Modern Harmonisation Approach

Common Market to Single Market

The first and central objective of the European Union, originally the European Economic Community was the common market. The expression “internal market” replaced the expression “common market” after the Single European Act.  The Single European Act sought to introduce an area without frontiers in which there was free movement of goods, persons, services and capital.

The Single European Act was one of the first major amendments to the treaties.  It was introduced in the 1980s with a view to completing the internal market by 31st December 1992.  It contemplated more than 300 measures designed to remove most of the remaining barriers to trade.

New Approach to Harmonisation

The prior approach to harmonisation was found to be unsatisfactory.  The new approach involved setting out the essential requirements for common standards, typically safety requirements or other key product standards, together with procedures for certification of compliance.

The CE mark is employed as the marker of standards compliance.  Goods which comply with the essential technical standards, and are assessed and attested in accordance with the terms or procedures in the relevant directives, must be allowed to circulate freely within the European Union.  States can no longer prohibit such goods on the basis of noncompliance with national technical standards.

The new approach was found to be successful and has been later enhanced.  European decisions and directives in the mid-1990s provided for mechanisms to prevent new technical buyers emerging in trade within the EU.  States are obliged to send their technical regulations to the Commission and to other states to vouch for conformity with the European Union law.  There is a right to impose a standstill.  Failure to notify may make the national measure unenforceable.

A number of European standardisation bodies coordinate standardisation work with the national bodies, in particular, the European Committee on Standardisation, European Committee on Electro-technical Standardisation and the European Telecommunications Standards Institute.

EU Standards I

European Union standards has eclipsed national standards to a large extent.  EU Directives in certain sectors define product safety and requirements. A range of products including motor vehicles and its components, machinery, construction products and electrical equipment and many others are subject to specific Directives making the standards legally enforceable.

The modern approach to European Union product standard harmonisation involves a focus on the essential health and safety requirements.  They are set out in the relevant Directive where the standard has the force of law. The standards define compliance for the purpose of free movement and sale of the product in the European single market.

The standards have been developed by European standards bodies and are generally known as European norm.  The principal European standards bodies are  CEN and  CENELEC. There are over 10,000 European norms.  Where they apply, they displace national norms.

There are various types of EU standards.  A standard may cover all aspects applicable to the product, equipment or machinery ranging from design, risk and manufacture processes to the composition and specification. For example, the requirements in relation to machinery, cover particular safety and ergonomic aspects of machinery as well as the safety of components and ancillary devices.  These standards cover groups and types of machines.

New standards must be notified to the EU Commission before they are used.  States must notify draft technical standards in advance of adaptation at the national level.  This is to assist the Commission in considering whether  European standards are appropriate.

EU Standards II

Many European norms reflect ISO, the International Organization for Standardisation, norms.  The International Standard Organisation is a body under the auspices of the United Nations.  It seeks to create global standards.

Various other bodies have developed international standards in particular spheres  These may also be the basis of EU, European norms and ISO norms. See the articles on the modern EU approach to standardisation.

In most cases, producers self-certify compliance under the auspices of an approved bodies or the national agency, which in Ireland is the National Standards Authority of Ireland.  Some classes of product and equipment require independent external certification and checking where. The NSAI has approved bodies various bodies in particular sectors for this purpose.

The focus of the modern EU approach is on the essential safety and health requirements of products.  These are listed in the Directives and updated from time to time.

There is are a much wider range of products, processes, and services which are the subject of European standards than those which are embodied in legislation or legal requirements as such.

The Directive in relation to machinery covers a wide range of equipment and more complex plant and equipment.   Manufacturers and suppliers of machinery must ensure that machinery is safe and complies with the essential health and safety requirements in the Directive.  A technical file must be prepared for the machinery and retained.

If a machinery is of the type identified in the Directive as carrying particular hazards, it must be submitted to the National Standards Authority for type examination. More dangerous equipment and equipment posing particular risks must be specifically type examined.

If the product is manufactured in accordance with harmonised standards, the instructions filed must be verified by the domestic authority. There must be a declaration of conformity in respect of the machinery to confirm compliance with the standard together with the CE marking.

Single Market Supported by Other Treaty Principles

The free movement of goods is based on the fundamental principles in the treaty.  The most basic prohibitions were the elimination of customs duty and charges having an equivalent effect.  Restrictions and quotas were to be eliminated with very limited exceptions.

State subsidies are prohibited unless authorised by the Commission on the objectively justifiable basis.  Discrimination in procurement by national bodies is prohibited.  All providers within the EU are entitled to tender to undertake major public works and services contract.

Free movement of capital was achieved, as in 1992.  All exchange controls were abolished in mid-1992.  The Euro was introduced between most member states.  All new member states after 2004 are obliged to adopt the euro once they satisfy their own convergence criteria.

Competition rules seek to ensure that states do not directly or indirectly subsidise their own entities in such a way as to distort competition.  The broad principles of competition law apply to trade in goods and services.  The abuse of a dominant position or the restriction of trade without objectively justifiable reasons is prohibited and non-enforceable.

The basic freedoms are applied to three of the four European Free Trade Agreement countries, Iceland, Norway, and Liechtenstein under the EEA/ EU agreements. Switzerland enjoys a similar arrangement under numerous bilateral arrangements.

The key elements of the internal market include the common commercial policy, common agricultural, common transport and common fishery policies.

There are rules against discriminatory taxation.  There is a common system of value added tax which is the basic sales tax throughout the Union.  There is a common external customs tariff.

The common commercial policy provides for participation by the EU in the World Trade Organisation on behalf of all member states.

Non-Harmonised Areas

Under the principle of mutual recognition recognised in EU case law products lawfully marketed in
one EU State can be marketed in all other EU (incl EEA) States, even if the product does not fully comply with the technical rules of the importing EU (EEA) State. An importing EU State may exceptionally preevent a product from being placed on its market if justified. T

This means that in non-harmonised areas, all EU States may have national technical regulations and requirements. However, an EU State may only refuse the marketing of a product lawfully placed on the market in another EEA State if it can demonstrate that it is strictly necessary for the protection of, for example, public safety, health or the environment. The importing EU State must also demonstrate that the measure is proportionate and that it does not discriminate.

When an EU Member State plans to regulate a given product area, it has to notify the European Commission in advance. The European Commission can then assess the draft national regulation to
determine whether it conforms to the basic principles of the Internal Market.

Mutual Recognition Agreements

The EU has concluded a number of Mutual Recognition Agreements  with non-EU countries
in which it grants Conformity Assessment Bodies from these countries the right to certify products for the European market.

The EU’s neighbouring countries are increasingly adopting the EU regulatory system and EU
harmonised legislation. The EU-Turkey Customs Union ensures the free movement of products based on harmonised legislation.

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