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31983L0572

Council Directive 83/572/EEC of 26 October 1983 amending Directive 65/269/EEC concerning the standardization of certain rules relating to authorizations for the carriage of goods by road between Member States and the First Council Directive of 23 July 1962 on the establishment of common rules for certain types of carriage of goods by road between Member States

Official Journal L 332 , 28/11/1983 P. 0033 - 0036 Finnish special edition: Chapter 7 Volume 3 P. 0099  Spanish special edition: Chapter 07 Volume 3 P. 0175  Swedish special edition: Chapter 7 Volume 3 P. 0099  Portuguese special edition Chapter 07 Volume 3 P. 0175

COUNCIL DIRECTIVE of 26 October 1983 amending Directive 65/269/EEC concerning the standardization of certain rules relating to authorizations for the carriage of goods by road between Member States and the First Council Directive of 23 July 1962 on the establishment of common rules for certain types of carriage of goods by road between Member States (83/572/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community and in particular Article 75 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 introduction of a multilateral authorization for intra-Community removals carriage by road should ensure more efficient organization of such removals and hence increase the productivity of undertakings specialized in removals;  Whereas Directive 65/269/EEC (4), as last amended by Directive 73/169/EEC (5), should therefore be amended to include such an authorization;  Whereas the rules on intra-Community removals carriage should be combined in a single Directive ; whereas the First Council Directive of 23 July 1962 (6), as last amended by Directive 82/50/EEC (7), should therefore be amended,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Directive 65/269/EEC is hereby amended as follows:    1. In the first paragraph of Article 2 "or other" is deleted.       2. The following paragraphs are added to Article 2:  "The authorization granted for removals carriage carried out by undertakings having special staff and equipment for the purpose shall be valid for carriage between Member States and in transit through the territory of the Member States.  Such carriage shall not be subject to a quota system.  This provision does not alter the conditions to which each Member State subjects the admission of its own nationals."       3. The model authorization annexed to this Directive is added to the Annex.          Article 2 Point 4 of Annex II to the First Council Directive of 23 July 1962 is hereby deleted.   Article 3 Member States shall take the measures necessary to comply with this Directive not later than 1 January 1984. They shall forthwith inform the Commission thereof.   Article 4 This Directive is addressed to the Member States.     Done at Luxembourg, 26 October 1983.  For the Council  The President  G. MORAITIS  (1) OJ No C 307, 24.11.1982, p. 4. (2) OJ No C 277, 17.10.1983, p. 161. (3) OJ No C 90, 5.4.1983, p. 1. (4) OJ No 88, 24.5.1965, p. 1469/65. (5) OJ No L 181, 4.7.1973, p. 20. (6) OJ No 70, 6.8.1962, p. 2005/62. (7) OJ No L 27, 4.2.1982, p. 22.     ANNEX >PIC FILE= "T0025440""PIC FILE= "T0025441">


Council Directive of 14 December 1966 modifying Council Directive of 5 November 1963 relating to the approximation of laws of Member States concerning preservatives which could be used for goods intented for human consumption


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31998L0097

Directive 98/97/EC of the European Parliament and of the Council of 22 December 1998 amending Directive 76/116/EEC on the approximation of the laws of the Member States relating to fertilisers, as regards the marketing in Austria, Finland and in Sweden of fertilisers containing cadmium

Official Journal L 018 , 23/01/1999 P. 0060 - 0061

DIRECTIVE 98/97/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 December 1998 amending Directive 76/116/EEC on the approximation of the laws of the Member States relating to fertilisers, as regards the marketing in Austria, Finland and in Sweden of fertilisers containing cadmiumTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the Economic and Social Committee (2),Acting in accordance with the procedure laid down in Article 189b of the Treaty (3),Whereas Article 69 and point 4 of Annex VIII, Article 84 and point 2 of Annex X and Article 112 and point 4 of Annex XII of the 1994 Act of Accession, concerning respectively Austria, Finland and Sweden, provide that Article 7 of Directive 76/116/EEC (4), in so far as it concerns the cadmium content of fertilisers, shall not apply to those Member States before 1 January 1999 and that the said provisions of the Act of Accession will be reviewed in accordance with Community procedures before 31 December 1998;Whereas the said review cannot be completed by 31 December 1998 because of the absence in many Member States of the exposure data needed to evaluate the risks to health and the environment of cadmium in fertilisers; whereas the review needs to be continued by performing further work after this date;Whereas the further work should evaluate the risks in Member States from cadmium in fertilisers in particular to the health of vulnerable population groups and to the environment; whereas this can only be accomplished after several years;Whereas a risk assessment of cadmium within the framework of Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (5) has been launched; whereas the results will become available only after several years;Whereas, apart from the obligation to review laid down in the 1994 Act of Accession, a review of Community legislation in force can always be decided according to Community procedures; whereas Community legislation may provide for derogations for limited periods for certain Member States because of the specificity of their situations,HAVE ADOPTED THIS DIRECTIVE:Article 1 In Article 7 of Directive 76/116/EEC, the following two paragraphs shall be added:'However, Austria, Finland and Sweden may prohibit the marketing on their territory of fertilisers containing cadmium at concentrations in excess of those which were fixed nationally at the date of accession. The derogation shall apply for the period from 1 January 1999 until 31 December 2001.The Commission shall, in consultation with Member States and interested parties, review by 31 December 2001 the need for establishing provisions at Community level concerning the cadmium content of fertilisers`.Article 2 The Republic of Austria, the Republic of Finland and the Kingdom of Sweden shall adopt and publish the provisions necessary to comply with this Directive by 31 December 1998 at the latest.When the Member States referred to in the first paragraph adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.Article 3 This Directive is addressed to the Republic of Austria, the Republic of Finland and the Kingdom of Sweden.Done at Brussels, 22 December 1998.For the European ParliamentThe PresidentJ. M. GIL-ROBLESFor the CouncilThe PresidentC. EINEM(1) OJ C 108, 7. 4. 1998, p. 83.(2) OJ C 214, 10. 7. 1998, p. 15.(3) Opinion of the European Parliament of 16 July 1998 (OJ C 292, 21. 9. 1998, p. 117), Council Common Position of 13 October 1998 (OJ C 388, 14. 12. 1998, p. 1) and Decision of the European Parliament of 3 December 1998 (not yet published in the Official Journal). Council Decision of 14 December 1998.(4) OJ L 24, 30. 1. 1976, p. 21. Directive as last amended by Council Directive 97/63/EC (OJ L 335, 6. 12. 1997, p. 15).(5) OJ L 84, 5. 4. 1993, p. 1.


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31973L0080

Council Directive 73/80/EEC of 9 April 1973 fixing common rates of capital duty

Official Journal L 103 , 18/04/1973 P. 0015 - 0015 Greek special edition: Chapter 09 Volume 1 P. 0040  Spanish special edition: Chapter 09 Volume 1 P. 0044  Portuguese special edition Chapter 09 Volume 1 P. 0044

