Proposal for a new legislative framework for regulating nanomaterials
(Nanowerk Spotlight) There is a proposal for a new legislative framework tailored for nanomaterials and their applications called Registration, Evaluation, Authorization, Categorization and Tools to Evaluate Nanomaterials – Opportunities and Weaknesses (REACT NOW).
REACT NOW is the first attempt to present a truly comprehensive and transparent regulatory decision-making framework tailored for nanomaterials.
"It might seem premature to implement a proposal like REACT NOW that is so fundamentally different in the sense that it ends up with semi-qualitative conclusions and non-quantitative estimations about risks," Steffen Foss Hansen at the Department of Environmental Engineering, Technical University of Denmark, tells Nanowerk. "I would, however, argue that we have many of the pieces needed in order to set up a whole new legislative framework for nanomaterials. REACT NOW put them together and provides a flexible and holistic framework that is able to provide timely decision support before the risks of nanomaterials have materialized themselves.
"Furthermore" he adds, "REACT NOW limits the administrative burden on regulators as importers of nanomaterials and producers of nanomaterial products will only register truly necessary applications of nanomaterials, and manufacturers are pushed to innovate and create nanomaterials and products that are truly safe-by-design."
Hansen proposes his new legislative framework that combines registration, evaluation, authorization and categorization of nanomaterials in a commentary in Nature Nanotechnology ("React now regarding nanomaterial regulation").
Hansen argues that many pieces of existing legislative frameworks, in the U.S. as well as in Europe, still hold a vast amount of weaknesses.
For instance, in Europe, there exist several different nanomaterial definitions in areas such as
cosmetics, biocidal products, food and feed, which have all been hard to operationalize.
Complicating any regulatory effort is the fact that there still is no overview of what and how much nanomaterials are produced and used and why.
"Another crucial aspect is that we lack understanding of how different nanomaterials interact with living systems and how to assess the relevant end-points for nanomaterial toxicity and we have a paucity of usable data on, especially, the exposure and environmental hazards of nanomaterials," Hansen points out.
Finally, researchers still lack test methods that would enable safety assessment of the numerous novel nanomaterials.
Under REACT NOW, the following rules would apply:
Manufacturers and importers of nanomaterials are required to register their nanomaterials prior to commercialization, independent of production and import volumes.
For nanomaterials already in commerce, manufacturers and importers should be required to register and fulfil the REACT NOW requirements within six months of the adoption of REACT NOW, whereas product and process activities related to research and development activities are exempted from registration, as is general practice in the EU.
In REACT NOW, a material is considered to be a nanomaterial when >0.15% of the particle size distribution is <100 nm or, for dry materials, when the volume-specific surface area is >60 m2 cm–3, as suggested by the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) (Hansen argues that the reason that SCENIHR’s definition is preferred is that there is a serious risk that some nanomaterials will not be captured by the definition recommended by the European Commission if a 50% threshold is applied, as noted by the European Parliament).
Primary particle size distribution, shape (including aspect ratio), specific surface area and surface treatment are considered unique, which means that any variation of a nanomaterial's size, shape, surface area and surface-treatment that is commercialized has to be identified, named, registered and safety-evaluated separately (This requirement is in line with the recommendation made in 2011 by the “non-industry stakeholders” involved in the so-called REACH Implementation Project on Nanomaterials).
The burden of proof of safety should be placed on industry to ensure that user-relevant data are generated on time.
In order to ensure protection of health and the environment, Hansen recommends that the registrant is required to explain the functional use and effectiveness of their nanomaterial and justify the necessity of the specific use(s) prior to commercialization. In cases of doubt, the European Commission’s Joint Research Centre (EC JRC) should provide technical and scientific support, especially to small- to medium-sized enterprises (SMEs).
"We do not have all the answers to the scientific questions that are relevant to raise, but we know enough to start asking producers and importers to provide information about the nanoform that they produce and/or use in their products," concludes Hansen. "We can provide them with guidance on how to submit this information, which methods to use and how they should explain the opportunities and weaknesses of their characterization and test methods. We also know how to evaluate the applicability of the submitted information and we have clear ideas about how the information itself and the quality of it can be assessed and evaluated and can subsequently provide the basis of an authorization procedure."