title: Directive 2005/1/EC of the European Parliament and of the Council of 9 March 2005 amending Council Directives 73/239/EEC, 85/611/EEC, 91/675/EEC, 92/49/EEC and 93/6/EEC and Directives 94/19/EC, 98/78/EC, 2000/12/EC, 2001/34/EC, 2002/83/EC and 2002/87/EC in order to establish a new organisational structure for financial services committees  (Text with EEA relevance)

text:
               24.3.2005

               EN

               Official Journal of the European Union

               L 79/9

         DIRECTIVE 2005/1/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
   of 9 March 2005
   amending Council Directives 73/239/EEC, 85/611/EEC, 91/675/EEC, 92/49/EEC and 93/6/EEC and Directives 94/19/EC, 98/78/EC, 2000/12/EC, 2001/34/EC, 2002/83/EC and 2002/87/EC in order to establish a new organisational structure for financial services committees
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 47(2) thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Having consulted the Committee of the Regions,
   Having regard to the opinion of the European Central Bank (2),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),
   Whereas:

               (1)

               The Commission Communication of 11 May 1999 entitled ‘Implementing the framework for financial markets: action plan’ identifies a series of actions that are required in order to complete the single market for financial services.

               (2)

               At its meeting in Lisbon of 23 and 24 March 2000, the European Council called for the implementation of this Action Plan by 2005.

               (3)

               On 17 July 2000, the Council set up the Committee of Wise Men on the Regulation of European Securities Markets. In its final report, the Committee of Wise Men called for the establishment of a four-level regulatory framework in order to make the regulatory process for Community securities legislation more flexible, effective and transparent.

               (4)

               In its Resolution on more effective securities market regulation in the European Union, the Stockholm European Council of 23 and 24 March 2001 welcomed the report of the Committee of Wise Men and called for the four-level approach to be implemented.

               (5)

               In the light of those developments, the Commission adopted on 6 June 2001 Decisions 2001/527/EC (4) and 2001/528/EC (5) setting up, respectively, the Committee of European Securities Regulators (CESR) and the European Securities Committee (ESC).

               (6)

               Democratic accountability and transparency must be inherent in the Lamfalussy process and its extension, which can only be sufficiently guaranteed by respecting the interinstitutional balance with regard to implementing measures.

               (7)

               This Directive amends Council Directives 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life assurance (6), 85/611/EEC of 20 December 1985 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (7), 91/675/EEC of 19 December 1991 setting up an insurance committee (8), 92/49/EEC of 18 June 1992 on the coordination of laws, regulations and administrative provisions relating to direct insurance other than life assurance (third non-life insurance Directive) (9) and 93/6/EEC of 15 March 1993 on the capital adequacy of investment firms and credit institutions (10) and Directives of the European Parliament and of the Council 94/19/EC of 30 May 1994 on deposit-guarantee schemes (11), 98/78/EC of 27 October 1998 on the supplementary supervision of insurance undertakings in an insurance group (12), 2000/12/EC of 20 March 2000 relating to the taking up and pursuit of the business of credit institutions (13), 2001/34/EC of 28 May 2001 on the admission of securities to official stock exchange listing and on information to be published on those securities (14), 2002/83/EC of 5 November 2002 concerning life assurance (15) and 2002/87/EC of 16 December 2002 on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate. This Directive aims only at making certain changes in the organisational structure of committees. None of the modifications are intended to extend the powers to adopt implementing measures vested in the Commission pursuant to these Directives, nor the powers vested in the Council pursuant to Directive 93/6/EEC.

               (8)

               In its Resolution of 5 February 2002, the European Parliament endorsed the four-level approach for securities, on the basis of a solemn declaration made before Parliament the same day by the Commission and the letter of 2 October 2001 addressed by the Internal Market Commissioner to the Chairman of the Parliament's Committee on Economic and Monetary Affairs with regard to the safeguards for the European Parliament's role in this process. In its Resolution of 21 November 2002 the Parliament called for certain aspects of that approach to be extended to the banking and insurance sectors subject to a clear commitment on the part of the Council to guarantee a proper institutional balance.

               (9)

               The commitments made by the Commission regarding securities legislation via the abovementioned declaration of 5 February 2002 and letter of 2 October 2001 should be complemented by sufficient guarantees concerning a proper institutional balance.

               (10)

               On 3 December 2002, the Council invited the Commission to implement arrangements for the remaining financial services sectors based upon the Final Report of the Committee of Wise Men.

               (11)

               Safeguards with respect to the extension of the four-level approach are also required because the EU institutions do not yet benefit from an extensive practical experience of the four-level Lamfalussy approach. Furthermore, the first and second Interim Reports of the Interinstitutional Monitoring Group monitoring the Lamfalussy process have made certain remarks and criticisms concerning the functioning of the process.

               (12)

               The speed of adoption of legislation and the quality of legislation are fundamental objectives of the Lamfalussy process. The success of the Lamfalussy process depends more on the political will of the institutional partners to set up an appropriate framework for the adoption of the legislation than on an acceleration of the setting up of the related technical delegated provisions. In addition, an overemphasis on the speed of setting up of the delegated provisions could create significant problems with regard to the quality of those provisions.

               (13)

               The extension of the Lamfalussy procedure is without prejudice to possible decisions regarding the organisation of supervision at a European level.

               (14)

               For those purposes, as regards the banking sector, the role of the Banking Advisory Committee (BAC) set up by Directive 2000/12/EC should be adapted.

               (15)

               To reflect that adapted role, the BAC should be replaced by ‘the European Banking Committee’.

               (16)

               The measures necessary for the implementation of Directive 2000/12/EC are measures of general scope and should be adopted in accordance with Article 5 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (16).

               (17)

               The implementing measures adopted should not modify the essential provisions of the Directives.

               (18)

               The European Parliament should be given a period of three months from the first transmission of draft implementing measures to allow it to examine them and to give its opinion. However, in urgent and duly justified cases this period may be shortened. If, within that period, a resolution is passed by the European Parliament, the Commission will re-examine the draft measures.

               (19)

               In exercising its implementing powers, the Commission should respect the following principles: the need to ensure confidence in financial markets among investors by promoting high standards of transparency in those markets; the need to provide investors with a wide range of competing investments and a level of disclosure and protection tailored to their circumstances; the need to ensure that independent regulatory authorities enforce the rules consistently, especially as regards the fight against economic crime; the need for high levels of transparency and consultation with all market participants and with the European Parliament and the Council; the need to encourage innovation in financial markets if they are to be dynamic and efficient; the need to ensure market integrity by close and reactive monitoring of financial innovation; the importance of reducing the cost of, and increasing access to, capital; the balance of costs and benefits to market participants on a long-term basis (including small and medium-sized businesses and small investors) in any implementing measures; the need to foster the international competitiveness of EU financial markets without prejudice to a much-needed extension of international cooperation; the need to achieve a level playing field for all market participants by establishing EU-wide regulations every time it is appropriate; the need to respect differences in national markets where these do not unduly impinge on the cohesion of the single market; and the need to ensure coherence with other Community legislation in this area, as imbalances in information and a lack of transparency may jeopardise the operation of the markets and above all harm consumers and small investors.

               (20)

               Certain existing provisions for technical amendments to Directive 2000/12/EC need to be brought into line with Decision 1999/468/EC.

               (21)

               In order to ensure institutional and legal consistency with the approach taken in other Community sectors, Commission Decision 2004/10/EC (17) established the European Banking Committee in an advisory capacity to assist the Commission as regards the development of Community banking legislation. References to the advisory functions of the BAC in Directive 2000/12/EC should therefore be deleted.

               (22)

               As regards the monitoring of observation ratios for the solvency and liquidity of credit institutions, the competencies of the BAC are no longer needed in view of the harmonisation of capital adequacy rules and of developments in the techniques used by credit institutions to measure and manage their liquidity risk.

               (23)

               Moreover, the substantial progress made in cooperation and exchange of information between supervisory authorities, in particular through Memoranda of Understanding, has rendered superfluous the regular monitoring by the Commission of certain individual supervisory decisions and their systematic reporting to the BAC.

               (24)

               The establishment of the European Banking Committee should not rule out other forms of cooperation between the different authorities involved in the regulation and supervision of credit institutions, in particular within the Committee of European Banking Supervisors established by Commission Decision 2004/5/EC (18).

               (25)

               The Insurance Committee (IC) set up under Directive 91/675/EEC is to assist the Commission in the exercise of the implementing powers granted by Directives adopted in the field of insurance, and in particular to make the technical adaptations necessary to take account of developments in the insurance sector; such measures being taken in accordance with Decision 1999/468/EC.

               (26)

               Under Directive 91/675/EEC, the IC is also to examine any question relating to the application of Community provisions concerning the insurance sector and, in particular, to advise the Commission on proposals for legislation which the Commission intends to present to the European Parliament and to the Council.

