Regulation (Europe)

Code of Conduct for Responsible Nanotechnologies

In 2008, the European Commission passed a recommendation incorporating the Code of Conduct for responsible nanosciences and nanotechnologies research in which the Member States have been urged to follow the suggested code, while adopting and implementing their strategies for developing sustainable nanosciences and nanotechnologies research, in line with the Commission Nanotechnologies Strategy and Action Plan, which were passed in 2004 and 2005, respectively. The code is just one of the now myriads of documents that somehow regulate the subjects. It is true that the recommendation is intended to address the Member States, but the content will be probably transposed into national legislations as is, and therefore will be binding for the entities involved in nanosciences and nanotechnologies research. Additionally, the Commission believed that the code should be adopted soon to ensure that research is undertaken in a safe, ethical, and effective framework. The code is voluntary, and it offers a set of general principles and guidelines for future actions.

Challenges of Nanotechnology Regulation

Like all technologies, nanotechnology needs to be regulated in order to foster sustainable and safe development. The difference between nanotechnology and other fields of technology lies in the framework that regulators are creating or adjusting around the world at the same time. Unfortunately, the approaches followed by regulatory entities, governments, and other stakeholders are not uniform, and therefore a high degree of uncertainty surrounds the production and use of products employing nanotechnologies. The first issue to be solved should be an agreed nomenclature that could be generally accepted. This is an issue that is still under development, and involves the work of the major standardization organizations, like the International Organization for Standardization (ISO).

The fields in which nanotechnologies must be regulated are very broad and for the time being, the application of more general provisions has been considered appropriate by the European Commission. The areas range from environmental law to the safety of workers and consumers, from labeling to the examination of new drugs and devices for medical purposes. In 2009, the Organisation for Economic Co-operation and Development (OECD) hosted a meeting during which the representatives of the nanotechnology industry requested the creation of a clear legal framework to help them shape long-term strategies while at the same time avoiding the creation of an overly-rigid framework that can stifle innovation.

Some point out, though, that the views of the stakeholders sometimes seem quite opposite. In fact, on the one hand, the more cautious would prefer a well-defined regulation that would also create safe harbors for manufacturers, especially in view of potential future product liability issues. On the other hand, others suggest that the wait for a complete legal framework would inevitably stop or slow the pace of current research, and that this would be nonsensical and inappropriate.

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