Challenges of Regulation and Risk Assessment of Nanomaterials

Nanomaterials in the Regulatory Development: an EU Perspective
Kobe A. 1
1 Unit D.3 Chemicals, Pesticides and Nanomaterials, DG Environment, European Commission
When identifying the EU perspective, one needs to be aware that there is no overarching
'documented' EU perspective on nanomaterials shared by all principal EU actors: the European
Commission (the Commission), the European Parliament (EP) and the Member States. The overall
Commission Policy for Nanotechnology was expressed in the Commission Communication 'Towards a
European strategy for nanotechnology' and in the Action Plan 2005-2009 on safe, integrated and
responsible development of nanotechnologies. The Commission is currently preparing a plan for the
next five year period. Its current draft importantly builds on the last Action Plan, outlining three
major strands that need to be further addressed through a coherent approach: science & innovation,
safety & regulation, and societal aspects.
The Commission ambition for the safety & regulation strand continues to be set by the EU Treaty that
explicitly requires that the EU policies shall aim at the high level of protection (of human health and
the environment). It also strives to ensure that the design of its legislative proposals as well as the
implementation of adopted legislation achieve this goal in a most cost-efficient manner, fostering
competitiveness and innovation. In 2008 the Commission adopted a Communication concluding that
the existing legislation in principle already covers the safety aspects of nanomaterials, and that the
protection of health, safety and the environment needs mostly to be enhanced by improving
implementation of current legislation as well as further research. For more general reasons, the
Commission also commenced the work on the definition of nanomaterials that could be used across
the EU regulatory framework.
Some Member states are presently developing or considering national nano-specific regulation.
These may influence the EU perspective that always takes into account subsidiarity, regulating at EU
level only when the objectives cannot be achieved effectively by national approaches.
In 2009, the EP adopted a resolution expressing scepticism towards the Commission's 2008
conclusions, requesting a more solid and in-depth review of legislation (specifically mentioning
environment - REACH, waste) and "an inventory of the different types and uses of nanomaterials on
the European market". In its role as the legislator, the EP in the recent years consistently pushed (and
in some cases succeeded) to introduce nano-specific provisions in the EU legislation.
A number of nano-related regulatory reviews and activities launched by the Commission are
currently ongoing, and some will be discussed at the Workshop. The Commission is planning to issue
by the end of 2011 the second Communication on the regulatory aspects of nanomaterials, together
with an annex on the information on nanomaterial types and uses, including safety aspects. The
Communication will most probably also include needs on further research and science-based
implementation guidance. Further important regulatory reviews are scheduled in 2012 (e.g. REACH).
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