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31984L0644

Council Directive 84/644/EEC of 11 December 1984 amending Directive 64/432/EEC as regards brucellosis in respect of the buffered brucella antigen test, the micro-agglutination test and the milk ring test as applied to samples of milk

Official Journal L 339 , 27/12/1984 P. 0030 - 0032 Finnish special edition: Chapter 3 Volume 18 P. 0086  Spanish special edition: Chapter 03 Volume 33 P. 0053  Swedish special edition: Chapter 3 Volume 18 P. 0086  Portuguese special edition Chapter 03 Volume 33 P. 0053

+++++( 1 ) OJ NO C 255 , 23 . 9 . 1983 , P . 3 .  ( 2 ) OJ NO C 342 , 19 . 12 . 1983 , P . 117 .  ( 3 ) OJ NO C 23 , 30 . 1 . 1984 , P . 23 .  ( 4 ) OJ NO 121 , 29 . 7 . 1964 , P . 1977/64 .  ( 5 ) SEE PAGE 27 OF THIS OFFICIAL JOURNAL .  COUNCIL DIRECTIVE OF 11 DECEMBER 1984 AMENDING DIRECTIVE 64/432/EEC AS REGARDS BRUCELLOSIS IN RESPECT OF THE BUFFERED BRUCELLA ANTIGEN TEST , THE MICRO-AGGLUTINATION TEST AND THE MILK RING TEST AS APPLIED TO SAMPLES OF MILK ( 84/644/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 COUNCIL DIRECTIVE 64/432/EEC OF 26 JUNE 1964 ON ANIMAL HEALTH PROBLEMS AFFECTING INTRA-COMMUNITY TRADE IN BOVINE ANIMALS ( 4 ) , AS LAST AMENDED BY DIRECTIVE 84/643/EEC ( 5 ) , LAYS DOWN COMMON STANDARDS ON ANTI-BRUCELLOSIS MEASURES APPLICABLE TO ANIMALS INTENDED FOR INTRA-COMMUNITY TRADE ;  WHEREAS IT IS NECESSARY TO INDICATE PRECISELY THAT THE SLOW TUBE SERUM AGGLUTINATION TEST IS THE TEST TO BE CARRIED OUT ON BOVINE ANIMALS AND SWINE BEFORE THEY ENTER INTO INTRA-COMMUNITY TRADE ;  WHEREAS , IN ORDER TO ENSURE THE CONTINUITY OF FREE TRADE WITHIN THE COMMUNITY OF BOVINE ANIMALS , IT IS NECESSARY TO ADAPT THE TECHNICAL PROVISIONS OF THE ABOVE DIRECTIVE RELATING TO BRUCELLOSIS TO TAKE ACCOUNT OF SCIENTIFIC PROGRESS :  WHEREAS NEW SCIENTIFIC KNOWLEDGE AND TECHNICAL DEVELOPMENTS IN THE DIAGNOSIS AND CONTROL OF BOVINE BRUCELLOSIS REQUIRE ADJUSTMENT OF EXISTING COMMUNITY MEASURES IN THIS FIELD ,  HAS ADOPTED THIS DIRECTIVE :  ARTICLE 1  DIRECTIVE 64/432/EEC IS HEREBY AMENDED AS FOLLOWS :  1 . IN ARTICLE 3 ( 3 ) ( C ) , " PARAGRAPH A " IS ADDED AFTER " ANNEX C " .  2 . IN ARTICLE 3 ( 4 ) ( I ) , " PARAGRAPH A " IS ADDED AFTER " ANNEX C " .  3 . IN ARTICLE 3 ( 6 ) ( C ) , " PARAGRAPH A " IS ADDED AFTER " ANNEX C " .  4 . IN ARTICLE 7 ( 1 ) C , " PARAGRAPH A " IS ADDED AFTER " ANNEX C " .  5 . IN ARTICLE 7 ( 1 ) D , " PARAGRAPH A " IS ADDED AFTER " ANNEX C " .  6 . IN ANNEX A.II.A.1 ( C ) ( I ) :  - IN THE FIRST PARAGRAPH , " PARAGRAPH A " IS ADDED AFTER " ANNEX C " ,  - THE SECOND INDENT IS REPLACED BY THE FOLLOWING :  " - THE SERO-AGGLUTINATION TESTS REFERRED TO IN THE FIRST PARAGRAPH MAY BE REPLACED BY TWO OFFICIAL BUFFERED BRUCELLA ANTIGEN TESTS OR TWO MICRO-AGGLUTINATION TESTS CARRIED OUT IN ACCORDANCE WITH ANNEX C ( D ) AND ( G ) . THESE TESTS SHALL ALSO BE CARRIED OUT AT INTERVALS OF AT LEAST THREE MONTHS AND AT MOST 12 MONTHS . "  7 . ANNEX A.II.A.1 ( C ) ( II ) IS REPLACED BY THE FOLLOWING :  " ( II ) ARE CHECKED ANNUALLY TO ESTABLISH THAT BRUCELLOSIS IS NOT PRESENT BY THREE RING TESTS CARRIED OUT AT INTERVALS OF AT LEAST THREE MONTHS OR TWO RING TESTS AT AN INTERVAL OF AT LEAST THREE MONTHS AND ONE SEROLOGICAL TEST ( SERO-AGGLUTINATION TEST OR BUFFERED BRUCELLA ANTIGEN TEST OR PLASMA AGGLUTINATION TEST OR PLASMA RING TEST OR MICRO-AGGLUTINATION TEST ) CARRIED OUT AT NOT LESS THAN SIX WEEKS AFTER THE SECOND RING TEST . IF RING TESTS ARE NOT CARRIED OUT , TWO SEROLOGICAL TESTS ( SERO-AGGLUTINATION TEST OR BUFFERED BRUCELLA ANTIGEN TEST OR PLASMA AGGLUTINATION TEST OR PLASMA RING TEST OR MICRO-AGGLUTINATION TEST ) SHALL BE CARRIED OUT EACH YEAR AT INTERVALS OF AT LEAST THREE MONTHS AND NOT MORE THAN SIX MONTHS .  WHERE , IN A MEMBER STATE OR REGION THEREOF IN WHICH ALL BOVINE HERDS ARE SUBJECT TO OFFICIAL OPERATIONS TO COMBAT BRUCELLOSIS , NOT MORE THAN 1 % OF BOVINE HERDS ARE INFECTED , IT SHALL BE SUFFICIENT TO CARRY OUT EACH YEAR TWO RING TESTS AT AN INTERVAL OF AT LEAST THREE MONTHS , OR ONE SEROLOGICAL TEST ( SERO-AGGLUTINATION TEST OR BUFFERED BRUCELLA ANTIGEN TEST OR PLASMA-AGGLUTINATION TEST OR PLASMA-RING TEST OR MICRO-AGGLUTINATION TESTS ) .  WHERE CHECKS ARE CARRIED OUT ON BULK TANKS , THE NUMBER OF TESTS REFERRED TO IN THE PRECEDING SUBPARAGRAPHS SHALL BE DOUBLED AND THE INTERVALS BETWEEN THE TESTS SHALL BE HALVED . "  8 . IN ANNEX A.II.A.2 ( C ) , THE LAST PARAGRAPH IS REPLACED BY THE FOLLOWING :  " THE SERO-AGGLUTINATION TESTS REFERRED TO IN 1 ( C ) ( I ) , FIRST INDENT , MAY BE REPLACED BY BUFFERED BRUCELLA ANTIGEN TESTS CARRIED OUT IN ACCORDANCE WITH ANNEX C ( D ) OR MICRO-AGGLUTINATION TESTS CARRIED OUT IN ACCORDANCE WITH ANNEX C ( G ) . "  9 . IN ANNEX C :  - PARAGRAPH C IS REPLACED BY THE FOLLOWING :  " C . RING TEST  1 . THE RING TEST MUST BE MADE ON THE CONTENTS OF EACH MILK CHURN OR ON THE CONTENTS OF EACH BULK TANK FROM THE FARM .  