Proposal for a European Parliament and Council Directive on connected telecommunications equipment and the mutual recognition of the conformity of equipment (97/C 248/04) (Text with EEA relevance) COM(97) 257 final - 97/0149(COD)

(Submitted by the Commission on 6 June 1997)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 100a,

Having regard to the proposal from the Commission,

Having regard to the opinion of the Economic and Social Committee,

Acting in accordance with the procedure referred to in Article 189b of the Treaty,

1. Whereas Council Directive 91/263/EEC of 29 April 1991, on the approximation of the laws of the Member States concerning telecommunications terminal equipment, including the mutual recognition of their conformity (1), amended by Directive 93/68/EEC (2), further developed the measures for the mutual recognition of the conformity of telecommunications terminal equipment;

2. Whereas Council Directive 93/97/EEC (3) supplemented Directive 91/263/EEC in respect of satellite earth station equipment;

3. Whereas a regulatory regime aimed at the development of a single market for terminal and radio equipment should permit investment, manufacture and sale to take place at the pace of technology and market developments; whereas, as a result of liberalization of the infrastructure new definitions of network termination points and terminal equipment will be required; whereas, in general, the network termination points to be considered are those of public telecommunications networks; whereas in certain cases in the public interest, terminal equipment for connection to other types of network termination points should be subject to regulation;

4. Whereas the European Parliament and Council Directive on the application of open network provision (ONP) to voice telephony and on universal service for telecommunications in a competitive environment (4) calls on national regulatory authorities to ensure the publication of details of technical interface specifications for network access for the purpose of ensuring a competitive market for the supply of terminal equipment;

5. Whereas the essential requirements related to electromagnetic compatibility laid down by Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of Member States relating to electromagnetic compatibility (5), as last amended by Directive 93/68/EEC, are sufficient to cover connected telecommunications equipment;

6. Whereas the provisions of Council Directive 73/23/EEC of 19 February 1973 on the harmonization of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits (6), as last amended by Directive 93/68/EEC, are sufficient to cover connected telecommunications equipment, whatever the operating voltage limits;

7. Whereas certain essential requirements specific to terminal and radio equipment may be necessary in order to protect the public interest;

8. Whereas unacceptable degradation of service to other than the user of connected telecommunications equipment should be prevented;

9. Whereas harmonized interfaces between terminal equipment and telecommunications networks ensure the coexistence of competitive markets for both terminal equipment and network services;

10. Whereas connected telecommunications equipment can occupy an excessive proportion of limited resources such as radio frequency spectrum;

11. Whereas the Commission may need to take into account certain Community-wide requirements where justified in the public interest;

12. Whereas the essential requirements relevant to a class of connected telecommunications equipment should depend on the nature and the needs of that class of equipment; whereas these requirements must be applied with discernment in order not to inhibit technological innovation or the meeting of the needs of a free-market economy;

13. Whereas care should be taken that connected telecommunications equipment should not represent an avoidable hazard to health;

14. Whereas telecommunications are important to the well-being and employment of people with disabilities who represent a substantial and growing proportion of the population of Europe;

15. Whereas connected telecommunications equipment can provide certain functions required by emergency and security services;

16. Whereas connected telecommunications equipment should not permit the infringement of individual privacy;

17. Whereas, to enable the Commission to monitor effectively the control of the market, it is necessary that Member States provide the relevant information concerning types of network termination points, inadequate or incorrectly applied harmonized standards, notified bodies and surveillance authorities;

18. Whereas it is desirable to have harmonized standards at European level to safeguard the public interest in connection with the design and manufacture of connected telecommunications equipment; whereas such harmonized standards may be used to demonstrate conformity to the essential requirements;

19. Whereas Community law provides that obstacles to the free movement of goods within the Community, resulting from disparities in national legislation relating to the marketing of products, can only be justified where any national requirements are necessary and proportionate; whereas, therefore, the harmonization of laws must be limited only to those requirements necessary to satisfy the essential requirements relating to connected telecommunications equipment; whereas these requirements must replace the relevant national requirements;

