 2009/292/EC. Both require that no heavy metal was intentionally introduced.
  • EN 13428:2004 no longer carries. Annex C of the standard has created no presumption of conformity for the substance requirements since 12 August 2026.
  • Proof belongs in the technical documentation under Annex VII (Article 5(6)) — the same file the PPWR declaration of conformity is built on.

Three obligations in one article

Article 5 is headed “Requirements for substances in packaging” and bundles three rules with different reach. Confuse them and you either test far too much or miss the part that matters.

Paragraph 1 — minimisation, all packaging. Packaging must be manufactured so that the presence and concentration of substances of concern as constituents of the packaging material or of any packaging component is minimised. Emissions and waste-management outcomes are expressly included — secondary raw materials, ashes, material for final disposal — as is the adverse environmental impact of microplastics. No number is attached: minimisation is a duty of conduct, not a threshold.

Paragraph 4 — heavy metals, all packaging. The sum of the concentrations of lead, cadmium, mercury and hexavalent chromium must not exceed 100 mg/kg, regardless of material, format or use.

Paragraph 5 — PFAS, food-contact packaging only. Since 12 August 2026, food-contact packaging may not be placed on the market if it contains PFAS at or above the three limit values.

The remaining paragraphs govern the machinery: paragraph 2 obliges the Commission to monitor and to report, paragraph 3 gives Member States a right to request restrictions, paragraph 6 points to the technical documentation, paragraphs 7 and 8 cover delegated acts, and paragraph 9 sets an evaluation.

What a “substance of concern” is — and why there is no list

The PPWR does not define the term itself. It borrows the definition from the Ecodesign for Sustainable Products Regulation, Article 2(27). The decisive point: the criteria are not cumulative. One is enough.

A substance is of concern if it

  • meets the criteria in Article 57 REACH and is identified under Article 59(1) — the SVHC candidate list,
  • is classified in Part 3 of Annex VI to the CLP Regulation in certain hazard classes — carcinogenicity, germ cell mutagenicity, reproductive toxicity, endocrine disruption for human health or the environment, PBT/vPvB, PMT/vPvM, respiratory or skin sensitisation, hazardous to the aquatic environment or to the ozone layer, specific target organ toxicity,
  • is regulated under the POPs Regulation (EU) 2019/1021, or
  • negatively affects the reuse and recycling of the materials in which it is present.

The fourth criterion is the unfamiliar one. A substance can be toxicologically unremarkable and still count, because it disrupts a sorting or recycling stream. What exactly falls under it is not settled — the Commission and the European Chemicals Agency are running a study to identify it.

There is no official list of substances of concern in packaging, and the Commission is explicit that no definite number exists. In practice manufacturers work from the available sources: ECHA’s SVHC candidate list, Annex VI to CLP, and the annexes to the POPs Regulation. Anyone already filing SCIP notifications has done part of the work.

The 100 mg/kg limit on four heavy metals

The value is not new. It comes from Article 11 of Packaging Directive 94/62/EC and was carried into the PPWR unchanged — deliberately, as recital 25 puts it: existing restrictions should be maintained for reasons of consistency.

Three details decide whether a test is worth anything.

It is a sum, not an individual value. What is measured is the sum of lead, cadmium, mercury and hexavalent chromium. Four individual results of 30 mg/kg each breach the limit even though no single figure looks alarming.

It is hexavalent chromium, not total chromium. An analysis of total chromium does not answer the question. Commission it and you get a number that is too high and a report that proves nothing.

The limit attaches to the packaging or the packaging component. Inks, varnishes, coatings, adhesives and labels are components. Pigments are the classic source of failure: chromate yellows and reds, cadmium pigments in plastics, legacy lead stabilisers carried in recycled material.

The limit applies “without prejudice” to the restrictions in Annex XVII to REACH and, where applicable, to the food-contact rules in Regulation (EC) No 1935/2004. Where those are stricter, the stricter value governs.

The two derogations that survived

Two Commission Decisions adopted under the old Directive set out conditions for derogating from the 100 mg/kg limit. Both continue to apply under the PPWR — recital 26 says so, and the Commission has confirmed it.

