Short answer: since 10 October 2026, cosmetic products placed on the EU market may not contain PFHxA and its salts at 25 ppb or more, or PFHxA-related substances at 1,000 ppb or more — two separate sums, measured on the homogeneous material, and the second sum is what most supplier declarations cannot answer.
For two years the restrictions annex of the EU chemicals regulation carried a dated promise about cosmetics. That date has now passed. A specific family of fluorinated substances is restricted in cosmetic products placed on the market from 10 October 2026, and the practical difficulty is not the concept — it is that the limit is expressed as two summed concentrations at parts-per-billion level, measured on the material rather than the product.
If your compliance file was built around a single-substance fluorinated screen, it does not answer the question the regulation asks.
What started applying on 10 October 2026
A 2024 Commission regulation added a new entry to Annex XVII of the EU chemicals regulation, covering undecafluorohexanoic acid — PFHxA — together with its salts and a defined group of related substances. The entry lists product categories and gives each one its own application date, which is why a single blanket "PFAS deadline" in a supplier questionnaire is usually the wrong question.
Cosmetic products are among the categories whose date arrived on 10 October 2026, alongside clothing textiles, footwear, food-contact paper and board, and certain consumer mixtures. Placing non-compliant product on the EU market from that date is prohibited.
The reason this family was grouped rather than listed substance by substance matters commercially: PFHxA-related substances are defined as those with the potential to degrade or be transformed into PFHxA. That definition was written deliberately, because the C6 fluorinated chemistry introduced as a replacement for earlier longer-chain substances can break down toward exactly this molecule.
The two sums, and what they are measured on
The entry sets two thresholds and they are assessed separately. A single number above either limit is a non-compliance, regardless of the other.
| Substance group | Limit | As written in the regulation |
|---|---|---|
| PFHxA and its salts | 25 ppb | 0.025 mg/kg, as a sum |
| PFHxA-related substances | 1,000 ppb | 1 mg/kg, as a sum |
Two details decide how a test is scoped, and both are routinely missed:
- The basis is the homogeneous material, not the finished product. A cream in a coated carton is more than one material for this purpose, and each has to be judged on its own. Averaging across a composite sample dilutes the result and produces a report that answers a different question from the one a buyer is asking.
- The two sums are separate lines. A report that gives a single fluorinated-substance figure, or that covers PFHxA only, does not evidence compliance with the entry. The related-substances sum is the wider net and the one that fails first in practice.
Because the limits work in parts per billion, analysis is a specialist exercise. Nothing in this article substitutes for a competent laboratory's scope, and the practical value of knowing the two sums is that you can specify the right test instead of accepting the nearest available one.
Why "we never added PFAS" is not an answer
Brands are usually telling the truth when they say no fluorinated ingredient appears on the formula. The restriction is not written as a prohibition on intentional addition, and the routes below are why innocent formulas still need evidence:
- Replacement chemistry that is now captured. The C6 fluorotelomer family introduced as a substitute for earlier chemistry in coatings and treatments is precisely what the related-substances definition reaches. An ingredient chosen as a compliant replacement can still fall inside the second sum.
- Residues from shared equipment. Fluorinated processing aids used elsewhere on the same lines are a route that a formula audit does not see, and at ppb thresholds neither does a visual inspection.
- Residues in purchased intermediates. Where an ingredient's own supply chain involves fluorinated processing, the residue travels with the ingredient. Only documentation that reaches past the distributor can answer for it.
- Packaging-side exposure. Greaseproof and moisture-barrier treatments on cartons, sleeves and labels are a recognised route, which is why a complete file covers the pack as well as the fill.
The honest position for a brand is therefore that compliance lives in the documentation chain, not in the mixing vessel. This is the same pattern that governs every modern compliance file, and it is the reasoning behind the batch document set that should travel with the goods — the certificate of analysis and batch record pack is where a declaration chain becomes auditable.
The date ladder, so you can see what is still ahead
Cosmetics are an early category in a sequenced restriction, not the last one. The dates that matter for planning, in order:
- 10 October 2024 — the entry entered into force, beginning a 24-month transition.
