CELEX: 51993PC0322
Language: en
Date: 1993-10-14
Title: Proposal for a COUNCIL DIRECTIVE on articles of precious metal

25 . 11 . 93                         Official Journal of the European Communities                                 No C 318 / 5
                                                               II
                                                      (Preparatory Acts)
                                                COMMISSION
                              Proposal for a Council Directive on articles of precious metal
                                                        (93 / C 318 / 06)
                                              COM(93) 322 final — SYN 472
                                    (Submitted by the Commission on 18 October 1993)
 THE COUNCIL OF THE EUROPEAN UNION,                                 approach to technical harmonization and standards (')
                                                                    and those dictated by the principle of subsidiarity, rules
 Having regard to the Treaty establishing the European              on articles of precious metal should be confined to
 Community, and in particular Article 100a thereof,                 essential requirements ; whereas these requirements must
                                                                    replace the corresponding national provisions ;
 Having regard to the proposal from the Commission,
                                                                   Whereas harmonized standards would be useful in estab­
 In cooperation with the European Parliament,                       lishing a presumption of conformity with the essential
                                                                   requirements and with other provisions ; whereas, at
Having regard to the opinion of the Economic and                    Community level, such harmonized standards are drawn
 Social Committee,                                                 up by bodies governed by private law and must retain
                                                                   their status of non-compulsory texts ; whereas, to this
Whereas it is important that measures be adopted for the           end, the European Committee for Standardization
gradual establishment of the internal market; whereas               (CEN) and the European Committee for Electro­
the internal market is an area free of internal frontiers in       technical Standardization (Cenelec) are recognized as
which goods, persons, services and capital can move                the bodies competent to adopt harmonized standards in
 freely;                                                           accordance with the general guidelines on cooperation
                                                                   between those bodies and the Commission signed on 13
Whereas the national technical rules applying to articles          November 1984 ;
of precious metal have raised barriers to the free
movement of goods ;                                                Whereas, in confirming the appeal of international stan­
                                                                   dardization which generates standards that are in
Whereas, in compliance with the principle of subsi­                practice applied by all partners in international trade and
diarity, the Community becomes involved only if the                which meets the requirements of Community policy, the
aims of a proposed measure cannot adequately be                    Community invites the European standardization bodies
achieved by means of action at Member-State level and              to continue their cooperation with the international stan­
may thus be better achieved by action at Community                 dardization organizations ;
level ;
                                                                   Whereas ,    for the purposes          of this Directive,   a
Whereas certain aspects of the sector must therefore be            harmonized      standard     is   a technical   specification
harmonized in order to remove those barriers and ensure            (European standard or harmonization document)
the free movement of articles of precious metal within             adopted by one or both of these bodies on a mandate
the Community ;                                                    from the      Commission      in  accordance with   Council
                                                                   Directive 83 / 189/EEC of 28 March 1983 laying down a
Whereas the means and measures implemented by the                  procedure for the provision of information in the field of
Community are proportional to the aim pursued and                  technical standards and regulations (2), as last amended
must thus be restricted to the essential requirements ;            by Directive 88 / 182/EEC (3), and by virtue of the
whereas those requirements must replace the corres­                abovementioned guidelines ; whereas, as regards any
ponding national provisions ;                                      amendments to harmonized standards, the Commission
                                                                   should be assisted by the standing committee set up by
Whereas an appropriate level of consumer protection                Directive 83 / 189/EEC ;
and fair trading need to be ensured in the field of articles
of precious metal ;
                                                                   O OJ No C 136, 4. 6. 1985 , p. 1 .
Whereas, in accordance with the principles laid down in            (2) OJ No L 109, 26 . 4 . 1983, p. 8 .
the Council resolution of 7 May 1985 on a new                      O OJ No L 81 , 26. 3 . 1988 , p. 75 .