               (27)

               In order to build an internal market where policyholders and beneficiaries are properly protected, insurance and occupational pensions undertakings operating in the internal market under the principles of freedom of establishment and freedom to provide services are subject to specific Community legislation. To ensure the proper functioning of the internal market and maintain financial stability, that legislation should be capable of being rapidly adapted to market changes affecting those sectors, in particular with regard to financial and technical aspects.

               (28)

               The role of the IC should therefore be adapted, and this Committee should accordingly be renamed ‘the European Insurance and Occupational Pensions Committee’. However, in the occupational pensions field, the European Insurance and Occupational Pensions Committee should not address labour and social law aspects such as the organisation of occupational regimes, in particular compulsory membership and the results of collective bargaining agreements.

               (29)

               The measures necessary for the implementation of acts covered by Directive 91/675/EEC are measures of general scope and should be adopted in accordance with Article 5 of Decision 1999/468/EC.

               (30)

               To ensure institutional and legal consistency with the approach taken in other Community sectors, Commission Decision 2004/9/EC (19), established the European Insurance and Occupational Pensions Committee in an advisory capacity to assist the Commission in the fields of insurance and occupational pensions. References to the advisory functions of the IC in Directive 91/675/EEC should therefore be deleted.

               (31)

               Directive 85/611/EEC set up the UCITS Contact Committee to assist the Commission by facilitating the harmonised implementation of that Directive through regular consultations, promoting consultation between Member States and advising the Commission, if necessary, on amendments to be made to that Directive.

               (32)

               The UCITS Contact Committee also acts as a ‘comitology’ Committee within the meaning of Decision 1999/468/EC to assist the Commission with regard to the technical amendments to be made to Directive 85/611/EEC.

               (33)

               On 3 December 2002, the Council invited the Commission to take steps in order to transfer to the ESC, inter alia, the function of advice to the Commission in the exercise of its implementing powers held by the UCITS Contact Committee.

               (34)

               In order to fully implement the model set out in recent Directives in the securities field, in particular Directive 2003/6/EC of the European Parliament and of the Council of 28 January 2003 on insider dealing and market manipulation (market abuse) (20), which gives to the ESC the function to advise the Commission in the exercise of its regulatory powers, while leaving the organisation of other aspects of the ESC's work to be governed by Decision 2001/528/EC, it is necessary to delete the provisions setting up, under Article 53 of Directive 85/611/EEC, the organisation and functions of the present UCITS Contact Committee outside its ‘comitology’ capacity.

               (35)

               The competences of the ESC should therefore be expressly extended beyond those already conferred upon it by Directive 2003/6/EC, to cover the functions currently laid down in Directive 85/611/EEC. The measures necessary for the implementation of the latter Directive are measures of general scope and should be adopted in accordance with Article 5 of Decision 1999/468/EC.

               (36)

               It is accordingly necessary to amend Directives 73/239/EEC, 85/611/EEC, 91/675/EEC, 92/49/EEC, 93/6/EEC, 94/19/EC, 98/78/EC, 2000/12/EC, 2001/34/EC, 2002/83/EC and 2002/87/EC,

         HAVE ADOPTED THIS DIRECTIVE:
   CHAPTER I
   AMENDMENTS TO DIRECTIVES 93/6/EEC, 94/19/EC, AND 2000/12/EC ON THE BANKING SECTOR

      Article 1

      Directive 93/6/EEC

   In the third sentence of Article 7(9) of Directive 93/6/EEC, the words ‘and to the Banking Advisory Committee’ shall be deleted.

      Article 2

      Directive 94/19/EC

   In the third subparagraph of Article 3(1) of Directive 94/19/EC, the words ‘Banking Advisory Committee’ shall be replaced by the words ‘European Banking Committee’.

      Article 3

      Directive 2000/12/EC

   Directive 2000/12/EC is hereby amended as follows:

               1.

               Article 2(4) shall be replaced by the following:

                           ‘4.

                           The Commission, pursuant to the procedure referred to in Article 60(2), shall decide on amendments to the list in paragraph 3.’;

               2.

               in Article 2(5), the third subparagraph shall be replaced by the following:
               ‘In the case of credit institutions other than those which are set up in areas newly reclaimed from the sea or which have resulted from scission or mergers of existing institutions dependent on or answerable to the central body, the Commission, pursuant to the procedure referred to in Article 60(2), may lay down additional rules for the application of the second subparagraph including the repeal of exemptions provided for in the first subparagraph, where it is of the opinion that the affiliation of new institutions benefiting from the arrangements laid down in the second subparagraph might have an adverse effect on competition.’;

               3.

               Article 4 shall be replaced by the following:
               ‘Article 4

                  Authorisation

               Member States shall require credit institutions to obtain authorisation before commencing their activities. They shall lay down the requirements for such authorisation subject to Articles 5 to 9, and notify them to the Commission.’;

               4.

               in Article 22(9), the second sentence shall be deleted;

               5.

               in Article 22(10), the second sentence shall be deleted;

               6.

               Article 23(1) shall be replaced by the following:

                           ‘1.

                           The competent authorities of the Member States shall inform the Commission and the competent authorities of the other Member States:

                                       (a)

                                       of any authorisation of a direct or indirect subsidiary one or more of whose parent undertakings are governed by the laws of a third country;

                                       (b)

                                       whenever such a parent undertaking acquires a holding in a Community credit institution such that the latter would become its subsidiary.
                                       When authorisation is granted to the direct or indirect subsidiary of one or more parent undertakings governed by the law of third countries, the structure of the group shall be specified in the notification which the competent authorities shall address to the Commission in accordance with Article 11.’;

               7.

               in Article 24(2), the words ‘Banking Advisory Committee’ shall be replaced by the words ‘European Banking Committee’;

               8.

               Article 25(3) shall be replaced by the following:

                           ‘3.

                           Without prejudice to Article 300(1) and (2) of the Treaty, the Commission shall, with the assistance of the European Banking Committee, examine the outcome of the negotiations referred to in paragraph 1 and the resulting situation.’;

               9.

               in the third sentence of Article 49(2), the words ‘Banking Advisory Committee’ shall be replaced by the words ‘European Banking Committee’;

               10.

               in Article 52(9), the third sentence shall be replaced by the following:
               ‘The competent authority concerned shall forward such information to the competent authorities of the other Member States.’;

               11.

               in Article 56a, second paragraph, first sentence, the words ‘The Banking Advisory Committee may’ shall be replaced by the words ‘The Commission may request the European Banking Committee to’;

               12.

               Title VI shall be deleted;

               13.

               Article 60(2) shall be replaced by the following:

                           ‘2.

                           The Commission shall be assisted by the European Banking Committee instituted by Commission Decision 2004/10/EC (21) (hereinafter referred to as the Committee).

                  (21)  OJ L 3, 7.1.2004, p. 36.;’"

               Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
               The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
               The Committee shall adopt its rules of procedure.

               14.

               in Article 64(2) and (6), the words ‘and the Banking Advisory Committee’ shall be deleted.

         CHAPTER II
   AMENDMENTS TO DIRECTIVES 73/239/EEC, 91/675/EEC, 92/49/EEC, 98/78/EC AND 2002/83/EC ON THE INSURANCE AND OCCUPATIONAL PENSIONS SECTORS

      Article 4

      Directive 73/239/EEC

   Directive 73/239/EEC is hereby amended as follows:

      ‘Article 29a
      1.   The competent authorities of the Member States shall inform the Commission and the competent authorities of the other Member States:

                  (a)

                  of any authorisation of a direct or indirect subsidiary, one or more of whose parent undertakings are governed by the law of a third country;

                  (b)

                  whenever such a parent undertaking acquires a holding in a Community insurance undertaking which would turn the latter into its subsidiary.

            2.   When the authorisation referred to in paragraph 1(a) is granted to the direct or indirect subsidiary of one or more parent undertakings governed by the law of a third country, the structure of the group shall be specified in the notification which the competent authorities shall address to the Commission.’;

   2)   in Article 29b(4), the second subparagraph shall be replaced by the following:
   ‘In the circumstances described in the first subparagraph, it may also be decided at any time, and in addition to initiating negotiations, in accordance with the procedure referred to in Article 5 of Decision 1999/468/EC (22) and in compliance with Article 7(3) and Article 8 thereof that the competent authorities of the Member States must limit or suspend their decisions regarding the following:
                  (a)

                  requests for authorisation, whether pending at the moment of the decision or submitted thereafter;

                  (b)

                  the acquisition of holdings by direct or indirect parent undertakings governed by the law of the third country in question.

