PFHxA in cosmetics 2026 – supplier declaration, 25/1,000 ppb, older stock and batch restrictions | Word/PDF/Excel

PFHxA in cosmetics 2026 – supplier certificates, laboratory tests, older stock and internal batch holds. From 10 October 2026, a special REACH restriction applies to cosmetic products, among others. For cosmetic manufacturers, importers and private label brands, the practical question is not just which substances are in the product – but whether relevant analytical data actually supports both PFHxA substance groups, whether a particular batch is covered by the transitional exemption and who is responsible for a decision on action.

Complete template package: Five Swedish work templates, one Swedish user guide and one separate English User Guide – all seven as editable Word documents and searchable A4 PDFs. Also an Excel register with nine tabs and 1,087 control formulas. Total 15 customer files in a digital ZIP. All documents have legal limitations and can be used without inventing laboratory or supplier values.

What does the new PFHxA restriction say?

Through Commission Regulation (EU) 2024/2462, a new entry 79 was introduced into Annex XVII to REACH Regulation (EC) 1907/2006. Point 1(e) of the entry applies to cosmetic products under Article 2.1(a) of Cosmetics Regulation (EC) 1223/2009. From 10 October 2026, affected cosmetic products may not be placed on the market or used at specified concentrations of PFHxA, its salts or PFHxA-related substances.

Threshold A: 25 ppb for the sum of PFHxA and its salts. Threshold B: 1,000 ppb for the sum of PFHxA-related substances. The concentrations apply to homogeneous material. Both thresholds include results that are exactly on the limit – the wording is “25 ppb or higher” and “1,000 ppb or higher”. A cosmetic batch may therefore need to be addressed even if only one of the sums reaches the relevant level.

PFHxA is not the same as all PFAS. The new entry refers to a defined group of PFHxA and PFHxA-related substances. Other restrictions, for example certain PFAS under the POPs Regulation, must be assessed separately. Packaging with a “PFAS-free” claim or an ingredients list is not automatically laboratory evidence of the two concentration sums.

Older cosmetic stock – what does the exemption mean?

REACH entry 79.7 states that the restriction in point 1 does not apply to affected goods and mixtures that were placed on the market before 10 October 2026. This does not mean that every product that was manufactured, labelled or held in internal stock before this date is automatically covered. A manufacturer or importer needs to be able to show the legally relevant first market placement, not just the manufacturing date.

Work template 04 distinguishes between manufacturing date, first release on the EU market, invoice/delivery evidence, stock date and onward distribution. If the market placement is unknown, it should be noted as not verified and reviewed manually. Do not create fictitious older order documents. A product that is imported or released after the start date may not be treated as older stock simply because it is older in production.

What should a useful supplier certificate contain?

This is not a government-issued PFHxA certificate. Instead, request a dated and traceable supplier response and underlying analytical report for the correct product, manufacturing lot and raw material composition. For a risk-based and useful decision-making basis, the company should check the analytical scope for both substance groups, laboratory, validated method, sample matrix, limit of quantification, measurement uncertainty and the document's references.

If a laboratory report shows <LOQ, it is not a measured value of zero. It is an analytical result below the reporting or quantification limit. If the method's detection capability, the range of analyzed substances or the sample matrix is insufficient, a low result may still need to be investigated. Templates 02 and 03 explicitly distinguish between data missing, evidence needs to be assessed and limit flag.

Which cosmetic companies are responsible?

According to Cosmetics Regulation (EC) 1223/2009, every cosmetic product on the EU market must have a responsible person within the EU/EEA. This can be the manufacturer, an importer or a private label company depending on the setup. The responsible person is responsible for product safety, safety assessment and Cosmetic Product Safety Report (CPSR), the product information file PIF and other cosmetic requirements, among other things. Distributors have their own, but partially different, obligations. The Swedish Chemicals Agency's guidance explains the division of roles.

This package is a complementary REACH basis. It does not make a complete cosmetic safety assessment, does not replace the PIF or CPSR, does not perform a CPNP registration and does not automatically calculate chemical risk. In case of suspected or confirmed non-conformance, the responsible person and affected distributors should assess the need for corrective actions, information to authorities and any other obligations.

All 15 files – document by document

The five Swedish work templates are each an editable A4 page with two framed information boxes and fields for the responsible assessor's decision. The Swedish and English guides are two pages each. All PDFs are searchable and printable, but are not interactively fillable.

Excel – nine tabs and 1,087 formulas

Start: administrative overview and number of non-conformances. Products: SKU, cosmetic category, responsible person and lot. Suppliers: certificates, analytical references and substance scope. Tests: PFHxA/salts and PFHxA-related substances in two separate numerical ppb fields, original report and threshold warnings. Substance groups: check of analytical scope. Stock: relevant EU market date and supporting documentation. Decisions: manual assessor signature. Non-conformances: internal batch hold and follow-up. Sources: EU and Swedish primary sources.

