Avis juridique important

|

31979L1071

Council Directive 79/1071/EEC of 6 December 1979 amending Directive 76/308/EEC on mutual assistance for the recovery of claims resulting from operations forming part of the system of financing of the European Agricultural Guidance and Guarantee Fund, and of agricultural levies and customs duties

Official Journal L 331 , 27/12/1979 P. 0010 - 0010 Finnish special edition: Chapter 2 Volume 2 P. 0158  Greek special edition: Chapter 02 Volume 8 P. 0035  Swedish special edition: Chapter 2 Volume 2 P. 0158  Spanish special edition: Chapter 02 Volume 6 P. 0120  Portuguese special edition Chapter 02 Volume 6 P. 0120

COUNCIL DIRECTIVE  of 6 December 1979  amending Directive 76/308/EEC on mutual assistance for the recovery of claims resulting from operations forming part of the system of financing the European Agricultural Guidance and Guarantee Fund, and of agricultural levies and customs duties  (79/1071/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 99 and 100 thereof,  Having regard to the proposal from the Commission,  Having regard to the opinion of the European Parliament (1),  Having regard to the opinion of the Economic and Social Committee (2),  Whereas it is not at present possible, in principle, to enforce in one Member State a claim for recovery in respect of value added tax substantiated by a document drawn up by the authorities of another Member State;  Whereas the fact that national provisions relating to recovery of value added tax are applicable only within national territories is in itself an obstacle to the establishment and functioning of the common market ; whereas it is therefore necessary to adopt common rules on mutual assistance between Member States for the purpose of recovery ; whereas those rules must also apply to the recovery of interest and costs incidental to claims;  Whereas the Council has, by Directive 76/308/EEC (3), adopted common rules for the recovery of claims resulting from operations forming part of the system of financing the European Agricultural Guidance and  Guarantee Fund, and of agricultural levies and customs duties;  Whereas it is possible to have recourse to the same rules for tax purposes ; whereas it is sufficient, therefore, to extend the scope of Directive 76/308/EEC,  HAS ADOPTED THIS DIRECTIVE:    Article 1 The title of Council Directive 76/308/EEC shall be amended to read as follows:  "Council Directive of 15 March 1976 on mutual assistance for the recovery of claims resulting from operations forming part of the system of financing the European Agricultural Guidance and Guarantee Fund, and of agricultural levies and customs duties, and in respect of value added tax."   Article 2 Article 2 of Directive 76/308/EEC shall be amended as follows:    (a) letter "d" shall be repaced by "e";       (b) the following point "(d)" shall be inserted after point "(c)":  "(d) value added tax."          Article 3 Member States shall take the measures necessary to comply with this Directive by 1 January 1981.   Article 4 This Directive is addressed to the Member States.     Done at Brussels, 6 December 1979.  For the Council  The President  L. PRETI  (1)OJ No C 57, 7.3.1977, p. 62. (2)OJ No C 56, 7.3.1977, p. 79. (3)OJ No L 73, 19.3.1976, p. 18.


Avis juridique important

|

31981L0432

Commission Directive 81/432/EEC of 29 April 1981 laying down the Community method of analysis for the official control of vinyl chloride released by materials and articles into foodstuffs

Official Journal L 167 , 24/06/1981 P. 0006 - 0011 Finnish special edition: Chapter 13 Volume 11 P. 0140  Spanish special edition: Chapter 13 Volume 11 P. 0203  Swedish special edition: Chapter 13 Volume 11 P. 0140  Portuguese special edition Chapter 13 Volume 11 P. 0203

COMMISSION DIRECTIVE of 29 April 1981 laying down the Community method of analysis for the official control of vinyl chloride released by materials and articles into foodstuffs (81/432/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 78/142/EEC of 30 January 1978 on the approximation of the laws of the Member States relating to materials and articles which contain vinyl chloride monomer and are intended to come into contact with foodstuffs (1), and in particular Article 3 thereof,  Whereas Article 2 of Directive 78/142/EEC lays down that materials and articles must not pass on to the foodstuffs which are in, or have been brought into, contact with such materials and articles any vinyl chloride detectable by a method having a limit of detection of 0 701 mg/kg, and Article 3 that this limit must be controlled by a Community method of analysis;  Whereas, on the basis of a series of inter-laboratory collaborative trials, the method described in the Annex has proved to be sufficiently accurate and reproducible to be adopted as a Community method;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,  HAS ADOPTED THIS DIRECTIVE:    Article 1 The analysis necessary for official control of vinyl chloride released by materials and articles into foodstuffs shall be performed according to the method described in the Annex hereto.   Article 2 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 October 1982. They shall forthwith inform the Commission thereof.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 29 April 1981.  For the Commission  Karl-Heinz NARJES  Member of the Commission   (1) OJ No L 44, 15.2.1978, p. 15.     ANNEX DETERMINATION OF VINYL CHLORIDE RELEASED BY MATERIALS AND ARTICLES INTO FOODSTUFFS     1. SCOPE AND FIELD OF APPLICATION  The method determines the level of vinyl chloride in foodstuffs.       2. PRINCIPLE  The level of vinyl chloride (VC) in foodstuffs is determined by means of gas-chromatography using the "headspace" method.       3. REAGENTS      3.1. Vinyl chloride (VC), of purity greater than 99 75 % (v/v).           3.2. N, N-dimethylacetamide (DMA), free from any impurity with the same retention time as VC or as the internal standard (3.3) under the conditions of the test.           3.3. Diethyl ether or cis-2-butene, in DMA (3.2) as the internal standard solution. These internal standards must not contain any impurity with the same retention time as VC, under the conditions of the test.           3.4. Distilled water or demineralized water of equivalent purity.                  4. APPARATUS  NB:  An instrument or piece of apparatus is mentioned only if it is special, or made to particular specifications. Usual laboratory apparatus is assumed to be available.      4.1. Gas-chromatograph fitted with automatic headspace sampler or with facilities for manual sample injection.           4.2. Flame ionization detector or other detectors mentioned in point 7.           4.3. Gas-chromatographic column  The column must permit the separation of the peaks of air, of VC and of the internal standard, if used.  Furthermore, the combined 4.2 and 4.3 system must allow the signal obtained with a solution containing 0 7005 mg VC/litre DMA or 0 7005 mg VC/kg DMA to be equal to at least five times the background noise.           4.4. Sample phials or flasks fitted with silicon or butyl rubber septa  When using manual sampling techniques, the taking of a sample from the headspace with a syringe may cause a partial vacuum to form inside the phial or flask. Hence, for manual techniques where the phials are not pressurized before the sample is taken, the use of large phials is recommended.           4.5. Micro-syringes.           4.6. Gas-tight syringes for manual headspace sampling.           4.7. Analytical balance accurate to 0 71 mg.                  5. PROCEDURE  CAUTION : VC is a hazardous substance and a gas at ambient temperature therefore, the preparation of solutions should be carried out in a well-ventilated fume cupboard.  NB:  Take all the necessary precautions to ensure that no VC or DMA is lost.  When employing manual sampling techniques, an internal standard (3.3) should be used.  When using an internal standard, the same solution must be utilized throughout the procedure.       