Avis juridique important

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31981L0363

Council Directive 81/363/EEC of 28 April 1981 on aid to shipbuilding

Official Journal L 137 , 23/05/1981 P. 0039 Spanish special edition: Chapter 08 Volume 2 P. 0079  Portuguese special edition Chapter 08 Volume 2 P. 0079

++++COUNCIL DIRECTIVE  OF 28 APRIL 1981  ON AID TO SHIPBUILDING   ( 81/363/EEC )  THE COUNCIL OF THE EUROPEAN COMMUNITIES ,  HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY , AND IN PARTICULAR ARTICLES 92 ( 3 ) ( D ) AND 113 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 SITUATION OF THE SHIPBUILDING INDUSTRY HAS CONTINUED TO BE UNFAVOURABLE DURING THE PERIOD OF OPERATION OF COUNCIL DIRECTIVE 78/338/EEC OF 4 APRIL 1978 ON AID TO SHIPBUILDING ( 3 ) ; WHEREAS THIS SITUATION HAS IN PARTICULAR TAKEN THE FORM OF AN IMBALANCE BETWEEN THE PRODUCTION CAPACITY OF THE INDUSTRY AND DEMAND , LEADING TO LOW PRICE LEVELS ;  WHEREAS SHIPBUILDING UNDERTAKINGS IN THE COMMUNITY HAVE THEREFORE BEEN OBLIGED TO DRAW FREQUENTLY ON THEIR FINANCIAL RESERVES TO TAKE ORDERS , THUS REDUCING THEIR CHANCE OF IMPLEMENTING THE STRUCTURAL ADAPTATIONS NEEDED TO FACE THE PREVAILING MARKET CONDITIONS IN THE LONGER TERM ;  WHEREAS THE COUNCIL RESOLUTION OF 19 SEPTEMBER 1978 CONCERNING THE REORGANIZATION OF THE SHIPBUILDING INDUSTRY ( 4 ) STRESSED THE NEED TO MAINTAIN WITHIN THE COMMUNITY A HEALTHY AND COMPETITIVE SHIPBUILDING INDUSTRY WHOSE SCALE OF ACTIVITY SHOULD BE CONSISTENT WITH THE SIZE OF THE COMMUNITY'S SEABORNE TRADE AND RESPECT ITS ECONOMIC , SOCIAL AND STRATEGIC IMPORTANCE ;  WHEREAS A COMPETITIVE SHIPBUILDING INDUSTRY IS OF VITAL INTEREST TO THE COMMUNITY AND CONTRIBUTES TO ITS ECONOMIC AND SOCIAL DEVELOPMENT BY PROVIDING A SUBSTANTIAL MARKET FOR A RANGE OF INDUSTRIES , INCLUDING THOSE USING ADVANCED TECHNOLOGY ; WHEREAS IT CONTRIBUTES ALSO TO THE MAINTENANCE OF EMPLOYMENT IN A NUMBER OF REGIONS , INCLUDING SOME WHICH ARE ALREADY SUFFERING A HIGH RATE OF UNEMPLOYMENT ; WHEREAS THIS IS ALSO TRUE OF SHIP CONVERSION AND SHIP REPAIR ;  WHEREAS , IF THE SITUATION IN THE INDUSTRY WERE NORMAL , THE CONTINUATION OF OPERATING AID COULD NOT BE JUSTIFIED , SINCE , ITS EFFECT BEING MAINLY THAT OF CONSERVATION , IT IS NOT LIKELY TO BRING ABOUT ANY LASTING IMPROVEMENT IN THE COMMUNITY SHIPBUILDING INDUSTRY'S COMPETITIVENESS ;  WHEREAS , HOWEVER , THE CONTINUATION OF THE CRISIS HAS SERIOUS CONSEQUENCES FOR THE SHIPBUILDING INDUSTRY WHICH MAY MAKE THE IMMEDIATE ABOLITION OF SUCH AID IMPOSSIBLE ; WHEREAS IT IS NECESSARY TO ALLOW ADAPTATION OF THE STRUCTURES OF THE INDUSTRY TO THE PREVAILING MARKET CONDITIONS TO TAKE PLACE GRADUALLY ;  WHEREAS , TO THIS END , PRODUCTION AID SHOULD BE TEMPORARY AND DIMINISHING , SO AS TO ENCOURAGE THE UNDERTAKINGS TO MAKE THE NECESSARY EFFORT TO BECOME COMPETITIVE , AT LEAST IN TIME ; WHEREAS SUCH AID SHOULD BE SUBJECT TO CONTINUOUS CONTROL IN ORDER TO AVOID DISTORTIONS OF COMPETITION WITHIN THE COMMUNITY ; WHEREAS THE GRANTING OF SUCH AID SHOULD BE LINKED TO THE ACHIEVEMENT OF RESTRUCTURING OBJECTIVES ; WHEREAS , IN THIS CONTEXT , THE RESTRUCTURING EFFORT IS NOT CONFINED TO REDUCTION OF PRODUCTION , EMPLOYMENT AND PRODUCTION CAPACITY , BUT INCLUDES ALL OTHER MEASURES ENABLING THE SHIPBUILDING INDUSTRY TO BECOME COMPETITIVE ; WHEREAS IN ASSESSING THE REDUCTION OF PRODUCTION CAPACITY IT IS APPROPRIATE TO TAKE ACCOUNT OF THE EFFORT ALREADY MADE ;  WHEREAS , IN ORDER TO DEAL WITH THE PRESENT DIFFICULTIES FACING THE INDUSTRY , AND IN PARTICULAR THE DISTORTIONS OF COMPETITION WHICH ARE OCCURING , MOST MEMBER COUNTRIES OF THE OECD HAVE HELPED TO REMEDY THE SERIOUS STRUCTURAL DISEQUILIBRIUM BY REDUCING WORLD SHIPBUILDING PRODUCTION CAPACITY ; WHEREAS THIS REDUCTION IN CAPACITY SHOULD BE ACHIEVED IN THE LEAST DAMAGING AND MOST EQUITABLE WAY POSSIBLE ; WHEREAS THE MEMBER COUNTRIES HAVE ADAPTED CERTAIN CONDITIONS LAID DOWN BY THE OECD COUNCIL RESOLUTION ON CREDIT FACILITIES , IN ORDER TO BRING THE RESOLUTION MORE INTO LINE WITH THE CURRENT TREND OF THE MARKET ;  WHEREAS DIRECTIVE 78/338/EEC HAS HELPED TO REDUCE DISTORTION OF COMPETITION BETWEEN MEMBER STATES ; WHEREAS THIS DIRECTIVE HAS ALSO ENABLED THE COMMUNITY TO ADOPT A COMMON POSITION IN DISCUSSIONS WITH OTHER SHIPBUILDING COUNTRIES ;  WHEREAS PRODUCTION STRUCTURES SHOULD BE PROGRESSIVELY ADJUSTED TO THE NEW MARKET CONDITIONS IN SUCH A WAY THAT UNDERTAKINGS IN THE INDUSTRY MAY BECOME CAPABLE