Nanomaterials

What are nanomaterials? Nanomaterial health & safety concerns Nanomaterials in the workplace Nanomaterials in consumer products Legislative obligations Additional guidance

What are nanomaterials?

Nanomaterials are particles that are so small that we can only see them using a microscope. Some nanomaterials are natural (e.g. pollen and sand), others are unintentionally made (e.g. car exhaust fumes), while others are purposely manufactured. Being small sometimes means that nanomaterials behave differently compared to the same substance in bigger sizes, which may influence the potential risk. There are large gaps in our knowledge about their associated health hazards, therefore particular care must be taken in the management of these materials.

In a legal context, the European Commission has provided a recommendation on how to define a nanomaterial based solely on the size of the constituent particles of a material, without regard to the hazard or risk. This definition covers natural, incidental or manufactured materials and underpins the implementation of regulatory provisions for this group of materials.

The recommended EU Commission definition for nanomaterials states that a nanomaterial is:

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.

For more information on the EU Commissions definition, including the reviews and Q & A’s related to its recommendation please see the Commission website.

Nanomaterial health & safety concerns

Just like any other chemical substance, some nanomaterials are hazardous and others not. The nanoscale of the particles does not in itself imply a hazard. Instead the potential effects are based on the adverse effects a nanomaterial may cause and the amount taken up by an organism (humans or an animal).

A number of manufactured nanomaterials have however been associated with health hazards. Research by the scientific committee on emerging and newly identified risks (SCENIHR) has indicated that some nanomaterials can be taken up in the lungs causing inflammation and tissue damage, fibrosis and tumour generation. The cardiovascular system may also be affected. Some types of carbon nanotubes can lead to asbestos-like effects. As well as the lungs, nanomaterials have been found to reach other organs and tissues including the liver, kidneys, heart, brain, skeleton and soft tissues.

As a result of their small size and large surface area, particulate nanomaterials in powder form may present risks of explosion, whereas non-nanosized versions of the same substance may not.

Nanomaterials in the workplace

Workers may come into contact with nanomaterials at any stage in the supply chain, from the manufacture of chemicals to the treatment of products. The production and use of nanomaterials are governed by EU and national legislation, but workers may be exposed to nanomaterials at different stages of the supply chain, where they may not even know that they are in contact with nanomaterials.

Exposure may therefore occur in a variety of occupational settings such as in the automotive industry, cosmetics, electronics, medicines, medical technology and textile manufacturing. Using nanomaterials at the workplace does not mean that there is a risk, or that the risk cannot be controlled. A risk assessment must be carried-out by employers to assess the hazards associated with the use of nanomaterials in the workplace, and the possibility of worker exposure. Any such risk assessment must take into account the physical and chemical characteristics of the nanomaterial used, which includes the size, shape and structure of the nanomaterial e.g. the potential possible persistence of nanomaterials in the shape of long, rigid fibres. If nanomaterials could be persistent in the body, this adds to their potential to cause harm.

Nanomaterials in consumer products

The use of nanomaterials is rapidly expanding and a large number of everyday products on the European market contain nanomaterials. Nanomaterials offer significant technical and commercial opportunities in the EU, and nanotechnology has been identified by the European Commission as a key enabling technology.

Consumers may be exposed to manufactured nanomaterials contained in paints, sun-screens and other cosmetics, food and food packaging, textiles, sports equipment, electronics and batteries. Their function may be:

• UV-blocking
• self-cleaning
•  anti-bacterial
• water repellent
• thermal insulation
• enhanced strength
• enhanced colour, texture, flavor and consistency of food
• water purification

For more information on nanomaterials

Search the European Union Observatory for Nanomaterials 

Legislative obligations

REACH & CLP 

REACH is the over-arching legislation applicable to the manufacture, placing on the market and use of substances on their own, in preparations or in articles. Nanomaterials are covered by the definition of a "substance" in REACH.

In December 2018 the EU Commission adopted Commission Reg EU 2018/1881 to amend the REACH annexes in order to introduce specifications for the registration of nanomaterials. These amendments will enter into force by the 1st Jan 2020 for new and existing registrations.

The amended provisions include:

• Requirement to identify and characterise nanoforms of substance covered by the registration
• Compilation of basic information on volumes and uses of nanoforms
• Clarifications on how obligations on substance apply to all nanoforms covered by the registration
• Introduction of requirements for adequate sample preparation, route of exposure and characterisation of test material when in nanoform
• Qualification of existing adaptation possibilities to ensure their responsible application to nanoforms
• Modification of information requirement where the test method is not applicable/informative for nanoforms

SDS

Amendments to REACH Annex II are to be introduced jointly with other changes that are required to ensure coherence with the work under UNECE Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

CLP

The classification, labelling and packaging of nanomaterials is similarly regulated through the CLP Regulation, although not explicitly mentioned, the regulation applies to nanomaterials as substances in their own right, or nanomaterials as special forms of a substance.

Amendments to REACH Annex II (the safety data sheet) and CLP to specifically incorporate provisions for nanomaterials are under assessment at the EU and UN level.

Safety, Health & Welfare implications for nanomaterials

The EU legislation on worker protection applies to nanomaterials, although it does not refer explicitly to these materials.  Of particular relevance are the Framework Directive 89/391/EEC, the Chemical Agent Directive 98/24/EC, and the Carcinogen and Mutagen Directive 2004/37/EC.

Exposure & monitoring

A key aspect of any risk assessment of hazardous substances is assessing its exposure. Therefore, it is essential to understand whether and how people may be exposed to nanomaterials in their daily lives, including at work and at home.

Evaluation of occupational exposure has traditionally been carried out using qualitative and quantitative tools. However, conventional sampling and detection methods for carrying out occupational hygiene monitoring may not be adequate for nanomaterial sampling and detection. Monitoring methods are under review by research organisations and other institutes such as the Health & Safety Executive (UK) and the National Institute for Occupational Safety and Health (US) (NIOSH).

Learn more about exposure to nanomaterials in the workplace.

Risk Assessment

Grouping of nanomaterials based on their physical structure and their classification is recommended for risk assessment. The following grouping criteria are suggested:

• Fibrous nanomaterials (i.e. insoluble and of a high aspect ratio)
• Nanomaterials from CMR substances (i.e. the larger form particle of the substance is already classified as a carcinogenic, mutagenic or reproductive toxin)
• Insoluble nanomaterials (i.e. insoluble or poorly soluble nanomaterials, but not fibrous or a CMR)
• Soluble nanomaterials (i.e. soluble nanomaterials not fibrous or a CMR)

As with any chemical substance, inhalable and poorly soluble nanomaterials in addition to nanomaterials derived from known CMR substances represent the greatest concern. Nano-sized materials in general have an increased capacity to reach and interact with tissues in the body, potentially enhancing any adverse effects on health.

Control Measures 

Although many uncertainties remain, there  is concern about the safety and health hazards of nanomaterials. Therefore, employers together with workers must apply a precautionary approach to risk management and the choice of prevention measures.

Employers must apply the hierarchy of controls in order to protect their workers from nanomaterials, in the absence of specifically developed occupational monitoring methodologies. More information on the hierarchy of control in our publication Your steps to chemical safety and on our website.

• Read EU-OSHA’s specific advice on how to manage risks of nanomaterials in the healthcare sector and in maintenance work. Other organisations have also produced useful information, for example on nanomaterials in construction and in furniture , or in research and development
• Discover how other companies have managed nanomaterials from our good practice examples of workplace management of nanomaterials
• Download guidance for workers  
• Download guidance for employers and health and safety practitioners 

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