      Article 5

      Directive 91/675/EEC

   Directive 91/675/EEC is hereby amended as follows:
   1.   in the title, the words ‘Insurance Committee’ shall be replaced by the words ‘European Insurance and Occupational Pensions Committee’;
   2.   Article 1 shall be replaced by the following:

      ‘Article 1
      1.   The Commission shall be assisted by the European Insurance and Occupational Pensions Committee established by Commission Decision 2004/9/EC of 5 November 2003 (23) (hereinafter the Committee).
      2.   The chairperson of the Committee of European Insurance and Occupational Pensions Supervisors established by Commission Decision 2004/6/EC (24) shall participate at the meetings of the Committee as an observer.
      3.   The Committee may invite experts and observers to attend its meetings.
      4.   The secretariat of the Committee shall be provided by the Commission.

   3.   Article 2 shall be replaced by the following:

      ‘Article 2
      Where acts adopted in the field of direct non-life insurance and direct life assurance, reinsurance and occupational pensions confer on the Commission powers for the implementation of the rules which they lay down, Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (25) shall apply, having regard to the provisions of Article 8 thereof.
      The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
      2.   The Committee shall adopt its rules of procedure.

   4.   Articles 3 and 4 shall be deleted.

      Article 6

      Directive 92/49/EEC

   In the first sentence of Article 40(10) of Directive 92/49/EEC, the words ‘submit to the Insurance Committee set up by Directive 91/675/EEC a report summarising’ shall be replaced by the words ‘inform the European Insurance and Occupational Pensions Committee of’.

      Article 7

      Directive 98/78/EC

   Directive 98/78/EC is hereby amended as follows:
   1.   Article 10a(3) shall be replaced by the following:

                  ‘3.

                  Without prejudice to Article 300(1) and (2) of the Treaty, the Commission shall, with the assistance of the European Insurance and Occupational Pensions Committee, examine the outcome of the negotiations referred to in paragraph 1 and the resulting situation.’;

   2.   Article 11(5) shall be replaced by the following:

                  ‘5.

                  Not later than 1 January 2006 the Commission shall issue a report on the application of this Directive and, if necessary, on the need for further harmonisation.’.

      Article 8

      Directive 2002/83/EC

   Directive 2002/83/EC is hereby amended as follows:

               1.

               in the first sentence of Article 46(9), the words ‘the Commission shall submit to the Insurance Committee a report summarising’ shall be replaced by the words ‘the Commission shall inform the European Insurance and Occupational Pensions Committee of’;

               2.

               Article 58 shall be replaced by the following:
               ‘Article 58

                  Information from Member States to the Commission

               The competent authorities of the Member States shall inform the Commission and the competent authorities of the other Member States:

                           (a)

                           of any authorisation of a direct or indirect subsidiary, one or more of whose parent undertakings are governed by the laws of a third country;

                           (b)

                           whenever such a parent undertaking acquires a holding in a Community assurance undertaking which would turn the latter into its subsidiary.

                     When the authorisation referred to in point (a) is granted to the direct or indirect subsidiary of one or more parent undertakings governed by the law of third countries, the structure of the group shall be specified in the notification which the competent authorities shall address to the Commission and to the other competent authorities.’;

               3.

               Article 65(1) shall be replaced by the following:

                           ‘1.

                           The Commission shall be assisted by the European Insurance and Occupational Pensions Committee established by Commission Decision 2004/9/EC (26).

                  (26)  OJ L 3, 7.1.2004, p. 34.’"

         CHAPTER III
   AMENDMENTS TO DIRECTIVES 85/611/EEC AND 2001/34/EC ON THE SECURITIES SECTOR

      Article 9

      Directive 85/611/EEC

   Directive 85/611/EEC is hereby amended as follows:

               1.

               Article 6c shall be amended as follows:

                           (a)

                           in paragraph 9, the second sentence shall be replaced by the following:
                           ‘Every two years the Commission shall issue a report on such cases.’;

                           (b)

                           in paragraph 10, the second sentence shall be replaced by the following:
                           ‘Every two years the Commission shall issue a report on such cases.’;

               2.

               in Article 14(6), the second subparagraph shall be deleted;

               3.

               in Article 21(4), the third sentence shall be replaced by the following:
               ‘Such information shall be the subject of exchanges of views within the European Securities Committee.’;

               4.

               in the third subparagraph of Article 22(4), the fourth sentence shall be replaced by the following:
               ‘Such communications may be the subject of exchanges of views within the European Securities Committee.’;

               5.

               the title of Section X shall be replaced by the following:
               ‘European Securities Committee’;

               6.

               Article 53 shall be deleted;

               7.

               Article 53a shall be replaced by the following:
               ‘Article 53a

               The technical amendments to be made to this Directive in the following areas shall be adopted in accordance with the procedure referred to in Article 53b(2):

                           (a)

                           clarification of the definitions in order to ensure uniform application of this Directive throughout the Community;

                           (b)

                           alignment of terminology and the framing of definitions in accordance with subsequent acts on UCITS and related matters.’;

               8.

               the following Article shall be inserted:
               ‘Article 53b

               1.   The Commission shall be assisted by the European Securities Committee instituted by Commission Decision 2001/528/EC (27), hereinafter “the Committee”.
               Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC (28) shall apply, having regard to the provisions of Article 8 thereof.
               The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
               3.   The Committee shall adopt its rules of procedure.

                  (27)  OJ L 191, 13.7.2001, p. 45. Decision as amended by Decision 2004/8/EC (OJ L 3, 7.1.2004, p. 33)."

                  (28)  OJ L 184, 17.7.1999, p. 23.’"

      Article 10

      Directive 2001/34/EC

   Directive 2001/34/EC is hereby amended as follows:

               1.

               Article 108 shall be deleted;

               2.

               Article 109 shall be replaced by the following:
               ‘Article 109
               1.   For the purpose of adjusting, in the light of the requirements of the economic situation, the minimum amount of the foreseeable market capitalisation laid down in Article 43(1), the Commission shall submit to the European Securities Committee instituted by Commission Decision 2001/528/EC of 6 June 2001 (29) a draft of the measures to be taken.
               Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (30) shall apply, having regard to Article 8 thereof.
               The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
               3.   The Committee shall adopt its rules of procedure.

                  (29)  OJ L 191, 13.7.2001, p. 45. Decision as amended by Decision 2004/8/EC (OJ L 3, 7.1.2004, p. 33)."

                  (30)  OJ L 184, 17.7.1999, p. 23.’"

         CHAPTER IV
   AMENDMENT TO DIRECTIVE 2002/87/EC ON FINANCIAL CONGLOMERATES

      Article 11

      Directive 2002/87/EC

   Article 19(2) of Directive 2002/87/EC shall be replaced by the following:

                  ‘2.

                  Without prejudice to Article 300(1) and (2) of the Treaty, the Commission shall, with the assistance of the European Banking Committee, the European Insurance and Occupational Pensions Committee and the Financial Conglomerates Committee, examine the outcome of the negotiations referred to in paragraph 1 and the resulting situation.’

   CHAPTER V
   FINAL PROVISIONS

      Article 12

      Implementing measures

   1.   The implementing measures adopted in accordance with the procedure referred to in Articles 5 and 7 of Decision 1999/468/EC having regard to the provisions of Article 8 thereof must not modify the essential provisions of the Directives.
   2.   The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
   3.   Should the conditions established under the Treaty governing the exercise of implementing powers conferred on the Commission be modified, the Commission shall review this Directive and, if appropriate, propose amendments. Such a review shall in any case be carried out by 31 December 2007 at the latest.

      Article 13

      Transposition

   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 13 May 2005.
   When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

      Article 14

      Entry into force

   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

      Article 15

      Addressees

   This Directive is addressed to the Member States.

      Done at Strasbourg, 9 March 2005.

            For the European Parliament

            The President

         J.P.BORRELL FONTELLES

            For the Council

            The President

         N. SCHMIT

      (1)  OJ C 112, 30.4.2004, p. 21.

      (2)  OJ C 58, 6.3.2004, p. 23.

      (3)  Opinion of the European Parliament of 31 March 2004 (not yet published in the Official Journal) and Council Decision of 11 May 2004.

      (4)  OJ L 191, 13.7.2001, p. 43.

      (5)  OJ L 191, 13.7.2001, p. 45. Decision as amended by Decision 2004/8/EC (OJ L 3, 7.1.2004, p. 33).

      (6)  OJ L 228, 16.8.1973, p. 3. Directive as last amended by the 2003 Act of Accession.

      (7)  OJ L 375, 31.12.1985, p. 3. Directive as last amended by Directive 2004/39/EC of the European Parliament and of the Council (OJ L 145, 30.4.2004, p. 1).

      (8)  OJ L 374, 31.12.1991, p. 32. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

      (9)  OJ L 228, 11.8.1992, p. 1. Directive as last amended by Directive 2002/87/EC of the European Parliament and of the Council (OJ L 35, 11.2.2003, p. 1).

      (10)  OJ L 141, 11.6.1993, p. 1. Directive as last amended by Directive 2004/39/EC.