2 . THE STANDARD ANTIGEN TO BE USED MUST COME FROM ONE OF THE INSTITUTES LISTED IN PARAGRAPH A.9 ( A ) TO ( J ) . IT IS RECOMMENDED THAT THE ANTIGENS SHOULD BE STANDARDIZED ACCORDING TO THE WHO/FAO RECOMMENDATIONS .  3 . THE ANTIGEN MAY BE STAINED ONLY WITH HEMATOXYLIN OR TETRAZOLIUM ; HEMATOXYLIN SHOULD PREFERABLY BE USED .  4 . IF NO PRESERVATION IS USED THEN THE REACTION TEST MUST BE CARRIED OUT BETWEEN 18 AND 24 HOURS OF TAKING THE SAMPLE FROM THE COW . IF MILK IS TO BE TESTED LATER THAN 24 HOURS AFTER SAMPLING , THEN PRESERVATION MUST BE USED , FORMALIN OR MERCURIC CHLORIDE MAY BE USED AS PRESERVATIVES AND IF EITHER OF THESE ARE USED THE TEST MUST BE CARRIED OUT WITHIN THE FOLLOWING 14 DAYS AFTER THE DAY OF SAMPLING . FORMALIN MAY BE ADDED TO GIVE A FINAL CONCENTRATION IN THE MILK SAMPLE OF 0,2 % AND , IN SUCH CASES , THE RATIO BETWEEN THE AMOUNT OF MILK AND THE SOLUTION OF FORMALIN MUST BE AT LEAST 10 TO 1 . A SOLUTION OF MERCURIC CHLORIDE MAY BE USED INSTEAD OF FORMALIN TO GIVE A FINAL CONCENTRATION IN THE MILK OF 0,2 % AND , IN SUCH CASES , THE RATIO BETWEEN THE AMOUNT OF MILK AND THE SOLUTION OF MERCURIC CHLORIDE MUST BE 10 TO 1 .  5 . THE REACTION MUST BE CARRIED OUT USING ONE OF THE FOLLOWING METHODS :  - ON A COLUMN OF MILK AT LEAST 25 MM HIGH AND ON A VOLUME OF MILK OF 1 ML TO WHICH 0,03 ML OF ONE OF THE STANDARDIZED STAINED ANTIGENS HAS BEEN ADDED ,  - ON A COLUMN OF MILK AT LEAST 25 MM HIGH AND ON A VOLUME OF MILK OF 1 ML TO WHICH 0,05 ML OF ONE OF THE STANDARDIZED STAINED ANTIGENS HAS BEEN ADDED ,  - ON A VOLUME OF MILK OF 8 ML WHICH 0,08 ML OF ONE OF THE STANDARDIZED STAINED ANTIGENS HAS BEEN ADDED ,  - ON A COLUMN OF MILK AT LEAST 25 MM HIGH AND ON A VOLUME OF MILK OF 2 ML TO WHICH 0,05 ML OF ONE OF THE STANDARDIZED STAINED ANTIGENS HAS BEEN ADDED .  6 . THE MIXTURE OF MILK AND ANTIGENS MUST BE INCUBATED AT 37* C FOR NOT LESS THAN 45 MINUTES AND NOT MORE THAN 60 MINUTES . THE TEST MUST BE ASSESSED WITHIN 15 MINUTES OF REMOVAL FROM THE INCUBATOR .  7 . THE REACTION MUST BE ASSESSED ACCORDING TO THE FOLLOWING CRITERIA :  ( A ) NEGATIVE REACTION : COLOURED MILK , COLOURLESS CREAM ;  ( B ) POSITIVE REACTION : MILK AND CREAM IDENTICALLY COLOURED OR COLOURLESS MILK AND COLOURED CREAM . " ;  - A NEW PARAGRAPH G SHALL BE ADDED :  " G . MICRO-AGGLUTINATION TEST  1 . DILUENTS ARE MADE UP OF 0,85 % PHYSIOLOGICAL SALINE SOLUTION PHENOLIZED AT 0,5 % .  2 . THE ANTIGEN SHALL BE PREPARED AS DESCRIBED UNDER POINTS 6 , 7 AND 8 OF ANNEX C ( A ) AND SHALL BE TITRATED AS DESCRIBED UNDER POINT 5 OF ANNEX C ( A ) . AT THE MOMENT THE ANTIGEN IS USED SAFRANIN O SHALL BE ADDED AT 0,02 % ( FINAL DILUTION ) .  3 . THE STANDARD SERUM IS THE SAME AS THAT UNDER POINT 1 OF ANNEX C ( A ) .  4 . THE STANDARD SERUM MUST BE SUPPLIED BY THE BUNDESGESUNDHEITSAMT , BERLIN .  5 . THE MICRO-AGGLUTINATION TEST SHALL BE CARRIED OUT ON PLATES BEARING WELLS WITH CONICAL BOTTOMS OF A VOLUME OF 0,250 ML . THE TEST SHALL BE CARRIED OUT AS FOLLOWS :  ( A ) PREDILUTION OF THE SERUM : 0,050 ML OF EACH SERUM TO BE TESTED ARE ADDED TO EACH WELL CONTAINING 0,075 ML OF DILUENT . THE MIXTURES ARE SHAKEN FOR 30 SECONDS .  ( B ) GRADUAL SERUM DILUTION : PREPARE AT LEAST THREE DILUTIONS FOR EACH SERUM . TO THIS END FROM THE PREDILUTIONS ( 1 : 2,5 ) ONE TAKES 0,025 ML OF EACH SERUM AND TRANSFERS THEM TO A WELL CONTAINING 0,025 ML OF DILUENT . IN THIS WAY THE FIRST DILUTION REACHES A STRENGTH OF 1 : 5 AND THE FOLLOWING DILUTIONS ARE CARRIED OUT BY DOUBLING .  ( C ) ADDITION OF ANTIGEN : 0,025 ML OF ANTIGEN IS ADDED TO EACH WELL CONTAINING THE DIFFERENT SERUM DILUTIONS . AFTER BEING SHAKEN FOR 30 SECONDS THE PLATES ARE CLOSED WITH THEIR RESPECTIVE LIDS AND KEPT AT 37* C FOR 20 TO 24 HOURS IN A HUMIDIFIED ATMOSPHERE .  ( D ) READING THE RESULTS : ASSESSMENT OF THE ASPECT OF THE SEDIMENTATION OF THE ANTIGEN IS MADE BY EXAMINING THE BOTTOM OF THE WELL REFLECTED IN A CONCAVE MIRROR PLACED ABOVE IT . IF THERE IS A NEGATIVE REACTION , THE ANTIGEN FORMS A SEDIMENT IN THE FORM OF A COMPACT BUTTON WITH CLEAR EDGES AND HAVING AN INTENSE RED COLOUR . IF THERE IS A POSITIVE REACTION , ON THE OTHER HAND , A DIFFUSED PINK VEIL IS FORMED THAT IS EVENLY DISTRIBUTED . THE DIFFERENT PERCENTAGES OF AGGLUTINATION ARE DETERMINED BY COMPARISON WITH ANTIGEN CHECKS INDICATING 0 , 25 , 50 , 75 AND 100 % AGGLUTINATION . THE TITLE OF EACH SERUM IS EXPRESSED IN INTERNATIONAL UNITS OF AGGLUTINATION PER ML . THERE SHOULD BE INCLUDED IN THE TEST , CONTROLS WITH NEGATIVE AND POSITIVE SERUM DILUTED SO AS TO CONTAIN 30 INTERNATIONAL UNITS OF AGGLUTINATION PER ML . "  ARTICLE 2  MEMBER STATES SHALL BRING INTO FORCE THE LAWS , REGULATIONS AND ADMINISTRATIVE PROVISIONS NECESSARY TO COMPLY WITH THIS DIRECTIVE BY 30 SEPTEMBER 1985 . THEY SHALL FORTHWITH INFORM THE COMMISSION THEREOF .  ARTICLE 3  THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .  DONE AT BRUSSELS , 11 DECEMBER 1984 .  FOR THE COUNCIL  THE PRESIDENT  A . DEASY


