reportRegulation & Standards
1 Executive Abstract
The present document, as part of the ObservatoryNANO project, is an evolving document, to keep pace with changes in the regulatory landscape (and governance more broadly). It follows two other reports published in the past two years, which provide in-depth information, and includes a detailed description of: regulatory actions in the most relevant application areas of nanotechnologies; activities on nanoregulation in more than 15 Countries worldwide; initiatives related to voluntary measures; standards and international cooperation.
This 2011 report, in addition to the information provided in the two previous reports, highlights the most relevant developments that have taken place in the period June 2010 - June 2011.
Activities and initiatives on Environment, Health and Safety Issues (EHS) as well as Ethical, Legal and Societal Aspects (ELSA) are not taken into account in the report, except where these activities and initatives are clearly in the context of regulation and standards (see ObservatoryNano Workpackage 4 and Workpackage 5 reports for more elaborate information on EHS and ELSA [OBS2, OBS3]).
The information gathered indicates that the European Commission is particularly active in this area and national initiatives tend to align to its indications. In addition, some European countries are pursuing their own specific initiatives.
The developments in regulation and standards during the period considered, included in this report, can be summarised as follows:
- Publication, in EU and countries outside the EU, of working/draft definitions of nanomaterials for regulatory purposes;
- Suspension of the recast of the Directive on food regulation in Europe, that included requirements for nanomaterials (reasons for suspension were not related to nanomaterial issues);
- Adjustment for nanomaterials adopted into chemical legislation in Australia;
- Ongoing review of the application of chemical legislation to nanomaterials (EU, USA, Canada);
- Discussion and development of notification rules, reporting schemes, nanomaterial registers to ensure identification of nanomaterials before they enter the market;
- Achievements in the work on standards (ISO), and the activities of the OECD - WPMN (testing of nanomaterials, database on EHS issues).
Among the main developments expected in the remainder of 2011 are the publication of the updated European Commission regulatory review and the new Action Plan 2011-2015 for Nanotechnologies of the European Commission.
This report confirms that the demand for nanoregulation remains high on the agenda, as the responsible development of nanotechnologies is considered instrumental to their success and the activity in this area is rather intense. So far regulation is still based essentially on existing provisions, albeit under revision to comply with the specificity of nanotechnologies .
Considering the existing gaps in scientific knowledge, the progress of research and the increasing number of applications, the different positions and stances of regulatory agencies around the world, the settlement of this matter cannot be expected in the short term and in any case it will remain a dynamic process. An appropriate balance between hard and soft regulation still seems the most viable option in the short-term.
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