Legal provisions of COM(1997)257 - Connected telecommunications equipment and the mutual recognition of the conformity of equipment

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dossier COM(1997)257 - Connected telecommunications equipment and the mutual recognition of the conformity of equipment.
document COM(1997)257 EN
date March  9, 1999


Contents

CHAPTER I - GENERAL ASPECTS

Article 1 - Scope and aim

1. This Directive establishes a regulatory framework for the placing on the market, free movement and putting into service in the Community of radio equipment and telecommunications terminal equipment.

2. Where apparatus as defined in Article 2(a) incorporates, as an integral part, or as an accessory:

(a) a medical device within the meaning of Article 1 of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(15), or

(b) an active implantable medical device within the meaning of Article 1 of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices(16),

the apparatus shall be governed by this Directive, without prejudice to the application of Directives 93/42/EEC and 90/385/EEC to medical devices and active implantable medical devices, respectively.

3. Where apparatus constitutes a component or a separate technical unit of a vehicle within the meaning of Council Directive 72/245/EEC(17) relating to the radio interference (electromagnetic compatibility) of vehicles or a component or a separate technical unit of a vehicle within the meaning of Article 1 of Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two or three-wheel motor vehicles, the apparatus shall be governed by this Directive without prejudice to the application of Directive 72/245/EEC or of Directive 92/61/EEC respectively.

4. This Directive shall not apply to equipment listed in Annex I.

5. This Directive shall not apply to apparatus exclusively used for activities concerning public security, defence, State security (including the economic well-being of the State in the case of activities pertaining to State security matters) and the activities of the State in the area of criminal law.

Article 2 - Definitions

For the purpose of this Directive the following definitions shall apply:

(a) 'apparatus' means any equipment that is either radio equipment or telecommunications terminal equipment or both;

(b) 'telecommunications terminal equipment' means a product enabling communication or a relevant component thereof which is intended to be connected directly or indirectly by any means whatsoever to interfaces of public telecommunications networks (that is to say, telecommunications networks used wholly or partly for the provision of publicly available telecommunications services);

(c) 'radio equipment' means a product, or relevant component thereof, capable of communication by means of the emission and/or reception of radio waves utilising the spectrum allocated to terrestrial/space radiocommunication;

(d) 'radio waves' means electromagnetic waves of frequencies from 9 kHz to 3000 GHz, propagated in space without artificial guide;

(e) 'interface' means

(i) a network termination point, which is a physical connection point at which a user is provided with access to public telecommunications network, and/or

(ii) an air interface specifying the radio path between radio equipment

and their technical specifications;

(f) 'equipment class' means a class identifying particular types of apparatus which under this Directive are considered similar and those interfaces for which the apparatus is designed. Apparatus may belong to more than one equipment class;

(g) 'technical construction file' means a file describing the apparatus and providing information and explanations as to how the applicable essential requirements have been implemented;

(h) 'harmonised standard' means a technical specification adopted by a recognised standards body under a mandate from the Commission in conformity with the procedures laid down in Directive 98/34/EC for the purpose of establishing a European requirement, compliance with which is not compulsory.

(i) 'harmful interference' means interference which endangers the functioning of a radionavigation service or of other safety services or which otherwise seriously degrades, obstructs or repeatedly interrupts a radiocommunications service operating in accordance with the applicable Community or national regulations.

Article 3 - Essential requirements

1. The following essential requirements are applicable to all apparatus:

(a) the protection of the health and the safety of the user and any other person, including the objectives with respect to safety requirements contained in Directive 73/23/EEC, but with no voltage limit applying;

(b) the protection requirements with respect to electromagnetic compatibility contained in Directive 89/336/EEC.

2. In addition, radio equipment shall be so constructed that it effectively uses the spectrum allocated to terrestrial/space radio communication and orbital resources so as to avoid harmful interference.

3. In accordance with the procedure laid down in Article 15, the Commission may decide that apparatus within certain equipment classes or apparatus of particular types shall be so constructed that:

(a) it interworks via networks with other apparatus and that it can be connected to interfaces of the appropriate type throughout the Community; and/or that

(b) it does not harm the network or its functioning nor misuse network resources, thereby causing an unacceptable degradation of service; and/or that

(c) it incorporates safeguards to ensure that the personal data and privacy of the user and of the subscriber are protected; and/or that

(d) it supports certain features ensuring avoidance of fraud; and/or that

(e) it supports certain features ensuring access to emergency services; and/or that

(f) it supports certain features in order to facilitate its use by users with a disability.