      (11)  OJ L 135, 31.5.1994, p. 5. Directive as amended by the 2003 Act of Accession.

      (12)  OJ L 330, 5.12.1998, p. 1. Directive as amended by Directive 2002/87/EC.

      (13)  OJ L 126, 26.5.2000, p. 1. Directive as last amended by Commission Directive 2004/69/EC (OJ L 125, 28.4.2004, p. 44).

      (14)  OJ L 184, 6.7.2001, p. 1. Directive as last amended by Directive 2004/109/EC (OJ L 390, 31.12.2004, p. 38).

      (15)  OJ L 345, 19.12.2002, p. 1. Directive as amended by Council Directive 2004/66/EC (OJ L 168, 1.5.2004, p. 35).

      (16)  OJ L 184, 17.7.1999, p. 23.

      (17)  OJ L 3, 7.1.2004, p. 36.

      (18)  OJ L 3, 7.1.2004, p. 28.

      (19)  OJ L 3, 7.1.2004, p. 34.

      (20)  OJ L 96, 12.4.2003 p. 16.


title: Council Directive 2013/51/Euratom of 22 October 2013 laying down requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption

text:
               7.11.2013

               EN

               Official Journal of the European Union

               L 296/12

         COUNCIL DIRECTIVE 2013/51/EURATOM
   of 22 October 2013
   laying down requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Articles 31 and 32 thereof,
   Having regard to the proposal from the European Commission drawn up after obtaining the opinion of a group of persons appointed by the Scientific and Technical Committee from among scientific experts in the Member States, in accordance with Article 31 of the Treaty establishing the European Atomic Energy Community,
   Having regard to the opinion of the European Economic and Social Committee (1),
   After consulting the European Parliament,
   Whereas:

               (1)

               The ingestion of water is one of the pathways of incorporation of radioactive substances into the human body. In accordance with Council Directive 96/29/Euratom (2), the contribution to the exposure of the general public as a whole from practices which involve a risk from ionising radiation must be kept as low as reasonably achievable.

               (2)

               In view of the importance for human health of the quality of water intended for human consumption, it is necessary to lay down, at Community level, quality standards which have an indicator function and to provide for the monitoring of compliance with those standards.

               (3)

               Council Directive 98/83/EC (3) sets out indicator parameters relating to radioactive substances in Annex I, Part C and related monitoring provisions in Annex II thereto. However, those parameters fall within the scope of the basic standards defined in Article 30 of the Euratom Treaty.

               (4)

               The requirements for monitoring levels of radioactive substances in water intended for human consumption should therefore be adopted in specific legislation that ensures the uniformity, coherence and completeness of radiation protection legislation under the Euratom Treaty.

               (5)

               Since the Community is competent to adopt the basic safety standards for the protection of the health of workers and general public against the dangers arising from ionising radiations, the provisions of this Directive supersede those of Directive 98/83/EC as regards the requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption.

               (6)

               As recognised by the Court of Justice in its case-law, the tasks imposed on the Community by Article 2(b) of the Euratom Treaty to establish uniform safety standards to protect the health of workers and of the general public do not preclude, unless explicitly stated in those standards, a Member State from providing for more stringent measures of protection. Since this Directive provides for minimum rules, Member States should be free to adopt or maintain more stringent measures in the field covered by this Directive, without prejudice to the free movement of goods in the internal market as defined by the case-law of the Court of Justice.

               (7)

               Parametric values should not be regarded as limit values. In the event that monitoring of water intended for human consumption indicates non-compliance with a parametric value, the Member State concerned should consider whether that poses a risk to human health which requires action and, where necessary, take remedial action to improve the quality of the water to a level which complies with the requirements for the protection of human health from a radiation protection point of view.

               (8)

               Monitoring of waters intended for human consumption put into bottles or containers intended for sale, other than natural mineral waters, for the purpose of checking whether the levels of radioactive substances comply with the parametric values laid down pursuant to this Directive, should be carried out in accordance with the principles of hazard analysis and critical control points (HACCP) as required by Regulation (EC) No 852/2004 of the European Parliament and of the Council (4) and without prejudice to the principles of official controls laid down in Regulation (EC) No 882/2004 of the European Parliament and of the Council (5).

               (9)

               The general public should be adequately and appropriately informed of the quality of water intended for human consumption.

               (10)

               It is necessary to exclude from the scope of this Directive natural mineral waters and waters which are medicinal products, since special rules for those types of water have been established in Directive 2009/54/EC of the European Parliament and of the Council (6) and Directive 2001/83/EC of the European Parliament and of the Council (7).

               (11)

               Each Member State should establish monitoring programmes to check that water intended for human consumption meets the requirements of this Directive.

               (12)

               The methods used to analyse the quality of water intended for human consumption should be such as to ensure that the results obtained are reliable and comparable.

               (13)

               Taking into consideration the large geographical variability in the natural occurrence of radon, the Commission adopted Recommendation 2001/928/Euratom (8), which deals with the quality of water intended for human consumption regarding radon and long-lived radon decay products. It is appropriate to include these radionuclides in the scope of this Directive.

               (14)

               In order to maintain the high quality of water intended for human consumption in view of its importance for human health, it is necessary for Annexes II and III to be regularly updated in the light of scientific and technical progress.

               (15)

               While it is for Member States to define the sampling and analysis frequencies for water intended for human consumption put into bottles or containers intended for sale, it is advisable for those Member States required to monitor water intended for human consumption for radon or tritium or to establish the Indicative Dose (ID), to carry out sampling and analysis at least once per year,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Subject matter
   This Directive lays down requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption. It lays down parametric values and frequencies and methods for monitoring radioactive substances.
   Article 2
   Definitions
   For the purposes of this Directive the following definitions apply:

               (1)

               ‘water intended for human consumption’ means:

                           (a)

                           all water, either in its original state or after treatment, intended for drinking, cooking, food preparation or other domestic purposes, regardless of its origin and whether it is supplied from a distribution network, a tanker, or in bottles or containers;

                           (b)

                           all water used in any food-production undertaking for the manufacture, processing, preservation or marketing of products or substances intended for human consumption unless the competent national authorities are satisfied that the quality of the water cannot affect the wholesomeness of the foodstuff in its finished form;

               (2)

               ‘radioactive substance’ means any substance that contains one or more radionuclides the activity or concentration of which cannot be disregarded as far as radiation protection is concerned;

               (3)

               ‘indicative dose’ or ‘ID’ means the committed effective dose for one year of ingestion resulting from all the radionuclides whose presence has been detected in a supply of water intended for human consumption, of natural and artificial origin, but excluding tritium, potassium-40, radon and short-lived radon decay products;

               (4)

               ‘parametric value’ means the value of radioactive substances in water intended for human consumption above which Member States shall assess whether the presence of radioactive substances in water intended for human consumption poses a risk to human health which requires action and, where necessary, shall take remedial action to improve the quality of water to a level which complies with the requirements for the protection of human health from a radiation protection point of view.

         Article 3
   Scope and exemptions
   1.   This Directive applies to water intended for human consumption.
   2.   This Directive does not apply to:

               (a)

               natural mineral waters recognised as such by the competent national authorities, in accordance with Directive 2009/54/EC;

               (b)

               waters which are medicinal products within the meaning of Directive 2001/83/EC.

         3.   Member States may exempt from this Directive:

               (a)

               water intended exclusively for those purposes for which the competent authorities are satisfied that the quality of the water has no influence, either directly or indirectly, on the health of the general public concerned;

               (b)

               water intended for human consumption from an individual supply providing on average less than 10 m3 a day, or serving fewer than 50 persons, unless the water is supplied as part of a commercial or public activity.

         4.   Member States that have recourse to the exemptions provided for in paragraph 3(b) shall ensure that:

               (a)

               the general public concerned is informed thereof and of any action that can be taken to protect human health from the adverse effects resulting from any contamination of water intended for human consumption;

               (b)

               when a potential danger to human health arising from the quality of such water is apparent, the general public concerned promptly be given appropriate advice.

         Article 4
   General obligations
   Without prejudice to the provisions laid down in point a of Article 6(3) of Directive 96/29/Euratom (9), Member States shall take all measures necessary to establish an appropriate monitoring programme for water intended for human consumption, to ensure that in the event of non-compliance with the parametric values laid down pursuant to this Directive:

               (a)

               it shall be assessed whether that poses a risk to human health which requires action and,

               (b)

               remedial action shall be taken, where necessary, to improve the quality of water to a level which complies with requirements for the protection of human health from a radiation protection point of view.