+++++( 1 ) OJ NO L 249 , 3 . 10 . 1969 , P . 25 .  ( 2 ) SEE P . 13 THIS OFFICIAL JOURNAL .  COUNCIL DIRECTIVE OF 9 APRIL 1973 FIXING COMMON RATES OF CAPITAL DUTY ( 73/80/EEC )  THE COUNCIL OF THE EUROPEAN COMMUNITIES ,  HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY , AND IN PARTICULAR ARTICLES 99 AND 100 THEREOF ;  HAVING REGARD TO THE PROPOSAL FROM THE COMMISSION ;  HAVING REGARD TO THE OPINION OF THE EUROPEAN PARLIAMENT ;  HAVING REGARD TO THE OPINION OF THE ECONOMIC AND SOCIAL COMMITTEE ;  WHEREAS ARTICLE 7 ( 2 ) OF THE COUNCIL DIRECTIVE OF 17 JULY 1969 ( 1 ) CONCERNING INDIRECT TAXES ON THE RAISING OF CAPITAL , AS AMENDED BY THE DIRECTIVE OF 9 APRIL 1973 ( 2 ) , PROVIDES THAT THE COMMISSION IS TO SUBMIT A PROPOSAL TO THE COUNCIL BEFORE 1 JANUARY 1971 TO ENABLE THE COUNCIL TO DETERMINE THE COMMON RATES OF CAPITAL DUTY ;  WHEREAS , TO MINIMIZE OBSTACLES TO THE DEVELOPMENT AND FUNCTIONING OF A COMMON MARKET FOR CAPITAL , THE RATE OF THE CAPITAL DUTY PROVIDED FOR IN THE SAID ARTICLE 7 SHOULD BE FIXED AS LOW AS POSSIBLE , ACCOUNT NONETHELESS BEING TAKEN OF THE MEMBER STATES' BUDGETARY REQUIREMENTS ;  WHEREAS THE REDUCED RATE PROVIDED FOR IN PARAGRAPH 1 ( B ) AND ( BB ) OF THE SAID ARTICLE 7 IN RESPECT OF CERTAIN COMPANY RECONSTRUCTION OPERATIONS MUST BE FIXED SUFFICIENTLY LOW TO ELIMINATE ANY CUMULATIVE EFFECTS OF CAPITAL DUTY ; WHEREAS A RATE OF 0.50 % MEETS THIS REQUIREMENTS ; WHEREAS , HOWEVER , TO ENCOURAGE SUCH RECONSTRUCTION OPERATIONS AS FAR AS POSSIBLE , THE MEMBER STATES SHOULD BE GIVEN THE OPTION OF APPLYING A RATE LOWER THAN 0.50 % ;  WHEREAS THE MEMBER STATES SHOULD BE GIVEN SUFFICIENT TIME TO INTRODUCE THE COMMON RATES OF CAPITAL DUTY ;  HAS ADOPTED THIS DIRECTIVE :  ARTICLE 1  THE RATE OF THE CAPITAL DUTY PROVIDED FOR IN ARTICLE 7 OF THE COUNCIL DIRECTIVE OF 17 JULY 1969 CONCERNING INDIRECT TAXES ON THE RAISING OF CAPITAL ( 69/335/EEC ) SHALL , WITH EFFECT FROM 1 JANUARY 1976 , BE 1 % .  ARTICLE 2  THE REDUCED RATES PROVIDED FOR IN ARTICLE 7 ( 1 ) ( B ) AND ( BB ) OF THE SAME DIRECTIVE SHALL , WITH EFFECT FROM 1 JANUARY 1976 , BE ANY RATE BETWEEN 0 % AND 0.50 % .  ARTICLE 3  THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .  DONE AT LUXEMBOURG , 9 APRIL 1973 .  FOR THE COUNCIL  THE PRESIDENT  A . LAVENS


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31980L0884

Thirty-Fourth Commission Directive 80/884/EEC of 4 September 1980 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs

Official Journal L 251 , 24/09/1980 P. 0017 - 0017

****( 1 ) OJ NO L 270 , 14 . 12 . 1970 , P . 1 .  ( 2 ) OJ NO L 185 , 18 . 7 . 1980 , P . 48 .    THIRTY-FOURTH COMMISSION DIRECTIVE   OF 4 SEPTEMBER 1980   AMENDING THE ANNEXES TO COUNCIL DIRECTIVE 70/524/EEC CONCERNING ADDITIVES IN FEEDINGSTUFFS  ( 80/884/EEC )   THE COMMISSION OF THE EUROPEAN   COMMUNITIES ,   HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY ,   HAVING REGARD TO COUNCIL DIRECTIVE 70/524/EEC OF 23 NOVEMBER 1970 CONCERNING ADDITIVES IN FEEDING-STUFFS ( 1 ), AS LAST AMENDED BY 33RD COMMISSION DIRECTIVE 80/678/EEC ( 2 ), AND IN PARTICULAR ARTICLE 6 THEREOF ,   WHEREAS DIRECTIVE 70/524/EEC PROVIDES FOR THE CONTENT OF ITS ANNEXES TO BE REGULARLY AMENDED TO TAKE ACCOUNT OF DEVELOPMENTS IN SCIENTIFIC AND TECHNICAL KNOWLEDGE ;   WHEREAS , UNDER THE 33RD COMMISSION DIRECTIVE CERTAIN NEW USES OF SPIRAMYCIN WILL BE AUTHORIZED THROUGHOUT THE COMMUNITY AS FROM 30 NOVEMBER 1980 ; WHEREAS AUTHORIZATIONS FOR NATIONAL USE SHOULD THEREFORE BE EXTENDED UNTIL 29 NOVEMBER 1980 ;   WHEREAS THE MEASURES PROVIDED FOR IN THIS DIRECTIVE ARE IN ACCORDANCE WITH THE OPINION OF THE STANDING COMMITTEE FOR FEEDINGSTUFFS ,   HAS ADOPTED THIS DIRECTIVE :   ARTICLE 1   IN ANNEX II OF DIRECTIVE 70/524/EEC , IN PART A  ' ANTIBIOTICS '  UNDER POINT 20 ' SPIRAMYCIN ' , ' 30 JUNE 1980 '  IS REPLACED BY ' 29 NOVEMBER 1980 ' .   ARTICLE 2   THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .   DONE AT BRUSSELS , 4 SEPTEMBER 1980 .   FOR THE COMMISSION   FINN GUNDELACH   VICE-PRESIDENT


title: Directive 2006/44/EC of the European Parliament and of the Council of 6 September 2006 on the quality of fresh waters needing protection or improvement in order to support fish life   (Text with EEA relevance)

text:
               25.9.2006

               EN

               Official Journal of the European Union

               L 264/20

      DIRECTIVE 2006/44/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 6 September 2006
   on the quality of fresh waters needing protection or improvement in order to support fish life
   (codified version)
   (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 175(1) 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,
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               Council Directive 78/659/EEC of 18 July 1978 on the quality of fresh waters needing protection or improvement in order to support fish life (3) has been significantly amended on several occasions (4). In the interests of clarity and rationality that Directive should be codified.

               (2)

               The protection and improvement of the environment necessitates concrete measures to protect waters against pollution, including fresh waters capable of supporting fish life.

               (3)

               It is necessary from the ecological and economic viewpoint to safeguard fish populations from various harmful consequences resulting from the discharge of pollutant substances into the waters, such as, in particular, the reduction in number of fish belonging to a certain species and even in some cases the disappearance of a number of these species.

               (4)

               Decision No 1600/2002/EC of the European Parliament and of the Council of 22 July 2002 laying down the Sixth Community Environment Action Programme (5) is designed to achieve levels of surface water quality that do not give rise to significant impacts on, and risks to, the environment.

               (5)

               Discrepancies between the provisions applicable in the various Member States with regard to the quality of fresh water capable of supporting fish life may give rise to unequal conditions of competition and thus have a direct bearing on the functioning of the internal market.

               (6)

               In order to attain the objectives of this Directive, Member States should designate the waters to which it will apply and set limit values corresponding to certain parameters. The waters so designated should be brought into conformity with these values within five years of this designation.

               (7)

               Provision should be made that fresh waters capable of supporting fish life will, under certain conditions, be deemed to conform to the relevant parametric values even if a certain percentage of samples taken does not comply with the limits specified.

               (8)

               To ensure that the quality of fresh waters capable of supporting fish life is checked, a minimum number of samples should be taken and the measurements relating to specified parameters, as annexed hereto, should be carried out. Such sampling may be reduced or discontinued in the light of the quality of the water.

               (9)

               Member States are unable to control certain natural circumstances and it is therefore necessary to provide for the possibility of derogating from this Directive in certain cases.

               (10)

               Technical and scientific progress may call for the rapid adaptation of certain of the requirements laid down in Annex I. In order to facilitate the introduction of the measures required for this purpose, a procedure should be laid down whereby close cooperation would be established between Member States and the Commission in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6).

               (11)

               This Directive should be without prejudice to the obligations of the Member States relating to the time limits for transposition into national law of the Directives set out in Part B of Annex III,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   1.   This Directive concerns the quality of fresh waters and shall apply to those waters designated by the Member States as needing protection or improvement in order to support fish life.
   2.   This Directive shall not apply to waters in natural or artificial fish ponds used for intensive fish-farming.
   3.   The aim of this Directive is to protect or improve the quality of those running or standing fresh waters which support, or which, if pollution were reduced or eliminated, would become capable of supporting, fish belonging to:

               (a)

               indigenous species offering a natural diversity;

               (b)

               species the presence of which is judged desirable for water management purposes by the competent authorities of the Member States.

         4.   For the purposes of this Directive:

               (a)

               salmonid waters shall mean waters which support or become capable of supporting fish belonging to species such as salmon (Salmo salar), trout (Salmo trutta), grayling (Thymallus thymallus) and whitefish (Coregonus);

               (b)

               cyprinid waters shall mean waters which support or become capable of supporting fish belonging to the cyprinids (Cyprinidae), or other species such as pike (Esox lucius), perch (Perca fluviatilis) and eel (Anguilla anguilla).

