Avis juridique important

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31982L0243

Council Directive 82/243/EEC of 31 March 1982 amending Directive 73/405/EEC on the approximation of the laws of the Member States relating to methods of testing the biodegradability of anionic surfactants

Official Journal L 109 , 22/04/1982 P. 0018 - 0030 Finnish special edition: Chapter 15 Volume 3 P. 0234  Spanish special edition: Chapter 13 Volume 12 P. 0135  Swedish special edition: Chapter 15 Volume 3 P. 0234  Portuguese special edition Chapter 13 Volume 12 P. 0135

COUNCIL DIRECTIVE of 31 March 1982 amending Directive 73/405/EEC on the approximation of the laws of the Member States relating to methods of testing the biodegradability of anionic surfactants (82/243/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Council Directive 73/405/EEC (4) must be adapted to take account of the latest developments in science and technology, thus necessitating:    - the updating of the references relating to the methods listed in Article 2,       - the addition to Article 2 of a further method of measurement which is in use in the United Kingdom,       - the improvement of the "confirmatory test procedure" provided for in the event of a dispute;         Whereas, pursuant to Article 4 of Council Directive 73/404/EEC of 22 November 1973 on the approximation of the laws of the Member States relating to detergents (5), suitable tolerances for the measurement of biodegradability should be determined in order to take due account of the unreliability of test methods which could result in rejection decisions with important economic consequences ; whereas a rejection decision may therefore only be taken where the results obtained with a test method specified in Article 2 of Directive 73/405/EEC reveal a biodegradability of less than 80 %;  Whereas some confusion has arisen as to the scope of Directive 73/405/EEC and it is necessary to make quite clear that the Directive applies only to surfactants used in detergents ; whereas it is also necessary to make quite clear that it is the level of biodegradability of the anionic surfactants contained in a detergent, and not the level of biodegradability of the detergent itself, which is dealt with in Article 2;  Whereas the necessary amendment and amplification of the Annex to Directive 73/405/EEC will be carried out under the procedure provided for in Article 3a thereof,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Directive 73/405/EEC is hereby amended as follows:    1. The following is added to Article 1 : "present in detergents such as those referred to in Article 1 of Directive 73/404/EEC".       2. Articles 2 and 3 are replaced by the following:  "Article 2  Pursuant to Article 4 of Directive 73/404/EEC relating to, detergents, Member States shall prohibit the placing on the market and use on their territory of a detergent if the biodegradability of the anionic surfactants contained therein is less than 80 % determined in accordance with one of the following methods:      - the OECD method, published in the OECD technical report of 11 June 1976 on the "Proposed Method for the Determination of the Biodegradability of Surfactants used in Synthetic Detergents",           - the method in use in Germany, established by the "Verordnung über die Abbaubarkeit  (1) OJ No C 112, 14.5.1981, p. 4. (2) OJ No C 172, 13.7.1981, p. 111. (3) OJ No C 310, 30.11.1981, p. 7. (4) OJ No L 347, 17.12.1973, p. 53. (5) OJ No L 347, 17.12.1973, p. 51.   anionischer und nichtionischer grenzflächenaktiver Stoffe in Wasch- und Reinigungsmitteln" of 30 January 1977, published in the Bundesgesetzblatt, 1977, Part I, page 244, as set out in the Regulation amending that Regulation of 18 June 1980, published in the Bundesgesetzblatt, 1980, Part I, page 706,     - the method in use in France, approved by Decree of 28 December 1977 published in the Journal officiel de la République française of 18 January 1978, pages 514 and 515, and experimental standard T 73-260 of June 1981 published by the "Association française de normalisation" (AFNOR),           - the method in use in the United Kingdom called the "Porous Pot Test" and described in Technical Report No 70 (1978) of the Water Research Centre.             Article 3  Under the procedure laid down in Article 5 (2) of Directive 73/404/EEC, the laboratory opinion on anionic surfactants shall be based on the reference method (confirmatory test procedure) described in the Annex to this Directive.'       3. The following Article shall be inserted:  "Article 3a  The amendments required for adapting the Annex to technical progress shall be adopted in accordance with the procedure laid down in Article 7b of Directive 73/404/EEC. "       4. The Annex is replaced by the Annex to this Directive.          Article 2 Member States shall bring into force the provisions necessary to comply with this Directive within a period of 18 months following its notification and shall forthwith inform the Commission thereof.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 31 March 1982.  For the Council  The President  P. de KEERSMAEKER     ANNEX DETERMINATION OF THE BIODEGRADABILITY OF ANIONIC SURFACTANTS Reference method (confirmatory test) CHAPTER 1     1.1. Definition  Anionic surface active agents in the sense of this Directive are those surface active agents which, after passage through cationic and anionic ion exchangers, are separated by fractional elution and determined as methylene blue active substance (MBAS) according to the analytical procedure described in Chapter 3.       1.2. Equipment needed for measurement  The method of measurement employs the small activated sludge plant shown in Figure 1, and in greater detail in Figure 2.  The equipment consists of a storage vessel A for synthetic sewage, dosing pump B, aeration vessel C, settling vessel D, air-lift pump E to recycle the activated sludge, and vessel F for collecting the treated effluent.  Vessels A and F must be of glass or suitable plastic and hold at least 24 litres. Pump B must provide a constant flow of synthetic sewage to the aeration vessel ; this vessel, during normal operation, contains three litres of mixed liquor. A sintered aeration cube G is suspended in the vessel C at the apex of the cone. The quantity of air blown through the aerator should be monitored by means of a flowmeter H.       1.3. Synthetic sewage  A synthetic sewage is employed for the test.  Dissolve in each litre of tap water : >PIC FILE= "T0035605">   The MBAS is extracted from the product to be tested by the method given in Chapter 2. The synthetic sewage is freshly prepared daily.       1.4. Preparation of samples      1.4.1. Uncompounded surfactants may be examined in the original state. The MBAS content must be determined in order to prepare the synthetic sewage (1.3).           1.4.2. Formulated products are analyzed for MBAS and soap content. They must be subjected to an alcoholic extraction and separation of MBAS (see Chapter 2). The MBAS content of the extract must be known in order to prepare the synthetic sewage.                  1.5. Operation of equipment  Initially fill aeration vessel C and settling vessel D with synthetic sewage. The height of vessel D should be so fixed that the volume contained in aeration vessel C is three litres.   Inoculation is made by introducing 3 ml of a secondary effluent of good quality, freshly collected from a treatment plant dealing with a predominantly domestic sewage. The effluent must be kept under aerobic conditions in the period between sampling and application. Then set aerator G, air lift E and dosing device B in operation. The synthetic sewage must pass through aeration vessel C at the rate of one litre per hour ; this gives a mean retention time of three hours.  The rate of aeration should be so regulated that the contents of vessel C are kept constantly in suspension and the dissolved oxygen content is at least 2 mg/l. Foaming must be prevented by appropriate means. Anti-foaming agents which inhibit the activated sludge or contain MBAS must not be used. Air-lift pump E must be set so that the activated sludge from the settling vessel is continually and regularly recycled to aeration vessel C. Sludge which has accumulated around the top of aeration vessel C, in the base of settling vessel D, or in the circulation circuit must be returned to the circulation at least once each day by brushing or some other appropriate means. When sludge fails to settle, its density may be increased by the addition of 2 ml portions of a 5 % solution of ferric chloride, repeated as necessary.  The effluent from settling vessel D is accumulated in vessel F for 24 hours, following which a sample is taken after thorough mixing. Vessel F must then be carefully cleaned.       1.6. Checking measuring equipment  The MBAS content (in mg/l) of the synthetic sewage is determined immediately before use.  The MBAS content (in mg/l) of the effluent collected over 24 hours in vessel F should be determined analytically by the same method, immediately after collection ; otherwise the samples must be preserved, preferably by freezing. The concentrations must be determined to the nearest 0 71 mg/l MBAS.  As a check on the efficiency of the process the chemical oxygen demand (COD), or the dissolved organic carbon (DOC) of the glass fibre filtered effluent accumulated in vessel F and of the filtered synthetic sewage in vessel A is measured at least twice per week.  The reduction in COD or DOC should level off when a roughly regular daily MBAS biodegradation is obtained, i.e. at the end of the running-in period shown in Figure 3.  The content of dry matter of the suspended solids in the activated sludge in the aeration tank should be determined twice a week (in g/l). If it is more than 2 75 g/l, the excess activated sludge must be discarded.  The test is performed at room temperature ; this should be steady and kept between 292 and 297 K (19-24 °C).       1.7. Calculation of biodegradability  The percentage degradation of MBAS must be calculated every day on the basis of the MBAS content in mg/l of the synthetic sewage and of the corresponding effluent accumulated in vessel F. The degradability figures thus obtained should be presented graphically as in Figure 3.  The degradability of the MBAS should be calculated as the arithmetic mean of the figures obtained over the 21 days which follow the running-in period, during which degradation has been regular and the operation of the plant trouble-free. In any event the duration of the running-in period should not exceed six weeks.  The daily degradation values are calculated to the nearest 0 71 % but the final result is given to the nearest whole number.  In some cases it may be permissible to reduce the frequency of sampling but at least 14 results collected over the 21 days which follow the running-in period should be used in calculating the average.         CHAPTER 2 PRELIMINARY TREATMENT OF PRODUCTS TO BE TESTED     2.1. Preliminary notes      2.1.1. Treatment of samples  The treatment of anionic surface active agents and formulated detergents prior to the determination of biodegradability in the confirmatory test is : >PIC FILE= "T0035606">   The purpose of the alcoholic extraction is to eliminate the insoluble and inorganic ingredients of the commercial product which in some circumstances might upset the biodegradability test.           2.1.2. Ion-exchange procedure  Isolation and separation of anionic surface active agents from soap, non-ionic and cationic surfactants is required for correct biodegradability tests.  This is achieved by an ion-exchange technique using a macro-porous exchange resin and suitable elutants for fractional elution. Thus soap, anionic and non-ionic surfactants may be isolated in one procedure.           2.1.3. Analytical control  After homogenizing, the concentration of anionic surfactants in the synthetic detergent is determined according to the MBAS analytical procedure. The soap content is determined by a suitable analytical method. This analysis of the products is necessary to calculate the quantities required to prepare fractions for the biodegradability test.  Quantitative extraction is not necessary ; however, at least 80 % of the anionic surfactants should be extracted. Usually, 90 % or more is obtained.                  2.2. Principle  From an homogeneous sample (powders, dried pastes and dried liquids) an ethanol extract is obtained which contains the surfactants, soap and other alcohol-soluble constituents of the synthetic detergent sample.  The ethanol extract is evaporated to dryness, dissolved in an isopropanol/water mixture and the solution obtained is passed through a strongly acidic cation exchange/macroporous anion exchange combination heated to 323 K (50 °C). This temperature is necessary to prevent the precipitation of any fatty acids which may be present in acidic media.  