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31999L0082

Commission Directive 1999/82/EC of 8 September 1999 amending the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (Text with EEA relevance)

Official Journal L 243 , 15/09/1999 P. 0007 - 0008

COMMISSION DIRECTIVE 1999/82/ECof 8 September 1999amending the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products(1), as last amended by Directive 93/39/EEC(2), and in particular Article 2(a)(1) thereof,(1) Whereas Commission Decision 97/534/EC of 30 July 1997 on the prohibition of the use of material presenting risks as regards transmissible spongiform encephalopathies(3) defines specified risk materials, provides for their elimination at source and prohibits their import into the Community;(2) Whereas, prior to being marketed, all medicinal products, whether they originate in the Community or are imported from third countries, are subject to an approval procedure in the context of which the treatment process of any raw material is evaluated, in conformity with the provisions of the Annex to Directive 75/318/EEC;(3) Whereas this approval procedure applies to all medicinal products to be placed on the market in the Community, notwithstanding the origin of the product or the raw materials contained therein; whereas, thereby, the compliance with Community law of medicinal products, starting materials and intermediate products which are imported into the Community to be used in the manufacture of medicinal products is systematically controlled and checked;(4) Whereas on 21 April 1999, the Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products adopted an updated Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products;(5) Whereas, in drafting this updated Note for Guidance, the Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products took into account all relevant Opinions of the Scientific Committee on Medicinal Products and Medical Devices, as well as the Scientific Steering Committee and additional scientific considerations which apply to the specific field of medicinal products;(6) Whereas, the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products will have to be regularly updated and modified by the Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products, taking into account the latest scientific developments;(7) Whereas the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products and its updates are published by the European Commission in Volume 3 of its publication "The rules governing medicinal products in the European Union";(8) Whereas this Note for Guidance is considered to be adequate to assure that the risk of transmitting Animal Spongiform Encephalopathy via medicinal products is minimised since manufacturers of medicinal products are obliged under Directive 75/318/EEC to take into account the relevant Community guidelines in assembling the dossier for application for marketing authorisation;(9) Whereas it contributes to the clarity of the legal situation and ensures the highest reasonable level of protection of public health to amend the Annex to Directive 75/318/EEC to expressly make compliance with the above Note for Guidance binding with regard to all marketing authorisations for medicinal products and to provide for an appropriate phasing-in period for already existing marketing authorisations;(10) Whereas the measures provided for in this Directive are in conformity with the opinion of the Standing Committee for Medicinal Products for Human Use,HAS ADOPTED THIS DIRECTIVE:Article 1The Annex to Directive 75/318/EEC is hereby amended as shown in the Annex.Article 21. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 1 January 2000.2. Member States shall take the necessary measures to ensure that:- applications for marketing authorisations for medicinal products lodged as from 1 July 2000 comply with the criteria set out in the Annex to this Directive,- all marketing authorisations for medicinal products meet the criteria of the Annex to this Directive not later than 1 March 2001.3. When the Member States adopt the provisions set out in paragraph 1, 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 references shall be adopted by the Member States.4. The Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.Article 3This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.Article 4This Directive is addressed to the Member States.Done at Brussels, 8 September 1999.For the CommissionKarel VAN MIERTMember of the Commission(1) OJ L 147, 9.6.1975, p. 1.(2) OJ L 214, 24.8.1993, p. 22.(3) OJ L 216, 8.8.1997, p. 95.ANNEXA new paragraph C.a is inserted in Part 2 of the Annex to Directive 75/318/EEC : "C.a Specific measures concerning the prevention of the transmission of animal spongiform encephalopathiesThe applicant must demonstrate that the medicinal product is manufactured in accordance with the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products and its updates, published by the European Commission in Volume 3 of its publication "The rules governing medicinal products in the European Union"."


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31993L0076

Council Directive 93/76/EEC of 13 September 1993 to limit carbon dioxide emissions by improving energy efficiency (SAVE)

Official Journal L 237 , 22/09/1993 P. 0028 - 0030 Finnish special edition: Chapter 12 Volume 2 P. 0168  Swedish special edition: Chapter 12 Volume 2 P. 0168