The following statuses can be displayed: ”BELOW THRESHOLDS – MANUAL REVIEW”, ”LIMIT FLAG – MANUAL REVIEW”, ”MISSING TEST REPORT”, ”OLDER – MISSING EVIDENCE” and ”INTERNAL HOLD”. The formulas have been tested with fictitious values that are no longer in the customer workbook. The mathematical limit check never replaces an actual assessment of the laboratory method, substance definition, transitional rule or the safety of the cosmetic.

Four realistic examples

1. Skin cream with verified 24 ppb PFHxA/salts and 600 ppb related: the values are below the respective new thresholds but this does not automatically mean that all applicable regulations and the product's safety documentation are met. Document manual check.
2. Foundation with exactly 25 ppb PFHxA/salts: the REACH threshold is reached. Internal hold and specialist assessment may be needed even if PFHxA-related substances are low.
3. Hair product with exactly 1,000 ppb PFHxA-related: the other threshold is also reached. Investigate substance selection, the laboratory's method and the responsible person's actions.
4. Older lipstick, manufactured August 2026: actual delivery details are missing. The fact that the product was manufactured before October 10 does not in itself support that it has already been lawfully placed on the EU market. Register the exemption as not verified.

Workflow – six steps

1. Identify cosmetic product, brand, SKU, batch, manufacturer, importer and who is the responsible person within the EU/EEA.
2. Inventory raw materials and relevant supplier evidence without treating INCI or “PFAS-free” as a general analytical response.
3. Request and check the original report's two PFHxA sums, homogeneous sample matrix, laboratory method, LOQ and measurement uncertainty.
4. For older stock: document when the good was actually first placed on the EU market and retain relevant invoice/delivery evidence.
5. If uncertainty or suspected limit exceedance exists: create internal batch hold, assign responsible person and request the right supplement or expert review.
6. Manually register decision and CAPA, and ensure the responsible person assesses the other obligations of the cosmetics regulations including PIF/CPSR if needed.

Frequently asked questions

When did the new PFHxA rule start applying to cosmetics?

October 10, 2026 according to point 1(e) in REACH Annex XVII entry 79 through EU 2024/2462. It is a directly applicable EU restriction.

What are the limit values for PFHxA in cosmetics?

25 ppb for the sum of PFHxA and its salts and 1,000 ppb for the sum of PFHxA-related substances, measured in homogeneous material. The restriction includes values that are equal to or higher than the respective limit.

Can I use a general PFAS-free certificate from the supplier?

Not as an automatic replacement for relevant substance and analytical evidence. Check that the substance selection, batch, sample matrix, method and reporting limits actually support the applicable requirements.

Does every cosmetic batch need to be laboratory tested?

This product does not claim that REACH entry 79 generally requires laboratory testing of every individual batch. The company must have sufficiently reliable and relevant basis for its legal and safety assessment. Scope and test strategy are determined risk-based and after expert assessment.

Does the ban also apply to cosmetics manufactured before October 2026?

There may be an exemption for products that were actually placed on the market before 10 October 2026. Manufacturing date alone is not evidence of first release on the EU market.

Does this only apply to makeup or also shampoo and skin cream?

The provision applies to cosmetic products as a category according to the cosmetics regulation's definition. It is not a specific rule just for a certain INCI list or a certain cosmetic product form.

Is the Excel status “below thresholds” enough to approve a product?

No. Excel only calculates administrative signals based on manually entered numbers. It does not decide method selection, measurement uncertainty, chemical substance definitions or compliance with other EU regulations.

Is it a complete CPSR, PIF or CPNP application?

No. The package complements such documents and provides no complete safety basis or direct authority integration.

Are all work templates translated into English?

No. Five work templates and Excel are Swedish. A separate English User Guide is included, and all seven documents are available as Word and searchable PDF.

Has a lawyer or a laboratory approved the documents?

No. They have AI-assisted legal review dated November 12, 2026, but no independent lawyer, accredited laboratory or authority has approved the product.

Related products in the Template Store

For PFHxA in another sector, see PFHxA in clothing and shoes 2026. For another type of chemical restriction in cosmetics, see REACH microplastics in shampoo and shower gel 2027. For cosmetic labelling, see Fragrance allergens and INCI labelling. This product specifically refers to PFHxA in cosmetics from October 2026 and documentation of limit values, analytical evidence and older stock.

Official legal sources

Commission Regulation (EU) 2024/2462; REACH (EC) 1907/2006, Annex XVII entry 79; Cosmetics Regulation (EC) 1223/2009; Swedish Chemicals Agency's PFHxA guidance and Swedish Chemicals Agency's cosmetics guidance.

Version 1.0. AI-assisted source review November 12, 2026. No independent legal, toxicological or laboratory review has been performed. These templates are not official declarations, laboratory certificates, CPSR, PIF, an authority decision or guarantee of compliance. Check original data and current legal text before actual use. The product is unpublished until the store administrator decides otherwise; digital ZIP needs to be linked to the delivery system separately.

Related specialist guide: PFHxA in cosmetics – 2026 limits, supplier evidence and older EU stock. Read about the rules and practical checks before using these templates.