PPWR Article 5: Substances of Concern Explained

PPWR Article 5: Substances of Concern in Packaging — the Brand-Owner Evidence File

Of all the obligations that switch on for brand owners on August 12, 2026, Article 5 of Regulation (EU) 2025/40 is the one most teams have quietly deprioritised. Recyclability grading has a test protocol. Minimisation has a calculation. Recycled content has a percentage. Article 5 has none of that — it has a chemistry question you cannot answer from your own building, and a legal exposure that sits on your signature.

There is no grace period. The heavy-metal limit has applied since January 1, 2026. The PFAS ban in food-contact packaging applies from August 12, 2026 with defined analytical thresholds. And the general duty to minimise substances of concern applies to every packaging unit you place on the EU market, whether or not it touches food. If your Declaration of Conformity claims Article 5 compliance and a market-surveillance authority asks what that claim rests on, the answer must be a documented evidence chain — not a supplier email saying "we confirm compliance."

What Article 5 Actually Says

Article 5 does three separate things, and they are routinely conflated. Treating them as one requirement is the single most common reason a technical file fails review.

First, a hard numerical ceiling on four heavy metals. Article 5(4), read with Annex V, keeps the legacy limit from the old Packaging Directive: the sum of lead (Pb), cadmium (Cd), mercury (Hg) and hexavalent chromium (Cr VI) must not exceed 100 mg/kg in packaging or any packaging component. This is a total, not a per-substance figure, and it applies regardless of what is inside the pack. It has been in force since January 1, 2026 — meaning any non-compliant pack on shelf today is already unlawful, not pending.

Second, a specific PFAS restriction on food-contact packaging. From August 12, 2026, food-contact packaging may not be placed on the EU market if it contains per- and polyfluoroalkyl substances at or above 25 ppb for any individual PFAS measured by targeted analysis, or 250 ppb for the sum of targeted PFAS. Unlike the heavy-metal rule, this one comes with analytical method expectations, which means the evidence is a test report or a substance-level supplier declaration — not a generic statement.

Third, a general minimisation duty on substances of concern.Article 5(1) requires that packaging be manufactured so the presence and concentration of substances of concern is minimised, including in the packaging itself and in any of its components. "Substances of concern" is a defined term, and it is broader than most packaging teams assume. It captures REACH candidate-list SVHCs, persistent organic pollutants under Regulation (EU) 2019/1021, substances meeting the hazard classes in Part 3 of Annex VI to the CLP Regulation — and, critically, substances that negatively affect the re-use or recycling of the packaging material. That last limb is what pulls ordinary functional additives into scope.

Why the Third Limb Is the Expensive One

A brand owner can usually clear heavy metals and PFAS with targeted testing on a defined set of components. The recyclability-impairing limb is harder because it has no closed list. A substance can be entirely benign from a toxicological standpoint and still be a substance of concern under PPWR if it wrecks the recycling stream.

In practice the recurring offenders across a typical FMCG or personal-care portfolio are:

• Carbon black pigments in rigid plastic — NIR-invisible to sorting equipment, so the pack is routed to residual waste regardless of its polymer. This alone can drop an otherwise clean mono-PP pot from grade B to grade D under Annex II.
• Non-wash-off pressure-sensitive label adhesives on PET bottles — they survive the caustic wash and contaminate the flake, which is why EPBP and RecyClass protocols treat adhesive chemistry as a pass/fail gate rather than a scoring input.
• PVC and PVDC barrier layers — chlorine in the fibre or PET stream degrades recyclate quality and is treated as a disqualifier by most national sorting specifications.
• Oxo-degradable additives — already restricted elsewhere in EU law, and categorically incompatible with mechanical recycling.
• Mineral-oil residues (MOSH/MOAH)in recycled-fibre packaging — not limited by PPWR itself, but squarely within Article 5(1)'s minimisation duty, and separately constrained by the German LFGB 28th Recommendation and Swiss Ordinance RS 817.023.21.
• Bisphenols and certain UV stabilisers in coatings and closures — SVHC exposure that migrates onto your file the moment a candidate-list update lands.

Note what these have in common: none of them are chosen by the brand owner. They are chosen by a masterbatch supplier, a label converter, a coating formulator or a resin producer somewhere three tiers back. Article 5 makes them your problem anyway, because Article 15 makes the brand owner whose trademark is on the pack the manufacturer.

Who Owes You the Data — and What Article 16 Forces

The mechanism that makes Article 5 workable is Article 16. Suppliers of packaging and packaging components must provide the manufacturer with all information and documentation necessary to demonstrate conformity, including on substances. This is a legal obligation on them, not a commercial favour to you — and it is the clause to quote when a supplier stalls.

