Nanomaterials are structures at the nanometre-scale (a nanometre is 10 power of -9 of one metre), a scale, comparable to that of atoms and molecules.
Evidence shows that the same substance behaves differently at nanoscale compared to its larger-scale counterpart. This allows the development of light-weight materials with high strength, high conductivity or high chemical reactivity. Nanotechnologies are often viewed as one of the critical technologies of the 21st Century, and have been identified by the European Commission is seen as one of six Key Enabling Technologies (KETs) which are expected to act as significant drivers of innovation, technological and economic competitiveness, and societal developments in Europe over the next few decades. As such, nanotechnologies have received significant investment for innovation under the EU Horizon 2020 Work Programme.
While nanomaterials offer numerous benefits, concern about their potential hazards to human health and the environment has grown over the past years.
The term nanoparticles is used for constituent particles of nanomaterials or for nanoscale particles generated by different sources.
Sources of nanoparticles can be natural (like volcano emissions) or anthropogenic: unintentional (like diesel particles) or engineered (intentionally produced with specific properties). This article focuses on engineered nanoparticles and manufactured nanomaterials.
The European Agency for Safety and Health at Work (EU-OSHA) web site provides detailed information on nanomaterials including reports, factsheets, case studies, legal aspects, risk management and good practice examples. 
Definitions and categorisation
Several international and European organisations have developed or proposed definitions of the term ‘nanomaterial’.
On 18 October 2011, the European Commission adopted a Recommendation on the definition of the term 'nanomaterial', mainly based on considerations on a definition of nanomaterial for regulatory purposes by its Joint Research Centre and on the second opinion adopted by the EU Scientific Committee on Newly and Identified Health Risks. According to this Recommendation, a 'nanomaterial' means:
- 'a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm - 100 nm.
- In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50% may be replaced by a threshold between 1 and 50%.
- By derogation from the above, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.'
The number size distribution is expressed as number of objects within a given size range divided by the number of objects in total.
The scope of the Recommendation by the Commission covers nanomaterials when they are substances or mixtures, but not when they are final products. This means that if a nanomaterial is used amongst other ingredients in a formulation the entire product will not become a nanomaterial. This is in line with the definitions proposed by the Organisation for Economic Co-operation and Development (OECD) and the International Organization for Standardization (ISO).
This definition is meant to be used as a reference for determining whether a material should be considered as a ‘nanomaterial’ for legislative and policy purposes in the European Union. The definition is currently used in the EU regulations on biocides and medical devices. It also serves as a reference in the amendment of the older nanomaterial definitions in the cosmetics and food information regulations. Given the fast pace of technological development and scientific progress in the nanotechnology field, it was envisaged that the scope of the European recommendation on the definition of a nanomaterial would be reviewed, in particular with regard to whether the number size distribution threshold of 50 % should be increased or decreased.
Extensive review reports have since been published by the European Commission’s Joint Research Centre (JRC), concerning:
- Compilation of information concerning experience with the definition (EUR 26567 EN);
- Assessment of collected information concerning the experience with the definition (EUR 26744 EN);
- Scientific-technical considerations to clarify the definition and to facilitate its implementation (EUR 27240 EN).
Following a stakeholder consultation of the draft findings toward the end of 2015, the Commission is expected to conclude the review in 2016, with adoption of the recommendation expected in 2017.
The Working Party on Manufactured Nanomaterials (WPMN) under the OECD Joint Chemicals Programme applies the following definitions:
- Nanomaterial: material which is either a nano-object or is nanostructured;
- Nano-object: material confined in one, two or three dimensions at the nanoscale;
- Nanostructure: having an internal or surface structure at the nanoscale.
The European Committee for Standardization (CEN) and the International Organization for Standardization (ISO) co-operate in elaborating standards for terminology and definitions for nanomaterials. The ISO series ‘Nanotechnologies – Vocabulary’(ISO/TS 80004), published with the intention of standardising and facilitating communication on nanotechnologies, lists terms and definitions related to the field of nanotechnologies. Key terms and definitions in this series are summarised in Table 1.
|nano-enabled||exhibiting function or performance only possible with nanotechnology||ISO/TS 80004-1:2015|
|nanofibre||nano-object with two external dimensions in the nanoscale and the third dimension significantly larger||ISO/TS 80004-2:2015|
|nanomaterial||material with any external dimension in the nanoscale or having internal structure or surface structure in the nanoscale||ISO/TS 80004-1:2015|
|nano-object||discrete piece of material with one, two or three external dimensions in the nanoscale||ISO/TS 80004-1:2015|
|nanoparticle||nano-object with all three external dimensions in the nanoscale||ISO/TS 80004-3:2010|
|nanoplate||nano-object with one external dimension in the nanoscale and the two other external dimensions significantly larger||ISO/TS 80004-4:2011|
|nanoscale||length range approximately from 1 nm to 100 nm||ISO/TS 80004-1:2015|
|nanostructure||composition of inter-related constituent parts in which one or more of those parts is a nanoscale region||ISO/TS 80004-1:2015|
|nanostructured material||material having internal nanostructure or surface nanostructure||ISO/TS 80004-1:2015|
|nanotube||hollow nanofibre||ISO/TS 80004-3:2010|
|nanowire||electrically conducting or semi-conducting nanofibre||ISO/TS 80004-2:2015|
In the absence of an internationally agreed official terminology, the way different types of nanomaterials are referred to may differ from one document to another. For example, in the case of fullerenes some authors use this term regardless of their shape: round (spherical like 'buckyballs' or multiple-walled ellipsoids like 'buckyonions') or tubular, while others refer to the latter as carbon nanotubes. Several criteria have been proposed to define different categories of nanomaterials, based for example on material composition (organic/inorganic), the source of nanomaterials (natural/unintended/engineered), their properties (insoluble/soluble), etc.