OF FOLLOWING GENERA ECONOMIC DEVELOPMENTS AND OF MEETING COMPETITION ON THE WORLD MARKET WITHOUT THE SUPPORT OF INTERVENTION BY PUBLIC AUTHORITIES ; WHEREAS THIS PROGRESSIVE ADJUSTMENT OF PRODUCTION STRUCTURES SHOULD BE ACCOMPANIED BY MEASURES TO FACILITATE ADJUSTMENTS IN EMPLOYMENT AND ON A SOCIAL LEVEL ;  WHEREAS , FURTHERMORE , EFFECTIVE ACTION TO ELIMINATE DISTORTIONS OF COMPETITION REQUIRES A SOLUTION COVERING ALL AID DIRECTLY OR INDIRECTLY AFFECTING COMPETITION AND TRADING CONDITIONS ON THE SHIPBUILDING , SHIP-CONVERSION AND SHIP-REPAIR MARKET ;  WHEREAS IT IS NECESSARY TO DEFINE AID INTENDED AS A TEMPORARY SOLUTION FOR THE RESCUE OF A SHIPBUILDING , SHIP CONVERSION OR SHIP REPAIR UNDERTAKING IN ORDER TO DEAL WITH ACUTE SOCIAL PROBLEMS ;  WHEREAS , IN VIEW OF THE CONTINUING CRISIS IN THE SHIPBUILDING INDUSTRY , IT IS APPROPRIATE TO PROVIDE FOR AID TO FACILITATE THE CONVERSION OR THE PARTIAL OR TOTAL CESSATION OF SHIPBUILDING ACTIVITIES UNDER THE MOST EQUITABLE SOCIAL CONDITIONS ; WHEREAS , TO THIS END . MEMBER STATES AND THE COMMISSION WILL CONTINUE TO COOPERATE IN ORDER TO DEAL AS FAR AS POSSIBLE WITH ANY SOCIAL PROBLEMS AND REGIONAL CONSEQUENCES WHICH MAY ARISE FROM THE RESTRUCTURING OF THE SHIPBUILDING AND SHIP-REPAIR INDUSTRIES ; WHEREAS MEMBER STATES WILL ENDEAVOUR TO INFORM THE COMMISSION AS SOON AS POSSIBLE IN PARTICULAR OF PLANS FOR THE CONVERSION AND PARTIAL OR TOTAL CESSATION OF SHIPBUILDING AND SHIP-REPAIR YARDS ;  WHEREAS AID GRANTED TO NATIONAL SHIPWNERS FOR THE ACQUISITION OF NEW SHIPS SHOULD NOT LEAD TO DISTORTIONS OF COMPETITION BETWEEN NATIONAL SHIPYARDS AND THOSE OF OTHER MEMBER STATES ;  WHEREAS ANY AID ELEMENTS CONTAINED IN THE FINANCING MEASURES TAKEN BY MEMBER STATES IN RESPECT OF THE SHIPBUILDING OR SHIP-REPAIR UNDERTAKINGS WHICH THEY DIRECTLY OR INDIRECTLY CONTROL SHOULD ALSO MEET THE REQUIREMENTS LAID DOWN UNDER THIS DIRECTIVE ,  HAS ADOPTED THIS DIRECTIVE :  ARTICLE 1  FOR THE PURPOSES OF ARTICLES 3 TO 10 THE FOLLOWING DEFINITIONS SHALL APPLY :   ( A ) " SHIPBUILDING " :  MEANS THE BUILDING IN THE COMMUNITY OF THE FOLLOWING METAL-HULLED SEA-GOING VESSELS :   - MERCHANT SHIPS FOR THE CARRIAGE OF PASSENGERS AND/OR CARGO , OF NOT LESS THAN 150 GROSS REGISTERED TONS ,   - FISHING VESSELS OF NOT LESS THAN 150 GROSS REGISTERED TONS ;   - DREDGERS OR SHIPS FOR OTHER WORK AT SEA , OF NOT LESS THAN 150 GROSS REGISTERED TONS , EXCLUDING DRILLING PLATFORMS ,   - TUGS OF NOT LESS THAN 365 KW ;   ( B ) " SHIP CONVERSION " :  MEANS THE CONVERSION OF METAL-HULLED SEA-GOING VESSELS OF NOT LESS THAN 1 000 GROSS REGISTERED TONS , ON CONDITION THAT CONVERSION OPERATIONS ENTAIL RADICAL ALTERATIONS TO THE CARGO PLAN , THE HULL OR THE PROPULSION SYSTEM ;   ( C ) " SHIP REPAIR " :  MEANS THE REPAIR OF THE VESSELS REFERRED TO UNDER  ( A ) ABOVE ;   ( D ) " SALE " :  MEANS ALL SALES OF VESSELS REFERRED TO UNDER ( A ) ABOVE ;   ( E ) " AID " :  MEANS STATE AID WITHIN THE MEANING OF ARTICLES 92 AND 93 OF THE TREATY , INCLUDING NOT ONLY AID GRANTED BY THE STATE ITSELF BUT ALSO THAT GRANTED BY REGIONAL OR LOCAL AUTHORITIES AND ANY AID ELEMENTS CONTAINED IN THE FINANCING MEASURES TAKEN BY MEMBER STATES IN RESPECT OF THE SHIPBUILDING OR SHIP-REPAIR UNDERTAKINGS WHICH THEY DIRECTLY OR INDIRECTLY CONTROL AND WHICH DO NOT COUNT AS THE PROVISION OF RISK CAPITAL ACCORDING TO STANDARD COMPANY PRACTICE IN A MARKET ECONOMY .  SUCH AID MAY BE CONSIDERED COMPATIBLE WITH THE COMMON MARKET PROVIDED THAT IT COMPLIES WITH THE CRITERIA FOR DEROGATION CONTAINED IN THIS DIRECTIVE .  ARTICLE 2  CREDIT FACILITIES  AID IN THE FORM OF CREDIT FACILITIES FOR ALL SALES OR CONVERSION OF VESSELS MAY BE CONSIDERED COMPATIBLE WITH THE COMMON MARKET PROVIDED THAT IT COMPLIES WITH THE OECD COUNCIL RESOLUTION OF 30 JANUARY 1980 OR WITH ANY AGREEMENTS REPLACING THE RESOLUTION .  ARTICLE 3  INVESTMENT AID  MEMBER STATES SHALL NOT GRANT SECTORIAL AID FOR THE CREATION OF NEW SHIPYARDS OR FOR INVESTMENT IN EXISTING YARDS IF SUCH AID WOULD BE LIKELY TO INCREASE THE MEMBER STATE'S BUILDING CAPACITY .  IN APPLYING GENERAL OR REGIONAL INVESTMENT AID SCHEMES TO THE SHIPBUILDING SECTOR , MEMBER STATES SHALL TAKE ALL STEPS TO ENSURE THAT AIDED INVESTMENT DOES NOT LEAD EITHER TO INCREASES IN THE CAPACITY OF THE SECTOR IN A MEMBER STATE , OR TO THE CREATION OF EMPLOYMENT WHICH IS NOT OF A STABLE NATURE . TO THIS END , PLANS FOR SUCH APPLICATION OF GENERAL OR REGIONAL AID SCHEMES LEADING TO INCREASES IN SHIPBUILDING CAPACITY IN A MEMBER STATE MUST BE COMMUNICATED TO THE COMMISSION NOT LESS THAN 30 WORKING DAYS BEFORE THEY ARE PUT INTO EFFECT .  