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NIA Opinion on JRC's Suggested Options for Nanomaterial Definition Now Available

In its recent report, Towards a review of the EC Recommendation for a definition of the term "nanomaterial": Part 3: Scientific-technical evaluation of options to clarify the definition and to facilitate its implementation, the Joint Research Centre (JRC) suggested a number of options for the review of the European Commission's Recommendation for the Definition of a Nanomaterial. ​NIA applauds the JRC's efforts to conduct a sensible review and develop appropriate options for nanomaterial regulation and terminology.
 
We have conducted a full evaluation of this report and compiled our opinion on the feasibility and scientific grounding of the diverse options described by the JRC. We believe these suggestions provide a path to a reasonable nanomaterial definition and look forward to working with fellow stakeholders on implementation. Our evaluation can also be found in PDF format here.
 

NIA preferred options

2.1. Scope in terms of origin of the materials
NIA preference: option 1: ‘no change’
While there are difficulties arising from the fact that natural, incidental and manufactured nanomaterials are covered in the current definition, NIA believes that narrowing the scope may alter the strength of this overarching document. NIA supports that the definition acknowledges the existence of diverse sources of nanomaterials.
When adapting the definition to a specific EU legislation, EU policy makers should make sure that it is done with consistency in order not to create additional difficulties for companies. 
NIA does not think that option 2: ‘narrow the scope in terms of origin of the materials’ brings solutions to the problems currently raised by the definition.
 
2.2. Particulate matter and nanostructured materials 
NIA preference: option 1: ‘no change’ 
Currently, particulate matter is the only type of material covered by the definition. NIA believes that the focus of this regulatory definition should remain on such materials. 
While nanostructured materials are relevant to the field of nanotechnology, they do not present new challenges to the current regulatory framework, hence NIA believes that Option 3: ‘extension to non-particulate matter/inclusion of nanostructured materials’ is not suitable and should not be retained. 
 
2.3. Size as the only defining property and the selected size range 
NIA preference: option 1: ‘no change’
The size range 1-100 nm is a consensual size range for a definition of a nanomaterial that has been agreed upon in diverse bodies discussing nanotechnology vocabulary including the International Standards Organisation (ISO). An inclusion of nano-specific properties (option 2) in the definition is scientifically very challenging for a number of reasons that are well outlined in the JRC publication (it is extremely difficult and would require companies to conduct complex testing of these properties, for which often no validated methods are available yet). NIA considers that extending the size range to a micrometre (option 3) would be detrimental to the coherence of the legislation. To date, all EU regulation mentioning nanomaterials refer to the 1-100 nm size range. As stated above, the size range 1-100 nm has been used globally and should remain the focus in the European Union.
 
2.4. A fraction of the number of particles as defining threshold 
NIA preference: option 1: ‘no change’
Using a threshold in the definition of a nanomaterial has been challenging to users since it was first introduced: it gives rise to borderline situations where it is difficult to differentiate nanomaterials from their non-nano counterparts. As stated in the JRC report, placing a threshold below the 50% value (option 2) would be problematic since it would allow ‘naming a material after one of its minority components’. NIA believes that the threshold should be fixed at 50%. However, EU policymakers should consider that implementation of this threshold will be difficult as long as reliable measurement methods remain unavailable. The (current) issues in a reliable measuring of number distributions could lead to unintended inclusion of materials in the definition and should be avoided (see section 3.2). 
 
2.5. What are constituent particles and how to measure their size? 
NIA preference: option 1: ‘no change’ or option 3: ‘Adjustment of the definition – specification of the term "constituent particles"’
NIA considers that the inclusion of the term ‘prior’ (option 2) in the proposed definitions of ‘constituent particle’ is not clarifying the definition and introduces even more confusion. It is an important modification of the definition in ISO/TS 80004-2:2015 Nanotechnologies — Vocabulary — Part 2: Nano-objects. 
In Option 3 constituent particles would be defined as ‘particles separable from larger particles’. The addition of ‘separable’ would help to eliminate larger structures. Nevertheless, a pragmatic solution would be required to demonstrate the non-dispersability of a given substance.
 
2.6. Flexibility of the threshold value 
NIA preference: option 2: ‘change the definition’
A threshold value lower than 50% would make it almost impossible for producers to prove that a material is not a nanomaterial; the threshold should therefore remain at the 50% value (see 2.4).
 
2.7. The term "particle"
NIA preference: option 3: ‘amend the definition of the term ‘particle’ in the definition’
NIA agrees that the term particle is currently problematic in the definition. Defining a particle as a ’minute solid piece of matter’ would provide clarity to the scope of this regulation. NIA insists that soft nanoparticles such as micelles should not be included in the definition. The melting temperature can serve as quantitative and conservative criterion of solidity. 
 
2.8. The terms "one or more external dimensions" 
NIA preference: option 2: ‘change to minimum external dimension in the definition’
NIA supports the removal of the formulation ‘one or more external dimensions’. Including a reference to minimum Feret diameter to define ‘minimum external dimensions’ would be useful to users as the current formulation is considered unclear and challenging.
 
2.9. The word "containing" 
NIA preference: option 2: ‘change the wording by using the term ‘mainly consisting’ of instead of ‘containing’’
NIA supports this sensible approach, which would clarify the situation.
 
2.10. The term "unbound" 
NIA preference: option 2: ‘change in the definition by using the term ‘individual entity’ instead of ‘unbound state’’
NIA supports this sensible approach, which would clarify the situation. 
 
3.1. The volume-specific surface area 
NIA preference: option 2: ‘remove VSSA as defining criterion and clarify its role as screening criterion’
A good screening criterion is needed and NIA believes that VSSA would be adequate to fulfil this role as it is a reliable way to identify non-nanomaterials. VSSA could also be used as an independent screening criterion, for example in guidance (see 3.2 below).
 
3.2. How to prove that a material is not a nanomaterial and how to avoid unintended inclusion of materials in the definition?
NIA preference: option 3: ‘use VSSA as independent defining criterion’
NIA agrees that VSSA could be used as an independent defining criterion. Retaining this option would facilitate the alignment of the definition to the realities of industrial actors.
 
3.3 Materials explicitly included in the definition
NIA preference: option 2: ‘extension of the list of materials explicitely included in the definition’ or option 4: ‘remove derogations’
For reasons of consistency, NIA considers that the definition should remain in the size range 1-100 nm and would therefore not agree to option 3 ‘modify the derogation,’ which would significantly override these size limitations. In order to improve the clarity of the derogations, NIA would support either a subtle extension of the list to tubes and plates of other chemical composition than carbon, or a removal of the derogations. 
Other comments 
 
NIA supports the development of guidance on measurement, minimum external dimension and sample preparation mentioned in section 4 and agrees, as described in section 5, that the regulatory purpose of the EU definition does not allow using the ISO definition without any modification. NIA nevertheless urges JRC and the European Commission to take into account the work achieved by ISO’s international group of experts to reach consensus and invites policymakers to consider their definitions for supporting terms.
 
Finally, NIA regrets the absence of some elements of definition in this report: 
  • the JRC does not consider providing additional guidance to defining requirements associated to internal dimensions;
  • the introduction of an upper size limit in relation to the number size distribution is not discussed: above a certain size, most material might be considered to “contain” nanoparticles, but cannot be considered to “consist of” nanoparticles.
  • the challenges of calculating the number of particles are not sufficiently taken into account; and,
  • the definitions of agglomerate and aggregate and the inclusion of these in the definition, while being identified as problematic, are not questioned.
 

 

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