Securing the Promise of Nanotechnologies: Towards Transatlantic Regulatory Cooperation

Publication Date : 2009
Code : 133
213 Visited Entry Date : 2017/10/07


Volume 122 Pages
Document type Report
Subject Regulatory & Legal Aspect

This report aims to contribute to the debate on how best to address the risks of emerging nanotechnologies and how to promote coordinated and convergent approaches in the EU and US. It presents the main findings of international collaborative project "Regulating Nanotechnologies in the EU and US", which was carried out by a consortium of research institutions from both sides of the Atlantic.

This project set out to provide an analysis of current regulatory developments in the field of nanotechnologies, with a view to informing the debate on transatlantic cooperation and regulatory convergence. The project provides a detailed comparative analysis of EU and US regulatory frameworks in the key areas of chemicals, food and cosmetics, and identifies options and challenges for policy-makers and regulators in promoting greater transatlantic cooperation and convergence in nanomaterials regulation. 




About the Authors


List of Acronyms


Executive Summary


1 Introduction and Overview

   1.1 Background: call for proposals on ‘Policy Approaches to Promoting the Safety of Nanomaterials’

   1.2 Research agenda for this project

   1.3 Research design

   1.4 The concept of regulatory convergence

   1.5 Overview and structure of the report


2 Nanotechnologies and Nanomaterials

   2.1 Terminology: nanosciences, nanotechnologies and nanomaterials

   2.2 Different generations of nanotechnologies

   2.3 Commercial and economic dimensions

   2.4 Environment, health and safety (EHS) risks: scientific knowledge and uncertainty

   2.5 Key regulatory issues and challenges

      2.5.1 Rapid technological change

      2.5.2 Uncertainty of commercialization paths

      2.5.3 Uncertainty regarding nanomaterials risks

      2.5.4 Uncertainty regarding the suitability of regulatory frameworks

      2.5.5 Uncertainty regarding regulatory and scientific resources


3 Relevant National and International Institutions and Regulatory Frameworks

   3.1 The United States

      3.1.1 The US regulatory system

      3.1.2 Key federal entities and regulations

   3.2 The European Union

      3.2.1 Key European entities and regulations

   3.3 International developments

      3.3.1 Intergovernmental cooperation

      3.3.2 International private initiatives

   3.4 Conclusion


4 Chemicals Regulation

   4.1 US chemicals regulation

      4.1.1 The Toxic Substances Control Act (TSCA)

      4.1.2 The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)

   4.2 EU chemicals regulation

      4.2.1 REACH

      4.2.2 Pesticides

      4.2.3 REACH and nanoscale substances

   4.3 Comparing US and EU approaches

      4.3.1 Key factors

      4.3.2 Comparative analysis


5 Food Regulation

   5.1 US food regulations

      5.1.1 Whole foods

      5.1.2 Food additives

      5.1.3 Colour additives

      5.1.4 Residues

      5.1.5 Dietary supplements

      5.1.6 Labelling

      5.1.7 Confidential business information

      5.1.8 Nanospecific regulatory actions

   5.2 EU food regulations

      5.2.1 Novel Foods

      5.2.2 Food enzymes, additives and flavourings

      5.2.3 Food supplements

      5.2.4 Food contact materials

      5.2.5 Labelling

      5.2.6 General concluding remarks on EU food regulation

   5.3 Comparing US and EU approaches

      5.3.1 Nano-specific regulation

      5.3.2 Definitions and product categories

      5.3.3 Pre-market regulatory tools

      5.3.4 Post-market regulatory tools

      5.3.5 Data collection and sharing


6 Cosmetics Regulation

   6.1 US cosmetics regulations

      6.1.1 Labelling

      6.1.2 Confidential business information

      6.1.3 Cosmetics and nanotechnologies

   6.2 EU cosmetics regulations

      6.2.1 The 1976 Cosmetics Directive and amendments

      6.2.2 The proposed Cosmetics Regulation

      6.2.3 Nanomaterials and EU cosmetics regulation

   6.3 Comparative analysis

      6.3.1 Limitations of scope of comparison

      6.3.2 Incorporation of nano-specific regulatory language

      6.3.3 Definition of cosmetics

      6.3.4 Pre-market tools

      6.3.5 Post-market regulatory tools

      6.3.6 Information sharing


7 Promoting Transatlantic Cooperation and Convergence in Nanomaterials Regulation

   7.1 Scientific building blocks for risk assessment

   7.2 Knowledge gaps

      7.2.1 EHS risk research

      7.2.2 Reporting of nanomaterials in commercial use

   7.3 Consumer labelling and ethical concerns in risk management

      7.3.1 Consumer labelling

   7.4 Conclusion: the way forward for international coordination and regulatory convergence


  • Royal Institute of International Affairs (Chatham House) Published by
Related Document