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31965L0065

Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products

Official Journal 022 , 09/02/1965 P. 0369 - 0373 Finnish special edition: Chapter 13 Volume 1 P. 0067  Swedish special edition: Chapter 13 Volume 1 P. 0067  Danish special edition: Series I Chapter 1965-1966 P. 0017  English special edition: Series I Chapter 1965-1966 P. 0024  Greek special edition: Chapter 13 Volume 1 P. 0025  Spanish special edition: Chapter 13 Volume 1 P. 0018  Portuguese special edition Chapter 13 Volume 1 P. 0018

COUNCIL DIRECTIVE  of 26 January 1965  on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products  (65/65/EEC) THE COUNCIL OF THE EUROPEAN ECONOMIC COMMUNITY, Having regard to the Treaty establishing the European Economic Community, and in particular Article 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 the primary purpose of any rules concerning the production and distribution of proprietary medicinal products must be to safeguard public health; Whereas, however, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community; Whereas trade in proprietary medicinal products within the Community is hindered by disparities between certain national provisions, in particular between provisions relating to medicinal products (excluding substances or combinations of substances which are foods, animal feeding-stuffs or toilet preparations) ; and whereas such disparities directly affect the establishment and functioning of the common market; Whereas such hindrances must accordingly be removed ; and whereas this entails approximation of the relevant provisions; Whereas, however, such approximation can only be achieved progressively ; and whereas priority must be given to eliminating the disparities liable to have the greatest effect on the functioning of the common market; HAS ADOPTED THIS DIRECTIVE:    CHAPTER I Definitions and scope Article 1For the purposes of this Directive, the following shall have the meanings hereby assigned to them;  1. Proprietary medicinal product: Any ready-prepared medicinal product placed on the market under a special name and in a special pack. 2. Medicinal product: Any substance or combination of substances presented for treating or preventing disease in human beings or animals. Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product.  (1) OJ No 84, 4.6.1963, p. 1571/63. (2) OJ No 158, 16.10.1964, p. 2508/64.  3. Substance: Any matter irrespective of origin which may be:  - human, e.g. human blood and human blood products; - animal, e.g. micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products, etc; - vegetable, e.g. micro-organisms, plants, parts of plants, vegetable secretions, extracts, etc; - chemical, e.g. elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis. Article 2The provisions of Chapters II to V shall apply only to proprietary medicinal products for human use intended to be placed on the market in Member States.   CHAPTER II Authorisation to place proprietary medicinal products on the market  Article 3No proprietary medicinal product may be placed on the market in a Member State unless an authorisation has been issued by the competent authority of that Member State. Article 4In order to obtain an authorisation to place a proprietary medicinal product on the market as provided for in Article 3, the person responsible for placing that product on the market shall make application to the competent authority of the Member State concerned. The application shall be accompanied by the following particulars and documents:  1. Name or corporate name and permanent address of the person responsible for placing the proprietary product on the market and, where applicable, of the manufacturer. 2. Name of the proprietary product (brand name, or common name together with a trade mark or name of the manufacturer, or scientific name together with a trade mark or name of the manufacturer). 3. Qualitative and quantitative particulars of all the constituents of the proprietary product in usual terminology, but excluding empirical chemical formulae, with mention of the international non-proprietary name recommended by the World Health Organisation where such name exists. 4. Brief description of the method of preparation. 5. Therapeutic indications, contra-indications and side-effects. 6. Posology, pharmaceutical form, method and route of administration and expected shelf life if less than three years. 7. Control methods employed by the manufacturer (analysis and assay of the constituents and of the finished product, special tests, e.g. sterility tests, tests for the presence of pyrogenic substances, the presence of heavy metals, stability tests, biological and toxicity tests). 8. Results of:  - physico-chemical, biological or microbiological tests; - pharmacological and toxicological tests; - clinical trials. However:  (a) a List of published references relating to the pharmacological tests, toxicological tests and clinical trials may be substituted for the relevant test results in the case of:  (i) a proprietary product with an established use, which has been adequately tested on human beings so that its effects, including side-effects, are already known and are included in the published references; (ii) a new proprietary product, in which the combination of active constituents is  identical with that of a known proprietary product with an established use; (iii) a new proprietary product consisting solely of known constituents that have been used in combination in comparable proportions in adequately tested medicinal products with an established use; (b) In the case of a new proprietary product containing known constituents not hitherto used in combination for therapeutic purposes, references to published data may be substituted for the tests of such constituents. 9. One or more specimens or mock-ups of the sales presentation of the proprietary product, together with a package leaflet where one is to be enclosed. 10. A document showing that the manufacturer is authorised in his own country to produce proprietary products. 