Datasets:

eu_regulatory_ir

like 2

31989L0106

1988

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 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 Member States are responsible for ensuring that building and civil engineering works on their territory are designed and executed in a way that does not endanger the safety of persons, domestic animals and property, while respecting other essential requirements in the interests of general well-being; Whereas Member States have provisions, including requirements, relating not only to building safety but also to health, durability, energy economy, protection of the environment, aspects of economy, and other aspects important in the public interest; Whereas these requirements, which are often the subject of national provisions laid down by law, regulation or administrative action, have a direct influence on the nature of construction products employed and are reflected in national product standards, technical approvals and other technical specifications and provisions which, by their disparity, hinder trade within the Community; Whereas paragraph 71 of the White Paper on completing the internal market, approved by the European Council in June 1985, states that, within the general policy, particular emphasis will be placed on certain sectors, including construction; whereas the removal of technical barriers in the construction field, to the extent that they cannot be removed by mutual recognition of equivalence among all the Member States, should follow the new approach set out in the Council resolution of 7 May 1985 (4) which calls for the definition of essential requirements on safety and other aspects which are important for the general well-being, without reducing the existing and justified levels of protection in the Member States; Whereas the essential requirements constitute both the general and specific criteria with which construction works must comply; whereas such requirements are to be understood as requiring that the said works conform with an appropriate degree of reliability with one, some or all of these requirements when and where this is laid down in regulations; Whereas, as a basis for the harmonized standards or other technical specifications at European level and for the drawing up or granting of European technical approval, interpretative documents will be established in order to give concrete form to the essential requirements at a technical level; Whereas these essential requirements provide the basis for the preparation of harmonized standards at European level for construction products; whereas, in order to achieve the greatest possible advantage for a single internal market,to afford access to that market for as many mannifacturers as possible, to ensure the greatest possible degree of market transparency and to create the conditions for a harmonized system of general rules in the construction industry, harmonized standards should be established as far as, and as quickly as, possible; whereas these standards are drawn up by private bodies and must remain non-mandatory texts; whereas, for that purpose, 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 for cooperation between the Commission and those two bodies signed on 13 November 1984; whereas, for the purposes of this Directive, a harmonized standard is a technical specification (European standard or harmonized document) adopted by one or both of those bodies upon a mandate given by the Commission in accordance with the provisions of Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (5); Whereas the special nature of construction products requires the precise formulation of these harmonized standards; whereas it is therefore necessary to draw up interpretative documents in order to establish links between mandates for standards and the essential requirements; whereas harmonized standards, expressed as far as possible in terms. of product performance, take account of these interpretative documents, which shall be drawn up in cooperation with the Member States; Whereas performance levels and requirements to be fulfilled by products in future in the Member States shall be laid down in classes in the interpretative documents and in the harmonized technical specifications in order to take account of different levels of essential requirements for certain works and of different conditions prevailing in the Member States; Whereas harmonized standards should include classifications that allow construction products which meet the essential requirements and which are produced and used lawfully in accordance with technical traditions warranted by local climatological and other conditions to continue to be placed on the market; Whereas a product is presumed fit for use if it conforms to a harmonized standard, a European technical approval or a non-harmonized technical specification recognized at Community level; whereas, in cases where products are of little importance with respect to the essential requirements and where they deviate from existing technical specifications, their fitness for use can be certified by recourse to an approved body; Whereas products thus considered fit for use are easily recognizable by the EC mark; whereas they must be allowed free movement and free use for their intended purpose throughout the Community; Whereas, in the case of products where European standards cannot be produced or foreseen within a reasonable period of time or of products which deviate substantially from a standard, the fitness for use of such products may be proved by recourse to European technical approvals on the basis of common guidelines; whereas the common guidelines for the granting of European technical approvals will be adopted on the basis of the interpretative documents; Whereas, in the absence of harmonized standards and European technical approvals, national or other non-harmonized technical specifications may be recognized as providing a suitable basis for a presumption that the essential requirements are met; Whereas it is necessary to ensure the conformity of products with harmonized standards and with non-harmonized technical specifications recognized at European level by means of procedures of production control by manufacturers and of supervision, testing assessment and certification by independent qualified third parties, or by the manufacturer himself; Whereas a special procedure should be provided as an interim measure for products where standards or technical approvals recognized at European level do not yet exist; whereas this procedure should facilitate recognition of the results of tests performed in another Member State according to the technical requirements of the Member State of destination; Whereas a Standing Committee on Construction should be set up comprising experts designated by Member States to assist the Commission on questions arising from the implementation and practical application of this Directive; Whereas the responsibility of Member States for safety, health and other matters covered by the essential requirements on their territory should be recognized in a safeguard clause providing for appropriate protective measures, CHAPTER I Field of application - Definitions - Requirements Technical specifications - Free movement of goods Article 1 1. This Directive shall apply to construction products in so far as the essential requirements in respect of construction works under Article 3 (1) relate to them 2. For the purposes of this Directive, 'construction product' means any product which is produced for incorporation in a permanent manner in construction works, including both buildings and civil engineering works. 'Construction Products' are hereinafter referred to as 'products'; construction works including both buildings and civil engineering works are hereinafter referred to as 'works'. Article 2 1. Member States shall take all necessary measures to ensure that the products referred to in Article 1, which are intended for use in works, may be placed on the market only if they are fit for this intended use, that is to say they have such characteristics that the works in which they are to be incorporated, assembled, applied or installed, can, if properly designed and built, satisfy the essential requirements referred to in Article 3 when and where such works are subject to regulations containing such requirements. 2. When products are subject to other Community directives with regard to other aspects, the EC conformity mark, hereinafter referred to as the 'EG mark', referred to in Article 4 (2) shall indicate in these cases that the requirements of those other directives have also been complied with. 3. When a future directive concerns mainly other aspects and only to a minor extent the essential requirements of this Directive, that subsequent directive shall contain provisions ensuring that it also covers the requirements of this Directive. 4. This Directive shall not affect the right of Member States to specify - with due observance of the provisions of the Treaty - the requirements they deem necessary to ensure that workers are protected when using products, provided it does not mean the products are modified in a way unspecified in this Directive Article 3 1. The essential requirements applicable to works which may influence the technical characteristics of a product are set out in terms of objectives in Annex I. One, some or all of these requirements may apply; they shall be satisfied during an economically reasonable working life. 2. In order to take account of possible differences in geographical or climatic conditions or in ways of life as well as different levels of protection that may prevail at national, regional or local level, each essential requirement may give rise to the establishment of classes in the documents referred to in paragraph 3 and the technical specifications referred to in Article 4 for the requirement to be respected. 3. The essential requirements shall be given concrete form in documents (interpretative documents) for the creation of the necessary links between the essential requirements laid down in paragraph 1 and the standardization mandates, mandates for guidelines for European technical approval or the recognition of other technical specifications within the meaning of Articles 4 and 5. Article 4 1. Standards and technical approvals shall, for the purposes of ehis Directive, be referred to as 'technical specifications' For the purposes of this Directive, harmonized standards shall be the technical specifications adopted by CEN, Cenelec or both, on mandates given by the Commission in conformity with Directive 83/189/EEC on the basis of an opinion given by the Committee referred to in Article 19 and in accordance with the general provisions concerning cooperation between the Commission and these two bodies signed on 13 November 1984. 2. Member States shall presume that the products are fit for their intended use if they enable works in which they are employed, provided the latter are properly designed and. built, to satisfy the essential requirements referred to in Article 3, and those products bear the EC mark. The EC mark shall indicate: (a) that they comply with the relevant national standards transposing the harmonized standards, references to which have been published in the Official Journal of the European Countries. Member States shall publish the references of these national standards: (b) that they comply with a European technical approval, delivered according to the procedure of Chapter III, or (c) that they comply with the national technical specifications referred to in paragraph 3 in as much as harmonized specifications do not exist; a list of these national specifications shall be drawn up according to the procedure in Article 5 (2). 3. Member States may communicate to the Commission the texts of their national technical specifications which they regard as complying with the essential requirements referred to in Article 3. The Commission shall forward these national technical specifications forthwith to the other Member States. In accordance with the procedure provided for in Article 5 (2), it shall notify the Member States of those national technical specificationsion respect of which there is presumption of conformity with the essential requirements referred to in Article 3. This procedure will be initiated and managed by the Commission in consultation with the committee referred to in Article 19 Member States shall publish the references to these technical specifications. The Commission shall also publish them in the Official Journal of the European Countries 4. Where a manufacturer, or his agent, established in the Community, has not applied, or has applied only in part, the existing technical specifications referred to in paragraph 2, which require, according to the criteria set out in Article 13 (4), the product to be submitted for a declaration of conformity as defined in Annex III (2) (ii), second and third possibilities, the corresponding decisions under Article 13 (4) and Annex III shall apply and such a product's fitness for use within the meaning of Article 2 (1) shall be established in accordance with the procedure set out in Annex III (2) (ii), second possibility. 5. The Commission, in consultation with the committee referred to in Article 19, shall draw up, manage and revise periodically a list of products which play a minor part with respect to health and safety and in respect of which a declaration of compliance with the 'acknowledged rule of technology', issued by the manufacturer, will authorize such products to be placed on the market. 6. The EC mark signifies that products satisfy the requirements of paragraphs 2 and 4 of this Article. It is for the manufacturer, or his agent established in the Community, to take responsibility for affixing the EC mark on the product itself, on a label attached to it, on its packaging, or on the accompanying commercial documents. The model of the EC mark and conditions of its use are given in Annex III. products referred to in paragraph 5 shall not bear the EC mark. Article 5 1. Where a Member State or the Commission is of the opinion that the harmonized standards or European technical approvals referred to in Article 4 (2), points (a) and (b), or the mandates referred to in Chapter II, do not satisfy the provisions of Articles 2 and 3, that Member State or the Commission shall notify the committee referred to in Article 19, setting out its reasons. The committee shall deliver an urgent opinion. In the light of the opinion of the committee, and after consuItation with the committee set up under Directive 83/189/EEC where it concerns harmonized standards, the Commission shall inform Member States if the standards or approvals concerned should be withdrawn in the publications referred to in Article 7 (3). 2. On reception of the communication referred to in Article 4 (3), the Commission shall consult the committee referred to in Article 19. In the light of the opinion of the committee, the Commission shall notify Member States whether the technical specification in question should benefit from the presumption of conformity and, if so, publish a reference to it in the Official Journal of the European Countries. If the Commission or a Member State believes that a technical specification no longer fulfills the conditions necessary for presumption of conformity with the provisions of Articles 2 and 3, the Commission shall consult the committee referred to in Article 19. In the light of the opinion of the said committee, the Commission shall notify the Member States whether the national technical specification in question should continue to benefit from presumption of conformity, and, if not, whether the reference to it referred to in Article 4 (3) should be withdrawn. Article 6 1. Member States shall not impede the free movement, placing on the market or use in their territory of products which satisfy the provisions of this Directive Member States shall ensure that the use of such products, for the purpose for which they were intended, shall not be impeded by rules or conditions imposed by public bodies or. private bodies acting as a public undertaking or acting as a public body on the basis of a monopoly position. 2. Member States shall, however, allow products not covered by Article 4 (2)to be placed on the market in their territory if they satisfy national provisions consistent with the Treaty until the European technical specifications referred to in Chapters II and III provide otherwise. The Commission and the committee referred to in Article 19 will monitor and review the development of the European technical specifications on a regular basis. 3. If the relevant European technical specifications, either themselves or on the basis of the interpretative documents referred to in Article 3 (3), distinguish between different classes corresponding to different performance levels, Member States may determine the performance levels also to be observed in their territory only within the classifications adopted at Community level and only subject to the use of all or some classes or one class. CHAPTER II Harmonized standards Article 7 1. In order to ensure the quality of harmonized standards for products, the standards shall be established by the European standards organizations on the basis of mandates given by the Commission in accordance with the procedure laid down in Directive 83/189/EEC and, after consulting the committee referred to in Article 19, in accordance with the general provisions concerning cooperation between the Commission and these bodies signed on 13 November 1984. 2. The resulting standards shall be expressed as far as practicable in product performance terms, having regard to the interpretative documents. 3. Once the standards have been established by the European standards organizations, the Commission shall publish the references of the standards in the 'C' series of the Official Official Journal of the European Countries. CHAPTER III European technical approval Article 8 1. European technical approval is a favourable technical assessment of the fitness for use of a product for an intended use, based on fulfilment of the essential requirements for building works for which the product is us2. European technical approval may be granted to: (a) products for which there is neither a harmonized standard, nor a recognized national standard, nor a mandate for a harmonized standard, and for which the Commission, after consulting the committee referred to in Article 19, considers that a standard could not, or not yet, be elaborated; and (b) products which differ significantly from harmonized or recognized national standards. Even in the case where a mandate for a harmonized standard has been issued, the provisions referred to in (a) do not exclude the granting of European technical approval for products for which guidelines for such approval exist. This shall apply until the entry into force of the harmonized standard in the Member States. 3. In special cases, the Commission may, as a derogation from paragraph 2 (a), authorize the issue of European technical approval, after consulting the committee referred to in Article 19, for products for which there is a mandate for a harmonized standard, or for which the Commission has established that a harmonized standard can be elaborated. The authorization shall be valid for a fixed period. 4. European technical approval shall in general be issued for a five-year period. This period may be extended Article 9 1. European technical approval for a product shall be based on examinations, tests and an assessment on the basis of the interpretative documents referred to in Article 3 (3) and of the guidelines referred to in Article 11 for this product or the corresponding family of products. 2. Where guidelines referred to in Article 11 do not or not yet exist, European technical approval may be issued by reference to the relevant essential requirements and the interpretative documents where the assessment of the product is adopted by the approval bodies acting jointly in the organization referred to in Annex II. If the approval bodies cannot agree, the matter shall be referred to the committee referred to in Article 19. 3. The European technical approval for a product shall be issued in a Member State in accordance with the procedure laid down in Annex II at the request of the manufacturer or his agent established in the Community. Article 10 1. Each Member State shall notify the other Member States and the Commission of the names and addresses of the bodies which it has authorized to issue European technical approvals. 2. The approval bodies must satisfy the requirements of chis Directive and in particular must be able: - to assess the fitness for use of new products on the basis of scientific and practical knowledge, - to take impartial decisions in relation to the interests of the manufacturers concerned or their agents, and - to collate the contributions of all the interested parties in a balanced assessment. 3. The list of approval bodies which are competent to issue European technical approvals, as well as any amendments to that list, shall be published in the'G' series of the Official Official Journal of the European Countries. Article 11 1. The Commission shall, after consulting the committee referred to in Article 19, issue mandates for establishing guidelines for European technical approval for a product or family of products to the organization of approval bodies designated by the Member States. 2. The guidelines for European technical approval for a product or family of products should contain the following, in particular: (a) a list of the relevant interpretative documents referred to in Article 3 (3); (b) specific requirements for the products within the meaning of the essential requirements referred to in Article 3 (1); (c) the test procedures; (d) method of assessing and judging the resuIts of the tests; (e) the inspection and conformity procedures which must correspond to Articles 13, 14 and 15; (f) the period of validity of the European technical approval. 3. The guidelines for European technical approval shall, after consultation with the committee referred to in Article 19, be published by the Member States in their official language or languages. CHAPTER IV Interpretative documents Article 12 1. The Commission shall, after consulting the committee referred to in Article 19, instruct technical committees in which the Member States participate to draw up the interpretative documents referred to in Article 3 (3). 2. The interpretative documents shall: (a) give concrete form to the essential requirements laid down in Article 3 and in Annex I by harmonizing the terminology and the technical bases and indicating classes or levels for each requirement where necessary and where the state of scientific and technical knowledge so permits; (b) indicate methods of correlating these classes or levels of requirement with the technical specifications referred to in Article 4, for example, methods of calculation and of proof, technical rules for project design, etc.; (c) serve as a reference for the establishment of harmonized standards and guidelines for European technical approval and for recognition of national technical specifications in accordance with Article 4 (3). 3. The Commission shall publish the interpretative documents in the 'G' series of the Official Official Journal of the European Countries after Soliciting the opinion of the committee referred to in Article 19. CHAPTER V Attestation of conformity Article 13 1. The manufacturer, or his agent established in the Community, shall be responsible for the attestation that products are in conformity with the requirements of a technical specification within the meaning of Article 4. 2. Products that are the subject of an attestation of conformity shall benefit from the presumption of conformity with technical specifications within the meaning of Article 4. Conformity shall be established by means of testing or other evidence on the basis of the technical specifications in accordance with Annex III. 3. The attestation of conformity of a product is dependention: (a) the manufacturer having a factory production control system to ensure that production conforms with the relevant technical specifications; or (b) for particular products indicated in the relevant technical specifications, in addition to a factory production control system, an approved certification body being involved in assessment and surveillance of the production control or of the product itself. 4. The choice of the procedure within the meaning of paragraph 3 for a given product or family of products shall be specified by the Commission, after consultation of the committee referred to in Article 19, according to: (a) the importance of the part played by the product with respect to the essential requirements, in particular those relating to health and safety; (b) the nature of the product; (c) the effect of the variability of the product's characteristics on its serviceability; (d) the susceptibility to defects in the product manufacture; in accordance with the particulars set out in Annex III. In each case, the least onerous possible procedure consistent with safety shall be chosen. The procedure thus determined shall be indicated in the mandates and in the technical specifications or in the publication thereof. 5. In the case of individual (and non-series) production, a declaration of conformity in accordance with Annex III (2) (ii), third possibility, shall suffice, unless otherwise provided by the technical specifications for products which have particularly important implications for health and safety. Article 14 1. In accordance with Annex III, the procedures described shall lead: (a) in the case of Article 13 (3) (a), to the production of a declaration of conformity for a product by the manufacturer, or his agent established in the Community; or (b) in the case of Article 13 (3) (b), to the issue by an approved certification body of a certificate of conformity for a system of production control and surveillance or for the product itself. Detailed rules for the implementation of the procedures of attestation of conformity are given in Annex III. 2. The manufacturer's declaration of conformity or the certificate of conformity shall entitle the manufacturer, or his agent established in the Community, to affix the corresponding EC mark on the product itself, on a label attached to it, on its packaging or on the accompanying commercial documents. The model of the EC mark and the rules for its use in respect of each of the procedures of attestation of conformity are given in Annex III. Article 15 1. Member States shall ensure that the EC mark is correctly used. 2. Where it is established that the EC mark has been affixed to a product which does not satisfy, or no longer satisfies, this Directive, the Member State in which conformity was attested shall ensure that, if necessary, the use of the EC mark is forbidden and unsold products are withdrawn, or marks obliterated, until such time as the product concerned is brought back to conformity The Member State concerned shall immediately inform the other Member States and the Commission, giving all the qualitative and quantitative details necessary to identify the product which does not conform. 3. Member States shall ensure that the affixing to products or their packing of marks which are likely to be confused with the EC mark shall be prohibited. CHAPTER VI Special procedures Article 16 1. In the absence of technical specifications, as defined in Article 4, for any given product, the Member State of destination shall, on request in individual cases, consider the product to be in conformity with the national provisions in force if they have satisfied tests and inspections carried out by an approved body in the producing Member State according to the methods in force in the Member State of destination or recognized as equivalent by that Member State. 2. The producing Member State shall inform the Member State of destination, in accordance with whose provisions the tests and inspections are to be carried out, of the body it intends to approve for this purpose. The Member State of destination and the producing Member State shall provide each other with all necessary information. On conclusion of this exchange of information the producing Member State shall approve the body thus designated. If a Member State has misgivings, it shall substantiate its position and inform the Commission. 3. Member States shall ensure that the designated bodies afford one another all necessary assistance. 4. Where a Member State establishes that an approved body is not carrying out the tests and inspections properly in conformity with its national provisions, it shall notify the Member State in which the body is approved thereof. That Member State shall inform the notifying Member State. within a reasonable time limit of what action has been taken. If the notifying Member State does not consider the action taken to be sufficient, it may prohibit the placing on the market and use of the product in question or make it subject to special conditions. It shall inform the other Member State and the Commission thereof. Article 17 Member States of destination shall attach the same value to reports and attestations of conformity issued in the producing Member State in accordance with the procedure referred to in Article l6, as they do to their own corresponding national documents. CHAPTER VII Approved bodies Article 18 1. Each Member State shall forward to the Commission a list of names and addresses of certification bodies, inspection bodies and testing laboratories which have been designated by that Member State for tasks to be carried out for the purposes of technical approvals, conformity certifications, inspections and tests according to this Directive. 2. Certification bodies, inspection bodies and testing laboratories shall comply with the criteria laid down in Annex IV. 3. Member States shall indicate the products which fall within the competence of the bodies and laboratories referred to in paragraph 1 and the nature of the tasks to be assigned to them. CHAPTER VIII Standing Committee on Construction Article 19 1. A Standing Committee on Construction is hereby set up 2. The committee shall be made up of representatives appointed by the Member States. It shall be chaired by a representative of the Commission. Each Member State shall appoint two representatives. The representatives may be accompanied by experts. 3. The committee shall draw up its own rules of procedure. Article 20 1. The committee referred to in Article 19 may, at the request of its chairman or a Member State, examine any question posed by the implementation and the practical application of this Directive. 2. The provisions necessary for: (a) the establishment of classes of requirements in so far as they are not included in the interpretative documents and the establishment of the procedure for attesting conformity in mandates for standards pursuant to Article 7 (1) and guidelines for approvals pursuant to Article 11 (1); (b) the giving of instructions for the drawing-up of interpretative documents pursuant to Article 12 (1) and decisions on interpretative documents pursuant to Article 12 (3); (c) the recognition of national technical specifications in accordance with Article 4 (3); shall be adopted in accordance with the procedure laid down in paragraphs 3 and 4. 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 committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 4. 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 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. CHAPTER IX Safeguard clause Article 21 1. Where a Member State ascertains that a product declared to be in conformity with the terms of this Directive. does not comply with Articles 2 and 3, it shall take all appropriate measures to withdraw those products from the market, prohibit the placing thereof on the market or restrict free movement thereof. The Member State concerned shall immediately inform the Commission of any such measure, indicating the reasons for its decision, and in particular whether non-conformity is due to: (a) failure to comply with Articles 2 and 3, where the product does not meet the technical specifications referred to in Article 4; (b) incorrect application of the technical specifications referred to in Article 4; (c) shortcomings in the technical specifications referred to in Article 4 themselves 2. The Commission shall carry out a consultation of the parties concerned as soon as possible. Where the Commission finds, after this consultation, that the action is justified, it shall immediately so inform the Member State that took the action as well as the other Member States. 3. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards or technical specifications, the Commission, after consulting the parties concerned, shall bring the matter before the committee referred to in Article 19, as well as the committee set up under Directive 83/189/EEC in the case of shortcomings in a harmonized standard, within two months if the Member State which has taken the measures intends to uphold them, and shall start the procedures referred to in Article 5 (2). 4. The Member State concerned shall take appropriate action against whomsoever made the declaration of conformity and shall inform the Commission and the other Member States thereof. 5. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure. CHAPTER X Final provisions Article 22 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive within 30 months of its notification (6). They shall forthwith inform the Commission thereof. 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 23 At the latest by 31 December 1993, the Commission, in consultation with the committee referred to in Article 19, shall re-examine the practicability of the procedures laid down by this Directive and, where necessary, submit proposals for appropriate amendments. Article 24 This Directive is addressed to the Member States.

31989L0117

1989

COUNCIL DIRECTIVE of 13 February 1989 on the obligations of branches established in a Member State of credit institutions and financial institutions having their head offices outside that Member State regarding the publication of annual accounting documents (89/117/EEC) 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 the establishment of a European internal market presupposes that the branches of credit institutions and financial institutions having their head offices in other Member States should be treated in the same way as branches of credit institutions and financial institutions having their head offices in the same Member State; whereas this means that, with regard to the publication of annual accounting documents, it is sufficient for the branches of such institutions having their head offices in other Member States to publish the annual accounting documents of their institution as a whole; Whereas, as part of a further instrument of coordination of the disclosure requirements in respect of branches, provision is made for certain documents and particulars relating to branches established in a Member State which certain types of companies governed by the law of another Member State, including banks and other financial institutions, have to publish; whereas, as regards disclosure of accounting documents, reference is made to specific provisions to be laid down for banks and other financial institutions; Whereas the present practice of some Member States of requiring the branches of credit institutions and financial institutions having their head offices outside these Member States to publish annual accounts relating to their own activities is no longer justified following the adoption of Council Directive 86/635/EEC of 8 December 1986 on the annual accounts and consolidated accounts of banks and other financial institutions (4); whereas the publication of annual branch accounts cannot in any case provide the public, and in particular creditors, with an adequate view of the financial situation of the undertaking, since part of a whole cannot be viewed in isolation; Whereas, on the other hand, in view of the present level of integration, the need for certain information on the activities of branches established in a Member State by credit institutions and financial institutions having their head offices outside that Member State cannot be disregarded; whereas, nevertheless, he extent of such information should be limited so as to prevent distortions of competition; Whereas, however, this Directive affects only disclosure requirements concerning annual accounts, and does not in any way affect the obligations of branches of credit institutions and financial institutions to provide information pursuant to other requirements, deriving, for example, from social legislation, with regard to employees' rights to information, host countries' rights of supervision over credit institutions or financial institutions and fiscal legislation and also for statistical purposes; Whereas equality of competition means, with regard to the branches of credit institutions and financial institutions having their head offices in non-member countries, that such branches must, on the one hand, in publishing annual accounting documents, adhere to a standard which is the same as, or equivalent to, that of the Community, but, on the other hand, that such branches should not have to publish annual accounts relating to their own activities if they fulfil the abovementioned condition; Whereas the equivalence, required under this Directive, of annual accounting documents of credit institutions and financial institutions having their head offices in non-member countries may lead to problems of assessment; whereas it is therefore necessary for this and other problems in the area covered by the Directive, and in particular in its implementation, to be dealt with by representatives of the Member States and of the Commission jointly in a Contact Committee; whereas, in order to keep the number of such committees within limits, such cooperation should be carried out within the framework of the Committee set up under Article 52 of Council Directive 78/660/EEC of 25 July 1978 on the annual accounts of certain types of companies (5), as last amended by Directive 84/569/EEC (6); whereas, however, where problems relating to credit institutions are to be dealt with, the Committee should be appropriately constituted, Article 1 Scope 1. The coordination measures prescribed by this Directive shall apply to branches established in a Member State by credit institutions and financial institutions within the meaning of Article 2 (1) (a) and (b) of Directive 86/635/EEC having their head offices outside that Member State. Where a credit institution or financial institution has its head office in a non-member country, this Directive shall apply in so far as the credit institution or financial institution has a legal form which is comparable to the legal forms specified in the above-mentioned Article 2 (1) (a) and (b). 2. The third indent of Article 1 of Directive 77/780/EEC (7) shall apply mutatis mutandis to branches of credit institutions and financial institutions covered by this Directive. Article 2 Provisions relating to branches of credit institutions and financial institutions having their head offices in other Member States 1. Member States shall require branches of credit institutions and financial institutions having their head offices in other Member States to publish, in accordance with Article 44 of Directive 86/635/EEC, the credit institution or financial institution documents referred to therein (annual accounts, consolidated accounts, annual report, consolidated annual report, opinions of the person responsible for auditing the annual accounts and consolidated accounts). 2. Such documents must be drawn up and audited in the manner required by the law of the Member State in which the credit institution or financial institution has its head office in accordance with Directive 86/635/EEC. 3. Branches may not be required to publish annual accounts relating to their own activities. 4. Member States may, pending further coordination, require branches to publish the following additional information: — the income and costs of the branch deriving from items 1, 3, 4, 6, 7, 8 and 15 of Article 27 or from items A.4, A.9, B.1 to B.4 and B.7 of Article 28 of Directive 86/635/EEC, — the average number of staff employed by the branch, — the total claims and liabilities attributable to the branch, broken down into those in respect of credit institutions and those in respect of customers, together with the overall amount of such claims and liabilities expressed in the currency of the Member State in which the branch is established, — the total assets and the amounts corresponding to items 2, 3, 4, 5 and 6 of the assets, 1, 2 and 3 of the liabilities and 1 and 2 of the off-balance sheet items defined in Article 4 and parallel Articles of Directive 86/635/EEC, and, in the case of items 2,-5 and 6 of the assets, a breakdown of securities according to whether they have or have not been regarded as financial fixed assets pursuant to Article 35 of Directive 86/635/EEC. Where such information is required, its accuracy and its accordance with the annual accounts must be checked by one or more persons authorized to audit accounts under the law of the Member State in which the branch is established. Article 3 Provisions relating to branches of credit institutions and financial institutions having their head offices in non-members countries 1. Member States shall require branches of credit institutions and financial institutions having their head offices in non-member countries to publish the documents specified in Article 2 (1), drawn up and audited in the manner required by the law of the country of the head office, in accordance with the provisions set out therein. 2. Where such documents are in conformity with, or equivalent to, documents drawn up in accordance with Directive 86/635/EEC and the condition of reciprocity, for Community credit institutions and financial institutions, is fulfilled in the non-member country in which the head office is situated, Article 2 (3) shall apply. 3. In cases other than those referred to in paragraph 2, Member States may require the branches to publish annual accounts relating to their own activities. 4. In the cases specified in paragraphs 2 and 3, Member States may require branches to publish the information referred to in Article 2 (4) and the amount of the endowment capital. 5. Article 9 (1) and (3) of Directive 77/780/EEC shall apply by analogy to branches of credit institutions and financial institutions covered by this Directive. Article 4 Language of publication Member States may require that the documents provided for in this Directive be published in their official national language or languages and that translations thereof be certified. Article 5 Work of the Contact Committee The Contact Committee set up pursuant to Article 52 of Directive 78/660/EEC shall, when constituted appropriately, also: (a) facilitate, without prejudice to Articles 169 and 170 of the Treaty, harmonized application of this Directive through regular meetings dealing, in particular, with practical problems arising in connection with its application, such as assessment of equivalence of documents, and facilitate decisions concerning the comparability and equivalence of the legal forms referred to in Article 1 (1); (b) advise the Commission, if necessary, on additions or amendments to this Directive. Final provisions Article 6 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1991. They shall forthwith inform the Commission thereof. 2. A Member State may provide that the provisions referred to in paragraph 1 shall apply for the first time to annual accounts for the financial year beginning on 1 January 1993 or during the calendar year 1993. 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. Article 7 Five years after the date referred to in Article 6 (2), the Council, acting on a proposal from the Commission, shall examine and, upon a Commission proposal and in cooperation with the European Parliament, if need be, revise Article 2 (4), in the light of the experience acquired in applying this Directive and of the aim of eliminating the additional information referred to in Article 2 (4), taking account of the progress made in striving towards the harmonization of the accounts of banks and other financial institutions. Article 8 This Directive is addressed to the Member States.

31989L0174

1989

Eleventh Commission Directive 89/174/EEC of 21 February 1989 adapting to technical progress Annexes II, III, IV, V, VI and VII to 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 Directive 88/667/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, while 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 Padimate A (INN) used as an ultraviolet filter, benzoyl peroxide, all oestrogen hormones in cosmetic products and certain substances used as hair dyes; Whereas, on the basis of the available information, the field of application of quinolin-8-ol and bis (8-hydroxyquinolinium) sulphate should be extended; Whereas, on the basis of the latest scientific and technical research, the use of glutaraldehyde as a preservative and of 2,4,6 - Trianilino - (p - carbo - 2 - ethylhexyl - 1 - oxi) - 1,3,5 - tria- zine as an ultraviolet filter may be permitted in cosmetic products subject to certain limitations and requirements; Whereas, in order to protect public health, it is advisable to reduce the concentration of a mixture of 5-chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate used as a preservative in cosmetic products; 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. in Annex II: - in No 260, 'with the exception of those listed in Annex V' is deleted, - the following numbers are added: 381. Amyl 4-dimethylaminobenzoate, mixed isomers (Padimate A (INN)) 382. Benzoyl peroxide 383. 2-Amino-4-nitrophenol 384. 2-Amino-5-nitrophenol; 2. in Part 1 of Annex III in the French version, points (a) and (b): (a) under reference No 1, boric aid, 'Mouth-care products' in column c (b) is replaced by 'Oral hygiene products'; (b) under reference No 12, hydrogen peroxide, 'Skin-care preparations' in column c (b) is replaced by 'Skin-hygiene preparations'; (c) under reference No 53, etidronic acid, the words in column f are deleted; 3. in Part 2 of Annex III: the words in the column 'Other limitations and requirements' are deleted from reference Nos 12 700, 15 800, 20 470, 42 170, 45 190 and 47 000; 4. in Part 1 of Annex IV a reference No 1 is added: 1.2.3.4.5.6.7 // // // // // // // // a // b // c // d // e // f // g // // // // // // // // '1 // Quinolin-8-ol and bis (8-hydroxy-quinolium) sulphate // (a) Preparations for skin hygiene not rinsed off after use // 0,02 % calculated as base // // (a) (b) (c) Contains quinolin-8-ol // 31. 12. 1990' // // // (b) Foot hygiene preparations not rinsed off after use // 0,04 % calculated as base // // // // // // (c) Mouth hygiene products // 0,01 % calculated as base // // // // // // // // // // 5. in Part 2 of Annex IV: (a) the numbers 15 800, 19 120, 20 470, 21 115, 42 170, 45 190, 47 000, 73 905 and 75 660 are deleted; (b) '31. 12. 1988' in the column 'Allowed until' is replaced by '31. 12. 1989' for the following numbers: 13 065, 21 110, 26 100, 42 045, 42 535, 44 045, 61 554, 73 900 and 74 180; (c) for the colouring agent CI 42 535 'solely in hair preparations at a maximum concentration of 100 ppm' is added to the 'other limits and requirements column'; 6. in Annex V, item (a) of reference No 3, oestrone, oestradiol and its esters, oestriol and its esters, is deleted; 7. in Annex VI, Part 1: (a) in the French version: under reference No 5, formaldehyde and paraformaldehyde, the words in column c are replaced by the following: '0,2 % (except for oral hygiene) 0,1 % (for oral hygiene) concentrations expressed as free formaldehyde'; (b) the maximum authorized concentration in column c for reference No 39, 5-chloro-2-methyl-isothiazol-3(2H)one and 2-methyl-isothiazol-3(2H)-one with magnesium chloride and magnesium nitrate, is replaced by 0,0015 %; (c) under reference No 20, bromo-5-nitro-5-diox- ane, 1,3, 'see Annex VI, Part 2, reference No 7' in column d is deleted; 8. in Part 2 of Annex VI: (a) the following reference number is added: 1.2.3.4.5.6 // // // // // // // a // b // c // d // e // f // // // // // // // '26 // Glutaraldehyde // 0,1 % // Prohibited in aerosols (sprays) // Contains glutaraldehyde where the glutaraldehyde concentration in the finished product exceeds 0,05 % // 31. 12. 1991' // // // // // // (b) the following reference numbers are deleted: - 1. Boric acid (+) - 3. Dibromopropamidine (INN) and its salts (including isethionate) - 5. 3 - Heptyl - 2 - (3 - heptyl - 4 - methyl - 4 - thiazo- lin - 2 - ylidene methyl) - 4 - methyl - thiazo- linium iodide - 19. 4-Hydroxybenzoic acid benzyl ester - 25. 1,3,5-Tris (2-hydroxyethyl)hexahydro-1,3,5- triasine, (c) '31. 12. 1988' in column f is replaced by '31. 12. 1989' for the following reference numbers: - 4. Alkyl(C12-C22) trimethyl-ammonium bro- mide and chloride (including Cetrimonium bromide (INN) (+)) - 15. Benzethonium chloride (INN) (+) - 16. Benzalkonium chloride (INN), bromide and saccharinate (+) - 20. Hexamidine (INN) and its salts (including isethionate and 4-hydroxybenzoate) (+); 9. in Part 2 of Annex VII the following reference numbers are deleted: - 3. Padimate A (INN) - 7. 3,3,5 - Trimethylcyclohexyl - 2 - acetamidoben- zoate - 8. Potassium cinnamate - 9. 4-Methoxycinnamic acid salts (potassium, sodium and diethanolamine salts) - 10. Propyl 4-methoxycinnamate - 11. Salicylic acid salts (potassium, sodium and triethanolamine salts) - 14. Cinoxate (INN) - 15. 3,4-Dihydroxy-5-(trihydroxybenzoyloxy) ben- zoic acid, trioleate - 18. 2-Ethylhexyl 2-(4-phenylbenzoyl)-benzoate - 19. 5-Methyl-2-phenylbenzoxazole - 20. Sodium 3,4-dimethoxyphenylglyoxylate - 21. 1,3-bis(4-methoxyphenyl) propane-1,3-dione - 22. 5 - (3,3 - Dimethyl - 8,9,10 - trinorborn - 2 - ylidene) pent-3-en-2-one - 23. alpha - (2 - Oxoborn - 3 - ylidene) - p - xylene - 2 - sul- phonic acid - 27. alpha-cyano-4-methoxy cinnamic acid and its hexyl ester - 30. Cyclohexyl 4-methoxycinnamate; 10. Part 2 of Annex VII is replaced by the text in the Annex to this Directive. Article 2 1. Without prejudice to the allowed dates referred to in Article 1 (4), (5), (8) and (10), Member States shall take the necessary measures to ensure that, with effect from 1 January 1990 for substances referred to in Article 1 (1) and with effect from 1 January 1991 for substances referred to in Article 1 (2), (4), (5), (7), (8) and (10), neither manufacturers nor importers established in the Community place on the market products which do not meet the requirements of this Directive. 2. Member States shall take the necessary measures to

31989L0178

1989

Commission Directive 89/178/EEC of 22 February 1989 adapting 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 point 2.1 of Annex II to Directive 88/379/EEC contains special provisions on the labelling of paints and varnishes containing lead; whereas these provisions are based on lead content expressed as a percentage of the total weight of the preparation in question and the lead content must be revised, pursuant to Commission Directive 86/508/EEC (2), by 31 December 1988 at the latest; Whereas preparations, on sale to the general public containing active chlorine or constituents capable of giving off active chlorine can, under particular circumstances, represent a risk for uninformed users; whereas users should be warned of this risk; Whereas preparations containing cadmium (alloys) used for soldering and brazing are dangerous only during use; whereas in those circumstances users should be provided through labelling with information to enable them to use such products correctly and without danger; Whereas the special labelling provisions applicable to certain preparations set out in Annex II to Directive 88/379/EEC should therefore be revised and supplemented; 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 Directive 88/379/EEC is hereby amended as follows: 1. '0,25 %' in point 2.1 of Annex II is replaced by '0,15 %'; 2. the following points are added to Annex II: '7. PREPARATIONS SOLD TO THE GENERAL PUBLIC WHICH CONTAIN ACTIVE CHLORINE The packaging of preparations containing more than 1 % of active chlorine must bear the following particular inscriptions: "Warning! Do not use together with other products. May release dangerous gases (chlorine)". 8. PREPARATIONS CONTAINING CADMIUM (ALLOYS) AND INTENDED TO BE USED FOR BRAZING OR SOLDERING The packaging of the abovementioned preparations must bear the following inscription printed in clearly legible and indelible characters: "Warning! Contains cadmium. Dangerous fumes are formed during use See information supplied by the manufacturer Comply with the safety instructions".'

31989L0235

1989

Council Directive 89/235/EEC of 13 March 1989 amending Directive 78/1015/EEC on the approximation of the laws of the Member States on the permissible sound level and exhaust systems of motorcycles 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 78/1015/EEC (4), as last amended by Directive 87/56/EEC (5), lays down limits for the sound level of motorcycles and provisions governing exhaust systems fitted as original equipment to motorcycles; Whereas replacement exhaust systems very frequently differ from original equipment; whereas this situation therefore has, among other things, adverse effects on the sound emissions of motorcycles; whereas an EEC type-approval procedure for such replacement devices, making it possible to establish that a type of device meets the technical requirements and checks laid down at Community level, is likely to be an adequate means of reducing the sound level of motorcycles in use and of affording the population additional protection against noise nuisances caused by such vehicles; Whereas, to that end, Directive 78/1015/EEC should be amended by including provisions on exhaust systems as separate technical units to be marketed and used as replacement parts, so that such equipment may be regulated by Community requirements for ensuring effective protection against noise nuisances, Article 1 Directive 78/1015/EEC is hereby amended as follows: 1. Article 2 is replaced by the following: ´Article 2 For the purposes of this Directive: (a) ´´national type-approval'' means the administrative procedure known as: - ´´agréation par type'' and ´´aanneming'', in Belgian law, - ´´standardtypegodkendelse'', in Danish law, - ´´allgemeine Betriebserlaubnis'', in German law, - ´´egkrioh tzpoz'' in Greek law, - ´´homologación de tipo'', in Spanish law, - ´´réception par type'', in French law, - ´´type-approval'', in Irish law, - ´´omologazione'' or ´´approvazione del tipo'', in Italian law, - ´´agréation'', in Luxembourg law, - ´´typegoedkeuring'', in Dutch law, - ´´aprovaçao de marca e modelo'', in Portuguese law, - ´´type-approval'', in United Kingdom law; (b) ´´EEC type-approval of replacement exhaust systems or components thereof as separate technical units'' means the measure whereby a Member State established that a type of replacement exhaust system or type of component thereof meets the technical requirements and successfully undergoes the checks set out in Annex II.' 2. In the second subparagraph of Article 3 (1), the reference to Annex II is replaced by a reference to Annex III. 3. The following Article is inserted: ´Article 6a Articles 3 to 6 shall apply mutatis mutandis to the EEC type-approval of replacement exhaust systems or components thereof as separate technical units as defined in Article 2 (b). In such cases, the model certificate referred to in Article 3 shall be replaced by the model EEC type-approval certificate set out in Annex IV and the modification of one of the components or characteristics mentioned in Annex I, section 1.1, as referred to in Article 6, shall be replaced by the modification of one of the characteristics referred to in Annex I, section 1.3.' 4. The Annexes are amended and supplemented in accordance with the Annex hereto. Article 2 1. As from 1 October 1989: (a) no Member State may, on grounds concerning the permissible sound level and the original equipment exhaust system, refuse national type-approval for a type of motorcycle or EEC type-approval or national type-approval for a type of replacement exhaust system or type of component of such a system where such systems or components are regarded as separate technical units: - if the motorcycle complies with the requirements of Annex I to Directive 78/1015/EEC, as amended by this Directive, regarding the sound level and original equipment exhaust system, - if the replacement exhaust system or components thereof as separate technical units comply with the requirements of Annex II to Directive 78/1015/EEC, as amended by this Directive; (b) no Member State may, on grounds concerning the permissible sound level and the original equipment exhaust system, refuse or prohibit the sale, registration, putting into service or use of motorcycles, or refuse or prohibit the placing on the market or use of replacement exhaust systems or components thereof as separate technical units: - if the motorcycles comply with the requirements of Annex I to Directive 78/1015/EEC, as amended by this Directive, regarding the sound level and original equipment exhaust system, - if the replacement exhaust systems or components thereof as separate technical units comply with the requirements of Annex II to Directive 78/1015/EEC, as amended by this Directive. 2. As from 1 October 1990: (a) Member States may no longer issue the certificate provided for in Article 3 (1) of Directive 78/1015/EEC for a type of motorcycle regarding the permissible sound level and original equipment exhaust system, nor the certificate provided for mutatis mutandis in that same paragraph of the Directive concerned, for a type of replacement exhaust system or component thereof as separate technical units, if they do not comply with the provisions of Directive 78/1015/EEC, as amended by this Directive; (b) - Member States may, on grounds concerning the permissible sound level and original equipment exhaust system, refuse national type-approval for a type of motorcycle or type of replacement exhaust system or type of component of such a system as separate technical units, if they do not comply with the provisions of Directive 78/1015/EEC, as amended by this Directive, - Member States may, on grounds concerning the permissible sound level and the original equipment exhaust system, refuse or prohibit the sale, registration, putting into service or use of motorcycles, or the placing on the market and use of replacement exhaust systems or components thereof as separate technical units, if they do not comply with the provisions of Directive 78/1015/EEC, as amended by this Directive. 3. As from 1 October 1991, Member States may prohibit the initial putting into service of motorcycles the sound level and original equipment exhaust system of which do not comply with the provisions of Annex I to Directive 78/1015/EEC, as amended by this Directive. Article 3 By 1 October 1989, 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 from 1 October 1989. Article 4 This Directive is addressed to the Member States.

31989L0277

1989

Commission Directive 89/277/EEC of 28 March 1989 adapting to technical progress Council Directive 76/759/EEC on the approximation of the laws of the Member States relating to direction indicator lamps for motor vehicles and their trailers Having regard to the Treaty establishing the European Economic Community, Having regard to 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 (1), as last amended by Directive 87/403/EEC (2), and in particular Article 11 thereof, Having regard to Council Directive 76/759/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to direction indicator lamps for motor vehicles and their trailers (3), as last amended by Directive 87/354/EEC (4), and in particular Article 10 thereof, Whereas, in the light of experience and in view of the current state of the art, it is now possible to make certain requirements more complete and better adapted to actual traffic conditions thus improving the safety offered to vehicle occupants and other road users; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of Directives on the Removal of Technical Barriers to Trade in the Motor Vehicles Sector; Article 1 The Annexes to Directive 76/759/EEC are hereby amended in accordance with the Annex to this Directive. Article 2 1. With effect from 31 March 1989, no Member State may: (a) - refuse, in respect of a type of 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 entry into service of vehicles, on grounds relating to the direction indicator lamps if the latter comply with the provisions of this Directive; (b) - refuse to grant EEC component type approval or national component type approval in respect of the said direction indicator lamps if they comply with the provisions of this Directive, or - prohibit the placing on the market of direction indicator lamps if the latter bear the EEC component type-approval mark issued in pursuance of the provisions of this Directive. 2. With effect from 1 October 1991, Member States: (a) - shall no longer issue the document referred to in the last indent of Article 10 (1) of Directive 70/156/EEC in respect of a type of vehicle in which the direction indicator lamps do not comply with the provisions of this Directive, - may refuse to grant national type approval in respect of a type of vehicle in which the said direction indicator lamps do not comply with the provisions of this Directive; (b) - shall no longer grant EEC component type approval in respect of direction indicator lamps if the latter do not comply with the provisions of this Directive, - may refuse to grant national component type approval in respect of the said direction indicator lamps if they do not comply with the provisions of this Directive. Nevertheless, this date is postponed to 1 October 1993 in the case of the EEC component type approval of category 5 direction indicator lamps. 3. With effect from 1 October 1995, Member States may prohibit the entry into service of vehicles in which the direction indicator lamps do not comply with the provisions of this Directive, as well as the placing on the market of direction indicator lamps that do not bear the type-approval mark issued in pursuance of the provisions of this Directive. 4. Notwithstanding paragraph (2) (b), Member States shall continue to recognize EEC component type approval granted for direction indicator lamps in pursuance of Directive 76/759/EEC in the case of devices intended to be mounted on vehicles already in circulation, and may also grant EEC component type approval for direction indicator lamps in pursuance of Directive 76/759/EEC provided that such devices are intended to be used as replacement parts for vehicles in circulation and it is not technically possible for the said devices to comply with the provisions of this Directive. Article 3 The provisions of Article 2 shall not apply if they conflict with the provisions of Article 2 (2), (3) and (4) of Commission Directive 89/278/EEC of 28 March 1989, adapting to technical progress Council Directive 76/756/EEC on the approximation of the laws of the Member States relating to the installation of lighting and light-signalling devices on motor vehicles and their trailers (1). Article 4 Member States shall bring into force the provisions necessary to comply with this Directive not later than 30 September 1989. They shall forthwith inform the Commission thereof. Article 5 This Directive is addressed to the Member States.

31989L0278

1989

Commission Directive 89/278/EEC of 28 March 1989 adapting to technical progress Council Directive 76/756/EEC on the approximation of the laws of the Member States relating to the installation of lighting and light-signalling devices on motor vehicles and their trailers Having regard to the Treaty establishing the European Economic Community, Having regard to 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 (1), as last amended by Directive 87/403/EEC (2), and in particular Article 11 thereof, Having regard to Council Directive 76/756/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to the installation of lighting and light-signalling devices on motor-vehicles and their trailers (3), as last amended by Directive 84/8/EEC (4), and in particular Article 4 thereof, Whereas, in the light of experience and in view of the current state of the art, certain requirements may now be supplemented and brought more into line with real traffic conditions, while thus improving the safety of vehicle occupants and other road users; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of Directives on the Removal of Technical Barriers to Trade in the Motor Vehicles Sector, Article 1 Annex I to Directive 75/756/EEC is hereby amended in accordance with the Annex to this Directive. Article 2 1. With effect from 31 March 1989, no Member State may: - refuse, in respect of a type of 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 entry into service of vehicles on grounds relating to the installation on the vehicles of the lighting and light-signalling devices, whether mandatory or optional, listed in 1.5.9 to 1.5.22 of Annex I to Directive 76/756/EEC, if the installation of the said lighting and light-signalling devices on the type of vehicle or vehicles in question complies with the provisions of this Directive. 2. With effect from 1 October 1989, Member States: - shall no longer issue the document referred to in the last indent of Article 10 (1) of Directive 70/156/EEC in respect of a type of vehicle if the installation of the said lighting and light-signalling devices does not comply with the provisions of this Directive, except in respect of the category I a and 1 b front direction indicator lamps described in Annex I to Directive 76/756/EEC, item 4.5.3, - may refuse to grant national type approval in respect of a type of vehicle if the installation of the said lighting and light-signalling devices does not comply with the provisions of this Directive, except in respect of the category 1 a and 1 b front direction indicator lamps described in Annex I to Directive 76/756/EEC, item 4.5.3. 3. With effect from 1 April 1991 Member States may refuse the national type approval of a type of vehicle and may no longer issue the document provided for in Article 10 (1), final indent, of Directive 70/156/EEC for a type of vehicle if the installation of said lighting and light-signalling devices does not comply with the provisions of this Directive, except in respect of the provisions relating to the category 1 a and 1 b front direction indicator lamps described in Annex I to Directive 76/756/EEC, item 4.5.3, for types of vehicle, the type approval of which is prompted neither by a new design nor by a change in design and/or body shape which could effect the dimensions of those front direction indicator lamps and their position in relation to the front dipped-beam headlamps and fog lamps. 4. With effect from 1 October 1993, Member States may prohibit the entry into service of vehicles if the installation of the lighting and light-signalling devices does not comply with the provisions of this Directive, except in respect of the category 1 a and 1 b front direction indicator lamps described in Annex I to Directive 76/756/EEC, item 4.5.3. Article 3 Member States shall bring into force the provisions necessary to comply with this Directive not later than 30 September 1989. They shall forthwith inform the Commission thereof. Article 4 This Directive is addressed to the Member States.

31989L0297

1989

COUNCIL DIRECTIVE of 13 April 1989 on the approximation of the laws of the Member States relating to the lateral protection (side guards) of certain motor vehicles and their trailers (89/297/EEC) 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 vehicles must satisfy pursuant to national laws relate inter alia to the side guards of motor vehicles and their trailers; 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, in particular, to allow 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, in order to increase road safety, it is necessary to fit side guards to all vehicles in higher weight categories in order to offer unprotected road users (pedestrians, cyclists, motorcyclists) efficient protection against the risk of falling under the sides of such vehicles; Whereas, for practical reasons, it is felt necessary to provide for different periods of application for new type-approvals and for all new vehicles; Whereas the approximation of the national laws relating to motor vehicles includes the mutual recognition by the Member States of the checks carried out by each of them on the basis of common requirements, Article 1 For the purposes of this Directive, ‘vehicle’ means any motor vehicle in categories N2 and N3 and trailer in categories 03 and 04, as defined in Annex 1 to Directive 70/156/EEC, designed for use on the road, with or without bodywork and with a maximum design speed exceeding 25 km/h. Article 2 1. No Member State may, on grounds relating to lateral protection, refuse to grant EEC type-approval or national type-approval in respect of a vehicle if such vehicle meets the requirements set out in the Annex. 2. No Member State may, on grounds relating to lateral protection, refuse or prohibit the sale, registration, entry into service or use of a vehicle if such a vehicle meets the requirements set out in the Annex. Article 3 A Member State which has granted EEC type-approval shall take the measures necessary to ensure that it is informed of any modification to a part or characteristic referred to in the Annex. The competent authorities of that Member State shall determine whether fresh tests should be carried out on the modified type and a fresh report drawn up. Where such tests reveal that the requirements of this Directive have not been complied with, the modification shall not be authorized. Article 4 1. With effect from 1 June 1990 Member States: — may no longer issue the document provided for in Article 10 (1), third indent, of Directive 70/156/EEC in respect of a type of vehicle of which the lateral protection devices do not meet the requirements of this Directive, — may refuse to grant national type-approval in respect of a type of vehicle of which the lateral protection devices do not comply with the provisions of this Directive. 2. With effect from 1 May 1991 Member States may prohibit the first entry into service of vehicles of which the lateral protection devices do not comply with the provisions of this Directive. Article 5 The amendments necessary in order to adapt the requirements of the Annex so as to take account of technical progress shall be adopted in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC. Article 6 1. Member States shall bring into force the provisions necessary in order to comply with this Directive by 30 October 1989. They shall forthwith inform the Commission thereof. 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 7 This Directive is addressed to the Member States.

31989L0284

1989

Council Directive 89/284/EEC of 13 April 1989 supplementing and amending Directive 76/116/EEC in respect of the calcium, magnesium, sodium and sulphur content of fertilizers 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 need to be adopted for the progressive completion of the internal market by 31 December 1992; whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is guaranteed; Whereas Council Directive 76/116/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to fertilizers (4), as last amended by Directive 88/183/EEC (5), laid down rules for the marketing of solid EEC fertilizers; whereas it has proved necessary to extend the said Directive to include the calcium, magnesium, sodium and sulphur contents of such fertilizers; Whereas Directive 76/116/EEC may henceforth be applicable to fertilizers containing only calcium, magnesium and sulphur, Article 1 A declaration of the magnesium, sodium and sulphur content of the EEC fertilizers listed in Annex I to Directive 76/116/EEC may be made provided that these elements are present in at least the minimum quantities specified in Article 2 of this Directive and that the EEC fertilizers continue to satisfy the requirements of Annex I to Directive 76/116/EEC. In such cases, the marking specified in point (b) of Article 6 of this Directive shall be added to the type designation. Article 2 A declaration of the magnesium, sodium and sulphur content of the EEC fertilizers referred to in Article 1 may be made only if they contain not less than: - 2 % of magnesium oxide (MgO), i.e. 1,2 % Mg, - 3 % of sodium oxide (Na2O), i.e. 2,2 % Na, - 5 % of sulphur trioxide (SO3), i.e. 2 % S. Article 3 1. Within the meaning of this Directive, a declaration of the calcium content considered to be a nutrient shall be made, without prejudice to paragraph 2, only for fertilizers of types 1 and 2 as listed in Annex I. Member States may stipulate that the calcium content of fertilizers marketed in their territories be expressed in the oxide form (CaO), in the elemental form (Ca), or in both of these forms. The following formula shall be used to convert the calcium oxide content into a calcium content: calcium (Ca) = calcium oxide (CaO) × 0,715 2. The soluble calcium content of the liquid fertilizers referred to in Part C of Annex I to Directive 76/116/EEC, which are intended for foliage spraying, may be stipulated when the content reaches a minimum of 8 % calcium oxide (= 5,7 % Ca). Article 4 Fertilizers meeting the provisions of this Directive and the Annexes thereto may be marked 'EEC FERTILIZER'. Article 5 Member States may stipulate that the magnesium, sodium and sulphur contents of fertilizers marketed in their territories shall be expressed: - in the oxide form (MgO, Na2O, SO3), - or in the elemental form (Mg, Na, S), - or in both of these forms. The following formulae shall be used to convert the sodium oxide and sulphur trioxide contents into sodium and sulphur contents: - sodium (Na) = sodium oxide (Na2O) × 0,742, - sulphur (S) = sulphur trioxide (SO3) × 0,400. If the oxide content is calculated, the figure declared shall be rounded to the nearest decimal place. Article 6 Compulsory marking for identification purposes: (a) 'EEC FERTILIZER' in capital letters; (b) the designation of the type of fertilizer: - either in accordance with Annex I to Directive 76/116/EEC, with the designation of the type being followed by 'containing . . .' and the names or chemical symbols of the elements referred to in this Directive which the fertilizer contains. The figures indicating the contents of the elements referred to in Directive 76/116/EEC may be followed by figures in brackets for the elements referred to in Annex I to this Directive, - or in accordance with Annex I to this Directive; (c) the guaranteed content in respect of each nutrient and the guaranteed content expressed as forms and/or solubilities, where these are apecified in the Annexes to the Directives on fertilizers. The nutrient content of staight and compound fertilizers shall be given as a percentage by weight in whole numbers, or where necessary, to one decimal place. If a fertilizer contains several declarable elements, their contents shall be indicated in the following order: N, P2O5 and/or P, K2O and/or K, CaO or Ca, MgO and/or Mg, Na2O and/or Na, SO3 and/or S. The forms and solubilities of the nutrients shall also be expressed as a percentage by weight of fertilizer, except where Annex I to Directive 76/116/EEC explicitly provides that this content shall be otherwise expressed. Nutrients shall be indicated both in words and by appropriate chemical symbols, e.g. nitrogen (N), phosphorus (P), phosphorus pentoxide (P2O5), potassium (K), potassium oxide (K2O), magnesium (Mg), magnesium oxide (MgO), sodium (Na), sodium oxide (Na2O), sulphur (S), sulphur trioxide (SO3), calcium (Ca) and calcium oxide (CaO). Article 7 The declaration of the magnesium, sodium and sulphur content of the fertilizers referred to in Article 1 shall be expressed in one of the following ways: - the total content expressed as a percentage of the fertilizer by weight, - where an element is totally soluble in water, only the content soluble in water shall be declared, - the total content and the content soluble in water, expressed as a percentage of the fertilizer by weight when the soluble content is at least a quarter of the total content. The contents shall be determined under the conditions specified in the analytical methods referred to in Article 8 of Directive 76/116/EEC. Article 8 The tolerances allowed in respect of the declared calcium, magnesium, sodium and sulphur contents shall be a quarter of the declared contents of these elements up to a maximum of 0,9 % in absolute terms for CaO, MgO, Na2O and SO3, i.e. 0,64 for Ca, 0,55 for Mg, 0,67 for Na and 0,36 for S. Article 9 Annex I to Directive 76/116/EEC shall be amended as follows: 1. the EEC fertilizer kieserite with potassium sulphate mentioned in Annex II to this Directive shall be added to Part A - Straight fertilizers, III. Potassic fertilizers - as No 7; 2. the EEC fertilizer calcium nitrate solution, mentioned in Annex II to this Directive, shall be added to Part C - Liquid fertilizers 1 - Straight fertilizers - as No 3, for liquid fertilizers. Article 10 1. Member States shall adopt the measures necessary to comply with this Directive within 12 months of its notification (1). They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive. Article 11 This Directive is addressed to the Member States.

31989L0298

1989

Council Directive 89/298/EEC of 17 April 1989 coordinating the requirements for the drawing-up, scrutiny and distribution of the prospectus to be published when transferable securities are offered to the public 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 investment in transferable securities, like any other form of investment, involves risks; whereas the protection of investors requires that they be put in a position to make a correct assessment of such risks so as to be able to take investment decisions in full knowledge of the facts; Whereas the provision of full, appropriate information Whereas the provision of full, appropriate information concerning transferable securities and the issuers of such securities promotes the protection of investors; Whereas, moreover, such information is an effective means of increasing confidence in transferable securities and thus contributes to the proper functioning and development of transferable securities markets; Whereas a genuine Community information policy relating to transferable securities should therefore be introduced; whereas, by virtue of the safeguards that it offers investors and its impact on the proper functioning of transferable securities markets, such an information policy is capable of promoting the interpenetration of national transferable securities markets and thus encouraging the creation of a genuine European capital market; Whereas Council Directive 80/390/EEC of 17 March 1980 Whereas Council Directive 80/390/EEC of 17 March 1980 coordinating the requirements for the drawing-up, scrutiny and distribution of the listing particulars to be published for the admission of securities to official stock exchange listing (4), as last amended by Directive 87/345/EEC (5), represents an important step in the implementation of such a Community information policy; whereas that Directive coordinates the information to be published when securities are admitted to stock exchange listing concerning the nature of the securities offered and the issuers of such securities, so of the securities offered and the issuers of such securities, so as to enable investors to make an informed assessment of the assets and liabilities, financial position, profits and losses and prospects of issuers and of the rights attaching to such securities; Whereas such an information policy also requires that when transferable securities are offered to the public for the first time in a Member State, whether by, or on behalf of the issuer or a third party, whether or not they are subsequently listed, a prospectus containing information of this nature must be made available to investors; whereas it is also necessary to coordinate the contents of that prospectus in order to achieve equivalence of the minimum safeguards afforded to investors in the various Member States; Whereas, so far, it has proved impossible to furnish a common definition of the term ´public offer' and all its constituent parts; Whereas, in cases where a public offer is of transferable securities which are to be admitted to official listing on a stock exchange, information similar to that required by Directive 80/390/EEC, whilst being adapted to the circumstances of the public offer, must be supplied; whereas, for public offers of transferable securities that are not to be admitted to official stock exchange listing, less detailed information can be required so as not to burden small and medium-sized issuers unduly; whereas, for public offers of transferable securities that are to be admitted to official stock exchange listing, the degree of coordination achieved is such that a prospectus approved by the competent authorities of a Member State can be used for public offers of the same securities in another Member State on the basis of mutual recognition; whereas mutual recognition should also apply where public offer prospectuses comply with the basic standards laid down in Directive 80/390/EEC and are approved by the competent authorities even in the absence of a request for admission to official stock exchange listing; Whereas in order to ensure that the purposes of this Directive will be fully realized it is necessary to include within the scope of this Directive transferable securities issued by companies or firms governed by the laws of third countries; Whereas it is advisable to provide for the extension, by means of agreements to be concluded by the Community with third countries, of the recognition of prospectuses from those countries on a reciprocal basis: SECTION I General provisions Article 1 1. This Directive shall apply to transferable securities which are offered to the public for the first time in a Member State provided that these securities are not already listed on a stock exchange situated or operating in that Member State. 2. Where an offer to the public is for part only of the transferable securities from a single issue, the Member States need not require that another prospectus be published if the other part is subsequently offered to the public. Article 2 This Directive shall not apply: 1. to the following types of offer: (a) where transferable securities are offered to persons in the context of their trades, professions or occupations, and/or (b) where transferable securities are offered to a restricted circle of persons, and/or (c) where the selling price of all the transferable securities offered does not exceed ECU 40 000, and/or (d) where the transferable securities offered can be acquired only for a consideration of at least ECU 40 000 per investor; 2. to transferable securities of the following types: (a) to transferable securities offered in individual denominations of at least ECU 40 000; (b) to units issued by collective investment undertakings other than of the closed-end type; (c) to transferable securities issued by a State or by one of a State's regional or local authorities or by public international bodies of which one or more Member States are members; (d) to transferable securities offered in connection with a take-over bid; (e) to transferable securities offered in connection with a merger; (f) to shares allotted free of charge to the holders of shares; (g) to shares or transferable securities equivalent to shares offered in exchange for shares in the same company if the offer of such new securities does not involve any overall increase in the company's issued shares capital; (h) to transferable securities offered by their employer or by an affiliated undertaking to or for the benefit of serving or former employees; (i) to transferable securities resulting from the conversion of convertible debt securities or from the exercise of the rights conferred by warrants or to shares offered in exchange for exchangeable debt securities, provided that a public offer prospectus or listing particulars relating to those convertible or exchangeable debt securities or those warrants were published in the same Member State; (j) to transferable securities issued, with a view to their obtaining the means necessary to achieve their disinterested objectives, by associations with legal status or non-profit-making bodies, recognized by the State; (k) to shares or transferable securities equivalent to shares, ownership of which entitles the holder to avail himself of the services rendered by bodies such as ´building societies', ´Crédits populaires', ´Genossenschaftsbanken', or ´Industrial and Provident Societies', or to become a member of such a body; (l) to Euro-securities which are not the subject of a generalized campaign of advertising or canvassing. Article 3 For the purposes of this Directive: (a) ´collective investment undertakings other than of the closed-end type' shall mean unit trusts and investment companies: - the object of which is the collective investment of capital provided by the public, and which operate on the principle of risk spreading, and - the units of which are, at the holders' request, repurchased or redeemed, directly or indirectly, out of the assets of those undertakings. Action taken by such undertakings to ensure that the stock exchange value of their units does not significantly vary from their net asset value shall be regarded as equivalent to such repurchase or redemption; (b) ´units of a collective investment undertaking' shall mean transferable securities issued by a collective investment undertaking representing the rights of the participants in such an undertaking over its assets; (c) ´issuers' shall mean companies and other legal persons and any undertakings the transferable securities of which are offered to the public; (d) ´credit institution' shall mean an undertaking the business of which is to receive deposits or other repayable funds from the public and to grant credits for its own account, including credit institutions such as referred to in Article 2 of Directive 77/780/EEC (6), as last amended by Directive 86/524/EEC (7); (e) ´transferable securities' shall mean shares in companies and other transferable securities equivalent to shares in companies, debt securities having a maturity of at least one year and other transferable securities equivalent to debt securities, and any other transferable security giving the right to acquire any such transferable securities by subscription or exchange; (f) ´Euro-securities' shall mean transferable securities which: - are to be underwritten and distributed by a syndicate at least two of the members of which have their registered offices in different States, and - are offered on a significant scale in one or more States other than that of the issuer's registered office, and - may be subscribed for or initially acquired only through a credit institution or other financial institution. Article 4 Member States shall ensure that any offer of transferable securities to the public within their territories is subject to the publication of a prospectus by the person making the offer. Article 5 Member States may provide for partial or complete exemption from the obligation to publish a prospectus where the transferable securities being offered to the public are: (a) debt securities or other transferable securities equivalent to debt securities issued in a continuous or repeated manner by credit institutions or other financial institutions equivalent to credit institutions which regularly publish their annual accounts and which, within the Community, are set up or governed by a special law or pursuant to such a law, or are subject to public supervision intended to protect savings; (b) debt securities or other transferable securities equivalent to debt securities issued by companies and other legal persons which are nationals of a Member State and which: - in carrying on their business, benefit from State monopolies, and - are set up or governed by a special law or pursuant to such a law or whose borrowings are unconditionally and irrevocably guaranteed by a Member State or one of a Member State's regional or local authorities; (c) debt securities issued by legal persons, other than companies, which are nationals of a Member State, and - were set up by special law, and - whose activities are governed by that law and consist solely in i(i) raising funds under state control through the issue of debt securities; and (ii) financing production by means of the resources which they have raised and resources provided by a Member State and/or acquiring a holding in such production, and - the debt securities of which are, for the purposes of admission to official listing, considered by national law as debt securities issued or guaranteed by the State. Article 6 If a full prospectus has been published in a Member State within the previous 12 months, the following prospectus drawn up by the same issuer in the same State, but relating to different transferable securities, may indicate only those changes likely to influence the value of the securities which have occurred since publication of the full prospectus. However, that prospectus may be made available only accompanied by the full prospectus to which it relates or by a reference thereto. SECTION II Contents and arrangements for the scrutiny and distribution of the prospectus for transferable securities for which admission to official stock exchange listing is sought Article 7 Where a public offer relates to transferable securities which at the time of the offer are the subject of an application for admission to official listing on a stock exchange situated or operating within the same Member State, the contents of the prospectus and the procedures for scrutinizing and distributing it shall, subject to adaptations appropriate to the circumstances of a public offer, be determined in accordance with Directive 80/390/EEC. Article 8 1. Where a public offer is made in one Member State and admission is sought to official listing on a stock exchange situated in another Member State, the person making the public offer shall have the possibility in the Member State in which the public offer is to be made of drawing up a prospectus the contents and procedures for scrutiny and distribution of which shall, subject to adaptations appropriate to the circumstances of a public offer, be determined in accordance with Directive 80/390/EEC. 2. Paragraph 1 shall apply only in those Member States which in general provide for the prior scrutiny of public offer prospectuses. Article 9 A prospectus must be published or made available to the public not later than the time when an offer is made to the public. Article 10 1. Where a prospectus in accordance with Article 7 or 8 is or is to be published, the advertisements, notices, posters and documents announcing the public offer must be communicated in advance to the competent authorities. The aforementioned documents must mention that there is a prospectus and state where the prospectus is published. 2. If the Member States authorize the distribution of the documents referred to in paragraph 1 before the prospectus is available, those documents must state that a prospectus will be published and indicate where members of the public will be able to obtain it. 3. The prospectus must be published either: - by insertion in one or more newspapers circulated throughout the Member State in which the public offer is made, or - in the form of a brochure to be made available, free of charge, to the public in the Member State in which the public offer is made and at the registered office of the person making the public offer and at the offices of the financial organizations retained to act as paying agents of the latter in the Member State where the offer is made. 4. In addition, either the complete prospectus or a notice stating where the prospectus has been published and where it may be obtained by the public must be inserted in a publication designated by the Member State in which the public offer is made. SECTION III Contents and arrangements for the distribution of the prospectus for transferable securities for which admission to official stock-exchange listing is not sought Article 11 1. Where a public offer relates to transferable securities other than those referred to in Articles 7 and 8, the prospectus must contain the information which, according to the particular nature of the issuer and of the transferable securities offered to the public, is necessary to enable investors to make an informed assessment of the assets and liabilities, financial position, profits and losses and prospects of the issuer and of the rights attaching to the transferable securities. 2. In order to fulfil the obligation referred to in paragraph 1, the prospectus shall, subject to the possibilities for exemption provided for in Articles 5 and 13, contain in as easily analysable and comprehensible a form a possible, at least the information listed below: (a) those responsible for the prospectus (names, functions and declarations by them that to the best of their knowledge the information contained in the prospectus is in accordance with the facts and that the prospectus makes no omission likely to affect its import); (b) the offer to the public and the transferable securities being offered (nature of the securities being offered, the amount and purpose of the issue, the number of securities issued and the rights attaching to them; the income tax withheld at source; the period during which the offer is open; the date on which entitlement to dividends or interest arises; the persons underwriting or guaranteeing the offer; any restrictions on the free transferability of the securities being offered and the markets on which they may be traded; the establishments serving as paying agents; if known, the price at which the securities are offered, or else, if national rules so provide, the procedure and timetable for fixing the price if it is not known when the prospectus is being drawn up; methods of payment; the procedure for the exercise of any right of pre-emption and the methods of and time-limits for delivery of the securities); (c) the issuer (name, registered office; its date of incorporation, the legislation applicable to the issuer and the issuer's legal form, its objects, indication of the register and of the entry number therein) and its capital (amount of the subscribed capital, the number and main particulars of the securities of which the capital consists and any part of the capital still to be paid up; the amount of any convertible debt securities, exchangeable debt securities or debt securities with warrants and the procedures for conversion, exchange or subscription; where appropriate, the group of undertakings to which the issuer belongs; in the case of shares, the following additional information must be supplied: any shares not representing capital, the amount of the authorized capital and the duration of the authorization; in so far as they are known, indication of the shareholders who directly or indirectly exercise or could exercise a determining role in the management of the issuer); (d) the issuer's principal activities (description of its principal activities, and, where appropriate, any exceptional factors which have influenced its activities; any dependence on patents, licences or contracts if these are of fundamental importance; information regarding investments in progress where they are significant; any legal proceedings having an important effect on the issuer's financial position); (e) the issuer's assets and liabilities, financial position and profits and losses (own accounts and, where appropriate, consolidated accounts; if the issuer prepares consolidated annual accounts only, it shall include those accounts in the prospectus; if the issuer prepares both own and consolidated accounts, it shall include both types of account in the prospectus; however, the issuer may include only one of the two, provided that the accounts which are not included do not provide any significant additional information); interim accounts if any have been published since the end of the previous financial year; the name of the person responsible for auditing the accounts; if that person has qualified them or refused an audit report, the fact must be stated and the reasons given; (f) the issuer's administration, management and supervision (names, addresses, functions; in the case of an offer to the public of shares in a limited-liability company, remuneration of the members of the issuer's administrative, management and supervisory bodies); (g) to the extent that such information would have a significant impact on any assessment that might be made of the issuer, recent developments in its business and prospects (the most significant recent trends concerning the development of the issuer's business since the end of the proceding financial year, information on the issuer's prospects for at least the current financial year). 3. Where a public offer relates to debt securities guaranteed by one or more legal persons, the information specified in paragraph 2 (c) to (g) must also be given with respect to the guarantor or guarantors. 4. Where a public offer relates to convertible debt securities, exchangeable debt securities or debt securities with warrants or to the warrants themselves, information must also be given with regard to the nature of the shares or debt securities to which they confer entitlement and the conditions of and procedures for conversion, exchange or subscription. Where the issuer of the shares or debt securities is not the issuer of the debt securities or warrants the information specified in paragraph 2 (c) to (g) must also be given with respect to the issuer of the shares or debt securities. 5. If the period of existence of the issuer is less than any period mentioned in paragraph 2, the information need be provided only for the period of the issuer's existence. 6. Where certain information specified in paragraph 2 is found to be inappropriate to the issuer's sphere of activity or its legal form or to the transferable securities being offered, a prospectus giving equivalent information must be drawn up. 7. Where shares are offered on a pre-emptive basis to shareholders of the issuer on the occasion of their admission to dealing on a stock exchange market, the Member States or bodies designated by them may allow some of the information specified in paragraph 2 (d), (e) and (f) to be omitted, provided that investors already possess up-to-date information about the issuer equivalent to that required by Section III as a result of stock exchange disclosure requirements. 8. Where a class of shares has been admitted to dealing on a stock exchange market, the Member States or bodies designated by them may allow a partial or complete exemption from the obligation to publish a prospectus if the number or estimated market value or the nominal value or, in the absence of a nominal value, the accounting par value of the shares offered amounts to less than 10 % of the number or of the corresponding value of shares of the same class already admitted to dealing, provided that investors already possess up-to-date information about the issuer equivalent to that required by Section III as a result of stock exchange disclosure requirements. Article 12 1. However, the Member States may provide that the person making a public offer shall have the possibility of drawing up a prospectus the contents of which shall, subject to adaptations appropriate to the circumstances of a public offer, be determined in accordance with Directive 80/390/EEC. 2. The prior scrutiny of the prospectus referred to in paragraph 1 must be carried out by the bodies designated by the Member States even in the absence of a request for admission to official stock-exchange listing. Article 13 1. The Member States or the bodies designated by them may authorize the omission from the prospectus referred to in Article 11 of certain information prescribed by this Directive: (a) if that information is of minor importance only and is not likely of influence assessment of the issuer's assets and liabilities, financial position, profits and losses and prospects; or (b) if disclosure of that information would be contrary to the public interest or seriously detrimental to the issuer, provided that, in the latter case, omission would not be likely to mislead the public with regard to facts and circumstances essential for assessment of the transferable securities. 2. Where the initiator of an offer is neither the issuer nor a third party acting on the issuer's behalf, the Member States or the bodies designated by them may authorize omission from the prospectus of certain information which would not normally be in the initiator's possession. 3. The Member States or the bodies designated by them may provide for partial or complete exemption from the obligation to publish a prospectus where the information which those making the offer are required to supply by law, regulation or rules made by bodies enabled to do so by national laws is available to investors not later than the time when the prospectus must be or should have been published or made available to the public, in accordance with this Directive, in the form of documents giving information at least equivalent to that required by Section III. Article 14 Article 14 A prospectus must be communicated, before its publication, to the bodies designated for that purpose in each Member State in which the transferable securities are offered to the public for the first time. Article 15 A prospectus must be published or made available to the public in the Member State in which an offer to the public is made in accordance with the procedures laid down by that Member State. Article 16 A prospectus must be published or made available to the public not later than the time when an offer is made to the public. Article 17 1. When a prospectus complying with Article 11 or 12 is or must be published, the advertisements, notices, posters and documents announcing the public offer distributed or made available to members of the public by the person making the public offer, must be communicated in advance to the bodies designated in accordance with Article 14, if such bodies carry out prior scrutiny of public offer prospectuses. In such a case, the latter shall determine whether the documents concerned should be checked before publication. Such documents must state that a prospectus exists and indicate where it is published. 2. If Member States authorize the dissemination of the documents referred to in paragraph 1 before the prospectus is available, those documents must state that a prospectus will be published and indicate where members of the public will be able to obtain it. Article 18 Any significant new factor or significant inaccuracy in a prospectus capable of affecting assessment of the transferable securities which arises or is noted between the publication of the prospectus and the definitive closure of a public offer must be mentioned or rectified in a supplement to the prospectus, to be published or made available to the public in accordance with at least the same arrangements as were applied when the original prospectus was disseminated or in accordance with procedures laid down by the Member States or by the bodies designated by them. SECTION IV Cooperation between Member States Article 19 The Member States shall designate the bodies, which may be the same as those referred to in Article 14, which shall cooperate with each other for the purposes of the proper application of this Directive and shall use their best endeavours, within the framework of their responsibilities, to exchange all the information necessary to that end. Member States shall inform the Commission of the bodies thus designated. The Commission shall communicate that information to the other Member States. Member States shall ensure that the bodies designated have the powers required for the accomplishment of their task. Article 20 1. Where, for the same transferable securities, public offers are made simultaneously or within a short interval of one another in two or more Member States and where a public offer prospectus is drawn up in accordance with Arcticle 7, 8 or 12, the authority competent for the approval of the prospectus shall be that of the Member State in which the issuer has its registered office if the public offer or any application for admission to official listing on a stock exchange is made in that Member State. 2. However, if the Member State referred to in paragraph 1 does not provide in general for the prior scrutiny of public offer prospectuses and if only the public offer or an application for admission to listing is made in that Member State, as well as in all other cases, the person making the public offer must choose the supervisory authority from those in the Member States in which the public offer is made and which provide in general for the prior scrutiny of public offer prospectuses. SECTION V Mutual recognition Article 21 1. If approved in accordance with Article 20, a prospectus must, subject to translation if required, be recognized as complying or be deemed to comply with the laws of the other Member States in which the same transferable securities are offered to the public simultaneously or within a short interval of one another, without being subject to any form of approval there and without those States being able to require that additional information be included in the prospectus. Those Member States may, however, require that the prospectus include information specific to the market of the country in which the public offer is made concerning in particular the income tax system, the financial organizations retained to act as paying agents for the issuer in that country, and the way in which notices to investors are published. 2. A prospectus approved by the competent authorities within the meaning of Article 24a of Directive 80/390/EEC must be recognized as complying or be deemed to comply with the laws of another Member State in which the public offer is made, even if partial exemption or partial derogation has been granted pursuant to this Directive, provided, however, that: (a) the partial exemption or partial derogation in question is of a type that is recognized in the rules of the other Member State concerned; and (b) the circumstances that justify the partial exemption or partial derogation also exist in the other Member State concerned. Even if the conditions laid down in (a) and (b) of the first subparagraph are not fulfilled, the Member State concerned may deem a prospectus approved by the competent authorities within the meaning of Article 20 to comply with its laws. 3. The person making the public offer shall communicate to the bodies designated by the other Member States in which the public offer is to be made the prospectus that it intends to use in that State. That prospectus must be the same as the prospectus approved by the authority referred to in Article 20. 4. The Member States may restrict the application of this Article to prospectuses concerning transferable securities of issuers who have their registered office in a Member State. SECTION VI Cooperation Article 22 1. The competent authorities shall cooperate wherever necessary for the purpose of carrying out their duties and shall exchange any information required for that purpose. 2. Where a public offer concerning transferable securities giving a right to participate in company capital, either immediately or at the end of a maturity period, is made in one or more Member States other than that in which the registered office of the issuer of the shares to which those securities give entitlement is situated, while that issuer's shares have already been admitted to official listing in that Member State, the competent authorities of the Member State of the offer may act only after having consulted the competent authorities of the Member State in which the registered office of the issuer of the shares in question is situated in cases where the public offer prospectus is scrutinized. Article 23 1. Member States shall provide that all persons then or previously employed by the authorities referred to in Article 20 shall be bound by the obligation of professional secrecy. This shall mean that they may not divulge any confidential information received in the course of their duties to any person or authority whatsoever, except by virtue of provisions laid down by law. 2. Paragraph 1 shall not prevent the various Member State authorities referred to in Article 20 from forwarding information as provided for in this Directive. The information thus exchanged shall be covered by the obligation of professional secrecy applying the persons employed then or previously by the authority receiving such information. 3. Without prejudice to cases covered by criminal law, the authorities referred to in Article 20 receiving information pursuant to Article 21 may use it only to carry out their functions or in the context of an administrative appeal or in court proceedings relating to the carrying out of those functions. SECTION VII Negotiations with non-member countries Article 24 The Community may, by means of agreements with one or more non-member countries concluded pursuant to the Treaty, recognize public offer prospectuses drawn up and scrutinized in accordance with the rules of the non-member country or countries concerned as meeting the requirements of this Directive, subject to reciprocity, provided that the rules concerned give investors protections equivalent to that afforded by this Directive, even if those rules differ from the provisions of this Directive. SECTION VIII Contact Committee Article 25 1. The Contact Committee set up by Article 20 of Council Directive 79/279/EEC of 5 March 1979 coordinating the conditions for the admission of transferable securities to official stock-exchange listing (8), as last amended by Directive 82/148/EEC (9), shall also have as its function: (a) to facilitate, without prejudice to Articles 169 and 170 of the Treaty, the harmonized implementation of this Directive through regular consultations on any practical problems arising from its application on which exchanges of views are deemed useful; (b) to facilitate consultation between the Member States on the supplements and improvements to prospectuses which they are entitled to require or recommend at national level; (c) to advise the Commission, if necessary, on any additions or amendments to be made to this Directive. 2. It shall not be the function of the Contact Committee to appraise the merits of decisions taken in individual cases. SECTION IX Final provisions Article 26 1. Member States shall take the measures necessary for them to comply with this Directive by 17 April 1989. They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 27 This Directive is addressed to the Member States.

