It is popularly believed that the nano industry has entered the mass market and has undergone “consumerization” within the EU. This means that nanotechnology can no longer be considered part of a highly localized niche market, but has evolved from laboratories into being manufactured commercially, and has finally reached the consumers. Don’t believe me? Check out the online inventory of nano-based products, Nanodatabase (www.nanodb.dk). At the end of 2020, a whopping 5000 tangible nano based products were listed in this database! These do not include products that are under development, but products that can be ordered online and is available for purchase anywhere in the EU!

This is an extremely large number of products for a technology that became popular only by the late 1900s. Interestingly, within an EU strategic level, the first mention of “nanotechnology” was within the 5th Research Framework Programme (FP5) for the period of 1998–2002 (European Parliament and Council, 1999). During this period, the EU was just beginning to articulate a possible inclusion and prioritization of nanotechnology within its research and development framework. Since then, the EU market witnessed the boom of nanotechnology; with nanomaterial research and development expanding exponentially and radially. Quite frankly, it has been pretty difficult for regulators and policy makers to keep up with the growing demand of nanomaterials. So, the obvious question we are all asking is, “how can you regulate something that you can barely see and at the same time is taking every industry by storm?” We are talking about a time when electron microscopy hadn’t reached the current resolution or precision. Generalization was not possible, with nanoforms of the same substance exhibiting varying properties and eliciting hitherto unknown effects on the environment and human health.

From what I, as a novice at regulatory methods, gather is that the EU deliberately adopted a rather flexible and elastic “soft regulation” approach towards manufacture, use and import of nanomaterials, providing lot of room for amendments and addendums in the existing regulatory framework. This was particularly important in case of nanotechnology as there is still a lot that is unknown about it, be it in regards to characterization tools or with regards to its safety. The European commission (EC) has been particularly dynamic about regulating nanomaterials, by proactively trying to bridge the gap between consumerization of nanotechnology and development of validated criteria (analytical, scientific and practical) for effective and sustainable legislation.

Initial strides towards regulation of nanomaterials in the EU were made when the EC issued the need for an action plan for safe and responsible development and use of nanomaterials in 2005. It was by the recommendation of this action plan that nanomaterials began to be regulated in 2006, the same way as other chemicals and mixtures within the scope of REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals). However, it was later on in 2008 that the EC via a communication, urged exposure hazard assessment of nanomaterials. This communication provided foundation for Regulation (EC) No 1272/2008 on nano-specific classification, labelling and packaging (CLP) of dangerous substances and mixtures. However, explicit mention of the term nanomaterial was not provided within REACH and nanomaterials were covered under the “substances” definition. This led to ambiguity among registrants, and nanoforms that primarily did not meet the minimum tonnage requirement for substance registration within REACH remained largely unregistered. Additionally, analytical techniques for risk assessment were often economically straining and without a “legal obligation” to register, it was viewed as a waste of resources.

The EC resolved this ambiguity to a certain extent by recommending a definition for the term “nanomaterial” in the year 2011. This recommendation was based on the ISO terminology of “nanomaterial”, a reference report from the European Commission’s Joint Research Centre (JRC), an opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), and 195 contributions received during public consultation. It was the first step taken towards ensuring a “harmonised terminology across different pieces of legislation”. However, this definition was based on the particle size distribution of the material alone. Furthermore, while the EC provided a clear identification criterion for a “nanomaterial”, it was often not easy to measure nanomaterials, thus, making the implementation of this classification scheme rather clumsy. Specific challenges pertaining to lack of validated characterization techniques, reference materials and explicit guidelines led to uncertainties in proper regulation of nanomaterials. Complete and transparent registration of nanomaterials was once again, not achieved. In the meantime, sector specific regulations and definitions of nanomaterials came into force as part of food additives regulation (2008) and cosmetics regulation (2009).

The EC made amendments to the definition of “nanomaterial” again in 2012 and decided that in the absence of a generally applicable guideline for risk assessment, a case-by-case approach may be adopted. The EC also recognized the need for nano-specific amendments of REACH Annexes for legal implementation of these regulations. Yet again, compulsory registration of nanoforms was not mandated. It was also in 2012 that biocidal regulations incorporated “nanomaterials”.

Finally, in 2018, the EC introduced amendments in REACH Annexes I, III,VI, VII, VIII, IX, X, XI, and XII, which came into force since 1st January 2020. According to the revised REACH requirements, all nanoforms have to be registered with special emphasis on chemical safety assessments. Nanoforms of substances must be additionally identified and characterised as part of the registration. Most importantly, risks towards environment and human health are to be assessed using OECD prescribed guidelines, which are either already in place or are under preparation. More refinement of the policies may be required as the industry and its knowledge base continues to grow, however, the EU, as always, has once again set high standards when it comes to preserving the quality of human health and environment. More on the latest REACH requirements on our future blogs! Follow #nNAnoRegulations blogs for more details and information!

For more information regarding test guidelines for nanomaterials and registration requirements, contact me by phone: 06346/9661490 or via email: menon@necotox.de