         Article 5
   Parametric values and points of compliance
   1.   Member States shall set parametric values applicable for the monitoring of radioactive substances in water intended for human consumption in accordance with Annex I.
   2.   Where monitoring of water intended for human consumption is undertaken in accordance with the requirements of Annex II of this Directive the point of compliance shall be:

               (a)

               in the case of water supplied from a distribution network, the point at which it emerges from the taps where the water is normally taken;

               (b)

               in the case of water supplied from a tanker, the point at which it emerges from the tanker;

               (c)

               in the case of water put into bottles or containers intended for sale, the point at which the water is put into the bottles or containers;

               (d)

               in the case of water used in a food-production undertaking, the point where the water is used in the undertaking.

         3.   The definition of points of compliance in paragraph (2)(a) is without prejudice to the choice of a sampling point, which may be any point within the supply zone or at the treatment works provided there is no adverse change in the concentration value between the sampling point and the point of compliance.
   Article 6
   Monitoring and analysis
   1.   Member States shall take all measures necessary to ensure that monitoring for radioactive substances in water intended for human consumption is undertaken in accordance with the monitoring strategies and frequencies set out in Annex II, in order to check whether the values of radioactive substances comply with the parametric values laid down pursuant to Article 5(1).
   Member States shall ensure that monitoring is undertaken so as to ensure that the measured values obtained are representative of the quality of the water consumed throughout the year. For water intended for human consumption that is put into bottles or containers intended for sale, this shall be without prejudice to the principles of HACCP as required by Regulation (EC) No 852/2004 and to the principles of official controls as laid down in Regulation (EC) No 882/2004.
   2.   Monitoring for the ID shall be carried out, and analytical performance characteristics shall be in accordance with the requirements set out in Annex III.
   3.   Member States shall ensure that any laboratory at which samples are analysed has a system of analytical quality control that is subject to checking by an external organisation approved by the competent authority for that purpose.
   Article 7
   Remedial action and notification of the general public
   1.   Member States shall ensure that any failure to comply with a parametric value laid down pursuant to Article 5(1) is immediately investigated in order to identify the cause.
   2.   Where a failure to comply with a parametric value occurs, the Member State shall assess whether the failure poses a risk to human health which requires action.
   3.   In the event that such a risk referred to under paragraph 2 exists, the Member State shall:

               (a)

               take remedial action in order to comply with requirements for the protection of human health from a radiation protection point of view; and

               (b)

               ensure that the general public concerned is:

                           (i)

                           notified of the risk and the remedial action taken; and

                           (ii)

                           advised on any additional precautionary measures that may be needed for the protection of human health in respect of radioactive substances.

         Article 8
   Transposition into national law
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 28 November 2015 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   The Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 9
   Entry into force
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 10
   Addressees
   This Directive is addressed to the Member States.

      Done at Luxembourg, 22 October 2013.

            For the Council

            The President

         L. LINKEVIČIUS

      (1)  OJ C 24, 28.1.2012, p. 122.

      (2)  Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation (OJ L 159, 29.6.1996, p. 1).

      (3)  Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, p. 32).

      (4)  Regulation (EC) No 852/2004 2004 of the European Parliament and of the Council of the 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).

      (5)  Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules, (OJ L 165, 30.4.2004, p. 1.).

      (6)  Directive 2009/54/EC of the European Parliament and of the Council of 18 June 2009 on the exploitation and marketing of natural mineral waters (OJ L 164, 26.6.2009, p. 45).

      (7)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

      (8)  Commission Recommendation 2001/928/Euratom of 20 December 2001 on the protection of the public against exposure to radon in drinking water supplies (OJ L 344, 28.12.2001, p. 85).

      (9)  Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation (OJ L 159, 29.6.1996, p. 1).

      ANNEX I

         PARAMETRIC VALUES FOR RADON, TRITIUM AND ID OF WATER INTENDED FOR HUMAN CONSUMPTION

                  Parameter

                  Parametric value

                  Unit

                  Notes

                  Radon

                  100

                  Bq/l

                  (Note 1)

                  Tritium

                  100

                  Bq/l

                  (Note 2)

                  ID

                  0,10

                  mSv

                              (a)

                              Member States may set a level for radon which is judged inappropriate to be exceeded and below which optimisation of protection should be continued, without compromising water supply on a national or regional scale. The level set by a Member State may be higher than 100 Bq/l but lower than 1 000 Bq/l. In order to simplify national legislation, Member States may choose to adjust the parametric value to this level.

                              (b)

                              Remedial action is deemed to be justified on radiological protection grounds, without further consideration, where radon concentrations exceed 1 000 Bq/l.

                              Note 2:

                              Elevated levels of tritium may indicate the presence of other artificial radionuclides. If the tritium concentration exceeds its parametric value, an analysis of the presence of other artificial radionuclides shall be required.

      ANNEX II

         MONITORING OF RADIOACTIVE SUBSTANCES

      1.   General principles and monitoring frequencies

      All parameters for which parametric values must be set pursuant with Article 5(1) shall be subject to monitoring. However, no monitoring of a specific parameter shall be required where a competent authority can establish that, for a period of time to be determined by them, that parameter is not likely to be present in a given supply of water intended for human consumption in concentrations which could exceed the corresponding parametric value.
      In case of naturally occurring radionuclides, where previous results have shown that the concentration of radionuclides is stable, the frequency, in derogation from the minimum sampling requirements set out in point 6, is to be decided by the Member State, taking into consideration the risk to human health. A Member State is not required to monitor water intended for human consumption for radon or tritium or to establish the ID where it is satisfied on the basis of representative surveys, monitoring data or other reliable information that, for a period of time to be determined by them, the levels of radon, tritium or of the calculated ID will remain below the respective parametric values listed in Annex I. In that case, it shall communicate the grounds for its decision to the Commission and provide the Commission with the necessary documentation supporting that decision, including the findings of any surveys, monitoring or investigations carried out. In this context, the provisions with regard to the minimum sampling and analysis requirements set out in point 6 of this Annex do not apply.
      2.   Radon

      Member States shall ensure that representative surveys are undertaken to determine the scale and nature of likely exposures to radon in water intended for human consumption originating from different types of ground water sources and wells in different geological areas. The surveys shall be designed in such a way that underlying parameters, and especially the geology and hydrology of the area, radioactivity of rock or soil, and well type, can be identified and used to direct further action to areas of likely high exposure. Monitoring of radon concentrations shall be undertaken where there is reason to believe, on the basis of the results of the representative surveys or other reliable information, that the parametric value laid down pursuant to Article 5(1) might be exceeded.
      3.   Tritium

      Member States shall ensure that monitoring of tritium in water intended for human consumption is carried out where an anthropogenic source of tritium or other artificial radionuclides is present within the catchment area and it cannot be shown on the basis of other surveillance programmes or investigations that the level of tritium is below the parametric value listed in Annex I. Where monitoring for tritium is required, it shall be carried out at the frequencies indicated in the table appearing in point 6 of this Annex. If the concentration of tritium exceeds its parametric value, an investigation of the presence of other artificial radionuclides shall be required.
      4.   Indicative dose

      Monitoring of water intended for human consumption for the ID shall be carried out where a source of artificial or elevated natural radioactivity is present and it cannot be shown on the basis of other representative monitoring programmes or other investigations that the level of ID is below the parametric value listed in Annex I. Where monitoring for artificial radionuclide levels is required, it shall be carried out at the frequency indicated in the table appearing in point 6 of this Annex. Where monitoring for natural radionuclide levels is required, each Member State shall define the frequency of the monitoring of either gross alpha activity, gross beta activity or individual natural radionuclides depending on the screening strategy adopted by it (according to Annex III). The monitoring frequency may vary from a single check measurement to the frequencies indicated in the table appearing in point 6 of this Annex. Where only a single check for natural radioactivity is required, a recheck shall be required at least where any change occurs in relation to the supply likely to influence the concentrations of radionuclides in water intended for human consumption.
      5.   Water treatment

      Where treatment to reduce the level of radionuclides in water intended for human consumption has been taken, monitoring shall be carried out at the frequencies indicated in the table appearing in point 6 to ensure the continued efficacy of that treatment.
      6.   Minimum sampling and analysis frequencies

      The minimum sampling and analysis frequency for the monitoring of water intended for human consumption supplied from a distribution network or from a tanker or used in a food production undertaking shall be as set out in the following table:

         Table

         Minimum sampling and analysis frequencies for monitoring of water intended for human consumption supplied from a distribution network or from a tanker or used in a food production undertaking

                  Volume of water distributed or produced each day within a supply zone
                  (Notes 1 and 2)
                  m3

                  Number of samples per year
                  (Notes 3 and 4)

                  volume ≤ 100

                  (Note 5)

                  100 < volume ≤ 1 000

                  1

                  1 000 < volume ≤ 10 000

                  1
                  + 1 for each 3 300 m3/d and part thereof of the total volume

                  10 000 < volume ≤ 100 000

                  3
                  + 1 for each 10 000 m3/d and part thereof of the total volume

                  volume > 100 000

                  10
                  + 1 for each 25 000 m3/d and part thereof of the total volume

                              Note 1:

                              A supply zone is a geographically defined area within which water intended for human consumption comes from one or more sources and within which water quality may be considered as being approximately uniform.

