CELEX: 51992PC0499(01)
Language: en
Date: 1992-12-07
Title: Proposal for a Council Directive amending Council Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non- automatic weighing instruments), 90/385/EEC (active implantable medical devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels), and 73/23/EEC (electrical equipment designed for use within certain voltage limits)

No C 28 / 16                                   Official Journal of the European Communities                                         2 . 2 . 93
                     MODIFICATION            OF   THE     PROPOSAL         FOR        A    COUNCIL         REGULATION       ( EEC )
                     CONCERNING THE AFFIXING AND USE OF THE CE MARK OF CONFORMITY ON
                     INDUSTRIAL PRODUCTS H IN A PROPOSAL FOR A COUNCIL DIRECTIVE AND A
                                                  PROPOSAL FOR A COUNCIL DECISION
                     Proposal for a Council Directive amending Council Directives 87 / 404 / EEC ( simple pressure
                     vessels ), 88 / 378 / EEC ( safety of toys ), 89 / 106 / EEC ( construction products), 89 / 336 / EEC
                     ( electromagnetic compatibility ), 89 / 392 / EEC ( machinery ), 89 / 686 / EEC ( personal protective
                     equipment ), 90 / 384 / EEC ( non-automatic weighing instruments ), 90 / 385 / EEC ( active
                     implantable medical devices ), 90 / 396 / EEC ( appliances burning gaseous fuels ), 91 / 263 / EEC
                     ( telecommunications terminal equipment ), 92 / 42 / EEC ( new hot-water boilers fired with liquid or
                     gaseous fuels ), and 73 / 23 / EEC ( electrical equipment designed for use within certain voltage
                                                                        limits )
                                                                  ( 93 / C 28 / 02 )
                                                                     and into a
                                                       COM(92 ) 499 final — SYN 336 A
                     (Submitted by the Commission to the Council on 7 December 1992 pursuant to Article 149 (3 ) of
                                                                the EEC Treaty)
  THE COUNCIL OF THE EUROPEAN COMMUNITIES ,                                      Whereas the two basic elements of the new approach
                                                                                 which must be applied are therefore the essential
  Having regard to the Treaty establishing the European                          requirements and the conformity assessment procedures ;
  Economic Community , and in particular Article 100a
 thereof,                                                                        Whereas this harmonization of the provisions concerning
                                                                                 the affixing and use of the CE marking requires that
 Having regard to the proposal from the Commission in                            existing directives undergo detailed amendment to bring
 cooperation with the European Parliament ,                                      them into line with the new arrangements ;
 Having regard to the opinion of the Economic and Social
 Committee ,                                                                     HAS ADOPTED THIS DIRECTIVE :
 Whereas the Council has already adopted several directives
 designed to remove technical barriers to trade on the basis
                                                                                                              Article 1
 of Article 100a of the Treaty and in accordance with the
 principles established in its Resolution of 7 May 1985
 on a new approach to technical harmonization and                               Directive 87 / 404 / EEC ( s ) on simple pressure vessels is
 standards ( 2 ); whereas each of these directives provides for                 hereby amended as follows :
 the affixing of the CE marking ; whereas , therefore , in the
 interests of simplifying Community legislation and making
                                                                                 1 . Throughout the text , 'EC mark' is replaced by 'CE
 it more consistent , these various provisions need to be
                                                                                      marking'.
 replaced by uniform prescriptions , particularly with regard
 to products which may fall withing the scope of several of
 these directives ;                                                             2 . Article 5 ( 1 ) is amended to read as follows :
                                                                                      '1 .   Member States shall presume that vessels
 Whereas , in its communication of 15 June 1989 on a
                                                                                      bearing the CE marking comply with all the provisions
 global approach to certification and testing ( 3 ), the                              of this Directive , including the conformity assessment
 Commission proposed that common rules be drawn up
                                                                                      procedures referred to in Chapter 2 .
 concerning a CE conformity marking with a single design ;
 whereas , in its Resolution of 21 December 1989 on a
global approach to conformity assessment ( 4 ), the Council                           Conformity of vessels with the national standards
 approved as a guiding principle the adoption of a                                   which transpose the harmonized standards the
consistent approach such as this with regard to the use of                            reference numbers of which have been published in the
the CE marking ;
                                                                                      Official Journal of The European Communities shall
                                                                                     result in a presumption of conformity with the
                                                                                     essential safety requirements referred to in Article 3 .
(>) OJ No C 195 , 1 . 8 . 1992 , p . 2 .                                             Member States shall publish the reference numbers of
( 2 ) OJ No C 136 , 4 . 6 . 1985 , p . 1 .
                                                                                      such national standards .';
H OJ No C 231 , 8 . 9 . 1989 , p . 3 , and OJ No C 267 , 19 . 10 .
      1989 , p . 3 .
( 4 ) OJ No C 10 , 16 . 1 . 1990 , p . 1 .                                     ( 5 ) OJ No L 220 , 8 . 8 . 1987 , p . 48 .
 ---pagebreak--- 2 . 2 . 93                                    Official Journal of the European Communities                                 No C 28 / 17
3 . The following paragraph 3 is added to Article 5 :                        the conformity of the product with the requirements of
                                                                             the Directive by examination and testing of products
      '3 , ( a ) Where the vessels are subject to other                      on a statistical basis , as specified in paragraph 4 .
                  directives covering other aspects and which
                  also provide for the affixing of the CE                    4.     Statistical verification
                  marking, the latter shall indicate that the
                  vessels in question are presumed to conform
                                                                             4.1      The manufacturer shall present his products in
                  to the provisions of those other directives .              the form of uniform batches and shall take all
           ( b ) However , should one or more of the directives              necessary measures in order that the manufacturing
                  which apply to the vessels allow the                       process ensure the uniformity of each batch
                  manufacturer , during a transitional period , to           produced .
                  choose which arrangements to apply , the CE
                  marking shall indicate conformity only with                4.2      These batches shall be accompanied by the EC
                  the directives applied by the manufacturer .               type-examination certificate referred to in Article 10 ,
                                                                             or , where the vessels are not manufactured in
           ( c) In this case , the particulars of the said                   accordance with an approved prototype , by the design
                  directives , as published in the Official Journal          and manufacturing schedule referred to in point 3 of
                  of the European Communities, must be given                 Annex II . In this case the approved body shall , prior
                  in the documents , notices or instructions                 to EC verification , examine the schedule in order to
                 required by the directives and accompanying                 certify its conformity .
                  such vessels .';
                                                                            4.3      When a batch is examined , the inspection body
4 . Article 9 ( 1 ) is amended to read as follows :                         shall ensure that the vessels have been manufactured
                                                                            and checked in accordance with the design and
     '1 .      Member States shall inform the Commission                    manufacturing schedule and perform a hydrostatic test
     and the other Member States of the approved bodies                     or a pneumatic test of equivalent effect on each vessel
     responsible for carrying out the certification                         in the batch at a pressure pH 1,5 times the vessel's
     procedures referred to in Article 8 ( 1 ) and ( 2 ) and of             design pressure in order to check its soundness . The
     the identification numbers assigned by the Commission                  pneumatic test shall be subject to acceptance of the test
     to the bodies involved in the production control phase .               safety procedures by the Member State in which the
     The Commission shall , for information , publish in the                test is performed .
     Official Journal of the European Communities a list of
     these bodies and any identification numbers it has                     Moreover , the inspection body shall carry out tests on
     assigned them and shall ensure that the list is kept up                test-pieces taken from a representative production
    to date .';                                                             test-piece or from a vessel , as the manufacturer
                                                                            chooses , in order to examine the weld quality . The
                                                                            tests shall be carried out on longitudinal welds .
5.  Article 11 is amended to read as follows :
                                                                            However , where differing weld techniques are used for
                                                                            longitudinal and circular welds , the tests shall be
    'EC verification                                                        repeated on the circular welds .
    Article 1 1                                                            For the vessels referred to in point 2.1.2 of Annex I ,
                                                                           these tests on test-pieces shall be replaced by a
     1.       EC verification is the procedure whereby a                   hydrostatic test on five vessels taken at random from
    manufacturer or his authorized representative                          each batch in order to check that they conform to the
    established within the Community ensures and                           requirements of point 2.1.2 of Annex I.
    declares that the products which have been checked in
    accordance with paragraph 3 are in conformity with                     4.4       In the case of accepted batches , the approved
    the type described in the EC type-examination                          body shall affix , or cause to be affixed , its
    certificate or with the design and manufacturing                       identification number to each product and draw up a
    schedule referred to in point 3 of Annex II .                          written certificate of conformity relating to the tests
                                                                           carried out . All products in the batch may be placed
    2.        The manufacturer shall take all the necessary                on the market except for those products from the
    measures for the manufacturing process to ensure that                  sample which were found not to be in conformity .
    the products conform to the type described in the EC
    type-examination certificate or to the design and                      Where a batch is rejected the approved body shall take
    manufacturing schedule referred to in point 3 of                       appropriate measures to prevent that batch from being
    Annex        II . The     manufacturer    or  his   authorized         placed on the market . In the event of frequent
    representative established within the Community shall                  rejection of batches the approved body may suspend
    affix the CE marking to each product and draw up a                     statistical verification .
    declaration of conformity .
                                                                           The manufacturer may , under the responsibility of the
    3.       The approved body shall carry out the                         approved body , affix the latter's identification number
    appropriate examinations and tests in order to check                   during the manufacturing process .
