Understanding the Impact of REACH regulation on Nanomaterials

20 Jan 2023

REACH regulation uses the term Nanoform to define nanomaterial in Annex VI. The legal requirement under Annex VI of REACH is to report the number-based particle size distribution with indication of the number fraction of constituent particles in the size range within 1-100 nm.

Nanomaterials are widely used in the automotive industry, cosmetics, electronics products, medicines, textile manufacturing and sports equipment.

Smaller size and surface area make studies of the toxic effects of nanomaterials more challenging. Also, their properties can be more difficult to analyze than other chemicals.

The European Union Observatory for Nanomaterials (EUON) has recently concluded that there are approximately 2200 products on the EU, EEA, and Swiss markets containing nanomaterials, of which 90 nanomaterial substances have not been listed in any of the inventories.

As of 1 January 2020, legal requirements under REACH apply to all companies that manufacture or import nanoforms. Revised annexes to the REACH regulation describe these reporting obligations.

  • Characterization of nanoforms is covered by registration and is defined under Annex VI
  • Annex I outline chemical safety assessment
  • Annexes III and VII-XI describe registration information requirements and
  • Annex XII explains downstream user obligations

For each form that qualifies as a nanoform, the manufacturer or importer must report in the registration dossier. Also, they must make sure that a corresponding hazard dataset is submitted.

As a consequence of the REACH regulation, companies must submit a great deal of information in their registrations. Companies must provide information on their nanomaterials’ properties, manufacturing processes, and intended use. Moreover, companies must also provide information on human and environmental health risks associated with their nanomaterials. Due to their wide applications in society and our increased exposure to them, it is important to understand potentially harmful effects they might have on our health and how regulatory bodies acts.

We offer a team of REACH compliance experts who can assist you in understanding the regulations and ensuring your company stays in compliance. ComplianceXL enables you to concentrate on your business while we handle compliance requirements.