Any non-ionic surfactants remain in the effluent.  Soap fatty acids are separated by elution with ethanol containing CO2. The anionic surfactants are then obtained as ammonium salts, by elution with an aqueous isopropanolic solution of ammonium bicarbonate. These ammonium salts are used for the degradation test.  Cationic surfactants which might upset the biodegradability test and the analytical procedure, are eliminated by the cation exchanger placed above the anion exchanger.        2.3. Chemicals and equipment      2.3.1. Deionized water           2.3.2. Ethanol, 95 % (v/v) C2H50H (permissible denaturant : methyl ethyl ketone or methanol)           2.3.3. Isopropanol/water mixture (50/50 v/v):  50 parts by volume isopropanol (CH3CHOH 7CH3) and 50 parts by volume water (2.3.1)           2.3.4. Solution of carbon dioxide in ethanol (approximately 0 71 % CO2) : using a delivery tube with a built-in sinter, pass carbon dioxide (CO2) through the ethanol (2.3.2) for 10 minutes. Use fresh solutions only           2.3.5. Ammonium bicarbonate solution (60/40 v/v) : 0 73 mol NH4HCO3 in 1 000 ml of an isopropanol/water mixture consisting of 60 parts by volume isopropanol and 40 parts by volume water (2.3.1)           2.3.6. Cation exchanger (KAT), strongly acidic, resistant to alcohol (50-100 mesh)           2.3.7. Anion exchanger (AAT), macro-porous, Merck Lewatit MP 7080 (70-150 mesh) or equivalent           2.3.8. Hydrochloric acid, 10 % HCl (w/w)           2.3.9. 2 000 ml round-bottomed flask with ground glass stopper and reflux condenser           2.3.10. 90 mm diameter suction filter (heatable) for filter papers           2.3.11. 2 000 ml filter flask           2.3.12. Exchange columns with heating jacket and tap : inner tube 60 mm in diameter and 450 mm in height (Figure 4)           2.3.13. Water-bath           2.3.14. Vacuum drying oven           2.3.15. Thermostat           2.3.16. Rotary evaporator                  2.4. Preparation of extract and separation and anionic active agents      2.4.1. Preparation of extract  The quantity of surfactants necessary for the biodegradation test is about 50 g MBAS.  Normally, the quantity of product to be extracted will not exceed 1 000 g, but it may be necessary to extract further quantities of sample. For practical reasons, the quantity of product used should in most cases be limited to 5 000 g in preparing extracts for the biodegradation test.  Experience has shown that there are advantages in using a number of small extractions rather than one large extraction. The exchanger quantities specified are designed for a working capacity of 600-700 mmoles of surfactants and soap.           2.4.2. Isolation of alcohol-soluble constituents  Add 250 g of the synthetic detergent to be analyzed to 1 250 ml ethanol, heat the mixture to boiling point and reflux for one hour with stirring. Pass the hot alcoholic solution through a coarse-pored suction filter heated to 323 K (50 °C) and filter rapidly. Wash the flask and suction filter with approximately 200 ml hot ethanol. Collect the filtrate and filter washings in a filter flask.   In the case of pastes or liquid products to be analyzed, make sure that not more than 55 g anionic surfactant and 35 g soap are contained in the sample. Evaporate this weighed sample to dryness. Dissolve the residue in 2 000 ml ethanol and proceed as described above.  In case of powders of low apparent density (Evaporate the ethanolic filtrate to dryness, preferably by means of a rotary evaporator. Repeat the operation if a greater quantity of extract is required. Dissolve the residue in 5 000 ml isopropanol/water mixture.           2.4.3. Preparation of ion-exchange columns  Cation-exchange column  Place 600 ml cation-exchange resin (2.3.6) in a 3 000 ml beaker and cover by adding 2 000 ml hydrochloric acid (2.3.8). Allow to stand for at least two hours, with occasional stirring. Decant the acid and transfer the resin into the column (2.3.12) by means of deionized water. The column should contain a glass wool plug. Wash the column with deionized water at a rate of 10-30 ml/min until the eluate is free of chloride. Displace the water with 2 000 ml isopropanol/water mixture (2.3.3) at a rate of 10-30 ml/min. The exchange column is now ready for operation.  Anion-exchange column  Place 600 ml anion-exchange resin (2.3.7) in a 3 000 ml beaker and cover by adding 2 000 ml deionized water. Allow the resin to swell for at least two hours. Transfer the resin into the column by means of deionized water. The column should contain a glass wool plug.  Wash the column with 0 73 M ammonium bicarbonate solution (2.3.5) until free of chloride. This requires about 5 000 ml solution. Wash again with 2 000 ml deionized water. Displace the water with 2 000 ml isopropanol/water mixture (2.3.3) at a rate of 10-30 ml/min. The exchange column is now in the OH-form and ready for operation.           2.4.4. Ion-exchange procedure  Connect the exchange columns so that the cation-exchange column is placed on top of the anion-exchange column. Heat the exchange columns to 323 K (50 °C) using thermostatic control. Heat 5 000 ml of the solution obtained in item 2.4.2 to 333 K (60 °C) and pass the solution through the exchanger combination at a rate of 20 ml/min. Wash the columns with 1 000 ml hot isopropanol/water mixture (2.3.3).  To obtain the anionic surface active agents (MBAS), disconnect the KAT column. Using 5 000 ml ethanol/CO2 solution (323 K ; 50 °C) (2.3.4), elute the soap fatty acids out of the KAT column. Reject the eluate.  Then elute the MBAS out of the AAT column with 5 000 ml ammonium bicarbonate solution (2.3.5). Evaporate the eluate to dryness on a steam bath or in a rotary evaporator. The residue contains the MBAS (as ammonium salt) and possible non-surfactant anionics which have no detrimental effect on the biodegradation test. Add deionized water to the residue until a definite volume is obtained and determine the MBAS content in an aliquot as in Chapter 3. The solution is used as a standard solution of the anionic synthetic detergents for the biodegradation test. The solution should be kept at a temperature below 278 K (5 °C).           2.4.5. Regeneration of ion-exchange resins  The cation exchanger is rejected after use.  The anion-exchange resin is regenerated by passing an additional quantity of ammonium bicarbonate solution (2.3.5) down the column at a flow rate of approximately 10 ml/min until the eluate is free from anionic surfactants (methylene blue test). The pass 2 000 ml isopropanol/water mixture (2.3.3) down the anion exchanger to wash. The anion exchanger is again ready for operation.                    CHAPTER 3 DETERMINATION OF ANIONIC SURFACE ACTIVE AGENTS IN BIODEGRADABILITY TEST     3.1. Principle  The method is based on the fact that the cationic dye methylene blue forms blue salts with anionic surfactants which can be extracted with chloroform. To eliminate interferences, the extraction is first effected from alkaline solution and the extract is then shaken with acidic methylene blue solution. The absorbance of the separated organic phase is measured photometrically at the wavelength of maximum absorption of 650 nm.       3.2. Reagents and equipment      3.2.1. Buffer solution pH 10:  dissolve 24 g sodium bicarbonate (NaHCO3) AR and 27 g anhydrous sodium carbonate (Na2CO3) AR in deionized water and dilute to 1 000 ml.           3.2.2. Neutral methylene blue solution:  dissolve 0 735 g methylene blue (AR) in deionized water and dilute to 1 000 ml. Prepare the solution at least 24 hours before use. The absorbence of the blank chloroform phase, measured against chloroform, must not exceed 0 7015 per 1 cm of layer thickness at 650 nm.           3.2.3. Acidic methylene blue solution:  dissolve 0 735 g methylene blue (AR) in 500 ml deionized water and mix with 6 75 ml H2SO4 (d = 1 784 g/ml). Dilute to 1 000 ml with deionized water. Prepare the solution at least 24 hours before use. The absorbence of the blank chloroform phase, measured against chloroform, must not exceed 0 7015 per 1 cm of layer thickness at 650 nm.           3.2.4. Chloroform (Trichloromethane) (AR) freshly distilled           3.2.5. Dodecyl benzene sulphonic acid methyl ester           3.2.6. Ethanolic potassium hydroxide solution, KOH 0 71 M           3.2.7. Ethanol pure, C2H50H           3.2.8. Sulphuric acid, H2SO4 0 75 M           3.2.9. Phenolphthalein solution:  dissolve 1 g phenolphthalein in 50 ml ethanol and add 50 ml deionized water while stirring continuously. Filter off any precipitate obtained.           3.2.10. Methanolic hydrochloric acid : 250 ml hydrochloric acid AR and 750 ml methanol           3.2.11. Separating funnel, 250 ml           3.2.12. Graduated flask, 50 ml           3.2.13. Graduated flask, 500 ml           3.2.14. Graduated flask, 1 000 ml           3.2.15. Round-bottomed flask with ground glass stopper and reflux condenser, 250 ml ; boiling granules           3.2.16. pH meter           3.2.17. Photometer for measurements at 650 nm, with 1 to 5 cm cells           3.2.18. Qualitative grade filter paper            3.3. Procedure  The samples for analysis must not be taken through a layer of foam.  After thorough cleaning with water, the equipment used for the analysis must be thoroughly rinsed with methanolic hydrochloric acid (3.2.10) and then with deionized water before using.  Filter the activated sludge plant influent and effluent to be examined immediately on sampling. Discard the first 100 ml of the filtrates.  Place a measured volume of the sample, neutralized if necessary, into a 250 ml separating funnel (3.2.11). The volume of sample should contain between 20 and 150 ¶g of MBAS. At the lower MBAS content, up to 100 ml of sample may be used. When using less than 100 ml, dilute to 100 ml with deionized water. Add to the sample 10 ml of buffer solution (3.2.1), 5 ml of neutral methylene blue solution (3.2.2) and 15 ml of chloroform (3.2.4). Shake the mixture uniformly and not too vigorously for one minute. After phase separation, run the chloroform layer into a second separating funnel containing 110 ml of deionized water and 5 ml of acidic methylene blue solution (3.2.3). Shake the mixture for one minute. Pass the chloroform layer through a cotton-wool filter previously cleaned and wetted with chloroform into a graduated flask (3.2.12).  Extract the alkaline and acid solutions three times, using 10 ml of chloroform for the second and third extractions. Filter the combined chloroform extracts through the same cotton wool filter and dilute to the mark in the 50 ml flask (3.2.12) with chloroform used for rewashing the cotton wool. Measure the absorbance of the chloroform solution with a photometer at 650 nm in 1 to 5 cm cells against chloroform. Run a blank determination through the whole procedure.       3.4. Calibration curve  Prepare a calibration solution from the standard substance dodecyl benzene sulphonic acid methyl ester (tetrapropylene type mol. wt. 340) after saponification into the potassium salt. The MBAS is calculated as sodium dodecyl benzene sulphonate (mol. wt. 348).  From a weighing pipette, weigh 400 to 450 mg of dodecyl benzene sulphonic acid methyl ester (3.2.5) to the nearest 0 71 mg in a round-bottomed flask and add 50 ml of ethanolic potassium hydroxide solution (3.2.6) and some boiling granules. After mounting the reflux condenser, boil for one hour. After cooling, wash the condenser and ground glass joint with about 30 ml of ethanol, and add these washings to the contents of the flask. Titrate the solution with sulphuric acid against phenolphthalein until it becomes colourless. Transfer this solution to a 1 000 ml graduated flask (3.2.14), dilute to the mark with deionized water and mix.  Part of this surfactant stock solution is then further diluted. Withdraw 25 ml, transfer to a 500 ml graduated flask (3.2.13), dilute to the mark with deionized water and mix.  >PIC FILE= "T0035607">   To establish the calibration curve, withdraw 1, 2, 4, 6, 8 ml each of the standard solution and dilute each to 100 ml with deionized water. Then proceed as stated under item 3.3 including a blank determination.       3.5. Calculation of results  The amount of anionic surfactant (MBAS) in the sample is read from the calibration curve (3.4). The MBAS content of the sample is given by: >PIC FILE= "T0035608">   where V = ml volume of the sample used.  Express the results as sodium dodecyl benzene sulphonate (MW 348).       3.6. Expression of results  Express the results as MBAS mg/l to the nearest 0 71.         Figure 1 >PIC FILE= "T0035609">   >PIC FILE= "T0035610">    >PIC FILE= "T0035611">    Figure 4 Heated exchange column (Dimensions in millimetres) >PIC FILE= "T0035612">


