DEFINITION
Materials defined under REACH with particle sizes from 1–100 nanometres in at least one dimension, which are subject to specific registration and reporting obligations.
DeclarationNanomaterials (REACH)
Nanomaterials are chemical substances or materials where 50% or more of the particles in the number size distribution have one or more external dimensions in the range of 1–100 nanometres. The REACH Regulation treats different nanoforms of a substance as separate registrations if their properties differ significantly.
Additional requirements apply to the registration of nanomaterials: manufacturers and importers must provide specific information to characterise the nanoform, including particle size distribution, shape, surface area, and surface chemistry. ECHA provides specific guidance documents outlining the applicable testing methods and data requirements for nanoforms.
Companies must account for the specific properties of nanomaterials in their chemical safety assessments, as these may differ from the bulk form regarding toxicity, bioaccumulation, and environmental behaviour. Classification and labelling under the CLP Regulation must also be nanoform-specific if differing hazards are identified.
Key Points
- Definition: Particle size of 1–100 nm in at least one dimension for ≥50% of the particles in the number size distribution
- Separate registration requirement for different nanoforms of a substance under REACH
- Additional information requirements for characterisation (size, shape, surface area, surface chemistry)
- Specific chemical safety assessment required due to potentially differing hazard properties
- ECHA guidelines define adapted testing methods and data requirements for nanomaterials
- Nanoform-specific classification and labelling under the CLP Regulation in the event of differing hazards
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