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As shown in the figure above, the main difference between legal requirements (regulations and codes) and standards is their legal status. Regulations are made by political bodies (parliaments, governments); they are legally binding, and prescribe an acceptable level of, for example, safety or emissions for the technology in question. In contrast following standards is voluntary, but they are a useful instrument for the industrial organisations or interest groups dealing with the technology in question.


A standard as discussed in this report is a document, established by consensus and approved by a recognised body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context. An international standard is a standard developed and adopted by an international standardisation organisation and made available to the public (as defined in IEC/ISO Guide 2). The application of a standard is not obligatory, unless a regulation refers to that standard. Even then the legal power comes from the regulation, not from the standard.

Legal Requirements

A legal requirement (directive, regulation or code, etc.) is a national or European statutory text which is imposed by authority. It states requirements that are written and adopted by legislative bodies, so as to regulate a particular kind of activity. Legal requirements are intended to guarantee that a product or system or activity will not impact on the human safety / health or on the environment.

European regulation

European laws, such as Directives, Regulations, European rules prevail over national laws. In order to carry out their task and in accordance with the provisions of the Treaty establishing the European Community (the EC Treaty), the Parliament acting jointly with the Council, the Council and the Commission make regulations and issue directives.

	European Directive (art. 189 of the EC Treaty)

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 (national transcription).

	Regulation (art. 189 of the EC Treaty) 

A regulation shall have general application. It shall be binding in its entirety and directly applicable in all Member States. The EU has for example submitted a first draft of a regulation for the type approval of hydrogen cars for discussion.

International Road Vehicle Regulations

To facilitate global commerce in road vehicles it has long been recognised that there is a necessity to harmonise regulatory requirements across the major markets. These activities were initially undertaken on a European level by WP.29 a subsidiary body of the United Nations, Economic Commission for Europe, Inland Transport Committee, but that role has now expanded to a global one. WP.29 was originally titled Working Party on the Construction Vehicles but latterly has been renamed World Forum for Harmonisation of Vehicle Regulations.

	UNECE Regulation (1958 Agreement)  

In the framework of the United Nations' Economic Commission for Europe (UNECE) in Geneva, and for mobile applications, WP.29 and its subsidiary bodies are developing Regulations under the 1958 Agreement in cooperation with all Contracting Parties to the Agreement and non-governmental organizations (NGOs). The 1958 Agreement is entitled “Agreement concerning the adoption of uniform technical prescriptions for wheeled vehicles, equipment and parts which can be fitted and/or be used on wheeled vehicles and the conditions for reciprocal recognition of approvals granted on the basis of these prescriptions.” UNECE Regulations are not applicable on a mandatory basis to all Contracting Parties to the 1958 Agreement, but if a Contracting Party decides to apply a UNECE Regulation, the adoption becomes a binding act. A contracting party that has adopted a Regulation under the 1958 Agreement is allowed to grant type approvals pursuant to that Regulation and is required to accept the type approval of any other contracting party that has adopted the same Regulation. European and some non-European countries, require an authority together with a technical service undertaking approval testing, to assess compliance of components and the vehicle with the legal requirements. The process is known as type approval. In contrast North America uses the self-certification process. The 1958 Agreement was revised in 1995 (Revision 2) to promote the participation of non-European countries and became a global agreement. The United States did not adhere to this Agreement. Members of the 1958 agreement are: GERMANY, FRANCE, ITALY, NETHERLANDS, SWEDEN, BELGIUM, HUNGARY, CZECH REPUBLIC, SPAIN, YUGOSLAVIA, UNITED KINGDOM, AUSTRIA, LUXEMBOURG, SWITZERLAND, NORWAY, FINLAND, DENMARK, ROMANIA, POLAND, PORTUGAL, RUSSIAN FEDERATION, GREECE, IRELAND, CROATIA, SLOVENIA, SLOVAKIA, BELARUS, ESTONIA, BOSNIA AND HERZEGOVINA, LATVIA, BULGARIA, TURKEY , THE FORMER YUGOSLAV REPUBLIC OF MACEDONIA, EUROPEAN COMMUNITY, JAPAN, AUSTRALIA, UKRAINE, and the REPUBLIC OF SOUTH AFRICA.

For instance, under the 1958 agreement, the Regulation 110 is related to the “uniform provisions concerning the approval of: I. specific components of motor vehicles using compressed natural gas (NG) in their propulsion system ; II. vehicles with regard to the installation of specific components of an approved type for the use of compressed natural gas (CNG) in their propulsion system.” is an example of UNECE Regulation.”

