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.
In line with existing OECD cooperation mechanisms, any country and organisation interested in actively working on amending 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.
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.
