Risk Assessment of Nanomaterials in a Regulatory Context

The document examines the challenges of applying traditional risk assessment to manufactured nanomaterials, noting that their unique properties—such as high surface-area-to-volume ratios and ability to cross biological barriers—make existing 'bulk' chemical regulations ineffective. It highlights critical gaps in hazard and exposure data, the lack of standardised testing methods, and the limitations of alternative assessment methods like grouping, read-across, and nano-QSAR. The author concludes that robust risk assessments are currently impossible and urges regulatory bodies, particularly the European Commission, to adopt a precaution-based approach to protect human health and the environment.

• Manufactured nanomaterials (MNM) possess specific properties that distinguish them from 'bulk' forms of the same substance, including a high surface-area-to-volume ratio and the ability to pass through biological barriers in humans and animals.
• Existing regulatory frameworks and risk assessment tools are limited by significant knowledge gaps regarding the environmental and health impacts of nanomaterials, as well as a lack of standardised testing methods and agreed-upon terminology.
• While the OECD suggests most 'bulk' chemical test guidelines are applicable to MNM, there is no scientific consensus on this, with some studies concluding that environmental fate cannot be reliably assessed using these guidelines.
• Alternative risk assessment methods such as grouping, read-across, and nano-QSAR are being explored to avoid the resource-intensive process of case-by-case testing, but they currently lack the necessary high-quality data sets to be robust.
• Grouping approaches for nanomaterials are currently premature and may introduce uncertainty, potentially leading to the over- or under-regulation of substances.
• The European Commission is accused of delaying the implementation of existing legislation and the adoption of new rules for nanomaterials to avoid negatively impacting growth and competitiveness.

APA

Center for International Environmental Law (2016). Risk Assessment of Nanomaterials in a Regulatory Context. https://www.ciel.org/wp-content/uploads/2016/12/NanoRiskAssessmentFactsheetFinal_6dec2016.pdf

Chicago

Center for International Environmental Law. Risk Assessment of Nanomaterials in a Regulatory Context. 2016. https://www.ciel.org/wp-content/uploads/2016/12/NanoRiskAssessmentFactsheetFinal_6dec2016.pdf.

Wikipedia

{{cite report |author=Center for International Environmental Law |title=Risk Assessment of Nanomaterials in a Regulatory Context |date=December 2016 |url=https://www.ciel.org/wp-content/uploads/2016/12/NanoRiskAssessmentFactsheetFinal_6dec2016.pdf |access-date=23 October 2026 |via=Climate Insights Directory}}

BibTeX

@techreport{centerforinternationalenvironmentallaw2016risk, author = {{Center for International Environmental Law}}, title = {{Risk Assessment of Nanomaterials in a Regulatory Context}}, institution = {Center for International Environmental Law}, year = {2016}, month = dec, url = {https://www.ciel.org/wp-content/uploads/2016/12/NanoRiskAssessmentFactsheetFinal_6dec2016.pdf}, urldate = {2026-10-23}, note = {Indexed by Climate Insights Directory} }