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Home > Nanotechnology Columns > Bergeson & Campbell, P.C. > EUON Study Finds EU Regulatory Framework Ready for Next Generation Nanomaterials

Lynn L. Bergeson
Managing Director
Bergeson & Campbell, P.C.

Abstract:
On September 19, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) announced the results of a study it commissioned to examine "next generation" nanomaterials and determine whether the current terminology used in the EU chemicals regulations, as well as the implementation of the current legal requirements for identifying nanomaterials, are likely to pose technical challenges.

September 24th, 2019

EUON Study Finds EU Regulatory Framework Ready for Next Generation Nanomaterials

On September 19, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) announced the results of a study it commissioned to examine "next generation" nanomaterials and determine whether the current terminology used in the EU chemicals regulations, as well as the implementation of the current legal requirements for identifying nanomaterials, are likely to pose technical challenges. See https://euon.echa.europa.eu/da/view-article/-/journal_content/title/study-finds-eu-regulatory-framework-ready-for-the-next-generation-of-nanomaterials The objectives of the study were to:

- Collect existing definitions of generations of nanomaterials;

- Refine these definitions to allow the sorting of different nanomaterials into different generations unambiguously;

- Establish an inventory of second or higher generation nanomaterials on the market or close to the market; and

- Assess the suitability of the terms "substance," "mixture," and "article" and of the identification and characterization parameters included in the revised Annex VI of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to describe the next generation nanomaterials found.

According to EUON, the study findings "indicate that although the regulatory framework is well-equipped to handle these materials in the near future, further guidance would benefit companies registering nanomaterials" under REACH. The study recommends further clarifications for some parameters characterizing both nanomaterials and their uses and that the guidelines on how to determine whether an object is an article under REACH could be complemented with specific examples of different nanomaterials, from simple nanoparticles to more complex assembly structures. EUON states that the European Chemicals Agency (ECHA) is updating its guidance on the identification of nanomaterials following the amendments to the REACH Annexes. The updated guidance is expected to be published later in 2019.

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