The unique properties of nanomaterials have led to their use in many applications in industrial and non-industrial sectors like aerospace, construction, energy, textile, automotive industry, transport and medical technology. A few examples of applications are presented in Table 2
|Electronics, ICT and photonics||Carbon nanotubes, fullerenes, graphene|
|Pharmaceuticals and medicine||Nanomedicines and carriers (nanobiotechnology)|
|Cosmetics and personal care||Titanium dioxide, zinc oxide, fullerenes, gold|
|Catalysts and lubricants||Cerium oxide, platinum, molybdenum trioxide|
|Paints and coatings||Titanium dioxide, gold, quantum dots|
|Environmental and water remediation||Iron, polyurethane, carbon nanotubes, graphene|
|Agrochemicals||Silica as carrier|
|Food packaging||Gold, nanoclays, titanium dioxide, silver|
|Composite materials||Graphene, carbon nanotubes|
Source: Adapted from Senjen 
The Project on Emerging Nanotechnologies’ (PEN) international on-line inventory of nanotechnology-based consumer products and its associated ‘FindNano’ iPhone application contains, as of November 2016, over 1800 products or product lines. This "living" inventory is intended as a resource for consumers, citizens, policymakers, and others who are interested in learning about how nanotechnology is entering the marketplace. A number of other consumer product databases have also started to emerge, such as the ‘Nanodatabase’ developed by the Danish Authorities. However, all of these databases identify products which are claimed to be "nano" by the manufacturers or the retailers of the products, and no independent validation of the “nano"-claim has been made.
Some materials, as shown in Table 3, are well known as nanomaterials (like carbon black), others, like fullerenes or nanotubes, are newer discoveries. Fullerenes are cage-like structures made of pentagonal and hexagonal carbon rings. Fullerenes have been studied for applications in catalysis, pharmaceuticals and molecular sieves. Carbon nanotubes have two dimensions at nanoscale and can be single-walled (SWCNT) or multi-walled (MWCNT). Carbon nanotubes have a quite large variety of applications in electronics, medical sector, as lightweight composite materials, in textiles etc.
|Aluminium oxide||Dysprosium oxide||Polyethylene|
|Antimony oxide||Germanium oxide||Praseodymium oxide|
|Barium carbonate||Indium oxide||Samarium oxide|
|Boron oxide||Iron oxide||Silicon dioxide|
|Calcium oxide||Lanthanum oxide||Silver|
|Carbon black||Lithium titanate||Single and multi-walled carbon nanotubes|
|Cerium oxide||Manganese oxide||Tantalum|
|Cluster diamonds||Molybdenum oxide||Terbium oxide|
|Cobalt oxide||Neodymium oxide||Tungsten|
|Colloidal gold||Nickel||Yttrium oxide|
|Copper(II) oxide||Niobium||Zinc oxide|
Source: Adapted from: JRC
The risk to human health as a result of exposure to a chemical is generally considered to be a function of the intrinsic harmfulness of the chemical (its toxicity) and the dose (amount) which accumulates in a specific biological compartment (e.g. the lungs). For occupational exposures, it is often very difficult to determine the dose directly, particularly in the case of insoluble particulates. Therefore, in order to measure and manage the risks, it is usual to assess exposure as a surrogate for dose.
In most countries, legislation related to the use of chemicals or other hazardous substances in the workplace requires employers to undertake a risk assessment to identify and manage exposure to hazardous substances in order to prevent ill health of both employees and others who could be exposed. This is discussed in more detail as part of the ‘Dangerous Substances’ article.
Several frameworks have been suggested for assessing and managing risks from particulate nanomaterials, all of which are based on a common risk assessment approach. The International Organization for Standardization (ISO) has proposed a step-by-step approach for nanomaterial risk evaluation and management which can be summarised follows:
- Describe materials and applications: identify and describe the nanomaterials being evaluated and their intended uses or functions (including potential benefits); where required, identify analogous materials that might help address data gaps;
- Develop material profiles: develop sets of “profiles" including the nanomaterial's physico-chemical properties, inherent environmental, health and safety hazards, and potential human and environmental exposures throughout the nanomaterial's lifecycle;
- Evaluate risks: information from the profiles should be evaluated to identify and characterise the nature and magnitude of the risks (i.e. combination of hazards and exposure) presented by particular nanomaterials and their anticipated applications;
- Assess risk management options: Evaluate how to manage the risks identified in Step 3 and recommend a course of action; options might include product or process modifications, engineering controls, protective equipment, and/or risk communication;
- Decide, document and act: appropriate to the product’s stage of development, decide whether or in what capacity to continue development and production of the nanomaterial (or the process or product using the nanomaterial); document decisions and their rationale and share information with relevant stakeholders as appropriate;
- Review and adapt: Through regularly scheduled reviews, it might be necessary to update the risk evaluation, ensure that risk management systems are working as expected, and revise systems in response to new information or conditions.
Undertaking a thorough risk evaluation typically relies on having:
- good information about the hazardous nature of materials;
- good information about the effectiveness of control approaches, and;
- convenient and accessible ways to monitor exposure.
One of the difficulties in applying this approach to nanomaterials is that available information may be incomplete or incorrect. Such knowledge gaps introduce significant uncertainty into any risk assessment. In general, the greater the gaps in knowledge, the more cautious the risk management strategy should be.
Hazard identification and realistic interpretation of dose-response relationships are critical steps in the process of risk evaluation and management. In 2004, the Royal Society and the Royal Academy of Engineering published a major review of the opportunities and uncertainties of nanotechnologies. This was one of the first reports to highlight the potential risks to health and the environment that may arise from exposure to nanomaterials. Following significant research in this area, there is now a substantial and ever growing body of toxicological evidence indicating considerable differences in hazard between nanomaterials and their bulk counterparts, and also between different types of nanoparticles.