Article 4 - Notification and publication of interface specifications

1. Member States shall notify the interfaces which they have regulated to the Commission insofar as the said interfaces have not been notified under the provisions of Directive 98/34/EC. After consulting the committee in accordance with the procedure set out in Article 15, the Commission shall establish the equivalence between notified interfaces and assign an equipment class identifier, details of which shall be published in the Official Journal of the European Communities.

2. Each Member State shall notify to the Commission the types of interface offered in that State by operators of public telecommunications networks. Member States shall ensure that such operators publish accurate and adequate technical specifications of such interfaces before services provided through those interfaces are made publicly available, and regularly publish any updated specifications. The specifications shall be in sufficient detail to permit the design of telecommunications terminal equipment capable of utilising all services provided through the corresponding interface. The specifications shall include, inter alia, all the information necessary to allow manufacturers to carry out, at their choice, the relevant tests for the essential requirements applicable to the telecommunications terminal equipment. Member States shall ensure that those specifications are made readily available by the operators.

Article 5 - Harmonised standards

1. Where apparatus meets the relevant harmonised standards or parts thereof whose reference numbers have been published in the Official Journal of the European Communities, Member States shall presume compliance with those of the essential requirements referred to in Article 3 as are covered by the said harmonised standards or parts thereof.

2. Where a Member State or the Commission considers that conformity with a harmonised standard does not ensure compliance with the essential requirements referred to in Article 3 which the said standard is intended to cover, the Commission or the Member State concerned shall bring the matter before the committee.

3. In the case of shortcomings of harmonised standards with respect to the essential requirements, the Commission may, after consulting the committee and in accordance with the procedure laid down in Article 14, publish in the Official Journal of the European Communities guidelines on the interpretation of harmonised standards or the conditions under which compliance with that standard raises a presumption of conformity. After consultation of the committee and in accordance with the procedure laid down in Article 14, the Commission may withdraw harmonised standards by publication of a notice in the Official Journal of the European Communities.

Article 6 - Placing on the market

1. Member States shall ensure that apparatus is placed on the market only if it complies with the appropriate essential requirements identified in Article 3 and the other relevant provisions of this Directive when it is properly installed and maintained and used for its intended purpose. It shall not be subject to further national provisions in respect of placing on the market.

2. In taking a decision regarding the application of essential requirements under Article 3(3), the Commission shall determine the date of application of the requirements. If it is determined that an equipment class needs to comply with particular essential requirements under Article 3(3), any apparatus of the equipment class in question which is first placed on the market before the date of application of the Commission's determination can continue to be placed on the market for a reasonable period. Both the date of application and the period shall be determined by the Commission in accordance with the procedure laid down in Article 14.

3. Member States shall ensure that the manufacturer or the person responsible for placing the apparatus on the market provides information for the user on the intended use of the apparatus, together with the declaration of conformity to the essential requirements. Where it concerns radio equipment, such information shall be sufficient to identify on the packaging and the instructions for use of the apparatus the Member States or the geographical area within a Member State where the equipment is intended to be used and shall alert the user by the marking on the apparatus referred to in Annex VII, paragraph 5, to potential restrictions or requirements for authorisation of use of the radio equipment in certain Member States. Where it concerns telecommunications terminal equipment, such information shall be sufficient to identify interfaces of the public telecommunications networks to which the equipment is intended to be connected. For all apparatus such information shall be prominently displayed.

4. In the case of radio equipment using frequency bands whose use is not harmonised throughout the Community, the manufacturer or his authorised representative established within the Community or the person responsible for placing the equipment on the market shall notify the national authority responsible in the relevant Member State for spectrum management of the intention to place such equipment on its national market.

This notification shall be given no less than four weeks in advance of the start of placing on the market and shall provide information about the radio characteristics of the equipment (in particular frequency bands, channel spacing, type of modulation and RF-power) and the identification number of the notified body referred to in Annex IV or V.

Article 7 - Putting into service and right to connect

1. Member States shall allow the putting into service of apparatus for its intended purpose where it complies with the appropriate essential requirements identified in Article 3 and the other relevant provisions of this Directive.

2. Not withstanding paragraph 1, and without prejudice to conditions attached to authorisations for the provision of the service concerned in conformity with Community law, Member States may restrict the putting into service of radio equipment only for reasons related to the effective and appropriate use of the radio spectrum, avoidance of harmful interference or matters relating to public health.

