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Health and nanotechnology: Regulation in the EU

In terms of nanotechnology regulation, the European Union is well-advanced but not alone in seeing the need for greater scrutiny on the use of nanotechnologies for medical purposes. To facilitate regulation, inter alia, a definition of nanomaterials has been defined by the European Commission in its Recommendation on the Definition of a Nanomaterial - 2011/696/EU. This non-binding document has also been used by other pieces of regulation to define the term ‘nanomaterial’.

The table below lists some key regulatory documents within the European Union, centrally and within Member States.
 

Status Name of the document Country/Region Scope Nano-specific
Implemented Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) - 1907/2006(EC) EU Chemicals & Raw Materials,Excludes medicinal products from some requirements,Excludes substances used in medical devices from some requirements. No, but ‘substance’ covers nanomaterials
Under review Regulation on Medical Devices - 2012/0266(COD) EU Medical devices Yes
Implemented European Commission Recommendation on the Definition of a Nanomaterial EU Medical devices and pharmaceuticals Yes
Implemented Nanomaterials in the Healthcare Sector: Occupational Risks & Prevention - E-fact 73 EU Medical devices and pharmaceuticals (also wider healthcare) Yes
Implemented Decree on the annual declaration on substances at nano-scale - 2012-232 France Substances at the nano-scale (including medicinal products) Yes
Adopted Royal Decree regarding the Placement on the Market of Substances manufactured at the Nano-scale Belgium Substances manufactured at the nano-scale (excluding those used in medicinal products and medical devices) Yes
On-going Draft Order on a Register of Mixtures and Articles that contain Nanomaterials as well as the Requirement for Manufacturers and Importers to report to the Register Denmark Nanomaterials (excluding those used in medicinal products and medical devices) Yes

 

There are also efforts underway within the research community to develop a testing strategy for engineered nanomaterials such as those used in some health and cancer treatment applications. These include the ITS-NANO project under FP7-NMP which seeks to establish a roadmap for the development of advanced tools and databases that help to assess the risks through knowledge-based decision making.1

In addition, nanotechnologies are impacted by the work of the International Organisation for Standardisation ISO (ISO/TS 80004-7:2011 Nanotechnologies - Vocabulary -- Part 7: Diagnostics and therapeutics for healthcare) and by that of the US Food and Drugs Administration (FDA), see below.

Regulation in the rest of the world

A 2013 publication of the OECD on the Regulatory Frameworks for Nanotechnology in Foods and Medical Products2 disclosed the results of a survey on 10 OECD delegations from the EU, France, Germany, the Netherlands, Poland, Canada, Japan, Norway, the Russian Federation and the USA. According to this survey, all the aforementioned delegations have frameworks ‘governing the manufacture, importation and commercialisation/marketing for medical products relevant to nanotechnology’. All of them also stated that they had ‘published (or articulated) a regulatory approach to nanotechnology’; these approaches are not systematically reported in the document. The OECD concluded that, in the countries of the responding delegations, the existing frameworks already cover medical products that may contain nanomaterials or involve the application of nanotechnology.
 


1. http://www.its-nano.eu
2. OECD (2013), “Regulatory Frameworks for Nanotechnology in Foods and Medical Products: Summary Results of a Survey Activity”, OECD Science, Technology and Industry Policy Papers, No. 4, OECD Publishing. http://dx.doi.org/10.1787/5k47w4vsb4s4-en