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31992L0026

1992

Council Directive 92/26/EEC of 31 March 1992 concerning the classification for the supply of medicinal products for human use 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 measures aimed at progressively establishing the internal market over a period expiring on 31 December 1992 need to be taken; whereas the internal market is to comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas the conditions for the supply of medicinal products for human use to the public vary appreciably from one Member State to another; whereas medicinal products sold without prescriptions in certain Member States can be obtained only on medical prescription in other Member States; Whereas Directive 91/28/EEC(4) specifies what medicinal products may be advertized to the public; whereas, in view of the development of means of communication, the conditions governing the supply of medicinal products to the public should be harmonized. Whereas, moreover, persons moving around within the Community have the right to carry a reasonable quantity of medicinal products lawfully obtained for their personal use; whereas it must also be possible for a person established in one Member State to receive from another Member State a reasonable quantity of medicinal products intended for his personal use; whereas it is important therefore to harmonize the conditions governing the supply of medicinal products to the public; Whereas, in addition, under the new system of registration of medicinal products in the Community, certain medicinal products will be the subject of a Community marketing authorization; whereas, in this context, the classification for the supply of medicinal products covered by a Community marketing authorization needs to be established; whereas it is therefore important to set the criteria on the basis of which Community decisions will be taken; Whereas it is therefore appropriate, as an initial step, to harmonize the basic principles applicable to the classification for the supply of medicinal products in the Community or in the Member State concerned, while taking as a starting point the principles already established on this subject by the Council of Europe as well as the work of harmonization completed within the framework of the United Nations, concerning narcotic and psychotropic substances; Whereas this Directive is without prejudice to the national social security arrangements for reimbursement or payment for medicinal products on prescription, Article 1 1. This Directive concerns the classification for the supply of medicinal products for human use in the Community into: - medicinal products subject to medical prescription, - medicinal products not subject to medical prescription. 2. For the purposes of this Directive, the definition of 'medicinal product' in Article 1 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(5) as last amended by Directive 89/343/EEC(6) , shall apply. In addition, 'medicinal prescription' shall mean any prescription issued by a professional person qualified to prescribe medicinal products. Article 2 1. When a marketing authorization is granted, the competent authorities shall specify the classification of the medicinal product into: - a medicinal product subject to medical prescription, - a medicinal product not subject to medical prescription. To this end, the criteria laid down in Article 3 (1) shall apply. 2. The competent authorities may fix sub-categories for medicinal products which are available on medical prescription only. In that case, they shall refer to the following classification: (a) medicinal products on renewable or non-renewable medical prescription; (b) medicinal products subject to special medical prescription; (c) medicinal products on restricted medical prescription, reserved for use in certain specialized areas. Article 3 1. Medicinal products shall be subject to medical prescription where they: - are likely to present a danger either directly or indirectly, even when used correctly, if utilized without medical supervision, or - are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health, or - contain substances or preparations thereof the activity and/or side effects of which require further investigation, or - are normally prescribed by a doctor to be administered parenterally. 2. Where Member States provide for the sub-category of medicinal products subject to special medical prescription, they shall take account of the following factors: - the medicinal product contains, in a non-exempt quantity, a substance classified as a narcotic or a psychotropic substance within the meaning of the international conventions in force (United Nations Conventions of 1961 and 1971), or - the medicinal product is likely, if incorrectly used, to present a substantial risk of medicinal abuse, to lead to addiction or be misused for illegal purposes, or - the medicinal product contains a substance which, by reason of its novelty or properties, could be considered as belonging to that group as a precautionary measure. 3. Where Member States provide for the sub-category of medicinal products subject to restricted prescription, they shall take account of the following factors: - the medicinal product, because of its pharmaceutical characteristics or novelty or in the interests of public health, is reserved for treatments which can only be followed in a hospital environment, - the medicinal product is used in the treatment of conditions which must be diagnosed in a hospital environment or in institutions with adequate diagnostic facilities, although administration and follow-up may be carried out elsewhere, or - the medicinal product is intended for outpatients but its use may produce very serious side-effects requiring a prescription drawn up as required by a specialist and special supervision throughout the treatment. 4. A competent authority may waive application of paragraphs 1, 2 and 3 having regard to: (a) the maximum single dose, the maximum daily dose, the strength, the pharmaceutical form, certain types of packaging; and/or (b) other circumstances of use which it has specified. 5. If a competent authority does not designate medicinal products into sub-categories referred to in Article 2 (2), it shall nevertheless take into account the criteria referred to in paragraphs 2 and 3 of this Article in determining whether any medicinal product shall be classified as a prescription-only medicine. Article 4 Medicinal products not subject to prescription shall be those which do not meet the criteria listed in Article 3. Article 5 1. The competent authorities shall draw up a list of the medicinal products subject on their territory to medical prescription, specifying, if necessary, the category of classification. They shall update this list annually. 2. On the occasion of the five-yearly renewal of the marketing authorization or when new facts are brought to their notice, the competent authorities shall examine and, as appropriate, amend the classification of a medicinal product, by applying the criteria listed in Article 3. Article 6 1. Within two years of adoption of this Directive, the Member States shall communicate the list referred to in Article 5 (1) to the Commission and to the other Member States, when requested by the latter. 2. Each year, Member States shall communicate to the Commission and to the other Member States the changes that have been made to the list referred to in paragraph 1. 3. Within four years of the adoption of this Directive, the Commission shall submit a report to the Council on the application of this Directive. This report will be accompanied, if necessary, by appropriate proposals. Article 7 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1993. They shall forthwith inform the Comission 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. Article 8 This Directive is addressed to the Member States.

31992L0024

1992

Council Directive 92/24/EEC of 31 March 1992 relating to speed limitation devices or similar speed limitation on- board systems of certain categories of motor vehicles 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 it is important to adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market shall comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas the technical requirements which motor vehicles must satisfy pursuant to national laws relate, inter alia, to speed limitation of certain categories of vehicle; Whereas these requirements differ from one Member State to another; whereas it is therefore necessary for all Member States to adopt the same requirements either in addition to, or in place of, their existing rules in order to allow, in particular, the EEC type-approval procedure which was the subject of Directive 70/156/EEC (4) to be applied in respect of each type of vehicle; Whereas, with a view to improving road safety and reducing the severity of injuries in cases of accidents with heavy goods vehicles and buses, it is considered urgently necessary to fit speed limitation devices to these categories of motor vehicle; Whereas in respect of environment and economy a reduction of air pollution and fuel consumption can be achieved; Whereas, in all cases where the Council confers powers upon the Commission to implement rules laid down in the motor vehicle sector, it is appropriate to provide for a procedure of prior consultation between the Commission and the Member States within an Advisory Committee; Whereas it is reasonable and useful to undertake research activities relating to the development of variable speed limitation devices activated in conformity with the speed limits warranted by the prevailing road and traffic conditions within the framework of the Drive-programme, Article 1 For the purpose of this Directive: - 'vehicle' shall mean any motor vehicle of categories N2 and M3 with a maximum authorized mass exceeding 10 tonnes and of catetory N3, as defined in Annex I to Directive 70/156/EEC, intended for use on the road, having at least four wheels and a maximum design speed exceeding 25 km/h, - 'speed limitation device' shall mean a speed-limiting appliance for which type-approval of a separate technical unit within the meaning of Article 9a of Directive 70/156/EEC may be granted. Built-in maximum vehicle speed limitation systems, incorporated into the design of vehicles from the outset, shall meet the same requirements as speed limitation devices. Article 2 Member states may not refuse: - EEC type-approval or national type-approval for a vehicle, or refuse or prohibit the sale, registration, entry into service or use of a vehicle on grounds relating to its equipment with speed limitation devices, - EEC technical unit type-approval or national typeapproval for a speed limitation device, or prohibit the sale or use of a speed limitation device, if the requirements of the Annexes to this Directive are satisfied. Article 3 Any amendments necessary to adapt the requirements of the Annexes to this Directive to technical progress shall be adopted in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC. Article 4 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1993. They shall forthwith inform the Commission thereof. When Member States adopt the provisions referred to in the preceding subparagraph, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such a reference shall be adopted by Member States. Article 5 With effect from 1 January 1994, Member States: - may no longer issue the document provided for in the third indent of Article 10 (1) of Directive 70/156/EEC in respect of a type of vehicle of which the speed limitation device does not meet the requirements of this Directive, - may refuse to grant national type-approval in respect of a type of vehicle of which the speed limition device does not comply with the provisions of this Directive. With effet from 1 October 1994, Member States may prohibit the first entry into service of vehicles when such vehicles are not equipped with a speed limitation device complying with the provisions of this Directive. Article 6 This Directive is addressed to the Member States.

31992L0029

1992

Council Directive 92/29/EEC of 31 March 1992 on the minimum safety and health requirements for improved medical treatment on board vessels Having regard to the Treaty establishing the European Economic Community, and in particular Article 118a thereof, Having regard to the proposal from the Commission(1) , drawn up after consultation with the Advisory Committee on Safety, Hygiene and Health Protection at Work, In cooperation with the European Parliament(2) , Having regard to the Opinion of the Economic and Social Committee(3) , Whereas the Commission communication on its programme concerning safety, hygiene and health at work(4) envisages measures to ensure medical treatment at sea; Whereas the safety and health of workers on board a vessel, which constitutes a workplace involving a wide range of risks, bearing in mind, inter alia, its geographical isolation, where appropriate, require special attention; Whereas vessels should have adequate medical supplies, kept in good order and checked at regular intervals, so that workers can obtain the necessary medical treatment at sea; Whereas, in order to ensure appropriate medical treatment at sea, training and information of seafarers should be encouraged as regards the use of medical supplies; Whereas the use of long-distance medical-consultation methods constitutes an efficient way of contributing to the protection of the safety and health of workers, Article 1 Definitions For the purposes of this Directive, the following terms shall have the following meanings: (a) vessel: any vessel flying the flag of a Member State or registered under the plenary jurisdiction of a Member State, seagoing or estuary-fishing, publicly or privately owned, excluding: - inland navigation vessels, - warships, - pleasure boats used for non-commercial purposes and not manned by professional crews, - tugs operating in harbour areas. Vessels shall be classed in three categories in accordance with Annex I; (b) worker: any person carrying out an occupation on board a vessel, including trainees and apprentices, but excluding port pilots and shore personnel carrying out work on board a vessel at the quayside; (c) Owner: the registered owner of a vessel unless that vessel has been chartered by demise or is managed, either wholly or in part, by a natural or legal person other than the registered owner under the terms of a management agreement; in that case the owner shall be construed as the demise charterer or natural or legal person managing the vessel as appropriate; (d) medical supplies: medicines, medical equipment and antidotes, a non-exhaustive list of which is given in Annex II; (e) antidote: a substance used to prevent or treat a harmful effect or effects, direct or indirect, of one or more substances included on the list of dangerous substances in Annex III. Article 2 Medicines and medical equipment - Sick-bay - Doctor Each Member State shall take the measures necessary to ensure that: 1. (a) every vessel flying its flag or registered under its plenary jurisdiction always carries on board medical supplies which meet at least, in terms of quality, the specifications of Annex II sections I and II for the category of vessel to which it belongs; (b) the quantities of medicinal products and medical equipment to be carried depend on the nature of the voyage - in particular ports of call, destination, duration - the type or types of work to be carried out during the voyage, the nature of the cargo and the number of workers; (c) the content of the medicines and medical equipment included in the medical supplies shall be detailed on a checklist corresponding at least to the general framework laid down in Annex IV, sections A, B and C II 1 and II 2; 2. (a) for each of its life-rafts and life-boats, every vessel flying its flag or registered under its plenary jurisdiction carries a watertight medicine chest at least containing the medical supplies specified in Annex II, sections I and II, for category C vessels; (b) the content of these chests is also detailed on the checklist referred to in paragraph 1 (c); 3. every vessel flying its flag or registered under its plenary jurisdiction, of more than 500 gross registered tonnes, with a crew of 15 or more workers and engaged on a voyage of more than three days, has a sick-bay in which medical treatment can be administered under satisfactory material and hygienic conditions; 4. every vessel flying its flag or registered under its plenary jurisdiction, with a crew of 100 or more workers and engaged on an international voyage of more than three days, has a doctor responsible for the medical care of the workers on board. Article 3 Antidotes Each Member State shall take the measures necessary to ensure that: 1. any vessel flying its flag or registered under its plenary jurisdiction and carrying any of the dangerous substances listed in Annex III carries on board medical supplies including at least the antidotes listed in Section III of Annex II; 2. any ferry-type vessels flying its flag or registered under its plenary jurisdiction, whose conditions of operation do not always allow it to know well enough in advance the nature of the dangerous substances being transported, has on board medical supplies including at least the antidotes listed in section III of Annex II. However, on a regular where the crossing is due to last less than two hours, the antidotes may be limited to those which have to be administered in cases of extreme emergency within a period of time not exceeding the normal duration of the crossing; 3. the contents of the medical supplies, as regards antidotes, shall be detailed on a check list corresponding at least to the general framework laid down in Annex IV, sections A, B and C, II 3. Article 4 Allocation of responsibilities Each Member State shall take the measures necessary to ensure that: 1. (a) the provision and replenishment of the medical supplies of any vessel flying its flag or registered under its plenary jurisdiction are undertaken on the exclusive responsibility of the owner, without any expense to the workers; (b) the management of the medical supplies is placed under the responsibility of the captain of the vessel; he may, without prejudice to this responsibility, delegate the use and maintenance of the medical supplies to one or more workers specially designated by reason of their competence; 2. the medical supplies are maintained in good condition and replenished and/or replaced as soon as possible, and in every case as a priority part of normal revictualling procedures; 3. in an emergency established by the captain as far as possible after having obtained a medical opinion, the required medicines, medical equipment and antidotes which are not available on board are made available as soon as possible. Article 5 Information and training Each Member State shall take the measures necessary to ensure that: 1. medical supplies are accompanied by one or more guides to their use, including instructions for use of at least the antidotes required in Annex II section III; 2. all persons receiving professional maritime training and intending to work on board ship have been given basic training in the medical and emergency measures to be taken immediately in the event of an accident or serious medical emergency; 3. the captain and any worker or workers to whom he delegates the use of the medical supplies pursuant to Article 4 (1) (b) have received special training updated periodically, at least every five years, taking into account the specific risks and needs connected with the different categories of vessel and in accordance with the general guidelines set out in Annex V. Article 6 Medical consultations by radio 1. To ensure better emergency treatment for workers, each Member State shall take the measures necessary to ensure that: (a) one or more centres are designated to provide workers with free medical advice by radio; (b) some of the doctors providing their services for the radio consultation centres have been trained in the special conditions prevailing on board ship. 2. In order to optimize the advice given, the radio consultation centres may keep personal medical records, with the agreement of the workers concerned. Such records shall remain confidential. Article 7 Inspection 1. Each Member State shall take the measures necessary to ensure that a competent person or a competent authority carries out an annual inspection to check that on board all vessels flying its flag: - the medical supplies meet the minimum requirements of this Directive; - the checklist provided for in Article 2 (1) (c) confirms that the medical supplies comply with those minimum requirements; - the medical supplies are correctly stored; - any expiry dates have been respected. 2. Inspections of the medical supplies stored on life-rafts shall be carried out in the course of those life-rafts' annual maintenance. Those inspections may exceptionally be postponed for up to five months. Article 8 Committee 1. With a view to the strictly technical adaption of the Annexes to this Directive in the light of technical progress or changes in international regulations or specifications and new findings in this field, the Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission. 2. The representative of the Commission 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. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The Chairman shall not vote. 3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. If 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 relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 9 Final provisions 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1994. They shall forthwith inform the Commission thereof. When Member States adopt these measures, such measures 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 texts of the provisions of national law which they have already adopted or which they adopt in the field governed by this Directive. 3. Member States shall report to the Commission every five years on the implementation of this Directive, giving the views of the two sides of industry. The Commission shall inform the European Parliament, the Council, the Economic and Social Committee and the Advisory Committee for Safety, Hygiene and Health at Work thereof. 4. The Commission shall report at least every five years to the European Parliament, the Council and the Economic and Social Committee on the implementation of this Directive, taking into account paragraphs 1, 2 and 3. Article 10 This Directive is addressed to the Member States.

31992L0023

1992

Council Directive 92/23/EEC of 31 March 1992 relating to tyres for motor vehicles and their trailers and to their fitting 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 measures should be adopted in order gradually to establish the internal market during a period expiring on 31 December 1992; whereas the internal market comprises an entity without internal frontiers within which the free movement of goods, persons, services and capital shall be guaranteed; Whereas the total harmonization method will be essential in order fully to achieve the single market; Whereas this method will have to be used at the time of the revision of the entire EEC type-approval procedure, taking account of the spirit of the Council resolution of 7 May 1985 concerning a new approach to the question of technical harmonization and standardization; Whereas the technical requirements which motor vehicles and their trailers must satisfy pursuant to national laws relate, inter alia, to pneumatic tyres; Whereas these requirements differ from one Member State to another; whereas it is therefore necessary that all Member States adopt the same requirements either in addition to or in place of their existing rules in order to permit, in particular, the EEC type-approval procedure which was the subject of Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (4), as last amended by Directive 87/403/EEC (5), to be introduced in respect of each type of vehicle; Whereas rules on tyres should lay down common requirements concerning not only their characteristics, but also the requirements for the equipment of vehicles and their trailers with regard to their tyres; Whereas, consequently, a common procedure for granting an EEC mark to any tyre type complying with the common characteristics and test requirements should be established; whereas, at the Community level, to ensure the free movement of tyres, the conformity of the tyres with the common requirements is assured by the affixing on each tyre of an EEC mark which has been granted to the manufacturer in accordance with the abovementioned procedure; whereas any Member States may, in order to check the conformity of the tyres with the common requirements, carry out controls at any moment; whereas, in the case of a statement of non-conformity, the Member States need to take the necessary steps to ensure the conformity of the tyres with the requirements; whereas these measures may result in the withdrawal of the abovementioned EEC mark; Whereas it is desirable to take into account the technical requirements adopted by the UN Economic Commission for Europe in its Regulation N° 30 ('Uniform provisions concerning the approval of pneumatic tyres for motor vehicles and their trailers`), as amended (6), and in its Regulation N° 54 ('Uniform provisions concerning the approval of pneumatic tyres for commercial vehicles and their trailers`) (7) and in its Regulation N° 64 ('Uniform provisions concerning the approval of vehicles equipped with temporary-use spare wheels/tyres`) (8), which are annexed to the Agreement of 20 March 1958 concerning the adoption of uniform conditions for approval and reciprocal recognition of approval for motor vehicle equipment and parts; Whereas the approximation of national laws relating to motor vehicles entails reciprocal recognition by Member States of the checks carried out by each of them on the basis of the common requirements, Article 1 For the purposes of this Directive: - 'tyre` means any new pneumatic tyre designed for the equipment of vehicles ot which Council Directive 70/156/EEC applies; - 'vehicle` means any vehicle to which Council Directive 70/156/EEC applies; - 'manufacturer` means the holder of the trade name or mark of vehicles or tyres. Article 2 1. Member States shall grant EEC component type-approval under the conditions of Annex I for any tyre type which satisfies the requirements of Annex II and shall grant a EEC component type-approval number as specified in Annex I. 2. Member States shall grant EEC type-approval for a vehicle with regard to its tyres under the conditions of Annex III for any vehicle for which all the tyres (including the spare tyre, if any) satisfy the requirements of Annex II and also the requirements with regard to vehicles of Annex IV and shall grant an EEC vehicle type-approval number as specified in Annex III. Article 3 The approval authority of a Member State shall, within one month of issuing or refusing an EEC component (tyre) or vehicle type-approval, send a copy of the relevant certificate, models of which are given in the Appendices to Annex I and Annex III, to the other Member States and, if requested, send the test report on any type of tyre approved. Article 4 N° Member State may prohibit or restrict the placing on the market of tyres bearing the EEC component type-approval mark. Article 5 N° Member State may refuse to grant EEC type-approval or national type-approval to a vehicle on grounds relating to its tyres if these bear the EEC component type-approval mark and are fitted in accordance with the requirements laid down in Annex IV. Article 6 N° Member State may refuse or prohibit the sale, registration, entry into service or use of a vehicle on grounds relating to its tyres if these bear the EEC component type-approval mark and are fitted in accordance with the requirements laid down in Annex IV. Article 7 1. If, on the basis of a substantiated justification, a Member State considers that a tyre type or a vehicle type is dangerous although complying with the requirements of this Directive, it may, within its territory, provisionally prohibit the marketing of that product or subject it to special conditions. It shall immediately inform the other Member States and the Commission thereof, stating the grounds for its decision. 2. The Commission shall, within six weeks, consult the Member States concerned, following which it shall deliver its opinion without delay and take the appropriate steps. 3. If the Commission is of the opinion that technical adaptations to the Directives are necessary, such adaptations shall be adopted by either the Commission or the Council in accordance with the procedure laid down in Article 10. In this event, the Member State which has adopted safeguard measures may maintain them until the entry into force of the adaptations. Article 8 1. The Member State which has granted the EEC component (tyre) or vehicle type-approval shall take the measures required in order to verify that production models conform to the approved type in so far as this is necessary and if need be in cooperation with the approval authorities in the other Member States. For this purpose, this Member State may at any time check the conformity of the tyres or vehicles to the requirements of this Directive. Such verification shall be limited to spot checks. 2. If this Member State finds that a number of tyres or vehicles with the same approval marking do not conform to the approved type, it shall take the necessary measures to ensure that production models so conform. Where there is a consistent failure to conform, these measures may extend to a withdrawal of EEC type-approval. The said authorities shall take the same measure if they are informed by the approval authorities of another Member State of such failure to conform. 3. The approval authorities of the Member States shall within one month notify each other using the relevant form shown in the Appendices to Annex I and Annex III of any withdrawal of EEC type-approval and of the reasons for such a measure. Article 9 Any decision taken pursuant to the provisions adopted in implementation of this Directive to refuse or withdraw EEC component type-approval for a tyre or EEC type-approval of a vehicle with regard to the fitting of its tyres implying a prohibition of marketing or of use shall set out in detail the reasons on which it is based. Every such decision shall be notified to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member States and of the time limits allowed for the exercise of such remedies. Article 10 Any amendments necessary to adapt the requirements of the Annexes to technical progress shall be adopted in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC. Article 11 1. Member States shall adopt and publish the provisions necessary to comply with this Directive before 1 July 1992 and shall forthwith inform the Commission thereof. When the Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. They shall apply these measures from 1 January 1993. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 12 This Directive is addressed to the Member States.

31992L0028

1992

Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use 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 Directive 84/450/EEC(4) harmonized the laws, regulations and administrative provisions of the Member States concerning misleading advertising; whereas this Directive is without prejudice to the application of measures adopted pursuant to that Directive; Whereas all Member States have adopted further specific measures concerning the advertising of medicinal products; whereas there are disparities between these measures; whereas these disparities are likely to have an impact on the establishment and functioning of the internal market, since advertising disseminated in one Member State is likely to have effects in other Member States; Whereas Council Directive 89/552/EEC of 3 October 1989 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the pursuit of television broadcasting activities(5) prohibits the television advertising of medicinal products which are available only on medical prescription in the Member State within whose jurisdiction the television broadcaster is located; whereas this principle should be made of general application by extending it to other media; Whereas advertising to the general public, even of non-prescription medicinal products, could affect public health, were it to be excessive and ill-considered; whereas advertising of medicinal products to the general public, where it is permitted, ought therefore to satisfy certain essential criteria which ought to be defined; Whereas, furthermore, distribution of samples free of charge to the general public for promotional ends must be prohibited; Whereas the advertising of medicinal products to persons qualified to prescribe or supply them contributes to the information available to such persons; whereas, nevertheless, this advertising should be subject to strict conditions and effective monitoring, referring in particular to the work carried out within the framework of the Council of Europe; Whereas medical sales representatives have an important role in the promotion of medicinal products; whereas, therefore, certain obligations should be imposed upon them, in particular the obligation to supply the person visited with a summary of product characteristics; Whereas persons qualified to prescribe medicinal products must be able to carry out these functions objectively without being influenced by direct or indirect financial inducements; Whereas it should be possible within certain restrictive conditions to provide samples of medicinal products free of charge to persons qualified to prescribe or supply them so that they can familiarize themselves with new products and acquire experience in dealing with them; Whereas persons qualified to prescribe or supply medicinal products must have access to a neutral, objective source of information about products available on the market; whereas it is nevertheless for the Member States to take all measures necessary to this end, in the light of their own particular situation; Whereas advertising of medicinal products should be subject to effective, adequate monitoring; whereas reference in this regard should be made to the monitoring mechanisms set up by Directive 84/450/EEC; Whereas each undertaking which manufactures or imports medicinal products should set up a mechanism to ensure that all information supplied about a medicinal product conforms with the approved conditions of use, CHAPTER I Scope, definitions and general principles Article 1 1. This Directive concerns the advertising in the Community of medicinal products for human use covered by Chapters II to V of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(6) . 2. For the purposes of this Directive: - the definitions of the name of the medicinal product and of the common name shall be those laid down in Article 1 of Directive 92/27/EEC(7) ; - the summary of product characteristics shall be the summary approved by the competent authority which granted the marketing authorization in accordance with Article 4b of Directive 65/65/EEC. 3. For the purposes of this Directive, advertising of medicinal products shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products; it shall include in particular: - the advertising of medicinal products to the general public, - advertising of medicinal products to persons qualified to prescribe or supply them, - visits by medical sales representatives to persons qualified to prescribe medicinal products, - the supply of samples, - the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal, - sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products, - sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith. 4. The following are not covered by this Directive: - the labelling of medicinal products and the accompanying package leaflets, which are subject to the provisions of Directive 92/27/EEC; - correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product; - factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims; - statements relating to human health or diseases, provided there is no reference, even indirect, to medicinal products. Article 2 1. Member States shall prohibit any advertising of a medicinal product in respect of which a marketing authorization has not been granted in accordance with Community law. 2. All parts of the advertising of a medicinal product must comply with the particulars listed in the summary of product characteristics. 3. The advertising of a medicinal product: - shall encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties, - shall not be misleading. CHAPTER II Advertising to the general public Article 3 1. Member States shall prohibit the advertising to the general public of medicinal products which: - are available on medical prescription only, in accordance with Directive 92/26/EEC(8) , - contain psychotropic or narcotic substances, within the meaning of the international conventions, - may not be advertised to the general public in accordance with paragraph 2. 2. Medicinal products may be advertised to the general public which, by virtue of their composition and purpose, are intended and designed for use without the invervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary. Member States shall prohibit the mentioning in advertising to the general public of therapeutic indications such as: - tuberculosis, - sexually transmitted diseases, - other serious infectious diseases, - cancer and other tumoral diseases, - chronic insomnia, - diabetes and other metabolic illnesses. 3. Member States shall also be able to ban on their territory advertising to the general public of medicinal products the cost of which may be reimbursed. 4. The prohibition referred to in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States. 5. The prohibition referred to in paragraph 1 shall apply without prejudice to Articles 2, 3 and 14 of Directive 89/552/EEC. 6. Member States shall prohibit the direct distribution of medicinal products to the public by the industry for promotional purposes; they may, however, authorize such distribution in special cases for other purposes. Article 4 1. Without prejudice to Article 3, all advertising to the general public of a medicinal product shall: (a) be set out in such a way that it is clear that the message is an advertisement and that the product is clearly identified as a medicinal product; (b) include the following minimum information: - the name of the medicinal product, as well as the common name if the medicinal product contains only one active ingredient, - the information necessary for correct use of the medicinal product, - an express, legible invitation to read carefully the instructions on the package leaflet or on the outer packaging, according to the case. 2. Member States may decide that the advertising of a medicinal product to the general public may, notwithstanding paragraph 1, include only the name of the medicinal product if it is intended solely as a reminder. Article 5 The advertising of a medicinal product to the general public shall not contain any material which: (a) gives the impression that a medical consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by mail; (b) suggests that the effects of taking the medicine are guaranteed, are unaccompanied by side effects or are better than, or equivalent to, those of another treatment or medicinal product; (c) suggests that the health of the subject can be enhanced by taking the medicine; (d) suggests that the health of the subject could be affected by not taking the medicine; this prohibition shall not apply to the vaccination campaigns referred to in Article 3 (4); (e) is directed exclusively or principally at children; (f) refers to a recommendation by scientists, health professionals or persons who are neither of the foregoing but who, because of their celebrity, could encourage the consumption of medicinal products; (g) suggests that the medicinal product is a foodstuff, cosmetic or other consumer product; (h) suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural; (i) could, by a description or detailed representation of a case history, lead to erroneous self diagnosis; (j) refers, in improper, alarming or misleading terms, to claims of recovery; (k) uses, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body or parts thereof; (l) mentions that the medicinal product has been granted a marketing authorization. CHAPTER III Advertising to health professionals Article 6 1. Any advertising of a medicinal product to persons qualified to prescribe or supply such products shall include: - essential information compatible with the summary of product characteristics; - the supply classification of the medicinal product. Member States may also require such advertising to include the selling price or indicative price of the various presentations and the conditions for reimbursement by social security bodies. 2. Member States may decide that the advertising of a medicinal product to persons qualified to prescribe or supply such products may, notwithstanding paragraph 1, include only the name of the medicinal product, if it is intended solely as a reminder. Article 7 1. Any documentation relating to a medicinal product which is transmitted as part of the promotion of that product to persons qualified to prescribe or supply it shall include as a minimum the particulars listed in Article 6 (1) and shall state the date on which it was drawn up or last revised. 2. All the information contained in the documentation referred to in paragraph 1 shall be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product concerned. 3. Quotations as well as tables and other illustrative matter taken from medical journals or other scientific works for use in the documentation referred to in paragraph 1 shall be faithfully reproduced and the precise sources indicated. Article 8 1. Medical sales representatives shall be given adequate training by the firm which employs them and shall have sufficient scientific knowledge to be able to provide information which is precise and as complete as possible about the medicinal products which they promote. 2. During each visit, medical sales representatives shall give the persons visited, or have available for them, summaries of the product characteristics of each medicinal product they present together, if the legislation of the Member State so permits, with details of the price and conditions for reimbursement referred to in Article 6 (1). 3. Medical sales representatives shall transmit to the scientific service referred to in Article 13 (1) any information about the use of the medicinal products they advertise, with particular reference to any adverse reactions reported to them by the persons they visit. Article 9 1. Where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine or pharmacy. 2. Hospitality at sales promotion must always be reasonable in level and secondary to the main purpose of the meeting and must not be extended to other than health professionals. 3. Persons qualified to prescribe or supply medicinal products shall not solicit or accept any inducement prohibited under paragraph 1 or contrary to paragraph 2. 4. Existing measures or trade practices in Member States relating to prices, margins and discounts shall not be affected by this Article. Article 10 The provisions of Article 9 (1) shall not prevent hospitality being offered, directly or indirectly, at events for purely professional and scientific purposes; such hospitality must always be reasonable in level and remain subordinate to the main scientific objective of the meeting; it must not be extended to persons other than health professionals. Article 11 1. Free samples shall be provided on an exceptional basis only to persons qualified to prescribe them and on the following conditions: (a) a limited number of samples for each medicinal product each year on prescription; (b) any supply of samples must be in response to a written request, signed and dated, from the recipient; (c) those supplying samples must maintain an adequate system of control and accountability; (d) each sample shall be identical with the smallest presentation on the market; (e) each sample shall be marked free medical sample - not for resale or bear another legend of analogous meaning; (f) each sample shall be accompanied by a copy of the summary of product characteristics; (g) no samples of medicinal products containing psychotropic or narcotic substances within the meaning of international conventions may be supplied. 2. Member States may also place further restrictions on the distribution of samples of certain medicinal products. CHAPTER IV Monitoring of advertising Article 12 1. Member States shall ensure that there are adequate and effective methods to monitor the advertising of medicinal products. Such methods, which may be based on a system of prior vetting, shall in any event include legal provisions under which persons or organizations regarded under national law as having a legitimate interest in prohibiting any advertisement inconsistent with this Directive may take legal action against such advertisement, or bring such advertisement before an administrative authority competent either to decide on complaints or to initiate appropriate legal proceedings. 2. Under the legal provisions referred to in paragraph 1, Member States shall confer upon the courts or administrative authorities powers enabling them, in cases where they deem such measures to be necessary taking into account all the interests involved and in particular the public interest: - to order the cessation of, or to institute appropriate legal proceedings for an order for the cessation of, misleading advertising, or - if misleading advertising has not yet been published but publication is imminent, to order the prohibition of, or to institute appropriate legal proceedings for an order for the prohibition of, such publication, even without proof of actual loss or damage or of intention or negligence on the part of the advertiser. Member States shall also make provision for the measures referred to in the first subparagraph to be taken under an accelerated procedure: - either with interim effect, or - with definitive effect, on the understanding that it is for each Member State to decide which of the two options to select. Furthermore, Member States may confer upon the courts or administrative authorities powers enabling them, with a view to eliminating the continuing effects of misleading advertising the cessation of which has been ordered by a final decision: - to require publication of that decision in full or in part and in such form as they deem adequate, - to require in addition the publication of a corrective statement. 3. Under the legal provisions referred to in paragraph 1, Member States shall ensure that any decision taken in accordance with paragraph 2 shall state in detail the reasons on which it is based and shall be communicated in writing to the person concerned, mentioning the redress available at law and the time limit allowed for access to such redress. 4. This Article shall not exclude the voluntary control of advertising of medicinal products by self-regulatory bodies and recourse to such bodies, if proceedings before such bodies are possible in addition to the judicial or administrative proceedings referred to in paragraph 1. Article 13 1. The marketing authorization holder shall establish within his undertaking a scientific service in charge of information about the medicinal products which he places on the market. 2. The person responsible for placing the product on the market shall: - keep available for, or communicate to, the authorities or bodies responsible for monitoring advertising of medicinal products a sample of all advertisements emanating from his undertaking together with a statement indicating the persons to whom it is addressed, the method of dissemination and the date of first dissemination, - ensure that advertising of medicinal products by his undertaking conforms to the requirements of this Directive, - verify that medical sales representatives employed by his undertaking have been adequately trained and fulfill the obligations imposed upon them by Article 8 (2) and (3), - supply the authorities or bodies responsible for monitoring advertising of medicinal products with the information and assistance they require to carry out their responsibilities, - ensure that the decisions taken by the authorities or bodies responsible for monitoring advertising of medicinal products are immediately and fully complied with. Article 14 Member States shall take the appropriate measures to ensure that all the provisions of this Directive are applied in full and shall determine in particular what penalties shall be imposed should the provisions adopted in the execution of this Directive be infringed. Article 15 1. Member States shall take the measures necessary in order to comply with this Directive with effect from 1 January 1993. They shall forthwith inform the Commission thereof. 2. When Member States adopt the said measures, such measures shall contain a reference to this Directive or 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. Article 16 This Directive is addressed to the Member States.

31992L0025

1992

Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use 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 it is important to adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market is to comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas the wholesale distribution of medicinal products is at present subject to different provisions in the various Member States; whereas many operations involving the wholesale distribution of medicinal products for human use may cover several Member States simultaneously; Whereas it is necessary to exercise control over the entire chain of distribution of medicinal products, from their manufacture or import into the Community through to supply to the public, so as to guarantee that such products are stored, transported and handled in suitable conditions; whereas the requirements which must be adopted for this purpose will considerably facilitate the withdrawal of defective products from the market and allow more effective efforts against counterfeit products; Whereas any person involved in the wholesale distribution of medicinal products should be in possession of a special authorization; whereas pharmacists and persons authorized to supply medicinal products directly to the public, and who confine themselves to this activity, should be exempt from obtaining this authorization; whereas it is however necessary, in order to control the complete chain of distribution of medicinal products, that pharmacists and persons authorized to supply medicinal products to the public keep records showing transactions in products received; Whereas authorization must be subject to certain essential conditions and it is the responsibility of the Member State concerned to ensure that such conditions are met; whereas each Member State must recognize authorizations granted by other Member States; Whereas certain Member States impose on wholesalers who supply medicinal products to pharmacists and on persons authorized to supply medicinal products to the public certain public service obligations; whereas those Member States must be able to continue to impose those obligations on wholesalers established within their territory; whereas they must also be able to impose them on wholesalers in other Member States on condition that they do not impose any obligation more stringent than those which they impose on their own wholesalers and provided that such obligations may be regarded as warranted on grounds of public health protection and are proportionate in relation to the objective of such protection, Article 1 1. This Directive covers the wholesale distribution in the Community of medicinal products for human use to which Chapters II to V of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(4) apply. 2. For the purposes of this Directive: - wholesale distribution of medicinal products shall mean all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public; such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned, - public service obligation shall mean the obligation placed on wholesalers to guarantee permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question. Article 2 Without prejudice to Article 3 of Directive 65/65/EEC, Member States shall take all appropriate action to ensure that only medicinal products in respect of which a marketing authorization has been granted in accordance with Community law are distributed on their territory. Article 3 1. Member States shall take all appropriate measures to ensure that the wholesale distribution of medicinal products is subject to the possession of an authorization to engage in activity as a wholesaler in medicinal products, stating the place for which it is valid. 2. Where persons authorized or entitled to supply medicinal products to the public may also, under national law, engage in wholesale business, such persons shall be subject to the authorization provided for in paragraph 1. 3. Possession of an authorization, as mentioned in Article 16 of Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products(5) , shall include authorization to distribute by wholesale the medicinal products covered by that authorization. Possession of an authorization to engage in activity as a wholesaler in medicinal products shall not give dispensation from the obligation to possess a manufacturing authorization and to comply with the conditions set out in that respect, even where the manufacturing or import business is secondary. 4. At the request of the Commission or any Member State, Member States shall supply all appropriate information concerning the individual authorizations which they have granted under paragraph 1. 5. Checks on the persons and establishments authorized to engage in the activity of wholesaler in medicinal products and the inspection of their premises shall be carried out under the responsibility of the Member State which granted the authorization. 6. The Member State which granted the authorization referred to in paragraph 1 shall suspend or revoke that authorization if the conditions of authorization cease to be met. It shall forthwith inform the other Member States and the Commission thereof. 7. Should a Member State consider that, in respect of a person holding an authorization granted by another Member State under the terms of paragraph 1, the conditions of authorization are not, or are no longer, met, it shall forthwith inform the Commission and the other Member State involved. The latter shall take the measures necessary and shall inform the Commission and the first Member State of the decisions taken and the reasons for those decisions. Article 4 1. Member States shall ensure that the time taken for the procedure for examining the application for the authorization referred to in Article 3 (1) does not exceed 90 days from the day on which the competent authority of the Member State concerned receives the application. The competent authority may, if need be, require the applicant to supply all necessary information concerning the conditions of authorization. Where the authority exercises this option, the period laid down in this paragraph shall be suspended until the requisite additional data have been supplied. 2. All decisions to refuse, suspend or revoke the authorization referred to in Article 3 (1) shall state in detail the reasons on which they are based. A decision shall be notified to the party concerned, who shall at the same time be informed of the redress available to him under the laws in force and of the time limit allowed for access to such redress. Article 5 In order to obtain the authorization referred to in Article 3 (1), applicants must fulfil the following minimum requirements: (a) they must have suitable and adequate premises, installations and equipment so as to ensure proper conservation and distribution of the medicinal products; (b) they must have staff, and in particular a qualified person designated as responsible, meeting the conditions provided for by the legislation of the Member State concerned; (c) they must undertake to fulfil the obligations incumbent on them under the terms of Article 6. Article 6 Holders of the authorization referred to in Article 3 (1) must fulfil the following minimum requirements: (a) they must make the premises, installations and equipment referred to in Article 5 (a) accessible at all times to the persons responsible for inspecting them; (b) they must obtain their supplies of medicinal products only from persons who are themselves in possession of the authorization referred to in Article 3 (1) or who are exempt from obtaining such authorization under the terms of Article 3 (3); (c) they must supply medicinal products only to persons who are themselves in possession of the authorization referred to in Article 3 (1) or who are authorized or entitled to supply medicinal products to the public in the Member State concerned; (d) they must have an emergency plan which ensures effective implementation of any recall from the market ordered by the competent authorities or carried out in cooperation with the manufacturer or holder of the marketing authorization for the product concerned; (e) they must keep records either in the form of purchase/sales invoices, or on computer, or in any other form giving for any transaction in medicinal products received or dispatched at least the following information: - date, - name of the medicinal product, - quantity received or supplied, - name and address of the supplier or consignee, as appropriate; (f) they must keep the records referred to under (e) available to the competent authorities, for inspection purposes, for a period of five years; (g) they must comply with the principles and guidelines of good distribution practice for medicinal products as laid down in Article 10. Article 7 With regard to the supply of medicinal products to pharmacists and persons authorized or entitled to supply medicinal products to the public, Member States shall not impose upon the holder of an authorization referred to in Article 3 (1) which has been granted by another Member State, any obligation, in particular public service obligations, more stringent than those they impose on persons whom they have themselves authorized to engage in equivalent activities. The said obligations should, moreover, be justified, in keeping with the Treaty, on grounds of public health protection and be proportionate in relation to the objective of such protection. Article 8 For all supplies of medicinal products to a person authorized or entitled to supply medicinal products to the public in the Member State concerned, the authorized wholesaler must enclose a document that makes it possible to ascertain: - the date, - the name and pharmaceutical form of the medicinal product, - the quantity supplied, - the name and address of the supplier and consignor. Member States shall take all appropriate measures to ensure that persons authorized or entitled to supply medicinal products to the public are able to provide information that makes it possible to trace the distribution path of every medicinal product. Article 9 The provisions of this Directive shall not prevent the application of more stringent requirements laid down by Member States in respect of the wholesale distribution of: - narcotic or psychotropic substances within their territory, - medicinal products derived from blood governed by Directive 89/381/EEC(6) , - immunological medicinal products governed by Directive 89/342/EEC(7) , - radiopharmaceuticals governed by Directive 89/343/ EEC(8) . Article 10 The Commission shall publish guidelines on good distribution practice. To this end it shall consult the Committee for Proprietary Medicinal Products and the Pharmaceutical Committee. Article 11 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1993. They shall forthwith inform the Commission thereof. 2. When these measures are adopted by the Member States, 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. Article 12 This Directive is addressed to the Member States.

31992L0022

1992

Council Directive 92/22/EEC of 31 March 1992 on safety glazing and glazing materials on motor vehicles and their trailers 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 measures should be adopted with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas the total-harmonization method will be essential in order fully to achieve the single market; Whereas this method will have to be used at the time of the revision of the entire EEC type-approval procedure, taking account of the spirit of the Council resolution of 7 May 1985 concerning a new approach to the question of technical harmonization and standardization; Whereas the requirements relating to safety glazing differ from one Member State to another; whereas it is consequently necessary for the same requirements to be adopted by all of the Member States, either in addition to or in place of the existing rules, in order, in particular, to permit implementation, for each type of vehicle, of the EEC type-approval procedure covered by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (4), as last amended by Directive 87/403/EEC (5); Whereas any rules on safety glazing shall contain not only requirements relating to its structure but also to its fitting to vehicles; Whereas by means of a harmonized procedure for the component type-approval of safety glazing, each Member State shall be able to confirm compliance with common requirements relating to manufacture and testing and to inform the other Member States of any such confirmation by forwarding a copy of the component type-approval certificate drawn up for each type of safety glazing; whereas the affixing of an EEC component type-approval mark to any type of safety glazing that conforme to the type that has been component type-approved means that the official testing of that type of glazing in other Member States is no longer justified; Whereas the safety aspect of windscreens is especially important since, more than in the case of other types of glazing, they are likely to be subjected to violent impact either as a result of collisions or where there are external shocks and can thus be the cause of serious bodily injury; whereas, while aiming at the approximation of the laws of the Member States, the differences between which raise barriers to trade, the solution to be adopted must take account of the safety requirements of road traffic and the need to improve same, Article 1 1. Member States shall type-approve any type of safety glazing within the scope defined in Section 1 of Annex I that meets the structural and testing requirements. 2. Member States shall grant whole-vehicle type approval to any vehicle that complies with the fitting requirements laid down in Annex III. 3. The Member State which has granted EEC component type-approval shall take the necessary measures to verify, insofar as is necessary and if need be in cooperation with the competent authorities of the other Member States, that production models conform to the approved type. Article 2 All applications for EEC component type-approval shall be made by the manufacturer or his authorized representative in a Member State. That Member State shall issue to the manufacturer or his authorized representative an EEC component type-approval mark in compliance with items 4.4 to 4.7 of Annex II for each type of safety glazing that it type-approves in pursuance of Article 1. Member States shall take all necessary measures to prevent the use of any marks liable to create confusion between items of safety glazing that have already been component type-approved pursuant to Article 1. Article 3 The competent authorities in each Member State shall, within one month, send to the competent authorities of the other Member States a copy of the component type-approval certificate drawn up for each type of safety glazing and with regard to its fitting, for each type of vehicle to which they grant whole-vehicle type-approval. Article 4 No Member State may prohibit the marketing or use of safety glazing on grounds relating to its construction where that glazing bears the EEC component type-approval mark. Article 5 1. If the Member State which has granted EEC component type-approval finds that a number of items of safety glazing bearing the same component type-approval mark do not conform to the approved type, it shall take the necessary measures to ensure that production models do so conform. The competent authorities of that State shall advise those of the other Member States of the measures taken, which may, where necessary, extend to withdrawal of EEC component type-approval. The said authorities shall take like measures if they are informed by the competent authorities of another Member State of such failure to conform. 2. The competent authorities of the Member States shall inform each other, within one month, of any withdrawal of EEC component type-approval, and of the reasons for such a measure. 3. If the Member State which has granted EEC component type-approval disputes the failure to conform notified to it, the Member States concerned shall endeavour to settle the dispute. The Community shall be kept informed and shall, where necessary, hold appropriate consultations for the purpose of reaching a settlement. Article 6 Any decision taken pursuant to the provisions adopted in implementation of this Directive to refuse or withdraw component type-approval, or prohibit sale and use, shall state in detail the reasons on which it is based. Such decision shall be notified to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member States and of the time-limits allowed for the exercise of such remedies. Article 7 No Member State may refuse EEC whole-vehicle type-approval or national type-approval of a type of vehicle, or refuse or prohibit the sale, entry into service or use of a vehicle, on grounds relating to its safety glazing if this bears the EEC component type-approval mark and if it has been fitted in accordance with the requirements set out in Annex III. Article 8 For the purposes of this Directive, 'vehicle' means any motor vehicle intended for use on the road, having at least four wheels and a maximum design speed exceeding 25 km/h as well as its trailer, with the exception of vehicles which run on rails, agricultural and forestry tractors or machinery, and construction plant and equipment. The international classification of these vehicles shall be as set out in Note (b) of Annex I to Directive 70/156/EEC. Article 9 Any amendments necessary to adapt the requirements of the Annexes to technical progress shall be adopted in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC. Article 10 1. Member States shall adopt and publish the provisions necessary to comply with this Directive before 1 July 1992 and shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. They shall apply these provisions from 1 October 1992. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 11 This Directive is addressed to the Member States.

31992L0031

1992

Council Directive 92/31/EEC of 28 April 1992 amending Directive 89/336/EEC on the approximation of the laws of the Member States relating to electromagnetic compatibility 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 Directive 89/336/EEC (4) provides for complete harmonization relating to electromagnetic compatibility; Whereas a uniform application of that Directive requires the availability of harmonized standards; whereas these standards will not be available by the date of application of that Directive; Whereas that Directive has not provided for an adequate transitional period during which it would be permitted to place on the market apparatus manufactured in accordance with national regulations applicable before the date of application of the said Directive; Whereas manufacturers must have the time needed to allow apparatus in stock to be marketed; Whereas Directive 89/336/EEC should accordingly be amended, Article 1 Directive 89/336/EEC is hereby amended as follows: 1. Article 10 (3) shall be deleted. 2. Article 12 (1) shall be supplemented by the following paragraph: 'However, Member States shall, for the period up to 31 December 1995, authorize the placing on the market and/or the putting into service of apparatus referred to in this Directive conforming to the national regulations in force in their territory on 30 June 1992.' Article 2 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than three months after its adoption. 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. Member States shall apply these provisions not later than six months after the adoption of this Directive. 2. Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field governed by this Directive. Article 3 This Directive is addressed to the Member States.

31992L0033

1992

Council Directive 92/33/EEC of 28 April 1992 on the marketing of vegetable propagating and planting material, other than seed Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 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 the production of vegetables occupies an important place in the agriculture of the Community; Whereas satisfactory results in the cultivation of vegetables depend to a large extent on the quality and plant health not only of the seed already covered by Council Directive 70/458/EEC of 29 September 1970 on the marketing of vegetable seed (4) but also of the vegetable planting material used for their propagation; whereas certain Member States have in consequence introduced rules intended to guarantee the quality and plant health of the propagating and planting material of vegetable plants placed on the market; Whereas the different treatment accorded to vegetable propagating and planting material in different Member States is likely to create barriers to trade and thus hinder the free movement of these products within the Community; whereas, with a view to achieving the internal market, these barriers should be removed by adopting Community provisions to replace those laid down by the Member States; Whereas the establishment of harmonized conditions at Community level will ensure that purchasers throughout the Community receive vegetable propagating and planting material which is healthy and of good quality; Whereas, in so far as they relate to plant health, such harmonized conditions must be consistent with Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Member States of organisms harmful to plants or plant products (5); Whereas, without prejudice to the plant-health provisions of Directive 77/93/EEC, it is not appropriate to apply the Community rules on the marketing of vegetable propagating and planting material when it is shown that such products are intended for export to third countries, as the rules applicable there may be different from those contained in this Directive; Whereas the determination of plant-health and quality standards for each genus and species of vegetable plant requires lengthy and detailed technical and scientific consideration; whereas a procedure should accordingly be established for that purpose; Whereas in the first instance it is the responsibility of the suppliers of vegetable propagating and planting material to ensure that their products fulfil the conditions laid down in this Directive; Whereas the competent authorities of the Member States must, when carrying out controls and inspections, ensure that suppliers fulfil those conditions; Whereas Community control measures should be introduced to ensure the uniform application in all the Member States of the standards laid down in this Directive; Whereas it is in the interests of the purchasers of vegetable propagating and planting materials that the name of varieties be known and their identity safeguarded; Whereas, to this end, provision should be made as far as possible for the application of the rules on the varietal aspect as established with respect to the marketing of vegetable seed; Whereas, in order to ensure the identity and orderly marketing of vegetable propagating and planting material, Community rules must be laid down concerning the separation of lots, and marking; whereas the labels used should give the particulars needed both for official control and for the information of the user; Whereas rules should be established permitting, in cases of temporary supply difficulties, the marketing of vegetable propagating and planting material subject to requirements less stringent than those contained in this Directive; Whereas, as a first step towards harmonized conditions, Member States should be prohibited in the case of the genera and species referred to in Annex II, for which fact-sheets will be drawn up, from imposing new conditions or restrictions on the marketing, other than those provided for in this Directive; Whereas provisions should be made for authorizing the marketing within the Community of vegetable propagating and planting material produced in third countries, provided always that it affords the same assurances as vegetable propagating and planting material produced in the Community and complying with Community rules; Whereas, in order to harmonize technical methods of examination used in the Member States and to compare propagating and planting material and vegetable plants produced in the Community with that produced in third countries, comparative trials should be carried out to check compliance of such products with the requirements of this Directive; Whereas, in order to facilitate the effective operation of this Directive, the Commission should be entrusted with the task of adopting measures for its implementation and for the amendment of its Annex, and to provide a procedure to that end involving close cooperation between the Commission and the Member States within a Standing Committee on Seeds and Propagating Materials, Agriculture, Horticulture and Forestry, Article 1 1. This Directive applies to the marketing of vegetable propagating and planting materials, other than seeds, within the Community. 2. Articles 2 to 20 and 24 shall apply to the genera and species, and their hybrids, listed in Annex II. Rootstocks and other parts of plants of other genera or species or their hybrids shall also be subject to the abovementioned Articles if material of one of the said genera or species, or of their hybrids, is, or has to be, grafted on to them. 3. Amendments to the list of genera and species in Annex II shall be adopted in accordance with the procedure laid down in Article 22. Article 2 This Directive shall not apply to propagating or planting material shown to be intended for export to third countries, if properly identified as such and kept sufficiently isolated, without prejudice to the health rules laid down in Directive 77/93/EEC. Implementing measures for the first subparagraph, with particular reference to identification and isolation, shall be adopted in accordance with the procedure laid down in Article 21. Article 3 For the purposes of this Directive, the following definitions shall apply: (a) propagating material: parts of plants and all plant material, including rootstocks intended for the propagation and production of vegetables; (b) planting material: entire plants and parts of plants including, for grafted plants, the grafted components, intended for planting for the production of vegetables; (c) supplier: any natural or legal person carrying out professionally at least one of the following activities with regard to vegetable propagating and planting material: reproducing, producing, preserving and/or treating and marketing; (d) marketing: the holding available or in stock, displaying or offering for sale, selling and/or delivering to another person, in whatever form, of propagating or planting material; (e) responsible official body: (i) the sole and central authority, established or designated by the Member State under the supervision of the national government and responsible for questions concerning quality; (ii) any State authority established: - either at national level, - or at regional level, under the supervison of the national authorities within the limits set by the national legislation of the Member State concerned. The bodies referred to in (i) and (ii) may, in accordance with their national legislation, delegate the tasks provided for in this Directive to be accomplished under their authority and supervision to any legal person, whether governed by public or private law, which, under its officially approved constitution, is charged exclusively with specific public functions, provided that such person, and its members, have no personal interest in the outcome of the measures they take. The Member States shall ensure that there is close cooperation between the bodies referred to in (ii) and those referred to in (i). Moreover, in accordance with the procedure laid down in Article 21, another legal person established on behalf of any body referred to in (i) and (ii) and acting under the authority and supervision of such body may be approved, provided that such person has no personal interest in the outcome of the measures it takes. The Member States shall notify the Commission of their responsible official bodies. The Commission shall forward that information to the other Member States; (f) official measures: measures taken by the responsible official body; (g) official inspection: inspection carried out by the responsible official body; (h) official statement: statement issued by, or under the responsibility of, the responsible official body; (i) lot: a number of units of a single commodity, identifiable by its homogeneity of composition and origin; (j) laboratory: a public or private law entity carrying out analysis and proper diagnosis, enabling the producer to monitor production quality. Article 4 In accordance with the procedure laid down in Article 22, a schedule shall be established in Annex I for each genus and species referred to in Annex II and for rootstocks of other genera and species if material of the genus or species is, or has to be, grafted on to them, with a reference to the plant-health conditions laid down in Directive 77/93/EEC applying to the genus and/or species concerned, and laying down: (i) the conditions with which vegetable planting material must comply, in particular those relating to the quality and purity of the crop and, where appropriate varietal characteristics. These requirements shall be added to Annex I, Part A; (ii) the conditions with which propagating material must comply, in particular those relating to the propagation system applied, the purity of the growing crop and, where appropriate, the varietal characteristics. These conditions will be set out in Annex I, Part B. Article 5 1. Member States shall ensure that suppliers take all the necessary measures to guarantee compliance with the standards set by this Directive at all stages of the production and marketing of vegetable propagating and planting material. 2. For the purposes of paragraph 1, the said suppliers shall either carry out themselves, or have carried out by an accredited supplier or a responsible official body, checks based on the following principles: - identification of critical points in their production process on the basis of the production methods used, - establishment and implementation of methods for monitoring and checking the critical points referred to in the first indent, - taking samples for analysis in a laboratory accredited by the responsible official body for the purpose of checking compliance with the standards established by this Directive, - keeping a written record or a record registered in an indelible fashion of the data referred to in the first, second and third indents, as well as records on production and marketing of propagating and planting material, to be held at the disposal of the responsible official body. These documents and records shall be kept for a period of at least one year. However, suppliers whose activity in this connection is confined merely to the distribution of vegetable propagating and planting material produced and packaged on premises other than their own shall be required only to keep a written record or a record registered in an indelible fashion of the buying and selling and/or delivery of such products. This paragraph shall not apply to suppliers whose activity in this connection is confined to the supply of small quantities of vegetable propagating and planting material to non-professional final consumers. 3. If the result of their own checks or any information at the disposal of the suppliers referred to in paragraph 1 reveals the presence of one or more of the harmful organisms referred to in Directive 77/93/EEC or in quantities greater than those normally allowed for in order to meet the standards, or of those specified in the relevant schedules established pursuant to Article 4, the suppliers shall immediately report this to the responsible official body and shall take the measures indicated by that body or any other measure necessary to reduce the risk of such harmful organisms from spreading. The supplier shall keep records of all occurrences of harmful organisms on his premises and of all measures taken in relation to such occurrences. 4. Detailed rules for the application of the second subparagraph of paragraph 2 shall be established in accordance with the produce laid down in Article 21. Article 6 1. The responsible official body shall accredit suppliers once it has verified that their production methods and establishments meet the requirements of this Directive with regard to the nature of the activities they carry out. Accreditation must be renewed if a supplier decides to carry out activities other than those for which he has received accreditation. 2. The responsible official body shall accredit laboratories once it has verified that these laboratories, their methods and their establishments meet the requirements of this Directive to be specified according to the procedure laid down in Article 21, with regard to the testing activities they carry out. Accreditation must be renewed if a laboratory decides to carry out activities other than those for which it has received accreditation. 3. The responsible official body shall take the necessary measures if the requirements referred to in paragraphs 1 and 2 cease to be met. To this end, it shall take particular account of the conclusions of any check carried out in accordance with Article 7. 4. The supervision and monitoring of suppliers, establishments and laboratories shall be carried out regularly by or under the responsibility of the responsible official body, which shall at all times have free access to all parts of establishments, in order to ensure compliance with the requirements of this Directive. Implementing measures concerning supervision and monitoring shall be adopted, as necessary, in accordance with the procedure laid down in Article 21. If such supervision and monitoring reveal that the requirements of this Directive are not being met, the responsible official body shall take appropriate action. Article 7 1. Commission experts may in cooperation with the responsible official bodies of the Member States, make on-the-spot checks in so far as this is necessary to ensure uniform application of this Directive and in particular to verify whether suppliers are in effect complying with the requirements of this Directive. A Member State in whose territory a check is being carried out shall give all necessary assistance to the experts in carrying out their duties. The Commission shall inform the Member States of the result of the investigations. 2. Detailed rules for the application of paragraph 1 shall be adopted in accordance with the procedure laid down in Article 21. Article 8 1. Vegetable propagating and planting material may be marketed only by accredited suppliers and provided they meet the requirements laid down in the schedule referred to in Article 4. 2. Without prejudice to the provisions of Directive 77/93/EEC, paragraph 1 shall not apply to vegetable propagating and planting material intended for: (a) trials or scientific purposes; or (b) selection work; or (c) measures aimed at preserving genetic diversity. Detailed rules for the application of points (a) and (b) shall be adopted as necessary in accordance with the procedure laid down in Article 21. Detailed rules for the application of point (c) shall be adopted preferably before 1 January 1993, in accordance with the same procedure. Article 9 1. Without prejudice to Article 2, vegetable propagating and planting material which belongs to genera or species listed in Annex II and is also covered by Directive 70/458/EEC shall not be marketed within the Community unless it belongs to a variety accepted in accordance with Directive 70/458/EEC. 2. Without prejudice to Article 2 and paragraphs 3 and 4 of this Article, vegetable propagating and planting material which belongs to genera or species listed in Annex II but which is not covered by Directive 70/458/EEC shall not be marketed within the Community unless it belongs to a variety officially accepted in at least one Member State. The provisions laid down in Articles 4, 5 and 10 (3) of Directive 70/458/EEC shall apply to the conditions for acceptance. Articles 3 (2) and (4), 6, 7, 8, 10 (1), (2) and (4) and 11 to 15 of the said Directive shall apply mutatis mutandis to the procedures and formalities for acceptance and maintenance production. The results of unofficial tests and practical information gathered in the course of growing may be taken into consideration in each instance. 3. Member States shall take all necessary steps to ensure that the official acceptance of varieties belonging to the genera or species referred to in paragraph 2 which was granted prior to 1 January 1993 in accordance with principles other than those laid down in Directive 70/458/EEC or on the basis of the fact that their material was marketed in their territory before that date expires on 30 June 1998 at the latest, unless the varieties in question have been accepted in accordance with paragraph 1 on the date. 4. Varieties officially accepted in accordance with paragraphs 2 and 3 shall be entered in the Common Catalogue of Varieties of Vegetable Species referred to in Article 17 of Directive 70/458/EEC. Articles 16 (2) and (3), 17, 18 and 19 shall apply mutatis mutandis. The publication in question shall designate the varieties accepted pursuant to paragraph 3 with a specific reference. Article 10 1. While growing and during lifting or removal from the parent material, vegetable propagating and planting material shall be kept in separate lots. 2. If vegetable propagating and planting material of different origins is put together or mixed during packaging, storage, transport or at delivery, the supplier shall keep records including the following data: composition of the lot and origin of the individual components. 3. Member States shall ensure compliance with the requirements of paragraphs 1 and 2 by carrying out official inspections. Article 11 1. Without prejudice to Article 10 (2), vegetable propagating and planting material shall be marketed only in sufficiently homogeneous lots and if they are recognized as complying with this Directive and are accompanied by a document made out by the supplier in accordance with the conditions laid down in the schedule established pursuant to Article 4. If an official statement appears on this document, it shall be clearly separated from all other contents of the document. Requirements on vegetable propagating and planting material for labelling and/or sealing and packaging shall be set out in the schedule referred to in Article 4. 2. In the case of supply by the retailer of vegetable propagating and planting material to a non-professional final consumer, requirements on labelling may be confined to appropriate product information. Article 12 Member States may exempt: - from the application of Article 11, small producers all of whose production and sales of vegetable propagating and planting material is intended for final use by persons on the local market who are not professionally involved in plant production ('local circulation'). - from the controls and offical inspection provided for in Article 18, the local circulation of vegetable propagating and planting materials produced by such exempt persons. In accordance with the procedure laid down in Article 21, implementing measures relating to other requirements concerning the exemptions referred to in the first and second indents above, in particular as regards the concepts of 'small producers' and 'local market', and to the relevant procedures, shall be adopted. Article 13 In the event of temporary difficulties in the supply of vegetable propagating and planting material satisfying the requirements of this Directive, measures may be adopted, in accordance with the procedure laid down in Article 21, concerning the marketing of vegetable propagating and planting material meeting less stringent requirements, without prejudice to the plant-health rules laid down in Directive 77/93/EEC. Article 14 1. The marketing of vegetable propagating and planting material which complies with the requirements and conditions of this Directive shall be subject to no restrictions as regards supplier, plant health, growing medium and inspection arrangements other than those laid down in this Directive. 2. The marketing of vegetable propagating and planting material whose variety is entered in the Common Catalogue of Varieties of Vegetable Species shall not be subject to any restriction as regards variety other than those laid down or referred to in this Directive. Article 15 As regards the products referred to in Annex II, Member States shall refrain from imposing more stringent conditions or marketing restrictions other than the conditions laid down in the schedules referred to in Article 4 or, failing that, those existing on the date of adoption of this Directive. Article 16 1. In accordance with the procedure laid down in Article 21, it shall be decided whether vegetable propagating and planting material produced in a third country and affording the same guarantees as regards obligations on the supplier, identity, characteristics, plant health, growing medium, packaging, inspection arrangements, marking and sealing, is equivalent in all these respects to vegetable propagating and planting material produced in the Community and complying with the requirements and conditions of this Directive. 2. Pending the decision referred to in paragraph 1, Member States may, until 1 January 1993, and without prejudice to the provisions of Directive 77/93/EEC, apply to the import of vegetable propagating and planting material from third countries conditions at least equivalent to those laid down temporarily or permanently in the schedules referred to in Article 4. Where no such conditions are laid down in the said schedules, the import conditions must be at least equivalent to those applicable to production in the Member State concerned. In accordance with the procedure laid down in Article 21, the date referred to in the first subparagraph may, for the various third countries, be deferred pending the decision referred to in paragraph 1. Vegetable propagating and planting material imported by a Member State in accordance with a decision taken by that Member State pursuant to the first subparagraph shall be subject to no marketing restrictions in the other Member States as regards the matters referred to in paragraph 1. Article 17 Member States shall ensure that official inspection by sampling checks on propagating and planting material is carried out during production and marketing, with the aim of verifying compliance with the requirements and conditions of this Directive. Article 18 Detailed implementing procedures for the controls provided for in Article 5 and for the official inspection provided for in Articles 10 and 17, including sampling methods, shall be adopted, as necessary, in accordance with the procedure provided for in Article 21. Article 19 1. If, during the supervision and monitoring provided for in Article 6 (4), the official inspection provided for in Article 17, or the trials provided for in Article 20, it is found that vegetable propagating and planting material does not meet the requirements of this Directive, the responsible official body of the Member State shall take appropriate action to ensure that it does comply with the provisions of this Directive or, if that is not possible, to ban the marketing of that vegetable propagating and planting material in the Community. 2. If it is found that vegetable propagating and planting material marketed by a particular supplier does not comply with the requirements and conditions of this Directive, the Member State concerned shall ensure that appropriate measures are taken against that supplier. If the supplier is forbidden to market vegetable propagating and planting material, the Member State shall notify the Commission and the competent national authorities in the Member States. 3. Any measures taken under paragraph 2 shall be withdrawn as soon as it has been established with adequate certainty that the vegetable propagating and planting material intended for marketing by the supplier will, in future, comply with the requirements and conditions of this Directive. Article 20 1. Trials, or, where appropriate, tests shall be carried out in the Member States on samples to check that vegetable propagating and planting material complies with the requirements and conditions of this Directive, including those relating to plant health. The Commission may organize inspections of the trials by representatives of the Member States and of the Commission. 2. It may be decided in accordance with the procedure laid down in Article 21 that it is necessary to carry out Community trials for the same purpose as mentioned in paragraph 1. The Commission may organize inspections of Community trials by representatives of the Member States and of the Commission. 3. The trials or tests referred to in paragraphs 1 and 2 shall be used to harmonize technical methods of examination of vegetable propagating and planting material. Progress reports shall be made on the trials or tests and sent in confidence to the Member States and to the Commission. 4. The Commission shall ensure that, in appropriate cases, arrangements for coordinating, carrying out and inspecting the trials referred to in paragraphs 1 and 2, and assessing their results, are made within the Commitee set up by Article 21. When plant-health problems occur, the Commission shall notify the Standing Committee on Plant Health. If necessary, specific arrangements shall be adopted. Vegetable propagating and planting material produced in third countries shall be included in the trials. Article 21 1. The Commission shall be assisted by a committee, referred to as the 'Standing Committee on Agricultural, Horticultural and Forestry Seeds and Plants', chaired by the representative of the Commission. 2. The representative of the Commission 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. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. The Commission shall adopt measures which shall apply immediately. However, if these measures are not in accordance with the opinion of the committee, they shall be communicated by the Commission to the Council forthwith. In that event, the Commission may defer application of the measures which it had decided for a period of not more than one month from the date of such communication. The Council, acting by a qualified majority, may take a different decision within the time limit referred to in the previous paragraph. Article 22 1. The Commission shall be assisted by the Standing Committee on Seeds and Propagating Materials for Agriculture, Horticulture and Forestry, chaired by the representative of the Commission. 2. The representative of the Commission 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. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. The Commission shall adopt measures envisaged in accordance with the opinion of the committee. If 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 relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 23 Amendments to the schedules referred to in Article 4 and to the conditions and detailed rules adopted for the implementation of this Directive shall be adopted in accordance with the procedure laid down in Article 21. Article 24 1. Member States shall ensure that vegetable propagating and planting material produced in their territory and intended for marketing complies with the requirements of this Directive. 2. If it is found, during an official inspection, that vegetable propagating and planting material cannot, by reason of non-compliance with a condition relating to plant health, be marketed, the Member State concerned shall take appropriate official measures to eliminate any consequent plant-health risk. Article 25 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 31 December 1992. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods for making such reference shall be laid down by the Member States. 2. As far as Articles 5 to 11, 14, 15, 17, 19 and 24 are concerned, the date of application for each of the genera or species referred to in Annex II shall be fixed in accordance with the procedure laid down in Article 21, when the schedule referred to Article 4 is drawn up. Article 26 This Directive is addressed to the Member States.

31992L0034

1992

Council Directive 92/34/EEC of 28 April 1992 on the marketing of fruit plant propagating material and fruit plants intended for fruit production Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 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 fruit production occupies an important place in the agriculture of the Community; Whereas satisfactory results in the cultivation of fruit depend to a large extent on the quality and plant health of the material used for their propagation and of the fruit plants intended for fruit production; whereas certain Member States have in consequence introduced rules intended to guarantee the quality and plant health of the fruit plant propagating material and fruit plants placed on the market; Whereas the different treatment accorded to propagating material and fruit plants in different Member States is likely to create barriers to trade and thus hinder the free movement of these goods within the Community; whereas, with a view to achieving the internal market, these barriers should be removed, by adopting Community provisions to replace those laid down by the Member States; Whereas the establishment of harmonized conditions at Community level will ensure that purchasers throughout the Community receive propagating material and fruit plants which are healthy and of good quality; Whereas, so far as they relate to plant health, such harmonized conditions must be consistent with Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Member States of organisms harmful to plant or plant products (4); Whereas it is appropriate initially to establish Community rules for those genera and species of fruit plant which are of major economic importance in the Community, with a Community procedure for adding further genera and species later; Whereas, without prejudice to the plant health provisions of Directive 77/93/EEC, it is not appropriate to apply the Community rules on the marketing of propagating material and fruit plants when it is shown that such products are intended for export to third countries, as the rules applicable there may be different from those contained in this Directive; Whereas the determination of plant health and quality standards for each genus and species of fruit plant requires lengthy and detailed technical and scientific consideration; whereas a procedure should accordingly be established for that end; Whereas in the first instance it is the responsibility of the suppliers of propagating material and/or fruit plants to ensure that their products fulfil the conditions laid down in this Directive; Whereas the competent authorities of the Member States must, when carrying out controls and inspections, ensure that suppliers fulfil those conditions with regard to propagating material or fruit plants belonging to the CAC (Conformitas Agraria Communitatis) category; Whereas it is indispensable to provide for other categories of propagating material and fruit plants for which the said material and plants must be the subject of official certification; Whereas Community control measures should be introduced to ensure uniform application in all the Member States of the standards laid down in this Directive; Whereas it is consistent with current agricultural practice to require that certain propagating material and fruit plants are either officially examined, or are declared virus-free, meaning found free of all known viruses and virus-like pathogens, or again virus-tested, meaning found free of specific viruses and virus-like pathogens reducing the usefulness of the propagating material and fruit plants; Whereas it is in the interests of the purchasers of propagating materials and fruit plants that the names of varieties be known and that their identity be safeguarded; Whereas the objective stated above can best be achieved either through common knowledge of the variety or through the availability of a description drawn up and kept by the supplier; whereas in the latter case, however, the propagating material or fruit plants may not obtain access to the categories which are the subject of official certification; Whereas, in order to ensure the identity and orderly marketing of propagating material and fruit plants, Community rules must be laid down concerning the separation of lots and marking; whereas the labels should give the particulars needed both for official control and for the information of the user; Whereas rules should be established permitting, in the case of temporary supply difficulties, the marketing of propagating material and fruit plants subject to requirements less stringent than those contained in this Directive; Whereas, as a first step towards harmonized conditions, Member States should be prohibited in the case of the genera and species referred to in Annex II, for which schedules will be drawn up, from imposing new conditions or restrictions on the marketing, other than those provided for in this Directive; Whereas provisions should be made for authorizing the marketing, within the Community, of propagating material and fruit plants produced in third countries, provided always that they afford the same guarantees as propagating material and fruit plants produced in the Community and complying with Community rules; Whereas, in order to harmonize the technical methods of examination used in the Member States and to compare propagating material and fruit plants produced in the Community with those produced in third countries, comparative trials should be carried out to check compliance of such products with the requirements of this Directive; Whereas, in order to facilitate the effective operation of this Directive, the Commission should be entrusted with the task of adopting measures for its implementation and for the amendment of its Annex; and to provide a procedure to that end involving close cooperation between the Commission and the Member States within a Standing Committee on Propagating Material and Plants of Fruit Genera and Species, Article 1 1. This Directive applies to the marketing of fruit plant propagating material and fruit plants intended for fruit production within the Community. 2. Articles 2 to 20 and Article 24 shall apply to the genera and species listed in Annex II as well as to their hybrids. Rootstocks and other parts of plants of other genera or species or their hybrids shall also be subject to the abovementioned Articles if material of one of the said genera or species or their hybrids is grafted or is to be grafted onto them. 3. Amendments to the list of genera and species in Annex II shall be adopted in accordance with the procedure laid down in Article 22. Article 2 This Directive shall not apply to propagating material or fruit plants shown to be intended for export to third countries, if properly identified as such and kept sufficiently isolated, without prejudice to the health rules laid down by Directive 77/93/EEC. Implementing measures for the first paragraph, with particular reference to identification and isolation, shall be adopted in accordance with the procedure laid down in Article 21. Article 3 For the purposes of this Directive, the following definitions shall apply: (a) propagating material: seeds, parts of plants and all plant material, including rootstocks, intended for the propagation and production of fruit plants; (b) fruit plants: plants intended to be planted or replanted, after marketing: (c) pre-basic material: propagating material: (i) which has been produced according to generally accepted methods with a view to maintaining the identity of the variety, including the relevant characteristics of its pomological value, which can be established according to the procedure laid down in Article 21, and to preventing diseases; (ii) which is intended for the production of basic material; (iii) which satisfies the conditions for pre-basic material laid down in the schedule for the species concerned, established pursuant to Article 4, and (iv) which, following an official inspection, has been recognized as satisfying the abovementioned conditions; (d) basic material: propagating material: (i) which has been produced either directly or in a known number of stages in a vegetative way from pre-basic material, according to generally accepted methods, with a view to maintaining the identity of the variety, including the relevant characteristics of its pomological value, which can be established in accordance with the procedure laid down in Article 21, and to preventing disease; (ii) which is intended for the production of certified material; (iii) which satisfies the conditions for basic material laid down in the schedule for the species concerned, established pursuant to Article 4, and (iv) which, following an official inspection, has been recognized as satisfying the abovementioned conditions; (e) certified materials: propagating material and fruit plants: (i) which have been produced either directly or in a known number of stages in a vegetative way from basic material; (ii) which satisfy the conditions for certified material laid down in the schedule for the species concerned, established pursuant to Article 4. (iii) which, following an official inspection, has been recognized as satisfying the abovementioned conditions. (f) CAC (Conformitas Agraria Communitatis) material: propagating material and fruit plants satisfying the minimum conditions laid down for that category relative to the species concerned in the schedule established pursuant to Article 4; (g) virus-free (v.f.) material: material which has been tested and found free from infection according to internationally recognized scientific methods, has been found free from symptoms of any virus or virus-like pathogen by growing-season inspection, has been maintained under conditions ensuring freedom from infection, and is considered to be free from all viruses and virus-like pathogens known in the species concerned occurring in the Community. Material descended vegetatively in direct line in a specific number of stages from such material, found free from symptoms of any virus or virus-like pathogen by growing-season inspection, and produced and maintained under conditions ensuring freedom from infection, shall also be considered to be virus-free. The specific number of stages shall be indicated in the schedule for the species concerned, established pursuant to Article 4; (h) virus-tested (v.t.) material: material which has been tested and found free from infection according to internationally recognized scientific methods, found free from symptoms of any virus or virus-like pathogen by growing-season inspection, has been maintained under conditions ensuring freedom from infection, and considered to be free from certain serious viruses and virus-like pathogens known in the species concerned occurring in the Community and capable of reducing the usefulness of the material. Material descended vegetatively in direct line in a specific number of stages from such material, found free from symptoms of any virus or virus-like pathogen by growing-season inspection, and produced and maintained under conditions ensuring freedom from infection, shall also be considered to be virus-tested. The specific number of stages shall be indicated in the schedule for the species concerned, established pursuant to Article 4; (i) supplier: any natural or legal person carrying out professionally at least one of the following activities with regard to propagating material or fruit plants: reproducing, producing, preserving and/or treating, and marketing; (j) marketing: the holding available or in stock, displaying or offering for sale, selling and/or delivering to another person, in whatever form, of propagating material or fruit plants; (k) responsible official body (i) the sole and central authority, established or designated by the Member State under the supervison of the national government and responsible for questions concerning quality; (ii) any State authority established: - either at national level, - or at regional level, under the supervision of the national authorities, within the limits set by the national legislation of the Member State concerned. The bodies referred to in (i) and (ii) may, in accordance with their national legislation, delegate the tasks provided for in this Directive to be accomplished under their authority and supervision to any legal person, whether governed by public or private law, which, under its officially approved statute, is charged exclusively with specific public functions, provided that such person, and its members, has no personal interest in the outcome of the measures it takes. The Member States shall ensure that there is close cooperation between the bodies referred to in (ii) and those referred to in (i). Moreover, in accordance with the procedure laid down in Article 21, any other legal person established on behalf of a body referred to in (i) and (ii) and acting under the supervision and the control of such body, may be approved, provided that such person has no personal interest in the outcome of the measures it takes. The Member States shall notify the Commission of their responsible official bodies. The Commission shall forward that information to the other Member States; (l) official measures: measures taken by the responsible official body; (m) official inspection: inspection carried out by the responsible official body; (n) official statement: statement issued by or under the responsibility of the responsible official body; (o) lot: a number of units of a single commodity, identifiable by its homogeneity of composition and origin; (p) laboratory: a body under public or private law carrying out analysis and proper diagnosis, enabling the producer to monitor production quality. Article 4 1. In accordance with the procedure laid down in Article 22, a schedule shall be established in Annex I for each genus or species referred to in Annex II, with a reference to the plant health conditions laid down in Directive 77/93/EEC applying to the genus and/or species concerned and laying down: (i) the quality and plant health conditions with which CAC material must comply, in particular those relating to the propagation system applied, to the purity of the growing crop, and, except in the case of rootstocks, where the material does not belong to a variety, to varietal aspects. (ii) the conditions with which pre-basic, basic and certified material must comply, relating to quality, plant health, the testing methods and procedures applied, the propagation system(s) applied and, except in the case of rootstocks where the material does not belong to a variety, to varietal aspects; (iii) the conditions with which rootstocks and other parts of plants of other genera or species must comply if propagating material of the genus or species concerned is grafted onto them. 2. If in the schedule a reference is made to the qualification 'virus-free (v.f.)' or 'virus-tested (v.t.)', the viruses and virus-like pathogens concerned shall be mentioned in that schedule. This provision shall apply mutatis mutandis where reference is made to a qualification concerning freedom from or testing to detect harmful organisms other than viruses or virus-like pathogens. No reference shall be made to v.f. or v.t. in respect of the material referred to in subparagraph 1 (i). In respect of the material referred to in subparagraph 1 (ii), a reference to the aforementioned qualifications shall be made where such reference is relevant for the genus or species concerned. Article 5 1. Member States shall ensure that suppliers take all necessary measures to guarantee compliance with the standards laid down by this Directive at all stages of the production and marketing of propagating material and fruit plants. 2. For the purposes of paragraph 1, suppliers shall either carry out themselves, or have carried out by an accredited supplier or a responsible official body, checks based on the following principles: - identification of critical points in their production process on the basis of the production methods used, - establishment and implementation of methods for monitoring and checking the critical points referred to in the first indent, - taking samples for analysis in a laboratory accredited by the responsible official body for the purpose of checking compliance with the standards established by this Directive, - keeping a written record or a record registered in an indelible fashion, of the data referred to in the first, second and third indents, as well as records on production and marketing of propagating material and fruit plants, to be held at the disposal of the responsible official body. These documents shall be kept for a period of at least three years. However, suppliers whose activity in this connection is confined merely to the distribution of propagating material and fruit plants produced and packaged on premises other than their own shall be required only to keep a written record or a record registered in an indelible fashion of the buying and selling and/or delivery of propagating material and fruit plants. This paragraph shall not apply to suppliers whose activity in this connection is confined to the supply of small quantities of propagating material and fruit plants to non-professional final consumers. 3. If the result of their own checks or any information at the disposal of the suppliers referred to in paragraph 1 reveals the presence of one or more of the harmful organisms referred to in Directive 77/93/EEC or, in a quantity greater than that normaly allowed for in order to meet the standards, of those specified in the relevant schedules established pursuant to Article 4, the suppliers shall immediately report this to the responsible official body and shall carry out the measures indicated by that body or any other measure necessary to reduce the risk of such harmful organisms from spreading. The supplier shall keep records of all outbreaks of harmful organisms on his premises and of all measures taken in relation to such occurrences. 4. Detailed rules for the application of the second subparagraph of paragraph 2 shall be adopted in accordance with the procedure laid down in Article 21. Article 6 1. The responsible official body shall accredit suppliers once it has verified that their production methods and establishments meet the requirements of this Directive with regard to the nature of the activities they carry out. The accreditation must be renewed if a supplier decides to carry out activities other than those for which he has received accreditation. 2. The responsible official body shall accredit laboratories once it has verified that those laboratories, their methods, their establishments and their staff, meet the requirements of this Directive, to be specified according to the procedure laid down in Article 21, with regard to the testing activities they carry out. The accreditation must be renewed if a laboratory decides to carry out activities other than those for which it has received accreditation. 3. The responsible official body shall take the necessary measures if the requirements referred to in paragraphs 1 and 2 cease to be met. To this end, it shall take particular account of the conclusions of any check carried out in accordance with Article 7. 4. The supervision and monitoring of suppliers, establishments and laboratories shall be carried out regularly by or under the responsibility of the responsible official body, which shall at all times have free access to all parts of establishments, in order to ensure compliance with the requirements of this Directive. Implementing measures concerning supervision and monitoring shall be adopted, as necessary, in accordance with the procedure laid down in Article 21. If such supervision and monitoring reveal that the requirements of this Directive are not being met, the responsible official body shall take appropriate action. Article 7 1. Commission experts may, in cooperation with the responsible official bodies of the Member States, make on-the-spot checks in so far as this is necessary to ensure the uniform application of this Directive, and in particular to verify whether suppliers are in effect complying with the requirements of this Directive. A Member State in whose territory a check is being carried out shall give all necessary assistance to the experts in carrying out their duties. The Commission shall inform the Member States of the result of the investigations. 2. Detailed rules for the application of paragraph 1 shall be adopted in accordance with the procedure laid down in Article 21. Article 8 1. Propagating material or fruit plants may be marketed only by accredited suppliers, and provided they meet the requirements laid down for CAC material in the schedule referred to in Article 4. 2. Pre-basic, basic and certified material may not be certified unless it belongs to a variety referred to in Article 9 (2) (i) and unless it meets the requirements for the category concerned laid down in the schedule referred to in Article 4. The category shall be indicated on the official document referred to in Article 11. With regard to the varietal aspect, in the schedule to be drawn up in accordance with Article 4 provision may be made for an exemption for rootstocks where the material does not belong to a variety. 3. Without prejudice to the provisions of Directive 77/93/EEC, the previous paragraphs shall not apply to propagating material or fruit plants intended for: (a) trials or scientific purposes; or (b) selection work; or (c) measures for the conservation of genetic diversity. Detailed rules for the application of points (a) and (b) shall be adopted, as necessary, in accordance with the procedure laid down in Article 21. Detailed rules for the application of point (c) shall be adopted preferably before 1 January 1993, in accordance with the same procedure. Article 9 1. Propagating material and fruit plants shall be marketed with a reference to the variety to which they belong. Where, in the case of rootstocks, the material does not belong to a variety, reference shall be made to the species or interspecific hybrid concerned. 2. The varieties to which reference shall be made pursuant to paragraph 1 must be: (i) either commonly known, and protected in accordance with the provisions on the protection of new varieties of plants, or officially registered on a voluntary or other basis; (ii) or entered on lists kept by the suppliers, with their detailed descriptions and relevant denominations. These lists must be available, upon request, to the responsible official body of the Member State concerned. Each variety shall be described and, as far as possible, bear the same denomination in all Member States, in accordance with accepted international guidelines. 3. Varieties may be officially registered if they have been found to satisfy certain officially approved conditions and have an official description. They may also be officially registered if their material has been marketed in the territory of the Member State concerned prior to 1 January 1993, provided that they have an official description. In the latter case the registration shall expire not later than 30 June 2000, unless by that date the varieties in question have been: - either confirmed, in accordance with the procedure laid down in Article 21, with a detailed description if they have been officially registered in at least two Member States, - or registered in accordance with the first sentence. 4. Except where the varietal aspect is explicitly mentioned in the schedules referred to in Article 4, paragraphs (1) and (2) shall not entail any extra responsibility for the responsible official body. 5. Requirements for the official registration referred to in paragraph 2 (i) shall be established in accordance with the procedure laid down in Article 21, taking into account current scientific and technical knowledge and covering: (a) the conditions of official acceptance, which may include, in particular, distinctness, stability and sufficient uniformity; (b) the characteristics which as a minimum the examinations of the various species must cover; (c) the minimum requirements for carrying out the examinations; (d) the maximum period of validity of the official acceptance of a variety. 6. In accordance with the procedure laid down in Article 21: - a system for the notification of varieties or species or interspecific hybrids to the responsible official bodies of the Member States may be set up, - additional implementing provisions for paragraph 2 (ii) may be adopted, - it may be decided that a common catalogue of varieties may be established and published. Article 10 1. While growing and during lifting or removal from the parent material, propagating material and fruit plants shall be kept in separate lots. 2. If propagating material and fruit plants of different origins are put together or mixed during packaging, storage, transport or at delivery, the supplier shall keep records including the following data: composition of the lot and origin of its individual components. 3. Member States shall ensure compliance with the requirements referred to in paragraphs 1 and 2 by carrying out official inspections. Article 11 Without prejudice to Article 10 (2), propagating material and fruit plants shall be marketed only in sufficiently homogeneous lots and if they are: (i) qualified as CAC material and accompanied by a document made out by the supplier in accordance with the conditions laid down in the schedule established pursuant to Article 4. In an official declaration appears on this document, it shall be clearly separate from all other information in the document; or (ii) qualified as pre-basic, basic or certified material, and certified as such by the official responsible body in accordance with the conditions laid down in the schedule referred to in Article 4. Requirements in respect of propagating material and/or fruit plants with regard to labelling and/or sealing and packaging shall be indicated in the schedule referred to in Article 4. In the case of retail supply of propagating material or fruit plants to a non-professional final consumer, requirements regarding labelling may be confined to appropriate product information. Article 12 Member States may exempt: - from the application of Article 11, small producers all of whose production and sales of propagating material and fruit plants is intended for final use by persons on the local market who are not professionally involved in plant production ('local circulation'), - from the checks and official inspections provided for in Article 18, the local circulation of propagating materials and fruit plants produced by such exempt persons. In accordance with the procedure laid down in Article 21, implementing measures relating to other requirements concerning the exemptions referred to in the first and second indents, in particular as regards the concepts of 'small producers' and 'local market', and to the related procedures, shall be adopted. Article 13 In the event of temporary difficulties in the supply of propagating material and fruit plants satisfying the requirements of this Directive, measures may be adopted, in accordance with the procedure laid down in Article 21, concerning the marketing of propagating material and fruit plants meeting less stringent requirements, without prejudice to the plant-health rules laid down in Directive 77/93/EEC. Article 14 Propagating material and fruit plants which comply with the requirements and conditions of this Directive shall be subject to no marketing restrictions as regards supplier, plant health, growing medium and inspection arrangements, other than those laid down in this Directive. Article 15 As regards the products referred to in Annex II Member States shall refrain from imposing more stringent conditions or marketing restrictions other than the conditions laid down in the schedules referred to in Article 4 or those obtaining on the date of adoption of this Directive, as the case may be. Article 16 1. In accordance with the procedure laid down in Article 21, it shall be decided whether propagating material and fruit plants produced in a third country and affording the same guarantees as regards obligations on the supplier, identity, characteristics, plant health, growing medium, packaging, inspection arrangements, marking and sealing, are equivalent in all these respects to propagating material and fruit plants produced in the Community and complying with the requirements and conditions of this Directive. 2. Pending the decision referred to in paragraph 1, Member States may, until 1 January 1993, and without prejudice to the provisions of Directive 77/93/EEC, apply to the import of propagating material and fruit plants from third countries conditions at least equivalent to those indicated, on a temporary or permanent basis, in the schedules adopted pursuant to Article 4. If such conditions are not laid down in the schedules, the conditions for importation must be at least equivalent to those applicable to production in the Member State concerned. In accordance with the procedure laid down in Article 21, the date referred to in the first subparagraph may, for the various third countries, be extended pending the decisions referred to in paragraph 1. Propagating material and fruit plants imported by a Member State in accordance with a decision taken by that Member State pursuant to the first subparagraph shall be subject to no marketing restrictions in the other Member States as regards the matters referred to in paragraph 1. Article 17 Member States shall ensure that propagating material and fruit plants are officially inspected during production and marketing, and by random checks in the case of CAC material, to verify compliance with the requirements and conditions set out in this Directive. Article 18 Detailed rules for implementing the controls provided for in Article 5 and for the official inspection provided for in Articles 10 and 17, including sampling methods, shall be adopted in accordance with the procedure laid down in Article 21. Article 19 1. If, during the supervision and monitoring provided for in Article 6 (4), the official inspection referred to in Article 17, or the trials referred to in Article 20, it is found that propagating material or fruit plants do not meet the requirements of this Directive, the responsible official body of the Member State shall take appropriate action to ensure that they do comply with the provisions of this Directive or, if that is not possible, to ban the marketing of that propagating material or those fruit plants in the Community. 2. If it is found that propagating material or fruit plants marketed by a particular supplier do not comply with the requirements and conditions of this Directive, the Member State concerned shall ensure that appropriate measures are taken against that supplier. If the supplier is forbidden to market propagating material and fruit plants, the Member State shall accordingly inform the Commission and the competent national bodies in the Member States. 3. Any measures taken under paragraph 2 shall be withdrawn as soon as it has been established with sufficient certainty that the propagating material or fruit plants intended for marketing by the supplier will, in the future, comply with the requirements and conditions of this Directive. Article 20 1. Trials, or, where appropriate, tests shall be carried out in the Member States on samples to check that propagating material or fruit plants comply with the requirements and conditions of this Directive, including those relating to plant health. The Commission may organize inspections of the trials by representatives of the Member States and of the Commission. 2. It may be decided in accordance with the procedure laid down in Article 21 that it is necessary to carry out Community trials or tests for the same purpose as mentioned in paragraph 1. The Commission may organize inspections of Community trials by representatives of the Member States and of the Commission. 3. The trials or tests referred to in paragraphs 1 and 2 shall be used to harmonize technical methods of examination of propagating material and fruit plants. Progress reports shall be made on the trials or tests and sent in confidence to the Member States and to the Commission. 4. The Commission shall ensure that, where necessary, arrangements for coordinating, carrying out and inspecting the trials referred to in paragraphs 1 and 2, and assessing their results, are adopted by the Committee set up by Article 21. When plant health problems occur, the Commission shall notify the Standing Committee on Plant Health. If necessary, specific arrangements shall be adopted. Propagating material and fruit plants produced in third countries shall be included in the trials. Article 21 1. The Commission shall be assisted by a committee, referred to as the 'Standing Committee on Propagating Material and Plants of Fruit Genera and Species', chaired by a representative of the Commission. 2. The representative of the Commission shall submit to the standing committee a draft of the measures to be taken. The standing 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. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the standing committee between shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. The Commission shall adopt measures which shall apply immediately. However, if these measures are not in accordance with the opinion of the standing committee, they shall be communicated by the Commission to the Council forthwith. In that event, the Commission may defer application of the measures which it has decided for a period of not more than one month from the date of such communication. The Council, acting by a qualified majority, may take a different decision within the time limit referred to in the previous paragraph. Article 22 1. The Commission shall be assisted by the Standing Committee on Propagating Material and Plants of Fruit Genera and Species, chaired by the representative of the Commission. 2. The representative of the Commission 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. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. If 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 relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 23 Amendments to the schedules established pursuant to Article 4 and to the conditions and detailed rules adopted for the implementation of this Directive shall be adopted in accordance with the procedure laid down in Article 21. Article 24 1. Member States shall ensure that propagating material and fruit plants produced in their territory and intended for marketing comply with the requirements of this Directive. 2. If it is found, during an official inspection, that propagating material or fruit plants cannot be marketed because they fail to comply with a condition relating to plant health, the Member State concerned shall take appropriate official measures to eliminate any consequent plant-health risk. Article 25 Within five years from the date of adoption of this Directive, the Commission shall examine the results of its application and submit to the Council a report, accompanied by any necessary proposals for amendments. Article 26 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive no later than 31 December 1992. They shall forthwith inform the Commission thereof. When these measures are adopted by the Member States, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods for making such reference shall be adopted by the Member States. 2. As far as Articles 5 to 11, 14, 15, 17, 19 and 24 are concerned, the date of application for each genus or species referred to in Annex II shall be fixed in accordance with the procedure provided for in Article 21, when the schedule referred to in Article 4 is drawn up. Article 27 This Directive is addressed to the Member States.

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Council Directive 92/36/EEC of 29 April 1992 amending, with regard to African horse sickness, Directive 90/426/EEC on animal health conditions governing the movement and import from third countries of equidae Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 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), Wheres Directive 90/426/EEC (4) lays down animal health conditions governing the movement and import from third countries of equidae; whereas the said Directive indicates the limits of the territory infected with African horse sickness and the rules applicable to Member States not free from the disease; Whereas Directive 92/35/EEC (5) has laid down the control rules; whereas Directive 90/426/EEC must be amended accordingly in order to take account of these provisions, Article 1 Article 5 of Directive 90/426/EEC shall be replaced by the following: 'Article 5 1. A Member State which is not free of African horse sickness within the meaning of Article 2 (f) may dispatch equidae from that part of its territory which is considered to be infected within the meaning of paragraph 2 of this Article only under the conditions set out in paragraph 3 of this Article. 2. (a) A part of the territory of a Member State shall be considered to be infected with African horse sickness if: - clinical, serological (in unvaccinated animals) and/or epidemiological evidence has revealed the presence of African horse sickness in the past two years, or - vaccination against African horse sickness has been carried out in the past 12 months. (b) The part of the territory considered to be infected with African horse sickness must comprise as a minimum: - a protection zone with a radius of at least 100 km around any centre of infection, - a surveillance zone at least 50 km extending beyond the protection zone, in which no vaccination has been carried out in the last 12 months. (c) The rules controlling the combat measures relating to the territories and zones referred to in points (a) and (b) and the relevant derogations are specified in Directive 92/35/EEC (6)(). (d) All vaccinated equidae found in the protection zone must be registered and identified in accordance with Article 6 (1) of Directive 92/35/EEC. The identification document and/or health certificate shall carry a clear reference to such vaccination. 3. A Member State may dispatch from the territory referred to in paragraph 2 (b) only equidae which meet the following requirements: (a) they must be dispatched only during certain periods of the year, having regard to the activity of vector insects, to be determined in accordance with the procedure laid down in Article 25; (b) they must show no clinical symptom of African horse sickness on the day of the inspection referred to in Article 4 (1); (c) - if they have not been vaccinated against African horse sickness, they must have undergone and reacted negatively to a complement fixation test for African horse sickness as described in Annex D, on two occasions, with an interval of between 21 and 30 days between the two tests, the second of which must have been carried out during the 10 days prior to dispatch, - if they have been vaccinated, they must not have undergone vaccination during the previous two months and must have undergone the fixation test described in Annex D at the aforementioned intervals without having recorded an increase in the antibody count. Under the procedure laid down in Article 24, the Commission may, following the opinion of the Scientific Veterinary Committee, recognize other monitoring methods; (d) they must have been kept in a quarantine station for a minimum period of 40 days prior to dispatch; (e) they must have been protected from vector insects during the period of quarantine and during transportation from the quarantine station to the place of dispatch. (7)() OJ No L 157, 10. 6. 1992, p. 19.' Article 2 Commission Decisions 90/552/EEC (8), 90/553/EEC (9), 91/93/EEC (10) and 92/101/EEC (11) shall continue to apply for the purposes of this Directive. Under the procedure laid down in Article 19 of Directive 92/35/EEC, the abovementioned Decisions may be amended with a view to adapting their scope to the provisions of this Directive or with a view to their future adaptation to scientific and technological developments. Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 31 December 1992. The shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. Article 4 This Directive is addressed to the Member States.

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1992

Council Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances 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 disparity between the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances and to the notification of new substances in the Member States may lead to barriers to trade between Member States and create unequal conditions of competition; whereas the disparity between these measures in the Member States has a direct impact on the functioning of the internal market and does not guarantee the same level of protection of public health and the environment; Whereas measures for the approximation of the provisions of the Member States which have as their object the establishment and functioning of the internal market shall, inasmuch as they concern health, safety and the protection of man and the environment, take as their basis a high level of protection; Whereas, in order to protect man and the environment from potential risks which could arise from the placing on the market of new substances, it is necessary to lay down appropriate measures and in particular to amend and reinforce the provisions of Council Directive 67/548/ EEC (4), as last amended by Directive 90/517/EEC (5); Whereas any new substance placed on the market should be notified to the competent authorities by means of a notification containing certain information; whereas, in the case of substances placed on the market in quantities of less than one tonne per year per manufacturer, the notification requirements may be reduced; whereas, however, where the quantity of a substance placed on the market exceeds certain limits, provision should be made for additional studies; Whereas it is necessary to lay down measures to make it possible to introduce a notification procedure under which a notification made in one Member State is then valid for the Community; whereas it may be worthwhile, in the case of substances manufactured outside the Community, for the manufacturer to appoint an exclusive representative in the Community for the purpose of notification; Whereas, in order to forecast the effects on man and the environment, it is advisible that any new substance that is notified be the subject of an assessment of the risks, and whereas uniform principles for risk assessment should be laid down; Whereas it is, moreover, important to follow closely the evolution and use of new substances placed on the market and whereas it is therefore necessary to institute a system which allows all new substances to be listed; Whereas the Commission, pursuant to Article 13 (1) of Directive 67/548/EEC (6), drew up, in accordance with the guidelines laid down in Commission Decision 81/437/EEC, an inventory of substances on the Community market as at 18 September 1981 (EINECS); whereas that inventory was published in the Official Journal of the European Communities (7); Whereas it is appropriate to reduce to a minimum the number of animals used for experimental purposes, in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of the laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (8); whereas all appropriate measures should be taken to avoid the duplication of tests on animals; Whereas Council Directive 87/18/EEC of 18 December 1986 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances (9) specifies the Community principles of good laboratory practice which must be followed for tests on chemicals; Whereas, in order to promote environmental protection and safety and health at work, it is desirable for safety data on dangerous substances to be available to professional users; Whereas provisions should be adopted at Community level on the classification and labelling of substances in order to promote the protection of the population and, in particular, of the workers who use them; Whereas, in order to ensure an adequate level of protection for man and the environment, it is necessary to introduce measures for the packaging and provisional labelling of dangerous substances not appearing in Annex I to Directive 67/548/EEC; whereas, for the same reason, it is necessary to make the indication of safety advice mandatory; Whereas Article 2 of Directive 67/548/EEC classifies substances and preparations as toxic, harmful, corrosive or irritant by the use of general definitions; whereas experience has shown that it is necessary for this classification to be improved upon; whereas it seems appropriate to provide precise criteria for classification; whereas, in addition, Article 3 of the Directive provides for an assessment of the environmental hazard, making it necessary to enumarate certain characteristics and parameters of assessment and to establish a phased test programme; Whereas it is desirable to add a new common danger symbol, 'dangerous for the environment', to appear on packaging; Whereas the confidential nature of certain information covered by individual or commercial secrecy should be guaranteed; Whereas Member States should be allowed to take safeguard measures, under certain conditions; Whereas the Commission should be given the powers necessary to adapt all the Annexes to Directive 67/548/EEC to technical progress, Article 1 Directive 67/548/EEC is hereby amended as follows: 1. Article 1 to 23 shall be replaced by the following Articles: 'Article 1 Objectives and Scope 1. The purpose of this Directive is to approximate the laws, regulations and administrative provisions of the Member States on: (a) the notification of substances; (b) the exchange of information on notified substances; (c) the assessment of the potential risk to man and the environment of notified substances; (d) the classification, packaging and labelling of substances dangerous to man or the environment, where such substances are placed on the market in the Member States. 2. This Directive shall not apply to the following preparations in the finished state, intended for the final user: (a) medicinal products for human or veterinary use, as defined in Directive 65/65/EEC (10), as last amended by Directive 87/21/EEC (11); (b) cosmetic products defined by Directive 76/768/EEC (12), as last amended by Directive 86/199/EEC (13); (c) mixtures of substances which, in the form of waste, are covered by Directives 75/442/EEC (14) and 78/319/EEC (15); (d) foodstuffs; (e) animal feedingstuffs; (f) pesticides; (g) radioactive substances as defined by Directive 80/836/EEC (16); (h) other substances or preparations for which Community notification or approval procedures exist and for which requirements are equivalent to those laid down in this Directive. Not later than 12 months after notification of this Directive, the Commission, in accordance with the procedure laid down in Article 29 (4) (a), shall establish a list of substances and preparations referred to above. This list will be re-examined periodically and as necessary revised in accordance with the said procedure. In addition, this Directive shall not apply to: - the carriage of dangerous substances by rail, road, inland waterway, sea or air, - substances in transit which are under customs supervision, provided they do not undergo any treatment or processing. (17) OJ No 22, 9. 2. 1965, p. 369. (18) OJ No L 15, 17. 1. 1987, p. 36. (19) OJ No L 262, 27. 9. 1976, p. 169. (20) OJ No L 149, 3. 6. 1986, p. 38. (21) OJ No L 194, 15. 7. 1975, p. 39. (22) OJ No L 84, 31. 3. 1978, p. 43. (23) OJ No L 246, 17. 9. 1980, p. 1. Article 2 Definitions 1. For the purpose of this Directive: (a) "substances" means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition; (b) "preparations" means mixtures or solutions composed of two or more substances; (c) "polymer" means a substance consisting of molecules characterized by the sequence of one or more types of monomer units and comprising a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant and consists of less than a simple weight majority of molecules of the same molecular weight. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. In the context of this definition a "monomer unit" means the reacted form of a monomer in a polymer; (d) "notification" means the documents, with the requisite information, presented to the competent authority of a Member State: - for substances manufactured within the Community, by the manufacturer who places a substance either on its own or in a preparation on the market, - for substances manufactured outside the Community, by any person established in the Community who is responsible for placing the substance either on its own or in a preparation on the Community market, or alternatively by the person established within the Community who is, for the purposes of submitting a notification for a given substance placed on the Community market, either on its own or in a preparation, designated by the manfacturer as his sole representative. The person submitting the notification, as described above, shall be referred to as "the notifier". (e) "placing on the market" means the making available to third parties. Importation into the Community customs territory shall be deemed to be placing on the market for the purposes of this Directive; (f) "scientific research and development" means scientific experimentation, analysis or chemical research carried out under controlled conditions; it includes the determination of intrinsic properties, performance and efficacy as well as scientific investigation related to product development; (g) "process-orientated research and development" means the further development of a substance in the course of which pilot plant or production trials are used to test the fields of application of the substance; (h) "EINECS" means the European Inventory of Existing Commercial Substances. This inventory contains the definitive list of all substances deemed to be on the Community market on 18 September 1981. 2. The following are "dangerous" within the meaning of this Directive: (a) explosive substances and preparations: solid, liquid, pasty or gelatinous substances and preparations which may also react exothermically without atmospheric oxygen thereby quickly evolving gases, and which, under defined test conditions, detonate, quickly deflagrate or upon heating explode when partially confined; (b) oxidizing substances and preparations: substances and preparations which give rise to a highly exothermic reaction in contact with other substances, particularly flammable substances; (c) extremely flammable substances and preparations: liquid substances and preparations having an extremely low flash-point and a low boiling-point and gaseous substances and preparations which are flammable in contact with air at ambient temperature and pressure; (d) highly flammable substances and preparations: - substances and preparations which may become hot and finally catch fire in contact with air at ambient temperature without any application of energy, or - solid substances and preparations which may readily catch fire after brief contact with a source of ignition and which continue to burn or to be consumed after removal of the source of ignition, or - liquid substances and preparations having a very low flash-point, or - substances and preparations which, in contact with water or damp air, evolve highly flammable gases in dangerous quantities; (e) flammable substances and preparations: liquid substances and preparations having a low flash-point; (f) very toxic substances and preparations: substances and preparations which in very low quantities cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin; (g) toxic substances and preparations: substances and preparations which in low quantities cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin; (h) harmful substances and preparations: substances and preparations which may cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin; (i) corrosive substances and preparations: substances and preparations which may, on contact with living tissues, destroy them; (j) irritant substances and preparations: non-corrosive substances and preparations which, through immediate, prolonged or repeated contact with the skin or mucous membrane, may cause inflammation; (k) sensitizing substances and preparations: substances and preparations which, if they are inhaled or if they penetrate the skin, are capable of eliciting a reaction of hypersensitization such that on further exposure to the substance or preparation, characteristic adverse effects are produced; (l) carcinogenic substances and preparations: substances or preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce cancer or increase its incidence; (m) mutagenic substances and preparations: substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce heritable genetic defects or increase their incidence; (n) substances and preparations which are toxic for reproduction: substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may produce, or increase the incidence of, non-heritable adverse effects in the progeny and/or an impairment of male or female reproductive functions or capacity; (o) substances and preparations which are dangerous for the environment: substances and preparations which, were they to enter the environment, would present or may present an immediate or delayed danger for one or more components of the environment. Article 3 Testing and assessment of the properties of substances 1. Tests on chemicals carried out within the framework of this Directive shall as a general principle be conducted according to the methods laid down in Annex V. The physico-chemical properties of substances shall be determined according to the methods specified in Annex V. A; their toxicity shall be determined according to the methods specified in Annex V. B and their ecotoxicity according to the methods specified in Annex V. C. However, for some of the substances on the EINECS it is possible that test data exist which have been generated by methods other than those laid down in Annex V. The adequacy of such data for the purposes of classification and labelling and the need to conduct new tests according to Annex V must be decided on a case-by-case basis taking into account among other factors the need to minimize testing on vertebrate animals. Laboratory tests shall be carried out in compliance with the principles of good laboratory practice provided for in Directive 87/18/EEC and with the provisions of Directive 86/609/EEC. 2. The real or potential risk to man and the environment shall be assessed on the basis of the principles adopted, by 30 April 1993, in accordance with the procedure laid down in Article 29 (4) (b). These principles shall be regularly reviewed and, where appropriate, revised in accordance with the same procedure. Article 4 Classification 1. Substances shall be classified on the basis of their intrinsic properties according to the categories laid down in Aricle 2 (2). In the classification of substances, impurities shall be taken into account as far as the concentration(s) of the latter exceed the concentration limits specified in paragraph 4 of this Article and in Article 3 of Directive 88/379/EEC. 2. The general principles of the classification and labelling of substances and preparations shall be applied according to the criteria in Annex VI (24), save where contrary requirements for dangerous preparations are specified in separate Directives. 3. Annex I (25) contains the list of substances classified in accordance with the principles outlined in paragraphs 1 and 2, together with their harmonized classification and labelling. The decision to place a substance in Annex I together with the harmonized classification and labelling shall be taken in accordance with the procedure laid down in Article 29. 4. The dangerous substances listed in Annex I shall, where appropriate, be characterized by concentration limits or any other parameter enabling an assessment to be made of the health or environmental hazard of preparations containing the said dangerous substances or substances containing other dangerous substances as impurities. (26) See also OJ No L 257, 16. 9. 1983, p. 1. (27) See also the following adaptations to technical progress: - OJ No L 360, 30. 12. 1976, p. 1. - OJ No L 88, 7. 4. 1979, p. 1. - OJ No L 351, 7. 12. 1981, p. 5. - OJ No L 106, 21. 4. 1982, p. 18. - OJ No L 257, 16. 9. 1983, p. 1. - OJ No L 247, 1. 9. 1986, p. 1. - OJ No L 239, 21. 8. 1987, p. 1. - OJ No L 259, 19. 9. 1988, p. 1. Article 5 Duties of the Member States 1. Without prejudice to Article 13, Member States shall take all the necessary measures to ensure that substances cannot be placed on the market on their own or in preparations unless they have been: - notified to the competent authority of one of the Member States in accordance with this Directive, - packaged and labelled in accordance with Articles 22 to 25 and with the criteria in Annex VI, and in accordance with the results of the tests provided for in Annexes VII and VIII, save in the case of preparations where provisions exist in other Directives. In addition, Member States shall take all the necessary measures to ensure that the provisions concerning safety data sheets as laid down in Article 27 are observed. 2. The measures referred to in the second indent of paragraph 1 shall apply until the substance is listed in Annex I or until a decision not to list it has been taken in accordance with the procedure laid down in Article 29. Article 6 Obligation to carry out investigations Manufacturers, distributors and importers of dangerous substances which appear in the EINECS but which have not yet been introduced into Annex I shall be obliged to carry out an investigation to make themselves aware of the relevant and accessible data which exist concerning the properties of such substances. On the basis of this information, they shall package and provisionally label these substances according to the rules laid down in Articles 22 to 25 and the criteria in Annex VI. Article 7 Full notification 1. Without prejudice to Articles 1 (2), 8 (1), 13 and 16 (1), any notifier of a substance shall be required to submit to the competent authority referred to in Article 16 (1) of the Member State in which the substance is manufactured, or in the case of a manufacturer located outside the Community, the Member State within which the notifier is established, a notification including: - a technical dossier supplying the information necessary for evaluating the foreseeable risks, whether immediate or delayed, which the substance may entail for man and the environment, and containing all available relevant data for this purpose. As a minimum, the dossier shall contain the information and results of the studies referred to in Annex VII. A, together with a detailed and full description of the studies conducted and of the methods used or a bibliographical reference to them, - a declaration concerning the unfavourable effects of the substance in terms of the various foreseeable uses, - the proposed classification and labelling of the substance in accordance with this Directive, - in the case of dangerous substances only, a proposal for a safety data sheet as provided for in Article 27, - in the case of a manufacturer located outside the Community, the notifier shall, in accordance with Article 2 (1) (d), second indent, include, if appropriate, a statement from the manufacturer to the effect that, for the purpose of submitting a notification for the substance in question, he is designated as the manufacturer's sole representative, - if so desired, a statement by the notifier requesting, on reasoned grounds, that the notification be exempted from the provisions of Article 15 (2) for a maximum period which shall not in any case exceed one year following the date of notification. Besides the information referred to above, the notifier may also provide the authority with a preliminary assessment of the risks, which he has made in accordance with the principles laid down in Article 3 (2). 2. Without prejudice to Article 14, any notifier of a substance already notified shall inform the competent authority: - when the quantity of the substance placed on the market reaches 10 tonnes per year per manufacturer or when the total quantity placed on the market reaches 50 tonnes per manufacturer; in this case, the competent authority may require some or all of the additional tests/studies laid down in Annex VIII, level 1, to be carried out within a time limit it will determine, - when the quantity of the substance placed on the market reaches 100 tonnes per year per manufacturer or when the total quantity placed on the market reaches 500 tonnes per manufacturer; in this case, the competent authority shall require the additional tests/studies laid down in Annex VIII, level 1, to be carried out within a time limit it will determine, unless the notifier can give good reason why a given test/study is not appropriate or an alternative scientific test/study would be preferable, - when then quantity of a substance placed on the market reaches 1 000 tonnes per year per manufacturer or when the total quantity placed on the market reaches 5 000 tonnes per manufacturer; in this case, the competent authority shall draw up a programme of tests/studies according to Annex VIII, level 2, to be carried out by the notifier within a time limit which the competent authority will determine. 3. When additional testing is carried out either in accordance with the requirements of paragraph 2 or voluntarily, the notifier shall provide the competent authority with the results of the studies carried out. Article 8 Reduced notification requirements for substances placed on the market in quantities of less than one tonne per annum per manufacturer 1. Without prejudice to Articles 1 (2), 13 (1) and 16 (1), any notifier intending to place a substance on the Community market in quantities of less than one tonne per annum per manufacturer shall be required to submit to the competent authority referred to in Article 16 (1) of the Member State in which the substance is produced, or in the case of a manufacturer located outside the Community, the Member State within which the notifier is established, a notification including: - a technical dossier supplying the information necessary for evaluating the foreseeable risks, whether immediate or delayed, which the substance may entail for man and the environment, and containing all available relevant data for this purpose. As a minimum, the dossier shall contain the information and results of the studies referred to in Annex VII. B, together with a full and detailed description of the studies conducted and of the methods used or a bibliographical reference to them if the Member State in which the notification is made so requires, - all the other information referred to in Article 7 (1). 2. When the quantities to be placed on the market are below 100 kg per year per manufacturer the notifier may, without prejudice to Article 16 (1), restrict the information in the technical dossier of the said notification above to that provided for in Annex VII. C. 3. In the case of a notifier who has submitted a reduced notification dossier in conformity with paragraph 2, he shall, before the quantity of the substance placed on the market reaches 100 kg per year per manufacturer or before the total quantity placed on the market reaches 500 kg per manufacturer, provide the competent authority with the additional information necessary to complete the technical dossier to the level of Annex VII. B. 4. Similarly, when a notifier has submitted a reduced notification dossier in conformity with paragraph 1 he shall, before the quantity of the substance placed on the market reaches 1 tonne per year per manufacturer, or before the total quantity placed on the market reaches 5 tonnes per manufacturer, submit a full notification according to the requirements of Article 7. 5. The substances notified in conformity with paragraphs 1 and 2 must, in so far as the notifier may reasonably be expected to be aware of their dangerous properties, be packaged and provisionally labelled in accordance with the rules laid down in Articles 22 to 25 and with the criteria imposed in Annex VI. Where it is not yet possible to label them in accordance with the principles set out in Article 23, the label should bear, in addition to the label deriving from the tests already carried out, the warning "Caution - substance not yet fully tested". Article 9 Substances already notified (10-year rule) A notifier need not supply the information required under Articles 7 and 8 for the technical dossiers in Annexes VII. A, VII. B, VII. C and VII. D with the exception of items 1 and 2 thereof, if the data were originally submitted at least 10 years previously. Article 10 Placing of notified substances on the market 1. Substances notified under Article 7 may, in the absence of any indication to the contrary from the competent authority, be placed on the market no sooner than 60 days after receipt by the authority of a dossier in conformity with the requirements of this Directive. If the competent authority considers that the dossier is not in conformity with the Directive and advises the notifier accordingly, as provided for in Article 16 (2), the substance may be placed on the market only 60 days after receipt by the authority of the information necessary to bring the notification into conformity with the Directive. 2. Substances notified under Article 8 (1) or (2) may, in the absence of any indication to the contrary from the competent authority, be placed on the market no sooner than 30 days after receipt by the authority of a dossier in conformity with the requirements of this Directive. If the competent authority considers that the dossier is not in conformity with the Directive and advises the notifier accordingly, as provided for in Article 16 (3), the substance may be placed on the market only 30 days after receipt by the authority of the information necessary to bring the notification into conformity with the Directive. However, if the notifier has received notice in accordance with Article 16 (3) that the dossier has been accepted, the substance may be placed on the market no sooner than 15 days after receipt of the dossier by the competent authority. Article 11 Substances manufactured outside the Community Where, for substances manufactured outside the Community, more than one notification exists for a substance manufactured by the same manufacturer, the cumulative yearly tonnages placed on the Community market shall be determined by the Commission and the national authorities on the basis of the information submitted under Articles 7 (1), 8 (1) and 14. The obligation to carry out supplementary testing in accordance with Article 7 (2) will fall collectively on all notifiers. Article 12 Polymers For polymers, the specific provisions concerning the technical dossiers contained in the notifications and referred to in Articles 7 (1) and 8 (1) shall be laid down in Annex VII, in the form of Annex VII. D, in accordance with the procedure referred to in Article 29 (4) (b). Article 13 Exemptions 1. The following substances shall be exempt from the provisions of Articles 7, 8, 14 and 15: - substances which appear on the EINECS inventory, - additives and substances for exclusive use in animal feedingstuffs as covered by Directives 70/524/EEC and 82/471/EEC (28), - substances used exclusively as additives in foodstuffs, as covered by Directive 89/107/EEC (29), and substances used exclusively as flavourings in foodstuffs and which are covered by Directive 88/388/EEC, - active ingredients used exclusively in the medicinal products referred to in Article 1 (2) (a). This does not include chemical intermediates, - substances for exclusive use in other product sectors for which Community notification or approval procedures exist and for which the requirements for data submission are equivalent to those laid down in this Directive. Not later than 12 months after notification of this Directive, the Commission, in accordance with the procedure laid down in Article 29 (4) (a), shall establish a list of such Community legislation. This list will be re-examined periodically and, as necessary, revised in accordance with the said procedure. 2. The substances listed below shall be considered as having been notified within the meaning of this Directive when the following conditions are fulfilled: - polymers, with the exception of those which contain in combined form 2 % or more of any substance which is not on EINECS, - substances placed on the market in quantities of less than 10 kg per year per manufacturer, provided the manufacturer/importer satisfies all the conditions imposed by the Member States in which the substance is placed on the market. These conditions shall not exceed the information provided for in Annex VII. C, points 1 and 2, - substances placed on the market in limited quantities, and in any case not exceeding 100 kg per manufacturer per year, and intended solely for purposes of scientific research and development carried out under controlled conditions. Any manufacturer or importer making use of this exemption must maintain written records containing the identity of the substance, labelling data, quantities and a list of customers; this information shall be made available upon request to the competent authorities of each Member State where the manufacture, importation or scientific research and development takes place, - substances placed on the market for the purposes of process-orientated research and development with a limited number of registered customers in quantities which are limited to the purpose of process-orientated research and development. These substances shall qualify for an exemption for a period of one year provided that the manufacturer or importer communicates their identity, labelling data, quantity, the justification for the quantity and a list of customers and the research and development programme to the competent authorities of each Member State where the manufacture, importation or process-orientated research and development takes place and complies with any conditions imposed by these authorities or the Member States on such research and development. The conditions imposed by the Member States may include information not exceeding that provided for in Article 8. After one year, these substances will normally be subject to notification. The manufacturer or importer shall also give an assurance that the substance or the preparation in which it is incorporated will be handled only by customers' staff in controlled conditions and will not be made available to the general public at any time either on its own or in a preparation. In addition, if the competent authority considers that there may exist an unacceptable risk for man and the environment, it may extend the restriction referred to above to include any products containing the new substances which were produced during the process-orientated research and development. The one-year exemption period referred to above may in exceptional circumstances be extended for a further year if the notifier can demonstrate, to the satisfaction of the competent authorities, that such an extension is justified. 3. The substances referred to in paragraph 2 must, in so far as the manufacturer may reasonably be expected to be aware of their dangerous properties, be packaged and provisionally labelled by the manufacturer or his representative in accordance with the rules laid down in Articles 22 to 25 and with the criteria imposed in Annex VI. If it is not possible to label the substances completely, and in accordance with the principles set out in Article 23, because the results of tests provided for in Annex VII. A are not all available, the label should bear, in addition to the label deriving from tests already carried out, the warning "Caution - substance not yet fully tested". 4. Where a substance as referred to in paragraph 2, labelled in accordance with the principles set out in Article 23, is very toxic, toxic, carcinogenic, toxic for reproduction or mutagenic, the manufacturer or importer of such a substance must transmit to the competent authority any appropriate information as regards Annex VII. A, Sections 2.3, 2.4 and 2.5. Moreover, acute toxicity data shall be given where available. (30) OJ No L 213, 21. 7. 1982, p. 8. (31) OJ No L 40, 11. 2. 1989, p. 27. Article 14 Follow-up information 1. Any notifier of a substance already notified in conformity with Articles 7 (1) or 8 (1) shall be responsible on his own initiative for informing in writing the competent authority to which the initial notification was submitted of: - changes in the annual or total quantities placed on the Community market by him or, in the case of a substance manufactured outside the Community for which the notifier has been designated as sole representative, by him and/or others, - new knowledge of the effects of the substance on man and/or the environment of which he may reasonably be expected to have become aware, - new uses for which the substance is placed on the market of which he may reasonably be expected to have become aware, - any change in the composition of the substances as given in Annex VII. A, B or C, section 1.3, - any change in his status (manufacturer or importer). 2. Any importer of a substance produced by a manufacturer established outside the Community who imports the substance within the framework of a notification previously submitted by a sole representative in accordance with Article 2 (1) (d) shall be required to ensure that the sole representative is provided with up-to-date information concerning the quantities of the substance introduced by him on to the Community market. Article 15 Renotification of the same substance and avoidance of duplicating testing on vertebrate animals 1. In the case of a substance which has already been notified in accordance with Articles 7 (1) or 8 (1), the competent authority may agree that the subsequent notifier of that substance may, for the purposes of sections 3, 4 and 5 of Annex VII. A and B and sections 3 and 4 of Annex VIII. C, refer to the results of the tests/studies forwarded by the first notifier, in so far as the subsequent notifier can provide evidence that the substance renotified is the same as the one previously notified, including the degree of purity and the nature of impurities. The first notifier must give his agreement in writing to the reference to the results of the tests/studies he has forwarded before such reference can be made. 2. Before carrying out testing on vertebrate animals for the purpose of submitting a notification in conformity with Articles 7 (1) or 8 (1), and without prejudice to paragraph 1, prospective notifiers shall enquire of the competent authorities of the Member State within which they intend subsequently to notify; as to: (a) whether or not the substance they intend to notify has already been notified; and (b) the name and address of the first notifier. This enquiry shall be supported by evidence that the prospective notifier has intention to place the substance on the market and of the quantities he intends to place on the market. In the event that: (a) the competent authority receiving the enquiry is satisfied that the prospective notifier intends to place the substance on the market in the quantities stated; and (b) the substance has been notified previously; and (c) the first notifier has not requested and been granted a temporary exemption from the provisions of this Article, the competent authority shall provide the prospective notifier with the name and address of the first notifier and shall inform the first notifier of the name and address of the prospective notifier. The first notifier and the prospective notifier shall take all reasonable steps to reach an agreement on the sharing of information so as to avoid the duplication of testing on vertebrate animals. 3. Notifiers of the same substance who have agreed to share information relating to Annex VII in accordance with paragraphs 1 and 2 shall also take all necessary steps to reach an agreement on the sharing of information derived from testing on vertebrate animals submitted in conformity with Article 7 (2). 4. If, despite the provisions of paragraphs 2 and 3, notifiers and prospective notifiers of the same substance can still not reach an agreement on the sharing of data, Member States may, for notifiers and prospective notifiers located within their territory, introduce national measures obliging notifiers and prospective notifiers to share the data with a view to avoiding duplicative testing on vertebrate animals and determine both the procedure for utilizing information, including regulations on the temporary exemption referred to in the final indent of Article 7 (1) and the reasonable balance of the interests of the parties concerned. Article 16 Rights and duties of the authorities 1. Member States shall appoint the competent authority or authorities responsible for receiving the information provided for in Articles 7 to 14 and examining its conformity with the requirements of this Directive. Moreover, if it can be shown to be necessary for the evaluation of the risk which may be caused by a substance, the competent authorities may ask for further information, verification and/or confirmatory tests concerning the substances or their transformation products, of which they have been notified or have received information under this Directive; this may also include requesting any of the information referred to in Annex VIII earlier than provided for in Article 7 (2). Additionally, the competent authorities may: - carry out such sampling as is necessary for control purposes, - require the notifier to supply such quantities of the notified substance as it deems necessary for the carrying out of verification tests, - take appropriate measures relating to safe use of a substance pending the introduction of Community provisions. In the case of substances notified in accordance with Articles 7 (1) and 8 (1) and (2), the competent authority which received notification shall carry out an assessment of the risks in accordance with the general principles laid down in Article 3 (2). The assessment shall include recommendations on the most appropriate method for testing the substance and, where appropriate, also include recommendations on measures which will enable the risk for man and the environment in connection with the marketing of the substance to be lessened. The assessment shall be updated from time to time in the light of additional information provided under this Article or Articles 7 (2), 8 (3) and 14 (1). 2. In the case of notifications submitted in conformity with Article 7, within a period of 60 days following receipt of the notification, the authority shall inform the notifier in writing as to whether the notification has, or has not, been accepted as being in conformity with this Directive. If the dossier is accepted, the authority shall at the same time advise the notifier of the official number which has been allocated to the notification. If the dossier is not accepted, the authority shall inform the notifier as to what further information he is required to provide in order to bring the dossier into conformity with this Directive. 3. For notifications submitted in accordance with Article 8, the competent authority shall, within a period of 30 days following receipt of the notification, decide whether the notification is in conformity with this Directive and, where the notification is adjudged not to be in conformity, inform the notifier as to what further information he is required to provide in order to bring the dossier into conformity with the Directive. Where the notification is in conformity with the Directive, the authority shall, within the same period, advise the notifier of the official number which has been allocated to his notification. 4. For substances manufactured outside the Community for which more than one notification has been submitted for the substance produced by one manufacturer, the competent authorities, together with the Commission, shall be responsible for calculating the annual and cumulative tonnages placed upon the Community market. If the tonnage thresholds detailed in Article 7 (2) are attained, the competent authority responsible for receiving the notification(s) shall contact each notifier informing them of the identity of the other notifiers and drawing their attention to their collective responsibility as outlined in Article 11. 5. The procedure laid down in Article 28 shall be followed confirming or amending proposals for classification and labelling. 6. Without prejudice to Article 19 (1), Member States and the Commission shall ensure that any information concerning commercial exploitation or manufacturing is kept secret. Article 17 Involvement of the Commission in the notification procedure When a Member State has received the notification dossier referred to in Articles 7 (1) and 8 (1), or information on the supplementary testing carried out in accordance with Articles 7 (2) and 8 (3), or follow-up information submitted in conformity with Article 14, it shall as soon as possible send the Commission a copy of the dossier or of the further information or a summary thereof. In the case of the further information referred to in Article 16 (1), the competent authority shall notify the Commission of the tests chosen, the reasons for their choice, the results and, if appropriate, an assessment of the results. In the case of information received in conformity with Article 13 (2), the competent authority shall forward to the Commission such elements as would be of common interest for the Commission and the other competent authorities. The assessment of the risks referred to in Article 16 (1) or a summary of that assessment shall be forwarded to the Commission as soon as it becomes available. Article 18 Duties of the Commission 1. On receipt of the dossiers and information referred to in Article 17, the Commission shall forward copies to the Member States. In addition, the Commission may also forward any other relevant information it has collected pursuant to this Directive, as it sees fit. 2. The competent authority of any Member State may consult directly the competent authority which received the original notification, or the Commission, on specific details of the data contained in the dossier required under this Directive or the assessment of the risks provided for in Article 16 (1); it may also suggest that further tests or information be requested or that the assessment of the risks be modified. If the competent authority which received the original notification fails to comply with the suggestions of other authorities regarding further information, confirmation tests or amendments in the study programmes provided for in Annex VIII or the assessment of the risks, it shall give its reasons to the other authorities concerned. Should it not be possible for the authorities concerned to reach agreement and should any one authority feel, on the basis of detailed reasons, that additional information, confirmation tests or amendments in the study programmes or an assessment are nevertheless really necessary to protect man and the environment, it may ask the Commission to take a decision in accordance with the procedure laid down in Article 29 (4) (b). Article 19 Confidentiality of data 1. If he considers that there is a confidentiality problem, the notifier may indicate the information provided for in Articles 7, 8 and 14 which he considers to be commercially sensitive and disclosure of which might harm him industrially or commercially, and which he therefore wishes to be kept secret from all persons other than the competent authorities and the Commission. Full justification must be given in such cases. With respect to the notifications and information submitted in conformity with Articles 7 (1) and (2), 8 (1), (2) and (3), industrial and commercial secrecy shall not apply to: (a) the trade name of the substance; (b) the name of the manufacturer and the notifier; (c) physico-chemical data concerning the substance in connection with section 3 of Annexes VII. A, VII. B and VII. C; (d) the possible ways of rendering the substance harmless; (e) the summary results of the toxicological and ecotoxicological tests; (f) if essential to classification and labelling for the purpose of introducing the substance into Annex I, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous within the meaning of Article 2 (2); (g) the recommended methods and precautions referred to in Annex VII, section 2.3, and the emergency measures referred to in Annex VII, sections 2.4 and 2.5; (h) the information contained in the safety data sheet; (i) in the case of substances in Annex I, analytical methods that make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans. If the notifier, manufacturer or importer should himself later disclose previously confidential information, he shall inform the competent authority accordingly. 2. The authority receiving the notification/ information shall decide on its own responsibility which information is covered by industrial and commercial secrecy in accordance with paragraph 1. Information accepted as being confidential by the authority receiving the notification dossier from the notifier shall be treated as being confidential by the other competent authorities and the Commission. 3. For substances appearing in the list provided for in Article 21 (1) and which are not classified as dangerous within the meaning of this Directive, the name may be included in the form of its trade name in those cases where the competent authority to which the notification has been submitted so requests. Normally, such substances may be included in the list in the form of their trade name for a maximum of three years. However, if the competent authority to which the dossier was submitted considers that the publication of the chemical name in the IUPAC nomenclature itself could reveal information concerning commercial exploitation or manufacture, the name of the substance may be recorded under its trade name alone for as long as that competent authority sees fit. Dangerous substances may, at the request of the competent authority receiving the notification, be entered on the list in the form of their trade names alone until such time as they are introduced into Annex I. 4. Confidential information brought to the attention either of the Commission or of a Member State shall be kept secret. In all cases such information: - may be brought to the attention only of the authorities whose responsibilities are specified in Article 16 (1), - may, however, be divulged to persons directly involved in administrative or legal proceedings involving sanctions which are undertaken for the purpose of controlling substances placed on the market and to persons who are to participate or be heard in legislative proceedings. Article 20 Exchange of the summary dossier 1. The data supplied in accordance with Articles 17 and 18 may be forwarded to the Commission and the Member States in summary form. In such cases and in the context of Article 18 (2), the competent authorities of a Member State and the Commission shall have access to the notification dossier and the additional information at all times. 2. For the purpose of the exchange of information referred to in Articles 17 and 18 (1), the Commission shall develop a common format. This format shall be adopted by the procedure laid down in Article 29. Article 21 Lists of existing and new substances 1. The Commission shall keep a list of all substances notified under this Directive. This list shall be compiled in accordance with the provisions of Commission Decision 85/71/EEC (32). 2. The Commission shall allocate an EEC number to each substance contained on the EINECS inventory and on the list referred to in paragraph 1. (33) OJ No L 30, 2. 2. 1985, p. 33. Article 22 Packaging 1. Member States shall take all necessary measures to ensure that dangerous substances cannot be placed on the market unless their packaging satisfies the following requirements: (a) it shall be so designed and constructed that its contents cannot escape; this requirement shall not apply where special safety devices are prescribed; (b) the materials constituting the packaging and fastenings must not be susceptible to adverse attack by the contents, or liable to form dangerous compounds with the contents; (c) packaging and fastenings must be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling; (d) containers fitted with replaceable fastening devices shall be so designed that the packaging can be refastened repeatedly without the contents escaping; (e) every container of whatever capacity, containing substances sold or made available to the general public and labelled "very toxic", "toxic" or "corrosive", as defined in this Directive, must have a child-resistant fastening and a tactile warning of danger; (f) every container, of whatever capacity, containing substances sold or made available to the general public and labelled "harmful", "extremely flammable" or "highly flammable" as defined in this Directive must bear a tactile warning of danger. 2. Member States may also prescribe that packaging shall be closed initially with a seal in such a way that when the packaging is opened for the first time the seal is irreparably damaged. 3. The categories of substances for which the packaging must be equipped with the devices mentioned in paragraph 1 (e) and (f) shall be modified in accordance with the procedure provided for in Article 29. 4. The technical specifications relating to the devices referred to in paragraph 1 (e) and (f) shall be modified in accordance with the procedure provided for in Article 29 (4) (a) and are to be found in points A and B of Annex IX to this Directive. Article 23 Labelling 1. Member States shall take all necessary measures to ensure that dangerous substances cannot be placed on the market unless the labelling on their packaging satisfies the following requirements. 2. Every package shall show clearly and indelibly the following: (a) the name of the substance under one of the designations given in Annex I. If the substance is not yet listed in Annex I, the name must be given using an internationally recognized designation; (b) the name and full address including the telephone number of the person established in the Community who is responsible for placing the substance on the market whether it be the manufacturer, the importer or the distributor; (c) danger symbols, when laid down, and indication of the danger involved in the use of the substance. The design of the danger symbols and the wording of the indications of danger shall comply with those laid down in Annex II (34). The symbol shall be printed in black on an orange-yellow background. The danger symbols and indications of danger to be used for each substance shall be those indicated in Annex I. For dangerous substances not yet appearing in Annex I the danger symbols and indications of danger shall be assigned according to the rules laid down in Annex VI. When more than one danger symbol is assigned to a substance: - the obligation to indicate the symbol T makes the symbols X and C optional, unless Annex I provides otherwise, - the obligation to indicate the symbol C makes the symbol X optional, - the obligation to indicate the symbol E makes the symbol F and O optional; (d) standard phrases (R-phrases) indicating the special risks arising from the dangers involved in using the substance. The wording of those R-phrases shall comply with that laid down in Annex III. The R-phrases to be used for each substance shall be as indicated in Annex I. For dangerous substances not yet appearing in Annex I the R-phrases to be used shall be assigned according to the rules laid down in Annex VI; (e) standard phrases relating to the safe use of the substance (S-phrases). The wording of these S-phrases shall comply with that laid down in Annex IV. The S-phrases to be used for each substance shall be as indicated in Annex I. For dangerous substances not yet appearing in Annex I, the S-phrase to be used shall be assigned according to the rules laid down in Annex VI; (f) the EEC number, when allocated. The EEC number shall be obtained from the EINECS or from the list referred to in Article 21 (1). In addition, as regards substances appearing in Annex I, the label shall also include the words "EEC label". 3. In the case of irritant, highly flammable, flammable and oxidizing substances, an indication of R-phrases and S-phrases need not be given where the package does not contain more than 125 ml. This shall also apply in the case of the same volume of harmful substances not retailed to the general public. 4. Indications such as "non-toxic", "non-harmful" or any other similar indications must not appear on the label or packaging of substances subject to this Directive. (35) See the following adaptations to technical progress: OJ No L 257, 16. 9. 1983, p. 1, OJ No L 247, 1. 9. 1986, p. 1. Article 24 Implementation of labelling requirements 1. Where the particulars required by Article 23 appear on a label, that label shall be firmly affixed to one or more surfaces of the packaging so that these particulars can be read horizontally when the package is set down normally. The dimensions of the label shall be as follows: Capacity of the package Dimensions (in millimetres) - not exceeding 3 litres at least 52 × 74 - greater than 3 litres but not exceeding 50 litres at least 74 × 105 - greater than 50 litres but not exceeding 500 litres at least 105 × 148 - greater than 500 litres at least 148 × 210 Each symbol shall cover at least one-tenth of the surface area of the label but not be less than 1 cm². The entire surface of the label shall adhere to the package immediately containing the substance. These dimensions are intended solely for provisions of the information required by this Directive and if necessary of any supplementary health or safety indications. 2. A label is not required where the particulars are clearly shown on the package itself, as specified in paragraph 1. 3. The colour and presentation of the label - or, in the case of paragraph 2, of the package - shall be such that the danger symbol and its background stand out clearly. 4. The information required on the label under Article 23 shall stand out clearly from its background and shall be of such size and spacing as to be easily read. Specific provisions regarding the presentation and dimensions of this information shall be laid down in Annex VI in accordance with the procedure referred to in Article 29 (4) (b). 5. Member States may make the placing on the market of dangerous substances in their territories subject to the use of the official language or languages in respect of the labelling thereof. 6. For the purpose of this Directive, labelling requirements shall be deemed to be satisfied: (a) in the case of an outer package containing one or more inner packages, if the outer package is labelled in accordance with international rules on the transport of dangerous substances and the inner package or packages are labelled in accordance with this Directive; (b) in the case of a single package: - if such a package is labelled in accordance with international rules on the transport of dangerous substances and with Article 23 (2) (a), (b), (d), (e) and (f), and - where appropriate, for particular types of packaging such as mobile gas cylinders, in accordance with the specific requirements referred to in Annex VI. Where dangerous substances do not leave the territory of a Member State, labelling may be permitted which complies with national rules instead of with international rules on the transport of dangerous substances. Article 25 Exemptions from labelling and packaging requirements 1. Articles 22, 23 and 24 shall not apply to the provisions governing munitions and explosives placed on the market with a view to producing a practical effect by explosion or a pyrotechnic effect. Nor shall the abovementioned Articles be applicable to the provisions relating to butane, propane and liquefied petroleum gas until 30 April 1997. 2. In addition, Member States may: (a) permit the labelling required by Article 23 to be applied in some other appropriate manner on packages which are either too small or otherwise unsuitable for labelling in accordance with Article 24 (1) and (2); (b) by way of derogation from Articles 23 and 24, permit the packaging of dangerous substances which are not explosive, very toxic or toxic to be unlabelled or to be labelled in some other way if they contain such small quantities that there is no reason to fear any danger to persons handling such substances or to other persons; (c) where packages are too small for the labelling provided for in Articles 23 and 24 and there is no reason to fear any danger to persons handling such substances or to other persons, by way of derogation from the above provisions, permit the packaging of explosive, very toxic or toxic substances to be labelled in some other appropriate way. This derogation does not permit use of symbols, indications of danger, risk (R) phrases or safety (S) phrases different from those laid down in this Directive. 3. If a Member State makes use of the options provided for in paragraph 2, it shall inform the Commission thereof forthwith. Article 26 Advertisement Any advertisement for a substance which belongs to one or more of the categories referred to in Article 2 (2) shall be prohibited if no mention is made therein of the category or categories concerned. Article 27 Safety data sheet 1. To enable professional users in particular to take the necessary measures as regards the protection of the environment and health and safety at the workplace, at, or if appropriate, before the first delivery of a dangerous substance, any manufacturer, importer or distributor shall communicate to the recipient a safety data sheet. This sheet must contain the information necessary for protection of man and the environment. It may be communicated on paper or electronically. Subsequently, the manufacturer, importer or distributor shall forward to the recipient of the safety data sheet any new relevant information on the substance which has become known to him. 2. General rules for the elaboration, distribution, contents and format of the safety data sheet referred to in paragraph 1 will be established in accordance with the procedure laid down in Article 29 (4) (a). Article 28 Adaptation to technical progress The amendments necessary for adapting the Annexes to technical progress shall be adopted in accordance with the procedure laid down in Article 29. Article 29 Procedure for adaptation to technical progress 1. The Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission. 2. The representative of the Commission 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. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. If 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 relating to the measures to be taken. The Council shall act by a qualified majority. 4. (a) Except in the cases referred to in subparagraph (b) below, if, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. This period shall be six weeks in the case referred to in Article 31 (2). (b) In the case of measures for adaptation to technical progress in Annexes II, VI, VII and VIII, if, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority. Article 30 Free movement clause Member States may not prohibit, restrict or impede the placing on the market of substances which comply with the requirements of this Directive, on grounds relating to notification, classification, packaging or labelling within the meaning of this Directive. Article 31 Safeguard clause 1. Where, in the light of new information, a Member States has justifiable reasons to consider that a substance, which has been accepted as satisfying the requirements of the Directive, nevertheless constitutes a danger for man or the environment, by reason of classification, packaging or labelling which is no longer appropriate, it may temporarily reclassify or, if necessary, prohibit the placing on the market of that substance or subject it to special conditions in its territory. It shall immediately inform the Commission and the other Member States of such action and give reasons for its decision. 2. The Commission shall take a decision in accordance with the procedure referred to in Article 29 (4) (a). 3. If, subsequent to the decision taken in accordance with paragraph 2, the Commission considers that for cases falling under paragraph 1 above, technical adaptations to the Annexes of this Directive are necessary, it shall take a decision on the matter in accordance with the procedure provided for in Article 29. Article 32 Reports 1. Every three years, Member States shall forward to the Commission a report on the implementation of this Directive in their respective territories. The first report shall be submitted three years after the implementation of this Directive. 2. Every three years, the Commission shall prepare a composite report based on the information referred to in paragraph 1, which shall be forwarded to the Member States.' 2. Articles 24, 25 and 27 shall become Articles 33, 34 and 35. 3. Annexes II, VI, VII and VIII are hereby amended as follows: - Annex II shall be amended by the addition of a symbol indicating danger for the environment as in Annex 1 to this Directive, - Annex VI, Part 1. A shall be replaced by Annex 2 to this Directive, - Annex VII shall be replaced by Annex 3 to this Directive, - Annex VIII shall be replaced by Annex 4 to this Directive. Article 2 The following Directives are hereby amended as follows: 1. Directive 73/173/EEC (36)(): - replace 'Article 6' by 'Article 23' in Article 5 (2) (c), - replace 'Article 8c' by 'Article 28' in Articles 9 (2) and 10; 2. Directive 77/728/EEC (37)(): - replace 'Article 6' by 'Article 23' in Article 6 (2) (c), - replace 'Article 8c' by 'Article 28' in Articles 10 (3) and 11; 3. Directive 78/631/EEC: - replace 'Article 6' by 'Article 23' in Article 6 (2) (g), - replace 'Article 8c' by 'Article 28' in Article 10 (3) and 11; 4. Directive 88/379/EEC: - replace the reference to Directive 79/831/EEC by a reference to the present Directive in the second and eighth recitals, - replace 'carcinogenic, mutagenic and teratogenic effects' by 'carcinogenic and mutagenic effects and effects on reproduction' in Article 3 (3), - replace 'Article 8 (2) of Directive 67/548/EEC' by 'Article 13 (3) of Directive 67/548/EEC' in Article 3 (5), - Article 3 (5) (o) shall read as follows: '(o) Preparations should be regarded as: toxic for reproduction and assigned at least the symbol and the indication of danger "toxic" if they contain a substance producing such effects which is assigned at least one of the R-phrases defined in Annex VI to Directive 67/548/EEC as characterizing substances as toxic for reproduction in category 1, in a concentration equal to or exceeding: - either the concentrations specified in Annex I to Directive 67/548/EEC for the substance under consideration, or - the concentration specified at point 6 of Annex I (Table VI) to this Directive where the substance or substances under consideration do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;', - Article 3 (5) (p) shall read as follows: '(p) Preparations shall be regarded as: having to be treated as toxic for reproduction and assigned at least the symbol and the indication of danger "toxic" if they contain a substance producing such effects which is assigned at least one of the R-phrases defined in Annex VI to Directive 67/548/EEC as characterizing substances as toxic for reproduction in category 2, in a concentration equal to or exceeding: - either the concentrations specified in Annex I to Directive 67/548/EEC for the substance under consideration, or - the concentration specified at point 6 of Annex I (Table VI) to this Directive where the substance or substances under consideration do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;', - Article 3 (5) (q) shall read als follows: '(q) Preparations shall be regarded as: having to be regarded as toxic for reproduction and assigned at least the symbol and the indication of danger "harmful" if they contain a substance producing such effects which is assigned at least one of the R-phrases defined in Annex VI to Directive 67/548/EEC as characterizing substances as dangerous for reproduction in category 3 in a concentration equal to or exceeding: - either the concentrations specified in Annex I to Directive 67/548/EEC for the substance under consideration, or - the concentration specified at point 6 of Annex I (Table VI) to this Directive where the substance or substances under consideration do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;', - replace 'Article 15 (1)' by 'Article 22 (1)' in Article 6 (1) (a), - replace 'Article 21' by 'Article 28' in Article 6 (3), - replace 'Article 11 (4)' by 'Article 19 (4)' in Article 7 (1) (c) (ii), - replace 'Article 16 (2) (c)' by 'Article 23 (2) (c)' in Article 7 (1), - the following paragraph shall be inserted in Article 8: '3a. The information required on the label under Article 7 shall stand out clearly from the background and shall be of such size and spacing as to be easily read. Specific provisions regarding the presentation and dimensions of this information shall be laid down in Annex VI to Directive 67/548/EEC in accordance with the procedure referred to in Article 28 (4) (b) of that Directive.', - replace 'Article 21' by 'Article 28' in Articles 10, 14 (2) and 15, - replace 'teratogenic effects' by 'effects on reproduction' in the title of Annex I, Part 6, - replace 'teratogenic substances' by 'substances toxic for reproduction' in Annex I, Table VI. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 October 1993. They shall forthwith inform the Commission therof. 2. When these measures are adopted by Member States, 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. 3. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. Article 4 This Directive is addressed to the Member States.

