CELEX: 51990PC0263
Language: en
Date: 1990-06-19
Title: AMENDED PROPOSAL FOR A COUNCIL DIRECTIVE ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING TELECOMMUNICATIONS TERMINAL EQUIPMENT, INCLUDING THE MUTUAL RECOGNITION OF THEIR CONFORMITY

No C 187/40                              Official Journal of the European Communities                                   27. 7. 90
              Proposal for a Council Regulation (EEC) amending Regulation (EEC) No 1352/90 fixing rice prices
                                                  for the 1990/91 marketing year
                                                         COM(90) 246 final
                                       (Submitted by the Commission on 15 June 1990)
                                                           (90/C 187/08)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                             HAS ADOPTED THIS REGULATION:
Having regard to the Treaty establishing the European                                          Article 1
Economic Community,
                                                                     Article 1 of Regulation (EEC) No 1352/90 is hereby
Having regard to the Act of Accession of Spain and Portugal,         replaced by the following:
and in particular Article 89 (2) thereof,
                                                                          'Article 1
Having regard to the proposal from the Commission,                       For the 1990/91 marketing year, rice prices shall be as
                                                                         follows:
                                                                         (a) intervention price for paddy rice: ECU 314,19 per
Having regard to the opinion of the European Parliament,
                                                                               tonne;
                                                                         (b) target price for husked rice: ECU 546,88 per
Whereas, pursuant to Articles 68 and 70 (1) of the Act of                      tonne.'
Accession of Spain and Portugal, Council Regulation (EEC)
No 1352/90 (l) provides for an intervention price level in
Spain which is different from that applying in the                                             Article 2
Community as constituted on 31 December 1985;
                                                                     This Regulation shall enter into force on the third day
                                                                     following its publication in the Official Journal of the
Whereas, in view of the changes which have occurred since
                                                                     European Communities.
accession in the intervention mechanisms, from the 1990/91
marketing year the intervention price for rice in Spain should       It shall apply from 1 September 1990.
be aligned with that applying in the Community as
constituted on 31 December 1985,
                                                                     This Regulation shall be binding in its entirety and directly
(») OJ No L 134, 28. 5. 1990, p. 17.                                 applicable in all Member States.
              Amended proposal for a Council Directive on the approximation of the laws of the Member States
              concerning telecommunications terminal equipment, including the mutual recognition of their
                                                             conformity
                                                 COM(90) 263 final — SYN 204
               (Submitted by the Commission pursuant to Article 149 (3) of the EEC Treaty on 20 June 1990)
                                                           (90/C 187/09)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                             Having regard to the opinion of the Economic and Social
                                                                     Committee,
Having regard to the Treaty establishing the European
Economic Community, and in particular Article 100A
                                                                     Whereas Council Directive 86/361/EEC (*) introduced the
thereof,
                                                                     initial stage of the mutual recognition of type approval for
Having regard to the proposal from the Commission,                   telecommunications terminal equipment and in particular in
In cooperation with the European Parliament,                             OJNoL217, 5. 8. 1986, p. 21.
 ---pagebreak--- 27. 7. 90                                 Official Journal of the European Communities                                  No C 187/41
its Article 9 envisaged a further stage for full mutual              Whereas Council Directive 73 / 23 / EEC of 19 February 1973
recognition of type approval for terminal equipment;                 on the harmonization of the laws of the Member States
                                                                     relating to electrical equipment designed for use within
                                                                     certain voltage limits (5) and Council Directive 83/189/EEC
Whereas Council Decision 87/95/EEC (x) sets out the                  of 28 March 1983 laying down a procedure for the provision
measures to be implemented for the promotion of                      of information in the field of technical standards and
standardization in Europe and the preparation and                    regulations ( 6 ), as amended by Directive 88/182/EEC ( 7 ),
implementation of standards in the field of information              are applicable, inter alia, to the fields of telecommunications
technology and telecommunications;                                   and information technology;
Whereas the Commission has issued a Green Paper on the               Whereas Council Directive 89/336/EEC of 3 May 1989 on
development of the common market for telecommunications              the approximation of the laws of Member States relating to
services and equipment (2) proposing to accelerate the               electromagnetic compatibility (8) is applicable, inter alia,
introduction of the full mutual recognition of type approval         to the fields of telecommunications and information
as the measure vital for the development of a competitive            technology;
Community-wide terminal market;
                                                                     Whereas in respect of the essential safety requirements and in