11. Any authorisation obtained in another Member State or in a third country to place the relevant proprietary product on the market. Article 5The authorisation provided for in Article 3 shall be refused if, after verification of the particulars and documents listed in Article 4, it proves that the proprietary medicinal product is harmful in the normal conditions of use, or that its therapeutic efficacy is lacking or is insufficiently substantiated by the applicant, or that its qualitative and quantitative composition is not as declared. Authorisation shall likewise be refused if the particulars and documents submitted in support of the application do not comply with Article 4. Article 6The competent authorities of Member States may refuse to authorise the placing on the market of a proprietary medicinal product for use as a contraceptive where the sale of proprietary products intended principally for such purposes is prohibited under their laws. Article 7Member States shall take all appropriate measures to ensure that the procedure for granting an authorisation to place a proprietary medicinal product on the market is completed within 120 days of the date of submitting the application. In exceptional cases this time limit may be extended for a further ninety days. The applicant shall be notified of such extension before the expiry of the initial time limit. Article 8Member States shall take all appropriate measures to ensure that the holder of an authorisation furnishes proof that the controls have been carried out on the finished product in accordance with the methods described by the applicant pursuant to item 7 of the second paragraph of Article 4. Article 9Authorisation shall not affect the civil and criminal liability of the manufacturer and, where applicable, of the person responsible for placing the proprietary medicinal product on the market. Article 10Authorisations shall be valid for five years and shall be renewed for five-year periods, on application by the holder within the three months preceding expiry.  CHAPTER III Suspension and revocation of authorisation to market proprietary medicinal products Article 11The competent authorities of the Member States shall suspend or revoke an authorisation to place a proprietary medicinal product on the market where that product proves to be harmful in the normal conditions of use, or where its therapeutic efficacy is lacking, or where its qualitative and quantitative composition is not as declared. Therapeutic efficacy is lacking when it is established that therapeutic results cannot be obtained with the proprietary product. An authorisation shall also be suspended or revoked where the particulars supporting the application as provided for in Article 4 are found to be incorrect, or when the controls on the finished product referred to in Article 8 have not been carried out.  Article 12All decisions taken pursuant to Articles 5, 6 or 11 shall state in detail the reasons on which they are based. A decision shall be notified to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force and of the time limit allowed for the exercise of such remedies. Authorisations to place a proprietary product on the market and decisions to revoke authorisations shall be published by each Member State in the appropriate official publication.  CHAPTER IV Labelling of proprietary medicinal products Article 13The following particulars shall appear on containers and outer packages of proprietary medicinal products:  1. Name of the proprietary product which may be a brand name, or a common name together with a trade mark or name of the manufacturer, or a scientific name together with a trade mark or name of the manufacturer. 2. Next to the name of the proprietary product, a statement of the active constituents expressed qualitatively and quantitatively per dose-unit or as a percentage, according to the pharmaceutical form. The international non-proprietary names recommended by the World Health Organisation shall be used wherever they exist. 3. Reference number for production identification (manufacturer's batch number). 4. Number of the authorisation to place the proprietary product on the market. 5. Name or corporate name and permanent address of the person responsible for placing the proprietary product on the market and, where applicable, of the manufacturer. 6. Method of administration. 7. Expiry date for proprietary products with a shelf life of less than three years. 8. Special storage precautions, if any. The pharmaceutical form and the contents by weight, by volume or by number of dose-units need only be shown on the outer packages. Article 14In the case of ampoules, the particulars required under the first paragraph of Article 13 shall be given on the outer packages. However, on the actual containers only the following particulars are required:  - name of the proprietary medicinal product; - quantity of active constituents; - route of administration; - expiry date. Article 15As regards small single-dose containers, other than ampoules, on which it is impossible to give the particulars mentioned in Article 14, the requirements of Article 13 shall apply only to the outer package. Article 16In the case of narcotics, in addition to the particulars mentioned in Article 13, a special sign consisting of a double red line shall appear on both the outer package and the container. Article 17Where there is no outer package, the particulars which should feature on such a package pursuant to the preceding Articles shall be shown on the container. Article 18The particulars mentioned in items, 6, 7 and 8 of the first paragraph of Article 13 shall appear on the outer package and on the container of proprietary medicinal products in the language or languages of the country where they are being placed on the market. Article 19The provisions of this Chapter shall not prevent the particulars required by rules other than those to which this Directive relates from being given on outer packages or on containers.  Article 20Where the provisions of this Chapter are not observed and an order addressed to the person concerned has remained without effect, the competent authorities of the Member States may suspend or revoke the authorisation to place the proprietary medicinal product on the market. All decisions taken in pursuance of the preceding paragraph shall state in detail the reasons on which they are based. A decision shall be notified to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force and of the time limit allowed for the exercise of such remedies.    CHAPTER V General and final provisions  Article 21An authorisation to market a proprietary medicinal product shall not be refused, suspended or revoked except on the grounds set out in this Directive. Article 22Member States shall put into force the measures needed in order to comply with this Directive within eighteen months of its notification and shall inform the Commission forthwith. Article 23Member States shall ensure that they communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 24In the five years following the notification mentioned in Article 22, the rules for which provision is made in this Directive shall be applied progressively to proprietary medicinal products covered by an authorisation to place on the market by virtue of previous provisions. Article 25This Directive is addressed to the Member States. Done at Brussels, 26 January 1965. For the Council The President M. COUVE DE MURVILLE