31992L0037

1992

Commission Directive 92/37/EEC of 30 April 1992 adapting to technical progress for the sixteenth time Council Directive 67/548/EEC on the approximation of the laws, Regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as last amended by Directive 92/32/EEC (2), and in particular Article 19 thereof, Whereas Annex I to Directive 67/548/CEE contains a list of dangerous substances, together with particulars of the classification and labelling procedures in respect of each substance; whereas examination of the list of the notified dangerous substances in Annex I has shown that this list needs to be adapted in the light of present scientific and technical knowledge; whereas it is necessary to add to this list a number of substances notified to the Commission in accordance with the Directive; Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directive for the Elimination of Technical Barriers to Trade in Dangerous Substances and Preparations, Article 1 Annex I of Directive 67/548/EEC is hereby amended as follows: 1. The entries in Annex I to this Directive replace the corresponding entries in Annex I. 2. The entries in Annex II to this Directive are included for the first time in Annex I. Article 2 1. Not later than 1 November 1993 the Member States shall implement the laws, regulations and administrative provisions necessary to comply with this Directive. Member States shall immediately inform the Commission thereof. 2. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

31992L0039

1992

Commission Directive 92/39/EEC of 14 May 1992 amending Directive 90/128/EEC relating to plastics materials and articles intended to come into contact with foodstuffs Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (1), and in particular Article 3 thereof, Whereas Commission Directive 90/128/EEC (2) of 23 February 1990, and in particular Article 3 (4), provides for the revision of Annex II and particularly section B; Whereas, on the basis of the available information, certain substances provisionally admitted at national level may be included in the Community list, while others must be definitively prohibited; Whereas certain substances provisionally admitted at national level may continue to be permitted for a further specified period since the data requested by the Scientific Committee for Food are not yet available but the required studies are ongoing or are planned; Whereas other substances have been requested for use following the adoption of the Directive, and the technical data supplied permit their inclusion in the Community list; Whereas, for certain substances, the restrictions already set out should be amended according to the available information; Whereas it is necessary to permit the continued use of certain well-defined substances contained in those groups of substances which are not well-defined and are now deleted, pending a decision on their inclusion in the Community list; Whereas the Scientific Committee for Food has been consulted; Whereas the measures laid down by this Directive comply with the opinion of the Standing Committee on Foodstuffs, Article 1 Directive 90/128/EEC is hereby amended as follows: 1. Article 3 (4) is replaced by the following: '4. As from 1 January 1997, only those monomers and other starting substances listed in Annex II, Section A, shall be used for the manufacture of plastic materials and articles, subject to the restrictions specified therein. However, the substances listed in Annex II, Section B may be deleted before the abovementioned date if the data requested for inclusion in Section A are not supplied in time to permit their evaluation by the Scientific Committee for Food. Moreover, before 1 January 1996 it may be decided that, in some justified cases, for certain substances listed in Annex II, Section B, this time-limit will be postponed.' 2. Annex II of Directive 90/128/EEC is amended as follows: (a) Section A: - the substances appearing in Annex I to this Directive are added; - the content of the column 'Restrictions' for the substances appearing in Annex II of this Directive is modified as indicated therein. (b) Section B: - the substances appearing in Annex III to this Directive are added, as a replacement for those groups of substances which are not well-defined and which are deleted by this Directive; - the substances appearing in Annex IV to this Directive are deleted; - the content of the column 'Restrictions' for the substance appearing in Annex V to this Directive is modified as indicated therein. (c) The substances appearing in Annex VI to this Directive are transferred from Section B to A and are now subject to the restrictions, if any, specified. (d) Point 8 is hereby amended as follows: - the following text is inserted after 'NCO = isocyanate moiety;' 'ND = not detectable. For the purpose of this Directive "not detectable" means that the substance should not be detected by a validated method of analysis which should detect it at the detection limit (DL) specified. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the detection limit may be used, pending the development of a validated method.' - the following text is inserted after 'SML = specific migration limit in food or in food stimulant, unless it is specified otherwise.' 'For the purpose of this Directive "SML" means that the specific migration of the substance should be determined by a validated method of analysis at the specified limit. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method.' Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1992. They shall immediately inform the Commission thereof. Member States should: - permit trade in and use of plastic materials and articles complying with this Directive by 31 March 1994; - prohibit trade in and use of plastic materials and articles intended to come into contact with foodstuffs and which do not comply with this Directive with effect from 1 April 1995. 2. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

31992L0041

1992

Council Directive 92/41/EEC of 15 May 1992 amending Directive 89/622/EEC on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products 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 their labelling; Whereas such common rules must take due account of public health protection, and of the protection of young persons in particular, taking as a base of high level of health protection, according to Article 100a (3) of the Treaty; 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, for the purposes of providing objective information on the risks entailed in tobacco consumption, Council Directive 89/622/EEC (5) established a general warning to be carried on the unit packaging of all tobacco products, together with additional warnings exclusively for cigarettes; Whereas the Commission, at the request of the Council, undertook to propose an amendment to Directive 89/622/EEC so as to establish additional specific warnings to be carried on the unit packaging of tobacco products other than cigarettes; Whereas scientific experts are of the opinion that all tobacco products carry health risks; Whereas, in relation to their effects on health and for the purposes of their labelling, a distinction needs to be made between smoking tobacco products and smokeless tobacco products; Whereas rolling tobaccos carry the same health risks as cigarettes and it is therefore appropriate that the specific warnings selected for cigarettes should apply also to rolling tobaccos; Whereas other smoking tobacco products carry similar health risks to those carried by cigarettes; whereas, however, the range of such products is more varied; whereas such products should therefore be required to carry specific warning which accord with appropriate rules; Whereas it has been proved that smokeless tobacco products are a major risk factor as regards cancer and whereas they should therefore carry a specific warning of that risk; Whereas scientific experts are of the opinion that the addiction caused by tobacco consumption constitutes a danger meriting a specific warning on every tobacco product; Whereas, moreover, new tobacco products for oral use which have appeared on the market in certain Member States are particularly attractive to young people and whereas the Member States most exposed to this problem have already placed total bans on these new tobacco products or intend so to do; Whereas, regarding such products, there are differences between the laws, regulations and administrative provisions of the Member States and whereas these products therefore need to be made subject to common rules; Whereas there is a real risk that the new products for oral use will be used above all by young people, thus leading to nicotine addiction, unless restrictive measures are taken in time; Whereas, in accordance with the conclusions of the studies conducted by the International Agency for Research on Cancer, tobacco for oral use contains particularly large quantities of carcinogenic substances; whereas these new products cause cancer of the mouth in particular; Whereas, the sales bans on such tobacco already adopted by three Member States have a direct impact on the establishment and operation of the internal market; whereas it is therefore necessary to approximate Member States' laws, regulations and administrative provisions in this area, taking as a base a high level of health protection; whereas the only appropriate measure is a total ban; whereas, however, such a ban should not affect traditional tobacco products for oral use, which will remain subject to the provisions of Directive 89/622/EEC, as amended by this Directive, applicable to smokeless tobacco products; 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, Article 1 Directive 89/622/EEC is hereby amended as follows: 1. The following shall be added to the title and to Article 1: 'and the prohibition of the marketing of certain types of tobacco for oral use.' 2. The following point shall be added to Article 2: '4. "Tobacco for oral use", for the purposes of Article 8a, means all products for oral use, except those intended to be smoked or chewed, made wholly or partly of tobacco, in powder or particulate form or in any combination of these forms - particularly those presented in sachet portions or porous sachets - or in a form resembling a food product.' 3. Article 4 shall be amended as follows: (a) in paragraph 2 the word 'Annex' shall be replaced by 'Annex I'; (b) the following paragraph shall be inserted: '2a. In addition to the general warning referred to in paragraph 1, unit packets of tobacco products other than cigarettes shall carry specific warnings which accord with the following rules: (a) on the other large surface of rolling tobacco packets, the specific warnings, of which each Member State shall draw up a list taken exclusively from the warnings listed in Annex I, shall be rotated in such a way as to guarantee the successive appearance of each warning on an equal quantity of unit packets, with a tolerance of approximately 5 %; (b) unit packets of cigars, cigarillos, pipe tobacco or other smoking tobacco products with the exception of cigarettes and rolling tobacco shall carry a specific warning from among those in Annex II, in such a way as to ensure that they are in actual fact rotated; (c) unit packets of smokeless tobacco products shall carry the following specific warning: "Causes cancer". The specific warnings shall be printed on, or irremovably affixed to, the unit packets in the official language or languages of the country of final marketing.' (c) paragraph 3 shall be replaced by the following: '3. Member States may stipulate that the warnings referred to in paragraphs 1, 2 and 2a be combined with the indication of the authority that is their author.' (d) paragraph 5 shall be replaced by the following: '5. On tobacco products other than cigarettes, the general warning provided for in paragraph 1 and the specific warning provided for in paragraph 2a shall be printed or irremovably affixed. Each warning must, in each language used, cover at least 1 % of the total surface of the unit packet. It must, in any event, be easily visible, clearly legible and indelible. The warnings must appear in a conspicuous place on a contrasting background and must not in any way be hidden, obscured or interrupted by other written or pictorial matter.' 4. Article 5 shall be replaced by the following: 'Article 5 The Commission shall adapt to technical progress, in accordance with Articles 6 and 7, the measurement and verification methods referred to in Article 3 (1) and (2) and, if necessary, the definitions referred to in Article 2 (2) and (3).' 5. The following Article shall be inserted: 'Article 8a Member States shall prohibit the placing on the market of tobacco for oral use as defined in Article 2 (4).' 6. The Annex shall be replaced by those attached to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions to comply with this Directive not later than 1 July 1992. They shall immediately inform the Commission thereof and shall communicate to it the essential provisions of national law they have adopted in the field covered by this Directive. When Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States. 2. The amendment to Directive 89/622/EEC referred to in Article 1 (5) become applicable not later than 1 July 1992. The amendments to Directive 89/622/EEC referred to in Article 1 (3), (4) and (6) shall become applicable not later than 1 January 1994. However, products existing at that date which do not comply with the requirements of Article 4 (2a), (3) and (5) of Directive 89/662/EEC may still be marketed until 31 December 1994. Article 3 1. The Commission shall publish in the Official Journal of the European Communities the national lists of warnings provided for in Article 4 (2a) (a) of Directive 89/662/EEC for rolling tobacco. 2. Member States which, after 31 December 1993, amend their list of warnings as referred to in paragraph 1 shall notify such amendment, eighteen months before its application, to the Commission, which shall publish it in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31992L0040

1992

Council Directive 92/40/EEC of 19 May 1992 introducing Community measures for the control of avian influenza Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 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 poultry is listed in Annex II of the Treaty; whereas the marketing of poultry constitutes an important source of revenue for the agricultural population; Whereas, it is necessary to establish at Community level the control measures to be taken in the event of outbreak of the highly pathogenic form of avian influenza, caused by an influenza virus with specific characteristics, and hereinafter termed avian influenza, in order to ensure national development of the poultry sector and contribute to the protection of animal health in the Community; Whereas an outbreak of avian influenza can quickly take on epizootic proportions, causing mortality and disturbances on a scale liable to reduce sharply the profitability of farming or poultry as a whole; Whereas action must be taken as soon as the presence of the disease is suspected so that immediate and effective control measures can be implemented when its presence is confirmed; Whereas it is necessary to prevent any spread of the disease as soon as an outbreak occurs, by carefully monitoring movements of animals and the use of products liable to be contaminated, and where appropriate, by vaccination; Whereas diagnosis of the disease must be carried out under the auspices of responsible national laboratories, the coordination of which must be ensured by the Community reference laboratory; Whereas common measures for the control of avian influenza form a basis for maintaining a unified standard with relation to animal health; Whereas Article 3 of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (4) applies in the event of the occurrence of avian influenza; Whereas it is appropriate to confer upon the Commission the task of taking the necessary applicatory measures, Article 1 This Directive defines the Community control measures to be applied in the event of an outbreak of avian influenza in poultry without prejudice to the Community provisions governing intra-Community trade. This Directive shall not apply where avian influenza is detected in other birds; however, in this case, the Member State concerned shall inform the Commission of any measure it takes. Article 2 For the purpose of this Directive, the definitions given in Article 2 of Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (5) shall apply as appropriate. The following definitions shall also apply: (a) infected poultry shall mean any poultry: - in which the presence of avian influenza, within the meaning of Annex I, has been officially confirmed following an examination by an approved laboratory, or - in the case of second and subsequent outbreaks, in which clinical signs or post-mortem lesions consistent with avian influenza are present; (b) poultry suspected of being infected shall mean any poultry showing clinical signs or post-mortem lesions which are such that the presence of avian influenza may reasonably be suspected or any poultry in which the presence of influenza A virus of subtype H5 or H7 has been demonstrated; (c) poultry suspected of being contaminated shall mean any poultry which may have been directly or indirectly exposed to the avian influenza virus, or influenza A virus of H5 subtype or H7 subtype; (d) competent authority shall mean the competent authority within the meaning of Article 2 (6) of Directive 90/425/EEC (6); (e) official veterinarian shall mean the veterinarian designated by the competent authority. Article 3 Member States shall ensure that there is compulsory and immediate notification of the suspected presence of avian influenza to the competent authority. Article 4 1. When poultry in a holding are suspected of being infected or contaminated with avian influenza, Member States shall ensure that the official veterinarian immediately activates official investigation arrangements to confirm or rule out the presence of the disease and, in particular, must take or have taken the samples necessary for laboratory examination. 2. As soon as the suspected infection is notified, the competent authority shall have the holding placed under official surveillance and shall in particular require that: (a) a record be made of all categories of poultry on the holding showing in respect of each of the categories the numbers of poultry which have died, which show clinical signs, and which show no signs. The record shall be kept up-to-date to include birds born or dying during the period in which there is a suspicion. The data in the record shall be kept up-to-date and be produced on request, and may be checked at each visit; (b) all poultry on the holding are kept in their living quarters or confined in some other place where they can be isolated and without contact with other poultry; (c) no poultry enter or leave the holding; (d) all movement - of persons, other animals and vehicles to or from the holding, - of poultry meat or carcases, or of animal feed, implements, waste, droppings, manure litter or anything liable to transmit avian influenza be subject to authorization by the competent authority; (e) eggs shall leave the holding with the exception of eggs sent directly to an establishment approved for the manufacture and/or processing of egg products under Article 6 (1) of Directive 89/437/EEC (7), and transported under an authorization which has been granted by the competent authority. Such authorization must meet the requirements laid down in Annex I; (f) appropriate means of disinfection be used at the entrances and exits of buildings housing poultry and of the holding itself; (g) an epizootiological inquiry be carried out in accordance with Article 7. 3. Until such time as the official measures laid down in paragraph 5 are enforced, the owner or keeper of any poultry in which disease is suspected shall take all reasonable action to ensure compliance with paragraph 2, except for (g) thereof. 4. The competent authority may apply any of the measures provided for in paragraph 2 to other holdings should their location, their configuration or contacts with the holding where the disesase is suspected give reason to suspect possible contamination. 5. The measures referred to in paragraphs 1 and 2 shall not be withdrawn until the suspicion of avian influenza has been ruled out by the official veterinarian. Article 5 1. Once the presence of avian influenza has been officially confirmed on a holding, the Member States shall ensure that the competent authority requires, in addition to the measures listed in Article 4 (2), the following measures to be undertaken: (a) all poultry on the holding shall without delay be killed on the spot. The poultry which have died or been killed and all eggs shall be destroyed. These operations shall be carried out in a way which minimizes the risk of spreading disease; (b) any substance or waste, such as animal feed, litter or manures liable to be contaminated, shall be destroyed or treated appropriately. This treatment, carried out in accordance with the instructions of the official veterinarian, shall ensure the destruction of any avian influenza virus present; (c) where poultry from the holding have been slaughtered during the presumed incubation period of disease the meat from those poultry shall wherever possible be traced and destroyed; (d) hatching eggs laid during the presumed incubation period which have been moved from the holding shall be traced and destroyed; but poultry which have already hatched from the eggs shall be placed under official surveillance; table eggs laid during the presumed incubation period which have been moved from the holding shall whereever possible be traced and destroyed, unless they have previously been properly disinfected; (e) after carrying out operations listed in subparagraphs (a) and (b) the buildings used for housing poultry, their surroundings, the vehicles used for transport and all equipment likely to be contaminated shall be cleaned and disinfescted in accordance with the provisions of Article 11; (f) no poultry shall be reintroduced to the holding until at least 21 days after completion of operations provided for in subparagraph (e); (g) an epizootiological inquiry shall be carried out in accordance with Article 7. 2. The competent authority may extend the measures provided for in paragraph 1 to other neighbouring holdings should their location, their configuration, or contact with the holding where the disease has been confirmed give reason to suspect possible contamination. Article 6 In the case of holdings which consist of two or more separate flocks, the competent authority may, in accordance with criteria set by the Commission under the procedure laid down in Article 21, grant a derogation from the requirements of Article 5 (1), for healthy flocks of a holding which is infected, provided that the official veterinarian has confirmed that the operations carried out there are such that the flocks are completely separate as regards housing, keeping and feeding, so that the virus cannot spread from one flock to another. Article 7 1. The epizootiological inquiry shall deal with: - the length of time during which avian influenza may have existed on the holding, - the possible origin of the avian influenza on the holding and the identification of other holdings on which there are poultry which may have become infected or contaminated from the same source, - the movement of persons, poultry or other animals, vehicles, eggs, meat and carcases and any implement or substance likely to have carried avian influenza virus to or from the holding in question. 2. In order to provide full coordination of all measures necessary to ensure eradication of avian influenza as quickly as possible and for the purpose of carrying out the epidemiological inquiry, a crisis unit shall be established. The general rules concerning national crisis units and Community crisis units will be laid down by the Council, acting by a qualified majority proposal from the Commission. Article 8 1. Where the official veterinarian has reason to suspect that poultry on any holding may have been contaminated as a result of the movement of persons, animals or vehicles or in any other way, that holding shall be placed under official control in accordance with paragraph 2. 2. The purpose of the official control shall be to detect immediately any suspicion of avian influenza, count the poultry and monitor their movements and, where appropriate, to take the action provided for in paragraph 3. 3. When a holding is subject to the official control under paragraphs 1 and 2, the competent authority shall prohibit removal of poultry from the holding other than for transport directly to a slaughterhouse under official supervision for the purpose of immediate slaughter. Before granting such authorization, the official veterinarian must have carried out a clinical examination of all the poultry to exclude presence of avian influenza on the holding. The movement restrictions referred to in this Article shall be imposed for a period of 21 days from the latest date of potential contamination; however, such restrictions must apply for a period of at least seven days. 4. Where it considers that conditions permit, the competent authority may limit the measures provided for in this Article to a part of the holding and to the poultry contained therein, provided that the poultry there have been housed, kept and fed completely separately by separate staff. Article 9 1. Once the diagnosis of avian influenza has been officially confirmed, the Member States shall ensure that the competent authority establishes around the infected holding a protection zone based on a minimum radius of three kilometres, itself contained in a surveillance zone based on a minimum radius of 10 kilometres. The establishment of the zones must take account of geographical, administrative, ecological and epizootiological factors relating to avian influenza, and of monitoring facilities. 2. The measures applied in the protection zone shall include: (a) the identification of all holdings having poultry whithin the zone; (b) periodic visits to all the holdings having poultry, a clinical examination of those poultry including, if necessary, the collection of samples for laboratory examination; a record of visits and findings must be kept; (c) the keeping of all poultry in their living quarters or some other place where they can be isolated; (d) the use of appropriate means of disinfection at the entrances and exits of the holding; (e) the control of movements of persons handling poultry, poultry carcases and eggs and vehicles carrying poultry, carcases and eggs within the zone; in general, transport of poultry shall be prohibited, except for transit by major highways or railways; (f) a prohibition on removing poultry and hatching eggs from the holding on which they are kept unless the competent authority has authorized the transport; (i) of poultry for immediate slaughter to a slaughterhouse preferably located in the infected area or, if that is not possible, to a slaughterhouse designated by the competent authority outside the infected area. The special health mark provided for in Article 5 (1) of Directive 91/494/EEC (8) must be applied to this poultrymeat; (ii) of day-old chicks or ready-to-lay pullets to a holding within the surveillance zone at which there are no other poultry. This holding must be placed under the official control provided for in Article 8 (2); (iii) of hatching eggs to a hatchery designated by the competent authority; before dispatch, eggs and their packing must be disinfected. Movements allowed in (i), (ii) and (iii) shall be directly executed, under official control. They shall be authorized only after the official veterinarian has carried out a health inspection of the holding. The means of transport used must be cleaned and disinfected before and after use; (g) a prohibition on removing or spreading used litter or poultry manure without authorization; (h) the prohibition of fairs, markets, shows or other gatherings of poultry or other birds. 3. The measures applied in the protection zone shall be maintained for at least 21 days after the carrying out of preliminary cleaning and disinfection operations on the infected holding in accordance with Article 11. The protection zone shall thereafter be part of the surveillance zone. 4. The measures applied in the surveillance zone shall include: (a) the identification of all holdings having poultry within the zone; (b) the control of poultry and hatching egg movement within the zone; (c) a prohibition on the movement of poultry out of the zone during the first 15 days, except for movement directly to a slaughterhouse outside the surveillance zone designated by the competent authority. The special health mark provided for in Article 3 of Directive 91/494/EEC must be applied to this poultry meat; (d) a prohibition on the movement of hatching eggs out of the surveillance zone unless to a hatchery designated by the competent authority. Before dispatch the eggs and their packing must be disinfected; (e) a prohibition on the movement of used litter or poultry manure out of the zone; (f) a prohibition of fairs, markets, shows or other gatherings of poultry and other birds; (g) without prejudice to the provisions of (a) and (b), the prohibition of transport of poultry except for transit by major highways or railways. 5. The measures applied in the surveillance zone shall be maintained for at least 30 days after the carrying out of preliminary cleaning and disinfection operations on the infected holding in accordance with Article 11. 6. Where the zones are situated in the territory of more than one Member State, the competent authorities of the Member States concerned shall cooperate in establishing the areas described in paragraph 1. However, if necessary, the protection zone and the surveillance zone shall be established by the procedure provided for in Article 21. Article 10 Member States shall ensure that: (a) the competent authority determines the arrangements allowing them to trace the movement of eggs and poultry; (b) the owner or keeper of poultry is required to supply the competent authority, in response to any request by that authority, with information concerning poultry and eggs entering or leaving his holding; (c) all persons engaged in the transport or marketing of poultry and eggs are able to supply the competent authority with information concerning the movements of poultry and eggs which they have transported or marketed and to furnish all the details concerning such information. Article 11 Member States shall ensure that: (a) the disinfectants to be used and their concentrations are officially approved by the competent authority; (b) the cleaning and disinfection operations are carried out under official supervision, in accordance with: (i) instructions given by the official veterinarian, (ii) the procedure for cleaning and disinfecting an infected holding, as laid down in Annex II. Article 12 Collection of samples and laboratory testing to detect the presence of avian influenza virus shall be carried out in accordance with Annex III. Article 13 Member States shall ensure that the competent authority takes all the necessary measures for persons established in the protection and surveillance zones to be informed of the restrictions in force and make all necessary arrangements for the appropriate implementation of the measures in question. Article 14 1. Member States shall ensure that, in each Member State there is designated: (a) a national laboratory at which facilities and expert personnel shall be maintained to permit assessment of the pathogenicity of influenza virus isolates, in accordance with Annex III, Chapter 7, and identification of influenza A viruses of H5 or H7 subtypes; (b) a national laboratory at which reagents for use in regional laboratories are tested; (c) a national institute or laboratory at which authorized vaccines may be tested in order to verify their conformity with the specifications laid down in the marketing authorization. 2. The national laboratories listed in Annex IV shall be responsible for coordinating standards and methods of diagnosis, use of reagents and testing of vaccines. 3. The national laboratories listed in Annex IV shall be responsible for coordinating the standards and diagnostic methods laid down in each avian influenza diagnostic laboratory within the Member State. To this end: (a) they may provide diagnostic reagents to national laboratories; (b) they shall control the quality of all diagnostic reagents used in that Member State; (c) they shall arrange comparative tests periodically; (d) they shall hold isolates of avian influenza virus from cases confirmed in that Member State; (e) they shall ensure the confirmation of positive results obtained in regional diagnostic laboratories. 4. The national laboratories listed in Annex IV shall liaise with the Community reference laboratory referred to in Article 15. Article 15 The Community reference laboratory for avian influenza is mentioned in Annex V. Without prejudice to the provisions of Decision 90/424/EEC, and in particular Article 28 thereof, the powers and duties of the laboratory shall be those appearing in the said Annex. Article 16 Vaccination against avian influenza with vaccines authorized by the competent authority may only be used to supplement the control measures carried out when the disease appears and in accordance with the following provisions: (a) the decision to introduce vaccination to supplement control measures shall be taken by the Commission in collaboration with the Member State concerned, acting in accordance with the procedure laid down in Article 21. This decision shall have particular regard to: - the concentration of poultry in the affected area, - the characteristics and composition of the vaccine to be used, - the procedures for supervision of the distribution, storage and use of vaccines, - the species and categories of poultry which shall be subject to vaccination, - the areas in which vaccination shall be carried out. However, by way of derogation from the first subparagraph, the decision to introduce emergency vaccination around the outbreak may be taken by the Member State concerned, following notification to the Commission, provided the fundamental interests of the Community are not jeopardized. Such decision will be re-examined immediately within the Standing Veterinary Committee in accordance with the procedure provided for in Article 21; (b) where a Member State is authorized, in accordance with point (a), to have recourse to emergency vaccination on a limited part of its territory the status of the remainder of the territory shall not be affected, provided that the immobilization measures for the vaccinated animals are effective during a period to be determined in accordance with the procedure laid down in Article 21. Article 17 1. Each Member State shall draw up a contingency plan, specifying the national measures to be implemented in the event of an outbreak of avian influenza. This plan must allow access to facilities, equipment, personnel and all other appropriate materials necessary for the rapid and efficient eradication of the outbreak. 2. The criteria to be applied for drawing up the plan are laid down in Annex VI. 3. Plans drawn up in accordance with the criteria listed in Annex VI shall be submitted to the Commission not later than six months after this Directive is brought into application. 4. The Commission shall examine the plans in order to determine whether they permit the desired objective to be attained and shall suggest to the Member State concerned any amendments required in particular to ensure that they are compatible with those of the other Member States. The Commission shall approve the plans, if necessary amended, in accordance with the procedure laid down in Article 21. The plans may subsequently be amended or supplemented, in accordance with the same procedure, to take into account developments in the situation. Article 18 1. Commission experts may, in collaboration with the competent authorities, and insofar as is necessary to ensure uniform application of this Directive, make on-the-spot checks. In order to do this, they may check a representative percentage of establishments to see whether the competent authorities are checking that these establishments are fulfilling the requirements of this Directive. The Commission shall inform the Member States of the result of the checks carried out. A Member State in whose territory a check is being carried out shall give all the necessary assistance to the experts in carrying out their duties. The general provisions for implementing this Article shall be determined in accordance with the procedure laid down in Article 21. Article 19 The detailed conditions governing the Community's financial contribution to the measures connected with the application of this Directive are laid down in Decision 90/424/EEC. Article 20 The Annexes shall be amended, as and when required, by the Council acting by a qualified majority acting on a proposal from the Commission in particular in order to take into account developments in research and in diagnostic procedures. Article 21 1. Where the procedure laid down in this Article is to be followed, the Standing Veterinary Committee, set up by Decision 68/361/EEC (9), hereinafter referred to as the 'the Committee', shall be informed without delay by its Chairman either on his own initiative or at the request of the representative of a Member State. 2. The representative of the Commission shall submit to the committee a draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. (b) If 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 relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission save where the Council has decided against the said measures by a simple majority. Article 22 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1993. 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. Article 23 This Directive is addressed to the Member States.

31992L0042

1992

Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels 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 Decision 91/565/EEC (4) provides for the promotion of energy efficiency in the Community under the SAVE programme; Whereas it is important to promote measures aimed at the progressive establishement of the internal market in the period up to 31 December 1992; whereas the internal market encompasses an area without internal frontiers, in which the free circulation of goods, persons, services and capital is assured; Whereas the Council resolution of 15 January 1985 on the improvement of energy-saving programmes in the Member States (5) invites Member States to pursue and where necessary increase their efforts to promote the more rational use of energy by the further development of integrated energy-saving policies; Whereas the Council resolution of 16 September 1986 concerns new Community energy-policy objectives for 1995 and convergence of the policies of the Member States (6), and in particular the objective of improving the efficiency of final energy demand by at least 20 %; Whereas Article 130r of the Treaty provides that action by the Community relating to the environment shall have the objective of ensuring a prudent and rational utilization of natural resources; Whereas it is appropriate to take as a base a high level of protection in proposals for the approximation of the provisions laid down by law, regulation or administrative action in Member States and concerning health, safety, environmental protection and consumer protection; Whereas the Council resolution of 21 June 1989 declares 'that the Community should take proper account of potential climatic change linked to the greenhouse effect' (7) and the Council's conclusions of 29 October 1990 state that CO2 emissions in the year 2000 should be stabilized throughout the Community at their 1990 level; Whereas the importance of the domestic and tertiary sector, which absorbs a major proportion of the final consumption of energy in the Community, is considerable; Whereas this sector will become even more important through trends towards more central heating and a general increase in thermal comfort; Whereas better boiler efficiency is in the consumer's interest; whereas energy saving will be reflected in fewer imports of hydrocarbons; whereas reduction in the Community's energy dependence will have a positive impact on its trade balance; Whereas Council Directive 78/170/EEC of 13 February 1978 on the performance of heat generators for space heating and the production of hot water in new or existing non-industrial buildings and on the insulation of heat and domestic hot-water distribution in new non-industrial builings (8), has given rise to the establishment of substantially different efficiency levels between one Member State and another; Whereas the requirement of high efficiency for hot-water boilers will reduce the range of technical properties of equipment placed on the market, thus facilitating series production and making for economies of scale; whereas the absence of a measure laying down energy requirements at a sufficiently high level may result, with the completion of the internal market, in a significant drop in the efficiency levels of heating installations through the spread on the market of low-efficiency boilers; Whereas local climatic conditions and the energy and occupancy characteristics of buildings differ greatly within the Community; whereas Member States must take this diversity into account when determining the conditions for putting boilers into service in implementation of this Direcitve; whereas these circumstances justify the fact that Member States where back-boilers and boilers designed to be installed in the living space are widely installed at the date of the adoption of this Directive should continue to authorize, within specific limits, the placing on their markets and the putting into service of such boilers; whereas these arrangements should be subject to particular surveillance by the Commission; Whereas this Directive, which is aimed at eliminating technical barriers with regard to boiler efficiency, must follow the new approach established by the Council resolution of 7 May 1985 (9) which specifically lays down that legislative harmonization is limited to the adoption, by means of directives based on Article 100 of the EEC Treaty, of the essential requirements with which products put on the market must conform and that 'these essential requirements shall be worded precisely enough in order to create legally binding obligations which can be enforced and to enable the certification bodies to certify products as being in conformity, having regard to those requirements in the absence of standards'; Having regard to Directive 83/189/EEC (10) laying down a procedure for the provision of information in the field of technical standards and regulations; Having regard to Decision 90/683/EEC (11) concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonization directives; Whereas boilers complying with the efficiency requirements should bear the CE mark and, where appropriate, signs in order to enable them to move freely and to be put into service in accordance with their intended purpose within the Community; Having regard to Directive 89/106/EEC (12) on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products; Whereas efficiency requirements to encourage the rational use of energy as laid down in Council Directive 90/396/EEC of 29 June 1990 on the approximation of the laws of the Member States relating to appliances burning gaseous fuels (13) should be established for the gas boilers referred to in this Directive, Article 1 This Directive, which comes under the SAVE programme concerning the promotion of energy efficiency in the Community, determines the efficiency requirements applicable to new hot-water boilers fired by liquid or gaseous fuels with a rated output of no less than 4 kW and no more than 400 kW, hereinafter called 'boilers'. Article 2 For the purposes of this Directive: - boiler: the combined boiler body-burner unit, designed to transmit to water the heat released from burning, - appliance: - the boiler body designed to have a burner fitted, - the burner designed to be fitted to a boiler body, - effective rated output (expressed in kW): the maximum calorific output laid down and guaranteed by the manufacturer as being deliverable during continuous operation while complying with the useful efficiency indicated by the manufacturer, - useful efficiency (expressed in %): the ratio between the heat output transmitted to the boiler water and the product of the net calorific value at constant fuel pressure and the consumption expressed as a quantity of fuel per unit time, - part load (expressed in %): the ratio between the effective output of a boiler operating intermittently or at an output lower than the effective rated output and the same effective rated output; - average temperature of the boiler water: the average of the water temperatures at the entry and exit of the boiler, - standard boiler: a boiler for which the average water temperature can be restricted by design, - back-boiler: a boiler designed to supply a central-heating system and to be installed in a fireplace recess as part of a back boiler/gas fire combination, - low-temperature boiler: a boiler which can work continuously with a water supply temperature of 35 to 40o C, possibly producing condensation in certain circumstances, including condensing boilers using liquid fuel, - gas condensing boiler: a boiler designed to condense permanently a large part of the water vapour contained in the combustion gases, - boiler to be installed in the living space: a boiler with an effective rated output of less than 37 kW, designed to provide heat to the part of the living space in which it is installed by means of the emission of heat from the casing having an open expansion chamber, supplying hot water using gravity circulation; such boilers shall bear on their casings the explicit indication that they must be installed in living space. Article 3 1. The following shall be excluded from this Directive: - hot-water boilers capable of being fired by different fuels including solid fuels, - equipment for the instantaneous preparation of hot water, - boilers designed to be fired by fuels the properties of which differ appreciably from the properties of the liquid and gaseous fuels commonly marketed (industrial waste gas, biogas, etc), - cookers and appliances designed mainly to heat the premises in which they are installed and, as a subsidiary function, to supply hot water for central heating and sanitary hot water, - appliances with rated outputs of less than 6 kW using gravity circulation and designed solely for the production of stored sanitary hot water, - boilers manufactured on a one-off basis. 2. In the case of boilers with a dual function, that of heating premises and also providing sanitary hot water, the efficiency requirements referred to in Article 5 (1) concern the heating function only. Article 4 1. Member States may not prohibit, restrict or impede the placing on the market or entry into service within their territories of appliances and boilers which satisfy the requirements of this Directive, save as otherwise laid down in the Treaty or other Directives or Community provisions. 2. Member States shall take all necessary measures to ensure that boilers cannot be put into service unless they satisfy the efficiency requirements set out in Article 5 (1) and the conditions for entry into service which the Member States lay down on the basis of local climatic conditions and the energy and occupancy characteristics of the buildings. 3. However, Member States where back-boilers and/or boilers that are to be installed in the living space, are widely installed at the date of the adoption of the present Directive, shall continue to authorize their entry into service, provided that their efficiency both at rated output and at 30 % part load is not more than 4 % below the requirements laid down in Article 5 (1) for standard boilers. 4. The effects of the provisions in paragraphs 2 and 3 shall be constantly monitored by the Commission and analysed in the report to be submitted under Article 10. To this end the Member States shall forward to the Commission any information it requires to submit to the Council the proposed amendments, provided for in that Article, designed to ensure at all events the energy efficiency and free movement of boilers in the Community. Article 5 1. Boilers must comply with the following useful efficiency requirements: - at rated output, i.e. operating at rated output Pn expressed in kW, at an average boiler-water temperature of 70 oC, and - a part load, i.e. operating at 30 % part load, at an average boiler-water temperature which varies according to the type of the boiler. The useful efficiency requirements to be complied with are set out in the following table: Type of boiler Range of power output Efficiency at rated output Efficiency at partload kW Average boiler-water temperature (in oC) Efficiency requirement expressed (in %) Average boiler-water temperature (in oC) Efficiency requirement expressed (in %) Standard boilers 4 to 400 70 & {Ì8}; 84 + 2 logPn & {Ì8}; 50 & {Ì8}; 80 + 3 logPn Lowtemperature boilers (*) 4 to 400 70 & {Ì8}; 87,5 + 1,5 logPn 40 & {Ì8}; 87,5 + 1,5 logPn Gas condensing boilers 4 to 400 70 & {Ì8}; 91 + 1 logPn 30 (**) & {Ì8}; 97 + 1 logPn (*) Including condensing boilers using liquid fuels. (**) Temperature of boiler water-supply. 2. The harmonized standards relating to the requirements of this Directive drawn up under mandate from the Commission in accordance with Directive 83/189/EEC and 88/182/EEC (14) shall determine, inter alia, the verification methods valid for production and measurements. Appropriate tolerances must be incorporated in the efficiency levels. Article 6 1. Under the procedures laid down in Article 7, Member States may decide to apply a specific system of labels enabling the energy performance of boilers to be clearly ascertained. This system shall apply to boilers the efficiency of which is superior to the requirements for standard boilers set out in Article 5 (1). If its efficiency at rated output and its efficiency at part load are equal to or greater than the relevant values for standard boilers, a boiler shall be awarded an '& {ÌK};' as set out in Annex I, section 2. If its efficiency at rated output and its efficiency at part load are three or more points higher than the relevant values for standard boilers a boiler shall be awarded '& {ÌK};& {ÌK};'. Every extra step of efficiency of three points at rated output and at part load will allow the attribution of an extra '& {ÌK};' as set out in Annex II. 2. Member States may not authorize any other label likely to be confused with those referred to in paragraph 1. Article 7 1. Member States shall deem that boilers which comply with the harmonized standards, the reference numbers of which have been published in the Official Journal of the European Communities and for which the Member States have published the reference numbers of the national standards transposing those harmonized standards, to be in conformity with the essential efficiency requirements stipulated in Article 5 (1). Such boilers must bear the CE mark referred to in Annex 1, section 1, and be accompanied by the EC declaration of conformity. 2. The conformity of series-produced boilers shall be certified by: - examination of the efficiency of a boiler type in accordance with module B as described in Annex III, - a declaration of conformity to the approved type in accordance with module C, D or E as described in Annex IV. For boilers burning gaseous fuels, the procedures for assessing the conformity of their efficiency shall be those used to assess conformity to the safety requirements laid down in Directive 90/396/EEC on the approximation of the laws of the Member States relating to appliances burning gaseous fuels. 3. When appliances marketed separately are placed on the market, they must bear the CE mark and be accompanied by the EC declaration of conformity, which defines the parameters enabling them after assembly to achieve the useful efficiency levels laid down in Article 5 (1). 4. The CE mark of conformity to the requirements of this Directive and to the other provisions concerning the granting of the CE mark, and also the inscriptions specified in Annex I, shall be affixed on boilers in a visible, easily legible and indelible manner. The affixing on such products of any other mark, sign or indication liable to create confusion with the CE mark both as regards its significance or in its appearance shall be prohibited. Article 8 1. Each Member State shall notify the Commission and the other Member States of the bodies it has appointed to carry out the tasks relating to the procedures referred to in Article 7, hereinafter called 'notified bodies'. The Commission shall allocate identification numbers to those bodies and shall inform the Member States thereof. Lists of the notified bodies shall be published by the Council in the Official Journal of the European Communities and shall be continually updated. 2. Member States shall implement the minimum criteria laid down in Annex V for the appointment of such bodies. Bodies which satisfy the criteria laid down in the corresponding harmonized standards shall be deemed to comply with the criteria laid down in that Annex. 3. A Member State which has notified a particular body must withdraw that notification if it finds that the body concerned no longer satisfies the criteria referred to in paragraph 2. It shall immediately inform the other Member States and the Commission accordingly and shall withdraw the notification. Article 9 1. By 1 January 1993, Member States shall adopt and publish the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions form 1 January 1994. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Until 31 December 1997, Member States shall permit the placing on the market and putting into service of appliances complying with the national rules and schemes in force within their territories on the date of the adoption of this Directive. Article 10 Three years after the implementation of this Directive the Commission shall submit a report to the European Parliament and to the Council on the results achieved. That report shall be accompanied by proposals for any changes to be made to this Directive in the light of those results and of advances in technology. Article 11 This Directive is addressed to the Member States.

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Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora Having regard to the Treaty establishing the European Economic Community, and in particular Article 130s 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 the preservation, protection and improvement of the quality of the environment, including the conservation of natural habitats and of wild fauna and flora, are an essential objective of general interest pursued by the Community, as stated in Article 130r of the Treaty; Whereas the European Community policy and action programme on the environment (1987 to 1992)(4) makes provision for measures regarding the conservation of nature and natural resources; Whereas, the main aim of this Directive being to promote the maintenance of biodiversity, taking account of economic, social, cultural and regional requirements, this Directive makes a contribution to the general objective of sustainable development; whereas the maintenance of such biodiversity may in certain cases require the maintenance, or indeed the encouragement, of human activities; Whereas, in the European territory of the Member States, natural habitats are continuing to deteriorate and an increasing number of wild species are seriously threatened; whereas given that the threatened habitats and species form part of the Community's natural heritage and the threats to them are often of a transboundary nature, it is necessary to take measures at Community level in order to conserve them; Whereas, in view of the threats to certain types of natural habitat and certain species, it is necessary to define them as having priority in order to favour the early implementation of measures to conserve them; Whereas, in order to ensure the restoration or maintenance of natural habitats and species of Community interest at a favourable conservation status, it is necessary to designate special areas of conservation in order to create a coherent European ecological network according to a specified timetable; Whereas all the areas designated, including those classified now or in the future as special protection areas pursuant to Council Directive 79/409/EEC of 2 April 1979 on the conservation of wild birds(5), will have to be incorporated into the coherent European ecological network; Whereas it is appropriate, in each area designated, to implement the necessary measures having regard to the conservation objectives pursued; Whereas sites eligible for designation as special areas of conservation are proposed by the Member States but whereas a procedure must nevertheless be laid down to allow the designation in exceptional cases of a site which has not been proposed by a Member State but which the Community considers essential for either the maintenance or the survival of a priority natural habitat type or a priority species; Whereas an appropriate assessment must be made of any plan or programme likely to have a significant effect on the conservation objectives of a site which has been designated or is designated in future; Whereas it is recognized that the adoption of measures intended to promote the conservation of priority natural habitats and priority species of Community interest is a common responsibility of all Member States; whereas this may, however, impose an excessive financial burden on certain Member States given, on the one hand, the uneven distribution of such habitats and species throughout the Community and, on the other hand, the fact that the "polluter pays" principle can have only limited application in the special case of nature conservation; Whereas it is therefore agreed that, in this exceptional case, a contribution by means of Community co-financing should be provided for within the limits of the resources made available under the Community's decisions; Whereas land-use planning and development policies should encourage the management of features of the landscape which are of major importance for wild fauna and flora; Whereas a system should be set up for surveillance of the conservation status of the natural habitats and species covered by this Directive; Whereas a general system of protection is required for certain species of flora and fauna to complement Directive 79/409/EEC; whereas provision should be made for management measures for certain species, if their conservation status so warrants, including the prohibition of certain means of capture or killing, whilst providing for the possibility of derogations on certain conditions; Whereas, with the aim of ensuring that the implementation of this Directive is monitored, the Commission will periodically prepare a composite report based, inter alia, on the information sent to it by the Member States regarding the application of national provisions adopted under this Directive; Whereas the improvement of scientific and technical knowledge is essential for the implementation of this Directive; whereas it is consequently appropriate to encourage the necessary research and scientific work; Whereas technical and scientific progress mean that it must be possible to adapt the Annexes; whereas a procedure should be established whereby the Council can amend the Annexes; Whereas a regulatory committee should be set up to assist the Commission in the implementation of this Directive and in particular when decisions on Community co-financing are taken; Whereas provision should be made for supplementary measures governing the reintroduction of certain native species of fauna and flora and the possible introduction of non-native species; Whereas education and general information relating to the objectives of this Directive are essential for ensuring its effective implementation, Definitions Article 1 For the purpose of this Directive: (a) conservation means a series of measures required to maintain or restore the natural habitats and the populations of species of wild fauna and flora at a favourable status as defined in (e) and (i); (b) natural habitats means terrestrial or aquatic areas distinguished by geographic, abiotic and biotic features, whether entirely natural or semi-natural; (c) natural habitat types of Community interest means those which, within the territory referred to in Article 2: (i) are in danger of disappearance in their natural range; or (ii) have a small natural range following their regression or by reason of their intrinsically restricted area; or (iii) present outstanding examples of typical characteristics of one or more of the five following biogeographical regions: Alpine, Atlantic, Continental, Macaronesian and Mediterranean. Such habitat types are listed or may be listed in Annex I; (d) priority natural habitat types means natural habitat types in danger of disappearence, which are present on the territory referred to in Article 2 and for the conservation of which the Community has particular responsibility in view of the proportion of their natural range which falls within the territory referred to in Article 2; these priority natural habitat types are indicated by an asterisk (*) in Annex I; (e) conservation status of a natural habitat means the sum of the influences acting on a natural habitat and its typical species that may affect its long-term natural distribution, structure and functions as well as the long-term survival of its typical species within the territory referred to in Article 2. The conservative status of a natural habitat will be taken as "favourable" when: - its natural range and areas it covers within that range are stable or increasing, and - the specific structure and functions which are necessary for its long-term maintenance exist and are likely to continue to exist for the foreseeable future, and - the conservation status of its typical species is favourable as defined in (i); (f) habitat of a species means an environment defined by specific abiotic and biotic factors, in which the species lives at any stage of its biological cycle; (g) species of Community interest means species which, within the territory referred to in Article 2, are: (i) endangered, except those species whose natural range is marginal in that territory and which are not endangered or vulnerable in the western palearctic region; or (ii) vulnerable, i.e. believed likely to move into the endangered category in the near future if the causal factors continue operating; or (iii) rare, i.e. with small populations that are not at present endangered or vulnerable, but are at risk. The species are located within restricted geographical areas or are thinly scattered over a more extensive range; or (iv) endemic and requiring particular attention by reason of the specific nature of their habitat and/or the potential impact of their exploitation on their habitat and/or the potential impact of their exploitation on their conservation status. Such species are listed or may be listed in Annex II and/or Annex IV or V; (h) priority species means species referred to in (g) (i) for the conservation of which the Community has particular responsibility in view of the proportion of their natural range which falls within the territory referred to in Article 2; these priority species are indicated by an asterisk (*) in Annex II; (i) conservation status of a species means the sum of the influences acting on the species concerned that may affect the long-term distribution and abundance of its populations within the territory referred to in Article 2; The conservation status will be taken as "favourable" when: - population dynamics data on the species concerned indicate that it is maintaining itself on a long-term basis as a viable component of its natural habitats, and - the natural range of the species is neither being reduced nor is likely to be reduced for the foreseeable future, and - there is, and will probably continue to be, a sufficiently large habitat to maintain its populations on a long-term basis; (j) site means a geographically defined area whose extent is clearly delineated; (k) site of Community importance means a site which, in the biogeographical region or regions to which is belongs, contributes significantly to the maintenance or restoration at a favourable conservation status of a natural habitat type in Annex I or of a species in Annex II and may also contribute significantly to the coherence of Natura 2000 referred to in Article 3, and/or contributes significantly to the maintenance of biological diversity within the biogeographic region or regions concerned. For animal species ranging over wide areas, sites of Community importance shall correspond to the places within the natural range of such species which present the physical or biological factors essential to their life and reproduction; (l) special area of conservation means a site of Community importance designated by the Member States through a statutory, administrative and/or contractual act where the necessary conservation measures are applied for the maintenance or restoration, at a favourable conservation status, of the natural habitats and/or the populations of the species for which the site is designated; (m) specimen means any animal or plant, whether alive or dead, of the species listed in Annex IV and Annex V, any part or derivative thereof, as well as any other goods which appear, from an accompanying document, the packaging or a mark or label, or from any other circumstances, to be parts or derivatives of animals or plants of those species; (n) the committee means the committee set up pursuant to Article 20. Article 2 1. The aim of this Directive shall be to contribute towards ensuring bio-diversity through the conservation of natural habitats and of wild fauna and flora in the European territory of the Member States to which the Treaty applies. 2. Measures taken pursuant to this Directive shall be designed to maintain or restore, at favourable conservation status, natural habitats and species of wild fauna and flora of Community interest. 3. Measures taken pursuant to this Directive shall take account of economic, social and cultural requirements and regional and local characteristics. Conservation of natural habitats and habitats of species Article 3 1. A coherent European ecological network of special areas of conservation shall be set up under the title Natura 2000. This network, composed of sites hosting the natural habitat types listed in Annex I and habitats of the species listed in Annex II, shall enable the natural habitat types and the species' habitats concerned to be maintained or, where appropriate, restored at a favourable conservation status in their natural range. The Natura 2000 network shall include the special protection areas classified by the Member States pursuant to Directive 79/409/EEC. 2. Each Member State shall contribute to the creation of Natura 2000 in proportion to the representation within its territory of the natural habitat types and the habitats of species referred to in paragraph 1. To that effect each Member State shall designate, in accordance with Article 4, sites as special areas of conservation taking account of the objectives set out in paragraph 1. 3. Where they consider it necessary, Member States shall endeavour to improve the ecological coherence of Natura 2000 by maintaining, and where appropriate developing, features of the landscape which are of major importance for wild fauna and flora, as referred to in Article 10. Article 4 1. On the basis of the criteria set out in Annex III (Stage 1) and relevant scientific information, each Member State shall propose a list of sites indicating which natural habitat types in Annex I and which species in Annex II that are native to its territory the sites host. For animal species ranging over wide areas these sites shall correspond to the places within the natural range of such species which present the physical or biological factors essential to their life and reproduction. For aquatic species which range over wide areas, such sites will be proposed only where there is a clearly identifiable area representing the physical and biological factors essential to their life and reproduction. Where appropriate, Member States shall propose adaptation of the list in the light of the results of the surveillance referred to in Article 11. The list shall be transmitted to the Commission, within three years of the notification of this Directive, together with information on each site. That information shall include a map of the site, its name, location, extent and the data resulting from application of the criteria specified in Annex III (Stage 1) provided in a format established by the Commission in accordance with the procedure laid down in Article 21. 2. On the basis of the criteria set out in Annex III (Stage 2) and in the framework both of each of the five biogeographical regions referred to in Article 1 (c) (iii) and of the whole of the territory referred to in Article 2 (1), the Commission shall establish, in agreement with each Member State, a draft list of sites of Community importance drawn from the Member States' lists identifying those which lost one or more priority natural habitat types or priority species. Member States whose sites hosting one or more priority natural habitat types and priority species represent more than 5 % of their national territory may, in agreement with the Commission, request that the criteria listed in Annex III (Stage 2) be applied more flexibly in selecting all the sites of Community importance in their territory. The list of sites selected as sites of Community importance, identifying those which host one or more priority natural habitat types or priority species, shall be adopted by the Commission in accordance with the procedure laid down in Article 21. 3. The list referred to in paragraph 2 shall be established within six years of the notification of this Directive. 4. Once a site of Community importance has been adopted in accordance with the procedure laid down in paragraph 2, the Member State concerned shall designate that site as a special area of conservation as soon as possible and within six years at most, establishing priorities in the light of the importance of the sites for the maintenance or restoration, at a favourable conservation status, of a natural habitat type in Annex I or a species in Annex II and for the coherence of Natura 2000, and in the light of the threats of degradation or destruction to which those sites are exposed. 5. As soon as a site is placed on the list referred to in the third subparagraph of paragraph 2 it shall be subject to Article 6 (2), (3) and (4). Article 5 1. In exceptional cases where the Commission finds that a national list as referred to in Article 4 (1) fails to mention a site hosting a priority natural habitat type or priority species which, on the basis of relevant and reliable scientific information, it considers to be essential for the maintenance of that priority natural habitat type or for the survival of that priority species, a bilateral consultation procedure shall be initiated between that Member State and the Commission for the purpose of comparing the scientific data used by each. 2. If, on expiry of a consultation period not exceeding six months, the dispute remains unresolved, the Commission shall forward to the Council a proposal relating to the selection of the site as a site of Community importance. 3. The Council, acting unanimously, shall take a decision within three months of the date of referral. 4. During the consultation period and pending a Council decision, the site concerned shall be subject to Article 6 (2). Article 6 1. For special areas of conservation, Member States shall establish the necessary conservation measures involving, if need be, appropriate management plans specifically designed for the sites or integrated into other development plans, and appropriate statutory, administrative or contractual measures which correspond to the ecological requirements of the natural habitat types in Annex I and the species in Annex II present on the sites. 2. Member States shall take appropriate steps to avoid, in the special areas of conservation, the deterioration of natural habitats and the habitats of species as well as disturbance of the species for which the areas have been designated, in so far as such disturbance could be significant in relation to the objectives of this Directive. 3. Any plan or project not directly connected with or necessary to the management of the site but likely to have a significant effect thereon, either individually or in combination with other plans or projects, shall be subject to appropriate assessment of its implications for the site in view of the site's conservation objectives. In the light of the conclusions of the assessment of the implications for the site and subject to the provisions of paragraph 4, the competent national authorities shall agree to the plan or project only after having ascertained that it will not adversely affect the integrity of the site concerned and, if appropriate, after having obtained the opinion of the general public. 4. If, in spite of a negative assessment of the implications for the site and in the absence of alternative solutions, a plan or project must nevertheless be carried out for imperative reasons of overriding public interest, including those of a social or economic nature, the Member State shall take all compensatory measures necessary to ensure that the overall coherence of Natura 2000 is protected. It shall inform the Commission of the compensatory measures adopted. Where the site concerned hosts a priority natural habitat type and/or a priority species, the only considerations which may be raised are those relating to human health or public safety, to beneficial consequences of primary importance for the environment or, further to an opinion from the Commission, to other imperative reasons of overriding public interest. Article 7 Obligations arising under Article 6 (2), (3) and (4) of this Directive shall replace any obligations arising under the first sentence of Article 4 (4) of Directive 79/409/EEC in respect of areas classified pursuant to Article 4 (1) or similarly recognized under Article 4 (2) thereof, as from the date of implementation of this Directive or the date of classification or recognition by a Member State under Directive 79/409/EEC, where the latter date is later. Article 8 1. In parallel with their proposals for sites eligible for designation as special areas of conservation, hosting priority natural habitat types and/or priority species, the Member States shall send, as appropriate, to the Commission their estimates relating to the Community co-financing which they consider necessary to allow them to meet their obligations pursuant to Article 6 (1). 2. In agreement with each of the Member States concerned, the Commission shall identify, for sites of Community importance for which co-financing is sought, those measures essential for the maintenance or re-establishment at a favourable conservation status of the priority natural habitat types and priority species on the sites concerned, as well as the total costs arising from those measures. 3. The Commission, in agreement with the Member States concerned, shall assess the financing, including co-financing, required for the operation of the measures referred to in paragraph 2, taking into account, amongst other things, the concentration on the Member State's territory of priority natural habitat types and/or priority species and the relative burdens which the required measures entail. 4. According to the assessment referred to in paragraphs 2 and 3, the Commission shall adopt, having regard to the available sources of funding under the relevant Community instruments and according to the procedure set out in Article 21, a prioritized action framework of measures involving co-financing to be taken when the site has been designated under Article 4 (4). 5. The measures which have not been retained in the action framework for lack of sufficient resources, as well as those included in the abovementioned action framework which have not received the necessary co-financing or have only been partially co-financed, shall be reconsidered in accordance with the procedure set out in Article 21, in the context of the two-yearly review of the action framework and may, in the maintime, be postponed by the Member States pending such review. This review shall take into account, as appropriate, the new situation of the site concerned. 6. In areas where the measures dependent on co-financing are postponed, Member States shall refrain from any new measures likely to result in deterioration of those areas. Article 9 The Commission, acting in accordance with the procedure laid down in Article 21, shall periodically review the contribution of Natura 2000 towards achievement of the objectives set out in Article 2 and 3. In this context, a special area of conservation may be considered for declassification where this is warranted by natural developments noted as a result of the surveillance provided for in Article 11. Article 10 Member States shall endeavour, where they consider it necessary, in their land-use planning and development policies and, in particular, with a view to improving the ecological coherence af the Natura 2000 network, to encourage the management of features of the landscape which are of major importance for wild fauna and flora. Such features are those which, by virtue of their linear and continuous structure (such as rivers with their banks or the traditional systems for marking field boundaries) or their function as stepping stones (such as ponds or small woods), are essential for the migration, dispersal and genetic exchange of wild species. Article 11 Member States shall undertake surveillance of the conservation status of the natural habitats and species referred to in Article 2 with particular regard to priority natural habitat types and priority species. Protection of species Article 12 1. Member States shall take the requisite measures to establish a system of strict protection for the animal species listed in Annex IV (a) in their natural range, prohibiting: (a) all forms of deliberate capture or killing of specimens of these species in the wild; (b) deliberate disturbance of these species, particularly during the period of breeding, rearing, hibernation and migration; (c) deliberate destruction or taking of eggs from the wild; (d) deterioration or destruction of breeding sites or resting places. 2. For these species, Member States shall prohibit the keeping, transport and sale or exchange, and offering for sale or exchange, of specimens taken from the wild, except for those taken legally before this Directive is implemented. 3. The prohibition referred to in paragraph 1 (a) and (b) and paragraph 2 shall apply to all stages of life of the animals to which this Article applies. 4. Member States shall establish a system to monitor the incidential capture and killing of the animal species listed in Annex IV (a). In the light of the information gathered, Member States shall take further research or conservation measures as required to ensure that incidental capture and killing does not have a significant negative impact on the species concerned. Article 13 1. Member States shall take the requisite measures to establish a system of strict protection for the plant species listed in Annex IV (b), prohibiting: (a) the deliberate picking, collecting, cutting, uprooting or destruction of such plants in their natural range in the wild; (b) the keeping, transport and sale or exchange and offering for sale or exchange of specimens of such species taken in the wild, except for those taken legally before this Directive is implemented. 2. The prohibitions referred to in paragraph 1 (a) and (b) shall apply to all stages of the biological cycle of the plants to which this Article applies. Article 14 1. If, in the light of the surveillance provided for in Article 11, Member States deem it necessary, they shall take measures to ensure that the taking in the wild of specimens of species of wild fauna and flora listed in Annex V as well as their exploitation is compatible with their being maintained at a favourable conservation status. 2. Where such measures are deemed necessary, they shall include continuation of the surveillance provided for in Article 11. Such measures may also include in particular: - regulations regarding access to certain property, - temporary or local prohibition of the taking of specimens in the wild and exploitation of certain populations, - regulation of the periods and/or methods of taking specimens, - application, when specimens are taken, of hunting and fishing rules which take account of the conservation of such populations, - establishment of a system of licences for taking specimens or of quotas, - regulation of the purchase, sale, offering for sale, keeping for sale or transport for sale of specimens, - breeding in captivity of animal species as well as artificial propagation of plant species, under strictly controlled conditions, with a view to reducing the taking of specimens of the wild, - assessment of the effect of the measures adopted. Article 15 In respect of the capture or killing of species of wild fauna listed in Annex V (a) and in cases where, in accordance with Article 16, derogations are applied to the taking, capture or killing of species listed in Annex IV (a), Member States shall prohibit the use of all indiscriminate means capable of causing local disappearance of, or serious disturbance to, populations of such species, and in particular: (a) use of the means of capture and killing listed in Annex VI (a); (b) any form of capture and killing from the modes of transport referred to in Annex VI (b). Article 16 1. Provided that there is no satisfactory alternative and the derogation is not detrimental to the maintenance of the populations of the species concerned at a favourable conservation status in their natural range, Member States may derogate from the provisions of Articles 12, 13, 14 and 15 (a) and (b): (a) in the interest of protecting wild fauna and flora and conserving natural habitats; (b) to prevent serious damage, in particular to crops, livestock, forests, fisheries and water and other types of property; (c) in the interests of public health and public safety, or for other imperative reasons of overriding public interest, including those of a social or economic nature and beneficial consequences of primary importance for the environment; (d) for the purpose of research and education, of repopulating and re-introducing these species and for the breedings operations necessary for these purposes, including the artificial propagation of plants; (e) to allow, under strictly supervised conditions, on a selective basis and to a limited extent, the taking or keeping of certain specimens of the species listed in Annex IV in limited numbers specified by the competent national authorities. 2. Member States shall forward to the Commission every two years a report in accordance with the format established by the Committee on the derogations applied under paragraph 1. The Commission shall give its opinion on these derogations within a maximum time limit of 12 months following receipt of the report and shall give an account to the Committee. 3. The reports shall specify: (a) the species which are subject to the derogations and the reason for the derogation, including the nature of the risk, with, if appropriate, a reference to alternatives rejected and scientific data used; (b) the means, devices or methods authorized for the capture or killing of animal species and the reasons for their use; (c) the circumstances of when and where such derogations are granted; (d) the authority empowered to declare and check that the required conditions obtain and to decide what means, devices or methods may be used, within what limits and by what agencies, and which persons are to carry but the task; (e) the supervisory measures used and the results obtained. Information Article 17 1. Every six years from the date of expiry of the period laid down in Article 23, Member States shall draw up a report on the implementation of the measures taken under this Directive. This report shall include in particular information concerning the conservation measures referred to in Article 6 (1) as well as evaluation of the impact of those measures on the conservation status of the natural habitat types of Annex I and the species in Annex II and the main results of the surveillance referred to in Article 11. The report, in accordance with the format established by the committee, shall be forwarded to the Commission and made accessible to the public. 2. The Commission shall prepare a composite report based on the reports referred to in paragraph 1. This report shall include an appropriate evaluation of the progress achieved and, in particular, of the contribution of Natura 2000 to the achievement of the objectives set out in Article 3. A draft of the part of the report covering the information supplied by a Member State shall be forwarded to the Member State in question for verification. After submission to the committee, the final version of the report shall be published by the Commission, not later than two years after receipt of the reports referred to in paragraph 1, and shall be forwarded to the Member States, the European Parliament, the Council and the Economic and Social Committee. 3. Member States may mark areas designated under this Directive by means of Community notices designed for that purpose by the committee. Research Article 18 1. Member States and the Commission shall encourage the necessary research and scientific work having regard to the objectives set out in Article 2 and the obligation referred to in Article 11. They shall exchange information for the purposes of proper coordination of research carried out at Member State and at Community level. 2. Particular attention shall be paid to scientific work necessary for the implementation of Articles 4 and 10, and transboundary cooperative research between Member States shall be encouraged. Procedure for amending the Annexes Article 19 Such amendments as are necessary for adapting Annexes I, II, III, V and VI to technical and scientific progress shall be adopted by the Council acting by qualified majority on a proposal from the Commission. Such amendments as are necessary for adapting Annex IV to technical and scientific progress shall be adopted by the Council acting unanimously on a proposal from the Commission. Committee Article 20 The Commission shall be assisted by a committee consisting of representatives of the Member States and chaired by a representative of the Commission. Article 21 1. The representative of the Commission 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. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The Chairman shall not vote. 2. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. If 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 relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. Supplementary provisions Article 22 In implementing the provisions of this Directive, Member States shall: (a) study the desirability of re-introducing species in Annex IV that are native to their territory where this might contribute to their conservation, provided that an investigation, also taking into account experience in other Member States or elsewhere, has established that such re-introduction contributes effectively to re-establishing these species at a favourable conservation status and that it takes place only after proper consultation of the public concerned; (b) ensure that the deliberate introduction into the wild of any species which is not native to their territory is regulated so as not to prejudice natural habitats within their natural range or the wild native fauna and flora and, if they consider it necessary, prohibit such introduction. The results of the assessment undertaken shall be forwarded to the committee for information; (c) promote education and general information on the need to protect species of wild fauna and flora and to conserve their habitats and natural habitats. Final provisions Article 23 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within two years of its notification. They shall forthwith inform the Commission thereof. 2. When Member States adopt such measures, they shall contain a reference to this Directive or 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. 3. Member States shall communicate to the Commission the main provisions of national law which they adopt in the field covered by this Directive. Article 24 This Directive is addressed to the Member States.

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Council Directive 92/44/EEC of 5 June 1992 on the application of open network provision to leased lines 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), (1) Whereas Council Directive 90/387/EEC of 28 June 1990 on the establishment of the internal market for telecommunications services through the implementation of open network provision (4), provides that the Council shall adopt specific open network provision conditions for leased lines; (2) Whereas in this Directive the concept of leased lines covers the offer of transparent transmission capacity between network termination points as a separate service and does not include on-demand switching or offers which form part of a switched service offered to the public; (3) Whereas, in accordance with Commission Directive 90/388/EEC of 28 June 1990 on competition in the markets for telecommunications services (5), Member States which maintain special or exclusive rights for the provision and operation of public telecommunications networks shall take the necessary measures to make the conditions governing access to and use of the network objective and non-discriminatory and publish them; whereas it is necessary to harmonize which specifications should be published and under which form, in order to facilitate the provision of competitive services using leased lines, within Member States and between Member States, and in particular the provision of services by companies, firms or natural persons established in a Member State other than that of the company, firm or natural person for whom the services are intended; (4) Whereas, in application of the principle of non-discrimination, leased lines shall be offered and provided on request without discrimination to all users; (5) Whereas the principle of non-discrimination as laid down in the Treaty applies to, inter alia, availability of technical access, tariffs, quality of service, provision time (delivery period), fair distribution of capacity in case of scarcity, repair time, availability of network information and customer proprietary information, subject to relevant regulatory provisions on data protection; (6) Whereas a number of technical restrictions have been applied, in particular for the interconnection of leased lines among each other or for the interconnection of leased lines and public telecommunications networks; whereas such restrictions, which impede the use of leased lines for the provision of competitive services, are not justified, as they can be replaced by less restrictive regulatory measures; (7) Whereas, in accordance with Community law, access to and use of leased lines may only be restricted in application of essential requirements as defined in this Directive and to safeguard exclusive or special rights; whereas those restrictions must be objectively justified, must follow the principle of proportionality and must not be excessive in relation to the aim pursued; whereas it is necessary to specify the application of these essential requirements in respect of leased lines; (8) Whereas, in accordance with Directive 90/388/EEC which does not apply to telex, mobile radiotelephony, paging and satellite services, Member States shall withdraw all special or exclusive rights for the supply of telecommunications services other than voice telephony; whereas this is the commercial provision for the public of the direct transport and switching of speech in real-time between public switched network termination points, enabling any user to use equipment connected to such a network termination point in order to communicate with another termination point; (9) Whereas Member States may, until the dates provided in Directive 90/388/EEC prohibit, as regards packet- or circuit-switched data services, economic operators from offering leased line capacity for simple resale to the public; whereas there should be no other restriction on the use of leased lines, in particular in respect of the transmission of signals which are not originated by the user who subscribed to the leased line offering, the transmission of signals which are not finally destined for the user who subscribed to the leased line offering, or the transmission of signals which are neither originated by nor finally destined for the user who subscribed to the leased line offering; (10) Whereas, in accordance with Directive 90/387/EEC, the Community-wide definition of harmonized technical interfaces and access conditions must be based on the definition of common technical specifications based on international standards and specifications; (11) Whereas, in accordance with Directive 90/388/EEC, Member States which maintain special or exclusive rights for the provision and operation of public telecommunications networks shall ensure that those who so request can obtain leased lines within a reasonable period; (12) Whereas, in order to make leased lines available to a sufficient extent to users for their own use, for shared use or for the provision of services to third parties, it is necessary that Member States ensure that a harmonized set of leased lines with defined network termination points is made available in all Member States both for communications within a Member State and between Member States; whereas it is therefore necessary to determine which type of leased lines should be included in the harmonized set and within which time limit if they are not yet available; whereas given the dynamic technological development in this sector, it is necessary to establish a procedure for adjusting or enlarging such a set; (13) Whereas other leased lines, in addition to the harmonized minimum set, will also be provided subject to market demand and the state of public telecommunications network; whereas the other provisions of this Directive apply to these leased lines; whereas however it should be ensured that the provision of these other leased lines does not impede the provision of the minimum set of leased lines; (14) Whereas in conformity with the principle of separation of regulatory and operational functions and in application of the principle of subsidiarity, the national regulatory authority of each Member State will play an important role for the implementation of this Directive; (15) Whereas common ordering procedures, as well as one-stop ordering and one-stop billing are needed in order to encourage the use of leased lines throughout the Community; whereas any cooperation of the telecommunications organizations in that respect is subject to compliance with Community competition law; whereas, in particular, such procedures should respect the principle of cost orientation and should not result in any price fixing or market sharing; (16) Whereas the implementation of one-stop ordering and one-stop billing procedures by telecommunications organizations must not prevent offers by service providers other than telecommunications organizations; (17) Whereas, in accordance with Directive 90/387/EEC, tariffs for leased lines must be based on the following principles; they must be based on objective criteria and must follow the principle of cost-orientation, taking into account a reasonable time needed for rebalancing; they must be transparent and properly published; they must be sufficiently unbundled in accordance with the competition rules of the Treaty and they must be non-discriminatory and guarantee equality of treatment; whereas tariffs for leased lines provided by one or more telecommunications organization must be based on the same principles; whereas a favourable prejudice is given to a tariff based on a flat-rate periodic rental, except where other types of tariffs are justified by cost; (18) Whereas any charge for access to and use of leased lines must comply with the principles set out above and with the competition rules of the Treaty and must also take into account the principle of fair sharing in the global cost of the resources used and the need for a reasonable level of return on investment which is required for the further development of the telecommunications infrastructure; (19) Whereas, in order to ensure the application of the tariff principles set out in the previous two recitals, telecommunications organizations shall use an appropriate transparent cost accounting system which can be verified by accounting experts ensuring the production of recorded figures; whereas such requirement can be fulfilled for example by the implementation of the principle of fully distributed costing; (20) Whereas to enable the Commission to monitor effectively the application of this Directive, it is necessary that Member States notify to the Commission which national regulatory authority will be responsible for its implementation and provide the relevant information requested by the Commission; (21) Whereas the Committee referred to in Articles 9 and 10 of Directive 90/387/EEC should play an important role for the application of this Directive; (22) Whereas disagreements between users and telecommunications organizations on the provision of leased lines will normally be solved between these parties involved; whereas it must be possible for parties to refer their case to a national regulatory authority and the Commission in cases where this is considered necessary; whereas this does not prejudice normal application of the procedures laid down in Articles 169 and 170 and the competition rules of the Treaty; (23) Whereas a specific procedure must be established in order to examine whether, in justified cases, the time limit set out in this Directive for the provision of a minimum set of leased lines and for the implementation of an appropriate cost accounting system may be extended; (24) Whereas this Directive does not apply to leased lines one network termination point of which is located outside the Community, Article 1 Scope This Directive concerns the harmonization of conditions for open and efficient access to and use of the leased lines provided to users on public telecommunications networks, and the availability throughout the Community of a minimum set of leased lines with harmonized technical characteristics. Article 2 Definitions 1. The definitions given in Directive 90/387/EEC shall apply, where relevant, to this Directive. 2. In addition, for the purposes of this Directive, - leased lines means the telecommunications facilities provided in the context of the establishment, development and operation of the public telecommunications network, which provide for transparent transmission capacity between network termination points and which do not include on-demand switching (switching functions with the user can control as part of the leased line provision), - ONP Committee means the Committee referred to in Articles 9 and 10 of Directive 90/387/EEC, - users means end users and service providers, including telecommunications organizations where the latter are engaged in providing services which are or may be provided also by others, - national regulatory authority means the body or bodies in each Member State, legally distinct and functionally independent of the telecommunications organizations, entrusted by that Member State inter alia with the regulatory functions addressed in this Directive, - simple resale of capacity means the commercial provision on leased lines for the public of data transmission as a separate service, including only such switching, processing, data storage or protocol conversion as is necessary for transmission in real time to and from the public switched network, - common ordering procedure means an ordering procedure for the procurement of intra-Community leased lines which ensures that there is commonality across the telecommunications organizations in the information that has to be suplied by the user and the telecommunications organizations, and in the format in which the information is presented, - one-stop-ordering is a system whereby all transactions involving a user, required for the procurement of intra-Community leased lines, supplied by more than one telecommunications organization to a single user, can be completed at one location between the user and a single telecommunications organization, - one-stop-billing is a system whereby the billing and payment transaction for intra-Community leased lines supplied by more than one telecommunications organization to a single user can be completed at one location between the user and a single telecommunications organization. Article 3 Availability of information 1. Member States shall ensure that information in respect of leased lines, offerings on technical characteristics, tariffs, supply and usage conditions, licensing and declaration requirements, and the conditions for the attachment of terminal equipment is published in accordance with the presentation given in Annex I. Changes in existing offerings shall be published as soon as possible and, unless the national regulatory authority agrees otherwise, no later than two months before the implementation. 2. The information referred to in paragraph 1 shall be published in an appropriate manner so as to provide easy access for users to that information. Reference shall be made in the national Official Journal of the Member State concerned to the publication of this information. Member States shall notify to the Commission before 1 January 1993, and thereafter in case of any change, the manner in which the information is made available. The Commission will regularly publish reference to such notifications. 3. Member States shall ensure that information concerning new types of leased line offerings will be published as soon as possible, and no later than two months before the implementation of the offering. Article 4 Information on supply conditions The supply conditions to be published pursuant to Article 3 shall include at least: - information concerning the ordering procedure - the typical delivery period, which is the period, counted from the date when the user has made a firm request for a leased line, in which 80 % of all leased lines of the same type have been put through to the customers. This period will be established on the basis of the actual delivery periods of leased lines during a recent time interval of reasonable duration. The calculation must not include cases where late delivery periods were requested by users. For new types of leased lines a target delivery period shall be published instead of the typical delivery period, - the contractual period, which includes the period which is in general foreseen for the contract and the minimum contractual period which the user is obliged to accept, - the typical repair time, which is the period, counted from the time when a failure message has been given to the responsible unit within the telecommunications organization up to the moment in which 80 % of all leased lines of the same type have been re-established and in appropriate cases notified back in operation to the users. For new types of leased lines a target repair time period shall be published instead of the typical repair time. Where different classes of quality of repair are offered for the same type of leased lines, the different typical repair times shall be published, - any refund procedure. Article 5 Conditions for the termination of offerings Member States shall ensure that existing offerings continue for a reasonable period of time, and that termination of an offering can be done only after consultation with users affected. Without prejudice to other rights of appeal provided for by national laws, Member States shall ensure that users can bring the case before the national regulatory authority where the users do not agree with the termination date as envisaged by the telecommunications organization. Article 6 Access conditions, usage conditions and essential requirements 1. Without prejudice to Articles 2 and 3 of Directive 90/388/EEC, Member States shall ensure that when access to and usage of leased lines is restricted, these restrictions are aimed only at ensuring compliance with the essential requirements, compatible with Community law, and are imposed by the national regulatory authorities through regulatory means. No technical restrictions shall be introduced or maintained for the intercommunication of leased lines and public telecommunications networks. 2. Where access to and use of leased lines are restricted on the basis of essential requirements, Member States shall ensure that the relevant national provisions identify which of the essential requirements listed in paragraph 3 are the basis of such restrictions. 3. The essential requirements specified in Article 3 (2) of Directive 90/387/EEC shall apply to leased lines in the following manner: (a) Security of network operations A telecommunication organization may take the following measures in order to safeguard the security of network operations during the period when an emergency situation prevails: - the interruption of the service, - the limitation of service features, - the denial of access to the service. An emergency situation in this context means an exceptional case of force majeure, such as extreme weather, flood, lightning or fire, industrial action or lockouts, war, military operations, or civil disorder. In an emergency situation the telecommunications organization shall make every endeavour to ensure that service is maintained to all users. The Member States shall ensure that the telecommunications organization immediately notifies to the users and to the national regulatory authority the beginning and the end of the emergency as well as the nature and extent of temporary service restrictions; (b) Maintenance of network integrity The user has the right to be provided with a fully transparent service, in conformity with the specifications of the network termination point, which he can use in an unstructured manner as he wants, e.g. where no channel allocations are forbidden or prescribed. There shall be no restrictions on the use of leased lines on the ground of the maintenance of network integrity, as long as the access conditions related to terminal equipment are fulfilled; (c) Interoperability of services Without prejudice to the application of Article 3 (5) and Article 5 (3) of Directive 90/387/EEC, the use of a leased line shall not be restricted on the grounds of the interoperability of services, when the access conditions related to terminal equipment are fulfilled; (d) Protection of data In respect of data protection, Member States may restrict the use of leased lines only to the extent necessary to ensure compliance with relevant regulatory provisions on the protection of data including protection of personal data, the confidentiality of information transmitted or stored, as well as the protection of privacy compatible with Community law. 4. Access conditions related to terminal equipment Access conditions related to terminal equipment are considered to be fulfilled when the terminal equipment complies with the approval conditions set out for its connection to the network termination point of the type of leased line concerned, in accordance with Directive 91/263/EEC (6). In the case where a user's terminal equipment does not comply or no longer complies with these conditions, the provision of the leased line may be interrupted until the terminal is disconnected from the network termination point. Member States shall ensure that the telecommunications organization immediately informs the user about the interruption, giving the reasons for the interruption. As soon as the user has ensured that the non-complying terminal equipment is disconnected from the network termination point, the provision of the leased line shall be restored. Article 7 Provision of a minimum set of leased lines in accordance with harmonized technical characteristics 1. Member States shall ensure that the respective telecommunications organizations separately or jointly provide a minimum set of leased lines in accordance with Annex II, in order to guarantee a harmonized offering throughout the Community. 2. Where leased lines which implement the standards listed in Annex II are not yet available, Member States shall take the necessary measures to ensure that these types of leased lines will be implemented by the date resulting from the application of Article 15. 3. The modifications necessary to adapt Annex II to new technical developments and to changes in market demand, including the possible deletion of certain types of leased lines from the Annex, shall be adopted by the Commission under the procedure provided for in Article 10 of Directive 90/387/EEC, taking into account the state of development of national networks. 4. The provision of other leased lines beyond the minimum set of leased lines which must be provided by Member States shall not impede the provision of this minimum set of leased lines. Article 8 Control by the national regulatory authority 1. Member States shall ensure that the national regulatory authority lays down the procedures whereby it decides, on a case-by-case basis and in the shortest time period, to allow or not telecommunications organizations to take measures such as the refusal to provide a leased line, the interruption of the provision of leased lines or the reduction of the availability of leased line features for reasons of alleged failure to comply with the usage conditions by users of leased lines. These procedures may also foresee the possibility for the national regulatory authority to authorize, a priori, specified measures in the case of defined infringements of usage conditions. Member States shall ensure that these procedures provide for a transparent decision-making process in which due respect is given to the rights of the parties. The decision shall be taken after having given the opportunity to both parties to state their case. The decision shall be motivated and notified to the parties within one week of its adoption: it shall not be enforced before its notification. This provision shall not prejudice the right of the parties concerned to apply to the courts. 2. The national regulatory authority shall ensure that telecommunications organizations adhere to the principle of non-discrimination when they make use of the public telecommunications network for providing services which are or may be provided also by other service providers. When telecommunications organizations use leased lines for the provision of services not covered by special and/or exclusive rights, the same type of leased lines must be provided to other users on request and under equal conditions. 3. Where, in response to a particular request, a telecommunications organization considers it unreasonable to provide a leased line under its published tariffs and supply conditions, it must seek the agreement of the national regulatory authority to vary those conditions in that case. Article 9 Common ordering and billing procedures 1. Member States shall encourage the establishment, by 31 December 1992 at the latest, in conformity with the procedural and substantive rules of competition of the Treaty and in consultation with users, of: - a common ordering procedure for leased lines throughout the Community, - a one-stop-ordering procedure for leased lines, to be applied where requested by the user, - a one-stop-billing procedure for leased lines, to be applied where requested by the user. The procedure shall foresee that all price elements resulting from the national leased lines and the respective parts of international leased lines provided by the telecommunications organizations involved are identified separately in the bill for the user. 2. Member States shall report to the Commission one year after this Directive is brought into effect on the results achieved with respect to the procedures provided for in paragraph 1. These results shall be examined by the ONP Committee. Article 10 Tariffing principles and cost accounting 1. Member States shall ensure that tariffs for leased lines follow the basic principles of cost orientation and transparency in accordance with the following rules: (a) tariffs for leased lines shall be independent of the type of application which the users of the leased lines implement; (b) tariffs for leased lines shall normally contain the following elements: - an initial connection charge, - a periodic rental charge, i.e. a flat-rate element. When other tariff elements are applied, these must be transparent and based on objective criteria; (c) tariffs for leased lines apply to the facilities provided between network termination points at which the user has access to the leased lines. For leased lines provided by more than one telecommunications organization, half-circuit tariffs, i.e. from one network termination point to a hypothetical mid-circuit point, can be applied. 2. Member States shall ensure that their telecommunications organizations formulate and put in practice, by 31 December 1993 at the latest, a cost accounting system suitable for the implementation of paragraph 1. Without prejudice to the last subparagraph, the system referred to in the first subparagraph shall include the following elements: (a) the costs of leased lines shall in particular include the direct costs incurred by the telecommunications organizations for setting up, operating and maintaining leased lines, and for marketing and billing of leased lines; (b) common costs, that is costs which can neither be directly assigned to leased lines nor to other activities, are allocated as follows: (i) whenever possible, common cost categories shall be allocated based upon direct analysis of the origin of the costs themselves; (ii) when direct analysis is not possible, common cost categories shall be allocated based upon an indirect linkage to another cost category or group of cost categories for which a direct assignment or allocation is possible. The indirect linkage shall be based on comparable cost structures; (iii) when neither direct nor indirect measures of cost allocation can be found, the cost category shall be allocated based upon a general allocator computed by using the ratio of all expenses directly assigned or allocated to, on the one hand, services which are provided under special or exclusive rights and, on the other hand, to other services. After 31 December 1993, other cost accounting systems may be applied only if they are suitable for the implementation of paragraph 1 and have as such been approved by the national regulatory authority for application by the telecommunications organization, subject to the Commission being informed prior to their application. 3. The national regulatory authority shall keep available, with an adequate level of detail, information on the cost accounting systems applied by the telecommunications organizations pursuant to paragraph 2. It shall submit this information to the Commission on request. Article 11 Notification and reporting 1. Member States shall notify before 1 January 1993 to the Commission their national regulatory authority as defined in Article 2, fourth indent. 2. The national regulatory authority shall make available statistical reports showing the performance in relation to the supply conditions, in particular with respect to delivery time and repair time, published in accordance with Article 3 at least for each calendar year. The reports shall be sent to the Commission no later than five months after the end of the annual reporting period. The national regulatory authority shall keep available and submit to the Commission on request the data on cases where the access to or use of leased lines has been restricted, in particular because of alleged infringements of special or exclusive rights or the prohibition of simple resale of capacity, as well as details of the measures taken, including their motivation. Article 12 Conciliation procedure Without prejudice to: (a) any action that the Commission or any Member State might take pursuant to the Treaty, and in particular Articles 169 or 170 thereof; (b) the rights of the person invoking the procedure in paragraphs 1 to 5 of this Article of the telecommunications organizations concerned or any other person under applicable national law, except in so far as they enter into an agreement for the resolution of issues between them; the following conciliation procedure shall be available to the user: 1. Any user complaining that he has been or may be injured by the infringement of the provisions of this Directive, particularly regarding intra-Community leased lines, shall have the right to appeal to the national regulatory authority or authorities. 2. Where agreement cannot be reached at a national level, the aggrieved party may invoke the procedure provided for in paragraphs 3 and 4, by way of a written notification to the national regulatory authority and the Commission. 3. Where the national regulatory authority or the Commission finds that there is a case for further examination, following a notification based on paragraph 2, it can refer it to the Chairman of the ONP Committee. 4. In the case referred to in paragraph 3, the Chairman of the ONP Committee shall initiate the procedure described below if he is satisfied that all reasonable steps have been taken at a national level: (a) the Chairman of the ONP Committee shall convene as soon as possible a working group including at least two members of the ONP Committee and one representative of the national regulatory authorities concerned and the Chairman of the ONP Committee or another official of the Commission appointed by him. The working group shall normally meet within 10 days of the meeting being convened. The Chairman may decide, upon proposal of any of the members of the working group, to invite a maximum of two other persons as experts to advise it. (b) the working group shall give the party invoking this procedure, the national regulatory authorities of the Member States, and the telecommunications organizations involved the opportunity to present their opinions in oral or written form; (c) the working group shall endeavour to reach agreement between the parties involved. The Chairman shall inform the ONP Committee of the results of this procedure. 5. The party invoking the procedure referred to in this Article shall bear its own costs of participating in this procedure. Article 13 Deferment of certain obligations 1. When a Member State is not able to or can foresee that it will not be able to fulfil the requirements of Article 7 (1) or (2) or Article 10 (1) or (2), it shall notify the Commission of the reasons. 2. Deferment of the obligations under Article 7 (1) or (2) can be accepted only in cases where the Member State concerned can prove that the actual state of development of its public telecommunications network or the conditions of demand are such that the obligations under Article 7 would impose an excessive burden on the telecommunications organization in that Member State. 3. Deferment of the obligations under Article 10 (1) or (2) can be accepted only in cases where the Member State concerned can prove that the fulfilment of the requirements would impose an excessive burden on the telecommunications organization in that Member State. 4. The Member State shall inform the Commission of the date by which the requirements can be met and of the measures envisaged in order to meet this deadline. 5. When the Commission receives a notification in accordance with paragraph 1, it shall inform the Member State whether it deems that the particular situation of the Member State concerned justifies, on the basis of criteria set out in paragraphs 2 and 3, a deferment for this Member State of the application of Article 7 (1) or (2) of Article 10 (1) or (2) and until which date such deferment is justified. 6. No deferment can be granted in application of paragraph 2 where the non-compliance with Article 7 results from activities of telecommunications organizations of the Member State concerned in competitive areas within the meaning of Community law. Article 14 The Commission shall examine and report to the European Parliament and to the Council on the functioning of this Directive, on the first occasion not later than three years after this Directive is brought into effect. The report shall be based inter alia on the information provided by the Member States to the Commission and to the ONP Committee. Where necessary, further measures can be proposed in the report for the full implementation of the aims of the Directive. Article 15 1. Member States shall take the measures necessary to comply with this Directive before 5 June 1993. 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 inform the Commission of the main provisions of national law which they adopt in the field governed by this Directive. Article 16 This Directive is addressed to the Member States.

31992L0046

1992

Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof, Having regard to the proposals from the Commission (1), Having regard to the opinions of the European Parliament (2), Having regard to the opinions of the Economic and Social Committee (3), Whereas raw milk, heat-treated drinking milk, milk for the manufacture of milk-based products and milk-based products are included in the list of products in Annex II to the Treaty; whereas the production of and trade in such milk and products constitute an important source of income for the agricultural population; Whereas, in order to ensure the rational development of this sector health rules governing the production and placing on the market of milk and milk-based products should be laid down at Community level; Whereas this principle has already been followed in Council Directive 85/397/EEC of 5 August 1985 on health and animal health problems affecting intra-Community trade in heat-treated milk (4); Whereas the introduction of such rules will help to ensure a high level of protection of public health; Whereas the Community has to adopt measures for the gradual establishment of the internal market over a period expiring on 31 December 1992; Whereas it seems necessary to exclude from the scope of this Directive certain products sold directly by the producer to the consumer; Whereas, in order to create the conditions for the internal market, the principles and the rules on checks contained in Directive 89/662/EEC (5) should be extended to all production of milk-based products; Whereas products placed on the Community market which come from third countries must afford the same degree of protection as regards human health; whereas guarantees equivalent to those offered by products of Community origin should therefore be required in respect of such products and they should be subject to the principles and rules on checks contained in Directive 90/675/EEC (6); Whereas the hygiene rules must apply to the production, wrapping, storage and transport of the products covered by this Directive; Whereas in order to ensure uniformity of checks at origin, it is necessary to provide for a procedure for the approval of establishments meeting the health conditions laid down in this Directive, to determine the requirements regarding conditions of hygienic production to be complied with by such establishments and to define the criteria to be met by the products covered by this Directive; Whereas low-capacity establishments should be approved by means of simplified structure and infrastructure criteria, while complying with the rules of hygiene laid down in this Directive; Whereas health marking of milk-based products is the best way of satisfying the competent authority of the place of destination that a consignment complies with the provisions of this Directive; Whereas prime responsibility for compliance with the requirements of this Directive should lie with producers and the competent authority should be obliged to monitor application of this principle of own-checks; Whereas, to ensure uniform application of this Directive, a Community inspection procedure should be established; Whereas, in order to allow the time necessary to set up a Community inspection system to ensure that third countries comply with the guarantees provided for in this Directive, national rules on checks should be maintained for a transitional period as regards third countries; Whereas the extension to all production of milk-based products of the hygiene rules laid down in Directive 85/397/EEC, adapted as necessary in the light of experience, make that Directive redundant; Whereas the existing situation regarding health conditions for stock farms and production and processing structures differs from one Member State to another; Whereas provision should therefore be made for gradual compliance with the standards laid down in this Directive and whereas a distinction should thus be maintained for the time being between trade and the national market; Whereas certain milk-based products may be manufactured from raw milk; whereas, given the nature of these products, it may be necessary to draw up specific conditions applicable thereto and a list of such products as might be marketed; Whereas account should be taken of certain special cheesemaking techniques; Whereas Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (7) and Council Directive 89/396/EEC of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs (8) are applicable; Whereas Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (9), and in particular Annexes I and III thereto, is applicable as regards the maximum residue levels for pharmacologically active substances in milk; Whereas the Commission should be entrusted with the task of adopting certain measures for implementing this Directive; whereas, to that end, a procedure should be laid down establishing close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee; Whereas the adoption of specific rules for the products covered by this Directive is without prejudice to the adoption of rules on food hygiene and safety in general, on which the Commission has submitted a proposal for a framework Directive; Whereas the deadline for transposition into national law, set at 1 January 1992 in Article 32, should not effect the abolition of veterinary checks at frontiers on 1 January 1993, CHAPTER ONE General Rules Article 1 1. This Directive lays down health rules for the production and placing on the market of raw milk, heat-treated drinking milk, milk for the manufacture of milk-based products and milk-based products intended for human consumption. 2. This Directive shall not affect national rules applicable to the direct sale to the consumer by a producer of raw milk obtained from a herd officially free of tuberculosis and officially free or free of brucellosis, or of milk-based products made on his holding with such raw milk, provided that the hygiene conditions of the holding comply with the minimum health rules laid down by the competent authority. (¹) OJ No L 33, 8. 9. 1979, p. 1. Last amended by Commission Directive 91/72/EEC (OJ No L 42, 16. 2. 1991, p. 27). (²) OJ No L 186, 30. 6. 1989, p. 21. Amended by Directive 91/238/EEC (OJ No L 107, 27. 4. 1991, p. 50). (³) OJ No L 224, 18. 8. 1990, p. 1. Last amended by Commission Regulation (EEC) No 675/92 (OJ No L 73, 19. 3. 1992, p. 8). 3. This Directive shall apply, as regards the health rules, without prejudice to: - Council Regulation (EEC) No 804/68 of 28 June 1968 on the common organization of the market in milk and milk products (¹), - Council Directive 76/118/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to certain partly or wholly dehydrated preserved milk for human consumption (²), - Council Directive 83/417/EEC of 25 July 1983 on the approximation of the laws of the Member States relating to certain lactoproteins (caseins and caseinates) intended for human consumption (³), - Council Regulation (EEC) No 1898/87 of 2 July 1987 on the protection of designations used in marketing of milk and milk products (& {È%};). Article 2 For the purposes of this Directive the following definitions shall apply: 1. 'raw milk': milk produced by secretion of the mammary glands of one or more cows, ewes, goats or buffaloes, which has not been heated beyond 40 oC or undergone any treatment that has an equivalent effect; 2. 'milk for the manufacture of milk-based products': either raw milk for processing or liquid or frozen milk obtained from raw milk, whether or not it has undergone an authorized physical treatment, such as heat treatment or thermization, or is modified in its composition, provided that these modifications are restricted to the addition and/or removal of natural milk constituents; 3. 'heat-treated drinking milk': either drinking milk intended for sale to the final consumer and to institutions, obtained by heat treatment and presented in the forms defined in Annex C, Chapter I.A. 4 (a), (b), (c) and (d) or milk treated by pasteurization for sale in bulk at the request of the individual consumer; 4. 'milk-based products': milk products, namely products exclusively derived from milk, it being accepted that substances necessary for their manufacture may be added, provided that these substances are not used to replace in part or in whole any milk constituent, and composite milk products, namely products of which no part replaces or is intended to replace any milk constituent and of which milk or a milk product is an essential part either in terms of quantity or for characterization of the product; 5. 'heat treatment': any treatment involving heating that causes, immediately after it has been applied, a negative reaction to the phosphatase test; 6. 'thermization': the heating of raw milk for at least 15 seconds at a temperature between 57 oC and 68 oC such that after treatment the milk shows a positive reaction to the phosphatase test; 7. 'production holding': an establishment at which one or more milk-producing cows, ewes, goats or buffaloes are kept; 8. 'collection centre': an establishment where raw milk may be collected and possibly cooled and filtered; 9. 'standardization centre': an establishment, which is not attached to a collection centre or a treatment or processing establishment, in which raw milk may be skimmed or the natural constituents modified; 10. 'treatment establishment': an establishment where milk is heat treated; 11. 'processing establishment': an establishment or production holding where milk and/or milk-based products are treated, processed and wrapped; 12. 'competent authority': the central authority of a Member State responsible for carrying out health or public health checks or any authority to which it has delegated that responsibility; 13. 'wrapping': the protection of the products referred to in Article 1 (1) by the use of an initial wrapping or initial container in direct contact with the products concerned as well as the initial wrapper or initial container itself; 14. 'packaging': the placing of one or more wrapped or unwrapped products as referred to in Article 1 (1) in a container, as well as the container itself; 15. 'hermetically sealed container': container which, when sealed, is intended to protect the contents against the entry of micro-organisms during and after heat treatment and which is impervious; 16. 'placing on the market': the stocking or display with a view to sale, offering for sale, sale, delivery or any other manner of disposal in the Community with the exception of retail sale, which must be subject to the checks laid down by national rules for retail business; 17. 'trade': trade between Member States in goods within the meaning of Article 9 (2) of the Treaty. In addition, the definitions in the provisions listed below shall apply as necessary: - Article 2 of Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (10), - Article 2 of Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (11), - Article 3 of Regulation (EEC) No 1411/71 of 29 June 1971 laying down additional rules on the common organization of the market in milk and milk products falling within Common Customs Tariff heading 04-01 (12), and - Article 2 of Regulation (EEC) No 1898/87. CHAPTER II Rules governing Community production Article 3 1. Member States shall ensure that raw milk is not used for the manufacture of milk-based products or heat-treated drinking milk unless it meets the following requirements: (a) it comes from animals and holdings which are checked at regular intervals by the competent authorities, pursuant to Article 13 (1); (b) it is checked in accordance with Article 10 (2) and Articles 14 and 15 and meets the standards laid down in Annex A, Chapter IV; (c) it meets the conditions laid down in Annex A, Chapter I; (d) it comes from holdings which meet the conditions laid down in Annex A, Chapter II; (e) it meets the hygiene requirements defined in Annex A, Chapter III. 2. Member States shall ensure that milk from healthy animals belonging to herds that do not meet the requirements of Annex A, Chapter I (1) (a) (i) and (b) (i) can be used only for the manufacture of heat-treated milk or for the (¹) OJ No L 121, 29. 7. 1964, p. 1977/64. Last amended by Directive 91/499/EEC (OJ No L 268, 24. 9. 1991, p. 107). (²) OJ No L 46, 19. 2. 1991, p. 19. (³) OJ No L 148, 3. 7. 1971, p. 4. Last amended by Regulation (EEC) No 222/88 (OJ No L 28, 1. 2. 1988, p. 1). manufacture of milk-based products after heat treatment under the supervision of the competent authority. In the case of goat's milk and sheep's milk intended for trade, this heat treatment must take place on the spot. Article 4 Member States shall ensure that the placing on the market of raw milk for human consumption in that state is authorized only if such milk meets the following requirements: 1. it complies with the provisions of Article 3, Annex A, Chapter IV.A.3 and Annex C, Chapter II.B.1; 2. where it is not sold to the consumer within two hours after the end of milking, it is cooled in accordance with Annex A, Chapter III; 3. it satisfies the requirements of Annex C, Chapter IV; 4. it satisfies any additional requirements which may be set in accordance with the procedure laid down in Article 31. In the meantime national provisions concerning such requirements shall continue to apply subject to the general provisions of the Treaty. Article 5 Member States shall ensure that heat-treated drinking milk is not placed on the market unless it meets the following conditions: 1. it must have been obtained from raw milk, purified or filtered by the equipment provided for in Annex B, Chapter V (e), which must: (i) comply with Article 3; (ii) in the case of cow's milk, comply with the provisions of Article 3 (1) (b) and Article 6 (3) of Regulation (EEC) No 1411/71; (iii) if appropriate, have passed through a milk-collection centre fulfilling the conditions laid down in Annex B, Chapters I, II, III and VI or have been transferred from one tank to another in good hygiene and distribution conditions; (iv) if appropriate, have passed through a milk-standardization centre fulfilling the conditions laid down in Annex B, Chapters I, II, IV and VI. If appropriate, milk intended for the production of sterilized milk and UHT milk may have undergone an initial heat treatment in an establishment fulfilling the conditions laid down in point 2. The Hellenic Republic shall be authorized to submit pasteurized milk from another Member State to a second pasteurization before placing it on the market; 2. it must come from a treatment establishment which meets the conditions laid down in Annex B, Chapters I, II, V and VI and has been checked in accordance with Article 10 (2) and Article 14; 3. it must have been treated in accordance with Annex C, Chapter I.A; 4. it must meet the standards laid down in Annex C, Chapter II.B; 5. it must be labelled in accordance with Annex C, Chapter IV, and be wrapped in accordance with Annex C, Chapter III, at a treatment establishment where the milk has been subjected to final treatment; 6. it must have been stored in accordance with Annex C, Chapter V; 7. it must be transported under satisfactory conditions of hygiene in accordance with Annex C, Chapter V; 8. it must be accompanied during transport by an accompanying commercial document which must: - in addition to the particulars provided for in Annex C, Chapter IV, bear some indication by which the nature of the heat treatment and the competent authority responsible for supervising the establishment of origin can be identified, if this is not clear from the approval number, - be kept by the consignee for at least one year so that it can be produced at the request of the competent authority, - until 31 December 1997, in the case of heat-treated milk intended for Greece after transit through the territory of a third country, be approved by the competent authority of the border inspection post at which the transit formalities are carried out to certify that the heat-treated milk concerned meets the requirements of this Directive. However, an accompanying document shall not be required in the case of milk transported by the producer for direct delivery to the final consumer; 9. in the case of cow's milk, it must have a freezing point not higher than -0,520 oC and a weight of not less than 1 028 grammes per litre, as determined in whole milk at 20 oC, or the equivalent as determined in totally fat-free milk at 20 oC, and contain a minimum of 28 grammes of protein per litre, obtained by multiplying the percentage total nitrogen content of the milk by 6,38, and a fat-free dry matter content of not less than 8,50 %. No later than 1 January 1994, these requirements will, upon a request from a Member State supported by scientific and statistical studies, be re-examined with a view to their amendment, in accordance with the procedure laid down in Article 31 of this Directive, in the light of seasonal considerations, on the understanding that the relationship between the above parameters must be maintained. Article 6 Member States shall ensure that milk-based products are manufactured only from: 1. either raw milk that complies with the requirements set out in Article 3 and the standards and specifications laid down in Annex C, Chapter I, and if appropriate has passed through a milk-collection or a milk-standardization centre fulfilling the conditions laid down in Annex B, Chapters I, II, III, IV and VI; 2. or milk intended for the manufacture of milk-based products obtained from raw milk which meets the requirements of paragraph 1 and (a) comes from a treatment establishment which meets the requirements of Annex B, Chapters I, II, V and VI; (b) has been stored and transported in accordance with the requirements of Annex C, Chapter V. Article 7 A. Milk-based products must: 1. have been obtained from milk that meets the requirements of Article 6 or from milk-based products that satisfy the requirements of the present Article; 2. be prepared in a processing establishment that meets the standards and specifications of Annex B, Chapters I, II, V and VI and has been checked in accordance with Article 10 (2) and Article 14; 3. meet the standards laid down in Annex C, Chapter II; 4. be wrapped and packaged in accordance with Annex C, Chapter III, and, if they are in liquid form and intended for sale to the final consumer, with point 3 of that Chapter; 5. be labelled in accordance with Annex C, Chapter IV; 6. be stored and transported in accordance with Annex C, Chapter V; 7. be checked in accordance with Article 14 and with Annex C, Chapter VI; 8. where appropriate, contain only substances, other than milk, that are fit for human consumption; 9. have undergone heat treatment during the manufacturing process or be made from products that have undergone heat treatment or involve hygiene specifications that are sufficient to meet the guaranteed hygiene criteria for all finished products. In addition, milk-based products must meet the requirement in Article 5 (8) regarding the accompanying commercial document. B. Pending possible Community rules on ionization, milk and milk-based products intended for trade must not have been subjected to ionizing radiation. Article 8 1. For the manufacture of cheese with a period of ageing or ripening of at least 60 days Member States may grant individual or general derogations as follows: (a) as regards the characteristics of raw milk, from the requirements of Annex A, Chapter IV; (b) provided that the finished product has the characteristics provided for in Annex C, Chapter II.A, from Article 7 A., points 2 and 4; (c) from Annex C, Chapter IV.B.2. General and particular requirements applicable to the manufacture of individual products and standards specific to this type of product shall be adopted, as necessary in accordancy with the procedure laid down in Article 31. 2. In accordance with the procedure laid down in Article 31, Member States may, in so far as certain requirements of this Directive are likely to affect the manufacture of milk-based products with traditional characteristics, be authorized to grant individual or general derogations from Article 7 A.(1) to (4), provided that the milk used in the manufacture of such products meets the requirements of Annex A, Chapter I. Not later than three months before the date specified in Article 32 Member States shall inform the Commission of the list of products in respect of which they are requesting application of the first subparagraph and of the nature of the derogations requested. When the decision provided for in the first subparagraph is taken, the general and particular conditions applicable to the manufacture of each specific product shall, if necessary, be determined. 3. A list of products 'made with raw milk' may be drawn up in accordance with the procedure laid down in Article 31. Article 9 Member States shall ensure that, subject to the provisions of Council Directive 92/47/EEC of 16 June 1992 on the conditions for granting temporary and limited derogations from specific community health rules on the production and marketing of raw milk and milk-based products (13): - treatment or processing establishments receiving raw milk which does not meet the standards laid down in Annex A, Chapter IV, cannot be approved in accordance with Articles 10 or 11 and that products from such establishments do not bear the health mark provided for in Annex C, Chapter IV, A.3, and cannot be the subject of trade, - products which do not meet the standards laid down in Annex C, Chapters I and II, or standards to be fixed pursuant to Article 8 cannot be the subject of trade or be imported from third countries. Article 10 1. Each Member State shall draw up a list of processing establishments and treatment establishments approved by it - other than those referred to in Article 11 - and a list of approved collection centres and standardization centres. Each such establishment or centre shall have an approval number. The competent authority shall not approve the establishments or centres in question unless it is satisfied that they comply with the requirements of this Directive. Where the competent authority finds an obvious failure to comply with the hygiene rules laid down by this Directive or obstacles to an adequate inspection it shall be empowered: (i) to act in respect of the use of equipment or premises and to take any requisite measures which may go as far as limiting or temporarily suspending production; (ii) if the measures provided for in (i) or the measures provided for in the last indent of the second subparagraph of Article 14 (1) have proved insufficient, to temporarily suspend approval, if appropriate, for the type of production in question. If the operator or manager of the establishment or the centre does not make good the shortcoming noted within the period fixed by the competent authority, the latter shall withdraw approval. The competent authority shall in particular be obliged to comply with the conclusions of any check carried out in accordance with Article 14. The other Member States and the Commission shall be informed of the suspension or withdrawal of approval. 2. Inspection and supervision of establishments or centres shall be carried out by the competent authority in accordance with Annex C, Chapter VI. The establishment or centre shall remain under the permanent supervision of the competent authority on the understanding that the need for permanent or periodic presence of the competent authority in a given establishment or centre will depend on the size of the establishment or centre, the type of product manufactured, risk assessment and the guarantees offered in accordance with the fifth and sixth indents of the second subparagraph of Article 14 (1). The competent authority must at all times have free access to all parts of establishments or centres in order to ensure that this Directive is being complied with and, where there is doubt as to the origin of milk or milk-based products, to accounting documents which enable the holding or establishment of origin of the raw material to be traced. The competent authority must regularly analyse the results of the checks provided for in Article 14 (1). It may, on the basis of these analyses, conduct further examinations at all stages of production or on the products. The nature of the checks, their frequency and the methods of sampling and of carrying out microbiological examinations shall be established in accordance with the procedure laid down in Article 31. The results of the analyses shall be written up in a report, the conclusions or recommendations of which shall be notified to the operator or manager of the establishment or centre, who shall rectify the shortcomings noted with a view to improving hygiene. 3. In the event of repeated shortcomings, checks shall be increased and, where appropriate, labels or seals bearing the health mark shall be removed. 4. The detailed rules for the application of this Article shall be adopted in accordance with the procedure laid down in Article 31. Article 11 1. Member States may, when granting approval, grant derogations from the provisions of Article 7 A.(2), Article 14 (2) and Annex B, Chapters I and V, to establishments manufacturing milk-based products whose production is limited. Member States shall communicate to the Commission not later than three months before the date specified in Article 32 the criteria which they have adopted to assess whether an establishment or a category of establishments may benefit from derogations as referred to in the first subparagraph. If, after examination of the criteria adopted or following the checks carried out in accordance with Article 17, the Commission considers that these criteria might jeopardize the uniform application of this Directive, such criteria may be amended or supplemented in accordance with the procedure laid down in Article 31. The conditions under which the competent authority of the Member State shall reclassify the establishments in question shall be laid down by the same procedure. 2. On the basis of the information collected by the Commission in accordance with the second subparagraph of paragraph 1, uniform criteria for the application of this Article shall be established before 1 January 1997 in accordance with the procedure laid down in Article 31. Article 12 Establishments in operation must apply to the competent authority not later than three months before the date specified in Article 32 for classification on the basis of Article 10 or on the basis of Article 11. Until such time as a decision has been taken by the competent authority of the Member State, or until 31 December 1997 at the latest, all products coming from an establishment which has not been classified must not bear the health mark provided for in Annex C, Chapter IV, A.3 and must be marketed at national level. Article 13 1. Member States shall ensure that: - animals on production holdings undergo regular veterinary inspections to ensure that the requirements of Annex A, Chapter I, are being complied with. These inspections may take place on the occasion of veterinary checks carried out pursuant to other Community provisions. If there are grounds for suspecting that the animal health requirements laid down in Annex A are not being complied with, the competent authority shall check the general state of health of the dairy animals and, should it prove necessary, shall have an additional examination of those animals carried out, - production holdings shall undergo regular checks to ensure that hygiene requirements are being complied with. If the inspection or inspections referred to in the first subparagraph show that hygiene is inadequate, the competent authority shall take appropriate steps. 2. Member States shall submit to the Commission the measures which they intend to take for the purposes of the checks provided for in the second indent of the first subparagraph of paragraph 1. The frequency of these checks must take account of the assessment of risk on the production holding concerned. These measures may be amended or supplemented in accordance with the procedure laid down in Article 31 in order to ensure uniform implementation of this Directive. 3. The general hygiene conditions to be complied with by production holdings, in particular the conditions for the upkeep of premises and those relating to milking, shall be adopted in accordance with the procedure laid down in Article 31. Article 14 1. Member States shall ensure that the operator or manager of the treatment and/or processing establishment takes all necessary measures to ensure that, at all stages of production, the relevant specifications of this Directive are complied with. To that end, the operator or manager of the establishment must constantly carry out his own checks based on the following principles: - identification of critical points in the establishment on the basis of the processes used, - monitoring and checking of such critical points by appropriate methods, - taking samples for analysis in a laboratory recognized by the competent authority for the purpose of checking cleaning and disinfection methods and for the purpose of checking compliance with the standards established by this Directive, - keeping a written or registered record of the information required in accordance with the preceding indents with a view to submitting it to the competent authority. The results of the different checks and tests shall in particular be kept for a period of at least two years, save in the case of milk-based products which cannot be stored at ambient temperature, for which this period shall be reduced to two months after the use-by or minimum durability date, - when the laboratory examination or any other information at their disposal reveals that there is a serious health risk, inform the competent authority thereof, - in the event of an immediate human health risk, withdraw from the market the quantity of products obtained in technologically similar conditions and likely to present the same risk. This withdrawn quantity must stay under the supervision and control of the competent authority until it is destroyed, used for purposes other than human consumption or, after authorization by the competent authority, reprocessed in an appropriate manner to ensure its safety. In addition, the operator or manager of the establishment must guarantee the correct administration of the health marking. The requirements of the second subparagraph, first and second indents, and of the third subparagraph must have been communicated to the competent authority, which must regularly monitor compliance therewith. 2. The operator or manager of the establishment must apply or organize a staff training programme enabling workers to comply with conditions of hygienic production adapted to the production structure, unless such staff already have adequate qualifications attested by diplomas. The competent authority responsible for the establishment must be involved in the planning and implementation of the programme or, in the case of a programme already in existence on the date of notification of this Directive, in the monitoring of the programme. 3. Where there are reasonable grounds for suspecting that the requirements of this Directive are not being complied with, the competent authority shall carry out the necessary checks and, if that suspicion is confirmed, take appropriate measures, up to and including the suspension of approval. 4. The detailed rules for the application of this Article shall, if necessary, be determined in accordance with the procedure laid down in Article 31. Article 15 1. By 30 June 1993 at the latest Member States shall submit to the Commission, in accordance with the principles and rules of Council Directive 86/469/EEC of 16 September 1986 concerning the examination of animals and fresh meat for the presence of residues (14), the national measures to be implemented to extend to raw milk, heat-treated milk and milk-based products examination for: - residues in group III (antibiotics, sulphonamides and similar anti-microbial substances) in Annex I, A. to that Directive, - residues in group II (other residues) in Annex I, B. to that Directive. 2. Member States shall ensure that in the context of the checks provided for in Article 14 tests are carried out to detect any residues of substances having a pharmacological or hormonal action, and of antibiotics, pesticides, detergents and other substances which are harmful or which might alter the organoleptic characteristics of milk or milk-based products or make their consumption dangerous or harmful to human health, insofar as those residues exceed the permitted tolerance limits. If the milk or milk-based products examined show traces of residues which exceed the permitted tolerances, they must be excluded from human consumption. Examinations for residues must be carried out in accordance with proven methods which are scientifically recognized, and in particular those laid down at Community or international level. 3. The competent authority shall make spot checks on compliance with the requirements of pharagraph 2. 4. The following shall be established in accordance with the procedure laid down in Article 31: - the detailed rules for and the frequency of the checks provided for in paragraph 3, - the tolerances and reference methods provided for in paragraph 2. In accordance with the same procedure, a decision may be taken to extend the examinations to substances other than those referred to in paragraph 1. 5. Until the entry into force of the implementing measures for this Article, national rules shall remain applicable, subject to the general provisions of the Treaty. Article 16 1. Milk tanks, premises, installations and working equipment may be used for other foodstuffs provided that all appropriate measures are taken to prevent contamination or deterioration of drinking milk or milk-based products. 2. Tanks used for milk must bear a clear indication that they may be used only for the transport of foodstuffs. 3. Where establishments produce foodstuffs containing milk or milk-based products together with other ingredients which have not undergone heat treatment or another treatment having an equivalent effect, such milk, milk-based products and ingredients must be stored separately to prevent cross-contamination, and treated or processed in premises suitable for the purpose. 4. The detailed rules for the application of this Article, and in particular the conditions relating to washing, cleaning and disinfecting before reuse, and the conditions of transport, shall be adopted in accordance with the procedure laid down in Article 31. Article 17 Experts from the Commission may, in so far as is necessary for the uniform application of this Directive and in cooperation with the competent authorities, make on-site checks. In particular, they may verify by checking a representative percentage of establishments whether the competent authorities are ensuring that approved establishments are complying with this Directive. The Commission shall inform the Member States of the results of the checks carried out. A Member State in whose territory a check is being carried out shall give all the necessary assistance to the experts in carrying out their duties. The detailed rules for the application of this Article shall be adopted in accordance with the procedure laid down in Article 31. Article 18 Member States shall ensure that the manufacture of products covered by this Directive in which some milk constituents are replaced by products other than milk-based products is subject to the hygiene rules laid down in this Directive. Article 19 1. The provisions of Directive 89/662/EEC shall apply, in particular with respect to the organization of and the action to be taken on the checks carried out by the Member State of destination and the safeguard measures to be taken. 2. Without prejudice to the specific provisions of this Directive, the competent authority shall, where it is suspected that this Directive is not being complied with or there is doubt as to whether the products referred to in Article 1 are fit for consumption, carry out any checks it deems appropriate. 3. Member States shall take the appropriate administrative or penal measures to penalize any infringement of this Directive, in particular where it is found that the certificates or documents drawn up do not correspond to the actual state of the products referred to in Article 1, that the marks on the products concerned do not comply with the rules, that the products have not undergone the checks provided for in this Directive or that they were not used for the purpose originally intended. Article 20 1. In accordance with the procedure laid down in Article 31, the following may be established: - the requirements applicable to any product with authorization to be placed on the market in a Member State but whose composition or presentation might give rise to differing interpretation in different Member States, - the methods for checking that the hermetically sealed containers are impervious, - the reference methods and, where necessary, the criteria governing routine methods of analysis and testing to be used to monitor compliance with the requirements of this Directive, and the methods of sampling, - limits and methods to enable a distinction to be made between different types of heat-treated milk as defined in Annex C, Chapter I, - the methods of analysis for the standards referred to in Annex A, Chapter IV, and in Annex C, Chapter I and II. Pending the decisions referred to in the first subparagraph, any internationally accepted analysis and test methods shall be recognized as reference methods. 2. By way of derogation from Articles 3 and 6, it may be decided, in accordance with the procedure laid down in Article 31, that some provisions of this Directive shall not apply to milk-based products containing other foodstuffs, where percentage of milk or milk-based product is not essential within the meaning of Article 2 (4). The derogations referred to in the first subparagraph may not relate to: (a) the animal health requirements laid down in Annex A, Chapter I and the conditions for approval of establishments laid down in Annex B, Chapter I; (b) the marking requirements laid down in Annex C, Chapter IV; (c) the inspection requirements laid down in Annex C, Chapter VI. In granting derogations both the nature and the composition of the product shall be taken into account. 3. Notwithstanding paragraph 2, Member States shall ensure that all milk-based products placed on the market are wholesome products prepared from milk or from milk-based products meeting the requirements of this Directive. Article 21 The Council, acting by a qualified majority on a proposal from the Commission, shall amend the Annexes as necessary, in particular to adapt them to take account of scientific and technological progress. CHAPTER III Imports from third countries Article 22 The conditions applicable to imports from third countries of raw milk, heat-treated milk and milk-based products covered by this Directive must be at least equivalent to those laid down in Chapter II for Community production. Article 23 1. For the purposes of uniform application of Article 22, the provisions of the following paragraphs shall apply. 2. In order to be imported into the Community, milk or milk-based products must: (a) come from a third country on the list to be drawn up in accordance with paragraph 3 (a); (b) be accompanied by a health certificate corresponding to a specimen to be drawn up in accordance with the procedure laid down in Article 31, signed by the competent authority of the exporting country and certifying that the milk or milk-based products meet the requirements of Chapter II or any additional conditions or offer the equivalent guarantees referred to in paragraph 3 and come from establishments offering the guarantees provided for in Annex B. 3. The following shall be established in accordance with the procedure laid down in Article 31: (a) a provisional list of third countries or parts of third countries able to provide Member States and the Commission with guarantees equivalent to those provided for in Chapter II and a list of the establishments for which they are able to give these guarantees. This provisional list shall be compiled from the lists of establishments approved and inspected by the competent authorities, once the Commission has checked that these establishments comply with the principles and general rules laid down in this Directive; (b) updates of that list in the light of the checks provided for in paragraph 4; (c) the specific requirements and equivalent guarantees established for third countries, which may not be more favourable than those provided for in Chapter II; (d) the types of heat treatment to be prescribed for certain third countries presenting an animal health risk. 4. Experts from the Commission and the Member States shall carry out on-the-spot inspections to verify whether the guarantees given by the third country regarding the conditions of production and placing on the market can be considered equivalent to those applied in the Community. The experts from the Member States responsible for these inspections shall be appointed by the Commission, acting on a proposal from the Member States. These inspections shall be made on behalf of the Community, which shall bear the cost of any expenditure in this connection. The frequency of and procedure for these inspections, including those to be carried out in the event of a decision in accordance with paragraph 6, shall be determined in accordance with the procedure laid down in Article 31. 5. Pending the organization of the inspections referred to in paragraph 4, national rules applicable to inspection in third countries shall continue to apply, subject to notification, through the Standing Veterinary Committee, of any failure to comply with hygiene rules found during these inspections. 6. The Council, acting by a qualified majority on a proposal from the Commission, may replace individual recognition of treatment or processing establishments by recognition, on a reciprocal basis, of establishments in a third country which are subject to effective, regular inspection by the competent authority such that the said authority is able to guarantee compliance with the requirements of paragraph 2(b). Article 24 The principles and general rules laid down in Directive 90/675/EEC shall apply, with particular reference to the organization of and follow up to the inspections to be carried out by the Member States and the safeguard measures to be implemented. Article 25 1. Member States shall ensure that the products covered by this Directive are imported into the Community only if: - they are accompanied by a certificate to be issued by the competent authority of the third country at the time of loading. The specimen certificate shall be drawn up in accordance with the procedure laid down in Article 31, - they have satisfied the checks required by Directive 90/675/EEC and 91/496/EEC (15). 2. Pending the establishment of detailed rules for the application of this Article, the national rules applicable to imports from third countries for which such requirements have not been adopted at Community level shall continue to apply, provided they are not more favourable than those laid down in Chapter II. Article 26 The lists provided for in Article 23 may include only third countries or parts of third countries: (a) from which imports are not prohibited as a result of the existence of diseases as referred to in Annex A or of any other disease exotic to the Community or pursuant to Articles 6, 7 and 14 of Directive 72/462/EEC (16); (b) which, in view of their legislation and the organization of their competent authority and of their inspection services, the powers of such services and the supervision to which they are subject, have been recognized, in accordance with Article 3 (2) of Directive 72/462/EEC, as capable of guaranteeing the implementation of their legislation in force; (c) the veterinary services of which are able to guarantee that health requirements at least equivalent to those laid down in Chapter II are being complied with. CHAPTER IV Final provisions Article 27 1. Each Member State shall designate one or more national reference laboratories for the analysis and testing of milk and milk-based products, and shall forward a list thereof to the Commission. These laboratories shall be responsible for: - coordinating the activities of the laboratories whose task it is to conduct analyses to check the chemical or bacteriological standards and to conduct the tests provided for in this Directive, - assisting the competent authority in organizing the system of checking milk and milk-based products, - periodically organizing comparative tests, - disseminating the information supplied by the Community reference laboratory referred to in Article 28 to the competent authorities and the laboratories carrying out analyses and tests on milk and milk-based products. (²) Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat from third countries (OJ No L 302, 31. 12. 1972, p. 28). Last amended by Directive 91/497/EEC (OJ No L 268, 24. 9. 1991, p. 69). 2. The Commission shall publish the list of national reference laboratories and updates thereof in the Official Journal of the European Communities. Article 28 The Community reference laboratory for the analysis and testing of milk and milk products is indicated in Annex D, Chapter I. The duties and tasks of that laboratory are set out in Chapter II of that Annex and include the coordination of the activities of the national reference laboratories referred to in Article 27. Article 28 of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (17) shall apply. Article 29 1. Directive 85/397/EEC is hereby repealed with effect from 1 January 1994. 2. Council Directive 89/384/EEC of 20 June 1989 establishing the detailed procedures for carrying out checks to ensure that the freezing point of untreated milk laid down in Annex A of Directive 85/397/EEC (18) is complied with, Commission Directive 89/362/EEC of 26 May 1989 on general conditions of hygiene in milk production holdings (19) and Commission Decision 91/180/EEC of 14 February 1991 laying down certain methods of analysis and testing of raw milk and heat-treated milk (20) shall continue to apply for the purposes of the present Directive. In accordance with the procedure laid down in Article 31, these acts may be amended to adapt the scope thereof to the content of the present Directive or to adapt them subsequently to advances in science and technology. Article 30 Directive 89/662/EEC shall be amended as follows: 1. the following indent shall be added to Annex A: '- Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products (OJ No L 268, 14. 9. 1992, p. 1).'; 2. the following indent shall be deleted from Annex A: '- Council Directive 85/397/EEC of 5 August 1985 on health and animal health problems affecting intra-Community trade in heat-treated milk (OJ No L 226, 24. 8. 1985, p. 13), as last amended by Regulation (EEC) No 3768/85 of 20 December 1985 (OJ No L 362, 31. 12. 1985, p. 8).'; 3. the following indent shall be deleted from Annex B: '- raw milk and milk-based products.'. Article 31 1. Where the procedure laid down in this Article is to be followed, matters shall without delay be referred to the Standing Veterinary Committee set up by Decision 68/361/EEC (21), hereinafter referred to as 'the Committee', by its Chairman, either on his own initiative or at the request of the representative of a Member State. 2. The representatives of the Commission, after consulting the Management Committee for Milk and Milk Products established by Regulation (EEC) No 804/68 where matters of chemistry or technology are involved, shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on such measures within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. Within the Committee the votes of the representatives of the Member States shall be weighted in the manner set out in Article 148 (2) of the Treaty. The Chairman shall not vote. 3. (a) The Commission shall adopt the measures envisaged and implement them immediately if they are in accordance with the opinion of the Committee. (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 relating to the measures to be taken. The Council shall act by a qualified majority. If, within three months of the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, except where the Council has rejected those measures by a simple majority. Article 32 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1994. 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 main provisions of national law which they adopt in the field governed by this Directive. 3. The setting of the deadline for transposition into national law at 1 January 1994 shall be without prejudice to the abolition of veterinary checks at frontiers provided for in Directive 89/662/EEC. Article 33 This Directive is addressed to the Member States.

31992L0045

1992

Council Directive 92/45/EEC of 16 June 1992 on public health and animal health problems relating to the killing of wild game and the placing on the market of wild-game meat Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 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 game meat is included in the list of products in Annex II to the Treaty; whereas the placing on the market of wild game meat constitutes an additional source of income for part of the farming population; Whereas, in order to ensure the rational development of this sector and to improve productivity, rules concerning public health and animal health problems affecting the production and placing on the market of wild game meat must be laid down at Community level; Whereas disparities as regards animal health and public health conditions in the Member States should be eliminated in order to encourage intra-Community trade in such meat, with a view to the completion of the internal market; Whereas diseases communicable to domestic animals and humans may be spread by such meat; whereas it is necessary to lay down rules enabling these risks to be controlled; Whereas it is necessary to lay down the hygiene conditions in which wild game meat must be obtained, processed and inspected, in order to prevent food-borne infections or food poisoning; Whereas it is necessary to stipulate the hygiene rules to be complied with by wild game processing houses for the purposes of approval for trade; Whereas, in respect of the organization of, and the follow-up to, the checks to be carried out by the Member State of destination and the safeguard measures to be implemented, reference should be made to general rules laid down in Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (4); Whereas wild game and wild-game meat imported from third countries should be subject to the minimum requirements laid down by this Directive for trade between Member States, and compliance therewith should be monitored in accordance with the principles and rules set out in Directive 90/675/EEC (5); Whereas it is appropriate to permit derogations for small quantities of wild game meat; Whereas it is appropriate to grant temporary derogations to allow wild game processing houses to comply with the new requirements; Whereas the Commission should be charged with adopting measures to implement this Directive; whereas, to that end, a procedure should be set up establishing close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee; Whereas the deadline for transposition into national law, set at 1 January 1994 in Article 23, should not affect the abolition of veterinary checks at frontiers on 1 January 1993, CHAPTER I General provisions Article 1 1. This Directive lays down public health and animal health rules applicable to the killing of wild game and to the preparation and placing on the market of wild game meat. (& {È%};) OJ No L 395, 30. 12. 1989, p. 13. Last amended by Directive 91/496/EEC (OJ No L 268, 24. 9. 1991, p. 56). (& {È& };) Council Directive 90/675/EEC of 10 December 1990, laying down the principles governing the organization of veterinary checks on products entering the Community from third countries (OJ No L 373, 31. 12. 1990, p. 1). Amended by Directive 91/496/EEC (OJ No L 268, 24. 9. 1991, p. 56). 2. This Directive shall not apply to: (a) small numbers of wild game, unskinned or unplucked, and, in the case of small wild game, ineviscerated, supplied directly by the hunter to the consumer or to the retailer; (b) small quantities of wild-game meat supplied directly to the final consumer; (c) the cutting and storage of wild-game meat in retail shops or in premises adjacent to sales points, where the cutting and storage are performed solely for the purpose of supplying the consumer directly on the spot. The above operations shall continue to be subject to the public health checks provided for in national rules governing retailing. 3. The provisions of this Directive concerning trade or imports from third countries shall not apply to trophies or to killed wild game carried by travellers in their private vehicle provided that only a small quantity of small wild game or a single large wild game animal is involved and the circumstances indicate that there is no question of the meat of such game being intended for trade or commercial use, and provided that the game in question does not come from a country or a part of a country trade from which is prohibited pursuant to Article 11 (2) and 3 or Article 18. Article 2 1. For the purposes of this Directive, the following definitions shall apply: (a) 'wild game': wild land mammals which are hunted (including wild mammals living within an enclosed area under conditions of freedom similar to those enjoyed by wild game) and wild birds which are not covered by Article 2 of Council Directive 91/495/EEC of 27 November 1990, concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat (6); (b) 'large wild game': wild ungulates; (c) 'small wild game': wild mammals of the Leporidae family and wild game birds intended for human consumption; (d) 'wild-game meat': all parts of wild game which are fit for human consumption; (e) 'wild game processing house': an establishment approved in accordance with Article 7 in which wild game is processed and wild game meat is obtained and inspected in accordance with the hygiene rules laid down in this Directive; (f) 'collection centre': any place where killed wild game is kept in accordance with the hygiene rules in Annex I, Chapter IV (2) prior to being transported to a processing house; (g) 'placing on the market': holding or displaying for sale, offering for sale, selling, delivering or any other form of placing on the market of wild game meat for human consumption in the Community, excluding supplies pursuant to Article 1 (2); (h) 'trade': trade between Member States within the meaning of Article 9 (2) of the Treaty. 2. For the purposes of this Directive the definitions in Article 2 of Directive 89/662/EEC and Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (7), and the definition of fresh meat in Article 2 (b) of Council Directive 64/433/EEC of 26 June 1964 on health problems affecting intra-Community trade in fresh meat (8), shall apply as necessary. CHAPTER II Provisions applicable to Community production and trade Article 3 1. Member States shall ensure that wild game meat: (a) comes from wild game which: - has been killed in a hunting area by means authorized under national legislation governing hunting, - does not come from a region subject to restrictions pursuant to Council Directive 72/461/EEC of 12 December 1972 on health problems affecting intra-Community trade in fresh meat (& {È%};), Council Directive 91/494/EEC of 26 June 1991 on animal health conditions governing intra-Community trade in and imports from third countries of fresh poultrymeat (& {È& };) and Council Directive 91/495/EEC or from a hunting area subject to restrictions pursuant to Articles 10 and 11 of this Directive, - immediately after killing has been prepared in accordance with Annex I, Chapter III, and transported within a maximum of 12 hours to a processing house as referred to in (b) or to a (²) OJ No L 224, 18. 8. 1990, p. 29. Last amended by Directive 91/496/EEC (OJ No L 268, 24. 9. 1991, p. 56). (³) OJ No L 121, 29. 7. 1964, p. 2012/64. Last amended by Directive 91/497/EEC (OJ No L 268, 24. 9. 1991, p. 69). (& {È%};) OJ No L 302, 31. 12. 1972, p. 24. Last amended by Directive 91/266/EEC (OJ No L 134, 29. 5. 1991, p. 45). (& {È& };) OJ No L 268, 24. 9. 1991, p. 35. collection centre where it must be chilled to the temperatures specified in Annex I, Chapter III, and from which it must be taken to a processing house as referred to in (b) within 12 hours or, in the case of remote regions where climatological conditions so permit, within a period to be fixed by the competent authority to enable the official veterinarian of the said processing house to carry out the post mortem inspection provided for in Annex I, Chapter V, under satisfactory conditions; (b) is obtained: (i) either in a wild game processing house fulfilling the general conditions of Annex I, Chapters I and II, and approved for the purposes of the present Chapter in accordance with Article 7; (ii) in the case of large wild game, in an establishment approved in accordance with Article 10 of Directive 64/433/EEC, or, in the case of small wild game, in accordance with Article 5 of Council Directive 71/118/EEC of 15 February 1971 on health problems affecting trade in fresh poultrymeat (¹) provided that: - such game is skinned in rooms separate from those reserved for meat covered by those Directives, or at different times, - such establishments are given special approval for the purposes of this Directive, - measures are taken to allow clear identification of meat obtained pursuant to the present Directive and meat obtained pursuant to Directives 64/433/EEC and 71/118/EEC; (c) comes from killed animals which have undergone visual inspection by the official veterinarian: - to detect any anomalies. The official veterinarian may base his diagnosis on any information supplied by the hunter, where appropriate on the basis of a certificate laid down by the authority responsible for hunting rules, on the behaviour of the animal before killing, - to check that death is not due to causes other than hunting; (d) comes from wild game which: - has been handled under satisfactory hygiene conditions, in accordance with Annex I, Chapters III and IV, - has undergone, in accordance with Annex I, Chapter V, post-mortem inspection by an official veterinarian or, by auxiliaries holding the professional qualifications to be specified in (¹) OJ No L 55, 8. 3. 1971, p. 23. Last amended by Directive 90/654/EEC (OJ No L 353, 17. 12. 1990, p. 48). accordance with the procedure laid down in Article 22, acting under the supervision of the official veterinarian, - has not shown any change except for traumatic lesions which occurred during killing or localized malformations or changes, provided that it is established, if necessary by appropriate laboratory tests, that these do not render the meat unfit for human consumption or dangerous to human health, - on which, in the case of small wild game which has not immediately after killing been eviscerated in accordance with Annex I, Chapter V (1), an official veterinary health inspection has been carried out on a representative sample of animals from the same source. If the official veterinarian finds a disease communicable to man or defects as referred to in Annex I, Chapter V (4), he must carry out more checks on the entire batch. In the light of the results of these further checks, he must either exclude the entire batch from human consumption or inspect each carcase individually. 2. The official veterinarian must ensure that wild game meat is excluded from human consumption: (i) if it is found to contain defects as referred to in Annex I, Chapter V (3) (e), or if it has been seized in accordance with paragraph 4 of that Chapter; (ii) if the checks provided for in the third indent of paragraph 1 (d) of this Article have revealed the presence of a disease communicable to man; (iii) if it comes from animals which have ingested substances which are likely to make the meat dangerous or harmful to human health and on which a decision has been taken, by the procedure laid down in Article 22, after the opinion of the Scientific Veterinary Committee has been obtained. Pending the implementation of such a decision, national rules on these substances shall remain in force, subject to the general provisions of the Treaty; (iv) if, without prejudice to any Community legislation applicable to ionization, it has been treated with ionizing or ultra-violet radiation or by means of substances likely to affect its organoleptic properties or using colourings other than those used for health marking. 3. Meat of wild boar or of other species susceptible to trichinosis must undergo analysis by the digestion method in accordance with Council Directive 77/96/EEC of 21 December 1976 on the examination for trichinae (trichinella spiralis) upon importation from third countries of fresh meat derived from domestic swine (²) or a trichinoscopic examination with microscopic observation of several samples from each animal taken from the jaw and diaphragmatic muscles, from the muscles of the lower front (²) OJ No L 26, 31. 1. 1977, p. 67. Last amended by Directive 89/321/EEC (OJ No L 133, 17. 5. 1989, p. 33). leg, from the intercostal muscles and the tongue muscles at least. Before 1 January 1994, the Council, acting by a qualified majority on a proposal from the Commission and after obtaining the opinion of the Scientific Veterinary Committee, shall lay down the methods for the analysis by digestion which are suitable for detecting trichinosis in wild boar or other species of wild game susceptible to trichinosis; the same procedure shall apply with regard to the trichinoscopic or microscopic examination for the detection of trichinosis. 4. Wild game meat declared fit for human consumption must: (i) bear a health mark in accordance with Annex I, Chapter VIII. A decision may be taken, where appropriate, to amend or supplement the provisions of the aforementioned Chapter in accordance with the procedure provided for in Article 22, in order to take into account notably the different forms of commercial presentation, providing they conform to the hygiene rules laid down in this Directive. Commission Directive 80/879/EEC of 3 September 1980 on health marking of large packagings of fresh poultrymeat (¹) shall apply to meat of small wild game; (ii) after post-mortem inspection, be stored in accordance with Annex I, Chapter X, under satisfactory hygiene conditions in wild game processing houses approved in accordance with Article 7 of this Directive, or in establishments approved in accordance with Article 10 of Directive 64/433/EEC or Article 5 of Directive 71/118/EEC, or in cold stores approved and inspected in accordance with Article 10 of Directive 64/433/EEC; (iii) be accompanied during transportation by: - an accompanying commercial document as authorized by the official veterinarian. This document must: - in addition to the particulars provided for in Annex I, Chapter VII (2), including in the case of frozen meat the month and year of freezing in clear, bear a code number by which the official veterinarian can be identified, - be kept by the consignee for at least one year so that it can be produced at the request of the competent authority. Detailed rules for applying this point, and in particular those concerning the allocation of code numbers and the compilation of one or more lists identifying the official veterinarians, shall be adopted in accordance with the procedure laid down in Article 22, - a public animal health certificate corresponding to the specimen in Annex II, in the case of meat from a wild game processing house situated in a restricted region or area or meat to be sent to another Member State after transit through a third country in a sealed lorry; (¹) OJ No L 251, 24. 9. 1980, p. 10. (iv) be transported under satisfactory hygiene conditions in accordance with Annex I, Chapter XI; (v) in the case of parts of carcases or boned meat of small wild game birds, also be obtained in conditions similar to those provided for in Article 3 B. of Directive 71/118/EEC, in establishments specially approved for this purpose in accordance with Article 7 of the present Directive; (vi) without prejudice to Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (²), be labelled with an indication of the animal species. Article 4 1. Member States shall ensure that: (a) meat declared unfit for human consumption can be clearly distinguished from meat declared fit for human consumption; (b) meat declared unfit for human consumption is treated in accordance with Council Directive 90/667/EEC of 27 November 1990 laying down the veterinary rules for the disposal and processing of animal waste, for its placing on the market and for the prevention of pathogens in feedstuffs of animal or fish origin and amending Directive 90/425/EEC (9). 2. Meat from an area subject to animal health restrictions shall be subject to specific rules to be determined on a case-by-case basis in accordance with the procedure laid down in Article 22. 3. Detailed rules for implementing this Article shall if necessary be determined in accordance with the procedure laid down in Article 22. Article 5 Member States shall ensure that only the following are the subject of trade: 1. skinned and eviscerated wild game meeting the requirements of Articles 3 and 4, or fresh wild game meat; 2. unskinned or unplucked and uneviscerated small game, not frozen or deep-frozen which is controlled in accordance with the third indent of Article 3 (1) (b) (ii), provided it is handled and stored separately from fresh meat covered by Directive 64/433/EEC, poultry meat and skinned or plucked game meat; 3. unskinned large game which: (a) meets the requirements of Article 3 (1) (a) first and second indents, Article 3 (1) (c), and Article 3 (1) (d) first indent; (b) the viscera of which have undergone post-mortem inspection in a wild game processing house; (c) is accompanied by a health certificate corresponding to a specimen to be drawn up in accordance with the procedure laid down in Article 22, signed by the official veterinarian to certify that the result of the post mortem inspection provided for in (b) was satisfactory and that the meat has been declared fit for human consumption; (d) has been cooled to a temperature of between -1 oC and: (i) +7 oC and kept at that temperature during transportation to a processing house within a maximum period of seven days from the post mortem inspection referred to in (b), or (ii) +1 oC and kept at that temperature during transportation to a processing house within a maximum period of 15 days from the post-mortem inspection referred to in (b). Meat from such unskinned wild game cannot bear the health mark provided for in Article 3 (4) (i) unless, after skinning in the processing house of destination, it has undergone post mortem inspection in accordance with Annex I, Chapter V, and has been declared fit for human consumption by the official veterinarian. Article 6 Member States shall ensure that: - wild game processing houses which do not meet the standards laid down in Annex I, Chapter I, and which are not covered by the derogations provided for in Article 8 cannot be approved in accordance with Article 7 and that products from such establishments do not bear the health mark provided for in Annex I, Chapter VII and cannot be the subject of trade, - wild game which does not meet the requirements of Article 3 cannot be the subject of trade or be imported from third countries, - offal of wild game declared fit for human consumption cannot be the subject of trade unless it has undergone appropriate treatment in accordance with Council Directive 77/99/EEC on health problems affecting intra-Community trade in meat products (10). Article 7 1. Each Member State shall draw up a list of approved wild game processing houses, each having a veterinary approval number. Member State may approve, for the processing of wild game, establishments approved in accordance with Directive 64/433/EEC and 71/118/EEC, provided that such establishments are equipped to process wild game meat and that they work in conditions ensuring compliance with the hygiene rules. Member States shall send this list to the other Member States and to the Commission. A Member State shall not approve a wild game processing house unless it is satisfied that it complies with this Directive. Where hygiene is found to be inadequate and where the measures provided for in Annex I, Chapter V (5), second subparagraph have proved insufficient to remedy the situation, the competent authority shall temporarily suspend approval. If the operator or manager of the wild game processing house does not make good the shortcomings noted within the period fixed by the competent authority, the latter shall withdraw approval. The Member State in question shall take account of the conclusions of any check carried out in accordance with Article 12. The other Member States and the Commission shall be informed of the suspension or withdrawal of approval. 2. The operator or manager of the wild game processing house must, in accordance with paragraph 4, conduct regular checks on the general hygiene of conditions of production in his establishment, inter alia, by means of microbiological controls. Checks must cover utensils, fittings and machinery at all stages of production and, if necessary, products. The operator or manager of the wild game processing house must inform the official veterinarian or the Commission's veterinary experts of the nature, frequency and results of the checks conducted to this end, together with the name of the investigating laboratory if need be. The nature of the checks, their frequency, as well as the sampling methods and the methods for bacteriological examination shall be established in accordance with the procedure laid down in Article 22. 3. The operator or manager of the wild game processing house must establish a staff training programme enabling workers to comply with conditions of hygienic production adapted to the production structure. The official veterinarian responsible for the wild game processing house must be involved in the planning and implementation of that programme. 4. Inspection and supervision of wild game processing houses shall be carried out under the responsibility of the official veterinarian, who may be assisted by auxiliaries in accordance with Article 9 of Directive 64/433/EEC. The official veterinarian must at all times have free access to all parts of processing houses in order to ensure that this Directive is being complied with and, where there is doubt as to the origin of meat or killed wild game, to relevant documents which enable him to trace the hunting area of origin. The official veterinarian must regularly analyse the results of the checks provided for in paragraph 2. He may, on the basis of this analysis, conduct further microbiological examinations at all stages of production or on the products. The result of these analyses shall be written up in a report, the conclusions and recommendations of which shall be notified to the operator or manager of the establishment, who shall rectify the shortcomings noted with a view to improving hygiene. Article 8 1. Member States may, until 31 December 1996, authorize wild game processing houses which, on the date on which this Directive is notified, have not been judged to comply with the conditions for approval, to derogate from some of the requirements laid down in Annex I provided that meat from such establishments bears the national mark. 2. Derogations as referred to in paragraph 1 may be granted only to processing houses which have, before 1 April 1993, submitted an application for a derogation to the competent authority. This application must be accompanied by a work plan and programme indicating the period within which it would be possible for the processing house to comply with the requirements referred to in paragraph 1. 3. Member States shall communicate to the Commission before 1 October 1992 the criteria which they have adopted to determine whether an establishment or category of establishments is covered by the provisions of this Article. Article 9 Member States shall entrust to a central service or body the tasks of collecting and making use of the results of the post-mortem inspection carried out by the official veterinarian as regards the diagnosis of diseases communicable to man. Whereas such a disease is diagnosed, the results of the specific case shall be communicated as soon as possible to the competent veterinary authorities responsible for supervision of the hunting area where the wild game in question originated. Member States shall submit to the Commission information on certain diseases and particularly cases where diseases communicable to man have been diagnosed. The Commission acting in accordance with the procedure laid down in Article 22, shall adopt detailed rules for implementing this Article, and in particular: - the frequency with which information must be submitted to the Commission, - the type of information, - the disease to which the collection of information is to apply, - procedures for collecting and using information. Article 10 1. Member States shall ensure that a survey of the health of wild game is performed in hunting areas on their territories at regular intervals. 2. To this end a central service or body shall be entrusted with the task of collecting and using the results of the health inspections carried out in accordance with this Directive, where diseases communicable to man or to animals or the presence of residues in excess of permitted levels are diagnosed. 3. Where a disease or condition as referred to in paragraph 2 is diagnosed, the survey results relating to the specific case shall be communicated as soon as possible to the competent authority responsible for supervision of the hunting area. 4. Depending on the epizootic situation, the competent authority shall carry out specific tests on wild game in order to detect the presence of the diseases referred to in Annex I to Council Directive 82/894/EEC of 21 December 1982 on the notification of animal diseases within the Community (11). The presence of these diseases shall be communicated to the Commission and to the other Member States in accordance with the said Directive. Article 11 1. Member States shall supplement their plans for measures to detect residues referred to in Article 4 of Council Directive 86/469/EEC of 16 September 1986 concerning the examination of animals and fresh meat for the presence of residues (12) in order, where necessary, to subject wild game meat to the inspections provided for in that Directive in order to make spot checks on the presence of contaminants in the environment. 2. Taking into account the results of the monitoring referred to in paragraph 1 and in Article 10 (4), Member States shall ensure that wild game and wild game meat from hunting areas implicated by the monitoring is excluded from trade. 3. The Commission shall adopt detailed rules for implementing this Article in accordance with the procedure laid down in Article 22. Article 12 Veterinary experts from the Commission may, in so far as is necessary for the uniform application of this Directive and in cooperation with the competent national authorities, make on-site checks. In particular, they may verify by checking a representative percentage of wild game processing houses whether the competent authorities are ensuring that approved processing houses are complying with this Directive. The Commission shall inform the Member States of the results of the checks carried out. A Member State in whose territory a check is being carried out shall give all the necessary assistance to the experts in carrying out their duties. Detailed rules for implementing this Article shall be adopted in accordance with the procedure laid down in Article 22. Article 13 1. With prejudice to the specific provisions of this Directive, the official veterinarian or the competent authority shall, where it is suspected that veterinary legislation has not been complied with or there is doubt as to whether wild game meat is fit for consumption, carry out any veterinary checks he or it deems appropriate. 2. Member States shall take administrative and/or penal measures to penalize any infringement of Community veterinary legislation, in particular where it is found that the certificates or documents drawn up do not correspond to the actual state of the wild game meat, that identification marks do not comply with the rules, that the wild game meat was not presented for inspection or that such meat was not used for the purpose originally intended. Article 14 1. The rules laid down in Council Directive 89/662/EEC concerning veterinary checks to be carried out in intra-Community trade with a view to the completion of the internal market shall apply in particular to the organization of and the action to be taken following the checks carried out by the country of destination and to the safeguard measures to be applied in relation to health problems affecting the production and distribution of wild game meat in the territory of the Community. 2. Directive 89/662/EEC shall be amended as follows: (a) in Annex A, the following indent shall be aded: '- Council Directive 92/45/EEC of 16 June 1992 on public health and animal health problems relating to the killing of wild game and the placing on the market of wild game meat (OJ No L 268, 14. 9. 1992, p. 35).'; (b) in Annex B, the indent '- wild game meat' shall be deleted. 3. In Article 2 (d) of Directive 77/99/EEC, the following indent shall be added: '- Article 2 (1) (d) of Council Directive 92/45/EEC (13)() and meeting the requirements of Articles 3 and 5, (14)() OJ No L 268, 14. 9. 1992, p. 35.' CHAPTER III Provisions applicable to imports into the Community Article 15 The conditions applicable to the placing on the market of wild game meat imported from third countries shall be at least equivalent to those laid down for the production and placing on the market of wild game meat obtained in accordance with Chapter II, excluding those in Articles 6 and 8. Article 16 1. For the purpose of uniform application of Article 15, the provisions of the following paragraphs shall apply. 2. In order to be imported into the Community, wild game or wild game meat must: (a) come from third countries or parts of third countries from which imports are not prohibited on animal health grounds; (b) come from a third country on the list to be drawn up in accordance with paragraph 3 (a); (c) be accompanied by a health certificate corresponding to a specimen to be drawn up in accordance with the procedure laid down in Article 22, signed by the competent authority and certifying that the products meet the requirements of Chapter II or any additional conditions or offer the equivalent guarantees referred to in paragraph 3 (c) and come from establishments offering the guarantees provided for in Annex I. 3. The following shall be established in accordance with the procedure laid down in Article 22: (a) a provisional list of third countries or parts of third countries able to provide Member States and the Commission with the conditions and guarantees referred to in paragraph 2 (c) and a list of establishments for which they are able to give these guarantees. This provisional list shall be compiled from the lists of establishments approved and inspected by the competent authorities of the Member States, once the Commission has checked that they abide by the principles and general rules laid down in this Directive; (b) updates of that list in the light of the checks provided for in paragraph 4; (c) the specific conditions and the equivalent guarantees relating to the requirements of this Directive, other than those enabling meat to be excluded from human comsumption in accordance with Article 3 (2) (d) and those of Article 5 and those laid down in Annex I, Chapters IV and V, and, as regards the trichinoscopic examination by the digestion method, in accordance with Directive 77/96/EEC, on the understanding that such conditions and guarantees may not be less stringent than those laid down in Chapter II, excluding those in Articles 6 and 8. 4. Experts from the Commission and the Member States shall carry out on-the-spot inspections to verify whether: (a) the guarantees given by the third country regarding the conditions of production and placing on the market can be considered equivalent to those applied in the Community; (b) the conditions of Article 18 are fulfilled. The experts from the Member States responsible for these inspections shall be appointed by the Commission acting on a proposal from the Member States. These inspections shall be made on behalf of the Community, which shall bear the cost of any expenditure in this connection. The frequency of and procedure for these inspections shall be determined in accordance with the procedure laid down in Article 22. 5. Pending the organization of the inspections referred to in paragraph 4, national rules applicable to inspection in third countries shall continue to apply, subject to notification, through the Standing Veterinary Committee, of any failure to comply with hygiene rules found during these inspections. Article 17 1. Member States shall ensure that wild game or wild game meat covered by this Directive is imported into the Community only if it: - is accompanied by the certificate provided for in Article 16 (1) (c), covering public and animal health requirements issued by the competent authority at the time of loading, - has satisfied the checks required by Directive 90/675/EEC. 2. Pending the establishment of detailed rules for implementing this Article: - the national rules applicable to imports from third countries for which such requirements have not been adopted at Community level shall continue to apply, provided they are not more favourable than those laid down in Chapter II, - imports must take place under the conditions laid down in Article 11 of Directive 90/675/EEC, - trade in wild game or wild game meat imported in accordance with this paragraph must be subject to the prior agreement of the country of destination. Article 18 The lists provided for in Article 16 (2) may include only third countries or parts of third countries: (a) from which imports are not prohibited as a result of the existence of one of the diseases referred to in Annex A to the OIE list, or of any other disease exotic to the Community, or pursuant to Articles 6, 7 and 14 of Directive 72/462/EEC (¹), or Articles 9 to 12 of Directive 91/494/EEC; (b) which, in view of their legislation and the organization of their veterinary services and of their inspection services, the powers of such services and the supervision to which they are subject, have been recognized, in accordance with Article 3 (2) of Directive 72/462/EEC or Article 9 (2) of Directive 91/494/EEC, as capable of guaranteeing the implementation of their legislation in force; or (¹) Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat from third countries (OJ No L 302, 31. 12. 1972, p. 28). Last amended by Directive 91/497/EEC (OJ No L 268, 24. 9. 1991, p. 69). (c) the veterinary services of which are able to guarantee that health requirements at least equivalent to those laid down in Chapter II are being complied with. Article 19 1. The principles and rules laid down in Directive 90/675/EEC shall apply, with particular reference to the organization of and follow-up to the inspections to be carried out by the Member States and the safeguard measures to be implemented. Pending implementation of the decisions provided for in Article 8 (3) and Article 30 of Directive 90/675/EEC, the relevant national rules for applying Article 8 (1) and (2) of that Directive shall continue to apply, without prejudice to compliance with the principles and rules referred to in the first subparagraph of this Article. CHAPTER IV Final provisions Article 20 This Directive shall not affect Community rules adopted for the conservation of wildlife. Article 21 The Annexes shall be amended by the Council acting by a qualified majority on a proposal from the Commission in particular to adapt them to advances in technology. Article 22 1. Where the procedure laid down in this Article is to be followed, matters shall without delay be referred to the Standing Veterinary Committee (hereinafter called 'the Committee') set up by Decision 68/361/EEC (¹) by its Chairman, either on his own initiative or at the request 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 deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote. 3. (a) The Commission shall adopt the measures envisaged and implement them immediately if they are in accordance with the opinion of the Committee. (b) If 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 relating to the measures to be taken. The Council shall act by a qualified majority. If, within three months from the date of referral to the Council, the Council has not acted, the Commission shall adopt the proposed measures save where the Council has rejected the said measures by a simple majority. Article 23 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1994. 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 test of the main provisions of national law which they adopt in the field governed by this Directive. 3. The setting of the deadline for transposition into national law at 1 January 1994 shall be without prejudice to the abolition of veterinary checks at frontiers provided for in Directive 89/662/EEC. Article 24 This Directive is addressed to the Member States.