- 10 April 2026 — firefighting foam for training, testing and public fire services.
- 10 October 2026 — cosmetic products, plus clothing textiles, footwear, food-contact paper and board, and consumer mixtures.
- 10 October 2027 — textiles, leather, furs and hides in non-clothing products for the general public.
- 10 October 2029 — firefighting foam for civil aviation.
For a beauty brand, the third line is the one that has passed. The rest matter for supply-chain questions: if a raw material or component is also used outside cosmetics, its producer is running a longer compliance calendar, and their documentation timetable may not match yours.
Separately, the picture is not uniform across Europe. Great Britain has not adopted an equivalent restriction at the date of writing while being covered by the persistent-organic-pollutant limits, and the bloc-wide PFAS restriction proposal — which would reach much further and names cosmetics among the uses with no proposed derogation — remains under committee review with no fixed application date. National rules already exist as well; the French PFAS law in force since 1 January 2026 is the first national cosmetics ban of its kind.
What to ask your formulator and your suppliers
Four questions separate a documented position from an optimistic one:
- Can you produce declarations that name the substance group, not the product family? A dated declaration covering the exact grade purchased is evidence. A statement that a supplier's range is PFAS-free is not.
- How far down the chain does your supplier qualification reach? Ingredient manufacturer, or distributor only? The residue routes live upstream of the distributor.
- What happens when a declaration changes? A documented trigger that launches a formula impact review is what keeps the file live rather than frozen at the launch date.
- Do your packaging specifications state the coating requirement? For a carton or sleeve, the specification either says something about fluorinated coatings or it is silent — and silence is the finding.
One question is worth adding for any brand selling beyond the EU: which of the affected categories does this substance sit in for the other markets you ship to? Several US states prohibit intentionally added PFAS in cosmetics, with effective dates that began in 2025 and continued into 2026, and the compliance logic there turns on intentionally-added versus trace presence. That is a different test from the EU ppb sums, and a single formula cannot assume one answer covers both.
The mistake that costs a season
The most expensive error is treating this as a France-shaped problem. France banned PFAS in cosmetics under national law first, and it is tempting to conclude that the only work required is the work the French decree described. It is not: the EU entry that took effect on 10 October 2026 uses a different structure, names a specific substance family, works at ppb level on homogeneous materials, and reaches C6 replacement chemistry that a "no intentional PFAS" formula would pass over.
The second mistake is testing the finished product. For a cream in a printed carton with a coated label, a "product" test is an ambiguous request. Scope the materials, ask for both sums, and keep the report with the specification it belongs to.
If you want the file to hold up in a customer audit, build it in this order: substance-family declaration per raw material, homogeneous-material test where a declaration is unavailable, a written statement about the pack coating, and a retained copy of all three against the batch. Then put a review date on it, because the next row of the date ladder is only a year away.
FAQ
Q: What are the PFHxA limits for cosmetics in the EU? A: Cosmetic products placed on the EU market from 10 October 2026 may not contain PFHxA and its salts at 25 ppb or more, or PFHxA-related substances at 1,000 ppb or more. The two thresholds are assessed separately, as sums, on the homogeneous material.
Q: My formula contains no fluorinated ingredient — do I still need evidence? A: Yes. The restriction is not limited to intentional addition. C6 replacement chemistry falls within the related-substances definition, and residues can arrive from shared processing equipment, from purchased intermediates and from coated packaging. Evidence means current, substance-specific declarations or a laboratory result scoped to the right material.
Q: Does the restriction apply to packaging as well as the formula? A: The entry restricts the cosmetic product, and coated cartons, sleeves and labels are a recognised route for fluorinated chemistry. Greaseproof and moisture-barrier treatments are the usual suspects, so a complete file states a coating requirement for the pack as well as a declaration position for the fill.
Q: Is this the same as the French PFAS ban? A: No. France acted under national law with its own thresholds and a transition for pre-existing stock, while the EU entry is a chemicals restriction naming the PFHxA family with two ppb-level sums and a homogeneous-material basis. A formula cleaned up for one route has not automatically been tested against the other, and both may apply to the same shipment.