COUNCIL DIRECTIVE 93/76/EEC of 13 September 1993 to limit carbon dioxide emissions by improving energy efficiency (SAVE)THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 130s and 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, by its resolution of 16 September 1986 (4), the Council set new Community energy policy objectives for 1995 and convergence of the policies of the Member States;  Whereas the Council of Environment and Energy Ministers agreed at their meeting on 29 October 1990 that the Community and the Member States, assuming that other leading countries undertook similar commitments, and acknowledging the targets identified by  a number of Member States for stabilizing or reducing emissions by different dates, were willing to take actions aimed at reaching stabilization of the total carbon dioxide emissions by the year 2000 at the 1990 level in the Community as a whole;  whereas it was also agreed that Member States which start from relatively low levels of energy consumption and therefore low emissions measured on a per capita or other appropriate basis are entitled to have carbon dioxide targets and/or strategies  corresponding to their economic and social development, while improving the energy efficiency of their economic activities;  Whereas by Decision 91/565/EEC the Council adopted the SAVE programme aimed at promoting energy efficiency in the Community (5);  Whereas Article 130r of the Treaty stipulates that the objective of action by the Community relating to the environment shall be to ensure a prudent and rational utilization of natural resources; whereas these natural resources include oil products,  natural gas and solid fuels, which are essential sources of energy but also the leading sources of carbon dioxide emissions;  Whereas, since the Treaty has not provided elsewhere the powers required to legislate on energy-related aspects of the programmes laid down in this Directive, recourse should be had also to Article 235 of the Treaty;  Whereas the residential and tertiary sectors account for nearly 40 % of final energy consumption in the Community and are expanding, a trend which is bound to increase their energy consumption and hence also their carbon dioxide emissions;  Whereas this Directive aims to preserve the quality of the environment and to ensure a prudent and rational utilization of natural resources, which are matters of non-exclusive Community competence;  Whereas a collective effort by all Member States, implying measures at Community level, is necessary in order to limit carbon dioxide emissions and to promote the rational use of energy;  Whereas the measures are to be determined according to the principle of subsidiarity by Member States on the basis of potential improvements in energy efficiency, cost effectiveness, technical feasibility and environmental impact;  Whereas, by providing objective information on the energy characteristics of buildings, energy certification will help to improve transparency of the property market and to encourage investment in energy savings;  Whereas the billing, to occupiers of buildings, of heating, air-conditioning and hot water costs calculated, in an appropriate proportion, on the basis of actual consumption will contribute towards energy saving in the residential sector; whereas it is  desirable that occupants of such buildings should be enabled to regulate their own consumption of heat, cold and hot water; whereas the recommendations and resolutions adopted by the Council on the billing of heating and hot water costs (6) have been  applied in only two Member States; whereas a significant proportion of heating, air-conditioning and hot water costs are still being billed on the basis of factors other than energy consumption;  Whereas new methods of financial support are needed to promote investments in energy saving in the public sector; whereas, with that in mind, the Member States should permit and make full use of the possibilities offered by third-party financing;  Whereas buildings will have an impact on long-term energy consumption; whereas new buildings should therefore be fitted with efficient thermal insulation tailored to the local climate; whereas this applies also to public authority buildings where the  public authorities should set an example in taking environmental and energy considerations into account;  Whereas regular maintenance of boilers contributes to maintaining their correct adjustment in accordance with the product specification and in that way to an optimal performance from an environmental and energy point of view;  Whereas industry is generally willing to make more efficient use of energy to meet its own economic objectives; whereas energy audits in particular in undertakings with high energy consumption should be promoted to bring about significant improvements  in energy efficiency in this sector;  Whereas improving energy efficiency in all regions of the Community will strengthen economic and social cohesion in the Community, as provided for in Article 130a of the Treaty,  HAS ADOPTED THIS DIRECTIVE:   Article 1  The purpose of this Directive is the attainment by Member States of the objective of limiting carbon dioxide emissions by improving energy efficiency, notably by means of drawing up and implementing programmes in the following fields:  - energy certification of buildings,  - the billing of heating, air-conditioning and hot water costs on the basis of actual consumption,  - third-party financing for energy efficiency investments in the public sector,  - thermal insulation of new buildings,  - regular inspection of boilers,  - energy audits of undertakings with high energy consumption.  Programmes can include laws, regulations, economic and administrative instruments, information, education and voluntary agreements whose impact can be objectively assessed.   Article 2  Member States shall draw up and implement programmes on the energy certification of buildings. Energy certification of buildings, which shall consist of a description of their energy characteristics, must provide information for prospective  users concerning a building's energy efficiency.  Whereas appropriate, certification may also include options for the improvement of these energy characteristics.   Article 3  Member States shall draw up and implement programmes on the billing of heating, air-conditioning and hot water costs calculated, in an appropriate proportion, on the basis of actual consumption. These programmes shall enable the cost of these  services to be apportioned among the users of all or part of a building on the basis of the specific quantities of heat, of cold and of hot water consumed by each occupier. This shall apply to buildings or parts of buildings supplied by a collective  heating, air-conditioning or domestic hot water installation. Occupants of such buildings should be enabled to regulate their own consumption of heat, cold or hot water.   Article 4  Member States shall draw up and implement programmes to permit third-party financing for energy efficiency investments in the public sector.  For the purposes of this Directive, 'third-party financing' means the overall provision of auditing, installation, operation, maintenance and financing services for an energy efficiency investment, with recovery of the cost of these services being  contingent, either wholly or in part, on the level of energy savings.   Article 5  Member States shall draw up and implement programmes so that new buildings receive effective thermal insulation, taking a long-term view, on the basis of standards laid down by the Member States, taking account of climatic conditions or  climatic areas and the intended use of the building.   Article 6  Member States shall draw up and implement programmes on the regular inspection of heating installations of an effective rated output of more than 15 Kw with the aim of improving operating conditions from the point of view of energy  consumption and of limiting carbon dioxide emissions.   Article 7  Member States shall draw up and implement programmes with the aim of promoting the regular completion of energy audits of industrial undertakings with high energy consumption to improve their energy efficiency and limit emissions of carbon  dioxide, and may make similar provisions for other undertakings with high energy consumption.   Article 8  Member States shall determine the scope of the programmes referred to in Articles 1 to 7 on the basis of potential improvements in energy efficiency, cost-effectiveness, technical feasibility and environmental impact.   Article 9  Member States shall report to the Commission every two years on the results of the measures taken to implement the programmes provided for in this Directive. In so doing, they shall inform the Commission of the choices they have made in their  package of measures. In addition, they shall, on request, provide the Commission with justification for the content of the programmes, taking Article 8 into account.  In considering Member States' reports, the Commission shall be assisted by the advisory committee referred to in Decision 91/565/EEC following the procedure referred to in Article 6 of that Decision.   Article 10  1. Member States shall bring into force the laws, regulations and/or other measures as mentioned in Article 1 as necessary to comply with this Directive as soon as possible and not later than 31 December 1994. Member States are required to  make all the necessary provisions to enable them to fulfil the objectives of this Directive.  When Member States adopt laws or regulations for this purpose, such laws or regulations shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a  reference shall be laid down by the Member States. This shall apply by analogy where the programmes are transposed in another form.  2. Member States shall communicate to the Commission the provisions of national law and/or other measures as mentioned in Article 1 which they adopt in the field covered by this Directive.   Article 11  This Directive is addressed to the Member States.  Done at Brussels, 13 September 1993.  For the Council The President Ph. MAYSTADT  (1) OJ No C 179, 16. 7. 1992, p. 8.  (2) OJ No C 176, 28. 6. 1993.  (3) OJ No C 19, 25. 1. 1993, p. 134.  (4) OJ No C 241, 25. 9. 1986, p. 1.  (5) OJ No L 307, 8. 11. 1991, p. 34.  (6) Recommendation 76/493/EEC (OJ No L 140, 28. 5. 1976, p. 12). Recommendation 77/712/EEC (OJ No L 295, 18. 11. 1977, p. 1). Resolution of 9. 6. 1980 (OJ No C 149, 18. 6. 1980, p. 3). Resolution of 15. 1. 1985 (OJ No C 20, 22. 1. 1985, p. 1).


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31985L0038

Commission Directive 85/38/EEC of 14 December 1984 amending Annexes I and II to Council Directive 66/401/EEC on the marketing of fodder plant seed

Official Journal L 016 , 19/01/1985 P. 0041 - 0042 Spanish special edition: Chapter 03 Volume 33 P. 0113  Portuguese special edition Chapter 03 Volume 33 P. 0113  Finnish special edition: Chapter 3 Volume 18 P. 0101  Swedish special edition: Chapter 3 Volume 18 P. 0101

*****COMMISSION  DIRECTIVE  of 14 December 1984  amending Annexes I and II to Council Directive 66/401/EEC on the marketing of fodder plant seed  (85/38/EEC)  THE COMMISSION OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (1), as last amended by Directive 82/287/EEC (2), and in particular Article 21a thereof,  Whereas, in the light of the development of scientific and technical knowledge, Annexes I and II to Directive 66/401/EEC should be amended for the reasons set out hereafter;  Whereas it is well known, in the case of a certain type of varieties of smooth-stalked meadowgrass (Poapratensis L.), that the varietal purity can more easily be examined than in other varieties; whereas, therefore, specific tolerance levels for varietal purity have already been set up for this type in Annex II of the beforementioned Directive;  Whereas the varietal purity standards applicable to smooth-stalked meadowgrass as well as the procedure to examine satisfaction of them should be adjusted in such a way as to eliminate possible discrimination between the different types of varieties, to give references for field inspection in all cases and to take into account current certification practices;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Annex I to Directive 66/401/EEC is hereby amended as follows:  1. In the table in paragraph 2, 'apomictic uniclonal varieties of Poa spp' is replaced by 'varieties of Poa pratensis referred to in the second part of the third sentence of paragraph 4'.  2. In the second sentence of paragraph 4, 'or of apomictic uni-clonal varieties of Poa spp' is replaced by 'or of Poa pratensis'.  3. In paragraph 4, the following is inserted after the second sentence:  'In the case of Poa pratensis, the number of plants of the crop species which are recognizable as obviously not being true to the variety shall not exceed:  - one per 20 m2 for the production of basic seed,  - four per 10 m2 for the production of certified seed;  however, in the case of varieties which are officially classified as "apomictic uni-clonal varieties" under agreed procedures, a number of plants recognizable as not being true to the variety, which does not exceed six per 10 m2, may be regarded as satisfying the beforementioned standards for the production of certified seed. Upon application, a Member State may be authorized, in accordance with the procedure laid down in Article 21, to assess the satisfaction of the varietal purity standards in the case of crops of Poa pratensis belonging to such varieties not only on the basis of the results of the field inspection carried out in accordance with paragraph 6 of Annex I, where there is evidence that compliance with the varietal purity standards set up in Annex II is ensured by appropriate seed testing or other appropriate means.'  4. In the last sentence of paragraph 4, 'and of apomictic uni-clonal varieties of Poa spp' is deleted.  Article 2  Annex II to Directive 66/401/EEC is hereby amended as follows:  1. In the first indent of the second sentence of paragraph 1 of section I, 'Poa spp, apomictic uni-clonal varieties' is replaced by 'Poa pratensis, varieties referred to in the second part of the third sentence of paragraph 4 of Annex I'.  2. In the first sentence of paragraph 1 of section II, 'and of apomictic uni-clonal varieties of Poa spp' is  replaced by 'and of varieties of Poa pratensis referred to in the second part of the third sentence of paragraph 4 of Annex I'.  Article 3  Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 1 January 1986. They shall forthwith inform the Commission and the other Member States thereof.  Article 4  This Directive is addressed to the Member States.  Done at Brussels, 14 December 1984.  For the Commission  Poul DALSAGER  Member of the Commission  (1) OJ No 125, 11. 7. 1966, p. 2298/66.  (2) OJ No L 131, 13. 5. 1982, p. 24.


