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31977L0094

Council Directive 77/94/EEC of 21 December 1976 on the approximation of the laws of the Member States relating to foodstuffs for particular nutritional uses

Official Journal L 026 , 31/01/1977 P. 0055 - 0058 Greek special edition: Chapter 03 Volume 17 P. 0038  Spanish special edition: Chapter 13 Volume 7 P. 0003  Portuguese special edition Chapter 13 Volume 7 P. 0003

++++COUNCIL DIRECTIVE  OF 21 DECEMBER 1976  ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO FOODSTUFFS FOR PARTICULAR NUTRITIONAL USES   ( 77/94/EEC )  THE COUNCIL OF THE EUROPEAN COMMUNITIES ,  HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY , AND IN PARTICULAR ARTICLE 100 THEREOF ,  HAVING REGARD TO THE PROPOSAL FROM THE COMMISSION ,  HAVING REGARD TO THE OPINION OF THE EUROPEAN PARLIAMENT ( 1 ) ,  HAVING REGARD TO THE OPINION OF THE ECONOMIC AND SOCIAL COMMITTEE ( 2 ) ,  WHEREAS THE DIFFERENCES BETWEEN NATIONAL LAWS RELATING TO FOODSTUFFS FOR PARTICULAR NUTRITIONAL USES IMPEDE THEIR FREE MOVEMENT , MAY CREATE UNEQUAL CONDITIONS OF COMPETITION AND THUS HAVE A DIRECT IMPACT ON THE ESTABLISHMENT AND FUNCTIONING OF THE COMMON MARKET ;  WHEREAS THE APPROXIMATION OF THESE LAWS IS THEREFORE NECESSARY ;  WHEREAS THIS APPROXIMATION PRE-SUPPOSES , IN AN INITIAL STAGE , THE PREPARATION OF A COMMON DEFINITION , THE DETERMINATION OF MEASURES ENABLING THE CONSUMER TO BE PROTECTED AGAINST FRAUD CONCERNING THE NATURE OF THESE PRODUCTS AND THE ADOPTION OF RULES TO BE COMPLIED WITH IN LABELLING THE PRODUCTS IN QUESTION ;  WHEREAS , IN A SUBSEQUENT STAGE , THE COUNCIL WILL HAVE TO ADOPT THE DEFINITIONS AND DETERMINE THE PARTICULAR CHARACTERISTICS APPLICABLE TO CERTAIN GROUPS OF THESE PRODUCTS ;  WHEREAS THE WORD " DIETERIC " ( OR " DIETARY " ) DOES NOT HAVE THE SAME ACCEPTED MEANING IN ALL THE MEMBER STATES ; WHEREAS THE LATTER MUST BE ABLE TO TAKE INTO ACCOUNT THE CUSTOMS EXISTING WHEN THIS DIRECTIVE IS IMPLEMENTED ;  WHEREAS THE PRODUCTS COVERED BY THIS DIRECTIVE ARE FOODSTUFFS THE COMPOSITION AND PREPARATION OF WHICH MUST BE SPECIALLY DESIGNED TO MEET THE PARTICULAR NUTRITIONAL REQUIREMENTS OF THE PERSONS FOR WHOM THEY ARE MAINLY INTENDED ; WHEREAS IT MIGHT BE NECESSARY , THEREFORE , TO PROVIDE FOR DEROGATIONS TO THE GENERAL OR SPECIFIC PROVISIONS APPLICABLE TO FOODSTUFFS IN ORDER TO ARRIVE AT THE SPECIFIC NUTRITIONAL OBJECTIVE ;  WHEREAS THE DETERMINATION OF THE SAMPLING PROCEDURES AND METHODS OF ANALYSIS FOR VERIFYING THE ADDITIVES AND THE COMPOSITION AND MANUFACTURING SPECIFICATIONS OF THE VARIOUS GROUPS OF FOODSTUFFS INTENDED FOR PARTICULAR NUTRITIONAL USES IS AN IMPLEMENTING MEASURE OF A TECHNICAL NATURE ; WHEREAS ITS ADOPTION SHOULD BE ENTRUSTED TO THE COMMISSION IN ORDER TO SIMPLIFY AND EXPEDITE THE PROCEDURE ;  WHEREAS IN ALL THE CASES FOR WHICH THE COUNCIL CONFERS POWERS ON THE COMMISSION FOR IMPLEMENTING RULES LAID DOWN IN THE FIELDS OF FOODSTUFFS INTENDED FOR HUMAN CONSUMPTION , PROVISIONS SHOULD BE MADE FOR A PROCEDURE FOR ESTABLISHING CLOSE COOPERATION BETWEEN THE MEMBER STATES AND THE COMMISSION WITHIN THE STANDING COMMITTEE ON FOODSTUFFS ,  HAS ADOPTED THIS DIRECTIVE :  ARTICLE 1  1 . THIS DIRECTIVE CONCERNS FOODSTUFFS FOR PARTICULAR NUTRITIONAL USES .  2 . ( A ) FOODSTUFFS FOR PARTICULAR NUTRITIONAL USES ARE FOODSTUFFS WHICH , OWING TO THEIR SPECIAL COMPOSITION OR MANUFACTURING PROCESS , ARE CLEARLY DISTINGUISHABLE FROM FOODSTUFFS FOR NORMAL CONSUMPTION , WHICH ARE SUITABLE FOR THEIR CLAIMED NUTRITIONAL PURPOSES AND WHICH ARE MARKETED IN SUCH A WAY AS TO INDICATE SUCH SUITABILITY .   ( B ) A PARTICULAR NUTRITIONAL USE MUST FULFIL THE PARTICULAR NUTRITIONAL REQUIREMENTS :   ( I ) OF CERTAIN CATEGORIES OF PERSONS WHOSE DIGESTIVE PROCESSES OR METABOLISM ARE DISTURBED , OR   ( II ) OF CERTAIN CATEGORIES OF PERSONS WHO ARE IN A SPECIAL PHYSIOLOGICAL CONDITION AND WHO ARE THEREFORE ABLE TO OBTAIN SPECIAL BENEFIT FROM A CONTROLLED CONSUMPTION OF CERTAIN SUBSTANCES IN FOODSTUFFS , OR   ( III ) OF INFANTS OR YOUNG CHILDREN IN GOOD HEALTH .  3 . THE COUNCIL , IN ACCORDANCE WITH THE PROCEDURE LAID DOWN IN ARTICLE 100 OF THE TREATY , SHALL , BY MEANS OF DIRECTIVES , ADOPT THE SPECIFIC PROVISIONS APPLICABLE TO CERTAIN GROUPS OF PRODUCTS DEFINED IN THIS ARTICLE ( SPECIFIC DIRECTIVES ) .  