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31985L0339

Council Directive 85/339/EEC of 27 June 1985 on containers of liquids for human consumption

Official Journal L 176 , 06/07/1985 P. 0018 - 0021 Finnish special edition: Chapter 15 Volume 6 P. 0235  Spanish special edition: Chapter 15 Volume 6 P. 0022  Swedish special edition: Chapter 15 Volume 6 P. 0235  Portuguese special edition Chapter 15 Volume 6 P. 0022

*****COUNCIL  DIRECTIVE  of 27 June 1985  on containers of liquids for human consumption  (85/339/EEC)  THE COUNCIL OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 235 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas the action programmes of the European Communities on the environment of 1973 (4), 1977 (5) and 1983 (6) emphasize inter alia the importance of recycling or re-using the various materials contained in waste;  Whereas Article 3 of Council Directive 75/442/EEC of 15 July 1975 on waste (7) calls for the implementation of appropriate steps to encourage the prevention, recycling and processing of waste;  Whereas containers of liquids for human consumption are a source of waste;  Whereas the environmental impact of used containers should be reduced and a reduction in the consumption of energy and raw materials encouraged;  Whereas, in order to attain these objectives, Member States should draw up programmes for reducing the tonnage and/or volume of containers of liquids for human consumption in household waste to be finally disposed of;  Whereas, within the framework of these programmes, Member States should, either by legislative or administrative means or by voluntary agreements, take measures relating inter alia to consumer education, refilling and recycling of containers and technological innovation;  Whereas the measures taken by Member States should, where appropriate, take account of economic, industrial and market conditions;  Whereas the measures taken by the Member States should in particular likewise take account of public health requirements; whereas to that end, pending Community provisions on the matter, Member States may introduce or maintain measures on the manufacture of new containers;  Whereas the measures taken by Member States to comply with this Directive must comply with the provisions of the Treaty, and in particular with those concerning the free movement of goods;  Whereas the Commission should be notified of such measures at the draft stage so that it can examine them in the light of existing agreements and, where appropriate, ask Member States to suspend the introduction of such measures;  Whereas, since the Treaty has not provided the powers required for this end, recourse should be had to Article 235 thereof,  HAS ADOPTED THIS DIRECTIVE:  Article 1  The purpose of this Directive is to provide for a series of measures relating to the production, marketing, use, recycling and refilling of containers of liquids for human consumption and to the disposal of used containers, in order to reduce the impact of the latter on the environment and to encourage a reduction in the consumption of energy and raw materials in this field.  Article 2  For the purposes of this Directive:  (a) 'liquids for human consumption' means the liquids for human consumption listed in Annex I;  (b) 'container' means any bottle, can, jar, carton or any other type of sealed container (excluding barrels and casks) which contains a liquid for human consumption and is made of glass, metal, plastic, paper or any other material;  (c) 'refillable container' means any container which is intended to be recovered for refilling after use;  (d) 'deposit system' means a system where the buyer pays the seller a sum of money which is reimbursed when the container is returned;  (e) 'recycling of containers' means the manufacture of new containers or other products from used containers or their use as fuel.  Article 3  1. In pursuance of the objectives referred to in Article 1, Member States shall draw up programmes for reducing the tonnage and/or volume of containers of liquids for human consumption in household waste to be finally disposed of.  2. Programmes shall be drawn up for the first time for a period commencing on 1 January 1987 and shall be communicated to the Commission before that date.  3. These programmes shall be revised and updated regularly, at least every four years, taking into account in particular technical progress and changing economic circumstances.  4. These programmes shall take account of the repercussions of the measures envisaged on energy consumption, with a view to achieving as far as possible a reduction in overall energy consumption.  Article 4  1. Within the framework of the programmes referred to in Article 3 and with due regard for the provisions of the Treaty on the free movement of goods, Member States shall, either by legislative or administrative means or by voluntary agreements, take measures designed inter alia:  (a) to develop consumer education in the advantages of using refillable containers, recycling containers and eliminating used containers from household waste;  (b) to facilitate the refilling and/or recycling of containers of liquids for human consumption;  (c) as regards non-refillable containers:  - to promote the selective collection of containers,  - to develop effective processes for retrieving containers from household waste,  - to extend the outlets for materials recovered from containers,  in so far as this is economically feasible;  (d) to encourage the technical development and placing on the market of new types of container, with the aim in particular of reducing the consumption of raw materials, facilitating recycling and the final disposal of container waste and achieving overall energy savings;  (e) to maintain and, where possible, increase the proportion of refilled and/or recycled containers and/or to decrease the proportion of non-recycled or non-refillable containers where the conditions of industrial activity and the market so permit.  2. In the context of the measures referred to in paragraph 1, and with due regard for the provisions of the Treaty and other Community provisions on the subject, account should be taken in particular of health factors, including considerations relating to the technical characteristics of the materials used, the necessary safety requirements and industrial and commercial property rights.  To that end, and pending Community regulations on the matter, Member States may, for health reasons, introduce measures or maintain measures in force to exclude the use of certain materials or substances recovered from used containers in the manufacture of new containers.  Article 5  1. Member States shall take steps to ensure that a clear indication is given on new refillable containers offered for sale, either on the container itself or on the label, that the containers concerned are refillable. The indication will be applied in such a manner as to be easily visible, clearly legible and durable, and to remain intact when the container is opened.  This obligation shall not apply for a period of 10 years, from the date of notification of this Directive, to existing systems using refillable glass bottles on which certain information is marked indelibly.  Where, in particular regions, sales of liquids for human consumption, for example milk or cream, have been made for a considerable period using well-established systems for the recovery of glass bottles, it shall not be necessary to indicate on the containers that they are refillable.  2. Where a deposit system is used, Member States shall take appropriate steps to ensure that the consumer is clearly informed of the amount of the deposit. Article 6  Every four years Member States shall send reports to the Commission on the measures taken under the programmes referred to in Article 3 and the results achieved, in accordance with the guidelines in Annex II.  Article 7  1. Member States shall notify the Commission of all the laws, regulations and administrative provisions enacted and of all the voluntary agreements referred to in Article 4 (1), whether national or sectoral in scope, which have been entered into for the purposes of implementing this Directive.  2. Without prejudice to Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (1), before adopting such measures, Member States shall notify the draft texts to the Commission in order to permit the latter to examine them in the light of existing agreements and, where appropriate, to ask Member States to suspend their adoption.  Article 8  Member States shall take the steps necessary to comply with this Directive within 24 months of its notification (2).  Article 9  This Directive is addressed to the Member States.  Done at Luxembourg, 27 June 1985.  For the Council  The President  A. BIONDI  (1) OJ No C 204, 13. 8. 1981, p. 6.  (2) OJ No C 242, 12. 9. 1983, p. 92.  (3) OJ No C 343, 31. 12. 1981, p. 23.  (4) OJ No C 112, 20. 12. 1973, p. 1.  (5) OJ No C 139, 13. 6. 1977, p. 33.  (6) OJ No C 46, 17. 2. 1983, p. 1.  (7) OJ No L 194, 25. 7. 1975, p. 39.  (1) OJ No L 109, 26. 4. 1983, p. 8.  (2) This Directive was notified to the Member States on 3 July 1985.  ANNEX  I  LIQUIDS FOR HUMAN CONSUMPTION REFERRED TO IN ARTICLE 2  1. Milk and liquid milk products, whether or not flavoured, with the exception of yoghurt and kefir.  2. Edible oils (1).  3. Fruit or vegetable juices and fruit nectar.  4. Natural spa water, spring water, aerated water and table water.  5. Non-alcoholic refreshing drinks.  6. Beer, including non-alcoholic beer.  7. Wine made from fresh grapes; grape must with fermentation arrested by the addition of alcohol.  8. Vermouths, and other wines made from fresh grapes flavoured with aromatic plants or extracts.  9. Cider, perry, mead and other fermented beverages.  10. Ethyl alcohol, not denatured, with an alcoholic strength of less than 80% by volume; spirits, liqueurs and other spirituous beverages; compound alcoholic preparations for the manufacture of beverages.  11. Fermentation vinegar and diluted synthetic acetic acid (1).  ANNEX II  GUIDELINES FOR THE REPORTS TO BE SENT TO THE COMMISSION PURSUANT TO ARTICLE 6  The information to be sent to the Commission pursuant to Article 6 shall include, as far as possible, particulars of:  - the quantities of liquids for human consumption bottled separately for each type of liquid and container used,  - the quantities of reused and recycled containers, separately for each type of packaging material,  - the quantities of containers which have been neither reused nor recycled, separately for each type of packaging material,  - data on the energy consumed in the manufacture and use of containers,  - a description of the methods used to gather and process the above information.  (1) Most containers used for oil and vinegar are unsuitable for refilling but may be suitable for recycling.


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31993L0118

Council Directive 93/118/EEC of 22 December 1993 amending Directive 85/73/EEC on the financing of health inspections and controls of fresh meat and poultrymeat

Official Journal L 340 , 31/12/1993 P. 0015 - 0020 Finnish special edition: Chapter 3 Volume 55 P. 0188  Swedish special edition: Chapter 3 Volume 55 P. 0188

