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31982L0621

Commission Directive 82/621/EEC of 1 July 1982 adapting to technical progress Council Directive 76/891/EEC on the approximation of the laws of the Member States relating to electrical energy meters

Official Journal L 252 , 27/08/1982 P. 0001 - 0001 Finnish special edition: Chapter 13 Volume 12 P. 0106  Spanish special edition: Chapter 13 Volume 12 P. 0249  Swedish special edition: Chapter 13 Volume 12 P. 0106  Portuguese special edition Chapter 13 Volume 12 P. 0249

COMMISSION DIRECTIVE of 1 July 1982 adapting to technical progress Council Directive 76/891/EEC on the approximation of the laws of the Member States relating to electrical energy meters (82/621/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 76/891/EEC of 4 November 1976 on the approximation of the laws of the Member States relating to electrical energy meters (1), and in particular the third paragraph of Article 3 thereof,  Whereas, pursuant to Article 3 of Directive 76/891/EEC, it is necessary to review the maximum permissible errors in electrical energy meters for the EEC initial verification in order to take account of experience gained and of results obtained at international level;  Whereas experience gained in this sector within the Community suggests the definitive retention of the tolerances in respect of maximum permissible errors already set out by way of general rate in the Annex to the said Directives which are more stringent than those adopted at international level;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for the Elimination of Technical Barriers to Trade in Measuring Instruments,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Member States which availed themselves of the option provided in the second paragraph of Article 3 of Directive 76/891/EEC shall, before 1 January 1983, repeal the measures adopted by virtue of that option.  They shall forthwith inform the Commission thereof.   Article 2 This Directive is addressed to the Member States.     Done at Brussels, 1 July 1982.  For the Commission  Karl-Heinz NARJES  Member of the Commission  (1) OJ No L 336, 4.12.1976, p. 30.


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31991L0673

Council Directive 91/673/EEC of 19 December 1991 amending Directive 69/179/EEC to extend and modify the exceptions granted to Denmark and to Ireland relating to travellers' allowances

Official Journal L 373 , 31/12/1991 P. 0033 - 0033 Finnish special edition: Chapter 9 Volume 2 P. 0031  Swedish special edition: Chapter 9 Volume 2 P. 0031

COUNCIL DIRECTIVE of 19 December 1991 amending Directive 69/169/EEC to extend and modify  the exceptions granted to Denmark and to Ireland relating to travellers' allowances (91/673/EEC)THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article  99 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament (1), Having regard to the opinion of the Economic and Social Committee (2), Whereas, until 31 December 1991, the Kingdom of Denmark and Ireland qualify for exceptions from  Directive 69/169/EEC (3), as last amended by Directive 91/191/EEC (4), in respect of the  application of the general levels of allowances; Whereas the said exceptions must be seen in the context of Article 8a of the Treaty, which defines  the internal market as an area without internal frontiers in which the free movement of goods,  persons, services and capital is ensured and states that this market should be progressively  established over a period expiring on 31 December 1992; Whereas immediate cessation of the said exceptions might result in economic difficulties for the  Kingdom of Denmark and for Ireland; whereas their application should therefore be extended, in a  modified form in Ireland's case, until 31 December 1992, HAS ADOPTED THIS DIRECTIVE: Article 1 Directive 69/169/EEC is hereby amended as follows: 1. in Article 7b (1) (b), 'ECU 95` shall be replaced by 'ECU 150`; 2. in Article 7c, '31 December 1991` shall be replaced by '31 December 1992`; 3. Article 7d shall be replaced by the following: 'Article 7d Notwithstanding Article 2 (1) and within the limit set out therein, Ireland shall be authorized to  apply a quantitative limit of 30 litres of beer for all travellers to Ireland until 31 December  1992. Notwithstanding Articles 2 (1), 4 (1) and 7b (1) (b), Ireland shall be authorized to apply the  following limits until 31 December 1992 for the import of the goods in question by travellers from  Ireland, after a stay of less than 24 hours outside Ireland: (a) for travellers from the Community: ECU 175, but the unit value may not exceed ECU 110; (b) for beer, 15 litres.` Article 2 1.  Member States shall bring into force the laws, regulations and administrative  provisions necessary to comply with this Directive before 1 January 1992. When Member States adopt the measures referred to in the first subparagraph, 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 a reference shall be laid down by the Member  States. 2.  Member States shall inform the Commission of the text of the main provisions of domestic law  which they adopt in the field covered by this Directive. Article 3 This Directive is addressed to the Member States. Done at Brussels, 19 December 1991. For the CouncilThe PresidentP. DANKERT   (1)Opinion delivered on 10 December 1991 (not yet published in the Official  Journal).  (2)Opinion delivered on 17 December 1991 (not yet published in the Official Journal).  (3)OJ N° L 133, 4. 6. 1969, p. 6.  (4)OJ N° L 94, 16. 4. 1991, p. 24.


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31988L0609

Council Directive 88/609/EEC of 24 November 1988 on the limitation of emissions of certain pollutants into the air from large combustion plants

Official Journal L 336 , 07/12/1988 P. 0001 - 0013 Finnish special edition: Chapter 15 Volume 9 P. 0027  Swedish special edition: Chapter 15 Volume 9 P. 0027