ARTICLE 2  1 . THE NATURE OR COMPOSITION OF THE PRODUCTS REFERRED TO IN ARTICLE 1 MUST BE SUCH THAT THE PRODUCTS ARE APPROPRIATE FOR THE PARTICULAR NUTRITIONAL USE INTENDED .  2 . THE PRODUCTS REFERRED TO IN ARTICLE 1 MAY BE CHARACTERIZED AS " DIETETIC " OR " DIETARY " .  HOWEVER , MEMBER STATES MAY RESTRICT THE USE OF THESE ADJECTIVES TO THE PRODUCTS DEFINED IN ARTICLE 1 ( 2 )  ( B ) ( I ) OR ( B ) ( I ) AND ( II ) .  3 . IN TRADE IN FOODSTUFFS FOR NORMAL CONSUMPTION AND IN ADVERTISEMENTS FOR THEM , MEMBER STATES SHALL PROHIBIT :   ( A ) THE USE OF THE ADJECTIVES " DIETETIC " OR  " DIETARY " , EITHER ALONE OR IN CONJUCTION WITH OTHER WORDS , TO DESIGNATE THESE FOODSTUFFS ;   ( B ) ALL OTHER MARKINGS OR ANY PRESENTATION LIKELY TO GIVE THE IMPRESSION THAT ONE OF THE PRODUCTS REFERRED TO IN ARTICLE 1 IS INVOLVED .  4 . HOWEVER , IN ACCORDANCE WITH THE SPECIFIC DIRECTIVES OR , IN THEIR ABSENCE , IN ACCORDANCE WITH NATIONAL PROVISIONS , IT SHALL BE POSSIBLE , FOR FOODSTUFFS FOR NORMAL CONSUMPTION WHICH ARE SUITABLE FOR A PARTICULAR NUTRITIONAL USE , TO INDICATE SUCH SUITABILITY .  THE AFORESAID PROVISIONS MAY LAY DOWN THE ARRANGEMENTS FOR INDICATING THIS SUITABILITY .  ARTICLE 3  THE PRODUCTS REFERRED TO IN ARTICLE 1 MUST ALSO COMPLY WITH ANY MANDATORY PROVISIONS APPLICABLE TO FOODSTUFFS FOR NORMAL CONSUMPTION , SAVE AS REGARDS CHANGES MADE TO THEM TO ENSURE THEIR CONFORMITY WITH THE DEFINITIONS GIVEN IN ARTICLE 1 AND PROVIDED THAT THESE CHANGES ARE PERMITTED UNDERTHE SPECIFIC DIRECTIVE OR , IN THEIR ABSENCE , UNDER NATIONAL PROVISIONS .  ARTICLE 4  1 . THE LABEL OR METHOD OF LABELLING , THE PRESENTATION AND ADVERTISING OF THE PRODUCTS REFERRED TO IN ARTICLE 1 MUST NOT ATTRIBUTE PROPERTIES FOR THE PREVENTION , TREATMENT OR CURE OF HUMAN DISEASE TO SUCH PRODUCTS OR IMPLY SUCH PROPERTIES .  THE SPECIFIC DIRECTIVES OR , IN THEIR ABSENCE , NATIONAL PROVISIONS MAY PROVIDE FOR DEROGATIONS FROM THE FIRST SUBPARAGRAPH IN EXCEPTIONAL AND CLEARLY DEFINED CASES .  2 . THE SPECIFIC DIRECTIVES OR , IN THEIR ABSENCE , NATIONAL PROVISIONS SHALL LAY DOWN THE CONDITIONS UNDER WHICH ANY REFERENCE MAY BE MADE IN LABELLING , PRESENTATION AND ADVERTISING TO A DIET OR TO A CATEGORY OF PERSONS FOR WHICH A PRODUCT REFERRED TO IN ARTICLE 1 IS INTENDED .  3 . PARAGRAPH 1 SHALL NOT PREVENT THE DISSEMINATION OF ANY USEFUL INFORMATION OR RECOMMENDATIONS EXCLUSIVELY INTENDED FOR PERSONS HAVING QUALIFICATIONS IN MEDICINE , NUTRITION OR PHARMACY .  ARTICLE 5  1 . THE PROVISIONS CONCERNING THE LABELLING OF FOODSTUFFS IN GENERAL OR OF CERTAIN SPECIFIED FOODSTUFFS FOR NORMAL CONSUMPTION SHALL APPLY TO THE PRODUCTS REFERRED TO IN ARTICLE 1 .  2 . THE FOLLOWING PARTICULARS SHALL ALSO APPEAR ON THE LABELS OF THE PRODUCTS REFERRED TO IN ARTICLE 1 :   ( A ) THE PARTICULAR NUTRITIONAL CHARACTERISTICS ACCOMPANYING THE DESCRIPTION ; HOWEVER , IN THE CASE OF THE PRODUCTS REFERRED TO IN ARTICLE 1 ( 2 ) ( B ) ( III ) , THIS REFERENCE MAY BE REPLACED BY A REFERENCE TO THE PURPOSE FOR WHICH THEY ARE INTENDED ;   ( B ) THE PARTICULAR ELEMENTS OF THE QUALITATIVE AND QUANTITATIVE COMPOSITION OR THE SPECIAL MANUFACTURING PROCESS WHICH GIVES THE PRODUCT ITS PARTICULAR NUTRITIONAL CHARACTERISTICS ;   ( C ) THE AVAILABLE ENERGY VALUE EXPRESSED IN KJ AND KCAL AND THE CARBOHYDRATE , PROTEIN AND FAT CONTENT PER 100 G OR 100 ML OF THE PRODUCT AS MARKETED AND , WHERE APPROPRIATE , PER SPECIFIED QUANTITY OF THE PRODUCT AS PROPOSED FOR CONSUMPTION .  IF , HOWEVER , THE ENERGY VALUE IS LESS THAN 50 KJ  ( 12 KCAL ) PER 100 G OR 100 ML OF THE PRODUCT AS MARKETED , THESE PARTICULARS MAY BE REPLACED EITHER BY THE WORDS " ENERGY VALUE LESS THAN 50 KJ  ( 12 KCAL ) PER 100 G " OR BY THE WORDS " ENERGY VALUE LESS THAN 50 KJ ( 12 KCAL ) PER 100 ML " ;   ( D ) THE NET QUANTITY ;   ( E ) WHERE APPROPRIATE , THE PARTICULARS REQUIRED UNDER THE SPECIFIC DIRECTIVES OR , IN THEIR ABSENCE , UNDER NATIONAL PROVISIONS .  3 . THIS DIRECTIVE SHALL NOT AFFECT THE NATIONAL LAWS WHICH PROVIDE FOR :   - A LIST OF INGREDIENTS , INCLUDING ADDITIVES ,   - DATE-MARKING .  ARTICLE 6  1 . THE PRODUCTS REFERRED TO IN ARTICLE 1 SHALL ONLY BE ALLOWED ON THE RETAIL MARKET IN PREPACKAGED FORM , AND THE PACKAGING SHALL COMPLETELY COVER THE PRODUCTS .  