 ---pagebreak---  No C 318 /6                            Official Journal of the European Communities                                 25 . 11 . 93
Whereas manufacturers shall have the option of applying           HAS ADOPTED THIS DIRECTIVE :
 one of the conformity attestation procedures foreseen by
 this Directive and may call upon one of the certification                                   CHAPTER I
 bodies amongst those published by the Commission ;                    Scope, placing on the market and free movement
whereas Member States must accept products that have
 satisfied one of the certification procedures foreseen by                                     Article 1
 this Directive ; whereas these means should be based on
the provisions of Council Decision 90 /683 /EEC (') and            1 . This Directive covers provisions relating to indi­
 ensure a level of quality sufficient to meet the needs of        cation of the standard of fineness of articles of precious
 those responsible for placing articles on the Community          metal, finished or semi-finished, intended for the
 market ; whereas, therefore, these means must always             ultimate consumer.
 involve checks by a notified body; whereas the notifi­
cation of a certification body is an option open to               2.       For the purposes of this Directive :
 Member States, their duty being to ensure that the
notified body meets the assessment criteria laid down in            a    precious metals are platinum, gold, palladium and
this Directive ;                                                         silver in the pure state and their alloys ;
                                                                   (b) an article of precious metal is any item of jewellery,
                                                                         goldsmith's ware or watchmaker's ware and any
Whereas articles must, as a general rule, be struck with a               other object made entirely or in part from a
fineness mark and a sponsor's mark; whereas the                          precious metal ;
fineness mark indicates that they comply with the
provisions of this Directive ; whereas there is therefore no      (c) an article comprising various precious metals is any
need for those products to bear the CE marking ;                         item of jewellery, goldsmith's ware or watchmaker's
whereas the sponsor's mark, registered in the Member                    ware and any other object made entirely or in part
States in the interests of decentralized management, must                from various precious metals ;
make it possible to identify the person responsible for           (d) a mixed article is an article comprising parts of
placing the article concerned on the market ; whereas,                  precious metal and parts of base metal or other
where marking is technically difficult, articles must be                 substances ;
accompanied by a certificate ;
                                                                  (e) an alloy of a precious metal is a solid solution of a
                                                                        precious metal and one or more other metals ;
Whereas, to ensure the transparency of the market, the            (f) standard of fineness is the fine precious-metal
number of standards which may be used for each                          content expressed in parts per thousand in relation
precious metal should be restricted ; whereas it would                  to the total mass of the alloy concerned ;
therefore be expedient to take account of existing inter­
national standards and of practices in the Member                 (g) the nominal standard of fineness is the standard of
States ;                                                                fineness of the alloy shown by a punched mark on
                                                                        the article or entered on the Community certificate
                                                                        of conformity ;
Whereas a distinctive sign has been laid down for each            (h) a precious metal coating is a coat of precious metal
precious metal in order that the type of metal used may                 applied to all or part of an object by a chemical,
be identified ; whereas the sponsor's mark must be                      electrochemical, mechanical or physical process ;
accompanied by a small letter 'e', identifying articles           (0    the manufacturer is the person who assumes respon­
which comply with the provisions of this Directive ;                    sibility for the manufacture of the articles which he
                                                                        places on the Community market under his own
                                                                        name, and for their compliance with the applicable
Whereas information given in marks is in coded form ;                   provisions ;
whereas, accordingly, Member States need to take
appropriate steps to provide clear information to the             0)    the importer is the person who places a qualifying
purchaser at the point of ultimate sale ;                               article from a third country on the Community
                                                                        market ;
                                                                  (k) the authorized representative is the natural or legal
Whereas there should be a transitional period for the                   person established within the Community who,
disposal of stocks of articles manufactured in accordance               explicitly designated by the manufacturer, acts on
with national rules in force on the date of adoption of                 behalf of the latter in performing duly defined tasks ;
the Directive ,
                                                                  (1)   the person responsible for placing articles on the
                                                                        market is any natural or legal person established
                                                                        within the Cortimunity who assumes responsibility
                                                                        for the conformity with the applicable provisions of
                                                                        the articles which he places on the Community
O OJ No L 380 , 31 . 12 . 1990, p. 13 .                                 market under his own name ;
 ---pagebreak---   25 . 11 . 93                           Official Journal of the European Communities                                 No C 318 / 7
  (m) placing on the market is the first time that an article                                    Article 5
        is made available on the Community market
        whether by way of payment or free of charge, with            1 . Member States shall presume articles to conform to
        a view to distribution and /or use on Community             this Directive if they satisfy the relevant provisions of the
        territory ;                                                 national standards which transpose the harmonized
                                                                    standards whose references shall be published in the
  (n) the sponsor's mark is the mark identifying, on the             Official Journal of the European Communities.