31989L0342

1989

Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums and allergens Hacing 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 disparities in the provisions laid down by law, regulation or administrative action by Member States may hinder trade in immunological products within the Community; Whereas the essential aim of any rules governing the production, distribution or use of medicinal products must be to safeguard public health; Whereas Directive 65/65/EEC (4), as last amended by Directive 87/21/EEC (5), and Second Directive 75/319/EEC (6), as last amended by Directive 83/570/EEC (7), on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, although appropriate, are inadequate for immunological medicinal products consisting of vaccines, toxins or serums and allergens; Whereas, in accordance with Article 5 of Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology (8), the Commission is required to submit proposals to harmonize, along the lines of Directive 75/319/EEC, the conditions for authorizing the manufacture and placing on the market of immunological medicinal products before 22 December 1987; 16. 5. 1989. Whereas, before an authorization to market an immunological product can be granted, the manufacturer must demonstrate his ability to attain batch-to-batch consistency; Whereas the Commission should be empowered to adopt any necessary changes in the requirements for the testing of proprietary medicinal products set out in the Annex to 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 (9), as last amended by Directive 87/19/EEC (10), to take account of the special nature of immunological medicinal products in close cooperation with the Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Proprietary Medicinal Products Sector, thus ensuring greater quality, safety and efficacy, Article 1 1. In derogation from Article 34 of Directive 75/319/EEC, and subject to the provisions of this Directive, Directives 65/65/EEC and 75/319/EEC shall apply to immunological medicinal products for human use consisting of vaccines, toxins or serums and allergen products. 2. For the purposes of this Directive, the following definitions shall apply: - 'allergen product' shall mean any product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent, - vaccines, toxins and serums shall have the meaning assigned to them in the Annex to Directive 75/319/EEC. Article 2 1. The quantitative particulars of an immunological medicinal product shall be expressed by mass or by international units or by units of biological activity or by specific protein content, where possible, as appropriate to the product concerned. ¹ 2. In respect of immunological products in Directives 65/65/EEC and 75/319/EEC the expressions 'qualitative and quantitative particulars of the constitutents' shall also include particulars relating to biological activity or to protein content and 'qualitative and quantitative composition' shall include the composition of the product expressed in terms of biological activity or of protein content. 3. Whenever the name of an immunological medicinal product is expressed, the common or scientific name of the active constituents shall also be included. Article 3 In addition to the information referred to in Article 4a of Directive 65/65/EEC the summary of product characteristics referred to in point 9 of the second subparagraph of Article 4 of Directive 65/65/EEC shall contain the following information in respect of immunological products: - under point 5.4, information regarding any special precautions to be taken by persons handling the immunological medicinal product and persons administering it to patients, together with any precautions to be taken by the patient. Article 4 1. Member States shall take all appropriate steps to ensure that the manufacturing processes used in the manufacture of immunological products are properly validated and attain batch-to-batch consistency. 2. For the purpose of implementing Article 8 of Directive 65/65/EEC and Article 27 of Directive 75/319/EEC, Member States may require manufacturers of immunological products to submit to a competent authority copies of all the control reports signed by the qualified person in accordance with Article 22 of Directive 75/319/EEC. 3. Where it considers it necessary in the interests of public health, a Member State may require persons responsible for marketing: - live vaccines, - immunological medicinal products used in the primary immunization of infants or of other groups at risk, - immunological medicinal products used in public health immunization programmes, - new immunological medicinal products or immunological medicinal products manufactured using new or altered kinds of technology or new for a particular manufacturer, during a transitional period normally specified in the marketing authorization, to submit samples from each batch of the bulk and/or finished product for examination by a State laboratory or a laboratory designated for that purpose before release on to the market unless, in the case of a batch manufactured in another Member State, the competent authority of another Member State has previously examined the batch in question and declared it to be in conformity with the approved specifications. Member States shall ensure that any such examiniation is completed within 60 days of the receipt of the samples. Article 5 Any amendents which are necesssary in the testing requirements for medicinal products set out in the Annex to Directive 75/318/EEC to take account of the extension of the scope of Directives 65/65/EEC and 75/319/EEC to cover immunological medicinal products shall be adopted in accordance with the procedure laid down in Article 2c of Directive 75/318/EEC. Article 6 1. Except as provided in paragraph 2, Member States shall take the necessary measures to comply with this Directive not later than 1 January 1992. They shall forthwith inform the Commission thereof. 2. If the amendments to Directive 75/318/EEC referred to in Article 5 have not been adopted by the date referred to in paragraph 1, this Directive shall come into force on the same date as those amendments. 3. Requests for marketing authorizations for products covered by this Directive lodged after the date on which it comes into force must comply with the provisions of this Directive. 4. This Directive shall be progressively extended to existing immunological medicinal products before 31 December 1992. Article 7 This Directive is addressed to the Member States.

31989L0343

1989

Council Directive 89/343/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for radiopharmaceuticals 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 disparities in the provisions currently laid down by law, regulation or administrative action by Member States may hinder trade in radiopharmaceuticals within the Community; Whereas the essential aim of any rules governing the production, distributio or use of medicinal products must be to safeguard public health; Whereas the provisions laid down by Directive 65/65/EEC (4), as last amended by Directive 87/21/EEC (5), and by Second Directive 75/319/EEC (6), as last amended by Directive 83/570/EEC (7), on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, although appropriate, are inadequate for radiopharmaceuticals; Whereas, in accordance with Article 5 of Council Directive 87/22/EEC of 22 December 1986 on the approximation of national provisions relating to the placing on the market of high technology medicinal products, particularly those derived from biotechnology (8), the Commission is required to submit proposals to harmonize, along the lines of Directive 75/319/EEC, the conditions for authorizing the manufacture and placing on the market of radiopharmaceuticals before 22 December 1987; Whereas, in the case of radiopharmaceuticals, generators, kits and precursors, authorization should be required; whereas, however, a specific authorization should not be required for radiopharmaceuticals in their finished form which are made up exclusively from authorized kits, generators or precursor radiopharmaceuticals in health care establishments; Whereas the Commission should be empowered to adopt any necessary changes in the requirements for the testing of proprietary medicinal products set out in the Annex to Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (9), as last amended by Directive 87/19/EEC (10), to take account of the special nature of radiopharmaceuticals in close cooperation with the Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Proprietary Medicinal Products Sector, thus ensuring the greater quality, safety and efficacy of the medicinal products; Whereas any rules governing radiopharmaceuticals must take into account the provisions 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 (11); whereas account should also be taken of 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 (12), as last amended by Directive 84/467/Euratom (13), the objective of which is to prevent the exposure of workers or patients to excessive or unnecessarily high levels of ionizing radiation, and in particular of Article 5c thereof, which requires prior authorization for the addition of radioactive substances to medicinal products as well as for the importation of such medicinal products, Article 1 1. In derogation from Article 34 of Directive 75/319/EEC, and subject to the provisions of this Directive, ¹ the provisions of Directives 65/65/EEC and 75/319/EEC shall apply to radiopharmaceuticals for human use, excluding radionuclides in the form of sealed sources. 2. For the purposes of this Directive, the following definitions apply: - 'radiopharmaceutical' shall mean any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medicinal purpose, - 'generator' shall mean any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be removed by elution or by any other method and used in a radiopharmaceutical, - 'kit' shall mean any preparation to be reconstituted or combined with radionucliedes in the final radiopharmaceutical, usually prior to its administration, - 'precursor' shall mean any other radionuclide produced for the radio-labelling of another substance prior to administration. 3. Nothing in this Directive shall in any way derogate from the Community rules for the radiation protection of persons undergoing medical examination or treatment or from the Community rules laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation. Article 2 The authorization referred to in Article 3 of Directive 65/65/EEC shall be required for generators, kits, precursor radiopharmaceuticals and industrially prepared radiopharmaceuticals. However, authorization shall not be required for a radiopharmaceutical prepared at the time of use by a person or by an establishment authorized, according to national legislation, to use such medicinal products in an approved health care establishment exclusively from authorized generators, kits or precursor radiopharmaceuticals in accordance with the manufacturer's instructions. Article 3 In addition to the requirements set out in Article 4 of Directive 65/65/EEC, an application for authorization to market a generator shall also contain the following information and particulars: - a general description of the system together with a detailed description of the components of the system which may effect the composition or quality of the daughter nucleid preparation, - qualitative and quantitative particulars of the eluate or the sublimate. Article 4 For radiopharmaceuticals, in addition to the information referred to in Article 4a of Directive 65/65/EEC, the summary of product characteristics referred to in point 9 of the second paragraph of Article 4 of Directive 65/65/EEC shall contain the following additional points 7 and 8: '7. Full details of internal radiation dosimetry. '8. Additional detailed instructions for extemporaneous preparation and quality control of such preparation and, where appropriate, maximum storage time during which any intermediate preparation such as an eluate or the ready to use pharmaceutical will conform with its specifications.' Article 5 The outer carton and the container of medicinal products containing radionuclides shall be labelled in accordance with the regulations for the safe transport of radioactive materials laid down by the International Atomic Energy Agency. Moreover, the labelling shall comply with the following provisions: (a) The label on the shielding shall include the particulars mentioned in Article 13 of Directive 65/65/EEC. In addition, the labelling on the shielding shall explain in full the codings used on the vial and shall indicate, where necessary, for a given time and date, the amount of radioactivity per dose or per vial and the number of capsules, or, for liquids, the number of millilitres in the container; (b) The vial shall be labelled with the following information: - the name or code of the medicinal product, including the name or chemical symbol of the radionuclide; - the batch identification and expiry date, - the international symbol for radioactivity, - the name of the manufacturer, - the amount of radioactivity as specified under (a). Article 6 1. Member States shall ensure that a detailed instruction leaflet is enclosed with the packaging of radiopharmaceuticals, generators, kits or precursor radiopharmaceuticals. The text of this leaflet shall be established in accordance with the provisions of Article 6 of Directive 75/319/EEC and shall contain all the information referred to therein. In addition, the leaflet shall include any precautions to be taken by the user and the patient during the preparation and administration of the product and special precautions for the disposal of the container and its unused contents. 2. Without prejudice to Article 8 of Directive 65/65/EEC and Article 6 of Directive 75/319/EEC, Member States shall permit the use of user information leaflets which have been established in more than one of the languages of the Community provided that the information contained in all the language versions of the leaflet is identical. Article 7 Any amendments which are necessary in the testing requirements for medicinal products set out in the Annex to Directive 75/318/EEC to take account of the extension of the scope of Directives 65/65/EEC and 75/319/EEC to cover radiopharmaceuticals shall be adopted in accordance with the procedure laid down in Article 2c of Directive 75/318/EEC. Article 8 1. Save in the case provided for in paragraph 2, Member States shall take the necessary measures to comply with this Directive not later than 1 January 1992. They shall forthwith inform the Commission thereof. 2. If the amendments to Directive 75/318/EEC referred to in Article 7 have not been adopted by the date referred to in paragraph 1, this Directive shall come into force on the same date as those amendments. 3. Requests for marketing authorization for products covered by ths Directive lodged after the date of entry into force must comply with the provisions of this Directive. 4. This Directive shall be progressively extended to existing radiopharmaceutical medicinal products covered by this Directive before 31 December 1992. Article 9 This Directive is addressed to the Member States.

31989L0336

1989

Council Directive 89/336/EEC of 3 May 1989 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 it is necessary to adopt measures 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 Member States are responsible for providing adequate protection for radiocommunications and the devices, apparatus or systems whose performance may be degraded by electromagnetic disturbance produced by electrial and electronic apparatus against the degradation caused by such disturbances; Whereas Member States are also responsible for ensuring that electric energy distribution networks are protected from electromagnetic disturbance with can affect them and, consequently, equipment fed by them; Whereas Council Directive 86/361/EEC of 24 July 1986 on the initial stage of the recognition of type-approval for telecommunications terminal equipment (4) covers in particular the signals emitted by such equipment when it is operating normally and the protection of public telecommunications networks from harm; whereas it is therefore still necessary to provide adequate protection for these networks, including the equipment connected to them, against temporary disturbances caused by signals of an accidental nature that may be emitted by this equipment; Whereas in some Member States, mandatory provisions define in particular the permissible electromagnetic disturbance levels that this equipment is liable to cause and its degree of immunity to such signals; whereas these mandatory provisions do not necessarily lead to different protection levels from one Member State to another but do, by their disparity, hinder trade within the Community; Whereas the national provisions ensuring such protection must be harmonized in order to guarantee the free movement of electrical and electronic apparatus without lowering existing and justified levels of protection in the Member States; Whereas Community legislation as it stands at present provides that, notwithstanding one of the fundamental rules of the Community, namely the free movement of goods, barriers to intra-Community trade resulting from disparities in national laws on the marketing of products have to be accepted in so far as those provisions may be recognized as necessary to satisfy essential requirements; whereas the harmonization of laws in the case in point must therefore be confined to those provisions needed to comply with the protection requirements relating to electromagnetic compatibility; whereas these requirements must replace the corresponding national provisions; Whereas this Directive therefore defines only protection requirements relating to electromagnetic compatibility; whereas, to facilitate proof of conformity with these requirements, it is important to have harmonized standards at European level concerning electromagnetic compatibility, so that products complying with them may be assumed to comply with the protection requirements; whereas these standards harmonized at European level are drawn up by private bodies and must remain non-binding texts; whereas for that purpose the European Committee for Electrotechnical Standardization (CENELEC) is recognized as the competent body in the field of this Directive for the adoption of harmonized standards in accordance with the general guidelines for cooperation between the Commission and the European Committee for Standardization (CEN) and CENELEC signed on 13 November 1984; whereas, for the purposes of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted by CENELEC upon a remit from the Commission in accordance with the provisions of Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (1), as last amended by Directive 88/182/EEC (2), and pursuant to the abovementioned general guidelines; Whereas, pending the adoption of harmonized standards for the purposes of this Directive, the free movement of goods should be facilitated by accepting, as a transitional measure, on a Community level, apparatus complying with the national standards adopted, in accordance with the Community inspection procedure ensuring that such national standards meet the protection objectives of this Directive; Whereas the EC declaration of conformity concerning the apparatus constitutes a presumption of its conformity with this Directive; whereas this declaration must take the simplest possible form; Whereas, for apparatus covered by Directive 86/361/EEC, in order to obtain efficient protection as regards electromagnetic compatibility, compliance with the provisions of this Directive should nevertheless be certified by marks or certificates of conformity issued by bodies notified by the Member States; whereas, to facilitate the mutual recognition of marks and certificates issued by these bodies, the criteria to be taken into consideration for appointing them should be harmonized; Whereas it is nevertheless possible that equipment might disturb radiocommunications and telecommunications networks; whereas provision should therefore be made for a procedure to reduce this hazard; Whereas this Directive applies to the appliances and equipment covered by Directives 76/889/EEC (3) and 76/890/EEC (4) which relate to the approximation of the laws of the Member States relating to radio interference caused by electrical household appliances, portable tools and similar equipment and to the suppression of radio interference with regard to fluorescent lighting luminaires fitted with starters; whereas those Directive should therefore be repealed, Article 1 For the purposes of this Directive: 1. 'apparatus' means all electrical and electronic appliances together with equipment and installations containing electrical and/or electronic components. 2. 'electromagnetic disturbance' means any electromagnetic phenomenon which may degrade the performance of a device, unit of equipment or system. An electromagnetic disturbance may be electromagnetic noise, an unwanted signal or a change in the propagation medium itself. 3. 'immunity' means the ability of a device, unit of equipment or system to perform without degradation of quality in the presence of an electromagnetic disturbance. 4. 'electromagnetic compatibility' means the ability of a device, unit of equipment or system to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbances to anything in that environment. 5. 'competent body' means any body which meets the criteria listed in Annex II and is recognized as such. 6. 'EC type-examination certificate' is a document in which a notified body referred to in Article 10 (6) certifies that the type of equipment examined complies with the provisions of this Directive which concern it. Article 2 1. This Directive applies to apparatus liable to cause electromagnetic disturbance or the performance of which is liable to be affected by such disturbance. It defines the protection requirements and inspection procedures relating thereto. 2. In so far as protection requirements specified in this Directive are harmonized, in the case of certain apparatus, by specific Directives, this Directive shall not apply or shall cease to apply with regard to such apparatus or protection requirements upon the entry into force of those specific Directives. 3. Radio equipment used by radio amateurs within the meaning of Article 1, definition 53, of the radio regulations in the International Telecommunications Convention, shall be excluded from the scope of this Directive, unless the apparatus is available commercially. Article 3 Member States shall take all appropriate measures to ensure that apparatus as referred to in Article 2 may be placed on the market or taken into service only if it complies with the requirements laid down by this Directive when it is properly installed and maintained and when it is used for the purposes for which it is intended. Article 4 The apparatus referred to in Article 2 shall be so constructed that: (a) the electromagnetic disturbance it generates does not exceed a level allowing radio and telecommunications equipment and other apparatus to operate as intended; (b) the apparatus has an adequate level of intrinsic immunity of electromagnetic disturbance to enable it to operate as intended. The principal protection requirements are set out in Annex III. Article 5 Member States shall not impede for reasons relating to electromagnetic compatibility the placing on the market and the taking into service on their territory of apparatus covered by this Directive which satisfies the requirements thereof. Article 6 1. The requirements of this Directive shall not prevent the application in any Member State of the following special measures: (a) measures with regard to the taking into service and use of the apparatus taken for a specific site in order to overcome an existing or predicted electromagnetic compatibility problem; (b) measures with regard to the installation of the apparatus taken in order to protect the public telecommunications networks or receiving or transmitting stations used for safety purposes. 2. Without prejudice to Directive 83/189/EEC, Member States shall inform the Commission and the other Member States of the special measures taken pursuant to paragraph 1. 3. Special measures that have been recognized as justified shall be contained in an appropriate notice made by the Commission in the Official Journal of the European Communities. Article 7 1. Member States shall presume compliance with the protection requirements referred to in Article 4 in the case of apparatus which is in conformity; (a) with the relevant national standards transposing the harmonized standards, the reference numbers of which have been published in the Official Journal of the European Communities. Member States shall publish the reference numbers of such national standards; (b) or with the relevant national standards referred to in paragraph 2 in so far as, in the areas covered by such standards, no harmonized standards exist. 2. Member States shall communicate to the Commission the texts of their national standards, as referred to in paragraph 1 (b), which they regard as complying with the protection requirements referred to in Article 4. The Commission shall forward such texts forthwith to the other Member States. In accordance with the procedure provided for in Article 8 (2), it shall notify the Member States of those national standards in respect of which there is a presumption of conformity with the protection requirements referred to in Article 4. Member States shall publish the reference numbers of those standards. The Commission shall also publish them in the Official Journal of the European Communities. 3. Member States shall accept that where the manufacturer has not applied, or has applied only in part, the standards referred to in paragraph 1, or where no such standards exist, apparatus shall be regarded as satisfying the protection requirements has been certified by the means of attestation provided for in Article 10 (2). Article 8 1. Where a Member State or the Commission considers that the harmonized standards referred to in Article 7 (1) (a) do not entirely satisfy the requirements referred to in Article 4, the Member State concerned or the Commission shall bring the matter before the Standing Committee set up by Directive 83/189/EEC, hereinafter referred to as 'the Committee', giving the reasons therefor. The Committee shall deliver an opinion without delay. Upon receipt of the Committee's opinion, the Commission shall inform the Member States as soon as possible whether or not it is necessary to withdraw in whole or in part those standards from the publications referred to in Article 7 (1) (a). 2. After receipt of the communication referred to in Article 7 (2), the Commission shall consult the Committee. Upon receipt of the latter's opinion, the Commission shall inform the Member States as soon as possible whether or not the national standard in question shall enjoy the presumption of conformity and, if so, that the references thereof shall be published nationally. If the Commission or a Member State considers that a national standard no longer satisfies the necessary conditions for presumption of compliance with the protection requirements referred to in Article 4, the Commission shall consult the Committee, which shall give its opinion without delay. Upon receipt of the latter's opinion, the Commission shall inform the Member States as soon as possible whether or not the standard in question shall continue to enjoy a presumption of conformity and, if not, that it must be withdrawn in whole or in part from the publications referred to in Article 7 (2). Article 9 1. Where a Member State ascertains that apparatus accompanied by one of the means of attestation provided for in Article 10 does not comply with the protection requirements referred to in Article 4, it shall take all appropriate measures to withdraw the apparatus from the market, prohibit its placing on the market or restrict its free movement. The Member State concerned shall immediately inform the Commission of any such measure, indicating the reasons for its decision and, in particular, whether non-compliance is due to: (a) failure to satisfy the protection requirements referred to in Article 4, where the apparatus does not meet the standards referred to in Article 7 (1); (b) incorrect application of the standards referred to in Article 7 (1); (c) shortcomings in the standards referred to in Article 7 (1) themselves. 2. The Commission shall consult the parties concerned as soon as possible. If the Commission finds, after such consultations, that the action is justified, it shall forthwith so inform the Member State that took the action and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission, after consulting the parties, shall bring the matter before the Committee within two months if the Member State which has taken the measures intends to uphold them, and shall initiate the procedures referred to in Article 8. 3. Where apparatus which does not comply is accompanied by one of the means of attestation referred to in Article 10, the competent Member State shall take appropriate action against the author of the attestation 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 10 1. In the case of apparatus for which the manufacturer has applied the standards referred to in Article 7 (1), the conformity of apparatus with this Directive shall be certified by an EC declaration of conformity issued by the manufacturer or his authorized representative established within the Community. The declaration shall be held at the disposal of the competent authority for ten years following the placing of the apparatus on the market. The manufacturer or his authorized representative established within the Community shall also affix the EC conformity mark to the apparatus or else to the packaging, instructions for use or guarantee certificate. Where neither the manufacturer nor his authorized representative is established within the Community, the above obligation to keep the EC declaration of conformity available shall be the responsibility of the person who places the apparatus on the Community market. The provisions governing the EC declaration and the EC mark are set out in Annex I. 2. In the case of apparatus for which the manufacturer has not applied, or has applied only in part, the standards referred to in Article 7 (1) or failing such standards, the manufacturer or his authorized representative established within the Community shall hold at the disposal of the relevant competent authorities, as soon as the apparatus is placed on the market, a technical construction file. This file shall describe the apparatus, set out the procedures used to ensure conformity of the apparatus with the protection requirements referred to in Article 4 and include a technical report or certificate, one or other obtained from a competent body. The file shall be held at the disposal of the competent authorities for ten years following the placing of the apparatus on the market. Where neither the manufacturer nor his authorized representative is established within the Community, this obligation to keep a technical file available shall be the responsibility of the person who places the apparatus on the Community market. The conformity of apparatus with that described in the technical file shall be certified in accordance with the procedure laid down in paragraph 1. Member States shall presume, subject to the provisions of this paragraph, that such apparatus meets the protection requirements referred to in Article 4. 3. Where the standards referred to in Article 7 (1) are not yet in existence, and without prejudice to the provisions of paragraph 2 of this Article, the apparatus concerned may, on a transitional basis until 31 December 1992 at the latest, continue to be governed by the national arrangements in force on the date of adoption of this Directive, subject to the compatibility of such arrangements with the provisions of the Treaty. 4. Conformity of apparatus covered by Article 2 (2) of Directive 86/361/EEC with the provisions of this Directive shall be certified in accordance with the procedure laid down in paragraph 1 once the manufacturer or his authorized representative established within the Community has obtained an EC type-examination certificate concerning this apparatus issued by one of the notified bodies referred to in paragraph 6 of this Article. 5. The conformity of apparatus designed for the transmission of radiocommunications, as defined in the International Telecommunication Union Convention, with the provisions of this Directive shall be certified in accordance with the procedure laid down in paragraph 1 once the manufacturer or his authorized representative established within the Community has obtained an EC type-examination certificate concerning this apparatus issued by one of the notified bodies referred to in paragraph 6 below. This provision shall not apply to the above apparatus where it is designed and intended exclusively for radio amateurs within the meaning of Article 2 (3). 6. Each Member State shall notify the Commission and the other Member States of the competent authorities referred to in this Article and of the bodies responsible for issuing the EC type-examination certificates referred to in paragraphs 4 and 5. The Commission shall publish a list of those authorities and bodies, for information purposes, in the Official Journal of the European Communities and shall ensure that the list is updated. Such notification shall state whether those bodies are competent for all apparatus covered by this Directive or whether their responsibility is limited to certain specific areas. Member States shall apply the criteria listed in Annex II for the assessment of the bodies to be notified. Bodies which comply with the assessment criteria fixed by the relevant harmonized standards shall be presumed to comply with the aforementioned criteria. A Member State which has notified a body must withdraw approval if it finds that the body no longer meets the criteria listed in Annex II. It shall forthwith inform the Commission and the other Member States thereof. Article 11 Directive 76/889/EEC and Directive 76/890/EEC shall be repealed as from 1 January 1992. Article 12 1. By 1 July 1991, Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall inform the Commission thereof. They shall apply these provisions as from 1 January 1992. 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 13 This Directive is addressed to the Member States.

31989L0341

1989

Council Directive 89/341/EEC of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary 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 the essential aim of any rules governing the production, distribution or use of medicinal products must be to safeguard public health; Whereas the Directives on the approximation of the laws relating to proprietary medicinal products must be adapted to scientific progress and take account of the experience obtained since their adoption so as to ensure improved quality and greater safety and efficacy; Whereas, in its conclusions of 15 May 1987 on improvement in the use of proprietary medicinal products by consumers (4), the Council considered that the system for leaflets accompanying proprietary medicinal products, for human consumption, on the market in the Community should be improved; Whereas the guarantees of the quality of medicinal products manufactured within the Community should be maintained by requiring compliance with the principles of good manufacturing practice for medicinal products irrespective of the final destination of the products; Whereas the Commission should be empowered to define in detail the principles of good manufacturing practice for medicinal products in close cooperation with the Committee for Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers in the Proprietary Medicinal Products Sector; Whereas, having regard to the resolution of the European Parliament of 13 June 1986 on the export of pharmaceutical 16. 5. 1989. products to the Third World, measures should be taken to improve the provision of information for third countries on the conditions of use of medicinal products within the Member States; Whereas the scope of Directive 65/65/EEC (5), as last amended by Directive 87/21/EEC (6), of Directive 75/318/EEC (7), as last amended by Directive 87/19/EEC (8), and of Second Directive 75/319/EEC (9), as last amended by Directive 83/570/EEC (10), should be extended to cover other industrially produced medicinal products hitherto excluded, Article 1 Directive 65/65/EEC is hereby amended as follows: 1. In the title, preamble and Chapters II to V, all references to 'proprietary medicinal product' are replaced by 'medicinal product'. 2. In Article 1, the following points are inserted: '4. Magistral formula: Any medicinal product prepared in a pharmacy in accordance with a prescription for an individual patient. 5. Official formula: Any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the patients served by the pharmacy in question.' 3. Article 2 is replaced by the following: 'Article 2 1. Chapters II to V shall apply to proprietary medicinal products for human use intended to be placed on the market in Member States. ¹ ¹ ¹ ¹ ¹ 2. Where a Member State authorizes the placing on the market of industrially produced medicinal products which do not comply with the definition of a proprietary medicinal product, it shall also apply Chapters II to V to them. 3. Chapters II to V shall not apply to: - medicinal products prepared on the basis of a magistral or official formula, - medicinal products intended for research and development trials, - intermediate products intended for further processing by an authorized manufacturer. 4. A Member State may, in accordance with legislation in force and to fulfil special needs, exclude from Chapters II to V medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorized health care professional and for use by his individual patients on his direct personal responsibility.' 4. In Article 4a, the following point is added: '6.6. special precautions for disposal of unused products or waste materials derived from such products, if appropriate.' 5. In Article 13, the following point is added: '9. special precautions for disposal of unused products or waste materials derived from such products, if appropriate.' 6. In Article 14, the following fifth indent is added: '- manufacturer's batch number.' Article 2 In Directive 75/318/EEC all references to 'proprietary medicinal product' or to 'proprietary product' are replaced by 'medicinal product'. Article 3 Directive 75/319/EEC is hereby amended as follows: 1. In Article 4, (b) is replaced by the following: '(b) may submit the medicinal product, its starting materials and, if need be, its intermediate products or other constituent materials for testing by a State laboratory or by a laboratory designated for that purpose in order to ensure that the control methods employed by the manufacturer and described in the particulars accompanying the application in accordance with the second subparagraph of point 7 of Article 4 of Directive 65/65/EEC are satisfactory.' 2. In Article 6, the last subparagraph is replaced by the following: 'The inclusion of a package leaflet in the packaging of medicinal products shall be obligatory unless all the information required by this Article is directly conveyed on the container itself and the outer packaging.' 3. Article 16, (1) is replaced by the following: '1. Member States shall take all appropriate measures to ensure that the manufacture of medicinal products is subject to the holding of an authorization. This manufacturing authorization shall be required notwithstanding that the medicinal products manufactured are intended for export.' 4. In Article 19, the following point is added: '(f) to comply with the principles and guidelines of good manufacturing practice for medicinal products as laid down by Community law.' 5. The following Article is inserted: 'Article 19a The principles and guidelines of good manufacturing practices for medicinal products referred to in Article 19 (f) shall be adopted in the form of a directive addressed to the Member States, in accordance with the procedure laid down in Article 2c of Directive 75/318/EEC. Detailed guidelines in line with those principles will be published by the Commission and revised as necessary to take account of technical and scientific progress.' 6. In Article 26: - the first subparagraph is replaced by the following: 'The competent authority of the Member State concerned shall ensure, by means of repeated inspections, that the legal requirements governing medicinal products are complied with.', - the following subparagraph is inserted: 'After every inspection as referred to in the first subparagraph, the officials representing the competent authority shall report on whether the manufacturer complies with the principles and guidelines of good manufacturing practice laid down by Community law. The content of such reports shall be communicated to the manufacturer who has to undergo the inspection.' 7. The following Article is inserted: 'Article 28a At the request of the manufacturer, the exporter or the authorities of an importing third country, Member States shall certify that a manufacturer of medicinal products is in possession of the authorization referred to in Article 16 (1). When issuing such certificates they shall comply with the following conditions: 1. Member States shall have regard to the prevailing administrative arrangements of the World Health Organization. 2. For medicinal products intended for export which are already authorized on their territory, they shall supply the summary of the product characteristics as approved in accordance with Article 4 (b) of Directive 65/65/EEC. 3. When the manufacturer is not in possession of a marketing authorization he shall provide the authorities responsible for establishing the certificate referred to above with a declaration explaining why no marketing authorization is available.' 8. In Article 30, the following subparagraph is added: 'Upon reasoned request, Member States shall forthwith communicate the reports referred to in the third subparagraph of Article 26 to the competent authorities of another Member State. If, after considering the reports, the Member State receiving the reports considers that it cannot accept the conclusions reached by the competent authorities of the Member State in which the report was established, it shall inform the competent authorities concerned of its reasons and may request further information. The Member States concerned shall use their best endeavours to reach agreement. If necessary, in the case of serious differences of opinion, the Commission shall be informed by one of the Member States concerned.' 9. The following paragraphs are added to Article 33: '2. The person responsible for the marketing of a medicinal product shall be obliged to notify the Member States concerned forthwith of any action taken by him to suspend the marketing of a product or to withdraw a product from the market, together with the reasons for such action if the latter concerns the efficacy of the medicinal product or the protection of public health. Member States shall ensure that this information is brought to the attention of the committee. 3. Member States shall ensure that appropriate information about action taken pursuant to paragraphs 1 and 2 which may affect the protection of public health in third countries is forthwith brought to the attention of the World Health Organization, with a copy to the committee. 4. The Commission shall publish annually a list of the medicinal products which are prohibited in the Community.' 10. The first paragraph of Article 34 is hereby amended as follows: 'This Directive shall apply to medicinal products for human use within the limits referred to in Article 2 of Directive 65/65/EEC.' Article 4 1. Member States shall take the measures necessary to comply with this Directive before 1 January 1992. They shall forthwith inform the Commission thereof. 2. Requests for marketing authorizations lodged after the time limit referred to in paragraph 1 must comply with this Directive. 3. Articles 1, 2 and 3, where relevant, shall be progressively extended to existing medicinal products before 31 December 1992. Article 5 This Directive is addressed to the Member States.

31989L0365

1989

Council Directive 89/365/EEC of 30 May 1989 amending Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances (1), as last amended by Directive 87/477/EEC (2), and in particular Article 6 (3) thereof, Having regard to the proposal from the Commission, Whereas Directive 79/117/EEC provided for the contents of its Annex to be regularly amended to take account of the development of scientific and technical knowledge; Whereas, by Directive 86/355/EEC (3), amending the Annex to Directive 79/117/EEC, the marketing and use of ethylene oxide as a plant protection product was prohibited, subject to certain temporary national exceptions for certain minor commodities, where special need exists, until other methods of treatment become available; Whereas these exceptions will expire on 31 December 1989; Whereas the Commission has reviewed the situation concerning possible satisfactory alternative methods of treatment to replace ethylene oxide; whereas it appears from this review that, at present, there is no such alternative method of treatment generally available in respect of two of these exceptions; Whereas, accordingly, it seems necessary to postpone the expiry date of these two exceptions, Article 1 The Annex to Directive 79/117/EEC is hereby amended as follows: In entry C 'Ethylene oxide', in the right-hand column, the final sentence is replaced by the following: 'Derogations (a), (d), and (e) shall expire on 31 December 1989 at the latest and derogations (b) and (c) on 31 December 1990 at the latest.' Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1989. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31989L0361

1989

COUNCIL DIRECTIVE of 30 May 1989 concerning pure-bred breeding sheep and goats (89/361/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 the breeding and rearing of sheep and goats occupies an important place in Community agriculture; whereas these activities can constitute a source of income for part of the farming population; Whereas sheep and goat breeding should be encouraged and whereas satisfactory results in that respect depend largely on the use of pure-bred animals; Whereas disparities exist as regards entry in flock books; whereas those disparities constitute a barrier to trade, within the Community; whereas complete liberalization of trade calls for subsequent harmonization particularly regarding entry in flock books; Whereas, in order to remove those disparities and thereby contribute to increasing agricultural productivity in the sector, intra-Community trade should be liberalized; Whereas Member States should be authorized to require that certificates drawn up in accordance with Community procedures be presented; Whereas provisions should be introduced preventing pure-bred breeding sheep and goats from being imported from third countries on terms which are less stringent than those applicable within the Community; Whereas implementing measures should be adopted regarding certain technical aspects; whereas, for the purposes of the planned measures, provisions should be made for close cooperation between the Member States and the Commission within the Standing Committee on Zootechnics, Article 1 1. This Directive covers zootechnical problems which may arise in intra-Community trade in pure-bred breeding sheep and goats and the semen, ova and embryos thereof. 2. Pending the entry into force of the relevant Community provisions, national animal health rules shall, provided they comply with the general provisions of the EEC Treaty, apply in respect of intra-Community trade. Article 2 For the purposes of this Directive, the following definitions shall apply: (a) ‘pure-bred breeding sheep and goat’: any sheep or goat the parents and grandparents of which are entered or registered in a flock book of the same breed and which is itself entered or registered and eligible for entry therein; (b) ‘flock book’: any book, register, file or data medium: — which is maintained by a breeders' organization or association officially approved by the Member State in which that breeders' organization or association is established, or by an official agency of the Member State in question, and — in which pure-bred breeding sheep or goats of a given breed are entered or registered with mention of their ancestors. Article 3 1. Member States may not prohibit, restrict or impede on zootechnical grounds: — intra-Community trade in pure-bred breeding sheep and goats and the semen, ova and embryos thereof, — the official approval of breeders' organizations or associations which maintain or establish flock books in accordance with Article 4. 2. However, Member States may continue to apply their national provisions which comply with the general rules of the EEC Treaty pending the entry into force of the Community decisions referred to in Articles 4 and 6. Article 4 The Commission shall, in accordance with the procedure laid down in Article 8, determine before 1 January 1991: — the criteria for the approval of breeders' organizations and associations which maintain or establish flock books, — the criteria for entry or registration in flock books, — methods for monitoring performance and assessing the genetic value of pure-bred breeding sheep and goats, — the criteria for the approval of a breeding animal for the purpose of using its semen, ova or embryos. Article 5 Member States shall notify the Commission and the other Member States of the breeders' organizations and associations which are approved for the purpose of maintaining or establishing flock books and which meet the criteria determined in accordance with the first indent of Article 4. Article 6 Member States may require pure-bred breeding sheep and goats and the semen, ova and embryos of such animals to be accompanied at the time of their marketing by a zootechnical certificate drawn up in accordance with the specimen established by the Commission under the procedure set out in Article 8. Article 7 Pending the implementation of Community rules on the subject, the zootechnical conditions applicable to imports of pure-bred breeding sheep and goats and the semen, ova and embryos thereof from third countries must not be more favourable than those governing intra-Community trade. Article 8 Where the procedure laid down in this Article is to be used, the Standing Committee on Zootechnics set up by Decision 77/505/EEC (4), shall act in accordance with the rules set out in Article 11 of Directive 88/661/EEC (5). Article 9 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1991 at the latest. They shall forthwith inform the Commission thereof. Article 10 This Directive is addressed to the Member States.

31989L0391

1989

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 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 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 this Directive does not justify any reduction in levels of protection already achieved in individual Member States, the Member State being committed, under the Treaty, to encouraging improvements in conditions in this area and to harmonizing conditions while maintaining the improvements made; Whereas it is known that workers can be exposed to the effects of dangerous environmental factors at the work place during the course of their working life; Whereas, pursuant to Article 118a of the Treaty, 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 communication from the Commission on its programme concerning safety, hygiene and health at work (4) provides for the adoption of Directives designed to guarantee the safety and health of workers; Whereas the Council, in its resolution of 21 December 1987 on safety, hygiene and health at work (5), took note of the Commission's intention to submit to the Council in the near future a Directive on the organization of the safety and health of workers at the work place; Whereas in February 1988 the European Parliament adopted four resolutions following the debate on the internal market and worker protection; whereas these resolutions specifically invited the Commission to draw up a framework Directive to serve as a basis for more specific Directives covering all the risks connected with safety and health at the work place; Whereas Member States have a responsibility to encourage improvements in the safety and health of workers on their territory; whereas taking measures to protect the health and safety of workers at work also helps, in certain cases, to preserve the health and possibly the safety of persons residing with them; Whereas Member States' legislative systems covering safety and health at the work place differ widely and need to be improved; whereas national provisions on the subject, which often include technical specifications and/or self-regulatory standards, may result in different levels of safety and health protection and allow competition at the expense of safety and health; Whereas the incidence of accidents at work and occupational diseases is still too high; whereas preventive measures must be introduced or improved without delay in order to safeguard the safety and health of workers and ensure a higher degree of protection; Whereas, in order to ensure an improved degree of protection, workers and/or their representatives must be informed of the risks to their safety and health and of the measures required to reduce or eliminate these risks; whereas they must also be in a position to contribute, by means of balanced participation in accordance with national laws and/or practices, to seeing that the necessary protective measures are taken; Whereas information, dialogue and balanced participation on safety and health at work must be developed between employers and workers and/or their representatives by means of appropriate procedures and instruments, in accordance with national laws and/or practices; Whereas the improvement of workers' safety, hygiene and health at work is an objective which should not be subordinated to purely economic considerations; Whereas employers shall be obliged to keep themselves informed of the latest advances in technology and scientific findings concerning work-place design, account being taken of the inherent dangers in their undertaking, and to inform accordingly the workers' representatives exercising participation rights under this Directive, so as to be able to guarantee a better level of protection of workers' health and safety; Whereas the provisions of this Directive apply, without prejudice to more stringent present or future Community provisions, to all risks, and in particular to those arising from the use at work of chemical, physical and biological agents covered by Directive 80/1107/EEC (6), as last amended by Directive 88/642/EEC (7); Whereas, pursuant to Decision 74/325/EEC (8), 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 a Committee composed of members nominated by the Member States needs to be set up to assist the Commission in making the technical adaptations to the individual Directives provided for in this Directive. SECTION I GENERAL PROVISIONS Article 1 Object 1. The object of this Directive is to introduce measures to encourage improvements in the safety and health of workers at work. 2. To that end it contains general principles concerning the prevention of occupational risks, the protection of safety and health, the elimination of risk and accident factors, the informing, consultation, balanced participation in accordance with national laws and/or practices and training of workers and their representatives, as well as general guidelines for the implementation of the said principles. 3. This Directive shall be without prejudice to existing or future national and Community provisions which are more favourable to protection of the safety and health of workers at work. Article 2 Scope 1. This Directive shall apply to all sectors of activity, both public and private (industrial, agricultural, commercial, administrative, service, educational, cultural, leisure, etc.). 2. This Directive shall not be applicable where characteristics peculiar to certain specific public service activities, such as the armed forces or the police, or to certain specific activities in the civil protection services inevitably conflict with it. In that event, the safety and health of workers must be ensured as far as possible in the light of the objectives of this Directive. Article 3 Definitions For the purposes of this Directive, the following terms shall have the following meanings: (a) worker: any person employed by an employer, including trainees and apprentices but excluding domestic servants; (b) employer: any natural or legal person who has an employment relationship with the worker and has responsibility for the undertaking and/or establishment; (c) workers' representative with specific responsibility for the safety and health of workers: any person elected, chosen or designated in accordance with national laws and/or practices to represent workers where problems arise relating to the safety and health protection of workers at work; (d) prevention: all the steps or measures taken or planned at all stages of work in the undertaking to prevent or reduce occupational risks. Article 4 1. Member States shall take the necessary steps to ensure that employers, workers and workers' representatives are subject to the legal provisions necessary for the implementation of this Directive. 2. In particular, Member States shall ensure adequate controls and supervision.SECTION II EMPLOYERS' OBLIGATIONS Article 5 General provision 1. The employer shall have a duty to ensure the safety and health of workers in every aspect related to the work. 2. Where, pursuant to Article 7 (3), an employer enlists competent external services or persons, this shall not discharge him from his responsibilities in this area. 3. The workers' obligations in the field of safety and health at work shall not affect the principle of the responsibility of the employer. 4. This Directive shall not restrict the option of Member States to provide for the exclusion or the limitation of employers' responsibility where occurrences are due to unusual and unforeseeable circumstances, beyond the employers' control, or to exceptional events, the consequences of which could not have been avoided despite the exercise of all due care. Member States need not exercise the option referred to in the first subparagraph. Article 6 General obligations on employers 1. Within the context of his responsibilities, the employer shall take the measures necessary for the safety and health protection of workers, including prevention of occupational risks and provision of information and training, as well as provision of the necessary organization and means. The employer shall be alert to the need to adjust these measures to take account of changing circumstances and aim to improve existing situations. 2. The employer shall implement the measures referred to in the first subparagraph of paragraph 1 on the basis of the following general principles of prevention: (a) avoiding risks; (b) evaluating the risks which cannot be avoided: (c) combating the risks at source; (d) adapting the work to the individual, especially as regards the design of work places, the choice of work equipment and the choice of working and production methods, with a view, in particular, to alleviating monotonous work and work at a predetermined work-rate and to reducing their effect on health. (e) adapting to technical progress; (f) replacing the dangerous by the non-dangerous or the less dangerous; (g) developing a coherent overall prevention policy which covers technology, organization of work, working conditions, social relationships and the influence of factors related to the working environment; (h) giving collective protective measures priority over individual protective measures; (i) giving appropriate instructions to the workers. 3. Without prejudice to the other provisions of this Directive, the employer shall, taking into account the nature of the activities of the enterprise and/or establishment: (a) evaluate the risks to the safety and health of workers, inter alia in the choice of work equipment, the chemical substances or preparations used, and the fitting-out of work places. Subsequent to this evaluation and as necessary, the preventive measures and the working and production methods implemented by the employer must: - assure an improvement in the level of protection afforded to workers with regard to safety and health, - be integrated into all the activities of the undertaking and/or establishment and at all hierarchical levels; (b) where he entrusts tasks to a worker, take into consideration the worker's capabilities as regards health and safety; (c) ensure that the planning and introduction of new technologies are the subject of consultation with the workers and/or their representatives, as regards the consequences of the choice of equipment, the working conditions and the working environment for the safety and health of workers; (d) take appropriate steps to ensure that only workers who have received adequate instructions may have access to areas where there is serious and specific danger. 4. Without prejudice to the other provisions of this Directive, where several undertakings share a work place, the employers shall cooperate in implementing the safety, health and occupational hygiene provisions and, taking into account the nature of the activities, shall coordinate their actions in matters of the protection and prevention of occupational risks, and shall inform one another and their respective workers and/or workers' representatives of these risks. 5. Measures related to safety, hygiene and health at work may in no circumstances involve the workers in financial cost. Article 7 Protective and preventive services 1. Without prejudice to the obligations referred to in Articles 5 and 6, the employer shall designate one or more workers to carry out activities related to the protection and prevention of occupational risks for the undertaking and/or establishment. 2. Designated workers may not be placed at any disadvantage because of their activities related to the protection and prevention of occupational risks. Designated workers shall be allowed adequate time to enable them to fulfil their obligations arising from this Directive. 3. If such protective and preventive measures cannot be organized for lack of competent personnel in the undertaking and/or establishment, the employer shall enlist competent external services or persons. 4. Where the employer enlists such services or persons, he shall inform them of the factors known to affect, or suspected of affecting, the safety and health of the workers and they must have access to the information referred to in Article 10 (2). 5. In all cases: - the workers designated must have the necessary capabilities and the necessary means, - the external services or persons consulted must have the necessary aptitudes and the necessary personal and professional means, and - the workers designated and the external services or persons consulted must be sufficient in number to deal with the organization of protective and preventive measures, taking into account the size of the undertaking and/or establishment and/or the hazards to which the workers are exposed and their distribution throughout the entire undertaking and/or establishment. 6. The protection from, and prevention of, the health and safety risks which form the subject of this Article shall be the responsibility of one or more workers, of one service or of separate services whether from inside or outside the undertaking and/or establishment. The worker(s) and/or agency(ies) must work together whenever necessary. 7. Member States may define, in the light of the nature of the activities and size of the undertakings, the categories of undertakings in which the employer, provided he is competent, may himself take responsibility for the measures referred to in paragraph 1. 8. Member States shall define the necessary capabilities and aptitudes referred to in paragraph 5. They may determine the sufficient number referred to in paragraph 5. Article 8 First aid, fire-fighting and evacuation of workers, serious and imminent danger 1. The employer shall: - take the necessary measures for first aid, fire-fighting and evacuation of workers, adapted to the nature of the activities and the size of the undertaking and/or establishment and taking into account other persons present, - arrange any necessary contacts with external services, particularly as regards first aid, emergency medical care, rescue work and fire-fighting. 2. Pursuant to paragraph 1, the employer shall, inter alia, for first aid, fire-fighting and the evacuation of workers, designate the workers required to implement such measures. The number of such workers, their training and the equipment available to them shall be adequate, taking account of the size and/or specific hazards of the undertaking and/or establishment. 3. The employer shall: (a) as soon as possible, inform all workers who are, or may be, exposed to serious and imminent danger of the risk involved and of the steps taken or to be taken as regards protection; (b) take action and give instructions to enable workers in the event of serious, imminent and unavoidable danger to stop work and/or immediately to leave the work place and proceed to a place of safety; (c) save in exceptional cases for reasons duly substantiated, refrain from asking workers to resume work in a working situation where there is still a serious and imminent danger. 4. Workers who, in the event of serious, imminent and unavoidable danger, leave their workstation and/or a dangerous area may not be placed at any disadvantage because of their action and must be protected against any harmful and unjustified consequences, in accordance with national laws and/or practices. 5. The employer shall ensure that all workers are able, in the event of serious and imminent danger to their own safety and/or that of other persons, and where the immediate superior responsible cannot be contacted, to take the appropriate steps in the light of their knowledge and the technical means at their disposal, to avoid the consequences of such danger. Their actions shall not place them at any disadvantage, unless they acted carelessly or there was negligence on their part. Article 9 Various obligations on employers 1. The employer shall: (a) be in possession of an assessment of the risks to safety and health at work, including those facing groups of workers exposed to particular risks; (b) decide on the protective measures to be taken and, if necessary, the protective equipment to be used; (c) keep a list of occupational accidents resulting in a worker being unfit for work for more than three working days; (d) draw up, for the responsible authorities and in accordance with national laws and/or practices, reports on occupational accidents suffered by his workers. 2. Member States shall define, in the light of the nature of the activities and size of the undertakings, the obligations to be met by the different categories of undertakings in respect of the drawing-up of the documents provided for in paragraph 1 (a) and (b) and when preparing the documents provided for in paragraph 1 (c) and (d). Article 10 Worker information 1. The employer shall take appropriate measures so that workers and/or their representatives in the undertaking and/or establishment receive, in accordance with national laws and/or practices which may take account, inter alia, of the size of the undertaking and/or establishment, all the necessary information concerning: (a) the safety and health risks and protective and preventive measures and activities in respect of both the undertaking and/or establishment in general and each type of workstation and/or job; (b) the measures taken pursuant to Article 8 (2). 2. The employer shall take appropriate measures so that employers of workers from any outside undertakings and/or establishments engaged in work in his undertaking and/or establishment receive, in accordance with national laws and/or practices, adequate information concerning the points referred to in paragraph 1 (a) and (b) which is to be provided to the workers in question. 3. The employer shall take appropriate measures so that workers with specific functions in protecting the safety and health of workers, or workers' representatives with specific responsibility for the safety and health of workers shall have access, to carry out their functions and in accordance with national laws and/or practices, to: (a) the risk assessment and protective measures referred to in Article 9 (1) (a) and (b); (b) the list and reports referred to in Article 9 (1) (c) and (d); (c) the information yielded by protective and preventive measures, inspection agencies and bodies responsible for safety and health. Article 11 Consultation and participation of workers 1. Employers shall consult workers and/or their representatives and allow them to take part in discussions on all questions relating to safety and health at work. This presupposes: - the consultation of workers, - the right of workers and/or their representatives to make proposals, - balanced participation in accordance with national laws and/or practices. 2. Workers or workers' representatives with specific responsibility for the safety and health of workers shall take part in a balanced way, in accordance with national laws and/or practices, or shall be consulted in advance and in good time by the employer with regard to: (a) any measure which may substantially affect safety and health; (b) the designation of workers referred to in Articles 7 (1) and 8 (2) and the activities referred to in Article 7 (1); (c) the information referred to in Articles 9 (1) and 10; (d) the enlistment, where appropriate, of the competent services or persons outside the undertaking and/or establishment, as referred to in Article 7 (3); (e) the planning and organization of the training referred to in Article 12. 3. Workers' representatives with specific responsibility for the safety and health of workers shall have the right to ask the employer to take appropriate measures and to submit proposals to him to that end to mitigate hazards for workers and/or to remove sources of danger. 4. The workers referred to in paragraph 2 and the workers' representatives referred to in paragraphs 2 and 3 may not be placed at a disadvantage because of their respective activities referred to in paragraphs 2 and 3. 5. Employers must allow workers' representatives with specific responsibility for the safety and health of workers adequate time off work, without loss of pay, and provide them with the necessary means to enable such representatives to exercise their rights and functions deriving from this Directive. 6. Workers and/or their representatives are entitled to appeal, in accordance with national law and/or practice, to the authority responsible for safety and health protection at work if they consider that the measures taken and the means employed by the employer are inadequate for the purposes of ensuring safety and health at work. Workers' representatives must be given the opportunity to submit their observations during inspection visits by the competent authority. Article 12 Training of workers 1. The employer shall ensure that each worker receives adequate safety and health training, in particular in the form of information and instructions specific to his workstation or job: - on recruitment, - in the event of a transfer or a change of job, - in the event of the introduction of new work equipment or a change in equipment, - in the event of the introduction of any new technology. The training shall be: - adapted to take account of new or changed risks, and - repeated periodically if necessary. 2. The employer shall ensure that workers from outside undertakings and/or establishments engaged in work in his undertaking and/or establishment have in fact received appropriate instructions regarding health and safety risks during their activities in his undertaking and/or establishment. 3. Workers' representatives with a specific role in protecting the safety and health of workers shall be entitled to appropriate training. 4. The training referred to in paragraphs 1 and 3 may not be at the workers' expense or at that of the workers' representatives. The training referred to in paragraph 1 must take place during working hours. The training referred to in paragraph 3 must take place during working hours or in accordance with national practice either within or outside the undertaking and/or the establishment.SECTION III WORKERS' OBLIGATIONS Article 13 1. It shall be the responsibility of each worker to take care as far as possible of his own safety and health and that of other persons affected by his acts or Commissions at work in accordance with his training and the instructions given by his employer. 2. To this end, workers must in particular, in accordance with their training and the instructions given by their employer: (a) make correct use of machinery, apparatus, tools, dangerous substances, transport equipment and other means of production; (b) make correct use of the personal protective equipment supplied to them and, after use, return it to its proper place; (c) refrain from disconnecting, changing or removing arbitrarily safety devices fitted, e.g. to machinery, apparatus, tools, plant and buildings, and use such safety devices correctly; (d) immediately inform the employer and/or the workers with specific responsibility for the safety and health of workers of any work situation they have reasonable grounds for considering represents a serious and immediate danger to safety and health and of any shortcomings in the protection arrangements; (e) cooperate, in accordance with national practice, with the employer and/or workers with specific responsibility for the safety and health of workers, for as long as may be necessary to enable any tasks or requirements imposed by the competent authority to protect the safety and health of workers at work to be carried out; (f) cooperate, in accordance with national practice, with the employer and/or workers with specific responsibility for the safety and health of workers, for as long as may be necessary to enable the employer to ensure that the working environment and working conditions are safe and pose no risk to safety and health within their field of activity. SECTION IV MISCELLANEOUS PROVISIONS Article 14 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, if he so wishes, may receive health surveillance at regular intervals. 3. Health surveillance may be provided as part of a national health system. Article 15 Risk groups Particularly sensitive risk groups must be protected against the dangers which specifically affect them. Article 16 Individual Directives - Amendments - General scope of this Directive 1. The Council, acting on a proposal from the Commission based on Article 118a of the Treaty, shall adopt individual Directives, inter alia, in the areas listed in the Annex. 2. This Directive and, without prejudice to the procedure referred to in Article 17 concerning technical adjustments, the individual Directives may be amended in accordance with the procedure provided for in Article 118a of the Treaty. 3. The provisions of this Directive shall apply in full to all the areas covered by the individual Directives, without prejudice to more stringent and/or specific provisions contained in these individual Directives. Article 17 Committee 1. For the purely technical adjustments to the individual Directives provided for in Article 16 (1) to take account of: - the adoption of Directives in the field of technical harmonization and standardization, and/or - technical progress, changes in international regulations or specifications, and new findings, 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 three months from the date of the referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 18 Final provisions 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 forthwith inform the Commission thereof. 2. 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 covered by this Directive. 3. 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 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. 4. 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 to 3. Article 19 This Directive is addressed to the Member States.

31989L0395

1989

Council Directive 89/395/EEC of 14 June 1989 amending Directive 79/112/EEC on the approximation of the laws of the Member States relating to labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a therof, 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 Council Directive 79/112/EEC (4), as last amended by Directive 86/197/EEC (5), makes provision for national derogations in a number of cases; Whereas, with the dual aim of completing the internal market and providing improved information for all consumers in the Community, those derogations should be eliminated; Whereas, in particular, experience acquired since the adoption of Directive 79/112/EEC enables it to be made applicable to restaurants, hospitals, canteens and other similar mass caterers throughout the Community; Whereas the date of minimum durability has proved its worth; whereas, however, in the interests of a better protection of public health a stricter system of dating should be used in preference thereto in the case of foodstuffs which, from the microbiological point of view, are highly perishable and whereas in doubtful cases a Community procedure should be laid down; Whereas this Directive is concerned only with labelling, presentation and advertising and not with the question of allowing or banning irradiation of foodstuffs or ingredients thereof; Whereas, however, without prejudice to a decision on substance at Community level, the consumer's right to be informed of any irradiation treatment undergone by a foodstuff, where such treatment is allowed, must already be acknowledged; whereas to that end it should be specified that any foodstuff which has undergone such treatment must bear a corresponding indication; whereas, however, specific provisions concerning compound foodstuffs containing an ingredient previously treated with ionizing radiation will not be adopted until rules are adopted on irradiation treatment itself; Whereas with a view to facilitating trade between Member States, it may be provided that, at stages prior to sale to the ultimate consumer, only information on the essential elements should appear on the outer packaging and whereas certain mandatory particulars that must appear on a prepackaged foodstuff need appear only on commercial documents referring thereto; Whereas in all cases where the Council empowers the Commission to implement rules relating to foodstuffs intended for human consumption, provision should be made for a procedure establishing close cooperation between the Member States and the Commission within the Standing Committee for Foodstuffs, set up by Decision 69/414/EEC (6), Article 1 Directive 79/112/EEC is hereby amended as follows: 1. The title of the Directive shall be replaced by the following: 'Council Directive of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs'. 2. Article 1 (2) shall be replaced by the following: '2. This Directive shall apply also to foodstuffs intended for supply to restaurants, hospitals, canteens and other similar mass caterers (hereinafter referred to as "mass caterers").' 3. In Article 1 (3) (b), 'to the ultimate consumer' shall be replaced by 'to the ultimate consumer and to mass caterers'. 4. Article 2 (1) (b) shall be replaced by the following: (b) subject to Community provisions applicable to natural mineral waters and foodstuffs for particular nutritional uses, attribute to any foodstuff the property of preventing, treating or curing a human disease, or refer to such properties'. 5. Article 3 (1) (4) shall be replaced by the following: '4. The date of minimum durability or, in the case of foodstuffs which, from the microbiological point of view, are highly perishable, the "use by" date.' 6. The following paragraph shall be added to Article 4: '3. The Community provisions referred to in paragraphs 1 and 2 shall be adopted in accordance with the procedure laid down in Article 17.' 7. In Article 5 (1), 'to the ultimate consumer' shall be replaced by 'to the ultimate consumer and to mass caterers'. 8. In Article 5 (3) the following text shall be added: 'Any foodstuff which has been treated with ionizing radiation must bear one of the following indications: - in Spanish "irradiado" or "tratado con radiacíon ionizante" - in Danish: "bestraalet/ . . ." or "straalekonserveret" or "behandlet med ioniserende straaling" or "konserveret met ioniserende straaling" - in German: "bestrahlt" or "mit ionisierenden Strahlen behandelt" - in Greek: "epexergasmeno me ionizoysa aktinovolia" or "aktinovolimeno" - in English: "irradiated" or "treated with ionizing radiation" - in French: "traite par rayonnements ionisants" or "traite par ionisation" - in Italian: "irradiato" or "trattato con radiazioni ionizzanti" - in Dutch: "doorstraald" or "door bestraling behandeld" or "met ioniserende stralen behandeld" - in Portuguese: "irradiado" or "tratado por irradiação" or "tratado por radiaçã o ionizante"' 9. The first indent of Article 6 (5) (b) shall be replaced by the following: '- ingredients which belong to one of the categories listed in Annex I and are constituents of another foodstuff may be designated by the name of that category only. Alterations to the list of categories in Annex I may be effected in accordance with the procedure laid down in Article 17,', 10. The following shall be added to the third indent of Article 6 (5) (b): 'These provisions shall be adopted in accordance with the procedure laid down in Article 17,'. 11. The fourth indent of Article 6 (5) (b) shall be replaced by the following: '- the specific community provisions governing the indication of treatment of an ingredient with ionizing radiation shall be adopted subsequently in accordance with Article 100a of the Treaty.' 12. The following subparagraph shall be added to Article 6 (6): 'The community provisions referred to in this paragraph shall be adopted in accordance with the procedure laid down in Article 17.' 13. The following subparagraph shall be added to Article 7 (3): 'The community provisions referred to in this paragraph shall be adopted in accordance with the procedure laid down in Article 17.' 14. Article 8 (4) shall be replaced by the following: '4. Where a solid foodstuff is presented in a liquid medium, the drained net weight of the foodstuff shall also be indicated on the labelling. For the purposes of this paragraph, "liquid medium" shall mean the following products, possibly in mixtures and also where frozen or quick-frozen, provided that the liquid is merely an adjunct to the essential elements of that preparation and is thus not a decisive factor for the purchase: water, aqueous solutions of salts, brine; aqueous solutions of food acids, vinegar; aqueous solutions of sugars, aqueous solutions of other sweetening substances; fruit or vegetable juices in the case of fruit or vegetables. This list may be supplemented in accordance with the procedure laid down in Article 17. Methods of checking the drained net weight shall be determined in accordance with the procedure laid down in Article 17.' 15. The following paragraph shall be added to Article 8: '7. The community provisions referred to in paragraphs 1, 2 (b) and (d) and 5 shall be adopted in accordance with the procedure laid down in Article 17.' 16. The second and third subparagraphs of Article 9 (2) shall be deleted. 17. Article 9 (5) shall be replaced by the following: '5. In their own territories the Member States may, until 31 December 1992, permit the minimum durability period to be expressed otherwise than in terms of the date of minimum durability. Without prejudice to the notification provided for in Article 22, Member States shall notify the commission and the other Member States of any measure taken under this paragraph.' 18. Article 9 (6) shall be replaced by the following: '6. Subject to community provisions imposing other types of date indication, an indication of the durability date shall not be required for: - fresh fruit and vegetables, including potatoes, which have not been peeled, cut or similarly treated. This derogation shall not apply to sprouting seeds and similar products such as legume sprouts, - wines, liqueur wines, sparkling wines, aromatized wines and similar products obtained from fruits other than grapes, and beverages falling within cN codes 2206 00 91, 2206 00 93 and 2206 00 99 and manufactured from grapes or grape musts, - beverages containing 10 % or more by volume of alcohol, - soft drinks, fruit juices, fruit nectars and alcoholic beverages in individual containers of more than five litres, intended for supply to mass caterers, - bakers' or pastry cooks' wares which, given the nature of their content, are normally consumed within 24 hours of their manufacture, - vinegar, - cooking salt, - solid sugar, - confectionery products consisting almost solely of flavoured and/or coloured sugars, - chewing gums and similar chewing products. - individual portions of ice-cream.' 19. The following Article shall be added: 'Article 9a 1. In the case of foodstuffs which, from the microbiological point of view, are highly perishable and are therefore likely after a short period to constitute an immediate danger to human health, the date of minimum durability shall be replaced by the "use by" date. 2. The date shall be preceded by the words: - in Spanish: "fecha de caducidad", - in Danish: "sidste anvendelsesdato", - in German: "verbrauchen bis", - in Greek: "analosi mechri", - in English: "use by", - in French: "à consommer jusqu'au", - in Italian: "da consumare entro", - in Dutch: "te gebruiken tot", - in Portuguese: "a consumir até". These words shall be accompanied by: - either the date itself, or - a reference to where the date is given on the labelling. These particulars shall be followed by a description of the storage conditions which must be observed. 3. The date shall consist of the day, the month and, possibly, the year, in that order and in uncoded form. 4. In some cases it may be decided by the procedure laid down in Article 17 whether the conditions laid down in paragraph 1 are fulfilled.' 20. The following subparagraph shall be added to Article 10 (2): 'The Community provisions referred to in this paragraph shall be adopted in accordance with the procedure laid down in Article 17.' 21. Article 11 shall be replaced by the following: 'Article 11 1. (a) When the foodstuffs are prepackaged, the particulars provided for in Articles 3 and 4 (2) shall appear on the prepackaging or on a label attached thereto. (b) Notwithstanding point (a) and without prejudice to Community provisions on nominal quantities, where prepackaged foodstuffs are: - intended for the ultimate consumer but marketed at a stage prior to sale to the ultimate consumer and where sale to a mass caterer is not involved at that stage, - intended for supply to mass caterers for preparation, processing, splitting or retail sale, the particulars required under Articles 3 and 4 (2) need appear only on the commercial documents referring to the foodstuffs where it can be guaranteed that such documents, containing all the labelling information, either accompany the foodstuffs to which they refer or were sent before or at the same time as delivery. (c) In the cases referred to in (b), the particulars referred to in Article 3 (1) (1), (4) and (6) and, where appropriate, that referred to in Article 9a, shall also appear on the external packaging in which the foodstuffs are presented for marketing. 2. These particulars shall be easy to understand and marked in a conspicuous place in such a way as to be easily visible, clearly legible and indelible. They shall not in any way be hidden, obscured or interrupted by other written or pictorial matter. 3. (a) The particulars listed in Article 3 (1), points 1, 3, 4 and 9 shall appear in the same field of vision. This requirement may be extended to the particulars provided for in Article 4 (2). (b) However, for glass bottles intended for re-use, upon which one of the particulars listed in point (a) is indelibly marked, this requirement shall not apply for a period of 10 years following notification of this Directive. 4. In the case of the glass bottles intended for re-use which are indelibly marked and which therefore bear no label, ring or collar and packaging or containers the largest surface of which has an area of less than 10 cm$ only the particulars listed in Article 3 (1) (1), (3) and (4) need be given. In this case, paragraph 3 (a) shall not apply. 5. Member States may, until 31 December 1996, refrain from requiring the minimum durability date or the "use by" date to be mentioned in respect of bottles referred to in paragraph 4. 6. Ireland, the Netherlands and the United Kingdom may derogate from Article 3 (1) and paragraph 3 (a) of this Article in the case of milk and milk products put up in glass bottles intended for re-use. 7. The Member States shall inform the Commission of any measure taken pursuant to paragraphs 5 or 6.' 22. In the first paragraph of Article 12, 'to the ultimate consumer' shall be replaced by 'to the ultimate consumer or to mass caterers'. 23. In the second paragraph of Article 12, 'consumer' shall be replaced by 'purchaser'. 24. Article 17 shall be replaced by the following: 'Article 17 Where the procedure laid down in this Article is to be followed, the matter shall be referred to the Standing Committee on Foodstuffs (hereinafter called "the Committee") by its chairman, either on his own initiative or at the request of a representative of a Member State. 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 three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.' 25. Article 18 shall be deleted. 26. Article 23 shall be deleted. Article 2 Member States shall, where necessary, amend their laws, regulations and administrative provisions in such a way as to: - permit trade in products complying with this Directive by not later than 20 December 1990, - prohibit trade in products not complying with this Directive with effect from 20 June 1992. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31989L0381

1989

Council Directive 89/381/EEC of 14 June 1989 extending 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 proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human plasma 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 disparities in the laws, regulations or administrative provisions of Member States may hinder trade in medicinal products derived from human blood or human plasma within the Community; Whereas the essential aim of any rules governing the production, distribution or use of medicinal products must be to ensure a high level of protection of public health; Whereas the provisions laid down by Directive 65/65/EEC (4), as last amended by Directive 87/21/EEC (5), and by Directive 75/319/EEC (6), as last amended by Directive 83/570/EEC (7), both concerning the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, although appropriate, are inadequate with regard to medicinal products derived from human blood or human plasma; Whereas in accordance with Article 5 of Council Directive 87/22/EEC of 22 December 1986 on the approximation of national provisions relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology (8); the Commission is required to submit proposals to harmonize, along the lines of Directive 75/319/EEC, the conditions for authorizing the manufacture and placing on the market of medicinal products derived from human blood or human plasma; Whereas the Community entirely supports the efforts of the Council of Europe to promote voluntary unpaid blood and plasma donation to attain self-sufficiency throughout the Community in the supply of blood products, and to ensure respect for ethical principles in trade in therapeutic substances of human origin; Whereas the rules designed to guarantee the quality, safety and efficacy of medicinal products derived from human blood or human plasma must be applied in the same manner to both public and private establishments, and to blood and plasma imported from third countries; Whereas, before an authorization to market a medicinal product derived from human blood or human plasma can be granted, the manufacturer must demonstrate his ability to guarantee batch-to-batch consistency and the absence of specific viral contamination, to the extent that the state of technology permits; Whereas the Commission should be empowered to adopt, in close cooperation with the Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in Medicinal Products, any necessary changes in the requirements for the testing of proprietary medicinal products set out in the Annex to 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 (1), as last amended by Directive 87/19/EEC (2), to take account of the special nature of medicinal products derived from human blood or human plasma so as to ensure a higher level of quality, safety and efficacy, Article 1 1. By way of derogation from Article 34 of Directive 75/319/EEC, and subject to the provisions of this Directive, Directives 65/65/EEC and 75/319/EEC shall aplly to medicinal products based on blood constituents which are prepared industrially by public or private establishments, hereinafter referred to as 'medicinal products derived from human blood or human plasma'; these medicinal products include, in particular albumin, coagulating factors and immunoglobulins of human origin. 2. This Directive shall not apply to whole blood, to plasma or to blood cells of human origin. 3. This Directive shall be without prejudice to Council Decision 86/346/EEC of 25 June 1986 accepting on behalf of the Community the European Agreement relating to the Exchange of Therapeutic Substances of Human Origin (3). Article 2 1. The quantitative particulars of a medicinal product derived from human blood or human plasma shall be expressed by mass or by international units or by units of biological activity as appropriate to the product concerned. 2. In Directives 65/65/EEC and 75/319/EEC the expressions 'qualitative and quantitative particulars of the constituents' shall include particulars relating to biological activity and 'qualitative and quantitative composition' shall include the composition of the product expressed in terms of biological activity. 3. In any document drawn up for the purposes of this Directive, where the name of a medicinal product derived from human blood or human plasma is expressed, the common or scientific name of the active constituents shall also be included at least once; it may be abbreviated in the remaining references. Article 3 In respect of the use of human blood or human plasma as a starting material for the manufacture of medicinal products: 1. Member States shall take the necessary measures to prevent the transmission of infectious diseases. Insofar as this is covered by the amendments referred to in Article 6, as well as the application of the monographs of the European Pharmacopoeia regarding blood and plasma, these measures shall comprise those recommended by the Council of Europe and the World Health Organization, particularly with reference to the selection and testing of blood and plasma donors; 2. Member States shall take the necessary measures to ensure that human blood and human plasma donors and donation centres are always clearly identifiable; 3. All the safety guarantees referred to in paragraphs 1 and 2 must also be given by importers of human blood or human plasma from third countries; 4. Member States shall take the necessary measures to promote Community self-sufficiency in human blood or human plasma. For this purpose, they shall encourage the voluntary unpaid donation of blood and plasma and shall take the necessary measures to develop the production and use of products derived from human blood or human plasma coming from voluntary unpaid donations. They shall notify the Commission of such measures. Article 4 1. Member States shall take all necessary measures to ensure that the manufacturing and purifying processes used in the preparation of medicinal products derived from human blood or human plasma are properly validated, attain batch-to-batch consistency and guarantee, insofar as the state of technology permits, the absence of specific viral contamination. To this end manufacturers shall notify the competent authorities of the method used to reduce or eliminate pathogenic viruses liable to be transmitted by medicinal products derived from human blood or human plasma. The ocmpetent authority may submit samples of the bulk and/or finished product for testing by a State laboratory or a laboratory designated for that purpose, either during the examination of the application pursuant to Article 4 of Directive 75/319/EEC, or after a marketing authorization has been granted. 2. For the purpose of implementing Article 8 of Directive 65/65/EEC and Article 27 of Directive 75/319/EEC, Member States may require manufacturers of medicinal products derived from human blood or human plasma to submit to a competent authority copies of all the control reports signed by the qualified person, in accordance with Article 22 of Directive 75/319/EEC. 3. Where, in the interests of public health, the laws of a Member State so provide, the competent authorities may require persons responsible for marketing medicinal products derived from human blood or human plasma to submit samples from each batch of the bulk and/or finished product for testing by a State laboratory or a laboratory designated for that purpose before being released into free circulation, unless the competent authorities of another Member State have previously examined the batch in question and declared it to be in conformity with the approved specifications. Member States shall ensure that any such examination is completed within sixty days of the receipt of the samples. Article 5 The procedure laid down in Directive 87/22/EEC shall be extended as necessary to cover medicinal products derived from human blood or human plasma. Article 6 Any necessary amendments to the testing requirements for medicinal products set out in the Annex to Directive 75/318/EEC to take account of the extension of the scope of Directives 65/65/EEC and 75/319/EEC to cover medicinal products derived from human blood or human plasma shall be adopted in accordance with the procedure laid down in Article 2c of Directive 75/318/EEC. Article 7 1. Save in the case provided for in paragraph 2, Member States shall take the necessary measures to comply with this Directive before 1 January 1992. They shall forthwith inform the Commission thereof. 2. In the event of the amendments to Directive 75/318/EEC referred to in Article 6 not being adopted by the date referred to in paragraph 1, this date shall be replaced by the date of adoption of the said amendments. 3. Requests for marketing authorization for the products concerned lodged after the date of application of this Directive shall comply with the provisions thereof. 4. This Directive shall be progressively extended, before 31 December 1992, to existing medicinal products derived from human blood or human plasma, referred to in Article 1 (1). Article 8 This Directive is addressed to the Member States.

