Most packaging teams have heard the PFAS headline. Far fewer have worked through what Article 5 of Regulation (EU) 2025/40 actually requires - across all substance categories, for every packaging component, with documented evidence in hand by 12 August 2026. This post is for the quality, R&D, and regulatory managers who need the full picture.
What Article 5 Actually Says
Article 5 of the PPWR is titled "Requirements for substances in packaging." Its core obligation is straightforward: packaging placed on the EU market must be manufactured so that the presence and concentration of substances of concern is minimised. That obligation extends beyond the outer pack body. Coatings, inks, adhesives, varnishes, liners, labels, closures, sealants, and barrier layers are all in scope - if they form part of the packaging system, they are subject to Article 5.
The article then sets three concrete, hard-limit requirements that apply from 12 August 2026:
- Heavy-metal concentration limits - for all packaging types
- PFAS limits - for food-contact packaging specifically
- Minimisation of substances of concern - a broader, ongoing obligation
Heavy Metals: The Carried-Over Limit That Still Catches Teams Out
The heavy-metal rule is not new. The 100 mg/kg combined concentration limit for lead, cadmium, mercury, and hexavalent chromium was already embedded in Directive 94/62/EC. The PPWR carries it forward verbatim: Article 5(4) of Regulation (EU) 2025/40 requires that the sum of the concentrations of lead, cadmium, mercury, and hexavalent chromium in packaging or packaging components shall not exceed 100 mg/kg.
Because the limit is familiar, teams sometimes assume their existing supplier declarations are sufficient. They are not - at least not automatically. The PPWR now requires this to be documented in a formal technical file (Annex VII) that backs the Declaration of Conformity. A legacy certificate from 2019 that references the old Directive is not the same as a current declaration referencing Regulation (EU) 2025/40.
The 100 mg/kg heavy-metal limit applies to all packaging types — not just food contact. Printed secondary packaging, coloured closures, and metallic inks are common risk areas. Verify that supplier declarations explicitly cover hexavalent chromium (Cr(VI)), which is often omitted from older test reports.
Testing for heavy metals is well-established. Labs have decades of experience, and the analytical methods are standardised. The compliance gap here is almost always documentation, not chemistry.
PFAS: Three Thresholds, Not One
The PFAS restriction is where Article 5 breaks new ground. From 12 August 2026, food-contact packaging cannot be placed on the EU market if it contains PFAS at or above three threshold levels: 25 ppb for any individual non-polymeric PFAS measured by targeted analysis; 250 ppb for the sum of targeted non-polymeric PFAS; and 50 ppm for total PFAS including polymeric PFAS.
The three-tier structure matters operationally:
The Commission's draft guidance recommends a stepwise testing approach: start with a total fluorine (TF) screen. If TF is below 50 ppm, the material is considered compliant and no further testing is required. If TF exceeds 50 ppm, differentiate organic from inorganic fluorine. Only if total organic fluorine still exceeds 50 ppm is targeted PFAS analysis - checking the 25 ppb and 250 ppb limits - required.
This tiered approach matters for portfolio prioritisation. PFAS testing costs start at a few hundred euros for a total fluorine screen and can reach several thousand euros for full targeted analysis per packaging type. At scale, running targeted analysis on every SKU without a screening step is both unnecessary and expensive.
High-risk material categories to prioritise:
- Grease-resistant paper and board (fast food, bakery, deli)
- Coated and barrier-treated fibre-based packaging
- Food wrappers, trays, bowls, and liners
- Packaging with recycled content (non-intentional PFAS contamination)
- Imported packaging from suppliers without established PFAS testing programmes
If total fluorine content falls below 50 ppm, the packaging is considered compliant without further targeted PFAS testing. This screening threshold is your first filter - use it.
Bisphenols and the Broader Substances-of-Concern Picture
PFAS and heavy metals are the two hard limits in Article 5. But the regulation's substance-of-concern framework is wider, and bisphenols - particularly BPA - sit at the intersection of PPWR, REACH, and food-contact-material law.
BPA is already listed as a Substance of Very High Concern (SVHC) on the REACH Candidate List due to its endocrine-disrupting properties and reproductive toxicity. Under food-contact-material law, Commission Regulation (EU) 2024/3190, adopted in December 2024, establishes specific requirements for BPA and other hazardous bisphenols in food contact materials and articles, operating as a specific measure under Framework Regulation (EC) No 1935/2004.
The practical consequence: food-contact packaging teams must now manage compliance under two parallel frameworks simultaneously. The PPWR's Article 5 minimisation obligation covers packaging as a product. Regulation (EU) 2024/3190 governs the food-contact-material safety dimension. Neither replaces the other.
BPA and other hazardous bisphenols can be present in food packaging even when not intentionally added - as impurities, manufacturing by-products, or degradation products - and these non-intentionally added substances (NIAS) may pose chemical safety risks, including through recycling.
The REACH connection: Any substance on the REACH SVHC Candidate List is, by definition, a substance of concern under the PPWR. This means the SVHC list is a living reference for Article 5 compliance - not a static checklist. Teams should monitor ECHA's Candidate List updates as part of their ongoing substance management process.