Whereas the Council in its resolution of 30 June 1988 on the         order to help manufacturers to prove conformity to these
development of the common market for telecommunications              essential requirements it is desirable to have standards
services and equipment up to 1992 (3) considers as a major           harmonized at European level for the prevention of hazards
goal in the telecommunications policy the full mutual                arising out of the design and manufacture of terminal
recognition of type approval for terminal equipment on the           equipment and in order to allow checks of conformity to the
basis of the rapid development of common European                    essential requirements; whereas these standards harmonized
conformity specifications;                                           at European level are drawn up by private-law bodies and
                                                                     must retain their non-binding status; whereas for this
Whereas the terminal equipment sector is a vital part of the         purpose the European Committee for Standardization
telecommunications industry which is one of the industrial           (CEN) and the European Committee for Electrotechnical
mainstays of the Community economy;                                  Standardization (Cenelec) are the bodies recognized as
                                                                     competent to adopt harmonized standards in accordance
                                                                     with the general guidelines for cooperation between the
Whereas the Council resolution of 7 May 1985 ( 4 ), provides         Commission and these two bodies signed on 13 November
for a new approach to technical harmonization and                    1984; whereas within the meaning of this Directive a
standards;                                                           harmonized standard is a technical specification (European
                                                                     standard or harmonization document) adopted by either or
                                                                     both of these bodies, on the basis of a remit from the
Whereas the field of application of the Directive must be            Commission in accordance with the provisions of Directive
based on a general definition of the term 'terminal equipment'       83/189/EEC, and on the basis of the general guidelines
so as to allow the technical development of products;                referred to above;
Whereas Community law, in its present form, provides —               Whereas the formal adoption of the statutes of the European
notwithstanding one of the fundamental rules of the                  Telecommunications Standards Institue (ETSI) on 12
Community, namely the free movement of goods — that                  February 1988 creates a new opportunity to produce
obstacles to movement within the Community, resulting                harmonized standards in the telecommunications field;
from disparities in national legislation relating to the             whereas after implementation by the Member States of the
marketing of products must be accepted in so far as such             ETSI rules of procedures which depend on their authority it
requirements can be recognized as being necessary to satisfy         will be possible to introduce ETSI into the framework of
imperative       requirements; whereas, therefore,          the      European standardization as stipulated in Directive
harmonization of laws in this case must be limited only to            83/189/EEC;
those requirements necessary to satisfy the essential
requirements relating to terminal equipment; whereas these
 requirements must replace the relevant national                     Whereas in respect of the essential requirements related to
requirements because they are essential;                             interworking with public telecommunications networks, it is
                                                                     in general not possible to comply with such requirements
                                                                     other than by the application of unique solutions; whereas
Whereas the essential requirements must be satisfied in order        such solutions shall therefore be mandatory;
to safeguard the general interest; whereas these requirements
 must be applied with discernment to take account of the state
 of the art at the time of manufacture and economic                  Whereas it is essential to ensure that notified bodies are of a
 requirements;                                                       high standard throughout the Community and meet
(!) O J N o L 3 6 , 7. 2. 1987, p. 31.                                (s) OJ No  L 77, 26. 3. 1973, p. 29.
(2) COM(87) 290.                                                      (6) OJ No  L 109, 26. 4. 1983, p. 8.
(3) OJ No C 257, 4. 10. 1988, p. 1.                                  (7)  OJ No  L 81, 26. 3. 1988, p. 75.
(4) O J N o C 1 3 6 , 4 . 6. 1985, p. 1.                              (8) OJ No  L 139, 23. 5. 1989, p. 19.
 ---pagebreak--- No C 187/42                                Official Journal of the European Communities                                       27. 7. 90
minimum criteria of competence, impartiality and financial            3.     The intended purpose shall be declared by the
and other independence from clients;                                  manufacturer or supplier of the equipment.
Whereas it is appropriate to set up a committee bringing
together parties directly concerned with the implementation
of this Directive, in particular the national bodies designated                                       Article 2
for certifying conformity, to assist the Commission in
executing the tasks entrusted to it by this Directive; whereas        Member States shall take all necessary steps to ensure that
representatives of the telecommunications organizations,              terminal equipment may be placed on the market and put
users, consumers, manufacturers, service providers and the            into service only if it complies with the requirements laid
trade unions should have the right to be consulted;                   down in this Directive when it is properly installed and
                                                                      maintained and used for its intended purpose.