Decision 2001/171/EC — glass packaging. Glass may exceed the limit where the exceedance results from the addition of recycled glass. Cullet carries heavy metals from historic material in the loop that cannot be filtered out. The condition: no lead, cadmium, mercury or hexavalent chromium may be intentionally introduced during manufacture — and that has to be evidenced.

Decision 2009/292/EC — plastic crates and pallets. A separate derogation covers crates and pallets in closed and controlled product loops, again conditional on no intentional introduction and tied to marking and reporting requirements.

What the Commission may change about these is tightly bounded. Under paragraph 7 it may amend the sum by delegated act only to lower it, never to raise it. Under paragraph 8 it may set the conditions under which the sum does not apply to recycled materials or to closed and controlled loops — but such delegated acts may only amend the derogations already established in Decisions 2001/171/EC and 2009/292/EC. The Commission has no power to postpone the application date of the heavy-metal restrictions.

PFAS in food-contact packaging: three limits, not a ban

The shorthand “PFAS ban” is inaccurate. The PPWR does not ban PFAS; it sets maximum concentrations. Since 12 August 2026, food-contact packaging may not be placed on the market if it reaches or exceeds any of these:

LimitApplies toMeasurement
25 ppb (25 µg/kg)any individual PFAStargeted PFAS analysis, polymeric PFAS excluded from quantification
250 ppb (250 µg/kg)the sum of PFASsum of targeted analysis, where applicable after prior degradation of precursors, polymeric PFAS excluded
50 ppm (50 mg/kg)PFAS including polymeric PFASsee the total fluorine route below

Four points that summaries routinely drop:

The rule does not distinguish intentional from unintentional. Never having used PFAS does not make you compliant by default — contamination through recycled content, processing aids or equipment counts. That said, preliminary Commission laboratory work on selected packaging suggests that in practice only packaging with intentionally added PFAS exceeds the limits.

There will be no substance list. The Commission has decided not to publish a list with CAS numbers. What governs is the structural definition in Article 5(5): a PFAS is any substance containing at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom with no H, Cl, Br or I attached, subject to a narrow carve-out for specific structural elements. That is the broad, OECD-aligned definition, not a shortlist of known problem chemicals.

The rule is subsidiary. Its wording excludes cases where placing packaging with such a PFAS concentration on the market is already prohibited under another Union act. Where REACH or food-contact law bites harder, that prohibition governs.

The rule is under review. By 12 August 2030 the Commission must evaluate whether paragraph 5 needs amending or repealing to avoid overlaps with restrictions under Regulation (EC) No 1935/2004, REACH or the POPs Regulation. Until then it stands unchanged.

How it is measured: the total fluorine route

There is no harmonised EU test method for PFAS in food-contact packaging yet. The Commission is working with Member States, industry and the EU Reference Laboratory for Food Contact Materials on an agreed testing protocol; until it lands, enforcement relies on the pragmatic route the Regulation itself implies.

The usual sequence has three steps:

  1. Total fluorine screening, typically by combustion ion chromatography. Below 50 mg/kg the matter is normally closed — arithmetically there cannot be a PFAS content above the limits.
  2. Separating organic from inorganic fluorine. Above the screening threshold, the question is whether the fluorine comes from organic compounds at all. Inorganic fluorides, for instance from fillers or pigments, are not PFAS.
  3. Targeted analysis. Only now are individual PFAS and their sum quantified — the step that answers the 25 ppb and 250 ppb values.

The Regulation attaches a supply-chain duty to the first step. Where total fluorine exceeds 50 mg/kg, the manufacturer, importer or downstream user as defined in Article 3, points (9), (11) and (13) of REACH must, on request, provide proof of the quantity of fluorine attributable to PFAS versus non-PFAS, so that the packaging manufacturer or importer can draw up the technical documentation under Annex VII. That request right is the lever for pulling upstream suppliers into the process.

Heavy metals are simpler: digestion plus elemental analysis, with a separate determination of chromium(VI). Established methods exist.