2 . MEMBER STATES MAY , HOWEVER , PERMIT DEROGATIONS FROM THIS PROVISION FOR PURPOSES OF THE RETAIL TRADE PROVIDED THAT THE PRODUCT IS ACCOMPANIED BY THE PARTICULARS PROVIDED FOR IN ARTICLE 5 AT THE TIME WHEN IT IS PUT ON SALE .  ARTICLE 7  1 . WITHOUT PREJUDICE TO ARTICLES 3 , 5 AND 12 , MEMBER STATES SHALL ADOPT ALL THE MEASURES NECESSARY TO ENSURE THAT TRADE IN THE PRODUCTS REFERRED TO IN ARTICLE 1 WHICH COMPLY WITH THE DEFINITIONS AND RULES LAID DOWN IN THIS DIRECTIVE OR IN THE SPECIFIC DIRECTIVES CANNOT BE IMPEDED BY THE APPLICATION OF NON-HARMONIZED NATIONAL PROVISIONS GOVERNING THE COMPOSITION , MANUFACTURING SPECIFICATIONS , PACKAGING OR LABELLING OF THESE PRODUCTS IN PARTICULAR OR OF FOODSTUFFS IN GENERAL .  2 . PARAGRAPH 1 SHALL NOT APPLY IN RESPECT OF NON-HARMONIZED PROVISIONS JUSTIFIED ON GROUNDS OF :   - PROTECTION OF PUBLIC HEALTH ,   - PREVENTION OF FRAUD , UNLESS SUCH PROVISIONS ARE LIABLE TO IMPEDE THE APPLICATION OF THE DEFINITIONS AND RULES LAID DOWN BY THIS DIRECTIVE ,   - PROTECTION OF INDUSTRIAL AND COMMERCIAL PROPERTY , INDICATIONS OF SOURCES , DESIGNATIONS OF ORIGIN OR PREVENTION OF UNFAIR COMPETITION .  ARTICLE 8  1 . THE COUNCIL , ACTING UNANIMOUSLY ON A PROPOSAL FROM THE COMMISSION , SHALL LAY DOWN , AS FAR AS IS NECESSARY , THE PURITY CRITERIA FOR THE SUBSTANCES FOR PARTICULAR NUTRITIONAL USES AND ADDITIVES THE USE OF WHICH IS AUTHORIZED FOR EACH GROUP OF PRODUCTS REFERRED TO IN ARTICLE 1 .  2 . THE FOLLOWING SHALL BE DETERMINED IN ACCORDANCE WITH THE PROCEDURE LAID DOWN IN ARTICLE 9 :   ( A ) THE SAMPLING PROCEDURES AND METHODS OF ANALYSIS NEEDED TO VERIFY THAT THE PURITY CRITERIA REFERRED TO IN PARAGRAPH 1 ARE SATISFIED ;   ( B ) THE SAMPLING PROCEDURES AND METHODS OF ANALYSIS NEEDED TO VERIFY THE COMPOSITION AND MANUFACTURING SPECIFICATIONS OF VARIOUS GROUPS OF PRODUCTS REFERRED TO IN ARTICLE 1 , INCLUDING THE DEFINITION OF DEFECTS AND DEFECTIVE UNITS .  ARTICLE 9  1 . WHERE THE PROCEDURE LAID DOWN IN THIS ARTICLE IS FOLLOWED , THE MATTER SHALL BE REFERRED TO THE STANDING COMMITTEE ON FOODSTUFFS SET UP BY THE COUNCIL DECISION OF 13 NOVEMBER 1969 ( HEREINAFTER REFERRED TO AS " THE COMMITTEE " ) BY ITS CHAIRMAN , EITHER ON HIS OWN INITIATIVE OR AT THE REQUEST OF A REPRESENTATIVE OF A MEMBER STATE .  2 . THE REPRESENTATIVE OF THE COMMISSION SHALL SUBMIT TO THE COMMITTEE A DRAFT OF THE MEASURES TO BE TAKEN . THE COMMITTEE SHALL GIVE ITS OPINION ON THAT DRAFT WITHIN A TIME LIMIT SET BY THE CHAIRMAN HAVING REGARD TO THE URGENCY OF THE MATTER . OPINIONS SHALL BE DELIVERED BY A MAJORITY OF 41 VOTES , THE VOTES OF THE MEMBER STATES BEING WEIGHTED AS PROVIDED IN ARTICLE 148 ( 2 ) OF THE TREATY . THE CHAIRMAN SHALL NOT VOTE .  3 . ( A ) WHERE THE MEASURES ENVISAGED ARE IN ACCORDANCE WITH THE OPINION OF THE COMMITTEE , THE COMMISSION SHALL ADOPT THEM .   ( B ) WHERE THE MEASURES ENVISAGED ARE NOT IN ACCORDANCE WITH THE OPINION OF THE COMMITTEE , OR IF NO OPINION IS DELIVERED , THE COMMISSION SHALL WITHOUT DELAY SUBMIT TO THE COUNCIL A PROPOSAL ON THE MEASURES TO BE TAKEN . THE COUNCIL SHALL ACT BY A QUALIFIED MAJORITY .   ( C ) IF WITHIN THREE MONTHS OF THE PROPOSAL BEING SUBMITTED TO IT , THE COUNCIL HAS NOT ACTED , THE PROPOSED MEASURES SHALL BE ADOPTED BY THE COMMISSION .  ARTICLE 10  ARTICLE 9 SHALL APPLY FOR 18 MONTHS FROM THE DATE ON WHICH THE MATTER WAS FIRST REFERRED TO THE COMMITTEE UNDER ARTICLE 9 ( 1 ) .  ARTICLE 11  THIS DIRECTIVE SHALL NOT APPLY TO PRODUCTS INTENDED FOR EXPORT OUTSIDE THE COMMUNITY .  ARTICLE 12  WITHIN A PERIOD OF 18 MONTHS FROM NOTIFICATION OF THIS DIRECTIVE , THE MEMBER STATES SHALL , WHERE NECESSARY , AMEND THEIR LAWS TO COMPLY WITH THIS DIRECTIVE AND SHALL FORTHWITH INFORM THE COMMISSION THEREOF . THE LAWS THUS AMENDED SHALL BE APPLIED IN SUCH A WAY AS TO :   - PERMIT , TWO YEARS AFTER NOTIFICATION OF THIS DIRECTIVE , TRADE IN PRODUCTS COMPLYING WITH THIS DIRECTIVE , WITHOUT PREJUDICE TO THE NATIONAL PROVISIONS WHICH SHALL APPLY IN THE ABSENCE OF THE SPECIFIC DIRECTIVES ,   - PROHIBIT , THREE YEARS AFTER NOTIFICATION OF THIS DIRECTIVE , TRADE IN PRODUCTS WHICH DO NOT COMPLY WITH THIS DIRECTIVE .  ARTICLE 13  THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .  DONE AT BRUSSELS , 21 DECEMBER 1976 .  FOR THE COUNCIL  THE PRESIDENT  A . P . L . M . M . VAN DER STEE  ( 1 ) OJ NO C 139 , 28 . 10 . 1969 , P . 39 .  ( 2 ) OJ NO C 10 , 27 . 1 . 1970 , P . 27 .


