Classification Strategies for Regulatory Nanodefinitions - Safety of Nanomaterials along Their Lifecycle - page 55

In the lack of technical guidance on the terms “novel,” “intentional,” “manufac-
tured,” “engineered,” these cannot be enforced and the next iteration of guidance
should replace these terms by a well-defined technical term that is at least neutral
toward innovation. One can also anticipate that the development of methods and
tiered guidance from now until 2017 will suggest modifications to the elements of
the definitions, based on field evidence of materials, products, methods, and costs.
In view of severe persisting limitations, the technical guidance must be based on
a substance- and method-specific decision-tree and measurement strategy, such as
developed by the NanoDefine FP7 project by 2017.
Some very first modifications to be implemented by a suitable guidance have
been addressed in this chapter, including the practical but scope-limiting “best
possible dispersion” approaches, the inconsistent treatment of aggregates and
nanoporous materials, and the wider use of techniques other than EM, including
further the general validity ranges of methods for powders and suspensions, the
concepts of grouping and tiered measurement strategies with integrated validity
checks.
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