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 Mata Initiative has been working to update OECD Test Guidelines (TG) and Guidance Documents (GD) to ensure that they are applicable to nanomaterials and (other) advanced materials. OECD TGs are essential for industry and regulatory authorities involved in the testing and evaluation of chemicals and to ensure that legislation works.
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.