MEMBER STATES SHALL INFORM THE COMMISSION OF THEIR DECISIONS TO GRANT AID FOR INVESTMENTS IN SHIPBUILDING , SHIP-CONVERSION OR SHIP-REPAIR YARDS WHERE THE AMOUNT OF SUCH INVESTMENT IS IN EXCESS OF FIVE MILLION EUROPEAN UNITS OF ACCOUNT . THIS INFORMATION SHALL BE PROVIDED IN ACCORDANCE WITH THE PROCEDURE PROVIDED FOR IN ARTICLE 10 .  ARTICLE 4  AID TO RESCUE AN UNDERTAKING  RESCUE AID INTENDED TO MAINTAIN A SHIPBUILDING , SHIP-CONVERSION OR SHIP-REPAIR UNDERTAKING , PENDING A DEFINITIVE SOLUTION OF THE PROBLEMS CONFRONTING THE UNDERTAKING CONCERNED , IN ORDER TO DEAL WITH ACUTE SOCIAL PROBLEMS AND THE REGIONAL EFFECTS WHICH MAY ARISE , MAY BE CONSIDERED COMPATIBLE WITH THE COMMON MARKET UNDER THIS DIRECTIVE .  THE COMMISSION SHALL VERIFY THAT THE AID DOES NOT CHANGE THE TERMS OF TRADE IN A MANNER CONTRARY TO THE COMMON INTEREST AND THAT IT DOES NOT ENDANGER THE ARRANGEMENTS INSTITUTED BY THE DIRECTIVE AND IN PARTICULAR ARTICLE 6 THEREOF .  ARTICLE 5  AID TO DEAL WITH THE SOCIAL AND REGIONAL CONSEQUENCES OF RESTRUCTURING  IN ORDER TO DEAL IN PARTICULAR WITH THE SOCIAL AND POSSIBLY REGIONAL CONSEQUENCES OF RESTRUCTURING , AID INTENDED TO COVER THE NORMAL EXPENDITURE OCCASIONED BY OPERATIONS FOR CONVERSION TO ACTIVITIES OTHER THAN THOSE SPECIFIED IN ARTICLE 1 ( A ) , ( B ) AND ( C ) OR BY PARTIAL OR TOTAL CLOSURE OF SHIPBUILDING OR SHIP-REPAIR YARDS MAY BE CONSIDERED COMPATIBLE WITH THE COMMON MARKET . IN ORDER TO ENABLE THE COMMISSION TO ASSESS THE CONSEQUENCES OF SUCH CONVERSION OPERATIONS OR CLOSURES , MEMBER STATES SHALL SUPPLY THE COMMISSION AT ITS REQUEST WITH ANY INFORMATION THEY HAVE ON THE MATTER .  ARTICLE 6  CRISIS AID  1 . PRODUCTION AID IN FAVOUR OF SHIPBUILDING MAY BE CONSIDERED COMPATIBLE WITH THE COMMON MARKET IF IT IS GRANTED TO DEAL WITH THE EFFECTS OF A CRISIS CHARACTERIZED BY A POOR ORDER SITUATION LEADING TO SUBSTANTIAL UNDER-UTILIZATION OF THE MEANS OF PRODUCTION .  SUCH AID SHALL BE PROGRESSIVELY REDUCED ; IT SHALL BE GRANTED ONLY IF LINKED TO THE ATTAINMENT OF INDUSTRIAL RESTRUCTURING OBJECTIVES WHICH WILL MAKE THE INDUSTRY COMPETITIVE AND ABLE ULTIMATELY TO OPERATE WITHOUT AID .  2 . WHEN ASSESSING THE COMPATIBILITY OF SUCH MEASURES WITH THE COMMON MARKET , AND IN PARTICULAR THE LEVEL OF AID , THE COMMISSION SHALL PAY PARTICULAR ATTENTION TO THE SITUATION ON THE MARKET , THE GRAVITY OF THE CRISIS IN TERMS OF THE BALANCE OF THE WORKLOAD REMAINING AVAILABLE TO SHIPYARDS AND THE NEED FOR ADAPTATION OF THE SHIPBUILDING INDUSTRY TO THE CONDITIONS AND CONSTRAINTS PREVAILING ON THE MARKET . IN ADDITION , THE COMMISSION SHALL VERIFY THAT THE PROGRAMME OF ADAPTATION OF THE INDUSTRY IS COMPARABLE WITH THOSE CARRIED OUT IN THE OTHER MEMBER STATES .  THIS ASSESSMENT SHALL TAKE ACCOUNT OF ALL THE AIDS WHICH THE MEMBER STATES CONCERNED PROVIDES FOR THE CONSTRUCTION , SALE AND ACQUISITION OF SHIPS , IN SO FAR AS THESE AIDS AFFECT THE SHIPBUILDING SECTOR . WHEN MAKING THIS EXAMINATION , THE COMMISSION SHALL ALSO TAKE ACCOUNT OF THE BUDGETARY FUNDS ALLOCATED TO THESE AIDS AS A WHOLE AND IN PARTICULAR CRISIS AIDS .  3 . THE COMMISSION SHALL ASSESS THE MAXIMUM LEVEL OF AID WHICH MAY BE GRANTED FOR THE APPLICATION OF THE VARIOUS AID SCHEMES . AUTHORIZATION TO EXCEED THIS LEVEL MAY BE GIVEN ONLY AS AN EXCEPTIONAL MEASURE , AFTER THE COMMISSION HAS BEEN NOTIFIED .  SUCH EXCEPTIONS MAY NOT BE PUT INTO EFFECT UNLESS THE COMMISSION HAS GIVEN ITS AGREEMENT . THE COMMISSION SHALL ADOPT A POSITION AS SOON AS POSSIBLE , HAVING REGARD TO THE URGENCY OF EACH INDIVIDUAL CASE , AND IN ANY CASE NOT LATER THAN 30 WORKING DAYS AFTER NOTIFICATION .  IN DETERMINING THE MANNER IN WHICH THE MAXIMUM LEVEL OF AID IS TO BE PROGRESSIVELY REDUCED , THE COMMISSION SHALL TAKE ACCOUNT OF THE EXISTING MAXIMUM LEVEL AND OF THE ACUTENESS OF THE CRISIS IN THE MEMBER STATE CONCERNED .  4 . THE COMMISSION SHALL BE GIVEN PRIOR NOTIFICATION OF ANY PROPOSED INDIVIDUAL AID UNDER THE MEASURES REFERRED TO IN PARAGRAPH 1 WHERE SUCH PROPOSAL IS IN COMPETITION WITH A TENDER FROM A YARD IN ANOTHER MEMBER STATE AND SHALL ADOPT A POSITION WITHIN 30 DAYS FOLLOWING NOTIFICATION . SUCH PROPOSALS MAY NOT BE IMPLEMENTED BEFORE THE COMMISSION HAS GIVEN ITS AGREEMENT . THE COMMISSION SHALL VERIFY THAT SUCH AID DOES NOT AFFECT TRADING CONDITIONS TO AN EXTENT CONTRARY TO THE COMMON INTEREST .  