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Regulations of Nanotechnologies

Nanomaterials enable exciting new technologies. Is it also problematic? What are the regulations of nanotechnologies?

Nanotechnologies are...

nano particle

According to the Oxford Languages Dictionary, the definition of nanotechnology is “the branch of technology that deals with dimensions and tolerances of less than 100 nanometers, especially the manipulation of individual atoms and molecules.”  Nanotechnology enables molecular manufacturing. To put it into perspective, it is 100 000 times smaller than the diameter of a human hair. Nanomaterials are the components of nanotechnology. Indeed, particles of nanoscale dimensions are the elements of nanomaterials.

Nanomaterials are naturally occurring. For example, nanomaterials constitute the structure of the eyes of insects. Similarly, they can be artificial and human-made with engineered nanostructures. Naturally occurring nanomaterials have inspired many of the engineered ones. Important to realize is the ability to create these structures possesses immense potential. It enables advancing new technology for a variety of everyday objects. On the other hand, the rise in production necessitates the creation of restrictions and regulations to limit harmful damage.

Hazards and Risks - Nanotechnologies in Medicine

Nanotechnology leads the way to an innovative medicine called nanomedicine. Nanotechnology in medicine enables medical treatments using, for example, nanoelectronic biosensors. Biological devices were inconceivable only a few decades ago.
However, the various benefits of nanotechnology in medical treatments do not come without risks and dangers. Indeed, these medical applications can bring ecological and moral concerns. This relatively new science has not had the necessary time yet to be sufficiently researched and understood of all its consequences. Questions such as:

  • How do the nanoparticles injected into our body that treats certain diseases affect our biology in the long term?
  • How do these particles react in different environments than their intended ones?
  • How much testing is done to ensure that the nanomaterial does not have adverse reactions?

Notably, one harmful consequence to this technology is already occurring with carbon nanotubes applications. Indeed, carbon nanotubes are increasingly present in device modeling, automotive parts, and energy storage. Despite astonishing benefits, researchers have discovered that carbon nanotubes resemble asbestos fibers. As a result, they can cause various lung diseases and cancers found in animal testing.

Ref. Assessment of the Carcinogenicity of Carbon Nanotubes in the Respiratory System. Marcella Barbarino1,2,* and Antonio Giordano1,2. Daniel L. Pouliquen, Academic Editor, and Joanna Kopecka, Academic Editor. Cancers (Basel). 2021 Mar; 13(6): 1318. Published online 2021 Mar 15. DOI: 10.3390/cancers13061318

Nanotechnologies Engineering and Regulations

In the presence of potential risks, various jurisdictions are publishing regulations to minimize the damages nanotechnologies could cause to our health and the environment. Presently, worldwide organizations are also in the process of creating specific standards on nanomaterials.
Nevertheless, many consider that nanomaterials fall under the same conditions as chemicals and mixtures.

Nanomaterial Regulations in the European Union

The EU is the leader worldwide in regulating these nanoforms. Currently, they have the most specific regulations.

Nanomaterials under EU REACH and CLP Regulations

European Union Product Environmental Compliance

Thus, according to the European Commission and EUON (European Union Observatory for Nanomaterials), the EU REACH regulation about Registration, Evaluation, Authorization, and restriction of Chemicals also applies to nanomaterials.

Additionally, nanomaterials need to be packaged and labeled adequately. This regulation falls under the Classification, Labelling, and Packaging Regulation (CLP).

The Europan Chemicals Agency (ECHA) oversees both REACH and CLP regulations. As a result, ECHA monitors nanomaterials in different products, such as electronics, pharmaceuticals, cosmetics, etc.

Nanomaterials in Biocidal Products and BPR

Some nanomaterials serve as biocides. Accordingly, the EU Biocidal Products Regulation (BPR) targets nanotechnologies with monitoring and reporting requirements under certain conditions.

Some of the Important EU Nanotechnologies Requirements

Below, you can find examples of articles applicable to nanomaterials:

Regulation ReferenceDescription
BPR Regulation528/2012
  • Article 3(z) – definition of nanomaterial
  • Article 19 – Conditions for granting an authorization
  • Article 58 – Placing on the market of treated articles, with the name of all nanomaterials contained in the biocidal products, followed by the word ‘nano’ in brackets.
  • Article 69 – Classification, packaging, and labeling of biocidal products, with the nanomaterials contained in the product, if any, and any specific related risks, and, following each reference to nanomaterials, the word ‘nano’ in brackets.
CLP Regulation1272/2008
  • Annex I – Classification and labeling requirements for hazardous substances and mixtures
  • Annex II – Special rules for labeling and packaging of certain substances and mixtures
  • Annex V – Hazard pictograms
  • Annex VI – Harmonized classification and labeling for certain hazardous substances
  • Annex VIII – Harmonized information relating to emergency health response and preventative measures
REACH Regulation No 1907/2006
  • Annex I – General provisions for assessing substances and preparing chemical safety reports
  • Annexes III and VII to XI – Criteria and standard information requestions for substances placed on the EU Market, in quantities of 1 tonne or more per year
  • Annex VI and article 10 – Information requirements to be submitted for general registration purposes
  • Annex XII – General provisions for downstream users to assess substances and prepare chemical safety reports

Regulations of Nanotehncologies in the United States

United States Flag

The USA assumes nanomaterials regulations under the same regulations as other substances and chemicals. The federal Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) are responsible for implementing requirements on nanotechnology products. 

