The scope of the Directive


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Article 1 defines the meaning given by the Directive to a number of key terms, used throughout its provisions. This terminological and semantic clarification is essential to an efiective understanding of the text and simultaneously defines the scope of the Directive.

The scope of the Directive

Article 1

For the purposes of this Directive, the following meanings shall apply:

1) ‘product’, any industrially manufactured product and any agricultural product, including fish products;

The scope of the initial version of the Directive (i.e. 83/189/EEC) excluded cosmetic products within the terms of Directive 76/ 768/EEC15, medicinal products within the terms of Directive 65/ 65/EEC16, products destined for human and animal consumption and agricultural products.17The scope of the Directive has been extended, since the operation of the information procedure revealed that numerous national regulations and standards involving barriers to intra-Community trade had not been monitored by the Commission and the Member States because certain products were not covered.

In order to clarify the very broad definition which is now used, it is worth recalling that the Court of Justice included in the framework of the provisions relating to the free movement of goods under Article 28 of the Treaty, ‘products which can be valued in monetary terms and which may, as such, form the subject of commercial transactions’.18 In this context, the Court also ruled that waste, whether recyclable or not, is to be considered to be a product whose movement should not, in principle, be prevented.19It is appropriate to take this into consideration in determining the scope of the Directive.

2) ‘service’, any Information Society service, that is to say, any service normally provided for remuneration, at a distance, by electronic means and at the individual request of a recipient of services 20 .

For the purposes of this definition:

- ‘at a distance’ means that the service is provided without the parties being simultaneously present,

- ‘by electronic means’ means that the service is sent initially and received at its destination by means of electronic equipment for

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the processing (including digital compression) and storage of data, and entirely transmitted, conveyed and received by wire, by radio, by optical means or by other electromagnetic means,

- ‘at the individual request of a recipient of services’ means that the service is provided through the transmission of data on individual request.

An indicative list of services not covered by this definition is set out in Annex V.

This Directive shall not apply to:

- radio broadcasting services,

- television broadcasting services covered by point (a) of Article 1 of Directive 89/552/EEC.

It should be emphasised that the inclusion of Information Society Services constitutes a very important extension of the scope of the Directive which has brought it in line with new developments in international commerce. To determine whether an activity comes within the definition of Information Society services, it is first necessary to verify whether the activity in question constitutes a ‘service’ in accordance with Community law.

According to the case-law of the Court of Justice, ‘services’ means a service provided normally for remuneration. The Court of Justice has stipulated that the ‘essential characteristic of remuneration […] lies in the fact that it constitutes consideration for the service in question’.21Such a characteristic is lacking in the activities the State undertakes without consideration with- in the framework of its tasks, particularly in social, cultural, educational and legal areas.

Next, it is necessary to verify whether the service is, in the terms of the Directive, an ‘Information Society service’. In accordance with Article 1(2) of the Directive, Information Society service means a service provided: ‘at a distance’, ‘by electronic means’ and ‘at the individual request of a recipient of services’.

The concept of ‘at a distance’ concerns situations in which the service is provided using distance communication techniques, which are therefore characterised by the fact that the parties

(i.e. the service provider and the recipient) are not physically and simultaneously present.

The expression ‘by electronic means’ means services whose constituent elements are transmitted, conveyed and received within an electronic network. The service must be conveyed from its point of departure to its point of arrival by means of electronic (processing and storage) equipment and by telecommunications means.

Finally, the service must be provided via the transmission of data at an individual request. This constitutes the element of interactivity which characterises Information Society services and sets them apart from other services that are sent without a request from the recipient being necessary. For this reason, Article 1 specifies that the Directive does not apply to radio broadcasting services or to television broadcasting services covered by Directive 89/552/EEC22(as amended by Directive 97/36/EC23, the ‘Television without Frontiers’ Directive)24.

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Examples of services covered by the Directive are general online information services (newspapers, databases etc.), distance monitoring activities, interactive teleshopping, electronic mail, online fiight reservations, online professional services (access to databases, diagnostics etc.).

3) ‘technical specification’, a specification contained in a document which lays down the characteristics required of a product such as levels of quality, performance, safety or dimensions, including the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures.

The term ‘technical specification’ also covers production methods and processes used in respect of agricultural products as referred to in Article 38 (1) of the Treaty, products intended for human and animal consumption, and medicinal products as defined in Article 1 of Directive 65/65/EEC, as well as production methods and processes relating to other products, where these have an efiect on their characteristics;

This provision defines the concept of technical specification, a generic term which covers standards as well as technical regulations.

It stipulates that the document containing the technical specification defines ‘the characteristics required of a product’. The examples given are not exhaustive; the composition of the product, its shape, weight, presentation, performance, life span, energy consumption, etc., could have been added.

The specification can serve a multitude of goals: for example, protection of the consumer, of the environment, public health or safety, standardisation of production, improvement of quality, fairness of commercial transactions, maintenance of public order.

The initial version of the Directive limited the definition of technical specification to the characteristics required of the product. The broadening of the concept of technical specification to include production processes and methods was carried out in two stages: firstly in 1988 (by Directive 88/182/EEC) with regard to agricultural products, products for human and animal consumption and medicinal products, at the time of their inclusion in the scope of the Directive; secondly in 1994 (by Directive 94/10/EC) with regard to other products, for the sake of consistency.

In the field of agriculture, products for human and animal consumption and medicinal products, production methods and processes generally afiect the product itself (for example, the obligation to vaccinate cows before selling them). This is not always the case in the other product sectors, and here the Directive makes impact on the product a condition for notification of the production methods and processes concerned, with the specific exclusion of regulations relating to the organisation of work, which does not afiect products.