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32003L0108

Directive 2003/108/EC of the European Parliament and of the Council of 8 December 2003 amending Directive 2002/96/EC on waste electrical and electronic equipment (WEEE)

Official Journal L 345 , 31/12/2003 P. 0106 - 0107

Directive 2003/108/EC of the European Parliament and of the Councilof 8 December 2003amending Directive 2002/96/EC on waste electrical and electronic equipment (WEEE)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,Having regard to the proposal from the Commission,Having regard to the opinion of the European Economic and Social Committee(1),After consultation of the Committee of the Regions,Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),Whereas:(1) During the adoption procedure concerning Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on waste electrical and electronic equipment (WEEE)(3) concerns were raised about the possible financial implications of the wording of Article 9 of that Directive for producers of the equipment concerned.(2) At the meeting of the Conciliation Committee of 10 October 2002 on that Directive the European Parliament, Council and Commission expressed their intention in a Joint Declaration to examine the issues relating to Article 9 of Directive 2002/96/EC, concerning financing in respect of WEEE from users other than private households, at the earliest opportunity.(3) In accordance with the Joint Declaration, the Commission has examined the financial implications for producers following from the actual wording of Article 9 of Directive 2002/96/EC, and has found that the take-back obligation for WEEE put on the market in the past creates a retroactive liability for which no provision was made and which is likely to expose certain producers to serious economic risks.(4) In order to prevent such risks, the financial responsibility for the collection, treatment, re-use, recovery and recycling of WEEE from users other than private households put on the market before 13 August 2005 should be borne by producers when supplying new products replacing products of equivalent type or fulfilling the same functions. Where such waste is not replaced by new products, the responsibility should be borne by those users. Member States, producers and users should have the possibility to make alternative arrangements.(5) Pursuant to Article 17 of Directive 2002/96/EC, Member States are to bring into force the laws, regulations and administrative provisions necessary to comply with that Directive by 13 August 2004. In order to avoid having to amend Member States' legislation adopted by that date, this Directive should be adopted as soon as possible and implemented in Member States' legislation at the same time as Directive 2002/96/EC.(6) Directive 2002/96/EC should be amended accordingly,HAVE ADOPTED THIS DIRECTIVE:Article 1Article 9 of Directive 2002/96/EC shall be replaced by the following:"Article 9Financing in respect of WEEE from users other than private households1. Member States shall ensure that, by 13 August 2005, the financing of the costs for the collection, treatment, recovery and environmentally sound disposal of WEEE from users other than private households from products put on the market after 13 August 2005 is to be provided for by producers.Member States shall ensure that, by 13 August 2005, for WEEE from products put on the market before 13 August 2005 (historical waste), the financing of the costs of management is as set out in the third and fourth subparagraphs.For historical waste being replaced by new equivalent products or by new products fulfilling the same function, the financing of the costs shall be provided for by producers of those products when supplying them. Member States may, as an alternative, provide that users other than private households also be made, partly or totally, responsible for this financing.For other historical waste, the financing of the costs shall be provided for by the users other than private households.2. Producers and users other than private households may, without prejudice to this Directive, conclude agreements stipulating other financing methods."Article 2Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 13 August 2004. They shall forthwith inform the Commission thereof.When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.Article 3This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 4This Directive is addressed to the Member States.Done at Brussels, 8 December 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentF. Frattini(1) OJ C 234, 30.9.2003, p. 91.(2) Opinion of the European Parliament of 21 October 2003 (not yet published in the Official Journal) and Council decision of 19 November 2003.(3) OJ L 37, 13.2.2003, p. 24.