         Article 2
   The physical and chemical parameters applicable to the waters designated by the Member States are listed in Annex I.
   For the purposes of applying these parameters, waters are divided into salmonid waters and cyprinid waters.
   Article 3
   1.   Member States shall, for the designated waters, set values for the parameters listed in Annex I, in so far as values are listed in column G or in column I. They shall comply with the comments contained in each of these two columns.
   2.   Member States shall not set values less stringent than those listed in column I of Annex I and shall endeavour to respect the values in column G taking into account the principle set out in Article 8.
   Article 4
   1.   Member States shall designate salmonid waters and cyprinid waters and may subsequently make additional designations.
   2.   Member States may revise the designation of certain waters owing to factors unforeseen at the time of designation, taking into account the principle set out in Article 8.
   Article 5
   Member States shall establish programmes in order to reduce pollution and to ensure that designated waters conform, within five years following designation in accordance with Article 4, to both the values set by the Member States in accordance with Article 3 and the comments contained in columns G and I of Annex I.
   Article 6
   1.   For the purposes of implementing Article 5, the designated waters shall be deemed to conform to this Directive if samples of such waters, taken at the minimum frequency specified in Annex I at the same sampling point and over a period of 12 months, show that they conform to both the values set by the Member States in accordance with Article 3 and the comments contained in columns G and I of Annex I, in the case of:

               (a)

               95 % of the samples for the parameters: pH, BOD5, nitrites, non-ionised ammonia, total ammonium, total residual chlorine, total zinc and dissolved copper. When the sampling frequency is lower than one sample per month, both the abovementioned values and comments shall be respected for all the samples;

               (b)

               the percentages listed in Annex I for the parameters: temperature and dissolved oxygen;

               (c)

               the average concentration set for the parameter: suspended solids.

         2.   Instances in which the values set by Member States in accordance with Article 3 or the comments contained in columns G and I of Annex I are not respected shall not be taken into consideration in the calculation of the percentages provided for in paragraph 1 when they are the result of floods or other natural disasters.
   Article 7
   1.   The competent authorities in the Member States shall carry out sampling operations, the minimum frequency of which is laid down in Annex I.
   2.   Where the competent authority records that the quality of designated waters is appreciably higher than that which would result from the application of the values set in accordance with Article 3 and the comments contained in columns G and I of Annex I, the frequency of the sampling may be reduced. Where there is no pollution or no risk of deterioration in the quality of the waters, the competent authority concerned may decide that no sampling is necessary.
   3.   If sampling shows that a value set by a Member State in accordance with Article 3 or a comment contained in columns G or I of Annex I is not respected, the Member State shall establish whether this is the result of chance, a natural phenomenon or pollution and shall adopt appropriate measures.
   4.   The exact sampling point, the distance from this point to the nearest point where pollutants are discharged and the depth at which the samples are to be taken shall be fixed by the competent authority of each Member State on the basis of local environmental conditions in particular.
   5.   Certain reference methods of analysis for calculating the value of the parameters concerned are set out in Annex I. Laboratories which employ other methods shall ensure that the results obtained are equivalent or comparable to those specified in Annex I.
   Article 8
   Implementation of the measures taken pursuant to this Directive may on no account lead, either directly or indirectly, to increased pollution of fresh water.
   Article 9
   Member States may at any time set more stringent values for designated waters than those laid down in this Directive. They may also lay down provisions relating to parameters other than those provided for in this Directive.
   Article 10
   When fresh waters cross or form national frontiers between Member States and which one of the States concerned is considering designating, the States concerned shall consult each other in order to determine the stretches of such waters to which this Directive might apply and the consequences to be drawn from the common quality objectives; these consequences shall be determined, after formal consultations, by each State concerned. The Commission may participate in these deliberations.
   Article 11
   Member States may derogate from this Directive:

               (a)

               in the case of certain parameters marked (0) in Annex I, because of exceptional weather or special geographical conditions;

               (b)

               when designated waters undergo natural enrichment in certain substances, so that the values set out in Annex I are not respected.
               Natural enrichment means the process whereby, without human intervention, a given body of water receives from the soil certain substances contained therein.

         Article 12
   Such amendments as are necessary for adapting to technical and scientific progress the G values for the parameters and the methods of analysis contained in Annex I shall be adopted in accordance with the procedure referred to in Article 13(2).
   Article 13
   1.   The Commission shall be assisted by a committee on adaptation to technical and scientific progress, hereinafter referred to as ‘the Committee’.
   2.   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.
   3.   The Committee shall adopt its rules of procedure.
   Article 14
   For the purposes of applying this Directive, Member States shall provide the Commission with information concerning:

               (a)

               the waters designated in accordance with Article 4(1), in summary form;

               (b)

               the revision of the designation of certain waters in accordance with Article 4(2);

               (c)

               the provisions laid down in order to establish new parameters in accordance with Article 9;

               (d)

               the application of the derogations from the values listed in column I of Annex I.

         More generally, Member States shall provide the Commission, on a reasoned request from the latter, with any information necessary for the application of this Directive.
   Article 15
   At intervals of three years, and for the first time for the period 1993 to 1995 inclusive, Member States shall send information to the Commission on the implementation of this Directive, in the form of a sectoral report which shall also cover other pertinent Community Directives. The report shall be drawn up on the basis of a questionnaire or outline drafted by the Commission in accordance with the procedure referred to in Article 6 of Council Directive 91/692/EEC of 23 December 1991 standardising and rationalising reports on the implementation of certain Directives relating to the environment (7). The questionnaire or outline shall be sent to the Member States six months before the start of the period covered by the report. The report shall be sent to the Commission within nine months of the end of the three-year period covered by it.
   The Commission shall publish a Community report on the implementation of this Directive within nine months of receiving the reports from the Member States.
   Article 16
   Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.
   Article 17
   Directive 78/659/EEC is hereby repealed, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law of the Directives set out in Part B of Annex III.
   References to the repealed Directive shall be construed as references to this Directive and should be read in accordance with the correlation table in Annex IV.
   Article 18
   This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
   Article 19
   This Directive is addressed to the Member States.

      Done at Strasbourg, 6 September 2006.

            For the European Parliament

            The President

         J. BORRELL FONTELLES

            For the Council

            The President

         P. LEHTOMÄKI

      (1)  OJ C 117, 30.4.2004, p. 11.

      (2)  Opinion of the European Parliament of 21 April 2004 (OJ C 104 E, 30.4.2004, p. 545) and Council Decision of 25 April 2006.

      (3)  OJ L 222, 14.8.1978, p. 1. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

      (4)  See Part A of Annex III.

      (5)  OJ L 242, 10.9.2002, p. 1.

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

      (7)  OJ L 377, 31.12.1991, p. 48. 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).

      ANNEX I
      LIST OF PARAMETERS

                  Parameter

                  Salmonid waters

                  Cyprinid waters

                  Methods of analysis or inspection

                  Minimum sampling and measuring frequency

                  Observations

                  G

                  I

                  G

                  I

                              1.

                              Temperature (°C)

                  1.

                  Temperature measured downstream of a point of thermal discharge (at the edge of the mixing zone) must not exceed the unaffected temperature by more than:

                  Thermometry

                  Weekly, both upstream and downstream of the point of thermal discharge

                  Over-sudden variations in temperature shall be avoided

                  1,5 °C

                  3 °C

                  Derogations limited in geographical scope may be decided by Member States in particular conditions if the competent authority can prove that there are no harmful consequences for the balanced development of the fish population

                  2.

                  Thermal discharges must not cause the temperature downstream of the point of thermal discharge (at the edge of the mixing zone) to exceed the following:

                  21,5 (0)

                  28 (0)

                  10 (0)

                  10 (0)

                  The 10 °C temperature limit applies only to breeding periods of species which need cold water for reproduction and only to waters which may contain such species

                  Temperature limits may, however, be exceeded for 2 % of the time.

                              2.

