A Preliminary Risk Analysis of Nanotechnology R&D, Based on the Commission's Workshop Held 1-2 March (link)

Brussels, 03 May 2004

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EXECUTIVE SUMMARY

The Health and Consumer Protection Directorate General of the European Commission convened a workshop in Brussels on 1.2 March 2004 entitled $#129;gMapping out Nano Risks$#129;h, inviting an international, interdisciplinary group of seventeen experts to examine the hazards, exposure, and risks to human and environmental health potentially associated with materials derived from nanotechnologies (NTs) within the next 3.5 years.

This report comprises two parts. The first part consists of outcomes.a preliminary risk analysis as well as a general statement and a concept note on a hazard trigger algorithm as a potential prioritization tool for use by regulators, which follow up on work initiated during the workshop by two working groups. The second part contains documents produced and circulated prior to 1 March 2004, namely, a collection of short contributions by the invited experts, the terms of reference, and the agenda.

The Mapping out Nano Risks workshop

• pointed out the need for and offered clarifications about nanotechnologies terminology, establishing, above all, the need to distinguish between nanotechnologies and, specifically, to distinguish between free and fixed nanoparticles (NPs), the latter being much less likely to raise concerns because of their immobilization (Subsection 1.1.1.1);

• reconfirmed the serious concerns that unintentionally produced and released (waste) nanosized particles created via conventional technology (e.g., airborne combustion by-products) continue to pose;

• highlighted that some engineered nanoparticles produced via nanotechnology may have the potential to pose serious concerns.the most significant ones relating to NTs within the next 3.5 years.and require further studies (Subsection 1.1.1.2);

• revealed that panel experts were of the unanimous opinion that the adverse effects of NPs cannot be predicted (or derived) from the known toxicity of bulk material;

• exposed the limits that preclude a complete risk assessment today, in particular, the present scarcity of dose-response and exposure data (Subsection 1.1.1.3);

• gave rise to twelve recommendations from the experts including developing a nomenclature for NPs, assigning a new Chemical Abstract Service (CAS) Registry number to engineered NPs, advancing science, developing instruments, developing risk assessment methods, promoting good practices, creating institutions to monitor nanotechnologies, establishing a dialogue with the public and with industry, developing guidelines and standards, revisiting existing regulations and, when appropriate, revising them, containing free engineered nanoparticles, eliminating whenever possible and otherwise minimizing the production and unintentional release of waste nanosized particles (Subsection 1.1.3); and

• led to the identification of policies options relating to R&D; norms, standards, guidelines, and recommendations; international cooperation; legislation; risk assessment; public understanding and shaping of nanotechnologies; international exchanges; privacy, security, and other aspects; and good practices (Subsection 1.2).

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Health and Consumer Protection DG