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31976L0207

Council Directive 76/207/EEC of 9 February 1976 on the implementation of the principle of equal treatment for men and women as regards access to employment, vocational training and promotion, and working conditions

Official Journal L 039 , 14/02/1976 P. 0040 - 0042 Finnish special edition: Chapter 5 Volume 1 P. 0191  Greek special edition: Chapter 05 Volume 2 P. 0070  Swedish special edition: Chapter 5 Volume 1 P. 0191  Spanish special edition: Chapter 05 Volume 2 P. 0070  Portuguese special edition Chapter 05 Volume 2 P. 0070

COUNCIL DIRECTIVE  of 9 February 1976  on the implementation of the principle of equal treatment for men and women as regards access to employment, vocational training and promotion, and working conditions  (76/207/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 the Council, in its resolution of 21 January 1974 concerning a social action programme (3), included among the priorities action for the purpose of achieving equality between men and women as regards access to employment and vocational training and promotion and as regards working conditions, including pay;  Whereas, with regard to pay, the Council adopted on 10 February 1975 Directive 75/117/EEC on the approximation of the laws of the Member States relating to the application of the principle of equal pay for men and women (4);  Whereas Community action to achieve the principle of equal treatment for men and women in respect of access to employment and vocational training and promotion and in respect of other working conditions also appears to be necessary ; whereas, equal treatment for male and female workers constitutes one of the objectives of the Community, in so far as the harmonization of living and working conditions while maintaining their improvement are inter alia to be furthered ; whereas the Treaty does not confer the necessary specific powers for this purpose;  Whereas the definition and progressive implementation of the principle of equal treatment in matters of social security should be ensured by means of subsequent instruments,  HAS ADOPTED THIS DIRECTIVE:    Article 1 1. The purpose of this Directive is to put into effect in the Member States the principle of equal treatment for men and women as regards access to employment, including promotion, and to vocational training and as regards working conditions and, on the conditions referred to in paragraph 2, social security. This principle is herinafter referred to as "the principle of equal treatment."  2. With a view to ensuring the progressive implementation of the principle of equal treatment in matters of social security, the Council, acting on a proposal from the Commission, will adopt provisions defining its substance, its scope and the arrangements for its application.   Article 2 1. For the purposes of the following provisions, the principle of equal treatment shall mean that there shall be no discrimination whatsover on grounds of sex either directly or indirectly by reference in particular to marital or family status.  2. This Directive shall be without prejudice to the right of Member States to exclude from its field of application those occupational activities and, where appropriate, the training leading thereto, for which, by reason of their nature or the context in which they are carried out, the sex of the worker constitutes a determining factor.  3. This Directive shall be without prejudice to provisions concerning the protection of women, particularly as regards pregnancy and maternity.  4. This Directive shall be without prejudice to measures to promote equal opportunity for men and women, in particular by removing existing inequalities which affect women's opportunities in the areas referred to in Article 1 (1).  (1)OJ No C 111, 20.5.1975, p. 14. (2)OJ No C 286, 15.12.1975, p. 8. (3)OJ No C 13, 12.2.1974, p. 1. (4)OJ No L 45, 19.2.1975, p. 19.     Article 3 1. Application of the principle of equal treatment means that there shall be no discrimination whatsover on grounds of sex in the conditions, including selection criteria, for access to all jobs or posts, whatever the sector or branch of activity, and to all levels of the occupational hierarchy.  2. To this end, Member States shall take the measures necessary to ensure that:    (a) any laws, regulations and administrative provisions contrary to the principle of equal treatment shall be abolished;       (b) any provisions contrary to the principle of equal treatment which are included in collective agreements, individual contracts of employment, internal rules of undertakings or in rules governing the independent occupations and professions shall be, or may be declared, null and void or may be amended;       (c) those laws, regulations and administrative provisions contrary to the principle of equal treatment when the concern for protection which originally inspired them is no longer well founded shall be revised ; and that where similar provisions are included in collective agreements labour and management shall be requested to undertake the desired revision.          Article 4 Application of the principle of equal treatment with regard to access to all types and to all levels, of vocational guidance, vocational training, advanced vocational training and retraining, means that Member States shall take all necessary measures to ensure that:    (a) any laws, regulations and administrative provisions contrary to the principle of equal treatment shall be abolished;       (b) any provisions contrary to the principle of equal treatment which are included in collective agreements, individual contracts of employment, internal rules of undertakings or in rules governing the independent occupations and professions shall be, or may be declared, null and void or may be amended;       (c) without prejudice to the freedom granted in certain Member States to certain private training establishments, vocational guidance, vocational training, advanced vocational training and retraining shall be accessible on the basis of the same criteria and at the same levels without any discrimination on grounds of sex.          Article 5 1. Application of the principle of equal treatment with regard to working conditions, including the conditions governing dismissal, means that men and women shall be guaranteed the same conditions without discrimination on grounds of sex.  2. To this end, Member States shall take the measures necessary to ensure that:    (a) any laws, regulations and administrative provisions contrary to the principle of equal treatment shall be abolished;       (b) any provisions contrary to the principle of equal treatment which are included in collective agreements, individual contracts of employment, internal rules of undertakings or in rules governing the independent occupations and professions shall be, or may be declared, null and void or may be amended;       (c) those laws, regulations and administrative provisions contrary to the principle of equal treatment when the concern for protection which originally inspired them is no longer well founded shall be revised ; and that where similar provisions are included in collective agreements labour and management shall be requested to undertake the desired revision.          Article 6 Member States shall introduce into their national legal systems such measures as are necessary to enable all persons who consider themselves wronged by failure to apply to them the principle of equal treatment within the meaning of Articles 3, 4 and 5 to pursue their claims by judicial process after possible recourse to other competent authorities.   Article 7 Member States shall take the necessary measures to protect employees against dismissal by the employer as a reaction to a complaint within the undertaking or to any legal proceedings aimed at enforcing compliance with the principle of equal treatment.   Article 8 Member States shall take care that the provisions adopted pursuant to this Directive, together with the relevant provisions already in force, are brought to the attention of employees by all appropriate means, for example at their place of employment.   Article 9 1. Member States shall put into force the laws, regulations and administrative provisions necessary in order to comply with this Directive within 30 months of its notification and shall immediately inform the Commission thereof.  However, as regards the first part of Article 3 (2) (c) and the first part of Article 5 (2) (c), Member States shall carry out a first examination and if necessary a first revision of the laws, regulations and administrative provisions referred to therein within four years of notification of this Directive.   2. Member States shall periodically assess the occupational activities referred to in Article 2 (2) in order to decide, in the light of social developments, whether there is justification for maintaining the exclusions concerned. They shall notify the Commission of the results of this assessment.  3. Member States shall also communicate to the Commission the texts of laws, regulations and administrative provisions which they adopt in the field covered by this Directive.   Article 10 Within two years following expiry of the 30-month period laid down in the first subparagraph of Article 9 (1), Member States shall forward all necessary information to the Commission to enable it to draw up a report on the application of this Directive for submission to the Council.   Article 11 This Directive is addressed to the Member States.     Done at Brussels, 9 February 1976.  For the Council  The President  G. THORN


