reportRegulation & Standards
1 Executive Abstract
The present document is the last report of a series developed during the 4 years of the EU FP7 project ObservatoryNANO, to monitor the changes in the regulatory landscape (and governance more broadly) of nanotechnologies. It updates those reports and it includes a detailed description of:
- regulatory actions in the most relevant application areas of nanotechnologies;
- activities on nanoregulation in more than 20 countries worldwide;
- initiatives related to voluntary measures;
- standards and international cooperation.
This 2012 report, in addition to the highlights of the most relevant developments that have taken place in the period July 2011-March 2012 complementing the information provided in the three previous reports, includes also a Commentary about the overall evolution of nanotechnologies governance during the project time (the Commentary is also available as a separate report in the ObservatoryNano website).
Activities and initiatives about 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 initiatives are clearly in the context of regulation and standards, for within the project they are the subject of a dedicated effort (see ObservatoryNano WorkPackage4 and WorkPackage5 reports for more elaborate information on EHS and ELSA).
The information gathered indicates that the European Commission is particularly active in this area and national initiatives of the Member States tend to align to its indications, but also that some European countries are pursuing their own specific initiatives.
The developments in regulation and standards during the period considered by this report can be summarised as follows:
- Publication or revision of definitions of nanomaterials for regulatory purposes (European Commission; Canada; International Cooperation on Cosmetic Regulation, ICCR);
- Publication by the French Government of the final interministerial decree regarding the annual mandatory reporting of "nanoparticulate substances" placed on the market.
- Adoption of the EU Biocidal Products Regulation (BPR) and the provision of Food Information to Consumers (labelling) by the European Parliament, including specifications for nanomaterials;
- Developments of tools and guidelines to put in force the novel Cosmetics Directive in Europe (including specifications for nanomaterials);
- Pre-market notification rules issued by some regulatory agencies for specific nanomaterials (silver nanoparticles, carbon nanotubes (CNT) and others);
- Ongoing review of the application of chemical legislation to nanomaterials (EU, USA, Canada, Australia);
- Publication/revision of tools for risk management of nanomaterials (Switzerland, Denmark, Australia, Korea) and sustainability of nano-related products (UK, USA)
- Achievements in the work on standards (ISO TC 229) and the activities of the OECD Working Party on Manufactured Nanomaterials (WPMN).
Among the main developments expected in the remainder of 2012 are the publication of:
- The revision of REACH for nanomaterials;
- The updated European Commission regulatory review on nanomaterials;
- The possible publication of the EC recommendation for Responsible Research and Innovation (as a follow up of the EC Code of Conduct for responsible nanotechnologies research).
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