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Regulations General


Handling flammable, compressed, or cryogenic substances may be dangerous not only for the person doing it but also for others or the society as a whole. Industrialisation brought about not only much larger amounts of such substances used for processes of all kinds but also a more complex structure of the society which is more vulnerable from technical problems. This is why for the last two centuries more or less all countries (or their provinces or communities) issued legal requirements or regulations in order to guarantee a minimum level of safety for human life and health as well as for material values. The increasing safety demands of the modern citizen towards the society, new technologies (nuclear, genetic) as well as new threats (terrorism) cause an ever increasing refinement of those rules. This paragraph deals in particular with legal requirements applicable to hydrogen and the safety issues associated with it.

The purpose of the legal requirements discussed here is at first to prevent damage to persons working with dangerous substances. This does not primarily mean somebody who handles them privately for his own purposes. It is rather directed at somebody who handles something by order of his employer. Here the rules for dangerous substances in a commercial environment place the responsibility on the employer or the direct superior of the worker by demanding a certain level of technical equipment, education and information providing a reasonably safe process. Nonetheless any damage which might occur must not become so major that it affects the general public outside the working place or company. Another important field for legal requirements is the transport of dangerous substances. Persons involved not in the handling of the substance, but only in their transport (like truckers or railway workers) shall be protected from undesirable effects, and the same holds for the general public.

What is true in each individual country applies also to a body like the European Union. Neither the European Commission nor the European Council or the European Parliament, however, can simply sidestep the sovereignty of the member states in replacing their national regulations by others. Though there are European regulations (which require the consent of the European Parliament and the European Council), the man instrument for achieving a common ground in all countries are directives. They define a certain level which is compelling, but not immediately for the individual citizen. Directives are rather directed to the member countries which are obliged to adopt them in their national legislation within a reasonable time. In doing so the national legislation has a certain manoeuvring space, but only to one side; the minimum level given by the directive must be maintained.

Apart from the directives of the EU there are also other regulations from other sources. International transport of dangerous goods is dealt with in a number of international agreements which comprise ADR (road), RID (rail), IMO (sea) and ADNR (inland waterways). ADR and RID are also relevant as EU regulations because they are annexed by the Council Directives 94/55/EC and 96/49/EC, respectively. Air traffic is cared for by IATA and ICAO. For making sure that motor vehicles can be used internationally there are different provisions; one of them involves the UNECE.

European Legal Requirements

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 vehicles for discussion. The requirements of a European directive are brought into force by enacting national legislation in the EU member states, whereas a European regulation is effective without national implementing legislation.

There is, of course, no such thing as a European Hydrogen Directive. Apart from a few exceptions for very important or particularly dangerous substances regulations are usually not substance specific, but application specific. So the correct question is not: “Which regulations apply to hydrogen?”, but rather: “Which regulations apply to what I want to do with hydrogen, and to the environment where I intend to do it?”

It is possible to distinguish between the following Directive typologies under the EC Treaty:

  • Product Directives (art.95 of the EC Treaty)
    • they are addressed to the product manufacturer
    • they are based on the principle of the freedom of movement on the Community market
  • Social Directives (art.137 of the EC Treaty)
    • they are addressed to the employer
    • they fix the minimum safety, hygiene and health requirements at work (the Member States can adopt more binding national requirements)

Among the most important European directives applicable to hydrogen are those on pressure equipment. There are the Pressure Equipment Directive (PED) and separately the Transportable Pressure Equipment Directive (TPED). The latter is closely connected to international agreements on the transport of dangerous goods (ADR, RID, …).

Another important field of regulation when flammable gases are involved is the prevention of damage by explosions in case the gases are released unintentionally. This is mainly covered by the directives 94/9/EC (formerly ATEX 100) and 99/92/EC (formerly ATEX 118).

Prevention of major accidents and associated releases of harmful substances in the environment or the mitigation of the effects, respectively, is the subject of the Seveso II directive.

While these are the most important and specific ones there are numerous directives which might be applicable in a certain context or situation. The Machinery directive is an example for a document of very general character which applies to almost anything, including hydrogen technology.

The more important directives will be discussed below in detail.

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 former European Free Trade Association (now part of the EEA). 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.

The 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 ECs “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 requirements.

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
  • 2006/42/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

CE Marking

The CE marking is neither a mark of origin nor a quality mark. CE marking applies to the manufacturer who has to affix the marking to state the conformity with all applicable directives. In details CE marking shows that the product marked fulfills all applicable provisions (or requirements) of applicable directive(s) that provide for CE marking (essential requirements, harmonised standards and specific dispositions), and that the product has been subject to the appropriate conformity assessment procedure(s) contained in the directive(s).

The scope of the CE marking regime is laid down in the relevant harmonisation directive(s), and can only be apllied by the legal entity responsible for the conformity of the product.

The hydrogen system shall comply with the following directives in order to gain CE marking :

  • Machinery directive ; 98/37/EC,
  • Equipment and protective systems intended for use in Potentially Explosive Atmosphere ; 94/9/EC,
  • Pressure equipment directive ; 97/23/EC,
  • Low voltage directive ; 73/23/EEC,
  • Electromagnetic compatibility directive ; 89/336/EEC,
  • Simple pressure vessels directives ; 87/404/EEC , 90/448/EC.

The most relevant EC requirements are discussed in the next paragraphs.

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Page last modified on December 03, 2008, at 11:53 AM