ABSTRACT

This chapter starts exploring the first of the four phases of REACH, i.e. Registration, which can be considered the gateway to the REACH system. Industry, according to REACH, must bear the burden for generating safety data on both new and existing chemicals, otherwise no access to the EU market is to be granted. Known also as the ‘no data, no market’ principle, this provision, which to some extent shifts the duty to gather and assess toxicity data to private entities, is one of the main features of the REACH framework. Chapter 3 offers a detailed analysis of the cornerstone concepts of REACH such as ‘substance’ definition, registration deadlines, the tiered system of production and the correlated incremental data requirements – and the implications of such elements for the registration of nanosubstances. Although REACH is currently nano-silent, amendments to its Annexes that incorporate specific nano-provisions have been adopted in 2018. This chapter concludes by advancing the idea that such amendments are barely sufficient for the effective and appropriate capturing of nanoscale chemicals under the REACH regulatory framework in general, and its Registration phase in particular.