                              Dissolved oxygen
                              (mg/l O2)

                  50 % ≥ 9
                  100 % ≥ 7

                  50 % ≥ 9

                  50 % ≥ 8
                  100 % ≥ 5

                  50 % ≥ 7

                  Winkler's method or specific electrodes (electro-chemical method)

                  Monthly, minimum one sample representative of low oxygen conditions of the day of sampling
                  However, where major daily variations are suspected, a minimum of two day samples in one day shall be taken

                  When the oxygen concentration falls below 6 mg/l, Member States shall implement the provisions of Article 7(3). The competent authority must prove that this situation will have no harmful consequences for the balanced development of the fish population

                  When the oxygen concentration falls below 4 mg/l, Member States shall implement the provisions of Article 7(3). The competent authority must prove that this situation will have no harmful consequences for the balanced development of the fish population

                              3.

                              pH

                  6 to 9 (0) (1)

                  6 to 9 (0) (1)

                  Electrometry calibration by means of two solutions with known pH values, preferably on either side of, and close to the pH being measured

                  Monthly

                              4.

                              Suspended solids
                              (mg/l)

                  ≤ 25 (0)

                  ≤ 25 (0)

                  Filtration through a 0,45 μm filtering membrane, or centrifugation (five minutes minimum, average acceleration of 2 800 to 3 200 g) drying at 105 °C and weighing

                  The values shown are average concentrations and do not apply to suspended solids with harmful chemical properties
                  Floods are liable to cause particularly high concentrations

                              5.

                              BOD5

                              (mg/l O2)

                  ≤ 3

                  ≤ 6

                  Determination of O2 by the Winkler method before and after five days incubation in complete darkness at 20 ± 1 °C (nitrification should not be inhibited)

                              6.

                              Total phosphorus
                              (mg/l P)

                  Molecular absorption spectrophotometry

                  In the case of lakes of average depth between 18 and 300 m, the following formula could be applied:

                  where:

                  L

                  =

                  loading expressed as mg P per square metre lake surface in one year

                  =

                  mean depth of lake in metres

                  Tw

                  =

                  theoretical renewal time of lake water in years

                  In other cases limit values of 0,2 mg/l for salmonid and of 0,4 mg/l for cyprinid waters, expressed as PO4, may be regarded as indicative in order to reduce eutrophication

                              7.

                              Nitrites
                              (mg/l NO2)

                  ≤ 0,01

                  ≤ 0,03

                  Molecular absorption spectrophotometry

                              8.

                              Phenolic compounds
                              (mg/l C6H5OH)

                      (2)

                      (2)

                  By taste

                  An examination by taste shall be made only where the presence of phenolic compounds is presumed

                              9.

                              Petroleum hydrocarbons

                      (3)

                      (3)

                  Visual
                  By taste

                  Monthly

                  A visual examination shall be made regularly once a month, with an examination by taste only where the presence of hydrocarbons is presumed

                              10.

                              Non-ionised ammonia
                              (mg/l NH3)

                  ≤ 0,005

                  ≤ 0,025

                  ≤ 0,005

                  ≤ 0,025

                  Molecular absorption spectrophotometry using indophenol blue or Nessler's method associated with pH and temperature determination

                  Monthly

                  Values for non-ionised ammonia may be exceeded in the form of minor peaks in the daytime

                  In order to diminish the risk of toxicity due to non-ionised ammonia, of oxygen consumption due to nitrification and of eutrophication, the concentrations of total ammonium should not exceed the following:

                              11.

                              Total ammonium
                              (mg/l NH4)

                  ≤ 0.04

                  ≤ 1 (4)

                  ≤ 0.2

                  ≤ 1 (4)

                              12.

                              Total residual chlorine
                              (mg/l HOCl)

                  ≤ 0,005

                  ≤ 0,005

                  DPD-method (dietyl-p-phenylenediamene)

                  Monthly

                  The I-values correspond to pH = 6
                  Higher concentrations of total chlorine can be accepted if the pH is higher

                              13.

                              Total zinc
                              (mg/l Zn)

                  ≤ 0,3

                  ≤ 1,0

                  Atomic absorption spectrometry

                  Monthly

                  The I-values correspond to a water hardness of 100 mg/l CaCO3

                  For hardness levels between 10 and 500 mg/l corresponding limit values can be found in Annex II

                              14.

                              Dissolved copper
                              (mg/l Cu)

                  ≤ 0,04

                  ≤ 0,04

                  Atomic absorption spectrometry

                  The G-values correspond to a water hardness of 100 mg/l CaCO3

                  For hardness levels between 10 and 300 mg/l corresponding limit values can be found in Annex II

            General observation:
      It should be noted that the parametric values listed in this Annex assume that the other parameters, whether mentioned in this Annex or not, are favourable. This implies, in particular, that the concentrations of other harmful substances are very low.
      Where two or more harmful substances are present in mixture, joint effects (additive, synergic or antagonistic effects) may be significant.
      Abbreviations:

                  G

                  =

                  guide.

                  I

                  =

                  mandatory.

                  (0)

                  =

                  derogations are possible in accordance with Article 11.

         (1)  Artificial pH variations with respect to the unaffected values shall not exceed ±0,5 of a pH unit within the limits falling between 6,0 and 9,0 provided that these variations do not increase the harmfulness of other substances present in the water.

         (2)  Phenolic compounds must not be present in such concentrations that they adversely affect fish flavour.

         (3)  Petroleum products must not be present in water in such quantities that they:

                  —

                  form a visible film on the surface of the water or form coatings on the beds of water-courses and lakes,

                  —

                  impart a detectable ‘hydrocarbon’ taste to fish,

                  —

                  produce harmful effects in fish.

         (4)  In particular geographical or climatic conditions and particularly in cases of low water temperature and of reduced nitrification or where the competent authority can prove that there are no harmful consequences for the balanced development of the fish population, Member States may fix values higher than 1 mg/l.

      ANNEX II
      PARTICULARS REGARDING TOTAL ZINC AND DISSOLVED COPPER
      Total zinc
      (see Annex I, No 13, ‘Observations’ column)
      Total zinc concentrations (mg/l Zn) for different water hardness values between 10 and 500 mg/l CaCO3:

                  Water hardness (mg/l CaCO3)

                  10

                  50

                  100

                  500

                  Salmonid waters (mg/l Zn)

                  0,03

                  0,2

                  0,3

                  0,5

                  Cyprinid waters (mg/l Zn)

                  0,3

                  0,7

                  1,0

                  2,0

            Dissolved copper
      (See Annex I, No 14, ‘Observations’ column)
      Dissolved copper concentrations (mg/l Cu) for different water hardness values between 10 and 300 mg/l CaCO3:

                  Water hardness (mg/l CaCO3)

                  10

                  50

                  100

                  300

                  mg/l Cu

                  0,005 (1)

                  0,022

                  0,04

                  0,112

         (1)  The presence of fish in waters containing higher concentrations of copper may indicate a predominance of dissolved organo-cupric complexes.

      ANNEX III
      Part A
      Repealed Directive with its successive amendments
      (referred to in Article 17)

                  Council Directive 78/659/EEC (OJ L 222, 14.8.1978, p. 1) (1)

                  Council Directive 91/692/EEC (OJ L 377, 31.12.1991, p. 48)

                  Annex I, point (c) only

                  Council Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36)

                  Annex III, point 26 only

            Part B
      List of time-limits for transposition into national law
      (referred to in Article 17)

                  Directive

                  Time-limit for transposition

                  78/659/EEC

                  20 July 1980

                  91/692/EEC

                  1 January 1993

         (1)  Directive 78/659/EEC has also been amended by the following unrepealed acts:

                  —

                  the 1979 Act of Accession,

                  —

                  the 1985 Act of Accession,

                  —

                  the 1994 Act of Accession.