Whereas the Member States' responsibility for safety, health
and the other aspects covered by the essential requirements
on their territory must be recognized in a safeguard clause
                                                                                                      Article 3
providing for adequate Community protection procedures;
                                                                      Terminal equipment shall satisfy the following essential
Whereas the addressees of any decision taken under this
                                                                      requirements, when they are relevant:
Directive must be informed of the reasons for such a decision
and the means of appeal open to them;                                 (a) user safety in so far as this requirement is not covered by
                                                                            Directive 7 3 / 2 3 / E E C ;
Whereas the measures aimed at the gradual establishment of
the internal market must be adopted by 31 December 1992;              (b) safety of employees of public telecommunications
whereas the internal market consists of an area without                     network operators in so far as this requirement is not
internal frontiers within which the free movement of goods,                 covered by Directive 7 3 / 2 3 / E E C ;
persons, services and capital is guaranteed,
                                                                      (c) protection of the public telecommunications network
                                                                            from harm;
                                                                      (d) interworking of terminal equipment with network
HAS ADOPTED THIS DIRECTIVE:                                                 equipment for the purpose of establishing, modifying,
                                                                            charging for, and clearing real or virtual connections;
                                                                      (e) interworking of terminal equipment, in justified cases,
                                                                            as determined in accordance with the procedure laid
                                                                            down in Article 13.
                           CHAPTER I
      Scope, placing on the market and free movement
                                                                                                      Article 4
                                                                      Member States shall not impede the placing on the market
                            Article 1
                                                                      and the free circulation and use on their territory of terminal
                                                                      equipment which complies with the provisions of this
 1.     This Directive shall apply to terminal equipment.             Directive.
2.      For the purposes of this Directive terminal equipment
means equipment intended:
                                                                                                      Article S
(a) to be connected to the termination of a public
      telecommunications network by an electrically                    1.     Member States shall presume compliance with the
      conductive system;                                              essential requirements referred to in Article 3 (a) and (b) in
      and/or                                                          respect of terminal equipment which is in conformity with
                                                                      the national standards implementing the relevant
(b) to interwork        with   a public     telecommunications        harmonized standards the references of which have been
      network;                                                        published in the Official Journal of the European
      and/or                                                           Communities. Member States shall publish the references of
                                                                       such national standards.
(c) to interwork        via   a    public   telecommunications
      network.                                                         2.     The Commission, in accordance with the procedure
                                                                       laid down in Article 13, shall decide which harmonized
For cases (b) and (c) the system of connection to support the          standards, implementing the essential requirements referred
interworking may be wire, radio, optical, or other                     to in Article 3 (c), (d) and (e) will be transformed in whole or
electromagnetic systems.                                               in part into technical regulations compliance with which
 ---pagebreak--- 27. 7. 90                                  Official Journal of the European Communities                               No C 187/43
shall be mandatory and the references of which shall be               4.     The Commission shall keep the Member States
published in the Official Journal of the European                     informed of the progress and outcome of this procedure.
Communities.
                            Article 6
                                                                                                CHAPTER II
Where a Member State or the Commission considers that the
                                                                                          Conformity assessment
harmonized standards referred to in Article 5 do not entirely
meet or exceed the essential requirements referred to in
Article 3, the Commission or the Member State concerned
shall bring the matter before the Committee referred to in                                        Article 8
Article 12, hereinafter referred to as 'the Committee', giving
the reasons therefor. The Committee shall deliver an opinion          1.     According to the choice of the manufacturer or
wihout delay.                                                         his authorized representative established within the
                                                                      Community, terminal equipment shall be subject to either
In the light of the Committee's opinion and after consultation        EC type examination, as described in Annex 1, or to EC
of the Standing Committee set up by Directive 83/189/ EEC,            declaration of conformity, as described in Annex 4.
the Commission shall inform the Member States whether or
not it is necessary to withdraw references to those standards         2.     An EC type examination as described in Annex 1 shall
and any related technical regulations from the Official               be accompanied by a declaration issued according to the EC
Journal of the European Communities.                                  declaration of conformity to type procedure as described in
                                                                      Annex 2 or 3.