 ---pagebreak--- No C 28 / 18                                Official Journal of the European Communities                                         2 . 2 . 93
     4.5       The     manufacturer      or    his     authorized                         The various components of the CE marking
     representative must be able to supply on request the                                 must have substantially the same vertical
     approved body's certificates of conformity .';                                       dimension , which may not be less than
                                                                                          5 mm .
6.   Article 15 is amended to read as follows :                                    ( b ) Inscriptions
                                                                                          The vessel or data plate must bear the CE
     'Article 15                                                                          marking provided for in Article 16 , together
                                                                                         with at least the following information :
     Without prejudice to Article 7 , where a Member State                               — the maximum working pressure ( PS in
     establishes that the CE marking has been affixed                                        bar )
     unduly , the manufacturer or his authorized
     representative established within the Community shall                               — the maximum working temperature (Tmax
     be obliged to make the product comply and to end the                                    in °C )
     infringement under the conditions imposed by the
     Member State . Where non-conformity continues , the                                 — the minimum working temperature (Tmin
                                                                                             in °C )
     Member State must take all appropriate measures to
     restrict or prohibit the placing on the market of the                               — the capacity of the vessel (V in L )
    product in question or to ensure that it is withdrawn
     from the market .'                                                                  — the name or mark of the manufacturer
                                                                                         — the type and serial or batch identification
                                                                                             of the vessel
7 . The second subparagraph of Article 16 ( 1 ) is amended
    to read as follows :
                                                                                         — the last two digits of the year in which the
                                                                                             production phase was inspected .'
    'The CE conformity marking shall consist of the
    initials "CE " in the form shown in the model in                                     Where a data plate is used , it must be so
                                                                                         designed that it cannot be re-used and must
    Annex II . The CE marking shall be followed by the
    distinguishing number referred to in Article 9 ( 1 ) of                              include a vacant space to enable other
    the approved inspection body responsible for EC                                      information to be provided .
    verifications or EC surveillance .'
                                                                                                      Article 2
8 . The following is added to Article 16 ( 2 ):
                                                                       Directive 88 / 378 / EEC ( x ) concerning the safety of toys is
    'However , any other mark may be affixed to the                    hereby amended as follows :
    vessels on the data plate provided that the visibility
    and legibility of the CE marking is not thereby                    1 . Throughout the text , "EC mark is replaced by "CE
    reduced . Anyone holding a trade mark registered in a                    marking".
    Member State before 30 June 1989 and actually used
    which is likely to be confused with the CE marking                 2 . Article 5 ( 1 ) is amended to read as follows :
    may continue to use that mark for a period of 10 years
    from the date of adoption of this text .'                                '1 .     Member States shall presume that toys bearing
                                                                             the CE marking laid down in Article 11 comply with
9 . In Annex II point 1 is amended to read as follows :                      all the provisions of this Directive , including the
                                                                             conformity assessment procedures referred to in
                                                                             Articles 8 , 9 and 10 .
    '1 .  CE MARKING AND INSCRIPTIONS
                                                                             Conformity of toys with the national standards which
          ( a ) CE marking                                                   transpose the harmonized standards the reference
                                                                             numbers of which have been published in the Official
                The CE conformity marking shall consist of                  Journal of the European Communities shall result in a
                the initials "CE " in the following form :                  presumption of conformity with the essential safety
                                                                             requirements referred to in Article 3 . Member States
                                                                             shall publish the reference numbers of such national
                                                                             standards .';
                                                                      3 . The following paragraph 3 is added to Article 5 :
                                                                            '3 , ( a ) Where the toys are subject to other directives
                                                                                        covering other aspects which also provide for
                If the marking is reduced or enlarged the                               the affixing of the CE marking , the latter shall
                proportions given in the above graduated
                drawing must be respected .                           i 1 ) OJ No L 187 , 16 . 7 . 1988 , p . 1 .
 ---pagebreak--- 2 . 2 . 93                                    Official Journal of the European Communities                                   No C 28 / 19
                  indicate that the toys in question are                 8.   A new Annex V is inserted :
                  presumed to conform to the provisions of
                  those other directives .                                    'ANNEX V
           ( b ) However , should one or more of these
                  directives allow the manufacturer , during a
                                                                              The CE conformity marking shall consist of the initials
                                                                              "CE " taking the following form :
                  transitional period , to choose which
                  arrangements to apply , the CE marking shall
                  indicate conformity only with the directives
                  applied by the manufacturer .
           ( c ) Particulars of all the said directives , as
                  published in the Official Journal of the
                  European Communities, must be given in the
                  documents , notices or instructions required by             If the marking is reduced or enlarged the proportions
                  the directives and accompanying such toys or ,              given in the above graduated drawing must be
                  failing that , on their packaging .';                       respected .
4 . Article 9 ( 2 ) is amended to read as follows :                           The various components of the CE marking must have
                                                                              substantially the same vertical dimension , which may
      '2 .      Member States shall inform the Commission                     not be less than 5 mm .'.
      and the other Member States of the approved bodies
      responsible for carrying out the EC type-examination
      referred to in Articles 8 ( 2 ) and 10 .                                                         Article 3
      The Commission shall , for information , publish a list
      of these bodies in the Official Journal of the European            Directive 89 / 106 / EEC (') on construction products is
      Communities and shall ensure that the list is kept up              hereby amended as follows :
     to date .';
                                                                         1 . Throughout the text , 'EC mark' is replaced by 'CE
                                                                             marking'.
5 . Article 11 ( 2 ) is amended to read as follows :
     '2 .       The CE conformity marking shall consist of the           2 . Article 2 ( 2 ) is amended to read as follows :
      initials "CE " taking the form of the specimen given in
     Annex V. ';                                                             '2 , ( a ) When products are subject to other
                                                                                        Community directives with regard to other
                                                                                        aspects which also provide for the affixing of
6 . The following is added to Article 11 ( 3 ):                                         the CE marking , the said CE conformity
                                                                                        marking , hereinafter referred to as the " CE
     'However , any other mark may be affixed to the toys ,                             marking", referred to in Article 4 ( 2 ) shall
     their packaging or a label provided that the visibility                            indicate in these cases that the requirements of
     and legibility of the "CE " marking is not thereby                                 those other directives which apply to them
     reduced .                                                                          have also been complied with .
                                                                                  ( b ) However , should one or more of these
     Anyone holding a trade mark registered in a Member
                                                                                        directives allow the manufacturer , during a
     State before 30 June 1989 and actually used which is
                                                                                        transitional period , to choose which
     likely to be confused with the "CE " marking may
                                                                                        arrangements to apply , the CE marking shall
     continue to use that mark for a period of 10 years
                                                                                        indicate conformity only with the directives
     from the date of adoption of this text .';
                                                                                        applied by the manufacturer .
7 . A new paragraph 1 ( a ) is added to Article 12 :                              ( c ) In this case , particulars of the said directives ,
                                                                                        as published in the Official Journal of the
                                                                                        European Communities, must be given in the
     'Without prejudice to Article 7 , where a Member State                             documents , notices or instructions required ,
     establishes that the CE marking has been affixed                                   by the directives and accompanying such
     unduly , the manufacturer or his authorized                                        products .';
     representative established within the Community shall
     be obliged to make the product comply and to end the
     infringement under the conditions imposed by the                   3 . Article 4 ( 2 ) is amended to read as follows :
     Member State . Where non-conformity continues , the
     Member State must take all appropriate measures to                      '2 .      Member States shall presume that products are
     restrict or prohibit the placing on the market of the                   fit for use if they enable works in which they are
    product in question or to ensure that it is withdrawn
     from the market .';                                                H OJ No L 40 , 11 . 2 . 1989 , p . 12 .
 ---pagebreak---  No C 28 / 20                               Official Journal of the European Communities                                          2 . 2 . 93
      employed , provided the latter are properly designed                    An identification number shall be assigned by the
      and built , to satisfy the essential requirements referred              Commission to the bodies involved in the production
      to in Article 3 where such products bear the CE                         control phase . The Commission shall , for information ,
      marking indicating that they satisfy all the provisions                 publish in the Official Journal of the European
      of this Directive , including the conformity procedures                 Communities a list of these bodies and any
      laid down in Chapter III .';                                            identification numbers it has assigned them and shall
                                                                              ensure that the list is kept up to date .';
 4 . Article 4 ( 6 ) is amended as follows :
                                                                        8 . In Annex III point 4.1 is amended to read as
                                                                              follows :
      First subparagraph :
                                                                              '4.1 CE conformity marking
      'The CE marking signifies that products satisfy the
      requirements of paragraphs 2 and 4 of this Article . It                       The CE conformity marking shall consist of the
      is   for    the    manufacturer      or   his   authorized                     CE symbol as given below :
      representative established within the Community to
      take responsibility for affixing the CE marking on the
      product itself, on a label attached to it , on its
      packaging , or on the accompanying commercial
      documents .';
5 . Article 15 ( 2 ) is amended to read as follows :
                                                                                    If the marking is reduced or enlarged the
                                                                                    proportions given in the above graduated
      '2 .   Without prejudice to Article 21 , where a
                                                                                    drawing must be respected .
      Member State establishes that the CE marking has
      been affixed unduly , the manufacturer or his agent                           The various components of the CE marking
      established within the Community shall be obliged to                          must have substantially the same vertical
      make the product comply and to end the infringement                           dimension , which may not be less than 5 mm .
      under conditions imposed by the Member State .
