The Malta Initiative

In 2017 (when Malta held the EU Council Presidency), Germany asked the EU Directorate-General for Research and Innovation to politically and financially support the development and amendment of OECD Test Guidelines (TGs) and Guidance Documents (GDs) to ensure that nano-specific issues are addressed. This was and is necessary as the European Regulation on Chemicals (REACH) and other laws and regulations demand data and test results for the registration, evaluation and authorisation of nanomaterials. The basis for these analyses are standardised and harmonised test methods such as the OECD Test Guidelines (TGs).

The OECD TGs are essential for all experts in industry, science and authorities involved in testing and evaluating chemicals (industrial chemicals, pesticides, cosmetics, etc.). They are a key instrument for obtaining comparable and reliable information on the properties and risks of chemicals. The European Chemicals Agency (ECHA) generally only accepts tests undertaken in line with recognised methods such as the OECD TGs. In addition, the TGs are included in the regulation on test methods (Regulation (EG) 440/2008) referred to in the European Regulation on Chemicals REACH.

The great strength of the OECD TGs as internationally recognised standard test methods is the Mutual Acceptance of Data (MAD) principle: The OECD member states must mutually and directly accept data from assessments undertaken in line with OECD TGs (assuming compliance with the Good Laboratory Practice (GLP) principle). This avoids superfluous assessments, reduces animal testing and helps save resources.

The Test Guidelines and Guidance Documents that are required for the assessments of “traditional chemicals” (according to the regulation on test methods (EC) 440/2008) can generally also be applied to nanomaterials. However, specific TGs and GDs are required for some areas due to the unique properties of nanomaterials. Insoluble and slightly soluble nanoparticles, for instance, have to be tested under different conditions than conventional soluble chemicals. Moreover, the currently available OECD Test Guidelines are not suited for generating the additional information required for the registration and authorisation of nanomaterials according to REACH.

The current OECD Test Guidelines are to be updated regularly with involvement of national experts from the OECD member states. However, there is no automatic trigger for this. Participation is voluntary and at the expense of the member states and thus requires a high level of commitment. Financial resources and a systematic approach, in particular, are necessary to maintain this commitment on a long-term basis.

The Malta Initiative encourages every country and organisation interested in actively working on amending existing OECD TGs and GDs or developing new TGs and GDs in line with existing OECD cooperation mechanisms. The Malta Initiative supports international cooperation in the spirit of the OECD. Any country and organisation interested in supporting the Malta Initiative is welcome.

Further information

• Who is the Malta Initiative? (Self-conception and members of the board, as of 07/2024) (PDF, 438 KB)
• Malta Initiative Position Paper (02/2024) (PDF, 563 KB)

Test results have to be found by using uniform, recognised test methods so they can be reproduced and compared in research and for regulatory needs. In the case of chemicals, for example, the OECD Test Guidelines (TGs) apply.

The great strength of these internationally recognised standard methods is the Mutual Acceptance of Data (MAD) principle: The OECD member states must mutually and directly accept the results of assessments undertaken in line with OECD TGs (assuming compliance with the Good Laboratory Practice (GLP) principle). This avoids superfluous assessments, reduces animal testing and helps save resources.

The OECD TGs are essential for all experts in industry, science and authorities involved in testing and evaluating chemicals (industrial chemicals, biocides, cosmetics, etc.). They are thus a key tool for receiving information on the properties and risks of chemicals. The European Chemicals Agency (ECHA) generally only accepts tests undertaken in line with recognised methods such as the OECD TGs. In addition, the TGs are included in the regulation on test methods (Regulation (EC) 440/2008) referred to in the European Regulation on Chemicals, REACH. REACH demands that all tests required for registration are conducted in accordance with methods set out in the regulation on test methods or methods recognised by the European Commission or ECHA as equivalent.

The Test Guidelines and Guidance Documents that are required for the assessments of “traditional chemicals” (according to the regulation on test methods (EC) 440/2008) can generally also be applied to nanomaterials. However, specific TGs and GDs are required for some areas due to the unique properties of nanomaterials. Insoluble and slightly soluble nanoparticles, for instance, have to be tested under different conditions than conventional soluble chemicals. Moreover, the currently available OECD Test Guidelines are not suited for generating the additional information required for the registration and authorisation of nanomaterials according to REACH. This includes, for example, information on the solubility or on the environmental fate of substances.

Other legislative areas, such as European regulations on biocides, cosmetics and plastic food packaging also refer to some extent to the OECD Test Guidelines when it comes to safety assessments for nanomaterials.

The Malta Initiative is committed to ensuring that the European Comission 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

• Malta Initiative Position Paper (02/2024) (PDF, 563 KB)

• The European Commission
• European institutions
• The following European countries: Germany, Austria, Denmark, Finland, France, Greece, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden and Switzerland
• Industry associations
• Non-governmental organisations

The Malta Initiative Board coordinates and harmonises the diverse activities of the Malta Initiative.

The Malta Initiative encourages everybody to contribute to OECD TG development. Any country or organisation interested in supporting the Malta Initiative is welcome.

Malta Initiative Position Paper (02/2024) (PDF, 563 KB)  

The Malta Initiative Board (MIB) was formed to coordinate the various activities of the Malta Initiative in a targeted way. The board members represent the EU member states, authorities of the European Commission, the EU NanoSafety Cluster (a cluster of all EU research projects on nanosafety) and industry. The members are renowned experts from the fields of physical-chemical characterisation, human health effects and environmental and biotic effects. The MIB members have strong links to various OECD working parties and the ISO/CEN as key institutions for standardisation. They are also familiar with OECD working practices and procedures. The members of the MIB act as ambassadors for the Malta Initiative and its spirit.

• Self-conception of the Malta Initiative and members of the Board (as of 07/2024) (PDF, 438 KB)

The Malta Initiative is a voluntary, non-governmental group; it does not have an official mandate or mission. The members of the Malta Initiative support its work through expertise. There is no institution-based funding or finance.

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 

• Gov4Nano – Implementation of Risk Governance: meeting the needs of nanotechnology
• RiskGone – Risk Governance of Nanotechnology
• NANORIGO – Establishing a Nanotechnology Risk Governance Framework
• NanoHarmony – Towards harmonised test methods for nanomaterials
• NANOMET –  Development and standardisation of methods for the safety testing of manufactured nanomaterials at OECD
• MACRAMÉ – Advanced Characterisation Methodologies to assess and predict the Health and Environmental Risks of Advanced Materials (since December 2022)

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)