How is Nanotechnology Regulated?

Brett Smith, AzO Nano

For a related article on Graphene regulation, see The War on Fake Graphene

Nanotechnology has fantastic potential for addressing a wide range of issues including growing energy demands and challenging diseases. Nevertheless, the use of nanomaterials also raises safety issues, which are being addressed by regulatory bodies around the world.

Functioning at the atomic scale, nanotechnology can provide new or different capabilities that can trigger the creation of new products. The biological, chemical and other effects that make nanotechnology applications so remarkable, however,  may also call for testing to discover any potential impacts on product safety or efficiency.

The use of nanotechnology generally results in product attributes that are different from those of conventionally-manufactured products, and thus assessments of safety or efficiency of regulated products that include nanotechnology should focus on the distinctive qualities and behaviours that nanomaterials exhibit in a particular case. However, regulatory bodies don’t judge all products involving the application of nanotechnology. Agencies will regulate nanotechnology products under their current purview, in accordance with applicable legal standards.

European regulation

In September 2017, the European Commission’s Joint Research Centre (JRC) announced its researchers had considered the legislation of nanomaterials in the EU and recognized essential needs for better implementation, including safety evaluation.

The EU’s existing regulatory framework essentially covers nanomaterials. Legislation on particular products tackles nanomaterials, including needs for labelling on nanomaterials and assessment of the safety of these materials. Other guidelines implicitly pertain to nanomaterials, as the polices addresses all chemicals including nanomaterials. However, as a result of their novel qualities and often new behaviour as opposed to “ordinary” products, there are questions about the safety of nanotechnology and how to evaluate it correctly.

As grounds for a regulatory approach, the European Commission has created a suggested definition of nanotechnology. Currently, it is still a challenge for regulators to recognize and describe nanomaterials, significantly when they have been incorporated into products. The identification is essential for finding out if the nano-specific rules apply. Moreover, since many policies mandate hazard evaluation of nanomaterials before authorising them for use, regulators must confirm that available test procedures and guidance are compatible with nanomaterials and if not, develop nano-specific tests.

The European Commission has said JRC researchers are focused on the reduction of concerns about the effects of nanomaterials on health and the environment and are promoting the creation of a robust regulatory framework by offering informed science-based suggestions. The study concentrates on the development of processes for the detection and characterisation of nanomaterials and on in vitro assessing procedures to evaluate the interaction of nanoparticles with cells.

Regulation in the United States

In the United States, the regulation of nanotechnology largely falls under the auspices of the Food and Drug Administration (FDA) due to safety issues surrounding its use in medicine and personal consumer products.

While the FDA has voiced its support for the use of nanotechnology in innovative new products under its purview, the agency has also said it seeks to establish clear regulatory guideline grounded in existing practices and the available science.

The FDA has said its technical evaluations will be product-specific, considering the effects of nanomaterials from the selected context of each product and its designated use. The FDA indicated that manufacturers should seek advice from the agency early in their development sequence to expedite a mutual knowledge of the scientific and regulatory issues for their nanotechnology products.

When evaluating food additives, the FDA looks to find little to no risk from the intended use of nanotechnology products. Medications, by contrast, are examined not just based on their risk profile but also their expected benefit. These varying legal standards show how different contexts could result in multiple regulatory outcomes, even if two products have the same degree of risk.

FDA has said it will continue post-market tracking of nanotechnology products and taking regulatory action as needed. The agency has emphasized that industry is primarily accountable for making certain its products meet all applicable legal guidelines, including safety standards. As with conventional products, manufacturers are mandated to make sure that their nanotechnology product meets applicable safety standards and complies with other relevant requirements. Therefore, manufacturers should work with current data in product development, and carry on monitoring products after they have hit the market.

As it does with conventional products, FDA will work with domestic and international regulatory bodies on policy issues related to nanotechnology. The federal agency regularly communicates with other agencies to develop overarching federal policies and coordinate policy activities. FDA has also worked in concert with foreign counterparts to share data and opinions on the regulation of nanotechnology products.

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