The European Commission published a recommendation on the definition of nanomaterials in October 2011. The recommendation served as the basis for defining the term in various European regulations. In doing so, the Commission has provided the opportunity to define amendments or deviations in individual legal areas. Therefore, definitions in the various legal areas may (still) differ in their detail.
According to the Recommendation of the European Commission on the Definition of Nanomaterials (2011/696 / EU) , a nanomaterial may be a natural, incidental formed by processes or specifically manufactured material. It must contain particles where for at least 50% of the particles in the number size distribution, one or more external dimensions is in the size range 1 and 100 nanometres (nm). It is irrelevant whether particles are present individually in unbound state, as an aggregate or as an agglomerate. An aggregate consists of strongly bound particles. An agglomerate is a collection of weakly bound particles. In specific cases, the number size distribution threshold of 50% may be replaced by a threshold between 1% and 50% , where warranted by concerns for the environment, health, safety or competitiveness.
In addition, fullerenes, graphene flakes and single-walled carbon nanotubes with one or more external dimensions below 1 nm are also considered as nanomaterials. Fullerenes consist of carbon atoms which, with a high degree of symmetry, e.g., arranged in pentagons or hexagons, form a hollow, closed structure that is reminiscent of a ball. Graphene is a two-dimensional structure made of carbon atoms, which are arranged in such a way that the resulting pattern is reminiscent of a honeycomb. Single-walled carbon nanotubes are tubes made of carbon atoms, which can also be thought of as rolled up graphene.
The definition in the EU Cosmetics Regulation (EC) No. 1223/2009 was drawn up before the European Commission's definition recommendation was published. It defines a nanomaterial as “ 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.” Materials with an internal nanostructure are, for example, nanocomposites.
In the EU Biocide Regulation (EU) No. 528/2012, a 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"
In the EU Regulation on Novel Foods (EU) 2015/2283, the term "engineered nanomaterial " is defined as "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, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale." Nanoscale refers to a size range between 1 to 100 nm.
The revised annexes (EU) No. 2018/1881 of the EU Regulation for the Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH , (EC)) No. 1907/2006 defines the "nanoforms " of a substance as "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."
Further regulations such as for plant protection products (EC) No. 1107/2009, food contact materials (EC) No. 1935/2004 or animal feed (EC) No. 767/2009 do not yet contain a definition of the term "nanomaterial".
The European Commission published a recommendation on the definition of nanomaterials in October 2011. The recommendation served as the basis for defining the term in various European regulations. In doing so, the Commission has provided the opportunity to define amendments or deviations in individual legal areas. Therefore, definitions in the various legal areas may (still) differ in their detail.
According to the Recommendation of the European Commission on the Definition of Nanomaterials (2011/696 / EU) , a nanomaterial may be a natural, incidental formed by processes or specifically manufactured material. It must contain particles where for at least 50% of the particles in the number size distribution, one or more external dimensions is in the size range 1 and 100 nanometres (nm). It is irrelevant whether particles are present individually in unbound state, as an aggregate or as an agglomerate. An aggregate consists of strongly bound particles. An agglomerate is a collection of weakly bound particles. In specific cases, the number size distribution threshold of 50% may be replaced by a threshold between 1% and 50% , where warranted by concerns for the environment, health, safety or competitiveness.
In addition, fullerenes, graphene flakes and single-walled carbon nanotubes with one or more external dimensions below 1 nm are also considered as nanomaterials. Fullerenes consist of carbon atoms which, with a high degree of symmetry, e.g., arranged in pentagons or hexagons, form a hollow, closed structure that is reminiscent of a ball. Graphene is a two-dimensional structure made of carbon atoms, which are arranged in such a way that the resulting pattern is reminiscent of a honeycomb. Single-walled carbon nanotubes are tubes made of carbon atoms, which can also be thought of as rolled up graphene.
The definition in the EU Cosmetics Regulation (EC) No. 1223/2009 was drawn up before the European Commission's definition recommendation was published. It defines a nanomaterial as “ 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.” Materials with an internal nanostructure are, for example, nanocomposites.
In the EU Biocide Regulation (EU) No. 528/2012, a 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"
In the EU Regulation on Novel Foods (EU) 2015/2283, the term "engineered nanomaterial " is defined as "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, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale." Nanoscale refers to a size range between 1 to 100 nm.
The revised annexes (EU) No. 2018/1881 of the EU Regulation for the Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH , (EC)) No. 1907/2006 defines the "nanoforms " of a substance as "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."
Further regulations such as for plant protection products (EC) No. 1107/2009, food contact materials (EC) No. 1935/2004 or animal feed (EC) No. 767/2009 do not yet contain a definition of the term "nanomaterial".
