This acronym takes its initials from the expression “ New Approach Methodologies “.

This is a concept that brings together technologies aimed at improving the efficiency and quality of testing new products for regulatory purposes, particularly in toxicology, without using animals.

Where does this concept come from?

Two reports by the National Research Council (NRC) of the US Academies of Sciences, in 2007 and 2009 – both of which called for “science-based decision-making” in the field of human health risk assessment – are at the root of these developments.

In Europe, procedure REACH called for the same changes in the way chemicals are assessed for toxicity.

What are the advantages over “animal” methods?

The development of effective and reliable NAMs for assessing product safety is not only important for reducing the use of vertebrate animals, but also represents a scientific improvement for human health and the environment.

In 2000, a report assessed the predictive power of animal studies in relation to human toxicities observed in clinical trials, concluding that non-rodents were predictive of only 63% of toxicities observed in humans, and rodents of 43% (Olson et al., Regul. Toxicol. Pharmacol. 2000), leaving clear room for improvement.

What’s new?

The response to these challenges for a paradigm shift towards the use of NAMs for product safety assessment has led to an explosion of initiatives from many organizations, both public and private. NAMs should facilitate the replacement of animal testing by combinations of in silico predictive models, in vitro or in chemico testing and computational models of external and internal exposure. These methods promise to speed up testing procedures and improve their accuracy.

What are the obstacles?

As with all methods, it is necessary to determine their suitability for risk assessment on the basis of precise criteria. The pace of development of these new methods has increased in recent years, but the procedure validation process has not kept pace.

FRANCOPA observes that “the cumbersome nature of the validation process is incompatible with the rapid evolution of knowledge, which explains the lack of success of some of these methods, which are already obsolete by the time they are validated”.

Any prospects?

To date, the main NAMs used in regulatory testing are for the following uses: skin irritation or corrosion, skin sensitization, skin absorption, eye irritation or corrosion, inhalation, endocrine disruption, genotoxicity.

To accelerate the acceptance of NAMs in practice, it is necessary to coordinate the many initiatives.

This need for standardization led a multi-stakeholder group to propose a common definition framework and development methods.