Plausible toxicology issues for nanomaterials, which should be kept in mind when handling and using nanomaterials, include:
- Reactivity. Surface charge may play a significant role during cellular uptake and biological interactions. Nanomaterials possessing a significant proportion of reactive metals (e.g. residual catalyst from the manufacturing process) may possess hazardous properties. In addition, photocatalytic nanomaterials may cause inflammation, oxidative damage, and genetic damage.
- Solubility. Some types of nanoparticles become more soluble as particle size decreases. This could imply increased bioavailability of ions from particles previously considered to be insoluble.
- Morphology. Based on toxicological research on asbestos and other industrial fibres, the ‘fibre paradigm’ states that fibres which are bio-persistent in the lungs and longer than 15 - 20 µm with a diameter less than 3 µm are considered to be hazardous to human health. Some high aspect ratio particulate nanomaterials (HARNs) (e.g. some carbon nanotubes, nanowires, nanoplatelets, etc.) meet this description and are therefore likely to persist in the lungs, if inhaled.
- Specific surface area. One of the main reasons nanomaterials tend to be more reactive than their corresponding larger-scale equivalents is that, per unit mass, they have a much higher surface area.
- Translocation potential. As a result of their small size, nanoparticles and other nano-objects can reach parts of biological systems which are not normally accessible by other larger particles.
When looking holistically across the current toxicological evidence base across a wide range of nanoparticle types, the UK NanoSafety Group considers that, in general:
- many nanoparticles are likely to post a low hazard at plausible exposures to the lungs;
- skin is unlikely to be affected by the common nanoparticle types. For example, the European Commission’s Scientific Committee on Consumer Safety (SCCS) has concluded that the use of ZnO and TiO2 at a concentration of up to 25% as a UV-filter in sunscreens can be considered not to post any risk of adverse effects in humans after dermal application.
However, as noted by the Group, it has been shown that some nanoparticle types, such as zinc oxide for example, might adversely affect the lungs at high and sustained levels of exposure. Long (>15 µm) nanofibres and nanotubes, low density “fluffy" nanotube bundles, and thin plate-like particles - all of which are large but with small aerodynamic diameters - might also pose unusual respiratory hazards.
It should be noted that the majority of studies undertaken to date employ non-validated in vitro test methods. Whilst providing valuable insights into the intrinsic toxicity of the nanomaterials being evaluated, the relationship between in vitro toxicological data and in vivoeffects is currently unclear. This means that in vitro studies form an unsuitable basis for risk assessment at the current time. To date, very few inhalation studies have been undertaken, which largely precludes the development of Occupational Exposure Limits (OELs) for nanoparticles.
The large specific surface area and reactivity of nanoparticles influence not only their toxicity but also safety hazards, as nanoparticles show a high potential for catalytic reactions, ignition or explosion. Their ability to get and remain airborne for a long time and their low minimal ignition energy raises the risk of explosion, including that induced by electrostatic charges that may occur when powders are manipulated.
Engineers of the German accident insurance company for the chemical industry and raw materials (BG RCI) showed that dusts at micro scale tend to explode more vehemently and the ignition sensitivity tends to increase the finer the particles become. The temperature of self-ignition also decreases when the particles are finer.
Studies have classified the explosion severity of different nanoparticles from weak (carbon black and carbon nanotubes) to very strong (aluminium), depending on particle nature, size and agglomeration. Aluminium powders have a minimum ignition energy that is low enough to be ignited with static energy.The severity of their explosion was classified as strong to very strong, depending on particle size. Tests showed that aluminium nanopowders were less explosive than micropowders, probably due to the oxide layer on nanoparticles. Moreover, the same study concluded that if a nanopowder agglomerates, it shows explosion severity of the same order as micropowder of the same substance. If flammable substances, like solvents, are adsorbed on the surface of the particles, the explosion is even more likely.
Sources of exposure
Increased production and use of nanomaterials leads to the potential for increased exposures to workers, consumers and the environment. Human exposure to engineered nanomaterials has the potential to occur during all stages of the nanomaterial life cycle, including during the production of nanomaterials and nano-enabled products, use (service life) of nano-enabled products, and end-of-life recycling, processing and disposal of nano-enabled products.
Occupational exposure to nanomaterials may occur particularly during the production stage if appropriate control measures are not in place. The small size of nanoparticles makes them easily airborne and favours their dispersion. Processes in which dry nanomaterial powders are generated, handled or used have the potential to to lead to significant occupational exposure. Blending, reloading, drying or vacuum cleaning are operations that may increase the level of exposure to airborne nanomaterials. The same applies for sprayed colloidal suspensions, whereby the hazards of the dispersant should also be considered.
Production phases are generally run under controlled conditions, in principle using closed-systems. It is therefore where worker exposure is the easiest to control. However, possible exposure when maintaining or cleaning the installation, or in the case of leakage or waste handling has to be considered and also properly controlled. Significant exposure may also occur when the nanomaterial is recovered from the installation and further processed. Measurements of airborne nanomaterials have shown higher levels for example where processes such as extrusion and cutting of bags containing nanomaterials. 
Whether exposure can occur when handling, processing or using nanomaterials embedded into a solid matrix or products containing nanomaterials is currently a subject of investigation. There is some evidence to suggest that particle release may occur during the machining of solid nanocomposites, most noticeably during dry surface grinding, dry cutting, or dry drilling, with the level of release being highly dependent on the material, its composition, how well the nanomaterial is bound in the polymer matrix, and the energy applied to the process. Performing the same tasks under wet conditions has been shown to be an effective method for reducing the number of airborne particles. However, the majority of these studies have been laboratory-based simulations, often in a worst-case scenario, and may not necessarily represent industrial conditions and working practices. As long as no clear conclusions can be drawn on this, the Precautionary Principle should apply in terms of the choice of prevention measures.