                                                                      3.     The records and correspondence relating to the
                            Article 7                                 procedures referred to in this Article shall be in an official
                                                                      language of the Member State where the said procedure will
1.      Where a Member State finds that terminal equipment            be carried out, or in a language acceptable to the notified
bearing the EC mark under the provisions laid down in                 body involved.
chapter III does not comply with the relevant essential
requirements when properly used in accordance with the
purpose intended by the manufacturer, it shall take all
appropriate measures to withdraw such products from the                                           Article 9
market or to prohibit or restrict their being placed on the
market.                                                               1.     Member States shall notify to the other Member States
                                                                      and the Commission the bodies which they have designated
                                                                      for carrying out tasks pertaining to the procedures referred to
The Member State concerned shall immediately inform the
                                                                      in Article 8, the specific tasks for which each body has been
Commission of any such measure indicating the reasons for
                                                                      designated, and the identification codes of the designated
its decision, and in particular whether non-compliance is due
                                                                      bodies.
to:
(a) incorrect application of the harmonized standards                 The Commission shall publish the list of these notified bodies
      referred to in Article 5;                                       together with the tasks for which they have been designated,
                                                                      in the Official Journal of the European Communities and
(b) shortcomings in the harmonized standards referred to in           shall keep the list up to date.
      Article 5 themselves.
                                                                      2.     Member States shall apply the minimum criteria, set
2.      The Commission shall enter into consultation with the         out in Annex 5, for the designation of bodies. Bodies that
parties concerned as soon as possible. Where, after such              satisfy the criteria fixed by the relevant harmonized
consultation, the Commission finds that any measure as                standards shall be presumed to satisfy the criteria set out in
referred to in paragraph 1 is justified it shall immediately so       Annex 5.
inform the Member State that took the action and the other
Member States. Where the decision referred to in                      3.     A Member State that has designated a body shall annul
paragraph 1 is attributed to shortcomings in the harmonized           the designation if the body no longer meets the criteria for
standards, the Commission, after consulting the parties               designation referred to in paragraph 2. It shall immediately
concerned, shall bring the matter before the Committee                inform the other Member States and the Commission
within two months if the Member State which has taken the             accordingly and withdraw the notification.
measures intends to maintain them, and shall initiate the
procedure referred to in Article 6.                                   4.     In order to facilitate the determination of conformity
                                                                      of terminal equipment with technical regulations and
3.     Where terminal equipment which does not comply                 standards, the notified bodies shall recognize documentation
with the relevant essential requirements bears the EC mark            issued by third country relevant bodies, when agreements
the competent Member State shall take appropriate action              between the Community and the third country concerned
against whomsoever has affixed the mark and shall inform              have been concluded on the basis of a mutually-satisfactory
the Commission and the other Member States thereof.                   understanding.
 ---pagebreak--- No C 187/44                               Official Journal of the European Communities                                     27. 7. 90
                         CHAPTER III                                 of such consultations, with a view to taking due account of
                                                                     this outcome.
           EC mark of conformity and inscriptions
                           Article 10                                                           Article 13
1.     The EC mark of conformity, which shall consist of the         1.     The representative of the Commission shall submit to
symbol 'CE' in conformity with the specimen in Annex 6,              the Committee established in Article 12, a draft of the
shall be affixed to terminal equipment in a clearly visible,         measures to be taken as referred to in Article 5 (2). The
easily legible and indelible form. It shall be followed by the       Committee shall deliver its opinion on the draft within a time
last two digits of the year in which it was affixed.                 limit which the chairman may lay down according to the
                                                                     urgency of the matter. The opinion shall be delivered by the
2.     The affixing of marks which are likely to be confused         majority laid down in Article 148 (2) of the Treaty in the case
with the EC mark of conformity shall be prohibited.                  of decisions which the Council is required to adopt on a
                                                                     proposal from the Commission. The votes of the
3.     Terminal equipment shall be identified by the                 representatives of the Member States within the Committee
manufacturer by means of type, batch, or serial numbers and          shall be weighted in the manner set out in that Article. The
the manufacturer's name.                                             chairman shall not vote.
                                                                     2.     The Commission shall adopt the measures envisaged
                           Article 11                                if they are in accordance with the opinion of the
                                                                     Committee.
Where it is established that the EC mark has been affixed to
terminal equipment which:
                                                                     3.     If the measures envisaged are not in accordance with
— does not conform to an approved type,                              the opinion of the Committee, or if no opinion is delivered,
                                                                     the Commission shall, without delay, submit to the Council a
— conforms to an approved type which does not meet the               proposal relating to the measures to be taken. The Council
     essential requirements applicable to it,                        shall act by qualified majority. If, within three months of the
or, where the manufacturer has failed to fulfil his obligations      proposal being submitted to it, the Council has not acted, the
under the relevant EC declaration of conformity,                     proposed measures shall be adopted by the Commission.
the notified body shall withdraw the EC type examination
certificate as referred to in Annex 1, the EC quality system
approval certificate, as referred to in Annex 3 or the EC
design examination certificate as referred to in Annex 4, as
relevant, notwithstanding any decisions taken pursuant to                                      CHAPTER V
Article 7.
