Challenges of Regulation and Risk Assessment of Nanomaterials

REACH Implementation Project on Nanomaterials -
RIP-oN2: Information Requirements
Hankin S.M. 1 , Peters S.A.K. 1 , Poland C.A. 1 , Ross B.L. 1 , Varet J. 1 , Aitken R.J. 1
Foss Hansen S. 2 , and Holmqvist J. 3
1 Institute of Occupational Medicine; 2 DTU; 3 Cefic
In the European Union, the REACH chemicals regulation effectively shifts responsibility from
authorities to industry to gather information on chemical substances and assess their safety. The
regulation does not currently distinguish between nanoscale substances and their bulk equivalent at
the micro or macro scale. There is also uncertainty over the adequacy of the regulation and the
accompanying guidance for the emerging and rapidly developing nanotechnology industry. As a
result, the means of regulating nanomaterials is under an intense spotlight in the EU.
In 2010, the European Commission launched two REACH Implementation Projects on Nanomaterials
with the purpose of advising how the Information Requirements (IR) and Chemical Safety Assessment
guidance could be updated to better reflect the registration requirements for nanomaterials.
The objectives of the RIP-oN 2 project were to develop specific advice on how REACH information
requirements on intrinsic properties of nanomaterials can be fulfilled, and the information that is
needed for safety evaluation and risk management of nanomaterials, in particular if information is
needed beyond or in addition to the current information requirements listed in REACH Annexes VI-X.
The project commenced with the identification and review of all relevant information sources (Task
A) for carrying out the subsequent Tasks (B1-B5 and C), which included: an analysis of the current
REACH information requirements and testing and whether these requirements are appropriate for
nanomaterials (Task B1); identification of additional relevant specific intrinsic properties for which an
adaptation of the information requirements and testing and other information generation
methods/strategies might be needed for nanomaterials (Tasks B2 & B3); identifying needs for further
research and development of test methods and other information generation methods /strategies in
regard to nanomaterials (Tasks B4 & B5); an outline of the needs and options for metrics/parameters
in the hazard assessment compatible with the exposure assessment parameters/metrics in order to
prepare a meaningful risk characterisation (Task C). Where relevant, additional information
requirements beyond current REACH requirements have been identified when it is considered they
are needed to address adequately the properties of nanomaterials.
Findings from the project, concluding in mid-2011, are being collated to form advice on specific issues
related to nanomaterials for further consideration and integration into the REACH guidance
documents, and to identify further research and development on relevant issues.
22