RIVM on Advanced Materials, March 2024

By 2023, two European research projects related to the Malta Initiative were completed: Gov4Nano and NanoHarmony. These projects provided scientific support to thirteen OECD projects aimed at developing or modifying OECD Test Guidelines or Guidance Documents. However, more work is needed to finalise the OECD documents. The Malta Initiative has also identified further needs for harmonised test methods for future (advanced) materials and animal-free safety testing. The NanoHarmony White Paper guides on how to continue developing these test methods. However, it is uncertain how to identify and address future needs in the absence of resources for funding.

Test method development and the Malta Initiative

Having internationally agreed test methods for assessing the safety of chemicals, materials, and products is paramount to protecting human health and the environment. Harmonised and standardised test methods make it easier to enforce laws and regulations and support safe innovation. 

In 2017, Germany took the first step to improve European collaboration concerning test methods for nanomaterials. They established the Malta Initiative to speed up the adaptations of OECD Test Guidelines for nanomaterials. The European Commission provided dedicated funding for scientific support. In addition, representatives of EU European Union (European Union) Member States, the European Commission, authorities, industry, research institutions, universities and NGOs work voluntarily and self-organised to ensure test methods are available to comply with and enforce legislation. In 2023, the European research projects Gov4Nano and NanoHarmony were finalised. These EU-funded projects were directly linked with the Malta Initiative activities. Their finalisation raises concerns about how to continue developing test methods.

Why work on OECD Test Guidelines?

Since 1981, the OECD Mutual Acceptance of Data (MAD) has been in place. It allows member countries to accept each other’s data for safety assessments of chemicals and materials, as long as the testing is performed under Good Laboratory Practice and follows the OECD Test Guidelines. Some non-member countries have also joined the MAD system. The MAD system helps reduce the number of animals used for testing and avoids unnecessary duplication. 

In European legislation, most of the OECD Test Guidelines are incorporated in the European Test Methods Regulation, which enables industry to comply with the information requirements in the REACH Regulation

Results from the Malta Initiative 

The Malta Initiative has effectively finalised several OECD projects related to nanomaterials. These projects were supported by the NanoHarmony and Gov4nano projects and funded by Member States. However, not all thirteen OECD projects have been completed yet. And further updates on other OECD test methods are still necessary. A recent scientific publication and the Gov4Nano project’s roadmap provide an overview of the necessary updates. Recently the Malta Initiative published a Priority List to further substantiate the needs. 

Innovations in (advanced) material science and a push for animal-free testing require new approach methodologies and related test guidelines. 

How do we ensure up-to-date test methods? 

Test guidelines may need to be updated when there are scientific advancements, changes in laws or new developments in industry. Developments in material innovation, animal-free testing, and European policy focusing on safe and sustainable by design require ongoing changes to test methods or even new ones. 

To achieve this, different stakeholders need to work together in an organisational structure to keep the test guidelines current. The Malta Initiative Position Paper advocates establishing a formal European structure and received broad support from EU member states, industry, and the scientific community. Such a structure could also help secure funds for developing new guidelines and maintaining stakeholder collaboration. 

The NanoHarmony White Paper

The NanoHarmony project has published a White Paper that guides establishing a structure that aims to sustain test guideline development. This structure should aim for test guidelines that are applicable to all chemicals, not only to nanomaterials and/or advanced materials. In support of the Malta Initiative Position Paper, the White Paper gives detailed options for collaboration and funds. It further suggests including test guideline development in education and training to raise awareness of their importance in society. 

NanoHarmony also offers guidance through a website that helps stakeholders understand the OECD and its processes towards OECD test guidelines (TGs) and guidance documents (GDs). This 'OECD TG/GD process mentor' (www.testguideline-development.org) highlights the involvement of different actors and their different roles. The website also includes NanoHarmony training material to introduce the topic of standards and harmonised test methods and how science can contribute to this. 

Reflections by RIVM 

RIVM acknowledges the need for better collaborations among stakeholders to identify the need for test method developments and ensure the necessary funding. The recently published OECD Test Guidelines and Guidance Documents show that a platform like the Malta Initiative stimulates interactions on test method developments, leading to better and more effective test guideline development. RIVM actively participates in the Malta Initiative and has signed the Position Paper. 

The NanoHarmony project identified the scientific community's lack of knowledge of the test guideline development process. Therefore, the 'OECD TG/GD process mentor' and training materials are valuable outputs from the project. In the long run, however, it may be beneficial that OECD hosts this website. With OECD hosting, it will be easier to keep the information on processes, contacts, etc., up to date.

RIVM on Advanced Materials, March 2024