COUNCIL DIRECTIVE of 24 November 1988 on the limitation of emissions of certain pollutants into the air from large combustion plants (88/609/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 130 s thereof,  Having regard to the proposals from the Commission(1),  Having regard to the opinions of the European Parliament(2),  Having regard to the opinion of the Economic and Social Committee(3),  Whereas the 1973(4), 1977(5), 1983(6) and 1987(7) European Communities action programmes on the environment stress the importance of the reduction and prevention of atmospheric pollution;  Whereas in their resolution concerning the action programme on the environment 1987 to 1992, the Council and the Representatives of Governments of the Member States meeting within the Council emphasize the importance for Community action to concentrate as a priority on the reduction at source of air pollution, inter alia by adopting and implementing  measures concerning emissions from large combustion plants;  Whereas, moreover, under Decision 81/462/EEC(8), the Community became a Party to the Convention on long-range transboundary air pollution;  Whereas Council Directive 84/360/EEC of 28 June 1984 on the combating of air pollution from industrial plants(9) provides for the introduction of certain procedures and measures aiming to prevent or reduce air pollution from industrial plants,  particularly those belonging to listed categories, among which are large combustion plants;  Whereas Article 8 of the same Directive 84/360/EEC stipulates that the Council, acting unanimously on a proposal from the Commission shall, if necessary, fix emission limit values for new plants based on the best available technology not entailing  excessive costs and taking into account the nature, quantities and harmfulness of the emissions concerned; whereas Article 13 thereof stipulates that Member States shall implement policies and strategies, including appropriate measures, for the gradual  adaptation of existing plants belonging to listed categories to the best available technology and taking various specified matters into account;  Whereas the damage to the environment owing to air pollution makes it urgent to reduce and control emissions from new and existing large combustion plants and whereas to this end it is necessary to set overall objectives for a gradual and staged  reduction of total annual emissions of sulphur dioxide and oxides of nitrogen from existing combustion plants and to fix emission limit values for sulphur dioxide, nitrogen oxides and dust in case of new plants, in accordance with the principle set out  in Article 8 of the Diretive 84/360/EEC;  Whereas such emission limit values for new plants will need to be reviewed in the light of technological developments and the evolution of environmental requirements, and the Commission will submit proposals to this effect;  Whereas in establishing the overall annual emission ceilings for existing large combustion plants due account has been taken of the need for comparable effort, whilst making allowance for the specific situations of Member States; whereas, in  establishing the requirements for the reduction of emissions from new plants, due account has been taken of particular technical and economic constraints in order to avoid excessive costs; whereas in the case of Spain there has been granted a temporary  and limited derogation from the full application of the emission limit value of sulphur dioxide fixed for new plants, since that Member State considers it needs a particularly high amount of new generating capacity to allow for its energy and industrial  growth,   HAS ADOPTED THIS DIRECTIVE:  Article 1  This Directive shall apply to combustion plants, the rated thermal input of which is equal to or greater than 50 MW, irrespective of the type of fuel used (solid, liquid or gaseous).  Article 2  For the purpose of this Directive:   1.´emission' means: the discharge of substances from the combustion plant into the air;   2.´waste gases' means: gaseous discharges containing solid, liquid or gaseous emissions; their volumetric flow rates shall be expressed in cubic metres per hour at standard temperature (273 K) and pressure (101,3 kPa) after correction for the water  vapour content, hereinafter referred to as (Nm³h);   3.´emission limit value' means: the permissible quantity of a substance contained in the waste gases from the combustion plant which may be discharged into the air during a given period; it shall be calculated in terms of mass per volume of the waste gases expressed in mg/Nm³, assuming an oxygen content by volume in the waste gas of 3 % in the case of liquid and gaseous fuels and 6 % in the case of solid fuels;   4.´rate of desulphurization' means: the ratio of the quantity of sulphur which is separated out at the combustion plant site over a given period by processes especially designed for this purpose, to the quantity of sulphur contained in the fuel which  is introduced into the combustion plant facilities and which is used over the same period;   5.´operator' means: any natural or legal person who operates the combustion plant, or who has or has been delegated decisive economic power over it;   6.´fuel' means: any solid, liquid or gaseous combustible material used to fire the combustion plant, with the exception of domestic refuse and toxic or dangerous waste;   7.´combustion plant' means: any technical appartus in which fuels are oxidized in order to use the heat thus generated.  This Directive shall apply only to combustion plants designed for production of energy with the exception of those which make direct use of the products of combustion in manufacturing processes.  In particular, this Directive shall not apply to the following plants:  -plants in which the products of combustion are used for the direct heating, drying, or any other treatment of objects or materials e.g. reheating furnaces, furnaces for heat treatment.  -post-combustion plants i.e. any technical apparatus designed to purify the waste gases by combustion which is not operated as an independent combustion plant,  -facilities for the regeneration of catalytic cracking catalysts,  -facilities for the conversion of hydrogen sulphide into sulphur,  -reactors used in the chemical industry,  -coke battery furnaces,  -cowpers.  Plants powered by diesel, petrol and gas engines or by gas turbines, irrespective of the fuel used, shall not be covered by this Directive.  Where two or more separate new plants are installed in such a way that, taking technical and economic factors into account, their waste gases could, in the judgment of the competent authorities, be discharged through a common stack, the combination  formed by such plants is to be regarded as a single unit.   8.´multi-fuel firing unit' means: any combustion plant which may be fired simultaneously or alternately by two or more types of fuel;   9.´new plant' menas: any combustion plant for which the original construction licence or, in the absence of such a procedure, the original operating licence was granted on or after 1 July 1987;  10.´existing plant' means: any combustion plant for which the original construction licence or, in the absence of such a procedure, the original operating licence was granted before 1 July 1987.  Article 3  1.  Not later than 1 July 1990, the Member States shall draw up appropriate programmes for the progressive reduction of total annual emissions from existing plants. The programmes shall set out the timetables and the implementing procedures.  2.  The programmes shall be drawn up and implemented with the aim of complying, through the appropriate limitation of emissions, at least with the emission ceilings and with the corresponding percentage reductions laid down for sulphur dioxide in Annex  I, columns 1 to 6 and for oxides of nitrogen in Annex II, columns 1 to 4 by the dates specified in those Annexes.  3.  When the programmes are being carried out, Member States shall also determine the total annual emissions in accordance with Annex IX, point C.  4.  In 1994 the Commission, on the basis of the summary reports provided by the Member States pursuant to Article 16, shall make a report to the Council on the implementation of the reductions referred to in this Article, accompanied where necessary by proposals for a revision of the phase 3 reduction targets and/or date for sulphur dioxide and the phase 2  reduction targets and/or date for oxides of nitrogen. The Council shall decide upon such proposals by unanimity.  5.  If a substantial and unexpected change in energy demand or in the availability of certain fuels or certain generating installations creates serious technical difficulties for the implementation by a Member State of its programme drawn up under  paragraph 1, the Commission at the request of the Member State concerned, and taking into account the terms of the request, shall take a decision to modify, for that Member State, the emission ceilings and/or the dates set out in Annexes I and II and  communicate its decision to the Council and to the Member States.  Any Member State may within three months refer the decision of the Commission to the Council. The Council, acting by a qualified majority, may within three months take a different decision.  Article 4  1.  Member States shall take appropriate measures to ensure that all licences for the construction or, in the absence of such a procedure, for the operation of new plants contain conditions relating to compliance with the emission limit  values fixed in Annexes III to VII in respect of sulphur dioxide, oxides of nitrogen and dust.  2.  Before 1 July 1995, and in the light of the state of technology and environmental requirements, the Commission shall submit proposals for the revision of the limit values applicable. The Council shall decide upon such proposals by unanimity.  3.  Member States may require compliance with emission limit values and time limits for implementation which are more stringent than those set out in paragraphs 1 and 2; they may include other pollutants, and they may impose additional requirements or  adaptation of plant to technical progress.  Article 5  By way of derogation from Annex III:  1.New plants, of a rated thermal input equal to or greater than 400 MW, which do not operate more than 2 200 hours a year (rolling average over a period of five years), shall be subject to a limit value for sulphur dioxide emissions of 800 mg/Nm³.  2.New plants which burn indigenous solid fuel, where the emission limit value set for sulphur dioxide for such plants cannot be met, owing to the particular nature of the fuel, without using excessively expensive technology, may exceed the limit values  laid down in Annex III.  Such plants shall at least achieve the rates of desulphurization laid down in Annex VIII.  3.Until 31 December 1999, the Kingdom of Spain may authorize new power plants with a rated thermal input equal to or greater than 500 MW burning indigenous or imported solid fuels, commissioned before the end of 2005 and complying with the following  requirements:  -in the case of imported solid fuels, a sulphur dioxide emission limit value of 800 mg/Nm³,  -in the case of indigenous solid fuels, at least a 60 % rate of desulphurization,  provided that the total authorized capacity of such plants to which this derogation applies does not exceed:  -2 000 MWe in the case of plants burning indigenous solid fuels,  -in the case of plants burning imported solid fuels either 7 500 MWe or 50 % of all the new capacity of all plants burning solid fuels authorized up to 31 December 1999, whichever is the lower.  Article 6  Member States may authorize plants burning indigenous lignite to exceed the emission limit values fixed in accordance with Article 4 if, notwithstanding the application of best available technology not entailing excessive costs, major  difficulties connected with the nature of the lignite so require and provided that lignite is an essential source of fuel for the plants.  The Commission shall immediately be informed of such cases, which shall be the subject of consultation with the Commission on the appropriate measures to be taken.  Article 7  In order to ensure compliance with the emission limit values for oxides of nitrogen in Annex VI, the licences referred to in Article 4 (1) may require, inter alia, appropriate design specifications.  In the event that monitoring reveals that due to unforeseen reasons, the emission limit value is not being complied with, the competent authority shall require the operator to take all appropriate primary measures to achieve compliance as soon as  possible and in any case within one year. The Commission shall immediately be informed of such cases and of the results of the remedial measures taken.  The provisions of this Article shall be reviewed on the basis of a proposal from the Commission to be submitted to the Council at the same time as the proposals referred to in Article 4 (2).  Article 8  1.  Member States shall ensure that provision is made in the licences referred to in Article 4 (1) for procedures relating to malfunction or breakdown of the abatement equipment. In case of a breakdown the competent authority shall be  notified without delay and shall decide upon the appropriate action. The competent authority shall in particular require the operator to reduce or close down operations as soon as practicable and until normal operations can be restored, or to operate  the plant using low polluting fuels, except in cases where, in the judgement of the competent authority, there is an overriding need to maintain electricity supplies. It shall in particular ensure that the operator takes all the necessary steps to  recommission the abatement equipment as soon as possible.  2.  The competent authority may allow a suspension for a maximum of six months from the obligation to comply with the emission limit values provided for in Article 4 for sulphur dioxide in respect of a plant which to this end normally uses low-sulphur  fuel, in cases where the operator is unable to comply with these limit values because of an interruption in the supply of low-sulphur fuel resulting from a serious shortage.  3.  