Harmonisation: In Europe, nanotechnology and engineered nanomaterials fall under different directives or regulations according to the known and potential risks that are induced (e.g. REACH directive, General Product Safety Directive on consumer products, Directives on Integrated Pollution Prevention and Control (IPPC), Seveso II or III Directives) and sector of application (food, health, etc.).

New challenges of novel materials and converging technologies: Novel materialsbwith specific fate and effect properties will be developed and may require novel assessment methods and management framework. Also, it may be that the need is more particularly for new applications of nanotechnologies, which will emerge from fundamental or applied research, and will be characterized by the fact that they transform, integrate and are combined with other technologies, such as synthetic biology, neurotechnology, robotics or digital technology, in so-called converging technologies.

Various stakeholder expectations: that the field is marked by large industrial stakes (promising industrial and medical applications), as well as by strong societal and environmental hopes, expectations and fears (large potential benefits and risks to human health and the natural environment), often referred to an industrial revolution beyond chemicals. This context requires specific attention to actors and stakeholders and their involvement in the governance process, which can provide guidance to regulators and policymakers.

Careful examination of needs and gaps is required: as regulatory considerations, need to address challenges of converging technologies, in which nanotechnology is a foundational technology; and the need to integrate international considerations and diversity in regulatory regimes.