Resumen

PELLIN, Daniela  y  ENGELMANN, Wilson. The regulatory sandbox as a source of law in the nanotech disruption case in Brazil. Mundo nano [online]. 2022, vol.15, n.28, e00043.  Epub 22-Mar-2022. ISSN 2448-5691.  https://doi.org/10.22201/ceiich.24485691e.2022.28.69671.

This article aims to consolidate the regulatory sandbox as a source of normative production to address the legal regulation of the development and application of nanotechnology. The paradox that exists between nanotechnology and risk, both inherent to development, is presented as a problem for society as it must deal with limits. For this, a legal regulation is expected. But, what legal regulation is being considered? Certainly, that produced by social intervention as a factor for validating and managing the limits of this paradox. In this sense, following another Brazilian initiative, The regulatory sandbox is presented as a possibility of legal regulation of the development and application of nanotechnology. To achieve this objective, it uses the project of the Brazilian securities commission that, together with the Inter-American Development Bank, implemented the so called sandbox normative process in order to legally regulate technology-based financial companies at an early stage. In addition, meeting the needs of risk control and favoring the development of society. The methodology used is hypothetical-inductive which qualitative approach and with a systemic-constructivist approach. As a research technique, it uses data collection, document and literature review. The results suggest that in the case of nanotechnology development and given the impossibility for the constituent legislator to know such an object, the regulatory sandbox can enable a dynamic regulation and democratic norms where all actors participate in the construction of the regulatory process, therefore impacting decision-making about innovation.

Palabras llave : nanotechnology; regulatory sandbox; regulatory impact analysis; source of law.

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