Nanoforms under REACH

Nanoforms require specific registration and assessment under REACH. Failure to properly characterize and document nanoforms can result in non-compliance and market access restrictions.

Definition and Characteristics

Parameter	Requirement	Significance
Particle Size	1-100 nanometers	Primary defining characteristic
Size Distribution	50% or more in nano range	Number-based distribution
Agglomeration State	Must be characterized	Affects exposure potential
Surface Treatment	Must be specified	Influences properties and behavior

Registration Requirements

Characterization Parameters

Particle size distribution
Shape and aspect ratio
Surface functionalization
Specific surface area

Documentation

Detailed characterization data
Manufacturing process
Use and exposure patterns
Risk management measures

Critical Safety Assessment Requirements:

Aspect	Requirements	Considerations
Toxicological Assessment	Specific testing strategies Nano-specific endpoints	Special attention to particle effects
Environmental Fate	Behavior in environmental media Transformation studies	Focus on aggregation/agglomeration
Exposure Assessment	Workplace measurements Environmental release patterns	Specific metrics for nanoforms

Risk Management

Workplace Controls

Enclosed systems
Local exhaust ventilation
Personal protective equipment
Monitoring programs

Environmental Controls

Filtration systems
Waste treatment
Release prevention
Monitoring strategies

Information Requirements

Basic Characterization

Size distribution data
Shape analysis
Surface chemistry
Crystallinity

Advanced Characterization

Dissolution rate
Dispersibility
Dustiness
Surface charge

Important Considerations:

Different requirements based on tonnage bands
Specific testing strategies for nanoforms
Regular updates as science evolves
Group submission possibilities
Specific exposure scenarios needed

Critical Compliance Points:

Nanoform-specific data cannot be waived without proper justification
Each nanoform variant must be individually characterized
Testing strategies must be adapted for nano-specific properties
Regular monitoring of scientific and regulatory developments is mandatory