Currently, assessing health risks of food and feed, chemicals and consumer products, in many cases still requires results from animal studies. However, scientists around the world continue to work in accordance with the so-called 3R principle on replacing animal experiments (Replacement) and, where this is not (yet) possible, to reduce the number of animals (Reduction) and their suffering in experiments (Refinement) as far as possible. New Approach Methodologies (NAMs) that utilise a variety of technologies and methods such as cell cultures, (bio)chemical tests and computer simulations play a central role in this context.

In the research project NAMS4NANO, funded by the European Food Safety Authority (EFSA), scientists from 10 research institutes collaborate under the coordination of the German Federal Institute for Risk Assessment (BfR) and the Italian ‘Istituto Superiore di Sanità’ (ISS)to systematically analyse the existing NAMs for application in health risk assessment of nanomaterials (NM).

They identified more than 260 individual NAMs, several of which could already provide reliable results to support NM risk assessment. Nevertheless, many of these NAMs have so far only been used to a limited extent in the context of risk assessments, as the majority of them have not yet been validated and are hence not available as test guidelines (TGs) of the Organisation for Economic Co-operation and Development (OECD). The development and adoption of OECD TGs is a time and resource intensive process.

Therefore, the NAMS4NANO consortium also proposes an initial concept for how the existing NAMs could be integrated more rapidly in risk assessments. The researchers suggest the introduction of an accelerated recognition procedure for qualification of existing NAMs, whereby an EFSA expert panel could examine the regulatory readiness of individual NAMs. If the available data on specific NAMs are sufficient to prove their reliability and relevance, they could be recognised as valid to enable their use for well-defined, specific questions related to NM risk assessment in the food and feed sector. Also, this so-called "qualification" allows to better guide the method development, as in the process of qualification recommendations can be made for the further optimisation of NAMs that are not yet sufficiently mature. In this way, new methods can be applied much faster than before, at least in certain integrated risk assessment procedures for selected areas and contexts-of-use, where they can help to further reduce the number of animal experiments.

Nevertheless, the NAMS4NANO team emphasises that animal testing in risk assessment is unlikely to be completely replaced by NAMs in the near future. For the foreseeable long term, certain aspects and questions will continue to require investigations in a living organism.

Resources and more information:

• NAMs: More than just "alternatives to animal testing" New Approach Methodologies for health risk assessment of nanomaterials
• Nanotechnology – promoting uses of new assessment methods
• Proposal for a qualification system for New Approach Methodologies (NAMs) in the food and feed sector: example of implementation for nanomaterial risk assessment
• NAMs4NANO Project – promoting uses of new assessment methods
• NAMS4NANO - Integration of New Approach Methodologies results in chemical risk assessments: case studies addressing nanoscale considerations