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32001L0052

Commission Directive 2001/52/EC of 3 July 2001 amending Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs (Text with EEA relevance)

Official Journal L 190 , 12/07/2001 P. 0018 - 0020

Commission Directive 2001/52/ECof 3 July 2001amending Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption(1), as amended by Directive 94/34/EC(2) of the European Parliament and of the Council, and in particular Article 3(3)(a) thereof,After consulting the Scientific Committee on Food,Whereas:(1) Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on sweeteners for use in foodtuffs(3), as amended by Directive 96/83/EC(4), lists those substances which may be used as sweeteners in foodstuffs.(2) Commission Directive 95/31/EC of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in foodstuffs(5), as last amended by Directive 2000/51/EC(6), sets out the purity criteria for the sweeteners mentioned in Directive 94/35/EC.(3) It is necessary, in the light of technical progress, to amend the purity criteria set out in Directive 95/31/EC for mannitol (E 421) and acesulfme K (E 950).(4) It is necessary to take into account the specifications and analytical techiques for sweeteners as set out in the Codex alimentarius by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).(5) It is consequently necessary to adapt Directive 95/31/EC.(6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,HAS ADOPTED THIS DIRECTIVE:Article 1In the Annex to Directive 95/31/EC, the text concerning E 421 mannitol and E 950 acesulfame K shall be replaced by the text in the Annex to this Directive.Article 2Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 2002 at the latest. They shall forthwith inform the Commission thereof.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.Article 3This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.Article 4This Directive is addressed to the Member States.Done at Brussels, 3 July 2001.For the CommissionDavid ByrneMember of the Commission(1) OJ L 40, 11.2.1989, p. 27.(2) OJ L 237, 10.9.1994, p. 1.(3) OJ L 237, 10.9.1994, p. 3.(4) OJ L 48, 19.2.1997, p. 16.(5) OJ L 178, 28.7.1995, p. 1.(6) OJ L 198, 4.8.2000, p. 41.ANNEX">TABLE>"


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31993L0023

Council Directive 93/23/EEC of 1 June 1993 on the statistical surveys to be carried out on pig production

Official Journal L 149 , 21/06/1993 P. 0001 - 0004 Finnish special edition: Chapter 3 Volume 50 P. 0042  Swedish special edition: Chapter 3 Volume 50 P. 0042

COUNCIL DIRECTIVE 93/23/EEC of 1 June 1993 on the statistical surveys to be carried out on pig productionTHE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,  Having regard to the proposal from the Commission(1) ,  Having regard to the opinion of the European Parliament(2) ,  Whereas Council Directive 76/630/EEC of 20 July 1976 concerning surveys of pig production made by Member States(3)  has been amended several times; and whereas, further amendments being necessary, the provisions thereof should, for reasons of clarity,  be recast;  Whereas provision should be made for those Member States whose pig population makes up only a small percentage of the overall population of the Community to reduce the number of annual surveys where appropriate;  Whereas, in order to ensure that the common agricultural policy is properly administered, particularly where the pigmeat market is concerned, the Commission requires regular data on trends in livestock and in pigmeat production;  Whereas the collection and processing of the data as well as the organization of the survey at national level should continue to lie within the competence of the statistical services of the Member States, and the Commission should be responsible for the  coordination and harmonization of statistical information at European level and arrange for the harmonized methodologies necessary to implement Community policies;  Whereas, in order to facilitate implementation of this Directive, close cooperation is necessary between the Member States and the Commission and this should be effected in particular via the Standing Committee on Agricultural Statistics set up by  Decision 72/279/EEC(4) ,  HAS ADOPTED THIS DIRECTIVE:  SECTION I SURVEYS OF THE POPULATION  A. At national level Frequency - field of survey Article 1  1.  The Member States shall carry out statistical surveys of the pig population on their territory each year with reference to one of the first days of April, August and December.  2.  The Member States may, at their request, be authorized to carry out the April and August surveys in selected regions, on the understanding that these surveys cover at least 70 % of the pig population.  Those Member States whose pig population is less than 3 million per head may be authorized to dispense with the April and August surveys altogether.  The Member States may, at their request, be authorized to use administrative sources instead of statistical surveys under paragraph 1.  3.  In considering the requests referred to in paragraph 2, the Commission shall decide in accordance with the procedure laid down in Article 17.  Article 2  1.  For the purposes of this Directive, the term 'pig' means domestic animals of the species Sus.  2.  The surveys referred to in Article 1 shall cover all pigs held on agricultural holdings as defined in accordance with the procedure laid down in Article 17. The surveys shall cover sufficient holdings to account for at least 95 % of the pig  population as determined by the last survey on the structure of agricultural holdings.  3.  As far as possible, Member States shall supplement the results of the surveys provided for in paragraph 2 with an estimate of the pig population not covered by the said surveys.  Breakdown by category Article 3  1.  The surveys provided for in Article 1 shall be conducted in such a way as to provide a breakdown of the pig population into at least the following categories:  A. piglets with a live weight of less than 20 kg;  B. pigs with a live weight of 20 kg or more but less than 50 kg;  C. fattening pigs, including cull boars and cull sows with a live weight:  (a) of 50 kg or more but less than 80 kg;  (b) of 80 kg or more but less than 110 kg;  (c) of 110 kg or more;  D. breeding pigs with a live weight of 50 kg and higher;  (a) boars;  (b) covered sows, of which:  (b1) sows covered for the first time;  (c) other sows, of which:  (c1) gilts not yet covered.  2.  The categories referred to in paragraph 1 may be modified in accordance with the procedure laid down in Article 17.  3.  The categories shall be defined in accordance with the procedure laid down in Article 17.  Accuracy Article 4  1.  The surveys referred to in Article 1 shall be conducted in the form of exhaustive surveys or by representative sampling.  2.  For each of the Member States, sampling errors for the results of the surveys provided for in Article 2 (2) shall not exceed 2 % (confidence interval of 68 %) of the total number of pigs.  3.  In addition to the sampling frame and the supplementary estimates referred to in Article 2 (3), Member States shall take whatever measures they deem appropriate to maintain the quality of the survey results.  Transmission deadline Article 5  1.  Member States shall notify the Commission of the provisional results of the surveys and supplementary estimates before:  - 15 June of the same year for the April survey,  - 15 October of the same year for the August survey,  - 15 February of the following year for the December survey.  2.  Member States shall notify the Commission of the results of the surveys and the supplementary estimates, as defined in Article 4 (2), before:  - 1 August of the same year for the April survey,  - 1 December of the same year for the August survey,   -1 April of the following year for the December survey.  B. At regional level Territorial subdivisions Article 6  1.  The final results of the December survey shall be compiled for each of the territorial subdivisions as defined in accordance with the procedure laid down in Article 17.  2.  In accordance with the procedure laid down in Article 17, the Commission may approve an application from a Member State to use the regional breakdown referred to in paragraph 1 for the final results of the April or August survey.  3.  The territorial subdivisions referred to in paragraph 1 may be amended by the Commission in accordance with the procedure laid down in Article 17.  Transmission deadline Article 7  The Member States shall notify the Commission of the data referred to in Article 6 before 15 May of the year following the reference month.  C. Breakdown by herd size Size classes Article 8  1.  In odd-numbered years, the Member States shall, at national level, break down the final results of the December surveys by size classes as defined in accordance with the procedure laid down in Article 17.  2.  In accordance with the procedure laid down in Article 17, the Commission may approve an application from a Member State to use the breakdown by size classes referred to in paragraph 1 for the final results of even-numbered years and/or for those of  a given month of the year.  3.  The size classes referred to in paragraph 1 may be amended in accordance with the procedure laid down in Article 17.  Transmission deadline Article 9  The Member States shall forward to the Commission the data referred to in Article 8 before 15 May of the year following the reference month.  SECTION II SLAUGHTERING STATISTICS   Article 10  1.  The Member States shall draw up monthly statistics relating to the number and carcase weight of pigs slaughtered in the slaughter-houses on their territory, the meat of which is deemed fit for human consumption.  If necessary, they shall also supply estimates of slaughterings not included in the returns, so that the statistics include all the pigs slaughtered on their territory.  2.  The statistics referred to in paragraph 1 shall be drawn up for the following category:  A. pigs, total.  3.  The carcase weight referred to in paragraph 1 and the category referred to in paragraph 2 shall be defined, in accordance with the procedure laid down in Article 17.  Transmission deadline Article 11  Member States shall inform the Commission of the results of the statistics referred to in Article 10 (1) within the two months following the reference month.  SECTION III PRODUCTION FORECASTS   Article 12  1.  The Member States shall use the survey results and other available information to produce forecasts, for each calendar quarter-year, of their supply of pigs.  This supply shall be expressed as the gross indigenous production which shall include all pigs slaughtered plus the balance of intra-Community and external trade in live pigs.  2.  The forecasts referred to in paragraph 1 shall be drawn up for the following category:  A. pigs, total.  3.  The definition of 'supply' referred to in paragraph 1 may be amended in accordance with the procedure laid down in Article 17.  Transmission deadline Article 13  The Member States shall forward the forecasts referred to in Article 12 (1) to the Commission at the following times and for the following three-month periods:  (a) before 15 February for forecasts up to the third quarter of the current year (inclusive);  (b) before 15 June for forecasts up to the first quarter of the following year (inclusive);  (c) before 15 October for forecasts up to the second quarter of the following year (inclusive).  SECTION IV GENERAL PROVISIONS   Article 14  The Member States shall forward to the Commission the data referred to in Articles 5, 7, 9, 11 and 13 in compliance with Council Regulation (Euratom, EEC) No 1588/90 of 11 June 1990 on the transmission of data subject to statistical  confidentiality of the Statistical Office of the European Communities(5) .  Article 15  The Commission shall examine, in consultation with the Member States:  (a) the results supplied;  (b) the technical problems which arise, in particular in preparing and carrying out the surveys and forecasts;  (c) the reliability of the survey results and estimates.  Article 16  The Member States shall inform the Commission of any methodological or other change which would considerably influence the statistics. This shall be done not later than three months after the change in question enters into force. The  Commission shall notify the other Member States of any such communication in the appropriate working parties.  Article 17  1.  Where the procedure laid down in this Article is to be followed, the chairman of the Standing Committee on Agricultural Statistics (hereinafter referred to as the 'committee') shall refer the matter of the committee, either on his own  initiative or at the request of a representative of a Member State.  2.  The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter.  The opinion shall be delivered by a majority of 54 votes, the votes of the representatives of the Member States being weighted in the manner set out in Article 148 (2) of the Treaty. The chairman shall not vote.  3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.  (b) If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay submit to the Council a proposal relating to the measures to be taken. The Council shall act by a  qualified majority.  If, on the expiry of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.  Article 18  1.  Directive 76/630/EEC shall be repealed as from 1 January 1994.  2.  Any reference made to the repealed Directive shall be construed as referring to this Directive.  Article 19  The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1994.  When Member States 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 a reference shall be laid down by the Member  States.  Article 20  This Directive is addressed to the Member States.  Done at Luxembourg, 1 June 1993.  For the Council The President J. ANDERSEN   (1) OJ No C 18, 23. 1. 1993, p. 12.  (2) OJ No C 115, 26. 4. 1993.  (3) OJ No L 223, 16. 8. 1976, p. 4. Directive last amended by Regulation (EEC) No 1057/91 (OJ No L 107, 27. 4. 1991, p. 11).  (4) OJ No L 179, 7. 8. 1972, p. 1.  (5) OJ No L 151, 15. 6. 1990, p. 1.


