Nanomaterials in EU cosmetics: the definition, the [nano] label, Article 16 and the 2024 bans

• A nanomaterial has a specific legal definition in cosmetics — Art. 2(1)(k) of Regulation (EC) 1223/2009 — and a nanoform is never automatically interchangeable with its conventional counterpart.
• A product containing a nanomaterial triggers two notifications: the standard CPNP notification (Art. 13) and a dedicated six-month notification to the Commission (Art. 16), plus the mandatory [nano] suffix in the ingredient list (Art. 19(1)(g)).
• 2024 was a turning point: Regulation (EU) 2024/858 prohibited five nanomaterial groups and restricted one — the first large nano clean-up since the Regulation came into force.

1. What "nanomaterial" means in EU cosmetics

Regulation (EC) 1223/2009 is one of the few pieces of EU law with a binding, sector-specific definition of nanomaterial. Art. 2(1)(k) states:

"'nanomaterial' means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm."

Three elements matter. The material must be insoluble or biopersistant (it stays intact in the body), intentionally manufactured (incidental nanoscale fractions are not in scope), and have a dimension or internal structure in the 1–100 nm range.

There is also a broader, horizontal Commission Recommendation 2022/C 229/01 that updates the general EU definition of nanomaterial across sectors. It is worth knowing it exists — but it is non-binding guidance. The definition that governs a cosmetic product remains the one in Art. 2(1)(k), which has not been amended to match the Recommendation. When you assess whether an ingredient is a nanomaterial for cosmetics, Art. 2(1)(k) is the text that applies.

2. Two notifications, not one

This is the point most often misunderstood: a cosmetic product containing a nanomaterial is notified twice, under two different articles.

Art. 13 — the CPNP notification. Every cosmetic placed on the EU market is notified through the Cosmetic Products Notification Portal. Art. 13(1)(f) requires that this notification already include the presence of any nanomaterial, its identification (IUPAC chemical name and other descriptors) and the reasonably foreseeable exposure conditions. The full mechanics of this portal are covered in the guide on the CPNP.

Art. 16 — the dedicated nano notification. On top of the CPNP, the responsible person must notify the Commission separately and in advance when a product contains a nanomaterial. The two duties are cumulative — satisfying one does not satisfy the other.

3. Article 16 in detail: the six-month notification

Art. 16(3) sets out the core obligation:

"In addition to the notification under Article 13, cosmetic products containing nanomaterials shall be notified to the Commission by the responsible person by electronic means six months prior to being placed on the market […]."

The notification must include a defined dataset: the identification of the nanomaterial (IUPAC name and descriptors), its specification (particle size, physical and chemical properties), an estimate of the annual quantity placed on the market, the toxicological profile, the safety data for the relevant product category, and the reasonably foreseeable exposure conditions.

Two further mechanisms complete the regime:

• SCCS review (Art. 16(4)). Where the Commission has concerns about a nanomaterial's safety, it refers the substance to the SCCS for an opinion. This is the bridge between notification and regulation: a concern raised here is what eventually moves a nanomaterial onto a positive list — or into the prohibited list.
• The Catalogue (Art. 16(10)). The Commission maintains a publicly available catalogue of all nanomaterials used in cosmetic products, including those used as colorants, UV-filters and preservatives in a separate section. It is hosted via the EU Observatory for Nanomaterials and updated periodically.

4. The carve-out: nano colorants, UV-filters and preservatives

Not every nanomaterial goes through the Art. 16 six-month notification. Art. 16(2) provides a carve-out:

"The provisions of this Article do not apply to nanomaterials used as colorants, UV-filters or preservatives regulated under Article 14, unless expressly specified."

The logic is clean. A nano-colorant, nano-UV-filter or nano-preservative that is already listed in a positive list — Annex IV, Annex V or Annex VI — has already been through prior authorisation and SCCS assessment to get there. The six-month notification would be redundant. So the Art. 16 notification applies to novel nanomaterials and to nano functions that are not governed by a positive list; the Annex-listed nanoforms are governed by the conditions of their entry instead.

5. The [nano] label

Art. 19(1)(g) makes nanomaterials visible to the consumer:

"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."

In practice this means the INCI list shows entries such as "Titanium Dioxide [nano]" or "Carbon Black [nano]". The suffix is mandatory and is the single most visible signal that a formulation contains a nanomaterial — which is exactly why getting the nanoform status of an ingredient right at the formulation stage also fixes the label.

