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31977L0391

Council Directive 77/391/EEC of 17 May 1977 introducing Community measures for the eradication of brucellosis, tuberculosis and leucosis in cattle

Official Journal L 145 , 13/06/1977 P. 0044 - 0047 Finnish special edition: Chapter 3 Volume 8 P. 0244  Greek special edition: Chapter 03 Volume 18 P. 0144  Swedish special edition: Chapter 3 Volume 8 P. 0244  Spanish special edition: Chapter 03 Volume 12 P. 0195  Portuguese special edition Chapter 03 Volume 12 P. 0195

COUNCIL DIRECTIVE  of 17 May 1977  introducing Community measures for the eradication of brucellosis, tuberculosis and leucosis in cattle  (77/391/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 one of the tasks of the Community in the veterinary field is to improve the state of health of livestock, and thus to make stock-breeding more profitable, while also protecting man against certain diseases which are communicable to him;  Whereas such measures must contribute to the abolition of barriers to trade in fresh meat or live animals between Member States, which are due to differences in health situations;  Whereas Community initiatives to this effect must initially concentrate on certain diseases against which immediate action is possible ; whereas this is true of brucellosis, tuberculosis and leucosis;  Whereas in so far as the proposed measures are intended to achieve the objectives set out in Article 39 (1) (a) of the Treaty they shall constitute common measures within the meaning of Article 6 (1) of Council Regulation (EEC) No 729/70 of 21 April 1970 on the financing of the common agricultural policy (3);  Whereas, in as much as the Community contributes to the financing of the common measures, it must be in a position to ascertain that the provisions adopted by Member States for the implementation of those measures will contribute towards achievement of the objectives thereof ; whereas, to this end, provision should be made for a procedure establishing close cooperation between Member States and the Commission within the Standing Veterinary Committee, set up by Decision 68/361/EEC (4),  HAS ADOPTED THIS DIRECTIVE:    Article 1 The purpose of this Directive is to improve the state of health of cattle in the Community by means of Community action to accelerate or intensify the eradication of brucellosis and tuberculosis and to eradicate leucosis.   CHAPTER 1 Technical provisions relating to brucellosis, tuberculosis and leucosis  Article 2 1. For the purpose of this Directive, Member States in which the cattle population is infected by bovine brucellosis shall draw up plans for accelerating the eradication of this disease in their national territories, under the conditions laid down in paragraphs 2 and 3.  2.    (a) The plans for accelerating the eradication of bovine brucellosis shall be so devised that on their completion herds are classed as "officially brucellosis-free", in accordance with Community provisions in this field, and in particular Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (5), as last amended by Directive 75/379/EEC (6).  (1)OJ No C 6, 10.1.1977, p. 13. (2)OJ No C 56, 7.3.1977, p. 28. (3)OJ No L 94, 28.4.1970, p. 13. (4)OJ No L 255, 28.10.1968, p. 23. (5)OJ No 121, 29.7.1964, p. 1977/64. (6)OJ No L 172, 3.7.1975, p. 17.        (b) The plan must list the measures to be taken to accelerate and intensify the eradication of bovine brucellosis and must specify the measures to combat and prevent this disease.        3. The Member States shall report to the Commission:    (a) the percentage and total number of herds subject to control measures, and of herds with confirmed bovine brucellosis;       (b) the total numbers:      - of animals subject to control measures,           - of animals with suspected brucellosis or considered to be infected,           - of infected animals,           - of animals slaughtered;                  (c) the scheduled duration of the initial eradication programmes and of the accelerated plans;       (d) the method applied for checking on the effective application of the accelerated plans;       (e) the national budgetary allocation for the eradication of bovine brucellosis and the breakdown by items of these allocations.         The information referred to under (a), (b) and (e) shall be provided for the three years preceding the application of the acceleration measures, and annually thereafter.  4. Member States with bovine brucellosis-free cattle populations shall inform the Commission of all the measures taken to prevent the resurgence of this disease.   Article 3 1. For the purposes of this Directive, Member States in which the cattle populations are infected with bovine tuberculosis shall draw up plans for accelerating the eradication of this disease in their national territories, under the conditions laid down in paragraphs 2 and 3.  2.    (a) The plans for accelerating the eradication of bovine tuberculosis shall be so devised that on their completion herds are classed as "officially tuberculosis-free", in accordance with Community provisions in this field and Directive 64/432/EEC in particular.       (b) The plans must list the measures to be taken to accelerate, intensify or carry through the eradication of bovine tuberculosis and must specify the measures to combat and prevent this disease.        3. The Member States shall report to the Commission:    (a) the percentages and total numbers of herds subject to control measures, and of herds with confirmed bovine tuberculosis;       (b) the total numbers:      - of animals subject to control measures,           - of animals with suspected tuberculosis or considered to be infected,           - of infected animals,           - of animals slaughtered;                  (c) the scheduled duration of the initial eradication programmes and of the accelerated plans;       (d) the methods applied for checking on the effective application of the accelerated plans;       (e) the national budgetary allocations for the eradication of bovine tuberculosis and the breakdown by items of these allocations.         The information referred to under (a), (b) and (e), shall be provided for the three years preceding the application of the acceleration measures, and annually thereafter.  4. Member States with bovine tuberculosis-free cattle populations shall inform the Commission of all the measures taken to prevent the resurgence of this disease.   Article 4 For the purposes of this Directive, the Member States which have established the presence of enzootic leucosis among cattle in their territories shall draw up plans for the eradication of this disease.  The plans must specify the measures for combating this disease.  The tests or methods used to declare a herd free of leucosis shall be those laid down in Commission Decision 73/30/EEC of 23 January 1973 authorizing the Federal Republic of Germany to apply special health guarantees for the prevention of leucosis in the case of bovine animals imported for breeding or production (1), as last amended by Decision 75/64/EEC (2), or any other tests or methods recognized by the procedure laid down in Article 11.  Member States shall furnish the Commission, at the latter's request, with all information regarding the execution of the plans.  CHAPTER 2 Common and financial provisions  Article 5 In so far as they are intended to achieve the objectives defined in Article 39 (1) (a) of the Treaty, the measures  (1)OJ No L 77, 26.3.1973, p. 40. (2)OJ No L 21, 28.1.1975, p. 20.   provided for in Chapter 1 shall constitute common measures within the meaning of Article 6 (1) of Regulation (EEC) No 729/70.   Article 6 1. The time for carrying out the common measures is three years.  2. The total contribution by the European Agricultural Guidance and Guarantee Fund, hereinafter called "the Fund" to the cost of the common measures is estimated at 130 million units of account, for the three years.   Article 7 1. Expenditure by Member States in respect of measures taken under Articles 2, 3 and 4 shall be eligible for assistance from the Guidance Section of the Fund within the limits indicated in Article 6.  2. The Guidance Section of the Fund shall pay to Member States 60 units of account per cow and 30 units of account per bovine animal other than cows slaughtered under the measures mentioned in Chapter 1.  3. Detailed rules for applying this Article shall be adopted according to the procedure laid down in Article 13 of Regulation (EEC) No 729/70.  4. Measures taken by Member States shall not be eligible to benefit from financial contributions by the Community unless a favourable decision according to Article 9 has been given in respect of the provisions relating thereto.   Article 8 1. Applications for payment shall relate to slaughterings carried out by Member States in the course of a calendar year and shall be submitted to the Commission before 1 July of the following year.  2. The granting of aid from the Fund shall be decided according to Article 7 (1) of Regulation (EEC) No 729/70.  3. Detailed rules for applying this Article shall be adopted according to the procedure laid down in Article 13 of Regulation (EEC) No 729/70.   Article 9 1. Member States shall forward to the Commission the plans provided for in Articles 2 and 3 and the information required under Articles 2 (3) (c) and (d), and 3 (3) (c) and (d) prior to their implementation, not later than three months after the entry into effect of this Directive, and annually thereafter. The plans provided for in Article 4 shall be forwarded annually to the Commission by Member States, and prior to their implementation in the case of Member States which have not yet drawn up plans.  2. The Commission shall examine the plans forwarded in accordance with paragraph 1 for the purpose of determining whether, in terms of conformity with this Directive and having regard to the objectives thereof, the conditions for financial contribution by the Community are met. Within two months following the receipt of any plan, the Commission shall submit a draft Decision to the Standing Veterinary Committee. The Committee shall issue its opinion in accordance with the procedure laid down in Article 11, within a time limit set by the chairman. The Fund Committee shall be consulted on the financial aspects.   Article 10 The Commission shall make regular on-the-spot checks to verify from a veterinary viewpoint whether the plans are being applied.  Member States shall take the necessary steps to facilitate these checks and shall in particular ensure that the experts are supplied at their request with all information and documentation needed for assessing the execution of the plans.  The provisions for implementing this Article, especially as regards the frequency and method of carrying out the checks referred to in the first subparagraph, the rules governing the appointment of official veterinarians and the procedure which they must follow when drawing up their report, shall be laid down according to the procedure set out in Article 11.   Article 11 1. Where the procedure laid down in this Article is to be followed, the matter shall be referred by the chairman, either on his own initiative or at the request of a Member State, to the Standing Veterinary Committee, hereinafter called "the Committee".  2. Within the Committee the votes of the Member States shall be weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote.  3. The Commission representative shall submit a draft of the measures to be adopted. The Committee shall deliver its opinion on such measures within a time limit set by the chairman, having regard to the urgency of the questions under examination. An opinion shall not be delivered unless it receives a minimum of 41 votes in its favour.   4. The Commission shall adopt the measures and shall apply them immediately, where they are in accordance with the opinion of the Committee. Where they are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay submit a proposal to the Council on the measures to be adopted. The Council shall adopt the measures by a qualified majority.  If the Council has not adopted any measures within three months of the date on which the proposal was referred to it, the Commission shall adopt the proposed measures and apply them immediately, save where the Council has decided against these measures by a simple majority.   Article 12 Article 11 shall apply until 21 June 1981.   Article 13 The Council, acting on a proposal from the Commission and before 1 August 1977, shall adopt the provisions concerning the criteria which the national eradication plans, referred to in Articles 2, 3 and 4, must satisfy in order to qualify for a financial contribution by the Community.   Article 14 The Member States shall put into effect the laws, regulations and administrative provisions necessary for compliance with this Directive, on the date laid down for the entry into force of the provisions referred to in Article 13.   Article 15 This Directive is addressed to the Member States.     Done at Brussels, 17 May 1977.  For the Council  The President  J. SILKIN