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31986L0320

Commission Directive 86/320/EEC of 20 June 1986 amending Council Directive 66/402/EEC on the marketing of cereal seed

Official Journal L 200 , 23/07/1986 P. 0038 - 0038 Finnish special edition: Chapter 3 Volume 21 P. 0158  Swedish special edition: Chapter 3 Volume 21 P. 0158

*****COMMISSION  DIRECTIVE  of 20 June 1986  amending Council Directive 66/402/EEC on the marketing of cereal seed  (86/320/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (1), as last amended by Directive 86/155/EEC (2), and in particular Articles 2 (1a) and 21a thereof,  Whereas, in the light of the development of scientific and technical knowledge concerning the hybrids resulting from the crossing of species covered by Directive 66/402/EEC, the hybrids resulting from the crossing of Sorghum bicolor and Sorghum sudanense should, owing to their increased importance in the Community, be included in the scope of the Directive;  Whereas, in the light of the development of scientific and technical knowledge, Annex I to the said Directive should be amended in order to adapt the conditions to be satisfied by crops of Sorghum species;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 66/402/EEC is hereby amended as follows:  1. In Article 2 (1) (A) the following is added:  'This definition shall also cover the following hybrids resulting from the crossing of species referred to above.  1.2 // Sorghum bicolor (L.) Moench × Sorghum sudanense (Piper) Stapf.   // Hybrids resulting from the crossing of Sorghum and Sudan grass.  Unless otherwise specified, seed of the aforementioned hybrids shall be subject to the standards or other conditions applicable to seed of each of the species from which they are derived.'  2. In Annex I (3) (C) (b) the words 'of hybrid varieties' are inserted after the words 'certified seed'.  3. In Annex I (3) (C) the following is added:  '(c) crops of open pollinated varieties or synthetic varieties of Sorghum spp. shall conform to the following standards: the number of plants of the crop which are recognizable as obviously not being true to the variety shall not exceed:  - one per 30 m2 for the producton of basic seed,  - one per 10 m2 for the production of certified seed'.  Article 2  Member States shall take the measures necessary to comply with this Directive not later than 1 July 1987. They shall forthwith inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 20 June 1986.  For the Commission  Frans ANDRIESSEN  Vice-President  (1) OJ No 125, 11. 7. 1966, p. 2308/66.  (2) OJ No L 118, 7. 5. 1986, p. 23.


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31977L0312

Council Directive 77/312/EEC of 29 March 1977 on biological screening of the population for lead

Official Journal L 105 , 28/04/1977 P. 0010 - 0017 Finnish special edition: Chapter 15 Volume 2 P. 0063  Greek special edition: Chapter 05 Volume 2 P. 0174  Swedish special edition: Chapter 15 Volume 2 P. 0063  Spanish special edition: Chapter 05 Volume 2 P. 0125  Portuguese special edition Chapter 05 Volume 2 P. 0125

