A Proposal for a Standard With Innovation Management System

Aurelie Delemarle and Claire Auplat
product on the market and that one of them is by shaping the framework to take these specificities
(using Callon’s terms, to some overflowing) into consideration:
� As NST are a global phenomenon, actors cannot only play at the national level.
� As they are trans sectorial, issues cannot be dealt with only at one industry level
� As they generate social and health issues, public policy makers and other actors who are not
experts in the field need to be included in the process.
4. Regulatory frameworks
In this paper, we first present the existing mandatory frameworks (Table 1) that could be used as the
basis for a nanotechnology market. We show how some overflowing happens and how actors are
trying to develop new frameworks.
Table 1: List of frameworks
Mandatory Frameworks
REACH, EU, 2006 No specific to nanomaterials although a
NanoReach is planned in 2012
Novel Food Regulation, EU, 1997 No specific to nanomaterials
Cosmetic products Regulation, EU, 2009 Adaptation of existing regulation made specific
for nanomaterials
Toxic Substances Control Act Inventory Status Carbon Adaptation of existing regulation made specific
Nanotubes, US, 2008
for nanomaterials
Federal Insecticide, Fungicide, and Rodenticide Act, Adaptation of existing regulation made specific
US, 1996
for nanomaterials
DTSC chemical call-in: carbon nanotubes, US - Adaptation of existing regulation made specific
California, 2009
for nanomaterials
The Manufactured Nanoscale Health & Safety Adaptation of existing regulation made specific
Ordinance, US - Berkeley, 2006
for nanomaterials
OSH Framework Directive, EU, 1989 Adaptation of existing regulation made specific
for nanomaterials
NIOSH Occupational Exposure to Titanium Dioxide, Adaptation of existing regulation made specific
US, 2011
for nanomaterials
French Code de l'Environnement, France, 2010 Adaptation of existing regulation made specific
for nanomaterials
Voluntary frameworks
Voluntary Reporting Scheme for Manufactured
Creation
Nanomaterials, UK, 2008
Nanoscale Materials Stewardship Program, US, 2008 Creation
UK Responsible NanoCode, UK, 2008 Creation
Nano Risk Framework, 2007 Creation
BASF Code of Conduct, 2007 Creation
EU Code of Conduct for Responsible Nanoscience &
Creation
technology Research, 2008
Soil Association Organic Certification - Standard on
Creation
Nanotechnology, UK, 2008
ISO TC 229, 2005 Creation
4.1 Mandatory frameworks
4.1.1 REACH, The Registration, Evaluation, Authorization And Restriction Of Chemical Substances -
EC 1907/2006 – 2006
REACH is a comprehensive regulatory framework which was introduced by the European
Commission in 2006 to replace some 40 existing legal acts and to create a single system for all
chemical substances in Europe. Its main objective was to improve the protection of human health
and the environment through the better and earlier identification of the intrinsic properties of chemical
substances, and this included the plan to find substitutes for the most dangerous chemicals currently
in use. Starting in June 2008 and before the deadline of June 2018, all firms that manufacture or
import more than one tonne of a chemical substance per year are required to register it in a central
database – the European Chemical Agency (ECHA). REACH is a general framework and it does not
apply specifically to nanosubstances. REACH can in fact apply to substances produced or imported in
volumes below 1 tonne per year if they are considered to be of very high concern. This means in
143