                              Note 2:

                              The volumes are calculated as averages taken over a calendar year. A Member State may use the number of inhabitants in a supply zone instead of the volume of water to determine the minimum frequency, assuming a water consumption of 200 l/day/capita.

                              Note 3:

                              As far as possible, the number of samples should be distributed equally in time and location.

                              Note 4:

                              In the event of intermittent short-term supply the monitoring frequency of water distributed by tankers is to be decided by the Member State concerned.

                              Note 5:

                              The frequency is to be decided by the Member State concerned.

                        Member States shall define sampling frequencies for water intended for human consumption put into bottles or containers intended for sale. In so doing Member States may take into consideration the volume of water produced.

            7.   Averaging

      Where a parametric value is exceeded in a particular sample, Member States shall define the extent of resampling necessary to ensure that the measured values are representative of an average activity concentration for a full year.

      ANNEX III

         MONITORING FOR INDICATIVE DOSE AND ANALYTICAL PERFORMANCE CHARACTERISTICS

      1.   Monitoring for compliance with the ID

      Member States may use various reliable screening strategies to indicate the presence of radioactivity in water intended for human consumption. These strategies may include screening for certain radionuclides, or screening for an individual radionuclide, or gross alpha activity or gross beta activity screening.
      (a)   screening for certain radionuclides, or screening for an individual radionuclide
      If one of the activity concentrations exceeds 20 % of the corresponding derived value or the tritium concentration exceeds its parametric value listed in Annex I, an analysis of additional radionuclides shall be required. The radionuclides to be measured shall be defined by Member States taking into account all relevant information about likely sources of radioactivity.
      (b)   screening strategies for gross alpha activity and gross beta activity
      Member States may use screening strategies for gross alpha activity and gross beta activity (1) to monitor for the parametric indicator value for ID.
      For this purpose gross alpha activity or gross beta activity screening levels shall be set. The recommended screening level for gross alpha activity is 0,1 Bq/l. The recommended screening level for gross beta activity is 1,0 Bq/l.
      If the gross alpha activity and gross beta activity are less than 0,1 Bq/l and 1,0 Bq/l respectively, the Member State may assume that the ID is less than the parametric value of 0,1 mSv and radiological investigation is not needed unless it is known from other sources of information that specific radionuclides are present in the water that are liable to cause an ID in excess of 0,1 mSv.
      If the gross alpha activity exceeds 0,1 Bq/l or the gross beta activity exceeds 1,0 Bq/l, analysis for specific radionuclides shall be required.
      Member States may set alternative screening levels for gross alpha activity and gross beta activity where they can demonstrate that the alternative levels are in compliance with an ID of 0,1 mSv.
      The radionuclides to be measured shall be defined by Member States taking into account all relevant information about likely sources of radioactivity. Since elevated levels of tritium may indicate the presence of other artificial radionuclides, tritium, gross alpha activity and gross beta activity should be measured in the same sample.
      2.   Calculation of the ID

      The ID shall be calculated from the measured radionuclide concentrations and the dose coefficients laid down in Annex III, Table A of Directive 96/29/Euratom or more recent information recognised by the competent authorities in the Member State, on the basis of the annual intake of water (730 l for adults). Where the following formula is satisfied, Member States may assume that the ID is less than the parametric value of 0,1 mSv and no further investigation shall be required:

      where

                  Ci(obs)

                  =

                  observed concentration of radionuclide i

                  Ci(der)

                  =

                  derived concentration of radionuclide i

                  n

                  =

                  number of radionuclides detected.

         Derived concentrations for radioactivity in water intended for human consumption
          (2)

                  Origin

                  Nuclide

                  Derived concentration

                  Natural

                  U-238 (3)

                  3,0 Bq/l

                  U-234 (3)

                  2,8 Bq/l

                  Ra-226

                  0,5 Bq/l

                  Ra-228

                  0,2 Bq/l

                  Pb-210

                  0,2 Bq/l

                  Po-210

                  0,1 Bq/l

                  Artificial

                  C-14

                  240 Bq/l

                  Sr-90

                  4,9 Bq/l

                  Pu-239/Pu-240

                  0,6 Bq/l

                  Am-241

                  0,7 Bq/l

                  Co-60

                  40 Bq/l

                  Cs-134

                  7,2 Bq/l

                  Cs-137

                  11 Bq/l

                  I-131

                  6,2 Bq/l

            3.   Performance characteristics and methods of analysis

      For the following parameters and radionuclides, the method of analysis used must, as a minimum, be capable of measuring activity concentrations with a limit of detection specified below:

                  Parameters and radionuclides

                  Limit of detection (Notes 1, 2)

                  Notes

                  Tritium

                  10 Bq/l

                  Note 3

                  Radon

                  10 Bq/l

                  Note 3

                  gross alpha activity

                  0,04 Bq/l

                  Note 4

                  gross beta activity

                  0,4 Bq/l

                  Note 4

                  U-238

                  0,02 Bq/l

                  U-234

                  0,02 Bq/l

                  Ra-226

                  0,04 Bq/l

                  Ra-228

                  0,02 Bq/l

                  Note 5

                  Pb-210

                  0,02 Bq/l

                  Po-210

                  0,01 Bq/l

                  C-14

                  20 Bq/l

                  Sr-90

                  0,4 Bq/l

                  Pu-239/Pu-240

                  0,04 Bq/l

                  Am-241

                  0,06 Bq/l

                  Co-60

                  0,5 Bq/l

                  Cs-134

                  0,5 Bq/l

                  Cs-137

                  0,5 Bq/l

                  I-131

                  0,5 Bq/l

                              Note 1:

                              The limit of detection shall be calculated according to the ISO standard 11929: Determination of the characteristic limits (decision threshold, detection limit and limits of the confidence interval) for measurements of ionising radiation — Fundamentals and application, with probabilities of errors of 1st and 2nd kind of 0,05 each.

                              Note 2:

                              Measurement uncertainties shall be calculated and reported as complete standard uncertainties, or as expanded standard uncertainties with an expansion factor of 1,96, according to the ISO Guide for the Expression of Uncertainty in Measurement.

                              Note 3:

                              The limit of detection for tritium and for radon is 10 % of its parametric value of 100 Bq/l.

                              Note 4:

                              The limit of detection for gross alpha activity and gross beta activities are 40 % of the screening values of 0,1 and 1,0 Bq/l respectively.

                              Note 5:

                              This limit of detection applies only to initial screening for ID for a new water source; if initial checking indicates that it is not plausible that Ra-228 exceeds 20 % of the derived concentration, the limit of detection may be increased to 0,08 Bq/l for routine Ra-228 nuclide specific measurements, until a subsequent re-check is required.

         (1)  Where appropriate gross beta activity may be replaced by residual beta activity after subtraction of the K-40 activity concentration.

         (2)  This table includes values for the most common natural and artificial radionuclides; these are precise values, calculated for a dose of 0,1 mSv, an annual intake of 730 litre and using the dose coefficients laid down in Annex III, Table A of Directive 96/29/Euratom; derived concentrations for other radionuclides can be calculated on the same basis, and values can be updated on the basis of more recent information recognised by the competent authorities in the Member State.

         (3)  This table allows only for the radiological properties of uranium, not for its chemical toxicity.


Avis juridique important

|

31983L0189

Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations

Official Journal L 109 , 26/04/1983 P. 0008 - 0012 Spanish special edition: Chapter 13 Volume 14 P. 0034  Portuguese special edition Chapter 13 Volume 14 P. 0034  Finnish special edition: Chapter 13 Volume 12 P. 0154  Swedish special edition: Chapter 13 Volume 12 P. 0154