COUNCIL DIRECTIVE  of 29 March 1977  on biological screening of the population for lead  (77/312/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 235 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 one of the essential tasks of the European Economic Community is to promote throughout the Community a harmonious development of economic activities and a continuous and balanced expansion, neither of which can be achieved without combating pollution and nuisances and improving the quality of life and the protection of the environment;  Whereas the various uses of lead are at present causing contamination of many areas of the environment by this substance;  Whereas the many environmental sources of lead make it difficult to determine the total exposure of any one individual to this pollutant and therefore the protection of human health calls for the most accurate possible monitoring of the individual's total lead absorption;  Whereas biological screening of the population for lead should be carried out and the results of this screening evaluated so that, where appropriate, new proposals may be drawn up;  Whereas it is desirable to lay down the technical procedures and biological reference levels for such screening;  Whereas measurement of blood lead level is currently the best means of assessing the quantity of lead recently received by an individual as a result of exposure to environmental lead ; whereas the enzymatic activity of delta-aminolevulinic acid dehydratase (ALAD) may be used as an indicative or supplementary test for determining exposure to lead;  Whereas the programme of action of the European Communities on the environment (3) provides for the coordination of national programmes having as their aim the improvement of the quality of life and for priority investigation into lead,  HAS ADOPTED THIS DIRECTIVE:    Article 1 The Member States shall take the necessary steps to apply a common procedure for biological screening in order to assess the exposure of the population to lead outside the working environment.   Article 2 This common procedure, the application of which shall be restricted to four years, shall be based on the measurement of blood lead levels.  As an indicative or supplementary test, the ALAD measurement may also be used in accordance with the procedures laid down in Annexes II and III.  (1)OJ No C 28, 9.2.1976, p. 31. (2)OJ No C 50, 4.3.1976, p. 9. (3)OJ No C 112, 20.12.1973, p. 3.    Article 3 1. The conditions for biological screening shall be fixed by means of:    - sampling and analysis procedures,       - frequency of sampling.         2. Blood sampling shall be carried out on volunteers.   Article 4 Sampling shall be carried out on:    - groups of at least 100 persons in urban areas with more than 500 000 inhabitants,       - groups of at least 100 persons, in so far as this is feasible, chosen from among people exposed to significant sources of lead pollution,       - critical groups determined by the competent authorities in the Member States.         In each Member State and during each campaign the number of analyses to be performed shall be 50 or more per million inhabitants.   Article 5 The sampling of the groups referred to in Article 4 shall be carried out during at least two campaigns in each area investigated during the period of operation of the programme, separated by at least 24 months. In the second campaign, samples shall not necessarily be taken from the same persons as in the first campaign.   Article 6 In assessing the results of the biological screening for the purposes of the action provided for in Article 8, the following blood lead levels, which take into account the relationships between dose and effect given in Annex I, shall be taken together as reference levels:    - a maximum of 20 ¶g of Pb/100 ml of blood for 50 % of the group of people examined,       - a maximum of 30 ¶g of Pb/100 ml of blood for 90 % of the group of people examined,       - a maximum of 35 ¶g of Pb/100 ml of blood for 98 % of the group of people examined.          Article 7 Blood lead levels shall be determined as follows:    - Member States shall inform the Commission of the names of the laboratories taking part in the biological screening programme and of the methods of analysis used,       - the Commission, in conjunction with the Member States, shall organize inter-comparison programmes in which the abovementioned laboratories shall participate,       - the Commission, in conjunction with the Member States, shall examine the results of these programmes with a view to improving the comparability of the methods of analysis.          Article 8 Where the results of the analyses indicate that the reference levels set out in Article 6 have been exceeded in one or more cases Member States shall:    - check the validity of the results,       - take action to trace the exposure sources responsible for the levels being exceeded ; this shall also include action on all individuals with a blood lead level over 35 ¶g/100 ml,       - take all appropriate measures at the discretion of their competent national authorities.          Article 9 1. Within six months of notification of this Directive, the Member States shall designate the competent national authorities which shall forward to the Commission:    - the data relating to the biological screening of the population groups referred to in Article 4, together with details of the methods of analysis, the population groups examined and the areas in which samples have been taken ; complete anonymity shall be preserved as regards the persons examined ; the Commission and the Member States shall agree on the procedures and the method whereby these data shall be forwarded,       - information on the causes or factors presumed to have resulted in the reference levels in Article 6 being exceeded.         2. The competent national authority shall also notify the Commission of the measures taken pursuant to the third indent of Article 8.    Article 10 At least twice a year the Commission shall convene a meeting of representatives of the Governments of the Member States, which shall, in particular:    - ensure that implementation of the biological screening and in particular of the provisions of Articles 4 and 5 is harmonized,       - see that the analyses carried out are comparable,       - examine the information and facilitate the exchange of information between the Member States on the results of the biological screening and on the measures taken pursuant to Article 8.          Article 11 On the basis of the information collected pursuant to Article 9, the Commission shall draw up in cooperation with the competent national authorities:    - a collated annual report on the implementation of the programme, which shall be forwarded to the Member States, the Council and the European Parliament,       - a general report at the end of the programme which will form the basis for drawing up any further proposals taking account of progress made in scientific and technical knowledge.          Article 12 Member States shall take the necessary measures to enable the procedure laid down by this Directive to enter into force within 12 months following its notification and shall immediately inform the Commission thereof.   Article 13 This Directive is addressed to the Member States.     Done at Brussels, 29 March 1977.  For the Council  The President  T. BENN     ANNEX I RELATIONSHIPS BETWEEN DOSE AND EFFECT  The blood lead levels used in the assessment of the results of the biological screening are based on analysis of the scientific data concerning the various toxic effects of lead. With this analysis, which takes account of normal variations in biological values within the population, it is possible to establish quasi-quantitative relationships between dose and effect. The following relationships between dose and effect are used for references for the purposes of this Directive.  A decrease in ALAD activity in the red corpuscles as a result of exposure to lead may be tolerated for the population, provided that it does not interfere with haematopoiesis. For blood lead levels below 15 to 20 ¶g/100 ml, a decrease in ALAD activity is not currently considered to interfere with haematopoiesis.  An increase in the protoporphyrin content of erythrocytes in the blood (PPE) indicates interference with the body's use of iron and thus with synthesis of the haem. An increase in PPE has been found at blood lead levels over 20 to 30 ¶g/100 ml. An increase in PPE may however be due to other causes.  Interference with the glutathione synthesis may be tolerated only for a small fraction of the population and only if it is slight and does not result in any other sub-clinical symptoms. This unacceptable interference with glutathione synthesis is not found at blood lead levels below 30 ¶g/100 ml.  