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31998L0044

Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions

Official Journal L 213 , 30/07/1998 P. 0013 - 0021

DIRECTIVE 98/44/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 July 1998 on the legal protection of biotechnological inventionsTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the Economic and Social Committee (2),Acting in accordance with the procedure laid down in Article 189b of the Treaty (3),(1) Whereas biotechnology and genetic engineering are playing an increasingly important role in a broad range of industries and the protection of biotechnological inventions will certainly be of fundamental importance for the Community's industrial development;(2) Whereas, in particular in the field of genetic engineering, research and development require a considerable amount of high-risk investment and therefore only adequate legal protection can make them profitable;(3) Whereas effective and harmonised protection throughout the Member States is essential in order to maintain and encourage investment in the field of biotechnology;(4) Whereas following the European Parliament's rejection of the joint text, approved by the Conciliation Committee, for a European Parliament and Council Directive on the legal protection of biotechnological inventions (4), the European Parliament and the Council have determined that the legal protection of biotechnological inventions requires clarification;(5) Whereas differences exist in the legal protection of biotechnological inventions offered by the laws and practices of the different Member States; whereas such differences could create barriers to trade and hence impede the proper functioning of the internal market;(6) Whereas such differences could well become greater as Member States adopt new and different legislation and administrative practices, or whereas national case-law interpreting such legislation develops differently;(7) Whereas uncoordinated development of national laws on the legal protection of biotechnological inventions in the Community could lead to further disincentives to trade, to the detriment of the industrial development of such inventions and of the smooth operation of the internal market;(8) Whereas legal protection of biotechnological inventions does not necessitate the creation of a separate body of law in place of the rules of national patent law; whereas the rules of national patent law remain the essential basis for the legal protection of biotechnological inventions given that they must be adapted or added to in certain specific respects in order to take adequate account of technological developments involving biological material which also fulfil the requirements for patentability;(9) Whereas in certain cases, such as the exclusion from patentability of plant and animal varieties and of essentially biological processes for the production of plants and animals, certain concepts in national laws based upon international patent and plant variety conventions have created uncertainty regarding the protection of biotechnological and certain microbiological inventions; whereas harmonisation is necessary to clarify the said uncertainty;(10) Whereas regard should be had to the potential of the development of biotechnology for the environment and in particular the utility of this technology for the development of methods of cultivation which are less polluting and more economical in their use of ground; whereas the patent system should be used to encourage research into, and the application of, such processes;(11) Whereas the development of biotechnology is important to developing countries, both in the field of health and combating major epidemics and endemic diseases and in that of combating hunger in the world; whereas the patent system should likewise be used to encourage research in these fields; whereas international procedures for the dissemination of such technology in the Third World and to the benefit of the population groups concerned should be promoted;(12) Whereas the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) (5) signed by the European Community and the Member States, has entered into force and provides that patent protection must be guaranteed for products and processes in all areas of technology;(13) Whereas the Community's legal framework for the protection of biotechnological inventions can be limited to laying down certain principles as they apply to the patentability of biological material as such, such principles being intended in particular to determine the difference between inventions and discoveries with regard to the patentability of certain elements of human origin, to the scope of protection conferred by a patent on a biotechnological invention, to the right to use a deposit mechanism in addition to written descriptions and lastly to the option of obtaining non-exclusive compulsory licences in respect of interdependence between plant varieties and inventions, and conversely;(14) Whereas a patent for invention does not authorise the holder to implement that invention, but merely entitles him to prohibit third parties from exploiting it for industrial and commercial purposes; whereas, consequently, substantive patent law cannot serve to replace or render superfluous national, European or international law which may impose restrictions or prohibitions or which concerns the monitoring of research and of the use or commercialisation of its results, notably from the point of view of the requirements of public health, safety, environmental protection, animal welfare, the preservation of genetic diversity and compliance with certain ethical standards;(15) Whereas no prohibition or exclusion exists in national or European patent law (Munich Convention) which precludes a priori the patentability of biological matter;(16) Whereas patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person; whereas it is important to assert the principle that the human body, at any stage in its formation or development, including germ cells, and the simple discovery of one of its elements or one of its products, including the sequence or partial sequence of a human gene, cannot be patented; whereas these principles are in line with the criteria of patentability proper to patent law, whereby a mere discovery cannot be patented;(17) Whereas significant progress in the treatment of diseases has already been made thanks to the existence of medicinal products derived from elements isolated from the human body and/or otherwise produced, such medicinal products resulting from technical processes aimed at obtaining elements similar in structure to those existing naturally in the human body and whereas, consequently, research aimed at obtaining and isolating such elements valuable to medicinal production should be encouraged by means of the patent system;(18) Whereas, since the patent system provides insufficient incentive for encouraging research into and production of biotechnological medicines which are needed to combat rare or 'orphan` diseases, the Community and the Member States have a duty to respond adequately to this problem;(19) Whereas account has been taken of Opinion No 8 of the Group of Advisers on the Ethical Implications of Biotechnology to the European Commission;(20) Whereas, therefore, it should be made clear that an invention based on an element isolated from the human body or otherwise produced by means of a technical process, which is susceptible of industrial application, is not excluded from patentability, even where the structure of that element is identical to that of a natural element, given that the rights conferred by the patent do not extend to the human body and its elements in their natural environment;(21) Whereas such an element isolated from the human body or otherwise produced is not excluded from patentability since it is, for example, the result of technical processes used to identify, purify and classify it and to reproduce it outside the human body, techniques which human beings alone are capable of putting into practice and which nature is incapable of accomplishing by itself;(22) Whereas the discussion on the patentability of sequences or partial sequences of genes is controversial; whereas, according to this Directive, the granting of a patent for inventions which concern such sequences or partial sequences should be subject to the same criteria of patentability as in all other areas of technology: novelty, inventive step and industrial application; whereas the industrial application of a sequence or partial sequence must be disclosed in the patent application as filed;(23) Whereas a mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention;(24) Whereas, in order to comply with the industrial application criterion it is necessary in cases where a sequence or partial sequence of a gene is used to produce a protein or part of a protein, to specify which protein or part of a protein is produced or what function it performs;(25) Whereas, for the purposes of interpreting rights conferred by a patent, when sequences overlap only in parts which are not essential to the invention, each sequence will be considered as an independent sequence in patent law terms;(26) Whereas if an invention is based on biological material of human origin or if it uses such material, where a patent application is filed, the person from whose body the material is taken must have had an opportunity of expressing free and informed consent thereto, in accordance with national law;(27) Whereas if an invention is based on biological material of plant or animal origin or if it uses such material, the patent application should, where appropriate, include information on the geographical origin of such material, if known; whereas this is without prejudice to the processing of patent applications or the validity of rights arising from granted patents;(28) Whereas this Directive does not in any way affect the basis of current patent law, according to which a patent may be granted for any new application of a patented product;(29) Whereas this Directive is without prejudice to the exclusion of plant and animal varieties from patentability; whereas on the other hand inventions which concern plants or animals are patentable provided that the application of the invention is not technically confined to a single plant or animal variety;(30) Whereas the concept 'plant variety` is defined by the legislation protecting new varieties, pursuant to which a variety is defined by its whole genome and therefore possesses individuality and is clearly distinguishable from other varieties;(31) Whereas a plant grouping which is characterised by a particular gene (and not its whole genome) is not covered by the protection of new varieties and is therefore not excluded from patentability even if it comprises new varieties of plants;(32) Whereas, however, if an invention consists only in genetically modifying a particular plant variety, and if a new plant variety is bred, it will still be excluded from patentability even if the genetic modification is the result not of an essentially biological process but of a biotechnological process;(33) Whereas it is necessary to define for the purposes of this Directive when a process for the breeding of plants and animals is essentially biological;(34) Whereas this Directive shall be without prejudice to concepts of invention and discovery, as developed by national, European or international patent law;(35) Whereas this Directive shall be without prejudice to the provisions of national patent law whereby processes for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body are excluded from patentability;(36) Whereas the TRIPs Agreement provides for the possibility that members of the World Trade Organisation may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law;(37) Whereas the principle whereby inventions must be excluded from patentability where their commercial exploitation offends against ordre public or morality must also be stressed in this Directive;(38) Whereas the operative part of this Directive should also include an illustrative list of inventions excluded from patentability so as to provide national courts and patent offices with a general guide to interpreting the reference to ordre public and morality; whereas this list obviously cannot presume to be exhaustive; whereas processes, the use of which offend against human dignity, such as processes to produce chimeras from germ cells or totipotent cells of humans and animals, are obviously also excluded from patentability;(39) Whereas ordre public and morality correspond in particular to ethical or moral principles recognised in a Member State, respect for which is particularly important in the field of biotechnology in view of the potential scope of inventions in this field and their inherent relationship to living matter; whereas such ethical or moral principles supplement the standard legal examinations under patent law regardless of the technical field of the invention;(40) Whereas there is a consensus within the Community that interventions in the human germ line and the cloning of human beings offends against ordre public and morality; whereas it is therefore important to exclude unequivocally from patentability processes for modifying the germ line genetic identity of human beings and processes for cloning human beings;(41) Whereas a process for cloning human beings may be defined as any process, including techniques of embryo splitting, designed to create a human being with the same nuclear genetic information as another living or deceased human being;(42) Whereas, moreover, uses of human embryos for industrial or commercial purposes must also be excluded from patentability; whereas in any case such exclusion does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it;(43) Whereas pursuant to Article F(2) of the Treaty on European Union, the Union is to respect fundamental rights, as guaranteed by the European Convention for the Protection of Human Rights and Fundamental Freedoms signed in Rome on 4 November 1950 and as they result from the constitutional traditions common to the Member States, as general principles of Community law;(44) Whereas the Commission's European Group on Ethics in Science and New Technologies evaluates all ethical aspects of biotechnology; whereas it should be pointed out in this connection that that Group may be consulted only where biotechnology is to be evaluated at the level of basic ethical principles, including where it is consulted on patent law;(45) Whereas processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit in terms of research, prevention, diagnosis or therapy to man or animal, and also animals resulting from such processes, must be excluded from patentability;(46) Whereas, in view of the fact that the function of a patent is to reward the inventor