Regulatory Review Nanomateials
08 October 2012
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.
Field Fisher Waterhouse monitors the changes in the
regulatory landscape (and governance more broadly) of
nanotechnologies. For more
information, please contact
us.