A significant increase in the excretion of delta-aminolevulinic acid in the urine (ALAU) is a significant sign of disturbance in the metabolism of porphyrins and thus a sign of health impairment. A statistically significant increase in ALAU begins to be found at blood levels above 35 ¶g/100 ml.  ANNEX II CORRESPONDENCE BETWEEN BLOOD LEAD LEVELS AND ENZYMATIC ACTIVITY  For the purposes of Article 2 of this Directive, the relationship between blood lead levels and ALAD enzymatic activity measured in accordance with the European standardized method (Annex III) shall be as follows: >PIC FILE= "T0010805">   If the ALAD values measured are significantly higher than the above limits for the different sections of population, confirmatory blood lead measurements shall not be required.    ANNEX III TECHNICAL INSTRUCTIONS FOR MEASURING ALAD ACTIVITY  European standardized method for determining the activity of delta-aminolevulinic acid dehydratase  The principle of the method adopted to determine the activity of delta-aminolevulinic acid dehydratase is well known. It is based on incubation of the enzyme with an excess of delta-aminolevulinic acid substrate. The porphobilinogen (PBG) which forms after a certain length of time is mixed with the modified Ehrlich reagent and the colour obtained is measured against white using a photometer. The quantity of porphobilinogen produced constitutes a measurement of ALAD activity.  METHOD Effect of light  Recent experiments have shown that PBG in particular is very sensitive to light. The entire analysis should thus be conducted with no direct sunlight at all in the laboratory (and not simply excluded from the point at which the analysis is carried out).  Phase one - Blood sampling and preservation before analysis    - Take a sample of 2 ml venous blood using a plastic syringe (not lead stabilized) in the presence of dried heparin (   - Prepare immediately and cool to 4 ºC four samples of 0 72 ml placed in plastic tubes (not lead stabilized). Graduated Marbourg-type pipettes should be used.       - If the samples are analyzed within three hours, there is no need to chill them.       - Samples should not be preserved at 4 ºC for longer than 24 hours.       - Just before analysis, all samples should be placed in a bath of iced water for 10 minutes.         Note : Plastics which may be used include, for example, polythene, polystyrene and polypropylene. The preservation period of 24 hours at 4 ºC is a cautious estimate. This interval is long enough for the sample to be removed for analysis from the point at which it was taken to a central laboratory. Three of the four blood samples are used to measure ALAD and the fourth as a blank.  Phase two - Haematocrit reading  This reading must be taken:    - at the same time as the blood sample,       - by a capillary method using two samples.         The sample should be centrifuged, after closing one end of the tube, at speed of a least 30 000 rev/minute and for not less than five minutes.  Note : This reading should preferably be taken at once, but in any case not later than 24 hours after the blood sample is taken. If possible a microhaematocrit centrifuge should be used.   Phase three - Haemolysis    - Take three blood samples which have been "thawed" using 1 73 ml distilled water (preheated to 37 ºC) and haemolyse for 10 minutes at 37 ± 0 72 ºC.       - Use, for preference, a 2 ml graduated pipette for adding the water and then mix thoroughly.       - Do not shake the samples at this stage.         Note : It has been decided that water should be used rather than Triton X 100 for the haemolysis. Haemolysis experiments using Triton X 100 resulted in a considerable slowing in ALAD activity which has not yet been accounted for and which might be an artifact.  Phase four - Addition of the ALA solution to the haemolysate    - Prepare the ALA solution.       - It should not be prepared more than five hours beforehand.       - Heat this solution to 37 ºC for at least 10 minutes before adding it.       - Add 1 ml of this solution to the haemolysate, preferably using a 1 ml volumetric pipette, and mix.         Note : A pH value of 6 74 has been taken, since experiments have shown that it is at this pH that there is the best correlation between ALAD activity and blood lead level in normal populations. It is not necessary to obtain the maximum activity (which can be done by raising the pH), since the activities to be measured are already fairly high.  Phase five - Preparation of the blank    - Take 0 72 ml of blood treated as when measuring ALAD up to the point where the ALA solution is added ; in place of this, add 1 ml of TCA-HgCl2 solution, 1 ml of ALA solution, and then proceed as when measuring ALAD (see below).       - Add the solutions using volumetric pipettes.         Note : Only one blank is compared against a series of three tests for each blood sample. If the OD obtained for the blank is very high, the operation should be repeated to check it.  Phase six - Incubation    - 60 minutes at 37 ± 0 72 ºC in a water bath.       - Incubation time runs from addition of the ALA solution.         Note : The incubation period of 60 minutes was chosen in order to increase ALAD activity by natural means, given that no other phase leads to any artificial increase in activity. Experiments have shown that the incubation time/activity ratio is linear for intervals over two hours.  The incubation temperature has been kept at 37 ºC for practical reasons.  Phase seven - Halting the PBG reaction  - Add 1 ml of TCA-HgCl2 solution to the incubation mixture, preferably using a 1 ml volumetric pipette.  Phase eight - Centrifugation and filtration    - 30 000 rev/minute.       - Filtration using Whatman No 54 paper or equivalent (acid-resistant).          Note : Centrifugation should last about 10 minutes. The filtration phase is included in order to avoid the transfer by pipette of small particles on to the surface of the supernatant liquid. These particles seem to produce a colour reaction with Ehrlich's reagent. A number of tests have shown that inclusion of the filtration phase leads to better reproducibility. This phase can if necessary be replaced by a second centrifugation.  Phase nine - Reaction with Ehrlich's reagent    - Mix 1 ml supernatant liquid with 1 ml modified Ehrlich's reagent, using a 1 ml volumetric pipette.       - Use a Vortex-type mixer to ensure that the mixture is homogeneous.       - Allow the reaction to continue for five minutes before measuring extinction.         Note : To obtain a homogeneous mixture it is very important to ensure that the filtered supernatant liquid is well mixed with the Ehrlich's reagent.  Phase ten - Extinction measurement    - Calibrate the spectrophotometer using a phenolphthaline solution in a basic buffer.       - Compare the extinction measurement of the sample with that of the blank at 555 nm in a 1 cm cell (or 2 cm if the absorption is very low).         Phase eleven - Calculation of enzyme activity  - The equation for calculating enzyme activity is as follows: >PIC FILE= "T0010806">   where:  OD = extinction measured,  60 = incubation time,  35 = dilution factor,  62 = molal extinction coefficient in cm2/¶mol,  K = spectrophotometric correction coefficient.   Note : The units proposed are consistent with the recommendations of the International Union of Biochemistry on enzyme nomenclature.  SOLUTIONS    1. Preparation of an ALA solution  Solution A:  1 778 g Na2HPO4  7 2H2O dissolved in 100 ml distilled water (preferably deionized).  Solution B:  1 738 g NaH2PO4  7 1H2O dissolved in 100 ml distilled water.  29 ml of solution A + 71 ml of solution B give a buffer of 0 71 M sodium phosphate at pH 6 74.  This buffer strength is necessary to prevent any fluctuation of pH value in the solution undergoing the reaction.  167 76 mg ALA-HCl are dissolved in solution B (which must always be acid) ; the pH is adjusted to 6 74 on the basis of solution A. The volume is then made up to 100 ml using the buffer solution of 0 71 M sodium phosphate at pH 6 74. This preparation gives a solution of 0 701 M ALA.        2. TCA-HgCl2 solution  1 735 g HgCl2 are dissolved in 100 ml 10 % trichloracetic acid.       3. Ehrlich's reagent solution  Reagents:  2 75 g p-dimethylaminobenzaldehyde (pDMAB),  0 725 g HgCl2 dissolved in 10 ml glacial acetic acid,  perchloric acid SG 1 77,  glacial acetic acid.  Preparation:  Dissolve the pDMAB in 50 ml acetic acid. Add 24 75 ml perchloric acid and 4 ml HgCl2 solution. Mix, cool and make up to 100 ml with the glacial acetic acid in a graduated flask (1). Store in a dark bottle.  Calibration:  Community-level calibration should be carried out every year by a laboratory jointly appointed by the Member States.  (1)If a brown coloration appears at this point, the reagent should be discarded.