Most importantly, under EPA, the Toxic Substances Control Act (TSCA) requires the following:

  1. Manufacturers and importers of some nanomaterials must notify EPA and give details such as their name, volume, use, and hazard.
  2. Additionally, manufacturers of new nanomaterials must communicate information to determine and prevent potential risks to human health and the environment. 

Regulations of Nanotehncologies in Canada

Canada Enviropass

At the federal level, Health Canada and Environment Canada both regulate nanomaterials. Interestingly, Canada manages nanomaterials the same as any other substance via risk assessment and management. 

Specifically, if a nanomaterial is not present on the Canadian Domestic Substance List (DSL), the manufacturer or the importer of that substance must notify Environment Canada and provide further details. The Canadian Environmental Protection Act (CEPA) is the paramount federal environmental regulation of new substances.

Regulations of Nanotehncologies in China

China RoHS Flag

China is a leading investor in nanotechnologies. Strategically, standards address nanotechnologies in China. Here are some of them:

  • GB/T 13221 – Determination of particle size distribution           
  • GB/T 22458 – General rules of instrumented nanoindentation test  
  • GB/T 33827 – Determination of magnetic impurities in anode nanomaterials for Li-ion battery
  • GB/T 37664.1 – Nanomanufacturing—Key control characteristics—Luminescent nanomaterials
  • GB/Z 39262 – Nanotechnologies—Guidance on toxicological screening methods for nanomaterials  

International Standards for Nanotechnologies

ISO 14001 Symbol

Lastly, various international organizations have published standards to harmonize practices around nanotechnologies. For example, these standards are:

  • ASTM E2996 – Standard Guide for Workforce Education in Nanotechnology Health and Safety
  • ISO 12901 – Nanotechnologies – Occupational risk management applied to engineered nanomaterials
  • ISO 80004 – Nanotechnologies – Vocabulary

Benefits of Nanostructures

Despite hazards, these nanomaterials create opportunities to assist in various domains. Healthcare issues often themselves microscopic require microscopic solutions. Thus the need for nanotechnology. 

Creating nanostructures requires rearranging the molecules at the atomic level. As a result of this restructuring, the properties of the material are modifiable, such as :

  • greater strength
  • increased conductivity
  • improved reactivity

Interestingly, despite being minuscule, the overall surface can be extensive.

As a result, the more surface contact between two materials, the faster and more efficient the reactions can occur.

Therefore, it is possible to cover larger surfaces with the same material amount.

carbon nano tubes

Currently Implemented Nanotechnologies in our Everyday Lives

Undoubtedly, nanomaterials and nanotechnologies are already everywhere. Here is a list of a few sectors where nanotechnology is already present:

  • Electronics and computers
  • Automotive industry
  • Nanorobotics
  • Sports equipment
  • Biocides and agricultural applications
  • Medicine
  • Even skincare

Undoubtedly, nanomaterials and nanotechnologies are already everywhere. Here is a list of a few sectors where nanotechnology is already present:

Example Description
OLED (Organic Light-emitting diode) Screens Made of “thin flexible sheets of an organic electroluminescent material” (Oxford Languages).
Water repellent clothing Silica nanoparticles are weaved into the apparel’s fabric or sprayed onto it.
Stronger adhesives Unlike conventional glues, nano adhesive can be more adhesive when the temperature increases.
Flame retardants on furniture A carbon nanofiber coating reduces the furniture’s flammability.

Potential of Nanotechnologies

Despite all the readily available nanotechnology present today, the most exciting part is what is to come.

Improvements in Electronics

Nanoelectronics is a growing specialization of electronic engineering. Undoubtedly, nanoelectronics holds immense potential for future developments. Thus, longer-lasting, higher quality, lighter electronic components with nanomaterials are currently progressing. For instance, nanoelectronics can be:

  • Nanobatteries can be significantly smaller and lighter than regular ones. Nanobatteries can also have a much longer life. 
  • Circuit boards with nanolayers of conductive materials.
  • Nanodisplays with carbon nanotubes.
  • Nanoscale integrated circuits chips with self-aligning nanostructures. 

Medical Nano-Applications

Finally, advanced research is also being done, especially in the medical domain, to implement this science to better heal patients in a personalized and efficient way. We can expect to see improved drug delivery methods that target specific sick cells without the negative side effect of attacking healthy cells. Treatments for chronic diseases like heart disease and diabetes can become more refined. Cancer treatments can also improve. 

In conclusion, regulations like REACH, TSCA, or BPR already apply to traditional substances and nanomaterials. Nevertheless, specific legislations will likely increasingly control nanotechnology risks.

Questions about regulations of nanotechnologies and other applications? Contact the Enviropass team.