      ANNEX IV
      CORRELATION TABLE

                  Directive 78/659/EEC

                  This Directive

                  Article 1(1) and (2)

                  Article 1(1) and (2)

                  Article 1(3), introductory phrase

                  Article 1(3), introductory phrase

                  Article 1(3), first indent

                  Article 1(3)(a)

                  Article 1(3), second indent

                  Article 1(3)(b)

                  Article 1(4), introductory phrase

                  Article 1(4), introductory phrase

                  Article 1(4), first indent

                  Article 1(4)(a)

                  Article 1(4), second indent

                  Article 1(4)(b)

                  Article 2(1)

                  Article 2, first subparagraph

                  Article 2(2)

                  Article 2, second subparagraph

                  Article 3

                  Article 3

                  Article 4(1) and (2)

                  Article 4(1)

                  Article 4(3)

                  Article 4(2)

                  Article 5

                  Article 5

                  Article 6(1), introductory phrase

                  Article 6(1), introductory phrase

                  Article 6(1), first indent

                  Article 6(1)(a)

                  Article 6(1), second indent

                  Article 6(1)(b)

                  Article 6(1), third indent

                  Article 6(1)(c)

                  Article 6(2)

                  Article 6(2)

                  Article 7

                  Article 7

                  Article 8

                  Article 8

                  Article 9

                  Article 9

                  Article 10

                  Article 10

                  Article 11

                  Article 11

                  Article 12

                  Article 12

                  Article 13(1) and Article 14

                  Article 13

                  Article 15, first subparagraph, introductory phrase

                  Article 14, first subparagraph, introductory phrase

                  Article 15, first subparagraph, first indent

                  Article 14, first subparagraph, point (a)

                  Article 15, first subparagraph, second indent

                  Article 14, first subparagraph, point (b)

                  Article 15, first subparagraph, third indent

                  Article 14, first subparagraph, point (c)

                  Article 15, first subparagraph, fourth indent

                  Article 14, first subparagraph, point (d)

                  Article 15, second subparagraph

                  Article 14, second subparagraph

                  Article 16

                  Article 15

                  Article 17(1)

                  —

                  Article 17(2)

                  Article 16

                  —

                  Article 17

                  —

                  Article 18

                  Article 18

                  Article 19

                  Annex I

                  Annex I

                  Annex II

                  Annex II

                  —

                  Annex III

                  —

                  Annex IV


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31999L0023

Commission Directive 1999/23/EC of 9 April 1999 adapting to technical progress Council Directive 93/33/EEC on protective devices intended to prevent the unauthorised use of two- or three-wheel motor vehicles (Text with EEA relevance)

Official Journal L 104 , 21/04/1999 P. 0013 - 0015

COMMISSION DIRECTIVE 1999/23/ECof 9 April 1999adapting to technical progress Council Directive 93/33/EEC on protective devices intended to prevent the unauthorised use of two- or three-wheel motor vehicles(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two- or three-wheel motor vehicles(1), as amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 16 thereof,Having regard to Council Directive 93/33/EEC of 14 June 1993 on protective devices intended to prevent the unauthorised use of two- or three-wheel motor vehicles(2), and in particular Article 4 thereof,(1) Whereas Directive 93/33/EEC is one of the separate Directives of the Community type-approval procedure introduced by Directive 92/61/EEC; whereas the provisions of Directive 92/61/EEC relating to vehicle systems, components and technical units therefore apply to that Directive;(2) Whereas developments in technology now permit an adaptation of Council Directive 93/33/EEC to technical progress; whereas in order to ensure the proper functioning of the type-approval system as a whole, it is therefore necessary to clarify or complete certain provisions of the Directive concerned;(3) Whereas to this end it is necessary to adapt the provisions relating to the locking angle of the steering of quadricycles and those relating to the removal of the key from type-3 devices designed to be fitted to tricycles and quadricycles; whereas, moreover, it is deemed appropriate to allow two- and three-wheel motor vehicles to be fitted with protective devices against unauthorised use which are approved for four-wheel motor vehicles;(4) Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for adaptation to technical progress set up by Article 13 of Council Directive 70/156/EEC(3), as last amended by Directive 98/91/EC of the European Parliament and of the Council(4),HAS ADOPTED THIS DIRECTIVE:Article 1Annex I to Directive 93/33/EEC is hereby amended in accordance with the Annex to this Directive.Article 21. With effect from 1 January 2000, Member States shall not, on grounds relating to protective devices intended to prevent unauthorised use:- refuse, in respect of a type of two- or three-wheel vehicle or a type of protective device intended to prevent unauthorised use, to grant EC type-approval,- prohibit the registration, sale or entry into service of two- or three-wheel motor vehicles, or the sale or entry into service of protective devices intended to prevent unauthorised use,if the protective devices intended to prevent unauthorised use comply with the requirements of Directive 93/33/EEC as amended by this Directive.2. With effect from 1 July 2000, Member States shall refuse to grant EC type-approval for any type of two- or three-wheel motor vehicle on grounds relating to protective devices intended to prevent unauthorised use or any type of protective device intended to prevent unauthorised use if the requirements of Directive 93/33/EEC, as amended by this Directive, are not fulfilled.Article 31. Member States shall adopt and publish, no later than 31 December 1999, the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.They shall apply those provisions from 1 January 2000.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. Member States shall communicate to the Commission the texts of the main provisions of national law that they adopt in the field governed by this Directive.Article 4This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.Article 5This Directive is addressed to the Member States.Done at Brussels, 9 April 1999.For the CommissionMartin BANGEMANNMember of the Commission(1) OJ L 225, 10.8.1992, p. 72.(2) OJ L 188, 29.7.1993, p. 32.(3) OJ L 42, 23.2.1970, p. 1.(4) OJ L 11, 16.1.1999, p. 25.ANNEX1. In Point 3.1 , the following new text is added: "Protective devices intended to prevent unauthorised use approved for motor vehicles in categories M1 and N1 in conformity with Directive 74/61/EEC may also be fitted to two- or three-wheel motor vehicles."2. Point 3.11 is replaced by the following: "3.11. If it is of type 1, 2 or 3 the protective device must be designed in such a way that the steering can only be locked at an angle of at least 20° to the left and/or right in relation to the straight-ahead position, with the exception of devices designed to be fitted to tricycles and quadricycles."3. Point 4.1.2. is replaced by the following: "4.1.2. In the case of type 3 protective devices it must not be possible to preload the catch via action on the part of the vehicle user combined or added to a turning of the key. Apart from the conditions provided for in Point 3.2.3 and except in the case of tricycles and quadricycles, it shall not be possible to remove the key once the catch has been preloaded."


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31992L0030

Council Directive 92/30/EEC of 6 April 1992 on the supervision of credit institutions on a consolidated basis

Official Journal L 110 , 28/04/1992 P. 0052 - 0058 Finnish special edition: Chapter 6 Volume 3 P. 0133  Swedish special edition: Chapter 6 Volume 3 P. 0133