COUNCIL DIRECTIVE of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (83/189/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 100 and 213 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas the prohibition of quantitative restrictions on the movement of goods and of measures having an equivalent effect is one of the basic principles of the Community;  Whereas barriers to trade resulting from technical regulations relating to products may be allowed only where they are necessary in order to meet essential requirements and have an objective in the public interest of which they constitute the main guarantee;  Whereas it is essential for the Commission to have the necessary information at its disposal before the adoption of technical provisions ; whereas, consequently, the Member States which are required to facilitate the achievement of its task pursuant to Article 5 of the Treaty must notify it of their projects in the field of technical regulations;  Whereas all the Member States must also be informed of the technical regulations contemplated by any one Member State;  Whereas the Commission and the Member States must also be allowed sufficient time in which to propose amendments to a contemplated measure, in order to remove or reduce any barriers which it might create to the free movement of goods;  Whereas the Commission must also have the option of proposing or adopting a Community directive governing the subject of the national measure contemplated;  Whereas, in the two instances set out above, the Member State in question must, pursuant to the general obligations laid down in Article 5 of the Treaty, defer implementation of the contemplated measure for a period sufficient to allow either a joint examination of the proposed amendments or the preparation of the proposal for a Council Directive or of the Commission Directive ; whereas the time limits laid down in the Agreement of the representatives of the Governments of the Member States meeting within the Council of 28 May 1969 providing for standstill and notification to the Commission (4), as amended by the Agreement of 5 March 1973 (5), have proved inadequate in the cases concerned and should accordingly be extended;  Whereas the procedure concerning the standstill arrangement and notification of the Commission contained in the abovementioned Agreement of 28 May 1969 remains applicable to products subject to that procedure which are not covered by this Directive;  Whereas, in practice, national technical standards may have the same effects on the free movement of goods as technical regulations;  Whereas it would therefore appear necessary to inform the Commission of draft standards under similar conditions to those which apply to technical regulations ; whereas, pursuant to Article 213 of the Treaty, the Commission may, within the limits and under the conditions laid down by the Council in accordance with the provisions of the Treaty, collect any information and carry out any checks required for the performance of the tasks entrusted to it;  Whereas it is also necessary for the Member States and the standards institutions to be informed of standards contemplated by standards institutions in the other Member States;  (1) OJ No C 253, 1.10.1980, p. 2. (2) OJ No C 144, 15.6.1981, p. 122. (3) OJ No C 159, 29.6.1981, p. 23. (4) OJ No C 76, 17.6.1969, p. 9. (5) OJ No C 9, 15.3.1973, p. 3.   Whereas it is necessary to set up a Standing Committee, the members of which will be appointed by the Member States with the task of helping the Commission to examine draft national standards and cooperating in its efforts to lessen any adverse effects thereof on the free movement of goods,  HAS ADOPTED THIS DIRECTIVE:    Article 1 For the purposes of this Directive, the following meanings shall apply:    1. "technical specification", a specification contained in a document which lays down the characteristics required of a product such as levels of quality, performance, safety or dimensions, including the requirements applicable to the product as regards terminology, symbols, testing and test methods, packaging, marking or labelling;       2. "standard", a technical specification approved by a recognized standardizing body for repeated or continuous application, with which compliance is not compulsory;       3. "standards programme", document listing the subjects for which it is intended to draw up or alter a standard;       4. "draft standard", document containing the text of the technical specifications concerning a given subject, which is being considered for adoption in accordance with the national standards procedure, as that document stands after the preparatory work and as circulated for public comment or scrutiny;       5. "technical regulation", technical specifications, including the relevant administrative provisions, the observance of which is compulsory, de jure or de facto, in the case of marketing or use in a Member State or a major part thereof, except those laid down by local authorities;       6. "draft technical regulation", the text of a technical specification including administrative provisions, formulated with the aim of enacting it or of ultimately having it enacted as a technical regulation, the text being at a stage or preparation at which substantial amendments can still be made;       7. "product", industrially manufactured products other than agricultural products within the meaning of Article 38 (1) of the Treaty, products for human or animal consumption, medicinal products within the meaning of Directive 65/65/EEC  (1) and cosmetic products within the meaning of Directive 76/768/EEC (2).          Article 2 1. The Commission and the standards institutions in List 1 annexed hereto shall be informed each year, not later than 31 January, of the standards programmes drawn up by the national institutions in List 2 annexed hereto. This information shall be brought up to date every quarter. The Commission may amend or supplement these lists on the basis of communications from the Member States.  2. Standards programmes shall indicate in particular whether the standard:    - will be the transposition in full of an existing international or European standard,       - will be the transposition of an international or European standard incorporating certain national divergences or amendments,       - will be a new national standard,       - will constitute an amendment of a national standard.         After consulting the Committee referred to in Article 5, the Commission may draw up rules for the codified presentation of this information and a plan and criteria for the presentation of standards programmes designed to facilitate their comparison.  3. The Commission shall keep this information at the disposal of the Member States in a form in which the different programmes can be compared.   Article 3 The Commission and the standards institutions shall be informed if one or more standards institutions:  (1) OJ No 22, 9.2.1965, p. 369/65. (2) OJ No L 262, 27.9.1976, p. 169.     - wish to be involved passively or actively (by sending an observer) in activities planned by other standards institutions,       - wish a European standard or any other document leading to uniform technical specifications to be drawn up.          Article 4 At least every four months the standards institutions referred to in List 1 and the Commission shall receive all new draft standards, except where such standards merely transpose the full text of an international or European standard.  When a draft is communicated it shall be indicated whether the standard will be:    - the transposition of an international or European standard incorporating certain national divergences or amendments,       - a new national standard, or       - an amendment of a national standard.          Article 5 A Standing Committee shall be set up consisting of representatives appointed by the Member States who may call on the assistance of experts or advisers ; its chairman shall be a representative of the Commission.  The Committee shall draw up its own rules of procedure.   Article 6 1. The Committee shall meet at least twice a year with the representatives of the standards institutions referred to in List 1.  2. The Commission shall submit to the Committee a report on the implementation and application of the abovementioned procedures and proposals aimed at eliminating existing or foreseeable barriers to trade.  3. The Committee shall express its opinion on the communications and proposals referred to in paragraph 2 and may in this connection propose, in particular, that the Commission:    - request the European standards institutions to draw up a European standard within a given time limit,       - ensure where necessary, in order to avoid the risk of barriers to trade, that initially the Member States concerned decide amongst themselves on appropriate measures,       - take all appropriate measures.         4. The Committee must be consulted by the Commission:    (a) before any amendment is made to the lists in the Annex (Article 2 (1));       (b) when drawing up the rules for the codified presentation of information and the plan and criteria for the presentation of standards programmes (Article 2 (2));       (c) when deciding on the actual system whereby the exchange of information provided for in this Directive is to be effected and on any change to it;       (d) when reviewing the operation of the system set up by this Directive (Article 11).         5. The Committee may be consulted by the Commission on any preliminary draft technical regulation received by the latter.  6. Any question regarding the implementation of this Directive may be submitted to the Committee at the request of its chairman or of a Member State.  7. The proceedings of the Committee and the information to be submitted to it shall be confidential.  However, the Committee and the national authorities may, provided that the necessary precautions are taken, consult, for an expert opinion, natural or legal persons, including persons in the private sector.   Article 7 1. Member States shall take all appropriate measures to ensure that their standards institutions do not draw up or introduce standards in the field in question while the European standard referred to in the first indent of Article 6 (3) is being drawn up. This undertaking shall lapse unless a European standard has been introduced within six months following expiry of the time limit fixed in accordance with the said indent.  2. Paragraph 1 shall not apply to the work of standards institutions undertaken at the request of the  public authorities to draw up technical specifications or a standard for specific products for the purpose of enacting a technical regulation for such products.  Member States shall communicate all requests of the kind referred to in the preceding subparagraph to the Commission as draft technical regulations, in accordance with Article 8 (1), and shall state the grounds for their enactment.   Article 8 1. Member States shall immediately communicate to the Commission any draft technical regulation, except where such technical regulation merely transposes the full text of an international or European standard, in which case information regarding the relevant standard shall suffice ; they shall also let the Commission have a brief statement of the grounds which make the enactment of such a technical regulation necessary, where these are not already made clear in the draft.  The Commission shall immediately notify the other Member States of any draft it has received ; it may also refer this draft to the Committee for its opinion.  2. The Commission and the Member States may make comments to the Member State which has forwarded a draft technical regulation ; that Member State shall take such comments into account as far as possible in the subsequent preparation of the technical regulation.  3. At the express request of a Member State or the Commission, Member States shall communicate to them, without delay, the definitive text of a technical regulation.  4. The information supplied under this Article shall be confidential.  However, the Committee and the national authorities may, provided that the necessary precautions are taken, consult, for an expert opinion, natural or legal persons, including persons in the private sector.   Article 9 1. Without prejudice to paragraph 2, Member States shall postpone the adoption of a draft technical regulation for six months from the date of the notification referred to in Article 8 (1) if the Commission or another Member State delivers a detailed opinion, within three months of that date, to the effect that the measure envisaged must be amended in order to eliminate or reduce any barriers which it might create to the free movement of goods.  2. The period in paragraph 1 shall be 12 months if, within three months following the notification referred to in Article 8 (1), the Commission gives notice of its intention of proposing or adopting a Directive on the subject.  3. Paragraphs 1 and 2 shall not apply in those cases where, for urgent reasons relating to the protection of public health or safety, a Member State is obliged to prepare technical regulations in a very short space of time in order to enact and introduce them immediately without any consultations being possible. In such cases the Member State in question shall in the notification provided for in Article 8 state the grounds warranting the urgent adoption of the measures.   Article 10 Articles 8 and 9 shall not apply where Member States honour their obligations arising out of Community Directives or commitments arising out of an international agreement where they result in the adoption of uniform technical specifications in the Community.   Article 11 No later than four years following the date of notification of this Directive the Commission, in close cooperation with the Committee referred to in Article 5, shall review the operation of the procedures laid down in this Directive and, if need be, submit any relevant proposals for amending them.   Article 12 1. Member States shall bring into force the measures necessary in order to comply with this Directive within 12 months following its notification and shall forthwith inform the Commission thereof.  2. Member States shall ensure that the texts of the main provisions of national law which they adopt in the field governed by this Directive are communicated to the Commission.   Article 13 This Directive is addressed to the Member States.     Done at Brussels, 28 March 1983.  For the Council  The President  J. ERTL     ANNEX LIST 1 Standards institutions  AFNOR (France) : Association française de normalisation, Tour Europe, Cedex 7, F-92080 Paris-La-Défense  UTE (France) : Union technique de l'électricité (UTE), 12, place des États-Unis, F-75703 Paris Cedex 16  BSI (United Kingdom) : British Standards Institution, 2 Park Street, UK-London W1A 2BS  BEC (United Kingdom) : British Electrotechnical Committee, British Standards Institution, 2 Park Street, UK-London W1A 2BS  DS (Denmark) : Dansk Standardiseringsråd, Aurehøjvej 12, Postboks 77, DK-2900 Hellerup 12  DEK (Denmark) : Dansk Elektroteknisk Komite (DEK), Strandgade 36 st., DK-1401 København K  DIN (Germany) : DIN Deutsches Institut für Normung e.v., Burggrafenstrasse 4-10, Postfach 1107, D-1000 Berlin 30  DKE (Germany) : Deutsche Elektrotechnische Kommission im DIN und VDE (DKE), Stresemannallee 15, D-6000 Frankfurt am Main 70  ELOT (Greece) : Hellenic Organization for Standardization (ELOT), Didotou 15, GR-Athens 144  IBN (Belgium) : Institut belge de normalisation, Belgisch Instituut voor Normalisatie 29, avenue de la Brabançonne (laan) B-1040 Bruxelles/Brussel  CEB (Belgium) : Comité électrotechnique (CEB) (Belgisch Elektrotechnische Comité (BEC)), 3, galerie Ravenstein, bte 11, B-1000 Bruxelles  IIRS (Ireland) : Institute for Industrial Research and Standards, Ballymun Road, IRL-Dublin 9  ETCI (Ireland) : Electro-Technical Council of Ireland (ETCI), Institute for Industrial Research and Standards, Ballymun Road, IRL-Dublin 9  Luxembourg : Inspection du travail et des mines, 2, rue des Girondins, L-Luxembourg  NNI (Netherlands) : Nederlands Normalisatie Instituut, Postbus 5059, NL-2600 GB Delft  NEC (Netherlands) : Nederlands Elektrotechnisch Comité (NEC), Kalfjeslaan 2, NL-2623 AA Delft T  UNI (Italy) : Ente nazionale italiano di unificazione, piazza Armando Diaz 2, I-20123 Milano  CEI (Italy) : Comitato elettrotecnico italiano (CEI), viale Monza 259, I-20126 Milano  CEN : Comité européen de normalisation, rue de Brederode, Bruxelles  CENELEC : Comité européen de normalisation electrotechnique, rue de Brederode, Bruxelles  LIST 2 National standards institutions in the Member States of the European Community (Same as those in List 1 except for CEN and CENELEC)