What's coming via delegated acts: Article 5 is not a closed list. By 31 December 2026, the European Commission - assisted by ECHA - must publish a report on substances of concern in packaging that may negatively affect reuse or recycling, or present unacceptable risks to human health. That report can trigger further restrictions via delegated acts. Ink pigments, certain plasticisers, and flame retardants are among the categories being scrutinised.
What Documentation Does Article 5 Actually Require?
Article 5(6) of the PPWR is explicit: compliance with the heavy-metal and PFAS restrictions must be demonstrated in the technical documentation. That technical file (Annex VII) backs the Declaration of Conformity (Annex VIII) that every packaging manufacturer must issue per packaging type from 12 August 2026.
Separate food-contact from non-food-contact packaging. Within food-contact, flag grease-resistant, coated, barrier-treated, and recycled-content materials as PFAS priority items. All packaging types need heavy-metal coverage.
Request substance declarations that explicitly reference Regulation (EU) 2025/40 — not the old Directive 94/62/EC. A generic 'compliant with all applicable laws' statement is not sufficient for the technical file. Declarations must be component-level and traceable.
For food-contact packaging, start with total fluorine screening. Escalate to targeted PFAS analysis only where TF exceeds 50 ppm. For heavy metals, ICP-MS or ICP-OES testing against EN 13130 methods is standard. Certificates of Analysis must come from accredited laboratories.
The file must include: material composition breakdown, substance declarations per component, test reports (CoAs), and evidence of compliance with the 100 mg/kg heavy-metal limit and, for food-contact packaging, the PFAS thresholds. Retain for 5 years (single-use) or 10 years (reusable) after last placement on market.
The DoC is a self-declaration signed by the manufacturer — the entity whose name or trademark appears on the packaging. It references Articles 5–12 and the supporting technical file. Importers must verify the DoC exists before placing packaging on the EU market; they cannot rely on the supplier's word alone.
One point that trips up many teams: under PPWR, the Declaration of Conformity is a self-declaration - not a CE mark and not a test certificate - and the person who signs it carries personal legal liability for its accuracy. The technical file is the evidence that makes that signature defensible.
The Data Problem Underneath the Compliance Problem
Most companies already use packaging that physically meets Article 5 limits. The gap is proving it - collecting verified substance test results and full material breakdowns from every supplier in the chain, for every packaging type, in a format that survives an authority audit.
That is a data management challenge as much as a chemistry challenge. Supplier declarations arrive as PDFs. Test reports sit in email inboxes. Component-level substance data is scattered across ERP systems, shared drives, and spreadsheets. When a market surveillance authority requests the technical file for a specific SKU, you need to retrieve it in minutes - not days.
The Regulatory Horizon: What Article 5 Doesn't Fix Yet
Article 5 as it stands covers heavy metals and PFAS with hard thresholds, and imposes a minimisation obligation for substances of concern more broadly. But the delegated acts that will define which additional substances face specific restrictions are still pending. The Commission's ECHA-assisted report due by 31 December 2026 will shape that next wave.
Teams building compliance programmes now should treat Article 5 as a floor, not a ceiling. The substance scope will expand. The documentation infrastructure you build for PFAS and heavy metals today - structured supplier data, traceable test reports, component-level declarations - is the same infrastructure you will need when the next delegated act lands.
Working through Article 5 compliance across a large packaging portfolio? Discuss your specific substance documentation gaps with a Packa expert — free of charge, no obligation.
Talk to a Packaging ExpertDoes the PFAS restriction in Article 5 apply to all packaging, or only food-contact packaging?
The specific PFAS thresholds (25 ppb individual, 250 ppb sum, 50 ppm total fluorine) apply only to food-contact packaging from 12 August 2026. The heavy-metal limit (100 mg/kg combined for Pb, Cd, Hg, Cr(VI)) applies to all packaging types. The broader minimisation obligation for substances of concern applies to all packaging.
Is a supplier declaration enough to prove PFAS compliance, or do we need lab tests?
Supplier declarations alone are not sufficient for the technical file. Article 5(6) requires documented evidence. For PFAS, this means Certificates of Analysis from accredited laboratories — at minimum a total fluorine screen, and targeted PFAS analysis if TF exceeds 50 ppm. Declarations support the file but do not replace test data.
How does PPWR Article 5 relate to Regulation (EC) No 1935/2004 on food contact materials?
They operate in parallel. Regulation 1935/2004 is the framework regulation for food contact material safety — it governs migration limits and the general safety requirement that materials must not transfer substances to food in quantities that endanger human health. PPWR Article 5 adds packaging-specific substance restrictions (PFAS, heavy metals, SoC minimisation) on top of that framework. Both sets of requirements must be met simultaneously for food-contact packaging.
When will delegated acts add more substances to the Article 5 restrictions?
The European Commission, assisted by ECHA, must publish a report on substances of concern in packaging by 31 December 2026. That report can trigger further delegated acts restricting specific substances. No firm date for those acts has been set, but teams should monitor ECHA's SVHC Candidate List and the Commission's work programme as leading indicators.
How long must we retain the technical documentation and Declaration of Conformity?
Under PPWR Annex VII, the technical documentation must be retained for 5 years after the last placement on market for single-use packaging, and 10 years for reusable packaging. The DoC must be made available to market surveillance authorities on request.