5.1. Preparation of standard VC solution (solution A)        5.1.1. Concentrated standard VC solution at approximately 2 000 mg/kg  Accurately weigh to the nearest 0 71 mg a suitable glass vessel and place in it a quantity (e.g. 50 ml) of DMA (3.2). Re-weigh. Add to the DMA a quantity (e.g. 0 71 g) of VC (3.1) in liquid or gas form, injecting it slowly onto the DMA. The VC may also be added by bubbling it into the DMA, provided that a device is used which will prevent loss of DMA. Reweigh to the nearest 0 71 mg. Wait two hours to allow equilibrium to be attained. If an internal standard is to be employed, add internal standard so that the concentration of the internal standard in the concentrated standard VC solution is the same as in the internal standard solution prepared under point 3.3. Keep the standard solution in a refrigerator.               5.1.2. Preparation of dilute standard VC solution  Take a weighed amount of concentrated standard solution of VC (5.1.1) and dilute, to a known volume or a known weight, with DMA (3.2) or with internal standard solution (3.3). The concentration of the resultant dilute standard solution (solution A) is expressed as mg/litre or mg/kg respectively.               5.1.3. Preparation of the response curve with solution A  NB:  The curve must comprise at least seven pairs of points.  The repeatability of the responses (1) must be lower than 0 7002 mg VC/litre or kg of DMA.  The curve must be calculated from these points by the least squares technique, i.e., the regression line must be calculated using the following equation: >PIC FILE= "T0019847">   (1) See recommendation ISO DIS 5725 : 1977.  >PIC FILE= "T0019848">   Prepare two series of at least seven phials (4.4). Add to each phial volumes of dilute standard VC solution (5.1.2) and DMA (3.2) or internal standard solution in DMA (3.3) such that the final VC concentration of the duplicate solutions will be approximately equal to 0, 0 7005, 0 7010, 0 7020, 0 7030, 0 7040, 0 7050, etc., mg/litre or mg/kg of DMA and that each phial contains the same total volume of solution. The quantity of dilute standard VC solution (5.1.2) must be such that the ratio between the total volume (¶l) of added VC solution and quantity (g or ml) of DMA, or internal standard solution (3.3) does not exceed five. Seal the phials and proceed as described under points 5.4.2, 5.4.3 and 5.4.5. Construct a graph in which the ordinate values show the areas (or heights) of the VC peaks of the duplicate solutions, or the ratio of these areas (or heights) to those of the relevant internal standard peaks, and the abscissa values show the VC concentrations of the duplicate solutions.                   5.2. Validation of preparation of standard solutions obtained in point 5.1        5.2.1. Preparation of a second standard VC solution (solution B)  Repeat the procedure described under points 5.1.1 and 5.1.2 to obtain a second dilute standard solution with, in this case, a concentration approximately equal to 0 702 mg VC : 1, or 0 702 mg VC/kg of DMA or internal standard solution. Add this solution to two phials (4.4). Seal the phials and proceed as described under points 5.4.2, 5.4.3 and 5.4.5.               5.2.2. Validation of solution A  If the average of two gas-chromatographic determinations relating to the solution B (5.2.1) does not differ by more than 5 % from the corresponding point of the response curve obtained in point 5.1.3, the solution A is validated. If the difference is greater than 5 %, reject all the solutions obtained in points 5.1 and 5.2 and repeat the procedure from the beginning.                          5.3. Preparation of the "addition" curve  NB:  The curve must comprise at least seven pairs of points.  The curve must be calculated from these points by the least squares technique (5.1.3, third indent). >PIC FILE= "T0019849">         5.3.1. Preparation of sample  The sample of foodstuff to be analyzed must be representative of the foodstuff presented for analysis. The foodstuff must, therefore, be mixed or reduced to small pieces and mixed before the sample is taken.                5.3.2. Procedure  Prepare two series of at least seven phials (4.4). Add to each phial a quantity, not less than 5 g, of sample obtained from the foodstuff under investigation (5.3.1). Ensure that an equal quantity is added to each phial. Close the phial immediately. Add to each phial for each gram of sample 1 ml, preferably of distilled water, or demineralized water of at least equivalent purity, or an appropriate solvent if necessary. (Note : for homogeneous foodstuffs, addition of distilled of demineralized water is not necessary.) Add to each phial volumes of dilute standard VC solution (5.1.2), containing the internal standard (3.3), if considered useful, such that concentrations of VC added to the phials equal to 0, 0 7005, 0 7010, 0 7020, 0 7030, 0 7040 and 0 7050, etc., mg/kg of foodstuffs. Ensure that the total volume of DMA or DMA containing internal standard (3.3) in each phial is the same. The quantity of dilute standard VC solution (5.1.2) and additional DMA where used, must be such that the ratio between the total volume (¶l) of these solutions and the quantity (g) of foodstuff contained in the phial is as low as possible but not more than five and is the same in all phials. Seal the phials and proceed as described under point 5.4.                          5.4. Gas-chromatographic determinations        5.4.1. Agitate the phials avoiding contact between the contained liquid and the septum (4.4) to obtain a solution or a suspension of the samples of foodstuff as homogeneous as possible.               5.4.2. Put all the sealed phials (5.2 and 5.3) in a waterbath for two hours at 60 ± 1 ºC to allow equilibrium to be attained. Agitate again, if necessary.               5.4.3. Take a sample from the headspace in the phial. When utilizing manual sampling techniques care must be exercized in obtaining a reproducible sample (4.4) in particular the syringe must be pre-warmed to the temperature of the sample. Measure the area (or height) of the peaks relating to the VC and internal standard, if used.               5.4.4. Construct a graph in which the ordinate value shows the areas (or heights) of the VC peaks or the ratio of the areas (or heights) of VC peaks to the areas (or heights) of the internal standard peaks and the abscissa values show the quantities of VC added (mg) relating to the quantities of the sample of foodstuff weighed in each phial (kg). Measure the abscissa intercept from the graph. The value so obtained is the concentration of VC in the sample of the foodstuff under investigation.               5.4.5. Remove from the column (4.3) excess DMA using an appropriate method as soon as peaks of DMA appear on the chromatogram.                                 6. RESULTS  The VC released by materials and articles into the foodstuff under investigation expressed in mg/kg shall be defined as the average of the two determinations (5.4) provided that the repeatability criterion in point 8 is satisfied.       7. CONFIRMATION OF THE VC  In cases where the VC released by materials and articles into the foodstuffs as calculated under point 6, exceeds the criterion in Article 2 (2) of Council Directive 78/142/EEC of 30 January 1978, the values obtained in each of the two determinations (5.4) must be confirmed in one of three ways:      (i) by using at least one other column (4.3) having a stationary phase of different polarity. This procedure should continue until a chromatogram is obtained with no evidence of overlap of the VC and/or internal standard peaks with constituents of the sample of foodstuff,           (ii) by using other detectors, e.g. the micro-electrolytic conductivity detector (1),           (iii) by using mass spectrometry ; in this case, if molecular ions with parent masses (m/e) of 62 and 64 are found in the ratio of 3 : 1 it may be regarded with high probability as (1) See Journal of Chromatographic Science (volume 12), March 1974, page 152.  confirming the presence of VC. In case of doubt the total mass spectrum must be checked.               8. REPEATABILITY  The difference between the results of two determinations (5.4) carried out simultaneously or in rapid succession on the same sample, by the same analyst, under the same conditions, must not exceed 0 7003 mg VC/kg of foodstuff.