Testing and test methods, quoted as examples of technical specifications, cover the technical and scientific methods to be used to evaluate the characteristics of a given product. The conformity assessment procedures, which are also mentioned, are those used to ensure that the product conforms with specific requirements. They are the responsibility of specialist bodies, whether public or private, or of the manufacturer.

The inclusion of these parameters within the scope of the Directive is of the utmost importance, because testing and conformity assessment procedures can, under certain conditions, have negative efiects on trade. The multiplicity and disparity of the national systems of conformity certification can cause technical barriers to trade in the same way as the specifications applicable to the products, which are even more dificult to overcome as a result of their complexity.

4) ‘other requirement’, a requirement, other than a technical spec-ification, imposed on a product for the purpose of protecting, in particular, consumers or the environment, and which afiects its

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life cycle after it has been placed on the market, such as conditions of use, recycling, reuse or disposal, where such conditions can significantly infiuence the composition or nature of the product or its marketing;

The concept of ‘other requirement’, as defined by this paragraph, did not exist in the initial version of Directive 83/189/ EEC. It was introduced by Directive 94/10/EC, at the time of the second amendment of the text.

This term covers requirements which can be imposed on a product during its life cycle, from the period of use through to the phase of management or disposal of the waste generated by it.

The provision specifies that this type of requirement is principally imposed for the purpose of protecting consumers or the environment. These are two of the grounds of major needs which could, in exceptional circumstances, justify a Member State departing from the principle of the free movement of goods by imposing trading bans or restrictions.

The ‘conditions of use, recycling, reuse or disposal of a product’, quoted as examples of ‘other requirements’, refer to the most important specific cases. In order to qualify as ‘other requirements’, these conditions must be likely to have a significant effect on the composition, the nature or the marketing of the product. A decree relating to the management of medicinal waste or a national regulation seeking to impose a return or reuse system for packaging, or even the separate collection of certain products, such as discharged batteries, can therefore be expected to contain provisions which fall into the category of ‘other requirements’.

5) ‘rule on services’, requirement of a general nature relating to the taking-up and pursuit of service activities within the meaning of point 2, in particular provisions concerning the service provider, the services and the recipient of services, excluding any rules which are not specifically aimed at the services defined in that point.

Examples of measures likely to constitute a rule on Information Society services include measures concerning the conditions for taking up an activity (e.g. obligation to obtain a licence); measures relating to the conditions for pursuing an on-line activity (e.g. general ban on commercial promotion or certain forms of advertising); measures concerning the provider of online services (e.g. requirements relating to professional experience required to be an on-line tax consultant); measures concerning the supply of on-line services (e.g. laws laying down the maximum fees which may be charged) and measures related to the recipient of such services (e.g. participation limited to certain age group, measures applying to specific categories of recipients, such as minors).

This Directive shall not apply to rules relating to matters which are covered by Community legislation in the field of telecommunications services, as defined by Directive 90/387/EEC 25 .

Directive 90/387/EEC defines telecommunications services as ‘services whose provision consists wholly or partly in the transmission and routing of signals on a telecommunications network by means of telecommunications processes, with the exception of radio broadcasting and television’.

The reason for this specific exemption is that in the field of telecommunications services (as in financial services, see following section) a large number of matters are already harmonised

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and are part of an already existing and suficiently defined Community regulatory framework.

This Directive shall not apply to rules relating to matters which are covered by Community legislation in the field of financial services, as listed non-exhaustively in Annex VI to this Directive.

The reason for such an exemption from the scope of the Directive is identical and is due to the fact that such rules are part of an already suficiently established Community legal framework.

Purely as a guide, a non-exhaustive list of financial services is supplied in Annex VI to Directive 98/48/EC.

With the exception of Article 8(3), this Directive shall not apply to rules enacted by or for regulated markets within the meaning of Directive 93/22/EEC or by or for other markets or bodies carrying out clearing or settlement functions for those markets.

Directive 93/22/EEC of 10 May 1993 regulates investment services in the securities field.26As a result of this exemption, the rules drawn up by or concerning regulated markets or other markets or bodies carrying out clearing or settlement operations for such markets are not subject to the obligation of prior notification. The only obligation to which such rules, in the interests of minimal transparency, are subject is that of ‘ex-post’ notification, i.e. they should be communicated to the Commission after adoption at national level pursuant to Article 8(3), which - as indicated by the fourth subparagraph of Article 1, point 5 - is the only provision in the Directive which applies to these rules.

For the purposes of this definition:

- a rule shall be considered to be specifically aimed at Information Society services where, having regard to its statement of reasons and its operative part, the specific aim and object of all or some of its individual provisions is to regulate such services in an explicit and targeted manner,

- a rule shall not be considered to be specifically aimed at Information Society services if it afiects such services only in an implicit or incidental manner.

It is extremely important to emphasise that the obligation to notify in advance does not apply to all draft national regulations which - directly or indirectly, explicitly or implicitly - may concern Information Society services. Only a limited number and a well-defined category of draft national regulations will, for the purposes of the Directive, have to be notified in advance, namely the regulations specifically aimed at Information Society services. All other regulations afiecting services are not notifiable.

In view of the above, one should point out that the Directive requires the notification of regulatory drafts whose justification, content or purpose indicate that they are directly and openly devoted, in whole or in part, to controlling Information Society services. The provision(s) in a national regulatory instrument must be expressly drafted or in any event specifically designed to refiect the fact that the activity/service is supplied ‘at a distance, by electronic means and at the individual request of a recipient of services’.

