Amended proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE AMENDING THE DIRECTIVE PROPOSAL ON IN VITRO DIAGNOSTIC MEDICAL DEVICES
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 20. 12. 1996 COM(96) 643 final 95/0013 (COD) Amended proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE THE DIRECTIVE PROPOSAL ON IN VITRO DIAGNOSTIC MEDICAL DEVICES AMENDING (presented by the Commission pursuant to Article 189 a (2) of the EC-Treaty) EXPLANATORY MEMORANDUM In response to the European Parliament's opinion of 14 March 1996 on the proposal for a European Parliament and Council Directive on in vitro diagnostic medical devices, pursuant to Article 189a(2) of the EC Treaty the Commission has decided to amend the abovementioned proposal. The Commission has approved the amendments concerning: * * * * * * * * * * improvements to the wording to clarify the text (amendments 2, 5, 10, 11, 24, 28, 29 and 30); clearer demarcation of the scope in comparison with Directive 89/392/EEC relating to machinery (amendment 4); the clarification that the aspects concerning medical prescriptions for devices are not affected by the harmonization (amendment 15); the scope, to include in vitro diagnostic medical devices for health monitoring purposes (amendment 8); the tightening-up of the protection requirements with a view, in particular, to minimizing the risks, including the risks relating to the packaging (amendments 1, 3, 41, 42, 44, 46, 47 (in part), 48,49, 50 and 58); the clarification of the powers of the Member States' authorities and the strengthening of their market surveillance powers (amendments 6, 14, 16, 23, 25 and 29); the establishment of a European Union databank on the products placed on the market (amendments 21 (in part) and 26); extension of the group of in vitro diagnostic devices which must be submitted to third-party certification before they are placed on the market (amendment 56); the inclusion in the scope of Directive 93/42/EEC of certain medical devices manufactured using products derived from human tissues or cells (amendments 33, 36, 37, 38 and 39); the amendments to Directive 93/42/EEC to bring it closer into line with this Directive (amendments 30, 32 and 34). OJ L 183, 29. 6. 1989, p. 9 , last modified by Directive 93/68/EEC, OJ L 220, 30. 8. 1996, p. 1 The Commission has not approved the amendments concerning: * * * * * * * * deletion of the 19th recital (amendment 7). This recital states the grounds for several provisions in the proposal; the obligation that the information accompanying the products placed on the market must be available in the national language(s) (amendments 17 and 35). The proposal already ensures adequate protection for users, while reserving for the Member States the right to require availability in the national languages; the type of Committee (amendment 18). The measures which must be taken in the context of the Committee procedure will have an impact on health protection standards; consequently, for the sake of consistency with the other Directives on medical devices, procedure Ilia in Council Decision 87/373/EEC must be retained; application of the transitional system for notification of devices placed on the market to all Member States (final part of amendment 21). No such system is necessary; it would be better to establish a Community system as soon as the Directive enters into force; the list of products in Annex 2 for which the Directive requires third-party certification before they are placed on the market (amendments 55, 57 and 71). In view of their design, devices for self-testing are already subject to third-party certification, pursuant to the Commission proposal. For the other products concerned, the proposal already provides adequate protection. There is no justification for tightening up the requirements for third-party certification; the amendment to the definition of "placing on the market" in Directive 93/42/EEC (amendment 31). The amendments made to Directive 93/42/EEC by this Directive must be limited to cases concerning consistency between the two Directives; the amendment Amendment 4, which supports retention of the Commission proposal, has been preferred; to Directive 89/392/EEC to machinery (amendment 40). relating certain technical points (amendments 20, 43 and 54). No amendments are needed on these points. INITIAL TEXT MODIFIED TEXT I. Recital 3 Whereas the harmonization of national legislations is the only means of removing these barriers to free trade and preventing new barriers; whereas this objective cannot be achieved in a satisfactory manner at another level by the individual Member States; whereas this Directive only lays down necessary and sufficient requirements for the free circulation of the in vitro diagnostic medical devices to which it is applicable; Whereas the harmonization of national legislations is the only means of removing these barriers to free trade and preventing new barriers; whereas this objective cannot be achieved in a satisfactory manner at another level by the individual Member States; whereas this Directive only lays down necessary and sufficient requirements for the free circulation, in the best possible safety conditions of the in vitro diagnostic medical devices to which it is applicable; II. Recital 5 Whereas in vitro diagnostic medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer; whereas, therefore, the maintenance or improvement of the level of protection attained in the Member States is one of the essential objectives of this Directive; Whereas in vitro diagnostic medical devices should provide patients, users and third parties with a high level of health protection and attain the performance levels originally attributed to them by the manufacturer; whereas, therefore, the maintenance or improvement of the level of health protection attained in the Member States is one of the essential