Avis juridique important

|

32003L0115

Directive 2003/115/EC of the European Parliament and of the Council of 22 December 2003 amending Directive 94/35/EC on sweeteners for use in foodstuffs

Official Journal L 024 , 29/01/2004 P. 0065 - 0071

Directive 2003/115/EC of the European Parliament and of the Councilof 22 December 2003amending Directive 94/35/EC on sweeteners for use in foodstuffsTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Economic and Social Committee(2),After consultation of the Scientific Committee on Food, pursuant to Article 6 of Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption(3),Acting in accordance with the procedure laid down in Article 251 of the Treaty(4),Whereas:(1) Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on sweeteners for use in foodstuffs(5) lays down a list of sweeteners that may be used in the Community and their conditions of use.(2) Since 1996, two new sweeteners, sucralose and the salt of aspartame and acesulfame, have been found acceptable for use in food by the Scientific Committee on Food.(3) The opinion of the Scientific Committee on Food on cyclamic acid and its sodium and calcium salts (which led to the establishment of a new acceptable daily intake (ADI)) and recent studies on the intake of cyclamates lead to a reduction of the maximum usable doses of cyclamic acid and its sodium and calcium salts.(4) The designation of certain food categories in Directive 94/35/EC should be adapted to take into account Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements(6) and of specific directives adopted for some groups of foodstuffs listed in Annex I to Council Directive 89/398/EEC(7).(5) The use of the food additives concerned complies with the general criteria laid down in Annex II to Directive 89/107/EEC.(6) Articles 53 and 54 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(8) establish procedures for taking emergency measures in relation to food of Community origin or imported from a third country. They allow the Commission to adopt such measures in situations where food is likely to constitute a serious risk to human health, animal health or the environment and where such risk cannot be contained satisfactorily by measures taken by the Member State(s) concerned.(7) The measures necessary for implementation of Directive 94/35/EC should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(9).(8) Directive 94/35/EC should therefore be amended accordingly,HAVE ADOPTED THIS DIRECTIVE:Article 1Directive 94/35/EC is hereby amended as follows:1. Article 4 shall be replaced by the following:"Article 4It may be decided in accordance with the procedure laid down in Article 7:- where there are differences of opinion as to whether sweeteners can be used in a given foodstuff under the terms of this Directive, whether that foodstuff is to be considered as belonging to one of the categories listed in the third column of the Annex, and- whether a food additive listed in the Annex and authorised at 'quantum satis' is used in accordance with the criteria referred to in Article 2.";2. a third indent shall be added to Article 5(2):"- salt of aspartame and acesulfame: 'contains a source of phenylalanine'.";3. Article 7 shall be replaced by the following:"Article 71. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health set up pursuant to Article 58 of Regulation (EC) No 178/2002(10), hereinafter referred to as 'the Committee'.2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC(11) shall apply, having regard to the provisions of Article 8 thereof.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.3. The Committee shall adopt its rules of procedure."4. the Annex shall be amended in accordance with the Annex to this Directive.Article 2By 29 January 2006 at the latest, the Commission shall submit a report to the European Parliament and the Council outlining the progress made in the re-evaluations of additives under way and setting out a provisional calendar for future re-evaluations, especially those for sucralose and salt of aspartame-acesulfame. These re-evaluations shall be carried out on the basis of consumer data supplied by the Member States and shall take account of the effects of additives on vulnerable population groups.Article 3Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive in order to:- authorise trade in and use of products conforming with this Directive by 29 January 2005 at the latest,- prohibit trade in and use of products not conforming with this Directive by 29 July 2005 at the latest; however, products placed on the market before that date which do not comply with this Directive may be marketed until 29 January 2006.They shall forthwith inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.Article 4This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 5This Directive is addressed to the Member States.Done at Brussels, 22 December 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentA. Matteoli(1) OJ C 262 E of 29.10.2002, p. 429.(2) OJ C 85, 8.4.2003, p. 34.(3) OJ L 40, 11.2.1989, p. 27. Directive as amended by Directive 94/34/EC of the European Parliament and of the Council (OJ L 237, 10.9.1994, p. 1).(4) Opinion of the European Parliament of 10 April 2003 (not yet published in the Official Journal), Council Common Position of 25 June 2003 (OJ C 277 E, 18.11.2003, p. 1) and position of the European Parliament of 22 October 2003 (not yet published in the Official Journal).(5) OJ L 237, 10.9.1994, p. 3. Directive as amended by Directive 96/83/EC (OJ L 48, 19.2.1997, p. 16).(6) OJ L 183, 12.7.2002, p. 51.(7) OJ L 186, 30.6.1989, p. 27. Directive as last amended by Directive 1999/41/EC of the European Parliament and of the Council (OJ L 172, 8.7.1999, p. 38).(8) OJ L 31, 1.2.2002, p. 1.(9) OJ L 184, 17.7.1999, p. 23.(10) OJ L 31, 1.2.2002, p. 1.(11) Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ L 184, 17.7.1999, p. 23).ANNEXThe Annex to Directive 94/35/EC is hereby amended as follows:1. in the third column of the tables the following categories of foodstuffs shall be renamed:(a) instead of "Complete formulae for weight control intended to replace total daily food intake or an individual meal" to read "Foods intended for use in energy-restricted diets for weight reduction as referred to in Directive 96/8/EC (*)";(b) instead of "Complete formulae and nutritional supplements for use under medical supervision" to read "Dietary foods for special medical purposes as defined in Directive 1999/21/EC (**)";(c) instead of "Liquid food supplements/dietary integrators" to read "Food supplements as defined in Directive 2002/46/EC (***) supplied in a liquid form";(d) instead of "Solid food supplements/dietary integrators" to read "Food supplements as defined in Directive 2002/46/EC supplied in a solid form";(e) instead of "Food supplements/dietary integrators based on vitamins and/or mineral elements, syrup-type or chewable" to read "Food supplements as defined in Directive 2002/46/EC, based on vitamins and/or mineral elements and supplied in a syrup-type or chewable form";2. the following footnotes shall be added after the tables:"(*) Commission Directive 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets for weight reduction (OJ L 55, 6.3.1996, p. 22).(**) Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (OJ L 91, 7.4.1999, p. 29).(***) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51)."3. for E 951 "Aspartame" the following category shall be added under "Confectionery":">TABLE>"4. for E 952 cyclamic acid and its sodium and calcium salts:(a) for the following categories of foodstuffs, the maximum usable dose of "400 mg/l" shall be replaced by "250 mg/l":- Water-based flavoured drinks, energy-reduced or with no added sugar;- Milk- and milk derivative-based or fruit-juice-based drinks, energy-reduced or with no added sugar;(b) the following categories of foodstuffs and maximum usable doses shall be deleted:">TABLE>"5. the following tables shall be added:">TABLE>"