Another point which should be emphasized is that it is not solely regulatory instruments which as a whole are devoted to Information Society services (e.g. a law on electronic signatures) that must be notified. Regulations of which only a part

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(possibly an article or even a paragraph) specifically concerns an Information Society service (e.g. within a law on pornography, a specific provision on the liability of an Internet access supplier) must also be notified.

On the other hand, the following draft regulations need not be notified: those which relate only indirectly, implicitly or incidentally to Information Society services, i.e. which concern an economic activity in general without taking into consideration the typical technical procedures for supplying the Information Society services (e.g. a provision which prohibits the distribution of paedophile material by any means of transmission, including the Internet or electronic mail, among the various possible means of dissemination).

6) ‘standard’, a technical specification approved by a recognised standardisation body for repeated or continuous application, with which compliance is not compulsory and which is one of the following:

- international standard: a standard adopted by an international standardisation organisation and made available to the public,

- European standard: a standard adopted by a European stand-ardisation body and made available to the public,

- national standard: a standard adopted by a national standard-isation body and made available to the public.

This paragraph defines one of the two fundamental concepts of the Directive.

It enables a distinction to be made between the concept of ‘standard’ and that of ‘technical regulation’, defined in Paragraph (11).

In order to be given the status of a standard, a technical specification must, under the terms of the Directive, meet four criteria:

1. It is ‘approved by a recognised standardisation body’

The body in question, whether it be national (such as AFNOR27in

France, DIN28 in Germany and BSI29 in the United Kingdom), European (CEN,30CENELEC31 or ETSI32), or international (ISO,33or IEC34), must be recognised as such, either by the public authorities by means of approval, a legislative or statutory text, or by the economic operators themselves, whether formally or informally.

The approval of a standard by such a body takes place by a voting procedure which brings the period of public enquiry to an end which enables comments to be obtained from the economic and social operators (industry, consumers’ associations, environmental organisations, etc.).

2. It is destined for ‘repeated or continuous application’

This criterion indicates that the standard is intended to be applied to products in general, in other words products normally encountered on the market, as opposed to products which have

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specific technical characteristics when compared to products routinely and lawfully marketed. This specific feature constitutes the fundamental difierence between a standard and a procurement specification, whether public or private. A standard can be used as a reference in numerous contracts - this is in fact one of its functions - but the specific conditions which the purchaser may wish to have applied to the product (the procurement specifications) will appear, in the call for tender, as requirements in addition to the criteria laid down by the standard.

The concept of continuity in the application of the standard refers to the need to adapt this document to technical progress, which it generally refiects. The appearance of new products and new techniques, more or less continuously - particularly in the area of information technology - creates an increasingly urgent demand for standards from economic operators, who require reference documents in order to organise the market as rationally as possible and ensure the economic success of these products and techniques.

The continuous application of the standard also assumes that the existing standards are constantly updated. A standard which has become obsolete will therefore be cancelled and replaced by a new one, which will take the latest technological advances into account.

3. Compliance with which is not compulsory

The voluntary nature of a standard distinguishes it from a technical regulation, application of which is mandatory. It stems from the principles and from the methods of preparation of a document which is the result of the initiative, voluntary participation and consensus between all the parties concerned: industrialists, scientists, consumer associations, environmental organisations, professional trade associations, etc.

4. It must be made available to the public

This last criterion appears obvious for a document whose application depends on the will of those who wish to use it. It is, nevertheless, important, because it implies that the public must be made aware of the existence of a standard and that its text should be readily accessible. Consequently, the standardisation bodies, whether national, European or international, publish their standards and sell them to the public. They are linked by distribution agreements which enable them to meet the request of anyone wishing to obtain a standard - whether national, European or international - from the body situated in their own country.

This definition of a standard difiers slightly from that of the International Standards Organisation (ISO)35 or the United Nations Economic Commission for Europe (UN/ECE), which place more emphasis on the economic role of the standard and the fact that it is the result of a consensus which serves the interests of the majority and is constantly adapted to scientific and technological progress.36The difierence stems from the fact that Directive 98/34/EC, following the 1995 WTO Agreement on technical barriers to trade, views standards solely from the viewpoint of combating technical barriers to trade.

The Directive bases its definition on a geographical typology of standards, which categorises three types of standard according to the scale on which the issuing organisation works: international standards, European standards and national standards. There are links between these three levels: an international standard can be adopted as a European standard, and a European standard must be adopted as a national standard by the national standardisation bodies. An international standard, on

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the other hand, will not necessarily be substituted for a national standard on the same subject.

7) ‘standards programme’, a work programme of a recognised standardisation body listing the subjects on which standardisation work is being carried out;

This paragraph defines the general framework within which all the standardisation bodies, whether they be national, European or international, plan their work within their own structures, during the crucial phase between the definition of the need for a standard and the preparation of a draft for public enquiry.

At a national level, these programmes are prepared in close collaboration with experts from the economic sectors which are most interested in the preparation of a standard. At the European and international levels, this co-operation takes place between representatives of the various members of these organisations.

The standards programmes of the national standardisation bodies are sent, on request, to the European Commission.

8) ‘draft standard’, document containing the text of the technical specifications concerning a given subject, which is being considered for adoption in accordance with the national standards procedure, as that document stands after the preparatory work and as circulated for public comment or scrutiny;

This paragraph defines the exact meaning of ‘draft standard’; it is not merely an intention to begin the work of standardisation but a very specific stage in the process of preparing the standard, that of public enquiry, the last stage before final adoption of the document.

At this stage, the standard has still not been approved but it contains all the envisaged technical specifications, which makes it easier to identify potential barriers to trade.