If information on the presence of nanomaterials is not available down the user chain – arising, for example, from Safety Data Sheets which lack information or use inappropriate data – employers and workers may not be aware that they handle products containing nanoparticles/nanomaterials. This could lead to inadvertent exposures since employers and workers do not have the necessary information to implement adequate protection and prevention measures.
Nanomaterials may enter the body primarily through inhalation, ingestion and through skin (dermal) contact.
As a result of their small size, nanoparticles and other nano-objects can reach parts of biological systems which are not normally accessible by larger particles.
The small size of nanoparticles allows for deep penetration into lungs, up to the alveoli or air sacs (ends of the respiratory tree). There is an increased possibility of nanoparticles crossing cell boundaries, or of passing directly from the lungs into the blood stream and so on to other organs in the body. This process is known as translocation and in general nanoparticles can translocate more easily than other larger particles although this is typically still to a small extent.
Ingestion may happen accidentally or as a result of breaking hygiene rules (e.g. eating with contaminated hands). Ingestion is also possible as a “secondary" effect of inhalation (swallowing of deposited material, cleared from the respiratory tract).
Penetration of nanoparticles through the skin has been a subject of much discussion, especially regarding the hazard associated with cosmetics and sunscreen protection. Following a comprehensive evaluation of the literature regarding the dermal absorption of nanomaterials, it was considered that that absorption of nanoparticles through the skin is possible, although it occurs to a very low degree, and that the level of penetration may be greater than for larger particles. However, there is need for more robust testing approaches before any firm conclusions can be drawn. A recent study focused specifically on sunscreen products, found that dermal penetration of titanium dioxide and zinc oxide nanoparticles did not occur at or above the limit of detection of the experimental methods used. These findings are in accordance with the conclusions that were made by the EU Scientific Committee on Consumer Safety (SCCS) which stated that both types of nanoparticles are safe to use for dermal applications up to a concentration of 25% in cosmetic products.
Occupational exposure monitoring
Assessment of exposure is a key element in relation to understanding the potential risks of nanomaterials. For most of the chemical agents, monitoring is performed by measuring their mass concentration in air, in the breathing zone of the worker. For fibres the measured parameter is the number of fibres in a given air volume. When legislation provides occupational exposure limits (OELs), monitoring results are compared to these limits and considered in the risk assessment.
For nanomaterials, assessment of the exposure of workers presents a number of significant challenges, including:[SR1]
- At the current time there is no clear advice that can be given as to the appropriate choice of metric. The mass of nanomaterials is typically so small that in many instances measurement of mass may be inaccurate and require a long sampling time. Additional relevant information about exposure to nanomaterials can be gained from number and surface area concentration measurements;
- Nanomaterials form highly aggregated clumped entities in the workplace environment and therefore the particles identified will often not be their primary particle size;
- Discrimination from background, both in instrumental and filter based sampling, may prove challenging during the measurement/assessment of nanomaterials in the workplace. Using a combination of filter and instrumental sampling before any activity is carried out, in addition to sampling carried out away from the process in parallel to near-field measurements helps to overcome this, although this may be problematic during high background environments;
- The persistence of process-related particles in the workplace environment is a challenge when identifying release of material during a process. The analysis of background filter samples and instrumental data can aid the interpretation of particle persistence of a particular material by identifying its presence before the activity in question.
- The measurement of High Aspect Ratio Nanomaterials (HARNs) (e.g. carbon nanotubes) can be particularly challenging due to their unique morphology and subsequent behaviour in the air. HARNs are detected by instrumentation and filter sampling by their aerodynamic size and not their physical size.
Whilst there is no consensus view on a single most appropriate metric, method or strategy for characterising releases or emissions of nanoparticles from processes and assessing the potential for exposure, it is widely accepted that a combination of instruments providing data on mass and number distributions as a function of particle size and time, can provide informed insight to presence of particles posing a risk to health and the effectiveness of methods of control. Monitoring should be done according to a strategy that will integrate aspects regarding emission sources, working processes and procedures, workplace design and conditions, possible aggregation of particles and measuring objectives. Background concentration of ultrafine particles should be measured and distinguished when reporting occupational exposure results.
Several standards have been published to support the identification and assessment of emissions of airborne manufactured nanomaterials in the workplace. A number of measurement strategies have also been proposed, most notably the Nanoparticle Emission Assessment Technique (NEAT). This strategy is based on the detection of airborne nanomaterials by using portable instruments measuring the number concentrations of the nanomaterials together with filters that allow offline analysis of the samples on the filters for particle morphology, size, count and elemental composition. Nevertheless, implementation of strategies such as NEAT continue to be a challenge. One of the reasons is that affordable easy-to-use and portable instruments have been largely unavailable. Significant work is on-going to develop novel measurement methods for airborne nanoparticles, including through recent projects such as NANODEVICE, NanoDetect, and NanoIndEx.
Further research into the hazards of engineered nanomaterials is required in combination with the continual reassessment of available data to determine whether specific health surveillance is warranted for workers who are producing or using particulate nanomaterials. Health surveillance specific for hazardous particulate nanomaterials is not considered to be practical at the current time due to a lack of information about anticipated health effects and suitable biomarkers.
In their guidelines for occupational risk management applied to engineered nanomaterials, ISO suggest that a prudent approach would be to collect at least some limited information about the materials being used and the duration of use. Such information will help to build up a profile of potential exposures which could be important if any health effects are observed at a later date.