31992L0048

1992

Council Directive 92/48/EEC of 16 June 1992 laying down the minimum hygiene rules applicable to fishery products caught on board certain vessels in accordance with Article 3 (1) (a) (i) of Directive 91/493/EEC Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 91/493/EEC of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products (1), and in particular Article 3 (1) (a) (i) thereof, Having regard to the proposal from the Commission, Whereas in accordance with Article 3 (1) (a) (i) of Directive 91/493/EEC it is essential that hygiene rules be laid down for fishery products caught and where appropriate handled for bleeding, heading, gutting and the removal of fins, chilled or frozen, on board certain vessels; Whereas general hygiene conditions applicable to fishing vessels should be laid down; Whereas it is important to lay down additional hygiene conditions applicable to fishing vessels on board which catches are kept for more than twenty-four hours; Whereas provisions should be made for the possibility of taking into consideration certain specific characteristics of certain fishing vessels; Whereas it is appropriate to point out that the inspections and controls carried out pursuant to Directive 91/493/EEC apply equally to the vessels referred to in this Directive, Article 1 1. The general hygiene conditions laid down in Annex I shall apply to fishery products handled on board fishing vessels. 2. The additional hygiene conditions laid down in Annex II shall apply to fishing vessels designed and equipped to preserve fishery products on board under satisfactory conditions for more than twenty-four hours, other than those equipped for keeping fish, shellfish and molluscs alive without other means of conservation on board. 3. If necessary, and in accordance with the procedure laid down in Article 2, derogations from or conditions additional to the provisions of Annex I may be laid down in order to take account of the specific characteristics, if any, of certain fishing vessels. Article 2 The Annexes to this Directive may be amended in accordance with the procedure laid down in Article 15 of Directive 91/493/EEC. Article 3 Member States may, provided that the products coming from fishing vessels expressly comply with the hygiene standards set by Directive 91/493/EEC, grant a further period to fishing vessels, expiring on 31 December 1995, within which to comply with the said requirements laid down in points 8 (b) and (e) of Annex II. Such derogations may only be obtained by fishing vessels which, carrying out fishing activities on 30 June 1992, have submitted to the competent national authorities, before 31 December 1992, a duly justified application to that effect. This application must set out details of the periods within which the fishing vessels can comply with the said requirements. In the event that financial aid is solicited from the Community, only those projects that comply with the requirements of this Directive may be accepted. Article 4 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1993. They shall inform the Commissin 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. Article 5 This Directive is addressed to the Member States.

31992L0052

1992

COUNCIL DIRECTIVE 92/52/EEC of 18 June 1992 on infant formulae and follow-on formulae intended for export to third countries Having regard to the Treaty establishing the European Economic Community, and in particular Article 113 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 Community rules concerning infant formulae and follow-on formulae are laid down by Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs for particular nutritional uses (4) in Commission Directive 91/321/EEC (5); Whereas given the nature of the products in question it is desirable that Community rules or international standards relating to their composition are made applicable to such products intended for export to third countries; Whereas in order to prevent inappropriate use of these products which could prejudice the health of infants it is also desirable to extend the application of the Community rules on labelling of infant formulae and follow-on formuale to those products intended for export to third countries; Whereas the products complying with Directive 91/321/EEC may be marketed in the Community as from 1 December 1992; whereas no legislation prohibits the export of such products to third countries, Article 1 This Directive concerns infant formuale and follow-on formulae, as defined by Article 1 (2) (c) and (d) of Directive 91/321/EEC, intended for export to third countries. Article 2 Member States shall ensure that the products referred to in Article 1 may be exported from the Community only if they comply with this Directive. Article 3 1. No product other than infant formulae may be represented as suitable for satisfying by itself the nutritional requirements of normal healthy infants during the first four to six months of life. 2. In addition the products referred to in Article 1 must comply: (a) with Articles 3, 4, 5 and 6 of Directive 91/321/EEC or with relevant applicable world standards established by Codex Alimentarius; (b) with Article 7 (2) to (6) of Directive 91/321/EEC; (c) with the provisions of Council Directive 89/396/EEC of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs (6), unless otherwise requested or stipulated by provisions established by the importing country. 3. These products shall be labelled in an appropriate language and in such a way as to avoid any risk of confusion between infant formulae and follow-on formulae. 4. The stipulations, prohibitions and restrictions laid down in Article 7 (2) to (6) of Directive 91/321/EEC shall also apply to the presentation of the products concerned and in particular their form, aspect or packaging and the packaging materials used. Article 4 Member States shall take the necessary measures to comply with this Directive. They shall forthwith inform the Commission thereof. Those measures shall be applied in such a way as to prohibit exports of products which do not comply with this Directive, with effect from 1 June 1994. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 5 This Directive is addressed to the Member States.

31992L0053

1992

Council Directive No 92/53/EEC of 18 June 1992 amending Directive 70/156/EEC on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers 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 it is important to adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market shall comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas Directive 70/156/EEC (4) laid down the Community type-approval procedure for vehicles, components and separate technical units built in compliance with the technical requirements set out in separate Directives and also the complete list of vehicle systems, components and separate technical units covered by these Directives; Whereas in the interest of the establishment and operation of the internal market of the Community it appears appropriate to replace the existing type-approval systems of the Member States by the Community type-approval procedure; Whereas, in order that the said type-approval procedure may achieve its objective in the most effective manner it appears necessary to make its administrative provisions more precise and comprehensive; whereas this implies, inter alia, that these provisions allow for the type-approval of a whole vehicle to be established by compilation of approvals of its constituent systems, components and separate technical units, if the manufacturer so desires, and in the case of vehicles built in several stages involving several manufacturers, by compilation of the approvals of the different stages of completion; Whereas a vehicle may comply with the provisions of this Directive but nevertheless have certain features which demonstrably present a potential risk for road safety; whereas it is therefore desirable to allow the Member States to refuse to approve such vehicle types as well as to prohibit the sale and entry into service and refuse registration of the said vehicles; whereas for the latter case appropriate conditions are established; Whereas the mandatory nature of the Community type-approval procedure makes it necessary to allow for exemptions and lay down alternative procedures for vehicles either designed for special purposes or built in small series or incorporating new technologies not yet covered by the provisions of the separate Directives; Whereas in order to facilitate the access to the markets of countries outside the Community it appears appropriate to allow, under certain conditions, for the acceptance of system, component and separate technical unit approvals based on equivalent international and third-country regulations; whereas equivalence of such regulations is to be established in application of the relevant provisions of the Treaty; Whereas in order to ensure the necessary transparancy of the Community type-approval procedures it is necessary to lay down provisions according to which the Member States shall notify each other and the Commission of their approval authorities and technical services as well as provisions on the quality criteria with which the latter have to comply; Whereas since the Annexes to the present Directive are complete only for vehicles of category M1, the Directive applies only to the type-approval of such vehicles; whereas it appears advisable that pending the completion of the Annexes by provisions relating to vehicles of all other categories, Member States should be allowed to continue to operate their national approval systems in relation to such vehicles in accordance with Article 10 of Directive 70/156/EEC; Whereas, in order to allow for an adequate transition, both from the technical and administrative points of view, from the present optional regime of Community requirements to the mandatory type-approval procedure established by the present Directive, it appears appropriate to leave the manufacturers the option between the application of the procedure of the present Directive and that provided for in Article 10 of Directive 70/156/EEC for a period of three years; whereas approvals granted in application of the latter procedure should remain valid until 31 December 1997; Whereas the aforementioned transitional provisions are not intended to allow the Member States to derogate from the provisions of separate Directives which are based on total harmonization, Article 1 Directive 70/156/EEC is hereby amended as follows: 1. Articles 1 to 16 are replaced by the following Articles: 'Article 1 Scope This Directive applies to the type-approval of motor vehicles and their trailers built in one or more stages, of systems, components and separate technical units intended for use on such vehicles and trailers. It does not apply to: - the approval of single vehicles except that Member States granting such approvals shall accept any valid system, component, separate technical unit or incomplete vehicle approval granted under this Directive instead of the relevant national requirement, - 'quadricycles' whithin the meaning of Article 1 (3) of Council Directive 92/61/EEC relating to the type-approval of two- oder three-wheel motor vehicles (5)(). (6)() OJ No 225, 10. 8. 1992, p. 72. Article 2 Definitions For the purpose of this Directive: - type-approval means the procedure whereby a Member State certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant technical requirements of this Directive or a separate Directive contained in the exhaustive list set out in Annex IV or XI, - multi-stage type-approval means the procedure whereby one or more Member States certify that, depending on the state of completion, an incomplete or completed vehicle type satisfies the relevant technical requirements of this Directive, - vehicle means any motor vehicle intended for use on the road, being complete or incomplete, having at least four wheels and a maximum design speed exceeding 25 km/h, and its trailers, with the exception of vehicles which run on rails and of agricultural and forestry tractors and all mobile machinery, - base vehicle means any incomplete vehicle, the vehicle identification number of which is retained during subsequent stages of the multi-stage type-approval process, - incomplete vehicle means any vehicle which still needs completion in at least one further stage in order to meet all the relevant requirements of this Directive, - completed vehicle means a vehicle resulting from the process of multi-stage type-approval which meets all the relevant requirements of this Directive, - type of vehicle means vehicles of one category which do not differ in at least the essential respects specified in Annex II.B. A type of vehicle may contain variants and versions (see Annex II.B), - system means any vehicle system such as brakes, emission control equipment, interior fittings, etc. which is subject to the requirements in any of the separate Directives, - component means a device, such as a lamp, subject to the requirements of a separate Directive, intended to be part of a vehicle, which may be type-approved independently of a vehicle where the separate Directive makes express provisions for so doing, - separate technical unit means a device, such as a rear protective device, subject to the requirements of a separate Directive, intended to be part of a vehicle, which may be type-approved separately but only in relation to one or more specified types of vehicle, where the separate Directive makes express provisions for so doing, - manufacturer means the person or body who is responsible to the approval authority for all aspects of the type-approval process and for ensuring conformity of production. It is not essential that the person or body is directly involved in all stages of the construction of the vehicle, system, component or separate technical unit which is the subject of the approval process, - approval authority means the competent authority of a Member State which is responsible for all aspects of type-approval of a type of vehicle, system, component or separate technical unit, to issue and (if appropriate) to withdraw approval certificates, to serve as the contact point with the approval authorities of the other Member States and which is responsible for verifying the manufacturer's conformity of production arrangements, - technical service means the organization or body that has been appointed as a testing laboratory to carry out tests or inspections on behalf of the approval authority of a Member State. This function may also be carried out by the approval authority itself, - information document means the document set out in Annex I or Annex III to this Directive or the corresponding Annex to a separate Directive that prescribes the information to be supplied by an applicant, - information folder means the total folder or file of data, drawings, photographs, etc. supplied by the applicant to the technical service or the approval authority as prescribed in the information document, - information package means the information folder plus any test reports or other documents that the technical service or the approval authority has added to the information folder in the course of carrying out their functions. - index to the information package means the document in which is listed the contents of the information package suitably numbered or otherwise marked to clearly identify all pages. Article 3 Application for type-approval 1. Applications for vehicle type-approval shall be submitted by the manufacturer to the approval authority of a Member State. An application shall be accompanied by an information folder containing the information required by Annex III, and by the approval certificates for each of the applicable separate Directives as required by Annex IV or XI; also, the information package in respect of each separate Directive shall be made available to the approval authority throughout the period up to the date when the approval is either issued or refused. 2. By way of derogation from paragraph 1, in the case where no approval certificates for any of the relevant separate Directives are available, the documents accompanying an application shall comprise an information folder containing the relevant information required by Annex I in relation to the separate Directives specified in Annex IV or XI and, where applicable, Part II of Annex III. 3. In the case of multi-stage type-approval the information to be supplied shall consist of: - at stage 1: those parts of the information folder and the approval certificates as required for a complete vehicle which are relevant to the state of completion of the base vehicle, - at the second and subsequent stages: those parts of the information folder and the approval certificates which are relevant to the current stage of construction and a copy of the approval certificate for the incomplete vehicle issued at the previous stage of build. In addition, the manufacturer shall supply full details of the changes and additions carried out by him to the incomplete vehicle. 4. Applications for system component or separate technical unit type-approval shall be submitted by the manufacturer to the approval authority of a Member State. An application shall be accompanied by an information folder, the contents of which is given in the information document in the relevant separate Directive. 5. No application in respect of one type of vehicle, system, component or separate technical unit may be submitted to more than one Member State. A separate application shall be submitted for each type to be approved. Article 4 The type-approval process 1. Each Member State shall grant: (a) vehicle type-approval to: - vehicle types which conform to the particulars in the information folder and which meet the technical requirements of all the relevant separate Directives as prescribed in Annex IV, - special-purpose vehicle types mentioned in Annex XI which conform to the particulars in the information folder and which meet the technical requirements of the separate Directives as denoted in the relevant column of Annex XI. This process shall be satisfied by the procedures described in Annex V; (b) multi-stage type-approval to base, incomplete or completed vehicle types which conform to the particulars in the information folder and which meet the technical requirements of the relevant separate Directives as prescribed in Annex IV or XI taking account of the state of completion of the vehicle type. This process shall be satisfied by the procedures described in Annex XIV; (c) system type-approval to vehicle types which conform to the particulars in the information folder and which meet the technical requirements of a relevant separate Directive; (d) component or separate technical unit type-approval to all types of component or separate technical unit which conform to the particulars in the information folder and which meet the technical requirements contained in the relevant separate Directive which makes express provision for so doing. 2. However, if a Member State finds that a vehicle, system, component or separate technical unit which complies with the provisions of paragraph 1 is nevertheless, a serious risk to road safety, it may refuse to grant the type-approval. It shall forthwith inform the other Member States and the Commission thereof, stating the reasons on which its decision is based. 3. Each Member State shall complete all applicable sections of a type-approval certificate (models for which are given in Annex VI to this Directive and in an Annex to each of the separate Directives) for each type of vehicle, system, component or separate technical unit which it approves and, in addition, shall complete the relevant sections of the test results attachment to the vehicle approval certificate (the model for which is given in Annex VIII) and shall compile or verify the contents of the index to the information package. Approval certificates shall be numbered in accordance with the method described in Annex VII. The completed certificate and its attachments shall be delivered to the applicant. 4. Where the component or the separate technical unit to be approved fulfils its function or offers a specific feature only in conjunction with other parts of the vehicle and for this reason compliance with one or more requirements can be verified only when the component or separate technical unit to be approved operates in conjunction with other vehicle parts, whether real or simulated, the scope of the type-approval of the component or the separate technical unit must be restricted accordingly. The type-approval certificate for a component or a separate technical unit shall then include any restrictions on its use and shall indicate any conditions for fitting it. Observance of these restrictions and conditions shall be verified at the time of type-approval of the vehicle. 5. The approval authority of each Member State shall, within one month, send to the approval authorities of the other Member States a copy of the vehicle type-approval certificate (together with its attachments) for each vehicle type which it has approved or refused to approve or withdrawn. 6. The approval authority of each Member State shall send monthly to the approval authorities of the Member States a list (containing the particulars shown in Annex XIII) of the system, component or separate technical unit approvals it has granted, refused to grant or withdrawn during that month; in addition, on receiving an application from the approval authority of another Member State, it shall send forthwith a copy of the system, component or separate technical unit type-approval certificate and/or information package for each type of system, component or separate technical unit which it has approved or refused to approve or withdrawn. Article 5 Amendments to approvals 1. The Member State which has granted type-approval must take the necessary measures to ensure that it is informed of any change in the particulars appearing in the information package. 2. The application for the amendment or extension of a type-approval shall be submitted exclusively to the Member State which granted the original type-approval. 3. In the case of system, component or separate technical unit approval, if particulars appearing in the information package have changed, the approval authority of the Member State in question shall: - issue revised page(s) of the information package as necessary, marking each revised page to show clearly the nature of the change and the date of re-issue. On any occasion when revised pages are issued the index to the information package (which is attached to the approval certificate) shall also be amended to show the latest dates of revised pages, and - issue a revised approval certificate (denoted by an extension number) if any information on it (excluding its attachments) has changed or if the requirements of the Directive have changed since the date currently on the approval. The revised certificate shall show clearly the reason for revision and the date of re-issue. If the approval authorities of the Member State in question find that an amendment to an information package warrants fresh tests or checks it shall inform the manufacturer thereof and issue the documents mentioned above only after the conduct of successful fresh tests or checks. 4. In the case of vehicle approval, if particulars appearing in the information package have changed, the approval authority of the Member State in question shall: - issue revised page(s) of the information package as necessary, marking each revised page to show clearly the nature of the change and the date of re-issue. On any occasion when revised pages are issued the index to the information package (which is attached to the approval certificate) shall also be amended to show the latest dates of revised pages, and - issue a revised approval certificate (denoted by an extension number) if either further inspections are required or any information on the approval certificate (excluding its attachments) has changed or if the requirements of any of the separate Directives applicable to the date from which first entry into service is prohibited have changed since the date currently on the vehicle approval. The new certificate shall show clearly the reason for extension and the date of re-issue. If the approval authority of the Member State in question finds that an amendment to an information package warrants fresh inspections it shall inform the manufacturer thereof and issue the documents mentioned above only after the conduct af successful fresh inspections. Any revised documents shall be sent to all other approval authorities within one month. 5. Where a vehicle type-approval is no longer valid because one or more of the separate Directive approvals referred to in its information package is no longer valid the approval authority of the Member State which granted that approval shall, within one month, communicate that fact to the approval authorities of the other Member States together with an indication of the relevant date or the vehicle identification number of the last vehicle produced in conformity with the old certificate. Article 6 Certificate of conformity 1. The manufacturer, in his capacity as the holder of a vehicle type-approval, shall issue a certificate of conformity (models for which are given in Annex IX), which shall accompany each vehicle, whether complete or incomplete, manufactured in conformity with the approved vehicle type. In the case of an incomplete or completed vehicle type, the manufacturer shall complete only those items on side 2 of the certificate of conformity which have been added or changed at the current stage of approval and, if applicable, shall attach to this certificate all certificates of conformity delivered at the previous stage(s). 2. However, Member States may, for purposes of vehicle taxation or registration, after giving at least three months' notice to the Commission and the other Member States, request particulars not mentioned in Annex IX to be added to the certificate provided that such particulars are explicitly stated in the information package or can be derived from it by a simple calculation. Member States may also request that the certificate of conformity contained in Annex IX be completed in such a way as to highlight the data necessary and sufficient for the purposes of taxation and registration by the national competent authorities. 3. The manufacturer, in his capacity as the holder of a type-approval for a component or separate technical unit shall affix to each component or unit manufactured in conformity with the approved type the trade name or mark, the type and/or, if the separate Directive so provides, the type-approval mark or number. However, in the latter case, the manufacturer may choose not to affix the trade name or mark and type. 4. The manufacturer, in his capacity as the holder of a type-approval certificate, which in accordance with the provisions of Article 4 (4) includes restrictions on its use, shall deliver with each component or unit manufactured detailed information on these restrictions and shall indicate any conditions for fitting it. Article 7 Registration and entry into service 1. Each Member State shall register, permit the sale or entry into service of new vehicles on grounds relating to their construction and functioning if, and only if, they are accompanied by a valid certificate of conformity. In the case of incomplete vehicles, each Member State shall permit the sale of such vehicles but may refuse their permanent registration and entry into service so long as they are not completed. 2. Each Member State shall permit the sale or entry into service of components or separate technical units if, and only if, they comply with the requirement of the relevant separate Directive and the requirements referred to in Article 6 (3) provided that this shall not apply to components and separate technical units intended for use on vehicles which are fully or partially exempt from or not covered by this Directive. 3. If a Member State finds that vehicles, components or separate technical units of a particular type are a serious risk to road safety although they are accompanied by a valid certificate of conformity or are properly marked, then that State may, for a maximum period of six months, refuse to register such vehicles or may prohibit the sale or entry into service in its territory of such vehicles, components or separate technical units. It shall forthwith notify the other Member States and the Commission thereof, stating the reasons on which its decision is based. If the Member State which granted type-approval disputes the risk to road safety notified to it the Member States concerned shall endeavour to settle the dispute. The Commission shall be kept informed and shall, where necessary, hold appropriate consultations for the purpose of reaching a settlement. Article 8 Exemptions and alternative procedures 1. The requirements of Article 7 (1) do not apply to: - vehicles intended for use by the armed services, civil defence, fire services and forces responsible for maintaining public order, - vehicles approved in accordance with paragraph 2. 2. Each Member State may, at the request of the manufacturer, exempt from one or more of the provisions of one or more of the separate Directives: (a) Vehicles produced in small series In this case, the number of vehicles of a family of types per year registered, sold or entering service in that Member State shall be limited to not more than the number of units shown in Annex XII. Each year the Member States shall send to the Commission a list of such approvals. The Member State granting such an approval shall send a copy of the approval certificate and its attachments to the approval authorities of the other Member States designated by the manufacturer, stating the nature of exemptions which have been granted. Within three months these Member States shall decide whether, and for which number of units, they accept the type-approval for vehicles to be registered within their territory. For the purposes of approvals granted in accordance with this point (a), the requirements of Articles 3, 4, 5, 6, 10 and 11 shall apply only in so far as they are deemed to be relevant by the approval authority. Where an exemption is granted in accordance with this point (a) the Member State may require a relevant alternative provision; (b) End-of-series vehicles 1. Within the quantitative limits contained in Annex XII, section B and for a limited period Member States may register and permit the sale or entry into service of new vehicles conforming to a type of vehicle whose type-approval is no longer valid under Article 5 (5). This provision shall apply only to vehicles which: - were in the territory of the European Community, and - were accompanied by a valid certificate of conformity which had been issued when the type-approval of the vehicle in question was still valid, but which had not been registered or put into service before the said type-approval lost its validity. This option shall be limited to a period of 12 months for complete vehicles and 18 months for vehicles completed as from the date on which the type-approval lost its validity. 2. For paragraph 1 to be applied to one or more vehicle types of a given category, the manufacturer must submit a request to the competent authorities of the Member State which approved the corresponding type(s) of vehicle before the entry into force of the separate Directives or of the amendments thereto. The request must specify the technical and/or economic reasons on which it is based. If the request is accepted by the Member State, the latter must, within a month, send the competent authorities of the other Member States particulars of and reasons for the exemptions granted to the manufacturer together with the information provided for in Article 5 (5). Each Member State concerned by the entry into service of such types of vehicle shall be responsible for ensuring that the manufacturer complies with the provisions of Annex XII B. Member States shall each year send the Commission a list of exemptions granted and the reasons therefor. (c) Vehicles, components or separate technical units incorporating technologies or concepts which cannot, due to their specific nature, comply with one or more of the requirements of one or more of the separate Directives In this case, the Member State granting such an approval shall, within one month, send a copy of the approval certificate and its attachments to the approval authorities of the other Member States and shall forthwith send to the Commission a report containing: - the reason why the technologies or concepts in question prevent the vehicle, component or separate technical unit from complying with the requirements of one or more of the relevant separate Directives, - a description of the areas of safety and environmental protection concerned and the measures taken, - a description of the tests and their results that demonstrate at least an equivalent level of safety and environmental protection as is provided by the requirements of one or more of the relevant separate Directives. - proposals for amendments to the relevant separate Directives or new separate Directive(s) as applicable. The Commission shall, in accordance with the procedure laid down in Article 13, decide within three months whether or not to approve the report. If the Commission approves the report, the Member State may issue a type-approval in accordance with this Directive and the Commission will take the necessary steps to adapt the separate Directive(s) to which the derogation was granted. The validity of such type-approval is restricted to 24 months, but may be extended by the Commission upon request of the Member State which has granted the type-approval. 3. Approval certificates issued in accordance with paragraph 2, the models for which are shown in Annex VI, may not carry the heading 'EEC Vehicle Type-Approval Certificate', except in the case mentioned in 2 (c) where the Commission has approved the report. Article 9 Acceptance of equivalent approvals 1. The Council may, acting by a qualified majority on a proposal from the Commission, acknowledge the equivalence between the conditions or provisions for type-approval of systems, components and separate technical units established by the present Directive and the procedures established by international regulations or regulations of third countries, in the framework of multilateral or bilateral agreements between the Community and third countries. 2. The equivalence of the international regulations listed in Part II of Annex IV with the corresponding separate Directives shall be recognized. The approval authorities of the Member States shall accept approvals according to those regulations and, where applicable, the pertaining approval marks, in lieu of the corresponding approvals and/or approvals marks according to the equivalent separate Directives. The listed international regulations shall be published in the Official Journal of the European Communities. Article 10 Conformity of production arrangements 1. A Member State granting type-approval shall take the necessary measures in accordance with Annex X in relation to that approval to verify, if need be in cooperation with the approval authorities of the other Member States, that adequate arrangements have been made to ensure that production vehicles, systems, components or separate technical units, as the case may be, conform to the approved type. 2. A Member State which has granted a type approval shall take the necessary measures in accordance with Annex X in relation to that approval to verify, if need be in cooperation with the approval authorities of the other Member States, that the arrangements referred to in paragraph 1 continue to be adequate and that production vehicles, systems, components or separate technical units, as the case may be, continue to conform to the approved type. Verification to ensure that products conform to the approved type shall be limited to the procedures set out in section 2 of Annex X and in those separate Directives that contain specific requirements. Article 11 Nonconformity with the approved type 1. There shall be failure to conform to the approved type where deviations from the particulars in the type-approval certificate and/or the information package are found to exist und where these deviations have not been authorized under Article 5 (3) or (4), by the Member State which granted the type-approval. A vehicle shall not be considered to deviate from the approved type where tolerances are permitted by separate Directives and these tolerances are respected. 2. If a Member State which has granted type-approval finds that vehicles, components or separate technical units accompanied by a certificate of conformity or bearing an approval mark do not conform to the type it has approved, it shall take the necessary measures to ensure that production vehicles, components or separate technical units, as the case may be, again conform to the approved type. The approval authorities of that Member State shall advise those of the other Member States of the measures taken which may, where necessary, extend to withdrawal of type-approval. 3. If a Member State demonstrates that vehicles, components or separate technical units accompanied by a certificate of conformity or bearing an approval mark do not conform to the approved type it may request the Member State which granted the type-approval to verify that vehicles, components or separate technical units, as the case may be, in production conform to the approved type. Such action shall be taken as soon as possible and in any case within six months of the date of the request. 4. In the case of: - vehicle type-approval where the nonconformity of a vehicle arises exclusively from the nonconformity of a system, component or separate technical unit, or - multi-stage type-approval where the nonconformity of a completed vehicle arises exclusively from the nonconformity of a system, component or separate technical unit being part of the incomplete vehicle, or of the incomplete vehicle itself, the vehicle-approval authority shall request the Member State(s) which granted any relevant system, component, separate technical unit or incomplete vehicle type-approval(s) to take the necessary action to ensure that vehicles in production again conform to the approved type. Such action shall be taken as soon as possible and in any case within six months of the date of the request, if necessary in conjunction with the Member State making the request. Where a failure to conform is established, the approval authorities of the Member State which granted the system, component or separate technical unit type-approval or the approval of the incomplete vehicle shall take the measures set out in paragraph 2. 5. The approval authorities of the Member States shall inform each other within one month of any withdrawal of type-approval and of the reasons for such a measure. 6. If the Member State which granted type-approval disputes the failure to conform notified to it the Member States concerned shall endeavour to settle the dispute. The Commission shall be kept informed and shall, where necessary, hold appropriate consultations for the purpose of reaching a settlement. Article 12 Notification of decisions and remedies available All decisions taken pursuant to the provisions adopted in implementation of this Directive and refusing or withdrawing type-approval, or refusing registration or prohibiting sale, shall state in detail the reasons on which they are based. Any decisions shall be notified to the party concerned who shall, at the same time, be informed of the remedies available to him under the laws in force in the Member States and of the time limits allowed for the exercise of such remedies. Article 13 Adaptation of the Annexes 1. A Committee for Adaptation to 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. 2. All the amendments necessary for adapting: - the Annexes to this Directive, or - the provisions of the separate Directives, save as otherwise provided therein, shall be adopted in accordance with the procedure laid down in paragraph 3. This procedure shall also apply to the introduction of provisions on the type-approval of separate technical units into the separate Directives. 3. The representative of the Commission 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. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Regulation shall be weighted in the manner set out in that Article. The Chairman shall not vote. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. If 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 relating to the measures to be taken. The Council shall act by a qualified majority. 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. 4. Should the Council, acting on a proposal from the Commission, adopt a new separate Directive, it shall on the basis of that same proposal adopt appropriate amendments to the relevant Annexes to this Directive. Article 14 Notification of approval authorities and technical services 1. The Member States shall notify to the Commission and to the other Member States the names and addresses of: - the type-approval authorities and, if applicable, the disciplines for which the authorities are responsible, and - the technical services which they have appointed, specifying for which test procedures each of these services has been appointed. The notified services must satisfy the harmonized standards on the operation of testing laboratories (EN 45001) subject to the following provisos: (i) a manufacturer cannot be accredited as a technical service except where the separate Directives make express provision; (ii) for the purposes of this Directive it is not considered exceptional for a technical service to use outside equipment, subject to the agreement of the approval authority. 2. A notified service shall be presumed to satisfy the harmonized standard but, where appropriate, the Commission may request Member States to provide supporting evidence. Third country services may only be notified as an appointed technical service in the framework of a bilateral or multilateral agreement between the Community and the third country.'; 2. Annexes I to III are replaced by the Annexes to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on or before 31 December 1992. They shall forthwith inform the Commission thereof. They shall apply these provisions from 1 January 1993. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. As far as vehicle type-approval is concerned, Member States shall apply this Directive only for vehicles of category M1 equipped with an internal combustion engine pending an amendment of the Annexes in accordance with Article 13 of Directive 70/156/EEC, as amended by this Directive, in order to include vehicles of category M1 powered by engines other than internal combustion engines and other vehicles categories. In the meantime, the provisions of Article 10 of Directive 70/156/EEC, as amended by Directive 87/403/EEC, shall be applicable to vehicle type-approval of the other vehicle categories. 3. Until 31 December 1995 for complete vehicles and until 31 December 1997 for completed vehicles following multi-stage type-approval, Member States shall apply Article 4 (1) of Directive 70/156/EEC, as amended by this Directive, only at the request of the manufacturer. In the meantime Member States shall grant national type-approval to, and permit registration, sale and entry into service of vehicles, components and separate technical units in accordance with the provisions of Article 10 of Directive 70/156/EEC, as amended by Directive 87/403/EEC. 4. Until 31 December 1997 for complete vehicles and until 31 December 1999 for completed vehicles following multi-stage type-approval, Article 7 (1) and (2) of Directive 70/156/EEC, as amended by this Directive, shall not apply to vehicles, components and separate technical units belonging to a type for which a national type-approval has been granted before 1 January 1996 or 1 January 1998 or to a type which a Member State has registered, permitted the sale or entry into service of before 1 January 1996 or 1 January 1998. Approvals forming part of the national type-approval procedure referred to above which have been granted pursuant to the separate Directives shall remain in force after 31 December 1997 for complete vehicles, and after 31 December 1999 for vehicles completed following multi-stage type-approval, unless one of the conditions laid down in the second subparagraph of Article 5 (3) of Directive 70/156/EEC as amended by this Directive should apply. 5. Subject to Article 8 (2) (a) and (b) of Directive 70/156/EEC as amended by this Directive, paragraphs 3 and 4 shall not permit Member States to derogate from any provisions of a separate Directive which lays down requirements based on total harmonization in respect of the type-approval and initial entry into service of a vehicle, component or separate technical unit. Article 3 Not later than 31 December 1994, on the basis of the relevant information communicated by the competent authorities, the Commission shall draw up a report on the application of the European type-approval procedures, paying particular attention to the derogations in Article 8 of Directive 70/156/EEC as amended by this Directive, and on the impact of the new principle of harmonization in the various Member States and where appropriate shall propose the amendments required to improve the type-approval arrangements, including the adaptation of the separate Directives to the new principle of harmonization, and to facilitate the entry into service of the vehicles in the Member States, which amendments shall be adopted in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC as amended by this Directive. Article 4 This Directive is addressed to the Member States.

31992L0049

1992

Council Directive 92/49/EEC of 18 June 1992 on the coordination of laws, regulations and administrative provisions relating to direct insurance other than life assurance and amending Directives 73/239/EEC and 88/357/EEC (third non-life insurance Directive) Having regard to the Treaty establishing the European Economic Community, and in particular Articles 57 (2) and 66 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) , (1) Whereas it is necessary to complete the internal market in direct insurance other than life assurance from the point of view both of the right of establishment and of the freedom to provide services, to make it easier for insurance undertakings with head offices in the Community to cover risks situated within the Community; (2) Whereas the Second Council Directive of 22 June 1988 on the coordination of laws, regulations and administrative provisions relating to direct insurance other than life assurance and laying down provisions to facilitate the effective exercise of freedom to provide services and amending Directive 72/239/EEC (88/357/EEC)(4) has already contributed substantially to the achievement of the internal market in direct insurance other than life assurance by granting policyholders who, by virtue of their status, their size or the nature of the risks to be insured, do not require special protection in the Member State in which a risk is situated complete freedom to avail themselves of the widest possible insurance market; (3) Whereas Directive 88/357/EEC therefore represents an important stage in the merging of national markets into an integrated market and that stage must be supplemented by other Community instruments with a view to enabling all policyholders, irrespective of their status, their size or the nature of the risks to be insured, to have recourse to any insurer with a head office in the Community who carries on business there, under the right of establishment or the freedom to provide services, while guaranteeing them adequate protection; (4) Whereas this Directive forms part of the body of Community legislation already enacted which includes the First Council Directive of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking up and pursuit of the business of direct insurance other than life assurance (73/239/EEC)(5) and the Council Directive of 19 December 1991 on the annual accounts and consolidated accounts of insurance undertakings (91/674/EEC)(6) ; (5) Whereas the approach adopted consists in bringing about such harmonization as is essential, necessary and sufficient to achieve the mutual recognition of authorizations and prudential control systems, thereby making it possible to grant a single authorization valid throughout the Community and apply the principle of supervision by the home Member State; (6) Whereas, as a result, the taking up and the pursuit of the business of insurance are henceforth to be subject to the grant of a single official authorization issued by the competent authorities of the Member State in which an insurance undertaking has its head office; whereas such authorization enables an undertaking to carry on business throughout the Community, under the right of establishment or the freedom to provide services; whereas the Member State of the branch or of the provision of services may no longer require insurance undertakings which wish to carry on insurance business there and which have already been authorized in their home Member State to seek fresh authorization; whereas Directives 73/239/EEC and 88/357/EEC should therefore be amended along those lines; (7) Whereas the competent authorities of home Member States will henceforth be responsible for monitoring the financial health of insurance undertakings, including their state of solvency, the establishment of adequate technical provisions and the covering of those provisions by matching assets; (8) Whereas certain provisions of this Directive define minimum standards; whereas a home Member State may lay down stricter rules for insurance undertakings authorized by its own competent authorities; (9) Whereas the competent authorities of the Member States must have at their disposal such means of supervision as are necessary to ensure the orderly pursuit of business by insurance undertakings throughout the Community whether carried on under the right of establishment or the freedom to provide services; whereas, in particular, they must be able to introduce appropriate safeguards or impose sanctions aimed at preventing irregularities and infringements of the provisions on insurance supervision; (10) Whereas the internal market comprises an area without internal frontiers and involves access to all insurance business other than life assurance throughout the Community and, hence, the possibility for any duly authorized insurer to cover any of the risks referred to in the Annex to Directive 73/239/EEC; whereas, to that end, the monopoly enjoyed by certain bodies in certain Member States in respect of the coverage of certain risks must be abolished; (11) Whereas the provisions on transfers of portfolios must be adapted to bring them into line with the single authorization system introduced by this Directive; (12) Whereas Directive 91/674/EEC has already effected the necessary harmonization of the Member States' rules on the technical provisions which insurers are required to establish to cover their commitments, and that harmonization makes it possible to grant mutual recognition of those provisions; (13) Whereas the rules governing the spread, localization and matching of the assets used to cover technical provisions must be coordinated in order to facilitate the mutual recognition of Member States' rules; whereas that coordination must take account of the measures on the liberalization of capital movements provided for in the Council Directive of 24 June 1988 for the implementation of Article 67 of the Treaty (88/361/EEC)(7) and the progress made by the Community towards economic and monetary union; (14) Whereas, however, the home Member State may not require insurance undertakings to invest the assets covering their technical provisions in particular categories of assets, as such a requirement would be incompatible with the measures on the liberalization of capital movements provided for in Directive 88/361/EEC; (15) Whereas, pending the adoption of a Directive on investment services harmonizing inter alia the definition of the concept of regulated market, for the purposes of this Directive and without prejudice to such future harmonization that concept must be defined provisionally; whereas that definition will be replaced by that harmonized at Community level which will give the home Member State of the market the responsibilities for these matters which this Directive transitionally gives to the insurance undertaking's home Member State; (16) Whereas the list of items of which the solvency margin required by Directive 73/239/EEC may be made up must be supplemented to take account of new financial instruments and of the facilities granted to other financial institutions for the constitution of their own funds; (17) Whereas within the framework of an integrated insurance market policyholders who, by virtue of their status, their size or the nature of the risks to be insured, do not require special protection in the Member State in which a risk is situated should be granted complete freedom to choose the law applicable to their insurance contracts; (18) Whereas the harmonization of insurance contract law is not a prior condition for the achievement of the internal market in insurance; whereas, therefore, the opportunity afforded to the Member States of imposing the application of their law to insurance contracts covering risks situated within their territories is likely to provide adequate safeguards for policyholders who require special protection; (19) Whereas within the framework of an internal market it is in the policyholder's interest that he should have access to the widest possible range of insurance products available in the Community so that he can choose that which is best suited to his needs; whereas it is for the Member State in which the risk is situated to ensure that there is nothing to prevent the marketing within its territory of all the insurance products offered for sale in the Community as long as they do not conflict with the legal provisions protecting the general good in force in the Member State in which the risk is situated, and insofar as the general good is not safeguarded by the rules of the home Member State, provided that such provisions must be applied without discrimination to all undertakings operating in that Member State and be objectively necessary and in proportion to the objective pursued; (20) Whereas the Member States must be able to ensure that the insurance products and contract documents used, under the right of establishment or the freedom to provide services, to cover risks situated within their territories comply with such specific legal provisions protecting the general good as are applicable; whereas the systems of supervision to be employed must meet the requirements of an integrated market but their employment may not constitute a prior condition for carrying on insurance business; whereas from this standpoint systems for the prior approval of policy conditions do not appear to be justified; whereas it is therefore necessary to provide for other systems better suited to the requirements of an internal market which enable every Member State to guarantee policyholders adequate protection; (21) Whereas if a policyholder is a natural person, he should be informed by the insurance undertaking of the law which will apply to the contract and of the arrangements for handling policyholders' complaints concerning contracts; (22) Whereas in some Member States private or voluntary health insurance serves as a partial or complete alternative to health cover provided for by the social security systems; (23) Whereas the nature and social consequences of health insurance contracts justify the competent authorities of the Member State in which a risk is situated in requiring systematic notification of the general and special policy conditions in order to verify that such contracts are a partial or complete alternative to the health cover provided by the social security system; whereas such verification must not be a prior condition for the marketing of the products; whereas the particular nature of health insurance, serving as a partial or complete alternative to the health cover provided by the social security system, distinguishes it from other classes of indemnity insurance and life assurance insofar as it is necessary to ensure that policyholders have effective access to private health cover or health cover taken out on a voluntary basis regardless of their age or risk profile; (24) Whereas to this end some Member States have adopted specific legal provisions; whereas, to protect the general good, it is possible to adopt or maintain such legal provisions in so far as they do not unduly restrict the right of establishment or the freedom to provide services, it being understood that such provisions must apply in an identical manner whatever the home Member State of the undertaking may be; whereas these legal provisions may differ in nature according to the conditions in each Member State; whereas these measures may provide for open enrolment, rating on a uniform basis according to the type of policy and lifetime cover; wheras that objective may also be achieved by requiring undertakings offering private health cover or health cover taken out on a voluntary basis to offer standard policies in line with the cover provided by statutory social security schemes at a premium rate at or below a prescribed maximum and to participate in loss compensation schemes; whereas, as a further possibility, it may be required that the technical basis of private health cover or health cover taken out on a voluntary basis be similar to that of life assurance; (25) Whereas, because of the coordination effected by Directive 73/239/EEC as amended by this Directive, the possibility, afforded to the Federal Republic of Germany under Article 7 (2) (c) of the same Directive, of prohibiting the simultaneous transaction of health insurance and other classes is no longer justified and must therefore be abolished; (26) Whereas Member States may require any insurance undertakings offering compulsory insurance against accidents at work at their own risk within their territories to comply with the specific provisions laid down in their national law on such insurance; whereas, however, this requirement may not apply to the provisions concerning financial supervision, which are the exclusive responsibility of the home Member State; (27) Whereas exercise of the right of establishment requires an undertaking to maintain a permanent presence in the Member State of the branch; whereas responsibility for the specific interests of insured persons and victims in the case of third-party liability motor insurance requires adequate structures in the Member State of the branch for the collection of all the necessary information on compensation claims relating to that risk, with sufficient powers to represent the undertaking vis-à-vis injured parties who could claim compensation, including powers to pay such compensation, and to represent the undertaking or, if necessary, to arrange for it to be represented in the courts and before the competent authorities of that Member State in connection with claims for compensation; (28) Whereas within the framework of the internal market no Member State may continue to prohibit the simultaneous carrying on of insurance business within its territory under the right of establishment and the freedom to provide services; whereas the option granted to Member States in this connection by Directive 88/357/EEC should therefore be abolished; (29) Whereas provision should be made for a system of penalties to be imposed when, in the Member State in which a risk is situated, an insurance undertaking does not comply with those provisions protecting the general good that are applicable to it; (30) Whereas some Member States do not subject insurance transactions to any form of indirect taxation, while the majority apply special taxes and other forms of contribution, including surcharges intended for compensation bodies; whereas the structures and rates of such taxes and contributions vary considerably between the Member States in which they are applied; whereas it is desirable to prevent existing differences' leading to distortions of competition in insurance services between Member States; whereas, pending subsequent harmonization, application of the tax systems and other forms of contribution provided for by the Member States in which risks are situated is likely to remedy that problem and it is for the Member States to make arrangements to ensure that such taxes and contributions are collected; (31) Whereas technical adjustments to the detailed rules laid down in this Directive may be necessary from time to time to take account of the future development of the insurance industry; whereas the Commission will make such adjustments as and when necessary, after consulting the Insurance Committee set up by Directive 91/675/EEC(8) , in the exercise of the implementing powers conferred on it by the Treaty; (32) Whereas it is necessary to adopt specific provisions intended to ensure smooth transition from the legal regime in existence when this Directive becomes applicable to the regime that it introduces, taking care not to place an additional workload on Member States' competent authorities; (33) Whereas under Article 8 c of the Treaty account should be taken of the extent of the effort which must be made by certain economies at different stages of development; whereas, therefore, transitional arrangements should be adopted for the gradual application of this Directive by certain Member States, TITLE I DEFINITIONS AND SCOPE Article 1 For the purposes of this Directive: (a) insurance undertaking shall mean an undertaking which has received official authorization in accordance with Article 6 of Directive 73/239/EEC; (b) branch shall mean an agency or branch of an insurance undertaking, having regard to Article 3 of Directive 88/357/EEC; (c) home Member State shall mean the Member State in which the head office of the insurance undertaking covering a risk is situated; (d) Member State of the branch shall mean the Member State in which the branch covering a risk is situated; (e) Member State of the provision of services shall mean the Member State in which a risk is situated, as defined in Article 2 (d) of Directive 88/357/EEC, if it is covered by an insurance undertaking or a branch situated in another Member State; (f) control shall mean the relationship between a parent undertaking and a subsidiary, as defined in Article 1 of Directive 83/349/EEC(9) , or a similar relationship between any natural or legal person and an undertaking; (g) qualifying holding shall mean a direct or indirect holding in an undertaking which represents 10 % or more of the capital or of the voting rights or which makes it possible to exercise a significant influence over the management of the undertaking in which a holding subsists. For the purposes of this definition, in the context of Articles 8 and 15 and of the other levels of holding referred to in Article 15, the voting rights referred to in Article 7 of Directive 88/627/EEC(10) shall be taken into account; (h) parent undertaking shall mean a parent undertaking as defined in Articles 1 and 2 of Directive 83/349/EEC; (i) subsidiary shall mean a subsidiary undertaking as defined in Articles 1 and 2 of Directive 83/349/EEC; any subsidiary of a subsidiary undertaking shall also be regarded as a subsidiary of the undertaking which is those undertakings' ultimate parent undertaking; (j) regulated market shall mean a financial market regarded by an undertaking's home Member State as a regulated market pending the adoption of a definition in a Directive on investment services and characterized by: - regular operation, and - the fact that regulations issued or approved by the appropriate authorities define the conditions for the operation of the market, the conditions for access to the market and, where the Council Directive of 5 March 1979 coordinating the conditions for the admission of securities to official stock-exchange listing (79/279/EEC)(11) applies, the conditions for admission to listing imposed in that Directive or, where that Directive does not apply, the conditions to be satisfied by a financial instrument in order to be effectively dealt in on the market. For the purposes of this Directive, a regulated market may be situated in a Member State or in a third country. In the latter event, the market must be recognized by the home Member State and meet comparable requirements. Any financial instruments dealt in on that market must be of a quality comparable to that of the instruments dealt in on the regulated market or markets of the Member State in question; (k) competent authorities shall mean the national authorities which are empowered by law or regulation to supervise insurance undertakings. Article 2 1. This Directive shall apply to the types of insurance and undertakings referred to in Article 1 of Directive 73/239/EEC. 2. This Directive shall apply neither to the types of insurance or operations, nor to undertakings or institutions to which Directive 73/239/EEC does not apply, nor to the bodies referred to in Article 4 of that Directive. Article 3 Notwithstanding Article 2 (2), Member States shall take every step to ensure that monopolies in respect of the taking up of the business of certain classes of insurance, granted to bodies established within their territories and referred to in Article 4 of Directive 73/239/EEC, are abolished by 1 July 1994. TITLE II THE TAKING UP OF THE BUSINESS OF INSURANCE Article 4 Article 6 of Directive 73/239/EEC shall be replaced by the following: 'Article 6 The taking up of the business of direct insurance shall be subject to prior official authorization. Such authorization shall be sought from the competent authorities of the home Member State by: (a) any undertaking which establishes its head office within the territory of that State; (b) any undertaking which, having received the authorization referred to in the first subparagraph, extends its business to an entire class or to other classes'. Article 5 Article 7 of Directive 73/239/EEC shall be replaced by the following: 'Article 7 1. Authorization shall be valid for the entire Community. It shall permit an undertaking to carry on business there, under either the right of establishment or the freedom to provide services. 2. Authorization shall be granted for a particular class of insurance. It shall cover the entire class, unless the applicant wishes to cover only some of the risks pertaining to that class, as listed in point A of the Annex. However: (a) Member States may grant authorization for the groups of classes listed in point B of the Annex, attaching to them the appropriate denominations specified therein; (b) authorization granted for one class or a group of classes shall also be valid for the purpose of covering ancillary risks included in another class if the conditions imposed in point C of the Annex are fulfilled'. Article 6 Article 8 of Directive 72/239/EEC shall be replaced by the following: 'Article 8 1. The home Member State shall require every insurance undertaking for which authorization is sought to: (a) adopt one of the following forms: - in the case of the Kingdom of Belgium: "société anonyme/naamloze vennootschap", "société en commandite par actions/commanditaire vennootschap op aandelen", "association d'assurance mutuelle/onderlinge verzekeringsvereniging", "société coopérative/cooeperatieve vennootschap"; - in the case of the Kingdom of Denmark: "aktieselskaber", "gensidige selskaber"; - in the case of the Federal Republic of Germany: "Aktiengesellschaft", "Versicherungsverein auf Gegenseitigkeit", "OEffentlich-rechtliches Wettbewerbsversicherungsunternehmen"; - in the case of the French Republic: "société anonyme", "société d'assurance mutuelle", "institution de prévoyance régie par le code de la sécurité sociale", "institution de prévoyance régie par le code rural" and "mutuelles régies par le code de la mutualité"; - in the case of Ireland: incorporated companies limited by shares or by guarantee or unlimited; - in the case of the Italian Republic: "società per azioni", "società cooperativa", "mutua di assicurazione"; - in the case of the Grand Duchy of Luxembourg: "société anonyme", "société en commandite par actions", "association d'assurances mutuelles", "société coopérative"; - in the case of the Kingdom of the Netherlands: "naamloze vennootschap", "onderlinge waarborgmaatschappij"; - in the case of the United Kingdom: incorporated companies limited by shares or by guarantee or unlimited, societies registered under the Industrial and Provident Societies Acts, societies registered under the Friendly Societies Acts, the association of underwriters known as Lloyd's; - in the case of the Hellenic Republic: "anonymi etairia", "allilasfalistikos synetairismos"; - in the case of the Kingdom of Spain: "sociedad anónima", "sociedad mutua", "sociedad cooperativa"; - in the case of the Portuguese Republic: "sociedade anónima", "mútua de seguros". An insurance undertaking may also adopt the form of a European Company (SE) when that has been established. Furthermore, Member States may, where appropriate, set up undertakings in any public-law form provided that such bodies have as their objects insurance operations under conditions equivalent to those under which private-law undertakings operate; (b) limit its objects to the business of insurance and operations arising directly therefrom, to the exclusion of all other commercial business; (c) submit a scheme of operations in accordance with Article 9; (d) possess the minimum guarantee fund provided for in Article 17 (2); (e) be effectively run by persons of good repute with appropriate professional qualifications or experience. 2. An undertaking seeking authorization to extend its business to other classes or to extend an authorization covering only some of the risks pertaining to one class shall be required to submit a scheme of operations in accordance with Article 9. It shall, furthermore, be required to show proof that it possesses the solvency margin provided for in Article 16 and, if with regard to such other classes Article 17 (2) requires a higher minimum guarantee fund than before, that is possesses that minimum. 3. Nothing in this Directive shall prevent Member States from maintaining in force or introducing laws, regulations or administrative provisions requiring approval of the memorandum and articles of association and communication of any other documents necessary for the normal exercise of supervision. Member States shall not, however, adopt provisions requiring the prior approval or systematic notification of general and special policy conditions, scales of premiums and forms and other printed documents which an undertaking intends to use in its dealings with policyholders. Member States may not retain or introduce prior notification or approval of proposed increases in premium rates except as part of general price-control systems. Nothing in this Directive shall prevent Member States from subjecting undertakings seeking or having obtained authorization for class 18 in point A of the Annex to checks on their direct or indirect resources in staff and equipment, including the qualification of their medical teams and the quality of the equipment available to such undertakings to meet their commitments arising out of this class of insurance. 4. The abovementioned provisions may not require that any application for authorization be considered in the light of the economic requirements of the market'. Article 7 Article 9 of Directive 73/239/EEC shall be replaced by the following: 'Article 9 The scheme of operations referred to in Article 8 (1) (c) shall include particulars or proof concerning: (a) the nature of the risks which the undertaking proposes to cover; (b) the guiding principles as to reinsurance; (c) the items constituting the minimum guarantee fund; (d) estimates of the costs of setting up the administrative services and the organization for securing business; the financial resources intended to meet those costs and, if the risks to be covered are classified in class 18 in point A of the Annex, the resources at the undertaking's disposal for the provision of the assistance promised and, in addition, for the first three financial years: (e) estimates of management expenses other than installation costs, in particular current general expenses and commissions; (f) estimates of premiums or contributions and claims; (g) a forecast balance sheet; (h) estimates of the financial resources intended to cover underwriting liabilities and the solvency margin.' Article 8 The competent authorities of the home Member State shall not grant an undertaking authorization to take up the business of insurance before they have been informed of the identities of the shareholders or members, direct or indirect, whether natural or legal persons, who have qualifying holdings in that undertaking and of the amounts of those holdings. The same authorities shall refuse authorization if, taking into account the need to ensure the sound and prudent management of an insurance undertaking, they are not satisfied as to the qualifications of the shareholders or members. TITLE III HARMONIZATION OF THE CONDITIONS GOVERNING THE BUSINESS OF INSURANCE Chapter 1 Article 9 Article 13 of Directive 73/239/EEC shall be replaced by the following: 'Article 13 1. The financial supervision of an insurance undertaking, including that of the business it carries on either through branches or under the freedom to provide services, shall be the sole responsibility of the home Member State. 2. That financial supervision shall include verification, with respect to the insurance undertaking's entire business, of its state of solvency, of the establishment of technical provisions and of the assets covering them in accordance with the rules laid down or practices followed in the home Member State under provisions adopted at Community level. Where the undertaking in question is authorized to cover the risks classified in class 18 in point A of the Annex, supervision shall extend to monitoring of the technical resources which the undertaking has at its disposal for the purpose of carrying out the assistance operations it has undertaken to perform, where the law of the home Member State provides for the monitoring of such resources. 3. The competent authorities of the home Member State shall require every insurance undertaking to have sound administrative and accounting procedures and adequate internal control mechanisms.' Article 10 Article 14 of Directive 73/239/EEC shall be replaced by the following: 'Article 14 The Member State of the branch shall provide that where an insurance undertaking authorized in another Member State carries on business through a branch the competent authorities of the home Member State may, after having informed the competent authorities of the Member State of the branch, carry out themselves or through the intermediary of persons they appoint for that purpose on-the-spot verification of the information necessary to ensure the financial supervision of the undertaking. The authorities of the Member State of the branch may participate in that verification'. Article 11 Article 19 (2) and (3) of Directive 73/239/EEC shall be replaced by the following: '2. Member States shall require insurance undertakings with head offices within their territories to render periodically the returns, together with statistical documents, which are necessary for the purposes of supervision. The competent authorities shall provide each other with any documents and information that are useful for the purposes of supervision. 3. Every Member State shall take all steps necessary to ensure that the competent authorities have the powers and means necessary for the supervision of the business of insurance undertakings with head offices within their territories, including business carried on outwith those territories, in accordance with the Council Directives governing such business and for the purpose of seeing that they are implemented. These powers and means must, in particular, enable the competent authorities to: (a) make detailed enquiries regarding an undertaking's situation and the whole of its business, inter alia, by: - gathering information or requiring the submission of documents concerning its insurance business, - carrying out on-the-spot investigations at the undertaking's premises; (b) take any measures with regard to an undertaking, its directors or managers or the persons who control it, that are appropriate and necessary to ensure that that undertaking's business continues to comply with the laws, regulations and administrative provisions with which the undertaking must comply in each Member State and in particular with the scheme of operations insofar as it remains mandatory, and to prevent or remedy any irregularities prejudicial to the interests of insured persons; (c) ensure that those measures are carried out, if need be by enforcement and where appropriate through judicial channels. Member States may also make provision for the competent authorities to obtain any information regarding contracts which are held by intermediaries.' Article 12 1. Article 11 (2) to (7) of Directive 88/357/EEC is hereby repealed. 2. Under the conditions laid down by national law, each Member State shall authorize insurance undertakings with head offices within its territory to transfer all or part of their portfolios of contracts, concluded either under the right of establishment or the freedom to provide services, to an accepting office established within the Community, if the competent authorities of the home Member State of the accepting office certify that after taking the transfer into account the latter possesses the necessary solvency margin. 3. Where a branch proposes to transfer all or part of its portfolio of contracts, concluded either under the right of establishment or the freedom to provide services, the Member State of the branch shall be consulted. 4. In the circumstances referred to in paragraphs 2 and 3, the competent authorities of the home Member State of the transferring undertaking shall authorize the transfer after obtaining the agreement of the competent authorities of the Member States in which the risks are situated. 5. The competent authorities of the Member States consulted shall give their opinion or consent to the competent authorities of the home Member State of the transferring insurance undertaking within three months of receiving a request; the absence of any response within that period from the authorities consulted shall be considered equivalent to a favourable opinion or tacit consent. 6. A transfer authorized in accordance with this Article shall be published as laid down by national law in the Member State in which the risk is situated. Such transfers shall automatically be valid against policy-holders, insured persons and any other persons having rights or obligations arising out of the contracts transferred. This provision shall not affect the Member States' rights to give policy-holders the option of cancelling contracts within a fixed period after a transfer. Article 13 1. Article 20 of Directive 73/239/EEC shall be replaced by the following: 'Article 20 1. If an undertaking does not comply with Article 15, the competent authority of its home Member State may prohibit the free disposal of its assets after having communicated its intention to the competent authorities of the Member States in which the risks are situated. 2. For the purposes of restoring the financial situation of an undertaking the solvency margin of which has fallen below the minimum required under Article 16 (3), the competent authority of the home Member State shall require that a plan for the restoration of a sound financial situation be submitted for its approval. In exceptional circumstances, if the competent authority is of the opinion that the financial situation of the undertaking will deteriorate further, it may also restrict or prohibit the free disposal of the undertaking's assets. It shall inform the authorities of other Member States within the territories of which the undertaking carries on business of any measures it has taken and the latter shall, at the request of the former, take the same measures. 3. If the solvency margin falls below the guarantee fund as defined in Article 17, the competent authority of the home Member State shall require the undertaking to submit a short-term finance scheme for its approval. It may also restrict or prohibit the free disposal of the undertaking's assets. It shall inform the authorities of other Member States within the territories of which the undertaking carries on business accordingly and the latter shall, at the request of the former, take the same measures. 4. The competent authorities may further take all measures necessary to safeguard the interests of insured persons in the cases provided for in paragraphs 1, 2 and 3. 5. Each Member State shall take the measures necessary to be able, in accordance with its national law, to prohibit the free disposal of assets located within its territory at the request, in the cases provided for in paragraphs 1, 2 and 3, of the undertaking's home Member State, which shall designate the assets to be covered by such measures.' Article 14 Article 22 of Directive 73/239/EEC shall be replaced by the following: 'Article 22 1. Authorization granted to an insurance undertaking by the competent authority of its home Member State may be withdrawn by that authority if that undertaking: (a) does not make use of that authorization within 12 months, expressly renounces it or ceases to carry on business for more than six months, unless the Member State concerned has made provision for authorization to lapse in such cases; (b) no longer fulfils the conditions for admission; (c) has been unable, within the time allowed, to take the measures specified in the restoration plan or finance scheme referred to in Article 20; (d) fails seriously in its obligation under the regulations to which it is subject. In the event of the withdrawal or lapse of authorization, the competent authority of the home Member State shall notify the competent authorities of the other Member States accordingly, and they shall take appropriate measures to prevent the undertaking from commencing new operations within their territories, under either the right of establishment or the freedom to provide services. The home Member State's competent authority shall, in conjunction with those authorities, take all measures necessary to safeguard the interests of insured persons and, in particular, shall restrict the free disposal of the undertaking's assets in accordance with Article 20 (1), (2), second subparagraph, or (3), second subparagraph. 2. Any decision to withdraw authorization shall be supported by precise reasons and communicated to the undertaking in question.' Article 15 1. Member States shall require any natural or legal person who proposes to acquire, directly or indirectly, a qualifying holding in an insurance undertaking first to inform the competent authorities of the home Member State, indicating the size of his intended holding. Such a person must likewise inform the competent authorities of the home Member State if he proposes to increase his qualifying holding so that the proportion of the voting rights or of the capital he holds would reach or exceed 20, 33 or 50 % or so that the insurance undertaking would become his subsidiary. The competent authorities of the home Member State shall have up to three months from the date of the notification provided for in the first subparagraph to oppose such a plan if, in view of the need to ensure sound and prudent management of the insurance undertaking in question, they are not satisfied as to the qualification of the person referred to in the first subparagraph. If they do not oppose the plan in question, they may fix a maximum period fort its implementation. 2. Member States shall require any natural or legal person who proposes to dispose, directly or indirectly, of a qualifying holding in an insurance undertaking first to inform the competent authorities of the home Member State, indicating the size of his intended holding. Such a person must likewise inform the competent authorities if he proposes to reduce his qualifying holding so that the proportion of the voting rights or of the capital he holds would fall below 20, 33 or 50 % or so that the insurance undertaking would cease to be his subsidiary. 3. On becoming aware of them, insurance undertakings shall inform the competent authorities of their home Member States of any acquisitions or disposals of holdings in their capital that cause holdings to exceed or fall below any of the tresholds referred to in paragraphs 1 and 2. They shall also, at least once a year, inform them of the names of shareholders and members possessing qualifying holdings and the sizes of such holdings as shown, for example, by the information received at annual general meetings of shareholders or members or as a result of compliance with the regulations relating to companies listed on stock exchanges. 4. Member States shall require that, where the influence exercised by the persons referred to in paragraph 1 is likely to operate against the prudent and sound management of an insurance undertaking, the competent authorities of the home Member State shall take appropriate measures to put an end to that situation. Such measures may consist, for example, in injunctions, sanctions against directors and managers, or suspension of the exercise of the voting rights attaching to the shares held by the shareholders or members in question. Similar measures shall apply to natural or legal persons failing to comply with the obligation to provide prior information imposes in paragraph 1. If a holding is acquired despite the opposition of the competent authorities, the Member States shall, regardless of any other sanctions to be adopted, provide either for exercise of the corresponding voting rights to be suspended, or for the nullity of votes cast or for the possibility of their annulment. Article 16 1. The Member States shall provide that all persons working or who have worked for the competent authorities, as well as auditors and experts acting on behalf of the competent authorities, shall be bound by the obligation of professional secrecy. This means that no confidential information which they may receive while performing their duties may be divulged to any person or authority whatsoever, except in summary or aggregate form, such that individual insurance undertakings cannot be identified, without prejudice to cases covered by criminal law. Nevertheless, where an insurance undertaking has been declared bankrupt or is being compulsorily wound up, confidential information which does not concern third parties involved in attempts to rescue that undertaking may be divulged in civil or commercial proceedings. 2. Paragraph 1 shall not prevent the competent authorities of different Member States from exchanging information in accordance with the Directives applicable to insurance undertakings. Such information shall be subject to the conditions of professional secrecy laid down in paragraph 1. 3. Member States may conclude cooperation agreements, providing for exchanges of information, with the competent authorities of third countries only if the information disclosed is subject to guarantees of professional secrecy at least equivalent to those provided for in this Article. 4. Competent authorities receiving confidential information under paragraphs 1 or 2 may use it only in the course of their duties: - to check that the conditions governing the taking up of the business of insurance are met and to facilitate monitoring of the conduct of such business, especially with regard to the monitoring of technical provisions, solvency margins, administrative and accounting procedures and internal control mechanisms, - to impose sanctions, - in administrative appeals against decisions of the competent authorities, or - in court proceedings initiated under Article 56 or under special provisions provided for in the Directives adopted in the field of insurance undertakings. 5. Paragraphs 1 and 4 shall not preclude the exchange of information within a Member State, where there are two or more competent authorities in the same Member State, or, between Member States, between competent authorities and: - authorities responsible for the official supervision of credit institutions and other financial organizations and the authorities responsible for the supervision of financial markets, - bodies involved in the liquidation and bankruptcy of insurance undertakings and in other similar procedures, and - persons responsible for carrying out statutory audits of the accounts of insurance undertakings and other financial institutions, in the discharge of their supervisory functions, or the disclosure to bodies which administer compulsory winding-up proceedings or guarantee funds of information necessary to the performance of their duties. The information received by those authorities, bodies and persons shall be subject to the conditions of professional secrecy laid down in paragraph 1. 6. In addition, notwithstanding paragraphs 1 and 4, the Member States may, under provisions laid down by law, authorize the disclosure of certain information to other departments of their central government administrations responsible for legislation on the supervision of credit institutions, financial institutions, investment services and insurance companies and to inspectors acting on behalf of those departments. However, such disclosures may be made only where necessary for reasons of prudential control. The Member States shall, however, provide that information received under paragraphs 2 and 5 and that obtained by means of the on-the-spot verification referred to in Article 14 of Directive 73/239/EEC may never be disclosed in the cases referred to in this paragraph except with the express consent of the competent authorities which disclosed the information or of the competent authorities of the Member State in which on-the-spot verification was carried out. Chapter 2 Article 17 Article 15 of Directive 73/239/EEC shall be replaced by the following: 'Article 15 1. The home Member State shall require every insurance undertaking to establish adequate technical provisions in respect of its entire business. The amount of such technical provisions shall be determined in accordance with the rules laid down in Directive 91/674/EEC. 2. The home Member State shall require every insurance undertaking to cover the technical provisions in respect of its entire business by matching assets in accordance with Article 6 of Directive 88/357/EEC. In respect of risks situated within the European Community, those assets must be localized within the Communtiy. Member States shall not require insurance undertakings to localize their assets in any particular Member State. The home Member State may, however, permit relaxations in the rules on the localization of assets. 3. If the home Member State allows any technical provisions to be covered by claims against reinsurers, it shall fix the percentage so allowed. In such cases, it may not specify the localization of the assets representing such claims.' Article 18 Article 15a of Directive 72/239/EEC shall be replaced by the following: 'Article 15a 1. Member States shall require every insurance undertaking with a head office within their territories which underwrites risks included in class 14 in point A of the Annex (hereinafter referred to as "credit insurance") to set up an equalization reserve for the purpose of offsetting any technical deficit or above-average claims ration arising in that class in any financial year. 2. The equalization reserve shall be calculated in accordance with the rules laid down by the home Member State in accordance with one of the four methods set out in point D of the Annex, which shall be regarded as equivalent. 3. Up to the amount calculated in accordance with the methods set out in point D of the Annex, the equalization reserve shall be disregarded for the purpose of calculating the solvency margin. 4. Member States may exempt insurance undertakings with head offices within their territories from the obligation to set up equalization reserves for credit insurance business where the premiums or contributions receivable in respect of credit insurance are less than 4 % of the total premiums or contributions receivable by them and less than ECU 2 500 000.' Article 19 Article 23 of Directive 88/357/EEC is hereby repealed. Article 20 The assets covering the technical provisions shall take account of the type of business carried on by an undertaking in such a way as to secure the safety, yield and marketability of its investments, which the undertaking shall ensure are diversified and adequately spread. Article 21 1. The home Member State may not authorize insurance undertakings to cover their technical provisions with any but the following categories of assets: A. Investments (a) debt securities, bonds and other money and capital market instruments; (b) loans; (c) shares and other variable yield participations; (d) units in undertakings for collective investment in transferable securities and other investment funds; (e) land, buildings and immovable property rights; B. Debts and claims (f) debts owed by reinsurers, including reinsurers' shares of technical provisions; (g) deposits with and debts owed by ceding undertakings; (h) debts owed by policyholders and intermediaries arising out of direct and reinsurance operations; (i) claims arising out of salvage and subrogation; (j) tax recoveries; (k) claims against guarantee funds; C. Others (l) tangible fixed assets, other than land and buildings, valued on the basis of prudent amortization; (m) cash at bank and in hand, deposits with credit institutions and any other bodies authorized to receive deposits; (n) deferred acquisition costs; (o) accrued interest and rent, other accrued income and prepayments; In the case of the association of underwriters know as Lloyd's, asset categories shall also include guarantees and letters of credit issued by credit institutions within the meaning of Directive 77/780/EEC(12) or by assurance undertakings, together with verifiable sums arising out of life assurance policies, to the extent that they represent funds belonging to members. The inclusion of any asset or category of assets listed in the first subparagraph shall not mean that all categories of assets must automatically be accepted as cover for technical provisions. The home Member State shall lay down more detailed rules fixing the conditions for the use of acceptable assets; in this connection, it may require valuable security or guarantees, particularly in the case of debts owed by reinsurers. In the determination and the application of the rules which it lays down, the home Member State shall, in particular, ensure that the following principles are complied with: (i) assets covering technical provisions shall be valued net of any debts arising out of their acquisition; (ii) all assets must be valued on a prudent basis, allowing for the risk of any amounts' not being realizable. In particular, tangible fixed assets other than land and buildings may be accepted as cover for technical provisions only if they are valued on the basis of prudent amortization; (iii) loans, whether to undertakings, to State authorities or international organizations, to local or regional authorities or to natural persons, may be accepted as cover for technical provisions only if there are sufficient guarantees as to their security, whether these are based on the status of the borrower, mortgages, bank guarantees or guarantees granted by insurance undertakings or other forms of security; (iv) derivative instruments such as options, futures and swaps in connection with assets covering technical provisions may be used in so far as they contribute to a reduction of investment risks or facilitate efficient portfolio management. They must be valued on a prudent basis and may be taken into account in the valuation of the underlying assets; (v) transferrable securities which are not dealt in on a regulated market may be accepted as cover for technical provisions only if they can be realized in the short term; (vi) debts owed by and claims against a third party may be accepted as cover for technical provisions only after deduction of all amounts owed to the same third party; (vii) the value of any debts and claims accepted as cover for technical provisions must be calculated on a prudent basis, with due allowance for the risk of any amounts not being realizable. In particular, debts owed by policyholders and intermediaries arising out of insurance and reinsurance operations may be accepted only in so far as they have been outstanding for not more than three months; (viii) where the assets held include an investment in a subsidiary undertaking which manages all or part of the insurance undertaking's investments on its behalf, the home Member State must, when applying the rules and principles laid down in this Article, take into account the underlying assets held by the subsidiary undertaking; the home Member State may treat the assets of other subsidiaries in the same way; (ix) deferred acquisition costs may be accepted as cover for technical provisions only to the extent that that is consistent with the calculation of the technical provision for unearned premiums. 2. Notwithstanding paragraph 1, in exceptional circumstances and at an insurance undertaking's request, the home Member State may, temporarily and under a properly reasoned decision, accept other categories of assets as cover for technical provisions, subject to Article 20. Article 22 1. As regard the assets covering technical provisions, the home Member State shall require every insurance undertaking to invest no more than: (a) 10 % of its total gross technical provisions in any one piece of land or building, or a number of pieces of land or buildings close enough to each other to be considered effectively as one investment; (b) 5 % of its total gross technical provisions in shares and other negotiable securities treated as shares, bonds, debt securities and other money and capital market instruments from the same undertaking, or in loans granted to the same borrower, taken together, the loans being loans other than those granted to a State, regional or local authority or to an international organization of which one or more Member States are members. This limit may be raised to 10 % if an undertaking does not invest more than 40 % of its gross technical provisions in the loans or securities of issuing bodies and borrowers in each of which it invests more than 5 % of its assets; (c) 5 % of its total gross technical provisions in unsecured loans, including 1 % for any single unsecured loan, other than loans granted to credit institutions, assurance undertaking - in so far as Article 8 of Directive 73/239/EEC allows it - and investment undertakings established in a Member State; (d) 3 % of its total gross technical provisions in the form of cash in hand; (e) 10 % of its total gross technical provisions in shares, other securities treated as shares and debt securities, which are not dealt in on a regulated market. 2. The absence of a limit in paragraph 1 on investment in any particular category does not imply that assets in that category should be accepted as cover for technical provisions without limit. The home Member State shall lay down more detailed rules fixing the conditions for the use of acceptable assets. In particular it shall ensure, in the determination and the application of those rules, that the following principles are complied with: (i) assets covering technical provisions must be diversified and spread in such a way as to ensure that there is no excessive reliance on any particular category of asset, investment market or investment; (ii) investment in particular types of asset which show high levels of risk, whether because of the nature of the asset or the quality of the issuer, must be restricted to prudent levels; (iii) limitations on particular categories of asset must take account of the treatment of reinsurance in the calculation of technical provisions; (iv) where the assets held include an investment in a subsidiary undertaking which manages all or part of the insurance undertaking's investments on its behalf, the home Member State must, when applying the rules and principles laid down in this Article, take into account the underlying assets held by the subsidiary undertaking; the home Member State may treat the assets of other subsidiaries in the same way; (v) the percentage of assets covering technical provisions which are the subject of non-liquid investments must be kept to a prudent level; (vi) where the assets held include loans to or debt securities issued by certain credit institutions, the home Member State may, when applying the rules and principles laid down in this Article, take into account the underlying assets held by such credit institutions. This treatment may be applied only where the credit institution has its head office in a Member State, is entirely owned by that Member State and/or that State's local authorities and its business, according to its memorandum and articles of association, consists of extending, through its intermediary, loans to or guaranteed by the State or local authorities or loans to bodies closely linked to the State or to local authorities. 3. In the context of the detailed rules laying down the conditions for the use of acceptable assets, the Member State shall give more limitative treatment to: - any loan unaccompanied by a bank guarantee, a guarantee issued by an insurance undertaking, a mortgage or any other form of security, as compared with loans accompanied by such collateral, - Ucits not coordinated within the meaning of Directive 85/611/EEC(13) and other investment funds, as compared with Ucits coordinated within the meaning of that Directive, - securities which are not dealt in on a regulated market, as compared with those which are, - bonds, debt securities and other money and capitalmarket instruments not issued by States, local or regional authorities or undertakings belonging to Zone A as defined in Directive 89/647/EEC(14) , or the issuers of which are international organizations not numbering at least one Community Member State among their member, as compared with the same financial instruments issued by such bodies. 4. Member States may raise the limit laid down in paragraph 1 (b) to 40 % in the case of certain debt securities when these are issued by a credit institution which has its head office in a Member State and is subject by law to special official supervision designed to protect the holders of those debt securities. In particular, sums deriving from the issue of such debt securities must be invested in accordance with the law in assets which, during the whole period of validity of the debt securities, are capable of covering claims attaching to the debt securities and which, in the event of failure of the issues, would be used on a priority basis for the reimbursement of the principal and payment of the accrued interest. 5. Member States shall not require insurance undertakings to invest in particular categories of assets. 6. Notwithstanding paragraph 1, in exceptional circumstances and at an insurance undertaking's request, the home Member State may, temporarily and under a properly reasoned decision, allow exceptions to the rules laid down in paragraph 1 (a) to (e), subject to Article 20. Article 23 Points 8 and 9 of Annex 1 to Directive 88/357/EEC shall be replaced by the following: '8. Insurance undertakings may hold non-matching assets to cover an amount not exceeding 20 % of their commitments in a particular currency. 9. A Member State may provide that when under the preceding procedures a commitment must be covered by assets expressed in a Member State's currency that requirement shall also be considered as satisfied when the assets are expressed in ecus'. Article 24 Article 16 (1) of Directive 73/239/EEC shall be replaced by the following: '1. The home Member State shall require every insurance undertaking to establish an adequate solvency margin in respect of its entire business. The solvency margin shall correspond to the assets of the undertaking free of any foreseeable liabilities less any intangible items. In particular the following shall be included: - the paid-up share capital or, in the case of a mutual insurance undertaking, the effective initial fund plus any members' accounts which meet all the following criteria: (a) the memorandum and articles of association must stipulate that payments may be made from these accounts to members only insofar as this does not cause the solvency margin to fall below the required level, or, after the dissolution of the undertaking, if all the undertaking's other debts have been settled; (b) the memorandum and articles of association must stipulate, with respect to any such payments for reasons other than the individual termination of membership, that the competent authorities must be notified at least one month in advance and can prohibit the payment within that period and (c) the relevant provisions of the memorandum and articles of association may be amended only after the competent authorities have declared that they have no objection to the amendment, without prejudice to the criteria stated in (a) and (b); - one-half of the unpaid share capital or initial fund, once the paid-up part amounts to 25 % of that share capital or fund, - reserves (statutory reserves and free reserves) not corresponding to underwriting liabilities, - any profits brought forward, - in the case of mutual or mutal-type association with variable contributions, any claim which it has against its members by way of a call for supplementary contribution, within the financial year, up to one-half of the difference between the maximum contributions and the contributions actually called in, and subject to a limit of 50 % of the margin, - at the request of and on the production of proof by the insurance undertaking, any hidden reserves arising out of the undervaluation of assets, insofar as those hidden reserves are not of an exceptional nature, - cumulative preferential share capital and subordinated loan capital may be included but, if so, only up to 50 % of the margin, no more than 25 % of which shall consist of subordinated loans with a fixed maturity, or fixed-term cumulative preferential share capital, if the following minimum criteria are met: (a) in the event of the bankruptcy or liquidation of the insurance undertaking, binding agreements must exist under which the subordinated loan capital or preferential share capital ranks after the claims of all other creditors and is not to be repaid until all other debts outstanding at the time have been settled. Subordinated loan capital must fulfil the following additional conditions: (b) only fully paid-up funds may be taken into account; (c) for loans with a fixed maturity, the original maturity must be at least five years. No later than one year before the repayment date the insurance undertaking must submit to the competent authorities for their approval a plan showing how the solvency margin will be kept at or brought to the required level at maturity, unless the extent to which the loan may rank as a component of the solvency margin is gradually reduced during at least the last five years before the repayment date. The competent authorities may authorize the early repayment of such loans provided application is made by the issuing insurance undertaking and its solvency margin will not fall below the required level; (d) loans the maturity of which is not fixed must be repayable only subject to five years' notice unless the loans are no longer considered a component of the solvency margin or unless the prior consent of the competent authorities is specifically required for early repayment. In the latter event the insurance undertaking must notify the competent authorities at least six months before the date of the proposed repayment, specifying the actual and required solvency margins both before and after that repayment. The competent authorities shall authorize repayment only if the insurance undertaking's solvency margin will not fall below the required level; (e) the loan agreement must not include any clause providing that in specified circumstances, other than the winding-up of the insurance undertaking, the debt will become repayable before the agreed repayment dates; (f) the loan agreement may be amended only after the competent authorities have declared that they have no objection to the amendment; - securities with no specified maturity date and other instruments that fulfil the following conditions, including cumulative preferential shares other than those mentioned in the preceding indent, up to 50 % of the margin for the total of such securities and the subordinated loan capital referred to in the preceding indent: (a) they may not be repaid on the initiative of the bearer or without the prior consent of the competent authority; (b) the contract of issue must enable the insurance undertaking to defer the payment of interest on the loan; (c) the lender's claims on the insurance undertaking must rank entirely after those of all non-subordinated creditors; (d) the documents governing the issue of the securities must provide for the loss-absorption capacity of the debt and unpaid interest, while enabling the insurance undertaking to continue its business; (e) only fully paid-up amounts may be taken into account.' Article 25 No more than three years after the date of application of this Directive the Commission shall submit a report to the Insurance Committee on the need for further harmonization of the solvency margin. Article 26 Article 18 of Directive 79/239/EEC shall be replaced by the following: 'Article 18 1. Member States shall not prescribe any rules as to the choice of the assets that need not be used as cover for the technical provisions referred to in Article 15. 2. Subject to Article 15 (2), Article 20 (1), (2), (3) and (5) and the last subparagraph of Article 22 (1), Member States shall not restrain the free disposal of those assets, whether movable or immovable, that form part of the assets of authorized insurance undertakings. 3. Paragraphs 1 and 2 shall not preclude any measures which Member States, while safeguarding the interests of the isured persons, are entitled to take as owners or members of or partners to the undertakings in question.' Chapter 3 Article 27 Article 7 (1) (f) of Directive 88/357/EEC shall be replaced by the following: '(f) in the case of the risks referred to in Article 5 (d) of Directive 73/239/EEC, the parties to the contract may choose any law.' Article 28 The Member State in which a risk is situated shall not prevent a policyholder from concluding a contract with an insurance undertaking authorized under the conditions of Article 6 of Directive 73/239/EEC, as long as that does not conflict with legal provisions protecting the general good in the Member State in which the risk is situated. Article 29 Member States shall not adopt provisions requiring the prior approval or systematic notification of general and special policy conditions, scales of premiums, or forms and other printed documents which an insurance undertaking intends to use in its dealings with policy-holders. They may only require non-systematic notification of those policy conditions and other documents for the purpose of verifying compliance with national provisions concerning insurance contracts, and that requirement may not constitute a prior condition for an undertaking's carrying on its business. Member States may not retain or introduce prior notification or approval of proposed increases in premium rates except as part of general price-control systems. Article 30 1. Article 8 (4) (b) of Directive 88/357/EEC shall be deleted. Article 8 (4) (a) of that Directive shall therefore be amended to read as follows: '(a) Subject to subparagraph (c), the third subparagraph of Article 7 (2) shall apply where the insurance contract provides cover in two or more Member States, at least one of which makes insurance compulsory.' 2. Notwithstanding any provision to the contrary, a Member State which makes insurance compulsory may require that the general and special conditions of the compulsory insurance be communicated to its competent authority before being circulated. Article 31 1. Before an insurance contract is concluded the insurance undertaking shall inform the policyholder of: - the law applicable to the contract where the parties do not have a free choice, or the fact that the parties are free to choose the law applicable and, in the latter case, the law the insurer proposes to choose, - the arrangements for handling policyholders' complaints concerning contracts including, where appropriate, the existence of a complaints body, without prejudice to the policyholders's right to take legal proceedings. 2. The obligation referred to in paragraph 1 shall apply only where the policyholder is a natural person. 3. The rules for implementing this Article shall be determined in accordance with the law of the Member State in which the risk is situated. TITLE IV PROVISIONS RELATING TO RIGHT OF ESTABLISHMENT AND THE FREEDOM TO PROVIDE SERVICES Article 32 Article 10 of Directive 73/239/EEC shall be replaced by the following: 'Article 10 1. An insurance undertaking that proposes to establish a branch within the territory of another Member State shall notify the competent authorities of its home Member State. 2. The Member States shall require every insurance undertaking that proposes to establish a branch within the territory of another Member State to provide the following information when effecting the notification provided for in paragraph 1: (a) the Member State within the territory of which it proposes to establish a branch; (b) a scheme of operations setting out, inter alia, the types of business envisaged and the structural organization of the branch; (c) the address in the Member State of the branch from which documents may be obtained and to which they may be delivered, it being understood that that address shall be the one to which all communications to the authorized agent are sent; (d) the name of the branch's authorized agent, who must possess sufficient powers to bind the undertaking in relation to third parties and to represent it in relations with the authorities and courts of the Member State of the branch. With regard to Lloyd's, in the event of any litigation in the Member State of the branch arising out of underwritten commitments, the insured persons must not be treated less favourably than if the litigation had been brought against businesses of a conventional type. The authorized agent must, therefore, possess sufficient powers for proceedings to be taken against him and must in that capacity be able to bind the Lloyd's underwriters concerned. Where the undertaking intends its branch to cover risks in class 10 of point A of the Annex, not including carrier's liability, it must produce a declaration that it has become a member of the national bureau and the national guarantee fund of the Member State of the branch. 3. Unless the competent authorities of the home Member State have reason to doubt the adequacy of the administrative structure or the financial situation of the insurance undertaking or the good repute and professional qualifications or experience of the directors or managers or the authorized agent, taking into account the business planned, they shall within three months of receiving all the information referred to in paragraph 2 communicate that information to the competent authorities of the Member State of the branch and shall inform the undertaking concerned accordingly. The competent authorities of the home Member State shall also attest that the insurance undertaking has the minimum solvency margin calculated in accordance with Articles 16 and 17. Where the competent authorities of the home Member State refuse to communicate the information referred to in paragraph 2 to the competent authorities of the Member State of the branch they shall give the reasons for their refusal to the undertaking concerned within three months of receiving all the information in question. That refusal or failure to act may be subject to a right to apply to the courts in the home Member State. 4. Before the branch of an insurance undertaking starts business, the competent authorities of the Member State of the branch shall, within two months of receiving the information referred to in paragraph 3, inform the competent authority of the home Member State, if appropriate, of the conditions under which, in the interest of the general good, that business must be carried on in the Member State of the branch. 5. On receiving a communication from the competent authorities of the Member State of the branch or, if no communication is received from them, on expiry of the period provided for in paragraph 4, the branch may be established and start business. 6. In the event of a change in any of the particulars communicated under paragraph 2 (b), (c) or (d), an insurance undertaking shall give written notice of the change to the competent authorities of the home Member State and of the Member State of the branch at least one month before making the change so that the competent authorities of the home Member State and the competent authorities of the Member State of the branch may fulfil their respective roles under paragraphs 3 and 4.' Article 33 Article 11 of Directive 73/239/EEC is hereby repealed. Article 34 Article 14 of Directive 88/357/EEC shall be replaced by the following: 'Article 14 Any undertaking that intends to carry on business for the first time in one or more Member States under the freedom to provide services shall first inform the competent authorities of the home Member State, indicating the nature of the risks it proposes to cover.' Article 35 Article 16 of Directive 88/357/EEC shall be replaced by the following: 'Article 16 1. Within one month of the notification provided for in Article 14, the competent authorities of the home Member State shall communicate to the Member State or Member States within the territories of which an undertaking intends to carry on business under the freedom to provide services: (a) a certificate attesting that the undertaking has the minimum solvency margin calculated in accordance with Articles 16 and 17 of Directive 73/239/EEC; (b) the classes of insurance which the undertaking has been authorized to offer; (c) the nature of the risks which the undertaking proposes to cover in the Member State of the provision of services. At the same time, they shall inform the undertaking concerned accordingly. Each Member State within the territory of which an undertaking intends, under the freedom to provide services, to cover risks in class 10 of point A of the Annex to Directive 73/239/EEC other than carrier's liability may require that the undertaking: - communicate the name and address of the representative referred to in Article 12a (4) of this Directive, - produce a declaration that the undertaking has become a member of the national bureau and national guarantee fund of the Member State of the provision of services. 2. Where the competent authorities of the home Member State do not communicate the information referred to in paragraph 1 within the period laid down, they shall give the reasons for their refusal to the undertaking within that same period. That refusal shall be subject to a right to apply to the courts in the home Member State. 3. The undertaking may start business on the certified date on which it is informed of the communication provided for in the first subparagraph of paragraph 1.' Article 36 Article 17 of Directive 88/357/EEC shall be replaced by the following: 'Article 17 Any change which an undertaking intends in make to the information referred to in Article 14 shall be subject to the procedure provided for in Articles 14 and 16.' Article 37 Article 12 (2), second and third subparagraphs, Article 12 (3) and Articles 13 and 15 of Directive 88/357/EEC are hereby repealed. Article 38 The competent authorities of the Member State of the branch or the Member State of the provision of services may require that the information which they are authorized under this Directive to request with regard to the business of insurance undertakings operating in the territory of that State shall be supplied to them in the official language or languages of that State. Article 39 1. Article 18 of Directive 88/357/EEC is hereby repealed. 2. The Member State of the branch or of the provision of services shall not adopt provisions requiring the prior approval or systematic notification of general and special policy conditions, scales of premiums, or forms and other printed documents which an undertaking intends to use in its dealings with policyholders. It may only require an undertaking that proposes to carry on insurance business within its territory, under the right of establishment or the freedom to provide services, to effect non-systematic notification ot those policy conditions and other documents for the purpose of verifying compliance with its national provisions concerning insurance contracts, and that requirement may not constitute a prior condition for an undertaking's carrying on its business. 3. The Member State of the branch or of the provision of services may not retain or introduce prior notification or approval of proposed increases in premium rates except as part of general price-control systems. Article 40 1. Article 19 of Directive 88/357/EEC is hereby repealed. 2. Any undertaking carrying on business under the right of establishment or the freedom to provide services shall submit to the competent authorities of the Member State of the branch and/or of the Member State of the provision of services all documents requested of it for the purposes of this Article in so far as undertakings with head offices in those Member States are also obliged to do so. 3. If the competent authorities of a Member State establish that an undertaking with a branch or carrying on business under the freedom to provide services within its territory is not complying with the legal provisions applicable to it in that State, they shall require the undertaking concerned to remedy that irregular situation. 4. If the undertaking in question fails to take the necessary action, the competent authorities of the Member State concerned shall inform the competent authorities of the home Member State accordingly. The latter authorities shall, at the earliest opportunity, take all appropriate measures to ensure that the undertaking concerned remedies that irregular situation. The nature of those measures shall be communicated to the competent authorities of the Member State concerned. 5. If, despite the measures taken by the home Member State or because those measures prove inadequate or are lacking in that State, the undertaking persists in infringing the legal provisions in force in the Member State concerned, the latter may, after informing the competent authorities of the home Member State, take appropriate measures to prevent or penalize further infringements, including, in so far as is strictly necessary, preventing that undertaking from continuing to conclude new insurance contracts within its territory. Member States shall ensure that within their territories it is possible to serve the legal documents necessary for such measures on insurance undertakings. 6. Paragraphs 3, 4 and 5 shall not affect the emergency power of the Member States concerned to take appropriate measures to prevent irregularities within their territories. This shall include the possibility of preventing insurance undertakings from continuing to conclude new insurance contracts within their territories. 7. Paragraphs 3, 4 and 5 shall not affect the powers of the Member States to penalize infringements within their territories. 8. If an undertaking which has committed an infringement has an establishment or possesses property in the Member State concerned, the competent authorities of the latter may, in accordance with national law, apply the administrative penalties prescribed for that infringement by way of enforcement against that establishment or property. 9. Any measure adopted under paragraphs 4 to 8 involving penalties or restrictions on the conduct of insurance business must be properly reasoned and communicated to the undertaking concerned. 10. Every two years, the Commission shall submit to the Insurance Committee set up by Directive 91/675/EEC a report summarizing the number and types of cases in which, in each Member State, authorization has been refused under Article 10 of Directive 73/239/EEC or Article 16 of Directive 88/357/EEC as amended by this Directive or measures have been taken under paragraph 5. Member States shall cooperate with the Commission by providing it with the information required for that report. Article 41 Nothing in this Directive shall prevent insurance undertakings with head offices in Member States from advertising their services, through all available means of communication, in the Member State of the branch or the Member State of the provision of services, subject to any rules governing the form and content of such advertising adopted in the interest of the general good. Article 42 1. Article 20 of Directive 88/357/EEC is hereby repealed. 2. In the event of an insurance undertaking's being wound up, commitments arising out of contracts underwritten through a branch or under the freedom to provide services shall be met in the same way as those arising out of that undertaking's other insurance contracts, without distinction as to nationality as far as the persons insured and the beneficiaries are concerned. Article 43 1. Article 21 of Directive 88/357/EEC is hereby repealed. 2. Where insurance is offered unter the right of establishment or the freedom to provide services, the policyholder shall, before any commitment is entered into, be informed of the Member State in which the head office or, where appropriate, the branch with which the contract is to be concluded is situated. Any documents issued to the policyholder must convey the information referred to in the first subparagraph. The obligations imposed in the first two subparagraghs shall not apply to the risks referred to in Article 5 (d) of Directive 73/239/EEC. 3. The contract or any other document granting cover, together with the insurance proposal where it is binding upon the policyholder, must state the address of the head office, or, where appropriate, of the branch of the insurance undertaking which grants the cover. Each Member State may require that the name and address of the representative of the insurance undertaking referred to in Article 12 a (4) of Directive 88/357/EEC also appear in the documents referred to in the first subparagraph. Article 44 1. Article 22 of Directive 88/357/EEC is hereby repealed. 2. Every insurance undertaking shall inform the competent authority of its home Member State, separately in respect of transactions carried out under the right of establishment and those carried out under the freedom to provide services, of the amount of the premiums, claims and commisions, without deduction of reinsurance, by Member State and by group of classes, and also as regards class 10 of point A of the Annex to Directive 73/239/EEC, not including carrier's liability, the frequency and average cost of claims. The groups of classes are hereby defined as follows: - accident and sickness (classes 1 and 2), - motor (classes 3, 7 and 10, the figures for class 10, excluding carriers' liability, being given separately), - fire and other damage to property (classes 8 and 9), - aviation, marine and transport (classes 4, 5, 6, 7, 11 and 12), - general liability (class 13), - credit and suretyship (classes 14 and 15), - other classes (classes 16, 17 and 18). The competent authority of the home Member State shall forward that information within a reasonable time and in aggregate form to the competent authorities of each of the Member States concerned which so request. Article 45 1. Article 24 of Directive 88/357/EEC is hereby repealed. 2. Nothing in this Directive shall affect the Member States' right to require undertakings carrying on business within their territories under the right of establishment or the freedom to provide services to join and participate, on the same terms as undertakings authorized there, in any scheme designed to guarantee the payment of insurance claims to insured persons and injured third parties. Article 46 1. Article 25 of Directive 88/357/EEC is hereby repealed. 2. Without prejudice to any subsequent harmonization, every insurance contract shall be subject exclusively to the indirect taxes and parafiscal charges on insurance premiums in the Member State in which the risk is situated as defined in Article 2 (d) of Directive 88/357/EEC, and also, in the case of Spain, to the surcharges legally established in favour of the Spanish 'Consorcio de Compensación de Seguros' for the performance of its functions relating to the compensation of losses arising from extraordinary events occurring in that Member State. In derogation from the first indent of Article 2 (d) of Directive 88/357/EEC, and for the purposes of this paragraph, moveable property contained in a building situated within the territory of a Member State, except for goods in commercial transit, shall be a risk situated in that Member State, even if the building and its contents are not covered by the same insurance policy. The law applicable to the contract under Article 7 of Directive 88/357/EEC shall not affect the fiscal arrangements applicable. Pending future harmonization, each Member State shall apply to those undertakings which cover risks situated within its territory its own national provisions to ensure the collection of indirect taxes and parafiscal charges due under the first subparagraph. TITLE V TRANSITIONAL PROVISIONS Article 47 n thaij>The Federal Republic of Germany may postpone until 1 January 1996 the application of the first sentence of the second subparagraph of Article 54 (2). During that period, the provisions of the following subparagraph shall apply in the situation referred to in Article 54 (2). When the technical basis for the calculation of premiums has been communicated to the competent authorities of the home Member State in accordance with the third sentence of the second subparagraph of Article 54 (2), those authorities shall without delay forward that information to the competent authorities of the Member State in which the risk is sItuated so that they may comment. If the competent authorities of the home Member State take no account of those comments, they shall inform the competent authorities of the Member State in which the risk is situated accordingly in detail and state their reasons. Article 48 Member States may allow insurance undertakings with head offices in their territories, the buildings and land of which that cover their technical provisions exceed, at the time of the notification of this Directive, the percentage laid down in Article 22 (1) (a), a period expiring no later than 31 December 1998 within which to comply with that provision. Article 49 The Kingdom of Denmark may postpone until 1 January 1999 the application of this Directive to compulsory insurance against accidents at work. During that period the exclusion provided for in Article 12 (2) of Directive 88/357/EEC for accidents at work shall continue to apply in the Kingdom of Denmark. Article 50 Spain, until 31 December 1996, and Greece and Portugal, until 31 December 1998, may operate the following transitional arrangements for contracts covering risks situated exclusively in one of those Member States other than those defined in Article 5 (d) of Directive 73/239/EEC: (a) in derogation from Article 8 (3) of Directive 73/239/EEC and from Articles 29 and 39 of this Directive, the competent authorities of the Member States in question may require the communication, before use, of general and special insurance policy conditions; (b) the amount of the technical provisions relating to the contracts referred to in this Article shall be determined under the supervision of the Member State concerned in accordance with its own rules or, failing that, in accordance with the procedures established within its territory in accordance with this Directive. Cover of those technical provisions by equivalent and matching assets and the localization of those assets shall be effected under the supervision of that Member State in accordance with its rules and practices adopted in accordance with this Directive. TITLE VI FINAL PROVISIONS Article 51 The following technical adjustments to be made to Directives 73/239/EEC and 88/357/EEC and to this Directive shall be adopted in accordance with the procedure laid down in Directive 91/675/EEC: - extension of the legal forms provided for in Article 8 (1) (a) of Directive 73/239/EEC, - amendments to the list set out in the Annex to Directive 73/239/EEC, or adaptation of the terminology used in that list to take account of the development of insurance markets, - clarification of the items constituting the solvency margin listed in Article 16 (1) of Directive 73/239/EEC to take account of the creation of new financial instruments, - alteration of the minimum guarantee fund provided for in Article 17 (2) of Directive 73/239/EEC to take account of economic and financial developments, - amendments, to take account of the creation of new financial instruments, to the list of assets acceptable as cover for technical provisions set out in Article 21 of this Directive and to the rules on the spreading of investments laid down in Article 22, - changes in the relaxations in the matching rules laid down in Annex 1 to Directive 88/357/EEC, to take account of the development of new currency-hedging instruments or progress made towards economic and monetary union, - clarification of the definitions in order to ensure uniform application of Directives 73/239/EEC and 88/357/EEC and of this Directive throughout the Community. Article 52 1. Branches which have started business, in accordance with the provisions in force in their Member State of establishment, before the entry into force of the provisions adopted in implementation of this Directive shall be presumed to have been subject to the procedure laid down in Article 10 (1) to (5) of Directive 73/239/EEC. They shall be governed, from the date of that entry into force, by Articles 15, 19, 20 and 22 of Directive 73/239/EEC and by Article 40 of this Directive. 2. Articles 34 and 35 shall not affect rights acquired by insurance undertakings carrying on business under the freedom to provide services before the entry into force of the provisions adopted in implementation of this Directive. Article 53 The following Article shall be inserted in Directive 73/239/EEC: 'Article 28a 1. Under the conditions laid down by national law, each Member State shall authorize agencies and branches set up within its territory and covered by this Title to transfer all or part of their portfolios of contracts to an accepting office established in the same Member State if the competent authorities of that Member State or, if appropriate, of the Member State referred to in Article 26 certify that after taking the transfer into account the accepting office possesses the necessary solvency margin. 2. Under the conditions laid down by national law, each Member State shall authorize agencies and branches set up within its territory and covered by this Title to transfer all or part of their portfolios of contracts to an insurance undertaking with a head office in another Member State if the competent authorities of that Member State certify that after taking the transfer into account the accepting office possesses the necessary solvency margin. 3. If under the conditions laid down by national law a Member State authorizes agencies and branches set up within its territory and covered by this Title to transfer all or part of their portfolios of contracts to an agency or branch covered by this Title and set up within the territory of another Member State it shall ensure that the competent authorities of the Member State of the accepting office or, if appropriate, of the Member State referred to in Article 26 certify that after taking the transfer into account the accepting office possesses the necessary solvency margin, that the law of the Member State of the accepting office permits such a transfer and that that State has agreed to the transfer. 4. In the circumstances referred to in paragraphs 1, 2 and 3 the Member State in which the transferring agency or branch is situated shall authorize the transfer after obtaining the agreement of the competent authorities of the Member State in which the risks are situated, where different from the Member State in which the transferring agency or branch is situated. 5. The competent authorities of the Member States consulted shall give their opinion or consent to the competent authorities of the home Member State of the transferring insurance undertaking within three months of receiving a request; the absence of any response from the authorities consulted within that period shall be considered equivalent to a favourable opinion or tacit consent. 6. A transfer authorized in accordance with this Article shall be published as laid down by national law in the Member State in which the risk is situated. Such transfers shall automatically be valid against policyholders, insured persons and any other persons having rights or obligations arising out of the contracts transferred. This provision shall not affect the Member States' right to give policyholders the option of cancelling contracts within a fixed period after a transfer.' Article 54 1. Notwithstanding any provision to the contrary, a Member State in which contracts covering the risks in class 2 of point A of the Annex to Directive 73/239/EEC may serve as a partial or complete alternative to health cover provided by the statutory social security system may requrie that those contracts comply with the specific legal provisions adopted by that Member State to porotect the general good in that class of insurance, and that the general and special conditions of that insurance be communicated to the competent authorities of that Member State before use. 2. Member States may require that the health insurance system referred to in paragraph 1 be operated on a technical basis similar to that of life assurance where: - the premiums paid are calculated on the basis of sickness tables and other statistical data relevant to the Member State in which the risk is situated in accordance with the mathematical methods used in insurance, - a reserve is set up for increasing age, - the insurer may cancel the contract only within a fixed period determined by the Member State in which the risk is situated, - the contract provides that premiums may be increased or payments reduced, even for current contracts, - the contract provides that the policyholder may change his existing contract into a new contract complying with paragraph 1, offered by the same insurance undertaking or the same branch and taking account of his acquired rights. In particular, account must be taken of the reserve for increasing age and a new medical examination may be required only for increased cover. In that event, the competent authorities of the Member State concerned shall publish the sickness tables and other relevant statistical data referred to in the first subparagraph and transmit them to the competent authorities of the home Member State. The premiums must be sufficient, on rasonable actuarial assumptions, for undertakings to be able to meet all their commitments having regard to all aspects of their financial situation. The home Member State shall require that the technical basis for the calculation of premiums be communicated to its competent authorities before the product is circulated. This paragraph shall also apply where existing contracts are modified. Article 55 Member States may require that any insurance undertaking offering, at its own risk, compulsory insurance against accidents at work within their territories comply with the specific provisions of their national law concerning such insurance, except for the provisions concerning financial supervision, which shall be the exclusive responsibility of the home Member State. Article 56 Member States shall ensure that decisions taken in respect of an isurance undertaking under laws, regulations and administrative provisions adopted in accordance with this Directive may be subject to the right to apply to the courts. Article 57 1. The Member States shall adopt the laws, regulations and administrative provisions necessary for their compliance with this Directive not later than 31 December 1993 and bring them into force no later than 1 July 1994. They shall forthwith inform the Commission thereof. When they adopt such measures the Member States shall include references to this Directive or shall make such references when they effect official publication. The manner in which such references are to be made shall be laid down by the Member States. 2. The Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 58 This Directive is addressed to the Member States.

31992L0050

1992

Council Directive 92/50/EEC of 18 June 1992 relating to the coordination of procedures for the award of public service contracts Having regard to the Treaty establishing the European Economic Community, and in particular the last sentence of Article 57 (2) and Article 66 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 the European Council has drawn conclusions on the need to complete the internal market; Whereas measures aimed at progressively establishing the internal market during the period up to 31 December 1992 need to be taken; whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas these objectives require the coordination of the procurement procedures for the award of public service contracts; Whereas the White Paper on the completion of the internal market contains an action programme and a timetable for opening up public procurement, including in the field of services insofar as this is not already covered by Council Directive 71/305/EEC of 26 July 1971 concerning the coordination of procedures for the award of public works contracts(4) and Council Directive 77/62/EEC of 21 december 1976 coordinating procedures for the award of public supply contracts(5); Whereas this Directive should be applied by all contracting authorities within the meaning of Directive 71/305/EEC; Whereas obstacles to the free movement of services need to be avoided; whereas, therefore, service providers may be either natural or legal persons; whereas this Directive shall not, however, prejudice the application, at national level, of rules concerning the conditions for the pursuit of an activity or a profession provided that they are compatible with Community law; Whereas the field of services is best described, for the purpose of application of procedural rules and for monitoring purposes, by subdividing it into categories corresponding to particular positions of a common classification; whereas Annexes I A and I B of this Directive refer to the CPC nomenclature (common product classification) of the United Nations; whereas that nomenclature is likely to be replaced in the future by Community nomenclature; whereas provision should be made for adapting the CPC nomenclature in Annexes I A and B in consequence; Whereas the provision of services is covered by this Directive only in so far as it is based on contracts; whereas the provision of services on other bases, such as law or regulations, or employment contracts, is not covered; Whereas, in accordance with Article 130f of the Treaty, the encouragement of research and development is a means to strengthen the scientific and technological basis of European industry and the opening up of public contracts will contribute to this end; whereas contributions to the financing of research programmes should not be subject to this Directive; whereas research and development service contracts other than those where the benefits accrue exclusively to the contracting authority for its use in the conduct of its own affairs, on condition that the service provided is wholly remunerated by the contracting authority, are not therefore covered by this Directive; Whereas contracts relating to the acquisition or rental of immovable property or to rights thereon have particular characteristics, which make the application of procurement rules inappropriate; Whereas the award of contracts for certain audiovisual services in the broadcasting field is governed by considerations which make the application of procurement rules inappropriate; Whereas arbitration and conciliation services are usually provided by bodies or individuals which are agreed on, or selected, in a manner which cannot be governed by procurement rules; Whereas for the purposes of this Directive financial services do not include the instruments of monetary, exchange rate, public debt, reserve management, and other policies involving transactions in securities and other financial instruments; whereas, therefore, contracts in connection with the issue, sale, purchase or transfer of securities and other financial instruments are not covered by this Directive; whereas central bank services are also excluded; Whereas, in the field of services, the same derogations as in Directives 71/305/EEC and 77/62/EEC should apply as regards State security or secrecy and the priority of other procurement rules such as those pursuant to international agreements, those concerning the stationing of troops, or the rules of international organizations; Whereas this Directive does not prejudice the application of, in particular, Articles 55, 56 and 66 of the Treaty; Whereas public service contracts, particularly in the field of property management, may from time to time include some works; whereas it results from Directive 71/305/EEC that, for a contract to be a public works contract, its object must be the achievement of a work; whereas, in so far as these works are incidental rather than the object of the contract, they do not justify treating the contract as a public works contract; Whereas the rules concerning service contracts as contained in Council Directive 90/531/EEC of 17 September 1990 on the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors(6) should remain unaffected by this Directive; Whereas contracts with a designated single source of supply may, under certain conditions, be fully or partly exempted from this Directive; Whereas this Directive should not apply to small contracts below a certain threshold in order to avoid unnecessary formalities; whereas this threshold may in principle be the same as that for public supply contracts; whereas the calculation of the contract value, the publication and the method of adaptation of the thresholds should be the same as in the other Community procurement directives; Whereas, to eliminate practices that restrict competition in general and participation in contracts by other Member States' nationals in particular, it is necessary to improve the access of service providers to procedures for the award of contracts; Whereas full application of this Directive must be limited, for a transitional period, to contracts for those services where its provisions will enable the full potential for increased cross-frontier trade to be realized; whereas contracts for other services need to be monitored for a certain period before a decision is taken on the full application of this Directive; whereas the mechanism for such monitoring needs to be defined; whereas this mechanism should at the same time enable those interested to share the relevant information; Whereas the rules for the award of public service contracts should be as close as possible to those concerning public supply contracts and public works contracts; Whereas the procurement rules contained in Directives 71/305/EEC and 77/62/EEC can be appropriate, with necessary adaptations so as to take into account special aspects of procurement of services such as the choice of the negotiated procedure, design contests, variants, the legal form under which the service providers operate, the reservation of certain activities to certain professions, registration and quality assurance; Whereas use may be made of the negotiated procedure with prior publication of a notice when the service to be provided cannot be specified with sufficient precision, particularly in the field of intellectual services, with the result that such a contract cannot be awarded by selection of the best tender in accordance with the rules governing the open and restricted procedures; Whereas the relevant Community rules on mutual recognition of diplomas, certificates or other evidence of formal qualifications apply when evidence of a particular qualification is required for participation in an award procedure or a design contest; Whereas the objectives of this Directive do not require any changes in the current situation at national level as regards price competition between service providers of certain services; Whereas the operation of this Directive should be reviewed at the latest three years after the date set for procurement rules to be transposed into national law; whereas the review should extend in particular to the possibility of making the Directive fully applicable to a wider range of service contracts, TITLE I General provisions Article 1 For the purposes of this Directive: (a) public service contracts shall mean contracts for pecuniary interest concluded in writing between a service provider and a contracting authority, to the exclusion of: (i) public supply contracts within the meaning of Article 1 (a) of Directive 77/62/EEC or public works contracts within the meaning of Article 1 (a) of Directive 71/305/EEC; (ii) contracts awarded in the fields referred to in Articles 2, 7, 8 and 9 of Directive 90/531/EEC or fulfilling the conditions in Article 6 (2) of the same Directive; (iii) contracts for the acquisition or rental, by whatever financial means, of land, existing buildings, or other immovable property or concerning rights thereon; nevertheless, financial service contracts concluded at the same time as, before or after the contract of acquisition or rental, in whatever form, shall be subject to this Directive; (iv) contracts for the acquisition, development, production or co-production of programme material by broadcasters and contracts for broadcasting time; (v) contracts for voice telephony, telex, radiotelephony, paging and satellite services; (vi) contracts for arbitration and conciliation services; (vii) contracts for financial services in connection with the issue, sale, purchase or transfer of securities or other financial instruments, and central bank services; (viii) employment contracts; (ix) research and development service contracts other than those where the benefits accrue exclusively to the contracting authority for its use in the conduct of its own affairs, on condition that the service provided is wholly remunerated by the contracting authority; (b) contracting authorities shall mean the State, regional or local authorities, bodies governed by public law, associations formed by one or more of such authorities or bodies governed by public law. Body governed by public law means any body: - established for the specific purpose of meeting needs in the general interest, not having an industrial or commercial character, and - having legal personality and - financed, for the most part, by the State, or regional or local authorities, or other bodies governed by public law; or subject to management supervision by those bodies; or having an administrative, managerial or supervisory board, more than half of whose members are appointed by the State, regional or local authorities or by other bodies governed by public law. The lists of bodies or of categories of such bodies governed by public law which fulfil the criteria referred to in the second subparagraph of this point are set out in Annex I to Directive 71/305/EEC. These lists shall be as exhaustive as possible and may be reviewed in accordance with the procedure laid down in Article 30b of that Directive; (c) service provider shall mean any natural or legal person, including a public body, which offers services. A service provider who submits a tender shall be designated by the term tenderer and one who has sought an invitation to take part in a restricted or negotiated procedure by the term candidate; (d) open procedures shall mean those national procedures whereby all interested service providers may submit a tender; (e) restricted procedures shall mean those national procedures whereby only those service providers invited by the authority may submit a tender; (f) negotiated procedures shall mean those national procedures whereby authorities consult service providers of their choice and negotiate the terms of the contract with one or more of them; (g) design contests shall mean those national procedures which enable the contracting authority to acquire, mainly in the fields of area planning, town planning, architecture and civil engineering, or data processing, a plan or design selected by a jury after being put out to competition with or without the award of prizes. Article 2 If a public contract is intended to cover both products within the meaning of Directive 77/62/EEC and services within the meaning of Annexes I A and I B to this Directive, it shall fall within the scope of this Directive if the value of the services in question exceeds that of the products covered by the contract. Article 3 1. In awarding public service contracts or in organizing design contests, contracting authorities shall apply procedures adapted to the provisions of this Directive. 2. Contracting authorities shall ensure that there is no discrimination between different service providers. 3. Member States shall take the necessary measures to ensure that the contracting authorities comply or ensure compliance with this Directive where they subsidize directly by more than 50 % a service contract awarded by an entity other than themselves in connection with a works contract within the meaning of Article 1a (2) of Directive 71/305/EEC. Article 4 1. This Directive shall apply to public service contracts awarded by contracting authorities in the field of defence, except for contracts to which the provisions of Article 223 of the Treaty apply. 2. This Directive shall not apply to services which are declared secret or the execution of which must be accompanied by special security measures in accordance with the laws, regulations or administrative provisions in force in the Member State concerned or when the protection of the basic interests of that State's security so requires. Article 5 This Directive shall not apply to public contracts governed by different procedural rules and awarded: (a) in pursuance of an international agreement concluded between a Member State and one or more third countries and covering services intended for the joint implementation or exploitation of a project by the signatory States; any agreement shall be communicated to the Commission, which may consult the Advisory Committee for Public Contracts set up by Council Decision 71/306/EEC(7); (b) to undertakings in a Member State or a third country in pursuance of an international agreement relating to the stationing of troops; (c) pursuant to the particular procedure of an international organization. Article 6 This Directive shall not apply to public service contracts awarded to an entity which is itself a contracting authority within the meaning of Article 1 (b) on the basis of an exclusive right which it enjoys pursuant to a published law, regulation or administrative provision which is compatible with the Treaty. Article 7 1. This Directive shall apply to public service contracts, the estimated value of which, net of VAT, is not less than ECU 200000. 2. For the purposes of calculating the estimated value of the contract, the contracting authority shall include the estimated total remuneration of the service provider, taking account of the provisions of paragraphs 3 to 8. 3. The selection of the valuation method shall not be used with the intention of avoiding the application of this Directive, nor shall any procurement requirement for a given amount of services be split up with the intention of avoiding the application of this Article. 4. For the purposes of calculating the estimated contract value for the following types of services, account shall be taken, where appropriate: - as regards insurance services, of the premium payable, - as regards banking and other financial services, of fees, commissions and interest as well as other types of remuneration, - as regards contracts which involve design, of the fee or commission payable. Where the services are subdivided into several lots, each one the subject of a contract, the value of each lot must be taken into account for the purpose of calculating the amount referred to above. Where the value of the lots is not less than this amount, the provisions of this Directive shall apply to all lots. Contracting authorities may waive application of paragraph 1 for any lot which has an estimated value net of VAT of less than ECU 80000, provided that the total value of such lots does not exceed 20 % of the total value of all the lots. 5. In the case of contracts which do not specify a total price, the basis for calculating the estimated contract value shall be: - in the case of fixed-term contracts, where their term is 48 months or less, the total contract value for its duration; - in the case of contracts of indefinite duration or with a term of more than 48 months, the monthly instalment multiplied by 48. 6. In the case of regular contracts or of contracts which are to be renewed within a given time, the contract value may be established on the basis of: - either the actual aggregate cost of similar contracts for the same categories of services awarded over the previous fiscal year or 12 months, adjusted, where possible, for anticipated changes in quantity or value over the twelve months following the initial contract, - or the estimated aggregate cost during the twelve months following the first service performed or during the term of the contract, where this is greater than 12 months. 7. Where a proposed contract provides for options, the basis for calculating the contract value shall be the maximum permitted total including use of the option clauses. 8. The value of the thresholds in national currencies shall be revised every two years with effect from 1 January 1994. The calculation of these values shall be based on the average daily values of those currencies expressed in ecus over the 24 months terminating on the last day of August immediately preceding the 1 January revision. The values shall be published in the Official Journal of the European Communities at the beginning of November. The method of calculation referred to in the preceding subparagraph shall be examined, on the Commission's initiative, within the Advisory Committee for Public Contracts in principle two years after is initial application. TITLE II Two-tier application Article 8 Contracts which have as their object services listed in Annex I A shall be awarded in accordance with the provisions of Titles III to VI. Article 9 Contracts which have as their object services listed in Annex I B shall be awarded in accordance with Articles 14 and 16. Article 10 Contracts which have as their object services listed in both Annexes I A and I B shall be awarded in accordance with the provisions of Titles III to VI where the value of the services listed in Annex I A is greater than the value of the services listed in Annex I B. Where this is not the case, they shall be awarded in accordance with Articles 14 and 16. TITLE III Choice of award procedures and rules governing design contests Article 11 1. In awarding public service contracts, contracting authorities shall apply the procedures defined in Article 1 (d), (e) and (f), adapted for the purposes of this Directive. 2. Contracting authorities may award their public service contracts by negotiated procedure, with prior publication of a contract notice in the following cases: (a) in the event of irregular tenders in response to an open or restricted procedure or in the event of tenders which are unacceptable under national provisions that are in accordance with Articles 23 to 28, insofar as the original terms of the contract are not substantially altered. Contracting authorities may in such cases refrain from publishing a contract notice where they include in the negotiated procedure all the tenderers who satisfy the criteria of Articles 29 to 35 and who, during the prior open or restricted procedure, have submitted tenders in accordance with the formal requirements of the tendering procedure; (b) in exceptional cases, when the nature of the services or the risks involved do not permit prior overall pricing; (c) when the nature of the services to be procured, in particular in the case of intellectual services and services falling within category 6 of Annex I A, is such that contract specifications cannot be established with sufficient precision to permit the award of the contract by selecting the best tender according to the rules governing open or restricted procedures. 3. Contracting authorities may award public service contracts by negotiated procedure without prior publication of a contract notice in the following cases: (a) in the absence of tenders or of appropriate tenders in response to an open or restricted procedure provided that the original terms of the contract are not substantially altered and that a report is communicated to the Commission at its request; (b) when, for technical or artistic reasons, or for reasons connected with the protection of exclusive rights, the services may be provided only by a particular service provider; (c) where the contract concerned follows a design contest and must, under the rules applying, be awarded to the successful candidate or to one of the successful candidates. In the latter case, all successful candidates shall be invited to participate in the negotiations; (d) in so far as is strictly necessary when, for reasons of extreme urgency brought about by events unforeseeable by the contracting authorities in question, the time limit for the open, restricted or negotiated procedures referred to in Articles 17 to 20 cannot be kept. The circumstances invoked to justify extreme urgency must not in any event be attributable to the contracting authorities; (e) for additional services not included in the project initially considered or in the contract first concluded but which have, through unforeseen circumstances, become necessary for the performance of the service described therein, on condition that the award is made to the service provider carrying out such service: - when such additional services cannot be technically or economically separated from the main contract without great inconvenience to the contracting authorities, or - when such services, although separable from the performance of the original contract, are strictly necessary for its completion. However, the aggregate estimated value of contracts awarded for additional services may not exceed 50 % of the amount of the main contract; (f) for new services consisting in the repetition of similar services entrusted to the service provider to which the same contracting authorities awarded an earlier contract, provided that such services conform to a basic project for which a first contract was awarded according to the procedures referred to in paragraph 4. As soon as the first project is put up for tender, notice must be given that the negotiated procedure might be adopted and the total estimated cost of subsequent services shall be taken into consideration by the contracting authorities when they apply the provisions of Article 7. This procedure may be applied solely during the three years following the conclusion of the original contract. 4. In all other cases, the contracting authorities shall award their public service contracts by the open procedure or by the restricted procedure. Article 12 1. The contracting authority shall, within fifteen days of the date on which the request is received, inform any eliminated candidate or tenderer who so requests in writing of the reasons for rejection of his application or his tender, and, in the case of a tender, the name of the successful tenderer. 2. The contracting authority shall inform candidates or tenderers who so request in writing of the grounds on which it decided not to award a contract in respect of which a prior call for competition was made, or to recommence the procedure. It shall also inform the Office for Official Publications of the European Communities of that decision. 3. For each contract awarded, the contracting authorities shall draw up a written report which shall include at least the following: - the name and address of the contracting authority, the subject and value of the contract, - the names of the candidates or tenderers admitted and the reasons for their selection, - the names of the candidates or tenderers rejected and the reasons for their rejection, - the name of the successful tenderer and the reasons why his tender was selected and, if known, the part of the contract which the successful tenderer intends to subcontract to third parties, - for negotiated procedures, the circumstances referred to in Article 11 which justify the use of these procedures. This report, or the main features of it, shall be communicated to the Commission at its request. Article 13 1. This Article shall apply to design contests organized as part of a procedure leading to the award of a service contract whose estimated value net of VAT is not less than the value referred to in Article 7 (1). 2. This Article shall apply to all design contests where the total amount of contest prizes and payments to participants is not less than ECU 200000. 3. The rules for the organization of a design contest shall be in conformity with the requirements of this Article and shall be communicated to those interested in participating in the contest. 4. The admission of participants to design contests shall not be limited: - by reference to the territory or part of the territory of a Member State, - on the grounds that, under the law of the Member State in which the contest is organized, they would have been required to be either natural or legal persons. 5. Where design contests are restricted to a limited number of participants, the contracting authorities shall lay down clear and non-discriminatory selection criteria. In any event, the number of candidates invited to participate shall be sufficient to ensure genuine competition. 6. The jury shall be composed exclusively of natural persons who are independent of participants in the contest. Where a particular professional qualification is required from participants in a contest, at least a third of its members must have the same qualification or its equivalent. The jury shall be autonomous in its decisions or opinions. These shall be reached on the basis of projects submitted anonymously and solely on the grounds of the criteria indicated in the notice within the meaning of Article 15 (3). TITLE IV Common rules in the technical field Article 14 1. The technical specifications defined in Annex II shall be given in the general documents or the contractual documents relating to each contract. 2. Without prejudice to the legally binding national technical rules and insofar as these are compatible with Community law, such technical specifications shall be defined by the contracting authorities by reference to national standards implementing European standards or by reference to European technical approvals or by reference to common technical specifications. 3. A contracting authority may depart from paragraph 2 if: (a) the standards, European technical approvals or common technical specifications do not include any provisions for establishing conformity, or technical means do not exist for establishing satisfactorily the conformity of a product with these standards, European technical approvals or common technical specifications; (b) the application of paragraph 2 would prejudice the application of Council Directive 86/361/EEC of 24 July 1986 on the initial stage of the mutual recognition of type approval for telecommunications terminal equipment(8), or Council Decision 87/95/EEC of 22 December 1986 on standardization in the field of information technology and telecommunications(9) or other Community instruments in specific service or product areas; (c) these standards, European technical approvals or common technical specifications would oblige the contracting authority to use products or materials incompatible with equipment already in use or would entail disproportionate costs or disproportionate technical difficulties, but only as part of a clearly defined and recorded strategy with a view to the transition, with a given period, to European standards, European technical approvals or common technical specifications; (d) the project concerned is of a genuinely innovative nature for which use of existing European standards, European technical approvals or common technical specifications would not be appropriate. 4. Contracting authorities invoking paragraph 3 shall record, wherever possible, the reasons for doing so in the contract notice published in the Official Journal of the European Communities or in the contract documents and in all cases shall record these reasons in their internal documentation and shall supply such information on request to Member States and to the Commission. 5. In the absence of European standards or European technical approvals or common technical specifications, the technical specifications: (a) shall be defined by reference to the national technical specifications recognized as complying with the basic requirements listed in the Community directives on technical harmonization, in accordance with the procedures laid down in those directives, and in particular in accordance with the procedures laid down in Directive 89/106/EEC(10); (b) may be defined by reference to national technical specifications relating to design and method of calculation and execution of works and use of materials; (c) may be defined by reference to other documents. In this case, it is appropriate to make reference in order of preference to: (i) national standards implementing international standards accepted by the country of the contracting authority; (ii) other national standards and national technical approvals of the country of the contracting authority; (iii) any other standard. 6. Unless it is justified by the subject of the contract, Member States shall prohibit the introduction into the contractual clauses relating to a given contract of technical specifications which mention products of a specific make or source or of a particular process and which therefore favour or eliminate certain service providers. In particular, the indication of trade marks, patents, types, or of specific origin or production shall be prohibited. However, if such indication is accompanied by the words "or equivalent", it shall be authorized in cases where the contracting authorities are unable to give a description of the subject of the contract using specifications which are sufficiently precise and intelligible to all parties concerned. TITLE V Common advertising rules Article 15 1. Contracting authorities shall make known, by means of an indicative notice to be published as soon as possible after the beginning of their budgetary year, the intended total procurement in each of the service categories listed in Annex I A which they envisage awarding during the subsequent 12 months where the total estimated value, taking account of the provisions of Article 7, is not less than ECU 750000. 2. Contracting authorities who wish to award a public service contract by open, restricted or, under the conditions laid down in Article 11, negotiated procedure, shall make known their intention by means of a notice. 3. Contracting authorities who wish to carry out a design contest shall make known their intention by means of a notice. Article 16 1. Contracting authorities who have awarded a public contract or have held a design contest shall send a notice of the results of the results of the award procedure to the Office for Official Publication of the European Communities. 2. The notices shall be published: - in the case of public contracts for services listed in Annex I A, in accordance with Articles 17 to 20, - in the case of design contests, in accordance with Article 17. 3. In the case of public contracts for services listed in Annex I B, the contracting authorities shall indicate in the notice whether they agree on its publication. 4. The Commission shall draw up the rules for establishing regular reports on the basis of the notices referred to in paragraph 3, and for the publication of such reports in accordance with the procedure laid down in Article 40 (3). 5. Where the release of information on the contract award would impede law enforcement or otherwise be contrary to the public interest or would prejudice the legitimate commercial interests of a particular enterprise, public or private, or might prejudice fair competition between service providers, such information need not be published. Article 17 1. The notices shall be drawn up in accordance with the models set out in Annexes III and IV and shall specify the information requested in those models. The contracting authorities may not require any conditions other than those specified in Articles 31 and 32 when requesting information concerning the economic and technical standards which they require of service providers for their selection (section 13 of Annex III B, section 13 of Annex III C, and section 12 of Annex III D). 2. The contracting authorities shall send the notices as rapidly as possible and by the most appropriate channels to the Office for Official Publications of the European Communities. In the case of the accelerated procedure referred to in Article 20, the notice shall be sent by telex, telegram or fax. The notice referred to in Article 15 (1) shall be sent as soon as possible after the beginning of each budgetary year. The notice referred to in Article 16 (1) shall be sent at the latest forty-eight days after the award of the contract in question or the closure of the design contest in question. 3. The notices referred to in Articles 15 (1) and 16 (1) shall be published in full in the Official Journal of the European Communities and in the TED data bank in the official languages of the Communities, the text in the original language alone being authentic. 4. The notices referred to in Article 15 (2) and (3) shall be published in full in the Official Journal of the European Communities and in the TED data bank in their original language. A summary of the important elements of each notice shall be published in the official languages of the Communities, the text in the original language alone being authentic. 5. The Office for Official Publications of the European Communities shall publish the notices not later than 12 days after their dispatch. In the case of the accelerated procedure referred to in Article 20, this period shall be reduced to five days. 6. The notices shall not be published in the official journals or in the press of the country of the contracting authority before the date of dispatch to the Office for Official Publications of the European Communities; they shall mention that date. They shall not contain information other than that published in the Official Journal of the European Communities. 7. The contracting authorities must be able to supply proof of the date of dispatch. 8. The cost of publication of the notices in the Official Journal of the European Communities shall be borne by the Communities. The length of the notice shall not be greater than one page of the Official Journal, or approximately 650 words. Each edition of the Official Journal containing one or more notices shall reproduce the model notice or notices on which the published notice or notices are based. Article 18 1. In open procedures the time limit for the receipt of tenders shall be fixed by the contracting authorities at not less than 52 days from the date of dispatch of the notice. 2. The time limit for the receipt of tenders provided for in paragraph 1 may be reduced to 36 days where the contracting authorities have published the contract notice, drafted in accordance with the model in Annex III A provided for in Article 15 (1), in the Official Journal of the European Communities. 3. Provided that they have been requested in good time, the contract documents and supporting documents shall be sent to the service providers by the contracting authorities or competent departments within six days of receipt of their application. 4. Provided that it has been requested in good time, additional information relating to the contract documents shall be supplied by the contracting authorities not later than six days before the final date fixed for receipt of tenders. 5. Where the contract documents, supporting documents or additional information are too bulky to be supplied within the time limits laid down in paragraph 3 or 4 or where the tenders can be made only after a visit to the site or after on-the-spot inspection of the documents supporting the contract documents, the time limits laid down in paragraph 1 and 2 shall be extended accordingly. Article 19 1. In restricted procedures and negotiated procedures within the meaning of Article 11 (2), the time limit for receipt of requests to participate fixed by the contracting authorities shall be not less than 37 days from the date of dispatch of the notice. 2. The contracting authorities shall simultaneously and in writing invite the selected candidates to submit their tenders. The letter of invitation shall be accompanied by the contract documents and supporting documents. It shall include at least the following information: (a) where appropriate, the address of the service from which the contract documents and supporting documents can be requested and the final date for making such a request; also the amount and terms of payment of any sum to be paid for such documents; (b) the final date for receipt of tenders, the address to which they must be sent and the language or languages in which they must be drawn up; (c) a reference to the contract notice published; (d) an indication of any documents to be annexed, either to support the verifiable statements furnished by the candidate in accordance with Article 17 (1), or to supplement the information provided for in that Article under the same conditions as those laid down in Articles 31 and 32; (e) the criteria for the award of the contract if these are not given in the notice. 3. In restricted procedures, the time limit for receipt of tenders fixed by the contracting authorities may not be less than forty days from the date of dispatch of the written invitation. 4. The time limit for receipt of tenders laid down in paragraph 3 may be reduced to 26 days where the contracting authorities have published the contract notice, drafted according to the model in Annex III A provided for in Article 15 (1), in the Official Journal of the European Communities. 5. Requests to participate in procedures for the award of contracts may be made by letter, telegram, telex, fax or telephone. If by one of the last four, they must be confirmed by letter dispatched before the end of the period laid down in paragraph 1. 6. Provided it has been requested in good time, additional information relating to the contract documents must be supplied by the contracting authorities not later than six days before the final date fixed for the receipt of tenders. 7. Where tenders can be made only after a visit to the site or after on-the-spot inspection of the documents supporting the contract documents, the time limit laid down in paragraphs 3 and 4 shall be extended accordingly. Article 20 1. In cases where urgency renders impracticable the time limits laid down in Article 19, the contracting authorities may fix the following time limits: (a) a time limit for receipt of requests to participate which shall be not less than 15 days from the date of dispatch of the notice; (b) a time limit for the receipt of tenders which shall be not less than 10 days from the date of the invitation to tender. 2. Provided it has been requested in good time, additional information relating to the contract documents must be supplied by the contracting authorities not later than four days before the final date fixed for the receipt of tenders. 3. Requests for participation in contracts and invitations to tender must be made by the most rapid means of communication possible. When requests to participate are made by telegram, telex, fax or telephone, they must be confirmed by letter dispatched before the expiry of the time limit referred to in paragraph 1. Article 21 Contracting authorities may arrange for the publication in the Official Journal of the European Communities of notices announcing public service contracts which are not subject to the publication requirement laid down in this Directive. Article 22 The conditions for the drawing up, transmission, receipt, translation, collection and distribution of the notices referred to in Articles 15, 16 and 17 and of the statistical reports provided for in Articles 16 (4) and 39 and the nomenclature provided for in Annexes I A and B together with the reference in the notices to particular positions of the nomenclature within the categories of services listed in those Annexes may be modified in accordance with the procedure laid down in Article 40 (3). TITLE VI CHAPTER 1 Common rules on participation Article 23 Contracts shall be awarded on the basis of the criteria laid down in Chapter 3, taking into account Article 24, after the suitability of the service providers not excluded under Article 29 has been checked by the contracting authorities in accordance with the criteria referred to in Articles 31 and 32. Article 24 1. Where the criterion for the award of the contract is that of the economically most advantageous tender, contracting authorities may take account of variants which are submitted by a tenderer and meet the minimum specifications required by such contracting authorities. The contracting authorities shall state in the contract documents the minimum specifications to be respected by the variants and any specific requirements for their presentation. They shall indicate in the contract notice if variants are not authorized. Contracting authorities may not reject the submission of a variant on the sole grounds that it has been drawn up with technical specifications defined by reference to national standards transposing European standards, to European technical approvals or to common technical specifications referred to in Article 14 (2) or even by reference to national technical specifications referred to in Article 14 (5) (a) and (b). 2. Contracting authorities which have admitted variants pursuant to paragraph 1 may not reject a variant on the sole grounds that it would lead, if successful, to a supply contract rather than a public service contract within the meaning of this Directive. Article 25 In the contract documents, the contracting authority may ask the tenderer to indicate in his tender any share of the contract he may intend to subcontract to third parties. This indication shall be without prejudice to the question of the principal service provider's liability. Article 26 1. Tenders may be submitted by groups of service providers. These groups may not be required to assume a specific legal form in order to submit the tender; however, the group selected may be required to do so when it has been awarded the contract. 2. Candidates or tenderers who, under the law of the Member State in which they are established, are entitled to carry out the relevant service activity, shall not be rejected solely on the grounds that, under the law of the Member State in which the contract is awarded, they would have been required to be either natural or legal persons. 3. Legal persons may be required to indicate in the tender or the request for participation the names and relevant professional qualifications of the staff to be responsible for the performance of the service. Article 27 1. In restricted and negotiated procedures the contracting authorities shall, on the basis of information given relating to the service provider's position as well as to the information and formalities necessary for the evaluation of the minimum conditions of an economic and technical nature to be fulfilled by him, select from among the candidates with the qualifications required by Articles 29 to 35 those whom they will invite to submit a tender or to negotiate. 2. Where the contracting authorities award a contract by restricted procedure, they may prescribe the range within which the number of service providers which they intend to invite will fall. In this case the range shall be indicated in the contract notice. The range shall be determined in the light of the nature of the service to be provided. The range must number at least five service providers and may be up to twenty. In any event, the number of candidates invited to tender shall be sufficient to ensure genuine competition. 3. Where the contracting authorities award a contract by negotiated procedure as referred to in Article 11 (2), the number of candidates admitted to negotiate may not be less than three, provided that there is a sufficient number of suitable candidates. 4. Each Member State shall ensure that contracting authorities issue invitations without discrimination to those nationals of other Member States who satisfy the necessary requirements and under the same conditions as to its own nationals. Article 28 1. The contracting authority may state in the contract documents, or be obliged by a Member State to do so, the authority or authorities from which a tenderer may obtain the appropriate information on the obligations relating to the employment protection provisions and the working conditions which are in force in the Member State, region or locality in which the services are to be performed and which shall be applicable to the services provided on site during the performance of the contract. 2. The contracting authority which supplies the information referred to in paragraph 1 shall request the tenderers or those participating in the contract award procedure to indicate that they have taken account, when drawing up their tender, of the obligations relating to employment protection provisions and the working conditions which are in force in the place where the service is to be carried out. This shall be without prejudice to the application of the provisions of Article 37 concerning the examination of abnormally low tenders. CHAPTER 2 Criteria for qualitative selection Article 29 Any service provider may be excluded from participation in a contract who: (a) is bankrupt or is being wound up, whose affairs are being administered by the court, who has entered into an arrangement with creditors, who has suspended business activities or who is in any analogous situation arising from a similar procedure under national laws and regulations; (b) is the subject of proceedings for a declaration of bankruptcy, for an order for compulsory winding-up or administration by the court or for an arrangement with creditors or of any other similar proceedings under national laws or regulations; (c) has been convicted of an offence concerning his professional conduct by a judgement which has the force of res judicata; (d) has been guilty of grave professional misconduct proven by any means which the contracting authorities can justify; (e) has not fulfilled obligations relating to the payment of social security contributions in accordance with the legal provisions of the country in which he is established or with those of the country of the contracting authority; (f) has not fulfilled obligations relating to the payment of taxes in accordance with the legal provisions of the country of the contracting authority; (g) is guilty of serious misrepresentation in supplying or failing to supply the information that may be required under this Chapter. Where the contracting authority requires of the service provider proof that none of the cases quoted in (a), (b), (c), (e), or (f) applies to him, it shall accept as sufficient evidence: - for (a), (b) or (c), the production of an extract from the "judicial record" or, failing this, of an equivalent document issued by a competent judicial or administrative authority in the country of origin or in the country whence that person comes showing that these requirements have been met, - for (e) or (f), a certificate issued by the competent authority in the Member State concerned. Where the country concerned does not issue such documents or certificates, they may be replaced by a declaration on oath made by the person concerned before a judicial or administrative authority, a notary or a competent professional or trade body, in the country of origin or in the country whence that person comes. Member States shall, within the time limit referred to in Article 44, designate the authorities and bodies competent to issue such documents or certificates and shall forthwith inform the other Member States and the Commission thereof. Article 30 1. In so far as candidates for a public contract or tenderers have to possess a particular authorization or to be members of a particular organization in their home country in order to be able to perform the service concerned, the contracting authority may require them to prove that they hold such authorization or membership. 2. Any candidate or tenderer may be requested to prove his enrolment, as prescribed in his country of establishment, in one of the professional or trade registers or to provide a declaration or certificate as described in paragraph 3 below. 3. The relevant professional and trade registers or declarations or certificates are: - in Belgium, the "registre du commerce - Handelsregister" and the "ordres professionels - Beroepsorden", - in Denmark, the "Erhvervs- og Selskabstyrelsen", - in Germany, the "Handelsregister", the "Handwerksrolle" and the "Vereinsregister", - in Greece, the service provider may be asked to provide a declaration on the exercise of the profession concerned made on oath before a notary; in the cases provided for by existing national legislation, for the provision of research services as mentioned in Annex I A, the professional register "Μητρώο Μελετητών" ανδ "Μητρώο Γραφείων Μελετών", - in Spain, the "Registro Central de Empresas Consultoras y de Servicios del Ministerio de Economía y Hacienda", - in France, the "registre du commerce" and the "répertoire des métiers", - in Italy, the "Registro della Camera di commercio, industria, agricoltura e artigianato", the "Registro delle commissioni provinciali per l'artigianato" or the "Consiglio nazionale degli ordini professionali", - in Luxembourg, the "registre aux firmes" and the "rôle de la Chambre des métiers", - in the Netherlands, the "Handelsregister", - in Portugal, the "Registro nacional das Pessoas Colectivas", - in the United Kingdom and Ireland, the service provider may be requested to provide a certificate from the Registrar of Companies or the Registrar of Friendly Societies or, if he is not so certified, a certificate stating that the person concerned has declared on oath that he is engaged in the profession in question in the country in which he is established in a specific place under a given business name. Article 31 1. Proof of the service provider's financial and economic standing may, as a general rule, be furnished by one or more of the following references: (a) appropriate statements from banks or evidence of relevant professional risk indemnity insurance; (b) the presentation of the service provider's balance sheets or extracts therefrom, where publication of the balance sheets is required under company law in the country in which the service provider is established; (c) a statement of the undertaking's overall turnover and its turnover in respect of the services to which the contract relates for the previous three financial years. 2. The contracting authorities shall specify in the contract notice or in the invitation to tender which reference or references mentioned in paragraph 1 they have chosen and which other references are to be produced. 3. If, for any valid reason, the service provider is unable to provide the references requested by the contracting authority, he may prove his economic and financial standing by any other document which the contracting authority considers appropriate. Article 32 1. The ability of service providers to perform services may be evaluated in particular with regard to their skills, efficiency, experience and reliability. 2. Evidence of the service provider's technical capability may be furnished by one or more of the following means according to the nature, quantity and purpose of the services to be provided: (a) the service provider's educational and professional qualifications and/or those of the firm's managerial staff and, in particular, those of the person or persons responsible for providing the services; (b) a list of the principal services provided in the past three years, with the sums, dates and recipients, public or private, of the services provided; - where provided to contracting authorities, evidence to be in the form of certificates issued or countersigned by the competent authority, - where provided to private purchasers, delivery to be certified by the purchaser or, failing this, simply declared by the service provider to have been effected; (c) an indication of the technicians or technical bodies involved, whether or not belonging directly to the service provider, especially those responsible for quality control; (d) a statement of the service provider's average annual manpower and the number of managerial staff for the last three years; (e) a statement of the tool, plant or technical equipment available to the service provider for carrying out the services; (f) a description of the service provider's measures for ensuring quality and his study and research facilities; (g) where the services to be provided are complex or, exceptionally, are required for a special purpose, a check carried out by the contracting authority or on its behalf by a competent official body of the country in which the service provider is established, subject to that body's agreement, on the technical capacities of the service provider and, if necessary, on his study and research facilities and quality control measures; (h) an indication of the proportion of the contract which the service provider may intend to sub-contract. 3. The contracting authority shall specify, in the notice or in the invitation to tender, which references it wishes to receive. 4. The extent of the information referred to in Article 31 and in paragraphs 1, 2 and 3 of this Article must be confined to the subject of the contract; contracting authorities shall take into consideration the legitimate interests of the service providers as regards the protection of their technical or trade secrets. Article 33 Where contracting authorities require the production of certificates drawn up by independent bodies for attesting conformity of the service with certain quality assurance standards, they shall refer to quality assurance systems based on the relevant EN 29000 European standards series certified by bodies conforming to the EN 45000 European standards series. They shall recognize equivalent certificates from bodies established in other Member States. They shall also accept other evidence of equivalent quality assurance measures from service providers who have no access to such certificates, or no possibility of obtaining them within the relevant time limits. Article 34 Within the limits of Articles 29 to 32, contracting authorities may invite the service providers to supplement the certificates and documents submitted or to clarify them. Article 35 1. Member States who have official lists of recognized service providers must adapt them to the provisions of Articles 29 (a) to (d) and (g) and of Articles 30, 31 and 32. 2. Service providers registered in the official lists may, for each contract, submit to the contracting authority a certificate of registration issued by the competent authority. This certificate shall state the reference which enabled them to be registered in the list and the classification given in this list. 3. Certified registration in official lists of service providers by the competent bodies shall, for the contracting authorities of other Member States, constitute a presumption of suitability corresponding to the service provider's classification only as regards Article 29 (a) to (d) and (g), Article 30, Article 31 (b) and (c) and Article 32 (a). Information which can be deduced from registration in official lists may not be questioned. However, with regard to the payment of social security contributions, an additional certificate may be required of any registered service provider whenever a contract is offered. The contracting authorities of other Member States shall apply the above provisions only in favour of service providers established in the Member State holding the official list. 4. When registering service providers from other Member States in an official list, no proof or statement can be required in addition to those required of national service providers and, in any case, none in addition to those required in Articles 29 to 33. 5. Member States which have official lists shall be obliged to inform the other Member States of the address of the body to which applications for registration should be sent. CHAPTER 3 Criteria for the award of contracts Article 36 1. Without prejudice to national laws, regulations or administrative provisions on the remuneration of certain services, the criteria on which the contracting authority shall base the award of contracts may be: (a) where the award is made to the economically most advantageous tender, various criteria relating to the contract: for example, quality, technical merit, aesthetic and functional characteristics, technical assistance and after-sales service, delivery date, delivery period or period of completion, price; or (b) the lowest price only. 2. Where the contract is to be awarded to the economically most advantageous tender, the contracting authority shall state in the contract documents or in the tender notice the award criteria which it intends to apply, where possible in descending order of importance. Article 37 If, for a given contract, tenders appear to be abnormally low in relation to the service to be provided, the contracting authority shall, before it may reject those tenders, request in writing details of the constituent elements of the tender which it considers relevant and shall verify those constituent elements taking account of the explanations received. The contracting authority may take into consideration explanations which are justified on objective grounds including the economy of the method by which the service is provided, or the technical solutions chosen, or the exceptionally favourable conditions available to the tenderer for the provision of the service, or the originality of the service proposed by the tenderer. If the documents relating to the contract provide for its award at the lowest price tendered, the contracting authority must communicate to the Commission the rejection of tenders which it considers to be too low. TITLE VII Final provisions Article 38 The calculation of time limits shall be made in accordance with Council Regulation (EEC, Euratom) No 1182/71 of 3 June 1971 determining the rules applicable to periods, dates and time limits(11) Article 39 1. In order to permit assessment of the results of applying the Directive, Member States shall, by 31 October 1995 at the latest for the preceding year and thereafter by 31 October of every second year, forward to the Commission a statistical report on the service contracts awarded by contracting authorities. 2. This report shall detail at least the number and value of contracts awarded by each contracting authority or category of contracting authority above the threshold, subdivided as far as possible by procedure, category of service and the nationality of the service provider to whom the contract has been awarded and, in the case of negotiated procedures, subdivided in accordance with Article 11, listing the number and value of the contracts awarded to each Member State and to third countries. 3. The Commission shall determine in accordance with the procedure laid down in Article 40 (3) the nature of any statistical information which is required in accordance with this Directive. Article 40 1. The Commission shall be assisted by the Advisory Committee for Public Contracts set up by Decision 71/306/EEC. 2. As regards telecommunications services falling within category 5 of Annex I A, the Commission shall also be assisted by the Advisory Committee on Telecommunications Procurement set up by Directive 90/531/EEC. 3. Where reference is made to the procedure laid down in this paragraph, the representative of the Commission 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 shall have the right to 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. 4. The Committees mentioned in paragraphs 1 and 2 shall examine, on the initiative of the Commission or at the request of a Member State, any question relating to the application of the Directive. Article 41 Article 1 (1) of Council Directive 89/665/EEC of 21 December 1989 on the coordination of the laws, regulations and administrative provisions relating to the application of review procedures to the award of public supply and public works contracts(12) shall be replaced by the following: "1. The Member States shall take the measures necessary to ensure that, as regards contract award procedures falling within the scope of Directives 71/305/EEC, 77/62/EE, and 92/50/EEC (+), decisions taken by the contracting authorities may be reviewed effectively and, in particular, as rapidly as possible in accordance with the conditions set out in the following Articles and, in particular, Article 2 (7) on the grounds that such decisions have infringed Community law in the field of public procurement or nation rules implementing that law. (*) OJ No L 209, 24. 7. 1992, p. 1." Article 42 1. Article 5 (1) (c) of Directive 77/62/EEC shall be replaced by the following: "(c) the value of the thresholds in national currencies and the threshold of the GATT Agreement expressed in ecus shall in principle be revised every two years with effect from 1 January 1988. The calculation of these values shall be based on the average daily values of these currencies expressed in ecus and of the ecu expressed in SDRs over the 24 months terminating on the last day of August immediately preceding the 1 January revision. These values shall be published in the Official Journal of the European Communities at the beginning of November." 2. Article 4a (2) of Directive 71/305/EEC shall be replaced by the following: "2. (a) The value of the threshold in national currencies shall normally be revised every two years with effect from 1 January 1992. The calculation of this value shall be based on the average daily values of these currencies expressed in ecus over the 24 months terminating on the last day of August immediately preceding the 1 January revision. These values shall be published in the Official Journal of the European Communities at the beginning of November. (b) The method of calculation laid down in subparagraph (a) shall be reviewed, on a proposal from the Commission, by the Advisory Committee for Public Contracts in principle two years after its initial application." Article 43 Not later than three years after the time limit for compliance with this Directive, the Commission, acting in close cooperation with the Committees referred to in Article 40 (1) and (2), shall review the man in which this Directive has operated, including the effects of the application of the Directive to procurement of the services listed in Annex I A and the provisions concerning technical standards. It shall evaluate, in particular, the prospects for the full application of the Directive to procurement of the other services listed in Annex I B, and the effects of in-house performance of services on the effective opening-up of procurement in this area. It shall make the necessary proposals to adapt the Directive accordingly. Article 44 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1993. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 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 45 This Directive is addressed to the Member States.

