Within the EU regulatory framework there are quite a number of different definitions for the term “nanomaterial”. Each of them strongly depends on the field of material application and the respective regulatory legislation.

The Verband der Mineralfarbenindustrie e.V. (VdMi) recently published a document comparing a compilation of relevant nanomaterial definitions in the EU. As part of the document they also highlight respective regulatory consequences from their point of view.

We want to share this – as we think – very helpful compilation of nanomaterial definitions and insights with you. In addition, we provide some further NM associated definition information (where provided; e.g. describing “agglomerates”, “aggregates”, etc.) referring to the following EU regulatory frameworks and the respective reference:

EU Commission
REACH Annex
– Regulation on cosmetic products
– Regulation on biocidal products
– Regulation on medical devices
– Regulation on provision of foodinformation
– Novel Food Regulation

Definition Nanomaterial

The actual recommendation on the definition of a nanomaterial provided by the EU commission (2011/696/EU), (published 2011) reads as follows:

A natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm – 100 nm. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %. By derogation from the above, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.


The definition of nanoform according to the annex of the REACH regulation (1907/2006), published 2018 (EU 2018/1881) and in force since January 2020 [see, respective annex chapter 3(a)] is documented as follows:

“On the basis of the Commission Recommendation of 18 October 2011 on the definition of nanomaterial (1), a nanoform is a form of a natural or manufactured substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm, including also by derogation fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm.”


The REACH annex further specifies the terms “particle”, “agglomerate” and “aggregate”:

“For this purpose, “particle” means a minute piece of matter with defined physical boundaries; “agglomerate” means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components and “aggregate” means a particle comprising of strongly bound or fused particles.”


According to article 2 “Definitions”, paragraph 1 (k) of the regulation on cosmetic products (EC1223/2009, published 2009), nanomaterials are defined as described in the following:

‘Nanomaterial’ means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm”


The regulation on biocidal products (EU528/2012 , published December 2012) defines nanomaterials, particles, agglomerates and aggregates in Article 3, paragraph 1(z) as following:

‘Nanomaterial’ means a natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm. Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials.

‘Particle’, ‘agglomerate’ and ‘aggregate’ are defined as follows:

  • ‘Particle’ means a minute piece of matter with defined physical boundaries,
  • ‘Agglomerate’ means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components,
  • ‘Aggregate’ means a particle comprising strongly bound or fused particles;


  • The term nanomaterial as well as the terms particle, agglomerate and aggregation are also defined under the regulation of medical devices [EU 2017/745 : Article 2 “Definitions”:(18)-(21)], published in May 2017:

    ’Nanomaterial’ means a natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm; Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall also be deemed to be nanomaterials; ‘Particle’, for the purposes of the definition of nanomaterial in point (18), means a minute piece of matter with defined physical boundaries; ‘Agglomerate’, for the purposes of the definition of nanomaterial in point (18), means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components; ‘Aggregate’, for the purposes of the definition of nanomaterial in point (18), means a particle comprising of strongly bound or fused particles;


    During November 2011 another definition of nanomaterial was published within the regulation on provision of food information (EU 1169/2011 , Article 2, paragraph 2 (t)). It is identical to the definition provided within the novel food regulation (EU 2015/228 3, Article 3, paragraph 2 (f), published in December 2015) and includes also properties that are characteristic of the nanoscale and reads as follows:

    ‘Engineered nanomaterial’ means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglom¬erates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale.
    Properties that are characteristic of the nanoscale include:
    (i) those related to the large specific surface area of the materials considered; and/or (ii) specific physico-chemical properties that are different from those of the non-nanoform of the same material;”


    As noted initally: The EU regulatory framework has quite a number of different definitions for the term “nanomaterial”. This broad varitiy of definitions has different consequences for the regulation of NM in the respective EU framwork. In one of our next blog entries we’ll discuss a selection of this consequences and link to according measures we provide!

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    Latest update of this blog entry: 15th of February 2021

    This blog entry does not permanently raise claim for the completness and topicality of definitions.


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