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32003L0018

Directive 2003/18/EC of the European Parliament and of the Council of 27 March 2003 amending Council Directive 83/477/EEC on the protection of workers from the risks related to exposure to asbestos at work (Text with EEA relevance)

Official Journal L 097 , 15/04/2003 P. 0048 - 0052

Directive 2003/18/EC of the European Parliament and of the Councilof 27 March 2003amending Council Directive 83/477/EEC on the protection of workers from the risks related to exposure to asbestos at work(Text with EEA relevance)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 137(2) thereof,Having regard to the proposal from the Commission(1), drawn up following consultation with social partners and with the Advisory Committee on Safety, Hygiene and Health Protection at Work,Having regard to the opinion of the European Economic and Social Committee(2),Having consulted the Committee of the Regions,Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),Whereas:(1) In its Conclusions of 7 April 1998 on the protection of workers against the risks from exposure to asbestos(4) the Council invited the Commission to bring forward proposals for amending Directive 83/477/EEC(5), considering in particular the merits of refocusing and adapting protective measures for those who are now most at risk, in particular workers who remove asbestos and workers who accidentally come across asbestos at work in the course of servicing and maintenance activities.(2) In those Conclusions, the Commission was also invited to submit proposals to amend Directive 83/477/EEC in the light of the more detailed research on limits for exposure to chrysotile and the methods for measuring airborne asbestos undertaken on the basis of the method adopted by the World Health Organisation (WHO). Similar steps should be taken regarding substitute fibres.(3) The Economic and Social Committee, in its opinion on asbestos(6), called on the Commission to take new measures to reduce the risks to workers.(4) The ban on the marketing and use of chrysotile asbestos introduced by Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations(7) with effect from 1 January 2005, will contribute to a substantial reduction in asbestos exposure of workers.(5) All workers should be protected against the risks associated with exposure to asbestos and the derogations applicable to the sea and air sectors should therefore be removed.(6) In order to ensure clarity in the definition of the fibres, they should be redefined either in mineralogical terms or with regard to their Chemical Abstract Service (CAS) number.(7) Without prejudice to other Community provisions concerning the marketing and use of asbestos, limiting the activities involving exposure to asbestos should play a very important role in preventing the diseases associated with such exposure.(8) The notification system for activities involving exposure to asbestos should be adapted to new work situations.(9) It is important to eliminate activities which expose workers to asbestos fibres during the extraction of asbestos or the manufacture and processing of asbestos products or the manufacture and processing of products containing intentionally added asbestos fibres, in view of their high and unpredictable level of exposure.(10) Taking account of the latest technical expertise, it is necessary to specify more precisely the sampling methodology used to measure the asbestos level in air and the method of counting fibres.(11) Even though it has not yet been possible to identify the exposure threshold below which asbestos does not involve a cancer risk, the limit value for occupational exposure to asbestos should be reduced.(12) Employers should be required to record, before the start of any asbestos removal project, the presence or presumed presence of asbestos in buildings or installations and communicate this information to others who may be exposed to asbestos as a result of its use, of maintenance or of other activities in or on the building.(13) It should be ensured that demolition or asbestos removal work is carried out by undertakings which are familiar with all the precautions to be taken in order to protect workers.(14) Special training for workers exposed or likely to be exposed to asbestos should be provided in order significantly to contribute to reducing the risks related to such exposure.(15) The content of the exposure register and medical records provided for in Directive 83/477/EEC should be brought into line with the records referred to in Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work (Sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(8).(16) The practical recommendations on the clinical surveillance of exposed workers should be updated in the light of the latest medical expertise, with a view to the early detection of pathologies linked to asbestos.(17) Since the objective of the proposed action, namely improvement in the protection of workers from the risks related to exposure to asbestos at work, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.(18) The amendments contained in this Directive constitute a concrete contribution towards creating the social dimension of the internal market.(19) These amendments are limited to the minimum in order not to impose an unnecessary burden on the creation and development of small and medium-sized enterprises.(20) Directive 83/477/EEC should therefore be amended accordingly,HAVE ADOPTED THIS DIRECTIVE:Article 1Directive 83/477/EEC is hereby amended as follows:1. in Article 1, paragraph 2 shall be deleted;2. Article 2 shall be replaced by the following:"Article 2For the purposes of this Directive, 'asbestos' means the following fibrous silicates:- Asbestos actinolite, CAS No 77536-66-4(9),- Asbestos gruenerite (amosite) CAS No 12172-73-5(10),- Asbestos anthophyllite, CAS No 77536-67-5(11),- Chrysotile, CAS No 12001-29-5(12),- Crocidolite, CAS No 12001-28-4(13),- Asbestos tremolite, CAS No 77536-68-6(14).";3. in Article 3:(a) paragraph 3 shall be replaced by the following:"3. Provided that worker exposure is sporadic and of low intensity, and when it is clear from the results of the risk assessment referred to in paragraph 2 that the exposure limit for asbestos will not be exceeded in the air of the working area, Articles 4, 15 and 16 may be waived where work involves:(a) short, non-continuous maintenance activities in which only non-friable materials are handled,(b) removal without deterioration of non-degraded materials in which the asbestos fibres are firmly linked in a matrix,(c) encapsulation or sealing of asbestos-containing materials which are in good condition,(d) air monitoring and control, and the collection of samples to ascertain whether a specific material contains asbestos."(b) the following paragraph shall be inserted:"3 bis Member States shall, following consultation with social partners in accordance with national law and practice, lay down practical guidelines for the determination of sporadic and low-intensity exposure, as provided for in paragraph 3.";4. Article 4 shall be amended as follows:(a) point 2 shall be replaced by the following:"2. The notification shall be submitted by the employer to the responsible authority of the Member States, before the work commences, in accordance with national laws, regulations and administrative provisions.The notification must include at least a brief description of:(a) the location of the work site,(b) the type and quantities of asbestos used or handled,(c) the activities and processes involved,(d) the number of workers involved,(e) the starting date and duration of the work,(f) measures taken to limit the exposure of workers to asbestos.";(b) point 4 shall be replaced by the following:"4. Each time a change in working conditions is likely to result in a significant increase in exposure to dust from asbestos or materials containing asbestos, a new notification must be submitted.";5. in Article 5 the following paragraph shall be added:"Without prejudice to the application of other Community provisions on marketing and use of asbestos, activities which expose workers to asbestos fibres during the extraction of asbestos or the manufacture and processing of asbestos products or the manufacture and processing of products containing intentionally added asbestos shall be prohibited, with the exception of the treatment and disposal of products resulting from demolition and asbestos removal.";6. Article 6 shall be replaced by the following:"Article 6For all activities referred to in Article 3(1), the exposure of workers to dust arising from asbestos or materials containing asbestos at the place of work must be reduced to a minimum and in any case below the limit value laid down in Article 8, in particular through the following measures:1. the number of workers exposed or likely to be exposed to dust arising from asbestos or materials containing asbestos must be limited to the lowest possible figure;2. work processes must be designed so as not to produce asbestos dust or, if that proves impossible, to avoid the release of asbestos dust into the air;3. all premises and equipment involved in the treatment of asbestos must be capable of being regularly and effectively cleaned and maintained;4. asbestos or dust-generating asbestos-containing material must be stored and transported in suitable sealed packing;5. waste must be collected and removed from the place of work as soon as possible in suitable sealed packing with labels indicating that it contains asbestos. This measure shall not apply to mining activities. Such waste shall then be dealt with in accordance with Council Directive 91/689/EEC of 12 December 1991 on hazardous waste(15).";7. Article 7 shall be replaced by the following:"Article 71. Depending on the results of the initial risk assessment, and in order to ensure compliance with the limit value laid down in Article 8, measurement of asbestos fibres in the air at the workplace shall be carried out regularly.2. Sampling must be representative of the personal exposure of the worker to dust arising from asbestos or materials containing asbestos.3. Sampling shall be carried out after consultation of the workers and/or their representatives in undertakings.4. Sampling shall be carried out by suitably qualified personnel. The samples taken shall be subsequently analysed, in accordance with paragraph 6, in laboratories equipped for fibre counting.5. The duration of sampling must be such that representative exposure can be established for an eight-hour reference period (one shift) by means of measurements or time-weighted calculations.6. Fibre counting shall be carried out wherever possible by PCM (phase-contrast microscope) in accordance with the 1997 WHO (World Health Organisation) recommended method(16) or any other method giving equivalent results.For the purpose of measuring asbestos in the air, as referred to in the first subparagraph, only fibres with a length of more than five micrometres, a breadth of less than three micrometres and a length/breadth ratio greater than 3:1 shall be taken into consideration.";8. Article 8 shall be replaced by the following:"Article 8Employers shall ensure that no worker is exposed to an airborne concentration of asbestos in excess of 0,1 fibres per cm3 as an eight-hour time-weighted average (TWA).";9. in Article 9, paragraph 1 shall be deleted;10. Article 10 shall be amended as follows:(a) in paragraph 1, the first subparagraph shall be replaced by the following:"Where the limit value laid down in Article 8 is exceeded, the reasons for the limit being exceeded must be identified and appropriate measures to remedy the situation must be taken as soon as possible."