Avis juridique important

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32004L0008

Directive 2004/8/EC of the European Parliament and of the Council of 11 February 2004 on the promotion of cogeneration based on a useful heat demand in the internal energy market and amending Directive 92/42/EEC

Official Journal L 052 , 21/02/2004 P. 0050 - 0060

Directive 2004/8/EC of the European Parliament and of the Councilof 11 February 2004on the promotion of cogeneration based on a useful heat demand in the internal energy market and amending Directive 92/42/EECTHE 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(1),Having regard to the opinion of the European 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 potential for use of cogeneration as a measure to save energy is underused in the Community at present. Promotion of high-efficiency cogeneration based on a useful heat demand is a Community priority given the potential benefits of cogeneration with regard to saving primary energy, avoiding network losses and reducing emissions, in particular of greenhouse gases. In addition, efficient use of energy by cogeneration can also contribute positively to the security of energy supply and to the competitive situation of the European Union and its Member States. It is therefore necessary to take measures to ensure that the potential is better exploited within the framework of the internal energy market.(2) Directive 2003/54/EC of the European Parliament and of the Council of 26 June 2003(5) establishes common rules for the generation, transmission, distribution and supply of electricity within the internal market in electricity. In this context, the development of cogeneration contributes to enhancing competition, also with regard to new market actors.(3) The Green Paper entitled "Towards a European strategy for the security of energy supply" points out that the European Union is extremely dependent on its external energy supplies currently accounting for 50 % of requirements and projected to rise to 70 % by 2030 if current trends persists. Import dependency and rising import ratios heighten the risk of interruption to or difficulties in supply. However, security of supply should not be conceived as merely a question of reducing import dependency and boosting domestic production. Security of supply calls for a wide range of policy initiatives aimed at, inter alia, diversification of sources and technologies and improved international relations. The Green Paper emphasised furthermore that security of energy supply is essential for a future sustainable development. The Green Paper concludes that the adoption of new measures to reduce energy demand is essential both in terms of reducing the import dependence and in order to limit greenhouse gas emissions. In its Resolution of 15 November 2001 on the Green Paper(6), the European Parliament called for incentives to encourage a shift towards efficient energy production plants, including combined heat and power.(4) The Commission's Communication "A Sustainable Europe for a better world - A European Union Strategy for Sustainable Development" presented at the Gothenburg European Council on 15 and 16 June 2001 identified climate change as one of the principal barriers to sustainable development and emphasised the need for increased use of clean energy and clear action to reduce energy demand.(5) The increased use of cogeneration geared towards making primary energy savings could constitute an important part of the package of measures needed to comply with the Kyoto Protocol to the United Nations Framework Convention on Climate Change, and of any policy package to meet further commitments. The Commission in its Communication on the implementation of the first phase of the European Climate Change Programme identified promotion of cogeneration as one of the measures needed to reduce the greenhouse gas emissions from the energy sector and announced its intention to present a proposal for a Directive on the promotion of cogeneration in 2002.(6) In its Resolution of 25 September 2002 on the Commission communication on the implementation of the first phase of the European Climate Change Programme(7), the European Parliament welcomes the idea of submitting a proposal to strengthen Community measures to promote the use of combined heat and power (CHP) and calls for prompt adoption of a Directive on the promotion of CHP.(7) The importance of cogeneration was also recognised by the Council Resolution of 18 December 1997(8) and by the European Parliament Resolution of 15 May 1998(9) on a Community strategy to promote combined heat and power.(8) The Council in its Conclusions of 30 May 2000 and of 5 December 2000 endorsed the Commission's Action Plan on energy efficiency and identified promotion of cogeneration as one of the short-term priority areas. The European Parliament in its Resolution of 14 March 2001 on the Action Plan on energy efficiency(10) called on the Commission to submit proposals establishing common rules for the promotion of cogeneration, where this makes environmental sense.(9) Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control(11), Directive 2001/80/EC of the European Parliament and of the Council of 23 October 2001 on the limitation of emissions of certain pollutants into the air from large combustion plants(12) and Directive 2000/76/EC of the European Parliament and of the Council of 4 December 2000 on the incineration of waste(13) highlight the need to evaluate the potential for cogeneration in new installations.(10) Directive 2002/91/EC of the European Parliament and of the Council of 16 December 2002 on the energy performance of buildings(14) requires the Member States to ensure that for new buildings with a total useful floor area of over 1000 m2, the technical, environmental and economic feasibility of alternative systems, such as cogeneration of heat and power, is considered and taken into account before construction starts.(11) High efficiency cogeneration is in this Directive defined by the energy savings obtained by combined production instead of separate production of heat and electricity. Energy savings of more than 10 % qualify for the term "high-efficiency cogeneration". To maximise the energy savings and to avoid energy savings being lost, the greatest attention must be paid to the functioning conditions of cogeneration units.(12) In the context of the evaluation of primary energy savings, it is important to take into account the situation of Member States in which the most of electricity consumption is covered by imports.(13) It is important for transparency to adopt a harmonised basic definition of cogeneration. Where cogeneration installations are equipped to generate separate electricity or heat production, such production should not be specified as cogeneration for issuing a guarantee of origin and for statistical purposes.(14) To ensure that support for cogeneration in the context of this Directive is based on the useful heat demand and primary energy savings, it is necessary to set up criteria to determine and assess the energy efficiency of the cogeneration production identified under the basic definition.(15) The general objective of this Directive should be to establish a harmonised method for calculation of electricity from cogeneration and necessary guidelines for its implementation, taking into account methodologies such as those currently under development by European standardisation organisations. This method should be adjustable to take account of technical progress. Application of the calculations in Annexes II and III to micro-cogeneration units could, in accordance with the principle of proportionality, be based on values resulting from a type testing process certified by a competent, independent body.(16) The definitions of cogeneration and of high-efficiency cogeneration used in this Directive do not prejudge the use of different definitions in national legislation, for purposes other than those set out in this Directive. It is appropriate to borrow in addition the relevant definitions contained in Directive 2003/54/EC and in Directive 2001/77/EC of the European Parliament and of the Council of 27 September 2001 on the promotion of electricity produced from renewable energy sources in the internal electricity market(15).(17) Measuring the useful heat output at the point of production of the cogeneration plant underlines the need to ensure that advantages of the cogenerated useful heat are not lost in high heat losses from distribution networks.(18) The power to heat ratio is a technical characteristic that needs to be defined in order to calculate the amount of electricity from cogeneration.(19) For the purpose of this Directive, the definition of "cogeneration units" may also include equipment in which only electrical energy or only thermal energy can be generated, such as auxiliary firing and after burning units. The output from such equipment should not be considered as cogeneration for issuing a guarantee of origin and for statistical purposes.(20) The definition of "small scale cogeneration" comprises, inter alia, micro-cogeneration and distributed cogeneration units such as cogeneration units supplying isolated areas or limited residential, commercial or industrial demands.(21) To increase transparency for the consumer's choice between electricity from cogeneration and electricity produced on the basis of other techniques, it is necessary to ensure that, on the basis of harmonised efficiency reference values, the origin of high-efficiency cogeneration can be guaranteed. Schemes for the guarantee of origin do not by themselves imply a right to benefit from national support mechanisms.(22) It is important that all forms of electricity produced from high-efficiency cogeneration can be covered by guarantees of origin. It is important to distinguish guarantees of origin clearly from exchangeable certificates.(23) To ensure increased market penetration of cogeneration in the medium term, it is appropriate to require all Member States to adopt and publish a report analysing the national potential for high-efficiency cogeneration and to include a separate analysis of barriers to cogeneration in the report, and of measures taken to ensure the reliability of the guarantee system.(24) Public support should be consistent with the provisions of the Community guidelines on State aid for environmental protection(16), including as regards the non-cumulation of aid. These guidelines currently allow certain types of public support if it can be shown that the support measures are beneficial in terms of protection of the environment because the conversion efficiency is particularly high, because the measures will allow energy consumption to be reduced or because the production process will be less damaging to the environment. Such support will in some cases be necessary to further exploit the potential for cogeneration, in particular to take account of the need to internalise external costs.(25) Public support schemes for promoting cogeneration should focus mainly on support for cogeneration based on economically justifiable demand for heat and cooling.