There are currently more than 5,000 products on the market containing NMs. In terms of industrial production, there are NMs known for their application and presence in the market, such as: silver AgNPs, alumina (Al2O3), iron oxides (Fe2O3 and Fe3O4), silica (SiO2), titanium (TiO2) or zinc (ZnO), nanoclays and nanocellulose. Table 1 shows some of the most representative NMs (Table 1):

Table 1. Main NMs and applications

Its applications in the packaging sector are of special interest —representing up to 20% of nanotechnological applications (Global Market Insights, 2018)— and allow to obtain intelligent packaging materials, which are active against pathogens or have greater durability thanks to the incorporation of nanoclays or graphene.

Expected growth in nanotechnology applications, with a current global market value estimated at 2 billion euros (CDTI, 2018), has been hampered in recent years by a combination of 4 fundamental aspects, including the need to guarantee the functionality of NMs in finished products, the high costs of NMs on the market, the uncertainty regarding the potential harmful effects of NMs on human health and the environment, and the emergence of approval procedures in the EU regulatory framework.

To deal with this situation, key factors such as the commitment of the European industrial policy to accelerate the processes of exploitation of nanotechnology for industrial growth and employment, the publication of new scientific data on the effects of NMs on health, and the emergence of new methodologies and techniques to improve production and risk management, allow us to estimate an encouraging future for nanotechnology, with an annual growth rate (CASG) of over 20% for the next 4 years (according to the consultancy Mordor Intelligence) and the definition of applications that will contribute extraordinarily to the development of new products to address the major challenges facing industry and society in the upcoming years.

Challenges of Nanotechnology

Regulatory aspects

The European regulatory framework establishes a set of provisions directly applicable to NMs, including approval, risk assessment and labelling requirements, such as regulations on cosmetic products, biocides, new foods or medical devices based on NMs, and "nano-specific" information requirements, highlighting  the entry into force of the amendments to Regulation (EC) No 1907/2006 REACH established by Regulation (EU) 2018/1881 for substances manufactured as nanomaterials, better known as "nanoforms" last  1 January 2020. In this regard, companies manufacturing nanoforms must:

• Incorporate information regarding the particle size, shape and surface properties of a nanoform in the registration dossier.
• Measure stability in test media and determine the dissolution rate in water.
• Report on the dustiness potential for an efficient evaluation of potential exposure.
• Replace the oral toxicity study by an inhalation study.

In addition, it is foreseen the next amendment of Annex II to REACH on Safety Data Sheets to reflect information specific to nanoforms and to ensure consistency with the ongoing work under the Globally Harmonised System of Classification and Labelling of Chemicals (GHS). The regulatory aspects discussed above pose a new challenge for industry in 2020, with the need to adapt their registration reports or to develop new ones considering nano-specific requirements. In the case of packaging materials, the use of the NMs is subject to approval by the competent food safety authorities (EFSA or FDA).

Safety and health at work

Concerning health and safety, the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) accepted the existence of proven health risks linked to several NMs, including but not limited to inflammation, tissue damage, fibrosis and tumor generation.

The main challenges for the industry lie in the lack of testing protocols and technical guidelines for the (eco)toxicological characterisation of particulate and insoluble substances —such as NMs— and the limitation of available technological measures to characterise workplace exposure levels.

As an added difficulty, no applicable occupational exposure limits (OELs) have been adopted so far given the multitude of shapes, sizes, aspect ratios and physicochemical properties found for the same chemical composition in the case of NMs.

The situation is further aggravated by the lack of studies on the effectiveness of containment, ventilation and personal protective equipment (PPE) systems, considering that the test criteria defined by international standards are based on particle sizes far from the average diameters (Ø 40 - 65 nm) of materials such as silicon oxide, titanium oxide, zinc oxide, cerium oxide or aluminum oxide.

The above-mentioned aspects are a challenge for the industry, which must ensure a high level of protection of the environment and human health.

Production and integration of the value chain

Taking into account the value chain of the nanotechnology sector, the main challenges essentially lie in the following elements:

• Obtaining reproducible and well characterized NMs.
• Managing the application of chemical and physical modification techniques to develop functional NMs and to guarantee its compatibility in the target matrix.
• Increasing the production capacity (scaling).
• Commercialising them at competitive prices, guaranteeing the quality and safety of the NMs.
• Improving nanosafety related aspects.
• Developing aspects related to recycling and migration of NMs in composites.
• Diversifying properties and applications.

On the basis of the points listed above, the development of nanotechnology requires a significant effort from the industry for the development of efficient and safe production means that allow the industrial implementation of the nanotechnology.

Nanotechnology Opportunities

Health and Safety

As a result of the commitment in the European Union research and innovation programmes to the concept of "safe by design (SbD)" or "safety by design", significant progress has been made in the safety of NMs, based mainly on the development of non-toxic NMs that are safe for the worker, the end user and the environment.

There are already numerous examples in the literature on BDS, highlighting the modification of the surface of MLs to alter the release of toxic ions or the variation of the form to reduce pro-inflammatory activity (Park, E.J et al., 2015; Chung et al., 2017).  Table 2 presents an integrated view of the published safe design strategies: 

Table 2. Current examples of BDS with NMs (Source: A. Kraegeloh, 2018).

With regard to exposure control, there has been a considerable increase in equipment that allows the assessment of exposure levels in the workplace, with new portable and robust equipment that allows for obtaining information on the quantity of particles or their average diameter with a time resolution of 1 second. Examples of equipment costing less than 8,000 euros are the DISCmini (Testo), the Partector II (Naneos) or the NanoWatcher (Controlnano) –developed by technical staff at ITENE—, the latter being notable for its control interface aimed at risk assessment by prevention technicians and the integration of a sampling pump (Fig.2).

Other aspects that promote the safety of products and processes are the existence of software tools that are increasingly accurate in estimating exposure (NanoDESK, NanoSafer), databases with greater references (eNanomapper), or platforms which support the decision-making process in risk assessment (caLIBRAte). We highlight the integrated vision of the NanoDESK platform (http://sudoenanodesk.net), developed by ITENE with the support of ERDF funds, which allows the identification of NMs for a specific function or application, the assessment of the hazard or the estimation of exposure.

Innovation and added value of nanotechnology

Nanotechnology is key to achieving the sustainable development goals set out in Agenda 2030 and addressing society's demands for transport, health, energy, raw materials and smart cities. The state strategic action of Nanoscience and Nanotechnology also includes 7 thematic areas or lines where NMs can help to improve the competitiveness, sustainability and growth of our business fabric, highlighting the field of materials, in which packaging applications are included.

From 2010 onwards, an increase in nanotechnology applications and markets has been observed, which together with the EU's industrial policy means that by 2025, Nanotechnology will be consolidated in key sectors such as electronics, packaging, construction, cosmetics and medicine, providing benefits for consumers.

In this context of growth, estimated to be above 20% in most studies —22% in the case of packaging (Global Market Insights, 2018)— investment in nanotechnology is key to industrial technology development, highlighting the proximity of nanotechnology products to the market.

By way of conclusion, the new era marked by the beginning of 2020 will have nanotechnology as a protagonist, including an improvement in productivity and the management of potential risks for NMs.

More information at https://www.itene.com/en/