                                                                                    Final and transitional provisions
                          CHAPTER IV                                                             Article 14
                           Committee
                                                                      1.    Where, for a given terminal equipment, harmonized
                                                                      standards as referred to in Article 5 do not exist, national
                                                                     conformity specifications shall be applicable. These national
                           Article 12                                conformity specifications shall not impose requirements
                                                                      beyond those strictly necessary to respect the essential
 1.     A Standing Committee for terminal equipment is               requirements set out in Article 3.
hereby set up. The Committee shall be called the Approvals
Committee for Telecommunications Equipment (ACTE).
The Committee shall be composed of representatives                    The right to place on the market terminal equipment, which
                                                                      has received national type approval on the basis of national
 appointed by the Member States. It shall be chaired by a
                                                                      conformity specifications, may be limited to the territory
 representative of the Commission. Each Member State shall
                                                                      of the Member State where the national conformity
 appoint two representatives. The representatives may be
                                                                      specification applies except if it complies with a national
 accompanied by experts.
                                                                      specification of another Member State and is intended for
                                                                      re-sale or for use in this Member State.
 The Committee shall draw up its own rules of procedure.
 2.     The Commission will periodically consult the                  2.     A national authority shall recognize, for the purpose of
representatives of the telecommunications organizations, the          national type approval, a certificate of conformity to its own
consumers, the manufacturers, the service providers and the           national conformity specification, accompanied by the
 trade unions and will inform the Committee on the outcome            appropriate test reports, which has been issued by an notified
 ---pagebreak--- 27. 7. 90                                  Official Journal of the European Communities                                      No C 187/45
body of another Member State and shall not impose a                                                  Article 15
requirement for any repetition of tests.
                                                                         Directive 86/361/EEC is hereby repealed with effect from
                                                                         (1 January 1992) (1).
A national authority shall recognize, for the purpose of
national type approval, a certificate of conformity based on
the national conformity specifications of another Member
State provided that these conformity specifications are                                              Article 16
equivalent to those used in the Member State of the
authority.                                                               1.    Member States shall introduce the measures necessary
                                                                         to comply with this Directive referred not later than
                                                                         (1 January 1992) C1). They shall forthwith inform the
                                                                         Commission thereof.
                        Article 14a                                      The provisions adopted pursuant to the first subparagraph
                                                                         shall make express reference to this Directive.
The Commission shall draw up a report every two years on                 2.    Member States shall inform the Commission of the
the implementation of this Directive, including progress on              provisions of national law which they adopt in the field
drawing up the relevant harmonized standards and on                      governed by this Directive.
transforming them into mandatory technical regulations, as
well as any problems that have arisen in the course of
implementation. The report will also outline the activities of                                       Article 17
the Committee established in Article 12, and assess progress
in achieving an open competitive market for terminal                     This Directive is addressed to the Member States.
equipment at Community level consistent with the essential
requirements in Article 3.                                               (J) To be adapted at the date of adoption of the Directive.
                                                               ANNEX 1
                                                       EC TYPE EXAMINATION
                   The EC type examination is that part of the procedure by which a notified body ascertains and attests that
                   terminal equipment,representative of the production envisaged and hereinafter called the 'type', conforms
                   to the essential requirements that apply to it.
                   The application for EC type examination shall be lodged by the manufacturer or his authorized
                   representative established within the Community with one of the notified bodies designated to carry out EC
                   type examination.
                   The application shall include:
                   — the name and address of the manufacturer and, if the application is lodged by the authorized
                       representative, his name and address in addition,
                   — a written declaration that the application has not been lodged with any other notified body,
                   — the technical documentation, as described in paragraph 3.
                   The applicant shall place the type, in the required quantity, at the disposal of the notified body.
                   The technical documentation shall enable understanding of the design, manufacture and operation of the
                   product, so far as is relevant for assessment of conformity of the product with the essential requirements
                   that apply to it.