      Where non-conformity continues , the Member State                             The marking shall be followed by the
      must take all appropriate measures to restrict or                             identification number of the body involved in the
      prohibit the placing on the market of the product in                          production       control       stage    and ,    where
      question or to ensure that it is withdrawn from the                           appropriate , indications to identify the
      market .';                                                                    characteristics of the product as a function of the
                                                                                    technical specifications .
6 . Article 15 ( 3 ) is amended to read as follows :                                Additional information
     '3 .    Member States shall take the measures necessary                        It shall be accompanied by the name or
     to prohibit the affixing to products or their packaging                        identifying mark of the producer , the last two
     of marks which are likely to be confused with the CE                           digits of the year of manufacture and the number
     marking. However , any other mark may be affixed to                            of the EC certificate of conformity .'.
     the construction products on a label fixed to the
     product packaging or on the accompanying
                                                                                                      Article 4
     commercial documents provided that the visibility and
     legibility of the "CE " marking is not thereby
     reduced .                                                         Directive         89 / 336 / EEC ( J ),     on     electromagnetic
                                                                      compatibility , as amended by Directive 92 / 31 / EEC ( 2 ), is
                                                                      hereby amended as follows :
     Anyone holding a trade mark registered in a Member
     State before 30 June 1989 and actually used which is              1 . Throughout the text , 'EC mark' is replaced by 'CE
     likely to be confused with the "CE" marking may                         marking'.
     continue to use that mark for a period of 10 years
     from the date of adoption of this text .';                       2.    Article 3 is amended to read as follows :
                                                                            ' Article 3
7 . Article 18 ( 1 ) is amended to read as follows :
                                                                            Member States shall take all appropriate measures to
     '1 .    Each Member State shall forward to the
                                                                            ensure that the apparatus referred to in Article 2 may
     Commission a list of names and addresses of
                                                                            be placed on the market or taken into service only if it
     certification bodies , inspection bodies and testing                   bears the CE marking provided for in Article 10
     laboratories which have been designated by that                        indicating its conformity with all the provisions laid
     Member State for tasks to be carried out for the
                                                                            down        by      this     Directive ,     including      the
     purposes of technical approvals , conformity
     certifications , inspections and tests according to this         H OJ No L 139 , 23 . 5 . 1989 , p . 19 .
     Directive .                                                      ( 2 ) OJ No L 126 , 12 . 5 . 1989 , p . 11 .
 ---pagebreak--- 2 . 2 . 93                                 Official Journal of the European Communities                                   No C 28 / 21
     conformity assessment procedures laid down in                                Where apparatus is the subject of other Directives
     Article     10 , where    it is  installed  and   used   as                  providing for the CE conformity marking , the
      intended .';                                                                affixing of the CE marking shall also indicate
                                                                                  conformity with the provisions of those other
                                                                                  Directives .
3 . The following text is added at the end of Article                             However , should one or more of these directives
      10 ( 1 ):                                                                   allow the manufacturer , during a transitional
                                                                                  period , to choose which arrangements to apply ,
                                                                                  the CE marking shall indicate conformity only
     'Member States shall take the necessary measures to                          with the directives applied by the manufacturer .
     prohibit the affixing to apparatus , its packaging , the
     instructions for use and the guarantee certificate of                        In this case , the particulars of the said directives
     marks which are likely to be confused with the EC                            as published in the Official Journal of the
     mark . However , any other mark may be affixed to the                        European Communities must be given in the
     apparatus , its packaging , the instructions for use or                      documents , notices or instructions required by the
     the guarantee certificate provided that the visibility                       directives and accompanying such apparatus .
     and legibility of the "CE " marking is not thereby
     reduced . Anyone holding a trade mark registered in a                        The various components of the CE marking must
     Member State before 30 June 1989 and actually used                           have substantially the same vertical dimension ,
     which is likely to be confused with the "CE " marking                        which may not be less than 5 mm .'.
     may continue to use that mark for a period of 10 years
     from the date of adoption of this text .';
                                                                                                    Article 5
4 . A new subparagraph 7 is added to Article 10 :
                                                                      Directive 89 / 392 / EEC (*); on machinery , as amended by
                                                                      Directive 91 / 368 / EEC ( 2 ), is hereby amended as follows :
     '7 .     Without prejudice to Article 9 , where a Member
     State or a competent authority establishes that the CE
     marking has been affixed unduly , the manufacturer or            1 . Throughout the text , 'EC mark' is replaced by 'CE
                                                                            marking'.
     his authorized representative established within the
     Community shall be obliged to make the product
     comply and to end the infringement under conditions              2 . The first subparagraph of Article 5 ( 1 ) is amended to
     imposed by the Member State . Where non-compliance                     read as follows :
                                                                                    •f
     continues , the Member State must take all appropriate
     measures to restrict or prohibit the placing on the                    'Member States shall regard machinery accompanied
     market of the product in question or to ensure that it                 by the EC declaration of conformity referred to in
     is withdrawn from the market .';
                                                                           Annex II and bearing the CE marking provided for in
                                                                           Article 10 as conforming to all the provisions of this
                                                                            Directive , including the conformity assessment
                                                                            procedures laid down in chapter II .';
5.   Annex 1 / 2 is amended to read as follows :
                                                                     3 . Article 8 ( 5 ) is amended to read as follows :
     '2 . CE conformity marking                                            '5 , ( a ) Where the machinery is subject to other
                                                                                       Community Directives concerning other
                                                                                       aspects and which also provide for the
           The CE conformity marking shall consist of the                              affixing of the CE marking referred to in
           initials "CE " taking the following form :                                  Article 10 , the latter shall indicate in these
                                                                                       cases that the machinery also fulfils the
                                                                                       provisions of the other Directives .
                                                                                ( b ) However , should one or more of these
                                                                                       directives allow the manufacturer , during a
                                                                                       transitional period , to choose which
                                                                                       arrangements to apply , the CE marking shall
                                                                                       indicate conformity only with the directives
                                                                                       applied by the manufacturer .
           If the CE marking is reduced or enlarged , the
           proportions given in the above graduated drawing          H OJ No L 183 , 29 . 6 . 1989 , p . 9 .
           must be respected .                                       ( 2 ) OJ No L 198 , 22 . 7 . 1991 , p . 16 .
 ---pagebreak--- No C 28 / 22                                Official Journal of the European Communities                                         2 . 2 . 93
            ( c) In this case , the particulars of the said                 If the marking is reduced or enlarged the proportions
                 Directives , as published in the Official                  given in the above drawing must be respected .
                 Journal of the European Communities, must
                 be given in the documents , notices or                     The various components of the CE marking must have
                 instructions required by the directives and                substantially the same vertical dimension , which may
                 accompanying such machinery .';                            not be less than 5 mm .
                                                                            This minimum dimension                may  be  waived        for
4 . Article 10 ( 1 ) is amended to read as follows :
                                                                            small-scale machinery .'.
      '1 .     The CE conformity marking shall consist of the
      initials "CE ". The form of the marking to be used is
      shown in Annex III .'                                                                            Article 6
                                                                      Directive 89 / 686 / EEC 0 ) on personal                 protective
5 . The following is added to Article 10 ( 3 ):
                                                                      equipment is hereby amended as follows :
     'However , any other mark may be affixed to the
     machinery provided that the visibility and legibility of           1 . Throughout the text , 'EC mark' is replaced by 'CE
     the "CE " marking is not thereby reduced .                               marking'.
     Anyone holding a trade mark registered in a Member                 2 . Article 4 ( 1 ) is amended to read as follows :
     State before 30 June 1989 and actually used which is
     likely to be confused with the "EC" marking may                          '1 .      Member States shall not prohibit , restrict or
     continue to use that mark for a period of 10 years                       hinder the placing on the market of PPE or PPE
     from the date of adoption of this text .';                               components which bear the CE marking attesting to
                                                                              their conformity with all the provisions of this
                                                                              Directive , including the conformity assessment
6 . A new paragraph 4 is added to Article 10 :                                procedures laid down in Chapter III .';
     '4 .      Without prejudice to Article 7 , where a Member         3 . A new paragraph 6 is added to Article 5 :
     State establishes that the CE marking has been affixed
     unduly , the manufacturer or his authorized                              '6 , ( a ) Where the PPE is subject to other Directives
     representative established within the Community shall                               concerning other aspects and which also
     be obliged to make the product comply and to end the                                provide for the affixing of the CE marking
    infringement under the conditions imposed by the                                     referred to in Article 13 , the latter shall
    Member State . Where non-conformity continues , the                                  indicate    that   the   PPE also   fulfils    the
    Member State must take all appropriate measures to                                   provisions of the other Directives .
    restrict or prohibit the placing on the market of the
    product in question or to ensure that it is withdrawn                          ( b ) However , should one or more of these
    from the market .';                                                                  directives allow the manufacturer , during a
                                                                                         transitional period , to choose which
7.  Point 1.7.3 of Annex I is amended as follows :
                                                                                         arrangements to apply , the CE marking shall
                                                                                         indicate that the PPE fulfils the provisions
                                                                                         only of those directives applied by the
    — second indent : the CE marking ( see Annex III ),                                  manufacturer .
