Governmental bodies take a central role in the development and update of OECD TGs to enable safety testing of chemicals on an international standard and make legislation enforceable.
Ministries and Directorates General of the EU share information on regulatory needs and upcoming new regulatory requirements and policy goals
Can initiate and fund new TG/projects
Ministries and Directorates General of the EU provide information on the regulatory need(s) and the potential (international) regulatory applicability
Can participate at WNT, WPMN and other OECD bodies if nominated as part of the national delegation or as project leading institution
Ministries and Directorates General of the EU can participate at WNT, WPMN and other OECD bodies if nominated as part of the national delegation or as project leading institution
Ministries and Directorates General of the EU can participate at WNT, WPMN and other OECD bodies if nominated as part of the national delegation or as project leading institution
Ministries and Directorates General of the EU can initiate and fund updating of TGs/GDs
A government is typically organised into government departments, known as ministries or Directorates-General (DGs) in the EU, which are responsible for different policy areas. Ministries / DGs develop, implement and manage policy, law, and funding programmes. In addition, they deal with administrative issues and manage programmes set up by the government.
Ministries and DGs in their role of implementing and managing policies and laws, can share insights on (future) regulatory requirements, influencing needs in TG development.
Ministries / DGs can set priorities and financially support projects for TG development.
National Coordinators (i.e. working in the Group of National Coordinators of the OECD TGs programme (WNT)) and/or Members of the national delegation (i.e. working in other working groups such as the Working party on Manufactured Nanomaterials (WPMN)) can come from Ministries / DGs, which will thus be directly responsible for their country’s representation at OECD instances. They can also act as project-leading institutions. In such cases, Ministries and DGs may be directly responsible for leading Test Guidelines (TG) or Guidance Document (GD) projects and nominating experts, or providing comments on ongoing OECD projects (see Roles section as Member country or Leading institutions).Directorates-Generals and ministries are responsible for setting up EU / national funding programs. The Directorate-General for Research and Innovation (DG RTD), for example, proposes, discusses and finally publishes calls for research proposals in Horizon Europe. Thus ministries and DGs might be a source for funding projects to develop and amend OECD TGs/GDs.
Make regulation enforceable and enable testing on a sound scientific level
Communicate where regulation is struggling to receive meaningful information
Communicate on upcoming regulations and policy strategies that will require new TGs&GDs
Ensuring the newly developed or adapted TGs/GDs are fit for regulatory purposes
Governmental agencies share information on regulatory need(s) and suggest TGs required for regulatory programmes
They share knowledge of processes and connections to other TGs/GDs
Governmental agencies provide information on the regulatory need(s) and the potential (international) regulatory applicability
Support the OECD process in Working Parties and Expert Groups
Can participate at WPMN and other OECD bodies if part of the national delegation or as project leading institution
Governmental agencies can help to fine-tune the validation study to support decision-making for regulators who participate in the validation study
Can provide experts and join interlaboratory comparison
Can participate at WPMN and other OECD bodies if part of the national delegation or as project leading institution
Governmental agencies can ensure that the results from the TG/ GD are covering the regulatory needs if part of (Ad Hoc) Expert groups
Can participate at WPMN and other OECD bodies if part of the national delegation or as project leading institution
Governmental agencies give feedback if a TG/GD is regularly used and if the data generated are useful for regulation
Can recommend TGs to companies to comply with regulation, and suggest new TG updates.
Accept TGs in regulatory compliance
Governmental agencies are responsible for implementing legislation (e.g. ECHA, EFSA) and are tasked with research, development, policy advice and sovereign tasks. The federal agencies operate at the interface between science and politics and translate findings from the scientific system for use in the worlds of politics, safety and health, society and vice versa. This can include ensuring workplace safety, consumer safety and protecting the environment. Some agencies focus only on chemicals, some will be part of a wider agency responsible for other areas, such as other consumer product areas, wider environmental issues (such as agriculture) or wider safety at work issues.
These agencies typically report directly to a national ministry or Directorate-General, which will be the government body responsible for passing legislation, with the agency being the body responsible for enforcing the laws.
Governmental agencies can play different roles in Test Guideline (TG) development, depending on their core remit. Some agencies will be directly responsible for their country’s participation in OECD as the National Coordinator at the Working Group of the OECD Test Guidelines programme (WNT). Others will join their national delegation to represent their country at OECD meetings (e.g. Working Party on Manufactured Nanomaterials) or will participate in expert groups. Agencies can play a role as an initiator of a TG in pointing out needs for regulatory testing. European Chemicals Agency (ECHA), for example, may advise on the regulatory needs for a particular project to be developed at the OECD (i.e. Pre-OECD development phase) based on the output of an expert group meeting. Governmental agencies may also lead and contribute to TG development. Most TG developments are led by governmental agencies. They also play an important role in commenting on project proposals and (draft) TGs/GDs to ensure their regulatory applicability.
Governmental agencies fund their work through two main means. Most will have an annual budget from the responsible governmental ministry. For work in the OECD Test Guidelines Programme, this may also be supplemented by project funding, such as Framework funding from the European Commission or National funds (See Financial support process for further details).
Health Canada, Environmental Health Science and Research Bureau; Agency for Food, Environmental and Occupational Health & Safety (ANSES, France); Federal Environmental Agency (UBA, Germany); National Research Centre for the Working Environment (NRCWE, Denmark); European Chemicals Agency (ECHA); European Food Safety Authority (EFSA)
Make regulation enforceable and enable testing on a sound scientific level
Communicate where regulation is struggling to receive meaningful information
Ensuring the newly developed or adapted TGs/GDs are fit for regulatory purposes
Malta initiative facilitates the discussion amongst OECD Member countries on which TGs/GDs are to be drafted/revised
Initiates research calls to support the development of TGs/GDs
Supports the discussions with experts through e.g. workshop
Malta initiative supports the discussions with experts through e.g. workshop
Malta initiative supports the discussions with experts through e.g. workshop
Malta initiative facilitates the discussion amongst Member countries and other stakeholders on which TGs/GDs are to be drafted/revised
In the Malta Initiative, a voluntary network without an official mandate, representatives of European countries, several Directorates-General of the European Commission, the European Chemicals Agency (ECHA), authorities, research institutions, universities, NGOs, and industry work together on a voluntary and self-organised basis. They work together to find possibilities for developing and amending the measurement and test methods required to enforce legislation (particularly in the field of chemicals). In order to make the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH regulation) enforceable for nanomaterials, in a first step the Malta Initiative is committed to facilitating projects in which OECD Test Guidelines (TGs) are amended or developed for nanoscale substances. Other legislative areas, such as European regulations on biocides, cosmetics and plastic food packaging also refer to some extent to the OECD TGs when it comes to safety assessments for nanomaterials and thus also benefit from the amendments.
The Malta Initiative is committed to helping initiate and finance European Commission research projects seeking to update or develop new OECD Test Guidelines (initially for nanomaterials).
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
The Malta Initiative has no funding. Members and supporters do all work as in-kind contributions. The Malta Initiative is committed to helping initiate and finance European Commission research projects seeking to update or develop new OECD Test Guidelines (initially for nanomaterials).
Initiate the development and revision of OECD TGs/GDs to support testing of nanomaterials