31989L0392

1989

Council Directive 89/392/EEC of 14 June 1989 on the approximation of the laws of the Member States relating to machinery /* Codified version CF 398L0037 */ 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 Member States are responsible for ensuring the health and safety on their territory of their people and, where appropriate, of domestic animals and goods and, in particular, of workers notably in relation to the risks arising out of the use of machinery; Whereas, in the Member States, the legislative systems regarding accident prevention are very different; whereas the relevant compulsory provisions, frequently supplemented by de facto mandatory technical specifications and/or voluntary standards, do not necessarily lead to different levels of health and safety, but nevertheless, owing to their disparities, constitute barriers to trade within the Community; whereas, furthermore, conformity certification and national certification systems for machinery differ considerably; Whereas the maintenance or improvement of the level of safety attained by the Member States constitutes one of the essential aims of this Directive and of the principle of safety as defined by the essential requirements; Whereas existing national health and safety provisions providing protection against the risks caused by machinery must be approximated to ensure free movement of machinery without lowering existing justified levels of protection in the Member States; whereas the provisions of this Directive concerning the design and construction of machinery, essential for a safer working environment shall be accompanied by specific provisions concerning the prevention of certain risks to which workers can be exposed at work, as well as by provisions based on the organization of safety of workers in the working environment; Whereas the machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the Community economy; Whereas paragraphs 65 and 68 of the White Paper on the completion of the internal market, approved by the European Council in June 1985, provide for a new approach to legislative harmonization; Whereas the social cost of the large number of accidents caused directly by the use of machinery can be reduced by inherently safe design and construction of machinery and by proper installations and maintenance; Whereas the field of application of this Directive must be based on a general definition of the term 'machinery' so as to allow the technical development of products; whereas the development of 'complex installations' and the risks they involve are of an equivalent nature and their express inclusion in the Directive is therefore justified; Whereas specific Directives containing design and construction provisions for certain categories of machinery are now envisaged; whereas the very broad scope of this Directive must be limited in relation to these Directives and also existing Directives where they contain design and construction provisions; Whereas Community law, in its present form, provides - by way of derogation from one of the fundamental rules of the Community, namely the free movement of goods - that obstacles to movement within the Community resulting from disparities in national legislation relating to the marketing of products must be accepted in so far as the provisions concerned can be recognized as being necessary to satisfy imperative requirements; whereas, therefore, the harmonization of laws in this case must be limited only to those requirements necessary to satisfy the imperative and essential health and safety requirements relating to machinery; whereas these requirements must replace the relevant national provisions because they are essential; Whereas the essential health and safety requirements must be observed in order to ensure that machinery is safe; whereas these requirements must be applied with discernment to take account of the state of the art at the time of construction and of technical and economic requirements; Whereas the putting into service of machinery within the meaning of this Directive can relate only to the use of the machinery itself as intended by the manufacturer; whereas this does not preclude the laying-down of conditions of use external to the machinery, provided that it is not thereby modified in a way not specified in this Directive; Whereas, for trade fairs, exhibitions, etc., it must be possible to exhibit machinery which does not conform to this Directive; whereas, however, interested parties should be properly informed that the machinery does not conform and cannot be purchased in that condition; Whereas, therefore, this Directive defines only the essential health and safety requirements of general application, supplemented by a number of more specific requirements for certain categories of machinery; whereas, in order to help manufacturers to prove conformity to these essential requirements and in order to allow inspection for conformity to the essential requirements, it is desirable to have standards harmonized at European level for the prevention of risks arising out of the design and construction of machinery; whereas these standards harmonized at European level are drawn up by private-law bodies and must retain their non-binding status; whereas for this purpose the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are the bodies recognized as competent to adopt harmonized standards in accordance with the general guidelines for cooperation between the Commission and these two bodies signed on 13 November 1984; whereas, within the meaning of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted by either or both of these bodies, on the basis of a remit from the Commission in accordance with the provisions of Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (4), as last amended by Directive 88/182/EEC (5), and on the basis of general guidelines referred to above; Whereas the legislative framework needs to be improved in order to ensure an effective and appropriate contribution by employers and employees to the standardization process; whereas such improvement should be completed at the latest by the time this Directive is implemented; Whereas, as is currently the practice in Member States, manufacturers should retain the responsibility for certifying the conformity of their machinery to the relevant essential requirements; whereas conformity to harmonized standards creates a presumption of conformity to the relevant essential requirements; whereas it is left to the sole discretion of the manufacturer, where he feels the need, to have his products examined and certified by a third party; Whereas, for certain types of machinery having a higher risk factor, a stricter certification procedure is desirable; whereas the EC type-examination procedure adopted may result in an EC declaration being given by the manufacturer without any stricter requirement such as a guarantee of quality, EC verification or EC supervision; Whereas it is essential that, before issuing an EC declaration of conformity, the manufacturer or his authorized representative established in the Community should provide a technical construction file; whereas it is not, however, essential that all documentation be permanently available in a material manner but it must be made available on demand; whereas it need not include detailed plans of the sub-assemblies used in manufacturing the machines, unless knowledge of these is indispensable in order to ascertain conformity with essential safety requirements; Whereas it is necessary not only to ensure the free movement and putting into service of machinery bearing the EC mark and having an EC conformity certificate but also to ensure free movement of machinery not bearing the EC mark where it is to be incorporated into other machinery or assembled with other machinery to form a complex installation; Whereas the Member States' responsibility for safety, health and the other aspects covered by the essential requirements on their territory must be recognized in a safeguard clause providing for adequate Community protection procedures; Whereas the addresses of any decision taken under this Directive must be informed on the reasons for such a decision and the legal remedies open to them; Whereas the measures aimed at the gradual establishment of the internal market must be adopted by 31 December 1992; whereas the internal market consists of an area without internal frontiers within which the free movement of goods, persons, services and capital is guaranteed, CHAPTER I SCOPE, PLACING ON THE MARKET AND FREEDOM OF MOVEMENT Article 1 1. This Directive applies to machinery and lays down the essential health and safety requirements therefor, as defined in Annex I. 2. For the purposes of this Directive, 'machinery' means an assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control and power circuits, etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material. The term 'machinery' also covers an assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole. 3. The following are excluded from the scope of this Directive: - mobile equipment, - lifting equipment, - machinery whose only power source is directly applied manual effort, - machinery for medical use used in direct contact with patients, - special equipment for use in fairgrounds and/or amusement parks, - steam boilers, tanks and pressure vessels, - machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity, - radioactive sources forming part of a machine, - firearms, - storage tanks and pipelines for petrol, diesel fuel, inflammable liquids and dangerous substances. 4. Where, for machinery, the risks referred to in this Directive are wholly or partly covered by specific Community Directives, this Directive shall not apply, or shall cease to apply, in the case of such machinery and of such risks on the entry into force of these specific Directives. 5. Where, for machinery, the risks are mainly of electrical origin, such machinery shall be covered exclusively by Council Directive 73/23/EEC of 19 February 1973 on the harmonization of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits (6). Article 2 1. Member States shall take all appropriate measures to ensure that machinery covered by this Directive may be placed on the market and put into service only if it does not endanger the health or safety of persons and, where appropriate, domestic animals or property, when properly installed and maintained and used for its intended purpose. 2. The provisions of this Directive shall not affect Member States' entitlement to lay down, in due observance of the Treaty, such requirements as they may deem necessary to ensure that persons and in particular workers are protected when using the machines in question, provided that this does not mean that the machinery is modified in a way not specified in the Directive. 3. At trade fairs, exhibitions, demonstrations, etc., Member States shall not prevent the showing of machinery which does not conform to the provisions of this Directive, provided that a visible sign clearly indicates that such machinery does not conform and that it is not for sale until it has been brought into conformity by the manufacturer or his authorized representative established in the Community. During demonstrations, adequate safety measures shall be taken to ensure the protection of persons. Article 3 Machinery covered by this Directive shall satisfy the essential health and safety requirements set out in Annex I. Article 4 1. Member States shall not prohibit, restrict or impede the placing on the market and putting into service in their territory of machinery which complies with the provisions of this Directive. 2. Member States shall not prohibit, restrict or impede the placing on the market of machinery where the manufacturer or his authorized representative established in the Community declares in accordance with Annex II.B that it is intended to be incorporated into machinery or assembled with other machinery to constitute machinery covered by this Directive except where it can function independently. Article 5 1. Member States shall regard machinery bearing the EC mark and accompanied by the EC declaration of conformity referred to in Annex II as conforming to the essential health and safety requirements referred to in Article 3. In the absence of harmonized standards, Member States shall take any steps they deem necessary to bring to the attention of the parties concerned the existing national technical standards and specifications which are regarded as important or relevant to the proper implementation of the essential safety and health requirements in Annex I. 2. Where a national standard transposing a harmonized standard, the reference for which has been published in the Official Journal of the European Communities, covers one or more of the essential safety requirements, machinery constructed in accordance with this standard shall be presumed to comply with the relevant essential requirements. Member States shall publish the references of national standards transposing harmonized standards. 3. Member States shall ensure that appropriate measures are taken to enable the social partners to have an influence at national level on the process of preparing and monitoring the harmonized standards. Article 6 1. Where a Member State or the Commission considers that the harmonized standards referred to in Article 5 (2) do not entirely satisfy the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the Committee set up under Directive 83/189/EEC, giving the reasons therefor. The Committee shall deliver an opinion without delay. Upon receipt of the Committee's opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw those standards from the published information referred to in Article 5 (2). 2. A standing committee shall be set up, consisting of representatives appointed by the Member States and chaired by a representative of the Commission. The standing committee shall draw up its own rules of procedure. Any matter relating to the implementation and practical application of this Directive may be brought before the standing committee, in accordance with the following procedure: 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 1. Where a Member State ascertains that machinery bearing the EC mark and used in accordance with its intended purpose is liable to endanger the safety of persons, and, where appropriate, domestic animals or property, it shall take all appropriate measures to withdraw such machinery from the market, to prohibit the placing on the market, putting into service or use thereof, or to restrict free movement thereof. The Member State shall immediately inform the Commission of any such measure, indicating the reasons for its decision and, in particular, whether non-conformity is due to: (a) failure to satisfy the essential requirements referred to in Article 3; (b) incorrect application of the standards referred to in Article 5 (2); (c) shortcomings in the standards referred to in Article 5 (2) themselves. 2. The Commission shall enter into consultation with the parties concerned without delay. Where the Commission considers, after this consultation, that the measure is justified, it shall immediately so inform the Member State which took the initiative and the other Member States. Where the Commission considers, after this consultation, that the action is unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorized representative established within the Community. Where the decision referred to in paragraph 1 is based on a shortcoming in the standards, and where the Member State at the origin of the decision maintains its position, the Commission shall immediately inform the Committee in order to initiate the procedures referred to in Article 6 (1). 3. Where machinery which does not comply bears the EC mark, the competent Member State shall take appropriate action against whomsoever has affixed the mark and shall so inform the Commission and the other Member States. 4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure. CHAPTER II CERTIFICATION PROCEDURE Article 8 1. The manufacturer, or his authorized representative established in the Community, shall, in order to certify the conformity of machinery with the provisions of this Directive, draw up an EC declaration of conformity based on the model given in Annex II for each machine manufactured and shall affix to the machinery the EC mark referred to in Article 10. 2. Before placing on the market, the manufacturer, or his authorized representative established in the Community, shall: (a) if the machinery is not referred to in Annex IV, draw up the file provided for in Annex V; (b) if the machinery is referred to in Annex IV and its manufacturer does not comply, or only partly complies, with the standards referred to in Article 5 (2) or if there are no such standards, submit an example of the machinery for the EC type-examination referred to in Annex VI; (c) if the machinery is referred to in Annex IV and is manufactured in accordance with the standards referred to in Article 5 (2): - either draw up the file referred to in Annex VI and forward it to a notified body, which will acknowledge receipt of the file as soon as possible and keep it, - submit the file referred to in Annex VI to the notified body, which will simply verify that the standards referred to in Article 5 (2) have been correctly applied and will draw up a certificate of adequacy for the file, - or submit the example of the machinery for the EC type-exmination referred to in Annex VI. 3. Where the first indent of paragraph 2 (c) applies, the provisions of the first sentence of paragraph 5 and paragraph 7 of Annex VI shall also apply. Where the second indent of 2 (c) applies, the provisions of paragraphs 5, 6 and 7 of Annex VI shall also apply. 4. Where paragraph 2 (a) and the first and second indents of paragraph 2 (c) apply, the EC declaration of conformity shall solely state conformity with the essential requirements of the Directive. Where paragraph 2 (b) and (c) apply, the EC declaration of conformity shall state conformity with the example that underwent EC type-examination. 5. Whre the machinery is subject to other Community Directives concerning other aspects, the EC mark referred to in Article 10 shall indicate in these cases that the machinery also fulfils the requirements of the other Directives. 6. Where neither the manufacturer nor his authorized representative established in the Community fulfils the obligations of the preceding paragraphs, these obligations shall fall to any person placing the machinery on the market in the Community. The same obligations shall apply to any person assembling machinery or parts thereof of various origins or constructing machinery for his own use. Article 9 1. Each Member State shall notify the Commission and the other Member States of the approved bodies responsible for carrying out the certification procedures referred to in Article 8 (2) (b) and (c). The Commission shall publish a list of these bodies in the Official Journal of the European Communities for information and shall ensure that the list is kept up to date. 2. Member States shall apply the criteria laid down in Annex VII in assessing the bodies to be indicated in such notification. Bodies meeting the assessment criteria laid down in the relevant harmonized standards shall be presumed to fulfil those criteria. 3. A Member State which has approved a body must withdraw its notification if it finds that the body no longer meets the criteria referred to in Annex VII. It shall immediately inform the Commission and the other Member States accordingly. CHAPTER III EC MARK Article 10 1. The 'EC' mark shall consist of the EC symbol followed by the last two digits of the year in which the mark was affixed. Annex III shows the model to be used. 2. The EC mark shall be affixed to machinery distinctly and visibly in accordance with point 1.7.3 of Annex I. 3. Marks or inscriptions liable to be confused with the EC mark shall not be put on machinery.CHAPTER IV FINAL PROVISIONS Article 11 Any decision taken pursuant to this Directive which restricts the marketing and putting into service of machinery shall state the exact grounds on which it is based. Such a decision shall be notified as soon as possible to the party concerned, who shall at the same time be informed of the legal remedies available to him under the laws in force in the Member State concerned and of the time limits to which such remedies are subject. Article 12 The Commission will take the necessary steps to have information on all the relevant decisions relating to the management of this Directive made available. Article 13 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary in order to comply with this Directive by 1 January 1992 at the latest. They shall forthwith inform the Commission thereof. They shall apply these provisions with effect from 31 December 1992. 2. Member States shall ensure that the texts of the provisions of national law which they adopt in the field covered by this Directive are communicated to the Commission. Article 14 This Directive is addressed to the Member States.

31989L0397

1989

Council Directive 89/397/EEC of 14 June 1989 on the official control of foodstuffs 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 trade in foodstuffs is one of the most important aspects of the common market; whereas all the Member States must endeavour to protect the health and economic interests of their citizens; whereas the protection of health must be given unconditional priority and whereas, therefore, official control of foodstuffs must be harmonized and made more effective; Whereas, however, the differences between national legislations with respect to this type of control are such as to represent barriers to the free movement of goods; Whereas it is therefore necessary to approximate these legislations; Whereas, first of all, the general principles governing the carrying-out of such control must be harmonized; Whereas specific provisions, in addition to the general principles, may, if necessary, be adopted subsequently; Whereas the subject of this Directive is verification of the compliance of foodstuffs with legislation on foodstuffs; whereas such legislation contains provisions on health, rules on composition and rules on quality designed to protect consumers' economic interests as well as provisions on consumer information and fair commercial transactions; Whereas, at the same time as foodstuffs, materials and articles intended to come into contact with such foodstuffs should be controlled; Whereas for the purposes of the completion of the internal market, foodstuffs intended to cross intra-Community frontiers must be inspected with the same care as those intended for marketing in the Member State of production; Whereas inspection must therefore be based in principle on the provisions in force in the Member State of production; whereas, however, such a principle should not apply where it has been established to the the satisfaction of the inspecting authority by appropriate means, including the submission of commercial documents, that the product in question is intended for consignment to another Member State and that it complies with the provisions in force in that Member State; Whereas, to be effective, inspections must be carried out regularly; whereas they must not be limited as to the subject, stage or moment at which it is convenient to carry them out, and whereas they must take the most suitable forms to guarantee their effectiveness; Whereas in order to ensure that inspection procedures are not evaded, it is necessary to provide that Member States shall not exclude a product from appropriate inspection on the grounds that it is intended for export outside the Community; Whereas the inspectors must be granted adequate powers; Whereas although, on the one hand, undertakings should not have the right to oppose the inspections, on the other hand their legitimate rights must be preserved, in particular the right to manufacturing secrecy and the right of appeal; Whereas the authorities made responsible for the control of foodstuffs may differ from one Member State to another; whereas it is, therefore, desirable to publish a list of the competent authorities in the field in each Member State, with an indication of the territories for which they are competent, and approved laboratories for the analyses to be carried out in connection with such control; Whereas official controls should contribute effectively to the prevention of food law infringements; whereas to that end programmes should be drawn up on the basis of appropriate criteria; Whereas, although it is primarily for Member States to lay down their inspection programmes, it is necessary, with a view to the completion and operation of the internal market, to arrange also for coordinated programmes at Community level; Whereas simultaneous implementation of national programmes and coordinated programmes will provide experience which is still widely lacking at present; whereas, in the light of that experience, it may prove necessary to revise this Directive to improve the arrangements which it introduces; Whereas Member States should be allowed a certain degree of freedom as to the practical means of carrying out inspections so as not to interfere with systems of proven worth which are best suited to the particular situation in each Member State, Article 1 1. This Directive lays down the general principles for the performance of official control of foodstuffs. 2. For the purposes of this Directive 'official control of foodstuffs' - hereinafter called 'control' - means an inspection by the competent authorities of the compliance: - of foodstuffs, - of food additives, vitamins, mineral salts, trace elements and other additives intended to be sold as such, - of materials and articles intended to come into contact with foodstuffs, with provisions aimed at preventing risks to public health, guaranteeing fair commercial transactions or protecting consumer interests, including provisions on consumer information. 3. This Directive shall apply without prejudice to the provisions adopted in the context of more specific Community rules. 4. This Directive shall not apply to metrological control. Article 2 1. Member States shall take all necessary measures to ensure that control is carried out in accordance with this Directive. 2. Member States shall ensure that products intended for consignment to another Member State are inspected with the same care as those intended for marketing on their own territory. Article 3 Member States shall not exclude a product from appropriate control on the grounds that it is intended for export outside the Community. Article 4 1. Inspections shall be carried out: (a) regularly; (b) where non-compliance is suspected. 2. Inspections shall be carried out using means proportionate to the end to be observed. 3. Inspection shall cover all stages of production, manufacture, import into the Community, processing, storage, transport, distribution and trade. 4. As a general rule, inspections shall be carried out without prior warning. 5. As a general rule, inspections shall, in each case, select the stage or stages which it considers the most appropriate for its examination from those listed in paragraph 3. Article 5 Control shall comprise one or more of the following operations in accordance with the conditions laid down in Articles 6 to 9 and in the light of the examination to be carried out: 1. inspection; 2. sampling and analysis; 3. inspection of staff hygiene; 4. examination of written and documentary material; 5. examination of any verification systems set up by the undertaking and of the results obtained. Article 6 1. The following shall be subject to inspection: (a) the state and use which is made at the different stages enumerated in Article 4 (3) of the site, premises, offices, plant surroundings, means of transport, machinery and equipment; (b) raw materials, ingredients, technological aids and other products used for the preparation and production of foodstuffs; (c) semi-finished products; (d) finished products; (e) materials and articles intended to come into contact with foodstuffs; (f) cleaning and maintenance products and processes and pesticides; (g) processes used for the manufacture or processing of foodstuffs; (h) labelling and presentation of foodstuffs; (i) preserving methods. 2. The operations enumerated in paragraph 1 may, where necessary, be supplemented by: - interviews with the head of the inspected undertaking and with persons working for that undertaking, - the reading of values recorded by measuring instruments installed by the undertaking, - inspections carried out by the competent authority, with its own instruments, of measurements taken with the instruments installed by the undertaking. Article 7 1. Samples of the products enumerated in Article 6 (1) (b) to (f) may be taken for the purposes of analysis. Member States shall take the necessary steps to ensure that those subject to inspection may apply for a second opinion. 2. The analyses shall be carried out by official laboratories. Member States may also empower other laboratories to carry out these analyses. Article 8 Persons who, in the exercise of their activity, come into contact, whether directly or indirectly, with the materials and products referred to in Article 6 (1) (b) to (f) shall be subject to the hygiene inspection referred to in Article 5 (3). The purpose of this inspection shall be to check that the health standards concerning personal cleanliness and clothing are respected. It shall be carried out without prejudice to medical examinations. Article 9 1. Inspectors may take note of written and documentary material held by the natural and legal persons at the various stages enumerated in Article 4 (3). 2. Inspectors may also make copies or take extracts of written and documentary material submitted to them for examination. Article 10 Where inspectors discover or suspect an irregularity, they shall take the requisite measures. Article 11 1. Member States shall ensure that inspectors have the right to carry out the operations provided for in Articles 6 to 10. 2. Member States shall prescribe that the natural and legal persons concerned shall be obliged to undergo any inspection carried out in accordance with this Directive and to assist inspectors in the accomplishment of their tasks. Article 12 1. Member States shall take the measures necessary to ensure that natural and legal persons concerned by the inspection have a right of appeal against measures taken by the competent authority for the purpose of inspection. 2. They shall prescribe that inspectors shall be bound by professional secrecy. Article 13 In order to ensure that the application of this Directive is uniform throughout the Member States, the Commission shall, within one year of its adoption, make a report to the European Parliament and to the Council on: (a) the current standard of training provision for food inspectors in the Member States; (b) the possibility of establishing Community provisions on what should constitute the basic and further training of inspectors; (c) the possibility of establishing Community quality standards for all laboratories involved in inspection and sampling under this Directive; (d) the possibility of establishing a Community inspection service, including opportunities for all institutions and persons involved in the inspections to exchange information. Article 14 1. The competent authority or authorities of the Member States shall draw up forward programmes laying down the nature and frequency of the inspections to be carried out regularly in accordance with Article 4 (1) (a) over a specific period. 2. By 1 May of each year the Member States shall send to the Commission all the necessary information on implementation during the previous year of the programmes referred to in paragraph 1, specifying: - the criteria applied in drawing up these programmes, - the number and type of inspections carried out, - the number and type of infringements established. 3. By 16 October of each year, and for the first time in 1991, the Commission shall transmit to the Member States, after having consulted them within the framework of the Standing Committee for Foodstuffs, a recommendation concerning a coordinated programme of inspections for the following year. This recommendation may be subsequently adjusted as required during implementation of the coordinated programme. The coordinated programme shall set out in particular the priority criteria to be applied in its implementation. The information provided for in paragraph 2 shall contain a special, separate section on implementation of the coordinated programme. 4. Five years after notification of this Directive the Commission shall transmit to the Council a report on the application of this Article, accompanied, if necessary, by any appropriate proposals. Article 15 Each Member State shall communicate to the Commission the names of: - the competent authority or authorities and the extent of their territorial responsibility and functions, - the official laboratories or laboratories authorized by the competent authorities, which are responsible for carrying out analyses in connection with the control. These lists shall be published in the 'C' series of the Official Journal of the European Communities. Article 16 Member States shall adopt and publish, not later than 12 months after notification of this Directive, the laws, regulations and administrative provisions necessary to comply with this Directive not later than 24 months after its notification (4). They shall forthwith inform the Commission thereof. Article 17 This Directive is addressed to the Member States.

31989L0396

1989

Council Directive 89/396/EEC of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs 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 necessary to adopt measures with the aim of progressively establishing the internal market over the 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 trade in foodstuffs occupies a very important place in the internal market; Whereas indication of the lot to which a foodstuff belongs meets the need for better information on the identity of products; whereas it is therefore a useful source of information when foodstuffs are the subject of dispute or constitute a health hazard for consumers; 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 (4), as last amended by Directive 89/395/EEC (5), contains no provisions on indication of lot identification; whereas some Member States have meanwhile adopted national measures requiring such indication; Whereas at international level there is now a general obligation to provide a reference to the manufacturing or packaging lot of prepackaged foodstuffs; whereas it is the Community's duty to contribute to the development of international trade; Whereas it is therefore advisable to adopt rules of a general and horizontal nature in order to establish a common lot identification system; Whereas the efficiency of this system depends on its application at the various marketing stages; whereas it is nevertheless desirable to exclude certain products and operations in particular those taking place at the start of the distribution network for agricultural products; Whereas the concept of a lot implies that several sales units of a foodstuff have almost identical production, manufacture or packaging characteristics; whereas that concept therefore could not apply to bulk products or products which, owing to their individual specificity or heterogeneous nature, could not be considered as forming a homogeneous batch; Whereas, in view of the variety of identification methods used, it is up to the trader to determine the lot and to affix the corresponding indication or mark; Whereas, in order to satisfy the information requirements for which it is intended, this indication must be clearly distinguishable and recognizable as such; Whereas the date of minimum durability or 'use by' date, may, in conformity with Directive 79/112/EEC, serve as the lot identification, provided it is indicated precisely, Article 1 1. This Directive concerns the indication which allows identification of the lot to which a foodstuff belongs. 2. For the purposes of this Directive, 'lot' means a batch of sales units of a foodstuff produced, manufactured or packaged under practically the same conditions. Article 2 1. A foodstuff may not be marketed unless it is accompanied by an indication as referred to in Article 1 (1). 2. However, paragraph 1 shall not apply: (a) to agricultural products which, on leaving the holding are: - sold or delivered to temporary storage, preparation or packaging stations, - transported to producers' organizations, or - collected for immediate integration into an operational preparation or processing system; (b) when, at the point of sale to the ultimate consumer, the foodstuffs are not prepackaged, are packaged at the request of the purchaser or are prepackaged for immediate sale; (c) to packagings or containers, the largest side of which has an area of less than 10 cm$. 3. Member States may, until 31 December 1996, refrain from requiring the indication referred to in Article 1 (1) to be mentioned in the case of the glass bottles intended for re-use which are indelibly marked and which therefore bear no label, ring or collar. Article 3 The lot shall be determined in each case by the producer, manufacturer or packager of the foodstuff in question, or the first seller established within the Community. The indication referred to in Article 1 (1) shall be determined and affixed under the responsibility of one or other of those operators. It shall be preceded by the letter 'L' except in cases where it is clearly distinguishable from the other indications on the label. Article 4 When the foodstuffs are prepackaged, the indication referred to in Article 1 (1) and, where appropriate, the letter 'L' shall appear on the prepackaging or on a label attached thereto. When the foodstuffs are not prepackaged, the indication referred to in Article 1 (1) and, where appropriate, the letter 'L' shall appear on the packaging or on the container or, failing that, on the relevant commercial documents. It shall in all cases appear in such a way as to be easily visible, clearly legible and indelible. Article 5 When the date of minimum durability or 'use by' date appears on the label, the indication referred to in Article 1 (1) need not appear on the foodstuff, provided that the date consists at least of the uncoded indication of the day and the month in that order. Article 6 This Directive shall apply without prejudice to the indications laid down by specific Community provisions. The Commission shall publish and keep up to date a list of the provisions in question. Article 7 Member States shall, where necessary, amend their laws, regulations or administrative provisions so as to: - authorize trade in products complying with this Directive by not later than 20 June 1990, - prohibit trade in products not complying with this Directive with effect from 20 June 1991, however, trade in products placed on the market or labelled before that date and not conforming with this Directive may continue until stocks run out. They shall forthwith inform the Commission thereof. Article 8 This Directive is addressed to the Member States.

31989L0437

1989

Council Directive 89/437/EEC of 20 June 1989 on hygiene and health problems affecting the production and the placing on the market of egg products 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, in order to ensure the smooth operation of the common market and more especially of the common organization of the market in eggs established by Regulation (EEC) No 2771/75 (4), as last amended by Regulation (EEC) No 3907/87 (5), and of the common system of trade for ovalbumin and lactalbumin introduced by Regulation (EEC) No 2783/75 (6), as amended by Regulation (EEC) No 4001/87 (7), it is essential that the marketing of egg products should no longer be hindered by disparities existing between Member States in respect of health requirements in this area; whereas this will enable production to be better harmonized and bring about competition on equal terms while assuring consumers of a quality product; (8) OJ No C 67, 14. 3. 1987, p. 9 and OJ No C 53, 2. 3. 1989, p. 10. (9) OJ No C 187, 18. 7. 1988, p. 184. (10) OJ No C 232, 31. 8. 1987, p. 1. (11) OJ No L 282, 1. 11. 1975, p. 49. (12) OJ No L 370, 30. 12. 1987, p. 14. (13) OJ No L 282, 1. 11. 1975, p. 104. (14) OJ No L 377, 31. 12. 1987, p. 44. Whereas the marketing of certain egg products which are not covered by Annex II to the Treaty is closely linked with the marketing of egg products for which a market organization exists; whereas distortions of competition should be eliminated for all egg products; Whereas it appears appropriate to exclude from the scope of this Directive egg products which are obtained in small scale enterprises, shops or restaurants and used for the manufacture of foodstuffs intended for direct sale to the final consumer or to be consumed on the spot; Whereas health requirements should be laid down for the production, storage and transport of egg products; whereas, in particular, it is important that rules be laid down governing the approval of establishments; Whereas it is important also that the health requirements to be met by egg products be laid down; Whereas the said rules must apply in an identical manner to intra-Community trade and to trade within the Member States; Whereas it is the responsibility primarily of producers to ensure that egg products meet the health requirements laid down in this Directive; whereas the competent authorities of the Member States must, by carrying out checks and inspections, see to it that producers comply with the abovementioned requirements; whereas the rules governing these checks and inspections must take account of the demands of the internal market; Whereas a random check must be made to detect the presence of residues of substances liable to be harmful to human health; Whereas Community control measures should be introduced to guarantee the uniform application in all Member States of the standards laid down in this Directive; Whereas, in the context of intra-Community trade, the consignor, the consignee or their representative must be given the opportunity, where a dispute arises with the competent authorities of the Member States of destination, of seeking an expert's opinion; Whereas egg products manufactured in a third country intended to be placed on the market on Community territory must not qualify for more favourable arrangements than those laid down in this Directive; whereas provision should be made for a Community procedure for inspecting establishments in third countries; 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 introducing close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee, Article 1 This Directive lays down hygiene and health requirements concerning the production and the placing on the market of egg products for direct human consumption or for the manufacture of foodstuffs. However, this Directive shall not apply to: - finished foodstuffs manufactured from egg products, as defined in Article 2 and which meet with the provisions of Article 3, - egg products which are obtained in small scale enterprises and which, without having undergone any treatment, are used for the manufacture of foodstuffs intended for direct sale, without any intermediary, to the consumer or consumed on the spot immediately after having been prepared. Article 2 For the purposes of this Directive, the definition given in Article 1 (2) of Regulation (EEC) No 2772/75 (15) shall apply. The following definitions shall also apply: 1. egg products: products obtained from eggs, their various components or mixtures thereof, after removal of the shell and membranes, intended for human consumption; they may be partially supplemented by other foodstuffs or additives; they may be liquid, concentrated, dried, crystallized, frozen, quick-frozen or coagulated; (16) OJ No L 282, 1. 11. 1975, p. 56. 2. farm of production: without prejudice to Regulation (EEC) No 2782/75 (17), farm for the production of eggs intended for human consumption; 3. establishment: establishment approved for the manufacture and/or treatment of egg products; 4. cracked eggs: eggs with a damaged but unbroken shell, with intact membranes; 5. batch: a quantity of egg products which have been prepared under the same conditions and in particular treated in a single continuous operation: 6. consignment: a quantity of egg products for a single delivery to one destination for further processing by the food industry or intended for direct human consumption; 7. country of dispatch: the Member State or third country from which egg products are dispatched to another Member State; 8. country of destination: the Member State to which egg products are dispatched from another Member State or from a third country; 9. packing: the placing of egg products in any form of package; 10. competent authority: the veterinary department or any other equivalent department designated by the Member State concerned to monitor compliance with the provisions of this Directive; 11. placing on the market: the marketing of egg products, as defined in point 5 of Article 1 of Regulation (EEC) No 2772/75. Article 3 Member States shall ensure that only egg products which meet the following general requirements are produced as foodstuffs or used in the manufacture of foodstuffs: (a) they must have been obtained from hens', ducks', geese's, turkeys's, guinea fowl's or quail's eggs, but not a mixture of eggs of different species; (b) they must bear an indication of the percentage of egg ingredients they contain when they are partially supplemented by other foodstuffs or, provided they fulfil the requirements of Article 12, by additives; (c) they must have been treated and prepared in an establishment approved in accordance with Article 6 which complies with Chapters I and II of the Annex, and satisfy the requirements of this Directive; (d) they must have been prepared under hygiene conditions complying with Chapters III and V of the Annex, from (18) OJ No L 282, 1. 11. 1975, p. 100. eggs meeting the requirements laid down in Chapter IV of the Annex; (e) they must have undergone a treatment process authorized under the procedure laid down in Article 14 which enables them to meet inter alia the analytical specifications laid down in Chapter VI of the Annex. However, where it is necessary for technological reasons associated with the preparation of certain foodstuffs obtained from egg products, the competent authority shall decide, on the basis of criteria to be determined in accordance with the procedure laid down in Article 14, that certain egg products need not undergo treatment; in such a case, the egg products must be used without delay in the establishment where they are intended for the manufacture of other foodstuffs; (f) they must comply with the analytical specifications set out in Chapter VI of the Annex; (g) they must have undergone a health check in accordance with Chapter VII of the Annex; (h) they must have been packed in accordance with Chapter VIII of the Annex; (i) they must be stored and transported in accordance with Chapters IX and X of the Annex; (j) they must bear the mark of wholesomeness provided for in Chapter XI of the Annex and, where intended for direct human consumption, must meet the requirements of 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 (19), as last amended by Directive 86/197/EEC (20). Article 4 The competent authorities shall ensure that the manufacturers of egg products adopt all measures necessary to comply with this Directive, and in particular that: - samples for laboratory examination are taken in order to check that the analytical specifications set out in Chapter VI of the Annex have been observed, - egg products that may not be kept at the ambient temperature are transported or stored at the temperatures stipulated in Chapters IX and X of the Annex, - the period during which the conservation of egg products is assured is laid down, - the results of the various checks and tests are recorded and kept for presentation to them for a period of two years, - each batch marked in such a way that its date of treatment can be identified; this batch mark must appear on the (21) OJ No L 33, 8. 2. 1979, p. 1. (22) OJ No L 144, 29. 5. 1986, p. 38. treatment record and on the mark of wholesomeness provided for in Chapter XI. Article 5 1. Member States shall ensure that checks are effected 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 egg products or make their consumption dangerous or harmful to human health. 2. If the egg products examined show traces of residues in excess of the permitted levels fixed in accordance with paragraph 4, they must not be allowed to be used in food for human consumption or placed on the market, either for the manufacture of foodstuffs or for direct human consumption. 3. Tests for residues must be carried out in accordance with proven and scientifically recognized methods, in particular those prescribed in Community Directives or other international standards. It must be possible to assess the tests for residues using reference methods laid down in accordance with the procedure set out in Article 14 after the Scientific Veterinary Committee has expressed its opinion. In accordance with the same procedure, at least one reference laboratory must be designated in each Member State to carry out the examination for residues in the event of application of Articles 7 and 8. The Commission shall publish the reference methods and the list of reference laboratories in the Official Journal of the European Communities. 4. Acting by a qualified majority on a proposal from the Commission, the Council shall adopt: - the detailed arrangements for monitoring, - the tolerances for the substances referred to in paragraph 2, - the frequency of sampling. Article 6 1. Member States shall draw up lists of their approved establishments, each of which shall have an approval number. Member States shall forward this list to the other Member States and to the Commission. No Member State shall approve an establishment unless compliance with this Directive is assured. A Member State shall withdraw approval if the conditions for granting it cease to be fulfilled. The other Member States and the Commission shall be informed of the withdrawal of approval. 2. The inspection and monitoring of establishments and packaging centres shall be carried out regularly on the responsibility of the competent authority, which shall at all times have free access to all parts of the establishments, in order to ensure that this Directive is being observed. If such inspections reveal that not all the requirements of this Directive are being met, the competent authority shall take the appropriate action to remedy the situation. Article 7 1. Experts from the Commission may, in cooperaton with the competent authorities, make on-the-spot checks insofar as that is indispensable for ensuring uniform application of the Directive; they may in particular verify whether establishments and packing centres approved in accordance with Article 5 (3) of Regulation (EEC) No 2772/75 are actually complying with the Directive. A Member State within the territory of which 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 State concerned of the results of the checks. The Member State concerned shall take any measures required to take account of the results of the check. If the Member State does not take those measures, the Commission may, in accordance with the procedure laid down in Article 13, decide that the Member State in question must suspend the placing on the market of egg products from the establishment which fails to comply with this Directive. 2. Before the checks referred to in paragraph 1 are carried out, in accordance with the procedure laid down in Article 14, the general provisions for applying this Article shall be determined and a Commission recommendation shall be established, containing the rules to be followed for the purpose of the checks provided for in paragraph 1. Article 8 1. Without prejudice to Articles 6 and 7, the country of destination may, where there are serious grounds for suspecting irregularities, carry out non-discriminatory inspections of egg products in order to check that a consignment meets the requirements of this Directive. 2. The inspections referred to in paragraph 1 shall be carried out at the place of destination of the goods or at another suitable place, provided that in the latter case the choice of the place interferes as little as possible with the routing of the goods. Such inspections must be carried out as soon as possible so as not unduly to delay the placing of egg products on the market, or cause delays which might impair their quality. 3. If, during an inspection carried out in accordance with paragraphs 1 and 2, it is found that the egg products do not comply with this Directive, the competent authority of the country of destination may give the consignor, the consignee or their representative the choice of withdrawing the consignment from the market in order that it may undergo further treatment or of using it for other purposes if this is permissible on health grounds. If not, the alternative offered must be the destruction of the egg products. In any event, precautionary measures shall be taken by the competent authority to prevent improper use of such egg products. 4. (a) Decisions and the grounds for taking them must be notified to the consignor, the consignee or their representative. Should such person so request, reasons must be given for such decisions and must be notified to him immediately in writing together with particulars of the remedies available to him under the law, their forms and the time limits within which action must be taken. Remedies available to the consignor, the consignee or their representative shall not be affected by this Directive. (b) If such decisions are based on the existence of a particularly serious risk to human health, they shall be communicated forthwith to the competent authority of the Member State of dispatch and to the Commission. (c) Following such communication, appropriate measures may be taken in accordance with the procedure laid down in Article 13, in particular for the purpose of coordinating the measures taken in other Member States with regard to the egg products concerned. 5. Member States shall grant consignors whose egg products may not be placed on the market as a result of an inspection as provided for in paragraph 1 the right to obtain an expert's opinion. The expert must be a national of a Member State other than the country of dispatch or the country of destination. The Commission, acting on a proposal from the Member States, shall draw up a list of experts who may be instructed to prepare such opinions. The detailed rules for the application of this paragraph shall be adopted according to the procedure laid down in Article 14. Article 9 Where a Member State considers, after carrying out an inspection in accordance with Article 8, that the provisions of this Directive are no longer being observed in an establishment in another Member State it shall so inform the competent authority of that State. The said authority shall take all necessary measures and notify the competent authority of the first Member State of the decisions taken and of the reasons for such decisions. If the first Member State fears that such measures have not been taken or are inadequate, the two Member States shall together seek ways and means of remedying the situation, if necessary by means of an inspection visit of the establishment. The Member States shall inform the Commission of disputes and of the solutions reached. If the Member States are unable to reach agreement, one of them shall refer the matter within a reasonable period to the Commission, which shall instruct one or more experts to deliver an opinion. Pending that opinion, the Member State of dispatch shall intensify checks on egg products coming from the establishment in question and, at the request of the Member State of destination, the Commission shall immediately instruct an expert to go to the consignor establishment in order to propose appropriate interim protective measures. In the light of the opinion provided for in the fourth subparagraph, or the result of the check performed in accordance with Article 7 (1), Member States may be authorized, under the procedure laid down in Article 13, temporarily to deny access to their territory for egg products coming from that establishment. Such authorization may be withdrawn under the procedure laid down in Article 13 on the basis of a further opinion delivered by one or more experts. The experts shall be nationals of a Member State other than those involved in the dispute. Detailed rules for the application of this Article shall be adopted in accordance with the procedure laid down in Article 14. Article 10 The Annex to this Directive shall be amended by the Council acting by a qualified majority on a proposal from the Commission. Article 11 1. Pending the application of the provisions of this Directive, national provisions governing imports of egg products from third countries shall continue to apply and must not be more favourable than those governing intra-Community trade. 2. On-the-spot inspections shall be carried out by experts from the Member States and the Commission. Member States' experts instructed to carry out these inspections shall be appointed by the Commission on proposals from the Member States. Inspections shall be carried out on behalf of the Community, which shall bear the costs relating thereto. 3. A list of the establishments which meet the requirements set out in the Annex shall be drawn up in accordance with the procedure laid down in Article 14. 4. The health certificate accompanying the products on importation and the form and nature of the mark of wholesomeness applied to the products shall correspond to a model to be determined in accordance with the procedure laid down in Article 14. Article 12 The Council, acting by a qualified majority on a proposal from the Commission, shall decide which additives contained in the list of additives authorized by the Community rules in force on additives which may be used in foodstuffs may be used for the egg products defined in Article 3 (a) and the detailed rules on such use. Pending such decision, national rules governing such use shall continue to apply. Article 13 1. Where the procedure laid down in this Article is to be applied, the matter shall be referred forthwith to the Standing Veterinary Committee set up by the Council Decision of 15 October 1968 (hereinafter referred to as ´the committee') by its chairman on his initiative or at the request of a Member State. 2. The respresentative 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. 4. 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 15 days of 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 14 1. Where the procedure laid down in this Article is to be applied, the chairman shall refer the matter without delay to the committee 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 State 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. 4. 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 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 15 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1991. They shall inform the Commission thereof forthwith. The Commission shall, no later than 31 December 1994, submit a report to the Council on the experience acquired on the subject, accompanied, where appropriate, by proposals aimed at adapting the Annex to this Directive taking special account of scientific and technological developments. Article 16 This Directive is addressed to the Member States.

31989L0439

1989

Council Directive 89/439/EEC of 26 June 1989 amending Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant products 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 by Directive 77/93/EEC (3), as last amended by Directive 89/359/EEC (4), the Council laid down protective measures against the introduction into the Member States of organisms harmful to plants or plant products; whereas the protection of plants against such organisms is absolutely necessary to increase agricultural productivity, which is one of the objectives of the common agricultural policy; Whereas the plant health laws applicable to the French overseas departments have not been harmonized in accordance with Directive 77/93/EEC; whereas, given the importance of their trade in plant and plant products with the remainder of the Community, it is now desirable to apply the provisions of that Directive to them; whereas in view of the special nature of the agricultural production of the French overseas departments it is appropriate to provide for additional protective measures justified on grounds of the protection of health and life of plants therein; whereas the provisions of Directive 77/93/EEC should also be extended to protective measures against the introduction of harmful organisms into the French overseas departments from other parts of France; Whereas it has become necessary to clarify the requirement in Article 9 (1) of Directive 77/93/EEC that the official phytosanitary certificate required under Article 7 of the Directive must be issued in the country of origin of the plants, plant products or other objects concerned; whereas it appears appropriate to define the exceptions to this requirement in a more general manner so that Article 9 (1) need to be amended whenever a relevant amendment is made by the Commission to Annex IV; Whereas it is appropriate to provide in certain cases that the official inspection of plants, plant products and other objects coming from third countries, provided for in Article 12 (1) of the said Directive, should be carried out by the Commission in the third country of origin; (5) OJ No C 117, 4. 5. 1988, p. 11. (6) OJ No C 187, 18. 7. 1988, p. 213. (7) OJ No L 26, 31. 1. 1977, p. 20. (8) OJ No L 153, 6. 6. 1989, p. 28. Whereas it has become necessary to improve the functioning of the safeguard clause provided for in Article 15 of that Directive with a view to allowing more rapid, more comprehensive and more effective Community action in cases where that clause is used; whereas the Commission should have broader powers in connection with the adoption of safeguard measures by Member States; Whereas the measures taken with a view to the progressive reduction of checks by Member States of destination will necessitate a strengthening of the checks carried out by consignor Member States; whereas it therefore appears necessary to reinforce Community plant health régime, with a view to improving the productivity of agriculture and achieving the single market by the end of 1992, but in particular with a view to increasing confidence in all plant health checks carried out on plant products intended for marketing within the Community; Whereas these reinforced Community inspections must be made by experts employed by the Commission, and also by experts employed by Member States, whose services are made available to the Commission; Whereas the role of these experts should be defined in connection with the activities required under the Community plant health régime, Article 1 Directive 77/93/EEC is hereby amended as follows: 1. Article 1 is amended as follows: (a) in paragraph 2, ´to the French overseas departments, nor' is deleted; (b) the following paragraphs are added: ´3. This Directive shall also concern protective measures against the introduction of harmful organisms into the French overseas departments from other parts of France and, conversely, into other parts of France from the French overseas departments. 4. Without prejudice to the conditions to be established for the protection of the plant health situation existing in certain regions in the Community, taking into account the differences in agricultural and ecological conditions, protective measures which are justified on grounds of the protection of health and life of plants in the French overseas departments and which are additional to those laid down in this Directive may be determined in accordance with the procedure laid down in Article 16a.' 2. Article 9 (1) is replaced by the following: ´1. In the case of plants, plant products or other objects to which special requirements laid down in Annex IV, Part A apply, the official phytosanitary certificate required pursuant to Article 7 shall have been issued in the country in which the plant, plant products and other objects originate, save: - in the case of wood, if under the special requirements laid down in Annex IV, Part A, it is sufficient that it is stripped of its bark, - in other cases, to the extent that the special requirements laid down in Annex IV Part A can be fulfilled also at places other than that of origin.' 3. In Article 11 (1), first sentence, ´at the time of their introduction' is replaced by ´in the event of their introduction'. 4. In Article 11 (1), second sentence, the text under (b) is deleted. 5. Article 11 (4) is replaced by the following: ´4. If it is ascertained that part of a consignment of plants, plant products or other objects is contaminated by harmful organisms listed in Annexes I and II, the introduction of the other part shall not be prohibited provided that it is not suspected of being contaminated and provided that there appears to be no possibility of harmful organisms spreading.' 6. The following paragraph shall be added to Article 12: ´5. It may be agreed, in technical arrangements made between the Commission and the competent bodies in certain third countries and approved in accordance with the procedure laid down in Article 16a that activities related to the inspections referred to in paragraph 1 (a) may also be carried out under the authority of the Commission and in accordance with the relevant provisions of Article 19a in the third country concerned, in cooperation with the official plant protection organization of that country.' 7. In Article 14 (2), second sentence, the following is inserted after ´after adoption of the said provisions': ´and, where appropriate, following investigations carried out under the authority of the Commission and in accordance with the relevant provisions of Article 19a in the country of origin of the plants or plant products concerned.' 8. In Article 14 (3), the following subparagraph is added: ´The risk shall be assessed on the basis of available scientific and technical information; where such information is insufficient, it shall be supplemented by additional enquiries or, where appropriate, by investigations carried out under the authority of the Commission and in accordance with the relevant provisions of Article 19a in the country of origin of the plants, plant products or other objects concerned.' 9. Article 15 (2) is replaced by the following: ´2. In cases referred to in paragraph 1 the Commission shall examine the situation as soon as possible within the Standing Committee on Plant Health. On-site investigations may be made under the authority of the Commission and in accordance with the relevant provisions of Article 19a. The necessary measures may be adopted, including those whereby it may be decided whether measures taken by the Member States should be rescinded or amended, under the procedure laid down in Article 17. The Commission shall follow the development of the situation and, under the same procedure, shall amend or repeal, as that development requires, the said measures. Until a measure has been adopted under the aforesaid procedure, the Member State may maintain the measures that it has employed.' 10. The following Article is inserted: ´Article 16a 1. Where the procedure laid down in this Article is to be followed, the matter shall be referred without delay to the Standing Committee on Plant Health (hereinafter referred to as "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 representative of the Commission shall submit a draft of the measures to be taken. The committee shall deliver its opinion on these measures within a time limit set by the chairman having regard to the urgency of the matters to be examined. Opinions shall be delivered by a majority of 54 votes. 4. Where the measures are in accordance with the opinion of the committee, the Commission shall adopt them and shall implement them forthwith. Where the measures are not in accordance with the opinion of the committee or if no opinion is delivered, the Commission shall immediately submit to the Council a proposal on the measures to be taken. The Council shall adopt the measures by a qualified majority. If, within three months following the date on which the matter was referred to it, the Council has not adopted measures, the Commission shall adopt the proposed measures.' 11. The following Article is inserted: ´Article 19a 1. For the purpose of ensuring the correct and uniform application of this Directive, and without prejudice to checks carried out under the authority of the Member States, the Commission may organize checks to be carried out by experts under its authority in respect of the tasks listed in paragraph 3, on- or off-site, in accordance with the provisions of this Article. Where such checks are carried out in a Member State, this must be done in cooperation with the official plant protection organization of that Member State as specified in paragraphs 4 and 5 and in accordance with the procedures set out in paragraph 7. 2. The experts referred to in paragraph 1 may be: - employed by the Commission, - employed by Member States, and put at the disposal of the Commission on a temporary or ad hoc basis. They shall have acquired, at least in one Member State, the qualifications required for persons in charge of carrying out and monitoring official plant health inspections. 3. The checks referred to in paragraph 1 may be carried out in respect of the following tasks: - monitoring examinations pursuant to Article 6, - monitoring or, within the framework of the provisions laid down in Article 5 (c), carrying out inspections pursuant to Article 12 (1), - carrying out the activities specified in the technical arrangements referred to in Article 12 (5), - making the investigations referred to in Articles 14 (2) and (3) and 15 (2), - assisting the Commission in the matters referred to in paragraph 6, - carrying out any other duty assigned to the experts by the Council, acting by a qualified majority on a proposal from the Commission. 4. For the purpose of the tasks listed in paragraph 3, the experts referred to in paragraph 1 may: - visit nurseries, farms and other places where plants, plant products or other objects are or were grown, produced, processed or stored, - visit places where examinations pursuant to Article 6 or inspections pursuant to Article 12 are carried out, - consult officials of the official plant protection organizations of the Member States, - accompany the Member States' national inspectors when they carry out activities for the purposes of applying this Directive. 5. (a) Under the cooperation mentioned in paragraph 1, second sentence, the official plant protection organization of that Member State shall be given sufficient advance notice of the task to permit the necessary arrangements to be made. Member States shall take all reasonable steps to ensure that the objectives and effectiveness of inspections are not jeopardized. They shall ensure that the experts may carry out their tasks without hindrance, and shall take all reasonable steps to provide them, on their request, with the available necessary facilities, including laboratory equipment and laboratory staff. The Commission shall ensure refunding of expenses resulting from such requests, within the limits of appropriations available for that purpose in the Community budget. The experts shall, wherever national legislation so requires, be duly mandated by the official plant protection organization of the Member State concerned and observe the rules and practices imposed on that Member State's officials. (b) Where the task consists of monitoring examinations (paragraph 3, first indent), monitoring inspections (paragraph 3, second indent, first possibility) or of making investigations (paragraph 3, fourth indent), no decision may be taken on-site. The experts shall report to the Commission on their activities and their findings. (c) Where the task consists of carrying out inspections pursuant to Article 12 (1) (paragraph 3, second indent, second possibility), those inspections shall be integrated in an established inspection programme and the rules of procedure established by the Member State concerned shall be complied with; however, in the case of a joint inspection, the Member State concerned will only allow the introduction of a consignment into the Community if its plant protection organization and the Commission are in agreement. In accordance with the procedure laid down in Article 16a, this condition may be extended to other irrevocable requirements applied to consignments before introduction into the Community if experience shows such extension to be necessary. Should the Community expert and the national inspector fail to agree, the Member State concerned shall take any necessary temporary measures, pending a definitive decision. (d) In all cases national provisions in respect of criminal proceedings and administrative penalties shall apply according to the normal procedures. Where the experts identify a suspected infringement of the provisions of this Directive, this shall be notified to the competent authorities of the Member State concerned. 6. The Commission shall: - establish a network for the notification of new occurrences of harmful organisms, - make recommendations for drawing up guidelines for the experts and for national inspectors in carrying out their activities. To assist the Commission in this latter task, Member States shall notify the Commission of the current national inspection procedures in the plant health field. 7. The Commission shall adopt, under the procedure laid down in Article 16a, detailed rules for the application of this Article, including those applicable to the cooperation mentioned in paragraph 1, second subparagraph. 8. The Commission shall report to the Council, before 31 December 1994, on the experience gained from the implementation of the provisions of this Article. The Council, acting by a qualified majority on a proposal from the Commission, shall take the necessary measures to amend these provisions, if appropriate, in the light of this experience.' Article 2 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 1 January 1990. 2. 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.

31989L0424

1989

Commission Directive 89/424/EEC of 30 June 1989 amending Directive 86/109/EEC limiting the marketing of seed of certain species of fodder plants and oil and fibre plants to seed which has been officially certified as 'basic seed' or 'certified seed' Having regard to the Treaty establishing the European Economic Community, Having regard to Directive 66/401/EEC of the Council of 14 June 1966 on the marketing of fodder plant seed (1), as last amended by Directive 89/100/EEC (2), and in particular Article 3 (3) thereof, Having regard to Directive 69/208/EEC of the Council of 30 June 1969 on the marketing of seed of oil and fibre plants (3), as last amended by Directive 88/380/EEC (4), and in particular Article 3 (3) thereof, Whereas Directive 66/401/EEC allows the marketing of basic seed, certified seed and commercial seed of certain species of fodder plants; Whereas Directive 69/208/EEC allows the marketing of basic seed, certified seed and commercial seed of certain species of oil and fibre plants; Whereas Article 3 (3) of each of the aforementioned Directives authorizes the Commission to prohibit the marketing of seed unless it has been officially certified as 'basic seed' or 'certified seed'; Whereas, accordingly, Commission Directive 86/109/EEC (5) limits the marketing of seed of particular species of fodder plants and oil and fibre plants to seed which has been officially certified as 'basic seed' or 'certified seed'; Whereas for some of the species referred to in Directive 86/109/EEC this marketing restriction applies as from 1 July 1989; whereas it now appears that, for a number of these species, Member States will not be in a position, at that date, to produce sufficient basic seed and certified seed to satisfy the demand for seed within the Community; Whereas it is therefore appropriate to postpone the application of this marketing restriction until 1 July 1990 for brown top, birdsfoot trefoil, black medick and alsike clover and until 1 July 1991 for the other species concerned; Whereas it has also been established, on the basis of the information available at present, that, as from 1 July 1991, Member States will be in a position to produce sufficient basic seed and certified seed to satisfy within the Community the demand for seed of rescue grass, Alaska brome-grass, Egyptian clover and California bluebell; 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 Directive 86/109/EEC is hereby amended as follows: 1. Article 2 is replaced by the following: 'Article 2 Member States shall provide that from 1 July 1989 it shall not be permitted to place on the market seed of: 1.2 // - Agrostis gigantea Roth // - redtop // - Agrostis stolonifera L. // - creeping bent grass // - Phleum bertolonii DC // - timothy // - Poa palustris L. // - swamp meadowgrass // - Poa trivialis L. // - rough-stalked meadowgrass // - Lupinus albus L. // - white lupin, varieties other than bitter // - Brassica juncea (L.) Czernj. et Cosson // - brown mustard unless it has been officially certified as "basic seed" or "certified seed".' 2. The following Article is inserted: 'Article 2a Member States shall provide that from 1 July 1990 it shall not be permitted to place on the market seed of: 1.2 // - Agrostis capillaris L. // - brown top // - Lotus corniculatus L. // - birdsfoot trefoil // - Medicago lupulina L. // - black medick // - Trifolium hybridum L. // - alsike clover unless it has been officially certified as "basic seed" or "certified seed".' 3. Article 3 is replaced by the following: 'Article 3 Member States shall provide that from 1 July 1991 it shall not be permitted to place on the market seed of: 1.2 // - Agrostis canina L. // - velvet bent // - Alopecurus pratensis L. // - meadow foxtail // - Arrhenatherum elatius (L.) Beauv. ex J. S. et K. B. Presl // - tall oatgrass // - Bromus catharticus Vahl // - rescue grass // - Bromus sitchensis Trin. // - Alaska brome-grass // - Festuca ovina L. // - sheep's fescue // - Poa nemoralis L. // - wood meadowgrass // - Trisetum flavescens (L.) Beauv. // - golden oatgrass // - Lupinus albus L. // - white lupin, bitter varieties // - Lupinus angustifolius L. // - blue lupin // - Lupinus luteus L. // - yellow lupin // - Trifolium alexandrium L. // - Egyptian clover // - Trifolium incarnatum L. // - crimson clover // - Trifolium resupinatum L. // - Persian clover // - Vicia sativa L. // - common vetch // - Vicia villosa Roth // - hairy vetch // - Phacelia tanacetifolia Benth. // - California bluebell // - Sinapis alba L. // - white mustard unless it has been officially certified as "basic seed" or "certified seed".' 4. In Article 4, after the second indent, the following indent is inserted: '- not later than 1 July 1990 the laws, regulations or administrative provisions necessary to comply with Article 2a, and'. Article 2 This Directive is addressed to the Member States.

31989L0491

1989

Commission Directive 89/491/EEC of 17 July 1989 adapting to technical progress Council Directives 70/157/EEC, 70/220/EEC, 72/245/EEC, 72/306/EEC, 80/1268/EEC and 80/1269/EEC relating to motor vehicles Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 70/157/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the permissible sound level and the exhaust system of motor vehicles (1), as last amended by Directive 87/354/EEC (2), and in particular Article 3 thereof, Having regard to Council Directive 70/220/EEC of 20 March 1970 on the approximation of the laws of the Member States relating to measures to be taken against air pollution by emissions from motor vehicles (3), as last amended by Directive 88/436/EEC (4), and in particular Article 5 thereof, Having regard to Council Directive 72/245/EEC of 20 June 1972 on the approximation of the laws of the Member States relating to the suppression of radio interference produced by spark-ignition engines fitted to motor vehicles (5), and in particular Article 4 thereof, Having regard to Council Directive 72/306/EEC of 2 August 1972 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of pollutants from diesel engines for use in vehicles (6), and in particular Article 4 thereof, Having regard to Council Directive 80/1268/EEC of 16 December 1980 on the approximation of the laws of the Member States relating to the fuel consumption of motor vehicles (7), and in particular Article 3 thereof, Having regard to Council Directive 80/1269/EEC of 16 December 1980 on the approximation of the laws of the Member States relating to the engine power of motor vehicles (8), as last amended by Directive 88/195/EEC (9), and in particular Article 3 thereof, Whereas Council Directive 88/76/EEC (10) amending Directive 70/220/EEC introduces requirements relating to the use of unleaded petrol; whereas the adaptation of existing engines to this petrol necessitates in many cases technical modifications which are relevant to the compliance with the abovementioned Directives; whereas it appears appropriate to facilitate the administrative handling of the resulting amendments of the type-approval of the vehicles concerned in the interests of rapidly increasing use of unleaded petrol; whereas it appears also necessary to render more precise the specifications of Directive 88/76/EEC preventing vehicles equipped with emission control devices which would be adversely affected by leaded petrol, to be refuelled with such petrol; whereas it appears equally appropriate to introduce the new reference fuel for diesel engines specified in this Directive into Directive 72/306/EEC relating to the smoke emissions of such engines; whereas it appears advisable to align on this occasion the technical provisions of Directive 80/1269/EEC relating to engine power to those of the corresponding Regulation of the Economic Commission for Europe; Whereas it is desirable to introduce the amendments contained in the present Directive as soon as possible into the national laws concerned as they are particularly needed during the transitional period where vehicles conceived for the use of leaded petrol and vehicles requiring unleaded petrol will co-exist; 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 Motor Vehicles, Article 1 The undermentioned Directives are hereby amended in accordance with the Annexes to this Directive: - Directive 70/157/EEC is amended in accordance with Annex I, - Directive 70/220/EEC is amended in accordance with Annex II, - Directive 72/245/EEC is amended in accordance with Annex III, - Directive 72/306/EEC is amended in accordance with Annex IV, - Directive 80/1268/EEC is amended in accordance with Annex V, - Directive 80/1269/EEC is amended in accordance with Annex VI. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1990. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31989L0451

1989

Commission Directive 89/451/EEC of 17 July 1989 adapting to technical progress for the third time Council Directive 77/728/EEC on the approximation of the laws, Regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of paints, varnishes, printing inks, adhesives and similar products Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 77/728/EEC of 7 November 1977 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of paints, varnishes, printing inks, adhesives and similar products (1), as last amended by Directive 88/379/EEC (2), and in particular Article 11 thereof, Whereas Annex II to Directive 77/728/EEC lays down special provisions concerning the labelling of certain preparations, particularly paints and varnishes containing lead; whereas Article 2 of Directive 86/508/EEC (3) provides for a revision of the limit value for lead by 31 December 1988 at the latest and whereas, under these circumstances, the numerical value laid down in point 1 of Annex II should be revised; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of Directives relating to the removal of technical barriers to trade in dangerous substances and preparations, Article 1 Directive 77/728/EEC is hereby amended as follows: The numerical value 0,25 % in point 1 of Annex II shall be replaced by 0,15 %, the rest of the text remaining unchanged. Article 2 Member States shall adopt and publish the provisions necessary to comply with the Directive before 15 April 1990. They shall forthwith inform the Commission thereof. They shall apply those provisions from 15 October 1990 at the latest. The provisions adopted pursuant to the first subparagraph shall make express reference to this Directive. Article 3 This Directive is addressed to the Member States.