9) ‘European standardisation body’, a body referred to in Annex I.

There are three European standardisation bodies, listed in Annex I to the Directive: CEN (European Committee for Standardisation), CENELEC (European Committee for Electrotechnical Standardisation) and ETSI (European Telecommunications Standards Institute).37These bodies prepare European standards in specific sectors of activity and the three of them together make up the European standardisation system. They function in an autonomous but coordinated manner.

Most standards are prepared at the request of industry. The Commission can also request these bodies to prepare standards in the context of the implementation of Community legislation or in the context of an European policy. Such requests are known as mandates from the Commission. If these standards are prepared in the framework of the ‘New Approach’ directives, they are known as ‘harmonised standards’ and products manufactured in accordance with these standards benefit from a presumption of conformity with the essential requirements of a given directive. Such directives were adopted for several sectors such as electro-medical equipment, equipment used in explosive atmospheres, machine safety, electromagnetic compatibility. This ‘New Approach’ to technical harmonisation meant that the work leading to the approximation of national laws was speeded up considerably compared to traditional European directives which were characterized by a high degree of technical detail.38

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CEN (European Committee for Standardization) is a multi-sectorial standardisation body covering all sectors except electro-technical (CENELEC) and telecommunications (ETSI). CEN’s business domains are mechanical engineering, construction and civil engineering, health, biotechnology, the environment, safety at work, gas, transport, packaging, consumer goods, sport and leisure, the food industry, materials, the chemical industry, aerospace, services, quality, testing and certification, nanotechnology and many more.

CEN is an international association governed by Belgian law, whose headquarters have been in Brussels since 1975.

Since January 2004, CEN has had 28 full members - the national standardisation bodies of the 25 Member States of the Union and of the Member States of EFTA, with the exception of Liechtenstein, which does not have a standardisation body.39CEN also has afiliates, these being the standardisation bodies of Turkey and countries of South-Eastern Europe40, countries which, for the most part, are already linked to the Union by an associate membership agreement with the prospect of accession, or which are in the process of becoming so.

Since June 1992, CEN has enlarged its circle to include ‘associate members’, organisations representing economic and social interests on a European level, which may take part in preparatory discussions and in the decisions taken by the bodies responsible for administering standards’ programmes.41Through a cooperation agreement with the International Organization for Standardization (ISO), the so-called Vienna Agreement, European and international standards can be developed in common to avoid duplication of work. Indeed, more than 30% of the European standards adopted by CEN are identical to international standards and many more are closely related.

The organs of CEN comprise:

- The General Assembly, a policy body, composed of a representative of each national standardisation body, which directs CEN activities at the highest level, the Administrative Board, which is responsible for the general administration of the system, the CEN Management Centre, which is responsible for the day-to-day management of its activities and the Technical Board, which is responsible for the co-ordination of technical activity and technical decision-making under the procedures for the adoption of standards. Two consultative committees support the Administrative Board in its decision making process: the Consultative Committee for External Policy (CACC EP) and the Consultative Committee for Finance (CACC Finance);

- a system for administering technical activities, organised around the principal sectors of activity;

- the bodies responsible for preparing the standards, which are the technical committees and their working parties,

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composed of experts from all the sectors concerned with standardisation (industry, public authorities, scientists, consumers, trades unions) wishing to make a contribution to technical work at a European level.

CEN’s administrative costs are covered by the subscriptions of its members and resources allocated by the EC and EFTA, but the lion’s share of the total cost of European standardisation, in other words the cost of the expertise required for preparing the standards, is covered by economic operators and particularly by industry.42CENELEC is the European standardisation body in the electro-technical field. It was established on 13 December 1972, although European electrotechnical standardisation had started in the nineteen-sixties.

Like CEN, it is a non-profit-making international association governed by Belgian law whose headquarters are in Brussels. It has twenty-eight full members - the national electrotechnical committees of the Member States of the Union and three EFTA countries - and several afiliated members.

CENELEC covers the field of safety of electrical and electronic appliances, electronic components and information and telecommunications technology (in co-operation with CEN and ETSI).

In order to provide the electrotechnical industry with the standards it requires, CENELEC has signed co-operation agreements with numerous trade federations and European industrial associations. The latter take part in the standardisation process, particularly at the pre-standardisation stage of the work.

On an international level, CENELEC works closely with the IEC (International Electrotechnical Commission), to which it is linked by an information exchange and co-operation agreement,43 comparable with the Vienna Agreement concluded between CEN and ISO.

The organs of CENELEC are, with some minor difierences, similar to those of CEN: a General Assembly, a Board of Administration, a Technical Board, Technical Committees working in accordance with rules common to both CEN and CENELEC, and sub-committees.

ETSI is the European standardisation body which specialises in the field of telecommunications. It is a non-profit-making association governed by French law which was established in 1988 at the initiative of the European Conference of Postal and Telecommunications Administrations (CEPT). Its headquarters are in Sophia Antipolis (France).

ETSI was formed after CEN and CENELEC and does not appear in the initial version of Directive 83/189/EEC. It was added when Annex I was amended in 1992,44after having been oficially recognised as a European standardisation body by the Community institutions.45ETSI arose from the realisation that a pan-European telecommunications infrastructure characterised by a high degree of interoperability was the only way to enable a European market

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for telecommunications equipment and services to be established. It was created in response to the Green Paper published in 1987 by the Commission of the European Communities on ‘the development of a common market for telecommunications services and equipment’,46with a view to accelerating the technical harmonisation which was essential to the growth of networks, industry and new technologies. In spite of the history of its creation, ETSI is an independent organisation, governed by its members.