(b) paragraph 3 shall be replaced by the following:"3. Where exposure cannot be reduced by other means and where compliance with the limit value makes necessary the wearing of individual protective breathing equipment, this may not be permanent and shall be kept to the strict minimum necessary for each worker. During periods of work which require the use of such equipment, provision shall be made for breaks appropriate to the physical and climatological conditions and, where relevant, in consultation with the workers and/or their representatives, in accordance with national laws and practice.";11. the following Article shall be inserted:"Article 10aBefore beginning demolition or maintenance work, employers shall take, if appropriate by obtaining information from the owners of the premises, all necessary steps to identify presumed asbestos-containing materials.If there is any doubt about the presence of asbestos in a material or construction, the applicable provisions of this Directive shall be observed.";12. in Article 11, paragraph 1 shall be replaced by the following:"1. In the case of certain activities such as demolition, removal, repairing and maintenance in respect of which it is foreseeable that the limit value set out in Article 8 will be exceeded despite the use of technical preventive measures for limiting asbestos in air concentrations, the employer shall determine the measures intended to ensure protection of the workers while they are engaged in such activities, in particular the following:(a) workers shall be issued with suitable respiratory and other personal protective equipment, which must be worn; and(b) warning signs shall be put up indicating that it is foreseeable that the limit value laid down in Article 8 will be exceeded; and(c) the spread of dust arising from asbestos or materials containing asbestos outside the premises or site of action shall be prevented.";13. in Article 12(2), the first two subparagraphs shall be replaced by the following:"2. The plan referred to in paragraph 1 must prescribe the measures necessary to ensure the safety and health of workers at the place of work.The plan must in particular specify that:- asbestos and/or asbestos-containing products are to be removed before demolition techniques are applied, except where this would cause a greater risk to workers than if the asbestos and/or asbestos-containing products had been left in place;- the personal protective equipment referred to in Article 11(1)(a) shall be provided, where necessary;- when the asbestos demolition or removal work has been completed, the absence of asbestos exposure risks in the workplace shall be verified in compliance with national legislation and practices.";14. the following Articles shall be inserted:"Article 12a1. Employers shall provide appropriate training for all workers who are, or are likely to be, exposed to asbestos-containing dust. Such training must be provided at regular intervals and at no cost to the workers.2. The content of the training must be easily understandable for workers. It must enable them to acquire the necessary knowledge and skills in terms of prevention and safety, particularly as regards:(a) the properties of asbestos and its effects on health, including the synergistic effect of smoking;(b) the types of products or materials likely to contain asbestos;(c) the operations that could result in asbestos exposure and the importance of preventive controls to minimise exposure;(d) safe work practices, controls and protective equipment;(e) the appropriate role, choice, selection, limitations and proper use of respiratory equipment;(f) emergency procedures;(g) decontamination procedures;(h) waste disposal;(i) medical examination requirements.3. Practical guidelines for the training of asbestos removal workers shall be developed at Community level.Article 12bBefore carrying out asbestos demolition or removal work, firms must provide evidence of their ability in this field. The evidence shall be established in accordance with national laws and/or practice.";15. in Article 14(2), point (b) shall be replaced by the following:"(b) if the results exceed the limit value laid down in Article 8 the workers concerned and their representatives in the undertaking or establishment are informed as quickly as possible of the fact and the reasons for it and the workers and/or their representatives in the undertaking or establishment are consulted on the measures to be taken or, in an emergency, are informed of the measures which have been taken.";16. in Article 15, point (3) shall be replaced by the following:"3. Information and advice must be given to workers regarding any assessment of their health which they may undergo following the end of exposure.The doctor or authority responsible for the medical surveillance of workers may indicate that medical surveillance must continue after the end of exposure for as long as they consider it necessary to safeguard the health of the person concerned.Such continuing surveillance shall be carried out in accordance with the laws and practices of the individual Member States.";17. in Article 16, point 2 shall be replaced by the following:"2. The register referred to in point 1 and the medical records referred to in Article 15(1) shall be kept for at least 40 years following the end of exposure, in accordance with national laws and/or practice.";18. in Article 16 the following point shall be added:"3. The documents referred to in point 2 shall be made available to the responsible authority in cases where the undertaking ceases trading, in accordance with national laws and/or practice.";19. The following Article shall be inserted:"Article 16aMember States shall provide for adequate sanctions to be applicable in the event of infringement of national legislation adopted pursuant to this Directive. These sanctions must be effective, proportionate and dissuasive.";20. Annex I shall be deleted;21. in Annex II, point 3 shall be replaced by the following:"3. Health examination of workers should be carried out in accordance with the principles and practices of occupational medicine. It should include at least the following measures:- keeping records of a worker's medical and occupational history,- a personal interview,- a general clinical examination, with particular reference to the chest,- lung function tests (respiratory flow volumes and rates).The doctor and/or authority responsible for the health surveillance should decide on further examinations, such as sputum cytology tests or a chest X-ray or a tomodensitometry, in the light of the latest occupational health knowledge available."Article 21. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 April 2006. They shall forthwith inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the 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 3This Directive shall enter into force on the date of its publication in the Official Journal of the European Union.Article 4This Directive is addressed to the Member States.Done at Brussels, 27 March 2003.For the European ParliamentP. CoxThe PresidentFor the CouncilM. StratakisThe President(1) OJ C 304 E, 30.10.2001, p. 179 andOJ C 203 E, 27.8.2002, p. 273.(2) OJ C 94, 18.4.2002, p. 40.(3) Opinion of the European Parliament of 11 April 2002 (not yet published in the Official Journal), Council Common Position of 23 September 2002 (OJ C 269 E, 5.11.2002, p. 1) and Decision of the European Parliament of 17 December 2002 (not yet published in the Official Journal). Council Decision of 18 February 2003 (not yet published in the Official Journal).(4) OJ C 142, 7.5.1998, p. 1.(5) OJ L 263, 24.9.1983, p. 25. Directive as last amended by Directive 98/24/EC (OJ L 131, 5.5.1998, p. 11).(6) OJ C 138, 18.5.1999, p. 24.(7) OJ L 262, 27.9.1976, p. 201. Directive as last amended by Commission Directive 2001/91/EC (OJ L 286, 30.10.2001, p. 27).(8) OJ L 196, 26.7.1990, p. 1. Directive as last amended by Directive 1999/38/EC (OJ L 138, 1.6.1999, p. 66).(9) Number in the register of the Chemical Abstract Service (CAS).(10) Number in the register of the Chemical Abstract Service (CAS).(11) Number in the register of the Chemical Abstract Service (CAS).(12) Number in the register of the Chemical Abstract Service (CAS).(13) Number in the register of the Chemical Abstract Service (CAS).(14) Number in the register of the Chemical Abstract Service (CAS).(15) OJ L 377, 31.12.1991, p. 20. Directive as last amended by Directive 94/31/EC (OJ L 168, 2.7.1994, p. 28).(16) Determination of airborne fibre concentrations. A recommended method, by phase-contrast optical microscopy (membrane filter method), WHO, Geneva 1997 (ISBN 92 4 154496 1).