6. Authorised nanomaterials: the positive-list nanoforms

A handful of nanomaterials have passed SCCS assessment and are authorised under specific conditions. They sit in the positive-list Annexes, each as a separate entry from their conventional counterpart:

A recurring detail: a nanoform is listed separately from its non-nano version. Titanium dioxide as a conventional pigment, titanium dioxide as a conventional UV-filter and titanium dioxide (nano) as a UV-filter are three distinct regulatory situations. The same applies to carbon black, where the Annex IV colorant guide covers the non-nano entry alongside the 126a nanoform.

7. The 2024 turning point: Regulation (EU) 2024/858

For years the nano regime was mostly about notification and the slow build-up of authorised entries. Regulation (EU) 2024/858 (published 15 March 2024) was the first large clean-up: it moved five nanomaterial groups into Annex II (prohibited).

The transition dates were uniform across all five entries:

• 1 February 2025 — these substances could no longer be placed on the market.
• 1 November 2025 — they could no longer be made available on the market (full withdrawal, including stock already in the distribution chain).

The driver in each case was the same: the SCCS could not conclude the nanoform was safe with the data available. The prohibition is the default outcome when a nanomaterial cannot demonstrate safety.

8. The one that was restricted, not banned: Hydroxyapatite (nano)

Regulation 2024/858 did not ban everything it touched. Hydroxyapatite (nano) was added to Annex III (restricted substances) as entry 372 — permitted, but only under strict conditions:

• Maximum 10% in toothpaste and 0.465% in mouthwash
• Rod-shaped particles only, with a defined aspect-ratio distribution
• No coating or surface modification
• Not to be used in applications that may lead to exposure of the lungs by inhalation

This is the standard pattern when the SCCS finds a nanoform safe for a specific use: it goes to Annex III with conditions, not to Annex II.

9. The recurring condition: no exposure by inhalation

Read the authorised nano entries again and one phrase repeats: "not to be used in applications that may lead to exposure of the end user's lungs by inhalation." It appears on titanium dioxide (nano), zinc oxide (nano), carbon black (nano) and hydroxyapatite (nano).

The reason is consistent across SCCS opinions: the oral and dermal routes for these nanomaterials are assessed as acceptable under their conditions, but inhalation of nanoparticles carries a different and less well-characterised risk. In practice this is what makes loose powders, aerosols and sprays the highest-scrutiny formats for nano ingredients. A nano UV-filter that is fine in a cream may be non-compliant in a spray sunscreen.

10. How to verify a nanomaterial's status

Because nanoforms are listed separately and span four Annexes, verification means checking the right entry — not the conventional substance.

CosIng database — /en/cosing-database: search by INCI name to find both the conventional entry and the nanoform, with the Annex, maximum concentration and conditions for each. This is the fastest way to confirm whether a nano ingredient is authorised, restricted or prohibited, and under what conditions.

Regulatory monitoring — the nano landscape now moves with the omnibus regulations. The guide on monitoring EU cosmetic regulation changes explains how to track new SCCS opinions and amending regulations so a 2024/858-style change does not catch a formulation by surprise.

The other Annexes that complete the picture: Annex II (prohibited), Annex III (restricted), Annex IV (colorants) and Annex VI (UV-filters).

11. Frequently asked questions

How does EU law define a nanomaterial in cosmetics? Art. 2(1)(k): an insoluble or biopersistant, intentionally manufactured material with a dimension or internal structure on the 1–100 nm scale. This sector definition is binding; the 2022 Commission Recommendation is non-binding guidance.

Do I have to notify a product that contains a nanomaterial? Yes, twice: the CPNP notification (Art. 13) and a separate six-month notification to the Commission (Art. 16), unless the nanomaterial is already an Annex IV/V/VI listed colorant, UV-filter or preservative.

What is the [nano] label requirement? Art. 19(1)(g): every nanoform ingredient must appear in the INCI list with "[nano]" after its name.

Which nanomaterials were banned in 2025? Regulation (EU) 2024/858 prohibited five groups (Styrene/Acrylates copolymer, Copper, Colloidal Silver, Gold and Platinum nanoforms) from 1 February 2025, with full withdrawal by 1 November 2025.

Which nanomaterials are authorised? Titanium Dioxide (nano), Zinc Oxide (nano), MBBT (nano) and Tris-biphenyl triazine (nano) as UV-filters; Carbon Black (nano) as a colorant; Hydroxyapatite (nano) under conditions — all with a no-inhalation restriction.