Centred on advanced technologies within the ICT domain, ETSI is the product of its age, and is increasingly having to respond to the challenges and needs of converging sectors: telecommunications, information technology, broadcasting and entertainment. Throughout the world this convergence is constantly being refiected in new applications (business-to-business communications, teleworking, access to entertainment, scientific databases and games, the development of preventive health care and care at home for the elderly, ‘intelligent’ transportation, etc.). Even within traditional telecommunications, convergence of the technologies associated with fixed networks, mobile networks, other wireless communications, satellite, banking and so on is turning the old order on its head. ETSI is at the forefront of managing this change.

The promised Information Society is truly arriving: Europe is participating in this revolution, and the socio-economic stakes are high. If users are to benefit fully, interconnection and inter-operability of operator networks is essential.

The standards published by ETSI contribute to this objective since they are aimed at ensuring the compatibility of new services ofiered to users as well as of the terminal equipment which is available on the market. These standards cover three main areas:

- multimedia services for industry and for home use,

- terminal services for personal mobile communications,

- next-generation networks that will have universal application both geographically and in terms of their ability to deliver information in whatever form it may exist.

The structures and operation of ETSI difier considerably from those of CEN and CENELEC. Whereas within CEN and CENELEC the work is organised largely around national delegations, ETSI is an open forum which groups together all the market interests who wish to take part in its work and use its standards.

National governments, national standardisation bodies, network operators, equipment manufacturers, users, service suppliers, research bodies, consultancy companies, regulators etc. can all be members of ETSI. Membership can be either on an individual company basis or through national or European bodies.

ETSI has three member categories: Full Members, Associate Members and Observers. All can attend the meetings of the General Assembly, but only Full and Associate Members can vote. As of 2004, ETSI has nearly 700 members.

The organs of ETSI comprise:

- the General Assembly, the supreme authority, composed of all the members, which determines general policy and supervises the administration of the Institution and its activities;

- the Board of Directors, composed entirely of representatives of Full Members;

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- the Technical Organisation, made up of Technical Committees, Projects and Working Groups, which prepare standards and reports;

- the Secretariat (managed by a Director-General (Chief Executive), assisted by a Deputy Director-General), which plays an important role in running ETSI and assists in routine administration;

- Specialist Task Forces set up by the General Assembly for specific tasks and for a defined period.

In accordance with the principle of openness governing its organisation, ETSI is a party to various international agreements, notably with the ISO/IEC, the CEPT and the ITU (International Telecommunication Union).

The work of ETSI is financed in part by the EC and EFTA in the context of mandated work for the preparation of standards in support of Community policies. Other resources come from the subscriptions of members of ETSI, contributions from the national telecommunications authorities, and a small amount from the sale of standards. ETSI’s primary focus for its standards is Europe, naturally, but with a truly international membership (even most of its European members are global players), the Institute seeks to develop standards for world-wide application.

Although they are precisely defined, the functions of CEN, CENELEC and ETSI inevitably overlap in a number of fields, such as the machinery sector or the sector of information and communications technology (ICT), which is situated at the crossroads between information technology, electronic components and telecommunications networks. Co-ordination of the work of these three bodies is therefore essential.

This is mainly done through the ICT Standards Board, which is open to economic operators. It was set up in 1995 to coordinate the work and identify market requirements. In order to do this, it examines the requirements contained in standardisation requests which come in particular from the ‘Industry High Level Strategy Group’ and the European Commission, before organising them into coherent standards programmes. The division of the work between the three bodies takes place within the ICT Standards Board.

The close co-operation between CEN, CENELEC and ETSI is formalised at the highest level by a policy structure common to the three bodies: ‘The Joint Presidents Group’ (JPG), which is responsible for ensuring the most eficient administration possible of the areas of overlapping competence. The JPG, which is composed of a delegation of the administrators and secretaries-general of each of the European standardisation bodies, prepares for this purpose agreements relating to common problems.

It was in this context that an agreement was concluded on the division of tasks for standardisation of electrical vehicles: CENELEC was given responsibility for preparing standards for vehicles connected to the electricity network, whilst CEN is responsible for standards for vehicles independent of the network. Furthermore, the co-operation between CENELEC and ETSI is based on a set of guidelines designed to resolve the difficulties inherent in the overlapping of responsibilities and avoid duplication of efiort. The adoption of the CENELEC/ETSI standards programme for the development of harmonised standards guaranteeing electromagnetic compatibility in the field of telecommunications is another example of the kind of co-operation which must be extended, since the standards programmes will increasingly call for the participation of two or even three European standardisation bodies.

10) ‘national standardisation body’: a body referred to in Annex II;

The national standardisation bodies referred to in Annex II to the Directive are the institutions in the various Member States which are responsible for preparing and publishing standards, in accordance with a procedure which allows all economic and

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social operators concerned to take part in the work on a voluntary basis.47Their tasks are therefore of general interest.

These bodies are, with one or two exceptions, very similar in terms of their constitution, their organs and their operating methods.

They are, in most cases, centralised bodies48in the form of associations supported by the public authorities, which use the national standards as reference documents in specifications for the award of public contracts or for the preparation of national technical regulations.

These institutes have the support of bodies which are normally decentralised and ensure the necessary consensus between the economic and social partners, namely sectoral technical committees composed of unpaid experts provided mainly by industry to prepare standards on subjects in the work programme; bodies providing logistical support and bringing about a consensus through a system of public enquiry; and bodies which publish and sell the standards adopted.