COUNCIL DIRECTIVE  93/118/ECof 22 December 1993amending Directive 85/73/EEC on the financing of health inspections  and controls of fresh meat and poultrymeatTHE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 43  thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas animal products are included in the list of products contained in Annex II to the Treaty;  whereas the marketing of those products constitutes a significant source of income for a large part  of the agricultural population; Whereas Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in  intra-Community trade with a view to the completion of the internal market (4), laid down in  particular the requirements for veterinary checks to be carried out in the Member State of dispatch  for a large number of animal products; Whereas Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the  organization of veterinary checks on products entering the Community from third countries (5) laid  down in particular the requirements for checks to be carried out on animal products from third  countries; Whereas Directive 85/73/EEC (6) laid down harmonized rules on the financing of health inspections  and controls in relation to fresh meat of certain animal species; whereas that Directive lays down  in particular that a fee is to be collected for inspections and controls; Whereas Directive 85/73/EEC should be amended to take account of the new provisions concerning  controls; Whereas the principles laid down by Directive 85/73/EEC, and in particular the principle of  charging fees, should be extended; whereas such an extension is justified by the concern to ensure  that the control arrangements operate effectively and distortions of competition are avoided; Whereas the necessary rules should now be laid down to ensure the financing of the checks on meat  covered by Directives 64/433/EEC (7), 71/118/EEC (8) and 72/462/EEC (9); Whereas for the other products of animal origin detailed rules will be established at a later date  taking account of the specific nature of the products to be checked, the nature of the checks to be  made and the advisability, having regard to the rules of competition, of setting a Community fee; Whereas the Community provisions on the matter must be presented homogeneously, HAS ADOPTED THIS DIRECTIVE: Article 1Directive 85/73/EEC is hereby amended as follows: 1. The title shall be replaced by the following: 'Council Directive 85/73/EEC on the financing of veterinary inspections and controls of animal  products covered by Annex A to Directive 89/662/EEC and by Directive 90/675/EEC'. 2. Article 1 shall read as follows: 'Article 11. The Member States shall ensure- the collection of a Community fee for the costs  occasioned by health inspections and controls on the meat referred to in Directives 64/433/EEC,  72/462/EEC and 71/118/EEC, including the expenses entailed by the checks referred to in Directive  86/469/EEC, as well as those resulting from monitoring the rules laid down in Directive 93/118/EC  (*), - the financing of: - other veterinary inspections and controls laid down for the products referred to in the  Directives listed in Annex A to Directive 89/662/EEC, - the controls provided for by Directive 90/675/EEC for products of animal origin other than the  meat referred to in the first indent, including controls to detect the presence of residues. 2. The fees referred to in paragraph 1 shall be fixed so as to cover the costs incurred by the  competent authority for- salary costs, including social-security costs, - administrative costs, which may include the expenditure required for in-service training of  inspectorsfor carrying out the controls and inspections referred to in paragraph 1. 3. Any direct or indirect refund of the fees provided for by this Directive shall be prohibited. 3. Articles 2, 2a, and 3 shall be replaced by the following Articles: 'Article 21. The Member States shall ensure, for the purpose of financing the controls carried out  pursuant to the Directives referred to in Article 1 by the competent authorities and for that  purpose only, the collection- for the types of meat referred to in Directives 64/433/EEC,  71/118/EEC and 72/462/EEC, with effect from 1 January 1994, of the Community fees following the  procedures laid down in the Annex, - from a date to be set at the time of adoption of the decisions provided for by Article 6, of a  Community fee for the controls carried out on products of animal origin referred to in Article 1  (1), second indent. 2. Pending the decisions referred to in the second indent of paragraph 1, the Member States may  collect national fees with due regard to the relevant principles governing the setting of Community  fees. 3. Member States shall be authorized to collect an amount exceeding the level or levels of the  Community fees, provided that the total fee collected by each Member State is not greater than the  actual figure for inspection costs. 4. The Community fees shall replace all other health inspection charges or fees levied by the  national, regional or local authorities of the Member States for the inspections and controls  referred to in Article 1 and the certification thereof. However, until 31 December 1995, the Member  States shall be authorized to collect registration costs for establishments approved in accordance  with the rules referred to in Annex A to Directive 89/662/EEC. This Directive shall not preclude Member States from collecting a fee for combating epizootic  diseases. 5. The Member States shall forward information - initially two years after the introduction of the  new system and subsequently at the Commission's request - to the Commission concerning the  distribution and use of the fees and must be able to justify their method of calculation. Article 31. As part of the checks provided for in Article 12 of Directive 64/433/EEC, Article 10  of Directive 71/118/EEC and Article 20 of Directive 90/675/EEC, the Commission may, by random spot  checks, verify whether the provisions of this Directive are being applied. 2. Where a Member State considers that the controls in another Member State are carried out in such  a way that the fees provided for in this Directive do not correspond to the actual costs of the  controls, it shall have recourse to the relevant provisions of Directive 89/608/EEC and, in  particular, Articles 10 and 11 thereof. Article 4The fees shall be payable by the operator or owner of the establishment carrying out the  operations referred to in the Directives listed in Annex A to Directive 89/662/EEC, who shall have  the option of passing on the cost of the fee for the operation concerned to the natural or legal  person on whose behalf the said operations are carried out. For imports the fees shall be payable  by the importer or the customs agent acting for the importer. Article 5The rate of conversion into national currency of the amounts in ecus specified in this  Directive shall be that published annually on the first working day of the month of September in  the C series of the Official Journal of the European Communities. This rate shall apply from 1 January of the following year. However, the Member States shall apply for 1994 the rate of conversion applicable on 1 September  1992 and, for 1995, the average of the conversion rates published in accordance with the first  paragraph for the last three years. Article 61. The Council, acting by a qualified majority on a proposal from the Commission, may  supplement this Directive with specific Annexes, so as to set the standard levels of the Community  fees and determine the rules and principles for the application of this Directive, including  exceptions to be made, as required for the implementation of the checks laid down in the Directives  referred to in Annex A to Directive 89/662/EEC and in Directive 90/675/EEC. 2. The Annex to this Directive may be amended or supplemented by the procedure provided for in  paragraph 1. 3. Before 1 January 1996, the Council shall review this Directive on the basis of a report from the  Commission, accompanied by proposals where appropriate. Article 7The Member States shall inform the Commission- of the conversion rates adopted each year  in accordance with Article 5, - of the place or places where fees are charged, in accordance with Chapter I.6 of the Annex,  giving any necessary explanations. Article 81. Greece shall be authorized to derogate from the principles laid down in this Directive  where, because of geographical characteristics, the costs of collecting a fee in geographically  remote regions are greater than the yield from the fee. The Greek authorities shall inform the Commission of the territorial extent of the derogations  granted. The information shall be accompanied by any necessary explanations. 2. In the case of other outermost regions, other Member States may be authorized, in accordance  with the procedure provided for in Article 18 of Directive 89/662/EEC, to benefit from the same  derogations.'4. The existing Articles 4 and 5 shall become Articles 9 and 10 respectively. 