    — fifth indent : the year of construction .                                    ( c ) In this case , the particulars of these
                                                                                         directives , as published in the Official
8.  Annex III is amended to read as follows :                                            Journal of the European Communities, must
                                                                                         be given in the documents , notices or
    'ANNEX III
                                                                                         instructions required by the directives and
                                                                                         accompanying such PPE .';
    CE MARKING
                                                                       4 . Article 9 ( 1 ) is amended to read as follows :
    The CE conformity marking shall consist of the initials
                                                                             '1 .       Member States shall inform the Commission
    "CE " taking the following form :
                                                                             and the other Member States of the approved bodies
                                                                             responsible for carrying out the certification
                                                                             procedures referred to in Article 8 and of the
                                                                             identification numbers assigned by the Commission
                                                                             to the bodies involved in the production control
                                                                             phase . The Commission shall , for information ,
                                                                             publish        in    the     Official Journal of          the
                                                                      H OJ No L 399 , 30 . 12 . 1989 , p . 18 .
 ---pagebreak--- 2 . 2 . 93                                     Official Journal of the European Communities                                   No C 28 / 23
        European Communities a list of these bodies and any               11 .   Annex IV is amended to read as follows :
        identification numbers it has assigned them and shall
        ensure that the list is kept up to date .';                               'ANNEX IV
                                                                                 CE CONFORMITY MARKING
  5 . The introductory phrase of Article 12 is amended to
        read as follows :                                                        The CE conformity marking shall consist of the
                                                                                 initials "CE " taking the following form :
        'The EC declaration of conformity is the procedure
        whereby the manufacturer or his authorized
        representative established within the Community .';
  6 . Article 13 ( 1 ) is amended to read as follows :
        '1 .     The CE conformity marking shall consist of
        the initials "CE ". In the event of the involvement of a
                                                                                 If the marking is reduced or enlarged the proportions
                                                                                 given in the above graduated drawing must be
        notified body in the production control phase as                         respected .
        indicated in Article 11 , its identification number shall
        be added .
                                                                                 The various components of the CE marking must
                                                                                 have substantially the same vertical dimension , which
        The form of the marking to be used is shown in                           may not be less than 5 mm . This minimum
        Annex IV .';                                                             dimension may be waived for small-scale PPE .
  7 . Article 13 ( 2 ) is amended to read as follows :                           Additional information:
                                                                                 The last two digits of the year of manufacture of the
        '2 .     The CE marking must be affixed to each piece                    PPE .'.
        of manufactured PPE or to its packaging so as to be
        visible , legible and indelible throughout the expected
        life of the PPE .';                                                                           Article 7
  8 . The following is added to Article 13 ( 3 ):                         Directive 90 / 384 / EEC ( l ) on non-automatic weighing
                                                                          instruments is hereby amended as follows :
        'However , any other mark may be affixed to the PPE
        or its packaging provided that the visibility and                 1 . Throughout the text , 'EC mark' is replaced by 'CE
       legibility of the "CE " marking is not thereby reduced .                marking'.
       Anyone holding a trade mark registered in a Member
        State before 30 June 1989 and actually used the                   2 . Article 2 ( 2 ) is amended to read as follows :
        design of which is likely to be confused with the
        "CE " marking may continue to use that mark for a                      '1 .    Member States shall take all steps to ensure that
       period of 10 years from the date of adoption of this                    instruments may not be brought into service for the
       text .';                                                                uses set out in Article 1 ( 2 ) ( a ) unless they meet the
                                                                               requirements of this Directive which apply to them ,
                                                                               including the conformity assessment procedures
 9 . A new paragraph 4 is added to Article 13 :                                referred to in Chapter II , and accordingly bear the CE
                                                                               marking provided for in Article 10 .';
       'Without prejudice to Article 7 , where a Member
       State establishes that the CE marking has been                    3 . Article 8 ( 3 ) is amended to read as follows :
       affixed unduly , the manufacturer or his authorized
       representative established within the Community                         '3 .    Where the instruments are subject to other
       shall be obliged to make the product comply and to                      directives covering other aspects which also provide
       end the infringement under the conditions imposed                       for the affixing of the CE marking , the latter shall
       by the Member State . Where non-conformity                              indicate that the instruments in question are presumed
       continues ,      the  Member        State  must    take   all           to conform to the provisions of those other
       appropriate measures to restrict or prohibit the                        Directives .
       placing on the market of the product in question or
       to ensure that it is withdrawn from the market .';                      However , should one or more of the Directives which
                                                                               apply to the instruments allow the manufacturer,
                                                                               during a transitional period , to choose which
10 . A new point ( h ) is added to point 1.4 of Annex II :                     arrangements to apply , the CE marking shall indicate
                                                                               conformity only with the directives applied by the
       '( h ) Where appropriate , the references of the                        manufacturer .
              directives applied in accordance with Article 5
              ( 6 ), subparagraph ( c ).';                               (') OJ No L 189 , 20 . 7 . 1990 , p . 1 .
 ---pagebreak---  No C 28 / 24                             Official Journal of the European Communities                                 2 . 2 . 93
      In this case , the particulars of these Directives , as               '3 .  EC verification
      published in the Official Journal of the European
       Communities, must be given in the documents , notices                3.1   This module describes the procedure
      or instructions required by the directives and                              whereby the manufacturer or his
      accompanying such instruments .';                                           authorized      representative   established
                                                                                  within the Community ensures and
                                                                                  declares that the instruments which have
 4 . Article 9 ( 1 ) is amended to read as follows :
                                                                                  been checked in accordance with point 3.3
      '1 .     Member States shall inform the Commission                          are in conformity with the type described
                                                                                  in the EC type-examination certificate and
      and the other Member States of the bodies which they
                                                                                  satisfy the requirements of the Directive
      have designated to carry out the tasks pertaining to the
                                                                                  which apply to them .
      procedure referred to in Article 8 and the specific tasks
      for which each body has been designated and of the                   3.2    The manufacturer shall take all necessary
      notification numbers assigned by the Commission to                          measures in order that the manufacturing
      the bodies involved in the production control phase .                       process ensures conformity of the
                                                                                  instruments with the type as described in
      The Commission shall publish in the Official Journal                        the EC type-examination certificate and
      of the European Communities a list of these notified                        with the requirements of the Directive
      bodies together with any identification numbers                             which apply to them . The manufacturer or
      assigned to them and the tasks for which they have                          his authorized representative established
      been designated and shall ensure that the list is kept up                   within the Community shall affix the CE
      to date .';
                                                                                  marking to each instrument .
5 . The following is added to Article 10 ( 3 ):                            3.3    The notified body shall carry out           the
                                                                                  appropriate examinations and tests            in
     'However , any other mark may be affixed to the                              order to check the conformity of            the
     instruments provided that the visibility and legibility of                   product with the requirements of            the
     the "CE " marking is not thereby reduced .                                   directive by examination and testing of
                                                                                  every instrument ,       as specified in
     Anyone holding a trade mark registered in a Member                           point 3.5 .
     State before 30 June 1989 and actually used which is
     likely to be confused with the "CE " marking may                      3.4    For instruments not subject to EC
     continue to use that mark for a period of 10 years                          type-approval , the documents relating to
     from the date of adoption of this text .';                                  the design of the instrument , as set out in
                                                                                 Annex III , must be accessible to the
                                                                                 notified     body   should    the  latter     so
6.   Article 1 1 is amended to read as follows :
                                                                                 request .
     'Article 1 1                                                          3.5    Verification by examination and testing of
                                                                                 every product
     Without prejudice to Article 7 , where a Member State                 3.5.1 All instruments shall be individually
     establishes that the CE marking has been affixed
                                                                                 examined and appropriate tests , as set out
     unduly , the manufacturer or his authorized
                                                                                 in the relevant standard(s ) referred to in
     representative established within the Community shall
                                                                                 Article 5 , or equivalent tests shall be
     be obliged to make the product comply and to end the
                                                                                 carried out in order to verify their
     infringement under the conditions imposed by the
                                                                                 conformity with the type as described in
     Member State . Where non-conformity continues , the
                                                                                 the EC type-examination certificate and
     Member State must take all appropriate measures to
                                                                                 the requirements of the Directive that
     restrict or prohibit the placing on the market of the                       apply to them .
     product in question or to ensure that it is withdrawn
     from the market .';                                                   3.5.2 The notified body shall affix , or cause to
                                                                                 be affixed , its identification number on
7 . The following points of Annex II are amended to read                         each approved instrument and draw up a
     as follows :                                                                written certificate of conformity relating to
                                                                                 the tests carried out .
           2.1 Third paragraph :                                           3.5.3 The     manufacturer    or   his  authorized
                                                                                 representative shall ensure that he is able
           'The CE marking shall be accompanied by the                           to supply the notified body's certificates of
           identification number of the notified body                            conformity on request .
           responsible for the EC surveillance referred to in
           paragraph 2.4 .';                                              4.     EC unit verification
           In Annex II points 3 and 4 are amended to read as              4.1    EC unit verification is the procedure
           follows :                                                             whereby the manufacturer or his
 ---pagebreak---  2 . 2 . 93                                      Official Journal of the European Communities                                    No C 28 / 25
                      authorized      representative        established     9.    Annex VI is amended to read as follows :
                      within the Community ensures and
                      declares that the instrument , generally                    'ANNEX VI
                      designed for a specific application , which
                      has   been    issued      with   the   certificate          The CE conformity marking shall consist of the initials
                      referred to in point 2 , conforms to the                    "CE " taking the following form :
                      requirements of the Directive that apply to
                      it . The manufacturer or his authorized
                      representative shall affix the CE marking
                      to the instrument .
