ECHA’s Updated EU PFAS Restriction Proposal: What Manufacturers Must Know

The PFAS compliance gauntlet just got thrown down harder and it’s not optional anymore. On 20 August 2025, the European Chemicals Agency (ECHA) dropped the 14th version of its PFAS Background Document under REACH, incorporating over 5,600 stakeholder comments and adding eight new industry sectors now in the crosshairs. Meanwhile, a new “controlled‑use” path offers limited exemptions—but only under a microscope of strict risk controls. This isn’t a drill. If you're in electronics, textiles, pharma, or defense, your compliance roadmap just got a full‑length rewrite.

What’s Changed: Key Updates in the Background Document

• Version 14 released on 20 August 2025, reflecting deep analysis of input from Denmark, Germany, the Netherlands, Norway, and Sweden

• Eight additional sectors now assessed, expanding the scope beyond the original proposal to include:

  • Printing applications
  • Sealing systems
  • Machinery operations
  • Medical uses like pharmaceutical packaging and excipients
  • Military and explosive applications
  • Technical textiles
  • Broad industrial uses (e.g., solvents, catalysts)

• New "alternative restriction options" introduced, allowing controlled PFAS use in specific cases subject to stringent risk controls. These include:

  • PFAS manufacturing
  • Transport
  • Electronics & semiconductors
  • Energy sectors
  • Sealing and machinery applications
  • Technical textiles.

• ECHA has outlined potential PFAS thresholds for enforceable use:

  • 25 ppb for any individual PFAS
  • 250 ppb total PFAS (excluding polymeric PFAS)
  • 50 ppm total PFAS (including polymeric PFAS) Relevant actors must demonstrate compliance if total fluorine exceeds 50 mg F/kg.

Sector Impacts: Who’s in the Line of Fire

• Electronics & Semiconductors

  • PFAS are critical in chip fabrication and assembly. Controlled‑use exemptions might buy time—but documentation, testing, and substitution scouting must start yesterday.

• Medical Devices & Pharma Packaging

  • PFAS in packaging and excipients are under increased scrutiny. Alternatives must meet safety and stability thresholds or risk regulatory pushback.

• Technical Textiles & Industrial Goods

  • Industries using PFAS for water/oil repellence, filtration, or catalyst supports will need rigorous risk assessments and potentially staggered phase‑out plans.

• Defense, Military & Explosives

  • PFAS in protective gear, coatings, and munitions often lack viable substitutes. Controlled exemptions are on the table—but only under strict usage conditions and timelines.

• Printing, Sealing & Machinery

  • PFAS are ubiquitous in inks, adhesives, seals, and gaskets. Redesign or substitution may be more cost-intensive than anticipated.

Funding & Alternatives

The EU is investing in PFAS-free innovation through Horizon Europe and national grants, supporting projects in textiles, coatings, and electronics. But critical sectors — semiconductors, defense, pharma — still lack commercially viable substitutes, making the RO3 “controlled-use” pathway central in the near term.

Ban, Exemptions, and New Controlled‑Use Models

Originally, the proposal centered on two scenarios:

• RO1: Full ban with an 18-month transition
• RO2: Ban with time-limited derogations (5–12 years, species-dependent)

Now, the dossier submitters have included RO3: conditional continued use for sectors where PFAS alternatives remain unviable but risks are demonstrated to be controlled ﹣ essentially a framework for critical industries to buy time under tight scrutiny.

If accepted, RO3 becomes a double-edged sword: it preserves functionality—but only for organizations with airtight compliance infrastructure and ongoing monitoring.

NGO Pressure & Litigation

NGOs like ChemTrust and ChemSec continue to press for a universal PFAS ban, warning against broad derogations. In 2025, Le Monde reported intense industry lobbying to narrow PFAS definitions — criticized by scientists. At the same time, PFAS lawsuits are spreading across Europe, echoing U.S. litigation, adding urgency for regulators to act.

What’s Next: RAC, SEAC & the Road to 2026

Now it’s committee time:

• RAC (Risk Assessment Committee) will assess toxicological data, exposure, and environmental ramifications.
• SEAC (Socio-Economic Analysis Committee) will evaluate the macro- and micro-economic impacts of restrictions or exemptions.

Once their independent opinions are issued, likely in late 2025 or early 2026, the European Commission, together with EU Member States, will determine enforcement specifics and timing.

In September 2025, RAC and SEAC reached their first provisional conclusions: – RAC: PFAS in electronics & semiconductors – SEAC: PFAS in energy & lubricants – Both: PFAS manufacturing and “horizontal issues” such as thresholds, hazard assessments, and emission controls.

Next steps: – Dec 2025 → committees revisit electronics, semiconductors, and manufacturing. – Mar 2026 → RAC adopts its final opinion, SEAC agrees on a draft opinion → launches a 60-day consultation. – End 2026 → SEAC adopts final opinion; Commission + Member States then decide.

Enforcement could start in 2026, with phased rollouts into 2027.

National Actions Inside the EU While the EU-wide restriction is still under review, some countries have already acted: – Denmark banned PFAS in food packaging (2020). – Netherlands enforced strict PFAS soil and water thresholds. – Germany restricted firefighting foams and some textiles. – Sweden banned PFAS firefighting foams in training.

These unilateral steps show regulators won’t wait for Brussels to finalize rules.

Action Plan: What Manufacturers Must Do Now

1. Audit your PFAS footprint

   • Map PFAS-containing materials in your products and supply chain.

2. Engage suppliers proactively

   • Push for compliance data, PFAS alternatives, and phase-out plans.

3. Run risk and socio-economic impact assessments

   • Especially if controlled-use exemptions may apply.

4. Prepare technical documentation and testing protocols

   • Tight thresholds like 25 ppb and 250 ppb demand analytical capability and due diligence.

5. Join trade groups or compliance networks

   • Stay updated and influence potential modifications.

Prepare for SCIP & Digital Product Passport (DPP) PFAS compliance will tie into SCIP database reporting (for SVHCs in articles) and Digital Product Passports (DPPs) for electronics, textiles, and other products under the Ecodesign Regulation. Companies will need integrated data systems, not siloed spreadsheets.

Conclusion

The PFAS regulatory landscape just got more formidable and more complex. Prepare or lose ground fast. Need to automate your PFAS strategy with reporting, exemptions management, and compliance documentation without dragging spreadsheets into meetings? Acquis Compliance is built for that. Let’s talk.