Biomedical Engineering Reference
In-Depth Information
likely regulate some nanomaterials and nano-containing products too much, and others too little. As
the SCENIHR further pointed out, however, it is not an approach without risks:
… health and environmental hazards have been demonstrated for a variety of manufactured nanomateri-
als. The identified hazards indicate potential toxic effects of nanomaterials for man and the environment.
However, it should be noted that not all nanomaterials induce toxic effects. Some manufactured nanoma-
terials have already been in use for a long time (e.g., carbon black, TiO2) showing low toxicity. Therefore,
the hypothesis that smaller means more reactive, and thus more toxic, cannot be substantiated by the
published data. In this respect nanomaterials are similar to normal chemicals/substances in that some may
be toxic and some may not. As there is not yet a generally applicable paradigm for nanomaterial hazard
identification, a case-by-case approach for the risk assessment of nanomaterials is still warranted.
*
The Commission points out that a single REACH registration can include different forms of
a substance, and the registrant must ensure the safety of all included forms and provide ade-
quate information to address the different forms in the registration. According to the Second
Regulatory Review, only seven substance registrations under REACH and 18 Notifications under
the Classification, Labeling, and Packaging regulation (CLP) have listed nanomaterial as the sub-
stance in the voluntary field. The Commission knows of registrations for substances known to
have nanomaterials that “do not mention clearly which forms are covered or how information
relates to the nanoform. Only little information is specifically addressing safe use of the nanoma-
terials supposed to be covered by the specific dossiers.”
†
The solution to this problem is that the
Commission will review relevant regulatory options in its upcoming REACH review and discuss
possible amendments regarding how to address nanomaterials. In addressing the matter this way,
the Commission might be missing an opportunity to gather information on the “newness” of the
nano form of a substance by requiring a side-by-side comparison of the nano and bulk versions
of the substance in the registration. Further study would not be needed for such a step, and the
information could be very relevant to the key issue in the regulation of nanoforms, namely whether
information on the bulk substance is transferrable in the risk assessment of the nanoform. It is
laudable that the Commission looks to develop best practices for assessing and reporting nano-
materials, but it is likely that the technology already exists for side-by-side comparison of effects
on health. Indeed, the review points to a number of guidances developed on the subject for food,
cosmetics, medicinal products, and medical devices.
‡
The conclusion in the report of the Commission is worth considering at length:
In the light of current knowledge and opinions of the EU Scientific and Advisory Committees and
independent risk assessors, nanomaterials are similar to normal substances/substances in that some
may be toxic and some may not. Possible risks are related to specific nanomaterials and specific uses.
Therefore, nanomaterials require a risk assessment, which should be performed on a case-by-case basis
using pertinent information Current risk assessment methods are applicable, even if work on specific
aspects of risk assessment is still required.
The definition of nanomaterials will be integrated in EU legislation, where appropriate. The
Commission is currently working on detection, measurement and monitoring methods for nanomateri-
als and their validation to ensure the proper implementation of the definition.
Important challenges relate primarily to establishing validated methods and instrumentation for
detection, characterization and analysis, completing information on hazards of nanomaterials and
developing methods to assess exposure to nanomaterials.
Overall the Commission remains that REACH sets the best possible framework for the risk manage-
ment of nanomaterials when they occur as substances or mixtures but more specific requirements for nano-
materials within the framework have proven necessary. The Commission envisages modifications in some
of the REACH Annexes and encourages ECHA to further develop guidance for registrations after 2013.
*
Id.
†
Id.
at 6.
‡
Id.
at 12 -14.