Avis juridique important

|

31981L0334

Commission Directive 81/334/EEC of 13 April 1981 adapting to technical progress Council Directive 70/157/EEC on the approximation of the laws of the Member States relating to the permissible sound level and the exhaust system of motor vehicles

Official Journal L 131 , 18/05/1981 P. 0006 - 0027 Finnish special edition: Chapter 13 Volume 11 P. 0118  Spanish special edition: Chapter 13 Volume 11 P. 0179  Swedish special edition: Chapter 13 Volume 11 P. 0118  Portuguese special edition Chapter 13 Volume 11 P. 0179

COMMISSION DIRECTIVE of 13 April 1981 adapting to technical progress Council Directive 70/157/EEC on the approximation of the laws of the Member States relating to the permissible sound level and the exhaust system of motor vehicles (81/334/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), as last amended by Directive 80/1267/EEC (2), and in particular Article 13 thereof,  Having regard to Council Directive 70/157/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the permissible sound level and the exhaust system of motor vehicles (3), as last amended by Directive 77/212/EEC (4), and in particular Article 3 thereof,  Whereas, as a result of experience gained in this field, and bearing in mind the present state of the art, it is now possible to amend the requirements relating to the method of measuring the noise of moving and stationary vehicles in order to bring them more into line with real operating conditions;  Whereas the provisions of Article 3 of Directive 70/157/EEC exclude the modification of the limit values from the procedure of adaptation to technical progress ; whereas it is appropriate to insert, for information, in this Directive the limit values such as they appear in Directive 77/212/EEC ; whereas, however, it is planned to lower those values, in due time, in conformity with the procedure provided for this matter;  Whereas both exhaust systems and certain components thereof are marketed separately as spare parts ; whereas, in so far as they can also be checked before being fitted to a vehicle, their free movement could be facilitated by the establishment of an EEC type-approval procedure in respect of these separate systems considered as separate technical units within the meaning of Article 9a inserted into Directive 70/156/EEC by Directive 78/315/EEC (5);  Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives aimed at the Removal of Technical Barriers to Trade in the Motor Vehicles Sector,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Directive 70/157/EEC is hereby amended as follows:    1. Article 2 shall be replaced by the following:  "Article 2  No Member State may, on grounds relating to the permissible sound level and the exhaust system, refuse to grant EEC or national type-approval in respect of a type of motor vehicle or type of exhaust system or component of such a system regarded as a separate technical unit,      - if the vehicle satisfies the requirements of Annex I as regards the sound level and exhaust system,           - if the exhaust system or any component thereof, considered as a separate technical unit within the meaning of Article 9a of Directive 70/156/EEC satisfies the requirements of Annex II."                  2. Article 2a shall be replaced by the following:  "Article 2a 1. No Member State may, on grounds relating to the permissible sound level and the exhaust system,  (1) OJ No L 42, 23.2.1970, p. 1. (2) OJ No L 375, 31.12.1980, p. 34. (3) OJ No L 42, 23.2.1970, p. 16. (4) OJ No L 66, 12.3.1977, p. 33. (5) OJ No L 81, 28.3.1978, p. 1.  refuse or prohibit the sale, registration, entry into service or use of any vehicle in which the sound level and the exhaust system satisfy the requirements of Annex I.  2. No Member State may, on grounds relating to the permissible sound level and the exhaust system, prohibit the placing on the market of an exhaust system or any component thereof considered as a separate technical unit within the meaning of Article 9a of Directive 70/156/EEC if, within the meaning of Article 2, it is of a type in respect of which a type-approval has been granted."       3. In Article 3, "items I.1 and I.4.1.4" shall be replaced by "items 5.2.2.1 and 5.2.2.5 of Annex I".       4. The Annex shall be replaced by Annexes I, II, III and IV to this Directive.          Article 2 1. With effect from 1 January 1982, no Member State may, on grounds relating to the permissible sound level and the exhaust system:    - refuse to grant EEC type-approval, to issue the document referred to in the last indent of Article 10 (1) of Directive 70/156/EEC or to grant national type-approval, in respect of a type of motor vehicle, or       - prohibit the entry into service of vehicles,         if the sound level and the exhaust system of this type of vehicle, or the vehicles concerned, comply with the provisions of Directive 70/157/EEC, as amended by the present Directive.  2. With effect from 1 October 1984, a Member State:    - shall no longer issue the document referred to in the last indent of Article 10 (1) of Directive 70/156/EEC in respect of a type of motor vehicle in which the sound level and exhaust system do not comply with the provisions of Directive 70/157/EEC, as amended by the present Directive,       - may refuse to grant national type-approval in respect of a type of motor vehicle in which the sound level and exhaust system do not comply with the provisions of Directive 70/157/EEC, as amended by the present Directive.         3. With effect from 1 October 1985, Member States may prohibit the entry into service of vehicles in which the sound level and exhaust system do not comply with the provisions of Directive 70/157/EEC, as amended by the present Directive.   Article 3 By 1 January 1982, Member States shall apply the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.   Article 4 This Directive is addressed to the Member States.     Done at Brussels, 13 April 1981.  For the Commission  Karl-Heinz NARJES  Member of the Commission     ANNEX I  EEC TYPE-APPROVAL IN RESPECT OF THE SOUND LEVEL OF A TYPE OF MOTOR VEHICLES    1. DEFINITIONS      1.1. Type of vehicle for the purposes of EEC type-approval as regards its sound level  For the purposes of this Directive, "type of vehicle" means vehicles which do not differ essentially as regards the following parts:        1.1.1. the shape or materials of the bodywork (particularly the engine compartment and its soundproofing);               1.1.2. the length and width of the vehicle;               1.1.3. the type of engine (two- or four-stroke, reciprocating or rotary piston, number and capacity of cylinders, number and type of carburettors or injection systems, arrangement of valves, rated maximum power and corresponding engine speed (S));               1.1.4. the transmission system, particularly the number of gears and their ratios;               1.1.5. the number, type and arrangement of the exhaust systems;               1.1.6. the number, type and arrangement of the intake systems.                          1.2. Exhaust and intake systems        1.2.1. "Exhaust system" means a complete set of parts necessary to reduce the noise produced by the vehicle's engine exhaust.               1.2.2. "Intake system" means a complete set of parts necessary to reduce the noise produced by the vehicle's engine intake.               1.2.3. For the purposes of this Directive, these systems do not include the manifolds.                          1.3. Different types of exhaust or intake system  "Different types of exhaust or intake system" means systems characterized by fundamental differences, such as the following:        1.3.1. systems bearing different trade marks or trade names;               1.3.2. systems in which the characteristics of the materials of a component differ, or in which the components are of different shape or size ; a change in the plating procedure (galvanization, aluminium coating, etc.) is not deemed to produce a difference of type;               1.3.3. systems in which the operating principles of at least one component differ;               1.3.4. systems in which the components are combined differently.                          1.4. Component of an exhaust or intake system  "Component of an exhaust or intake system" means one of the separate components which together form the exhaust system (e.g. exhaust pipes, the silencer proper) or the intake system (e.g. air filter).                   2. APPLICATION FOR EEC TYPE-APPROVAL      2.1. The application for EEC type-approval in respect of the sound level of a type of motor vehicle must be submitted by the manufacturer of the vehicle or his authorized representative.           2.2. It must be accompanied by the undermentioned documents in triplicate and the following information:        2.2.1. a description of the type of vehicle with reference to the points mentioned in item 1.1 above. The numbers and/or symbols identifying the engine type and vehicle type must be indicated;               2.2.2. a list, with appropriate identification, of the component parts of the exhaust and intake systems;               2.2.3. a drawing of the entire exhaust system with an indication of its position on the vehicle;               2.2.4. a detailed drawing of each component so that it can be easily located and identified, and an indication of the materials used.                          2.3. A vehicle representative of the type in respect of which type-approval is sought must be submitted to the technical service responsible for the tests by the vehicle manufacturer or his authorized representative.           2.4. At the request of the technical service, a specimen of the exhaust system and an engine of at least the same cylinder capacity and rated maximum power as that fitted to the vehicle in respect of which type-approval is sought must also be submitted.                  3. MARKINGS      3.1. The exhaust and intake system components, excluding fixing hardware and pipes, must bear:        3.1.1. the trade mark or name of the manufacturer of the systems and their components;               3.1.2. the manufacturer's trade description.                          3.2. These markings must be clearly legible and indelible.                  4. EEC TYPE-APPROVAL      4.1. If an application within the meaning of item 2.1 is approved, the competent authority will draw up a certificate, corresponding to the type which appears in Annex III, to be attached to the EEC vehicle type-approval certificate.                  5. SPECIFICATIONS      5.1. General specifications        5.1.1. The vehicle, its engine and exhaust and intake systems must be designed, constructed and mounted such that, under normal conditions of use and notwithstanding the vibrations to which they may be subject, the vehicle satisfies the requirements of this Directive.               5.1.2. The systems must be designed, constructed and mounted so that reasonable resistance to the corrosion phenomena to which they are exposed is obtained having regard to the conditions of use of the vehicle.                           5.2. Specifications relating to sound levels        5.2.1. Method of measurement          5.2.1.1. The sound emitted by the type of vehicle submitted for EEC type-approval must be measured in accordance with each of the two methods described in item 5.2.2.4 in the case of moving vehicles and item 5.2.3.4 in the case of stationary vehicles, respectively (1).                   5.2.1.2. The two values measured as specified in item 5.2.1.1, above, must be recorded in the test report and in a certificate corresponding to the model shown in Annex III.                                  5.2.2. Sound level of moving vehicles          5.2.2.1. Limiting values  The sound level measured in accordance with items 5.2.2.2 to 5.2.2.5, inclusive, of this Annex shall not exceed the following limits: >PIC FILE= "T0029276">                    5.2.2.2. Measuring instruments            5.2.2.2.1. Acoustic measurements  The apparatus used for measuring the noise level must be a precision sound-level meter of the type described in Publication 179 "Precision sound level meters", second edition, of the International Electrotechnical Commission (IEC). Measurements must be carried out using the "fast" response of the sound-level meter and the "A" weighting curve which are also described in that publication.  At the beginning and end of each set of measurements, the sound-level meter must be calibrated according to the manufacturer's instructions by means of an appropriate sound source (e.g. a pistonphone). The test must be considered invalid if the sound-level meter errors registered during this calibration exceed 1 dB.  (1) A stationary vehicle test is conducted in order to establish a reference value for the authorities which employ this method for the inspection of vehicles in service.                        5.2.2.2.2. Speed measurements  The engine speed and vehicle speed on the test section shall be determined with an accuracy of 3 % or better.                                          5.2.2.3. Conditions of measurement            5.2.2.3.1. Test site  The test site must consist of a central acceleration section surrounded by a substantially flat test area. The acceleration section must be level ; the track surface must be dry and such that rolling noise remains low.  