PFAS in EU Cosmetics: What Brands Must Know About the Incoming Regulation 1223/2009 Restrictions

A 2021 study published in Environmental Science & Technology Letters tested 231 cosmetic products sold across North America and Europe and found PFAS indicators in 52% of them — with waterproof mascaras and long-wear foundations among the most heavily contaminated categories. That finding didn’t stay in academic journals for long. It landed in regulatory dossiers across the EU, and the legislative response has been building steadily ever since.

If you’re a cosmetics brand selling into the EU market — or planning to — PFAS is no longer a niche toxicology concern. It’s becoming a compliance deadline, and the timeline is tighter than most product development cycles allow for.

What PFAS Are, and Why Formulators Reached for Them

PFAS stands for per- and polyfluoroalkyl substances. There are over 10,000 individual PFAS chemicals, unified by a chain of carbon-fluorine bonds that makes them extraordinarily resistant to heat, water, and chemical degradation. That stability is precisely what made them attractive to cosmetics formulators. In practice, it translates to water resistance in mascara and eyeliner, extended wear in foundations and primers, improved spreadability in skin-conditioning treatments, and a silky skin feel that has proven difficult to replicate with alternatives.

Common PFAS in cosmetics formulations include polytetrafluoroethylene (PTFE, sometimes marketed as “Teflon particles”), perfluorooctyl triethoxysilane used in hair smoothing and skin care products, and a range of fluoropolymers used as film-forming agents. None of these are obscure or exotic — they appear in mainstream product lines sold across EU retail channels every day.

The problem, of course, is the same property that made them useful: they don’t break down. Not in the environment, not in the human body. They accumulate in tissue, in water systems, and in soil across the food chain. The term “forever chemicals” exists for a reason, and regulators have spent the last decade moving from acknowledgement to action.

Where Regulation (EC) No 1223/2009 Currently Stands

Regulation (EC) No 1223/2009 — the foundational EU legal framework for cosmetic products — already prohibits certain PFAS. Annex II of the regulation lists substances that must not be present in cosmetic products placed on the EU market, and it includes specific long-chain perfluorinated compounds. Perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) are effectively off the table entirely, reinforced by their classification under the POPs Regulation (EU) 2019/1021.

But here’s the structural limitation that regulators have been working around: Annex II prohibits specific listed substances. PFAS as a chemical class are not comprehensively banned under the current regulation. That creates a substitution dynamic that is now well understood by both industry and regulators — a formulator can technically swap a prohibited C8 PFAS for a shorter-chain C6 or C4 compound and remain technically compliant, even though the substituted substance may carry similar environmental persistence. The Scientific Committee on Consumer Safety (SCCS) has flagged this gap in multiple opinions, and it is precisely this dynamic that is driving the push for a class-wide restriction.

The Cosmetic Products Regulation also requires that every product placed on the EU market have a Cosmetic Product Safety Report (CPSR) signed off by a qualified safety assessor. If your formulation contains PFAS that are currently permitted, your CPSR should still address their toxicological profile — and an increasing number of safety assessors are now flagging PFAS presence as a risk factor warranting proactive reformulation review, even before a formal ban is in place.

The ECHA Universal Restriction Proposal: Scope and Timeline

The more significant development is happening under REACH. In January 2023, the national chemical authorities of Germany, the Netherlands, Denmark, Sweden, and Norway jointly submitted a universal restriction dossier to ECHA covering essentially all PFAS, across all uses and all sectors. This was one of the most ambitious restriction proposals ever filed under REACH Annex XVII — covering not a single substance or a narrow group, but an entire chemical class of 10,000+ compounds.

ECHA’s Committee for Risk Assessment (RAC) and Committee for Socioeconomic Analysis (SEAC) conducted public consultations and developed their scientific opinions through 2023 and 2024. The European Commission is now processing those opinions and working toward a formal restriction decision. Under standard REACH procedure, the interval between committee opinions and a formal Commission decision runs 18 to 36 months — which places the formal restriction somewhere in the 2025–2027 window, depending on the pace of the Commission’s regulatory process.