objectives of this Directive; HI. Recital 6 Whereas, in accordance with the principles set out in the Council resolution of 7 May 1985 concerning a new approach to technical harmonization and standardization, rules regarding the design and manufacture of relevant products must be confined to the provisions required to meet the essential requirements; whereas because they are essential, such requirements should replace the corresponding national provisions; whereas the essential requirements, including requirements to minimize and reduce risks, should be applied with discretion, taking into account the technology and practice at the time of design and of technical and economic considerations compatible with a high level of protection of health and safety Whereas, in accordance with the principles set out in the Council resolution of 7 May 1985 concerning a new approach to technical harmonization and standardization, rules regarding the design, manufacture and packaging of relevant products must be confined to the provisions required to meet the essential requirements; whereas because they are essential, such requirements should replace the corresponding national provisions; whereas the essential requirements, including requirements to minimize and reduce risks, should be applied with discretion, taking into account the technology and practice at the time of design and of technical and economic considerations compatible with a high level of protection of health and safety - 5- INITIALTEXT MODIFIED TEXT IV. Recital 9a (new) Whereas mechanical laboratory equipment especially designed for in vitro diagnostic examinations falls within the scope of this Directive; whereas, therefore, in order to harmonize the relevant Directives, Directive 89/392/EEC2 as last amended by Directive 93/68/EEC3 should be appropriately amended to bring it into line with this Directive V. Recital 15 Whereas the list of in vitro diagnostic medical devices to be subjected to third party conformity assessment needs updating, taking account of technological progress and of evolution in the domain of protection of health; whereas such updating measures must be taking in line with the procedure Ilia as laid down in Council Decision 87/373/EEC; whereas a system of adverse incident reporting (vigilance) constitutes a useful tool for the surveillance of the market, including the performance of new devices, whereas information obtained from vigilance as well as from external quality assessment schemes becomes useful for decision-making on classification of devices. Whereas the list of in vitro diagnostic medical devices to be subjected to third party conformity assessment needs updating, taking account of technological progress and of evolution in the domain of protection of health; whereas such updating measures must be taking in line with the procedure Ilia as laid down in Council Decision 87/373/EEC; whereas an agreement on a "modus vivendi" between the European Parliament, the Council and the Commission concerning the implementation measures of the acts adopted pursuant to the procedure referred to in Article 189b of the EC Treaty took place on 20 December 1994; whereas a system of adverse incident reporting (vigilance) constitutes a useful tool for the surveillance of the market, including the performance of new devices placed on the market, whereas information obtained from vigilance as well as from external quality assessment schemes becomes useful for decision making on classification of devices. OJL 183, 29. 6. 1989, p. 9 OJL 220, 30. 8. 1993, p. 1 - 6- INITIALTEXT MODIFIED TEXT VI. Recital 18 Whereas the competent authorities in charge of market surveillance must be able, particularly in emergencies, to contact the manufacturer or his authorized representative established in the Community; whereas cooperation and exchange of information between Member Sates are necessary in view of uniform application of this Directive, in particular for the purpose of market surveillance; Whereas the competent authorities in charge of market surveillance must be able, particularly in emergencies, to contact the manufacturer or his authorized representative established in the Community, in order to take any protection measures that should prove necessary; whereas cooperation and exchange of information between Member Sates are necessary in view of uniform application of this Directive, in particular for the purpose of market surveillance; VII. ARTICLE 1 (1) 1. This Directive shall apply to in vitro diagnostic medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as in vitro diagnostic medical devices in their own right. Both in vitro diagnostic medical devices and accessories shall hereinafter be termed devices. 1. This Directive shall apply to in vitro diagnostic medical devices, including therapy monitoring devices for diagnostic purpose , and their accessories. For the purposes of this Directive, accessories shall be treated as in vitro diagnostic medical devices in their own right. Both in vitro diagnostic medical devices, including therapy monitoring devices for diagnostic purposes and accessories shall hereinafter be termed devices. VIII. ARTICLE 1 (2) (b), 1st subparagraph b) "in vitro diagnostic medical device" means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health or disease or congenital abnormality or to determine the safety and compatibility with potential recipients. For the purpose of this directive, a specimen receptacle, whether evacuated or not, specifically intended by its manufacturer to contain a specimen for the purpose of in vitro diagnostic examination is considered to be a device; b) "in vitro diagnostic medical device" means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, pathological state or congenital abnormality or to determine the safety and compatibility with potential recipients. For the purpose of