                   The documentation shall contain so far as relevant for assessment:
                   — a general description of the type,
                   — 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,
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                   — a list of the standards referred to in Article 5, applied in full or in part, declarations of conformity to the
                       standards referred to in Article 5(1) where such standards have been applied, and descriptions of the
                       solutions adopted to meet the essential requirements where the standards referred to in Article 5(1)
                       have not been applied,
                   — results of design calculations made, examinations carried out, etc.,
                   — test reports.
          4.       The notified body shall,
          4.1.     examine the technical documentation, verify that the type has been manufactured in conformity with the
                   technical documentation and identify the elements which have been designed in accordance with the
                   relevant provisions of the standards referred to in Article 5 (1), as well as the elements which have been
                   designed without applying the relevant provisions of those standards;
          4.2.     perform or have performed the appropriate examinations and necessary tests to check whether, where the
                   standards referred to in Article 5(1) have not been applied, the solutions adopted by the manufacturer meet
                   the essential requirements of the Directive referred to in Article 3 (a) and (b);
          4.3.     perform or have performed the appropriate examinations and necessary tests to check that the type
                   complies with the relevant harmonized standards referred to in Article 5 (2).
          5.       Where the type conforms to the applicable essential requirements the notified body shall issue an EC type
                   examination certificate to the applicant. The certificate shall contain the name and address of the
                   manufacturer, conclusions of the examination, conditions for its validity and the necessary data for
                   identification of the approved type.
                   Relevant parts of technical documentation shall be annexed to the certificate and kept by the notified
                   body.
          6.       The applicant shall keep the notified body that has issued the EC type examination certificate informed of
                   any modification to the approved type.
                   Modifications to the approved type must receive additional approval from the notified body that issued the
                   EC type examination certificate where such changes may affect the conformity with the essential
                   requirements or the prescribed conditions for use of the product. This additional approval is given in the
                   form of an addition to the original EC type examination certificate.
          7.       Each notified body shall publish periodically the relevant information concerning:
                   — the applications for EC type examination received,
                   — the EC type examination certificates and additions issued,
                   — the EC type examination certificates and additions refused,
                   — the EC type examination certificates and additions withdrawn.
          8.       The other notified bodies may receive copies of the EC type examination certificates and / or their additions
                   and any annexes.
                                                                 ANNEX     2
                                         EC DECLARATION OF CONFORMITY T O TYPE
          1. This declaration of conformity is that part of the procedure whereby the manufacturer ensures and declares
               that the products concerned are in conformity with the type as described in the EC type examination certificate
               and satisfy the requirements of the Directive that apply to them. The manufacturer shall affix the EC mark to
               each product and draw up a written declaration of conformity.
          2. The manufacturer shall take all measures necessary in order that the manufacturing process shall ensure
               compliance of the manufactured products with the type as described in the EC type examination certificate and
              with the requirements of the Directive that apply to them.
 ---pagebreak--- 27. 7. 90                                  Official Journal of the European Communities                                           No C 187/47
          3. A notified body chosen by the manufacturer shall carry out or have carried out product checks at random
               intervals. An adequate sample of the final products, taken on site by the notified body, shall be examined and
               appropriate tests as set out in the relevant standard(s) referred to in Article 5, shall be carried out to check the
               conformity of the production output with the the relevant requirements of the Directive. In those cases where
               one or more of the products checked do not conform the notified body shall take appropriate measures.
                                                                 ANNEX     3
                 EC DECLARATION OF CONFORMITY TO TYPE (PRODUCTION QUALITY ASSURANCE)
          1.       This declaration of conformity is that part of the procedure whereby a manufacturer who satisfies the
                   obligations of paragraph 2 ensures and declares that the products concerned are in conformity with the
                   type as described in the EC type examination certificate and satisfy the requirements of the Directive that
                   apply to them. The manufacturer shall affix the EC mark to each product and shall draw up a written
                   declaration of conformity.
          2.       The manufacturer shall operate an approved quality system for production, final product inspection and
                   testing as specified in paragraph 3 and shall be subject to EC surveillance as specified in paragraph 4.
          3.       Quality system
          3.1.     The manufacturer shall lodge an application for assessment of his quality system with one of the notified
                   bodies designated to carry out quality system approval.
                   The application shall include:
                   — all relevant information for the product category envisaged,
                   — the quality system's documentation,
                   — an undertaking to carry out the obligations arising from the quality system as approved,
                   — an undertaking to maintain the quality system as approved to ensure its continuing suitability and
                       effectiveness,
                   — if applicable, the technical documentation of the approved type and a copy of the EC type examination
                       certificate.
