Corporate Banner
Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

The EU Definition of Nanomaterials – Getting what you wished for?

Published: Tuesday, May 01, 2012
Last Updated: Tuesday, May 01, 2012
Bookmark and Share
NanoSight’s Jeremy Warren, CEO, offers the latest news and views on the EU definition on nanomaterials.

Since first citations of the term “Nanotechnology”, scientific, industrial, public and political stakeholders have called for a robust regulatory framework to address the potential toxicological concerns surrounding these exciting new materials.

It is the promise of novel and useful properties from nano sizes of familiar materials that prompts a reappraisal of our knowledge of their potential toxicology and environmental impact.   These are effectively new materials.  The argument goes that, without public and political confidence, this new science risks fear and distrust, rather than being embraced as providing a multitude of solutions to challenges in the fields green energy, world food production or pharmaceutical advancement, to name but a few.

In October 2011 the EU Commission published a recommended definition of Nanomaterials (1). This definition is not the complete framework, but it is a significant step towards it.  Observers of embryonic nanotechnology regulation recognised this definition as the missing jigsaw piece in planned legislation; witness the French government largely adopting the definition’s wording and getting draft legislation on compulsory labeling of Nanomaterials out for consultation in under three months. Meanwhile other stakeholders in fields including nanomaterial manufacture and workplace exposure, handling, labeling, transportation and environmental fate now find they have an authoritative definition to slot into nascent regulation.

The key points of the definition are these:

1)    It is a Nanomaterial if any of these three criteria are met:
a)    At least 50% of the particles by count have one dimension external between 1 and 100nm.
b)    The material has a surface area greater than 60m2/cm3.
c)    The substance appears on an “include” list that captures materials such as graphene, which would otherwise fall outside the definition.
2)    The definition includes naturally-occurring as well as manufactured and incidentally manufactured particles.
3)    There are no specific recommendations on characterisation methods to meet these specifications.
4)    The definition is a recommendation, not a regulation; however its provenance bestows authority.

Despite protracted and energetic attempts by SCENIHR (the Scientific Committee on Emerging and Newly Identified Health Risks, part of the Directorate General for Health and Consumers) to draw stakeholders into consultation, much of industry and the scientific community appear taken by surprise here.  One can sympathise with the compliance officers in, for example, tyre manufacture or cement production, which suddenly find themselves within the nanotechnology industry.

Sympathize one might, but now a period of reflection is required to understand the scientific logic that generated this definition.

Reading back through SCENIHR’s publication, “Scientific Basis for the Definition of the Term “Nanomaterial”, they describe in depth the reasoning behind the definition. SCENIHR exhaustively discuss the possible measures and their benefits, and make clear the large areas of ambiguity and difficulty in these judgments.  Then, with some moral courage, they draft this definition, and in so doing take a step forward in supplying the urgent need for regulation.

The 100nm upper limit is essentially historic, coming from original definitions in nanotechnology.  It was arbitrary then, and is so now, but it is a start point.  Given this definition is specific to regulation, these numbers have to be precise to be enforceable.   Specifying count rather than weight per cent recognises that chemical reactivity increases per mass dose for smaller particles.  Parameters more closely relating to potential toxicity are missing – these are likely to follow on from this initial size-based definition. Regarding the lack of recommended characterisation methodologies, one need look no further than diesel combustion emissions or the water industry for precedents, where regulatory need sets scientists a measurement challenge – and maybe that is the right way to drive development of practical measurement methodologies?

Let me clearly state my interest here – NanoSight’s NTA (Nanoparticle Tracking Analysis) is at least a partial solution to the nanoparticle counting requirement, and in combination with occasional electron  microscopy to inform the bottom end of the 1 – 100nm range, we have a unique and practical, readily-implementable solution.

As the dust settles following the initial publication, reflect on the significant positive drivers from industry in support of legislation; Big business surely seeks to see nanotechnology de-risked?  Potential adverse public reaction hangs over nanotechnology, limiting investment and curbing strategic intent.  More cynically perhaps, big business deals better with regulation than SMEs; here is a barrier to entry that will ultimately lead to profitability in this sector.

To conclude, we welcome this definition as a starting point to deliver regulation on potential toxicity.   There is much research work to be done, and having this definition, this building block in place, will surely enable government investment in research to go the next steps, from simple physical parameters to the far more complex challenges of bioavailability and bio interaction at the heart of toxicology.  If industry and regulators can get this right, then far from labeling “contains nanomaterial” being in the smallest permissible font, we might see “Contains Nano” in a bright splash of colour, implying progressiveness, advanced and useful technology,  and above all, trustworthiness.

Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 4,000+ scientific posters on ePosters
  • More Than 5,300+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

The Jagiellonian University Uses NTA to Characterize Catalytic Nanoparticles
NTA used in the Faculty of Chemistry for the characterization of catalytic materials in environmental applications.
Thursday, July 11, 2013
The Institute of Water Resources & Water Supply Implements NTA to Characterize Colloids in Water
Professor Mathias Ernst has adopted the use of NTA technique to provide new insights into water quality.
Wednesday, June 26, 2013
Caltech Uses NTA to Characterize New Therapeutic Nanoparticles
Caltech to study nanoparticle-based therapeutics for the treatment of dementia, Parkinson's and Alzheimer's diseases.
Wednesday, May 01, 2013
Method Development to Estimate the Purity of Vesicle Preparations
Nanoparticle tracking analysis is used to estimate the purity of vesicle preparations at the Cardiff University School of Medicine.
Thursday, February 28, 2013
Polymer Nanoparticles Used as Drug Carriers Characterized Using Nanoparticle Tracking Analysis
NanoSight reports on how Nanoparticle Tracking Analysis, NTA, is used to help with the characterization of polymeric nanoparticles synthesized as drug carrier systems.
Tuesday, February 12, 2013
NanoSight Announce New Appointment
Leading UK scientist, Dr Andrew Shuttleworth, joins NanoSight board as Director of Diagnostic Sciences.
Tuesday, June 26, 2012
NanoSight to Receive Queen's Award for Enterprise
Company announced it has been selected to receive the Queen's Award for Enterprise in the category for International Trade 2012.
Wednesday, May 02, 2012
Duke University Uses NTA to Characterize "Nanoconstructs" for Biomedical Applications
NTA to characterize metal nanoparticle construct materials for use in biosensing, imaging and cancer therapy.
Friday, April 20, 2012
“Nanomaterials” Defined by European Commission
Watchers of European legislation will recognise this as a watershed and a major move which will have consequence outside Europe.
Thursday, December 15, 2011
NanoSight wins Technology World's 2011 Business Innovation Award
The technology manufacturers are winners of this year's Technology World's 2011 Business Innovation Award in the category of Energy & Environment after receiving a record number of entries surrounding their optical detection and real time analysis of sub-micron particles.
Tuesday, December 06, 2011
NanoSight Recognized as the UK's Fastest Growing Biotech Company
Company has been ranked Fast 50 in the Deloitte 2011 UK technology ranking.
Thursday, November 17, 2011
NanoSight Latest Interactive Webinar: September 22nd Subject: Exosome Characterization by Nanoparticle Analysis
Latest webinar aimed at those with a similar interest in the detection and speciation of exosomes and micro-vesicles.
Friday, September 09, 2011
Landmark Publication Reports Potential of Exosomes as Biomarkers for Early Disease Detection
NanoSight reports the new publication in one of the most cited peer reviewed journals in nanoscience and nanotechnology, NanoMedicine.
Thursday, July 07, 2011
NanoSight announces interactive webinar on January 27th on Exosome Characterization by Nanoparticle Tracking Analysis
NanoSight, world-leading manufacturers of unique nanoparticle characterization technology, will host an interactive webinar on the subject of exosome characterization by Nanoparticle Tracking Analysis.
Thursday, January 20, 2011
Scientific News
Big Genetics in BC: The American Society for Human Genetics 2016 Meeting
Themes at this year's meeting ranged from the verification, validation, and sharing of data, to the translation of laboratory findings into actionable clinical results.
Stem Cells in Drug Discovery
Potential Source of Unlimited Human Test Cells, but Roadblocks Remain.
Automated Low Volume Dispensing Trends
Gain a better understanding of the current and future market requirements for fully automated LVD systems.
Personality Traits, Psychiatric Disorders Linked to Specific Genomic Locations
Researchers have unearthed genetic correlations between personality traits and psychiatric disorders.
Forensic 3D Documentation of Skin Injuries
In this study, the validity of using photogrammetry for documenting injuries in a pathological context was demonstrated.
3-D Printed Dog’s Nose Improves Vapor Detection
By mimicking how dogs get their whiffs, a team of government and university researchers have demonstrated that “active sniffing” can improve by more than 10 times the performance of current technologies that rely on continuous suction to detect trace amounts of explosives and other contraband.
New Markers for Forensic Body-fluid Identification
University of Bonn researchers have successfully identified specific Micro-RNA signatures to help forensically identify body fluids.
Genetics Control Regenerative Properties Of Stem Cells
Researchers define how genetic factors control regenerative properties of blood-forming stem cells.
Major Neuroscience Initiative Launched
Tianqiao and Chrissy Chen Institute invest $115 million to further expand neuroscience research, while Caltech construct $200 million biosciences complex.
Making It Personal
Cancer vaccine linked to increased immune response against leukemia cells.
Scroll Up
Scroll Down
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
4,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos