Modification date 20-04-2023 | 08:40

Chemical substances need to be safe for human health (for example consumers and workers) and the environment. Various EU-regulations and/or Dutch regulations are in place to ensure the safety of chemicals, e.g. for use in industrial processes, in food as food additives or contaminants, and in consumer products such as cleaning products or cosmetics. The information needed for chemical safety assessment is obtained from toxicological tests. These tests are designed to indicate whether a chemical has properties to cause toxic effects, among other toxicological endpoints, toxicity after acute or repeated exposure, irritation on eye and skin, or carcinogenicity. 

Traditionally, toxicity testing is performed in animal studies. In the last decades, increasing attention has been given to the 3Rs, the replacement, reduction and refinement of animal studies. This has led to the acceptance of OECD (Organisation for Economic Co-operation and Development) test guidelines for in vitro methods, next to in vivo test guidelines for these toxicological endpoints.  In the last few years, much focus has been on the research and development of tests towards the replacement of animal studies for toxicity testing. In the context of safety assessment, the term New Approach Methodologies (NAMs) is used. According to the definition of the European Chemicals Agency (ECHA): 

“NAMs include in silico approaches, in chemico and in vitro assays, as well as the inclusion of information from the exposure of chemicals in the context of hazard assessment. They also include a variety of new testing tools, such as “high throughput screening” and “high-content methods” e.g. genomics proteomics, metabolomics; as well as some “conventional” methods that aim to improve understanding of toxic effects, either through improving toxicokinetic or toxicodynamic knowledge of substances.“

Implementation of NAMs in chemical safety assessment is not straightforward. For more complex toxicological endpoints such as repeated dose toxicity, carcinogenicity and reproductive toxicity, no accepted test guidelines based on NAMs exists. An essential first step to accelerate the implementation of relevant, reliable and reproducible NAMs for use in chemical safety assessment is to gain insight into the steps to be taken from research and development of NAMs towards validation, acceptance and implementation as well as in the roles of the many stakeholders and organisations involved in this process. Therefore, RIVM has developed the Landscape New Approach Methodologies (NAMs) for the safety assessment of chemical substances.