31992L0051

1992

Council Directive 92/51/EEC of 18 June 1992 on a second general system for the recognition of professional education and training to supplement Directive 89/48/EEC Having regard to the Treaty establishing the European Economic Community, particular Articles 49, 57 (1) and 66 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), (1) Whereas, pursuant to Article 8a of the Treaty, the internal market shall comprise an area without internal frontiers and whereas, pursuant to Article 3 (c) of the Treaty, the abolition, as between Member States, of obstacles to freedom of movement for persons and services constitutes one of the objectives of the Community; whereas, for nationals of the Member States, this means in particular the possibility of pursuing a profession, whether in a self-employed or employed capacity, in a Member State other than that in which they acquired their professional qualifications; (2) Whereas, for those professions for the pursuit of which the Community has not laid down the necessary minimum level of qualification, Member States reserve the option of fixing such a level with a view to guaranteeing the quality of services provided in their territory; whereas, however, they may not, without disregarding their obligations laid down in Articles 5, 48, 52 and 59 of the Treaty, require a national of a Member State to obtain those qualifications which in general they determine only by reference to those issued under their own national education and training systems, where the person concerned has already acquired all or part of those qualifications in another Member State; whereas, as a result, any host Member State in which a profession is regulated is required to take account of qualifications acquired in another Member State and to determine whether those qualifications correspond to the qualifications which the Member State concerned requires; (3) Whereas Council Directive 89/48/EEC of 21 December 1988 on a general system for the recognition of higher education diplomas awarded on completion of professional education and training of at least three years' duration (4) facilitates compliance with such obligations; whereas, however, it is limited to higher education; (4) Whereas, in order to facilitate the pursuit of all those professional activities which in a host Member State are dependent on the completion of a certain level of education and training, a second general system should be introduced to complement the first; (5) Whereas the complementary general system must be based on the same principles and contain mutatis mutandis the same rules as the initial general system; (6) Whereas this Directive is not applicable to those regulated professions which are covered by specific Directives principally concerned with introducing mutual recognition of training courses completed before entry into professional life; (7) Whereas neither is it applicable, furthermore, to those activities covered by specific Directives principally intended to introduce recognition of technical skills based on experience acquired in another Member State; whereas certain of those Directives apply solely to the pursuit of activities in a self-employed capacity; whereas, in order to ensure that the pursuit of such activities as an employed person does not fall within the scope of this Directive, whereby the pursuit of the same activity would be subject to different legal recognition arrangements depending on whether it was pursued in a self-employed capacity or as an employed person, those Directives should be made applicable to persons pursuing the activities in question as employed persons; (8) Whereas the complementary general system is entirely without prejudice to the application of Article 48 (4) and Article 55 of the Treaty; (9) Whereas this complementary system must cover the levels of education and training not covered by the initial general system, namely that corresponding to other post-secondary education and training courses and other equivalent education and training, and that corresponding to long or short secondary courses, possibly complemented by professional training or experience; (10) Whereas, where in most Member States pursuit of a given regulated profession is subject to either very short training or the possession of certain personal attributes or merely general knowledge, the normal mechanisms for recognition under this Directive may be excessively cumbersome; whereas in such cases there should be provision for simplified mechanisms; (11) Whereas account should also be taken of the professional training system in the United Kingdom whereby standards for levels of performance for all professional activities are established via the 'National Framework of Vocational Qualifications'; (12) Whereas in some Member States there are only relatively few regulated professions; whereas, however, training for professions which are not regulated may be specifically geared to the pursuit of the profession, with the structure and level of training being monitored or approved by the competent authorities of the Member State concerned; whereas this provides guarantees equivalent to those provided in connection with a regulated profession; (13) Whereas the competent authorities of the host Member State should be allowed to determine, in accordance with the relevant provisions of Community law, the detailed rules necessary for implementation of the adaptation period and the aptitude test; (14) Whereas, since it covers two levels of education and training and since the initial general system covers a third level, the complementary general system must lay down whether and under what conditions a person possessing a certain level of education and training may pursue, in another Member State, a profession the qualifications for which are regulated at a different level; (15) Whereas, for the pursuit of certain professions, certain Member States require the possession of a diploma within the meaning of Directive 89/48/EEC, while for the same profession other Member States require the completion of professional education or training with a different structure; whereas certain kinds of education and training, while not of a post-secondary nature of minimum duration within the meaning of this Directive, nevertheless result in a comparable professional level and prepare the person for similar responsibilities and activities; whereas such education and training should therefore be classed in the same category as that attested by a diploma; whereas such education and training is very varied and this classification can be achieved only by listing the courses in question; whereas such classification would, where appropriate, establish the recognition of equivalence between such education and training and that covered by Directive 89/48/EEC; whereas some regulated education and training should also be classed at diploma level in a second list; (16) Whereas, in view of the constantly changing organization of professional training, there should be a procedure for amending those lists; (17) Whereas, since it covers occupations the pursuit of which is dependent on the possession of professional or vocational education and training qualifications of secondary level and generally requires manual skills, the complementary general system must also provide for the recognition of such qualifications even where they have been acquired solely through professional experience in a Member State which does not regulate such professions; (18) Whereas the aim of this general system, like the first general system, is to eliminate obstacles to the taking up and pursuit of regulated professions; whereas work carried out pursuant to Council Decision 85/368/EEC of 16 July 1985 on the comparability of vocational training qualifications between the Member States of the European Community (5), while pursuing a different objective from the elimination of legal obstacles to freedom of movement, namely that of improving the transparency of the labour market, must be used, where appropriate, in the application of this Directive, particularly where it could provide information on the subject, content and duration of professional training; (19) Whereas professional bodies and professional educational and training establishments should, where appropriate, be consulted or be involved in an appropriate way in the decision-making process; (20) Whereas, like the initial system, such a system, by strengthening the right of a Community national to use his occupational skills in any Member State, supplements and reinforces his right to acquire such skills wherever he wishes; (21) Whereas the two systems should be evaluated, after a certain period of application, in order to determine how efficiently they operate and, in particular, how they can both be improved, CHAPTER I Definitions Article 1 For the purposes of this Directive, the following definitions shall apply: (a) diploma: any evidence of education and training or any set of such evidence: - which has been awarded by a competent authority in a Member State, designated in accordance with the laws, regulations or administrative provisions of that State, - which shows that the holder has successfully completed: (i) either a post-secondary course other than that referred to in the second indent of Article 1 (a) of Directive 89/48/EEC, of at least one year's duration or of equivalent duration on a part-time basis, one of the conditions of entry of which is, as a general rule, the successful completion of the secondary course required to obtain entry to university or higher education, as well as the professional training which may be required in addition to that post-secondary course; (ii) or one of the education and training courses in Annex C, and - which shows that the holder has the professional qualifications required for the taking up or pursuit of a regulated profession in that Member State, provided that the education and training attested by this evidence was received mainly in the Community, or outside the Community at teaching establishments which provide education and training in accordance with the laws, regulations or administrative provisions of a Member State, or that the holder thereof has three years' professional experience certified by the Member State which recognized third-country evidence of education and training. The following shall be treated in the same way as a diploma within the meaning of the first subparagraph: any evidence of education and training or any set of such evidence awarded by a competent authority in a Member State if it is awarded on the successful completion of education and training received in the Community and recognized by a competent authority in that member State as being of an equivalent level and if it confers the same rights in respect of the taking up and pursuit of a regulated profession in that Member State; (b) certificate: any evidence of education and training or any set of such evidence: - which has been awarded by a competent authority in a Member State, designated in accordance with the laws, regulations or administrative provisions of that State, - which shows that the holder, after having followed a secondary course, has completed: either a course of education or training other than courses referred to in point (a), provided at an educational or training establishment or on the job, or in combination at an educational or training establishment and on the job, and complemented, where appropriate, by the probationary or professional practice required in addition to this course, or the probationary or professional practice required in addition to this secondary course, or - which shows that the holder, after having followed a secondary course of a technical or vocational nature has completed, where necessary, either a course of education or training as referred to in the previous indent, or the probationary or professional practice required in addition to this secondary course of a technical or vocational nature and - which shows that the holder has the professional qualifications required for the taking up or pursuit of a regulated profession in that Member State, provided that the education and training attested by this evidence was received mainly in the Community, or outside the Community at teaching establishments which provide education and training in accordance with the laws, regulations or administrative provisions of a Member State, or that the holder thereof has two years' professional experience certified by the Member State which recognized third-country evidence of education and training. The following shall be treated in the same was as a certificate, within the meaning of the first subparagraph: any evidence of education and training or any set of such evidence awarded by a competent authority in a Member State if it is awarded on the successful completion of education and training received in the Community and recognized by a competent authority in a Member State as being of an equivalent level and if it confers the same rights in respect of the taking up and pursuit of a regulated profession in that Member State; (c) attestation of competence: any evidence of qualifications: - attesting to education and training not forming part of a set constituting a diploma within the meaning of Directive 89/48/EEC or a diploma or certificate within the meaning of this Directive, or - awarded following an assessment of the personal qualities, aptitudes or knowledge which it is considered essential that the applicant have for the pursuit of a profession by an authority designated in accordance with the laws, regulations or administrative provisions of a Member State, without proof of prior education and training being required; (d) host Member State: any Member State in which a national of a Member State applies to pursue a profession subject to regulation in that Member State, other than the State in which he obtained his evidence of education and training or attestation of competence or first pursued the profession in question; (e) regulated profession: the regulated professional activity or range of activities which constitute this profession in a Member State; (f) regulated professional activity: a professional activity the taking up or pursuit of which, or one of its modes of pursuit in a Member State, is subject, directly or indirectly, by virtue of laws, regulations or administrative provisions, to the possession of evidence of education and training or an attestation of competence. The following in particular shall constitute a mode of pursuit of a regulated professional activity: - pursuit of an activity under a professional title, in so far as the use of such a title is reserved to the holders of evidence of education and training or an attestation of competence governed by laws, regulations or administrative provisions, - pursuit of a professional activity relating to health, in so far as remuneration and/or reimbursement for such an activity is subject by virtue of national social security arrangements to the possession of evidence of education and training or an attestation of competence. Where the first subparagraph does not apply, a professional activity shall be deemed to be a regulated professional activity if it is pursued by the members of an association or organization the purpose of which is, in particular, to promote and maintain a high standard in the professional field concerned and which, to achieve that purpose, is recognized in a special form by a Member State and: - awards evidence of education and training to its members, - ensures that its members respect the rules of professional conduct which it prescribes, and - confers on them the right to use a professional title or designatory letters, or to benefit from a status corresponding to that education and training. Whenever a Member State grants the recognition referred to in the second subparagraph to an association or organization which satisfies the conditions of that subparagraph, it shall inform the Commission thereof; (g) regulated education and training: any education and training which: - is specifically geared to the pursuit of a given profession, and - comprises a course or courses complemented, where appropriate, by professional training or probationary or professional practice, the structure and level of which are determined by the laws, regulations or administrative provisions of that Member State or which are monitored or approved by the authority designated for that purpose; (h) professional experience: the actual and lawful pursuit of the profession concerned in a Member State; (i) adaptation period: the pursuit of a regulated profession in the host Member State under the responsibility of a qualified member of that profession, such period of supervised practice possibly being accompanied by further education and training. This period of supervised practice shall be the subject of an assessment. The detailed rules governing the adaptation period and its assessment shall be laid down by the competent authorities in the host Member State. The status enjoyed in the host Member State by the person undergoing the period of supervised practice, in particular in the matter of right of residence as well as of obligations, social rights and benefits, allowances and remuneration, shall be established by the competent authorities in that Member State in accordance with applicable Community law; (j) aptitude test: a test limited to the professional knowledge of the applicant, made by the competent authorities of the host Member State with the aim of assessing the ability of the applicant to pursue a regulated profession in that Member State. In order to permit this test to be carried out, the competent authorities shall draw up a list of subjects which, on the basis of a comparison of the education and training required in the Member State and that received by the applicant, are not covered by the evidence of education and training possessed by the applicant. These subjects may cover both theoretical knowledge and practical skills required for the pursuit of the profession. This aptitude test must take account of the fact that the applicant is a qualified professional in the Member State of origin or the Member State from which he comes. It shall cover subjects to be selected from those on the list referred to in the second subparagraph, knowledge of which is essential to the pursuit of the profession in the host Member State. The test may also include knowledge of the professional rules applicable to the activities in question in the host Member State. The detailed application of the aptitude test shall be determined by the competent authorities of that State. The status in the host Member State of the applicant who wishes to prepare himself for the aptitude test in that State shall be determined by the competent authorities in that State, in accordance with applicable Community law. CHAPTER II Scope Article 2 This Directive shall apply to any national of a Member State wishing to pursue a regulated profession in a host Member State in a self-employed capacity or as an employed person. This Directive shall apply to neither professions which are the subject of a specific Directive establishing arrangements for the mutual recognition of diplomas by Member States, nor activities covered by a Directive listed in Annex A. The Directives listed in Annex B shall be made applicable to the pursuit as an employed person of the activities covered by those Directives. CHAPTER III System for recognition where a host Member State requires possession of a diploma within the meaning of this Directive or Directive 89/48/EEC Article 3 Without prejudice to Directive 89/48/EEC, where, in a host Member State, the taking up or pursuit of a regulated profession is subject to possession of a diploma, as defined in this Directive or in Directive 89/48/EEC, the competent authority may not, on the grounds of inadequate qualifications, refuse to authorize a national of a Member State to take up or pursue that profession on the same conditions as those which apply to its own nationals: (a) if the applicant holds the diploma, as defined in this Directive or in Directive 89/48/EEC, required in another Member State for the taking up or pursuit of the profession in question in its territory, such diploma having been awarded in a Member State; or (b) if the applicant has pursued the profession in question full-time for two years, or for an equivalent period on a part-time basis, during the previous 10 years in another Member State which does not regulate that profession within the meaning of either Article 1 (e) and the first subparagraph of Article 1 (f) of this Directive or Article 1 (c) and the first subparagraph of Article 1 (d) of Directive 89/48/EEC, and possesses evidence of education and training which: - has been awarded by a competent authority in a Member State, designated in accordance with the laws, regulations or administrative provisions of that State, and - either shows that the holder has successfully completed a post-secondary course, other than that referred to in the second indent of Article 1 (a) of Directive 89/48/EEC, of at least one year's duration, or of equivalent duration on a part-time basis, one of the conditions of entry of which is, as a general rule, the successful completion of the secondary course required to obtain entry to university or higher education, as well as any professional training which is an integral part of that post-secondary course, - or attests to regulated education and training referred to in Annex D, and - has prepared the holder for the pursuit of his profession. However, the two years' professional experience referred to above may not be required where the evidence of education and training held by the applicant and referred to in this point is awarded on completion of regulated education and training. The following shall be treated in the same way as the evidence of education and training referred to in the first subparagraph of this point: any evidence of education and training or any set of such evidence awarded by a competent authority in a Member State if it is awarded on the completion of education and training received in the Community and is recognized by that Member State as being of an equivalent level, provided that the other Member States and the Commission have been notified of this recognition. By way of derogation from the first subparagraph of this Article, the host Member State is not required to apply this Article where the taking up or pursuit of a regulated profession is subject in its country to possession of a diploma as defined in Directive 89/48/EEC, one of the conditions for the issue of which shall be the completion of a post-secondary course of more than four years duration. Article 4 1. Notwithstanding Article 3, the host Member State may also require the applicant: (a) to provide evidence of professional experience, where the duration of the education and training adduced in support of his application, as laid down in points (a) and (b) of the first subparagraph of Article 3, is at least one year less than that required in the host Member State. In this event, the period of professional experience required may not exceed: - twice the shortfall in duration of education and training where the shortfall relates to a post-secondary course and/or to a period of probationary practice carried out under the control of a supervising professional person and ending with an examination, - the shortfall where the shortfall relates to professional practice acquired with the assistance of a qualified member of the profession concerned. In the case of diplomas within the meaning of the second subparagraph of Article 1 (a), the duration of education and training recognized as being of an equivalent level shall be determined as for the education and training defined in the first subparagraph of Article 1 (a). When these provisions are applied, account must be taken of the professional experience referred to in point (b) of the first subparagraph of Article 3. In any event, the professional experience required may not exceed four years. Professional experience may not, however, be required of an applicant holding a diploma attesting to a post-secondary course as referred to in the second indent of Article 1 (a) or a diploma as defined in Article 1 (a) of Directive 89/48/EEC who wishes to pursue his profession in a host Member State which requires the possession of a diploma or evidence of education and training attesting to one of the courses of education and training as referred to in Annexes C and D; (b) to complete an adaptation period not exceeding three years or take an aptitude test where: - the theoretical and/or practical matters covered by the education and training which he has received as laid down in points (a) or (b) of the first subparagraph of Article 3 differ substantially from those covered by the diploma, as defined in this Directive or in Directive 89/48/EEC, required in the host Member State, or - in the case referred to in point (a) of the first subparagraph of Article 3, the profession regulated in the host Member State comprises one or more regulated professional activities which do not form part of the profession regulated in the Member State from which the applicant originates or comes and that difference corresponds to specific education and training required in the host Member State and covers theoretical and/or practical matters which differ substantially from those covered by the diploma, as defined in this Directive or in Directive 89/48/EEC, adduced by the applicant, or - in the case referred to in point (b) of the first subparagraph of Article 3, the profession regulated in the host Member State comprises one or more regulated professional activities which do not form part of the profession pursued by the applicant in the Member State from which he originates or comes, and that difference corresponds to specific education and training required in the host Member State and covers theoretical and/or practical matters which differ substantially from those covered by the evidence of education and training adduced by the applicant. Should the host Member State make use of this possibility, it must give the applicant the right to choose between an adaptation period and an aptitude test. Where the host Member State, which requires a diploma as defined in Directive 89/48/EEC or in this Directive, intends to introduce derogations from an applicant's right to choose, the procedure laid down in Article 14 shall apply. By way of derogation from the second subparagraph of this point, the host Member State may reserve the right to choose between the adaptation period and the aptitude test if - a profession is involved the pursuit of which requires a precise knowledge of national law and in respect of which the provision of advice and/or assistance concerning national law is an essential and constant feature of the professional activity, or - where the host Member State makes access to the profession or its pursuit subject to the possession of a diploma as defined in Directive 89/48/EEC, one of the conditions for the award of which is the completion of a post-secondary course of at least three years' duration or an equivalent period on a part-time basis and the applicant holds either a diploma as defined in this Directive or evidence of education and training within the meaning of point (b) of the first subparagraph of Article 3 and not covered by Article 3 (b) of Directive 89/48/EEC. 2. However, the host Member State may not apply the provisions of paragraph 1 (a) and (b) cumulatively. CHAPTER IV System for recognition where a host Member State requires possession of a diploma and the applicant is the holder of a certificate or has received corresponding education and training Article 5 Where, in a host Member State, the taking up or pursuit of a regulated profession is subject to possession of a diploma, the competent authority may not, on the grounds of inadequate qualifications, refuse to authorize a national of a Member State to take up or pursue that profession on the same conditions as those which apply to its own nationals: (a) if the applicant holds the certificate required in another Member State for the taking up or pursuit of the same profession in its territory, such certificate having been awarded in a Member State; or (b) if the applicant has pursued the same profession full-time for two years during the previous 10 years in another Member State which does not regulate that profession, within the meaning of Article 1 (e) and the first subparagraph of Article 1 (f), and possesses evidence of education and training: - which was been awarded by a competent authority in a Member State, designated in accordance with the laws, regulations or administrative provisions of that State, and - which shows that the holder, after having followed a secondary course, has completed: either a course of professional education or training other than courses referred to in point (a), provided at an educational or training establishment or on the job, or in combination at an educational or training establishment and on the job and complemented, where appropriate, by the probationary or professional practice which is an integral part of that training course, or the probationary or professional practice which is an integral part of that secondary course, or - which shows that the holder, after having followed a secondary course of a technical or vocational nature has completed, where necessary, either a course of professional education or training as referred to in the previous indent, or the period of probationary or professional practice which is an integral part of that secondary course of a technical or vocational nature and - which has prepared the holder for the pursuit of this profession. However, the two years' professional experience referred to above may not be required where the evidence of education and training held by the applicant and referred to in this point is awarded on completion of regulated education and training. Nevertheless, the host Member State may require the applicant to undergo an adaptation period not exceeding three years or take an aptitude test. The host Member State must give the applicant the right to choose between an adaptation period and an aptitude test. Where the host Member State intends to introduce derogations from an applicant's right to choose, the procedure laid down in Article 14 shall apply. CHAPTER V System for recognition where a host Member State requires possession of a certificate Article 6 Where, in the host Member State, the taking up or pursuit of a regulated profession is subject to possession of a certificate, the competent authority may not, on the grounds of inadequate qualifications, refuse to authorize a national of a Member State to take up or pursue that profession on the same conditions as those which apply to its own nationals: (a) if the applicant holds the diploma, as defined in this Directive or in Directive 89/48/EEC, or the certificate required in another Member State for the taking up or pursuit of the profession in question in its territory, such diploma having been awarded in a Member State; or (b) if the applicant has pursued the profession in question full-time for two years or for an equivalent period on a part-time basis during the previous 10 years in another Member State which does not regulate that profession, within the meaning of Article 1 (e) and the first subparagraph of Article 1 (f), and possesses evidence of education and training: - which has been awarded by a competent authority in a Member State, designated in accordance with the laws, regulations or administrative provisions of that State, and - which shows that the holder has successfully completed a post-secondary course other than that referred to in the second indent of Article 1 (a) of Directive 89/48/EEC, of at least one year's duration or of equivalent duration on a part-time basis, one of the conditions of entry of which is, as a general rule, the completion of the secondary course required to obtain entry to university or higher education, as well as any professional training which is an integral part of that post-secondary course, or - which shows that the holder, after having followed a secondary course, has completed: either a course of education or training for a profession other than courses referred to in point (a), provided at an educational establishment or on the job, or in combination at an educational establishment and on the job and complemented, where appropriate, by the probationary or professional practice which is an integral part of that training course, or the probationary or professional practice which is an integral part of that secondary course, or - which shows that the holder, after having followed a secondary course of a technical or vocational nature has completed, where necessary, either a course of education or training for a profession as referred to in the previous indent, or the period of probationary or professional practice which is an integral part of that secondary course of a technical or vocational nature and - which has prepared the holder for the pursuit of this profession. However, the two years' professional experience referred to above may not be required where the evidence of education and training held by the applicant and referred to in this point is awarded on completion or regulated education and training. (c) if the applicant who does not hold any diploma, certificate or other evidence of education and training within the meaning of Article 3 (b) or of point (b) of this Article has pursued the profession in question full-time for three consecutive years, or for an equivalent period on a part-time basis, during the previous 10 years in another Member State which does not regulate that profession within the meaning of Article 1 (e) and the first subparagraph of Article 1 (f). The following shall be treated in the same way as the evidence of education and training referred to under (b) in the first subparagraph: any evidence of education and training or any set of such evidence awarded by a competent authority in a Member State if it is awarded on the completion of education and training received in the Community and is recognized by that Member State as being of an equivalent level, provided that the other Member States and the Commission have been notified of this recognition. Article 7 Without prejudice to Article 6, a host Member State may also require the applicant to: (a) complete an adaptation period not exceeding two years or to take an aptitude test when the education and training which he received in accordance with points (a) or (b) of the first subparagraph of Article 5 relates to theoretical or practical matters differing substantially from those covered by the certificate required in the host Member State, or where there are differences in the fields of activity characterized in the host Member State by specific education and training relating to theoretical or practical matters differing substantially from those covered by the applicant's evidence of formal qualifications. Should the host Member State make use of this possibility, it must give the applicant the right to choose between an adaptation period and an aptitude test. Where the host Member State which requires a certificate intends to introduce derogations as regards an applicant's right to choose, the procedure laid down in Article 14 shall apply; (b) undergo an adaptation period not exceeding two years or take an aptitude test where, in the instance referred to in point (c) of the first subparagraph of Article 6, he does not hold a diploma, certificate or other evidence of education and training. The host Member State may reserve the right to choose between an adaptation period and an aptitude test. CHAPTER VI Special systems for recognition of other qualifications Article 8 Where, in the host Member State, the taking up or pursuit of a regulated profession is subject to possession of an attestation of competence, the competent authority may not, on the grounds of inadequate qualifications, refuse to authorize a national of a Member State to take up or pursue that profession on the same conditions as those which apply to its own nationals: (a) if the applicant holds the attestation of competence required in another Member State for the taking up or pursuit of the same profession in its territory, such attestation having been awarded in a Member State; or (b) if the applicant provides proof of qualifications obtained in other Member States, and giving guarantees, in particular in the matter of health, safety, environmental protection and consumer protection, equivalent to those required by the laws, regulations or administrative provisions of the host Member State. If the applicant does not provide proof of such an attestation or of such qualifications the laws, regulations or administrative provisions of the host Member State shall apply. Article 9 Where, in the host Member State, the taking up or pursuit of a regulated profession is subject only to possession of evidence of education attesting to general education at primary or secondary school level, the competent authority may not, on the grounds of inadequate qualifications, refuse to authorize a national of a Member State to take up or pursue that profession on the same conditions as those which apply to its own nationals if the applicant possesses formal qualifications of the corresponding level, awarded in another Member State. This evidence of formal qualifications must have been awarded by a competent authority in that Member State, designated in accordance with its own laws, regulations or administrative provisions. CHAPTER VII Other measures to facilitate the effective exercise of the right of establishment, freedom to provide services and freedom of movement of employed persons Article 10 1. Where the competent authority of the host Member State requires of persons wishing to take up a regulated profession proof that they are of good character or repute or that they have not been declared bankrupt, or suspends or prohibits the pursuit of that profession in the event of serious professional misconduct or a criminal offence, that State shall accept as sufficient evidence, in respect of nationals of Member States wishing to pursue that profession in its territory, the production of documents issued by competent authorities in the Member State of origin or the Member State from which the foreign national comes showing that those requirements are met. Where the competent authorities of the Member State of origin or of the Member State from which the foreign national comes do not issue the documents referred to in the first subparagraph, such documents shall be replaced by a declaration on oath - or, in Member States where there is no provision for declaration on oath, by a solemn declaration - made by the person concerned before a competent judicial or administrative authority or, where appropriate, a notary or qualified professional body of the Member State of origin or the Member State from which the person comes; such authority or notary shall issue written confirmation attesting the authenticity of the declaration on oath or solemn declaration. 2. Where the competent authority of the host Member State requires of nationals of that Member State wishing to take up or pursue a regulated profession a statement of physical of mental health, that authority shall accept as sufficient evidence in this respect the production of the document required in the Member State of origin or the Member State from which the foreign national comes. Where the Member State of origin or the Member State from which the foreign national comes does not impose any requirements of this nature on those wishing to take up or pursue the profession in question, the host Member State shall accept from such nationals a statement issued by a competent authority in that State corresponding to the statement issued in the host Member State. 3. The competent authority of the host Member State may require that the documents and statements referred to in paragraphs 1 and 2 are presented no more than three months after their date of issue. 4. Where the competent authority of the host Member State requires nationals of that Member State wishing to take up or pursue a regulated profession to take an oath or make solemn declaration and where the form of such oath or declaration cannot be used by nationals of other Member States, that authority shall ensure that an appropriate and equivalent form of oath or declaration is offered to the person concerned. Article 11 1. The competent authorities of host Member States shall recognize the right of nationals of Member States who fulfil the conditions for the taking up and pursuit of a regulated profession in their territory to use the professional title of the host Member State corresponding to that profession. 2. The competent authority of the host Member State shall recognize the right of nationals of Member States who fulfil the conditions for the taking up and pursuit of a regulated profession in the territory to use their lawful academic title and, where appropriate, the abbreviation thereof deriving from their Member State of origin or the Member State from which they come, in the language of that State. The host Member State may require this title to be followed by the name and location of the establishment or examining board which awarded it. 3. Where a profession is regulated in the host Member State by an association or organization referred to in Article 1 (f), nationals of Member States shall be entitled to use the professional title or designatory letters conferred by that organization or association only on proof of membership. Where the association or organization makes membership subject to certain qualification requirements, it may apply these to nationals of other Member States who are in possession of a diploma within the meaning of Article 1 (a), a certificate within the meaning of Article 1 (b) or evidence of education and training or qualification within the meaning of point (b) of the first subparagraph of Article 3, point (b) of the first subparagraph of Article 5 or Article 9 in accordance only with this Directive, in particular Articles 3, 4 and 5. Article 12 1. The host Member State shall accept as means of proof that the conditions laid down in Articles 3 to 9 are satisfied the documents issued by the competent authorities in the Member States, which the person concerned shall submit in support of his application to pursue the profession concerned. 2. The procedure for examining an application to pursue a regulated profession shall be completed as soon as possible and the outcome communicated in a reasoned decision of the competent authority in the host Member State not later than four months after presentation of all the documents relating to the person concerned. A remedy shall be available against this decision or the absence thereof, before a court or tribunal in accordance with the provisions of national law. CHAPTER VIII Procedure for coordination Article 13 1. Member States shall designate, within the period provided for in Article 17, the competent authorities empowered to receive the applications and take the decisions referred to in this Directive. They shall communicate this information to the other Member States and to the Commission. 2. Each Member State shall designate a person responsible for coordinating the activities of the authorities referred to in paragraph 1 and shall inform the other Member States and the Commission to that effect. His role shall be to promote uniform application of this Directive to all the professions concerned. This coordinator shall be a member of the coordinating group set up under the aegis of the Commission by Article 9 (2) of Directive 89/48/EEC. The coordinating group set up under the aforementioned provision of Directive 89/48/EEC shall also be required to: - facilitate the implementation of this Directive, - collect all useful information for its application in the Member States, particularly information relating to the establishment of an indicative list of regulated professions and to the disparities between the qualifications awarded in the Member States with a view to assisting the competent authorities of the Member States in their task of assessing whether substantial differences exist. The group may be consulted by the Commission on any changes to the existing system which may be contemplated. 3. The Member States shall take measures to provide the necessary information on the recognition of diplomas and certificates and on other conditions governing the taking up of the regulated professions within the framework of this Directive. To carry out this task they may call upon the existing information networks and, where appropriate, the relevant professional associations or organizations. The Commission shall take the necessary initiatives to ensure the development and coordination of the communication of the necessary information. CHAPTER IX Procedure for derogating from the right to choose between adaptation period and aptitude test Article 14 1. If, pursuant to the second sentence of the second subparagraph of Article 4 (1) (b), the third subparagraph of Article 5, or the second sentence of the second subparagraph of Article 7 (a), a Member State proposes not to grant applicants the right to choose between an adaptation period and an aptitude test, it shall immediately communicate to the Commission the corresponding draft provision. It shall at the same time notify the Commission of the grounds which make the enactment of such a provision necessary. The Commission shall immediately notify the other Member States of any draft which it has received; it may also consult the coordinating group referred to in Article 13 (2) on the draft. 2. Without prejudice to the possibility for the Commission and the other Member States to make comments on the draft, the Member State may adopt the provision only if the Commission has not taken a decision to the contrary within three months. 3. At the request of a Member State or the Commission, Member States shall communicate to them, without delay, the definitive text of any provision arising from the application of this Article. CHAPTER X Procedure for amending Annexes C and D Article 15 1. The lists of education and training courses set out in Annexes C and D may be amended on the basis of a reasoned request from any Member State concerned to the Commission. All appropriate information and in particular the text of the relevant provisions of national law shall accompany the request. The Member State making the request shall also inform the other Member States. 2. The Commission shall examine the education and training course in question and those required in the other Member States. It shall verify in particular whether the qualification resulting from the course in question confers on the holder: - a level of professional education or training of a comparably high level to that of the post-secondary course referred to in point (i) of the second indent of the first subparagraph of Article 1 (a), - a similar level of responsibility and activity. 3. The Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission. 4. The representative of the Commission 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. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 5. The Commission shall adopt measures which shall apply immediately. However, if these measures are not in accordance with the opinion of the committee, they shall be communicated by the Commission to the Council forthwith. In that event, the Commission shall defer for a period of two months the application of the measures which it has decided. 6. The Council, acting by a qualified majority, may take a different decision within the time limit referred to in the previous paragraph. 7. The Commission shall inform the Member State concerned of the decision and shall, where appropriate, publish the amended list in the Official Journal of the European Communities. CHAPTER XI Other provisions Article 16 Following the expiry of the period provided for in Article 17, Member States shall communicate to the Commission, every two years, a report on the application of the system introduced. In addition to general remarks, this report shall contain a statistical summary of the decisions taken and a description of the main problems arising from the application of this Directive. Article 17 1. Member States shall adopt the laws, regulations and administrative provisions necessary for them to comply with this Directive before 18 June 1994. They shall forthwith inform the Commission thereof. When Member States adopt these measures, the latter shall include a reference to this Directive or be accompanied by such reference at the time 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 texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 18 Five years at the latest following the date specified in Article 17, the Commission shall report to the European Parliament, the Council and the Economic and Social Committee on the progress of the application of this Directive. After conducting all necessary consultations, the Commission shall present its conclusions as to any changes which need to be made to this Directive. At the same time the Commission shall, where appropriate, submit proposals for improving the existing rules in the interest of facilitating freedom of movement, right of establishment and freedom to provide services. Article 19 This Directive is addressed to the Member States.

31992L0055

1992

Council Directive 92/55/EEC of 22 June 1992 amending Directive 77/143/EEC on the approximation of the laws of the Member States relating to roadworthiness tests for motor vehicles and their trailers (exhaust emissions) Having regard to the Treaty establishing the European Economic Community, and in particular Article 75 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 Directive 77/143/EEC (4) provides that all categories of vehicles listed in Annex I thereto must be subject to regular roadworthiness testing; Whereas that Directive provides for the adoption of separate directives to test the standards which the items listed in Annex II of that Directive must satisfy and for the establishment of technical committee to advise the Commission before it adopts measures to adjust roadworthiness tests to technical progress; Whereas this Directive is intended to maintain emissions at a low level throughout the useful life of a vehicle by means of regular exhaust emission tests and to ensure that vehicles which are major polluters are withdrawn from service until they are brought to a proper state of maintenance; Whereas most Member States have adopted procedures for testing heavy commerical vehicles with regard to the opacity of their exhaust fumes; Whereas several Member States have national rules for testing the gaseous emissions from lighter vehicles, particularly passenger cars; Whereas assessment of the type-approval procedures for testing gaseous emissions and fumes emitted by all types of vehicles shows that applying those procedures in the roadworthiness test presents some difficulty; Whereas testing during the life cycle of a vehicle should be relatively simple, quick and inexpensive; Whereas bad tuning and inadequate maintenance are detrimental not only to the engine but also to the environment since they cause increased pollution and fuel consumption; Whereas it is important that environment-friendly transport be developed; Whereas in the case of compression ignition (diesel engines) measurement of the opacity of the exhaust fumes is considered to be an adequate indicator of the condition of the vehicle's state of maintenance, with regard to emission; Whereas for positive ignition petrol engines measurement of carbon monoxide emissions from the exhaust pipe when the engine is idling is considered to be an adequate indicator of the vehicle's state of maintenance, with regard to emission; Whereas the failure rate in exhaust emission tests for vehicles which have not been regularly maintained may well be high; Whereas in the case of petrol-engined vehicles for which the type-approval standards specify that they should be equipped with advanced emission control systems such as three-way catalytic converters which are lambda-probe controlled, the regular emission test standards will be more stringent than for conventional vehicles; Whereas this Directive will be adapted from time to time to take account of developments in vehicle construction which facilitate in-service testing and in test methods which reflect more closely the actual conditions in which a vehicle is used. Article 1 Annex II to Directive 77/143/EEC is hereby amended as follows: 1. the two columns in section 8.2 (exhaust emissions) shall be replaced by the text set out in the Annex to this Directive; 2. after section 8.2, the following headings shall be inserted above the 2 columns: VEHICLES IN CATEGORIES 1, 2, 3 and 4 VEHICLES IN CATEGORIES 5 and 6 Article 2 1. Member States shall adopt and publish the laws, regulations and administrative measures necessary to comply with this Directive within one year from the date of its adoption. They shall forthwith inform the Commission thereof. 2. They shall implement these provisions at the latest by: - 1 January 1994 for the vehicles referred to in section 8.2.1 (a) of Annex II, - 1 January 1996 for the vehicles referred to in section 8.2.2 of Annex II; - 1 January 1997 for the vehicles referred to in section 8.2.1 (b) of Annex II; 3. When the Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or 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. 4. Member States shall communicate to the Commission the text of the provisions of domestic law which they adopt in the field governed by this Directive. Article 3 This Directive is addressed to the Member States.

31992L0058

1992

COUNCIL DIRECTIVE 92/58/EEC of 24 June 1992 on the minimum requirements for the provision of safety and /or health signs at work (ninth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) Having regard to the Treaty establishing the European Economic Community, and in particular Article 118 a thereof, Having regard to the proposal from the Commission (1), submitted following consultation of the Advisory Committee on Safety, Hygiene and Health Protection at Work, In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Article 118 a of the Treaty provides that the Council must adopt, by means of directives, minimum requirements to encourage improvements, especially in the working environment, as regards the health and safety of workers; Whereas, under that Article, such directives must avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings; Whereas the Commission communication on its programme concerning safety, hygiene and health at work (4) provides for a revision and extension of the scope of Council Directive. 77/576/EEC of 25 July 1977 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the provision of safety signs at places at work (5); Whereas, in its Resolution of 21 December 1987 on safety, hygiene, and health at work (6), the Council took note of the Commission's intention of submitting to it within a short period of time a proposal for revising and extending the abovementioned Directive; Whereas Directive 77/576/EEC should be replaced by this Directive for the sake of consistency and clarity; Whereas this Directive is an individual Directive within the meaning of Article 16 (l)of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (7); wheres the provisions of Directive 89/391/EEC therefore apply in full to the provision of safety and health signs at work, without prejudice to more stringent and/or specific provisions contained in this Directive; Whereas existing Community rules relate mainly to safety signs and the marking of dangerous obstacles and locations, and are therefore restricted to a limited number of types of signs; Whereas the effect of this restriction is that some hazards are not appropriately marked; whereas new types of signs should therefore be introduced in order to enable employers and workers to identify and avoid risks to safety and/or health at work; Whereas safety and/or health signs must be provided where hazards cannot be adequately reduced by techniques for collective protection or by measures, methods or procedures used in the organization of work; Whereas the many differences between the safety and/or health signs currently in use in the Member States lead to uncertainty, and this may become more widespread with the free movement of workers within the internal market; Whereas the use of standardized signs at work is, in general, likely to reduce the hazards which may arise from linguistic and cultural differences between workers; Whereas this Directive constitutes a tangible step towards developing the social dimension of the internal market; Whereas, pursuant to Decision 74/325/EEC (8), as last amended by the Act of Accession of Spain and Portugal, the Advisory Committee on Safety, Hygiene and Health Protection at Work is to be consulted by the Commission on the drafting of proposals in this field, SECTION I GENERAL PROVISIONS Article 1 Object 1. This Directive, which is the ninth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC, lays down minimum requirements for the provision of safety and /or health signs at work. 2. This Directive shall not apply to signs for the placing on the market of dangerous substances and preparations, products and /or equipment, unless other Community provisions make specific reference thereto. 3. This Directive shall not apply to signs used for regulating road, rail, inland waterway, sea or air transport. 4. The provisions of Directive 89/391/EEC shall apply in full to the whole area referred to in paragraph 1, without prejudice to more stringent and /or specific provisions in this Directive. Article 2 Definitions For the purposes of this Directive: (a) safety and/or health signs means signs referring to a specific object, activity or situation and providing information or instructions about safety and/or health at work by means of a signboard, a colour, an illuminated sign or acoustic signal, a verbal communication or a hand signal, as the case may be; (b) prohibition sign means a sign prohibiting behaviour likely to incur or cause danger; (c) warning sign means a sign giving warning of a hazard or danger; (d) mandatory sign means a sign prescribing specific behaviour; (e) emergency escape or first-aid sign means a sign giving information on emergency exits or first-aid or rescue facilities; (f) information sign means a sign providing information other than that referred to in (b) to (e); (g) signboard means a sign which provides specific information by a combination of a geometric shape, colours and a symbol or pictogram and which is rendered visible by lighting of sufficient intensity; (h) supplementary signboard means a signboard used together with one of the signs described under (g), which provides supplementary information; (i) safety colour means a colour to which a specific meaning is assigned; (j) Symbol or pictogram means a figure which describes a situation or prescribes specific behaviour and which is used on a signboard or illuminated surface; (k) illuminated sign means a sign produced by a device made of transparent or translucent materials which are illuminated from the inside or the rear in such a way as to give the appearance of a luminous surface; (l) acoustic signal means a coded sound signal which is released and transmitted by a device designed for that purpose, without the use of a human or artificial voice; (m) verbal communication means a predetermined spoken message communicated by a human or artificial voice; (n) hand signal a movement and/or position of the arms and /or hands, in coded form, for guiding persons who are carrying out manoeuvres which constitute a hazard or danger for workers. SECTION II EMPLOYERS' OBLIGATIONS Article 3 General rules 1. Employers shall provide safety and/or health signs as laid down in this Directive where hazards cannot be avoided or adequately reduced by techniques for collective protection or measures, methods or procedures used in the organization of work, or ensure that such signs are in place. Employers shall take into account any risk evaluation made in accordance with Article 6 (3) (a) of Directive 89/391/EEC. 2. Without prejudice to the provisions of Annex V, the signs used for road, rail, inland waterway, sea and air transport shall be installed, wherever appropriate for such forms of transport, inside undertakings and/or firms. Article 4 Safety and/or health signs used for the first time Without prejudice to Article 6, a safety and /or health sign used at work for the first time on or after the date referred to in Article 11 (1) first subparagraph must fulfil the minimum requirements set out in Annexes I to IX. Article 5 Safety and/or health signs already in use Without prejudice to Article 6, a safety and/or health sign which was already in use at work before the date referred to in Article 11 (1) first subparagraph must fulfil the minimum requirements set out in Annexes I to IX by no later than eighteen months after that date. Article 6 Exemptions 1. Taking account of the types of activity and/or size of the undertakings concerned, Member States may specify categories of undertakings allowed to replace totally, partially or temporarily the illuminated signs, and /or acoustic signals provided for in this Directive by alternative measures which afford the same level of protection. 2. Member States may derogate, after consulting both sides of industry, from the application of Annex VIII, section 2 and/or Annex IX, section 3, whilst laying down alternative measures guaranteeing the same level of protection. 3. Member States shall consult, in accordance with national laws and/or practice, employers' and workers' organizations when implementing paragraph 1. Article 7 Information and instruction for workers 1. Without prejudice to Article 10 of Directive 89/391/EEC, workers and/or their representatives shall be informed of all the measures to be taken concerning the safety and /or health signs used at work. 2. Without prejudice to Article 12 of Directive 89/391 /EEC, workers must be given suitable instruction, in particular in the form of specific directions concerning the safety and /or health signs used at work. In particular, the instruction referred to in the first subparagraph shall cover the meaning of the signs, especially signs incorporating words, and the general and specific behaviour to be adopted. Article 8 Consultation of workers and workers' participation Consultation and participation of workers and/or their representatives shall take place in accordance with Article 11 of Directive 89/391/EEC on the matters covered by this Directive, including Annexes I to IX. SECTION III MISCELLANEOUS PROVISIONS Article 9 Adaptation of the Annexes Adaptations of a technical nature to Annexes I to IX shall be adopted, in accordance with the procedure provided for in Article 17 of Directive 89/391/EEC, in the light of: — the adoption of directives on technical harmonization and standadization concerning the design and manufacture of safety and/or health signs or devices at work, — technical progress, changes in international rules or specifications and advances in knowledge in the field of safety and/or health signs at work. Article 10 1. Directive 77/576/EEC shall be repealed on the date referred to in Article 11 (1), first subparagraph. However, in the cases referred to in Article 5, that Directive shall continue to apply for a maximum period of eighteen months following that date. 2. Any reference to the repealed Directive shall be taken to refer to the corresponding provisions of this Directive. Article 11 Final provisions 1. Member States shall bring into force the laws, regulations and administrative provisions required to comply with this Directive no later than 24 June 1994. They shall immediately inform the Commission thereof. 2. 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. 3. Member States shall communicate to the Commission the text of the provisions of domestic law which they have already adopted or adopt in the field covered by this Directive. 4. Member States shall report to the Commission every five years on the practical implementation of the provisions of this Directive, indicating the views of employers and workers. The Commission shall inform the European Parliament, the Council, the Economic and Social Committee and the Advisory Committee on Safety, Hygiene and Health at Work thereof. 5. The Commission shall forward periodically to the European Parliament, the Council and the Economic and Social Committee a report on the implementation of this Directive, taking into account paragraphs 1 to 4. Article 12 This Directive is addressed to the Member States.

31992L0057

1992

COUNCIL DIRECTIVE 92/57/EEC of 24 June 1992 on the implementation of minimum safety and health requirements at temporary or mobile constructions sites (eighth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) Having regard to the Treaty establishing the European Economic Community, and in particular Article 118a thereof, Having regard to the proposal from the Commission (1), submitted after consulting the Advisory Committee on Safety, Hygiene and Health Protection at Work, In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Article 118 a of the Treaty provides that the Council shall adopt, by means of directives, minimum requirements for encouraging improvements, especially in the working environment, to ensure a better level of protection of the safety and health of workers; Whereas, under the terms of that Article, those directives are to avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings; Whereas the communication from the Commission on its programme concerning safety, hygiene and health at work (4) provides for the adoption of a Directive designed to guarantee the safety and health of workers at temporary or mobile construction sites; Whereas, in its resolution of 21 December 1987 on safety, hygiene and health at work (5), the Council took note of the Commission's intention of submitting to the Council in the near future minimum requirements concerning temporary or mobile construction sites; Whereas temporary or mobile construction sites constitute an area of activity that exposes workers to particularly high levels of risk; Whereas unsatisfactory architectural and /or organizational options or poor planning of the works at the project preparation stage have played a role in more than half of the occupational accidents occurring on construction sites in the Community; Whereas in each Member State the authorities responsible for safety and health at work must be informed, before the beginning of the works, of the execution of works the scale of which exceeds a certain threshold; Whereas, when a project is being carried out, a large number of occupational accidents may be caused by inadequate coordination, particularly where various undertakings work simultaneously or in succession at the same temporary or mobile construction site; Whereas it is therefore necessary to improve coordination between the various parties concerned at the project preparation stage and also when the work is being carried out; Whereas compliance with the minimum requirements designed to guarantee a better standard of safety and health at temporary or mobile construction sites is essential to ensure the safety and health of workers; Whereas, moreover, self-employed persons and employers, where they are personally engaged in work activity, may, through their activities on a temporary or mobile construction site, jeopardize the safety and health of workers; Whereas it is therefore necessary to extend to self-employed persons and to employers where they are personally engaged in work activity on the site certain relevant provisions of Council Directive 89/655/EEC of 30 November 1989 concerning the minimum safety and health requirements for the use of work equipment by workers at work (second individual Directive) (6), and of Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (third individual Directive) (7); Whereas this Directive is an individual Directive within the meaning of Article 16 (1) of Council Directive 89/391 /EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (8); whereas, therefore, the provisions of the said Directive are fully applicable to temporary or mobile construction sites, without prejudice to more stringent and/or specific provisions contained in this Directive; Whereas this Directive constitutes a practical step towards the achievement of the social dimension of the internal market with special reference to the subject matter of Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products (9) and the subject matter covered by Council Directive 89/440/EEC of 18 July 1989 amending Directive 71/305/EEC concerning coordination of procedures for the award of public work contracts (10); Whereas, pursuant to Council Decision 74/325/EEC (11), the Advisory Committee on Safety, Hygiene and Health Protection at Work is consulted by the Commission with a view to drawing up proposals in this field, Article 1 Subject 1. This Directive, which is the eighth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC, lays down minimum safety and health requirements for temporary or mobile construction sites, as defined in Article 2 (a). 2. This Directive shall not apply to drilling and extraction in the extractive industries within the meaning of Article 1 (2) of Council Decision 74/326/EEC of 27 June 1974 on the extension of the responsibilities of the Mines Safety and Health Commission to all mineral-extracting industries (12). 3. The provisions of Directive 89/391/EEC are fully applicable to the whole scope referred to in paragraph 1, without prejudice to more stringent and/or specific provisions contained in this Directive. Article 2 Definitions For the purposes of this Directive: (a) ‘temporary or mobile construction sites’ (hereinafter referred to as ‘construction sites’) means any construction site at which building or civil engineering works are carried out; a non-exhaustive list of such works is given in Annex I; (b) ‘client’ means any natural or legal person for whom a project is carried out; (c) ‘project supervisor’ means any natural or legal person responsible for the design and /or execution and /or supervision of the execution of a project, acting on behalf of the client; (d) ‘self-employed person’ means any person other than those referred to in Article 3 (a) and (b) of Directive 89/391 /EEC whose professional activity contributes to the completion of a project; (e) ‘coordinator for safety and health matters at the project preparations stage’ means any natural or legal person entrusted by the client and /or project supervisor, during preparation of the project design, with performing the duties referred to in Article 5; (f) ‘coordinator for safety and health matters at the project execution stage’ means any natural or legal person entrusted by the client and /or project supervisor, during execution of the project, with performing the duties referred to in Article 6. Article 3 Appointment of coordinators — Safety and health plan — Prior notice 1. The client or the project supervisor shall appoint one or more coordinators for safety and health matters, as defined in Article 2 (e) and (f), for any construction site on which more than one contractor is present. 2. The client or the project supervisor shall ensure that prior to the setting up of a construction site a safety and health plan is drawn up in accordance with Article 5 (b). The Member States may, after consulting both management and the workforce, allow derogations from the provisions of the first paragraph, except where the work concerned involves particular risks as listed in Annex II. 3. In the case of constructions sites: — on which work is scheduled to last longer than 30 working days and on which more than 20 workers are occupied simultaneously, or — on which the volume of work is scheduled to exceed 500 person-days, the client or the project supervisor shall communicate a prior notice drawn up in accordance with Annex III to the competent authorities before work starts. — The prior notice must be clearly displayed on the construction site and, if necessary, periodically updated. Article 4 Project preparation stage: general principles The project supervisor, or where appropriate the client, shall take account of the general principles of prevention concerning safety and health referred to in Directive 89/391/EEC during the various stages of designing and preparing the project, in particular: — when architectural, technical and/or organizational aspects are being decided, in order to plan the various items or stages of work which are to take place simultaneously or in succession, — when estimating the period required for completing such work or work stages. Account shall also be taken, each time this appears necessary, of all safety and health plans and of files drawn up in accordance with Article 5 (b) or (c) or adjusted in accordance with Article 6 (c). Article 5 Project preparation stage: duties of coordinators The coordinator(s) for safety and health matters during the project preparation stage appointed in accordance with Article 3 (1) shall: (a) coordinate implementation of the provisions of Article 4; (b) draw up, or cause to be draw up, a safety and health plan setting out the rules applicable to the construction site concerned, taking into account where necessary the industrial activities taking place on the site; this plan must also include specific measures concerning work which falls within one or more of the categories of Annex II; (c) prepare a file appropriate to the characteristics of the project containing relevant safety and health information to be taken into account during any subsequent works. Article 6 Project execution stage: duties of coordinators The coordinator(s) for safety and health matters during the project execution stage appointed in accordance with Article 3 (1) shall: (a) coordinate implementation of the general principles of prevention and safety: — when technical and/or organizational aspects are being decided, in order to plan the various items or stages of work which are to take place simultaneously or in succession, — when estimating the period required for completing such work or work stages; (b) coordinate implementation of the relevant provisions in order to ensure that employers and, if necessary for the protection of workers, self-employed persons: — apply the principles referred to in Article 8 in a consistent manner, — where required, follow the safety and health plan referred to in Article 5 (b); (c) make, or cause to be made, any adjustments required to the safety and health plan referred to in Article 5 (b) and the file referred to in Article 5 (c) to take account of the progress of the work and any changes which have occurred; (d) organize cooperation between employers, including successive employers on the same site, coordination of their activities with a view to protecting workers and preventing accidents and occupational health hazards and reciprocal information as provided for in Article 6 (4) of Directive 89/391/EEC, ensuring that self-employed persons are brought into this process where necessary; (e) coordinate arrangements to check that the working procedures are being implemented correclty; (f) take the steps necessary to ensure that only authorized person are allowed onto the construction site. Article 7 Responsibilities of clients, project supervisors and employers 1. Where a client or project supervisor has appointed a coordinator or coordinators to perform the duties referred to in Articles 5 and 6, this does not relieve the client or project supervisor of his responsibilities in that respect. 2. The implementation of Articles 5 and 6, and of paragraph 1 of this Article shall not affect the principle of employers' responsibility as provided for in Directive 89/391/EEC. Article 8 Implementation of Article 6 of Directive 89/391/EEC When the work is being carried out, the principles set out in Article 6 of Directive 89/391/EEC shall be applied, in particular as regards: (a) keeping the construction site in good order and in a satisfactory state of cleanliness; (b) choosing the location of workstations bearing in mind how access to these workplaces is obtained, and determining routes or areas for the passage and movement and equiment; (c) the conditions under which various materials are handled; (d) technical maintenance, pre-commissioning checks and regular checks on installations and equipment with a view to correcting any faults which might affect the safety and health of workers; (e) the demarcation and laying-out of areas for the storage of various materials, in particular where dangerous materials or substances are concerned; (f) the conditions under which the dangerous materials used are removed; (g) the storage and disposal or removal of waste and debris; (h) the adaptation, based on progress made with the site, of the actual period to be allocated for the various types of work or work stages; (i) cooperation between employers and self-employed persons; (j) interaction with industrial activities at the place within which or in the vicinity of which the construction site is located. Article 9 Obligations of employers In order to preserve safety and health on the construction site, under the conditions set out in Article 6 and 7, employers shall: (a) in particular when implementing Article 8, take measures that are in line with the minimum requirements set out in Annex IV; (b) take into account directions from the coordinator(s) for safety and health matters. Article 10 Obligations of other groups of persons 1. In order to preserve safety and health on the construction site, self-employed persons shall: (a) comply in particular with the following, mutatis mutandis: (i) the requirements of Article 6 (4) and Article 13 of Directive 89/391/EEC and Article 8 and Annex IV of this Directive; (ii) Article 4 of Directive 89/655/EEC and the relevant provisions of the Annex thereto; (iii) Article 3, Article 4 (1) to (4) and (9) and Article 5 of Directive 89/656/EEC; (b) take into account directions from the coordinator(s) for safety and health matters. 2. In order to preserve safety and health on the site, where employers are personally engaged in work activity on the construction site, they shall: (a) comply in particular with the following, mutatis mutandis: (i) Article 13 of Directive 89/391/EEC; (ii) Article 4 of Directive 89/655/EEC and the relevant provisions of the Annex thereto; (iii) Articles 3,4(1), (2), (3), (4), (9) and 5 of Directive 89/656/EEC; (b) take account of the comments of the coordinator(s) for safety and health. Article 11 Information for workers 1. Whitout prejudice to Article 10 of Directive 89/391/EEC, workers and/or their representatives shall be informed of all the measures to be taken concerning their safety and health on the construction site. 2. The information must be comprehensible to the workers concerned. Article 12 Consultation and participation of workers Consultation and participation of workers and /or of their representatives shall take place in accordance with Article 11 of Directive 89/391/EEC on matters covered by Articles 6, 8 and 9 of this Directive, ensuring whenever necessary proper coordination between workers and/or workers' representatives in undertakings carrying out their activities at the workplace, having regard to the degree of risk and the size of the work site. Article 13 Amendment of the Annexes 1. Amendments to Annexes I, II and III shall be adopted by the Council in accordance with the procedure laid down in Article 118a of the Treaty. 2. Strictly technical adaptations of Annex IV as a result of: — the adoption of directives on technical harmonization and standardization regarding temporary or mobile construction sites, and/or — technical progress, changes in international regulations or specifications or knowledge in the field of temporary or mobile construction sites shall be adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC. Article 14 Final provisions 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1993 at the latest. They shall forthwith inform the Commission thereof. 2. When Member States adopt these measures, they shall contain a reference to this Directive or 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. 3. Member States shall communicate to the Commission the texts of the provisions of national law which they have already adopted or adopt in the field governed by this Directive. 4. Member States shall report to the Commission every four years on the practical implementation of the provisions of this Directive, indicating the points of view of employers and workers. The Commission shall inform the European Parliament, the Council, the Economic and Social Committee and the Advisory Committee on Safety, Hygiene and Health Protection at Work. 5. The Commission shall submit periodically to the European Parliament, the Council and the Economic and Social Committee a report on the implementation of this Directive, taking into account paragraphs 1, 2, 3 and 4. Article 15 This Directive is addressed to the Member States.

31992L0059

1992

Council Directive 92/59/EEC of 29 June 1992 on general product safety 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 it is important to adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market is to comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas some Member States have adopted horizontal legislation on product safety, imposing, in particular, a general obligation on economic operators to market only safe products; whereas those legislations differ in the level of protection afforded to persons; whereas such disparities and the absence of horizontal legislation in other Member States are liable to create barriers to trade and distortions of competition within the internal market; Whereas it is very difficult to adopt Community legislation for every product which exists or may be developed; whereas there is a need for a broadly-based, legislative framework of a horizontal nature to deal with those products, and also to cover lacunae in existing or forthcoming specific legislation, in particular with a view to ensuring a high level of protection of safety and health of persons, as required by Article 100 a (3) of the Treaty; Whereas it is therefore necessary to establish on a Community level a general safety requirement for any product placed on the market that is intended for consumers or likely to be used by consumers; whereas certain second-hand goods should nevertheless be excluded by their nature; Whereas production equipment, capital goods and other products used exclusively in the context of a trade or business are not covered by this Directive; Whereas, in the absence of more specific safety provisions, within the framework of Community regulations, covering the products concerned, the provisions of this Directive are to apply; Whereas when there are specific rules of Cummunity law, of the total harmonization type, and in particular rules adopted on the basis of the new approach, which lay down obligations regarding product safety, further obligations should not be imposed on economic operators as regards the placing on the market of products covered by such rules; Whereas, when the provisions of specific Community regulations cover only certain aspects of safety or categories of risks in respect of the product concerned, the obligations of economic operators in respect of such aspects are determined solely by those provisions; Whereas it is appropriate to supplement the duty to observe the general safety requirement by an obligation on economic operators to supply consumers with relevant information and adopt measures commensurate with the characteristics of the products, enabling them to be informed of the risks that these products might present; Whereas in the absence of specific regulations, criteria should be defined whereby product safety can be assessed; Whereas Member States must establish authorities responsible for monitoring product safety and with powers to take the appropriate measures; Whereas it is necessary in particular for the appropriate measures to include the power for Member States to organize, immediately and efficiently, the withdrawal of dangerous products already placed on the market; Whereas it is necessary for the preservation of the unity of the market to inform the Commission of any measure restricting the placing on the market of a product or requiring its withdrawal from the market except for those relating to an event which is local in effect and in any case limited to the territory of the Member State concerned; whereas such measures can be taken only in compliance with the provisions of the Treaty, and in particular Articles 30 to 36; Whereas this Directive applies without prejudice to the notification procedures in Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations(4) and in Commission Decision 88/383/EEC of 24 February 1988 providing for the improvement of information on safety, hygiene and health at work(5) ; Whereas effective supervision of product safety requires the setting-up at national and Community levels of a system of rapid exchange of information in emergency situations in respect of the safety of a product and whereas the procedure laid down by Council Decision 89/45/EEC of 21 December 1988 on a Community system for the rapid exchange of information on dangers arising from the use of consumer products(6) should therefore be incorporated into this Directive and the above Decision should be repealed; whereas it is also advisable for this Directive to take over the detailed procedures adopted under the above Decision and to give the Commission, assisted by a committee, power to adapt them; Whereas, moreover, equivalent notification procedures already exist for pharmaceuticals, which come under Directives 75/319/EEC(7) and 81/851/EEC(8) , concerning animal diseases referred to in Directive 82/894/EEC(9) , for products of animal origin covered by Directive 89/662/EEC(10) , and in the form of the system for the rapid exchange of information in radiological emergencies under Decision 87/600/Euratom(11) ; Whereas it is primarily for Member States, in compliance with the Treaty and in particular with Articles 30 to 36 thereof, to take appropriate measures with regard to dangerous products located within their territory; Whereas in such a situation the decision taken on a particular product could differ from one Member State to another; whereas such a difference may entail unacceptable disparities in consumer protection and constitute a barrier to intra-Community trade; Whereas it may be necessary to cope with serious product-safety problems which affect or could affect, in the immediate future, all or a large part of the Community and which, in view of the nature of the safety problem posed by the product cannot be dealt with effectively in a manner commensurate with the urgency of the problem under the procedures laid down in the specific rules of Community law applicable to the products or category of products in question; Whereas it is therefore necessary to provide for an adequate mechanism allowing, in the last resort, for the adoption of measures applicable throughout the Community, in the form of a decision addressed to the Member States, in order to cope with emergency situations as mentioned above; whereas such a decision is not of direct application to economic operators and must be incorporated into a national instrument; whereas measures adopted under such a procedure can be no more than interim measures that have to be taken by the Commission assisted by a committee of representatives of the Member States; whereas, for reasons of cooperation with the Member States, it is appropriate to provide for a regulatory committee according to procedure III (b) of Decision 87/373/EEC(12) ; Whereas this Directive does not affect victims' rights within the meaning of Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products(13) ; Whereas it is necessary that Member States provide for appropriate means of redress before the competent courts in respect of measures taken by the competent authorities which restrict the placing on the market of a product or require its withdrawal; Whereas it is appropriate to consider, in the light of experience, possible adaptation of this Directive, particularly as regards extension of its scope and provisions on emergency situations and intervention at Community level; Whereas, in addition, the adoption of measures concerning imported products with a view to preventing risks to the safety and health of persons must comply with the Community's international obligations, TITLE I Objective - Scope - Definitions Article 1 1. The purpose of the provisions of this Directive is to ensure that products placed on the market are safe. 2. The provisions of this Directive shall apply in so far as there are no specific provisions in rules of Community law governing the safety of the products concerned. In particular, where specific rules of Community law contain provisions imposing safety requirements on the products which they govern, the provisions of Articles 2 to 4 of this Directive shall not, in any event, apply to those products. Where specific rules of Community law contain provisions governing only certain aspects of product safety or categories of risks for the products concerned, those are the provisions which shall apply to the products concerned with regard to the relevant safety aspects or risks. Article 2 For the purposes of this Directive: (a) product shall mean any product intended for consumers or likely to be used by consumers, supplied whether for consideration or not in the course of a commercial activity and whether new, used or reconditioned. However, this Directive shall not apply to second-hand products supplied as antiques or as products to be repaired or reconditioned prior to being used, provided that the supplier clearly informs the person to whom he supplies the product to that effect; (b) safe product shall mean any product which, under normal or reasonably foreseeable conditions of use, including duration, does not present any risk or only the minimum risks compatible with the product's use, considered as acceptable and consistent with a high level of protection for the safety and health of persons, taking into account the following points in particular: - the characteristics of the product, including its composition, packaging, instructions for assembly and maintenance, - the effect on other products, where it is reasonably foreseeable that it will be used with other products, - the presentation of the product, the labelling, any instructions for its use and disposal and any other indication or information provided by the producer, - the categories of consumers at serious risk when using the product, in particular children. The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering a product to be 'unsafe' or 'dangerous'; (c) dangerous product shall mean any product which does not meet the defintion of 'safe product' according to point (b) hereof; (d) producer shall mean: - the manufacturer of the product, when he is established in the Community, and any other person presenting himself as the manufacturer by affixing to the product his name, trade mark or other dinstinctive mark, or the person who reconditions the product, - the manufacturer's representative, when the manufacturer is not established in the Community or, if there is no representative established in the Community, the importer of the product, - other professionals in the supply chain, insofar as their activities may affect the safety properties of a product placed on the market. (e) distributor shall mean any professional in the supply chain whose activity does not affect the safety properties of a product. TITLE II General safety requirement Article 3 1. Producers shall be obliged to place only safe products on the market. 2. Within the limits of their respective activities, producers shall: - provide consumers with the relevant information to enable them to assess the risks inherent in a product throughout the normal or reasonably foreseeable period of its use, where such risks are not immediately obvious without adequate warnings, and to take precautions against those risks. Provision of such warnings does not, however, exempt any person from compliance with the other requirements laid down in this Directive, - adopt measures commensurate with the characteristics of the products which they supply, to enable them to be informed of risks which these products might present and to take appropriate action including, if necessary, withdrawing the product in question from the market to avoid these risks. The above measures shall for example include, whenever appropriate, marking of the products or product batches in such a way that they can be identified, sample testing of marketed products, investigating complaints made and keeping distributors informed of such monitoring. 3. Distributors shall be required to act with due care in order to help to ensure compliance with the general safety requirement, in particular by not supplying products which they know or should have presumed, on the basis of the information in their possession and as professionals, do not comply with this requirement. In particular, within the limits of their respective activities, they shall participate in monitoring the safety of products placed on the market, especially by passing on information on product risks and cooperating in the action taken to avoid these risks. Article 4 1. Where there are no specific Community provisions governing the safety of the products in question, a product shall be deemed safe when it conforms to the specific rules of national law of the Member State in whose territory the product is in circulation, such rules being drawn up in conformity with the Treaty, and in particular Articles 30 and 36 thereof, and laying down the health and safety requirements which the product must satisfy in order to be marketed. 2. In the absence of specific rules as referred to in paragraph 1, the conformity of a product to the general safety requirement shall be assessed having regard to voluntary national standards giving effect to a European standard or, where they exist, to Community technical specifications or, failing these, to standards drawn up in the Member State in which the product is in circulation, or to the codes of good practice in respect of health and safety in the sector concerned or to the state of the art and technology and to the safety which consumers may reasonably expect. 3. Conformity of a product with the provisions mentioned in paragraphs 1 or 2 shall not bar the competent authorities of the Member States from taking appropriate measures to impose restrictions on its being placed on the market or to require its withdrawal from the market where there is evidence that, despite such conformity, it is dangerous to the health and safety of consumers. TITLE III Obligations and powers of the Member States Article 5 Member States shall adopt the necessary laws, regulations and administrative provisions to make producers and distributors comply with their obligations under this Directive in such a way that products placed on the market are safe. In particular, Member States shall establish or nominate authorities to monitor the compliance of products with the obligation to place only safe products on the market and arrange for such authorities to have the necessary powers to take the appropriate measures incumbent upon them under this Directive, including the possibility of imposing suitable penalties in the event of failure to comply with the obligations deriving from this Directive. They shall notify the Commission of the said authorities; the Commission shall pass on the information to the other Member States. Article 6 1. For the purposes of Article 5, Member States shall have the necessary powers, acting in accordance with the degree or risk and in conformity with the Treaty, and in particular Articles 30 and 36 thereof, to adopt appropriate measures with a view, inter alia, to: (a) organizing appropriate checks on the safety properties of products, even after their being placed on the market as being safe, on an adequate scale, up to the final stage of use or consumption; (b) requiring all necessary information from the parties concerned; (c) taking samples of a product or a product line and subjecting them to safety checks; (d) subjecting product marketing to prior conditions designed to ensure product safety and requiring that suitable warnings be affixed regarding the risks which the product may present; (e) making arrangements to ensure that persons who might be exposed to a risk from a product are informed in good time and in a suitable manner of the said risk by, inter alia, the publication of special warnings; (f) temporarily prohibiting, for the period required to carry out the various checks, anyone from supplying, offering to supply or exhibiting a product or product batch, whenever there are precise and consistent indications that they are dangerous; (g) prohibiting the placing on the market of a product or product batch which has proved dangerous and establishing the accompanying measures needed to ensure that the ban is complied with; (h) organizing the effective and immediate withdrawal of a dangerous product or product batch already on the market and, if necessary, its destruction under appropriate conditions. 2. The measures to be taken by the competent authorities of the Member States under this Article shall be addressed, as appropriate, to: (a) the producer; (b) within the limits of their respective activities, distributors and in particular the party responsible for the first stage of distribution on the national market; (c) any other person, where necessary, with regard to cooperation in action taken to avoid risks arising from a product. TITLE IV Notification and Exchanges of Information Article 7 1. Where a Member State takes measures which restrict the placing of a product or a product batch on the market or require its withdrawal from the market, such as provided for in Article 6 (1) (d) to (h), the Member State shall, to the extent that such notification is not required under any specific Community legislation, inform the Commission of the said measures, specifying its reasons for adopting them. This obligation shall not apply where the measures relate to an event which is local in effect and in any case limited to the territory of the Member State concerned. 2. The Commission shall enter into consultations with the parties concerned as quickly as possible. Where the Commission concludes, after such consultations, that the measure is justified, it shall immediately inform the Member State which initiated the action and the other Member States. Where the Commission concludes, after such consultations, that the measures is not justified, it shall immediately inform the Member State which initiated the action. TITLE V Emergency situations and action at Community level Article 8 1. Where a Member State adopts or decides to adopt emergency measures to prevent, restrict or impose specific conditions on the possible marketing or use, within its own territory, of a product or product batch by reason of a serious and immediate risk presented by the said product or product batch to the health and safety of consumers, it shall forthwith inform the Commission thereof, unless provision is made for this obligation in procedures of a similar nature in the context of other Community instruments. This obligation shall not apply if the effects of the risk do not, or cannot, go beyond the territory of the Member State concerned. Without prejudice to the provisions of the first subparagraph, Member States may pass on to the Commission any information in their possession regarding the existence of a serious and immediate risk before deciding to adopt the measures in question. 2. On receiving this information, the Commission shall check to see whether it complies with the provisions of this Directive and shall forward it to the other Member States, which, in turn, shall immediately inform the Commission of any measures adopted. 3. Detailed procedures for the Community information system described in this Article are set out in the Annex. They shall be adapted by the Commission in accordance with the procedure laid down in Article 11. Article 9 If the Commission becomes aware, through notification given by the Member States or through information provided by them, in particular under Article 7 or Article 8, of the existence of a serious and immediate risk from a product to the health and safety of consumers in various Member States and if: (a) one or more Member States have adopted measures entailing restrictions on the marketing of the product or requiring its withdrawal from the market, such as those provided for in Article 6 (1) (d) to (h); (b) Member States differ on the adoption of measures to deal with the risk in question; (c) the risk cannot be dealt with, in view of the nature of the safety issue posed by the product and in a manner compatible with the urgency of the case, under the other procedures laid down by the specific Community legislation applicable to the product or category of products concerned; and (d) the risk can be eliminated effectively only by adopting appropriate measures applicable at Community level, in order to ensure the protection of the health and safety of consumers and the proper functioning of the common market, the Commission, after consulting the Member States and at the request of at least one of them, may adopt a decision, in accordance with the procedure laid down in Article 11, requiring Member States to take temporary measures from among those listed in Article 6 (1) (d) to (h). Article 10 1. The Commission shall be assisted by a Committee on Product Safety Emergencies, hereinafter referred to as 'the Committee', composed of the representatives of the Member States and chaired by a representative of the Commission. 2. Without prejudice to Article 9 (c), there shall be close cooperation between the Committee referred to in paragraph 1 and the other Committees established by specific rules of Community law to assist the Commission as regards the health and safety aspects of the product concerned. Article 11 1. The Commission representative shall submit to the Committee a draft of the measures to be taken. The Committee, having verified that the conditions listed in Article 9 are fulfilled, shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter but which may not exceed one month. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty for adoption of decisions by the Council on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote. The Commission shall adopt the measures in question, if they are in accordance with the opinion of the Committee. If the measures proposed are not in accordance with the Committee's opinion, or in the absence of an opinion, the Commission shall forthwith submit to the Council a proposal regarding the measures to be taken. The Council shall act by a qualified majority. If the Council has not acted whtih 15 days of the date on which the proposal was submitted to it, the measures proposed shall be adopted by the Commission unless the Council has decided against them by a simple majority. 2. Any measure adopted under this procedure shall be valid for no longer than tree months. That period may be prolonged under the dame procedure. 3. Member States shall take all necessary measures to implement the decisions adopted under this procedures within less than 10 days. 4. The competent authorities of the Member States responsible for carrying out measures adopted under this procedures shall, within one month, give the parties concerned an opportunity to submit their views and shall inform the Commission accordingly. Article 12 The Member States and the Commission shall take the steps necessary to ensure that their officials and agents are required not to disclose information obtained for the purposes of this Directive which, by its nature, is covered by professional secrecy, except for information relating to the safety propertiies of a given product which must be made public if circumstances so require, in order to protect the health and safety of persons. TITLE VI Miscellaneous and final provisions Article 13 This Directive shall be without prejudice to Directive 85/374/EEC. Article 14 1. Any decision adopted under this Directive and involving restrictions on the placing of a product on the market, or requiring its withdrawal from the market, must state the appropriate reasons on which it is based. It shall be notified as soon as possible to the party concerned and shall indicate the remedies available under the provisions in force in the Member State in question and the time limits applying to such remedies. The parties concerned shall, whenever feasible, be given an opportunity to submit their views before the adoption of the measure. If this has not been done in advance because of the urgency of the measures to be taken, such opportunity shall be given in due course after the measure has been implemented. Measures requiring the withdrawal of a product from the market shall take into consideration the need to encourage distributors, users and consumers to contribute to the implementation of such measures. 2. Member States shall ensure that any measure taken by the competent authorities involving restrictions on the placing of a product on the market or requiring its withdrawal from the market can be challenged before the competent courts. 3. Any decision taken by virtue of this Directive and involving restrictions on the placing of a product on the market or requiring its withdrawal from the market shall be entirely without prejudice to assessment of the liability of the party concernd, in the light of the national criminal law applying in the case in question. Article 15 Every two years following the date of adoption, the Commission shall submit a report on the implementation of this Directive to the European Parliament and the Council. Article 16 Four years from the date referred to in Article 17 (1), on the basis of a Commission report on the experience acquired, together with appropriate proposals, the Council shall decide whether to adjust this Directive, in particular with a view to extending its scope as laid down in Article 1 (1) and Article 2 (a), and whether the provisions of Title V should be amended. Article 17 1. Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive by 29 June 1994 at the latest. They shall forthwith inform the Commission thereof. The provisions adopted shall apply with effect from 29 June 1994. 2. When these measures are adopted by the Member States, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such a referenc shall be laid down by the Member States. 3. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the area covered by this Directive. Article 18 Decision 89/45/EEC is hereby repealed on the date referred to in Article 17 (1). Article 19 This Directive is addressed to the Member States.

31992L0060

1992

Council Directive 92/60/EEC of 30 June 1992 amending Directive 90/425/EEC concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Whereas the Community is to adopt measures designed to establish the internal market progressively over a period expiring on 31 December 1992; Whereas Directive 90/425/EEC (3) provides that veterinary checks on certain live animals and animal products are no longer to be carried out at the Community's internal borders; Whereas, since adopting Directive 90/425/EEC, the Council has fixed the principles governing the organization of veterinary checks on live animals and animal products entering the Community from third countries; whereas, in this respect, account should be taken of Council Directive 70/675/EEC of 10 December 1990, laying down the principles govering the organization of veterinary checks on products entering the Community from third countries (4) and Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC (5); Whereas the fourth paragraph of Article 21 of Directive 90/452/EEC provides for the inclusion in the scope of the said Directive, and of Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (6) of live animals and products of animal origin not covered by the said Directives; Whereas Article 25 of Directive 90/425/EEC stipulates that the arrangements which are to apply when the transitional provisions provided for in Article 24 expire must be determined; whereas, in this regard, account should be taken of the progress made in the Community as regards both the adoption of rules concerning live animals and animal products from third countries and the harmonization of measures to control foot-and-mouth disease and swine fever, specifically Council Directive 90/423/EEC of 26 June 1990 amending Directive 85/511/EEC introducing Community measures for the control of foot-and-mouth disease, Directive 64/432/EEC on animal health problems affecting intra-Community trade in bovine animals and swine and Directive 72/462/EEC on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat or meat products from third countries (7) and Council Directive 91/685/EEC of 11 December 1991 amending Directive 80/217/EEC introducing Community measures for the control of classical swine fever (8); Whereas, particularly in the light of the progress made in harmonizing veterinary rules, provision should be made for the abolition, from 1 July 1992, of veterinary checks carried out at internal borders on all live animals and animal products; Whereas, however, provision must be made for specific rules concerning the veterinary checks applicable to movements of pets accompanied by and under the responsibility of a natural person, where such movements are not the subject of a commercial transaction, Article 1 Directive 90/425/EEC is herby amended as follows: 1. the following paragraph shall be added to Article 1: 'This Directive shall not apply to veterinary checks on movements between Member States of pets accompanied by and under the responsibility of a natural person, where such movements are not the subject of a commercial transaction.'; 2. in Article 7 (2), '1 January 1993' shall be replaced by '1 July 1992'; 3. in the first paragraph of Article 21, the words 'until 31 December 1992' shall be deleted; 4. the second paragraph of Article 21 is replaced by the following: 'Member States shall communicate to the Commission and the other Member States the conditions and procedures applicable to trade in the animals and products referred to in the first paragraph.'; 5. the last sentence of the fourth paragraph of Article 21 shall be deleted; 6. Article 22 shall be replaced by the following: 'Article 22 1. Member States shall submit to the Commission, using a harmonized model, the relevant information concerning the checks carried out pursuant to this Directive. 2. The Commission shall examine the information referred to in paragraph 1 within the Standing Veterinary Committee. It may adopt appropriate measures in accordance with the procedure laid down in Article 18. 3. Detailed rules for the application of this Article, in particular the frequency of communication of information, the model to be used and the type of information required, shall be laid down in accordance with the procedure laid down in Article 18.'; 7. Article 24 shall be replaced by the following: 'Article 24 Until 31 December 1992 in order to permit the gradual implementation of the checking arrangements laid down by this Directive, Member States may operate: - documentary checks during transport of animals and products covered by Annexes A and B or imported from third countries, - spot veterinary checks of a non-discriminatory nature during transport of animals and products covered by Annex B;'; 8. Article 25 shall be deleted; 9. Part A of Annex B shall be replaced by the following: 'A. Veterinary legislation - Other live animals not covered by Annex A.I.'; 10. Part B of Annex B shall be replaced by the following: 'B. Veterinary legislation - Semen, ova and embryos not covered by Annex A.I.' Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 1 July 1992. They shall forthwith inform the Commission thereof. When these measures are adopted by the Member States, 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 texts of the main provisions of domestic law which they adopt in the field governed by this Directive. Article 3 This Directive is addressed to the Member States.

31992L0062

1992

Commission Directive 92/62/EEC of 2 July 1992 adapting to technical progress Council Directive 70/311/EEC relating to steering equipment for motor vehicles and their trailers Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 70/311/EEC of 8 June 1970, on the approximation of the laws of the Member States relating to steering equipment of motor vehicles and their trailers (1) and in particular Article 3 thereof, Whereas a comprehensive evaluation of Directive 70/311/EEC has shown that it is possible to improve road safety further by applying practical experience and technological development and taking into account the progress made in the Economic Commission for Europe of the United Nations, notably in Regulation No 79 and supplements 1 and 2 thereto. These improvements may be obtained by reducing steering control effort, inserting requirements for power-assisted steering equipment using the same energy source as the braking device, introducing a steering test at higher speed for motor vehicles, introducing requirements for auxiliary steering equipment, and introducing a uniform presentation for the information document and the EEC type-approval certificate in order to facilitate computerization of storage and transmission of data by applicants and approval authorities; Whereas it is also necessary to adapt to technical progress definitions and existing requirements; Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the directives on the removal of technical barriers to trade in motor vehicles, set up under Article 12 (1) of Directive 70/156 (2), Article 1 1. Directive 70/311/EEC is modified as follows: in Article 2 the word 'Annex' is replaced by the word 'Annexes'. 2. The Annex is replaced by the Annexes to this Directive. Article 2 1. With effect from 1 January 1993 no Member State may on grounds relating to steering equipment: - refuse, in respect of a type of vehicle, to grant EEC type-approval, or to issue the copy of the certificate provided for in the last indent of Article 10 (1) of Council Directive 70/156/EEC, or to grant national type-approval, or - prohibit the entry into service of vehicles, if the steering equipment of this type of vehicle or of these vehicles comply with the provisions of Directive 70/311/EEC, as amended by this Directive. 2. With effect from 1 October 1993 Member States: - shall no longer issue the copy of the certificate provided for in the last indent of Article 10 (1) of Directive 70/156 in respect of a type of vehicle, - may refuse to grant national type-approval in respect of a type of vehicle, of which the steering equipment does not comply with the provisions of Directive 70/311/EEC, as amended by this Directive. 3. With effect from 1 October 1995 Member States may prohibit the entry into service of vehicles of which the steering equipment does not comply with the provisions of Directive 70/311/EEC, as amended by this Directive. Article 3 1. Member States shall implement the provisions necessary to comply with this Directive before 1 January 1993. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall ensure that they communicate to the Commission the wording of any essential provisions of national law that they adopt in the field covered by this Directive. Article 4 This Directive is addressed to the Member States.

31992L0063

1992

Commission Directive 92/63/EEC of 10 July 1992 amending the Annexes to Council Directive 74/63/EEC on undesirable substances and products in animal nutrition Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 74/63/EEC of 17 December 1973 on undesirable substances and products in animal nutrition (1), as last amended by Directive 87/519/EEC (2), and in particular Article 6 thereof, Whereas Directive 74/63/EEC provides for regular amendment of the content of its Annexes to take account of advances in scientific and technical knowledge; Whereas there are grounds to reduce the level of cadmium and to limit the level of arsenic in phosphates used as raw materials in compound feedingstuffs in order to improve the protection for animal and human health; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Comittee for Feedingstuffs, Article 1 Annex II to Directive 74/63/EEC is hereby amended as set out in the Annex hereto. Article 2 Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 31 March 1993. They shall immediately inform the Commission thereof. When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

31992L0064

1992

Commission Directive 92/64/EEC of 13 July 1992 amending Council Directive 70/524/EEC concerning additives in feedingstuffs Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Commission Directive 91/620/EEC (2), and in particular Article 7 thereof, Whereas Directive 70/524/EEC provides for regular amendment of the content of its Annexes to take account of advances in scientific and technical knowledge; whereas the Annexes have been codified by Commission Directive 91/248/EEC (3); Whereas the use of the antibiotic 'Avilamycin', of the coccidiostats 'Lasalocid sodium' and 'Maduramicin ammonium', as well as of the binder 'synthetic calcium aluminates' has been widely tested in certain Member States; whereas, on the basis of experience gained, it appears that these new uses can be authorized throughout the Community; Whereas the additive 'zinc oxide' can, according to its origins, contain significant quantities of lead and whereas it is appropriate to limit the content of this substance in order to prevent undesirable effects on health; Whereas new uses of the coccidiostat 'halofuginone' and of the binder 'synthetic calcium aluminates' have been successfully tested in certain Member States; whereas it is appropriate to authorize these new uses provisionally at national level, while waiting for them to be authorized at Community level; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs, Article 1 The Annexes to Directive 70/524/EEC are hereby amended as set out in the Annex hereto. Article 2 Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 31 March 1993 at the latest. They shall immediately inform the Commission thereof. When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

31992L0065

1992

Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof, Having regard to the proposals 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 live animals and products of animal origin are included in the list of products in Annex II to the Treaty; whereas the placing on the market of such animals and products constitutes a source of income for part of the farming population; Whereas in order to ensure the rational development in this sector and increase productivity, animal health rules for the animals and products should be laid down at Community level; Whereas the Community must adopt the measures intended to establish the internal market progressively over a period expiring on 31 December 1992; Whereas in view of the abovementioned objectives the Council has laid down animals health rules applicable to cattle, swine, sheep and goats, equidae, poultry and hatching eggs, fish and fish products, bivalve molluscs, semen of bulls and boars, ovine embryos, fresh meat, poultrymeat, meat products, game meat and rabbit meat; Whereas animal health rules should be adopted for the placing on the market of animals and products of animal origin which are not yet covered by the abovementioned rules; Whereas provision should be made for applying this Directive without prejudice to Council Regulation (EEC) No 3626/82 of 3 December 1982 on the implementation in the Community of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (4); Whereas, as regards certain technical aspects, reference must be made to Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (5) and Directive 85/511/EEC of 18 November 1985 introducing Community measures for the control of foot-and-mouth disease (6); Whereas, in respect of the organization of checks and the follow-up thereto, as well as the safeguard measures to be implemented, reference must be made to the general rules laid down in Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (7); Whereas, save where otherwise provided, trade in animals and products of animal origin must be liberalized, without prejudice to recourse to possible safeguard measures; Whereas, given the significant risk of the spread of diseases to which animals are exposed, for certain animals and products of animal origin particular requirements should be specified to be imposed when they are placed on the market for the purposes of trade, particularly when intended for regions with a high health status; Whereas the specific situation pertaining in the United Kingdom of Great Britain and Northern Ireland and in Ireland given the insular position of those countries, and the fact that they have been free of rabies for a considerable period of time, warrants particular provisions to ensure that the placing on the market in the United Kingdom and Ireland of dogs and cats which do not originate in those countries does not involve a risk of introducing rabies into those States, without however affecting the abolition of veterinary checks at the frontiers between Member States; Whereas a health certificate is the most appropriate means of guaranteeing and monitoring compliance with these requirements; Whereas, to maintain the health situation in the Community, when the animals and products of animal origin referred to in this Directive are placed on the market, they should be made subject to the minimum requirements laid down for trade and compliance therewith monitored in accordance with the principles and rules laid down in Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries (8); Whereas provision should be made for a procedure establishing close co-operation between the Member States and the Commission within the Standing Veterinary Committee; Whereas the deadline for transposition into national law, set at 1 January 1994 in Article 29, should not affect the abolition of veterinary checks at frontiers on 1 January 1993, CHAPTER I General provisions Article 1 This Directive lays down the animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC. This Directive shall apply without prejudice to the provisions adopted pursuant to Regulation (EEC) No 3626/82. This Directive shall not affect the national rules applicable to pet animals, although their retention may not jeopardize the abolition of veterinary checks at the frontiers between Member States. (¹) OJ No L 373, 31. 12. 1990, p. 1. Amended by Directive 91/496/EEC (OJ No L 268, 24. 9. 1991, p. 56). Article 2 1. For the purposes of this Directive: (a) 'trade' means trade as defined by Article 2 (3) of Directive 90/425/EEC; (b) 'animals' means specimens of animal species other than those referred to in Directives 64/432/EEC, 90/426/EEC (²), 90/539/EEC (³), 91/67/EEC (& {È%};), 91/68/EEC (& {È& };), 91/492/EEC (& {È(};) and 91/493/EEC (& {È)};); (c) 'approved body, institute or centre' means any permanent, geographically limited establishment, approved in accordance with Article 13, where one or more species of animal are habitually kept or bred, whether or not for commercial ends, and exclusively for one or more of the following purposes: - display of the animals and education of the public - conservation of the species; - basic or applied scientific research or breeding of animals for the purposes of such research; (d) 'notifiable diseases' means the diseases listed in Annex A. 2. In addition, the definitions, other than those of approved centres and bodies, contained in Article 2 of Directives 64/432/EEC, 91/67/EEC and 90/539/EEC shall apply mutatis mutandis. (²) Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third countries of equidae (OJ No L 224, 18. 8. 1990, p. 42). Amended by Directive 91/496/EEC (OJ No L 268, 24. 9. 1991, p. 56). (³) Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (OJ No L 303, 31. 10. 1990, p. 6). Last amended by Directive 91/496/EEC (OJ No L 268, 24. 9. 1991), p. 56). (& {È%};) Council Directive 91/67/EEC of 28 January 1991 concerning the animal health conditions governing the placing on the market of aquaculture animals and products (OJ No L 46, 19. 2. 1991, p. 1). (& {È& };) Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (OJ No L 46, 19. 2. 1991, p. 1). (& {È(};) Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve moluscs (OJ No L 268, 24. 9. 1991, p. 1). (& {È)};) Council Directive 91/493/EEC of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products (OJ No L 268, 24. 9. 1991, p. 15). CHAPTER II Provisions applicable to trade Article 3 The Member States shall ensure that the trade referred to in Article 1, first paragraph, is not prohibited or restricted for animal health reasons other than those arising from the application of this Directive or from Community legislation, and in particular any safeguard measures taken. Article 4 Member States shall take the necessary measures to ensure that, for the purposes of applying Article 4 (1) (a) of Directive 90/425/EEC, the animals referred to in Articles 5 to 10 of this Directive may without prejudice to Article 13 and to the particular provisions to be adopted in implementation of Article 24, be the subject of trade only if they satisfy the conditions laid down in Articles 5 to 10 and come from the holdings or businesses referred to in Article 12 (1) and (3) of this Directive which are registered by the competent authority and which undertake to: - have the animals held examined regularly in accordance with Article 3 (3) of Directive 90/425/EEC, - notify the competent authority, aside from the outbreak of notifiable diseases, of the outbreak of the diseases referred to in Annex B for which the Member State concerned has drawn up a control or monitoring programme, - comply with the specific national measures to control a disease which is of particular importance to a given Member State and is covered by a programme drawn up in accordance with Article 14 or a decision under Articles 15 (2), - place on the market for the purposes of trade only animals which show no signs of disease and which come from holdings or areas not subject to any ban on animal health grounds and with respect to animals not accompanied by a health certificate or a commercial document provided for in Articles 5 to 11, only animals accompanied by self-certification by the operator stating that the animals in question do not at the time of dispatch show any obvious signs of disease and that his holding is not subject to any animal-health restrictions, - comply with the requirements ensuring the welfare of the animals held. Article 5 1. Member States shall ensure that trade in apes (simiae and prosimiae) is restricted solely to animals consigned from and to a body, institute or centre approved by the competent authorities of the Member States in accordance with Article 13 and that such animals are accompanied by a veterinary certificate corresponding to the specimen in Annex E, the declaration in which must be completed by the official veterinarian of the body, institute or centre of origin to guarantee the animals' health. 2. The competent authority of a Member State may, by way of derogation from paragraph 1, authorize the acquisition by an approved body, institute or centre of apes belonging to an individual. Article 6 A. Without prejudice to Article 14 and 15, Member States shall ensure that ungulates of species other than those referred to in Directives 64/432/EEC, 90/426/EEC and 91/68/EEC may be the subject of trade only if they meet the following requirements: 1. in general they: (a) must be identified in accordance with Article 3 (1) (c) of Directive 90/425/EEC; (b) must not be intended for slaughter under a programme for the eradication of an infectious disease; (c) must not have been vaccinated against foot-and-mouth disease and must satisfy the relevant requirements of Directive 85/511/EEC and Article 4a of Directive 64/432/EEC; (d) must come from a holding referred to in Article 3 (2) (b) and (c) of Directive 64/432/ EEC which is not the subject of animal health measures, particularly those taken under Directives 85/511/EEC, 80/217/EEC (¹) and 91/68/EEC and have been kept therein permanently since birth or for the last thirty days before dispatch; (e) if imported: - must come from a third country included in a column entitled 'other ungulates' to be inserted in the list drawn up in accordance with Article 3 of Directive 72/462/ EEC (²), (¹) Council Directive 80/217/EEC of 22 January 1980 introducing Community measures for the control of classical swine fever (OJ No L 47, 21. 2. 1980, p. 11). Last amended by Directive 87/486/EEC (OJ No L 280, 3. 10. 1987, p. 21). (²) Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat from third countries (OJ No L 302, 31. 12. 1972, p. 28). Last amended by Directive 91/497/EEC (OJ No L 268, 24. 9. 1991, p. 69). - must meet specific animal health conditions, to be laid down under the procedure provided for in Article 26, which are at least equivalent to the requirements of this Article; (f) must be accompanied by a certificate corresponding to the specimen given in Annex E bearing the following declaration: 'Declaration I, the undersigned (official veterinarian) certify that the ruminant/suida (a) other than that covered by Directive 64/432/EEC: (a) belongs to the . . . . . . species; (b) at the time of examination, does not show any clinical sign of any disease to which it is susceptible; (c) comes from an officially tuberculosis-free/officially brucellosis-free or brucellosis-free herd/a holding not subject to swine-fever restrictions (a) or from a holding where it was subjected with negative results to the tests laid down in Article 6 (2) (a) (ii) of Directive 92/65/EEC. (a) Delete as appropriate'; 2. in the case of ruminants: (a) they must come from an officially tuberculosis-free and officially brucellosis-free herd in accordance with Directive 64/432/EEC or Directive 91/68/EEC and satisfy, as regards animal health rules, the relevant requirements laid down for the bovine species in Article 3 (2) (c), (d), (f), (g) and (h) of Directive 64/432/EEC or Article 3 of Directive 91/68/EEC; (b) where they do not come from a herd meeting the conditions laid down in (a), they must come from a holding in which no case of brucellosis or tubercolosis has been recorded in the 42 days preceding loading of the animals and in which the ruminants have, in the 30 days prior to their dispatch, undergone with negative results: - a tuberculosis reaction test, and - a test designed to show the absence of antibodies to brucellosis. The requirements as regards these tests and the definition of the tuberculosis and brucellosis status of these holdings shall be established in accordance with the procedure laid down in Article 26 of this Directive. Pending the decisions provided for in the preceding subparagraph, national rules shall continue to apply, particularly as regards tuberculosis; 3. in the case of suidae: (a) they must not have come from an area which is the subject of prohibition measures associated with the presence of African swine fever in accordance with Article 9a of Directive 64/432/EEC; (b) they must come from a holding which is not subject to any of the restrictions laid down in Directive 80/217/EEC as a result of classical swine fever; (c) they must come from a brucellosis-free holding in accordance with Directive 64/432/EEC and satisfy the relevant animal health requirements laid down for swine in Directive 64/432/EEC; (d) where they do not come from a herd meeting the conditions set out in (c), they must, in the 30 days prior to their dispatch, have undergone with negative results a test designed to show the absence of antibodies to brucellosis. B. Directive 64/432/EEC is amended as follows: 1. in Article 2 (b) and (c), for 'bovine animal(s)' read 'animal(s) of the bovine species (including Bubalus bubalus)'; 2. the following Article is inserted: 'Article 10a Under the procedure laid down in Article 12, the health certificates, a specimen of which is reproduced in Annex F, may be amended or supplemented, in particular in order to take account of the requirements of Article 6 of Directive 92/65/EEC.' Article 7 A. Member States shall ensure that birds other than those referred to in Directive 90/539/EEC may be the subject of trade only if they meet the following requirements: 1. in general they must: (a) come from a holding in which avian influenza has not been diagnosed in the 30 days preceeding the dispatch; (b) come from a holding or an area not subject to restrictions under measures to be applied to combat Newcastle disease. Pending the implementation of the Community measures referred to in Article 19 of Directive 90/539/EEC, national requirements for combating Newcastle disease shall continue to apply, in compliance with the general provisions of the Treaty; (c) have, in accordance with the third indent of Article 10 (1) of Directive 91/496/EEC, been quarantined, if they have been imported from a third country, in the holding to which they were taken after they entered the territory of the Community; 2. in addition, psittacidae must: (a) not come from a holding nor have been in contact with animals from a holding on which psittacosis (Chlamydia psittaci) has been diagnosed. The period of prohibition since the last recorded case and the period of treatment under veterinary supervision recognized under the procedure provided for in Article 26 must be at least two months; (b) be identified in accordance with Article 3 (1) (c) of Directive 90/425/EEC. The methods for identifying psittacidae, and in particular sick psittacidae, shall be established under the procedure provided for in Article 26; (c) be accompanied by a commercial document signed by the official veterinarian or by the veterinarian responsible for the holding or business of origin and empowered for this purpose by the competent authority. B. In the second subparagraph of Article 2 (2) of Council Directive 91/495/EEC of 27 November 1990 concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat (¹), the words 'and ratites (Ratitae)' shall be inserted in the third line after the words 'Directive 90/539/EEC'. In point 1 of Article 2 (2) of Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from, third countries of poultry and hatching eggs (²), the words 'and ratites (Ratitae)' shall be inserted after the words 'and partridges.' (¹) OJ No L 268, 24. 9. 1991, p. 41. (²) OJ No L 303, 31. 10. 1990, p. 6. Article 8 Member States shall ensure that bees (Apis melifera) may be the subject of trade only if they meet the following requirements: (a) come from an area which is not the subject of a prohibition order associated with an occurrence of American foulbrood. The period of prohibition must continue for at least 30 days following the last recorded case and the date on which all hives within a radius of three kilometres have been checked by the competent authority and all infected hives burned or treated and inspected to the satisfaction of the said competent authority. In accordance with the procedure laid down in Article 26, and after consulting the Scientific Veterinary Committee, the requirements applied to bees (Apis melifera) or equivalent requirements may be applied to bumble bees; (b) are accompanied by a health certificate corresponding to the specimen in Annex E the declaration in which is completed by the competent authority to certify that the requirements laid down in (a) are met. Article 9 1. Member States shall ensure that lagomorphs may be the subject of trade only if they meet the following requirements: (a) they must not come from or have been in contact with animals from a holding on which rabies is present or is suspected of having been present within the last month; (b) they must come from a holding in which no animal shows clinical signs of myxomatosis. 2. Member States which require a health certificate for movements of lagomorphs in their territory may require animals being sent to them to be accompanied by a health certificate corresponding to the specimen in Annex E, supplemented by the following declaration: 'I, the undersigned, . . ., certify that the above consignment satisfies the requirements of Article 9 of Directive 92/65/EEC and that the animals showed no clinical sign of disease on examination.' This certificate must be issued by the official veterinarian or by the veterinarian responsible for the holding of origin and empowered for this purpose by the competent authority and for industrial breeding, by the official veterinarian. Member States wishing to use this option shall inform the Commission which must ensure that the requirement laid down in the first paragraph has been satisfied. 3. Ireland and the United Kingdom may require the submission of a health certificate guaranteeing that the requirement laid down in paragraph 1 (a) has been satisfied. Article 10 1. Member States shall ensure that there is a prohibition on trade in ferrets, mink and foxes which come from or have been in contact with animals from a holding on which rabies is present or is suspected of having been present within the previous six months, inasmuch as no systematic vaccination programme is applied. 2. To be the subject of trade, with the exception of trade between the Member States referred to in paragraph 3, dogs and cats must satisfy the following requirements: (a) animals more than three months old must: - show no sign of disease, and particularly of contagious diseases of the species, on the day they are dispatched from the holding, - be tattooed or have a micro-chip identification system implanted in accordance with detailed rules to be laid down under the procedure provided for in Article 26, - have after the age of three months, been vaccinated against rabies with an annual booster injection or, at intervals authorized by the Member States of dispatch for that vaccine, by injection of an inactivated vaccine of at least one international antigenic unit (WHO standard) measured in accordance with the activity test by the method described by the European Pharmacopoeia and recognized under the procedure laid down in Article 26. The vaccination must be certified by an official veterinarian or by the veterinarian responsible for the holding of origin and empowered for this purpose by the competent authority. The vaccination certificate must bear the name of the vaccine and its batch number (self-adhesive label if possible): - dogs must have been vaccinated against canine distemper, - be accompanied by an individual passport allowing the animal to be clearly identified and showing the dates of vaccination and/or a certificate corresponding to the specimen shown in Annex E supplemented by the following declaration completed by an official veterinarian or by the veterinarian responsible for the holding of origin and empowered for this purpose by the competent authority: 'I, the undersigned . . . . . . . . . . certify that the cats/dogs covered by this certificate satisfy the requirements of Article 10 (2) (a) and (b) and (3) (b) of Directive 92/65/EEC (a) and come from a holding in which no case of rabies has been recorded in the last six months. (a) Delete as applicable'; (b) animals less than three months old must: - satisfy the requirements of the first and fifth indents of (a), - not come from a holding which is the subject of restrictions on the movement of animals on animal health grounds, - have been born on the holding of origin and have been maintained in captivity since birth. 3. As from 1 July 1994, by way of derogation from paragraph 2, the placing on the market in the United Kingdom and Ireland of cats and dogs not originating in those countries shall be subject to the following conditions: (a) in general, cats and dogs must (i) come from a registered holding, registration of which must be suspended by the competent authority where the conditions provided for in Article 4 are no longer met; (ii) on the day they are dipatched from the holding in question, show no sign of contagious disease; (iii) have been provided with a system of identification in accordance with detailed rules to be established under the procedure laid down in Article 26; (iv) have been born on the holding and have been maintained in captivity there since birth with no contact with wild animals susceptible to rabies; (v) in the case of dogs, have been vaccinated against canine distemper; (vi) be transported in a means of transport recognized for these purposes by the competent authority of the Member States of dispatch; (vii) be accompanied by an individual vaccination record allowing the animal and its origin to be clearly identified and showing the dates of vaccination, and by a certificate corresponding to a specimen to be drawn up under the procedure laid down in Article 26 and completed by an official veterinarian or by the veterinarian responsible for the holding of origin and empowered for this purpose by the competent authority; (b) in addition, they must: (i) either have been vaccinated against rabies after the age of three months and at least six months before dispatch by injection of an inactivated vaccine of at least 1 international antigenic unit (WHO standard) measured in accordance with the activity test by the method described by the European pharmacopoeia and recognized under the procedure laid down in Article 26, with annual booster injection, or at intervals authorized by the Member State of dispatch for that vaccine. The vaccination must be certified by an official veterinarian or by the veterinarian responsible for the holding of origin and empowered for this purpose by the competent authority. The vaccination certificate must bear the name of the vaccine and its batch number (self-adhesive label if possible). Moreover, have undergone, following a vaccination, a serological test showing a protective antibody titre of at least 0,5 international units, which serological test should be carried out in accordance with WHO specifications. If the test is carried out after the first vaccination it must be carried out between the first and third month after the vaccination. (ii) or, where the conditions provided for in (i) are not met, be sent under supervision to a quarantine station approved by the Member State of destination to undergo a six-month period of quarantine. Until 1 July 1994, national regulations applicable with respect to rabies shall remain in force, although such retention may not affect the abolition of veterinary checks at the frontiers between Member States. 4. Ireland and the United Kingdom may without prejudice to paragraphs 2 and 3, retain their national regulations on quarantine for all carnivores, primates, bats and other animals susceptible to rabies covered by this Directive which cannot be shown to have been born on the holding of origin and kept in captivity since birth, although the retention of those regulations may not jeopardize the abolition of veterinary checks at the frontiers between Member States. 5. Decision 90/638/EEC is amended as follows: 1. the following indent is added to Article 1: '- for programmes to control rabies: the criteria set out in Annex III.'; 2. the following Annex is added: 'ANNEX III Criteria for programmes to control rabies Programmes to control rabies shall contain at least: (a) the criteria referred to in points 1 to 7 of Annex 1; (b) detailed information regarding the region or regions in which the oral immunization of foxes is to take place and its natural limits. This region or these regions must cover at least 6 000 km² or the total national area of a Member State and may include adjacent areas of a third country; (c) detailed information regarding the vaccines to be used, the distribution system, the density and frequency of bait-laying; (d) where appropriate, all details and the cost and purpose of schemes to conserve or preserve flora and fauna undertaken by voluntary organizations on the territory covered by these projects.' 6. The Council, acting by a qualified majority on a proposal from the Commission, shall designate a specific institute to establish the criteria necessary for the standardization of the serological tests and shall decide on its responsibilities. 7. Member States shall ensure that the costs of applying the serological test are borne by the importers. 8. This Article, and in particular the application of the serological test provided for in paragraph 3 (b), will be reviewed before 1 January 1997 in the light of developments in the rabies situation in the Member States. Article 11 1. The Member States shall ensure that, without prejudice to the decisions to be taken in implementation of Articles 21 and 23, only semen, ova and embryos meeting the conditions laid down in paragraphs 2, 3 and 4 are the subject of trade. 2. Semen of the ovine, caprine and equine species must, without prejudice to any criteria to be complied with for the entry of equids in stud books for certain specific breeds: - have been collected and processed with a view to artificial insemination in a centre approved from the health point of view in accordance with Annex D (I), or, in the case of ovine and caprine animals by way of derogation from the above, in a holding satisfying the requirements of Directive 91/68/EEC, - have been collected from animals meeting the conditions laid down in Annex D (II) (admission and routine checks on animals), - have been collected, processed and preserved in accordance with Annex D (III), - have been accompanied during transport to another Member State by a health certificate corresponding to a specimen to be determined under the procedure provided for in Article 26. 3. Ova and embryos of the ovine/caprine and equine species and of swine must: - have been removed by a collection team approved by the competent authority of the Member State and processed in an appropriate laboratory from donor females meeting the conditions laid down in Annex D (IV), - have been treated and stored in accordance with Annex D (III), - be accompanied during transport to another Member State by a health certificate corresponding to a specimen to be defined under the procedure laid down in Article 26. Semen used for the insemination of donor females must comply with the provisions of paragraph 2 in the case of sheep, goats and equids and with the provisions of Directive 90/429/EEC for swine. Any additional guarantees may be determined under the procedure laid down in Article 26. 4. Before 31 December 1997 the Commission shall submit a report together with any appropriate proposals on the implementation of this Article in the light in particular of scientific and technological developments. Article 12 1. The rules on checks established by Directive 90/425/EEC shall apply, in particular as regards the organization of and follow-up to the checks to be carried out, to the animals, semen, ova and embryos covered by this Directive which are accompanied by a health certificate. Other animals must come form holdings subject to the principles of that Directive as regards checks on origin and destination. 2. Article 10 of Directive 90/425/EEC shall apply to animals, semen, ova and embryos covered by this Directive. 3. For the purpose of trade, Article 12 of Directive 90/425/EEC shall extend to dealers who keep, on a permanent or occasional basis, animals referred to in Articles 7, 9 and 10. 4. The communication of the place of destination as provided for in Article 4 (2) of Directive 90/425/EEC shall, in respect of animals, semen, ova or embryos accompanied by a health certificate in accordance with this Directive, take place using the Animo system. 5. Without prejudice to the specific provisions of this Directive, the competent authority shall, where it is suspected that this Directive has not been complied with or there is doubt as to the health of the animals or the quality of the semen, ova and embryos referred to in Article 1, carry out any checks it deems appropriate. 6. Member States shall take the appropriate administrative or penal measures to penalize any infringement of this Directive, in particular where it is found that the certificates or documents drawn up do not correspond to the actual state of the animals referred to in Article 1, that the identification of the animals or the marking of the semen, ova and embryos in question does not comply with this Directive or that the animals or products in question have not undergone the checks provided for in this Directive. Article 13 1. Trade in animals of species susceptible to the diseases listed in Annex A or to the diseases listed in Annex B, where the Member State of destination applies the guarantee provided for in Articles 14 and 15, and trade in semen, ova or embryos of such animals consigned to and from bodies, institutes or centres approved in accordance with Annex C shall be subject to production of a transport document corresponding to the specimen in Annex E. This document, which must be completed by the veterinarian responsible for the body, institute or centre of origin, must specify that the animals, semen, ova or embryos come from a body, institute or centre approved in accordance with Annex C and must accompany them during transport. 2. (a) To be approved, bodies, institutes or centres shall, as regards notifiable diseases, submit to the competent authority of the Member State all relevant supporting documents relating to the requirements contained in Annex C. (b) After receiving the file relating to the request for approval or for renewal of approval, the competent authority shall examine it in the light of the information it contains and, where appropriate, of the results of the tests conducted on the spot. (c) The competent authority shall withdraw approval in accordance with point 3 of Annex C. (d) Each Member State shall send the Commission a list of approved bodies, institutes and centres, together with any changes to the list. The Commission shall forward this information to the other Member States. Article 14 1. Where a Member State draws up or has drawn up, either directly or through the breeders, a voluntary or compulsory control or monitoring programme for one of the diseases referred to in Annex B, it may present the programme to the Commission outlining in particular: - the distribution of the disease in its territory, - whether the disease is notifiable, - reasons for undertaking the programme, taking account of its cost-effectiveness and the significance of the disease, - the geographical area in which the programme is to be implemented, - the status categories to be applied to establishments, the requirements for each species when being introduced into a holding and the test procedures to be used, - the programme monitoring procedures, including the extent of the breeders' involvement in implementing the control or monitoring programme, - the action to be taken if, for any reason, a holding loses its status, - the measures to be taken if the results of the tests carried out under the programme are positive, - the non-discriminatory nature of trade in the territory of the Member State concerned with respect to intra-Community trade. 2. The Commission shall examine the programmes presented by the Member States. Programmes may be approved under the procedure provided for in Article 26 in compliance with the criteria laid down in paragraph 1. Under the same procedure, the additional guarantees, general or limited, which may be required in trade, shall be defined at the same time or at the latest three months after presentation of the programmes. Such guarantees must not exceed those which the Member State implements nationally. 3. Programmes submitted by Member States may be amended or supplemented under the procedure laid down in Article 26. Under the same procedure, amendments may be made to the guarantees referred to in paragraph 2. Article 15 1. Where a Member State considers that its territory or part of its territory is free from one of the diseases listed in Annex B to which the animals covered by this Directive are susceptible, it shall present to the Commission appropriate supporting documentation, setting out in particular: - the nature of the disease and the history of its occurrence in its territory, - the results of surveillance testing based on serological, microbiological, pathological or epidemiological investigation, - the period during which this disease was notifiable to the competent authorities, - the period over which the surveillance was carried out, - where applicable, the period during which vaccination against the disease has been prohibited and the geographical area concerned by the prohibition, - the arrangements for verifying the absence of the disease. 2. The Commission shall examine the documentation provided for in paragraph 1 and submit to the Standing Veterinary Committee a decision approving or rejecting the plan submitted by the Member State. If the plan is accepted, the additional guarantees, general or specific, which may be required in trade shall be defined under the procedure laid down in Article 26. They must not exceed those which the Member State implements nationally. Pending a decision, the Member State concerned may maintain in its trade dealings the relevant requirements needed in order to maintain its status. 3. The Member State concerned shall notify the Commission of any change in the particulars specified in paragraph 1. The guarantees defined as laid down in paragraph 2 may, in the light of such notification, be amended or withdrawn under the procedure laid down in Article 26. CHAPTER III Provisions applicable to imports into the Community Article 16 The conditions applicable to imports of animals, semen, ova and embryos covered by this Directive must be at least equivalent to those laid down in Chapter II. Article 17 1. For the purposes of uniform application of Article 16, the provisions of the following paragraphs shall apply. 2. Only animals, semen, ova and embryos referred to in Article 1 which satisfy the following requirements may be imported into the Community: (a) they must come from a third country on a list to be drawn up in accordance with paragraph 3 (a); (b) they must be accompanied by a health certificate corresponding to a specimen to be drawn up under the procedure laid down in Article 26, signed by the competent authority of the exporting country and certifying that the animals, semen, ova and embryos meet the additional conditions or offer the equivalent guarantees referred to in paragraph 4 and come from approved centres, bodies, institutes or collection centres offering such guarantees. 3. The following shall be established under the procedure laid down in Article 26: (a) without prejudice to the list provided for in Article 6 (A) (1) (e), a provisional list of third countries or parts of third countries able to provide Member States and the Commission, before the date laid down in Article 29, with guarantees equivalent to those provided for in Chapter II and a list of the collection centres for which they are able to give these guarantees. This provisional list shall be compiled from the lists of establishments approved and inspected by the competent authorities once the Commission has checked that these establishments comply with the principles and general rules laid down in this Directive (b) updates of that list in the light of the checks provided for in paragraph 4; (c) the specific animal health requirements - in particular for the protection of the Community from certain exotic diseases - or guarantees equivalent to those provided for in this Directive. The specific requirements and equivalent guarantees established for third countries may not be more favourable than those provided for in Chapter II. 4. The list provided for in paragraph 3 may include only third countrys or parts of third countries: (a) from which imports are not prohibited: - as a result of the existence of one of the diseases referred to in Annex A or of any other disease exotic to the Community, - pursuant to Articles 6, 7 and 14 of Directive 72/462/EEC and Article 17 of Directive 91/495/EEC and of Directive 71/118/EEC (¹) or, in the case of the other animals covered by this Directive, under a decision taken in accordance with the procedure laid down in Article 26 account being taken of their state of health; (b) which, in view of their legislation and the organization of their veterinary services and inspection services, the powers of such services and the supervision to which (¹) Council Directive 71/118/EEC of 15 February 1971 on health problems affecting trade in fresh poultrymeat (OJ No L 55, 8. 3. 1971, p. 23). Last amended by Directive 90/654/EEC (OJ No L 353, 17. 12. 1990, p. 48). they are subject, have been recognized, in accordance with Article 3 (2) of Directive 72/462/EEC, as capable of guaranteeing the implementation of their legislation in force; (c) the veterinary services of which are able to guarantee that health requirements at least equivalent to those laid down in Chapter II are being complied with. 5. Experts from the Commission and the Member States shall carry out on-the-spot inspections to verify whether the guarantees given by the third country regarding the conditions of production and placing on the market can be considered equivalent to those applied in the Community. The experts from the Member States responsible for these inspections shall be appointed by the Commission acting on a proposal from the Member States. These inspections shall be made on behalf of the Community, which shall bear the cost of any expenditure in this connection. 6. Pending the organization of the inspections referred to in paragraph 5, national rules applicable to inspection in third countries shall continue to apply, subject to notification, through the Standing Veterinary Committee, of any failure to comply with the guarantees offered in accordance with paragraph 3, found during these inspections. Article 18 1. Member States shall ensure that the animals, semen, ova and embryos covered by this Directive are imported into the Community only if they: - are accompanied by a certificate to be drawn up by the official veterinarian. The specimen certificate shall, depending on the species, be drawn up under the procedure laid down in Article 26, - have satisfied the checks required by Directives 90/675/EEC and 91/496/EEC (²), - have undergone, prior to shipment to Community territory, a check by an official veterinarian to ensure that the transport conditions specified in Directive 91/628/EEC (³) have been complied with, in particular as regards watering and feeding, - have, in the case of the animals referred to in Articles 5 to 10, been quarantined before being placed on the market, in accordance with detailed rules to be established under the procedure laid down in Article 26. (²) Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directive 89/662/EEC, 90/425/EEC and 90/675/EEC (OJ No L 268, 24. 9. 1991, p. 56). (³) Council Directive 91/628/EEC of 19 November 1991 on the protection of animals during transport and amending Directives 90/425/EEC and 91/496/EEC (OJ No L 340, 11. 12. 1991, p. 17). 2. Pending the establishment of specific rules for this Article, the national rules applicable to imports from third countries for which such requirements have not been adopted at Community level shall continue to apply, provided they are not more favourable than those laid down in Chapter II. Article 19 The following shall be decided under the procedure laid down in Article 26: (a) specific animal health requirements, for imports into the Community, and the nature and content of accompanying documents for animals intended for zoos, circuses, amusement parks or experimental laboratories, according to the species; (b) additional guarantees to those provided for in respect of the various animal species covered by this Directive, to protect the Community species concerned. Article 20 The principles and rules laid down in Directive 90/675/EEC shall apply, with particular reference to the organization of and follow-up to the inspections to be carried out by the Member States and the safeguard measures to be implemented. Pending implementation of the decisions provided for in Article 8 (3) and Article 30 of Directive 91/496/EEC, the relevant national rules for applying Article 8 (1) and (2) of the said Directive shall continue to apply, without prejudice to compliance with the principles and rules referred to in paragraph 1 of this Article. CHAPTER IV Common final provisions Article 21 Any specimens of certificates applicable to trade and the animal health conditions to be met in order for it to be possible to trade in animals, semen, ova and embryos other than those covered by Article 5 to 11 shall, where the need arise, be determined under the procedure laid down in Article 26. Article 22 The Annexes to this Directive shall, where the need arises, be amended under the procedure laid down in Article 26. Article 23 Under the procedure laid down in Article 26, special requirements may be laid down, if appropriate, by way of derogation from Article 6 (A) (1) (e) and from Chapter II, for the movement of circus and fairground animals and for trade in animals, semen, ova and embryos intended for zoos. Article 24 1. The Member States shall be authorized to subject the entry into their territory of the animals (including cage birds), semen, ova and embryos referred to in this Directive which have passed through the territory of a third country to production of a health certificate certifying compliance with the requirements of this Directive. 2. Member States which have recourse to the possibility laid down in paragraph 1 shall inform the Commission and the other Member States within the Standing Veterinary Committee. Article 25 The following shall be added to Annex A to Directive 90/425/EEC: 'Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (1) to Directive 90/425/EEC (OJ No L 268, 14. 9. 1992, p. 54).' Article 26 Where reference is made to the procedure provided for in this Article, the Standing Veterinary Committee set up by Decision 68/361/EEC (¹) shall act in accordance with the rules laid down in Article 17 of Directive 89/662/EEC. Article 27 Member States which implement an alternative control system providing guarantees equivalent to those laid down in this Directive as regards movements within their terrritory of the animals, semen, ova and embryos which it covers, may grant one another derogations from Article 6 (A) (1) (f), Article 8 (b) and Article 11 (1) (d) on a reciprocal basis. Article 28 Under the procedure laid down in Article 26, transitional measures may be adopted for a period of three years to (¹) OJ No L 255, 18. 10. 1968, p. 23. facilitate the transition to the new arrangements established by this Directive. Article 29 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1994. They shall forthwith inform the Commission thereof. When these measures are adopted by the Member States, 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 texts of the main provisions of national law which they adopt in the field governed by this Directive. 3. The setting of the deadline for transposition into national law at 1 January 1994 shall be without prejudice to the abolition of veterinary checks at frontiers provided for in Directive 89/662/EEC and 90/425/EEC. Article 30 This Directive is addressed to the Member States.

31992L0066

1992

Council Directive 92/66/EEC of 14 July 1992 introducing Community measures for the control of Newcastle disease Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 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 poultry is listed in Annex II of the Treaty and whereas the marketing of poultry constitutes an important source of revenue for the agricultural population; Whereas, it is necessary to establish at Community level the control measures to be taken in the event of an outbreak of Newcastle disease in order to ensure development of the poultry sector and contribute to the protection of animal health in the Community; Whereas minimum Community control measures should furthermore be provided for against Newcastle disease to apply to certain other species; Whereas an outbreak of Newcastle disease can quickly take on epizootic proportions, causing mortality and disturbances on a scale liable to reduce sharply the profitability of farming or poultry as a whole; Whereas action must be taken as soon as the presence of the disease is suspected so that immediate and effective control measures can be implemented when its presence is confirmed; whereas such measures must be modulated by the competent authorities to take account of whether or not a country carries out a prophylactic vaccination programme in all or part of its territory; Whereas it is necessary to prevent any spread of the disease as soon as an outbreak occurs, by carefully monitoring movements of animals and the use of products liable to be contaminated, and, where appropriate, by vaccination; Whereas diagnosis of the disease must be carried out under the auspices of responsible national laboratories, the coordination of which must be ensured by a Community reference laboratory; Whereas it is necessary to make provision for the Member States which vaccinate to draw up vaccination plans and to inform the Commission and other Member States about those plans; Whereas Article 4 of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field(4) applies in the event of the occurrence of Newcastle disease; Whereas it is appropriate to confer upon the Commission the task of taking the necessary applicatory measures, Article 1 Without prejudice to the Community provisions governing intra-Community trade, this Directive defines the Community control measures to be applied in the event of an outbreak of Newcastle disease in: (a) poultry; (b) racing pigeons and other birds kept in captivity. This Directive shall not apply where Newcastle disease is detected in wild birds living freely; however, in that case, the Member State concerned shall inform the Commission of any measure it takes. Article 2 For the purpose of this Directive, the definitions given in Article 2 of Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs(5) shall apply as appropriate. The following definitions shall also apply: (a) 'infected poultry' means any poultry: - in which the presence of Newcastle disease has been officially confirmed following an examination by an approved laboratory, or - in the case of second and subsequent outbreaks in which clinical symptoms or post-mortem lesions consistent with Newcastle disease are present; (b) 'poultry suspected of being infected' means any poultry showing clinical signs or post-mortem lesions which are such that the presence of Newcastle disease may reasonably be suspected; (c) 'poultry suspected of being contaminated' means any poultry which may have been directly or indirectly exposed to the Newcastle-disease virus; (d) 'swill' means waste from kitchens, restaurants or, where appropriate, from industries using meat; (e) 'competent authority' means the competent authority within the meaning of Article 2 (6) of Directive 90/425/EEC(6) ; (f) 'official veterinarian' means the veterinarian designated by the competent authority; (g) 'racing pigeon' means any pigeon transported or intended for transport from its pigeon house to be released so that it may freely fly back to its pigeon house or to any other destination; (h) 'pigeon house' means any installation used for keeping or breeding racing pigeons. Article 3 Member States shall ensure that there is compulsory and immediate notification of the suspected presence of Newcastle disease to the competent authority. Article 4 1. When poultry in a holding are suspected of being infected or contaminated with Newcastle disease, Member States shall ensure that the official veterinarian immediately activates official investigation arrangements to confirm or rule out the presence of the disease and, in particular, must take or have taken the samples necessary for laboratory examination. 2. As soon as the suspected infection is notified, the competent authority shall have the holding placed under official surveillance and shall in particular require that: (a) a record be made of all categories of poultry on the holding showing in respect of each of the categories the numbers of poultry which have died, which show clinical signs, and which show no signs. The record shall be kept up-to-date to include birds born or dying during the period in which there is a suspicion. The data in the record shall be kept up-to-date and be produced on request, and may be checked at each visit; (b) all poultry on the holding are kept in their living quarters or confined in some other place where they can be isolated and without contact with other poultry; (c) no poultry enter or leave the holding; (d) all movement - of persons, other animals and vehicles to or from the holding, - of poultry meat or carcasses, or of animal feed, implements, waste, droppings, manure litter or anything liable to transmit Newcastle disease be subject to authorization by the competent authority; (e) no eggs shall leave the holding with the exception of eggs sent directly to an establishment approved for the manufacture and/or processing of egg products under Article 6 (1) of Directive 89/437/EEC(7) , and transported under an authorization which has been granted by the competent authority. Such authorization must meet the requirements laid down in Annex 1; (f) appropriate means of disinfection be installed at the entrances and exits of buildings housing poultry and of the holding itself; (g) an epizootiological inquiry be carried out in accordance with Article 7. 3. Until such time as the official measures laid down in paragraph 2 are enforced, the owner or keeper of any poultry in which disease is suspected shall take all reasonable action to ensure compliance with paragraph 2, except for (g) thereof. 4. The competent authority may apply any of the measures provided for in paragraph 2 to other holdings should their location, their configuration or contacts with the holding where the disease is suspected give reason to suspect possible contamination. 5. The measures referred to in paragraphs 1 and 2 shall not be withdrawn until the suspicion of Newcastle disease has been ruled out by the official veterinarian. Article 5 1. Once the presence of Newcastle disease in poultry has been officially confirmed on a holding, the Member States shall ensure that the competent authority requires, in addition to the measures listed in Article 4 (2), the following measures to be untertaken: (a) all poultry on the holding shall without delay be killed on the spot. The poultry which have died or been killed and all eggs shall be destroyed. These operations shall be carried out in a way which minimizes the risk of spreading disease; (b) any substance or waste, such as animal feed, litter or manures liable to be contaminated, shall be destroyed or treated appropriately. This treatment, carried out in accordance with the instructions of the official veterinarian, shall ensure the destruction of any Newcastle-disease virus present; (c) where poultry from the holding have been slaughtered during the presumed incubation period of disease the meat from those poultry shall wherever possible be traced and destroyed; (d) hatching eggs laid during the presumed incubation period which have been moved from the holding shall be traced and destroyed; but poultry which have already hatched from the eggs shall be placed under official surveillance; table eggs laid during the presumed incubation period which have been moved from the holding shall wherever possible be traced and destroyed, unless they have previously been properly disinfected; (e) after carrying out operations listed under (a) and (b), the buildings used for housing poultry, their surroundings, the vehicles used for transport and all equipment likely to be contaminated shall be cleaned and disinfected in accordance with the provisions of Article 11; (f) no poultry shall be reintroduced to the holding until at least 21 days after completion of operations provided for under (e); (g) an epizootiological inquiry shall be carried out in accordance with Article 7. 2. The competent authority may extend the measures provided for in paragraph 1 to other neighbouring holdings should their location, their configuration, or contact with the holding where the disease has been confirmed give reason to suspect possible contamination. 3. Where a strain of Newcastle-disease virus with an ICPI (intracerebral pathogenicity index) greater than 0,7 and lower than 1,2 is isolated in a flock of poultry that presents no clinical signs of Newcastle disease and it has been demonstrated by the Community reference laboratory referred to in Article 15 that the virus isolate in question derives from an atenuated live Newcastle-disease vaccine, the competent authority may grant a derogation from the requirements under (a) to (f), of paragraph 1, provided that the holding concerned is placed under official surveillance for 30 days and must require in particular that: - the provisions of Article 4 (2) (a), (b), (d), (e) and (f) are applied, - no poultry may leave the holding except to be taken directly to a slaughterhouse designated by the competent authority. The competent authority responsible for this slaughterhouse must be informed of the intention to send poultry there for slaughter and as soon as the poultry arrive at the slaughterhouse they shall be kept and slaughtered separately from other poultry. 4. Fresh meat from the poultry referred to in paragraph (3) of this Article must carry the health mark provided for in Article 5 (1) of Directive 91/494/EEC. 5. The provisions laid down in paragraph 3 shall be subject to a review taking into account developments in scientific research with a view to adopting harmonized rules for the use of Newcastle-disease vaccines in the Community. Article 6 In the case of holdings which consist of two or more separate flocks, the competent authority may, in accordance with criteria set by the Commission under the procedure laid down in Article 25, grant a derogation from the requirements of Article 5 (1), for healthy flocks of a holding which is infected, provided that the official veterinarian has confirmed that the operations carried out there are such that the flocks are completely separate as regards housing, keeping and feeding, so that the virus cannot spread from one flock to another. Article 7 1. The epizootiological inquiry shall deal with: - the length of time during which Newcastle disease may have existed on the holding or in the pigeon house; - the possible origin of the Newcastle disease on the holding or in the pigeon house and the identification of other holdings or pigeon houses in which there are poultry, pigeons or other birds kept in captivity which may have become infected or contaminated from the same source; - the movement of persons, poultry, pigeons or other birds kept in captivity or other animals, vehicles, eggs, meat and carcases and any implement or substance likely to have carried Newcastle-disease virus to or from the holding or pigeon house in question. 2. In order to provide full coordination of all measures necessary to ensure eradication of Newcastle disease as quickly as possible and for the purpose of carrying out the epizootiological inquiry, a crisis unit shall be established. The general rules concerning national crisis units and Community crisis units will be laid down by the Council, acting by a qualified majority proposal from the Commission. Article 8 1. Where the official veterinarian has reason to suspect that poultry on any holding may have been contaminated as a result of the movement of persons, animals or vehicles or in any other way, that holdings shall be placed under official control in accordance with paragraph 2. 2. The purpose of the official control shall be to detect immediately any suspicion of Newcastle disease, count the poultry and monitor their movements and, where appropriate, to take the action provided for in paragraph 3. 3. When a holding is subject to official control under paragraphs 1 and 2, the competent authority shall prohibit removal of poultry from the holding other than for transport directly to a slaughterhouse under official supervision for the purpose of immediate slaughter. Before granting such authorization, the official veterinarian must have carried out a clinical examination of all the poultry to exclude presence of Newcastle disease on the holding. The movement restrictions referred to in this Article shall be imposed for a period of 21 days from the latest date of potential contamination; however, such restrictions must apply for a period of at least seven days. 4. Where it considers that conditions permit, the competent authority may limit the measures provided for in this Article to a part of the holding and to the poultry contained therein, provided that the poultry there have been housed, kept and fed completely separately be separate staff. 5. Where the official veterinarian has reason to suspect racing pigeons or any pigeon house of being contaminated by the Newcastle-disease virus, he shall take all appropriate steps to ensure that the pigeon house is subject to restrictions, including a ban on all movement of racing pigeons outside the pigeon house for 21 days. Article 9 1. Once the diagnosis of Newcastle disease has been officially confirmed in poultry, the Member States shall ensure that the competent authority establishes around the infected holding a protection zone based on a minimum radius of three kilometres, itself contained in a surveillance zone based on a minimum radius of 10 kilometres. The establishment of the zones must take account of geographical, administrative, ecological and epizootiological factors relating to Newcastle disease, and of monitoring facilities. 2. The measures applied in the protection zone shall include: (a) the identification of all holdings having poultry within the zone; (b) periodic visits to all the holdings having poultry, a clinical examination of those poultry including, if necessary, the collection of samples for laboratory examination; a record of visits and findings must be kept; (c) the keeping of all poultry in their living quarters or some other place where they can be isolated; (d) the use of appropriate means of disinfection at the entrances and exits of the holding; (e) the control of movements or persons handling poultry, poultry carcases and eggs and vehicles carrying poultry, carcases and eggs within the zone; in general, transport of poultry shall be prohibited, except for transit by major highways or railways; (f) a prohibition on removing poultry and hatching eggs from the holding on which they are kept unless the competent authority has authorized the transport; (i) of poultry for immediate slaughter to a slaughterhouse preferably located in the infected area or, if that is not possible, to a slaughterhouse designated by the competent authority outside the infected area. The special health mark provided for in Article 5 (1) of Directive 91/494/EEC(8) must be applied to this poultry meat; (ii) of day-old chicks or ready-to-lay pullets to a holding within the surveillance zone at which there are no other poultry. However, the Member States, that are not in a position to be able to provide transport of day-old chicks or ready-to-lay pullets to a holding situated within the surveillance zone, shall be authorized, in accordance with the procedure laid down in Article 25, to have the said chicks and pullets transported to a holding outside the surveillance zone. The holdings referred to above must be placed under official control in accordance with Article 8 (2); (iii) of hatching eggs to a hatchery designated by the competent authority; before dispatch, eggs and their packing must be disinfected. Movements allowed in (i), (ii) and (iii) shall be directly executed, under official control. They shall be authorized only after the official veterinarian has carried out a health inspection of the holding. The means of transport used must be cleaned and disinfected before and after use; (g) a prohibition on removing or spreading used litter or poultry manure without authorization; (h) the prohibition of fairs, markets, shows or other gatherings of poultry or other birds. 3. The measures applied in the protection zone shall be maintained for at least 21 days after the carrying out of preliminary cleaning and disinfection operations on the infected holding in accordance with Article 11. The protection zone shall thereafter be part of the surveillance zone. 4. The measures applied in the surveillance zone shall include: (a) the identification of all holdings having poultry within the zone; (b) the control of poultry and hatching egg movement within the zone; (c) a prohibition on the movement of poultry out of the zone during the first 15 days, except for movement directly to a slaughterhouse outside the surveillance zone designated by the competent authority. The special health mark provided for in Article 5 of Directive 91/494/EEC must be applied to this poultry meat; (d) a prohibition on the movement of hatching eggs out of the surveillance zone unless to a hatchery designated by the competent authority. Before dispatch the eggs and their packing must be disinfected; (e) a prohibition on the movement of used litter or poultry manure out of the zone; (f) a prohibition of fairs, markets, shows or other gatherings of poultry and other birds; (g) without prejudice to the provisions of (a) and (b), the prohibition of transport of poultry except for transit by major highways or railways. 5. The measures applied in the surveillance zone shall be maintained for at least 30 days after the carrying out of preliminary cleaning and disinfection operations on the infected holding in accordance with Article 11. 6. Where the zones are situated in the territory of more than one Member State, the competent authorities of the Member States concerned shall cooperate in establishing the areas described in paragraph 1. However, if necessary, the protection zone and the surveillance zone shall be established by the procedure provided for in Article 25. 7. Where the epizootiological enquiry referred to in Article 7 confirms that the outbreak is due to an infection where there is no evidenc of lateral spread, the size and duration of the protection and surveillance zones may be reduced under the procedure laid down in Article 25. Article 10 Member States shall ensure that: (a) the competent authority determines the arrangements allowing them to trace the movement of eggs, poultry and birds kept in captivity; (b) the owner or keeper of poultry and/or racing pigeons and/or birds kept in captivity is required to supply the competent authority, in response to any request by that authority, with information concerning poultry and eggs entering or leaving his holding, as well as information on the races or shows in which the racing pigeons have taken part; (c) all persons engaged in the transport or marketing of poultry, eggs, racing, pigeons and birds kept in captivity are able to supply the competent authority with information concerning the movements of poultry, eggs, racing pigeons and birds kept in captivity which they have transported or marketed and to furnish all the details concerning such information. Article 11 Member States shall ensure that: (a) the disinfectants to be used and their concentrations are officially approved by the competent authority; (b) the cleaning and disinfection operations are carried out under official supervision, in accordance with: (i) instructions given by the official veterinarian; (ii) the procedure for cleaning and disinfecting an infected holding, as laid down in Annex II. Article 12 Collection of samples and laboratory testing to detect the presence of Newcastle-disease virus shall be carried out in accordance with Annex III. Article 13 Member States shall ensure that the competent authority takes all the necessary measures for persons established in the protection and surveillance zones to be informed of the restrictions in force and make all necessary arrangements for the appropriate implementation of the measures in question. Article 14 1. Member States shall ensure that, in each Member State there is designated: (a) a national laboratory at which facilities and expert personnel shall be maintained to permit full antigenic and biological typing of Newcastle-disease virus at all times and to confirm results obtained in regional diagnostic laboratories; (b) a national laboratory at which reagents for use in regional laboratories are tested; (c) a national institute or laboratory at which vaccines allowed for prohpylactic use in the country or stock-piled for emergency use may be tested for efficacy, potency and purity. 2. The national laboratories listed in Annex IV shall be responsible for coordinating standards and methods of diagnosis, use of reagents and testing of vaccines. 3. The national laboratories listed in Annex IV shall be responsible for coordinating the standards and diagnostic methods laid down in each Newcastle-disease diagnostic laboratory within the Member State. To this end: (a) they may provide diagnostic reagents to national laboratories; (b) they shall control the quality of all diagnostic reagents used in that Member State; (c) they shall arrange comparative tests periodically; (d) they shall hold isolates of Newcastle-disease virus from cases confirmed in that Member State; (e) they shall ensure the confirmation of positive results obtained in regional diagnostic laboratories. 4. The national laboratories listed in Annex IV shall liaise with the Community reference laboratory referred to in Article 15. Article 15 The Community reference laboratory for Newcastle disease is mentioned in Annex V. Without prejudice to the provisions of Decision 90/424/EEC(9) , and in particular Article 28 thereof, the powers and duties of the laboratory shall be those appearing in the said Annex. Article 16 1. Member States shall ensure that: (a) vaccination against Newcastle disease with vaccines authorized by the competent authority may be used for a prophylactic purpose or to supplement the control measures carried out when the disease appears; (b) the only vaccines allowed are those which have received a marketing authorization from the competent authority of the Member State in which the vaccine is used. 2. Further criteria for using vaccines against Newcastle disease may be established in accordance with the procedure laid down in Article 25. Article 17 1. A Member State in which voluntary or compulsory prophylactic vaccination against Newcastle disease is carried out shall inform the Commission and the other Member States. 2. The information given in accordance with paragraph 1 must specify: - the characteristics and composition of the vaccine to be used; - the procedures for supervision of the distribution, storage and use of vaccines; - the species and categories of poultry which may or shall be subject to vaccination; - the areas in which vaccination may or shall be carried out; - the reasons for which vaccination is carried out. 3. Member States may provide for the establishment of a vaccination programme for racing pigeons. Where this is the case, they must notify the Commission. Without prejudice to such a programme, the Member States shall ensure that the organizers of races and shows take the necessary steps so that only racing pigeons which have been vaccinated against Newcastle disease may be entered in races and shows. 4. The detailed rules for applying this Article, in particular with respect to the criteria to be adopted, and any derogations that may be granted taking into account the health status of the Member States shall be fixed in accordance with the procedure laid down in Article 25. Article 18 1. Member States shall ensure that, when Newcastle disease has been confirmed, the competent authority, in order to supplement the other control measures provided for in this Regulation, is able to specify a territorial area and period in which the prompt and systematic vaccination (emergency vaccination) of designated species of poultry shall be carried out under official control. A Member State applying emergency vaccination shall inform the Commission and other Member States within the framework of the standing veterinary committee, set up by Decision 68/361/EEC(10) , about the Newcastle-disease situation and emergency vaccination programme. 2. In the case referred to in paragraph 1, the vaccination or re-vaccination of poultry on the holding subject to the restrictions referred to in Article 4 is prohibited. 3. In the case referred to in paragraph 1: (a) the designated species of poultry shall be vaccinated as soon as possible; (b) all poultry of designated species born on or transferred to a holding inside the vaccination area must be or have been vaccinated; (c) throughout the vaccination operation provided for in paragraph 1 all poultry of designated species kept on holdings inside the vaccination area must remain there except: - day-old chicks moved to a holding inside the vaccination area where they shall be vaccinated; - poultry moved direct to a slaughterhouse for immediate slaughter. If the slaughterhouse is located outside the vaccination area the movement of poultry shall be permitted only after the official veterinarian has carried out a health inspection of the holding; (d) when the vaccination operations provided for in (a) have been completed movements out of the vaccination area may be authorized for: - day-old chicks intended for meat production may be moved to a holding where they shall be vaccinated; the holding in question must be kept under surveillance until the poultry which have been moved have been slaughtered; - poultry vaccinated more than 21 days previously and intended for immediate slaughter; - hatching eggs which originate from breeding poultry vaccinated at least 21 days previously; the eggs and their packing must be disinfected before movement. 4. The measures provided for in (b) and (d) of paragraph 3 shall be applied for a period of three months following completion of vaccination operations provided for in paragraph 1; they may be extended for one or more additional periods of three months. 5. By way of derogation from (a) and (b) of paragraph 3, the competent authorities may exempt certain flocks of particular scientific value from systematic vaccination, provided that all necessary steps are taken by the competent authority to ensure protection of their health and to subject them to periodic serological checks. 6. The Commission shall follow the development of the disease situation and if necessary it may, in accordance with the procedure laid down in Article 25, take a decision in particular in relation to control of movement and vaccination. Article 19 1. Where carrier pigeons or birds kept in captivity are suspected of being infected with Newcastle disease, Member States shall ensure that the official veterinarian immediately starts the official investigation procedures for confirming or notifying the presence of the disease; in particular, he shall take adequate samples for laboratory examination or see that they are taken. 2. As soon as it has been notified of the suspicion, the competent authority shall place the holding or pigeon house under official surveillance and order that no pigeon or bird kept in captivity, and nothing likely to transmit Newcastle disease, may leave the pigeon house or holding. 3. The measures provided for in paragraphs 1 and 2 shall not be withdrawn until the suspicion of Newcastle disease has been ruled out by the official veterinarian. 4. As soon as the presence of Newcastle disease has been officially confirmed, the competent authority shall, inter alia, order: (a) application of the control and eradication measures provided for in Article 5 (1) (a), (b), (e) and (f) to the carrier pigeons or birds kept in captivity and pigeon houses infected with Newcastle disease; or (b) at least (i) a ban on movement of the pigeons or birds kept in captivity outside the pigeon house or holding for at least 60 days after the clinical signs of Newcastle disease have disappeared; (ii) destruction or treatment of any matter or waste likely to be contaminated. Treatment must guarantee the destruction of any Newcastle-disease virus present and all waste that has accumulated during the 60-day period referred to in (i); (c) an epizootiological inquiry in accordance with Article 7. 5. To the extent that it is required for the proper application of the provisions laid down in this Article, the Member States shall furnish to the Commission, within the Standing Veterinary Committee, information on the situation of the disease and the control measures applied in accordance with the model appearing in Annex VI. Article 20 1. The use of swill originating from means of international transport, such as ships, land vehicles or aircraft, shall be prohibited for the feeding of poultry; such swill shall be collected and destroyed under official supervision. 2. The use of swill other than as defined in paragraph 1, or poultry scraps, may be authorized for the feeding of poultry only after a heat-treatment in appropriate facilities ensuring that the disease is not transmitted and the Newcastle-disease virus is destroyed. 3. If necessary, the Commission shall, in accordance with the procedure laid down in Article 25, lay down the detailed rules for the implementation of paragraph 2. Article 21 1. Each Member State shall draw up a contigency plan, specifying the national measures to be implemented in the event of an outbreak of Newcastle disease. This plan must allow access to facilities, equipment, personnel and all other appropriate materials necessary for the rapid and efficient eradication of the outbreak. It must give a precise indication of the vaccine requirements which each Member State deems necessary for emergency vaccination. 2. The criteria to be applied for drawing up the plan are laid down in Annex VII. 3. Plans drawn up in accordance with the criteria listed in Annex VII shall be submitted to the Commission not later than six months after this Directive is brought into application. 4. The Commission shall examine the plans in order to determine whether they permit the desired objective to be attained and shall suggest to the Member State concerned any amendments required in particular to ensure that they are compatible with those of the other Member States. The Commission shall approve the plans, if necessary amended, in accordance with the procedure laid down in Article 25. The plans may subsequently be amended or supplemented, in accordance with the same procedure, to take into account developments in the situation. Article 22 Commission experts may, in collaboration with the competent authorities, and insofar as is necessary to ensure uniform application of this Directive, make on-the-spot checks. In order to do this, they may check a representative percentage of establishments to see whether the competent authorities are checking that these establishments are fulfilling the requirements of this Directive. The Commission shall inform the Member States of the result of the checks carried out. A Member State in whose territory a check is being carried out shall give all the necessary assistance to the experts in carrying out their duties. The general provisions for implementing this Article shall be determined in accordance with the procedure laid down in Article 25. Article 23 The detailed conditions governing the Community's financial contribution to the measures connected with the application of this Directive are laid down in Decision 90/424/EEC. Article 24 The Annexes shall be amended, as and when required, by the Council acting by a qualified majority acting on a proposal from the Commission, in particular in order to take into account developments in research and in diagnostic procedures. Article 25 1. Where the procedure laid down in this Article is to be followed, the Standing Veterinary Committee, set up by Decision 68/361/EEC, hereinafter referred to as 'the Committee', shall be informed without delay by its Chairman either on his own initiative or at the request of the 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 deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. (b) If 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 relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority. Article 26 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 October 1993. 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 dwon by the Member States. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. Article 27 This Directive is addressed to the Member States.

31992L0069

1992

Commission Directive 92/69/EEC of 31 July 1992 adapting to technical progress for the seventeenth time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as last amended by Directive 92/32/EEC (2), and in particular Articles 28 and 29 thereof, (1) OJ No 196, 16. 8. 1967, p. 1. (2) OJ No L 154, 5. 6. 1992, p. 1. Whereas Article 3 (1) of Directive 67/548/EEC and Article 3 of Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous preparations (3), as last amended by Commission Directive 90/492/EEC (4), provide that the physico-chemical properties, toxicity and ecotoxicity of substances and preparations shall be determined according to the methods specified in Annex V of Directive 67/548/EEC; (1) OJ No 196, 16. 8. 1967, p. 1. (3) OJ No L 187, 16. 7. 1988, p. 14. (4) OJ No L 275, 5. 10. 1990, p. 35. Whereas the text of Annex V to Directive 67/548/EEC is currently published in two parts, these respectively being the Annex to Commission Directive 84/449/EEC (5), and the Annex to Commission Directive 88/302/EEC (6); (5) OJ No L 251, 19. 9. 1984, p. 1. (6) OJ No L 133, 30. 5. 1988, p. 1 and OJ No L 136, 2. 6. 1988, p. 20. Whereas, in order to take account of technical developments it is necessary to revise the test methods to be found in the Annex to Commission Directive 84/449/EEC; Whereas, in order to take account of technical developments it is also necessary to revise the test method for the algal inhibition test currently to be found in the Annex to Commission Directive 88/302/EEC and on this occasion to transfer this test method to the Annex to Directive 84/449/EEC; Whereas it is appropriate to reduce to a minimum the number of animals used for experimental purposes, in accordance with Council Directive 86/609/EEC on the approximation of the laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental purposes (7); (7) OJ No L 358, 18. 12. 1986, p. 1. Whereas the provisions of this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in Dangerous Substances and Preparations, Article 1 The Annex to Directive 84/449/EEC is hereby replaced by the Annex to the present Directive. Article 2 The algal inhibition test method described to the Annex to Directive 88/302/EEC is hereby deleted. Article 3 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 October 1993. Member States shall immediately inform the Commission thereof. When Member States adopt these provisions these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States. Article 4 This Directive is addressed to the Member States.