        one hand, the manufacturer or person responsible
        for placing articles on the market and, on the other,
        the notified body which has checked the conformity          2 . Member States shall publish the references to the
        of an article ;                                             national standards transposing the harmonized standards
                                                                    referred to in paragraph 1 ,
 (o) the fineness mark is the mark indicating the nominal
        standard of fineness of the precious metal, set
        within the appropriate surround ;                                                       Article 6
 (p) a notified body : a body responsible for carrying out          Where a Member State or the Commission considers
        the conformity assessment procedures .                      that the standards referred to in Article 5 ( 1 ) do not
                                                                    afford conformity with the corresponding provisions of
 3.      This Directive does not apply to :                         this Directive, the Commission or the Member State
 (a) articles of precious metal for dental prostheses or            concerned shall bring this to the attention of the
        for medical use, as defined in Council Directive            committee set up by Directive 83 / 189 /EEC , hereinafter
        93 /42 /EEC (»);                                            referred to as 'the Committee', setting out the reasons.
                                                                    The Committee shall give an opinion as a matter of
 (b) objects of precious metal for scientific or technical          urgency.
        use ;
 (c) musical instruments or parts of such instruments              The Commission shall, in the light of the Committee's
        made from precious metal ;                                  opinion, notify the Member States as to whether or not
                                                                   the standards in question must be withdrawn from the
 (d) legal tender made of precious metal and collectors'           publications referred to in Article 5 (2).
       coins and medals ;
 (e) ingots or granules of precious metal for banking                                           Article 7
       use ;
 (f) objects made of metals other than precious metal               1.     Where a Member State finds that articles bearing
                                                                   the fineness mark referred to in Article 1 1 or accom­
       and coated with precious metal.
                                                                   panied by the Community certificate of conformity
 4. Articles made of precious metal or comprising                  referred to in Article 13 (3) do not correspond to the
various precious metals, finished or semi-finished, are            provisions of this Directive it shall take all appropriate
 hereinafter referred to as ' articles'.                           measures to withdraw those articles from the market or
                                                                   to prohibit or restrict their being placed on the market.
                             Article 2
                                                                   The Member State              concerned shall inform the
Member States shall adopt all provisions to ensure that,           Commission of such           measures forthwith and shall
with regard to indication of the standard of fineness,
only articles complying with this Directive may be placed          indicate the reasons for its decision and, in particular,
on the market.                                                     whether the non-conformity results from :
                             Article 3                             (a) non-compliance with the essential requirements
                                                                        referred to in Article 3 , where the standards referred
Articles must satisfy the essential requirements which                  to in Article 5 ( 1 ) have not been applied ;
apply to them . Those requirements are set out in Annex
II .
                                                                   (b) incorrect application of the standards referred to in
                                                                        Article 5(1 );
                            Article 4
Member States may not, with regard to the indication of            (c) shortcomings in the standards referred to in Article 5
the standard of fineness, prohibit, restrict or hinder the              ( 1 ).
placing on the market of articles which bear the marks
referred to in Articles 10 and 11 or which are accom­
panied by the Community certificate of conformity                  2.     The Commission shall consult the parties concerned
referred to in Article 13 (3).                                     as soon as possible . Where the Commission, after consul­
                                                                  tation, finds that the measures referred to in paragraph 1
                                                                  are justified, it shall forthwith inform the Member State
(') OJ No L 169, 12 . 7. 1993, p. 1 .                             which took the measures and the other Member States .
