Nanomaterials in cosmetics trigger three obligations that ordinary ingredients do not: a separate notification six months before launch, the word nano in brackets on the ingredient list, and a set of annex entries that have narrowed sharply in recent years. Miss any of the three and you have a product that is notified, on sale and still non-compliant.
The catch is that most brands do not know they are using a nanomaterial. Nano titanium dioxide and zinc oxide in a mineral sunscreen are obvious. Nano forms hiding inside a pigment dispersion, a pearlescent effect, an antimicrobial additive or a delivery system are not, because the supplier documentation often does not mention particle size at all. This guide covers how the EU defines the term, what the extra notification involves, how the label changes, and which nano ingredients have been banned or restricted.
Key takeaways
- A cosmetic nanomaterial is defined in Article 2(1)(k) as an insoluble or biopersistent, intentionally manufactured material with one or more external dimensions in the order of 1 to 100 nm.
- Nano ingredients need an Article 16 notification through the CPNP six months before placing on the market, on top of the normal Article 13 product notification.
- The ingredient list must show the INCI name followed by [nano], in brackets, for every nano ingredient.
- Regulation (EU) 2024/858 banned or restricted a group of nanomaterials, including several copper, gold, platinum, silver and styrene acrylate nano forms.
- Hydroxyapatite (nano) is now permitted only in oral products within set limits and shapes, which changed several toothpaste formulas.
- Approved nano UV filters exist in Annex VI, but they carry a restriction against sprayable applications that could lead to lung exposure.
- Solubility decides everything. A soluble material is not a nanomaterial for this purpose, even if the particles are small at some stage of manufacture.
What counts as a nanomaterial
The cosmetic definition is narrower than the general EU definition of nanomaterial, and the differences matter.
- Intentionally manufactured. Naturally occurring or incidentally generated small particles are outside the definition.
- Insoluble or biopersistent. A material that dissolves in the formula or in contact with skin is not treated as a nanomaterial, which is why nano sized droplets in an emulsion are not caught.
- One or more external dimensions in the order of 1 to 100 nm. Plate shaped and rod shaped materials count if any one dimension falls in that range, which catches more pigments than people expect.
Because the test is physical rather than chemical, the same INCI name can be a nanomaterial in one grade and not in another. Titanium dioxide is the clearest example: the pigment grade used for opacity is not nano, while the grade used for transparent UV protection is. The INCI name is identical, so only the supplier specification tells you which one you have.
Ask every raw material supplier for a written statement on particle size and solubility, and keep it in the product information file. If a supplier will not confirm nano status, treat that as an unresolved question rather than as a no. Inspections in this area usually start with a request for exactly that document.
The extra notification under Article 16
Nano ingredients require their own notification, separate from and earlier than the standard product notification.
| Obligation | Legal basis | Timing |
|---|---|---|
| Standard cosmetic product notification | Article 13 | Before placing on the market |
| Nanomaterial notification | Article 16 | Six months before placing on the market |
| [nano] in the ingredient list | Article 19(1)(g) | On the pack at launch |
| Annex conditions for the specific nano form | Annexes III to VI | Continuous |
The Article 16 notification asks for the identification of the nanomaterial, including its chemical name and INCI name, the specification including particle size and physical and chemical properties, the estimated quantity placed on the market per year, the toxicological profile, safety data relating to the category of product, and reasonably foreseeable exposure conditions.
The six month lead time is the part that damages launch plans. It is not a queue, it is a statutory period that gives the Commission time to ask the SCCS for an opinion if it has concerns. If you discover a nano ingredient four weeks before launch, the options are to delay or to reformulate. Colorants, preservatives and UV filters already permitted under the relevant annex, and used in accordance with their conditions, are exempt from this particular notification, but they still need the label declaration.
The exemption for annex listed nano colorants, preservatives and UV filters is easy to over apply. It only holds where you use the substance exactly within the annex conditions, including any restriction against applications that could lead to inhalation. Step outside the conditions and the exemption falls away along with the legality of the use.
What changed with Regulation (EU) 2024/858
The 2024 amendment was the largest nano intervention so far. It prohibited a group of nano forms outright and restricted others, on the basis that the available data did not support their safety in cosmetic use. Affected materials included several copper, gold, platinum and silver nano forms, colloidal variants of the same metals, and styrene acrylates copolymer nano forms used in rinse-off products.
