Materials & chemicals
PPWR substances of concern
Last regulatory verification: 12 August 2026 · 4 official sources
Article 5 limits substances of concern in packaging. What is binding now, what ECHA is still preparing, and how to document substances in the Annex VII file.
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Article 5 of Regulation (EU) 2025/40 requires packaging to minimise substances of concern in its composition, keeps the heavy metals sum limit for lead, cadmium, mercury and hexavalent chromium, and adds a specific PFAS restriction for food-contact packaging. Beyond that, further restrictions depend on ongoing work supported by ECHA.
Regulatory status
In force- Legal basis
- Article 5, Regulation (EU) 2025/40
- Applies from
- 12 August 2026
- Binds
- Manufacturers and importers of packaging
The obligation applies now. What is still developing is the scope of further restricted substances, not whether Article 5 bites.
What is binding today
Three things. First, the sum of lead, cadmium, mercury and hexavalent chromium in packaging or packaging components is capped — a limit carried over from the previous packaging regime, with the narrow derogations that regime allowed. Second, packaging must be designed so that substances of concern are minimised in its composition, including in inks, coatings, adhesives and closures. Third, the PFAS restriction for food-contact packaging applies from the same date, with its own thresholds.
What is still being developed
ECHA supports the Commission's assessment of substances of concern in packaging, including studies and data collection that can lead to further restrictions. Treat that work as an early-warning signal for material choices with long lifespans, not as a present obligation. Watch it if you are specifying new coatings, barrier layers or recycled feedstocks that you expect to run past 2030.
Substances of concern is broader than a restricted list
What to hold in the Annex VII file
Full component and material breakdown
Every layer, coating, ink, adhesive, closure and label, not just the primary substrate. Substances of concern usually enter through the components nobody lists.
Usually held by: Manufacturer, built from supplier data
Supplier declarations covering the heavy metals limit
Statements that reference the applicable limit and the material actually supplied, with a date and a responsible entity.
Usually held by: Material and component suppliers
Analytical results where the material history is unknown
Particularly relevant for recycled feedstocks, imported components and legacy inks, where declarations alone are weak evidence.
Usually held by: Manufacturer or a testing laboratory
A minimisation rationale per material
A short, dated record of the substances considered, the alternatives assessed, and why the final specification was chosen.
Usually held by: Manufacturer
A re-check trigger
A defined point — supplier change, formulation change, recycled content change — at which the substances assessment is redone.
Usually held by: Manufacturer
Recycled content makes this harder, not easier
Recycled feedstock carries the history of whatever it was before. As recycled content requirements phase in towards 2030, the substances question and the recycled content question stop being separable: you will need evidence that the recycled input meets both the content target and the substance limits. Suppliers who can evidence one but not the other are a known gap.
Official sources for this page
Every statement above is written against these sources. Where a Commission document and the Regulation differ, the Regulation controls.
- Regulation (EU) 2025/40 — EUR-LexBinding law
- ECHA activities under PPWROfficial implementation / research
- ECHA current PPWR activitiesOfficial implementation / research
- EFSA Food Contact MaterialsOfficial implementation / research
- Sources last verified
- 12 August 2026
- Content last updated
- 12 August 2026
- First published
- 12 August 2026
Written and maintained by the PPWRDeclaration.com editorial team. General information about Regulation (EU) 2025/40 — not legal advice.
Why this matters
What happens if the documentation isn't there
The packaging can be restricted
Packaging without valid technical documentation is treated as non-compliant. Market surveillance authorities can require corrective action, restrict sale, or withdraw it from the market.
Penalties apply per Member State
Each Member State sets its own penalties for non-compliance, and they apply where the packaging is placed on the market — not where your business sits.
Buyers block you first
Retailers, distributors and importers increasingly ask for the Declaration and supporting evidence before onboarding. No file usually means no listing.
Late evidence costs more
Supplier declarations and lab testing have long lead times. Discovering a gap close to a deadline forces rushed testing or packaging redesign.