           4.2        The notified body shall examine the
                      instrument and carry out the appropriate
                     tests , as set out in the respective                         If the marking is reduced or enlarged the proportions
                     standard(s ) referred to in Article 5 , or                   given in the above graduated drawing must be
                     equivalent tests , in order to ensure its                    respected .
                     conformity with the relevant requirements
                     of the Directive .                                           The various components of the CE marking must have
                                                                                  substantially the same vertical dimension , which may
                     The notified body shall affix , or cause to                  not be less than 5 mm .
                     be affixed , its identification number to the
                     approved instrument and shall draw up a                     Additional information :
                     certificate of conformity concerning the
                     tests carried out .                                          The last two digits of the year of inspection of the
                                                                                 production phase .'.
          4.3        The aim of the technical documentation
                     relating to the design of the instrument , as
                     referred to in Annex III , is to enable                                               Article 8
                     conformity with the requirements of the
                     Directive to be assessed and the design ,              Directive 90 / 385 / EEC (') on active implantable medical
                     manufacture and operation of the                       devices is hereby amended as follows :
                     instrument to be understood . It must be
                     accessible to the notified body .';                      1 . Throughout the text , 'CE mark' is replaced by 'CE
                                                                                   marking';
          Point 5.3.1 is amended to read as follows :
                                                                             2 . Article 4 ( 1 ) is amended to read as follows :
          ' 5.3.1   Where a manufacturer has opted for                             '1 .      Member States shall not prevent the placing on
                    execution in two stages of one of the                          the market or the putting into service within their
                    procedures mentioned in 5.1 , and where                        territory of devices bearing the CE marking provided
                    these two stages will be carried out by                        for in Article 12 which indicate that they have been
                    different parties , an instrument which has                    the subject of an evaluation of their conformity in
                    undergone the first stage of the procedure                     accordance with the provisions of Article 9 .';
                    concerned shall carry the identification
                    number of the notified body involved in                  3 . A new paragraph 5 is added to Article 4 :
                    that stage .';
                                                                                   '5 , ( a ) Where the devices are subject to other
          Point 5.3.4 is amended to read as follows :                                         Directives concerning other aspects and
                                                                                              which also provide for the affixing of the CE
                                                                                              marking , the latter shall indicate that the
          '5.3.4 The EC marking shall be affixed to the
                                                                                              devices also fulfil the provisions of the other
                    instrument on completion of the second                                    Directives .
                    stage , along with the identification number
                    of the notified body which took part in the                         ( b ) However , should one or more of these
                    second stage .';                                                          directives allow the manufacturer , during a
                                                                                              transitional period , to choose which
                                                                                              arrangements to apply , the CE marking shall
8 . In Annex IV point               1.1   ( a ), first and      second                        indicate that the devices fulfil the provisions
     subparagraphs are amended to read as follows :                                           only of those directives applied by the
                                                                                              manufacturer .
           the CE conformity marking comprising the CE
           symbol as described in Annex VI ,                                            ( c ) In this case , the particulars of these
                                                                                              directives , as published in the Official
           the    identification   number(s )       of   the   notified                       journal of the European          Communities,
           body / bodies that has / have carried out the EC
           surveillance or the EC verification .';                         (>) OJ No L 189 , 20 . 7 . 1990 , p . 17 .
 ---pagebreak--- No C 28 / 26                             Official Journal of the European Communities                                   2 . 2 . 93
               must be given in the documents , notices or           8. Annex 2 is amended to read as follows :
               instructions required by the directives and
               accompanying such devices .';                            Point 2 , second subparagraph :
                                                                        'The manufacturer or his authorized representative
                                                                        established within the Community shall affix the CE
 4 . Article 11 ( 1 ) is amended to read as follows :                   marking in accordance with Article 12 and shall
                                                                        draw up a written declaration of conformity .
                                                                        This declaration shall cover one or more identified
      '1 .    Member States shall inform the Commission
      and the other Member States of the bodies which                   examples of the product and shall be kept by the
      they have designated to carry out the tasks pertaining            manufacturer or his authorized representative
      to the procedures referred to in Article 9 and 13 and             established within the Community .
      the specific tasks for which each body has been                   The CE marking shall be accompanied by the
      designated and of the identification numbers assigned             identification number of the notified body
      by the Commission to the bodies involved in the                   responsible .';
      production control phase .
                                                                     9. Annex 4 is amended to read as follows :
                                                                        'ANNEX 4
     The Commission shall publish in the Official Journal
      of the European Communities the list of these                     EC VERIFICATION
     notified bodies , together with any identification
     numbers and the tasks for which they have been                     1.    EC verification is the procedure whereby the
     notified and shall ensure that the list is kept up to                    manufacturer or his authorized representative
     date .';                                                                 established within the Community ensures and
                                                                              declares that the products subject to the
                                                                              provisions of point 3 are in conformity with the
                                                                              type as described in the EC type-examination
 5 . The second subparagraph of Article 12 ( 2 ) is
     amended to read as follows :
                                                                              certification and satisfy the requirements of the
                                                                              Directive that apply to them .
                                                                        2.    The       manufacturer     or   his    authorized
     'It must be followed by the identification number of                     representative     established      within       the
     the notified body responsible for implementation of                      Community shall take all measures necessary in
     the procedures set out in Annexes II , IV and V. ';                      order that the manufacturing process ensures
                                                                              conformity of the products with the type as
                                                                              described in the EC type-examination
 6 . The following is added to Article 12 ( 3 ):                              certification and with the requirements of the
                                                                              Directive that apply to them . The manufacturer
                                                                              or his authorized representative established
     'However , any other mark may be affixed to the                          within the Community shall affix the EC
     packaging or to the instruction leaflet accompanying                     marking to each product and draw up a
     the device provided that the visibility and legibility of                declaration of conformity .
     the "CE" marking is not thereby reduced .
                                                                        3.    The manufacturer shall , before the start of
                                                                              manufacture , prepare documents defining the
     Anyone holding a trade mark registered in a Member                       manufacturing processes , in particular as
     State before 30 June 1989 and actually used which is                     regards sterilization , together with all the
     likely to be confused with the "CE " marking may                         routine , pre-established provisions to be
     continue to use that mark for a period of 10 years                       implemented to ensure uniformity of
     from the date of adoption of this text .';                               production and conformity of the products
                                                                              with the type as described in the EC
                                                                              type-examination certificate as well as with the
 7.  Article 13 is amended to read as follows :                               relevant requirements of the Directive .
                                                                        4.    The notified body shall carry out the
                                                                              appropriate examinations and tests in order to
     'Without prejudice to Article 7 , where a Member                         check the conformity of the product with the
     State establishes that the CE marking has been                           requirements of the Directive by examination
     affixed unduly , the manufacturer or his authorized                      and testing of products on statistical basis , as
     representative established within the Community                          specified in point 6 . The manufacturer must
     shall be obliged to make the product comply and to                       authorize the notified body to evaluate the
     end the infringement under conditions imposed by                         efficiency of the measures taken pursuant to
     the Member State . Where non-compliance continues ,                      Section 3 , by audit where appropriate .
     the Member State must take all appropriate measures
     to restrict or prohibit the placing on the market of               5.    The manufacturer shall undertake to institute
     the product in question or to ensure that it is                          and keep updated a post-marketing surveillance
     withdrawn from the market .';                                            system . This undertaking shall include the
 ---pagebreak--- 2 . 2 . 93                                    Official Journal of the European Communities                                      No C 28 / 27
            obligation on the part of the manufacturer to                                 The      manufacturer       may ,     under     the
            notify the competent authorities of the                                       responsibility of the notified body , affix the
            following events immediately on learning of                                   latter's identification number during the
            them :                                                                        manufacturing process .
              ( i ) any change in the characteristics of                          6.5     The     manufacturer       or     his   authorized
                    performances and any inaccuracies in the                              representative shall ensure that he is able to
                     instruction leaflet for a device which might                         supply the notified body's certificate of
                    lead to or have led to the death of a                                 conformity on request .'.
                    patient or deterioration in his state of
                    health ;                                              10 .    Annex 5 is amended to read as follows :
            ( ii ) any technical or medical reason resulting                      Point 2 , second subparagraph : 'The manufacturer or
                    in the withdrawal of a device from the                        his authorized representative established within the
                    market by a manufacturer .                                    Community shall affix the CE marking in accordance
                                                                                  with . . . The CE marking shall be accompanied by
                                                                                  the identification number of the notified body
       6.   Statistical verification                                              responsible .';
       6.1  Manufacturers         shall present     the products          11 .    Annex 9 is amended to read as follows :
            manufactured in the form of uniform batches
            and shall take all necessary measures in order                        'ANNEX 9
            that the manufacturing process ensures the
                                                                                 CE CONFORMITY MARKING
            uniformity of each batch produced .
                                                                                 The CE conformity marking shall consist of the
       6.2 A random sample shall be drawn from each                               initials "CE " taking the following form :
           batch . Products in a sample shall be
           individually examined and appropriate tests , as
           set out in the standard(s ) referred to in
           Article 5 , or equivalent tests shall be carried
           out to ensure their conformity with the type as
           described in the EC type-examination
           certificate and thereby determine whether a
           batch is accepted or rejected .
                                                                                 If the marking is reduced or enlarged the proportions
                                                                                 given in the above graduated drawing must be
       6.3 Statistical control of products shall be based on                     respected .
           attributes , entailing a sampling system with the
           following characteristics :                                           The various components of the CE marking must
                                                                                 have substantially the same vertical dimension , which
           — a level of quality corresponding to a                               may not be less than 5 mm .
                   probability of acceptance of 95 % , with a
                   non-conformity percentage of between 0,29                     This minimum dimension may be waived for
                   and 1 % ;                                                     small-scale devices .'.