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31980L0778

Council Directive 80/778/EEC of 15 July 1980 relating to the quality of water intended for human consumption

Official Journal L 229 , 30/08/1980 P. 0011 - 0029 Finnish special edition: Chapter 15 Volume 3 P. 0003  Greek special edition: Chapter 15 Volume 1 P. 0255  Swedish special edition: Chapter 15 Volume 3 P. 0003  Spanish special edition: Chapter 15 Volume 2 P. 0174  Portuguese special edition Chapter 15 Volume 2 P. 0174

COUNCIL DIRECTIVE  of 15 July 1980  relating to the quality of water intended for human consumption  (80/778/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 100 and 235 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, in view of the importance for public health of water for human consumption, it is necessary to lay down quality standards with which such water must comply;  Whereas a disparity between provisions already applicable or in the process of being drawn up in the various Member States relating to the quality of water for human consumption may create differences in the conditions of competition and, as a result, directly affect the operation of the common market ; whereas laws in this sphere should therefore be approximated as provided for in Article 100 of the Treaty;  Whereas this approximation of laws should be accompanied by Community action designed to achieve, by more extensive rules concerning water for human consumption, one of the aims of the Community with regard to the improvement of living conditions, the harmonious development of economic activities throughout the Community and a continuous and balanced expansion ; whereas certain specific provisions to this effect should therefore be laid down ; whereas Article 235 of the Treaty should be invoked as the necessary powers have not been provided for by the Treaty;  Whereas the 1973 (3) and 1977 (4) programmes of action of the European Communities on the environment provide for both the setting of standards to apply to toxic chemical substances and to bacteria presenting a health hazard which are present in water intended for human consumption and the definition of physical, chemical and biological parameters corresponding to the different uses of water and, in particular, to water for human consumption;  Whereas special rules are envisaged for natural mineral waters ; whereas, furthermore, it is necessary to exclude from the scope of this Directive medicinal waters and certain waters used in the food industry where such use does not constitute a hazard to public health;  Whereas by Directive 75/440/EEC (5), the Council has already laid down standards for surface water intended for the abstraction of drinking water;  Whereas the values fixed for certain parameters must be equal to or lower than a maximum admissible concentration;  Whereas, in the case of softened water intended for human consumption, the values fixed for certain parameters must be equal to or greater than a required minimum concentration;  Whereas it is desirable that the Member States should take the values adopted as a "guide level";  Whereas, since the preparation of water for human consumption may involve the use of certain substances, rules should be drawn up to govern the use thereof in order to avoid possible harmful effects on public health due to excessive quantities of such substances;  Whereas the Member States should be authorized to make provision, under certain conditions, for derogations from this Directive, in particular to take account of certain special situations;  Whereas, in order to check the values of concentrations for the different parameters, it is necessary to provide that Member States take the steps required to ensure  (1)OJ No C 28, 9.2.1976, p. 27. (2)OJ No C 131, 12.6.1976, p. 13. (3)OJ No C 112, 20.12.1973, p. 1. (4)OJ No C 69, 11.6.1970, p. 1. (5)OJ No L 194, 25.7.1975, p. 34.  regular monitoring of the quality of water intended for human consumption;  Whereas the reference methods of analysis defined in the Annexes to this Directive must be speedily adapted to scientific and technical progress ; whereas, in order to facilitate application of the measures required for this purpose, provision should be made for a procedure establishing close cooperation between the Member States and the Commission within a committee responsible for the adaptation to scientific and technical progress,  HAS ADOPTED THIS DIRECTIVE:    Article 1 This Directive concerns standards for water intended for human consumption.   Article 2 For the purposes of this Directive, water intended for human consumption shall mean all water used for that purpose, either in its original state or after treatment, regardless of origin,    - whether supplied for consumption, or       - whether       - used in a food production undertaking for the manufacture, processing, preservation or marketing of products or substances intended for human consumption and       - affecting the wholesomeness of the foodstuff in its finished form.          Article 3 With regard to water referred to in the second indent of Article 2, Member States shall apply the values for the toxic and microbiological parameters lised in Tables D and E respectively of Annex I and the values for the other parameters which the competent national authorities consider are likely to affect the wholesomeness of the foodstuff in its finished form.   Article 4 1. This Directive shall not apply to:    (a) natural mineral waters recognized or defined as such by the competent national authorities;       (b) medicinal waters recognized as such by the competent national authorities.         2. Member States may not prohibit or impede the marketing of foodstuffs on grounds relating to the quality of the water used where the quality of such water meets the requirements of this Directive unless such marketing constitutes a hazard to public health.   Article 5 This Directive shall apply without prejudice to the specific provisions of other Community regulations.   Article 6 1. Member States shall send the Commission:    - appropriate information as to the industrial sectors in which the competent national authorities consider that the wholesomeness of the finished product, within the meaning of Article 2, is unaffected by the quality of the water used;       - national values for parameters other than the toxic and microbiological parameters referred to in Article 3.         2. The Commission shall examine this information and shall take any measures which may be appropriate. It shall periodically draw up a comprehensive report for the Member States.   Article 7 1. Member States shall fix values applicable to water intended for human consumption for the parameters shown in Annex I.  2. Member States may refrain from fixing, pursuant to the first paragraph, the values of parameters in respect of which no value is shown in Annex I, as long as these values have not been determined by the Council.  3. For the parameters given in Tables A, B, C, D, and E of Annex I:    - the values to be fixed by the Member States must be less than or the same as the values shown in the "Maximum admissible concentration" column;        - in fixing the values, Member States shall take as a basis the values appearing in the "Guide level" column.         4. For the parameters appearing in Table F of Annex I, the values to be fixed by Member States must be not lower than those given in the "Minimum required concentration" column for softened water, of the kind referred to in the first indent of Article 2.  