Efficient health monitoring for workers exposed to nanomaterials requires the use of sound biomarkers of exposure and/or effects, with research currently on-going in this area . In any case, the health hazards related to the material, irrespective of the nanoscale form, should still be considered as part of the usual risk assessment. This should be informed by considering the likely routes of exposure for the material of concern.
Risks should be prioritised for action. Using the information from the hazard identification and exposure assessment, priorities and resources can be assigned to the management of these risks commensurate with the level of risk. Managing or controlling risks involves eliminating them so far as is reasonably practicable, or if that is not possible, minimising the risks so far as is reasonably practicable.Since the hazards of nanomaterials are still being investigated and are not yet totally known, the Precautionary Principle should be applied when it comes to choosing prevention measures and exposures should be reduced to “As Low As Reasonably Achievable" (ALARA); see the Communication from the Commission on the precautionary principle.  Smaller companies should seek external guidance from e.g. accident insurance associations or labour inspections.
The ALARA Principle should be used in the application of the ‘hierarchy of controls’ to reduce risks in the workplace. The basis for the hierarchy is to eliminate the hazard when possible (i.e. substitute with a less hazardous material) or, if not feasible, control the hazard at or as close to the source as possible.
Control measures should be applied for all workers that may be exposed to nanomaterials at work, whether during the main technological activities or during maintenance, cleaning, storage, or waste treatment. Numerous organisations have published best practice guidance for the safe handling and use of nanomaterials , including recommendations for adequate control measures to minimise worker exposure. In addition, a number of qualitative control banding approaches and tools have been developed where specific controls are recommended based on a determined level of risk for a particular process.
Hazard banding – where materials are classified into bands based on limited toxicological data and used to inform maximum exposure levels and control schemes - has been proposed as a means to support the risk assessment of nanomaterials in the absence of further data. A variety of approaches have been suggested, including the use of physicochemical or structural alerts, many of which are incorporated into control banding tools (see later). Alternatively, a default preliminary category associated with sufficient exposure control measures could be assigned that would protect workers should a material later be shown to be toxic. These approaches are still very much under development and yet to be validated for nanomaterials.
Elimination of hazardous substances, including hazardous nanomaterials, from processes and products is the measure that has to be given priority.
If elimination is not feasible, substitution by a non-hazardous or less hazardous substance, or by a different and safe technology should be considered. Whilst substitution or elimination of nanomaterials is often not feasible, it may be possible to change some aspects of the physical form of the nanomaterial or process in a way that reduces nanomaterial release, including the use of appropriate control measures.
It is widely accepted that enclosure and isolation of the process can minimise the airborne release of nanomaterials into the air during handling, production and use. All operations in which there is a deliberate release of nanomaterials into the air should be performed in contained installations, or where workers are otherwise isolated from the process. All other processes involving the use of dry nanomaterials should be performed in enclosed installations where possible. An enclosed system is particularly recommended for activities like measuring raw or manufactured materials, pouring (including mixing) into or collecting from the producing or processing equipment, cleaning containers and waste processing, unless there is no potential for exposure.
Engineering controls (e.g. process containment, local exhaust ventilation, general ventilation) by other measures to reduce exposure could be considered if the ones mentioned above cannot be applied. However, it is recognised that engineering controls need to be applied prudently to ensure protection of workers without compromising production. The selection of engineering control measures will depend on the requirements of each workplace, and should take into account the quantity and physical form of the nanomaterial as well as the task duration and frequency. It may be necessary for those working with nanomaterials to use a combination of methods to control exposure and risk.
Local and general ventilation helps prevent dispersion of airborne nanomaterials in the working area and to adjacent spaces. For removing nanoparticles from the exhaust air, an appropriate filtration system has to be used. This can be a multi-stage system with high efficiency particulate air filter (HEPA) or ultra-low penetration air filters (ULPA) as final filters.
Optimising process design and operational practices so that hazardous by-products and waste generation is mitigated will reduce exposure at the workplace.
Reduction of explosive risk of nanoparticles may be obtained by using four ‘specific safety barriers’:
- prevention barrier: reduction of accident probability by reinforced maintenance procedures that prevent fugitive emissions, accidental generation of explosive atmosphere, build-up of static electricity, accidental ignition sources;
- mitigation barrier: reduction of process factors, by lowering process temperature and pressures;
- mitigation barrier: reduce nanopowder severity parameters by substitution or dilution;
- protection barrier: increase the degree of protection for workers at risk.
Organisational measures should be used to supplement and accompany engineering controls, not replace them. For example, it can help to minimise the number of persons that may be exposed and the time and frequency of potential exposure.
Documenting safe procedures and working instructions for processes involving nanomaterials and making them available at the workplace will provide the basis for appropriate working practices and will be a reference for continual improvement.
Access to areas where exposure may occur should be restricted; safety and hazard signals should be used appropriately. There are no specifications in the legislation on how to label and sign nano-risks, but some guidance is available for labelling and some documents recommend the sign ‘nano-objects’ for areas with such risk.
Measures for proper maintenance, cleaning and personal hygiene should be taken.
Workers have to be trained on the safe handling of nanomaterials and on the control measures implemented. By law, they have to be consulted and to be able to participate in decisions that might affect their health and safety. Workers information should also include information on the specific hazards of nanomaterials and on the particular importance of the precautionary principle, due to the still limited knowledge on the health and safety hazards and exposure assessment of nanomaterials. Measures should be taken to make sure workers understand the risks and apply the control measures correctly
Personal protective equipment (PPE) including respiratory protective equipment (RPE) should be used whenever other preventive and protective measures are not sufficient or feasible. Incorrect selection, fitting or use of PPE can render it ineffective. Investment should be made in training, supervision and maintenance to ensure that PPE (especially RPE) provides the intended level of protection. HEPA filters, respirator cartridges and masks made with fibrous filters, protective clothing, goggles and gloves can be used. Filtering half masks have to fit well to the face because inadequate sealing impairs protective performance and increases the risk of exposure.