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31996L0096

Council Directive 96/96/EC of 20 December 1996 on the approximation of the laws of the Member States relating to roadworthiness tests for motor vehicles and their trailers

Official Journal L 046 , 17/02/1997 P. 0001 - 0019

COUNCIL DIRECTIVE 96/96/EC of 20 December 1996 on the approximation of the laws of the Member States relating to roadworthiness tests for motor vehicles and their trailers THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 75 thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the Economic and Social Committee (2),Acting in accordance with the procedure laid down in Article 189c of the Treaty (3),(1) Whereas Council Directive 77/143/EEC of 29 December 1976 on the approximation of the laws of the Member States relating to roadworthiness tests for motor vehicles and their trailers (4) has been substantially amended on a number of occasions; whereas, now that it is to be further amended, the Directive should, for reasons of clarity, be consolidated into a single text;(2) Whereas, within the framework of the common transport policy, certain road traffic within the Community should operate under the most favourable circumstances as regards both safety and competitive conditions applying to carriers in the Member States;(3) Whereas the growth of road traffic and the resultant increase in danger and nuisances present all Member States with safety problems of a similar nature and seriousness;(4) Whereas the present standards and methods of testing vary from one Member State to another and this situation affects the equivalence of safety and environmental performance levels of tested vehicles operating in the Member States; whereas, moreover, this state of affairs is likely to disturb the conditions governing competition between transport undertakings of the various Member States;(5) Whereas it is therefore necessary to harmonize as far as is practicable the frequency of tests and the compulsory items to be tested;(6) Whereas testing during the life cycle of a vehicle should be relatively simple, quick and inexpensive;(7) Whereas the minimum Community standards and methods to be used for testing the items listed in Annex II should therefore be defined in separate Directives;(8) Whereas, as a transitional measure, national standards remain applicable in respect of items not covered by separate Directives;(9) Whereas it is necessary to adapt rapidly to technical progress the standards and methods laid down in the separate Directives and, in order to facilitate implementation of the measures required for this purpose, to establish a procedure for close cooperation between the Member States and the Commission within a committee on the adaptation to technical progress of roadworthiness tests;(10) Whereas with regard to braking systems it would be premature to set values for air pressure settings and build-up times, etc., given the variance in the equipment and methods within the Community;(11) Whereas it is the intention to amend this Directive further so as to include a harmonious and improved test methodology;(12) Whereas, until such time as there are harmonized test procedures and practices, Member States may use their judgment as to the test procedure they use to establish whether the vehicles in question meet the braking requirements;(13) Whereas each Member State must ensure, within its own area of jurisdiction, that roadworthiness tests are conducted methodically and to a high standard;(14) Whereas the Commission should verify the practical application of this Directive and report to the European Parliament and the Council at regular intervals on its findings;(15) Whereas it is recognized by all concerned with vehicle testing that the method of testing and, in particular, whether the vehicle is tested in a laden, part-laden or unladen condition, can influence the degree of confidence testers have as to the roadworthiness of the braking system;(16) Whereas the prescription of brake force reference values for various laden conditions for each vehicle model would help restore that confidence; whereas this Directive enables testing under this regime as an alternative to testing against minimum performance values for each vehicle category;(17) Whereas with regard to braking systems the scope of this Directive relates in the main to vehicles which have been granted component type-approval in accordance with Directive 71/320/EEC (5) although it is recognized that certain types of vehicle have been granted such approval in accordance with national standards which may differ from the requirements of this Directive;(18) Whereas Member States may extend the scope of the braking test to include vehicles or test items outside the scope of this Directive;(19) Whereas Member States may make the braking test more stringent or increase the frequency of testing;(20) Whereas this Directive is intended to maintain emissions at a low level throughout the useful life of a vehicle by means of regular exhaust emission tests and to ensure that vehicles which are major polluters are withdrawn from service until they are brought to a proper state of maintenance;(21) Whereas bad tuning and inadequate maintenance are detrimental not only to the engine but also to the environment since they cause increased pollution and fuel consumption; whereas it is important that environment-friendly transport be developed;(22) Whereas in the case of compression-ignition (diesel) engines measurement of the opacity of the exhaust fumes is deemed to be an adequate indicator of the condition of the vehicle's state of maintenance, with regard to emissions;(23) Whereas for positive-ignition (petrol) engines measurement of carbon monoxide emissions from the exhaust pipe when the engine is idling is deemed to be an adequate indicator of the vehicle's state of maintenance, with regard to emissions;(24) Whereas the failure rate in exhaust-emission tests for vehicles which have not been regularly maintained may well be high;(25) Whereas in the case of petrol-engined vehicles for which the type-approval standards specify that they must be equipped with advanced emission control systems such as three-way catalytic converters which are lambda-probe controlled, the regular emission test standards must be more stringent than for conventional vehicles;(26) Whereas Member States may, if appropriate, exclude from the scope of this Directive certain vehicles that are considered to be of historic interest; whereas they may also establish their own testing standards for such vehicles; whereas, however, such a right must not lead to the application of stricter standards than those which the vehicles concerned were originally designed to meet;(27) Whereas it must be possible to adapt this Directive from time to time to take account of developments in vehicle construction which facilitate in-service testing and in test methods which reflect more closely the actual conditions in which a vehicle is used;(28) Whereas Council Directive 92/6/EEC (6) requires the installation and use of speed limitation devices in certain categories of road vehicles;(29) Whereas pending developments in the technology of speed-limitation devices which would make it easier to monitor them, certain parts of such devices may nevertheless already undergo a series of checks at the roadworthiness test where this is possible;(30) Whereas the correct functioning of speed limitation devices is currently left to Member States to determine using whatever means they consider to be appropriate; whereas it is the intention to harmonize