What?

What are the Malta Initiative's Objectives?

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:

  • Steer attention towards priorities for the work on test, measurement and verification procedures
  • Support national and international exchange and cooperation
  • Bring together different stakeholders in a constructive dialogue
  • Strengthen trust in enforceable legislation and safe innovation

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        From Science to Regulation

        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:

        • A formal structure for stakeholder engagement should be established to allow a continuous early identification of required new or adapted OECD Test Guidelines.
        • OECD Member Countries should encourage universities, professional societies, industry sector bodies and other relevant stakeholders to include Test Guideline development in their curricula and training to help raise awareness of the role and importance they play in society.
        • OECD Member Countries should provide long-term, dedicated additional funding to help ensure that TGs are kept up-to-date and relevant to regulatory requirements, especially for new chemicals and materials, ensuring a prioritised and focussed approach.
        • The European Commission, Member States and stakeholders should support the Malta Initiative’s European Test Methods Strategy as proposed in its position paper.

        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.

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              What has been achieved so far?

              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:

              • TG 413 Amendment: Subchronic Inhalation Toxicity: 90-day Study (published 2017)
              • OECD TG 318: Dispersion Stability of Nanomaterials in Simulated Environmental Media (published 2017)
              • New OECD GD 318: Testing of Dissolution and Dispersion Stability of Nanomaterials, and the Use of the Data for Further Environmental Testing and Assessment (published 2020)
              • New OECD TG 125 on Particle Size Distribution of nanomaterials (published 2022) (Report from October 2022)
              • Development of an new OECD TG: Transformation of Nanomaterials under Environmental Conditions (WNT project 3.16; work in progress
              • OECD GD 342 (Guidance Document on testing Nanomaterials using OECD TG No. 312 “Leaching in soil columns” (lead UBA; in cooperation with Fraunhofer IME)
              • Development of an OECD GD or TG to determine the environmental fate and behaviour of nanomaterials – dissolution and solubility rate (WNT project 3.10; work in progress)
              • Revision of statistical Guidance on OECD Test Guidelines (OECD Series on testing and assessment no. 54) (work in progress)

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