5. In the interpretation of the values shown in Annex I account shall be taken of the observations.  6. Member States shall take the steps necessary to ensure that water intended for human consumption at least meets the requirements specified in Annex I.   Article 8 Member States shall take all the necessary measures to ensure that any substances used in the preparation of water for human consumption do not remain in concentrations higher than the maximum admissible concentration relating to these substances in water made available to the user and, that they do not, either directly or indirectly, constitute a public health hazard.   Article 9 1. Member States may make provision for derogations from this Directive in order to take account of:    (a) situations arising from the nature and structure of the ground in the area from which the supply in question emanates.  Where a Member State decides to make such a derogation, it shall inform the Commission accordingly within two months of its decision stating the reasons for such derogation;       (b) situations arising from exceptional meteorological conditions.  Where a Member State decides to make such a derogation, it shall inform the Commission accordingly within 15 days of its decision stating the reasons for this derogation and its duration.         2. Member States shall report to the Commission only those derogations referred to in paragraph 1 which relate to a daily water supply of at least 1 000 m3 or a population of at least 5 000.  3. In no case shall the derogations made by virtue of this Article relate to toxic or microbiological factors or constitute a public health hazard.   Article 10 1. In the event of emergencies, the competent national authorities may, for a limited period of time and up to a maximum value to be determined by them, allow the maximum admissible concentration shown in Annex I to be exceeded, provided that this does not constitute an unacceptable risk to public health and provided that the supply of water for human consumption cannot be maintained in any other way.  2. Without prejudice to the application of Directive 75/440/EEC, and in particular Article 4 (3) thereof, when, for its supply of drinking water, a Member State is obliged to resort to surface water which does not reach the concentrations required of category A3 water within the meaning of Article 2 of the aformentioned Directive and when it cannot devise suitable treatment to obtain drinking water of the quality laid down by this Directive, it may, for a limited period of time and up to a maximum permissible value which it shall determine, authorize the maximum admissible concentration shown in Annex I to be exceeded provided that this does not constitute an unacceptable risk to public health.  3. Member States which have recourse to the derogations referred to in this Article shall immediately inform the Commission thereof, stating the reasons for and probable duration of such derogations.   Article 11 Member States shall ensure that all necessary measures taken to apply the provisions taken pursuant to this Directive shall in no case have the effect of allowing, directly or indirectly, either any deterioration in the present quality of water intended for human consumption or an increase in the pollution of waters used for the production of drinking water.   Article 12 1. Member States shall take all necessary steps to ensure regular monitoring of the quality of water intended for human consumption.  2. All water intended for human consumption shall be monitored at the point where it is made available to the user in order to check whether it meets the requirements laid down in Annex I.  3. The points of sampling shall be determined by the competent national authorities.   4. For such monitoring, Member States shall conform with Annex II.  5. Member States shall as far as practicable use the reference methods of analysis set out in Annex III.  Laboratories using other methods shall ensure that the results thus obtained are equivalent to or comparable with the results obtained by the methods indicated in Annex III.   Article 13 Such changes as are necessary for adapting the reference methods of analysis set out in Annex III to scientific and technical progress shall be adopted in accordance with the procedure laid down in Article 15.   Article 14  (a) A Committee on the Adaptation to Scientific and Technical Progress, hereinafter called "the Committee", is hereby set up ; it shall consist of representatives of the Member States with a representative of the Commission as chairman.   (b) The Committee shall adopt its own rules of procedure.     Article 15 1. Where the procedure laid down in this Article is to be followed, the matter shall be referred to 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 adopted 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 16 Without prejudice to Article 4 (2), Member States may lay down more stringent provisions than those provided for in this Directive for water intended for human consumption.   Article 17 Member States may adopt special provisions regarding information - both on packaging or labels and in advertising - concerning a water's suitability for the feeding of infants. Such provisions may also concern the properties of the water which determine the use of the said information.  Member States which intend taking such measures shall inform the other Member States and the Commission of them beforehand.   Article 18 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive and its Annexes within two years following its notification. 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 governed by this Directive.   Article 19 The Member States shall take the necessary measures to ensure that the quality of water intended for human consumption complies with this Directive within five years of its notification.   Article 20 Member States may, in exceptional cases and for geographically defined population groups, submit a special request to the Commission for a longer period for complying with Annex I.   This request, for which grounds must be duly put forward, shall set out the difficulties experienced and must propose an action programme with an appropriate timetable to be undertaken for the improvement of the quality of water intended for human consumption.  The Commission shall examine these programmes, including the timetables. In the case of disagreement with the Member State concerned, the Commission shall submit appropriate proposals to the Council.   Article 21 This Directive is addressed to the Member States.     Done at Brussels, 15 July 1980.  For the Council  The President  J. SANTER     ANNEX I LIST OF PARAMETERS    >PIC FILE= "T0013609">    >PIC FILE= "T0013610">    >PIC FILE= "T0013611">    >PIC FILE= "T0013612">    >PIC FILE= "T0013613">    >PIC FILE= "T0013614">    >PIC FILE= "T0013615">    >PIC FILE= "T0013616">     ANNEX II PATTERNS AND FREQUENCY OF STANDARD ANALYSES   >PIC FILE= "T0013617">    >PIC FILE= "T0013618">     ANNEX III REFERENCE METHODS OF ANALYSIS    >PIC FILE= "T0013619">    >PIC FILE= "T0013620">    >PIC FILE= "T0013621">    >PIC FILE= "T0013622">


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31989L0622

Council Directive 89/622/EEC of 13 November 1989 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products

Official Journal L 359 , 08/12/1989 P. 0001 - 0004 Finnish special edition: Chapter 15 Volume 9 P. 0141  Swedish special edition: Chapter 15 Volume 9 P. 0141