31989L0440

1989

Council Directive 89/440/EEC of 18 July 1989 amending Directive 71/305/EEC concerning coordination of procedures for the award of public works contracts 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, In cooperation with the European Parliament (1), Having regard to the opinion of the Economic and Social Committee (2), 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; Having regard to the conclusions drawn by successive meetings of the European Council on the need to establish such a market, Having regard to the White Paper on completing the internal market and in particular to the timetable and programme laid down therein for the opening up of the market for public works contracts, Having regard to the Commission's communication to the Council of 19 June 1986 on public procurement in the Community, Whereas public works contracts are governed by Council Directive 71/305/EEC of 26 July 1971 concerning the coordination of procedures for the award of public works contracts (3), as last amended by the Act of Accession of Spain and Portugal, and Council Directive 72/277/EEC of 26 July 1972 concerning the details of publication of notices of public works contracts and concessions in the Official Journal of the European Communities (4), by the declaration of 26 July 1971 of the representatives of the Governments of the Member States, meeting within the Council, concerning procedures to be followed in the field of public works contracts (5), and by Council Decision 71/306/EEC of 26 July 1971 setting up an Advisory Committee for Public Contracts (6), as amended by Decision 77/63/EEC (7); Whereas, in order to guarantee real freedom of establishment and freedom to provide services in the market for public works contracts, it is necessary to improve and extend the safeguards in the directives that are designed to introduce transparency into the procedures and practices for the award of such contracts, in order to be able to monitor compliance with the prohibition of restrictions more closely and at the same time to reduce disparities in the competitive conditions faced by nationals of different Member States; Whereas this Directive does not prevent the application of, in particular, Article 36 of the Treaty; Whereas it is to define more precisely what is meant by public works contracts in order to take account, in particular, of new forms of such contracts, and to lay down criteria for identifying all the entities which are subject to Directive 71/305/EEC; Whereas the list of bodies and categories of bodies in Annex I should be as exhaustive as possible; Whereas it is also necessary to extend the provisions of Directive 71/305/EEC to works that are subsidized by the State but do not come within the terms of Article 1; Whereas, in view of the increasing importance of concession contracts in the public works area and of their specific nature, the rules concerning advertising should be brought within Directive 71/305/EEC; Whereas it is necessary to clarify the scope of the exemptions for certain sectors in order that divergences in the application of Directive 71/305/EEC due to divergent interpretations of the exemptions in different Member States do not increase; Whereas the threshold value from which contracts are subject to Directive 71/305/EEC was set in 1971 at ECU 1 million and whereas, in view of the rise in the cost of construction work and the interest of small and medium-sized firms in bidding for medium-sized contracts, this threshold should now be set at ECU 5 million; 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 contractors to procedures for the award of contracts; Whereas it is desirable to introduce provision for a negotiated procedure such as already exists in the practice of some Member States, in order to curtail the use of the exceptional procedure provided for in Article 9 of Directive 71/305/EEC; Whereas the negotiated procedure should be considered to be exceptional and therefore only applicable in certain limited cases; Whereas contracting authorities should be required to inform rejected candidates and tenderers of the reasons for rejection in their application or bid and to draw up a report on the conduct of the proceedings leading up to each award; Whereas it is necessary to adapt the common rules in the technical field to the new Community policy on standards; Whereas, to create the necessary conditions for efficient Community-wide competition for contracts so that firms from other Member States can bid on comparable terms to domestic firms and a greater level of interest and participation in contracts is aroused from a larger number of contractors, all the operations and procedures involved in the competitive tendering for contracts should be made more transparent; whereas contracting authorities should also be required, to announce forthcoming public works projects throughout the Community, and to publish, in the same way, all relevant details of how contracts have been awarded; Whereas, in order to improve access to contracts and allow a larger number of contractors to complete and to prepare their bids in reasonable time, especially for large projects which are generally of considerable technical and organizational complexity, the time limits for the receipt of applications to bid and tenders should be lengthened; Whereas it is in the general interest to encourage technical advances in the construction and public works sector so that transfer of technology and know-how from one Member State to another benefits not only the general public but also the construction industry; Whereas work is under way in the Community on methods of framing specifications in terms of performance requirements instead of as detailed technical prescriptions and contractors in the Community should immediately be given the opportunity to submit variants under certain conditions; Whereas, to ensure transparency as to how contractors propose to carry out a contract, it must be made possible for contracting authorities to be informed of any part of the contract the tenderer intends to subcontract to third parties; 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; Whereas it is appropriate that national provisions for regional development requirements to be taken into consideration in the award of public works contracts should be made to conform to the objectives of the Community and be in keeping with the principles of the Treaty; Whereas adequate statistical provision should be included in Directive 71/305/EEC in order to improve, and to put on a more systematic basis, information on the way in which contracting authorities award their contracts; Whereas the Kingdom of Spain has recently adopted legislation to implement Directive 71/305/EEC; whereas, given the fact that the introduction of other amendments at this stage would adversely effect the adaptation of the private sector in that Member State, it is appropriate to grant the Kingdom of Spain an additional period to implement this Directive; Whereas the Portuguese Republic is in need of a transitional period for similar reasons; Whereas the Hellenic Republic will be adapting its legislation to Directive 71/305/EEC and whereas incorporation, at this stage, of other Community rules would have an adverse effect upon the public works contracts sector and in particular upon certain economically important factors such as the stability, transparency and maintenance, in the medium term, of commercial conditions; Whereas in accordance with the conclusions of the said meetings of the European Council, of the White Paper and of the said Commission communication to the Council, Directive 77/305/EEC should be amended and Directive 72/277/EEC repealed, Article 1 Directive 71/305/EEC is hereby amended as follows: 1. Article 1 is replaced by the following: ´Article 1 For the purpose of this Directive: (a) "public works contracts'' are contracts for pecuniary interest concluded in writing between a contractor and a contracting authority as defined in (b), which have as their object either the execution, or both the execution and design, of works related to one of the activities referred to in Annex II or a work defined in (c) below, or the execution by whatever means of a work corresponding to the requirements specified by the contracting authority; (b) "contracting authorities'' shall be the State, regional or local authorities, bodies governed by public law, associations formed by one or several of such authorities or bodies governed by public law. A 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 are set out in Annex I. These lists shall be as exhaustive as possible and may be reviewed in accordance with the procedure laid down in Article 30b. To this end, Member States shall periodically notify the Commission of any changes to their lists of bodies and categories of bodies; (c) a "work'' means the outcome of building or civil engineering works taken as a whole that is sufficient of itself to fulfil an economic and technical function; (d) "public works concession'' is a contract of the same type as that indicated in (a) except for the fact that the consideration for the works to be carried out consists either solely in the right to exploit the construction or in this right together with payment; (e) "open procedures'' are those national procedures whereby all interested contractors may submit tenders; (f) "restricted procedures'' are those national procedures whereby only those contractors invited by the contracting authority may submit tenders; (g) "negotiated procedures'' are those national procedures whereby contracting authorities consult contractors of their choice and negotiate the terms of the contract with one or more of them; (h) a contractor who submits a tender shall be designated by the term "tenderer'' and one who has sought an invitation to take part in a restricted and negotiated procedure by the term "candidate''.' 2. The following Articles are inserted: ´Article 1a 1. 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 works contract awarded by an entity other than themselves. 2. Paragraph 1 shall concern only contracts covered by Class 50, Group 502, of the NACE nomenclature and to contracts relating to building work for hospitals, facilities intended for sports, recreation and leisure, school and university buildings and buildings used for administrative purposes. Article 1b 1. Should contracting authorities conclude a public works concession contract as defined in Article 1 (d), the advertising rules as described in Article 12 (3), (6), (7) and (9) to (13), and in Article 15a, shall apply to that contract when its value is not less than ECU 5 000 000. 2. The contracting authority may: - either require the concessionaire to award contracts representing a minimum of 30 % of the total value of the work for which the concession contract is to be awarded, to third parties, at the same time providing the option for candidates to increase this percentage. This minimum percentage shall be specified in the concession contract, - or request the candidates for concession contracts to specify in their tenders the percentage, if any, of the total value of the work for which the concession contract is to be awarded which they intend to assign to third parties. 3. When the concessionaire is himself one of the authorities awarding contracts within the meaning of Article 1 (b), he shall comply with the provisions of this Directive in the case of works to be carried out by third parties. 4. Member States shall take the necessary steps to ensure that a concessionaire other than an authority awarding contracts shall apply the advertising rules listed in Article 12 (4), (6), (7), and (9) to (13), and in Article 15b, in respect of the contracts which it awards to third parties when the value of the contracts is not less than ECU 5 000 000. Advertising rules shall not be applied where works contracts meet the conditions laid down in Article 5 (3). Undertakings which have formed a group in order to obtain the concession contract, or undertakings affiliated to them, shall not be regarded as third parties. An "affiliated undertaking'' means any undertaking over which the concessionaire may exercise, directly or indirectly, a dominant influence or which may exercise a dominant influence over the concessionaire or which, in common with the concessionaire, is subject to the dominant influence of another undertaking by virtue of ownership, financial participation or the rules which govern it. A dominant influence on the part of an undertaking shall be presumed when, directly or indirectly in relation to another undertaking, it: - holds the major part of the undertaking's subscribed capital, or - controls the majority of the votes attaching to shares issued by the undertakings, or - can appoint more than half of the members of the undertaking's administrative, managerial or supervisory body. A comprehensive list of these undertakings shall be enclosed with the candidature for the concession. This list shall be brought up to date following any subsequent changes in the relationship between the undertaking.' 3. Article 2 is hereby repealed. 4. Article 3 (1), (2) and (3) is hereby repealed and paragraphs 4 and 5 thereof are replaced by the following: ´4. This Directive shall not apply to: (a) works contracts awarded by carriers by land, air, sea or inland waterway; (b) works contracts awarded by contracting authorities, in so far as those contracts concern the production, transport and distribution of drinking water, or those contracting authorities whose principal activity lies in the production and distribution of energy; (c) works contracts 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.' 5. Article 4 is replaced by the following: ´Article 4 This Directive shall not apply to public contracts governed by different procedural rules and awarded: (a) in pursuance of an international agreement, concluded in conformity with the EEC Treaty, between a Member State and one or more non-member countries and covering works intended for the joint implementation or exploitation of a project by the signatory States; all agreements shall be communicated to the Commission which may consult the Advisory Committee for Public Contracts set up by Decision 71/306/EEC (8), as amended by Decision 77/63/EEC (9); (b) to undertakings in a Member State or a non-member country in pursuance of an international agreement relating to the stationing of troops; (c) pursuant to the particular procedure of an international organization. (10) OJ No L 185, 16. 8. 1971, p. 15. (11) OJ No L 13, 15. 1. 1977, p. 15.' 6. The following Article is inserted: ´Article 4a 1. The provisions of this Directive shall apply to public works contracts whose estimated value net of VAT is not less than ECU 5 000 000. 2. The value of the threshold in national currencies shall normally be revised every two years with effect from 1 January 1993. The calculation of this value shall be based on the average daily values of these currencies in terms of the ecu over the 24 months terminating on the last day of October immediately preceding the 1 January revision. The values shall be published in the Official Journal of the European Communities at the beginning of November. 3. Where a work is 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 amounts referred to in paragraph 1. Where the aggregate value of the lots is not less than the amount referred to in paragraph 1, the provisions of that paragraph shall apply to all lots. Contracting authorities shall be permitted to depart from this provision for lots whose estimated value net of VAT is less than ECU 1 000 000, provided that the total estimated value of all the lots exempted does not, in consequence, exceed 20 % of the total estimated value of all lots. 4. No work or contract may be split up with the intention of avoiding the application of the preceding paragraphs. 5. When calculating the amounts referred to in paragraph 1 and in Article 5, account shall be taken not only of the amount of the public works contracts but also of the estimated value of the supplies needed to carry out the works which are made available to the contractor by the contracting authorities.' 7. Article 5 is replaced by the following: ´Article 5 1. In awarding public works contracts the contracting authorities shall apply the procedures defined in Article 1 (e), (f) and (g), adapted to this Directive. 2. The contracting authorities may award their public works contracts by negotiated procedure, with prior publication of a tender notice and after having selected the candidates according to qualitative public criteria, 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 the provisions of Title IV, in so far as the original terms of the contract are not substantially altered. The contracting authorities shall not, in these cases, publish a tender notice where they include in such negotiated procedure all the enterprises satisfying the criteria of Articles 23 to 28 which, during the prior open or restricted procedure, have submitted offers in accordance with the formal requirements of the tendering procedure; (b) when the works involved are carried out purely for the purpose of research, experiment or development, and not to establish commercial viability or to recover research and development costs; (c) in exceptional cases, when the nature of the works or the risks attaching thereto do not permit prior overall pricing. 3. The contracting authorities may award their public works contracts by negotiated procedure without prior publication of a tender notice, in the following cases: (a) in the absence of tenders or of appropriate tenders in response to an open or restricted procedure in so far as the original terms of the contract are not substantially altered and provided 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 works may only be carried out by a particular contractor; (c) in so far as is strictly necessary when, for reasons of extreme urgency brought about by events unforeseen by the contracting authorities in question, the time limit laid down for the open, restricted or negotiated procedures referred to in paragraph 2 above cannot be kept. The circumstances invoked to justify extreme urgency must not in any event be attributable for the contracting authorities; (d) for additional works not included in the project initially considered or in the contract first concluded but which have, through unforeseen circumstances, become necessary for the carrying out of the work described therein, on condition that the award is made to the contractor carrying out such work: - when such works cannot be technically or economically separated from the main contract without great inconvenience to the contracting authorities, or - when such works, although separable from the execution of the original contract, are strictly necessary to its later stages, however, the aggregate value of contracts awarded for additional works may not exceed 50 % of the amount of the main contract; (e) for new works consisting of the repetition of similar works entrusted to the undertaking to which the same contracting authorities awarded an earlier contract, provided that such works 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 this procedure might be adopted and the total estimated cost of subsequent works shall be taken into consideration by the contracting authorities when they apply the provisions of Article 4a. This procedure may only be applied during the three years following the conclusion of the original contract. 4. In all other cases, the contracting authorities shall award their public works contracts by the open procedure or by the restricted procedure.' 8. The following Article is inserted: ´Article 5a 1. The contracting authority shall, within 15 days of the date on which the request is received, inform any eliminated candidate or tenderer who so requests of the reasons for rejection of his application or his tender, and, in the case of a tender, the name of the sucessful tenderer. 2. The contracting authority shall inform candidates or tenderers who so request 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 for his tender having been selected and, if known, any share of the contract the successful tenderer may intend to subcontract to a third party, - for negotiated procedures, the circumstances referred to in Article 5 which justify the use of these procedures. This report, or the main features of it, shall be communicated to the Community at its request.' 9. Article 7, 8 and 9 are hereby repealed. 10. Article 10 is replaced by the following: ´Article 10 1. The technical specifications defined in Annex III shall be given in the general or contractual documents relating to each contract. 2. Without prejudice to the legally binding national technical rules and in so far 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 provision for establishing conformity, or technical means do not exist for establishing satisfactorily the conformity of a product to these standards, European technical approvals or common technical specifications; (b) use of these standards, European technical approvals or common technical specifications would oblige the contracting authority to acquire 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 change-over, within a given period, to European standards, European technical approvals or common technical specifications; (c) 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 tender 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 Council Directive 89/106/EEC of 21 December 1988 on construction products (12); (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: ii(i) national standards implementing international standards accepted by the country of the contracting authority; i(ii) other national standards and national technical approvals of the country of the contracting authority; (iii) any other standard. 6. Unless such specifications are 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 undertakings. In particular, the indication of trade marks, patents, types, or of a 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 authorities awarding contracts are unable to give a description of the subject of the contract using specifications which are sufficiently precise and intelligible to all parties concerned. (13) OJ No L 40, 11. 2. 1989, p. 12.' 11. Article 11 is hereby repealed. 12. Articles 12 to 15 are replaced by the following: ´Article 12 1. Contracting authorities shall make known, by means of an indicative notice, the essential characteristics of the works contracts which they intend to award and the estimated value of which is not less than the threshold laid down in Article 4a (1). 2. Contracting authorities who wish to award a public works contract by open, restricted or negotiated procedure referred to in Article 5 (2), shall make known their intention by means of a notice. 3. Contracting authorities who wish to award a works concession contract shall make known their intention by means of a notice. 4. Works concessionaires, other than a contracting authority, who wish to award a work contract to be carried out by third parties as defined in Article 1b (4), shall make known their intention by means of a notice. 5. Contracting authorities who have awarded a contract shall make known the result by means of a notice. However, certain information on contract award may, in certain cases, not be published where release of such information would impede law enforcement or otherwise be contrary to the public interest, would prejudice the legitimate commercial interests of particular enterprises, public or private, or might prejudice fair competition between contractors. 6. The contracting authorities shall send the notices referred to in the preceding paragraphs 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 15, the notice shall be sent by telex, telegram or telefax. (a) The notice referred to in paragraph 1 shall be sent as soon as possible after the decision approving the planning of the works contracts that the contracting authorities intend to award; (b) the notice referred to in paragraph 5 shall be sent at the latest 48 days after the award of the contract in question. 7. The notices referred to in paragraphs 1, 2, 3, 4 and 5 shall be drawn up in accordance with the models given in Annexes IV, V and VI, and shall specify the information requested in those Annexes. In open, restricted and negotiated procedures, the contracting authorities may not require any conditions but those specified in Articles 25 and 26 when requesting information concerning the economic and technical standards which they require of contractors for their selection (point 11 of Annex IV B, point 10 of Annex IV C and point 9 of Annex IV D). 8. The notices referred to in paragraphs 1 and 5 above 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 original text alone being authentic. 9. The notices referred to in paragraphs 2, 3 and 4 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 other official languages of the Community, the original text alone being authentic. 10. 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 15, this period shall be reduced to five days. 11. The notice shall not be published in the official journals or in the press of the country of the contracting authority before the abovementioned date of dispatch, and it shall mention this date. It shall not contain information other than that published in the Official Journal of the European Communities. 12. The contracting authorities must be able to supply proof of the date of dispatch. 13. 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 Journal, or approximately 650 words. Each edition of the Journal containing one or more notices shall reproduce the model notice or notices on which the published notice or notices are based. Article 13 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 sending 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 a tender notice, drafted in accordance with the specimen in Annex IV A provided for in Article 12 (1), in the Official Journal of the European Communities. 3. Provided they have been requested in good time, the contract documents and supporting documents must be sent to the contractors by the contracting authorities or competent departments within six days of receiving their application. 4. Provided 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 tenders can only be made 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 paragraphs 1 and 2 shall be extended accordingly. Article 14 1. In restricted procedures and negotiated procedures as described in Article 5 (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 93 19. 7. 1989 12. (d) furnished by the candidate in accordance with Article 12 (7), or to supplement the information provided for in that Article under the same conditions as those laid down in Article 25 and 26; (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 40 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 tender notice, drafted according to the specimen in Annex IV A provided for in Article 12 (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, by telegram, telex, telefax or by 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 only be made 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 15 1. In cases where urgency renders impracticable the time limits laid down in Article 14, 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, telefax or telephone, they must be confirmed by letter dispatched before the expiry of the time limit referred to in paragraph 1.' 13. The following Articles are inserted: ´Article 15a Contracting authorities who wish to award a works concession contract as defined in Article 1 (d) shall fix a time limit for receipt of candidatures for the concession, which shall not be less than 52 days from the date of dispatch of the notice. Article 15b In works contracts awarded by a concessionaire of works other than an authority awarding contracts, the time limit for the receipt of requests to participate shall be fixed by the concessionaire at not less than 37 days from the date of dispatch of the notice, and the time limit for the receipt of tenders at not less than 40 days from the date of dispatch of the notice or the invitation to tender.' 14. Articles 16, 17 and 18 are hereby repealed. 15. Articles 19 and 20 are replaced by the following: ´Article 19 Contracting authorities may arrange for the publication in the Official Journal of the European Communities of notices announcing public works contracts which are not subject to the publication requirement laid down in this Directive. Article 20 Contracts shall be awarded on the basis of the criteria laid down in Chapter 2 of this Title, taking into account Article 20a, after the suitability of the contractors not excluded under Article 23 has been checked by the contracting authorities in accordance with the criteria of economic and financial standing and of technical knowledge or ability referred to in Articles 25 to 28.' 16. The follwing Articles are inserted: ´Article 20a Where the criterion for the award of the contract is that of the most economically advantageous tender, contracting authorities may take account of variants which are submitted by a tenderer and meet the minimum specifications required by the 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 tender notice whether variants will be considered. 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 10 (2) or again by reference to national technical specifications referred to in Article 10 (5) (a) and (b). Article 20b 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 contractor's responsibility.' 17. Article 22 is replaced by the following: ´Article 22 1. In restricted and negotiated procedures the contracting authorities shall, on the basis of information given relating to the contractor's personal 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 23 and 28 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 undertakings 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 work to be carried out. The range must number at least 5 undertakings and may be up to 20. 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 5 (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.' 18. The following Article is added: ´Article 22a 1. The contracting authority 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 are to be executed and which shall be applicable to the works carried out 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 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 is to be carried out. This shall be without prejudice to the application of the provisions of Article 29 (5) concerning the examination of abnormally low tenders.' 19. Article 24 is hereby replaced by the following: ´Article 24 Any contractor wishing to take part in a public works contract may be requested to prove his enrolment in the professional or trade register under the conditions laid down by the laws of the Member State in which he is established: - in Belgium, the registre du commerce - Handelsregister, - in Denmark, the Erhvervs- og Selskabsstyrelsen, - in Germany, the Handelsregister and the Handwerksrolle, - in Greece, a declaration on the exercise of the profession of public works contractor made on oath before a notary may be required, - in Spain, the Registro Oficial de Contratistas del Ministerio de Industria y Energia, - in France, the registre du commerce and the répertoir des métiers, - in Italy, the Registro della Camera di commercio, industria, agricoltura e artigianato, - in Luxembourg, the registre aux firmes and the rôle de la Chambre des métiers, - in the Netherlands, the Handelsregister, - in Portugal, the Commissao de Alvarás de Empresas de Obras Públicas e Particulares (CAEOPP), - in the United Kingdom and Ireland, the contractor may be requested to provide a certificate from the Registrar of Companies or the Registrar of Friendly Societies or, if this is not the case, 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 and under a given business name.' 20. Article 29 (3) is hereby repealed and Article 29 (4) and (5) replaced by the following: ´4. Paragraph 1 shall not apply when a Member State bases the award of contracts on other criteria, within the framework of rules in force at the time of the adoption of this Directive whose aim is to give preference to certain tenderers, on condition that the rules invoked are compatible with the Treaty. 5. If, for a given contract, tenders appear to be abnormally low in relation to the transaction, before it may reject those tenders the contracting authority shall 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 construction method, or the technical solutions chosen, or the exceptionally favourable conditions available to the tenderer for the execution of the work, or the originality of the work 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. However, until the end of 1992, if current national law so permits, the contracting authority may exceptionally, without any discrimination on grounds of nationality, reject tenders which are abnormally low in relation to the transaction, without being obliged to comply with the procedure provided for in the first subparagraph if the number of such tenders for a particular contract is so high that implementation of this procedure would lead to a considerable delay and jeopardize the public interest attaching to the execution of the contract in question. Recourse to this exceptional procedure shall be mentioned in the notice referred to in Article 12 (5).' 21. The following Articles are inserted in Title V: ´Article 29a 1. Until 31 December 1992, this Directive shall not prevent the application of existing national provisions on the award of public works contracts which have as their objective the reduction of regional disparities and the promotion of job creation in regions whose development is lagging behind and in declining industrial regions, on condition that the provisions concerned are compatible with the Treaty, in particular with the principles of non-discrimination on grounds of nationality, freedom of establishment and freedom to provide services, and with the Community's international obligations. 2. Paragraph 1 shall be without prejudice to Article 29 (4). Article 29b 1. Member States shall inform the Commission of national provisions covered by Article 29 (4) and Article 29a and of the rules for applying them. 2. Member States concerned shall forward to the Commission, every year, a report describing the implementation of these provisions. The reports shall be submitted to the Advisory Committee for Public Works Contracts.' 22. The following Articles are inserted: ´Article 30a 1. In order to permit assessment of the results of applying the Directive, Member States shall forward to the Commission a statistical report on the contracts awarded by contracting authorities by 31 October 1993 at the latest for the preceding year and thereafter by 31 October of every second year. Nevertheless, for the Hellenic Republic, the Kingdom of Spain and the Portuguese Republic, the date of 31 October 1993 shall be replaced by 31 October 1995. 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 work and the nationality of the contractor to whom the contract has been awarded, and in the case of negotiated procedures, subdivided in accordance with Article 5, listing the number and value of the contracts awarded to each Member State and to third countries. 3. The Commission shall determine the nature of any additional statistical information, which is requested in accordance with the Directive, in consultation with the Advisory Committee for Public Works Contracts. Article 30b 1. Annex I to this Directive shall be amended by the Commission when, in particular on the basis of the notifications from the Member States, it is necessary: (a) to remove from Annex I bodies governed by public law which no longer fulfil the criteria laid down in Article 1(b); (b) to include in that Annex bodies governed by public law which meet those criteria. 2. Amendments to Annex I shall be made by the Commission after consulting the Advisory Committee for Public Works Contracts. The chairman of the committee shall submit to the committee a draft of any measures to be taken. The committee shall deliver its opinion on the draft, if necessary by taking a vote, within a time limit to be fixed by the chairman in the light of the urgency of the matter. The opinion shall be recorded in the minutes. In addition, each Member State shall have the right to request that its position be recorded in the minutes. The Commission shall take the fullest 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. 3. Amended versions of Annex I shall be published in the Official Journal of the European Communities.' 23. Article 31 is hereby repealed. 24. Annexes I and II of Directive 71/305/EEC are replaced by Annexes I to VI of this Directive. Article 2 Directive 77/277/EEC of 26 July 1972 is hereby repealed. Article 3 Member States shall bring into force the measures necessary to comply with this Directive not later than one year after the date of its notification (14). They shall forthwith inform the Commission thereof. Nevertheless, the Hellenic Republic, the Kingdom of Spain and the Portuguese Republic shall bring into force the necessary measures so as to comply with this Directive by not later than 1 March 1992. Article 4 Member States shall ensure that the texts of the basic provisions of domestic law, whether laws, regulations or administrative provisons, which they adopt to implement with this Directive, are communicated to the Commission. Article 5 This Directive is addressed to the Member States.

31989L0465

1989

Eighteenth Council Directive 89/465/EEC of 18 July 1989 on the harmonization of the laws of the Member States relating to turnover taxes - Abolition of certain derogations provided for in Article 28 (3) of the Sixth Directive, 77/388/EEC 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 Article 28 (3) of the Sixth Council Directive, 77/388/EEC, of 17 May 1977 on the harmonization of the laws of the Member States relating to turnover taxes - Common system of value added tax: uniform basis of assessment (4), as last amended by the Act of Accession of Spain and Portugal, allows Member States to apply measures derogating from the normal rules of the common system of value added tax during a transitional period; whereas that period was originally fixed at five years; whereas the Council undertook to act, on a proposal from the Commission, before the expiry of that period, on the abolition, where appropriate, of some or all of those derogations; Whereas many of those derogations give rise, under the Communities' own resources system, to difficulties in calculating the compensation provided for in Council Regulation (EEC, Euratom) No 1553/89 of 29 May 1989 on the definitive uniform arrangements for the collection of own resources accruing from value added tax (5); whereas, in order to ensure that that system operates more efficiently, there are grounds for abolishing those derogations; Whereas the abolition of those derogations will also contribute to greater neutrality of the value added tax system at Community level; Whereas some of the said derogations should be abolished respectively from 1 January 1990, 1 January 1991, 1 January 1992 and 1 January 1993; Whereas, having regard to the provisions of the Act of Accession, the Portuguese Republic may, until 1 January 1994 at the latest, postpone the abolition of the exemption of the transactions referred to in points 3 and 9 in Annex F to Directive 77/338/EEC; Whereas it is appropriate that, before 1 January 1991, the Council should, on the basis of a Commission report, review the situation with regard to the other derogations provided for in Article 28 (3) of Directive 77/388/EEC, including the one referred to in the second subparagraph of point 1 of Article 1 of this Directive, and that it should take a decision, on a proposal from the Commission, on the abolition of these derogations, bearing in mind any distortion of competition which has resulted from their application or which may arise in connection with the future completion of the internal market, Article 1 Directive 77/388/EEC is hereby amended as follows: 1. With effect from 1 January 1990 the transactions referred to in points 1, 3 to 6, 8, 9, 10, 12, 13 and 14 of Annex E shall be abolished. Those Member States which, on 1 January 1989, subjected to value added tax the transactions listed in Annex E, points 4 and 5, are authorized to apply the conditions of Article 13A (2) (a), final indent, also to services rendered and goods delivered, as referred to in Article 13A (1) (m) and (n), where such activities are carried out by bodies governed by public law. 2. In Annex F: (a) The transactions referred to in points 3, 14 and 18 to 22 shall be abolished with effect from 1 January 1990; (b) The transactions referred to in points 4, 13, 15 and 24 shall be abolished with effect from 1 January 1991; (c) The transaction referred to in point 9 shall be abolished with effect from 1 January 1992; (d) The transaction referred to in point 11 shall be abolished with effect from 1 January 1993. Article 2 The Portuguese Republic may defer until 1 January 1994 at the latest the dates referred to in Article 1, point 2 (a), for the deletion of point 3 from Annex F and in Article 1, point 2 (c), for the deletion of point 9 from Annex F. Article 3 By 1 January 1991 the Council, on the basis of a report from the Commission, shall review the situation with regard to the other derogations laid down in Article 28 (3) of Directive 77/388/EEC, including that referred to in the second subparagraph of point 1 of Article 1 of this Directive and, acting on a Commission proposal, shall decide whether these derogations should be abolished, having regard to any distortions of competition which have resulted from their having been applied or which might arise from measures to complete the Internal Market. Article 4 In respect of the transactions referred to in Article 1, 2 and 3, Member States may take measures concerning deduction of value added tax in order totally or partially to prevent the taxable persons concerned from deriving unwarranted advantages or sustaining unwarranted disadvantages. Article 5 1. Member States shall take the necessary measures to comply with this Directive not later than the dates laid down in Article 1 and 2. 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 6 This Directive is addressed to the Member States.

31989L0458

1989

Council Directive 89/458/EEC of 18 July 1989 amending with regard to European emission standards for cars below 1,4 litres, Directive 70/220/EEC on the approximation of the laws of the Member States relating to measures to be taken against air pollution by emissions from motor vehicles 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 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 first programme of action of the European Communities on the protection of the environment, approved by the Council on 22 November 1973, called for account to be taken of the latest scientific advances in combating atmospheric pollution caused by gases emitted from motor vehicles and for Directives adopted previously to be amended accordingly; Whereas the third programme of action provides for additional efforts to be made to reduce considerably the present level of emissions of pollutants from motor vehicles; Whereas Directive 70/220/EEC (4) as last amended by Directive 88/436/EEC (5) lays down the limit values for carbon monoxide and unburnt hydrocarbon emissions from such engines; whereas these limit values were first reduced by Directive 74/290/EEC (6) and supplemented, in accordance with Directive 77/102/EEC (7), by limit values for permissible emissions of nitrogen oxides; whereas the limit values for these three pollutants were successively reduced by Directives 78/665/EEC (8), 83/351/EEC (9) and 88/76/EEC (10) and limit values for particulate pollutant emissions from diesel engines introduced by Directive 88/436/EEC; Whereas the work undertaken by the Commission in that sphere has shown that the Community has available, or is currently perfecting, technologies which allow a further reduction of the limit values in question for all engine sizes; Whereas a particular effort should be made to promote clean technologies as regards motor vehicles in the context of the research programme for the development of new technologies; ¹ ¹ ¹ ¹ ¹ ¹ Whereas in order to allow the European environment to benefit to the maximum from these provisions and at the same time ensure the unity of the market, it appears necessary to implement more stringent European standards based on total harmonization which are at least as severe as those in the United States of America and as those voted by the European Parliament; whereas these limit values are based on the current test procedures, laid down in Directive 70/220/EEC, and will need to be reconsidered when supplemented by a test representing driving conditions in extra-urban areas; Whereas in view of the major role played by pollutant emissions from motor vehicles and their contribution to the gases responsible for the greenhouse effect, their emissions of CO2 in particular must be stabilized and subsequently reduced in line with the decision of the Governing Council of the United Nations Environment Programme (UNEP) Governing Council of 24 May 1989, and in particular point 11 (d) thereof, Article 1 Annex I of Directive 70/220/EEC is hereby amended as follows: 1. In item 5.2.1.1.4., the bottom line of the table is replaced by the following: ´C< 1,400 19 5, -'. 2. In item 7.1.1.1., the bottom line of the table is replaced by the following: ´C< 1,400 22 5,8 -'. Article 2 1. From 1 January 1990 no Member State may, on grounds relating to air pollution by emission from an engine having a capacity of less than 1 400 cm=: - refuse to grant EEC type approval, to issue the document referred to in the last indent of Article 10 (1) of Directive 70/156/EEC (11) as last amended by Directive 87/403/EEC (12) or to grant national type approval for a type of motor vehicle, or - prohibit the initial entry into services of motor vehicles, where emissions from this type of motor vehicle or from such vehicles meet the provisions of Directive 70/220/EEC, as amended by this Directive. 2. From 1 July 1992, in respect of types of vehicle equipped with an engine having a capacity of less than 1 400 cm=, Member States: - may no longer issue the document provided for in the last indent of Article 10 (1) of Directive 70/156/EEC for a type of motor vehicle, - shall refuse national type approval for a type of motor vehicle, the emissions from which do not meet the requirements of the Annexes to Directive 70/220/EEC, as amended by this Directive. 3. From 31 December 1992, in respect of vehicles equipped with an engine having a capacity of less than 1 400 cm=, Member States shall prohibit the initial entry into service of vehicles the emissions from which do not meet the requirements of the Annexes to Directive 70/220/EEC, as amended by this Directive. Article 3 Member States may make provision for tax incentives for the vehicles covered by this Directive. Such incentives shall meet the provisions of the Treaty as well as the following conditions: - they shall apply to all domestic car production and to vehicles imported for marketing in a Member State and fitted with equipment allowing the European standards to be met in 1992 to be satisfied ahead of time, - they shall cease upon the date set in Article 2 (3) for the compulsory entry into force of the emission values for new vehicles, - they shall be of a value, for each type of vehicle, substantially lower than the actual cost of the equipment fitted to meet the values set and of its fitting on the vehicle. The Commission shall be informed of any plans to introduce or amend the tax incentives referred to in the first subparagraph in sufficient time to allow it to submit comments. Article 4 Member States shall bring into force the laws, regulations and administrative provisions necessary in order to comply with this Directive before 1 January 1990. They shall forthwith inform the Commission thereof. Article 5 Before the end of 1990, the Council shall, acting by a qualified majority on a proposal from the Commission decide to - also align, for vehicles equipped with an engine having a capacity equal to or more than 1 400 cm=, the dates and standards set in this Directive on the basis of an improved European test procedure including an extra-urban driving sequence, - incorporate into this improved European test procedure the limit values laid down in this Directive for vehicles equipped with an engine having a capacity of less than 1 400 cm=. Article 6 Acting by a qualified majority on a proposal from the Commission, which will take account of the results of the work in progress on the greenhouse effect, the Council shall decide on measures designed to limit CO2 emissions from motor vehicles. Article 7 This Directive is addressed to the Member States.

31989L0461

1989

Council Directive 89/461/EEC of 18 July 1989 amending, with a view to fixing certain maximum authorized dimensions for articulated vehicles, Directive 85/3/EEC on the weights, dimensions and certain other technical characteristics of certain road vehicles 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, in order to make combined vehicles more productive, manufacturers are proposing a maximum usable volume within the constraints imposed by Directive 85/3/EEC (4), as last amended by Directive 89/460/EEC (5); Whereas this increase in the usable volume involves a reduction in the space reserved for the driver and in the space between the tractive unit and the semi-trailer by means of special coupling devices; Whereas there is a consequent deterioration in the comfort and safety of the driver's working area; Whereas the current standards should be improved so as to lead to a better balance between the rational and economic use of commercial road vehicles and the requirements of road safety by making tractive units for semi-trailers more interchangeable while ensuring that drivers have enough room, Article 1 Council Directive 85/3/EEC is hereby amended as follows: 1. The following Article is inserted: ´Article 4a Articulated vehicles put into circulation before 1 January 1991 which do not comply with the new specifications contained in points 1.6 and 4.4 of Annex I shall be deemed to comply with such specifications for the purposes of Article 3 (1) if they do not exceed the total length of 15,50 metres.' 2. Point 1.1 of Annex I is replaced by the following: ´1.1 Maximum length - motor vehicle12,00 metres'. - trailer12,00 metres'. - articulated vehicle16,50 metres'. - road train18,00 metres'. - articulated bus18,00 metres'. 3. The following point is inserted in Annex I: ´1.6. Maximum distance betwen the axis of the fifth-wheel king pin and the rear of a semi-trailer12,00 metres'. 4. The following point is inserted in Annex I: ´4.4. Semi-trailers: The distance measured horizontally between the axis of the fifth-wheel king pin and any point at the front of the semi-trailer must not exceed 2,04 metres'. Article 2 After consulting the Commission, the Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1991. 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 3 This Directive is addressed to the Member States.

31989L0517

1989

Commission Directive 89/517/EEC of 1 August 1989 adapting to technical progress Council Directive 76/761/EEC on the approximation of the laws of the Member States relating to motor-vehicle headlamps which function as main-beam and/or dipped-beam headlamps and to incandescent electric filament lamps for such headlamps Having regard to the Treaty establishing the European Economic Community, Having regard to 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 (1), as last amended by Directive 87/403/EEC (2), and in particular Article 11 thereof, Having regard to Council Directive 76/761/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to motor-vehicle headlamps which function as main-beam and/or dipped-beam headlamps and to incandescent electric filament lamps for such headlamps (3), as last amended by Directive 87/354/EEC (4), and in particular Article 10 thereof, Whereas, in the light of experience and in view of the current state of the art, certain requirements may now be supplemented and brought more into line with real traffic conditions, thus improving the safety of vehicle occupants and other road users; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of Directives on the Removal of Technical Barriers to Trade in the Motor Vehicles Sector, Article 1 The list of Annexes and Annexes I, II, V and VI to Directive 76/761/EEC shall be amended in accordance with the Annex to this Directive. A new Annex VII, also set out in the Annex to this Directive, shall be added. Article 2 1. With effect from 1 January 1990, no Member State may: (a) - refuse, in respect of a type of vehicle, to grant EEC type-approval, to issue the document referred to in the third indent of Article 10 (1) of Directive 70/156/EEC, or to grant national type-approval, or - prohibit the entry into service of vehicles, on grounds relating to the headlamps which function as main-beam and/or dipped-beam headlamps and to the incandescent electric filament lamps for such lamps, hereinafter referred to as ´headlamps' and ´lamps' respectively, if the latter comply with the provisions of this Directive; (b) - refuse to grant EEC component type-approval or national component type-approval in respect of the said headlamps and lamps if they comply with the provisions of this Directive, or - prohibit the placing on the market of headlamps and lamps if the latter bear the EEC component type-approval mark issued in accordance with the provisions of this Directive. 2. With effect from 1 July 1990, Member States: (a) - shall not issue the document referred to in the third indent of Article 10 (1) of Directive 70/156/EEC in respect of a type of vehicle of which the headlamps and lamps do not comply with the provisions of this Directive, - may refuse to grant national type-approval in respect of a type of vehicle of which the said headlamps and lamps do not comply with the provisions of this Directive; (b) - shall not grant EEC component type-approval in respect of headlamps and lamps if the latter do not comply with the provisions of this Directive, - may refuse to grant national component type-approval in respect of the said headlamps and lamps if they do not comply with the provisions of this Directive. 3. With effect from 1 April 1994, Member States may prohibit the entry into service of vehicles of which the headlamps and lamps do not comply with the provisions of this Directive, and the placing on the market of headlamps and lamps which do not bear the type-approval mark issued in accordance with the provisions of this Directive. 4. By way of derogation from the provisions of 2 (b) above, Member States shall continue to recognize EEC component type-approval granted for a type of headlamp and a type of lamp pursuant to the provisions of Directive 76/761/EEC which are intended to be mounted on vehicles already in service. Article 3 Member States shall bring into force the provisions necessary to comply with this Directive not later than 31 December 1989. They shall forthwith inform the Commission thereof. The provisions adopted pursuant to the first subparagraph shall make express reference to this Directive. Article 4 This Directive is addressed to the Member States.

31989L0518

1989

Commission Directive 89/518/EEC of 1 August 1989 adapting to technical progress Council Directive 77/538/EEC on the approximation of the laws of the Member States relating to rear fog lamps for motor vehicles and their trailers Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 70/156/EE 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 (1), as last amended by Directive 87/403/EEC (2), and in particular Article 11 thereof, Having regard to Council Directive 77/538/EEC of 28 June 1977 on the approximation of the laws of the Member States relating to rear fog lamps for motor vehicles and their trailers (3), as last amended by Directive 87/354/EEC (4), and in particular Article 10 thereof, Whereas, in the light of experience and in view of the current state of the art, it is now possible to simplify the EEC component type-approval mark for such lamps, where they are grouped together with, combined with or reciprocally incorporated in other lamps; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of Directives on the Removal of Technical Barriers to Trade in the Motor Vehicles Sector, Article 1 Annexes 0 and II to Directive 77/538/EEC are amended in accordance with the Annex to this Directive. Article 2 With effect from 1 January 1990, no Member State may: (a) - refuse, in respect of a type of vehicle, to grant EEC type-approval, to issue the document referred to in the third indent of Article 10 (1) of Directive 70/156/EEC, or to grant national type-approval, or - prohibit the entry into service of vehicles, on grounds relating to the rear fog lamps if the latter comply with the provisions of this Directive; (b) - refuse to grant EEC component type-approval or national component type-approval in respect of the said rear fog lamps if they comply with the provisions of this Directive, or - prohibit the placing on the market of rear fog lamps if the latter bear the EEC component type-approval mark issued in accordance with the provisions of this Directive. Article 3 Member States shall bring into force the provisions necessary to comply with this Directive not later than 31 December 1989. They shall forthwith inform the Commission thereof. The provisions adopted pursuant to the first subparagraph shall make express reference to this Directive. Article 4 This Directive is addressed to the Member States.

31989L0519

1989

Commission Directive 89/519/EEC of 1 August 1989 supplementing and amending Directive 77/535/EEC on the approximation of the laws of Member States relating to methods of sampling and analysis for fertilizers 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 Council Directive 89/284/EEC (2), and in particular Article 9 (2) thereof, Whereas Directive 89/284/EEC supplements and amends Directive 76/116/EEC in respect of the calcium, magnesium, sodium and sulphur content of fertilizers; Whereas Commission Directive 77/535/EEC (3), as last amended by Directive 87/566/EEC (4), provides for official controls for EEC fertilizers for the purpose of checking compliance with the requirements imposed by the Community provisions concerning the quality and composition of fertilizers; whereas that Directive should be supplemented so that fertilizers to which Council Directive 89/284/EEC relates can also be checked; whereas it is necessary to replace methods 5.1, 5.2, 5.3 and 5.4; whereas general provisions relating to methods for analysing fertilizers applicable to all methods should be added to the general observations of Annex II; 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 1. General provisions relating to methods for analysing fertilizers of Annex I to this Directive are added to the general observations of Annex II to Directive 77/535/EEC. 2. The methods 8.1 to 8.10 in Annex II to this Directive are added to Annex II to Directive 77/535/EEC. 3. Methods 5.1 to 5.4 set out in Annex II to Directive 77/535/EEC are deleted. Article 2 1. Member States shall take measures necessary to comply with this Directive by 1 September 1990 and shall forthwith inform the Commission thereof. The provisions adopted pursuant to the first indent shall make express reference to this Directive. 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.

31989L0516

1989

Commission Directive 89/516/EEC of 1 August 1989 adapting to technical progress Council Directive 76/758/EEC on the approximation of the laws of the Member States relating to the end-outline marker lamps, front position (side) lamps, rear position (side) lamps and stop lamps for motor vehicles and their trailers Having regard to the Treaty establishing the European Economic Community, Having regard to 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 (1), as last amended by Directive 87/403/EEC (2), and in particular Article 11 thereof, Having regard to Council Directive 76/758/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to the end-outline marker lamps, front position (side) lamps, rear position (side) lamps and stop lamps for motor vehicles and their trailers (3), as last amended by Directive 87/354/EEC (4), and in particular Article 10 thereof, Whereas, in the light of experience, it is now possible to simplify the EEC component type-approval mark for lamps of this type when these are grouped together with, combined with or reciprocally incorporated in other lamps, and to amend certain provisions to take account of the technical progress made in the meantime;. Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of Directives on the Removal of Technical Barriers to Trade in the Motor Vehicles Sector, Article 1 The list of Annexes and Annexes 0, I, II and III to Directive 76/758/EEC are hereby amended as set out in the Annex to this Directive. Article 2 1. With effect from 1 January 1990, no Member State may: (a) - refuse, in respect of a type of motor vehicle, to grant EEC type-approval, to issue the document referred to in the third indent of Article 10 (1) of Directive 70/156/EEC, or to grant national type-approval, or - prohibit the entry into service of the vehicles, if the end-outline marker lamps, front position (side) lamps, rear position (side) lamps and stop lamps comply with the provisions of this Directive; (b) - refuse, in respect of a type of end-outline marker lamp, front position (side) lamp, rear position (side) lamp and stop lamp, to grant EEC component type-approval or national type-approval, if these end-outline marker lamps, front position (side) lamps, rear position (side) lamps and stop lamps comply with the provisions of this Directive, or - prohibit the placing on the market of end-outline marker lamps, front position (side) lamps, rear position (side) lamps and stop lamps which bear the EEC component type-approval mark issued in accordance with the requirements of this Directive. 2. With effect from 1 July 1990 a Member State: (a) - shall not issue the document referred to in the third indent of Article 10 (1) of Directive 70/156/EEC in respect of a type of vehicle of which the end-outline marker lamps, front position (side) lamps, rear position (side) lamps and stop lamps do not comply with the provisions of this Directive, - may refuse to grant national type-approval in respect of a type of vehicle of which the end-outline marker lamps, front position (side) lamps, rear position (side) lamps and stop lamps do not comply with the provisions of this Directive; (b) - shall not grant EEC component type-approval in respect of a type of end-outline marker lamp, front position (side) lamp, rear position (side) lamp and stop lamp if the latter does not comply with the provisions of this Directive, - may refuse to grant national component type-approval in respect of a type of end-outline marker lamp, front position (side) lamp, rear positon (side) lamp and stop lamp if the latter does not comply with the provisions of this Directive. 3. With effect from 1 October 1995, Member States may prohibit the entry into service of vehicles of which the end-outline marker lamps, front position (side) lamps, rear position (side) lamps and stop lamps do not comply with the provisions of this Directive and the placing on the market of those lamps which do not bear the component type-approval mark issued in accordance with the requirements of this Directive. 4. By way of derogation from the provisions of 2 (b) above, Member States shall continue to recognize EEC component type-approval granted for a type of end-outline marker lamp, front position (side) lamp, rear position (side) lamp or stop lamp pursuant to the provisions of Directive 76/758/EEC in the case of devices intended to be mounted on vehicles already in service, and may also grant EEC component type-approval for a type of end-outline marker lamp, front position (side) lamp, rear position (side) lamp or stop lamp pursuant to the provisions of Directive 76/758/EEC provided that such devices are intended to be used as replacement parts for vehicles already in service and it is not technically possible for the said devices to comply with the provisions of this Directive. Article 3 Member States shall bring into force the provisions necessary to comply with this Directive not later than 31 December 1989. They shall forthwith inform the Commission thereof. The provisions adopted pursuant to the first subparagraph shall make express reference to this Directive. Article 4 This Directive is addressed to the Member States.

31989L0514

1989

Commission Directive 89/514/EEC of 2 August 1989 adapting to technical progress Council Directive 86/662/EEC on the limitation of noise emitted by hydraulic excavators, rope-operated excavators, dozers, loaders and excavator-loaders Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 86/662/EEC of 22 December 1986 on the limitation of noise emitted by hydraulic excavators, rope-operated excavators, dozers, loaders and excavator-loaders (1), and in particular Article 8, first indent, thereof, Whereas, in view of the experience gained, the present state of technical progress and the international standardization work that has been carried out it is now necessary to adapt the provisions of Annex II to Directive 86/662/EEC in order to take into account the most recent advances; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on Adaptation to Technical Progress set up under the Directive relating to the determination of the noise emission of construction plant and equipment, which is competent to adapt the Annexes to Directive 86/662/EEC, and in particular to adopt the real, dynamic measurement method referred to in Annex II to that Directive, Article 1 Annex II to Directive 86/662/EEC is hereby replaced by the Annex to this Directive. Article 2 Member States shall bring into force the necessary provisions in order to comply with this Directive by 1 January 1990 and shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31989L0520

1989

Commission Directive 89/520/EEC of 6 September 1989 amending the Annex to 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 1982 concerning certain products used in animal nutrition (1), as last amended by Directive 88/485/EEC (2), and in particular Article 6 thereof, Whereas Directive 82/471/EEC provides for regular amendment of the Annex thereto as a result of developments in scientific or technical knowledge; Whereas the study of a new product belonging to the amino acids group has shown that this product satisfies the requirements of Directive 82/471/EEC; whereas the use of this product in animal nutrition should, therefore, be permitted under certain conditions; Whereas it has been found necessary to alter the composition characteristics and special provisions laid down in the Annex for 'Hydroxyanalogues of amino acids'; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs, Article 1 The Anex to Directive 82/471/EEC is amended as set out in the Annex hereto. Article 2 The Member State shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1990. The provisions adopted pursuant to the first paragraph shall make express reference to this Directive. They shall immediately inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31989L0530

1989

Council Directive 89/530/EEC of 18 September 1989 supplementing and amending Directive 76/116/EEC in respect of the trace elements boron, cobalt, copper, iron, manganese, molybdenum and zinc contained in fertilizers 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 necessary to adopt measures 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 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 89/284/EEC (2), lays down rules on the marketing of EEC-type fertilizers; whereas it has proved necessary to extend this Directive to cover the seven trace elements (boron, cobalt, copper, iron, manganese, molybdenum and zinc) contained in these fertilizers; Whereas Directive 76/116/EEC should henceforth apply to soluble fertilizers or fluids containing one or more trace elements marketed individually and mixtures thereof and to certain chelated trace elements; Whereas the Directives on fertilizers should be continually developed and updated as regards the adaptation to scientific and technical progress of the products listed in the Annexes to those Directives; whereas for this purpose it is considered necessary to extend the functions of the Committee provided for in Directive 76/116/EEC, Article 1 1. Solid or fluid fertilizers listed in Chapter A of the Annex, containing only one of the following trace elements: boron, cobalt, copper, iron, manganese, molybdenum or zinc and meeting the requirements of the said Chapter A, may be marked 'EEC FERTILIZER'. 2. Mixtures of two or more of the fertilizers referred to in paragraph 1 containing at least two different trace elements may be marked 'EEC FERTILIZER' if they meet the requirements of Chapter B of the Annex. Article 2 EEC fertilizers complying with the provisions of Article 1 shall be packaged. Article 3 1. The content of one or more of the following trace elements: boron, cobalt, copper, iron, manganese, molybdenum or zinc in the EEC fertilizers listed in Annex I to Directive 76/116/EEC shall be declared where the following two conditions are fulfilled: (a) the trace elements are added and present at least in the minimum quantities specified in Chapters C and D of the Annex to this Directive; (b) the EEC fertilizers must continue to satisfy the requirements of Annex I to Directive 76/116/EEC. 2. Where the trace elements are the normal ingredients of the raw materials intended to supply major and secondary elements, their declaration shall be optional, provided that these trace elements are present at least in the minimum quantities specified in Chapters C and D of the Annex to this Directive. Article 4 The compulsory markings for the identification of the fertilizers covered by this Directive shall be as follows: (a) 'EEC FERTILIZER' in capital letters, (b) the designation of the type of fertilizer: - either in accordance with Chapter A of the Annex, - or as the type designation 'Mixture of trace elements', followed by the names of the trace elements present or their chemical symbols, - or in accordance with Annex I to Directive 76/116/EEC, by adding to the type designation either: 'with trace elements', or 'with' followed by the name or names of the trace elements present or by their chemical symbols. Only the numbers stating the contents of the major and secondary elements covered by Directive 76/116/EEC shall follow the type designation. Where several trace elements are present they shall be listed in the alphabetical of their chemical symbols: B, Co, Cu, Fe, Mn, Mo, Zn; (c) the guaranteed content in respect of each nutrient and the guaranteed content expressed as forms and/or solubilities where these are specified in the Annexes to Directive 76/116/EEC and, for each trace element present, as required by Article 6; (d) where all or part of the trace element is chemically linked with an organic molecule, the name of that element is then followed by one of the following qualifiers: - 'chelated by . . .' (name of chelating agent or its abbreviation as set out in Chapter E (1) of the Annex), - 'complexed by . . .' (name of complexing agent as set out in Chapter E (2) of the Annex). The trace-element content shall be expressed as a percentage by weight, in whole numbers or where necessary to one decimal place for fertilizers containing only one trace element (Chapter A of the Annex). Where fertilizers contain several trace elements the number of decimal places may, for a given element, be as set out in Chapters B, C and D of the Annex. Trace-element content shall be expressed both in words and by the appropriate chemical symbols. The following shall be entered on the label or accompanying papers, with regard to the products appearing in Chapters A and B of the Annex below the obligatory or optional declarations: 'To be used only where there is a recognized need. Do not exceed the appropriate dose rates.' Article 5 Member States may require on their territory without impeding trade and on the responsiblity of the person in charge of marketing that an indication be given of the dose rates and conditions of use suitable for the soil and crop conditions under which the fertilizer is used. This information must be clearly separated from the obligatory declarations provided for in Article 4. Article 6 Member States shall require that the trace-element content of EEC fertilizers placed on the market must be stated in the form of elements (B, Co, Cu, Fe, Mn, Mo, Zn). The trace-element content of a fertilizer shall be declared in the following manner: (a) for the fertilizers referred to in Article 1 (1): in accordance with the requirements set out in Chapter A (column 6) of the Annex; (b) for the fertilizers referred to in Article 1 (2) and Article 3 by indicating: - the total content, expressed as a percentage by weight of the fertilizer, and - the water-soluble content, expressed as a percentage by weight of the fertilizer, where that solubility is at least half of the total content. Where a trace-element is totally water-soluble, only the water-soluble content shall be declared. The trace-element content of a fertilizer shall be determined under the conditions laid down in the methods of analysis provided for in Article 8 of Directive 76/116/EEC. Where a trace element is chemically linked with an organic molecule the content present in the fertilizer shall be declared immediately following the water-soluble content as a percentage by weight of the product, followed by one of the terms: 'chelated by' or 'complexed by' with the name of the organic molecule as set out in Chapter E of the Annex. The name of the organic molecule may be replaced by its initials. Article 7 The tolerance allowed in respect of the declared trace-element content shall be: - 0,4 % in absolute terms for a content of more than 2 %, - one-fifth of the declared value for a content not exceeding 2 %. Article 8 Article 9 (1) of Directive 76/116/EEC is replaced by the following: 'Amendments required to adapt the Annexes to technical progress shall be adopted in accordance with the procedure laid down in Article 11. Where such amendments are made, a fertilizer shall be included only if: (a) it does not adversely affect human or animal health or the environment; (b) it provides nutrients in an effective manner according to the needs of a particular crop or according to growing conditions of particular crops.' Article 9 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within eighteen months of its notification. They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive. Article 10 This Directive is addressed to the Member States.

31989L0552

1989

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 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), Whereas the objectives of the Community as laid down in the Treaty include establishing an even closer union among the peoples of Europe, fostering closer relations between the States belonging to the Community, ensuring the economic and social progress of its countries by common action to eliminate the barriers which divide Europe, encouraging the constant improvement of the living conditions of its peoples as well as ensuring the preservation and strengthening of peace and liberty; Whereas the Treaty provides for the establishment of a common market, including the abolition, as between Member States, of obstacles to freedom of movement for services and the institution of a system ensuring that competition in the common market is not distorted; Whereas broadcasts transmitted across frontiers by means of various technologies are one of the ways of pursuing the objectives of the Community; whereas measures should be adopted to permit and ensure the transition from national markets to a common programme production and distribution market and to establish conditions of fair competition without prejudice to the public interest role to be discharged by the television broadcasting services; Whereas the Council of Europe has adopted the European Convention on Transfrontier Television; Whereas the Treaty provides for the issuing of directives for the coordination of provisions to facilitate the taking up of activities as self-employed persons; Whereas television broadcasting constitutes, in normal circumstances, a service within the meaning of the Treaty; Whereas the Treaty provides for free movement of all services normally provided against payment, without exclusion on grounds of their cultural or other content and without restriction of nationals of Member States established in a Community country other than that of the person for whom the services are intended; Whereas this right as applied to the broadcasting and distribution of television services is also a specific manifestation in Community law of a more general principle, namely the freedom of expression as enshrined in Article 10 (1) of the Convention for the Protection of Human Rights and Fundamental Freedoms ratified by all Member States; whereas for this reason the issuing of directives on the broadcasting and distribution of television programmes must ensure their free movement in the light of the said Article and subject only to the limits set by paragraph 2 of that Article and by Article 56 (1) of the Treaty; Whereas the laws, regulations and administrative measures in Member States concerning the pursuit of activities as television broadcasters and cable operators contain disparities, some of which may impede the free movement of broadcasts within the Community and may distort competition within the common market; Whereas all such restrictions on freedom to provide broadcasting services within the Community must be abolished under the Treaty; Whereas such abolition must go hand in hand with coordination of the applicable laws; whereas this coordination must be aimed at facilitating the pursuit of the professional activities concerned and, more generally, the free movement of information and ideas within the Community; Whereas it is consequently necessary and sufficient that all broadcasts comply with the law of Member State from which they emanate; Whereas this Directive lays down the minimum rules needed to guarantee freedom of transmission in broadcasting; whereas, therefore, it does not affect the responsibility of the Member States and their authorities with regard to the organization - including the systems of licensing, administrative authorization or taxation - financing and the content of programmes; whereas the independence of cultural developments in the Member States and the preservation of cultural diversity in the Community therefore remain unaffected; Whereas it is necessary, in the common market, that all broadcasts emanating from and intended for reception within the Community and in particular those intended for reception in another Member State, should respect the law of the originating Member State applicable to broadcasts intended for reception by the public in that Member State and the provisions of this Directive; Whereas the requirement that the originating Member State should verify that broadcasts comply with national law as coordinated by this Directive is sufficient under Community law to ensure free movement of broadcasts without secondary control on the same grounds in the receiving Member States; whereas, however, the receiving Member State may, exceptionally and under specific conditions provisionally suspend the retransmission of televised broadcasts; Whereas it is essential for the Member States to ensure the prevention of any acts which may prove detrimental to freedom of movement and trade in television programmes or which may promote the creation of dominant positions which would lead to restrictions on pluralism and freedom of televised information and of the information sector as a whole; Whereas this Directive, being confined specifically to television broadcasting rules, is without prejudice to existing or future Community acts of harmonization, in particular to satisfy mandatory requirements concerning the protection of consumers and the fairness of commercial transactions and competition; Whereas co-ordination is nevertheless needed to make it easier for persons and industries producing programmes having a cultural objective to take up and pursue their activities; Whereas minimum requirements in respect of all public or private Community television programmes for European audio-visual productions have been a means of promoting production, independent production and distribution in the abovementioned industries and are complementary to other instruments which are already or will be proposed to favour the same objective; Whereas it is therefore necessary to promote markets of sufficient size for television productions in the Member States to recover necessary investments not only by establishing common rules opening up national markets but also by envisaging for European productions where practicable and by appropriate means a majority proportion in television programmes of all Member States; whereas, in order to allow the monitoring of the application of these rules and the pursuit of the objectives, Member States will provide the Commission with a report on the application of the proportions reserved for European works and independent productions in this Directive; whereas for the calculation of such proportions account should be taken of the specific situation of the Hellenic Republic and the Portuguese Republic; whereas the Commission must inform the other Member States of these reports accompanied, where appropriate by an opinion taking account of, in particular, progress achieved in relation to previous years, the share of first broadcasts in the programming, the particular circumstances of new television broadcasters and the specific situation of countries with a low audio-visual production capacity or restricted language area; Whereas for these purposes 'European works' should be defined without prejudice to the possibility of Member States laying down a more detailed definition as regards television broadcasters under their jurisdiction in accordance with Article 3 (1) in compliance with Community law and account being taken of the objectives of this Directive; Whereas it is important to seek appropriate instruments and procedures in accordance with Community law in order to promote the implementation of these objectives with a view to adopting suitable measures to encourage the activity and development of European audio-visual production and distribution, particularly in countries with a low production capacity or restricted language area; Whereas national support schemes for the development of European production may be applied in so far as they comply with Community law; Whereas a commitment, where practicable, to a certain proportion of broadcasts for independent productions, created by producers who are independent of broadcasters, will stimulate new sources of television production, especially the creation of small and medium-sized enterprises; whereas it will offer new opportunities and outlets to the marketing of creative talents of employment of cultural professions and employees in the cultural field; whereas the definition of the concept of independent producer by the Member States should take account of that objective by giving due consideration to small and medium-sized producers and making it possible to authorize financial participation by the coproduction subsidiaries of television organizations; Whereas measures are necessary for Member States to ensure that a certain period elapses between the first cinema showing of a work and the first television showing; Whereas in order to allow for an active policy in favour of a specific language, Member States remain free to lay down more detailed or stricter rules in particular on the basis of language criteria, as long as these rules are in conformity with Community law, and in particular are not applicable to the retransmission of broadcasts originating in other Member States; Whereas in order to ensure that the interests of consumers as television viewers are fully and properly protected, it is essential for television advertising to be subject to a certain number of minimum rules and standards and that the Member States must maintain the right to set more detailed or stricter rules and in certain circumstances to lay down different conditions for television broadcasters under their jurisdiction; Whereas Member States, with due regard to Community law and in relation to broadcasts intended solely for the national territory which may not be received, directly or indirectly, in one or more Member States, must be able to lay down different conditions for the insertion of advertising and different limits for the volume of advertising in order to facilitate these particular broadcasts; Whereas it is necessary to prohibit all television advertising promoting cigarettes and other tobacco products including indirect forms of advertising which, whilst not directly mentioning the tobacco product, seek to circumvent the ban on advertising by using brand names, symbols or other distinctive features of tobacco products or of undertakings whose known or main activities include the production or sale of such products; Whereas it is equally necessary to prohibit all television advertising for medicinal products and medical treatment available only on prescription in the Member State within whose jurisdiction the broadcaster falls and to introduce strict criteria relating to the television advertising of alcoholic products; Whereas in view of the growing importance of sponsorship in the financing of programmes, appropriate rules should be laid down; Whereas it is, furthermore, necessary to introduce rules to protect the physical, mental and moral development of minors in programmes and in television advertising; Whereas although television broadcasters are normally bound to ensure that programmes present facts and events fairly, it is nevertheless important that they should be subject to specific obligations with respect to the right of reply or equivalent remedies so that any person whose legitimate interests have been damaged by an assertion made in the course of a broadcast television programme may effectively exercise such right or remedy. CHAPTER I Definitions Article 1 For the purpose of this Directive: (a) 'television broadcasting' means the initial transmission by wire or over the air, including that by satellite, in unencoded or encoded form, of television programmes intended for reception by the public. It includes the communication of programmes between undertakings with a view to their being relayed to the public. It does not include communication services providing items of information or other messages on individual demand such as telecopying, electronic data banks and other similar services; (b) 'television advertising' means any form of announcement broadcast in return for payment or for similar consideration by a public or private undertaking in connection with a trade, business, craft or profession in order to promote the supply of goods or services, including immovable property, or rights and obligations, in return for payment. (1) OJ No C 179, 17. 7. 1986, p. 4. (2) OJ No C 49, 22. 2. 1988, p. 53, and OJ No C 158, 26. 6. 1989. (3) OJ No C 232, 31. 8. 1987, p. 29. Except for the purposes of Article 18, this does not include direct offers to the public for the sale, purchase or rental of products or for the provision of services in return for payment; (c) 'surreptitious advertising' means the representation in words or pictures of goods, services, the name, the trade mark or the activities of a producer of goods or a provider of services in programmes when such representation is intended by the broadcaster to serve advertising and might mislead the public as to its nature. Such representation is considered to be intentional in particular if it is done in return for payment or for similar consideration; (d) 'sponsorship' means any contribution made by a public or private undertaking not engaged in television broadcasting activities or in the production of audio-visual works, to the financing of television programmes with a view to promoting its name, its trade mark, its image, its activities or its products. CHAPTER II General provisions Article 2 1. Each Member State shall ensure that all television broadcasts transmitted - by broadcasters under its jurisdiction, or - by broadcasters who, while not being under the jurisdiction of any Member State, make use of a frequency or a satellite capacity granted by, or a satellite up-link situated in, that Member State, comply with the law applicable to broadcasts intended for the public in that Member State. 2. Member States shall ensure freedom of reception and shall not restrict retransmission on their territory of television broadcasts from other Member States for reasons which fall within the fields coordinated by this Directive. Member States may provisonally suspend retransmissions of television broadcasts if the following conditions are fulfilled: (a) a television broadcast coming from another Member State manifestly, seriously and gravely infringes Article 22; (b) during the previous 12 months, the broadcaster has infringed the same provision on at least two prior occasions; (c) the Member State concerned has notified the broadcaster and the Commission in writing of the alleged infringements and of its intention to restrict retransmission should any such infringement occur again; (d) consultations with the transmitting State and the Commission have not produced an amicable settlement within 15 days of the notification provided for in point (c), and the alleged infringement persists. The Commission shall ensure that the suspension is compatible with Community law. It may ask the Member State concerned to put an end to a suspension which is contrary to Community law, as a matter of urgency. This provision is without prejudice to the application of any procedure, remedy or sanction to the infringements in question in the Member State which has jurisdiction over the broadcaster concerned. 3. This Directive shall not apply to broadcasts intended exclusively for reception in States other than Member States, and which are not received directly or indirectly in one or more Member States. Article 3 1. Member States shall remain free to require television broadcasters under their jurisdiction to lay down more detailed or stricter rules in the areas covered by this Directive. 2. Member States shall, by appropriate means, ensure, within the framework of their legislation, that television broadcasters under their jurisdiction comply with the provisions of this Directive. CHAPTER III Promotion of distribution and production of television programmes Article 4 1. Member States shall ensure where practicable and by appropriate means, that broadcasters reserve for European works, within the meaning of Article 6, a majority proportion of their transmission time, excluding the time appointed to news, sports events, games, advertising and teletext services. This proportion, having regard to the broadcaster's informational, educational, cultural and entertainment responsibilities to its viewing public, should be achieved progressively, on the basis of suitable criteria. 2. Where the proportion laid down in paragraph 1 cannot be attained, it must not be lower than the average for 1988 in the Member State concerned. However, in respect of the Hellenic Republic and the Portuguese Republic, the year 1988 shall be replaced by the year 1990. 3. From 3 October 1991, the Member States shall provide the Commission every two years with a report on the application of this Article and Article 5. That report shall in particular include a statistical statement on the achievement of the proportion referred to in this Article and Article 5 for each of the television programmes falling within the jurisdiction of the Member State concerned, the reasons, in each case, for the failure to attain that proportion and the measures adopted or envisaged in order to achieve it. The Commission shall inform the other Member States and the European Parliament of the reports, which shall be accompanied, where appropriate, by an opinion. The Commission shall ensure the application of this Article and Article 5 in accordance with the provisions of the Treaty. The Commission may take account in its opinion, in particular, of progress achieved in relation to previous years, the share of first broadcast works in the programming, the particular circumstances of new television broadcasters and the specific situation of countries with a low audiovisual production capacity or restricted language area. 4. The Council shall review the implementation of this Article on the basis of a report from the Commission accompanied by any proposals for revision that it may deem appropriate no later than the end of the fifth year from the adoption of the Directive. To that end, the Commission report shall, on the basis of the information provided by Member States under paragraph 3, take account in particular of developments in the Community market and of the international context. Article 5 Member States shall ensure, where practicable and by appropriate means, that broadcasters reserve at least 10 % of their transmission time, excluding the time appointed to news, sports events, games, advertising and teletext services, or alternately, at the discretion of the Member State, at least 10 % of their programming budget, for European works created by producers who are independent of broadcasters. This proportion, having regard to broadcasters' informational, educational, cultural and entertainment responsibilities to its viewing public, should be achieved progressively, on the basis of suitable criteria; it must be achieved by earmarking an adequate proportion for recent works, that is to say works transmitted within five years of their production. Article 6 1. Within the meaning of this chapter, 'European works' means the following: (a) works originating from Member States of the Community and, as regards television broadcasters falling within the jurisdiction of the Federal Republic of Germany, works from German territories where the Basic Law does not apply and fulfilling the conditions of paragraph 2; (b) works originating from European third States party to the European Convention on Transfrontier Television of the Council of Europe and fulfilling the conditions of paragraph 2; (c) works originating from other European third countries and fulfilling the conditions of paragraph 3. 2. The works referred to in paragraph 1 (a) and (b) are works mainly made with authors and workers residing in one or more States referred to in paragraph 1 (a) and (b) provided that they comply with one of the following three conditions: (a) they are made by one or more producers established in one or more of those States; or (b) production of the works is supervised and actually controlled by one or more producers established in one or more of those States; or (c) the contribution of co-producers of those States to the total co-production costs is preponderant and the co-production is not controlled by one or more producers established outside those States. 3. The works referred to in paragraph 1 (c) are works made exclusively or in co-production with producers established in one or more Member State by producers established in one or more European third countries with which the Community will conclude agreements in accordance with the procedures of the Treaty, if those works are mainly made with authors and workers residing in one or more European States. 4. Works which are not European works within the meaning of paragraph 1, but made mainly with authors and workers residing in one or more Member States, shall be considered to be European works to an extent corresponding to the proportion of the contribution of Community co-producers to the total production costs. Article 7 Member States shall ensure that the television broadcasters under their jurisdiction do not broadcast any cinematographic work, unless otherwise agreed between its rights holders and the broadcaster, until two years have elapsed since the work was first shown in cinemas in one of the Member States of the Community; in the case of cinematographic works co-produced by the broadcaster, this period shall be one year. Article 8 Where they consider it necessary for purposes of language policy, the Member States, whilst observing Community law, may as regards some or all programmes of television broadcasters under their jurisdiction, lay down more detailed or stricter rules in particular on the basis of language criteria. Article 9 This chapter shall not apply to local television broadcasts not forming part of a national network. CHAPTER IV Television advertising and sponsorship Article 10 1. Television advertising shall be readily recognizable as such and kept quite separate from other parts of the programme service by optical and/or acoustic means. 2. Isolated advertising spots shall remain the exception. 3. Advertising shall not use subliminal techniques. 4. Surreptitious advertising shall be prohibited. Article 11 1. Advertisements shall be inserted between programmes. Provided the conditions contained in paragraphs 2 to 5 of this Article are fulfilled, advertisements may also be inserted during programmes in such a way that the integrity and value of the programme, taking into account natural breaks in and the duration and nature of the programme, and the rights of the rights holders are not prejudiced. 2. In programmes consisting of autonomous parts, or in sports programmes and similarly structured events and performances comprising intervals, advertisements shall only be inserted between the parts or in the intervals. 3. The transmission of audiovisual works such as feature films and films made for television (excluding series, serials, light entertainment programmes and documentaries), provided their programmed duration is more than 45 minutes, may be interrupted once for each complete period of 45 minutes. A further interruption is allowed if their programmed duration is at least 20 minutes longer than two or more complete periods of 45 minutes. 4. Where programmes, other than those covered by paragraph 2, are interrupted by advertisements, a period of at least 20 minutes should elapse between each successive advertising break within the programme. 5. Advertisements shall not be inserted in any broadcast of a religious service. News and current affairs programmes, documentaries, religious programmes, and children's programmes, when their programmed duration is less than 30 minutes shall not be interrupted by advertisements. If their programmed duration is of 30 minutes or longer, the provisions of the previous paragraphs shall apply. Article 12 Television advertising shall not: (a) prejudice respect for human dignity: (b) include any discrimination on grounds of race, sex or nationality; (c) be offensive to religious or political beliefs; (d) encourage behaviour prejudicial to health or to safety; (e) encourage behaviour prejudicial to the protection of the environment. Article 13 All forms of television advertising for cigarettes and other tobacco products shall be prohibited. Article 14 Television advertising for medicinal products and medical treatment available only on prescription in the Member State within whose jurisdiction the broadcaster falls shall be prohibited. Article 15 Television advertising for alcoholic beverages shall comply with the following criteria: (a) it may not be aimed specifically at minors or, in particular, depict minors consuming these beverages; (b) it shall not link the consumption of alcohol to enhanced physical performance or to driving; (c) it shall not create the impression that the consumption of alcohol contributes towards social or sexual success; (d) it shall not claim that alcohol has therapeutic qualities or that it is a stimulant, a sedative or a means of resolving personal conflicts; (e) it shall not encourage immoderate consumption of alcohol or present abstinence or moderation in a negative light; (f) it shall not place emphasis on high alcoholic content as being a positive quality of the beverages. Article 16 Television advertising shall not cause moral or physical detriment to minors, and shall therefore comply with the following criteria for their protection: (a) it shall not directly exhort minors to buy a product or a service by exploiting their inexperience or credulity; (b) it shall not directly encourage minors to persuade their parents or others to purchase the goods or services being advertised; (c) it shall not exploit the special trust minors place in parents, teachers or other persons; (d) it shall not unreasonably show minors in dangerous situations. Article 17 1. Sponsored television programmes shall meet the following requirements: (a) the content and scheduling of sponsored programmes may in no circumstances be influenced by the sponsor in such a way as to affect the responsibility and editorial independence of the broadcaster in respect of programmes; (b) they must be clearly identified as such by the name and/or logo of the sponsor at the beginning and/or the end of the programmes; (c) they must not encourage the purchase or rental of the products or services of the sponsor or a third party, in particular by making special promotional references to those products or services. 2. Television programmes may not be sponsored by natural or legal persons whose principal activity is the manufacture or sale of products, or the provision of services, the advertising of which is prohibited by Article 13 or 14. 3. News and current affairs programmes may not be sponsored. Article 18 1. The amount of advertising shall not exceed 15 % of the daily transmission time. However, this percentage may be increased to 20 % to include forms of advertisements such as direct offers to the public for the sale, purchase or rental of products or for the provision of services, provided the amount of spot advertising does not exceed 15 %. 2. The amount of spot advertising within a given one-hour period shall not exceed 20 %. 3. Without prejudice to the provisions of paragraph 1, forms of advertisements such as direct offers to the public for the sale, purchase or rental of products or for the provision of services shall not exceed one hour per day. Article 19 Member States may lay down stricter rules than those in Article 18 for programming time and the procedures for television broadcasting for television broadcasters under their jurisdiction, so as to reconcile demand for televised advertising with the public interest, taking account in particular of: (a) the role of television in providing information, education, culture and entertainment; (b) the protection of pluralism of information and of the media. Article 20 Without prejudice to Article 3, Member States may, with due regard for Community law, lay down conditions other than those laid down in Article 11 (2) to (5) and in Article 18 in respect of broadcasts intended solely for the national territory which may not be received, directly or indirectly, in one or more other Member States. Article 21 Member States shall, within the framework of their laws, ensure that in the case of television broadcasts that do not comply with the provisions of this chapter, appropriate measures are applied to secure compliance with these provisions. CHAPTER V Protection of minors Article 22 Member States shall take appropriate measures to ensure that television broadcasts by broadcasters under their jurisdiction do not include programmes which might seriously impair the physical, mental or moral development of minors, in particular those that involve pornography or gratuitous violence. This provision shall extend to other programmes which are likely to impair the physical, mental or moral development of minors, except where it is ensured, by selecting the time of the broadcast or by any technical measure, that minors in the area of transmission will not normally hear or see such broadcasts. Member States shall also ensure that broadcasts do not contain any incitement to hatred on grounds of race, sex, religion or nationality. CHAPTER VI Right of reply Article 23 1. Without prejudice to other provisions adopted by the Member States under civil, administrative or criminal law, any natural or legal person, regardless of nationality, whose legitimate interests, in particular reputation and good name, have been damaged by an assertion of incorrect facts in a television programme must have a right of reply or equivalent remedies. 2. A right of reply or equivalent remedies shall exist in relation to all broadcasters under the jurisdiction of a Member State. 3. Member States shall adopt the measures needed to establish the right of reply or the equivalent remedies and shall determine the procedure to be followed for the exercise thereof. In particular, they shall ensure that a sufficient time span is allowed and that the procedures are such that the right or equivalent remedies can be exercised appropriately by natural or legal persons resident or established in other Member States. 4. An application for exercise of the right of reply or the equivalent remedies may be rejected if such a reply is not justified according to the conditions laid down in paragraph 1, would involve a punishable act, would render the broadcaster liable to civil law proceedings or would transgress standards of public decency. 5. Provision shall be made for procedures whereby disputes as to the exercise of the right of reply or the equivalent remedies can be subject to judicial review. CHAPTER VII Final provisions Article 24 In fields which this Directive does not coordinate, it shall not affect the rights and obligations of Member States resulting from existing conventions dealing with telecommunications or broadcasting. Article 25 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 3 October 1991. They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the fields governed by this Directive. Article 26 Not later than the end of the fifth year after the date of adoption of this Directive and every two years thereafter, the Commission shall submit to the European Parliament, the Council, and the Economic and Social Committee a report on the application of this Directive and, if necessary, make further proposals to adapt it to developments in the field of television broadcasting. Article 27 This Directive is addressed to the Member States.