for his creative efforts by granting an exclusive but time-bound right, and thereby encourage inventive activities, the holder of the patent should be entitled to prohibit the use of patented self-reproducing material in situations analogous to those where it would be permitted to prohibit the use of patented, non-self-reproducing products, that is to say the production of the patented product itself;(47) Whereas it is necessary to provide for a first derogation from the rights of the holder of the patent when the propagating material incorporating the protected invention is sold to a farmer for farming purposes by the holder of the patent or with his consent; whereas that initial derogation must authorise the farmer to use the product of his harvest for further multiplication or propagation on his own farm; whereas the extent and the conditions of that derogation must be limited in accordance with the extent and conditions set out in Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights (6);(48) Whereas only the fee envisaged under Community law relating to plant variety rights as a condition for applying the derogation from Community plant variety rights can be required of the farmer;(49) Whereas, however, the holder of the patent may defend his rights against a farmer abusing the derogation or against a breeder who has developed a plant variety incorporating the protected invention if the latter fails to adhere to his commitments;(50) Whereas a second derogation from the rights of the holder of the patent must authorise the farmer to use protected livestock for agricultural purposes;(51) Whereas the extent and the conditions of that second derogation must be determined by national laws, regulations and practices, since there is no Community legislation on animal variety rights;(52) Whereas, in the field of exploitation of new plant characteristics resulting from genetic engineering, guaranteed access must, on payment of a fee, be granted in the form of a compulsory licence where, in relation to the genus or species concerned, the plant variety represents significant technical progress of considerable economic interest compared to the invention claimed in the patent;(53) Whereas, in the field of the use of new plant characteristics resulting from new plant varieties in genetic engineering, guaranteed access must, on payment of a fee, be granted in the form of a compulsory licence where the invention represents significant technical progress of considerable economic interest;(54) Whereas Article 34 of the TRIPs Agreement contains detailed provisions on the burden of proof which is binding on all Member States; whereas, therefore, a provision in this Directive is not necessary;(55) Whereas following Decision 93/626/EEC (7) the Community is party to the Convention on Biological Diversity of 5 June 1992; whereas, in this regard, Member States must give particular weight to Article 3 and Article 8(j), the second sentence of Article 16(2) and Article 16(5) of the Convention when bringing into force the laws, regulations and administrative provisions necessary to comply with this Directive;(56) Whereas the Third Conference of the Parties to the Biodiversity Convention, which took place in November 1996, noted in Decision III/17 that 'further work is required to help develop a common appreciation of the relationship between intellectual property rights and the relevant provisions of the TRIPs Agreement and the Convention on Biological Diversity, in particular on issues relating to technology transfer and conservation and sustainable use of biological diversity and the fair and equitable sharing of benefits arising out of the use of genetic resources, including the protection of knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity`,HAVE ADOPTED THIS DIRECTIVE:CHAPTER I Patentability Article 1 1. Member States shall protect biotechnological inventions under national patent law. They shall, if necessary, adjust their national patent law to take account of the provisions of this Directive.2. This Directive shall be without prejudice to the obligations of the Member States pursuant to international agreements, and in particular the TRIPs Agreement and the Convention on Biological Diversity.Article 2 1. For the purposes of this Directive,(a) 'biological material` means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system;(b) 'microbiological process` means any process involving or performed upon or resulting in microbiological material.2. A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection.3. The concept of 'plant variety` is defined by Article 5 of Regulation (EC) No 2100/94.Article 3 1. For the purposes of this Directive, inventions which are new, which involve an inventive step and which are susceptible of industrial application shall be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used.2. Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature.Article 4 1. The following shall not be patentable:(a) plant and animal varieties;(b) essentially biological processes for the production of plants or animals.2. Inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety.3. Paragraph 1(b) shall be without prejudice to the patentability of inventions which concern a microbiological or other technical process or a product obtained by means of such a process.Article 5 1. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.2. An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.3. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.Article 6 1. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation.2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable:(a) processes for cloning human beings;(b) processes for modifying the germ line genetic identity of human beings;(c) uses of human embryos for industrial or commercial purposes;(d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.Article 7 The Commission's European Group on Ethics in Science and New Technologies evaluates all ethical aspects of biotechnology.CHAPTER II Scope of protection Article 8 1. The protection conferred by a patent on a biological material possessing specific characteristics as a result of the invention shall extend to any biological material derived from that biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics.2. The protection conferred by a patent on a process that enables a biological material to be produced possessing specific characteristics as a result of the invention shall extend to biological material directly obtained through that process and to any other biological material derived from the directly obtained biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics.Article 9 The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material, save as provided in Article 5(1), in which the product in incorporated and in which the genetic information is contained and performs its function.Article 10 The protection referred to in Articles 8 and 9 shall not extend to biological material obtained from the propagation or multiplication of biological material placed on the market in the territory of a Member State by the holder of the patent or with his consent, where the multiplication or propagation necessarily results from the application for which the biological material was marketed, provided that the material obtained is not subsequently used for other propagation or multiplication.Article 11 1. By way of derogation from Articles 8 and 9, the sale or other form of commercialisation of plant propagating material to a farmer by the holder of the patent or with his consent for agricultural use implies authorisation for the farmer to use the product of his harvest for propagation or multiplication by him on his own farm, the extent and conditions of this derogation corresponding to those under Article 14 of Regulation (EC) No 2100/94.2. By way of derogation from Articles 8 and 9, the sale or any other form of commercialisation of breeding stock or other animal reproductive material to a farmer by the holder of the patent or with his consent implies authorisation for the farmer to use the protected livestock for an agricultural purpose. This includes making the animal or other animal reproductive material available for the purposes of pursuing his agricultural activity but not sale within the framework or for the purpose of a commercial reproduction activity.3. The extent and the conditions of the derogation provided for in paragraph 2 shall be determined by national laws, regulations and practices.CHAPTER III Compulsory cross-licensing Article 12 1. Where a breeder cannot acquire or exploit a plant variety right without infringing a prior patent, he may apply for a compulsory licence for non-exclusive use of the invention protected by the patent inasmuch as the licence is necessary for the exploitation of the plant variety to be protected, subject to payment of an appropriate royalty. Member States shall provide that, where such a licence is granted, the holder of the patent will be entitled to a cross-licence on reasonable terms to use the protected variety.2. Where the holder of a patent concerning a biotechnological invention cannot exploit it without infringing a prior plant variety right, he may apply for a compulsory licence for non-exclusive use of the plant variety protected by that right, subject to payment of an appropriate royalty. Member States shall provide that, where such a licence is granted, the holder of the variety right will be entitled to a cross-licence on reasonable terms to use the protected invention.3. Applicants for the licences referred to in paragraphs 1 and 2 must demonstrate that:(a) they have applied unsuccessfully to the holder of the patent or of the plant variety right to obtain a contractual licence;(b) the plant variety or the invention constitutes significant technical progress of considerable economic interest compared with the invention claimed in the patent or the protected plant variety.4. Each Member State shall designate the authority or authorities responsible for granting the licence. Where a licence for a plant variety can be granted only by the Community Plant Variety Office, Article 29 of Regulation (EC) No 2100/94 shall apply.CHAPTER IV Deposit, access and re-deposit of a biological material Article 13 1. Where an invention involves the use of or concerns biological material which is not available to the public and which cannot be described in a patent application in such a manner as to enable the invention to be reproduced by a person skilled in the art, the description shall be considered inadequate for the purposes of patent law unless:(a) the biological material has been deposited no later than the date on which the patent application was filed with a recognised depositary institution. At least the international depositary authorities which acquired this status by virtue of Article 7 of the Budapest Treaty of 28 April 1977 on the international recognition of the deposit of micro-organisms for the purposes of patent procedure, hereinafter referred to as the 'Budapest Treaty`, shall be recognised;(b) the application as filed contains such relevant information as is available to the applicant on the characteristics of the biological material deposited;(c) the patent application states the name of the depository institution and the accession number.2. Access to the deposited biological material shall be provided through the supply of a sample:(a) up to the first publication of the patent application, only to those persons who are authorised under national patent law;(b) between the first publication of the application and the granting of the patent, to anyone requesting it or, if the applicant so requests, only to an independent expert;(c) after the patent has been granted, and notwithstanding revocation or cancellation of the patent, to anyone requesting it.3. The sample shall be supplied only if the person requesting it undertakes, for the term during which the patent is in force:(a) not to make it or any material derived from it available to third parties; and(b) not to use it or any material derived from it except for experimental purposes, unless the applicant for or proprietor of the patent, as applicable, expressly waives such an undertaking.4. At the applicant's request, where an application is refused or withdrawn, access to the deposited material shall be limited to an independent expert for 20 years from the date on which the patent application was filed. In that case, paragraph 3 shall apply.5. The applicant's requests referred to in point (b) of paragraph 2 and in paragraph 4 may only be made up to the date on which the technical preparations for publishing the patent application are deemed to have been completed.Article 14 1. If the biological material deposited in accordance with Article 13 ceases to be available from the recognised depositary institution, a new deposit of the material shall be permitted on the same terms as those laid down in the Budapest Treaty.2. Any new deposit shall be accompanied by a statement signed by the depositor certifying that the newly deposited biological material is the same as that originally deposited.CHAPTER V Final provisions Article 15 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 July 2000. 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 reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive.Article 16 The Commission shall send the European Parliament and the Council:(a) every five years as from the date specified in Article 15(1) a report on any problems encountered with regard to the relationship between this Directive and international agreements on the protection of human rights to which the Member States have acceded;(b) within two years of entry into force of this Directive, a report assessing the implications for basic genetic engineering research of failure to publish, or late publication of, papers on subjects which could be patentable;(c) annually as from the date specified in Article 15(1), a report on the development and implications of patent law in the field of biotechnology and genetic engineering.Article 17 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 18 This Directive is addressed to the Member States.Done at Brussels, 6 July 1998.For the European ParliamentThe PresidentJ. M. GIL-ROBLESFor the CouncilThe PresidentR. EDLINGER(1) OJ C 296, 8.10.1996, p. 4 and OJ C 311, 11.10.1997, p. 12.(2) OJ C 295, 7.10.1996, p. 11.(3) Opinion of the European Parliament of 16 July 1997 (OJ C 286, 22.9.1997, p. 87). Council Common Position of 26 February 1998 (OJ C 110, 8.4.1998, p. 17) and Decision of the European Parliament of 12 May 1998 (OJ C 167, 1.6.1998). Council Decision of 16 June 1998.(4) OJ C 68, 20.3.1995, p. 26.(5) OJ L 336, 23.12.1994, p. 213.(6) OJ L 227, 1.9.1994, p. 1. Regulation as amended by Regulation (EC) No 2506/95 (OJ L 258, 28.10.1995, p. 3).(7) OJ L 309, 31.12.1993, p. 1.