this directive, a specimen receptacle, whether a vacuum-type or not, specifically intended by its manufacturer to contain a specimen for the purpose of in vitro diagnostic examination is considered to be a device; 7- INITIAL TEXT MODIFIED TEXT IX. ARTICLE l(2)(e) (e) "Device for performance evaluation" means any device intended by the manufacturer to be subject to one or more performance evaluation studies in clinical laboratories or in other appropriate environments outside his own premises; (e) "Device for performance evaluation" means any device intended by the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analysis or in other appropriate environments outside his own premises; X. ARTICLE 2 Member States shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they comply with the requirements laid down in this Directive when properly installed, maintained and used in accordance with their intended purpose. 1. Member States shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they comply with the requirements laid down in this Directive when properly supplied, installed, maintained and used in accordance with their intended purpose. 2. Member States shall continuously monitor the safety and quality of devices placed on the market. XL XII. ARTICLE 3a (new) This Directive shall not affect national laws which provide for the supply of diagnostic medical devices by a medical prescription. ARTICLE 4(2) 2. At trade fairs, exhibitions, demonstrations, Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that a visible sign clearly indicates that such devices cannot be marketed or put into service until they have been made to comply. 2. At trade fairs, exhibitions, demonstrations or scientific and technical meetings. Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that a visible sign clearly indicates that such devices cannot be marketed or put into service until they have been made to comply. 8- INTTIALTEXT MODIFIED TEXT XIII. ARTICLE 10, title Registration of manufacturers Registration of manufacturers and devices XIV. ARTICLE 11(3) 3. After carrying out an assessment, if possible together with the manufacturer, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of the incidents referred to in paragraph 1 for which relevant measures have been taken or are contemplated. 3. After carrying out an assessment, if possible together with the manufacturer, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of the incidents referred to in paragraph 1 for which relevant measures, including possible withdrawal, have been taken or are contemplated. XV. ARTICLE 11(4), introduction 4. Where, in the context of notification referred to in Article 10, a device notified, bearing a CE marking, is a "new" product, the manufacturer shall indicate this fact on his notification. The competent authority so notified may at any time within the following two years and on justified grounds, require the manufacturer to submit a report relating to the experience with the device subsequent to its being placed on the market. For this purpose, a device is "new" if: 4. Where, in the context of notification referred to in Article 10, a device notified, bearing a CE marking, is a "new" product, the manufacturer shall indicate this fact on his notification. The competent authority so notified may at any time within the following two years and on justified grounds, require the manufacturer to submit a report relating to the experience gained with the device subsequent to its being placed on the market. For this purpose, a device is "new" if XVI. ARTICLE ll(5a) (new) 5a. In addition, the data provided by the manufacturers in accordance with Article 10 shall be stored in a Community database accessible to the competent authorities to enable them to conduct vigilance on a well-informed basis. Such data is to be forwarded in a standardized format. - 9- INITIALTEXT MODIFIED TEXT XVII. ARTICLE 13(2) 2. Member States shall apply the criteria set out in Annex 9 for the designation of bodies. Bodies that meet the criteria laid down in the national standards which transpose the relevant harmonised standards shall be presumed to meet the relevant criteria. 2. Member States shall apply the criteria set out in Annex 9 for the designation of bodies. Bodies that meet the criteria laid down in the national standards which transpose the relevant harmonised standards shall be presumed to meet the criteria applicable in accordance with the said Annex 9. XVIII. ARTICLE 16(2) 2. In the event of a decision as referred to in paragraph 1, the manufacturer, or his authorized representative established in the Community, shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not possible because of the urgency of the measure to be taken. 2. In the event of a decision as referred to in paragraph 1, the manufacturer, or his authorized representative established in the Community, shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not possible because of the urgency of the measure to be taken, as justified by public health requirements. XIX ARTICLE 19(l)(a) Article l(2)(c) (Directive 93/42/EEC) "(c) in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health or disease or congenital abnormality or to determine the safety and compatibility with potential recipients". "(c) in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, pathological state or congenital abnormality or to determine the safety and compatibility with potential recipients". - 10- INITIALTEXT MODIFIED TEXT XX. ARTICLE 19(l)(ab)(new) Article 1(2) (ia) (new) (Directive 93/42/EEC0 (ab). In article 1(2), the following point (ia) shall be added : "(ia) authorized representative means the natural or legal person as established within the Community who, being explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community in substitution for the manufacturer with regard to the latter's obligations