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31985L0432

Council Directive 85/432/EEC of 16 September 1985 concerning the coordination of provisions laid down by Law, Regulation or Administrative Action in respect of certain activities in the field of pharmacy

Official Journal L 253 , 24/09/1985 P. 0034 - 0036 Finnish special edition: Chapter 6 Volume 2 P. 0111  Spanish special edition: Chapter 06 Volume 3 P. 0025  Swedish special edition: Chapter 6 Volume 2 P. 0111  Portuguese special edition Chapter 06 Volume 3 P. 0025

*****COUNCIL  DIRECTIVE  of 16 September 1985  concerning the coordination of provisions laid down by law, regulation or administrative action in respect of certain activities in the field of pharmacy  (85/432/EEC)  THE COUNCIL OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 49 and 57 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 persons who hold a diploma, certificate or other formal qualification in pharmacy are for that reason specialists in the field of medicinal products and, in principle, must have access in all the Member States to a minimum range of activities in that field; whereas, in defining that minimum range, this Directive does not have the effect of limiting the activities accessible in the Member States to pharmacists, in particular with regard to medical biology analyses, and does not give them any monopoly, since the creation of a monopoly continues to be a matter for the Member States alone;  Whereas, moreover, this Directive does not ensure coordination of all conditions of access to and pursuit of activities in the field of pharmacy; whereas, in particular, the geographical distribution of pharmacies and the monopoly of the supply of medicinal products continue to be matters for the Member States;  Whereas, with a view to achieving mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy, as required by Council Directive 85/433/EEC of 16 September 1985 concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy, including measures to facilitate the effective exercise of the right of establishment relating to certain activities in the field of pharmacy (4), the broad comparability of training courses in the Member States enables coordination in this field to be confined to the requirement that minimum standards be observed, thus leaving the Member States freedom of organization as regards teaching;  Whereas this Directive does not prevent the Member States from requiring supplementary conditions of training for access to activities not included in the coordinated minimum range of activities; whereas for this reason a host Member State which lays down such conditions may subject thereto nationals of Member States who hold one of the diplomas referred to in Article 4 of Directive 85/433/EEC;  Whereas the coordination provided for by this Directive covers professional qualifications; whereas, as regards such qualifications, most Member States do not at present distinguish between professional persons who pursue their activities as employed persons and those who are self-employed; whereas, for this reason, it appears necessary to extend the application of this Directive to employed professional persons;  Whereas further training is being developed in the Member States in certain aspects of pharmacy which is intended to extend certain areas of knowledge acquired during the training of pharmacists; whereas, therefore, with a view to mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy specialities and in order to put all members of the profession who are nationals of the Member States on an equal footing within the Community, some coordination of the requirements for training in pharmacy specialities is necessary where there are specialized forms of training common to several Member States which can entitle a person to use a specialist title, without such training being a condition of access to the activities included in the coordinated minimum range of activities; whereas such coordination does not seem possible at this stage, but constitutes an objective to be attained as soon as possible together with the relevant mutual recognition,  HAS ADOPTED THIS DIRECTIVE:  Article 1  1. Member States shall ensure that holders of a diploma, certificate or other university or equivalent qualification in pharmacy which meets the conditions laid down in Article 2 shall be entitled at least to access to the activities mentioned in paragraph 2 and to pursue such activities subject, where appropriate, to the requirement of additional professional experience.  2. The activities referred to in paragraph 1 are:  - the preparation of the pharmaceutical form of medicinal products,  - the manufacture and testing of medicinal products,  - the testing of medicinal products in a laboratory for the of medicinal of medicinal products,  - the storage, preservation and distribution of medicinal products at the wholesale stage,  - the preparation, testing, storage and supply of medicinal products in pharmacies open to the public,  - the preparation, testing, storage and dispensing of medicinal products in hospitals,  - the provisions of information and advice on medicinal products.  3. Where at the time of adoption of this Directive a system of competition based on tests exists in a Member State for the purpose of selecting from among the holders referred to in paragraph 1 those to be appointed to control the new pharmacies to be set up under a national geographical distribution system, that Member State may, by way of derogation from paragraph 1, retain this competition system and may oblige nationals of the Member States holding the diplomas, certificates and other formal qualifications in pharmacy referred to in Article 2 (1) and Article 6 of Directive 85/433/EEC to take part in such a competition.  Article 2  Member States shall subordinate the award of the diplomas, certificates and other formal qualifications referred to in Article 1 to the following minimum conditions:  1. Training leading to the award of the diploma, certificate or other formal qualification shall ensure:  (a) adequate knowledge of medicines and the substances used in the manufacture of medicines;  (b) adequate knowledge of pharmaceutical technology and the physical, chemical, biological and microbiological testing of medicinal products;  (c) adequate knowledge of the metabolism and the effects of medicinal products and of the action of toxic substances, and of the use of medicinal products;  (d) adequate knowledge to evaluate scientific data concerning medicines in order to be able to supply appropriate information on the basis of this knowledge;  (e) adequate knowledge of the legal and other requirements associated with the practice of pharmacy.  2. In order to be accepted for such training, the candidate must have a diploma or a certificate which entitles him to be admitted for the course of study concerned to the universities of a Member State or to higher education institutions recognized as having equivalent status.  3. The diploma, certificate or other formal qualification shall testify to the completion of a course of training covering a period of at least five years and comprising:  - at least four years of full-time theoretical and practical training in a university, in a higher education institution of a level recognized as having equivalent status, or under the supervision of a university,  - at least six months of in-service training in a pharmacy open to the public or in a hospital under the supervision of the pharamaceutical department of that hospital. 4. By way of derogation from point 3:  (a) if at the time of the adoption of this Directive two courses of training coexist in a Member State, one of which lasts five years and the other four years, the diploma, certificate or other formal qualification testifying to the completion of the four-year course of training, shall be considered to fulfil the condition concerning duration referred to in point 3 provided that the diplomas, certificates or other formal qualifications testifying to the completion of the two courses of training are recognized as equivalent by that State;  (b) if, because, there are insufficient places in pharmacies open to the public and in hospitals near training establishments, a Member State is unable to provide six months of in-service training, it may, for a period of five years following the expiry of the time limit laid down in Article 5, make provision for no more than half of that training period to involve activities as a pharmacist in an undertaking which manufactures medicinal products.  5. The course of training referred to in point 3 shall comprise as a minimum theoretical and practical training in the following subjects:  - Plant and animal biology,  - Physics,  - General and inorganic chemistry,  - Organic chemistry,  - Analytical chemistry,  - Pharmaceutical chemistry, including analysis of medicinal products,  - General and applied biochemistry (medical),  - Anatomy and physiology; medical terminology,  - Microbiology,  - Pharmacology and pharmacotherapy,  - Pharmaceutical technology,  - Toxicology,  - Pharmacognosy,  - Legislation and, where appropriate, professional ethics.  The balance between theoretical and practical training shall, in respect of each subject, give sufficient importance to theory to maintain the university character of the training.  Article 3  Not more than three years after the expiry of the time limit laid down in Article 5, the Commission shall submit to the Council appropriate proposals on specializations in pharmacy and in particular hospital pharmacy. The Council shall examine these proposals within one year.  Article 4  This Directive shall also apply to nationals of Member States who, in accordance with Council Regulation (EEC) No 1612/68 of 15 October 1968 on freedom of movement for workers within the Community (1), are pursuing or will pursue, as employed persons, one of the activities referred to in Article 1 of Directive 85/433/EEC.  Article 5  1. Member States shall take the measures necessary to comply with this Directive before 1 October 1987. They shall forthwith inform the Commission thereof.  2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.  Article 6  Where a Member State encounters major difficulties in certain fields when applying this Directive, the Commission shall examine these difficulties in conjunction with that State and shall request the opinion of the Pharmaceutical Committee set up by Council Decision 75/320/EEC (2).  Where necessary, the Commission shall submit appropriate proposals to the Council.  Article 7  This Directive is addressed to the Member States.  Done at Luxembourg, 16 September 1985.  For the Council  The President  M. FISCHBACH  (1) OJ No C 35, 18. 2. 1981, p. 3.  (2) OJ No C 277, 17. 10. 1983, p. 160.  (3) OJ No C 230, 10. 9. 1981, p. 10.  (4) See page 37 of this Official Journal.  (1) OJ No L 257, 19. 10. 1968, p. 2.  (2) OJ No L 147, 9. 6. 1975, p. 23.


