The effects of nanomaterials in living organisms depend on their size, shape and composition. Reliable methods are needed to determine the effects of nanomaterials in mammals and aquatic organisms as well as their behaviour in the environment.
Various international organisations such as the Organisation for Economic Co-operation and Development (OECD) and the International Organization for Standardization (ISO) are developing standardised inspection, measurement and assessment methods in order to evaluate the health and environmental risks of nanomaterials. Employees of the Swiss federal offices are actively participating in these working groups.
OECD Working Party on Manufactured Nanomaterials (WPMN)
The aim of the WPMN, which was established in 2006, is to develop methods and strategies that contribute towards the safety of nanomaterials for people and the environment. This involves, among other things:
- Reviewing existing OECD test guidelines to assess their suitability for nanomaterials. If necessary, amending existing test guidelines or developing new ones.
- Providing freely available documents that present the research activities and strategies of OECD member countries on the safe use of nanomaterials, so called "Tour de Table" documents.
- Supporting international partnerships that are investigating risk assessment strategies.
- Developing guidelines on measuring and minimising exposure for employees, consumers and the environment.
- Promoting the sustainable use of nanotechnology by enhancing and expanding inventory data and lifecycle assessment (LCA) methods.
The methods used to test conventional chemicals can generally also be used for nanomaterials. Certain methods may need to be modified, for example to enable correct sample preparation or dosage of nanomaterials in the testing system. New methods, in particular to characterise nanomaterials, are currently being developed.
In 2007, a test programme was started to test in vivo & in vitro the potential risk that eleven different nanomaterials (fullerenes, S-MWNT, silver, iron, titanium dioxide, cerium oxide, zinc oxide, silicon dioxide, dendrimers, clay and gold) posed to people and the environment. Thanks to assistance from public authorities, industry and research bodies in equal measure, the results have been available since June 2015.
International standardisation organisations
The technical committees ISO TC 229 Nanotechnologies and CEN TC 352 are developing standards for nanotechnology terminology and naming conventions. These expert groups are also drawing up methods for measuring, characterising and testing the toxic properties of nanomaterials, and are preparing guidelines on handling nanomaterials safely. Measuring exposure to nanoparticles and assessing toxicity throughout their lifecycle is playing an increasingly important role. The NK 0201 standards committee of the Swiss Association for Standardization (SNV) is enabling its members to work directly with ISO TC 229 and CEN 352.
Chemicals: Information requirements and chemical safety assessment for nanomaterials under REACH
For substances that are manufactured in or imported into the EU in a nanoform in quantities of one or more tonnes each year, specific requirements for registration in line with the REACH Regulation have been applicable since 1 January 2020. Previously submitted registration applications for substances with nanoforms must be updated by the company responsible for the registration. The aim of this is to evaluate the specific risks involved in the handling of the nanoforms of substances and to develop and recommend appropriate risk management measures.
IT programs and reporting formats for nanomaterials have been modified. The updated IUCLID* software (version 6.4) enables nanoforms or groups of nanoforms to be recorded together with the relevant data relating to their properties and risks in other sections of the dossier.
*IUCLID is a software application used in OECD member states for regulatory registration purposes, in which data on the inherent hazardous properties of chemical substances can be recorded, stored, maintained and updated.
The European chemicals agency ECHA has published several nano-specific appendices to its guidelines on information requirements and chemical safety assessment under REACH.
Foods: Guidelines for assessing the possible risks of nanotechnology
The European Food Safety Authority (EFSA) has published guidelines for assessing the possible risks of nanotechnology in food and feed.
Cosmetic products: Guidance on assessing the risks of nanomaterials
In 2019, the Scientific Committee on Consumer Safety (SCCS) published guidance on assessing the risks of nanomaterials in cosmetics. This guidance forms the methodological basis for the safety report that has to be submitted as part of the registration process in accordance with the European Regulation on Cosmetic Products (EC No. 1223/2009). The document can be found on this page under ‘Documents’.
Medical devices: Guidance on assessing the risks of nanomaterials
In 2015, the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) published guidance on assessing the risks of nanomaterials in medical devices. This highlights what needs to be specifically taken into account for nanomaterials. This guidance can also be used for particles larger than 100 nm.
Last modification 21.05.2021