Protective clothing made from air-tight fabrics consisting of non woven textile seem to be more efficient to protect workers against nanoparticles than cotton and polypropylene. Nitrile, Latex, Neoprene gloves proved to be efficient for nanoparticles of around 10 nm diameter, when exposing the glove for few minutes. Workers should be informed on the limits of the protective equipment, its validity and correct use.
There are no regulatory occupational exposure limit (OEL) values specific for nanoparticles in EU legislation. Due to so many influencing factors (size, surface area, charge, composition, etc) with only partially known contribution to the toxicology it is difficult to estimate a No Observable Adverse Effect Level (NOAEL) or a Lowest Observable Adverse Effect Level (LOAEL) and thus establish a health-based occupational exposure limit.
In any case, the absence of OELs does not undermine the obligation of carrying out a risk assessment and implementing the hierarchy of prevention measures giving priority to elimination, followed by substitution, reduction at source with collective measures, etc.
Some organisations have suggested tentative OELs, such as the US National Institute for Occupational Safety and Health (NIOSH) which has proposed Recommended Exposure Limits (RELs) for:
- Respirable carbon nanotubes and carbon nanofibres - worker exposure should not exceed 1.0 micrograms per cubic meter (μg/m3) elemental carbon as a respirable mass 8-hour time-weighted average (TWA) concentration;
- Ultrafine (nano-scale) titanium dioxide - worker exposure should not exceed 0.3 milligrams per cubic meter (mg/m3) as a TWA concentration for up to 10 hours per day during a 40 hour work week;
- Pigmentary titanium dioxide (particle size greater than 100 nm) - worker exposure should not exceed 2.4 mg/m3 as a TWA concentration for up to 10 hours per day during a 40 hour work week.
So called “benchmark levels" have also been proposed. Benchmark levels may be used as a tool in assessing occupational exposure. They are no health-based limit values, but represent a pragmatic guidance level.
The British Standard Institute has suggested benchmark exposure levels for four nanoparticle hazard types:
- For insoluble nanomaterials a general benchmark level of 0.066 × OEL of the corresponding microsized bulk material (expressed as mass concentration) is proposed;
- For fibrous nanomaterials the proposed benchmark level is 0.01 fibres/ml;
- For highly soluble nanomaterials a benchmark of 0.5 × OEL of the corresponding microsized bulk material is proposed;
- For substances classified as carcinogenetic, mutagenic, asthmagenic or reproductive (CMAR) in their coarse form, the same hazards will be considered for the nano form and the suggested benchmark level is 0.1 × OEL (mass concentration) of the corresponding microsized material.
The German Institute for Occupational Safety and Health of the German Social Accident Insurance (IFA) has also developed recommendations for benchmark limits, using size and density of the nanoparticles as classification criteria. IFA proposed the following benchmark limits as increases over the background exposure to ultrafine particles during an 8-hour working shift, based upon its experience in measurement and the detection limits of the measurement methods currently employed:
- For metals, metal oxides and other biopersistent granular nanomaterials with a density of > 6,000 kg/m3, a particle number concentration of 20,000 particles/cm³ in the range of measurement between 1 and 100 nm should not be exceeded.
- For biopersistent granular nanomaterials with a density below 6,000 kg/m3, a particle number concentration of 40,000 particles/cm3 in the measured range between 1 and 100 nm should not be exceeded.
- For carbon nanotubes (CNTs) for which no manufacturer's declaration is available that the CNTs have been tested as safe against asbestos-like effects, a provisional fibre concentration of 10,000 fibres/m3 is proposed for assessment, based upon the exposure risk ratio for asbestos.
In addition, a number of companies have developed in-house exposure limits. There exists a degree of variability in the suggested limits, partly due to the data set upon which the exposure limit is based, but also because of the nature of the derivation process including what safety factors are applied. Despite this, it is clear that certain nanoparticles may be more hazardous than larger particles of the same substance. Therefore, it is important to be aware that existing OELs for a substance may not provide adequate protection from nanoparticles of that substance. Employers should seek to minimise worker exposure as far as reasonably practicable by using appropriate exposure control measures.
It is important to communicate the risks associated with the handling of nanomaterials and nanomaterial-containing products to workers directly using these materials to ensure that they are protected within the workplace. In addition, communicating to workers will provide assurance that the risks and hazards are managed, controlled and understood.
Safety Data Sheets (SDS) are a well-established and effective mechanism for transmitting appropriate safety information along the product supply chain. Given the remaining uncertainties regarding the potential hazardous properties of nanomaterials and the adequacy of existing control measures, it is important that any SDSs reflect current knowledge in the field as best as possible . Several groups have undertaken evaluations of SDSs for nanomaterials with a view to assessing their accuracy and reliability, and to highlight possible knowledge gaps precluding their development.
Guidance has been published by several organisations to support the preparation of SDSs for nanomaterials and nano-containing products and the appropriate communication of risk information throughout the supply chain. Key ISO recommendations for the preparation of SDSs for nanomaterials include:
- Date marking of SDSs due to the rapid expansion of data available;
- Clear statement that a material is in the nano-form, particularly when the same chemistry abstracts service (CAS) number as the bulk form is used;
- Declarations of where toxicological and eco-toxicological information is not available;
- A statement of whether available exposure limits are for the bulk or nano-form of the material or, in the absence of an exposure limit, application of the precautionary principle.
