PFHxA in cosmetics – 2026 limits, supplier evidence and older EU stock
A guide for cosmetic manufacturers, importers and private-label brands on REACH PFHxA thresholds, laboratory evidence and old stock.
Short answer: From 10 October 2026, REACH Annex XVII entry 79 paragraph 1(e), added by Regulation (EU) 2024/2462, restricts cosmetics at 25 ppb or more for the sum of PFHxA and its salts, or 1,000 ppb or more for the sum of PFHxA-related substances, in homogeneous material. Either threshold independently matters. Cosmetics actually first placed on the EU market before that date may qualify for the paragraph 7 transition. A supplier's bare “PFAS-free” claim does not establish both sums.
What changed for cosmetics on 10 October 2026?
Cosmetics are defined in Regulation (EC) 1223/2009 and can include skincare, shampoo and makeup. Identify the actual legal product category and composition. PFHxA entry 79 does not cover every PFAS and does not override stricter POPs or other cosmetics restrictions.
Two distinct PFHxA concentration thresholds
The first sum covers PFHxA and its salts; the second the PFHxA-related substances defined by molecular structure. Both thresholds are independent and readings exactly at the level are covered. Check analyte scope, homogeneous sample matrix, units, LOQ, uncertainty and summing method. A result <LOQ is not a proven zero. Entry 79 does not impose a general new laboratory test for every individual lot, but product decisions need reliable supporting evidence.
Decision table: laboratory reports and historic stock
| Documented situation | Assessment and next check |
|---|---|
| Lab reports PFHxA/salts 24 ppb and related substances 900 ppb | Below both numerical thresholds if analyte coverage, method and uncertainty are reliable; no automatic full product approval. |
| Lab reports exactly 25 ppb PFHxA/salts | The first threshold has been met. Record the issue and require responsible-person review regardless of the second sum. |
| Lab reports exactly 1,000 ppb related substances | The second threshold is reached even if PFHxA/salts are low. Validate the relevant analyte sum. |
| Only a general “PFAS-free” supplier declaration | Insufficient as a sole laboratory assessment. Request analyte lists, sample matrix, method, LOQ, batch reference and date. |
| A substance is shown as <LOQ | This does not equal a proven zero. Ask how incomplete measurements affect the reported sum. |
| Manufactured before October but first supplied in the EU later | Manufacture date alone does not prove first placing on the EU market before the deadline. |
Who is responsible for cosmetic compliance?
Every cosmetic product requires a designated EU/EEA responsible person under Regulation 1223/2009. The manufacturer, importer or private-label brand may be that person depending on the real chain. Distributors have separate duties and may acquire the role if they market under their own brand or alter products in relevant ways. The responsible person must address the Cosmetic Product Safety Report (CPSR), Product Information File (PIF) and relevant CPNP notifications. PFHxA controls supplement but cannot replace these requirements.
Six steps for evidence and batch decisions
- Identify the product, brand, SKU, lot, manufacturer, importer, distributor and actual EU/EEA responsible person.
- Map ingredient suppliers and request dated, traceable information about both PFHxA sums for the relevant cosmetic formulation or batch.
- Check original lab evidence: analyte list, homogeneous matrix, tested sample, units, method, LOQ and measurement uncertainty. Query incomplete reports.
- Separate manufacturing, purchase, import and first EU market-placement dates; require real delivery, sales and distribution evidence before invoking paragraph 7.
- Where evidence is missing or the threshold may be reached, consider a documented internal lot hold pending qualified responsible-person assessment.
- Log the decision, corrective actions and links to CPSR/PIF/CPNP where relevant; never invent laboratory facts or automatically clear a batch.
Two import and private-label scenarios
Case A – late import: A skin cream was made outside the EU in August 2026 but is first imported and placed on the EU market in November. Manufacturing date alone does not establish the transition exemption.
Case B – private label: A foundation supplier only offers an unspecific 'PFAS-free' statement. The brand's responsible person must assess whether additional proof is needed; entry 79 does not automatically require fresh testing of every individual batch.
Frequently asked questions
Is laboratory testing legally required for each batch?
Entry 79 does not state a blanket requirement for a new laboratory test on every batch. Evidence still needs to be sufficient for the specific decision.
Does exactly 25 ppb breach the numerical threshold?
Yes. The language is equal to or greater than 25 ppb for PFHxA/salts and 1,000 ppb for related substances.
Is pre-October manufacturing proof of older stock?
No. The exception concerns actual first placement on the EU market before 10 October 2026.
Does this guide replace CPSR, PIF or CPNP?
No. It helps document the separate PFHxA REACH restriction, not comprehensive cosmetic compliance.
Official sources and limitations
law · reach · cosmetics · kemi · lmv
Editorial source review 13 November 2026. General EU rules with Swedish authority context; not legal certification, laboratory testing, CPSR, PIF or product clearance.
Practical Word, PDF and Excel templates
For editable supporting documents, see PFHxA in cosmetics 2026 – supplier declaration, 25/1,000 ppb, older stock and batch restrictions | Word/PDF/Excel. Check the product page for the exact included files.