20. Whereas connected telecommunications equipment which complies with the relevant essential requirements should be permitted to circulate freely and be put into service in all Member States; whereas connected telecommunications equipment which does not comply with the applicable essential requirements should be regarded as defective products within the meaning of Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (7);

21. Whereas manufacturers or their authorized representatives established within the Community who are responsible for placing products on the Community market which do not comply with the relevant essential requirements should be liable according to provisions equivalent to those in Directive 85/374/EEC, modified, as necessary to meet the needs of telecommunications equipment;

22. Whereas on 22 July the Council adopted Decision 93/465/EEC concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and the use of CE conformity marking, intended to be used in the technical harmonization directives (8); whereas the conformity assessment procedures applicable should be chosen from the available modules laid down by that decision;

23. Whereas it is desirable to establish a committee bringing together parties directly concerned with the implementation of regulation of terminal and radio equipment, in particular the national bodies designated for certifying conformity and national bodies responsible for market surveillance, to assist the Commission in achieving a harmonized and proportionate application of the provisions which meet the needs of the market and the public at large; whereas representatives from the telecommunications organizations, users, consumers, manufacturers, and service providers should be consulted where appropriate;

24. Whereas it is necessary to ensure that with the introduction of changes to the regulatory regime there is a smooth transition from the previous regime in order to avoid disruption to the market and legal uncertainty;

25. Whereas the telecommunications terminal equipment sector is an essential part of the telecommunications market, which is a key element of the economy in the Community; whereas the Directives applicable to telecommunications terminal equipment sector are no longer capable of accommodating the expected changes in the sector caused by new technology, market developments and network legislation;

26. Whereas the Commission should review on a periodic basis which categories of terminal equipment no longer require Community standards relating to interfaces between public networks and terminal equipment, taking due account of the progress in implementation of competition in the public network provision market;

27. Whereas this directive replaces Directive 91/263/EEC, Directive 93/97/EEC and Article 11 of Directive 93/68/EEC, which should accordingly be repealed;

28. Whereas in accordance with the principles of subsidiarity and proportionality referred to in Article 3b of the Treaty, the objective of creating an open competitive single market for telecommunications equipment cannot be effectively achieved by the Member States and therefore is better achieved at a Community level; whereas this directive is limited to the minimum requirements necessary to meet this objective and does not exceed that which is necessary to achieve this aim,

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I GENERAL ASPECTS

Article 1

Scope and aim

This directive establishes a European Community regulatory framework for the placing on the market, free circulation and putting into service of Connected Telecommunications Equipment (CTE) which complies with the essential requirements.

Article 2

Definitions

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

(a) Connected Telecommunications Equipment (CTE)

Equipment capable of communication by means of radio transmission utilizing the spectrum allocated to terrestrial/space radio communication excluding equipment which is intended for exclusive public security use, or

the relevant components of equipment to be connected to an Open Network Termination Point, allowing this equipment to interwork with the relevant network;

(b) Open Telecommunications Network Termination Point (ONTP)

A termination point of a telecommunications network at which users of the network may connect any conforming Connected Telecommunications Equipment of a type supported at that ONTP. Connection may be by wire, radio, optical or other electromagnetic means. An ONTP supports one or more types of CTE. In exceptional cases in the public interest, ONTP types can be termination points of other than public networks;

(c) CTE Type:

The CTE type identifies the type of Open Network Termination Point to which the equipment is to be connected by wire, radio, optical or other electromagnetic means;

(d) Technical specification

A specification contained in a document which describes those characteristics of a product which implement the applicable essential requirements;

(e) Harmonized standard

A technical specification adopted by a recognized standards body under a mandate from the Commission in conformity with the procedures laid down in Council Directive 83/189/EEC (9) for the purpose of establishing a European requirement, compliance with which is not compulsory.

Article 3

Essential requirements

1. The following general essential requirements are applicable to all CTE:

(a) the essential requirements contained in Directive 73/23/EEC with respect to safety whatever the voltage limits of the CTE;

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

2. The specific essential requirements applicable to each type of CTE may be selected in accordance with the provisions of Article 4 from the following list:

(a) prevention of misuse of network resources causing an unacceptable degradation of service to other than the user of the CTE;

(b) interworking via network(s) and Community-wide portability between ONTPs of the same type;

(c) effective use of the spectrum allocated to terrestrial/space radio communication.

