Classification Strategies for Regulatory Nanodefinitions - Safety of Nanomaterials along Their Lifecycle - page 46

TABLE 3.1
Deinitions of Nanomaterials for Regulatory Purposes

Restricted to
“Intentionally
Manufactured/
Engineered” Materials?

Are “Novel
Properties” an
Element of the
Deinition?

Restricted
to Size
Range

Distribution
Threshold and
Metrics

Is “Solubility”
an Element of
the Deinition?

Aggregates and
Agglomerates
Included?

Organization

European Commission Cosmetics
Directive

1-100 nm No speciic mention Ye s Ye s Ye s No

European Commission Biocides
Directive

1-100 nm 50% by number No Ye s No No

European Commission
(recommendation for a
deinition)

1-100 nm 50% by number No Ye s No No

Australian Government
Department of Health and
Ageing

1-100 nm 10% by number No Ye s Ye s Ye s

Health Canada 1-100 nm and

larger

No speciic mention No Ye s Ye s Ye s

United States Food and Drug
Administration

1-100 nm and
larger

No speciic mention No No speciic

mention

Ye s Ye s

United States Environmental
Protection Agency

1-100 nm 10% by weight No Ye s Ye s Ye s

French Ministry of Ecology,
Sustainable Development,
Transport and Housing

1-100 nm 50% by number No Ye s Ye s No

Taiwan Council of Labor Affairs 1-100 nm and

larger

No speciic mention No No speciic

mention

Ye s Ye s