MEMBER STATES SHALL SUPPLY THE COMMISSION WITH A TABLE , FOR ITS EXCLUSIVE USE SETTING OUT THE DECISIONS ON THE AID REFERRED TO IN PARAGRAPH 1 AND AN ESTIMATE OF THEIR EFFECTS . THIS INFORMATION SHALL BE PROVIDED IN ACCORDANCE WITH THE PROCEDURE SET OUT IN ARTICLE 10 .  THE COMMISSION SHALL VERIFY , ON THE BASIS OF THE INFORMATION REFERRED TO IN THIS ARTICLE AND OF THE STATE OF THE ORDER BOOKS OF THE YARDS IN THE MEMBER STATE CONCERNED , WHETHER EFFORTS TO ATTAIN THE INDUSTRIAL RESTRUCTURING OBJECTIVES MENTIONED IN PARAGRAPH 1 AND THE CRISIS MEASURES WHICH HAVE BEEN APPLIED ARE CONTRIBUTING GENUINELY AND IN AN EQUITABLE MANNER TO THE ADAPTATION OF THE INDUSTRY TO THE NEW CONDITIONS ON THE WORLD SHIPBUILDING MARKET .  ARTICLE 7  AID AND INTERVENTION IN THE FORM OF COST-ESCALATION INSURANCE MAY BE CONSIDERED COMPATIBLE WITH THE COMMON MARKET UNDER THIS DIRECTIVE , SUBJECT TO THE CONDITIONS SET OUT IN ARTICLE 6 .  ARTICLE 8  1 . AID GRANTED TO SHIPOWNERS IN A MEMBER STATE LINKED TO THE ACQUISITION OF NEW SHIPS MAY NOT LEAD TO DISTORTIONS OF COMPETITION BETWEEN NATIONAL SHIPYARDS AND SHIPYARDS IN OTHER MEMBER STATES IN THE PLACING OF CONTRACTS .  2 . AID TO SHIPOWNERS LINKED TO THE ACQUISITION OF NEW SHIPS MAY NOT ENDANGER THE ARRANGEMENTS ESTABLISHED BY ARTICLE 6 IN PARTICULAR , NOR THE OBJECTIVES PURSUED BY THE PRESENT DIRECTIVE , ESPECIALLY IN REGARD TO THE ADAPTATION OF THE SHIPBUILDING INDUSTRY TO PREVAILING MARKET CONDITIONS .  3 . IF THE COMMISSION OBSERVES THAT ONE OF THESE SITUATIONS IS LIKELY TO ARISE , IT SHALL EXAMINE THE WHOLE OF THE AID PROVIDED BY A MEMBER STATE FOR THE BUILDING , SALE AND ACQUISITION OF SHIPS .  4 . THESE PROVISIONS ARE ENTIRELY WITHOUT PREJUDICE TO ANY FUTURE COMMUNITY RULES ON AID TO SHIPOWNERS .  5 . WHEN AID IS GRANTED TO NATIONAL SHIPOWNERS ON A SELECTIVE BASIS , MEMBER STATES SHALL DRAW UP A REPORT . THIS REPORT SHALL CONTAIN INFORMATION ON THE TOTAL TONNAGE OF ORDERS RECEIVING AID AND THE SHARE OF THIS TOTAL WHICH HAS BEEN PLACED IN NATIONAL YARDS . THE VOLUME OF AID SHALL BE SHOWN IN EACH CASE .  THIS INFORMATION SHALL BE PROVIDED IN ACCORDANCE WITH THE PROCEDURE SET OUT IN ARTICLE 10 . THE COMMISSION SHALL AT REGULAR INTERVALS DRAW UP OVERALL REPORTS SUMMARIZING THE INFORMATION SUPPLIED TO IT .  THESE REPORTS SHALL BE DISCUSSED WITH MEMBER STATES IN ORDER TO ENSURE THAT THERE IS NO DISCRIMINATION IN THE SHIPBUILDING INDUSTRY AS A RESULT OF SUCH AID .  ARTICLE 9  NO AIDS GRANTED PURSUANT TO THIS DIRECTIVE MAY BE CONDITIONAL UPON DISCRIMINATORY PRACTICES AS TO PRODUCTS ORIGINATING IN OTHER MEMBER STATES .  ARTICLE 10  SUBJECT TO THE SPECIFIC PROVISIONS OF THIS DIRECTIVE , ARTICLES 92 AND 93 OF THE EEC TREATY SHALL BE FULLY APPLICABLE TO SHIPBUILDING , SHIP CONVERSION AND SHIP REPAIR .  IN ACCORDANCE WITH ARTICLE 93 ( 3 ) OF THE TREATY , MEMBER STATES' AID PLANS , AS REFERRED TO IN THIS DIRECTIVE , SHALL BE NOTIFIED TO THE COMMISSION BEFORE THEY ARE PUT INTO EFFECT . THIS AID MAY NOT BE PUT INTO EFFECT BEFORE THE COMMISSION HAS GIVEN ITS AGREEMENT .  INFORMATION TO BE SUPPLIED PERIODICALLY BY MEMBER STATES UNDER THIS DIRECTIVE SHALL BE PROVIDED HALFYEARLY ON 1 MARCH IN RESPECT OF DECISIONS TAKEN DURING THE SECOND HALF OF THE PREVIOUS CALENDAR YEAR AND 1 SEPTEMBER IN RESPECT OF DECISIONS TAKEN DURING THE FIRST HALF OF THE CURRENT CALENDAR YEAR .  ON THE BASIS OF THE INFORMATION COMMUNICATED TO IT , THE COMMISSION SHALL , AT REGULAR INTERVALS , DRAW UP AN OVERALL REPORT TO SERVE AS A BASIS FOR DISCUSSION WITH NATIONAL EXPERTS . THIS REPORT SHALL STATE INTER ALIA THE MAXIMUM LEVEL OF AID OBTAINING IN EACH MEMBER STATE DURING THE PERIOD IN QUESTION .  THE MEMBER STATES SHALL AT REGULAR INTERVALS PROVIDE THE COMMISSION WITH A REPORT ON THE ATTAINMENT OF SHIPBUILDING RESTRUCTURING OBJECTIVES . THE COMMISSION SHALL INDICATE THE DATE BY WHICH EACH MEMBER STATE HAS TO SUBMIT THE REPORT . THE REPORT SHALL SHOW THE RESULTS OBTAINED THROUGH THE APPLICATION OF THE AID REFERRED TO IN THIS DIRECTIVE .  ARTICLE 11  THIS DIRECTIVE SHALL APPLY UNTIL 31 DECEMBER 1982 .  ARTICLE 12  THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .  DONE AT LUXEMBOURG , 28 APRIL 1981 .  FOR THE COUNCIL  THE PRESIDENT  J . DE KONING  ( 1 ) OJ NO C 28 , 9 . 2 . 1981 , P . 35 .  ( 2 ) OJ NO C 353 , 31 . 12 . 1980 , P . 25 .  ( 3 ) OJ NO L 98 , 11 . 4 . 1978 , P . 19 .  ( 4 ) OJ NO C 229 , 27 . 9 . 1978 , P . 1 .