title: Commission Directive 2008/69/EC of 1 July 2008 amending Council Directive 91/414/EEC to include clofentezine, dicamba, difenoconazole, diflubenzuron, imazaquin, lenacil, oxadiazon, picloram and pyriproxyfen as active substances (Text with EEA relevance)

text:
               2.7.2008

               EN

               Official Journal of the European Union

               L 172/9

      COMMISSION DIRECTIVE 2008/69/EC
   of 1 July 2008
   amending Council Directive 91/414/EEC to include clofentezine, dicamba, difenoconazole, diflubenzuron, imazaquin, lenacil, oxadiazon, picloram and pyriproxyfen as active substances
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes the active substances listed in the Annex to this Directive.

               (2)

               By Regulation (EC) No 1095/2007 a new Article 11b was inserted into Regulation (EC) No 1490/2002 to allow active substances for which there are clear indications that it may be expected that they do not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, to be included in Annex I to Directive 91/414/EEC without detailed scientific advice from the European Food Safety Authority (EFSA) having been sought.

               (3)

               For the active substances listed in the Annex to this Directive the Commission examined in accordance with Article 11a of Regulation (EC) No 1490/2002 the effects on human, animal health, groundwater and the environment for a range of uses proposed by the notifiers, with the conclusion that those active substances satisfy the requirements of Article 11b of Regulation (EC) No 1490/2002.

               (4)

               In accordance with Article 12(1) of Regulation (EC) No 1490/2002 the Commission has submitted draft review reports for the active substances listed in the Annex to this Directive to the Standing Committee on the Food Chain and Animal Health, for examination. Those reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 14 March 2008 in the format of the Commission review reports. In accordance with Article 12a of Regulation (EC) No 1490/2002 the Commission is to request the EFSA to deliver its view on the draft review reports by 31 December 2010 at the latest.

               (5)

               It has appeared from the various examinations made that plant protection products containing the active substances listed in the Annex to this Directive may be expected to satisfy, in general, the requirements laid down in Article 5(1) (a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include in Annex I to that Directive the active substances listed in the Annex to this Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.

               (6)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

               (7)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing the active substances listed in the Annex to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (8)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (4) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives that have been adopted until now amending Annex I.

               (9)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (10)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 30 June 2009 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 July 2009.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing the active substances listed in the Annex as active substances by 30 June 2009.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to the active substances listed in the Annex are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holders of the authorisations have, or have access to, dossiers satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing one of the active substances listed in the Annex as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 December 2008 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning the active substances listed in the Annex. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing one of the active substances listed in the Annex as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2013 at the latest; or

               (b)

               in the case of a product containing one of the active substances listed in the Annex as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2013 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 4
   This Directive shall enter into force on 1 January 2009.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 1 July 2008.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2008/45/EC (OJ L 94, 5.4.2008, p. 21).

      (2)  OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regulation (EC) No 1044/2003 (OJ L 151, 19.6.2003, p. 32).

      (3)  OJ L 224, 21.8.2002, p. 23. Regulation as last amended by Regulation (EC) No 1095/2007 (OJ L 246, 21.9.2007, p. 19).

      (4)  OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regulation (EC) No 416/2008 (OJ L 125, 9.5.2008, p. 25).

      ANNEX
      The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:

                     No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘177

                     Clofentezine
                     CAS No 74115-24-5
                     CIPAC No 418

                        3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine

                     ≥ 980 g/kg (dry material)

                     1 January 2009

                     31 December 2018

                     PART A
                     Only uses as acaricide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on clofentezine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

                     178

                     Dicamba
                     CAS No 1918-00-9
                     CIPAC No 85

                        3,6-dichloro-2-methoxybenzoic acid

                     ≥ 850 g/kg

                     1 January 2009

                     31 December 2018

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on dicamba, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

                     179

                     Difenoconazole
                     CAS No 119446-68-3
                     CIPAC No 687

                        3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether

                     ≥ 940 g/kg

                     1 January 2009

                     31 December 2018

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on difenoconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the protection of aquatic organisms.

                           Conditions of use shall include adequate risk mitigation measures, where appropriate.

                     180

                     Diflubenzuron
                     CAS No 35367-38-5
                     CIPAC No 339

                        1-(4-chlorophenyl)-3-(2,6-difluorobenzoyl) urea

                     ≥ 950 g/kg impurity: max. 0,03 g/kg 4-chloroaniline

                     1 January 2009

                     31 December 2018

                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on diflubenzuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the protection of aquatic organisms,

                                 —

                                 the protection of terrestrial organisms,

                                 —

                                 the protection of non-target arthropods including bees.

                           Conditions of use shall include adequate risk mitigation measures, where appropriate.

                     181

                     Imazaquin
                     CAS No 81335-37-7
                     CIPAC No 699

                        2-[(RS)-4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl]quinoline-3-carboxylic acid

                     ≥ 960 g/kg (racemic mixture)

                     1 January 2009

                     31 December 2018

                     PART A
                     Only uses as plant growth regulator may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on imazaquin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

                     182

                     Lenacil
                     CAS No 2164-08-1
                     CIPAC No 163

                        3-cyclohexyl-1,5,6,7-tetrahydrocyclopentapyrimidine-2,4(3H)-dione

                     ≥ 975 g/kg

                     1 January 2009

                     31 December 2018

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on lenacil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

                     183

                     Oxadiazon
                     CAS No 19666-30-9
                     CIPAC No 213

                        5-tert-butyl-3-(2,4-dichloro-5-isopropoxyphenyl)-1,3,4-oxadiazol-2(3H)-one

                     ≥ 940 g/kg

                     1 January 2009

                     31 December 2018

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on oxadiazon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

                     184

                     Picloram
                     CAS No 1918-02-1
                     CIPAC No 174

                        4-amino-3,5,6-trichloropyridine-2-carboxylic acid

                     ≥ 920 g/kg

                     1 January 2009

                     31 December 2018

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on picloram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

                     185

                     Pyriproxyfen
                     CAS No 95737-68-1
                     CIPAC No 715

                        4-phenoxyphenyl (RS)-2-(2-pyridyloxy)propyl ether

                     ≥ 970 g/kg

                     1 January 2009

                     31 December 2018

                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pyriproxyfen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the protection of non-target arthropods including bees.