           — a limit quality corresponding to a
                   probability of acceptance of 5 % , with a                                            Article 9
                   percentage of non-conformity of between 3
                   and 7% .
                                                                        Directive 90 / 396 / EEC ( l ) on appliances burning gaseous
                                                                        fuels is hereby amended as follows :
       6.4 Where batches are accepted , the notified body
           shall       affix , or   cause   to   be   affixed , its
                                                                         1 . Throughout the text , 'EC mark' is replaced by 'CE
           identification number to each product and                           marking';
           draw up a written certificate of conformity
           relating to the tests carried out . All products in
                                                                        2 . Article 4 ( 1 ) is amended to read as follows :
           the batch may be placed on the market except
           for those products from the sample which were                       '1 .     Member States may not prohibit , restrict or
           found not to be in conformity .                                     impede the placing on the market and the putting into
                                                                               service of appliances which comply with all the
           Where a batch is rejected , the notified body                       provisions of this Directive , including the conformity
           shall take appropriate measures to prevent the                      assessment procedures laid down in Chapter 2 , and
           placing on the market of that batch . In the                        which bear the CE marking provided for in
           event of frequent rejection of batches the                          Article 10 .';
           notified body may suspend the statistical
           verification .                                               ( ] ) OJ No L 196 , 26 . 7 . 1990 , p . 15 .
 ---pagebreak--- No C 28 / 28                               Official Journal of the European Communities                                   2 . 2 . 93
3 . Article 8 ( 5 ) is amended to read as follows :                   6. Article 11 is amended to read as follows :
    '5 , ( a ) Where the appliances are also subject to other            'Article 1 1
               Community directives which also provide for
               the affixing of the CE marking:                           Without prejudice to Article 7 , where a Member State
                                                                         establishes that the CE marking has been affixed
               — their conformity with the provisions of this            unduly , the manufacturer or his authorized
                   Directive shall be verified in accordance
                                                                         representative established within the Community shall
                   with the procedures laid down in                      be obliged to make the product comply and to end the
                   paragraphs 1 and 2 ; and it shall be                  infringement under conditions imposed by the Member
                   ensured that they also comply with the                State . Where non-compliance continues , the Member
                   provisions of the other Directives which              State must take all appropriate measures to restrict or
                   apply to them in accordance with the                  prohibit the placing on the market of the product in
                   procedures laid down in those Directives .            question or to ensure that it is withdrawn from the
                                                                         market .';
               The affixing of the CE marking as referred to
               in paragraph 3 shall indicate that the
               provisions of all the Directives which apply to        7. Annex II is amended to read as follows :
               them have been complied with .
                                                                         2.1 the last three subparagraphs of 2 ( 1 ) should
                                                                                read :
         ( b ) However , should one or more of these
               Directives allow the manufacturer , during a                     'The      manufacturer     or     his   authorized
               transitional period , to choose which                            representative established within the Community
               arrangements to apply , the CE marking shall                     shall affix the CE marking on each appliance and
               indicate that the devices fulfil the provisions                  draw up a written declaration of conformity . The
               only of those Directives applied by the                         declaration of conformity may cover one or more
               manufacturer .
                                                                                appliances and must be kept by the
                                                                                manufacturer . The CE marking shall be followed
         ( c) In this case , the particulars of these Directives ,              by the identification number of the notified body
               as published in the Official Journal of the                     responsible for the random checks set out in
               European Communities, must be given in the                       point 2.3 .';
               documents , notices or instructions required by
               the Directives and accompanying such                      3.1 the last three subparagraphs of 3 ( 1 ) should
               devices .';                                                     read :
                                                                               'The       manufacturer     or     his   authorized
4 . Article 9 ( 1 ) is amended to read as follows :                             representative established within the Community
                                                                               shall affix the CE marking to each appliance and
    '1 .      Member States shall inform the Commission                        draw up a written declaration of conformity .
    and the other Member States of the bodies , hereinafter                     This declaration may cover one or more
    called the "notified bodies", responsible for carrying                      appliances and must be kept by the
    out the procedures referred to in Article 8 and of the                     manufacturer . The CE marking shall be followed
    identification numbers assigned by the Commission to                        by the identification number of the notified body
    the bodies involved in the production control phase .                      responsible for EC surveillance .';
                                                                         4.1 the last three subparagraphs of 4 ( 1 ) should
    The Commission shall , for information , publish in the                    read :
    Official Journal of the European Communities a list of
    these bodies and any identification numbers it has                         'The       manufacturer     or     his   authorized
    assigned to them and shall ensure that the list is kept                    representative established within the Community
    up to date .';                                                             shall affix the CE marking to each appliance and
                                                                               draw up a written declaration of conformity .
                                                                               This declaration may cover one or more
5 . The following is added to Article 10 ( 2 ):
                                                                               appliances and must be kept by the
                                                                               manufacturer . The CE marking shall be followed
    'However , any other mark may be affixed to the                            by the identification number of the notified body
    apparatus or to the data plate provided that the                           responsible for EC surveillance .';
    visibility and legibility of the "CE " marking is not
    thereby reduced .                                                          5.        EC VERIFICATION
    Anyone holding a trade mark registered in a Member                          5.1      EC verification is the procedure whereby
    State before 30 June 1989 and actually used which is                                 the   manufacturer    or   his authorized
    likely to be confused with the "CE " marking may                                     representative established within the
    continue to use that mark for a period of 10 years                                   Community ensures and declares that the
    from the date of adoption of this Regulation .';                                     products subject to the provisions
 ---pagebreak--- 2 . 2 . 93                               Official Journal of the European Communities                               No C 28 / 29
                 of point 3 are in conformity with the type                      sample shall be individually examined
                 as described in the EC type-examination                         and appropriate tests , as set out in the
                 certification and satisfy the requirements                      standard(s) referred to in Article 5 , or
                 of the Directive that apply to them .                           equivalent tests shall be carried out to
                                                                                 ensure their conformity with the type as
           5.2   The     manufacturer     or   his   authorized
                                                                                 described in the EC type-examination
                  representative established within the                          certificate and thereby determine whether
                  Community shall take all measures                              a batch is accepted or rejected .
                  necessary in order that the manufacturing
                 process ensures conformity of the                         5.5.3 Statistical control is as follows :
                 products with the type as described in the
                 EC type-examination certification and
                 with the requirements of the Directive                          Appliances are subject to statistical
                 that apply to them . The manufacturer or                        control by attributes . They should be
                 his authorized representative established                       grouped       into    identifiable     batches
                 within the Community shall affix the EC                         consisting of units of a single model
                 marking to each product and draw up a                           manufactured under the same conditions .
                 declaration of conformity .                                     A batch is examined at random intervals .
                                                                                 The appliances constituting a sample are
           5.3   The notified body shall carry out the                           examined individually and appropriate
                 appropriate examinations and tests in                           tests , as laid down in the respective
                 order to check the conformity of the                            standard(s ) referred to in Article 5 , or
                 product with the requirements of the                            equivalent tests are carried out to
                 Directive by examination and testing of                         determine whether the batch is to be
                 every product , as specified in point 5.4 ,                     accepted or rejected . A sampling system
                 or by examination and testing of                                with the following characteristics is
                 products on a statistical basis , as                            applied :
                 specified in point 5.5 , at the choice of the
                 manufacturer .
                                                                                 — a level of quality corresponding to a
                                                                                      probability of acceptance of 95 % ,
           5.4   Verification by examination and testing
                 of every product
                                                                                      with a non-conformity percentage of
                                                                                      between 0,5 and 1,5% ;
           5.4.1 All products shall be individually
                 examined and appropriate tests , as set                         — a limit quality corresponding to a
                 out in the relevant standard(s ) referred to                         probability of acceptance of 5 % ,
                 in Article 5 , or equivalent tests shall be                          with a percentage of non-conformity
                 carried out in order to verify their                                 of between 5 and 1 0 % .
                 conformity with the type as described in
                 the EC type-examination certificate and                   5.5.4 Where batches are accepted , the notified
                 the requirements of the Directive that                          body shall affix , or cause to be affixed ,
                 apply to them .                                                 its identification number to each product
           5.4.2 The notified body shall affix , or cause to                     and draw up a written certificate of
                 be affixed , its identification number on                       conformity relating to the tests carried
                 each approved product and draw up a                             out . All products in the batch may be
                 written certificate of conformity relating                      placed on the market except for those
                 to the tests carried out .                                      products from the sample which were
                                                                                 found not to be in conformity .
           5.4.3 The    manufacturer      or  his    authorized
                 representative shall ensure that he is able                     Where a batch is rejected , the notified
                 to supply the notified body's certificates                      body shall take appropriate measures to
                 of conformity on request .                                      prevent the placing on the market of that
                                                                                 batch . In the event of frequent rejection
           5.5   Statistical verification                                        of batches the notified body may suspend
                                                                                 the statistical verification .
           5.5.1 Manufacturers shall present the products
                 manufactured in the form of uniform
                                                                                 The manufacturer may , under the
                 batches and shall take all necessary
                                                                                 responsibility of the notified body, affix
                 measures in order that the manufacturing                        the latter's identification number during
                 process ensures the uniformity of each
                                                                                 the manufacturing process .
                 batch produced .
           5.5.2 All   products shall be        available for              5.5.5 The     manufacturer    or     his  authorized
                 verification   in   the   form    of  uniform                   representative shall ensure that he is able
                 batches . A random sample shall be                              to supply the notified body's certificates
                 drawn from each batch . Products in a                           of conformity on request .