5. The Annex attached to this Directive is hereby added. Article 2Decision 88/408/EEC is hereby repealed with effect from 1 January 1994. Article 31. Member States shall bring into force the laws, regulations and administrative  provisions necessary to comply with this Directive not later than 31 December 1993 as regards the  requirements in the Annex and in Article 5, and not later than 31 December 1994 as regards the  other provisions. Portugal shall be allowed an additional period of one year to comply with the new provisions in  Chapter I of the Annex. Member States shall forthwith inform the Commission of the provisions adopted. When Member States adopt those provisions, they shall contain a reference to this Directive or be  accompanied by such reference on the occasion of their official publication. The methods of making  such a reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic  law which they adopt in the field governed by this Directive. Article 4This Directive is addressed to the Member States. Done at Brussels, 22 December 1993. For the CouncilThe PresidentJ.-M. DEHOUSSE(1) OJ No C 325, 14. 12. 1991, p.  21. (2) OJ No C 94, 13. 4. 1992, p. 326. (3) OJ No C 106, 27. 4. 1992, p. 17. (4) OJ No L 395, 30. 12. 1989, p. 13. Directive last amended by Directive 92/118/EEC (OJ No L 62,  15. 3. 1993, p. 49). (5) OJ No L 373, 31. 12. 1990, p. 1. Directive last amended by Directive 92/118/EEC (OJ No L 62,  15. 3. 1993, p. 49). (6) OJ No L 32, 5. 2. 1985, p. 14. Directive amended by Directive 88/409/EEC (OJ No L 194, 22. 7.  1988, p. 28). (7) OJ No 121, 29. 7. 1964, p. 2012/64. (8) OJ No L 55, 8. 3. 1971, p. 23. (9) OJ No L 302, 31. 12. 1972, p. 28. (*) OJ No L 340, 31. 12. 1993, p. 15'.  ANNEX 'ANNEX FEES APPLYING TO MEAT COVERED BY DIRECTIVES 64/433/EEC, 71/118/EEC AND  72/462/EEC CHAPTER I Meat covered by Directives 64/433/EEC and 71/118/EEC The fee referred to in  Article 1 (1), first indent, is fixed in accordance with Article 1 (2) as follows: 1. Without prejudice to the application of points 4 and 5, Member States will collect for  inspection costs relating to slaughter- the following standard amounts: (a) beef and veal- adult bovine animals: ECU 4,75 per animal, - young bovine animals: ECU 2,5 per animal; (b) solipeds/equidae: ECU 4,4 per animal; (c) pigs: ECU 1,3 per animal; (d) sheepmeat and goatmeat: animals of a carcase weight(i) of less than 12 kilograms: ECU 0,175  per animal; (ii) of between 12 and 18 kilograms: ECU 0,35 per animal; (iii) of more than 18 kilograms: ECU 0,5 per animal. Pending a review of the rules governing inspection for lambs, goats and piglets of less than 12  kilograms, and until 31 December 1995 at the latest, the Member States may collect an amount  corresponding to the actual cost of inspection for the inspection of those slaughtered animals; (e) Until 31 December 1995, the minimum amount to be collected for the ante-mortem and post-mortem  inspection provided for in Directive 71/118/EEC shall be fixed: (i) either at a standard rate as follows: - for broilers, other young poultry for fattening weighing less than two kilograms and for cast  hens: ECU 0,01 per animal, - other young poultry for fattening of a carcase weight of more than two kilograms: ECU 0,02 per  animal, - other heavy adult poultry weighing more than five kilograms: ECU 0,04 per animal; (ii) or, where a Member State decides not to make the distinction between categories of poultry as  in (i), at ECU 0,03 per bird; - a share of the fees for(a) administrative costs may not be lower than ECU 0,725 per tonne; (b) examination for the presence of residues may not be lower than ECU 1,35 per tonne. 2. The controls and inspections connected with the cutting operations referred to in Article 3  (1)(B) of Directive 64/433/EEC and Article 3 (1)(B) of Directive 71/118/EEC shall be covered(a)  either at a standard rate by the addition of a standard amount of ECU 3 per tonne on meat entering  a cutting plant. This amount is added to the amounts referred to in point 1 above; (b) or by collecting the actual costs of inspection per hour worked, any hour started being counted  as an hour worked. Where the cutting operations are carried out in the establishment where the meat is obtained, the  amounts laid down in the first subparagraph may be reduced by up to 55 %. 3. Member States shall collect an amount corresponding to the actual expenditure necessary for  controls or inspections of the meat being stored, pursuant to Article 3 (1)(D) of Directive  64/433/EEC and Article 3 (1)(C) of Directive 71/118/EEC. The rules of application of this point may be fixed under the procedure provided for in Article 16  of Directive 64/433/EEC or Article 21 of Directive 71/118/EEC, with a view in particular to  settling the cases of intervention meat and meat subject to short-term storage in successive  coldstores. 4. In order to cover increased costs, Member States may, (a) increase the standard amounts for fees pursuant to points 1 and 2(a) for individual  establishments; This would be subject, for example, to one or more of the following conditions (apart from the  condition laid down in 5(a)): - higher inspection costs due to a particular lack of uniformity in the animals for slaughter from  the point of view of age, size, weight and state of health, - longer waiting and otherwise non-productive periods for inspection staff owing to inadequate  advance planning by the establishment of animal deliveries or technical inadequacies or failures,  for example in older establishments, - frequent delays in the slaughtering process, e.g. as a result of insufficient slaughter staff and  hence under-employment of inspection staff, - higher costs due to special travelling times, - more time taken up on inspections due to frequently changing slaughter periods beyond the control  of inspection staff, - frequent interruptions in the slaughtering process to meet cleaning and disinfecting  requirements; - inspections of animals which, at the request of the owner, are slaughtered outside normal  slaughtering hours. The amount of the increases in the central standard rate for fees shall depend on the level of the  costs to be covered; (b) or collect a special fee covering actual costs. 5. Member States in which salary costs, the structure of establishments and the relationship  between veterinarians and inspectors diverge from the Community average taken as a basis for  calculation of the standard amounts fixed in points 1 and 2(a) may exceptionally reduce them to  meet the real costs of inspection: (a) in general, where there are substantial differences in the cost of living and salary costs; (b) for individual establishments, where the following conditions are met: - a minimum daily slaughter rate must enable the deployment of the relevant inspection staff to be  planned in advance, - the number of slaughtered animals must be constant, so that animal deliveries may be planned in  advance thus enabling rational use to be made of the inspection staff, - strict organization and planning must prevail within the establishment together with a rapid  slaughter rate and optimum use of inspection staff, - there must be no waiting or otherwise non-productive periods for inspection staff, - the animals for slaughter must so far as possible be uniform in age, size, weight and state of  health. In no case should the application of these exemptions result in reductions of more than 55 % of the  levels indicated in point 1. 6. The fees referred to in points 1 to 4 shall be collected, as appropriate, at the slaughterhouse,  cutting plant or cold store. By way of exception to the first paragraph, in the case of establishments carrying out more than  one operation and of chains of production covering more than one operation, the Member States may  collect a total aggregate fee including the various amounts simultaneously and at a single  location. However, if the fee collected at the slaughterhouse covers the whole of the inspection costs  referred to in the first paragraph, the Member States shall not collect any fee at the  cutting-plant or the cold store. CHAPTER II Meat falling under Directive 72/462/EEC 1. The fee referred to in the first indent of  Article 1 (1) is fixed in accordance with Article 1 (2) at the minimum standard level of ECU 5 per  tonne, with a minimum amount of ECU 30 per consignment; that minimum is not however charged in the  case of small consignments imported in cross-border trade. However, Member States may exceptionally increase this amount to meet real costs. 2. Until 1 July 1994 Member States may however continue to collect a reduced amount for third  country meat to which on 1 July 1993 they applied a reduced frequency of controls. This reduction  may not exceed 55 % of the standard level referred to in point 1. 3. When the decisions provided for in Article 8 (3) of Directive 90/675/EEC are adopted and under  the same procedure, the amounts laid down in point 1 may be adapted, taking account of the  reduction in the frequency of controls decided on. When taking these decisions the Commission will take account in particular of the guarantees given  by the third countries concerning acceptance of the principle of regionalization and of the other  Community principles. 4. As from 1 July 1994, in the absence of a decision in accordance with point 3, the Member States  shall apply an amount reduced in line with the reduction in frequency of controls decided on within  the framework of any agreement the Community has concluded in that respect with a third country or,  in the absence of any such agreement, the amounts referred to in point 1. 5. The fee referred to in point 1 is payable by the importer and collected at the customs office  responsible for the border inspection post. 6. Member States may allocate part of the yield of the fees provided for in this Chapter to a  health solidarity fund designed to strengthen the veterinary services to allow them to react more  effectively to any appearance of an exotic disease.'