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31976L0432

Council Directive 76/432/EEC of 6 April 1976 on the approximation of the laws of the Member States relating to the braking devices of wheeled agricultural or forestry tractors

Official Journal L 122 , 08/05/1976 P. 0001 - 0014 Finnish special edition: Chapter 13 Volume 5 P. 0003  Greek special edition: Chapter 13 Volume 3 P. 0206  Swedish special edition: Chapter 13 Volume 5 P. 0003  Spanish special edition: Chapter 13 Volume 5 P. 0005  Portuguese special edition Chapter 13 Volume 5 P. 0005

COUNCIL DIRECTIVE  of 6 April 1976  on the approximation of the laws of the Member States relating to the braking devices of wheeled agricultural or forestry tractors  (76/432/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission,  Having regard to the opinion of the European Parliament (1),  Having regard to the opinion of the Economic and Social Committee (2),  Whereas the technical requirements which tractors must satisfy pursuant to national laws relate inter alia to their braking devices;  Whereas those requirements differ from one Member State to another ; whereas it is therefore necessary that all Member States adopt the same requirements either in addition to or instead of their existing rules, in order, in particular, to allow the EEC type-approval procedure, which was the subject of Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors (3), to be applied in respect of each type of tractor;  Whereas the harmonized requirements are intended principally to improve safety on the road and at work throughout the whole Community;  Whereas the approximation of national laws relating to tractors involves the mutual recognition by Member States of the inspections carried out by each of them on the basis of common requirements ; whereas, for such a system to function successfully, these requirements must be applied by all Member States with effect from the same date,  HAS ADOPTED THIS DIRECTIVE:    Article 1 1. "Agricultural or forestry tractor" means any motor vehicle, fitted with wheels or caterpillar tracks, and having at least two axles, the main function of which lies in its tractive power and which is specially designed to tow, push, carry or power certain tools, machinery or trailers intended for agricultural or forestry use. It may be equipped to carry a load and passengers.  2. This Directive shall apply only to the tractors defined in the preceding paragraph which are fitted with pneumatic tyres and which have two axles and a maximum design speed of between 6 and 25 km/h.  (1)OJ No C 5, 8.1.1975, p. 54. (2)OJ No C 62, 15.3.1975, p. 29. (3)OJ No L 84, 28.3.1974, p. 10.    Article 2 No Member State may refuse to grant EEC type-approval or national type-approval of a tractor on grounds relating to its braking devices if that tractor is fitted with the devices specified in Annexes I to IV and if these devices satisfy the requirements set out therein.   Article 3 No Member State may refuse the registration or prohibit the sale, entry into service or use of tractors on grounds relating to their braking devices if these tractors are fitted with the devices specified in Annexes I to IV and if these devices satisfy the requirements set out therein.   Article 4 A Member State which has granted type-approval of a tractor shall take the necessary measures to ensure that it is informed of any modification to a component or characteristic mentioned in 1.1 of Annex I. The competent authorities of that Member State shall decide whether fresh tests should be carried out on the modified type of tractor and a fresh report drawn up. If such tests reveal failure to comply with the requirements of this Directive, the modification shall not be approved.   Article 5 The amendments necessary for adapting the requirements of the Annexes to take account of technical progress shall be adopted in accordance with the procedure laid down in Article 13 of Council Directive 74/150/EEC.   Article 6 1. Member States shall adopt and publish the provisions necessary to comply with this Directive by 1 January 1977 and shall forthwith inform the Commission thereof.  They shall implement these provisions with effect from 1 October 1977.  2. After notification of this Directive, Member States shall take steps to inform the Commission, in sufficient time for it to make comments, of any draft laws, regulations or administrative provisions which they intend to adopt in the field covered by the Directive.   Article 7 This Directive is addressed to the Member States.     Done at Luxembourg, 6 April 1976.  For the Council  The President  G. THORN     ANNEX I DEFINITIONS, APPLICATION FOR EEC TYPE-APPROVAL, EEC TYPE-APPROVAL, CONSTRUCTION AND FITTING REQUIREMENTS    1. DEFINITIONS      1.1. Type of tractor with respect to the braking devices  "Type of tractor with respect to the braking devices" means tractors which do not differ in such essential respects as:        1.1.1. unladen weight, as defined in 1.18,               1.1.2. maximum weight, as defined in 1.16,               1.1.3. distribution of the weight between the axles,               1.1.4. technically permissible maximum weight on each axle,               1.1.5. maximum design speed,               1.1.6. different type of braking device (with particular reference to the presence or otherwise of devices for braking a trailer),               1.1.7. number and arrangement of the braked axles,               1.1.8. type of engine,               1.1.9. overall transmission ratio corresponding to maximum speed,               1.1.10. tyre dimensions (braked axles).                          1.2. Braking device  "Braking device" means a combination of parts whose function is progressively to reduce the speed of a moving tractor or to bring it to a halt, or to keep it stationary if already halted. These functions are specified in 4.1.2. A device shall consist of the control, the transmission and the brakes themselves.           1.3. Graduated braking  "Graduated braking" means braking during which, on either the application or release of the brakes, within the normal range of operation of the device:        1.3.1. the driver can at any time increase or reduce the braking force through action on the control,               1.3.2. the braking force acts in the same direction as the action on the control (monotonic function),               1.3.3. it is easy to make a sufficiently fine adjustment to the braking force.                          1.4. Control  "Control" means the part actuated directly by the driver to supply to the transmission the energy required for braking or controlling it. This energy may be the muscular energy of the driver, or energy from another source controlled by the driver, or a combination of these various kinds of energy.           1.5. Transmission  "Transmission" means the combination of components situated between the control and the brake and connecting the two operationally. The transmission  may be mechanical, hydraulic, pneumatic, electrical, or mixed. Where the braking power is derived from or assisted by a source of energy independent of the driver but controlled by him, the reserve of energy in the device shall likewise be regarded as part of the transmission.           1.6. Brake  "Brake" means the component in which the forces opposing the movement of the tractor develop. It may be a friction brake (when the forces are generated by the friction between the two parts of the tractor moving relatively to one another), an electrical brake (when the forces are generated by electro-magnetic action between two parts of the tractor moving relatively to but not in contact with one another), a fluid brake (when the forces are generated by the action of a fluid situated between two parts of the tractor moving relatively to one another), or an engine brake (when the forces are derived from a controlled increase in the braking action of the engine transmitted to the wheels). A device which mechanically locks the tractor's transmission but which cannot be used when the tractor is in motion shall be regarded as a parking brake.           1.7. Different types of braking devices  "Different types of braking devices" means equipment which differs in such essential respects as:        1.7.1. the characteristics of one or more components, for example the material, shape or size,               1.7.2. the arrangement of the components.                          1.8. Braking system component  "Braking system component" means one of the individual parts which, when assembled, constitute the braking device.           1.9. Continuous braking  "Continuous braking" means the braking of combinations of vehicles through an installation having the following characteristics:        1.9.1. a single control which the driver actuates progressively, by a single movement, from his driving seat,               1.9.2. the energy used for braking the vehicles constituting the vehicle combination is supplied from the same source (which may be the muscular energy of the driver),               1.9.3. the braking installation ensures simultaneous or suitably phased braking of each of the constituent vehicles of the combination, whatever their relative positions.                          1.10. Semi-continuous braking  "Semi-continuous braking" means the braking of combinations of vehicles through an installation having the following characteristics:        1.10.1. a single control which the driver can actuate progressively, by a single movement, from his driving seat,               1.10.2. the energy used for braking the vehicles constituting the vehicle combination is supplied from several different sources (one of which may be the muscular energy of the driver),               1.10.3. the braking installation ensures simultaneous or suitably phased braking of each of the constituent vehicles of the combination, whatever their relative positions.                           