What the limits attach to: the packaging unit

The most common misreading concerns not the number but the reference point. The Commission has answered it plainly: the limits apply to the packaging unit as a whole, including the associated inks, varnishes, glues and adhesives placed on the market by the manufacturer.

That has an uncomfortable consequence for procurement. A test report from the board supplier covering the raw carton does not demonstrate conformity of the finished folding box. Missing from it: printing ink, varnish, laminating film, window film, adhesive, hot-melt, label, tear strip. On grease-resistant coated papers — baking paper, burger wraps, popcorn bags, muffin cases — the PFAS risk sits precisely in the coating.

In practice the assessment starts from the bill of materials of the packaging, not from the main material. Each layer and component needs either a supplier declaration that genuinely references the PPWR requirements or a test of its own. Supplier obligations are in Article 16: they must provide the manufacturer with all information and documentation needed to demonstrate conformity, on paper or electronically.

The trap: EN 13428 no longer carries

If you documented packaging conformity over the past years, you almost certainly leaned on harmonised standard EN 13428:2004. Annex C of that standard deals with minimising dangerous substances and created a presumption of conformity under the old Directive.

Since 12 August 2026 it no longer does. The Commission’s reasoning: the standard focuses on dangerous substances in emissions and disposal, whereas Article 5 addresses the whole life cycle and explicitly ties the requirement to reuse, recycling and chemical safety. The expanded hazard scope — SVHCs under REACH, CLP hazard classes, recycling impacts — is not reflected in the standard.

Rolling forward an old conformity file without checking this point leaves you holding documentation that formally rests on a presumption that no longer exists. It is the most likely silent defect in existing packaging files.

What Article 5 does not do

Article 5 is not a complete chemicals code for packaging. Four regimes run alongside it and are expressly not displaced.

REACH, Annex XVII. Restrictions on substances in articles apply unchanged, and paragraph 4 names them as taking precedence. A broad, cross-sector PFAS restriction is being negotiated separately under the REACH process; it is independent of the PPWR rule.

Food-contact law. Regulation (EC) No 1935/2004 and its implementing acts, such as the plastics Regulation (EU) No 10/2011, remain decisive. The Commission is clear that the PPWR PFAS limits will not be transposed into those vertical acts.

Bisphenol A. BPA has its own instrument: Regulation (EU) 2024/3190, in force since 20 January 2025, with a general 18-month transition and longer periods for certain coated packaging. BPA does not fall under Article 5(5) — if you fold both topics into one test plan, keep the deadlines apart.

POPs and SCIP. Regulation (EU) 2019/1021 applies in its own right, and SVHC notifications to the SCIP database follow the Waste Framework Directive. Both create data needs that overlap with Article 5 without matching it.

The dates inside Article 5

DateWhat happens
31 December 2025Deadline for Member States to supply the Commission and ECHA with information on substances that negatively affect reuse or recycling (para. 2)
12 August 2026Article 5 becomes fully applicable: minimisation duty, 100 mg/kg, PFAS limits. From this date Annex C of EN 13428 no longer creates a presumption of conformity
31 December 2026Commission report, assisted by ECHA, on substances of concern in packaging; the basis for possible follow-up measures (para. 2)
12 August 2030Evaluation of whether the PFAS rule must be amended or repealed because of overlaps with REACH, POPs or food-contact law (para. 5)
12 August 2033Evaluation of whether Article 5 and the design-for-recycling criteria have contributed sufficiently to minimisation (para. 9)

One special rule concerns reusable packaging: the obligation to bring into conformity, withdraw or recall non-conforming packaging does not apply to reusable packaging placed on the market before 11 February 2025. If you run a reuse pool, be able to evidence when your assets were placed on the market.

The 31 December 2026 report is the date worth watching. It may name substances that are then regulated through REACH restrictions under Article 68(1) and (2) or through design-for-recycling criteria under Article 6(4) PPWR. That — not Article 5 itself — is where the next concrete substance limits will come from.

From limit value to data model

Article 5(6) says in one sentence where all of this lands: compliance with paragraphs 4 and 5 must be demonstrated in the technical documentation drawn up in accordance with Annex VII. Proof is therefore not a lab report in a folder but part of the same file the declaration of conformity under Article 39 and Annex VIII rests on.