the test methods and standards in due course;(31) Whereas the Commission should assess in-service checks on the correct functioning of speed-limitation devices and submit a report to the Council; whereas the conclusions of that report will form the basis of any further proposals for changes in the rules applicable to speed-limitation devices;(32) Whereas technical requirements relating to taxis and ambulances are similar to those for private cars; whereas the items to be checked may therefore be similar, although the frequency of tests is different;(33) Whereas in view of the expected impact of this Directive on the sector in question and in the light of the principle of subsidiarity, the Community measures provided for in this Directive are necessary to achieve harmonization of the rules on roadworthiness tests, to prevent distortion of competition between road hauliers and to guarantee that vehicles are properly checked and maintained; whereas these aims could not be achieved in full by the Member States acting individually;(34) Whereas this Directive makes no difference to the obligations of the Member States concerning the deadlines for transposition into national law and for implementation of the Directives which have been repealed,HAS ADOPTED THIS DIRECTIVE:CHAPTER I General provisions Article 1 1. In each Member State, motor vehicles registered in that State and their trailers and semi-trailers shall undergo periodic roadworthiness tests in accordance with this Directive and in particular its Annexes I and II.2. The categories of vehicles to be tested, the frequency of the roadworthiness tests and the items which must be tested are listed in Annexes I and II.Article 2 The roadworthiness tests provided for in this Directive shall be carried out by the State, or by a public body entrusted with the task by the State or by bodies or establishments designated and directly supervised by the State, including duly authorized private bodies. In particular, when establishments designated as vehicle testing centres also perform motor vehicle repairs, Member States shall make every effort to ensure the objectivity and high quality of the vehicle testing.Article 3 1. Member States shall take such measures as they deem necessary to make it possible to prove that a vehicle has passed a roadworthiness test complying with at least the provisions of this Directive.These measures shall be notified to the other Member States and to the Commission.2. Each Member State shall, on the same basis as if it had itself issued the proof, recognize the proof issued in another Member State showing that a motor vehicle registered on the territory of that other State, together with its trailer or semi-trailer, have passed a roadworthiness test complying with at least the provisions of this Directive.3. Member States shall apply suitable procedures to establish, as far as practicable, that the brake performance of the vehicles registered in their territory meets the requirements specified in this Directive.CHAPTER II Exceptions and derogations Article 4 1. Member States shall have the right to exclude from the scope of this Directive vehicles belonging to the armed forces, the forces of law and order and the fire service.2. Member States may, after consulting the Commission, exclude from the scope of this Directive or subject to special provisions, certain vehicles operated or used in exceptional conditions and vehicles which are never, or hardly ever, used on public highways, including vehicles of historic interest manufactured before 1 January 1960 or which are temporarily withdrawn from circulation.3. Member States may, after consulting the Commission, set their own testing standards for vehicles considered to be of historic interest.Article 5 Notwithstanding the provisions of Annexes I and II, Member States may:- bring forward the date for the first compulsory roadworthiness test and, where appropriate, submit the vehicle for testing prior to registration,- shorten the interval between two successive compulsory tests,- make the testing of optional equipment compulsory,- increase the number of items to be tested,- extend the periodic test requirement to other categories of vehicles,- prescribe special additional tests,- require for vehicles registered on their territory higher minimum standards for braking efficiency than those specified in Annex II and may include a test on vehicles with heavier loads provided such requirements do not exceed those of the vehicle's original type-approval.Article 6 1. By way of derogation from the provisions of Annexes I and II, and until 1 January 1993, Member States may:- postpone the date of the first compulsory roadworthiness test,- extend the interval between two successive compulsory roadworthiness tests,- reduce the number of items to be tested,- amend the categories of vehicles subject to compulsory roadworthiness tests,provided that all the light commercial vehicles referred to in section 5 of Annex I are required to undergo roadworthiness tests in accordance with this Directive before that date.However, in Member States where there was no system of regular roadworthiness testing comparable to that intended by this Directive for this category of vehicles as at 28 July 1988, paragraph 1 shall apply until 1 January 1995.2. With regard to the private cars referred to in section 6 of Annex I, paragraph 1 shall apply until 1 January 1994.However, in Member States where there was no system of regular roadworthiness testing comparable to that intended by this Directive for this category of vehicles as at 31 December 1991, paragraph 1 shall apply until 1 January 1998.CHAPTER III Final provisions Article 7 1. The Council, acting by a qualified majority on a proposal from the Commission, shall adopt the separate Directives necessary to define the minimum standards and methods for testing the items listed in Annex II.2. Any amendments which are necessary to adapt the standards and methods defined in the separate Directives to technical progress shall be adopted in accordance with the procedure laid down in Article 8.Article 8 1. The Commission shall be assisted by a committee on the adaptation to technical progress of the Directive on roadworthiness tests for motor vehicles and their trailers, hereinafter referred to as the 'Committee`, which shall consist of representatives of the Member States with a representative of the Commission in the chair.2. The Committee shall adopt its own rules of procedure.3. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in the abovementioned Article. The chairman shall not vote.4. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.