(26) Member States operate different mechanisms of support for cogeneration at the national level, including investment aid, tax exemptions or reductions, green certificates and direct price support schemes. One important means to achieve the aim of this Directive is to guarantee the proper functioning of these mechanisms, until a harmonised Community framework is put into operation, in order to maintain investor confidence. The Commission intends to monitor the situation and report on experiences gained with the application of national support schemes.(27) For the transmission and distribution of electricity from high-efficiency cogeneration, the provisions of Article 7(1), (2) and (5) of Directive 2001/77/EC as well as relevant provisions of Directive 2003/54/EC should apply. Until the cogeneration producer is an eligible customer under national legislation within the meaning of Article 21(1) of Directive 2003/54/EC, tariffs related to the purchase of additional electricity sometimes needed by cogeneration producers should be set according to objective, transparent and non-discriminatory criteria. Especially for small scale and micro-cogeneration units access to the grid system of electricity produced from high-efficiency cogeneration may be facilitated subject to notification to the Commission.(28) In general, cogeneration units up to 400 kW falling within the definitions of Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels(17) are unlikely to meet the minimum efficiency requirements therein and should therefore be excluded from that Directive.(29) The specific structure of the cogeneration sector, which includes many small and medium-sized producers, should be taken into account, especially when reviewing the administrative procedures for obtaining permission to construct cogeneration capacity.(30) Within the purpose of this Directive to create a framework for promoting cogeneration it is important to emphasise the need for a stabile economical and administrative environment for investments in new cogeneration installations. Member States should be encouraged to address this need by designing support schemes with a duration period of at least four years and by avoiding frequent changes in administrative procedures etc. Member States should furthermore be encouraged to ensure that public support schemes respect the phase-out principle.(31) The overall efficiency and sustainability of cogeneration is dependent on many factors, such as technology used, fuel types, load curves, the size of the unit, and also on the properties of the heat. For practical reasons and based on the fact, that the use of the heat output for different purposes requires different temperature levels of the heat, and that these and other differences influence efficiencies of the cogeneration, cogeneration could be divided into classes such as: "industrial cogeneration", "heating cogeneration" and "agricultural cogeneration".(32) In accordance with the principles of subsidiarity and proportionality as set out in Article 5 of the Treaty, general principles providing a framework for the promotion of cogeneration in the internal energy market should be set at Community level, but the detailed implementation should be left to Member States, thus allowing each Member State to choose the regime, which corresponds best to its particular situation. This Directive confines itself to the minimum required in order to achieve those objectives and does not go beyond what is necessary for that purpose.(33) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June laying down the procedures for the exercise of implementing powers conferred on the Commission(18),HAVE ADOPTED THIS DIRECTIVE:Article 1PurposeThe purpose of this Directive is to increase energy efficiency and improve security of supply by creating a framework for promotion and development of high efficiency cogeneration of heat and power based on useful heat demand and primary energy savings in the internal energy market, taking into account the specific national circumstances especially concerning climatic and economic conditions.Article 2ScopeThis Directive shall apply to cogeneration as defined in Article 3 and cogeneration technologies listed in Annex I.Article 3DefinitionsFor the purpose of this Directive, the following definitions shall apply:(a) "cogeneration" shall mean the simultaneous generation in one process of thermal energy and electrical and/or mechanical energy;(b) "useful heat" shall mean heat produced in a cogeneration process to satisfy an economically justifiable demand for heat or cooling;(c) "economically justifiable demand" shall mean the demand that does not exceed the needs for heat or cooling and which would otherwise be satisfied at market conditions by energy generation processes other than cogeneration;(d) "electricity from cogeneration" shall mean electricity generated in a process linked to the production of useful heat and calculated in accordance with the methodology laid down in Annex II;(e) "back-up electricity" shall mean the electricity supplied through the electricity grid whenever the cogeneration process is disrupted, including maintenance periods, or out of order;(f) "top-up electricity" shall mean the electricity supplied through the electricity grid in cases where the electricity demand is greater than the electrical output of the cogeneration process;(g) "overall efficiency" shall mean the annual sum of electricity and mechanical energy production and useful heat output divided by the fuel input used for heat produced in a cogeneration process and gross electricity and mechanical energy production;(h) "efficiency" shall mean efficiency calculated on the basis of "net calorific values" of fuels (also referred to as "lower calorific values");(i) "high efficiency cogeneration" shall mean cogeneration meeting the criteria of Annex III;(j) "efficiency reference value for separate production" shall mean efficiency of the alternative separate productions of heat and electricity that the cogeneration process is intended to substitute;(k) "power to heat ratio" shall mean the ratio between electricity from cogeneration and useful heat when operating in full cogeneration mode using operational data of the specific unit;(l) "cogeneration unit" shall mean a unit that can operate in cogeneration mode;(m) "micro-cogeneration unit" shall mean a cogeneration unit with a maximum capacity below 50 kWe;(n) "small scale cogeneration" shall mean cogeneration units with an installed capacity below 1 MWe;(o) "cogeneration production" shall mean the sum of electricity and mechanical energy and useful heat from cogeneration.In addition, the relevant definitions in Directive 2003/54/EC, and in Directive 2001/77/EC shall apply.Article 4Efficiency criteria of cogeneration1. For the purpose of determining the efficiency of cogeneration in accordance with Annex III, the Commission shall, in accordance with the procedure referred to in Article 14(2), not later than 21 February 2006, establish harmonised efficiency reference values for separate production of electricity and heat. These harmonised efficiency reference values shall consist of a matrix of values differentiated by relevant factors, including year of construction and types of fuel, and must be based on a well-documented analysis taking, inter alia, into account data from operational use under realistic conditions, cross-border exchange of electricity, fuel mix and climate conditions as well as applied cogeneration technologies in accordance with the principles in Annex III.2. The Commission shall, in accordance with the procedure referred to in Article 14(2), review the harmonised efficiency reference values for separate production of electricity and heat referred to in paragraph 1, for the first time on 21 February 2011, and every four years thereafter, to take account of technological developments and changes in the distribution of energy sources.3. Member States implementing this Directive before the establishment by the Commission of harmonised efficiency reference values for separate production of electricity and heat referred to in paragraph 1, should, until the date referred to in paragraph 1, adopt their national efficiency reference values for separate production of heat and electricity to be used for the calculation of primary energy savings from cogeneration in accordance with the methodology set out in Annex III.Article 5Guarantee of origin of electricity from high-efficiency cogeneration1. On the basis of the harmonised efficiency reference values referred to in Article 4(1), Member States shall, not later than six months after adoption of these values, ensure that the origin of electricity produced from high-efficiency cogeneration can be guaranteed according to objective, transparent and non-discriminatory criteria laid down by each Member State. They shall ensure that this guarantee of origin of the electricity enable producers to demonstrate that the electricity they sell is produced from high efficiency cogeneration and is issued to this effect in response to a request from the producer.2. Member States may designate one or more competent bodies, independent of generation and distribution activities, to supervise the issue of the guarantee of origin referred to in paragraph 1.3. Member States or the competent bodies shall put in place appropriate mechanisms to ensure that the guarantee of origin are both accurate and reliable and they shall outline in the report referred to in Article 10(1) the measures taken to ensure the reliability of the guarantee system.4. Schemes for the guarantee of origin do not by themselves imply a right to benefit from national support mechanisms.5. A guarantee of origin shall:- specify the lower calorific value of the fuel source from which the electricity was produced, specify the use of the heat generated together with the electricity and finally specify the dates and places of production,- specify the quantity of electricity from high efficiency cogeneration in accordance with Annex II that the guarantee represents,- specify the primary energy savings calculated in accordance with Annex III based on harmonised efficiency reference values established by the Commission as referred to in Article 4(1).Member States may include additional information on the guarantee of origin.6. Such guarantees of origin, issued according to paragraph 1, should be mutually recognised by the Member States, exclusively as proof of the elements referred in paragraph 5. Any refusal to recognise a guarantee of origin as such proof, in particular for reasons relating to the prevention of fraud, must be based on objective, transparent and non-discriminatory criteria.In the event of refusal to recognise a guarantee of origin, the Commission may compel the refusing party to recognise it, particularly with regard to objective, transparent and non-discriminatory criteria on which such recognition is based.Article 6National potentials for high-efficiency cogeneration1. Member