31992L0072

1992

Council Directive 92/72/EEC of 21 September 1992 on air pollution by ozone Having regard to the Treaty establishing the European Economic Community, and in particular Article 130s 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 the 1987 fourth Community action programme on the environment (4) provides for the possibility of action on photochemical pollution, and in particular pollution by ozone, in view of its harmful effects and the state of knowledge concerning its impact on human health and the environment; Whereas, in order to protect human health, ozone concentrations in the air should be limited; whereas scientific and technical information needs to be utilized and promoted in order to obtain wider knowledge of this form of pollution and, in future, take effective and appropriate measures to reduce it; Whereas as complete a knowledge as possible of ozone pollution levels is required in all Member States; Whereas to obtain this knowledge it is necessary to set up measurement stations to provide data on ozone concentrations in the air; Whereas in order to obtain results which are comparable in the context of this Directive, the methods used by Member States to determine concentrations need to be equivalent; Whereas, in view of the special nature of photochemical pollution, the reciprocal exchange of information between Member States and the Commission including, once it is effectively set up, the European Environment Agency (5), is essential for a better understanding of the problem; Whereas the setting of information or warning thresholds at which precautions should be taken by the public will make it possible to limit the impact of pollution episodes on health; Whereas the numerical values of these levels should be based on the findings of work carried out in the framework of the World Health Organization (WHO), in particular as regards the dose-effect relationships established for the pollutant in question; Whereas the information collected under this Directive should be regularly evaluated to make it possible to monitor the development of air pollution by ozone and the impact of national and Community provisions to reduce photochemical precursors and establish in the future new provisions concerning ozone and air quality; whereas such evaluation and information should be the subject of a report to be submitted by the Commission as soon as possible and by the end of a period of four years from the date of implementation of this Directive at the latest; Whereas combating air pollution by ozone may also entail measures to reduce ozone precursors; whereas the Commission must therefore also submit, with the abovementioned report, proposals for controlling air pollution by ozone and, if necessary, reducing emissions of ozone precursors; Whereas action by the Community and Member States against photochemical pollution should be coordinated in order for maximum effect to be achieved, Article 1 1. The purpose of this Directive is to establish a harmonized procedure: - for monitoring, - for exchanging information, - for informing and warning the population, with regard to air pollution by ozone in order to enable the competent authorities of the Member States and the Commission to obtain wider knowledge of this form of air pollution in the Community, optimize the action needed to reduce ozone formation and guarantee a minimum amount of public information where concentration thresholds as referred to in points 3 and 4 of Annex I are exceeded. 2. For the purposes of this Directive: - health protection threshold means the ozone concentration value given in Annex I, point 1, which should not be exceeded if human health is to be safeguarded in the event of prolonged pollution episodes, - vegetation protection thresholds means the ozone concentration values given in Annex I, point 2, beyond which vegetation may be affected, - population information threshold means the ozone concentration value given in Annex I, point 3, beyond which there are limited, temporary effects on human health in the event of short exposure of particularly sensitive sections of the population and at which steps must be taken by the Member States as laid down in this Directive, - population warning threshold means the ozone concentration value given in Annex I, point 4, beyond which there is a risk to human health in the event of short exposure and at which steps must be taken by the Member States as laid down in this Directive. Article 2 Each Member State shall designate a body to inform the Commission and to coordinate the implementation of the harmonized procedure set out in Article 1 (1), and shall forthwith inform the Commission thereof. Article 3 Member States shall where appropriate designate or establish measuring stations to supply the data necessary for the implementation of this Directive. The number and the location of these stations shall be determined by Member States in compliance with Annex II. Article 4 1. For the measurement of ozone concentrations, Member States shall use: - either the reference method specified in Annex V, - or any other method of analysis shown to produce measurement results equivalent to those obtained using the reference method. To this end, each Member State shall designate one or more laboratories responsible for evaluating the method used at national level in relation to the reference method in this Directive. Furthermore, they shall organize at national level intercomparisons between laboratories taking part in the collection and analysis of the data. 2. Once the measuring stations have been established, Member States shall provide the Commission with the following information: - the method used to determine ozone concentrations and, if it is different from the reference method in this Directive, proof of its equivalence with the latter, - the geographical coordinates of the measuring stations, a description of the area covered by the stations, and the site-selection criteria, - the results of any indicative measurement programmes carried out under the provisions of Annex II, point 2. 3. The Commission may organize, on a Community scale, intercomparison programmes between laboratories referred to in paragraph 1. Article 5 In the event of the values given in Annex I, points 3 and 4, being exceeded, the Member States shall take the necessary steps for the public to be informed (e.g. by means of radio, television and the press), in accordance with Annex IV. Article 6 1. As from 1 January 1995, Member States shall provide the Commission with the following information no later than six months following the annual reference period: - the maximum, the median and the 98th percentile of the mean values over one hour and eight hours recorded during the year in each measuring station; the percentiles shall be calculated in accordance with the method given in Annex III, - the number, date and duration of periods during which the thresholds laid down in Annex I, points 1 and 2, are exceeded. A Member State may additionally submit information based on percentile 99,9. 2. Where the information threshold laid down in Annex I, point 3, is exceeded in the course of a calendar month, Member States shall inform the Commission by the end of the following month at the latest, of: - the date(s) of occurrence(s), - the duration thereof, - the maximum hourly concentration recorded during each occurrence. 3. Where the warning threshold laid down in Annex I, point 4, is exceeded in the course of a week (from Monday to the following Sunday), Member States shall inform the Commission, by the end of the following month at the latest, of: - the date(s) of the occurrence(s), - the duration, - the maximum hourly concentration during each occurrence. This information shall be supplemented by relevant data which might explain the reasons for the occurrence. 4. Where the data referred to in paragraphs 1, 2 and 3 are available in the Member States for periods preceding the date referred to in Article 9, Member States shall send them to the Commission at the latest when they send the data relating to the first reference period. The duration of the reference period shall not exceed five years. 5. All the data referred to in paragraphs 1 to 4 shall be forwarded by the Commission to the European Environment Agency as soon as it is operational. Article 7 The Commission shall regularly, and in any event at least once a year, evaluate the data collected under this Directive. The findings of that evaluation shall be forwarded to the Member States. In order to coordinate actions by the Community and the Member States against photochemical pollution, the Commission shall organize, together with Member States, which shall involve the responsible body referred to in Article 2, consultations on the problem of photochemical air pollution, relating in particular to: - the development of ozone concentrations throughout the Member States and whether any of the episodes recorded are of a transboundary nature, - measures and programmes planned by the Member States to reduce air pollution by ozone, - experience and knowledge concerning the problem of photochemical pollution. Article 8 As soon as possible and no later than the end of a four-year period following the implementation of this Directive, the Commission shall submit to the Council a report on the information collected and on the evaluation of photochemical pollution in the Community. This report shall be accompanied by any proposals the Commission deems appropriate on the control of air pollution by ozone and, if necessary, for reducing emissions of ozone precursors. Article 9 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 18 months after its adoption. They shall forthwith inform the Commission thereof. When Member States adopt such provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference at the time of their official publication. The procedures for making such a reference shall be laid down by the Member States. Article 10 This Directive is addressed to the Member States.

31992L0073

1992

Council Directive 92/73/EEC of 22 September 1992 widening the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to medicinal products and laying down additional provisions on homeopathic medicinal products 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 differences currently existing between the provisions laid down by law, regulation or administrative action in the Member States may hinder trade in homeopathic medicinal products within the Community and lead to discrimination and distortion of competition between manufacturers of these products; Whereas the essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health; Whereas, despite considerable differences in the status of alternative medicines in the Member States, patients should be allowed access to the medicinal products of their choice, provided all precautions are taken to ensure the quality and safety of the said products; Whereas the anthroposophic medicinal products described in an official pharmacopoeia and prepared by a homeopathic method are to be treated, as regards registration and marketing authorization, in the same way as homeopathic medicinal products; Whereas the provisions of Directive 65/65/EEC (4) and the Second Directive 75/319/EEC (5), are not always appropriate for homeopathic medicinal products; Whereas homeopathic medicine is officially recognized in certain Member States but is only tolerated in other Member States; Whereas, even if homeopathic medicinal products are not always officially recognized, they are nevertheless prescribed and used in all Member States; Whereas it is desirable in the first instance to provide users of these medicinal products with a very clear indication of their homeopathic character and with sufficient guarantees of their quality and safety; Whereas the rules relating to the manufacture, control and inspection of homeopathic medicinal products must be harmonized to permit the circulation throughout the Community of medicinal products which are safe and of good quality; Whereas, having regard to the particular characteristics of these medicinal products, such as the very low level of active principles they contain and the difficulty of applying to them the conventional statistical methods relating to clinical trials, it is desirable to provide a special, simplified registration procedure for those traditional homeopathic medicinal products which are placed on the market without therapeutic indications in a pharmaceutical form and dosage which do not present a risk for the patient; Whereas, however, the usual rules governing the authorization to market medicinal products should be applied to homeopathic medicinal products placed on the market with therapeutic indications or in a form which may present risks which must be balanced against the desired therapeutic effect; whereas, in particular, those Member States which have a homeopathic tradition should be able to apply particular rules for the evaluation of the results of tests and trials intended to establish the safety and efficacy of these medicinal products provided that they notify them to the Commission, CHAPTER I Scope Article 1 1. For the purposes of this Directive, 'homeopathic medicinal product' shall mean any medicinal product prepared from products, substances or compositions called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in absence thereof, by the pharmacopoeias currently used officially in the Member States. 2. A homeopathic medicinal product may also contain a number of principles. Article 2 1. The provisions of this Directive shall apply to homeopathic medicinal products for human use, to the exclusion of homeopathic medicinal products prepared in accordance with a magistral or an officinal formula as defined in Article 1 (4) and (5) of Directive 65/65/EEC and of homeopathic medicinal products which satisfy the criteria laid down in Article 2 (4) of the said Directive. 2. The medicinal products referred to in paragraph 1 shall be identified by a reference on their labels, in clear and legible form, to their homeopathic nature. CHAPTER II Manufacture, control and inspection Article 3 The provisions of Chapter IV of Directive 75/319/EEC shall apply to the manufacture, control, import and export of homeopathic medicinal products. Article 4 The supervision measures and the sanctions provided for in Chapter V of Directive 75/319/EEC shall apply to homeopathic medicinal products, together with Articles 31 and 32 of the same Directive. However, the proof of therapeutic efficacy referred to in Article 28 (1) (b) of the same Directive shall not be required for homeopathic medicinal products registered in accordance with Article 7 of this Directive or, where appropriate, admitted in accordance with Article 6 (2). Article 5 Member States shall communicate to each other all the information necessary to guarantee the quality and safety of homeopathic medicinal products manufactured and marketed within the Community, and in particular the information referred to in Articles 30 and 33 of Directive 75/319/EEC. CHAPTER III Placing on the market Article 6 1. Member States shall ensure that homeopathic medicinal products manufactured and placed on the market within the Community are registered or authorized in accordance with Articles 7, 8 and 9. Each Member State shall take due account of registrations and authorizations previously granted by another Member State. 2. A Member State may refrain from establishing a special, simplified registration procedure for the homeopathic medicinal products referred to in Article 7. A Member State applying this provision shall inform the Commission accordingly. The Member State concerned shall, by 31 December 1995 at the latest, allow the use in its territory of homeopathic medicinal products registered by other Member States in accordance with Articles 7 and 8. 3. Advertising of the homeopathic medicinal products referred to in paragraph 2 of this Article and in Article 7 (1) shall be subject to the provisions of Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use (¹), with the exception of Article 2 (1) of that Directive. However, only the information specified in Article 7 (2) may be used in the advertising of such medicinal products. Moreover, each Member State may prohibit in its territory any advertising of the homeopathic medicinal products referred to in paragraph 2 and in Article 7 (1). Article 7 1. Only homeopathic medicinal products which satisfy all of the following conditions may be subject to a special, simplified registration procedure: - they are administered orally of externally, - no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto, - there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the medicinal product may not contain either more than one part per 10 000 of the mother tincture or more than 1/100th of the smallest dose used in allopathy with regard to active principles whose presence in an allopathic medicinal product results in the obligation to submit a doctor's prescription. At the time of registration, Member States shall determine the classification for the dispensing of the medicinal product. 2. In addition to the clear mention of the words 'homeopathic medicinal product', the labelling and, where appropriate, package insert for the medicinal products referred to in paragraph 1 shall bear the following, and no other, information: - the scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia used in accordance with Article 1 (1), - name and address of the person responsible for placing the product on the market and, where appropriate, of the manufacturer, - method of administration and, if necessary, route, - expiry date, in clear terms (month, year), - pharmaceutical form, - contents of the sales presentation, - special storage precautions, if any, - a special warning if necessary for the medicinal product, - manufacturer's batch number, - registration number, - 'homeopathic medicinal product without approved therapeutic indications', - a warning advising the user to consult a doctor if the symptoms persist during the use of the medicinal product. 3. Notwithstanding paragraph 2, Member States may require the use of certain types of labelling in order to show: - the price of the medicinal product, - the conditions for refunds by social security bodies. 4. The criteria and rules of procedure provided for in Articles 5 to 12 of Directive 65/65/EEC shall apply by analogy to the special, simplified registration procedure for homeopathic medicinal products, with the exception of the proof of therapeutic efficacy. Article 8 An application for special, simplified registration submitted by the person responsible for placing the product on the market may cover a series of medicinal products derived from the same homeopathic stock or stocks. The following documents shall be included with the application in order to demonstrate, in particular, the pharmaceutical quality and the batch-to-batch homogeneity of the products concerned: - scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered, - dossier describing how the homeopathic stock or stocks is/are obtained and controlled, and justifying its/their homeopathic nature, on the basis of an adequate bibliography, - manufacturing and control file for each pharamceutical form and a description of the method of dilution and potentization, - manufacturing authorization for the medicinal product concerned, - copies of any registrations or authorizations obtained for the same medicinal product in other Member States; - one or more specimens or mock-ups of the sales presentation of the medicinal products to be registered, - data concerning the stability of the medicinal product. Article 9 1. Homeopathic medicinal products other than those referred to in Article 7 of this Directive shall be authorized and labelled in accordance with Articles 4 to 21 of Directive 65/65/EEC including the provisions concerning proof of therapeutic effect and Articles 1 to 7 of Directive 75/319/EEC. 2. A Member State may introduce or retain in its territory specific rules for the pharmacological and toxicological tests and clinical trials of homeopathic medicinal products other than those referred to in Article 7 (1) in accordance with the principles and characteristics of homeopathy as practised in that Member State. In this case, the Member State concerned shall notify the Commission of the specific rules in force. CHAPTER IV Final provisions Article 10 1. Member States shall take the measures necessary to comply with this Directive by 31 December 1993. They shall forthwith inform the Commission thereof. When Member States adopt the said measures, they shall contain a reference to this Directive or be accompanied by such reference when they are officially published. The procedure for making such reference shall be adopted by the Member States. 2. Applications for registration or for marketing authorization for medicinal products covered by this Directive lodged after the date set in paragraph 1 shall comply with the provisions of this Directive. 3. Not later than 31 December 1995, the Commission shall present a report to the European Parliament and the Council concerning the application of this Directive. Article 11 This Directive is addressed to the Member States.

31992L0074

1992

Council Directive 92/74/EEC of 22 September 1992 widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products 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 differences currently existing between the provisions laid down by law, regulation or administrative action in the Member States may hinder trade in homeopathic veterinary medicinal products within the Community and lead to discrimination and distortion of competition between manufacturers of these products; Whereas the essential aim of any rules governing the production, distribution and use of veterinary medicinal products must be to safeguard human and animal health; Whereas, despite considerable differences in the status of alternative medicines in the Member States, free choice of treatment should be guaranteed, provided all precautions are taken to ensure the quality of products; Whereas the provisions of Directive 81/851/EEC (4) are not always appropriate for homeopathic veterinary medicinal products; Whereas homeopathic medicine is officially recognized in certain Member States but is only tolerated in other Member States; Whereas, even if homeopathic medicinal products are not always officially recognized, they are nevertheless prescribed and used in most Member States; Whereas it is desirable in the first instance to provide users of these medicinal products with a very clear indication of their homeopathic character and with sufficient guarantees of their quality and safety; Whereas the rules relating to the manufacture, control and inspection of homeopathic veterinary medicinal products must be harmonized to permit the circulation throughout the Community of medicinal products which are safe and of good quality; Whereas, having regard to the particular characteristics of these medicinal products, such as the very low level of active principles they contain and the difficulty of applying to them the conventional statistical methods relating to clinical trials, it is desirable to provide a special, simplified registration procedure for those traditional homeopathic medicinal products which are placed on the market without specific therapeutic indications in a pharmaceutical form and dosage which do not present a risk for the animal; Whereas in the light of current knowledge it appears difficult to allow according to a special, simplified registration procedure the marketing of medicinal products intended to be administered to animals whose flesh or products are intended for human consumption; whereas, however, this question should be re-examined during the preparation of the overall report on the application of this Directive which has to be submitted by the Commission not later than 31 December 1995; Whereas, however, the usual rules governing the authorization to market veterinary medicinal products must be applied to homeopathic veterinary medicinal products marketed with therapeutic indications or in a form which may present risks which must be balanced against the desired therapeutic effect; whereas Member States should be able to apply particular rules for the evaluation of the results of tests and trials intended to establish the safety and efficacy of these medicinal products for pet animals and exotic species, provided that they notify them to the Commission, CHAPTER I Scope Article 1 1. For the purposes of this Directive, 'homeopathic veterinary medicinal product' shall mean any veterinary medicinal product prepared from products, substances or compositions called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in absence thereof, by the pharmacopoeias currently used officially in the Member States. 2. A homeopathic veterinary medicinal product may also contain a number of principles. Article 2 1. The provisions of this Directive shall apply to homeopathic medicinal products for veterinary use. This Directive shall not apply to homeopathic veterinary medicinal products which meet the conditions of Article 4 (4) of Directive 81/851/EEC; however, the withdrawal period referred to in the second subparagraph of that Article 4 (4) shall not apply with regard to homeopathic veterinary medicinal products in which the level of active principles is equal to or less than one part per million. 2. Without prejudice to Article 7 (2), the medicinal products referred to in paragraph 1 shall be identified by the inclusion on their labels, in clearly legible form, of the words 'homeopathic medicinal product for veterinary use'. 3. This Directive shall not apply to immunological homeopathic veterinary medicinal products, which shall be authorized by Member States in accordance with the provisions of Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products (5). CHAPTER II Manufacture, control and inspection Article 3 The provisions of Chapter V of Directive 81/851/EEC shall apply to the manufacture, control, import and export of homeopathic veterinary medicinal products. Article 4 The supervision measures and the sanctions provided for in Chapter VI of Directive 81/851/EEC shall apply to homeopathic veterinary medicinal products. However, the proof of therapeutic effect referred to in Article 37 (1) (b) of the same Directive shall not be required for homeopathic veterinary medicinal products registered in accordance with Article 7 of this Directive or, where appropriate, admitted in accordance with Article 6 (2). Article 5 Member States shall communicate to each other all the information necessary to guarantee the quality and safety of homeopathic veterinary medicinal products manufactured and marketed within the Community, and in particular the information referred to in Articles 39 and 42 of Directive 81/851/EEC. CHAPTER III Placing on the market Article 6 1. Member States shall ensure that homeopathic veterinary medicinal products manufactured and marketed within the Community are registered or authorized in accordance with the provisions of Articles 7, 8 and 9. Each Member State shall take due account of registrations and authorizations previously granted by another Member State. 2. A Member State may refrain from establishing a special, simplified registration procedure for the homeopathic veterinary medicinal products referred to in Article 7. A Member State applying this provision shall inform the Commission accordingly. The Member State concerned shall, by 31 December 1995 at the latest, allow the use in its territory of homeopathic veterinary medicinal products registered by other Member States in accordance with Articles 7 and 8. Article 7 1. Only homeopathic veterinary medicinal products which satisfy all of the following conditions may be subject to a special, simplified registration procedure: - they are intended for administration to pet animals or exotic species whose flesh or products are not intended for human consumption, - they are administered by a route described in the European Pharmacopoeia or, in absence thereof, by the pharmacopoeias currently used officially in the Member States, - no specific therapeutic indication appears on the labelling of the veterinary medicinal product or in any information relating thereto, - there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the medicinal product may not contain either more than one part per 10 000 of the mother tincture or more than 1/100th of the smallest dose used in allopathy with regard to active principles whose presence in an allopathic medicinal product results in the obligation to submit a veterinary prescription. At the time of registration, Member States shall determine the classification for the dispensing of the medicinal product. 2. In addition to the clear mention of the words 'homeopathic veterinary medicinal product without approved therapeutic indications', the labelling and, where appropriate, package insert for the medicinal products referred to in paragraph 1 shall bear the following information and no other information: - the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the pharmacopoeia used in accordance with Article 1 (1), - name and address of the person responsible for marketing and, where appropriate, of the manufacturer, - method of administration and, if necessary, route, - expiry date, in clear terms (month, year), - pharmaceutical form, - contents of the sales presentation, - special storage precautions, if any, - target species, - a special warning if necessary for the medicinal product, - manufacturer's batch number, - registration number. 3. The criteria and rules of procedure provided for in Articles 8 to 15 of Directive 81/851/EEC shall apply by analogy to the special, simplified registration procedure for homeopathic veterinary medicinal products, with the exception of the proof of therapeutic effect. Article 8 A special, simplified application for registration submitted by the person responsible for marketing may cover a series of medicinal products derived from the same homeopathic stock or stocks. The following documents shall be included with the application in order to demonstrate, in particular, the pharmaceutical quality and the batch-to-batch homogeneity of the products concerned: - scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered, - dossier describing how the homeopathic stock or stocks is/are obtained and controlled, and justifying its/their homeopathic nature, on the basis of an adequate homeopathic bibliography; in the case of homeopathic veterinary medicinal products containing biological substances, a description of the measures taken to ensure the absence of pathogens, - manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentiation, - manufacturing authorization for the medicinal products concerned, - copies of any registrations or authorizations obtained for the same medicinal products in other Member States, - one or more specimes or mock-ups of the sales presentation of the medicinal products to be registered, - data concerning the stability of the medicinal product. Article 9 1. Homeopathic veterinary medicinal products other than those referred to in Article 7 shall be authorized in accordance with the provisions of Articles 5 to 15 of Directive 81/851/EEC, including the provisions concerning proof of therapeutic effect, and labelled in accordance with Articles 43 to 50 of the same Directive. 2. A Member State may introduce or retain in its territory specific rules for the pharmacological and toxicological tests and clinical trials of homeopathic veterinary medicinal products intended for pet animals and exotic species whose flesh or products are not intended for human consumption, other than those referred to in Article 7 (1), in accordance with the principles and characteristics of homeopathy as practised in that Member State. In this case, the Member State concerned shall notify the Commission of the specific rules in force. CHAPTER IV Final provisions Article 10 1. Member States shall take the measures necessary to comply with this Directive by 31 December 1993. 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. Applications for registration or for marketing authorization for products covered by this Directive lodged after the date set in paragraph 1 shall comply with the provisions of this Directive. 3. Not later than 31 December 1995, the Commission shall present a report to the Council and to the European Parliament concerning the implementation of this Directive. Article 11 This Directive is addressed to the Member States.

31992L0075

1992

Council Directive 92/75/EEC of 22 September 1992 on the indication by labelling and standard product information of the consumption of energy and other resources by household appliances 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 measures should be taken progressively to achieve the internal market by 31 December 1992; Whereas certain Member States already have their own voluntary schemes for energy labelling and the provision of other energy consumption information for household appliances; whereas one Member State has formally proposed introducing its own compulsory labelling scheme, and other Member States are considering such introduction; whereas the existence of a number of compulsory national schemes would create barriers to intra-Community trade; Whereas Article 130r of the Treaty requires prudent and rational utilization of natural resources; whereas the rational use of energy is one of the principal means by which this objective can be achieved and environmental pollution reduced; Whereas the provision of accurate, relevant and comparable information on the specific energy consumption of household appliances may influence the public's choice in favour of those appliances which consume less energy, thus prompting manufacturers to take steps to reduce the consumption of the appliances which they manufacture; whereas it will also, indirectly, encourage the efficient use of these appliances; whereas, in the absence of this information, the operation of market forces alone will fail to promote the rational use of energy for these appliances; Whereas information plays a key role in the operation of market forces and it is therefore necessary to introduce a uniform label for all appliances of the same type, to provide potential purchasers with supplementary standardized information on those appliances' costs in terms of energy and the consumption of other resources and to take measures to ensure that potential purchasers who do not see the appliance displayed, and thus have no opportunity to see the label, are also supplied with this information; Whereas to this end the energy consumption of and other information concerning each type of appliance must be measured in accordance with harmonized standards and methods and the application of these standards and methods must be monitored at the marketing stage; Whereas Directive 79/530/EEC (4) sought to promote these aims in the case of household appliances; whereas, however, only one implementing Directive for electric ovens has been adopted and few Member States have introduced this label; whereas it is therefore now necessary to learn from the experience acquired and to strengthen the provisions of that Directive; whereas Directive 79/530/EEC must therefore be replaced and Directive 79/531/EEC (5) applying to those electric ovens should be revised and subsequently integrated into the present scheme; Whereas a completely voluntary scheme would lead to only some appliances being labelled, or supplied with standard product information, with the risk that this might result in confusion for some consumers; whereas the present scheme must therefore ensure that for all the appliances concerned, the energy consumption is indicated by labelling and standard product fiches are provided; Whereas household appliances use a wide variety of forms of energy, with electricity and gas being the most important; whereas this Directive must therefore in principle cover appliances using any form of energy; Whereas Council Directive 86/594/EEC of 1 December 1986 on airborne noise emitted by household appliances (6) provides for an indication of noise emission to be included on energy labels, where appropriate; whereas provision must therefore be made for the incorporation of any other information and labelling covered by Community schemes; Whereas only those types of appliances whose aggregate energy use is significant and which afford adequate scope for increased efficiency need be included, Article 1 1. The purpose of this Directive is to enable the harmonization of national measures on the publication, particularly by means of labelling and of product information, of information on the consumption of energy and of other essential resources, and additional information concerning certain types of household appliances, thereby allowing consumers to choose more energy-efficient appliances. This Directive shall apply to the following types of household appliances, even where these are sold for non-household uses: - refrigerators, freezers and their combinations, - washing machines, driers and their combinations, - dishwashers, - ovens, - water heaters and hot-water storage appliances, - lighting sources, - air-conditioning appliances. 2. Further types of household appliances may be added to the list in this Article in accordance with Article 9 (b). 3. This Directive shall not apply to the rating plate or its equivalent affixed for safety purposes to such appliances. 4. For the purpose of this Directive: - dealer means a retailer or other person who sells, hires, offers for hire-purchase or displays household appliances to end-users, - supplier means the manufacturer or his authorized representative in the Community or the person who places the product on the Community market, - information sheet means a standard table of information relating to the appliance in question, - other essential resources means water, chemicals or any other substance consumed by an appliance in normal use, - supplementary information means other information concerning the performance of an appliance, which relates to, or is helpful in evaluating, its use of energy or other essential resources. 5. There shall be no obligation to label or to provide fiches in respect of models of appliances of which production has ceased before the relevant implementing directive comes into effect, or second-hand appliances. Article 2 1. Information relating to the consumption of electric energy, other forms of energy and other essential resources and supplementary information shall be brought to consumers' attention by means of a fiche and a label related to household appliances offered for sale, hire, hire-purchase or displayed to end-users. 2. Details relating to the label and the fiche shall be defined by directives relating to each type of appliance adopted pursuant to this Directive in accordance with Article 9. 3. Technical documentation shall be established which shall be sufficient to enable the accuracy of the information contained in the label and the fiche to be assessed. It shall include: - a general description of the product, - the results of design calculations carried out, where these are relevant, - test reports, where available, including those carried out by relevant notified organizations as defined under other Community legislation, - where values are derived from those obtained for similar models, the same information for these models. 4. The supplier shall establish the technical documentation described in paragraph 3. To this end it may use documentation already required on the basis of relevant Community legislation. The supplier shall make this documentation available for inspection purposes for a period ending five years after the last product has been manufactured. Article 3 1. All suppliers placing on the market the household appliances specified in the implementing directives shall supply a label in accordance with this Directive. The labels used shall in all respects comply with this Directive and with the implementing directives. 2. In addition to the labels, suppliers shall provide a product fiche. This fiche shall be contained in all product brochures. Where these are not provided by the supplier, he shall supply fiches with other literature provided with the appliance. The fiches used shall in all respects comply with this Directive and with the implementing Directives. 3. Suppliers shall be responsible for the accuracy of the labels and fiches that they supply. 4. The supplier shall be deemed to have given his consent to the publication of the information given on the label or the fiche. Article 4 In respect of labelling and product information, the following provisions shall apply: (a) whenever an appliance specified in an implementing directive is displayed, dealers shall attach an appropriate label, in the clearly visible position specified in the relevant implementing directive, and in the relevant language version; (b) the supplier shall supply the necessary labels free of charge, to dealers referred to in paragraph (a). Suppliers are free to choose their own system for delivery of labels. However, where a dealer sends a request for labels, the supplier must ensure that the requested labels are delivered promptly. Article 5 Where the relevant appliances are offered for sale, hire or hire-purchase by mail order, by catalogue, or by other means which imply that the potential customer cannot be expected to see the appliance displayed, the implementing directives shall make provision to ensure that potential customers are provided with the essential information specified in the label or the fiche before buying an appliance. Article 6 The implementing Directives shall make provision for the inclusion on the label or on the fiche of information on airborne noise, where such information is provided pursuant to Directive 86/594/EEC and of other public information relating to the relevant appliance, which is provided pursuant to other Community legislation. Article 7 Member States shall take all necessary measures to ensure that: (a) all suppliers and dealers established in their territory fulfil their obligations under this Directive; (b) if this is likely to mislead or confuse, the display of other labels, marks, symbols or inscriptions relating to energy consumption which do not comply with the requirements of this Directive and of the relevant implementing directives is prohibited. This prohibition shall not apply to Community or national environmental labelling schemes; (c) the introduction of the system of labels and fiches concerning energy consumption is accompanied by educational and promotional information campaigns aimed at encouraging more responsible use of energy by private consumers. Article 8 1. Where the provisions of this Directive and of the implementing directives are satisfied, Member States shall neither prohibit nor restrict the placing on the market of the household appliances covered by an implementing directive. 2. Unless they have evidence to the contrary, Member States shall deem labels and fiches to comply with the provisions of this Directive and the implementing directives. They may require suppliers to furnish evidence within the meaning of Article 2 (3) concerning the accuracy of the information supplied on their labels or fiches when they have reason to suspect it is incorrect. Article 9 The measures relating to the establishment and operation of the scheme shall be adopted and adapted to technical progress in accordance with the procedure set out in Article 10. These measures are: (a) the implementing directives; (b) the addition of further household appliances to the list in Article 1 (1) where significant energy savings are likely to be achieved. Article 10 The Commission shall be assisted by a committee composed of representatives of the Member States and chaired by the representative of the Commission. The representative of the Commission 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. The opinion shall be delivered by the majority laid down in Article 148 (2) of the EEC Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. If 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 relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures, by a simple majority. Article 11 After the expiry of a period of three years from the application of this Directive, the Commission shall make an assessment of the implementation thereof and the results obtained. The assessment shall be the subject of a report to be submitted to the European Parliament and the Council. Article 12 The implementing directives shall specify: (a) the exact definition of the type of appliances to be included; (b) the measurement standards and methods to be used in obtaining the information referred to in Article 1 (1); (c) details of the technical documentation required under Article 2 (3); (d) the design and content of the label referred to in Article 2, which as far as possible shall have uniform design characteristics; (e) the location where the label shall be fixed to the appliance. Where appropriate they may provide for the label to be attached to or printed on the packaging; (f) the content and where appropriate the format and other details concerning the fiche or further information specified in Article 3 (2). The information on the label shall also be included on the fiche; (g) the information to be provided in the case of offers for sale covered by Article 5, and the manner in which it is to be provided. Article 13 Directive 79/530/EEC is hereby repealed, with effect from 1 January 1994. Directive 79/531/EEC shall be considered as implementing this Directive for electric ovens; however Member States may refrain from its compulsory introduction, until a date set in a revised implementing directive concerning ovens passed in accordance with the procedure laid down in Article 10. Article 14 1. Member States shall adopt the provisions necessary to comply with this Directive by 1 July 1993. They shall immediately notify the Commission of these measures. They shall bring these provisions into force by not later than 1 January 1994. 2. 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. 3. Member States shall communicate to the Commission the main provisions of domestic law which they adopt in the field covered by this Directive. Article 15 This Directive is addressed to the Member States.

31992L0076

1992

Commission Directive 92/76/EEC of 6 October 1992 recognizing protected zones exposed to particular plant health risks in the Community Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), as last amended by Commission Directive 92/10/EEC (2), and in particular the first subparagraph of Article 2 (1) (h) thereof, Having regard to the requests made by Denmark, Greece, Spain, France, Ireland, Italy, Portugal and the United Kingdom, Whereas under the provisions of Directive 77/93/EEC, 'protected zones' exposed to particular plant health risks may be defined and therefore may be accorded special protection under conditions compatible with the internal market; Whereas, moreover, Member States may request the recognition as protected zone, in particular, of a zone in which one or more harmful organisms referred to in the said Directive, which are established in one or more parts of the Community, are not endemic or established, despite conditions being favourable for them to establish themselves there; Whereas certain Member States have requested that certain zones be recognized as protected zones; Whereas the abovementioned requests should be based on the grounds that the results of appropriate surveys, monitored by Commission experts, confirm that one or more of the harmful organisms, in respect of which the zone is to be recognized as a protected zone, are not endemic or established there; Whereas, however, the details of such surveys are not yet fully established at Community level; Whereas the recognition should be provisional only and based on the available information submitted by the Member States concerned; Whereas an extension of the recognition beyond 1994 will be decided only on the basis of the results of the required surveys as monitored by Commission experts; Whereas a provision should be foreseen for modifying later, if necessary, the list of protected zones; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant health, Article 1 The zones in the Community listed in the Annex are hereby recognized for a period expiring on 31 December 1994 as 'protected zones' referred to in the first subparagraph of Article 2 (1) (h) of Directive 77/93/EEC, in respect of the harmful organism(s) listed against their names in the Annex. Article 2 The extension of the recognition beyond the date referred to in Article 1, and any amendment to the list of protected zones referred to in Article 1, shall be made in accordance with the procedure laid down in Article 16a of Directive 77/93/EEC, taking into account the results of appropriate surveys based on Community conditions and monitored by Commission experts. Article 3 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive on the date referred to in Article 3 (1) of Council Directive 91/683/EEC (3). They shall forthwith inform the Commission thereof. When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall immediately communicate to the Commission all provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 4 This Directive is addressed to the Member States.

31992L0079

1992

Council Directive 92/79/EEC of 19 October 1992 on the approximation of taxes on cigarettes Having regard to the Treaty establishing the European Economic Community, and in particular Article 99 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 Directive 72/464/EEC (4) lays down general provisions concerning excise duties on manufactured tobacco and special provisions concerning the structure of excise duties applicable to cigarettes; Whereas Directive 79/32/EEC (5) laid down the definitions of the various groups of manufactured tobacco; Whereas for the completion on 1 January 1993 of an internal market without frontiers it is necessary to establish an overall minimum excise duty for cigarettes; Whereas it is necessary for the Kingdom of Spain to have a transitional period of two years in order to attain that overall minimum excise duty; Whereas the Portuguese Republic should be granted the possibility of a reduced rate for cigarettes made by small-scale producers and consumed in the most remote regions of the Azores and Madeira; Whereas a procedure should be introduced so that, as regards the overall incidence and the structure of excise duties on cigarettes, it will be possible every two years to make the adjustments necessary to take account of the proper functioning of the internal market and the wider objectives of the Treaty, Article 1 1. Not later than 1 January 1993, Member States shall apply to cigarettes minimum consumption taxes in accordance with the rules provided for in this Directive. 2. Paragraph 1 shall apply to the taxes which, pursuant to Directive 72/464/EEC, are levied on cigarettes and which comprise: (a) a specific excise duty per unit of the product; (b) a proportional excise duty calculated on the basis of the maximum retail selling price; (c) a VAT proportional to the retail selling price. Article 2 Not later than 1 January 1993, each Member State shall apply an overall minimum excise duty (specific duty plus ad valorem duty excluding VAT) the incidence of which shall be set at 57 % of the retail selling price (inclusive of all taxes) for cigarettes of the price category most in demand. The overall minimum excise duty on cigarettes shall be determined on the basis of cigarettes of the price category most in demand according to data established as at 1 January of each year, beginning on 1 January 1993. Article 3 1. The Kingdom of Spain shall have a transitional period of two years, starting on 1 January 1993, to attain the overall minimum excise duty laid down in Article 2. 2. The Portuguese Republic may apply a reduced rate of up to 50 % less than that laid down in Article 2 to cigarettes consumed in the most remote regions of the Azores and Madeira, made by small-scale manufacturers each of whose annual production does not exceed 500 tonnes. Article 4 Every two years, and for the first time not later than 31 December 1994, the Council, acting on the basis of a report and, where appropriate, a proposal from the Commission, shall examine the overall minimum excise duty laid down in Article 2, the provisions of Article 3 (2) and the structure of excise duties as defined in Article 10b of Directive 72/464/EEC and, acting unanimously after consulting the European Parliament, shall adopt the necessary measures. The report by the Commission and the examination by the Council shall take into account the proper functioning of the internal market and the wider objectives of the Treaty. Article 5 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1992. 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 reference shall be laid down by the Member States. 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 6 This Directive is addressed to the Member States.

31992L0077

1992

Council Directive 92/77/EEC of 19 October 1992 supplementing the common system of value added tax and amending Directive 77/388/EEC (approximation of VAT rates) Having regard to the Treaty establishing the European Economic Community, and in particular Article 99 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 completing the internal market, which is one of the fundamental objectives of the Community, requires as a first step that fiscal controls at the frontiers be abolished; Whereas, if distortions are to be avoided, such abolition implies in the case of value added tax, not only a uniform tax base but also a number of rates and rate levels which are sufficiently close as between Member States; whereas it is therefore necessary to amend Directive 77/388/EEC (4); Whereas, during the transitional period, certain derogations concerning number and level of rates should be possible, Article 1 Directive 77/388/EEC is hereby amended as follows: 1. Article 12 (3) is replaced by the following: '3. (a) From 1 January 1993 Member States shall apply a standard rate which, until 31 December 1996, may not be less than 15 %. On the basis of the report on the operation of the transitional arrangements and proposals on the definitive arrangements to be submitted by the Commission pursuant to Article 281 the Council shall decide unanimously before 31 December 1995 on the level of the minimum rate to be applied after 31 December 1996 with regard to the standard rate. Member States may also apply either one or two reduced rates. The reduced rates may not be less than 5 % and shall only apply to supplies of the categories of goods and services specified in Annex H. (b) Member States may apply a reduced rate to supplies of natural gas and electricity provided that no risk of distortion of competition exists. A Member State intending to apply such a rate must, before doing so, inform the Commission. The Commission shall give a decision on the existence of a risk of distortion of competition. If the Commission has not taken that decision within three months of the receipt of the information a risk of distortion of competition is deemed not to exist. (c) The rules concerning the rates applied to works of art, antiques and collector's items, shall be determined by the directive relating to the special arrangements applicable to second-hand goods, works of art, antiques and collector's items. The Council shall adopt this Directive before 31 December 1992. (d) The rules concerning the taxation of agricultural outputs other than those falling within category 1 of Annex H shall be decided unanimously by the Council before 31 December 1994 on the basis of a Commission proposal. Until 31 December 1994, those Member States currently applying a reduced rate may continue to do so; those currently applying a standard rate may not apply a reduced rate. This will allow a two-year postponement of the application of the standard rate. (e) The rules concerning the regime and the rates applied to gold shall be determined by a directive relating to special arrangements applicable to gold. The Commission shall make such a proposal in time for its adoption by the Council, acting unanimously, before 31 December 1992. Member States will take all necessary measures to combat fraud in this area from 1 January 1993. These measures may include the introduction of a system of accounting for VAT on supplies of gold between taxable persons in the same Member State which provides for the payment of tax by the buyer on behalf of the seller and a simultaneous right for the buyer to a deduction of the same amount of tax as input tax.'; 2. the first sentence of Article 12 (4) shall be deleted; 3. the following subparagraph is added to Article 12 (4): 'On the basis of a report from the Commission, the Council shall, starting in 1994, review the scope of the reduced rates every two years. The Council, acting unanimously on a proposal from the Commission, may decide to alter the list of goods and services in Annex H.'; 4. Article 28 (2) is replaced by the following: '2. Notwithstanding Article 12 (3), the following provisions shall apply during the transitional period referred to in Article 281. (a) Exemptions with refund of the tax paid at the preceding stage and reduced rates lower than the minimum rate laid down in Article 12 (3) in respect of the reduced rates, which were in force on 1 January 1991 and which are in accordance with Community law, and satisfy the conditions stated in the last indent of Article 17 of the second Council Directive of 11 April 1967, may be maintained. Member States shall adopt the measures necessary to ensure the determination of own resources relating to these operations. In the event that the provisions of this paragraph create for Ireland distortions of competition in the supply of energy products for heating and lighting, Ireland may, on specific request, be authorized by the Commission to apply a reduced rate to such supplies, in accordance with Article 12 (3). In that case, Ireland shall submit its request to the Commission together with all necessary information. If the Commission has not taken a decision within three months of receiving the request, Ireland shall be deemed to be authorized to apply the proposed reduced rates. (b) Member States which, at 1 January 1991 in accordance with Community law, applied exemptions with refund of tax paid at the preceding stage, or reduced rates lower than the minimum laid down in Article 12 (3) in respect of the reduced rates, to goods and services other than those specified in Annex H, may apply the reduced rate or one of the two reduced rates provided for in Article 12 (3) to any such supplies. (c) Member States which under the terms of Article 12 (3) will be obliged to increase their standard rate as applied at 1 January 1991 by more than 2 %, may apply a reduced rate lower than the minimum laid down in Article 12 (3) in respect of the reduced rate to supplies of categories of goods and services specified in Annex H. Furthermore, those Member States may apply such a rate to restaurant services, children's clothing, children's footwear and housing. Member States may not introduce exemptions with refund of the tax at the preceding stage on the bais of this paragraph. (d) Member States which at 1 January 1991 applied a reduced rate to restaurant services, children's clothing, children's footwear and housing, may continue to apply such a rate to such supplies. (e) Member States which at 1 January 1991 applied a reduced rate to supplies of goods and services other than those specified in Annex H may apply the reduced rate or one of the two reduced rates provided for in Article 12 (3) to such supplies, provided that the rate is not lower than 12 %. (f) The Hellenic Republic may apply VAT rates up to 30 % lower than the corresponding rates applied in mainland Greece in the departments of Lesbos, Chios, Samos, the Dodecanese and the Cyclades, and on the following islands in the Aegean: Thasos, Northern Sporades, Samothrace and Skiros. (g) On the basis of a report from the Commission, the Council shall, before 31 December 1994, reexamine the provisions of subparagraphs (a) to (f) above in relation to the proper functioning of the internal market in particular. In the event of significant distortions of competition arising, the Council, acting unanimously on a proposal from the Commission, shall adopt appropriate measures.'; 5. Annex H in the Annex to this Directive shall be appended. Article 2 1. Member States shall bring into force the laws, regulations and adminstrative provisions necessary to comply with this Directive not later than 31 December 1992. 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 reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. Article 3 This Directive is addressed to the Member States.

31992L0085

1992

Council Directive 92/85/EEC of 19 October 1992 on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding (tenth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) Having regard to the Treaty establishing the European Economic Community, and in particular Article 118a thereof, Having regard to the proposal from the Commission, drawn up after consultation with the Advisory Committee on Safety, Hygiene and Health Protection at work (1), In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Article 118a of the Treaty provides that the Council shall adopt, by means of directives, minimum requirements for encouraging improvements, especially in the working environment, to protect the safety and health of workers; Whereas this Directive does not justify any reduction in levels of protection already achieved in individual Member States, the Member States being committed, under the Treaty, to encouraging improvements in conditions in this area and to harmonizing conditions while maintaining the improvements made; Whereas, under the terms of Article 118a of the Treaty, the said directives are to avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings; Whereas, pursuant to Decision 74/325/EEC (4), as last amended by the 1985 Act of Accession, the Advisory Committee on Safety, Hygiene and Health protection at Work is consulted by the Commission on the drafting of proposals in this field; Whereas the Community Charter of the fundamental social rights of workers, adopted at the Strasbourg European Council on 9 December 1989 by the Heads of State or Government of 11 Member States, lays down, in paragraph 19 in particular, that: 'Every worker must enjoy satisfactory health and safety conditions in his working environment. Appropriate measures must be taken in order to achieve further harmonization of conditions in this area while maintaining the improvements made`; Whereas the Commission, in its action programme for the implementation of the Community Charter of the fundamental social rights of workers, has included among its aims the adoption by the Council of a Directive on the protection of pregnant women at work; Whereas Article 15 of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (5) provides that particularly sensitive risk groups must be protected against the dangers which specifically affect them; Whereas pregnant workers, workers who have recently given birth or who are breastfeeding must be considered a specific risk group in many respects, and measures must be taken with regard to their safety and health; Whereas the protection of the safety and health of pregnant workers, workers who have recently given birth or workers who are breastfeeding should not treat women on the labour market unfavourably nor work to the detriment of directives concerning equal treatment for men and women; Whereas some types of activities may pose a specific risk, for pregnant workers, workers who have recently given birth or workers who are breastfeeding, of exposure to dangerous agents, processes or working conditions; whereas such risks must therefore be assessed and the result of such assessment communicated to female workers and/or their representatives; Whereas, further, should the result of this assessment reveal the existence of a risk to the safety or health of the female worker, provision must be made for such worker to be protected; Whereas pregnant workers and workers who are breastfeeding must not engage in activities which have been assessed as revealing a risk of exposure, jeopardizing safety and health, to certain particularly dangerous agents or working conditions; Whereas provision should be made for pregnant workers, workers who have recently given birth or workers who are breastfeeding not to be required to work at night where such provision is necessary from the point of view of their safety and health; Whereas the vulnerability of pregnant workers, workers who have recently given birth or who are breastfeeding makes it necessary for them to be granted the right to maternity leave of at least 14 continuous weeks, allocated before and/or after confinement, and renders necessary the compulsory nature of maternity leave of at least two weeks, allocated before and/or after confinement; Whereas the risk of dismissal for reasons associated with their condition may have harmful effects on the physical and mental state of pregnant workers, workers who have recently given birth or who are breastfeeding; whereas provision should be made for such dismissal ot be prohibited; Whereas measures for the organization of work concerning the protection of the health of pregnant workers, workers who have recently given birth or workers who are breastfeeding would serve no purpose unless accompanied by the maintenance of rights linked to the employment contract, including maintenance of payment and/or entitlement to an adequate allowance; Whereas, moreover, provision concerning maternity leave would also serve no purpose unless accompanied by the maintenance of rights linked to the employment contract and or entitlement to an adequate allowance; Whereas the concept of an adequate allowance in the case of maternity leave must be regarded as a technical point of reference with a view to fixing the minimum level of protection and should in no circumstances be interpreted as suggesting an analogy between pregnancy and illness, SECTION I PURPOSE AND DEFINITIONS Article 1 Purpose 1. The purpose of this Directive, which is the tenth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC, is to implement measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or who are breastfeeding. 2. The provisions of Directive 89/391/EEC, except for Article 2 (2) thereof, shall apply in full to the whole area covered by paragraph 1, without prejudice to any more stringent and/or specific provisions contained in this Directive. 3. This Directive may not have the effect of reducing the level of protection afforded to pregnant workers, workers who have recently given birth or who are breastfeeding as compared with the situation which exists in each Member State on the date on which this Directive is adopted. Article 2 Definitions For the purposes of this Directive: (a) pregnant worker shall mean a pregnant worker who informs her employer of her condition, in accordance with national legislation and/or national practice; (b) worker who has recently given birth shall mean a worker who has recently given birth within the meaning of national legislation and/or national practice and who informs her employer of her condition, in accordance with that legislation and/or practice; (c) worker who is breastfeeding shall mean a worker who is breastfeeding within the meaning of national legislation and/or national practice and who informs her employer of her condition, in accordance with that legislation and/or practice. SECTION II GENERAL PROVISIONS Article 3 Guidelines 1. In consultation with the Member States and assisted by the Advisory Committee on Safety, Hygiene and Health Protection at Work, the Commission shall draw up guidelines on the assessment of the chemical, physical and biological agents and industrial processes considered hazardous for the safety or health of workers within the meaning of Article 2. The guidelines referred to in the first subparagraph shall also cover movements and postures, mental and physical fatigue and other types of physical and mental stress connected with the work done by workers within the meaning of Article 2. 2. The purpose of the guidelines referred to in paragraph 1 is to serve as a basis for the assessment referred to in Article 4 (1). To this end, Member States shall bring these guidelines to the attention of all employers and all female workers and/or their representatives in the respective Member State. Article 4 Assessment and information 1. For all activities liable to involve a specific risk of exposure to the agents, processes or working conditions of which a non-exhaustive list is given in Annex I, the employer shall assess the nature, degree and duration of exposure, in the undertaking and/or establishment concerned, of workers within the meaning of Article 2, either directly or by way of the protective and preventive services referred to in Article 7 of Directive 89/391/EEC, in order to: - assess any risks to the safety or health and any possible effect on the pregnancys or breastfeeding of workers within the meaning of Article 2, - decide what measures should be taken. 2. Without prejudice to Article 10 of Directive 89/391/EEC, workers within the meaning of Article 2 and workers likely to be in one of the situations referred to in Article 2 in the undertaking and/or establishment concerned and/or their representatives shall be informed of the results of the assessment referred to in paragraph 1 and of all measures to be taken concerning health and safety at work. Article 5 Action further to the results of the assessment 1. Without prejudice to Article 6 of Directive 89/391/EEC, if the results of the assessment referred to in Article 4 (1) reveal a risk to the safety or health or an effect on the pregnancy or breastfeeding of a worker within the meaning of Article 2, the employer shall take the necessary measures to ensure that, by temporarily adjusting the working conditions and/or the working hours of the worker concerned, the exposure of that worker to such risks is avoided. 2. If the adjustment of her working conditions and/or working hours is not technically and/or objectively feasible, or cannot reasonably be required on duly substantiated grounds, the employer shall take the necessary measures to move the worker concerned to another job. 3. If moving her to another job is not technically and/or objectively feasible or cannot reasonably be required on duly substantiated grounds, the worker concerned shall be granted leave in accordance with national legislation and/or national practice for the whole of the period necessary to protect her safety or health. 4. The provisions of this Article shall apply mutatis mutandis to the case where a worker pursuing an activity which is forbidden pursuant to Article 6 becomes pregnant or starts breastfeeding and informs her employer thereof. Article 6 Cases in which exposure is prohibited In addition to the general provisions concerning the protection of workers, in particular those relating to the limit values for occupational exposure: 1. pregnant workers within the meaning of Article 2 (a) may under no circumstances be obliged to perform duties for which the assessment has revealed a risk of exposure, which would jeopardize safety or health, to the agents and working conditions listed in Annex II, Section A; 2. workers who are breastfeeding, within the meaning of Article 2 (c), may under no circumstances be obliged to perform duties for which the assessment has revealed a risk of exposure, which would jeopardize safety or health, to the agents and working conditions listed in Annex II, Section B. Article 7 Night work 1. Member States shall take the necessary measures to ensure that workers referred to in Article 2 are not obliged to perform night work during their pregnancy and for a period following childbirth which shall be determined by the national authority competent for safety and health, subject to submission, in accordance with the procedures laid down by the Member States, of a medical certificate stating that this is necessary for the safety or health of the worker concerned. 2. The measures referred to in paragraph 1 must entail the possibility, in accordance with national legislation and/or national practice, of: (a) transfer to daytime work; or (b) leave from work or extension of maternity leave where such a transfer is not technically and/or objectively feasible or cannot reasonably by required on duly substantiated grounds. Article 8 Maternity leave 1. Member States shall take the necessary measures to ensure that workers within the meaning of Article 2 are entitled to a continuous period of maternity leave of a least 14 weeks allocated before and/or after confinement in accordance with national legislation and/or practice. 2. The maternity leave stipulated in paragraph 1 must include compulsory maternity leave of at least two weeks allocated before and/or after confinement in accordance with national legislation and/or practice. Article 9 Time off for ante-natal examinations Member States shall take the necessary measures to ensure that pregnant workers within the meaning of Article 2 (a) are entitled to, in accordance with national legislation and/or practice, time off, without loss of pay, in order to attend ante-natal examinations, if such examinations have to take place during working hours. Article 10 Prohibition of dismissal In order to guarantee workers, within the meaning of Article 2, the exercise of their health and safety protection rights as recognized under this Article, it shall be provided that: 1. Member States shall take the necessary measures to prohibit the dismissal of workers, within the meaning of Article 2, during the period from the beginning of their pregnancy to the end of the maternity leave referred to in Article 8 (1), save in exceptional cases not connected with their condition which are permitted under national legislation and/or practice and, where applicable, provided that the competent authority has given its consent; 2. if a worker, within the meaning of Article 2, is dismissed during the period referred to in point 1, the employer must cite duly substantiated grounds for her dismissal in writing; 3. Member States shall take the necessary measures to protect workers, within the meaning of Article 2, from consequences of dismissal which is unlawful by virtue of point 1. Article 11 Employment rights In order to guarantee workers within the meaning of Article 2 the exercise of their health and safety protection rights as recognized in this Article, it shall be provided that: 1. in the cases referred to in Articles 5, 6 and 7, the employment rights relating to the employment contract, including the maintenance of a payment to, and/or entitlement to an adequate allowance for, workers within the meaning of Article 2, must be ensured in accordance with national legislation and/or national practice; 2. in the case referred to in Article 8, the following must be ensured: (a) the rights connected with the employment contract of workers within the meaning of Article 2, other than those referred to in point (b) below; (b) maintenance of a payment to, and/or entitlement to an adequate allowance for, workers within the meaning of Article 2; 3. the allowance referred to in point 2 (b) shall be deemed adequate if it guarantees income at least equivalent to that which the worker concerned would receive in the event of a break in her activities on grounds connected with her state of health, subject to any ceiling laid down under national legislation; 4. Member States may make entitlement to pay or the allowance referred to in points 1 and 2 (b) conditional upon the worker concerned fulfilling the conditions of eligibilty for such benefits laid down under national legislation. These conditions may under no circumstances provide for periods of previous employment in excess of 12 months immediately prior to the presumed date of confinement. Article 12 Defence of rights Member States shall introduce into their national legal systems such measures as are necessary to enable all workers who should themselves wronged by failure to comply with the obligations arising from this Directive to pursue their claims by judicial process (and/or, in accordance with national laws and/or practices) by recourse to other competent authorities. Article 13 Amendments to the Annexes 1. Strictly technical adjustments to Annex I as a result of technical progress, changes in international regulations or specifications and new findings in the area covered by this Directive shall be adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC. 2. Annex II may be amended only in accordance with the procedure laid down in Article 118a of the Treaty. Article 14 Final provisions 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than two years after the adoption thereof or ensure, at the latest two years after adoption of this Directive, that the two sides of industry introduce the requisite privisions by means of collective agreements, with Member States being required to make all the necessary provisions to enable them at all times to guarantee the results laid down by this Directive. They shall forthwith inform the Commission thereof. 2. When Member States adopt the measures referred to in paragraph 1, they shall contain a reference of 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. 3. Member States shall communicate to the Commission the texts of the essential provisions of national law which they have already adopted or adopt in the field governed by this Directive. 4. Member States shall report to the Commission every five years on the practical implementation of the provisions of this Directive, indicating the points of view of the two sides of industry. However, Member States shall report for the first time to the Commission on the practical implementation of the provisions of this Directive, indicating the points of view of the two sides of industry, four years after its adoption. The Commission shall inform the European Parliament, the Council, the Economic and Social Committee and the Advisory Committee on Safety, Hygiene and Health Protection at Work. 5. The Commission shall periodically submit to the European Parliament, the Council and the Economic and Social Committee a report on the implementation of this Directive, taking into account paragraphs 1, 2 and 3. 6. The Council will re-examine this Directive, on the basis of an assessment carried out on the basis of the reports referred to in the second subparagraph of paragraph 4 and, should the need arise, of a proposal, to be submitted by the Commission at the latest five years after adoption of the Directive. Article 15 This Directive is addressed to the Member States.

31992L0078

1992

Council Directive 92/78/EEC of 19 October 1992 amending Directives 72/464/EEC and 79/32/EEC on taxes other than turnover taxes which are levied on the consumption of manufactured tobacco Having regard to the Treaty establishing the European Economic Community, and in particular Article 99 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 Directive 72/464/EEC (4) lays down general provisions concerning excise duties on manufactured tobacco and special provisions concerning the structure of excise duties applicable to cigarettes; Whereas Directive 79/32/EEC (5) laid down the definitions of the various groups of manufactured tobacco; Whereas the definition of manufactured tobacco should no longer extend to snuff and chewing tobacco; Whereas in Article 3 (1) of Directive 72/464/EEC and in Article 1 (1) of Directive 79/32/EEC a distinction needs to be made between fine-cut tobacco for the rolling of cigarettes and other smoking tobacco; Whereas in Article 4 (1) and 6 (2) of Directive 72/464/EEC the concept of import and release for consumption needs to be modified in connection with the abolition of fiscal frontiers; Whereas in Article 5 (1) of Directive 72/464/EEC a manufacturer needs to be defined as a natural or legal person who actually prepares tobacco products and sets the maximum retail selling price for each of the Member States for which the products in question are to be released for consumption; Whereas a majority of Member States grant exemptions from excise duty or make refunds of excise duty in respect of certain types of manufactured tobacco depending on the use which is made of them, and whereas the exemptions or refunds for particular uses need to be specified in this Directive; Whereas the definitions of tobacco products are all-embracing and therefore the reference to subheading 24.02 E of the Common Customs Tariff should be deleted from Article 2 (3) and (4) of Directive 79/32/EEC; Whereas rolls of tobacco capable of being smoked as they are after simple handling should also be deemed to be cigarettes for the purposes of uniform taxation of these products; Whereas Germany should be authorized to tax rolls at least at the rate or amount applicable to fine-cut tobacco for the rolling of cigarettes until 31 December 1998 at the latest; Whereas Articles 5, 6, 7 (3) and 8 of Directive 79/32/EEC have lapsed and should be deleted, Article 1 Directive 72/464/EEC is hereby amended as follows: 1. Article 2 shall be deleted; 2. Article 3 shall be amended as follows: (a) point (c) of paragraph 1 shall be replaced by the following: '(c) smoking tobacco: - fine-cut tobacco for the rolling of cigarettes, - other smoking tobacco'; (b) points (d) and (e) shall be deleted; 3. Article 4 (1) shall be amended as follows: the phrase 'national and imported cigarettes' shall be replaced by 'cigarettes manufactured in the Community and those imported from non-member countries'; 4. Article 5 (1) shall be replaced by the following: '1. Manufacturers established in the Community, or, where appropriate, their representatives or authorized agents in the Community and importers of tobacco from non-member countries shall be free to determine the maximum retail selling price for each of their products for each Member State for which the products in question are to be released for consumption. This provision may not, however, hinder implementation of the national systems of legislation regarding the control of price levels or the observance of imposed prices, provided that they are compatible with Community legislation. A natural or legal person who converts tobacco into manufactured products prepared for retail sale shall be deemed to be a manufacturer.'; 5. In Article 6 (2), the word 'national' shall be deleted; 6. the following Article shall be inserted: 'Article 6a The following may be exempted from excise duty or excise duty already paid on them may be refunded: (a) denatured manufactured tobacco used for industrial or horticultural purposes; (b) manufactured tobacco which is destroyed under administrative supervision; (c) manufactured tobacco which is solely intended for scientific tests and for tests connected with product quality; (d) manufactured tobacco which is re-worked by the producer. Member States shall determine the conditions and formalities to which the abovementioned exemptions or refunds are subject.'; 7. Article 10b (5) shall be replaced by the following: '5. Member States may levy a minimum excise duty on cigarettes and on fine-cut tobacco for the rolling of cigarettes, provided that this does not have the effect of raising the total tax to more than 90 % of the total tax on the most popular price category of cigarettes or the most popular price category of fine-cut tobacco for the rolling of cigarettes respectively.'; 8. Article 12 (1) shall be amended as follows: 'Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1973. They shall immediately inform the Commission thereof.' Article 2 Council Directive 79/32/EEC is hereby amended as follows: 1. Article 1 shall be amended as follows: (a) point (c) of paragraph 1 shall be replaced by the following: '(c) smoking tobacco: - fine-cut tobacco for the rolling of cigarettes, - other smoking tobacco'; (b) points (d) and (e) shall be deleted; 2. Article 2 shall be amended as follows: (a) in point 3, the words 'falling within subheading 24.02 E of the Common Customs Tariff' shall be deleted; (b) in point 4, the words 'falling within subheading 24.02 E of the Common Customs Tariff' shall be deleted; 3. Article 3 (1) shall be replaced by the following: '1. The following shall be deemed to be cigarettes: (a) rolls of tobacco capable of being smoked as they are and which are not cigars or cigarillos within the meaning of Article 2; (b) rolls of tobacco which, by simple non-industrial handling, are inserted into cigarette-paper tubes; (c) rolls of tobacco which, by simple non-industrial handling, are wrapped in cigarette paper. Until 31 December 1998, the Federal Republic of Germany shall be authorized to tax the rolls of tobacco referred to in (b) at least at the rate or amount applicable to fine-cut tobacco for the rolling of cigarettes.'; 4. The following Article shall be inserted: 'Article 4a Smoking tobacco as defined in Article 4 in which more than 25 % by weight of the tobacco particles have a cut width of less than 1 millimetre shall be deemed to be fine-cut tobacco for the rolling of cigarettes. Member States which do not apply this cut width of 1 millimetre on 1 January 1993 shall have until 31 December 1997 to comply with this provision. Member States may also deem smoking tobacco in which more than 25 % by weight of the tobacco particles have a cut width of more than 1 millimetre and which was sold or intended to be sold for the rolling of cigarettes to be fine-cut tobacco for the rolling of cigarettes.'; 5. Articles 5, 6, 7 (3) and 8 shall be deleted; 6. Article 9 shall be amended as follows: (a) in paragraph 1, the figure '1' shall be deleted; (b) paragraphs 2 and 3 shall be deleted. Article 3 1. The Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 31 December 1992. They shall forthwith inform the Commission thereof. When the Member States adopt such provisions they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 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 4 This Directive is addressed to the Member States.

31992L0084

1992

COUNCIL DIRECTIVE 92/84/EEC of 19 October 1992 on the approximation of the rates of excise duty on alcohol and alcoholic beverages Having regard to the Treaty instituting the European Economic Community, and in particular Article 99 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 Directive 92/12/EEC (4) lays down provisions on the general arrangements for products subject to excise duties; Whereas Directive 92/83/EEC (5) lays down provisions relating to the harmonization of the structures of excise duties on alcohol and alcoholic beverages; Whereas Member States should apply minimum rates of excise duty on these products by 1 January 1993 if the internal market is to be achieved by that date; Whereas the most appropriate basis for levying duty on ethyl alcohol is the volume of pure alcohol; Whereas the most appropriate basis for levying duty on wine and intermediate products is the volume on the finished product; Whereas the consumption pattern of sparkling wine differs from that of still wine; whereas, therefore, Member States may be allowed to charge differing rates of duty on the two products; Whereas the methods of taxing beer within the Member States vary, and it is possible to permit this variation to continue, in particular by laying down a minimum rate expressed as a charge related both to the original gravity and to the alcoholic content of the product; Whereas it is possible to permit certain Member States to apply reduced rates to products consumed within particular regions of their national territory; Whereas it is necessary for the rates laid down in this Directive to be reviewed periodically on the basis of a Commission report taking account of all the appropriate factors; Whereas a mechanism should be set up to enable specific amounts expressed in ecu to be converted into national currency, Article 1 Not later than 1 January 1993, Member States shall apply minimum rates of excise duty in accordance with the rules laid down in this Directive. Article 2 The products covered by this Directive are: — alcohol and alcoholic beverages, — intermediate products, — wine, — beer, as defined in Directive 92/83/EEC. Article 3 1. As from 1 January 1993, the minimum rate of excise duty on alcohol and alcohol contained in beverages other than those referred to in Articles 4, 5 and 6 shall be fixed at ECU 550 per hectolitre of pure alcohol. However, Member States which apply to alcohol and alcoholic beverages a rate of duty not exceeding ECU 1 000 per hectolitre of pure alcohol may not reduce their national rate. In addition Member States which apply to the said products a rate of duty exceeding ECU 1 000 per hectolitre of pure alcohol may not reduce their national rate below ECU 1 000. 2. The Kingdom of Denmark may, however, maintain its existing system of taxing alcohol and the alcohol contained in other products until 30 June 1996, provided that the application of that system never results in the application of a charge which falls below that which would arise from the application of paragraph 1 in accordance with the rules laid down in Directive 92/83/EEC. 3. The Italian Republik may, however, maintain its existing system of taxing alcohol and the alcohol contained in other products, which provides a reduced rate for some categories of alcohol, until 30 June 1996, provided that the application of that system never results in the application of a charge which falls below that which would arise from the application of paragraph 1 in accordance with the rules laid down in Council Directive 92/83/EEC. Article 4 As from 1 January 1993, the minimum rate of excise duty on intermediate products shall be fixed at ECU 45 per hectolitre of product. Article 5 As from 1 January 1993, the minimum rate of excise duty on wine shall be fixed: — for still wine at ECU 0, and — for sparkling wine at ECU 0 per hectolitre of product. Article 6 As from 1 January 1993, the minimum rate of excise duty on beer shall be fixed: — ECU 0,748 per hectolitre/degree Plato, or — ECU 1,87 per hectolitre/degree of alcohol of finished product. Article 7 1. The Hellenic Republic may apply a reduced rate of excise duty to ethyl alcohol consumed in the departments of Lesbos, Chios, Samos, the Dodecanese and the Cyclades and on the following islands in the Aegean: Thasos, Northern Sporades, Samothrace and Skiros. The reduced rate, which may fall below the minimum rate of duty, may not fall more than 50 % below the standard national rate of duty on ethyl alcohol. 2. The Italian Republic may continue to apply the exemptions and reduced rates of excise duty, which may fall below the minimum rates, which were applied on 1 January 1992 to alcohol and alcoholic drinks consumed in the regions of Gorizia and the Aosta valley. 3. The Portuguese Republik may continue to apply, in the autonomous regions of Madeira and the Azores, reduced rates of excise duty not falling more than 50 % below the national rates, on the following products: (a) in Madeira — wine obtained from the purely regional grape varieties specified in Article 15 of Regulation (EEC) No 4252/88, — rum as defined in Article 1 (4) (a) of Regulation (EEC) No 1576/89 having the geographical characteristics set out in Article 5 (3) and Annex II, point 1, of that Regulation, — liqueurs produced from sub-tropical fruit enriched with sugar cane eau-de-vie and having the characteristics and qualities defined in Article 5 (3) (b) of Regulation (EEC) No 1576/89; (b) in the Azores — liqueurs as defined in Article 1 (4) (r) of Regulation (EEC) No 1576/89 produced from passion fruit and pineapple, — eau-de-vie made from wine or from grape marc having the characteristics and qualities defined in Article 1 (4) (d) and (f) of Regulation (EEC) No 1576/89. Article 8 Every two years, and for the first time not later than 31 December 1994, the Council, acting on the basis of a report and, where appropriate, a proposal from the Commission, shall examine the rates of duty laid down herein and, acting unanimously after consulting the European Parliament, shall adopt the necessary measures. The report by the Commission and the consideration by the Council shall take into account the proper functioning of the internal market, competition between the different categories of alcoholic drinks, the real value of the rates of duty and the wider objectives of the Treaty. Article 9 1. The value of the ecu in national currencies to be applied to the value of specific excise duties shall be fixed once a year. The rates to be applied shall be those obtaining on the first working day of October and published in the Official Journal of the European Communities and shall have effect from 1 January of the following calendar year. 2. Member States may maintain the amounts of the excise duties in force at the time of the annual adjustment provided for in paragraph 1 if the conversion of the amounts of the excise duties expressed in ecu would result in an increase of less than 5 % or less than ECU 5, whichever is the lower amount, in the excise duty expressed in national currency. Article 10 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1992. 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 texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 11 This Directive is addressed to the Member States.

31992L0086

1992

Fifteenth Commission Directive 92/86/EEC of 21 October 1992 adapting to technical progress Annexes II, III, IV, V, VI and VII of Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Commission Directive 92/8/EEC (2), and in particular Article 8 (2) thereof, Whereas, on the basis of the available information, certain provisionally permitted colouring agents, substances, preservatives and ultraviolet filters may be definitively permitted, whilst others must be definitively prohibited or be permitted for a further specified period; Whereas, in order to protect public health, it is necessary to prohibit the use of 1,2-epoxybutane, CI 15585, strontium lactate, strontium nitrate, strontium polycarboxylate, pramocaine, 4-ethoxy-m-phenylenediamine and its salts, 2,4-diaminophenylethanol and its salts, catechol, pyrogallol, nitrosamines and dialkanolamines; Whereas, on the basis of the latest scientific and technical research, the use of strontium chloride, strontium acetate, fatty acid dialkanolamides, monoalkanolamines, trialkanolamines and hydrated magnesium silicate may be permitted subject to certain restrictions and conditions and the obligatory inclusion of health warnings on the label; Whereas, on the basis of the latest scientific and technical research, 3-iodo-2-propynylbutyl carbamate and sodium hydroxymethylaminoacetate may be used as preservatives in cosmetic products up to 30 June 1993 subject to certain restrictions and conditions; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector, Article 1 Directive 76/768/EEC is hereby amended as follows: 1. the following numbers are added to Annex II: '400. 1,2-epoxybutane 401. Colouring agent CI 15585 402. Strontium lactate 403. Strontium nitrate 404. Strontium polycarboxylate 405. Pramocaine 406. 4-ethoxy-m-phenylenediamine and its salts 407, 2,4-diaminophenylethanol and its salts 408. Catechol 409. Pyrogallol 410. Nitrosamines 411. Secondary dialkanolamines`; 2. in Annex III, Part 1: (a) the following reference numbers are added: >TABLE> (b) reference number 20 is deleted; (c) 'sensitivity test advisable before use` in column f (a) and (b) in reference numbers 8, 9 and 10 is deleted; (d) refence number 12 is replaced by the following number: >TABLE> 3. in Annex III, Part 2, reference number 2 is deleted; 4. in Annex IV, Part 1: (a) the following number is added: >TABLE> (b) 'see Annex IV, Part 2` in the column 'other limitations and requirements` is deleted in numbers CI 73900 and CI 74180; 5. in Annex IV, Part 2, colouring agents CI 26100, CI 73900, CI 74180, CI 15585 and Solvent Yellow 98 are deleted; 6. in Annex V, reference number 5 is replaced by the following: '5. Strontium and its compounds, with the exception of strontium lactate, strontium nitrate and strontium polycarboxylate listed in Annex II, strontium sulphide, strontium chloride and strontium acetate, under the conditions laid down in Annex III, Part 1, and of strontium lakes, pigments and salts of the colouring agents listed with reference (3) in Annex IV, Part 1.`; 7. in Annex VI, Part 1: (a) the limitation 'not to be used in cosmetic sunscreen products` in reference number 36 is replaced by 'not to be used in cosmetic sunscreen products at a concentration exceeding 0,025 %`; (b) the following substance is added: >TABLE> 8. in, Annex VI, Part 2: (a) '30. 6. 1992` in reference numbers 2, 21, 26, 27 is replaced by '30. 6. 1993`; (b) '31. 12. 1992` in reference number 28 is replaced by '30. 6. 1993`; (c) reference number 20 is deleted; (d) reference number 15 is replaced by the following: >TABLE> (e) reference number 16 is replaced by the following: >TABLE> (f) the following reference numbers are added: >TABLE POSITION> 9. in Annex VII, Part 2: (a) the following reference numbers are deleted: 1, 4 and 16; (b) '30. 6. 1992` is replaced by '30. 6. 1993` for the following reference numbers: 2, 5, 6, 12, 13, 17, 24, 25, 26, 28, 29, 31 and 32. Article 2 1. Notwithstanding the dates referred to in Article 1, Member States shall take all the necessary measures to ensure that as from 1 July 1993 for the substances referred to in Article 1, neither manufacturers nor importers established in the Community shall place on the market products which do not comply with the requirements of this Directive. 2. Member States shall take the necessary measures to ensure that the products referred to in paragraph 1 containing the substances referred to in Article 1 shall not be sold or otherwise disposed of to the final consumer as from 1 July 1994 if they do not comply with the requirements of this Directive. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions needed to comply with this Directive no later than 30 June 1993. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive is addressed to the Member States.

31992L0087

1992

Commission Directive 92/87/EEC of 26 October 1992 establishing a non-exclusive list of the main ingredients normally used and marketed for the preparation of compound feedingstuffs intended for animals other than pets Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs (1), as last amended by Directive 90/654/EEC (2), and in particular Article 10 (b) thereof, Whereas a nomenclature of goods meeting the requirements of both the Common Customs Tariff and the Community's external trade statistics was introduced by Council Regulation (EEC) No 2658/87 (3); Whereas, as regards labelling, the purpose of Directive 79/373/EEC is to ensure that stockfarmers are informed objectively and as accurately as possible; Whereas the declaration of the ingredients in feedingstuffs constitutes, in certain cases, an important item of information for stockfarmers; Whereas Directive 79/373/EEC provides for two forms of declaration of the ingredients of compound feedingstuffs for animals other than pets; Whereas, in accordance with Directive 79/373/EEC, as amended by Directive 90/44/EEC (4), and in view of progress in scientific and technical knowledge, a non-exclusive list should be drawn up of the main ingredients normally used and marketed for the manufacture of compound feedingstuffs for animals other than pets with a view to abolishing barriers to intra-Community trade; Whereas the list should establish a common name and description for each ingredient and may, in certain cases, establish minimum compositional requirements; Whereas a level of botanical purity and a definition of what is to be understood by botanical impurities must be determined in order for individual ingredients to be distinguished from mixtures; Whereas establishing a glossary describing the main manufacturing processes enables numerous repetitions to be avoided; Whereas ingredients included on the abovementioned list may be declared as such only under the names specified and on condition that they correspond to the descriptions therein and any compositional requirements which may be laid down; Whereas, in accordance with Directive 79/373/EEC, the list of ingredients which may be used in the manufacture of compound feedingstuffs cannot be exhaustive; whereas Member States are accordingly required to allow ingredients other than those on the list to be marketed provided that such products are of sound, genuine and merchantable quality and that they are declared using names other than those listed in the Annex which cannot mislead the purchaser; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs, Article 1 The Member States shall prescribe that in the case of compound feedingstuffs intended for animals other than pets, the ingredients listed at Part B of the Annex may be declared, on the packaging, on the container or on a label attached thereto, only under the names specified therein, and on condition that they correspond to the descriptions given therein and any compositional requirements which may be laid down. Furthermore, the Member States shall ensure that the provisions under 'General' of Part A of the Annex are respected. Article 2 Member States shall, however, lay down that compound feedingstuffs manufactured before 1 March 1993 which do not comply with this Directive may still be marketed until 31 December 1993. Article 3 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive by 1 March 1993 at the latest. They shall inform the Commission immediately thereof. The provisions to be adopted by the Member States shall contain a reference to this Directive or shall be accompanied by such a reference when they are published officially. The reference shall be as laid down by the Member States. Article 4 This Directive is addressed to the Member States.

31992L0088

1992

Council Directive 92/88/EEC of 26 October 1992 amending Directive 74/63/EEC on undesirable substances and products in animal nutrition Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 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 experience has demonstrated that there are grounds for amending certain provisions of Directive 74/63/EEC (4); Whereas, moreover, the restriction of the scope of Directive 74/63/EEC to animals belonging to species normally nourished and kept or consumed by man does not rule out the possibility that feedingstuffs containing undesirable substances or products might be distributed to animals living freely in the wild; Whereas it is accordingly advisable that the definition of the term 'animals' should in future cover species living freely in the wild in order that all feedingstuffs conform to the requirements prescribed by Directive 74/63/EEC; Whereas Directive 74/63/EEC must apply to raw materials and feedingstuffs from the date of their introduction into the Community; whereas it should therefore be stipulated that the maximum levels of undesirable substances or products set apply in general from the date on which the raw materials and feedingstuffs are put into circulation, including all stages of marketing, and in particular from the date of their importation; Whereas it is advisable to establish the principle that raw materials used in animal nutrition must be sound, genuine and of merchantable quality; whereas, therefore, it is necessary to prohibit the use or putting into circulation of raw materials which, because they contain too high a level of undesirable substances or products, result in the maximum levels for compound feedingstuffs laid down in Annex I to the Directive 74/63/EEC being exceeded; Whereas Directive 74/63/EEC set maximum levels for certain substances or products undesirable in certain raw materials; whereas, for such a restriction to have full effect, namely a reduction in the total quantity of undesirable substances ingested by animals, it is advisable to state clearly that the measure applies to all consignments immediately they are put into circulation in the Community; whereas it is therefore forbidden to mix severely contaminated consignements with other consignments of raw material or with consignemnts of feedingstuffs in order to comply: with the maximum levels set by the Directive 74/63/EEC; Whereas experience has shown that the information system introduced by the Directive 74/63/EEC within the official control departments should be improved so that Member States are also informed by operators of cases where the provisions of the Directive are not complied with; whereas, in such cases, Member States will be required to take all measures to enable use in animal nutrition to be excluded; whereas Member States will, if appropriate, be obliged to ensure that the effected consignments of raw materials or feedingstuffs is destroyed, if this has been decided by its owner; Whereas the Community should apply to exporters to third countries at least the same rules on health as apply within the Community, Article 1 Directive 74/63/EEC is hereby amended as follows: 1. Article 2 (f) shall be replaced by the following: '(f) animals: animals belonging to species normally nourished and kept or consumed by man as well as animals living freely in the wild in cases where they are nourished with feedingstuffs;'. 2. The following Article shall be inserted: 'Article 2a 1. Member States shall prescribe that raw materials may only be put into circulation in the Community if they are sound, genuine and of merchantable quality. 2. In particular, and subject ot the provisions in Part A of Annex II, raw materials cannot be considered as sound, genuine and of merchantable quality if the level of undesirable substances or products is so high as to make it impossible to respect the maximum levels fixed for compound feedingstuffs in Annex I.' 3. In Article 3a (1) and (2) the word 'marketed' shall each time be replaced by the words 'put into circulation'. 4. The following Article shall be added: 'Article 3c Member States shall prescribe that a consignment of a raw material detailed in Part A of Annex II with a content of an undesirable substance or product higher than the maximum level fixed in column 3 of the abovementioned Annex must not be mixed with other consignments of raw material or with consignments of feedingstuffs.' 5. In Article 7 the words 'marketing restrictions' shall be replaced by the words 'restrictions on their circulation'. 6. Article 8 shall be amended as follows: (a) the following paragraph shall be inserted: '2a. Member States shall prescribe that where an operator (importer, producer, etc.) or a person who, by virtue of his professional activities, possesses, or has possessed, or has had direct contact with a consignment of raw materials or of feedingstuffs and has knowledge to the effect that: - the consignment of raw materials is unsuitable for any use in animal feedingstuffs because of contamination by an undesirable substance or product covered by this Directive, and therefore does not meet the provisions of Article 2a (1) and consequently constitutes a serious risk for animal and public health; - the consignment of feedingstuffs does not meet the provisions of Annex I, and therefore constitutes a serious risk for animal and public health; such a person or operator shall immediately inform the official authorities even if the destruction of the consignment is envisaged. After verifying the information received, Member States shall ensure that, in the case of a contaminated consignment, the measures necessary are taken to ensure that the consignment is not used in animal nutrition. Member States shall ensure that the final destination of the contaminated consignment, including possible destruction, cannot have harmful effects on public or animal health or on the environment.' (b) Paragraph 3 shall be replaced by the following: '3. If a consignment of raw material or a consignment of feedingstuffs is likely to be sent to a Member State after it has been judged not to comply with the provisions of this Directive on account of an excessive content of undesirable substances or products in another Member State, the latter Member State shall immediately give the other Member States and the Commission any useful information concerning that consignment.' 7. Article 11 shall be replaced by the following: 'Article 11 1. The Member States shall apply at least the provisions of this Directive to feedingstuffs intended for export to third countries. 2. Paragraph 1 does not affect the right of Member States to allow the re-exportation to the exporting third country of consignments of feedingstuffs which do not fulfil the requirements of this Directive.' Article 2 Member States shall bring into force not later than 31 December 1993 the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive. They shall immediately 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. Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field governed by this Directive. Article 3 This Directive is addressed to the Member States.

31992L0090

1992

Commission Directive 92/90/EEC of 3 November 1992 establishing obligations to which producers and importers of plants, plant products or other objects are subject and establishing details for their registration Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), as last amended by Commission Directive 92/10/EEC (2), and in particular Article 6 (7), fourth indent, and Article 6 (8), Whereas the application of the Community plant health regime to the Community as an area without internal frontiers, will require the carrying out of plant health checks of Community products of plant health concern before their movement within the Community; whereas the most appropriate place for carrying out these checks is the place of production of producers listed in an official register; Whereas, with a view to the production of plants, plant products or other objects which are not infested or infected by harmful organisms referred to in Council Directive 77/93/EEC, and adequate monitoring by Member States of that production, it is necessary to establish more rules on the listing of producers or other persons for which the listing in an official register is required, as well as certain detailed and - to that extent - uniform obligations to which producers of plants, plant products or other objects should be subject; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 1. Member States shall ensure that any producer, collective warehouse, dispatching centre, other person or importer who come under Article 6 (4), third subparagraph, Article 6 (5), Article 10 (3), second indent or Article 12 (6), second subparagraph, of Directive 77/93/EEC respectively, shall enter an application for listing in an official register, through an appropriate registration procedure, to the responsible official bodies referred to in Directive 77/93/EEC. 2. Member States shall ensure that on receipt of the application referred to in paragraph 1, the said responsible official bodies shall record this application in an official register of applications and shall examine the information supplied in the application form. 3. The said responsible official bodies shall list each producer, collective warehouse, dispatching centre, other person or importer referred to in paragraph 1, in the official register mentioned in the same paragraph, under an individual registration number enabling their respective identification, once the said responsible official bodies have established that the producer, collective warehouse, dispatching centre, other person or importer is able and willing to meet the obligations laid down in Article 2 (2) and those referred to Article 2 (3) and Article 3. 4. In those cases, where, upon the examination referred to in paragraph 2 it is considered that the obligations referred to in Article 2 (2) will not be met, the said responsible official bodies shall not list the producer, collective warehouse, dispatching centre, other person or importer in the official register mentioned in paragraph 1 as long as paragraph 3 does not apply. 5. The Member States shall ensure that the listing shall be amended or renewed, as appropriate, if the producer, collective warehouse, dispatching centre, other person or importer referred to in paragraph 1 decides to carry out activities in addition to, or instead of, those for which he was initially listed. 6. The Member States shall ensure that the said responsible official bodies shall take the necessary measures if the obligations referred to in Article 2 (2), and where appropriate Article 2 (3) and Article 3, cease to be met. 7. Any measure taken under paragraph 6 shall be withdrawn as soon as it has been established that the producer, collective warehouse, dispatching centre, other person or importer is likely, in the future, to comply with the requirements and conditions of this Directive. Article 2 1. The Member States shall ensure that under the registration procedure, referred to in Article 1, any producer, collective warehouse, dispatching centre, other person or importer concerned shall be subject to the obligations laid down in paragraph 2, without prejudice to those referred to in paragraph 3 and in Article 3. 2. The obligations referred to in paragraph 1 shall be as follows, without prejudice to those already laid down in Directive 77/93/EEC: (a) to keep an updated plan of the premises on which plants, plant products or other objects are grown, produced, stored, kept or used by the producer or collective warehouses or dispatching centres, person or importer referred to in Article 1 (1), or are otherwise present; (b) to keep records, with a view to having complete information available for the said responsible official bodies, on plants, plant products or other objects, - purchased for storage or planting on the premises, - under production, or - dispatched to others, and to keep related documents for at least one year; (c) to be available personally or to designate another person technically experienced in plant production and related plant health matters, to liaise with the said responsible official bodies; (d) to carry out visual observations as necessary and at appropriate times, and in a manner laid down in guideline instructions given by the said responsible official bodies; (e) to ensure access for persons entitled to act for the said responsible official bodies, in particular for inspection and/or sampling, and to the records referred to in point (b) and related documents; (f) to otherwise cooperate with the said responsible official bodies. 3. Additional obligations of a general nature may be set up to facilitate the assessment of the plant health situation on the premises; they shall be within the limits of national law and may take into account the details of the production and, where appropriate import conditions, in particular the type of crop, the location, the size, the management, the staffing and the equipment. Article 3 The producer, collective warehouse, dispatching centre, other person or importer listed shall meet, at the request of the said responsible official bodies, specific obligations relating to the assessment or improvement of the plant health situation of the premises and to safeguarding the identity of material until the plant passport is attached pursuant to Article 10 (2) of Directive 77/93/EEC; these specific obligations may include activities such as special examination, sampling, isolation, roguing, treatment, destruction and marking (labelling) and any other measure which is specifically required under Annex IV, part A, section II, or Annex IV, part B, where appropriate, of Directive 77/93/EEC. Article 4 Member States shall ensure compliance with the obligations referred to in Article 2 (2) by examining periodically, at least once a year, the records and related documents as described in Article 2 (2) (b). Article 5 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive on the date referred to in Article 3 (1) of Council Directive 91/683/EEC (3). They shall forthwith inform the Commission thereof. 2. 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. 3. Member States shall immediately communicate to the Commission all provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 6 This Directive is addressed to the Member States.

31992L0089

1992

Commission Directive 92/89/EEC of 3 November 1992 amending Annex I to Fourth Directive 73/46/EEC establishing Community methods of analysis for the official control of feedingstuffs Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs (1), as last amended by Regulation (EEC) No 3768/85 (2), and in particular Article 2 thereof, Whereas Fourth Commission Directive 73/46/EEC (3), as amended by Directive 81/680/EEC (4), prescribes the method to be used for the determination of crude fibre; Whereas there are grounds to adapt this method in the light of advances in scientific and technical knowledge; whereas it is advisable, in particular, to take account of the provisions of Council Directive 80/1107/EEC of 27 November 1980 on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (5), as amended by Directive 88/642/EEC (6), and, in particular, the measures taken to prevent exposure to asbestos; Whereas it is from now on necessary to replace asbestos by glass containers in order to carry out the filtration procedures; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs, Article 1 Annex I to Directive 73/46/EEC is amended in accordance with this Directive. Article 2 Member States shall bring into force not later than 1 October 1993 the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States. Article 3 This Directive is addressed to the Member States.

31992L0091

1992

COUNCIL DIRECTIVE 92/91/EEC of 3 November 1992 concerning the minimum requirements for improving the safety and health protection of workers in the mineral-extracting industries through drilling (eleventh individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) Having regard to the Treaty establishing the European Economic Community, and in particular Article 118a thereof, Having regard to the proposal from the Commission (1), drawn up after consultation with the Safety and Health Commission for the Mining and other Extractive Industries, In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Article 118a of the EEC Treaty provides that the Council shall adopt, by means of Directives, minimum requirements for encouraging improvements, especially in the working environment, to guarantee a better level of protection of the safety and health of workers; Whereas, pursuant to that Article, such Directives must avoid imposing administrative, financial and legal constraints which would hold back the creation and development of small and medium-sized undertakings; Whereas the improvement of workers' safety, hygiene and health at work is an objective which should not be subordinated to purely economic considerations; Whereas Council Directive 89/654/EEC of 30 November 1989 concerning the minimum safety and health requirements for the workplace (first individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC (4)) does not apply to the extractive industries; Whereas compliance with the minimum requirements designed to guarantee a better standard of safety and health for the mineral-extracting industries through drilling is essential to ensure the safety and health of workers; Whereas the mineral-extracting industries through drilling constitute an area of activity likely to expose workers to particularly high levels of risk; Whereas this Directive is an individual directive within the meaning of Article 16 (1) of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (5); whereas, therefore, the provisions of the said Directive apply in full to the mineral-extracting industries through drilling without prejudice to more stringent and/or specific provisions contained in this Directive; Whereas this Directive is a practical contribution towards creating the social dimension of the internal market, SECTION 1 GENERAL PROVISIONS Article 1 Subject 1. This Directive, which is the eleventh individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC, lays down minimum requirements for the safety and health protection of workers in the mineral-extracting industries through drilling defined in Article 2 (a). 2. The provisions of Directive 89/391/EEC shall apply in full to the sphere referred to in paragraph 1, without prejudice to more stringent and/or specific provisions contained in this Directive. Article 2 Definitions For the purpose of this Directive: (a) mineral-extracting industries through drilling shall mean all the industries practising: — extraction, in the strict sense of the word, of minerals through drilling by boreholes, and/or — prospection with a view to such extraction, and/or — preparation of extracted materials for sale, excluding the activities of processing the materials extracted; (b) workplace shall mean the whole area intended to house workstations, relating to the immediate and ancillary activities and installations of the mineral-extracting industries through drilling, including accommodation, where provided, to which workers have access in the context of their work. SECTION II EMPLOYERS' OBLIGATIONS Article 3 General obligations 1. To safeguard the safety and health of workers, the employer shall take the necessary measures to ensure that: (a) workplaces are designed, constructed, equipped, commissioned, operated and maintained in such a way that workers can perform the work assigned to them without endangering their safety and/or health and/or those of other workers; (b) the operation of workplaces when workers are present takes place under the supervision of a person in charge; (c) work involving a special risk is entrusted only to competent staff and carried out in accordance with the instructions given; (d) all safety instructions are comprehensible to all the workers concerned; (e) appropriate first-aid facilities are provided; (f) any relevant safety drills are performed at regular intervals. 2. The employer shall ensure that a document concerning safety and health, hereinafter referred to as ‘safety and health document’, covering the relevant requirements laid down in Articles 6, 9 and 10 of Directive 89/391 /EEC, is drawn up and kept up to date. The safety and health document shall demonstrate in particular: — that the risks incurred by the workers at the work place have been determined and assessed, — that adequate measures will be taken to attain the aims of this Directive, — that the design, use and maintenance of the workplace and of the equipment are safe. The safety and health document must be drawn up prior to the commencement of work and be revised if the workplace has undergone major changes, extensions or conversions. 3. Where workers from several undertakings are present at the same workplace, each employer shall be responsible for all matters under his control. The employer who, in accordance with national laws and /or practices, is in charge of the workplace, shall coordinate the implementation of all the measures concerning the safety and health of the workers and shall state, in his safety and health document, the aim of that coordination and the measures and procedures for implementing it. The coordination shall not affect the responsibility of the individual employers as provided for in Directive 89/391/EEC. 4. The employer shall, without delay, report any serious and /or fatal occupational accidents and situations of serious danger to the competent authorities. If necessary, the employer shall update the safety and health document recording measures taken to avoid any repetition. Article 4 Protection from fire, explosions and health-endangering atmospheres The employer shall take measures and precautions appropriate to the nature of the operation: — to avoid, detect and combat the starting and spread of fires and explosions, and — to prevent the occurance of explosive and/or health-endangering atmospheres. Article 5 Escape and rescue facilities The employer shall provide and maintain appropriate means of escape and rescue in order to ensure that workers have adequate opportunities for leaving the workplaces promptly and safely in the event of danger. Article 6 Communication, warning and alarm systems The employer shall take the requisite measures to provide the necessary warning and other communication systems to enable assistance, escape and rescue operations to be launched immediately if the need arises. Article 7 Keeping workers informed 1. Without prejudice to Article 10 of Directive 89/391/EEC, workers and/or their representatives shall be informed of all measures to be taken concerning safety and health at workplaces, and in particular of those relating to the implementation of Article 3 to 6. 2. The information must be comprehensible to the workers concerned. Article 8 Health surveillance 1. To ensure that workers receive health surveillance appropriate to the health and safety risks they incur at work, measures shall be introduced in accordance with national law and/or practices. 2. The measures referred to in paragraph 1 shall be such that each worker shall be entitled to or shall undergo health surveillance before being assigned to duties related to the activities referred to in Article 2 and subsequently at regular intervals. 3. Health surveillance may be provided as part of a national health system. Article 9 Consultation of workers and workers' participation Consultation and participation of workers and/or of their representatives shall take place in accordance with Article 11 of Directive 89/391 /EEC on the matters covered by this Directive. Article 10 Minimum requirements for safety and health 1. Workplaces used for the first time after the date on which this Directive is brought into effect as referred to in Article 12 (1) must satisfy the minimum safety and health requirements laid down in the Annex. 2. Workplaces already in use before the date on which this Directive is brought into effect as referred to in Article 12 (1) must satisfy the minimum safety and health requirements laid down in the Annex as soon as possible and at the latest five years after that date. 3. When workplaces undergo changes, extensions and /or conversions after the date on which this Directive is brought into effect as referred to in Article 12 (1), the employer shall take the measures necessary to ensure that those changes, extensions and/or conversions are in compliance with the corresponding minimum requirements laid down in the Annex. SECTION III OTHER PROVISIONS Article 11 Adjustments to the Annexes Purely technical adjustments to the Annexes in line with: — the adoption of Directives in the field of technical harmonization and standardization concerning the mineral-extracting industries through drilling, and/or — technical progress, changes in international regulations or specifications, and new findings concerning the mineral-extracting industries through drilling, shall be adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC. Article 12 Final provisions 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 24 months after its adoption. They shall forthwith inform the Commission thereof. 2. When Member States adopt the provisions referred to in paragraph 1, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 3. Member States shall communicate to the Commission the texts of the provisions of national law which they have already adopted or are adopt in the field governed by this Directive. 4. Member States shall report to the Commission every five years on the practical implementation of this Directive, indicating the views of employers and workers. The Commission shall inform the European Parliament, the Council, the Economic and Social Committee, the Safety and Health Commission for the Mining and Other Extractive Industries and the Advisory Committee on Safety, Hygiene and Health Protection at Work thereof. Article 13 This Directive is addressed to the Member States.

31992L0095

1992

Commission Directive 92/95/EEC of 9 November 1992 amending the Annex to the Seventh Directive 76/372/EEC establishing Community methods of analysis for the official control of feedingstuffs Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs (1), as last amended by the Acts of Accession of Spain and Portugal, and in particular Article 2 thereof, Whereas the Seventh Commission Directive 76/372/EEC of 1 March 1976 establishing Community methods of analysis for the official control of feedingstuffs (2), as amended by Directive 81/680/EEC (3), prescribes the methods to be used for the determination of aflatoxin B1; Whereas there are grounds for adapting these methods in the light of advances in scientific and technical knowledge; whereas it is advisable particularly to have available a method of controlling the very low limits for aflatoxin fixed by Council Directive 74/63/EEC of 17 December 1973 on the fixing of maximum permitted levels for undesirable substances and products in animal nutrition (4), as last amended by Directive 91/132/EEC (5); Whereas it is also advisable to have available a method of determining aflatoxin B1 in the presence of interfering substances, such as citrus pulp; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs, Article 1 The Annex to Directive 76/372/EEC is amended in accordance with the Annex to this Directive. Article 2 Member States shall bring into force not later than 1 October 1993 the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive. They shall fortwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States. Article 3 This Directive is addressed to the Member States.

31992L0097

1992

Council Directive 92/97/EEC of 10 November 1992 amending Directive 70/157/EEC on the approximation of the laws of the Member States relating to the permissible sound level and the exhaust system of motor vehicles 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 measures should be adopted with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market will comprise an area without internal frontiers in which the free movement of goods, persons, services and capital will be ensured; Whereas the European Parliament has already called on the Commission to submit a proposal in 1992 laying down the maximum permissible noise limits taking account of the noise disturbance thresholds defined by the Organization for Economic Cooperation and Development (OECD); Whereas Council Directive 70/157/EEC (4) lays down limit values for the sound level of motor vehicles; whereas these limit values were reduced for the first time by Directive 77/212/EEC (5) and for the second time by Directive 84/424/EEC (6); whereas these reductions were particularly severe in the case of motor buses, motor coaches and lorries, amounting to approximately 10 decibels (dB (A)); Whereas Council Directive 70/157/EEC is one of the separate directives of the EEC type-approval procedure established by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (7); Whereas the Council, in adopting Directive 84/424/EEC amending Directive 70/157/EEC, decided that the provisions of the Directive would later be reviewed on a proposal from the Commission; whereas the proposal from the Commission was based on studies and research concerning possible further legislative measures taking account simultaneously of all the main aspects of Community rules in the motor-vehicle sector, in particular those relating to safety, environmental protection and energy conservation; Whereas the protection of the public against noise pollution requires additional suitable measures to reduce still further the sound level of motor vehicles; whereas such measures must take account of the technological advances to be applied; whereas enough time must consequently be allowed for their implementation after adoption of this Directive so that the technological advances, at present at the prototype stage, can be applied to series production; whereas the limit values currently applicable to heavy goods vehicles took effect only from 1 October 1989; Whereas achievement of a significant and effective reduction of such nuisances will require that the differences between the measuring techniques in current use and the actual traffic conditions be reduced to the maximum extent possible; whereas certain types of technology cannot yet be verified and are not yet comparable with those used hitherto in the type-approval procedures for motor vehicles; Whereas the current measuring conditions, and in particular the definition of the surface of the test track and certain ambient conditions during the tests, such as temperature, atmospheric pressure, humidity, wind speed and background noise require more detailed description; whereas those closer details will be provided as soon as possible by means of the procedure referred to in Article 13 of Directive 70/156/EEC; Whereas, of the noise pollution emanating from vehicles, that caused by the tyres has proved to be particularly severe when the vehicles' speed exceeds 60 km/h; whereas protecting the public effectively against noise pollution, particularly that caused by traffic in urban areas, requires that two further stages be completed; whereas the first stage, covered by this Directive, consists in giving as much additional weight as possible to the current requirements for each category of vehicle with respect to the sound levels of the mechanical parts and exhaust systems of motor vehicles; whereas the second stage - in the light of further, more detailed studies and research on the problems associated with, and the technical solutions for noise created by, the contact between tyres and the road surface - will result in the establishment of realistic and reproducible criteria and methods for determining this important type of noise pollution and for laying down the corresponding requirements to be complied with; Whereas completion of the first stage requires that Annex I to Directive 70/157/EEC be amended by reducing the sound-level values expressed in dB (A) for each category of vehicle referred to in the said Annex and by improving the test method for high-powered vehicles; whereas this type of vehicle is increasingly being designed so as to produce a higher ratio between engine power and vehicle mass and the curve representing the torque as a function of engine speed has been modified to produce greater motive force at low engine speed; whereas these new designs consequently give rise to greater use of gear ratios in urban traffic and have a major influence on the noise emitted by the mechanical parts as compared with road noise; whereas account has been taken of these new designs by modifying the measuring technique for this type of vehicle, due allowance having been made for the speed of approach to the acceleration section where the sound level is to be measured; Whereas, given the many different types of tyre and road surface which exist and which correspond to the different geographical and atmospheric conditions, it is necessary to continue studies and research so as to be able to establish criteria to be met by tyres and to define a numerical value for the type-approval of motor vehicles; whereas the results of such studies and research will permit the introduction, at a second stage, of further requirements, in addition to measures covering noise of mechanical source; Whereas the control of sound emissions produced by the interaction between tyres and roadway must be based not only on tyres but also on the composition of the asphalt (noise-absorbing asphalt); whereas it is necessary to continue studies and research so as to be able to ascertain numerical indices in order to establish objective criteria for road conformity; Whereas Member States should be allowed to advance the authorization for introduction of vehicles which satisfy the Community standards by means of tax incentives; whereas this implies that the Council should, by 1 October 1995, adopt the requirements for the second stage, for which the Commission will present a proposal by 31 March 1994; Whereas, to enable the European environment to obtain maximum benefit from these provisions while at the same time ensuring the unity of the market, it is necessary to lay down stricter European standards based on total harmonization, Article 1 The Annexes to Directive 70/157/EEC are hereby replaced by the Annexes to this Directive. Article 2 1. With effect from 1 July 1993, Member States may not, on grounds relating to the permissible sound level and the exhaust system: - refuse, in respect of a type of motor vehicle, to grant EEC type-approval, to issue the document referred to in the last indent of Article 10 (1) of Directive 70/156/EEC, or to grant national type-approval, or - prohibit the initial entry into service of vehicles, if the sound level and the exhaust system of this type of vehicle or of these vehicles comply with the requirements of Directive 70/157/EEC as amended by this Directive. 2. With effect from 1 October 1995, Member States: - may no longer grant EEC type-approval or issue the document referred to in the last indent of Article 10 (1) of Directive 70/156/EEC in respect of a type of motor vehicle, - must refuse to grant national type-approval in respect of a type of motor vehicle, of which the sound level and the exhaust system do not comply with the requirements set out in the Annexes to Directive 70/157/EEC as amended by this Directive. 3. With effect from 1 October 1996, Member States shall prohibit the initial entry into service of motor vehicles of which the sound level and the exhaust systems do not comply with the requirements set out in the Annexes to Directive 70/157/EEC as amended by this Directive. Article 3 Member States may make provision for tax incentives only in respect of motor vehicles which comply with this Directive. Such incentives must comply with the provisions of the Treaty and, in addition, must meet the following conditions: - they must apply to all nationally-manufactured motor vehicles and all imported vehicles which are offered for sale on the market of a Member State and which meet, in advance, the requirements of this Directive due to be complied with in 1995, - they shall be terminated with effect from the mandatory application of the sound level values laid down in Article 2 (3) for new motor vehicles, - in respect of each type of motor vehicle, they must represent an amount substantially below the additional cost of the technical solutions introduced to ensure compliance with the established values and of their installation on the vehicle. The Commission must be informed in good time of plans to institute or change tax incentives as referred to in the first subparagraph. The Commission must give its consent before such incentives are put into effect and must, in particular, take into account the impact of such incentives on the internal market. Article 4 1. Specific details on the conditions of measurement shall be supplied as soon as possible via the procedure referred to in Article 13 of Directive 70/156/EEC. 2. Subsequent measures intended, in particular, to reconcile safety requirements with the need to limit the noise arising from contact between tyres and the road surface shall be decided upon before 1 October 1995 by the Council acting by a qualified majority on the basis of a proposal from the Commission, which shall take account of the studies and research to be performed on this source of noise, and shall be presented by 31 March 1994. 3. Member States shall take the necessary measures to have the type-approval sound level values published in such a way as to make them widely accessible, before 1 October 1994. They shall inform the Commission before this date of the steps taken to comply with this requirement. Article 5 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1993. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or 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. 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 6 This Directive is addressed to the Member States.

31992L0096

1992

Council Directive 92/96/EEC of 10 November 1992 on the coordination of laws, regulations and administrative provisions relating to direct life assurance and amending Directives 79/267/EEC and 90/619/EEC (third life assurance Directive) Having regard to the Treaty establishing the European Economic Community, and in particular Articles 57 (2) and 66 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), 1. Whereas it is necessary to complete the internal market in direct life assurance, from the point of view both of the right of establishment and of the freedom to provide services, to make it easier for assurance undertakings with head offices in the Community to cover commitments situated within the Community; 2. Whereas the Second Council Directive 90/619/EEC of 8 November 1990 on the coordination of laws, regulations and administrative provisions relating to direct life assurance, laying down provisions to facilitate the effective exercise of freedom to provide services and amending Directive 79/267/EEC (4) has already contributed substantially to the achievement of the internal market in direct life assurance by granting policy-holders who, by virtue of the fact that they take the initiative in entering into a commitment with an assurance undertaking in another Member State, do not require special protection in the Member State of the commitment complete freedom to avail themselves of the widest possible life assurance market; 3. Whereas Directive 90/619/EEC therefore represents an important stage in the merging of national markets into an integrated market and that stage must be supplemented by other Community instruments with a view to enabling all policy-holders, irrespective of whether they themselves take the initiative, to have recourse to any assurer with a head office in the Community who carries on business there, under the right of establishment or the freedom to provide services, while guaranteeing them adequate protection; 4. Whereas this Directive forms part of the body of Community legislation already enacted which includes the First Council Directive 79/267/EEC of 5 March 1979 on the coordination of laws, regulations and administrative provisions relating to the taking up and pursuit of the business of direct life assurance (5) and Council Directive 91/674/EEC of 19 December 1991 on the annual accounts and consolidated accounts of insurance undertakings (6); 5. Whereas the approach adopted consists in bringing about such harmonization as is essential, necessary and sufficient to achieve the mutual recognition of authorizations and prudential control systems, thereby making it possible to grant a single authorization valid throughout the Community and apply the principle of supervision by the home Member State; 6. Whereas, as a result, the taking up and the pursuit of the business of assurance are henceforth to be subject to the grant of a single official authorization issued by the competent authorities of the Member State in which an assurance undertaking has its head office; whereas such authorization enables an undertaking to carry on business throughout the Community, under the right of establishment or the freedom to provide services; whereas the Member State of the branch or of the provision of services may no longer require assurance undertakings which wish to carry on assurance business there and which have already been authorized in their home Member State to seek fresh authorization; whereas Directives 79/267/EEC and 90/619/EEC should therefore be amended along those lines; 7. Whereas the competent authorities of home Member States will henceforth be responsible for monitoring the financial health of assurance undertakings, including their state of solvency, the establishment of adequate technical provisions and the covering of those provisions by matching assets; 8. Whereas the performance of the operations referred to in Article 1 (2) (c) of Directive 79/267/EEC cannot under any circumstances affect the powers conferred on the respective authorities with regard to the entities holding the assets with which that provision is concerned; 9. Whereas certain provisions of this Directive define minimum standards; whereas a home Member State may lay down stricter rules for assurance undertakings authorized by its own competent authorities; 10. Whereas the competent authorities of the Member States must have at their disposal such means of supervision as are necessary to ensure the orderly pursuit of business by assurance undertakings throughout the Community whether carried on under the right of establishment or the freedom to provide services; whereas, in particular, they must be able to introduce appropriate safeguards or impose sanctions aimed at preventing irregularities and infringements of the provisions on assurance supervision; 11. Whereas the provisions on transfers of portfolios must be adapted to bring them into line with the single legal authorization system introduced by this Directive; 12. Whereas provision should be made for the specialization rule laid down by Directive 79/267/EEC to be relaxed so that those Member States which so wish are able to grant the same undertaking authorizations for the classes referred to in the Annex to Directive 79/267/EEC and the insurance business coming under classes 1 and 2 in the Annex to Directive 73/239/EEC (7); whereas that possibility may, however, be subject to certain conditions as regards compliance with accounting rules and rules on winding-up; 13. Whereas it is necessary from the point of view of the protection of lives assured that every assurance undertaking should establish adequate technical provisions; whereas the calculation of such provisions is based for the most part on actuarial principles; whereas those principles should be coordinated in order to facilitate mutual recognition of the prudential rules applicable in the various Member States; 14. Whereas it is desirable, in the interests of prudence, to establish a minimum of coordination of rules limiting the rate of interest used in calculating the technical provisions; whereas, for the purposes of such limitation, since existing methods are all equally correct, prudential and equivalent, it seems appropriate to leave Member States a free choice as to the method to be used; 15. Whereas the rules governing the spread, localization and matching of the assets used to cover technical provisions must be coordinated in order to facilitate the mutual recognition of Member States' rules; whereas that coordination must take account of the measures on the liberalization of capital movements provided for in Council Directive 88/361/EEC of 24 June 1988 for the implementation of Article 67 of the Treaty (8) and the progress made by the Community towards economic and monetary union; 16. Whereas, however, the home Member State may not require assurance undertakings to invest the assets covering their technical provisions in particular categories of assets, as such a requirement would be incompatible with the measures on the liberalization of capital movements provided for in Directive 88/361/EEC; 17. Whereas, pending the adoption of a directive on investment services harmonizing inter alia the definition of the concept of a regulated market, for the purposes of this Directive and without prejudice to such future harmonization that concept must be defined provisionally, to be replaced by the definition harmonized at Community level, which will give the home Member State of the market the responsibilities for these matters which this Directive transitionally gives to the assurance undertaking's home Member State; 18. Whereas the list of items of which the solvency margin required by Directive 79/267/EEC may be made up must be supplemented to take account of new financial instruments and of the facilities granted to other financial institutions for the constitution of their own funds; 19. Whereas the harmonization of assurance contract law is not a prior condition for the achievement of the internal market in assurance; whereas, therefore, the oppportunity afforded to the Member States of imposing the application of their law to assurance contracts covering commitments within their territories is likely to provide adequate safeguards for policy-holders; 20. Whereas within the framework of an internal market it is in the policy-holder's interest that he should have access to the widest possible range of assurance products available in the Community so that he can choose that which is best suited to his needs; whereas it is for the Member State of the commitment to ensure that there is nothing to prevent the marketing within its territory of all the assurance products offered for sale in the Community as long as they do not conflict with the legal provisions protecting the general good in force in the Member State of the commitment and in so far as the general good is not safeguarded by the rules of the home Member State, provided that such provisions must be applied without discrimination to all undertakings operating in that Member State and be objectively necessary and in proportion to the objective pursued; 21. Whereas the Member States must be able to ensure that the assurance products and contract documents used, under the right of establishment or the freedom to provide services, to cover commitments within their territories comply with such specific legal provisions protecting the general good as are applicable; whereas the systems of supervision to be employed must meet the requirements of an internal market but their employment may not constitute a prior condition for carrying on assurance business; whereas, from this standpoint, systems for the prior approval of policy conditions do not appear to be justified; whereas it is therefore necessary to provide for other systems better suited to the requirements of an internal market which enable every Member State to guarantee policy-holders adequate protection; 22. Whereas, for the purposes of implementing actuarial principles in conformity with this Directive, the home Member State may nevertheless require systematic notification of the technical bases used for calculating scales of premiums and technical provisions, with such notification of technical bases excluding notification of the general and special policy conditions and the undertaking's commercial rates; 23. Whereas in a single assurance market the consumer will have a wider and more varied choice of contracts; whereas, if he is to profit fully from this diversity and from increased competition, he must be provided with whatever information is necessary to enable him to choose the contract best suited to his needs; whereas this information requirement is all the more important as the duration of commitments can be very long; whereas the minimum provisions must therefore be coordinated in order for the consumer to receive clear and accurate information on the essential characteristics of the products proposed to him as well as the particulars of the bodies to which any complaints of policy-holders, assured persons or beneficiaries of contracts may be addressed; 24. Whereas publicity for assurance products is an essential means of enabling assurance business to be carried on effectively within the Community; whereas it is necessary to leave open to assurance undertakings the use of all normal means of advertising in the Member State of the branch or of provision of services; whereas Member States may nevertheless require compliance with their national rules on the form and content of advertising, whether laid down pursuant to Community legislation on advertising or adopted by Member States for reasons of the general good; 25. Whereas, within the framework of the internal market, no Member State may continue to prohibit the simultaneous carrying on of assurance business within its territory under the right of establishment and the freedom to provide services; whereas the option granted to Member States in this connection by Directive 90/619/EEC should therefore be abolished; 26. Whereas provision should be made for a system of penalties to be imposed when, in the Member State in which the commitment is entered into, an assurance undertaking does not comply with those provisions protecting the general good that are applicable to it; 27. Whereas some Member States do not subject assurance transactions to any form of indirect taxation, while the majority apply special taxes and other forms of contribution; whereas the structures and rates of such taxes and contributions vary considerably between the Member States in which they are applied; whereas it is desirable to prevent existing differences leading to distortions of competition in assurance services between Member States; whereas, pending subsequent harmonization, application of the tax systems and other forms of contribution provided for by the Member States in which commitments entered into are likely to remedy that problem and it is for the Member States to make arrangements to ensure that such taxes and contributions are collected; 28. Whereas it is important to introduce Community coordination on the winding-up of assurance undertakings; whereas it is henceforth essential to provide, in the event of the winding-up of an assurance undertaking, that the system of protection in place in each Member State must guarantee equality of treatment for all assurance creditors, irrespective of nationality and of the method of entering into the commitment; 29. Whereas technical adjustments to the detailed rules laid down in this Directive may be necessary from time to time to take account of the future development of the assurance industry; whereas the Commission will make such adjustments as and when necessary, after consulting the Insurance Committee set up by Directive 91/675/EEC (9), in the exercise of the implementing powers conferred on it by the Treaty; 30. Whereas it is necessary to adopt specific provisions intended to ensure smooth transition from the legal arrangements in existence when this Directive becomes applicable to those that it introduces; whereas care should be taken in such provisions not to place an additional workload on Member States' competent authorities; 31. Whereas, pursuant to Article 8c of the Treaty, account should be taken of the extent of the effort which must be made by certain economies at different stages of development; whereas, therefore, transitional arrangements should be adopted for the gradual application of this Directive by certain Member States, TITLE I DEFINITIONS AND SCOPE Article 1 For the purposes of this Directive: (a) assurance undertaking shall mean an undertaking which has received official authorization in accordance with Article 6 of Directive 79/267/EEC; (b) branch shall mean an agency or branch of an assurance undertaking, having regard to Article 3 of Directive 90/619/EEC; (c) commitment shall mean a commitment represented by one of the kinds of insurance or operations referred to in Article 1 of Directive 79/267/EEC; (d) home Member State shall mean the Member State in which the head office of the assurance undertaking covering the commitment is situated; (e) Member State of the branch shall mean the Member State in which the branch covering the commitment is situated; (f) Member State of the provision of services shall mean the Member State of the commitment, as defined in Article 2 (e) of Directive 90/619/EEC, if the commitment is covered by an assurance undertaking or a branch situated in another Member State; (g) control shall mean the relationship between a parent undertaking and a subsidiary, as defined in Article 1 of Directive 83/349/EEC (¹), or a similar relationship between any natural or legal person and an undertaking; (¹) Seventh Council Directive 83/349/EEC of 13 June 1983 based on Article 54 (3) (g) of the Treaty on consolidated accounts (OJ No L 193, 18. 7. 1983, p. 1). Directive as last amended by Directive 90/605/EEC (OJ No L 317, 16. 11. 1990, p. 60). (h) qualifying holding shall mean a direct or indirect holding in an undertaking which represents 10 % or more of the capital or of the voting rights or which makes it possible to exercise a significant influence over the management of the undertaking in which a holding subsists. For the purposes of this definition, in the context of Articles 7 and 14 and of the other levels of holding referred to in Article 14, the voting rights referred to in Article 7 of Directive 88/627/EEC (¹) shall be taken into consideration; (i) parent undertaking shall mean a parent undertaking as defined in Articles 1 and 2 of Directive 83/349/EEC; (j) subsidiary shall mean a subsidiary undertaking as defined in Articles 1 and 2 of Directive 83/349/EEC; any subsidiary of a subsidiary undertaking shall also be regarded as a subsidiary of the undertaking which is those undertakings' ultimate parent undertaking; (k) regulated market shall mean a financial market regarded by an undertaking's home Member State as a regulated market pending the adoption of a definition in a Directive on investment services and characterized by: - regular operation, and - the fact that regulations issued or approved by the appropriate authorities define the conditions for the operation of the market, the conditions for access to the market and, where Council Directive 79/279/EEC of 5 March 1979 coordinating the conditions for the admission of securities to official stock-exchange listing (²) applies, the conditions for admission to listing imposed in that Directive or, where that Directive does not apply, the conditions to be satisfied by a financial instrument in order to be effectively dealt in on the market. For the purposes of this Directive, a regulated market may be situated in a Member State or in a third country. In the latter event, the market must be recognized by the undertaking's home Member State and meet comparable requirements. Any financial instruments dealt in must be of a quality comparable to that of the instruments dealt in on the regulated market or markets of the Member State in question; (¹) Council Directive 88/627/EEC of 12 December 1988 on the information to be published when a major holding in a listed company is acquired or disposed of (OJ No L 348, 17. 12. 1988, p. 62). (²) OJ No L 66, 13. 3. 1979, p. 21. Directive as last amended by Directive 82/148/EEC (OJ No L 62, 5. 3. 1982, p. 22). (l) competent authorities shall mean the national authorities which are empowered by law or regulation to supervise assurance undertakings. Article 2 1. This Directive shall apply to the commitments and undertakings referred to in Article 1 of Directive 79/267/EEC. 2. In Article 1 (2) of Directive 79/267/EEC the words 'and are authorized in the country concerned' shall be deleted. 3. This Directive shall apply neither to classes of insurance or operations nor to undertakings or institutions to which Directive 79/267/EEC does not apply, nor shall it apply to the bodies referred to in Article 4 of that Directive. TITLE II THE TAKING-UP OF THE BUSINESS OF LIFE ASSURANCE Article 3 Article 6 of Directive 79/267/EEC shall be replaced by the following: 'Article 6 The taking-up of the activities covered by this Directive shall be subject to prior official authorization. Such authorization shall be sought from the authorities of the home Member State by: (a) any undertaking which establishes its head office in the territory of that State; (b) any undertaking which, having received the authorization required in the first subparagraph, extends its business to an entire class or to other classes.' Article 4 Article 7 of Directive 79/267/EEC shall be replaced by the following: 'Article 7 1. Authorization shall be valid for the entire Community. It shall permit an undertaking to carry on business there, under either the right of establishment or freedom to provide services. 2. Authorization shall be granted for a particular class of assurance as listed in the Annex. It shall cover the entire class, unless the applicant wishes to cover only some of the risks pertaining to that class. The competent authorities may restrict authorization requested for one of the classes to the operations set out in the scheme of operations referred to in Article 9. Each Member State may grant authorization for two or more of the classes, where its national laws permit such classes to be carried on simultaneously.' Article 5 Article 8 of Directive 79/267/EEC shall be replaced by the following: 'Article 8 1. The home Member State shall require every assurance undertaking for which authorization is sought to: (a) adopt one of the following forms: - in the case of the Kingdom of Belgium: "société anonyme/naamloze vennootschap", "société en commandite par actions/commanditaire vennootschap op aandelen", "association d'assurance mutuelle/onderlinge verzekeringsvereniging", "société coopérative/cooeperatieve vennootschap", - in the case of the Kingdom of Denmark: "aktieselskaber", "gensidige selskaber", "pensionskasser omfattet af lov om forsikringsvirksomhed (tvaergaaende pensionskasser)", - in the case of the Federal Republic of Germany: "Aktiengesellschaft", "Versicherungsverein auf Gegenseitigkeit", "oeffentlich-rechtliches Wettbewerbsversicherungsunternehmen", - in the case of the French Republic: "société anonyme", "société d'assurance mutuelle", "institution de prévoyance régie par le code de la sécurité sociale", "institution de prévoyance régie par le code rural" and "mutuelles régies par le code de la mutualité", - in the case of Ireland: incorporated companies limited by shares or by guarantee or unlimited, societies registered under the Industrial and Provident Societies Acts and societies registered under the Friendly Societies Acts, - in the case of the Italian Republic: "societá per azioni", "societá cooperativa", "mutua di assicurazione", - in the case of the Grand Duchy of Luxembourg: "société anonyme", "société en commandite par actions", "association d'assurances mutuelles", "société coopérative", - in the case of the Kingdom of the Netherlands: "naamloze vennootschap", "onderlinge waarborgmaatschappij", - in the case of the United Kingdom: incorporated companies limited by shares or by guarantee or unlimited, societies registered under the Industrial and Provident Societies Acts, societies registered or incorporated under the Friendly Societies Acts, the association of underwriters known as Lloyd's, - in the case of the Hellenic Republic: "áíþíõìç aaôáéñssá", - in the case of the Kingdom of Spain: "sociedad anonima", "sociedad mutua", "sociedad cooperativa", - in the case of the Portuguese Republic: "sociedade anónima", "mútua de seguros". An assurance undertaking may also adopt the form of a European company when that has been established. Furthermore, Member States may, where appropriate, set up undertakings in any public-law form provided that such bodies have as their object insurance operations under conditions equivalent to those under which private-law undertakings operate; (b) limit its objects to the business provided for in this Directive and operations directly arising therefrom, to the exclusion of all other commercial business; (c) submit a scheme of operations in accordance with Article 9; (d) possess the minimum guarantee fund provided for in Article 20 (2); (e) be effectively run by persons of good repute with appropriate professional qualifications or experience. 2. An undertaking seeking authorization to extend its business to other classes or to extend an authorization covering only some of the risks pertaining to one class shall be required to submit a scheme of operations in accordance with Article 9. It shall, furthermore, be required to show proof that it possesses the solvency margin provided for in Article 19 and the guarantee fund referred to in Article 20 (1) and (2). 3. Member States shall not adopt provisions requiring the prior approval or systematic notification of general and special policy conditions, of scales of premiums, of the technical bases, used in particular for calculating scales of premiums and technical provisions or of forms and other printed documents which an assurance undertaking intends to use in its dealings with policy-holders. Notwithstanding the first subparagraph, for the sole purpose of verifying compliance with national provisions concerning actuarial principles, the home Member State may require systematic notification of the technical bases used for calculating scales of premiums and technical provisions, without that requirement constituting a prior condition for an undertaking to carry on its business. Nothing in this Directive shall prevent Member States from maintaining in force or introducing laws, regulations or administrative provisions requiring approval of the memorandum and articles of association and the communication of any other documents necessary for the normal exercise of supervision. Not later than five years after the date of entry into force of Directive 92/96/EEC (*), the Commission shall submit a report to the Council on the implementation of this paragraph. 4. The abovementioned provisions may not require that any application for authorization be considered in the light of the economic requirements of the market. (*) OJ No L 360, 9. 12. 1992, p. 1. Article 6 Article 9 of Directive 79/267/EEC shall be replaced by the following: 'Article 9 The scheme of operations referred to in Article 8 (1) (c) and (2) shall include particulars or proof concerning: (a) the nature of the commitments which the undertaking proposes to cover; (b) the guiding principles as to reassurance; (c) the items constituting the minimum guarantee fund; (d) estimates relating to the costs of setting up the administrative services and the organization for securing business and the financial resources intended to meet those costs; in addition, for the first three financial years: (e) a plan setting out detailed estimates of income and expenditure in respect of direct business, reassurance acceptances and reassurance cessions; (f) a forecast balance sheet; (g) estimates relating to the financial resources intended to cover underwriting liabilities and the solvency margin.' Article 7 The competent authorities of the home Member State shall not grant an undertaking authorization to take up the business of assurance before they have been informed of the identities of the shareholders or members, direct or indirect, whether natural or legal persons, who have qualifying holdings in that undertaking and of the amounts of those holdings. The same authorities shall refuse authorization if, taking into account the need to ensure the sound and prudent management of an assurance undertaking, they are not satisfied as to the qualifications of the shareholders or members. TITLE III HARMONIZATION OF CONDITIONS GOVERNING PURSUIT OF BUSINESS Chapter 1 Article 8 Article 15 of Directive 79/267/EEC shall be replaced by the following: 'Article 15 1. The financial supervision of an assurance undertaking, including that of the business it carries on either through branches or under the freedom to provide services, shall be the sole responsibility of the home Member State. If the competent authorities of the Member State of the commitment have reason to consider that the activities of an assurance undertaking might affect its financial soundness, they shall inform the competent authorities of the undertaking's home Member State. The latter authorities shall determine whether the undertaking is complying with the prudential principles laid down in this Directive. 2. That financial supervision shall include verification, with respect to the assurance undertaking's entire business, of its state of solvency, the establishment of technical provisions, including mathematical provisions, and of the assets covering them, in accordance with the rules laid down or practices followed in the home Member State pursuant to the provisions adopted at Community level. 3. The competent authorities of the home Member State shall require every assurance undertaking to have sound administrative and accounting procedures and adequate internal control mechanisms.' Article 9 Article 16 of Directive 79/267/EEC shall be replaced by the following: 'Article 16 The Member State of the branch shall provide that, where an assurance undertaking authorized in another Member State carries on business through a branch, the competent authorities of the home Member State may, after having first informed the competent authorities of the Member State of the branch, carry out themselves, or through the intermediary of persons they appoint for that purpose, on-the-spot verification of the information necessary to ensure the financial supervision of the undertaking. The authorities of the Member State of the branch may participate in that verification'. Article 10 Article 23 (2) and (3) of Directive 79/267/EEC shall be replaced by the following: '2. Member States shall require assurance undertakings with head offices within their territories to render periodically the returns, together with statistical documents, which are necessary for the purposes of supervision. The competent authorities shall provide each other with any documents and information that are useful for the purposes of supervision. 3. Every Member State shall take all steps necessary to ensure that the competent authorities have the powers and means necessary for the supervision of the business of assurance undertakings with head offices within their territories, including business carried on outside those territories, in accordance with the Council directives governing those activities and for the purpose of seeing that they are implemented. These powers and means must, in particular, enable the competent authorities to: (a) make detailed enquiries regarding the undertaking's situation and the whole of its business, inter alia by: - gathering information or requiring the submission of documents concerning its assurance business, - carrying out on-the-spot investigations at the undertaking's premises; (b) take any measures, with regard to the undertaking, its directors or managers or the persons who control it, that are appropriate and necessary to ensure that the undertaking's business continues to comply with the laws, regulations and administrative provisions with which the undertaking must comply in each Member State and in particular with the scheme of operations in so far as it remains mandatory, and to prevent or remedy any irregularities prejudicial to the interests of the assured persons; (c) ensure that those measures are carried out, if need be by enforcement, where appropriate through judicial channels. Member States may also make provision for the competent authorities to obtain any information regarding contracts which are held by intermediaries.' Article 11 1. Article 6 (2) to (7) of Directive 90/619/EEC shall be deleted. 2. Under the conditions laid down by national law, each Member State shall authorize assurance undertakings with head offices within its territory to transfer all or part of their portfolios of contracts, concluded under either the right of establishment or the freedom to provide services, to an accepting office established within the Community, if the competent authorities of the home Member State of the accepting office certify that after taking the transfer into account the latter possesses the necessary solvency margin. 3. Where a branch proposes to transfer all or part of its portfolio of contracts, concluded under either the right of establishment or the freedom to provide services, the Member State of the branch shall be consulted. 4. In the circumstances referred to in paragraph 2 and 3, the authorities of the home Member State of the transferring undertaking shall authorize the transfer after obtaining the agreement of the competent authorities of the Member States of the commitment. 5. The competent authorities of the Member States consulted shall give their opinion or consent to the competent authorities of the home Member State of the transferring assurance undertaking within three months of receiving a request; the absence of any response within that period from the authorities consulted shall be considered equivalent to a favourable opinion or tacit consent. 6. A transfer authorized in accordance with this Article shall be published as laid down by national law in the Member State of the commitment. Such transfers shall automatically be valid against policy-holders, the assured persons and any other person having rights or obligations arising out of the contracts transferred. This provision shall not affect the Member States' rights to give policy-holders the option of cancelling contracts within a fixed period after a transfer. Article 12 1. Article 24 of Directive 79/267/EEC shall be replaced by the following: 'Article 24 1. If an undertaking does not comply with Article 17, the competent authority of its home Member State may prohibit the free disposal of its assets after having communicated its intention to the competent authorities of the Member States of commitment. 2. For the purposes of restoring the financial situation of an undertaking the solvency margin of which has fallen below the minimum required under Article 19, the competent authority of the home Member State shall require that a plan for the restoration of a sound financial position be submitted for its approval. In exceptional circumstances, if the competent authority is of the opinion that the financial situation of the undertaking will further deteriorate, it may also restrict or prohibit the free disposal of the undertaking's assets. It shall inform the authorities of other Member States within the territories of which the undertaking carries on business of any measures it has taken and the latter shall, at the request of the former, take the same measures. 3. If the solvency margin falls below the guarantee fund as defined in Article 20, the competent authority of the home Member State shall require the undertaking to submit a short-term finance scheme for its approval. It may also restrict or prohibit the free disposal of the undertaking's assets. It shall inform the authorities of other Member States within the territories of which the undertaking carries on business accordingly and the latter shall, at the request of the former, take the same measures. 4. The competent authorities may further take all measures necessary to safeguard the interests of the assured persons in the cases provided for in paragraphs 1, 2 and 3. 5. Each Member State shall take the measures necessary to be able in accordance with its national law to prohibit the free disposal of assets located within its territory at the request, in the cases provided for in paragraphs 1, 2 and 3, of the undertaking's home Member State, which shall designate the assets to be covered by such measures.' Article 13 Article 26 of Directive 79/267/EEC shall be replaced by the following: 'Article 26 1. Authorization granted to an assurance undertaking by the competent authority of its home Member State may be withdrawn by that authority if that undertaking: (a) does not make use of the authorization within 12 months, expressly renounces it or ceases to carry on business for more than six months, unless the Member State concerned has made provision for authorization to lapse in such cases; (b) no longer fulfils the conditions for admission; (c) has been unable, within the time allowed, to take the measures specified in the restoration plan or finance scheme referred to in Article 24; (d) fails seriously in its obligations under the regulations to which it is subject. In the event of the withdrawal or lapse of the authorization, the competent authority of the home Member State shall notify the competent authorities of the other Member States accordingly and they shall take appropriate measures to prevent the undertaking from commencing new operations within their territories, under either the freedom of establishment or the freedom to provide services. The home Member State's competent authority shall, in conjunction with those authorities, take all necessary measures to safeguard the interests of the assured persons and shall restrict, in particular, the free disposal of the assets of the undertaking in accordance with Article 24 (1), (2), second subparagraph, or (3), second subparagraph. 2. Any decision to withdraw an authorization shall be supported by precise reasons and notified to the undertaking in question.' Article 14 1. Member States shall require any natural or legal person who proposes to acquire, directly or indirectly, a qualifying holding in an assurance undertaking first to inform the competent authorities of the home Member State, indicating the size of the intended holding. Such a person must likewise inform the competent authorities of the home Member State if he proposes to increase his qualifying holding so that the proportion of the voting rights or of the capital held by him would reach or exceed 20, 33 or 50 % or so that the assurance undertaking would become his subsidiary. The competent authorities of the home Member State shall have a maximum of three months from the date of the notification provided for in the first subparagraph to oppose such a plan if, in view of the need to ensure sound and prudent management of the assurance undertaking, they are not satisfied as to the qualifications of the person referred to in the first subparagraph. If they do not oppose the plan in question they may fix a maximum period for its implementation. 2. Member States shall require any natural or legal person who proposes to dispose, directly or indirectly, of a qualifying holding in an assurance undertaking first to inform the competent authorities of the home Member State, indicating the size of his intended holding. Such a person must likewise inform the competent authorities if he proposes to reduce his qualifying holding so that the proportion of the voting rights or of the capital held by him would fall below 20, 33 or 50 % or so that the assurance undertaking would cease to be his subsidiary. 3. On becoming aware of them, assurance undertakings shall inform the competent authorities of their home Member States of any acquisitions or disposals of holdings in their capital that cause holdings to exceed or fall below one of the thresholds referred to in paragraphs 1 and 2. They shall also, at least once a year, inform them of the names of shareholders and members possessing qualifying holdings and the sizes of such holdings as shown, for example, by the information received at the annual general meetings of shareholders and members or as a result of compliance with the regulations relating to companies listed on stock exchanges. 4. Member States shall require that, if the influence exercised by the persons referred to in paragraph 1 is likely to operate to the detriment of the prudent and sound management of the assurance undertaking, the competent authorities of the home Member State shall take appropriate measures to put an end to that situation. Such measures may consist, for example, in injunctions, sanctions against directors and managers, or the suspension of the exercise of the voting rights attaching to the shares held by the shareholders or members in question. Similar measures shall apply to natural or legal persons failing to comply with the obligation to provide prior information, as laid down in paragraph 1. If a holding is acquired despite the opposition of the competent authorities, the Member States shall, regardless of any other sanctions to be adopted, provide either for exercise of the corresponding voting rights to be suspended, or for the nullity of votes cast or for the possibility of their annulment. Article 15 1. The Member States shall provide that all persons working or who have worked for the competent authorities, as well as auditors or experts acting on behalf of the competent authorities, shall be bound by the obligation of professional secrecy. This means that no confidential information which they may receive in the course of their duties may be divulged to any person or authority whatsoever, except in summary or aggregate form, such that individual assurance undertakings cannot be identified, without prejudice to cases covered by criminal law. Nevertheless, where an assurance undertaking has been declared bankrupt or is being compulsorily wound up, confidential information which does not concern third parties involved in attempts to rescue that undertaking may be divulged in civil or commercial proceedings. 2. Paragraph 1 shall not prevent the competent authorities of the different Member States from exchanging information in accordance with the directives applicable to assurance undertakings. That information shall be subject to the conditions of professional secrecy indicated in paragraph 1. 3. Member States may conclude cooperation agreements, providing for exchanges of information, with the competent authorities of third countries only if the information disclosed is subject to guarantees of professional secrecy at least equivalent to those referred to in this Article. 4. Competent authorities receiving confidential information under paragraphs 1 or 2 may use it only in the course of their duties: - to check that the conditions governing the taking-up of the business of assurance are met and to facilitate monitoring of the conduct of such business, especially with regard to the monitoring of technical provisions, solvency margins, administrative and accounting procedures and internal control mechanisms, or - to impose sanctions, or - in administrative appeals against decisions of the competent authority, or - in court proceedings initiated pursuant to Article 50 or under special provisions provided for in the directives adopted in the field of assurance undertakings. 5. Paragraphs 1 and 4 shall not preclude the exchange of information within a Member State, where there are two or more competent authorities in the same Member State, or, between Member States, between competent authorities and: - authorities responsible for the official supervision of credit institutions and other financial organizations and the authorities responsible for the supervision of financial markets, - bodies involved in the liquidation and bankruptcy of assurance undertakings and in other similar procedures, and - persons responsible for carrying out statutory audits of the accounts of assurance undertakings and other financial institutions, in the discharge of their supervisory functions, and the disclosure, to bodies which administer (compulsory) winding-up proceedings or guarantee funds, of information necessary to the performance of their duties. The information received by these authorities, bodies and persons shall be subject to the obligation of professional secrecy laid down in paragraph 1. 6. In addition, notwithstanding paragraphs 1 and 4, Member States may, under provisions laid down by law, authorize the disclosure of certain information to other departments of their central government administrations responsible for legislation on the supervision of credit institutions, financial institutions, investment services and assurance undertakings and to inspectors acting on behalf of those departments. However, such disclosures may be made only where necessary for reasons of prudential control. However, Member States shall provide that information received under paragraphs 2 and 5 and that obtained by means of the on-the-spot verification referred to in Article 16 of Directive 79/267/EEC may never be disclosed in the cases referred to in this paragraph except with the express consent of the competent authorities which disclosed the information or of the competent authorities of the Member State in which on-the-spot verification was carried out. Article 16 Article 13 of Directive 79/267/EEC shall be replaced by the following: 'Article 13 1. Without prejudice to paragraphs 3 and 7, no undertaking may be authorized both pursuant to this Directive and pursuant to Directive 73/239/EEC. 2. However, Member States may provide that: - undertakings authorized pursuant to this Directive may also obtain authorization, in accordance with Article 6 of Directive 73/239/EEC for the risks listed in classes 1 and 2 in the Annex to that Directive, - undertakings authorized pursuant to Article 6 of Directive 73/239/EEC solely for the risks listed in classes 1 and 2 in the Annex to that Directive may obtain authorization pursuant to this Directive. 3. Subject to paragraph 6, undertakings referred to in paragraph 2 and those which at the time of notification of this Directive carry on simultaneously both of the activities covered by this Directive and by Directive 73/239/EEC may continue to do so, provided that each activity is separately managed in accordance with Article 14. 4. Member States may provide that the undertakings referred to in paragraph 2 shall comply with the accounting rules governing undertakings authorized pursuant to this Directive for all of their activities. Pending coordination in this respect, Member States may also provide that, with regard to rules on winding-up, activities relating to the risks listed in classes 1 and 2 in the Annex to Directive 73/239/EEC carried on by the undertakings referred to in paragraph 2 shall be governed by the rules applicable to life assurance activities. 5. Where an undertaking carrying on the activities referred to in the Annex to Directive 73/239/EEC has financial, commercial or administrative links with an undertaking carrying on the activities covered by this Directive, the supervisory authorities of the Member States within whose territories the head offices of those undertakings are situated shall ensure that the accounts of the undertakings in question are not distorted by agreements between these undertakings or by any arrangement which could affect the apportionment of expenses and income. 6. Any Member State may require undertakings whose head offices are situated in its territory to cease, within a period to be determined by the Member State concerned, the simultaneous pursuit of activities in which they were engaged at the time of notification of this Directive. 7. The provisions of this Article shall be reviewed on the basis of a report from the Commission to the Council in the light of future harmonization of the rules on winding-up, and in any case before 31 December 1999.' Article 17 Article 35 of Directive 79/267/EEC and Article 18 of Directive 90/619/EEC shall be deleted. Chapter 2 Article 18 Article 17 of Directive 79/267/EEC shall be replaced by the following: 'Article 17 1. The home Member State shall require every assurance undertaking to establish sufficient technical provisions, including mathematical provisions, in respect of its entire business. The amount of such technical provisions shall be determined according to the following principles: A. (i) The amount of the technical life-assurance provisions shall be calculated by a sufficiently prudent prospective actuarial valuation, taking account of all future liabilities as determined by the policy conditions for each existing contract, including: - all guaranteed benefits, including guaranteed surrender values, - bonuses to which policy-holders are already either collectively or individually entitled, however those bonuses are described - vested, declared or allotted, - all options available to the policy-holder under the terms of the contract, - expenses, including commissions; taking credit for future premiums due; (ii) the use of a retrospective method is allowed, if it can be shown that the resulting technical provisions are not lower than would be required under a sufficiently prudent prospective calculation or if a prospective method cannot be used for the type of contract involved; (iii) a prudent valuation is not a "best estimate" valuation, but shall include an appropriate margin for adverse deviation of the relevant factors; (iv) the method of valuation for the technical provisions must not only be prudent in itself, but must also be so having regard to the method of valuation for the assets covering those provisions; (v) technical provisions shall be calculated separately for each contract. The use of appropriate approximations or generalizations is allowed, however, where they are likely to give approximately the same result as individual calculations. The principle of separate calculation shall in no way prevent the establishment of additional provisions for general risks which are not individualized; (vi) where the surrender value of a contract is guaranteed, the amount of the mathematical provisions for the contract at any time shall be at least as great as the value guaranteed at that time. B. The rate of interest used shall be chosen prudently. It shall be determined in accordance with the rules of the competent authority in the home Member State, applying the following principles: (a) for all contracts, the competent authority of the undertaking's home Member State shall fix one or more maximum rates of interest, in particular in accordance with the following rules: (i) when contracts contain an interest rate guarantee, the competent authority in the home Member State shall set a single maximum rate of interest. It may differ according to the currency in which the contract is denominated, provided that it is not more than 60 % of the rate on bond issues by the State in whose currency the contract is denominated. In the case of a contract denominated in ecus, this limit shall be set by reference to ecu-denominated issues by the Community institutions. If a Member State decides, pursuant to the second sentence of the preceding paragraph, to set a maximum rate of interest for contracts denominated in another Member State's currency, it shall first consult the competent authority of the Member State in whose currency the contract is denominated; (ii) however, when the assets of the undertaking are not valued at their purchase price, a Member State may stipulate that one or more maximum rates may be calculated taking into account the yield on the corresponding assets currently held, minus a prudential margin and, in particular for contracts with periodic premiums, furthermore taking into account the anticipated yield on future assets. The prudential margin and the maximum rate or rates of interest applied to the anticipated yield on future assets shall be fixed by the competent authority of the home Member State; (b) the establishment of a maximum rate of interest shall not imply that the undertaking is bound to use a rate as high as that; (c) the home Member State may decide not to apply (a) to the following categories of contracts: - unit-linked contracts, - single-premium contracts for a period of up to eight years, - without-profits contracts, and annuity contracts with no surrender value. In the cases referred to in the last two indents of the first subparagraph, in choosing a prudent rate of interest, account may be taken of the currency in which the contract is denominated and corresponding assets currently held and where the undertaking's assets are valued at their current value, the anticipated yield on future assets. Under no circumstances may the rate of interest used be higher than the yield on assets as calculated in accordance with the accounting rules in the home Member State, less an appropriate deduction; (d) the Member State shall require an undertaking to set aside in its accounts a provision to meet interest-rate commitments vis-à-vis policy-holders if the present or foreseeable yield on the undertaking's assets is insufficient to cover those commitments; (e) the Commission and the competent authorities of the Member States which so request shall be notified of the maximum rates of interest set under (a). C. The statistical elements of the valuation and the allowance for expenses used shall be chosen prudently, having regard to the State of the commitment, the type of policy and the administrative costs and commissions expected to be incurred. D. In the case of participating contracts, the method of calculation for technical provisions may take into account, either implicitly or explicitly, future bonuses of all kinds, in a manner consistent with the other assumptions on future experience and with the current method of distribution of bonuses. E. Allowance for future expenses may be made implicitly, for instance by the use of future premiums net of management charges. However, the overall allowance, implicit or explicit, shall be not less than a prudent estimate of the relevant future expenses. F. The method of calculation of technical provisions shall not be subject to discontinuities from year to year arising from arbitrary changes to the method or the bases of calculation and shall be such as to recognize the distribution of profits in an appropriate way over the duration of each policy. 2. Assurance undertakings shall make available to the public the bases and methods used in the calculation of the technical provisions, including provisions for bonuses. 3. The home Member State shall require every assurance undertaking to cover the technical provisions in respect of its entire business by matching assets, in accordance with Article 24 of Directive 92/96/EEC. In respect of business written in the Community, these assets must be localized within the Community. Member States shall not require assurance undertakings to localize their assets in a particular Member State. The home Member State may, however, permit relaxations in the rules on the localization of assets. 4. If the home Member State allows any technical provisions to be covered by claims against reassurers, it shall fix the percentage so allowed. In such case, it may not require the localization of the assets representing such claims.' Article 19 Premiums for new business shall be sufficient, on reasonable actuarial assumptions, to enable assurance undertakings to meet all their commitments and, in particular, to establish adequate technical provisions. For this purpose, all aspects of the financial situation of an assurance undertaking may be taken into account, without the input from resources other than premiums and income earned thereon being systematic and permanent in such a way that it may jeopardize the undertaking's solvency in the long term. Article 20 The assets covering the technical provisions shall take account of the type of business carried on by an undertaking in such a way as to secure the safety, yield and marketability of its investments, which the undertaking shall ensure are diversified and adequately spread. Article 21 1. The home Member State may not authorize assurance undertakings to cover their technical provisions with any but the following categories of assets: A. Investments (a) debt securities, bonds and other money- and capital-market instruments; (b) loans; (c) shares and other variable-yield participations; (d) units in undertakings for collective investment in transferable securities and other investment funds; (e) land, buildings and immovable property rights; B. Debts and claims (f) debts owed by reassurers, including reassurers' shares of technical provisions; (g) deposits with and debts owed by ceding undertakings; (h) debts owed by policy-holders and intermediaries arising out of direct and reassurance operations; (i) advances against policies; (j) tax recoveries; (k) claims against guarantee funds; C. Others (l) tangible fixed assets, other than land and buildings, valued on the basis of prudent amortization; (m) cash at bank and in hand, deposits with credit institutions and any other body authorized to receive deposits; (n) deferred acquisition costs; (o) accrued interest and rent, other accrued income and prepayments; (p) reversionary interests. In the case of the association of underwriters known as Lloyd's, asset categories shall also include guarantees and letters of credit issued by credit institutions within the meaning of Directive 77/780/EEC (¹) or by assurance undertakings, together with verifiable sums arising out of life assurance policies, to the extent that they represent funds belonging to members. (¹) First Council Directive 77/780/EEC of 12 December 1977 on the coordination of the laws, regulations and administrative provisions relating to the taking up and pursuit of the business of credit institutions (OJ No L 322, 17. 12. 1977, p. 30). Directive as last amended by Directive 89/646/EEC (OJ No L 386, 30. 12. 1989, p. 1). The inclusion of any asset or category of assets listed in the first subparagraph shall not mean that all these assets should automatically be accepted as cover for technical provisions. The home Member State shall lay down more detailed rules fixing the conditions for the use of acceptable assets; in this connection, it may require valuable security or guarantees, particularly in the case of debts owed by reassurers. In determining and applying the rules which it lays down, the home Member State shall, in particular, ensure that the following principles are complied with: (i) assets covering technical provisions shall be valued net of any debts arising out of their acquisition; (ii) all assets must be valued on a prudent basis, allowing for the risk of any amounts not being realizable. In particular, tangible fixed assets other than land and buildings may be accepted as cover for technical provisions only if they are valued on the basis of prudent amortization; (iii) loans, whether to undertakings, to a State or international organization, to local or regional authorities or to natural persons, may be accepted as cover for technical provisions only if there are sufficient guarantees as to their security, whether these are based on the status of the borrower, mortgages, bank guarantees or guarantees granted by assurance undertakings or other forms of security; (iv) derivative instruments such as options, futures and swaps in connection with assets covering technical provisions may be used in so far as they contribute to a reduction of investment risks or facilitate efficient portfolio management. They must be valued on a prudent basis and may be taken into account in the valuation of the underlying assets; (v) transferrable securities which are not dealt in on a regulated market may be accepted as cover for technical provisions only if they can be realized in the short term or if they are holdings in credits institutions, in assurance undertakings, within the limits permitted by Article 8 of Directive 79/267/EEC, or in investment undertakings established in a Member State; (vi) debts owed by and claims against a third party may be accepted as cover for the technical provisions only after deduction of all amounts owed to the same third party; (vii) the value of any debts and claims accepted as cover for technical provisions must be calculated on a prudent basis, with due allowance for the risk of any amounts not being realizable. In particular, debts owed by policy-holders and intermediaries arising out of assurance and reassurance operations may be accepted only in so far as they have been outstanding for not more than three months; (viii) where the assets held include an investment in a subsidiary undertaking which manages all or part of the assurance undertaking's investments on its behalf, the home Member State must, when applying the rules and principles laid down in this Article, take into account the underlying assets held by the subsidiary undertaking; the home Member State may treat the assets of other subsidiaries in the same way; (ix) deferred acquisition costs may be accepted as cover for technical provisions only to the extent that this is consistent with the calculation of the mathematical provisions. 2. Notwithstanding paragraph 1, in exceptional circumstances and at an assurance undertaking's request, the home Member State may, temporarily and under a properly reasoned decision, accept other categories of assets as cover for technical provisions, subject to Article 20. Article 22 1. As regards the assets covering technical provisions, the home Member State shall require every assurance undertaking to invest no more than: (a) 10 % of its total gross technical provisions in any one piece of land or building, or a number of pieces of land or buildings close enough to each other to be considered effectively as one investment; (b) 5 % of its total gross technical provisions in shares and other negotiable securities treated as shares, bonds, debt securities and other money- and capital-market instruments from the same undertaking, or in loans granted to the same borrower, taken together, the loans being loans other than those granted to a State, regional or local authority or to an international organization of which one or more Member States are members. This limit may be raised to 10 % if an undertaking invests not more than 40 % of its gross technical provisions in the loans or securities of issuing bodies and borrowers in each of which it invests more than 5 % of its assets; (c) 5 % of its total gross technical provisions in unsecured loans, including 1 % for any single unsecured loan, other than loans granted to credit institutions, assurance undertakings - in so far as Article 8 of Directive 79/267/EEC allows it - and investment undertakings established in a Member State. The limits may be raised to 8 and 2 % respectively by a decision taken on a case-by-case basis by the competent authority of the home Member State; (d) 3 % of its total gross technical provisions in the form of cash in hand; (e) 10 % of its total gross technical provisions in shares, other securities treated as shares and debt securities which are not dealt in on a regulated market. 2. The absence of a limit in paragraph 1 on investment in any particular category does not imply that assets in that category should be accepted as cover for technical provisions without limit. The home Member State shall lay down more detailed rules fixing the conditions for the use of acceptable assets. In particular it shall ensure, in the determination and the application of those rules, that the following principles are complied with: (i) assets covering technical provisions must be diversified and spread in such a way as to ensure that there is no excessive reliance on any particular category of asset, investment market or investment; (ii) investment in particular types of asset which show high levels of risk, whether because of the nature of the asset or the quality of the issuer, must be restricted to prudent levels; (iii) limitations on particular categories of asset must take account of the treatment of reassurance in the calculation of technical provisions; (iv) where the assets held include an investment in a subsidiary undertaking which manages all or part of the assurance undertaking's investments on its behalf, the home Member State must, when applying the rules and principles laid down in this Article, take into account the underlying assets held by the subsidiary undertaking; the home Member State may treat the assets of other subsidiaries in the same way; (v) the percentage of assets covering technical provisions which are the subject of non-liquid investments must be kept to a prudent level; (vi) where the assets held include loans to or debt securities issued by certain credit institutions, the home Member State may, when applying the rules and principles contained in this Article, take into account the underlying assets held by such credit institutions. This treatment may be applied only where the credit institution has its head office in a Member State, is entirely owned by that Member State and/or that State's local authorities and its business, according to its memorandum and articles of association, consists of extending, through its intermediaries, loans to, or guaranteed by, States or local authorities or of loans to bodies closely linked to the State or to local authorities. 3. In the context of the detailed rules laying down the conditions for the use of acceptable assets, the Member State shall give more limitative treatment to: - any loan unaccompanied by a bank guarantee, a guarantee issued by an assurance undertaking, a mortgage or any other form of security, as compared with loans accompanied by such collateral, - UCITS not coordinated within the meaning of Directive 85/611/EEC (¹) and other investment funds, as compared with UCITS coordinated within the meaning of that Directive, - securities which are not dealt in on a regulated market, as compared with those which are, - bonds, debt securities and other money- and capital-market instruments not issued by States, local or regional authorities or undertakings belonging to Zone A as defined in Directive 89/647/EEC (²), or the issuers of which are international organizations not numbering at least one Community Member State among their members, as compared with the same financial instruments issued by such bodies. 4. Member States may raise the limit laid down in paragraph 1 (b) to 40 % in the case of certain debt (¹) Council Directive 85/611/EEC of 20 December 1985 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (OJ No L 375, 31. 12. 1985, p. 3). Directive as amended by Directive 88/220/EEC (OJ No L 100, 19. 4. 1988, p. 31). (²) Council Directive 89/647/EEC of 18 December 1989 on a solvency ratio for credit institutions (OJ No L 386, 30. 12. 1989, p. 14). securities when these are issued by a credit institution which has its head office in a Member State and is subject by law to special official supervision designed to protect the holders of those debt securities. In particular, sums deriving from the issue of such debt securities must be invested in accordance with the law in assets which, during the whole period of validity of the debt securities, are capable of covering claims attaching to debt securities and which, in the event of failure of the issuer, would be used on a priority basis for the reimbursement of the principal and payment of the accrued interest. 5. Member States shall not require assurance undertakings to invest in particular categories of assets. 6. Notwithstanding paragraph 1, in exceptional circumstances and at the assurance undertaking's request, the home Member State may, temporarily and under a properly reasoned decision, allow exceptions to the rules laid down in paragraph 1 (a) to (e), subject to Article 20. Article 23 1. Where the benefits provided by a contract are directly linked to the value of units in an UCITS or to the value of assets contained in an internal fund held by the insurance undertaking, usually divided into units, the technical provisions in respect of those benefits must be represented as closely as possible by those units or, in the case where units are not established, by those assets. 2. Where the benefits provided by a contract are directly linked to a share index or some other reference value other than those referred to in paragraph 1, the technical provisions in respect of those benefits must be represented as closely as possible either by the units deemed to represent the reference value or, in the case where units are not established, by assets of appropriate security and marketability which correspond as closely as possible with those on which the particular reference value is based. 3. Articles 20 and 22 shall not apply to assets held to match liabilities which are directly linked to the benefits referred to in paragraphs 1 and 2. References to the technical provisions in Article 22 shall be to the technical provisions excluding those in respect of such liabilities. 4. Where the benefits referred to in paragraph 1 and 2 include a guarantee of investment performance or some other guaranteed benefit, the corresponding additional technical provisions shall be subject to Articles 20, 21 and 22. Article 24 1. For the purposes of Articles 17 (3) and 28 of Directive 79/267/EEC, Member States shall comply with Annex I to this Directive as regards the matching rules. 2. This Article shall not apply to the commitments referred to in Article 23 of this Directive. Article 25 Article 18, second subparagraph, point 1 of Directive 79/267/EEC shall be replaced by the following: '1. the assets of the undertaking free of any foreseeable liabilities, less any intangible items. In particular the following shall be included: - the paid-up share capital or, in the case of a mutual assurance undertaking, the effective initial fund plus any members' accounts which meet all the following criteria: (a) the memorandum and articles of association must stipulate that payments may be made from these accounts to members only in so far as this does not cause the solvency margin to fall below the required level, or, after the dissolution of the undertaking, if all the undertaking's other debts have been settled; (b) the memorandum and articles of association must stipulate, with respect to any such payments for reasons other than the individual termination of membership, that the competent authorities must be notified at least one month in advance and can prohibit the payment within that period; (c) the relevant provisions of the memorandum and articles of association may be amended only after the competent authorities have declared that they have no objection to the amendment, without prejudice to the criteria stated in (a) and (b), - one half of the unpaid share capital or initial fund, once the paid-up part amounts to 25 % of that share capital or fund, - reserves (statutory reserves and free reserves) not corresponding to underwriting liabilities, - any profits brought forward, - cumulative preferential share capital and subordinated loan capital may be included but, if so, only up to 50 % of the margin, no more than 25 % of which shall consist of subordinated loans with a fixed maturity, or fixed-term cumulative preferential share capital, if the following minimum criteria are met: (a) in the event of the bankruptcy or liquidation of the assurance undertaking, binding agreements must exist under which the subordinated loan capital or preferential share capital ranks after the claims of all other creditors and is not to be repaid until all other debts outstanding at the time have been settled. Subordinated loan capital must also fulfil the following conditions: (b) only fully paid-up funds may be taken into account; (c) for loans with a fixed maturity, the original maturity must be at least five years. No later than one year before the repayment date the assurance undertaking must submit to the competent authorities for their approval a plan showing how the solvency margin will be kept at or brought to the required level at maturity, unless the extent to which the loan may rank as a component of the solvency margin is gradually reduced during at least the last five years before the repayment date. The competent authorities may authorize the early repayment of such loans provided application is made by the issuing assurance undertaking and its solvency margin will not fall below the required level; (d) loans the maturity of which is not fixed must be repayable only subject to five years' notice unless the loans are no longer considered as a component of the solvency margin or unless the prior consent of the competent authorities is specifically required for early repayment. In the latter event the assurance undertaking must notify the competent authorities at least six months before the date of the proposed repayment, specifying the actual and required solvency margin both before and after that repayment. The competent authorities shall authorize repayment only if the assurance undertaking's solvency margin will not fall below the required level; (e) the loan agreement must not include any clause providing that in specified circumstances, other than the winding-up of the assurance undertaking, the debt will become repayable before the agreed repayment dates; (f) the loan agreement may be amended only after the competent authorities have declared that they have no objection to the amendment, - securities with no specified maturity date and other instruments that fulfil the following conditions, including cumulative preferential shares other than those mentioned in the preceding indent, up to 50 % of the margin for the total of such securities and the subordinated loan capital referred to in the preceding indent: (a) they may not be repaid on the initiative of the bearer or without the prior consent of the competent authority; (b) the contract of issue must enable the assurance undertaking to defer the payment of interest on the loan; (c) the lender's claims on the assurance undertaking must rank entirely after those of all non-subordinated creditors; (d) the documents governing the issue of the securities must provide for the loss-absorption capacity of the debt and unpaid interest, while enabling the assurance undertaking to continue its business; (e) only fully paid-up amounts may be taken into account.' Article 26 No more than three years after the date of application of this Directive, the Commission shall submit a report to the Insurance Committee on the need for further harmonization of the solvency margin. Article 27 Article 21 of Directive 79/267/EEC shall be replaced by the following: 'Article 21 1. Member States shall not prescribe any rules as to the choice of the assets that need not be used as cover for the technical provisions referred to in Article 17. 2. Subject to Article 17 (3), Article 24 (1), (2), (3) and (5) and the second subparagraph of Article 26 (1), Member States shall not restrain the free disposal of those assets, whether movable or immovable, that form part of the assets of authorized assurance undertakings. 3. Paragraphs 1 and 2 shall not preclude any measures which Member States, while safeguarding the interests of the lives assured, are entitled to take as owners or members of or partners in the undertakings in question.' Chapter 3 Article 28 The Member State of the commitment shall not prevent a policy-holder from concluding a contract with an assurance undertaking authorized under the conditions of Article 6 of Directive 79/267/EEC, as long as that does not conflict with legal provisions protecting the general good in the Member State of the commitment. Article 29 Member States shall not adopt provisions requiring the prior approval or systematic notification of general and special policy conditions, scales of premiums, technical bases used in particular for calculating scales of premiums and technical provisions or forms and other printed documents which an assurance undertaking intends to use in its dealings with policy-holders. Notwithstanding the first subparagraph, for the sole purpose of verifying compliance with national provisions concerning actuarial principles, the Member State of origin may require systematic communication of the technical Bases used in particular for calculating scales of premiums and technical provisions, without that requirement constituting a prior condition for an undertaking to carry on its business. Not later than five years after the date of application of this Directive, the Commission shall submit a report to the Council on the implementation of those provisions. Article 30 1. In the first subparagraph of Article 15 (1) of Directive 90/619/EEC the words 'in one of the cases referred to in Title III' shall be deleted. 2. Article 15 (2) of Directive 90/619/EEC shall be replaced by the following: '2. The Member States need not apply paragraph 1 to contracts of six months' duration or less, nor where, because of the status of the policy-holder or the circumstances in which the contract is concluded, the policy-holder does not need this special protection. Member States shall specify in their rules where paragraph 1 is not applied.' Article 31 1. Before the assurance contract is concluded, at least the information listed in point A of Annex II shall be communicated to the policy-holder. 2. The policy-holder shall be kept informed throughout the term of the contract of any change concerning the information listed in point B of Annex II. 3. The Member State of the commitment may require assurance undertakings to furnish information in addition to that listed in Annex II only if it is necessary for a proper understanding by the policy-holder of the essential elements of the commitment. 4. The detailed rules for implementing this Article and Annex II shall be laid down by the Member State of the commitment. TITLE IV PROVISIONS RELATING TO RIGHT OF ESTABLISHMENT AND FREEDOM TO PROVIDE SERVICES Article 32 Article 10 of Directive 79/267/EEC shall be replaced by the following: 'Article 10 1. An assurance undertaking that proposes to establish a branch within the territory of another Member State shall notify the competent authorities of its home Member State. 2. The Member States shall require every assurance undertaking that proposes to establish a branch within the territory of another Member State to provide the following information when effecting the notification provided for in paragraph 1: (a) the Member State within the territory of which it proposes to establish a branch; (b) a scheme of operations setting out inter alia the types of business envisaged and the structural organization of the branch; (c) the address in the Member State of the branch from which documents may be obtained and to which they may be delivered, it being understood that that address shall be the one to which all communications to the authorized agent are sent; (d) the name of the branch's authorized agent, who must possess sufficient powers to bind the undertaking in relation to third parties and to represent it in relations with the authorities and courts of the Member State of the branch. With regard to Lloyd's, in the event of any litigation in the Member State of the branch arising out of underwritten commitments, the assured persons must not be treated less favourably than if the litigation had been brought against businesses of a conventional type. The authorized agent must, therefore, possess sufficient powers for proceedings to be taken against him and must in that capacity be able to bind the Lloyd's underwriters concerned. 3. Unless the competent authorities of the home Member State have reason to doubt the adequacy of the administrative structure or the financial situation of the assurance undertaking or the good repute and professional qualification or experience of the directors or managers or the authorized agent, taking into account the business planned, they shall within three months of receiving all the information referred to in paragraph 2 communicate that information to the competent authorities of the Member State of the branch and shall inform the undertaking concerned accordingly. The competent authorities of the home Member State shall also attest that the assurance undertaking has the minimum solvency margin calculated in accordance with Articles 19 and 20. Where the competent authorities of the home Member State refuse to communicate the information referred to in paragraph 2 to the competent authorities of the Member State of the branch they shall give the reasons for their refusal to the undertaking concerned within three months of receiving all the information in question. That refusal or failure to act shall be subject to a right to apply to the courts in the home Member State. 4. Before the branch of an assurance undertaking starts business, the competent authorities of the Member State of the branch shall, within two months of receiving the information referred to in paragraph 3, inform the competent authority of the home Member State, if appropriate, of the conditions under which, in the interest of the general good, that business must be carried on in the Member State of the branch. 5. On receiving a communication from the competent authorities of the Member State of the branch or, if no communication is received from them, on expiry of the period provided for in paragraph 4, the branch may be established and start business. 6. In the event of a change in any of the particulars communicated under paragraph 2 (b), (c) or (d), an assurance undertaking shall give written notice of the change to the competent authorities of the home Member State and of the Member State of the branch at least one month before making the change so that the competent authorities of the home Member State and the competent authorities of the Member State of the branch may fulfil their respective roles under paragraphs 3 and 4.' Article 33 Article 11 of Directive 79/267/EEC shall be deleted. Article 34 Article 11 of Directive 90/619/EEC shall be replaced by the following: 'Article 11 Any undertaking that intends to carry on business for the first time in one or more Member States under the freedom to provide services shall first inform the competent authorities of the home Member State, indicating the nature of the commitments it proposes to cover.' Article 35 Article 14 of Directive 90/619/EEC shall be replaced by the following: 'Article 14 1. Within one month of the notification provided for in Article 11, the competent authorities of the home Member State shall communicate to the Member State or Member States within the territory of which the undertaking intends to carry on business by way of the freedom to provide services: (a) a certificate attesting that the undertaking has the minimum solvency margin calculated in accordance with Articles 19 and 20 of Directive 79/267/EEC; (b) the classes which the undertaking has been authorized to offer; (c) the nature of the commitments which the undertaking proposes to cover in the Member State of the provision of services. At the same time, they shall inform the undertaking concerned accordingly. 2. Where the competent authorities of the home Member State do not communicate the information referred to in paragraph 1 within the period laid down, they shall give the reasons for their refusal to the undertaking within that same period. The refusal shall be subject to a right to apply to the courts in the home Member State. 3. The undertaking may start business on the certified date on which it is informed of the communication provided for in the first subparagraph of paragraph 1.' Article 36 Article 17 of Directive 90/619/EEC shall be replaced by the following: 'Article 17 Any change which an undertaking intends to make to the information referred to in Article 11 shall be subject to the procedure provided for in Articles 11 and 14.' Article 37 Articles 10, 12, 13, 16, 22 and 24 of Directive 90/619/EEC shall be deleted. Article 38 The competent authorities of the Member State of the branch or the Member State of the provision of services may require that the information which they are authorized under this Directive to request with regard to the business of assurance undertakings operating in the territory of that State shall be supplied to them in the official language or languages of that State. Article 39 1. Article 19 of Directive 90/619/EEC shall be deleted. 2. The Member State of the branch or of provision of services shall not lay down provisions requiring the prior approval or systematic notification of general and special policy conditions, scales of premiums, technical bases used in particular for calculating scales of premiums and technical provisions, forms and other printed documents which an undertaking intends to use in its dealings with policy-holders. For the purpose of verifying compliance with national provisions concerning assurance contracts, it may require an undertaking that proposes to carry on assurance business within its territory, under the right of establishment or the freedom to provide services, to effect only non-systematic notification of those policy conditions and other printed documents without that requirement constituting a prior condition for an undertaking to carry on its business. Article 40 1. Article 20 of Directive 90/619/EEC shall be deleted. 2. Any undertaking carrying on business under the right of establishment or the freedom to provide services shall submit to the competent authorities of the Member State of the branch and/or of the Member State of the provision of services all documents requested of it for the purposes of this Article in so far as undertakings the head office of which is in those Member States are also obliged to do so. 3. If the competent authorities of a Member State establish that an undertaking with a branch or carrying on business under the freedom to provide services in its territory is not complying with the legal provisions applicable to it in that State, they shall require the undertaking concerned to remedy that irregular situation. 4. If the undertaking in question fails to take the necessary action, the competent authorities of the Member State concerned shall inform the competent authorities of the home Member State accordingly. The latter authorities shall, at the earliest opportunity, take all appropriate measures to ensure that the undertaking concerned remedies that irregular situation. The nature of those measures shall be communicated to the competent authorities of the Member State concerned. 5. If, despite the measures taken by the home Member State or because those measures prove inadequate or are lacking in that State, the undertaking persists in violating the legal provisions in force in the Member State concerned, the latter may, after informing the competent authorities of the home Member State, take appropriate measures to prevent or penalize further irregularities, including, in so far as is strictly necessary, preventing that undertaking from continuing to conclude new assurance contracts within its territory. Member States shall ensure that in their territories it is possible to serve the legal documents necessary for such measures on assurance undertakings. 6. Paragraphs 3, 4 and 5 shall not affect the emergency power of the Member States concerned to take appropriate measures to prevent or penalize irregularities committed within their territories. This shall include the possibility of preventing assurance undertakings from continuing to conclude new assurance contracts within their territories. 7. Paragraph 3, 4 and 5 shall not affect the power of the Member States to penalize infringements within their territories. 8. If an undertaking which has committed an infringement has an establishment or possesses property in the Member State concerned, the competent authorities of the latter may, in accordance with national law, apply the administrative penalties prescribed for that infringement by way of enforcement against that establishment or property. 9. Any measure adopted under paragraphs 4 to 8 involving penalties or restrictions on the conduct of assurance business must be properly reasoned and communicated to the undertaking concerned. 10. Every two years, the Commission shall submit to the Insurance Committee a report summarizing the number and type of cases in which, in each Member State, authorization has been refused pursuant to Article 10 of Directive 79/267/EEC or Article 14 of Directive 90/619/EEC as amended by this Directive or measures have been taken under paragraph 5. Member States shall cooperate with the Commission by providing it with the information required for that report. Article 41 Nothing in this Directive shall prevent assurance undertakings with head offices in other Member States from advertising their services through all available means of communication in the Member State of the branch or Member State of the provision of services, subject to any rules governing the form and content of such advertising adopted in the interest of the general good. Article 42 1. Article 21 of Directive 90/619/EEC shall be deleted. 2. Should an assurance undertaking be wound up, commitments arising out of contracts underwritten through a branch or under the freedom to provide services shall be met in the same way as those arising out of that undertaking's other assurance contracts, without distinction as to nationality as far as the lives assured and the beneficiaries are concerned. Article 43 1. Article 23 of Directive 90/619/EEC shall be deleted. 2. Every assurance undertaking shall inform the competent authority of its home Member State, separately in respect of transactions carried out under the right of establishment and those carried out under the freedom to provide services, of the amount of the premiums, without deduction of reassurance, by Member State and by each of classes I to IX, as defined in the Annex to Directive 79/267/EEC. The competent authority of the home Member State shall, within a reasonable time and on an aggregate basis forward this information to the competent authorities of each of the Member States concerned which so request. Article 44 1. Article 25 of Directive 90/619/EEC shall be deleted. 2. Without prejudice to any subsequent harmonization, every assurance contract shall be subject exclusively to the indirect taxes and parafiscal charges on assurance premiums in the Member State of the commitment within the meaning of Article 2 (e) of Directive 90/619/EEC and also, with regard to Spain, to the surcharges legally established in favour of the Spanish 'Consorcio de compensación de seguros' for the performance of its functions relating to the compensation of losses arising from extraordinary events occurring in that Member State. The law applicable to the contract pursuant to Article 4 of Directive 90/619/EEC shall not affect the fiscal arrangements applicable. Pending future harmonization, each Member State shall apply to those undertakings which cover commitments situated within its territory its own national provisions for measures to ensure the collection of indirect taxes and parafiscal charges due under the first subparagraph. TITLE V TRANSITIONAL PROVISIONS Article 45 Member States may allow assurance undertakings with head offices in their territories, and whose buildings and land covering their technical provisions exceed, at the time of the notification of this Directive, the percentage laid down in Article 22 (1) (a) a period expiring no later than 31 December 1998 within which to comply with that provision. Article 46 1. Article 26 of Directive 90/619/EEC shall be deleted. 2. Spain and Portugal, until 31 December 1995, and Greece, until 31 December 1998, may operate the following transitional arrangements for contracts in respect of which one of those Member States is the Member State of the commitment: (a) by way of derogation from Article 8 (3) of Directive 79/267/EEC and from Articles 29 and 39 of this Directive, the competent authorities of the Member States in question may require the communication, before use, of general and special insurance policy conditions; (b) the amount of the technical provisions relating to such contracts shall be determined under the supervision of the Member State concerned in accordance with its own rules or, failing that, in accordance with the procedures established in that State in accordance with this Directive. Cover of those technical provisions by equivalent and matching assets and the localization of those assets shall be effected under the supervision of that Member State in accordance with its rules and practices adopted in accordance with this Directive. TITLE VI FINAL PROVISIONS Article 47 The following technical adjustments to be made to Directives 79/267/EEC and 90/619/EEC and to this Directive shall be adopted in accordance with the procedure laid down in Directive 91/675/EEC: - extension of the legal forms provided for in Article 8 (1) (a) of Directive 79/267/EEC, - amendments to the list set out in the Annex to Directive 79/267/EEC, or adaptation of the terminology used in that list to take account of the development of assurance markets, - clarification of the items constituting the solvency margin listed in Article 18 of Directive 79/267/EEC to take account of the creation of new financial instruments, - alteration of the minimum guarantee fund provided for in Article 20 (2) of Directive 79/267/EEC to take account of economic and financial developments, - amendments, to take account of the creation of new financial instruments, to the list of assets acceptable as cover for technical provisions set out in Article 21 of this Directive and to the rules on the spreading of investments laid down in Article 22 of this Directive, - changes in the relaxations in the matching rules laid down in Annex I to this Directive, to take account of the development of new currency-hedging instruments or progress made in economic and monetary union, - clarification of the definitions in order to ensure uniform application of Directives 79/267/EEC and 90/619/EEC and of this Directive throughout the Community, - the technical adjustments necessary to the rules for setting the maxima applicable to interest rates, pursuant to Article 17 of Directive 79/267/EEC, as amended by this Directive, in particular to take account of progress made in economic and monetary union. Article 48 1. Branches which have started business, in accordance with the provisions in force in their Member State of establishment, before the entry into force of the provisions adopted in implementation of this Directive shall be presumed to have been subject to the procedure laid down in Article 10 (1) to (5) of Directive 79/267/EEC. They shall be governed, from the date of that entry into force, by Articles 17, 23, 24 and 26 of Directive 79/267/EEC and by Article 40 of this Directive. 2. Articles 11 and 14 of Directive 90/619/EEC, as amended by this Directive, shall not affect rights acquired by assurance undertakings carrying on business under the freedom to provide services before the entry into force of the provisions adopted in implementation of this Directive. Article 49 The following Article 31a shall be inserted in Directive 79/267/EEC: 'Article 31a 1. Under the conditions laid down by national law, each Member State shall authorize agencies and branches set up within its territory and covered by this Title to transfer all or part of their portfolios of contracts to an accepting office established in the same Member State if the competent authorities of that Member State or, if appropriate, those of the Member State referred to in Article 30 certify that after taking the transfer into account the accepting office possesses the necessary solvency margin. 2. Under the conditions laid down by national law, each Member State shall authorize agencies and branches set up within its territory and covered by this Title to transfer all or part of their portfolios of contracts to an assurance undertaking with a head office in another Member State if the competent authorities of that Member State certify that after taking the transfer into account the accepting office possesses the necessary solvency margin. 3. If under the conditions laid down by national law a Member State authorizes agencies and branches set up within its territory and covered by this Title to transfer all or part of their portfolios of contracts to an agency or branch covered by this Title and set up within the territory of another Member State it shall ensure that the competent authorities of the Member State of the accepting office or, if appropriate, of the Member State referred to in Article 30 certify that after taking the transfer into account the accepting office possesses the necessary solvency margin, that the law of the Member State of the accepting office permits such a transfer and that the State has agreed to the transfer. 4. In the circumstances referred to in paragraphs 1, 2 and 3 the Member State in which the transferring agency or branch is situated shall authorize the transfer after obtaining the agreement of the competent authorities of the Member State of the commitment, where different from the Member State in which the transferring agency or branch is situated. 5. The competent authorities of the Member States consulted shall give their opinion or consent to the competent authorities of the home Member State of the transferring assurance undertaking within three months of receiving a request; the absence of any response from the authorities consulted within that period shall be considered equivalent to a favourable opinion or tacit consent. 6. A transfer authorized in accordance with this Article shall be published as laid down by national law in the Member State of the commitment. Such transfers shall automatically be valid against policy-holders, assured persons and any other persons having rights or obligations arising out of the contracts transferred. This provision shall not affect the Member States' right to give policy-holders the opinion of cancelling contracts within a fixed period after a transfer.' Article 50 Member States shall ensure that decisions taken in respect of an assurance undertaking under laws, regulations and administrative provisions adopted in accordance with this Directive may be subject to the right to apply to the courts. Article 51 1. Member States shall adopt the laws, regulations and administrative provisions necessary for their compliance with this Directive no later than 31 December 1993 and bring them into force no later than 1 July 1994. They shall forthwith inform the Commission thereof. When they adopt such measures, the Member States shall include references to this Directive or shall make such references when they effect official publication. The manner in which such references are to be made shall be laid down by the Member States. 2. The Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 52 This Directive is addressed to the Member States.