(b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.If, within three months of the submission of the proposal to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.Article 9 1. The Commission shall, no later than 31 December 1998, submit a report to the Council on the implementation of roadworthiness testing of private cars, accompanied by any proposal deemed necessary, with particular reference to the frequency and content of tests.2. No later than three years after the introduction of regular testing of speed limitation devices, the Commission shall examine whether, on the basis of the experience gained, the tests laid down are sufficient to detect defective or manipulated speed limitation devices or whether the rules need to be amended.Article 10 The Directives listed in Annex III, Part A are hereby repealed as from the date indicated in Article 11, without prejudice to the obligations of the Member States concerning the deadlines for transposition and implementation set out in Annex III, Part B.References to the repealed Directives shall be construed as reference to this Directive and should be read in accordance with the correlation tables set out in Annex IV.Article 11 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 9 March 1998. They shall forthwith inform the Commission thereof.When Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such reference at the time 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 texts of the provisions of national law which they adopt in the field governed by this Directive.3. Member States shall adopt the measures necessary to implement the system of tests laid down in this Directive. The measures adopted must be effective, proportionate and dissuasive.Article 12 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.Article 13 This Directive is addressed to the Member States.Done at Brussels, 20 December 1996.For the CouncilThe PresidentS. BARRETT(1) OJ No C 193, 4. 7. 1996, p. 5 and 31.(2) OJ No C 39, 12. 2. 1996, p. 24.(3) European Parliament opinion of 29 February 1996 (OJ No C 78, 18. 3. 1996, p. 27), Council common position of 18 June 1996 (OJ No C 248, 26. 8. 1996, p. 49) and European Parliament Decision of 24 October 1996 (OJ No C 347, 18. 11. 1996).(4) OJ No L 47, 18. 2. 1977, p. 47. Directive as last amended by Commission Directive 94/23/EC (OJ No L 147, 14. 6. 1994, p. 6).(5) Council Directive 71/320/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to the braking devices of certain categories of motor vehicles and their trailers (OJ No L 202, 6. 9. 1971, p. 37). Directive as last amended by Directive 91/422/EEC (OJ No L 233, 22. 8. 1991, p. 21).(6) Council Directive 92/6/EEC of 10 February 1992 on the installation and use of speed limitation devices for certain categories of motor vehicles in the Community (OJ No L 57, 2. 3. 1992, p. 27).ANNEX I CATEGORIES OF VEHICLES SUBJECT TO ROADWORTHINESS TESTS AND FREQUENCY OF THE TESTS >TABLE>ANNEX II ITEMS TO BE COMPULSORILY TESTED The test must cover at least the items listed below, provided that these are related to the obligatory equipment of the vehicle being tested in the Member State concerned.The tests covered by this Annex may be carried out visually without disassembly of vehicle parts.Where the vehicle is found to be defective with regard to the test items below, the competent authorities in the Member States must adopt a procedure for setting the conditions under which the vehicle may be used before passing another roadworthiness test.>TABLE>>TABLE>VEHICLES IN CATEGORIES 1, 2, 3, 4, 5 AND 68.2. Exhaust emissions8.2.1. Motor vehicles equipped with positive-ignition (petrol) engines(a) Where the exhaust emissions are not controlled by an advanced emission control system such as a three-way catalytic converter which is lambda-probe controlled:1. Visual inspection of the exhaust system in order to check that there are no leakages.2. If appropriate, visual inspection of the emission control system in order to check that the required equipment has been fitted.After a reasonable period of engine conditioning (taking account of the vehicle manufacturer's recommendations) the carbon monoxide (CO) content of the exhaust gases is measured when the engine is idling (no load).The maximum permissible CO content in the exhaust gases is that stated by the vehicle manufacturer. Where this information is not available or where Member States' competent authorities decide not to use it as a reference value, the CO content must not exceed the following:- for vehicles registered or put into service for the first time between the date from which Member States required the vehicles to comply with Directive 70/220/EEC (1) and 1 October 1986: CO - 4,5 % vol,- for vehicles registered or put into service for the first time after 1 October 1986: CO - 3,5 % vol.(b) Where the exhaust emissions are controlled by an advanced emission control system such as a three-way catalytic converter which is lambda-probe controlled:1. Visual inspection of the exhaust system in order to check that there are no leakages and that all parts are complete.2. Visual inspection of the emission control system in order to check that the required equipment has been fitted.3. Determination of the efficiency of the vehicle's emission control system by measuring the lambda value and the CO content of the exhaust gases in accordance with section 4 or with the procedures proposed by the manufacturers and approved at the time of type-approval. For each of the tests the engine is conditioned in accordance with the vehicle manufacturer's recommendations.4. Exhaust pipe emissions - limit values- Measurement at engine idling speed:The maximum permissible CO content in the exhaust gases is that stated by the vehicle manufacturer. Where this information is not available, the maximum CO content must not exceed 0,5 % vol.- Measurement at high idle speed, engine speed to be at least 2 000 min-1:CO content: maximum 0,3 % volLambda: 1 ± 0,03 in accordance with the manufacturer's specifications.8.2.2. Motor vehicles equipped with compression ignition (diesel) enginesMeasurement of exhaust gas opacity with free acceleration (no load from idling up to cut-off speed). The level of concentration must not exceed the level recorded on the plate pursuant to Directive 72/306/EEC (2). Where this information is not available or where Member States' competent authorities decide not to use it as a reference, the limit values of the coefficient of absorption are as follows:Maximum coefficient of absorption for:- naturally aspirated diesel engines = 2,5 m-1,- turbo-charged diesel engines = 3,0 m-1or equivalent values where use is made of equipment of a type different from that used for EC type-approval.Vehicles registered or put into service for the first time before 1 January 1980 are exempted from these requirements.8.2.3. Test equipmentVehicle emissions are tested using equipment designed to establish accurately whether the limit values prescribed or indicated by the manufacturer have been complied with.8.2.4. Where, during EC type-approval, a type of vehicle is found not to have satisfied the limit values laid down by this Directive, the Member States may lay down higher limit values for that type of vehicle on the basis of proof supplied by the manufacturer. They must forthwith inform the Commission thereof and it in turn must inform the other Member States.>TABLE>(1) Council Directive 70/220/EEC of 20 March 1970 on the approximation of the laws of the Member States relating to measures to be taken against air pollution by emissions from motor vehicles (OJ No L 76, 9. 3. 1970, p. 1) and corrigendum (OJ No L 81, 11. 4. 1970, p. 15), as last amended by European Parliament and Council Directive 94/12/EC (OJ No L 100, 19. 4. 1994, p. 42).(2) Council Directive 72/306/EEC of 2 August 1972 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of pollutants from diesel engines for use in vehicles (OJ No L 190, 20. 8. 1972, p. 1), Directive as last amended by Commission Directive 89/491/EEC (OJ No L 238, 15. 8. 1989, p. 43).ANNEX III PART A Repealed Directives (referred to in Article 10) Council Directive 77/143/EEC of 29 December 1976 on the approximation of the laws of the Member states relating to roadworthiness tests for motor vehicles and their trailers and the Directives amending that Directive:- Council Directive 88/449/EEC,- Council Directive 91/225/EEC,- Council Directive 91/328/EEC,- Council Directive 92/54/EEC,- Council Directive 92/55/EEC,- Commission Directive 94/23/EC.PART B >TABLE>ANNEX IV >TABLE>>TABLE>>TABLE>


