The Next Steps In Risk Assessment Of Nanomaterials: A Perspective From ECHA | 17646
Occupational Medicine & Health Affairs
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Nanotechnology is a rapidly emerging field described generally as the control and structuring of matter at dimensions
typically between 1 and 100 nanometres to create materials, devices, and systems with fundamentally new properties and
functions. As a result of such novel properties, nanomaterials are anticipated to have applications addressing a wide range of
issues including health and the environment. However, the unique physicochemical properties that make nanomaterials so
useful also make their interactions with biological systems difficult to anticipate and critically important to explore. Recent
studies have shown conflicting results from the traditional assays, methods, and models that are used to assess interaction
of ENM with biological systems. This inconsistency in findings between different laboratories significantly impedes the
integration of research data for risk assessment and public health protection.
In the EU the safety of nanomaterials (NM) is regulated by a legal framework, which implicitly or explicitly (recent
revisions) addresses NM. NM are implicitly covered by the substance definition of REACH Regulation 1907/2006. Under
REACH a registration dossier has to be submitted if a substance is produced/imported in volume higher than 1 ton/year and a
Chemical Safety Report has to be prepared if the volume is higher than 10 ton/year. The registrant has to either explicitly cover
the nanoform in the dossier of the bulkform or submit a specific dossier for the nanoform.
With regard to reliable risk assessments, until now there is still the remaining issue to be resolved of whether or not specific
challenges and unique features existing at the nanoscale have to be tackled and distinctively addressed, given that they may
substantially differ from those encountered with bulk materials.
Zuzana Kloslova is a highly experienced Regulatory Toxicologist and regulatory affairs consultant with expertise in human health risk assessment. Her educational
background has covered publichealth, regulatory aspects of (eco) Toxicology, Biostatistics, Biochemistry, Molecular Biology as well as Organic Chemistry.She has
implemented main EU chemicals management policies (REACH, EU Environment and Health Action Plan 2004-2010, Council Directive 98/24/EC on the protection
of the health and safety of workers from the risks related to chemical agents at work, Council Directive 2004/37/EC on the protection of workers from the risks
related to exposure to carcinogens or mutagens).
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