This depends on where they are to be used. For some product groups, the handling of nanomaterials is regulated very precisely:
Dyes, preservatives and UV filters may only be used in cosmetics if they have undergone a safety assessment and are explicitly approved for the respective application. This also applies if they are available as nanomaterials. Additional requirements then apply to the safety assessments. If nanomaterials are to be used for other purposes, they do not have to be specifically approved, but must be notified to the EU Commission. This notification also includes all information on size and coating for the respective application, properties, toxicological profile and safety data. In both cases, the Commission thus knows in which particle size, purity and composition as well as with which coatings or impurities the nanomaterials are used in cosmetics. Substances which have not been authorised or registered in this way are prohibited for all types of cosmetic products.
Nano-ingredients for food must always be approved. If it is a completely new, previously unused ingredient that is considered a “technically produced nanomaterial” within the meaning of the law, this ingredient must be specially evaluated and approved. The same applies to food additives: whether nanomaterials or not – additives may only be used after prior testing and approval and only for precisely defined applications in food. This also applies to additives that have already been authorised. If such a substance is produced differently (e.g. nano-small) or used with a new function, it is considered to be a completely new substance and must undergo the approval procedure again from the outset. So far, there are no approved nano-ingredients on the European market.
So-called nanocapsules are often used in food supplements to keep vitamins and minerals dissolved or to transport them to the correct place in the body. However, these nanocapsules are not independent additives, but structures that form due to the chemical properties of their components. They have neither new properties nor their own biological effect and are therefore not considered nanomaterials by law. However, the “building blocks” from which they are formed are approved food additives.
In plastics for materials intended to come into contact with food – packaging, storage containers, pots, refrigerator interiors, etc. – nanomaterials can only be used if they have been tested for safety and approved for the application in question. But even for food contact materials that are not made of plastic, manufacturers must in any case ensure that they do not release any substances into the food and pose a risk to health. They must therefore also keep an eye on nanomaterials and their behaviour. Antibacterial coatings made of nano-silver for foils and tableware, which are occasionally advertised on the Internet, are then not permitted in the EU.
Products that are intended to be effective against microorganisms and pests must undergo an approval procedure in the EU. The approval then applies to the active substance and its specific use, and additional safety requirements may be imposed (labelling, warning, etc.). Nanomaterials need their own approval, even if the active substance has already been approved in its larger version. In addition, the biocidal products, as they are ultimately to be used, must also be tested and authorised as a whole. For this purpose, the effects of the product on humans, animals and the environment are investigated and evaluated. If a product contains nanomaterials, these effects must be determined specifically using methods that have been proven to do justice to the special properties of nanomaterials.
Other product groups
Drugs and medical devices undergo very complex and extensive safety tests. Although there are no nano-rules of their own, the existing approval procedures also cover them. There are no special approval procedures for textiles, materials, paints and all other product groups. Here too, however, manufacturers must ensure that their products are safe in the intended and foreseeable application.
In addition, all chemicals in the EU must be registered, evaluated and approved for use in Europe. So far, however, nanomaterials have been treated like macroscale variants. Thus, if evaluations are available at all, the special properties of nanomaterials are not taken into account. Only from 2020 will there be a legally binding definition for nanomaterials in the REACH chemicals regulations, as well as specifications on what information and toxicological data must be submitted for registration.