Last week, the NIA was asked by Chemical Watch (CW article published behid paywall) to provide comments to the recent article by Danish researcher Steffen Foss Hansen ‘React now regarding nanomaterial regulation’ published in NATURE NANOTECHNOLOGY | VOL 12 | AUGUST 2017 | www.nature.com/naturenanotechnology.
The author touches on many of the issues in his commentary that are, and have already been, discussed for a long time by industry, regulatory and policy makers. Many of the particulars of the proposal are valuable and relevant. E.g. the ranking and the implicit concern based approach for risk assessment.
The issues of the definition, which is an underlying complexity for many of the regulatory aspect of nanomaterials is mentioned, and the European Commission is addressing this by revising the definition. We are likely to see a public consultation on the definition in the near future (September?). Another issue also mentioned by the author is the difficulty of applying appropriate test methods. E.g. methods for the definition is being worked upon in the EU NanoDefine project that is coming to an end shortly.
The REACT NOW proposal (Europeans love their quirky acronyms…) is an interesting approach, and aims to be pragmatic. However, in its details there are many issues that are still unclear, nor make sense, e.g. the proposed threshold for what is considered a nanomaterial (as this should clearly follow the EC definition).
There is also an almost philosophical debate that is missing, as there is no reason why nanomaterials, being chemicals, would require a specific dedicated regulatory framework compared to other chemicals, when scientific studies show no evidence of any new hazards that have not already been addressed in conventional chemical risk assessment. The actual nanospecific aspects of the proposal are also limited, as the approach appears to work equally as well for conventional chemicals.
The practical implementation of the proposal seems to suggest that most nanomaterials would require not only registration but also authorization. The proposal, although with best intentions, seems to believe that ‘importers of nanomaterials and producers of nanomaterial products will only register truly necessary applications of nanomaterials’. It is a presumption beyond the remit governments or regulators to define what is ‘necessary’ to be put on the market, creating a dangerous precedent for all sectors. It is clear that producers of nanomaterials cannot place products into the market without there being a specific demand (also rendering the 4th question in the scheme irrelevant).
Finally, REACH, the current chemical regulation has for a long time been actively making progress in revising its nanomaterial specifics. Throwing in a new, substantially different proposal at this point in time after many years of industry, science and government efforts, will likely not fall into the eager hands of regulators.