The test track must be such that the conditions of a free sound field between the sound source and the microphone are attained to within 1 dB. This condition shall be deemed to be met if there are no large sound-reflecting objects such as fences, rocks, bridges or buildings within 50 m of the centre of the acceleration section. The surface of the site must be made of hard materials such as concrete, asphalt or any other acoustically equivalent material within a minimum radius of 10 m around the centre of the acceleration section and be free of powdery snow, tall grass, loose soil or cinders.  There must be no obstacle which could affect the sound field within the vicinity of the microphone and no persons shall stand between the microphone and the sound source. The observer carrying out the measurements must so position himself as not to affect the readings of the measuring instrument.                       5.2.2.3.2. Meteorological conditions  Measurements must not be made in poor atmospheric conditions. It must be ensured that the results are not affected by gusts of wind.                       5.2.2.3.3. Ambient noise  For measurements, the A-weighted sound level of sound sources other than those of the vehicle to be tested and of wind effects must be at least 10 dB(A) below the sound level produced by the vehicle. A suitable windscreen may be fitted to the microphone provided that account is taken of its effect on the sensitivity and directional characteristics of the microphone.                       5.2.2.3.4. Condition of the vehicle  For these measurements, the vehicle must be in running order as defined in item 2.6 of Annex I to Directive 70/156/EEC and, except in the case of vehicles which cannot be uncoupled, without trailer or semi-trailer.  The vehicle's tyres must be of the type normally fitted to such vehicles by the manufacturer and must be inflated to the appropriate pressure(s) for the unladen vehicle.  Before the measurements are made, the engine must be brought to its normal operating condition as regards temperatures, settings, fuel, spark plugs, carburettor(s), etc. (as appropriate). If the vehicle is fitted with fan(s) having an automatic actuating mechanism, this system must not be interfered with during the measurements.  Only the normal highway drive must be engaged in vehicles with more than two drive wheels.                                          5.2.2.4. Method of measurement            5.2.2.4.1. Nature and number of measurements  The maximum sound level expressed in A-weighted decibels (dB(A)) shall be measured as the vehicle is driven between lines AA' and BB' (Figure 1). The measurement shall be invalid if an abnormal discrepancy between the peak value and the general sound level is recorded.  At least two measurements must be taken on each side of the vehicle.                        5.2.2.4.2. Positioning of the microphone  The microphone must be located at a distance of 7 75 ± 0 72 m from the reference line CC' (Figure 1) of the track and 1 72 ± 0 71 m above the ground. Its axis of maximum sensitivity must be horizontal and perpendicular to the path of the vehicle (line CC').                       5.2.2.4.3. Conditions of operation              5.2.2.4.3.1. General conditions  For all measurements, the vehicle must be driven in a straight line over the acceleration section in such a way that the longitudinal median plane of the vehicle is as close as possible to the line CC'.  The vehicle must approach the line AA' at a steady initial road speed as specified in items 5.2.2.4.3.2 and 5.2.2.4.3.3. When the front end of the vehicle has reached the line AA', the throttle must be fully opened as quickly as practically possible. This throttle position must be maintained until the rear end of the vehicle reaches the line BB'; the throttle must then be returned to the idling position as quickly as possible.  The trailers of articulated vehicles which cannot be uncoupled must not be taken into account as regards the crossing of line BB'.                           5.2.2.4.3.2. Approach speed  The vehicle must approach the line AA' at a steady speed corresponding to the lower of the two following speeds:                - the speed corresponding to an engine speed equal to three-quarters of the speed (S) at which the engine develops rated maximum power;                               - 50 km/h.                                 If the vehicle is fitted with an automatic gearbox which has no manual selector, it must be tested at different approach speeds : 30, 40 and 50 km/h or at three-quarters of maximum road speed if this value is lower. The test result will be that obtained from the speed producing the maximum sound level.                           5.2.2.4.3.3. Choice of gear ratios (in vehicles fitted with gearboxes).                5.2.2.4.3.3.1. Manually-operated, non-automatic gearbox.  >PIC FILE= "T0029277">  >PIC FILE= "T0029279"> 5.2.2.4.3.3.2.  Automatic gearbox fitted with manual selector.  If the vehicle is fitted with a manual selector with X forward positions, the test must be conducted with the selector in position X ; the forced change-down facility (e.g. "kick-down") must be put out of action. If automatic change-down occurs after the line AA', has been crossed, the test must be restarted using, as necessary, the higher of the two selector positions X-1 and X-2, which enables the test to take place without automatic change-down (the forced change-down facility continuing to be out of action).  If the vehicle is fitted with a manually-operated auxiliary gearbox or a multiple ratio drive axle, the position corresponding to normal town driving must be used. The special selector positions for slow manoeuvres, or braking, must not be used.                   5.2.2.5. Interpretation of results            5.2.2.5.1. To take account of inaccuracies in the measuring instruments, the result obtained from each measurement shall be determined by deducting 1 dB(A) from the meter reading.                       5.2.2.5.2. The measurements shall be considered valid if the difference between two consecutive measurements on the same side of the vehicle does not exceed 2 dB(A).                       5.2.2.5.3. The highest sound level measured shall constitute the test result. Should the result exceed the maximum permissible sound level for the category of vehicle tested by 1 dB(A), two further measurements shall be made. Three of the four measurements thus obtained must fall within the prescribed limits.                                                         5.2.3. Sound level of the stationary vehicle          5.2.3.1. Sound level in the vicinity of vehicles  In order to facilitate subsequent checks on vehicles in use, the sound level must be measured close to the exhaust system outlet in accordance with the following requirements and the measurement results entered in the test report drawn up for the purpose of issuing the certificate referred to in Annex III.                   5.2.3.2. Measuring instruments            5.2.3.2.1. Acoustic measurements  A precision sound-level meter as defined in item 5.2.2.2.1 must be used for the measurements.                       5.2.3.2.2. Measurements of engine speed  The engine speed shall be determined by means of a tachometer having an accuracy of 3 % or better. The tachometer must be a separate one from the one of the vehicle.                                          5.2.3.3. Conditions of measurement            5.2.3.3.1. Test site (Figure 2)  Any area not subject to significant acoustic disturbance may be used as a test site. Flat surfaces which are covered in concrete, asphalt or any other hard surfacing and possess a high degree of reflectivity are particularly suitable ; surfaces consisting of earth which has been tamped down must not be used.   The test site must be in the form of a rectangle, the sides of which are at least 3 m from the sides of the vehicle. This rectangle must not contain any significant obstacles, e.g. an individual other than the observer and the driver. The vehicle must be positioned within the abovementioned rectangle so that the microphone is at least 1 m from any kerbstone.                       5.2.3.3.2. Meterological conditions  Measurements must not be made in poor atmospheric conditions. It must be ensured that the results are not affected by gusts of wind.                       5.2.3.3.3. Ambient noise  Readings on the measuring instruments produced by ambient noise and wind must be at least 10 dB(A) below the sound level to be measured. A suitable windscreen may be fitted to the microphone provided that account is taken of its effect on the sensitivity of the microphone.                       5.2.3.3.4. Condition of the vehicle  The vehicle engine must be brought to normal running temperature before measurements commence. If the vehicle is fitted with fan(s) having an automatic actuating mechanism, this system shall not be interfered with during the sound-level measurements.  During measurements, the gear lever must be in the neutral position.                                          5.2.3.4. Method of measurement            5.2.3.4.1. Nature and number of measurements  The maximum sound level expressed in A-weighted decibels (dB(A)) must be measured during the operating period referred to in item 5.2.3.4.3.  At least three measurements must be taken at each measuring point.                       5.2.3.4.2. Position of the microphone (Figure 2)  The microphone must be located level with the exhaust outlet or 0 72 m above the test-track surface, whichever is the higher. The microphone diaphragm must face the exhaust outlet at a distance of 0 75 m from the latter. The axis of maximum sensitivity of the microphone must be parallel to the track surface at an angle of 45° ± 10° to the vertical plane defined by the direction in which the exhaust gases are emitted.  The microphone must be positioned to the side of this vertical plane which gives the greatest possible distance between the microphone and the vehicle contour.  If the exhaust system has several outlets, the centres of which are not more than 0 73 m apart, and which are connected to the same silencer, the microphone must face the outlet closest to the vehicle contour or the outlet which is the highest above the track surface. In all other cases separate measurements must be taken at each of them, the highest figure recorded being taken as the test value.  In the case of vehicles fitted with a vertical exhaust outlet (e.g. commercial vehicles), the microphone must be positioned at the level of the exhaust outlet, facing upwards with its axis vertical. It must be positioned at a distance of 0 75 m from the side of the vehicle closest to the exhaust outlet.  Where the design of the vehicle is such that the microphone cannot be located as shown in Figure 2 because of the presence of obstacles which form part of the vehicle (e.g. spare wheel, fuel tank, battery compartment), a drawing clearly indicating the position for the microphone must be made when the measurement is conducted. As far as possible, the microphone must be more than 0 75 m from the nearest obstacle, and its axis of maximum sensitivity must face the exhaust outlet from the position least concealed by the abovementioned obstacles.                       5.2.3.4.3. Conditions of engine operation  Engine speed must be stabilized at three-quarters of the speed (S) at which the engine develops rated maximum power.   When constant engine speed is reached, the throttle must be rapidly returned to the idling position. The sound level must be measured over an operating period comprising brief maintenance of constant engine speed and the entire deceleration period, the maximum sound-level meter reading being taken as the test result.                                          5.2.3.5. Results (test report)            5.2.3.5.1. The test report drawn up for the purpose of issuing the certificate referred to in Annex III shall indicate all relevant data, particularly those used in measuring the sound of the stationary vehicle.                       5.2.3.5.2. Readings, rounded off to the nearest decibel, shall be taken from the measuring instrument.  Only those values obtained from three consecutive measurements which do not differ by more than 2 dB(A) respectively will be taken into consideration.                       5.2.3.5.3. The highest of these three values shall constitute the test result.                                                                    5.3. Exhaust systems containing fibrous materials        5.3.1. Fibrous materials shall not be used in the construction of silencers unless suitable measures are undertaken at the design or production stages to ensure that the efficiency required to comply with the limits imposed in item 5.2.2.1 is achieved on the road. Such a silencer shall be considered to be efficient on the road if the exhaust gases are not in contact with the fibrous materials or if the silencer of the prototype vehicle tested in accordance with the requirements of items 5.2.2 and 5.2.3 has been put into a normal state for road use before the sound-level measurements are taken. This can be achieved by using one of the three tests described in items 5.3.1.1, 5.3.1.2 and 5.3.1.3, below, or by removing the fibrous materials from the silencer.          