Tag Archives: nanomaterials definition

Nanomaterials definition for Europe

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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).

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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.

Nanomaterial definitions in Australia

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Australia announced a nanomaterials definition in a Dec. 18, 2010 news item on Nanowerk. The definition will be effective as of Jan. 1, 2011. From the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) document, GUIDANCE ON NEW CHEMICAL REQUIREMENTS FOR NOTIFICATION OF INDUSTRIAL NANOMATERIALS,

NICNAS WORKING DEFINITION1 OF INDUSTRIAL NANOMATERIAL

… industrial materials intentionally produced, manufactured or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 nm and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is nanostructured (i.e. having an internal or surface structure at the nanoscale)”

[Notes to the working definition:

• intentionally produced, manufactured or engineered materials are distinct from accidentally produced materials

• ‘unique properties’ refers to chemical and/or physical properties that are different because of its nanoscale features as compared to the same material without nanoscale features, and result in unique phenomena (e.g. increased strength, chemical reactivity or conductivity) that enable novel applications.

• aggregates and agglomerates are considered to be nanostructured substances

• where a material includes 10% or more number of particles that meet the above definition (size, unique properties, intentionally produced) NICNAS will consider this to be a nanomaterial.]

The document is 15 pages long and goes into details about various categories including exceptions, permit categories, certificate categories, and more. I notice that the 1 to 100 nm range is the standard for this definition. I have never found a good explanation for why this particular range sets the standard. Why not .1 to 150 nm?

As for the Canadian scene, there’s been no final word about the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials since the public consultation closed in Aug. 2010.

European Consumer Groups’ response to public consultation on nanomaterial definition

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The ANEC (The European Consumer Voice in Standardisation) and the BEUC (European Consumers’ Organisation) have issued a joint response to the European Commission’s public consultation, which was open from Oct. 21, 2010 to Nov. 19, 2010 (and mentioned in my Oct. 25, 2010 posting).

From the Nov. 23, 2010 news item on Nanowerk,

1. The proposed size range of up to 100nm is too limited

The Commission draft recommendation foresees basing the term “nanomaterial” on the size range of 1nm to 100nm. Those are also the limits contained in the ISO 27687 standard published in 2008. However, most recent scientific knowledge seems to point out that this size limit seems to be too restrictive and risks that certain nanomaterials will not be properly risk assessed with regard to their potential toxicity.

Recent studies finding that carbon nanotubes can cause the same disease as asbestos fibres received world wide attention (Poland et al. 2008; Takagi et al. 2008). Yet many of the nanotubes in the studies measured >100nm and so would not be considered to be ‘nanomaterials’ using a <100nm size-based definition. Poland et al. (2008) found that two samples of long, tangled multi-walled carbon nanotubes caused asbestos-like pathogenicity when introduced into the stomachs of mice. One of their two samples had a diameter of 165nm and a length of greater than 10µm. Similarly, Takagi et al. (2008) found that in a long term study, more mice died from mesothelioma following exposure to multi-walled carbon nanotubes than died following exposure to crocidolite (blue) asbestos. In this study >40% of sample nanotubes had a diameter >110nm.

Today, we still do not know enough about the new properties of materials at the nanoscale. For this reason, it will be crucial to apply a broad definition to nanomaterials. This is also confirmed by the SCENIHR’s opinion that “there is no scientific evidence to qualify the appropriateness of the 100 nm value”.

The approach to go beyond 100nm has already been followed by some public authorities such as the Federal Office for Public Health and the Federal Office for the Environment in Switzerland which recommend 500nm to be used as the limit of the nanoscale in order to avoid excluding any nano-specific risk.

Concrete examples where a limitation to 100nm may cause problems

– At a workshop on nanotechnologies which had been organised by DG SANCO on 22 October, it has been discussed that in the case of pharmaceuticals the size range of 100nm may be inadequate. As nanomedicines may be at the range of about 1000nm, a definition which is not appropriate for nanomedicines may hamper research and risk assessment. Thus, an EU definition needs to take into account the specific needs of nanomedicines.

– The current REACH legislation shows severe shortcomings when it comes to nanomaterials. We see an urgent need to consider all nanomaterials as new substances under REACH. Moreover, the volume threshold for registration of 1 ton per annum seems to be inadequate for nanomaterials and should be lowered to e.g. 10kg. Limiting the definition of nanomaterials to 100nm could create a new loophole in the future as substances which are slightly bigger than 100nm may escape from the above mentioned requirements that should apply to all nanomaterials.

2. Definition should include agglomerates and aggregates

A definition for regulatory purposes should include agglomerates and aggregates as they often show physiochemicals properties which may pose safety concerns. For this reason we welcome that the Draft Recommendation includes nanoparticles that have a specific surface area by volume greater than 60 m2/cm3.

You can get the entire recommendation (5 pp.) including references from here.

This puts me in mind of Health Canada’s public consultation on a nanomaterials definition. I did put in a submission to the consultation which closed in August and have yet to hear of any results from this process. I did find this notice on their Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials page,

This consultation is now closed. Comments and suggestions received during this consultation period are being considered in any necessary revisions to the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials. Health Canada will make available information to further clarify the use of this policy statement.

Couldn’t they tell us how many responses they got and maybe share a little information?