 ---pagebreak--- No C 318 / 8                          Official Journal of the European Communities                                25 . 11 . 93
Where the decision referred to in paragraph 1 is                                           Article 9
attributed to shortcomings in the standards, the
Commission shall, after consulting the parties concerned,        1 . Member States shall notify to the other Member
refer the matter to the Committee within a period of two         States and to the Commission the bodies responsible for
months if the Member State which took the measures              carrying out the procedures referred to in Article 8 and
intends to maintain them , and shall initiate the procedure     their specific tasks in the matter.
referred to in Article 6 .
                                                                The Commission shall publish in the Official Journal of
Where the Commission finds , after consultation, that the        the European Communities, for information, the list of
measure is unjustified it shall forthwith inform the             notified bodies and the tasks for which they have been
Member State which took the initiative thereof, as well          notified . The Commission shall be responsible for
as the manufacturer or his authorized representative or          updating this list.
the person responsible for placing goods on the market.
                                                                 2 . Member States which designate certification bodies
3 . The Member State concerned shall take the appro­             to implement the procedures specified in Article 8 shall
priate measures against any person who has improperly            apply the criteria set out in Annex VI for the designation
affixed the fineness mark or drawn up the Community              of those bodies . Bodies which meet the assessment
certificate of conformity and shall inform the                   criteria laid down in the national standards which
Commission and the other Member States thereof.
                                                                 transpose the relevant harmonized standards shall be
                                                                 presumed to satisfy the criteria which apply to them .
4.     The Commission shall ensure that the Member
States are kept informed of the progress and outcome of
the procedure .                                                  3 . A Member State which has notified a body must
                                                                 withdraw that notification if it finds that the body in
                                                                 question no longer satisfies the criteria referred to in
                       CHAPTER II                                paragraph 2 . It shall forthwith inform the other Member
                                                                 States and the Commission thereof.
              Conformity attestation procedures
                           Article 8                             4 . Without prejudice to Articles 4 and 8 , Member
                                                                 States are not obliged to set up on their territory the
 1 . Before placing them on the market, the manu­                procedures specified in Article 8 .
facturer or his authorized representative must ensure the
conformity of the articles. In order to do so he has the
option of :                                                                              CHAPTER III
(a) following the procedure for the Community                                              Marking
     declaration of conformity based on a system of
     product quality assurance as referred to in Annex                                     Article 10
     III ; or                                                    1.    Articles must be struck with the sponsor's mark
(b) following the procedure for the Community                    before being placed on the market. This mark shall be
     declaration of conformity referred to in Annex IV ;         accompanied by a small letter £e\
     or
                                                                 2.    The manufacturer or the person responsible for
(c) submitting the articles for verification as referred to      placing the articles on the market must apply to a
     in Annex V.                                                 Member State for his sponsor's mark to be registered
                                                                 and must, where appropriate, communicate to it the
2 . The conformity assessment procedure referred to in           decision referred to in point 3.3 of Annex III .
Annex V may also be requested by the person
responsible for placing the articles on the market.
                                                                 3 . Member States must register the sponsor's mark
                                                                 and make sure, in collaboration with the applicant, that
3 . The manufacturer, his authorized representative or,          there is an unequivocal correspondence between that
where appropriate, the person responsible for placing            mark and the applicant.
articles on the market shall select a notified body from
amongst those notified pursuant to Article 9 to carry out
the checks prescribed in whichever conformity                    Registration of the sponsor's mark must make it possible
assessment procedure is used.                                    to identify the applicant, the notified body chosen by the
                                                                 applicant to implement the procedures referred to in
                                                                 Article 8 , the conformity procedure applied and the date
4 . The dossiers and correspondence relating to the              of registration .
conformity assessment procedures referred to in
paragraph 1 shall be written in an official language of
the Member State in which the notified body is estab­            4 . Data relating to the registration of sponsor's marks
lished or in a language accepted by that body.                   shall be made available by the Member States .