The competent authority may allow a derogation from the obligation to comply with the emission limit values provided for in Article 4 in cases where a plant which normally uses only gaseous fuel, and which would otherwise need to be equipped with a  waste gas purification facility, has to resort exceptionally, and for a short period, to the use of other fuels because of a sudden interruption in the supply of gas. The competent autority shall immediately be informed of each specific case as it  arises.  4.  Member States shall inform the Commission immediately of the cases referred to in this Article.  Article 9  1.  For the purpose of granting the licence referred to in Article 4 (1) for a new plant with a multi-fuel firing unit involving the simultaneous use of two or more fuels, the competent authorities shall set the emission limit values as  follows:  -firstly by taking the emission limit value relevant for each individual fuel and pollutant corresponding to the rated thermal input of the combustion plant as given in Annexes III to VII,  -secondly by determining fuel-weighted emission limit values, which are obtained by multiplying the above individual emission limit value by the thermal input delivered by each fuel, the product of multiplication being divided by the sum of the thermal  inputs delivered by all fuels,  -thirdly by aggregating the fuel-weighted limit values.  2.  In multi-firing units using the distillation and conversion residues from crude-oil refining for own consumption, alone or with other fuels, the provisions for the fuel with the highest emission limit value (determinative fuel) shall apply,  notwithstanding paragraph 1 above, if during the operation of the combustion plant the proportion contributed by that fuel to the sum of the thermal inputs delivered by all fuels is at least 50 %.  Where the proportion of the determinative fuel is lower than 50 %, the emission limit value is determined on a pro rata basis of the heat input supplied by the individual fuels in relation to the sum of the thermal inputs delivered by all fuels as follows:  -firstly by taking the emission limit value relevant for each individual fuel and pollutant corresponding to the rated heat input of the combustion plant as given in Annexes III to VII,  -secondly by calculating the emission limit value of the determinative fuel (fuel with the highest emission limit value according to Annexes III to VII and, in the case of two fuels having the same emission limit value, the fuel with the higher thermal  input); this value is obtained by multiplying the emission limit value laid down in Annexes III to VII for that fuel by a factor of two, and subracting from this product the emission limit value of the fuel with the lowest emission limit value,  -thirdly by determining the fuel-weighted emission limit values, which are obtained by multiplying the calculated fuel emission limit value by the thermal input of the determinative fuel and the other individual emission limit values by the thermal  input delivered by each fuel, the product of multiplication being divided by the sum of the thermal inputs delivered by all fuels,  -fourthly by aggregating the fuel-weighted emission limit values.  3.  As an alternative to paragraph 2, an emission limit value for sulphur dioxide of 1 000 mg/Nm³ can be applied, averaged over all new plants of the refinery and irrespective of the fuel combinations used.  The competent authorities shall ensure that the application of this provision does not lead to an increase in emissions from existing plants.  4.  For the purpose of granting the licence referred to in Article 4 (1) for a new plant with a multi-fuel firing unit involving the alternate use of two or more fuels, the emission limit values set in Annexes III to VII corresponding to each fuel used  shall apply.  Article 10  Waste gases from combustion plants shall be discharged in controlled fashion by means of a stack.  The licence referred to in Article 4 (1) shall lay down the discharge conditions. The competent authority shall in particular ensure that the stack height is calculated in such a way as to safeguard health and the environment.  Article 11  Where a combustion plant is extended by at least 50 MW, the emission limit value to be applied to the new part of the plant shall be fixed in relation to the thermal capacity of the entire plant. This provision shall not apply in the cases  referred to in Article 9 (2) and (3).  Article 12  In the case of construction of combustion plants which are likely to have significant effects on the environment in another Member State, the Member States shall ensure that all appropriate information and consultation takes place, in  accordance with Article 7 of Council Directive 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment.(10) Article 13  1.  Member States shall take the necessary measures to ensure the monitoring, in accordance with Annex IX, of emissions from the combustion plants covered by this Directive and of all other values required for the implementation of this  Directive. Member States may require that such monitoring shall be carried out at the operator's expense.  2.  The measuring methods and/or equipment used in order to determine the concentrations of sulphur dioxide, dust, oxides of nitrogen and oxygen and the other values required in order to monitor implementation of this Directive, and all other equipment  used in order to evaluate the results, shall correspond to the best industrial measurement technology and shall provide reproducible and comparable results.  The determination methods must be approved by the competent authorities.  3.  The competent authorities shall make available information relating to the performance criteria for measuring, calibration and data-handling equipment or methods used to this end and shall forward this information to the Commission.  Article 14  The Member States shall take appropriate measures to ensure that the operator informs the competent authorities within reasonable time limits about the results of the continuous measurements, the checking of the measuring equipment, and the  individual measurements and about all other measurements carried out in order to assess compliance with this Directive.  Article 15  1.  In the event of continuous measurements, the emission limit values set out in Annexes III to VII shall be regarded as having been complied with if the evaluation of the results indicates, for operating hours within a calendar year,  that:  a)none of the calendar monthly mean values exceeds the emission limit values; and b)in the case of:  -sulphur dioxide and dust: 97 % of all the 48 hourly mean values do not exceed 110 % of the emission limit values,  -oxides of nitrogen: 95 % of all the 48 hourly mean values do not exceed 110 % of the emission limit values.  The periods referred to in Article 8 as well as start up and shut down periods shall be disregarded.  2.  In cases where only discontinuous measurements or other appropriate procedures for determination are required, the emission limit values set out in Annexes III to VII shall be regarded as having been complied with if the results of each of the  series of measurements or of the other procedures defined and determined according to the rules laid down by the competent authorities do not exceed the emission limit values.  3.  In the cases referred to in Article 5 (2) and (3), the rates of desulphurization shall be regarded as having been complied with if the evalutation of measurements carried out pursuant to Annex IX, point A.2, indicates that all of the calendar  monthly mean values or all of the rolling monthly mean values achieve the required desulphurization rates.  The periods referred to in Article 8 as well as start up and shut down periods shall be disregarded.  Article 16  1.  Member States shall, not later than 31 December 1990, inform the Commission of the programmes drawn up in accordance with Article 3 (1).  At the latest one year after the end of the different phases for reduction of emissions from existing plants the Member States shall forward to the Commission a summary report on the results of the implementation of the programmes.  An intermediate report is required as well in the middle of each phase.  2.  The reports referred to in paragraph 1 shall provide an overall view:  -of all the combustion plants covered by this Directive,  -of emissions of sulphur dioxide, and oxides of nitrogen expressed in tonnes per annum and as concentrations of these substances in the waste gases,  -of measures already taken or envisaged with a view to reducing emissions, and of changes in the choice of fuel used,  -of changes in the method of operation already made or envisaged,  -of definitive closures of combustion plants already effected or envisaged,  -and, where appropriate, of the emission limit values imposed in the programmes in respect of existing plants.  When determining the annual emissions and concentrations of pollutants in the waste gases, Member States shall take account of the provisions of Articles 13, 14 and 15.  3.  The Commission shall organize regular comparisons of the programmes referred to in Article 3 (1) with the Member States in order to ensure harmonized implementation of the programmes at Community level.  The Commission shall take particular care to ensure that the implementation of the programmes produces the expected results in terms of the overall reduction in emissions and shall, if necessary, make appropriate proposals.  .  Member States applying Article 5 will report thereon annually to the Commission.  Article 17  1.  Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive no later than 30 June 1990. They shall forthwith inform the Commission thereof.  2.  Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.  Article 18  This Directive is addressed to the Member States.   Done at Brussels, 24 November 1988.  For the CouncilThe PresidentV. KEDIKOGLOU  (1)OJ No C 49, 21. 2. 1984, p. 1 and OJ No C 76, 22. 3. 1985, p. 6.  (2)OJ No C 337, 17. 12. 1984, p. 446 and OJ No C 175, 15. 7. 1985, p. 297.  (3)OJ No C 25, 28. 1. 1985, p. 3.  (4)OJ No C 112, 20. 12. 1973, p. 1.  (5)OJ No C 139, 13. 6. 1977, p. 1.  (6)OJ No C 46, 17. 2. 1983, p. 1.  (7)OJ No C 328, 7. 12. 1987, p. 1.  (8)OJ No L 171, 27. 6. 1981, p. 11.  (9)OJ No L 188, 16. 7. 1984, p. 20.  (10)OJ No L 175, 5. 7. 1985, p. 40.    ANNEX IX METHODS OF MEASUREMENT OF EMISSIONS A.Procedures for measuring and evaluating emissions from new plants 1.Concentrations of SO2, dust, NOx and oxygen shall be measured continuously in the case of new plants with a rated thermal input of more than 300 MW. However, monitoring of SO2 and dust may be confined to discontinuous measurements or other appropriate  determination procedures in cases where such measurements or procedures, which must be verified and approved by the competent authorities, may be used to obtain concentration.  In the case of plants not covered by the first subparagraph, the competent authorities may require continuous measurements of those three pollutants and of oxygen to be carried out where considered necessary. Where continuous measurements are not  required, discontinuous measurements or appropriate determination procedures as approved by the competent authorities shall be used regularly to evaluate the quantity of the abovementioned substances present in the emissions.  2.In the case of plants which must comply with the desulphurization rates fixed by Article 5 (2) and (3), the requirements concerning SO2 emission measurements established under paragraph 1 shall apply. Moreover, the sulphur content of the fuel which is  introduced into the combustion plant facilities must be regularly monitored.  3.The competent authorities shall be informed of substantial changes in the type of fuel used or in the mode of operation of the plant. They shall decide whether the monitoring requirements laid down in paragraph 1 are still adequate or require  adaptation.  4.Continuously-operating measuring systems shall be checked at regular intervals in consultation with the competent authorities. The instruments for the measurement of concentrations of SO2, dust, NOx and oxygen shall undergo basic calibrationn and an  examination of their operation at appropriate regular intervals. The continuously-operating measuring equipment shall be calibrated in accordance with a reference measuring method approved by the competent authority.  B.Determination of total annual emissions of new plants The competent authorities shall obtain determination of the total annual emissions of SO2 and NOx. When continuous monitoring is used, the operator of the combustion plant shall add up separately for each pollutant the mass of pollutant emitted each  day, on the basis of the volumetric flow rates of waste gases. Where continuous monitoring is not in use, estimates of the total annual emissions shall be determined by the operator on the basis of paragraph A.1 to the satisfaction of the competent  authorities.  Member States shall communicate to the Commission the total annual SO2 and NOx emissions of new combustion plants at the same time as the communication required under paragraph C.3 concerning the total annual emissions of existing plants.  C.Determination of the total annual emissions of existing plants 1.Member States shall establish, starting in 1990 and for each subsequent year, a complete emission inventory for existing plants covering SO2 and NOx:  -on a plant by plant basis for plants above 300 MWth and for refineries;  -on an overall basis for other combustion plants to which this Directive applies.  2.The methodology used for these inventories shall be consistent with that used to determine SO2 and NOx emissions from combustion plants in 1980.  By 1990 Member States shall inform the Commission of full details of methods and base data used for establishing the emissions of SO2 and NOx from existing combustion plants, referred to respectively in Annexes I and II, column 0.  3.The results of this inventory shall be communicated to the Commission in a conveniently aggregated form within nine months from the end of the year considered.  The methodology used for establishing such emission inventories and the detailed base information shall be made available to the Commission at its request.  4.The Commission shall organize a systematic comparison of such national inventories and, if appropriate, shall present proposals to the Council aiming at harmonizing emission inventory methodologies, for the needs of an effective implementation of this  Directive.


