At the time that REACH was being drawn up, the issue of nanomaterials was only in its infancy, so no specific provisions were adopted in the REACH Regulation to address them. While everyone recognises the important industrial and competitiveness potential of nanomaterials, the uncertainties over their potential impact on human health and the environment are also highlighted, triggering calls for a review and possible adaptations to the regulatory system in place. With respect to REACH, the Commission has started to consider possible legislative changes; however, these are likely to take several years to materialise. In the meantime, some Member States are considering initiatives to impose national rules, including reporting schemes and labelling requirements. The legality of these measures is questionable, however, considering that REACH today applies to nanomaterials, as also to any other chemical substance and that the REACH Regulation is regarded as totally harmonising the market access conditions for chemical substances in the EU.
Our article summarises the current regulatory status of nanomaterials under REACH and specifies the legal framework under which the legality of national initiatives contemplated by the Member States to regulate nanomaterials must be reviewed. It is the view of the authors that Member States cannot rely on the argument that REACH does not contain specific provisions on nanomaterials, nor require registration of substances manufactured or imported below 1 tonne, to consider that the matter is not totally harmonised under EU law and thus justify the adoption of national measures to regulate nanomaterials. However, Member States can use the REACH processes, including the evaluation, authorisation and restriction processes to propose conditions for or restrictions of the marketing and use of nanomaterials at the EU level, in the conditions specified in the Regulation. They can also trigger the application of the safeguard clauses of REACH and of the Treaty on the Functioning of the European Union. It is only within that strict framework that reference to the precautionary principle can be made to justify the introduction of national measures.