31989L0595

1989

Council Directive 89/595/EEC of 10 October 1989 amending Directive 77/452/EEC concerning the mutual recognition of diplomas, certificates and other evidence of the formal qualifications of nurses responsible for general care, including measures to facilitate the effective exercise of the right of establishment and freedom to provide services, and amending Directive 77/453/EEC concerning the coordination of provisions laid down by law, regulation or administrative action in respect of the activities of nurses responsible for general care Having regard to the Treaty establishing the European Economic Community, and in particular Articles 49, 57 (1) and the first and third sentences of paragraph 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), Whereas the second subparagraph of Article 1 (3) of Directive 77/453/EEC (4) sets out the principle that theoretical and technical training shall be coordinated and balanced with clinical training, although no specific ratio is laid down; whereas Article 1 (4) states that the Council, acting on a proposal from the Commission, shall decide whether these provisions should be retained or amended; Whereas, in the light of this review and given in particular the increased demands as regards the level of knowledge of nurses responsible for general care, it is appropriate to amend Article 1 (4) of Directive 77/453/EEC in such a way as to set the length of the theoretical instruction at at least one-third, and that of the clinical instruction at at least one-half, of the minimum length of the training referred to in Article 1 (2) (b) of that Directive; whereas that ratio makes it necessary to define more precisely theoretical instruction and clinical instruction; Whereas it is also necessary to specify, as in the case of similar provisions in other directives relating to the health professions, that the list of subjects in the Annex to Directive 77/453/EEC is not restrictive and to use as standard terms ´theoretical instruction' and ´clinical instruction' in Directive 77/453/EEC and in the headings in its Annex; whereas it is likewise necessary to align the wording of certain provisions of Directive 77/452/EEC (5), as last amended by Directive 89/594/EEC (6), with that of similar provisions of Council Directive 75/362/EEC of 16 June 1975 concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications in medicine, including measures to facilitate the effective exercise of the right of establishment and freedom to provide services (7), as last amended by Directive 89/594/EEC, Article 1 Directive 77/452/EEC is hereby amended as follows: 1. Article 6 (3) is replaced by: ´3. If the host Member State has detailed knowledge of a serious matter which has occurred, prior to the establishment of the person concerned in that State, outside its territory and which is likely to affect the taking up within its territory of the activity concerned, it may inform the Member State of origin or the Member State from which the foreign national comes. The Member State of origin or the Member State from which the foreign national comes shall verify the accuracy of the facts. Its authorities shall decide on the nature and extent of the investigation to be made and shall inform the host Member State of any consequential action which they take with regard to the certificates or documents they have issued. Member States shall ensure the confidentiality of the information made available.'; 2. Article 7 (2) is replaced by: ´2. If the host Member State has detailed knowledge of a serious matter which has occurred, prior to the establishment of the person concerned in that State, outside its territory and which is likely to affect the pursuit within its territory of the activity concerned, it may inform the Member State of origin or the Member State from which the foreign national comes. The Member State of origin or the Member State from which the foreign national comes shall verify the accuracy of the facts. Its authorities shall decide on the nature and extent of the investigation to be made and shall inform the host Member State of any consequential action which they take with regard to the information they have forwarded in accordance with paragraph 1.'; 3. the following Article is inserted: ´Article 10a Where a host Member State requires its own nationals wishing to take up or pursue one of the activities referred to in Article 1 to take an oath or make a solemn declaration and where the form of such an oath or declaration cannot be used by nationals of other Member States, the host Member State shall ensure that an appropriate and equivalent form of oath or declaration is offered to the persons concerned.'; 4. the following is inserted after the second subparagraph of Article 11 (1): ´For this purpose and in addition to the declaration provided for in paragraph 2 relating to the services to be provided, Member States may, so as to permit the implementation of the provisions relating to professional conduct in force in their territory, require either automatic temporary registration or pro forma membership of a professional organization or body or, as an alternative, registration, provided that such registration or membership does not delay or in any way complicate the provision of services or impose any additional costs on the person providing the services.'; 5. Article 14 is deleted. Article 2 Directive 77/453/EEC is hereby amended as follows: 1. paragraphs 2 (b), 3 and 4 of Article 1 are replaced by: ´2. (b) full-time training, of a specifically vocational nature, which must cover the subjects of the programme set out in the Annex to this Directive and comprise a three-year course or 4 600 hours of theoretical and clinical instruction. ´3. Member States shall ensure that the institution training nurses is responsible for the coordination of theoretical and clinical instruction throughout the training. (a) ´Theoretical instruction' shall be defined as: that part of nursing training whereby student nurses acquire the knowledge, understanding and professional skills needed to plan, provide and assess total nursing care. This teaching is provided in nursing schools and other teaching environments chosen by the training institution, and is given by a staff of nursing teachers and other competent persons. (b) ´Clinical instruction' shall be defined as: that part of nursing training whereby student nurses as part of a team and indirect contact with a healthy or sick individual and/or a community learn to plan, provide and assess the required total nursing care on the basis of their acquired knowledge and skills. The student nurse learns not only to be a member of the team, but to be a team leader organizing total nursing care, including health education for individuals and small groups in the health institutions or the community. This instruction takes place in hospitals and other health institutions and in the community, under the responsibility of teachers who are nurses and with the cooperation and assistance of other qualified nurses. Other qualified personnel may be involved in this teaching process. Student nurses shall participate in the activities of the departments concerned in so far as those activities contribute to their training, enabling them to learn to undertake the responsibilities inherent in nursing care. 4. The theoretical instruction referred to in part A of the Annex shall be balanced and coordinated with the clinical instruction referred to in part B of the Annex in such a way that the knowledge and experience listed in paragraph 1 of this Article may be acquired in an adequate manner. The length of the theoretical instruction shall amount to no less than one-third and that of the clinical instruction to no less than one-half of the minimum length of training referred to in paragraph 2 (b).'; 2. the Annex is amended as follows: (a) the introductory sentence is replaced by: ´The training programme leading to the award of a diploma, certificate or other evidence of formal qualifications as nurse responsible for general care shall consist of the two parts and at least the subjects listed below. Instruction in one or more of these subjects may be given as part of, or in association with, other courses.'; (b) the headings of parts A and B are amended as follows: - in the Spanish version, ´A. Enseñanza teórica y técnica' is replaced by ´A. Enseñanza teórica' and ´B. Enseñanzas de enfermería clínica' is replaced by ´B. Enseñanza clínica', - in the Danish version, ´A. Teoretisk og teknisk undervisning' is replaced by ´A. Teoretisk undervisning', - in the German version, ´A. Theoretischer und technischer Unterricht' is replaced by ´A. Theoretischer Unterricht' and ´B. Klinisch-praktische Krankenpflege-Ausbildung' is replaced by ´B. Klinische Unterweisung', - in the Greek version, ´A. Theoritiki kai praktiki didaskalia' is replaced by ´A. Theoritiki didaskalia' and ´B. Kliniki didaskalia toy nosokomoy' is replaced by ´B. Kliniki didaskalia', - in the English version, ´A. Theoretical and technical instruction' is replaced by ´A. Theoretical instruction', - in the French version, ´A. Enseignement théorique et technique' is replaced by ´A. Enseignement théorique' and ´B. Enseignement infirmier clinique' is replaced by ´B. Enseignement clinique', - in the Italian version, ´A. Insegnamento teorico e tecnico' is replaced by ´A. Insegnamento teorico' and ´B. Insegnamento infermieristico clinico' is replaced by ´B. Insegnamento clinico', - in the Dutch version, ´A. Theoretisch en technisch onderwijs' is replaced by ´A. Theoretisch onderwijs', - in the Portuguese version, ´A. Ensino teórico e técnico' is replaced by ´A. Ensino teórico' and ´B. Ensino clínico da enfermagem' is replaced by ´B. Ensino clínico'. Article 3 Training courses for nurses responsible for general care commenced before 13 October 1991 under the previous scheme in accordance with Article 1 of Directive 77/453/EEC may be concluded in accordance with that scheme. Article 4 Member States shall bring into force the measures necessary to comply with this Directive no later than 13 October 1991. They shall forthwith inform the Commission thereof. Article 5 This Directive is addressed to the Member States.

31989L0594

1989

Council Directive 89/594/EEC of 30 October 1989 amending Directives 75/362/EEC, 77/452/EEC, 78/686/EEC, 78/1026/EEC and 80/154/EEC relating to the mutual recognition of diplomas, certificates and other evidence of formal qualifications as doctors, nurses responsible for general care, dental practitioners, veterinary surgeons and midwives, together with Directives 75/363/EEC, 78/1027/EEC and 80/155/EEC concerning the coordination of provisions laid down by Law, Regulation or Administrative Action relating to the activities of doctors, veterinary surgeons and midwives Having regard to the Treaty establishing the European Economic Community, and in particular Articles 49, 57 (1) and (2), first and third sentences, 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), Whereas certain technical amendents should be made to Directives 75/362/EEC (4), 77/452/EEC (5), 78/686/ EEC (6), 78/1026/EEC (7) and 80/154/EEC (8), as last amended by the Act of Accession of Spain and Portugal, concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications as doctors, nurses responsible for general care, dental practitioners, veterinary surgeons and midwives, and to Council Directive 75/363/EEC (9), as last amended by Directive 82/76/EEC (10), and Directives 78/1027/EEC (11) and 80/155/EEC (12), concerning the coordination of provisions laid down by law, regulation or administrative action in respect of the activities of doctors, veterinary surgeons and midwives, respectively, in order to take account in particular of changes in the titles of diplomas, certificates and other evidence of formal qualifications in these professions or in the designation of certain medical specializations, as well as of the establishment of certain new medical specializations or the discontinuing of certain former specializations which have taken place in some Member States; Whereas it is necessary to protect at Community level the rights acquired by the holders of former qualifications which are no longer awarded as a result of the above changes which have taken place in the rules of the Member State which awarded the qualification to them and to supplement where necessary in this connection the said Directives by appropriate provisions; Whereas it is advisable to provide, for reasons of equity, for transitional measures for certain holders of diplomas, certificates or other evidence of formal qualifications as ¹ veterinary surgeon and midwife awarded by the Republic of Italy and the Kingdom of Spain respectively following training not complying fully with Directives 78/1027/EEC and 80/155/EEC, CHAPTER 1 Amendments relating to Directives 75/362/EEC and 75/363/EEC (mutual recognition of diplomas, certificates and other evidence of formal qualifications in medicine and coordination of the provisions laid down by law, regulation or administrative action relating to the activities of doctors) Article 1 Article 3 of Directive 75/362/EEC is hereby amended as follows: 1. under heading (a) ´in Germany': - point 2 is replaced by the following: ´2. the State examination certificate in medicine awarded by the competent authorities after 30 June 1988 and the certificate attesting to the practice of medicine during a period of practical training (´´Arzt im Praktikum'');', - point 2 becomes point 3, and ´those listed in point 1 above;' is replaced by ´those listed in points 1 and 2;' 2. (f) ´in Italy' is replaced by: ´(f) in Italy: ´´diploma di laurea in medicina e chirurgia'' (diploma of graduate in medicine and surgery) awarded by a university, accompanied by a ´´diploma di abilitazione all'esercizio della medicina e chirurgia'' (diploma conferring the right to practise medicine and surgery) awarded by the State Examining Commission;' 3. (j) ´in Greece' is replaced by: ´(j) in Greece: ´´Ptzxío Iatrikhw'' (degree in medicine) awarded by: - the faculty of medicine of a university, or - the faculty of health sciences, department of medicine, of a university;' 4. (k) ´in Spain' is replaced by: ´(k) in Spain: ´´Título di Licenciado en Medicina y Cirugía'' (university degree in medicine and surgery) awarded by the Ministery of Education and Science or the rector of a university;'. Article 2 Article 5 (2) of Directive 75/362/EEC is hereby amended as follows: 1. the text concerning Belgium is replaced by: ´in Belgium: ´´Le titre d'agrégation en qualité de médecin spécialiste/erkenningstitel van geneesheer specialist'' (formal evidence of having qualified as a medical specialist) issued by the Minister responsible for public health;' 2. under ´in France', the following indent is added: ´- ´´le diplôme d'études spécialisées de médecine délivré par les universités;'' (diploma of specialized studies in medicine awarded by a university);' 3. under ´in the Netherlands', the text is amended as follows: - the existing text becomes the first indent; - the following indent is added: ´"- Het door de Sociaal-Geneeskundigen Registratie-Comissie (SGRC) afgegeven getuigschrift van erkenning en inschrijving in het Register von Sociaal-Geneeskundigen'' (certificate of approval and registration issued by the board of registration of doctors of social medicine);' 4. the text concerning Greece is replaced by: ´in Greece: "Titlos Iatrikis eidikotitas chorigoymenos apo tis Nomarchies'' (certificate of medical specialization) awarded by the prefectures;'. Article 3 Article 5 (3) of Directive 75/362/EEC is hereby amended as follows: 1. under ´anaesthetics': - the subheading relating to France is replaced by: ´France: anesthésiologie-réanimation chirurgicale', - the subheading relating to the Netherlands is replaced by: ´Netherlands: anesthesiologie'; 2. under ´general surgery': - the subheading relating to Spain is replaced by: ´Spain: cirurgía general y del aparato digestivo'; 3. under ´ophthalmology': - the subheading relating to Belgium is replaced by: ´Belgium: opthalmologie-oftalmologie'; 4. under ´respiratory medicine': - the subheading relating to France is replaced by: ´France: pneumologie'; - the subheading relating to the Netherlands is replaced by: ´Netherlands: longziekten en tuberculose'; 5. under ´urology': - the subheading relating to France is replaced by: ´France: chirurgie urologique'; 6. under ´orthopaedics': - the subheading relating to France is replaced by: ´France: chirurgie orthopédique et traumatologie'; 7. the following headings are added: ´- pathological anatomy . ´- United Kingdom: Germany: Pathologie Belgium: anatomie pathologique/ pathologische anatomie Denmark: patologisk anatomi og histo- logi eller vaevsundersoegelse France: anatomie et cythologie pathologique Ireland: morbid anatomy and histopathology Italy: anatomia patologica Luxembourg: anatomie pathologique Netherlands: pathologische anatomie United Kingdom: morbid anatomy and histopathology Greece: pathologiki anatomiki Spain: anatomía patológica Portugal: anatomia patológica - neurology Germany: Neurologie Belgium: neurologie/neurologie Denmark: neuromedicin eller medicinske nervesygdomme France: neurologie Ireland: neurology Italy: neurologia Luxembourg: neurologie Netherlands: neurologie United Kingdom: neurology Greece: Nenrologia Spain: neurología Portugal: neurologia; - psychiatry Germany: Psychiatrie Belgium: psychiatrie/psychiatrie Denmark: psykiatri France: psychiatrie Ireland: psychiatry Italy: psichiatria Luxembourg: psychiatrie Netherlands: psychiatrie United Kingdom: psychiatry Greece: Psychiatriki Spain: psiquiatría Portugal: psiquiatria.' Article 4 Article 7 (2) of Directive 75/362/EEC is hereby amended as follows: 1. under ´biological haematology': - the following subheading is inserted: ´France: hématologie', - in all the language versions other than the French and the Portuguese, the subheading relating to Spain is deleted; 2. ´pathological anatomy' is deleted; 3. under ´plastic surgery': - the subheading relating to France is replaced by: ´France: chirurgie plastique, reconstructrice et esthéthique'; 4. under ´thoracic surgery': - the subheading relating to France is replaced by: ´France: chirurgie thoracique et cardio-vasculaire'; 5. under ´paediatric surgery': - the following subheading relating to France is inserted: ´France: chirurgie infantile'; 6. under ´vascular surgery': - in the Dutch language version the title of the heading is replaced by ´chirurgie van bloedvaten', - the following subheading is inserted: ´France: chirurgie vasculaire', - the subheading relating to Italy is replaced by: ´Italy: chirurgia vascolare'; 7. under ´cardiology', the subheading relating to France is replaced by: ´France: pathologie cardio-vasculaire'; 8. under ´gastro-enterology': - the subheading relating to France is replaced by: ´France: gastro-entérologie et hépatologie', - the subheading relating to Luxembourg is replaced by: ´Luxembourg: gastro-entérologie', - the subheading relating to the Netherlands is replaced by: ´Netherlands: gastro-enterologie', - the subheading relating to Greece is replaced by: ´Greece: gastrenteologia'; 9. under ´rheumatology': - the following subheading is inserted: ´Denmark: reumatologi'; 10. under ´endocrinology': - the following subheading is inserted: ´France: endocrinologie - maladies métaboliques', - the subheading relating to Luxembourg is replaced by: ´Luxembourg: endocrinologie, maladies du métabolisme et de la nutrition'; 11. under ´physiotherapy': - the subheading relating to Greece is replaced by: ´Greece: psysiki iatriki kai apokatastasi'; 12. ´neurology' and ´psychiatry' are deleted; 13. under ´neuro-psychiatry' the subheading relating to Greece is replaced by: ´Greece: nevrologia - psychiatriki'; 14. under ´dermato-venereology': - the subheading relating to France is replaced by: ´France: dermatologie et vénéréologie', - the subheading relating to the Netherlands is replaced by: ´Netherlands: dermatologie en venerologie'; 15. under ´radiology': - the subheading relating to France is replaced by: ´France: électro-radiologie'; 16. under ´diagnostic radiology': - the following subheading is inserted: ´Germany: Radiologische Diagnostik', - the subheading relating to France is replaced by: ´France: radiodiagnostic et imagerie médicale'; 17. under ´radiotherapy': - the following subheading is inserted: ´Germany: Strahlentherapie', - the subheading relating to France is replaced by: ´France: oncologie, option radiothérapie'; 18. under ´tropical medicine': - the subheading ´Belgium: médecine tropicale/ tropische geneeskunde' is deleted; 19. under ´child psychiatry': - the following subheading is inserted: ´Ireland: child and adolescent psychiatry'; 20. under ´geriatrics': - the following subheading is inserted: ´Netherlands: klinische geriatrie'; 21. under ´renal diseases': - the following subheading is inserted: ´France: néphrologie', - the following subheading is inserted: ´Luxembourg: néphrologie'; 22. under ´community medicine': - the following subheading is inserted: ´France: santé publique et médecine sociale'; 23. ´occupational medicine' is amended as follows: (a) the title, except in the English language version, is amended as follows: 23. (a) - Portuguese language - Danish language version: ´arbejdsmedicin' - German language version: ´Arbeitsmedizin' - Greek language version: ´iatriki tis ergasias' - Spanish language version: ´medicina del trabajo' - French language version: ´médecine du travail' - Italian language version: ´medicina del lavoro' - Dutch language version: ´arbeidsgeneeskunde' - Portuguese language version: ´medicina do trabalho'; (b) the following subheadings are inserted: 23. (b) ´Netherlands ´Germany: Arbeitsmedizin' ´Denmark: samfundsmedicin/ arbejdsmedecin' ´France: médecine du travail' ´Italy: medicina del lavoro'; ´Netherlands: arbeids- en bedrijfsgeneeskunde' ´Greece: iatriki tis ergasias' ´Portugal: medicina do trabalho'; 24. under ´allergology': - the subheading relating to Greece is replaced by: ´Greece: allergiologia'; 25. under ´gastro-enterological surgery': - the following subheading is inserted: ´France: chirurgie viscérale'; 26. the following headings are added: ´nuclear medicine: 26. ´United Kingdom: Germany: Nuklearmedizin Belgium: médecine nucléaire/ nucleaire geneeskunde France: médecine nucléaire Italy: medicina nucleare Netherlands: nucleaire geneeskunde United Kingdom: nuclear medicine Greece: pyriniki iatriki Spain: medicina nuclear Portugal: medicina nuclear; maxillo-facial surgery (basic medical training): France: chirurgie maxillo-faciale et stomatologie Italy: chirurgia maxillo-facciale Spain: cirugía oral y maxilofacial; dental, oral and maxillo-facial surgery (basic medical and dental training): Germany: Zahn-, Mund-, Kiefer- und Gesichtschirurgie Belgium: stomatologie/chirurgie orale et maxillo-faciale, stomatologie/orale en maxillo-faciale chirurgie Ireland: oral and maxillo-facial surgery United Kingdom: oral and maxillo-facial surgery.' Article 5 Article 9 (3) of Directive 75/362/EEC shall be replaced by: ´3. In the case of nationals of the Member States whose diplomas, certificates and other evidence of formal qualifications in medicine or in specialized medicine do not conform with the qualifications or designations set out in Articles 3, 5 and 7, each Member State shall recognize as being sufficient proof the diplomas, certificates and other evidence of formal qualifications awarded by those Member States, accompanied by a certificate issued by the competent authorities or bodies. The certificate shall state that these diplomas, certificates and other evidence of formal qualifications in medicine or in specialized medicine were awarded following training in accordance with the provisions of Directive 75/363/EEC, referred to, as appropriate, in Article 2, 4 or 6 of the present Directive, and are treated by the Member State which awarded them as the qualifications or designations set out, as appropriate, in Article 3, 5 or 7 of the present Directive.' Article 6 Article 2 of Directive 75/363/EEC is hereby amended as follows: - the following provision is added to paragraph 1 (a): ´the training leading to the award of the diploma, certificate or other evidence of specialization in dental, oral and maxillo-facial surgery (basic medical and dental training) also entails the sucessful completion of the training course as a dental practitioner referred to in Article 1 of Directive 78/687/EEC (13);', - the following footnote is added: ´(14) OJ No L 233, 24. 8. 1978, p. 10.', - the following provision is added to paragraph 2: ´Issue of the diploma, certificate or other evidence of specialization in dental, oral and maxillo-facial surgery (basic medical and dental training) is also subject to possession of one of the diplomas, certificates or other evidence of qualifications as a dental practitioner referred to in Article 1 of Directive 78/687/EEC.', - paragraph 3 is replaced by: ´3. Within the time limit laid down in Article 9, Member States shall designate the authorities or bodies competent to issue the diplomas, certificates and other evidence of formal qualifications referred to in paragraph 1.' Article 7 The following indents shall be added to Article 4 of Directive 75/363/EEC at the end of the heading ´Second group': ´- pathological anatomy - neurology - psychiatry'. Article 8 Article 5 of Directive 75/363/EEC is hereby amended as follows: 1. under ´First group': - in the Dutch language version ´chirurgie van hart- en bloedvaten' is replaced by ´chirurgie van bloedvaten', - the following entry is added: ´- maxillo-facial surgery (basic medical training)'; 2. under ´Second group': - ´neurology', ´psychiatry' and ´pathological anatomy' are deleted, - except in the English language version ´occupational medicine' is replaced by: 2. - - Portuguese language - Danish language version: ´arbejdsmedicin' - German language version: ´Arbeitsmedizin' - Greek language version: ´iatriki tis ergasias' - Spanish language version: ´medicina del trabajo' - French language version: ´médecine du travail' - Italian language version: ´medecina del lavoro' - Dutch language version: ´arbeidsgeneeskunde' - Portuguese language version: ´medicina do trabalho', - the following indents are added: ´- nuclear medicine, ´- dental, oral and maxillo-facial surgery (basic medical and dental training)'. Article 9 1. Those Member States which have repealed the provisions laid down by law, regulation or administrative action relating to the award of diplomas, certificates and other evidence of formal qualifications in neuro-psychiatry, radiology, thoracic surgery, vascular surgery, gastro-enterological surgery, biological haematology, physiotherapy or tropical medicine and have taken measures relating to acquired rights on behalf of their own nationals, shall recognize the right of nationals of the Member States to benefit from those same measures, provided their diplomas, certificates and other evidence of formal qualifications in neuropsychiatry, radiology, thoracic surgery, vascular surgery, gastro-enterological surgery, biological haematology, physiotherapy or tropical medicine fulfil the relevant conditions set out either in Article 9 (2) of Directive 75/362/EEC or in Articles 2, 3 and 5 of Directive 75/363/EEC and in so far as the said diplomas, certificates and other evidence of formal qualifications were awarded before the date on which the host Member State stopped awarding such diplomas, certificates and other evidence of formal qualification in the specialization concerned. 2. The dates on which the Member States concerned repealed the provisions laid down by law, regulation or administrative action in respect of the diplomas, certificates and other evidence of formal qualifications referred to in paragraph 1 are set out in the Annex. 3. Article 9 (4) of Directive 75/362/EEC and Article 15 of Directive 82/76/EEC are hereby deleted. CHAPTER 2 Amendments relating to Directive 77/452/EEC (mutual recognition of diplomas, certificates and other evidence of formal qualifications as nurse responsible for general care) Article 10 Article 1 (2) of Directive 77/452/EEC is hereby amended as follows: 1. under ´in the United Kingdom' the text is replaced by: ´State Registered Nurse or Registered General Nurse'; 2. under ´in Greece' the text is replaced by: ´Diplomatoychos i ptychioychos nosokomos, nosileftis i nosileftria'. Article 11 Article 3 of Directive 77/452/EEC is hereby amended as follows: 1. (f) ´in Italy' is replaced by: ´(f) in Italy: - the "diploma di infermiere professionale" awarded by State-recognized schools;' 2. (i) ´in the United Kingdom' is replaced by: ´(i) in the United Kingdom: - a statement of registration as a Registered General Nurse in Part I of the register maintained by the United Kingdom Central Council for Nursing, Midwifery and Health Visiting;' 3. (j) ´in Greece' is replaced by: ´(j) in Greece: - "To diploma Adelfis Nosokomas tis Anoteras Scholis Adelfon Nosokomon" (diploma of general nurse from the advanced school of general nursing), authenticated by the Ministry of Social Services or by the Ministry of Health and Social Welfare, or - "To ptychio Nosokomon toy Tmimatos Adelfon Nosokomon ton Paraiatrikon Scholon ton Kentron Anoteras Technikis kai Epangelmatikis Ekpaidefsis" (degree in nursing from the nursing sections of the paramedical schools at the advanced centres of technical and vocational training) awarded by the Ministry of Education and Religious Affairs, or - "To ptychio nosilefti i nosileftrias ton Technologikon Ekpaideftikon Idrymaton (TEI)" (degree in nursing from the technological training establishments) run by the Ministry of Education and Religious Affairs, or - "To ptychio tis Anotatis Nosileftikis tis Scholis Epangelmaton Ygeias, Tmima Nosileftikis toy Paneptistimioy Athinon" (degree in nursing from the faculty of health sciences, nursing section, University of Athens);' 4. (k) ´in Spain' is replaced by: ´(k) in Spain: "Título de Diplomado en Enfermería'' (university diploma in nursing) awarded by the Ministry for Education and Science or the rector of a university'. Article 12 Article 4 of Directive 77/452/EEC is hereby amended as follows: - the two existing paragraphs become paragraph 1 and is preceded by ´1.', - the following paragraph is added: ´2. In the case of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications as nurse responsible for general care do not conform with the qualifications or designations set out in Article 3, each Member State shall recognize as being sufficient proof the diplomas, certificates and other evidence of formal qualifications awarded by those Member States, accompanied by a certificate issued by the competent authorities or bodies. The certificate shall state that the diplomas, certificates and other evidence of formal qualifications as nurse responsible for general care were awarded following training in accordance with the provisions of Directive 77/453/EEC, referred to in Article 2 of the present Directive, and are treated by the Member State which awarded them as the qualifications or designations set out in Article 3 of the present Directive.' CHAPTER 3 Amendments relating to Directive 78/686/EEC (mutual recognition of diplomas, certificates and other formal evidence of qualifications as dental practitioner) Article 13 In Article 1 of Directive 78/686/EEC the text under the heading ´- in Italy' shall be replaced by the following: ´- in Italy: odontoiatra'. Article 14 In Article 5 of Directive 78/686/EEC the following subheading shall be added to paragraph ´1. Orthodontics': ´- in Greece: "Titlos tis Odootiatrikis eidikotitas tis Orthodontikis'' (title attesting to completion of specific orthodontic training) awarded by the competent authority recognized for that purpose.' Article 15 The following paragraph shall be inserted in Article 7 of Directive 78/686/EEC: ´3. In the case of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications in dentistry or in specialist dentistry (orthodontics and oral surgery) do not conform with the qualifications or designations set out in Articles 3 and 5, each Member State shall recognize as being sufficient proof the diplomas, certificates and other evidence of formal qualifications awarded by those Member States, accompanied by a certificate issued by the competent authorities or bodies. The certificate shall state that the diplomas, certificates and other evidence of formal qualifications as dental practitioner or as specialist dental practitioner (orthodontics and oral surgery) were awarded following training in accordance with the provisions of Directive 78/687/EEC, referred to, as appropriate, in Article 2 or 4 of this Directive, and are treated by the Member State which awarded them as the qualifications or designations set out, as appropriate, in Article 3 or 5 of this Directive.' CHAPTER 4 Amendments relating to Directives 78/1026/EEC and 78/1027/EEC (mutual recognition of diplomas, certificates and other evidence of formal qualifications as veterinary surgeon and coordination of provisions laid down by law, regulation or administrative action in respect of the activities of veterinary surgeons) Article 16 The second subparagraph of Article 2 of Directive 78/1026/EEC is hereby replaced by the following: ´Where a diploma, certificate or other evidence of formal qualifications as listed in Article 3 was awarded before the implementation of this Directive, or was awarded after that date but following training commenced before that date, it shall be accompanied by a certificate from the competent authorities of the issuing Member State stating that it complies with Article 1 of Directive 78/1027/EEC.' Article 17 Article 3 of Directive 78/1026/EEC is hereby amended as follows: 1. (j) ´in Greece' is replaced by: ´(j) in Greece: "Ptychio ktiniatrikis" (diploma of veterinary surgeon) from the faculty of geotechnical sciences of the Aristotle University of Saloniki or the School of veterinary medicine of the Aristotle University of Saloniki;' 2. (k) ´in Spain' is replaced by: ´(k) in Spain: "Título de Licenciado en Veterinaría" (university degree in veterinary medicine) awarded by the Ministry of Education and Science or by the rector of a university;'. Article 18 Article 4 of Directive 78/1026/EEC is hereby replaced by the following: ´Article 4 1. In the case of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications do not satisfy all the minimum training requirements laid down in Article 1 of Directive 78/1027/EEC, each Member State shall recognize as being sufficient proof the diplomas, certificates and other evidence of formal qualifications in veterinary medicine awarded by those Member States before the implementation of Directive 78/1027/EEC or awarded after that date but following training commenced before that date, accompanied by a certificate stating that those nationals have effectively and lawfully been engaged in the activities in question for at least three consecutive years during the five years prior to the date of isse of the certificate. 2. In the case of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications as veterinary surgeon do not conform with the qualifications or designations set out in Article 3, each Member State shall recognize as being sufficient proof the diplomas, certificates and other evidence of formal qualifications awarded by those Member States, accompanied by a certificate issued by the competent authorities or bodies. The certificate shall certify that the diplomas, certificates and other evidence of formal qualifications as veterinary surgeon were awarded following training in accordance with the provisions of Directive 78/1027/EEC, referred to in Article 2 of this Directive, and are treated by the Member State which awarded them as the qualifications or designations set out in Article 3 of this Directive.' Article 19 The following paragraph is hereby added to Article 1 of Directive 78/1027/EEC: ´5. As a transitional measure and notwithstanding paragraph 2, Italy, whose provisions laid down by law, regulation or administrative action provided for a training programme which did not comply fully with that set out in the Annex when Directive 78/1026/EEC and this Directive took effect, may continue to apply those provisions to persons who commenced their veterinary training not later than 31 December 1984. Each host Member State shall be authorized to require of holders of diplomas, certificates or other evidence of formal qualifications as veterinary surgeon awarded by Italy following training commenced before 1 January 1985 that their diplomas, certificates and other evidence of formal qualifications be accompanied by a certificate stating that they have effectively and lawfully been engaged in the activities of veterinary surgeon for at least three consecutive years during the five years prior to the date of the issue of the certificate, unless the said diploma, certificate or other evidence of formal qualifications is accompanied by a certificate issued by the competent Italian authorities stating that it attests to training in full compliance with this Article and with the Annex.' Article 20 In the Annex to Directive 78/1027/EEC in the Greek language version under ´B. Specific subjects' the first indent of ´Group 2: Clinical sciences' ´Cheiroyrgiki' is hereby replaced by ´Maieftiki'. CHAPTER 5 Amendments relating to Directives 80/154/EEC and 80/155/EEC (mutual recognition of diplomas, certificates and other evidence of formal qualificactions as midwife and coordination of the provisions laid down by law, regulation or administrative action in respect of the activities and exercise of the profession of midwife) Article 21 Article 1 of Directive 80/154/EEC is hereby amended as follows: 1. under ´in the Federal Republic of Germany' the text is replacing by: ´Hebamme' or ´Entbindungspfleger'; 2. under ´in Greece' in text is replaced by: ´Maia' or ´Maieftis'. Article 22 Article 3 of Directive 80/154/EEC is hereby amended as follows: 1. under (a) ´in the Federal Republic of Germany' the first indent is replaced by: ´- the "Zeugnis ueber die staatliche Pruefung fuer Hebammen und Entbindungspfleger", award by the State examining board'; 2. under (h) ´in the Netherlands' in all the language versions other than the Dutch language version, ´vroedvrouwdiploma' is replaced by ´diploma van verloskundige'; 3. (i) ´in the United Kingdom' is replaced by: ´(i) in the United Kingdom: - a statement of registration as a midwife in Part 10 of the Register maintained by the United Kingdom Central Council for Nursing, Midwifery and Health Visiting'; 4. (j) ´in Greece' is replaced by: ´(j) in Greece: - the ´´Ptzxío Maíaw h Maiezth'' authenticated by the Ministry of Health and Welfare, - the ´´Ptzxío Anvtéraw Sxolhw Stelexvn Zgeíaw kai Koinvnikhw Prónoiaw, Tmhmatow Maieztikhw'' awarded by the faculty of health and social welfare workers, obstetrics section, of the advanced technical and vocational education centres or by the technological training establishments run by the Ministry of Education and Religious Affairs'; 5. (k) ´in Spain' is replaced by: ´(k) in Spain: the diploma of ´´matrona'' or ´´asistente obstétrico (matrona)'' or ´´enfermería obstétrica- ginecológica'', awarded by the Ministry of Education and Science;'. Article 23 The following new paragraph 3 is hereby added to Article 5 of Directive 80/154/EEC: ´3. Without prejudice to Article 4, in the case of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications as midwife do not conform with the qualifications or designations set out in Article 3, each Member State shall recognize as being sufficient proof diplomas, certificates and other evidence of formal qualifications awarded by those Member States accompanied by a certificate issued by the competent authorities or bodies. The certificate shall state that the diplomas, certificates and other evidence of formal qualifications as midwife were awarded following training in accordance with the provisions of Directive 80/155/EEC, referred to in Article 2 of this Directive and are treated by the Member State which awarded them as the qualifications or designations set out in Article 3 of this Directive.' Article 24 The following paragraphs 5 and 6 are hereby added to Article 1 of Directive 80/155/EEC: ´5. Nothing in this Directive shall prejudice any facility which may be granted in accordance with their own rules by Member States in respect of their own territory to authorize holders of diplomas, certificates and other evidence of formal qualifications which have not been obtained in a Member State to take up and pursue the activities of midwife. 6. As a transitional measure and notwithstanding paragraphs 1 and 4, Spain, whose provisions laid down by law, regulation or administrative action provided for training which did not comply with this Directive when Directive 80/154/EEC and this Directive took effect, may continue to apply those provisions to persons who commenced their specific midwifery training not later than 31 December 1985. Each host Member State shall be authorized to require of holders of diplomas, certificates or other evidence of formal qualifications as midwife awarded by Spain following specific training commenced before 1 January 1986 that their diplomas, certificates and other evidence of formal qualifications be accompanied by a certificate stating that they have effectively and lawfully been engaged in the activities of midwife for at least three consecutive years during the five years prior to the date of the issue of the certificate, unless the said diploma, certificate or other evidence of formal qualifications is accompanied by a certificate issued by the competent Spanish authorities stating that it attests to training in full compliance with this Article and with the Annex.' Article 25 In Article 4 (6) of Directive 80/155/EEC in the Spanish language version the text shall be replaced by the following: ´6. llevar a cabo el parto normal cuando se trate de una presentación de vértice, incluyendo, si es necesario, la episiotomía, y, en caso de urgencia, realizar el parto en presentación de nalgas.' Article 26 In Article 8 of Directive 80/155/EEC in the German language version the text shall be replaced by the following: ´Article 8 Spaetestens sechs Jahre nach Bekanntgabe dieser Richtlinie beschliesst der Rat auf Vorschlag der Kommission und nach Stellungnahme des Beratenden Ausschusses, ob die Ausnahme nach Teil B Nummer 3 des Anhangs geaendert oder aufgehoben werden soll.' Article 27 Part B of the Annex to Directive 80/155/EEC shall be replaced by the following: ´B. PRACTICAL AND CLINICAL TRAINING This training is to be dispensed under appropriate supervision: 1. Advising of pregnant women, involving at least 100 pre-natal examinations. 2. Supervision and care of at least 40 women in labour. 3. The student should personally carry out at least 40 deliveries; where this number cannot be reached owing to the lack of available women in labour, it may be reduced to a minimum of 30, provided that the student participates actively in 20 further deliveries. 4. Active participation with breech deliveries. Where this is not possible because of lack of breech deliveries practice may be in a simulated situation. 5. Performance of episiotomy and initiation into suturing. Initiation shall include theoretical instruction and clinical practice. The practice of suturing includes suturing of the wound following an episiotomy and a simple perineal laceration. This may be in a simulated situation if absolutely necessary. 6. Supervision and care of 40 women at risk in pregnancy, or labour or post-natal period. 7. Supervision and care (including examination) of at least 100 post-natal women and healthy new-born infants. 8. Observation and care of the new-born requiring special care including those born pre-term, post-term, underweight or ill. 9. Care of women with pathological conditions in the fields of gynaecology and obstetrics. 10. Initiation into care in the field of medicine and surgery. Initiation shall include theoretical instruction and clinical practice.' CHAPTER 6 Final provisions Article 28 Member States shall take the necessary measures to comply with this Directive by 8 May 1991. They shall forthwith inform the Commission thereof. Article 29 This Directive is addressed to the Member States.

31989L0592

1989

Council Directive 89/592/EEC of 13 November 1989 coordinating regulations on insider dealing 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 100a (1) of the Treaty states that the Council shall adopt the measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market; Whereas the secondary market in transferable securities plays an important role in the financing of economic agents; Whereas, for that market to be able to play its role effectively, every measure should be taken to ensure that market operates smoothly; Whereas the smooth operation of that market depends to a large extent on the confidence it inspires in investors; Whereas the factors on which such confidence depends include the assurance afforded to investors that they are placed on an equal footing and that they will be protected against the improper use of inside information; Whereas, by benefiting certain investors as compared with others, insider dealing is likely to undermine that confidence and may therefore prejudice the smooth operation of the market; Whereas the necessary measures should therefore be taken to combat insider dealing; Whereas in some Member States there are no rules or regulations prohibiting insider dealing and whereas the rules or regulations that do exist differ considerably from one Member State to another; Whereas it is therefore advisable to adopt coordinated rules at a Community level in this field; Whereas such coordinated rules also have the advantage of making it possible, through cooperation by the competent authorities, to combat transfrontier insider dealing more effectively; Whereas, since the acquisition or disposal of transferable securities necessarily involves a prior decision to acquire or to dispose taken by the person who undertakes one or other of these operations, the carrying-out of this acquisition or disposal does not constitute in itself the use of inside information; Whereas insider dealing involves taking advantage of inside information; whereas the mere fact that market-makers, bodies authorized to act as contrepartie, or stockbrokers with inside information confine themselves, in the first two cases, to pursuing their normal business of buying or selling securities or, in the last, to carrying out an order should not in itself be deemed to constitute use of such inside information; whereas likewise the fact of carrying out transactions with the aim of stabilizing the price of new issues or secondary offers of transferable securities should not in itself be deemed to constitute use of inside information; Whereas estimates developed from publicly available data cannot be regarded as inside information and whereas, therefore, any transaction carried out on the basis of such estimates does not constitute insider dealing within the meaning of this Directive; Whereas communication of inside information to an authority, in order to enable it to ensure that the provisions of this Directive or other provisions in force are respected, obviously cannot be covered by the prohibitions laid down by this Directive, Article 1 For the purposes of this Directive: 1. 'inside information' shall mean information which has not been made public of a precise nature relating to one or several issuers of transferable securities or to one or several transferable securities, which, if it were made public, would be likely to have a significant effect on the price of the transferable security or securities in question; 2. 'transferable securities' shall mean: (a) shares and debt securities, as well as securities equivalent to shares and debt securities; (b) contracts or rights to subscribe for, acquire or dispose of securities referred to in (a); (c) futures contracts, options and financial futures in respect of securities referred to in (a); (d) index contracts in respect of securities referred to in (a), when admitted to trading on a market which is regulated and supervised by authorities recognized by public bodies, operates regularly and is accessible directly or indirectly to the public. Article 2 1. Each Member State shall prohibit any person who: - by virtue of his membership of the administrative, management or supervisory bodies of the issuer, - by virtue of his holding in the capital of the issuer, or - because he has access to such information by virtue of the exercise of his employment, profession or duties, possesses inside information from taking advantage of that information with full knowledge of the facts by acquiring or disposing of for his own account or for the account of a third party, either directly or indirectly, transferable securities of the issuer or issuers to which that information relates. 2. Where the person referred to in paragraph 1 is a company or other type of legal person, the prohibition laid down in that paragraph shall apply to the natural persons who take part in the decision to carry out the transaction for the account of the legal person concerned. 3. The prohibition laid down in paragraph 1 shall apply to any acquisition or disposal of transferable securities effected through a professional intermediary. Each Member State may provide that this prohibition shall not apply to acquisitions or disposals of transferable securities effected without the involvement of a professional intermediary outside a market as defined in Article 1 (2) in fine. 4. This Directive shall not apply to transactions carried out in pursuit of monetary, exchange-rate or public debt-management policies by a sovereign State, by its central bank or any other body designated to that effect by the State, or by any person acting on their behalf. Member States may extend this exemption to their federated States or similar local authorities in respect of the management of their public debt. Article 3 Each Member State shall prohibit any person subject to the prohibition laid down in Article 2 who possesses inside information from: (a) disclosing that inside information to any third party unless such disclosure is made in the normal course of the exercise of his employment, profession or duties; (b) recommending or procuring a third party, on the basis of that inside information, to acquire or dispose of transferable securities admitted to trading on its securities markets as referred to in Article 1 (2) in fine. Article 4 Each Member State shall also impose the prohibition provided for in Article 2 on any person other than those referred to in that Article who with full knowledge of the facts possesses inside information, the direct or indirect source of which could not be other than a person referred to in Article 2. Article 5 Each Member State shall apply the prohibitions provided for in Articles 2, 3 and 4, at least to actions undertaken within its territory to the extent that the transferable securities concerned are admitted to trading on a market of a Member State. In any event, each Member State shall regard a transaction as carried out within its territory if it is carried out on a market, as defined in Article 1 (2) in fine, situated or operating within that territory. Article 6 Each Member State may adopt provisions more stringent than those laid down by this Directive or additional provisions, provided that such provisions are applied generally. In particular it may extend the scope of the prohibition laid down in Article 2 and impose on persons referred to in Article 4 the prohibitions laid down in Article 3. Article 7 The provisions of Schedule C.5 (a) of the Annex to Directive 79/279/EEC (1) shall also apply to companies and undertakings the transferable securities of which, whatever their nature, are admitted to trading on a market as referred to in Article 1 (2) in fine of this Directive. Article 8 1. Each Member State shall designate the administrative authority or authorities competent, if necessary in collaboration with other authorities to ensure that the provisions adopted pursuant to this Directive are applied. It shall so inform the Commission which shall transmit that information to all Member States. 2. The competent authorities must be given all supervisory and investigatory powers that are necessary for the exercise of their functions, where appropriate in collaboration with other authorities. Article 9 Each Member State shall provide that all persons employed or formerly employed by the competent authorities referredc to in Article 8 shall be bound by professional secrecy. Information covered by professional secrecy may not be divulged to any person or authority except by virtue of provisions laid down by law. Article 10 1. The competent authorities in the Member States shall cooperate with each other whenever necessary for the purpose of carrying out their duties, making use of the powers mentioned in Article 8 (2). To this end, and notwithstanding Article 9, they shall exchange any information required for that purpose, including information relating to actions prohibited, under the options given to Member States by Article 5 and by the second sentence of Article 6, only by the Member State requesting cooperation. Information thus exchanged shall be covered by the obligation of professional secrecy to which the persons employed or formerly employed by the competent authorities receiving the information are subject. 2. The competent authorities may refuse to act on a request for information: (a) where communication of the information might adversely affect the sovereignty, security or public policy of the State addressed; (b) where judicial proceedings have already been initiated in respect of the same actions and against the same persons before the authorities of the State addressed or where final judgment has already been passed on such persons for the same actions by the competent authorities of the State addressed. 3. Without prejudice to the obligations to which they are subject in judicial proceedings under criminal law, the authorities which receive information pursuant to paragraph 1 may use it only for the exercise of their functions within the meaning of Article 8 (1) and in the context of administrative or judicial proceedings specifically relating to the exercise of those functions. However, where the competent authority communicating information consents thereto, the authority receiving the information may use it for other purposes or forward it to other States' competent authorities. Article 11 The Community may, in conformity with the Treaty, conclude agreements with non-member countries on the matters governed by this Directive. Article 12 The Contact Committee set up by Article 20 of Directive 79/279/EEC shall also have as its function: (a) to permit regular consultation on any practical problems which arise from the application of this Directive and on which exchanges of view are deemed useful; (b) to advise the Commission, if necessary, on any additions or amendments to be made to this Directive. Article 13 Each Member State shall determine the penalties to be applied for infringement of the measures taken pursuant to this Directive. The penalties shall be sufficient to promote compliance with those measures. Article 14 1. Member States shall take the measures necessary to comply with this Directive before 1 June 1992. They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive. Article 15 This Directive is addressed to the Member States.

31989L0604

1989

Council Directive 89/604/EEC of 23 November 1989 amending Directive 83/183/EEC on tax exemptions applicable to permanent imports from a Member State of the personal property of individuals 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, when it adopted Directive 83/183/EEC (4), the Council undertook to adopt unanimously, on a proposal from the Commission, provisions permitting a substantial relaxation and even the removal of the formalities relating to the grant of tax exemptions applicable to permanent imports from a Member State of the personal property of individuals; whereas the ad hoc Committee on a People's Europe, in its first report, endorsed by the Brussels European Council of 29 and 30 March 1985, invited the Commission to present such a proposal; Whereas it is necessary to facilitate the free movement of persons within the Community as far as possible; Whereas, pending the abolition of tax frontiers required to achieve a true internal market, it is necessary to harmonize and relax certain formalities necessary for the grant of the import exemption provided for in Directive 83/183/EEC, particularly as regards the drawing-up of an inventory of the property and proof of the existence of the normal residence; whereas it is necessary to ease the existing rules relating to the period of use of imported property and to the quantitative limits on certain items, Article 1 Directive 83/183/EEC is hereby amended as follows: 1. Article 2 (2) (b) shall be replaced by the following: '(b) of which the person concerned has had the actual use before the change of residence is effected or the secondary residence established. In the case of motor-driven vehicles (including their trailers), caravans, mobile homes, pleasure boats and private aircraft, Member States may require that the person concerned should have had the use of them for a period of at least six months before the change of residence. For the goods referred to in the second sentence of (a), Member States may require: - in the case of motor-driven vehicles (including their trailers), caravans, mobile homes, pleasure boats and private aircraft, that the person concerned should have had the use of them for a period of at least 12 months, - in the case of other goods, that the person concerned should have had the use of them for a period of at least six months, before the change of residence.' 2. Article 4 shall be reworded as follows: 'The motor-driven vehicles (including their trailers), caravans, mobile homes, pleasure boats and private aircraft imported shall not be disposed of, hired out or lent during the period of 12 months following their importation free of duty, except in circumstances duly justified to the satisfaction of the competent authorities of the Member State of importation.' 3. Article 5 (1) shall be replaced by the following: '1. Member States may impose limits on the duty-free importation of goods listed in Article 4 (1) of Directive 69/220/EEC (1), as last amended by Directive 89/220/EEC (2). However, those limits may not be less than four times the quantities shown in column II of the said Article, except in the case of tobacco products, the duty-free importation of which may be limited to the quantities shown in the said column. (1) OJ No L 133, 4. 6. 1969, p. 6 (2) OJ No L 92, 5. 4. 1989, p. 15.' 4. In Article 7: (a) paragraph 1 shall become subparagraph 1 (a): (b) in paragraph 1 the following subparagraph shall be added: '(b) The grant of the exemption shall, without prejudice to any Community transit procedure which may apply, be subject to the drawing-up of an inventory of goods on plain paper accompanied, if the State so requires, by a declaration, the model for and content of which shall be defined in accordance with the procedure laid down in Article 17 (2) and (3) of Regulation (EEC) No 678/85 (1). No reference to value may be demanded on the inventory of goods. (1) OJ No L 274, 15. 10. 1985, p. 1.' (c) the following shall be added to paragraph 2: 'Where, in accordance with Article 3, the property is imported in a number of operations within the period referred to above, only on the occasion of their first importation may Member States require the submission of a full inventory to which reference may also be made in the event of subsequent removals by other customs offices. Such inventory may be supplemented subject to the agreement of the competent authorities of the Member State of importation.' 5. In Article 8 (2): (a) the words 'for a period of at least 12 months' at the end of the first subparagraph shall be replaced by 'before establishment of the secondary residence'; (b) the third subparagraph shall be deleted. 6. In Article 9: (a) the beginning of paragraph 1 shall be replaced by the following: '1. Without prejudice to Articles 2 to 5, any person shall on marrying be entitled to exemption from the taxes referred to in Article 1 when importing into the Member State to which he intends to transfer his normal residence personal property which he acquired or of which he had the use, provided that:' (b) paragraph 2 shall be replaced by the following: '2. Exemption shall also be granted in respect of presents customarily given on the occasion of a marriage which are received by a person fulfilling the conditions laid down in paragraph 1 from persons having their normal place of residence in a Member State other than the Member State of import. The exemption shall apply to presents of a unit value of not more than ECU 350 provided that the value of each exempt present does not exceed ECU 1 400.' 7. In Article 11: (a) in paragraph 1, the words 'Until the entry into force of the Community tax rules adopted pursuant to Article 14 (2) of Directive 77/388/EEC' shall be deleted; (b) in paragraph 2, the reference to 'Article 2 (2)' shall be replaced by 'Article 2 (2) (a)'. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1990. They shall forthwith inform the Commission thereof. 2. Member States shall inform the Commission of the provisions which they adopt to implement this Directive. Article 3 This Directive is addressed to the Member States.

31989L0617

1989

Council Directive 89/617/EEC of 27 November 1989 amending Directive 80/181/EEC on the approximation of the laws of the Member States relating to units of measurement 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 80/181/EEC (4), as amended by Directive 85/1/EEC (5), provides for a definitive date to be fixed for the use of the legal imperial units of measurement listed in Chapter III of the Annex thereto; whereas, for some imperial units and for specific uses, it has appeared necessary to allow the Member States concerned to fix the appropriate date until which those units are legal units of measurement; Whereas Article 3 (5) of Directive 80/181/EEC allows new final dates to be set for the use of supplementary indications, Article 1 Directive 80/181/EEC is hereby amended as follows: 1. In Article 1, points (b) and (c) shall be replaced by the following: '(b) those listed in Chapter II of the Annex only in those Member States where they were authorized on 21 April 1973 and until a date to be fixed by those States; (c) those listed in Chapter III of the Annex only in those Member States where they were authorized on 21 April 1973 and until a date to be fixed by those States. This date may not be later than 31 December 1994; (d) those listed in Chapter IV of the Annex only in those Member States where they were authorized on 21 April 1973 and until a date to be fixed by those States. This date may not be later than 31 December 1999.' 2. In Article 3: - in paragraph 2, '31 December 1989' shall be replaced by '31 December 1999'; - paragraph 5 shall be deleted. 3. In Article 5, '1 March 1974' shall be replaced by '15 May 1983'. 4. In Article 6 the second subparagraph shall be deleted. 5. The Annex shall be amended as follows: (1) OJ No C 31, 7. 2. 1989, p. 7. (2) OJ No C 120, 16. 5. 1989, p. 73; OJ No C 291, 20. 11. 1989. (3) OJ No C 159, 26. 6. 1989, p. 3. (4) OJ No L 39, 15. 2. 1980, p. 40. (5) OJ No L 2, 3. 1. 1985, p. 11. (a) Chapter II shall be replaced by the following: 'CHAPTER II LEGAL UNITS OF MEASUREMENT REFERRED TO IN ARTICLE 1 (b), PERMITTED FOR SPECIFIC USES ONLY 1.2,5 // // // Field of application // Unit 1.2.3.4 // // Name // Approximate value // Symbol // // // // 1.2.3.4.5 // Road traffic signs, distance and speed measurement // mile yard foot inch // 1 mile = 1 yd = 1 ft = 1 in = // 1 609 m 0,9144 m 0,3048 m 2,54 × 10-2m // mile yd ft in // Dispense of draught beer and cider; milk in returnable containers // pint // 1 pt = // 0,5683 × 10-3m3 // pt // Land registration // acre // 1 ac = // 4 047 m2 // ac // Transaction in precious metals // troy ounce // 1 oz tr = // 31,10 × 10-3 kg // oz tr // // // // // Until the date to be fixed under Article 1 (b), the units listed in this Chapter may be combined with each other or whith those in Chapter I to form compound units.' (b) the unit 'fathom' shall be deleted from Chapter III. (c) The following Chapter shall be added: CHAPTER IV LEGAL UNITS OF MEASUREMENT REFERRED TO IN ARTICLE I (d), PERMITTED IN SPECIALIZED FIELDS ONLY 1.2,5 // // // Field of application // Unit 1.2.3.4 // // Name // Approximate value // Symbol // // // // 1.2.3.4.5 // Marine navigation // fathom // 1 fm = // 1,829 m // fm // Beer, cider, waters, lemonades and fruit juices in returnable containers // pint fluid ounce // 1 pt = 1 fl oz = // 0,5683 × 10-3m3 28,41 × 10-6m3 // pt fl. oz // Spirit drinks // gill // 1 gill = // 0,142 × 10-3m3 // gill // Goods sold loose in bulk // ounce (avoir dupois) pound // 1 oz = 1 lb= // 28,35 × 10-3 kg 0,4536 kg // oz lb // Gas supply // therm // 1 therm = // 105,506 × 106J // therm // // // // // Until the date to be fixed under Article 1 (d), the units listed in this Chapter may be combined with each other or with those in Chapter I to form compound units.' Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within 24 months of its notification at the latest (1). The shall forthwith inform the Commission thereof. Article 3 Notwithstanding Directive 80/181/EEC, Member States shall, after 31 December 1989, authorize or continue to permit the use of the supplementary indications referred to in Article 3 of that Directive. Article 4 This Directive is addressed to the Member States.

31989L0654

1989

COUNCIL DIRECTIVE 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) (89/654/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 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 the workplace; 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 the arrangement of the place of work; Whereas compliance with the minimum requirements designed to guarantee a better standard of safety and health at work is essential to ensure the safety and health of workers; 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 (6); whereas the provisions of the latter are therefore fully applicable to the workplace without prejudice to more stringent and/or specific provisions contained in the present Directive; Whereas this Directive is a practical contribution towards creating the social dimension of the internal market; Whereas, pursuant to Decision 74/325/EEC (7), 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, SECTION I GENERAL PROVISIONS Article 1 Subject 1. This Directive, which is the first individual directive within the meaning of Article 16 (1) of Directive 89/391/EEC, lays down minimum requirements for safety and health at the workplace, as defined in Article 2. 2. This Directive shall not apply to: (a) means of transport used outside the undertaking and /or the establishment, or workplaces inside means of transport; (b) temporary or mobile work sites; (c) extractive industries; (d) fishing boats; (e) fields, woods and other land forming part of an agricultural or forestry undertaking but situated away from the undertaking's buildings. 3. The provisions of Directive 89/391 /EEC are fully applicable to the whole scope referred to in paragraph 1, without prejudice to more restrictive and/or specific provisions contained in this Directive. Article 2 Definition For the purposes of this Directive, ‘workplace’ means the place intended to house workstations on the premises of the undertaking and/or establishment and any other place within the area of the undertaking and/or establishment to which the worker has access in the course of his employment. SECTION II EMPLOYERS' OBLIGATIONS Article 3 Workplaces used for the first time Workplaces used for the first time after 31 December 1992 must satisfy the minimum safety and health requirements laid down in Annex I. Article 4 Workplaces already in use Workplaces already in use before 1 January 1993 must satisfy the minimum safety and health requirements laid -down in Annex II at the latest three years after that date. However, as regards the Portuguese Republic, workplaces used before 1 January 1993 must satisfy, at the latest four years after that date, the minimum safety and health requirements appearing in Annex II. Article 5 Modifications to workplaces When workplaces undergo modifications, extensions and/or conversions after 31 December 1992, the employer shall take the measures necessary to ensure that those modifications, extensions and/or conversions are in compliance with the corresponding minimum requirements laid down in Annex I. Article 6 General requirements To safeguard the safety and health of workers, the employer shall see to it that: — traffic routes to emergency exits and the exits themselves are kept clear at all times, — technical maintenance of the workplace and of the equipment and devices, and in particular those referred to in Annexes I and II, is carried out and any faults found which are liable to affect the safety and health of workers are rectified as quickly as possible, — the workplace and the equipment and devices, and in particular those referred to in Annex I, point 6, and Annex II, point 6, are regularly cleaned to an adequate level of hygiene, — safety equipment and devices intended to prevent or eliminate hazards, and in particular those referred to in Annexes I and II, are regularly maintained and checked. Article 7 Information of workers 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 the workplace. Article 8 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, including the Annexes thereto. SECTION III MISCELLANEOUS PROVISIONS Article 9 Amendments to the Annexes Strictly technical amendments to the Annexes as a result of: — the adoption of Directives on technical harmonization and standardization of the design, manufacture or construction of parts of workplaces, and/or — technical progress, changes in international regulations or specifications and knowledge with regard to workplaces, shall be adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC. Article 10 Final provisions 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 forthwith inform the Commission thereof. However, the date applicable for the Hellenic Republic shall be 31 December 1994. 2. 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. 3. 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 employers and workers. The Commission shall inform the European Parliament, the Council, the Economic and Social Committee and the Advisory Council on Safety, Hygiene and Health Protection at Work. 4. 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 to 3. Article 11 This Directive is addressed to the Member States.

31989L0656

1989

COUNCIL DIRECTIVE 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 within the meaning of Article 16 (1) of Directive 89/391/EEC) (89/656/EEC) Having regard to the Treaty establishing the European Economic Community and in particular Article 118a thereof, Having regard to the Commission proposal (1), submitted 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 Article 118a of the Treaty provides that the Council shall adopt, by means of directives, minimum requirements designed to encourage improvements, especially in the working environment, to guarantee greater protection of the health and safety of workers; Whereas, under the said Article, such directives shall 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 the adoption of a directive on the use of personal protective equipment at work; Whereas the Council, in its resolution of 21 December 1987 concerning safety, hygiene and health at work (5), noted the Commission's intention of submitting to it in the near future minimum requirements concerning the organization of the safety and health of workers at work; Whereas compliance with the minimum requirements designed to guarantee greater health and safety for the user of personal protective equipment is essential to ensure the safety and health of workers; 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 (6); whereas, consequently, the provisions of the said Directive apply fully to the use by workers of personal protective equipment at the workplace, 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; Whereas collective means of protection shall be accorded priority over individual protective equipment; whereas the employer shall be required to provide safety equipment and take safety measures; Whereas the requirements laid down in this Directive should not entail alterations to personal protective equipment whose design and manufacture complied with Community directives relating to safety and health at work; Whereas provision should be made for descriptions which Member States may use when laying down general rules for the use of individual protective equipment; Whereas, pursuant to Decision 74/325/EEC (7), 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 with a view to drawing up proposals in this field, SECTION I GENERAL PROVISIONS Article 1 Subject 1. This Directive, which is the third individual directive within the meaning of Article 16 (1) of Directive 89/391/EEC, lays down minimum requirements for personal protective equipment used by workers at work. 2. The provisions of Directive 89/391/EEC are fully applicable to the whole scope referred to in paragraph 1, without prejudice to more restrictive and/or specific provisions contained in this Directive. Article 2 Definition 1. For the purposes of this Directive, personal protective equipment shall mean all equipment designed to be worn or held by the worker to protect him against one or more hazards likely to endanger his safety and health at work, and any addition or accessory designed to meet this objective. 2. The definition in paragraph 1 excludes: (a) ordinary working clothes and uniforms not specifically designed to protect the safety and health of the worker; (b) equipment used by emergency and rescue services; (c) personal protective equipment worn or used by the military, the police and other public order agencies; (d) personal protective equipment for means of road transport; (e) sports equipment; (f) self-defence or deterrent equipment; (g) portable devices for detecting and signalling risks and nuisances. Article 3 General rule Personal protective equipment shall be used when the risks cannot be avoided or sufficiently limited by technical means of collective protection or by measures, methods or procedures of work organization. SECTION II EMPLOYERS' OBLIGATIONS Article 4 General provisions 1. Personal protective equipment must comply with the relevant Community provisions on design and manufacture with respect to safety and health. All personal protective equipment must: (a) be appropriate for the risks involved, without itself leading to any increased risk; (b) correspond to existing conditions at the workplace; (c) take account of ergonomic requirements and the worker's state of health; (d) fit the wearer correctly after any necessary adjustment. 2. Where the presence of more than one risk makes it necessary for a worker to wear simultaneously more than one item of personal protective equipment, such equipment must be compatible and continue to be effective against the risk or risks in question. 3. The conditions of use of personal protective equipment, in particular the period for which it is worn, shall be determined on the basis of the seriousness of the risk, the frequency of exposure to the risk, the characteristics of the workstation of each worker and the performance of the personal protective equipment. 4. Personal protective equipment is, in principle, intended for personal use. If the circumstances require personal protective equipment to be worn by more than one person, appropriate measures shall be taken to ensure that such use does not create any health or hygiene problem for the different users. 5. Adequate information on each item of personal protective equipment, required under paragraphs 1 and 2, shall be provided and made available within the undertaking and /or establishment. 6. Personal protective equipment shall be provided free of charge by the employer, who shall ensure its good working order and satisfactory hygienic condition by means of the necessary maintenance, repair and replacements. However, Member States may provide, in accordance with their national practice, that the worker be asked to contribute towards the cost of certain personal protective equipment in circumstances where use of the equipment is not exclusive to the workplace. 7. The employer shall first inform the worker of the risks against which the wearing of the personal protective equipment protects him. 8. The employer shall arrange for training and shall, if appropriate, organize demonstrations in the wearing of personal protective equipment. 9. Personal protective equipment may be used only for the purposes specified, except in specific and exceptional circumstances. It must be used in accordance with instructions. Such instructions must be understandable to the workers. Article 5 Assessment of personal protective equipment 1. Before choosing personal protective equipment, the employer is required to assess whether the personal protective equipment he intends to use satisfies the requirements of Article 4(1) and (2). This assessment shall involve: (a) an analysis and assessment of risks which cannot be avoided by other means; (b) the definition of the characteristics which personal protective equipment must have in order to be effective against the risks referred to in (a), taking into account any risks which this equipment itself may create; (c) comparison of the characteristics of the personal protective equipment available with the characteristics referred to in (b). 2. The assessment provided for in paragraph 1 shall be reviewed if any changes are made to any of its elements. Article 6 (8) Rules for use 1. Without prejudice to Articles 3, 4 and 5, Member States shall ensure that general rules are established for the use of personal protective equipment and/or rules covering cases and situations where the employer must provide the personal protective equipment, taking account of Community legislation on the free movement of such equipment. These rules shall indicate in particular the circumstances or the risk situations in which, without prejudice to the priority to be given to collective means of protection, the use of personal protective equipment is necessary. Annexes I, II and III, which constitute a guide, contain useful information for establishing such rules. 2. When Member States adapt the rules referred to in paragraph 1, they shall take account of any significant changes to the risk, collective means of protection and personal protective equipment brought about by technological developments. 3. Member States shall consult the employers' and workers' organization on the rules referred to in paragraphs 1 and 2. Article 7 Information for workers Without prejudice to Article 10 of Directive 89/391 /EEC, workers and/or their representatives shall be informed of all measures to be taken with regard to the health and safety of workers when personal protective equipment is used by workers at work. Article 8 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, including the Annexes thereto. SECTION III MISCELLANEOUS PROVISIONS Article 9 Adjustment of the Annexes Alterations of a strictly technical nature to Annexes I, II and III resulting from: — the adoption of technical harmonization and standardization directives relating to personal protective equipment, and/or — technical progress and changes in international regulations and specifications or knowledge in the field of personal protective equipment, shall be adopted in accordance with the procedure provided for in Article 17 of Directive 89/391/EEC. Article 10 Final provisions 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 immediately inform the Commission thereof. 2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt, as well as those already adopted, in the field covered by this Directive. 3. 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 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. 4. The Commission shall report periodically to the European Parliament, the Council and the Economic and Social Committee on the implementation of the Directive in the light of paragraphs 1,2 and 3. Article 11 This Directive is addressed to the Member States.

31989L0655

1989

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 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 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 the said 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 communication from the Commission on its programme concerning safety, hygiene and health at work (4) provides for the adoption of a directive on the use of work equipment at work; 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 the organization of safety and health at work; Whereas compliance with the minimum requirements designed to guarantee a better standard of safety and health in the use of work equipment is essential to ensure the safety and health of workers; 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 (6); whereas, therefore, the provisions of the said Directive are fully applicable to the scope of the use of work equipment by workers at work without prejudice to more restrictive and/or specific provisions contained in this Directive; Whereas this Directive constitutes a practical aspect of the realization of the social dimension of the internal market; Whereas, pursuant to Directive 83/189/EEC (7), Member States are required to notify the Commission of any draft technical regulations relating to machines, equipment and installations; Whereas, pursuant to Decision 74/325/EEC (8), 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, SECTION I GENERAL PROVISIONS Article 1 Subject 1. This Directive, which is the second individual directive within the meaning of Article 16 (1) of Directive 89/391/EEC, lays down minimum safety and health requirements for the use of work equipment by workers at work, as defined in Article 2. 2. The provisions of Directive 89/391/EEC are fully applicable to the whole scope referred to in paragraph 1, without prejudice to more restrictive and/or specific provisions contained in this Directive. Article 2 Definitions For the purposes of this Directive, the following terms shall have the following meanings: (a) 'work equipment': any machine, apparatus, tool or installation used at work; (b) 'use of work equipment': any activity involving work equipment such as starting or stopping the equipment, its use, transport, repair, modification, maintenance and servicing, including, in particular, cleaning; (c) 'danger zone': any zone within and/or around work equipment in which an exposed worker is subject to a risk to his health or safety; (d) 'exposed worker': any worker wholly or partially in a danger zone; (e) 'operator': the worker or workers given the task of using work equipment. SECTION II EMPLOYERS' OBLIGATIONS Article 3 General obligations 1. The employer shall take the measures necessary to ensure that the work equipment made available to workers in the undertaking and/or establishment is suitable for the work to be carried out or properly adapted for that purpose and may be used by workers without impairment to their safety or health. In selecting the work equipment which he proposes to use, the employer shall pay attention to the specific working conditions and characteristics and to the hazards which exist in the undertaking and/or establishment, in particular at the workplace, for the safety and health of the workers, and/or any additional hazards posed by the use of work equipment in question. 2. Where it is not possible fully so to ensure that work equipment can be used by workers without risk to their safety or health, the employer shall take appropriate measures to minimize the risks. Article 4 Rules concerning work equipment 1. Without prejudice to Article 3, the employer must obtain and/or use: (a) work equipment which, if provided to workers in the undertaking and/or establishment for the first time after 31 December 1992, complies with: i(i) the provisions of any relevant Community directive which is applicable; (ii) the minimum requirements laid down in the Annex, to the extent that no other Community directive is applicable or is so only partially; (b) work equipment which, if already provided to workers in the undertaking and/or establishment by 31 December 1992, complies with the minimum requirements laid down in the Annex no later than four years after that date. 2. The employer shall take the measures necessary to ensure that, throughout its working life, work equipment is kept, by means of adequate maintenance, at a level such that it complies with the provisions of paragraph 1 (a) or (b) as applicable. Article 5 Work equipment involving specific risks When the use of work equipment is likely to involve a specific risk to the safety or health of workers, the employer shall take the measures necessary to ensure that: - the use of work equipment is restricted to those persons given the task of using it; - in the case of repairs, modifications, maintenance or servicing, the workers concerned are specifically designated to carry out such work. Article 6 Informing workers 1. Without prejudice to Article 10 of Directive 89/391/EEC, the employer shall take the measures necessary to ensure that workers have at their disposal adequate information and, where appropriate, written instructions on the work equipment used at work. 2. The information and the written instructions must contain at least adequate safety and health information concerning: - the conditions of use of work equipment, - foreseeable abnormal situations, - the conclusions to be drawn from experience, where appropriate, in using work equipment. 3. The information and the written instructions must be comprehensible to the workers concerned. Article 7 Training of workers Without prejudice to Article 12 of Directive 89/391/EEC, the employer shall take the measures necessary to ensure that: - workers given the task of using work equipment receive adequate training, including training on any risks which such use may entail, - workers referred to in the second indent of Article 5 receive adequate specific training. Article 8 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, including the Annexes thereto. SECTION III MISCELLANEOUS PROVISIONS Article 9 Amendment to the Annex 1. Addition to the Annex of the supplementary minimum requirements applicable to specific work equipment referred to in point 3 thereof shall be adopted by the Council in accordance with the procedure laid down in Article 118a of the Treaty. 2. Strictly technical adaptations of the Annex as a result of: - the adoption of directives on technical harmonization and standardization of work equipment, and/or - technical progress, changes in international regulations or specifications or knowledge in the field of work equipment shall be adopted, in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC. Article 10 Final provisions 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 forthwith inform the Commission thereof. 2. 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. 3. 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 employers and workers. The Commission shall accordingly inform the European Parliament, the Council, the Economic and Social Committee, and the Advisory Committee on Safety, Hygiene and Health Protection at Work. 4. 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 to 3. Article 11 This Directive is addressed to the Member States.