 UN ECE 1998 Agreement (Global Technical Regulation)

Global Technical Regulations (GTR) apply to road vehicles. GTR contain technical requirements and are established under the 1998 Agreement ("Agreement concerning the establishing of global technical regulations for wheeled vehicles, equipment and parts which can be fitted and/or be used on wheeled vehicles", done at Geneva on 25 June 1998). GTR are different from the EU Directives and UN ECE regulations because they do not call for mutual recognition of type approvals or certifications; they permit existing approval procedures to be utilized by harmonizing only the technical requirements. The 1998 Agreement allows all regions of the world to participate in the development of GTRs for vehicles and their components. Canada, China, EC, France, Germany, Italy, Japan, Korea, the Russian Federation, South Africa, Spain, the UK and the USA are included in the contracting parties to this Agreement.


In legally terms, a code is a collection of rules, requirements or standards that have been made binding and mandatory by a local or national government (as defined in the ISO / TR 15916). In practical use of language the term code often refers to a North American document. In this report, we distinguish “code” (with compelling power) and “code of practice” (which is a voluntary instrument – see paragraph Code of practice).

New Approach Directives and Harmonised Standards

The European Union introduced a series of measures to ensure the free movement of goods throughout the European Union (EU) and the European Free Trade Area (EFTA). New Approach Directives are one of these measures. These Directives aim at controlling product design and above all, at ensuring technical harmonisation of product safety requirements across Europe, so as to guarantee a high level of protection to the public. New Approach has been laid down by the Council Resolution of 1985. European harmonised standard provides the detailed technical information enabling manufacturers to meet the essential requirements. "Harmonised Standard" has a specific meaning in the context of the EC's “New Approach” to regulation : • that is in support of one or more Directives, • that has been produced by CEN or CENELEC, • when the reference has been published in the Official Journal of the EC (OJ), • and that has been published by at least one national standards body. A harmonised standard provides a presumption of conformity with the essential requirements covered by the standard. These standards - produced under a mandate from Member States through the Commission - give the technical measures to meet the essential. The Guide to the implementation of directives based on the New Approach and the Global Approach defines essential requirements as follows: • Essential requirements lay down the necessary elements for protecting the public interest. • Essential requirements are mandatory. Only products complying with essential requirements may be placed in the market and put into service. • Essential requirements must be applied as a function of the hazards inherent to a given product.

The New Approach Directives also explain to the manufacturers how to demonstrate conformity with the essential requirements. Products which meet the essential requirements are to display the CE marking, as described in the particular directive. CE marking means that the product can be sold anywhere in the Community/EEA . When a product bears a CE marking, it means that: • It complies with all applicable Directives, • It can move freely in any member state.

Application of harmonised standards or other technical specifications remains voluntary, and manufacturers are free to choose any technical solution that provides compliance with the essential requirements. (Source Guide to the Implementation of Directives Based on New Approach and Global Approach – European Commission).

The following Council Directives are based on the New Approach principles: • 73/23/EEC of 19 February 1973 on the harmonization of the laws of Member States relating to electrical equipment designed for use within certain voltage limits • 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility • 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment • 98/37/EC of the European Parliament and of the Council of 22 June 1998 on the approximation of the laws of the Member States relating to machinery


Code of practice

Codes of practice are usually a set of best practices for a specific product or system so as to ensure safe handling, maintenance and operation.


A guideline or a guide is a document generally written for a given organisation, whether for its own needs, or for its customers’ needs. Guidelines provide guidance to appropriate behaviour so as to ensure safety of people (workers, users and general public). It may also give information about codes, standards and regulations to comply with and about the recommended way to meet those requirements. For example, it gives information related to material properties, adequate installation, and use of equipment and safety procedures. Guidelines may be intended: • to authorities, who have to verify the conformity with applicable regulations and standards of a system and to approve it, • to end-users of a given system, so that they can run the system in accordance with safety and performance requirements, • to maintenance employers, so as to give them principles to observe during maintenance and cleaning up.

State of the art

State of the art is the most advance technique or method used at a given time.

Best engineering practices

Best engineering practices means the best practices performed in the design, construction, or operation of structures, machines, or other devices of industry and everyday life. Best engineering practices are defined from the industrial organisations and key implementers of a given technology.

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Page last modified on February 27, 2007, at 02:04 PM