Nanotechnologijų reguliavimas Europos Sąjungoje.

Abstract

In the article, the author describes the primary regulatory premises and aspects of nanotechnology, analyses the most prominent examples of nanotechnology regulation in the European Union (EU) and the U.S. as well as considers the future path for regulation. Nanotechnology is one of the newest frontier technologies aimed at nanoscale manipulation of the mostly known materials. Unfortunately, scholars and regulators are failing to agree even on the most basic definitions of nanotechnology or protocols for its assessment. Nanotechnology poses an extraordinary set of potential opportunities, risks as well as regulatory challenges. The lack of regulation has the potential to undermine the development of nanotechnology and public/business confidence, while improper regulation may do even more damage. Robust regulatory oversight based on the precautionary principle, regulation based on the existing legal framework as well as a complex approach are all considered in the article. Specific risks raised by nanomaterials and their implications are analysed. The author recognizes that regulators currently struggle with a lack of data and knowledge on assessing and managing the risks of nanotechnology. The aspects of national and international approaches to regulating nanotechnology are considered, including considerations for small economies like Lithuania. Nanotechnology regulation in the EU and the U.S. has common features in disclosure requirements and recognizing the need for risk assessment; however, significant differences emerge when it comes to informing the consumers and the public (labelling requirements). The article is ended with a summary on prospects and suggested principles for advancing nanotechnology regulation. International regulation is identified as the preferred approach, while liberal national regulation may be a beneficial initial approach in countries like Lithuania. Non-governmental and self-regulatory initiatives may be a valuable aid to the governmental regulation, since they are more adapted to changes, as it is demonstrated by the experience in regulating other emerging technologies.