Malta Initiative

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Appropriate, clear and enforceable legislation is a key factor for long-term investments and innovation. Legislation has to keep pace with innovative research developments for citizens to place trust in innovation. 

Making chemicals law enforceable

In the Malta Initiative, 18 European countries, several Directorates-General of the European Commission, the European Chemicals Agency (ECHA), authorities, research institutions, NGOs, universities and industry work together on a voluntary and self-organised basis. The aim of this initiative is to make legislation enforceable, in particular in the chemicals sector. For this purpose, it is necessary to ensure that the essential test, measurement and verification procedures are available. Currently, the work is focussed on amending the OECD Test Guidelines in the area of nanomaterials to ensure that a nanomaterial-adapted REACH Regulation will become enforceable. Other legislative areas, such as European regulations on biocides, cosmetics and plastic food wrappings also refer to some extent to the OECD Test Guidelines when it comes to safety assessments for nanomaterials and thus also benefit from the amendments.

Amending OECD Test Guidelines

Germany laid the foundation for the amendment of the guidelines in 2017 when it asked the EU Directorate-General for Research and Innovation (DG RTD) to politically and financially support the development and amendment of the OECD Test Guidelines (TGs) and Guidance Documents (GDs) to ensure that nano-specific issues are addressed.

To achieve this, several projects were put to tender within the framework of Horizon 2020, the 8th EU Framework Programme for Research. The Malta Initiative arose during the Maltese EU Council Presidency on Malta.

As a further step, the initiative aims to generally call attention to the importance of test, measurement and verification procedures, which goes far beyond the area of nanomaterials.

Why does the Malta Initiative exist?

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 the OECD Test Guidelines (TGs) and Guidance Documents (GDs) to ensure that nano-specific issues are addressed. This has been 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, et cetera). They are thus a key tool for receiving information on the characteristics and hazards of chemicals. REACH requires that testing shall be conducted in accordance with the test methods laid down in the Test Methods Regulation (Regulation (EC) No 440/2008) or in accordance with other international test methods recognised by the Commission or the Agency as being appropriate. The OECD TGs are transferred into this regulation.

The great strength of internationally agreed standard methods is the Mutual Acceptance of Data (MAD) principle: The OECD member states must mutually and directly accept data generated in testing in accordance with OECD Test Guidelines (assuming compliance with the Good Laboratory Practice (GLP) principle). This avoids superfluous testing, reduces animal testing and helps save resources. According to the OECD, annual savings amount to 309 million euros.

The Test Guidelines and Guidance Documents that are required for the testing 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 characteristics 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, or no Test Guideline is available, for generating the additional information that is required for the registration of nanomaterials according to REACH. This includes information on the number size distribution and solubility.

The Test Guidelines are to be updated periodically with involvement of national experts from the OECD Member Countries. 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. Funding, in particular, is necessary to support this commitment.

In line with existing procedures at the OECD, any country and organisation interested in actively working on adapting existing OECD TGs and GDs or developing new TGs and GDs is most welcome to become an active contributor to the Malta Initiative. The Malta Initiative supports international cooperation in the spirit of the OECD.

Further information


Why are the OECD Test Guidelines so important?

Test results have to be generated 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 internationally agreed standard methods is the Mutual Acceptance of Data (MAD) principle: The OECD member states must mutually and directly accept data generated in testing in accordance with OECD Test Guidelines (assuming compliance with the Good Laboratory Practice (GLP) principle). This avoids superfluous assessments, reduces animal testing and helps save resources. According to the OECD, current annual savings amount to 309 million euros.

The OECD TGs are essential for all experts in industry, science and authorities involved in testing and evaluating chemicals (industrial chemicals, biocides, cosmetics, et cetera). They are thus a key tool for receiving information on the characteristics and hazards of chemicals. REACH requires that testing shall be conducted in accordance with the test methods laid down in the Test Methods Regulation (Regulation (EC) No 440/2008) or in accordance with other international test methods recognised by the Commission or the Agency as being appropriate. The OECD TGs are transferred into this regulation.

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 characteristics 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, or are not available, for generating the additional information that is required for the registration of nanomaterials according to REACH. This includes information on the number size distribution and solubility. Other legislative areas, such as European regulations on biocides, cosmetics and plastic food wrappings also refer to some extent to the OECD Test Guidelines when it comes to safety assessments for nanomaterials.


What are the Malta Initiative's objectives?

The Malta Initiative is committed to updating existing and developing new OECD Test Guidelines (with an initial focus on nanomaterials) to create the basis for the practical implementation of the European chemicals legislation (current focus REACH). Appropriate legislation also means reliable support for long-term investments. Investments and innovation are only possible in the long term if existing law is unambiguous and enforceable. Working for a solid basis for chemicals law – uniform test methods – is thus also a measure to enable legislation to keep pace with innovative research developments. The Malta Initiative thus aims to:

  • Strengthen trust in enforceable legislation and safe innovation.
  • Promote national and international exchange and cooperation.
  • Bring together different stakeholders in a constructive dialogue.
  • Set thematic priorities for the work on test, measurement and verification procedures.

Who supports the Malta Initiative?
  • The European Commission
  • European institutions
  • 18 European countries: Germany, Austria, Denmark, Finland, France, Greece, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden, Switzerland, the United Kingdom
  • Industrial associations
  • Non-governmental organisations

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

Any country and organisation interested in actively working on adapting existing OECD TGs and GDs or developing new TGs and GDs is most welcome to become an active contributor to the Malta Initiative.


What is the Malta Initiative Board?

The Malta Initiative Board (MIB) was formed to coordinate all the different 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 board ensures that the Malta Initiative strongly aligns the necessary research with regulatory needs. The members act as ambassadors for the Malta Initiative and its spirit.

Anke Jesse (Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, BMU) is chair of the Malta Initiative Board.

Further information


How is the Malta Initiative financed?

The Malta Initiative is a voluntary, non-governmental association. The members of the Malta Initiative support its work through expertise, direct funding or in-kind contributions. There is no institution-based funding or finance.


What has been achieved so far?

So far, four projects have been launched to advance the development and amendment of the OECD Test Guidelines and Guidance Documents to the unique characteristics of nanomaterials.