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31986L0560

Thirteenth Council Directive 86/560/EEC of 17 November 1986 on the harmonization of the laws of the Member States relating to turnover taxes - Arrangements for the refund of value added tax to taxable persons not established in Community territory

Official Journal L 326 , 21/11/1986 P. 0040 - 0041 Finnish special edition: Chapter 9 Volume 1 P. 0130  Swedish special edition: Chapter 9 Volume 1 P. 0130

*****THIRTEENTH  COUNCIL DIRECTIVE  of 17 November 1986  on the harmonization of the laws of the Member States relating to turnover taxes - Arrangements for the refund of value added tax to taxable persons not established in Community territory  (86/560/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 Sixth Council Directive 77/388/EEC of 17 May 1977 on the harmonization of the laws of the Member States relating to turnover taxes - Common system of value added tax: uniform basis of assessment (1), and in particular Article 17 (4) thereof,  Having regard to the proposal from the Commission (2),  Having regard to the opinion of the European Parliament (3),  Having regard to the opinion of the Economic and Social Committee (4),  Whereas Article 8 of Directive 79/1072/EEC (5) on the arrangements for the refund of value added tax to taxable persons not established in the territory of the country provides that in the case of taxable persons not established in the territory of the Community, Member States may refuse refunds or impose special conditions;  Whereas there is a need to ensure the harmonious development of trade relations between the Community and third countries based on the provisions of Directive 79/1072/EEC, while taking account of the varying situations encountered in third countries;  Whereas certain forms of tax evasion or avoidance should be prevented,  HAS ADOPTED THIS DIRECTIVE:  Article 1  For the purposes of this Directive:  1. 'A taxable person not established in the territory of the Community' shall mean a taxable person as referred to in Article 4 (1) of Directive 77/388/EEC who, during the period referred to in Article 3 (1) of this Directive, has had in that territory neither his business nor a fixed establishment from which business transactions are effected, nor, if no such business or fixed establishment exists, his permanent address or usual place of residence, and who, during the same period, has supplied no goods or services deemed to have been supplied in the Member State referred to in Article 2, with the exception of:  (a) transport services and services ancillary thereto, exempted pursuant to Article 14 (1) (i), Article 15 or Article 16 (1), B, C and D of Directive 77/388/EEC;  (b) services provided in cases where tax is payable solely by the person to whom they are supplied, pursuant to Article 21 (1) (b) of Directive 77/388/EEC;  2. 'Territory of the Community' shall mean the territories of the Member States in which Directive 77/388/EEC is applicable.  Article 2  1. Without prejudice to Articles 3 and 4, each Member State shall refund to any taxable person not established in the territory of the Community, subject to the conditions set out below, any value added tax charged in respect of services rendered or moveable property supplied to him in the territory or the country by other taxable persons or charged in respect of the importation of goods into the country, in so far as such goods and services are used for the purposes of the transactions referred to in Article 17 (3) (a) and (b) of Directive 77/388/EEC or of the provision of services referred to in point 1 (b) of Article 1 of this Directive.  2. Member States may make the refunds referred to in paragraph 1 conditional upon the granting by third States of comparable advantages regarding turnover taxes.  3. Member States may require the appointment of a tax representative.  Article 3  1. The refunds referred to in Article 2 (1) shall be granted upon application by the taxable person. Member States shall determine the arrangements for submitting applications, including the time limits for doing so, the period which applications should cover, the authority competent to receive them and the minimum amounts in respect of which applications may be submitted. They shall also determine the arrangements for making refunds, including the time limits for doing so. They shall impose on the applicant such obligations as are necessary to determine whether the application is justified and to prevent fraud, in particular the obligation to provide proof that he is engaged in an economic activity in accordance with Article 4 (1) of Directive 77/388/EEC. The applicant must certify, in a written declaration, that, during the period prescribed, he has not carried out any transaction which does not fulfil the conditions laid down in point 1 of Article 1 of this Directive.  2. Refunds may not be granted under conditions more favourable than those applied to Community taxable persons.  Article 4  1. For the purposes of this Directive, eligibility for refunds shall be determined in accordance with Article 17 of Directive 77/388/EEC as applied in the Member State where the refund is paid.  2. Member States may, however, provide for the exclusion of certain expenditure or make refunds subject to additional conditions.  3. This Directive shall not apply to supplies of goods which are or or may be exempted under point 2 of Article 15 of Directive 77/388/EEC.  Article 5  1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1988 at the latest. This Directive shall apply only to applictions for refunds concerning value added tax charged on purchases of goods or services invoiced or on imports effected on or after that date.  2. Member States shall communicate to the Commission the main provisions of national law which they adopt in the field covered by this Directive and shall inform the Commission of the use they make of the option afforded by Article 2 (2). The Commission shall inform the other Member States thereof.  Article 6  Within three years of the date referred to in Article 5, the Commission shall, after consulting the Member States, submit a report to the Council and to the European Parliament on the application of this Directive, particularly as regards the application of Article 2 (2).  Article 7  As from the date on which this Directive is implemented, and at all events by the date mentioned in Article 5, the last sentence of Article 17 (4) of Directive 77/388/EEC and Article 8 of Directive 79/1072/EEC shall cease to have effect in each Member State.  Article 8  This Directive is addressed to the Member States.  Done at Brussels, 17 November 1986.  For the Council  The President  N. LAWSON  (1) OJ No L 145, 13. 6. 1977, p. 1.  (2) OJ No C 223, 27. 8. 1982, p. 5 and  OJ No C 196, 23. 7. 1983, p. 6.  (3) OJ No C 161, 20. 6. 1983, p. 111.  (4) OJ No C 176, 4. 7. 1983, p. 22.  (5) OJ No L 331, 27. 12. 1979, p. 11.


title: Directive 2009/24/EC of the European Parliament and of the Council of 23 April 2009 on the legal protection of computer programs (Codified version) (Text with EEA relevance)

text:
               5.5.2009

               EN

               Official Journal of the European Union

               L 111/16

      DIRECTIVE 2009/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 23 April 2009
   on the legal protection of computer programs
   (Codified version)
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community and in particular Article 95 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               The content of Council Directive 91/250/EEC of 14 May 1991 on the legal protection of computer programs (3) has been amended (4). In the interests of clarity and rationality the said Directive should be codified.

               (2)

               The development of computer programs requires the investment of considerable human, technical and financial resources while computer programs can be copied at a fraction of the cost needed to develop them independently.

               (3)

               Computer programs are playing an increasingly important role in a broad range of industries and computer program technology can accordingly be considered as being of fundamental importance for the Community's industrial development.

               (4)

               Certain differences in the legal protection of computer programs offered by the laws of the Member States have direct and negative effects on the functioning of the internal market as regards computer programs.

               (5)

               Existing differences having such effects need to be removed and new ones prevented from arising, while differences not adversely affecting the functioning of the internal market to a substantial degree need not be removed or prevented from arising.

               (6)

               The Community's legal framework on the protection of computer programs can accordingly in the first instance be limited to establishing that Member States should accord protection to computer programs under copyright law as literary works and, further, to establishing who and what should be protected, the exclusive rights on which protected persons should be able to rely in order to authorise or prohibit certain acts and for how long the protection should apply.

               (7)

               For the purpose of this Directive, the term ‘computer program’ shall include programs in any form, including those which are incorporated into hardware. This term also includes preparatory design work leading to the development of a computer program provided that the nature of the preparatory work is such that a computer program can result from it at a later stage.

               (8)

               In respect of the criteria to be applied in determining whether or not a computer program is an original work, no tests as to the qualitative or aesthetic merits of the program should be applied.

               (9)

               The Community is fully committed to the promotion of international standardisation.

               (10)

               The function of a computer program is to communicate and work together with other components of a computer system and with users and, for this purpose, a logical and, where appropriate, physical interconnection and interaction is required to permit all elements of software and hardware to work with other software and hardware and with users in all the ways in which they are intended to function. The parts of the program which provide for such interconnection and interaction between elements of software and hardware are generally known as ‘interfaces’. This functional interconnection and interaction is generally known as ‘interoperability’; such interoperability can be defined as the ability to exchange information and mutually to use the information which has been exchanged.