The national standardisation bodies are all members of the European standardisation bodies, whether CEN or CENELEC, and generally also of ISO or the IEC.

This simplified description of the national standardisation bodies does not cover difierences relating to factors such as:

- the degree of dependence of the standardisation body on the public authorities. The legal form of the relationship between the body and the State, formalised contractually (as in Germany or the United Kingdom) or by regulations (as in France, Italy or Spain), is an indicator of this degree of dependence;

- the respective share of the various sources from which the work is financed: voluntary contributions from industry, the sale of standards and additional services (for example, certification), State subsidies;

- the degree of centralisation of the organs responsible for preparing draft standards, which varies according to whether these organs are linked to trade associations (as in France or in Germany), or form part of the national institution (as in the United Kingdom);

- the degree of involvement of the national standardisation body in the organisation of the technical work of CEN or CENELEC;

- the size of the body.

11) ‘technical regulation’, technical specifications and other requirements, or rules on services, including the relevant administrative provisions, the observance of which is compulsory, de jure or de facto, in the case of marketing, provision of a service, establishment of a service operator or use in a Member State or a major part thereof, as well as laws, regulations or administrative provisions of Member States, except those provided for in Article 10, prohibiting the manufacture, importation, marketing or use of a product or prohibiting the provision or use of a service, or establishment as a service provider.

In defining the concept of ‘technical regulation’, Paragraph 11 provides information regarding the type of texts which must

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be notified under the procedure for the provision of information established by the Directive in this field.

On the one hand there are the technical specifications or other requirements or rules on services (see the above definitions), which are laid down by the Member States and which are applicable to industrial and agricultural products and to Information Society services, and on the other there are the laws, regulations and administrative provisions of the Member States which prohibit certain specified activities.

In order to qualify as a technical regulation, a technical specification, an ‘other requirement’ or a rule on services must fulfil the following conditions:

- it must be ‘compulsory’ (i.e. ‘de jure’ or ‘de facto’ binding, see hereinafter). This characteristic, which is inherent in the documents prepared by the public authorities, to which this Directive applies, constitutes the major difierence between a technical regulation and a standard, which is prepared by private bodies and is in essence voluntary;49- it must infiuence the marketing or use of industrial and agricultural products, the provision of a service or the establishment of a service operator, in a Member State or a significant part of that State.

The administrative provisions applicable to a specification, to an ‘other requirement’ or to a rule on services can also constitute technical regulations within the meaning of the Directive. These measures, as with all technical regulations, must be notified under the Directive when they emanate from the central governments of the Member States or from one of their authorities as specified in the list drawn up by the Commission in the framework of the Standing Committee of the Directive.

Certain technical specifications,‘other requirements’or rules on services which meet the definition of technical regulations are excluded from the scope of the Directive, particularly if they comply with binding Community acts or are limited to implementing a judgment of the European Court of Justice, as specified in Article 10 of the Directive.

The ‘compulsory’ nature of a technical specification, an ‘other requirement’ or a rule on services may be conferred upon them in two ways:

  1. de jure, when compliance with them is made compulsory by a measure emanating directly from the relevant public authorities or attributable to the latter.

    By way of example, the conditions regarding the small-scale production of jam and preserved fruit, laid down by decree, will be considered to be a technical regulation which is mandatory de jure. The same will apply to a ban on using plastic bottles for the marketing of mineral water, as laid down by ordinance, etc.

  2. de facto, where the technical specification is not laid down by a formal and binding act of the State concerned, but where the State encourages its observance. As a result of the similar effects which they may have upon trade, these measures are considered equivalent to binding regulations.

    Paragraph 11 gives three examples of the most important and the most frequent de facto technical regulations, in order to clarify a concept which was not defined in the initial version of the Directive and gave rise to difierent interpretations that were prejudicial to the correct implementation of the information procedure.

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    De facto technical regulations include:

    - laws, regulations or administrative provisions of a Member State which refer either to technical specifications or to other requirements or to rules on services, or to professional codes or codes of practice which in turn refer to technical specifications or other requirements or to rules on services, compliance with which confers a presumption of conformity with the obligations imposed by the aforementioned laws, regulations or administrative provisions;

    The laws, regulations or administrative provisions referred to are measures adopted by the national authorities which refer to technical specifications or ‘other requirements’50or to rules

    on services usually laid down by bodies other than the State (by a national standardisation body, for example), which are not compulsory as such (standards, professional codes or codes of practice), but observance of which is encouraged since it confers on the product or the service a presumption of conformity with the provisions of the aforementioned measures.

    Such is the case, in particular, if a law relating to insurance releases the users of products complying with certain non-mandatory standards from the responsibility of proving conformity with mandatory requirements, since these products benefit from a presumption of conformity with the requirements.

    - voluntary agreements to which a public authority is a contracting party and which provide, in the general interest, for compliance with technical specifications or other requirements or rules on services, excluding public procurement tender specifications.

    Agreements entered into between economic operators which establish technical specifications or other requirements for certain products or rules on services are not binding as such owing to their origin in the private sector. They are nevertheless considered to be de facto technical regulations when the State is a signatory party to one of these agreements.

    This circumstance is becoming increasingly frequent, since such agreements have become instruments of national regulatory policy. They are often used by some Member States in sectors such as the automobile industry, chemical industry and oil industry, in most cases for environmental reasons. For example to reduce pollutant vehicle emissions, the discharge of harmful substances into water, or the use of certain types of packaging, etc. In the field of Information Society services, a notified text -a draft Code of Practice on voluntary retention of communication data- provides a good example of such voluntary agreement.

