The European Union is a confederation of 27 countries that operates according to a supra-national system of governance, under which member countries delegate some of their decision-making powers to a variety of EU institutions, including a Council comprised of member country representatives, an elected Parliament, and the Commission, an independent civil service.
These institutions are empowered to legislate on all matters within the EU’s jurisdiction, and laws passed at EU level have direct effect within the legal systems of member countries, in some cases overriding national laws.
In most cases, legislative proposals are initiated by the European Commission, which submits draft regulations, directives, decisions, recommendations and opinions to the Parliament and Council for amendment and approval. The Commission is divided into a number of Directorates General (DGs), each of which is responsible for overseeing different EU regulatory sectors. The following DGs with the greatest influence on animal use in testing and research:
- Enterprise & Industry(responsible for chemicals, cosmetics, pharmaceuticals, vaccines)
- Environment(responsible for biocidal products and revision of the EU animal experimentation directive)
- Health & Consumer Protection(responsible for agricultural pesticides, food additives, flavourings, genetically modified foods, and other food safety issues)
- Joint Research Centre(responsible for intramural research, and home to the European Centre for the Validatin of Alternative Methods)
- Research & Technology Development (responsible for EU-wide research policy and extramural funding).
A critical adjunct to the policymaking function of the Commission DGs is the practical implementation of EU law and policy, including the development of guidance concerning acceptable approaches to satisfying information requirements prescribed under EU legislation. In certain regulatory sectors, this implementation function has been delaged to several independent Agencies, including the following: