Which specific changes to the EU Cosmetics Regulation take effect in 2026?

Several changes take effect in parallel in 2026: from 1 May 2026 new CMR substance bans apply under the Omnibus VIII Regulation (EU) 2026/78, from 6 June 2026 the ban on cyclosiloxanes (D4, D5, D6) in rinse-off products, from 31 July 2026 the extended fragrance allergen labelling covering 80 substances, and from 10 October 2026 the PFAS ban (PFHxA) in cosmetics. In addition, from 30 July 2026 the updated INCI glossary with 348 new entries becomes mandatory.

What is the role of the Responsible Person in the 2026 changes?

The Responsible Person under Art. 4 of EU Regulation 1223/2009 bears sole legal responsibility for ensuring that all changes are implemented on time. They must review formulations, update the PIF, submit amended CPNP notifications and ensure that labelling is adapted. In contract manufacturing, responsibility remains with the client as the Responsible Person, not with the contract manufacturer.

Do I have to update my CPNP notification because of the 2026 changes?

Yes, if the regulatory changes alter the composition of your product (e.g. replacing a prohibited CMR substance) or the labelling is updated (e.g. new fragrance allergens). Art. 13(3) of EU Regulation 1223/2009 requires the Responsible Person to notify changes in the CPNP without delay. Purely formal changes such as the updated INCI glossary require the labelling to be updated but do not necessarily require a new CPNP notification, provided the INCI names do not change.

Do the changes to the EU Cosmetics Regulation also apply in Switzerland?

Switzerland has largely adopted the EU Cosmetics Regulation 1223/2009 through the Ordinance on Foodstuffs and Utility Articles (LGV). Changes to the EU annexes are usually transposed into Swiss law with a time lag. Manufacturers selling in both the EU and Switzerland should follow the EU deadlines, as these generally take effect first.

What happens if I miss the deadlines?

Products that are not compliant after the respective cut-off date may no longer be placed on the market or made available on the market. Depending on the Member State, breaches can lead to fines, recalls or sales bans. In Germany the BVL (Federal Office of Consumer Protection and Food Safety) is responsible, in Austria the AGES and in Switzerland the BAG. Market surveillance authorities are increasingly carrying out spot checks on conformity.

EU Cosmetics Regulation 2026: What Manufacturers Must Know

Q: Does the Cosmetics Regulation 2026 also affect existing products or only new products?

Most of the changes also affect existing products. The Omnibus VIII Regulation (EU) 2026/78 applies from 1 May 2026 without a transition period: products containing prohibited CMR substances may no longer be placed on the market from this date. For the extended fragrance allergen labelling, by contrast, there is a sell-off period: new products must be compliant from 31 July 2026, while products already on the market only from 31 July 2028.

In 2026, cosmetics manufacturers in the DACH region face an unusual density of regulatory changes. New CMR substance bans, extended fragrance allergen labelling, cyclosiloxane restrictions and PFAS bans take effect in quick succession — each with its own deadlines, affected annexes and conformity requirements.

The foundation remains the EU Cosmetics Regulation (EC) No 1223/2009, which has provided the legal framework for cosmetic products in the EU since 2013. What is changing are above all the annexes: substance bans (Annex II), restrictions (Annex III) and approved UV filters, preservatives and colourants (Annexes IV–VI). Added to this are changes from the REACH Regulation, which likewise affect cosmetic formulations.

This guide draws a clear distinction between confirmed requirements, ongoing developments and organisational best practices. You will learn which deadlines are binding, what your company should now specifically review and how structured documentation processes help you implement regulatory changes reliably.

Legal notice

This article provides professional guidance and does not constitute legal advice. For binding information on your specific case, consult a law firm specialising in cosmetics law or your competent authority.