title: Commission Directive 2014/43/EU of 18 March 2014 amending Annexes I, II and III to Directive 2000/25/EC of the European Parliament and of the Council on action to be taken against the emission of gaseous and particulate pollutants by engines intended to power agricultural or forestry tractors  Text with EEA relevance

text:
               20.3.2014

               EN

               Official Journal of the European Union

               L 82/12

      COMMISSION DIRECTIVE 2014/43/EU
   of 18 March 2014
   amending Annexes I, II and III to Directive 2000/25/EC of the European Parliament and of the Council on action to be taken against the emission of gaseous and particulate pollutants by engines intended to power agricultural or forestry tractors
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2000/25/EC of the European Parliament and of the Council of 22 May 2000 on action to be taken against the emission of gaseous and particulate pollutants by engines intended to power agricultural or forestry tractors and amending Council Directive 74/150/EEC (1) and in particular Article 7 thereof,
   Whereas:

               (1)

               Directive 2000/25/EC lays down the limit values for emissions of gaseous and particulate pollutants to be applied in successive stages, and the test procedure for internal combustion engines intended to power agricultural or forestry tractors by reference to the provisions of Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery (2).

               (2)

               Technical progress requires rapid adaptation of the technical requirements set out in the Annexes to Directive 97/68/EC and therefore that Directive has been amended several times. It is therefore necessary to align Directive 2000/25/EC with the provisions of Directive 97/68/EC as amended.

               (3)

               Annex XII to Directive 97/68/EC has been amended by Commission Directive 2012/46/EU (3) in order to introduce new alternative type-approvals according to technical progress at the UNECE level and so as to ensure international harmonisation with respect to alternative type-approval procedures. Those alternative type-approval provisions should therefore be introduced into Directive 2000/25/EC. In addition, it is necessary to update the references to Regulations No 49 and No 96 of the United Nations Economic Commission for Europe (UNECE) to ensure that they correspond to the amendments to Directive 97/68/EC with respect to the recognition of alternative type-approvals for engines intended to power agricultural and forestry tractors.

               (4)

               Annexes I, II and III to Directive 2000/25/EC should therefore be amended accordingly.

               (5)

               The measures provided for in this Directive are in accordance with the opinion of the Committee established in Article 20 of Directive 2003/37/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes I, II and III to Directive 2000/25/EC are amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by the 1 January 2015 at the latest. They shall communicate to the Commission the relevant text of those provisions forthwith.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 18 March 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 173, 12.7.2000, p. 1.

      (2)  OJ L 59, 27.2.1998, p. 1.

      (3)  OJ L 353, 21.12.2012, p. 80.

      ANNEX
      Annexes I, II and III to Directive 2000/25/EC are amended as follows:

                  (1)

                  Annex I is amended as follows:

                              (a)

                              Section 3 is replaced by the following:
                              ‘3.   SPECIFICATIONS AND TESTS
                              The provisions of Annex I, Sections 4, 8 and 9, Appendices 1 and 2, and Annexes III, IV and V to Directive 97/68/EC shall apply.’;

                              (b)

                              Appendix 1 is amended as follows:

                                          (i)

                                          Section 2.2 is replaced by the following:
                                          ‘2.2.   Measures taken against air pollution
                                          2.2.1.   Device for recycling crankcase gases: yes/no (1) …
                                          2.2.2.   Additional anti-pollution devices (if any, and if not covered by another heading)
                                          2.2.2.1.   Catalytic converter: yes/no (1)
                                          2.2.2.1.1.   Make(s): …
                                          2.2.2.1.2.   Type(s): …
                                          2.2.2.1.3.   Number of catalytic converters and elements …
                                          2.2.2.1.4.   Dimensions- and volume of the catalytic converter(s): …
                                          2.2.2.1.5.   Type of catalytic action: …
                                          2.2.2.1.6.   Total charge of precious metals: …
                                          2.2.2.1.7.   Relative concentration: …
                                          2.2.2.1.8.   Substrate (structure and material): …
                                          2.2.2.1.9.   Cell density: …
                                          2.2.2.1.10.   Type of casing for the catalytic converter(s): …
                                          2.2.2.1.11.   Location of the catalytic converter(s) (place(s) and maximum/minimum distance(s) from engine): …
                                          2.2.2.1.12.   Normal operating range (K): …
                                          2.2.2.1.13.   Consumable reagent (where appropriate): …
                                          2.2.2.1.13.1.   Type and concentration of reagent needed for catalytic action: …
                                          2.2.2.1.13.2.   Normal operational temperature range of reagent: …
                                          2.2.2.1.13.3.   International standard (where appropriate): …
                                          2.2.2.1.14.   NOx sensor: yes/no (1)
                                          2.2.2.2.   Oxygen sensor: yes/no (1)
                                          2.2.2.2.1.   Make(s): …
                                          2.2.2.2.2.   Type: …
                                          2.2.2.2.3.   Location: …
                                          2.2.2.3.   Air injection: yes/no (1)
                                          2.2.2.3.1.   Type (pulse air, air pump, etc.): …
                                          2.2.2.4.   EGR: yes/no (1)
                                          2.2.2.4.1.   Characteristics (cooled/uncooled, high pressure/low pressure, etc.): …
                                          2.2.2.5.   Particulate trap: yes/no (1)
                                          2.2.2.5.1.   Dimensions and capacity of the particulate trap: …
                                          2.2.2.5.2.   Type and design of the particulate trap: …
                                          2.2.2.5.3.   Location (place(s) and maximum/minimum distance(s) from engine): …
                                          2.2.2.5.4.   Method or system of regeneration, description and/or drawing: …
                                          2.2.2.5.5.   Normal operating temperature (K) and pressure (kPa) range: …
                                          2.2.2.6.   Other systems: yes/no (1)
                                          2.2.2.6.1.   Description and operation: …’;

                                          (ii)

                                          Section 2.4 is replaced by the following:
                                          ‘2.4.   Valve timing
                                          2.4.1.   Maximum lift and angles of opening and closing in relation to dead centres or equivalent data: …
                                          2.4.2.   Reference and/or setting ranges (1)
                                          2.4.3.   Variable valve timing system (if applicable and where intake and/or exhaust)
                                          2.4.3.1.   Type: continuous or on/off (1)
                                          2.4.3.2.   Cam phase shift angle: …’;

                                          (iii)

                                          in Section 3.1.2, the table is replaced by the following:

                                                      ‘Parent engine (1)

                                                      Engines within family (2)

                                                      Engine type

                                                      No of cylinders

                                                      Rated speed (min-1)

                                                      Fuel delivery per stroke (mm3) for diesel engines, fuel flow (g/h) for petrol engines, at rated net power

                                                      Rated net power (kW)

                                                      Maximum power speed (min-1)

                                                      Maximum net power (kW)

                                                      Maximum torque speed (min-1)

                                                      Fuel delivery per stroke (mm3) for diesel engines, fuel flow (g/h) for petrol engines, at maximum torque