 ---pagebreak---  25 . 11 . 93                             Official Journal of the European Communities                              No C 318 / 9
                           Article 11                                                        CHAPTER IV
 Articles deemed to satisfy the essential requirements                                         Labelling
 referred to in Article 3 must, prior to being placed on the
 market, be struck with one or more fineness marks by                                          Article 15
 the manufacturer or, where appropriate, by his auth­
 orized representative, the person responsible for placing           Member States shall take the appropriate measures to
 on the market or the notified body which carried out the            ensure that purchasers are provided with proper infor­
 varification referred to in Article V.                              mation at the place of sale to the ultimate consumer
                                                                     regarding the standard of fineness of articles, particularly
                                                                     where, in accordance with Article 13 , articles do not
 The specific surrounds to be used for each precious                 bear marks .
 metal, within which the standard of fineness as set out in
 Annex I must be indicated, are set out in Annex VII .
                                                                                             CHAPTER V
                           Article 12                                                      Final provisions
 1.    The    informative     content  of the    fineness  and                                Article 16
 sponsor's marks and the letter V must be visible, legible
 and durable and at least 0,5 mm high.                               1.    Precise grounds must be given for any decision
                                                                     relating to the indication of standards of fineness taken
                                                                     by virtue of this Directive which results in articles of
 2 . Existing traditional marks may also be struck on                precious metal being withdrawn from the market or in a
 articles as long as they do not lead to confusion with              ban or restriction being applied to their being placed on
 fineness marks or sponsor's marks or the letter V.                  the market.
                           Article 13                                2 . The decision shall be notified to the party
                                                                     concerned as soon as possible, together with an indi­
 1 . The obligation to strike fineness marks , sponsor's             cation of the means of appeal available under the laws in
 marks and the letter £e' shall not apply in respect of :            force in the Member State in question and the period
                                                                    within which such appeal must be made.
     small articles or those which are too fragile upon
     which it is technically difficult to strike marks,                                       Article 17
     semi-finished articles .                                        1 . Member States shall adopt and publish the laws,
                                                                    regulations and administrative provisions necesarry to
                                                                    comply with this Directive by 30 June 1995 at the latest.
2 . The obligation to strike the fineness mark shall not            They shall forthwith inform the Commission thereof.
apply in respect of those parts of articles consisting of
various precious metals upon which it is technically                When Member States adopt these provisions , these shall
difficult to strike such a mark.                                    contain a reference to this Directive or shall be accom­
                                                                    panied by such reference at the time of their official
                                                                    publication. The procedure for such reference shall be
3 . The articles referred to in paragraphs 1 and 2 must             adopted by Member States .
be accompanied by a Community certificate of
conformity issued by the manufacturer, or where appro­              Member States shall apply these provisions from 1
priate, by his authorized representative, the person                January 1996 .
responsible for placing on the market or the notified
body which carried out the verification referred to in              2.     Member     States    shall   communicate    to    the
Annex V. The information to be given on the certificate             Commission the text of the provisions of national law
is set out in Annex VIII .                                          which they adopt in the field covered by this Directive.
                          Article 14                                2 . Member States shall, for the period up to 1 January
                                                                    1998 , authorize the placing on the market of articles of
Where it is found that a fineness mark has been affixed             precious metal which are in conformity with the rules in
improperly or that a Community certificate of                       force on their territory on the date of adoption of this
conformity has been issued improperly, the notified body            Directive .
which checked the conformity shall take the necessary
measures and shall forthwith inform the Member State
                                                                                              Article 18
concerned thereof. The latter shall inform the other
Member States and the Commission thereof.                          This Directive is addressed to the Member States
 ---pagebreak--- No C 318 / 10                               Official Journal of the European Communities                               25. 11 . 93
                                                               ANNEX I
                       NOMINAL STANDARDS OF FINENESS FOR ARTICLES OF PRECIOUS METAL
                                                                                        Nominal fineness
                            Precious metals and their alloys
                                                                                      (parts per thousand)
            Gold                                                                               333
                                                                                              375
                                                                                              500
                                                                                              585
                                                                                              750
                                                                                              800
                                                                                              840
                                                                                              916
                                                                                              990
                                                                                              999
            Platinum                                                                          850
                                                                                              900
                                                                                              950
                                                                                              999
            Palladium                                                                         500
                                                                                              950
                                                                                              999
            Silver                                                                            800
                                                                                              835
                                                                                              925
                                                                                              999
                                                              ANNEX II
                                                      ESSENTIAL REQUIREMENTS
            1.   Articles of precious metal covered by this Directive must be manufactured and marked in such a way
                  as to minimize the risk to consumers of confusion or fraud in respect of the precious metal content.