COUNCIL DIRECTIVE of 13 November 1989 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products (89/622/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to the proposal from the Commission(1),  In cooperation with the European Parliament(2),  Having regard to the opinion of the Economic and Social Committee(3),  Whereas there are differences between the laws, regulations and administrative provisions of the Member States on the labelling of tobacco products; whereas these differences are likely to constitute barriers to trade and to impede the establishment and  operation of the internal market;  Whereas these possible barriers should be eliminated and whereas, to that end, the marketing and free movement of tobacco products should be made subject to common rules concerning labelling;  Whereas such common rules must take due account of public health protection;  Whereas the European Council meeting held in Milan on 28 and 29 June 1985 stressed the importance of launching a European action programme against cancer;  Whereas the Council and the representatives of the Governments of the Member States, meeting within the Council, in their resolution of 7 July 1986 on a programme of action of the European Communities against cancer(4) set for this programme the  objective of contributing to an improvement of the health and quality of life of citizens within the Community by reducing the number of cancers and whereas they have for this purpose identified a fight against the use of tobacco products as their prime  objective;  Whereas the printing of health warnings on the unit packaging of all tobacco products concerning the risks of use of such products is a vital factor in the protection of public health;  Whereas, for the purpose of improving public health protection, the indication of the tar and nicotine yield on cigarette packets is essential for the health information and education of the general public;  Whereas this Directive contains provisions which will be reviewed on the basis of experience gained and the development of medical knowledge in this area, the objective being to achieve greater protection of individuals;  Whereas, finally, the initiatives set in this Directive will have an even more beneficial effect on public health if they are coupled with health education programmes during the years of compulsory education and with information and public awareness  campaigns,   HAS ADOPTED THIS DIRECTIVE:  Article 1  The objective of this Directive is the harmonization of the laws, regulations and administrative provisions of the Member States concerning the warnings regarding health to appear on the unit packet of tobacco products and the indication of  the tar and nicotine yield to appear on cigarette packets, taking as a base a high level of health protection by reducing the harm done to health by tobacco addiction.  Article 2  For the purposes of this Directive:  (1)tobacco products means products for the purpose of smoking, sniffing, sucking or chewing, inasmuch as they are, even partly, made of tobacco;  (2)tar means the raw anhydrous nicotine-free condensate of smoke;  (3)nicotine means nicotinic alkaloids.  Article 3  1. The tar and nicotine yields that must be indicated on cigarette packets shall be measured on the basis of the ISO 4387 and ISO 3400 methods.  2. The accuracy of the indications on packets shall be verified in accordance with ISO standard 8243.  3. The indications concerned shall be printed on the side of cigarette packets, in the official language or languages of the country of final marketing in clearly legible print on a contrasting background so that at least 4 % of the corresponding  surface is covered. This percentage shall be raised to 6 % for countries with two official languages and to 8 % for countries with three official languages.  4. In January each year the Member States shall forward to the Commission lists of the tar and nicotine contents of the cigarettes sold on their markets. The Commission shall publish this information in the Official Journal of the European Communities.   Article 4  1. All unit packets of tobacco products shall carry, on the most visible surface, the following general warning in the official language or languages of the country of final marketing: Tobacco seriously damages health.  2. With regard to cigarette packets, the other large surface of the packet shall carry, in the official language or languages of the country of final marketing, specific warnings alternating in accordance with the following rule:  -each Member State shall draw up a list of warnings taken exclusively from those listed in the Annex,  -the specific warnings selected shall be printed on the unit packets so as to guarantee the appearance of each warning on an equal quantity of unit packets, with a tolerance of around 5 %.  3. Member States may stipulate that the warnings referred to in paragraphs 1 and 2 be combined with the indication of the authority that is their author.  4. On cigarette packets the warnings provided for in paragraphs 1 and 2 shall cover at least 4 % of each large surface of the unit packet, excluding the indication of the authority provided for in paragraph 3. This percentage shall be increased to 6 %  for countries with two official languages and to 8 % for countries with three official languages.  The required warnings on the two largest surfaces of each cigarette packet:  (a)shall be clear and legible;  (b)shall be printed in bold letters;  (c)shall be printed on a contrasting background;  (d)shall not be printed in a place where they may be damaged when the package is opened;  (e)shall not be printed on the transparent wrapper or any other external wrapping.  5. In the case of tobacco products other than cigarettes, the general warning laid down in paragraph 1 shall be printed in, or irremoveably affixed to, a conspicuous place on a contrasting background and in such a way as to be easilyvisible, clearly  legible and indelible. It shall not in any way be hidden, obscured or interrupted by other written or pictorial matter.  Article 5  Adaptation to technical progress of the provisions of this Directive shall be limited to the measurement and verification methods referred to in Article 3 (1) and (2).  Article 6  With a view to the adaptation to technical progress referred to in Article 5, the Commission shall be assisted by an advisory Committee, composed of representatives of the Member States and chaired by the Commission representative.  Article 7  The Commission representative shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft, within a time limit which the chairman may lay down according to the urgency of the matter,  if necessary by taking a vote.  The opinion shall be recorded in the minutes; in addition, each Member State may ask to have its position recorded in the minutes.  The Commission shall take the utmost account of the opinion delivered by the Committee. It shall inform the Committee of the manner in which its opinion has been taken into account.  Article 8  1. Member States may not, for reasons of labelling, prohibit or restrict the sale of products which comply with this Directive.  2. The provisions of this Directive do not affect the right of the Member States to lay down, in compliance with the Treaty, requirements concerning the import, sale and consumption of tobacco products which they deem necessary in order to protect  public health, provided such requirements do not imply any changes to labelling as laid down in this Directive.  Article 9  1. Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1990.  They shall forthwith inform the Commission thereof and communicate to it the provisions of national law which they adopt in the field governed by this Directive.  The Commission shall publish in the Official Journal of the European Communities the national warning lists drawn up in accordance with the first indent of Article 4 (2).  2. Member States shall bring into force the above laws, regulations and adminsitrative provisions before 31 December 1991.  However,  -until 31 December 1992 cigarettes, and -until 31 December 1993 other tobacco products existing on 31 December 1991 which do not comply with this Directive may still be put on sale.  3. Member States which, after 31 December 1991, amend their warning lists drawn up in accordance with the first indent of Article 4 (2) shall notify the Commission of that amendment eighteen months before its application. The Commission shall publish it  in the Official Journal of the European Communities.  Article 10  This Directive is addressed to the Member States.   Done at Brussels, 13 November 1989.  For the CouncilThe PresidentC. EVIN  (1)OJ No C 48, 20. 2. 1988, p. 8, and OJ No C 62, 11. 3. 1989, p. 12.  (2)OJ No C 12, 16. 1. 1989, p. 106 and OJ No C 291, 20. 11. 1989.  (3)OJ No C 237, 12. 9. 1980, p. 43.  (4)OJ No C 184, 23. 7. 1986, p. 19.