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31999L0062

Directive 1999/62/EC of the European Parliament and of the Council of 17 June 1999 on the charging of heavy goods vehicles for the use of certain infrastructures

Official Journal L 187 , 20/07/1999 P. 0042 - 0050

DIRECTIVE 1999/62/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof 17 June 1999on the charging of heavy goods vehicles for the use of certain infrastructuresTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Articles 71(1) and 93 thereof,Having regard to the proposal from the Commission(1),Having regard to the Opinion of the Economic and Social Committee(2),Having regard to the Opinion of the Committee of the Regions(3)Acting in accordance with the procedure laid down in Article 251 of the Treaty(4),Whereas:(1) The elimination of distortions of competition between transport undertakings in the Member States calls for both the harmonisation of levy systems and the establishment of fair mechanisms for charging infrastructure costs to hauliers;(2) These objectives can be achieved only in stages;(3) A degree of harmonisation of levy systems has already been achieved through the adoption of Council Directive 92/81/EEC of 19 October 1992 on the harmonisation of the structures of excise duties on mineral oils(5) and Council Directive 92/82/EEC of 19 October 1992 on the approximation of the rates of excise duties on mineral oils(6);(4) By judgment of 5 July 1995 in Case C-21/94 European Parliament v. Council(7) the Court of Justice of the European Communities annulled Council Directive 93/89/EEC of 25 October 1993 on the application by Member States of taxes on certain vehicles used for the carriage of goods by road and tolls and user charges for the use of certain infrastructures(8), while preserving the effects of that Directive until the Council had adopted a new Directive; therefore, Directive 93/89/EEC is replaced by this Directive;(5) Under present circumstances the adjustment of national levy systems should be confined to commercial vehicles of more than a certain gross laden weight;(6) For this purpose minimum rates should be set for the vehicle taxes currently applied by the Member States or any which might succeed them;(7) The use of road-friendly and less polluting vehicles should be encouraged through differentiation of taxes or charges, provided that such differentiation does not interfere with the functioning of the internal market;(8) It is appropriate that certain Member States may be granted a period of derogation from the minima to facilitate adaptation to the levels required by this Directive;(9) Certain local domestic transport operations with little impact on the Community transport market are at present subject to reduced rates of vehicle tax; in order to ensure smooth transition, Member States should be authorised to lay down temporary derogations from minimum rates;(10) Member States should be permitted to apply reduced rates or exemptions of vehicle taxes in the case of vehicles whose use is not liable to affect the Community transport market;(11) In order to make allowance for certain special situations, a procedure should be laid down whereby Member States may be permitted to maintain further exemptions or reductions;(12) Existing distortions of competition cannot be eliminated solely by harmonising taxes or fuel excise duties; however, until technically and economically more appropriate forms of levy are in place, such distortions may be attenuated by the possibility of retaining or introducing tolls and/or user charges for the use of motorways; in addition Member States should be allowed to levy charges for the use of bridges, tunnels and mountain passes;(13) In view of the specific conditions on certain Alpine routes, it may be appropriate for a Member State to disapply a user charge system from a well defined section of its motorway network in order to permit application of an infrastructure related charge;(14) Tolls and user charges should not be discriminatory nor entail excessive formalities or create obstacles at internal borders; therefore, adequate measures should be taken to permit the payment of tolls and user charges at any time and with different means of payment;(15) The rates of user charges should be based on the duration of the use made of the infrastructure in question and be differentiated in relation to the costs caused by the road vehicles;(16) Reduced rates of user charges should be applied temporarily for vehicles registered in Greece to take account of difficulties due to its geopolitical position;(17) In order to ensure that user charges and tolls are applied homogeneously, certain rules for determining their manner of application should be laid down, such as the characteristics of the infrastructure to which they are applicable, the maximum levels of certain rates and other general conditions that will have to be complied with; weighted average tolls should be related to the costs of construction, operating and developing the infrastructure network concerned;(18) Member States should be able to attribute to environmental protection and the balanced development of transport networks a percentage of the amount of the user charge or of the toll, provided that this amount is calculated in accordance with the provisions of this Directive;(19) The amounts in this Directive expressed in the national currency units of Member States adopting the euro were fixed on 1 January 1999 when the value of the euro was determined in accordance with Council Regulation (EC) No 2866/98 of 31 December 1998 on the conversion rates between the euro and the currencies of the Member States adopting the euro(9); it is appropriate that Member States not adopting the euro should review annually the amounts in this Directive in national currencies and adjust them where appropriate to take account of changes in the exchange rates; annual adjustments in national currencies may not be compulsory if the change resulting from the application of the new exchange rates is below a certain percentage level;(20) The principle of territoriality should be applied; two or more Member States may cooperate for the purpose of introducing a common system of user charges, subject to compliance with some additional conditions;(21) In accordance with the principle of proportionality, this Directive limits itself to the minimum required for the attainment of the objectives under the third paragraph of Article 5 of the Treaty;(22) A strict timetable should be set for reviewing the provisions of this Directive and considering adjustments to them, if necessary, with the aim of developing a more territorial levy system,HAVE ADOPTED THIS DIRECTIVE:CHAPTER IGeneral provisionsArticle 1This Directive applies to vehicle taxes, tolls and user charges imposed on vehicles as defined in Article 2.This Directive shall not affect vehicles carrying out transport operations exclusively in the non-European territories of the Member States.It shall also not affect vehicles registered in the Canary Islands, Ceuta and Melilla, the Azores or Madeira and carrying out transport operations exclusively in those territories or between those territories and, respectively, mainland Spain and mainland Portugal.Article 2For the purposes of this Directive:(a) "motorway" means a road specially designed and built for motor traffic, which does not serve properties bordering on it, and which:(i) is provided, except at special points or temporarily, with separate carriageways for the two directions of traffic, separated from each other either by a dividing strip not intended for traffic or, exceptionally, by other means;(ii) does not cross at grade with any road, railway or tramway track, or footpath;(iii) is specifically designated as a motorway;(b) "toll" means payment of a specified amount for a vehicle travelling the distance between two points on the infrastructures referred to in Article 7(2); the amount shall be based on the distance travelled and the type of the vehicle;(c) "user charge" means payment of a specified amount conferring the right for a vehicle to use for a given period the infrastructures referred to in Article 7(2);(d) "vehicle" means a motor vehicle or articulated vehicle combination intended exclusively for the carriage of goods by road and having a maximum permissible gross laden weight of not less than 12 tonnes;(e) "EURO I vehicle" means a vehicle having the characteristics set out in line A of the table in Section 8.3.1.1 of Annex I to Council Directive 88/77/EEC of 3 December 1987 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous and particulate pollutants from diesel engines for use in vehicles(10);(f) "EURO II vehicle" means a vehicle having the characteristics set out in line B of the table in section 8.3.1.1 of Armex I to Directive 88/77/EEC.CHAPTER IIVehicle taxationArticle 31. The vehicle taxes referred to in Article are as follows:- Belgium:taxe de circulation sur les véhicules automobiles/ /verkeersbelasting op de autovoertuigen,- Denmark:vaegtafgift of motorkeretrajer m.v.,- Germany:Kraftfahrzeugsteuer,- Greece:Τέλη κυκλοφορίας- Spain:(a) impuesto sobre vehiculos de traccion mecanica;(b) impuesto sobre actividades economicas (solely as regards the amount of the levies charged for motor vehicles),- France:(a) taxe spéciale sur certains véhicules routiers;(b) taxe différentielle sur les véhicules a moteur,- Ireland:vehicle excise duty,- Italy:(a) tassa automobilistica;(b) addizionale del 5 % sulfa tassa automobilistica,- Luxembourg:taxe sur les véhicules automoteurs,- Netherlands:motorrijtuigenbelasting,- Austria:Kraftfahrzeugsteuer,- Portugal:(a) imposto de camionagem;(b) imposto de circulaçao,- Finland:varsinainen ajoneuvovero//egentlig fordonsskatt,- Sweden:fordonsskatt,- United Kingdom:(a) vehicle excise duty;(b) motor vehicles licence.2. Member States which replace any tax listed in paragraph l with another tax of the same kind shall notify the Commission, which shall make the necessary amendments.Article 4Procedures for levying and collecting the taxes referred to in Article 3 shall be determined by each Member State.Article 5As regards vehicles registered in the Member States, the taxes referred to in Article 3 shall be charged solely by the Member State of registration.Article 61. Whatever the structure of the taxes referred to in Article 3, Member States shall set the rates so as to ensure that the tax rate for each vehicle category or subcategory referred to in Annex I is not lower than the minimum laid down in that Annex.Until two years after entry into force of the Directive, Greece, Italy, Portugal and Spain shall be authorised to apply rates that are lower than, but not less than, 65 % of the minima laid down in Annex I.2. Member States may apply reduced rates or exemptions for:(a) vehicles used for national or civil defence purposes, by fire and other emergency services and by the police, and vehicles used for road maintenance;(b) vehicles which travel only occasionally on the public roads of the Member State of registration and are used by natural or legal persons whose main occupation is not the carriage of goods, provided that the transport operations carried out by these vehicles do not cause distortions of competition, and subject to the Commission's agreement.3. (a) The Council, acting unanimously on a proposal from the Commission, may authorise a Member State to maintain further exemptions from or reductions in taxes on vehicles on the grounds of specific policies of a socio-economic nature or linked to that State's infrastructure. Such exemptions or reductions may apply only to vehicles registered in that Member State which carry out transport operations exclusively inside a well-defined part of its territory.