               (11)

               For the avoidance of doubt, it has to be made clear that only the expression of a computer program is protected and that ideas and principles which underlie any element of a program, including those which underlie its interfaces, are not protected by copyright under this Directive. In accordance with this principle of copyright, to the extent that logic, algorithms and programming languages comprise ideas and principles, those ideas and principles are not protected under this Directive. In accordance with the legislation and case-law of the Member States and the international copyright conventions, the expression of those ideas and principles is to be protected by copyright.

               (12)

               For the purposes of this Directive, the term ‘rental’ means the making available for use, for a limited period of time and for profit-making purposes, of a computer program or a copy thereof. This term does not include public lending, which, accordingly, remains outside the scope of this Directive.

               (13)

               The exclusive rights of the author to prevent the unauthorised reproduction of his work should be subject to a limited exception in the case of a computer program to allow the reproduction technically necessary for the use of that program by the lawful acquirer. This means that the acts of loading and running necessary for the use of a copy of a program which has been lawfully acquired, and the act of correction of its errors, may not be prohibited by contract. In the absence of specific contractual provisions, including when a copy of the program has been sold, any other act necessary for the use of the copy of a program may be performed in accordance with its intended purpose by a lawful acquirer of that copy.

               (14)

               A person having a right to use a computer program should not be prevented from performing acts necessary to observe, study or test the functioning of the program, provided that those acts do not infringe the copyright in the program.

               (15)

               The unauthorised reproduction, translation, adaptation or transformation of the form of the code in which a copy of a computer program has been made available constitutes an infringement of the exclusive rights of the author. Nevertheless, circumstances may exist when such a reproduction of the code and translation of its form are indispensable to obtain the necessary information to achieve the interoperability of an independently created program with other programs. It has therefore to be considered that, in these limited circumstances only, performance of the acts of reproduction and translation by or on behalf of a person having a right to use a copy of the program is legitimate and compatible with fair practice and must therefore be deemed not to require the authorisation of the rightholder. An objective of this exception is to make it possible to connect all components of a computer system, including those of different manufacturers, so that they can work together. Such an exception to the author's exclusive rights may not be used in a way which prejudices the legitimate interests of the rightholder or which conflicts with a normal exploitation of the program.

               (16)

               Protection of computer programs under copyright laws should be without prejudice to the application, in appropriate cases, of other forms of protection. However, any contractual provisions contrary to the provisions of this Directive laid down in respect of decompilation or to the exceptions provided for by this Directive with regard to the making of a back-up copy or to observation, study or testing of the functioning of a program should be null and void.

               (17)

               The provisions of this Directive are without prejudice to the application of the competition rules under Articles 81 and 82 of the Treaty if a dominant supplier refuses to make information available which is necessary for interoperability as defined in this Directive.

               (18)

               The provisions of this Directive should be without prejudice to specific requirements of Community law already enacted in respect of the publication of interfaces in the telecommunications sector or Council Decisions relating to standardisation in the field of information technology and telecommunication.

               (19)

               This Directive does not affect derogations provided for under national legislation in accordance with the Berne Convention on points not covered by this Directive.

               (20)

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

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Object of protection
   1.   In accordance with the provisions of this Directive, Member States shall protect computer programs, by copyright, as literary works within the meaning of the Berne Convention for the Protection of Literary and Artistic Works. For the purposes of this Directive, the term ‘computer programs’ shall include their preparatory design material.
   2.   Protection in accordance with this Directive shall apply to the expression in any form of a computer program. Ideas and principles which underlie any element of a computer program, including those which underlie its interfaces, are not protected by copyright under this Directive.
   3.   A computer program shall be protected if it is original in the sense that it is the author's own intellectual creation. No other criteria shall be applied to determine its eligibility for protection.
   4.   The provisions of this Directive shall apply also to programs created before 1 January 1993, without prejudice to any acts concluded and rights acquired before that date.
   Article 2
   Authorship of computer programs
   1.   The author of a computer program shall be the natural person or group of natural persons who has created the program or, where the legislation of the Member State permits, the legal person designated as the rightholder by that legislation.
   Where collective works are recognised by the legislation of a Member State, the person considered by the legislation of the Member State to have created the work shall be deemed to be its author.
   2.   In respect of a computer program created by a group of natural persons jointly, the exclusive rights shall be owned jointly.
   3.   Where a computer program is created by an employee in the execution of his duties or following the instructions given by his employer, the employer exclusively shall be entitled to exercise all economic rights in the program so created, unless otherwise provided by contract.
   Article 3
   Beneficiaries of protection
   Protection shall be granted to all natural or legal persons eligible under national copyright legislation as applied to literary works.
   Article 4
   Restricted acts
   1.   Subject to the provisions of Articles 5 and 6, the exclusive rights of the rightholder within the meaning of Article 2 shall include the right to do or to authorise:

               (a)

               the permanent or temporary reproduction of a computer program by any means and in any form, in part or in whole; in so far as loading, displaying, running, transmission or storage of the computer program necessitate such reproduction, such acts shall be subject to authorisation by the rightholder;

               (b)

               the translation, adaptation, arrangement and any other alteration of a computer program and the reproduction of the results thereof, without prejudice to the rights of the person who alters the program;

               (c)

               any form of distribution to the public, including the rental, of the original computer program or of copies thereof.

         2.   The first sale in the Community of a copy of a program by the rightholder or with his consent shall exhaust the distribution right within the Community of that copy, with the exception of the right to control further rental of the program or a copy thereof.
   Article 5
   Exceptions to the restricted acts
   1.   In the absence of specific contractual provisions, the acts referred to in points (a) and (b) of Article 4(1) shall not require authorisation by the rightholder where they are necessary for the use of the computer program by the lawful acquirer in accordance with its intended purpose, including for error correction.
   2.   The making of a back-up copy by a person having a right to use the computer program may not be prevented by contract in so far as it is necessary for that use.
   3.   The person having a right to use a copy of a computer program shall be entitled, without the authorisation of the rightholder, to observe, study or test the functioning of the program in order to determine the ideas and principles which underlie any element of the program if he does so while performing any of the acts of loading, displaying, running, transmitting or storing the program which he is entitled to do.
   Article 6
   Decompilation
   1.   The authorisation of the rightholder shall not be required where reproduction of the code and translation of its form within the meaning of points (a) and (b) of Article 4(1) are indispensable to obtain the information necessary to achieve the interoperability of an independently created computer program with other programs, provided that the following conditions are met:

               (a)

               those acts are performed by the licensee or by another person having a right to use a copy of a program, or on their behalf by a person authorised to do so;

               (b)

               the information necessary to achieve interoperability has not previously been readily available to the persons referred to in point (a); and

               (c)

               those acts are confined to the parts of the original program which are necessary in order to achieve interoperability.

         2.   The provisions of paragraph 1 shall not permit the information obtained through its application:

               (a)

               to be used for goals other than to achieve the interoperability of the independently created computer program;

               (b)

               to be given to others, except when necessary for the interoperability of the independently created computer program; or

               (c)

               to be used for the development, production or marketing of a computer program substantially similar in its expression, or for any other act which infringes copyright.