COUNCIL DIRECTIVE 92/30/EEC  of 6 April 1992  on the supervision of credit institutions on a consolidated basisTHE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular the first and third sentences of Article 57 (2) thereof,  Having regard to the proposal from the Commission,  In cooperation with the European Parliament (1),  Having regard to the opinion of the Economic and Social Committee (2),  Whereas Council Directive 83/350/EEC of 13 June 1983 on the supervision of credit institutions on a consolidated basis (3) established the necessary framework for the introduction of supervision of credit institutions on a consolidated basis; whereas,  following the transposition of that Directive into the national law of the Member States, the principle of supervision on a consolidated basis is now applied throughout the Community;  Whereas, in order to be effective, supervision on a consolidated basis must be applied to all banking groups, including those the parent undertakings of which are not credit institutions; whereas the competent authorities must hold the necessary legal  instruments to be able to exercise such supervision;  Whereas, in the case of groups with diversified activities the parent undertakings of which control at least one credit institution subsidiary, the competent authorities must be able to assess the financial situation of a credit institution in such a  group; whereas, pending subsequent coordination, the Member States may lay down appropriate methods of consolidation for the achievement of the objective of this Directive; whereas the competent authorities must at least have the means of obtaining from  all undertakings within a group the information necessary for the performance of their function; whereas cooperation between the authorities responsible for the supervision of different financial sectors must be established in the case of groups of  undertakings carrying on a range of financial activities;  Whereas rules limiting the risks taken by a credit institution on the mixed-activity holding company of which it is a subsidiary, as well as those taken on the other subsidiaries of the same mixed-activity holding company, can be particularly useful;  whereas it would, however, appear to be preferable to settle this question in a more systematic manner in the framework of a future Directive on the limitation of large exposures;  Whereas the Member States can, furthermore, refuse or withdraw banking authorization in the case of certain group structures considered inappropriate for carrying on banking activities, in particular because such structures could not be supervised  effectively; whereas in this respect the competent authorities have the powers mentioned in Article 8 (1) (c) of the First Council Directive (77/780/EEC) of 12 December 1977 on the coordination of the laws, regulations and administrative provisions  relating to the taking up and pursuit of the business of credit institutions (4) and in Articles 5 and 11 of the Second Council Directive (89/646/EEC) of 15 December 1989 on the coordination of laws, regulations and administrative provisions relating to  the taking up and pursuit of the business of credit institutions (5), in order to ensure the sound and prudent management of credit institutions;  Whereas the Member States can equally apply appropriate supervision techniques to groups with structures not covered by this Directive; whereas, if such structures become common, this Directive should be extended to cover them;  Whereas supervision on a consolidated basis must take in all activities defined in the Annex to Directive 89/646/EEC; whereas all undertakings principally engaged in such activities must therefore be included in supervision on a consolidated basis;  whereas, as a result, the definition of a financial institution given in Directive 83/350/EEC must be widened to cover such activities;  Whereas, regarding the consolidation of financial institutions involved in activities principally subject to market risks and subject to particular rules of supervision, the coordination of the methods for the consolidated supervision of market risks is  possible in the framework of Community harmonization of capital adequacy of investment firms and credit institutions, for which the Commission has introduced a proposal for a Directive; whereas such harmonization concerns, inter alia, the conditions  which must be applied when offsetting opposing positions in the group and the case where these financial institutions are subject to specific supervisory rules regarding their financial stability; whereas this implies that, until the future Directive on  capital adequacy to cover market risks is brought into effect, the competent authorities shall include in consolidated supervision financial institutions which are principally exposed ot market risks, in accordance with methods determined by those  authorities in the light of the particular nature of the risks involved;  Whereas, following the adoption of Council Directive 86/635/EEC of 8 December 1986 on the annual accounts and consolidated accounts of banks and other financial institutions (6), which, together with the Seventh Council Directive (83/349/EEC) of 13 June  1983 on consolidated accounts (7), established the rules of consolidation applicable to consolidated accounts published by credit institutions, it is now possible to define more precisely the methods to be used in prudential supervision exercised on a  consolidated basis;  Whereas this Directive is fully in keeping with the objectives defined in the Single European Act; whereas it will, in particular, ensure the homogeneous application throughout the Community of prudential rules established by other Community  legislation, which must be observed on a consolidated basis; whereas this Directive is, in particular, necessary for the correct application of Council Directive 89/299/EEC of 17 April 1989 on the own funds of credit institutions (8);  Whereas supervision of credit institutions on a consolidated basis must be aimed at, in particular, protecting the interests of the depositors of the said institutions and at ensuring the stability of the financial system;  Whereas it is desirable that agreement should be reached, on the basis of reciprocity, between the Community and third countries with a view to allowing the practical exercise of consolidated supervision over the largest possible geographical area;  Whereas the amendments to be made to Directive 83/350/EEC are so considerable that it is preferable that it be wholly replaced by this Directive,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Definitions  For the purposes of this Directive:  - credit institution shall mean a credit institution within the meaning of the first indent of Article 1 of Directive 77/780/EEC, or any private or public undertaking which corresponds to the definition in the first indent of Article 1 of Directive  77/780/EEC and has been authorized in a third country,  - financial institution shall mean an undertaking, other than a credit institution, the principal activity of which is to acquire holdings or to carry on one or more of the activities referred to in numbers 2 to 12 of the list appearing in the Annex to  Directive 89/646/EEC,  - financial holding company shall mean a financial institution the subsidiary undertakings of which are either exclusively or mainly credit institutions or financial institutions, one at least of such subsidiaries being a credit institution,  - mixed-activity holding company shall mean a parent undertaking, other than a financial holding company or a credit institution, the subsidiaries of which include at least one credit institution,  - ancillary banking services undertaking shall mean an undertaking the principal activity of which consists in owning or managing property, managing data-processing services, or any other similar activity which is ancillary to the principal activity of  one or more credit institution,  - participation shall mean the ownership, direct or indirect, of 20 % or more of the voting rights or capital of an undertaking,   - parent undertaking shall mean a parent undertaking within the meaning of Article 1 (1) of the Directive 83/349/EEC and any undertaking which, in the opinion of the competent authorities, effectively exercises a dominant influence over another  undertaking,  - subsidiary shall mean a subsidiary undertaking within the meaning of Article 1 (1) of Directive 83/349/EEC and any undertaking over which, in the opinion of the competent authorities, a parent undertaking effectively exercises a dominant influence.  All subsidiaries of subsidiary undertakings shall also be considered subsidiaries of the undertaking that is their original parent,  - competent authorities shall mean the national authorities which are empowered by law or regulation to supervise credit institutions.  Article 2  Scope  This Directive shall apply to credit institutions that have obtained the authorization referred to in Article 3 of Directive 77/780/EEC, financial holding companies and mixed-activity holding companies which have their head offices in  the Community.  The institutions permanently excluded by Article 2 of Directive 77/780/EEC, with the exception, however, of the Member States' central banks, shall be treated as financial institutions for the purposes of this Directive.  Article 3  Supervision on a consolidated basis of credit institutions  1. Every credit institution which has a credit institution or a financial institution as a subsidiary or which holds a participation in such institutions shall be subject, to the  extent and in the manner prescribed in Article 5, to supervision on the basis of its consolidated financial situation. Such supervision shall be exercised at least in the areas referred to in paragraphs 5 and 6.  2. Every credit institution the parent undertaking of which is a financial holding company shall be subject, to the extent and in the manner prescribed in Article 5, to supervision on the basis of the consolidated financial situation of that financial  holding company. Such supervision shall be exercised at least in the areas referred to in paragraphs 5 and 6. The consolidation of the financial situation of the financial holding company shall not in any way imply that the competent authorities are  required to play a supervisory role in relation to the financial holding company standing alone.  3. The Member States or the competent authorities responsible for exercising supervision on a consolidated basis pursuant to Article 4 may decide in the cases listed below that a credit institution, financial institution or auxiliary banking services  undertaking which is a subsidiary or in which a participation is held need not be included in the consolidation:  - if the undertaking that should be included is situated in a third country where there are legal impediments to the transfer of the necessary information,  - if, in the opinion of the competent authorities, the undertaking that should be included is of negligible interest only with respect to the objectives of monitoring credit institutions and in all cases if the balance sheet total of the undertaking  that should be included is less than the smaller of the following two amounts: ECU 10 million or 1 % of the balance sheet total of the parent undertaking or the undertaking that holds the participation. If several undertakings meet the above criteria,  they must nevertheless be included in the consolidation where collectively they are of non-negligible interest with respect to the aforementioned objectives, or  - if, in the opinion of the competent authorities responsible for exercising supervision on a consolidated basis, the consolidation of the financial situation of the undertaking that should be included would be inappropriate or misleading as far as the  objectives of the supervision of credit institutions are concerned.  4. When the competent authorities of a Member State do not include a credit institution subsidiary in supervision on a consolidated basis under one of the cases provided for in the second and third indents of paragraph 3, the competent authorities of  the Member State in which that credit institution subsidiary is situated may ask the parent undertaking for information which may facilitate their supervision of that credit institution.  5. Supervision of solvency, and of the adequacy of own funds to cover market risks and control of large exposures, as governed by the relevant Community acts in force, shall be exercised on a consolidated basis in accordance with this Directive. Member  States shall adopt any measures necessary, where appropriate, to include financial holding companies in consolidated supervision, in accordance with paragraph 2.  Compliance with the limits set in Article 12 (1) and (2) of Directive 89/646/EEC shall be supervised and controlled on the basis of the consolidated or sub-consolidated financial situation of the credit institution.  6. The competent authorities shall ensure that, in all the undertakings included in the scope of the supervision on a consolidated basis that is exercised over a credit institution in implementation of paragraphs 1 and 2, there are adequate internal  control mechanisms for the production of any data and information which would be relevant for the purposes of supervision on a consolidated basis.  7. Without prejudice to specific provisions contained in other Directives, Member States may waive application, on an individual or sub-consolidated basis, of the rules laid down in paragraph 5 to a credit institution that, as a parent undertaking, is  subject to supervision on a consolidated basis, and to any subsidiary of such a credit institution which is subject to their authorization and supervision and is included in the supervision on a consolidated basis of the credit institution which is the  parent company. The same exemption option shall be allowed where the parent undertaking is a financial holding company which has its head office in the same Member State as the credit institution, provided that it is subject to the same supervision as  that exercised over credit institutions, and in particular the standards laid down in paragraph 5.  In both cases, steps must be taken to ensure that capital is distributed adequately within the banking group.  If the competent authorities do apply those rules individually to such credit institutions, they may, for the purpose of calculating own funds, make use of the provision in the last subparagraph of Article 2 (1) of Directive 89/299/EEC.  8. Where a credit institution the parent of which is a credit institution has been authorized and is situated in another Member State, the competent authorities which granted that authorization shall apply the rules laid down in paragraph 5 to that  institution on an individual or, when appropriate, a sub-consolidated basis.  9. Notwithstanding the requirements of paragraph 8, the competent authorities responsible for authorizing the subsidiary of a parent undertaking which is a credit institution may, by bilateral agreement, delegate their responsibility for supervision to  the competent authorities which authorized and supervise the parent undertaking. The Commission must be kept informed of the existence and content of such agreements. It shall forward such information to the competent authorities of the other Member  States and to the Banking Advisory Committee.  