The Malta Initiative is committed to ensuring that the European Commission initiates and finances research projects seeking to update or develop new OECD Test Guidelines (initially for nanomaterials). This is one of the foundations for ensuring that European legislation on chemicals (current focus is REACH) can be practically implemented. Appropriate legislation also means reliable support for long-term investments. Investments and innovation are only possible in the long term if existing laws are unambiguous and enforceable. Working for a solid basis for chemicals law – internationally standardised test methods – is thus also a measure to enable legislation to keep pace with innovative research developments.
The Malta Initiative thus aims to:
International agreement on methodologies to test and characterise chemicals and advanced (nano)materials is essential to protect human health and the environment. The OECD Test Guidelines Programme helps to develop harmonised agreed methods that can be used by OECD countries to implement their relevant regulatory regimes, ensuring that chemicals and advanced (nano)materials are safe and sustainable.
However, for regulations to be effective and for manufacturers to be able to comply with regulatory requirements, the OECD Test Guidelines (TGs) need to remain up to date and fit for purpose. In October 2023 the Horizon 2020 funded NanoHarmony project (https://nanoharmony.eu) published a White Paper on OECD Test Guideline development From Science to Regulation. Using feedback from relevant stakeholders, NanoHarmony makes eight recommendations in four key areas to help improve the effectiveness of the TG development process of moving new methods from science to regulation more efficiently.
Recommendations in the White Paper include:
Implementing the recommendations in the NanoHarmony White Paper will ensure more efficiency in developing new OECD Test Guidelines and allow regulations to keep pace with scientific innovations in the field of test developments and industrial innovation in new materials.
presentation file: ‘Towards Harmonisation of Testing of Nanomaterials for EU Regulatory Requirements on Chemical Safety – A Proposal for Further Actions’ (as of 11. July 2023) (PDF, 669 KB)
So far, the following projects have been launched to advance the development and amendment of the OECD Test Guidelines and Guidance Documents on nano-specific issues:
Financed under the European Union research programme:
Financed by the German Federal Environment Ministry:
presentation file: ‘Towards Harmonisation of Testing of Nanomaterials for EU Regulatory Requirements on Chemical Safety – A Proposal for Further Actions’ (as of 11. July 2023) (PDF, 669 KB)
Since 2017 the Malta Initiative, which is a voluntary network without an official mandate, has initiated developments and updates of OECD Test Guidelines (TG) and Guidance Documents (GD) to ensure that they are applicable to nanomaterials and (other) advanced materials.
In March 2024, the Malta Initiative released its Malta Initiative Priority List. This will help ensure that the harmonised methods that are required in the near future for nanomaterials and (other) advanced materials will be available. Ensuring that innovations in materials can come to the market and comply with regulations requires collaboration between experts from science, industry and authorities to set priorities for which test methods are required.
The Priority List has the following aims:
The Malta Initiative Priority List is a list of prioritised actions to support the development and amendment of OECD TGs for nanomaterials and (other) advanced materials. These are materials that have specific properties and behaviour due to their size, shape or structure. The List is a living document that will be updated every three years. It does not cover actions already ongoing in the OECD Test Guidelines Programme but highlights TGs that are still required. The Priority List has been brought together with the help of experts in the field of physical chemical properties, human and environmental toxicity. These experts include representatives from industry, academia and regulatory bodies.
The NanoHarmony project, funded through Horizon 2020, has established a web-based tool to guide stakeholders through the development process of OECD Test Guidelines and Guidance Documents – the NanoHarmony Process Mentor.
This interactive tool provides an understanding on developing OECD Documents, including when and how to prepare for required activities, highlighting the key start and end dates of the development process, plus who to involve in which activities and when. The tool provides multiple entry points for the different stakeholders with content tailored to their needs.
The NanoHarmony Process Mentor is intended for anyone with an interest in the OECD Test Guideline development process, including those interested in leading or participating in a Test Guideline development. It can be used by research projects who need to understand how their new methods can be taken into the OECD process, by university teachers who can educate their students on how science is used in regulations or by governments to train the next generation of regulatory scientists.
For this purpose, the Process Mentor also hosts the NanoHarmony Training Material that was also developed as part of the project. The NanoHarmony Training Material provides a low-level introduction to the topic of standards and harmonised OECD Test Guidelines and how science can contribute to this.
The NanoHarmony Process Mentor is available free of charge to anyone interested in OECD Test Guidelines (https://www.testguideline-development.org/).
Suitable, internationally standardised test methods are essential to ensure that legal regulations on the safety of chemicals and materials can keep pace with innovation. One of the aims of the Malta Initiative is to ensure that these methods are developed systematically and consistently with a view to European legislation.
In 2024 two configurations of the Council of the European Union – the Environment Council configuration and the Competition Council configuration (Research) – included this idea in their conclusions. All 27 EU member states agreed to this, giving the issue strong political weight.
At the initiative of the Netherlands, with the active support of Germany, the Environment Council configuration expressly encourages the development of test methods that can be used for regulatory purposes and requests appropriate funding. The Council also calls on the European Commission to develop a European Test method and Validation Strategy:
“THE COUNCIL OF THE EUROPEAN UNION (…) 32. STRESSES the necessity of sound testing methods to identify possible negative impacts of exposure to chemical substances and establish legislation to guarantee safe use of chemicals on several types of toxicological characteristics, while avoiding the use of animal testing as much as possible; ENCOURAGES the development of testing guidelines, cooperation and exchange of information between all actors to promote reproducibility and transferability of results; INVITES the Commission to develop a European Test Method and Validation Strategy; INVITES the Commission and the Member States to address any possible backlog in pre-validation efforts for existing testing methods and to incentivise adequate funding; (…)”
The Competitiveness Council (part research) takes up the issue in its conclusions on the Commission’s communication ‘Advanced materials for industrial leadership’. This communication states under the heading „6. FOSTERING THE PRODUCTION & USE OF ADVANCED MATERIALS (…) It is important to ensure that innovations in advanced materials are compliant with existing regulations and fit for purpose, this makes it necessary to put in harmonised methods and assessment tools for the characterisation and testing of advanced materials. It is also important for these harmonised methods and assessment tools to have gained regulatory acceptance. (…)”
At Germany’s initiative, actively supported by the Netherlands, the Competition Council configuration also emphasized this point in its conclusions: “The Council of the European Union (…) 4. (…) RECOGNISES the necessity for methods and assessment tools for the characterisation, testing and validation of advanced materials, and for the integration of circular economy principles and the conducting of comprehensive lifecycle assessments to ensure sustainable production, use, and disposal of advanced materials. (…)”
Currently, however, EU COM does neither call for nor fund corresponding research projects.