What that file has to contain follows from the structure:

  • A bill of materials for the packaging unit, covering every material and component, including inks, varnishes, adhesives and labels.
  • Evidence per component — a supplier declaration referencing Regulation (EU) 2025/40, or your own test report, with date, method and limit of detection.
  • The reasoning that turns those individual pieces into a statement about the whole unit. Test reports alone do not do this step.
  • For food-contact packaging, additionally the total fluorine result and, above 50 mg/kg, the fluorine attribution obtained from the supply chain.
  • For the minimisation duty, a traceable assessment of which substances of concern were identified and which reduction measures were taken or examined.

This is exactly where the PPWR meets the digital product passport. The Ecodesign Regulation requires products carrying a passport to disclose information on substances of concern — using the same definition as the PPWR. If you have to capture your packaging substance data in structured form anyway, put it in the data model that will later feed the passport rather than in a standalone packaging file. The ESPR requirements and Article 5 are asking for substantially the same information.

Five steps to get ready

1. Split the portfolio by food contact

Two piles: food-contact packaging and everything else. The first needs heavy-metal and PFAS evidence; the second needs heavy-metal evidence plus a minimisation assessment. Coated papers, grease barriers and baking substrates belong at the top of the first pile.

2. Build bills of materials, not material names

For each packaging unit, capture every component: substrate, coating, ink, varnish, adhesive, label, closure, window. Without this you cannot make a conformity statement that matches the Regulation’s reference point.

3. Put suppliers on the hook in writing

Send requests that reference Regulation (EU) 2025/40, Article 5 and Article 16 explicitly, with a response deadline. Ask for test reports, not summaries, and for food contact ask specifically for total fluorine figures. Write the above-50 mg/kg information duty into new framework contracts.

4. Test on a risk basis

Not every SKU needs its own laboratory work. Group by identical material recipe: same board, same ink, same varnish, same adhesive. Priority goes to coated grease barriers, heavily pigmented prints, recycled content of unclear origin, and imported packaging without dependable supply-chain data.

5. Move the evidence into the technical documentation

Not into a folder, but into the Annex VII file that also feeds the PPWR declaration of conformity. Decide who updates that file when a supplier changes a recipe — that is where packaging files go stale in practice.

Frequently asked questions

Does Article 5 apply to packaging produced before 12 August 2026?

What matters is placing on the market, not production. Packaging placed on the market before the date is unaffected; place it afterwards and the requirements apply. There is no sell-through period for the substance requirements comparable to the three-year rule for labelling in Article 12(12). For reusable packaging placed on the market before 11 February 2025, the obligation to bring into conformity, withdraw or recall does not apply.

Do we have to lab-test every packaging item?

No. The Regulation requires proof in the technical documentation, not a test per SKU. Robust supplier declarations that clearly reference the requirements can carry the claim, as can assessments covering groups of identically constructed packaging. Laboratory testing is needed where the supply chain cannot supply dependable data or the risk is high.

What counts as food-contact packaging?

The PPWR does not define the term separately; the food-contact framework governs, meaning packaging intended to come into contact with food or that can reasonably be expected to do so. Primary packaging is in scope. An outer carton that does not touch the food and whose constituents cannot migrate to it usually is not — the boundary has to be reasoned case by case and that reasoning belongs in the documentation.

Is our packaging PFAS-free if we never used PFAS?

Not automatically. The rule captures intentionally added and unintentionally present PFAS alike, with recycled content, processing aids and equipment as the usual contamination routes. Available work does suggest exceedances occur mainly where PFAS were added deliberately. A total fluorine screen is the cheapest way to evidence that assumption.

Who is liable if a supplier’s information is wrong?

Towards market surveillance it is the manufacturer placing the packaging on the market, or whose name or brand it carries, that answers — that party draws up the technical documentation and signs the declaration of conformity. False supplier information may found a civil claim, but it does not discharge the public-law duty. That is why contractually securing the Article 16 information duties is not a formality.

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