1.11. Independent power-operated braking  "Independent power-operated braking" means the braking of combinations of vehicles by means of devices having the following characteristics:        1.11.1. a tractor brake control which is independent of the towed vehicle brake control ; the latter being in all cases mounted on the tractor in such a way as to be easily actuated by the driver from his driving seat,               1.11.2. the muscular energy of the driver is not the energy used for braking the towed vehicles.                          1.12. Independent braking  "Independent braking" means the braking of combinations of vehicles by means of devices having the following characteristics:        1.12.1. a tractor brake control which is independent of the trailer brake control, the latter being in all cases mounted on the tractor in such a way as to be easily actuated by the driver from his driving seat,               1.12.2. the muscular energy of the driver is the energy used for braking the towed vehicles.                          1.13. Automatic braking  "Automatic braking" means braking of the towed vehicle or vehicles occurring automatically in the event of separation of components of the combination of coupled vehicles, including such separation through coupling breakage, without the braking effectiveness of the remainder of the combination being substantially reduced.           1.14. Inertia braking  "Inertia braking" means braking by utilizing the forces generated by the trailer closing up on the tractor.           1.15. Laden tractor  "Laden tractor" means, except where otherwise stated, a tractor laden to its "maximum weight".           1.16. Maximum weight  "Maximum weight" means the maximum technically permissible weight stated by the manufacturer (this weight may be higher than the "authorized maximum weight").           1.17. Unladen tractor  "Unladen tractor" means the tractor in running order, with full tanks and radiators, with a driver of a mass of 75 kg, but without passengers, optional accessories or load.           1.18. Unladen weight  "Unladen weight" means the weight of the unladen tractor.       2. APPLICATION FOR EEC TYPE-APPROVAL      2.1. An application for EEC type-approval for a type of tractor with respect to the braking devices shall be submitted by the manufacturer or by his authorized representative.            2.2. It shall be accompanied by the following documents in triplicate:        2.2.1. a description of the type of tractor as regards the points mentioned in 1.1.1 to 1.1.10. The numbers and/or symbols given by the manufacturer or his authorized representative to the type of tractor must be supplied,               2.2.2. a list of parts, each properly identified, which make up the braking device,               2.2.3. a diagram of the braking device showing the position of each of the parts on the tractor, in order to enable the various components to be located and identified.                          2.3. The following must also be provided:        2.3.1. a tractor, representative of the type of tractor to be approved,               2.3.2. such drawings as may be requested of maximum A4 size (210 × 297 mm), or folded to this size and drawn to the appropriate scale.                                 3. EEC TYPE-APPROVAL  The form as illustrated in Annex V shall be completed and attached to the EEC type-approval certificate.       4. CONSTRUCTION AND FITTING REQUIREMENTS    4.1. General      4.1.1. Braking device        4.1.1.1. The braking device must be so designed, constructed and installed as to enable the tractor in normal use to comply with the undermentioned requirements, despite any vibration to which it may be subjected.               4.1.1.2. In particular, the braking device must be so designed, constructed and installed as to resist corrosion and the effects of ageing during service, which could lead to a sudden loss of braking efficiency.                          4.1.2. Functions of the braking device  The braking device defined in 1.2 must meet the following conditions:      4.1.2.1. Service brakes        4.1.2.1.1. The service brake must enable the motion of the tractor to be controlled and the tractor to be stopped safely, quickly and efficiently, at any design speed and with the authorized load on both up and down gradients. It must be possible to regulate its action. These conditions are deemed to be fulfilled if the requirements of Annex II are satisfied.  The driver must be able to apply the service brake from his seat and retain control of the steering device on the tractor with at least one hand. The service brake of the tractor may comprise right and left hand devices. It must be possible to connect them up so that they can be actuated in a single operation, and possible to disconnect them again.  Each device, right or left hand, must have a system of adjustment, which may be either manual or automatic, enabling the balance of the brakes to be easily restored.           4.1.2.2. Parking brakes      4.1.2.2.1. The parking brake must enable the tractor to be held stationary on an up or down gradient even in the absence of the driver, the working parts being then  held in the locked position by a purely mechanical device. This may be achieved by means of a brake acting on the transmission. The driver must be able to apply the parking brake from his seat ; a repeated action to obtain the required performance is permitted.                 4.2. Characteristics of braking devices      4.2.1. The set of braking devices with which a tractor is equipped must satisfy the requirements laid down for the service and parking brakes.           4.2.2. The service and parking brake devices may have common components, provided that they fulfil the following conditions:        4.2.2.1. there must be at least two controls, independent of each other and readily accessible to the driver from the driving seat ; it must be possible for this requirement to be met even when the driver is wearing a safety belt,               4.2.2.2. in the event of a breakage of any component of the braking device other than the brakes (as defined in 1.6) or of any other failure of the service braking device (malfunction, partial or total exhaustion of an energy reserve), it must be possible to slow the tractor to a halt with a deceleration equal to at least 50 % of the value laid down in 2.1.1 of Annex II.  These conditions shall be fulfilled when residual braking is achieved on wheels located on both sides of the median longitudinal plane (without the tractor deviating from its course).  For the purposes of this section, the lever and cam assemblies, or similar assemblies, by means of which the brakes are applied, shall not be regarded as liable to failure.           4.2.3. Where use is made of energy other than the muscular energy of the driver, there need not be more than one source of such energy (e.g. hydraulic pump, air compressor, etc.) provided the requirements of 4.2.2 are fulfilled.           4.2.4. The service braking device must act on both wheels of at least one axle.           4.2.5. The action of the service braking device must be distributed between the wheels of the same axle symmetrically in relation to the median longitudinal plane of the tractor.           4.2.6. The service braking device and the parking braking device must act on braking surfaces permanently connected to the wheels through components of adequate strength. It must not be possible to uncouple a braking surface from the wheels.  When one axle is subject to braking, the differential must not be mounted between the service brake and the wheels of that axle ; when two axles are subject to braking, the differential may be mounted between the service brake and the wheels on one of the two axles.           4.2.7. Wear on the brakes must be easily compensated for by means of a system of manual or automatic adjustment. In addition, the control and the components of the transmission and the brakes must possess a reserve of travel such that, when the brakes become heated or when the brake linings have reached a certain degree of wear, effective braking is ensured without an immediate adjustment being necessary.           4.2.8. In hydraulic braking devices, the filling ports of the fluid reservoirs must be readily accessible ; in addition, the containers of reserve fluid must be so made that the level of the reserve fluid can be easily checked without the containers having to be opened.           4.2.9. Every tractor fitted with a brake activated from an energy reservoir must, where the prescribed braking performance is impossible without the use of stored energy, be fitted with a warning device, in addition to the pressure gauge, giving a signal which can be seen or heard when the energy, in any part of the  installation up to the control valve, falls to 65 % or less of its normal value. This device must be directly and permanently connected to the circuit.           4.2.10. Without prejudice to the requirements of 4.1.2.1, where the use of an auxiliary energy source is essential for the operation of a braking device, the energy reserve must be such as to ensure that, should the engine stop, the braking performance remains sufficient to bring the tractor to a halt under the prescribed conditions.           