(b) Any Member State wishing to maintain such an exemption or reduction shall inform the Commission thereof and shall also forward to it all necessary information. The Commission shall inform the other Member States of the proposed exemption or reduction within one month.The Council shall be deemed to have authorised maintenance of the proposed exemption or reduction if, within a period of two months from the date on which the other Member States were informed in accordance with the first subparagraph, neither the Commission nor any Member State has requested that the matter be examined by the Council.4. Without prejudice to the second subparagraph of paragraph l and to paragraphs 2 and 3 of this Article or to Article 6 of Council Directive 92/106/EEC of 7 December 1992 on the establishment of common rules for certain types of combined transport of goods between Member States(11), Member States may not grant any exemption from, or any reduction in, the taxes referred to in Article 3 which would render the chargeable tax lower than the minimum referred to in paragraph l of this Article.CHAPTER IIITolls and user chargesArticle 71. Member States may maintain or introduce tolls and/or user charges under the conditions set out in paragraphs 2 to 10.2. (a) Tolls and user charges shall be imposed only on users of motorways or other mufti-lane roads with characteristics similar to motorways, or users of bridges, tunnels and mountain passes.However, in a Member State where no general network of motorways or dual carriageways with similar characteristics exists, tolls and user charges may be imposed in that State on users of the highest category of road from the technical point of view.(b) Following consultations with the Commission, and in accordance with the procedure laid down in the Council Decision of 21 March 1962 instituting a procedure for prior examination and consultation in respect of certain laws, regulations and administrative provisions concerning transport proposed in Member States(12),(i) tolls and user charges may also be imposed on users of other sections of the primary road network, particularly- where there are safety reasons for doing so,- in a Member State where no coherent network of motorways or dual carriageways with similar characteristics exists in the major part of the State, in that part of the country, but only on roads used for international and interregional heavy goods transport, provided that the traffic demand and population density do not economically justify the construction of motorways or of dual carriageway roads with similar characteristics;(ii) special arrangements for border areas may be made by the Member States concerned;(iii) Austria may exempt from the Austrian user charge the stretch of motorway between Kufstein and Brenner.3. Tolls and user charges may not both be imposed at the same time for the use of a single road section. However, Member States may also impose tolls on networks where user charges are levied for the use of bridges, tunnels, and mountain passes.4. Tolls and user charges may not discriminate, directly or indirectly, on the grounds of the nationality of the haulier or the origin or destination of the vehicle.5. Tolls and user charges shall be applied and collected and their payment monitored in such a way as to cause as little hindrance as possible to the free flow of traffic and avoid any mandatory controls or checks at the Community's internal borders. To this end, Member States shall cooperate in establishing methods for enabling hauliers to pay user charges 24 hours a day, at least at the major sales outlets, using all common means of payment, inside and outside the Member States in which they are applied. Member States shall provide adequate facilities at the points of payment for tolls and user charges so as to maintain normal road-safety standards.6. A Member State may provide that vehicles registered in that Member State shall be subject to user charges for the use of the whole road network in its territory.7. User charges, including administrative costs, for all vehicle categories shall be set by the Member State concerned at a level which is not higher than the maximum rates laid down in Annex II.On 1 July 2002 and every second year thereafter these maximum rates shall be reviewed. When necessary, the Commission shall make proposals for appropriate adjustments and the European Parliament and the Council shall act on them, in accordance with the conditions laid down in the Treaty.Member States applying a user charge shall, until two years after entry into force of this Directive, apply a 5O % reduction in the rates of user charges for vehicles registered in Greece because of its geopolitical position. The Commission may decide to authorise an extension of this reduction by these Member States from year to year.8. User-charge rates shall be in proportion to the duration of the use made of the infrastructure.A Member State may apply only annual rates for vehicles registered in that State.9. The weighted average tolls shall be related to the costs of constructing, operating and developing the infrastructure network concerned.10. Without prejudice to the weighted average tolls referred to in paragraph 9, Member States may vary the rates at which tolls are charged according to:(a) vehicle emission classes, provided that no toll is more than 5O % above the toll charged for equivalent vehicles meeting the strictest emission standards;(b) time of day, provided that no toll is more than 100 % above the toll charged during the cheapest period of the day.Any variation in tolls charged with respect to vehicle emission classes or the time of day shall be proportionate to the objective pursued.Article 81. Two or more Member States may cooperate in introducing a common system for user charges applicable to their territories as a whole. In that case, those Member States shall ensure that the Commission is closely involved therein and in the system's subsequent operation and possible amendment.2. A common system shall be subject to the following conditions in addition to those in Article 7:(a) the common user-charge rates shall be set by the participating Member States at levels that are not higher than the maximum rates referred to in Article 7(7);(b) payment of the common user charge shall give access to the network as defined by the participating Member States in accordance with Article 7(2);(c) other Member States may join the common system;(d) a scale shall be worked out by the participating Member States whereby each of them shall receive a fair share of the revenues accruing from the user charge.CHAPTER IVFinal provisionsArticle 91. This Directive shall not prevent the application by Member States of:(a) specific taxes or charges:- levied upon registration of the vehicle, or- imposed on vehicles or loads of abnormal weights or dimensions;(b) parking fees and specific urban traffic charges;(c) regulatory charges specifically designed to combat time and place-related traffic congestion.2. Neither shall this Directive prevent the Member States from attributing to environmental protection and the balanced development of transport networks a percentage of the amount of the user charge, or of the toll, provided that this amount is calculated in accordance with Article 7(7) and (9).Article 101. For the purpose of this Directive, the rates of exchange between the euro and the national currencies of the Member States which have not adopted the euro shall be those in force on the first working day of October and published in the Official Journal of the European Communities; they shall have effect from 1 January of the following calendar year.2. Member States which have not adopted the euro may maintain the amounts in force at the time of the annual adjustment made pursuant to paragraph 1 if the conversion of the amounts expressed in euro would result in a change of less than 5 % when expressed in national currencies.Article 111. By the dates referred to in the second subparagraph of Article 7(7), the Commission shall present a report to the European Parliament and the Council on the implementation of this Directive, taking account of developments in technology and traffic congestion.2. Member States shall forward the necessary information to the Commission no later than six months before the dates referred to in paragraph 1 in order to enable the Commission to draw up the above report.3. Member States introducing electronic toll and/or user-charging systems shall cooperate with the aim of achieving an appropriate level of interoperability.Article 121. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by l July 2000. They shall forthwith inform the Commission thereof.When Member States adopt such measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such a reference shall be adopted by Member States.2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof.Article 13This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 14This Directive is addressed to the Member States.Done at Luxembourg, 17 June 1999.For the European ParliamentThe PresidentJ. M. GIL-ROBLESFor the CouncilThe PresidentF. MÜNTEFERING(1) OJ C 59, 26.2.1997, p. 9.(2) OJ C 206, 7.7.1997, p. 17.(3) Opinion delivered on 3 June 1999 (not yet published in the Official Journal).(4) Opinion of the European Parliament of 17 July 1997 (OJ C 286, 22.9.1997, p. 217), Council Common Position of 18 January 1999 (OJ C 58, 1.3.1999, p. 1) and Decision of the European Parliament of 7 May 1999 (not yet published in the Offcial Journal).(5) OJ L 316, 31.10.1992, p. 12. Directive as last amended by Directive 94/74/EC (OJ L 365, 31.12.1994, p. 46).(6) OJ L 316, 31.10.1992, p. 19. Directive as amended by Directive 94/74/EC. [1995] ECR I-1827.(7) OJ L 36, 9.2.1988, p. 33. Directive as last amended by Directive 96/1/EC (OJ L 40, 17.2.1996, p. 1).(8) OJ L 279, 12.11.1993, p. 32.(9) OJ L 359, 31.12.1998, p. 1.(10) OJ L 36, 9.2.1988, p. 33. Directive as last amended by Directive 96/1/EC (OJ L 40, 17.2.1996, p. 1).(11) OJ L 368, 17.12.1992, p. 38.(12) OJ 23, 3.4.1962, p. 720/62. Decision as last amended by Decision 73/402/EEC (OJ L 347, 17.12.1973, p. 48).ANNEX IMINIMUM RATES OF TAX TO BE APPLIED TO VEHICLES>TABLE>>TABLE>ANNEX IIMAXIMUM AMOUNTS IN EURO OF USER CHARGES, INCLUDING ADMINISTRATIVE COSTS, REFERRED TO IN ARTICLE 7(7)Annual>TABLE>Monthly and weeklyMaximum monthly and weekly rates are in proportion to the duration of the use made of the infrastructure.DailyThe daily user charge is equal for all vehicle categories and amounts to EUR 8.


