Regulation of Nanoparticles under REACH

On 30 October 2008, the European Commission (EC) circulated a draft document regarding the registration of nanomaterials under REACH [17]. According to the EC, the aim of this document is to address the key questions related to the registration of nanomaterials in REACH in order to advise on how to deal with nanomaterials in the registration and in the related discussions in pre- Substance Information Exchange Forum (SIEF) and in SIEF in coherent and comparable manner. [18] 

Other examples of several scenarios are provided, including a discussion in Section 3.3 of the EC document which addresses the question of how to identify when a nanomaterial is a nanoform of a substance as opposed to when it is a distinct substance. The guidance states  

Tn case the hazard properties differ considerably, a separate classification and labelling as well as a dossier of the nanoform would be justified for the registration of the substance. 

In case the properties of nanomaterials of various structure, shape, surface, morphology, etc., differ significantly from each other and, a registration of the nanomaterial as a distinct substance would be justified. [19] 

The current guidance for nanomaterials as discussed herein is currently considered to be in draft form, and the EC states that there is a need to develop criteria and ways which will allow potential registrants to distinguish between cases where a nanomaterial is a nanoform of a substance and when it is a distinct substance. 

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Chapter 7 discusses regulation of nanoparticles under REACH and TSCA. Chemical identity/nomenclature issues and risk assessment for nanoparticles are included in this discussion. The book therefore concludes with this new chemical technology that has enormous potential in commercial uses and benefits such as in medical applications, and the potential for harm to humans and the environment due to its unique physical state. EPA and ECHA have commented on how they plan to regulate nanoparticles, and the former has begun to do so, but this is one area where traditional and existing regulatory schemes (and even the science used to determine risk) may be insufficient. 

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