          3.2.     The quality system shall ensure compliance of the products with the type as described in the EC type
                   examination certificate and with the requirements of the Directive that apply to them.
                   All the elements, requirements and provisions adopted by the manufacturer shall be documented in a
                   systematic and orderly manner in the form of written policies, procedures and instructions. This quality
                   system documentation shall ensure a common understanding of the quality programmes, plans, manuals
                   and records.
                   It shall contain in particular an adequate description of:
                   — the quality objectives and the organizational structure, responsibilities and powers of the management
                       with regard to product quality,
                   — the manufacturing, quality control and quality assurance techniques, processes and systematic actions
                       that will be used,
                   — the examinations and tests that will be carried out before, during and after manufacture and the
                       frequency with which they will be carried out,
                   — the means to monitor the achievement of the required product quality and the effective operation of the
                       quality system.
          3.3.     The notified body shall assess the quality system to determine whether it satisfies the requirements referred
                   to in paragraph 3.2. It shall presume conformity with these requirements in respect of quality systems that
                   implement the relevant harmonized standard.
                   The assessment team shall have at least one member experienced as an assessor in the product technology
                   concerned. The evaluation procedure shall include an assessment visit to the manufacturer's premises.
 ---pagebreak--- No C 187/48                            Official Journal of the European Communities                                           27. 7. 90
               The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the
               examination and the reasoned assessment decision. Where the notified body decides to approve the quality
               system it shall issue an EC quality system approval certificate.
          3.4. The manufacturer or his authorized representative shall keep the notified body that has approved the
               quality system informed of any intended modification to the quality system.
               The notified body shall evaluate the modifications proposed and decide whether the amended quality
               system will still satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is
               required.
               It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the
               examination and the reasoned assessment decision.
          4.   EC surveillance
          4.1. The purpose of EC surveillance is to make sure that the manufacturer duly fulfils the obligations arising out
               of the approved quality system.
          4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of
               manufacture, inspection, testing and storage and shall provide it with all necessary information, in
               particular:
               — the quality system documentation,
               — the quality records, such as inspection reports and test data, calibration data, qualification reports of
                   the personnel concerned, etc.
          4.3. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and
               applies the quality system and shall provide an audit report to the manufacturer.
          4.4. Additionally the notified body may pay unexpected visits to the manufacturer. During such visits full or
               reduced audits may be carried out by the notified body. The notified body shall provide a visit report and, if
               applicable, an audit report to the manufacturer.
          5.   Each notified body shall publish periodically the relevant information concerning the EC quality system
               approval certificates issued and withdrawn.
                                                           ANNEX     4
                         EC DECLARATION OF CONFORMITY (FULL QUALITY ASSURANCE)
          1.   This declaration of conformity is the procedure whereby the manufacturer who satisfies the obligations of
               paragraph 2 ensures and declares that the products concerned satisfy the requirements of the Directive that
               apply to them. The manufacturer shall affix the EC mark to each product and draw up a written
               declaration of conformity.
          2.   The manufacturer shall operate an approved quality system for design, manufacture and final product
               inspection and testing as specified in paragraph 3 and shall be subject to EC surveillance as specified in
               paragraph 4.
          3.   Quality system
          3.1. The manufacturer shall lodge an application for assessment of his quality system with a notified
               body.
               The application shall include:
               — all relevant information for the product category envisaged,
               — the quality system's documentation,
               — an undertaking to carry out the obligations arising from the quality system as approved,
               — an undertaking to maintain the quality system as approved to ensure its continuing suitability and
                   effectiveness.
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          3.2. The quality system shall ensure compliance of the products with the requirements of the Directive that
               apply to them.
               All the elements, requirements and provisions adopted by the manufacturer shall be documented in a
               systematic and orderly manner in the form of written policies, procedures and instructions. This quality
               system documentation shall ensure a common understanding of the quality policies and procedures such as
               quality programmes, plans, manuals and records.
               It shall contain in particular an adequate description of:
               — the quality objects and the organizational structure, responsibilities and powers of the management
                   with regard to design and product quality,
               — the technical design specifications including harmonized standards and technical regulations laid down
                   in Article 5,
               — the design control and design verification techniques, processes and systematic actions that will be used
                   when designing the products pertaining to the product category covered,
               — the corresponding manufacturing, quality control and quality assurance techniques, processes and
                   systematic actions that will be used,
               — the examination and tests that will be carried out before, during, and after manufacture, and the
                   frequency with which they will be carried out,
               — the means by which it is ensured that the test and examination facilities respect the requirements for
                   notified bodies designated for testing,
               — the means to monitor the achievement of the required design and product quality and the effective
                   operation of the quality system.