Article 4

Identification of relevant specific essential requirements

1. The Commission shall identify the specific essential requirements applicable to each CTE type in accordance with the procedure laid down in Article 12. In selecting the applicable essential requirements, the Commission shall give, as appropriate, due consideration to:

(a) protection of health;

(b) features for users with disabilities;

(c) features for emergency and security services;

(d) protection of individual privacy.

The applicable specific essential requirements shall be published in the Official Journal of the European Communities.

2. Member States shall notify the Commission of the types of ONTP which are available or due to become available as soon as they are aware of them. In turn, the Commission shall inform the Committee referred to in Article 12 (hereinafter referred to as 'the Committee`) of existing and planned ONTP types.

3. Member States shall ensure that the operators of all networks publish and regularly update accurate and adequate technical specifications of the available ONTPs and the CTE types supported. The specifications should be in sufficient detail to permit the design of compatible CTE.

Article 5

Harmonized standards

1. When CTE meets the relevant harmonized standards 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 and Article 4 as are covered in these standards. At the choice of the manufacturer and, in particular, in the absence of a harmonized standard, compliance with the relevant essential requirements can be demonstrated by means of compliance with a technical specification appropriate to the relevant essential requirements.

2. Where a Member State or the Commission considers that a harmonized standard referred to in paragraph 1 does not conform to the selected specific essential requirements referred to in Article 3 (2) and Article 4 (1), the Commission or the Member State concerned shall bring the matter before the Committee and initiate the procedures described in Article 12.

Article 6

Placing on the market and putting into service

1. Member States shall ensure that CTE which complies with the appropriate essential requirements identified in Article 3 (1) and (2) and Article 4 (1) is permitted to circulate freely and is not subject to further national regulation. Where the specific essential requirements for a type of CTE have not yet been determined, a manufacturer shall not be subject to national regulation and may place the CTE on the market provided he complies with the general essential requirements identified in Article 3 (1). CTE which complies with the essential requirements applicable at the time of first placing on the market can continue to be placed on the market.

2. Member States shall ensure that connection of CTE to appropriate ONTPs is not refused on the grounds of technical incompatibility when the CTE complies with the requirements of Article 3.

3. Member States shall ensure that, when placed on the market, CTE is accompanied by documentation informing the potential purchaser or user of the CTE that the equipment complies with the relevant essential requirements and of any usage conditions resulting from the selection of essential requirements. These usage conditions should include, inter alia, the ONTP type(s) to which the CTE may be connected and any limitations on use made necessary by lack of harmonization of radio spectrum.

Article 7

Non-compliance

1. Where a Member State finds that CTE being placed on the market in its territory does not comply with the essential requirements relevant to the CTE type, it shall take all appropriate measures to withdraw such products from the market and prohibit their being placed on the market.

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

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

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

(c) use of an inappropriate technical specification.

3. Where the non-compliance referred to in paragraph 2 is attributed to shortcomings in the harmonized standards applicable, the Commission shall bring the matter before the Committee within two months of the date of notification by the Member State.

4. The Commission shall keep the Member State informed of the progress and outcome of any procedure initiated pursuant to paragraph 3.

Article 8

Liability for non-compliance

1. Manufacturers or their authorized representatives established within the Community who place products on the Community market which do not comply with the applicable essential requirements shall be liable for damage as described in Article 9 of Directive 85/374/EEC and for direct economic damage suffered as a consequence of the non-compliance. The economic damage shall not include any anticipated profits.

2. Manufacturers or their authorized representatives established within the Community shall not be liable for the damages referred to in paragraph 1 if they can prove that the essential requirement(s) with which their product does not comply had not been identified pursuant to Article 4 at the time when the equipment was placed on the market.

CHAPTER II CONFORMITY ASSESSMENT

Article 9

Conformity assessment procedures

1. The conformity assessment procedures identified in this Article will be used to demonstrate the compliance of the CTE with all the relevant essential requirements identified in Article 3 (1) and (2) and Article 4 (1).