Where teams go wrong is accepting the wrong artefact. A supplier PDF that says "this product complies with Regulation (EU) 2025/40" is worthless in an Annex VII technical file: it asserts the conclusion your own file is supposed to establish. What you need, per component, is:

• Full material and additive declaration to the level of the specific substance — polymer grade, pigment system, additive package, adhesive chemistry, coating and varnish chemistry, ink series.
• An explicit REACH candidate-list screening statement naming the candidate-list version screened against, with a date. A screening against an eighteen-month-old list is not current evidence.
• Heavy-metal conformity evidence against Annex V — a test report or a formulation-based justification with the calculation shown, not a bare tick-box.
• PFAS status at substance level for anything food-contact, with the analytical method and the limit of quantification stated so you can show it clears 25 ppb / 250 ppb.
• A recyclability-impairment statement — carbon black, PVC/PVDC, oxo-additives, wash-off behaviour of adhesives, mineral-oil barrier arrangements.
• A change-notification commitment obliging the supplier to tell you before a formulation change, not after. Without this, every declaration you hold decays silently.

The Evidence Chain Behind Your Declaration of Conformity

Article 39 requires a Declaration of Conformity per packaging type, and Annex VIII fixes what it must contain. Article 38 and Annex VII require the technical documentation that sits behind it under Module A internal production control. For Article 5, the file has to make a reviewer able to reconstruct your reasoning without calling you.

A defensible Article 5 section of an Annex VII file contains, per packaging type: a component breakdown with the mass of each component; the supplier declaration for each component with its date and the candidate-list version it screened against; heavy-metal evidence with the summation across components showing the 100 mg/kg total; PFAS evidence for food-contact components; a written rationale for each substance-of-concern decision you took, including ones you consciously accepted; and the review date at which the whole set will be re-screened.

That last item matters more than it looks. The REACH candidate list is updated roughly twice a year. The Commission, assisted by ECHA, must report on substances of concern in packaging by December 31, 2026, and the Article 6(4) delegated acts due by January 1, 2028 may introduce further restrictions. An Article 5 file that is correct in August 2026 and never revisited will be wrong by 2027. Build the re-screening cadence into the file itself, with a named owner.

Where This Bites Hardest: Portfolio Scale

The Article 5 problem is not intellectually difficult for one pack. It is operationally brutal for four hundred. A mid-size brand owner with 400 SKUs across six pack architectures is looking at somewhere between 1,500 and 3,000 individual component declarations, each with its own supplier, date, screening version and renewal clock.

Teams that try to hold this in a shared spreadsheet plus a folder of PDFs discover three failure modes within a quarter. Declarations expire without anyone noticing. The same component is declared differently by two suppliers and nobody reconciles it. And when a candidate-list update lands, there is no way to answer "which of our SKUs contain this substance?" in less than a fortnight of manual work — which is exactly the question an authority will ask, and exactly the question that determines whether you recall or carry on.

The structural fix is to hold substances at component level rather than SKU level, so a single supplier change propagates to every affected pack automatically. This is also why Article 5 work should be sequenced before recyclability grading rather than after: carbon black and adhesive chemistry decisions determine your Annex II grade, so doing the chemistry first avoids grading the same pack twice. Our PPWR recyclability check assumes you already know what is in the pack — Article 5 is how you find out.

A Practical Action Plan Before August 12, 2026

1. Build the component inventory first. Decompose every pack architecture into components with masses. You cannot screen substances against a SKU; you screen them against a component. Most brand owners find they have far fewer distinct components than SKUs, which is the good news.
2. Issue a single structured supplier request, not free-text emails. Cite Article 16 explicitly, set a return date, and specify the artefact you require — full material declaration, candidate-list version and date, heavy-metal evidence, PFAS status where food-contact, and a recyclability-impairment statement.
3. Triage by risk, not alphabetically. Prioritise food-contact components (PFAS exposure), coloured and printed components (heavy-metal pigments), coated and barrier components (fluorochemistry, PVDC), and anything with an adhesive.
4. Test where the declaration is weak. Targeted analysis on a sampled basis is far cheaper than a recall. Prioritise imported components and any supplier who returned a generic conformity statement.
5. Close out the known disqualifiers. Carbon black in rigid plastic, PVC/PVDC barriers and non-wash-off adhesives are the three that most often force a redesign. Reformulating takes longer than documenting, so start these now and document the rest in parallel.
6. Write the rationale, not just the result. For every accepted substance of concern, record why minimisation was not further possible. Article 5(1) is a minimisation duty, and a reviewer will accept a reasoned trade-off far more readily than silence.
7. Set the re-screening clock. Diarise a candidate-list re-screen twice yearly and a full file review annually, with a named owner per pack architecture.

How PPWR Connect Helps

Article 5 is a data problem disguised as a chemistry problem. PPWR Connect holds substances at component level, tracks each supplier declaration with its candidate-list version and expiry, flags the packs affected when a substance status changes, and carries that evidence straight into the Annex VII technical file and the Annex VIII Declaration of Conformity — so "which SKUs contain this substance?" is a query rather than a fortnight. If you are choosing tooling for this, our PPWR software comparison sets out what to look for, and the declaration of conformity template shows how the Article 5 evidence lands in the final document.

The fastest way to find out where your portfolio actually stands is to run the free PPWR assessment — it takes a few minutes and returns the specific Article 5 gaps to close before August 12, 2026.