In manufacturing, as in most areas of life, safety is paramount. Not only from the perspective of providing safe products for consumers, but also in creating low risk working environments where worker health is placed above profit.
Nowhere is this more hotly debated in the current trend of new raw materials supply chains than in the production of nanomaterials.
However, while some may argue that the risks imposed by nanomaterials are nanosized, the dangers are certainly real and present.
“Although human and nonhuman species have been exposed to naturally occurring nanoparticles throughout geological time,” argues a report published in the American Medical Association’s Journal of Ethics, “there is some concern that ENMs could pose greater risks than naturally occurring nanoparticles because organisms have not had sufficient time to adapt to their unique properties. Also, some types of ENMs might persist in the environment longer than naturally occurring nanoparticles.”
There are also immediate threats from the presence of nanomaterials. As the report a outlines, “Factory workers might inhale carbon nanotubes during manufacturing, and consumers might inhale them when handling materials, such as tennis rackets or frying pans, which have been coated with these materials. Other ENMs [engineered nanomaterials], including titanium dioxide and nickel, can induce immune responses. Nanosilver can cause oxidative stress and can have toxic effects on marine species if it enters aquatic environments. Overuse of nanosilver, especially in non-medical applications, could lead to the development of antibiotic resistance.”
Given these risks, what safeguards should governments put in place to keep people and the environment out of harm’s way.
In Europe, one of the pillars of legislation which ensures safe manufacturing and production is REACH; a central organisation of every chemical product imported, exported, produced, and sold in the European Union.
While REACH originally had its disbelievers, today it is seen as a backstop of safety that ensures chemical industry standards are maintained, chemical products are used appropriately, and that chemical manufacturers, suppliers, and purchasers are all reading from the same playbook.
REACH has been so well received that other regions are now creating their own all-inclusive chemical product registers, K-REACH in Korea, J-REACH in Japan, as well as chemical registers that are being founded in Turkey and the USA. All of which follow (to a lesser or greater extent) the European model.
Alongside international expansion, REACH is now being extended to include the nanomaterial sector. Unfortunately, the nanotechnology industry has not responded to calls for registering nanomaterials as eagerly as had been hoped.
As the EU Commission reported in February 2020, “ECHA [the European Chemicals Agency] has so far received a low number of registration dossiers for nanomaterials. By 1 January 2020, only 36 substances covering nanoforms have been registered according to the updated REACH requirements – 10 % of what the Agency expected.”
While 36 may sound like an extraordinarily low response rate when compared to the 21,000 chemical products listed, the number is reflective of the young age of the nanotechnology industry. The report adding that, “ECHA has received 95 unique submissions for 36 substances covering nanoforms according to the updated REACH requirements. The Agency expected to receive updated registrations for approximately 300 substances, based on data from the Belgian and French national inventories and the European Commission’s catalogue of nanomaterials used in cosmetic products.”
In response, the agency is “working closely with key industry associations and Member States to better understand the additional actions needed”. For example, it has expanded its support and education process, updated manuals and guidance for registration, produced several webinars to better explain the process, and has highlighted the legal obligations and potential penalties on nanomaterial producers that fail to comply.
However, fears still remain that the process for registering nanomaterials is still insufficiently smooth. As a report published by the manufacturing Yordas Group explains, the registering of nanomaterials into the system has not been smooth. The article stating that, “Although ECHA has been providing some support with new guidance documents and webinars, many registrants have found it difficult to understand and interpret their obligations. Multiple reasons, including confidentiality issues within the SIEF [Substance Information Exchange Forum], the lack of validated test methods or difficulties with the characterisation of the nanoforms have been mentioned as playing a role in the low number of received registration dossiers and half of these submissions failing the completeness check.”
This is unfortunate, as the process of registering nanomaterials was designed to be a straight-forward as possible.
To find out how the nanotechnology industry failed its first transparency test, read: In the Spotlight: Nanomaterial Safety and Transparency Part Two