Overview: what changes in the Cosmetics Regulation in 2026

Unlike in previous years, several regulations with different effective dates coincide in 2026. The following timeline shows the key dates for the DACH region:

Date	Regulation	Change
01.05.2026	(EU) 2026/78 — Omnibus VIII	New CMR substance bans and restrictions in Annexes II, III, V
06.06.2026	(EU) 2024/1328	Cyclosiloxanes D4, D5, D6 banned in rinse-off products (≥0.1 %)
30.07.2026	INCI glossary update	Updated glossary with 348 new entries becomes mandatory
31.07.2026	(EU) 2023/1545	Extended fragrance allergen declaration (80 substances) for new products
10.10.2026	REACH — PFHxA restriction	PFAS ban (PFHxA <25 ppb) in cosmetics

In parallel, the official evaluation of the Cosmetics Regulation by the European Commission runs from mid-2025 to mid-2026. It examines whether the Regulation in its current form is still fit for purpose — among other things on the topics of sustainability, digitalisation and nanomaterials. A fundamental revision of the Regulation has not been decided at present, but could result from this evaluation.

CMR substance bans: Omnibus VIII (EU) 2026/78 from May 2026

Commission Regulation (EU) 2026/78 of 12 January 2026 implements the eighth omnibus amendment (Omnibus VIII) of the Cosmetics Regulation. It concerns substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under the CLP Regulation.

What is changing specifically

Annex II (prohibited substances): New entries for substances such as perboric acid, silver (nano form) and carbon nanotubes. Acetone oxime (CAS 127-06-0) has also been classified as CMR 1B and is thereby prohibited.
Annex III (restricted substances): Hexyl salicylate (hexyl 2-hydroxybenzoate) receives product-specific maximum concentrations. Silver (powder) is limited to a maximum of 0.05 % in toothpaste and mouthwash.
Annex V (preservatives): Adjustments to o-phenylphenol with updated concentration limits.

No transition period

The Omnibus VIII Regulation applies from 1 May 2026 with no exceptions and no sell-off period. Non-compliant products may no longer be placed on the market from this date. Remaining stock must be sold off beforehand.

Organisational best practice: Now systematically check all formulations for the affected substances. A complete reconciliation of the raw material specifications with the updated annexes is the first step. Document the review process — this helps with the next audit.

Extended fragrance allergen labelling from July 2026

Regulation (EU) 2023/1545 extends the list of fragrance allergens subject to mandatory declaration from 26 to 80 substances. The aim is better primary and secondary prevention of contact allergies. The thresholds for the declaration obligation remain in place:

Leave-on products: declaration from >0.001 % (10 ppm)
Rinse-off products: declaration from >0.01 % (100 ppm)

Timeline and transition periods

From 31 July 2026: New products placed on the market for the first time must be compliant.
From 31 July 2028: Products already on the market must also carry the extended declaration.

For manufacturers, this specifically means: every fragrance raw material (fragrance oil, essential oil, individual fragrance ingredient) must be checked against the new 80 allergens. The suppliers' specification data sheets are the central data source — and may need to be requested or updated where necessary.

Correct declaration requires a complete breakdown of all fragrances down to INCI individual-ingredient level. How this works in practice is described in our guide to creating an INCI list.

Cyclosiloxanes and PFAS: further substance bans in 2026

Cyclosiloxanes (D4, D5, D6)

Regulation (EU) 2024/1328 prohibits the cyclosiloxanes D4 (octamethylcyclotetrasiloxane), D5 (decamethylcyclopentasiloxane) and D6 (dodecamethylcyclohexasiloxane) in cosmetic products where the concentration is ≥0.1 %. The timeline is staggered:

Rinse-off products: ban from 6 June 2026
Leave-on products: ban from 6 June 2027

D5 is present in many hair care and skin care formulations as a texturising agent and volatile silicone oil. Manufacturers should check whether their raw materials contain these siloxanes — including as impurities in silicone blends.

PFAS (per- and polyfluoroalkyl substances)

Via the REACH Regulation, a ban on PFHxA and related compounds in cosmetics takes effect from 10 October 2026. The limit value is 25 ppb. In cosmetics, PFAS are found above all in long-lasting make-up products, sunscreens and water-repellent formulations.