 ---pagebreak--- No C 28 / 30                             Official Journal of the European Communities                                           2 . 2 . 93
         6.       EC UNIT VERIFICATION                                         — the type of               electrical   supply used ,    if
                                                                                     applicable ,
         6.1      EC unit verification is the procedure
                  whereby the manufacturer or his                              — the appliance category ,
                  authorized representative established
                  within the Community ensures and                             — the last two digits of the year ofjnspection of
                  declares that the product concerned ,                              the production phase .
                  which has been issued with the certificate
                  referred to in point 2 , conforms to the                     Information needed for installation purposes may
                                                                               be added according to the nature of the
                  requirements of the Directive that apply
                 to it . The manufacturer or his authorized                    appliance .
                 representative shall affix the CE marking
                 to the product and draw up a declaration                3 . If the marking is reduced or enlarged the
                 of conformity .                                               proportions given in the above graduated drawing
                                                                               must be respected .
         6.2     The notified body shall examine the
                 product and carry out the appropriate                         The various components of the CE marking must
                 tests , as set out in the respective                          have substantially the same vertical dimension ,
                 standard(s ) referred to in Article 5 , or                    which may not be less than 5 mm .'.
                 equivalent tests , in order to ensure its
                 conformity        with      the      relevant
                 requirements of the Directive .                                                    Article 10
                 The notified body shall affix , or cause to
                 be affixed , its identification number to         Directive          91 / 263 / EEC { l )     on     telecommunications
                 the approved product and shall draw up            terminal equipment , including the mutual recognition of
                 a certificate of conformity concerning the        their conformity is hereby amended as follows :
                 tests carried out .
        6.3      The aim of the technical documentation              1 . Throughout the text , 'CE mark' is replaced by 'CE
                 relating to the design of the instrument ,               marking'.
                 as referred to in Annex IV , is to enable
                 conformity with the requirements of the
                                                                     2 . Article 3 ( 1 ) is amended to read as follows :
                 directive to be assessed and the design ,
                 manufacture and operation of the
                 product to be understood .
                                                                          '1 .       Member States shall take all appropriate
                                                                          measures to ensure that terminal equipment may be
                 The design documentation referred to in                  placed on the market and put into service only if it
                 Annex IV shall be made available to the                  bears the CE marking referred to in Article 11
                 notified body .                                          attesting to its conformity with the requirements laid
        6.4      If deemed necessary by the notified body ,               down in this Directive , including the conformity
                 the examinations and tests may be                        assessment procedures laid down in Chapter II and
                 carried   out   after  installation   of   the           where it is properly installed and maintained and
                 appliance.                                               used for its intended purpose .';
8. Annex III is amended as follows :                                 3 . A new paragraph 4 is added to Article 3 :
   'ANNEX 111
                                                                          '4 , ( a ) Where the terminal equipment is subject to
   CE MARKING AND INSCRIPTIONS                                                         other directives concerning other aspects
                                                                                       which also provide for the affixing of the CE
   1 . The CE marking consists of the initials "CE " as                                marking , the latter shall indicate that the
       shown below , followed by the identification                                    equipment also fulfils the provisions of those
       number of the notified body involved in the                                     other Directives .
       production control phase .';
                                                                                ( b ) However , should one or more of these
                                                                                       directives allow the manufacturer , during a
                                                                                       transitional period , to choose which
                                                                                       arrangements to apply , the CE marking shall
                                                                                       indicate that the terminal equipment fulfils
                                                                                       the provisions only of those directives
                                                                                       applied by the manufacturer .
   2 . The appliance or its data plate must bear the EC                         ( c ) In this case , the particulars of these
       mark together with the following inscriptions :                                 directives , as published in the Official
                                                                                       journal of the European Communities, must
       — the    manufacturer's     name    or   identification
                                                                                       be given in the documents , notices
            symbol ,
       — the trade name of the appliance ,                         0 ) OJ No L 128 , 23 . 5 . 1991 , p . 1 .
 ---pagebreak--- 2 . 2 . 93                                  Official Journal of the European Communities                                         No C 28 / 31
                   or instructions required by the directives and               Anyone holding a trade mark registered in a Member
                   accompanying the terminal equipment .';                      State before 30 June 1989 and actually used which is
                                                                                likely to be confused with the "CE" marking may
                                                                                continue to use that mark for a period of 10 years
  4 . Article 10 ( 1 ) is amended to read as follows :                          from the date of adoption of this text .';
         '1 .    Member States shall inform the Commission
                                                                                Article 11 ( 4 ) is amended as follows :
         and    the other Member States of the bodies
        established within the Community which they have
        designated for carrying out the certification , product                 — In the penultimate line , 'the EC mark is replaced
        checks and associated surveillance tasks pertaining to                      by the initials CE as indicated in Annex VI .';
        the procedures referred to in Article 9 and of the
        identification numbers assigned by the Commission                       Article 12 is amended to read as follows :
        to the bodies involved in the production control
        phase .
                                                                                'Article 12
        Member States shall apply the minimum criteria set
        out in Annex V for the designation of such bodies .                    Without prejudice to Article 8 , where a Member
        Bodies that satisfy the criteria fixed by the relevant                  State establishes that the CE marking has been
        harmonized standards shall be presumed to satisfy                       affixed unduly , the manufacturer or his authorized
        the criteria set out in Annex V. ';                                    representative established within the Community
                                                                               shall be obliged to make the product comply and to
                                                                               end the infringement under the conditions imposed
 5 . Article 10 ( 3 ) is amended to read as follows :                          by the Member State .
        '3 .    The Commission shall publish in the Official                   Where non-conformity continues , the Member State
       Journal of the European Communities the list of                         must take all appropriate measures to restrict or
        notified bodies together with any identification                       prohibit the placing on the market of the product in
       number and the list of test laboratories together with                  question or to ensure that it is withdrawn from the
       the tasks for which they have been designated and                       market .'
       shall ensure this list is kept up to date .';
                                                                          10 . Annexes II ( 1 ), last sentence , III ( 1 ), last sentence and
 6 . Article 11 ( 1 ) is amended to read as follows :                          IV ( 1 ), last sentence, are amended as follows : 'The
                                                                               manufacturer or his authorized representative
                                                                               established within the Community shall affix the
       '1 .     The marking of terminal equipment complying                    markings provided for in Article 11 ( 1 ) to each
       with this Directive shall consist of the CE marking                     product and draw up a written declaration of
       consisting of the symbol "CE", followed by the                          conformity to type .';
       identification number of the notified body involved in
       the production control stage and a symbol indicating
       that the equipment is intended and is suitable to be               11 . Annex VI is amended as follows :
       connected to the public telecommunications network .
       The form of CE marking to be used is shown in                           'ANNEX VI
       Annex VI , together with the other information .';
                                                                               MARKING FOR THE TERMINAL EQUIPMENT
                                                                               REFERRED TO IN ARTICLE 11 ( 1 )
 7 . The following is added to Article 11 ( 2 ):
                                                                               The CE conformity marking shall consist of the
       'However , any other mark may be affixed to the                         initials "CE " taking the following form , followed
       equipment provided that the visibility and legibility                   by the additional information referred to in
       of the "CE " marking is not thereby reduced .                           Article 11 ( 1 ):
                             " CE  initials           Identification number of the           Symbol of suitability for
                                                              notified body                  connection to the public
                                                                                           telecommunication network
 ---pagebreak---  No C 28 / 32                                Official Journal of the European Communities                                      2 . 2 . 93
          ( See   the    Official  Journal   of   the   European                       the latter shall indicate that the boilers in
          Communities for character font )                                             question also conform to the provisions of
                                                                                       those other Directives .
          If the marking is reduced or enlarged the proportions
          given in the above graduated drawing must be                           ( b ) However, should one or more of these
          respected .                                                                  directives allow the manufacturer , during a
                                                                                       transitional period , to choose which
          The various components of the CE marking must                                arrangements to apply , the CE marking shall
          have substantially the same vertical dimension , which                       indicate that the boilers fulfil the provisions
          may not be less than 5 mm .';                                                only of those directives applied by the
                                                                                       manufacturer .
  12 .    Annex VII is amended as follows :
                                                                                ( c ) In this case, the particulars of these directives ,
          'ANNEX VII
                                                                                       as published in the Official Journal of the
                                                                                       European Communities, must be given in the
          MARKING FOR THE EQUIPMENT REFERRED TO IN                                     documents , notices or instructions required by
          ARTICLE 11 ( 4 )
                                                                                       the directives and accompanying the boilers .';
                                                                       4 . A second subparagraph is added at the end of Article
                                                                            7 4 :
                                                                            'However, any other mark may be affixed to the
                                                                            boilers and appliances provided that the visibility and
         If the marking is reduced or enlarged the proportions              legibility of the "CE" marking is not thereby reduced .
         given in the above graduated drawing must be                       Anyone holding a trade mark registered in a Member
         respected .                                                        State before 30 June 1989 and actually used which is
                                                                           likely to be confused with the "CE'1 marking may
         The various components of the CE marking must                     continue to use that mark for a period of 10 years
         have substantially the same vertical dimension , which             from the date of adoption of this text .';
         may not be less than 5 mm .'.