States shall establish an analysis of the national potential for the application of high-efficiency cogeneration, including high-efficiency micro-cogeneration.2. The analysis shall:- be based on well-documented scientific data and comply with the criteria listed in Annex IV,- identify all potential for useful heating and cooling demands, suitable for application of high-efficiency cogeneration, as well as the availability of fuels and other energy resources to be utilised in cogeneration,- include a separate analysis of barriers, which may prevent the realisation of the national potential for high-efficiency cogeneration. In particular, this analysis shall consider barriers relating to the prices and costs of and access to fuels, barriers in relation to grid system issues, barriers in relation to administrative procedures, and barriers relating to the lack of internalisation of the external costs in energy prices.3. Member States shall for the first time not later than 21 February 2007 and thereafter every four years, following a request by the Commission at least six months before the due date, evaluate progress towards increasing the share of high-efficiency cogeneration.Article 7Support schemes1. Member States shall ensure that support for cogeneration - existing and future units - is based on the useful heat demand and primary energy savings, in the light of opportunities available for reducing energy demand through other economically feasible or environmental advantageous measures like other energy efficiency measures.2. Without prejudice to Articles 87 and 88 of the Treaty, the Commission shall evaluate the application of support mechanisms used in Member States according to which a producer of cogeneration receives, on the basis of regulations issued by public authorities, direct or indirect support, which could have the effect of restricting trade.The Commission shall consider whether those mechanisms contribute to the pursuit of the objectives set out in Articles 6 and 174(1) of the Treaty.3. The Commission shall in the report referred to in Article 11 present a well-documented analysis on experience gained with the application and coexistence of the different support mechanisms referred to in paragraph 2 of this Article. The report shall assess the success, including cost-effectiveness, of the support systems in promoting the use of high-efficiency cogeneration in conformity with the national potentials referred to in Article 6. The report shall further review to what extent the support schemes have contributed to the creation of stable conditions for investments in cogeneration.Article 8Electricity grid system and tariff issues1. For the purpose of ensuring the transmission and distribution of electricity produced from high-efficiency cogeneration the provisions of Article 7(1), (2) and (5) of Directive 2001/77/EC as well as the relevant provisions of Directive 2003/54/EC shall apply.2. Until the cogeneration producer is an eligible customer under national legislation within the meaning of Article 21(1) of Directive 2003/54/EC, Member States should take the necessary measures to ensure that the tariffs for the purchase of electricity to back-up or top-up electricity generation are set on the basis of published tariffs and terms and conditions.3. Subject to notification to the Commission, Member States may particularly facilitate access to the grid system of electricity produced from high-efficiency cogeneration from small scale and micro cogeneration units.Article 9Administrative procedures1. Member States or the competent bodies appointed by the Member States shall evaluate the existing legislative and regulatory framework with regard to authorisation procedures or the other procedures laid down in Article 6 of Directive 2003/54/EC, which are applicable to high-efficiency cogeneration units.Such evaluation shall be made with a view to:(a) encouraging the design of cogeneration units to match economically justifiable demands for useful heat output and avoiding production of more heat than useful heat;(b) reducing the regulatory and non-regulatory barriers to an increase in cogeneration;(c) streamlining and expediting procedures at the appropriate administrative level; and(d) ensuring that the rules are objective, transparent and non-discriminatory, and take fully into account the particularities of the various cogeneration technologies.2. Member States shall - where this is appropriate in the context of national legislation - provide an indication of the stage reached specifically in:(a) coordination between the different administrative bodies as regards deadlines, reception and treatment of applications for authorisations;(b) the drawing up of possible guidelines for the activities referred to in paragraph 1, and the feasibility of a fast-track planning procedure for cogeneration producers; and(c) the designation of authorities to act as mediators in disputes between authorities responsible for issuing authorisations and applicants for authorisations.Article 10Member States' reporting1. Member States shall, not later than 21 February 2006, publish a report with the results of the analysis and evaluations carried out in accordance with Articles 5(3), 6(1), 9(1) and 9(2).2. Member States shall not later than 21 February 2007 and thereafter every four years, following a request by the Commission at least six months before the due date, publish a report with the result of the evaluation referred to in Article 6(3).3. Member States shall submit to the Commission, for the first time before the end of December 2004 covering data for the year 2003, and thereafter on an annual basis, statistics on national electricity and heat production from cogeneration, in accordance with the methodology shown in Annex II.They shall also submit annual statistics on cogeneration capacities and fuels used for cogeneration. Member States may also submit statistics on primary energy savings achieved by application of cogeneration, in accordance with the methodology shown in Annex III.Article 11Commission reporting1. On the basis of the reports submitted pursuant to Article 10, the Commission shall review the application of this Directive and submit to the European Parliament and to the Council not later than 21 February 2008 and thereafter every four years, a progress report on the implementation of this Directive.In particular, the report shall:(a) consider progress towards realising national potentials for high-efficiency cogeneration referred to in Article 6;(b) assess the extent to which rules and procedures defining the framework conditions for cogeneration in the internal energy market are set on the basis of objective, transparent and non-discriminatory criteria taking due account of the benefits of cogeneration;(c) examine the experiences gained with the application and coexistence of different support mechanisms for cogeneration;(d) review efficiency reference values for separate production on the basis of the current technologies.If appropriate, the Commission shall submit with the report further proposals to the European Parliament and the Council.2. When evaluating the progress referred to in paragraph 1(a), the Commission shall consider to what extent the national potentials for high-efficiency cogeneration, referred to in Article 6, have been or are foreseen to be realised taking into account Member State measures, conditions, including climate conditions, and impacts of the internal energy market and implications of other Community initiatives such as Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC(19).If appropriate, the Commission shall submit further proposals to the European Parliament and Council, notably aiming at the establishment of an action plan for the development of high efficiency cogeneration in the Community.3. When evaluating the scope for further harmonisation of calculation methods as referred to in Article 4(1), the Commission shall consider the impact of the coexistence of calculations as referred to in Article 12, Annex II and Annex III, on the internal energy market also taking into account the experiences gained from national support mechanisms.If appropriate, the Commission shall submit further proposals to the European Parliament and Council aiming at further harmonisation of the calculation methods.Article 12Alternative calculations1. Until the end of 2010 and subject to prior approval by the Commission, Member States may use other methods than the one provided for in Annex II(b) to subtract possible electricity production not produced in a cogeneration process from the reported figures. However, for the purposes referred to in Article 5(1) and in Article 10(3), the quantity of electricity from cogeneration shall be determined in accordance with Annex II.2. Member States may calculate primary energy savings from a production of heat and electricity and mechanical energy according to Annex III(c), without using Annex II to exclude the non-cogenerated heat and electricity parts of the same process. Such a production can be regarded as high-efficiency cogeneration provided it fulfils the efficiency criteria in Annex III(a) and, for cogeneration units with an electrical capacity larger than 25 MW, the overall efficiency is above 70 %. However, specification of the quantity of electricity from cogeneration produced in such a production, for issuing a guarantee of origin and for statistical purposes, shall be determined in accordance with Annex II.3. Until the end of 2010, Member States may, using an alternative methodology, define a cogeneration as high-efficiency cogeneration without verifying that the cogeneration production fulfils the criteria in Annex III(a), if it is proved on national level that the cogeneration production identified by such an alternative calculation methodology on average fulfils the criteria in Annex III(a). If a guarantee of origin is issued for such production then the efficiency of the cogeneration production specified on the guarantee shall not exceed the threshold values of the criteria in Annex III(a) unless calculations in accordance with Annex III prove otherwise. However, specification of the quantity of electricity from cogeneration produced in such a production, for issuing a guarantee of origin and for statistical purposes, shall be determined in accordance with Annex II.Article 13Review1. The threshold values used for calculation of electricity from cogeneration referred to in Annex II(a) shall be adapted to technical progress in accordance with the procedure referred to in Article 14(2).2. The threshold values used for calculation of efficiency of cogeneration production and primary energy savings referred to in Annex III(a) shall be adapted to technical progress in accordance with the procedure referred to in Article 14(2).3. The guidelines for determining the power to heat ratio referred to in Annex II(d) shall be adapted to technical progress in accordance with the procedure referred to in Article 14(2).Article 14Committee procedure1. The Commission shall be assisted by a 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 15TranspositionMember States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 21 February 2006. They shall forthwith inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The Member States shall lay down the methods of making such reference.Article 16Amendment to Directive 92/42/EECThe following indent shall be added to Article 3(1) of Directive 92/42/EEC:"- cogeneration units as defined in Directive 2004/8/EC of the European Parliament and of the Council of 11 February 2004 on the promotion of cogeneration based on useful heat demand in the internal energy market(20)."Article 17Entry into forceThis Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 18AddresseesThis Directive is addressed to the Member States.Done at Strasbourg, 11 February 2004.