A common misconception

The PFAS ban does not come from the Cosmetics Regulation itself, but via the REACH Regulation. It nonetheless applies directly to cosmetic products. Manufacturers must keep both frameworks in view.

The Responsible Person and current CPNP notification obligations

Art. 4 of the EU Cosmetics Regulation defines the Responsible Person (RP) as the central legal entity. It bears the responsibility for ensuring that every product meets the applicable requirements — including all the changes taking effect in 2026.

Obligations in the event of regulatory changes

Formulation review: Check all formulas for prohibited or newly restricted substances
PIF update: The Product Information File must reflect the current state of the formulation, safety assessment and labelling
CPNP notification: When formulations change, an update in the Cosmetic Products Notification Portal is required (Art. 13 EU Regulation 1223/2009)
Labelling: Labels must reflect the updated declaration obligations

Important for contract manufacturers: Even if a contract manufacturer physically produces the product, the Responsible Person (usually the client / brand owner) remains legally responsible. Who documents what should be clearly set out in the contract.

Practical examples: what manufacturers should do now

Example 1: shampoo with cyclosiloxane D5

A mid-sized manufacturer produces a volumising shampoo that contains D5 (decamethylcyclopentasiloxane) as a texturising agent. As shampoo is a rinse-off product, the ban applies from 6 June 2026.

Specific steps:

Check the raw material specification: does the silicone raw material contain D5 ≥0.1 %? Including as an impurity?
Test an alternative formulation with a siloxane-free silicone replacement (e.g. dimethicone or plant-based alternatives)
Carry out new stability and compatibility tests
Have the safety assessment (CPSR) updated
Update the PIF, amend the CPNP notification, print new labels
Sell off remaining stock with the old formulation before 6 June

Example 2: face cream with a new fragrance oil

A natural cosmetics manufacturer wants to launch a face cream with a new fragrance oil in September 2026. The fragrance oil contains 14 individual fragrance ingredients, 5 of which are on the extended allergen list.

Specific steps:

Request the complete INCI breakdown with concentration data from the fragrance supplier
Check whether the 5 allergens in the final formulation exceed the thresholds (>0.001 % for leave-on)
Create the INCI list with all allergens subject to mandatory declaration
Design the label with the updated declaration
Submit the CPNP notification with the correct frame formulation

As the product is placed on the market for the first time after 31 July 2026, it must meet the extended 80-substance declaration from the outset.

Both examples show that the regulatory changes affect not only the formulation but run through the entire documentation chain — from the safety assessment through the PIF to the CPNP notification and labelling. Mapping these processes in a structured way avoids gaps and saves time at the next audit.

Checklist: implementing the Cosmetics Regulation 2026 reliably

Regulatory checklist 2026

Check all formulations for CMR substances banned from 1 May 2026 (Annex II, Omnibus VIII)
Check cyclosiloxane levels (D4, D5, D6) in rinse-off products — ban from 6 June 2026
Extend the fragrance allergen declaration to 80 substances — new products compliant from 31 July 2026
Identify PFAS-containing ingredients — PFHxA ban from 10 October 2026
Use the updated INCI glossary in all labelling from 30 July 2026
Update the Product Information File (PIF) for every affected product
Amend CPNP notifications without delay when formulations change
Amend labels and packaging in good time — allow for print lead times
Secure documentation of all changes for the next audit
Check supplier specifications against new limit values and purity criteria

For structured implementation it helps to manage formulations, batch records and PIF documents centrally — this makes it easy to identify affected products quickly, document changes and archive audit evidence without gaps. How a good PIF should be structured is described in our PIF practical guide. The GMP documentation requirements under ISO 22716 are explained by the GMP guide for cosmetics.

Further resources

Creating a PIF — guide & template

The 5 mandatory components of the Product Information File under Art. 11 EU Regulation 1223/2009.

GMP for cosmetics under ISO 22716

Documentation, batch records and audit preparation — the complete guide.

Creating an INCI list correctly

Nomenclature, ordering rules and common mistakes in the ingredient declaration.

EU Cosmetics Regulation 2026: What Manufacturers Now Need to Know