                           Conditions of use shall include adequate risk mitigation measures, where appropriate.

         (1)  Further details on the identity and specification of the active substance are provided in the review report.’


Avis juridique important

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32000L0008

Directive 2000/8/EC of the European Parliament and of the Council of 20 March 2000 amending Council Directive 70/221/EEC on the approximation of the laws of the Member States relating to liquid fuel tanks and rear underrun protection of motor vehicles and their trailers

Official Journal L 106 , 03/05/2000 P. 0007 - 0020

Directive 2000/8/EC of the European Parliament and of the Councilof 20 March 2000amending Council Directive 70/221/EEC on the approximation of the laws of the Member States relating to liquid fuel tanks and rear underrun protection of motor vehicles and their trailersTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),Whereas:(1) Council Directive 70/221/EEC of 20 March 1970 on the approximation of the laws of the Member States relating to liquid fuel tanks and rear underrun protection for motor vehicles and their trailers(4), is one of the separate directives within the EC type-approval procedure which was established by Council Directive 70/156/EEC of 6 February 1990 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers(5); consequently, the provisions and definitions laid down in Directive 70/156/EEC concerning vehicles, vehicles systems, components and separate technical units apply to Directive 70/221/EEC; it is necessary to adapt Article 1 of Directive 70/221/EEC to the definitions of Directive 70/156/EEC.(2) In order to take account of technical progress, it is advisable to adapt Directive 70/221/EEC to the technical requirements adopted by the United Nations Economic Commission for Europe in its Regulation No 34 relating to the approval of vehicles with regard to the prevention of fire risk, in particular, to the provisions of fuel tanks made of plastic material.(3) The accidental spillage of fuel (especially diesel) on to the road is a significant hazard for riders of two-wheeled motor vehicles and pedal cycles.(4) There is increasing interest in gaseous fuels for the propulsion of motor vehicles, in particular for environmental reasons; whereas therefore, in future, Directive 70/221/EEC should also contain provisions for tanks for fuels other than liquid fuels; for this purpose the title and the scope of Directive 70/221/EEC should be amended accordingly; technical specifications for tanks for gaseous fuels will be introduced through later amendments of the said Directive.(5) Furthermore, it is more and more common for original fuel tanks to be replaced by larger fuel tanks or for additional, unapproved fuel tanks to be installed; provision should consequently be made at the earliest opportunity for Community type-approval of liquid and gas fuel tanks as separate technical units, in order to maintain a high level of safety in motor-vehicle traffic.(6) Amendments to the provisions relating to fuel tanks have to be adopted by the European Parliament and the Council; whereas it is expedient that, in the future, amendments necessary for adjusting the technical requirements of Directive 70/221/EEC relating to fuel tanks to technical progress should be adopted in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC.(7) The amendments made by this Directive relate in particular to fuel tanks made of a plastic material; it is unnecessary therefore to invalidate existing approvals granted under Directive 74/60/EEC(6) and to prevent the sale, registration and entry into service of new vehicles having metal liquid fuel tanks covered by such approvals.(8) Given the scale and impact of the action proposed in the sector in question, the Community measures which are the subject of this Directive are necessary, or even indispensable, to attain the objective set, namely Community vehicle type-approval; this objective cannot be adequately achieved by the Member States individually,HAVE ADOPTED THIS DIRECTIVE:Article 1Directive 70/221/EEC is hereby amended as follows:1. The title shall be replaced by the following:"Council Directive of 20 March 1970 on the approximation of the laws of the Member States relating to fuel tanks and rear underrun protection of motor vehicles and their trailers".2. Article 1 shall be replaced by the following:"Article 1For the purpose of this Directive, 'vehicle' means any motor vehicle and its trailers as defined in Annex II Section A to Directive 70/156/EEC."3. Article 2(1) shall be replaced by the following:"1. No Member State may refuse to grant EC type-approval or national type-approval for a vehicle on grounds relating to its fuel tanks if such vehicle satisfies the requirements set out in this Directive concerning fuel tanks."4. Article 2a(1) shall be replaced by the following:"1. No Member State may refuse or prohibit the sale, registration, entry into service or use of a vehicle on grounds relating to its fuel tanks if such a vehicle satisfies the requirements set out in this Directive concerning fuel tanks."5. Article 3 shall be replaced by the following:"Article 3Any amendments necessary to adapt the requirements of the Annexes to technical progress, shall be adopted in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC."6. The list of Annexes and Annex I to Directive 70/221/EEC are hereby amended in accordance with the Annex to this Directive.Article 21. With effect from 3 May 2001, Member States shall accept compliance with the requirements of Directive 70/221/EEC, as amended by this Directive, for the purposes of Articles 4(1) and 7(1) of Directive 70/156/EEC.2. With effect from 3 May 2002, Member States:- shall no longer grant EC type-approval in accordance with Article 4(1) of Directive 70/156/EEC, and- may refuse national type-approval,for a new type of vehicle on grounds related to its fuel tanks if it fails to comply with the provisions of Directive 70/221/EEC, as amended by this Directive.3. With effect from 3 May 2003, Member States- shall consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 70/156/EEC as no longer valid for the purposes of Article 7(1) of that Directive, and- may refuse the sale, registration or entry into service of new vehicles which are not accompanied by a certificate of conformity valid in accordance with Directive 70/156/EEC, except where the provisions of Article 8(2) of that Directive are invoked,on grounds relating to the fuel tanks, if the requirements of Directive 70/221/EEC, as amended by this Directive, are not fulfilled.4. This Directive shall not invalidate any approval previously granted to vehicles having metal liquid fuel tanks nor prevent extensions of such approvals under the terms of the directive under which they were originally granted.Article 31. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 3 May 2001 and shall forthwith inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive.Article 4This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.Article 5This Directive is addressed to the Member States.Done at Brussels, 20 March 2000.For the European ParliamentThe PresidentN. FontaineFor the CouncilThe PresidentJ. Gama(1) OJ C 164, 29.5.1998, p. 16.(2) OJ C 407, 28.12.1998, p. 58.(3) Opinion of the European Parliament of 10 February 1999 (OJ C 150, 28.5.1999, p. 168), Council common position of 12 July 1999 (OJ C 249, 1.9.1999, p. 25), decision of the European Parliament of 27 October 1999 (not yet published in the Official Journal).(4) OJ L 76, 6.4.1970, p. 23. Directive as last amended by Commission Directive 97/19/EC (OJ L 125, 16.5.1997, p. 1).(5) OJ L 42, 23.2.1970, p. 1. Directive as last amended by Directive 98/91/EC of the European Parliament and of the Council (OJ L 11, 16.1.1999, p. 25).