Avis juridique important

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32003L0094

Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (Text with EEA relevance)

Official Journal L 262 , 14/10/2003 P. 0022 - 0026

Commission Directive 2003/94/ECof 8 October 2003laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(1), as last amended by Commission Directive 2003/63/EC(2), and in particular Article 47 thereof,Whereas:(1) All medicinal products for human use manufactured or imported into the Community, including medicinal products intended for export, are to be manufactured in accordance with the principles and guidelines of good manufacturing practice.(2) Those principles and guidelines are set out in Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use(3).(3) Article 13(3) of Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use(4) requires that detailed guidance be drawn up, in accordance with the guidelines on good manufacturing practice, on the elements to be taken into account when evaluating investigational medicinal products for human use with the object of releasing batches within the Community.(4) It is therefore necessary to extend and adapt the provisions of Directive 91/356/EEC to cover good manufacturing practice of investigational medicinal products.(5) Since most of the provisions of Directive 91/356/EEC need to be adjusted, for the sake of clarity that Directive should be replaced.(6) In order to ensure conformity with the principles and guidelines of good manufacturing practice, it is necessary to lay down detailed provisions on inspections by the competent authorities and on certain obligations of the manufacturer.(7) All manufacturers should operate an effective quality management system of their manufacturing operations, which requires the implementation of a pharmaceutical quality assurance system.(8) Principles and guidelines of good manufacturing practice should be set out in relation to quality management, personnel, premises and equipment, documentation, production, quality control, contracting out, complaints and product recall, and self-inspection.(9) In order to protect the human beings involved in clinical trials and to ensure that investigational medicinal products can be traced, specific provisions on the labelling of those products are necessary.(10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use, set up under Article 121 of Directive 2001/83/EC,HAS ADOPTED THIS DIRECTIVE:Article 1ScopeThis Directive lays down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use whose manufacture requires the authorisation referred to in Article 40 of Directive 2001/83/EC and in respect of investigational medicinal products for human use whose manufacture requires the authorisation referred to in Article 13 of Directive 2001/20/EC.Article 2DefinitionsFor the purposes of this Directive, the following definitions shall apply:1. "medicinal product" means any product as defined in Article 1(2) of Directive 2001/83/EC;2. "investigational medicinal product" means any product as defined in Article 2(d) of Directive 2001/20/EC;3. "manufacturer" means any person engaged in activities for which the authorisation referred to in Article 40(1) and (3) of Directive 2001/83/EC or the authorisation referred to in Article 13(1) of Directive 2001/20/EC is required;4. "qualified person" means the person referred to in Article 48 of Directive 2001/83/EC or in Article 13(2) of Directive 2001/20/EC;5. "pharmaceutical quality assurance" means the total sum of the organised arrangements made with the object of ensuring that medicinal products or investigational medicinal products are of the quality required for their intended use;6. "good manufacturing practice" means the part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use;7. "blinding" means the deliberate disguising of the identity of an investigational medicinal product in accordance with the instructions of the sponsor;8. "unblinding" means the disclosure of the identity of a blinded product.Article 3Inspections1. By means of the repeated inspections referred to in Article 111(1) of Directive 2001/83/EC and by means of the inspections referred to in Article 15(1) of Directive 2001/20/EC, the Member States shall ensure that manufacturers respect the principles and guidelines of good manufacturing practice laid down by this Directive. Member States shall also take into account the compilation, published by the Commission, of Community procedures on inspections and exchange of information.2. For the interpretation of the principles and guidelines of good manufacturing practice, the manufacturers and the competent authorities shall take into account the detailed guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC, published by the Commission in the "Guide to good manufacturing practice for medicinal products and for investigational medicinal products".Article 4Conformity with good manufacturing practice1. The manufacturer shall ensure that manufacturing operations are carried out in accordance with good manufacturing practice and with the manufacturing authorisation. This provision shall also apply to medicinal products intended only for export.2. For medicinal products and investigational medicinal products imported from third countries, the importer shall ensure that the products have been manufactured in accordance with standards which are at least equivalent to the good manufacturing practice standards laid down by the Community.In addition, an importer of medicinal products shall ensure that such products have been manufactured by manufacturers duly authorised to do so. An importer of investigational medicinal products shall ensure that such products have been manufactured by a manufacturer notified to the competent authorities and accepted by them for that purpose.Article 5Compliance with marketing authorisation1. The manufacturer shall ensure that all manufacturing operations for medicinal products subject to a marketing authorisation are carried out in accordance with the information provided in the application for marketing authorisation as accepted by the competent authorities.In the case of investigational medicinal products, the manufacturer shall ensure that all manufacturing operations are carried out in accordance with the information provided by the sponsor pursuant to Article 9(2) of Directive 2001/20/EC as accepted by the competent authorities.2. The manufacturer shall regularly review his manufacturing methods in the light of scientific and technical progress and the development of the investigational medicinal product.If a variation to the marketing authorisation dossier or an amendment to the request referred to in Article 9(2) of Directive 2001/20/EC is necessary, the application for modification shall be submitted to the competent authorities.Article 6Quality assurance systemThe manufacturer shall establish and implement an effective pharmaceutical quality assurance system, involving the active participation of the management and personnel of the different departments.Article 7Personnel1. At each manufacturing site, the manufacturer shall have a sufficient number of competent and appropriately qualified personnel at his disposal to achieve the pharmaceutical quality assurance objective.2. The duties of the managerial and supervisory staff, including the qualified persons, responsible for implementing and operating good manufacturing practice, shall be defined in job descriptions. Their hierarchical relationships shall be defined in an organisation chart. Organisation charts and job descriptions shall be approved in accordance with the manufacturer's internal procedures.3. The staff referred to in paragraph 2 shall be given sufficient authority to discharge their responsibility correctly.4. The personnel shall receive initial and ongoing training, the effectiveness of which shall be verified, covering in particular the theory and application of the concept of quality assurance and good manufacturing practice, and, where appropriate, the particular requirements for the manufacture of investigational medicinal products.5. Hygiene programmes adapted to the activities to be carried out shall be established and observed. These programmes shall, in particular, include procedures relating to health, hygiene practice and clothing of personnel.Article 8Premises and equipment1. Premises and manufacturing equipment shall be located, designed, constructed, adapted and maintained to suit the intended operations.2. Premises and manufacturing equipment shall be laid out, designed and operated in such a way as to minimise the risk of error and to permit effective cleaning and maintenance in order to avoid contamination, cross contamination and, in general, any adverse effect on the quality of the product.3. Premises and equipment to be used for manufacturing operations, which are critical to the quality of the products, shall be subjected to appropriate qualification and validation.Article 9Documentation1. The manufacturer shall establish and maintain a documentation system based upon specifications, manufacturing formulae and processing and packaging instructions, procedures and records covering the various manufacturing operations performed. Documents shall be clear, free from error and kept up to date. Pre-established procedures for general manufacturing operations and conditions shall be kept available, together with specific documents for the manufacture of each batch. That set of documents shall enable the history of the manufacture of each batch and the changes introduced during the development of an investigational medicinal