Another important form of risk communication in the workplace is the use of labelling and signage. A standardised approach to labelling and safety signs for use with nanomaterials does not currently exist and there are no officially recognised standard signage or consensus whether such a sign would be necessary. In the absence of such regulations and further information, a diligent and precautionary approach to labelling and signage is recommended. Labelling of packaging containing nanomaterials and nanomaterial-containing products should be visible and clear with a description of the contents in nano-form and any other chemicals and the known or suspected hazardous properties.
Occupational health and safety legislation
There is no specific occupational health and safety legislation for nanomaterials at EU level. The EU legislation that applies to nanomaterials in the workplace are those that generally applies to worker protection, chemicals (e.g. the Chemical Agents Directive - Council Directive 98/24/EC), as well as consumer and environment protection that could be in some cases relevant to the workplace.
The Framework Directive 89/391/EEC presents general principles of prevention and basic obligations for the employer and workers that apply to practically any occupational risks, therefore addressing also nanomaterials. Council Directive 98/24/EC on the protection of the health and safety of workers from risks related to chemical agents at work presents preventive principles and other measures for eliminating and, if not possible, substituting by less hazardous substances or reducing chemical risks to a minimum and also applies to nanomaterials. This means that the employer has the duty to assess the risks to workers from nanomaterials in the workplace and to protect workers adequately from these risks by implementing the hierarchy of prevention measures, giving priority to elimination of the risk, followed by substitution, collective technical control measures at the source of the risk, organisational measures and, as last resource, provision of personal protective equipment. Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work applies to substances that meet the criteria for carcinogenic and/or mutagenic substances, regardless of their size and introduces stricter provisions in particular with regards to substitution.
In 2011, a study was commissioned at the request of the European Commission to establish the potential impact of nanomaterials and nanotechnology at the workplace, evaluate the scope and requirements of possible modifications of relevant EU safety and health at work legislation (including Framework Directive 89/391/EEC and some of its supporting directives), and elaborate a guidance document to accommodate identified risks and concerns. As an outcome of this study, two guidance documents for those working with nanomaterials have been published by the European Commission, one aimed specifically at those handling nanomaterials in the workplace, and the other aimed at employers.[
The overarching European chemicals regulation is Regulation 1907/2006 on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) . REACH deals with substances, in whatever size, shape or physical state, and thus substances at the nanoscale are covered by REACH and its provisions apply. REACH requires all companies manufacturing or placing a substance on the EU market in quantities of 1 tonne or more per year to register that substance with the European Chemicals Agency (ECHA). Registration requires the submission of a dossier to the European Chemicals Agency (ECHA) containing hazard information and, where relevant, an assessment of the risks that the use(s) of the substance may pose and how these risks should be controlled.
Following a scientific and evaluation under the ‘REACH Implementation Projects on Nanomaterials’ (RIP-oNs),[SR1] ECHA published new appendices updated Chapters R.7a, R.7b and R.7c of the Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA) with recommendations for registering nanomaterials under REACH. The on-line registration form (IUCLID) was also updated to facilitate the identification of a substance as nanomaterial and a manual was published to help registrants. Based on further work by ECHA’s Nanomaterials Working Group (NMWG) and the Group Assessing Already Registered Nanomaterials (GAARN), further appendices to key REACH guidance documents are currently under consultation with a view to providing further advice in relation to nanomaterials. ECHA has indicated a tentative date of May 2017 for publication of the final versions of the appendices.
Regulation 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP Regulation) provides criteria for the classification of hazardous substances, as well as indications on labelling and packaging. Nanomaterials that fulfil these criteria for classification as hazardous must be accordingly classified and labelled. The CLP Regulation also provides an obligation to notify to the European Chemicals Agency (ECHA) all substances which meet the criteria for classification as hazardous substances, independently of the tonnage in which they are placed on the market.
The European Parliament resolution of 24 April 2009 called specifically on the European Commission to review legislation such as the workers’ protection legislation and REACH to ensure that the particular features of nanomaterials are adequately addressed by the EU legislative frameworks and that information to consumers and workers is improved, with appropriate labelling indicating the presence of nano-sized ingredients, regardless of their risks. In particular with regard to REACH, it requested the Commission to evaluate the need to review REACH, concerning among others:
- simplified registration for nanomaterials manufactured or imported below one tonne;
- consideration of all nanomaterials as new substances;
- a chemical safety report with exposure assessment for all registered nanomaterials;
- notification requirements for all nanomaterials placed on the market on their own, in preparations or in articles.
The Commission replied in October 2012 that important challenges relate primarily to establishing validated methods and instrumentation for detection, characterization, and analysis, completing information on nanomaterial hazards and developing methods to assess exposure to nanomaterials. They found that:
- current risk assessment methods are applicable, even if work on particular aspects of risk assessment is still required,
- within the REACH framework more specific requirements for nanomaterials have proven necessary. The Commission envisages modifications in some of the REACH Annexes.
In addition the Commission created a web platform with references to all relevant information sources, including registries on a national or sector level.  In parallel, the Commission launched an impact assessment to identify and develop the best means to increase transparency and ensure regulatory oversight, including an in-depth analysis of consequent data gathering needs. Its conclusions and the corresponding proposal for modification are being discussed in the CASG Nano, a subsidiary working group to the Competent Authorities for REACH and CLP (CARACAL).
There is no specific legislation solely for nano-enabled products in Europe. However, there is a general requirement on manufacturers to ensure a high level of product safety throughout the EU and ensure that only safe consumer products are placed on the market, laid out under the General Product Safety Directive (Council Directive 2001/95/EC). In addition, specific provisions on nanomaterials have also been introduced into several consumer product legislations, including in relation to biocides (Regulation 528/2012), cosmetics (Regulation 1223/2009), novel foods (Regulation 2015/2283), and food labelling (Regulation 1169/2011).