2. CTE which does not make use of the spectrum allocated to terrestrial/space radio communication shall be subject to internal production control, as described in Annex I.

3. CTE which does make use of the spectrum allocated to terrestrial/space radio communication shall be subject to internal production control and specific product tests, as described in Annex II.

4. The records and correspondence relating to the production control procedures referred to in paragraphs 2 and 3 shall be in an official language of the Member State where the said procedure will be carried out, or in a language accepted by the notified body involved.

Article 10

Notified bodies and surveillance authorities

1. Member States shall notify the Commission and the other Member States of the bodies which they have designated to carry out the relevant tasks referred to in Article 9. Member States shall apply the criteria laid down in Annex III in assessing the bodies to be notified.

2. 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. Member States shall provide the Commission with all information necessary to keep the list up to date.

3. Member States shall notify the Commission and the other Member States of the authorities established within their territory which carry out the surveillance tasks related to the operation of this directive.

CHAPTER III CE CONFORMITY MARKING AND INSCRIPTIONS

Article 11

CE marking

1. CTE complying with the relevant essential requirements shall bear the CE conformity marking referred to in Annex IV. It shall be affixed by the manufacturer or his authorized representative within the Community. Where appropriate, it shall be accompanied by the identification number of the notified body referred to in Article 10 (2). Any other marking may be affixed to the equipment provided that the visibility and legibility of the CE marking is not thereby reduced.

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

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

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

CHAPTER IV COMMITTEE

Article 12

Constitution and procedures

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

2. The Committee shall be consulted on the matters covered by Articles 4, 5 and 7.

3. The Committee may be consulted, where necessary, on the effectiveness of the surveillance tasks related to the operation of this directive.

4. 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 immediately.

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.

5. 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.

CHAPTER V FINAL AND TRANSITIONAL PROVISIONS

Article 13

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 [31 December 1999] and every third year thereafter. This review shall inter alia assess whether the scope of the directive should be maintained or should be reduced taking account of technical development. 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, and assess progress in achieving an open competitive market for CTE at Community level. It shall in particular examine whether essential requirements are still necessary for all categories of terminal equipment covered.

Article 14

Transitional provisions

1. The harmonized standards or parts thereof identified through Common Technical Regulations adopted under Directive 91/263/EEC or Directive 93/97/EEC may be used as the basis for a presumption of conformity with the specific essential requirements referred to Article 3 (2) and Article 4 (1) until such time as the Commission indicates, by publication in the Official Journal of the European Communities, that they are no longer applicable.

2. Any measure adopted by Member States in accordance with Directive 91/263/EEC or Directive 93/97/EEC shall continue to be valid.

Article 15

Transposition

1. Member States shall take the measures necessary to comply with this directive not later than [1 July 1999]. They shall forthwith inform the Commission thereof.

When Member States adopt these provisions, they shall contain a reference to this directive or shall be accompanied by such reference at the time of their official publication. The procedure for such 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 16

Repeal

Directive 91/263/EEC, Directive 97/97/EC and Article 11 of Directive 93/68/EEC are hereby repealed.

Article 17

Entry into force

This directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.

Article 18

Addressees

This directive is addressed to the Member States.

(1) OJ No L 128, 23. 5. 1991, p. 1.

(2) OJ No L 220, 30. 8. 1993, p. 1.

(3) OJ No L 290, 24. 11. 1993, p. 1.

(4) Not yet published.

(5) OJ No L 139, 23. 5. 1989, p. 19.

(6) OJ No L 77, 26. 3. 1973, p. 29.

(7) OJ No L 210, 7. 8. 1985, p. 29.

(8) OJ No L 220, 30. 8. 1993, p. 23.

(9) OJ No L 109, 26. 4. 1983, p. 8.

ANNEX I

Conformity assessment procedure referred to in Article 9 (2) (1)

Module A (internal production control)

1. This module describes the procedure whereby the manufacturer or his authorized representative established within the Community, who carries out the obligations laid down in paragraph 2, ensures and declares that the products concerned satisfy the requirements of this Directive that apply to them. The manufacturer or his authorized representative established within the Community must affix the CE marking to each product and draw up a written declaration of conformity.

