Cosmetics Regulation EC 1223/2009: What Changed in 2026

Regulation (EC) No 1223/2009 is the backbone of cosmetics regulation in the European Union. It covers everything from safety assessments and ingredient restrictions to labelling, claims, and market surveillance. Since its original adoption, the regulation has been amended dozens of times through annexes updates, delegated acts, and implementing regulations. 2026 brings a particularly significant wave of changes that affect formulation, notification, claims, and labelling.

Here are the five changes that matter most for cosmetics brands operating in or exporting to the EU market.

1. PFAS Restrictions

What changed

The Commission has adopted restrictions on 30 per- and polyfluoroalkyl substances (PFAS) used in cosmetic products, adding them to Annex II (list of prohibited substances). This follows the broader ECHA PFAS restriction proposal and targets specific PFAS compounds that have been identified in cosmetic formulations, including certain fluorinated polymers used in long-wear foundations, waterproof mascaras, and sunscreen film-formers.

The restricted substances include PFOA, PFOS, PFHxS, and 27 additional fluorinated compounds that have been identified as persistent, bioaccumulative, or toxic. Products containing these substances above trace-level thresholds may no longer be placed on the EU market.

Compliance deadline

The restriction takes effect on 31 December 2026. Products placed on the market before that date may continue to be sold until their expiry, but no new batches containing the restricted substances may be manufactured or imported after the deadline.

What brands should do

• Audit every formulation for PFAS-containing ingredients — check raw material safety data sheets and request specific PFAS declarations from ingredient suppliers.
• Identify PFAS-free alternatives for affected ingredients, particularly fluorinated film-formers and water-repellent agents.
• Update Product Information Files (PIFs) and safety assessments to reflect reformulated products.
• Plan production transitions so that final batches of affected products are manufactured before the cutoff date.

2. Nanomaterial Definition Update

What changed

The definition of "nanomaterial" under the Cosmetics Regulation has been aligned with the Commission's updated Recommendation on nanomaterials. The key change is the 1% number-size threshold: a material is now classified as a nanomaterial if 1% or more of its particles (by number) have at least one external dimension in the 1-100 nm range. This replaces the previous 50% threshold that was referenced in earlier guidance.

This lower threshold means that more materials now fall within the nanomaterial classification, triggering additional notification, safety assessment, and labelling obligations under Article 16 of the regulation.

Impact on brands

Ingredients that were previously below the nanomaterial threshold may now be classified as nanomaterials. This particularly affects:

• Titanium dioxide and zinc oxide in sunscreens — many grades contain a fraction of nano-sized particles that now crosses the 1% threshold.
• Silica and iron oxides used as colorants and texture modifiers.
• Carbon black used in mascara and eyeliner formulations.

For each newly classified nanomaterial, brands must submit a nanomaterial notification to the Commission (via CPNP) six months before placing the product on the market, include "[nano]" after the ingredient name on the label, and ensure the safety assessment specifically addresses nano-specific exposure and toxicity considerations.

3. CPNP Expanded Fields

What changed

The Cosmetic Products Notification Portal (CPNP) has been updated with expanded mandatory fields. Three additions are particularly significant:

Fragrance allergens

The CPNP now requires brands to declare individual fragrance allergens present in the product, aligned with the expanded allergen list under Annex III. Previously, fragrance allergens were only required on the physical label; now they must also be declared in the CPNP notification. This includes the 56 fragrance allergens that were added to the mandatory declaration list, up from the original 26.

Label images

Brands are now required to upload label images (front and back panel) as part of the CPNP notification. Previously, label images were optional. This change allows poison centres and market surveillance authorities to verify that the physical label matches the notified data without needing to obtain a physical sample.

Responsible Person verification

The CPNP now includes a verification step for the Responsible Person (RP) designation. When a brand nominates an RP, the RP must confirm the designation within the portal. This prevents situations where brands list an RP without that person's knowledge or consent — a compliance gap that market surveillance authorities had flagged repeatedly.

4. Claims Substantiation

What changed

A new Article 20a has been introduced, strengthening the requirements for cosmetic claims substantiation. The article codifies and extends the principles that were previously contained only in the non-binding Common Criteria for Claims (Regulation 655/2013) and associated guidance.

Key requirements under the new article:

• Mandatory technical dossier: Every claim made on a cosmetic product must be supported by a technical dossier that is available to competent authorities upon request. The dossier must include the study protocol, results, statistical analysis, and conclusions.
• Study standards: Claims supported by clinical or instrumental studies must follow recognised methodological standards (such as those published by EEMCO or COLIPA/Cosmetics Europe). Home-use tests and consumer perception surveys are accepted for subjective claims but must meet minimum sample size requirements (now set at n=30 for consumer studies).
• Environmental claims: Claims related to environmental impact (biodegradable, ocean-friendly, carbon neutral) now require substantiation against specific criteria defined in a forthcoming delegated act. Generic environmental claims without specific, verifiable evidence are prohibited.
• Digital and social media claims: The regulation now explicitly applies to claims made in digital marketing and social media, not just on-pack labelling. Influencer content making product claims must be substantiated to the same standard as on-pack claims.

5. Digital Labelling

What changed

The regulation now formally permits digital labelling via QR code for certain mandatory information that does not fit on the physical label. This is particularly relevant for small-format products (travel sizes, sample sachets, lip products) where physical label space is extremely limited.

Under the new provisions:

• The QR code must link to a product-specific landing page containing the mandatory information. Generic brand pages are not sufficient.
• The landing page must be accessible without requiring app installation, account creation, or payment.
• The page must be maintained for the full shelf life of the product plus 12 months.
• Certain information — the product name, the RP's name and address, the country of origin for imported products, and the PAO/expiry date — must always remain on the physical label. Only supplementary mandatory information (full ingredient list, warnings, usage instructions) may be moved to the digital label.
• The QR code must be accompanied by the text "Full product information" (in the language(s) of the member state) to inform consumers of what they will find by scanning.

Practical implications

Digital labelling solves a genuine space problem for small-format products, but it introduces new data management challenges. Brands must now maintain digital landing pages for every SKU, ensure those pages are updated whenever the formulation or regulatory information changes, and manage the QR code generation and link integrity across potentially thousands of products.

Implementation Timeline

What This Means for Your Business

The 2026 amendments represent the most significant update to the Cosmetics Regulation since its original adoption. They affect every function in a cosmetics business: R&D must reformulate, regulatory affairs must re-notify, marketing must re-substantiate claims, packaging must accommodate QR codes, and IT must build and maintain digital labelling infrastructure.

The brands that will navigate this smoothly are those with centralised, structured product data — ingredient lists, regulatory classifications, claims evidence, label content, and notification data all managed in a single system. When a regulatory change affects an ingredient, you need to instantly identify every product containing that ingredient, assess the impact, and trigger the reformulation and re-notification workflow.

Regulatory change is constant. The cost of non-compliance is high. The only sustainable approach is a system that makes compliance the default, not the exception.

Artyql helps cosmetics brands manage exactly this — product data, regulatory compliance, and the workflows that connect them. If these 2026 changes affect your portfolio, we would be happy to show you how.

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