Governance of nanotechnology is considered to be essential for realising economic growth and societal benefits, protecting public health and the environment, and supporting global collaboration and progress. Given the scientific uncertainty associated with nanomaterials and its multi-disciplinary nature, nanotechnology presents significant new challenges for governance, most notably:
- the pace of nanotechnology development;
- the diversity of materials and applications;
- knowledge uncertainties specifically in relation to environmental health and safety (EHS) concerns and ethical, legal and social issues (ELSI);
- the adequacy of existing procedures;
- international harmonisation of approaches;
- awareness and perception of nanotechnology along the value chain.
Over the past decade, an international policy debate has emerged concerning appropriate mechanisms for the governance and regulation of nanotechnologies. The governance landscape for emerging technologies, including nanotechnologies, has recently been mapped out as part of a Cefic-LRI project,[SR1] with governance approaches ranging from requirements for an extension of existing regulatory frameworks, to ‘softer’ approaches such as codes of practice, reporting schemes, standardisation, and best practice guidance which may serve as a stop-gap in the absence of proper risk assessment and regulatory monitoring.
Three prominent governance frameworks have been applied in the context of nanotechnology, namely:
International Risk Governance Council (IRGC) Risk Governance Framework;
FramingNano Governance Platform;
Responsible Care® Global Charter.
Whilst these frameworks facilitate several desirable attributes for an optimal governance framework (such as the use of best available technology, flexibility and versatility, and stakeholder engagement), there remains some question as to whether these frameworks, in their current form, provide sufficient means or detail for effective implementation at a practical level. It is widely foreseen that effective governance will require a high level of cooperation, coordination and communication between various institutions and stakeholders, including those who develop, manufacture, market and regulate nano-enabled products, as well as representatives of civil society, in order to promote a proactive and adaptive process.
Voluntary codes of practice/conduct provide stakeholders with guidelines that support a responsible and open approach to research in their given field. Various voluntary codes have been published by different organisations in Europe including:
- Code of conduct for responsible nanosciences and nanotechnologies research elaborated by the European Commission;
- Responsible NanoCode for business, elaborated by the Royal Society (UK);
- BASF Code of conduct ‘Nanotechnology’;
- Swiss Retailer’s Association (IG DHS) Code of Conduct for Nanotechnologies.
These codes aim to establish a consensus of what constitutes good practice and provide guidance on what organisations can do to demonstrate responsible governance.
Voluntary schemes and networks, where organisations are encouraged to share data on nanomaterials, including toxicity or exposure levels, have been trialled on a temporary basis in a number of European countries, including in the UK and Germany. Given the limited success of these voluntary schemes, several European countries have introduced national-level mandatory reporting schemes to gather information on nanomaterials and gain an insight into levels of production, importation and distribution on the market.
The first of these schemes was launched in France during 2013. This was closely followed by a comparable scheme by the Danish Environmental Protection Agency (EPA), which had a deadline of 30th August 2015 for the first round of registration. The Belgian Council of Ministers has also set up a national nanomaterial reporting scheme, which became operational from January 2016. The key requirements of these registries have been summarised by SAFENANO,[SR1] including links to further information on the relevant government websites.
A number of other European countries are considering introducing mandatory reporting schemes, including Norway, Sweden, and Italy. At a European level, following an impact assessment to identify and develop the most adequate means to increase transparency and ensure regulatory oversight on nanomaterials, the European Commission concluded that an EU-wide mandatory registry would be too costly for both industry and authorities. Instead, an EU observatory for nanomaterials is currently being developed by ECHA. The observatory will not result in new data, but will collate information that is already available on nanomaterials and present it in an easily understandable way. Information sources for the observatory will include data generated by various pieces of EU legislation regulating the safe use of nanomaterials (e.g. REACH, biocides, cosmetics), from national inventories, research projects, and market studies. The observatory will be developed in three phases. The first phase, which will cover what nanomaterials are, how they are used, and relevant safety issues – including links to relevant research projects – is set to go live in summer 2017. Later phases will include search functionalities and more detailed product information.
One of the building blocks of a safe, integrated and responsible approach to the development of nanotechnologies is standardisation. Standardisation activities in the nanotechnology field are taking place at the international level and in many countries, involving a broad range of interests and organisations. At the forefront of these activities are the following five bodies:
- International Organisation for Standardization (ISO);
- European Committee for Standardization (CEN);
- British Standards Institution (BSI);
- ASTM International;
- OECD Working Party on Manufactured Nanomaterials (WPMN).
A compilation of nanotechnology standards available from these organisations has been prepared by SAFENANO.
Best practice guidance
Numerous organisations have published best practice guidance for the safe handling and use of nanomaterials. Current guidance recognises the risks involved in the development, manufacture, use, clean-up and disposal of nanomaterials in order to develop and implement effective precautionary strategies and adequate control measures to minimise potential exposure. Key guidance documents include:
- Guidance on the Protection of the Health and Safety of Workers from the Potential Risks related to Nanomaterials at Work, European Commission;
- Working Safely with Manufactured Nanomaterials, European Commission;
- Guide to Safe Handling and Disposal of Manufactured Nanomaterials, BSI;
- Health and safety practices in occupational settings relevant to nanotechnologies, ISO;
- Building a Safety Program to Protect the Nanotechnology Workforce: A Guide for Small to Medium-Sized Enterprises, NIOSH;
- Using Nanomaterials at Work - Including Carbon Nanotubes (CNTs) and other High Aspect Ratio Nanomaterials (HARNs), UK Health and Safety Executive;
- Working Safely with Nanomaterials in Research and Development, UK Nanosafety Group;
- Safe Handling of Nanomaterials and Other Advanced Materials at Workplaces, BauA;
- Best Practices Guidance for Nanomaterial Risk Management in the Workplace, IRSST.
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