    These agreements allow greater fiexibility in implementing the measures necessary to attain the objectives of the legislation, and the voluntary participation of the industry involved ensures that they will be achieved.

    The State must be involved in these agreements if they are to fall within the scope of Directive 98/34/EC. For the public authority to be able to fulfil the information obligation incumbent on it and take account of comments by the Commission or a Member State in the framework of the information procedure laid down by the Directive, the State must be a contracting party.

    - technical specifications or other requirements or rules on services which are linked to fiscal or financial measures afiecting the consumption of products or services by encouraging compliance with such technical specifications or other requirements or rules on services; technical specifications or other requirements or rules on services linked to national social security systems are not included.

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    The fiscal or financial measures referred to in this paragraph are laid down by the national public authorities for a purpose other than that traditionally pursued by the fiscal legislation of the Member States.

    They are considered to be eficient instruments for implementing policies decided at a national level, particularly with a view to protecting the environment and the recipients of services (notably the consumers), since they are basically aimed at infiuencing the behaviour of the latter with regard to a specific product or service.

    This provision of the Directive came about because of certain cases of tax incentives granted to ‘clean vehicles’ which met certain emission limits or were equipped with catalytic converters. Experience has shown that Member States often linked incentives to conditions, with the result that the system introduced was contrary to Community law. It became clear that there was a need to examine such drafts.

    The category of measures in question includes, in particular, those which seek to encourage the purchase of products complying with certain specifications, by granting financing facilities (for example, subsidies for the purchase of certain heating appliances complying with defined technical requirements) or, alternatively, to discourage their purchase (for example the exclusion of grants in the building industry when materials possessing certain characteristics are used). It also includes fiscal or financial measures which may affect consumption by encouraging compliance with ‘other requirements’ within the meaning of the Directive (for example, exemption from ecotax for the packaging of given products when a deposit system is set up, or exemption from ecotax for certain products when a collection and recycling system is established). Similarly this category of measures concern those aiming at encouraging or discouraging the purchase of services having certain features (e.g. services received via specific devices or originating from operators established in certain areas).

    Directive 98/34/EC does not cover the whole of the fiscal or financial legislation of the Member States; it only refers to technical specifications or ‘other requirements’ or rules on services linked to fiscal or financial measures which have the objective of changing the behaviour of consumers or service recipients. The fiscal or financial measure does not, as such, form the subject of examination by the Commission or the Member States. Only that aspect of the technical specifications, of ‘other requirements’ or of rules on services which may form barriers to trade is examined.

    It should be emphasised that this provision of the Directive does not cover the fiscal or financial measures carried out in support of certain enterprises or products, pursuant to Articles 87 and 88 of the Treaty, relating to State aid, which form the subject of the specific procedure stipulated by the latter.

    Measures connected with the national social security systems are also excluded (for example the regulation which makes the refund of a medicine conditional on a certain type of packaging).

    The last type of technical regulation contemplated by the directive which should be notified (in addition to technical specifications, ‘other requirements’ and rules on services which impose de jure and de facto compulsory requirements) consist of national laws, regulations and administrative provisions intended to prohibit the manufacture, importation, marketing and use of a product or prohibiting the provision or use of a service or the establishment as a service provider.

    To fall within this fourth category of technical regulation concerning a prohibition inter alia on use, the measures must have a scope which goes well beyond a limitation to certain possible uses of the product or the service in question and must not be confined to a mere restriction of their use. That category of technical regulation is particularly intended to cover national measures which leave no room for any use

    Page 32

    which can reasonably be made of the product concerned other than a purely marginal one.51Such prohibitions constitute, as it were, the ultimate form of technical regulation. Unless they can be justified under Article 30 or Article 46 of the Treaty or proportionate in relation to essential requirements within the terms of the case law of the Court of Justice, they constitute barriers par excellence to the free movement of goods and services and to the freedom of establishment within the Community.

    This comprises technical regulations imposed by the authorities designated by the Member States and appearing on a list to be drawn up by the Commission before 5 August 1999, in the framework of the Committee referred to in Article 5.

    The same procedure shall be used for amending this list;

    The list of authorities referred to in this paragraph is published on the Internet Site of the Commission.5212) ‘draft technical regulation’, the text of a technical specification or other requirement or of a rule on services, including administrative provisions, formulated with the aim of enacting it or of ultimately having it enacted as a technical regulation, the text being at a stage of preparation at which substantial amendments can still be made.

    This paragraph defines the concept of ‘draft technical regulation’: in order to be considered a draft, the technical regulation must be at a stage of preparation which will enable ‘substantial amendments’ to be made to the text.

    The procedure for the provision of information laid down by the Directive in the field of technical regulations provides that, on completion of the examination of drafts which it has been sent, the Commission and the Member States can request the regulatory authority to amend any text which is considered to be contrary to the rules of the internal market.

    It is a matter for each Member State to decide, in accordance with the nature of its legislative process, the stage at which its draft technical regulations should be sent to the Commission, as long as it is still possible to make substantial amendments.

    In that regard, it must be observed that a national measure which reproduces or replaces, without adding new or additional specifications, existing technical regulations which, if adopted after the entry into force of Directive 83/189/EEC, have been duly notified to the Commission, cannot be regarded as a‘draft’ technical regulation within the meaning of Article 1(12) of Directive 98/34/EC and consequently, as subject to the obligation to notify.

    This Directive shall not apply to those measures Member States consider necessary under the Treaty for the protection of persons, in particular workers, when products are used, provided that such measures do not afiect the products.

    This provision reinforces a concept already expressed in paragraphs (3) and (4) of the Article, to the efiect that technical specifications which afiect the characteristics of the product are covered.