4.2.11. Any auxiliary equipment shall draw its energy only in such a way that its operation, even in the event of damage to the energy source, cannot cause the reserves of energy feeding the braking devices to fall below the level indicated in 4.2.9.                             ANNEX II BRAKING TESTS AND PERFORMANCE OF BRAKING DEVICES    1. BRAKING TESTS      1.1. General        1.1.1. The performance prescribed for service braking devices shall be based on the mean deceleration calculated over the stopping distance. The stopping distance shall be the distance covered by the tractor from the moment when the driver begins to actuate the control of the device until the moment when the tractor stops.  The performance prescribed for parking braking devices shall be based on the ability to hold the tractor stationary on an up or down gradient.               1.1.2. For the type-approval of any tractor, the braking performance shall be measured during road tests conducted under the following conditions:          1.1.2.1. the tractor's condition as regards weight must be as prescribed for each type of test and be specified in the test report,                   1.1.2.2. during the tests the force applied to the brake control in order to obtain the prescribed performance must not exceed 60 daN on the pedal controls and 40 daN on the hand-operated controls,                   1.1.2.3. the road must have a surface affording good adhesion,                   1.1.2.4. the tests must be performed when there is no wind liable to affect the results,                   1.1.2.5. at the start of the tests the tyres must be cold and at the pressure prescribed for the load actually borne by the wheels when the tractor is stationary,                   1.1.2.6. the prescribed performance must be obtained without locking of the wheels, without deviation of the tractor from its course, and without abnormal vibration.                                  1.1.3. During the tests, the tractor shall be fitted with any parts intended by the manufacturer for the operation of the towed vehicle braking devices as referred to in 1.9, 1.10, 1.11 and 1.12 of Annex I.                          1.2. Type 0 test (ordinary performance test with brakes cold)        1.2.1. General          1.2.1.1. The brakes must be cold at the beginning of the test. A brake is deemed to be cold if any one of the following conditions is met:            1.2.1.1.1. the temperature measured on the disc or on the outside of the drum must be below 100 ºC,                       1.2.1.1.2. in the case of totally enclosed brakes, including oil immersed brakes, the temperature measured on the outside of the housing must be below 50 ºC,                       1.2.1.1.3. the brakes must not have been actuated for one hour.                                          1.2.1.2. During the braking test, an unbraked axle, when capable of being declutched, must not be connected with a braked axle.                    1.2.1.3. The test must be conducted under the following conditions:            1.2.1.3.1. the tractor must be laden to its maximum weight, with an unbraked axle also loaded to its technically permissible maximum weight ; the braked axle wheels must be fitted with the largest tyres intended for that tractor type by the manufacturer. For tractors braking on all wheels, the front axle must be laden to its technically permissible maximum weight,                       1.2.1.3.2. the test must be repeated on an unladen tractor carrying only the driver and if necessary a person responsible for monitoring the results of the test ; the tractor must be fitted with the largest tyres recommended by the manufacturer,                       1.2.1.3.3. the limits prescribed for minimum performance, both for tests with the tractor unladen and for tests with it laden, shall be those laid down in 2.1.1,                       1.2.1.3.4. the road must be level.                                                         1.2.2. The type 0 test must be carried out:          1.2.2.1. at the maximum design speed with the transmission in neutral,                   1.2.2.2. a tolerance of ± 10 % is permitted on the test speed,                   1.2.2.3. the minimum prescribed performance must be attained.                                             1.3. Type I test (fade test)       1.3.1. Laden tractors shall be tested in such a manner that the energy input is equivalent to that recorded in the same period of time with a laden tractor driven at a steady speed of 80 % ± 5 % of that laid down for type 0 tests on a 10 % down gradient for a distance of 1 km, with the transmission in neutral.           1.3.2. At the end of the test, the residual performance of the service braking device shall be measured under the same conditions as for the type 0 test with the transmission in neutral (under different temperature conditions of course).                 2. PERFORMANCE OF BRAKING DEVICES    2.1. Service braking devices      2.1.1. The service brakes of tractors must:        2.1.1.1. under type 0 test conditions achieve a mean deceleration, calculated from the stopping distance, of at least 2 74 m/s2,               2.1.1.2. after the type I test, produce a residual performance not less than 75 % of that prescribed, and not less than 60 % of the value recorded during the type 0 test (with transmission in neutral).                                 2.2. Parking braking devices      2.2.1. The parking braking device must, even if it is combined with one of the other braking devices, be capable of holding a laden tractor stationary on an 18 % up or down gradient.           2.2.2. On tractors to which the coupling of one or more trailers is authorized, the parking braking device of the tractor must be capable of holding the vehicle combination, comprising an unladen tractor and an unbraked trailer of the same weight (not exceeding three metric tons), stationary on a 12 % up or down gradient.           2.2.3. A parking braking device which has to be actuated several times before attaining the prescribed performance is permissible.                            ANNEX III SPRING BRAKES    1. DEFINITION  "Spring brakes" are braking devices for which the energy required for braking is supplied by one or more springs acting as an energy accumulator.       2. SPECIAL REQUIREMENTS      2.1. A spring brake must not be used as a service brake.           2.2. A small variation in any of the pressure limits which may occur in the brake compression chamber feed circuit must not cause a significant variation in the braking force.           2.3. The feed circuit to the spring compression chamber must include an energy reserve which does not supply any other device or equipment. This requirement shall not apply if the springs can be maintained in the compressed state by using two or more independent systems.           2.4. The device must be so designed that it is possible to apply and release the brakes at least three times starting with an initial pressure in the spring compression chamber equal to the maximum design pressure. This requirement must be met when the brakes are adjusted as closely as possible.           2.5. The pressure in the compression chamber below which the springs begin to actuate the brakes, with the latter adjusted as closely as possible, must not be greater than 80 % of the minimum level of the normal available pressure.           2.6. When the pressure in the spring compression chamber falls to the level at which the brake parts begin to move, a warning signal which can be seen or heard must be activated. Provided this requirements is met, the warning device may be that specified in 4.2.9 of Annex I.           2.7. On tractors fitted with spring brakes and authorized to draw trailers with continuous or semi-continuous brakes, automatic application of the spring brakes must cause the trailer brakes to be applied.                  3. RELEASE SYSTEM    3.1. Spring brakes must be so designed that, in the event of failure, it is possible to release them without using their normal control. This may be achieved by the use of an auxiliary device (pneumatic, mechanical, etc.)       3.2. If the operation of the auxiliary device referred to in 3.1 requires the use of a tool or spanner, the tool or spanner must be kept on the tractor.                 ANNEX IV PARKING BRAKING BY MECHANICAL LOCKING OF THE BRAKE CYLINDERS (LOCK ACTUATORS)    1. DEFINITION  "Mechanical locking of the brake cylinders" means a device for ensuring the operation of the parking brake by mechanical wedging of the brake piston rod.  Mechanical locking occurs when the locking chamber is emptied of compressed air ; the mechanical locking device shall be designed in such a way that it can be released when the locking chamber is again subjected to pressure.       2. SPECIAL REQUIREMENTS    2.1. When the pressure in the locking chamber approaches the level corresponding to mechanical locking, an optical or acoustic warning system must be activated.       2.2. In the case of brake actuators fitted with a mechanical locking device, the brake actuator must be capable of being actuated by either of two energy reserves.       2.3. The locked brake cylinder may only be released if it is certain that the brake can be operated again after such release.       2.4. In the event of a failure of the source of energy supplying the locking chamber, an auxiliary unlocking device (mechanical or pneumatic, for instance) using, for example, the air in one of the tyres of the tractor, must be provided.                ANNEX V MODEL >PIC FILE= "T0009147">    >PIC FILE= "T0009148">