product to be traced.For a medicinal product, the batch documentation shall be retained for at least one year after the expiry date of the batches to which it relates or at least five years after the certification referred to in Article 51(3) of Directive 2001/83/EC, whichever is the longer period.For an investigational medicinal product, the batch documentation shall be retained for at least five years after the completion or formal discontinuation of the last clinical trial in which the batch was used. The sponsor or marketing authorisation holder, if different, shall be responsible for ensuring that records are retained as required for marketing authorisation in accordance with the Annex I to Directive 2001/83/EC, if required for a subsequent marketing authorisation.2. When electronic, photographic or other data processing systems are used instead of written documents, the manufacturer shall first validate the systems by showing that the data will be appropriately stored during the anticipated period of storage. Data stored by those systems shall be made readily available in legible form and shall be provided to the competent authorities at their request. The electronically stored data shall be protected, by methods such as duplication or back-up and transfer on to another storage system, against loss or damage of data, and audit trails shall be maintained.Article 10Production1. The different production operations shall be carried out in accordance with pre-established instructions and procedures and in accordance with good manufacturing practice. Adequate and sufficient resources shall be made available for the in-process controls. All process deviations and product defects shall be documented and thoroughly investigated.2. Appropriate technical or organisational measures shall be taken to avoid cross contamination and mix-ups. In the case of investigational medicinal products, particular attention shall be paid to the handling of products during and after any blinding operation.3. For medicinal products, any new manufacture or important modification of a manufacturing process of a medicinal product shall be validated. Critical phases of manufacturing processes shall be regularly re-validated.4. For investigational medicinal products, the manufacturing process shall be validated in its entirety in so far as is appropriate, taking into account the stage of product development. At least the critical process steps, such as sterilisation, shall be validated. All steps in the design and development of the manufacturing process shall be fully documented.Article 11Quality control1. The manufacturer shall establish and maintain a quality control system placed under the authority of a person who has the requisite qualifications and is independent of production.That person shall have at his disposal, or shall have access to, one or more quality control laboratories appropriately staffed and equipped to carry out the necessary examination and testing of the starting materials and packaging materials and the testing of intermediate and finished products.2. For medicinal products, including those imported from third countries, contract laboratories may be used if authorised in accordance with Article 12 of this Directive and point (b) of Article 20 of Directive 2001/83/EC.For investigational medicinal products, the sponsor shall ensure that the contract laboratory complies with the content of the request referred to in Article 9(2) of Directive 2001/20/EC, as accepted by the competent authority. When the products are imported from third countries, analytical control shall not be mandatory.3. During the final control of the finished product before its release for sale or distribution or for use in clinical trials, the quality control system shall take into account, in addition to analytical results, essential information such as the production conditions, the results of in-process controls, the examination of the manufacturing documents and the conformity of the product to its specifications, including the final finished pack.4. Samples of each batch of finished medicinal product shall be retained for at least one year after the expiry date.For an investigational medicinal product, sufficient samples of each batch of bulk formulated product and of key packaging components used for each finished product batch shall be retained for at least two years after completion or formal discontinuation of the last clinical trial in which the batch was used, whichever period is the longer.Unless a longer period is required under the law of the Member State of manufacture, samples of starting materials, other than solvents, gases or water, used in the manufacturing process shall be retained for at least two years after the release of product. That period may be shortened if the period of stability of the material, as indicated in the relevant specification, is shorter. All those samples shall be maintained at the disposal of the competent authorities.Other conditions may be defined, by agreement with the competent authority, for the sampling and retaining of starting materials and certain products manufactured individually or in small quantities, or when their storage could raise special problems.Article 12Work contracted out1. Any manufacturing operation or operation linked thereto which is carried out under contract shall be the subject of a written contract.2. The contract shall clearly define the responsibilities of each party and shall define, in particular, the observance of good manufacturing practice to be followed by the contract-acceptor and the manner in which the qualified person responsible for certifying each batch is to discharge his responsibilities.3. The contract-acceptor shall not subcontract any of the work entrusted to him under the contract without written authorisation from the contract-giver.4. The contract-acceptor shall comply with the principles and guidelines of good manufacturing practice and shall submit to inspections carried out by the competent authorities pursuant to Article 111 of Directive 2001/83/EC and Article 15 of Directive 2001/20/EC.Article 13Complaints, product recall and emergency unblinding1. In the case of medicinal products, the manufacturer shall implement a system for recording and reviewing complaints together with an effective system for recalling, promptly and at any time, medicinal products in the distribution network. Any complaint concerning a defect shall be recorded and investigated by the manufacturer. The manufacturer shall inform the competent authority of any defect that could result in a recall or abnormal restriction on supply and, in so far as is possible, indicate the countries of destination.Any recall shall be made in accordance with the requirements referred to in Article 123 of Directive 2001/83/EC.2. In the case of investigational medicinal products, the manufacturer shall, in cooperation with the sponsor, implement a system for recording and reviewing complaints together with an effective system for recalling promptly and at any time investigational medicinal products which have already entered the distribution network. The manufacturer shall record and investigate any complaint concerning a defect and shall inform the competent authority of any defect that could result in a recall or abnormal restriction on supply.In the case of investigational medicinal products, all trial sites shall be identified and, in so far as is possible, the countries of destination shall be indicated.In the case of an investigational medicinal product for which a marketing authorisation has been issued, the manufacturer of the investigational medicinal product shall, in cooperation with the sponsor, inform the marketing authorisation holder of any defect that could be related to the authorised medicinal product.3. The sponsor shall implement a procedure for the rapid unblinding of blinded products, where this is necessary for a prompt recall as referred to in paragraph 2. The sponsor shall ensure that the procedure discloses the identity of the blinded product only in so far as is necessary.Article 14Self-inspectionThe manufacturer shall conduct repeated self-inspections as part of the quality assurance system in order to monitor the implementation and respect of good manufacturing practice and to propose any necessary corrective measures. Records shall be maintained of such self-inspections and any corrective action subsequently taken.Article 15LabellingIn the case of an investigational medicinal product, labelling shall be such as to ensure protection of the subject and traceability, to enable identification of the product and trial, and to facilitate proper use of the investigational medicinal product.Article 16Repeal of Directive 91/356/EECDirective 91/356/EEC is repealed.References to the repealed Directive shall be construed as references to this Directive.Article 17Transposition1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 April 2004 at the latest. They shall forthwith communicate to the Commission the text of the provisions and correlation table between those provisions and the provisions of this Directive.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. The 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 18Entry into forceThis Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.Article 19AddresseesThis Directive is addressed to the Member States.Done at Brussels, 8 October 2003.For the CommissionErkki LiikanenMember of the Commission(1) OJ L 311, 28.11.2001, p. 67.(2) OJ L 159, 27.6.2003, p. 46.(3) OJ L 193, 17.7.1991, p. 30.(4) OJ L 121, 1.5.2001, p. 34.


