What the EU's PPWR FAQ Means for Substances of Concern in Packaging
As the 12 August 2026 application date for the Packaging and Packaging Waste Regulation (Regulation (EU) 2025/40) draws closer, the European Commission has issued an FAQ addressing how substances of concern (SoC) will be handled under the new framework. The regulation is designed to cut down on harmful substances in packaging while also pushing the EU toward safer recycling and a more circular use of materials.
How a Substance Gets Classified as "of Concern"
Instead of writing a fresh definition, the PPWR pulls its substance-of-concern criteria directly from the Ecodesign for Sustainable Products Regulation (ESPR). The Commission's FAQ is clear that meeting just one of the listed conditions is enough to trigger SoC status — there's no requirement to satisfy multiple criteria at once.
A substance falls into this category if it's listed under REACH Article 57 as a substance of very high concern, carries a relevant hazard classification under CLP rules, is covered by the EU's POP Regulation (2019/1021), undermines a material's reusability or recyclability, or otherwise meets a condition in the ESPR's broader SoC criteria. Because qualifying under any one of these is sufficient, the practical reach of the rule extends well past conventional packaging restrictions, putting recyclability and circular material use on equal footing with toxicity.
Obligations Starting 12 August 2026
A handful of significant PPWR requirements kick in on this date. Manufacturers will be obligated to design and produce packaging in a way that keeps substances of concern at a minimum, both in terms of presence and concentration. The regulation also keeps existing concentration limits intact for four heavy metals — lead, cadmium, mercury, and hexavalent chromium.
Separately, food-contact packaging becomes subject to PFAS limits as of the same date. The FAQ specifically confirms that these limits apply whether the PFAS was added on purpose or turned up unintentionally, which is a meaningful detail for businesses working with recycled materials, printing inks, adhesives, coatings, or layered packaging formats where stray PFAS contamination is a real risk.
Not One Limit to Rule Them All
A key clarification in the FAQ is that the PPWR doesn't set a single concentration ceiling that applies across every substance of concern. PFAS has its own limits, the four heavy metals have theirs, and everything else falls under general minimization and conformity obligations rather than a fixed numerical threshold. In practice, this means companies can't treat EU packaging compliance as a single pass/fail test — it requires more robust data tracking, closer coordination with suppliers, and thorough technical documentation across multiple compliance pathways at once.
Where Responsibility Sits in the Supply Chain
Article 16 of the PPWR places an information-sharing duty on suppliers, who must hand manufacturers what they need to prove their packaging conforms to the rules. From there, manufacturers placing packaging on the EU market are on the hook for using that information to flag substances of concern, run a compliance assessment, and put together the EU PPWR Declaration of Conformity. Given this division of labor, transparent supplier relationships and solid documentation aren't optional extras — they're central to being audit-ready.
EN 13428:2004 No Longer Carries the Same Weight
The FAQ also flags an important shift for companies still leaning on older compliance frameworks: Annex C of EN 13428:2004 will stop providing a presumption of conformity once PPWR takes effect, since it doesn't account for the regulation's expanded definition of substances of concern. Businesses that have used this standard as their main compliance reference will likely need to update their conformity-assessment approach.
Getting Ahead of the August Deadline
With the deadline now just months away, companies should be working through a few priorities: auditing their packaging portfolios for SoC exposure, evaluating where PFAS risk might be hiding in their supply chain, tightening supplier documentation practices, improving how packaging-related data is tracked and shared internally, and refreshing their conformity assessment procedures to match the new rules.
The overarching message from the Commission's FAQ is that substances-of-concern compliance has moved beyond a narrow chemical-restriction issue. It's now equally a matter of data management, supply chain traceability, and documentation discipline. Businesses that start adjusting now will be far better positioned to manage risk and keep uninterrupted access to the EU market once the rules take full effect. Connect with Freyr to assess packaging risks, strengthen supplier documentation, and stay ahead of August 2026 requirements.
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