Tag Archives: European Academies Science Advisory Council

How much more nanomaterial safety discussion do we need?

The report (Impact of Engineered Nanomaterials on Health: Considerations for Benefit-Risk Assessment) from Joint Research Centre (JRC) and the European Academies Science Advisory Council (EASAC) was issued in Sept. 2011 and the authors are still trying to get people to read it. The Aug. 16, 2012 online issue of Nature features correspondence from the authors citing the report,

Our analysis indicates that formulation of a coherent public policy will depend on scientists closing knowledge gaps in safety research, on gathering more data to connect science and regulation, and on training graduate students in nanotechnology research. Policies will need to be flexible to accommodate fresh discoveries in this rapidly advancing technology.

Getting notice for your work can be hugely difficult in an information-rich environment, so it’s not unusual to see efforts continuing over a year or more after publication.  Meanwhile a question persists, how many reports of this type do we need?

Nanomaterials definition for Europe

After all the ‘sturm und drang’ in the last few months (my Sept. 8, 2011 posting summarizing some of the lively discussion), a nanomaterials definition for Europe has been adopted. It is the first ‘cross-cutting’ nanomaterials definition to date according to the Oct. 18, 2011 news item on Nanowerk,

“Nanomaterials” are materials whose main constituents have a dimension of between 1 and 100 billionth of a metre, according to a Recommendation on the definition of nanomaterial (pdf) adopted by the European Commission today. The announcement marks an important step towards greater protection for citizens, clearly defining which materials need special treatment in specific legislation.

European Environment Commissioner Janez Potocnik said: “I am happy to say that the EU is the first to come forward with a cross-cutting designation of nanomaterials to be used for all regulatory purposes. We have come up with a solid definition based on scientific input and a broad consultation. Industry needs a clear coherent regulatory framework in this important economic sector, and consumers deserve accurate information about these substances. It is an important step towards addressing any possible risks for the environment and human health, while ensuring that this new technology can live up to its potential.”

As I understand it , ‘cross-cutting’ doesn’t refer to national boundaries so much as it refers to agency boundaries. Take for example the recent nanomaterial definition (my initial comments in an Oct. 11, 2011 posting) adopted by Health Canada. It is applicable only to Health Canada’s jurisdictional responsibilities. Environment Canada uses a different definition.

As for the new European definition of nanomaterials, Dr. Andrew Maynard offers some interesting observations on his 2020 Science blog in an Oct. 18, 2011 posting (Note: Andrew favours an approach other than the one adopted by the European Commission and was an active participant in the lively discussion that took place),

1.  The inclusion of incidental and natural materials in the definition. The inference is that any product containing or associated with nanomaterials from any of these sources will potentially be regulated under this definition.  Strict enforcement of this definition would encompass many polymeric materials and most heterogeneous materials currently in use.  And the lack of distinction between “hard” and “soft” nanoparticles means that the definition applies to any substance containing small micelles or liposomes – someone needs to check the micelle size distribution in homogenized milk.

2.  The focus on unbound nanoparticles and their agglomerates and aggregates. This makes sense in terms of targeting materials with the greatest exposure potential.  But it may be hard to apply to complex nanostructured materials which nevertheless present unusual health and environmental risks – such as materials with biologically active structures that are not based on unbound nanoparticles (patterned surfaces, porous materials and nano-engineered micrometer-sized structures come to mind).

3.  The threshold of 50% of a material’s number distribution comprising of particles with one or more external dimension between 1 nm – 100 nm. This is a laudable attempt to handle materials comprised of particles of different sizes.  But it is unclear where the scientific basis for the 50% threshold lies, how this applies to aggregates and agglomerates, and how diameter is defined (there is no absolute measure of particle diameter – it depends on how it is defined and measured).

The desire to identify materials that require further action makes sense.  But I do worry that this definition is a significant move toward requiring industry action and providing consumer information in a way that creates concern and raises economic barriers, without protecting health (and possibly taking the focus off materials that could present unusual risks) – in the “do no harm” and “do good” stakes, it seems somewhat lacking.

Andrew does include the full text of the definition and more points of interest in his full posting. I’m very happy to see his comments as they give me some guidance as I get ready to review the Health Canada definition more closely.

ETA Oct. 18, 2011 1500 hours: The European Commission released the Joint Research Centre (JRC) and the European Academies Science Advisory Council (EASAC) presented the findings of a joint report entitled “Impact of engineered nanomaterials on health: considerations for benefit-risk assessment” (pdf). This was an  event designed to coincide with the adoption of a definition for nanomaterials. The Oct. 18, 2011 news item on the JRC-IHCP web site (fully referred to by Nanowerk news) notes,

This fulfils one of the recommendations of the report, which was a call for a precise definition of nanomaterials.

ETA Oct. 18, 2011 1525 hours: I particularly appreciate Andrew’s dry comment about micelle and liposome distribution in milk at the end of his first point.

ETA: NanoWiki offers a roundup of responses in an Oct. 21, 2011 posting.