Definition of nanomaterial
What exactly are nanomaterials? To clarify this question, the European Commission published a recommendation on the definition of nanomaterials in October 2011. According to this definition, the term covers all natural, incidental and manufactured nanomaterials including aggregates and agglomerates, with 50% or more of the particles in the number size distribution being in the range from 1nm to 100 nm. Notwithstanding, a number of explicitly listed materials (fullerenes, graphene flakes and single wall carbon nanotubes – SWCNTs) with dimensions below 1 nanometer also count as nanomaterials. In addition, materials with a specific surface area by volume greater than 60 square meters per cubic centimeter may also be considered as nanomaterials. This does not mean, however, that a material which is a nanomaterial on account of its number size distribution necessarily need to have a specific surface area greater than 60 m2 cm3.
This definition makes it possible to use a threshold of between 1 and 50 percent for the number size distribution in statutory regulations where warranted by concerns for the environment, health, safety or competitiveness.
The recommendation additionally provides that by December 2014 this definition will be reviewed – particularly with regard to the number size distribution threshold – and modified if necessary in the light of experience and of scientific and technological developments.
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), which is working on various aspects relating to the safety of nanomaterials (implementation and assessment of data of a test programme, international cooperation on risk assessment strategies, sustainable development etc.) in an internationally harmonized effort. In this context, UBA coordinated Germany’s participation in a testing programme to compile substance dossiers on a selection of representative nanomaterials, including information on physico-chemical properties, environmental behaviour and toxicological and ecotoxicological risks and is now involved in the assessment of this data and the development of environment related nanospecific guidelines and guidances for a standardized testing of nanomaterials.
The released dossiers are available at the OECD website
As „Co Lead Sponsor“ of the dossier of nanoscale titanium dioxide in the framework of the OECD Sponsorship Programme, UBA summarized the results on ecotoxicology and environmental behavior originating from the dossier of nanoscale titanium dioxide.
Nanomaterials and the REACH Regulation
In addition, UBA participates in efforts at national and international level to incorporate provisions governing nanomaterials into existing legislation such as the European REACH Regulation. In this context, UBA, the Federal Institute for Occupational Safety and Health (BAuA) and the Federal Institute for Risk Assessment (BfR) have jointly developed a common concept, which was published in January 2013.
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 electronic products register should be kept centrally at EU level. A national products register would not be preferable since it would result in divergent obligations and regulations in the various EU Member States, which in turn would increase the burden on authorities and registrants.
Such a products register is neither a substitute for the further development of the REACH Regulation with regard to nanomaterials, nor for other necessary nano-specific amendments to chemicals, products and environmental legislations that are currently under discussion.
Principle for responsible use of nanomaterials
Responsible use of nanomaterials is indispensible for protection of humans and the environment. Five principles set the framework for this:
- Definition and disclosure of responsibility and management (good governance)
- Transparency regarding nanotechnology-related information, data and processes
- Commitment to dialogue with stakeholders
- Establishment of risk management structures
- Responsibility within the value chain.
The five principles apply in particular until gaps in the knowledge about risks to humans and the environment have been closed. They are also important during the period in which a scientific basis for the advancement of existing legislation is being developed.
The five principles have been established as part of a “nanodialogue” initiated by the German Federal Government. UBA and its research partners are committed to complying with these principles defined by the NanoCommission, in addition to the statutory requirements. UBA publishes the results of all of its research projects on its website. UBA experts participate in the nanodialogue ongoing at national level.
Background paper “Nanotechnology for humans and the environment – Promote opportunities and reduce risks” and fact sheets on nano-enabled applications.
The number of nanotechnical products launched on the market is growing rapidly. They can have a positive impact on the environment and the economy. However, their rising use also leads to an ever growing number of synthetic nanomaterials in the environment. There is as yet too little knowledge about the impact of nanomaterials on the environment and their potential health risks. UBA has prepared a background paper which summarises relevant aspects of nanotech’s potential to relieve the environment. The paper also identifies risks to humans and the environment and formulates recommendations for action.
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.