Factsheet: Risk Assessment of Nanomaterials in a Regulatory Context

This fact sheet provides an overview of the existing risk assessment procedures for manufactured nanomaterials as well as details and comments on the most relevant on-going developments.

The increasing amounts of products that contain nanomaterials give rise to concerns regarding their human health and environmental safety. Due to their small size, nanomaterials exhibit very specific properties that depend not only on their chemical composition, but also on their surface characteristics and shape (see Toxicity of Engineered Nanomaterials). Nanomaterials can therefore interact with organisms (plants, animals or humans) differently from other chemicals of the same chemical composition. Some nanomaterials have been used in products on the market for decades. Examples of “traditional” nanomaterials are carbon black (used in tyres) or synthetic amorphous silica (used in toothpaste or as an anticoagulant in food products). Other nanomaterials like carbon nanotubes (CNT) (used as polymer additives, paints, coatings and fuel cells) and quantum dots (used in electronics and flat screen displays) were more recently introduced to the market. To date, nanomaterials are used in a wide range of products, including mass applications such as toothpaste, sports equipment, and yoghurt to clothing, paint, batteries and cosmetics. The global market for nanomaterials has been estimated at 11 million tonnes per year.

In theory, manufactured nanomaterials are subject to the same environmental, worker and health protection regulations as any substance or material. However, the effectiveness of the regulatory framework to address nano-specific risks is limited due to their specificities and continuing knowledge gaps about the environmental and health impacts of nanomaterials. Another hurdle for the effective enforcement of regulation is the lack of standardised testing methods for nanomaterials and ongoing disagreement on terminology and definitions.

The risk assessment (RA) process describes procedures to identify, evaluate, characterise, and interpret the risks of a substance. Governments and regulatory bodies use the outcomes of RAs to adopt risk-management measures, i.e.: the measures put in place to protect the health and safety of the public, consumers, workers and the environment from potential or identified risks.

Read full factsheet.