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31971L0354

Council Directive 71/354/EEC of 18 October 1971 on the approximation of the laws of the Member States relating to units of measurement

Official Journal L 243 , 29/10/1971 P. 0029 - 0037 Danish special edition: Series I Chapter 1971(III) P. 0777  English special edition: Series I Chapter 1971(III) P. 0878  Greek special edition: Chapter 13 Volume 1 P. 0235

++++ ( 1 ) OJ N C 78 , 2 . 8 . 1971 , P . 53 .   ( 2 ) OJ N C 93 , 21 . 9 . 1971 , P . 18 .  COUNCIL DIRECTIVE  OF 18 OCTOBER 1971  ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO UNITS OF MEASUREMENT   ( 71/354/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 LAWS WHICH REGULATE THE USE OF UNITS OF MEASUREMENT IN THE MEMBER STATES DIFFER FROM ONE MEMBER STATE TO ANOTHER AND THEREFORE HINDER TRADE ; WHEREAS APPLICATION OF THE RULES RELATING TO MEASURING INSTRUMENTS IS CLOSELY LINKED TO THE USE OF UNITS OF MEASUREMENT IN THE METROLOGICAL SYSTEM ; WHEREAS , IN THESE CIRCUMSTANCES AND HAVING REGARD TO THE INTERDEPENDENCE OF THE RULES CONCERNING UNITS OF MEASUREMENT AND THOSE CONCERNING MEASURING INSTRUMENTS , IT IS NECESSARY TO HARMONISE LAWS , REGULATIONS AND ADMINISTRATIVE PROVISIONS TO ENSURE HARMONIOUS APPLICATION OF EXISTING AND FUTURE COMMUNITY DIRECTIVES RELATING TO MEASURING INSTRUMENTS AND METHODS OF METROLOGICAL CONTROL ;  WHEREAS UNITS OF MEASUREMENT ARE THE SUBJECT OF INTERNATIONAL RESOLUTIONS ADOPTED BY THE GENERAL CONFERENCE OF WEIGHTS AND MEASURES ( CGPM ) SET UP BY THE METRE CONVENTION SIGNED IN PARIS ON 20 MAY 1875 , TO WHICH ALL THE MEMBER STATES ADHERE ; WHEREAS , HOWEVER , UNITS OF MEASUREMENT , AND IN PARTICULAR THEIR NAMES , SYMBOLS AND USE ARE NOT IDENTICAL IN THE MEMBER COUNTRIES ;  HAS ADOPTED THIS DIRECTIVE :  ARTICLE 1  1 . MEMBER STATES SHALL MAKE THE PROVISIONS OF CHAPTER 1 OF THE ANNEX BINDING WITHIN FIVE YEARS OF THE DATE OF ENTRY INTO FORCE OF THIS DIRECTIVE .  2 . MEMBER STATES SHALL , WITH EFFECT FROM 31 DECEMBER 1977 AT THE LATEST , PROHIBIT THE USE OF THE UNITS OF MEASUREMENT LISTED IN CHAPTER III OF THE ANNEX .  3 . THE UNITS OF MEASUREMENT TEMPORARILY RETAINED IN ACCORDANCE WITH THE PROVISIONS OF CHAPTER II OR CHAPTER III OF THE ANNEX MAY NOT BE BROUGHT INTO COMPULSORY USE BY THE MEMBER STATES WHERE THEY ARE NOT AUTHORISED AT THE DATE WHEN THIS DIRECTIVE ENTERS INTO FORCE .  ARTICLE 2  THE OBLIGATIONS ARISING UNDER ARTICLE 1 RELATE TO MEASURING INSTRUMENTS USED , MEASUREMENTS MADE AND INDICATIONS OF QUANTITY EXPRESSED IN UNITS , WHETHER FOR ECONOMIC , PUBLIC HEALTH , PUBLIC SAFETY OR ADMINISTRATIVE PURPOSES .  ARTICLE 3  THIS DIRECTIVE SHALL NOT AFFECT THE USE OF UNITS WHICH IT DOES NOT PRESCRIBE BUT WHICH HAVE BEEN LAID DOWN BY INTERNATIONAL INTERGOVERNMENTAL CONVENTIONS OR AGREEMENTS IN THE FIELD OF AIR AND SEA TRANSPORT AND RAIL TRAFFIC .  ARTICLE 4  1 . MEMBER STATES SHALL PUT INTO FORCE THE LAWS , REGULATIONS AND ADMINISTRATIVE PROVISIONS NEEDED IN ORDER TO COMPLY WITH THIS DIRECTIVE WITHIN EIGHTEEN MONTHS OF ITS NOTIFICATION AND SHALL FORTHWITH INFORM THE COMMISSION THEREOF .  2 . MEMBER STATES SHALL ENSURE THAT THE TEXTS OF THE MAIN PROVISIONS OF NATIONAL LAW WHICH THEY ADOPT IN THE FIELD COVERED BY THIS DIRECTIVE ARE COMMUNICATED TO THE COMMISSION .  ARTICLE 5  THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .  DONE AT LUXEMBOURG , 18 OCTOBER 1971 .  FOR THE COUNCIL  THE PRESIDENT  A . MORO  ANNEX : SEE O.J . N L 243 OF 29 . 10 . 71


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31986L0609

Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes

Official Journal L 358 , 18/12/1986 P. 0001 - 0028 Finnish special edition: Chapter 15 Volume 7 P. 0157  Swedish special edition: Chapter 15 Volume 7 P. 0157