Avis juridique important

|

31981L0577

Council Directive 81/577/EEC of 20 July 1981 amending Council Directive 74/408/EEC on the approximation of the laws of the Member States relating to the interior fittings of motor vehicles (strength of seats and of their anchorages)

Official Journal L 209 , 29/07/1981 P. 0034 - 0034 Finnish special edition: Chapter 13 Volume 11 P. 0151  Spanish special edition: Chapter 13 Volume 11 P. 0217  Swedish special edition: Chapter 13 Volume 11 P. 0151  Portuguese special edition Chapter 13 Volume 11 P. 0217

COUNCIL DIRECTIVE of 20 July 1981 amending Council Directive 74/408/EEC on the approximation of the laws of the Member States relating to the interior fittings of motor vehicles (strength of seats and of their anchorages) (81/577/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Council Directive 74/408/EEC of 22 July 1974 on the approximation of the laws of the Member States relating to the interior fittings of motor vehicles (strength of seats and of their anchorages) (4) does not permit EEC type-approval of a vehicle concerning the strength of the seats and of their anchorages if these seats have built-in safety belt anchorages;  Whereas in the interests of road safety, Directive 74/408/EEC should be amended without delay for vehicles with seats fitted with one or more belt anchorages, in order to make them more comfortable to use by a larger number of adult occupants and thus increase the rate of belt wearing ; whereas such an amendment has been made possible by technical progress in motor-vehicle construction,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Directive 74/408/EEC shall be amended as follows:  1. Article 1 (2) is replaced by the following:  "2. This Directive does not apply to folding (tip-up) seats or to side-facing or rearward-facing seats."   2. Section 2.7 of Annex I is replaced by the following.  "2.7. "Folding (tip-up) seat" means an auxiliary seat intended for occasional use and which is normally folded out of the way."      Article 2 Member States shall bring into force the provisions necessary in order to comply with this Directive within six months of its notification. They shall forthwith inform the Commission thereof.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 20 July 1981.  For the Council  The President  P. WALKER  (1) OJ No C 87, 9.4.1980, p. 7. (2) OJ No C 265, 13.10.1980, p. 77. (3) OJ No C 230, 8.9.1980, p. 6. (4) OJ No L 221, 12.8.1974, p. 1.


Avis juridique important

|

31998L0052

Council Directive 98/52/EC of 13 July 1998 on the extension of Directive 97/80/EC on the burden of proof in cases of discrimination based on sex to the United Kingdom of Great Britain and Northern Ireland

Official Journal L 205 , 22/07/1998 P. 0066 - 0066

COUNCIL DIRECTIVE 98/52/EC of 13 July 1998 on the extension of Directive 97/80/EC on the burden of proof in cases of discrimination based on sex to the United Kingdom of Great Britain and Northern IrelandTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 100 thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the European Parliament (2),Having regard to the opinion of the Economic and Social Committee (3),Whereas the Council, acting in accordance with the Agreement on social policy annexed to Protocol 14 on social policy annexed to the EC Treaty, and in particular Article 2(2) thereof, adopted Directive 97/80/EC (4); whereas, as a result, the said Directive does not apply to the United Kingdom;Whereas the Amsterdam European Council, held on 16 and 17 June 1997, noted with approval the agreement of the Intergovernmental Conference to incorporate the Agreement on social policy in the Treaty and also noted that a means had to be found to give legal effect to the wish of the United Kingdom to accept the Directives already adopted on the basis of that Agreement and those which may be adopted before the entry into force of the Treaty of Amsterdam;Whereas, at the Council of 24 July 1997, the Council and the Commission agreed to put into effect the conclusions adopted at the Amsterdam European Council; whereas they also agreed to apply the same procedure, mutatis mutandis, to future Directives adopted on the basis of the Agreement on social policy; whereas this Directive seeks to achieve this aim by extending Directive 97/80/EC to the United Kingdom;Whereas the fact that Directive 97/80/EC is not applicable in the United Kingdom directly affects the functioning of the common market; whereas an effective implementation of the principle of equal treatment for men and women, in particular as regards the rules organizing the burden of proof in cases of discrimination based on sex, in all the Member States will improve the functioning of the common market;Whereas the adoption of this Directive will make Directive 97/80/EC applicable in the United Kingdom; whereas, from the date on which this Directive enters into force, the term 'Member States` in Directive 97/80/EC should be construed as including the United Kingdom;Whereas the United Kingdom should benefit from the same period of three years that was granted to other Member States to bring into force the necessary provisions to comply with Directive 97/80/EC,HAS ADOPTED THIS DIRECTIVE:Article 1 Without prejudice to Article 2, Directive 97/80/EC shall apply to the United Kingdom of Great Britain and Northern Ireland.Article 2 The following paragraph shall be inserted after the first paragraph of Article 7 of Directive 97/80/EC:'As regards the United Kingdom of Great Britain and Northern Ireland, the date of 1 January 2001 in paragraph 1 shall be replaced by 22 July 2001.`Article 3 This Directive shall enter into force on the day of its publication.Article 4 This Directive is addressed to the Member States.Done at Brussels, 13 July 1998.For the CouncilThe PresidentW. SCHÜSSEL(1) OJ C 332, 7. 11. 1996, p. 11.(2) OJ C 167, 1. 6. 1998.(3) OJ C 157, 25. 5. 1998, p. 64.(4) OJ L 14, 20. 1. 1998, p. 6.