The Malta Initiative

This page summarises the concept of the Malta Initiative.
It is a self-organised group without any legally binding status.

Innovation is one of the key factors in securing the wealth of current and future generations. To ensure the trust of citizens in innovation, legislation has to keep pace with innovative developments. Appropriate and clear legislation is a key factor for long-term investments. International collaboration at OECD level is one element in addressing the global challenges associated with innovation. The OECD Council Decision on Mutual Acceptance of Data (MAD) is a legally binding instrument in OECD member countries and non-OECD countries which have adhered to them (there are currently six). MAD is an important instrument in facing these global challenges of testing nanomaterials. In essence, MAD means that data collected as part of a regulatory risk assessment of a chemical in one country must be accepted (in a legal sense) in all countries, provided that (an) agreed OECD Test Guideline(s) has/have been used and the OECD Principles of Good Laboratory Practice have been applied during the collection of the data. MAD avoids the double testing of substances, reduces the amount of animal testing and saves on resources.

Generally, Test Guidelines (TG) and Guidance Documents (GD) for the testing of 'traditional' chemical substances are also applicable to nanomaterials. For a number of endpoints, however, TGs/GDs do not address specific information requirements when dealing with nanomaterials, or are considered not applicable for the testing of nanomaterials.

The "Malta Initiative" (MI) arose during the Maltese EU Council Presidency in 2017, when Germany initially approached the EU Directorate-General for Research and Innovation (DG RTD) to request political and financial support to develop and amend TGs and GDs to ensure that nano-specific issues for fulfilling regulatory requirements are addressed. The Malta Initiative brings together a group of EU member states, the European Commission (notably the DG RTD, DG ENV, DG GROW and JRC), ECHA, industry and other institutions committed to this aim and welcomes additional international collaborators.

In line also with existing procedures at the OECD, any country or organisation with expertise interested in working on adapting existing OECD TGs or developing new OECD TGs and/or GDs is welcome to become an active contributor to the "Malta Initiative".

The activities of the MI are supported through national, international and EU resources by means of direct funding, in-kind contributions, or providing expertise.

Austria, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden, Switzerland, United Kingdom, ECHA, European Commission and BIAC currently support the Malta Initiative.

The Malta Initiative Board

An advisory body, the "Malta Initiative Board" has been formed to facilitate and steer the activities of the MI. The MI Board members have been selected in order to represent EU member states, European Commission Directorates-General and agencies, the EU Nano Safety Cluster (NSC), and industry (notably through BIAC). Furthermore, members have been selected in order to include renowned experts from three relevant fields of expertise, namely: physical-chemical characterization; environmental and biotic effects; and human health effects. The board members also have strong links to various OECD working parties and other groups (e.g. ISO/CEN) and are familiar with OECD working practices and procedures.

The Board ensures that the MI focuses with emphasis on regulatory needs. The members are expected to act as "ambassadors" for the MI and its spirit.

Members (sorted by last name):

Member

Representing

Flemming Cassee

(deputy Eugenia Valsami-Jones)

NanoSafety Cluster (NSC), EU

Emeric Frejafon

Institut national de l'environnement industriel et des risques (France)

Monique Groenewold

(deputy Eric Bleeker)

National Institute for Public Health and the Environment (RIVM), The Netherlands

Elisabeth Heunisch

Federal Institute for Occupational Safety and Health (BAuA), Germany

Jenny Holmqvist

(deputy Celia Tanarro)

European Chemicals Agency (ECHA), EU

Anke Jesse

Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU), Germany – chair

Thomas Kuhlbusch

Federal Institute for Occupational Safety and Health (BAuA), Germany

Juan Riego-Sintes

(deputy Kirsten Rasmussen)

European Commission (JRC-Ispra), EU

Kathrin Schwirn

(deputy Doris Völker)

German Environment Agency (UBA), Germany

Jacques-Aurélien Sergent

(deputy Karin Wiench)

The Business and Industry Advisory Committee (BIAC) –Solvay, Belgium

Anne Mette Zenner Boisen

Ministry of Environment and Food of Denmark, Denmark