COUNCIL DIRECTIVEof 24  November 1986on the approximation of laws, regulations and administrative provisions of the Member  States regarding the protection of animals used for experimental and other scientific  purposes(86/609/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 (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas there exist between the national laws at present in force for the protection of animals  used for certain experimental purposes disparities which may affect the functioning of the common  market; Whereas, in order to eliminate these disparities, the laws of the Member States should be  harmonized; whereas such harmonization should ensure that the number of animals used for  experimental or other scientific purposes is reduced to a minimum, that such animals are adequately  cared for, that no pain, suffering, distress or lasting harm are inflicted unnecessarily and ensure  that, where unavoidable, these shall be kept to the minimum; Whereas, in particular, unnecessary duplication of experiments should be avoided, (1) OJ N° C 351, 31. 12. 1985, p. 16. (2) OJ N° C 255, 13. 10. 1986, p. 250. (3) OJ N° C 207, 18. 8. 1986, p. 3. HAS ADOPTED THIS DIRECTIVE: Article 1The aim of this Directive is to ensure that where animals are used for  experimental or other scientific purposes the provisions laid down by law, regulation or  administrative provisions in the Member States for their protection are approximated so as to avoid  affecting the establishment and functioning of the common market, in particular by distorsions of  competition or barriers to trade. Article 2For the purposes of this Directive the following definitions shall apply: (a)'animal' unless otherwise qualified, means any live non-human vertebrate, including free-living  larval and/or reproducing larval forms, but excluding foetal or embryonic forms; (b)'experimental animals' means animals used or to be used in experiments; (c)'bred animals' means animals specially bred for use in experiments in facilities approved by,  or registered with, the authority; (d)'experiment' means any use of an animal for experimental or other scientific purposes which may  cause it pain, suffering, distress or lasting harm, including any course of action intended, or  liable, to result in the birth of an animal in any such condition, but excluding the least painful  methods accepted in modern practice (i.e. 'humane' methods) of killing or marking an animal;  anexperiment starts when an animal is first prepared for use and ends when no further  observations are to be made for that experiment; the elimination of pain, suffering,  distress or lasting harm by the successful use of anaesthesia or analgesia or other methods does  not place the use of an animal outside the scope of this definition. Non experimental, agricultural  or clinical veterinary practices are excluded; (e)'authority' means the authority or authorities designated by each Member State as being  responsible for supervising the experiments within the meaning of this Directive; (f)'competent person' means any person who is considered by a Member State to be competent to  perform the relevant function described in this Directive; (g)'establishment' means any installation, building, group of buildings or other premises and may  include a place which is not wholly enclosed or covered and mobile facilities; (h)'breeding establishment' means any establishment where animals are bred with a view to their  use in experiments; (i)'supplying establishment' means any establishment, other than a breeding establishment, from  which animals are supplied with a view to their use in experiments; (j)'user establishment' means any establishment where animals are used for experiments; (k)'properly anaesthetized' means deprived of sensation by methods of anaesthesia (whether local  or general) as effective as those used in good veterinary practice; (l)'humane method of killing' means the killing of an animal with a minimum of physical and mental  suffering, depending on the species. Article 3This Directive applies to the use of animals in experiments which are undertaken for one  of the following purposes: (a)the development, manufacture, quality, effectiveness and safety testing of drugs, foodstuffs  and other substances or products: (i)for the avoidance, prevention, diagnosis or treatment of disease, ill-health or other  abnormality or their effects in man, animals or plants; (ii)for the assessment, detection, regulation or modification of physiological conditions in man,  animals or plants; (b)the protection of the natural environment in the interests of the health or welfare of man or  animal. Article 4Each Member State shall ensure that experiments using animals considered as endangered  under Appendix I of the Convention on International Trade in Endangered Species of Fauna and Flora  and Annex C.I. of Regulation (EEC) N° 3626/82 (1) are prohibited unless they are in conformity with  the above Regulation and the objects of the experiment are: - research aimed at preservation of the species in question, or- essential biomedical purposes  where the species in question exceptionally proves to be the only one suitable for those purposes. Article 5Member States shall ensure that, as far as the general care and accommodation of animals  is concerned: (a)  all experimental animals shall be provided with housing, an environment, at least some freedom  of movement, food, water and care which are appropriate to their health and well-being; (b)  any restriction on the extent to which an experimental animal can satisfy its physiological  and ethological needs shall be limited to the absolute minimum; (c)  the environmental conditions in which experimental animals are bred, kept or used must be  checked daily; (d)  the well-being and state of health of experimental animals shall be observed by a competent  person to prevent pain or avoidable suffering, distress or lasting harm; (e)  arrangements are made to ensure that any defect or suffering discovered is eliminated as  quickly as possible. For the implementation of the provisions of paragraphs (a) and (b), Member States shall pay regard  to the guidelines set out in Annex II. Article 61.  Each Member State shall designate the authority or authorities responsible for  verifying that the provisions of this Directive are properly carried out. 2.  In the framework of the implementation of this Directive, Member States shall adopt the  necessary measures in order that the designated authority mentioned in paragraph 1 above may have  the advice of experts competent for the matters in question. (1) OJ N° L 384, 31. 12. 1982, p. 1. Article 71.  Experiments shall be performed solely by competent authorized persons, or under the  direct responsibility of such a person, or if the experimental or other scientific project  concerned is authorized in accordance with the provisions of national legislation. 2.  An experiment shall not be performed if another scientifically satisfactory method of obtaining  the result sought, not entailing the use of an animal, is reasonably and practicably available. 3.  When an experiment has to be performed, the choice of species shall be carefully considered  and, where necessary, explained to the authority. In a choice between experiments, those which use  the minimum number of animals, involve animals with the lowest degree of neurophysiological  sensitivity, cause the least pain, suffering, distress or lasting harm and which are most likely to  provide satisfactory results shall be selected. Experiments on animals taken from the wild may not be carried out unless experiments on other  animals would not suffice for the aims of the experiment. 4.  All experiments shall be designed to avoid distress and unnecessary pain and suffering to the  experimental animals. They shall be subject to the provisions laid down in Article 8. The measures  set out in Article 9 shall be taken in all cases. Article 81.  All experiments shall be carried out under general or local anaesthesia. 2.  Paragraph 1 above does not apply when: (a)  anaesthesia is judged to be more traumatic to the animal than the experiment itself; (b)  anaesthesia is incompatible with the object of the experiment. In such cases appropriate  legislative and/or administrative measures shall be taken to ensure that no such experiment is  carried out unnecessarily. Anaesthesia should be used in the case of serious injuries which may cause severe pain. 3.  If anaesthesia is not possible, analgesics or other appropriate methods should be used in order  to ensure as far as possible that pain, suffering, distress or harm are limited and that in any  event the animal is not subject to severe pain, distress or suffering. 4.  Provided such action is compatible with the object of the experiment, an anaesthetized animal,  which suffers considerable pain once anaesthesia has worn off, shall be treated in good time with  pain-relieving means or, if this is not possible, shall be immediately killed by a humane method. Article 91.  At the end of any experiment, it shall be decided whether the animal shall be kept  alive or killed by a humane method, subject to the condition that it shall not be kept alive if,  even though it has been restored to normal health in all other respects, it is likely to remain in  lasting pain or distress. 2.  The decisions referred to in paragraph 1 shall be taken by a competent person, preferably a  veterinarian. 3.  Where, at the end of an experiment: (a)  an animal is to be kept alive, it shall receive the care appropriate to its state of health,  be placed under the supervision of a veterinarian or other competent person and shall be kept under  conditions conforming to the requirements of Article 5. The conditions laid down in this  subparagraph may, however, be waived where, in the opinion of a veterinarian, the animal would not  suffer as a consequence of such exemption; (b)  an animal is not to be kept alive or cannot benefit from the provisions of Article 5  concerning its well-being, it shall be killed by a humane method as soon as possible. Article 10Member States shall ensure that any re-use of animals in experiments shall be  compatible with the provisions of this Directive. In particular, an animal shall not be used more than once in experiments entailing severe pain,  distress or equivalent suffering. Article 11Notwithstanding the other provisions of this Directive, where it is necessary for the  legitimate purposes of the experiment, the authority may allow the animal concerned to be set free,  provided that it is satisfied that the maximum possible care has been taken to safeguard the  animal's well-being, as long as its state of health allows this to be done and there is no danger  for public health and the environment. Article 121.  