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Draft Regulation: definition of \u2018engineered nanomaterials<\/strong><\/p>\n Disclaimer:<\/strong> This draft has not been adopted or endorsed by the European Commission. Any views expressed are the preliminary views of the Commission services and may not in any circumstances be regarded as stating an official position of the Commission<\/em><\/p>\n Article 1<\/strong>
\nPoint (f) of Article 3(2) of Regulation (EU) 2015\/2283 is replaced by the following:
\n\u2018(f)
\n(1) ‘Engineered nanomaterial’ means a manufactured material consisting of solid
\nparticles that are present, either on their own or as identifiable constituent particles in
\naggregates or agglomerates, and where 50 % or more of these particles in the
\nnumber-based size distribution fulfil at least one of the following conditions:
\n(a) one or more external dimensions of the particle are in the size range 1 nm to
\n100 nm;
\n(b) the particle has an elongated shape, such as a rod, fibre or tube, where two
\nexternal dimensions are smaller than 1 nm and the other dimension is larger
\nthan 100 nm;
\n(c) the particle has a plate-like shape, where one external dimension is smaller
\nthan 1 nm and the other dimensions are larger than 100 nm;
\nIn the determination of the particle number-based size distribution, particles with at
\nleast two orthogonal external dimensions larger than 100 \u03bcm shall not be considered.
\n(2) For the purposes of point (1), the following apply:
\n(a) \u2018manufactured material\u2019 means a material produced, synthesised or generated
\nfrom physical\/mechanical, and\/or biological and\/or chemical processing,
\nand\/or formulation, and\/or transformation, of raw and\/or starting materials;
\n(b) \u2018particle\u2019 means a minute piece of matter with defined physical boundaries.
\nSingle molecules are not considered \u2018particles\u2019;
\n(c) \u2018aggregate\u2019 means a particle comprising of strongly bound or fused particles;
\n(d) \u2018agglomerate\u2019 means a collection of weakly bound particles or aggregates
\nwhere the resulting external surface area is similar to the sum of the surface
\nareas of the individual components.
\n(3) A material with a specific surface area by volume of < 6 m2\/cm3 and\/or with high solubility and\/or dissolution\/degradation rate values in water as determined using the thresholds, methodologies, and media identified by the Authority shall not be considered an engineered nanomaterial.\u2019<\/p>\nThe Commission would like to hear your views.<\/h3>\n