Avis juridique important

|

31996L0060

Commission Directive 96/60/EC of 19 September 1996 implementing Council Directive 92/75/EEC with regard to energy labelling of household combined washer-driers

Official Journal L 266 , 18/10/1996 P. 0001 - 0027

COMMISSION DIRECTIVE 96/60/EC of 19 September 1996 implementing Council Directive 92/75/EEC with regard to energy labelling of household combined washer-driersTHE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 92/75/EEC of 22 September 1992 on the indication by labelling and standard product information of the consumption of energy and other resources of household appliances (1), and in particular Articles 9 and 12 thereof,Whereas electricity use by combined washer-driers accounts for a significant part of total Community energy demand; whereas the scope for reduced energy use by these appliances is substantial;Whereas a better washing performance often requires a higher consumption of water and energy; whereas information on the washing performance of an appliance is helpful in evaluating the information on its energy and water consumption; whereas this will help consumers make a choice of appliance which is consistent with the rational use of energy;Whereas the Community, confirming its interest in an international standardization system capable of producing standards that are actually used by all partners in international trade and of meeting the requirements of Community policy, invites the European standards organizations to continue their cooperation with international standards organizations;Whereas the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are the bodies recognized as competent to adopt harmonized standards in accordance with the general guidelines for cooperation between the Commission and these two bodies signed on 13 November 1984; whereas, within the meaning of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted by Cenelec, on the basis of a remit (mandate) from the Commission in accordance with the provisions of 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 (2), as last amended by Commission Decision 96/139/EEC (3), and on the basis of those general guidelines;Whereas the measures provided for in this Directive are in accordance with the opinion of the committee set up under Article 10 of Directive 92/75/EEC,HAS ADOPTED THIS DIRECTIVE:Article 11. This Directive shall apply to electric mains operated household combined washer-driers. Appliances that can also use other energy sources are excluded.2. The information required by this Directive shall be measured in accordance with harmonized standards, the reference numbers of which have been published in the Official Journal of the European Communities and for which Member States have published the reference numbers of the national standards transposing those harmonized standards. Throughout this Directive any provisions requiring the giving of information relating to noise shall apply only where that information is required pursuant to Article 3 of Council Directive 86/594/EEC (4). This information, where required, shall be measured in accordance with that Directive.3. The harmonized standards referred to in paragraph 2 shall be drawn up under mandate from the Commission in accordance with Directive 83/189/EEC.4. In this Directive, except where the context otherwise requires, expressions used have the same meaning as in Directive 92/75/EEC.Article 21. The technical documentation referred to in Article 2 (3) of Directive 92/75/EEC shall include:- the name and address of the supplier,- a general description of the model, sufficient for it to be uniquely identified,- information, including drawings as relevant, on the main design features of the model and in particular items which appreciably affect its energy consumption,- reports of relevant measurement tests carried out on the model under the test procedures of the harmonized standards referred to in Article 1 (2) of this Directive,- operating instructions, if any.2. The label referred to in Article 2 (1) of Directive 92/75/EEC shall be as specified in Annex I to this Directive. The label shall be placed on the outside of the front or top of the appliance, in such a way as to be clearly visible and not obscured.3. The content and format of the fiche referred to in Article 2 (1) of Directive 92/75/EEC shall be as specified in Annex II to this Directive.4. In the circumstances covered by Article 5 of Directive 92/75/EEC, and where the offer for sale, hire or hire purchase is provides by means of a printed communication, such as a mail order catalogue, then that printed communication shall include all the information specified in Annex III to this Directive.5. The energy efficiency class of an appliance, and its washing performance class, shall be as determined in accordance with Annex IV.Article 3Member States shall take all necessary measures to ensure that all suppliers and dealers established in their territory fulfil their obligations under this Directive.Article 41. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 15 July 1997. They shall immediately inform the Commission thereof. They shall apply those provisions from 1 August 1997.However, Member States shall, until 31 January 1998, permit:- the placing on the market, the commercialization and/or the display of products and- the distribution of printed communications referred to in Article 2 (4)which do not conform with this Directive.When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive.Article 5This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.Article 6This Directive is addressed to the Member States.Done at Brussels, 19 September 1996.For the CommissionChristos PAPOUTSISMember of the Commission(1) OJ No L 297, 13. 10. 1992, p. 16.(2) OJ No L 109, 26. 4. 1983, p. 8.(3) OJ No L 32, 10. 2. 1996, p. 31.(4) OJ No L 334, 6. 12. 1986, p. 24.ANNEX I THE LABEL Label design 1. The label shall be the relevant language version, chosen from the following illustrations:>REFERENCE TO A GRAPHIC>>REFERENCE TO A FILM>>REFERENCE TO A FILM>>REFERENCE TO A FILM>>REFERENCE TO A FILM>>REFERENCE TO A FILM>>REFERENCE TO A FILM>>REFERENCE TO A FILM>>REFERENCE TO A FILM>>REFERENCE TO A FILM>>REFERENCE TO A FILM>>REFERENCE TO A FILM>2. The following notes define the information to be included:Note:I. Supplier's name or trade mark.II. Supplier's model identifier.III. The energy efficiency class of the model, determined in accordance with Annex IV. This indicator letter shall be placed at the same level as the relevant arrow.IV. Without prejudice to any requirements under the Community Eco-label scheme, where a model has been granted a 'Community Eco-label` pursuant to Council Regulation (EEC) No 880/92 (1), a copy of the Eco-label may be added here. The 'washer-drier label design guide` referred to below, explains how the Eco-label may be included in the label.V. Energy consumption in kWh per complete operating (washing, spinning and drying) cycle using standard 60° C cotton cycle, and 'dry cotton` drying cycle, determined in accordance with the test procedures of the harmonized standards referred to in Article 1 (2).VI. Energy consumption in kWh per washing (washing and spinning only) cycle using standard 60° C cotton cycle, determined in accordance with the test procedures of the harmonized standards referred to in Article 1 (2).VII. Washing performance class determined in accordance with Annex IV.VIII. Maximum spin speed attained for standard 60° C cotton cycle, determined in accordance with the test procedures of the harmonized standards referred to in Article 1 (2).IX. Capacity (in kg) of appliance for standard 60° C cotton cycle (without drying), determined in accordance with the harmonized standards referred to in Article 1 (2).X. Capacity (in kg) of appliance for 'dry cotton` (drying) cycle, determined in accordance with the harmonized standards referred to in Article 1 (2).XI. Water consumption, in litres, per complete operating (washing, spinning and drying) cycle using standard 60° C cotton washing cycle and 'dry cotton` drying cycle, determined in accordance with the test procedures of the harmonized standards referred to in Article 1 (2).XII. Where applicable, noise during washing, spinning and drying cycles using standard 60° C cotton washing cycle and 'dry cotton` drying cycle, determined in accordance with Council Directive 86/594/EEC (2).Note:The equivalent terms in other languages to those given above are set out in Annex V.Printing 3. The following defines certain aspects of the label:>REFERENCE TO A GRAPHIC>>REFERENCE TO A FILM>Colours used:CMYK cyan, magenta, yellow, black.Ex. 07X0: 0 % cyan, 70 % magenta, 100 % yellow, 0 %black.Arrows- A: X0X0- B: 70X0- C: 30X0- D: 00X0- E: 03X0- F: 07X0- G: 0XX0Outline colour X070All text is in black. The background is white.Complete printing information is contained in a 'Washer-drier energy label design guide`, which is for information only, obtainable from:The Secretary of the Committee on energy labelling and standard product information for household appliances,Directorate-General Energy XVII,European Commission,Rue de la Loi/Wetstraat 200,B-1049 Brussels.(1) OJ No L 99, 11. 4. 1992, p. 1.(2) OJ No L 344, 6. 12, 1986, p. 24. The relevant noise measurement standards are EN 60704-2-4 for washing and spinning, and EN 60704-2-6 for drying and EN 60704-3.ANNEX II THE FICHE The fiche shall contain the following information. The information may be given in the form of a table covering a number of models supplied by the same supplier. The information shall be given in the order specified below unless it is contained in a more general description of the appliance:1. Supplier's trade mark.2. Supplier's model identifier.3. The energy efficiency class of the model determined in accordance with Annex IV. Expressed as 'Energy efficiency class . . . on a scale of A (more efficient) to G (less efficient)`. Where this information is provided in a table this may be expressed by other means provides it is clear that the scale is from A (more efficient) to G (less efficient).4. Where the information is provides in a table, and where some of the appliances listed in the table have been granted a 'Community Eco-label` pursuant to Regulation (EEC) No 880/92, this information may be included here. In this case the row heading shall state 'Community Eco-label`, and the entry shall consist of a copy of the Eco-label mark. This provision is without prejudice to any requirements under the EU Eco-label scheme.5. Energy consumption for washing, spinning, and drying, in kWh per complete operating cycle as defined in Annex I note V.6. Energy consumption for washing and spinning only, in kWh per washing cycle as defined in Annex I note VI.7. Washing performance class determined in accordance with Annex IV. Expressed as 'Washing performance class . . . on a scale of A (higher) to G (lower)`. This may be expressed by other means provided it is clear that the scale is from A (higher) to G (lower).8. Water extraction efficiency for a standard 60° C cotton washing cycle, determined in accordance with the test procedures of the harmonized standards referred to in Article 1 (2). Expressed as 'Water remaining after spin . . . % (as a proportion of dry weight of wash)`.9. Maximum spin speed attained as defined in Annex I note VIII.10. Washing capacity of appliance for a standard 60° C cotton washing cycle, as defined in Annex I note IX.11. Drying capacity of appliance for a standard 'dry cotton` drying cycle, as defined in Annex I note X.12. Water consumption for washing, spinning and drying, in litres per complete operating cycle as defined in Annex I note XI.13. Water consumption for washing and spinning only, in litres, per standard 60° C cotton washing (and spinning) cycle determined in accordance with the test procedures of the harmonized standards referred to in Article 1 (2).14. Washing and drying time. Programme time for complete operating cycle (60° C cotton washing and 'dry cotton` drying), for rated washing capacity, determined in accordance with the test procedures of the harmonized standards referred to in Article 1 (2).15. Suppliers may include information under points 5 to 14 above in respect of other wash and/or drying cycles.16. The consumption of energy and water equal to 200 times the consumption expressed in points 5 (energy) and 12 (water). This shall be expressed as 'estimated annual consumption for a four-person household, always using the drier (200 cycles)`.17. The consumption of energy and water equal to 200 times the consumption expressed in points 6 (energy) and 13 (water). This shall be expressed as 'estimated annual consumpting for four-person household, never using the drier (200 cycles)`.18. Where applicable, noise during washing, spinning and drying cycles using standard 60° C cotton washing cycle and 'dry cotton` drying cycle, in accordance with Directive 86/594/EEC.The information on the label may be given in the form of a representation of the label in colour or in black and white.Note:The equivalent terms in other languages to those given above are set out in Annex V.ANNEX III MAIL ORDER AND OTHER DISTANCE SELLING Mail order catalogues and other printed communications referred to in Article 2 (4) shall contain the following information, given in the order specified:1. Energy efficiency class (Annex II point 3)2. Energy consumption (washing, spinning and drying) (Annex II point 5)3. Energy consumption (washing and spinning only) (Annex II point 6)4. Washing performance class (Annex II point 7)5. Water extraction efficiency (Annex II point 8)6. Maximum spin speed (Annex II point 9)7. Capacity (washing) (Annex II point 10)8. Capacity (drying) (Annex II point 11)9. Water consumption (washing, spinning and drying) (Annex II point 12)10. Water consumption (washing and spinning only) (Annex II point 13)11. Estimated annual consumption for a four-person household, always using the drier (200 cycles) (Annex II point 16)12. Estimated annual consumption for a four-person household, never using the drier (200 cycles) (Annex II point 17)13. Noise, where applicable (Annex II point 18)Where other information contained in the fiche is provided, it shall be in the form specified in Annex II and shall be included in the above table in the order required for the fiche.Note:The equivalent terms in other languages to those given above are set out in Annex V.ANNEX IV ENERGY EFFICIENCY CLASS 1. The energy efficiency class of an appliance shall be determined in accordance with Table 1:>TABLE>2. The washing performance class of an appliance shall be determined in accordance with Table 2:>TABLE>ANNEX V >TABLE>