         3.   In accordance with the provisions of the Berne Convention for the protection of Literary and Artistic Works, the provisions of this Article may not be interpreted in such a way as to allow its application to be used in a manner which unreasonably prejudices the rightholder's legitimate interests or conflicts with a normal exploitation of the computer program.
   Article 7
   Special measures of protection
   1.   Without prejudice to the provisions of Articles 4, 5 and 6, Member States shall provide, in accordance with their national legislation, appropriate remedies against a person committing any of the following acts:

               (a)

               any act of putting into circulation a copy of a computer program knowing, or having reason to believe, that it is an infringing copy;

               (b)

               the possession, for commercial purposes, of a copy of a computer program knowing, or having reason to believe, that it is an infringing copy;

               (c)

               any act of putting into circulation, or the possession for commercial purposes of, any means the sole intended purpose of which is to facilitate the unauthorised removal or circumvention of any technical device which may have been applied to protect a computer program.

         2.   Any infringing copy of a computer program shall be liable to seizure in accordance with the legislation of the Member State concerned.
   3.   Member States may provide for the seizure of any means referred to in point (c) of paragraph 1.
   Article 8
   Continued application of other legal provisions
   The provisions of this Directive shall be without prejudice to any other legal provisions such as those concerning patent rights, trade-marks, unfair competition, trade secrets, protection of semi-conductor products or the law of contract.
   Any contractual provisions contrary to Article 6 or to the exceptions provided for in Article 5(2) and (3) shall be null and void.
   Article 9
   Communication
   Member States shall communicate to the Commission the provisions of national law adopted in the field governed by this Directive.
   Article 10
   Repeal
   Directive 91/250/EEC, as amended by the Directive indicated in Annex I, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex I, Part B.
   References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex II.
   Article 11
   Entry into force
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 12
   Addressees
   This Directive is addressed to the Member States.

      Done at Strasbourg, 23 April 2009.

            For the European Parliament

            The President

         H.-G. PÖTTERING

            For the Council

            The President

         P. NEČAS

      (1)  OJ C 204, 9.8.2008, p. 24.

      (2)  Opinion of the European Parliament of 17 June 2008 (not yet published in the Official Journal) and Council Decision of 23 March 2009.

      (3)  OJ L 122, 17.5.1991, p. 42.

      (4)  See Annex I, Part A.

      ANNEX I
      PART A

         Repealed Directive with its amendment

         (referred to in Article 10)

                  Council Directive 91/250/EEC
                  (OJ L 122, 17.5.1991, p. 42)

                  Council Directive 93/98/EEC
                  (OJ L 290, 24.11.1993, p. 9)

                  Article 11(1) only

            PART B

         List of time-limits for transposition into national law

         (referred to in Article 10)

                  Directive

                  Time-limit for transposition

                  91/250/EEC

                  31 December 1992

                  93/98/EEC

                  30 June 1995

      ANNEX II

         Correlation table

                  Directive 91/250/EEC

                  This Directive

                  Article 1(1), (2) and (3)

                  Article 1(1), (2) and (3)

                  Article 2(1), first sentence

                  Article 2(1), first subparagraph

                  Article 2(1), second sentence

                  Article 2(1), second subparagraph

                  Article 2(2) and (3)

                  Article 2(2) and (3)

                  Article 3

                  Article 3

                  Article 4, introductory words

                  Article 4(1), introductory words

                  Article 4(a)

                  Article 4(1), point (a)

                  Article 4(b)

                  Article 4(1), point (b)

                  Article 4(c), first sentence

                  Article 4(1), point (c)

                  Article 4(c), second sentence

                  Article 4(2)

                  Articles 5, 6 and 7

                  Articles 5, 6 and 7

                  Article 9(1), first sentence

                  Article 8, first paragraph

                  Article 9(1), second sentence

                  Article 8, second paragraph

                  Article 9(2)

                  Article 1(4)

                  Article 10(1)

                  —

                  Article 10(2)

                  Article 9

                  —

                  Article 10

                  —

                  Article 11

                  Article 11

                  Article 12

                  —

                  Annex I

                  —

                  Annex II


Avis juridique important

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31999L0076

Commission Directive 1999/76/EC of 23 July 1999 establishing a Community method of analysis for the determination of lasalocid sodium in feedingstuffs (Text with EEA relevance)