Hydroxyapatite (nano) was handled differently. Rather than being banned, it was restricted to oral care use within defined limits, with conditions on particle shape and a prohibition on applications that could lead to inhalation exposure. Toothpaste brands built around nano hydroxyapatite had to check their raw material against the shape and aspect ratio conditions, not only the percentage.
The pattern is the same one described in our guide to how banned ingredients reach Annex II: an expert opinion identifies missing data, the Commission acts, and formulas that were legal for a decade stop being legal on a fixed date.
Getting the label right
The declaration itself is simple. Where an ingredient is present in nano form, the INCI name is followed by [nano] in square brackets in the ingredient list, in the normal descending order of weight. Where a substance is present partly in nano form and partly not, the practical convention is to declare it once with the nano marker, because the consumer information obligation attaches to the presence of the nano form.
Three mistakes recur:
- The marker is dropped on translated artwork. The ingredient list is not translated, so [nano] should be identical on every market version. Local artwork teams sometimes remove it.
- The marker is added where it is not needed, usually as a precaution. This is not harmless. It states that a nano form is present, which invites the Article 16 question and contradicts the file if the material is not nano.
- Sunscreen packs claim mineral protection without the marker. If the UV filter grade is nano, the marker belongs there. Our guide to INCI list preparation covers how the full list should be built.
Because the marker sits inside the ingredient list, it is one of the fastest things for a market surveillance officer to check against the formula in your product information file.
How assessors treat nano ingredients
A safety assessment for a nano containing product goes beyond the usual profile. The assessor will look for particle size distribution, morphology, surface coating and its stability, solubility and biopersistence data, agglomeration behaviour in the formula, and exposure by route, with particular attention to whether the product can be inhaled or applied to damaged skin.
Sprayable products are the recurring problem. Several annex entries for nano UV filters explicitly exclude applications that could lead to lung exposure, which rules out the pump spray or aerosol format that consumers like. If a spray format is essential to the product concept, the choice of UV filter has to change before the packaging is tooled, not after.
Bringing it all together
Nano compliance is mostly a supply chain problem wearing a regulatory hat. The rules themselves are short: notify six months ahead, mark the ingredient list, respect the annex conditions. What makes them difficult is that nobody tells you a raw material is nano unless you ask, and the answer often takes weeks to get from a distributor who has to ask the manufacturer.
Ask early, in writing, for every pigment, filter, antimicrobial and effect additive in the formula. Build the six month notification period into the launch plan for anything that comes back positive. And re-check your existing catalogue against the 2024 restrictions, because the products most likely to be affected are the ones that launched before anyone was asking these questions.
Lexora reviews formulas for nano status, prepares Article 16 notifications and checks ingredient lists against the finished formula. Start with INCI list preparation and review, add CPNP notification, or have the pack checked with a cosmetic label review.
Frequently asked questions
What must be labelled with [nano] in the EU?
Any ingredient present in the product in nanomaterial form as defined in Article 2(1)(k), meaning an insoluble or biopersistent, intentionally manufactured material with one or more external dimensions in the order of 1 to 100 nm. The INCI name is followed by [nano] in square brackets in the ingredient list.
Do I need to notify nanomaterials separately from the CPNP product notification?
Yes. Article 16 requires a separate nanomaterial notification through the CPNP six months before the product is placed on the market, in addition to the ordinary Article 13 product notification. Nano colorants, preservatives and UV filters already permitted in the annexes and used within their conditions are exempt from the Article 16 notification.
Is nano titanium dioxide still allowed in sunscreen?
Yes, within the conditions of its Annex VI entry, which includes purity and coating specifications and a restriction on applications that could lead to exposure of the lungs by inhalation. That restriction is what rules out many spray formats, so the delivery system has to be decided alongside the filter choice.
How do I know whether my raw material is nano?
Ask the supplier for a written statement covering particle size distribution, solubility and whether the grade supplied meets the cosmetic definition of a nanomaterial. Trade names and INCI names do not tell you, because the same INCI name covers nano and non-nano grades of the same substance.
What did Regulation (EU) 2024/858 change?
It prohibited a group of nanomaterials in cosmetic products, including several copper, gold, platinum and silver nano forms and certain styrene acrylates copolymer nano forms, and restricted hydroxyapatite (nano) to oral care use within set limits and particle shape conditions. Affected products had to be reformulated by the dates in the regulation.
Does a nano ingredient change my safety assessment?
Yes. The assessor needs particle characterisation, coating and stability information, agglomeration behaviour and route specific exposure, with particular attention to inhalation and application to damaged skin. A nano version of an ingredient cannot be assessed by referring to data on the conventional grade.