10. Member States shall provide that their competent authorities responsible for exercising supervision on a consolidated basis may ask the subsidiaries of a credit institution or a financial holding company which are not included within the scope of  supervision on a consolidated basis for the information referred to in Article 6. In such a case, the procedures for transmitting and verifying the information laid down in that Article shall apply.  Article 4  Competent authorities responsible for exercising supervision on a consolidated basis  1. Where a parent undertaking is a credit institution, supervision on a consolidated basis shall be exercised by the competent authorities that authorized  it under Article 3 of Directive 77/780/EEC.  2. Where the parent of a credit institution is a financial holding company, supervision on a consolidated basis shall be exercised by the competent authorities which authorized that credit institution under Article 3 of Directive 77/780/EEC.  However, where credit institutions authorized in two or more Member States have as their parent the same financial holding company, supervision on a consolidated basis shall be exercised by the competent authorities of the credit institution authorized  in the Member State in which the financial holding company was set up.  If no credit institution subsidiary has been authorized in the Member State in which the financial holding company was set up, the competent authorities of the Member States concerned (including those of the Member State in which the financial holding  company was set up) shall seek to reach agreement as to who amongst them will exercise supervision on a consolidated basis. In the absence of such agreement, supervision on a consolidated basis shall be exercised by the competent authorities that  authorized the credit institution with the greatest balance sheet total; if that figure is the same, supervision on a consolidated basis shall be exercised by the competent authorities which first gave the authorization referred to in Article 3 of  Directive 77/780/EEC.  3. The competent authorities concerned may by common agreement waive the rules laid down in the first and second subparagraphs of paragraph 2.  4. The agreements referred to in the third subparagraph of paragraph 2 and in paragraph 3 shall provide for procedures for cooperation and for the transmission of information such that the objectives of this Directive may be achieved.  5. Where Member States have more than one competent authority for the prudential supervision of credit institutions and financial institutions, Member States shall take the requisite measures to organize coordination between such authorities.  Article 5  Form and extent of consolidation  1. The competent authorities responsible for exercising supervision on a consolidated basis must, for the purposes of supervision, require full consolidation of all the credit institutions and financial  institutions which are subsidiaries of a parent undertaking.   However, proportional consolidation may be prescribed where, in the opinion of the competent authorities, the liability of a parent undertaking holding a share of the capital is limited to that share of the capital because of the liability of the other  shareholders or members whose solvency is satisfactory. The liability of the other shareholders and members must be clearly established, if necessary by means of formal, signed commitments.  2. The competent authorities responsible for carrying out supervision on a consolidated basis must, in order to do so, require the proportional consolidation of participations in credit institutions and financial institutions managed by an undertaking  included in the consolidation together with one or more undertakings not included in the consolidation, where those undertakings' liability is limited to the share of the capital they hold.  3. In the case of participations or capital ties other than those referred to in paragraphs 1 and 2, the competent authorities shall determine whether and how consolidation is to be carried out. In particular, they may permit or require use of the  equity method. That method shall not, however, constitute inclusion of the undertakings concerned in supervision on a consolidated basis.  4. Without prejudice to paragraphs 1, 2 and 3, the competent authorities shall determine whether and how consolidation is to be carried out in the following cases:  - where, in the opinion of the competent authorities, a credit institution exercises a significant influence over one or more credit institutions or financial institutions, but without holding a participation or other capital ties in these institutions,   - where two or more credit institutions or financial institutions are placed under single management other than pursuant to a contract or clauses of their memoranda or articles of association,  - where two or more credit institutions or financial institutions have administrative, management or supervisory bodies with the same persons constituting a majority.  In particular, the competent authorities may permit, or require use of, the method provided for in Article 12 of Directive 83/349/EEC. That method shall not, however, constitute inclusion of the undertakings concerned in consolidated supervision.  5. Where consolidated supervision is required pursuant to Article 3 (1) and (2), ancillary banking services undertakings shall be included in consolidations in the cases, and in accordance with the methods, laid down in paragraphs 1 to 4, of this  Article.  Article 6  Information to be supplied by mixed-activity holding companies and their subsidiaries  1. Pending further coordination of consolidation methods, Member States shall provide that, where the parent undertaking of one or more credit institutions  is a mixed-activity holding company, the competent authorities responsible for the authorization and supervision of those credit institutions shall, by approaching the mixed-activity holding company and its subsidiaries either directly or via credit  institution subsidiaries, require them to supply any information which would be relevant for the purposes of supervising the credit institution subsidiaries.  2. Member States shall provide that their competent authorities may carry out, or have carried out by external inspectors, on-the-spot inspections to verify information received from mixed-activity holding companies and their subsidiaries. If the  mixed-activity holding company or one of its subsidiaries is an insurance undertaking, the procedure laid down in Article 7 (4) may also be used. If a mixed-activity holding company or one of its subsidiaries is situated in a Member State other than  that in which the credit institution subsidiary is situated, on-the-spot verification of information shall be carried out in accordance with the procedure laid down in Article 7 (7).  Article 7  Measures to facilitate the application of this Directive  1. Member States shall take the necessary steps to ensure that there are no legal impediments preventing the undertakings included within the scope of supervision on a consolidated  basis, mixed-activity holding companies and their subsidiaries, or subsidiaries of the kind covered in Article 3 (10), from exchanging amongst themselves any information which would be relevant for the purposes of supervision in accordance with this  Directive.  2. Where a parent undertaking and any of its subsidiaries that are credit institutions are situated in different Member States, the competent authorities of each Member State shall communicate to each other all relevant information which may allow or  aid the exercise of supervision on a consolidated basis.  Where the competent authorities of the Member State in which a parent undertaking is situated do not themselves exercise supervision on a consolidated basis pursuant to Article 4, they may be invited by the competent authorities responsible for  exercising such supervision to ask the parent undertaking for any information which would be relevant for the purposes of supervision on a consolidated basis and to transmit it to these authorities.  3. Member States shall authorize the exchange between their competent authorities of the information referred to in paragraph 2, on the understanding that, in the case of financial holding companies, financial institutions or ancillary banking services  undertakings, the collection or possession of information shall not in any way imply that the competent authorities are required to play a supervisory role in relation to those institutions or undertakings standing alone.  Similarly, Member States shall authorize their competent authorities to exchange the information referred to in Article 6 on the understanding that the collection or possession of information does not in any way imply that the competent authorities play  a supervisory role in relation to the mixed-activity holding company and those of its subsidiaries which are not credit institutions, or to subsidiaries of the kind covered in Article 3 (10).  4. Where a credit institution, financial holding company or a mixed-activity holding company controls one or more subsidiaries which are insurance companies or other undertakings providing investment services which are subject to authorization, the  competent authorities and the authorities entrusted with the public task of supervising insurance undertakings or those other undertakings providing investment services shall cooperate closely. Without prejudice to their respective responsibilities,  those authorities shall provide one another with any information likely to simplify their task and to allow supervision of the activity and overall financial situation of the undertakings they supervise.  5. Information received pursuant to this Directive and in particular any exchange of information between competent authorities which is provided for in this Directive shall be subject to the obligation of professional secrecy defined in Article 12 of  Directive 77/780/EEC.  6. The competent authorities responsible for supervision on a consolidated basis shall establish lists of the financial holding companies referred to in Article 3 (2). Those lists shall be communicated to the competent authorities of the other Member  States and to the Commission.  7. Where, in applying this Directive, the competent authorities of one Member State wish in specific cases to verify the information concerning a credit institution, a financial holding company, a financial institution, an ancillary banking services  undertaking, a mixed-activity holding company, a subsidiary of the kind covered in Article 6 or a subsidiary of the kind covered in Article 3 (10), situated in another Member State, they must ask the competent authorities of that other Member State to  have that verification carried out. The authorities which receive such a request must, within the framework of their competence, act upon it either by carrying out the verification themselves, by allowing the authorities who made the request to carry it  out, or by allowing an auditor or expert to carry it out.  8. Without prejudice to their provisions of criminal law, Member States shall ensure that penalties or measures aimed at ending observed breaches or the causes of such breaches may be imposed on financial holding companies and mixed-activity holding  companies, or their effective managers, that infringe laws, regulations or administrative provisions enacted to implement this Directive. In certain cases, such measures may require the intervention of the courts. The competent authorities shall  cooperate closely to ensure that the abovementioned penalties or measures produce the desired results, especially when the central administration or main establishment of a financial holding company or of a mixed-activity holding company is not located  at its head office.  Article 8  Third countries  1. The Commission may submit proposals to the Council, either at the request of a Member State or on its own initiative, for the negotiation of agreements with one or more third countries regarding the means of exercising  supervision on a consolidated basis over:  - credit institutions the parent undertakings of which have their head offices situated in a third country, and  - credit institutions situated in third countries the parent undertakings of which, whether credit institutions or financial holding companies, have their head offices in the Community.  2. The agreements referred to in paragraph 1 shall in particular seek to ensure both:  - that the competent authorities of the Member States are able to obtain the information necessary for the supervision, on the basis of their consolidated financial situations, of credit institutions or financial holding companies situated in the  Community and which have as subsidiaries credit institutions or financial institutions situated outside the Community, or which hold participations in such institutions,  - that the competent authorities of third countries are able to obtain the information necessary for the supervision of parent undertakings the head offices of which are situated within their territories and which have as subsidiaries credit  institutions or financial institutions situated in one or more Member States, or which hold participations in such institutions.  3. The Commission and the Advisory Committee set up under Article 11 of Directive 77/780/EEC shall examine the outcome of the negotiations referred to in paragraph 1 and the resulting situation.  Article 9  Final provisions  1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1993. They shall forthwith inform the Commission thereof.  When Member States adopt the abovementioned measures, the measures shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down  by the Member States.  2. Notwithstanding the provisions of Article 3 (5) and until the future Directive on capital adequacy to cover market risks is brought into effect, the competent authorities shall include in consolidated supervision financial institutions which are  principally exposed to market risks in accordance with methods to be determined by those authorities in the light of the particular nature of the risks involved.  3. Member States shall communicate to the Commission the texts of the main provisions of internal law which they adopt in the field governed by this Directive.  Article 10  1. Directive 83/350/EEC is hereby repealed with effect from 1 January 1993.  2. In the following provisions, the words 'Directive 83/350/EEC' shall be replaced by 'Directive 92/350/EEC':  - Article 5 of Directive 89/299/EEC,  - Articles 12 (5), 13 (3) and 15 (2) and the fifth indent of the first subparagraph of Article 18 (2) of Directive 89/646/EEC,  - Article 3 (3) of Directive 89/647/EEC.  3. In Article 1, point 5, of Directive 89/646/EEC and the first indent of Article 2 (1) of Directive 89/647/EEC, the definition of competent authorities shall be replaced by the following:  'the national authorities which are empowered by law or regulation to supervise credit institutions'.  Article 11  This Directive is addressed to the Member States. Done at Luxembourg, 6 April 1992. For the Council  The President  Joao PINHEIRO   (1) OJ No C 326, 16. 12. 1991, p. 106, and OJ No C 94, 13. 4. 1992. (2) OJ No C 102, 18. 4. 1991, p. 19. (3) OJ No L 193, 18. 7. 1983, p. 18. (4) OJ No L 322, 17. 12. 1977, p. 30. Directive as last amended by Directive 89/646/EEC (OJ No L 386,  30. 12. 1989, p. 1). (5) OJ No L 386, 30. 12. 1989, p. 1. (6) OJ No L 372, 31. 12. 1986, p. 1. (7) OJ No L 193, 18. 7. 1983, p. 1. Directive as last amended by Directive 90/605/EEC (OJ No L 317, 16. 11. 1990, p. 60). (8) OJ No L 124, 5. 5. 1989, p. 16.