31989L0629

1989

COUNCIL DIRECTIVE of 4 December 1989 on the limitation of noise emission from civil subsonic jet aeroplanes (89/629/EEC) Having regard to the Treaty establishing the European Economic Community, and in particular Article 84 (2) thereof, Having regard to the proposal of 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 application of noise emission standards to civil subsonic jet aeroplanes has significant consequences for the provision of air transport services, in particular where such standards impose restrictions on the type of aeroplanes that may be operated by airlines, encourage investment in the latest and quietest aeroplanes available and facilitate the better use of existing capacity, including that of airports; whereas Directive 80/51/EEC (4), as amended by Directive 83/206/EEC (5) fixes limits on the emission of such noise; Whereas the priority programme of the Council for the study of air transport questions refers to emission from aeroplanes including noise; Whereas the programme of action of the European Communities on the environment (6) shows clearly the importance of the problem of noise and, in particular, the need to take action against noise due to air traffic; Whereas aeroplane noise should be further reduced, taking into account environmental factors, technical feasibility and economic consequences; Whereas, therefore, it is appropriate to restrict the addition of civil subsonic jet aeroplanes to Member States' registers to those which comply with the standards specified in Part II, Chapter 3, Volume 1 of Annex 16 to the Convention on International Civil Aviation, 2nd edition, 1988; whereas in conjunction with the creation of an area without internal frontiers, it would be reasonable to exclude from this non-addition rule aeroplanes entered in Member States' national registers on 1 November 1990; whereas, due to the freedom of movement such a rule would allow, it is essential that exemptions be limited and that those granted be closely monitored and restricted in time; Whereas common rules for this purpose should be introduced on a reasonable time-scale to ensure a harmonized approach throughout the Community supplementing existing rules; whereas this is particularly important in view of the recent impetus given to liberalization of European air traffic; Whereas the work undertaken by the Community in cooperation with other international bodies has indicated that limiting the addition to Member States' registers of aeroplanes which are unable to meet the noise certification standards specified in Chapter 3 of the abovementioned Annex 16, would in itself be of limited environmental benefit, and should therefore be considered only as a first stage, to be followed by measures to limit the operation of aeroplanes which do not comply with the standards of Chapter 3 of the said Annex 16, Article 1 1. The objective of this Directive is to lay down stricter rules for the limitation of noise emission from civil subsonic jet aeroplanes. 2. This Directive shall not apply to aeroplanes with a maximum take-off mass of 34 000 kg or less and a capacity of 19 or less seats. Article 2 1. Member States shall ensure that as from 1 November 1990 civil subsonic jet aeroplanes registered after that date in their territory, may not be operated in their territory or in the territory of another Member State unless granted a noise certificate to the standards at least equal to those specified in Part II, Chapter 3, Volume 1 of Annex 16 to the Convention on International Civil Aviation, 2nd edition 1988. 2. Paragraph 1 shall not apply to aeroplanes entered on Member States' national registers on 1 November 1990. 3. The territory mentioned in paragraph 1 shall not include the overseas departments referred to in Article 227 (2) of the Treaty. Article 3 Member States shall take the necessary measures to ensure that the objective set out in Article 1 (1) is not circumvented by, for example, any form of leasing agreement. Article 4 Member States may grant exemptions from Article 2 for: (a) aeroplanes of historic interest; (b) aeroplanes used by an operator of a Member State before 1 November 1989 under hire purchase or leasing contracts still in effect, and which in this context have been registered in a non-Member State; (c) aeroplanes leased to an operator of a non-Member State which for that reason have been temporarily removed from a Member State's register; (d) an aeroplane which replaces one which has been accidentally destroyed and which the operator is unable to replace by a comparable aeroplane available on the market with noise certification as laid down in Article 2 (1), provided that the registration of the replacement aeroplane is carried out within the year following the destruction in question; (e) aeroplanes powered by engines with a by-pass ratio of 2 or more. Article 5 Member States may grant exemptions from Article 2 for an initial period of up to three years renewable for periods of up to two years, providing that such exemptions expire by 31 December 1995 for: — aeroplanes which are leased from a non-Member State on a short-term basis, provided that the operator demonstrates that this is the normal practice in his sector of the industry and that the pursuit of his operations would otherwise be adversely affected, — aeroplanes in respect of which an operator demonstrates that the pursuit of his operations would otherwise be adversely affected to an unreasonable extent. Article 6 1. A Member State granting exemptions shall inform the competent authorities of the Member States and the Commission of the fact. 2. Member States shall recognize the exemptions granted by other Member States pursuant to Articles 4 and 5. Article 7 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 30 September 1990. 2. Member States shall communicate to the Commission the text of the provisions which they adopt in the field covered by this Directive. Article 8 This Directive is addressed to the Member States.

31989L0662

1989

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 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 Community is to adopt measures designed to establish the internal market progressively over a period expiring on 31 December 1992; Whereas the harmonious operation of the common organization of the market in livestock products and products of animal origin implies the dismantling of veterinary barriers to the development of intra-Community trade in the products concerned; whereas in this respect the free movement of agricultural products is a fundamental feature of the common organization of markets and should facilitate the rational development of agricultural production and the optimum use of the factors of production. Whereas in the veterinary field frontiers are currently being used for carrying out checks aimed at safeguarding public health and animal health; Whereas the ultimate aim is to ensure that veterinary checks are carried out at the place of dispatch only; whereas the attainment of this objective implies the harmonization of the basic requirements relating to the safeguarding of public health and animal health; Whereas with a view to the completion of the internal market, pending the attainment of this objective, the emphasis should be placed on the checks to be carried out at the place of dispatch and in organizing those that could be carried out at the place of destination; whereas such a solution would entail the suspension of veterinary checks at the Community's internal frontiers; Whereas this solution implies increased confidence in the veterinary checks carried out by the State of dispatch; whereas the latter must ensure that such veterinary checks are carried out in an appropriate manner; Whereas in the State of destination spot veterinary checks could be carried out at the place of destination; whereas, however, in the event of a serious presumption of irregularity, the veterinary check could be carried out while the goods are in transit; Whereas it is for the Member States to specify in a plan to be submitted the manner in which they intend to carry out the checks and whereas these plans should be the subject of Community approval; Whereas provision must be made for the action to be taken where a veterinary check discloses that the consignment is irregular; whereas in such a situation three possible solutions may be singled out: the aim of the first would be to provide for the regularization of incorrect documents, that of the second to avert any danger where it is found that there has been an outbreak of an epizootic disease, any new serious and contagious disease or other cause likely to constitute a serious hazard to animals or to human health, while the third would arise where the goods do not satisfy the requirements laid down for reasons other than those referred to above; Whereas provision should be made for a procedure for resolving conflicts which could arise concerning consignments from an establishment, production centre or undertaking; Whereas provision must be made for protective measures; whereas in this area, especially for reasons of effectiveness, responsibility must rest firstly with the Member State of dispatch; whereas the Commission must be able to act speedily, in particular by way of on-the-spot visits and adopting measures appropriate to the situation. Whereas in order to be effective, the rules laid down by this Directive must cover all goods that are subject in the case of intra-Community trade to veterinary requirements; Whereas, however, with regard to certain epizootic diseases, different health situations still prevail in the Member States and whereas, pending a Community approach on the methods to combat these diseases, the question of checking intra-Community trade in livestock should for the time being be left to one side and a documentary check should be permitted during transport; whereas, in view of the current state of harmonization and pending Community rules, goods that are not the subject of harmonized rules should comply with the requirements of the State of destination provided that the latter are in conformity with Article 36 of the Treaty; Whereas the provisions of existing Directives should be adapted to the new rules laid down in this Directive; Whereas these rules should be re-examined before the end of 1993; Whereas the Commission should be entrusted with the task of adopting measures for applying this Directive; whereas, to that end, provision should be made for procedures establishing close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee, Article 1 Member States shall ensure that the veterinary checks to be carried out on products of animal origin which are covered by the Directives listed in Annex A or by Article 14 and which are intended for trade are no longer carried out, without prejudice to Article 6, at frontiers but are carried out in accordance with this Directive. Article 2 For the purposes of this Directive: 1. 'Veterinary check' means any physical check and/or administrative formality which applies to the products referred to in Article 1 and which is intended for the protection, direct or otherwise, of public or animal health; 2. 'trade' means trade between Member States in goods within the meaning of Article 9 (2) of the Treaty; 3. 'establishment' means any undertaking which produces, stores or processes the products referred to in Article 1; 4. 'competent authority' means the central authority of a Member State competent to carry out veterinary checks or any authority to which it has delegated that competence; 5. 'official veterinarian' means the veterinarian appointed by the competent central authority of the Member State. CHAPTER I Checks at origin Article 3 1. Member States shall ensure that the only products intended for trade are those referred to in Article 1 which have been obtained, checked, marked and labelled in accordance with Community rules for the destination in question and which are accompanied to the final consignee mentioned therein by a health certificate, animal-health certificate or by any other document provided for by Community veterinary rules. The establishments of origin shall ensure, by constant self-supervision, that such products satisfy the requirements of the first subparagraph. Without prejudice to the monitoring duties assigned to the official veterinarian under Community legislation, the competent authority shall carry out regular checks on establishments in order to satisfy itself that products intended for trade comply with Community requirements or, in the cases referred to in paragraph 3 of this Article and Article 14, with the requirements of the Member State of destination. Where there are grounds for suspecting that requirements are not being met, the competent authority shall carry out the necessary checks and, if the suspicion is confirmed, take the appropriate measures, which may include withdrawing approval. 2. Where the transport operation involves several places of destination, products must be grouped together in as many batches as there are places of destination. Each batch must be accompanied by the aforementioned certificate or document. Where the products referred to in Article 1 are intended for export to a third country, the transport operation must remain under customs supervision up to the point of exit from Community territory. 3. Member States which make optional imports from certain third countries shall inform the Commission and the other Member States of the existence of such imports. Where products are brought into Community territory by a Member State other than those referred to above, that Member State shall carry out a documentary check on the origin and destination of the goods in accordance with Article 6 (1). Member States of destination shall prohibit the products concerned from being sent on from their territory unless they are bound for another Member State using the same option. Article 4 1. Member States of dispatch shall take the necessary measures to ensure that operators comply with veterinary requirements at all stages of the production, storage, marketing and transport of the products referred to in Article 1. In particular, they shall ensure that: - the products obtained in accordance with the directives referred to in Annex A are checked in the same way, from a veterinary viewpoint, whether they are intended for intra-Community trade or for the national market, - the products covered by Annex B are not dispatched to the territory of another Member State, if they cannot be marketed on their own territory for reasons justified by Article 36 of the Treaty. 2. Member States of dispatch shall take the appropriate administrative, legal or penal measures to penalize any infringement of veterinary legislation by natural or legal persons where it is found that Community rules have been infringed, in particular where it is found that the certificates or documents drawn up do not correspond to the actual state of the products or that public health stamps have been affixed to products which do not comply with those rules. CHAPTER II Checks on arrival at the destination Article 5 1. Member States of destination shall implement the following measures: (a) The competent authority may, at the places of destination of goods, check by means of non-discriminatory veterinary spot-checks that the requirements of Article 3 have been complied with; it may take samples at the same time. Furthermore, where the competent authority of the Member State of transit or of the Member State of destination has information leading it to suspect an infringement, checks may also be carried out during the transport of goods in its territory, including checks on compliance as regards the means of transport; (b) where the products referred to in Article 1 originating in another Member State are intended: - for an establishment placed under the responsibility of an official veterinarian, the latter must ensure that only products that meet the requirements of Article 3 (1) with respect to marking and accompanying documents or, in the case of the products referred to in Annex B, are accompanied by the document stipulated by the rules of the country of destination, are admitted to that establishment, - for an approved intermediary who divides up the batches or for a commercial undertaking with many branches, or any establishment not subject to permanent supervision, the latter must check, before the batch is divided up or marketed, that the said marks, certificate, or documents referred to in the first indent are present and notify the competent authority of any irregularity or anomaly, - for other consignees, particularly where the batch is partially unloaded during transport, the batch must be accompanied, in accordance with Article 3 (1), by the original of the certificate referred to in the first indent. The guarantees which must be furnished by the consignees referred to in the second and third indents shall be specified in an agreement with the competent authority to be signed at the time of the prior registration provided for in paragraph 3. The competent authority shall carry out random checks to verify compliance with those guarantees. 2. Without prejudice to Article 4, where the Community standards laid down by Community rules have not been set and in the case provided for in Article 14, the Member State of destination may require, with due regard for the general provisions of the Treaty, that the establishment of origin must apply the standards in force under the national rules of that Member State. The Member State of origin shall ensure that the product in question comply with those requirements. 3. Operators who have products delivered to them from another Member State or who completely divide up a batch of such products: (a) shall be subject, if so requested by the competent authority, to prior registration; (b) shall keep a register in which such deliveries are recorded; (c) must, if so requested by the competent authority, report the arrival of products from another Member State, to the extent necessary to carry out the checks referred to in paragraph 1; (d) keep for a period of not less than six months to be specified by the competent authority, the health certificates or documents referred to in Article 3 for presentation to the competent authority should the latter so request. 4. The detailed rules for implementing this Article shall be adopted in accordance with the procedure laid down in Article 18. 5. The Council, acting on the basis of a Commission report accompanied by any proposals for amendments, shall re-examine this Article within a period of three years from the implementation of this Directive. Article 6 1. Member States shall ensure that during the checks carried out at the places where products from a third country may be brought into Community territory, such as ports, airports and frontier posts with third countries, the following measures are taken: (a) a documentary check is made on the products' origin; (b) where products are imported from third countries, they must be sent, under customs supervision, to inspection posts in order that veterinary checks may be carried out. The products referred to in Annex A may not be given customs clearance unless those checks have shown that they comply with Community rules. The products referred to in Annex B and those which are the subject of optional imports in accordance with Article 3 (3) which, after having been brought into Community territory, are to be sent to the territory of another Member State, must: - either undergo veterinary checks to show that they comply with the rules of the Member State of destination, - or, after a solely visual check to establish that the documents and the products tally, be sent under customs supervision to the place of destination where veterinary checks must be carried out; (c) products of Community origin shall be subject to the rules of inspection laid down in Article 5. 2. However, as from 1 January 1993 and by way of derogation from paragraph 1, all products transported by regular, direct means of transport linking two geographical points of the Community shall be subject to the rules of inspection laid down in Article 5. Article 7 1. If, during a check carried out at the place of destination of a consignment or during transport, the competent authorities of a Member State establish: (a) the presence of agents responsible for a disease named in Directive 82/894/EEC (4), as last amended by Commission Decision 89/162/EEC (5), a zoonosis or disease, or any cause likely to constitute a serious hazard to animals or humans, or that the products come from an area infected by an epizootic disease, they shall, except as regards animal-health aspects, in the case of products subject to one of the treatments referred to in Article 4 of Directive 80/215/EEC (6), as last amended by Directive 88/660/EEC (7), order the batch to be destroyed or used in any other way laid down by Community rules. Costs relating to the destruction of the batch shall be borne by the consignor or his representative. The competent authorities of the Member State of destination shall immediately notify the competent authorities of the other Member States and the Commission by telex of the findings arrived at, the decisions taken and the reasons for such decisions. The protective measures provided for in Article 9 may be applied. In addition, at the request of a Member State and in accordance with the procedure laid down in Article 17, the Commission may, in order to deal with situations not provided for by Community legislaton, adopt any measure necessary to arrive at a concerted approach by the Member States; (b) that the goods do not meet the conditions laid down by Community directives, or, in the absence of decisions on the Community standards provided for by the directives, by national standards, they may, provided that health and animal-health considerations so permit, give the consignor or his representative the choice of: - destroying the goods, or - using the goods for other purposes, including returning them with the authorization of the competent authority of the country of the establishment of origin. b) - However, if the certificate or the documents are found to contain irregularities, the consignor must be granted a period of grace before recourse is had to this last possibility. 2. In accordance with the procedure laid down in Article 18, the Commission shall draw up a list of the agents and diseases referred to in paragraph 1, and detailed rules for the application of this Article. Article 8 1. In the cases provided for in Article 7, the competent authority of the Member State of destination shall contact the competent authorities of the Member State of dispatch without delay. The latter authorities shall take all necessary measures and notify the competent authority of the first Member State of the nature of the checks carried out, the decisions taken and the reasons for such decisions. If the authority of the first Member State fears that such measures are inadequate, the competent authorities of the two Member States shall together seek ways and means of remedying the situation; if appropriate this may involve an on-the-spot inspection. Where the checks provided for in Article 7 show repeated irregularities, the competent authority of the Member State of destination shall inform the Commission and the veterinary departments of the other Member States. The Commission, at the request of the competent authority of the Member State of destination or on its own initiative, and taking into account the nature of the infringements established, may: - send a mission of inspection to the establishment concerned, or - instruct an official veterinarian, whose name shall be on a list to be prepared by the Commission at the suggestion of the Member States, and who is acceptable to the various parties concerned, to check the facts in the establishment concerned, - request the competent authority to intensify its sampling of the products of the establishment concerned. It shall inform the Member States of its findings. Where these measures are taken to deal with repeated irregularities on the part of an establishment, the Commission shall charge any expenses occasioned by the application of the indents of the foregoing subparagraph to the establishment involved. Pending the Commission's findings, the Member State of dispatch must, at the request of the Member State of destination, intensify checks on products coming from the establishment in question, and if there are serious animal health or public health grounds, suspend approval. The Member State of destination may, for its part, intensify checks on products coming from the same establishment. At the request of one of the two Member States concerned - where the irregularities are confirmed by the expert's opinion - the Commission must, in accordance with the procedure laid down in Article 17, take the appropriate measures, which may go as far as authorizing the Member States to prohibit provisionally the bringing into their territory of products coming from that establishment. These measures must be confirmed or reviewed as soon as possible in accordance with the procedure laid down in Article 17. The general rules for the application of this Article shall be adopted in accordance with the procedure set out in Article 18. 2. Rights of appeal existing under the laws in force in the Member States against decisions by the competent authorities shall not be affected by this Directive. Decisions taken by the competent authority of the State of destination and the reasons for such decisions shall be notified to the consignor or his representative and to the competent authority of the Member State of dispatch. If the consignor or his representative so requests, the said decisions and reasons shall be forwarded to him in writing with details of the rights of appeal which are available to him under the law in force in the Member State of destination and of the procedure and time limits applicable. However, in the event of a dispute, and without prejudice to the aforementioned rights of appeal, the two parties concerned may, if they so agree, within a maximum period of one month, submit the dispute for the assessment of an expert whose name appears on a list of Community experts to be drawn up by the Commission; the cost of consulting the expert shall be borne by the Community. Such experts shall issue their opinions within not more than 72 hours. The parties shall abide by the expert's opinion, with due regard for Community veterinary legislation. 3. The costs of returning the consignment, storing the goods, putting them to other uses or destroying them shall be borne by the consignee. CHAPTER III Common provisions Article 9 1. Each Member State shall immediately notify the other Member States and the Commission of any outbreak in its territory, other than an outbreak of diseases referred to in Directive 82/894/EEC, of any zoonoses, diseases or other cause likely to constitute a serious hazard to animals or to human health. The Member State of origin shall immediately implement the control or precautionary measures provided for in Community rules, in particular the determination of the buffer zones provided for in those rules, or adopt any other measure which it deems appropriate. The Member State of destination or transit which, in the course of a check referred to in Article 5, has established the existence of one of the diseases or causes referred to in the first subparagraph may, if necessary, take the precautionary measures provided for in Community rules. Pending the measures to be taken in accordance with paragraph 4, the Member State of destination may, on serious public or animal-health grounds, take interim protective measures with regard to the establishments concerned or, in the case of an epizootic disease, with regard to the area of protection provided for in Community rules. The measures taken by Member States shall be notified to the Commission and to the other Member States without delay. 2. At the request of the Member State referred to in the first subparagraph of paragraph 1 or on the initiative of the Commission, one or more Commission representatives may go at once to the place concerned to examine, in collaboration with the competent authorities, what measures have been taken, and shall issue an opinion on those measures. 3. If the Commission has not been informed of the measures taken, or if it considers the measures taken to be inadequate, it may, in collaboration with the Member State concerned and pending the meeting of the Standing Veterinary Committee, take interim protective measures with regard to products from the region affected by the epizootic disease or from a given establishment. These measures shall be submitted to the Standing Veterinary Committee as soon as possible to be confirmed, amended or cancelled in accordance with the procedure laid down in Article 17. 4. The Commission shall in all cases review the situation in the Standing Veterinary Committee at the earliest opportunity. It shall adopt the necessary measures for the products referred to in Article 1 and, if the situation so requires, for the originating products or products derived from those products in accordance with the procedure laid down in Article 17. The Commission shall monitor the situation and, by the same procedure, shall amend or repeal the decisions taken, depending on how the situation develops. 5. Detailed rules for the application of this Article, and in particular the list of zoonoses or causes likely to constitute a serious hazard to human health, shall be adopted in accordance with the procedure laid down in Article 18. Article 10 Each Member State and the Commission shall appoint the veterinary department or departments responsible for carrying out the veterinary checks and collaborating with the other Member States' inspection departments. Article 11 The Member States shall also ensure that the officials of their veterinary departments, if appropriate in collaboration with the officials of other departments empowered to that end, are able in particular to: - carry out inspections of premises, offices, laboratories, installations, means of transport, plant and equipment, cleaning and maintenance products, procedures used for the production and processing of products and the marking and labelling and presentation of those products, - carry out checks on whether staff comply with the requirements laid down in the texts referred to in Annex A, - take samples from products held with a view to being stored or sold, put on the market or transported; - examine documentary or computer material relevant to the checks carried out further to the measures taken pursuant to Article 3 (1). For this purpose, they must receive from the establishments being checked the cooperation necessary for the performance of their duties. Article 12 1. Article 8 (3) and Articles 10 and 11 of Directive 64/433/EEC (8), as last amended by Directive 88/657/EEC (9) are deleted. 2. Article 5 (3) and (4), and Articles 9, 10 and 11 of Directive 71/118/EEC (10) as last amended by Directive 88/657/EEC are deleted. 3. In Directive 74/461/EEC (11) as last amended by Directive 87/489/EEC (12): i(i) Articles 5 (2), (3), (4) and (5) and Articles 6 and 8 are deleted; (ii) in Article 8a, the references to Article 8 are replaced by a reference to Article 9 of Directive 89/662/EEC. 4. Article 7 (3) and Articles 12 and 16 of Directive 77/99/EEC (13), as last amended by Directive 89/227/EEC (14), is deleted. 5. In Directive 80/215/EEC: i(i) Article 5 (2), (3), (4) and (5) and Articles 6 and 7 are deleted; (ii) in Article 7a, the references to Article 7 is replaced by a reference to Article 9 of Directive 89/662/EEC. 6. Article 5 (3) and (4), and Article 7, 8 and 12 of Directive 85/397/EEC (15), as amended by Regulation (EEC) No 3768/85 (16), are deleted. 7. Article 10 (1) and (3) of Directive 88/657/EEC is deleted. 8. Articles 8 and 9 of Directive 89/437/EEC (17) are deleted. 9. In Annex B to Directive 72/462/EEC (18), the following shall be added to the certificate: 'Name and address of first consignee'. Article 13 1. The following Article is added to Directives 64/433/EEC and 71/118/EEC: 'Article 19 The Rules laid down in Directive 89/662/EEC (*) concerning veterinary checks applicable in intra-Community trade, with a view to the completion of the internal market, shall apply in particular to checks at origin, to the organization of and follow-up to the checks to be carried out by the Member State of destination, and to the protective measures to be implemented. (*) OJ No L 395, 30. 12. 1989, p. 13'. 2. The following Article is added to Directives 72/461/EEC and 80/215/EEC: 'Article 15 The rules laid down in Directive 89/662/EEC (*) concerning veterinary checks applicable in intra-Community trade, with a view to the completion of the internal market, shall apply in particular to checks at origin, to the origanization of and follow-up to the checks to be carried out by the Member State of destination, and to the protective measures to be implemented. (*) OJ No L 395, 30. 12. 1989, p. 13.' 3. The following Article is added to Directive 77/99/EEC: 'Article 24 The Rules laid down in Directive 89/662/EEC (*) concerning veterinary checks applicable in intra-Community trade, with a view to the completion of the internal market, shall apply in particular to checks at origin, to the organization of and follow-up to the checks to be carried out by the Member State of destination, and to the protective measures to be implemented. (*) OJ No L 395, 30. 12. 1989, p. 13.' 4. The following Article shall be added to Directives 85/397/EEC and 88/657/EEC: 'Article 18 The Rules laid down in Directive 89/662/EEC (*) concerning veterinary checks applicable in intra-Community trade, with a view to the completion of the internal market, shall apply in particular to checks at origin, to the organization of and follow-up to the checks to be carried out by the Member State of destination, and to the protective measures to be implemented. (*) OJ No L 395, 30. 12. 1989, p. 13'. 5. The following Article is added to Directive 88/437/EEC: 'Article 17 The Rules laid down in Directive 89/662/EEC (*) concerning veterinary checks applicable in intra-Community trade, with a view to the completion of the internal market, shall apply in particular to checks at origin, to the organization of and follow-up to the checks to be carried out by the Member State of destination, and to the protective measures to be implemented. (*) OJ No L 395, 30. 12. 1989, p. 13'. Article 14 Until 31 December 1992, trade in the products listed in Annex B shall, pending the adoption of Community rules, be subject to the rules on control laid down by this Directive, in particular those laid down in Article 5 (2). Member States shall communicate before the date laid down in Article 19 the conditions and procedures currently applicable to trade in the products referred to in the first subparagraph. The Council, acting on a proposal from the Commission, shall determine the final arrangements applicable to trade in the products listed in Annex B before 31 December 1991. Article 15 In Article 9 of Directive 64/432/EEC (19), the following point is inserted: '2a. One or more Commission representatives may, at the request of a Member State or at the initiative of the Commission itself, go at once to the place concerned to examine, in cooperation with the competent authorities, the measures taken and issue an opinion on those measures.'. Article 16 1. Member States shall submit to the Commission no later than three months before the date laid down in Article 19 (1) a programme setting out the national measures to be taken to achieve the stated objective of this Directive, in particular the frequency of checks. 2. The Commission shall examine the programmes communicated by the Member States in accordance with paragraph 1. 3. Each year and for the first time in 1991, the Commission shall address to the Member States a recommendation on a programme of checks for the following year; the Standing Veterinary Committee will have expressed its opinion on the recommendation in advance. This recommendation may be subject to later adaptations. Article 17 1. Where the procedure laid down in this Article is to be used, matters shall without delay be referred by the Chairman, either on his own initiative or at the request of a Member State, to the Standing Veterinary Committee (hereinafter called the 'Committee') set up by Decision 68/361/EEC (20). 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. 4. 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 15 days 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 decided against the said measures by a simple majority. Article 18 1. Where the procedure laid down in this Article is to be used, matters shall without delay be referred by the Chairman, either on his own initiative or at the request of a Member State, to the Standing Veterinary Committee (hereinafter called 'the Committee') set up by Decision 68/361/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. 3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. 4. 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 Commission shall adopt the proposed measures and implement them immediately, save where the Council has decided against the said measures by a simple majority. CHAPTER IV Transitional and Final Provisions Article 19 1. Before 31 December 1990 the Council shall act by a qualified majority on the Commission proposal concerning veterinary checks in intra-Community trade in live animals. Before the date referred to in the first subparagraph, the Council, acting by a qualified majority on a proposal from the Commission, shall decide on the rules and general principles applicable to checks on imports from third countries of products covered by this Directive. In the same way, the check posts on the external frontiers, together with the requirements that these posts will have to satisfy, shall be fixed before that date. 2. Before 31 December 1992 the Council shall review the provisions of this Directive on the basis of a report from the Commission on the experience gained, accompanied by any relevant proposals, on which it will decide by a qualified majority. Article 20 Until 31 December 1992 and in order to permit the gradual implementation of the checking arrangements laid down by this Directive, Member States may, by way of derogation from Article 5 (1): - maintain documentary checks during transport on meat and on products deriving therefrom, in order to ensure compliance with the specific requirements laid down by Community rules concerning foot and mouth disease and swine fever, - operate documentary checks during transport on products imported from third countries intended for them. Article 21 The Council, acting by a qualified majority on a proposal from the Commission, shall, before 1 October 1992, determine the arrangements applicable on the expiry of the transitional provisions laid down in Article 20. Article 22 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on a date to be fixed in the decision to be taken before 31 December 1990, in accordance with the second subparagraph of Article 19 (1), but not later than 31 December 1991. However, the Hellenic Republic shall have a further period of one year within which to comply therewith. Article 23 This Directive is addressed to the Member States.

31989L0646

1989

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 and amending Directive 77/780/EEC 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 this Directive is to constitute the essential instrument for 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 of both the freedom of establishment and the freedom to provide financial services, in the field of credit institutions; Whereas this Directive will join the body of Community legislation already enacted, in particular 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 (4), as last amended by Directive 86/524/EEC (5), Council Directive 83/350/EEC of 13 June 1983 on the supervision of credit institutions on a consolidated basis (6), Council Directive 86/635/EEC of 8 December 1986 on the annual and consolidated accounts of banks and other financial institutions (7) and Council Directive 89/299/EEC of 17 April 1989 on the own funds of credit institutions (8); Whereas the Commission has adopted recommendations 87/62/EEC on large exposures of credit institutions (9) and 87/63/EEC concerning the introduction of deposit- guarantee schemes (10); Whereas the approach which has been adopted is to achieve only the essential harmonization necessary and sufficient to secure the mutual recognition of authorization and of prudential supervision systems, making possible the granting of a single licence recognized throughout the Community and the application of the principle of home Member State prudential supervision; Whereas, in this context, this Directive can be implemented only simultaneously with specific Community legislation dealing with the additional harmonization of technical matters relating to own funds and solvency ratios; Whereas, moreover, the harmonization of the conditions relating to the reorganization and winding-up of credit institutions is also proceeding; Whereas the arrangements necessary for the supervision of the liquidity, market, interest-rate and foreign-exchange risks run by credit institutions will also have to be harmonized; Whereas the principles of mutual recognition and of home Member State control require the competent authorities of ¹ ¹ ¹ each Member State not to grant authorization or to withdraw it where factors such as the activities programme, the geographical distribution or the activities actually carried on make it quite clear that a credit institution has opted for the legal system of one Member State for the purpose of evading the stricter standards in force in another Member State in which it intends to carry on or carries on the greater part of its activities; whereas, for the purposes of this Directive, a credit institution shall be deemed to be situated in the Member State in which it has its registered office; whereas the Member States must require that the head office be situated in the same Member State as the registered office; Whereas the home Member State may also establish rules stricter than those laid down in Articles 4, 5, 11, 12 and 16 for institutions authorized by its competent authorities; Whereas responsibility for supervising the financial soundness of a credit institution, and in particular its solvency, will rest with the competent authorities of its home Member State; whereas the host Member State's competent authorities will retain responsibility for the supervision of liquidity and monetary policy; whereas the supervision of market risk must be the subject of close cooperation between the competent authorities of the home and host Member States; Whereas the harmonization of certain financial and investment services will be effected, where the need exists, by specific Community instruments, with the intention, in particular, of protecting consumers and investors; whereas the Commission has proposed measures for the harmonization of mortgage credit in order, inter alia, to allow mutual recognition of the financial techniques peculiar to thal sphere; Whereas, by virtue of mutual recognition, the approach chosen permits credit institutions authorized in their home Member States to carry on, throughout the Community, any or all of the activities listed in the Annex by establishing branches or by providing services; Whereas the carrying-on of activities not listed in the Annex shall enjoy the right of establishment and the freedom to provide services under the general provisions of the Treaty; Whereas it is appropriate, however, to extend mutual recognition to the activities listed in the Annex when they are carried on by financial institutions which are subsidiaries of credit institutions, provided that such subsidiaries are covered by the consolidated supervision of their parent undertakings and meet certain strict conditions; Whereas the host Member State may, in connection with the exercise of the right of establishment and the freedom to provide services, require compliance with specific provisions of its own national laws or regulations on the part of institutions not authorized as credit institutions in their home Member States and with regard to activities not listed in the Annex provided that, on the one hand, such provisions are compatible with Community law and are intended to protect the general good and that, on the other hand, such institutions or such activities are not subject to equivalent rules under the legislation or regulations of their home Member States; Whereas the Member States must ensure that there are no obstacles to carrying on activities receiving mutual recognition in the same manner as in the home Member State, as long as the latter do not conflict with legal provisions protecting the general good in the host Member State; Whereas the abolition of the authorization requirement with respect to the branches of Community credit institutions once the harmonization in progress has been completed necessitates the abolition of endowment capital; whereas Article 6 (2) constitutes a first transitional step in this direction, but does not, however, affect the Kingdom of Spain or the Portuguese Republic, as provided for in the Act concerning the conditions of those States' accession to the Community; Whereas there is a necessary link between the objective of this Directive and the liberalization of capital movements being brought about by other Community legislation; whereas in any case the measures regarding the liberalization of banking services must be in harmony with the measures liberalizing capital movements; whereas where the Member States may, by virtue of Council Directive 88/361/EEC of 24 June 1988 for the implementation of Article 67 of the Treaty (11), invoke safeguard clauses in respect of capital movements, they may suspend the provision of banking services to the extent necessary for the implementation of the abovementioned safeguard clauses; Whereas the procedures established in Directive 77/780/EEC, in particular with regard to the authorization of branches of credit institutions authorized in third countries, will continue to apply to such institutions; whereas those branches will not enjoy the freedom to provide services under the second paragraph of Article 59 of the Treaty or the freedom 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 made by undertakings governed by the laws of third countries are subject to a procedure intendet to ensure that Community credit institutions receive reciprocal treatment in the third countries in question; Whereas the authorizations granted to credit institutions by the competent national authorities pursuant to this Directive will have Community-wide, and no longer merely nationwide, application, and whereas 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 other third countries; whereas, to that end, this Directive provides for procedures for negotitating with third countries and, as a last resort, for the possibility of taking measures involving the suspension of new applications for authorization or the restriction of new authorizations; Whereas the smooth operation of the internal banking market will require not only legal rules but also close and regular cooperation between the competent authorities of the Member States; whereas for the consideration of problems concerning individual credit institutions the Contact Committee set up between the banking supervisory authorities, referred to in the final recital of Directive 77/780/EEC, remains the most appropriate forum; whereas that Committee is a suitable body for the mutual exchange of information provided for in Article 7 of that Directive; Whereas that mutual information procedure will not in any case replace the bilateral collaboration established by Article 7 of Directive 77/780/EEC; whereas the competent host Member State authorities can, without prejudice to their powers of control proper, continue either, in an emergency, on their own initiative or following the initiative of the competent home Member State authorities to verify that the activities of a credit institution established within their territories comply with the relevant laws and with the principles of sound administrative and accounting procedures and adequate internal control; Whereas technical modifications to the detailed rules laid down in this Directive may from time to time be necessary to take account of new developments in the banking sector; whereas the Commission shall accordingly make such modifications as are necessary, after consulting the Banking Advisory Committee, within the limits of the implementing powers conferred on the Commission by the Treaty; whereas that Committee shall act as a ´Regulatory' Committee, according to the rules of procedure laid down in Article 2, procedure III, variant (b), of Council Decision 87/373/EEC of 13 July 1987 laying down the procedures for the exercise of implementing powers conferred on the Commission (12), TITLE I Definitions and scope Article 1 For the purpose of this Directive: 1. ´credit institution' shall mean a credit institution as defined in the first indent of Article 1 of Directive 77/780/EEC; 2. ´authorization' shall mean authorization as defined in the second indent of Article 1 of Directive 77/780/EEC; 3. ´branch' shall mean a place of business which forms a legally dependent part of a credit institution and which carries out directly all or some of the transactions inherent in the business of credit institutions; any number of places of business set up in the same Member State by a credit institution with headquarters in another Member State shall be regarded as a single branch; 4. ´own funds' shall mean own funds as defined in Directive 89/299/EEC; 5. ´competent authorities' shall mean competent authorities as defined in Article 1 of Directive 83/350/EEC; 6. ´financial institution' shall mean an undertaking other than a credit institution the principal activity of which is to acquire holdings or to carry on one or more of the activities listed in points 2 to 12 in the Annex; 7. ´home Member State' shall mean the Member State in which a credit institution has been authorized in accordance with Article 3 of Directive 77/780/EEC; 8. ´host Member State' shall mean the Member State in which a credit institution has a branch or in which it provides services; 9. ´control' shall mean the relationship between a parent undertaking and a subsidiary, as defined in Article 1 of Directive 83/349/EEC (13), or a similar relationship between any natural or legal person and an undertaking; 10. ´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 5 and 11 and of the other levels of holding referred to in Article 11, the voting rights referred to in Article 7 of Directive 88/627/EEC (14) shall be taken into consideration; 11. ´initial capital' shall mean capital as defined in Article 2 (1) (1) and (2) of Directive 89/299/EEC; 12. ´parent undertaking' shall mean a parent undertaking as defined in Articles 1 and 2 of Directive 83/ 349/EEC; 13. ´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 at the head of those undertakings; 14. ´solvency ratio' shall mean the solvency coefficient of credit institutions calculated in accordance with Directive 89/647/EEC (15). Article 2 1. This Directive shall apply to all credit institutions. 2. It shall not apply to the institutions referred to in Article 2 (2) of Directive 77/780/EEC. 3. A credit institution which, as defined in Article 2 (4) (a) of Directive 77/780/EEC, is affiliated to a central body in the same Member State may be exempted from the provisions of Articles 4, 10 and 12 of this Directive provided that, without prejudice to the application of those provisions to the central body, the whole as constituted by the central body together with its affiliated institutions is subject to the abovementioned provisions on a consolidated basis. In cases of exemption, Articles 6 and 18 to 21 sahll apply to the whole as constituted by the central body together with its affiliated institutions. Article 3 The Member States shall prohibit persons or undertakings that are not credit institutions from carrying on the business of taking deposits or other repayable funds from the public. This prohibition shall not apply to the taking of deposits or other funds repayable by a Member State or by a Member State's regional or local authorities or by public international bodies of which one or more Member States are members or to cases expressly covered by national or Community legislation, provided that those activities are subject to regulations and controls intended to protect depositors and investors and applicable to those cases. TITLE II Harmonization of authorization conditions Article 4 1. The competent authorities shall not grant authorization in cases where initial capital is less than ECU 5 million. 2. The Member States shall, however, have the option of granting authorization to particular categories of credit institutions the initial capital of which is less than that prescribed in paragraph 1. In such cases: (a) the initial capital shall not be less than ECU 1 million; (b) the Member States concerned must notify the Commission of their reasons for making use of the option provided for in this paragraph; (c) when the list referred to in Article 3 (7) of Directive 77/780/EEC is published, the name of each credit institution that does not have the minimum capital prescribed in paragraph 1 shall be annotated to that effect; (d) within five years of the date referred to in Article 24 (1), the Commission shall draw up a report on the application of this paragraph in the Member States, for the attention of the Banking Advisory Committee referred to in Article 11 of Directive 77/780/EEC. Article 5 The competent authorities shall not grant authorization for the taking-up of the business of credit institutions before 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 a credit institution, they are not satisfied as to the suitability of the abovementioned shareholders or members. Article 6 1. Host Member States may no longer require authorization, as provided for in Article 4 of Directive 77/780/EEC, or endowment capital for branches of credit institutions authorized in other Member States. The establishment and supervision of such branches shall be effected as prescribed in Articles 13, 19 and 21 of this Directive. 2. Until the entry into force of the provisions implementing paragraph 1, host Member States may not, as a condition of the authorization of branches of credit institutions, authorized in other Member States, require initial endowment capital exceeding 50 % of the initial capital required by national rules for the authorization of credit institutions of the same nature. 3. Credit institutions shall be entitled to the free use of the funds no longer required pursuant to paragraphs 1 and 2. Article 7 There must be prior consultation with the competent authorities of the other Member State involved on the authorization of a credit institution which is: - a subsidiary of a credit institution authorized in another Member State, or - a subsidiary of the parent undertaking of a credit institution authorized in another Member State, or - controlled by the same persons, whether natural or legal, as control a credit institution authorized in another Member State. TITLE III Relations with third countries Article 8 The competent authorities of the Member States shall inform the Commission: (a) of any authorization of a direct or indirect subsidiary one or more parent undertakings of which are governed by the laws of a third country. The Commission shall inform the Banking Advisory Committee accordingly; (b) whenever such a parent undertaking acquires a holding in a Community credit institution such that the latter would become its subsidiary. The Commission shall inform the Banking Advisory Committee accordingly. When authorization is granted to the direct or indirect subsidiary of one or more parent undertakings governed by the law of third countries, the structure of the group shall be specified in the notification which the competent authorities shall address to the Commission in accordance with Article 3 (7) of Directive 77/780/EEC. Article 9 1. The Member States shall inform the Commission of any general difficulties encountered by their credit institutions in establishing themselves or carrying on banking activities in a third country. 2. Initially no later than six months before the application of this Directive and thereafter periodically, the Commission shall draw up a report examining the treatment accorded to Community credit institutions in third countries, in the terms referred to in paragraphs 3 and 4, as regards establishment and the carrying-on of banking activities, and the acquisition of holdings in third-country credit institutions. The Commission shall submit those reports to the Council, together with any appropriate proposals. 3. Whenever it appears to the Commission, either on the basis of the reports referred to in paragraph 2 or on the basis of other information, that a third country is not granting Community credit institutions effective market access comparable to that granted by the Community to credit institutions from that third country, the Commission may submit proposals to the Council for the appropriate mandate for negotiation with a view to obtaining comparable competitive opportunities for Community credit institutions. The Council shall decide by a qualified majority. 4. Whenever it appears to the Commission, either on the basis of the reports referred to in paragraph 2 or on the basis of other information that Community credit institutions in a third country do not receive national treatment offering the same competitive opportunities as are available to domestic credit institutions and the 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 initiating negotiations, in accordance with the procedure laid down in Article 22 (2), that the competent authorities of the Member States must limit or suspend their decisions regarding requests pending at the moment of the decision or future requests for authorizations and the acquisition of holdings by direct or indirect parent undertakings governed by the laws of the third country in question. The duration of the measures referred to 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 suspension may not apply to the setting up of subsidiaries by credit institutions or their subsidiaries duly authorized in the Community, or to the acquisition of holdings in Community credit institutions by such institutions or subsidiaries. 5. Whenever it appears to the Commission that one of the situations described in paragraphs 3 and 4 obtains, the Member States shall inform it at its request: (a) of any request for the authorization of a direct or indirect subsidiary one or more parent undertakings of which are governed by the laws of the third country in question; (b) whenever they are informed in accordance with Article 11 that such an undertaking proposes to acquire a holding in a Community credit institution such that the latter would become its subsidiary. This obligation to provide information shall lapse whenever an agreement is reached with the third country referred to in paragraph 3 or 4 or when the measures referred to in the second and third subparagraphs of paragraph 4 cease to apply. 6. Measures taken pursuant to this Article shall comply with the Community's obligations under any international agreements, bilateral or multilateral, governing the taking-up and pursuit of the business of credit institutions. TITLE IV Harmonization of the conditions governing pursuit of the business of credit institutions Article 10 1. A credit institution's own funds may not fall below the amount of initial capital required pursuant to Article 4 at the time of its authorization. 2. The Member States may decide that credit institutions already in existence when the Directive is implemented, the own funds of which do not attain the levels prescribed for initial capital in Article 4, may continue to carry on their activities. In that event, their own funds may not fall below the highest level reached after the date of the notification of this Directive. 3. If control of a credit institution falling within the category referred to in paragraph 2 is taken by a natural or legal person other than the person who controlled the institution previously, the own funds of that institution must attain at least the level prescribed for initial capital in Article 4. 4. However, in certain specific circumstances and with the consent of the competent authorities, where there is a merger of two or more credit institutions falling within the category referred to in paragraph 2, the own funds of the institution resulting from the merger may not fall below the total own funds of the merged institutions at the time of the merger, as long as the appropriate levels pursuant to Article 4 have not been attained. 5. However, if, in the cases referred to in paragraphs 1, 2 and 4, the own funds should be reduced, the competent authorities may, where the circumstances justify it, allow an institution a limited period in which to rectify its situation or cease its activities. Article 11 1. The Member States shall require any natural or legal person who proposes to acquire, directly or indirectly a qualifying holding in a credit institution first to inform the competent authorities, telling them of the size of the intended holding. Such a person must 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 held by him would reach or exceed 20 %, 33 % or 50 % or so that the credit institution would become his subsidiary. Without prejudice to the provisions of paragraph 2 the competent authorities 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 credit institution, they are not satisfied as to the suitablility of the person referred to in the first subparagraph. If they do not oppose the plan referred to in the first subparagraph, they may fix a maximum period for its implementation. 2. If the acquirer of the holdings referred to in paragraph 1 is a credit institution authorized in another Member State or the parent undertaking of a credit institution authorized in another Member State or a natural or legal person controlling a credit institution authorized in another Member State and if, as a result of that acquisition, the institution in which the acquirer proposes to acquire a holding would become a subsidiary or subject to the control of the acquirer, the assessment of the acquisition must be the subject of the prior consultation referred to in Article 7. 3. The Member States shall require any natural or legal person who proposes to dispose, directly or indirectly, of a qualifying holding in a credit institution first to inform the competent authorities, telling them of 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 credit institution would cease to be his subsidiary. 4. On becoming aware of them, credit institutions shall inform the competent authorities 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 3. 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. 5. The Member States shall require that, where 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 institution, the competent authorities 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 12 1. No credit institution may have a qualifying holding the amount of which exceeds 15 % of its own funds in an undertaking which is neither a credit institution, nor a financial institution, nor an undertaking carrying on an activity referred to in the second subparagraph of Article 43 (2) (f) of Directive 86/635/EEC. 2. The total amount of a credit institution's qualifying holdings in undertakings other than credit institutions, financial institutions or undertakings carrying on activities referred to in the second subparagraph of Article 43 (2) (f) of Directive 86/635/EEC may not exceed 60 % of its own funds. 3. The Member States need not apply the limits laid down in paragraphs 1 and 2 to holdings in insurance companies as defined in Directive 73/239/EEC (16), as last amended by Directive 88/357/EEC (17), and Directive 79/267/EEC (18), as last amended by the Act of Accession of 1985. 4. Shares held temporarily during a financial reconstruction or rescue operation or during the normal course of underwriting or in an institution's own name on behalf of others shall not be counted as qualifying holdings for the purpose of calculating the limits laid down in paragraphs 1 and 2. Shares which are not financial fixed assets as defind in Article 35 (2) of Directive 86/635/EEC shall not be included. 5. The limits laid down in paragraphs 1 and 2 may be exceeded only in exceptional circumstances. In such cases, however, the competent authorities shall require a credit institution either to increase its own funds or to take other equivalent measures. 6. Compliance with the limits laid down in paragraphs 1 and 2 shall be ensured by means of supervision and monitoring on a consolidated basis in accordance with Directive 83/350/EEC. 7. Credit institutions which, on the date of entry into force of the provisions implementing this Directive, exceed the limits laid down in paragraphs 1 and 2 shall have a period of 10 years from that date in which to comply with them. 8. The Member States may provide that the competent authorities shall not apply the limits laid down in paragraph 1 and 2 if they provide that 100 % of the amounts by which a credit institution's qualifying holdings exceed those limits must be covered by own funds and that the latter shall not be included in the calculation of the solvency ratio. If both the limits laid down in paragraphs 1 and 2 are exceeded, the amount to be covered by own funds shall be the greater of the excess amounts. Article 13 1. The prudential supervision of a credit institution, including that of the activities it carries on in accordance with Article 18, shall be the responsibility of the competent authorities of the home Member State, without prejudice to those provisions of this Directive which give responsibility to the authorities of the host Member State. 2. Home Member State competent authorities shall require that every credit institution have sound administrative and accounting procedures and adequate internal control mechanisms. 3. Paragraphs 1 and 2 shall not prevent supervision on a consolidated basis pursuant to Directive 83/350/EEC. Article 14 1. In Article 7 (1) of Directive 77/780/EEC, the end of the second sentence is hereby replaced by the following: ´and all information likely to facilitate the monitoring of such institutions, in particular with regard to liquidity, solvency, deposit guarantees, the limiting of large exposures, administrative and accounting procedures and internal control mechanisms'. 2. Host Member States shall retain responsibility in cooperation with the competent authorities of the home Member State for the supervision of the liquidity of the branches of credit institutions pending further coordination. Without prejudice to the measures necessary for the reinforcement of the European Monetary System, host Member States shall retain complete responsibility for the measures resulting from the implementation of their monetary policies. Such measures may not provide for discriminatory or restrictive treatment based on the fact that a credit institution is authorized in another Member State. 3. Without prejudice to further coordination of the measures designed to supervise the risks arising out of open positions on markets, where such risks result from transactions carried out on the financial markets of other Member States, the competent authorities of the latter shall collaborate with the competent authorities of the home Member State to ensure that the institutions concerned take steps to cover those risks. Article 15 1. Host Member States shall provide that, where a credit institution authorized in another Member State carries on its activities through a branch, the competent authorities of the home Member State may, after having first informed the competent authorities of the host Member State, carry out themselves or through the intermediary of persons they appoint for that purpose on-the-spot verification of the information referred to in Article 7 (1) of Directive 77/780/EEC. 2. The competent authorities of the home Member State may also, for purposes of the verification of branches, have recourse to one of the other procedures laid down in Article 5 (4) of Directive 83/350/EEC. 3. This Article shall not affect the right of the competent authorities of the host Member State to carry out, in the discharge of their responsibilities under this Directive, on-the-spot verifications of branches established within their territory. Article 16 Article 12 of Directive 77/780/EEC is hereby replaced by the following: ´Article 12 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 collective form, such that individual institutions cannot be identified, without prejudice to cases covered by criminal law. Nevertheless, where a credit institution has been declared bankrupt or is being compulsorily wound up, confidential information which does not concern third parties involved in attempts to rescue that credit institution may be divulged in civil or commercial proceedings. 2. Paragraph 1 shall not prevent the competent authorities of the various Member States from exchanging information in accordance with the Directives applicable to credit institutions. 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 credit institutions are met and to facilitate monitoring, on a non-consolidated or consolidated basis, of the conduct of such business, especially with regard to the monitoring of liquidity, solvency, large exposures, and administrative and accounting procedures and internal control mechanisms, or - to impose sanctions, or - in an administrative appeal against a decision of the competent authority, or - in court proceedings initiated pursuant to Article 13 or to special provisions provided for in the Directives adopted in the field of credit institutions. 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 supervision of other financial organizations and insurance companies and the authorities responsible for the supervision of financial markets, - bodies involved in the liquidation and bankruptcy of credit institutions and in other similar procedures, - persons responsible for carrying out statutory audits of the accounts of credit institutions and other financial institutions, in the discharge of their supervisory functions, and the disclosure to bodies which administer deposit-guarantee schemes of information necessary to the exercise of their functions. The information received shall be subject to the conditions of professional secrecy indicated in paragraph 1. 6. Nor shall the provisions of this Article preclude a competent authority from disclosing to those central banks which do not supervise credit institutions 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 indicated in paragraph 1. 7. In addition, notwithstanding the provisions referred to in paragraphs 1 and 4, the 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 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. However, the 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 15 (1) and (2) of Directive 89/646/EEC (19) 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. (20) OJ No L 386, 30. 12. 89, p.1.' Article 17 Without prejudice to the procedures for the withdrawal of authorizations and the provisions of criminal law, the Member States shall provide that their respective competent authorities may, as against credit institutions or those who effectively control the business of credit institutions which breach laws, regulations or administrative provisions concerning the supervision or pursuit of their activities, adopt or impose in respect of them penalties or measures aimed specifically at ending observed breaches or the causes of such breaches. TITLE V Provisions relating to the freedom of establishment and the freedom to provide services Article 18 1. The Member States shall provide that the activities listed in the Annex may be carried on within their territories, in accordance with Articles 19 to 21, either by the establishment of a branch or by way of the provision of services, by any credit institution authorized and supervised by the competent authorities of another Member State, in accordance with this Directive, provided that such activities are covered by the authorization. 2. The Member States shall also provide that the activities listed in the Annex may be carried on within their territories, in accordance with Articles 19 to 21, either by the establishment of a branch or by way of the provision of services, by any financial institution from another Member State, whether a subsidiary of a credit institution or the jointly-owned subsidiary of two or more credit institutions, the memorandum and articles of association of which permit the carrying on of those activities and which fulfils each of the following conditions: - the parent undertaking or undertakings must be authorized as credit institutions in the Member State by the law of which the subsidiary is governed, - the activities in question must actually be carried on within the territory of the same Member State, - the parent undertaking or undertakings must hold 90 % or more of the voting rights attaching to shares in the capital of the subsidiary, - the parent undertaking or undertakings must satisfy the competent authorities regarding the prudent management of the subsidiary and must have declared, with the consent of the relevant home Member State competent authorities, that they jointly and severally guarantee the commitments entered into by the subsidiary, - the subsidiary must be effectively included, for the activities in question in particular, in the consolidated supervision of the parent undertaking, or of each of the parent undertakings, in accordance with Directive 83/350/EEC, in particular for the calculation of the solvency ratio, for the control of large exposures and for purposes of the limitation of holdings provided for in Article 12 of this Directive. Compliance with these conditions must be verified by the competent authorities of the home Member State and the latter must supply the subsidiary with a certificate of compliance which must form part of the notification referred to in Articles 19 and 20. The competent authorities of the home Member State shall esnure the supervision of the subsidiary in accordance with Articles 10 (1), 11, 13, 14 (1), 15 and 17 of this Directive and Articles 7 (1) and 12 of Directive 77/780/EEC. The provisions mentioned in this paragraph shall be applicable to subsidiaries, subject to the necessary modifications. In particular, the words ´credit institution' should be read as ´financial institution fulfilling the conditions laid down in Article 18 (2)' and the word ´authorization' as ´memorandum and articles of association'. The second subparagraph of Article 19 (3) shall read: ´The home Member State competent authorities shall also communicate the amount of own funds of the subsidiary financial institution and the consolidated solvency ratio of the credit institution which is its parent undertaking.' If a financial institution eligible under this paragraph should cease to fulfil any of the conditions imposed, the home Member State shall notify the competent authorities of the host Member State and the activities carried on by that institution in the host Member State shall become subject to the legislation of the host Member State. Article 19 1. A credit institution wishing to establish a branch within the territory of another Member State shall notify the competent authorities of its home Member State. 2. The Member State shall require every credit institution wishing to establish a branch in another Member State to provide the following information when effecting the notification referred to 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 structural organization 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 the credit institution, taking into account the activities envisaged, they shall within three months of receipt of the information referred to in paragraph 2 communicate that information to the competent authorities of the host Member State and shall inform the institution concerned accordingly. The home Member State competent authorities shall also communicate the amount of own funds and the solvency ratio of the credit institution and, pending subsequent coordination, details of any deposit-guarantee scheme which is intended to ensure the protection of depositors in the branch. 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 institution concerned within three months of receipt of all the information. That refusal or failure to reply shall be subject to a right to apply to the courts in the home Member State. 4. Before the branch of a credit institution commences its activities the competent authorities of the host Member State shall, within two months of receiving the information mentioned in paragraph 3, prepare for the supervision of the credit institution in accordance with Article 21 and if necessary indicate the conditions under which, in the interest of the general good, those activities 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 in the event of the expiry of the period provided for in paragraph 4 without receipt of any communication from the latter, the branch may be established and commence its activities. 6. In the event of a change in any of the particulars communicated pursuant to paragraph 2 (b), (c) or (d) or in the deposit-guarantee scheme referred to in paragraph 3 a credit institution shall give written notice of the change in question to the competent authorities of the home and host Member States at least one month before making the change so as to enable the competent authorities of the home Member State to take a decision pursuant to paragraph 3 and the competent authorities of the host Member State to take a decision on the change pursuant to paragraph 4. Article 20 1. Any credit institution wishing to exercise the freedom to provide services by carrying on its activities within the territory of another Member State for the first time shall notify the competent authorities of the home Member State of the activities on the list in the Annex which it intends to carry on. 2. The competent authorities of the home Member State shall, within one month of receipt of the notification mentioned in paragraph 1, send that notification to the competent authorities of the host Member State. Article 21 1. Host Member State may, for statistical purposes, require that all credit institutions having branches within their territories shall report periodically on their activities in those host Member States to the competent authorities of those host Member States. In discharging the responsibilities imposed on them in Article 14 (2) and (3), host Member States may require that branches of credit institutions from other Member States provide the same information as they require from national credit institutions for that purpose. 2. Where the competent authorities of a host Member State ascertain that an institution having a branch or providing services within its territory is not complying with the legal provisions adopted in that State pursuant to the provisions of this Directive involving powers of the host Member State competent authorities, those authorities shall require the institution concerned to put an end to that irregular situation. 3. If the institution 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 competent authorities of the home Member State shall, at the earliest opportunity, take all appropriate measures to ensure that the institution concerned puts an end to that irregular situation. The nature of those measures shall be communicated to the competent authorities of the host Member State. 4. If, despite the measures taken by the home Member State or because such measures prove inadequate or are not available in the Member State in question, the institution persists in violating the legal rules referred to in paragraph 2 in force in the host Member State, the latter State may, after informing the competent authorities of the home Member State, take appropriate measures to prevent or to punish further irregularities and, insofar as is necessary, to prevent that institution from initiating further transactions within its territory. The Member States shall ensure that within their territories it is possible to serve the legal documents necessary for these measures on credit institutions. 5. The foregoing provisions shall not affect the power of host Member States to take appropriate measures to prevent or to punish irregularities committed within their territories which are contrary to the legal rules they have adopted in the interest of the general good. This shall include the possibility of preventing offending institutions from initiating any further transactions within their territories. 6. Any measure adopted pursuant to paragraphs 3, 4 and 5 involving penalties or restrictions on the exercise of the freedom to provide services must be properly justified and communicated to the institution concerned. Every such measure shall be subject to a right of appeal to the courts in the Member State the authorities of which adopted it. 7. Before following the procedure provided for in paragraphs 2 to 4, the competent authorities of the host Member State may, in emergencies, take any precautionary measures necessary to protect the interests of depositors, investors and others to 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. The Commission may, after consulting the competent authorities of the Member States concerned, decide that the Member State in question must amend or abolish those measures. 8. Host Member States may exercise the powers conferred on them under this Directive by taking appropriate measures to prevent or to punish irregularities committed within their territories. This shall include the possibility of preventing institutions from initiating further transactions within their territories. 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 institution concerned from initiating further transactions within its territory and to safeguard the interests of depositors. Every two years the Commission shall submit a report on such cases to the Banking Advisory Committee. 10. The Member States shall inform the Commission of the number and type of cases in which there has been a refusal pursuant to Article 19 or in which measures have been taken in accordance with paragraph 4. Every two years the Commission shall submit a report on such cases to the Banking Advisory Committee. 11. Nothing this Article shall prevent credit institutions with head offices in other Member States from advertising their services through all available means of communication in the host Member State, subject to any rules governing the form and the content of such advertising adopted in the interest of the general good. TITLE VI Final provisions Article 22 1. The technical adaptations to be made to this Directive in the following areas shall be adopted in accordance with the procedure laid down in paragraph 2: - expansion of the content of the list referred to in Article 18 and set out in the Annex or adaptation of the terminology used in that list to take account of developments on financial markets, - alteration of the amount of initial capital prescribed in Article 4 to take account of developments in the economic and monetary field, - the areas in which the competent authorities must exchange information as listed in Article 7 (1) of Directive 77/780/EEC, - clarification of the definitions in order to ensure uniform application of this Directive throughout 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 on and the framing of definitions in accordance with subsequent acts on credit institutions and related matters. 2. The Commission shall be assisted by a committee composed of representatives of the Member States and chaired by a representative of the Commission. The Commission representative shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. 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 in 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 concerning the measures to be taken. The Council shall act by a qualified majority. If the Council does not act within three months of the referral to it the Commission shall adopt the measures proposed, unless the Council has decided against those measures by a simple majority. Article 23 1. Branches which have commenced their activities, in accordance with the provisions in force in their host Member States, 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 19 (1) to (5). They shall be governed, from the date of that entry into force, by Articles 15, 18, 19 (6) and 21. They shall benefit pursuant to Article 6 (3). 2. Article 20 shall not affect rights acquired by credit institutions providing services before the entry into force of the provisions adopted in implementation of this Directive. Article 24 1. Subject to paragraph 2, the Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive by the later of the two dates laid down for the adoption of measures to comply with Directives 89/299/EEC and 89/647/EEC and at the latest by 1 January 1993. They shall forthwith inform the Commission thereof. 2. The Member States shall adopt the measures necessary for them to comply with Article 6 (2) by 1 January 1990. 3. 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 25 This Directive is addressed to the Member States.

31989L0647

1989

Council Directive 89/647/EEC of 18 December 1989 on a solvency ratio for credit institutions Having regard to the Treaty establishing the European Economie 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 this Directive is the outcome of work carried out by the Banking Advisory Committee, which, pursuant to Article 6 (4) of 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 (4), as last amended by Directive 89/646/EEC (5), is responsible for making suggestions to the Commission with a view to coordinating the coefficients applicable in the Member States; Whereas the establishment of an appropriate solvency ratio plays a central role in the supervision of credit institutions; Whereas a ratio which weights assets and off-balance-sheet items according to the degree of credit risk is a particularly useful measure of solvency; Whereas the development of common standards for own funds in relation to assets and off-balance-sheet items exposed to credit risk is, accordingly, an essential aspect of the harmonization necessary for the achievement of the mutual recognition of supervision techniques and thus the completion of the internal banking market; Whereas, in that respect, this Directive must be considered in conjunction with other specific instruments also harmonizing the fundamental techniques of the supervision of credit institutions; Whereas this Directive must also be seen as complementary to Directive 89/646/EEC, which lays out the broader framework of which this Directive is an integral part; Whereas, in a common banking market, institutions are required to enter into direct competition with one another and whereas the adoption of common solvency standards in the form of a minimum ratio will prevent distortions of competition and strengthen the Community banking system; Whereas this Directive provides for different weightings to be given to guarantees issued by different financial institutions; whereas the Commission accordingly undertakes to examine whether the Directive taken as a whole significantly distorts competition between credit institutions and insurance companies and, in the light of that examination, to consider whether any remedial measures are justified; Whereas the minimum ratio provided for in this Directive reinforces the capital of credit institutions in the Community; whereas a level of 8 % has been adopted following a statistical survey of capital requirements in force at the beginning of 1988; Whereas measurement of and allowance for interest-rate, foreign-exchange and other market risks are also of great importance in the supervision of credit institutions; whereas the Commission will accordingly, in cooperation with the competent authorities of the Member States and all other bodies working towards similar ends, continue to study the techniques available; whereas it will then make appropriate proposals for the further harmonization of supervision rules relating to those risks; whereas in so doing it will keep a special watch on the possible interaction between the various banking risks and consequently pay particular attention to the consistency of the various proposals; Whereas, in making proposals for rules for the supervision of investment services and the adequacy of the capital of entities operating in that area, the Commission will ensure that equivalent requirements are applied in respect of the level of own funds, if the same type of business is transacted and identical risks are assumed; Whereas the specific accounting technique to be used for the calculation of solvency ratios must take account of the provisions of Council Directive 86/635/EEC of 8 December 1986 on the annual accounts and consolidated accounts of banks and other financial institutions (6), which incorporates certain adaptations of the provisions of Council Directive 83/349/EEC (7), as amended by the Act of Accession of Spain and Portugal; whereas, pending transposition of the provisions of those Directives into the national laws of the Member States, the use of a specific accounting technique for the calculation of solvency ratios should be left to the discretion of the Member States; Whereas the application of a 20 % weighting to credit institutions' holdings of mortgage bonds may unsettle a national financial market on which such instruments play a preponderant role; whereas, in this case, provisional measures are taken to apply a 10 % risk weighting; Whereas technical modifications to the detailed rules laid down in this Directive may from time to time be necessary to take account of new developments in the banking sector; whereas the Commission will accordingly make such modifications as are necessary, after consulting the Banking Advisory Committee, within the limits of the implementing powers conferred on the Commission by the provisions of the Treaty; whereas that Committee will act as a ´Regulatory' Committee, according to the rules of procedure laid down in Article 2, procedure III, variant (b), of Council Decision 87/373/EEC of 13 July 1987 laying down the procedures for the exercise of implementing powers conferred on the Commission (8), Scope and definitions Article 1 1. This Directive shall apply to credit institutions as defined the first indent of Article 1 of Directive 77/780/EEC. 2. Notwithstanding paragraph 1, the Member States need not apply this Directive to credit institutions listed in Article 2 (2) of Directive 77/780/EEC. 3. A credit institution which, as defined in Article 2 (4) (a) of Directive 77/780/EEC, is affiliated to a central body in the same Member State, may be exempted from the provisions of this Directive, provided that all such affiliated credit institutions and their central bodies are included in consolidated solvency ratios in accordance with this Directive. 4. Exceptionally, and pending further harmonization of the prudential rules relating to credit, interest-rate and market risks, the Member States may exclude from the scope of this Directive any credit institution specializing in the inter-bank and public-debt markets and fulfilling, together with the central bank, the institutional function of banking-system liquidity regulator, provided that: - the sum of its asset and off-balance-sheet items included in the 50 % and 100 % weightings, calculated in accordance with Article 6, must not normally exceed 10 % of total assets and off-balance-sheet items and shall not in any event exceed 15 % before application of the weightings, - its main activity consists of acting as intermediary between the central bank of its Member State and the banking system, - the competent authority applies adequate systems of supervision and control of its credit, interest-rate and market risks. The Member States shall inform the Commission of the exemptions granted, in order to ensure that they do not result in distortions of competititon. Within three years of the adoption of this Directive, the Commission shall submit to the Council a report together, where necessary, with any proposals it may consider appropriate. Article 2 1. For the purposes of this Directive: - ´competent authorities' shall mean the authorities defined in the fifth indent of Article 1 of Council Directive 83/350/EEC, - ´Zone A' shall comprise all the Member States and all other countries which are full members of the Organization for Economic Cooperation and Development (OECD) and those countries which have concluded special lending arrangements with the International Monetary Fund (IMF) associated with the Fund's General Arrangements to Borrow (GAB), - ´Zone B' shall comprise all countries not in Zone A, - ´Zone A credit institutions' shall mean all credit institutions authorized in the Member States, in acccordance with Article 3 of Directive 77/780/EEC, including their branches in third countries, and all private and public undertakings covered by the definition in the first indent of Article 1 of Directive 77/780/EEC and authorized in other Zone A countries, including their branches, - ´Zone B credit institutions' shall mean all private and public undertakings authorized outside Zone A covered by the definition in the first indent of Article 1 of Directive 77/780/EEC, including their branches within the Community, - ´non-bank sector' shall mean all borrowers other than credit institutions as defined in the fourth and fifth indents, central governments and central banks, regional governments and local authorities, the European Communities, the European Investment Bank and multilateral development banks as defined in the seventh indent, - ´multilateral development banks' shall mean the International Bank for Reconstruction and Development, the International Finance Corporation, the Inter-American Development Bank, the Asian Development Bank, the African Development Bank, the Council of Europe Resettlement Fund, the Nordic Investment Bank and the Caribbean Development Bank, - ´full-risk', ´medium-risk', ´medium/low-risk' and ´low-risk' off-balance-sheet items shall mean the items described in Article 6 (2) and listed in Annex I. 2. For the purposes of Article 6 (1) (b), the competent authorities may include within the concept of regional governments and local authorities non-commercial administrative bodies responsible to regional governments or local authorities, and those non-commercial undertakings owned by central governments, regional governments, local authorities or authorities which, in the view of the competent authorities, exercise the same responsibilities as regional and local authorities. Article 3 General principles 1. The solvency ratio referred to in paragraphs 2 to 7 expresses own funds, as defined in Article 4, as a proportion of total assets and off-balance-sheet items, risk-adjusted in accordance with Article 5. 2. The solvency ratios of credit institutions which are neither parent undertakings as defined in Article 1 of Directive 83/349/EEC nor subsidiaries of such undertakings shall be calculated on an individual basis. 3. The solvency ratios of credit institutions which are parent undertakings shall be calculated on a consolidated basis in accordance with the methods laid down in this Directive and in Directives 83/350/EEC and 86/635/EEC (9). 4. The competent authorities responsible for authorizing and supervising a parent undertaking which is a credit institution may also require the calculation of a subconsolidated or unconsolidated ratio in respect of that parent undertaking and of any of its subsidiaries which are subject to authorization and supervision by them. Where such monitoring of the satisfactory allocation of capital within a banking group is not carried out, other measures must be taken to attain that end. 5. Where the subsidiary of a parent undertaking has been authorized and is situated in another Member State, the competent authorities which granted that authorization shall require the calculation of a subconsolidated or unconsolidated ratio. 6. Notwithstanding paragraph 5, the competent authorities responsible for authorizing the subsidiary of a parent undertaking situated in another Member State may, by way of a bilateral agreement, delegate their responsibility for supervising solvency to the competent authorities which have authorized and which supervise the parent undertaking so that they assume responsibility for supervising the subsidiary in accordance with this Directive. The Commission shall be kept informed of the existence and content of such agreements. It shall forward such information to the other authorities and to the Banking Advisory Committee. 7. Without prejudice to credit institutions' compliance with the requirements of paragraphs 2 to 6, the competent authorities shall ensure that ratios are calculated not less than twice each year, either by credit institutions themselves, which shall communicate the results and any component data required to the competent authorities, or by the competent authorities, using data supplied by the credit institutions. 8. The valuation of assets and off-balance-sheet items shall be effected in accordance with Directive 86/635/EEC. Pending implementation of the provisions of that Directive, valuation shall be left to the discretion of the Member States. Article 4 The numerator: own funds Own funds as defined in Directive 89/299/EEC (10) shall form the numerator of the solvency ratio. Article 5 The denominator: risk-adjusted assets and off-balance-sheet items 1. Degrees of credit risk, expressed as percentage weightings, shall be assigned to asset items in accordance with Articles 6 and 7, and exceptionally Articles 8 and 11. The balance-sheet value of each asset shall then be multiplied by the relevant weighting to produce a risk-adjusted value. 2. In the case of the off-balance-sheet items listed in Annex I, a two-stage calculation as precribed in Article 6 (2) shall be used. 3. In the case of the interest-rate- and foreign- exchange-related off-balance-sheet items referred to in Article 6 (3), the potential costs of replacing contracts in the event of counterparty default shall be calculated by means of one of the two methods set out in Annex II. Those costs shall be multiplied by the relevant counterparty weigthings in Article 6 (1), except that the 100 % weightings as provided for there shall be replaced by 50 % weightings to produce risk-adjusted values. 4. The total of the risk-adjusted values of the assets and off-balance-sheet items mentioned in paragraphs 2 and 3 shall be the denominator of the solvency ratio. Article 6 Risk weightings 1. The following weightings shall be applied to the various categories of asset items, altough the competent authorities may fix higher weightings as they see fit: (a) Zero weighting 1. cash in hand and equivalent items; 2. asset items constituting claims on Zone A central governments and central banks; 3. asset items constituting claims on the European Communities; 4. asset items constituting claims carrying the explicit guarantees of Zone A central governments and central banks; 5. asset items constituting claims on Zone B central governments and central banks, denominated and funded in the national currencies of the borrowers; 6. asset items constituting claims carrying the explicit guarantees of Zone B central governments and central banks, denominated and funded in the national currency common to the guarantor and the borrower; 7. asset items secured, to the satisfaction of the competent authorities, by collateral in the form of Zone A central government or central bank securities, or securities issued by the European Communities, or by cash deposits placed with the lending institution or by certificates of deposit or similar instruments issued by and lodged with the latter; (b) 20 % weighting 1. asset items constituting claims on the European Investment Bank (EIB); 2. asset items constituting claims on multilateral development banks; 3. asset items constituting claims carrying the explicit guarantee of the European Investment Bank (EIB); 4. asset items constituting claims carrying the explicit guarantees of multilateral development banks; 5. asset items constituting claims on Zone A regional governments or local authorities, subject to Article 7; 6. asset items constituting claims carrying the explicit guarantees of Zone A regional governments or local authorities, subject to Article 7; 7. asset items constituting claims on Zone A credit institutions but not constituting such institutions' own funds as defined in Directive 89/299/EEC; 8. asset items constituting claims, with a maturity of one year or less, on Zone B credit institutions, other than securities issued by such institutions which are recognized as components of their own funds; 9. asset items carrying the explicit guarantees of Zone A credit institutions; 10. asset items constituting claims with a maturity of one year or less, carrying the explicit guarantees of Zone B credit institutions; 11. asset items secured, to the satisfaction of the competent authorities, by collateral in the form of securities issued by the EIB or by multilateral development banks; 12. cash items in the process of collection; (c) 50 % weighting 1. loans fully and completely secured, to the satisfaction of the competent authorities, by mortgages on residential property which is or will be occupied or let by the borrower; 2. prepayments and accrued income: these assets shall be subject to the weighting corresponding to the counterparty where a credit institution is able to determine it in accordance with Directive 86/635/EEC. Otherwise, where it is unable to determine the contraparty, it shall apply a flat-rate weighting of 50 %; (d) 100 % weighting 1. asset items constituting claims on Zone B central governments and central banks except where denominated and funded in the national currency of the borrower; 2. asset items constituting claims on Zone B regional governments or local authorities; 3. asset items constituting claims with a maturity of more than one year on Zone B credit institutions; 4. asset items constituting claims on the Zone A or Zone B non-bank sectors; 5. tangible assets within the meaning of assets as listed in Article 4 (10) of Directive 86/635/EEC; 6. holdings of shares, participations and other components of the own funds of other credit institutions which are not deducted from the own funds of the lending institutions; 7. all other assets except where deducted from own funds. 2. The following treatment shall apply to off-balance-sheet items other than those covered in paragraph 3. They shall first be grouped according to the risk groupings set out in Annex I. The full value of the full-risk items shall be taken into account, 50 % of the value of the medium-risk items and 20 % of the medium/low-risk items, while the value of low-risk items shall be set at zero. The second stage shall be to multiply the off-balance-sheet values, adjusted as described above, by the weightings attributable to the relevant counterparties, in accordance with the treatment of asset items prescribed in paragraph 1 and Article 7. In the case of asset sale and repurchase agreements and outright forward purchases, the weightings shall be those attaching to the assets in question and not to the counterparties to the transactions. 3. The methods set out in Annex II shall be applied to the interest-rate and foreign-exchange risks listed in Annex III. 4. Where off-balance-sheet items carry explicit guarantees, they shall be weighted as if they had been incurred on behalf of the guarantor rather than the counterparty. Where the potential exposure arising from off-balance-sheet transactions is fully and completely secured, to the satisfaction of the competent authorities, by any of the asset items recognized as collateral in paragraph 1 (a) (7) or (b) (11), weightings of 0 % or 20 % shall apply, depending on the collateral in question. 5. Where asset and off-balance-sheet items are given a lower weighting because of the existence of explicit guarantees or collateral acceptable to the competent authorities, the lower weighting shall apply only to that part which is guaranteed or which is fully covered by the collateral. Article 7 1. Notwithstanding the requirements of Article 6 (1) (b), the Member States may fix a weighting of 0 % for their own regional governments and local authorities if there is no difference in risk between claims on the latter and claims on their central governments because of the revenue-raising powers of the regional governments and local authorities and the existence of specific institutional arrangements the effect of which is to reduce the chances of default by the latter. A zero weighting fixed in accordance with these criteria shall apply to claims on and off-balance-sheet items incurred on behalf of the regional governments and local authorities in question and claims on others and off-balance-sheet items incurred on behalf of others and guaranteed by those regional governments and local authorities. 2. The Member States shall notify the Commission if they believe a zero weighting to be justified according to the criteria laid down in paragraph 1. The Commission shall circulate that information. Other Member States may offer the credit institutions under the supervision of their competent authorities the possibility of applying a zero weighting where they undertake business with the regional governments or local authorities in question or where they hold claims guaranteed by the latter. Article 8 1. The Member States may apply a weighting of 20 % to asset items which are secured, to the satisfaction of the competent authorities concerned, by collateral in the form of securities issued by Zone A regional governments or local authorities, by deposits placed with Zone A credit institutions other than the lending institution, or by certificates of deposit of similar instruments issued by those credit institutions. 2. The Member States may apply a weighting of 10 % to claims on institutions specializing in the inter-bank and public-debt markets in their home Member States and subject to close supervision by the competent authorities where those asset items are fully and completely secured, to the satisfaction of the competent authorities of the home Member States, by a combination of asset items mentioned in Article 6 (1) (a) and (b) recognized by the latter as constituting adequate collateral. 3. The Member States shall notify the Commission of any provisions adopted pursuant to paragraphs 1 and 2 and of the grounds for such provisions. The Commission shall forward that information to the Member States. The Commission shall periodically examine the implications of those provisions in order to ensure that they do not result in any distortions of competition. Within three years of the adoption of this Directive, the Commission shall submit to the Council a report together, where necessary, with any proposals it may consider appropriate. Article 9 1. The technical adaptations to be made to this Directive in the following areas shall be adopted in accordance with the procedure laid down in paragraph 2: - a temporary reduction in the minimum ratio prescribed in Article 10 or the weightings prescribed in Article 6 in order to take account of specific circumstances, - the definition of ´Zone A' in Article 2, - the definition of ´multilateral development banks' in Article 2, - amendment of the definitions of the assets listed in Article 6 in order to take account of developments on financial markets, - the lists and classification of off-balance-sheet items in Annexes I and III and their treatment in the calculation of the ratio as decribed in Articles 5, 6 and 7 and Annex II, - clarification of the definitions in order to ensure uniform application of this Directive throughout 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 on and the framing of definitions in accordance with subsequent acts on credit institutions and related matters. 2. The Commission shall be assisted by a committee composed of representatives of the Member States and chaired by a representative of the Commission. The Commission representative shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. 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 in 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 concerning the measures to be taken. The Council shall act by a qualified majority. If the Council does not act within three months of the referral to it the Commission shall adopt the measures proposed, unless the Council has decided against those measures by a simple majority. Article 10 1. With effect from 1 January 1993 credit institutions shall be required permanently to maintain the ratio defined in Article 3 at a level of at least 8 %. 2. Notwithstanding paragraph 1, the competent authorities may prescribe higher minimum ratios as they consider appropriate. 3. If the ratio falls below 8 % the competent authorities shall ensure that the credit institution in question takes appropriate measures to restore the ratio to the agreed minimum as quickly as possible. Article 11 1. A credit institution the minimum ratio of which has not reached the 8 % prescribed in Article 10 (1) by the date prescribed in Article 12 (1) must gradually approach that level by successive stages. It may not allow the ratio to fall below the level reached before that objective has been attained. Any fluctuation should be temporary and the competent authorities should be apprised of the reasons for it. 2. For not more than five years after the date prescribed in Article 10 (1) the Member States may fix a weighting of 10 % for the bonds defined in Article 22 (4) of Council Directive 85/611/EEC on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (11), as amended by Directive 88/220/EEC (12), and maintain it for credit institutions when and if they consider it necessary, to avoid grave disturbances in the operation of their markets. Such exceptions shall be reported to the Commission. 3. For not more than seven years after 1 January 1993, Article 10 (1) shall not apply to the Agricultural Bank of Greece. However, the latter must approach the level prescribed in Article 10 (1) by successive stages according to the method described in paragraph 1. 4. By derogation from Article 6 (1) (c) (1), until 1 January 1996 Germany, Denmark and Greece may apply a weighting of 50 % to assets which are entirely and completely secured to the satisfaction of the competent authorities concerned, by mortgages on completed residential property, on offices or on multi-purpose commercial premises, situated within the territories of those three Member States provided that the sum borrowed does not exceed 60 % of the value of the property in question, calculated on the basis of rigorous assessment criteria laid down in statutory or regulatory provisions. 5. Member States may apply a 50 % weighting to property leasing transactions concluded within ten years of the date laid down in Article 12 (1) and concerning assets for business use situated in the country of the head office and governed by statutory provisions whereby the lessor retains full ownership of the rented asset until the tenant exercises his option to purchase. Article 12 1. The Member States shall adopt the measures necessary for them to comply with the provisions of this Directive by 1 January 1991 at the latest. 2. The Member States shall communicate to the Commission the texts of the main laws, regulations and administrative provisions which they adopt in the field covered by this Directive. Article 13 This Directive is addressed to the Member States.