3. Without prejudice to paragraph 4, Member States shall ensure that operators of public telecommunications networks do not refuse to connect telecommunications terminal equipment to appropriate interfaces on technical grounds where that equipment complies with the applicable requirements of Article 3.

4. Where a Member State considers that apparatus declared to be compliant with the provisions of this Directive causes serious damage to a network or harmful radio interference or harm to the network or its functioning, the operator may be authorized to refuse connection, to disconnect such apparatus or to withdraw it from service. The Member States shall notify each such authorisation to the Commission, which shall convene a meeting of the committee for the purpose of giving its opinion on the matter. After the committee has been consulted, the Commission may initiate the procedures referred to in Article 5(2) and (3). The Commission and the Member States may also take other appropriate measures.

5. In case of emergency, an operator may disconnect apparatus if the protection of the network requires the equipment to be disconnected without delay and if the user can be offered, without delay and without costs for him, an alternative solution. The operator shall immediately inform the national authority responsible for the implementation of paragraph 4 and Article 9.

Article 8 - Free movement of apparatus

1. Member States shall not prohibit, restrict or impede the placing on the market and putting into service in their territory of apparatus bearing the CE marking referred to in Annex VII, which indicates its conformity with all provisions of this Directive, including the conformity assessment procedures set out in Chapter II. This shall be without prejudice to Articles 6(4), 7(2) and 9(5).

2. At trade fairs, exhibitions, demonstrations, etc., Member States shall not create any obstacles to the display of apparatus which does not comply with this Directive, provided that a visible sign clearly indicates that such apparatus may not be marketed or put into service until it has been made to comply.

3. Where the apparatus is subject to other directives which concern other aspects and also provide for the affixing of the CE marking, the latter shall indicate that such apparatus also fulfils the provisions of those other directives. However, should one or more of those directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the apparatus fulfils the provisions only of those directives applied by the manufacturer. In this case, the particulars of those directives, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by those directives and accompanying such products.

Article 9 - Safeguards

1. Where a Member State ascertains that apparatus within the scope of this Directive does not comply with the requirements of this Directive, it shall take all appropriate measures in its territory to withdraw the apparatus from the market or from service, prohibit its placing on the market or putting into service or restrict its free movement.

2. The Member State concerned shall immediately notify the Commission of any such measures indicating the reasons for its decision and whether non-compliance is due to:

(a) incorrect application of the harmonised standards referred to in Article 5(1);

(b) shortcomings in the harmonised standards referred to in Article 5(1);

(c) failure to satisfy the requirements referred to in Article 3 where the apparatus does not meet the harmonised standards referred to in Article 5(1).

3. If the measures referred to in paragraph 1 are attributed to incorrect application of the harmonised standards referred to in Article 5(1) or to a failure to satisfy the requirements referred to in Article 3 where the apparatus does not meet the harmonised standards referred to in Article 5(1), the Commission shall consult the parties concerned as soon as possible. The Commission shall forthwith inform the Member States of its findings and of its opinion as to whether the measures are justified, within two months of notification of the said measures to the Commission.

4. Where the decision referred to in paragraph 1 is attributed to shortcomings in the harmonised standards referred to in Article 5(1), the Commission shall bring the matter before the committee within two months. The committee shall deliver an opinion in accordance with the procedure laid down in Article 14. After such consultation, the Commission shall inform the Member States of its findings and of its opinion as to whether the action by the Member State is justified. If it finds that the action is justified it shall forthwith initiate the procedure referred to in Article 5(2).

5. (a) Notwithstanding the provisions of Article 6, a Member State may, acting in conformity with the Treaty, and in particular Articles 30 and 36 thereof, adopt any appropriate measures with a view to:

(i) prohibiting or restricting the placing on its market, and/or

(ii) requiring the withdrawal from its market,

of radio equipment, including types of radio equipment, which has caused or which it reasonably considers will cause harmful interference, including interference with existing or planned services on nationally allocated frequency bands.

(b) Where a Member State takes measures in accordance with subparagraph (a) it shall immediately inform the Commission of the said measures, specifying the reasons for adopting them.

6. When a Member State notifies the Commission of a measure referred to in paragraph 1 or 5 the Commission shall in turn inform other Member States and consult the committee on the matter.

Where, after such consultation, the Commission considers that:

- the measure is justified, it shall immediately so inform the Member State which took the initiative and the other Member States,

- the measure is unjustified, it shall immediately so inform the Member State and request it to withdraw the measure.