31992L0098

1992

Council Directive 92/98/EEC of 16 November 1992 amending Annex V to Directive 77/93/EEC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(1) , and in particular the first paragraph of Article 13 thereof, Having regard to the proposal from the Commission, Whereas the said Directive laid down that certain plants, plant products and other objects must be subjected to a plant health inspection at the place of production if originating in the Community, before movement within the Community, or in the country of origin or the consignor country, if originating outside the Community, before being permitted to enter the Community; Whereas the application of the Community plant health arrangements to the Community as an area without internal frontiers, and the introduction of protected zones, calls for a revision of Annex V, in particular the structure including the respective titles thereof, as well as the respective lists of commodities subjected to the abovementioned plant health inspection; Whereas this revision should take into account the results of an assessment of plant health risks arising from Community and third country products respectively, which has been based on available more recent scientific evidence, as well as the harmful organisms of Community concern and the related special requirements as laid down in Annexes I, II, III and IV of the said Directive; whereas, in particular, the commodities should be grouped as those being potential carriers of harmful organisms of relevance for the entire Community and those being potential carriers of harmful organisms of relevance for certain protected zones only, irrespective of their origin, Article 1 Annex V to Directive 77/93/EEC is hereby replaced by that which appears in the Annex hereto. Article 2 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by six months after adoption thereof. They shall forthwith inform the Commission thereof. 2. When these measures are adopted by Member States, 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. 3. Member States shall immediately communicate to the Commission all provisions of national law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive is addressed to the Member States.

31992L0100

1992

Council Directive 92/100/EEC of 19 November 1992 on rental right and lending right and on certain rights related to copyright in the field of intellectual property Having regard to the Treaty establishing the European Economic Community, and in particular Articles 57 (2), 66 and 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 differences exist in the legal protection provided by the laws and practices of the Member States for copyright works and subject matter of related rights protection as regards rental and lending; whereas such differences are sources of barriers to trade and distortions of competition which impede the achievement and proper functioning of the internal market; Whereas such differences in legal protection could well become greater as Member States adopt new and different legislation or as national case-law interpreting such legislation develops differently; Whereas such differences should therefore be eliminated in accordance with the objective of introducing an area without internal frontiers as set out in Article 8a of the Treaty so as to institute, pursuant to Article 3 (f) of the Treaty, a system ensuring that competition in the common market is not distorted; Whereas rental and lending of copyright works and the subject matter of related rights protection is playing an increasingly important role in particular for authors, performers and producers of phonograms and films; whereas piracy is becoming an increasing threat; Whereas the adequate protection of copyright works and subject matter of related rights protection by rental and lending rights as well as the protection of the subject matter of related rights protection by the fixation right, reproduction right, distribution right, right to broadcast and communication to the public can accordingly be considered as being of fundamental importance for the Community's economic and cultural development; Whereas copyright and related rights protection must adapt to new economic developments such as new forms of exploitation; Whereas the creative and artistic work of authors and performers necessitates an adequate income as a basis for further creative and artistic work, and the investments required particularly for the production of phonograms and films are especially high and risky; whereas the possibility for securing that income and recouping that investment can only effectively be guaranteed through adequate legal protection of the rightholders concerned; Whereas these creative, artistic and entrepreneurial activities are, to a large extent, activities of self-employed persons; whereas the pursuit of such activities must be made easier by providing a harmonized legal protection within the Community; Whereas, to the extent that these activities principally constitute services, their provision must equally be facilitated by the establishment in the Community of a harmonized legal framework; Whereas the legislation of the Member States should be approximated in such a way so as not to conflict with the international conventions on which many Member States' copyright and related rights laws are based; Whereas the Community's legal framework on the rental right and lending right and on certain rights related to copyright can be limited to establishing that Member States provide rights with respect to rental and lending for certain groups of rightholders and further to establishing the rights of fixation, reproduction, distribution, broadcasting and communication to the public for certain groups of rightholders in the field of related rights protection; Whereas it is necessary to define the concepts of rental and lending for the purposes of this Directive; Whereas it is desirable, with a view to clarity, to exclude from rental and lending within the meaning of this Directive certain forms of making available, as for instance making available phonograms or films (cinematographic or audiovisual works or moving images, whether or not accompanied by sound) for the purpose of public performance or broadcasting, making available for the purpose of exhibition, or making available for on-the-spot reference use; whereas lending within the meaning of this Directive does not include making available between establishments which are accessible to the public; Whereas, where lending by an establishment accessible to the public gives rise to a payment the amount of which does not go beyond what is necessary to cover the operating costs of the establishment, there is no direct or indirect economic or commercial advantage within the meaning of this Directive; Whereas it is necessary to introduce arrangements ensuring that an unwaivable equitable remuneration is obtained by authors and performers who must retain the possibility to entrust the administration of this right to collecting societies representing them; Whereas the equitable remuneration may be paid on the basis of one or several payments an any time on or after the conclusion of the contract; Whereas the equitable remuneration must take account of the importance of the contribution of the authors and performers concerned to the phonogram or film; Whereas it is also necessary to protect the rights at least of authors as regards public lending by providing for specific arrangements; whereas, however, any measures based on Article 5 of this Directive have to comply with Community law, in particular with Article 7 of the Treaty; Whereas the provisions of Chapter II do not prevent Member States from extending the presumption set out in Article 2 (5) to the exclusive rights included in that chapter; whereas furthermore the provisions of Chapter II do not prevent Member States from providing for a rebuttable presumption of the authorization of exploitation in respect of the exclusive rights of performers provided for in those articles, in so far as such presumption is compatible with the International Convention for the Protection of Performers, Producers of Phonograms and Broadcasting Organizations (hereinafter referred to as the Rome Convention); Whereas Member States may provide for more far-reaching protection for owners of rights related to copyright than that required by Article 8 of this Directive; Whereas the harmonized rental and lending rights and the harmonized protection in the field of rights related to copyright should not be exercised in a way which constitutes a disguised restriction on trade between Member States or in a way which is contrary to the rule of media exploitation chronology, as recognized in the Judgment handed down in Société Cinéthèque v. FNCF (4), CHAPTER I RENTAL AND LENDING RIGHT Article 1 Object of harmonization 1. In accordance with the provisions of this Chapter, Member States shall provide, subject to Article 5, a right to authorize or prohibit the rental and lending of originals and copies of copyright works, and other subject matter as set out in Article 2 (1). 2. For the purposes of this Directive, 'rental' means making available for use, for a limited period of time and for direct or indirect economic or commercial advantage. 3. For the purposes of this Directive, 'lending' means making available for use, for a limited period of time and not for direct or indirect economic or commercial advantage, when it is made through establishments which are accessible to the public. 4. The rights referred to in paragraph 1 shall not be exhausted by any sale or other act of distribution of originals and copies of copyright works and other subject matter as set out in Article 2 (1). Article 2 Rightholders and subject matter of rental and lending right 1. The exclusive right to authorize or prohibit rental and lending shall belong: - to the author in respect of the original and copies of his work, - to the performer in respect of fixations of his performance, - to the phonogram producer in respect of his phonograms, and - to the producer of the first fixation of a film in respect of the original and copies of his film. For the purposes of this Directive, the term 'film' shall designate a cinematographic or audiovisual work or moving images, whether or not accompanied by sound. 2. For the purposes of this Directive the principal director of a cinematographic or audiovisual work shall be considered as its author or one of its authors. Member States may provide for others to be considered as its co-authors. 3. This Directive does not cover rental and lending rights in relation to buildings and to works of applied art. 4. The rights referred to in paragraph 1 may be transferred, assigned or subjet to the granting of contractual licences. 5. Without prejudice to paragraph 7, when a contract concerning film production is concluded, individually or collectively, by performers with a film producer, the performer covered by this contract shall be presumed, subject to contractual clauses to the contrary, to have transferred his rental right, subject to Article 4. 6. Member States may provide for a similar presumption as set out in paragraph 5 with respect to authors. 7. Member States may provide that the signing of a contract concluded between a performer and a film producer concerning the production of a film has the effect of authorizing rental, provided that such contract provides for an equitable remuneration within the meaning of Article 4. Member States may also provide that this paragraph shall apply mutatis mutandis to the rights included in Chapter II. Article 3 Rental of computer programs This Directive shall be without prejudice to Article 4 (c) of Council Directive 91/250/EEC of 14 May 1991 on the legal protection of computer programs (5). Article 4 Unwaivable right to equitable remuneration 1. Where an author or performer has transferred or assigned his rental right concerning a phonogram or an original or copy of a film to a phonogram or film producer, that author or performer shall retain the right to obtain an equitable remuneration for the rental. 2. The right to obtain an equitable remuneration for rental cannot be waived by authors or performers. 3. The administration of this right to obtain an equitable remuneration may be entrusted to collecting societies representing authors or performers. 4. Member States may regulate whether and to what extent administration by collecting societies of the right to obtain an equitable remuneration may be imposed, as well as the question from whom this remuneration may be claimed or collected. Article 5 Derogation from the exclusive public lending right 1. Member States may derogate from the exclusive right provided for in Article 1 in respect of public lending, provided that at least authors obtain a remuneration for such lending. Member States shall be free to determine this remuneration taking account of their cultural promotion objectives. 2. When Member States do not apply the exclusive lending right provided for in Article 1 as regards phonograms, films and computer programs, they shall introduce, at least for authors, a remuneration. 3. Member States may exempt certain categories of establishments from the payment of the remuneration referred to in paragraphs 1 and 2. 4. The Commission, in cooperation with the Member States, shall draw up before 1 July 1997 a report on public lending in the Community. It shall forward this report to the European Parliament and to the Council. CHAPTER II RIGHTS RELATED TO COPYRIGHT Article 6 Fixation right 1. Member States shall provide for performers the exclusive right to authorize or prohibit the fixation of their performances. 2. Member States shall provide for broadcasting organizations the exclusive right to authorize or prohibit the fixation of their broadcasts, whether these broadcasts are transmitted by wire or over the air, including by cable or satellite. 3. A cable distributor shall not have the right provided for in paragraph 2 where it merely retransmits by cable the broadcasts of broadcasting organizations. Article 7 Reproduction right 1. Member States shall provide the exclusive right to authorize or prohibit the direct or indirect reproduction: - for performers, of fixations of their performances, - for phonogram producers, of their phonograms, - for producers of the first fixations of films, in respect of the original and copies of their films, and - for broadcasting organizations, of fixations of their broadcasts, as set out in Article 6 (2). 2. The reproduction right referred to in paragraph 1 may be transferred, assigned or subject to the granting of contractual licences. Article 8 Broadcasting and communication to the public 1. Member States shall provide for performers the exclusive right to authorize or prohibit the broadcasting by wireless means and the communication to the public of their performances, except where the performance is itself already a broadcast performance or is made from a fixation. 2. Member States shall provide a right in order to ensure that a single equitable remuneration is paid by the user, if a phonogram published for commercial purposes, or a reproduction of such phonogram, is used for broadcasting by wireless means or for any communication to the public, and to ensure that this remuneration is shared between the relevant performers and phonogram producers. Member States may, in the absence of agreement between the performers and phonogram producers, lay down the conditions as to the sharing of this remuneration between them. 3. Member States shall provide for broadcasting organizations the exclusive right to authorize or prohibit the rebroadcasting of their broadcasts by wireless means, as well as the communication to the public of their broadcasts if such communication is made in places accessible to the public against payment of an entrance fee. Article 9 Distribution right 1. Member States shall provide - for performers, in respect of fixations of their performances, - for phonogram producers, in respect of their phonograms, - for producers of the first fixations of films, in respect of the original and copies of their films, - for broadcasting organizations, in respect of fixations of their broadcast as set out in Article 6 (2), the exclusive right to make available these objects, including copies thereof, to the public by sale or otherwise, hereafter referred to as the 'distribution right'. 2. The distribution right shall not be exhausted within the Community in respect of an object as referred to in paragraph 1, except where the first sale in the Community of that object is made by the rightholder or with his consent. 3. The distribution right shall be without prejudice to the specific provisions of Chapter I, in particular Article 1 (4). 4. The distribution right may be transferred, assigned or subject to the granting of contractual licences. Article 10 Limitations to rights 1. Member States may provide for limitations to the rights referred to in Chapter II in respect of: (a) private use; (b) use of short excerpts in connection with the reporting of current events; (c) ephemeral fixation by a broadcasting organization by means of its own facilities and for its own broadcasts; (d) use solely for the purposes of teaching or scientific research. 2. Irrespective of paragraph 1, any Member State may provide for the same kinds of limitations with regard to the protection of performers, producers of phonograms, broadcasting organizations and of producers of the first fixations of films, as it provides for in connection with the protection of copyright in literary and artistic works. However, compulsory licences may be provided for only to the extent to which they are compatible with the Rome Convention. 3. Paragraph 1 (a) shall be without prejudice to any existing or future legislation on remuneration for reproduction for private use. CHAPTER III DURATION Article 11 Duration of authors' rights Without prejudice to further harmonization, the authors' rights referred to in this Directive shall not expire before the end of the term provided by the Berne Convention for the Protection of Literary and Artistic Works. Article 12 Duration of related rights Without prejudice to further harmonization, the rights referred to in this Directive of performers, phonogram producers and broadcasting organizations shall not expire before the end of the respective terms provided by the Rome Convention. The rights referred to in this Directive for producers of the first fixations of films shall not expire before the end of a period of 20 years computed from the end of the year in which the fixation was made. CHAPTER IV COMMON PROVISIONS Article 13 Application in time 1. This Directive shall apply in respect of all copyright works, performances, phonograms, broadcasts and first fixations of films referred to in this Directive which are, on 1 July 1994, still protected by the legislation of the Member States in the field of copyright and related rights or meet the criteria for protection under the provisions of this Directive on that date. 2. This Directive shall apply without prejudice to any acts of exploitation performed before 1 July 1994. 3. Member States may provide that the rightholders are deemed to have given their authorization to the rental or lending of an object referred to in Article 2 (1) which is proven to have been made available to third parties for this purpose or to have been acquired before 1 July 1994. However, in particular where such an object is a digital recording, Member States may provide that rightholders shall have a right to obtain an adequate remuneration for the rental or lending of that object. 4. Member States need not apply the provisions of Article 2 (2) to cinematographic or audiovisual works created before 1 July 1994. 5. Member States may determine the date as from which the Article 2 (2) shall apply, provided that that date is no later than 1 July 1997. 6. This Directive shall, without prejudice to paragraph 3 and subject to paragraphs 8 and 9, not affect any contracts concluded before the date of its adoption. 7. Member States may provide, subject to the provisions of paragraphs 8 and 9, that when rightholders who acquire new rights under the national provisions adopted in implementation of this Directive have, before 1 July 1994, given their consent for exploitation, they shall be presumed to have transferred the new exclusive rights. 8. Member States may determine the date as from which the unwaivable right to an equitable remuneration referred to in Article 4 exists, provided that that date is no later than 1 July 1997. 9. For contracts concluded before 1 July 1994, the unwaivable right to an equitable remuneration provided for in Article 4 shall apply only where authors or performers or those representing them have submitted a request to that effect before 1 January 1997. In the absence of agreement between rightholders concerning the level of remuneration, Member States may fix the level of equitable remuneration. Article 14 Relation between copyright and related rights Protection of copyright-related rights under this Directive shall leave intact and shall in no way affect the protection of copyright. Article 15 Final provisions 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1994. 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 at the time 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 main provisions of domestic law which they adopt in the field covered by this Directive. Article 16 This Directive is addressed to the Member States.

31992L0101

1992

Council Directive 92/101/EEC of 23 November 1992 amending Directive 77/91/EEC on the formation of public limited- liability companies and the maintenance and alteration of their capital Having regard to the Treaty establishing the European Economic Community, and in particular Article 54 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 in order to maintain the subscribed capital and ensure equal treatment of shareholders, Directive 77/91/EEC (4) restricts a public limited-liability company's right to acquire its own shares; Whereas the restrictions on a company's acquisition of its own shares apply not only to acquisitions made by a company itself but also to those made by any person acting in his own name but on the company's behalf; Whereas in order to prevent a public limited-liability company from using another company in which it holds a majority of the voting rights or on which it can exercise a dominant influence to make such acquisitions without complying with the restrictions imposed in that respect, the arrangements governing a company's acquisition of its own shares should be extended to cover the most important and most frequent cases of the acquisition of shares by such other companies; whereas those arrangements should be extended to cover subscription for shares in the public limited-liability company; Whereas in order to prevent the circumvention of Directive 77/91/EEC companies governed by Directive 68/151/EEC (5) and companies governed by the laws of third countries and having comparable legal forms should also be covered; Whereas, where the relationship between a public limited-liability company and another company such as referred to in the third recital is only indirect, it would appear to be justified to relax the provisions applicable when that relationship is direct by providing for the suspension of voting rights as a minimum measure for the purpose of achieving the aims of this Directive; Whereas, where a Member State provides for a system of penalties equivalent to those laid down in Directive 77/91/EEC and for the suspension of voting rights, it may be considered that such legislation already meets the objectives of this Directive; Whereas, furthermore, it is justifiable to exempt cases in which the specific nature of a professional activity rules out the possibility that the objectives of this Directive may be endangered; Whereas, in order to avoid the disturbance of a Member State's financial market as a result of that country's economic structure and excessively abrupt consequences as regards the rules for self-regulation, provision should be made for an appropriate adaptation period, Article 1 The following Article shall be inserted after Article 24 of Directive 77/91/EEC: 'Article 24a 1. (a) The subscription, acquisition or holding of shares in a public limited-liability company by another company within the meaning of Article 1 of Directive 68/151/EEC in which the public limited-liability company directly or indirectly holds a majority of the voting rights or on which it can directly or indirectly exercise a dominant influence shall be regarded as having been effected by the public limited-liability company itself; (b) subparagraph (a) shall also apply where the other company is governed by the law of a third country and has a legal form comparable to those listed in Article 1 of Directive 68/151/EEC. 2. However, where the public limited-liability company holds a majority of the voting rights indirectly or can exercise a dominant influence indirectly, Member States need not apply paragraph 1 if they provide for the suspension of the voting rights attached to the shares in the public limited-liability company held by the other company. 3. In the absence of coordination of national legislation on groups of companies, Member States may: (a) define the cases in which a public limited-liability company shall be regarded as being able to exercise a dominant influence on another company; if a Member State exercises this option, its national law must in any event provide that a dominant influence can be exercised if a public limited-liability company: - has the right to appoint or dismiss a majority of the members of the administrative organ, of the management organ or of the supervisory organ, and is at the same time a shareholder or member of the other company or - is a shareholder or member of the other company and has sole control of a majority of the voting rights of its shareholders or members under an agreement concluded with other shareholders or members of that company. Member States shall not be obliged to make provision for any cases other than those referred to in the first and second indents; (b) define the cases in which a public limited-liability company shall be regarded as indirectly holding voting rights or as able indirectly to exercise a dominant influence; (c) specify the circumstances in which a public limited-liability company shall be regarded as holding voting rights. 4. (a) Member States need not apply paragraph 1 where the subscription, acquisition or holding is effected on behalf of a person other than the person subscribing, acquiring or holding the shares, who is neither the public limited-liability company referred to in paragraph 1 nor another company in which the public limited-liability company directly or indirectly holds a majority of the voting rights or on which it can directly or indirectly exercise a dominant influence. (b) Member States need not apply paragraph 1 where the subscription, acquisition or holding is effected by the other company in its capacity and in the context of its activities as a professional dealer in securities, provided that it is a member of a stock exchange situated or operating within a Member State, or is approved or supervised by an authority of a Member State competent to supervise professional dealers in securities which, within the meaning of this Directive, may include credit institutions. 5. Member States need not apply paragraph 1 where shares in a public limited-liability company held by another company were acquired before the relationship between the two companies corresponded to the criteria laid down in paragraph 1. However, the voting rights attached to those shares shall be suspended and the shares shall be taken into account when it is determined whether the condition laid down in Article 19 (1) (b) is fulfilled. 6. Member States need not apply Article 20 (2) or (3) or Article 21 where shares in a public limited-liability company are acquired by another company on condition that they provide for: (a) the suspension of the voting rights attached to the shares in the public limited-liability company held by the other company, and (b) the members of the administrative or the management organ of the public limited-liability company to be obliged to buy back from the other company the shares referred to in Article 20 (2) and (3) and Article 21 at the price at which the other company acquired them; this sanction shall be inapplicable only where the members of the administrative or the management organ of the public limited-liability company prove that that company played no part whatsoever in the subscription for or acquisition of the shares in question.' Article 2 1. Member States need not apply Article 24a of Directive 77/91/EEC to shares acquired before the date referred to in Article 3 (2). However, the voting rights attached to those shares shall be suspended and the shares shall be taken into account when it is determined whether the condition laid down in Article 19 (1) (b) of the same Directive is fulfilled. 2. In order to avoid disturbance of the financial market, the Kingdom of Belgium may postpone the suspension of such voting rights until 1 January 1998 on condition that: - they are attached to shares acquired before the notification of this Directive and, - for all companies the relationship of which with a public limited-liability company meets the criteria laid down in Article 24a (1) of Directive 77/91/EEC, they do not exceed 10 % of the voting rights attached to the shares in the public limited-liability company. Article 3 1. Member States shall adopt before 1 January 1994 the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. 2. The date of entry into force which Member States shall lay down for those provisions shall be no later than 1 January 1995. 3. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. 4. When Member States adopt these measures, they shall include a reference to this Directive or shall be accompanied by such a reference at the time of their official publication. The manner in which such a reference is to be made shall be laid down by the Member States. Article 4 This Directive is addressed to the Member States.

31992L0102

1992

Council Directive 92/102/EEC of 27 November 1992 on the identification and registration of animals Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Whereas Article 3 (1) (c) of Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnicial checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (3), states that animals for intra-Community trade must be identified in accordance with the requirements of Community rules and be registered in such a way that the original or transit holding, centre or organization can be traced, and that before 1 January 1993 these identification and registration systems are to be extended to the movements of animals with the territory of each Member State; Whereas Article 14 of Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC (4), states that the identification and registration as provided for in Article 3 (1) (c) of Directive 90/425/EEC of such animals must, except in the case of animals for slaughter and registered equidae, be carried out after the said checks have been made; Whereas the management of certain Community aid schemes in the field of agriculture requires the individual identification of certain types of livestock; whereas the identification and registration system must, therefore, be suitable for the application and control of such measures; Whereas it is necessary to ensure the rapid and efficient exchange of information between Member States for the correct application of this Directive; whereas Community provisions have been established by Council Regulation (EEC) No 1468/81 of 19 May 1981 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs or agricultural matters (5) and by Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters (6); Whereas keepers of animals must maintain up-to-date records of the animals on their holdings; whereas persons involved in the commerce of animals must keep records of their dealings; whereas the competent authority must have access to these records on request; Whereas in order to permit movements of animals to be traced rapidly and accurately, animals must be able to be identified; whereas the form and content of the mark, with respect to bovine animals, must be determined on a Community basis; whereas, with regard to pigs, sheep and goats, a decision should be taken at a later date to determine the nature of the mark and, pending such decision, the national systems of identification should be maintained for movements restricted to the national market; Whereas provision should be made for the possibility of waiving the requirements for marks in the case of animals moving directly from a farm to a slaughterhouse; whereas, however, these animals must in any case be identified so that their farm of origin can be traced; Whereas provision should be made for the possibility of waiving the obligation to register the keepers of animals kept for personal purposes and, in order to take into account certain particular cases, the procedures for keeping registers; Whereas in the case of animals in which the mark has become illegible or been lost, a new mark enabling a link with the previous mark to be established must be applied; Whereas this Directive must not affect specific requirements contained in Commission Decision 89/153/EEC of 13 February 1989 concerning the correlation of samples taken for residue examination with animals and their farms of origin (7) or any relevant applicatory rules established in accordance with Directive 91/496/EEC; Whereas provision must be made for a management committee procedure for the adoption of any necessary implementing rules for this Directive, Article 1 This Directive sets out the minimum requirements for the identification and registration of animals, without prejudice to more detailed Community rules which may be established for disease eradication or control purposes. It shall apply without prejudice to Decision 89/153/EEC and to implementing rules laid down in accordance with Directive 91/496/EEC, and taking account of Article 5 of Council Regulation (EEC) No 3508/92 of 27 November 1992 establishing an integrated administration and control system for certain Community aid schemes (8). Article 2 For the purposes of this Directive: (a) animal shall mean any animal of the species referred to in Directives 64/432/EEC (9) and 91/68/EEC (10); (b) holding shall mean any establishment, construction or, in the case of an open-air farm, any place in which animals are held, kept or handled; (c) keeper shall mean any natural or legal person responsible, even on a temporary basis, for animals; (d) competent authority shall mean the central authority of a Member State competent to carry out veterinary checks or any authority to which it has delegated that competence for the purposes of implementing this Directive; (e) trade shall mean trade as defined in Article 2 of Directive 90/425/EEC. Article 3 1. Member States shall ensure that: (a) the competent authority has an up-to-date list of all the holdings which keep animals covered by this Directive and are situated on its territory, specifying the species of animals kept and their keepers, such holdings to remain on the said list until three consecutive years have elapsed with no animals on the holding. This list shall also include the mark or marks which permit the identification of the holding in accordance with Article 5 (2) (a) and (c), second subparagraph, and paragraph (3), first subparagraph, and also Article 8; (b) the Commission, the competent authority and any authority responsible for supervising application of Regulation (EEC) No 3508/92 can have access to all information obtained under this Directive. 2. Member States may be authorized under the procedure laid down in Article 18 of Directive 90/425/EEC to exclude from the list in paragraph 1 (a) natural persons who keep no more than three animals of the ovine or caprine species for which they do not seek premiums or, to take account of particular circumstances, one pig and which are intended for their own use or consumption, provided that any such animals are the subject of the controls laid down in this Directive before any movement. Article 4 1. Member States shall ensure that: (a) any keeper of bovine or porcine animals listed in Directive 64/432/EEC and contained in the list provided for in Article 3 (1) (a) keeps a register stating the number of animals present on the holding. This register shall include an up-to-date record of all births, deaths and movements (numbers of animals concerned by each entering and leaving operation) at least on the basis of aggregate movements, stating as appropriate their origin or destination, and the date of such movements. The identification mark applied in conformity with Articles 5 and 8 shall be stated in all cases. However, for animals of the porcine species, it shall not be obligatory to include births and deaths. In the case of pure-bred and hybrid pigs, which are entered in a herd book in accordance with Directive 88/661/EEC (11), an alternative registration system based on individual identification allowing the animals to be identified may be recognized by the procedure laid down in Article 18 of Directive 90/425/EEC if it offers guarantees equivalent to a register; (b) any keeper of sheep or goats whose holding is listed in accordance with Article 3 (1) (a) shall keep a register including at least the total number of sheep and goats present on the holding each year on a date to be determined by the competent authority. The register shall also include: - an up-to-date statement of the number of live female sheep and goats which are over 12 months of age or which have given birth present on the holding; - the movements (numbers of animals concerned by each entering or leaving operation) of sheep and goats on at least the basis of aggregate movements stating as appropriate their origin or destination, their mark and the date of such movements. 2. However, in accordance with the procedure laid down in Article 18 of Directive 90/425/EEC, a simplified registration procedure shall be established before 1 January 1993 for buffalo and before 1 October 1994 for sheep and goats in transhumance and for all the abovementioned animals kept on common pasture or raised in regions which are isolated geographically. 3. Member States shall also ensure that: (a) any keeper supplies the competent authority, upon request, with all information concerning the origin, identification and, where appropriate, the destination of animals which he has owned, kept, transported, marketed or slaughtered; (b) any keeper of animals to be moved to or from a market or collection centre provides a document, setting out details of the animals including the identification numbers or marks of any bovine animals, to the operator, on the market or in the collection centre, who is a keeper of the animals, on a temporary basis. That operator may use the documents obtained in accordance with the first subparagraph to carry out the obligations laid down in paragraph 1 (a), third subparagraph. (c) the registers and information are available on the holding and to the competent authority, upon request, for a minimum period to be determined by the competent authority but which may not be less than three years. Article 5 1. Member States shall ensure that the following general principles are respected: (a) identification marks must be applied before animals leave the holding of birth; (b) no mark may be removed or replaced without the permission of the competent authority. Where a mark has become illegible or has been lost, a new mark shall be applied in accordance with this Article; (c) the keeper shall record any new mark in the register referred to in Article 4 in order to establish a link with the previous mark applied to the animal; (d) the eartag provided for in paragraph 2 (a) shall be approved by the competent authority and shall be tamper-proof and easy to read for the animal's lifetime. It shall be incapable of re-use. It shall be such as to remain on the animal without interfering with its well-being. 2. For bovine animals, Member States shall ensure that: (a) all animals listed in Article 2 of Directive 64/432/EEC present on the holding are identified with an eartag bearing on alphanumeric code, which shall not exceed 14 characters, which make it possible to identify each animal individually along with the holding on which it was born or, in the case of bulls intended for cultural and sporting events with the exception of fairs and exhibitions, by an identification system offering equivalent guarantees recognized by the Commission. The eartags referred to in the first subparagraph must be applied no later than nine months after the date of adoption, in accordance with the procedure laid down in Article 18 of Directive 90/425/EEC of measures providing for the identification of the Member State and the holding of origin. Animals identified before the end of this nine-month period must be marked either in accordance with the national systems provided for in the third subparagraph or with the eartag provided for in the first subparagraph. Under the procedure laid down in Article 18 of Directive 90/425/EEC such period shall be at the request of a Member State, be extended until 1 July 1994. However, animals which have been identified before the expiry of the nine-month period in accordance with the national systems in force and notified to the Commission shall continue to be subject to control on that basis; (b) the identification marks are allocated to the holding, distributed and applied to the animals in a manner determined by the competent authority; (c) the identification marks are applied, at the latest, within thirty days of the birth of the animal. However, the competent authority may defer the application of this mark until the animal has attained a maximum age of six months, if the animal is, before the age of 30 days, provided by the keeper with a provisional mark recognized by the competent authority which makes it possible to identify each animal to the holding of birth, and provided that these animals may not leave the holding except for slaughter in a slaughterhouse situated in the territory of the competent authority which has recognized the provisional mark, without passing through any other holding. However, the competent authority may permit vealcalves intended for slaughter before the age of six months and which are moved before the age of 30 days in accordance with a national system of movement, recognized in accordance with the procedure laid down in Article 18 of Directive 90/425/EEC, which provides at least for tracing back to the holding of origin, to be marked at the fattening holding, provided that the calves were transferred there directly from the holding of birth and that the calves moved under such systems will not be eligible for premiums. 3. Animals other than bovine animals must be marked as soon as possible, and in any case before they leave the holding, with an eartag or tattoo making it possible to determine the holding from which they came and enabling reference to be made to any accompanying document which must mention such eartag or tattoo and to the list referred to in Article 3 (1) (a). Member States may, pending the decision provided for in Article 10 of this Decision and by derogation from the second paragraph of Article 3 (1) (c) of Directive 90/425/EEC, apply their national systems for the movement of animals other than bovine animals for all movements of such animals in their territories. Such systems must enable the holding from which they came and the holding on which they were born to be identified. Member States shall notify the Commission of the systems which they intend to introduce for this purpose, on 1 July 1993 for pigs and on 1 July 1994 for sheep and goats. In accordance with the procedure laid down in Article 18 of Directive 90/425/EEC, a Member State may be asked to make amendments to its system where it does not fulfil the requirement referred to in the second sentence. Animals bearing a temporary mark identifying a consignment must be accompanied throughout their movement by a document which enables the origin, ownership, place of departure and destination to be determined. However, the competent authority may authorize the movement of sheep and goats without marks between holdings with the same health status in the same ownership and situated in that authority's territory, provided that each such movement occurs under a national system which enables the animal to be traced back to the holding on which it was born. Member States must notify by 1 July 1994 the Commission of the systems which they intend introducing to this end. Pursuant to the procedure laid down in Article 18 of Directive 90/425/EEC, a Member State may be requested to amend this system where it fails to meet the aforementioned requirement. 4. Point (e) of Article 3 (2) of Directive 64/432/EEC shall read: '(e) be identified in accordance with Article 5 of 32.' Council Directive 92/102/EEC on the identification and registration of animals (*). (*) OJ No L 355, 5. 12. 1992, p. 32.' Article 6 1. Where the competent authority of the Member State of destination decides not to keep the identification mark allocated to the animal in the holding of origin all charges incurred as a result of replacing the mark shall be borne by that authority. Where the mark has been so replaced, a link shall be established between the identification allocated by the competent authority of the Member State of dispatch and the new identification allocated by the competent authority of the Member State of destination; that link shall be recorded in the register provided for in Article 4. The option in the first subparagraph may not be invoked in the case of animals intended for slaughter which are imported under Article 8 without bearing a new mark in accordance with Article 5. 2. Where the animals have been traded, the competent authority of the Member State of destination may, for the purposes of Article 5 of Directive 90/425/EEC, have recourse to Article 4 of Directive 89/608/EEC in order to obtain the information relating to the animals, their herd of origin and any movement to which they have been subject. Article 7 Member States shall ensure that any information relating to movements of animals not accompanied by a certificate or a document required by veterinary or zootechnical legislation remains available to the competent authority, upon request, for a minimum period to be set by the latter. Article 8 Any animal imported from a third country which has passed the checks laid down by Directive 91/496/EEC and which remains within Community territory shall, within thirty days of undergoing the aforesaid checks, and, in any event, before their movement, be identified by a mark complying with Article 5 unless the holding of destination is a slaughterhouse situated on the territory of the competent authority responsible for veterinary checks and the animal is actually slaughtered within that 30-day period. A link shall be established between the identification established by the third country and the identification allocated to it by the Member State of destination. That link shall be recorded in the register provided for in Article 4. Article 9 Member States shall adopt necessary administrative and/or penal measures to punish any infringement of Community veterinary legislation, where it is established that the marking or identification or the keeping of registers provided for in Article 4 has not been carried out in conformity with the requirements of this Directive. Article 10 Not later than 31 December 1996, acting on the basis of a report from the Commission, accompanied by any proposals, on which it will decide by a qualified majority the Council shall, in the light of experience gained, review the provisions of this Directive with a view to defining a harmonized Community identification and registration system and shall decide on the possibility of introducing electronic identification arrangements in the light of progress achieved in this field by the International Organization for Standardization (ISO). Article 11 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply wiht this Directive: - for the requirements regarding bovine animals, so that: (i) the bovine animals, as from 1 February 1993, are registered in accordance with existing national procedures complying with the requirements laid down in Article 4 and are identified in accordance with the existing rules referred to in Article 5 (2) (a), second and third subparagraph; (ii) the Community registration and identification systems laid down by this Directive are set up as from 1 October 1993, - before 1 January 1994 for the requirements regarding porcine animals, - before 1 January 1995 for the requirements regarding ovine and caprine animals. 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 a 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 texts of the main provisions of national law which they adopt in the field governed by this Directive. 3. The setting of the deadline for transposition into national law at 1 January 1994 and 1 January 1995 shall be without prejudice to the abolition of veterinary checks at frontiers provided for in Directive 90/425/EEC. Article 12 This Directive is addressed to the Member States.

31992L0103

1992

Commission Directive 92/103/EEC of 1 December 1992 amending Annexes I to IV to Council Directive 77/93/EEC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), as last amended by Commission Directive 92/10/EEC (2), and in particular Article 3 (6), Article 4 (3) and Article 5 (3) thereof, Whereas the relevant harmful organisms, whose presence is or may be prohibited in trade are listed in Annexes I and II to Directives 77/93/EEC; Whereas a list of commodities which are subject to an import ban under some conditions or which may be subjected by individual Member States to an import ban is given in Annex III to the said Directive; Whereas Annex IV to the said Directive lists special requirements which are to be met in order to have better guarantees of freedom from the abovementioned harmful organisms; Whereas the application of the Community plant health regime to the Community as an area without internal frontiers, and the introduction of protected zones will necessitate a complete restructuring of the Annexes; Whereas this restructuring should take into account the results of an assessment of plant health risks arising from Community and third country products respectively, which has been based on available more recent scientific evidence, as well as the harmful organisms of Community concern and the related special requirements as laid down in Annexes I, II, III and IV to the said Directive; Whereas this restructuring should lead to a listing of the harmful organisms subdivided in organisms not known to occur in any part of the Community and relevant for the entire Community, organisms know to occur in the Community and relevant for the entire Community, and organisms of relevance for certain protected zones; whereas moreover, the harmful organisms established in certain parts of the Community and the related requirements should be deleted; Whereas developments in classification, nomenclature or identification of harmful organisms should be taken into account in order to have a correct taxonomic designation of harmful organisms; Whereas developments in scientific and technical knowledge have shown that protection of Community crops should be improved, wherever they are at risk; Whereas, following the intentions declared by the Commission and all Member States at the time of adoption of Council Directive 85/574/EEC (1), Annexes II (B), III (B) and IV (B) to Directive 77/93/EEC should be amended accordingly, but only as an interim protective measure for a limited period to enable the Commission to study their phytosanitary basis case by case; whereas these studies are finalized so that more permanent provisions should be laid down where needed; Whereas the relevant Annexes to Directive 77/93/EEC should therefore be replaced; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 The Annexes I to IV to Directive 77/93/EEC are hereby replaced by the Annex hereto. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive six months after the revision of Annex V to Directive 77/93/EEC. 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 immediately communicate to the Commission all provisions of domestic law which adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive is addressed to the Member States.

31992L0104

1992

COUNCIL DIRECTIVE 92/104/EEC of 3 December 1992 on the minimum requirements for improving the safety and health protection of workers in surface and underground mineral-extracting industries (twelfth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) Having regard to the Treaty establishing the European Economic Community, and in particular Article 118a thereof, Having regard to the proposal from the Commission (1), drawn up after consultation with the Safety and Health Commission for the Mining and Other Extractive Industries, In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Article 118a of the Treaty provides that the Council shall adopt, by means of Directives, minimum requirements for encouraging improvements, especially in the working environment, to guarantee a better level of protection of the safety and health of workers; Whereas, pursuant to that Article, such Directives must avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings; Whereas the improvement of workers' safety, hygiene and health at works is an objective which should not be subordinated to purely economic considerations; Whereas Council Directive 89/654/EEC of 30 November 1989 concerning the minimum safety and health requirements for the workplace (first individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) (4) does not apply to the extractive industries; Whereas compliance with the minimum requirements designed to guarantee a better standard of safety and health for surface and underground mineral-extracting industries is essential to ensure the safety and health of workers; Whereas surface and underground mineral-extracting industries constitute an area of activity likely to expose workers to particularly high levels of risk; Whereas this Directive is an individual Directive within the meaning of Article 16 (1) of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (5); whereas, therefore, the provisions of the said Directive apply in full to surface and underground mineral-extracting industries without prejudice to more stringent and/or specific provisions contained in this Directive; Whereas the ancillary surface installations of surface and underground mineral-extracting industries which are not essential to the surface and underground mineral-extracting industries as defined in Article 2 (a) of this Directive are subject to the provisions of Directive 89/654/EEC; Whereas, on 3 November 1992, the Council adopted Directive 92/91/EEC on the minimum requirements for improving the safety and health protection of workers in the mineral-extracting industries through drilling (eleventh individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) (6); Whereas this Directive is a practical contribution towards creating the social dimension of the internal market, SECTION I GENERAL PROVISIONS Article 1 Subject 1. This Directive, which is the twelfth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC, lays down minimum requirements for the safety and health protection of workers in the surface and underground mineral-extracting industries defined in Article 2 (a). 2. The provisions of Directive 89/391/EEC shall apply in full to the sphere referred to in paragraph 1, without prejudice to more stringent and/or specific provisions contained in this Directive. Article 2 Definitions For the purpose of this Directive: (a) surface and underground mineral-extracting industries shall mean all industries practising: — surface or underground extraction, in the strict sense of the word, of minerals, and/or — prospecting with a view to such extraction, and/or — preparation of extracted materials for sale, excluding the activities of processing the materials extracted, excluding the mineral-extracting industries through drilling defined in Article 2 (a) of Directive 92/91/EEC; (b) workplace shall mean the whole area intended to house workstations, relating to the immediate and ancillary activities and installations of the surface or underground mineral-extracting industries, including overburden dumps and other tips and accommodation, where provided, to which workers have access in the context of their work. SECTION II EMPLOYERS' OBLIGATIONS Article 3 General obligations 1. To safeguard the safety and health of workers, the employer shall take the necessary measures to ensure that: (a) workplaces are designed, constructed, equipped, commissioned, operated and maintained in such a way that workers can perform the work assigned to them without endangering their safety and/or health and/or those of other workers; (b) the operation of workplaces when workers are present takes place under the supervision of a person in charge; (c) work involving a special risk is entrusted only to competent staff and carried out in accordance with the instructions given; (d) all safety instructions are comprehensible to all the workers concerned; (e) appropriate first-aid facilities are provided; (f) any relevant safety drills are performed at regular intervals. 2. The employer shall ensure that a document concerning safety and health, hereinafter referred to as ‘safety and health document’, covering the relevant requirements laid down in Articles 6, 9 and 10 of Directive 89/391/EEC, is drawn up and kept up to date. The safety and health document shall demonstrate in particular that: — the risks to which workers at the workplace are exposed have been determined and assessed, — adequate measures will be taken to attain the aims of this Directive, — the design, use and maintenance of the workplace and of the equipment are safe. The safety and health document must be drawn up before work starts and be revised if the workplace has undergone major changes, extensions or conversions. 3. Where workers from several undertakings are present at the same workplace, each employer shall be responsible for all matters under his control. The employer who, in accordance with national laws and/or practices, is in charge of the workplace, shall coordinate the implementation of all the measures concerning the safety and health of the workers and shall state, in his safety and health document, the aim of that coordination and the measures and procedures for implementing it. The coordination shall not affect the responsability of the individual employers as provided for in Directive 89/391/EEC. 4. The employer shall report any serious and/or fatal occupational accidents and situations of serious danger to the competent authorities as soon as possible. Article 4 Protection from fire, explosions and health-endangering atmospheres The employer shall take measures and precautions appropriate to the nature of the operation: — to avoid, detect and combat the starting and spread of fires and explosions, and — to prevent the occurrence of explosive and/or health-endangering atmospheres. Article 5 Escape and rescue facilities The employer shall provide and maintain appropriate means of escape and rescue in order to ensure that workers have adequate opportunities for leaving the workplaces promptly and safely in the event of danger. Article 6 Communication, warning and alarm systems The employer shall take the requisite measures to provide the necessary warning and other communication systems to enable assistance, escape and rescue operations to be launched immediately if the need arises. Article 7 Keeping workers informed 1. Without prejudice to Article 10 of Directive 89/391/EEC, workers and/or their representatives shall be informed of all measures to be taken concerning safety and health at workplaces, and in particular of those relating to the implementation of Articles 3 to 6. 2. The information must be comprehensible to the workers concerned. Article 8 Health surveillance 1. To ensure that workers receive health surveillance appropriate to the health and safety risks they incur at work, measures shall be introduced in accordance with national law and/or practices. 2. The measures referred to in paragraph 1 shall be such that each worker shall be entitled to, or shall undergo, health surveillance before being assigned to duties related to the activities referred to in Article 2 and subsequently at regular intervals. 3. Health surveillance may be provided as part of a national health system. Article 9 Consultation of workers and workers' participation Consultation and participation of workers and/or of their representatives shall take place in accordance with Article 11 of Directive 89/391/EEC on the matters covered by this Directive. Article 10 Minimum requirements for safety and health 1. Workplaces used for the first time after the date on which this Directive is brought into effect as referred to in Article 13 (1) must satisfy the minimum safety and health requirement laid down in the Annex. 2. Workplaces already in use before the date on which this Directive is brought into effect as referred to in Article 13 (1) must satisfy the minimum safety and health requirements laid down in the Annex as soon as possible and at the latest nine years after that date. 3. When workplaces undergo changes, extensions and/or conversions after the date on which this Directive is brought into effect as referred to in Article 13 (1), the employer shall take the measures necessary to ensure that those changes, extensions and/or conversions are in compliance with the corresponding minimum requirements laid down in the Annex. SECTION III OTHER PROVISIONS Article 11 Adjustments to the Annex Purely technical adjustments to the Annex in line with: — the adoption of Directive in the field of technical harmonization and standardization concerning surface or underground mineral-extracting industries, and/or — technical progress, changes in international regulations or specifications, and new findings concerning the surface or underground mineral-extracting industries, shall be adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC. Article 12 Mineral-extraction by dredging Member States shall be entitled not to apply this Directive to mineral-extraction by dredging provided that they ensure the protection of the workers concerned in line with the general principles of the protection of the safety and health of workers laid down in this Directive, taking into account the specific risks involved in mineral-extraction by dredging. Article 13 Final provisions 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 24 months after its adoption. They shall forthwith inform the Commission thereof. 2. When Member States adopt the measures referred to in paragraph 1, the measures 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 Member States. 3. Member States shall communicate to the Commission the texts of the provisions of national law which they have already adopted, or are to adopt, in the field governed by this Directive. 4. Member States shall report to the Commission every five years on the practical implementation of this Directive, indicating the views of employers and workers. The Commission shall inform the European Parliament, the Council, the Economic and Social Committee, the Safety and Health Commission for the Mining and Other Extractive Industries and the Advisory Committee on Safety, Hygiene and Health Protection at Work thereof. Article 14 This Directive is addressed to the Member States.

31992L0105

1992

Commission Directive 92/105/EEC of 3 December 1992 establishing a degree of standardization for plant passports to be used for the movement of certain plants, plant products or other objects within the Community, and establishing the detailed procedures related to the issuing of such plant passports and the conditions and detailed procedures for their replacement Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), as last amended by Commission Directive 92/10/EEC (2), and in particular Article 2 (1) (f) second subparagraph, and Article 10 (4) thereof, Whereas the application of the Community plant-health system to the Community as an area without internal frontiers will necessitate plant-health checks on potentially hazardous Community products before their movement within the Community; whereas the most appropriate place for carrying out these checks is the place of production of producers listed in an official register; Whereas, if the result of these checks is satisfactory, instead of the phytosanitary certificate used in international trade, a plant passport adapted to the type of product must be attached to the plants, to their packaging or to the vehicle transporting them, to ensure its free movement throughout the Community or those parts thereof for which it is valid; Whereas, in the case of plants, plant products or other objects originating outside the Community, which have successfully undergone the required plant-health checks on first introduction into the Community, a plant passport must also be attached for the same purpose; Whereas it is necessary to provide for a standardized layout for the different types of plants or plant products; Whereas, however, during an initial phase a system making use of a simplified plant passport with a degree of standardization should be used in order to make it possible for plants, plant products or other objects to be moved, as from 1 January 1993; whereas this system will be reconsidered on the basis of an assessment of the gained during the said phase; Whereas, if one plant passport is to be replaced by another, a special mark must be defined for the replacement passport; Whereas, with a view to ensuring that the movement of plants, plant products or other objects by Member States is properly monitored, it is necessary to establish more detailed and more uniform procedures for the issuing and replacement of plant passports; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 1. Member States shall ensure that the conditions laid down in paragraph 2 are met when a plant passport referred to in Article 2 (1) (f), first subparagraph, of Council Directive 77/93/EEC is prepared by their responsible official bodies for use in accordance with the provisions of Articles 2 and 3 of this Directive. 2. The following conditions shall be met: (a) the plant passport shall consist of an official label and an accompanying document containing the required information as laid down in the Annex hereto. The label shall not have previously been used and shall be of suitable material. The use of official adhesive labels shall be authorized. The 'accompanying document' shall mean any document which is normally used for trade purposes. This document shall not be necessary if the required information as laid down in the Annex is set out on the said label; (b) the required information shall preferably be printed and shall be in at least one of the official languages of the Community; (c) in the case of a plant passport for tubers of Solanum tuberosum L., intended for planting, it shall be the official label as specified in Council Directive 66/403/EEC (3). Compliance with the provisions governing the introduction of seed potatoes into, and their movement within, a protected zone recognized in respect of harmful organisms relating to seed potatoes, shall be noted either on the label or on any other trade document. 3. Member States shall require that when the plant passport consists of the label and the accompanying document: (a) the part of the plant passport consisting of the label shall provide at least the particulars required under items 1 to 5 of the Annex; and (b) the part of the plant passport consisting of the accompanying document shall provide at least the particulars required under items 1 to 10 of the Annex. 4. Any particulars other than those listed in the Annex, of relevance for labelling purposes under Council Directives 91/682/EEC (4), 92/33/EEC (5) or 92/34/EEC (6) may also be provided on the said accompanying document, but shall be clearly separated from the information specified in the Annex. Article 2 1. Member States shall ensure that the conditions laid down in paragraph 2 are met when a plant passport is produced, printed and stored. 2. The plant passport shall be produced, printed and/or subsequently stored either by the responsible official bodies referred to in Article 1 (1) directly, or - under their control - by the producer referred to in Article 6 (4), third subparagraph, or person referred to in Article 10 (3), second indent, or importer referred to in Article 12 (6), second subparagraph of Directive 77/93/EEC. Article 3 1. Member States shall ensure that the conditions laid down in paragraph 2 are met when a plant passport is issued and attached to plants, plant products or other objects, to their packaging or to the vehicles transporting them. The issuing includes the preparation of the passport, in particular the filling-in of the information, and the action necessary to make the plant passport available for use by the applicant. 2. For the purpose of paragraph 1, the responsible official bodies referred to in Article 1 (1) shall, without prejudice to the requirements laid down in Directive 77/93/EEC: (a) ensure that the producer, person or importer referred to in Article 2 (2) applies to them for the issuance of a plant passport, or for the replacement of a plant passport; (b) determine, where appropriate, on the basis of examinations provided for in Article 6 (1) (2) and (3) of Directive 77/93/EEC and carried out in accordance with Article 6 (4) or on the basis of the requirements laid down in Article 10 (3) or 12 (6) of the said Directive, the restrictions applicable to the plants, plant products or other objects, and accordingly the territorial validity of the plant passport, or determine the replacement of the said plant passport, as well as the information to be filled in. If the producer, person or importer referred to in Article 2 (2) intends to dispatch a plant, plant product or other object into a protected zone referred to in Article 2 (1) (h) of the said Directive for which he does not have a valid plant passport, the said responsible official bodies shall take the necessary steps and determine accordingly whether the product is qualified for the relevant protected zone. The said responsible official bodies shall ensure that the producer, person or importer referred to in Article 2 (2) shall notify the abovementioned intention to them within a reasonable period of time prior to dispatch and shall apply simultaneously for the corresponding plant passport; (c) ensure that the information is filled in, either entirely in capital letters if the plant passport is pre-printed, or in capital letters or entirely in typescript in all other cases. The botanical name of the plants or plant products shall be indicated in Latin characters; uncertified alterations or erasures shall invalidate the said plant passport; (d) ensure that if a plant, plant product or other object has received the qualification by them for a specific protected zone(s), the code for the protected zone(s) shall be indicated on the plant passport, against the distinctive marking 'ZP' (zona protecta) indicating that the said plant passport covers a plant, plant product or other object qualified for a protected zone(s); (e) ensure that if a plant passport is to be delivered for a plant, plant product or other object originating outside the Community, the plant passport shall be used, with the indication of the name of the country of origin or, where appropriate, the consignor country on the said plant passport; (f) ensure that if a plant passport is to be replaced by another plant passport, the plant passport referred to in Article 1 (1) shall be used; the code for the originally registered producer or importer shall be indicated on the said plant passport, against the distinctive marking 'RP' ('replacement passport') indicating that the said plant passport replaces another plant passport; (g) depending on where the said plant passport is physically stored, either deliver the said plant passport, or authorize the producer, person or importer referred to in Article 2 (2) to use it accordingly; (h) ensure that the part of the said plant passport consisting of the label be attached under the responsibility of the producer, person or importer referred to in Article 2 (2), to the plants, plant products or other objects, to their packaging or to the vehicles transporting them in such a manner that it cannot be reused. Article 4 The system whereby the plant passport referred to in Article 1 (1) is used shall be reconsidered not later than 30 June 1994. The use of the plant passport referred to in Article 1 (2) (c) shall apply for a period expiring on 30 June 1993. Article 5 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive on the date referred to in Article 3 (1) of Council Directive 91/683/EEC (7). They shall forthwith inform the Commission thereof. 2. When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 3. Member States shall immediately communicate to the Commission all provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 6 This Directive is addressed to the Member States.

31992L0106

1992

Council Directive 92/106/EEC of 7 December 1992 on the establishment of common rules for certain types of combined transport of goods between Member States Having regard to the Treaty establishing the European Economic Community, and in particular Articles 75 and 84 (2) thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Council Directive 75/130/EEC of 17 February 1975 on the establishment of common rules for certain types of combined road/rail carriage of goods between Member States (4) has been amended several times; whereas on the occasion of further amendments the Directive should be recast in the interests of clarity; Whereas the internal market is leading to an increase in traffic; whereas the Community must do what is necessary to ensure optimum management of its transport resources in the interest of all citizens, which means using combined transport; Whereas the increasing problems relating to road congestion, the environment and road safety call, in the public interest, for the further development of combined transport as an alternative to road transport; Whereas measures must be taken to make possible the development and further improvement of transport methods based on the intermodality of forms of transport and on the specific means and requirements of transport operators and users; whereas such measures must cover combined forms of transport bringing together road and other modes of transport, such as rail, inland waterway and sea transport; Whereas greater recourse to combined transport will be encouraged by freedom from all quantitative restrictions and by the elimination of various administrative constraints which still exist in the field of road transport; Whereas for combined transport methods to result in a real reduction in road congestion, such liberalization should relate to road journeys of limited distance; Whereas the liberalization of the initial and final sections of a combined transport operation should be extended to combined transport operations using sea routes provided that the sea journey represents an important part of the combined transport operation; Whereas the Commission should submit a report every two years, starting before 1 July 1995, on the application of this Directive; Whereas the development of combined transport would also be facilitated by stimulation measures and whereas it is therefore appropriate to reduce taxation on the use or possession of commercial vehicles to the exent that they are carried by rail and to exempt initial and final road haulage legs from compulsory tariff regulations; Whereas access by own-account transport to combined transport should be facilitated; Whereas this Directive must not affect Member States' obligations regarding the time-limits for the transportation into national law and implementation of the Directives which make up the recast version, Article 1 1. This Directive shall apply to combined transport operations, without prejudice to Regulation (EEC) No 881/92 (5). For the purposes of this Directive, 'combined transport' means the transport of goods between Member States where the lorry, trailer, semi-trailer, with or without tractor unit, swap body or container of 20 feet or more uses the road on the initial or final leg of the journey and, on the other leg, rail or inland waterway or maritime services where this section exceeds 100 km as the crow flies and make the initial or final road transport leg of the journey; - between the point where the goods are loaded and the nearest suitable rail loading station for the initial leg, and between the nearest suitable rail unloading station and the point where the goods are unloaded for the final leg, or; - within a radius not exceeding 150 km as the crow flies from the inland waterway port or seaport of loading or unloading. Article 2 Each of the Member States shall, by 1 July 1993, liberalize the combined transport operations referred to in Article 1 from all quota systems and systems of authorization. Article 3 In the case of combined transport for hire or reward, a transport document which fulfils at least the requirements laid down in Article 6 of Council Regulation No 11 of 27 June 1960 concerning the abolition of discrimination in transport rates and conditions, in implementation of Article 79 (3) of the Treaty establishing the European Economic Community (6), shall also specify the rail loading and unloading stations relating to the rail leg, or the inland waterway loading and unloading ports relating to the inland waterway leg, or the maritime loading and unloading ports relating to the maritime section of the journey. These details shall be recorded before the transport operation is carried out and shall be confirmed by means of a stamp affixed by the rail or port authorities in the railway stations or inland waterway or sea ports concerned when that part of the journey carried out by rail or inland waterway or by sea has been completed. Article 4 All hauliers established in a Member State who meet the conditions of access to the occupation and access to the market for transport of goods between Member States shall have the right to carry out, in the context of a combined transport operation between Member States, initial and/or final road haulage legs which form an integral part of the combined transport operation and which may or may not include the crossing of a frontier. Article 5 1. Every two years and in the first instance by 1 July 1995 the Commission shall draw up a report to the Council on: - the economic development of combined transport, - the application of Community law in this area, - the definition, where necessary, of further measures to promote combined transport operations. 2. When drawing up the report referred to in paragraph 1, the Commission shall be assisted by representatives of the Member State to collect the information necessary for this purpose. The report shall analyze the information and statistics relating in particular to: - transport links used in combined transport operation, - the number of vehicles (a road train counting as a single vehicle), swap bodies and containers transported over the various transport links, - transported tonnages, - services carried out, in terms of tonnes/kilometres. The report shall, where appropriate, propose solutions for the subsequent improvement of such information and the situation in the combined transport sector. Article 6 1. Member States shall take the measures necessary to ensure that the taxes listed in paragraph 3 which are applicable to road vehicles (lorries, tractors, trailers or semi-trailers) when routed in combined transport are reduced or reimbursed either by a standard amount, or in proportion to the journeys that such vehicles undertake by rail, within limits and in accordance with conditions and rules they fix after consultation with the Commission. The reductions of reimbursements referred to in the first paragraph shall be granted by the State in which the vehicles are registered, on the basis of the rail journeys effected within that State. Member States may, however, grant these reductions or reimbursements on the basis of the rail journeys which take place partially or wholly outside the Member State in which the vehicles are registered. 2. Without prejudice to the provisions resulting from a possible reorganization of national taxation systems for commercial vehicles at Community level, vehicles used exclusively for road haulage in feeder or final delivery carriage by combined transport may be exempted, if they are taxed separately, from the taxes listed in paragraph 3. 3. The taxes referred to in paragraphs 1 and 2 are the following: - Belgium: taxe de circulation sur les véhicules automobiles/verkeersbelasting op de autovoertuigen; - Denmark: vaegtafgift af motorkoeretoejer mv.; - Germany: Kraftfahrzeugsteuer; - France: taxe spéciale sur certains véhicules routiers; - Greece: ôÝëç êõêëïoeïñssáò áõôïêéíÞôùí; - Spain: (a) impuesto sobre actividades económicas, (b) impuesto sobre vehículos de tracción mecánica; - Ireland: vehicle excise duties; - Italy: (a) tassa automobilistica, (b) addizionale del 5 % sulla tassa automobilistica; - Luxembourg: taxe sur les véhicules automoteurs; - Netherlands: motorrijtuigenbelasting; - Portugal: (a) imposto de camionagem, (b) imposto de circulaçao; - United Kingdom: vehicle excise duties. Article 7 Where a trailer or semi-trailer belonging to an undertaking engaged in own-account transport is hauled on a final section by a tractor belonging to an undertaking engaged in transport for hire or reward, the transport operation so effected shall be exempt from presentation of the document provided for in Article 3; however, another document shall be provided giving evidence of the journey covered or to be covered by rail, by inland waterway or by sea. Article 8 Initial or final road haulage legs forming part of combined transport operations shall be exempted from compulsory tariff regulations. Article 9 Where, as part of a combined transport operation, the dispatching undertaking carries out the initial road haulage leg for its own account within the meaning of the First Council Directive of 23 July 1962 on the establishment of common rules for certain types of carriage of goods by road (7), the undertaking which is to receive the goods transported may, notwithstanding the definition given in the said Directive, carry out for its own account the final road haulage leg to transport the goods to their destination using a tractor owned by it, bought by it on deferred terms or hired by it pursuant to Council Directive 84/647/EEC of 19 December 1984 on the use of vehicles hired without drivers for the carriage of goods by road (8), and driven by its employees, even though the trailer or semi-trailer is registered or hired by the undertaking which dispatched the goods. The initial road haulage leg in a combined transport operation which the dispatching undertaking carries out using a tractor owned by it, bought by it on deferred terms or hired by it pursuant to Directive 86/647/EEC and which is driven by its employees, whereas the trailer or semi-trailer is registered or hired by the undertaking which is to receive the goods transported, shall also, notwithstanding the Directive of 23 July 1962, be considered an own-account carriage operation if the final road haulage leg is carried out for its own account in accordance with the latter Directive by the recipient undertaking. Article 10 1. Member States shall bring into force the laws, regulations and administrative provisions necessary in order to comply with this Directive by 1 July 1993. They shall forthwith inform the Commission thereof. When these Member States adopt these provisions, they shall contain a reference to this Directive or 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 the main provisions of national law which they adopt in the field covered by this Directive to the Commission. Article 11 1. Directive 75/130/EEC (9) is hereby repealed without prejudice to the obligations of the Member States regarding the time-limits for transposition and implementation set out in the Annex, part A. 2. References to the repealed Directive shall be understood as references to this Directive and shall be read in accordance with the correlation table in the Annex, part B. Article 12 This Directive is addressed to the Member States.

31992L0107

1992

Commission Directive 92/107/EEC of 11 December 1992 amending Council Directive 69/208/EEC on the marketing of seed of oil and fibre plants Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 69/208/EEC of 30 June 1969 on the marketing of seed of oil and fibre plants (1), as last amended by Commission Directive 92/9/EEC (2), and in particular Article 20a thereof, Whereas in the light of the development of scientific and technical knowledge Annex II to Directive 69/208/EEC should be amended so as to improve the standards to be satisfied in respect of the minimum varietal purity by seed of soya bean; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry, Article 1 In Annex II (1) to Directive 69/208/EEC the figures '97' and '95' in column 2 ('Minimum varietal purity %') given respectively for basic seed and certified seed of Glycine max shall be replaced by the figures '99,5' and '99'. Article 2 Member States shall take the necessary measures to comply with this Directive by 1 July 1994. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

31992L0110

1992

Council Directive 92/110/EEC of 14 December 1992 amending Directive 88/657/EEC laying down the requirements for the production of, and trade in, minced meat, meat in pieces of less than 100 grams and meat preparations Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 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 minced meat, meat preparations and comminuted meat for industrial use are included in the list of products in Annex II to the Treaty; whereas the production of and trade in this minced meat, meat preparations and comminuted meat for industrial use constitute an important source of income for part of the farming population; Whereas in order to ensure the rational development of the industry producing such meat and to increase productivity, public health rules for the production and placing on the market of such meat must be laid down at Community level; Whereas the Community must adopt the measures with the aim of progressively establishing the internal market, comprising an area without internal frontiers, over a period expiring on 31 December 1992; Whereas the laying down of such public health rules improves the protection of public health and consequently facilitates the completion of internal market; Whereas, to achieve this purpose, it is necessary to extend the principal health rules laid down in Council Directive 88/657/EEC of 16 December 1988 laying down the requirements for the production of, and trade in, minced meat, meat in pieces of less than 100 grams and meat preparations and amending Directives 64/433/EEC, 71/118/EEC and 72/462/EEC (4) to all production and placing on the market of minced meat and meat preparations in the Community; Whereas the possibility for Member States to maintain provisionally less strict rules for meat and meat preparations reserved for the domestic market should not have an impact upon the abolition of veterinary checks at the Community's internal frontiers on 1 January 1993; Whereas pending the adoption of all the provisions necessary for the extension of the main health rules laid down in Directive 88/657/EEC to all production and placing on the market of minced meat and meat preparations in the Community, certain specific questions should be settled in order to avoid problems in the production and marketing of meat and meat preparations, Article 1 Directive 88/657/EEC is amended as follows: 1. the last phrase of Article 2 (2) (f) shall be replaced by the following: 'and any plant producing meat preparations fulfilling the requirements of Chapter I of Annexes A and B to Directive 77/99/EEC.` 2. Article 3 (1) (g) shall be replaced by the following: '(g) during transport to the country of destination they must be accompanied by a health certificate that satisfies the requirements in Chapter XII of Annex I to Directive 64/433/EEC or those in Chapter XI of Annex I to Directive 71/118/EEC (remainder unchanged)`; 3. the first subparagraph of Article 13 (1) shall be replaced by the following: '1. Member States may have a period of time expiring on 1 January 1996 within which to ensure that all meat and meat preparations referred to in Article 2 (2) and produced in their territory for marketing there satisfy, subject to the second subparagraph of this paragraph, the requirements of this Directive.`; 4. in Annex I, Chapter III, point 8, the second sentence shall be replaced by the following: 'In particular, it may not be prepared from meat from the following parts of bovine animals, pigs, sheep or goats: fragments of muscles from the head, the point at which the sticking of the animals took place, injection areas, bone scrapings, the diaphragm and the non-muscular part of the linea alba, carpus and tarsus region.`; 5. Annex I, Chapter IV, point 10 (b) shall be replaced by the following: '(b) meat preparations made from meat which has been minced as provided for in Article 2 (2) (c) may be marketed only on condition that: (i) they are frozen in accordance with the third indent of Article 3 (2) (c) at a freezing speed of at least 1 cm/H. The maximum shelf-life must not exceed six months; (ii) they are refrigerated at a maximum core temperature of +2° C, with a mention of the sell-by date. Meat preparations as defined in points (i) and (ii) must be packed in dispatch units.`; 6. in Annex I, Chapter VII, point 18, the second sentence shall be replaced by the following: 'Meat and meat preparations, as defined in Article 2 (2) of this Directive and produced in the establishments referred to in the said Article 2 (2) (g) must be marked on the packaging with the health mark of the establishment as defined in Annex X to Directive 64/493/EEC and in Chapter VIII of Annex A to Directive 77/99/EEC.` Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1993 as regards point 3, and by 1 December 1993 as regards points 1, 2, 4, 5 and 6. 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 texts of the provisions of domestic law which they adopt in the field governed by this Directive. Article 3 This Directive is addressed to the Member States.

31992L0109

1992

Council Directive 92/109/EEC of 14 December 1992 on the manufacture and the placing on the market of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances 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 some Member States have adopted measures to monitor the manufacture and the placing on the market of certain substances frequently used in the illicit manufacture of narcotic drugs and psychotropic substances; whereas other Member States are about to adopt measures of this kind; whereas it is therefore necessary to establish commun rules at Community level in anticipation of the completed internal market in order to avoid distortion of competition in lawful trading and to ensure uniform application of the rules adopted; Whereas on 19 December 1988 a Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, hereinafter referred to as the 'United Nations Convention`, was adopted in Vienna; whereas the United Nations Convention is part of the world-wide efforts to combat drugs; whereas the Community participated in the negotiation of that Convention, showing its political will to act within the limits of its competences; Whereas the requirements of Article 12 of the United Nations Convention, in respect of trade in precursors, (i.e. substances frequently used in the illicit manufacture of narcotic drugs or psychotropic substances, are implemented as far as trade between the Community and third countries is concerned by Council Regulation (EEC) No 3677/90 of 13 December 1990 laying down measures to be taken to discourage the diversion of certain substances to the illicit manufacture of narcotic drugs and psychotropic substances (4); Whereas Article 12 of the United Nations Convention envisages adoption of appropriate measures to monitor manufacture and distribution of precursors; whereas, by decisions taken at its 35th session, the United Nations Commission on Narcotic Drugs included additional substances in the tables of the Annex to the Convention; whereas corresponding provisions should be laid down in this Directive in order to detect possible cases of illicit diversion of drugs in the Community or to counter fraudulent imports into the Community and to ensure that common monitoring rules are applied in the Community market; Whereas the provisions of Article 12 of the United Nations Convention are based on a system of monitoring trade in the substances in question; whereas most trade in these substances is fully licit; whereas the documentation and labelling of consignments of these substances must be sufficiently explicit; whereas it is furthermore important, whilst providing competent authorities with the necessary means of action, to develop within the spirit of the United Nations Convention mechanisms based on close cooperation with the operators concerned and on the development of intelligence gathering, exchange and exploitation; Whereas, since diversion patterns are constantly changing, it is considered at international level that the procedures provided for in Article 12 of the United Nationsl Convention should be strenghtened to combat effectively the diversion of the substances concerned; Whereas the Commission and seven Member States participated in the work of the Chemical Action Task Force established by the G7 Economic Summit in Houston on 10 July 1990 to develop effective procedures to prevent diversion of precursor and essential chemicals to illicit drugs manufacture; whereas throughout this work there has been coordination at Community level and close consultation with representatives of trade and industry; Whereas the Final Report of the Chemical Action Task Force was approved by the G7 Economic Summit in London on 15 July 1991; Whereas this Final Report, in recognizing the United Nations Convention as the basic instrument of internation cooperation in chemical diversion matters, contains a number of recommendations for reinforcing national and international measures on the basis of that Convention; Whereas it must be ensured that the manufacture or use of the scheduled substances in category 1 of Annex I to this Directive is subject to possession of a licence; whereas the supply of such substances must in addition be authorized only where the persons to whom they are to be supplied are specifically authorized, either generally or individually, to be supplied with, possess or handle such substances; Whereas measures should be adopted to establish close cooperation with the operators concerned so that the latter notify suspicious transactions to the competent authorities; Whereas it is important to establish machinery for administrative cooperation; whereas it is desirable in this connection that the competent authorities in the Community base their actions on Council Regulation (EEC) No 1468/81 of 19 May 1981 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs and agricultural matters (5); whereas particular attention must be paid to the confidentiality of the information received and exchanged; Whereas each Member State should introduce penalties sufficiently dissuasive to forestall infringements of the provisions adopted in implementation of this Directive, TITLE I General Article 1 1. The purpose of this Directive is to establish intra-Community monitoring of certain substances frequently used for the illicit manufacture of narcotic drugs and psychotropic substances with a view to preventing the diversion of such substances. 2. For the purposes of this Directive: (a) 'scheduled substance` means any substance specified in Annex I, including mixtures containing such substances. This excludes medicinal products or other preparations containing scheduled substances that are compounded in such a way that such substances cannot be easily used or recovered by readily applicable means; (b) 'placing on the market` means any supply against payment or free of charge to third parties of scheduled substances manufactured in the Community or put into free circulation in the Community; (c) 'operator` means any natural or legal person engaged in the manufacture, processing, trade or distribution of scheduled substances in the Community or involved in other related activities such as the brokering and storage of scheduled substances; (d) 'International Narcotics Control Board` means the Board established by the Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol. TITLE II MONITORING OF PLACING ON THE MARKET Article 2 Documentation and labelling Each Member State shall take all the measures necessary to ensure that the placing on the market of scheduled substances is subject to the following requirements: 1. all transactions leading to the placing on the market of scheduled substances in categories 1 and 2 of Annex I shall be properly documented; (a) in particular, commercial documents such as invoices, cargo manifests, administrative documents, transport and other shipping documents shall certain sufficient information positively to identify: - the name of the scheduled substance as given in categories 1 and 2 of Annex I, - the quantity and weight of the scheduled substance and, where it consists of a mixture, the quantity and weight of the mixture as well as the quantity and weight or the percentage of any substance or substances specified in categories 1 and 2 of Annex I which are contained in the mixture, - the name and address of the supplier, distributor and of the consignee; (b) the documentation must furthermore contain a declaration from the customer which shows the specific uses of the substances. The detailed rules for implementing this provision will be determined in accordance with the procedure laid down in Article 10 (2). When these detailed rules are examined, due account shall be taken of the possibility for a regular customer obtaining from a supplier a scheduled substance specified in category 2 of Annex I to provide a single declaration covering all transactions involving that substance over a period of one year; 2. however, the obligations under paragraph 1 shall not apply to transactions concerning scheduled substances in category 2 of Annex I where the quantities involved do not exceed those indicated in Annex II; 3. operators shall ensure that labels are affixed to scheduled substances in categories 1 and 2 of Annex I before they are placed on the market. Such labels must show the names of the substances as given in Annex I. Operators may in addition affix their customary labels; 4. operators shall keep such detailed records of their activities as are required to comply with their obligations under paragraph 1; 5. the documentation referred to in paragraphs 1 and 4 shall be kept for a period of not less than three years from the end of the calendar year in which the operation referred to in paragraph 1 took place, and must be readily available for inspection by the competent authorities upon request. Article 3 Each Member State shall designate the competent authority or authorities responsible for ensuring the application of this Directive. It shall inform the Commission of the competent authority or authorities thus designated. Article 4 Scheduled substances in Categories 1 and 2 of Annex I 1. Member States shall take all appropriate measures to ensure that the manufacture or placing on the market in the Community of scheduled substances in category 1 of Annex I is subject to possession of a licence issued by the competent authorities. 2. In considering whether to grant a licence, the competent authorities shall take into account in particular the competence and integrity of the applicant. The licence may be suspended or revoked by the competent authorities whenever there are reasonable grounds for belief that the holder is no longer a fit and proper person to hold a licence, or that the conditions under which the licence was issued are no longer fulfilled. 3. Member States shall take all appropriate measures to ensure that any operator holding the licence referred to in paragraph 1 shall supply scheduled substances specified in category 1 of Annex I only to persons specifically authorized, either generally or individually, to be supplied with, possess or handle such substances. 4. Operators engaged in the manufacture or placing on the market of scheduled substances in category 2 of Annex I shall be required to register and update with the competent authorities the addresses of the premises from which they manufacture or trade in these substances. Article 5 Cooperation Member States shall take the necessary measures to establish close cooperation between the competent authorities and operators, so that operators: - notify the competent authorities immediately of any circumstances, such as unusual orders or transactions involving scheduled substances, which suggest that such substances to be placed on the market or manufactured, as the case may be, may be diverted for the illicit manufacture of narcotic drugs or psychotropic substances, - provide the competent authorities in summary form with such information about their transactions involving scheduled substances as the competent authorities may require. TITLE III CONTROL MEASURES Article 6 Powers of competent authorities 1. In order to ensure the correct application of Articles 2 and 4, each Member State shall adopt, within the framework of its national law, the measures necessary to enable the competent authorities: (a) to obtain information on any orders for scheduled substances or operations involving scheduled substances; (b) to enter operators' business premises in order to obtain evidence of irregularities. TITLE IV ADMINISTRATIVE COOPERATION Article 7 For the purposes of applying this Directive and without prejudice to Article 10, the provisions of Regulation (EEC) No 1468/81 and in particular those on confidentiality shall apply mutatis mutandis. Each Member State shall communicate to the other Member States and to the Commission the names of the competent authorities appointed to act as correspondents in accordance with Article 2 (2) of that Regulation. TITLE V FINAL PROVISIONS Article 8 Each Member State shall determine the penalties to be applied for infringement of the provisions adopted in implementation of this Directive. The penalties shall be sufficient to promote compliance with those provisions. Article 9 1. To permit any necessary adjustments to the arrangements for monitoring scheduled substances, the competent authorities in each Member State shall each year communicate to the Commission all relevant information on the implementation of the monitoring measures laid down in this Directive, in particular as regards substances used for the illicit manufacture of narcotic drugs or psychotropic substances and methods of diversion and illicit manufacture. 2. On the basis of the communications made pursuant to paragraph 1, the Commission shall, in accordance with Article 12 (12) of the United Nations Convention and in consultation with the Member States, draw up an annual report to be submitted to the International Narcotics Control Board. Article 10 1. The Commission shall be assisted by the Committee set up pursuant to Article 10 of Regulation (EEC) No 3677/90. The Committee shall examine any matter concerning the application of this Directive raised 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 deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote. The Commission shall adopt measures which shall apply immediately. However, if these measures are not in accordance with the opinion of the Committee, they shall be communicated by the Commission to the Council forthwith. In that event the Commission shall defer application of the measures which it has decided for three months from the date of communication. The Council, acting by a qualified majority, may take a different decision within the period referred to in the previous subparagraph. 3. The procedure laid down in paragraph 2 shall be followed in particular for: (a) the determination, where appropriate, of the conditions relating to the documentation and labelling of mixtures and preparations of substances in category 2 of Annex I as provided for in Article 2; (b) the amendment of the Annexes to this Directive, in cases where the tables of the Annex to the United Nations Convention are amended; (c) the amendment of the thresholds specified in Annex II. Article 11 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Articles 7 and 10 before 1 January 1993 and with the other Articles before 1 July 1993. 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 determined by the Member States. 2. Member States shall communicate to the Commission the main provisions of national law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 12 This Directive is addressed to the Member States.

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Commission Directive 92/113/EEC of 16 December 1992 amending Council Directive 70/524/EEC concerning additives in feedingstuffs Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Commission Directive 92/99/EEC (2), and in particular Article 7 thereof, Whereas Directive 70/524/EEC provides for regular amendment of the content of its Annexes to take account of advances in scientific and technical knowledge; whereas the Annexes have been codified by Commission Directive 91/248/EEC (3); Whereas the use of the preservative methylpropionic acid has been widely tested in certain Member States; whereas, on the basis of experience gained, it appears that this new use can be authorized throughout the Community; Whereas it is advisable to provide specific provisions concerning the addition of iodine in feedingstuffs in order to prevent unfavourable effects for certain species; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs, Article 1 Annex I to Directive 70/524/EEC is hereby amended as set out in the Annex hereto. Article 2 Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 30 June 1993 at the latest. They shall immediately inform the Commission thereof. When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

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Council Directive 92/117/EEC of 17 December 1992 concerning measures for protection against specified zoonoses and specified zoonotic agents in animals and products of animal origin in order to prevent outbreaks of food-borne infections and intoxications Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 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 live animals and products of animal origin appear on the list in Annex II to the Treaty; whereas livestock farming and the placing on the market of products of animal origin constitute an important source of income for the farming population; Whereas the rational development of this sector and an improvement in its productivity may be achieved by the implementation of veterinary measures aimed at protecting and raising the level of public and animal health in the Community; Whereas it is necessary to prevent and reduce, by appropriate measures, the appearance of zoonoses which pose a threat to human health in particular, through food of animal origin; Whereas the Community has already undertaken action for the eradication of certain zoonotic diseases and in particular bovine tuberculosis, bovine brucellosis, brucellosis in sheep and goats, and rabies; whereas it is advisable to collect epidemiological information on those diseases; Whereas those measures should apply without prejudice to Council Directive 89/397/EEC of 14 June 1989 on the official control of foodstuffs (4); Whereas, in order to assess the priorities for preventive action, it is necessary to collect information in the Member States on the incidence of zoonotic diseases in the human population, in domestic animals, in animal feedingstuffs and wildlife; Whereas the Commission should follow the development of the epidemiological situation so as to propose the appropriate measures; Whereas the situation with respect to salmonellosis justifies the adoption of immediate control measures for certain types of farming at risk; Whereas the harmonization of the essential requirements concerning the protection of public health presupposes prior designation of Community liaison and reference laboratories and the implementation of technical and scientific actions; Whereas detailed rules governing the Community's financial contribution towards certain actions laid down in this Directive have been laid down by Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (5); Whereas it is appropriate to make provision for a procedure establishing close effective cooperation between the Member States and the Commission for the adoption of implementing measures, Article 1 This Directive lays down rules for the collection of information on zoonoses and zoonotic agents and the relevant measures to be taken in the Member States and at Community level. Article 2 For the purposes of this Directive: 1. zoonosis means any disease and/or infection which is likely to be naturally transmitted from animals to man; 2. zoonotic agent means any bacterium, virus or parasite which is likely to cause a zoonosis; 3. approved national laboratory means a laboratory approved or recognized by the competent authority of a Member State to carry out examinations of official samples in order to detect a zoonotic agent; 4. sample means a sample taken by the owner of or person responsible for the establishment or the animals, or taken on his behalf, to be examined for a zoonotic agent; 5. official sample means a sample taken by the competent authority to test for a zoonotic agent. The official sample bears a reference to the species, the type, the amount and the method of collection, and the identification of the origin of the animal or the product of animal origin; this sample is to be taken without prior warning; 6. competent authority means the central authority or authorities of a Member State which is/are responsible for monitoring provisions concerning public health, animal health or other veterinary matters arising from this Directive, or any other authority to which such responsibility has been delegated by the central authority. Article 3 1. Each Member State shall ensure that measures taken in accordance with this Directive by the competent authority are coordinated at national and local level, in particular in relation to epidemiological surveys. 2. The competent authority at local level shall be assisted by approved national laboratories. 3. Each Member State shall designate the approved national reference laboratories for the zoonoses and zoonotic agents listed in Annex I, point I, at which the identification of a zoonotic agent or final confirmation of its presence may be carried out. Article 4 1. Member States shall ensure that: (a) the operators or managers of establishments approved in accordance with Directives 64/433/EEC (6), 71/118/EEC (7) and 77/99/EEC (8) are obliged to keep for a minimum period to be specified by the competent authority and to communicate to the latter at its request, the results of examinations for the presence of the zoonoses listed in Annex I, point I; (b) the isolation and identification of zoonotic agents or the establishment of any other evidence of their presence rests with the person responsible for the laboratory or, where the identification is carried out elsewhere than at a laboratory, with the person responsible for the examination; (c) the diagnosis and identification of a zoonotic agent are reported to the competent authority; (d) the competent authority collects information on any zoonotic agents the presence of which has been confirmed in the course of the tests or examinations carried out and on any clinical cases in humans or animals of the zoonoses listed in Annex I, point I; (e) the other Member States are regularly informed within the Standing Veterinary Committee set up by Decision 68/361/EEC (9) of clinical cases recorded in accordance with (d). 2. In accordance with the procedure laid down in Article 16, the provisions of this Article may be extended to cover the zoonoses and zoonotic agents listed in Annex I, points II and III. Article 5 1. The competent authority shall evaluate the information collected in accordance with Article 4 (1) (d). It shall report to the Commission, by 31 March each year, the trends and sources of the zoonotic infections recorded during the previous year. 2. Paragraph 1 shall not rule out more frequent reporting to the Commission by Member States, or requests from the Commission for additional information, where the circumstances warrant. The Commission shall evaluate the information supplied by Member States and shall report to the Standing Veterinary Committee before 1 October each year. 3. The Commission shall, before 1 January 1996, submit a report to the Council on experience acquired, accompanied by proposals to improve the reporting system, on which the Council will take a decision by a qualified majority. Article 6 The Commission shall follow the development of the situation in relation to zoonoses in the Community, particularly on the basis of the information collected pursuant to Articles 5 and 8, and: (a) shall conduct specific studies, in particular in relation to the evaluation of risks from zoonotic agents, diagnostic procedures and control measures, in collaboration with the competent national laboratories, the Community reference laboratories referred to in Article 13 and the Scientific Veterinary Committee set up by Decision 81/651/EEC (10); (b) shall, in accordance with the procedure laid down in Article 16, establish the methods of collecting samples and carrying out examinations in the national laboratories referred to in Article 3 (2) and (3). In the case of salmonella this shall be done before the date laid down in Article 17; (c) shall establish guidelines for measures to combat zoonoses. Article 7 The systems for tracing the movement of farm animals laid down in Commission Decision 89/153/EEC (11) shall be enforced in relation to the measures for zoonoses and zoonotic agents laid down in this Directive. Article 8 1. Member States shall submit to the Commission before 1 October 1993 the national measures which they are taking to achieve the objectives of this Directive in respect of the zoonoses listed in Annex I, points I and II, with the exception of those already being taken for brucellosis and tuberculosis under plans already approved within the framework of Community legislation. They may include measures to detect the zoonoses and zoonotic agents listed in Annex I, point III. Member States which have national plans for the detection of the zoonoses listed in Annex I, point II, may submit them to the Commission as the information required in accordance with the first subparagraph. Member States shall forward to the Commission, every year, a report on the epidemiological situation for trichinosis. The Commission shall examine the measures communicated by the Member States to determine whether they are compatible with the objectives of this Directive. It shall inform the Member States, meeting in the Standing Veterinary Committee, of its conclusions. 2. In the case of salmonella in fowls, Member States must forward to the Commission before 1 January 1994 plans drawn up in accordance with the criteria laid down in Annexes II and III. These plans must: (a) specify as regards salmonella the measures taken to comply with the minimum requirements laid down in Annex III; (b) take into account the specific situation in each Member State; (c) indicate the number of approved national laboratories at which examination and identification of salmonella will take place and the approval procedures for those laboratories. 3. In accordance with the procedure laid down in Article 16: - the plans referred to in paragraph 2, amended if necessary, shall be approved not later than six months after their submission, - amendments or additions may be made to a plan previously approved in order to take account of developments in the situation in the Member State concerned or in one of its regions. Article 9 1. Detailed rules governing the Community's financial contribution towards the measures for slaughter and destruction and official sampling imposed pursuant to Annex III, Section I, point V and towards the operation of the laboratories listed in Annex IV shall be laid down in accordance with Decision 90/424/EEC. As regards the measures provided for in Annex III, the financial contribution provided for in Decision 90/424/EEC must not benefit breeders who have contravened the requirements of this Directive. 50 % of the cost of applying the slaughter and destruction measures referred to in the first subparagraph shall be met from the aforementioned Community financial contribution. 2. In Article 4 of Decision 90/424/EEC the following paragraph 3 shall be added: '3. The provisions of Article 3, with the exception of the fourth indent of paragraph 2 and the second indent of paragraph 5, shall apply when a zoonosis listed in Directive 92/117/EEC occurs, provided that this occurrence is an immediate risk to human health. This condition will be fulfilled when the decision provided for in Article 3 (3) is taken.' Article 10 1. Member States shall implement as from 1 January 1994 the minimum measures laid down for salmonella in Annex III, Section I. Member States must, before 1 January 1994, establish rules specifying the measures to be taken to avoid the introduction of salmonella onto a farm, taking account of the principles set out in Annex II to Directive 90/539/EEC. The Council, acting by a qualified majority before 1 January 1995 on a proposal from the Commission drawn up in the light of an opinion from the Scientific Veterinary Committee and on the basis of experience gained at the time this Directive was implemented, shall decide on the measures required to control salmonella in flocks of layers. Pending the adoption of such measures, Member States may, with due regard for the rules of the Treaty, maintain their national rules in respect of layers. 2. The Council, acting by a qualified majority on a proposal drawn up by the Commission on the basis of the information gathered in accordance with Articles 5 and 6 and Article 8 (1), shall decide whether specific measures to control other zoonoses of comparable seriousness are needed. Article 11 1. Experts from the Commission may, in so far as is necessary for the uniform application of this Directive and in cooperation with the competent authorities of the Member States, make on-the-spot checks. To do this, they may verify by checking a representative percentage of holdings whether the Member States are ensuring compliance with this Directive. The Commission shall inform the competent authority of the results of the checks made. The Member State concerned shall take any measures which may prove necessary to take account of the results of the checks. If the Member State does not take such measures, after the situation has been examined by the Standing Veterinary Committee appropriate measures may be decided on under the procedure laid dow in Article 16. 2. The detailed rules for implementing this Article, especially as regards the frequency and method of carrying out the checks referred to in the first subparagraph of paragraph 1, shall be adopted under the procedure set out in Article 16. Article 12 The safeguard measures provided for in Directive 90/425/EEC (12) concerning veterinary checks to be carried out in trade with a view to the completion of the internal market shall apply for the purposes of this Directive. Article 13 The Community reference laboratories listed in Annex IV shall, in accordance with the tasks and duties described therein, be responsible, for liaison with and coordination of the national reference laboratories referred to in Article 3 (3). Article 14 1. Admission to, or retention on, the Community list of third countries or parts thereof from which imports are authorized in health terms shall be subject to the submission, by the third country concerned, of a plan giving details of the guarantees afforded by that country as regards inspections for zoonoses and zoonotic agents. The effect of these guarantees must be no less than that resulting from the guarantees provided for by this Directive. The Commission shall approve the plans in question in accordance with the procedure provided for in Article 16. Alternative guarantees to those resulting from the application of this Directive may be allowed in accordance with that procedure, provided that they are not more favourable than those applicable to trade. 2. Where no decision pursuant to paragraph 1 has been taken with regard to a given third country by 31 December 1995, entry of that country on the list referred to in paragraph 1 shall be suspended in accordance with the procedure provided for in Article 16. 3. Compliance by the competent authorities of third countries with the execution of the plans shall be verified when the Community experts carry out the checks provided for in Community rules. Article 15 The Annexes may be amended or supplemented by the Council, acting by a qualified majority on a proposal from the Commission. In particular, Annex III shall be reviewed under this procedure before 1 January 1996. Article 16 1. Where the procedure laid down in this Article is to be followed, matters shall be referred without delay to the Committee by its chairman, either on his own initiative or at the request of a Member State. 2. Within the Committee the votes of the Member States shall be weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote. 3. The Commission representative shall submit a draft of the measures to be taken. The Committee shall deliver its opinion on those measures within a time limit which the chairman may set according to the urgency of the matter submitted. Opinions shall be delivered by a majority of 54 votes. 4. (a) The Commission shall adopt the measures and implement them immediately where they are in accordance with the opinion of the Committee. (b) Where they are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall forthwith submit to the Council a proposal concerning the measures to be taken. The Council shall adopt the measures by a qualified majority. If, three months after the proposals were submitted to it, the Council has not adopted any measures, the Commission shall adopt the measures proposed and implement them immediately unless the Council has rejected those measures by a simple majority. Article 17 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1994. 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 texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 18 This Directive is addressed to the Member States.

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Council Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 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 live animals are listed in Annex II to the Treaty; whereas the marketing of live animals constitutes an important source of revenue for the agricultural population; Whereas it is necessary to establish at Community level the control measures to be taken in the event of outbreaks of disease, in order to ensure rational development of the farming sector and to contribute to the protection of animal health in the Community; Whereas an outbreak of disease can quickly take on epizootic proportions, causing mortality and disturbances which may severely compromise the profitability of stock farming; Whereas control measures must be taken as soon as the presence of a disease is suspected so that immediate and effective action can be implemented as soon as its presence is confirmed; Whereas the measures to be taken must allow the spread of the disease to be prevented, in particular by carefully controlling movements of animals and products liable to spread the infection; Whereas the prevention of diseases in the Community should normally be based on a non-vaccination policy; whereas, however, it is important to make provision for vaccination where a serious situation demands such action; Whereas in order to ensure that all vaccinated animals are recognizable, it is necessary for these animals to be identified; whereas in order to give the necessary guarantees, the potency of the vaccine must be approved by a reference laboratory designated by the Community; Whereas a thorough epidemiological enquiry is essential to prevent any spread of diseases; whereas the Member States must establish special units for this purpose; Whereas in order to ensure the effectiveness of the system of control, diagnosis of the diseases must be harmonized and must be carried out under the auspices of responsible laboratories, the coordination of which may be carried out by a reference laboratory designated by the Community; Whereas Article 3 of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (4) applies in the event of an outbreak of one of the diseases listed in Annex I; Whereas common measures for the control of these diseases form a basis for maintaining a uniform standard of animal health; Whereas specific provisions should also be laid down for each individual disease and, initially, for swine vesicular disease, Article 1 This Directive defines the general Community control measures to be applied in the event of an outbreak of one of the diseases listed in Annex I. Article 2 For the purposes of this Directive, the following definitions shall apply: 1. holding: any establishment (agricultural or other), situated in the territory of a Member State, in which animals are kept or bred; 2. animal: any domestic animal of a species liable to be directly affected by the disease in question, or any wild vertebrate animal likely to participate in the epidemiology of the disease, by acting as a carrier or reservoir of infection; 3. vector: any wild vertebrate or invertebrate animal which, by mechanical or biological means, is liable to transmit and spread the agent of the disease in question; 4. owner or keeper: any person or persons, either natural or legal, having ownership of the animals, or charged with keeping the said animals, whether or not for financial reward; 5. incubation period: the period of time likely to elapse between exposure to the agent of the disease and the onset of clinical symptoms. The duration of this period shall be that indicated in Annex I for the disease in question; 6. confirmation of infection: the declaration by the competent authority of the presence of any of the diseases listed in Annex I based on laboratory results; however, in the event of an epidemic, the competent authority may also confirm the presence of the disease on the basis of clinical and/or epidemiological results; 7. competent authority: the central authority of a Member State responsible for carrying out veterinary checks or any veterinary authority to which it has delegated that responsibility; 8. official veterinarian: the veterinarian appointed by the competent authority. Article 3 Member States shall ensure that it is compulsory for the suspected presence of any of the diseases referred to in Annex I to be notified immediately to the competent authority. Article 4 1. When animals on a holding are suspected of being infected or contaminated with one of the diseases listed in Annex I, Member States shall ensure that the official veterinarian immediately activates official investigation arrangements to confirm or rule out the presence of the disease in question and, in particular, must take or have taken the samples necessary for laboratory examination. To that end the animals in question may be transported to the laboratories under the supervision of the competent authority, which shall take appropriate steps to prevent the disease from spreading. 2. As soon as the suspected presence of the disease is notified, the competent authority shall have the holding placed under official surveillance and shall in particular require that: (a) a census be made of all categories of animals of susceptible species and that, in respect of each of these categories, the number of animals already dead, infected or liable to be infected or contaminated be recorded; the census must be kept up to date to take account of animals born or dying during the period of suspicion; the information in the census must be kept up to date and produced on request and may be checked at each visit; (b) all animals of susceptible species on the holding be kept in their living quarters or confined in some other place where they can be isolated taking into account the possible role of vectors, where appropriate; (c) no animals of susceptible species enter or leave the holding; (d) all movement: - of persons, animals of other species not susceptible to the disease and vehicles to or from the holding, - of meat or animal carcases, or of animal feed, equipment, waste, droppings, litter, manure, or anything liable to transmit the disease in question (e) be subject to authorization by the competent authority, which shall lay down the conditions for preventing any risk of the disease spreeding; appropriate means of disinfection be installed at the entrances and exits of buildings or places housing animals of susceptible species and of the holding itself; (f) an epizootiological inquiry be carried out in accordance with Article 8. 3. Until such time as the official measures laid down in paragraph 2 are enforced, the owner or keeper of any animal in which disease is suspected shall take every appropriate measure to ensure compliance with paragraph 2, except for subparagraph (f) thereof. 4. The competent authority may apply any of the measures provided for in paragraph 2 to other holdings should their location, their configuration or contacts with the holding where the disease is suspected give reason to suspect possible contamination. 5. The measures referred to in paragraphs 1 and 2 shall not be withdrawn until the suspicion of the presence of the disease has been ruled out by the official veterinarian. Article 5 1. Once it has been officially confirmed that one of the diseases listed in Annex I is present on a holding, Member States shall ensure that, in addition to the measures laid down in Article 4 (2), the competent authority requires application of the following measures: (a) all animals of susceptible species on the holding shall be killed on the spot, without delay. The animals which have died or been killed shall either be burnt or buried on the spot, if possible, or destroyed in a carcase disposal plant. These operations shall be carried out in such a way as to minimize the risk of disseminating the agent of the disease; (b) any substance or waste, such as animal feed, litter, manure or slurry, which is liable to be contaminated, shall be destroyed or treated appropriately. This treatment, carried out in accordance with the instructions of the official veterinarian, must ensure that any agent or vector of the agent of the disease is destroyed; (c) after carrying out operations listed in subparagraphs (a) and (b), the buildings used for housing animals of susceptible species, their surroundings, the vehicles used for transport and all equipment liable to be contaminated shall be cleaned and disinfected in accordance with Article 16; (d) an epizootiological inquiry shall be carried out in accordance with Article 8. 2. When recourse is had to burial, it must be deep enough to prevent carnivorous animals from digging up the carcases or waste referred to in paragraph 1 (a) and (b) above and must be in suitable ground so as to prevent contamination of water tables or any environmental nuisance. 3. The competent authority may extend the measures provided for in paragraph 1 to other neighbouring holdings should their location, their configuration or contacts with the holding where the presence of the disease has been confirmed give reason to suspect possible contamination. 4. The restocking of the holding shall be authorized by the competent authority, following the satisfactory inspection by the official veterinarian of the cleaning and disinfection operations carried out in accordance with Article 16. Article 6 Where animals living in the wild are infected or suspected of being infected, Member States shall ensure that appropriate action is taken. Member States shall inform the Commission and the other Member States, in the Standing Veterinary Committee set up by Decision 68/361/EEC (5), of the measures they have taken. Article 7 1. In the case of holdings which consist of two or more separate production units, the competent authority may derogate from the requirements of Article 5 (1) (a) as regards healthy production units of a holding which is infected, provided that the official veterinarian has confirmed that the structure and size of these units and the operations carried out therein are such that they are completely separate as regards housing, keeping, staff, equipment and feeding, so as to prevent the spread of the agent of the disease from one unit to another. 2. Where recourse is had to paragraph 1, the rules laid down in Commission Decision 88/397/EEC (6) shall apply mutatis mutandis. These rules may be amended for the disease in question under the procedure laid down in Article 25 in order to take account of the specific nature of the disease. Article 8 1. The epizootiological enquiry shall deal with: (a) the length of time during which the disease may have existed on the holding before being notified or suspected; (b) the possible origin of the disease on the holding and the identification of other holdings on which there are animals of susceptible species which may have become infected or contaminated; (c) the movement of persons, animals, carcases, vehicles, equipment or any other substances likely to have carried the agent of the disease to or from the holdings in question; (d) the presence and distribution of disease vectors as appropriate. 2. A crisis unit shall be established in order to provide full coordination of all measures necessary to ensure eradication of the disease as quickly as possible and for the purpose of carrying out the epizootiological enquiry. The general rules concerning national crisis units and the Community crisis unit shall be laid down by the Council, acting by a qualified majority on a proposal from the Commission. Article 9 1. Where the official veterinarian finds, or considers on the basis of confirmed data, that disease could have been introduced from other holdings onto the holding referred to in Article 4 or from the latter onto other holdings as a result of the movement of persons, animals or vehicles or in any other way, those other holdings shall be placed under official surveillance in accordance with Article 4; this surveillance shall not be lifted until the suspected presence of disease on the holding has been officially ruled out. 2. Where the official veterinarian finds, or considers on the basis of confirmed data, that disease could have been introduced from other holdings on to the holding referred to in Article 5 or from the latter onto other holdings as a result of the movement of persons, animals or vehicles or in any other way, those other holdings shall be placed under official surveillance in accordance with Article 4; this surveillance shall not be lifted until the suspected presence of disease on the holding has been officially ruled out. 3. When a holding has been subject to the provisions of paragraph 2, the competent authority shall keep the provisions of Article 4 in force on the holding for at least the maximum incubation period pertaining to each disease following the likely time of introduction of infection as established by the epizootiological enquiry carried out in accordance with Article 8. 4. Where it considers that conditions permit, the competent authority may limit the measures provided for in paragraphs 1 and 2 to a part of the holding and the animals contained therein provided that the holding can satisfy the conditions set out in Article 7, or to animals of susceptible species only. Article 10 1. Once the diagnosis of one of the diseases in question has been officially confirmed, Member States shall ensure that the competent authority establishes around the infected holding a protection zone with a minimum radius of three kilometres, itself contained in a surveillance zone with a minimum radius of 10 kilometres. The establishment of the zones must take account of geographical, administrative, ecological and epizootiological factors relating to the disease in question, and of monitoring facilities. 2. Where the zones are situated in the territory of more than one Member State, the competent authorities of the Member States concerned shall cooperate in establishing the zones referred to in paragraph 1. However, if necessary, the protection zone and the surveillance zone shall be established under the procedure provided for in Article 26. 3. At the duly substantiated request of a Member State or on the Commission's initiative, it may be decided under the procedure laid down in Article 26, to modify (in particular to reduce or increase, as appropriate) the boundaries of the zones laid down in paragraph 1 or the duration of the restriction measures, taking into account: - their geographical situation and ecological factors, - the meteorological conditions, - the presence, distribution and type of vectors, - the results of the epizootiological studies carried out in accordance with Article 8, - the results of laboratory tests, - control measures actually applied. Article 11 1. Member States shall ensure that the following measures are applied in the protection zone: (a) all holdings within the zone having animals of susceptible species shall be identified; (b) there shall be periodic visits to holdings having animals of susceptible species, a clinical examination of those animals including, if necessary, the collection of samples for laboratory examination; a record of visits and findings must be kept, with the frequency of visits being proportional to the seriousness of the epizootic on those holdings at greatest risk; (c) the movement and transport of animals of susceptible species on public or private roads, excluding the service roads of holdings, shall be prohibited; the competent authority may, however, grant a derogation from that prohibition for the transit of animals by road or rail without unloading or stopping; (d) animals of susceptible species must remain on the holding on which they are being kept, except to be transported under official supervision directly to a slaughterhouse located in that zone for emergency slaughter or, if that zone has no slaughterhouse under veterinary supervision, to a slaughterhouse in the surveillance zone designated by the competent authority. Such transport may be authorized by the competent authority only after the official veterinarian has carried out an examination of all the animals of susceptible species on the holding and confirmed that none of the animals is suspected of being infected. The competent authority responsible for the slaughterhouse shall be informed of the intention to send animals to it. 2. The measures applied in the protection zone shall be kept in force for at least the maximum incubation period pertaining to the disease in question after animals from the infected holding have been disposed of in accordance with Article 5 and cleaning and disinfection operations have been carried out in accordance with Article 16. However, where the disease is transmitted by an insect vector, the competent authority may fix the duration of the measures and lay down provisions for the possible introduction of sentinel animals. Member States shall forthwith inform the Commission and the other Member States, within the Standing Veterinary Committee, of the measures they have taken. On expiry of the period referred to in the first subparagraph, the rules applied to the surveillance zone shall also apply to the protection zone. Article 12 1. Member States shall ensure that the following measures are applied in the surveillance zone: (a) all holdings having animals of susceptible species shall be identified; (b) the movement of animals of susceptible species on public roads shall be prohibited except for the purpose of leading them to pasture or animal buildings; the competent authority may, however, grant a derogation from that prohibition for the transit of animals by road or rail without unloading or stopping; (c) the transport of animals of susceptible species within the surveillance zone shall be subject to authorization by the competent authority; (d) animals of susceptible species must remain inside the surveillance zone for a maximum incubation period after the most recent recorded case of disease. Thereafter, animals may be removed from that zone to be transported under official supervision directly to a slaughterhouse designated by the competent authority for emergency slaugther. Such transport may be authorized by the competent authority only after the official veterinarian has carried out an examination of all the animals of the susceptible species on the holding and confirmed that none of the animals is suspected of being infected. The competent authority responsible for the slaughterhouse shall be informed of the intention to send animals to it. 2. The measures applied in the surveillance zone shall be kept in force for a period at least equal to the maximum incubation period after animals from the holding have been disposed of in accordance with Article 5 and cleaning and disinfection operations have been carried out in accordance with Article 16. However, where the disease is transmitted by an insect vector, the competent authority may fix the duration of the measures and lay down provisions for the possible introduction of sentinel animals. Member States shall forthwith inform the Commission and the other Member States, within the Standing Veterinary Committee, of the measures they have taken. Article 13 Where the prohibitions provided for in Articles 11 (1) (d) and 12 (1) (d) are maintained beyond 30 days because of the occurrence of further cases of the disease and as a result problems arise in keeping the animals, the competent authority may, following an application by the owner explaining the rounds for such application, by the owner explaining the grounds for such applications authorize the removal of the animals from a holding within the protection zone or the surveillance zone, provided that: (a) the official veterinarian has verified the facts; (b) an inspection of all animals on the holding has been carried out; (c) the animals to be transported have undergone a clinical examination, with negative result; (d) each animal has been marked by ear marking or has been identified by any other approved method; (e) the holding of destination is located either in the protection zone or within the surveillance zone. All the necessary precautions must be taken, in particular by cleaning and disinfecting lorries after transport, to avoid the risk of spreading the agent of the disease in the course of such transport. Article 14 1. Member States shall ensure that the competent authority takes all the necessary measures to keep at least persons established in the protection and surveillance zones informed of the restrictions in force and makes all necessary arrangements for the appropriate implementation of those measures. 2. Where, in a given region, the epizootic in question is exceptionally serious, all the additional measures to be taken by the Member States concerned shall be adopted under the procedure laid down in Article 26. Article 15 By way of derogation from the general provisions laid down in this Directive, specific provisions relating to the control and eradication measures for each respective disease: - are, for swine vesicular disease, set out in Annex II for swine vesicular disease, - are, for each of the other diseases listed in Annex I, adopted by the Council, acting by a qualified majority on a proposal from the Commission. Article 16 1. Member States shall ensure that: (a) the disinfectants and insecticides to be used and, where appropriate, their concentrations, are officially approved by the competent authority; (b) the cleaning, disinfection and disinsectization operations are carried out under official supervision: - in accordance with the instructions given by the official veterinarian, and - in such a way as to eliminate any risk of spread or survival of the agent of the disease; (c) on completion of the operations in (b), the official veterinarian makes sure that the measures have been carried out properly and that an appropriate period, of not less than 21 days, has elapsed to ensure that the disease in question has been completely eliminated before animals of susceptible species are re-introduced. 2. The procedures for cleaning and disinfecting an infected holding: - are, for swine vesicular disease, those set out in Annex II, - are determined, in the context of preparation of the specific measures for each disease listed in Annex I, in accordance with the procedure laid down in the second indent of Article 15. Article 17 1. Member States shall ensure that in each Member State there is designated: (a) a national laboratory with facilities and expert personnel enabling it to show at all times, and especially when the disease in question first appears, the type, sub-type and variant of the relevant virus and to confirm results obtained in regional diagnostic laboratories; (b) a national laboratory at which reagents used in regional diagnostic laboratories are tested. 2. The national laboratories designated for each of the diseases referred to shall be responsible for coordinating diagnostic standards and methods, and for the use of reagents. 3. The national laboratories designated for each of the diseases referred to shall be responsible for coordinating the diagnostic standards and methods laid down by each laboratory for diagnosis of the disease in question within the Member State. To this end, they: (a) may provide diagnostic reagents to national laboratories; (b) shall control the quality of all diagnostic reagents used in the Member State; (c) shall periodically arrange comparative tests; (d) shall hold isolates of the virus of the disease in question from cases confirmed in the Member State; (e) shall ensure the confirmation of positive results obtained in regional diagnostic laboratories. 4. However, by way of derogation from paragraph 1, Member States which do not have a national laboratory competent as regards the disease in question, may use the services of a national laboratory with competence in the matter of another Member State. 5. The list of national laboratories for swine vesicular disease is set out in Annex II. 6. The national laboratories designated for each of the diseases referred to shall cooperate with the respective Community reference laboratories referred to in Article 18. 7. The detailed rules for implementing this Article shall be adopted by the Commission under the procedure laid down in Article 25. Article 18 1. The Community reference laboratory for swine vesicular disease is indicated in Annex II. 2. The Community reference laboratories for each of the other diseases listed in Annex I shall be designated in accordance with the procedure laid down in the second indent of Article 15 in the context of preparation of the specific measures for each disease. 3. Without prejudice to Decision 90/424/EEC, and in particular Article 28 thereof, the functions and duties of the laboratories referred to in paragraphs 1 and 2 of this Article shall be those laid down in Annex III. Article 19 1. Vaccination against the diseases listed in Annex I may not be carried out except as a supplement to control measures taken when the disease in question broke out, in accordance with the following provisions: (a) the decision to introduce vaccination as a supplement to control measures shall be taken by the Commission, in cooperation with the Member State concerned, under the procedure laid down in Article 26; (b) this decision shall be based on the following criteria in particular: - the concentration of animals of the species concerned in the affected zone, - the characteristics and composition of each vaccine used, - the procedures for supervision of the distribution, storage and use of vaccines, - the species and age of the animals which may or must be vaccinated, - the areas in which vaccination may or must be carried out, - the duration of the vaccination campaign. 2. In the case referred to in paragraph 1: (a) the vaccination or re-vaccination of animals of susceptible species on the holdings referred to in Article 4 shall be prohibited; (b) hyper-immune serum injection shall be prohibited. 3. In the event of recourse to vaccination, the following rules shall apply: (a) all vaccinated animals must be identified by a clear and legible mark in accordance with a method approved by the procedure laid down in Article 25; (b) all vaccinated animals must remain within the vaccination zone unless sent to a slaughterhouse designated by the competent authority for immediate slaughter, in which case the movement of animals may be authorized only after the official veterinarian has carried out an examination of all the susceptible animals on the holding and confirmed that none of the animals is suspected of being infected. 4. When the vaccination operations have been completed, movements of animals of susceptible species from the vaccination zone may be permitted under the procedure laid down in Article 26, after a period determined by the same procedure. 5. Member States shall inform the Commission on a regular basis, within the Standing Veterinary Committee, of progress as regards the vaccination measures. 6. However, by way of derogation from paragraph 1, the decision to introduce emergency vaccination may be taken by the Member State concerned, following notification of the Commission, provided that the fundamental interests of the Community are not affected. That decision, which must in particular take into account the degree of concentration of the animals in certain regions, of the need to protect individual breeds and of the geographical area in which vaccination is carried out, shall forthwith be re-examined, under the procedure laid down in Article 26, by the Standing Veterinary Committee, which may decide to retain, modify or extend the measures or to bring them to an end. Article 20 1. Each Member State shall draw up a contingency plan applicable to all the diseases listed in Annex I, specifiying the national measures to be implemented in the event of an outbreak of any of these diseases. This plan must allow access to facilities, equipment, personnel and all other appropriate materials necessary for the rapid and efficient eradication of the outbreak. 2. The general criteria to be applied for drawing up the contingency plans are laid down in points 1 to 5 and 10 of Annex IV, with points 6 to 9 representing criteria to be adapted according to the disease concerned. Member States may however confine themselves to applying the criteria laid down in points 6 to 9 where the criteria in points 1 to 5 and 10 were already adopted when plans were submitted for the application of control measures for another disease. 3. Contingency plans drawn up in accordance with the criteria listed in Annex IV shall be submitted to the Commission: (i) no later than six months after this Directive is brought into effect as regards swine vesicular disease; (ii) no later than six months after implementation of the specific measures for each of the other diseases listed in Annex I. 4. The Commission shall examine the contingency plans in order to determine whether they permit the desired objective to be attained and shall suggest to the Member State concerned any amendments required in particular to ensure that they are compatible with those of the other Member States. The Commission shall approve the plans, if necessary amended, in accordance with the procedure laid down in Article 25. The plans may subsequently be amended or supplemented, in accordance with the same procedure, to take into account developments in the situation and the specific nature of the disease in question. Article 21 By way of derogation from the conditions provided for in Articles 19 and 20 as regards the contingency measures to be adopted by the Member States and so as to take account of the natural, geographical constraints particular to the French Overseas Departments, the Azores and Madeira and their remoteness from the central part of the Community's territory, the Member State concerned shall be authorized to apply particular control measures specific to each of the diseases listed in Annex I to this Directive. The Member State concerned shall, within the Standing Veterinary Committee, inform the Commission and the other Member States of the measures it has taken in this respect and in particular of the control measures implemented to ensure that animals from the territories in question or products from such animals are not dispatched to the other territories of the Community. Following the information procedure referred to in the second paragraph, Article 20 shall apply mutatis mutandis. Article 22 Commission experts may, in collaboration with the competent authorities, and in so far as is necessary to ensure uniform application of this Directive, make on-the-spot checks. In order to do this, they may check a representative percentage of holdings to see whether the competent authorities are checking that these holdings are fulfilling the requirements of this Directive. The Commission shall inform the Member States of the result of the checks carried out. A Member State in whose territory a check is being carried out shall give all the necessary assistance to the experts in carrying out their duties. The detailed rules for implementing this Article shall be determined in accordance with the procedure laid down in Article 25. Article 23 1. The conditions governing the Community's financial contribution to the measures connected with the application of this Directive are laid down in Decision 90/424/EEC. 2. Article 3 of Decision 90/424/EEC shall be amended as follows: (a) the following disease shall be added to the list of diseases specified in paragraph 1: 'haemorrhagic disease of deer'; (b) the following paragraph shall be added: '2a. The Member State concerned shall also qualify for a Community financial contribution where, on the outbreak of one of the diseases listed in paragraph 1, two or more Member States collaborate closely to control the epidemic, particularly in carrying out an epidemiological survey and disease surveillance measures. Without prejudice to the measures provided for under the common organization of markets concerned, the specific Community financial contribution shall be decided on in accordance with the procedure laid down in Article 41.' Article 24 1. Annexes I, III and IV shall be amended, as and when required, by the Council acting by a qualified majority on a proposal from the Commission, in particular in order to take into account developments in research and in diagnostic procedures. 2. The Commission may, in accordance with the procedure laid down in Article 25, amend Annex II, in particular in order to take into account technological and scientific developments and diagnostic methods. Article 25 1. Where the procedure laid down in this Article is to be followed, the chairman shall, without delay, refer the matter to the Standing Veterinary Committee, either on his own initiative or at the request of the 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 deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. (b) If 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 relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority. Article 26 1. Where the procedure laid down in this Article is to be followed, the matter shall without delay be referred to the Standing Veterinary Committee by its chairman, either on his own initiative or at the request of a Member State. 2. Within the Committee, the votes of the Member States shall be weighted as laid down in Article 148 (2) of the Treaty. The chairman shall not vote. 3. The representative of the Commission shall submit a draft of the measures to be adopted. The Committee shall deliver its opinion on these measures within two days. Opinions shall be delivered by a majority of 54 votes. 4. (a) The Commission shall adopt the measures and shall implement them immediately, where they are in accordance with the opinion of the Committee. (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 a proposal to the Council on the measures to be taken. The Council shall adopt the measures by a qualified majority. If the Council has not adopted any measures within 15 days of the date on which the matter is referred to it, the Commission shall adopt the proposed measures and shall implement them immediately unless the Council has voted against the measures by a simple majority. Article 27 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 October 1993. 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 texts of the main provisions of national law which they adopt in the field governed by this Directive. 3. The setting of the deadline for transposition into national law at 1 October 1993 shall be without prejudice to the abolition of veterinary checks at frontiers provided for in Directive 90/425/EEC. Article 28 This Directive is addressed to the Member States.

31992L0116

1992

Council Directive 92/116/EEC of 17 December 1992 amending and updating Directive 71/118/EEC on health problems affecting trade in fresh poultrymeat Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof, Having regard to the proposals 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 poultrymeat is included in the list of products in Annex II to the Treaty; whereas production of and trade in poultrymeat constitute an important source of income for the farming population; Whereas in order to ensure the rational development of this sector and to increase its productivity, public health rules affecting production and placing on the market must be laid down at Community level; Whereas Directive 71/118/EEC (4) established the health conditions to be met for the purpose of trade in poultrymeat; Whereas the Community must adopt the measures intended progressively to establish the internal market comprising an area without internal frontiers over a period expiring on 31 December 1992; Whereas Directive 89/662/EEC (5) laid down rules on the checks to be applied with a view to the completion of the internal market, and in particular abolished veterinary checks at frontiers between Member States; whereas, where trade is concerned, these rules must apply to fresh poultrymeat; Whereas, to achieve this purpose, it is necessary to modify the rules laid down in Directive 71/118/EEC in order to bring it into line with the new approach at Community level; Whereas prime responsibility for compliance with the requirements of this Directive should lie with producers and the authority should be obliged to monitor application of this principle on own-checks; Whereas the object of this adaptation must be in particular to standardize health requirements for the production, storage and transport of poultrymeat; Whereas it seems necessary to exclude certain types of direct sale from the scope of this Directive; Whereas this Directive should not apply to certain products sold directly by the producer to the consumer; Whereas it is possible that, owing to certain particular circumstances, some establishments operating prior to 1 January 1992 will not be able to comply with all the rules laid down by this Directive; Whereas a system of approval should be introduced for the establishments which meet the health requirements laid down by this Directive, together with a Community inspection procedure to ensure that the conditions for such approval are observed; Whereas low-capacity establishments should be approved by means of simplified structure and infrastructure criteria, while complying with the rules of hygiene laid down in this Directive; Whereas health marking of poultrymeat is the most appropriate way of satisfying the competent authorities of the place of destination that a consignment complies with the provisions of this Directive; whereas the health certificate should be maintained for the purposes of verifying the destination of certain poultrymeat, where it is maintained for animal health aspects; Whereas products placed on the Community market which come from third countries must afford the same degree of protection as regards human health; whereas guarantees equivalent to those offered by products of Community origin should therefore be required in respect of such products and they should be subject to the principles and rules on checks contained in Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries (6); Whereas, in order to allow the time necessary to set up a Community inspection system to ensure that third countries comply with the guarantees provided for in this Directive, national rules on checks should be maintained for a transitional period as regards these countries; Whereas the Commission should be entrusted with the task of taking certain measures for implementing this Directive; whereas, to that end, procedures should be laid down establishing close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee; Whereas, in view of the Hellenic Republic's particular supply difficulties arising from its geographical situation, special derogations should be permitted for that Member State; whereas for the same reason remote regions should be given additional time to comply with the requirements of this Directive; Whereas the adoption of specific rules for the products covered by this Directive is without prejudice to the adoption of rules on food hygiene and safety in general, on which the Commission has submitted a proposal for a framework Directive; Whereas the deadline for transposition of this Directive must not affect the abolition of veterinary checks at frontiers on 1 January 1993; Whereas for the sake of clarity Directive 71/118/EEC should be updated, Article 1 The title, the Articles and the Annexes to Directive 71/118/EEC shall be replaced by the text set out in Annex B to this Directive. Article 2 1. In Article 3 (A) of Council Directive 77/99/EEC of 21 December 1976 on health problems affecting intra-Community trade in meat products (7), point 2 is hereby amended as follows: (a) the first paragraph shall be replaced by the following: '2. have been prepared from fresh meat as defined in Article 2 (d), on the understanding that meat imported from a third country must meet the minimum requirements of Chapter III of Directive 71/118/EEC and have been inspected in accordance with Directive 90/675/EEC;' (b) the following shall be inserted in the introductory passage of the second paragraph, after the reference to Directive 64/433/EEC: 'the third subparagraph of Article 4 (1), and Chapter IX of Annex I to Directive 71/118/EEC, and in general any meat declared unfit for human consumption under Community rules'. 2. Commission Directive 80/879/EEC of 3 September 1980 on health marking of large packagings of fresh poultrymeat (8) is hereby repealed. 3. The second subparagraph of Article 3 (4) (i) of Council Directive 92/45/EEC of 16 June 1992 on public health and animal health problems relating to the killing of wild game and the placing on the market of wild-game meat (9) shall be replaced by the following: 'The provisions of point 68 of Chapter XII of Directive 71/118/EEC on the health marking of large packaging shall be applicable mutatis mutandis to meat of small wild game;'. 4. Council Directive 91/494/EEC of 26 June 1991 on animal health conditions governing intra-Community trade in and imports from third countries of fresh poultrymeat (10) is hereby amended as follows: (a) Article 3 (A) (6) shall be replaced by the following: '6. is, if it is intended for a Member State or a region of a Member State recognized as being free of Newcastle disease or a Member State after transit through a third country, accompanied by the health certificate shown in the Annex;' (b) the Annex shall be replaced by Annex A to this Directive. 5. In point 3 of the second paragraph of Article 2 of Council Directive 91/495/EEC of 27 November 1990 concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat (11), 'in Article 1 of Directive 71/118/EEC' shall be replaced by 'in Article 2 of Directive 71/118/EEC'. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1994, except in the case of establishments situated in: - remote regions, recognized in accordance with Article 17 of Directive 90/675/EEC (12), including - as regards the Kingdom of Spain - the Canary Islands, and with Article 13 of Directive 91/496/EEC (13), and - the new Laender of the Federal Republic of Germany covered by restructuring plans, in respect of which they must comply with this Directive not later than 1 January 1995; products from these establishments must be marketed in the regions concerned. They shall forthwith inform the Commission of the provisions they adopt. 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 main provisions of national law which they adopt in the field governed by this Directive. 3. The fact that the deadline for transposition of this Directive is set at 1 January 1994 shall not prejudice the abolition of veterinary checks at frontiers provided for in Directive 89/662/EEC. Article 4 This Directive is addressed to the Member States.

31992L0115

1992

Council Directive 92/115/EEC of 17 December 1992 amending for the first time Directive 88/344/EEC on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients 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 Article 2 (5) of Directive 88/344/EEC (4) provides that within two years of the adoption of that Directive the Commission shall, after consulting the Scientific Committee for Food, re-examine the provisions relating to the solvents in the Annex and to Methyl-propan-2-ol and propose any necessary amendments; Whereas as part of this amendment the Council should decide whether the residues of the extraction solvents in Part III of the Annex should refer to flavourings rather than foodstuffs; Whereas, three years after the adoption of Directive 88/344/EEC, the Commission should submit any appropriate proposal to the Council for some of the solvents in Article 2 (6), regulated so far only by national legislations; Whereas the Scientific Committee for Food reconsidered all the extraction solvents mentioned in that Directive in 1990 and in 1991 with the aim of replacing the temporary acceptable daily intakes (ADIs) established in 1981 with permanent assessments; whereas this has not always been possible, as appropriate information, although requested, has not been provided; whereas on the basis of the information received, the Scientific Committee for Food decided to confirm its acceptance or to retain the temporary status or to withdraw its previous temporary approval, depending on the substance concerned, Article 1 Directive 88/344/EEC is hereby amended as follows: 1. in Article 1: (a) the following subparagraph shall be added to paragraph 1: 'This Directive shall apply without prejudice to the provisions adopted under more specific Community rules.`; (b) Paragraph 2 shall be deleted; 2. in Article 2, paragraphs 5 and 6 shall be deleted; 3. the Annex shall be amended as follows: (a) IN PART I: - the following footnote 2 shall be added to Acetone: '(2) The use of Acetone in the refining of olive-pomace oil is forbidden.`; (b) IN PART II: - the solvents methanol and Propan-2-ol shall be added for all uses with a maximum residue content of 10 mg/kg, - footnote 1 shall be completed with the following sentence: 'The combined use of Hexane and Ethylmethylketone is forbidden.`, - footnote 2 shall be deleted. In the third column, the presence of 10 mg/kg in respect of Dichlormethane in roasted coffee, shall be replaced by the presence of '2 mg/kg`, - the following footnote 2 shall be added to Ethylmethylketone: '(2) The presence of n-Hexane in this solvent should not exceed 50 mg/kg. This solvent may not be used in combination with Hexane.`; (c) IN PART III: - Cyclohexane, Isobutane, and the footnote shall be deleted, - the presence of 0,1 mg/kg in respect of Dichloromethane shall be replaced by the presence of 0,02 mg/kg, - Propan-1-ol shall be added, with a maximum residue limit of 1 mg/kg, - a footnote shall be added to Hexane and Ethylmethylketone on the following page: '(1)The combined use of these two solvents is forbidden.` Article 2 1. Member States shall amend their laws, regulations and administrative provisions in such a way as to: - permit trade in products complying with this Directive at the latest by 1 July 1993, - prohibit trade in products not complying with this Directive with effect from 1 January 1994. They shall forthwith inform the Commission thereof. 2. When Member States adopt the measures referred to in paragraph 1, 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. Article 3 This Directive is addressed to the Member States.

