Nanomaterials in Cosmetics How to Audit and Label Ingredients
Cosmetics
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Anagha

Cosmetic toxicologist at Euverify, specialising in cosmetic product safety, PIF and CPSR preparation, and regulatory compliance with EU and UK Cosmetic Regulations. Conducts toxicological assessments of cosmetic ingredients and formulations, reviews product safety reports and manages CPNP and SCPN product notifications. Dedicated to supporting brands in achieving compliance with EU and UK cosmetic standards.

Nanomaterials in Cosmetics: How to Audit and Label Ingredients Under the New EU Rules

Tiny particles can have enormous regulatory implications.

Nanomaterials have been used in cosmetics for years to enhance texture, absorption, and protection. But as science advances, so do the regulations that govern these materials. Regulation (EU) 2024/858 amends Annexes II and III of the long-standing Cosmetics Regulation (EC) 1223/2009. It bans listed nano forms of copper, gold, platinum, silver and styrene/acrylates, and restricts hydroxyapatite (nano). The definition, notification and labelling rules for nanomaterials come from the Cosmetics Regulation itself.

For cosmetic brands, these updates mean it’s no longer enough to assume compliance. Ingredient data, product safety documentation, and labels all need to align with the new definitions and technical requirements.

This guide walks you through how to audit your formulations, label nanomaterials correctly, and keep your Product Information File (PIF) and Cosmetic Product Safety Report (CPSR) ready for inspection under the new EU rules.

The Evolving Regulatory Context

The Evolving Regulatory Context

The EU Cosmetics Regulation (EC) 1223/2009 has always required brands to assess ingredient safety and ensure transparency when using materials in nano form. Regulation (EU) 2024/858 did not change these requirements. It added specific nanomaterials to the banned list (Annex II) and the restricted list (Annex III), from 1 February 2025 for placing on the market and 1 November 2025 for making available.

The main nanomaterial rules in the Cosmetics Regulation are:

  • Definition of nanomaterial (Article 2(1)(k)): The term covers an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.

Example of nanoscale range (1–100 nm) under EU definition — comparing nano and non-nano particles.

  • Notification six months before launch: In addition to the normal CPNP notification, a cosmetic product containing nanomaterials must be notified to the Commission by the responsible person six months before it is placed on the market (Article 16(3)). This does not apply where the nanomaterials comply with Annex III, and nanomaterials used as colourants, UV filters or preservatives fall under Article 14 instead (Article 16(2)).
  • Reinforced safety evaluation: Each notification must include complete safety data, particle size characterisation, and a toxicological profile. If the Commission has safety concerns about a nanomaterial, it asks the Scientific Committee on Consumer Safety (SCCS) for an opinion.

Improved traceability and transparency: The Commission’s public catalogue of nanomaterials used in cosmetic products is updated regularly. It lists the product categories and reasonably foreseeable exposure conditions (Article 16(10)).

Together, these measures are designed to make sure nanomaterials are both safe for consumers and properly identified at every stage of a cosmetic product’s lifecycle.

Why Size Matters in Cosmetics

Why Size Matters in Cosmetics

Source: The SCCS Guidance on the safety assessment of nanomaterials in cosmetics gets second update

Nanoparticles don’t always behave like their larger counterparts. At the nanoscale (1–100 nm), materials can develop new optical, chemical, or physical properties, such as greater transparency in sunscreens, increased surface activity, or different interactions with the skin.

This is exactly why the EU regulates nanoscale ingredients separately under Articles 2, 16 and 19 of the Cosmetics Regulation (EC) 1223/2009.

If a material is insoluble or biopersistent and still between 1 and 100 nm in the finished product, it must be labelled with “(nano)” and notified under Article 16. However, if it dissolves or otherwise no longer meets the definition during formulation, it may no longer fall under the “nano” definition, which changes the compliance requirements.

Why Many Cosmetic Brands Still Struggle Complying with Nanomaterials

Even established cosmetic brands continue to face challenges when it comes to complying with nanomaterial requirements:

  • Hidden nano ingredients: Some pigments, such as titanium dioxide, zinc oxide, carbon black, and silica, can exist in both conventional and nano forms. This makes supplier transparency absolutely essential.
  • Incomplete supplier data: Particle size information is often missing, inconsistent, or based on outdated testing methods.
  • “nano by accident”: Certain manufacturing processes, like milling, coating, or emulsification, can unintentionally create nanoscale materials.
  • Documentation gaps: Product Information Files (PIFs) and Cosmetic Product Safety Reports (CPSRs) often lack nano-specific exposure or toxicology data, which is one of the most common causes of non-compliance.

These issues make regular ingredient audits crucial. They help ensure compliance, maintain consumer safety, and prevent costly recalls or unwanted appearances in the EU’s public nanomaterial database.