                                                      Maximum torque (Nm)

                                                      Low idle speed (min-1)

                                                      Cylinder displacement (in % of parent engine)

                                                      100

                                          (iv)

                                          Section 4.2 is replaced by the following:
                                          ‘4.2.   Measures taken against air pollution
                                          4.2.1.   Device for recycling crankcase gases: yes/no (1) …
                                          4.2.2.   Additional anti-pollution devices (if any, and if not covered by another heading)
                                          4.2.2.1.   Catalytic converter: yes/no (1)
                                          4.2.2.1.1.   Make(s): …
                                          4.2.2.1.2.   Type(s): …
                                          4.2.2.1.3.   Number of catalytic converters and elements …
                                          4.2.2.1.4.   Dimensions- and volume of the catalytic converter(s): …
                                          4.2.2.1.5.   Type of catalytic action: …
                                          4.2.2.1.6.   Total charge of precious metals: …
                                          4.2.2.1.7.   Relative concentration: …
                                          4.2.2.1.8.   Substrate (structure and material): …
                                          4.2.2.1.9.   Cell density: …
                                          4.2.2.1.10.   Type of casing for the catalytic converter(s): …
                                          4.2.2.1.11.   Location of the catalytic converter(s) (place(s) and maximum/minimum distance(s) from engine): …
                                          4.2.2.1.12.   Normal operating range (K): …
                                          4.2.2.1.13.   Consumable reagent (where appropriate): …
                                          4.2.2.1.13.1.   Type and concentration of reagent needed for catalytic action: …
                                          4.2.2.1.13.2.   Normal operational temperature range of reagent: …
                                          4.2.2.1.13.3.   International standard (where appropriate): …
                                          4.2.2.1.14.   NOx sensor: yes/no (1)
                                          4.2.2.2.   Oxygen sensor: yes/no (1)
                                          4.2.2.2.1.   Make(s): …
                                          4.2.2.2.2.   Type: …
                                          4.2.2.2.3.   Location: …
                                          4.2.2.3.   Air injection: yes/no (1)
                                          4.2.2.3.1.   Type (pulse air, air pump, etc.): …
                                          4.2.2.4.   EGR: yes/no (1)
                                          4.2.2.4.1.   Characteristics (cooled/uncooled, high pressure/low pressure, etc.): …
                                          4.2.2.5.   Particulate trap: yes/no (1)
                                          4.2.2.5.1.   Dimensions and capacity of the particulate trap: …
                                          4.2.2.5.2.   Type and design of the particulate trap: …
                                          4.2.2.5.3.   Location (place(s) and maximum/minimum distance(s) from engine): …
                                          4.2.2.5.4.   Method or system of regeneration, description and/or drawing: …
                                          4.2.2.5.5.   Normal operating temperature (K) and pressure (kPa) range: …
                                          4.2.2.6.   Other systems: yes/no (1)
                                          4.2.2.6.1.   Description and operation: …’;

                                          (v)

                                          Section 4.4 is replaced by the following
                                          ‘4.4.   Valve timing
                                          4.4.1.   Maximum lift and angles of opening and closing in relation to dead centres or equivalent data: …
                                          4.4.2.   Reference and/or setting ranges (1): …
                                          4.4.3.   Variable valve timing system (if applicable and where intake and/or exhaust)
                                          4.4.3.1.   Type: continuous or on/off (3)

                                          4.4.3.2.   Cam phase shift angle: …

                              (c)

                              Appendix 2 is amended as follows:

                                          (i)

                                          Section 2.4 is replaced by the following:
                                          ‘2.4.   Emission results of the engine/parent engine (1)
                                          2.4.1.   Information concerning the conduct of the NRSC test
                                          Deterioration Factor (DF): calculated/fixed (1)
                                          Specify the DF values and the emission results in the following table:

                                                      NRSC test

                                                      DF mult/add (1)

                                                      CO

                                                      HC

                                                      NOx

                                                      HC+NOx

                                                      PM

                                                      Emissions

                                                      CO
                                                      (g/kWh)

                                                      HC
                                                      (g/kWh)

                                                      NOx

                                                      (g/kWh)

                                                      HC+NOx

                                                      (g/kWh)

                                                      PM
                                                      (g/kWh)

                                                      CO2

                                                      (g/kWh)

                                                      Test result

                                                      Final test result with DF

                                                      Additional control area test points (if applicable)

                                                      Emissions at test point

                                                      Engine speed

                                                      Load
                                                      (%)

                                                      CO
                                                      (g/kWh)

                                                      HC
                                                      (g/kWh)

                                                      NOx

                                                      (g/kWh)

                                                      PM
                                                      (g/kWh)

                                                      Test result 1

                                                      Test result 2

                                                      Test result 3

                                                2.4.1.2.   Sampling system used for the NRSC test: …
                                          2.4.1.2.1.   Gaseous emissions (*): …
                                          2.4.1.2.2.   PM(*): …
                                          2.4.1.2.3.   Method: single/multiple filter (1)
                                          2.4.2.   Information concerning the conduct of the NRTC test (if applicable):
                                          2.4.2.1.   Emission results of the engine/parent engine
                                          Deterioration Factor (DF): calculated/fixed (1)
                                          Specify the DF values and the emission results in the following table:
                                          Regeneration related data may be reported for Stage IV engines.

                                                      NRTC test

                                                      DF mult/add (1)

                                                      CO

                                                      HC

                                                      NOx

                                                      HC+NOx

                                                      PM

                                                      Emissions

                                                      CO
                                                      (g/kWh)

                                                      HC
                                                      (g/kWh)

                                                      NOx

                                                      (g/kWh)

                                                      HC+NOx

                                                      (g/kWh)

                                                      PM
                                                      (g/kWh)

                                                      Cold start

                                                      Emissions

                                                      CO
                                                      (g/kWh)

                                                      HC
                                                      (g/kWh)

                                                      NOx

                                                      (g/kWh)

                                                      HC+NOx

                                                      (g/kWh)

                                                      PM
                                                      (g/kWh)

                                                      CO2

                                                      (g/kWh)

                                                      Hot start w/o regeneration

                                                      Hot start with regeneration

                                                      kr,u (mult/add) (1)
                                                      kr,d (mult/add) (1)

                                                      Weighted test result

                                                      Final test result with DF

                                                Cycle work for hot start w/o regeneration kWh
                                          2.4.2.2.   Sampling system used for the NRTC test:
                                          Gaseous emissions (4): …
                                          PM (4): …
                                          Method: single/multiple filter (5)

                  (2)

                  in Annex II, Appendix 1 is amended as follows:

                              (a)

