Definition of nanomaterial
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.
International activities to ensure the safety of 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.
Nanomaterials and the REACH Regulation
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.
European register of products containing nanomaterials
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.
Fact sheets on nano-enabled applications
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.”
Research strategy “Nanotechnology: Health and Environmental Risks of Nanomaterials”
In 2007 the Federal Institute for Occupational Safety and Health (BAuA), the Federal Institute for Risk Assessment (BfR) and UBA issued a first joint research strategy known as “Nanotechnology: Health and Environmental Risks of Nanomaterials”, lead-managed by BAuA. The paper defines strategic objectives in the design of research activities, identifies nanospecific research fields related to environment and health, and points to areas where research is urgently needed to protect workers, users and the environment.
In 2013 the above mentioned federal authorities together with the National Metrology Institute of Germany (PTB) and the Federal Institute for Materials Research and Testing (BAM) issued a review summarising the status and important results of 85 research projects which were launched or monitored under the joint research strategy.
The new research strategy of 2016 additionally covers others advanced materials where these pose similar risks to humans and the environment or where such risks need to be studied. The strategy pursues the basic approach to ensure the development of new materials which are safe and environmental compatible over their whole life cycle with the aim to better connect safety research with innovation research. Main emphasis is on research activities regarding the development, adaption and standardization of test methods and concepts for characterization and assessment of health and environmental risks as well as on the development of adapted legislations considering nanomaterials.
The current research strategy “Nanomaterials and other advanced materials: application safety and environmental compatibility” of 2016-2020 is currently under review.