Nanomaterials in EU Cosmetics: The Article 16 Notification Requirement Most Brands Get Wrong

Titanium dioxide is one of the most widely used UV filters in European sunscreen formulations. In its conventional form, it slots neatly into an existing Annex VI authorisation. In its nano form — particles below 100 nm that are insoluble or biopersistant — it triggers a completely separate regulatory pathway under Article 16 of EU Regulation 1223/2009, with a mandatory 6-month pre-market notification window that has tripped up more than a few brands we’ve worked with.

The EU’s approach to nanomaterials in cosmetics is more coherent than it gets credit for. The framework is specific, the science is cited, and the expectations are documented. The problem is that many brands — especially those entering the EU for the first time from North America or Asia — don’t realise the nano form of an ingredient is treated as an entirely different regulatory entity from its bulk counterpart. Same INCI name. Entirely different compliance obligations.

This post breaks down exactly what the rules require, where the SCCS opinions currently stand on the most commercially significant nano ingredients, and what your Product Information File needs to demonstrate before the 6-month clock even starts.

How Regulation 1223/2009 Defines “Nanomaterial” — and Why the Precise Wording Matters

Article 2(1)(k) of Regulation 1223/2009 defines a nanomaterial as “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 of that definition deserve close attention.

First, the material must be intentionally manufactured. Incidental nano-scale particles — say, from milling a mineral pigment — don’t automatically fall under Article 16 if they weren’t designed to have nano-scale properties. In practice, this distinction can be difficult to defend without clear documentation of your manufacturing process and particle size distribution data from the supplier.

Second, the insoluble or biopersistant criterion is doing significant regulatory work. Soluble nanomaterials are generally excluded because they dissociate into ions or molecules that behave identically to their bulk counterparts. This is why nano-scale hyaluronic acid fragments, for example, are typically not subject to Article 16 notification — they dissolve. Zinc oxide nanoparticles, by contrast, are insoluble at physiological pH and are very much in scope.

Third, the 1–100 nm range applies to external dimensions or internal structure. This means hollow nanoparticles, nanotubes, and nanostructured materials with internal pores in that size range can be captured even if their overall particle dimensions are larger. For brands using nanoencapsulated actives — retinol, vitamins, botanical extracts — this is not a theoretical concern.

If you’re unsure whether your ingredient qualifies, TEM or DLS particle size characterisation data from the ingredient manufacturer is the baseline for any Article 16 assessment. “The supplier says it’s non-nano” is not a defensible position in a PIF review.

The Article 16 Notification: What It Requires and What the Commission Can Do

Under Article 16(3) of Regulation 1223/2009, the Responsible Person must notify the European Commission — via the Cosmetic Products Notification Portal (CPNP) — at least 6 months before the product is placed on the market. The notification must include:

• The INCI name and chemical identity of the nanomaterial
• Full physico-chemical characterisation: particle size distribution, shape, surface area, surface chemistry, and solubility
• An estimated annual quantity expected to be placed on the EU market
• The toxicological profile and available safety data
• Reasonably foreseeable exposure conditions for the end consumer

This is meaningfully different from the standard CPNP product notification that every cosmetic product requires under Article 13. The Article 16 submission is pre-market, substance-specific, and triggers a Commission review process. If the Commission identifies concerns, it can refer the notification to the SCCS for a formal opinion. And if the SCCS identifies a risk, the Commission can restrict or prohibit the ingredient via a delegated act — before your product ever reaches a pharmacy shelf.

One point that surprises many clients: the notification obligation applies even if the nanomaterial is already listed in the annexes. If your UV filter is titanium dioxide [nano], it appears in Annex VI — but you still need to submit the Article 16 CPNP notification for your specific formulation before launch. The annex listing establishes that the substance can be authorised in nano form; the notification ensures the Commission has current data on how you’re actually using it.

Missing this step is not a minor paperwork oversight. It’s a compliance failure that can result in market withdrawal requests from national competent authorities.

Where the SCCS Currently Stands on High-Volume Nano Ingredients

The Scientific Committee on Consumer Safety has issued opinions on several nanomaterials that matter commercially to cosmetic formulators. The two most consequential for sunscreen and colour cosmetic brands are titanium dioxide and zinc oxide.

Titanium dioxide [nano]: In opinions published in 2021, the SCCS concluded that titanium dioxide nanoparticles cannot be considered safe when applied in a manner that leads to inhalation. This effectively excludes nano TiO₂ from spray sunscreens, spray foundations, and any aerosolised product format. For non-spray formulations — creams, lotions, sticks — the SCCS maintained a positive opinion, subject to specific particle size and coating requirements. The maximum authorised concentration under Annex VI entry 27 is 25%.

The spray restriction has real commercial implications. Brands formulating a “sunscreen mist” or “setting spray with SPF” using nano TiO₂ had to either reformulate with non-nano titanium dioxide, switch to zinc oxide in nanoform, or move entirely to organic UV filters.

Zinc oxide [nano]: The SCCS reached a more permissive conclusion for nano zinc oxide in its 2021 opinions, finding it safe for use in cosmetics — including spray products — at concentrations up to 25%. The opinion carries conditions: specific particle size and coating parameters apply, and the assessment excluded applications where fine dry particles could be inhaled deeply into lung tissue. Spray aerosols with very fine droplet size remain a careful formulation question even with nano ZnO.