                              Section 2.2 is replaced by the following:
                              ‘2.2.   Measures taken against air pollution
                              2.2.1.   Device for recycling crankcase gases: yes/no (1) …
                              2.2.2.   Additional anti-pollution devices (if any, and if not covered by another heading)
                              2.2.2.1.   Catalytic converter: yes/no (1)
                              2.2.2.1.1.   Make(s): …
                              2.2.2.1.2.   Type(s): …
                              2.2.2.1.3.   Number of catalytic converters and elements …
                              2.2.2.1.4.   Dimensions- and volume of the catalytic converter(s): …
                              2.2.2.1.5.   Type of catalytic action: …
                              2.2.2.1.6.   Total charge of precious metals: …
                              2.2.2.1.7.   Relative concentration: …
                              2.2.2.1.8.   Substrate (structure and material): …
                              2.2.2.1.9.   Cell density: …
                              2.2.2.1.10.   Type of casing for the catalytic converter(s): …
                              2.2.2.1.11.   Location of the catalytic converter(s) (place(s) and maximum/minimum distance(s) from engine): …
                              2.2.2.1.12.   Normal operating range (K): …
                              2.2.2.1.13.   Consumable reagent (where appropriate): …
                              2.2.2.1.13.1.   Type and concentration of reagent needed for catalytic action: …
                              2.2.2.1.13.2.   Normal operational temperature range of reagent: …
                              2.2.2.1.13.3.   International standard (where appropriate): …
                              2.2.2.1.14.   NOx sensor: yes/no (1)
                              2.2.2.2.   Oxygen sensor: yes/no (1)
                              2.2.2.2.1.   Make(s): …
                              2.2.2.2.2.   Type: …
                              2.2.2.2.3.   Location: …
                              2.2.2.3.   Air injection: yes/no (1)
                              2.2.2.3.1.   Type (pulse air, air pump, etc.): …
                              2.2.2.4.   EGR: yes/no (1)
                              2.2.2.4.1.   Characteristics (cooled/uncooled, high pressure/low pressure, etc.): …
                              2.2.2.5.   Particulate trap: yes/no (1)
                              2.2.2.5.1.   Dimensions and capacity of the particulate trap: …
                              2.2.2.5.2.   Type and design of the particulate trap: …
                              2.2.2.5.3.   Location (place(s) and maximum/minimum distance(s) from engine): …
                              2.2.2.5.4.   Method or system of regeneration, description and/or drawing: …
                              2.2.2.5.5.   Normal operating temperature (K) and pressure (kPa) range: …
                              2.2.2.6.   Other systems: yes/no (1)
                              2.2.2.6.1.   Description and operation: …’;

                              (b)

                              Section 2.4 is replaced by the following:
                              ‘2.4.   Valve timing
                              2.4.1.   Maximum lift and angles of opening and closing in relation to dead centres or equivalent data: …
                              2.4.2.   Reference and/or setting ranges (1): …
                              2.4.3.   Variable valve timing system (if applicable and where intake and/or exhaust)
                              2.4.3.1.   Type: continuous or on/off (6)

                              2.4.3.2.   Cam phase shift angle: …

                  (3)

                  Annex III is replaced by the following:

                     ‘ANNEX III

                        RECOGNITION OF ALTERNATIVE TYPE-APPROVALS

                     The following type-approvals and, where applicable, the pertaining approval marks are recognised as being equivalent to an approval to this Directive:

                                 1.

                                 For engines categories H, I, J and K (stage IIIA) as specified in Article 9(3a) and (3b) of Directive 97/68/EC, type-approvals in accordance with points 3.1, 3.2 and 3.3 of Annex XII to Directive 97/68/EC.

                                 2.

                                 For engines categories L, M, N and P (stage IIIB) as specified in Article 9(3c) of Directive 97/68/EC, type-approvals in accordance with points 4.1, 4.2 and 4.3 of Annex XII to Directive 97/68/EC.

                                 3.

                                 For engines categories Q and R (stage IV) as specified in Article 9(3d) of Directive 97/68/EC, type-approvals in accordance with, points 5.1 and 5.2 of Annex XII to Directive 97/68/EC.’.

         (1)  For full details see Section 2.

         (2)  For full details see Section 4.’;

         (3)  Delete where not applicable.’;

         (4)  Indicate the figure number of the system used as set out in Section 1 of Annex VI to Directive 97/68/EC.

         (5)  Delete where not applicable.’;

         (6)  Delete where not applicable.’;


Avis juridique important

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31978L1020

Council Directive 78/1020/EEC of 5 December 1978 amending Directives 66/401/EEC, 66/402/EEC and 69/208/EEC on the marketing of fodder plant seed, cereal seed of oil and fibre plants

Official Journal L 350 , 14/12/1978 P. 0027 - 0027 Greek special edition: Chapter 03 Volume 23 P. 0090  Spanish special edition: Chapter 03 Volume 15 P. 0066  Portuguese special edition Chapter 03 Volume 15 P. 0066  Finnish special edition: Chapter 3 Volume 10 P. 0130  Swedish special edition: Chapter 3 Volume 10 P. 0130

COUNCIL DIRECTIVE  of 5 December 1978  amending Directives 66/401/EEC, 66/402/EEC and 69/208/EEC on the marketing of fodder plant seed, cereal seed and seed of oil and fibre plants  (78/1020/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 (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas the provisions on the marketing of fodder plant seed, seed of oil and fibre plants provide that, after 1 July 1977, the equivalence of measures taken in third countries concerning official seed examination can no longer be established at national level ; whereas certain equivalence decisions taken at Community level only took effect as from 1 July 1978 ; whereas the period provided for the establishment of equivalence at national level should therefore be extended by one year in order to cover traditional trade patterns which were maintained after 1 July 1977 pending Community decisions;  Whereas the provisions on the marketing of cereal seed allow seeds which have not been the subject of an official field inspection to be certified officially under certain conditions until 31 December 1978 ; whereas an additional period should be granted in order that the necessary experience for a more general and definitive solution may be acquired,  HAS ADOPTED THIS DIRECTIVE:    Article 1 In Article 16 (2) of Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (4), as last amended by Directive 78/692/EEC (5), the date 1 July 1977 shall be replaced by 1 July 1978.   Article 2 In Article 2 (2) (d) of Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (6), as last amended by Directive 78/692/EEC, the date 31 December 1978 shall be replaced by 31 December 1980.   Article 3 In Article 15 (2) of Council Directive 69/208/EEC of 30 June 1969 on the marketing of seed of oil and fibre plants (7), as last amended by Directive 78/388/EEC (8), the date 1 July 1977 shall be replaced by 1 July 1978.   Article 4 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with:    - Articles 1 and 3 with effect on 1 July 1977,       - Article 2, on 31 December 1978 at the latest.          Article 5 This Directive is addressed to the Member States.     Done at Brussels, 5 December 1978.  For the Council  The President  M. LAHNSTEIN  (1)OJ No C 174, 21.7.1978, p. 8. (2)OJ No C 239, 9.10.1978, p. 54. (3)Opinion delivered 12 and 13 July 1978 (not yet published in the Official Journal). (4)OJ No 125, 11.7.1966, p. 2298/66. (5)OJ No L 236, 26.8.1978, p. 13. (6)OJ No 125, 11.7.1966, p. 2309/66. (7)OJ No L 169, 10.7.1969, p. 3. (8)OJ No L 113, 25.4.1978, p. 20.