The NanoHarmony project emphasises the importance of standardising safety test methods to enhance their regulatory acceptance. It highlights the benefits of standardisation, such as showcasing the value of developers' work, expanding their networks, and improving safety testing. However, challenges include a lack of knowledge about the process, inconsistent funding, and the lengthy duration of method development and validation for regulatory acceptance. To address these issues, NanoHarmony has created resources like a white paper, training modules, and the OECD TG/GD Process Mentor to guide developers through the standardisation process.

NanoHarmony encourages the standardisation of safety test methods

Researchers from the European NanoHarmony project recently published recommendations for scientists on how to advance their newly developed safety testing methods into a standard or an Organisation for Economic Cooperation and Development (OECD) Test Guideline (TG). They emphasise that standardisation offers several benefits: developers can demonstrate the value of their work, expand their professional network, and contribute to the improvement of safety testing.

International standards and test guidelines for chemical and material safety

Globally agreed methods are typically established by institutions like the International Organization for Standardization (ISO) or the OECD. These organisations help countries share data and compare results, which is important for facilitating trade. 

In Europe, OECD TGs for chemical and material safety are incorporated in legislation. They are regularly updated to keep pace with new scientific findings and better testing methods. These test guidelines help countries work together on chemical and material safety. Key principles like international harmonisation and Mutual Acceptance of Data (MAD) help create a level playing field and provide legal certainty for all stakeholders, while also lowering costs and minimising the need for repeated (animal) experiments. 

Incorporating scientific knowledge into standards and guidelines is challenging

Scientific knowledge is important for creating and updating safety test methods and standards. 
However, not all new scientific findings are incorporated in these standards and TGs. One reason is that many developers do not know how to design and validate methods suitable for regulation. Suitable methods must be clear, repeatable, and useful for decision-making.

The NanoHarmony project found several challenges. Developers often lack knowledge of the process; funding is not consistently available for all steps, and it is challenging for developers to see career benefits from this work. The process is lengthy, often longer than most research projects or a PhD trajectory, and needs agreement between many countries and experts.

Recommendations for uptake of new or updated methods into OECD test guidelines 

To successfully implement scientific knowledge into test guidelines, developers should connect with expert groups and National Coordinators of the OECD TG programme. Understanding the process is essential, and it involves several steps: developing a reliable method, obtaining support, validating the method, and writing the guideline. Validation is key because it proves a method is reliable and reproducible. Although funding may be available for initial research, developers should plan for financial support during the final steps of the process, when funding is often limited.

Additionally, NanoHarmony has created helpful materials for method developers. These include a white paper, training modules, online webinars, and an interactive tool called the OECD TG/GD Process Mentor. These resources help developers understand the steps required for harmonised/standardised methods, identify relevant contacts, and prepare their research for regulatory use.

Reflection by RIVM 

NanoHarmony’s findings and tools provide crucial information needed to improve the acceptance of new test methods for regulatory purposes. RIVM was actively involved in this project. As new types of chemical substances and materials emerge, and new concerns related to human and environmental health, as well as animal welfare, arise, there is a pressing need for new test methods. However, the development of these methods is lagging behind scientific progress, resulting in a gap between what scientists develop and what regulations need. 

To that end, the Dutch Ministry of Infrastructure and Water Management has taken steps to build support and establish a governance model for an EU European Union (European Union ) Test Method and Validation Strategy. These initiatives followed an initial thought-starter on the topic and a policy conference held in January 2025. The RIVM is actively involved in this strategy, as well as in the development, validation, and acceptance of test methods for chemical safety in general. 

The process from test method development to acceptance involves many organisations and can be complex. Furthermore, information on how to develop, validate and gain acceptance for a test method is scattered. It is therefore key to prioritise test method development and validation, and to clearly communicate regulatory needs. 

For instance, in the case of nanomaterials, prioritising these needs has led to the development of dedicated test methods and a list of further priorities from the Malta Initiative. Establishing priorities, ideally within a European Test Method and Validation Strategy, enables scientists to focus on the development of methods that are suitable for regulatory use.