NANOMATERIALS

Nanomaterials (NM) and nanotechnologies related to their production represent an important research area in which the synergistic development of various scientific sectors contributed to an exponential growth of new applications in areas such as chemistry, medicine, industry (electronics, textiles, food, cosmetics) and aerospace instruments, capable of creating value added on  the aspects related to human and environmental health. 
In the case of nanomaterials, the laws of physics and chemistry are very different from those in force for bulk materials and their small size (1 nm is equal to 10-9 m) affects chemical/biological reactivity. 
From the point of view of chemicals legislation, the term "nanomaterial" includes synthetic (or engineered) nanomaterials and nanostructured materials, but does not include nanoparticles derived from a natural process or as an unpredicted result of a main process. As reported in the Recommendation of the European Commission of October 18, 2011 (2011/696/EU), the definition of the term ‘nanomaterial’ should be based on available scientific knowledge. The Recommendation specifies that "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. Nanomaterials are therefore characterized by one or more dimensions of the order of 100 nm and the increase in the ratio of surface area to volume that involves a preponderance of the characteristics of the surface atoms compared to those of the internal atoms. This peculiarity affects the increase of the surface energy of the particles and makes them more biologically reactive so the chemical-physical properties are completely different from those of materials in bulk form and may became hazardous properties. 
Nanomaterials are a highly dynamic technical-scientific context, for this reason, new challenges are continuously emerging in the legislative field with noticeable implications on the specific assessment and the adequate management of potential risks related to. Nanomaterials are chemical substances and as such fall under the scope of the Regulations No. 1907/2006 (REACH) and No. 1272/2008 (CLP) that apply to chemicals in any size, shape or physical state. At present the CLP Regulation does not contain any definitions or specific provisions for nanomaterials while as far as REACH is concerned, on December 3, 2018, the European Commission published Regulation (EU) 2018/1881 introducing nanoforms of substances and nanospecific requirements by amending Annexes I, III, VI, VII, VIII, IX, X, XI and XII. In order to assure a safe use for human health and the environment and that companies provide information requirements on nanoforms of interest, manufacturers and importers of nanoforms of substances are subjected to registration under REACH and they have to take into account the following provisions with regard to: 
- the characterization of nanoforms to be registered (Annex VI) 
- chemical safety assessment (Annex I) 
- information requirements for registration (Annexes III and VII-XI) 
- the obligations of users down the supply chain (Annex XII). 
The European Commission works in cooperation with the European Chemical Agency (ECHA) and worldwide organizations, such as UNECE-GHS and OECD, to amend existing regulations, adapting them from a nanospecific perspective, and to promote the drafting of guidelines/technical documents implemented by results of national or European research programs focused on nanomaterials.