5.3.1.1. Continuous road operation for 10 000 km            5.3.1.1.1. About half this operation shall consist of town driving and the other half of long-distance runs at high speed ; continuous road operation can be replaced by a corresponding test-track programme.                       5.3.1.1.2. The two speed regimes must be alternated on several occasions.                       5.3.1.1.3. The complete test programme must include a minimum of 10 breaks of at least three-hours duration in order to reproduce the effects of cooling and any condensation which may occur.                                          5.3.1.2. Conditioning on a test bench            5.3.1.2.1. Using standard parts and observing the vehicle manufacturer's instructions, the silencer must be fitted to the engine, which is coupled to a dynamometer.                       5.3.1.2.2. The test must be conducted in six six-hour periods with a break of at least 12 hours between each period in order to reproduce the effects of cooling any condensation which may occur.                       5.3.1.2.3. During each six-hour period, the engine shall be run under the following conditions in turn:              1. Five minutes at idling speed;                           2. One-hour sequence under 1/4 load at 3/4 of rated maximum speed (S);                           3. One-hour sequence under 1/2 load at 3/4 of rated maximum speed (S);                           4. 10-minute sequence under full load at 3/4 of rated maximum speed (S);                           5. 15-minute sequence under 1/2 load at rated maximum speed (S);               6. 30-minute sequence under 1/4 load at rated maximum speed (S).        Total duration of the six sequences : three hours.  Each period must comprise two sets of the six abovementioned sequences.  5.3.1.2.4.  During the test, the silencer must not be cooled by a forced draught simulating normal airflow around the vehicle. Nevertheless, at the request of the manufacturer, the silencer may be cooled in order not to exceed the temperature recorded at its inlet when the vehicle is running at maximum speed. 5.3.1.3. Conditioning by pulsation    5.3.1.3.1. The exhaust system or components thereof must be fitted to the vehicle referred to in item 2.3 or the engine referred to in item 2.4. In the former case the vehicle must be mounted on a roller dynamometer. In the second case, the engine must be mounted on a dynamometer.  The test apparatus, a detailed diagram of which is shown in Figure 3, must be fitted at the outlet of the exhaust system. Any other apparatus providing equivalent results is acceptable.       5.3.1.3.2. The test apparatus must be adjusted in such a way that the exhaust-gas flow is alternately interrupted and re-established by the quick-action valve for 2 500 cycles.       5.3.1.3.3. The valve must open when the exhaust-gas back pressure, measured at least 100 mm downstream of the intake flange, reaches a value of between 0 735 and 0 740 bar. It must close when this pressure does not differ by more than 10 % from its stabilized value with the valve open.       5.3.1.3.4. The time-delay switch shall be set for the duration of gas exhaust resulting from the provisions laid down in item 5.3.1.3.3 above.       5.3.1.3.5. Engine speed must be 75 % of the speed (S) at which the engine develops maximum power.       5.3.1.3.6. The power indicated by the dynamometer must be 50 % of the full-throttle power measured at 75 % of engine speed (S).       5.3.1.3.7. Any drainholes must be closed off during the test.       5.3.1.3.8. The entire test must be completed within 48 hours.  If necessary, one cooling period will be observed after each hour.        5.3.2.  If the provisions of Article 8 (3) of Directive 70/156/EEC concerning EEC type-approval are to be applied, the test method set out in item 5.3.1.2 above must be employed.   >PIC FILE= "T0029280">    >PIC FILE= "T0029281">    >PIC FILE= "T0029282">     ANNEX II  EEC TYPE-APPROVAL OF EXHAUST SYSTEMS AS SEPARATE TECHNICAL UNITS  (REPLACEMENT EXHAUST SYSTEMS)    0. SCOPE  This Annex applies to the type-approval, as separate technical units within the meaning of Article 9a of Directive 70/156/EEC, of exhaust systems or components thereof to be fitted to one or more given types of motor vehicle in categories M1 and N1 as replacement parts. 1. DEFINITIONS      1.1. "Replacement exhaust system or component thereof" means any part of the exhaust system defined in item 1.2.1 of Annex I intended to replace on a vehicle a part of the type granted EEC type-approval with the vehicle in accordance with Annex I.                  2. APPLICATION FOR EEC TYPE-APPROVAL      2.1. Application for EEC type-approval in respect of a replacement exhaust system or component thereof as a separate technical unit must be submitted by the vehicle manufacturer of the separate technical unit in question or by their authorized representatives.           2.2. Application for EEC type-approval in respect of each type of replacement exhaust system or component thereof must be accompanied by the undermentioned documents in triplicate and the following information: 2.2.1.  - a description of the type(s) of vehicle to which the system or components thereof are to be fitted with reference to the characteristics mentioned in item 1.1 of Annex I. The numbers and/or symbols designating the engine and vehicle type must be indicated;   2.2.2.  -  a description of the replacement exhaust system indicating the relative position of each system component, together with mounting instructions;  2.2.3.  -  detailed drawings of each component, so that they can be easily located and identified, and reference to the materials used.  These drawings must indicate the place provided for the compulsory affixing of the EEC type-approval.           2.3. At the request of the technical service concerned, the applicant must submit: 2.3.1.  -  two examples of the system in respect of which application for EEC type-approval has been made; 2.3.2.  -  an exhaust system of the type originally fitted to the vehicle when EEC type-approval was granted; 2.3.3.          - a vehicle representative of the type to which the system is to be fitted:               - which, as far as its noise level when moving is concerned, must be in such a condition that it respects the limits in item 5.2.2.1 of Annex I and does not exceed by more than 3 dB(A) the values obtained during the type-approval tests and               - which, as far as its noise level when stationary is concerned, respects the value obtained during the type-approval;  2.3.4.  -  a separate engine corresponding to the type of vehicle described above.                 3. MARKINGS      3.1. The replacement exhaust system or its components, excluding fixing hardware and pipes must bear : bear:  3.1.1.  -  the trade mark or trade name of the manufacturer of the replacement system and its components;  3.1.2.  -  the manufacturer's commercial description;  3.1.3.  -  the EEC type-approval number preceded by the distinctive letter(s) of the country granting EEC type-approval (1).           3.2. These marks must be clearly legible and indelible.                  4. EEC TYPE-APPROVAL      4.1. If an application within the meaning of item 2.1 is approved, the competent authority will draw up a certificate corresponding to the model shown in Annex IV. The type-approval number must be preceded by the distinctive letter(s) of the country granting EEC type-approval.                  5. SPECIFICATIONS      5.1. General specifications        5.1.1. The replacement exhaust system or component thereof must be designed, constructed and capable of being mounted so as to ensure that the vehicle complies with the provisions of this Directive under normal conditions of use, notwithstanding any vibrations to which it may be subject.               5.1.2. The exhaust system or components thereof must be designed, constructed and capable of being mounted so that reasonable resistance to the corrosion phenomena to which it/they is/are exposed is obtained having regard to the conditions of use of the vehicle.                          5.2. Specifications relating to sound levels        5.2.1. The acoustic efficiency of the replacement exhaust system or component thereof must be checked using the methods described in items 5.2.2.4 and 5.2.3.4 of Annex I.  When the replacement exhaust system or component thereof is mounted on the vehicle referred to in item 2.3.3 of this Annex, the sound levels obtained using the two methods (stationary and moving vehicle) must satisfy one of the following conditions:          5.2.1.1. they must not exceed the values obtained when this type of vehicle was granted EEC type-approval;                   5.2.1.2. they must not exceed the sound level values measured on the vehicle, referred to in item 2.3.3, when this is fitted with an exhaust system of the same type as that fitted to the vehicle when EEC type-approval was granted.                                             5.3. Measurement of vehicle performance        5.3.1. The replacement exhaust system or components thereof must be such as to ensure that vehicle performance is comparable with that achieved with the original equipment exhaust system or component thereof.               5.3.2. The replacement exhaust system or, depending on the manufacturer's choice, the components of this system must be compared with the original equipment exhaust system or components thereof, which are also in new condition, fitted in turn to the vehicle referred to in item 2.3.3.  (1) B = Belgium, D = Federal Republic of Germany, DK = Denmark, F = France, GR = Greece, I = Italy, IRL = Ireland, L = Luxembourg, NL = Netherlands, UK = United Kingdom.                5.3.3. The check must take the form of a measurement of pressure loss under the conditions specified in item 5.3.4.1 or 5.3.4.2. The value measured with the replacement exhaust system must not exceed the value measured with the original equipment system by more than 25 % under the conditions mentioned below.               5.3.4. Test Method          5.3.4.1. Engine test method  The measurement must be conducted on the engine referred to in item 2.3.4 coupled to a dynamometer.  With the throttle completely open, the bench shall be so adjusted as to obtain the engine speed (S) corresponding to the rated maximum power of the engine.  For the measurement of back pressure, the pressure tap must be placed at the distance from the exhaust manifold specified in Figures 1, 2 and 3.                   5.3.4.2. Vehicle test method  The measurements must be carried out on the vehicle referred to in item 2.3.3.  The test must be conducted:            - either on a road, or                       - on a roller dynamometer.                         With the throttle completely open, the engine must be loaded so as to obtain the engine speed (S) corresponding to the rated maximum power.  For the measurement of back pressure, the pressure tap must be placed at the distance from the exhaust manifold specified in Figures 1, 2 and 3.                                             5.4. Additional provisions in respect of exhaust systems or components thereof filled with fibrous materials  Fibrous materials must not be used in the manufacture of replacement exhaust systems or components thereof unless appropriate measures are taken during the design and production stages to ensure that a level of efficiency is attained corresponding to the limits set out in item 5.2.2.1 of Annex I.  Such a silencing system is deemed to be effective in traffic if the exhaust gases are not in contact with the fibrous materials or if, after the removal of the fibrous materials, the sound levels comply with the requirements set out in item 5.2.1 above, when the exhaust system is tested on a vehicle in accordance with the methods described in items 5.2.2 and 5.2.3 of Annex I.  If this condition is not observed, the entire exhaust system must be subjected to conditioning. This must be done using one of the three methods described in items 5.3.1.1, 5.3.1.2 and 5.3.1.3 of Annex I.  After conditioning, the sound level must be checked as specified in item 5.2.1 above.  When the procedure described in item 5.2.1.2 is employed, the applicant for EEC type-approval may ask for the conditioning of the original equipment exhaust system or submit one which has been emptied.                  6. CONFORMITY OF PRODUCTION      6.1. Any replacement exhaust system or component thereof bearing an EEC type-approval number pursuant to this Directive must conform to the approved type of exhaust system and comply with the requirements of item 5 above.           6.2. In order to check conformity as required by item 6.1 above, an exhaust system or component thereof bearing the EEC type-approval number must be taken from the series. Production is deemed to conform with the requirements of this Directive if the sound levels measured in accordance with item 5.2 do not exceed the level measured during the EEC type-approval tests of this type of exhaust system or component thereof by more than 1 dB(A).                    Back pressure - measuring points  >PIC FILE= "T0029283">     ANNEX III >PIC FILE= "T0029284">    >PIC FILE= "T0029285">     ANNEX IV >PIC FILE= "T0029286">    >PIC FILE= "T0029287">


