Good to know about nanomaterials

What actually are nanomaterials? To clarify this question, the EU Commission first published a recommendation on the definition of nanomaterials in October 2011. This definition is implemented in the Regulation on Biocidal Products ((EU) No 528/2012) and the annexes of the ⁠REACH⁠ Regulation ((EU) 2018/1881). In June 2022, an adaption of the recommendation was published. According to this, the definition includes natural, incidental and manufactured materials, including their aggregates and agglomerates. At least 50% of the number-based particle size distribution of particles, either on their own or as identifiable constituent particles within aggregates and agglomerates, must be in the range 1-100 nm in one or more external dimensions. In addition, the definition also includes materials that are smaller than 1nm in two dimensions but larger than 100 nm in the third dimension (e.g. corresponding fibres, rods, tubes) and materials that are smaller than 1 nm in one dimension but larger than 100 nm in the other two dimensions (corresponding platelets). Materials that have a volume-based specific surface area smaller than 6 square metres per cubic centimetre are not considered nanomaterials.

Under the general coordination of the German Federal Environment Ministry, the Federal Environment Agency (Umweltbundesamt, UBA) participates in the Working Party on Manufactured Nanomaterials (WPMN) of the Organisation for Economic Cooperation and Development (OECD). This group  works on various aspects related to the safety of nanomaterials. One focus is the development of test guidelines and guidance documents for an international harmonized testing of nanomaterials. In this context, UBA coordinates  the German contribution to the test guideline development in the field of ecotoxicology, environmental fate and physical-chemical characterization.

The manufacturing, import and use of chemical substances is regulated by the European Chemicals Regulation REACH ((EG) No. 1907/2006). With the Regulation (EU) 2018/1881 the annexes of the REACH regulation were adopted to the specificities of nanomaterials. To assist the registration of nanomaterials in the framework of the REACH regulation ECHA provides nanospecific annexes for their general guidance on information requirements and chemical safety assessment.

There are still significant gaps in the knowledge needed to assess the potential risks of nanomaterials for humans and the environment. The Federal Environment Agency is therefore advocating the establishment of a European register of nanomaterial-containing products. This products register should provide inter alia an overview of products which are intended to release nanomaterials or for which it cannot be ruled out that a release may occur during their life cycle. Such a register would make it easier for competent authorities to set priorities in the monitoring and enforcement of relevant legislation, and they would be able to better predict how and where human and environmental exposure to nanomaterials takes place. A products register would also ensure better traceability in case of adverse effects and establish transparency for manufacturers, distributors and consumers.

The European Commission established a European Observatory for Nanomaterials (EU-ON) located at the European Chemicals Agency (ECHA). The introduction of the EU-ON is a voluntary action of the European Commission and is not associated with an obligation for producer or importers. On the contrary it is the duty of ECHA to collect existing information from various regulations of chemical safety as well as other regulatory areas other European agencies like the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA) or by marked and sector surveys.

Due to the lack of a binding European instrument France, Denmark, Belgium and also Sweden implement a national reporting obligations for nanomaterials and products containing nanomaterials, respectively, in the past years. These national instruments focus on different objectives, orientations, and objects of regulations and are obligatory for producers and importers of nanomaterials or products containing nanomaterials.

The expectation in the use of nanomaterials in the various applications are still high. Areas of applications ranges from electrical engineering, energy technology, chemistry, and material development to Pharmacy, coating technology, construction materials, and textiles. There are many chances that can be deduced for the environment, e.g. energy and resource efficiency, remediation of contaminated sites, and water treatment. Nanomaterials can exhibit changed or totally new properties and function, which needs to be considered during the environmental risk assessment.

UBA develops fact sheets on nano-enabled applications (see list below), which inform the interest public about its opportunities and risks, notably about environmental aspects. UBA has published fact sheets on several applications, like remediation of groundwater damages, textiles, OLEDs and coatings. Further fact sheets will be published.”

The German federal authorities responsible for human and environmental safety as well as metrology - the Federal Institute for Materials Research and Testing (BAM), the Federal Institute for Risk Assessment (BfR), the Federal Institute for Occupational Safety and Health (BAuA), the German Environment Agency (UBA), and the National Metrology Institute (PTB) - are supporting the rapid innovation of nano- and advanced materials with a long-term research strategy focused on research needs from a regulatory perspective. Published in 2026, the strategy aims to guide and prioritise the German federal authorities`research, but is intends to inform policymakers, funding bodies, and the scientific community on regulatory research needs for safe advanced materials. The strategy identifies the necessary safety research that, on the one hand, enables regulatory authorities to adequately assess advanced materials and, on the other hand, also supports “Safe and Sustainable by Design” (SSbD) for innovators. 

The first joint research strategy developed by federal authorities in 2007, along with an evaluation of that strategy in 2013, initially focused on the health and environmental risks posed by nanomaterials. Its update in 2016 then broadened the perspective to include further material innovations and focussed on the safe and environmentally friendly design of advanced materials.