Due to the unique properties of advanced (nano)materials, risk assessment methods sometimes need to be adapted. This also extends to the laws and regulations that set requirements for such assessments. RIVM assists the European Commission and Dutch ministries in identifying and implementing these adjustments.
Regulations for advanced (nano)materials
Advanced (nano)materials must comply with the same laws and regulations as conventional substances. However, because nanomaterials have unique properties, additional requirements may be set to demonstrate their safety. To address this, several laws and regulations concerning the following topics have been revised for nanomaterials:
By law, all products that manufacturers and importers introduce to the European market must be safe, including advanced materials. The European Commission pays attention to the regulations required to achieve safe and sustainable advanced materials in the research and innovation that they support.
Risk assessment of advanced (nano)materials
The risk assessment of advanced (nano)materials is similar to that of conventional substances. However, the physical properties of these materials play a more crucial role in assessing their risks. For example, a larger surface area of a particle can increase its chemical reactivity, potentially posing a greater risk to humans and animals. Therefore, it is essential to determine these physical properties and incorporate them into the risk assessment process.
Where necessary, adequate methods must be developed for this purpose. In recent decades, significant progress has been made in establishing effective methods for nanomaterials. In many cases, these methods will also be suitable for advanced materials. However, more experience is required in applying these methods to advanced materials to confirm their effectiveness.
Overseeing the safety assessment of advanced (nano)materials
Several organisations within the European Union oversee the safety assessment of advanced (nano)materials. For industrial chemicals, this is done by the European Chemicals Agency (ECHA). The European Medicines Agency (EMA) oversees the safety assessment for medical applications. The European Food Authority (EFSA) evaluates the safety of food as well as the active substances in plant protection products. ECHA does this for biocides. EU (European Union ) member states assess whether plant protection products and biocides containing these active substances are safe. In the Netherlands, this is handled by the Board for the Authorisation of Plant Protection Products and Biocides (Ctbg).
Adapt legislation to innovation
Legislation always lags behind new technologies and developments. It is important for legislation to keep pace with these advancements as quickly as possible. This requires strong international cooperation among developers, researchers, human and environmental risk assessors, and policy makers. Such collaboration can help regulators anticipate regulatory challenges that arise from innovations and their applications, as well as assess their potential risks in a timely manner.