Table of Contents
New Approach Methodologies (NAMs) are a set of innovative tools, technologies and strategies designed to improve the safety assessment of chemical substances, reducing the need for animal testing and grounded, ethically and scientifically, in the principles of the 3Rs (Replacement, Reduction and Refinement).
These methodologies offer faster, more ethical and more efficient approaches to identifying chemical risks to both human health and the environment.
Technologies used
- In vitro models: Biological systems, such as human cell cultures, that mimic the responses of the human body.
- In silico models: Computer simulations, based on artificial intelligence and machine learning, to predict how a chemical substance will interact with living organisms.
- Organs-on-chips: Microdevices that combine living cells to simulate specific functions of human organs.
- Biomarkers: Tools that make it possible to assess biological responses to exposure to chemical substances.
NAMs take advantage of advanced technologies, such as genomics, proteomics and metabolomics, to generate large amounts of data on the effects of chemicals at the molecular level.
These methods are integrated into risk assessment frameworks that combine information obtained from multiple sources to make regulatory decisions.
Benefits of NAMs
- Greater accuracy: NAMs can provide more specific and human-relevant results compared to animal testing.
- Cost and time efficiency: Assays are faster and cheaper than traditional testing.
- Ethics: They promote cruelty-free science by reducing animal experimentation.
- Scientific innovation: They help develop more modern and predictive methods.
Applications of NAMs
- Chemical regulation: NAMs are being adopted by global regulatory frameworks, such as the REACH Regulation in the EU, and by agencies such as the EPA in the US, to assess the safety of new and existing chemical substances.
- Pharmaceutical industry: They are used to predict the toxicity of new drugs before they reach human testing stages.
- Consumer products: They assess the safety of cosmetics, food and cleaning products.
- Environmental assessment: They analyze the impact of pollutants on biodiversity and ecosystems.
Although they are gaining popularity, regulators still need to work towards fully accepting these approaches as equivalent or superior to traditional testing. Harmonized protocols and standards are needed to ensure the validity and reproducibility of the methods, and the transition requires investment in new technologies and training.
In the EU, NAMs are integrated into the REACH Regulation and the Chemicals Strategy for Sustainability, promoting alternatives to animal testing.
In the US, the EPA leads the use of NAMs in chemical risk assessments, in line with the Toxic Substances Control Act (TSCA).
The United Kingdom is positioning itself as a global leader in the use of NAMs. To this end, it is carrying out a series of initiatives that reflect its commitment to incorporating more ethical and scientifically advanced methodologies for chemical safety assessment.
Canada, Japan and Australia are also exploring the use of NAMs to improve their regulations.