7. The Commission shall maintain a record of the cases notified by Member States, which shall be made available to them on request.

CHAPTER II - CONFORMITY ASSESSMENT

Article 10 - Conformity assessment procedures

1. The conformity assessment procedures identified in this Article shall be used to demonstrate the compliance of the apparatus with all the relevant essential requirements identified in Article 3.

2. At the choice of the manufacturer, compliance of the apparatus with the essential requirements identified in Article 3(1)(a) and (b) may be demonstrated using the procedures specified in Directive 73/23/EEC and Directive 89/336/EEC respectively, where the apparatus is within the scope of those Directives, as an alternative to the procedures laid out below.

3. Telecommunications terminal equipment which does not make use of the spectrum allocated to terrestrial/space radio communication and receiving parts of radio equipment shall be subject to the procedures described in any one of Annexes II, IV or V at the choice of the manufacturer.

4. Where a manufacturer has applied the harmonised standards referred to in Article 5(1), radio equipment not within the scope of paragraph 3 shall be subject to the procedures described in any one of Annexes III, IV or V at the choice of the manufacturer.

5. Where a manufacturer has not applied or has only applied in part the harmonised standards referred to in Article 5(1), radio equipment not within the scope of paragraph 3 of this Article shall be subject to the procedures described in either of Annexes IV or V at the choice of the manufacturer.

6. Records and correspondence relating to the conformity assessment procedures referred to in paragraphs 2 to 5 shall be in an official language of the Member State where the procedure will be carried out, or in a language accepted by the notified body involved.

Article 11 - Notified bodies and surveillance authorities

1. Member States shall notify the Commission of the bodies which they have designated to carry out the relevant tasks referred to in Article 10. Member States shall apply the criteria laid down in Annex VI in determining the bodies to be designated.

2. Member States shall notify the Commission of the authorities established within their territory which are to carry out the surveillance tasks related to the operation of this Directive.

3. The Commission shall publish a list of the notified bodies, together with their identification numbers and the tasks for which they have been notified, in the Official Journal of the European Communities. The Commission shall also publish a list of surveillance authorities in the Official Journal of the European Communities. Member States shall provide the Commission with all information necessary to keep these lists up to date.

CHAPTER III - CE CONFORMITY MARKING AND INSCRIPTIONS

Article 12 - CE marking

1. Apparatus complying with all relevant essential requirements shall bear the EC conformity marking referred to in Annex VII. It shall be affixed under the responsibility of the manufacturer, his authorized representative within the Community or the person responsible for placing the apparatus on the market.

Where the procedures identified in Annex III, IV or V are used, the marking shall be accompanied by the identification number of the notified body referred to in Article 11(1). Radio equipment shall in addition be accompanied by the equipment class identifier where such indentifier has been assigned. Any other marking may be affixed to the equipment provided that the visibility and legibility of the EC marking is not thereby reduced.

2. No apparatus, whether or not it complies with the relevant essential requirements, may bear any other marking which is likely to deceive third parties as to the meaning and form of the EC marking specified in Annex VII.

3. The competent Member State shall take appropriate action against any person who has affixed a marking not in conformity with paragraphs 1 and 2. If the person who affixed the marking is not identifiable, appropriate action may be taken against the holder of the apparatus at the time when non-compliance was discovered.

4. Apparatus shall be identified by the manufacturer by means of type, batch and/or serial numbers and by the name of the manufacturer or the person responsible for placing the apparatus on the market.

CHAPTER IV - THE COMMITTEE

Article 13 - Constitution of the committee

The Commission shall be assisted by a committee, the Telecommunication Conformity Assessment and Market Surveillance Committee (TCAM), composed of representatives of the Member States and chaired by a representative of the Commission.

Article 14 - Advisory committee procedure

1. The committee shall be consulted on the matters covered by Articles 5, 6(2), 7(4), 9(4) and Annex VII(5).

2. The Commission shall consult the committee periodically on the surveillance tasks related to the application of this Directive, and, where appropriate, issue guidelines on this matter.

3. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.

The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.

The Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into account and decide within one month after having received the opinion of the committee.

4. The Commission shall periodically consult the representatives of the telecommunications networks providers, the consumers and the manufacturers. It shall keep the committee regularly informed of the outcome of such consultations.

Article 15 - Regulatory committee procedure

1. Notwithstanding the provisions of Article 14, the following procedure shall apply in respect of the matters covered by Articles 3(3) and 4(1).