(6) OJ L 38, 11.2.1974, p. 2. Directive as last amended by Directive 78/632/EEC (OJ L 206, 29.7.1978, p. 26).ANNEXAMENDMENTS TO THE LIST OF ANNEXES AND TO ANNEX I TO DIRECTIVE 70/221/EECList of AnnexesThe indication regarding Annex I shall be replaced by the following: ">TABLE>"Annex IAnnex I shall be replaced by the following: "ANNEX ITANKS FOR LIQUID FUEL1. SCOPE1.1. This Annex applies to vehicles to which Directive 70/156/EEC applies.2. DEFINITIONSFor the purpose of this Annex:2.1. "Vehicle type with regard to fuel tanks", means vehicles which do not differ essentially in such respects as:2.1.1. The structure, shape, dimensions and materials (metal/plastic) of the tank(s);2.1.2. In vehicles of category M1(1) the position of the tank(s) in the vehicle in so far as it has a negative effect on the requirements of Section 5.10 of this Annex.2.2. "Occupant compartment", means the space for occupant accommodation bounded by the roof, floor, side walls, doors, outside glazing, front bulkhead and rear bulkhead.2.3. "Unladen mass", means the mass of the vehicle in running order as defined in Section 2.6 of Annex I to Directive 70/156/EEC.2.4. "Tank", means the tank(s) designed to contain the liquid fuel, as defined in Section 2.6, used primarily for the propulsion of the vehicle excluding its accessories (filler pipe (if it is a separate element), filler hole, cap, gauge, connections to the engine or to compensate interior excess pressure, etc).2.5. "Capacity of the tank", means the tank capacity as specified by the manufacturer.2.6. "Liquid fuel", means a fuel which is liquid in normal ambient conditions.3. APPLICATION FOR EC TYPE-APPROVAL3.1. The application for type-approval of a type of vehicle with regard to its fuel tanks pursuant to Article 3(4) of Directive 70/156/EEC shall be submitted by the vehicle manufacturer.3.2. A model for the information document is given in Appendix 3.3.3. The following must be submitted to the technical service responsible for conducting the type-approval tests:3.3.1. A vehicle representative of the vehicle type to be approved or the parts of the vehicle which the technical service deems necessary for approval tests;3.3.2. In the case of a vehicle equipped with a tank made of a plastic material: seven additional tanks, with their accessories;3.3.3. In the case of a vehicle equipped with a tank made of another material: two additional tanks, with their accessories.4. GRANTING OF EC TYPE-APPROVAL4.1. If the relevant requirements are satisfied, EC type-approval pursuant to Article 4(3) and, if applicable, Article 4(4) of Directive 70/156/EEC shall be granted.4.2. A model for the EC type-approval certificate is given in Appendix 4.4.3. An approval number in accordance with Annex VII to Directive 70/156/EEC shall be assigned to each type of vehicle approved. The same Member State shall not assign the same number to another type of vehicle.5. SPECIFICATIONS5.1. Tanks must be made so as to be corrosion-resistant.5.2. Tanks must satisfy, when equipped with all accessories which are normally attached to them, the leakage tests carried out according to Section 6.1 at a relative internal pressure equal to double the working excess pressure, but in any event not less than an excess pressure of 0,3 bar.Tanks for vehicles made of a plastic material are considered as meeting this requirement if they have passed the test described in Section 6.3.2.5.3. Any excess pressure or any pressure exceeding the working pressure must be compensated automatically by suitable devices (vents, safety valves, etc).5.4. The vents must be designed in such a way as to prevent any fire risk. In particular, any fuel which may leak when the tank(s) is (are) being filled must not be able to fall on the exhaust system. It shall be channelled to the ground.5.5. The tank(s) must not be situated in, or form, a surface (floor, wall, bulkhead) of the occupant compartment or other compartment integral with it.5.6. A partition must be provided to separate the occupant compartment from the tank(s). The partition may contain apertures (e. g. to accommodate cables) provided they are so arranged that fuel cannot flow freely from the tank(s) into the occupant compartment or other compartment integral with it during normal conditions of use.5.7. Every tank must be securely fixed and so placed as to ensure that any fuel leaking from the tank or its accessories will escape to the ground and not into the occupant compartment during normal conditions of use.5.8. The filler hole must not be situated in the occupant compartment, in the luggage compartment or in the engine compartment.5.9. The fuel must not escape through the tank cap or through the devices provided to compensate excess pressure during the foreseeable course of operation of the vehicle. In the case of overturning of the vehicle, a drip may be tolerated provided that it does not exceed 30 g/min; this requirement must be verified during the test prescribed in Section 6.2.5.9.1. The tank cap must be fixed to the filler pipe: the seal must be retained securely in place, the cap must latch securely in place against the seal and filler pipe when closed.5.9.1.1. The requirements of Section 5.9.1 will e deemed to be satisfied if the vehicle meets the requirements of Section 5.1.3 of Annex I to Directive 70/220/EEC(2), subject to the proviso that the examples listed in the third indent of that section do not apply to vehicles in categories other than M1 or N1.5.10. Tanks must be installed in such a way as to be protected from the consequences of an impact to the front or the rear of the vehicle; there shall be no protruding parts, sharp edges, etc. near the tank.5.11. The fuel tank and the filler neck shall be designed and installed in the vehicles in such a way as to avoid any accumulation of static electricity charges on their entire surface. If necessary, they shall be discharged into the metallic structure of the chassis or any major metallic mass by means of a good conductor.5.12. Moreover, tanks made of plastic material must also be tested according to the specific procedure set out in Section 6.3.6. TESTS6.1. Hydraulic testThe tank must be subjected to a hydraulic internal pressure test which must be carried out on an isolated unit complete with all its accessories. The tank must be completely filled with a non-flammable liquid (water, for example). After all communication with the outside has been cut off, the pressure must be gradually increased, through the pipe connection through which fuel is fed to the engine, to a relative internal pressure equal to double the working pressure used and in any case to not less than an excess pressure of 0,3 bar, which must be maintained for one minute. During this time the tank shell must not crack or leak; however, it may be permanently deformed.6.2. Overturn test6.2.1. The tank and all its accessories must be mounted on to a test fixture in a manner corresponding to the mode of installation on the vehicle for which the tank is intended; this also applies to systems for the compensation of the interior excess pressure.6.2.2. The test fixture shall rotate about an axis lying parallel to the longitudinal vehicle axis.6.2.3. The test will be carried out with the tank filled to 90 % of its capacity and also 30 % of its capacity with a non-flammable liquid having a density and a viscosity close to those of the fuel normally used (water may be accepted).6.2.4. The tank must be turned from its installed position 90° to the right. The tank must remain in this position for at least five minutes.The tank must then be turned 90° further in the same direction. The tank must be held in this position, in which it is completely inverted, for at least another five minutes.The tank must be rotated back to its normal position. Testing liquid which has not flowed back from the venting system into the tank must be drained and replenished if necessary.The tank must be rotated 90° in the opposite direction and left for at least five minutes in this position.The tank must be rotated 90° further in the same direction. This completely inverted position must be maintained for at least five minutes. Afterwards, the tank must be rotated back to its normal position.6.3. Additional tests for tank(s) for vehicles made of a plastic material6.3.1. Impact resistance6.3.1.1. The tank must be filled to its capacity with a water-glycol mixture or with another liquid having a low freezing point which does not change the properties of the tank material, and must then be subjected to a perforation test.6.3.1.2. During this test the tank temperature must be 233 K ± 2 K (- 40 °C ± 2 °C).6.3.1.3. A pendulum impact testing fixture must be used for the test. The impact body must be of steel and have the shape of a pyramid with equilateral-triangle faces and a square base, the summit and the edges being rounded to a radius of 3 mm. The centre of percussion of the pendulum must coincide with the centre of gravity of the pyramid; its distance from the axis of rotation of the pendulum must be 1 m. The total mass of the pendulum must be 15 kg. The energy of the pendulum at the moment of impact must be not less than 30 Nm and as close to that value as possible.6.3.1.4. The tests must be made on the points of the tank which are regarded as vulnerable to frontal