There are two important and fundamental points about the nature of EU law to grasp at the outset.
Firstly, EU law reigns supreme throughout the EU. The principle of primacy of EU law means that any law of a Member State which conflicts with valid EU law must be disapplied in the national courts regardless of whether the national law was passed before or after the EU law with which it conflicts.1 Law which stems from the EU treaties, which provide an independent source of law, cannot be overridden by national law without being deprived of its character as EU law and without the legal basis of the EU itself being called into question.
Secondly, the subjects of EU law include not just the Member States but also citizens and other legal persons. If a provision of EU law is clear and unconditional it has direct effect and may be relied on by a person in proceedings before a national court.2 Where a provision does not have direct effect national law, whether coming into force before or after relevant EU law, must be interpreted consistently and give effect to EU law.3
The concepts of ‘direct applicability’ and ‘direct effect’ are not the same. A measure of EU law is 'directly applicable' if it is incorporated into the national law of a Member State without the need for further legislation in the Member State and is an institutional concept. On the other hand, 'direct effect' is a remedial concept which makes some provisions of EU law enforceable and which can be relied on by individuals in a national court and has developed through EU case law. It is now established that some provisions of EU law are directly effective but not directly applicable, some are directly applicable but not directly effective, and some are both directly effective and directly applicable.
The responsibility for making EU law is divided between:
The European Parliament.
The Council of the European Union.
The European Commission.
These institutions make policy and law which apply throughout the EU using the ordinary legislative procedure. In principle, the European Commission proposes new laws, and the European Parliament and the Council of the EU adopt them. The Commission and member countries then implement them, and the Commission ensures that the laws are properly applied and implemented.
The legislative process in the EU is described on the official website decision-making in the European Union for those who seek more detail of the process is not required for present purposes. The description offered here is more concerned with the outcome rather than the process, in particular the status of different outcomes of the legislative process, how they take effect in the United Kingdom and, more particularly, in England.
All the EU legislation in force at the time of the United Kingdom’s accession to the Treaty of Rome in 1973 was incorporated into domestic law. Under the terms of the European Communities Act 1972 a designated Minister has power to secure the compliance of domestic law with EU obligations by means of delegated legislation including orders, rules, regulations or other subordinate instrument.4 Most of what the food producer has to contend with today derives from Regulation 178/2002.
The aims and objectives established in the EU treaties (sources of primary EU law) are achieved by several types of legal act or secondary EU legislation for which provision is made under Article 288 of the Treaty on the Functioning of the European Union:
To exercise the Union’s competences, the institutions shall adopt regulations, directives, decisions, recommendations and opinions.
Some of these acts are binding, others are not. Some apply to all EU countries, others to just a few.
The authority for EU food law derives from three articles:
Article 43 in relation to matters falling within the common agricultural policy.
Article 114 in relation to internal market matters.
Article 168(4)(b) in relation to “veterinary and phytosanitary5 fields which have as their direct objective the protection of public health”.
The recitals at the start of each regulation, directive or decision are important to the interpretation to be given to the act and should not be overlooked. The Court of Justice of the European Union will take these into account if called upon to interpret an act.
The use of regulations is now the favoured means by which EU food law is being developed.
A regulation is a binding legislative act and must be applied in its entirety across the EU. A regulation is directly applicable in all Member States, meaning that it is a part of national domestic law without the need for any specific incorporation. A Member State has no power to apply regulations incompletely or to apply only those provisions of which it approves.
A regulation is directly applicable in civil proceedings between individuals.6
The provisions of a regulation may also have direct effect and confer rights on individuals.
Both direct applicability and direct effect have the force of law in the UK by virtue of section 2(1) of the European Communities Act 1972. Whilst regulations may be directly applicable most need to be supplemented by national secondary legislation which puts in place sanctions for non-compliance with obligations imposed by a regulation.
A directive is a legislative act which is binding as to the result which is to be achieved by all EU countries. It is, from the perspective of the Member States, a more flexible route since it is up to individual countries to decide how and by what means it is to be implemented and the desired result achieved.
A directive may also have direct effect and would normally contain a time limit within which Member States must implement the directive.
Directives continue to be used for enacting rules on general labelling and advertising, particular foodstuffs, food supplements and additives.
A decision is binding on those to whom it is addressed and is directly applicable. A decision may be addressed to an individual, company or other legal person or a Member State. In keeping with a directive, a decision can have direct effect and require implementation.
Decisions are used for the imposition of import conditions, the authorisation of novel foods and emergency measures.
A recommendation is not binding. A recommendation allows the institutions to make their views known and to suggest a line of action without imposing any legal obligation on those to whom it is addressed. A national court may have to take a recommendation into account where it may help clarify the interpretation of EU or national law.
An opinion is an instrument that allows the institutions to make a statement in a non-binding fashion, in other words without imposing any legal obligation on those to whom it is addressed. An opinion is not binding but, as with a recommendation, may need to be taken into account.
2 NV Algemene Transport en Expeditie Onderneming Van Gend en Loos v Nederlandse Administratie der Belastingen (Case 26/62)  ECR 1
3 Von Colson and Kamann v Land Nordrhein-Westfalen (Case 14/83)  ECR 1891
5 The inspection intended to prevent the spread and the introduction across national boundaries of pests of plants and plant products.