Regulatory Review Nanomateials

EU Commission's Communication on the Second Regulatory Review on Nanomaterials

Nanomaterials: Commission Communication proposes a case-by-case approach to assessment, no major legislative amendments; the accompanying Staff Working Paper provides a useful description of assessments made for specific materials.

On 3 October 2012 the European Commission adopted its long-awaited Communication on the Second Regulatory Review on Nanomaterials.

In essence, the Commission considers that, with few exceptions described below, the existing legislation is sufficient to address nanomaterials and potential risks are best addressed by "upstream" legislation such as REACH and CLP.

Overall, REACH is considered adequate to cover nanomaterials (and the current tonnage-based deadlines are considered appropriate). Some of the REACH Annexes may need to be amended, and it is expected that ECHA will adopt guidance on treating nanomaterials for purposes of data sharing. Additionally, because nanomaterials are considered similar to normal substances, in that some may be toxic and others may not be, the Commission considers that it is not necessary to adapt the rules for chemicals safety assessments. 

Outside REACH:

• the Commission will conduct a final assessment on the potential review of occupational health and safety legislation in 2014;
• labelling related to nanomaterials is proposed for medical devices and considered for other regulatory schemes where ingredient labelling exists;
• the Commission is revising the process of selection of priority substances under the water legislation and the relevant BREFs for the industrial emissions legislation.

In response to numerous calls for the establishment of a nano-related register, the Commission will establish a web platform with references to all relevant information sources, including registries where they exist. Hence, for the moment, a EU-wide nanoregister is not proposed.

Last but not least, the EC Communication is accompanied by a Commission Staff Working Paper on "Types and uses of nanomaterials, including safety aspects". The Staff Working Paper contains a detailed description of nanomaterials currently on the market and of the process employed by the Commission and ECHA in assessing information currently in their possession.

Fieldfisher monitors the changes in the regulatory landscape (and governance more broadly) of nanotechnologies. For more information, please contact us.