                                                                       5 . A new paragraph 5 is added to Article 7 :
                               Article 1 1
                                                                           '5 .      Where a Member State or a notified body
Directive 92 / 42 / EEC ( 1 ) on efficiency requirements for               establishes that the CE marking has been affixed
new hot-water boilers fired with liquid or gaseous fuels is                unduly , the manufacturer or his agent established
hereby amended as follows :                                                within the Community shall be obliged to make the
                                                                           product comply and to end the infringement under
 1 . Throughout the text , 'CE mark' is replaced by 'CE                    conditions imposed by the Member State , which must
       marking'.                                                           take all appropriate measures to restrict or prohibit the
                                                                           placing on the market of the product in question or to
                                                                           ensure that it is withdrawn from the market .';
2 . Article 4 ( 1 ) is amended to read as follows :
       '1 .      Member States may not prohibit , restrict or
       impede the placing on the market or entry into service          6 . Article 8 ( 1 ) is amended to read as follows :
       within their territories of appliances and boilers which
       bear the CE marking provided for in Article 7 attesting             '1 .      Member States shall inform the Commission
       to their conformity with all the provisions of this
       Directive , including the conformity assessment                     and the other Member States of the bodies they have
       procedures laid down in Articles 7 and 8 , save as                  designated to carry out the tasks relating to the
       otherwise laid down in the Treaty or other Directives               procedures referred to in Article 7 , hereinafter called
                                                                           "notified bodies" and of the identification numbers
       or Community provisions .';
                                                                           assigned by the Commission to the bodies involved in
                                                                           the production control stage .
3 . A new paragraph 5 is added to Article 4:
       '5 , ( a ) Where the boilers are subject to other                   The Commission shall , for information , publish in the
                  Directives concerning other aspects which also           Official Journal of the European Communities a list of
                  provide for the affixing of the CE marking ,             these notified bodies , together with any identification
                                                                           numbers and shall ensure that the list is kept up to
(') OJ No L 167 , 22 . 7 . 1992 , p . 17 .                                 date .';
 ---pagebreak---  2 . 2 . 93                                Official Journal of the European Communities                                      No C 28 / 33
 7.    Annex I is amended as follows :                                3 . The following paragraph 3 is added to Article 8 :
       'ANNEX 1
                                                                            '3 , ( a ) Where electrical equipment is subject to other
       CE CONFORMITY MARKING               AND    ADDITIONAL                           Directives concerning other aspects which also
       SPECIFIC MARKINGS                                                               provide for the affixing of the CE marking,
                                                                                       the latter shall indicate that the equipment in
       1 . CE conformity marking                                                       question also conforms to the provisions of
                                                                                       those other Directives .
           The CE conformity marking shall consist of the
           initials "CE " taking the following form :
                                                                                 ( b ) However , should one or more of these
                                                                                       directives allow the manufacturer , during a
                                                                                       transitional period , to choose which
                                                                                       arrangements to apply , the CE marking shall
                                                                                       indicate that the electrical equipment fulfils
                                                                                       the provisions only of those directives applied
                                                                                       by the manufacturer .
           If the marking is reduced or enlarged the                             ( c ) In this case , the particulars of these Directives ,
           proportions given in the above graduated drawing                            as published in the Official Journal of the
           must be respected .                                                         European Communities, must be given in the
           The various components of the CE marking must                               documents , notices or instructions required by
           have substantially the same vertical dimension ,                            the directives and accompanying the electrical
           which may not be less than 5 mm .'                                          equipment .';
       2 . Additional specific markings
           Add :                                                     4.   Article 10 is amended to read as follows :
           — the last two digits of the year of inspection of
               the production phase .';                                    'Article 10
 8 . In Annex IV , point 1 to modules C , D and E the last
       sentence of each module is amended as follows : 'The                1.        The CE conformity marking referred to in
      manufacturer or his authorized representative                       Annex III shall be affixed by the manufacturer or his
      established within the Community shall affix the CE                 authorized representative established within the
      marking to each appliance and draw up a written                     Community to the electrical equipment or , failing that ,
      declaration of conformity .'.                                       to the packaging , the instruction sheet or the
                                                                          guarantee certificate so as to be visible, easily legible
                                                                          and indelible .
                             Article 12
                                                                          2.         The affixing on electrical equipment of any other
Directive 73 / 23 / EEC (') on electrical equipment designed              mark , sign or indication liable to cause confusion with
for use within certain voltage limits is hereby amended as                the CE marking shall be prohibited . However , any
follows :
                                                                          other mark may be affixed to the electrical equipment ,
                                                                          its packaging, the instruction sheet or the guarantee
 1 . The following recital is added:                                      certificate provided that the visibility and legibility of
                                                                          the "CE " marking is not thereby reduced .
      'Whereas Decision 90 / 683 / EEC (*) establishes the
      modules for the various phases of the conformity
      assessment procedures which are intended to be used                 Anyone holding a trade mark registered in a Member
      in the technical harmonization Directives ,                         State before 30 June 1989 and actually used which is
                                                                          likely to be confused with the "CE " marking may
      H OJ No L 380 , 31 . 12 . 1990 , p . 13 .';                         continue to use that mark for a period of 10 years
                                                                          from the date of adoption of this text .
2 . Article 8 ( 1 ) is amended to read as follows :
      '1 .   Before being placed on the market , the electrical           3.        Without prejudice to Article 9 , where a Member
      equipment referred to in Article 1 must have affixed to             State establishes that the CE marking has been affixed
      it the CE marking provided for in Article 10 attesting              unduly , the manufacturer or his agent established
      to its conformity with all the provisions of this                   within the Community market shall be obliged to
      Directive , including the conformity assessment                     make the product comply and to end the infringement
      procedure described in Annex IV .';                                 under conditions imposed by the Member State .
                                                                          Where non-compliance continues , the Member State
(>) OJ No L 77 , 26 . 3 . 1973 , p . 29 .                                 must take all appropriate measures to restrict or
 ---pagebreak--- No C 28 / 34                              Official Journal of the European Communities                                         2 . 2 . 93
     prohibit the placing on the market of the product in                     each product and draw up a written declaration of
     question or to ensure that it is withdrawn from the                      conformity .
     market .';
                                                                         2.   The manufacturer shall          establish   the technical
5 . Article 11 : The second subparagraph is deleted ;                         documentation described in paragraph 3 and he or
                                                                              his authorized representative established within the
6.   A new Annex III is inserted :                                            Community shall keep it for a period ending at
                                                                              least 10 years after the last product has been
     'ANNEX III
                                                                              manufactured at the disposal of the relevant
     CE CONFORMITY MARKING AND EC DECLARATION                                 national authorities for inspection purposes .
     OF CONFORMITY
                                                                              Where neither the manufacturer nor his authorized
     A. CE conformity marking                                                 representative      is     established      within      the
                                                                              Community , the obligation to keep the technical
         The CE conformity marking shall consist of the
                                                                              documentation available shall be the responsibility
         initials "CE " taking the following form :                           of the person who places the electrical equipment
                                                                              on the Community market .
                                                                         3.   Technical       documentation       shall    enable     the
                                                                              conformity of the electrical equipment with the
                                                                              requirements of the directive to be assessed . It
                                                                              shall , as far as relevant for such assessment , cover
                                                                              the design , manufacture and operation of the
         If the CE marking is reduced or enlarged the                         electrical equipment . It shall include :
         proportions given in the above graduated drawing                    — a general          description     of    the   electrical
         must be respected .
                                                                                  equipment ;
         The various components of the CE marking must                        — a     list  of the    standards    which    have   been
         have substantially the same vertical dimension ,                         applied ;
         which may not be less than 5 mm .
                                                                             — the       results of the     tests  and    examinations
     B.  Declaration of conformity                                                carried out , etc .
         The declaration of conformity must contain the
                                                                         4 . The manufacturer or his authorized representative
         following elements :
                                                                             shall keep a copy of the declaration of conformity
         — name and address of the manufacturer or his                       with the technical documentation .
             authorized representative established within
             the Community ;                                             5 . The manufacturer shall take all measures necessary
                                                                             in order that the manufacturing process shall
         — a description of the electrical equipment ;                       ensure compliance of the manufactured products
         — the references of the specifications with which                   with the technical documentation referred to in
             conformity is declared ;                                        paragraph 2 and with the requirements of the
         — where       appropriate ,    reference     to   the               Directive that apply to them .'.
             harmonized standards ;
         — identification of the signatory who has been                                          Article 13
             empowered to enter into commitments on
             behalf of the manufacturer or his authorized           1.      Member States shall adopt and publish before 1 July
             representative     established     within     the      1994 the provisions necessary in order to comply with this
             Community .'.;                                         Directive . They shall inform the Commission thereof
                                                                    forthwith and send it the next of the provisions
7.  A new Annex IV is inserted :                                    concerned .
    'ANNEX IV
                                                                    They shall apply these provisions from 1 January 1995 .
    INTERNAL PRODUCTION CONTROL
                                                                    When Member States adopt these provisions , the latter
    1 . Internal production control is the procedure                shall contain a reference to this Directive or shall be
        whereby the manufacturer or his authorized                  accompanied by such a reference at the time of their
        representative established within the Community ,           official publication . The procedure for such reference shall
        who carries out the obligations laid down in                be adopted by Member States .
        point 2 , ensures and declares that the electrical
        equipment satisfies the requirements of the                 2.      Member States shall allow the placing on the market
        directive that apply to it . The manufacturer or his        and the bringing into service of products in accordance
        authorized representative established within the            with the marking arrangements laid down in the Directives
        Community shall affix the CE marking to                     amended by this Directive until 1 January 1997 .