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentM. McDowell(1) OJ C 291 E, 26.11.2002, p. 182.(2) OJ C 95, 23.4.2003, p. 12.(3) OJ C 244, 10.10.2003, p. 1.(4) Opinion of the European Parliament of 13 May 2003 (not yet published in the Official Journal), Council Common Position of 8 September 2003 (not yet published in the Official Journal) and Position of the European Parliament of 18 December 2003 (not yet published in the Official Journal).(5) OJ L 176, 15.7.2003, p. 37.(6) OJ C 140 E, 13.6.2002, p. 543.(7) OJ C 273 E, 14.11.2003, p. 172.(8) OJ C 4, 8.1.1998, p. 1.(9) OJ C 167, 1.6.1998, p. 308.(10) OJ C 343, 5.12.2001, p. 190.(11) OJ C 257, 10.10.1996, p. 26.(12) OJ L 309, 27.11.2001, p. 1.(13) OJ L 332, 28.12.2000, p. 91.(14) OJ L 1, 4.1.2003, p. 65.(15) OJ L 283, 27.10.2001, p. 33.(16) OJ C 37, 3.2.2001, p. 3.(17) OJ L 167, 22.6.1992, p. 17. Directive as last amended by Directive 93/68/EEC (OJ L 220, 30.8.1993, p. 1).(18) OJ L 184, 17.7.1999, p. 23.(19) OJ L 275, 25.10.2003, p. 32.(20) OJ L 52, 21.2.2004, p. 50.ANNEX ICogeneration technologies covered by this Directive(a) Combined cycle gas turbine with heat recovery(b) Steam backpressure turbine(c) Steam condensing extraction turbine(d) Gas turbine with heat recovery(e) Internal combustion engine(f) Microturbines(g) Stirling engines(h) Fuel cells(i) Steam engines(j) Organic Rankine cycles(k) Any other type of technology or combination thereof falling under the definition laid down in Article 3(a)ANNEX IICalculation of electricity from cogenerationValues used for calculation of electricity from cogeneration shall be determined on the basis of the expected or actual operation of the unit under normal conditions of use. For micro-cogeneration units the calculation may be based on certified values.(a) Electricity production from cogeneration shall be considered equal to total annual electricity production of the unit measured at the outlet of the main generators;(i) in cogeneration units of type (b), (d), (e), (f), (g) and (h) referred to in Annex I, with an annual overall efficiency set by Member States at a level of at least 75 %, and(ii) in cogeneration units of type (a) and (c) referred to in Annex I with an annual overall efficiency set by Member States at a level of at least 80 %.(b) In cogeneration units with an annual overall efficiency below the value referred to in paragraph (a)(i) (cogeneration units of type (b), (d), (e), (f), (g), and (h) referred to in Annex I) or with an annual overall efficiency below the value referred to in paragraph (a)(ii) (cogeneration units of type (a) and (c) referred to in Annex I) cogeneration is calculated according to the following formula:E CHP = HCHP. Cwhere:E CHP is the amount of electricity from cogenerationC is the power to heat ratioHCHP is the amount of useful heat from cogeneration (calculated for this purpose as total heat production minus any heat produced in separate boilers or by live steam extraction from the steam generator before the turbine).The calculation of electricity from cogeneration must be based on the actual power to heat ratio. If the actual power to heat ratio of a cogeneration unit is not known, the following default values may be used, notably for statistical purposes, for units of type (a), (b), (c), (d), and (e) referred to in Annex I provided that the calculated cogeneration electricity is less or equal to total electricity production of the unit:>TABLE>If Member States introduce default values for power to heat ratios for units of type (f), (g), (h), (i), (j) and (k) referred to in Annex I, such default values shall be published and shall be notified to the Commission.(c) If a share of the energy content of the fuel input to the cogeneration process is recovered in chemicals and recycled this share can be subtracted from the fuel input before calculating the overall efficiency used in paragraphs (a) and (b).(d) Member States may determine the power to heat ratio as the ratio between electricity and useful heat when operating in cogeneration mode at a lower capacity using operational data of the specific unit.(e) The Commission shall, in accordance with the procedure referred to in Article 14(2), establish detailed guidelines for the implementation and application of Annex II, including the determination of the power to heat ratio.(f) Member States may use other reporting periods than one year for the purpose of the calculations according to paragraphs (a) and (b).ANNEX IIIMethodology for determining the efficiency of the cogeneration processValues used for calculation of efficiency of cogeneration and primary energy savings shall be determined on the basis of the expected or actual operation of the unit under normal conditions of use.(a) High-efficiency cogenerationFor the purpose of this Directive high-efficiency cogeneration shall fulfil the following criteria:- cogeneration production from cogeneration units shall provide primary energy savings calculated according to point (b) of at least 10 % compared with the references for separate production of heat and electricity,- production from small scale and micro cogeneration units providing primary energy savings may qualify as high-efficiency cogeneration.(b) Calculation of primary energy savingsThe amount of primary energy savings provided by cogeneration production defined in accordance with Annex II shall be calculated on the basis of the following formula:>PIC FILE= "L_2004052EN.005902.TIF">Where:PES is primary energy savings.CHP Hη is the heat efficiency of the cogeneration production defined as annual useful heat output divided by the fuel input used to produce the sum of useful heat output and electricity from cogeneration.Ref Hη is the efficiency reference value for separate heat production.CHP Eη is the electrical efficiency of the cogeneration production defined as annual electricity from cogeneration divided by the fuel input used to produce the sum of useful heat output and electricity from cogeneration. Where a cogeneration unit generates mechanical energy, the annual electricity from cogeneration may be increased by an additional element representing the amount of electricity which is equivalent to that of mechanical energy. This additional element will not create a right to issue guarantees of origin in accordance with Article 5.Ref Eη is the efficiency reference value for separate electricity production.(c) Calculations of energy savings using alternative calculation according to Article 12(2)If primary energy savings for a process are calculated in accordance with Article 12(2) the primary energy savings shall be calculated using the formula in paragraph (b) of this Annex replacing:"CHP Hη" with "Hη" and"CHP Eη" with "Eη",where:Hη shall mean the heat efficiency of the process, defined as the annual heat output divided by the fuel input used to produce the sum of heat output and electricity output.Eη shall mean the electricity efficiency of the process, defined as the annual electricity output divided by the fuel input used to produce the sum of heat output and electricity output. Where a cogeneration unit generates mechanical energy, the annual electricity from cogeneration may be increased by an additional element representing the amount of electricity which is equivalent to that of mechanical energy. This additional element will not create a right to issue guarantees of origin in accordance with Article 5.(d) Member States may use other reporting periods than one year for the purpose of the calculations according to paragraphs (b) and (c) of this Annex.(e) For micro-cogeneration units the calculation of primary energy savings may be based on certified data.(f) Efficiency reference values for separate production of heat and electricityThe principles for defining the efficiency reference values for separate production of heat and electricity referred to in Article 4(1) and in the formula set out in paragraph (b) of this Annex shall establish the operating efficiency of the separate heat and electricity production that cogeneration is intended to substitute.The efficiency reference values shall be calculated according to the following principles:1. For cogeneration units as defined in Article 3, the comparison with separate electricity production shall be based on the principle that the same fuel categories are compared.2. Each cogeneration unit shall be compared with the best available and economically justifiable technology for separate production of heat and electricity on the market in the year of construction of the cogeneration unit.3. The efficiency reference values for cogeneration units older than 10 years of age shall be fixed on the reference values of units of 10 years of age.4. The efficiency reference values for separate electricity production and heat production shall reflect the climatic differences between Member States.ANNEX IVCriteria for analysis of national potentials for high-efficiency cogeneration(a) The analysis of national potentials referred to in Article 6 shall consider:- the type of fuels that are likely to be used to realise the cogeneration potentials, including specific considerations on the potential for increasing the use of renewable energy sources in the national heat markets via cogeneration,- the type of cogeneration technologies as listed in Annex I that are likely to be used to realise the national potential,- the type of separate production of heat and electricity or, where feasible, mechanical energy that high-efficiency cogeneration is likely to substitute,- a division of the potential into modernisation of existing capacity and construction of new capacity.(b) The analysis shall include appropriate mechanisms to assess the cost effectiveness - in terms of primary energy savings - of increasing the share of high-efficiency cogeneration in the national energy mix. The analysis of cost effectiveness shall also take into account national commitments accepted in the context of the climate change commitments accepted by the Community pursuant to the Kyoto Protocol to the United Nations Framework Convention on Climate Change.(c) The analysis of the national cogeneration potential shall specify the potentials in relation to the timeframes 2010, 2015 and 2020 and include, where feasible, appropriate cost estimates for each of the timeframes.