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31988L0599

Council Directive 88/599/EEC of 23 November 1988 on standard checking procedures for the implementation of Regulation (EEC) No 3820/85 on the harmonization of certain social legislation relating to road transport and Regulation (EEC) No 3821/85 on recording equipment in road transport

Official Journal L 325 , 29/11/1988 P. 0055 - 0057 Finnish special edition: Chapter 5 Volume 4 P. 0135  Swedish special edition: Chapter 5 Volume 4 P. 0135

*****COUNCIL  DIRECTIVE  of 23 November 1988  on standard checking procedures for the implementation of Regulation (EEC) No 3820/85 on the harmonization of certain social legislation relating to road transport and Regulation (EEC) No 3821/85 on recording equipment in road transport  (88/599/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 75 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Having regard to the resolution of the Council and the representatives of the Governments of the Member States, meeting within the Council, of 20 December 1985 to improve the implementation of the social regulations in road transport (4),  Whereas Regulations (EEC) No 3820/85 (5) and (EEC) No 3821/85 (6) are important for the creation of a common market for inland transport services;  Whereas proper application of the social regulations in road transport requires uniform and effective checking by Member States;  Whereas it is necessary to introduce minimum requirements to check compliance with the relevant provisions in order to reduce and prevent infringements;  Whereas the Portuguese Republic has only recently introduced checking procedures in road transport and should accordingly be permitted to defer the date of application of this Directive;  Whereas effective and efficient control throughout the Community will require the exchange of information on, and mutual assistance in, the enforcement of the regulations in Member States;  Whereas the exchange of information is compulsory and should take place at regular intervals;  Whereas uniform application of the social regulations on road transport is necessary to avoid distortions of competition between transport undertakings as well as to promote road safety and social progress,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Checks  The objective of this Directive is to lay down minimum conditions for checking the correct and uniform application of Regulations (EEC) No 3820/85 and (EEC) No 3821/85.  Article 2  Checking systems  1. Member States shall organize a system for appropriate and regular checks, both at the roadside and at premises of undertakings, covering each year a large and representative cross-section of drivers, undertakings and vehicles of all transport categories falling within the scope of Regulations (EEC) No 3820/85 and (EEC) No 3821/85.  2. Each Member State shall organize checks in such a way that:  - they cover each year at least 1 % of days worked by drivers of vehicles falling within the scope of Regulations (EEC) No 3820/85 and (EEC) No 3821/85,  - not less than 15 % of the total number of the working days checked shall be checked at the roadside and not less than 25 % at the premises of undertakings.  3. The number of drivers checked at the roadside, the numer of checks at premises of undertakings, the number of working days checked and the number of infringements reported shall be included, inter alia, in the information submitted to the Commission in accordance with Article 16 (2) of Regulation (EEC) No 3820/85.  Article 3  Roadside checks  1. Roadside checks shall be organized in different places at any time, covering a sufficiently extensive part of the road network to make it difficult to avoid checkpoints.  2. The elements of roadside checks are:  - daily driving periods, breaks and daily rest periods and, in the case of clear indications of irregularities, also the record sheets for the preceding days carried on the vehicle in accordance with Article 15 (7) of Regulation (EEC) No 3821/85,  - last weekly rest period, where appropriate,  - correct functioning of the recording equipment (determination of possible misuse of the equipment and/or record sheets) or, where appropriate, presence of the documents referred to in Article 14 (5) of Regulation (EEC) No 3820/85.  3. Roadside checks shall be carried out without discrimination of vehicles and drivers, whether resident or not.  4. To facilitate the authorized inspecting officer's task, they shall be provided with:  - a list of the principal points to be checked,  - a language chart containing the expressions currently used and relating to road transport operations. The Commission will provide the Member States with such a chart.  5. If the findings of a roadside check on the driver of a vehicle registrered in another Member State provide grounds to believe that infringements have been committed which cannot be detected during the check due to lack of necessary data, the competent authorities of the Member States concerned shall assist each other to clarify the situation. In cases where, to this end, the competent Member State carries out a check at the premises of the undertaking, the results of this check shall be communicated to the other State concerned.  Article 4  Checks at the premises of undertakings  1. Checks at premises as provided for in Article 2 (1) shall be planned taking account of past experience of different categories of transport.  Checks shall also be carried out at premsies of undertakings when serious breaches of Regulations (EEC) No 3820/85 and (EEC) No 3821/85 have been detected at the roadside.  2. The elements of checks at the premises of undertakings, in addition to those for roadside checks, are:  - weekly rest periods and driving periods between these rest periods,  - two-weekly limitation of driving hours,  - compensation for reduced daily or weekly rest periods,  - the use of record sheets and/or the organization of drivers' working times.  3. For the purposes laid down in this Article, checks carried out at the premises of the competent authorities, on the basis of relevant documents handed over by undertakings at the request of the said authorities, shall have the same status as checks carried out at the premises of undertakings.  Article 5  Concerted and coordinated checks  1. Member States shall, at least twice yearly, undertake concerted operations to check at the roadside drivers and vehicles falling within the scope of Regulations (EEC) No 3820/85 and (EEC) No 3821/85.  2. Such operations shall, wherever possible, be undertaken at the same time by the enforcement authorities of two or more Member States, each operating on their own territory. Article 6  Exchange of information  1. Information made available bilaterally under Article 17 (3) of Regulation (EEC) No 3820/85 and Article 19 (3) of Regulation (EEC) No 3821/85 shall be exchanged every 12 months beginning six months after notification of this Directive (1) and also upon a specific request by a Member State in individual cases.  2. For this purpose, the competent authorities in each Member State shall use a standard reporting form drawn up by the Commission in agreement with the Member States.  Article 7  1. With the exception of the Portuguese Republic, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 1 January 1989 at the latest.  The Portuguese Republic shall bring the said laws, regulations and administrative provisions into force on 1 January 1990 at the latest.  2. Member States shall communicate to the Commission their laws, regulations and administrative provisions concerning the application of this Directive.  Article 8  This Directive is addressed to the Member States.  Done at Brussels, 23 November 1988.  For the Council  The President  Th. PANGALOS  (1) OJ No C 116, 3. 5. 1988, p. 17.  (2) Opinion delivered on 17 November 1988 (not yet published in the Official Journal).  (3) OJ No C 208, 8. 8. 1988, p. 26.  (4) OJ No C 348, 31. 12. 1985, p. 1.  (5) OJ No L 370, 31. 12. 1985, p. 1.  (6) OJ No L 370, 31. 12. 1985, p. 8.  (1) This Directive was notified to the Member States on 24 November 1988.