    [15] OJ L 262, 27.9.1976, p. 169.

    [16] Repealed by Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use. OJ L 311, 28.11.2001, p. 67.

    [17] Within the meaning of former Article 38(1) of the Treaty (today Article 33(1) of the Treaty).

    [18] Case 7/68 Commission of the European Communities v Italian Republic [1968] ECR 617.

    [19] Case 2/90 Commission of the European Communities v Kingdom of Belgium [1992] ECR I-4431.

    [20] The notion of Information Society services was introduced by Directive 98/48/EC and then used in Directive 98/84/EC on the legal protection of services based on, or consisting of, conditional access (OJ L 320, 28.11.1998, p. 54) and Directive 2000/31/EC on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (OJ L 178, 17.7.2000, p. 1). For more information concerning this legal notion and, more generally, on the aspects of Directive 98/34/EC specifically related to Information society services, as introduced by Directive 98/48/EC, one may consult Vade-Mecum to Directive 98/48/EC which Introduces a Mechanism for the Transparency of Regulations on Information Society Services (Doc. S-42/98 - EN (def.) - Directorate-General III - Industry and Directorate-General XV - Internal Market and Financial Services.

    [21] Case C-109/92 ‘Wirth’ [1993] ECR I-6447.

    [22] Directive of 3 October 1989, OJ L 298, 17.10.1989, p. 23.

    [23] Directive of 30 June 1997, OJ L 202, 30.7.1997, p. 60.

    [24] In the ‘Mediakabel’ judgment of 2 June 2005, Case C-89/04, not yet published, the Court of Justice has confirmed that near video on demand is not an Information Society service since it is not provided at the individual request of a recepient of services.

    [25] Council Directive 90/387/EEC of 28 June 1990 on the establishment of the internal market for telecommunications services through the implementation of open network provision (OJ L 192, 24.7.1990, p. 1). This Directive has been repealed by Framework Directive 2002/21/EC of 7 March 2002 on a common framework for electronic communications networks and services (OJ L 108, 24.4.2002, p. 33). However, the definition of‘telecommunications services’found in Directive 90/387/EEC should be retained for the purposes of Directive 98/34/EC.

    [26] This Directive was recently repealed by Directive 2004/39/EC of 21 April 2004 on markets in financial instruments. OJ L 145, 30.4.2004, p. 1.

    [27] Association française de normalisation [French Standards Association].

    [28] Deutsches Institut für Normung [German Standards Institution].

    [29] British Standards Institution.

    [30] Comité européen de Normalisation [European Committee for Standardisation].

    [31] Comité européen de Normalisation électrotechnique [European Committee for Electrotechnical Standardisation].

    [32] European Telecommunications Standards Institute.

    [33] International Standards Organisation.

    [34] International Electrotechnical Commission.

    [35] ISO, Guide 2, Sixth Edition, 1991 (EN 45020:1993).

    [36] See in particular the work by F. Nicolas ‘Common Standards for Enterprises’ - European Commission - Ofice for Oficial Publications of the European Communities, on the role of standardisation as a favoured method of organising economic relationships, ISBN 92-826-8111-4.

    [37] The details of these bodies are given in Annex 2 to this booklet.

    [38] This New Approach to technical harmonisation was later supplemented by the Council resolution of 21 December 1989 on a Global Approach to certification and testing which lays down the guiding principles for Community policy on conformity assessment (OJ C 10, 16.1.1990, p. 1). The Global Approach was completed by Council Decision 93/465/EC (OJ L 220, 30.8.1993, p. 23) which lays down general guidelines and detailed procedures for conformity assessment that are to be used in New Approach Directives.

    [39] Iceland, Norway, Switzerland.

    [40] Albania, Bulgaria, Croatia, Romania and the Former Yugoslav Republic of Macedonia (FYROM).

    [41] European Association for the Co-ordination of Consumer Representation in Standardisation (ANEC)
    European Chemical Industry Council (CEFIC)
    European Environmental Citizens Organisation for Standardisation (ECOS)
    European Committee for Co-operation of the Machine Tool Industries (CECIMO)
    European Medical Technology Industry Association (EUCOMED)
    European Ofice of Craft/Trades and Small and Medium-sized Enterprises for Standardisation (NORMAPME) European Trade Union Technical Bureau for Health and Safety (TUTB)
    European Construction Industry Federation - FIEC

    [42] More information about CEN can be obtained from or by writing to

    [43] Lugano Agreement, signed by CENELEC and the IEC in October 1991, which became the Dresden Agreement in 1996.

    [44] Decision 92/400/EEC of 15 July 1992, OJ L 221, 6.8.1992, p. 55.

    [45] Before the standardisation of telecommunications became established on a European level, the telecommunications sector was almost exclusively covered by national regulations. Since there was no certainty that the Member States would adopt the recommendations of the CEPT, there was no efiective harmonisation at the time.

    [46] COM(87) 290 final, 30.6.1987.

    [47] A list of national standardisation contacts is given in annex 2 to this booklet. However, the formal list of national standardisation bodies is to be found in annex II of the directive.

    [48] In the United States and Canada, on the other hand, the publication of standards is the responsibility of several hundred specialist organisations, each in a specific sector.

    [49] We shall see later, under Article 7(2) of the Directive that, in certain cases, compliance with the standard may become mandatory, so that it then acquires the status of a ‘technical regulation’.

    [50] In the meaning of Article 1(3) and (4) of the Directive, as explained above.

    [51] Case C-267/03 ‘Lars Erik Stafian Lindberg’, judgment of 21 April 2005, not yet published.


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