31990L0035

1989

Commission Directive 90/35/EEC of 19 December 1989 defining in accordance with Article 6 of Directive 88/379/EEC the categories of preparations the packaging of which must be fitted with child-resistant fastenings and/or carry a tactile warning of danger 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 Member States' laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous preparations (1), as last amended by Directive 89/178/EEC (2), and in particular Article 6 (3) thereof, Whereas, under Article 6 (2) of Directive 88/379/EEC, containers containing certain categories of dangerous preparations offered or sold to the general public are to be fitted with child-resistant fastenings and/or carry a tactile warning of danger; whereas under Article 6 (3) the categories of dangerous preparations the packaging of which have to be fitted with the abovementioned devices are defined by the procedure set out in Article 21 of Council Directive 67/548/EEC (3), as last amended by Directive 88/490/EEC (4); Whereas all forms of sufficiently child-resistant packages, especially those defined by international standards, can be considered as packages fitted with child-resistant fastenings; 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 Containers of whatever the capacity, containing preparations offered or sold to the general public and labelled as very toxic, toxic or corrosive in accordance with Article 7 of Directive 88/379/EEC and under the conditions laid down in Article 3 thereof shall be fitted with child-resistant fastenings and carry a tactile warning of danger. These fastenings and warnings must conform to the specifications in parts A and B of Annex IX to Directive 67/548/EEC. Article 2 Containers of whatever the capacity, containing preparations offered of sold to the general public and labelled as harmful, extremely flammable or highly flammable in accordance with Article 7 and under the conditions laid down in Article 3 of Directive 88/379/EEC, shall carry a tactile warning of danger. This warning must conform to the specifications in part B of Annex IX to Directive 67/548/EEC. Article 3 By 31 December 1990, Member States shall adopt and publish the provisions necessary to comply with this Directive and shall forthwith inform the Commission thereof. They shall apply these provisions from 10 June 1991 at the latest. Article 4 This Directive is addressed to the Member States.

31989L0666

1989

Eleventh Council Directive 89/666/EEC of 21 December 1989 concerning disclosure requirements in respect of branches opened in a Member State by certain types of company governed by the law of another State 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 facilitate the exercise of the freedom of establishment in respect of companies covered by Article 58 of the Treaty, Article 54 (3) (g) and the general programme on the elimination of restrictions on the freedom of establishment require coordination of the safeguards required of companies and firms in the Member States for the protection of the interests of members and others; Whereas hitherto this coordination has been effected in respect of disclosure by the adoption of the First Directive 68/151/EEC (4) covering companies with share capital, as last amended by the 1985 Act of Accession; whereas it was continued in the field of accounting by the Fourth Directive 78/660/EEC (5) on the annual accounts of certain types of companies, as last amended by the 1985 Act of Accession, the Seventh Directive 83/349/EEC (6) on consolidated accounts, as amended by the 1985 Act of Accession, and the Eighth Directive 84/253/EEC (7) on the persons responsible for carrying out the statutory audits of accounting documents; Whereas these Directives apply to companies as such but do not cover their branches; whereas the opening of a branch, like the creation of a subsidiary, is one of the possibilities currently open to companies in the exercise of their right of establishment in another Member State; Whereas in respect of branches the lack of coordination, in particular concerning disclosure, gives rise to some disparities, in the protection of shareholders and third parties, between companies which operate in other Member States by opening branches and those which operate there by creating subsidiaries; Whereas in this field the differences in the laws of the Member States may interfere with the exercise of the right of establishment; whereas it is therefore necessary to eliminate such differences in order to safeguard, inter alia, the exercise of that right; Whereas to ensure the protection of persons who deal with companies through the intermediary of branches, measures in respect of disclosure are required in the Member State in which a branch is situated; whereas, in certain respects, the economic and social influence of a branch may be comparable to that of a subsidiary company, so that there is public interest in disclosure of the company at the branch; whereas to effect such disclosure it is necessary to make use of the procedure already instituted for companies with share capital within the Community; Whereas such disclosure relates to a range of important documents and particulars and amendments thereto; Whereas such disclosure, with the exception of the powers of representation, the name and legal form and the winding-up of the company and the insolvency proceedings to which it is subject, may be confined to information concerning a branch itself together with a reference to the register of the company of which that branch is part, since under existing Community rules all information covering the company as such is available in that register; Whereas national provisions in respect of the disclosure of accounting documents relating to a branch can no longer be justified following the coordination of national law in respect of the drawing up, audit and disclosure of companies' accounting documents; whereas it is accordingly sufficient to disclose, in the register of the branch, the accounting documents as audited and disclosed by the company; Whereas letters and order forms used by a branch must give at least the same information as letters and order forms used by the company, and state the register in which the branch is entered; Whereas to ensure that the purposes of this Directive are fully realized and to avoid any discrimination on the basis of a company's country of origin, this Directive must also cover branches opened by companies governed by the law of non-member countries and set up in legal forms comparable to companies to which Directive 68/151/EEC applies; whereas for these branches it is necessary to apply certain provisions different from those that apply to the branches of companies governed by the law of other Member States since the Directives referred to above do not apply to companies from non-member countries; Whereas this Directive in no way affects the disclosure requirements for branches under other provisions of, for example, employment law on workers' rights to information and tax law, or for statistical purposes; SECTION I Branches of companies from other Member States Article 1 1. Documents and particulars relating to a branch opened in a Member State by a company which is governed by the law of another Member State and to which Directive 68/151/EEC applies shall be disclosed pursuant to the law of the Member State of the branch, in accordance with Article 3 of that Directive. 2. Where disclosure requirements in respect of the branch differ from those in respect of the company, the branch's disclosure requirements shall take precedence with regard to transactions carried out with the branch. Article 2 1. The compulsory disclosure provided for in Article 1 shall cover the following documents and particulars only: (a) the address of the branch; (b) the activities of the branch; (c) the register in which the company file mentioned in Article 3 of Council Directive 68/151/EEC is kept, together with the registration number in that register; (d) the name and legal form of the company and the name of the branch if that is different from the name of the company; (e) the appointment, termination of office and particulars of the persons who are authorized to represent the company in dealings with third parties and in legal proceedings; - as a company organ constituted pursuant to law or as members of any such organ, in accordance with the disclosure by the company as provided for in Article 2 (1) (d) of Directive 68/151/EEC, - as permanent representatives of the company for the activities of the branch, with an indication of the extent of their powers; (f) the winding-up of the company, the appointment of liquidators, particulars concerning them and their powers and the termination of the liquidation in accordance with disclosure by the company as provided for in Article 2 (1) (h), (j) and (k) of Directive 68/151/EEC, - insolvency proceedings, arrangements, compositions, or any analogous proceedings to which the company is subject; (g) the accounting documents in accordance with Article 3; (h) the closure of the branch. 2. The Member State in which the branch has been opened may provide for the disclosure, as referred to in Article 1, of (a) the signature of the persons referred to in paragraph 1 (e) and (f) of this Article; (b) the instruments of constitution and the memorandum and articles of association if they are contained in a separate instrument in accordance with Article 2 (1) (a), (b) and (c) of Directive 68/151/EEC, together with amendments to those documents; (c) an attestation from the register referred to in paragraph 1 (c) of this Article relating to the existence of the company; (d) an indication of the securities on the company's property situated in that Member State, provided such disclosure relates to the validity of those securities. Article 3 The compulsory disclosure provided for by Article 2 (1) (g) shall be limited to the accounting documents of the company as drawn up, audited and disclosed pursuant to the law of the Member State by which the company is governed in accordance with Directives 78/660/EEC, 83/349/EEC and 84/253/EEC. Article 4 The Member State in which the branch has been opened may stipulate that the documents referred to in Article 2 (2) (b) and Article 3 must be published in another official language of the Community and that the translation of such documents must be certified. Article 5 Where a company has opened more than one branch in a Member State, the disclosure referred to in Article 2 (2) (b) and Article 3 may be made in the register of the branch of the company's choice. In this case, compulsory disclosure by the other branches shall cover the particulars of the branch register of which disclosure was made, together with the number of that branch in that register. Article 6 The Member States shall prescribe that letters and order forms used by a branch shall state, in addition to the information prescribed by Article 4 of Directive 68/151/EEC, the register in which the file in respect of the branch is kept together with the number of the branch in that register. SECTION II Branches of companies from third countries Article 7 1. Documents and particulars concerning a branch opened in a Member State by a company which is not governed by the law of a Member State but which is of a legal form comparable with the types of company to which Directive 68/151/EEC applies shall be disclosed in accordance with the law of the Member State of the branch as laid down in Article 3 of that Directive. 2. Article 1 (2) shall apply. Article 8 The compulsory disclosure provided for in Article 7 shall cover at least the following documents and particulars: (a) the address of the branch; (b) the activities of the branch; (c) the law of the State by which the company is governed; (d) where that law so provides, the register in which the company is entered and the registration number of the company in that register; (e) the instruments of constitution, and memorandum and articles of association if they are contained in a separate instrument, with all amendments to these documents; (f) the legal form of the company, its principal place of business and its object and, at least annually, the amount of subscribed capital if these particulars are not given in the documents referred to in subparagraph (e); (g) the name of the company and the name of the branch if that is different from the name of the company; (h) the appointment, termination of office and particulars of the persons who are authorized to represent the company in dealings with third parties and in legal proceedings: - as a company organ constituted pursuant to law or as members of any such organ, - as permanent representatives of the company for the activities of the branch. The extent of the powers of the persons authorized to represent the company must be stated, together with whether they may do so alone or must act jointly; (i) - the winding-up of the company and the appointment of liquidators, particulars concerning them and their powers and the termination of the liquidation; - insolvency proceedings, arrangements, compositions or any analogous proceedings to which the company is subject; (j) the accounting documents in accordance with Article 7; (k) the closure of the branch. Article 9 1. The compulsory disclosure provided for by Article 8 (1) (j) shall apply to the accounting documents of the company as drawn up, audited and disclosed pursuant to the law of the State which governs the company. Where they are not drawn up in accordance with or in a manner equivalent to Directives 78/660/EEC and 83/349/EEC, Member States may require that accounting documents relating to the activities of the branch be drawn up and disclosed. 2. Articles 4 and 5 shall apply. Article 10 The Member States shall prescribe that letters and order forms used by a branch state the register in which the file in respect of the branch is kept together with the number of the branch in that register. Where the law of the State by which the company is governed requires entry in a register, the register in which the company is entered, and the registration number of the company in that register must also be stated. SECTION III Indication of branches in the company's annual report Article 11 The following subparagraph is added to Article 46 (2) of Directive 78/660/EEC: '(e) the existence of branches of the company'. SECTION IV Transitional and final provisions Article 12 The Member States shall provide for appropriate penalties in the event of failure to disclose the matters set out in Articles 1, 2, 3, 7, 8 and 9 and of omission from letters and order forms of the compulsory particulars provided for in Articles 6 and 10. Article 13 Each Member State shall determine who shall carry out the disclosure formalities provided for in this Directive. Article 14 1. Articles 3 and 9 shall not apply to branches opened by credit institutions and financial institutions covered by Directive 89/117/EEC (8). 2. Pending subsequent coordination, the Member States need not apply Articles 3 and 9 to branches opened by insurance companies. Article 15 Article 54 of Directive 78/660/EEC and Article 48 of Directive 83/349/EEC shall be deleted. Article 16 1. Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1992. They shall forthwith inform the Commission thereof. 2. Member States shall stipulate that the provisions referred to in paragraph 1 shall apply from 1 January 1993 and, with regard to accounting documents, shall apply for the first time to annual accounts for the financial year beginning on 1 January 1993 or during 1993. 3. 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 17 The Contact Committee set up pursuant to Article 52 of Directive 78/660/EEC shall also: (a) facilitate, without prejudice to Articles 169 and 170 of the Treaty, the harmonized application of this Directive, through regular meetings dealing, in particular, with practical problems arising in connection with its application; (b) advise the Commission, if necessary, on any additions or amendments to this Directive. Article 18 This Directive is addressed to the Member States.

31989L0665

1989

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 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 Community Directives on public procurement, in particular Council Directive 71/305/EEC of 26 July 1971 concerning the coordination of procedures for the award of public works contracts (4), as last amended by Directive 89/440/EEC (5), and Council Directive 77/62/EEC of 21 December 1976 coordinating procedures for the award of public supply contracts (6), as last amended by Directive 88/295/EEC (7), do not contain any specific provisions ensuring their effective application; Whereas the existing arrangements at both national and Community levels for ensuring their application are not always adequate to ensure compliance with the relevant Community provisions particularly at a stage when infringements can be corrected; Whereas the opening-up of public procurement to Community competition necessitates a substantial increase in the guarantees of transparency and non-discrimination; whereas, for it to have tangible effects, effective and rapid remedies must be available in the case of infringements of Community law in the field of public procurement or national rules implementing that law; Whereas in certain Member States the absence of effective remedies or inadequacy of existing remedies deter Community undertakings from submitting tenders in the Member State in which the contracting authority is established; whereas, therefore, the Member States concerned must remedy this situation; Whereas, since procedures for the award of public contracts are of such short duration, competent review bodies must, among other things, be authorized to take interim measures aimed at suspending such a procedure or the implementation of any decisions which may be taken by the contracting authority; whereas the short duration of the procedures means that the aforementioned infringements need to be dealt with urgently; Whereas it is necessary to ensure that adequate procedures exist in all the Member States to permit the setting aside of decisions taken unlawfully and compensation of persons harmed by an infringement; Whereas, when undertakings do not seek review, certain infringements may not be corrected unless a specific mechanism is put in place; Whereas, accordingly, the Commission, when it considers that a clear and manifest infringement has been committed during a contract award procedure, should be able to bring it to the attention of the competent authorities of the Member State and of the contracting authority concerned so that appropriate steps are taken for the rapid correction of any alleged infringement; Whereas the application in practice of the provisions of this Directive should be re-examined within a period of four years of its implementation on the basis of information to be supplied by the Member States concerning the functioning of the national review procedures, Article 1 1. The Member States shall take the measures necessary to ensure that, as regards contract award procedures falling withing the scope of Directives 71/305/EEC and 77/62/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 national rules implementing that law. 2. Member States shall ensure that there is no discrimination between undertakings claiming injury in the context of a procedure for the award of a contract as a result of the distinction made by this Directive between national rules implementing Community law and other national rules. 3. The Member States shall ensure that the review procedures are available, under detailed rules which the Member States may establish, at least to any person having or having had an interest in obtaining a particular public supply or public works contract and who has been or risks being harmed by an alleged infringement. In particular, the Member States may require that the person seeking the review must have previously notified the contracting authority of the alleged infringement and of his intention to seek review. Article 2 1. The Member States shall ensure that the measures taken concerning the review procedures specified in Article 1 include provision for the powers to: (a) take, at the earliest opportunity and by way of interlocutory procedures, interim measures with the aim of correcting the alleged infringement or preventing further damage to the interests concerned, including measures to suspend or to ensure the suspension of the procedure for the award of a public contract or the implementation of any decision taken by the contracting authority; (b) either set aside or ensure the setting aside of decisions taken unlawfully, including the removal of discriminatory technical, economic or financial specifications in the invitation to tender, the contract documents or in any other document relating to the contract award procedure; (c) award damages to persons harmed by an infringement. 2. The powers specified in paragraph 1 may be conferred on separate bodies responsible for different aspects of the review procedure. 3. Review procedures need not in themselves have an automatic suspensive effect on the contract award procedures to which they relate. 4. The Member States may provide that when considering whether to order interim measures the body responsible may take into account the probable consequences of the measures for all interests likely to be harmed, as well as the public interest, and may decide not to grant such measures where their negative consequences could exceed their benefits. A decision not to grant interim measures shall not prejudice any other claim of the person seeking these measures. 5. The Member States may provide that where damages are claimed on the grounds that a decision was taken unlawfully, the contested decision must first be set aside by a body having the necessary powers. 6. The effects of the exercise of the powers referred to in paragraph 1 on a contract concluded subsequent to its award shall be determined by national law. Furthermore, except where a decision must be set aside prior to the award of damages, a Member State may provide that, after the conclusion of a contract following its award, the powers of the body responsible for the review procedures shall be limited to awarding damages to any person harmed by an infringement. 7. The Member States shall ensure that decisions taken by bodies responsible for review procedures can be effectively enforced. 8. Where bodies responsible for review procedures are not judicial in character, written reasons for their decisions shall always be given. Furthermore, in such a case, provision must be made to guarantee procedures whereby any allegedly illegal measure taken by the review body or any alleged defect in the exercise of the powers conferred on it can be the subject of judicial review or review by another body which is a court or tribunal within the meaning of Article 177 of the EEC Treaty and independent of both the contracting authority and the review body. The members of such an independent body shall be appointed and leave office under the same conditions as members of the judiciary as regards the authority responsible for their appointment, their period of office, and their removal. At least the President of this independent body shall have the same legal and professional qualifications as members of the judiciary. The independent body shall take its decisions following a procedure in which both sides are heard, and these decisions shall, by means determined by each Member State, be legally binding. Article 3 1. The Commission may invoke the procedure for which this Article provides when, prior to a contract being concluded, it considers that a clear and manifest infringement of Community provisions in the field of public procurement has been committed during a contract award procedure falling within the scope of Directives 71/305/EEC and 77/62/EEC. 2. The Commission shall notify the Member State and the contracting authority concerned of the reasons which have led it to conclude that a clear and manifest infringement has been committed and request its correction. 3. Within 21 days of receipt of the notification referred to in paragraph 2, the Member State concerned shall communicate to the Commission: (a) its confirmation that the infringement has been corrected; or (b) a reasoned submission as to why no correction has been made; or (c) a notice to the effect that the contract award procedure has been suspended either by the contracting authority on its own initiative or on the basis of the powers specified in Article 2 (1) (a). 4. A reasoned submission in accordance with paragraph 3 (b) may rely among other matters on the fact that the alleged infringement is already the subject of judicial or other review proceedings or of a review as referred to in Article 2 (8). In such a case, the Member State shall inform the Commission of the result of those proceedings as soon as it becomes known. 5. Where notice has been given that a contract award procedure has been suspended in accordance with paragraph 3 (c), the Member State shall notify the Commission when the suspension is lifted or another contract procedure relating in whole or in part to the same subject matter is begun. That notification shall confirm that the alleged infringement has been corrected or include a reasoned submission as to why no correction has been made. Article 4 1. Not later than four years after the implementation of this Directive, the Commission, in consultation with the Advisory Committee for Public Contracts, shall review the manner in which the provisions of this Directive have been implemented and, if necessary, make proposals for amendments. 2. By 1 March each year the Member States shall communicate to the Commission information on the operation of their national review procedures during the preceding calendar year. The nature of the information shall be determined by the Commission in consultation with the Advisory Committee for Public Contracts. Article 5 Member States shall bring into force, before 1 December 1991, the measures necessary to comply with this Directive. They shall communicate to the Commission the texts of the main national laws, regulations and administrative provisions which they adopt in the field governed by this Directive. Article 6 This Directive is addressed to the Member States.

31989L0680

1989

Council Directive 89/680/EEC of 21 December 1989 amending directive 77/536/EEC on the approximation of the laws of the member states relating to the roll-over protection structures of wheeled agricultural or forestry tractors 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 necessary to adopt measures 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 Article 9 of Directive 77/536/EEC (4), as last amended by Directive 87/354/EEC (5), limits the scope of the said Directive to wheeled agricultural or forestry tractors with a mass of between 1,5 and 4,5 tonnes; whereas an increase of 1,5 tonnes in the maximum mass as laid down at present would not entail any major disadvantages from the standpoint of safety on the roads and safety at work on the land; Whereas the roll-over protection structures of tractors with a mass of between 4,5 and 6 tonnes can be treated in the same way as those of tractors with a mass of between 1,5 and 4,5 tonnes and hence can be accorded the benefit of the same rules, Article 1 In the first line of the fourth indent of Article 9 of Directive 77/536/EEC, 'mass between 1,5 and 4,5 tonnes' is replaced by 'mass between 1,5 and 6 tonnes'. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 12 months from 3 January 1990. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31989L0681

1989

Council Directive 89/681/EEC of 21 December 1989 amending directive 87/402/EEC on roll-over protection structures mounted in front of the driver's seat on narrow-track wheeled agricultural and forestry tractors 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 necessary to adopt measures 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 Article 12 of Directive 87/402/EEC (4) lays down that the said Directive shall be supplemented by provisions introducing additional impact tests into the dynamic test procedure; Whereas, since provision is already made for an additional test in the case of the static test procedure, it is necessary also in that of the dynamic test procedure to provide for an additional test - which more accurately reflects the situation in the event of tractor roll-over - in order that these two test procedures may be rendered equivalent and the present imbalance between them eliminated; Whereas, in respect of the reliability of the parameters and calculations, the results of the practical experiments carried out on rear-mounted structures may be transposed to the same type of structure, but mounted on the front, OJ N° C 256, 9. 10. 1989, p. 76. Article 1 Directive 87/402/EEC is hereby amended as follows: 1. in Annex IV-A, point 1.6 is replaced by the following: '1.6. Additional tests '1.6.1. If cracks or tears which cannot be considered negligible appear during an impact test, a second, similar test, but with a height of fall of: Hm = 10 × 12 + 4a Hm = H 10 × 12 + 4a 1 + 2a shall be performed immediately after the impact tests causing these tears or cracks to appear, ''a'' being the ratio of the permanent deformation to the elastic deformation (a = Dp/De) as measured at the point of impact. The additional permanent deformation due to the second impact must not exceed 30 % of the permanent deformation due to the first impact. In order to be able to carry out the additional test, it is necessary to measure the elastic deformation during all of the impact tests. '1.6.2. If, during a crushing test, significant cracks or tears appear, a second, similar, crushing test, but with a force equal to 1,2 Fv, shall be performed immediately after the crushing test which caused these tears or cracks to appear.'; 2. in Annex VI, the following point is added: '7.3. Indication and results of any additional dynamic test'. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 12 months from 3 January 1990. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31989L0667

1989

Twelfth Council Company Law Directive 89/667/EEC of 21 December 1989 on single-member private limited-liability companies 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 certain safeguards which, for the protection of the interests of members and others, are required by Member States of companies and firms within the meaning of the second paragraph of Article 58 of the Treaty should be coordinated with a view to making such safeguards equivalent throughout the Community; Whereas, in this field, Directives 68/151/EEC (4) and 78/660/EEC (5), as last amended by the Act of Accession of Spain and Portugal, and Directive 83/349/EEC (6), as amended by the Act of Accession of Spain and Portugal, on disclosure, the validity of commitments, nullity, annual accounts and consolidated accounts, apply to all share capital companies; whereas Directives 77/91/EEC (7) and 78/855/EEC (8), as last amended by the Act of Accession of Spain and Portugal, and Directive 82/891/EEC (9) on formation and capital, mergers and divisions apply only to public limited-liability companies; Whereas the small and medium-sized enterprises (SME) action programme (10) was approved by the Council in its Resolution of 3 November 1986; Whereas reforms in the legislation of certain Member States in the last few years, permitting single-member private limited-liability companies, have created divergences between the laws of the Member States; ¹ ¹ OJ No C 291, 20. 11. 1989, p. 53. ¹ ¹ ¹ ¹ ¹ ¹ ¹ Whereas it is important to provide a legal instrument allowing the limitation of liability of the individual entrepreneur throughout the Community, without prejudice to the laws of the Member States which, in exceptional circumstances, require that entrepreneur to be liable for the obligations of his undertaking; Whereas a private limited-liability company may be a single-member company from the time of its formation, or may become one because its shares have come to be held by a single shareholder; whereas, pending the coordination of national provisions on the laws relating to groups, Member States may lay down certain special provisions and penalties for cases where a natural person is the sole member of several companies or where a single-member company or any other legal person is the sole member of a company; whereas the sole aim of this provision is to take account of the differences which currently exist in certain national laws; whereas, for that purpose, Member States may in specific cases lay down restrictions on the use of single-member companies or remove the limits on the liabilities of sole members; whereas Member States are free to lay down rules to cover the risks that single-member companies may present as a consequence of having single members, particularly to ensure that the subscribed capital is paid; Whereas the fact that all the shares have come to be held by a single shareholder and the identity of the single member must be disclosed by an entry in a register accessible to the public; Whereas decisions taken by the sole member in his capacity as general meeting must be recorded in writing; Whereas contracts between a sole member and his company as represented by him must likewise be recorded in writing, insofar as such contracts do not relate to current operations concluded under normal conditions, Article 1 The coordination measures prescribed by this Directive shall apply to the laws, regulations and administrative provisions of the Member States relating to the following types of company: - in Germany: Gesellschaft mit beschraenkter Haftung, - in Belgium: Société privée à responsabilité limitée/de besloten vennootschap met beperkte aansprakelijkheid, - in Denmark: Anpartsselskaber, - in Spain: Sociedad de responsabilidad limitada, - in France: Société à responsabilité limitée, - in Greece: Etaireia periorismenis efthynis, - in Ireland: Private company limited by shares or by guarantee, - in Italy: Società a responsabilità limitata, - in Luxembourg: Société à responsabilité limitée, - in the Netherlands: Besloten vennootschap met beperkte aan- sprakelijkheid, - in Portugal: Sociedade por quotas, - in the United Kingdom: Private company limited by shares or by guarantee. Article 2 1. A company may have a sole member when it is formed and also when all its shares come to be held by a single person (single-member company). 2. Member States may, pending coordination of national laws relating to groups, lay down special provisions or sanctions for cases where: (a) a natural person is the sole member of several companies; (b) a single-member company or any other legal person is the sole member of a company. Article 3 Where a company becomes a single-member company because all its shares come to be held by a single person, that fact, together with the identity of the sole member, must either be recorded in the file or entered in the register within the meaning of Article 3 (1) and (2) of Directive 68/151/EEC or be entered in a register kept by the company and accessible to the public. Article 4 1. The sole member shall exercise the powers of the general meeting of the company. 2. Decisions taken by the sole member in the field referred to in paragraph 1 shall be recorded in minutes or drawn up in writing. Article 5 1. Contracts between the sole member and his company as represented by him shall be recorded in minutes or drawn up in writing. 2. Member States need not apply paragraph 1 to current operations concluded under normal conditions. Article 6 Where a Member State allows single-member companies as defined by Article 2 (1) in the case of public limited companies as well, this Directive shall apply. Article 7 A Member State need not allow the formation of single-member companies where its legislation provides that an individual entrepreneur may set up an undertaking the liability of which is limited to a sum devoted to a stated activity, on condition that safeguards are laid down for such undertakings which are equivalent to those imposed by this Directive or by any other Community provisions applicable to the companies referred to in Article 1. Article 8 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1992. They shall inform the Commission thereof. 2. Member States may provide that, in the case of companies already in existence on 1 January 1992, this Directive shall not apply until 1 January 1993. 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. Article 9 This Directive is addressed to the Member States.

31989L0677

1989

Council Directive 89/677/EEC of 21 December 1989 amending for the eighth time Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the member states relating to restrictions on the marketing and use of certain dangerous substances and preparations 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 for the progressive establishment of the internal market over the period up to 31 December 1992 have to be adopted; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is guaranteed; Whereas, despite the ban on the marketing of certain ornamental objects intended to produce effects of light and comprising glass receptacles containing dangerous liquids as defined by Directive 67/548/EEC (4), as last amended by Directive 86/431/EEC (5), objects presenting the same hazards are still being marketed for use in games for one or more participants, sometimes with an ornamental function; Whereas there should be a review of the content (0,01 % by weight - 100 ppm) of PCB/PCT in preparations, including waste oils; whereas, in Council Directive 87/101/EEC of 22 December 1986 amending Directive 75/439/EEC on the disposal of waste oils (6), this content was set at 0,005 % by weight; Whereas benzene (CAS N° 71-34-2) is a toxic substance likely to affect the central nervous and hematopoietic systems and to cause cancer and in particular leukaemia; whereas this substance is classified as carcinogen category I in Directive 67/548/EEC; whereas ILO (International OJ N° C 256, 9. 10. 1989, p. 70. OJ N° C 337, 31. 12. 1987, p. 7. Labour Organization) Convention 136 and ILO Recommendation 144 lay down provisions on protection against hazards arising from benzene; Whereas the following substances: 2-naphthylamine (CAS N° 91-59-8), 4-nitrodiphenyl (CAS N° 92-93-3), 4-aminodiphenyl (CAS N° 92-67-1) and benzidine (CAS N° 92-87-5) may cause cancer and in particular cancer of the urinary system; whereas these substances are classified as carcinogens category I in Directive 67/548/EEC; whereas although, within the Community, they are now produced only in minimal, supervised quantities intended exclusively for research, they may nevertheless be present in the form of impurities in other substances or preparations; Whereas, apart from the specific measures applying solely to workplaces, the laying down of a maximum concentration limit and a limit on the use of these substances as such or as constituents of preparations would help to present the incidence of cancer at work and protect consumers; Whereas lead compounds in general, and in particular lead salts that are readily soluble in the stomach, are dangerous to health; whereas compounds of this type are still occasionally used as pigment for certain decorative paints; whereas their use in such cases should be regulated; whereas ILO Convention 13 regulates the use of white lead in painting; Whereas certain anti-fouling preparations applied as protective coatings to boat hulls and/or underwater equipment have harmful effects on living aquatic organisms as a result of the use of certain chemical compounds and in particular arsenic, mercury and tin compounds; whereas, in order better to protect the environment, the use of such compounds in preparations of this type should be regulated; Whereas not only di-ì-oxo-di-n-butylstanniohydroxy- borane (C8H19BO3Sn, CAS N° 75113-37-0) but also its decomposition/degradation products are substances that are dangerous to man and to the environment, and in particular the aquatic environment; whereas the use of those substances should be regulated; Whereas limitations on use or marketing already adopted by certain Member States in respect of the substances referred to above or of preparations containing them have a direct incidence on the establishment and functioning of the internal market; whereas it is therefore necessary to approximate the legislative provisions of the Member States in this field, and consequently to amend Annex I to Directive 76/769/EEC (1), as last amended by Directive 85/610/EEC (2); Whereas present Community legislation concerning the possible adoption by Member States of more stringent restrictions on the use of the substances and preparations in question at the workplace is unaffected by this Directive, Article 1 Annex I to Directive 76/769/EEC is hereby amended as follows: 1. in point 1 of the left-hand column, '0,01 %' appearing in the third indent is replaced by '0,005 %'; 2. point 3 is replaced by the following: '3. '3. Liquid substances or preparations, which are regarded as dangerous according to the definitions in Article 2 (2) and the criteria in Annex VI, Part II.D 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 86/431/EEC (2). May not be used in: - ornamental objects intended to produce light or colour effects by means of different phases, for example in ornamental lamps and ashtrays, - tricks, jokes, - games for one or more participants, or any object intended to be used as such, even with ornamental aspects. (1) OJ N° 196, 16. 8. 1967, p. 1. (2) OJ N° L 247, 1. 9. 1986, p. 1.'; 3. the following is added to point 5 (benzene) in the right-hand column: 'May not be used in concentrations equal to, or greater than, 0,1 % by mass in substances or preparations placed on the market. However, this provision shall not apply to: (a) motor fuels which are covered by Directive 85/210/EEC; (b) substances and preparations for use in industrial processes not allowing for the emission of benzene in quantities in excess of those laid down in existing legislation; (c) waste covered by Directives 75/442/EEC (1) and 78/319/EEC (2). (1) OJ N° L 194, 25. 7. 1975, p. 39. (2) OJ N° L 84, 31. 3. 1978, p. 43.'; 4. the following points are added: '13. '13. 2-naphthylamine CAS N° 91-59-8 and its salts May not be used in concentrations equal to or greater than 0,1 % by weight in substances and preparations placed on the market. '14. '15. Benzidine CAS N° 92-87-5 and its salts 4-nitrobiphenyl CAS N° 92-93-3 However, this provision shall not apply to waste containing one or more of these substances and covered by Directives 75/442/EEC and 78/319/EEC. '16. 4-aminobiphenyl CAS N° 92-67-1 and its salts Such substances and preparations may not be sold to the general public. Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the packaging of such preparations shall be legible and indelibly marked as follows: ''Restricted to professional users.'' '17. Lead carbons: - neutral anhydrous carbonate PB CO3 CAS N° 598-63-0 - lead hydrocarbonate 2 Pb CO3 Pb(OH)2 CAS N° 1319-46-6 May not be used as substances and constituents of preparations intended for use as paints, except for the restoration and maintenance of works of art and historic buildings and their interiors, where Member States wish to authorize this on their territory, in accordance with the provisions of ILO Convention 13 on the use of white lead in paint. '18. Lead sulphates PBSO4 (1 : 1) CAS N° 7446-14-2 Pbx SO4 CAS N° 15739-80-7 May not be used as substances and constituents of preparations intended for use as paints, except for the restoration and maintenance of works of art and historic buildings and their interiors, where Member States wish to authorize this on their territory, in accordance with the provisions of ILO Convention 13 on the use of sulphates of lead in paint. '19. Mercury compound May not be used as substances and constituents of preparations intended for use: (a) to prevent the fouling by micro- organisms, plants or animals of: - the hulls of boats, - cages, floats, nets and any other appliances or equipment used for fish or shellfish farming, - any totally or partly submerged appliances or equipment; (b) in the preservation of wood; (c) in the impregnation of heavy-duty industrial textiles and yarn intended for their manufacture; (d) in the treatment of industrial waters, irrespective of their use. '20. Arsenic compounds 1. May not be used as substances and constituents of preparations intended for use: (a) to prevent the fouling by micro- organisms, plants or animals of: - the hulls of boats, - cages, floats, nets and any other appliances or equipment used for fish or shellfish farming, - any totally or partly submerged appliances or equipment; (b) in the preservation of wood. In this case, the ban does not apply to solutions of inorganic salts of the CCA (copper - chromium - arsenic) type employed in industrial installations using vacuum or pressure to impregnate wood. In addition, Member States may authorize on their territory the use of preparations of the DFA (dinitrophenol - fluoride - arsenic) type for the retreatment in situ of wooden poles already in place and supporting overhead cables. Such preparations must be employed by professionals using vacuum or pressure. 2. May not be used as substances and constituents of preparations intended for use in the treatment of industrial waters, irrespective of their use. '21. Organostannic compounds 1. May not be used as substances and constituents of preparations intended for use to prevent the fouling by micro- organisms, plants or animals of: (a) the hulls of boats of an overall length, as defined by ISO 8666, of less than 25 metres; (b) cages, floats, nets and any other appliances or equipment used for fish or shellfish farming; (c) any totally or partly submerged appliances or equipment. Such substances and preparations - may be placed on the market only in packagings of a capacity equal to or greater than 20 litres, - may not be sold to the general public but only to professional users. Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the packaging of such preparations shall be legible and indelibly marked as follows: ''Not to be used on boats of an overall length of less than 25 metres or on any appliances or equipment used in fish or shellfish farming.'' ''Restricted to professional users.'' 2. May not be used as substances and constituents of preparations intended for use in the treatment of industrial waters, irrespective of their use. '22. di-ì-oxo-di-n- butylstanniohydroxyborane (C8H19BO3Sn, CAS N° 75113-37-0) (DBB) Shall be prohibited in a concentration equal to or greater than 0,1 % in substances and constituents of preparations placed on the market. However, this provision shall not apply to this substance (DBB) or preparations containing it if these are intended solely for conversion into finished products, among which this substance will no longer feature in a concentration equal to or greater than 0,1 %.' Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 18 months after the date of its adoption. They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission not later than 18 months after the adoption of this Directive the text 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.

31989L0686

1989

Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment 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 necessary to adopt measures 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 guaranteed; Whereas various Member States have, over recent years, adopted provisions covering numerous items of personal protective equipment with a view in particular to safeguarding public health, improving safety at work and ensuring user protection; Whereas these national provisions are often very detailed as regards the requirements relating to the design, manufacture, quality level, testing and certification of personal protective equipment with a view to the protection of individuals against injury and illness; Whereas, in particular, the national provisions relating to safety at work make the use of personal protective equipment compulsory; whereas many requirements oblige employers to make appropriate personal protective equipment available to their staff in the absence or inadequacy of priority public protection measures; Whereas national provisions relating to personal protective equipment differ significantly from one Member State to another; whereas they may thus constitute a barrier to trade with direct consequences for the creation and operation of the common market; Whereas it is necessary to harmonize these different national provisions in order to ensure the free movement of these OJ N° C 304, 4. 12. 1989, p. 29. products, without in any way reducing the valid levels of protection already required in the Member States, and to provide for any necessary increase therein; Whereas the provisions governing the design and manufacture of personal protective equipment laid down in this Directive which are fundamental, in particular, to attempts to ensure a safer working environment are without prejudice to provisions relating to the use of such equipment and the organization of the health and safety of workers at the workplace; Whereas this Directive defines only the basic requirements to be satisfied by personal protective equipment; whereas, in order to facilitate proof of conformity with those basic requirements, it is essential that harmonized European standards be available relating, in particular, to the design and manufacture of, and the specifications and test methods applicable to, personal protective equipment, since compliance therewith confers on these products a presumption of conformity with the abovementioned basic requirements; whereas such harmonized European standards are drawn up by private bodies and must retain the status of non-mandatory texts; whereas, to this end, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are the competent bodies which have been authorized to adopt harmonized standards in accordance with the general guidelines governing cooperation between the Commission and those two institutions ratified on 13 November 1984; whereas, for the purposes of this Directive, a harmonized standard is a text containing technical specifications (a European standard or a harmonization document) which has been adopted by one or both of the abovementioned bodies at the instigation of 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), as amended by Directive 88/182/EEC (5), and pursuant to the abovementioned general guidelines; Whereas, pending the adoption of harmonized standards, which will be very numerous because of the broad scope of application and the preparation of which within the deadline set for the creation of the internal market will involve a great deal of work, it would be advisable to maintain, on a transitional basis and subject to the requirements of the Treaty, the status quo as regards conformity with existing national standards for personal protective equipment not covered by a harmonized standard at the date of adoption of this Directive; Whereas, given the general and horizontal nature of the role played by the Standing Committee set up pursuant to Article 5 of Directive 83/189/EEC in Community standardization policy and, more particularly, its part in the preparation of standardization applications and the operation of the existing European standardization agreements, this Standing Committee is especially suited to the task of assisting the Commission in monitoring the conformity of harmonized standards throughout the Community; Whereas compliance with these technical requirements must be monitored in order to ensure adequate user and third-party protection; whereas existing monitoring procedures may differ appreciably from one Member State to another; whereas, in order to avoid numerous checks which merely impede the free movement of personal protective equipment, provision should be made for the mutual recognition of inspections conducted by the Member States; whereas, in order to facilitate such recognition, it is necessary, in particular, to lay down harmonized Community procedures and to harmonize the criteria to be taken into account in selecting the bodies responsible for examination, monitoring and verification; Whereas the legislative framework should be improved so that both sides of industry will make an effective and appropriate contribution to the process of standardization, CHAPTER I SCOPE, PLACING ON THE MARKET AND FREE MOVEMENT Article 1 1. This Directive applies to personal protective equipment, hereinafter referred to as 'PPE'. It lays down the conditions governing its placing on the market and free movement within the Community and the basic safety requirements which PPE must satisfy in order to ensure the health protection and safety of users. 2. For the purposes of this Directive, PPE shall mean any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards. PPE shall also cover: (a) a unit constituted by several devices or appliances which have been integrally combined by the manufacturer for the protection of an individual against one or more potentially simultaneous risks; (b) a protective device or appliance combined, separably or inseparably, with personal non-protective equipment worn or held by an individual for the execution of a specific activity; (c) interchangeable PPE components which are essential to its satisfactory functioning and used exclusively for such equipment. 3. Any system placed on the market in conjunction with PPE for its connection to another external, additional device shall be regarded as an integral part of that equipment even if the system is not intended to be worn or held permanently by the user for the entire period of risk exposure. 4. This Directive does not apply to: - PPE covered by another directive designed to achieve the same objectives as this Directive with regard to placing on the market, free movement of goods and safety, - the PPE classes specified in the list of excluded products in Annex I, independently of the reason for exclusion mentioned in the first indent. Article 2 1. Member States shall take all appropriate measures to ensure that the PPE referred to in Article 1 may be placed on the market and brought into service only if it preserves the health and ensures the safety of users without prejudice to the health or safety of other individuals, domestic animals or goods, when properly maintained and used for its intended purpose. 2. This Directive shall be without prejudice to the right of Member States to lay down - in conformity with the Treaty - any requirements which they consider necessary to ensure user protection, provided that this does not give rise to modifications to PPE which could result in its non-conformity with the provisions of this Directive. 3. Member States shall not prevent the presentation at trade fairs, exhibitions and the like of PPE which is not in conformity with the provisions of this Directive, provided that an appropriate notice is displayed drawing attention to this fact and the prohibition on its acquisition and/or use for any purpose whatsoever until it has been brought into conformity by the manufacturer or his representative established in the Community. Article 3 The PPE referred to in Article 1 must satisfy the basic health and safety requirements laid down in Annex II. Article 4 1. Member States shall not prohibit, restrict or hinder the placing on the market of PPE or PPE components which satisfy the provisions of this Directive and which bear the EC mark. 2. Member States shall not prohibit, restrict or impede the placing on the market of PPE components which do not bear the EC mark, and which are intended to be incorporated in PPE, provided that they are not essential to its satisfactory functioning. Article 5 1. Member States shall regard as in conformity with the basic requirements referred to in Article 3 the PPE referred to in Article 8 (3) bearing the EC mark with respect to which the manufacturer is able to produce, on demand, the declaration of conformity referred to in Article 12. 2. Member States shall presume that the PPE referred to in Article 8 (2) satisfies the basic requirements referred to in Article 3 if it bears the EC mark with respect to which the manufacturer is able to produce, on demand, not only the declaration referred to in Article 12 but also the certificate issued by the body of which notification has been given in accordance with Article 9 attesting to their conformity to the relevant national standards, transposing the harmonized standards, assessed at the EC type examination level in accordance with the first indent of Article 10 (4) (a) and (b). Where a manufacturer has not applied or has only partly applied the harmonized standards or where there are no such standards the certificate issued by the body of which notification has been given must state the conformity to the basic requirements in accordance with the second indent of Article 10 (4) (a) and (b). 3. The PPE referred to in Article 8 (2) for which harmonized standards are not available may continue on a transitional basis, until 31 December 1992 at the latest, to be subject to national arrangements already in force on the date of adoption of this Directive, provided that such arrangements are compatible with the provisions of the Treaty. 4. The Commission shall publish the references of the harmonized standards in the Official Journal of the European Communities. Member States shall publish the references of the national standards transposing the harmonized standards. 5. Member States shall ensure that by 30 June 1991 appropriate steps are taken to enable both sides of industry to have an influence at national level on the process of formulating the harmonized standards and keeping them under review. Article 6 1. Should a Member State or the Commission consider that the harmonized standards referred to in Article 5 do not completely satisfy the relevant basic requirements referred to in Article 3, the Commission or the Member State concerned shall refer the matter to the committee created pursuant to Directive 83/189/EEC (1), setting out its reasons. The committee shall deliver an opinion without delay. In the light of the committee's opinion, the Commission shall notify Member States of whether or not it is necessary to withdraw the standards concerned from publications made pursuant to Article 5. 2. The Standing Committee set up by Article 6 (2) of Directive 89/392/EEC (2) may be apprised, in accordance with the procedure described below, of any matter to which the implementation and practical application of this Directive give rise. 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 1. If a Member State discovers that PPE bearing the EC mark and used in accordance with its intended purpose could compromise the safety of individuals, domestic animals or property, it shall take all necessary measures to remove that equipment from the market and prohibit the marketing or free movement thereof. The Member State concerned shall immediately inform the Commission of such action, indicating the reasons for its decision and, in particular, stating whether non-conformity is due to: (a) failure to comply with the basic requirements referred to in Article 3; (b) the unsatisfactory application of the standards referred to in Article 5; (c) a shortcoming in the standards referred to in Article 5. 2. The Commission shall initiate discussions with the parties concerned as soon as possible. If, after such consultation, the Commission decides that the action taken was justified, it shall immediately inform the Member State concerned and all the other Member States to that effect. If, after such consultation, the Commission decides that the action taken was not justified, it shall immediately inform the Member State concerned and the manufacturer or his authorized representative established in the Community to that effect. If the decision referred to in paragraph 1 is in response to a shortcoming in the standards, the Commission shall refer the matter to the Committee referred to in Article 6 (1) if the Member State concerned intends to adhere to its decision and shall initiate the procedure referred to in Article 6 (2). 3. If PPE which is not in conformity with the relevant requirements bears the EC mark, the Member State concerned shall take the appropriate measures with regard to those responsible for affixing the mark and shall inform the Commission and the other Member States accordingly. 4. The Commission shall ensure that the Member States are kept informed of the progress and results of the procedure provided for in this Article. CHAPTER II CERTIFICATION PROCEDURES Article 8 1. Before placing a PPE model on the market, the manufacturer or his authorized representative established in the Community shall assemble the technical documentation referred to in Annex III so that this can, if necessary, be submitted to the competent authorities. 2. Prior to the series production of PPE other than those referred to in paragraph 3, the manufacturer or his authorized representative established in the Community shall submit a model for EC type-examination as referred to in Article 10. 3. EC type-examination shall not be required in the case of PPE models of simple design where the designer assumes the user can himself assess the level of protection provided against the minimal risks concerned the effects of which, when they are gradual, can be safely identified by the user in good time. This category shall cover exclusively PPE intended to protect the wearer against: - mechanical action whose effects are superficial (gardening gloves, thimbles, etc.), - cleaning materials of weak action and easily reversible effects (gloves affording protection against diluted detergent solutions, etc.), - risks encountered in the handling of hot components which do not expose the user to a temperature exceeding 50 gC or to dangerous impacts (gloves, aprons for professional use, etc.), - atmospheric agents of a neither exceptional nor extreme nature (headgear, seasonal clothing, footwear, etc.), - minor impacts and vibrations which do not affect vital areas of the body and whose effects cannot cause irreversible lesions (light anti-scalping helmets, gloves, light footwear, etc.), - sunlight (sunglasses). 4. Production of PPE shall be subject: (a) according to the manufacturer's choice, to one of the two procedures referred to in Article 11 in the case of PPE of complex design intended to protect against mortal danger or against dangers that may seriously and irreversibly harm the health, the immediate effects of which the designer assumes the user cannot identify in sufficient time. This category shall cover exclusively: - filtering respiratory devices for protection against solid and liquid aerosols or irritant, dangerous, toxic or radiotoxic gases, - respiratory protection devices providing full insulation from the atmosphere, including those for use in diving, - PPE providing only limited protection against chemical attack or against ionizing radiation, - emergency equipment for use in high-temperature environments the effects of which are comparable to those of an air temperature of 100 gC or more and which may or may not be characterized by the presence of infra-red radiation, flames or the projection of large amounts of molten material, - emergency equipment for use in low-temperature environments the effects of which are comparable to those of an air temperature of 50 gC or less, - PPE to protect against falls from a height, - PPE against electrical risks and dangerous voltages or that used as insulation in high-tension work, - motor cycle helmets and visors; (b) the EC declaration of conformity referred to in Article 12 for all PPE. Article 9 1. Each Member State shall inform the Commission and the other Member States of the approved bodies responsible for the execution of the certification procedures referred to in Article 8. For information purposes, the Commission shall publish in the Official Journal of the European Communities and keep up to date a list giving the names of these bodies and the distinguishing numbers it has assigned to them. 2. Member States shall apply the criteria laid down in Annex V in assessing the bodies to be indicated in such notification. Bodies meeting the assessment criteria laid down in the relevant harmonized standards shall be presumed to fulfil those criteria. 3. A Member State shall withdraw its approval from such a body if it establishes that the latter no longer satisfies the criteria referred to in Annex V. It shall inform the Commission and the other Member States of its action forthwith. EC TYPE-EXAMINATION Article 10 1. EC type-examination is the procedure whereby the approved inspection body establishes and certifies that the PPE model in question satisfies the relevant provisions of this Directive. 2. Application for EC type-examination shall be made by the manufacturer or his authorized representative to a single approved inspection body in respect of the model in question. The authorized representative shall be established in the Community. 3. The application shall comprise: - the name and address of the manufacturer or his authorized representative and of the PPE production plant in question, - the manufacturer's technical file referred to in Annex III. It shall be accompanied by the appropriate number of specimens of the model to be approved. 4. The inspection body of which notification has been given shall conduct the EC type-examination in accordance with the undermentioned procedures: (a) Examination of the manufacturer's technical file - It shall examine the manufacturer's technical file to establish its suitability with respect to the harmonized standards referred to in Article 5. - Where a manufacturer has not applied, or has only partly applied, the harmonized standards or where there are no such standards, the body of which notification has been given must check the suitability of the technical specifications used by the manufacturer with respect to the basic requirements before examining the manufacturer's technical file to establish its suitability with respect to these technical specifications. (b) Examination of the model - When examining the model, the inspection body shall verify that it has been produced in accordance with the manufacturer's technical file and can be used in complete safety for its intended purpose. - It shall conduct the necessary examinations and tests to establish the conformity of the model with the harmonized standards. - Where a manufacturer has not applied or has only partly applied the harmonized standards or where there are no such standards the body of which notification has been given shall conduct the necessary examinations and tests to establish the conformity of the model with the technical specifications used by the manufacturer, subject to their being suitable with respect to these basic requirements. 5. If the model satisfies the relevant provisions, the inspection body shall draw up an EC type-examination certificate and shall notify the applicant to this effect. This certificate shall reproduce the findings of the examination, indicate any conditions attaching to its issue and incorporate the descriptions and drawings necessary for the identification of the approved model. The Commission, the other approved inspection bodies and the other Member States may obtain a copy of the certificate and, in response to a reasoned request, a copy of the manufacturer's technical file and the reports of the examinations and tests conducted. The file shall be held at the disposal of the competent authorities for 10 years following the placing of the PPE on the market. 6. Any inspection body which refuses to issue an EC type-examination certificate shall inform the other approved inspection bodies of this fact. An inspection body withdrawing an EC type-examination certificate shall inform the Member State which approved it, to this effect. That Member State shall then inform the other Member States and the Commission, setting out the reasons for the decision. CHECKING OF PPE MANUFACTURED Article 11 A. 'EC' quality control system for the final product 1. A manufacturer shall take all steps necessary to ensure that the manufacturing process, including the final inspection of PPE and tests, ensures the homogeneity of production and the conformity of PPE with the type described in the EC type-approval certificate and with the relevant basic requirements of this Directive. 2. A body of which notification has been given, chosen by a manufacturer, shall carry out the necessary checks. Those checks shall be carried out at random, normally at intervals of at least one year. 3. An adequate sample of PPE taken by the body of which notification has been given shall be examined and appropriate tests defined in the harmonized standards or necessary to show conformity to the basic requirements of this Directive shall be carried out to check the conformity of PPE. 4. Where a body is not the body that issued the relevant EC type-approval certificate it shall contact the body of which notification has been given in the event of difficulties in connection with the assessment of the conformity of samples. 5. The body of which notification has been given shall provide the manufacturer with a test report. If the report concludes that production is not homogeneous or that the PPE examined do not conform to the type described in the EC type-approval certificate or the relevant basic requirements, the body shall take measures appropriate to the nature of the fault or faults recorded and inform the Member State which gave notification thereof accordingly. 6. The manufacturer must be able to present, on request, the report of the body of which notification has been given. B. System for ensuring EC quality of production by means of monitoring 1. The system (a) Under this procedure the manufacturer submits an application for the approval of his quality-control system to a body of which notification has been given, of his choice. That application shall include: - all the information relating to the category of PPE concerned, including, where appropriate, documentation relating to the model approved, - documentation on the quality-control system, - the undertaking to maintain the obligations arising from the quality-control system and to maintain its adequacy and efficiency. (b) Under the quality-control system, each PPE shall be examined and the appropriate tests referred to in Section A paragraph 3 shall be carried out to check their conformity to the relevant basic requirements of this Directive. The documentation on the quality-control system shall in particular include an adequate description of: - the quality objectives, the organization chart, the responsibilities of executives and their powers in respect of product quality, - the checks and tests which must be carried out after manufacture, - the means to be employed to check the efficient operation of the quality-control system. (c) The body shall assess the quality-control system to determine whether it satisfies the provisions referred to in paragraph 1 (b). It shall assume that quality-control systems applying the relevant harmonized standard satisfy those provisions. The body carrying out audits shall make all necessary objective evaluations of the components of the quality-control system and shall check in particular whether the system ensures conformity of PPE manufactured with the approved model. The decision shall be communicated to the manufacturer. It shall include the conclusions of the check and the reasoned assessment decision. (d) The manufacturer shall inform the body which approved the quality-control system of any plan to alter the quality-control system. The body shall examine the proposed changes and decide whether the altered quality-control system satisfies the relevant provisions. It shall communicate its decision to the manufacturer. The communication shall include the conclusions of the check and the reasoned assessment decision. 2. Supervision (a) The purpose of supervision is to ensure that a manufacturer correctly fulfils the obligations arising from the approved quality-control system. (b) The manufacturer shall authorize the body to have access, for purposes of inspection, to PPE inspection, testing and storage sites and shall provide the body with all requisite information, in particular: - documentation on the quality-control system, - technical documentation, - quality control manuals. (c) The body shall periodically carry out audits to ensure that the manufacturer is maintaining and applying the approved quality-control system and shall provide the manufacturer with a copy of the audit report. (d) In addition, the body may make unannounced visits to the manufacturer. In the course of such visits the body shall provide the manufacturer with a report of the visit and, if appropriate, with an audit report. (e) The manufacturer must be able to present, on request, the report of the body of which notification has been given. EC DECLARATION OF PRODUCTION CONFORMITY Article 12 The EC declaration of conformity is the procedure whereby the manufacturer: 1. draws up a declaration using the form laid down in Annex VI certifying that the PPE placed on the market are in conformity with the provisions of this Directive with a view to its submission to the competent authorities; 2. affixes the EC mark of conformity provided for by Article 13 to each PPE. CHAPTER III EC MARK Article 13 1. The EC mark consists of the letters 'CE' followed by the last two figures of the year in which the mark was affixed and, in the event of the involvement of a notified body having carried out an EC examination of the type referred to in Article 10, its distinguishing number shall be added. The form of the mark to be used is shown in Annex IV. 2. The EC mark shall be affixed to each production PPE and its packaging so as to be visible, legible and indelible throughout the foreseeable useful life of that PPE. 3. Marks or inscriptions which could be confused with the EC mark may not be affixed to PPE. CHAPTER IV FINAL PROVISIONS Article 14 Any decision taken in implementation of this Directive and leading to restrictions on the marketing of PPE shall be accompanied by a detailed explanation of the grounds on which it is based. The interested party shall be notified of the decision without delay and informed of the possibilities for appeal under the legislation in force in the Member State concerned and of the deadlines for lodging such appeals. Article 15 The Commission shall take the necessary steps to ensure that data concerning all the relevant decisions in connection with the management of this Directive are made available. Article 16 1. By 31 December 1991, Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 July 1992. 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 17 This Directive is addressed to the Member States.

31989L0676

1989

Council Directive 89/676/EEC of 21 December 1989 amending Directive 75/106/EEC on the approximation of the laws of the member states relating to the making-up by volume of certain prepackaged liquids 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 75/106/EEC (4), as last amended by Directive 88/316/EEC (5), provides for total harmonization of the range of nominal quantities of certain products in the wine sector; Whereas, in view of developments within the Community in the vatting, bottling and labelling of wine, it is necessary to modify this range; Whereas, in order to permit the use of returnable bottles of volumes not covered by the said Directive, it is necessary to include special rules therein, Article 1 Directive 75/106/EEC is hereby amended as follows: 1. the second subparagraph of Article 1 is replaced by the following: 'This Directive shall not apply to prepackages containing the products listed in Annex III: - point 1 (a), which are vatted, bottled and labelled in volumes not exceeding 0,25 litre and are intended for professional use, - points 2 (a) and 4, which are intended either for consumption on board aircraft, ships and trains or for sale in duty-free shops.'; 2. in Article 5 (3): (a) point (a) is deleted; (b) the indents in point (c) are replaced by the following: '- 0,68 litre, 0,70 litre and 0,98 litre in Spain, until 31 December 1992, '- 0,46 litre and 0,70 litre in Greece, until 31 December 1992.'; 3. Annex III, column I (1) (a) is hereby amended as follows: (a) the following is added: '0,187 (l)-4-8'; (b) '0,187 (for consumption on board aircraft and ships only)', at the end of the range of volumes, is deleted. (c) the following footnote is added: '(1) Value relating only to consumption on board aircraft, ships and trains and to sales in duty-free shops.' Article 2 Member States shall bring into force the laws, regulations and administrative provisions needed to comply with this Directive on 1 July 1990. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31990L0044

1990

Council Directive 90/44/EEC of 22 January 1990 amending Directive 79/373/EEC on the marketing of compound feedingstuffs 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 Directive 79/373/EEC (4), as last amended by Directive 87/235/EEC (5), lays down rules for the marketing of compound feedingstuffs within the Community; Whereas under present Community legislation Member States may, in certain cases, waive the Community rules, particularly as regards labelling and the choice of ingredients; Whereas, with a view to the completion of the internal market, all national derogations liable further to inhibit free movement of compound feedingstuffs or creating unequal conditions of competition should be eliminated; Whereas the most appropriate method of eliminating all present disparities relating to labelling rules is to fix - at Community level - a list of declarations which, in each case, must be given or may be given on a voluntary basis by the person responsible for labelling; Whereas, as regards labelling, the purpose of Directive 79/373/EEC is to ensure that stock farmers are informed objectively and as accurately as possible as to the composition and use of feedingstuffs; whereas it is important to ensure that the accuracy of the declarations made can be officially verified, in accordance with the relevant provisions laid down in the Directive, at all stages of marketing of the feedingstuffs; Whereas the declaration of the ingredients in feedingstuffs constitutes, in certain cases, an important item of information for stock farmers; Whereas the quantitative determination of the ingredients in feedingstuffs for production animals raises at the present time, as regards verification, difficulties, mainly because of the nature of the products used, of the complexity of the mixtures made or the manufacturing methods adopted; Whereas, accordingly, it is appropriate - at this stage - to prefer, at least for feedingstuffs for production animals, a flexible declaration arrangement confined to the indication of the feedingstuff ingredients without stating their quantity; whereas the possibility must also be retained of creating categories making it possible to group under a single name several ingredients; whereas, since categories of ingredients have already been established by Commission Directive 82/475/EEC (6) for compound feedingstuffs intended for pets, similar provisions should be adopted for the other feedingstuffs; Whereas special provisions are needed for the labelling of feedingstuffs for pets to allow for the special character of this kind of feedingstuff; Whereas manufacturers of compound feedingstuffs must be free to provide the stock farmer with information other than that specifically laid down in Directive 79/373/EEC, but provision of such additional information should be made subject to certain conditions or restrictions to ensure fair competition between manufacturers and to ensure that such information is objective; Whereas Directive 79/373/EEC now enables Member States to require that compound feedingstuffs be manufactured on the basis of specified ingredients or be free of certain ingredients; whereas the obstacles resulting from such limitations must be eliminated by adopting, at Community level, a list of ingredients used for the manufacture of compound feedingstuffs and a list of ingredients use of which must be prohibited for health reasons; Whereas the list of ingredients which can be used in feedingstuffs cannot be exhaustive owing to the great diversity of products and by-products which may be used, to the constant development of food technology and to the need not to restrict the choice of manufacturers; whereas it is sufficient to draw up an inventory of the main ingredients normally used in the manufacture of compound feedingstuffs; Whereas that inventory must specify the common names to be used to designate the various ingredients and the descriptions with which they must comply in order to qualify for such names; Whereas the description given of the various ingredients might prove insufficient on its own to distinguish products which are very close but sometimes different in quality; whereas provision should be made for such special cases for the additional possibility of laying down minimum compositional requirements; Whereas the list of ingredients which may be used in the manufacture of compound feedingstuffs is not exhaustive; whereas the Member States are accordingly required to allow compound feedingstuffs marketed within the Community to contain ingredients other than those included on the abovementioned list provided that such products are of sound, genuine and merchantable quality and that they are designated by specific names preventing any confusion with ingredients qualifying for a name established at Community level; Whereas the establishment of the list of the main ingredients normally used and marketed for the preparation of compound feedingstuffs and the establishment of the list of ingredients use of which must be prohibited in the future are measures of a scientific nature; whereas, to facilitate the adoption of such measures, the procedure introducing close cooperation between the Member States and the Commission within the Standing Committee for Feedingstuffs should be followed; Whereas, in order to ensure compliance with the requirements concerning compound feedingstuffs, Member States must provide for appropriate inspections by sampling not only during marketing but also during the manufacture of feedingstuffs; whereas the latter method of inspection may in particular cover the manufacturers' written records, Article 1 Directive 79/373/EEC is hereby amended as follows: 1. The following point is added to Article 1 (2): '(g) the approximation of the laws of the Member States relating to the making up, by mass or by volume, of certain prepackaged products.' 2. The following point is added to Article 2: '1. the minimum storage life of a compound feedingstuff: that the date until which, under proper storage conditions, that feedingstuff retains its specific properties.' 3. Article 5 is replaced by the following: 'Article 5 1. Member States shall prescribe that compound feedingstuffs may not be marketed unless the particulars listed below, which shall be clearly visible, legible and indelible and for which the manufacturer, packer, importer, seller or distributor established within the Community shall be held responsible, are shown, in a space provided for that purpose, on the packaging, on the container or on a label attached thereto: (a) the description "complete feedingstuff", "complementary feedingstuff", "mineral feedingstuff", "molassed feedingstuff", "complete milk replacer feed" or "complementary milk replacer feed", as appropriate; (b) the species or category of animal for which the compound feedingstuff is intended; (c) directions for the proper use of the feedingstuff indicating the purpose for which the feedingstuff is intended; (d) for all compound feedingstuffs except those intended for pets other than dogs and cats: the ingredients to be declared in accordance with Article 5c; (e) where appropriate, the declarations of the analytical constituents in the cases provided for in Part A of the Annex; (f) as relevant to the case, the declarations provided for in Part B of the Annex in columns 1, 2 and 3; (g) the name or business name and the address or registered place of business of the person responsible for the particulars referred to in this paragraph; (h) the net quantity expressed in units of mass in the case of solid products, and in units of mass or volume in the case of liquid products; (i) the minimum storage life, to be indicated in accordance with Article 5d (1); (j) the batch number if the date of manufacture is not given. 2. Member States shall prescribe that compound feedingstuffs, when marketed in tankers or similar vehicles or in accordance with Article 4 (2), shall be accompanied by a document containing the particulars referred to in paragraph 1 of this Article. For small quantities of feedingstuffs intended for the final user, these particulars may be brought to the purchaser's attention by means of an appropriate notice at the point of sale. 3. Member States shall prescribe that, in conjunction with the particulars listed in paragraph 1, only the following additional particulars may be put in the space referred to in paragraph 1: (a) the identification mark or trade mark of the person responsible for the labelling particulars; (b) the name or business name and the address or registered place of business of the manufacturer, if this is not the person responsible for the labelling particulars; (c) where appropriate, the batch number; (d) the country of production or manufacture; (e) the price of the product; (f) the description or trade name of the product; (g) for compound feedingstuffs intended for pets other than dogs and cats: the ingredients to be declared in accordance with Article 5c; (h) where appropriate, particulars relating to the provisions of Article 14 (a); (i) an indication of the physical condition of the feedingstuff or the specific processing it has undergone; (j) where appropriate, the declarations of the analytical constituents in the cases provided for in Part A of the Annex; (k) the declarations provided for in Part B of the Annex in columns 1, 2 and 4; (l) the date of manufacture to be indicated in accordance with Article 5d (2). 4. Member States may, for feedingstuffs produced and marketed in their territories: (a) permit the particulars specified in paragraph 1 (b) to (f) and (h) to be shown only in an accompanying document; (b) prescribe an official code number enabling the manufacturer to be identified where the latter is not responsible for the labelling particulars. 5. Member States shall prescribe that: (a) in the case of compound feedingstuffs constituted from no more than three ingredients, the particulars referred to in paragraph 1 (b) and (c) shall not be required where the ingredients used appear clearly in the description; (b) in the case of whole grain mixes, the declarations referred to in paragraph 1 (e) and (f) shall not be required; they may, however, be provided; (c) the descriptions "complete feedingstuff" or "complementary feedingstuff" in respect of feedingstuffs intended for pets other than dogs or cats may be replaced by the description "compound feedingstuff". In this case, the declarations required or allowed under this Article shall be those laid down for complete feedingstuffs; (d) the minimum storage life, the net quantity and the batch reference number may be marked outside the space reserved for the labelling particulars referred to in paragraph 1; in this case, the relevant expressions shall be accompanied by an indication of where the information appears. 6. For compound feedingstuffs for pets, the descriptions: (a) in English "compound feedingstuff", "complementary feedingstuff", and "complete feedingstuff" may be replaced by the descriptions "compound pet food", "complementary pet food" and "complete pet food" respectively; (b) in Spanish "pienso" may be replaced by the description "alimento"; (c) in Dutch "mengvoeder", "aanvullend diervoeder" and "volledig diervoeder" may be replaced by the descriptions "samengesteld voeder", "aanvullend samengesteld voeder" and "volledig samengesteld voeder" respectively.' 4. Articles 5a and 5b are deleted. 5. The following Articles are inserted: 'Article 5c 1. Where a declaration of the ingredients is provided, all the ingredients must be mentioned. 2. The listing of ingredients shall be subject to the following rules: (a) compound feedingstuffs intended for animals other than pets: listing of ingredients in descending order by weight; (b) compound feedingstuffs intended for pets: listing of ingredients either indicating the amount contained or naming them in descending order by weight. 3. The ingredients shall be described by their specific names; however, categories grouping several ingredients will be established in accordance with Article 10 (a); in that case, the indication of the specific name of the ingredient may be replaced by the name of the category to which the ingredient belongs. Use of one of these two forms of declaration shall exclude use of the other save where one of the ingredients used belongs to none of the categories which have been defined; in that case the ingredient, designated by its specific name, shall be mentioned in order of importance by weight in relation to the categories. 4. Where no measure has been adopted under Article 10 (a), Member States may retain the ingredient categories they have determined and allow the indication of the ingredients to be replaced by that of the categories. 5. The labelling of compound feedingstuffs for pets may also draw particular attention to the presence or low content of one or more ingredients which are essential aspects of the characteristics of the feedingstuff. In such a case, the minimum or maximum content, expressed in terms of percentage by weight of the ingredient(s) incorporated, must be clearly indicated either opposite the declaration drawing special attention to the ingredient(s) or in the list of ingredients or by mentioning the ingredient(s) and the percentage(s) by weight concerned opposite the corresponding category of ingredients. Article 5d 1. The minimum storage life shall be given by the following indications: - "use before . . ." followed by the date (day, month and year) in the case of microbiologically highly perishable feedingstuffs; - "best before . . ." followed by the date (month and year) in the case of other feedingstuffs. Where other Community provisions concerning compound feedingstuffs require indication of a minimum storage life, only the earliest date shall be indicated. 2. The date of manufacture shall be expressed as follows: "manufactured . . . . (days, months, or year(s)) before the minimum storage life expiry date indicated". Where Article 5 (5) (d) applies, the abovementioned entry shall be followed by an indication of where that storage life is indicated. Article 5e The person responsible for the labelling particulars of a compound feedingstuff may provide information in addition to that required under this Directive. However, such information: - may not be designed to indicate the presence or content of analytical constituents other than those the declaration of which is provided for in Article 5, - must not mislead the user, in particular by attributing to the feedingstuff effects or properties that it does not possess or by suggesting that it possesses special characteristics when in fact all similar feedingstuffs possess such characteristics, - must not claim that the feedingstuff will prevent, treat or cure a disease, - must relate to objective or quantifiable factors which can be substantiated, - must be clearly separated from all the particulars specified in Article 5.' 6. Article 6 is replaced by the following: 'Article 6 Member States shall prescribe that the general provisions contained in Part A of the Annex shall apply to the marketing of compound feedingstuffs.' 7. Articles 7 and 8 are deleted. 8. Article 10 is replaced by the following Articles: 'Article 10 In accordance with the procedure laid down in Article 13 and in the light of advances in scientific and technical knowledge: (a) categories grouping several ingredients shall be established not later than 22 January 1991; (b) a non-exclusive list of the main ingredients normally used and marketed for the preparation of compound feedingstuffs intended for species other than pets shall be established; for each of the products, the list shall establish a common name and description; in addition, in certain cases, minimum composition of requirements may also be laid down if such measures are found to be necessary for the better identification of ingredients; (c) a list shall be established of ingredients the use of which is prohibited in compound feedingstuffs for public or animal health reasons; (d) methods of calculating the energy value of compound feedingstuffs may be established; (e) amendments to the Annex and to the lists referred to in (b) and (c) above shall be adopted. Article 10a 1. Member States shall prescribe that the ingredients included on the list referred to in Article 10 (b) may be declared as such only under the names specified therein and on condition that they correspond to the descriptions and comply with any possible minimum compositional requirements contained therein. 2. Without prejudice to the measures referred to in Article 10 (c), Member States shall also allow the marketing of ingredients other than those on the list referred to in Article 10 (b) provided that they are of sound, genuine and merchantable quality and are declared under other names which cannot mislead the purchaser.' 9. Article 11 is replaced by the following: 'Article 11 For the purposes of marketing between the Member States, the particulars referred to in Article 5 shall be given in at least one of the national or official languages of the country of destination.' 10. Article 12 is replaced by the following: 'Article 12 Member States shall make all necessary arrangements for official inspection during manufacture or marketing, at least by sampling, in order to ensure compliance with the requirements of this Directive.' 11. The Annex is replaced by the Annex attached to this Directive. Article 2 Member States shall bring into force on 22 January 1992 the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31990L0110

1990

Commission Directive 90/110/EEC of 19 February 1990 amending the Annexes to 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 89/583/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 were consolidated by Commission Directive 85/429/EEC (3); Whereas the use of the colouring matter 'astaxanthin' has been widely tested in several Member States; whereas, on the basis of experience gained and studies undertaken, it appears that the use of this additive can be authorized throughout the Community and it is appropriate to authorize also, under certain conditions, the mixture of this additive with canthaxanthin; Whereas it is appropriate to amend the description of the characteristics of the additive carbadox preparation given in Annex I so as to correspond with the formulation of the product which should be marketed, to take account of technical improvements; Whereas sepiolite, used as a binder, corresponds in all respects to the principals laid down for the adoption of additives and it is appropriate to authorize its use throughout the Community; 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 70/524/EEC is hereby amended as set out in the Annex hereto. Article 2 Member States shall, by 30 November 1990 at the latest, bring into force the laws, regulations or administrative provisions necessary to comply with Article 1. They shall inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31990L0121

1990

Twelfth Commission Directive 90/121/EEC of 20 February 1990 adapting to technical progress Annexes II, III, IV, V and VI to 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 Directive 89/679/EEC (2), and in particular Article 8 (2) thereof, Whereas on the basis of the available information, certain provisionally permitted colouring agents, substances and preservatives may be definitively permitted, while 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 certain colouring agents, 11 a -hydroxypregn-4-ene-3,20-dione and its esters, hormones, zirconium with the exception of certain complexes, tyrothricin, antiandrogens of steroid structure, acetonitrile and tetrahydrozoline; Whereas, on the basis of the latest scientific and technical research, the use of lead acetate as a hair dye may be permitted in cosmetic products subject to certain limitations and requirements, provided that certain warnings are given on the labelling for the purpose of protecting public health; Whereas the use of the lakes of colouring agent CI 17 200 should be authorized; Whereas, on the basis of the latest scientific and technical research, the use of 3-decyloxy-2-hydroxy-1-aminopropane-hydrochloride as a preservative in cosmetic products and the use of Solvent yellow 98 as a colouring agent in nail care products, permitted subject to certain limitations and requirements; 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 amended as follows: 1. In Annex II: - in No 39, 'with the exception of that given in Annex V' is deleted, - in No 194, 'with the exception of those listed in Annex V' is deleted, - in No 289, 'compounds, with the exception of that mentioned in Annex V' is replaced by 'compounds, with the exception of that mentioned in Annex III, No 55 under the conditions stated', - in Nos 376 and 377, 'and their salts' is added, - the following substances are added: '385. 11 a-Hydroxypregn-4-ene-3,20-dione and its esters 386. Colouring agent CI 42 640 387. Colouring agent CI 13 065 388. Colouring agent CI 42 535 389. Colouring agent CI 61 554 390. Antiandrogens with steroid structure 391. Zirconium and its compounds, with the exception of the complexes under reference number 50 in Annex III (Part 1) and of zirconium lakes, salts and pigments of colouring agents listed with reference number 3 in Annex IV (Part 1) 392. Thyrothricine 393. Acetonitrile 394. Tetrahydrozoline and its salts'. 2. In Annex III, Part 1, in the French version only, under reference number 1, Boric acid: (a) in column (e), 'ne pas employer dans des produits de soins pour enfants en dessous de 3 ans' is replaced by 'ne pas employer dans des produits d'hygiène pour enfants en dessous de 3 ans' (the English text remains unchanged); (b) in column (f), 'ne pas employer pour les soins d'enfants en dessous de 3 ans' is replaced by 'ne pas employer pour l'hygiène des enfants en dessous de 3 ans' (the English text remains unchanged). 3. In Annex III, Part 1, reference number 55 is added as follows: 1.2.3.4.5.6 // // // // // // // a // b // c // d // e // f // // // // // // // '55 // Lead acetate // Only for hair-dyeing // 0,6 % calculated in lead // // Keep away from children. Avoid all contact with the eyes. Wash hands after use. Contains lead acetate. Do not use to dye eyelashes, eyebrows or moustasches. If irritation develops, discontinue use.' // // // // // // 4. In Annex III, Part 2, '31.12.1989' in the column headed 'Allowed until' is replaced by '31.12.1990' for the following reference numbers: 2. 1,1,1-Trichloroethane (methyl chloroform), and 4. 2,2-Dithiobis (pyridine 1-oxide), addition product with magnesium sulphate trihydrate. 5. In Annex IV, Part 1: (a) colour index number 42 640 is deleted; (b) for the colour index numbers 42 045 and 44 045 the cross sign 'X' is deleted from column 4 and inserted in column 3; (c) 'Other limitations and requirements' is deleted for colour index numbers 42 045 and 44 045; (d) a footnote reference '(3)' is added to the entry for colour index number 17 200. 6. In Annex IV, Part 2: (a) the following colouring agent is added: 1.2.3,6.7.8 // // // // // // Colour index-number or denomination // Colour // Field of application // Other limitations and requirements (2) // Admitted until 1.2.3.4.5.6.7.8 // // // 1 // 2 // 3 // 4 // // // // // // // // // // // 'Solvent yellow 98 // Yellow // // // × // // Only in nail care preparations maximum 0,5 % in the final product // 31. 12. 1991 // // // // // // // // (b) colour index numbers 13 065, 21 110, 42 045, 42 535, 44 045, 61 554 are deleted; (c) '31.12.1989' in the column headed 'Authorization valid until' is replaced by '31.12.1990' in so far as colour index numbers 26 100 and 73 900 are concerned; (d) '31.12.1990' in the column headed 'Authorization valid until' is replaced by '31.12.1991' in so far as colour index number 74 180 is concerned; 7. In Annex V, numbers 1, 3, 6, 9 are deleted. 8. (a) In Annex VI, Part 2, number 27 is added: 1.2.3.4.5.6 // // // // // // // a // b // c // d // e // f // // // // // // // 27 // 3-Decyloxy-2-hydroxy-1-amino propane-hydro-chlo- ride (Decominol) (INN)) // 0,5 % // // // 31. 12. 1990 // // // // // // (b) in Annex VI, Part 2, '31.12.1989' in column (f) is replaced by '31.12.1990' for the following substances: 2. Chlorphenesin (INN), 4. Alkyl (C12-C22) trimethyl-ammonium bromide and chloride (including Cetrimonium bromide) (*), 6. 4,4-Dimethyl-1,3-oxazolidine, 15. Benzethonium chloride (INN) (*), 16. Benzalkonium chloride (INN), bromide and saccharinate (*), 17. 1-[1,3-Bis (hydroxymethyl)2,5-dioxoimidazo- lidin-1-yl]-1,3-bis (hydroxymethy) urea, 20. Hexamidine (INN) and its salts (including isethionate and 4-hydroxybenzoate) (*), 21. Benzylhemiformal (a 1: 1 mixture of benzyloxymethanol and (benzyloxymethoxy) methanol). Article 2 1. Regardless of the dates of admission referred to in Article 1, points 4, 6 and 8, the Member States shall take all necessary measures to ensure that as from 1 January 1991, for the substances mentioned in Article 1, point 1, and as from 1 January 1992, for the substances mentioned in Article 1, points 3, 5, 6 and 8, 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. The Member States shall take all necessary measures to ensure that the products referred to in paragraph 1 containing the substances mentioned in Article 1, point 1 shall no longer be sold or otherwise disposed of to the final consumer after 31 December 1991 and that the products containing the substances mentioned in Article 1, points 3, 5, 6 and 8 shall no longer be sold or disposed of to the final consumer after 31 December 1993, if they do not comply with the requirements of this Directive. Article 3 1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive no later than 31 December 1990. They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive. Article 4 This Directive is addressed to the Member States.