How to Audit Your Ingredients for Nanomaterials

  1. Step 1 – Identify potential nanomaterials
    Start by reviewing your ingredient list for substances that are often manufactured in nano form, such as titanium dioxide, zinc oxide, silica, iron oxides, mica, carbon black, and UV filters.Check the EU Catalogue of Nanomaterials and SCCS opinions to confirm whether any of your ingredients are officially recognized as nano.
  2. Step 2 – Request technical data from suppliers
    Ask your suppliers to provide:
    • Particle-size distribution (using electron microscopy or dynamic light scattering)
    • Surface-area data (BET method)
    • Solubility and coating details
    • A toxicological dossier or SCCS reference

      Make sure this information reflects the ingredient’s final form in your formulation, not just the raw material.
  3. Step 3 – Update your PIF and CPSR
    In the Cosmetic Product Safety Report (CPSR), which is part of your Product Information File (PIF):
    • Part A (safety information) should include a full description of the nanomaterial, its physicochemical properties, and exposure conditions.
    • Part B (the safety assessment) must contain the toxicologist’s assessment of nano-specific endpoints such as skin penetration, inhalation, and long-term accumulation.
      All of this information should be traceable back to supplier certificates or SCCS safety assessments.
  4. Step 4 – Verify your CPNP notification
    When submitting your product in the Cosmetic Products Notification Portal (CPNP), select the “contains nanomaterials” option and upload the full documentation.Each nano ingredient must be listed using its INCI name followed by “(nano),” exactly as it appears on your product label and in your PIF.

EU & UK Nanomaterial Labelling Requirements: When to Use “(nano)”

  1. Under Article 19 of the EU Cosmetics Regulation, any ingredient used in nano form must be clearly indicated on the product label by adding “(nano)” immediately after its INCI name. The version of the Cosmetics Regulation that applies in Great Britain has the same wording in Article 19(1)(g).

    Example of correct labelling:
    Titanium Dioxide (nano), Zinc Oxide (nano), Silica (nano)
    Common mistakes to avoid:
    • Leaving out “(nano)” because the supplier did not provide particle-size information.
    • Labelling ingredients as nano when they actually dissolve in the final formulation, meaning they no longer have nanoscale properties.
    • Using inconsistent ingredient names across the label, PIF, and CPNP entry.

The example below shows how nanomaterial ingredients should appear on a cosmetic product label under EU rules — and how common mistakes can make a product non-compliant.

Why Size Matters in Cosmetics 1

REFERENCE: Regulation (EC) No 1223/2009, Article 19(1)(g) — “All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word ‘nano’ in brackets.”

Article 19(1)(g) writes the word as ‘nano’ in brackets, so write “(nano)” in lowercase after the ingredient name and use the same spelling on the label, in the PIF and in the CPNP entry.

This detail goes beyond formatting. Always verify how the material exists in your finished product and keep evidence to support it in your technical documentation. The Responsible Person should confirm this consistency before the product is placed on the EU market.

Strengthening Safety and Consumer Transparency in Nanomaterial Regulation

Beyond compliance, nanomaterial regulation is also about consumer trust. The European Commission’s public catalogue lists the nanomaterials used in cosmetic products on the market, with the product categories and reasonably foreseeable exposure conditions. SCCS opinions are published separately (Article 16(4)).

This level of transparency helps consumers make informed choices and reduces confusion or misinformation about nanotechnology. Brands that can clearly demonstrate the safe, responsible use of nanomaterials often see their credibility grow. In today’s beauty market, openness about science and safety is becoming just as important as sustainability.

Preparing for Inspections and Market Surveillance of Nanomaterial Compliance

Market-surveillance authorities across EU Member States can check nanomaterial compliance. Expect cross-verification between CPNP notification data, product labels, and information contained in your PIF and CPSR.

To prepare:

  • Keep complete test reports and safety evaluations readily available.
  • Ensure supplier certificates are traceable to batch numbers.
  • Update documentation whenever formulations, coatings, or raw-material suppliers change.
  • Monitor new SCCS opinions — ingredients already approved may later require updated safety assessments if new evidence arises.

Failure to maintain accurate nano documentation can result in enforcement action, product withdrawal, or public disclosure of non-compliance.

The Audit Advantage: Turning Compliance into Leadership

Market surveillance authorities across EU Member States can review nanomaterial compliance. They can cross-check data from CPNP notifications against product labels and the information in your PIF and CPSR, so consistency across all three is essential.

Euverify Insight: Simplifying Nanomaterial Compliance

At Euverify, we help cosmetic brands transform complex nanomaterial obligations into structured, verifiable documentation. Our experts:

  • Screen your ingredients for potential nanomaterials
  • Review supplier data and request missing particle-size or safety information
  • Prepare your PIF, with the CPSR written by a certified cosmetic safety assessor
  • Review labels and complete CPNP and SCPN notifications
  • Coordinate accredited lab tests for your PIF and CPSR

If your formulations may contain nanomaterials, even unintentionally, we can help you confirm and document them correctly. This helps you prepare for inspection.

Final Takeaway

The EU’s renewed focus on nanomaterials marks a clear shift from simple ingredient disclosure to evidence-based safety and transparency.

For cosmetic manufacturers, the message is straightforward: know your ingredients, verify your data, and keep your documentation complete.

Brands that act early by auditing formulations, updating labels, and strengthening their PIFs will not only stay compliant but also lead the way in a new era of traceable, science-driven beauty.