Nanomaterials in Cosmetics
Bringing innovative formulations to market requires strict compliance. In Belgium, the presence of nanomaterials in cosmetics triggers a particularly high level of regulatory scrutiny.
Centralized European registration is essential. Moreover, a series of bans and restrictions dictate the use of certain nanomaterials. In Belgium, national monitoring is also required as soon as minimal volume thresholds are reached.
A successful market launch requires anticipating the notification timeline. Brands must simultaneously clear their ingredients and comply with annual reporting requirements.
Key Takeaways: The 4 Pillars of Nanomaterial Management
Four fundamental principles should guide your strategy:
- The volume trigger: A declaration is mandatory as soon as you exceed 100 g/year of a substance or mixture containing nanomaterials.
- Centralized notification: Every cosmetic product must be registered on the European CPNP portal, with precise details regarding the presence of nanomaterials.
- Pre-market notification: A specific CPNP notification prior to launch is required for nanomaterials other than colorants, preservatives, and UV filters.
- Exclusion of banned substances: Formulations must strictly exclude permanently banned nano-ingredients. Products containing these substances must be pulled from the market.
How is a Nanomaterial Defined?
Physical Characteristics
An ingredient is not classified as a nanomaterial based on size alone; a combination of physicochemical parameters comes into play. In cosmetics, a "nanomaterial" refers to an insoluble or biopersistent material that is intentionally manufactured.
Beyond insolubility and biological persistence, the dimensional criterion is key: one or more external dimensions, or an internal structure, must fall within the 1 to 100 nm range. This targeted definition inherently excludes soluble or degradable substances, even if they temporarily reach nanoscale dimensions during processing.
Direct Impact on the INCI List
This specificity drives a need for consumer transparency. Nanomaterials must be mandatorily labeled in the official ingredient list. This is indicated by adding the word "nano" in parentheses directly after the substance's INCI name (for example: Titanium Dioxide (nano)).
How to Notify a Product on the CPNP Portal
General Registration
Before bringing a product to market, a centralized process must be completed. Manufacturers, importers, or designated third parties are required to register cosmetic products on the CPNP portal.
During this procedure, generic declarations are not permitted. The notification must unambiguously state whether the product contains nanomaterials. The digital dossier requires their exact identification alongside a detailed description of the foreseeable exposure conditions for the end user.
The Specific Six-Month Advance Notice
An additional timeframe applies to certain ingredient categories. Cosmetics containing nanomaterials other than colorants, preservatives, and UV filters are subject to an extra procedure.
For these ingredients, a specific CPNP notification is required six months prior to market launch. This waiting period allows for the evaluation of the safety dossier. It should be noted that colorants, preservatives, and UV filters in nano form follow a separate regime: they must be authorized prior to use and are exempt from the six-month advance notice.
The CPNP Portal and the Belgian Registry: Two Distinct Procedures
Both systems must be managed simultaneously. The table below summarizes their differences in scope.
| Criteria | European Portal (CPNP) | Belgian Nanomaterial Registry |
|---|---|---|
| Trigger Threshold | None (applies from the very first product placed on the market) | Over 100 g/year of a substance/mixture |
| Frequency | Single initial notification (unless reformulated or information changes) | Annual update (January 1st to March 31st) |
| Specific Timeframe | 6 months prior (excluding UV filters, colorants, preservatives) | Before being placed on the market for the first time |
In practice, validating the CPNP dossier does not exempt you from the annual local declaration.
Why Does Belgium Have a National Registry?
The Goal of Local Traceability
Belgium maps the physical volumes circulating within its borders. Registration in the Belgian registry must take place well before the initial market launch.
Dynamic data management is required post-launch. An annual update must be completed between January 1st and March 31st. This declaration precisely outlines the quantities of nanomaterials placed on the market during the previous year, as well as the professional users directly involved in the distribution chain.
An Activation Threshold
This procedure applies to companies placing more than 100 g/year of a substance or mixture containing nanomaterials on the Belgian market.
Which Nano Ingredients Are Permanently Banned?
Recent Bans
The formulation landscape has been reshaped by a series of recent bans. Several nano ingredients are now prohibited, including the nano forms of styrene/acrylate copolymers, copper and colloidal copper, colloidal silver, gold and colloidal gold, platinum and colloidal platinum, as well as various derivatives of these precious metals.
These measures targeted historically widely-used components, forcing brands to reformulate entire lines of skincare and makeup products.
The Phase-Out Timeline
The phase-out schedule was structured around strict deadlines. As of February 1, 2025, products containing banned nanomaterials could no longer be placed on the market.
The final stage occurred on November 1, 2025, marking the definitive removal of these products from retail shelves. With these deadlines now passed, any presence of these substances is strictly prohibited.
Specific Restrictions on Hydroxyapatite
Certain substances are subject to strict concentration limits, such as in oral care. Hydroxyapatite (nano) (CAS No. 1306-06-5) is restricted to a maximum concentration of 10% in toothpaste and 0.465% in mouthwash. Products exceeding these precise limits cannot be sold, compelling laboratories to measure their dosages meticulously.
How to Build a Solid Safety Dossier
The use of a nanomaterial requires undeniable scientific evidence to thoroughly evaluate product safety.
A nanomaterial safety assessment guide is available to help toxicologists prepare these safety dossiers.
This methodology covers physicochemical characterization, exposure assessment, toxicological evaluation, and risk assessment. These elements are essential for structuring the evaluation during the mandatory six-month waiting period imposed on the CPNP portal.
Frequently Asked Questions (FAQ): Managing Your Formulations
Is an ingredient subject to the 6-month delay automatically approved after this period?
No, this timeframe is designated for evaluating the safety dossier submitted on the CPNP portal. If doubts remain regarding toxicology or exposure potential, additional data may be requested or the ingredient's use may be restricted, thereby blocking its market launch.Is it possible to use the "nano" label for a soluble ingredient?
Random or precautionary labeling is strongly advised against. A soluble or non-biopersistent ingredient that fails to meet the strict criteria must not carry the (nano) designation in the INCI list. For example, an ingredient solubilized in micelle form within an emulsion does not meet the insolubility criteria, does not qualify for nano status, and therefore cannot be labeled as such.Can subcontractors file the declaration with the Belgian registry?
The companies placing the product on the market must ensure the declaration is filed. If an importer or a Belgian subsidiary manages the distribution of the critical volumes targeted by the threshold, that specific entity bears the responsibility for the annual update, regardless of the original manufacturer.Conclusion
The requirements surrounding nanomaterials are profoundly changing the strategy of research laboratories. The time required to validate safety assessments, combined with annual volume management, is leading many formulators to rethink their product design.
To bypass the constraints associated with the "nano" label, the industry is increasingly turning to macromolecular alternatives or modified ingredients to ensure solubility. These shifts raise new questions about the ability to maintain the same level of performance—such as UV protection efficacy, active ingredient bioavailability, or sensory appeal—while drastically reducing reliance on these microscopic technologies.
