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 updated Recommendation of the European Commission (2022/C 229/01) , a nanomaterial is present if at least 50% of the number of solid particles it contains meet at least one of the following conditions:
one or more external dimensions of the particles are in the size range from 1 nm to 100 nm;
the particles have an elongated shape, with two external dimensions being less than 1 nm and the other external dimension being greater than 100 nm;
the particles have a plate-like shape, with one external dimension being less than 1 nm and the other external dimensions being greater than 100 nm.
It is irrelevant whether this amount is intentionally or unintentionally present in the material.
In the future, this recommendation will be included in the REACH regulation (Regulation concerning the Registration, Evaluation, Authorization and Restriction of Chemicals) and the sector-specific regulations.
The definition in the EU Cosmetics Regulation (EC) No. 1223/2009 was drawn up before the European Commission's first definition recommendation (2011/696/EU) 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 updated Recommendation of the European Commission (2022/C 229/01) , a nanomaterial is present if at least 50% of the number of solid particles it contains meet at least one of the following conditions:
one or more external dimensions of the particles are in the size range from 1 nm to 100 nm;
the particles have an elongated shape, with two external dimensions being less than 1 nm and the other external dimension being greater than 100 nm;
the particles have a plate-like shape, with one external dimension being less than 1 nm and the other external dimensions being greater than 100 nm.
It is irrelevant whether this amount is intentionally or unintentionally present in the material.
In the future, this recommendation will be included in the REACH regulation (Regulation concerning the Registration, Evaluation, Authorization and Restriction of Chemicals) and the sector-specific regulations.
The definition in the EU Cosmetics Regulation (EC) No. 1223/2009 was drawn up before the European Commission's first definition recommendation (2011/696/EU) 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".