           2.    Articles must bear a fineness mark or, in the cases referred to in Article 13 , be accompanied by a
                 Community certificate of conformity indicating a nominal standard of fineness corresponding to one
                 of the standards set out in Annex I.
                 The standard of fineness of precious metals must be expressed in parts per thousand.
           3.    Marking and certificates
           3.1 . Articles of a single precious metal must bear a fineness mark.
           3.2 . Articles comprising various precious metals must bear the relevant fineness mark on each part.
           3.3 . Mixed articles must bear the corresponding fineness mark on the part made of precious metal or of
                 various precious metals.
                 Parts made of non-precious metal must be easily recognizable or clearly identified.
           3.4. In the cases provided for in Article 13 ( 1 ) and (2), articles must be accompanied by a Community
                 certificate of conformity.
           4.    Articles of precious metal, where coated with other metals, must bear the fineness mark of the base
                 precious metal alloy. They must also bear an indication of the type of coating or be accompanied by a
                 document giving that information where it cannot be indicated on the article.
 ---pagebreak--- 25 . 11 . 93                                 Official Journal of the European Communities                                    No C 318 / 11
             5.     No negative tolerance is permissible in relation to the nominal standard of fineness . Thus a given
                    precious metal alloy in an article must, with the exception of the solder, have a standard of fineness at
                    least equal to that indicated .
             6.     Precious metals in an article must be soldered using an alloy of the same standard of fineness and of
                   the same precious metal as the rest of the article. Where this is technically not possible, soldering may
                   be carried out using an alloy of a lower standard of fineness or another material,
             7.     Mechanisms or elements made of non-precious metal may be used to satisfy essential technical
                    requirements. Where they are visible, such mechanisms must be easily recognizable or clearly ident­
                    ified .
                                                                  ANNEX III
                                                    PRODUCT QUALITY ASSURANCE
             1.    The manufacturer shall operate the approved quality system for final product control as specified in
                   point 3 and shall be subject to inspection as specified in point 4 .
             2.    (a) The manufacturer shall meet the obligations set out in point 1 and shall ensure and make a
                         declaration to the effect that the articles concerned satisfy the provisions of this Directive which
                         apply to them .
                         The manufacturer shall strike upon the articles the fineness mark, within the surrounds set out in
                         Annex VII, and the registered sponsor's mark, together with the letter 'e' and shall, where appro­
                         priate, draw up a Community certificate of conformity.
                   (b) The manufacturer shall draw up such technical documentation as to permit the conformity of the
                         articles with the requirements of the Directive to be assessed.
                         This documentation shall include :
                         — a list of the standards referred to in Article 5 which are applied ,
                         — the means employed to ensure the quality of the alloys used,
                         — where appropriate, the soldering methods.
                         The manufacturer or his authorized representative shall keep this documentation available for
                         inspection by the national authorities for as long as the decision referred to in points 3.3 and 3.4
                         remains valid .
             3.    Quality system
             3.1 . The manufacturer shall lodge an application for the assessment of his quality system for the articles
                   concerned with a single notified body of his choice.
                   The application shall include :
                   — all appropriate information on the articles,
                   — the documentation relating to the quality system,
                   — an undertaking to discharge the obligations arising from the quality system as approved,
                   — an undertaking to maintain the approved quality system in such a way that it remains appropriate
                        and effective .