title: Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products (Text with EEA relevance)

text:
               30.6.2009

               EN

               Official Journal of the European Union

               L 168/33

      DIRECTIVE 2009/53/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 18 June 2009
   amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products
   (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 95 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (3), 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 (4) and Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (5), lay down harmonised rules for the authorisation, supervision and pharmacovigilance of medicinal products within the Community.

               (2)

               Under those rules, marketing authorisations may be granted in accordance with harmonised Community procedures. The terms of those marketing authorisations may subsequently be varied where, for instance, the production process or the address of the manufacturer has changed.

               (3)

               Article 39 of Directive 2001/82/EC and Article 35 of Directive 2001/83/EC empower the Commission to adopt an implementing regulation as regards variations subsequently made to marketing authorisations granted in accordance with the provisions of Chapter 4 of Title III of Directive 2001/82/EC and Chapter 4 of Title III of Directive 2001/83/EC, respectively. The Commission therefore adopted Regulation (EC) No 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State (6).

               (4)

               However, the majority of medicinal products for human or veterinary use currently on the market have been authorised under purely national procedures and, as such, fall outside the scope of Regulation (EC) No 1084/2003. Variations to marketing authorisations granted under purely national procedures are thus subject to national rules.

               (5)

               Consequently, while the granting of all marketing authorisations for medicinal products is subject to harmonised rules within the Community, this is not the case for variations to the terms of marketing authorisations.

               (6)

               For reasons of public health and legal consistency, and with a view to reducing the administrative burden and strengthening predictability for economic operators, variations to all types of marketing authorisations should be subject to harmonised rules.

               (7)

               The rules on variations adopted by the Commission should pay particular attention to simplifying administrative procedures. To this effect, the Commission should provide, when adopting these rules, for the possibility of submitting a single application for one or more identical changes made to the terms of a number of marketing authorisations.

               (8)

               In accordance with point 34 of the Interinstitutional Agreement on better law-making (7), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

               (9)

               Directive 2001/82/EC and Directive 2001/83/EC should therefore be amended accordingly,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Amendments to Directive 2001/82/EC
   Directive 2001/82/EC is hereby amended as follows:

               1.

               the following Article shall be inserted:
               ‘Article 27b
               The Commission shall adopt appropriate arrangements for the examination of variations to the terms of marketing authorisations granted in accordance with this Directive.
               The Commission shall adopt these arrangements in the form of an implementing regulation. That measure, designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).’

               2.

               the second and third subparagraphs of Article 39(1) shall be deleted.

         Article 2
   Amendments to Directive 2001/83/EC
   Directive 2001/83/EC is hereby amended as follows:

               1.

               the following Article shall be inserted:
               ‘Article 23b
               1.   The Commission shall adopt appropriate arrangements for the examination of variations to the terms of marketing authorisations granted in accordance with this Directive.
               2.   The Commission shall adopt the arrangements referred to in paragraph 1 in the form of an implementing regulation. That measure, designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 121(2a).
               3.   When adopting the arrangements referred to in paragraph 1, the Commission shall make efforts to make it possible to submit a single application for one or more identical changes made to the terms of a number of marketing authorisations.
               4.   A Member State may continue to apply national provisions on variations applicable at the time of entry into force of the implementing regulation to marketing authorisations granted before 1 January 1998 to medicinal products authorised only in that Member State. Where a medicinal product subject to national provisions in accordance with this Article is subsequently granted a marketing authorisation in another Member State, the implementing regulation shall apply to that medicinal product from that date.
               5.   Where a Member State decides to continue to apply national provisions pursuant to paragraph 4, it shall notify the Commission thereof. If a notification has not been made by 20 January 2011, the implementing regulation shall apply.’

               2.

               the second and third subparagraphs of Article 35(1) shall be deleted.

         Article 3
   Transposition
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 20 January 2011 at the latest. They shall forthwith communicate to the Commission the text thereof.
   When Member States adopt those measures, 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.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 4
   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 5
   Addressees
   This Directive is addressed to the Member States.

      Done at Brussels, 18 June 2009.

            For the European Parliament

            The President

         H.-G. PÖTTERING

            For the Council

            The President

         Š. FÜLE

      (1)  OJ C 27, 3.2.2009, p. 39.

      (2)  Opinion of the European Parliament of 22 October 2008 (not yet published in the Official Journal) and Council Decision of 28 May 2009.

      (3)  OJ L 311, 28.11.2001, p. 1.

      (4)  OJ L 311, 28.11.2001, p. 67.

      (5)  OJ L 136, 30.4.2004, p. 1.

      (6)  OJ L 159, 27.6.2003, p. 1.

      (7)  OJ C 321, 31.12.2003, p. 1.