in accordance with this Directive". XXI. ARTICLE 19(l)(b) Article l(5)(f) (Directive 93/42/EEC) "(f) transplants or tissues or cells of human origin, unless a device is manufactured utilizing tissues or substances derived from such tissues which are non viable or rendered non viable. In this case, the directive shall not affect national regulations relating to the ethics of the collection of tissues or substances of human origin, as well as any regulations relating to the ethics governing distribution of given types of devices of such origin. " "(f) transplants or tissues or cells of human origin, unless a medical device is manufactured utilizing cells or tissue of human origin having undergone a process of transformation which removes the cellular organization or the characteristic structure of the tissue of origin and renders such material non viable. In this case, the directive shall not affect national regulations relating to the ethics of the collection of tissues or substances of human origin, as well as any regulations relating to the ethics governing distribution of given types of devices of such origin. " XXII. ARTICLE 19(l)(ba)(new) Article 2 (Directive 93/42/EEC) (ba) Article 2 shall read as follows : "Article 2 Member States shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they comply with the requirements laid down in this Directive when properly supplied, installed, maintained and used in accordnace with their intended purpose. " -11 INITIAL TEXT MODIFIED TEXT XXIII. ARTICLE 19(l)(c) Annex 1(8. 2), 1st subparagraph (Directive 93/42/EEC) "8. 2. Where a device is manufactured utilizing human tissues or substances derived from human tissues, the use of such tissues or substances must be subject to the relevant validated selection and screening procedures, including traceability as appropriate in relation to the inherent risk. "8. 2. Where a medical device is manufactured utilizing human tissues or cells or substances derived from human tissues, as described in Article l(5Xf) above, the use thereof must be subject to the relevant validated selection and screening procedures, including traceability as appropriate in relation to the inherent risk. " XXIV. ARTICLE 19(l)(d) Annex I (13. 3) (n) (Directive 93/42/EEC) n) in the case of devices incorporating tissues of human origin or substances derived from such tissues, a statement indicating that the device incorporates tissue or substances derived from tissue of human origin as appropriate "n) in the case of medical devices which, during manufacture, utilize cells or tissues of human origin or substances derived from such tissues, a statement indicating that the medical device contains substances of human origin;" XXV. ARTICLE 19(l)(e) Annex II (3. 2) (c) and Annex III (3), third last indent (Directive 93/42/EEC) - in the case of devices incorporating tissues of human or animal origin, information on the selection and origin; "- in the case of medical devices manufactured using substances derived from cells or tissues of human or animal origin, information on the selection and origin;" XXVI. ARTICLE 19 (l)(f) Annex IX (III) (4. 5), last subparagraph (Directive 93/42/EEC) All devices manufactured utilizing human tissues or substances derived from such tissues are in class III. "All medical devices which during their manufacture utilize cells or tissues of human origin or substances produced therefrom are in class in. " -12 INITIAL TEXT MODIFIED TEXT XXVII. ANNEX 1(1) 1. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise, directly or indirectly, the clinical condition or the safety of the patients, the safety and health of users and, where applicable, other persons, and the safety of property. Any risks, which may be associated with their use, must be acceptable when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. 1. The devices must be designed^ manufactured and packaged in such a way that, when used under the conditions and for the purposes intended, they will not compromise, directly or indirectly, the clinical condition or the safety of the patients, the safety and health of users and, where applicable, other persons, and the safety of property. Any risks, which may be associated with their use, must be acceptable when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety XXVIII. ANNEX 1(2), 2nd subparagraph, 1st indent - eliminate or reduce risks as far as possible (inherently safe design and construction) - eliminate or reduce risks as far as possible (inherently safe design, construction, and packaging) XXIX. ANNEX 1 (6. 1) and (6. 2) 6. 1. The devices must be designed and manufactured in such a way as to achieve the characteristics and performances referred to in Section I on the "General Requirements". Attention must be paid to the possibility of impairment of analytical performance due to incompatibility between the materials used and the samples (such as biological tissues, cells, body fluids and micro-organisms) intended to be used with the device, taking account of its intended purpose. 6. 2. The devices must be designed, manufactured and packed in such a way as to reduce as far as possible the risk posed by leakage products, contaminants and residues to the persons involved in the transport, storage and use of the devices, taking account of the intended purpose of the products. 6. 1. The devices must be designed^ manufactured and packaged in such a way as to achieve the characteristics and performances referred to in Section I on the "General Requirements". Attention must be paid to the possibility of impairment of analytical performance due to incompatibility between the materials used and the samples (such as biological tissues, cells, body fluids and micro-organisms) intended to be used with the device, taking account of its intended purpose. 6. 