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31989L0341

Council Directive 89/341/EEC of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products

Official Journal L 142 , 25/05/1989 P. 0011 - 0013 Finnish special edition: Chapter 13 Volume 19 P. 0009  Swedish special edition: Chapter 13 Volume 19 P. 0009

COUNCIL DIRECTIVE of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (89/341/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas the essential aim of any rules governing the production, distribution or use of medicinal products must be to safeguard public health;  Whereas the Directives on the approximation of the laws relating to proprietary medicinal products must be adapted to scientific progress and take account of the experience obtained since their adoption so as to ensure improved quality and greater  safety and efficacy;  Whereas, in its conclusions of 15 May 1987 on improvement in the use of proprietary medicinal products by consumers (4), the Council considered that the system for leaflets accompanying proprietary medicinal products, for human consumption, on the  market in the Community should be improved;  Whereas the guarantees of the quality of medicinal products manufactured within the Community should be maintained by requiring compliance with the principles of good manufacturing practice for medicinal products irrespective of the final destination of  the products;  Whereas the Commission should be empowered to define in detail the principles of good manufacturing practice for medicinal products in close cooperation with the Committee for Adaptation to Technical Progress of the Directives on the Removal of  Technical Barriers in the Proprietary Medicinal Products Sector;  Whereas, having regard to the resolution of the European Parliament of 13 June 1986 on the export of pharmaceutical  16. 5. 1989.   products to the Third World, measures should be taken to improve the provision of information for third countries on the conditions of use of medicinal products within the Member States;  Whereas the scope of Directive 65/65/EEC (5), as last amended by Directive 87/21/EEC (6), of Directive 75/318/EEC (7), as last amended by Directive 87/19/EEC (8), and of Second Directive 75/319/EEC (9), as last amended by Directive 83/570/EEC (10),  should be extended to cover other industrially produced medicinal products hitherto excluded,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Directive 65/65/EEC is hereby amended as follows:  1.  In the title, preamble and Chapters II to V, all references to 'proprietary medicinal product' are replaced by 'medicinal product'.  2.  In Article 1, the following points are inserted:  '4.  Magistral formula:  Any medicinal product prepared in a pharmacy in accordance with a prescription for an individual patient.  5.  Official formula:  Any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the patients served by the pharmacy in question.' 3.  Article 2 is replaced by the following:  'Article 2 1.  Chapters II to V shall apply to proprietary medicinal products for human use intended to be placed on the market in Member States.  ¹ ¹ ¹ ¹ ¹ 2.  Where a Member State authorizes the placing on the market of industrially produced medicinal products which do not comply with the definition of a proprietary medicinal product, it shall also apply Chapters II to V to them.  3.  Chapters II to V shall not apply to:  - medicinal products prepared on the basis of a magistral or official formula,  - medicinal products intended for research and development trials,  - intermediate products intended for further processing by an authorized manufacturer.  4.  A Member State may, in accordance with legislation in force and to fulfil special needs, exclude from Chapters II to V medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an  authorized health care professional and for use by his individual patients on his direct personal responsibility.' 4.  In Article 4a, the following point is added:  '6.6. special precautions for disposal of unused products or waste materials derived from such products, if appropriate.' 5.  In Article 13, the following point is added:  '9. special precautions for disposal of unused products or waste materials derived from such products, if appropriate.' 6.  In Article 14, the following fifth indent is added:  '- manufacturer's batch number.' Article 2 In Directive 75/318/EEC all references to 'proprietary medicinal product' or to 'proprietary product' are replaced by 'medicinal product'.  Article 3 Directive 75/319/EEC is hereby amended as follows:   1.  In Article 4, (b) is replaced by the following:  '(b)  may submit the medicinal product, its starting materials and, if need be, its intermediate products or other constituent materials for testing by a State laboratory or by a laboratory designated for that purpose in order to ensure that the control  methods employed by the manufacturer and described in the particulars accompanying the application in accordance with the second subparagraph of point 7 of Article 4 of Directive 65/65/EEC are satisfactory.'  2.  In Article 6, the last subparagraph is replaced by the following:  'The inclusion of a package leaflet in the packaging of medicinal products shall be obligatory unless all the information required by this Article is directly conveyed on the container itself and the outer packaging.'  3.  Article 16, (1) is replaced by the following:  '1.  Member States shall take all appropriate measures to ensure that the manufacture of medicinal products is subject to the holding of an authorization. This manufacturing authorization shall be required notwithstanding that the medicinal products  manufactured are intended for export.'  4.  In Article 19, the following point is added:  '(f)  to comply with the principles and guidelines of good manufacturing practice for medicinal products as laid down by Community law.'  5.  The following Article is inserted:  'Article 19a The principles and guidelines of good manufacturing practices for medicinal products referred to in Article 19 (f) shall be adopted in the form of a directive addressed to the Member States, in accordance with the procedure laid down in Article 2c of  Directive 75/318/EEC. Detailed guidelines in line with those principles will be published by the Commission and revised as necessary to take account of technical and scientific progress.'  6.  In Article 26:  - the first subparagraph is replaced by the following:  'The competent authority of the Member State concerned shall ensure, by means of repeated inspections, that the legal requirements governing medicinal products are complied with.',  - the following subparagraph is inserted:  'After every inspection as referred to in the first subparagraph, the officials representing the competent authority shall report on whether the manufacturer complies with the principles and guidelines of good manufacturing practice laid down by  Community law. The content of such reports shall be communicated to the manufacturer who has to undergo the inspection.'  7.  The following Article is inserted:  'Article 28a At the request of the manufacturer, the exporter or the authorities of an importing third country, Member States shall certify that a manufacturer of medicinal products is in possession of the authorization referred to in Article 16 (1). When issuing such certificates they shall comply with the following conditions:  1.  Member States shall have regard to the prevailing administrative arrangements of the World Health Organization.  2.  For medicinal products intended for export which are already authorized on their territory, they shall supply the summary of the product characteristics as approved in accordance with Article 4 (b) of Directive 65/65/EEC.  3.  When the manufacturer is not in possession of a marketing authorization he shall provide the authorities responsible for establishing the certificate referred to above with a declaration explaining why no marketing authorization is available.'  8.  In Article 30, the following subparagraph is added:  'Upon reasoned request, Member States shall forthwith communicate the reports referred to in the third subparagraph of Article 26 to the competent authorities of another Member State. If, after considering the reports, the Member State receiving the  reports considers that it cannot accept the conclusions reached by the competent authorities of the Member State in which the report was established, it shall inform the competent authorities concerned of its reasons and may request further information.  The Member States concerned shall use their best endeavours to reach agreement. If necessary, in the case of serious differences of opinion, the Commission shall be informed by one of the Member States concerned.'  9.  The following paragraphs are added to Article 33:  '2.  The person responsible for the marketing of a medicinal product shall be obliged to notify the Member States concerned forthwith of any action taken by him to suspend the marketing of a product or to withdraw a product from the market, together  with the reasons for such action if the latter concerns the efficacy of the medicinal product or the protection of public health. Member States shall ensure that this information is brought to the attention of the committee.  3.  Member States shall ensure that appropriate information about action taken pursuant to paragraphs 1 and 2 which may affect the protection of public health in third countries is forthwith brought to the attention of the World Health Organization,  with a copy to the committee.  4.  The Commission shall publish annually a list of the medicinal products which are prohibited in the Community.' 10.  The first paragraph of Article 34 is hereby amended as follows:  'This Directive shall apply to medicinal products for human use within the limits referred to in Article 2 of Directive 65/65/EEC.' Article 4 1.  Member States shall take the measures necessary to comply with this Directive before 1 January 1992. They shall forthwith inform the Commission thereof.  2.  Requests for marketing authorizations lodged after the time limit referred to in paragraph 1 must comply with this Directive.  3.  Articles 1, 2 and 3, where relevant, shall be progressively extended to existing medicinal products before 31 December 1992.  Article 5 This Directive is addressed to the Member States.   Done at Brussels, 3 May 1989.  For the Council The President P. SOLBES  (1) OJ No C 36, 8. 2. 1988, p. 22. (2) OJ No C 290, 14. 11. 1988, p. 128; OJ No C 120, (3) OJ No C 208, 8. 8. 1988, p. 64. (4) OJ No C 178, 7. 7. 1987, p. 2.(5) OJ No 22, 9. 2. 1965, p. 369/65.(6) OJ No L 15, 17. 1. 1987, p. 36.(7) OJ No L 147, 9. 6. 1975, p. 1.(8) OJ No L 15, 17. 1. 1987, p. 31.(9) OJ No L 147, 9. 6. 1975, p. 13. (10) OJ No L 332, 28. 11. 1983, p. 1.


