EU REACH Nanomaterial Registration and Notification

Harmonized Definition of Nanomaterials in the EU

A critical foundation for chemical compliance in the European Union is the harmonized definition of a nanomaterial. According to the European Commission Recommendation (2022/C 229/01), a nanomaterial is defined as a natural, incidental, or manufactured material consisting of solid particles that are present either on their own or as identifiable constituent particles in aggregates or agglomerates.

The primary determinant for this classification is the particle number-based size distribution. A material is considered a nanomaterial if 50% or more of its particles fulfill at least one of the following criteria:

• One or more external dimensions are between 1 nm and 100 nm.
• The particle is elongated (e.g., a tube or fiber) with two dimensions under 1 nm and one over 100 nm.
• The particle is plate-like with one dimension under 1 nm and others over 100 nm.

This definition highlights that the substance must be in a solid form, and it is used across various legal frameworks, including REACH and CLP, to ensure regulatory consistency.

Explicit REACH Registration Obligations

Since January 1, 2020, explicit legal requirements under REACH have applied to companies manufacturing or importing substances in nanoforms. These reporting obligations are designed to address the specific physical and chemical properties of nanomaterials that may differ from their bulk counterparts.

Registrants are required to provide a complete characterization for each nanoform or set of nanoforms covered by the registration. This includes detailed data on particle size distribution, shape, morphology, and surface chemistry. Furthermore, a chemical safety assessment must be conducted to demonstrate that the substance can be used safely without posing undue risks to human health or the environment.

The registration dossier must clearly link each nanoform to a specific and complete dataset, ensuring that the hazard and exposure assessments are representative of the actual material placed on the market. Proregulations assists companies in preparing these technical dossiers to meet ECHA's rigorous completeness checks.

National Nanomaterial Reporting Registries

In addition to the centralized REACH registration, several EU Member States maintain mandatory national registers that require annual declarations for nanomaterials. These registries enhance traceability and allow national authorities to monitor the use of nanoparticles within their borders.

• France: R-Nano Register

Under the French Environment Code, companies that produce, import, or distribute at least 100 g of substances in nanoparticulate form per year must submit an annual declaration. For activities conducted during the year 2025, the reporting exercise takes place between January 1 and April 30, 2026. This system is crucial for national risk assessment and provides public transparency regarding nanomaterial use.

• Belgium: National Nano Register

Belgium requires the registration of both substances and mixtures containing nanomaterials if more than 100 g per year is placed on the Belgian market. Companies must provide data on the substance identity, particle size, and professional customers. The annual update for the previous year's activities must be completed between January 1 and March 31.

• Other Regional Registries

Countries such as Sweden, Denmark, and Norway also maintain product registers that include mandatory declarations for intentionally added nanomaterials. These systems generally apply to chemical products and hazardous substances exceeding specific tonnage thresholds, such as 100 kg per year in Sweden.

Compliance Deadlines and Strategic Considerations

Enterprises must stay vigilant regarding recurring reporting windows and the evolving technical standards for nanomaterial testing.

Starting in 2026, the EU's "One Substance, One Assessment" framework aims to further streamline these evaluations, making it even more important for companies to maintain consistent data across all national and regional filings. Early preparation is essential, especially for importers who rely on data from non-EU suppliers to fulfill their local reporting obligations.

Proregulations' Nanomaterial Compliance Services

Our team provides specialized technical solutions to help you manage the complex data requirements of nanomaterial regulations across the EU.

• Nanoform characterization and identification
  We help determine if your products meet the 2022 EU nanomaterial definition and provide guidance on characterizing nanoforms.
• ECHA registration dossier preparation
  Proregulations manages the creation and update of IUCLID dossiers, ensuring that all specific toxicological and ecotoxicological data requirements for nanoforms are addressed.
• Annual national registry declarations
  Our experts handle the year-end and spring reporting cycles for the French R-Nano and Belgian registries, ensuring your company avoids penalties for late or inaccurate filings.
• Supply chain data coordination
  We assist in collecting the necessary chemical specifications from your global suppliers and protecting confidential business information through authorized representative services.

If you need to ensure your nanomaterials are fully compliant with EU REACH and national reporting requirements, please contact us.