2. The devices must be designed, manufactured and packed in such a way as to reduce to the minimum the risk posed by product leakage, contaminants and residues to the persons involved in the transport, storage and use of the devices, taking account of the intended purpose of the products. 13 INITIAL TEXT MODIFIED TEXT XXX. ANNEX 1(7. 1) 7. 1. The devices must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the user or other persons. The design must allow easy handling and, where necessary, reduce as far as possible contamination of and leakage from the device during use and, in the case of specimen receptacles, the risk of contamination of the specimen. The manufacturing processes must be appropriate for these purposes 7. 1. The devices must be designed in such a way as to eliminate or reduce to the minimum all risk of infection to the user or other persons. The design must allow easy handling and, where necessary, reduce as far as possible contamination of and leakage from the device during use and, in the case of specimen receptacles, the risk of contamination of the specimen. The manufacturing processes must be appropriate for these purposes XXXI. ANNEX 1 (7. 2) 7. 2. Where a device incorporates biological substances, the risks of infection must be reduced as far as possible by selecting appropriate donors, appropriate substances and using appropriate inactivation, conservation, test and control procedures. 7. 2. Where a device incorporates biological substances, all risk of infection to the user or other persons must be eliminated or reduced to the minimum by selecting appropriate donors, appropriate substances and using appropriate inactivation, conservation, test and control procedures. XXXII. ANNEX 1 (7. 5) Packaging systems for devices other than those 7. 5. referred to in section 7. 3 must keep the product without deterioration at the level of cleanliness, if any, as indicated by the manufacturer and, if the devices are to be sterilized prior to use, reduce as far as possible the risk of microbial contamination. Steps shall be taken to reduce microbial contamination during selection and handling of raw materials, manufacture, storage and distribution where the performance of the device can be adversely affected by such contamination. Packaging systems for devices other 7. 5. than those referred to in section 7. 3 must keep the product without deterioration at the level of cleanliness, if any, as indicated by the manufacturer and, if the devices are to be sterilized prior to use, reduce to the minimum the risk of microbial contamination. Step» shall be taken to reduce as far as possible microbial contamination during selection and handling of raw materials, manufacture, storage and distribution where the performance of the device can be adversely affected by such contamination. 14- INITIALTEXT MODIFIED TEXT XXXIII. ANNEX 1 (8. 3) and (8. 4) 8. 3. Devices must be designed and manufactured in such a way as to reduce as far as possible the risks of fire or explosion during normal use. Particular attention must be paid to devices whose intended use includes exposure to or use in association with flammable substances or substances which could cause combustion. 8. 3. Devices must be designed^ manufactured and packaged in such a way as to reduce as far as possible the risks of fire or explosion during normal use. Particular attention must be paid to devices whose intended use includes exposure to or use in association with flammable substances or substances which could cause combustion. 8. 4. Devices must be designed and manufactured in such a way as to facilitate the management of safe waste disposal. 8. 4. Devices must be designed. , manufactured and packaged in such a way as to facilitate the management of safe waste disposal. XXXIV. ANNEX 1 (12), introduction and (1) Devices for self-testing must be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to users and the influence resulting from variation that can reasonably be anticipated in users' technique and environment. The information and instructions provided by the manufacturer should be easily understood and applied by the user. 12. 1 Devices for self-testing must be designed and manufactured in such a way as to reduce as far as practicable the risk of user's error in handling and in interpretation of the result. Devices for self-testing must be designed. , manufactured and packaged in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to users and the influence resulting from variation that can reasonably be anticipated in users' technique and environment. The information and instructions provided by the manufacturer should be easily understood and applied by the user. 12. 1 Devices for self-testing must be designed. , manufactured and packaged in such a way as to reduce as far as practicable the risk of user's error in handling and in interpretation of the result. - 1 5- INITLALTEXT MODIFIED TEXT XXXIV. ANNEX 2(2) 2. Reagents and reagent products for the detection in human specimens of markers of HIV infection, Hepatitis B and C; 2. Reagents and reagent products for the detection in human specimens of markers of HIV infection, Hepatits B and C. Rubella and toxoplasmosis. XXXVI. ANNEX 7 (3. 2), 3rd subparagraph (d) (d) the appropriate tests and trials to be carried out before, during and after manufacture, the frequency with which they will take place, and the test equipment used; it must be possible adequately to trace back the calibration of the test equipment. (d) the appropriate tests and trials to be carried out before, during and after manufacture, the frequency with which they will take place, and the equipment used; the calibration of this equipment must be such as to guarantee adequate traceability. /It- ISSN 0254-1475 COM(96) 643 final DOCUMENTS EN 15 05 Catalogue number : CB-C0-96-641-EN-C ISBN 92-78-13009-5 Office for Official Publications of the European Communities L-2985 Luxembourg