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Definition of a nanomaterial

The EU adopted a definition of a nanomaterial in 2011 (Recommendation on the definition of a nanomaterial (2011/696/EU)). Its provisions include a requirement for review "in the light of experience and of scientific and technological developments. The review should particularly focus on whether the number size distribution threshold of 50 % should be increased or decreased". Prior to the conclusion of the review a public consultation on the considered modifications will be held. The precise date of its launch is under consideration within the end-of-term planning of the Commission.

According to the Recommendation a "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 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.

Detailed and technical information about the definition of a nanomaterial is available in the "questions and answers" section.

The definition will be used primarily to identify materials for which special provisions might apply (e.g. for risk assessment or ingredient labelling). Those special provisions are not part of the definition but of specific legislation in which the definition will be used.

Nanomaterials are not intrinsically hazardous per se but there may be a need to take into account specific considerations in their risk assessment. Therefore one purpose of the definition is to provide clear and unambiguous criteria to identify materials for which such considerations apply. It is only the results of the risk assessment that will determine whether the nanomaterial is hazardous and whether or not further action is justified.

Today there are several pieces of EU legislation, and technical guidance supporting implementation of legislation, with specific references to nanomaterials. To ensure conformity across legislative areas, where often the same materials are used in different contexts, the purpose of the Recommendation is to enable a coherent cross-cutting reference. Therefore another basic purpose is to ensure that a material which is a nanomaterial in one sector will also be treated as such when it is used in another sector.

The Review

In the review the Commission reviewed all elements of the Recommendation, from the experience implementing it to its elements and clarity of wording. Extensive review reports including the options with recommendations for change have been prepared and published by JRC:

a) Compilation of information concerning experience with the definition (EUR 26567 EN)

b) Assessment of collected information concerning the experience with the definition (EUR 26744 EN)

c) Scientific-technical considerations to clarify the definition and to facilitate its implementation (EUR 27240 EN)

The Commission has launched a targeted stakeholder consultation to update, test and validate the preliminary findings of this comprehensive review. It will be open until XX June 2021.