Carbon black [nano]: Listed in Annex IV as a permitted colorant (CI 77266), carbon black in nanoform has been subject to SCCS review and has raised concerns regarding genotoxicity in certain preparations. The regulatory status of specific nano carbon black grades is still evolving. If you’re using carbon black in lip products, eye products, or formats with any inhalation exposure pathway, the most current SCCS opinion should inform your safety assessment directly — not the annex entry in isolation.

The broader lesson: SCCS opinions are living documents. The committee can be tasked with re-evaluations as new in vitro, in silico, or post-market data emerges. Monitoring the SCCS work programme is part of any serious EU cosmetics regulatory practice, not just a box-ticking exercise at initial authorisation.

The [nano] Labelling Requirement: Where Brands Consistently Fall Short

Article 19(1)(g) of Regulation 1223/2009 is unambiguous: the ingredient list must include all nanomaterials, with the ingredient name followed by the word “nano” in brackets — [nano]. So titanium dioxide in nanoform appears as Titanium Dioxide [nano], not simply Titanium Dioxide.

Simple in theory. In practice, national market surveillance authorities — including the French DGCCRF, which runs regular targeted inspections across cosmetics categories — routinely identify labelling non-compliance in this area. The most common failure patterns we see:

Using the non-nano INCI name without the [nano] designator. The INCI name for the nano and non-nano forms of an ingredient is identical. Only the [nano] suffix distinguishes them. If your formulation uses the nano form, “Titanium Dioxide” on the label is a non-compliance — even if that exact INCI name appears in the annexes.

Inconsistency between the product label and the CPNP notification. If your Article 16 notification documents a nano ingredient, your on-pack label and your CPNP product notification must both reflect it. Discrepancies between the two are a direct flag during competent authority review.

Third-party manufacturing without adequate supply chain transparency. Brands sourcing finished products from contract manufacturers outside the EU sometimes receive goods with unlabelled nano ingredients. The Responsible Person carries this compliance liability — not the contract manufacturer. Your quality agreement must require written disclosure of all nanomaterials, backed by particle size data.

Relying on supplier marketing claims without independent verification. If a supplier markets a pigment or filter as “non-nano,” that claim must be supported by documented particle size characterisation in your PIF. “The supplier told us it’s non-nano” will not satisfy a competent authority inspection.

What Your Product Information File Needs to Demonstrate

If your formulation contains a nanomaterial — whether notified under Article 16 or included under an existing annex entry — the PIF must contain:

• Physico-chemical characterisation data for the nano ingredient: particle size distribution (D50 and D90 at minimum), BET surface area, surface chemistry description, morphology confirmed by TEM imaging, and solubility profile
• Article 16 notification confirmation: the CPNP submission reference, submission date, and the 6-month pre-market timeline documented explicitly
• A cosmetic product safety report (Part A and Part B under Annex I) that specifically addresses nanomaterial-related exposure — including dermal penetration data or a scientifically justified rationale for why significant dermal penetration is unlikely
• Direct references to applicable SCCS opinions, with an explicit assessment of whether your specific use conditions — product type, concentration, particle size, coating — fall within the scope of those opinions

The dermal penetration point matters more than many safety assessors appreciate. The SCCS’s positive opinions for titanium dioxide and zinc oxide in nanoform are partly premised on evidence that intact particles do not penetrate significantly through healthy intact skin. If your product is intended for use on compromised skin, mucous membranes, or areas where the skin barrier is disrupted — as some therapeutic cosmetics are — that foundational assumption may not hold, and your safety report must address it directly rather than defaulting to the SCCS opinion summary.

Before Your Next EU Launch: The Sequence That Avoids the 6-Month Scramble

The brands that handle nanomaterial compliance without incident are the ones that identify nano ingredients at the formulation brief stage — not during label artwork review or, worse, a pre-launch audit. The sequence that works:

1. Confirm nano status with physico-chemical characterisation data from the ingredient supplier, reviewed by your safety team
2. Verify the ingredient appears in the applicable annex (or that prior SCCS opinions cover your use conditions)
3. Submit the Article 16 CPNP notification at least 6 months before your target launch date — and document that submission date formally
4. Commission a safety assessment that explicitly covers nano-specific exposure, penetration, and the applicable SCCS opinion scope
5. Confirm [nano] labelling is correctly applied in all language versions across all markets — French, German, Spanish, and others as relevant
6. Retain all documentation in the PIF for the standard 10-year post-last-sale retention period under Article 11

Six months feels like a long runway. In a complex formulation project with multiple active ingredients, a retailer timeline, and parallel safety assessment work, it disappears faster than it looks on a Gantt chart. The brands that encounter no surprises are the ones that treat Article 16 as a launch-defining milestone, not a late-stage compliance checkbox.

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Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team

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Related from our network

• Physico-Chemical Characterisation and Stability Testing for Cosmetic Ingredients — Qalitex Laboratories provides ISO 17025–accredited testing to support EU cosmetics PIF documentation, including particle size analysis for nanomaterial compliance.
• Cosmetic and NHP Ingredient Testing for North American Market Entry — Androxa supports brands navigating Health Canada’s cosmetics and natural health product frameworks before or alongside an EU launch.