title: Council Directive 2006/108/EC of 20 November 2006 adapting Directives 90/377/EEC and 2001/77/EC in the field of energy, by reason of the accession of Bulgaria and Romania

text:
               20.12.2006

               EN

               Official Journal of the European Union

               L 363/414

      COUNCIL DIRECTIVE 2006/108/EC
   of 20 November 2006
   adapting Directives 90/377/EEC and 2001/77/EC in the field of energy, by reason of the accession of Bulgaria and Romania
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community,
   Having regard to the Treaty of Accession of Bulgaria and Romania (1), and in particular Article 4(3) thereof,
   Having regard to the Act of Accession of Bulgaria and Romania, and in particular Article 56 thereof,
   Having regard to the proposal from the Commission,
   Whereas:

               (1)

               Pursuant to Article 56 of the Act of Accession, where acts of the institutions remain valid beyond 1 January 2007, and require adaptation by reason of accession, and the necessary adaptations have not been provided for in the Act of Accession or its Annexes, the necessary acts are to be adopted by the Council, unless the Commission adopted the original act.

               (2)

               The Final Act of the Conference which drew up the Treaty of Accession indicated that the High Contracting Parties had reached political agreement on a set of adaptations to acts adopted by the institutions required by reason of accession and invited the Council and the Commission to adopt these adaptations before accession, completed and updated where necessary to take account of the evolution of the law of the Union.

               (3)

               Directives 90/377/EEC (2) and 2001/77/EC (3) should therefore be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Directives 90/377/EEC and 2001/77/EC shall be amended as set out in the Annex.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by the date of accession of Bulgaria and Romania to the European Union at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, 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 covered by this Directive.
   Article 3
   This Directive shall enter into force subject to and on the date of the entry into force of the Treaty of Accession of Bulgaria and Romania.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 20 November 2006

            For the Council

            The President

         J. KORKEAOJA

      (1)  OJ L 157, 21.6.2005, p. 11.

      (2)  OJ L 185, 17.7.1990, p. 16.

      (3)  OJ L 283, 27.10.2001, p. 33.

      ANNEX
      ENERGY

                  1.

                  31990 L 0377: Council Directive 90/377/EEC of 29 June 1990 concerning a Community procedure to improve the transparency of gas and electricity prices charged to industrial end-users (OJ L 185, 17.7.1990, p. 16), as amended by:

                              —

                              31993 L 0087: Commission Directive 93/87/EEC of 22.10.1993 (OJ L 277, 10.11.1993, p. 32),

                              —

                              11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

                              —

                              12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),

                              —

                              32003 R 1882: Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29.9.2003 (OJ L 284, 31.10.2003, p. 1).

                              (a)

                              The following are inserted in Annex I, paragraph 11:
                              ‘—   Bulgaria: Sofia,’
                              ‘—   Romania: Bucharest,’;

                              (b)

                              the following are inserted in Annex II, point I.(2):
                              ‘—   Bulgaria: the country as a whole,’
                              ‘—   Romania: the country as a whole’.

                  2.

                  32001 L 0077: Directive 2001/77/EC of the European Parliament and of the Council of 27 September 2001 on the promotion of electricity produced from renewable energy sources in the internal electricity market (OJ L 283, 27.10.2001, p. 33), as amended by:

                              —

                              12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).

                              (a)

                              In the Annex the following is inserted after the entry for Belgium:

                                          ‘Bulgaria

                                          1,7

                                          6

                                          11(7)’

                                    and, after the entry for Portugal:

                                          ‘Romania

                                          14,9

                                          28

                                          33’

                              (b)

                              in the Annex, the entry for the Community is replaced by the following:

                                          ‘Community

                                          372

                                          13,2

                                          21’

                              (c)

                              in the Annex, footnotes (**) and (***) are replaced by the following:

                                          ‘(**)

                                          Data refer to the national production of RES-E in 1997, except for the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia where data refer to 1999, and for Bulgaria and Romania where data refers to 2001.

                                          (***)

                                          The percentage contributions of RES-E in 1997 (in 1999-2000 for the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia, in 2001 for Bulgaria and Romania) and 2010 are based on the national production of RES-E divided by the gross national electricity consumption. For the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia, gross national electricity consumption is based on 2000 data. For Bulgaria and Romania gross national electricity consumption is based on 2001 data. In the case of internal trade of RES-E (with recognised certification or origin registered) the calculation of these percentages will influence 2010 figures by Member State but not the Community total.’.

                              (d)

                              In the Annex, the following footnote concerning the entry for Bulgaria is added:

                                          ‘(7)

                                          On the basis of the preliminary analysis and the updated information, the 11 % target is based on a positive development of renewable energies and on favourable climate conditions. The possibility of reaching this indicative target is highly dependent upon the total annual rainfall, timing of rainfall during the year and inflow as well as other climatic factors heavily affecting the level of hydropower production and utilization of solar and wind energy. Furthermore, the RES utilization is limited by the relevant environmental and related national legislation corresponding to the respective EU legislation.’.