          3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred
               to in paragraph 3.2. It shall presume compliance with these requirements in respect of quality systems that
               implement the relevant harmonized standard (i.e. EN 29001).
               The assessment team shall have at least one member experienced as an assessor in the product technology
               concerned. The evaluation procedure shall include an assessment visit to the manufacturer's premises.
               The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the
               examination and the reasoned assessment decision.
          3.4. The manufacturer or his authorized representative shall keep the notified body that has approved the
               quality system informed of any intended updating of the quality system.
               The notified body shall evaluate the modifications proposed and decide whether the amended quality
               system will still satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is
               required.
               It shall notify its decision to the manufacturer. The notification shall contain the conclusion of the
               examination and the reasoned assessment decision.
          4.   EC surveillance
          4.1. The purpose of EC surveillance is to make sure that the manufacturer duly fulfils the obligations arising out
               of the approved quality system.
          4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of design,
               manufacture, inspection and testing, and storage, and shall provide it with all necessary information, in
               particular:
               — the quality system documentation,
               — the quality records as foreseen by the design part of the quality system, such as results of analyses,
                   calculations, tests, etc.,
               — the quality records as foreseen by the manufacturing part of the quality system, such as inspection
                   reports and test data, calibration data, qualification reports of the personnel concerned, etc.
          4.3. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and
               applies the quality system and shall provide an audit report to the manufacturer.
          4.4. Additionally the notified body may pay unexpected visits to the manufacturer. During such visits full or
               reduced audits may be carried out by the notified body. The notified body shall provide a visit report and, if
               applicable, an audit report to the manufacturer.
 ---pagebreak--- No C 187/50                                 Official Journal of the European Communities                                           27. 7. 90
          5.       Each notified body shall publish periodically the relevant information concerning the quality system
                    approvals issued and withdrawn.
          6.       Design examination
           6.1.    The manufacturer shall lodge an application for examination of the design with a notified body.
           6.2.     The application shall enable understanding of the design, manufacture and operation of the product, and
                    shall enable assessment of conformity with the relevant requirements of the Directive.
                    It shall include:
                    — the technical design specifications, including harmonized standards and technical regulations laid
                        down in Article 5 that have been applied,
                    — the necessary supporting evidence for their adequacy. This supporting evidence shall include the results
                        of tests carried out by an in-house notified body designated for testing or on behalf of the manufacturer
                        by a notified body designated for testing.
           6.3.     The notified body shall examine the application and where the design meets the provisions of the Directive
                    that apply to it shall issue an EC design examination certificate to the applicant. The certificate shall
                    contain the conclusions of the examination, conditions for its validity, the necessary data for identification
                    of the approved design and, if relevant, a description of the product's functioning.
           6.4.     The applicant shall keep the notified body that has issued the EC design examination certificate informed of
                    any modification to the approved design. Modifications to the approved design must receive additional
                    approval from the notified body that issued the EC examination certificate where such changes may affect
                    the conformity with the essential requirements of the Directive or the prescribed conditions for use of the
                    product. This additional approval is given in the form of an addition to the original EC design examination
                    certificate.
           6.5.     The notified bodies shall publish periodically the relevant information concerning:
                    — the applications for EC design examination received,
                    — the EC design examination certificates and additions issued,
                    — the EC design examination certificates and additions reissued,
                    — the EC design examination certificates and additions refused,
                    — the EC design approvals and additional approvals withdrawn.
                                                                   ANNEX 5
           MINIMUM CRITERIA T O BE TAKEN INTO ACCOUNT BY MEMBER STATES WHEN APPOINTING
                                                             NOTIFIED BODIES
           1. The notified body, its director and 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 equipment, nor the
                authorized representative of any of such parties. They shall not become directly involved in the design,
                construction, marketing or maintenance of terminal 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 tests or
                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.
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          4. The staff responsible for tests or inspections must have:
             — sound technical and professional training,
             — satisfactory knowledge of the requirements of the tests or inspections they carry 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
                 test or inspections.
          5. The impartiality of test and 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 tests or inspections.
          6. The notified body must take out liability insurance unless its liability is assumed by the 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-a-vis the competent administrative authorities of the State in which its
             activities are carried out) under this Directive or any provision of national law giving effect to it.
                                                             ANNEX      6