Avis juridique important

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31984L0005

Second Council Directive 84/5/EEC of 30 December 1983 on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles

Official Journal L 008 , 11/01/1984 P. 0017 - 0020 Finnish special edition: Chapter 6 Volume 2 P. 0090  Spanish special edition: Chapter 13 Volume 15 P. 0244  Swedish special edition: Chapter 6 Volume 2 P. 0090  Portuguese special edition Chapter 13 Volume 15 P. 0244

*****SECOND  COUNCIL DIRECTIVE  of 30 December 1983  on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles  (84/5/EEC)  THE COUNCIL OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas, by Council Directive 72/166/EEC (4), as amended by Directive 72/430/EEC (5), the Council approximated the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles and to the enforcement of the obligation to insure against such liability;  Whereas Article 3 of Directive 72/166/EEC requires each Member State to take all appropriate measures to ensure that civil liability in respect of the use of vehicles normally based in its territory is covered by insurance; whereas the extent of the liability covered and the terms and conditions of the insurance cover are to be determined on the basis of those measures;  Whereas, however, major disparities continue to exist between the laws of the different Member States concerning the extent of this obligation of insurance cover; whereas these disparities have a direct effect upon the establishment and the operation of the common market;  Whereas, in particular, the extension of the obligation of insurance cover to include liability incurred in respect of damage to property is justified;  Whereas the amounts in respect of which insurance is compulsory must in any event guarantee victims adequate compensation irrespective of the Member State in which the accident occurred;  Whereas it is necessary to make provision for a body to guarantee that the victim will not remain without compensation where the vehicle which caused the accident is uninsured or unidentified; whereas it is important, without amending the provisions applied by the Member States with regard to the subsidiary or non-subsidiary nature of the compensation paid by that body and to the rules applicable with regard to subrogation, to provide that the victim of such an accident should be able to apply directly to that body as a first point of contact; whereas, however, Member States should be given the possibility of applying certain limited exclusions as regards the payment of compensation by that body and of providing that compensation for damage to property caused by an unidentified vehicle may be limited or excluded in view of the danger of fraud;  Whereas it is in the interest of victims that the effects of certain exclusion clauses be limited to the relationship between the insurer and the person responsible  for the accident; whereas, however, in the case of vehicles stolen or obtained by violence, Member States may specify that compensation will be payable by the abovementioned body;  Whereas in order to alleviate the financial burden on that body, Member States may make provision for the application of certain excesses where the body provides compensation for damage to property caused by uninsured vehicles or, where appropriate, vehicles stolen or obtained by violence;  Whereas the members of the family of the insured person, driver or any other person liable should be afforded protection comparable to that of other third parties, in any event in respect of their personal injuries;  Whereas the abolition of checks on insurance is conditional on the granting by the national insurers' bureau of the host country of a guarantee of compensation for damage caused by vehicles normally based in another Member State; whereas the most convenient criterion for determining whether a vehicle is normally based in a given Member State is the bearing of a registration plate of the State; whereas the first indent of Article 1 (4) of Directive 72/166/EEC should therefore be amended to that effect;  Whereas, in view of the situation in certain Member States at the outset as regards on the one hand the minimum amounts, and on the other hand the cover and the excesses applicable by the abovementioned body in respect of damage to property, provision should be made for transitional measures concerning the gradual implementation in those Member States of the provisions of the Directive concerning minimum amounts and compensation for damage to property by that body,  HAS ADOPTED THIS DIRECTIVE:  Article 1  1. The insurance referred to in Article 3 (1) of Directive 72/166/EEC shall cover compulsorily both damage to property and personal injuries.  2. Without prejudice to any higher guarantees which Member States may lay down, each Member State shall require that the amounts for which such insurance is compulsory are at least:  - in the case of personal injury, 350 000 ECU where there is only one victim; where more than one victim is involved in a single claim, this amount shall be multiplied by the number of victims,  - in the case of damage to property 100 000 ECU per claim, whatever the number of victims.  Member States may, in place of the above minimum amounts, provide for a minimum amount of 500 000 ECU for personal injury where more than one victim is involved in a single claim or, in the case of personal injury and damage to property, a minimum overall amount of 600 000 ECU per claim whatever the number of victims or the nature of the damage.  3. For the purposes of this Directive, 'ECU' means the unit of account as defined in Article 1 of Regulation (EEC) No 3180/78 (1). The conversion value in national currency to be adopted for successive four-year periods from 1 January of the first year of each period shall be that obtaining on the last day of the preceding September for which ECU conversion values are available in all the Community currencies. The first period shall begin on 1 January 1984.  4. Each Member State shall set up or authorize a body with the task of providing compensation, at least up to the limits of the insurance obligation for damage to property or personal injuries caused by an unidentified vehicle or a vehicle for which the insurance obligation provided for in paragraph 1 has not been satisfied. This provision shall be without prejudice to the right of the Member States to regard compensation by that body as subsidiary or non-subsidiary and the right to make provision for the settlement of claims between that body and the person or persons responsible for the accident and other insurers or social security bodies required to compensate the victim in respect of the same accident.  The victim may in any case apply directly to the body which, on the basis of information provided at its request by the victim, shall be obliged to give him a reasoned reply regarding the payment of any compensation.  However, Member States may exclude the payment of compensation by that body in respect of persons who voluntarily entered the vehicle which caused the damage or injury when the body can prove that they knew it was uninsured.  Member States may limit or exclude the payment of compensation by that body in the event of damage to property by an unidentified vehicle.  They may also authorize, in the case of damage to property caused by an uninsured vehicle an excess of not more than 500 ECU for which the victim may be responsible.  Furthermore, each Member State shall apply its laws, regulations and administrative provisions to the payment of compensation by this body, without prejudice to any other practice which is more favourable to the victim.  Article 2  1. Each Member State shall take the necessary measures to ensure that any statutory provision or any contractual clause contained in an insurance policy issued in accordance with Article 3 (1) of Directive 72/166/EEC, which excludes from insurance the use or driving of vehicles by:  - persons who do not have express or implied authorization thereto, or  - persons who do not hold a licence permitting them to drive the vehicle concerned, or  - persons who are in breach of the statutory technical requirements concerning the condition and safety of the vehicle concerned,  shall, for the purposes of Article 3 (1) of Directive 72/166/EEC, be deemed to be void in respect of claims by third parties who have been victims of an accident.  However the provision or clause referred to in the first indent may be invoked against persons who voluntarily entered the vehicle which caused the damage or injury, when the insurer can prove that they knew the vehicle was stolen.  Member States shall have the option - in the case of accidents occurring on their territory - of not applying the provision in the first subparagraph if and in so far as the victim may obtain compensation for the damage suffered from a social security body.  2. In the case of vehicles stolen or obtained by violence, Member States may lay down that the body specified in Article 1 (4) will pay compensation instead of the insurer under the conditions set out in paragraph 1 of this Article; where the vehicle is normally based in another Member State, that body can make no claim against any body in that Member State.  The Member States which, in the case of vehicles stolen or obtained by violence, provide that the body referred to in Article 1 (4) shall pay compensation, may fix in respect of damage to property an excess of not more than 250 ECU for which the victim may be responsible.  Article 3  The members of the family of the insured person, driver or any other person who is liable under civil law in the event of an accident, and whose liability is covered by the insurance referred to in Article 1 (1) shall not be excluded from insurance in respect of their personal injuries by virtue of that relationship.  Article 4  The first indent of Article 1 (4) of Directive 72/166/EEC shall be replaced by the following:  '- the territory of the State of which the vehicle bears a registration plate, or'.  Article 5  1. Member States shall amend their national provisions to comply with this Directive not later than 31 December 1987. They shall forthwith inform the Commission thereof.  2. The provisions thus amended shall be applied not later than 31 December 1988.  3. Notwithstanding paragraph 2:  (a) the Hellenic Republic shall have a period until 31 December 1995 in which to increase guarantees to the levels required by Article 1 (2). If it avails itself of this option the guarantee must reach, by reference to the amounts laid down in that Article:  - more than 16 % not later than 31 December 1988,  - 31 % not later than 31 December 1992;  (b) the other Member States shall have a period until 31 December 1990 in which to increase guarantees to the levels required by Article 1 (2). Member States which avail themselves of this option must, by the date indicated in paragraph 1, increase guarantees by at least half the difference between the guarantees in force on 1 January 1984 and the amounts laid down in Article 1 (2).  4. Notwithstanding paragraph 2:  (a) the Italian Republic may provide that the excess laid down in the fifth subparagraph of Article 1 (4) shall be 1 000 ECU until 31 December 1990;  (b) the Hellenic Republic and Ireland may provide that:  - compensation by the body referred to in Article 1 (4) for damage to property shall be excluded until 31 December 1992,  - the excess referred to in the fifth subparagraph of Article 1 (4) and the excess referred to in the second subparagraph of Article 2 (2) shall be 1 500 ECU until 31 December 1995.  Article 6  1. Not later than 31 December 1989 the Commission shall present to the Council a report on the situation in the Member States benefiting from the transi tional measures provided for in Article 5 (3) (a) and (4) (b) and shall, where appropriate, submit proposals to review these measures in the light of developments.  2. Not later than 31 December 1993 the Commission shall present to the Council a progress report on the implementation of this Directive and shall, where appropriate, submit proposals in particular as regards adjustment of the amounts laid down in Article 1 (2) and (4).  Article 7  This Directive is addressed to the Member States.  Done at Brussels, 30 December 1983.  For the Council  The President  G. VARFIS  (1) OJ No C 214, 21. 8. 1980, p. 9 and OJ No C 78, 30. 3. 1982, p. 17,  (2) OJ No C 287, 9. 11. 1981, p. 44.  (3) OJ No C 138, 9. 6. 1981, p. 15.  (4) OJ No L 103, 2. 5. 1972, p. 2.  (5) OJ No L 291, 28. 12. 1972, p. 162.  (1) OJ No L 379, 30. 12. 1978, p. 1.