Standards & Guides

The main guides and standards of interest for the proper characterization of nanomaterials within a regulatory framework are listed here. More information can be found directly by consulting the links given.

NANOMATERIALS IDENTIFICATION

Guidance on the implementation of the Commission Recommendation 2022/C 229/01 on the definition of nanomaterial

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OECD Test No. 125: Nanomaterial Particle Size and Size Distribution of Nanomaterials

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Methodological note DGCCRF & ANSM - Analysis of nanoparticles and characterization of nanomaterials in consumer products

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ISO 19749:2021 "Nanotechnologies - Determination of particle size and shape distribution by scanning electron microscopy".

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ISO 21363:2020 "Nanotechnologies - Determination of particle size and shape distribution by transmission electron microscopy".

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CHARACTERIZATION OF THE MAIN PHYSICO-CHEMICAL PROPERTIES OF NANOMATERIALS

General

FD ISO/TR 18196 "Nanotechnologies - Matrix of measurement methods for manufactured nano-objects".

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Review of available analytical methods for characterizing nano-objects, their aggregates and agglomerates to meet regulatory requirements

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EFSA - Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles

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SCCS - Guidance on the safety assessment of nanomaterials in cosmetics - 2nd revision

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Size distribution

ISO/TS 23151:2021 "Nanotechnologies - Particle size distribution for cellulose nanocrystals".

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ISO/TS 21346:2021 "Nanotechnologies - Characterization of individualized cellulose nanofibril samples".

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NCI-NCL SOP - PCC-19: Asymmetric Flux-Force Fractionation

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Concentration

ISO/TS 24672:2023 "Nanotechnologies - Guidelines for the measurement of nanoparticle number concentration".

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Surface characterization

OECD Test No. 124: Determination of the Volume Specific Surface Area of Manufactured Nanomaterials

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OECD Test No. 126: Determination of the Hydrophobicity Index of Nanomaterials Through an Affinity Measurement

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NCI-NCL SOP Surface Chemistry - PCC-2: Zeta Potential

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NCI-NCL SOP Surface Chemistry - PCC-17: Quantification of the surface coating of metallic nanoparticles by thermogravimetric analysis

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Stability

OECD Test No. 318: Dispersion Stability of Nanomaterials in Simulated Environmental Media

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