First of all, a distinction needs to be made in the legal text of REACH between the bulk and the nano form of a given material and Hansen argues that the European Commission should acknowledge that nanomaterials cannot be identified solely by chemical composition. Additional main identifiers (such as primary particle size distribution, shape – including aspect ratio – specific surface area and surface treatment) are needed as this is the only manner in which it can be made clear that the properties and behavior of nanomaterials differ fundamentally from each other and from the bulk material.
Specific substance identification of nanomaterials could mean that some would not meet REACHís tonnage bands, which lay down the environmental, health and safety (EHS) information requirements that need to be met by industry and hence Hansen argues that lowering the tonnage band would have to be a fundamental second strategic step toward revising REACH: If nanomaterials are commercialized in Europe then their registration should be independent of production volumes, and submission of physicochemical characterization and (eco)toxicological data to regulators should be mandatory.
In addition, registration fees should be reduced for producers of nanomaterials given the urgency of generation environmental, health and safety data on nanomaterials and the European Chemical Agency (ECHA) should offer confidential technical assistance to small- and medium-sized enterprises to meet these new information and data requirements to ensure the innovation of safe nanomaterials.
Tajani argues that substance identification is only one element and that trying to identify unambiguous rules for substance identification is probably elusive and might result in ever more complex rules on what is considered as the same substance as opposed to different substances, without necessarily resulting in more safety of nanomaterials. Instead, Tajani and the European Commission wish to focus on clarifying what is needed to demonstrate the safe use while also noting that the implementation of regulatory changes would take several years and hence is not desirable.
Tajani furthermore argues that Hansen fails to explain why lower thresholds for REACH registration should apply to nanomaterials compared to other chemical substances as "there is no evidence that nanomaterials as a category of substances are more hazardous than other chemical substances, nor that the risks of hazardous nanomaterials are more severe than those of conventional hazardous chemicals". To support this argument, Tajani refers to the conclusion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) that nanomaterials as a category are not more or less hazardous than other chemicals.
Here Hansen refers to the Staff Working Paper ("Types and uses of nanomaterials, including safety aspects"; pdf) that accompanies the European Commissionís Second Regulatory Review on Nanomaterials published in October, 2012. In contrast to Tajani's argument, the Staff Working Paper acknowledges that nanomaterials may have a wide range of potential toxic effects, that there are few measured exposure data and that few environmental fate and behavior studies are available. It concludes that "Örisk characterisation and combining hazard and exposure data necessarily remains at a very preliminary and qualitative level."
"One can only hope that Tajani is incorrect when he argues that this is no different for chemicals in general, because then the situation is very dire," says Hansen. "SCENIHR might have stated that nanomaterials as a category are not more or less hazardous than other chemicals based on the evidence available at the moment, but this fails to recognized that there is limited EHS-information and data available."
Furthermore, Hansen points to the fact that SCENIHR has also stated that there are currently no standardized (eco)toxicity test guidelines in use and that monitoring and detection equipment for exposure assessment need to be developed and there are no standards on how to measure nanoparticle dose in humans, the workplace and the environment. This is in sharp contrast to most other chemicals.
The notion that "Önanomaterials are similar to normal chemicals/substances in that some may be toxic and some may not" highlights the fact that manufacturers, scientists and the European Commission just don't know which nanomaterials are toxic – just as we did not know about the risk of industrial chemicals before they came into widespread use during the twentieth century, resulting in significant human health and environmental damage as extensively documented by the European Environmental Agency.
Hansen argues that there is a risk that the European Commission either does not understand the challenges and problems before them when it comes to regulation and risk assessment of nanomaterials, or they grossly underestimate them.