or rear collisions. The points regarded as vulnerable are those which are most exposed or weakest having regard to the shape of the tank or the way in which it is installed on the vehicle. The points selected by the laboratories must be indicated in the test report.6.3.1.5. During the test, the tank must be held in position by the fittings on the side or sides opposite the side of impact. No leak must result from the test.6.3.1.6. At the choice of the manufacturer, all the impact tests may be carried out on one tank or each may be carried out on a different tank.6.3.2. Mechanical strengthThe tank must be tested under the conditions prescribed in Section 6.1 for leaks and for rigidity of shape. The tank and all its accessories must be mounted onto a test fixture in a manner corresponding to the mode of installation on the vehicle for which the tank is intended. Water at 326 K (53 °C) must be used as the testing fluid and must fill the tank to its capacity. The tank must be subjected to a relative internal pressure equal to double the working pressure and in any case to not less than 0,3 bar at a temperature of 326 K ± 2 K (53 °C ± 2 °C) for a period of five hours. During the test, the tank and its accessories must not crack or leak; however, it may be permanently deformed.6.3.3. Fuel permeability6.3.3.1. The fuel used for the permeability test must be either the reference fuel specified in Annex VIII to Directive 70/220/EEC or a commercial premium-grade fuel. If the tank is only designed for installation on vehicles with a compression-ignition engine, the tank shall be filled with diesel fuel.6.3.3.2. Prior to the test, the tank must be filled to 50 % of its capacity with testing fuel and stored, without being sealed, at an ambient temperature of 313 K ± 2 K (40 °C ± 2 °C) until the weight loss per unit time becomes constant.6.3.3.3. The tank must then be emptied and refilled to 50 % of its capacity with test fuel, after which it must be hermetically sealed and be stored at a temperature of 313 K ± 2 K (40 °C ± 2 °C). The pressure must be adjusted when the contents of the tank have reached the testing temperature. During the ensuing test period of eight weeks, the loss of weight due to diffusion during the test period shall be determined. The maximum permissible average loss of fuel is 20 g per 24 hours of testing time.6.3.3.4. If the loss due to diffusion exceeds the value indicated in Section 6.3.3.3, the test described there must be carried out again, on the same tank, to determine the loss by diffusion at 296 K ± 2 K (23 °C ± 2 °C), but under the same conditions otherwise. The loss so measured shall not exceed 10 g per 24 hours.6.3.4. Resistance to fuelAfter the test referred to in Section 6.3.3, the tank must still meet the requirements set out in Sections 6.3.1 and 6.3.2.6.3.5. Resistance to fireThe tank must be subjected to the following tests.6.3.5.1. For two minutes the tank, fixed as on the vehicle, must be exposed to flame. There must be no leakage of liquid fuel from the tank.6.3.5.2. Three tests must be made on different tanks filled with fuel as follows:6.3.5.2.1. If the tank is designed for installation on vehicles equipped with either a positive ignition engine or a compression ignition engine, three tests must be carried out with tanks filled with premium-grade gasoline;6.3.5.2.2. If the tank is only designed for installation on vehicles equipped with a compression-ignition engine, three tests must be carried out with tanks filled with diesel fuel;6.3.5.2.3. For each test the tank must be installed in a testing fixture simulating actual installation conditions as far as possible. The method whereby the tank is fixed in the fixture must correspond to the relevant specifications for the vehicle. Vehicle parts which protect the tank and its accessories against exposure to flame or which affect the course of the fire in any way, as well as specified components installed on the tank and plugs, must be taken into consideration. All openings must be closed during the test, but venting systems must remain operative. Immediately prior to the test the tank must be filled with the specified fuel to 50 % of its capacity.6.3.5.3. The flame to which the tank is exposed must be obtained by burning commercial fuel for positive-ignition engines (hereafter called "fuel") in a pan. The quantity of fuel poured into the pan shall be sufficient to permit the flame, under free-burning conditions, to burn for the whole test procedure.6.3.5.4. The pan dimensions must be chosen so as to ensure that the sides of the fuel tank are exposed to the flame. The pan must therefore exceed the horizontal projection of the tank by at least 20 cm, but not more then 50 cm. The side walls of the pan must not project more than 8 cm above the level of the fuel at the start of the test.6.3.5.5. The pan filled with fuel must be placed under the tank in such a way that the distance between the level of the fuel in the pan and the tank bottom corresponds to the design height of the tank above the road surface at the unladen mass (see Section 2.3). Either the pan, or the testing fixture, or both, must be freely movable.6.3.5.6. During phase C of the test, the pan must be covered by a screen placed 2 cm ± 1 cm above the fuel level. The screen must be made of a refractory material, as prescribed in Appendix 2. There must be no gap between the bricks and they must be supported over the fuel pan in such a manner that the holes in the bricks are not obstructed. The length and width of the frame must be 2 cm to 4 cm smaller than the interior dimensions of the pan so that a gap of 1 cm to 2 cm exists between the frame and the wall of the pan to allow ventilation.6.3.5.7. When the tests is carried out in the open air, sufficient wind protection must be provided and the wind velocity at fuel-pan level must not exceed 2,5 km/h. Before the test the screen must be heated to 308 K ± 5 K (35 °C ± 5 °C). The fire bricks may be wetted in order to guarantee the same test conditions for each successive test.6.3.5.8. The test must comprise four phases (see Appendix 1).6.3.5.8.1. Phase A: Pre-heating (figure 1)The fuel in the pan must be ignited at a distance of at least 3 m from the tank being tested. After 60 seconds pre-heating, the pan must be placed under the tank.6.3.5.8.2. Phase B: Direct exposure to flame (figure 2)For 60 seconds the tank must be exposed to the flame from the freely burning fuel.6.3.5.8.3. Phase C: Indirect exposure to flame (figure 3)As soon as phase B has been completed, the screen must be placed between the burning pan and the tank. The tank must be exposed to this reduced flame for a further 60 seconds.6.3.5.8.4. Phase D: End of test (figure 4)The burning pan covered with the screen must be moved back to its original position (phase A). If, at the end of the test, the tank is burning, the fire must be extinguished forthwith.6.3.5.9. The results of the test shall be considered satisfactory if no liquid fuel is leaking from the tank.6.3.6. Resistance to high temperature6.3.6.1. The fixture used for the test must match the manner of installation of the tank on the vehicle, including the way in which the tank vent works.6.3.6.2. The tank filled to 50 % of its capacity with water at 293 K (20 °C) must be subjected for one hour to an ambient temperature of 368 K ± 2 K (95 °C ± 2 °C).6.3.6.3. The results of the test shall be considered satisfactory if, after the test, the tank is not leaking or seriously deformed.6.3.7. Markings on the fuel tank6.3.7.1. The trade name or mark must be affixed to the tank; it must be indelible and clearly legible on the tank when the latter is installed on the vehicle.7. AMENDMENTS TO APPROVAL7.1. In the case of amendments to approvals granted pursuant to this Directive, the provisions of Article 5 of Directive 70/156/EEC shall apply.8. CONFORMITY OF PRODUCTION8.1. Measures to ensure the conformity of production shall be taken in accordance with the provisions laid down in Article 10 of Directive 70/156/EEC.(1) As defined in Annex II, Part A to Directive 70/156/EEC.(2) OJ L 76, 6.4.1970, p. 1.Appendix 1TEST OF RESISTANCE TO FIREFigure 1>PIC FILE= "L_2000106EN.001602.EPS">Figure 2>PIC FILE= "L_2000106EN.001603.EPS">Figure 3>PIC FILE= "L_2000106EN.001604.EPS">Figure 4>PIC FILE= "L_2000106EN.001605.EPS">Appendix 2DIMENSIONS AND TECHNICAL DATA OF FIREBRICKS>PIC FILE= "L_2000106EN.001702.EPS">>TABLE>Appendix 3>PIC FILE= "L_2000106EN.001802.EPS">Appendix 4>PIC FILE= "L_2000106EN.001902.EPS">>PIC FILE= "L_2000106EN.002001.EPS">>PIC FILE= "L_2000106EN.002002.EPS">"