EU REACH Nanomaterial Registration & Notification: Key Insights

Regulatory Overview

Nanomaterials are widely applied across various industries due to their unique physicochemical properties. However, their increasing usage has raised concerns over potential health and environmental risks, prompting intensified regulatory scrutiny worldwide. The European Union (EU) and its Member States have introduced comprehensive regulatory frameworks for nanomaterial registration & notification, placing higher compliance demands on companies operating within or exporting to the EU market.

Definition of Nanomaterials

The EU generally adopts the definition proposed by the European Commission in 2011, which identifies a substance as a nanomaterial if 50% or more of the particles in the number size distribution have at least one external dimension between 1 nm and 100 nm.

In June 2022, the EU revised this definition to include certain exceptions where materials do not strictly meet the dimensional criteria, such as:

• Nanofibers: Diameter < 1 nm, Length > 100 nm
• Nanosheets: Thickness < 1 nm, other dimensions > 100 nm

EU REACH Nanomaterial Registration

Under the amended REACH Regulation (COMMISSION REGULATION (EU) 2018/1881), effective January 1, 2020, companies manufacturing or importing nanomaterials in quantities of 1 tonne or more per year must submit a dedicated nanoform registration dossier to the European Chemicals Agency (ECHA).

This includes:

• Characterization of each nanoform
• Use-specific safety assessments
• Human health and environmental risk evaluations

National Nanomaterial Notification Requirements in EU Member States

In addition to REACH, several EU countries have introduced independent nanomaterial reporting schemes. Companies producing, selling, or distributing nanomaterials in these countries must fulfill both REACH registration and national notification obligations.

Current EU countries with mandatory nano notification systems include:

France – R-nano Reporting System

• First national nanomaterial notification scheme in the EU, launched in 2013
• Mandatory for producers, importers, and distributors of nanomaterials exceeding 100g/year
• Annual notification deadline: May 1 of the following year

Belgium – National Nano Registry

• Established under the Royal Decree of May 27, 2014
• Applies to companies placing more than 100g/year of nanomaterials or mixtures on the market
• Annual update required between January 1 – March 31
• Managed by the Federal Public Service for Health, Food Chain Safety and Environment (FPS)

Denmark – Nano Product Registry

• Introduced under Ministerial Order No. 644 (2014), administered by the Danish EPA
• Applies to mixtures and articles containing or releasing nanomaterials
• Requires product-level declarations including REACH registration number
• Annual deadline: August 30

Sweden – KIFS Regulation 2017:7

• In effect since 2018
• Requires notification of nanomaterial content in chemical products and biocides exceeding 100 kg/year
• Exemptions: natural nanomaterials, pigments, metal powders
• SMEs with annual turnover < SEK 5 million are exempt

Norway – Chemicals Notification System

• Integrated with the national chemical registry managed by the Norwegian Environment Agency
• Since March 2015, “nano” reporting is mandatory for products containing > 100 kg/year
• Requires submission of material characteristics, usage, and registration details

Our Services

Due to the complexity and variation in national regulations, nanomaterial compliance requires extensive expertise. We offer comprehensive solutions to help companies achieve efficient and accurate compliance across all relevant jurisdictions.

Only Representative (OR) Services for Non-EU Companies

Act as your legal entity in the EU to fulfill REACH nano registration obligations.

EU REACH Nanomaterial Registration Support

Full lifecycle support, including data gap analysis, dossier preparation, and ECHA communication.

National Nano Notification Services

Tailored services for France (R-nano), Belgium, Denmark, Sweden, and Norway.

Nanomaterial Identification & Testing Services

Work with accredited labs to characterize nanomaterials and ensure reliable, regulation-ready data.

Consulting & Technical Support

Provide expert guidance on regulatory strategy, risk assessment, and compliance optimization.

Why Choose Us?

Experienced Expert Team

Over 15 years of practical experience in regulatory response and risk assessment. Our experts possess in-depth knowledge of global regulatory trends and offer precise, efficient technical solutions.

Extensive Laboratory Network

Strategic partnerships with leading domestic and international labs ensure accurate and credible test data to support your compliance efforts.

Efficient Regulatory Communication

Long-standing relationships with authorities and industry stakeholders enable rapid updates on regulation changes and streamlined communication on your behalf.

Global Service Network

Our UK subsidiary, REACH24H CONSULTING (UK) LTD, extends our global reach and supports efficient fulfillment of REACH and other international regulations, reducing your compliance burden and cost.

Need help navigating nanomaterial regulations in the EU?

Contact REACH24H to ensure smooth compliance and protect your market access.