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31995L0050

Council Directive 95/50/EC of 6 October 1995 on uniform procedures for checks on the transport of dangerous goods by road

Official Journal L 249 , 17/10/1995 P. 0035 - 0040

COUNCIL DIRECTIVE 95/50/EC of 6 October 1995 on uniform  procedures for checks on the transport of dangerous goods by roadTHE COUNCIL OF  THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 75  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 189c of the Treaty  (3), Whereas the Community has adopted a number of measures for the establishment of an internal market  comprising an area without internal frontiers in which the free movement of goods, persons,  services and capital is ensured in accordance with the provisions of the Treaty; Whereas checks on the transport of dangerous goods by road are carried out in accordance with  Council Regulation (EEC) No 4060/89 of 21 December 1989 on the elimination of controls performed at  the frontiers of Member States in the field of road and inland waterway transport  (4) and Council  Regulation (EEC) No 3912/92 of 17 December 1992 on controls carried out within the Community in the  field of road and inland waterway transport in respect of means of transport registered or put into  circulation in a third country  (5); Whereas the Council has adopted Directive 94/55/EC of 21 November 1994 on the approximation of the  laws of the Member States with regard to the transport of dangerous goods by road  (6); whereas the  respective procedures for checking and the definitions relating to this type of transport should  accordingly be harmonized in order for compliance with the safety standards laid down therein to be  verified more effectively; Whereas the Member States should ensure a sufficient level of checks on the vehicles concerned  throughout their territory while, where possible, avoiding the proliferation of such checks; Whereas, in the light of the principle of subsidiarity, Community action is therefore necessary to  improve the level of safety of the transport of dangerous goods; Whereas checks should be carried out using a list of common items applicable to such transport  throughout the Community; Whereas it is necessary to draw up a list of infringements deemed sufficiently serious by all  Member States to result in the application to the vehicles concerned of appropriate measures  depending on the circumstances or the requirements of safety, including, where appropriate, refusal  to admit the vehicles concerned to the Community; Whereas, in order to improve compliance with saftey standards for the transport of dangerous goods  by road, it is necessary to make provision for checks to be carried out in undertakings as a  preventive measure or when serious infringements of laws on the transport of dangerous goods have  been recorded at the roadside; Whereas the checks in question must apply to all consignments of dangerous goods transported by  road wholly or partly within the territory of the Member States, irrespective of the point of  departure or the destination of the goods or the country in which the vehicle is registered; Whereas, in the event of serious or repeated infringements, the competent authorities of the Member  State in which the vehicle is registered or in which the undertaking is established may be asked to  take appropriate measures and whereas they shall inform the requesting Member State of any  follow-up measures taken; Whereas the application of this Directive should be monitored on the basis of a report to be  submitted by the Commission, HAS ADOPTED THIS DIRECTIVE: Article 1 1.  This Directive shall apply to checks carried out by Member States  on the transport of dangerous goods by road in vehicles travelling in their territory or entering  it from a third country. It shall not apply to the transport of dangerous goods by vehicles belonging to or under the  responsibility of the armed forces. 2.  This Directive shall not, however, affect the Member States' right, with due regard to  Community law, to carry out checks on the national and international transport of dangerous goods  within their territories performed by vehicles not covered by this Directive. Article 2 For the purposes of this Directive: -  'vehicle` shall mean any motor vehicle intended for use on the road, whether complete or  incomplete, which has at least four wheels and a maximum design speed exceeding 25 km/h, together  with its trailers, with the exception of vehicles which run on rails, of agricultural and forestry  tractors and of all mobile machinery, -  'dangerous goods` shall mean dangerous goods defined as such in Directive 94/55/EC, -  'transport` shall mean any road transport operation performed by a vehicle wholly or partly on  public roads within the territory of a Member State, including the loading and unloading of goods  covered by Directive 94/55/EC, without prejudice to the arrangements laid down by the laws of the  Member States concerning liability in respect of such operations, -  'undertaking` shall mean any natural or legal person, whether or not profit-seeking, any  association or group of persons without legal personality, whether or not profit-seeking, and any  body coming under a public authority, whether itself possessing legal personality or dependent on  an authority having such personality, which carry, load or unload dangerous goods or cause them to  be carried and those which temporarily store, collect, package or take delivery of such goods as  part of a transport operation and are located in the territory of the Community, -  'check` shall mean any check, control, inspection, verification or formality carried out by the  competent authorities for reasons of safety inherent in the transport of dangerous goods. Article 3 1.  The Member States shall ensure that a representative proportion of consignments of  dangerous goods transported by road is subject to the checks laid down by this Directive, in order  to check their compliance with the laws on the transport of dangerous goods by road. 2.  Such checks shall be carried out in the territory of a Member State in accordance with Article  3 of Regulation (EEC) No 4060/89 and Article 1 of Regulation (EEC) No 3912/92. Article 4 1.  In order to carry out the checks provided for in this Directive, the Member States  shall use the checklist in Annex I. A copy of this checklist or a certificate showing the result of  the check drawn up by the authority which carried it out shall be given to the driver of the  vehicle and presented on request in order to simplify or avoid, where possible, subsequent checks.  This paragraph shall not prejudice Member States' right to carry out specific measures for detailed  checks. 2.  The checks shall be random and shall as far as possible cover an extensive portion of the road  network. 3.  The places chosen for these checks must permit infringing vehicles to be brought into  compliance or, if the authority carrying out the check deems it appropriate to be immobilized  on-the-spot or at a place desginated for that purpose by the said authority without causing a  safety hazard. 4.  Where appropriate and provided that this does not constitute a safety hazard, samples of the  goods transported may be taken for examination by laboratories recognized by the competent  authority. 5.  Checks shall not exceed a reasonable length of time. Article 5 Without prejudice to other penalties which may be imposed, vehicles in respect of which  one or more infringements of the rules on the transport of dangerous goods, in particular  infringements listed in Annex II, are established may be immobilized either on-the-spot or at a  place designated for this purpose by the authorities carrying out the check and required to be  brought into conformity before continuing their journey or may be subject to other appropriate  measures, depending on the circumstances or the requirements of safety including, where  appropriate, refusal to allow such vehicles to enter the Community. Article 6 1.  Checks may also be carried out at the premises of undertakings, as a preventive  measure or where infringements which jeopardize safety in the transport of dangerous goods have  been recorded at the roadside. 2.  The purpose of such checks shall be to ensure that safety conditions for the transport of  dangerous goods by road comply with the relevant laws. Where one or more infringements, in particular those listed in Annex II, have been established in  respect of the transport of dangerous goods by road, the transport in question shall be brought  into conformity before the goods leave the undertaking or shall be subject to other appropriate  measures. Article 7 1.  Member States shall assist one another in order to give proper effect to this  Directive. 2.  