Just Out of REACH

The report argues that the REACH regulation is currently ineffective for nanomaterials due to four primary gaps: the lack of a formal definition, the automatic granting of 'phase-in' status based on bulk chemical composition, inadequate tonnage thresholds for registration, and the use of risk assessment guidelines that ignore nano-scale specificities. It concludes that non-binding guidance documents are insufficient to fix these issues and recommends either amending the REACH text or creating a stand-alone 'nano patch' regulation with a lower registration threshold of 10 kilograms.

• REACH lacks a formal definition of nanomaterials, leaving the decision of whether a substance is a nanomaterial to the discretion of the registrant, which impairs the ability to gather consistent market information.
• Nanomaterials sharing a chemical composition with a bulk 'phase-in' substance automatically inherit that status, delaying registration deadlines to 2013 (for volumes over 100 tonnes/year) or 2018 (for 1-100 tonnes/year), regardless of the nanomaterial's newness.
• The current REACH registration threshold of one tonne per year is too high for nanomaterials, which are typically produced in much smaller quantities, meaning many nanomaterials evade the 'no data, no market' principle.
• Existing risk assessment and testing guidelines are based on traditional bulk substances and fail to account for the unique exposure pathways, uptake, and dose-response relationships of nanoparticles.
• If a bulk substance is classified as non-hazardous, this classification is extended to its nano-form without requiring new data, potentially allowing hazardous nanomaterials to move through their life-cycle without assessment.
• The report argues that modifying non-binding Technical Guidance Documents (TGDs) is insufficient because registrants still retain flexibility in their application, necessitating legally binding changes.
• The report proposes two policy options: modifying the REACH text (including adding a definition in Article 3 and requiring Chemical Safety Assessments for all nanomaterials) or creating a stand-alone 'nano patch' regulation.
• A proposed stand-alone regulation would include a precautionary registration threshold of 10 kilograms to account for the specificities of nanomaterials while limiting administrative burden.

APA

Azoulay, D. (2012). Just Out of REACH. Center for International Environmental Law. https://www.ciel.org/wp-content/uploads/2014/10/Nano_Reach_Study_Feb2012.pdf

Chicago

Azoulay, David. Just Out of REACH. Center for International Environmental Law, 2012. https://www.ciel.org/wp-content/uploads/2014/10/Nano_Reach_Study_Feb2012.pdf.

Wikipedia

{{cite report |last1=Azoulay |first1=David |title=Just Out of REACH |publisher=Center for International Environmental Law |date=6 February 2012 |url=https://www.ciel.org/wp-content/uploads/2014/10/Nano_Reach_Study_Feb2012.pdf |access-date=17 August 2026 |via=Climate Insights Directory}}

BibTeX

@techreport{azoulay2012just, author = {Azoulay, David}, title = {{Just Out of REACH}}, institution = {Center for International Environmental Law}, year = {2012}, month = feb, url = {https://www.ciel.org/wp-content/uploads/2014/10/Nano_Reach_Study_Feb2012.pdf}, urldate = {2026-08-17}, note = {Indexed by Climate Insights Directory} }