A
regulation is a legislative act of the
European UnionThe European Union is an economic and political union of 27 Member States, located primarily in Europe. Committed to regional integration, the EU was established by the Treaty of Maastricht on 1 November 1993 upon the foundations of the pre-existing European Economic Community...
which becomes immediately enforceable as law in all member states simultaneously. Regulations can be distinguished from directives which, at least in principle, need to be
transposed into national lawIn international law incorporation is the process by which countries who are parties to international agreements pass domestic legislation that gives these agreements force under their respective national laws. Whether incorporation is necessary depends on a country's domestic law...
. Regulations can be adopted by means of a variety of
legislative proceduresThe legislative procedures of the European Union are the ways in which the European Union enacts legislation. The procedure used for any given legislative proposal depends on the policy area in question...
depending on their subject matter.
The legal basis for the enactment of regulations is article 249 of the Treaty establishing the European Community and, as such, regulations only apply within the European Community pillar of the European Union.
- Article 249
- In order to carry out their task and in accordance with the provisions of this Treaty, the European Parliament acting jointly with the Council, the Council and the Commission shall make regulations and issue directives, take decisions, make recommendations or deliver opinions.
- A regulation shall have general application.
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A
regulation is a legislative act of the
European UnionThe European Union is an economic and political union of 27 Member States, located primarily in Europe. Committed to regional integration, the EU was established by the Treaty of Maastricht on 1 November 1993 upon the foundations of the pre-existing European Economic Community...
which becomes immediately enforceable as law in all member states simultaneously. Regulations can be distinguished from directives which, at least in principle, need to be
transposed into national lawIn international law incorporation is the process by which countries who are parties to international agreements pass domestic legislation that gives these agreements force under their respective national laws. Whether incorporation is necessary depends on a country's domestic law...
. Regulations can be adopted by means of a variety of
legislative proceduresThe legislative procedures of the European Union are the ways in which the European Union enacts legislation. The procedure used for any given legislative proposal depends on the policy area in question...
depending on their subject matter.
Legal basis
The legal basis for the enactment of regulations is article 249 of the Treaty establishing the European Community and, as such, regulations only apply within the European Community pillar of the European Union.
- Article 249
- In order to carry out their task and in accordance with the provisions of this Treaty, the European Parliament acting jointly with the Council, the Council and the Commission shall make regulations and issue directives, take decisions, make recommendations or deliver opinions.
- A regulation shall have general application. It shall be binding in its entirety and directly applicable in all Member States.
- A directive shall be binding, as to the result to be achieved, upon each Member State to which it is addressed, but shall leave to the national authorities the choice of form and methods.
- A decision shall be binding in its entirety upon those to whom it is addressed.
- Recommendations and opinions shall have no binding force.
The Council can delegate legislative authority to the Commission and, depending on the area and the appropriate legislative procedure,both institutions can make laws. There are Council regulations and Commission regulations. Article 249 does not clearly distinguish between legislative acts and administrative acts, as is normally done in national legal systems.
Legal effect
Regulations are in some sense equivalent to "Acts of Parliament", in the sense that what they say is law, and do not need to be mediated into national law by means of implementing measures. As such, regulations constitute one of the most powerful forms of European Union law and a great deal of care is required in their drafting and formulation.
When a regulation comes into force it overrides all national laws dealing with the same subject matter and subsequent national legislation must be consistent with and made in the light of the regulation. While member states are prohibited from obscuring the direct effect of regulations, it is common practice to pass legislation dealing with consequential matters arising from the coming into force of a regulation.
See also
- Directive (European Union)
- List of European Union regulations
:Category:European Union regulations
- Law of the European Union
- EUR-Lex
EUR-Lex is a service on the official website of the European Union, europa.eu. It provides legal texts of the union.EUR-Lex provides direct free access to European Union law. The system makes it possible to consult the Official Journal of the European Union and it includes inter alia the treaties,...
- EudraLex
EudraLex is the collection of rules and regulations governing medicinal products in the European Union.-Volumes:EudraLex consists of 10 volumes:*Concerning Medicinal Products for Human use:**Volume 1 - Pharmaceutical Legislation....
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