31992L0120

1992

Council Directive 92/120/EEC of 17 December 1992 on the conditions for granting temporary and limited derogations from specific Community health rules on the production and marketing of certain products of animal origin Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 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 products of animal origin are included on the list of products in Annex II to the Treaty; whereas their marketing provides an important source of income for the farming population; Whereas to ensure rational development of the sector, increase productivity and progressively establish the conditions for a single market, health rules applying to production and marketing have been laid down at Community level; Whereas the Community has adopted measures enabling veterinary checks to be abolished at the frontiers between Member States for the products concerned; Whereas it is possible that, because of particular circumstances, some establishments will be unable to comply with all the specific rules laid down by 1 January 1993; whereas, in order to take account of local situations and prevent abrupt closures of establishments, arrangements should be made for temporary and limited derogations for establishments in operation before 1 January 1993; Whereas the Commission has deemed it necessary to obtain the opinion of the Scientific Veterinary Committee for the grant of derogations from the principle of systematic examination for trichinae in pigmeat; whereas since this opinion is not yet available, it is appropriate to make provision for the retention of temporary derogations for pigmeat not intended for Member States carrying out systematic examination for trichinae in pigmeat; Whereas these derogations must be strictly controlled to forestall any risk of abuse, Article 1 1. Member States may, until 31 December 1995, authorize establishments manufacturing products of animal origin referred to in Article 2 (b) of Directive 77/99/EEC which, on the date on which this Directive is notified, have not been judged to comply with the requirements laid down by Directive 77/99/EEC for their approval, to derogate from some of the structural requirements laid down in Chapter I of Annex A and in Chapters II (A) and III of Annex C to that Directive provided that animal products from such establishments are still subject to the rules on checks laid down by Article 5 (2) of Directive 89/662/EEC. 2. Derogations as referred to in paragraph 1 may be granted only to establishments which have submitted an application for a derogation to the competent national authority. This application must be supplemented, at the request of the competent authority, by a work plan and programme indicating the period within which the establishment will be able to comply with the structural requirements referred to in paragraph 1. Member States shall notify the Commission and the other Member States within the Standing Veterinary Committee of the establishments which comply with the requirements of that Directive as regards the products of animal origin referred to in Article 2 (b) of Directive 77/99/EEC. The notification must, for each individual establishment, specify the nature of the products manufactured. 3. Where financial assistance is requested from the Community, only requests in respect of projects complying with the requirements of Directive 77/99/EEC can be accepted. Article 2 1. Member States may, until 31 December 1995, grant derogations from the structural requirements provided for in Chapter IV of Annex I to Directive 64/433/EEC (4) and in Chapter I (1) (a) of Annex B to Directive 77/99/EEC for low-capacity coldstores in which meat and other foodstuffs are stored only if they are packaged and from any obligation to approve such establishments. 2. The provisions concerning the output appearing in the first subparagraph of Article 13 (1) of Directive 64/433/EEC shall apply to the slaughterhouses referred to in Article 4A of the aforementioned Directive until 31 December 1994. Likewise, for cutting plants, the figure appearing in the first subparagraph of Article 4A point 2 of the said Directive shall be five tonnes per week for the same period. Article 3 Member States may, pending the decision provided for in Article 6 (2) of Directive 64/433/EEC, derogate from the requirement in Article 6 (1) (a) of that Directive for fresh pigmeat intended for marketing in their territories and for that intended for any Member State having recourse to the same derogation. Member States having recourse to this derogation shall inform the Commission and the other Member States within the Standing Veterinary Committee. Article 4 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1993. 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. Article 5 This Directive is addressed to the Member States.

31992L0118

1992

Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof, Having regard to the proposals from the Commission (1), Having regard to the opinions of the European Parliament (2), Having regard to the opinions of the Economic and Social Committee (3), Whereas products of animal origin are included in the list of products in Annex II to the Treaty; whereas the placing on the market of such products constitutes an important source of income for part of the farming population; Whereas in order to ensure rational development in this sector and increase productivity, animal health and public health rules for the products in question should be laid down at Community level; Whereas the Community must adopt the measures intended progressively to establish the internal market consisting of an area without internal frontiers, over a period expiring on 31 December 1992; Whereas in view of the abovementioned objectives the Council has laid down animal health rules applicable to fresh meat, poultrymeat, meat products, game meat, rabbit meat and milk products; Whereas, save where otherwise provided, trade in products of animal origin must be liberalized, without prejudice to recourse to possible safeguard measures; Whereas, given the significant risk of the spread of diseases to which animals are exposed, for certain products of animal origin particular requirements should be specified to be imposed when they are placed on the market for the purposes of trade, particularly when intended for regions with a high health status; Whereas, when Directive 92/65/EEC was adopted, the Commission agreed to disassociate the animal health aspects applicable to animals from those applicable to products; Whereas, so as to allow checks at borders between Member States to be abolished on 1 January 1993, animal health and public health rules should be fixed to apply to all products subject to such checks trade in and imports of which have not yet been harmonized at Community level; Whereas, to achieve this objective, certain existing rules should be adapted for the adoption of the aforesaid measures; Whereas a system of approval should be introduced for the third countries and establishments which meet the requirements laid down by this Directive, together with a Community inspection procedure to ensure that the conditions for such approval are observed; Whereas the accompanying document for products is the best way of satisfying the competent authority of the place of destination that a consignment complies with the provisions of this Directive; whereas the public health or animal health certificate should be maintained for the purposes of verifying the destination of certain imported products; Whereas the rules, principles and safeguard measures established by Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries (4) should apply here; Whereas, in the context of intra-Community trade, the rules laid down in Directive 89/662/EEC should also be applied; Whereas the Commission should be entrusted with the task of adopting certain measures for implementing this Directive; whereas, to that end, procedures should be laid down establishing close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee; Whereas, in view of the particular supply difficulties arising from its geographical situation, special derogations should be permitted for the Hellenic Republic; Whereas the adoption of specific rules for the products covered by this Directive is without prejudice to the adoption of rules on food hygiene and safety in general, on which the Commission has submitted a proposal for a framework Directive, CHAPTER I General provisions Article 1 This Directive lays down the animal health and public health requirements governing trade in and imports into the Community of products of animal origin (including trade samples taken from such products) not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC (5) and, as regards pathogenic agents, to Directive 90/425/EEC. This Directive shall be without prejudice to the adoption of more detailed rules on animal health in the framework of the aforesaid specific rules nor the maintenance of restrictions on trade or imports of products covered by the specific rules referred to in the first paragraph based on the rules of public health. Article 2 1. For the purposes of this Directive: (a) trade means trade as defined by Article 2 (2) of Directive 89/662/EEC; (b) trade sample means a sample of no commercial value, taken on behalf of the owner or the person responsible for an establishment, which is representative of a given product of animal origin produced by that establishment, or constitutes a specimen of a product of animal origin the manufacture of which is contemplated, and which, for the purposes of subsequent examination, must bear a reference to the type of product, its composition and the species of animal from which it was obtained; (c) serious transmissible disease means all diseases covered by Directive 82/894/EEC (6); (d) pathogenic agents means any collection or culture of organisms or any derivative, present either alone or in the form of a manipulated combination of such a collection or culture of organisms capable of causing disease in any living being (other than man) and any modified derivatives of these organisms, which can carry or transmit an animal pathogen, or the tissue, cell culture, secretions or excreta by which or by means of which an animal pathogen can be carried or transmitted; this definition does not include the immunological veterinary medicinal products authorized pursuant to Directive 90/677/EEC (7); (e) processed animal protein intended for animal consumption means animal protein which has been treated so as to render it suitable for direct use as a feedingstuff or as an ingredient in a feedingstuff for animals. It includes fishmeal, meatmeal, bonemeal, hoofmeal, hornmeal, bloodmeal, feathermeal, dry greaves and other similar products including mixtures containing these products; (f) processed animal protein intended for human consumption means greaves, meatmeal and pork-rind powder referred to in Article 2 (b) of Directive 77/99/EEC (8); (g) apiculture product means honey, beeswax, royal jelly, propolis or pollen, not intended for human consumption or for industrial use. 2. In addition, the definitions contained in Article 2 of Directives 89/662/EEC, 90/425/EEC and 90/675/EEC shall apply mutatis mutandis. Article 3 Member States shall ensure that: - trade in and imports of products of animal origin referred to in Article 1 together with gelatins not intended for human consumption are not prohibited or restricted for animal health or public health reasons other than those arising from the application of this Directive or from Community legislation, and in particular any safeguard measures taken, - any new product of animal origin whose placing on the market in a Member State is authorized after the date provided for in Article 20 may not be the subject of trade or importation until a decision has been taken in accordance with the first paragraph of Article 15 after evaluation and, if appropriate, the opinion of the Scientific Veterinary Committee set up by Decision 81/651/EEC (9), of the real risk of the spread of serious transmissible diseases which could result from movement of the product, not only for the species from which the product originates but also for other species which could carry the disease, become a focus of disease or a risk to human health, - the other products of animal origin referred to in Article 2 (b) of Directive 77/99/EEC may not be the subject of trade or importation from third countries unless they meet the requirements of that Directive and the relevant requirements of this Directive. CHAPTER II Provisions applicable to trade Article 4 Member States shall take the necessary measures to ensure that, for the purposes of applying Article 4 (1) of Directive 89/662/EEC and Article 4 (1) (a) of Directive 90/425/EEC, the products of animal origin referred to in Annexes I and II and the second and third indents of Article 3 of this Directive may, without prejudice to the particular provisions to be adopted in implementation of Articles 10 (3) and 11, be the subject of trade only if they satisfy the following requirements: 1. they must meet the requirements of Article 5 and the specific requirements laid down in Annex I as regards animal health aspects and Annex II as regards public health aspects, 2. they must come from establishments which: (a) undertake, in the light of the specific requirements laid down in Annexes I and II for the products the establishment produces, to: - comply with the specific production requirements set out in this Directive, - establish and implement methods of monitoring and checking the critical points on the basis of the processes used, - depending on the products, take samples for analysis in a laboratory recognized by the competent authority for the purpose of checking compliance with the standards established by this Directive, - keep a record, whether written or otherwise recorded, of the information obtained pursuant to the preceding indents for presentation to the competent authority. The results of the various checks and tests in particular shall be kept for at least two years, - guarantee the administration of marking and labelling, - should the result of the laboratory examination or any other information available to them reveal the existence of a serious animal health or public health hazard, inform the competent authority, - consign, for purposes of trade, only products accompanied by a commercial document indicating the nature of the product, the name and, where appropriate, the veterinary approval number of the establishment of production; (b) they are under supervision by the competent authority to ensure that the operator or manager of the establishment complies with the requirements of this Directive; (c) they were registered by the competent authority on the basis of assurances from the establishment guaranteeing compliance with the requirements of this Directive. Article 5 Member States shall ensure that every necessary measure is taken to guarantee that products of animal origin referred to in Annexes I and II are not dispatched for purposes of trade from any holding, situated in a zone subject to restrictions because of the occurrence of a disease to which the species from which the product is derived is susceptible or from any establishment or zone from which movements or trade would constitute a risk to the animal health status of the Member States except where products are heat-treated in accordance with Community legislation. Particular assurances permitting, by way of derogation from the first paragraph, the movement of certain products may be adopted under the procedure laid down in Article 18 within the framework of safeguard measures. Article 6 Member States shall ensure that trade in pathogenic agents is subject to strict rules to be defined under the procedure laid down in Article 18. Article 7 1. The rules on checks established by Directive 89/662/EEC and, as regards pathogenic agents, by Directive 90/425/EEC shall apply, in particular as regards the organization of and follow-up to the checks to be carried out, to the products covered by this Directive. 2. Article 10 of Directive 90/425/EEC shall apply to the products covered by this Directive. 3. For the purposes of trade, the provisions of Article 12 of Directive 90/425/EEC shall be extended to establishments supplying products of animal origin covered by this Directive. 4. Without prejudice to the specific provisions of this Directive, the competent authority shall carry out any checks it may deem appropriate where it is suspected that this Directive is not being complied with. 5. Member States shall take the appropriate administrative or penal measures to penalize any infringement of this Directive, in particular where it is found that the certificates or documents drawn up do not correspond to the actual state of the products referred to in Annexes I and II, or that the products in question do not satisfy the requirements of this Directive or have not undergone the checks provided for therein. Article 8 In Chapter 1 (1) of Annex A to Directive 92/46/EEC (10) the following subparagraph is added: 'Milk and milk products must not come from a surveillance zone defined in accordance with Directive 85/511/EEC unless the milk has undergone pasteurization (71,7 °C for 15 seconds) under the supervision of the competent authority.' CHAPTER III Provisions applicable to imports into the Community Article 9 The requirements applicable to imports of products covered by this Directive must offer at least the guarantees provided for in Chapter II, including those established in implementation of Article 6, and those laid down in the second and third indents of Article 3. Article 10 1. For the purposes of uniform application of Article 9, the following provisions shall apply. 2. The products referred to in Annexes I and II and in the second and third indents of Article 3 may be imported into the Community only if they satisfy the following requirements: (a) unless otherwise specified in Annexes I and II, they must come from a third country or part of a third country on a list to be drawn up and updated in accordance with the procedure provided for in Article 18; (b) except for the products referred to in Chapter 5 (B) of Annex I, they must come from establishments for which the competent authority of the third country has provided the Commission with guarantees that they meet the requirements of paragraph 3 (a); (c) in the cases specifically provided for in Annexes I and II and in the second and third indents of Article 3, they must be accompanied by an animal health or public health certificate corresponding to a specimen to be drawn up under the procedure provided for in Article 18, certifying that the products meet the additional conditions or offer the equivalent guarantees referred to in paragraph 3 (a) and come from establishments offering such guarantees, and signed by an official veterinarian or, as appropriate, by any other competent authority recognized under the same procedure. 3. Under the procedure provided for in Article 18: (a) specific requirements shall be established - in particular for the protection of the Community from certain exotic diseases or diseases transmissible to man - or guarantees equivalent to those conditions. The specific requirements and equivalent guarantees established for third countries may not be more favourable than those laid down in Annexes I and II and in the second and third indents of Article 3; (b) a Community list shall be drawn up of third country establishments which satisfy the requirements of paragraph 2 (b); (c) the nature of any treatment or the measures to be taken to avoid recontamination of animal casings, eggs and egg products shall be established. 4. The decisions provided for in paragraphs 2 and 3 must be taken on the basis of evaluation and, if appropriate, the opinion of the Scientific Veterinary Committee, of the real risk of the spread of serious transmissible diseases or of diseases transmissible to man which could result from movement of the product, not only for the species from which the product originates but also for other species which could carry the disease or become a focus of disease or a risk to public health. 5. Experts from the Commission and the Member States shall carry out on-the-spot inspections to verify whether the guarantees given by the third country regarding the conditions of production and placing on the market can be considered equivalent to those applied in the Community. The experts from the Member States responsible for these inspections shall be appointed by the Commission, acting on proposals from the Member States. These inspections shall be made on behalf of the Community, which shall bear the cost of any expenditure involved. Pending organization of the inspections referred to in the first subparagraph, national rules applicable to inspection in third countries shall continue to apply, subject to notification, through the Standing Veterinary Committee, of any failure to comply with the guarantees offered in accordance with paragraph 3 found during these inspections. 6. Pending compilation of the lists provided for in paragraphs 2 (a) and 3 (b), Member States are authorized to maintain the controls provided for in Article 11 (2) of Directive 90/675/EEC and the national certificate required by products imported under existing national rules. Article 11 The procedure provided for in Article 18 shall be used to stipulate specific animal health requirements for imports into the Community and the nature and content of accompanying documents for products referred to in Annex I intended for experimental laboratories. Article 12 1. The principles and rules laid down in Directives 90/675/EEC and 91/496/EEC (11) shall apply, with particular reference to the organization of and follow-up to the inspections to be carried out by the Member States and the safeguard measures to be implemented. However, for certain types of product of animal origin, derogations may be adopted in accordance with the procedure laid down in Article 18, from the physical check provided for in Article 8 (2) of Directive 90/675/EEC. 2. In Article 4 (1) of Directive 90/675/EEC, the following subparagraph is added: 'However, where products of animal origin arrive in containers or are wrapped or packaged under vacuum, the identity check may be limited to ensuring that the seals placed by the official veterinarian or the competent authority on the container or package are intact and that the indications given thereon correspond to those included in the accompanying document or certificate.' Article 13 1. Member States may, by issuing an appropriate licence, permit the importation from third countries of products of animal origin referred to in Annexes I and II in the form of trade samples. 2. The licence mentioned in paragraph 1 must accompany the consignment and contain full details of the specific conditions under which the consignment may be imported, including any derogations from the checks provided for by Directive 90/675/EEC. 3. Where the consignment enters one Member State for onward transmission to a second Member State, the first Member State shall ensure that the consignment is accompanied by the appropriate licence. Movement shall take place in accordance with the provisions of Article 11 (2) of Directive 90/675/EEC. The responsibility for ensuring that the consignment complies with the conditions of the licence (and whether entry into its territory should be permitted) shall rest with the Member State which issues the licence. CHAPTER IV Common final provisions Article 14 1. Article 3 (d) of Directive 72/461/EEC (12) shall be deleted. Commission Decisions 92/183/EEC (13) and 92/187/ EEC (14) shall continue to apply for the requirements of this Directive, without prejudice to any amendments to be made to them under the procedure provided for in Article 18. 2. Directive 90/667/EEC is hereby amended as follows: (a) in Article 13 the following paragraph shall be added: '2. With a view to ensuring that the controls provided for in paragraph 1 are followed up: (a) processed products obtained from low-risk or high-risk materials must satisfy the requirements of Chapter 6 of Annex I to Directive 92/118/EEC (15)(); (b) low-risk materials, high-risk materials intended for processing in a plant designated in another Member State in accordance with the second sentence of Article 4 (1) and processed products obtained from high-risk or low-risk materials must be accompanied: - if they come from a plant approved in accordance with Article 4 or 5, by a commercial document specifying; - if appropriate, the nature of the treatment, - whether the product contains ruminant proteins, - if they come from another plant, by a certificate issued and signed by an official veterinarian indicating: - the methods of treatment used on the consignment, - the result of the salmonella tests, - whether the product contains ruminant proteins. (b) in Article 6, 'shall be established under the procedure laid down in Article 19' shall be replaced by 'are laid down under Chapter 10 of Annex I to Directive 92/118/EEC'; (c) in Article 14 the first paragraph shall be deleted. Article 15 The Council, acting by a qualified majority on a proposal from the Commission, shall adopt any new Annex laying down specific requirements for other products capable of presenting a real risk of spreading serious transmissible diseases or a real risk to human health. The Annexes shall, where the need arises, be amended under the procedure provided for in Article 18 in compliance with the general principles set out in the second indent of Article 3. Article 16 1. Member States shall be authorized to make the entry into their territory of products of animal origin referred to in Annexes I and II and in the second and third indents of Article 3 which were produced in the territory of a Member State and have passed through the territory of a third country subject to production of an animal health or public health certificate certifying compliance with the requirements of this Directive. 2. Member States which have recourse to the possibility laid down in paragraph 1 shall so inform the Commission and the other Member States within the Standing Veterinary Committee set up by Decision 68/361/EEC (16). Article 17 1. Annexes A and B to Directives 89/662/EEC and 90/425/EEC shall be replaced by the texts set out in Annex III to this Directive. 2. Directive 77/99/EEC is hereby amended as follows: - in Article 2 (b), point (iv) shall be deleted and points (v) and (vi) shall become (iv) and (v) respectively; - Article 6 (2) shall read: '2. Under the procedure laid down in Article 20, additional conditions may be set for the other products of animal origin so as to ensure the protection of public health.' Article 18 Where reference is made to the procedure provided for in this Article, the Standing Veterinary Committee shall act in accordance with the rules laid down in Article 17 of Directive 89/662/EEC. Article 19 Under the procedure provided for in Article 18, transitional measures may be adopted for a period of up to three years beginning on 1 July 1993 to facilitate the transition to the new arrangements established by this Directive. Article 20 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Articles 12 (2) and 17 by 1 January 1993 and with the other requirements of this Directive before 1 January 1994. They shall forthwith inform the Commission thereof. When these measures are adopted by the Member States, 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 texts of the main provisions of national law which they adopt in the field governed by this Directive. 3. The setting of the deadline for transposition into national law at 1 January 1994 shall be without prejudice to the abolition of veterinary checks at frontiers provided for by Directives 89/662/EEC and 90/425/EEC. Article 21 This Directive is addressed to the Member States.

31992L0114

1992

COUNCIL DIRECTIVE 92/114/EEC of 17 December 1992 relating to the external projections forward of the cab's rear panel of motor vehicles of category N Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 a 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 measures should be adopted with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas the technical requirements which motor vehicles must satisfy pursuant to national laws relate, inter alia, to the external projections of cabs of goods vehicles; Whereas these requirements differ from one Member State to another; whereas it is therefore necessary that all Member States adopt the same requirements either in addition to or in place of their existing rules in order to allow, in particular, the EEC type-approval procedure which was the subject of Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of Member States relating to the type-approval of motor vehicles and their trailers (4), to be applied in respect of each type of vehicle; Whereas, with a view to improving road safety, it is considered imperative and irgently necessary that the cabs of motor vehicles of category N do not exhibit sharp external projections to reduce the risk or the severity of injuries sustained by a person coming into contact with the external surface of the vehicle in the event of an accident; Whereas it is recommended to follow the technical requirements of ECE Regulation No 61 (Economic Commission for Europe of the United Nations) relating to the uniform provisions concerning external projections of the cabs of goods vehicles; whereas this ECE Regulation is annexed to the Agreement of 20 March 1958 concerning the adoption of uniform conditions of approval and reciprocal recognition of approval for motor vehicle equipment and parts, Article 1 For the purposes of this Directive, ‘vehicle’ means any motor vehicle of category N, as defined in Annex I to Directive 70/156/EEC, designed and constructed for use on the road, with or without bodywork, having at least four wheels and a maximum design speed exceeding 25 km/h. Article 2 No Member State may refuse EEC type-approval or national type-approval of a vehicle type, or refuse or prohibit the sale, registration, putting into service or use of a vehicle on grounds relating to their external projections forward of the cab's rear panel, if such vehicles satisfy the requirements set out in Annex I. Article 3 Any amendments necessary to adapt the requirements of the Annexes to technical progress shall be adopted in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC. Article 4 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 June 1993. They shall apply these provisions from 1 October 1993. When Member States adopt these provisions, they shall contain a reference to this Directive or 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 main provisions of national law that they adopt in the field governed by this Directive. Article 5 This Directive is addressed to the Member States.

31993L0001

1993

Commission Directive 93/1/EEC of 21 January 1993 amending Directive 77/535/EEC on the approximation of the laws of the Member States relating to methods of sampling and analysis for fertilizers (Analysis methods for trace elements) Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 76/116/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to fertilizers (1), as last amended by Directive 89/530/EEC (2), and in particular Article 9 (2) thereof, Whereas Article 8a of the Treaty establishes an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas Directive 89/530/EEC supplements and amends Directive 76/116/EEC in respect of the trace elements boron, cobalt, copper, iron, manganese, molybdenum and zinc in fertilizers; Whereas Commission Directive 77/535/EEC (3), as last amended by Directive 89/519/EEC (4), provides for official controls for Community fertilizers for the purpose of checking compliance with the requirements imposed by Community provisions concerning the quality and composition of fertilizers; whereas Directive 77/535/EEC should be supplemented so that fertilizers to which Directive 89/530/EEC applies can also be checked; Whereas, in view of the scope and effects of the proposed action, the Community measures provided for by this Directive are not only necessary but also indispensable for the attainment of the stated objectives, whereas these objectives cannot be achieved by Member States individually, and whereas their attainment at Community level is, in fact, already provided for by Directive 76/116/EEC; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for the Removal of Technical Barriers to Trade in Fertilizers, Article 1 The text set out in the Annex to this Directive is hereby added to Annex II to Directive 77/535/EEC. The methods are applicable to Community fertilizers for the determination of each trace element the declared content of which is less than or equal to 10 %. Article 2 1. Member States shall bring into force the provisions necessary to comply with this Directive by 31 December 1993. They shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive is addressed to the Member States.

31993L0002

1993

Commission Directive 93/2/EEC of 28 January 1993 amending Annex II to Council Directive 66/402/EEC on the marketing of cereal seed Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (1), as last amended by Directive 90/654/EEC (2), and in particular Article 21 (a) thereof, Whereas, according to present scientific and technical knowledge, it appears that certain varieties of oat (Avena sativa) of the 'naked oat` type have a potential value as fodder; Whereas, however, it is difficult to produce seed of these varieties with a germination capacity equal to that normally achieved by seed of the oat varieties; Whereas by Directive 88/506/EEC (3) the Commission declared that, in the light of the development of scientific and technical knowledge it was appropriate to reduce, for varieties of oats of the 'naked oat` type, the minimum germination capacity of 85 % of pure seed laid down for oats in Annex II to Directive 66/402/EEC to 75 %; Whereas that reduction applied only until 31 December 1992 so that further technical data about those varieties could be collected and assessed; Whereas further technical data has shown that it is appropriate for the reduction to continue indefinitely; Whereas the measures provided in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry, Article 1 Section (2) (B) (d) of Annex II to Directive 66/402/EEC is amended as follows: '(d) in the case of varieties of Avena sativa which are officially classified as of the "naked oat" type the minimum germination capacity is reduced to 75 % of pure seed. In such a case the official label shall be endorsed "minimum germination capacity 75 %"`. Article 2 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with the provisions of this Directive by 31 May 1993 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive is addressed to the Member States.

31993L0007

1993

Council Directive 93/7/EEC of 15 March 1993 on the return of cultural objects unlawfully removed from the territory of a Member State 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 Article 8a of the Treaty provides for the establishment, not later than 1 January 1993, of the internal market, which is to comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured in accordance with the provisions of the Treaty; Whereas, under the terms and within the limits of Article 36 of the Treaty, Member States will, after 1992, retain the right to define their national treasures and to take the necessary measures to protect them in this area without internal frontiers; Whereas arrangements should therefore be introduced enabling Member States to secure the return to their territory of cultural objects which are classified as national treasures within the meaning of the said Article 36 and have been removed from their territory in breach of the abovementioned national measures or of Council Regulation (EEC) No 3911/92 of 9 December 1992 on the export of cultural goods (4); whereas the implementation of these arrangements should be as simple and efficient as possible; whereas, to facilitate cooperation with regard to return, the scope of the arrangements should be confined to items belonging to common categories of cultural object; whereas the Annex to this Directive is consequently not intended to define objects which rank as 'national treasures' within the meaning of the said Article 36, but merely categories of object which may be classified as such and may accordingly be covered by the return procedure introduced by this Directive; Whereas cultural objects classified as national treasures and forming an integral part of public collections or inventories of ecclesiastical institutions but which do not fall within these common categories should also be covered by this Directive; Whereas administrative cooperation should be established between Member States as regards their national treasures, in close liaison with their cooperation in the field of stolen works of art and involving in particular the recording, with Interpol and other qualified bodies issuing similar lists, of lost, stolen or illegally removed cultural objects forming part of their national treasures and their public collections; Whereas the procedure introduced by this Directive is a first step in establishing cooperation between Member States in this field in the context of the internal market; whereas the aim is mutual recognition of the relevant national laws; whereas provision should therefore be made, in particular, for the Commission to be assisted by an advisory committee; Whereas Regulation (EEC) No 3911/92 introduces, together with this Directive, a Community system to protect Member States' cultural goods; whereas the date by which Member States have to comply with this Directive has to be as close as possible to the date of entry into force of that Regulation; whereas, having regard to the nature of their legal systems and the scope of the changes to their legislation necessary to implement this Directive, some Member States will need a longer period, Article 1 For the purposes of this Directive: 1. 'Cultural object' shall mean an object which: - is classified, before or after its unlawful removal from the territory of a Member State, among the 'national treasures possessing artistic, historic or archaeological value' under national legislation or administrative procedures within the meaning of Article 36 of the Treaty, and - belongs to one of the categories listed in the Annex or does not belong to one of these categories but forms an integral part of: - public collections listed in the inventories of museums, archives or libraries' conservation collection. For the purposes of this Directive, 'public collections' shall mean collections which are the property of a Member State, local or regional authority within a Member States or an institution situated in the territory of a Member State and defined as public in accordance with the legislation of that Member State, such institution being the property of, or significantly financed by, that Member State or a local or regional authority; - the inventories of ecclesiastical institutions. 2. 'Unlawfully removed from the territory of a Member State' shall mean: - removed from the territory of a Member State in breach of its rules on the protection of national treasures or in breach of Regulation (EEC) No 3911/92, or - not returned at the end of a period of lawful temporary removal or any breach of another condition governing such temporary removal. 3. 'Requesting Member State' shall mean the Member State from whose territory the cultural object has been unlawfully removed. 4. 'Requested Member State' shall mean the Member State in whose territory a cultural object unlawfully removed from the territory of another Member State is located. 5. 'Return' shall mean the physical return of the cultural object to the territory of the requesting Member State. 6. 'Possessor' shall mean the person physically holding the cultural object on his own account. 7. 'Holder' shall mean the person physically holding the cultural object for third parties. Article 2 Cultural objects which have been unlawfully removed from the territory of a Member State shall be returned in accordance with the procedure and in the circumstances provided for in this Directive. Article 3 Each Member State shall appoint one or more central authorities to carry out the tasks provided for in this Directive. Member States shall inform the Commission of all the central authorities they appoint pursuant to this Article. The Commission shall publish a lsit of these central authorities and any changes concerning them in the C series of the Official Journal of the European Communities. Article 4 Member States' central authorities shall cooperate and promote consultation between the Member States' competent national authorities. The latter shall in particular: 1. upon application by the requesting Member State, seek a specified cultural object which as been unlawfully removed from its territory, identifying the possessor and/or holder. The application must include all information needed to facilitate this search, with particular reference to the actual or presumed location of the object; 2. notify the Member States concerned, where a cultural object is found in their own territory and there are reasonable grounds for believing that it has been unlawfully removed from the territory of another Member State; 3. enable the competent authorities of the requesting Member State to check that the object in question is a cultural object, provided that the check is made within 2 months of the notification provided for in paragraph 2. If it is not made within the stipulated period, paragraphs 4 and 5 shall cease to apply; 4. take any necessary measures, in cooperation with the Member State concerned, for the physical preservation of the cultural object; 5. prevent, by the necessary interim measures, any action to evade the return procedure; 6. act as intermediary between the prossessor and/or holder and the requesting Member State with regard to return. To this end, the competent authorities of the requested Member States may, without prejudice to Article 5, first facilitate the implementation of an arbitration procedure, in accordance with the national legislation of the requested State and provided that the requesting State and the possessor or holder give their formal approval. Article 5 The requesting Member State may initiate, before the competent court in the requested Member State, proceedings against the possessor or, failing him, the holder, with the aim of securing the return of a cultural object which has been unlawfully removed from its territory. Proceedings may be brought only where the document initiating them is accompanied by: - a document describing the object covered by the request and stating that it is a cultural object, - a declaration by the competent authorities of the requesting Member State that the cultural object has been unlawfully removed from its territory. Article 6 The central authority of the requesting Member State shall forthwith inform the central authority of the requested Member State that proceedings have been initiated with the aim of securing the return of the object in question. The central authority of the requested Member State shall forthwith inform the central authorities of the other Member States. Article 7 1. Member States shall lay down in their legislation that the return proceedings provided for in this Directive may not be brought more than one year after the requesting Member State became aware of the location of the cultural object and of the identity of its possessor or holder. Such proceedings may, at all events, not be brought more than 30 years after the object was unlawfully removed from the territory of the requesting Member State. However, in the case of objects forming part of public collections, referred to in Article 1 (1), and ecclesiastical goods in the Member States where they are subject to special protection arrangements under national law, return proceedings shall be subject to a time-limit of 75 years, except in Member States where proceedings are not subject to a time-limit or in the case of bilateral agreements between Member States laying down a period exceeding 75 years. 2. Return proceedings may not be brought if removal from the national territory of the requesting Member State is no longer unlawful at the time when they are to be initiated. Article 8 Save as otherwise provided in Articles 7 and 13, the competent court shall order the return of the cultural object in question where it is found to be a cultural object within the meaning of Article 1 (1) and to have been removed unlawfully from national teerritory. Article 9 Where return of the object is ordered, the competent court in the requested States shall award the possessor such compensation as it deems fair according to the circumstances of the case, provided that it is satisfied that the possessor exercised due care and attention in acquiring the object. The burden of proof shall be governed by the legislation of the requested Member State. In the case of a donation or succession, the possessor shall not be in a more favourable position than the person from whom he acquired the object by that means. The requesting Member State shall pay such compensation upon return of the object. Article 10 Expenses incurred in implementing a decision ordering the return of a cultural object shall be borne by the requesting Member State. The same applies to the costs of the measures referred to in Article 4 (4). Article 11 Payment of the fair compensation and of the expenses referred to in Articles 9 and 10 respectively shall be without prejudice to the requesting Member State's right to take action with a view to recovering those amounts from the persons responsible for the unlawful removal of the cultural object from its territory. Article 12 Ownership of the cultural object after return shall be governed by that law of the requesting Member State. Article 13 This Directive shall apply only to cultural objects unlawfully removed from the territory of a Member State on or after 1 January 1993. Article 14 1. Each Member State may extend its obligation to return cultural objects to cover categories of objects other than those listed in the Annex. 2. Each Member State may apply the arrangements provided for by this Directive to requests for the return of cultural objects unlawfully removed from the territory of other Member States prior to 1 January 1993. Article 15 This Directive shall be without prejudice to any civil or criminal proceedings that may be brought, under the national laws of the Member States, by the requesting Member State and/or the owner of a cultural object that has been stolen. Article 16 1. Member States shall send the Commission every three years, and for the first time in February 1996, a report on the application of this Directive. 2. The Commission shall send the European Parliament, the Council and the Economic and Social Committee, every three years, a report reviewing the application of this Directive. 3. The Council shall review the effectiveness of this Directive after a period of application of three years and, acting on a proposal from the Commission, make any necessary adaptations. 4. In any event, the Council acting on a proposal from the Commission, shall examine every three years and, where appropriate, update the amounts indicated in the Annex, on the basis of economic and monetary indicators in the Community. Article 17 The Commission shall be assisted by the Committee set up by Article 8 of Regulation (EEC) No 3911/92. The Committee shall examine any question arising from the application of the Annex to this Directive which may be tabled by the chairman either on his own initiative or at the request of the representative of a Member State. Article 18 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within nine months of its adoption, except as far as the Kingdom of Belgium, the Federal Republic of Germany and the Kingdom of the Netherlands are concerned, which must conform to this Directive at the latest twelve months from the date of its adoption. 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. Article 19 This Directive is addressed to the Member States.

31993L0010

1993

Commission Directive 93/10/EEC of 15 March 1993 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (1), and in particular Article 3 thereof, After consulting the Scientific Committee for Food, Whereas the number and nature of the changes that have had to be made and should now be made to Council Directive 83/229/EEC of 25 April 1993 on the approximation of the laws of the Member States relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs (2), as last amended by Commission Directive 92/15/EEC (3), indicate the need for the said Directive to be replaced; Whereas the Community measures envisaged by this Directive are not only necessary but also indispensable for the attainment of the objectives of the internal market; whereas these objectives cannot be achieved by Member States individually; whereas, furthermore, their attainment at Community level is already provided for by Directive 89/109/EEC; Whereas Article 2 of Directive 89/109/EEC lays down that materials and articles, in their finished state, must not transfer their constituents to foodstuffs in quantities which could endanger human health or bring about an unacceptable change in the composition of the foodstuffs; Whereas, in order to achieve this objective in the case of regenerated cellulose film, the suitable instrument is a specific directive within the meaning of Article 3 of Directive 89/109/EEC; Whereas synthetic casings of regenerated cellulose should be the subject of specific provisions; Whereas the method for determining the absence of migration of colouring matters should be established at a later stage; Whereas, until criteria of purity and methods of analysis have been drawn up, national provisions should remain in force; Whereas the establishment of a list of approved substances, accompanied by limits to the quantities to be used, is sufficient in principle in this specific case to achieve the objective laid down in Article 2 of Directive 89/109/EEC; Whereas, however, the bis(2-hydroxyethyl)ether (= diethyleneglycol) and ethanediol (= monoethyleneglycol), can migrate extensively to certain foodstuffs and therefore in order to avoid this possibility, as a preventive measure, it is more appropriate to lay down definitively the maximum authorized quantity of such substances in foodstuffs which have been in contact with regenerated cellulose film; Whereas, to protect the health of the consumer, direct contact between foodstuffs and the printed surfaces of regenerated cellulose film should be avoided; Whereas the written declaration referred to in Article 6 (5) of Directive 89/109/EEC should be provided for in the event of professional use of regenerated cellulose film for materials and articles intended to come into contact with foodstuffs, except those which are, by their nature, intended for this use; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 1. This Directive is a specific directive within the meaning of Article 3 of Directive 89/109/EEC. 2. This Directive shall apply to regenerated cellulose film within the meaning of the description given in Annex I which either: (a) constitutes a finished product in itself; or (b) forms part of a finished product containing other materials, and which is intended to come into contact with foodstuffs or which, by virtue of its purpose, does come into such contact. 3. This Directive does not apply to: (a) regenerated cellulose film which, on the side intended to come into contact with foodstuffs or which, by virtue of its purpose does come into such contact, has a coating exceeding 50 mg/dm2; (b) synthetic casings of regenerated cellulose. Article 2 1. Only those substances or groups of substances listed in Annex II may be used for the manufacture of regenerated cellulose film and only under the conditions laid down therein. 2. By way of derogation from paragraph 1, substances other than those listed in Annex II may be used when these substances are employed as colouring matter (dyes and pigments) or as adhesives, provided that there is no trace of migration of the substances into or onto foodstuffs, detectable by a validated method. Article 3 Printed surfaces of regenerated cellulose film shall not come into contact with the foodstuffs. Article 4 1. At the marketing stages other than the retail stages, materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs shall be accompanied by a written declaration in accordance with Article 6 (5) of Directive 89/109/EEC. 2. Paragraph 1 does not apply to materials and articles made of regenerated cellulose film which by their nature are clearly intended to come into contact with foodstuffs. 3. Where special conditions of use are indicated, the material or article made of regenerated cellulose film shall be labelled accordingly. Article 5 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive as from 1 January 1994. They shall immediately inform the Commission thereof. Member States shall: - permit, as from 1 January 1994, the trade in and use of regenerated cellulose film which is intended to come into contact with foodstuffs complying with this Directive, - prohibit, as from 1 January 1994, the trade in and use of regenerated cellulose film which is intended to come into contact with foodstuffs and which complies with neither this Directive nor Directive 83/229/EEC, - prohibit, as from 1 January 1995, the trade in and use of regenerated cellulose film which is intended to come into contact with foodstuffs and which does not comply with this Directive but did comply with Directive 83/229/EEC. 2. When Member States adopt the measures referred to in paragraph 1, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 6 1. Directive 83/229/EEC is hereby repealed as from 1 January 1994. 2. References to Directive 83/229/EEC shall be construed as references to this Directive and should be read in accordance with the correlation table appearing in Annex III. Article 7 This Directive is addressed to the Member States.

31993L0011

1993

Commission Directive 93/11/EEC of 15 March 1993 concerning the release of the N-nitrosamines and N- nitrosatable substances from elastomer or rubber teats and soothers Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (1), and in particular Article 3 thereof, Whereas the Community measures envisaged by this Directive are not only necessary but also indispensable for the attainment of the objectives of the internal market; whereas these objectives cannot be achieved by Member States individually; whereas furthermore their attainment at Community level is already provided for by Directive 89/109/EEC; Whereas it has been shown that teats and soothers, made of elastomer or rubber, may release N-nitrosamines and substances capable of being converted into N-nitrosamines (N-nitrosatable substances); Whereas the Scientific Committee for Food has given the opinion that N-nitrosamines and N-nitrosatable substances may endanger human health owing to their toxicity and has therefore recommended that migration of these substances from the abovementioned articles be kept below the detection limit of an appropriate sensitive method; Whereas Article 2 of Directive 89/109/EEC lays down that materials and articles, in their finished state, must not transfer their constituents to foodstuffs in quantities which could endanger human health; Whereas, in order to achieve this objective, the suitable instrument for teats is a specific directive within the meaning of Article 3 of Directive 89/109/EEC; Whereas the use of soothers may produce the same type of risk and therefore it is convenient to adopt the same provisions for these articles too; Whereas it is necessary to act immediately and therefore this Directive is limited to establishing specific rules regarding the release of N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers, postponing to a more general directive regarding elastomers and rubber the solution of other problems concerning teats and soothers; Whereas this Directive establishes the basic rules and general criteria for determining the release of N-nitrosamines and N-nitrosatable substances and postpones the definition of a detailed method of analysis; Whereas the outline method of analysis given in the Annexes is adopted as a temporary measure until more results are available on the performance of this method and possible alternative methods; Whereas the Commission has undertaken to promote further research on methods of analysis, to review the proposed methodology and to consider establishing analytical tolerances in the light of that research; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 This Directive is a specific directive within the meaning of Article 3 of Directive 89/109/EEC. It concerns the release of N-nitrosamines and of substances capable of being converted into N-nitrosamines, hereinafter called 'N-nitrosatable substances`, from teats and soothers, made of elastomer or rubber. Article 2 The teats and soothers referred to in Article 1 must not pass on to release-test liquid (saliva test solution) under the conditions specified in Annex I any N-nitrosamine and N-nitrosatable substance detectable by a validated method which complies with the criteria laid down in Annex II and which can detect the following quantities: - 0,01 mg in total of N-nitrosamines released/kg (of the parts of teat or soother made of elastomer or rubber), - 0,1 mg in total of N-nitrosatable substances/kg (of the parts of teat or soother made of elastomer or rubber). Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive as from 1 April 1994. They shall immediately inform the Commission thereof. Member States shall: - permit, as from 1 April 1994, the trade in and use of teats and soothers complying with this Directive, - prohibit, as from 1 April 1995, the trade in and use of teats and soothers which do not comply with this Directive. 2. When Member States adopt the measures referred to in paragraph 1, these shall contain a reference to this Directive or shall be accompanied by such reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 4 This Directive is addressed to the Member States.

31993L0009

1993

Commission Directive 93/9/EEC of 15 March 1993 amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 89/109/EEC (1) of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs, and in particular Article 3 thereof, After consulting the Scientific Committee for Food, Whereas the Community measures envisaged by this Directive are not only necessary but also indispensable for the attainment of the objectives of the internal market; whereas these objectives cannot be achieved by Member States individually, and whereas furthermore their attainment at Community level is already provided for by Directive 89/109/EEC; Whereas Commission Directive 90/128/EEC (2), as amended by Directive 92/39/EEC (3), and in particular Article 3 (4) thereof, provides for the revision of Annex II and particularly Section B; Whereas, on the basis of the available information, certain substances provisionally admitted at national level may be included in the Community list, while others must be definitively prohibited; Whereas certain substances provisionally admitted at national level may continue to be permitted for a further specified period since the data requested by the Scientific Committee for Food are not yet available but the required studies are ongoing or are planned; Whereas other substances have been requested for use following the adoption of Directive 90/128/EEC and the technical data supplied permit their inclusion in the Community list; Whereas, for certain substances, the restrictions already set out should be amended according to the available information; Whereas it is necessary to permit the continued use of certain well-defined substances contained in those groups of substances which are not well-defined and are now deleted, pending a decision on their inclusion in the Community list; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 Directive 90/128/EEC is amended as follows: 1. The following paragraph 3 is added to Article 5: '3. The verification of compliance with the specific migration limits provided for in paragraph 1 shall not be compulsory, if it can be established that, by assuming complete migration of the residual substance in the material or article, it cannot exceed the specific limit of migration.' 2. Annex II is amended as follows: (a) Point 8 is hereby amended as follows: - the following text is inserted after 'QM (T) = maximum permitted quantity of the "residual" substance in the material or article expressed as total of moiety or substance(s) indicated': 'For the purpose of this Directive "QM (T)" means that the maximum permitted quantity of the "residual" substance in the material or article should be determined by a validated method of analysis at the specified limit. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method.' - the following text is inserted after 'SML (T) = specific migration limit in food or in food simulant expressed as total of moiety or substance(s) indicated': 'For the purpose of this Directive "SML (T)" menas that the specific migration of the substances should be determined by a validated method of analysis at the specified limit. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method.' (b) Section A: - the substances appearing in Annex I to this Directive are added, - the content of the column 'Restrictions' for the substances appearing in Annex II to this Directive is amended as indicated therein; (c) Section B: - the substances appearing in Annex III to this Directive are added, as a replacement for those groups of substances which are not well defined and which are deleted by this Directive, - the substances appearing in Annex IV to this Directive are deleted; (d) the substances appearing in Annex V to this Directive are transferred from Section B to A and are now subject to the restrictions, if any, specified. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive as from 1 April 1994. They shall immediately inform the Commission thereof. Member States shall: - permit, as from 1 April 1994, the trade in and use of plastic materials and articles intended to come into contact with foodstuffs complying with this Directive, - prohibit, as from 1 April 1996, the trade in and use of plastic materials and articles intended to come into contact with foodstuffs and which do not comply with this Directive. 2. When Member States adopt the measures referred to in paragraph 1, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

31993L0008

1993

Commission Directive 93/8/EEC of 15 March 1993 amending Council Directive 82/711/EEC laying down the basic rules necessary for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (1), and in particular Article 3 thereof, Whereas the Community measures envisaged by this Directive are not only necessary but also indispensable for the attainment of the objectives of the internal market; whereas these objectives cannot be achieved by Member States individually, and whereas furthermore their attainment at Community level is already provided for by Directive 89/109/EEC; Whereas Commission Directive 90/128/EEC of 23 February 1990 relating to plastic materials and articles intended to come into contact with foodstuffs (2), as amended by Directive 92/39/EEC (3), provides the possibility of carrying out the migration tests either on foodstuffs or on food simulants, whilst Council Directive 82/711/EEC (4) requires the migration tests to be carried out only on food simulants unless the method of analysis which enables migration into foodstuffs to be established has been adopted officially; whereas this discrepancy is capable of affecting the proper application of the Directives and whereas it is therefore necessary to eliminate it; Whereas the increasing use of microwave ovens makes it necessary to establish new specific test conditions; Whereas it is necessary to remove the possibility given to the Member States to adopt national rules for high-temperature testing in order to eliminate the existing discrepancies; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 Directive 82/711/EEC is amended as follows: 1. Articles 2 and 3 are replaced by the following: 'Article 2 The overall and specific migration levels of constituents of the materials and articles referred to in Article 1 into or onto foodstuffs or food simulants must not exceed the limits laid down in Commission Directive 90/128/EEC (*) or in any other relevant specific directive. Article 3 1. Verification of compliance of migration into foodstuffs with the migration limits shall be carried out under the most extreme conditions of time and temperature foreseeable in actual use. Verification of compliance of migration into food simulants with the migration limits shall be carried out using conventional migration tests, the basic rules for which are laid down in the Annex to this Directive. 2. (a) However, where a Member State, as a result of new information or of a reassessment of existing information made since this Directive was adopted, has detailed grounds for establishing that for a given plastic material or article the basic rules laid down in the Annex for migration tests are technically unsuitable or because the actual conditions of use are basically different from the test conditions specified in the table in the Annex, that Member State may, within its territory and only for the particular case, temporarily suspend application of the basic rules referred to in the Annex and permit the use of more appropriate basic rules. It shall immediately inform the other Member States and the Commission thereof and give the reasons for its decision. (b) The Commission shall examine, as soon as possible, the reasons given by the Member States concerned and shall consult the Member States within the Standing Committee for Foodstuffs and shall then deliver its opinion forthwith and amend this Directive, if necessary. In that case, the Member State which has adopted the more appropriate basic rules may retain them until the said amendments enter into force. (*) OJ No L 75, 21. 3. 1990, p. 19, amended by OJ No L 349, 13. 12. 1990, p. 26.' 2. The Annex is replaced by the Annex hereto. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive as from 1 April 1994. They shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

31993L0006

1993

Council Directive 93/6/EEC of 15 March 1993 on the capital adequacy of investments firms and credit institutions Having regard to the Treaty establishing the European Economic Community, and in particular the first and third sentences of Article 57 (2) 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 the main objective of Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field (4) is to allow investment firms authorized by the competent authorities of their home Member States and supervised by the same authorities to establish branches and provide services freely in other Member States; whereas that Directive accordingly provides for the coordination of the rules governing the authorization and pursuit of the business of investment firms; Whereas that Directive does not, however, establish common standards for the own funds of investment firms nor indeed does it establish the amounts of the initial capital of such firms; whereas it does not establish a common framework for monitoring the risks incurred by the same firms; whereas it refers, in several of its provisions, to another Community initiative, the objective of which would be precisely to adopt coordinated measures in those fields; Whereas the approach that has been adopted is to effect only the essential harmonization that is necessary and sufficient to secure the mutual recognition of authorization and of prudential supervision systems; whereas the adoption of measures to coordinate the definition of the own funds of investment firms, the establishment of the amounts of their initial capital and the establishment of a common framework for monitoring the risks incurred by investment firms are essential aspects of the harmonization necessary for the achievement of mutual recognition within the framework of the internal financial market; Whereas it is appropriate to establish different amounts of initial capital depending on the range of activities that investment firms are authorized to undertake; Whereas existing investment firms should be permitted, under certain conditions, to continue their business even if they do not comply with the minimum amount of initial capital fixed for new firms; Whereas the Member States may also establish rules stricter than those provided for in this Directive; Whereas this Directive forms part of the wider international effort to bring about approximation of the rules in force regarding the supervision of investment firms and credit institutions (hereinafter referred to collectively as 'institutions'); Whereas common basic standards for the own funds of institutions are a key feature in an internal market in the investment services sector, since own funds serve to ensure the continuity of institutions and to protect investors; Whereas in a common financial market, institutions, whether they are investment firms or credit institutions, engage in direct competition with one another; Whereas it is therefore desirable to achieve equality in the treatment of credit institutions and investment firms; Whereas, as regards credit institutions, common standards are already established for the supervision and monitoring of credit risks in Council Directive 89/647/EEC of 18 December 1989 on a solvency ratio for credit institutions (5); Whereas it is necessary to develop common standards for market risks incurred by credit institutions and provide a complementary framework for the supervision of the risks incurred by institutions, in particular market risks, and more especially position risks, counterparty/ settlement risks and foreign-exchange risks; Whereas it is necessary to introduce the concept of a 'trading book' comprising positions in securities and other financial instruments which are held for trading purposes and are subject mainly to market risks and exposures relating to certain financial services provided to customers; Whereas it is desirable that institutions with negligible trading-book business, in both absolute and relative terms, should be able to apply Directive 89/647/EEC, rather than the requirements imposed in Annexes I and II to this Directive; Whereas it is important that monitoring of settlement/delivery risks should take account of the existence of systems offering adequate protection that reduces that risk; Whereas, in any case, institutions must comply with this Directive as regards the coverage of the foreign-exchange risks on their overall business; whereas lower capital requirements should be imposed for positions in closely correlated currencies, whether statistically confirmed or arising out of binding intergovernmental agreements, with a view in particular to the creation of the European Monetary Union; Whereas the existence, in all institutions, of internal systems for monitoring and controlling interest-rate risks on all of their business is a particularly important way of minimizing such risks; whereas, consequently, such systems must be subject to overview by the competent authorities; Whereas Council Directive 92/121/EEC of 21 December 1992 on the monitoring and control of large exposures of credit institutions (6) is not aimed at establishing common rules for monitoring large exposures in activities which are principally subject to market risks; whereas that Directive makes reference to another Community initiative intended to adopt the requisite coordination of methods in that field; Whereas it is necessary to adopt common rules for the monitoring and control of large exposures incurred by investment firms; Whereas the own funds of credit institutions have already been defined in Council Directive 89/299/EEC of 17 April 1989 on the own funds of credit institutions (7); Whereas the basis for the definition of the own funds of institutions should be that definition; Whereas, however, there are reasons why for the purposes of this Directive the definition of the own funds of institutions may differ from that in the aforementioned Directive in order to take account of the particular characteristics of the activities carried on by those institutions which mainly involve market risks; Whereas Council Directive 92/30/EEC of 6 April 1992 on the supervision of credit institutions on a consolidated basis (8) states the principle of consolidation; whereas it does not establish common rules for the consolidation of financial institutions which are involved in activities principally subject to market risks; whereas that Directive makes reference to another Community initiative intended to adopt coordinated measures in that field; Whereas Directive 92/30/EEC does not apply to groups which include one or more investment firms but no credit institutions; whereas it was, however, felt desirable to provide a common framework for the introduction of the supervision of investment firms on a consolidated basis; Whereas technical adaptations to the detailed rules laid down in this Directive may from time to time be necessary to take account of new developments in the investment services field; whereas the Commission will accordingly propose such adaptations as are necessary; Whereas the Council should, at a later stage, adopt provision for the adaptation of this Directive to technical progress in accordance with Council Decision 87/373/EEC of 13 July 1987 laying down the procedures for the exercise of implementing powers conferred on the Commission (9); whereas meanwhile the Council itself, on a proposal from the Commission, should carry out such adaptations; Whereas provision should be made for the review of this Directive within three years of the date of its application in the light of experience, developments on financial markets and work in international fora of regulatory authorities; whereas that review should also include the possible review of the list of areas that may be subject to technical adjustment; Whereas this Directive and Directive 93/22/EEC on investment services in the securities field are so closely interrelated that their entry into force on different dates could lead to the distortion of competition, Article 1 1. Member States shall apply the requirements of this Directive to investment firms and credit institutions as defined in Article 2. 2. A Member State may impose additional or more stringent requirements on the investment firms and credit institutions that it has authorized. DEFINITIONS Article 2 For the purposes of this Directive: 1. credit institutions shall mean all institutions that satisfy the definition in the first indent of Article 1 of the First Council Directive (77/780/EEC) of 12 December 1977 on the coordination of laws, regulations and administrative provisions relating to the taking up and pursuit of the business of credit institutions (10) which are subject to the requirements imposed by Directive 89/647/EEC; 2. investment firms shall mean all institutions that satisfy the definition in point 2 of Article 1 of Directive 93/22/EEC, which are subject to the requirements imposed by the same Directive, excluding: - credit institutions, - local firms as defined in 20, and - firms which only receive and transmit orders from investors without holding money or securities belonging to their clients and which for that reason may not at any time place themselves in debit with their clients; 3. institutions shall mean credit institutions and investment firms; 4. recognized third-country investment firms shall mean firms which, if they were established within the Community, would be covered by the definition of investment firm in 2, which are authorized in a third country and which are subject to and comply with prudential rules considered by the competent authorities as at least as stringent as those laid down in this Directive; 5. financial instruments shall mean the instruments listed in Section B of the Annex to Directive 93/22/EEC; 6. the trading book of an institution shall consist of: (a) its proprietary positions in financial instruments which are held for resale and/or which are taken on by the institution with the intention of benefiting in the short term from actual and/or expected differences between their buying and selling prices, or from other price or interest-rate variations, and positions in financial instruments arising from matched principal broking, or positions taken in order to hedge other elements of the trading book; (b) the exposures due to the unsettled transactions, free deliveries and over-the-counter (OTC) derivative instruments referred to in paragraphs 1, 2, 3 and 5 of Annex II, the exposures due to repurchase agreements and securities lending which are based on securities included in the trading book as defined in (a) referred to in paragraph 4 of Annex II, those exposures due to reverse repurchase agreements and securities-borrowing transactions described in the same paragraph, provided the competent authorities so approve, which meet either the conditions (i), (ii), (iii) and (v) or conditions (iv) and (v) as follows: (i) the exposures are marked to market daily following the procedures laid down in Annex II; (ii) the collateral is adjusted in order to take account of material changes in the value of the securities involved in the agreement or transaction in question, according to a rule acceptable to the competent authorities; (iii) the agreement or transaction provides for the claims of the institution to be automatically and immediately offset against the claims of its counter-party in the event of the latter's defaulting; (iv) the agreement or transaction in question is an interprofessional one; (v) such agreements and transactions are confined to their accepted and appropriate use and artificial transactions, especially those not of a short-term nature, are excluded; and (c) those exposures in the form of fees, commission, interest, dividends and margin on exchange-traded derivatives which are directly related to the items included in the trading book referred to in paragraph 6 of Annex II. Particular items shall be included in or excluded from the trading book in accordance with objective procedures including, where appropriate, accounting standards in the institution concerned, such procedures and their consistent implementation being subject to review by the competent authorities; 7. parent undertaking, subsidiary undertaking and financial institution shall be defined in accordance with Article 1 of Directive 92/30/EEC; 8. financial holding company shall mean a financial institution the subsidiary undertakings of which are either exclusively or mainly credit institutions, investment firms or other financial institutions, one of which at least is a credit institution or an investment firm; 9. risk weightings shall mean the degrees of credit risk applicable to the relevant counter-parties under Directive 89/647/EEC. However, assets constituting claims on and other exposures to investment firms or recognized third-country investment firms and exposures incurred to recognized clearing houses and exchanges shall be assigned the same weighting as that assigned where the relevant counterparty is a credit institution; 10. over-the-counter (OTC) derivative instruments shall mean the interest-rate and foreign-exchange contracts referred to in Annex II to Directive 89/647/EEC and off-balance-sheet contracts based on equities, provided that no such contracts are traded on recognized exchanges where they are subject to daily margin requirements and, in the case of foreign-exchange contracts, that every such contract has an original maturity of more than 14 calendar days; 11. regulated market shall mean a market that satisfies the definition given in Article 1 (13) of Directive 93/22/EEC; 12. qualifying items shall mean long and short positions in the assets referred to in Article 6 (1) (b) of Directive 89/647/EEC and in debt instruments issued by investment firms or by recognized third-country investment firms. It shall also mean long and short positions in debt instruments provided that such instruments meet the following conditions: such instruments must firstly be listed on at least one regulated market in a Member State or on a stock exchange in a third country provided that that exchange is recognized by the competent authorities of the relevant Member State; and secondly both be considered by the institution concerned to be sufficiently liquid and, because of the solvency of the issuer, be subject to a degree of default risk which is comparable to or lower than that of the assets referred to in Article 6 (1) (b) of Directive 89/647/EEC; the manner in which the instruments are assessed shall be subject to scrutiny by the competent authorities, which shall overturn the judgment of the institution if they consider that the instruments concerned are subject to too high a degree of default risk to be qualifying items. Notwithstanding the foregoing and pending further coordination, the competent authorities shall have the discretion to recognize as qualifying items instruments which are sufficiently liquid and which, because of the solvency of the issuer, are subject to a degree of default risk which is comparable to or lower than that of the assets referred to in Article 6 (1) (b) of Directive 89/647/EEC. The default risk associated with such instruments must have been evaluated at such a level by at least two credit-rating agencies recognized by the competent authorities or by only one such credit-rating agency so long as they are not rated below such a level by any other credit-rating agency recognized by the competent authorities. The competent authorities may, however, waive the condition imposed in the preceding sentence if they judge it inappropriate in the light of, for example, the characteristics of the market, the issuer, the issue, or some combination of those characteristics. Furthermore, the competent authorities shall require the institutions to apply the maximum weighting shown in Table 1 in paragraph 14 of Annex I to instruments which show a particular risk because of the insufficient solvency of the issuer or liquidity. The competent authorities of each Member State shall regularly provide the Council and the Commission with information concerning the methods used to evaluate the qualifying items, in particular the methods used to assess the degree of liquidity of the issue and the solvency of the issuer; 13. central government items shall mean long and short positions in the assets referred to in Article 6 (1) (a) of Directive 89/647/EEC and those assigned a weighting of 0 % in Article 7 of the same Directive; 14. convertible shall mean a security which, at the option of the holder, can be exchanged for another security, usually the equity of the issuer; 15. warrant shall mean an instrument which gives the holder the right to purchase a number of shares of common stock or bonds at a stipulated price until the warrant's expiry date. They may be settled by the delivery of the securities themselves or their equivalent in cash; 16. covered warrant shall mean an instrument issued by an entity other than the issuer of the underlying instrument which gives the holder the right to purchase a number of shares of common stock or bonds at a stipulated price or a right to secure a profit or avoid a loss by reference to fluctuations in an index relating to any of the financial instruments listed in Section B of the Annex to Directive 93/22/EEC until the warrant's expiry date; 17. repurchase agreement and reverse repurchase agreement shall mean any agreement in which an institution or its counter-party transfers securities or guaranteed rights relating to title to securities where that guarantee is issued by a recognized exchange which holds the rights to the securities and the agreement does not allow an institution to transfer or pledge a particular security to more than one counter-party at one time, subject to a commitment to repurchase them (or substituted securities of the same description) at a specified price on a future date specified, or to be specified, by the transferor, being a repurchase agreement for the institution selling the securities and a reverse repurchase agreement for the institution buying them. A reverse repurchase agreement shall be considered an interprofessional transaction when the counter-party is subject to prudential coordination at Community level or is a Zone A credit institution as defined in Directive 89/647/EEC or is a recognized third-country investment firm or when the agreement is concluded with a recognized clearing house or exchange; 18. securities lending and securities borrowing shall mean any transaction in which an institution or its counter-party transfers securities against appropriate collateral subject to a commitment that the borrower will return equivalent securities at some future date or when requested to do so by the transferor, being securities lending for the institution transferring the securities and securities borrowing for the institution to which they are transferred. Securities borrowing shall be considered an interprofessional transaction when the counterparty is subject to prudential coordination at Community level or is a Zone A credit institution as defined in Directive 89/647/EEC or is a recognized third-country investment firm or when the transaction is concluded with a recognized clearing house or exchange; 19. clearing member shall mean a member of the exchange or the clearing house which has a direct contractual relationship with the central counterparty (market guarantor); non-clearing members must have their trades routed through a clearing member; 20. local firm shall mean a firm dealing only for its own account on a financial-futures or options exchange or for the accounts of or making a price to other members of the same exchange and guaranteed by a clearing member of the same exchange. Responsibility for ensuring the performance of contracts entered into by such a firm must be assumed by a clearing member of the same exchange, and such contracts must be taken into account in the calculation of the clearing member's overall capital requirements so long as the local firm's positions are entirely separate from those of the clearing member; 21. delta shall mean the expected change in an option price as a proportion of a small change in the price of the instrument underlying the option; 22. for the purposes of paragraph 4 of Annex I, long position shall mean a position in which an institution has fixed the interest rate it will receive at some time in the future, and short position shall mean a position in which it has fixed the interest rate it will pay at some time in the future; 23. own funds shall mean own funds as defined in Directive 89/299/EEC. This definition may, however, be amended in the circumstances described in Annex V; 24. initial capital shall mean items 1 and 2 of Article 2 (1) of Directive 89/299/EEC; 25. original own funds shall mean the sum of items 1, 2 and 4, less the sum of items 9, 10 and 11 of Article 2 (1) of Directive 89/299/EEC; 26. capital shall mean own funds; 27. modified duration shall be calculated using the formula set out in paragraph 26 of Annex I. INITIAL CAPITAL Article 3 1. Investment firms which hold clients' money and/or securities and which offer one or more of the following services shall have initial capital of ECU 125 000: - the reception and transmission of investors' orders for financial instruments, - the execution of investors' orders for financial instruments, - the management of individual portfolios of investments in financial instruments, provided that they do not deal in any financial instruments for their own account or underwrite issues of financial instruments on a firm commitment basis. The holding of non-trading-book positions in financial instruments in order to invest own funds shall not be considered as dealing for the purposes set out in the first paragraph or for the purposes of paragraph 2. The competent authorities may, however, allow an investment firm which executes investors' orders for financial instruments to hold such instruments for its own account if: - such positions arise only as a result of the firm's failure to match investors' orders precisely, - the total market value of all such positions is subject to a ceiling of 15 % of the firm's initial capital, - the firm meets the requirements imposed in Articles 4 and 5, and - such positions are incidental and provisional in nature and strictly limited to the time required to carry out the transaction in question. 2. Member States may reduce the amount referred to in paragraph 1 to ECU 50 000 where a firm is not authorized to hold clients' money or securities, to deal for its own account, or to underwrite issues on a firm commitment basis. 3. All other investment firms shall have initial capital of ECU 730 000. 4. The firms referred to in the second and third indents of Article 2 (2) shall have initial capital of ECU 50 000 in so far as they benefit from freedom of establishment or provide services under Articles 14 or 15 of Directive 93/22/EEC. 5. Notwithstanding paragraphs 1 to 4, Member States may continue the authorization of investment firms and firms covered by paragraph 4 in existence before this Directive is applied the own funds of which are less than the initial capital levels specified for them in paragraphs 1 to 4. The own funds of such firms shall not fall below the highest reference level calculated after the date of notification of this Directive. That reference level shall be the average daily level of own funds calculated over a six-month period preceding the date of calculation. It shall be calculated every six months in respect of the corresponding preceding period. 6. If control of a firm covered by paragraph 5 is taken by a natural or legal person other than the person who controlled it previously, the own funds of that firm must attain at least the level specified for it in paragraphs 1 to 4, except in the following situations: (i) in the case of the first transfer by inheritance after the application of this Directive, subject to the competent authorities' approval, for not more than 10 years after that transfer; (ii) in the case of a change in the composition of a partnership, as long as at least one of the partners at the date of the application of this Directive remains in the partnership, for not more than 10 years after the date of the application of this Directive. 7. In certain specific circumstances and with the consent of the competent authorities, however, in the event of a merger of two or more investment firms and/or firms covered by paragraph 4, the own funds of the firm produced by the merger need not attain the level specified in paragraphs 1 to 4. Nevertheless, during any period when the levels specified in paragraphs 1 to 4 have not been attained, the own funds of the new firm may not fall below the merged firms' total own funds at the time of the merger. 8. The own funds of investment firms and firms covered by paragraph 4 may not fall below the level specified in paragraphs 1 to 5 and 7. If they do, however, the competent authorities may, where the circumstances justify it, allow such firms a limited period in which to rectify their situations or cease their activities. PROVISIONS AGAINST RISKS Article 4 1. The competent authorities shall require institutions to provide own funds which are always more than or equal to the sum of: (i) the capital requirements, calculated in accordance with Annexes I, II and VI, for their trading-book business; (ii) the capital requirements, calculated in accordance with Annex III, for all of their business activities; (iii) the capital requirements imposed in Directive 89/647/EEC for all of their business activities, excluding both their trading-book business and their illiquid assets it they are deducted from own funds under paragraph 2 (d) of Annex V; (iv) the capital requirements imposed in paragraph 2. Irrespective of the amount of the capital requirement referred to in (i) to (iv) the own-funds requirement for investment firms shall never be less than the amount prescribed in Annex IV. 2. The competent authorities shall require institutions to cover the risks arising in connection with business that is outside the scope of both this Directive and Directive 89/647/EEC and considered to be similar to the risks covered by those Directives by adequate own funds. 3. If the own funds held by an institution fall below the amount of the own funds requirement imposed in paragraph 1, the competent authorities shall ensure that the institution in question takes appropriate measures to rectify its situation as quickly as possible. 4. The competent authorities shall require institutions to set up systems to monitor and control the interest-rate risk on all of their business, and those systems shall be subject to overview by the competent authorities. 5. Institutions shall be required to satisfy their competent authorities that they employ systems which can calculate their financial positions with reasonable accuracy at any time. 6. Notwithstanding paragraph 1, the competent authorities may allow institutions to calculate the capital requirements for their trading-book business in accordance with Directive 89/647/EEC rather than in accordance with Annexes I and II to this Directive provided that: (i) the trading-book business of such institutions does not normally exceed 5 % of their total business; (ii) their total trading-book positions do not normally exceed ECU 15 million; and (iii) the trading-book business of such institutions never exceeds 6 % of their total business and their total trading-book positions never exceed ECU 20 million. 7. In order to calculate the proportion that trading-book business bears to total business as in paragraph 6 (i) and (iii), the competent authorities may refer either to the size of the combined on- and off-balance-sheet business, to the profit and loss account or to the own funds of the institutions in question, or to a combination of those measurements. When the size of on- and off-balance-sheet business is assessed, debt instruments shall be valued at their market prices or their principal values, equities at their market prices and derivatives according to the nominal or market values of the instruments underlying them. Long positions and short positions shall be summed regardless of their signs. 8. If an institution should happen for more than a short period to exceed either or both of the limits imposed in paragraph 6 (i) and (ii) or to exceed either or both of the limits imposed in paragraph 6 (iii), it shall be required to meet the requirements imposed in Article 4 (1) (i) rather than those of Directive 89/647/EEC in respect of its trading-book business and to notify the competent authority. MONITORING AND CONTROL OF LARGE EXPOSURES Article 5 1. Institutions shall monitor and control their large exposures in accordance with Directive 92/121/EEC. 2. Notwithstanding paragraph 1, those institutions which calculate the capital requirements for their trading-book business in accordance with Annexes I and II shall monitor and control their large exposures in accordance with Directive 92/121/EEC subject to the modifications laid down in Annex VI to this Directive. VALUATION OF POSITIONS FOR REPORTING PURPOSES Article 6 1. Institutions shall mark to market their trading books on a daily basis unless they are subject to Article 4 (6). 2. In the absence of readily available market prices, for example in the case of dealing in new issues on the primary markets, the competent authorities may waive the requirement imposed in paragraph 1 and require institutions to use alternative methods of valuation provided that those methods are sufficiently prudent and have been approved by competent authorities. SUPERVISION ON A CONSOLIDATED BASIS Article 7 General principles 1. The capital requirements imposed in Articles 4 and 5 for institutions which are neither parent undertakings nor subsidiaries of such undertakings shall be applied on a solo basis. 2. The requirements imposed in Articles 4 and 5 for: - any institution which has a credit institution within the meaning of Directive 92/30/EEC, an investment firm or another financial institution as a subsidiary or which holds a participation in such an entity, and - any institution the parent undertaking of which is a financial holding company shall be applied on a consolidated basis in accordance with the methods laid down in the abovementioned Directive and in paragraphs 7 to 14 of this Article. 3. When a group covered by paragraph 2 does not include a credit institution, Directive 92/30/EEC shall apply, subject to the following adaptations: - financial holding company shall mean a financial institution the subsidiary undertakings of which are either exclusively or mainly investment firms or other financial institutions one at least of which is an investment firm, - mixed-activity holding company shall mean a parent undertaking, other than a financial holding company or an investment firm, the subsidiaries of which include at least one investment firm, - competent authorities shall mean the national authorities which are empowered by law or regulation to supervise investment firms, - every reference to credit institutions shall be replaced by a reference to investment firms, - the second subparagraph of Article 3 (5) of Directive 92/30/EEC shall not apply, - in Articles 4 (1) and (2) and 7 (5) of Directive 92/30/EEC each reference to Directive 77/780/EEC shall be replaced by a reference to Directive 93/22/EEC, - for the purposes of Articles 3 (9) and 8 (3) of Directive 92/30/EEC the references to the Banking Advisory Committee shall be substituted by references to the Council and the Commission, - the first sentence of Article 7 (4) of Directive 92/30/EEC shall be replaced by the following: 'Where an investment firm, a financial holding company or a mixed-activity holding company controls one or more subsidiaries which are insurance companies, the competent authorities and the authorities entrusted with the public task of supervising insurance undertakings shall cooperate closely'. 4. The competent authorities required or mandated to exercise supervision of groups covered by paragraph 3 on a consolidated basis may, pending further coordination on the supervision of such groups on a consolidated basis and where the circumstances justify it, waive that obligation provided that each investment firm in such a group: (i) uses the definition of own funds given in paragraph 9 of Annex V; (ii) meets the requirements imposed in Articles 4 and 5 on a solo basis; (iii) sets up systems to monitor and control the sources of capital and funding of all other financial institutions within the group. 5. The competent authorities shall require investment firms in a group which has been granted the waiver provided for in paragraph 4 to notify them of those risks, including those associated with the composition and sources of their capital and funding, which could undermine their financial positions. If the competent authorities then consider that the financial positions of those investment firms is not adequately protected, they shall require them to take measures including, if necessary, limitations on the transfer of capital from such firms to group entities. 6. Where the competent authorities waive the obligation of supervision on a consolidated basis provided for in paragraph 4 they shall take other appropriate measures to monitor the risks, namely large exposures, of the whole group, including any undertakings not located in a Member State. 7. Member States may waive the application of the requirements imposed in Articles 4 and 5, on an individual or subconsolidated basis, to an institution which, as a parent undertaking, is subject to supervision on a consolidated basis, and to any subsidiary of such an institution which is subject to their authorization and supervision and is included in the supervision on a consolidated basis of the institution which is its parent company. The same right of waiver shall be granted where the parent undertaking is a financial holding company which has its head office in the same Member State as the institution, provided that it is subject to the same supervision as that exercised over credit institutions or investment firms, and in particular the requirements imposed in Articles 4 and 5. In both cases, if the right of waiver is exercised measures must be taken to ensure the satisfactory allocation of own funds within the group. 8. Where an institution the parent undertaking of which is an institution has been authorized and is situated in another Member State, the competent authorities which granted that authorization shall apply the rules laid down in Articles 4 and 5 to that institution on a individual or, where appropriate, a subconsolidated basis. 9. Notwithstanding paragraph 8, the competent authorities responsible for authorizing the subsidiary of a parent undertaking which is an institution may, by a bilateral agreement, delegate their responsibility for supervising the subsidiary's capital adequacy and large exposures to the competent authorities which authorized and supervise the parent undertaking. The Commission must be kept informed of the existence and content of such agreements. It shall forward such information to the competent authorities of the other Member States and to the Banking Advisory Committee and to the Council, except in the case of groups covered by paragraph 3. Calculating the consolidated requirements 10. Where the rights of waiver provided for in paragraphs 7 and 9 are not exercised, the competent authorities may, for the purpose of calculating the capital requirements set out in Annex I and the exposures to clients set out in Annex VI on a consolidated basis, permit net positions in the trading book of one institution to offset positions in the trading book of another institution according to the rules set out in Annexes I and VI respectively. In addition, they may allow foreign-exchange positions subject to Annex III in one institution to offset foreign-exchange positions subjet to Annex III in another institution in accordance with the rules set out in Annex III. 11. The competent authorities may also permit offsetting of the trading book and of the foreign-exchange positions of undertakings located in third countries, subject to the simultaneous fulfilment of the following conditions: (i) those undertakings have been authorized in a third country and either satisfy the definition of credit institution given in the first indent of Article 1 of Directive 77/780/EEC or are recognized third-country investment firms; (ii) such undertakings comply, on a solo basis, with capital adequacy rules equivalent to those laid down in this Directive; (iii) no regulations exist in the countries in question which might significantly affect the transfer of funds within the group. 12. The competent authorities may also allow the offsetting provided for in paragraph 10 between institutions within a group that have been authorized in the Member State in question, provided that: (i) there is a satisfactory allocation of capital within the group; (ii) the regulatory, legal or contractual framework in which the institutions operate is such as to guarantee mutual financial support within the group. 13. Furthermore, the competent authorities may allow the offsetting provided for in paragraph 10 between institutions within a group that fulfil the conditions imposed in paragraph 12 and any institution included in the same group which has been authorized in another Member State provided that that institution is obliged to fulfil the capital requirements imposed in Articles 4 and 5 on a solo basis. Definition of consolidated own funds 14. In the calculation of own funds on a consolidated basis Article 5 of Directive 89/299/EEC shall apply. 15. The competent authorities responsible for exercising supervision on a consolidated basis may recognize the validity of the specific own-funds definitions applicable to the institutions concerned under Annex V in the calculation of their consolidated own funds. REPORTING REQUIREMENTS Article 8 1. Member States shall require that investment firms and credit institutions provide the competent authorities of their home Member States with all the information necessary for the assessment of their compliance with the rules adopted in accordance with this Directive. Member States shall also ensure that institutions' internal control mechanisms and administrative and accounting procedures permit the verification of their compliance with such rules at all times. 2. Investment firms shall be obliged to report to the competent authorities in the manner specified by the latter at least once every month in the case of firms covered by Article 3 (3), at least once every three months in the case of firms covered by Article 3 (1) and at least once every six months in the case of firms covered by Article 3 (2). 3. Notwithstanding paragraph 2, investment firms covered by Article 3 (1) and (3) shall be required to provide the information on a consolidated or subconsolidated basis only once every six months. 4. Credit institutions shall be obliged to report in the manner specified by the competent authorities as often as they are obliged to report under Directive 89/647/EEC. 5. The competent authorities shall oblige institutions to report to them immediately any case in which their counterparties in repurchase and reverse repurchase agreements or securities-lending and securities-borrowing transactions default on their obligations. The Commission shall report to the Council on such cases and their implications for the treatment of such agreements and transactions in this Directive not more than three years after the date referred to in Article 12. Such reports shall also describe the way that institutions meet those of conditions (i) to (v) in Article 2 (6) (b) that apply to them, in particular that referred to in condition (v). Furthermore it shall give details of any changes in the relative volume of institutions' traditional lending and their lending through reverse repurchase agreements and securities-borrowing transactions. If the Commission concludes on the basis of this report and other information that further safeguards are needed to prevent abuse it shall make appropriate proposals. COMPETENT AUTHORITIES Article 9 1. Member States shall designate the authorities which are to carry out the duties provided for in this Directive. They shall inform the Commission thereof, indicating any division of duties. 2. The authorities referred to in paragraph 1 must be public authorities or bodies officially recognized by national law or by public authorities as part of the supervisory system in operation in the Member State concerned. 3. The authorities concerned must be granted all the powers necessary for the performance of their tasks, and in particular that of overseeing the constitution of trading books. 4. The competent authorities of the various Member States shall collaborate closely in the performance of the duties provided for in this Directive, particularly when investment services are provided on a services basis or through the establishment of branches in one or more Member States. They shall on request supply one another with all information likely to facilitate the supervision of the capital adequacy of investment firms and credit institutions, in particular the verification of their compliance with the rules laid down in this Directive. Any exchange of information between competent authorities which is provided for in this Directive in respect of investment firms shall be subject to the obligation of professional secrecy imposed in Article 25 of Directive 93/22/EEC and, as regards credit institutions, to the obligation imposed in Article 12 of Directive 77/780/EEC, as amended by Directive 89/646/EEC. Article 10 Pending adoption of a further Directive laying down provisions for adapting this Directive to technical progress in the areas specified below, the Council shall, acting by qualified majority on a proposal from the Commission, in accordance with Decision 87/373/EEC, adopt those adaptations which may be necessary, as follows: - clarification of the definitions in Article 2 in order to ensure uniform application of this Directive throughout the Community, - clarification of the definitions in Article 2 to take account of developments on financial markets, - alteration of the amounts of initial capital prescribed in Article 3 and the amount referred to in Article 4 (6) to take account of developments in the economic and monetary field, - the alignment of terminology on and the framing of definitions in accordance with subsequent acts on institutions and related matters. TRANSITIONAL PROVISIONS Article 11 1. Member States may authorize investment firms subject to Article 30 (1) of Directive 93/22/EEC the own funds of which are on the day of the application of this Directive lower than the levels specified in Article 3 (1) to (3) of this Directive. Thereafter, however, the own funds of such investment firms must fulfil the conditions laid down in Article 3 (5) to (8) of this Directive. 2. Notwithstanding paragraph 14 of Annex I, Member States may set a specific-risk requirement for any bonds assigned a weighting of 10 % under Article 11 (2) of Directive 89/647/EEC equal to half the specific-risk requirement for a qualifying item with the same residual maturity as such a bond. FINAL PROVISIONS Article 12 1. Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive by the date fixed in the second paragraph of Article 31 of Directive 93/22/EEC. They shall forthwith inform the Commission thereof. When Member States adopt these provisions they shall include a reference to this Directive or add such a reference on the occasion of their official publication. The manner in which such references are to be made shall be laid down by the Member States. 2. Member States shall communicate to the Commission the main provisions of national law which they adopt in the field covered by this Directive. Article 13 The Commission shall as soon as possible submit to the Council proposals for capital requirements in respect of commodities trading, commodity derivatives and units of collective-investment undertakings. The Council shall decide on the Commission's proposals no later than six months before the date of application of this Directive. REVIEW CLAUSE Article 14 Within three years of the date referred to in Article 12, acting on a proposal from the Commission, the Council shall examine and, if necessary, revise this Directive in the light of the experience acquired in applying it, taking into account market innovation and, in particular, developments in international fora of regulatory authorities. Article 15 This Directive is addressed to the Member States.

31993L0012

1993

Council Directive 93/12/EEC of 23 March 1993 relating to the sulphur content of certain liquid fuels 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), In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas in order to improve air quality with regard to sulphur dioxide and other emissions, the Community has to take measures to reduce progressively the sulphur content of gas oil used for self-propelling vehicles, including aircraft and vessels, and for heating, industrial and marine purposes; Whereas, under Article 2 (1) and Article 5 (1) of Directive 75/716/EEC (4), the provisions in force in the Member States lay down two limits with respect to the sulphur content of liquid fuels; whereas these provisions differ from one Member State to another; Whereas these differences oblige Community oil companies to adjust the maximum sulphur content of their products, depending on which Member State is being supplied; whereas such differences thus constitute a barrier to trade in these products, thereby directly affecting the establishment and functioning of the single market; Whereas, in addition, Article 6 of Directive 75/716/EEC provides that in the light of any new information available the Commission is to submit a report to the Council accompanied by an appropriate proposal with a view to the establishment of a single value; Whereas successive action programmes of the European Communities on the environment (5) stress the importance of preventing and reducing air pollution; Whereas fuel quality plays an important role in reducing air pollution by vehicle eshaust emissions; Whereas, in addition, by virtue of Decision 81/462/EEC (6) the Community is a contracting party to the Convention on long-range transboundary air pollution, which provides in particular for the development of strategies and policies to limit and, as far as possible, gradually reduce and prevent air pollution; Whereas reducing the sulphur content of certain liquid fuels serves to further one of the Community's objectives, which is to preserve, protect and improve the quality of the environment and to contribute towards protecting human health, by rectifying environmental damage at source; Whereas, in accordance with Directive 75/716/EEC, several Member States have already fixed a value of 0,2 % by weight; Whereas Member States must take steps to ensure that diesel fuels of a maximum sulphur content of 0,05 % by weight are gradually made available; Whereas, in order to attain the particulate emission levels set in specific Community Directives, the sulphur content of diesel fuels placed on the market within the Community may not exceed 0,2 % by weight as from 1 October 1994 and 0,05 % by weight as from 1 October 1996; whereas the Member States must take appropriate measures to achieve that objective; Whereas the increasing use of gas oil for motor vehicles implies further efforts with regard to the quality of diesel fuel, in order to limit the adverse effects of such use on air quality; whereas setting a maximum sulphur content of 0,05 % by weight to apply from 1 October 1996 for diesel fuel allows the industries concerned sufficient time to make the technical adjustments required; Whereas the other uses of gas oils and medium oils require an effort to be made to reduce air pollution, wherein account should be taken of their contribution having regard to air quality improvement and environmental costs and benefits; whereas the Commission should submit to the Council, which will take a decision thereon by 31 July 1994 at the latest, a proposal introducing, by 1 October 1999 at the latest, a lower limit for the sulphur content and setting new limit values for aviation kerosenes; Whereas a sudden change in crude oil supplies leading to an increase in average sulphur content may, in view of available desulphurization capacity, jeopardize supplies to consumers in a Member State; whereas it would therefore seem advisable to authorize that Member State to derogate under certain conditions from the sulphur content limits laid down in respect of its own market; Whereas the introduction of a low sulphur content level in marine gas oils for sea-going ships raises specific technical and economic problems for Greece; whereas a derogation of limited duration in favour of Greece should not depress trade in marine gas oils since Greek refinery installations currently cover no more than domestic demand for gas oils and medium oils; whereas exports for final combustion from Greece to another Member State must comply with the provisions of the Directive applicable in that Member State; whereas Greece could be granted a five-year derogation before introducing marine gas oils with the required sulphur content; whereas this period will end on 30 September 1999; Whereas spot checks should be carried out to ascertain the sulphur content of gas oils and medium oils placed on the market; whereas for this purpose provision should be made for a uniform method based on the best available technology, Article 1 1. For the purposes of this Directive: (a) 'gas oil' means any petroleum product falling under CN code 2710 00 69, or any petroleum product which, by reason of its distillation limits, falls within the category of middle distillates intended for use as fuel and of which at least 85 % by volume, including distillation losses, distils at 350° C; (b) 'diesel fuels' means gas oils used for self-propelling vehicles as referred to in Directive 70/220/EEC (7) and Directive 88/77/EEC (8). 2. This Directive shall not apply to gas oils: - contained in the fuel tanks of vessels, aircraft or motor vehicles crossing a frontier between a third country and a Member State; - intended for processing prior to final combustion. Article 2 1. Member States shall, in order to reach the particulate emission levels laid down in specific Community Directives, prohibit the marketing of diesel fuels in the Community if their sulphur compound content, expressed in sulphur (hereinafter 'sulphur content'), exceeds: - 0,2 % by weight as from 1 October 1994, - 0,05 % by weight as from 1 October 1996. Member States shall take steps to ensure that the diesel fuels referred to in the first paragraph with a sulphur content not exceeding 0,05 % by weight are gradually made available. 2. Member States shall prohibit the marketing in the Community of gas oils other than, or used for purposes other than, those referred to in paragraph 1 with the exception of aviation kerosene, as from 1 October 1994, if their sulphur content exceeds 0,2 % by weight. Before 1 January 1994, the Commission shall indicate, in a report to the Council, what progress has been made in controlling sulphur dioxide emissions. At the same time it shall submit to the Council a proposal, in the more general framework of the policy to improve air quality, for transition to a second phase, prescribing a lower limit by 1 October 1999 at the latest, and setting new limit values for aviation kerosene. The Council shall act by a qualified majority by 31 July 1994 at the latest. 3. If, as the result of a sudden change in the supply of crude oil or petroleum products, it becomes difficult for a Member State to apply the limit on the maximum sulphur content of gas oil, that Member State shall inform the Commission thereof. The Commission may authorize a higher limit to be applicable within the territory of that Member State for a period not exceeding six months, and shall notify its decision to the Council. Any Member State may contest that Decision before the Council within one month. The Council, acting by a qualified majority, may adopt a different decision within two months. By way of derogation the Government of Greece may, up to 30 September 1999, authorize marketing of gas oil for marine use with a sulphur content in excess of 0,2 % by weight. Article 3 No Member State may, as from the dates of application laid down in Article 2 (1) and (2), prohibit, restrict or prevent the placing on the market of gas oils on the grounds of their sulphur content, if those gas oils comply with the requirements of this Directive. Article 4 1. Member States shall take all necessary measures to check by sampling the sulphur content of gas oils which are placed on the market. 2. The reference method adopted for determining the sulphur content of gas oils which are placed on the market shall be that defined by ISO method 8754. The statistical interpretation of the results of the checks made to determine the sulphur content of the gas oils placed on the market shall be made in accordance with ISO standard 4259 (1979 edition). Article 5 As from 1 October 1994, Directive 75/716/EEC shall be replaced by this Directive. Article 6 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 October 1994. 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. Article 7 This Directive is addressed to the Member States.

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Commission Directive 93/17/EEC of 30 March 1993 determining Community grades of basic seed potatoes, together with the conditions and designations applicable to such grades Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 66/403/EEC of 14 June 1966 on the marketing of seed potatoes (1), as last amended by Commission Directive 93/3/EEC (2), and in particular Article 3 (3) thereof, Whereas, in order to implement, in an area without internal frontiers in which the free movement of goods is ensured in accordance with the provisions of the Treaty, the provisions of Directive 66/403/EEC in respect of the marketing of seed potatoes in all or part of the territory of one or more Member States satisfying more stringent measures than those provided for in Annexes I and II to that Directive, it is appropriate to determine Community grades of basic seed potatoes, as well as the conditions and designations applicable to such grades; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry, Article 1 1. Community grades of basic seed potatoes are hereby determined. Seed potatoes eligible for these grades are those which qualify for the official certification as 'basic seed potatoes' in accordance with the provisions of Article 2 (1) (a) of Directive 66/403/EEC, and which moreover satisfy the conditions specified in paragraph 2, and which have been found on official examination to satisfy those conditions. 2. The following are the conditions referred to in paragraph 1: (a) the plant health conditions laid down in: - Council Directive 69/464/EEC (3), - Council Directive 69/465/EEC (4), - Council Directive 77/93/EEC (5), - Council Directive 80/665/EEC (6); (b) the seed potatoes shall derive from material satisfying the conditions laid down in Annex I, and satisfy the additional or more stringent conditions laid down in Annex II. Article 2 1. The designation of the Community grades of basic seed potatoes shall be: (a) 'EEC grade 1' in cases where the conditions laid down in Annex I, other than point 3.3 (b) thereof, and Annex II (1) are met; or (b) 'EEC grade 2' in cases where the conditions laid down in Annex I, other than point 3.3 (a) thereof, and Annex II (2) are met; or (c) 'EEC grade 3' in cases where the conditions laid down in Annex I other than point 3.3 (a) thereof, and Annex II (3) are met. The designation shall be indicated on the official label provided for in Annex III to Directive 66/403/EEC, under the heading 'grade'. 2. Member States shall inform the Commission of the extent to which they apply the respective Community grades in certifying their own production. Article 3 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than the date provided for the implementation of Council Directive 91/683/EEC (7). They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law they adopt in the field covered by this Directive. Article 4 This Directive is addressed to the Member States.

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Council Directive 93/15/EEC of 5 April 1993 on the harmonization of the provisions relating to the placing on the market and supervision of explosives for civil uses 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 Article 8a of the Treaty provides that the internal market must be established not later than 31 December 1992; whereas the internal market is to comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured in accordance with the provisions of the Treaty; Whereas Article 100a (3) of the Treaty provides that the Commission, in its proposals concerning safety, will take as a base a high level of protection; Whereas the free movement of goods presupposes that certain basic conditions are fulfilled; whereas, in particular, the free movement of explosives presupposes harmonization of laws on the placing of explosives on the market; Whereas explosives for civil uses are covered by detailed national regulations, mainly in respect of safety and security requirements; whereas such national regulations provide, in particular, that marketing authorizations be granted only where explosives have satisfactorily undergone a series of tests; Whereas harmonization of provisions governing the placing of such explosives on the market presupposes that divergent national rules will be harmonized in order to ensure the free movement of these products without lowering optimum levels of safety and security; Whereas this Directive defines only the essential requirements which must be met by explosives conformity tests; whereas, in order to facilitate the process of demonstrating compliance with the essential requirements, it would be very useful to process standards harmonized at European level concerning, inter alia, methods for testing explosives; whereas such standards do not exist at present; Whereas standards harmonized at European level are drawn up by private bodies and must retain their status as non-mandatory text; whereas, in this connection, the European Committee for Standardization (CEN) has been recognized as one of the two bodies competent to adopt harmonized standards in accordance with the general guidelines for cooperation between the Commission and CEN and Cenelec, ratified on 13 November 1984; whereas, for the purposes of this Directive, 'harmonized standard' means a text setting out technical specifications adopted by CEN under a mandate conferred by the Commission, in accordance with Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations(4) and in keeping with the abovementioned general guidelines; Whereas the Council, in its Decision 90/683/EEC of 13 December 1990 concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonization directives(5) , introduced harmonized means of applying procedures for conformity assessment; whereas the application of these modules to explosives will make it possible to determine the responsibility of manufacturers and of bodies responsible for applying procedures for conformity assessment by taking account of the nature of the explosives concerned; Whereas, as regards safety, the rules concerning the transport of explosives are covered by international conventions and agreements; whereas, at international level, there are United Nations recommendations on the transport of dangerous goods (including explosives), the scope of which extends beyond the Community framework; whereas, in consequence, this Directive does not concern the transport rules; Whereas, pyrotechnical articles require appropriate measures to ensure the protection of consumers and the safety of the public; whereas an additional directive is planned in this field; Whereas the definition of the products covered by this Directive should be based on the definition of such products as set out in the abovementioned recommendations; Whereas the scope of this Directive covers ammunition, but only as regards the rules governing controls on transfers and the associated arrangements; whereas, since ammunition is transferred under conditions similar to those under which arms are transferred, transfers of ammunition should be governed by provisions similar to those applicable to arms, as set out in Directive 91/477/EEC of 18 June 1991 on control of the acquisition and possession of weapons(6) ; Whereas the health and safety of workers producing or using explosives must also be protected; whereas an additional directive is in the course of preparation covering, inter alia, the health and safety of workers engaged in activities relating to the manufacture, storage and use of explosives; Whereas it is appropriate in the case of a serious threat to, or attack on, public safety by reason of the illicit possession or use of explosives or ammunition falling within this Directive, to allow Member States to derogate, under certain conditions, from the provisions of this Directive with regard to transfer; Whereas, finally, it is essential to establish administrative cooperation mechanisms; whereas it is appropriate in this connection for the competent authorities to base their approach on Council Regulation (EEC) No 1468/81 of 19 May 1981 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs or agricultural matters(7) ; Whereas this Directive does not affect the power of Member States to take measures with a view to preventing illegal trade in explosives and ammunition, CHAPTER I General provisions Article 1 1. This Directive shall apply to explosives as defined in paragraph 2. 2. 'Explosives' shall mean the materials and articles considered to be such in the United Nations recommendations on the transport of dangerous goods and falling within Class 1 of those recommendations. 3. This Directive shall not apply to: - explosives, including ammunition, intended for use, in accordance with national law, by the armed forces or the police, - pyrotechnical articles, - ammunition, except as provided in Articles 10, 11, 12, 13, 17, 18 and 19. 4. For the purposes of this Directive: - 'United Nations recommendations' shall mean the recommendations laid down by the United Nations Committee of Experts on the Transport of Dangerous Goods, as published in the UN (Orange Book) and as amended by the date when this Directive is adopted, - 'safety' shall mean the prevention of accidents and, where prevention fails, the containment of their effects, - 'security' shall mean the prevention of use contrary to law and order, - 'dealer' shall mean any natural or legal person whose occupation consists wholly or partly in the manufacture, trade, exchange, hiring out, repair or conversion of fire arms and ammunition, - 'approval' shall mean the decision taken to allow envisaged transfers of explosives within the Community, - 'undertaking in the explosives sector' shall mean any natural or legal person possessing a licence or authorization which entitles him to engage in the manufacture, storage, use, transfer or trade in explosives, - 'placing on the market' shall mean any first disposal against payment or free of charge of explosives covered by this Directive with a view to their distribution and/or use on the Community market, - 'transfer' shall mean any physical movement of explosives within Community territory apart from movements within one and the same site. 5. This Directive shall not prevent Member States from designating certain substances not covered by this Directive as explosives under national law or regulations. CHAPTER II Harmonization of laws relating to explosives Article 2 1. Member States may not prohibit, restrict or hinder the placing on the market of explosives which fall within the scope of this Directive and which satisfy the requirements of this Directive. 2. Member States shall take the necessary measures to ensure that explosives falling within the scope of this Directive may be placed on the market only if they comply with all the provisions of this Directive, are provided with the CE marking described in Article 7 and their conformity has assessed in accordance with the procedures referred to in Annex II. 3. Where explosives falling within the scope of this Directive are subject to other Directives which cover other aspects and prescribe the fixing of the CE marking, this marking shall indicate that the abovementioned products are also presumed to conform to the provisions of these other directives which apply to them. Article 3 Explosives falling within the scope of this Directive must comply with the essential safety requirements set out in Annex I which apply to them. Article 4 1. Member States shall consider explosives falling within the scope of this Directive which comply with the relevant national standards transposing the harmonized standards the references of which have been published in the Official Journal of the European Communities to be in conformity with the essential safety requirements referred to in Article 3. Member States shall publish the references of the national standards transposing those harmonized standards. 2. The Commission will give specific details of the work conducted in the field of harmonized standards in the framework of the report submitted to the European Parliament and the Council on the application of Directive 83/189/EEC and provided for in Article 11 (2) of that Directive. Article 5 Where a Member State or the Commission considers that the harmonized standards referred to in Article 4 do not fully satisfy the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the Standing Committee set up by Directive 83/189/EEC, giving its reasons. The Committee shall deliver its opinion without delay. In the light of the Committee's opinion the Commission shall inform the Member States of the measures to be taken regarding the standards and the publication referred to in Article 4. Article 6 1. The procedures for the attestation of the conformity of explosives shall be either: (a) EC type examination (Module B) referred to in Annex II (1), and, at the choice of the manufacturer, either: - the type conformity (Module C) referred to in Annex II (2), - or the production quality assurance procedure (Module D) referred to in Annex II (3), - or the product quality assurance procedure (Module E) referred to in Annex II (4), - or the product verification (Module F) referred to in Annex II (5); or (b) the unit verification (Module G) referred to in Annex II (6). 2. Member States shall inform the Commission and the other Member States of the bodies which they have appointed to carry out the procedures for assessing the conformity referred to above together with the specific tasks which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission. The Commission shall publish in the Official Journal of the European Communities a list of the notified bodies and their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date. Member States shall apply the minimum criteria set out in Annex III for the assessment of bodies of which the Commission is to be notified. Bodies which meet the assessment criteria laid down by the relevant harmonized standards shall be presumed to satisfy the relevant minimum criteria. A Member State which hase notified the Commission of a given body shall withdraw the notification if it discovers that that body no longer meets the criteria referred to in the second subparagraph. It shall immediately inform the other Member States and the Commission accordingly. Article 7 1. The CE marking of conformity shall be affixed in such a way as to be visible, easily legible and indelible on the explosives themselves or, if this is not possible, on an identification plate attached thereto or, in the last resort, if the first two methods cannot be used, on the packaging. The identification plate must be so designed as to make its reuse impossible. The model to be used for the CE marking shall be that reproduced in Annex IV. 2. It shall be prohibited to affix on explosives any mark or inscription which may confuse third persons as to the meaning and style of writing of the CE marking. Any other mark may be affixed on explosives provided the visiblility and legibility of the CE marking is not impaired. 3. Without prejudice to the provisions of Article 8: (a) where a Member State establishes that the CE marking has been unduly affixed, the manufacturer, his agent or, failing these, the person responsible for placing the product in question on the Community market shall be obliged to restore the product to conformity with regard to the provisions on marking and end the infringement under conditions imposed by the Member States; (b) where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 8. Article 8 1. Where a Member State establishes that an explosive bearing CE conformity marking and being used for its intended purpose may compromise safety, it shall take all interim measures necessary to withdraw the explosive from the market or prohibit its being placed on the market or its freedom of movement. The Member State shall immediately inform the Commission of such measures, indicating the reasons for its measures and, in particular, whether non-conformity is the result of: - non-compliance with essential requirements, - incorrect application of standards, or - a shortcoming in the standards. 2. The Commission shall consult the parties concerned as soon as possible. Where the Commission establishes, after consultation, that the measures are justified, it shall immediately inform the Member State which took the initiative, as well as the other Member States. Where the Commission establishes, after consultation, that the measures are unjustified, it shall immediately inform the Member State which took the decision. In the particular case where the measures referred to in paragraph 1 are based on a shortcoming in the standards, the Commission shall first consult the parties concerned and then within two months bring the matter before the Standing Committee set up by Directive 83/189/EEC if the Member State which took the measures intends to maintain them and initiates the procedures referred to in Article 5. 3. Where CE conformity marking is borne by an explosive which does not comply with the requirements, the competent Member State shall take appropriate measures in respect of the person who affixed the marking and shall inform the Commission and the other Member States. CHAPTER III Provisions governing the supervision of transfers in the Community Article 9 1. Explosives covered by this Directive may be transferred only in accordance with the following paragraphs. 2. Controls performed pursuant to Community law or national law in the event of transfers of the explosives governed by this Article shall no longer be performed as internal frontier controls but solely as part of the normal control procedures applied in a non-discriminatory fashion throughout the territory of the Community. 3. Approval to transfer explosives shall be obtained by the consignee from the recipient competent authority. The competent authority shall verify that the consignee is legally authorized to acquire explosives and that he is in possession of the necessary licences or authorizations. The person responsible for the transfer must notify the competent authorities of the transit Member State or Member States of movements of explosives through this or these States, whose approval shall be required. 4. Where a Member State considers that there is a problem regarding the verification of the entitlement to acquire explosives referred to in paragraph 3, that Member State shall forward the available information on the subject to the Commission which will put the matter before the Committee provided for in Article 12 without delay. 5. Where the recipient competent authority approves a transfer, it shall issue to the consignee a document which includes all the information referred to in paragraph 7. Such a document must accompany the explosives until they arrive at their stated destination. It must be produced at the request of the relevant competent authorities. A copy of this document shall be retained by the consignee who shall present it for examination by the recipient competent authority, at the latter's request. 6. Where the competent authority of a Member State considers that special security requirements such as those referred to in paragraph 5 are unnecessary, explosives can be transferred on their territory or part thereof without prior provision of information within the meaning of paragraph 7. The recipient competent authority shall then grant an approval for a fixed period and liable to suspension or withdrawal at any time on the basis of a reasoned justification. The document referred to in paragraph 5, which must accompany the explosives until they arrive at their destination, shall refer solely to the abovementioned approval. 7. Where transfers of explosives must be specially supervised in order to comply with special security requirements in the territory or part of the territory of a Member State, prior to the transfer the following information shall be provided by the consignee to the recipient competent authority: - the names and addresses of the operators concerned; this information must be detailed enough to enable the operators to be contacted and confirmation to be obtained that the persons in question are legally entitled to receive the consignment, - the number and quantity of the explosives being transferred, - a full description of the explosive in question and of the means of identification, including the United Nations identification number, - where the explosives are to be placed on the market, information on compliance with conditions for placing on the market, - the means of transfer and the itinerary, - the expected dates of departure and arrrival, - where necessary, the precise points of entry to and exit from Member States. Recipient competent authorities shall examine the conditions under which the transfer may take place, with particular regard to the special security requirements. If the special security requirements are satisfied, approval for the transfer shall be granted. In the event of transit through the territory of other Member States, those States shall likewise examine and approve, in the same conditions, the particulars concerning the transfer. 8. Without prejudice to the normal checks which the Member State of departure shall carry out in its territory, at the request of the competent authorities concerned, the consignees and the operators concerned in the explosives sector shall forward to the authorities of the Member State of departure and to those of the Member State of transit all relevant information they posses concerning the transfer of explosives. 9. No supplier may transfer explosives unless the consignee has obtained the necessary authorizations for the transfer in accordance with the provisions of pargraphs 3, 5, 6 and 7. Article 10 1. Ammunition may be transferred from one Member State to another only in accordance with the procedure laid down in the following paragraphs. These provisions shall also apply to transfers of ammunition under mail-order sales. 2. Where ammunition is to be transferred to another Member State the person concerned shall, before any dispatch, communicate to the Member State in which that ammunition is located: - the names and addresses of the person selling or transferring the ammunition, of the person purchasing or acquiring the ammunition and, where appropriate, of the owner, - the adress to which the ammunition is to be consigned or transported, - the quantity of ammunition to be consigned or transported, - data making it possible to identify the ammunition and also an indication that the ammunition has undergone a check in accordance with the Convention of 1 July 1969 on the Reciprocal Recognition of Proofmarks on Small Arms, - the means of transfer, - the date of departure and the estimated date of arrival. The information referred to in the last two indents need not be supplied in the event of a transfer between dealers. The Member State shall examine the conditions under which the transfer is to be carried out, in particular with regard to security. Where the Member State authorizes such a transfer it shall issue a licence incorporating all the particulars referred to in the first subparagraph. That licence shall accompany the ammunition until it reaches its destination; it shall be produced whenever so required by the competent authorities of the Member States. 3. Each Member State may grant dealers the right to effect transfers of ammunition from its territory to a dealer established in another Member State without the prior authorization referred to in paragraph 2. To that end it shall issue an authorization valid for three years which may at any time be suspended or cancelled by reasoned decision. A document referring to that authorization must accompany the ammunition until it reaches its destination. It must be produced whenever so required by the competent authorities of the Member States. Before effecting the transfer, the dealer shall communicate to the authorities of the Member State from which the transfer is to be effected all the particulars listed in the first subparagraph of paragraph 2. 4. Each Member State shall supply the other Member States with a list of the ammunition the transfer of which to its territory may be authorized without its prior consent. Such lists of ammunition shall be communicated to dealers who have obtained approval for transferring ammunition without prior authorization under the procedure laid down in paragraph 3. 5. Each Member State shall communicate all useful information at its disposal concerning definitive transfers of ammunition to the Member State, to the territory of which such a transfer has been effected. All information that Member States receive by way of the procedures laid down in this Article shall be communicated, not later than the time of the relevant transfers, to the Member States of destination and, where appropriate, not later than the time of transfer to the Member States of transit. Article 11 By derogation from Article 9 (3), (5), (6) and (7), and from Article 10, a Member State, in case of grave threats to, or attacks upon, public security through the illicit possession or use of explosives or ammunition covered by the Directive, may take all necessary measures concerning transfers of explosives or ammunition in order to prevent such illicit possession or use. These measures shall respect the principle of proportionality. They must constitute neither a means of arbitrary discrimination nor a veiled restriction in trade between Member States. Each Member State which adopts such measures shall notify the Commission of them forthwith; the Commission shall inform the other Member States thereof. CHAPTER IV Other provisions Article 12 1. Member States shall set up information exchange networks for the implementation of Articles 9 and 10. They shall notify the other Member States and the Commission of the national authorities responsible for forwarding or receiving information and for applying the procedures referred to in the said Articles 9 and 10. 2. For the purpose of implementing this Directive, the provisions of Regulation (EEC) No 1468/81, in particular those relating to confidentiality, shall apply mutatis mutandis. Article 13 1. The Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission. The committee shall examine any matter concerning the application of this Directive raised 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 deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. The Commission shall adopt measures which shall apply immediately. However, if these measures are not in accordance with the opinion of the committee, they shall be communicated by the Commission to the Council forthwith. In that event the Commission shall defer application of the measures which it has decided for three months from the date of communication. The Council, acting by a qualified majority, may take a different decision within the period referred to in the second subparagraph. 3. The procedure laid down in paragraph 2 shall be followed in particular to take acount of any future amendments to the United Nations recommendations. Article 14 Member States shall keep at the disposal of the other Member States and the Commission updated information concerning undertakings in the explosives sector possessing licences or authorizations as referred to in Article 1 (4). Member States shall ascertain whether such undertakings possess a system for keeping track of explosives such that those holding explosives can be identified at any time. The conditions for the application of this subparagraph shall be adopted in accordance with the committee procedure provided for in Article 13. Undertakings in the explosives sector shall keep such records of their transactions as are necessary to fulfil the obligations set out in this Article. The documents referred to in this Article must be kept for at least three years after the end of the calendar year in which the recorded transaction took place, even if the undertaking has ceased trading. They must be immediately available for inspection at the request of the competent authorities. Article 15 Member States shall ensure that explosives are properly marked. Article 16 When a Member State issues a licence or authorzation for the purpose of allowing an explosives manufacturing activity to be exercised, it shall check in particular that the persons responsible are capable of complying with the technical commitments they assume. CHAPTER V Final provisions Article 17 Each Member State shall determine the penalties to be applied for infringement of the provisions adopted in implementation of this Directive. The penalties shall be sufficient to promote compliance with those provisions. Article 18 Each Member State shall adopt, in the context of its national law, the necessary measures to enable the competent authorities to seize any product coming within the scope of this Directive if there is sufficient evidence that that product will be illictly acquired, used or dealt in. Article 19 1. Member States shall bring into force the provisions necessary to comply with Articles 9, 10, 11, 12, 13 and 14 before 30 September 1993. 2. Member States shall adopt and publish before 30 June 1994 the laws, regulations and administrative provisions necessary to comply with the provisions other than those mentioned in paragraph 1. They shall forthwith inform the Commission thereof. They shall apply these provisions as from 1 January 1995. 3. When Member States adopt the provisions referred to in paragraphs 1 and 2 those provisions 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 determined by the Member States. 4. However, during the period up to 31 December 2002, Member States shall allow the placing on the markets of explosives complying with the national regulations in force in their territory before 31 December 1994. 5. Member States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive. Article 20 This Directive is addressed to the Member States.

31993L0014

1993

COUNCIL DIRECTIVE 93/14/EEC of 5 April 1993 on the braking of two or three-wheel motor vehicles Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof, Having regard to Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two or three-wheel motor vehicles (1), Having regard to the proposal from the Commission (2), In cooperation with the European Parliament (3), Having regard to the opinion of the Economic and Social Committee (4), Whereas measures should be adopted which are intended gradually to establish the internal market within a period expiring on 31 December 1992; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas, with regard to braking, in each Member State two or three-wheel vehicles must display certain technical characteristics laid down by mandatory provisions which differ from one Member State to another; whereas, as a result of their differences, such provisions constitute barriers to trade within the Community; Whereas these barriers to the establishment and operation of the internal market may be removed if the same requirements are adopted by all the Member States in place of their national rules; Whereas it is necessary to draw up harmonized requirements concerning the braking of two or three-wheel motor vehicles in order to enable the type-approval and component type-approval procedures laid down in Directive 92/61/EEC to be applied for each type of such vehicle; Whereas in order to facilitate access to the markets of non-Community countries it is necessary to establish equivalence between the requirements of this Directive and those of United Nations ECE Regulation No 78, Article 1 This Directive applies to the braking of all types of vehicle as defined in Article 1 of Directive 92/61/EEC. Article 2 The procedure for the granting of component type-approval in respect of the braking of a type of two or three-wheel motor vehicle and the conditions governing the free movement of such vehicles shall be as laid down in Chapters II and III of Directive 92/61/EEC. Article 3 In accordance with Article 11 of Directive 92/61/EEC, equivalence between the requirements laid down in this Directive and those laid down in United Nations ECE Regulation No 78 (E/ECE/324 and E/ECE(TRANS/505 REV 1 ADD 77 of 20 October 1988) is hereby acknowledged. The authorities of the Member States which grant component type-approval shall accept approvals granted in accordance with the requirements of the abovementioned Regulation No 78 as well as component type-approval marks as an alternative to the corresponding approvals and component type-approval marks granted in accordance with this Directive. Article 4 This Directive may be amended in accordance with Article 13 of Directive 70/156/EEC (5) in order to: — take into account any amendments to the ECE Regulation referred to in Article 3, — adapt the Annex to technical progress. Article 5 1. Member States shall adopt and publish the provisions necessary to comply with this Directive before 5 October 1994 and shall forthwith inform the Commission thereof. When the Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. From the date mentioned in the first subparagraph Member States may not, for reasons connected with braking, prohibit the initial entry into service of vehicles which conform to this Directive. They shall apply the provisions referred to in the first suparagraph as from 5 April 1995. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 6 This Directive is addressed to the Member States.

31993L0018

1993

Commission Directive 93/18/EEC of 5 April 1993 adapting for the third time to technical progress Council Directive 88/379/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (1), and in particular Article 15 thereof, Whereas Council Directive 92/32/EEC (2) amending Directive 67/548/EEC (3) for the seventh time, replaces the definition 'teratogenic' by 'toxic for reproduction' and introduces this modification into Directive 88/379/EEC; Whereas Annex VI to Directive 67/548/EEC, as last amended by Commission Directive 92/37/EEC (4), provides for new criteria and new R type phrases for the category of danger 'toxic for reproduction', as well as new criteria for the use of certain R phrases concerning the nature of particular risks attributed to dangerous substances and preparations and in particular phrases R 33 and R 64; Whereas the provisions set out in Annex I to Directive 88/379/EEC, as amended by Directive 90/492/EEC (5), should therefore be revised and supplemented; Whereas Annex II to Directive 88/379/EEC contains special labelling provisions applicable to certain preparations; whereas these special labelling provisions apply without distinction to all preparations under consideration whether or not considered dangerous within the meaning of the Directive; Whereas it is necessary to make special provisions in addition to those relating to labelling in the case of preparations which although they contain at least one substance which is dangerous are not necessarily dangerous within the meaning of Directive 88/379/EEC; Whereas the special provisions applicable to certain preparations set out in Annex II to Directive 88/379/EEC as amended by Directive 89/178/EEC (6) should therefore be revised and supplemented; Whereas the amendments to Annex II result in its restructuring featuring in particular a new presentation by chapter in order to maintain the clarity required in all legislation; Whereas Article 8a of the Treaty established an area without internal barriers in which the free circulation of goods, of persons, of services and capital is assured; Whereas, according to the scope and effects of the proposed action, the Community measures envisaged by this regulation are not only necessary but also indispendable for the attainment of the stated objectives and that these objectives cannot be achieved by Member States individually, and that furthermore their attainment at Community level is already provided for by Directive 88/379/EEC; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in Dangerous Substances and Preparations, Article 1 Annexes I and II to Directive 88/379/EEC are replaced by the Annex to this Directive. Article 2 1. Member States shall adopt and publish the provisions necessary to comply with this Directive by 1 July 1994 at the latest and shall forthwith inform the Commission thereof. 2. These provisions shall take effect by 1 July 1994 at the latest. 3. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

31993L0013

1993

COUNCIL DIRECTIVE 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 A 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 it is necessary to adopt measures with the aim of progressively establishing the internal market before 31 December 1992; whereas the internal market comprises an area without internal frontiers in which goods, persons, services and capital move freely; Whereas the laws of Member States relating to the terms of contract between the seller of goods or supplier of services, on the one hand, and the consumer of them, on the other hand, show many disparities, with the result that the national markets for the sale of goods and services to consumers differ from each other and that distortions of competition may arise amongst the sellers and suppliers, notably when they sell and supply in other Member States; Whereas, in particular, the laws of Member States relating to unfair terms in consumer contracts show marked divergences; Whereas it is the responsibility of the Member States to ensure that contracts concluded with consumers do not contain unfair terms; Whereas, generally speaking, consumers do not know the rules of law which, in Member States other than their own, govern contracts for the sale of goods or services; whereas this lack of awareness may deter them from direct transactions for the purchase of goods or services in another Member State; Whereas, in order to facilitate the establishment of the internal market and to safeguard the citizen in his role as consumer when acquiring goods and services under contracts which are governed by the laws of Member States other than his own, it is essential to remove unfair terms from those contracts; Whereas sellers of goods and suppliers of services will thereby be helped in their task of selling goods and supplying services, both at home and throughout the internal market; whereas competition will thus be stimulated, so contributing to increased choice for Community citizens as consumers; Whereas the two Community programmes for a consumer protection and information policy (4) underlined the importance of safeguarding consumers in the matter of unfair terms of contract; whereas this protection ought to be provided by laws and regulations which are either harmonized at Community level or adopted directly at that level; Whereas in accordance with the principle laid down under the heading ‘Protection of the economic interests of the consumers’, as stated in those programmes: ‘acquirers of goods and services should be protected against the abuse of power by the seller or supplier, in particular against one-sided standard contracts and the unfair exclusion of essential rights in contracts’; Whereas more effective protection of the consumer can be achieved by adopting uniform rules of law in the matter of unfair terms; whereas those rules should apply to all contracts concluded between sellers or suppliers and consumers; whereas as a result inter alia contracts relating to employment, contracts relating to succession rights, contracts relating to rights under family law and contracts relating to the incorporation and organization of companies or partnership agreements must be excluded from this Directive; Whereas the consumer must receive equal protection under contracts concluded by word of mouth and written contracts regardless, in the latter case, of whether the terms of the contract are contained in one or more documents; Whereas, however, as they now stand, national laws allow only partial harmonization to be envisaged; whereas, in particular, only contractual terms which have not been individually negotiated are covered by this Directive; whereas Member States should have the option, with due regard for the Treaty, to afford consumers a higher level of protection through national provisions that are more stringent than those of this Directive; Whereas the statutory or regulatory provisions of the Member States which directly or indirectly determine the terms of consumer contracts are presumed not to contain unfair terms; whereas, therefore, it does not appear to be necessary to subject the terms which reflect mandatory statutory or regulatory provisions and the principles or provisions of international conventions to which the Member States or the Community are party; whereas in that respect the wording ‘mandatory statutory or regulatory provisions’ in Article 1 (2) also covers rules which, according to the law, shall apply between the contracting parties provided that no other arrangements have been established; Whereas Member States must however ensure that unfair terms are not included, particularly because this Directive also applies to trades, business or professions of a public nature; Whereas it is necessary to fix in a general way the criteria for assessing the unfair character of contract terms; Whereas the assessment, according to the general criteria chosen, of the unfair character of terms, in particular in sale or supply activities of a public nature providing collective services which take account of solidarity among users, must be supplemented by a means of making an overall evaluation of the different interests involved; whereas this constitutes the requirement of good faith; whereas, in making an assessment of good faith, particular regard shall be had to the strength of the bargaining positions of the parties, whether the consumer had an inducement to agree to the term and whether the goods or services were sold or supplied to the special order of the consumer; whereas the requirement of good faith may be satisfied by the seller or supplier where he deals fairly and equitably with the other party whose legitimate interests he has to take into account; Whereas, for the purposes of this Directive, the annexed list of terms can be of indicative value only and, because of the cause of the minimal character of the Directive, the scope of these terms may be the subject of amplification or more restrictive editing by the Member States in their national laws; Whereas the nature of goods or services should have an influence on assessing the unfairness of contractual terms; Whereas, for the purposes of this Directive, assessment of unfair character shall not be made of terms which describe the main subject matter of the contract nor the quality/price ratio of the goods or services supplied; whereas the main subject matter of the contract and the price/quality ratio may nevertheless be taken into account in assessing the fairness of other terms; whereas it follows, inter alia, that in insurance contracts, the terms which clearly define or circumscribe the insured risk and the insurer's liability shall not be subject to such assessment since these restrictions are taken into account in calculating the premium paid by the consumer; Whereas contracts should be drafted in plain, intelligible language, the consumer should actually be given an opportunity to examine all the terms and, if in doubt, the interpretation most favourable to the consumer should prevail; Whereas Member States should ensure that unfair terms are not used in contracts concluded with consumers by a seller or supplier and that if, nevertheless, such terms are so used, they will not bind the consumer, and the contract will continue to bind the parties upon those terms if it is capable of continuing in existence without the unfair provisions; Whereas there is a risk that, in certain cases, the consumer may be deprived of protection under this Directive by designating the law of a non-Member country as the law applicable to the contract; whereas provisions should therefore be included in this Directive designed to avert this risk; Whereas persons or organizations, if regarded under the law of a Member State as having a legitimate interest in the matter, must have facilities for initiating proceedings concerning terms of contract drawn up for general use in contracts concluded with consumers, and in particular unfair terms, either before a court or before an administrative authority competent to decide upon complaints or to initiate appropriate legal proceedings; whereas this possibility does not, however, entail prior verification of the general conditions obtaining in individual economic sectors; Whereas the courts or administrative authorities of the Member States must have at their disposal adequate and effective means of preventing the continued application of unfair terms in consumer contracts, Article 1 1. The purpose of this Directive is to approximate the laws, regulations and administrative provisions of the Member States relating to unfair terms in contracts concluded between a seller or supplier and a consumer. 2. The contractual terms which reflect mandatory statutory or regulatory provisions and the provisions or principles of international conventions to which the Member States or the Community are party, particularly in the transport area, shall not be subject to the provisions of this Directive. Article 2 For the purposes of this Directive: (a) ‘unfair terms’ means the contractual terms defined in Article 3; (b) ‘consumer’ means any natural person who, in contracts covered by this Directive, is acting for purposes which are outside his trade, business or profession; (c) ‘seller or supplier’ means any natural or legal person who, in contracts covered by this Directive, is acting for purposes relating to his trade, business or profession, whether publicly owned or privately owned. Article 3 1. A contractual term which has not been individually negotiated shall be regarded as unfair if, contrary to the requirement of good faith, it causes a significant imbalance in the parties' rights and obligations arising under the contract, to the detriment of the consumer. 2. A term shall always be regarded as not individually negotiated where it has been drafted in advance and the consumer has therefore not been able to influence the substance of the term, particularly in the context of a pre-formulated standard contract. The fact that certain aspects of a term or one specific term have been individually negotiated shall not exclude the application of this Article to the rest of a contract if an overall assessment of the contract indicates that it is nevertheless a pre-formulated standard contract. Where any seller or supplier claims that a standard term has been individually negotiated, the burden of proof in this respect shall be incumbent on him. 3. The Annex shall contain an indicative and non-exhaustive list of the terms which may be regarded as unfair. Article 4 1. Without prejudice to Article 7, the unfairness of a contractual term shall be assessed, taking into account the nature of the goods or services for which the contract was concluded and by referring, at the time of conclusion of the contract, to all the circumstances attending the conclusion of the contract and to all the other terms of the contract or of another contract on which it is dependent. 2. Assessment of the unfair nature of the terms shall relate neither to the definition of the main subject matter of the contract nor to the adequacy of the price and remuneration, on the one hand, as against the services or goods supplies in exchange, on the other, in so far as these terms are in plain intelligible language. Article 5 In the case of contracts where all or certain terms offered to the consumer are in writing, these terms must always be drafted in plain, intelligible language. Where there is doubt about the meaning of a term, the interpretation most favourable to the consumer shall prevail. This rule on interpretation shall not apply in the context of the procedures laid down in Article 7 (2). Article 6 1. Member States shall lay down that unfair terms used in a contract concluded with a consumer by a seller or supplier shall, as provided for under their national law, not be binding on the consumer and that the contract shall continue to bind the parties upon those terms if it is capable of continuing in existence without the unfair terms. 2. Member States shall take the necessary measures to ensure that the consumer does not lose the protection granted by this Directive by virtue of the choice of the law of a non-Member country as the law applicable to the contract if the latter has a close connection with the territory of the Member States. Article 7 1. Member States shall ensure that, in the interests of consumers and of competitors, adequate and effective means exist to prevent the continued use of unfair terms in contracts concluded with consumers by sellers or suppliers. 2. The means referred to in paragraph 1 shall include provisions whereby persons or organizations, having a legitimate interest under national law in protecting consumers, may take action according to the national law concerned before the courts or before competent administrative bodies for a decision as to whether contractual terms drawn up for general use are unfair, so that they can apply appropriate and effective means to prevent the continued use of such terms. 3. With due regard for national laws, the legal remedies referred to in paragraph 2 may be directed separately or jointly against a number of sellers or suppliers from the same economic sector or their associations which use or recommend the use of the same general contractual terms or similar terms. Article 8 Member States may adopt or retain the most stringent provisions compatible with the Treaty in the area covered by this Directive, to ensure a maximum degree of protection for the consumer. Article 9 The Commission shall present a report to the European Parliament and to the Council concerning the application of this Directive five years at the latest after the date in Article 10 (1). Article 10 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 31 December 1994. They shall forthwith inform the Commission thereof. These provisions shall be applicable to all contracts concluded after 31 December 1994. 2. 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. 3. Member States shall communicate the main provisions of national law which they adopt in the field covered by this Directive to the Commission. Article 11 This Directive is addressed to the Member States.

31993L0019

1993

Council Directive 93/19/EEC of 19 April 1993 amending Directive 77/93/EEC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community, and Directive 91/683/EEC Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (4), established, in particular by the amendments made to it by Directive 91/683/EEC (5), the plant health regime applicable in the Community as an area without internal frontiers; Whereas some of its provisions should have been brought into force on 1 January 1993; whereas, according to Article 3 of Directive 91/683/EEC, other provisions should be brought into force six months after the revision of Annexes I to V; Whereas it is essential to provide for appropriate legal security and to ensure that all the provisions are implemented at the earliest possible date, without prejudice to the coming into force of those ensuring on area without internal frontiers, within the meaning of Article 8a of the Treaty; Whereas a single date of implementation should be fixed, Article 1 The dates referred to in Articles 1 (5), 3 (4), 4 (2) (a) and (4), 5 (2) and (4), 6 (4), (5) and (9), 10 (1), (2) (a), (2) (b) and (5) and 12 (6), (7) and (8) of Directive 77/93/EEC are hereby replaced by 1 June 1993. Article 2 The first sentence of Article 3 (1) of Directive 91/683/EEC shall be replaced by the following: 'Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 1 June 1993.' Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 1 June 1993. 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 immediately communicate to the Commission all provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 4 This Directive is addressed to the Member States.

31993L0021

1993

Commission Directive 93/21/EEC of 27 April 1993 adapting to technical progress for the 18th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as last amended by Commission Directive 92/69/EEC (2), and in particular Articles 28 and 29 thereof, Whereas Council Directive 92/32/EEC (3) amends Directive 67/548/EEC as regards the provisions relating to the classification and labelling of dangerous substances; Whereas Annex II to Directive 67/548/EEC contains the symbols and indications of danger; whereas it is necessary to introduce a new symbol for 'dangerous for the environment`; Whereas Annex III to Directive 67/548/EEC contains a list of phrases indicating the nature of the special risks attributed to dangerous substances; whereas it is necessary to introduce new phrases indicating danger to health for substances toxic to reproduction; whereas it is also necessary to introduce new combined risk phrases indicating the danger for the environment; Whereas Annex IV to Directive 67/548/EEC contains a list of the phrases indicating the safety advice concerning dangerous substances; whereas it is necessary to revise certain safety advice phrases related to the dangers for the environment; whereas it is necessary to introduce certain combined phrases relating to the use of dangerous substances and preparations; Whereas Annex VI to Directive 67/548/EEC contains a guide to the classification and labelling of dangerous substances and preparations; whereas it is necessary to amend this guide to include changes resulting from Directive 92/32/EEC; Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for the Elimination of Technical Barriers to Trade in Dangerous Substances and Preparations, Article 1 Directive 67/548/EEC is amended as follows: 1. Annex II is replaced by Annex I to this Directive; 2. Annex III is replaced by Annex II to this Directive; 3. Annex IV is replaced by Annex III to this Directive; 4. in Annex V, method B.2: Acute toxicity (inhalation), Section 1.6.2.4, (Limit test) is replaced by the following: '1.6.2.4. Limit test If an exposure of five male and five female test animals to 20 mg per litre of a gas or 5 mg per litre of an aerosol or a particulate for four hours (or, where this is not possible due to the physical or chemical, including explosive, properties of the test substance, the maximum attainable concentration) produces no compound related mortality within 14 days further testing may not be considered necessary.`; 5. Annex VI, Parts I and II are replaced by Annex IV to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 1994, with the exception of those applicable to mobile gas cylinders containing butane, propane or liquid petroleum gas. Member States shall immediately inform the Commission thereof. 2. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Annex IV, Chapter 8.1 of this Directive in so far as it applies to mobile gas cylinders containing butane, propane or liquid petroleum gas, by 31 October 1997. Member States shall immediately inform the Commission thereof. 3. When Member States adopt the provisions referred to in paragraphs 1 and 2, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

31993L0022

1993

Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field Having regard to the Treaty establishing the European Economic Community, and in particular Article 57 (2) 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 this Directive constitutes an instrument essential to the achievement of the internal market, a course determined by the Single European Act and set out in timetable form in the Commission's White Paper, from the point of view both of the right of establishment and of the freedom to provide financial services, in the field of investment firms; Whereas firms that provide the investment services covered by this Directive must be subject to authorization by their home Member States in order to protect investors and the stability of the financial system; Whereas the approach adopted is to effect only the essential harmonization necessary and sufficient to secure the mutual recognition of authorization and of prudential supervision systems, making possible the grant of a single authorization valid throughout the Community and the application of the principle of home Member State supervision; whereas, by virtue of mutual recognition, investment firms authorized in their home Member States may carry on any or all of the services covered by this Directive for which they have received authorization throughout the Community by establishing branches or under the freedom to provide services; Whereas the principles of mutual recognition and of home Member State supervision require that the Member States' competent authorities should not grant or should withdraw authorization where factors such as the content of programmes of operations, the geographical distribution or the activities actually carried on indicate clearly that an investment firm has opted for the legal system of one Member State for the purpose of evading the stricter standards in force in another Member State within the territory of which it intends to carry on or does carry on the greater part of its activities; whereas, for the purposes of this Directive, an investment firm which is a legal person must be authorized in the Member State in which it has its registered office; whereas an investment firm which is not a legal person must be authorized in the Member State in which it has its head office; whereas, in addition, Member States must require that an investment firm's head office must always be situated in its home Member State and that it actually operates there; Whereas it is necessary, for the protection of investors, to guarantee the internal supervision of every firm, either by means of two-man management or, where that is not required by this Directive, by other mechanisms that ensure an equivalent result; Whereas in order to guarantee fair competition, it must be ensured that investment firms that are not credit institutions have the same freedom to create branches and provide services across frontiers as is provided for by the Second Council Directive (89/646/EEC) of 15 December 1989 on the coordination of laws, regulations and administrative provisions relating to the taking up and pursuit of the business of credit institutions (4); Whereas an investment firm should not be able to invoke this Directive in order to carry out spot or forward exchange transactions other than as services connected with the provision or investment services; whereas, therefore, the use of a branch solely for such foreign-exchange transactions would constitute misuse of the machinery of this Directive; Whereas an investment firm authorized in its home Member State may carry on business throughout the Community by whatever means it deems appropriate; whereas, to that end it may, if it deems it necessary, retain tied agents to receive and transmit orders for its account and under its full and unconditional responsibility; whereas, in these circumstances, such agents' business must be regarded as that of the firm; whereas, moreover, this Directive does not prevent a home Member State from making the status of such agents subject to special requirements; whereas should the investment firm carry on cross-border business, the host Member State must treat those agents as being the firm itself; whereas, moreover, the door-to-door selling of transferable securities should not be covered by this Directive and the regulation thereof should remain a matter for national provisions; Whereas 'transferable securities' means those classes of securities which are normally dealt in on the capital market, such as government securities, shares in companies, negotiable securities giving the right to acquire shares by subscription or exchange, depositary receipts, bonds issued as part of a series, index warrants and securities giving the right to acquire such bonds by subscription; Whereas 'money-market instruments' means those classes of instruments which are normally dealt in on the money market such as treasury bills, certificates of deposit and commercial paper; Whereas the very wide definitions of transferable securities and money-market instruments included in this Directive are valid only for this Directive and consequently in no way affect the various definitions of financial instruments used in national legislation for other purposes such as taxation; whereas, furthermore, the definition of transferable securities covers negotiable instruments only; whereas, consequently, shares and other securities equivalent to shares issued by bodies such as building societies and industrial and provident societies, ownership of which cannot in practice be transferred except by the issuing body's buying them back, are not covered by this definition; Whereas 'instrument equivalent to a financial-futures contract' means a contract which is settled by a payment in cash calculated by reference to fluctuations in interest or exchange rates, the value of any instrument listed in Section B of the Annex or an index of any such instruments; Whereas, for the purposes of this Directive, the business of the reception and transmission of orders also includes bringing together two or more investors thereby bringing about a transaction between those investors; Whereas no provision in this Directive affects the Community provisions or, failing such, the national provisions regulating public offers of the instruments covered by this Directive; whereas the same applies to the marketing and distribution of such instruments; Whereas Member States retain full responsibility for implementing their own monetary-policy measures, without prejudice to the measures necessary to strengthen the European Monetary System; Whereas it is necessary to exclude insurance undertakings the activities of which are subject to appropriate monitoring by the competent prudential-supervision authorities and which are coordinated at Community level and undertakings carrying out reinsurance and retrocession activities; Whereas undertakings which do not provide services for third parties but the business of which consists in providing investment services solely for their parent undertakings, for their subsidiaries, or for other subsidiaries of their parent undertakings should not be covered by this Directive; Whereas the purpose of this Directive is to cover undertakings the normal business of which is to provide third parties with investment services on a professional basis; whereas its scope should not therefore cover any person with a different professional activity (e.g. a barrister or solicitor) who provides investment services only on an incidental basis in the course of that other professional activity, provided that that activity is regulated and the relevant rules do not prohibit the provision, on an incidental basis, of investment services; whereas it is also necessary for the same reason to exclude from the scope of this Directive persons who provide investment services only for producers or users of commodities to the extent necessary for transactions in such products where such transactions constitute their main business; Whereas firms which provide investment services consisting exclusively in the administration of employee-participation schemes and which therefore do not provide investment services for third parties should not be covered by this Directive; Whereas it is necessary to exclude from the scope of this Directive central banks and other bodies performing similar functions as well as public bodies charged with or intervening in the management of the public debt, which concept covers the investment thereof; whereas, in particular, this exclusion does not cover bodies that are partly or wholly State-owned the role of which is commercial or linked to the acquisition of holdings; Whereas it is necessary to exclude from the scope of this Directive any firms or persons whose business consists only of receiving and transmitting orders to certain counterparties and who do not hold funds or securities belonging to their clients; whereas, therefore, they will not enjoy the right of establishment and freedom to provide services under the conditions laid down in this Directive, being subject, when they wish to operate in another Member State, to the relevant provisions adopted by that State; Whereas it is necessary to exclude from the scope of this Directive collective investment undertakings whether or not coordinated at Community level, and the depositaries or managers of such undertakings, since they are subject to specific rules directly adapted to their activities; Whereas, where associations created by a Member State's pension funds to permit the management of their assets confine themselves to such management and do not provide investment services for third parties, and where the pension funds are themselves subject to the control of the authorities charged with monitoring insurance undertakings, it does not appear to be necessary to subject such associations to the conditions for taking up business and for operation imposed by this Directive; Whereas this Directive should not apply to 'agenti di cambio' as defined by Italian law since they belong to a category the authorization of which is not to be renewed, their activities are confined to the national territory and they do not give rise to a risk of the distortion of competition; Whereas the rights conferred on investment firms by this Directive are without prejudice to the right of Member States, central banks and other national bodies performing similar functions to choose their counterparties on the basis of objective, non-discriminatory criteria; Whereas responsibility for supervising the financial soundness of an investment firm will rest with the competent authorities of its home Member State pursuant to Council Directive 93/6/EEC of 15 March 1993 on the capital adequacy of investment firms and credit institutions (5), which coordinates the rules applicable to market risk; Whereas a home Member State may, as a general rule, establish rules stricter than those laid down in this Directive, in particular as regards authorization conditions, prudential requirements and the rules of reporting and transparency; Whereas the carrying on of activities not covered by this Directive is governed by the general provisions of the Treaty on the right of establishment and the freedom to provide services; Whereas in order to protect investors an investor's ownership and other similar rights in respect of securities and his rights in respect of funds entrusted to a firm should in particular be protected by being kept distinct from those of the firm; whereas this principle does not, however, prevent a firm from doing business in its name but on behalf of the investor, where that is required by the very nature of the transaction and the investor is in agreement, for example stock lending; Whereas the procedures for the authorization of branches of investment firms authorized in third countries will continue to apply to such firms; whereas those branches will not enjoy the freedom to provide services under the second paragraph of Article 59 of the Treaty or the right of establishment in Member States other than those in which they are established; whereas, however, requests for the authorization of subsidiaries or of the acquisition of holdings by undertakings governed by the laws of third countries are subject to a procedure intended to ensure that Community investment firms receive reciprocal treatment in the third countries in question; Whereas the authorizations granted to investment firms by the competent national authorities pursuant to this Directive will have Community-wide, and no longer merely nationwide application, and existing reciprocity clauses will henceforth have no effect; whereas a flexible procedure is therefore needed to make it possible to assess reciprocity on a Community basis; whereas the aim of this procedure is not to close the Community's financial markets but rather, as the Community intends to keep its financial markets open to the rest of the world, to improve the liberalization of the global financial markets in third countries; whereas, to that end, this Directive provides for procedures for negotiating with third countries and, as a last resort, for the possibility of taking measures involving the suspension of new applications for authorization and the restriction of new authorizations; Whereas one of the objectives of this Directive is to protect investors; whereas it is therefore appropriate to take account of the different requirements for protection of various categories of investors and of their levels of professional expertise; Whereas the Member States must ensure that there are no obstacles to prevent activities that receive mutual recognition from being carried on in the same manner as in the home Member State, as long as they do not conflict with laws and regulations protecting the general good in force in the host Member State; Whereas a Member State may not limit the right of investors habitually resident or established in that Member State to avail themselves of any investment service provided by an investment firm covered by this Directive situated outside that Member State and acting outwith that Member State; Whereas in certain Member States clearing and settlement functions may be performed by bodies separate from the markets on which transactions are effected; whereas, accordingly, any reference in this Directive to access to and membership of regulated markets should be read as including references to access to and membership of bodies performing clearing and settlement functions for regulated markets; Whereas each Member State must ensure that within its territory, treatment of all investment firms authorized in any Member State and likewise all financial instruments listed on the Member States' regulated markets is non-discriminatory; whereas investment firms must all have the same opportunities of joining or having access to regulated markets; whereas, regardless of the manner in which transactions are at present organized in the Member States, it is therefore important, subject to the conditions imposed by this Directive, to abolish the technical and legal restrictions on access to the regulated markets within the framework of this Directive; Whereas some Member States authorize credit institutions to become members of their regulated markets only indirectly, by setting up specialized subsidiaries; whereas the opportunity which this Directive gives credit institutions of becoming members of regulated markets directly without having to set up specialized subsidiaries constitutes a significant reform for those Member States and all its consequences should be reassessed in the light of the development of the financial markets; whereas, in view of those factors, the report which the Commission will submit to the Council on this matter no later than 31 December 1998 will have to take account of all the factors necessary for the Council to be able to reassess the consequences for those Member States, and in particular the danger of conflicts of interest and the level of protection afforded to investors; Whereas it is of the greatest importance that the harmonization of compensation systems be brought into effect on the same date as this Directive; whereas, moreover, until the date on which a Directive harmonizing compensation systems is brought into effect, host Member States will be able to impose application of their compensation systems on investment firms including credit institutions authorized by other Member States, where the home Member States have no compensation systems or where their systems do not offer equivalent levels of protection; Whereas the structure of regulated markets must continue to be governed by national law, without thereby forming an obstacle to the liberalization of access to the regulated markets of host Member States for investment firms authorized to provide the services concerned in their home Member States; whereas, pursuant to that principle, the law of the Federal Republic of Germany and the law of the Netherlands govern the activities Kursmakler and hoekmannen respectively so as to ensure that they do not exercise their functions in parallel with other functions; whereas it should be noted that Kursmakler and hoekmannen may not provide services in other Member States; whereas no one, whatever his home Member State, may claim to act as a Kursmakler or a hoekman without being subject to the same rules on incompatibility as result from the status of Kursmakler or hoekman; Whereas it should be noted that this Directive cannot affect the measures taken pursuant to Council Directive 79/279/EEC of 5 March 1979 coordinating the conditions for the admission of securities to official stock-exchange listing (6); Whereas the stability and sound operation of the financial system and the protection of investors presuppose that a host Member State has the right and responsibility both to prevent and to penalize any action within its territory by investment firms contrary to the rules of conduct and other legal or regulatory provisions it has adopted in the interest of the general good and to take action in emergencies; whereas, moreover, the competent authorities of the host Member State must, in discharging their responsibilities, be able to count on the closest cooperation with the competent authorities of the home Member State, particularly as regards business carried on under the freedom to provide services; whereas the competent authorities of the home Member State are entitled to be informed by the competent authorities of the host Member State of any measures involving penalties on an investment firm or restrictions on its activities which the latter have taken vis-à-vis the investment firms which the former have authorized so as to be able to perform their function of prudential supervision efficiently; whereas to that end cooperation between the competent authorities of home and host Member States must be ensured; Whereas, with the two-fold aim of protecting investors and ensuring the smooth operation of the markets in transferable securities, it is necessary to ensure that transparency of transactions is achieved and that the rules laid down for that purpose in this Directive for regulated markets apply both to investment firms and to credit institutions when they operate on the market; Whereas examination of the problems arising in the areas covered by the Council Directives on investment services and securities, as regards both the application of existing measures and the possibility of closer coordination in the future, requires cooperation between national authorities and the Commission within a committee; whereas the establishment of such a committee does not rule out other forms of cooperation between supervisory authorities in this field; Whereas technical amendments to the detailed rules laid down in this Directive may from time to time be necessary to take account of new developments in the investment-services sector; whereas the Commission will make such amendments as are necessary, after referring the matter to the committee to be set up in the securities-markets field, TITLE I Definitions and scope Article 1 For the purposes of this Directive: 1. investment service shall mean any of the services listed in Section A of the Annex relating to any of the instruments listed in Section B of the Annex that are provided for a third party; 2. investment firm shall mean any legal person the regular occupation or business of which is the provision of investment services for third parties on a professional basis. For the purposes of this Directive, Member States may include as investment firms undertakings which are not legal persons if: - their legal status ensures a level of protection for third parties' interests equivalent to that afforded by legal persons, and - they are subject to equivalent prudential supervision appropriate to their legal form. However, where such natural persons provide services involving the holding of third parties' funds or transferable securities, they may be considered as investment firms for the purposes of this Directive only if, without prejudice to the other requirements imposed in this Directive and in Directive 93/6/EEC, they comply with the following conditions: - the ownership rights of third parties in instruments and funds belonging to them must be safeguarded, especially in the event of the insolvency of a firm or of its proprietors, seizure, set-off or any other action by creditors of the firm or of its proprietors, - an investment firm must be subject to rules designed to monitor the firm's solvency and that of its proprietors, - an investment firm's annual accounts must be audited by one or more persons empowered, under national law, to audit accounts, - where a firm has only one proprietor, he must make provision for the protection of investors in the event of the firm's cessation of business following his death, his incapacity or any other such event. No later than 31 December 1997 the Commission shall report on the application of the second and third subparagraphs of this point and, if appropriate, propose their amendment or deletion. Where a person provides one of the services referred to in Section A (1) (a) of the Annex and where that activity is carried on solely for the account of and under the full and unconditional responsibility of an investment firm, that activity shall be regarded as the activity not of that person but of the investment firm itself; 3. credit institution shall mean a credit institution as defined in the first indent of Article 1 of Directive 77/780/EEC (7) with the exception of the institutions referred to in Article 2 (2) thereof; 4. transferable securities shall mean: - shares in companies and other securities equivalent to shares in companies, - bonds and other forms of securitized debt which are negotiable on the capital market and - any other securities normally dealt in giving the right to acquire any such transferable securities by subscription or exchange or giving rise to a cash settlement excluding instruments of payment; 5. money-market instruments shall mean those classes of instruments which are normally dealt in on the money market; 6. home Member State shall mean: (a) where the investment firm is a natural person, the Member State in which his head office is situated; (b) where the investment firm is a legal person, the Member State in which its registered office is situated or, if under its national law it has no registered office, the Member State in which its head office is situated; (c) in the case of a market, the Member State in which the registered office of the body which provides trading facilities is situated or, if under its national law it has no registered office, the Member State in which that body's head office is situated; 7. host Member State shall mean the Member State in which an investment firm has a branch or provides services; 8. branch shall mean a place of business which is a part of an investment firm, which has no legal personality and which provides investment services for which the investment firm has been autorized; all the places of business set up in the same Member State by an investment firm with headquarters in another Member State shall be regarded as a single branch; 9. competent authorities shall mean the authorities which each Member State designates under Article 22; 10. qualifying holding shall mean any direct or indirect holding in an investment firm which represents 10 % or more of the capital or of the voting rights or which makes it possible to exercise a significant influence over the management of the investment firm in which that holding subsists. For the purposes of this definition, in the context of Articles 4 and 9 and of the other levels of holding referred to in Article 9, the voting rights referred to in Article 7 of Directive 88/627/EEC (8) shall be taken into account; 11. parent undertaking shall mean a parent undertaking as defined in Articles 1 and 2 of Directive 83/349/EEC (9); 12. subsidiary shall mean a subsidiary undertaking as defined in Articles 1 and 2 of Directive 83/349/EEC; any subsidiary of a subsidiary undertaking shall also be regarded as a subsidiary of the parent undertaking which is the ultimate parent of those undertakings; 13. regulated market shall mean a market for the instruments listed in Section B of the Annex which: - appears on the list provided for in Article 16 drawn up by the Member State which is the home Member State as defined in Article 1 (6) (c), - functions regularly, - is characterized by the fact that regulations issued or approved by the competent authorities define the conditions for the operation of the market, the conditions for access to the market and, where Directive 79/279/EEC is applicable, the conditions governing admission to listing imposed in that Directive and, where that Directive is not applicable, the conditions that must be satisfied by a financial instrument before it can effectively be dealt in on the market, - requires compliance with all the reporting and transparency requirements laid down pursuant to Articles 20 and 21; 14. control shall mean control as defined in Article 1 of Directive 83/349/EEC. Article 2 1. This Directive shall apply to all investment firms. Only paragraph 4 of this Article and Articles 8 (2), 10, 11, 12, first paragraph, 14 (3) and (4), 15, 19 and 20, however, shall apply to credit institutions the authorization of which, under Directives 77/780/EEC and 89/646/EEC, covers one or more of the investment services listed in Section A of the Annex to this Directive. 2. This Directive shall not apply to: (a) insurance undertakings as defined in Article 1 of Directive 73/239/EEC (10) or Article 1 of Directive 79/267/EEC (11) or undertakings carrying on the reinsurance and retrocession activities referred to in Directive 64/225/EEC (12); (b) firms which provide investment services exclusively for their parent undertakings, for their subsidiaries or for other subsidiaries of their parent undertakings; (c) persons providing an investment service where that service is provided in an incidental manner in the course of a professional activity and that activity is regulated by legal or regulatory provisions or a code of ethics governing the profession which do not exclude the provision of that service; (d) firms that provide investment services consisting exclusively in the administration of employee-participation schemes; (e) firms that provide investment services that consist in providing both the services referred to in (b) and those referred to in (d); (f) the central banks of Member States and other national bodies performing similar functions and other public bodies charged with or intervening in the management of the public debt; (g) firms - which may not hold clients' funds or securities and which for that reason may not at any time place themselves in debit with their clients, and - which may not provide any investment service except the reception and transmission of orders in transferable securities and units in collective investment undertakings, and - which in the course of providing that service may transmit orders only to (i) investment firms authorized in accordance with this Directive; (ii) credit institutions authorized in accordance with Directives 77/780/EEC and 89/646/ EEC; (iii) branches of investment firms or of credit institutions which are authorized in a third country and which are subject to and comply with prudential rules considered by the competent authorities as at least as stringent as those laid down in this Directive, in Directive 89/646/EEC or in Directive 93/6/EEC; (iv) collective investment undertakings authorized under the law of a Member State to market units to the public and to the managers of such undertakings; (v) investment companies with fixed capital, as defined in Article 15 (4) of Directive 77/91/EEC (13), the securities of which are listed or dealt in on a regulated market in a Member State; - the activities of which are governed at national level by rules or by a code of ethics; (h) collective investment undertakings whether coordinated at Community level or not and the depositaries and managers of such undertakings; (i) persons whose main business is trading in commodities amongst themselves or with producers or professional users of such products and who provide investment services only for such producers and professional users to the extent necessary for their main business; (j) firms that provide investment services consisting exclusively in dealing for their own account on financial-futures or options markets or which deal for the accounts of other members of those markets or make prices for them and which are guaranteed by clearing members of the same markets. Responsibility for ensuring the performance of contracts entered into by such firms must be assumed by clearing members of the same markets; (k) associations set up by Danish pension funds with the sole aim of managing the assets of pension funds that are members of those associations; (l) 'agenti di cambio' whose activities and functions are governed by Italian Royal Decree No 222 of 7 March 1925 and subsequent provisions amending it, and who are authorized to carry on their activities under Article 19 of Italian Law No 1 of 2 January 1991. 3. No later than 31 December 1998 and at regular intervals thereafter the Commission shall report on the application of paragraph 2 in conjunction with Section A of the Annex and shall, where appropriate, propose amendments to the definition of the exclusions and the services covered in the light of the operation of this Directive. 4. The rights conferred by this Directive shall not extend to the provision of services as counterparty to the State, the central bank or other Member State national bodies performing similar functions in the pursuit of the monetary, exchange-rate, public-debt and reserves management policies of the Member State concerned. TITLE II Conditions for taking up business Article 3 1. Each Member State shall make access to the business of investment firms subject to authorization for investment firms of which it is the home Member State. Such authorization shall be granted by the home Member State's competent authorities designated in accordance with Article 22. The authorization shall specify the investment services referred to in Section A of the Annex which the undertaking is authorized to provide. The authorization may also cover one or more of the non-core services referred to in Section C of the Annex. Authorization within the meaning of this Directive may in no case be granted for services covered only by Section C of the Annex. 2. Each Member State shall require that: - any investment firm which is a legal person and which, under its national law, has a registered office shall have its head office in the same Member State as its registered office, - any other investment firm shall have its head office in the Member State which issued its authorization and in which it actually carries on its business. 3. Without prejudice to other conditions of general application laid down by national law, the competent authorities shall not grant authorization unless: - an investment firm has sufficient initial capital in accordance with the rules laid down in Directive 93/6/EEC having regard to the nature of the investment service in question, - the persons who effectively direct the business of an investment firm are of sufficiently good repute and are sufficiently experienced. The direction of a firm's business must be decided by at least two persons meeting the above conditions. Where an appropriate arrangement ensures that the same result will be achieved, however, particularly in the cases provided for in the last indent of the third subparagraph of Article 1 (2), the competent authorities may grant authorization to investment firms which are natural persons or, taking account of the nature and volume of their activities, to investment firms which are legal persons where such firms are managed by single natural persons in accordance with their articles of association and national laws. 4. Member States shall also require that every application for authorization be accompanied by a programme of operations setting out inter alia the types of business envisaged and the organizational structure of the investment firm concerned. 5. An applicant shall be informed within six months of the submission of a complete application whether or not authorization has been granted. Reasons shall be given whenever an authorization is refused. 6. An investment firm may commence business as soon as authorization has been granted. 7. The competent authorities may withdraw the authorization issued to an investment firm subject to this Directive only where that investment firm: (a) does not make use of the authorization within 12 months, expressly renounces the authorization or ceased to provide investment services more than six months previously unless the Member State concerned has provided for authorization to lapse in such cases; (b) has obtained the authorization by making false statements or by any other irregular means; (c) no longer fulfils the conditions under which authorization was granted; (d) no longer complies with Directive 93/6/EEC; (e) has seriously and systematically infringed the provisions adopted pursuant to Articles 10 or 11; or (f) falls within any of the cases where national law provides for withdrawal. Article 4 The competent authorities shall not grant authorization to take up the business of investment firms until they have been informed of the identities of the shareholders or members, whether direct or indirect, natural or legal persons, that have qualifying holdings and of the amounts of those holdings. The competent authorities shall refuse authorization if, taking into account the need to ensure the sound and prudent management of an investment firm, they are not satisfied as to the suitability of the aforementioned shareholders or members. Article 5 In the case of branches of investment firms that have registered offices outwith the Community and are commencing or carrying on business, the Member States shall not apply provisions that result in treatment more favourable than that accorded to branches of investment firms that have registered offices in Member States. Article 6 The competent authorities of the other Member State involved shall be consulted beforehand on the authorization of any investment firm which is: - a subsidiary of an investment firm or credit institution authorized in another Member State, - a subsidiary of the parent undertaking of an investment firm or credit institution authorized in another Member State, or - controlled by the same natural or legal persons as control an investment firm or credit institution authorized in another Member State. TITLE III Relations with third countries Article 7 1. The competent authorities of the Member States shall inform the Commission: (a) of the authorization of any firm which is the direct or indirect subsidiary of a parent undertaking governed by the law of a third country; (b) whenever such a parent undertaking acquires a holding in a Community investment firm such that the latter would become its subsidiary. In both cases the Commission shall inform the Council until such time as a committee on transferable securities is set up by the Council acting on a proposal from the Commission. When authorization is granted to any firm which is the direct or indirect subsidiary of a parent undertaking governed by the law of a third country, the competent authorities shall specify the structure of the group in the notification which they address to the Commission. 2. The Member States shall inform the Commission of any general difficulties which their investment firms encounter in establishing themselves or providing investment services in any third country. 3. Initially no later than six months before this Directive is brought into effect and thereafter periodically the Commission shall draw up a report examining the treatment accorded to Community investment firms in third countries, in the terms referred to in paragraphs 4 and 5, as regards establishment, the carrying on of investment services activities and the acquisition of holdings in third-country investment firms. The Commission shall submit those reports to the Council together with any appropriate proposals. 4. Whenever it appears to the Commission, either on the basis of the reports provided for in paragraph 3 or on the basis of other information, that a third country does not grant Community investment firms effective market access comparable to that granted by the Community to investment firms from that third country, the Commission may submit proposals to the Council for an appropriate mandate for negotiation with a view to obtaining comparable competitive opportunities for Community investment firms. The Council shall act by a qualified majority. 5. Whenever it appears to the Commission, either on the basis of the reports referred to in paragraph 3 or on the basis of other information, that Community investment firms in a third country are not granted national treatment affording the same competitive opportunities as are available to domestic investment firms and that the conditions of effective market access are not fulfilled, the Commission may initiate negotiations in order to remedy the situation. In the circumstances described in the first subparagraph it may also be decided, at any time and in addition to the initiation of negotiations, in accordance with the procedure to be laid down in the Directive by which the Council will set up the committee referred to in paragraph 1, that the competent authorities of the Member States must limit or suspend their decisions regarding requests pending or future requests for authorization and the acquisition of holdings by direct or indirect parent undertakings governed by the law of the third country in question. The duration of such measures may not exceed three months. Before the end of that three-month period and in the light of the results of the negotiations the Council may, acting on a proposal from the Commission, decide by a qualified majority whether the measures shall be continued. Such limitations or suspensions may not be applied to the setting up of subsidiaries by investment firms duly authorized in the Community or by their subsidiaries, or to the acquisition of holdings in Community investment firms by such firms or subsidiaries. 6. Whenever it appears to the Commission that one of the situations described in paragraphs 4 and 5 obtains, the Member States shall inform it at its request: (a) of any application for the authorization of any firm which is the direct or indirect subsidiary of a parent undertaking governed by the law of the third country in question; (b) whenever they are informed in accordance with Article 10 that such a parent undertaking proposes to acquire a holding in a Community investment firm such that the latter would become its subsidiary. This obligation to provide information shall lapse whenever agreement is reached with the third country referred to in paragraph 4 or 5 or when the measures referred to in the second and third subparagraphs of paragraph 5 cease to apply. 7. Measures taken under this Article shall comply with the Community's obligations under any international agreements, bilateral or multilateral, governing the taking up or pursuit of the business of investment firms. TITLE IV Operating conditions Article 8 1. The competent authorities of the home Member States shall require that an investment firm which they have authorized comply at all times with the conditions imposed in Article 3 (3). 2. The competent authorities of the home Member State shall require that an investment firm which they have authorized comply with the rules laid down in Directive 93/6/EEC. 3. The prudential supervision of an investment firm shall be the responsibility of the competent authorities of the home Member State whether the investment firm establishes a branch or provides services in another Member State or not, without prejudice to those provisions of this Directive which give responsibility to the authorities of the host Member State. Article 9 1. Member States shall require any person who proposes to acquire, directly or indirectly, a qualifying holding in an investment firm first to inform the competent authorities, telling them of the size of his intended holding. Such a person shall likewise inform the competent authorities if he proposes to increase his qualifying holding so that the proportion of the voting rights or of the capital that he holds would reach or exceed 20, 33, or 50 % or so that the investment firm would become his subsidiary. Without prejudice to paragraph 2, the competent authorities shall have up to three months from the date of the notification provided for in the first subparagraph to oppose such a plan if, in view of the need to ensure sound and prudent management of the investment firm, they are not satisfied as to the suitability of the person referred to in the first subparagraph. If they do not oppose the plan, they may fix a deadline for its implementation. 2. If the acquirer of the holding referred to in paragraph 1 is an investment firm authorized in another Member State or the parent undertaking of an investment firm authorized in another Member State or a person controlling an investment firm authorized in another Member State and if, as a result of that acquisition, the firm in which the acquirer proposes to acquire a holding would become the acquirer's subsidiary or come under his control, the assessment of the acquisition must be the subject of the prior consultation provided for in Article 6. 3. Member States shall require any person who proposes to dispose, directly or indirectly, of a qualifying holding in an investment firm first to inform the competent authorities, telling them of the size of his holding. Such a person shall likewise inform the competent authorities if he proposes to reduce his qualifying holding so that the proportion of the voting rights or of the capital held by him would fall below 20, 33 or 50 % or so that the investment firm would cease to be his subsidiary. 4. On becoming aware of them, investment firms shall inform the competent authorities of any acquisitions or disposals of holdings in their capital that cause holdings to exceed or fall below any of the thresholds referred to in paragraphs 1 and 3. At least once a year they shall also inform the competent authorities of the names of shareholders and members possessing qualifying holdings and the sizes of such holdings as shown, for example, by the information received at annual general meetings of shareholders and members or as a result of compliance with the regulations applicable to companies listed on stock exchanges. 5. Member States shall require that, where the influence exercised by the persons referred to in paragraph 1 is likely to be prejudicial to the sound and prudent management of an investment firm, the competent authorities take appropriate measures to put an end to that situation. Such measures may consist, for example, in injunctions, sanctions against directors and those responsible for management or suspension of the exercise of the voting rights attaching to the shares held by the shareholders or members in question. Similar measures shall apply to persons failing to comply with the obligation to provide prior information imposed in paragraph 1. If a holding is acquired despite the opposition of the competent authorities, the Member States shall, regardless of any other sanctions to be adopted, provide either for exercise of the corresponding voting rights to be suspended, for the nullity of the votes cast or for the possibility of their annulment. Article 10 Each home Member State shall draw up prudential rules which investment firms shall observe at all times. In particular, such rules shall require that each investment firm: - have sound administrative and accounting procedures, control and safeguard arrangements for electronic data processing, and adequate internal control mechanisms including, in particular, rules for personal transactions by its employees, - make adequate arrangements for instruments belonging to investors with a view to safeguarding the latter's ownership rights, especially in the event of the investment firm's instruments for its own account except with the investors' express consent, - make adequate arrangements for funds belonging to investors with a view to safeguarding the latter's rights and, except in the case of credit institutions, preventing the investment firm's using investors' funds for its own account, - arrange for records to be kept of transactions executed which shall at least be sufficient to enable the home Member State's authorities to monitor compliance with the prudential rules which they are responsible for applying; such records shall be retained for periods to be laid down by the competent authorities, - be structured and organized in such a way as to minimize the risk of clients' interests being prejudiced by conflicts of interest between the firm and its clients or between one of its clients and another. Nevertheless, where a branch is set up the organizational arrangements may not conflict with the rules of conduct laid down by the host Member State to cover conflicts of interest. Article 11 1. Member States shall draw up rules of conduct which investment firms shall observe at all times. Such rules must implement at least the principles set out in the following indents and must be applied in such a way as to take account of the professional nature of the person for whom the service is provided. The Member States shall also apply these rules where appropriate to the non-core services listed in Section C of the Annex. These principles shall ensure that an investment firm: - acts honestly and fairly in conducting its business activities in the best interests of its clients and the integrity of the market, - acts with due skill, care and diligence, in the best interests of its clients and the integrity of the market, - has and employs effectively the resources and procedures that are necessary for the proper performance of its business activities, - seeks from its clients information regarding their financial situations, investment experience and objectives as regards the services requested, - makes adequate disclosure of relevant material information in its dealings with its clients, - tries to avoid conflicts of interests and, when they cannot be avoided, ensures that its clients are fairly treated, and - complies with all regulatory requirements applicable to the conduct of its business activities so as to promote the best interests of its clients and the integrity of the market. 2. Without prejudice to any decisions to be taken in the context of the harmonization of the rules of conduct, their implementation and the supervision of compliance with them shall remain the responsibility of the Member State in which a service is provided. 3. Where an investment firm executes an order, for the purposes of applying the rules referred to in paragraph 1 the professional nature of the investor shall be assessed with respect to the investor from whom the order originates, regardless of whether the order was placed directly by the investor himself or indirectly through an investment firm providing the service referred to in Section A (1) (a) of the Annex. Article 12 Before doing business with them, a firm shall inform investors which compensation fund or equivalent protection will apply in respect of the transactions envisaged, what cover is offered by whichever system applies, or if there is no fund or compensation. The Council notes the Commission's statement to the effect that it will submit proposals on the harmonization of compensation systems covering transactions by investment firms by 31 July 1993 at the latest. The Council will act on those proposals within the shortest possible time with the aim of bringing the systems proposed into effect on the same date as this Directive. Article 13 This Directive shall not prevent investment firms authorized in other Member States from advertising their services through all available means of communication in their host Member States, subject to any rules governing the form and the content of such advertising adopted in the interest of the general good. TITLE V The right of establishment and the freedom to provide services Article 14 1. Member States shall ensure that investment services and the other services listed in Section C of the Annex may be provided within their territories in accordance with Articles 17, 18 and 19 either by the establishment of a branch or under the freedom to provide services by any investment firm authorized and supervised by the competent authorities of another Member State in accordance with this Directive, provided that such services are covered by the authorization. This Directive shall not affect the powers of host Member States in respect of the units of collective investment undertakings to which Directive 85/611/EEC (14) does not apply. 2. Member States may not make the establishment of a branch or the provision of services referred to in paragraph 1 subject to any authorization requirement, to any requirement to provide endowment capital or to any other measure having equivalent effect. 3. A Member State may require that transactions relating to the services referred to in paragraph 1 must, where they satisfy all the following criteria, be carried out on a regulated market: - the investor must be habitually resident or established in that Member State, - the investment firm must carry out such transactions through a main establishment, through a branch situated in that Member State or under the freedom to provide services in that Member State, - the transaction must involve a instrument dealt in on a regulated market in that Member State. 4. Where a Member State applies paragraph 3 it shall give investors habitually resident or established in that Member State the right not to comply with the obligation imposed in paragraph 3 and have the transactions referred to in paragraph 3 carried out away from a regulated market. Member States may make the exercise of this right subject to express authorization, taking into account investors' differing needs for protection and in particular the ability of professional and institutional investors to act in their own best interests. It must in any case be possible for such authorization to be given in conditions that do not jeopardize the prompt execution of investors' orders. 5. The Commission shall report on the operation of paragraphs 3 and 4 not later than 31 December 1998 and shall, if appropriate, propose amendments thereto. Article 15 1. Without prejudice to the exercise of the right of establishment or the freedom to provide services referred to in Article 14, host Member States shall ensure that investment firms which are authorized by the competent authorities of their home Member States to provide the services referred to in Section A (1) (b) and (2) of the Annex can, either directly or indirectly, become members of or have access to the regulated markets in their host Member States where similar services are provided and also become members of or have access to the clearing and settlement systems which are provided for the members of such regulated markets there. Member States shall abolish any national rules or laws or rules of regulated markets which limit the number of persons allowed access thereto. If, by virtue of its legal structure or its technical capacity, access to a regulated market is limited, the Member State concerned shall ensure that its structure and capacity are regularly adjusted. 2. Membership of or access to a regulated market shall be conditional on investment firms' complying with capital adequacy requirements and home Member States' supervising such compliance in accordance with Directive 93/6/EEC. Host Member States shall be entitled to impose additional capital requirements only in respect of matters not covered by that Directive. Access to a regulated market, admission to membership thereof and continued access or membership shall be subject to compliance with the rules of the regulated market in relation to the constitution and administration of the regulated market and to compliance with the rules relating to transactions on the market, with the professional standards imposed on staff operating on and in conjunction with the market, and with the rules and procedures for clearing and settlement. The detailed arrangements for implementing these rules and procedures may be adapted as appropriate, inter alia to ensure fulfilment of the ensuing obligations, provided, however, that Article 28 is complied with. 3. In order to meet the obligation imposed in paragraph 1, host Member States shall offer the investment firms referred to in that paragraph the choice of becoming members of or of having access to their regulated markets either: - directly, by setting up branches in the host Member States, or - indirectly, by setting up subsidiaries in the host Member States or by acquiring firms in the host Member States that are already members of their regulated markets or already have access thereto. However, those Member States which, when this Directive is adopted, apply laws which do not permit credit institutions to become members of or have access to regulated markets unless they have specialized subsidiaries may continue until 31 December 1996 to apply the same obligation in a non-discriminatory way to credit institutions from other Member States for purposes of access to those regulated markets. The Kingdom of Spain, the Hellenic Republic and the Portuguese Republic may extend that period until 31 December 1999. One year before that date the Commission shall draw up a report, taking into account the experience acquired in applying this Article and shall if appropriate, submit a proposal. The Council may, acting by qualified majority on the basis of that proposal, decide to review those arrangements. 4. Subject to paragraphs 1, 2 and 3, where the regulated market of the host Member State operates without any requirement for a physical presence the investment firms referred to in paragraph 1 may become members of or have access to it on the same basis without having to be established in the host Member State. In order to enable their investment firms to become members of or have access to host Member States' regulated markets in accordance with this paragraph home Member States shall allow those host Member States' regulated markets to provide appropriate facilities within the home Member States' territories. 5. This Article shall not affect the Member States' right to authorize or prohibit the creation of new markets within their territories. 6. This Article shall have no effect: - in the Federal Republic of Germany, on the regulation of the activities of Kursmakler, or - in the Netherlands, on the regulation of the activities of hoekmannen. Article 16 For the purposes of mutual recognition and the application of this Directive, it shall be for each Member State to draw up a list of the regulated markets for which it is the home Member State and which comply with its regulations, and to forward that list for information, together with the relevant rules of procedures and operation of those regulated markets, to the other Member States and the Commission. A similar communication shall be effected in respect of each change to the aforementioned list or rules. The Commission shall publish the lists of regulated markets and updates thereto in the Official Journal of the European Communities at least once a year. No later than 31 December 1996 the Commission shall report on the information thus received and, where appropriate, propose amendments to the definition of regulated market for the purposes of this Directive. Article 17 1. In addition to meeting the conditions imposed in Article 3, any investment firm wishing to establish a branch within the territory of another Member State shall notify the competent authorities of its home Member State. 2. Member States shall require every investment firm wishing to establish a branch within the territory of another Member State to provide the following information when effecting the notification provided for in paragraph 1: (a) the Member State within the territory of which it plans to establish a branch; (b) a programme of operations setting out inter alia the types of business envisaged and the organizational structure of the branch; (c) the address in the host Member State from which documents may be obtained; (d) the names of those responsible for the management of the branch. 3. Unless the competent authorities of the home Member State have reason to doubt the adequacy of the administrative structure or the financial situation of an investment firm, taking into account the activities envisaged, they shall, within three months of receiving all the information referred to in paragraph 2, communicate that information to the competent authorities of the host Member State and shall inform the investment firm concerned accordingly. They shall also communicate details of any compensation scheme intended to protect the branch's investors. Where the competent authorities of the home Member State refuse to communicate the information referred to in paragraph 2 to the competent authorities of the host Member State, they shall give reasons for their refusal to the investment firm concerned within three months of receiving all the information. That refusal or failure to reply shall be subject to the right to apply to the courts in the home Member States. 4. Before the branch of an investment firm commences business the competent authorities of the host Member State shall, within two months of receiving the information referred to in paragraph 3, prepare for the supervision of the investment firm in accordance with Article 19 and, if necessary, indicate the conditions, including the rules of conduct, under which, in the interest of the general good, that business must be carried on in the host Member State. 5. On receipt of a communication from the competent authorities of the host Member State or on the expiry of the period provided for in paragraph 4 without receipt of any communication from those authorities, the branch may be established and commence business. 6. In the event of a change in any of the particulars communicated in accordance with paragraph 2 (b), (c) or (d), an investment firm shall give written notice of that change to the competent authorities of the home and host Member States at least one month before implementing the change so that the competent authorities of the home Member State may take a decision on the change under paragraph 3 and the competent authorities of the host Member State may do so under paragraph 4. 7. In the event of a change in the particulars communicated in accordance with the second subparagraph of paragraph 3, the authorities of the home Member State shall inform the authorities of the host Member State accordingly. Article 18 1. Any investment firm wishing to carry on business within the territory of another Member State for the first time under the freedom to provide services shall communicate the following information to the competent authorities of its home Member State: - the Member State in which it intends to operate, - a programme of operations stating in particular the investment service or services which it intends to provide. 2. The competent authorities of the home Member State shall, within one month of receiving the information referred to in paragraph 1, forward it to the competent authorities of the host Member State. The investment firm may then start to provide the investment service or services in question in the host Member State. Where appropriate, the competent authorities of the host Member State shall, on receipt of the information referred to in paragraph 1, indicate to the investment firm the conditions, including the rules of conduct, with which, in the interest of the general good, the providers of the investment services in question must comply in the host Member State. 3. Should the content of the information communicated in accordance with the second indent of paragraph 1 be amended, the investment firm shall give notice of the amendment in writing to the competent authorities of the home Member State and of the host Member State before implementing the change, so that the competent authorities of the host Member State may, if necessary, inform the firm of any change or addition to be made to the information communicated under paragraph 2. Article 19 1. Host Member States may, for statistical purposes, require all investment firms with branches within their territories to report periodically on their activities in those host Member States to the competent authorities of those host Member States. In discharging their responsibilities in the conduct of monetary policy, without prejudice to the measures necessary for the strengthening of the European Monetary System, host Member States may within their territories require all branches of investment firms originating in other Member States to provide the same particulars as national investment firms for that purpose. 2. In discharging their responsibilities under this Directive, host Member States may require branches of investment firms to provide the same particulars as national firms for that purpose. Host Member States may require investment firms carrying on business within their territories under the freedom to provide services to provide the information necessary for the monitoring of their compliance with the standards set by the host Member State that apply to them, although those requirements may not be more stringent than those which the same Member State imposes on established firms for the monitoring of their compliance with the same standards. 3. Where the competent authorities of a host Member State ascertain that an investment firm that has a branch or provides services within its territory is in breach of the legal or regulatory provisions adopted in that State pursuant to those provisions of this Directive which confer powers on the host Member State's competent authorities, those authorities shall require the investment firm concerned to put an end to its irregular situation. 4. If the investment firm concerned fails to take the necessary steps, the competent authorities of the host Member State shall inform the competent authorities of the home Member State accordingly. The latter shall, at the earliest opportunity, take all appropriate measures to ensure that the investment firm concerned puts an end to its irregular situation. The nature of those measures shall be communicated to the competent authorities of the host Member State. 5. If, despite the measures taken by the home Member State or because such measures prove inadequate or are not available in the State in question, the investment firm persists in violating the legal or regulatory provisions referred to in paragraph 2 in force in the host Member State, the latter may, after informing the competent authorities of the home Member State, take appropriate measures to prevent or to penalize further irregularities and, in so far as necessary, to prevent that investment firm from initiating any further transactions within its territory. The Member States shall ensure that within their territories it is possible to serve the legal documents necessary for those measures on investment firms. 6. The foregoing provisions shall not affect the powers of host Member States to take appropriate measures to prevent or to penalize irregularities committed within their territories which are contrary to the rules of conduct introduced pursuant to Article 11 as well as to other legal or regulatory provisions adopted in the interest of the general good. This shall include the possibility of preventing offending investment firms from initiating any further transactions within their territories. 7. Any measure adopted pursuant to paragraphs 4, 5 or 6 involving penalties or restrictions on the activities of an investment firm must be properly justified and communicated to the investment firm concerned. Every such measure shall be subject to the right to apply to the courts in the Member State which adopted it. 8. Before following the procedure laid down in paragraphs 3, 4 or 5 the competent authorities of the host Member State may, in emergencies, take any precautionary measures necessary to protect the interests of investors and others for whom services are provided. The Commission and the competent authorities of the other Member States concerned must be informed of such measures at the earliest opportunity. After consulting the competent authorities of the Member States concerned, the Commission may decide that the Member State in question must amend or abolish those measures. 9. In the event of the withdrawal of authorization, the competent authorities of the host Member State shall be informed and shall take appropriate measures to prevent the investment firm concerned from initiating any further transactions within its territory and to safeguard investors' interests. Every two years the Commission shall submit a report on such cases to the committee set up at a later stage in the securities field. 10. The Member States shall inform the Commission of the number and type of cases in which there have been refusals pursuant to Article 17 or measures have been taken in accordance with paragraph 5. Every two years the Commission shall submit a report on such cases to the committee set up at a later date in the securities field. Article 20 1. In order to ensure that the authorities responsible for the markets and for supervision have access to the information necessary for the performance of their duties, home Member States shall at least require: (a) without prejudice to steps taken in implementation of Article 10, that investment firms keep at the disposal of the authorities for at least five years the relevant data on transactions relating to the services referred to in Article 14 (1) which they have carried out in instruments dealt in on a regulated market, whether such transactions were carried out on a regulated market or not; (b) that investment firms report to competent authorities in their home Member States all the transactions referred to in (a) where those transactions cover: - shares or other instruments giving access to capital, - bonds and other forms of securitized debt, - standardized forward contracts relating to shares or - standardized options on shares. Such reports must be made available to the relevant authority at the earliest opportunity. The time limit shall be fixed by that authority. It may be extended to the end of the following working day where operational or practical reasons so dictate but in no circumstances may it exceed that limit. Such reports must, in particular, include details of the names and numbers of the instruments bought or sold, the dates and times of the transactions, the transaction prices and means of identifying the investment firms concerned. Home Member States may provide that the obligation imposed in (b) shall, in the case of bonds and other forms of securitized debt, apply only to aggregated transactions in the same instrument. 2. Where an investment firm carries out a transaction on a regulated market in its host Member State, the home Member State may waive its own requirements as regards reporting if the investment firm is subject to equivalent requirements to report the transaction in question to the authorities in charge of that market. 3. Member States shall provide that the report referred to in paragraph 1 (b) shall be made either by the investment firm itself or by a trade-matching system, or through stock-exchange authorities or those of another regulated market. 4. Member States shall ensure that the information available in accordance with this Article is also available for the proper application of Article 23. 5. Each Member State may, in a non-discriminatory manner, adopt or maintain provisions more stringent in the field governed by this Article with regard to substance and form in respect of the conservation and reporting of data relating to transactions: - carried out on a regulated market of which it is the home Member State or - carried out by investment firms of which it is the home Member State. Article 21 1. In order to enable investors to assess at any time the terms of a transaction they are considering and to verify afterwards the conditions in which it has been carried out, each competent authority shall, for each of the regulated markets which it has entered on the list provided for in Article 16, take measures to provide investors with the information referred to in paragraph 2. In accordance with the requirements imposed in paragraph 2, the competent authorities shall determine the form in which and the precise time within which the information is to be provided, as well as the means by which it is to be made available, having regard to the nature, size and needs of the market concerned and of the investors operating on that market. 2. The competent authorities shall require for each instrument at least: (a) publication at the start of each day's trading on the market of the weighted average price, the highest and the lowest prices and the volume dealt in on the regulated market in question for the whole of the preceding day's trading; (b) in addition, for continuous order-driven and quote-driven markets, publication: - at the end of each hour's trading on the market, of the weighted average price and the volume dealt in on the regulated market in question for a six-hour trading period ending so as to leave two hours' trading on the market before publication, and - every 20 minutes, of the weighted average price and the highest and lowest prices on the regulated market in question for a two-hour trading period ending so as to leave one hour's trading on the market before publication. Where investors have prior access to information on the prices and quantities for which transactions may be undertaken: (i) such information shall be available at all times during market trading hours; (ii) the terms announced for a given price and quantity shall be terms on which it is possible for an investor to carry out such a transaction. The competent authorities may delay or suspend publication where that proves to be justified by exceptional market conditions or, in the case of small markets, to preserve the anonymity of firms and investors. The competent authorities may apply special provisions in the case of exceptional transactions that are very large in scale compared with average transactions in the security in question on that market and in the case of highly illiquid securities defined by means of objective criteria and made public. The competent authorities may also apply more flexible provisions, particularly as regards publication deadlines, for transactions concerning bonds and other forms of securitized debt. 3. In the field governed by this Article each Member State may adopt or maintain more stringent provisions or additional provisions with regard to the substance and form in which information must be made available to investors concerning transactions carried out on regulated markets of which it is the home Member State, provided that those provisions apply regardless of the Member State in which the issuer of the financial instrument is located or of the Member State on the regulated market of which the instrument was listed for the first time. 4. The Commission shall report on the application of this Article no later than 31 December 1997; the Council may, on a proposal from the Commission, decide by a qualified majority to amend this Article. TITLE VI Authorities responsible for authorization and supervision Article 22 1. Member States shall designate the competent authorities which are to carry out the duties provided for in this Directive. They shall inform the Commission thereof, indicating any division of those duties. 2. The authorities referred to in paragraph 1 must be either public authorities, bodies recognized by national law or bodies recognized by public authorities expressly empowered for that purpose by national law. 3. The authorities concerned must have all the powers necessary for the performance of their functions. Article 23 1. Where there are two or more competent authorities in the same Member State, they shall collaborate closely in supervising the activities of investment firms operating in that Member State. 2. Member States shall ensure that such collaboration takes place between such competent authorities and the public authorities responsible for the supervision of financial markets, credit and other financial institutions and insurance undertakings, as regards the entities which those authorities supervise. 3. Where, through the provision of services or by the establishment of branches, an investment firm operates in one or more Member States other than its home Member State the competent authorities of all the Member States concerned shall collaborate closely in order more effectively to discharge their respective responsibilities in the area covered by this Directive. They shall supply one another on request with all the information concerning the management and ownership of such investment firms that is likely to facilitate their supervision and all information likely to facilitate the monitoring of such firms. In particular, the authorities of the home Member State shall cooperate to ensure that the authorities of the host Member State collect the particulars referred to in Article 19 (2). In so far as it is necessary for the purpose of exercising their powers of supervision, the competent authorities of the home Member State shall be informed by the competent authorities of the host Member State of any measures taken by the host Member State pursuant to Article 19 (6) which involve penalties imposed on an investment firm or restrictions on an investment firm's activities. Article 24 1. Each host Member State shall ensure that, where an investment firm authorized in another Member State carries on business within its territory through a branch, the competent authorities of the home Member State may, after informing the competent authorities of the host Member State, themselves or through the intermediary of persons they instruct for the purpose carry out on-the-spot verification of the information referred to in Article 23 (3). 2. The competent authorities of the home Member State may also ask the competent authorities of the host Member State to have such verification carried out. Authorities which receive such requests must, within the framework of their powers, act upon them by carrying out the verifications themselves, by allowing the authorities who have requested them to carry them out or by allowing auditors or experts to do so. 3. This Article shall not affect the right of the competent authorities of a host Member State, in discharging their responsibilities under this Directive, to carry out on-the-spot verifications of branches established within their territory. Article 25 1. Member States shall provide that all persons who work or who have worked for the competent authorities, as well as auditors and experts instructed by the competent authorities, shall be bound by the obligation of professional secrecy. Accordingly no confidential information which they may receive in the course of their duties may be divulged to any person or authority whatsoever, save in summary or aggregate form such that individual investment firms cannot be identified, without prejudice to cases covered by criminal law. Nevertheless, where an investment firm has been declared bankrupt or is being compulsorily wound up, confidential information which does not concern third parties involved in attempts to rescue that investment firm may be divulged in civil or commercial proceedings. 2. Paragraph 1 shall not prevent the competent authorities of different Member States from exchanging information in accordance with this Directive or other Directives applicable to investment firms. That information shall be subject to the conditions of professional secrecy imposed in paragraph 1. 3. Member States may conclude cooperation agreements providing for exchanges of information with the competent authorities of third countries only if the information disclosed is covered by guarantees of professional secrecy at least equivalent to those provided for in this Article. 4. Competent authorities receiving confidential information under paragraph 1 or 2 may use it only in the course of their duties: - to check that the conditions governing the taking up of the business of investment firms are met and to facilitate the monitoring, on a non-consolidated or consolidated basis, of the conduct of that business, especially with regard to the capital adequacy requirements imposed in Directive 93/6/EEC, administrative and accounting procedures and internal-control mechanisms, - to impose sanctions, - in administrative appeals against decisions by the competent authorities, or - in court proceedings initiated under Article 26. 5. Paragraphs 1 and 4 shall not preclude the exchange of information: (a) within a Member State, where there are two or more competent authorities, or (b) within a Member State or between Member States, between competent authorities and - authorities responsible for the supervision of credit institutions, other financial organizations and insurance undertakings and the authorities responsible for the supervision of financial markets, - bodies responsible for the liquidation and bankruptcy of investment firms and other similar procedures and - persons responsible for carrying out statutory audits of the accounts of investment firms and other financial institutions, in the performance of their supervisory functions, or the disclosure to bodies which administer compensation schemes of information necessary for the performance of their functions. Such information shall be subject to the conditions of professional secrecy imposed in paragraph 1. 6. This Article shall not prevent a competent authority from disclosing to those central banks which do not supervise credit institutions or investment firms individually such information as they may need to act as monetary authorities. Information received in this context shall be subject to the conditions of professional secrecy imposed in paragraph 1. 7. This Article shall not prevent the competent authorities from communicating the information referred to in paragraphs 1 to 4 to a clearing house or other similar body recognized under national law for the provision of clearing or settlement services for one of their Member State's markets if they consider that it is necessary to communicate the information in order to ensure the proper functioning of those bodies in relation to defaults or potential defaults by market participants. The information received shall be subject to the conditions of professional secrecy imposed in paragraph 1. The Member States shall, however, ensure that information received under paragraph 2 may not be disclosed in the circumstances referred to in this paragraph without the express consent of the competent authorities which disclosed it. 8. In addition, notwithstanding the provisions referred to in paragraphs 1 and 4, Member States may, by virtue of provisions laid down by law, authorize the disclosure of certain information to other departments of their central government administrations responsible for legislation on the supervision of credit institutions, financial institutions, investment firms and insurance undertakings and to inspectors instructed by those departments. Such disclosures may, however, be made only where necessary for reasons of prudential control. Member States shall, however, provide that information received under paragraphs 2 and 5 and that obtained by means of the on-the-spot verifications referred to in Article 24 may never be disclosed in the cases referred to in this paragraph except with the express consent of the competent authorities which disclosed the information or of the competent authorities of the Member State in which the on-the-spot verification was carried out. 9. If, at the time of the adoption of this Directive, a Member State provides for the exchange of information between authorities in order to check compliance with the laws on prudential supervision, on the organization, operation and conduct of commercial companies and on the regulation of financial markets, that Member State may continue to authorize the forwarding of such information pending coordination of all the provisions governing the exchange of information between authorities for the entire financial sector but not in any case after 1 July 1996. Member States shall, however, ensure that, where information comes from another Member State, it may not be disclosed in the circumstances referred to in the first subparagraph without the express consent of the competent authorities which disclosed it and it may be used only for the purposes for which those authorities gave their agreement. The Council shall effect the coordination referred to in the first subparagraph on the basis of a Commission proposal. The Council notes the Commission's statement to the effect that it will submit proposals by 31 July 1993 at the latest. The Council will act on those proposals within the shortest possible time with the intention of bringing the rules proposed into effect on the same date as this Directive. Article 26 Member States shall ensure that decisions taken in respect of an investment firm under laws, regulations and administrative provisions adopted in accordance with this Directive are subject to the right to apply to the courts; the same shall apply where no decision is taken within six months of its submission in respect of an application for authorization which provides all the information required under the provisions in force. Article 27 Without prejudice to the procedures for the withdrawal of authorization or to the provisions of criminal law, Member States shall provide that their respective competent authorities may, with regard to investment firms or those who effectively control the business of such firms that infringe laws, regulations or administrative provisions concerning the supervision or carrying on of their activities, adopt or impose in respect of them measures or penalties aimed specifically at ending observed breaches or the causes of such breaches. Article 28 Member States shall ensure that this Directive is implemented without discrimination. TITLE VII Final provisions Article 29 Pending the adoption of a further Directive laying down provisions adapting this Directive to technical progress in the areas specified below, the Council shall, in accordance with Decision 87/373/EEC (15),20acting by a qualified majority on a proposal from the Commission, adopt any adaptations which may be necessary, as follows: - expansion of the list in Section C of the Annex, - adaptation of the terminology of the lists in the Annex to take account of developments on financial markets, - the areas in which the competent authorities must exchange information as listed in Article 23; - clarification of the definitions in order to ensure uniform application of this Directive in the Community, - clarification of the definitions in order to take account in the implementation of this Directive of developments on financial markets, - the alignment of terminology and the framing of definitions in accordance with subsequent measures on investment firms and related matters, - the other tasks provided for in Article 7 (5). Article 30 1. Investment firms already authorized in their home Member States to provide investment services before 31 December 1995 shall be deemed to be so authorized for the purpose of this Directive, if the laws of those Member States provide that to take up such activities they must comply with conditions equivalent to those imposed in Articles 3 (3) and 4. 2. Investment firms which are already carrying on business on 31 December 1995 and are not included among those referred to in paragraph 1 may continue their activities profided that, no later than 31 December 1996 and pursuant to the provisions of their home Member States, they obtain authorization to continue such activities in accordance with the provisions adopted in implementation of this Directive. Only the grant of such authorization shall enable such firms to qualify under the provisions of this Directive on the right of establishment and the freedom to provide services. 3. Where before the date of the adoption of this Directive investment firms have commenced business in other Member States either through branches or under the freedom to provide services, the authorities of each home Member State shall, between 1 July and 31 December 1995, communicate, for the purposes of Articles 17 (1) and (2) and 18, to the authorities of each of the other Member States concerned the list of firms that comply with this Directive and operate in those States, indicating the business carried on. 4. Natural persons authorized in a Member State on the date of the adoption of this Directive to offer investment services shall be deemed to be authorized under this Directive, provided that they fulfil the requirements imposed in Article 1 (2), second subparagraph, second indent, and third subparagraph, all four indents. Article 31 No later than 1 July 1995 Member States shall adopt the laws, regulations and administrative provisions necessary for them to comply with this Directive. These provisions shall enter into force no later than 31 December 1995. The Member States shall forthwith inform the Commission thereof. When Member States adopt the provisions referred to in the first paragraph they shall include a reference to this Directive or accompany them with such a reference on the occasion of their official publication. The manner in which such references are to be made shall be laid down by the Member States. Article 32 This Directive is addressed to the Member States.

31993L0028

1993

Commission Directive 93/28/EEC of 4 June 1993 amending Annex I to the third Directive 72/199/EEC establishing Community methods of analysis for the official control of feedingstuffs Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs (1), as last amended by the Act of Accession of Spain and Portugal (2), and in particular Article 2 thereof, Whereas the third Commission Directive 72/199/EEC of 27 April 1972 establishing Community methods of analysis for the official control of feedingstuffs (3), as last amended by Directive 84/4/EEC (4), specifies the method to be used for determining crude protein; Whereas the method should be amended to reflect advances in scientific and technical progress; whereas in particular the provisions of Council Directive 80/1107/EEC of 27 November 1980 on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (5), as amended by Directive 88/642/EEC (6), should be taken into account, in particular those on prevention of exposure to mercury and its compounds; Whereas it is accordingly necessary to remove mercury and mercuric oxide from the list of catalysts for use under the crude protein determination method; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs, Article 1 Annex I to Directive 72/199/EEC is hereby amended in accordance with the Annex to this Directive. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive as from 1 July 1994. They shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

31993L0026

1993

Commission Directive 93/26/EEC of 4 June 1993 amending Council Directive 82/471/EEC concerning certain products used in animal nutrition Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 82/471/EEC of 30 June 1992 concerning certain products used in animal nutrition (1), as last amended by Council Directive 90/654/EEC (2), and in particular Article 6 thereof, Whereas Directive 82/471/EEC provides for regular amendment of the content of the Annex thereto as a result of developments in scientific or technical knowledge; Whereas it has been found necessary to alter provisions concerning the declaration on the label of compound feedingstuffs of products in the Annex belonging to the group 'hydroxyanalogues of amino acids'; Whereas a new technique enables to protect amino acids in order to avoid their degradation in the rumen of dairy cows and therefore to increase the availability of these nutriments in the intestine; whereas the use of protected amino acids appeared particular benefic for the dairy cow, the use of these products in animal nutrition should, therefore, be permitted; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs, Article 1 The Annex to Directive 82/471/EEC is amended as set out in the Annex hereto. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 1 not later than 31 March 1994. They shall immediately inform the Commission thereof. When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

31993L0027

1993

Commission Directive 93/27/EEC of 4 June 1993 amending Council Directive 70/524/EEC concerning additives in feedingstuffs Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Commission Directive 92/113/EEC (2), and in particular Article 7 thereof, Whereas Directive 70/524/EEC provides for regular amendment of the content of its Annexes to take account of advances in scientific and technical knowledge; whereas the Annexes have been codified by Commission Directive 91/248/EEC (3); Whereas new uses of the antibiotic 'Avoparcin', of the coccidiostat 'Robendine', of the sweetener 'Neohesperidine dihydrochalcone' and of the thickener 'Cellulose powder' have been tested in certain Member States; whereas, on the basis of experience gained, it appears that these new uses can be authorized throughout the Community; Whereas a new use of the antibiotic 'Virginiamycin' has been successfully tested in certain Member States; whereas it is appropriate to authorize this new use at national level, while waiting for it to be authorized at Community level; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs, Article 1 The Annexes to Directive 70/524/EEC are hereby amended as set out in the Annex hereto. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 March 1994 at the latest. They shall immediately inform the Commission thereof. When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States.

31993L0038

1993

Council Directive 93/38/EEC of 14 June 1993 coordinating the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors Having regard to the Treaty establishing the European Economic Community, and in particular the last sentence of Articles 57 (2), 66, 100a and 113 thereof, Having regard to the proposal from the Commission(1) , In cooperation with the European Parliament(2) , Having regard of the opinion of the Economic and Social Committee(3) , 1. Whereas the measures aimed at progressively establishing the internal market during the period up to 31 December 1992 need to be taken; whereas the internal market consists of an area without internal frontiers in which free movement of goods, persons, services and capital is guaranteed; 2. Whereas restrictions on the free movement of goods and on freeedom to provide services in respect of supply and service contracts awarded in the water, energy, transport and telecommunications sectors are prohibited by the terms of Articles 30 and 59 of the EEC Treaty; 3. Whereas Article 97 of the Euratom Treaty prohibits any restrictions based on nationality as regards companies under the jurisdiction of a Member State where they desire to participate in the construction of nuclear installations of a scientific or industrial nature in the Community or to provide the relevant service in the Community; 4. Whereas these objectives also require the coordination of the procurement procedures applied by the entities operating in these sectors; 5. Whereas the White Paper on the completion of the internal market contains an action programme and a timetable for opening up public procurement markets in sectors which are currently excluded from Council Directive 71/305/EEC of 26 July 1971 concerning the coordination of procedures for the award of public works contracts(4) , and Council Directive 77/62/EEC of 21 December 1976 coordinating procedure for the award of public supply contracts(5) ; 6. Whereas the White Paper on the completion of the internal market also contains an action programme and a timetable for opening up service contracts; 7. Whereas among such excluded sectors are those concerning the provision of water, energy and transport services and, as far as Directive 77/62/EEC is concerned, the telecommunications sector; 8. Whereas the main reason for their exclusion was that entities providing such services are in some cases governed by public law, in others by private law; 9. Whereas the need to ensure a real opening-up of the market and a fair balance in the application of procurement rules in these sectors requires that the entities to be covered must be identified on a different basis than by reference to their legal status; 10. Whereas, in the four sectors concerned, the procurement problems to be solved are of a similar nature, thus permitting them to be addressed in one instrument; 11. Whereas, among the main reasons why entities operating in these sectors do not purchase on the basis of Community-wide competition is the closed nature of the markets in which they operate, due to the existence of special or exclusive rights granted by the national authorities, concerning the supply to, provision or operation of, networks for providing the service concerned, the exploitation of a given geographical area for a particular purpose, the provision or operation of public telecommunications networks or the provision of public telecommunications services; 12. Whereas the other main reason for the absence of Community-wide competition in these areas results from various ways in which national authorities can influence the behaviour of these entities, including participations in their capital and representation in the entities administrative, managerial or supervisory bodies; 13. Whereas this Directive should not extend to activities of those entities which either fall outside the sectors of water, energy and transport services or outside the telecommunications sector, or which fall within those sectors but are nevertheless directly exposed to competitive forces in markets to which entry is unrestricted; 14. Whereas it is appropriate that these entities apply common procurement procedures in respect of their activities relating to water; whereas certain entities have been covered up to now by Directives 71/305/EEC and 77/62/EEC in respect of their activities in the field of hydraulic engineering projects, irrigation, land drainage or the disposal and treatment of sewage; 15. Whereas, however, procurement rules of the type proposed for supplies of goods are inappropriate for purchases of water, given the need to procure water from sources near the area it will be used; 16. Whereas, when specific conditions are fulfilled, exploitation of a geographical area with the aim of exploring for or extracting oil, gas, coal or other solid fuels may be made subject to alternative arrangements which will enable the same objective of opening up contracts to be achieved; whereas the Commission must ensure that these conditions are complied with by the Member States who implement these alternative arrangements; 17. Whereas the Commission has announced that it will propose measures to remove obstacles to cross-frontier exchanges of electricity by 1992; whereas procurement rules of the type proposed for supplies of goods would not make it possible to overcome existing obstacles to the purchases of energy and fuels in the energy sector; whereas, as a result, it is not appropriate to include such purchases in the scope of this Directive, although it should be borne in mind that this exemption will be re-examined by the Council on the basis of a Commission report and Commission proposals; 18. Whereas Regulations (EEC) No 3975/87(6) and (EEC) No 3976/87(7) , Directive 87/601/EEC(8) and Decision 87/602/EEC(9) are designed to introduce more competition between the entities offering air transport services to the public and it is therefore not appropriate for the time being to include such entities in the scope of this Directive although the situation ought to be reviewed at a later stage in the light of progress made as regards competition; 19. Whereas, in view of the competitive position of Community shipping, it would be inappropriate for the greater part of the contracts in this sector to be subject to detailed procedures; whereas the situation of shippers operating sea-going ferries should be kept under review; whereas certain inshore and river ferry services operated by public authorities should no longer be excluded from the scope of Directives 71/305/EEC and 77/62/EEC; 20. Whereas it is appropriate to facilitate compliance with provisions relating to activities not covered by this Directive; 21. Whereas the rules on the award of service contracts should be as close as possible to the rules on the works and supply contracts referred to in this Directive; 22. Whereas obstacles to the free movement of services need to be avoided; whereas, therefore, service providers may be either natural or legal persons; whereas this Directive shall not, however, prejudice the application, at national level, of rules concerning the conditions for the pursuit of an activity or a profession provided that they are compatible with Community law; 23. Whereas the field of services is best described, for the purpose of application of procedural rules and for monitoring purposes, by subdividing the services into categories corresponding to particular positions of a common classification; whereas Annexes XVI A and XVI B to this Directive refer to the United Nations CPC (Central Product Classification) nomenclature; whereas that nomenclature is likely to be replaced by a Community nomenclature in the future; whereas it is necessary to make provision for the possibility of adapting the reference made to the CPC nomenclature in Annexes XVI A and XVI B accordingly; 24. Whereas the provision of services is covered by this Directive only in so far as it is based on contracts; whereas the provision of services on other bases, such as law, regulations or administrative provisions or employment contracts, is not covered; 25. Whereas, in accordance with Article 103f of the EEC Treaty, the encouragement of research and development is a means of strengthening the scientific and technological basis of European industry and the opening-up of public contracts will contribute to this end; whereas contributions to the financing of research programmes should not be subject to this Directive; whereas research and development service contracts other than those where the benefits accrue exclusively to the contracting authority for its use in the conduct of its own affairs, on condition that the service provided is wholly remunerated by the contracting authority, are not therefore covered by this Directive; 26. Whereas contracts for the acquisition or rental of land, existing buildings or other immovable property have particular characteristics, which make the application of procurement rules inappropriate; 27. Whereas arbitration and conciliation services are usually provided by bodies or individuals which are agreed on, or selected, in a manner which cannot be governed by procurement rules; 28. Whereas the service contracts covered by this Directive do not include contracts for the issue, purchase sale or transfer of securities or other financial instruments; 29. Whereas this Directive should not apply to procurement contracts which are declared secret or may affect basic State security interests or are concluded according to other rules set up by existing international agreements or international organizations; 30. Whereas contracts with a designated single source of supply may, under certain conditions, be fully or partly exempted from this Directive; 31. Whereas the Community's or the Member States' existing international obligations must not be affected by the rules of this Directive; 32. Whereas it is appropriate to exclude certain service contracts awarded to an affiliated undertaking having as its principal activity, with respect to services, the provision of such services to the group of which it is part, rather than the offering of its services on the market; 33. Whereas full application of this Directive must be limited, for a transitional period, to contracts for those services where its provisions will enable the full potential for increased cross-frontier trade to be realized; whereas contracts for other services need to be monitored for a certain period before taking a decision on the full application of the said Directive; whereas the mechanism for such monitoring needs to be set up by this Directive and whereas it should at the same time enable those interested to share the relevant information; 34. Whereas the relevant Community rules on mutual recognition of diplomas, certificates or other evidence of formal qualifications apply when evidence of a particular qualification is required for participation in an award procedure or a design contest; 35. Whereas products, works or services must be described by reference to European specifications; whereas, in order to ensure that a product, work or service fulfils the use for which it is intended by the contracting entity, such reference may be complemented by specifications which do not change the nature of the technical solution or solutions set out in the European specification; 36. Whereas the principles of equivalence and of mutual recognition of national standards, technical specifications and manufacturing methods are applicable in the field of application of this Directive; 37. Whereas Community undertakings should be granted access to the award of service contracts in third countries; whereas the Community should endeavour to remedy any situation whereby such access, in law or in fact, is found to be restricted and whereas it should be possible, under certain conditions, to take measures as regards access to service contracts covered by this Directive for undertakings of the third country concerned or for tenders originating in that country; 38. Whereas, when the contracting entities define by common accord with tenderers the deadlines for receiving tenders, they shall comply with the principles of non-discrimination, and whereas, if there is no such agreement, it is necessary to lay down suitable provisions; 39. Whereas it could prove useful to provide for greater transparency as to the requirements regarding the protection and conditions of employment applicable in the Member State in which the works are to be carried out; 40. Whereas it is appropriate that national provisions for regional development requirements to be taken into consideration in the award of public contracts should be made to conform to the objectives of the Community and be in keeping with the principles of the EEC Treaty; 41. Whereas contracting entities must not be able to reject abnormally low tenders before having requested in writing explanations as to the constituent elements of the tender; 42. Whereas, within certain limits, preference should be given to an offer of Community origin where there are equivalent offers of third-country origin; 43. Whereas this Directive should not prejudice the position of the Community in any current or future international negotiations; 44. Whereas, based on the results of such international negotiations, this Directive should be extendable to offers of third-country origin, pursuant to a Council Decision; 45. Whereas the rules to be applied by the entities concerned should establish a framework for sound commercial practice and should leave a maximum of flexibility; 46. Whereas, as a counterpart for such flexibility and in the interest of mutual confidence, a minimum level of transparency must be ensured and appropriate methods adopted for monitoring the application of this Directive; 47. Whereas it is necessary to adapt Directives 71/305/EEC and 77/62/EEC to establish well-defined fields of application; whereas the scope of Directive 71/305/EEC should not be reduced, except as regards contracts in the water and telecommunications sectors; whereas the scope of Directive 77/62/EEC should not be reduced, except as regards certain contracts in the water sector; whereas the scope of Directives 71/305/EEC and 77/62/EEC should not, however, be extended to contracts awarded by carriers by land, air, sea, inshore or inland waterway which, although carrying out economic activities of an industrial or commercial nature, belong to the State administration; whereas, nevertheless, certain contracts awarded by carriers by land, air, sea, inshore or inland waterway which belong to the State administration and are carried out only for reasons of public service should be covered by those Directives; 48. Whereas this Directive should be re-examined in the light of experience; 49. Whereas the opening-up of contracts in the sectors covered by this Directive might have an adverse effect upon the economy of the Kingdom of Spain; whereas the economies of the Hellenic Republic and the Portuguese Republic will have to sustain even greater efforts; whereas it is appropriate that these Member States be granted adequate additional periods to implement this Directive, TITLE I General provisions Article 1 For the purpose of this Directive: 1. 'public authorities' shall mean the State, regional or local authorities, bodies governed by public law, or associations formed by one or more of such authorities or bodies governed by public law. A body is considered to be governed by public law where it: - is established for the specific purpose of meeting needs in the general interest, not being of an industrial or commercial nature, - has legal personality, and - is financed for the most part by the State, or regional or local authorities, or other bodies governed by public law, or is subject to management supervision by those bodies, or has an administrative, managerial or supervisory board more than half of whose members are appointed by the State, regional or local authorities, or other bodies governed by public law; 2. 'public undertaking' shall mean any undertaking over which the public authorities may exercise directly or indirectly a dominant influence by virtue of their ownership of it, their financial participation therein, or the rules which govern it. A dominant influence on the part of the public authorities shall be presumed when these authorities, directly or indirectly, in relation to an undertaking: - hold the majority of the undertaking's subscribed capital, or - control the majority of the votes attaching to shares issued by the undertaking, or - can appoint more than half of the members of the undertaking's administrative, managerial or supervisory body; 3. 'affiliated undertaking' shall mean any undertaking the annual accounts of which are consolidated with those of the contracting entity in accordance with the requirements of the seventh Council Directive 83/349/EEC of 13 June 1983, based on Article 54 (3) (g) of the EEC Treaty on consolidated accounts(10) or, in the case of entities not subject to that Directive, any undertaking over which the contracting entity may exercise, directly or indirectly, a dominant influence within the meaning of paragraph 2, or which may exercise a dominant influence over the contracting entity or which, in common with the contracting entity, is subject to the dominant influence of another undertaking by virtue of ownership, financial participation, or the rules which govern it; 4. 'supply, works and service contracts' shall mean contracts for pecuniary interest concluded in writing between one of the contracting entities referred to in Article 2, and a supplier, a contractor or a service provider, having as their object: (a) in the case of supply contracts, the purchase, lease, rental or hire-purchase, with or without options to buy, of products; (b) in the case of works contracts either the execution, or both the execution and design or the realization, by whatever means, of building or civil engineering activities referred to in Annex XI. These contracts may, in addition, cover supplies and services necessary for their execution; (c) in the case of service contracts, any object other than those referred to in (a) and (b) and to the exclusion of: (i) contracts for the acquisition or rental, by whatever financial means, of land, existing buildings, or other immovable property or concerning rights thereon; nevertheless, financial service contracts concluded at the same time as, before or after the contract of acquisition or rental, in whatever form, shall be subject to this Directive; (ii) contracts for voice telephony, telex, radiotelephony, paging and satellite services; (iii) contracts for arbitration and conciliation services; (iv) contracts for the issue, sale, purchase or transfer of securities or other financial instruments; (v) employment contracts; (vi) research and development service contracts other than those where the benefits accrue exclusively to the contracting entity for its use in the conduct of its own affairs, on condition that the service provided is wholly remunerated by the contracting entity. Contracts which include the provision of services and supplies shall be regarded as supply contracts if the total value of supplies is greater than the value of the services covered by the contract; 5. 'framework agreement' shall mean an agreement between one of the contracting entities defined in Article 2 and one or more suppliers, contractors or service providers the purpose of which is to establish the terms, in particular with regard to the prices and, where appropriate, the quantity envisaged, governing the contracts to be awarded during a given period; 6. 'tenderer' shall mean a supplier, contractor or service provider who submits a tender and 'candidate' shall mean a person who has sought an invitation to take part in a restricted or negotiated procedure; service providers may be either natural or legal persons, including contracting entities within the meaning of Article 2; 7. 'open, restricted and negotiated procedures' shall mean the award procedures applied by contracting entities whereby: (a) in the case of open procedures, all interested suppliers, contractors or service providers may submit tenders; (b) in the case of the restricted procedures, only candidates invited by the contracting entity may submit tenders; (c) in the case of negotiated procedures, the contracting entity consults suppliers, contractors or service providers of its choice and negotiates the terms of the contract with one or more of them; 8. 'technical specifications' shall mean the technical requirements contained in particular in the tender documents, defining the characteristics of a set of works, material, product, supply or service, and enabling a piece of work, a material, a product, a supply or a service to be objectively described in a manner such that it fulfils the use for which it is intended by the contracting entity. These technical specifications may include quality, performance, safety or dimensions, as well as requirements applicable to the material, product, supply or service as regards quality assurance, terminology, symbols, testing and test methods, packaging, marking or labelling. In the case of works contracts, they may also include rules for the design and costing, the test, inspection and acceptance conditions for works and techniques or methods of construction and all other technical conditions which the contracting entity is in a position to prescribe under general or specific regulations, in relation to the finished works and to the materials or parts which they involve; 9. 'standard' shall mean a technical specification approved by a recognized standardizing body for repeated or continuous application, compliance with which is in principle not compulsory; 10. 'European standard' shall mean a standard approved by the European Committee for Standardization (CEN) or by the European Committee for Electrotechnical Standardization (Cenelec) as a 'European Standard (EN)' or 'Harmonization Document (HD)', according to the common rules of those organizations, or by the European Telecommunications Standards Institute (ETSI) according to its own rules as a 'European Telecommunications Standard (ETS)'; 11. 'common technical specification' shall mean a technical specification drawn up in accordance with a procedure recognized by the Member States with a view to uniform application in all Member States and published in the Official Journal of the European Communities; 12. 'European technical approval' shall mean a favourable technical assessment of the fitness for use of a product for a particular purpose, based on fulfilment of the essential requirements for building works, by means of the inherent characteristics of the product and the defined conditions of application and use, as provided for in Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products(11) . European technical approval shall be issued by an approval body designated for this purpose by the Member State; 13. 'European specification' shall mean a common technical specification, a European technical approval or a national standard implementing a European standard; 14. 'public telecommunications network' shall mean the public telecommunications infrastructure which enables signals to be conveyed between defined network termination points by wire, by microwave, by optical means or by other electromagnetic means; 'network termination point' shall mean all physical connections and their technical access specification which form part of the public telecommunications network and are necessary for access to, and efficient communication through, that public network; 15. 'public telecommunications services' shall mean telecommunications services the provision of which the Member States have specifically assigned notably to one or more telecommunications entities; 'Telecommunications services' shall mean services the provision of which consists wholly or partly in the transmission and routing of signals on the public telecommunications network by means of telecommunications processes, with the exception of radio-broadcasting and television; 16. 'design contests' shall mean the national procedures which enable the contracting entity to acquire, mainly in the fields of architecture, engineering or data processing, a plan or design selected by a jury after having been put out to competition with or without the award of prizes. Article 2 1. This Directive shall apply to contracting entities which: (a) are public authorities or public undertakings and exercise one of the activities referred to in paragraph 2; (b) when they are not public authorities or public undertakings, have as one of their activities any of those referred to in paragraph 2 or any combination thereof and operate on the basis of special or exclusive rights granted by a competent authority of a Member State. 2. Relevant activities for the purposes of this Directive shall be: (a) the provision or operation of fixed networks intended to provide a service to the public in connection with the production, transport or distribution of: (i) drinking water; or (ii) electricity; or (iii) gas or heat; or the supply of drinking water, electricity, gas or heat to such networks; (b) the exploitation of a geographical area for the purpose of: (i) exploring for or extracting oil, gas, coal or other solid fuels, or (ii) the provision of airport, maritime or inland port or other terminal facilities to carriers by air, sea or inland waterway; (c) the operation of networks providing a service to the public in the field of transport by railway, automated systems, tramway, trolley bus, bus or cable. As regards transport services, a network shall be considered to exist where the service is provided under operating conditions laid down by a competent authority of a Member State, such as conditions on the routes to be served, the capacity to be made available or the frequency of the service; (d) the provision or operation of public telecommunications networks or the provision of one or more public telecommunications services. 3. For the purpose of applying paragraph 1 (b), special or exclusive rights shall mean rights deriving from authorizations granted by a competent authority of the Member State concerned, by law, regulation or administrative action, having as their result the reservation for one or more entities of the exploitation of an activity defined in paragraph 2. A contracting entity shall be considered to enjoy special or exclusive rights in particular where: (a) for the purpose of constructing the networks or the facilities referred to in paragraph 2, it may take advantage of a procedure for the expropriation or use of property or may place network equipment on, under or over the public highway; (b) in the case of paragraph 2 (a), the entity supplies with drinking water, electricity, gas or heat a network which is itself operated by an entity enjoying special or exclusive rights granted by a competent authority of the Member State concerned. 4. The provision of bus transport services to the public shall not be considered to be a relevant activity within the meaning of paragraph 2 (c) where other entities are free to provide those services, either in general or in a particular geographical area, under the same condition as the contracting entities. 5. The supply of drinking water, electricity, gas or heat to networks which provide a service to the public by a contracting entity other than a public authority shall not be considered as a relevant activity within the meaning of paragraph 2 (a) where: (a) in the case of drinking water or electricity: - the production of drinking water or electricity by the entity concerned takes place because its consumption is necessary for carrying out an activity other than that referred to in paragraph 2, and - supply to the public network depends only on the entity's own consumption and has not exceeded 30 % of the entity's total production of drinking water or energy, having regard to the average for the preceding three years, including the current year; (b) in the case of gas or heat: - the production of gas or heat by the entity concerned is the unavoidable consequence of carrying on an activity other than that referred to in paragraph 2, and - supply to the public network is aimed only at the economic exploitation of such production and amounts to not more than 20 % of the entity's turnover having regard to the average for the preceding three years, including the current year. 6. The contracting entities listed in Annexes I to X shall fulfil the criteria set out above. In order to ensure that the lists are as exhaustive as possible, Member States shall notify the Commission of amendments to their lists. The Commission shall revise Annexes I to X in accordance with the procedure in Article 40. Article 3 1. Member States may request the Commission to provide that exploitation of geographical areas for the purpose of exploring for or extracting oil, gas, coal or other solid fuels shall not be considered to be an activity defined in Article 2 (2) (b) (i) and that entities shall not be considered as operating under special or exclusive rights within the meaning of Article 2 (3) (b) by virtue of carrying on one or more of these activities, provided that all the following conditions are satisfied with respect to the relevant national provisions concerning such activities: (a) at the time when authorization to exploit such a geographical area is requested, other entities shall be free to seek authorization for that purpose under the same conditions as the contracting entities; (b) the technical and financial capacity of entities to engage in particular activities shall be established prior to any evaluation of the merits of competing applications for authorization; (c) authorization to engage in those activities shall be granted on the basis of objective criteria concerning the way in which it is intended to carry out exploitation or extraction, which shall be established and published prior to the requests and applied in a non-discriminatory manner; (d) all conditions and requirements concerning the carrying out or termination of the activity, including provisions on operating obligations, royalties, and participation in the capital or revenue of the entities, shall be established and made available prior to the requests for authorization being made and then applied in a non-discriminatory manner; every change concerning these conditions and requirements shall be applied to all the entities concerned, or else amendments must be made in a non-discriminatory manner; however, operating obligations need not be established until immediately before the authorization is granted; and (e) contracting entities shall not be required by any law, regulation, administrative requirement, agreement or understanding to provide information on a contracting entity's intended or actual sources of procurement, except at the request of national authorities with a view to the objectives mentioned in Article 36 of the EEC Treaty. 2. Member States which apply the provisions of paragraph 1 shall ensure, through the conditions of the authorization or other appropriate measures, that any entity: (a) observes the principles of non-discrimination and competitive procurement in respect of the award of supplies, works and service contracts, in particular as regards the information which the entity makes available to undertakings concerning its procurement intentions; (b) communicates to the Commission, under conditions to be defined by the latter in accordance with Article 40, information relating to the award of contracts. 3. As regards individual concessions or authorizations granted before the date on which Member States apply this Directive in accordance with Article 45, paragraph 1 (a), (b) and (c) shall not apply, provided that at that date other entities are free to seek authorization for the exploitation of geographical areas for the purpose of exploring for or extracting oil, gas, coal or other solid fuels, on a non-discriminatory basis and in the light of objective criteria. Paragraph 1 (d) shall not apply as regards conditions or requirements established, applied or amended before the date referred to above. 4. A Member State which wishes to apply paragraph 1 shall inform the Commission accordingly. In so doing, it shall inform the Commission of any law, regulation or administrative provision, agreement or understanding relating to compliance with the conditions referred to in paragraphs 1 and 2. The Commission shall take a decision in accordance with the procedure laid down in Article 40 (5) to (8). It shall publish its decision, giving its reasons, in the Official Journal of the European Communities. It shall forward to the Council each year a report on the implementation of this Article and review its application in the framework of the report provided for in Article 44. Article 4 1. When awarding supply, works or service contracts, or organizing design contests, the contracting entities shall apply procedures which are adapted to the provisions of this Directive. 2. Contracting entities shall ensure that there is no discrimination between different suppliers, contractors or service providers. 3. In the context of provision of technical specifications to interested suppliers, contractors or service providers, of qualification and selection of suppliers, contractors or service providers and of award of contracts, contracting entities may impose requirements with a view to protecting the confidential nature of information which they make available. 4. This Directive shall not limit the right of suppliers, contractors or service providers to require a contracting entity, in conformity with national law, to respect the confidential nature of information which they make available. Article 5 1. Contracting entities may regard a framework agreement as a contract within a meaning of Article 1 (4) and award it in accordance with this Directive. 2. Where contracting entities have awarded a framework agreement in accordance with this Directive, they may avail themselves of Article 20 (2) (i) when awarding contracts based on that agreement. 3. Where a framework agreement has not been awarded in accordance with this Directive, contracting entities may not avail themselves of Article 20 (2) (i). 4. Contracting entities may not misuse framework agreements in order to hinder, limit or distort competition. Article 6 1. This Directive shall not apply to contracts or design contests which the contracting entities award or organize for purposes other than the pursuit of their activities as described in Article 2 (2) or for the pursuit of such activities in a non-member country, in conditions not involving the physical use of a network or geographical area within the Community. 2. However, this Directive shall apply to contracts or design contests awarded or organized by the entities which exercise an activity referred to in Article 2 (2) (a) (i) and which: (a) are connected whith hydraulic engineering projects, irrigation or land drainage, provided that the volume of water intended for the supply of drinking water represents more than 20 % of the total volume of water made available by these projects or irrigation or drainage installations, or (b) are connected with the disposal or treatment of sewage. 3. The contracting entities shall notify the Commission at its request of any activities they regard as excluded under paragraph 1. The Commission may periodically publish lists of the categories of activities which it considers to be covered by this exclusion for information in the Official Journal of the European Communities. In so doing, the Commission shall respect any sensitive commercial aspects the contracting entities may point out when forwarding this information. Article 7 1. This Directive shall not apply to contracts awarded for purposes of resale or hire to third parties, provided that the contracting entity enjoys no special or exclusive right to sell or hire the subject of such contracts and other entities are free to sell or hire it under the same conditions as the contracting entity. 2. The contracting entities shall notify the Commission at its request of all the categories of products or activities which they regard as excluded under paragraph 1. The Commission may periodically publish lists of the categories of products of activities which it considers to be covered by this exclusion for information in the Official Journal of the European Communities. In so doing, the Commission shall respect any sensitive commercial aspects which the contracting entities may point out when forwarding this information. Article 8 1. This Directive shall not apply to contracts which contracting entities exercising an activity described in Article 2 (2) (d) award for purchases intended exclusively to enable them to provide one or more telecommunications services where other entities are free to offer the same services in the same geographical area and under substantially the same conditions. 2. The contracting entities shall notify the Commission at its request of any services which they regard as excluded under paragraph 1. The Commission may periodically publish the list of services which it considers to be covered by this exclusion for information in the Official Journal of the European Communities. In so doing, the Commission shall respect any sensitive commercial aspects the contracting entities may point out when forwarding this information. Article 9 1. This Directive shall not apply to: (a) contracts which the contracting entities listed in Annex I award for the purchase of water; (b) contracts which the contracting entities listed in Annexes II to V award for the supply of energy or of fuels for the production of energy. 2. The Council shall re-examine the provisions of paragraph 1 when it has before it a report from the Commission together with appropriate proposals. Article 10 This Directive shall not apply to contracts when they are declared to be secret by Member States, when their execution must be accompanied by special security measures in accordance with the laws, regulations or administrative provisions in force in the Member State concerned or when the protection of the basic security interests of that State so requires. Article 11 This Directive shall not apply to service contracts awarded to an entity which is itself a contracting authority within the meaning of Article 1 (b) of Council Directive 92/50/EEC of 18 June 1992 relating to the coordination of procedures for the award of public service contracts (12) on the basis of an exclusive right which it enjoys pursuant to a published law, regulation or administrative provision which is compatible with the EEC Treaty. Article 12 This Directive shall not apply to contracts governed by different procedural rules and awarded: 1. pursuant to an international agreement concluded in conformity with the Treaty between a Member State and one or more third countries and covering supplies, works, services or design contests intended for the joint implementation or exploitation of a project by the signatory States; every agreement shall be communicated to the Commission, which may consult the Advisory Committee for Public Contracts set up by Council Decision 71/306/EEC (13) or, in the case of agreements governing contracts awarded by entities exercising an activity defined in Article 2 (2) (d), the Advisory Committee on Telecommunications Procurement referred to in Article 39; 2. to undertakings in a Member State or a third country in pursuance of an international agreement relating to the stationing of troops; 3. pursuant to the particular procedure of an international organization. Article 13 1. This Directive shall not apply to service contracts which: (a) a contracting entity awards to an affiliated undertaking; (b) are awarded by a joint venture formed by a number of contracting entities for the purpose of carrying out a relevant activity within the meaning of Article 2 (2) to one of those contracting entities or to an undertaking which is affiliated with one of these contracting entities, provided that at least 80 % of the average turnover of that undertaking with respect to services arising within the Community for the preceding three years derives from the provision of such services to undertakings with which it is affiliated. Where more than one undertaking affiliated with the contracting entity provides the same service or similar services, the total turnover deriving from the provision of services by those undertakings shall be taken into account. 2. The contracting entities shall notify to the Commission, at its request, the following information regarding the application of the provisions of paragraph 1: - the names of the undertakings concerned, - the nature and value of the service contracts involved, - such proof as may be deemed necessary by the Commission that the relationship between the undertaking to which the contracts are awarded and the contracting entity is in conformity with the requirements of this Article. Article 14 1. This Directive shall apply to contracts the estimated value, not of VAT, for which is not less than: (a) ECU 400 000 in the case of supply and service contracts awarded by entities exercising an activity defined in Article 2 (2) (a), (b) and (c); (b) ECU 600 000 in the case of supply and service contracts awarded by entities carrying out an activity defined in Article 2 (2) (d); (c) ECU 5 000 000 in the case of works contracts. 2. For the purposes of calculating the estimated amount of a service contract, the contracting entity shall include the total remuneration of the service provider, taking account of the elements specified in paragraphs 3 to 13. 3. For the purposes of calculating the estimated contract amount of financial services, the following amounts shall be taken into account: - as regards insurance services, the premium payable, - as regards banking and other financial services, fees, commissions, interest and other types of remuneration, - as regards contracts which involve design, the fee or commission payable. 4. In the case of supply contracts for lease, rental or hire-purchase, the basis for calculating the contract value shall be: (a) in the case of fixed-term contracts, where their term is 12 months or less, the estimated total value for the contract's duration, or, where their term exceeds 12 months, the contract's total value including the estimated residual value; (b) in the case of contracts for an indefinite period or in cases where there is doubt as to the duration of the contracts, the anticipated total instalments to be paid in the first four years. 5. In the case of service contracts which do not indicate a total cost, the basis for calculating the estimated contract value shall be: - for fixed-term contracts, where their term is 48 months or less, the total value for their whole duration, - for contracts without a fixed term or for a term exceeding 48 months, the monthly value multiplied by 48. 6. Where a proposed supply or service contract expressly specifies option clauses, the basis for calculating the contract value shall be the highest possible total purchase, lease, rental or hire-purchase permissible, inclusive of the option clauses. 7. In the case of a procurement of supplies or services over a given period by means of a series of contracts to be awarded to one or more suppliers or service providers or of contracts which are to be renewed, the contract value shall be calculated on the basis of: (a) the total value of contracts with similar characteristics which were awarded over the previous financial year or 12 months, adjusted where possible for anticipated changes in quantity or value over the subsequent twelve months; or (b) the aggregate value of contracts to be awarded during the 12 months following the first award or during the whole term of the contract, where this is longer than 12 months. 8. The basis for calculating the estimated value of a contract including both supplies and services shall be the total value of the supplies and services, regardless of their respective values. The calculation shall include the value of the siting and installation operations. 9. The basis for calculating the value of a framework agreement shall be the estimated maximum value of all the contracts envisaged for the period in question. 10. The basis for calculating the value of a works contract for the purposes of paragraph 1 shall be the total value of the work. 'Work' shall mean the result of building and civil engineering activities, taken as a whole, which are intended to fulfil an economic and technical function by themselves. In particular, where a supply, work or service is the subject of several lots, the value of each lot shall be taken into account when assessing the value referred to in paragraph 1. Where the aggregate value of the lots equals or exceeds the value laid down in paragraph 1, that paragraph shall apply to all the lots. However, in the case of works contracts, contracting entities may derogate from paragraph 1 in respect of lots the estimated value net of VAT for which is less than ECU 1 million, provided that the aggregate value of those lots does not exceed 20 % of the overall value of the lots. 11. For the purposes of paragraph 1, contracting entities shall include in the estimated value of a works contract the value of any supplies or services necessary for the execution of the contracts which they make available to the contractor. 12. The value of supplies or services which are not necessary for the execution of a particular works contract may not be added to that of the works contract with the result of avoiding application of this Directive to the procurement of those supplies or services. 13. Contracting entities may not circumvent this Directive by splitting contracts or using special methods of calculating the value of contracts. TITLE II Two-tier application Article 15 Supply and works contracts and contracts which have as their object services listed in Annex XVI A shall be awarded in accordance with the provisions of Titles III, IV and V. Article 16 Contracts which have as their object services listed in Annex XVI B shall be awarded in accordance with Articles 18 and 24. Article 17 Contracts which have as their object services listed in both Annexes XVI A and XVI B shall be awarded in accordance with the provisions of Titles III, IV and V where the value of the services listed in Annex XVI A is greater than the value of the services listed in Annex XVI B. Where this is not the case, they shall be awarded in accordance with Articles 18 and 24. TITLE III Technical specifications and standards Article 18 1. Contracting entities shall include the technical specifications in the general documents or the contract documents relating to each contract. 2. The technical specifications shall be defined by reference to European specifications, where these exist. 3. In the absence of European specifications, the technical specifications should as far as possible be defined by reference to other standards having currency within the Community. 4. Contracting entities shall define such further requirements as are necessary to complete European specifications or other standards. In so doing, they shall prefer specifications which indicate performance requirements rather than design or description characteristics, unless the contracting entity has objective reasons for considering that such specifications are inadequate for the purposes of the contract. 5. Technical specifications which mention goods of a specific make or source or of a particular process, and which have the effect of favouring or eliminating certain undertakings, shall not be used unless such specifications are indispensable for the subject of the contract. In particular, the indication of trade marks, patents, types, of specific origin or production shall be prohibited; however, such an indication accompanied by the works 'or equivalent' shall be authorized where the subject of the contract cannot otherwise be described by specifications which are sufficiently precise and fully intelligible to all concerned. 6. Contracting entities may derogate from paragraph 2 if: (a) it is technically impossible to establish satisfactorily that a product conforms to the European specifications; (b) the application of paragraph 2 would prejudice the application of Council Directive 86/361/EEC of 24 July 1986 on the initial stage of the mutual recognition of type approval for telecommunications terminal equipment(14) , or of Council Decision 87/95/EEC of 22 December 1986 on standardization in the field of information technology and telecommunications(15) ; (c) in the context of adapting existing practice to take account of European specifications, use of those specifications would oblige the contracting entity to acquire supplies incompatible with equipment already in use or would entail disproportionate cost or disproportionate technical difficulty. Contracting entities which have recourse to this derogation shall do so only as part of clearly-defined and recorded strategy with a view to a changeover to European specifications; (d) the relevant European specification is inappropriate for the particular application or does not take account of technical developments which have come about since its adoption. Contracting entities which have recourse to this derogation shall inform the appropriate standardizing organization, or any other body empowered to review the European specification, of the reasons why they consider the European specification to be inappropriate and shall request its revision; (e) the project is of a genuinely innovative nature for which use of European specifications would not be appropriate. 7. Notices published pursuant to Article 21 (1) (a) or Article 21 (2) (a) shall indicate any recourse to the derogations referred to in paragraph 6. 8. This Article shall be without prejudice to compulsory technical rules in so far as these are compatible with Community law. Article 19 1. Contracting entities shall make available on request to suppliers, contractors or service providers interested in obtaining a contract the technical specifications regularly referred to in their supply, works or service contracts or the technical specifications which they intend to apply to contracts covered by periodic information notices within the meaning of Article 22. 2. Where such technical specifications are based on documents available to interested suppliers, contractors or service providers, a reference to those documents shall be sufficient. TITLE IV Procedures for the award of contracts Article 20 1. Contracting entities may choose any of the procedures described in Article 1 (7), provided that, subject to paragraph 2, a call for competition has been made in accordance with Article 21. 2. Contracting entities may use a procedure without prior call for competition in the following cases: (a) in the absence of tenders or suitable tenders in response to a procedure with a prior call for competition, provided that the original contract conditions have not been substantially changed; (b) where a contract is purely for the purpose of research, experiment, study or development and not for the purpose of ensuring profit or of recovering research and development costs and in so far as the award of such contract does not prejudice the competitive award of subsequent contracts which have in particular these purposes; (c) when, for technical or artistic reasons or for reasons connected with protection of exclusive rights, the contract may be executed only by a particular supplier, contractor or service provider; (d) in so far as is strictly necessary when, for reasons of extreme urgency brought about by events unforeseeable by the contracting entities, the time limits laid down for open and restricted procedures cannot be adhered to; (e) in the case of supply contracts for additional deliveries by the original supplier which are intended either as a partial replacement of normal supplies or installations or as the extension of existing supplies or installations, where a change of supplier would oblige the contracting entity to acquire material having different technical characteristics which would result in incompatibility or disproportionate technical difficulties in operation and maintenance; (f) for additional works or services not included in the project initially awarded or in the contract first concluded but which have, through unforeseen circumstances, become necessary for the execution of the contract, on condition that the award is made to the contractor or service provider executing the original contract: - when such additional works or services cannot be technically or economically separated from the main contract without great inconvenience to the contracting entities, - or when such additional works or services, although separable from the execution of the original contract, are strictly necessary to its later stages; (g) in the case of works contracts, for new works consisting of the repetition of similar works entrusted to the contractor to which the same contracting entities awarded an earlier contract, provided that such works conform to a basic project for which a first contract was awarded after a call for competition. As soon as the first project is put up for tender, notice must be given that this procedure might be adopted and the total estimated cost of subsequent works shall be taken into consideration by the contracting entities when they apply the provisions of Article 14; (h) for supplies quoted and purchased on a commodity market; (i) for contracts to be awarded on the basis of a framework agreement, provided that the condition referred to in Article 5 (2) is fulfilled; (j) for bargain purchases, where it is possible to procure supplies taking advantage of a particularly advantageous opportunity available for a very short space of time at a price considerably lower than normal market prices; (k) for purchases of goods under particularly advantageous conditions from either a supplier definitively winding up his business activities or the receivers or liquidators of a bankruptcy, an arrangement with creditors or a similar procedure under national laws or regulations; (l) when the service contract concerned is part of the follow-up a design contest organized in conformity with the provisions of this Directive and must, in accordance with the relevant rules, be awarded to the winner or to one of the winners of that contest. In the latter case, all the winners must be invited to participate in the negotiations. Article 21 1. In the case of supplies, works or service contracts, the call for competition may be made: (a) by means of a notice drawn up in accordance with Annex XII A, B or C; or (b) by means of a periodic indicative notice drawn up in accordance with Annex XIV; or (c) by means of a notice on the existence of a qualification system drawn up in accordance with Annex XIII. 2. When a call for competition is made by means of a periodic indicative notice: (a) the notice must refer specifically to the supplies, works or services which will be the subject of the contract to be awarded; (b) the notice must indicate that the contract will be awarded by restricted or negotiated procedure without further publication of a notice of a call for competition and invite interested undertakings to express their interest in writing; (c) contracting entities shall subsequently invite all candidates to confirm their interest on the basis of detailed information on the contract concerned before beginning the selection of tenderers or participants in negotiations. 2. When a call for competition is made by means of a notice on the existence of a qualification system, tenderers in a restricted procedure or participants in a negotiated prcedure shall be selected from the qualified candidates in accordance with such a system. 4. In the case of design contests, the call for competition shall be made by means of a notice drawn up in accordance with Annex XVII. 5. The notices referred to in this Article shall be published in the Official Journal of the European Communities. Article 22 1. Contracting entities shall make known, at least once a year, by means of a periodic indicative notice: (a) in the case of supply contracts, the total of the contracts for each product area of which the estimated value, taking into account the provisions of Article 14, is equal to or greater than ECU 750 000, and which they intend to award over the following twelve months; (b) in the case of works contracts, the essential characteristics of the works contracts which the contracting entities intend to award, the estimated value of which is not less than the threshold laid down in Article 14 (1). (c) in the case of service contracts, the estimated total value of the service contracts in each of the categories of services listed in Annex XVI A which they intend to award over the following 12 months, where such estimated total value, taking into account the provisions of Article 14, is equal to or greater than ECU 750 000. 2. The notice shall be drawn up in accordance with Annex XIV and published in the Official Journal of the European Communities. 3. Where the notice is used as a means of calling for competition in accordance with Article 21 (1) (b), it must have been published not more than 12 months prior to the date on which the invitation referred to in Article 21 (2) (c) is sent. Moreover, the contracting entity shall meet the deadlines laid down in Article 26 (2). 4. Contracting entities may, in particular, publish periodic indicative notices relating to major projects without repeating information previously included in a periodic indicative notice, provided that it is clearly stated that such notices are additional notices. Article 23 1. This Article shall apply to design contests organized as part of a procedure leading to the award of a service contract the estimated value net of VAT for which is not less than the value referred to in Article 14 (1). 2. This Article shall apply to all design contests where the total amount of contest prizes and payments to participants is not less than ECU 400 000 for design contests organized by entities exercising an activity referred to in Article 2 (2) (a), (b) and (c) and ECU 600 000 for design contests organized by entities exercising an activity referred to in Article 2 (2) (d). 3. The rules for the organization of a design contest shall be in conformity with the requirements of this Article and shall be communicated to those interested in participating in the contest. 4. The admission of participants to design contests shall not be limited: - by reference to the territory or part of the territory of a Member State, - on the grounds that, under the law of the Member State in which the contest is organized, they would have been required to be either natural or legal persons. 5. Where design contests are restricted to a limited number of participants, the contracting authorities shall lay down clear and non-discriminatory selection criteria. In any event, the number of candidates invited to participate shall be sufficient to ensure genuine competition. 6. The jury shall be composed exclusively of natural persons who are independent of participants in the contest. Where a particular professional qualification is required from participants in a contest, at least a third of its members must have the same qualification or its equivalent. The jury shall be autonomous in its decisions or opinions. These shall be reached on the basis of projects submitted anonymously and solely on the grounds of the criteria indicated in the notice provided for in Annex XVII. Article 24 1. Contracting entities which have awarded a contract or organized a design contest shall communicate to the Commission, within two months of the award of the contract and under conditions to be laid down by the Commission in accordance with the procedure laid down in Article 40, the results of the awarding procedure by means of a notice drawn up in accordance with Annex XV or Annex XVIII. 2. Information provided under Section I of Annex XV or under Annex XVIII shall be published in the Official Journal of the European Communities. In this connection the Commission shall respect any sensitive commercial aspects which the contracting entities may point out when forwarding this information in connection with points 6 and 9 of Annex XV. 3. Contracting entities awarding service contracts within category No 8 of Annex XVI A to which Article 20 (2) (b) applies need mention, concerning point 3 of Annex XV, only the main title thereof within the meaning of the classification of Annex XVI. Contracting entities awarding service contracts within category No 8 of Annex XVI A to which Article 20 (2) (b) does not apply may, on the grounds of commercial confidentiality, limit the information provided for in point 3 of Annex XV. However, they must ensure that any information published under this point is no less detailed than that contained in the notice of the call for competition published in accordance with Article 20 (1) or, where a qualification system is used, no less detailed than the category referred to in Article 30 (7). In the case listed in Annex XVI B, the contracting entites shall indicate in the notice whether they agree on its publication. 4. Information provided under Section II of Annex XV must not be published, except in aggregated form, for statistical purposes. Article 25 1. The contracting entities must be able to supply proof of the date of dispatch of the notices referred to in Articles 20 to 24. 2. The notices shall be published in full in their original language in the Official Journal of the European Communities and in the TED data bank. A summary of the important elements of each notice shall be published in the other official languages of the Community, the original text alone being authentic. 3. The Office for Official Publications of the European Communities shall publish the notices not later than 12 days after their dispatch. In exceptional cases it shall endeavour to publish the notice referred to in Article 21 (1) (a) within five days in response to a request by the contracting entity and provided that the notice has been sent to the Office by electronic mail, telex or telefax. Each edition of the Official Journal of the European Communities which contains one or more notices shall reproduce the model notice or notices on which the published notice or notices is/are based. 4. The cost of publication of the notices in the Official Journal of the European Communities shall be borne by the Communities. 5. Contracts or design contests in respect of which a notice is published in the Official Journal of the European Communities pursuant to Article 21 (1) or (4) shall not be published in any other way before that notice has been dispatched to the Office for Official Publications of the European Communities. Such publication shall not contain information other than that published in the Official Journal of the European Communities. Article 26 1. In open procedures the time limit for the receipt of tenders shall be fixed by contracting entities at not less than 52 days from the date of dispatch of the notice. This time limit may be shortened to 36 days where contracting entities have published a notice in accordance with Article 22 (1). 2. In restricted procedures and in negotiated procedures with a prior call for competition, the following arrangements shall apply: (a) the time limit for receipt of requests to participate, in response to a notice published in accordance with Article 21 (1) (a) or in response to an invitation from a contracting entity in accordance with Artice 21 (2) (c), shall, as a general rule, be at least five weeks from the date of dispatch of the notice or invitation and shall in any case not be less than the time limit for publication laid down in Article 25 (3), plus 10 days; (b) the time limit for receipt of tenders may be fixed by mutual agreement between the contracting entity and the selected candidates, provided that all tenderers are given equal time to prepare and submit tenders; (c) where it is not possible to reach agreement on the time limit for the receipt of tenders, the contracting entity shall fix a time limit which shall, as a general rule, be at least three weeks and shall in any case not be less than 10 days from the date of the invitation to tender; the time allowed shall be sufficiently long to take account in particular of the factors mentioned in Article 28 (3). Article 27 In the contract documents, the contracting entity may ask the tenderer to indicate in his tender any share of the contract which he may intend to subcontract to third parties. This indication shall be without prejudice to the question of the principal contractor's responsibility. Article 28 1. Provided that they have been requested in good time, the contract documents and supporting documents must be sent to the suppliers, contractors or service providers by the contracting entities as a general rule within six days of receipt of the application. 2. Provided that it has been requested in good time, additional information relating to the contract documents shall be supplied by the contracting entities not later than six days before the final date fixed for receipt of tenders. 3. Where tenders require the examination of voluminous documentation such as lengthy technical specifications, a visit to the site or an on-the-spot inspection of the documents supporting the contract documents, this shall be taken into account when the appropriate time limits are fixed. 4. Contracting entities shall invite the selected candidates simultaneously and in writing. The letter of invitation shall be accompanied by the contract documents and supporting documents. It shall include at least the following information: (a) the address from which any additional documents can be requested, the final date for such requests and the amount and methods of payment of any sum to be paid for such documents; (b) the final date for receipt of tenders, the address to which they must be sent and the language or languages in which they must be drawn up; (c) a reference to any tender notice published; (d) an indication of any document to be annexed; (e) the criteria for the award of the contract if these are not given in the notice; (f) any other special condition for participation in the contract. 5. Requests for participation in contracts and invitations to tender must be made by the most rapid means of communication possible. When requests to participate are made by telegram, telex, telephone or any electronic means, they must be confirmed by letter dispatched before the expiry of the time limit referred to in Article 26 (1) or of the time limit set by contracting entities pursuant to Article 26 (2). Article 29 1. The contracting entity may state in the contract documents, or be obliged by a Member State so to do, the authority or authorities from which a tenderer may obtain the appropriate information on the obligations relating to the employment protection provisions and the working conditions which are in force in the Member State, region or locality in which the works or services are to be executed or performed and which shall be applicable to the works carried out or the services performed on site during the performance of the contract. 2. A contracting entity which supplies the information referred to in paragraph 1 shall request the tenderers or those participating in the contract procedure to indicate that they have taken account, when drawing up their tender, of the obligations relating to employment protection provisions and the working conditions which are in force in the place where the work or the service is to be carried out or performed. This shall be without prejudice to the application of Article 34 (5) concerning the examination of abnormally low tenders. TITLE V Qualification, selection and award Article 30 1. Contracting entities which so wish may establish and operate a system of qualification of suppliers, contractors or service providers. 2. The system, which may involve different qualification stages, shall operate on the basis of objective criteria and rules to be established by the contracting entity. The contracting entity shall use European standards as a reference where they are appropriate. The criteria and rules may be updated as required. 3. The criteria and rules for qualification shall be made available on request to interested suppliers, contractors or service providers. The updating of these criteria and rules shall be communicated to the interested suppliers, contractors and service providers. Where a contracting entity considers that the qualification system of certain third entities or bodies meets its requirements, it shall communicate to interested suppliers, contractors and service providers the names of such third entities or bodies. 4. Contracting entities shall inform applicants of their decision as to qualification within a reasonable period. If the decision will take longer than six months from the presentation of an application, the contracting entity shall inform the applicant, within two months of the application, of the reasons justifying a longer period and of the date by which its application will be accepted or refused. 5. In reaching their decision as to qualification or when the criteria and rules are being updated, contracting entities may not: - impose conditions of an administrative, technical or financial nature on some suppliers, contractors or service providers which are not imposed on others, - require tests or proof which duplicate objective evidence already available. 6. Applicants whose qualification is refused shall be informed of this decision and the reasons for refusal. The reasons must be based on the criteria for qualification referred to in paragraph 2. 7. A written record of qualified suppliers, contractors or service providers shall be kept and it may be divided into categories, according to the type of contract for which the qualification is valid. 8. Contracting entities may bring the qualification of a supplier, contractor or service provider to an end only for reasons based on the criteria referred to in paragraph 2. The intention to bring qualification to an end must be notified in writing to the supplier, contractor or service provider beforehand, together with the reason or reasons justifying the proposed action. 9. The qualification system shall be the subject of a notice drawn up in accordance with Annex XIII and published in the Official Journal of the European Communities, indicating the purpose of the qualification system and the availability of the rules concerning its operation. Where the system is of a duration greater than three years, the notice shall be published annually. Where the system is of a shorter duration, an initial notice shall suffice. Article 31 1. Contracting entities which select candidates to tender in restricted procedures or to participate in negotiated procedures shall do so according to objective criteria and rules which they lay down and which they shall make available to interested suppliers, contractors or service providers. 2. The criteria used may include the criteria for exclusion specified in Article 23 of Directive 71/305/EEC and in Article 20 of Directive 77/62/EEC. 3. The criteria may be based on the objective need of the contracting entity to reduce the number of candidates to a level which is justified by the need to balance the particular characteristics of the contract award procedure and the resources required to complete it. The number of candidates selected must, however, take account of the need to ensure adequate competition. Article 32 Should contracting entities require the production of certificates drawn up by independent bodies for attesting conformity of the service provider to certain quality assurance standards, they shall refer to quality assurance systems based on the relevant EN 29 000 European standards series certified by bodies conforming to the EN 45 000 European standards series. Entities shall recognize equivalent certificates from bodies established in other Member States. They shall also accept other evidence of equivalent quality assurance measures from service providers who have no access to such certificates or no possibility of obtaining them within the relevant time limits. Article 33 1. Groupings of suppliers, contractors or service providers shall be permitted to tender or negotiate. The conversion of such groupings into a specific legal form shall not be required in order to submit a tender or to negotiate, but the grouping selected may be required so to convert itself once it has been awarded the contract where such conversion is necessary for the proper performance of the contract. 2. Candidates or tenderers who, under the law of the Member State in which they are established, are entitled to carry out the relevant service activity shall not be rejected on the sole ground that under the law of the Member State in which the contract is awarded they would have been required to be either a natural or a legal person. 3. However, legal persons may be required to indicate, in the tender or the request for participation, the names and relevant professional qualifications of the staff to be responsible for the performance of the service. Article 34 1. Without prejudice to national laws, regulations or administrative provisions on the remuneration of certain services, the criteria on which the contracting entities shall base the award of contracts shall be: (a) the most economically advantageous tender, involving various criteria depending on the contract in question, such as: delivery or completion date, running costs, cost-effectiveness, quality, aesthetic and functional characteristics, technical merit, after-sales service and technical assistance, commitments with regard to spare parts, security of supplies and price; or (b) the lowest price only. 2. In the case referred to in paragraph 1 (a), contracting entities shall state in the contract documents or in the tender notice all the criteria which they intend to apply to the award, where possible in descending order of importance. 3. Where the criterion for the award of the contract is that of the most economically advantageous tender, contracting entities may take account of variants which are submitted by a tenderer and meet the minimum specifications required by the contracting entities. Contracting entities shall state in the contract documents the minimum specifications to be respected by the variants and specific requirements for their presentation. Where variants are not permitted, they shall so indicate in the contract documents. 4. Contracting entities may not reject the presentation of a variant on the sole ground that it was drawn up on the basis of technical specifications defined with reference to European specifications or to national technical specifications recognized as complying with the essential requirements within the meaning of Directive 89/106/EEC. 5. If, for a given contract, tenders appear abnormally low in relation to the provision of services, the contracting entity shall, before it may reject those tenders, request in writing details of the constituent elements of the tender which it considers relevant and shall verify those constituent elements taking account of the explanations received. It may set a reasonable period within which to reply. The contracting entity may take into consideration explanations which are justified on objective grounds relating to the economy of the construction or production method, or the technical solutions chosen, or the exceptionally favourable conditions available to the tenderer for the execution of the contract, or the originality of the product or the work proposed by the tenderer. Contracting entities may reject tenders which are abnormally low owing to the receipt of State aid only if they have consulted the tenderer and if the tenderer has been unable to show that the aid in question has been notified to the Commission pursuant to Article 93 (3) of the EEC Treaty or has received the Commission's approval. Contracting entities which reject a tender under these circumstances shall inform the Commission thereof. Article 35 1. Article 27 (1) shall not apply where a Member State bases the award of contracts on other criteria, within the framework of rules in force at the time of adoption of this Directive, the aim of which is to give preference to certain tenderers, provided that the rules invoked are compatible with the Treaty. 2. Without prejudice to paragraph 1, this Directive shall not prevent, until 31 December 1992, the application of national provisions in force on the award of supply or works contracts which have as their objective the reduction of regional disparities and the promotion of job creation in disadvantaged regions or those suffering from industrial decline, provided that the provisions concerned are compatible with the EEC Treaty and with the Community's international obligations. Article 36 1. This Article shall apply to tenders comprising products originating in third countries with which the Community has not concluded, multilaterally or bilaterally, an agreement ensuring comparable and effective access for Community undertakings to the markets of those third countries. It shall be without prejudice to the obligations of the Community or its Member States in respect of third countries. 2. Any tender made for the award of a supply contract may be rejected where the proportion of the products originating in third countries, as determined in accordance with Council Regulation (EEC) No 802/68 of 27 June 1968 on the common definition of the concept of the origin of goods (16) , exceeds 50 % of the total value of the products constituting the tender. For the purposes of this Article, software used in telecommunications network equipment shall be considered as products. 3. Subject to paragraph 4, where two or more tenders are equivalent in the light of the award criteria defined in Article 34, preference shall be given to the tenders which may not be rejected pursuant to paragraph 2. The prices of these tenders shall be considered equivalent for the purposes of this Article, if the price difference does not exceed 3 %. 4. However, a tender shall not be preferred to another pursuant to paragraph 3 where its acceptance would oblige the contracting entity to acquire material having technical characteristics different from those of existing material, resulting in incompatibility or technical difficulties in operation and maintenance or disproportionate costs. 5. For the purpose of this Article, those third countries to which the benefit of the provisions of this Directive has been extended by a Council Decision in accordance with paragraph 1 shall not be taken into account for determining the proportion referred to in paragraph 2 of products originating in third countries. 6. The Commission shall submit an annual report to the Council (for the first time in the second half of 1991) on progress made in multilateral or bilateral negotiations regarding access for Community undertakings to the markets of third countries in the fields covered by this Directive, on any result which such negotiations may have achieved and on the implementation in practice of all the agreements which have been concluded. The Council, acting by a qualified majority on a proposal from the Commission, may amend the provisions of this Article in the light of such developments. Article 37 1. The Member States shall inform the Commission of any general difficulties encountered, in law or in fact, by their undertakings in securing the award of service contracts in third countries. 2. The Commission shall report to the Council before 31 December 1994 and periodically thereafter on the opening-up of service contracts in third countries and on progress in negotiations with these countries on this subject, particularly within the GATT framework. 3. Whenever the Commission establishes, on the basis of either the reports referred to in paragraph 2 or other information, that with regard to the award of service contracts a third country: (a) does not grant Community undertakings effective access comparable to that granted by the Community to undertakings from that country; (b) does not grant Community undertakings national treatment or the same competitive opportunities as are available to national undertakings; or (c) grants undertakings from other third countries more favourable treatment than Community undertakings, it must approach the third country concerned to try to remedy the situation. 4. Under the conditions referred to in paragraph 3, the Commission may at any time propose that the Council decide to suspend or restrict the award of service contracts to: (a) undertakings governed by the law of the third country in question; (b) undertakings affiliated to the undertakings specified in (a) and having their registered office in the Community but having no direct and effective link with the economy of a Member State; (c) undertakings submitting tenders which have as their object services originating in the third country in question, during a period to be determined in the decision. The Council shall act by qualified majority as soon as possible. The Commission may propose these measures on its own initiative or at the request of a Member State. 5. This Article is without prejudice to the obligations of the Community in relation to third countries. TITLE VI Final provisions Article 38 1. The value in national currencies of the thresholds specified in Article 14 shall, in principle, be revised every two years with effect from the date provided for in Directive 77/62/EEC as far as the thresholds for supply and service contracts are concerned and from the date provided for in Directive 71/305/EEC as far as the thresholds for works contracts are concerned. The calculation of such value shall be based on the average daily values of those currencies expressed in ecus over the 24 months terminating on the last day of August preceding the revision with effect from 1 January. The values shall be published in the Official Journal of the European Communities at the beginning of November. 2. The method of calculation laid down in paragraph 1 shall be examined pursuant to the provisions of Directive 77/62/EEC. Article 39 1. The Commission shall be assisted, as regards procurement by the contracting entities exercising an activity referred to in Article 2 (2) (d), by a Committee of an advisory nature which shall be the Advisory Committee on Telecommunications Procurement. The Committee shall be composed of representatives of the Member States and chaired by a representative of the Commission. 2. The Commission shall consult this Committee on: (a) amendments to Annex X; (b) revision of the currency values of the thresholds; (c) the rules concerning contracts awarded under international agreements; (d) the review of the application of this Directive; (e) the procedures described in Article 40 (2) relating to notices and statistical reports. Article 40 1. Annexes I to X shall be revised in accordance with the procedure laid down in paragraphs 4 to 8 with a view to ensuring that they fulfil the criteria of Article 2. 2. The conditions for the presentation, dispatch, reception, translation, keeping and distribution of the notices referred to in Articles 21, 22 and 24 and of the statistical reports provided for in Article 42 shall be established, for the purposes of simplification, in accordance with the procedure laid down in paragraphs 4 to 8. 3. The nomenclature cited in Annexes XVI A and XVI B and the references in the notices to particular headings of the nomenclature may be amended in accordance with the procedure laid down in paragraphs 4 to 8. 4. The revised Annexes and the conditions referred to in paragraphs 1 and 2 shall be published in the Official Journal of the European Communities. 5. The Commission shall be assisted by the Advisory Committee for Public Contracts and, in the case of the revision of Annex X, by the Advisory Committee on Telecommunications Procurement provided for in Article 39 of this Directive. 6. The Commission representative shall submit to the Committee a draft of the decisions 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. 7. The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes. 8. 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 41 1. Contracting entities shall keep appropriate information on each contract which shall be sufficient to permit them at a later date to justify decisions taken in connection with: (a) the qualification and selection of contractors, suppliers or service providers and award of contracts; (b) recourse to derogations from the use of European specifications in accordance with Article 18 (6); (c) use of procedures without prior call for competition in accordance with Article 21 (2); (d) non-application of Titles II, III and IV in accordance with the derogations provided for in Title I. 2. The information shall be kept for at least four years from the date of award of the contract so that the contracting entity will be able, during that period, to provide the necessary information to the Commission if the latter so requests. Article 42 1. The Member States shall ensure, in accordance with the arrangements to be laid down under the procedure provided for in Article 40 (4) to (8), that the Commission receives each year a statistical report concerning the total value, broken down by Member State and each category of activity to which Annexes I to X refer, of the contracts awarded below the thresholds defined in Article 14 which would, if they were not below those thresholds, be covered by this Directive. 2. Arrangements shall be fixed in accordance with the procedure referred to in Article 40 to ensure that: (a) in the interests of administrative simplification, contracts of lesser value may be excluded, provided that the usefulness of the statistics is not jeopardized; (b) the confidential nature of the information provided is respected. Article 43 Article 2 (2) of Directive 77/62/EEC is hereby replaced by the following: '2. This Directive shall not apply to: (a) contracts awarded in the fields referred to in Articles 2, 7, 8 and 9 of Council Directive 90/531/EEC of 17 September 1990 on the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors (1) or fulfilling the conditions in Article 6 (2) of the said Directive; (b) supplies which are declared secret or when their delivery must be accompanied by special security measures in accordance with the laws, regulations or administrative provisions in force in the Member State concerned or when the protection of the basic interests of that State's security so requires (1). (1) OJ No L 297, 29. 10. 1990, p. 1.' Article 44 Not later than four years after the application of this Directive, the Commission, acting in close cooperation with the Advisory Committee for Public Contracts, shall review the manner in which this Directive has operated and its field of application and, if necessary, shall make further proposals to adapt it, in the light of developments linked in particular with progress made in opening up contracts and the level of competition. In the case of entities exercising an activity defined in Article 2 (2) (d), the Commission shall act in close cooperation with the Advisory Committee on Telecommunications Procurement. Article 45 1. Member States shall adopt the measures necessary to comply with the provisions of this Directive and shall apply them by 1 July 1994. They shall forthwith inform the Commission thereof. 2. Nevertheless, the Kingdom of Spain may provide that the measures referred to in paragraph 1 shall apply from 1 January 1997 only and the Hellenic Republic and the Portuguese Republic may provide that the measures referred to in paragraph 1 shall apply from 1 January 1998 only. 3. Directive 90/531/EEC shall cease to have effect as from the date on which this Directive is applied by the Member States and this shall be without prejudice to the obligations of the Member States concerning the deadlines laid down in Article 37 of that Directive. 4. References to Directive 90/531/EEC shall be construed as referring to this Directive. Article 46 When Member States adopt the provisions referred to in Article 45, they shall contain a reference to this Directive or 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. Article 47 Member States shall communicate to the Commission the main provisions of national law, whether laws, regulations or administrative provisions, which they adopt in the field covered by this Directive. Article 48 This Directive is addressed to the Member States.

31993L0035

1993

Council Directive 93/35/EEC of 14 June 1993 amending for the sixth time Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products 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 the legal ambiguities in Directive 76/768/EEC (4) particularly in Articles 1 and 2, should be removed; Whereas it has become apparent that it is desirable that data on the ingredients employed in cosmetic products be gathered so that all issues relating to their use and the resulting action at Community level may be assessed with a view, in particular, to the establishment of a common nomenclature of ingredients used in cosmetic products; whereas the gathering of that data can be facilitated if the Commission compiles an inventory of the ingredients concerned; whereas that inventory will be indicative and is not intended to constitute a limitative list of substances used in cosmetic products; Whereas greater transparency is needed regarding the ingredients employed in cosmetics if the latter are to be placed on the market without any prior procedure, if the necessary information on the finished product is to be available solely at the place of manufacture or of initial importation into the Community and if better information is to be provided to the consumer; whereas such transparency should be achieved by indication of a product's function and of the ingredients used in a cosmetic product on its packaging; whereas where for practical reasons it is impossible to indicate the ingredients and any warnings regarding use on the container or the packaging, such particulars should be enclosed so that the consumer may have access to all necessary information; Whereas, with regard to the finished cosmetic product, it should be made clear which information is to be made available to the monitoring authorities of the place of manufacture or of initial importation into the Community market; whereas that information should include all the necessary particulars relating to identity, quality, safety for human health and the effects claimed for the cosmetic product; Whereas, however, for reasons of monitoring, the competent authority should be apprised of the place of manufacture and of the information needed for rapid and appropriate medical treatment in the event of difficulties; Whereas the Commission should be authorized to amend Annexes I and VIII to Directive 76/768/EEC in view of their illustrative and technical nature; Whereas assessment of the safety of use of the ingredients employed in cosmetics and of the final product should take account of the requirements of Directive 86/609/EEC (5), which concerns the protection of animals used for experimental and other scientific purposes, and in particular Article 7 (2) thereof; Whereas testing on animals of ingredients or combinations of ingredients should be banned as from 1 January 1998; whereas, however, that date should be postponed where alternative methods of testing have not been scientifically validated; whereas the Commission should submit a report on progress made with regard to such methods, Article 1 Directive 76/768/EEC is hereby amended as follows: 1. Article 1 (1) shall be replaced by the following: '1. A "cosmetic product" shall mean any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.'; 2. Article 2 shall be replaced by the following: 'Article 2 A cosmetic product put on the market within the Community must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use, taking account, in particular, of the product's presentation, its labelling, any instructions for its use and disposal as well as any other indication or information provided by the manufacturer or his authorized agent or by any other person responsible for placing the product on the Community market. The provision of such warnings shall not, in any event, exempt any person from compliance with the other requirements laid down in this Directive.'; 3. the following subparagraph shall be added to Article 4 (1): '(i) ingredients or combinations of ingredients tested on animals after 1 January 1998 in order to meet the requirements of this Directive. If there has been insufficient progress in developing satisfactory methods to replace animal testing, and in particular in those cases where alternative methods of testing, despite all reasonable endeavours, have not been scientifically validated as offering an equivalent level of protection for the consumer, taking into account OECD toxicity test guidelines, the Commission shall, by 1 January 1997, submit draft measures to postpone the date of implementation of this provision, for a sufficient period, and in any case for no less than two years, in accordance with the procedure laid down in Article 10. Before submitting such measures, the Commission will consult the Scientific Committee on Cosmetology. The Commission shall present an annual report to the European Parliament and the Council on progress in the development, validation and legal acceptance of alternative methods to those involving experiments on animals. That report shall contain precise data on the number and type of experiments relating to cosmetic products carried out on animals. The Member States shall be obliged to collect that information in addition to collecting statistics as laid down by Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes. The Commission shall in particular ensure the development, validation and legal acceptance of experimental methods which do not use live animals.'; 4. the following Article shall be inserted: 'Article 5a 1. No later than 14 December 1994 the Commission shall, under the procedure laid down in Article 10, compile an inventory of ingredients employed in cosmetic products, on the basis in particular of information supplied by the industry concerned. For the purposes of this Article, "cosmetic ingredient" shall mean any chemical substance or preparation of synthetic or natural origin, except for perfume and aromatic compositions, used in the composition of cosmetic products. The inventory shall be divided into two sections: one concerning perfume and aromatic raw materials and the second concerning other substances. 2. The inventory shall contain informtion on: - the identity of each ingredient, in particular its chemical name, the CTFA name, the European Pharmacopoeia name, the international non-proprietary names recommended by the World Health Organization, the Einecs, Iupac, CAS and colour index numbers, and the common name referred to in Article 7 (2), - the usual function(s) of the ingredient in the final product, - where appropriate, restrictions and conditions of use and warnings which must be printed on the label by reference to the Annexes. 3. The Commission shall publish the inventory and shall update it periodically under the procedure provided for in Article 10. The inventory shall be indicative and shall not constitute a list of the substances authorized for use in cosmetic products.'; 5. in Article 6 (1), the introductory sentence shall be replaced by the following: '1. Member States shall take all measures necessary to ensure that cosmetic products may be marketed only if the container and packaging bear the following information in indelible, easily legible and visible lettering; the information mentioned in point (g) may, however, be indicated on the packaging alone:'; 6. Article 6 (1) (d) shall be replaced by the following: '(d) particular precautions to be observed in use, especially those listed in the column "Conditions of use and warnings which must be printed on the label" in Annexes III, IV, VI and VII, which must appear on the container and packaging, as well as any special precautionary information on cosmetic products for professional use, in particular in hairdressing. Where this is impossible for practical reasons, an enclosed leaflet, label, tape or card must contain that information to which the consumer is referred either by abbreviated information or the symbol given in Annex VIII, which must appear on the container and the packaging.'; 7. the following subparagraphs (f) and (g) shall be added to Article 6 (1): '(f) the function of the product, unless it is clear from the presentation of the product; (g) a list of ingredients in descending order of weight at the time they are added. That list shall be preceded by the word "ingredients". Where that is impossible for practical reasons, an enclosed leaflet, label, tape or card must contain the ingredients to which the consumer is referred either by abbreviated information or the symbol given in Annex VIII, which must appear on the container and the packaging. The following shall not, however, be regarded as ingredients: - impurities in the raw materials used, - subsidiary technical materials used in the preparation but not present in the final product, - materials used in strictly necessary quantities as solvents or as carriers for perfume and aromatic compositions. Perfume and aromatic compositions and their raw materials shall be referred to by the word "perfume" or "flavour". Ingredients in concentrations of less than 1 % may be listed in any order after those in concentrations of more than 1 %. Colouring agents may be listed in any order after the other ingredients, in accordance with the colour index number or denomination adopted in Annex IV. For decorative cosmetic products marketed in several colour shades, all colouring agents used in the range may be listed, provided that the terms "may contain" are added. An ingredient must be identified by the common name referred to in Article 7 (2) or, failing that, by one of the names referred to in Article 5a (2), first indent. In accordance with the procedure laid down in Article 10, the Commission shall, no later than 14 December 1994, adopt the criteria and conditions under which a manufacturer may, for reasons of trade secrecy, apply not to include one or more ingredients on the abovementioned list.'; 8. the following two paragraphs shall be added at the end of Article 6 (1): 'Where it is impracticable, for reasons of size or shape, for the particulars referred to in points (d) and (g) to appear in an enclosed leaflet, those particulars shall appear on a label, tape or card which is enclosed or attached to the cosmetic product. In the case of soap, bath balls and other small products where it is impraticable, for reasons of size or shape, for the particulars referred to in point (g) to appear on a label, tag, tape or card or in an enclosed leaflet, those particulars shall appear on a notice in immediate proximity to the container in which the cosmetic product is exposed for sale.'; 9. the following shall be added at the end of Article 6 (3): 'Furthermore, any reference to testing on animals must state clearly whether the tests carried out involved the finished product and/or its ingredients.'; 10. Article 7 (2) shall be replaced by the following: '2. They may, however, require that the particulars provided for in Article 6 (1) (b), (c), (d) and (f) be expressed at least in their own national or official language or languages; they may also require that the particulars provided for in Article 6 (1) (g) be expressed in a language easily understood by the consumer. To that end, the Commission shall adopt a common ingredients nomenclature in accordance with the Article 10 procedure.'; 11. Article 7 (3) shall be replaced by the following: '3. Furthermore, a Member State may, for purposes of prompt and appropriate medical treatment in the event of difficulties, require that appropriate and adequate information on substances used in cosmetic products be made available to the competent authority, which shall ensure that that information is used only for the purposes of such treatment. Each Member State shall designate a competent authority and send details thereof to the Commission, which shall publish that information in the Official Journal of the European Communities.'; 12. the following following Article shall be inserted: 'Article 7a 1. The manufacturer or his agent or the person to whose order a cosmetic product is manufactured or the person responsible for placing an imported cosmetic product on the Community market shall for control purposes keep the following information readily accessible to the competent authorities of the Member State concerned at the address specified on the label in accordance with Article 6 (1) (a): (a) the qualitative and quantitative composition of the product; in the case of perfume compositions and perfumes, the name and code number of the composition and the identity of the supplier; (b) the physico-chemical and microbiological specifications of the raw materials and the finished product and the purity and microbiological control criteria of the cosmetic product; (c) the method of manufacture complying with the good manufacturing practice laid down by Community law or, failing that, laid down by the law of the Member State concerned; the person responsible for manufacture or first importation into the Community must possess an appropriate level of professional qualification or experience in accordance with the legislation and practice of the Member State which is the place of manufacture or first importation; (d) assessment of the safety for human health of the finished product. To that end the manufacturer shall take into consideration the general toxicological profile of the ingredient, its chemical structure and its level of exposure. Should the same product be manufactured at several places within Community territory, the manufacturer may choose a single place of manufacture where that information will be kept available. In this connection, and when so requested for monitoring purposes, he shall be obliged to indicate the place so chosen to the monitoring authority/authorities concerned; (e) the name and address of the qualified person or persons responsible for the assessment referred to in (d). That person must hold a diploma as defined in Article 1 of Directive 89/48/EEC in the field of pharmacy, toxicology, dermatology, medicine or a similar discipline; (f) existing data on undesirable effects on human health resulting from use of the cosmetic product; (g) proof of the effect claimed for the cosmetic product, where justified by the nature of the effect or product. 2. The assessment of the safety for human health referred to in paragraph 1 (d) shall be carried out in accordance with the principle of good laboratory practice laid down in Council Directive 87/18/EEC of 18 December 1986 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances (*). 3. The information referred to in paragraph 1 must be available in the national language or languages of the Member State concerned, or in a language readily understood by the competent authorities. 4. The manufacturer or his agent, or the person to whose order a cosmetic product is manufactured, or the person responsible for placing imported cosmetic products on the Community market, shall notify the competent authority of the Member State of the place of manufacture or of the initial importation of the address of the place of manufacture or of initial importation into the Community of the cosmetic products before the latter are placed on the Community market. 5. Member States shall designate the competent authorities referred to in paragraphs 1 and 4 and shall send details thereof to the Commission, which shall publish that information in the Official Journal of the European Communities. The Member States shall ensure that the abovementioned authorities continue to cooperate in areas where such cooperation is necessary to the smooth application of this Directive. (*) OJ No L 15, 17. 1. 1987, p. 29.'; 13. Article 8 (2) shall be replaced by the following: '2. The common nomenclature of ingredients used in cosmetic products and, after consultation of the Scientific Committee on Cosmetology, the amendments necessary for the adaptation to technical progress of the Annexes shall be adopted in accordance with the same procedure, as appropriate.'; 14. Annex VIII appearing in the Annex to this Directive shall be added. Article 2 1. Member States shall take all necessary measures to ensure that from 1 January 1997 neither manufacturers nor importers established within the Community place on the market cosmetic products which fail to comply with this Directive. 2. Member States shall take all measures necessary to ensure that the products referred to in paragraph 1 cannot be sold or disposed of to the ultimate consumer after 31 December 1997. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive no later than 14 June 1995. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time 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 texts of the provisions of domestic law which they adopt in the field governed by this Directive. Article 4 This Directive is addressed to the Member States.

31993L0030

1993

COUNCIL DIRECTIVE 93/30/EEC of 14 June 1993 on audible warning devices for two- or three-wheel motor vehicles Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof, Having regard to Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two- or three-wheel motor vehicles (1), Having regard to the proposal from the Commission (2), In cooperation with the European Parliament (3), Having regard to the opinion of the Economic and Social Committee (4), Whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; whereas the measures required for that purpose need to be adopted; Whereas, with regard to audible warning devices, in each Member State two- or three-wheel motor vehicles must display certain technical characteristics laid down by mandatory provisions which differ from one Member State to another; whereas as a result of their differences, such provisions constitute a barrier to trade within the Community; Whereas these obstacles to the operation of the internal market may be removed if the same requirements are adopted by all Member States in place of their national rules; Whereas it is necessary to draw up harmonized requirements concerning audible warning devices for two-or three-wheel motor vehicles in order to enable the type-approval and component type-approval procedures laid down in Directive 92/61/EEC to be applied for each type of such vehicle. Whereas, given the scale and impact of the action proposed in the sector in question, the Community measures covered by this Directive are necessary, indeed essential, to achieve the aim in view, which is to establish Community vehicle type-approval; whereas that aim cannot be adequately achieved by the Member States individually; Whereas in order to facilitate access to the markets of non-Community countries it would seem necessary to establish equivalence between the requirements of this Directive and those of Regulation No 28 of the United Nations Economic Commission for Europe, Article 1 This Directive applies to audible warning devices for all types of vehicle as defined in Article 1 of Directive 92/61/EEC. Article 2 The procedures for the granting of component type-approval in respect of audible warning devices for a type of two- or three-wheel motor vehicle, the component type-approval of an audible warning device in the form of a component and the conditions governing the free movement of such vehicles and the unimpeded placing on the market of audible warning devices shall be as laid down in Chapters II and III of Directive 92/61/EEC. Article 3 In accordance with the provisions of Article 11 of Directive 92/61/EEC, equivalence between the requirements laid down in this Directive and those laid down in UN/ECE Regulation No 28 (E/ECEATRANS/505 — Rev. 1 /Add. 27) is hereby acknowledged. The authorities of the Member States which grant component type-approval shall accept approvals granted in accordance with the requirements of the abovementioned Regulation No 28 as well as component type-approval marks as an alternative to the corresponding approvals granted in accordance with the requirements of this Directive. Article 4 This Directive may be amended in accordance with Article 13 of Directive 70/156/EEC (5) in order to: — take into account any amendments to the ECE Regulation referred to in Article 3, — adapt the Annex to technical progress. Article 5 1. Member States shall adopt and publish the provisions necessary to comply with this Directive not later than 14 December 1994. They shall forthwith inform the Commission thereof. When the Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. From the date mentioned in the first subparagraph Member States may not, for reasons connected with audible warning devices, prohibit the initial entry into service of vehicles which conform to this Directive. They shall apply the provisions referred to in the first subparagraph as from 14 June 1995. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the covered by this Directive. Article 6 This Directive is adressed to the Member States.

31993L0042

1993

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices 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 measures should be adopted in the context of the internal market; whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas the content and scope of the laws, regulations and administrative provisions in force in the Member States with regard to the safety, health protection and performance characteristics of medical devices are different; whereas the certification and inspection procedures for such devices differ from one Member State to another; whereas such disparities constitute barriers to trade within the Community; Whereas the national provisions for the safety and health protection of patients, users and, where appropriate, other persons, with regard to the use of medical devices should be harmonized in order to guarantee the free movement of such devices within the internal market; Whereas the harmonized provisions must be distinguished from the measures adopted by the Member States to manage the funding of public health and sickness insurance schemes relating directly or indirectly to such devices; whereas, therefore, the provisions do not affect the ability of the Member States to implement the abovementioned measures provided Community law is complied with; Whereas 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 certain medical devices are intended to administer medicinal products within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (4); whereas, in such cases, the placing on the market of the medical device as a general rule is governed by the present Directive and the placing on the market of the medicinal product is governed by Directive 65/65/EEC; whereas if, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral unit which is intended exclusively for use in the given combination and which is not reusable, that single-unit product shall be governed by Directive 65/65/EEC; whereas a distinction must be drawn between the abovementioned devices and medical devices incorporating, inter alia, substances which, if used separately, may be considered to be a medicinal substance within the meaning of Directive 65/65/EEC; whereas in such cases, if the substances incorporated in the medical devices are liable to act upon the body with action ancillary to that of the device, the placing of the devices on the market is governed by this Directive; whereas, in this context, the safety, quality and usefulness of the substances must be verified by analogy with the appropriate methods specified in Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (5); Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any reference to 'minimizing' or 'reducing' risk must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical 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 (6), rules regarding the design and manufacture of medical devices 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 should be applied with discretion to take account of the technological level existing at the time of design and of technical and economic considerations compatible with a high level of protection of health and safety; Whereas Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (7) is the first case of application of the new approach to the field of medical devices; whereas in the interest of uniform Community rules applicable to all medical devices, this Directive is based largely on the provisions of Directive 90/385/EEC; whereas for the same reasons Directive 90/385/EEC must be amended to insert the general provisions laid down in this Directive; Whereas the electromagnetic compatibility aspects form an integral part of the safety of medical devices; whereas this Directive should contain specific rules on this subject with regard to Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility (8); Whereas this Directive should include requirements regarding the design and manufacture of devices emitting ionizing radiation; whereas this Directive does not affect the authorization required by Council Directive 80/836/Euratom of 15 July 1980 amending the Directives laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation (9), nor application of Council Directive 84/466/Euratom of 3 September 1984 laying down basic measures for the radiation protection of persons undergoing medical examination or treatment (10); whereas Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (11) and the specific directives on the same subject should continue to apply; Whereas, in order to demonstrate conformity with the essential requirements and to enable conformity to be verified, it is desirable to have harmonized European standards to protect against the risks associated with the design, manufacture and packaging of medical devices; whereas such harmonized European standards are drawn up by private-law bodies and should retain their status as non-mandatory texts; whereas, to this end, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as the competent bodies for the adoption of harmonized standards in accordance with the general guidelines on cooperation between the Commission and these two bodies signed on 13 November 1984; Whereas, for the purpose of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted, on a mandate from the Commission, by either or both of these bodies in accordance with Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (12), and pursuant to the abovementioned general guidelines; whereas with regard to possible amendment of the harmonized standards, the Commission should be assisted by the Committee set up pursuant to Directive 83/189/EEC; whereas the measures to be taken must be defined in line with procedure I, as laid down in Council Decision 87/373/EEC (13); whereas, for specific fields, what already exists in the form of European Pharmacopoeia monographs should be incorporated within the framework of this Directive; whereas, therefore, several European Pharmacopoeia monographs may be considered equal to the abovementioned harmonized standards; Whereas, in Decision 90/683/EEC of 13 December 1990 concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonization directives (14), the Council has laid down harmonized conformity assessment procedures; whereas the application of these modules to medical devices enables the responsibility of manufacturers and notified bodies to be determined during conformity assessment procedures on the basis of the type of devices concerned; whereas the details added to these modules are justified by the nature of the verification required for medical devices; Whereas it is necessary, essentially for the purpose of the conformity assessment procedures, to group the devices into four product classes; whereas the classification rules are based on the vulnerability of the human body taking account of the potential risks associated with the technical design and manufacture of the devices; whereas the conformity assessment procedures for Class I devices can be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products; whereas, for Class IIa devices, the intervention of a notified body should be compulsory at the production stage; whereas, for devices falling within Classes IIb and III which constitute a high risk potential, inspection by a notified body is required with regard to the design and manufacture of the devices; whereas Class III is set aside for the most critical devices for which explicit prior authorization with regard to conformity is required for them to be placed on the market; Whereas in cases where the conformity of the devices can be assessed under the responsibility of the manufacturer the competent authorities must be able, particularly in emergencies, to contact a person responsible for placing the device on the market and established in the Community, whether the manufacturer or another person established in the Community and designated by the manufacturer for the purpose; Whereas medical devices should, as a general rule, bear the CE mark to indicate their conformity with the provisions of this Directive to enable them to move freely within the Community and to be put into service in accordance with their intended purpose; Whereas, in the fight against AIDS and in the light of the conclusions of the Council adopted on 16 May 1989 regarding future activities on AIDS prevention and control at Community level (15), medical devices used for protection against the HIV virus must afford a high level of protection; whereas the design and manufacture of such products should be verified by a notified body; Whereas the classification rules generally enable medical devices to be appropriately classified; whereas, in view of the diverse nature of the devices and technological progress in this field, steps must be taken to include amongst the implementing powers conferred on the Commission the decisions to be taken with regard to the proper classification or reclassification of the devices or, where appropriate, the adjustment of the classification rules themselves; whereas since these issues are closely connected with the protection of health, it is appropriate that these decisions should come under procedure IIIa, as provided for in Directive 87/373/EEC; Whereas the confirmation of complicance with the essential requirements may mean that clinical investigations have to be carried out under the responsibility of the manufacturer; whereas, for the purpose of carrying out the clinical investigations, appropriate means have to be specified for the protection of public health and public order; Whereas the protection of health and the associated controls may be made more effective by means of medical device vigilance systems which are integrated at Community level; Whereas this Directive covers the medical devices referred to in Council Directive 76/764/EEC of 27 July 1976 on the approximation of the laws of the Member States on clinical mercury-in-glass, maximum reading thermometers (16); whereas the abovementioned Directive must therefore be repealed; whereas for the same reasons Council Directive 84/539/EEC on 17 September 1984 on the approximation of the laws of the Member States relating to electro-medical equipment used in human or veterinary medicine (17) must be amended, Article 1 Definitions, scope 1. This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices. 2. For the purposes of this Directive, the following definitions shall apply: (a) 'medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: - diagnosis, prevention, monitoring, treatment or alleviation of disease, - diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, - investigation, replacement or modification of the anatomy or of a physiological process, - control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means; (b) 'accessory' means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device; (c) 'device used for in vitro diagnosis' means any device which is a reagent, reagent product, kit, instrument, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of samples derived from the human body with a view to providing information on the physiological state, state of health or disease, or congenital abnormality thereof; (d) 'custom-made device' means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. The abovementioned prescription may also be made out by any other person authorized by virtue of his professional qualifications to do so. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user are not considered to be custom-made devices; (e) 'device intended for clinical investigation' means any device intended for use by a duly qualified medical practitioner when conducting investigations as referred to in Section 2.1 of Annex X in an adequate human clinical environment. For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorized to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner; (f) 'manufacturer' means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party. The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient; (g) 'intended purpose' means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials; (h) 'placing on the market' means the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished; (i) 'putting into service' means the stage at which a device is ready for use on the Community market for the first time for its intended purpose. 3. Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 65/65/EEC, that device shall be governed by the present Directive, without prejudice to the provisions of Directive 65/65/EEC with regard to the medicinal product. If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by Directive 65/65/EEC. The relevant essential requirements of Annex I to the present Directive shall apply as far as safety and performance related device features are concerned. 4. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 65/65/EEC and which is liable to act upon the body with action ancillary to that of the device, that device must be assessed and authorized in accordance with this Directive. 5. This Directive does not apply to: (a) in vitro diagnostic devices; (b) active implantable devices covered by Directive 90/385/EEC; (c) medicinal products covered by Directive 65/65/EEC; (d) cosmetic products covered by Directive 76/768/EEC (18); (e) human blood, human blood products, human plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells; (f) transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin; (g) transplants or tissues or cells of animal origin, unless a device is manufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissue. 6. This Directive does not apply to personal protective equipment covered by Directive 89/686/EEC. In deciding whether a product falls under that Directive or the present Directive, particular account shall be taken of the principal intended purpose of the product. 7. This Directive is a specific Directive within the meaning of Article 2 (2) of Directive 89/336/EEC. 8. This Directive does not affect the application of Directive 80/836/Euratom, nor of Directive 84/466/Euratom. Article 2 Placing on the market and putting into service Member States shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they do not compromise the safety and health of patients, users and, where applicable, other persons when properly installed, maintained and used in accordance with their intended purpose. Article 3 Essential requirements The devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned. Article 4 Free movement, devices intended for special purposes 1. Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the CE marking provided for in Article 17 which indicate that they have been the subject of an assessment of their conformity in accordance with the provisions of Article 11. 2. Member States shall not create any obstacle to: - devices intended for clinical investigation being made available to medical practitioners or authorized persons for that purpose if they meet the conditions laid down in Article 15 and in Annex VIII, - custom-made devices being placed on the market and put into service if they meet the conditions laid down in Article 11 in combination with Annex VIII; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII. These devices shall not bear the CE marking. 3. At trade fairs, exhibitions, demonstrations, etc. 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. 4. Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use. 5. Where the devices are subject to other Directives concerning other aspects and which also provide for the affixing of the CE marking, the latter shall indicate that the devices also fulfil the provisions of the other Directives. However, should one or more of these directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the devices fulfil the provisions only of those directives applied by the manufacturer. In this case, the particulars of these directives, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the directives and accompanying such devices. Article 5 Reference to standards 1. Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices which are in conformity with the relevant national standards adopted pursuant to the harmonized standards the references of which have been publishes in the Official Journal of the European Communities; Member States shall publish the references of such national standards. 2. For the purposes of this Directive, reference to harmonized standards also includes the monographs of the European Pharmacopoeia notably on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, the references of which have been published in the Official Journal of the European Communities. 3. If a Member State or the Commission considers that the harmonized standards do not entirely meet the essential requirements referred to in Article 3, the measures to be taken by the Member States with regard to these standards and the publication referred to in paragraph 1 of this Article shall be adopted by the procedure defined in Article 6 (2). Article 6 Committee on Standards and Technical Regulations 1. The Commission shall be assisted by the Committee set up by Article 5 of Directive 83/189/EEC. 2. The representative of the Commission 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 shall have the right to 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 7 Committee on Medical Devices 1. The Commission shall be assisted by the Committee set up by Article 6 (2) of Directive 90/385/EEC. 2. The representative of the Commission 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. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. If 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 relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. 4. The Committee may examine any question connected with implementation of this Directive. Article 8 Safeguard clause 1. Where a Member State ascertains that the devices referred to in Article 4 (1) and (2) second indent, when correctly installed, maintained and used for their intended purpose, may compromise the health and/or safety of patients, users or, where applicable, other persons, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service. The Member State shall immediately inform the Commission of any such measures, indicating the reasons for its decision and, in particular, whether non-compliance with this Directive is due to: (a) failure to meet the essential requirements referred to in Article 3; (b) incorrect application of the standards referred to in Article 5, in so far as it is claimed that the standards have been applied; (c) shortcomings in the standards themselves. 2. The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that: - the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States; where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the parties concerned, bring the matter before the Committee referred to in Article 6 (1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the procedures referred to in Article 6, - the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorized representative established within the Community. 3. Where a non-complying device bears the CE marking, the competent Member State shall take appropriate action against whomsoever has affixed the mark and shall inform the Commission and the other Member States thereof. 4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure. Article 9 Classification 1. Devices shall be divided into Classes I, IIa, IIb and III. Classification shall be carried out in accordance with Annex IX. 2. In the event of a dispute between the manufacturer and the notified body concerned, resulting from the application of the classification rules, the matter shall be referred for decision to the competent authority to which the notified body is subject. 3. The classification rules set out in Annex IX may be adapted in accordance with the procedure referred to in Article 7 (2) in the light of technical progress and any information which becomes available under the information system provided for in Article 10. Article 10 Information on incidents occuring following placing of devices on the market 1. Member States shall take the necessary steps to ensure that any information brought to their knowledge, in accordance with the provisions of this Directive, regarding the incidents mentioned below involving a Class I, IIa, IIb or III device is recorded and evaluated centrally: (a) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health; (b) any technical or medical reason in relation to the characteristics or performance of a device for the reasons referred to in subparagraph (a), leading to systematic recall of devices of the same type by the manufacturer. 2. Where a Member State requires medical practitioners or the medical institutions to inform the competent authorities of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorized representative established in the Community, is also informed of the incident. 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. Article 11 Conformity assessment procedures 1. In the case of devices falling within Class III, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either: (a) follow the procedure relating to the EC declaration of conformity set out in Annex II (full quality assurance); or (b) follow the procedure relating to the EC type-examination set out in Annex III, coupled with: (i) the procedure relating to the EC verification set out in Annex IV; or (ii) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance). 2. In the case of devices falling within Class IIa, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure relating to the EC declaration of conformity set out in Annex VII, coupled with either: (a) the procedure relating to the EC verification set out in Annex IV; or (b) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance); or (c) the procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance). Instead of applying these procedures, the manufacturer may also follow the procedure referred to in paragraph 3 (a). 3. In the case of devices falling within Class IIb, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either: (a) follow the procedure relating to the EC declaration of conformity set out in Annex II (full quality assurance); in this case, point 4 of Annex II is not applicable; or (b) follow the procedure relating to the EC type-examination set out in Annex III, coupled with: (i) the procedure relating to the EC verification set out in Annex IV; or (ii) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance); or (iii) the procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance). 4. The Commission shall, no later than five years from the date of implementation of this Directive, submit a report to the Council on the operation of the provisions referred to in Article 10 (1), Article 15 (1), in particular in respect of Class I and Class IIa devices, and on the operation of the provisions referred to in Annex II, Section 4.3 second and third subparagraphs and in Annex III, Section 5 second and third subparagraphs to this Directive, accompanied, if necessary, by appropriate proposals. 5. In the case of devices falling within Class I, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex VII and draw up the EC declaration of conformity required before placing the device on the market. 6. In the case of custom-made devices, the manufacturer shall follow the procedure referred to in Annex VIII and draw up the statement set out in that Annex before placing each device on the market. Member States may require that the manufacturer shall submit to the competent authority a list of such devices which have been put into service in their territory. 7. During the conformity assessment procedure for a device, the manufacturer and/or the notified body shall take account of the results of any assessment and verification operations which, where appropriate, have been carried out in accordance with this Directive at an intermediate stage of manufacture. 8. The manufacturer may instruct his authorized representative established in the Community to initiate the procedures provided for in Annexes III, IV, VII and VIII. 9. Where the conformity assessment procedure involves the intervention of a notified body, the manufacturer, or his authorized representative established in the Community, may apply to a body of his choice within the framework of the tasks for which the body has been notified. 10. The notified body may require, where duly justified, any information or data, which is necessary for establishing and maintaining the attestation of conformity in view of the chosen procedure. 11. Decisions taken by the notified bodies in accordance with Annexes II and III shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both parties, for further periods of five years. 12. The records and correspondence relating to the procedures referred to in paragraphs 1 to 6 shall be in an official language of the Member State in which the procedures are carried out and/or in another Community language acceptable to the notified body. 13. By derogation from paragraphs 1 to 6, the competent authorities may authorize, on duly justified request, the placing on the market and putting into service, within the territory of the Member State concerned, of individual devices for which the procedures referred to in paragraphs 1 to 6 have not been carried out and the use of which is in the interest of protection of health. Article 12 Particular procedure for systems and procedure packs 1. By way of derogation from Article 11 this Article shall apply to systems and procedure packs. 2. Any natural or legal person who puts devices bearing the CE marking together within their intended purpose and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack, shall draw up a declaration by which he states that: (a) he has verified the mutual compatibility of the devices in accordance with the manufacturers' instructions and has carried out his operations in accordance with these instructions; and (b) he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers; and (c) the whole activity is subjected to appropriate methods of internal control and inspection. Where the conditions above are not met, as in cases where the system or procedure pack incorporate devices which do not bear a CE marking or where the chosen combination of devices is not compatible in view of their original intended use, the system or procedure pack shall be treated as a device in its own right and as such be subjected to the relevant procedure pursuant to Article 11. 3. Any natural or legal person who sterilized, for the purpose of placing on the market, systems or procedure packs referred to in paragraph 2 or other CE-marked medical devices designed by their manufacturers to be sterilized before use, shall, at his choice, follow one of the procedures referred to in Annex IV, V or VI. The application of the abovementioned Annexes and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility. The person shall draw up a declaration stating that sterilization has been carried out in accordance with the manufacturer's instructions. 4. The products referred to in paragraphs 2 and 3 themselves shall not bear an additional CE marking. They shall be accompanied by the information referred to in point 13 of Annex I which includes, where appropriate, the information supplied by the manufacturers of the devices which have been put together. The declaration referred to in paragraphs 2 and 3 above shall be kept at the disposal of competent authorities for a period of five years. Article 13 Decisions with regard to classification, derogation clause 1. Where a Member State considers that: (a) application of the classification rules set out in Annex IX requires a decision with regard to the classification of a given device or category of devices; or (b) a given device or family of devices should be classified, by way of derogation from the provisions of Annex IX, in another class; or (c) the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 11, by applying solely one of the given procedures chosen from among those referred to in Article 11, it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures. These measures shall be adopted in accordance with the procedure referred to in Article 7 (2). 2. The Commission shall inform the Member States of the measures taken and, where appropriate, publish the relevant parts of these measures in the Official Journal of the European Communities. Article 14 Registration of persons responsible for placing devices on the market 1. Any manufacturer who, under his own name, places devices on the market in accordance with the procedures referred to in Article 11 (5) and (6) and any other natural or legal person engaged in the activities referred to in Article 12 shall inform the competent authorities of the Member State in which he has his registered place of business of the address of the registered place of business and the description of the devices concerned. 2. Where a manufacturer who places devices referred to in paragraph 1 on the market under his own name does not have a registered place of business in a Member State, he shall designate the person(s) responsible for marketing them who is (are) established in the Community. These persons shall inform the competent authorities of the Member State in which they have their registered place of business of the address of the registered place of business and the category of devices concerned. 3. The Member States shall on request inform the other Member States and the Commission of the details referred to in paragraphs 1 and 2. Article 15 Clinical investigation 1. In the case of devices intended for clinical investigations, the manufacturer, or his authorized representative established in the Community, shall follow the procedure referred to in Annex VIII and notify the competent authorities of the Member States in which the investigations are to be conducted. 2. In the case of devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of 60 days after notification, unless the competent authorities have notified him within that period of a decision to the contrary based on considerations of public health or public policy. Member States may however authorize manufacturers to commence the relevant clinical investigations before the expiry of the period of 60 days, in so far as the relevant ethics committee has issued a favourable opinion on the programme of investigation in question. 3. In the case of devices other than those referred to in the second paragraph, Member States may authorize manufacturers to commence clinical investigations, immediately after the date of notification, provided that the ethics committee concerned has delivered a favourable opinion with regard to the investigational plan. 4. The authorization referred to in paragraph 2 second subparagraph and paragraph 3, may be made subject to authorization from the competent authority. 5. The clinical investigations must be conducted in accordance with the provisions of Annex X. The provisions of Annex X may be adjusted in accordance with the procedure laid down in Article 7 (2). 6. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. 7. The manufacturer or his authorized representative established in the Community shall keep the report referred to in point 2.3.7 of Annex X at the disposal of the competent authorities. 8. The provisions of paragraphs 1 and 2 do not apply where the clinical investigations are conducted using devices which are authorized in accordance with Article 11 to bear the CE marking unless the aim of these investigations is to use the devices for a purpose other than that referred to in the relevant conformity assessment procedure. The relevant provisions of Annex X remain applicable. Article 16 Notified bodies 1. The Member States shall notify the Commission and other Member States of the bodies which they have designated for carrying out the tasks pertaining to the procedures referred to in Article 11 and the specific tasks for which the bodies have been designated. The Commission shall assign identification numbers to these bodies, hereinafter referred to as 'notified bodies'. The Commission shall publish a list of the notified bodies, together with the identification numbers it has allocated to them and the tasks for which they have been notified, in the Official Journal of the European Communities. It shall ensure that the list is kept up to date. 2. Member States shall apply the criteria set out in Annex XI for the designation of bodies. Bodies that meet the criteria laid down in the national standards which transpose the relevant harmonized standards shall be presumed to meet the relevant criteria. 3. A Member State that has notified a body shall withdraw that notification if it finds that the body no longer meets the criteria referred to in paragraph 2. It shall immediately inform the other Member States and the Commission thereof. 4. The notified body and the manufacturer, or his authorized representative established in the Community, shall lay down, by common accord, the time limits for completion of the assessment and verification operations referred to in Annexes II to VI. Article 17 CE marking 1. Devices, other than devices which are custom-made or intended for clinical investigations, considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market. 2. The CE marking of conformity, as shown in Annex XII, must appear in a visible, legible and indelible form on the device or its sterile pack, where practicable and appropriate, and on the instructions for use. Where applicable, the CE marking must also appear on the sales packaging. It shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Annexes II, IV, V and VI. 3. It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the CE marking. Any other mark may be affixed to the device, to the packaging or to the instruction leaflet accompanying the device provided that the visibility and legibility of the CE marking is not thereby reduced. Article 18 Wrongly affixed CE marking Without prejudice to Article 8: (a) where a Member State establishes that the CE marking has been affixed unduly, the manufacturer or his authorized representative established within the Community shall be obliged to end the infringement under conditions imposed by the Member State; (b) where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market, in accordance with the procedure in Article 8. Article 19 Decision in respect of refusal or restriction 1. Any decision taken pursuant to this Directive: (a) to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations; or (b) to withdraw devices from the market, shall state the exact grounds on which it is based. Such decisions shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the national law in force in the Member State in question and of the time limits to which such remedies are subject. 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. Article 20 Confidentiality Without prejudice to the existing national provisions and practices on medical secrets, Member States shall ensure that all the parties involved in the application of this Directive are bound to observe confidentiality with regard to all information obtained in carrying out their tasks. This does not affect the obligation of Member States and notified bodies with regard to mutual information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law. Article 21 Repeal and amendment of Directives 1. Directive 76/764/EEC is hereby repealed with effect from 1 January 1995. 2. In the title and Article 1 of Directive 84/539/EEC, 'human or' is deleted. In Article 2 of Directive 84/539/EEC, the following subparagraph is added to paragraph 1: 'If the appliance is at the same time a medical device within the meaning of Directive 93/42/EEC (*) and if it satisfies the essential requirements laid down therein for that device, the device shall be deemed to be in conformity with the requirements of this Directive. (*) OJ No L 169, 12. 7. 1993, p. 1.' 3. Directive 90/385/EEC is hereby amended as follows: 1. in Article 1 (2) the following two subparagraphs are added: '(h) "placing on the market " means the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished; (i) "manufacturer " means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party. The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient;' 2. in Article 9 the following paragraphs are added: '5. During the conformity assessment procedure for a device, the manufacturer and/or the notified body shall take account of the results of any assessment and verification operations which, where appropriate, have been carried out in accordance with this Directive at an intermediate stage of manufacture. 6. Where the conformity assessment procedure involves the intervention of a notified body, the manufacturer, or his authorized representative established in the Community, may apply to a body of his choice within the framework of the tasks for which the body has been notified. 7. The notified body may require, where duly justified, any information or data which is necessary for establishing and maintaining the attestation of conformity in view of the chosen procedure. 8. Decisions taken by the notified bodies in accordance with Annexes II and III shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both parties, for further periods of five years. 9. By derogation from paragraphs 1 and 2 the competent authorities may authorize, on duly justified request, the placing on the market and putting into service, within the territory of the Member State concerned, of individual devices for which the procedures referred to in paragraphs 1 and 2 have not been carried out and the use of which is in the interest of protection of health.'; 3. the following Article 9a is inserted after Article 9: 'Article 9a 1. Where a Member State considers that the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 9, by applying solely one of the given procedures chosen from among those referred to in Article 9, it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures. These measures shall be adopted in accordance with the procedure referred to in Article 7 (2) of Directive 93/42/EEC (*). 2. The Commission shall inform the Member States of the measures taken and, where appropriate, publish the relevant parts of these measures in the Official Journal of the European Communities. (*) OJ No L 169, 12. 7. 1993, p. 1.' 4. Article 10 shall be amended as follows: - the following subparagraph shall be added to paragraph 2: 'Member States may however authorize manufacturers to start the clinical investigations in question before the expiry of the 60-day period, provided that the Ethical Committee concerned has delivered a favourable opinion with respect to the investigation programme in question.', - the following paragraph shall be inserted: '2a. The authorization referred to in the second subparagraph of paragraph 2 may be subject to approval by the competent authority.'; 5. the following is added to Article 14: 'In the event of a decision as referred to in the previous paragraph 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 measures to be taken.' Article 22 Implementation, transitional provisions 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1994. They shall immediately inform the Commission thereof. The Standing Committee referred to in Article 7 may assume its tasks from the date of notification (19) of this Directive. The Member States may take the measures referred to in Article 16 on notification of this Directive. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such a reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Member States shall apply these provisions with effect from 1 January 1995. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. 3. Member States shall take the necessary action to ensure that the notified bodies which are responsible pursuant to Article 11 (1) to (5) for conformity assessment take account of any relevant information regarding the characteristics and performance of such devices, including in particular the results of any relevant tests and verification already carried out under pre-existing national law, regulations or administrative provisions in respect of such devices. 4. Member States shall accept the placing on the market and putting into service of devices which conform to the rules in force in their territory on 31 December 1994 during a period of five years following adoption of this Directive. In the case of devices which have been subjected to EEC pattern approval in accordance with Directive 76/764/EEC, Member States shall accept their being placed on the market and put into service during the period up to 30 June 2004. Article 23 This Directive is addressed to the Member States.