Serious or repeated infringements jeopardizing the safety of the transport of dangerous goods  committed by a non-resident vehicle or undertaking must be reported to the competent authorites in  the Member State in which the vehicle is registered or in which the undertaking is established. The competent authorities of the Member State in which serious or repeated infringements have been  recorded may ask the competent authorities of the Member State in which the vehicle is registered  or in which the undertaking is established for appropriate measures to be taken with regard to the  offender or offenders. The latter competent authorities shall notify the competent authorities of the Member State in  which the infringements were recorded of any measures taken with regard to the transporter or the  undertaking. Article 8 If the findings of a roadside check on a vehicle registered in another Member State  give grounds for believing that serious or repeated infringements have been committed which cannot  be detected in the course of that check in the absence of the necessary data, the competent  authorities of the Member States concerned shall assist one another in order to clarify the  situation. Where, to that end, the competent Member State carries out a check in the undertaking,  the other Member States concerned shall be notified of the results. Article 9 1.  Each Member State shall send the Commission for each calendar year not later than  twelve months after the end of that year a report, drawn up in accordance with the model in Annex  III, on the application of this Directive, including the following particulars: -  if possible, determined or estimated volume of dangerous goods transported by road (in tonnes  transported or in tonnes/kilometres), -  number of checks carried out, -  number of vehicles checked by place of registration (vehicles registered nationally, in other  Member States or in third countries), -  number and types of infringements recorded, -  type and number of penalties imposed. 2.  The Commission shall send the European Parliament and the Council, for the first time in 1999  and subsequently at least every three years, a report on the application of this Directive by the  Member States, stating the particulars in accordance with paragraph 1 above. Article 10 1.  Member States shall bring into force the laws, regulations and administrative  provisions necessary to comply with this Directive by 1 January 1997. They shall forthwith inform  the Commission thereof. When these provisions are adopted by the Member States, 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. 2.  Member States shall communicate to the Commission the text of the essential provisions of  domestic law which they adopt in the field governed by this Directive. Article 11 This Directive shall enter into force on the day of its publication in the Official  Journal of the European Communities. Article 12 This Directive is addressed to the Member States. Done at Luxembourg, 6 October 1995. For the Council The President J. BORRELL FONTELLES  ANNEX I >START OF GRAPHIC>CHECKLIST 1.  Place of check    2.  Date    3.  Time    4.  Vehicle nationality mark and registration number    5.  Trailer/semi-trailer nationality mark and registration number    6.  Type of vehicle    lorry    road train    articulated vehicle with platform 7.  Undertaking carrying out transport/address     8.  Nationality    9.  Driver    10.  Driver's mate    11.  Consignor, address, place of loading  (1)     12.  Consignee, address, place of unloading  (1)     13.  Gross mass of dangerous goods by transport unit    14.  Marginal 10  011 quantity limit exceeded    Yes    No 15.  Carried out by   fixed tank    removable tank    tank container    battery of receptacles   in bulk    container    package On board document(s) 16.  Transport/accompanying document(s)   inspected    infringement established    not applicable 17.  Written instructions   inspected    infringement established    not applicable 18.  Bilateral/multilateral agreement/national authorization   inspected    infringement  established    not applicable 19.  Vehicle approval certificate   inspected    infringement established    not applicable 20.  Driver's training certificate   inspected    infringement established    not applicable Circulation of vehicle  21.  Goods authorized for transport   inspected    infringement established    not applicable 22.  Bulk goods   inspected    infringement established    not applicable 23.  Tank transport   inspected    infringement established    not applicable 24.  Container transport   inspected    infringement established    not applicable 25.  Authorized goods for type of vehicle   inspected    infringement established    not applicable 26.  Prohibition of mixed loading   inspected    infringement established    not applicable 27.  Handling and storage  (2)   inspected    infringement established    not applicable 28.  Leakage of goods or damage to package  (2)   inspected    infringement established    not  applicable 29.  UN number/package labelling/UN packaging code  (1)  (2)   inspected    infringement  established    not applicable 30.  Vehicle and/or container marking   inspected    infringement established    not applicable 31.  Tank or bulk transport hazard label(s)   inspected    infringement established    not  applicable Vehicle equipment  32.  Tool set for temporary repairs   inspected    infringement established    not applicable 33.  At least one scotch per vehicle   inspected    infringement established    not applicable 34.  Two orange-coloured lights   inspected    infringement established    not applicable 35.  Fire extinguisher(s)   inspected    infringement established    not applicable 36.  Driver's personal protective equipment   inspected    infringement established    not  applicable  37.  Miscellaneous/remarks 38.  Authority/officer having carried out the inspection >END OF GRAPHIC> ANNEX II INFRINGEMENTS For the purposes of this Directive, the following in particular  shall be regarded as infringements: 1.  goods not authorized for transport; 2.  absence of consignor's declaration on the conformity of the goods and their packaging with  transport regulations; 3.  vehicles which, on checking, display leaks of dangerous substances due to the lack of leakproof  integrity of tanks or packages; 4.  vehicles with no type-approval certificate or with a non-regulation certificate; 5.  vehicles lacking appropriate orange panels or with non-regulation orange panels; 6.  vehicles without safety instructions or with inappropriate ones; 7.  inappropriate vehicle or packaging; 8.  driver without a regulation vocational training certificate for the carriage of dangerous goods  by road; 9.  vehicles lacking fire extinguishers; 10.  vehicles or packages without regulation danger labels; 11.  vehicles lacking transport/accompanying documents, or with particulars relating to the  dangerous goods on board which are not in compliance with the regulations; 12.  vehicles not covered by a bilateral/multilateral agreement or not in compliance with the  agreement; 13.  overfilling of tank.  ANNEX III MODEL STANDARD FORM FOR THE REPORT TO BE SENT TO THE COMMISSION CONCERNING  INFRINGEMENTS AND PENALTIES >START OF GRAPHIC>Country:   Year: .................... Roadside checks   Place of registration of vehicles  (1)  Country of check Other EU Member States Third countries Total number      Number of vehicles checked          Number of infringements noted according  to type of infringement          Number and type of penalties imposed          (1)  For the purposes of this Annex the country of registration is that of the motor vehicle. >END OF GRAPHIC>


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31996L0089

Commission Directive 96/89/EC of 17 December 1996 amending Directive 95/12/EC implementing Council Directive 92/75/EEC with regard to energy labelling of household washing machines (Text with EEA relevance)

Official Journal L 338 , 28/12/1996 P. 0085 - 0085

COMMISSION DIRECTIVE 96/89/EC of 17 December 1996 amending Directive 95/12/EC implementing Council Directive 92/75/EEC with regard to energy labelling of household washing machines (Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 92/75/EEC of 22 September 1992 on the indication by labelling and standard product information of the consumption of energy and other resources of household appliances (1) and in particular Articles 9 and 12 thereof,Having regard to Commission Directive 95/12/EC of 23 May 1995 implementing Council Directive 92/75/EEC with regard to energy labelling of household washing machines (2),Whereas current measurement methods and information do not allow for the appropriate labelling of washing machines without an integral method of heating hot water; whereas such appliances must therefore be excluded from the scope of Directive 95/12/EC;Whereas the measures provided for in this Directive are in accordance with the opinion of the committee set up under Article 10 of Directive 92/75/EEC,HAS ADOPTED THIS DIRECTIVE:Article 1 In Article 1 (1) of Directive 95/12/EC, in the list of types of household washing machine excluded from the scope of that Directive, the following item is added:'- Until 30 June 1998 machines with no internal means to heat water.`Article 2 1. Member States shall adopt and publish the laws, regulations and administrative provisions to comply with this Directive by 15 April 1997. They shall immediately notify the Commission of these measures. They shall apply those provisions from 15 May 1997.When Member States adopt these provisions either they shall contain a reference to this Directive, or shall be accompanied by such a reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.2. Member States shall communicate to the Commission any measures which they take in the field covered by this Directive.Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.Article 4 This Directive is addressed to the Member States.Done at Brussels, 17 December 1996.For the CommissionChristos PAPOUTSISMember of the Commission(1) OJ No L 297, 13. 10. 1992, p. 16.(2) OJ No L 136, 21. 6. 1995, p. 1.