Official Journal L 207 , 06/08/1999 P. 0013 - 0017

COMMISSION DIRECTIVE 1999/76/ECof 23 July 1999establishing a Community method of analysis for the determination of lasalocid sodium in feedingstuffs(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs(1), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 2 thereof,(1) Whereas Directive 70/373/EEC stipulates that official controls of feedingstuffs for the purpose of checking compliance with the requirements arising under the laws, regulations and administrative provisions governing their quality and composition must be carried out using Community methods of sampling and analysis;(2) Whereas Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs(2), as last amended by Commission Regulation (EC) No 866/1999 of 26 April 1999(3) stipulates that the lasalocid sodium content must be indicated on the labelling where these substances are added to premixtures and feedingstuffs;(3) Whereas Community methods of analysis must be established for checking these substances;(4) Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs,HAS ADOPTED THIS DIRECTIVE:Article 1The Member States shall provide that analyses conducted with a view to official controls of the lasalocid content of feedingstuffs and premixtures are carried out using the method set out in Annex hereto.Article 2The Member States shall bring into force, not later than 31 January 2000, the laws, regulations or administrative provisions necessary to comply with the provisions of this Directive. They shall immediately inform the Commission thereof.They shall apply the measures from 1 February 2000.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.Article 3This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.Article 4This Directive is addressed to the Member States.Done at Brussels, 23 July 1999.For the CommissionFranz FISCHLERMember of the Commission(1) OJ L 170, 3.8.1970, p. 2.(2) OJ L 270, 14.12.1970, p. 1.(3) OJ L 108, 27.4.1999, p. 20.ANNEXDETERMINATION OF LASALOCID SODIUMSodium salt of a polyether monocarboxylic acid produced by Streptomyces lasaliensis1. Purpose and scopeThe method is for the determination of lasalocid sodium in feedingstuffs and premixtures. The limit of detection is 5 mg/kg, the limit of determination is 30 mg/kg.2. PrincipleLasalocid sodium is extracted from the sample into acidified methanol and determined by reversed-phase high performance liquid chromatography (HPLC) using a spectrofluorimetric detector.3. Reagents3.1. Potassium dihydrogen phosphate (KH2PO4)3.2. Orthophosphoric acid, w = 85 %3.3. Orthophosphoric acid solution, σ = 20 %Dilute 23,5 ml of orthophosphoric acid (3.2) to 100 ml with water.3.4. 6-Methyl-2-heptylamine (1,5-dimethylhexylamine), w = 99 %3.5. Methanol, HPLC grade3.6. Hydrochloric acid, ρ20 1,19 g/ml3.7. Phosphate buffer solution, c = 0,01 mol/lDissolve 1,36 g of KH2PO4 (3.1) in 500 ml of water (3.11 ), add 3,5 ml of orthophosphoric acid (3.2) and 10,0 ml of 6-methyl-2-heptylamine (3.4). Adjust the pH to 4,0 with orthophosphoric acid solution (3.3) and dilute to 1000 ml with water (3.11).3.8. Acidified methanolTransfer 5,0 ml of hydrochloric acid (3.6) into a 1000 ml graduated flask, make up to the mark with methanol (3.5) and mix. This solution must be prepared freshly before use.3.9. HPLC mobile phase, phosphate buffer-methanol solution 5 + 95 (V + V)Mix 5 ml of phosphate buffer solution (3.7) with 95 ml of methanol (3.5).3.10. Lasalocid sodium standard substance with guaranteed purity, C34H53O8Na (sodium salt of a polyether monocarboxylic acid produced by Streptomyces lasaliensis), E7633.10.1. Lasalocid sodium stock standard solution, 500 μg/mlWeigh to the nearest 0,1 mg, 50 mg of lasalocid sodium (3.10) into a 100 ml graduated flask, dissolve in acidified methanol (3.8), make up to the mark with the same solvent and mix. This solution must be freshly prepared before use.3.10.2. Lasalocid sodium intermediate standard solution, 50 μg/mlPipette 10,0 ml of stock standard solution (3.10.1) into a 100 ml graduated flask, make up to the mark with acidified methanol (3.8) and mix. This solution must be prepared freshly before use.3.10.3. Calibration solutionsInto a series of 50 ml graduated flasks transfer 1.0, 2.0, 4.0, 5.0 and 10.0 ml of the intermediate standard solution (3.10.2). Make up to the mark with acidified methanol (3.8) and mix. These solutions correspond to 1.0, 2.0, 4.0, 5.0 and 10.0 μg of lasalocid sodium per ml respectively. These solutions must be prepared freshly before use.3.11. Water, HPLC grade4. Apparatus4.1. Ultrasonic bath (or shaking water-bath) with temperature control4.2. Membrane filters, 0,45 μm4.3. HPLC equipment with injection system, suitable for injecting volumes of 20 μl.4.3.1. Liquid chromatographic column 125 mm x 4 mm, reversed-phase C18, 5 μm packing or equivalent4.3.2. Spectrofluorimeter with variable wavelength adjustment of excitation and emission wavelengths5. Procedure5.1. General5.1.1. Blank feedFor the performance of the recovery test (5.1.2) a blank feed should be analysed to check that neither lasalocid sodium nor interfering substances are present. The blank feed should be similar in type to that of the sample and lasalocid sodium or interfering substances should not be detected.5.1.2. Recovery testA recovery test should be carried out by analysing the blank feed which has been fortified by addition of a quantity of lasalocid sodium, similar to that present in the sample. To fortify at a level of 100 mg/kg, transfer 10,0 ml of the stock standard (3.10.1) to a 250 ml conical flask and evaporate the solution to approximately 0,5 ml. Add 50 g of the blank feed, mix thoroughly and leave for 10 minutes mixing again several times before proceeding with the extraction step (5.2).Alternatively, if a blank feed similar in type to that of the sample is not available (see 5.1.1), a recovery test can be performed by means of the standard addition method. In this case the sample to be analysed is fortified with a quantity of lasalocid sodium similar to that already present in the sample. This sample is analysed together with the unfortified sample and the recovery calculated by subtraction.5.2. Extraction5.2.1. FeedingstuffsWeigh to the nearest 0,01 g, from 5 g to 10 g of the sample into a 250 ml conical flask with stopper. Add 100,0 ml of acidified methanol (3.8) by pipette. Stopper loosely and swirl to disperse. Place the flask in an ultrasonic bath (4.1) at approximately 40° C for 20 minutes, then remove and cool to room temperature. Allow to stand for about 1 hour until the suspended matter has settled, then filter an aliquot portion through a 0,45 μm membrane filter (4.2) into a suitable vessel. Proceed to the HPLC determination (5.3).5.2.2. PremixturesWeigh to the nearest 0,001 g about 2 g of the unground premix into a 250 ml graduated flask. Add 100,0 ml of acidified methanol (3.8) and swirl to disperse. Place the flask and contents in an ultrasonic bath (4.1) at approximately 40° C for 20 minutes, then remove and cool to room temperature. Dilute to the mark with acidified methanol (3.8) and mix thoroughly. Allow to stand for one hour until the suspended matter has settled, then filter an aliquot portion through a 0,45 μm membrane filter (4.2). Dilute an appropriate volume of the clear filtrate with acidified methanol (3.8) to produce a final test solution containing about 4 μg/ml of lasalocid sodium. Proceed to the HPLC determination (5.3).5.3. HPLC Determination5.3.1. ParametersThe following conditions are offered for guidance; other conditions may be used, provided they yield equivalent results:>TABLE>Check the stability of the chromatographic system, injecting the calibration solution (3.10.3) containing 4,0 μg/ml several times, until constant peak heights (or areas) and retention times are achieved.5.3.2. Calibration graphInject each calibration solution (3.10.3) several times and determine the mean peak heights (areas) for each concentration. Plot a calibration graph using the mean peak heights (areas) as the ordinates and the corresponding concentrations in μg/ml as the abscissae.5.3.3. Sample solutionInject the sample extracts obtained in 5.2.1 or 5.2.2 several times, using the same volume as taken for the calibration solution and determine the mean peak heights (areas) of the lasalocid sodium peaks.6. Calculation of resultsFrom the mean peak height (area) produced by injection of the sample solution (5.3.3) determine the concentration of lasalocid sodium (μg/ml) by reference to the calibration graph.6.1. FeedingstuffsThe lasalocid sodium content, w (mg/kg) in the sample is given by the following formula:>REFERENCE TO A GRAPHIC>where:ß= lasalocid sodium concentration of the sample solution (5.2.1) in μg/mlV1= volume of the sample extract according to 5.2.1 in ml (i.e. 100)m= mass of the test portion in g6.2. PremixturesThe lasalocid sodium content, w (mg/kg) in the sample is given by the following formula:>REFERENCE TO A GRAPHIC>where:ß= lasalocid sodium concentration of the sample solution (5.2.2) in μg/mlV2= volume of the sample extract according to 5.2.2 in ml (i.e. 250)f= dilution factor according to 5.2.2m= mass of the test portion in g7. Validation of the results7.1. IdentityMethods based on spectrofluorimetry are less subject to interference than those in which UV detection is used. The identity of the analyte can be confirmed by co-chromatography.7.1.1. Co-chromatographyA sample extract (5.2.1 or 5.2.2) is fortified by the addition of an appropriate amount of a calibration solution (3.10.3). The amount of added lasalocid sodium should be similar to the amount of lasalocid sodium found in the sample extract. Only the height of the lasalocid sodium peak should be enhanced to an extent based on the amount of lasalocid sodium added and the dilution of the extract. The peak width, at half height, must be within ± 10 % of the original peak width produced by the unfortified sample extract.7.2. RepeatabilityThe difference between the results of two parallel determinations carried out on the same sample must not exceed:- 15 % relative to the higher value for lasalocid sodium contents from 30 mg/kg to 100 mg/kg;- 15 mg/kg for lasalocid sodium contents from 100 mg/kg to 200 mg/kg;- 7,5 % relative to the higher value for lasalocid sodium contents of more than 200 mg/kg.7.3. RecoveryFor the fortified (blank) feed sample, the recovery should be at least 80 %. For the fortified premixture samples, the recovery should be at least 90 %.8. Results of a collaborative studyA collaborative study(1) was arranged in which 2 premixtures (samples 1 and 2) and 5 feeds (samples 3-7) were analysed by 12 laboratories. Duplicate analyses were performed on each sample. The results are given in the following table:>TABLE>L= number of laboratoriesn= number of single resultsSr= standard deviation of repeatabilitySR= standard deviation of reproducibilityCVr= coefficient of variation of repeatability, %CVR= coefficient of variation of reproducibility, %(1) Analyst, 1995, 120, 2175-2180.