Environmental, health and safety and regulatory considerations of nanomaterials

Author: Dominik Jasinski, Particula Group

Nanotechnologies and nanomaterials have created a high interest in recent years due to their unusual mechanical, electrical, optical and magnetic properties and a wide range of potential usages that could produce advancements in medical treatment, pharmaceutical technologies, food transportation and electronics. However, as their production and utilization proceed to develop, so do worries about its effect on people (e.g. health and safety threat to exposed workers and consumers) and the environment. Once enter into human body (either through the skin, gastro-intestinal track or lung), nanomaterials can cause inflammation, expanded susceptibility to infectious diseases, or even to immune system diseases or cancer. Furthermore, nanoparticles have demonstrated to be toxic to other living beings and biological systems once discharged into the environment (air, and water). There are also potential safety hazards involving nanomaterials, such as fire, explosion and other unanticipated reactions.  Hence, the mass application of nanomaterials requires the management of health, safety and environmental aspects during their production, manipulation, storage, incorporation, use and disposal.

Nanotechnologies and regulations

Up until this point, neither engineered nanoparticles nor the materials that contain them are exposed to any extraordinary regulations in Europe, although the Framework Directive 89/391/EEC [1], the Chemical Agent Directive 98/24/EC [2], and the Carcinogen and Mutagen Directive 2004/37/EC [3] on worker protection also apply to nanomaterials. Furthermore, nanomaterials are covered by the same rigorous regulatory framework that ensures the safe use of all chemicals and mixtures, e.g. the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) [4] and Classification, Labelling and Packaging (CLP) regulations [5]. In addition to REACH and CLP, there is also sector-specific legislation in the EU for specific groups of products. They cover, for example, biocides, plant protection products, cosmetics, pharmaceuticals, toys, food, and electronic goods. Hence, despite our incomplete knowledge on the peculiarities of testing and assessing health and environmental effects of nanomaterials, the existing legislation enforce that the hazardous properties of nanoforms of substances have to be assessed and their safe use needs to be ensured with respect to production, handling of or labelling.

Responsible development in BIONANOPOLYS

Our philosophy in BIONANOPOLYS project is that the responsible development of nanomaterials and nanoproducts has to result in their safe as well as functional production, use, and disposal at the end-of-life cycle. The Open Innovation Test Bed (OITB) that is being established in the project aims to assure and promote the responsible and safe use of nanomaterials along the entire value chain of industrial innovation processes, from occupational and environmental exposure to consumer safety and regulation aspects and end-of-life disposal. The OITB offers a range of safety and environmental assessment services, such as: (1) hazard profiling (human and environmental); (2) occupational exposure assessment studies; (3) environmental release estimations and assessment along the value chain; (4) definition and validation of proven risk management measures to control the exposure and reduce release of nanomaterials to the environment, (5) regulatory assessment and development of safety protocols for specific product applications (e.g. food and cosmetics); (6) end-of-life assessment to ensure recyclability, compostability and biodegradability of the manufactured nano-based materials and products.

OITB services for a holistic approach

The OITB services represent a new proactive approach to improve both safety and efficacy of nanotechnology based on pre-regulatory safety and environmental assessment. Anyone that comprehend the importance of safety of nanomaterials can benefit from these services and thus contribute to the successful promotion of nanotechnology in their new applications. In the absence of nano-safety harmonized standards to satisfy the mandatory environmental, health and safety requirements, the OITB services can assist in taking ideas from nanotechnology research and proof of concept to production scale by anticipating the exposure potential, sampling and evaluating emissions and exposure, recommending control mechanisms and establishing an effective environmental, health and safety programs. They can also help in maintaining a long-term sustainable growth by reducing injury and illness and improving overall employee well-being and staying abreast of changing legal requirements and practice advancements in nanotechnology.

[1] https://osha.europa.eu/en/legislation/directives/the-osh-framework-directive/1

[2] https://osha.europa.eu/en/legislation/directives/exposure-to-chemical-agents-and-chemical-safety

[3] https://osha.europa.eu/en/legislation/directive/directive-200437ec-carcinogens-or-mutagens-work

[4] https://echa.europa.eu/regulations/reach/legislation

[5] https://echa.europa.eu/regulations/clp/legislation