Member States shall establish procedures whereby experiments themselves or the  details of persons conducting such experiments shall be notified in advance to the authority. 2.  Where it is planned to subject an animal to an experiment in which it will, or may, experience  severe pain which is likely to be prolonged, that experiment must be specifically declared and  justified to, or specifically authorized by, the authority. The authority shall take appropriate  judicial or administrative action if it is not satisfied that the experiment is of sufficient  importance for meeting the essential needs of man or animal. Article 131.  On the basis of requests for authorization and notifications received, and on the  basis of the reports made, the authority in each Member State shall collect, and as far as possible  periodically make publicly available, the statistical information on the use of animals in  experiments in respect of: (a)  the number and kinds of animals used in experiments; (b)  the number of animals, in selected categories, used in the experiments referred to in Article  3; (c)  the number of animals, in selected categories, used in experiments required by legislation. 2.  Member States shall take all necessary steps to ensure that the confidentiality of commercially  sensitive information communicated pursuant to this Directive is protected. Article 14Persons who carry out experiments or take part in them and persons who take care of  animals used for experiments, including duties of a supervisory nature, shall have appropriate  education and training. In particular, persons carrying out or supervising the conduct of experiments shall have received  instruction in a scientific discipline relevant to the experimental work being undertaken and be  capable of handling and taking care of laboratory animals; they shall also have satisfied the  authority that they have attained a level of training sufficient for carrying out their tasks. Article 15Breeding and supplying establishments shall be approved by or registered with, the  authority and comply with the requirements of Articles 5 and 14 unless an exemption is granted  under Article 19 (4) or Article 21. A supplying establishment shall obtain animals only from a  breeding or other supplying establishment unless the animal has been lawfully imported and is not a  feral or stray animal. General or special exemption from this last provision may be granted to a  supplying establishment under arrangements determined by the authority. Article 16The approval or the registration provided for in Article 15 shall specify the competent  person responsible for the establishment entrusted with the task of administering, or arranging for  the administration of, appropriate care to the animals bred or kept in the establishment and of  ensuring compliance with the requirements of Articles 5 and 14. Article 171.  Breeding and supplying establishments shall record the number and the species of  animals sold or supplied, the dates on which they are sold or supplied, the name and address of the  recipient and the number and species of animals dying while in the breeding or supplying  establishment in question. 2.  Each authority shall prescribe the records which are to be kept and made available to it by the  person responsible for the establishments mentioned in paragraph 1; such records shall be kept for  a minimum of three years from the date of the last entry and shall undergo periodic inspection by  officers of the authority. Article 181.  Each dog, cat or non-human primate in any breeding, supplying or user establishment  shall, before it is weaned, be provided with an individual identification mark in the least painful  manner possible except in the cases referred to in paragraph 3. 2.  Where an unmarked dog, cat or non-human primate is taken into an establishment for the first  time after it has been weaned it shall be marked as soon as possible. 3.  Where a dog, cat or non-human primate is transferred from one establishment as referred to in  paragraph 1 to another before it is weaned, and it is not practicable to mark it beforehand, a full  documentary record, specifying in particular its mother, must be maintained by the receiving  establishment until it can be so marked. 4.  Particulars of the identity and origin of each dog, cat or non-human primate shall be entered  in the records of each establishment. Article 191.  User establishments shall be registered with, or approved by, the authority.  Arrangements shall be made for user establishments to have installations and equipment suited to  the species of animals used and the performance of the experiments conducted there; their design,  construction and method of functioning shall be such as to ensure that the experiments are  performed as effectively as possible, with theobject of obtaining consistent results with the  minimum number of animals and the minimum degree of pain, suffering, distress or lasting harm. 2.  In each user establishment: (a)  the person or persons who are administratively responsible for the care of the animals and the  functioning of the equipment shall be identified; (b)  sufficient trained staff shall be provided; (c)  adequate arrangements shall be made for the provision of veterinary advice and treatment; (d)  a veterinarian or other competent person should be charged with advisory duties in relation to  the well-being of the animals. 3.  Experiments may, where authorized by the authority, be conducted outside user establishments. 4.  In user establishments, only animals from breeding or supplying establishments shall be used  unless a general or special exemption has been obtained under arrangements determined by the  authority. Bred animals shall be used whenever possible. Stray animals of domestic species shall  not be used in experiments. A general exemption made under the conditions of this paragraph may not  extend to stray dogs and cats. 5.  User establishments shall keep records of all animals used and produce them whenever required  to do so by the authority. In particular, these records shall show the number and species of all  animals acquired, from whom they were acquired and the date of their arrival. Such records shall be  kept for a minimum of three years and shall be submitted to the authority which asks for them. User  establishments shall be subject to periodic inspection by representatives of the authority. Article 20When user establishments breed animals for use in experiments on their own premises,  only one registration or approval is needed for the purposes of Article 15 and 19. However, the  establishments shall comply with the relevant provisions of this Directive concerning breeding and  user establishments. Article 21Animals belonging to the species listed in Annex I which are to be used in experiments  shall be bred animals unless a general or special exemption has been obtained under arrangements  determined by the authority. Article 221.  In order to avoid unnecessary duplication of experiments for the purposes of  satisfying national or Community health and safety legislation, Member States shall as far as  possible recognize the validity of data generated by experiments carried out in the territory of  another Member State unless further testing is necessary in order to protect public health and  safety. 2.  To that end, Member States shall, where practicable and without prejudice to the requirements  of existing Community Directives, furnish information to the Commission on their legislation and  administrative practice relating to animal experiments, including requirements to be satisfied  prior to the marketing of products; they shall also supply factual information on experiments  carried out in their territory and on authorizations or any other administrative particulars  pertaining to these experiments. 3.  The Commission shall establish a permanent consultative committee within which the Member  States would be represented, which will assist the Commission in organizing the exchange of  appropriate information, while respecting the requirements of confidentiality, and which will also  assist the Commission in the other questions raised by the application of this Directive. Article 231.  The Commission and Member States should encourage research into the development and  validation of alternative techniques which could provide the same level of information as that  obtained in experiments using animals but which involve fewer animals or which entail less painful  procedures, and shall take such other steps as they consider appropriate to encourage research in  this field. The Commission and Member States shall monitor trends in experimental methods. 2.  The Commission shall report before the end of 1987 on the possibility of modifying tests and  guidelines laid down in existing Community legislation taking into account the objectives referred  to in paragraph 1. Article 24This Directive shall not restrict the right of the Member States to apply or adopt  stricter measures for the protection of animals used in experiments or for the control and  restriction of the use of animals for experiments. In particular, Member States may require a prior  authorization for experiments or programmes of work notified in accordance with the provisions of  Article 12 (1). Article 251.  Member States shall take the measures necessary to comply with this Directive by 24  November 1989. They shall forthwith inform the Commission thereof. 2.  Member States shall communicate to the Commission the provisions of national law which they  adopt in the field covered by this Directive. Article 26At regular intervals not exceeding three years, and for the first time five years  following notification of this Directive, Member States shall inform the Commission of the measures  taken in this area and provide a suitable summary of the information collected under the provisions  of Article 13. The Commission shall prepare a report for the Council and the European Parliament. Article 27This Directive is addressed to the Member States. Done at Brussels, 24 November 1986. For the CouncilThe PresidentW. WALDEGRAVE