2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.

3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.

If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.

If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.

CHAPTER V - FINAL AND TRANSITIONAL PROVISIONS

Article 16 - Third countries

1. Member States may inform the Commission of any general difficulties encountered, de jure or de facto, by Community undertakings with respect to placing on the market in third countries, which have been brought to their attention.

2. Whenever the Commission is informed of such difficulties, it may, if necessary, submit proposals to the Council for an appropriate mandate for negotiation of comparable rights for Community undertakings in these third countries. The Council shall decide by qualified majority.

3. Measures taken pursuant to paragraph 2 shall be without prejudice to the obligations of the Community and of the Member States under relevant international agreements.

Article 17 - Review and reporting

The Commission shall review the operation of this Directive and report thereon to the European Parliament and to the Council, on the first occasion not later than 7 October 2000 18 months after the entry into force of this Directive and every third year thereafter. The report shall cover progress on drawing up the relevant standards, as well as any problems that have arisen in the course of implementation. The report shall also outline the activities of the committee, assess progress in achieving an open competitive market for apparatus at Community level and examine how the regulatory framework for the placing on the market and putting into service of apparatus should be developed to:

(a) ensure that a coherent system is achieved at Community level for all apparatus;

(b) allow for convergence of the telecommunications, audiovisual and information technology sectors;

(c) enable harmonisation of regulatory measures at international level.

It shall in particular examine whether essential requirements are still necessary for all categories of apparatus covered and whether the procedures contained in Annex IV, third paragraph, are proportionate to the aim of ensuring that the essential requirements are met for apparatus covered by that Annex. Where necessary, further measures may be proposed in the report for full implementation of the aim of the Directive.

Article 18 - Transitional provisions

1. Standards under Directive 73/23/EEC or 89/336/EEC whose references have been published in the Official Journal of the European Communities may be used as the basis for a presumption of conformity with the essential requirements referred to in Article 3(1)(a) and Article 3(1)(b). Common technical regulations under Directive 98/13/EC whose references have been published in the Official Journal of the European Communities may be used as the basis for a presumption of conformity with the other relevant essential requirements referred to in Article 3. The Commission shall publish a list of references to those standards in the Official Journal of the European Communities immediately after this Directive enters into force.

2. Member States shall not impede the placing on the market and putting into service of apparatus which is in accordance with the provisions in Directive 98/13/EC or rules in force in their territory and was placed on the market for the first time before this Directive entered into force or at the latest two years after this Directive entered into force.

3. Apart from the essential requirements referred to in Article 3(1), the Member States may request to continue, for a period of up to 30 months following the date referred to in the first sentence of Article 19(1), and in conformity with the provisions of the Treaty, to require telecommunications terminal equipment not to be capable of causing unacceptable deterioration of a voice telephony service accessible within the framework of the universal service as defined in Directive 98/10/EC.

The Member State shall inform the Commission of the reasons for requesting a continuation of such a requirement, the date by which the service concerned will no longer need the requirement, and the measures envisaged in order to meet this deadline. The Commission shall consider the request taking into account the particular situation in the Member State and the need to ensure a coherent regulatory environment at Community level, and shall inform the Member State whether it deems that the particular situation in that Member State justifies a continuation and, if so, until which date such continuation is justified.

Article 19 - Transposition

1. Member States shall not later than 7 April 2000 adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply these provisions as from 8 April 2000.

When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by Member States.

2. Member States shall inform the Commission of the main provisions of domestic law which they adopt in the field covered by this Directive.

Article 20 - Repeal

1. Directive 98/13/EC is hereby repealed as from 8 April 2000.

2. This Directive is not a specific directive within the meaning of Article 2(2) of Directive 89/336/EEC. The provisions of Directive 89/336/EEC shall not apply to apparatus falling within the scope of this Directive, with the exception of the protection requirements in Article 4 and Annex III and the conformity assessment procedure in Article 10(1) and (2) of, and Annex I to, Directive 89/336/EEC, as from 8 April 2000.

3. The provisions of Directive 73/23/EEC shall not apply to apparatus falling within the scope of this Directive, with the exceptions of the objectives with respect to safety requirements in Article 2 and Annex I and the conformity assessment procedure in Annex III, Section B, and Annex IV to Directive 73/23/EEC, as from 8 April 2000.

Article 21 - Entry into force

This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.

Article 22 - Addressees

This Directive is addressed to the Member States.