             3.2 . The quality system must ensure that the articles conform to the requirements of the Directive which
                   apply to them.
                   All provisions adopted by the manufacturer must be documented in a systematic and orderly manner
                   in the form of written measures, 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 a proper description of :
                   — the quality objectives,
                   — the examinations and tests which will be carried out,
                   — the means of monitoring the effective operation of the quality system,
                   — the quality records.
 ---pagebreak--- No C 318 / 12                              Official Journal of the European Communities                                      25 . 11 , 93
            3.3 . The notified body shall audit the quality system to determine whether it satisfies the requirements
                  referred to in point 3.2 . It shall presume conformity with these requirements in respect of quality
                  systems which implement the relevant harmonized standard.
                  The auditing team shall include at least one member with experience in assessing the technology
                  concerned. The assessment procedure shall include a visit to the manufacturer's premises.
                  The decision shall be notified to the manufacturer. It shall contain the conclusions of the examination
                  and the reasoned assessment.
            3.4. The manufacturer shall inform the notified body which approved the quality system of any plan to
                  introduce changes in the quality system.
                  The notified body shall assess the proposed modifications and determine whether the modified quality
                  system will still satisfy the requirements referred to in point 3.2 or whether a reassessment is required.
                  It shall notify its decision to the manufacturer. The notification shall contain, where appropriate, the
                  conclusions of the examination and the reasoned assessment decision .
            4.    Inspection
            4.1 . The purpose of inspection 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 access for inspection purposes to the places of
                  inspection, testing and storage and shall provide it with all the appropriate information.
            4.3 . The notified body shall periodically carry out audits to ensure that the manufacturer is applying the
                  quality system and shall provide an audit report to the manufacturer.
            5.    Administrative provisions
            5.1 . The manufacturer shall keep the following at the disposal of the national authorities :
                  — the documentation referred to in point 3.1 ,
                  — the documentation on the changes referred to in point 3.4,
                  — the decisions and reports from the notified body which are referred to in points 3.3, 3.4 and 4.3 .
            5.2 . Each notified body shall forward to the other notified bodies any relevant information concerning the
                  issue and withdrawal of quality system approvals.
                                                                ANNEX IV
                                         COMMUNITY DECLARATION OF CONFORMITY
            1 . The manufacturer, or his authorized representative, who carries out the obligations laid down in point 2
                shall ensure and make a declaration to the effect that the articles concerned satisfy the requirements of
                the Directive which apply to them.
                The manufacturer or his authorized representative shall strike upon the articles the fineness mark,
                within the surrounds referred to in Annex VII, and the registered sponsor's mark together with the
                letter 'e' or shall, where appropriate, draw up a Community certificate of conformity.
            2 . The manufacturer shall draw up such technical documentation as to permit the conformity of the
                product with the requirements of the Directive to be assessed.
                This documentation shall include :
                — a list of the standards referred to in Article 5 which are applied,
                — the means employed to ensure the quality of the alloys used,
                — where appropriate, the soldering methods.
                The manufacturer or his authorized representative shall keep this documentation available for inspection
                by the national authorities.
                Where neither the manufacturer nor his authorized representative is established within the Community,
                the obligation to keep the technical documentation available shall fall to the person responsible for
                placing the article on the market.
 ---pagebreak--- 25 . 11 . 93                                Official Journal of the European Communities                                      No C 318 / 13
             3 . The manufacturer shall take all measures necessary in order that the manufacturing process shall ensure
                 compliance of the manufactured articles with the technical documentation referred to in point 2 and
                 with the requirements of the Directive which apply to them.
             4. A notified body chosen by the manufacturer shall carry out or have carried out product checks at
                 random intervals. An appropriate sample of the finished articles, 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 , or
                 equivalent tests, shall be carried out to check the conformity of the articles with the requirements of the
                 Directive.
                 In those cases where one or more of the articles checked does not conform, the notified body shall take
                 appropriate measures.
                                                                 ANNEX V
                                                    THIRD PARTY VERIFICATION
             1.    Verification is the act by which a notified body checks and attests that articles satisfy the essential
                   requirements set out in this Directive which apply to them.