Once published in the EU Official Journal, most uses are expected to face a transition period of approximately 18 months before the restriction enters into force. For cosmetic applications where viable alternatives exist — and for most product categories, regulators believe they do — the shorter transition window is more likely to apply than the longer derogations being sought by certain industrial sectors.

For reference, the working timeline looks like this:

• January 2023: Universal PFAS restriction dossier submitted to ECHA by five national authorities
• 2023–2024: RAC and SEAC public consultations and opinion development
• 2024–2026: European Commission review and formal restriction decision process
• ~18 months post-publication: Entry into force for most cosmetic applications
• Realistic entry into force range: 2027–2028, based on current trajectory

These are estimates. REACH restriction timelines have historically slipped, and the cosmetics sector may succeed in negotiating specific carve-outs or extended transition periods for particular product types. But the direction of travel is not in doubt, and the brands that are reformulating now will be the ones with verified stability data and compliant CPSRs ready to go when deadlines crystallise.

What This Means If You’re Selling — or Entering — the French Market

France warrants specific attention here. In early 2024, the French government published its national PFAS action plan (Plan national sur les PFAS), which explicitly targets consumer products including cosmetics. The DGCCRF — France’s Directorate General for Competition Policy, Consumer Affairs and Fraud Control — has stepped up market surveillance on PFAS-containing products, and French consumer advocates have been vocal enough to give retailers commercial reason to act ahead of regulatory deadlines.

France is not an outlier in terms of regulatory ambition, but it does move faster than EU-average enforcement suggests. Brands with significant exposure to French retail, pharmacy (parapharmacie), and professional channels should treat DGCCRF surveillance as a near-term risk rather than a future-state concern. The EU cosmetics market generates approximately €90 billion in annual turnover, and France accounts for a significant share of both production and consumer demand. Reputational risk in this market from PFAS association is real and growing.

Five Steps to Get Ahead of the Restriction

If you’re a brand owner, regulatory affairs manager, or EU responsible person working through this, here’s a practical sequence that’s working for clients we’re guiding through the process:

1. Conduct a full PFAS ingredient audit. Go beyond your INCI list. Cross-reference every ingredient — including process aids, excipients, and components not always declared — against the ECHA restriction proposal’s substance scope. With 10,000+ compounds in scope, this requires specialist chemical database access, not a manual spreadsheet search.

2. Engage your contract manufacturers early. Reformulation timelines for complex products like waterproof mascaras, long-wear foundations, or hair-smoothing treatments run 12 to 24 months when you account for stability testing, safety assessment updates, and regulatory notification requirements. The window to start is now — not after the restriction is finalised.

3. Update your CPSRs and PIFs proactively. Your Cosmetic Product Safety Reports and Product Information Files should reflect the current regulatory landscape, including SCCS opinions on specific PFAS. Safety assessors are increasingly expected to demonstrate that PFAS presence has been actively assessed, not simply inherited from an older dossier.

4. Map your responsible person obligations. Under Article 4 of Regulation 1223/2009, the responsible person bears legal liability for compliance. If your EU responsible person isn’t already flagging PFAS as a priority in their compliance monitoring, that conversation needs to happen now.

5. Consider a phased reformulation strategy by product category. Not every product in your portfolio will require the same urgency. Prioritise lines where PFAS use is functionally critical and alternatives are least developed — these are the formulations that will take longest to transition and should enter the R&D queue first.

The brands that will navigate this most smoothly aren’t the ones waiting for the Official Journal publication. They’re the ones that treated the January 2023 ECHA dossier submission as the starting gun it was.

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Written by Sam Sammane, Founder, Care Europe. Learn more about our team

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• PFAS and restricted substance testing for cosmetics ingredients — Qalitex Laboratories provides ISO 17025-accredited analytical testing for PFAS and Annex II restricted substances in cosmetic formulations.
• Cosmetics and NHP compliance testing for Canadian market entry — Androxa supports brands launching in Canada under Health Canada’s cosmetics and natural health product frameworks.