2. The manufacturer must establish the technical documentation described in paragraph 3 and he or his authorized representative established within the Community must keep it for a period ending at least ten years after the last product has been manufactured at the disposal of the relevant national authorities for inspection purposes.

3. Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the product on the Community market.

4. The technical documentation must enable the conformity of the product with the essential requirements to be assessed. It must cover the design, manufacture and operation of the product, in particular:

- a general description of the product,

- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc,.

- descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product,

- a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the directive where such standards referred to in Article 5 have not been applied or do not exist,

- results of design calculations made, examinations carried out, etc.,

- test reports.

5. The manufacturer or his authorized representative must keep a copy of the declaration of conformity with the technical documentation.

6. The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the manufactured products with the technical documentation referred to in paragraph 2 and with the requirements of this Directive that apply to them.

(1) Annex I and Annex 2 are extracted from Decision 93/465/EEC (OJ No L 220, 30. 8. 1993, p. 23) of 22 July 1993, concerning the modules for the various phases of the conformity assessment procedures . . ., as supported by the 'Guide to the implementation of Community harmonization directives based on the new approach and the global approach - First Version` (Luxembourg, Office for Official Publications of the European Communities, 1994, ISBN 92-826-8584-5). Any changes in these documents which may affect the wording of Annex I or II should be taken into account by the Council).

ANNEX II

Conformity assessment procedure referred to in Article 9 (3)

Module Aa (Internal production control plus specific product tests)

This Annex consists of Annex I, plus the following supplementary requirement:

For each product, all essential radio test consequences must be carried out by the manufacturer or on his behalf. The identification of the test consequences that are considered to be essential is the responsibility of a notified body chosen by the manufacturer.

On the responsibility of the notified body, the manufacturer must affix the former's identification number during the manufacturing process.

ANNEX III

Minimum criteria to be taken into account by Member States when designating notified bodies in accordance with Article 10 (1)

1. The notified body, its director and the staff responsible for carrying out the tasks for which the notified body has been designated shall not be a designer, manufacturer, supplier or installer of terminal or radio equipment, or a network operator or a service provider, nor the authorized representative of any of such parties. They shall be independent and not become directly involved in the design, construction, marketing or maintenance of terminal or radio equipment, nor represent the parties engaged in these activities. This does not preclude the possibility of exchanges of technical information between the manufacturer and the notified body.

2. The notified body and its staff must carry out the tasks for which the notified body has been designated with the highest degree of professional integrity and technical competence and must be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of any inspection, especially from persons or groups of persons with an interest in such results.

3. The notified body must have at its disposal the necessary staff and facilities to enable it to perform properly the administrative and technical work associated with the tasks for which it has been designated.

4. The staff responsible for inspections must have:

- sound technical and professional training,

- satisfactory knowledge of the requirements of the tests or inspections that are carried out and adequate experience of such tests or inspections,

- the ability to draw up the certificates, records and reports required to authenticate the performance of the inspections.

5. The impartiality of inspection staff must be guaranteed. Their remuneration must not depend on the number of tests or inspections carried out nor on the results of such inspections.

6. The notified body must take out liability insurance unless its liability is assumed by the Member State in accordance with national law, or the Member State itself is directly responsible.

7. The staff of the notified body is bound to observe professional secrecy with regard to all information gained in carrying out its tasks (except vis-à-vis the competent administrative authorities of the Member State in which its activities are carried out) under this Directive or any provision of national law giving effect thereto.

ANNEX IV

Marking of equipment referred to in Article 11 (1)

1. The CE conformity marking shall consist of the initials 'CE` taking the following form.

>REFERENCE TO A GRAPHIC>

If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.

2. The CE marking must have a height of at least 5 mm.

3. The CE marking must be affixed to the product or to its data plate. However, where this is not possible or not warranted on account of the nature of the product, it must be affixed to the packaging, if any, and to the accompanying documents.

4. The CE marking must be affixed visibly, legibly and indelibly.