             2.    Verification may be carried out either by examination and testing of every product as specified in
                   point 3 or by examination and testing of products on a statistical basis as specified in point 4, at the
                   choice of the manufacturer or the person responsible for placing on the market.
             3.    Verification by examination and testing of every product
             3.1 . Each product bearing the registered sponsor's mark together with the letter 'e' shall be examined and
                   appropriate tests as set out in the relevant standards referred to in Article 5 , or equivalent tests, shall
                   be carried out in order to verify its conformity with the essential requirements of the Directive which
                   apply to it.
             3.2. The notified body shall strike the fineness mark, within the surrounds set out in Annex VII, upon each
                   approved article or shall, where appropriate, draw up a Community certificate of conformity.
             4.    Statistical verification
             4.1 . Having taken all the measures necessary to ensure the homogeneity of each lot, the manufacturer, his
                   authorized representative or the person responsible for placing on the market shall present his articles
                   in the form of homogeneous lots already bearing the registered sponsor's mark together with the letter
                   ' e\
             4.2 . The notified body shall strike the fineness mark, within the surrounds set out in Annex VII, upon each
                   article in the accepted lot or shall, where appropriate, draw up a Community certificate of conformity
                   for each accepted article or for several articles, duly identified.
             4.3 . Articles shall be submitted for statistical checking by essential characteristics. They shall be grouped in
                   identifiable lots and each lot shall be checked. The articles in a sample shall be individually examined
                   and appropriate tests as set out in the relevant standard(s) referred to in Article 5, or equivalent tests,
                   shall be carried out in order to determine whether the lot is accepted or rejected.
                   A sampling plan with the following operational characteristics shall be applied :
                   — a standard quality level corresponding to a 95 % probability of acceptance with a non-conformity
                        percentage of less than 1 % ,
                   — a limit quality corresponding to a 5 °/o probability of acceptance with a non-conformity percentage
                        of less than 5 % .
             4.4 . If a lot is rejected, the notified body shall take appropriate measures to prevent the placing on the
                   market of that lot. In the event of frequent rejection of lots the notified body may suspend the stat­
                   istical verification .
 ---pagebreak--- No C 318 / 14                             Official Journal of the European Communities                                    25 . 11 . 93
                                                                ANNEX VI
                          CRITERIA FOR THE ASSESSMENT OF THE BODIES TO BE NOTIFIED
            Bodies designated by Member States must satisfy the following conditions :
            — availability of staff and of the necessary means and equipment,
            — technical competence and professional integrity of the staff,
            — in carrying out tests, drafting reports, issuing attestations and carrying out inspections in accordance
                 with this Directive, the management and technical staff must be independent of all circles, groupings or
                 persons with a direct or indirect interest in the area concerned,
            — staff must be bound by professional secrecy,
            — third party insurance must be taken out unless such liability is covered by the State under national law.
            The conditions referred to in the first two indents above shall be periodically checked by the competent
            authorities of the Member States or by bodies designated by the Member States.
                                                               ANNEX VII
                                                  FINENESS MARK SURROUNDS
            I. The surrounds specific to each precious metal and which must surround the standard of fineness of the
                precious metals and their alloys set out in Annex I are given below :
                  GOLD                          SILVER                       PLATINUM                    PALLADIUM
            2 . The standard of fineness must be indicated within these surrounds along the axis of the dashes.
                                                               ANNEX VIII
                              CONTENTS OF COMMUNITY CERTIFICATE OF CONFORMITY
            The Community certificate of conformity must be drawn up in an official language of the Member State in
            which the articles are marketed and must include the following :
            — name and address of the manufacturer or his authorized representative or the person responsible for
                placing on the market,
            — the letter 'e',
            — a description of the article or of the semi-finished articles,
            — the standard of fineness in parts per thousand of the precious metal or precious metals concerned,
            — the name and address of the notified body involved in the conformity attestation procedures referred to
                in Article 8 and the procedure applied.