Avis juridique important

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31980L0511

Commission Directive 80/511/EEC of 2 May 1980 authorizing, in certain cases, the marketing of compound feedingstuffs in unsealed packages or containers

Official Journal L 126 , 21/05/1980 P. 0014 - 0014 Finnish special edition: Chapter 3 Volume 12 P. 0035  Greek special edition: Chapter 03 Volume 28 P. 0171  Swedish special edition: Chapter 3 Volume 12 P. 0035  Spanish special edition: Chapter 03 Volume 18 P. 0019  Portuguese special edition Chapter 03 Volume 18 P. 0019

COMMISSION DIRECTIVE  of 2 May 1980  authorizing, in certain cases, the marketing of compound feedingstuffs in unsealed packages or containers  (80/511/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 79/373/EEC of 21 April 1979 on the marketing of compound feedingstuffs for animals (1), and in particular Article 4 thereof,  Whereas under the provisions of the abovementioned Directive compound feedingstuffs must generally be marketed in sealed packages or containers ; whereas, however, derogations from this rule can be granted at Community level;  Whereas the laws at present in force in Member States provide certain exemptions from the obligation to market compound feedingstuffs in sealed packages or containers ; whereas, therefore, in order to facilitate implementation of the provisions of Directive 73/373/EEC derogations which appear justified for practical or economic reasons should be granted at Community level;  Whereas, to ensure that the identity and the quality of compound feedingstuffs conform with the labelling provisions in force, it is necessary to distinguish those cases where, by derogation from present provisions, compound feedingstuffs may be marketed in bulk or in unsealed containers from those cases where they may be marketed either in bulk or in unsealed packages or containers;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs,  HAS ADOPTED THIS DIRECTIVE:    Article 1 1. The Member States shall prescribe that compound feedingstuffs may be marketed in bulk or in unsealed packages or containers in case of:    (a) deliveries between producers of compound feedingstuffs;       (b) deliveries from producers of compound feedingstuffs to packaging firms;       (c) compound feedingstuffs obtained by mixing grain or whole fruit;       (d) blocks or licks;       (e) small quantities of compound feedingstuffs not exceeding 50 kilograms in weight which are intended for the final user and are taken directly from a package or container which before opening complied with the provisions of Article 4 (1) of Directive 79/373/EEC.         2. The Member States shall prescribe that compound feedingstuffs may be marketed in bulk or in unsealed containers, but not in unsealed packages, in the case of:    (a) compound feedingstuffs delivered directly from the producer to the final user;       (b) molassed feedingstuffs consisiting of not more than three ingredients;       (c) pelleted feedingstuffs.          Article 2 The Member States shall bring into force the necessary laws, regulations and administrative provisions to enable them to comply with this Directive with effect from 1 January 1981 and shall forthwith inform the Commission thereof.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 2 May 1980.  For the Commission  Finn GUNDELACH  Vice-President  (1)OJ No L 86, 6.4.1979, p. 30.