Avis juridique important

|

31979L0109

Council Directive 79/109/EEC of 24 January 1979 amending Directive 64/432/EEC as regards brucellosis

Official Journal L 029 , 03/02/1979 P. 0020 - 0023 Greek special edition: Chapter 03 Volume 24 P. 0014  Spanish special edition: Chapter 03 Volume 15 P. 0118  Portuguese special edition Chapter 03 Volume 15 P. 0118

****( 1 ) OJ NO C 266 , 7 . 11 . 1977 , P . 45 .  ( 2 ) OJ NO C 18 , 23 . 1 . 1978 , P . 35 .  ( 3 ) OJ NO 121 , 29 . 7 . 1964 , P . 1977/64 .  ( 4 ) OJ NO L 26 , 31 . 1 . 1977 , P . 81 .        COUNCIL DIRECTIVE   OF 24 JANUARY 1979   AMENDING DIRECTIVE 64/432/EEC AS REGARDS BRUCELLOSIS  ( 79/109/EEC )   THE COUNCIL OF THE EUROPEAN   COMMUNITIES ,   HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY AND IN PARTICULAR ARTICLES 43 AND 100 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 COUNCIL DIRECTIVE 64/432/EEC OF 26 JUNE 1964 ON ANIMAL HEALTH PROBLEMS AFFECTING INTRA-COMMUNITY TRADE IN BOVINE ANIMALS AND SWINE ( 3 ), AS LAST AMENDED BY DIRECTIVE 77/98/EEC ( 4 ), LAYS DOWN COMMON STANDARDS ON ANTI-BRUCELLOSIS MEASURES APPLICABLE TO ANIMALS INTENDED FOR INTRA-COMMUNITY TRADE ;   WHEREAS EQUIVALENT MEASURES FOR THE DIAGNOSIS AND CONTROL OF BOVINE BRUCELLOSIS ARE , BY WAY OF DEROGATION , STILL APPLICABLE IN THE NEW MEMBER STATES ; WHEREAS IN ORDER TO ENSURE THE CONTINUATION OF FREE TRADE IN BOVINE ANIMALS AND SWINE WITHIN THE COMMUNITY , IT IS NECESSARY TO ADAPT THE TECHNICAL PROVISIONS OF DIRECTIVE 64/432/EEC WHICH RELATE TO BRUCELLOSIS IN ORDER TO TAKE ACCOUNT OF THIS SITUATION ;   WHEREAS , IN VIEW OF NEW SCIENTIFIC KNOWLEDGE AND TECHNICAL DEVELOPMENTS IN THE DIAGNOSIS AND CONTROL OF BOVINE BRUCELLOSIS , AN ADJUSTMENT OF EXISTING COMMUNITY MEASURES IN THIS FIELD IS NECESSARY ,   HAS ADOPTED THIS DIRECTIVE :   ARTICLE 1   IN ARTICLE 2 OF DIRECTIVE 64/432/EEC , THE FOLLOWING POINT SHALL BE ADDED :   ' ( O )  " REGION "  MEANS THAT PART OF A MEMBER STATE ' S TERRITORY WHICH IS AT LEAST 2 000 KM2 IN AREA AND WHICH IS SUBJECT TO INSPECTION BY THE COMPETENT AUTHORITIES AND INCLUDES AT LEAST ONE OF THE FOLLOWING ADMINISTRATIVE AREAS :   -  BELGIUM : PROVINCE/PROVINCIE ,   -  GERMANY : REGIERUNGSBEZIRK ,   -  DENMARK : AMT OR ISLAND ,   -  FRANCE : DEPARTEMENT ,   -  ITALY : PROVINCIA ,   -  LUXEMBOURG :  - ,   -  NETHERLANDS : PROVINCIE ,   -  UNITED KINGDOM :   -  ENGLAND , WALES AND NORTHERN IRELAND : COUNTY ,   -  SCOTLAND : DISTRICT OR ISLAND AREA ,   -  IRELAND : COUNTY . '   ARTICLE 2   IN ARTICLE 3 OF DIRECTIVE 64/432/EEC , THE FOLLOWING PARAGRAPHS SHALL BE ADDED :   ' 13 .  BY WAY OF DEROGATION FROM ANNEX A ( II ) ( A ) ( 1 ) ( C )  ( II ) IT MAY BE DECIDED , UNDER THE PROCEDURE LAID DOWN IN ARTICLE 12 , THAT IN A MEMBER STATE , OR PART OF A MEMBER STATE COMPOSED OF SEVERAL ADJACENT REGIONS , WHERE AT LEAST 99.8 % OF THE BOVINE HERDS HAVE BEEN DECLARED OFFICIALLY BRUCELLOSIS-FREE WITHIN THE MEANING OF ARTICLE 2 ( E ) FOR AT LEAST 10 YEARS , AND WHERE NO CASE OF ABORTION DUE TO A BRUCELLA INFECTION HAS BEEN RECORDED FOR AT LEAST THREE YEARS , THE INSPECTIONS FOR DETERMINING WHETHER THIS STATUS IS TO BE PRESERVED MAY BE CARRIED OUT IN A MANNER AND IN REGIONS TO BE DECIDED UNDER THE SAME PROCEDURE .   IF ONE OF THE CONDITIONS PROVIDED FOR IN THE FIRST SUBPARAGRAPH CEASES TO BE FULFILLED , THE COMMISSION  -  AFTER ASSESSING THE CIRCUMSTANCES IN WHICH THE BRUCELLOSIS HAS REAPPEARED  -  SHALL SUBMIT TO THE STANDING VETERINARY COMMITTEE A PROPOSAL FOR A DECISION TO RESCIND THE DEROGATION DECISION TAKEN IN RESPECT OF THAT MEMBER STATE OR OF THAT PART THEREOF COMPOSED OF SEVERAL ADJACENT REGIONS .   IT MAY ALSO BE DECIDED , UNDER THE PROCEDURE LAID DOWN IN ARTICLE 12 , THAT THE PROVISIONS OF ANNEX A ( II ) ( A ) ( 1 ) ( C )  ( III ) MAY BE APPLIED TO A PART OF A MEMBER STATE COMPRISING SEVERAL ADJACENT REGIONS . '   ARTICLE 3   ANNEX A ( II ) ( A ) ( 1 ) ( C ) ( I ) OF DIRECTIVE 64/432/EEC SHALL BE REPLACED BY THE FOLLOWING :   ' ( I ) HAVE SHOWN A BRUCELLA COUNT LOWER THAN 30 INTERNATIONAL UNITS OF AGGLUTINATION PER MILLILITRE WHEN GIVEN TWO OFFICIAL SERO-AGGLUTINATION TESTS AT INTERVALS OF AT LEAST THREE MONTHS AND AT MOST 12 MONTHS , CARRIED OUT IN ACCORDANCE WITH ANNEX C ; HOWEVER :   -  THE FIRST SERO-AGGLUTINATION TEST MAY BE REPLACED BY THREE RING-TESTS CARRIED OUT AT THREE-MONTHLY INTERVALS PROVIDED THAT THE SECOND SERO-AGGLUTINATION TEST IS CARRIED OUT AT LEAST SIX WEEKS AFTER THE THIRD RING-TEST ;   -  THE FIRST SERO-AGGLUTINATION TEST REFERRED TO IN THE FIRST INDENT MAY BE REPLACED BY A BUFFERED BRUCELLA ANTIGEN TEST CARRIED OUT IN ACCORDANCE WITH ANNEX C ( D ); ' .   ARTICLE 4   IN ANNEX A ( II ) ( A ) ( 1 ) ( D ) ( I ) OF DIRECTIVE 64/432/EEC , IN THE INTRODUCTORY SENTENCE , THE WORDS ' OR A PART OF A MEMBER STATE COMPRISING SEVERAL ADJACENT REGIONS '  SHALL BE INSERTED AFTER THE WORDS ' IN MEMBER STATES ' .   ARTICLE 5   IN ANNEX A ( II ) ( A ) ( 1 ) ( C ) OF DIRECTIVE 64/432/EEC , THE FOLLOWING SUBPARAGRAPHS SHALL REPLACE THE EXISTING SUBPARAGRAPH ( II ):   ' ( II ) ARE CHECKED ANNUALLY TO ESTABLISH THAT BRUCELLOSIS IS NOT PRESENT BY THREE RING-TESTS CARRIED OUT AT INTERVALS OF AT LEAST THREE MONTHS OR TWO RING-TESTS AT AN INTERVAL OF AT LEAST THREE MONTHS AND ONE SEROLOGICAL TEST  ( SERO-AGGLUTINATION TEST OR BUFFERED BRUCELLA ANTIGEN TEST OR PLASMA-AGGLUTINATION TEST OR PLASMA RING-TEST ) CARRIED OUT NOT LESS THAN SIX WEEKS AFTER THE SECOND RING-TEST . IF RING-TESTS ARE NOT CARRIED OUT , TWO SEROLOGICAL TESTS  ( SERO-AGGLUTINATION TEST OR BUFFERED BRUCELLA ANTIGEN TEST OR PLASMA-AGGLUTINATION TEST OR PLASMA RING-TEST ) SHALL BE CARRIED OUT EACH YEAR AT INTERVALS OF AT LEAST THREE MONTHS AND NOT MORE THAN SIX MONTHS ;   WHERE , IN A MEMBER STATE OR REGION THEREOF IN WHICH ALL BOVINE HERDS ARE SUBJECT TO OFFICIAL OPERATIONS TO COMBAT BRUCELLOSIS , NOT MORE THAN 1 % OF BOVINE HERDS IS INFECTED , IT SHALL BE SUFFICIENT TO CARRY OUT EACH YEAR TWO RING-TESTS AT AN INTERVAL OF AT LEAST THREE MONTHS , OR ONE SEROLOGICAL TEST ( SERO-AGGLUTINATION TEST OR BUFFERED BRUCELLA ANTIGEN TEST OR PLASMA-AGGLUTINATION TEST OR PLASMA RING-TEST );  ( III ) DEROGATIONS MAY BE PERMITTED FROM THE REQUIREMENTS LAID DOWN IN ( II ) REGARDING ANNUAL CHECKS THAT BRUCELLOSIS IS NOT PRESENT IN ANY MEMBER STATE WHERE AT LEAST 99.8 % OF BOVINE HERDS HAVE BEEN RECOGNIZED AS OFFICIALLY BRUCELLOSIS-FREE FOR AT LEAST FOUR YEARS ; IN THIS CASE , THE INTERVAL BETWEEN CHECKS MAY BE EXTENDED TO TWO YEARS AND THE CHECKS MUST BE CARRIED OUT USING ONE OF THE SEROLOGICAL TESTS REFERRED TO IN ( II ); ' .   