Nano-specific obligations
Zinc oxide appears in Annex VI of the Regulation, which lists permitted UV filters, together with specific conditions for its use in nano form — including purity criteria and permitted concentration. A nano-scale material that does not meet those conditions is not a permitted UV filter, regardless of how well it performs.
Where a product contains nanomaterial, Article 16 requires notification to the Commission before the product is placed on the market, and the ingredient declaration must show "(nano)" in brackets after the ingredient name. Product notification must be accompanied by the information specified in the Regulation, including particle characterisation data.
CPNP and the Responsible Person
Every cosmetic product placed on the EU market must have a Responsible Person established within the Union. The product information file must be kept available for inspection, and the product must be notified through the Cosmetic Products Notification Portal before it goes on sale.
The Responsible Person is normally the brand owner or an appointed entity. We are not the Responsible Person for your product — that role carries legal liability and belongs with the market-facing party. What we provide is the technical content that goes into your file: composition, particle specification, safety data, and manufacturing information.
What this means in practice
For an EU-bound project, the particle specification is part of the regulatory submission, not just a quality parameter. Whatever the material supplier's documentation says about particle size distribution, agglomeration state and coating has to stand up in the product information file.
This is a case where having a documented upstream process is a practical advantage: the technical data exists because the process was controlled from the start, rather than being reconstructed afterwards.
Regulatory structure described for orientation only. Confirm requirements with a qualified EU Responsible Person or regulatory consultant for your specific product.