ARTICLE 6   ANNEX A ( II ) ( A ) ( 2 ) ( B ) OF DIRECTIVE 64/432/EEC SHALL BE REPLACED BY THE FOLLOWING :   ' ( B ) ALL OR SOME OF THE FEMALE BOVINE ANIMALS HAVE BEEN VACCINATED :   -  WHEN SIX MONTHS OLD AT MOST , WITH LIVE BUCK 19 VACCINE OR OTHER VACCINES APPROVED UNDER THE PROCEDURE LAID DOWN IN ARTICLE 12 ,   -  WHEN 15 MONTHS OLD AT MOST , WITH KILLED 45/20 ADJUVANT VACCINE OFFICIALLY INSPECTED AND RECOGNIZED ; ' .   ARTICLE 7   ANNEX A ( II ) ( A ) ( 2 ) ( C ) OF DIRECTIVE 64/432/EEC SHALL BE REPLACED BY THE FOLLOWING :   ' ( C ) ALL THE BOVINE ANIMALS SATISFY THE CONDITIONS LAID DOWN IN 1 ( B ) AND ( C ); HOWEVER , THE BOVINE ANIMALS UNDER 30 MONTHS OLD WHICH HAVE BEEN VACCINATED WITH LIVE BUCK 19 VACCINE MAY SHOW A BRUCELLA COUNT EQUAL TO OR HIGHER THAN 30 I.U . OF AGGLUTINATION PER MILLILITRE BUT LOWER THAN 80 I.U . OF AGGLUTINATION PER MILLILITRE PROVIDED THAT , WHEN THE COMPLEMENT FIXATION REACTION IS TESTED , THEY SHOW :   -  A COUNT LOWER THAN 30 EEC UNITS IN THE CASE OF FEMALES VACCINATED LESS THAN 12 MONTHS PREVIOUSLY ,   -  A COUNT LOWER THAN 20 EEC UNITS IN ALL OTHER CASES .   THE SERO-AGGLUTINATION TESTS REFERRED TO IN 1 ( C ) ( I ), FIRST INDENT , MAY BE REPLACED BY BUFFERED BRUCELLA ANTIGEN TESTS CARRIED OUT IN ACCORDANCE WITH ANNEX C ( D ); ' .   ARTICLE 8   IN ANNEX A ( II ) ( A ) ( 2 ) ( D ), SECOND PARAGRAPH , FIRST LINE OF DIRECTIVE 64/432/EEC , THE WORDS ' WITH LIVE BUCK 19 VACCINE '  SHALL BE INSERTED BETWEEN THE WORDS ' VACCINATED ' AND ' AND ' .   ARTICLE 9   IN ANNEX C OF DIRECTIVE 64/432/EEC THE FOLLOWING SECTIONS SHALL BE ADDED :   ' D . THE BUFFERED BRUCELLA ANTIGEN TEST   THE BUFFERED BRUCELLA ANTIGEN TEST MAY BE CARRIED OUT USING ONE OF THE FOLLOWING METHODS :   A . MANUAL TEST   1 . THE STANDARD SERUM SHALL BE THE SECOND INTERNATIONAL STANDARD ANTI-BRUCELLA ABORTUS SERUM WHICH IS SUPPLIED BY THE CENTRAL VETERINARY LABORATORY , WEYBRIDGE , SURREY , ENGLAND .   2 . THE ANTIGEN SHALL BE PREPARED WITHOUT REFERENCE TO THE CELL CONCENTRATION , BUT ITS SENSITIVITY MUST BE STANDARDIZED IN RELATION TO THE SECOND INTERNATIONAL STANDARD ANTI-BRUCELLA ABORTUS SERUM IN SUCH A WAY THAT THE ANTIGEN PRODUCES A POSITIVE REACTION WITH SERUM DILUTION OF 1 : 47.5 AND A NEGATIVE REACTION WITH A DILUTION OF 1 : 55 .   3 . THE ANTIGEN SHALL BE SUSPENDED IN BUFFERED BRUCELLA ANTIGEN DILUENT AT A PH OF 3.65  MORE OR LESS  0.5 AND MAY HAVE BEEN STAINED BY THE USE OF ROSE BENGAL DYE .   4 . WEYBRIDGE STRAIN NO 99 OR USDA 1119 OR ANY OTHER STRAIN OF EQUIVALENT SENSITIVITY MUST BE USED FOR PREPARING THE ANTIGEN .   5 . THE CULTURE MEDIA USED FOR KEEPING THE STRAIN IN THE LABORATORY AND FOR PRODUCING THE ANTIGEN MUST BE SUCH THAT THEY DO NOT ENCOURAGE BACTERIAL DISSOCIATION ( S  -  R ); POTATO AGAR MEDIUM OR CONTINUOUS CULTURE METHODS SHOULD BE USED .   6 . THE ANTIGEN SHALL BE TESTED AGAINST EIGHT FREEZE-DRIED KNOWN POSITIVE AND NEGATIVE SERA .   7 . THE OFFICIAL SUPERVISION AND CONTROL OF STANDARD SERUM AND ANTIGEN SHALL BE CARRIED OUT BY THE OFFICIAL BODIES LISTED IN ANNEX C ( A ) ( 9 ).   8 . THE ANTIGEN SHALL BE DELIVERED READY FOR USE .   9 . THE BUFFERED BRUCELLA ANTIGEN TEST SHALL BE CARRIED OUT IN THE FOLLOWING MANNER :  ( A ) ONE DROP ( 0.03 ML ) OF ANTIGEN SHOULD BE PLACED ALONGSIDE ONE DROP ( 0.03 ML ) OF THE SERUM ON A WHITE PLATE ;  ( B ) THEY SHOULD BE MIXED WITH AN APPLICATOR STICK , FIRST IN A STRAIGHT LINE AND THEN IN A CIRCLE OF ABOUT 10 TO 12 MM DIAMETER ;  ( C ) THE PLATE SHOULD THEN BE ROCKED BACK AND FORTH FOR FOUR MINUTES ( ABOUT 30 TIMES PER MINUTE );  ( D ) READINGS SHOULD BE TAKEN IN A GOOD LIGHT ; IF THERE IS NO EVIDENCE OF AGGLUTINATION , THE TEST SHALL BE REGARDED AS NEGATIVE ; ANY DEGREE OF AGGLUTINATION SHALL BE REGARDED AS POSITIVE , UNLESS THERE HAS BEEN EXCESSIVE DRYING ROUND THE EDGES .   B . AUTOMATED METHOD   THE AUTOMATED METHOD MUST BE AT LEAST AS SENSITIVE AND ACCURATE AS THE MANUAL METHOD .   E . PLASMA RING-TEST   A . EXTRACTION OF THE PLASMA   THE TUBE CONTAINING BLOOD , COAGULATION OF WHICH HAVING BEEN INHIBITED BY THE ADDITION OF EDTA , SHOULD BE CENTRIFUGED FOR THREE AT 3 000 R/MIN AND SUBSEQUENTLY KEPT AT 37  * C FOR 12 TO 24 HOURS .   B . EVALUATION   0.2 ML OF STABILIZED PLASMA SHOULD BE PLACED IN A TUBE WITH 1 ML OF UNTREATED MILK . AFTER MIXING , ONE DROP ( 0.05 ML ) OF ABR-ANTIGEN SHOULD BE ADDED AND THE WHOLE AGAIN MIXED . THE ANTIGEN SHOULD BE STANDARDIZED IN RELATION TO A STANDARD ANTIGEN SUPPLIED BY THE BODY REFERRED TO IN ( A ) ( 9 ) ( A ).   FOLLOWING AN INCUBATION PERIOD OF 45 MINUTES AT 37  * C , A READING SHOULD BE TAKEN WITHIN 15 MINUTES . THE RESULT SHALL BE REGARDED AS POSITIVE IF THE COLOUR OF THE RING HAS BECOME THE SAME AS , OR DARKER THAN , THAT OF THE MILK COLUMN .   F . PLASMA AGGLUTINATION   THE PLASMA EXTRACTED IN ACCORDANCE WITH E ( A ) MAY BE USED IMMEDIATELY AFTER CENTRIFUGING , NO THERMAL STABILIZATION BEING NECESSARY .   0.05 ML OF PLASMA SHOULD BE MIXED WITH 1 ML OF ANTIGEN FOR 50 % SERO-AGGLUTINATION , WHICH CORRESPONDS TO A DILUTION OF 1 : 20 FOR SERO-AGGLUTINATION . A READING SHOULD BE TAKEN AFTER 18 TO 24 HOURS INCUBATION AT 37  * C . % OR MORE AGGLUTINATION SHALL BE REGARDED AS POSITIVE . '   ARTICLE 10   THE MEMBER STATES SHALL BRING INTO FORCE THE LAWS , REGULATIONS AND ADMINISTRATIVE PROVISIONS NECESSARY TO COMPLY WITH THIS DIRECTIVE BY 1 APRIL 1979 AND SHALL FORTHWITH INFORM THE COMMISSION THEREOF .   ARTICLE 11   THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .   DONE AT BRUSSELS , 24 JANUARY 1979 .   FOR THE COUNCIL   THE PRESIDENT   J . FRANCOIS-PONCET