31990L0088

1990

Council Directive 90/88/EEC of 22 February 1990 amending Directive 87/102/EEC for the approximation of the laws, regulations and administrative provisions of the Member States concerning consumer credit 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 5 of Council Directive 87/102/EEC (4) provides for the introduction of a Community method or methods of calculating the annual percentage rate of lcharge for consumer credit; Whereas it is desirable, in order to promote the establishment and functioning the internal market and to ensure that consumers benefit from a high level of protection, that one method of calculating the said annual percentage rate of charge should be used throughout the Community; Whereas it is desirable, with a view to introducing such a method and in accordance with the definition of the total cost of credit to the consumer, to draw up a single mathematical formula for calculating the annual percentage rate of charge and for determining credit cost items to be used in the calculation by indicating those costs which must not be taken into acount; Whereas, during a trasitional period, Member States which prior to the date of notification of this Directive, apply laws which permit the use of another mathematical formula for calculating the annual percentage rate of charge may continue to apply such laws; Whereas, before expiry of the transitional period and in the light of experience, the Council will, on the basis of a proposal from the Commission, take a decision which will make it possible to apply a single Community mathematical formula; Whereas it is desirable, whenever necessary, to adopt certain hypotheses for calculating the annual percentage rate of charge; Whereas by virtue of the special nature of loans guaranteed by a mortgage secured on immoveable property it is desirable that such credit should continue to be partially excluded from this Directive; Whereas the information which must be communicated to the consumer in the written contract should be amplified, Article 1 Directive 87/102/EEC is hereby amended as follows: 1. In Article 1 (2), points (d) and (e) shall be replaced by the following: '(d) "total cost of the credit to the consumer" means all the costs, including interest and other charges, which the consumer has to pay for the credit.'; '(e) "annual percentage rate of charge" means the total cost of the credit to theconsumer, expressed as an annual percentage of the amount of the credit granted and calculated in accordance with Article 1a'. 2. The following Article shall be inserted: 'Article 1a 1. (a) The annual percentage rate of charge, which shall be that equivalent, on an annual basis, to the present value of all commitments (loans, repayments and charges), future or existing, agreed by the creditor and the borrower, shall be calculated in accordance with the mathematical formula set out in Annex II. (b) Four examples of the method of calculation are given in Annex III, by way of illustration. 2. For the purpose of calculating the annual percentage rate of charge, the "total cost of the credit to the consumer" as defined in Article 1 (2) (d) shall be determined, with the exception of the following charges: (i) charges payable by the borrower for non-compliance with any of his commitments laid down in the credit agreement; (ii) charges other than the purchase price which, in purchases of goods or services, the consumer is obliged to pay whether the transaction is paid in cash or by credit; (iii) charges for the transfer of funds and charges for keeping an account intended to receive payments towards the reimbursement of the credit the payment of interest and other charges except where the consumer doesn ot have reasonable freedom of choice in the matter and where such charges are abnormally high; this provision shall not, however, apply to charges for collection of such reimbursements or payments, whether made in cash or otherwise; (iv) membership subscriptions to associations or groups and arising from agreements separate from the credit agreement, even though such subscriptions have an effect on the credit terms; (v) charges for insurance or guarantees; included are, however, those designed to ensure payment to the creditor, in the event of the death, invalidity, illness or unemployment of the consumer, of a sum equal to or less than the total amount of the credit togehter with relevant interest and other charges which have to be imposed by the creditor as a condition for credit being granted. 3. (a) Where credit transactions referred to in this Directive are subject to the provisions of national laws in force on 1 March 1990 which impose maximum limits on the annual percentage rate of charge for such transactions and, where such provisions permit standard costs other than those described in paragraph 2 (i) to (v) not to be included in those maximum limits, Member States may, solely in respect of such transactions, not include the aforementioned costs when calculating the annual percentage rate of charge, as stipulated in this Directive, provided that there is a requirement, in the cases mentioned in Article 3 and in the credit agreement, that the consumer be informed of the amount and inclusion thereof in the payments to be made. (b) Member States may no longer apply point (a) from the date of entry into force of the single mathematical formula for calculating the annual percentage rate of charge in the Community, pursuant to the provisions of paragraph 5 (c). 4. (a) The annual percentage rate of charge shall be calculated at the time the credit contract is concluded, without prejudice to the provisions of Article 3 concerning advertisements and special offers. (b) The calculation shall be made on the assumption that the credit contract is valid for the period agreed and that the creditor and the consumer fulfil their obligations under the terms and by the dates agreed. 5. (a) As a transitional measure, notwithstanding the provisions of paragraph 1 (a), Member States which, prior to 1 March 1990, applied legal provisions whereby a mathematical formula different from that given in Annex II could be used for calculating the annual percentage rate of charge, may continue applying that formula within their territory for a period of three years starting from 1 January 1993. Member States shall take the appropriate measures to ensure that only one mathematical formula for calculating the annual percentage rate of charge is used within their territory. (b) Six months before the expiry of the time limit laid down in point (a) the Commission shall submit to the Council a report, accompanied by a proposal, which will make it possible in the light of experience, to apply a single Community mathematical formula for calculating the annual percentage rate of charge. (c) The Council shall, acting by a qualified majority on the basis of the proposal from the Commission, take a decision before 1 January 1996. 6. In the case of credit contracts containing clauses allowing variations in the rate of interest and the amount or level of other charges contained in the annual percentage rate of charge but unquantifiable at the time when it is calculated, the annual percentage rate of charge shall be calculated on the assumption that interest and other charges remain fixed and will apply until the end of the credit contract. 7. Where necessary, the following assumptions may be made in calculating the annual percentage rate of charge: - if the contract does not specify a credit limit, the amount of credit granted shall be equal to the amount fixed by the relevant Member State, without exceeding a figure equivalent to ECU 2 000; - if there is no fixed timetable for repayment, and one cannot be deduced from the terms of the agreement and the means for repaying the credit granted, the duration of the credit shall be deemed to be one year; - unless otherwise specified, where the contract provides for more than one repayment date, the credit will be made available and the repayments made at the earliest time provided for in the agreement'. 3. Article 2 (3) shall be replaced by the following: '3. The provisions of Article 1a and of Articles 4 to 12 shall not apply to credit agreements or agreements promising to grant credit, secured by mortgage on immovable property, insofar as these are not already excluded from the Directive under paragraph 1 (a).' 4. The following subparagraph shall be added to Article 4 (2): '(c) a statement of the amount, number and frequency or dates of the payments which the consumer must make to repay the credit, as well as of the payments for interest and other charges; the total amount of these payments should also be indicated where possible; (d) a statement of the cost items referred to in Article 1a (2) with the exception of expenditure related to the breach of contractual obligations which were not included in the calculation of the annual percentage rate of charge but which have to be paid by the consumer in given circumstances, together with a statement indentifying such circumstances. Where the exact amount of those items is known, that sum is to be indicated; if that is not the case, either a method of calculation or as accurate an estimate as possibe is to be provided where possible'. 5. Article 5 shall be deleted. 6. The Annex shall become Annex I and the following point shall be added to paragraph 1: '(ix) the obligation on the consumer to save a certain amount of money which must be placed in a special account'. 7. Annexes II and III attached hereto shall be added. Article 2 1. Member States shall take the measures necessary to cumply with this Directive not later than 31 December 1992 and shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 3 This Directive is addressed to the Member States.

31990L0128

1990

Commission Directive 90/128/EEC of 23 February 1990 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 of 21 December 1989 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 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 plastics materials and articles, a suitable instrument is a specific Directive within the meaning of Article 3 of Directive 89/109/EEC, the general provisions of which are also applicable to the case in question; Whereas the scope of this Directive must coincide with that of Council Directive 82/711/EEC (2); Whereas since the rules established in this Directive are not suitable for ion-exchange resins, these materials and articles will be covered by a subsequent specific Directive; Whereas the establishment of a list of approved substances accompanied by a limit an overall migration and, where necessary, by other specific restrictions will be sufficient to achieve the objective laid down in Article 2 of Directive 89/109/EEC; Whereas the stage reached in the work at Community level does not yet permit adoption of a complete list of the authorized substances applicable to all types of plastics materials and articles and therefore the substances which are currently used in at least one Member State can continue to be used pending a decision on inclusion in the Community list; whereas this Directive will accordingly be extended in due course to the substances and sectors provisionally excluded; Whereas the overall migration limit is a measure of the inertness of the material and prevents an unacceptable change in the composition of the foodstuffs, and, moreover, reduces the need for a large number of specific migration limits or other restrictions, thus giving effective control; Whereas Directive 82/711/EEC lays down the basic rules necessary for testing migration of the constituents of plastics materials and articles and Council Directive 85/572/EEC (3) establishes the list of simulants to be used in the migration tests; Whereas Council Directive 78/142/EEC (1) lays down limits for the quantity of vinyl chloride present in plastics materials and articles prepared with this substance and for the quantity of vinyl chloride released by these materials and articles, and Directives 80/766/EEC (2) and 81/432/EEC (3) establish the Community methods of analysis for controlling these limits; Whereas Commission Directive 80/590/EEC (4) determines the symbol that may accompany any material and article intended to come into contact with foodstuffs; Whereas in view of potential liability, there is a need for the written declaration provided for in Article 6 (5) of Directive 89/109/EEC whenever professional use is made of plastics materials and articles which are not by their nature clearly intended for food use; Whereas, in accordance with Article 3 of Directive 89/109/EEC, the Scientific Committee for Food has been consulted on the provisions liable to affect public health; 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 plastics materials and articles and parts thereof: (a) consisting exclusively of plastics, or (b) composed of two or more layers of materials, each consisting exclusively of plastics, which are bound together by means of adhesives or by any other means, which, in the finished product state, are intended to come into contact or are brought into contact with foodstuffs and are intended for that purpose. 3. For the purposes of this Directive, 'plastics' shall mean the organic macromolecular compounds obtained by polymerization, polycondensation, polyaddition or any other similar process from molecules with a lower molecular weight or by chemical alteration of natural macromolecules. Silicones and other similar macromolecular compounds shall also be regarded as plastics. Other substances or matter may be added to such macromolecular compounds. However, the following shall not be regarded as plastics: (i) varnished or unvarnished regenerated cellulose film, covered by Council Directive 83/229/EEC (5), as amended by Directive 86/388/EEC (6); (ii) elastomers and natural and synthetic rubber; (iii) paper and paperboard, whether modified or not by the addition of plastics; (iv) surface coatings obtained from: - paraffin waxes, including synthetic paraffin waxes, and/or micro-crystalline waxes, - mixtures of the waxes listed in the first indent with each other and/or with plastics; (v) ion-exchange resins. 4. This Directive shall not apply, until further action by the Commission, to materials and articles composed of two or more layers, one or more of which does not consist exclusively of plastics, even if the one intended to come into direct contact with foodstuffs does consist exclusively of plastics. Article 2 Plastics materials and articles shall not transfer their constituents to foodstuffs in quantities exceeding 10 milligrams per square decimetre of surface area of material or article (mg/dm2) (overall migration limit). However, this limit shall be 60 milligrams of the constituents released per kilogram of foodstuff (mg/kg) in the following cases: (a) articles which are containers or are comparable to containers or which can be filled, with a capacity of not less than 500 millilitres (ml) and not more than 10 litres (l); (b) articles which can be filled and for which it is impracticable to estimate the surface area in contact with foodstuffs; (c) caps, gaskets, stoppers or similar devices for sealing. Article 3 1. Only those monomers and other starting substances listed in Annex II, Sections A and B may be used for the manufacture of plastics materials and articles subject to the restrictions specified. 2. From the date of notification of this Directive, the list in Annex II, Section A may be amended: - either by adding substances listed in Annex 2, Section B, according to the criteria in Annex II of Directive 89/109/EEC, or - by including 'new substances', i.e. substances which are listed neither in Section A nor in Section B of Annex 2, according to Article 3 of Directive 89/109/EEC. 3. From the date of notification of this Directive no Member State shall authorize any new substance for use within its territory except under the procedure in Article 4 of Directive 89/109/EEC. 4. As from 1 January 1993, only those monomers and other starting substances listed in Annex II, Section A shall be used for the manufacture of plastics materials and articles, subject to the restrictions specified therein. However, before 1 January 1992 it may be decided that, in some justified cases, for certain substances listed in Annex II, section B, this time limit will be postponed. 5. However the lists appearing in Annex II, Sections A and B do not yet include monomers and other starting substances used only in the manufacture of: - surface coatings obtained from resinous or polymerized products in liquid, powder or dispersion form, such as varnishes, lacquers, paints, etc., - silicones, - epoxy resins, - products obtained by means of bacterial fermentation, - adhesives and adhesion promoters, - printing inks. Article 4 The specific migration limits in the list set out in Annex II are expressed in mg/kg. However, such limits are expressed in mg/dm2 in the following cases: (a) articles which are containers or are comparable to containers or which can be filled, with a capacity of less than 500 ml or more than 10 l; (b) sheet, film or other materials which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of such materials and the quantity of foodstuff in contact therewith. In these cases, the limits set out in Annex II, expressed in mg/kg shall be divided by the conventional conversion factor of 6 in order to express them in mg/dm2. Article 5 1. Verification of compliance with the migration limits shall be carried out in accordance with the rules laid down in Directives 82/711/EEC and 85/572/EEC and the further provisions set out in Annex I. 2. The verification of compliance with the specific migration limits provided for in paragraph 1 shall not be compulsory, if it can be established that compliance with the overall migration limit laid down in Article 2 implies that the specific migration limits are not exceeded. Article 6 1. At the marketing stages other than the retail stages, the plastics materials and articles which are intended to be placed in 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 plastics materials and articles which by their nature are clearly intended to come into contact with foodstuffs. Article 7 1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1990. They shall forthwith inform the Commission thereof. 2. Member States shall: - permit the trade in and use of plastics materials and articles complying with this Directive before 1 January 1991, - prohibit trade in and use of plastics materials and articles intended to come into contact with foodstuffs and which do not comply with this Directive as from 1 January 1993. Article 8 This Directive is addressed to the Member States.

31990L0119

1990

COUNCIL DIRECTIVE of 5 March 1990 of hybrid breeding pigs for breeding (90/119/EEC) Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 88/661/EEC of 19 December 1988 on the zootechnical standards applicable to breeding animals of the porcine species (1) and in particular Article 8 thereof, Having regard to the proposal from the Commission, Whereas Directive 88/661/EEC was particularly intended gradually to liberalize intra-Community trade in hybrid breeding pigs; whereas, for this purpose, additional harmonization with regard to the acceptance of such animals, for breeding purposes, is necessary; Whereas the provisions concerning acceptance for breeding relate both to animals as well as their semen, ova and embryos; Whereas, in this respect, it is necessary to prevent national provisions relating to the acceptance for breeding purposes of hybrid breeding pigs and their semen, ova and embryos from constituting a prohibition or restriction of intra-Community trade or an obstacle thereto whether in the case of natural service, artificial insemination or the taking of ova or embryos; Whereas female and male hybrid breeding pigs, their semen, ova and embryos should be subject to no prohibition, restriction or obstacle in connection with breeding; Whereas the provision that semen, ova and embryos must be manipulated by officially approved staff is capable of providing the guarantees necessary for attaining the desired end; Whereas in the light of particular conditions currently existing in Spain and Portugal it is necessary to provide for a longer period for the implementation of this Directive in those Member States, Article 1 Member States shall ensure that, without prejudice to animal health rules there is no prohibition or restriction of or obstacle to: — the acceptance of hybrid breeding female pigs for breeding, — the acceptance of hybrid breeding male pigs for natural service, — the acceptance for artificial insemination of hybrid breeding male pigs whose line has been tested for monitoring performance and assessing its genetic value, — the use of the semen of the animal referred to in the third indent, — the acceptance, for official testing, of hybrid breeding male pigs or the use of the semen of such pigs within quantitative limits necessary for the tests for monitoring their performance and assessing their genetic value to be carried out, — the use of ova and embryos from hybrid breeding female pigs. Article 2 Member States shall ensure that, without prejudice to animal health rules, for marketing, the semen, ova and embryos are collected, treated and stored by an officially approved centre or officially approved staff. Article 3 Member States shall bring into force the laws, regulations and administrative provisionns necessary to comply with this Directive by not later than 1 January 1991. They shall forthwith inform the Commission thereof. However, the Kingdom of Spain and the Portuguese Republic shall have an additional period of time of two years within which to comply with this Directive. Article 4 This Directive is addressed to the Member States.

31990L0118

1990

COUNCIL DIRECTIVE of 5 March 1990 on the acceptance of pure-bred breeding pigs for breeding (90/118/EEC) Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 88/661/EEC of 19 December 1988 on the zootechnical standards applicable to breeding animals of the porcine species (1) and in particular Article 3 thereof, Having regard to the proposal from the Commission, Whereas Directive 88/661/EEC was particularly intended gradually to liberalize intra-Community trade in purebred breeding pigs; whereas, for this purpose, additional harmonization with regard to the acceptance of such animals for breeding purposes is necessary; Whereas the provisions concerning acceptance for breeding relate both to animals as well as their semen, ova and embryos; Whereas, in this respect, it is necessary to prevent national provisions relating to the acceptance for breeding purposes of pure-bred breeding pigs and their semen, ova and embryos from constituting a prohibition or restriction of intra-Community trade or an obstacle thereto whether in the case of natural service, artifical insemination or the taking of ova or embryos; Whereas pure-bred female pigs, their ova and embryos should be subject to no prohibition, restriction or obstacle in connection with breeding; Whereas artificial insemination constitutes an important technique for increasing the use of the best breeders and, hence, for improving the procine species; whereas in so doing, however, any impairment of the pedigree must be avoided, particularly with regard to male breeders, which must possess all guarantees of their genetic value and of their freedom from hereditary defects; Whereas it is necessary to make a distinction between the acceptance for artificial insemination of pure-bred breeding pigs and their semen which have undergone all the official tests laid down for their breed in a Member State and the acceptance of them solely for the purposes of official testing; Whereas it is useful to establish a procedure for solving, in particular, disputes that may arise in the assessment of the result of tests; Whereas the provision that semen, ova and embryos must be manipulated by officially approved staff is capable of providing the guarantees necessary for attaining the desired end; Whereas in the light of particular conditions currently existing in Spain and Portugal it is necessary to provide for a longer period for the implementation of this Directive in those Member States, Article 1 Member States shall ensure that, without prejudice to animal health rules, there is no prohibition or restriction of or obstacle to: — the acceptance of pure-bred breeding female pigs for breeding, — the acceptance of pure-bred breeding male pigs for natural service, — the use of ova and embryos from pure-bred breeding female pigs. Article 2 1. A Member State may not prohibit, restrict or impede: — the acceptance for artificial insemination within its territory of pure-bred breeding male pigs or the use of their semen when those animals have been accepted for artificial insemination in a Member State on the basis of tests for monitoring their performance and assessing their genetic value to be carried out in accordance with Commission Decision 89/507/EEC (2), — the acceptance for official testing of pure-bred breeding male pigs or the use of their semen within the quantitative limits necessary for the tests for monitoring their performance and assessing their genetic value to be carried out in accordance with Decision 89/507/EEG by officially approved associations or organizations. 2. Where implementation of the provisions of paragraph 1 would give rise to disputes, particularly with regard to interpretation of the tests, operators shall have the right to seek the opinion of an expert. In the light of the expert's opinion, measures may be adopted at the request of a Member State in accordance with the procedure laid down in Article 4. 3. The general rules for implementing paragraph 2 shall, where necessary, be adopted in accordance with the procedure set out in Article 4. Article 3 Member States shall ensure that, without prejudice to animal health rules, for marketing, the semen, ova and embryos are collected, treated and stored by an officially approved centre or officially approved staff. Article 4 Where the procedure laid down in this Article is to be followed, the Standing Committee on Zootechnics, set up by Decision 77/505/EEC (3) shall act in accordance with the rules set out in Article 11 of Directive 88/661/EEC (4). Article 5 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by not later than 1 January 1991. They shall forthwith inform the Commission thereof. However, the Kingdom of Spain and the Portuguese Republic shall have an additional period of time of two years within which to comply with this Directive. Article 6 This Directive is addressed to the Member States.

31990L0168

1990

Council Directive 90/168/EEC of 26 March 1990 amending Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant products Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof, Having regard to the proposal the Commission (1), Having regard to the opinion of the European Parliament (2), Whereas, by Directive 77/93/EEC (3), as last amended by Directive 89/439/EEC (4), the Council laid down protective measures against the introduction into the Member States of organisms harmful to plants or plant products; whereas the protection of plants against such organisms is absolutely necessary to increase agricultural productivity, which is one of the objectives of the common agricultural policy; Whereas, at present, in addition to providing for checks by consignor Member States, Directive 77/93/EEC allows checks by Member States of destination; whereas, in the interest of the free movement of plants and plant products within the Community, which is an element essential to agricultural productivity and contributes to the proper functioning of the common agricultural policy, these latter checks should be progressively reduced and a better balance established, in the matter of checks, between the consignor Member State and the Member State of destination, with greater responsibility being placed on the former; whereas Article 11 of Directive 77/93/EEC should be amended accordingly; Whereas it has become necessary to improve the functioning of the safeguard clause provided for in Article 15 of Directive 77/93/EEC; whereas safeguard measures should normally be adopted by the Member State where the problem originates and the Commission should be informed of all events which require the adoption of safeguard measures, Article 1 Directive 77/93/EEC is hereby amended as follows: 1. In Article 11 (3), second subparagraph, 'one-third' is replaced by 'a certain percentage'. 2. After Article 11 (3), second subparagraph, the following subparagraph is added: 'This percentage may be determined on the basis of the plant or plant product categories, in accordance with the procedure laid down in Article 16a. It shall be lower than 33 % and shall be gradually reduced to reach zero by the time that Member States have brought into effect the new checking arrangements in compliance with the provisions intended for the completion of the internal market.' 3. The following paragraph is inserted in Article 11: '3a. The documentary checks referred to in paragraph 1 (a) and the identity checks referred to in paragraph 1 (e) shall be carried out only at the time and place at which customs or other administrative formalities in connection with the movement of goods are completed. In accordance with the procedure laid down in Article 16a, it shall be decided what percentage of consignments should be subject to occasional documentary and identity checks by sampling, according to plant or plant product categories. This percentage shall be gradually reduced to reach zero by the time that Member States have brought into effect the new checking arrangements in compliance with the provisions intended for the completion of the internal market.' 4. Article 15 (1) is replaced by the following: '1. (a) Each Member State shall immediately notify the Commission and the other Member States of the actual or suspected occurence of harmful organisms not known hitherto to be present in its territory. It shall also inform the Commission and the other Member States of the protective measures which it has taken or intends to take. These measures must, inter alia, be such as to prevent risk of the spread of the harmful organism concerned in the territory of the other Member States. (b) In respect of consignments of plants, plant products or other objects from third countries considered to involve an imminent danger of the introduction or spread of the harmful organisms referred to in (a), the Member State concerned shall immediately take the measures necessary to protect the territory of the Community from that danger and shall inform the Commission and the other Member States thereof. (c) Where a Member State considers that there is an imminent danger other than that referred to in (b), it shall immediately notify the Commission and the other Member States of the measures which it would like to see taken. If it considers that these measures are not being taken in sufficient time to prevent the introduction or spread of a harmful organism in its territory, it may temporarily take any additional measures which it deems necessary, as long as the Commission has not adopted measures pursuant to paragraph 2. The Commission will present a report to the Council on the operation of this provision, together with any proposals, by 31 December 1992.' 5. The following paragraph is added to Article 15: '3. The detailed rules for applying paragraph 1 shall be adopted, as necessary, in accordance with the procedure laid down in Article 16a.' Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1991. Article 3 This Directive is addressed to the Member States.

31990L0167

1990

COUNCIL DIRECTIVE of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community (90/167/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 the conditions with which medicated feeding-stuffs should comply, in particular as concerns their preparation, supply, use and administration to animals, have no small influence on the rational development of the keeping and on the rearing of animals and the production of products of animal origin; Whereas the keeping and rearing of animals constitutes a major portion of the common agricultural policy; Whereas, to safeguard public health from any dangers arising from the use of medicated feedingstuffs for animals intended for food production, and to prevent distortions in competition in the keeping and rearing of farm animals, conditions should be laid down regarding the preparation, placing on the market and use of medicated feedingstuffs and regarding intra-Community trade in those products; Whereas Community rules regarding veterinary medicinal products, and in particular Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of Member States relating to veterinary medicinal products (4), and Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (5), as amended by Directive 87/20/EEC (6), should be taken into account; Whereas medicated feedingstuffs must, with regard to the medicinal components, comply with the rules applicable to veterinary medicinal products; whereas, however, in the manufacture of medicated feedingstuffs simple mixing is the main process; whereas only authorized medicated pre-mixes may be used and precise instructions must be given for the use of these medicated feedingstuffs; whereas, in addition, the person responsible for manufacture must have at his disposal sufficient staff and premises so that can meet the requirements of this Directive; Whereas it is the manufacturer's responsibility to carry out a quality control on the products placed on the market; whereas, however, the manufacturing unit should be placed under satisfactory official control; Whereas, for the purposes of this Directive, the rules concerning checks and the safeguard measures laid down by 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 (7) should be used; Whereas the supply of medicated feedingstuffs to stock-farmers may only be on prescription of a veterinarian, who must himself comply with particular conditions when issuing the prescription; Whereas, in order for there be to effective control, the persons concerned must be required to keep a register or, where appropriate, to retain the documents for a specified period of time; Whereas, pending the complete harmonization of the rules authorizing the placing of veterinary medicinal products on the market, the possibility of making national derogations, in particular with respect to the manufacture of intermediate products or certain medicated pre-mixes, should be kept, Article 1 This Directive lays down, without prejudice to the adoption of the list laid down in Article 2 (3) of Directive 81/851/EEC, the conditions other than those of animal health, governing the preparation, placing on the market and use of medicated feedingstuffs within the Community. This Directive shall not affect Community rules applicable to additives used in feedingstuffs, or national rules adopted pursuant to the said rules, and in particular those applicable to the additives entered in Annex II of Directive 70/524/EEC (8), as last amended by Commission Directive 89/583/EEC (9). Article 2 For the purposes of this Directive the definitions appearing in Article 1 (2) of Directive 81/851/EEC and Article 2 of Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs (10), as last amended by Directive 90/44/EEC (11), shall apply as necessary. The following definitions shall also apply: (a) ‘authorized medicated pre-mix’: any pre-mix for the manufacture of medicated feedingstuffs as defined in Article 1 (2) of Directive 81/851/EEC which has been granted an authorization in accordance with Article 4 of that Directive; (b) ‘placing on the market’: the holding in the territory of the Community for sale or disposal in any other form whatever to third parties, whether or not for consideration, and actual sale or disposal. Article 3 1. Member States shall prescribe that, as regards the medicinal component, medicated feedingstuffs may be manufactured from authorized medicated pre-mixes only. By way of derogation from the first subparagraph, Member States may, provided they comply with the requirements of Article 4 (4) of Directive 81/851/EEC: — subject to any specific conditions laid down in authorizations to place authorized medicated pre-mixes on the market, authorize intermediate products which are prepared from such medicated pre-mixes authorized in accordance with Article 4 of Directive 81/851/EEC and from one or more feedingstuffs and which are intended for the subsequent manufacture of medicated feedingstuffs ready for use. Member States shall take all necessary steps to ensure that intermediate products are manufactured only by establishments authorized in accordance with Article 4 and that they are the subject of a declaration to the competent authority, — authorize the veterinarian to have manufactured under the conditions laid down in Article 4 (3) of Directive 81/851/EEC, and under his responsibility and on prescription, medicated feedingstuffs from several authorized medicated pre-mixes, provided that there is no specific authorized therapeutic agent in pre-mix form for the disease to be treated or for the species concerned. Until the date on which the Member States have to comply with the new rules laid down in Article 4 (3) of Directive 81/851/EEC, national rules governing the above conditions shall remain applicable, with due regard for the general provisions of the Treaty. 2. Products authorized pursuant to paragraph 1 shall be subject to the rules laid down in Articles 24 to 50 of Directive 81/851/EEC. Article 4 1. Member States shall take all necessary measures to ensure that medicated feedingstuffs are manufactured only under the conditions set out below: (a) the manufacturer shall have premises which have been previously approved by the competent national authority, technical equipment and suitable and adequate storage and inspection facilities; (b) the medicated feedingstuffs manufacturing plant shall be manned by staff whose knowledge of and qualifications in mixing technology are adequate; (c) the producer shall be responsible for ensuring that: — only feedingstuffs or combinations thereof which comply with Community provisions on feedingstuffs are used, — the feedingstuff used produces a homogeneous and stable mix with the authorized medicated pre-mix, — the authorized medicated pre-mix is used during the manufacturing process in accordance with the conditions laid down when authorization for placing on the market was given and, in particular, that: (i) there is no possibility of any undesirable interaction between veterinary medicinal products, additives and feedingstuffs; (ii) the medicated feedingstuff will keep for the stipulated period; (iii) the feedingstuff to be used for producing the medicated feedingstuff does not contain the same antibiotic or the same coccidiostat as those used as an active substance in the medicated pre-mix; — the daily dose of medicinal product is contained in a quantity of feedingstuff corresponding to at least half the daily feed ration of the animals treated or, in the case of ruminants, corresponding to at least half the daily requirement of nonmineral supplementary feedingstuffs; (d) premises, staff and equipment used and participating in the entire manufacturing process must comply with the manufacturing hygiene rules and principles of the Member State in question; the manufacturing process must conform to the rules of good manufacturing practice; (e) the medicated feedingstuffs manufactured shall undergo regular checks — including appropriate laboratory tests of homogeneity — by the manufacturing establishments, under the supervision and periodic control of the official department, to ensure that the medicated feedingstuff complies with the requirements of this Directive, especially in respect of its homogeneity, stability and storability; (f) manufacturers shall be obliged to keep daily records of the types and quantities of the authorized medicated pre-mixes and feedingstuffs used and of the medicated feedingstuffs manufactured, held or dispatched, together with the names and addresses of the breeders or holders of the animals, and in the case provided for in Article 10 (2), the name and address of the authorized distributor and, where appropriate, the name and address of the prescribing veterinarian. The records, which must meet the requirements of Article 5 of Directive 81/851/EEC, must be kept for at least three years after the date of the last entry and must be made available at any time to the competent authorities in case of checking; (g) pre-mixes and medicated feedingstuffs shall be stored in suitable separate and secured rooms or hermetic containers which are specially designed for the storage of such products. 2. Member States may, by way of derogation from paragraph 1, subject to any additional guarantees appropriate, authorize the manufacture of medicated feedingstuffs on farms provided that the said paragraph is complied with. Article 5 1. Member States shall prescribe that medicated feedingstuffs may be placed on the market only in packages or containers sealed in such a way that, when the package is opened, the closure or seal is damaged and they cannot be re-used. 2. Where road tankers or similar containers are used to place medicated feedingstuffs on the market, these must be cleaned before any re-use in order to prevent any subsequent undesirable interaction or contamination. Article 6 1. Member States shall take all necessary measures to ensure that medicated feedingstuffs are not put into circulation unless the labelling complies with the Community provisions in force. Furthermore, the packages or containers referred to in Article 5 (1) shall be clearly marked ‘Medicated Feedingstuffs’. 2. Where road tankers or similar containers are used to place medicated feedingstuffs on the market, it shall be sufficient for the information referred to in paragraph 1 to be contained in the accompanying documents. Article 7 1. Member States shall take ail necessary measures to ensure that a medicated feedingstuff cannot be held, placed on the market or used unless it has been manufactured in accordance with this Directive. 2. Subject to the requirements of Article 4 (2) of Directive 81/851/EEC with regard to the tests to be carried out on veterinary medicinal products, Member States may, however, for scientific purposes, provide for derogations from this Directive, provided there is adequate official control. Article 8 1. Member States shall ensure that medicated feedingstuffs are not supplied to stockfarmers or holders of animals except on presentation of a prescription from a registered veterinarian on the following terms: (a) the veterinarian's prescription shall be made out on a form which contains the headings shown on the specimen in Annex A; the original form shall be for the manufacturer or, where appropriate, a distributor approved by the competent authority of the Member State of destination of the medicated feedingstuffs; (b) the competent national authorities shall determine the number of copies of the prescription form, the persons who are to receive a copy and the period for which the original and the copies must be kept; (c) medicated feedingstuffs may not be used for more than one treatment under the same prescription. The veterinary prescription shall be valid only for a period determined by the competent national authority which may not exceed three months; (d) the veterinarian's prescription may be used only for animals treated by him. He must first satisfy himself that: (i) the use of this medication is justified for the species concerned on veterinary grounds; (ii) administration of the medicinal product is not incompatible with a previous treatment or use and that there is no contra-indication or interaction where several pre-mixes are used; (e) the veterinarian must: (i) prescribe the medicated feedingstuffs only in such quantities as, within the maximum limits laid down by the national authorization for placing medicated pre-mixes on the market, are necessary for the purpose of the treatment; (ii) satisfy himself that the medicated feedingstuff and the feedingstuff currently used to feed treated animals do not contain the same antibiotic or the same coccidiostat as active substances. 2. However, in the case of anthelmintic medicinal products (vermifuges), Member States may, pending the review to be carried out under Directive 81/851/EEC of the risks associated with the use of these groups of substances, derogate for five years after the adoption of this Directive from the obligation laid down in paragraph 1 not to supply medicated feedingstuffs obtained from authorized medicated pre-mixes except on presentation of a veterinary prescription, provided that: — the medicated pre-mixes used do not contain active substances which belong to the chemical groups used, in their territory, on medical prescription for human medicine, — the medicated feedingstuffs accorded such authorization are used in their territory only prophylactically and in the dosages necessary for the purpose in question. Member States applying such a derogation shall inform the Commission and the other Member States thereof within the Standing Veterinary Committee, before the date provided for in the first indent of the first subparagraph of Article 15, specifying in particular the nature of the medicinal products and animal species that it covers. Not more than six months before the expiry of the five-year period laid down in the first subparagraph the Commission shall report to the Council on the risks associated with the use of these groups of substances and may include proposals on which the Council will decide by a qualified majority. 3. Where medicated feedingstuffs are administered to animals whose meat, flesh, offal or products are intended for human consumption, the stockfarmer or holder of the animals concerned must ensure that treated animals are not slaughtered in order to be offered for consumption before the end of the withdrawal period and that products obtained from a treated animal before the end of such a withdrawal period are not disposed of with a view to their being offered for human consumption. Article 9 1. Member States shall take all necessary measures to ensure that medicated feedingstuffs are issued directly to the stockfarmer or holder of the animals only by the manufacturer or distributor specially approved by the competent authority of the Member State of destination. Furthermore, medicated feedingstuffs for the treatment of animals whose meat, flesh, offal or products are intended for human consumption may not be issued unless: — they do not exceed the quantities prescribed for the treatment, in accordance with the veterinary prescription where this is provided for, — they are not issued in quantities greater than one month's requirements as established in accordance with the stipulations of the first indent. 2. However, notwithstanding paragraph 1, Member States may in special cases authorize distributors specifically approved for that purpose to issue, on the basis of a veterinary prescription, medicated feedingstuffs in small quantities, prepacked and ready for use, and prepared, without prejudice to Article 8 (2) in accordance with the requirements of this Directive, provided that these distributors: — comply with the same conditions as the manufacturer regarding the keeping of registers and the storage, transport and issue of the products concerned, — are subject to special checking for the purpose, under the supervision of the competent veterinary authority, — may supply only prepacked or prepackaged medicated feedingstuffs ready for use by the holder or stock-farmer that have on the packaging or containers instructions for the use of the said medicated feedingstuffs and, in particular, an indication of the withdrawal period. 3. The provisions of paragraph 2 shall not affect national rules on the legal ownership of the medicated feedingstuffs. Article 10 1. Member States shall ensure that, without prejudice to animal-health rules, there are no prohibitions, limitations or obstacles in respect of intra-Community trade — in medicated feedingstuffs which have been manufactured in accordance with the requirements of this Directive, and in particular Article 4 thereof, with authorized pre-mixes which have the same active substances as pre-mixes authorized by the Member State of destination, in accordance with the criteria of Directive 81/852/EEC, and a quantitative and qualitative composition similar thereto, — subject to the specific provisions of Council Directive 86/469/EEC of 16 September 1986 concerning the examination of animals and fresh meat for the presence of residues (12) and Council Directive 88/299/EEC of 17 May 1988 on trade in animals treated with certain substances having a hormonal action and their meat, as referred to in Article 7 of Directive 88/146/EEC (13), in animals to which those medicated feedingstuffs except those produced pursuant to the second subparagraph of Article 3 (1), have been administered, or in meat, flesh, offal or their products from such animals. 2. Where the application of paragraph 1 gives rise to dispute, in particular as concerns recognition of the similar nature of the pre-mix, the Member States concerned or the Commission may submit the dispute to assessment by an expert appearing on a list of Community experts to be drawn up by the Commission on a proposal from the Member States. If the two Member States so agree beforehand, the parties shall abide by the opinion of the expert, in compliance with Community legislation. 3. The Member State of destination may require that each consignment of a medicated feedingstuff be accompanied by a certificate issued by the competent authority, corresponding to the specimen form in Annex B. Article 11 1. The safeguard measures laid down by Directive 89/662/EEC shall apply to trade in authorized medicated pre-mixes or medicated feedingstuffs. 2. The rules laid down concerning veterinary control and, in particular, the requirements laid down in Article 5 (2) and Article 20 of Directive 89/662/EEC shall apply to trade in authorized pre-mixes or medicated feedingstuffs to the extent that they are subject to veterinary control. Article 12 The Council, acting by a qualified majority on proposals from the Commission, shall adopt any amendments and additions to be made to this Directive. Article 13 Member States shall take all necessary measures to ensure that their competent authorities satisfy themselves: (i) by making sampling checks at all stages of the production and marketing of the products referred to by this Directive, that the provisions of this Directive are complied with; (ii) in particular, by making sampling checks on farms and slaughterhouses, that medicated feedingstuffs are used in compliance with the conditions of use, and that withdrawal periods have been complied with. Article 14 Pending the implementation of Community measures relating to imports of medicated feedingstuffs from third countries, Member States shall apply to those imports measures which are at least equivalent to those of this Directive. Article 15 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply: — with the requirements of Article 11 (2) on the date on which they must conform with the Community rules on the protection of feedingstuffs against pathogenic agents, but at the latest by 31 December 1992, — before 1 October 1991, with the other provisions of this Directive. They shall forthwith inform the Commission thereof. Article 16 This Directive is addressed to the Member States.

31990L0207

1990

Commission Directive 90/207/EEC of 4 April 1990 amending the Second Directive 82/434/EEC on the approximation of the laws of the Member State relating to methods of analysis necessary for checking the composition of cosmetic products Having regard to the Treaty establishing the European Economic Community, Whereas Second Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the laws of the Member States relating to methods of analysis for checking the composition of cosmetic products (1) lays down a common method of analysis for the identification and determination of free formaladehyde; Whereas, in the light of new scientific and technical data, it has proved to be necessary to amend this method of analysis; Whereas the measures provided for in this Directive are in conformity 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 Chapter IV of the Annex to Directive 82/434/EEC shall be replaced by the text 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 not later than 31 December 1990. They shall forthwith inform the Commission thereof. The provisions adopted under the first paragraph shall refer expressly to this Directive. Article 3 This Directive is addressed to the Member States.

31990L0219

1990

Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms 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, under the Treaty, action by the Community relating to the environment shall be based on the principle that preventive action shall be taken and shall have as its objective to preserve, protect and improve the environment and to protect human health; Whereas the Council Resolution of 19 October 1987 (4) concerning the Fourth Environmental Action Programme of the European Communities declares that measures concerning the evaluation and best use of biotechnology with regard to the environment are a priority area on which Community action should concentrate; Whereas the development of biotechnology is such as to contribute to the economic expansion of the Member States; whereas this implies that genetically modified micro-organisms will be used in operations of various types and scale; OJ No C 246, 27. 9. 1989, p. 6. OJ No C 96, 17. 4. 1990. Whereas the contained use of genetically modified micro-organisms should be carried out in such way as to limit their possible negative consequences for human health and the environment, due attention being given to the prevention of accidents and the control of wastes; Whereas micro-organisms, if released in the environment in one Member State in the course of their contained use, may reproduce and spread, crossing national frontiers and thereby affecting other Member States; Whereas, in order to bring about the safe development of biotechnology throughout the Community, it is necessary to establish common measures for the evaluation and reduction of the potential risks arising in the course of all operations involving the contained use of genetically modified micro-organisms and to set appropriate conditions of use; Whereas the precise nature and scale of risks associated with genetically modified micro-organisms are not yet fully known and the risk involved must be assessed case by case; whereas, to evaluate risk for human health and the environment, it is necessary to lay down requirements for risk assessment; Whereas genetically modified micro-organisms should be classified in relation to the risks they present; whereas criteria should be provided for this purpose; whereas particular attention should be given to operations using the more hazardous genetically modified micro-organisms; Whereas appropriate containment measures should be applied at the various stages of an operation to control emissions and to prevent accidents; Whereas any person, before undertaking for the first time the contained use of a genetically modified micro-organism in a particular installation, should forward to the competent authority a notification so that the authority may satisfy itself that the proposed installation is appropriate to carry out the activity in a manner that does not present a hazard to human health and the environment; Whereas it is also necessary to establish appropriate procedures for the case-by-case notification of specific operations involving the contained use of genetically modified micro-organisms, taking account of the degree of risk involved; Whereas, in the case of operations involving high risk, the consent of the competent authority should be given; Whereas it may be considered appropriate to consult the public on the contained use of genetically modified micro-organisms; Whereas appropriate measures should be taken to inform any person liable to be affected by an accident on all matters relating to safety; Whereas emergency plans should be established to deal effectively with accidents; Whereas, if an accident occurs, the user should immediately inform the competent authority and communicate the information necessary for assessing the impact of that accident and for taking the appropriate action; Whereas it is appropriate for the Commission, in consultation with the Member States, to establish a procedure for the exchange of information on accidents and for the Commission to set up a register of such accidents; Whereas the contained use of genetically modified micro-organisms throughout the Community should be monitored and to this end Member States should supply certain information to the Commission; Whereas a committee should be set up to assist the Commission on matters relating to the implementation of this Directive and to its adaptation to technical progress, Article 1 This Directive lays down common measures for the contained use of genetically modified micro-organisms with a view to protecting human health and the environment. Article 2 For the purposes of this Directive: (a) 'micro-organism' shall mean any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material; (b) 'genetically modified micro-organism' shall mean a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination. Within the terms of this definition: i(i) genetic modification occurs at least through the use of the techniques listed in Annex I A, Part 1; (ii) the techniques listed in Annex I A, Part 2, are not considered to result in genetic modification; (c) 'contained use' shall mean any operation in which micro-organisms are genetically modified or in which such genetically modified micro-organisms are cultured, stored, used, transported, destroyed or disposed of and for which physical barriers, or a combination of physical barriers together with chemical and/or biological barriers, are used to limit their contact with the general population and the environment; (d) Type A operation shall mean any operation used for teaching, research, development, or non-industrial or non-commercial purposes and which is of a small scale (e.g. 10 litres culture volume or less); (e) Type B operation shall mean any operation other than a Type A operation; (f) 'accident' shall mean any incident involving a significant and unintended release of genetically modified micro-organisms in the course of their contained use which could present an immediate or delayed hazard to human health or the environment; (g) 'user' shall mean any natural or legal person responsible for the contained use of genetically modified micro-organisms; (h) 'notification' shall mean the presentation of documents containing the requisite information to the competent authorities of a Member State. Article 3 This Directive shall not apply where genetic modification is obtained through the use of the techniques listed in Annex I B. Article 4 1. For the purposes of this Directive, genetically modified micro-organisms shall be classified as follows: Group II: those satisfying the criteria of Annex II; Group II: those other than in Group I. 2. For Type A operations, some of the criteria in Annex II may not be applicable in determining the classification of a particular genetically modified micro-organism. In such a case, the classification shall be provisional and the competent authority shall ensure that relevant criteria are used with the aim of obtaining equivalence as far as possible. 3. Before this Directive is implemented, the Commission shall draw up guidelines for classification under the procedures of Article 21. Article 5 Articles 7 to 12 shall not apply to the transport of genetically modified micro-organisms by road, rail, inland waterway, sea or air. This Directive shall not apply to the storage, transport, destruction or disposal of genetically modified micro-organisms which have been placed on the market under Community legislation, which includes a specific risk assessment similar to that provided in this Directive. Article 6 1. Member States shall ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the contained use of genetically modified micro-organisms. 2. To this end, the user shall carry out a prior assessment of the contained uses as regards the risks to human health and the environment that they may incur. 3. In making such an assessment the user shall, in particular, take due account of the parameters set out in Annex III, as far as they are relevant, for any genetically modified micro-organisms he is proposing to use. 4. A record of this assessment shall be kept by the user and made available in summary form to the competent authority as part of the notification under Articles 8, 9 and 10 or upon request. Article 7 1. For genetically modified micro-organisms in Group I, principles of good microbiological practice, and the following principles of good occupational safety and hygiene, shall apply: iii(i) to keep workplace and environmental exposure to any physical, chemical or biological agent to the lowest practicable level; ii(ii) to exercise engineering control measures at source and to supplement these with appropriate personal protective clothing and equipment when necessary; i(iii) to test adequately and maintain control measures and equipment; i(iv) to test, when necessary, for the presence of viable process organisms outside the primary physical containment; ii(v) to provide training of personnel; i(vi) to establish biological safety committees or subcommittees as required; (vii) to formulate and implement local codes of practice for the safety of personnel. 2. In addition to these principles, the containment measures set out in Annex IV shall be applied, as appropriate, to contained uses of genetically modified micro-organisms in Group II so as to ensure a high level of safety. 3. The containment measures applied shall be periodically reviewed by the user to take into account new scientific or technical knowledge relative to risk management and treatment and disposal of wastes. Article 8 When a particular installation is to be used for the first time for operations involving the contained use of genetically modified micro-organisms, the user shall be required to submit to the competent authorities, before commencing such use, a notification containing at least the information listed in Annex V A. A separate notification shall be made for first use of genetically modified micro-organisms in Group I and Group II respectively. Article 9 1. Users of genetically modified micro-organisms classified in Group I in Type A operations shall be required to keep records of the work carried out which shall be made available to the competent authority on request. 2. Users of genetically modified micro-organisms classified in Group I in Type B operations shall, before commencing the contained use, be required to submit to the competent authorities a notification containing the information listed in Annex V B. Article 10 1. Users of genetically modified micro-organisms classified in Group II in Type A operations shall, before commencing the contained use, be required to submit to the competent authorities a notification containing the information listed in Annex V C. 2. Users of genetically modified micro-organisms classified in Group II in Type B operations shall, before commencing the contained use, be required to submit to the competent authorities a notification containing: - information on the genetically modified micro-organism(s), - information on personnel and training; - information on the installation, - information on waste management, - information on accident prevention and emergency response plans, - the assessment of the risks to human health and the environment referred to in Article 6, the details of which are listed in Annex V D. Article 11 1. Member States shall designate the authority or authorities competent to implement the measures which they adopt in application of this Directive and to receive and acknowledge the notifications referred to in Article 8, Article 9 (2) and Article 10. 2. The competent authorities shall examine the conformity of the notifications with the requirements of this Directive, the accuracy and completeness of the information given, the correctness of the classification and, where appropriate, the adequacy of the waste management, safety, and emergency response measures. 3. If necessary, the competent authority may: (a) ask the user to provide further information or to modify the conditions of the proposed contained use. In this case the proposed contained use cannot proceed until the competent authority has given its approval on the basis of the further information obtained or of the modified conditions of the contained use; (b) limit the time for which the contained use should be permitted or subject it to certain specific conditions. 4. In the case of first-time use in an installation as referred to in Article 8: - where such use involves genetically modified micro-organisms in Group I, the contained use may, in the absence of any indication to the contrary from the competent authority, proceed 90 days after submission of the notification, or earlier with the agreement of the competent authority; - where such use involves genetically modified micro-organisms in Group II, the contained use may not proceed without the consent of the competent authority. The competent authority shall communicate its decision in writing at the latest 90 days after submission of the notification. 5. (a) Operations notified under Article 9 (2) and Article 10 (1), may, in the absence of any indication to the contrary from the competent authority, proceed 60 days after submission of the notification, or earlier with the agreement of the competent authority. (b) Operations notified under Article 10 (2) may not proceed without the consent of the competent authority. The competent authority shall communicate its decision in writing at the latest 90 days after submission of the notification. 6. For the purpose of calculating the periods referred to in paragraphs 4 and 5, any periods of time during which the competent authority: - is awaiting any further information which it may have requested from the notifier in accordance with paragraph 3 (a) or - is carrying out a public inquiry or consultation in accordance with Article 13 shall not be taken into account. Article 12 1. If the user becomes aware of relevant new information or modifies the contained use in a way which could have significant consequences for the risks posed by the contained use, or if the category of genetically modified micro-organisms used is changed, the competent authority shall be informed as soon as possible and the notification under Articles 8, 9 and 10 modified. 2. If information becomes available subsequently to the competent authority which could have significant consequences for the risks posed by the contained use, the competent authority may require the user to modify the conditions of, suspend or terminate the contained use. Article 13 Where a Member State considers it appropriate, it may provide that groups or the public shall be consulted on any aspect of the proposed contained use. Article 14 The competent authorities shall ensure that, where necessary, before an operation commences: (a) an emergency plan is drawn up for the protection of human health and the environment outside the installation in the event of an accident and the emergency services are aware of the hazards and informed thereof in writing; (b) information on safety measures and on the correct behaviour to adopt in the case of an accident is supplied in an appropriate manner, and without their having to request it, to persons liable to be affected by the accident. The information shall be repeated and updated at appropriate intervals. It shall also be made publicly available. The Member States concerned shall at the same time make available to other Member States concerned, as a basis for all necessary consultation within the framework of their bilateral relations, the same information as that which is disseminated to their nationals. Article 15 1. Member States shall take the necessary measures to ensure that, in the event of an accident, the user shall be required immediately to inform the competent authority specified in Article 11 and provide the following information: - the circumstances of the accident, - the identity and quantities of the genetically modified micro-organisms released, - any information necessary to assess the effects of the accident on the health of the general population and the environment, - the emergency measures taken. 2. Where information is given under paragraph 1, the Member States shall be required to: - ensure that any emergency, medium and long-term measures necessary are taken, and immediately alert any Member State which could be affected by the accident; - collect, where possible, the information necessary for a full analysis of the accident and, where appropriate, make recommendations to avoid similar accidents in the future and to limit the effects thereof. Article 16 1. Member States shall be required to: (a) consult with other Member States liable to be affected in the event of an accident in the drawing up and implementation of emergency plans; (b) inform the Commission as soon as possible of any accident within the scope of this Directive, giving details of the circumstances of the accident, the identity and quantities of the genetically modified micro-organisms released, the emergency response measures employed and their effectiveness, and an analysis of the accident including recommendations to limit its effects and avoid similar accidents in the future. 2. The Commission, in consultation with the Member States, shall establish a procedure for the exchange of information under paragraph 1. It shall also set up and keep at the disposal of the Member States a register of accidents within the scope of this Directive which have occurred, including an analysis of the causes of the accidents, experience gained and measures taken to avoid similar accidents in the future. Article 17 Member States shall ensure that the competent authority organizes inspections and other control measures to ensure user compliance with this Directive. Article 18 1. Member States shall send to the Commission, at the end of each year, a summary report on the contained uses notified under Article 10 (2) including the description, proposed uses and risks of the genetically modified micro-organisms. 2. Every three years, Member States shall send the Commission a summary report on their experience with this Directive, the first time being on 1 September 1992. 3. Every three years, the Commission shall publish a summary based on the reports referred to in paragraph 2, the first time being in 1993. 4. The Commission may publish general statistical information on the implementation of this Directive and related matters, as long as it contains no information likely to cause harm to the competitive position of a user. Article 19 1. The Commission and the competent authorities shall not divulge to third parties any confidential information notified or otherwise provided under this Directive and shall protect intellectual property rights relating to the data received. 2. The notifier may indicate the information in the notifications submitted under this Directive, the disclosure of which might harm his competitive position, that should be treated as confidential. Verifiable justification must be given in such cases. 3. The competent authority shall decide, after consultation with the notifier, which information will be kept confidential and shall inform the notifier of its decision. 4. In no case may the following information, when submitted according to Articles 8, 9 or 10, be kept confidential: - description of the genetically modified micro-organisms, name and address of the notifier, purpose of the contained use, and location of use; - methods and plans for monitoring of the genetically modified micro-organisms and for emergency response; - the evaluation of foreseeable effects, in particular any pathogenic and/or ecologically disruptive effects. 5. If, for whatever reasons, the notifier withdraws the notification, the competent authority must respect the confidentiality of the information supplied. Article 20 Amendments necessary to adapt Annexes II to V to technical progress shall be decided in accordance with the procedure defined in Article 21. Article 21 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. (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 not later than 23 October 1991. They shall forthwith inform the Commission thereof. Article 23 This Directive is addressed to the Member States.

31990L0220

1990

Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms 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, under the Treaty, action by the Community relating to the environment should be based on the principle that preventive action should be taken; Whereas living organisms, whether released into the environment in large or small amounts for experimental purposes or as commercial products, may reproduce in the environment and cross national frontiers thereby affecting other Member States; whereas the effects of such releases on the environment may be irreversible; Whereas the protection of human health and the environment requires that due attention be given to controlling risks from the deliberate release of genetically modified organisms (GMOs) into the environment; Whereas disparity between the rules which are in effect or in preparation in the Member States concerning the deliberate release into the environment of GMOs may create unequal conditions of competition or barriers to trade in products containing such organisms, thus affecting the functioning of the common market; whereas it is therefore necessary to approximate the laws of the Member States in this respect; 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 should, inasmuch as they concern health, safety, environmental and consumer protection, be based on a high level of protection throughout the Community; Whereas it is necessary to ensure the safe development of industrial products utilizing GMOs; OJ No C 246, 27. 9. 1989, p. 5. OJ No C 96, 17. 4. 1990. Whereas this Directive should not apply to organisms obtained through certain techniques of genetic modification which have conventionally been used in a number of applications and have a long safety record; Whereas it is necessary to establish harmonized procedures and criteria for the case-by-case evaluation of the potential risks arising from the deliberate release of GMOs into the environment; Whereas a case-by-case environmental risk assessment should always be carried out prior to a release; Whereas the deliberate release of GMOs at the research stage is in most cases a necessary step in the development of new products derived from, or containing, GMOs; Whereas the introduction of GMOs into the environment should be carried out according to the 'step by step' principle; whereas this means that the containment of GMOs is reduced and the scale of release increased gradually, step by step, but only if evaluation of the earlier steps in terms of protection of human health and the environment indicates that the next step can be taken; Whereas no product containing, or consisting of, GMOs and intended for deliberate release shall be considered for placing on the market without it first having been subjected to satisfactory field testing at the research and development stage in ecosystems which could be affected by its use; Whereas it is necessary to establish a Community authorization procedure for the placing on the market of products containing, or consisting of, GMOs where the intended use of the product involves the deliberate release of the organism(s) into the environment; Whereas any person, before undertaking a deliberate release into the environment of a GMO, or the placing on the market of a product containing, or consisting of, GMOs, where the intended use of that product involves its deliberate release into the environment, shall submit a notification to the national competent authority; Whereas that notification should contain a technical dossier of information including a full environmental risk assessment, appropriate safety and emergency response, and, in the case of products, precise instructions and conditions for use, and proposed labelling and packaging; Whereas, after notification, no deliberate release of GMOs should be carried out unless the consent of the competent authority has been obtained; Whereas the competent authority should give its consent only after it has been satisfied that the release will be safe for human health and the environment; Whereas it may be considered appropriate in certain cases to consult the public on the deliberate release of GMOs into the environment; Whereas it is appropriate for the Commission, in consultation with the Member States, to establish a procedure for the exchange of information on deliberate releases of GMOs notified under this Directive; Whereas it is important to follow closely the development and use of GMOs; whereas a list should be published of all the products authorized under this Directive; Whereas, when a product containing a GMO or a combination of GMOs is placed on the market, and where such a product has been properly authorized under this Directive, a Member State may not on grounds relating to matters covered by this Directive, prohibit, restrict or impede the deliberate release of the organism in that product on its territory where the conditions set out in the consent are respected; whereas a safeguard procedure should be provided in case of risk to human health or the environment; Whereas the provisions of this Directive relating to placing on the market of products should not apply to products containing, or consisting of, GMOs covered by other Community legislation which provides for a specific environmental risk assessment similar to that laid down in this Directive; Whereas a Committee should be set up to assist the Commission on matters relating to the implementation of this Directive and to its adaptation to technical progress, PART A General provisions Article 1 1. The objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment: - when carrying out the deliberate release of genetically modified organisms into the environment, - when placing on the market products containing, or consisting of, genetically modified organisms intended for subsequent deliberate release into the environment. 2. This Directive shall not apply to the carriage of genetically modified organisms by rail, road, inland waterway, sea or air. Article 2 For the purposes of this Directive: (1) 'organism' is any biological entity capable of replication or of transferring genetic material; (2) 'genetically modified organism (GMO)' means an organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination. Within the terms of this definition: i(i) genetic modification occurs at least through the use of the techniques listed in Annex I A Part 1; (ii) the techniques listed in Annex I A Part 2 are not considered to result in genetic modification; (3) 'deliberate release' means any intentional introduction into the environment of a GMO or a combination of GMOs without provisions for containment such as physical barriers or a combination of physical barriers together with chemical and/or biological barriers used to limit their contact with the general population and the environment; (4) 'product' means a preparation consisting of, or containing, a GMO or a combination of GMOs, which is placed on the market; (5) 'placing on the market' means supplying or making available to third parties; (6) 'notification' means the presentation of documents containing the requisite information to the competent authority of a Member State. The person making the presentation shall be referred to as 'the notifier'; (7) 'use' means the deliberate release of a product which has been placed on the market. The persons carrying out this use will be referred to as 'users'; (8) 'environmental risk assessment' means the evaluation of the risk to human health and the environment (which includes plants and animals) connected with the release of GMOs or products containing GMOs. Article 3 This Directive shall not apply to organisms obtained through the techniques of genetic modification listed in Annex I B. Article 4 1. Member States shall ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or placing on the market of GMOs. 2. Member States shall designate the competent authority or authorities responsible for carrying out the requirements of this Directive and its Annexes. 3. Member States shall ensure that the competent authority organizes inspections and other control measures as appropriate, to ensure compliance with this Directive. PART B Deliberate release of GMOs into the environment for research and development purposes or for any other purpose than for placing on the market Article 5 Member States shall adopt the provisions necessary to ensure that: (1) any person, before undertaking a deliberate release of a GMO or a combination of GMOs for the purpose of research and development, or for any other purpose than for placing on the market, must submit a notification to the competent authority referred to in Article 4 (2) of the Member State within whose territory the release is to take place; (2) the notification shall include: (a) a technical dossier supplying the information specified in Annex II necessary for evaluating the foreseeable risks, whether immediate or delayed, which the GMO or combination of GMOs may pose to human health or the environment, together with the methods used and the bibliographic reference to them and covering, in particular: ii(i) general information including information on personnel and training, i(ii) information relating to the GMO(s), (iii) information relating to the conditions of release and the receiving environment, (iv) information on the interactions between the GMO(s) and the environment, i(v) information on monitoring, control, waste treatment and emergency response plans; (b) a statement evaluating the impacts and risks posed by the GMO(s) to human health or the environment from the uses envisaged; (3) the competent authority may accept that releases of a combination of GMOs on the same site or of the same GMO on different sites for the same purpose and within a limited period may be notified in a single notification; (4) the notifier shall include in the notification information on data or results from releases of the same GMOs or the same combination of GMOs previously or currently notified and/or carried out by him either inside or outside the Community. The notifier may also refer to data or results from notifications previously submitted by other notifiers, provided that the latter have given their agreement in writing; (5) in the case of a subsequent release of the same GMO or combination of GMOs previously notified as part of the same research programme, the notifier shall be required to submit a new notification. In this case, the notifier may refer to data from previous notifications or results from previous releases; (6) in the event of any modification of the deliberate release of GMOs or a combination of GMOs which could have consequences with regard to the risks for human health or the environment or if new information has become available on such risks, either while the notification is being examined by the competent authority or after that authority has given its written consent, the notifier shall immediately: (a) revise the measures specified in the notification, (b) inform the competent authority in advance of any modification or as soon as the new information is available, (c) take the measures necessary to protect human health and the environment. Article 6 1. On receipt and after acknowledgment of the notification the competent authority shall: - examine it for compliance with this Directive, - evaluate the risks posed by the release, - record its conclusions in writing, and, if necessary, - carry out tests or inspections as may be necessary for control purposes. 2. The competent authority, having considered, where appropriate, any comments by other Member States made in accordance with Article 9, shall respond in writing to the notifier within 90 days of receipt of the notification by either: (a) indicating that it is satisfied that the notification is in compliance with this Directive and that the release may proceed, or (b) indicating that the release does not fulfil the conditions of this Directive and the notification is therefore rejected. 3. For the purpose of calculating the 90-day period referred to in paragraph 2, any periods of time during which the competent authority: - is awaiting further information which it may have requested from the notifier, or - is carrying out a public inquiry or consultation in accordance with Article 7 shall not be taken into account. 4. The notifier may proceed with the release only when he has received the written consent of the competent authority, and in conformity with any conditions required in this consent. 5. If the competent authority considers that sufficient experience has been obtained of releases of certain GMOs, it may submit to the Commission a request for the application of simplified procedures for releases of such types of GMOs. The Commission shall, in accordance with the procedures laid down in Article 21, establish appropriate criteria and take a decision accordingly on each application. The criteria shall be based on safety to human health and the environment and on the evidence available on such safety. 6. If information becomes available subsequently to the competent authority which could have significant consequences for the risks posed by the release, the competent authority may require the notifier to modify the conditions of, suspend or terminate the deliberate release. Article 7 Where a Member State considers it appropriate, it may provide that groups or the public shall be consulted on any aspect of the proposed deliberate release. Article 8 After completion of a release, the notifier shall send to the competent authority the result of the release in respect of any risk to human health or the environment, with particular reference to any kind of product that the notifier intends to notify at a later stage. Article 9 1. The Commission shall set up a system of exchange of the information contained in the notifications. The competent authorities shall send to the Commission, within 30 days of its receipt, a summary of each notification received. The format of this summary will be established by the Commission in accordance with the procedure laid down in Article 21. 2. The Commission shall immediately forward these summaries to the other Member States, which may, within 30 days, ask for further information or present observations through the Commission or directly. 3. The competent authorities shall inform the other Member States and the Commission of the final decisions taken in compliance with Article 6 (2). PART C Placing on the market of products containing GMOs Article 10 1. Consent may only be given for the placing on the market of products containing, or consisting of, GMOs, provided that: - written consent has been given to a notification under Part B or if a risk analysis has been carried out based on the elements outlined in that Part; - the products comply with the relevant Community product legislation; - the products comply with the requirements of this Part of this Directive, concerning the environmental risk assessment. 2. Articles 11 to 18 shall not apply to any products covered by Community legislation which provides for a specific environmental risk assessment similar to that laid down in this Directive. 3. Not later than 12 months after notification of this Directive, the Commission, in accordance with the procedure laid down in Article 21, shall establish a list of Community legislation covering the products referred to in paragraph 2. This list will be re-examined periodically and, as necessary, revised in accordance with the said procedure. Article 11 1. Before a GMO or a combination of GMOs are placed on the market as or in a product, the manufacturer or the importer to the Community shall submit a notification to the competent authority of the Member State where such a product is to be placed on the market for the first time. This notification shall contain: - the information required in Annex II, extended as necessary to take into account the diversity of sites of use of the product, including information on data and results obtained from research and developmental releases concerning the ecosystems which could be affected by the use of the product and an assessent of any risks for human health and the environment related to the GMOs or a combination of GMOs contained in the product, including information obtained from the research and development stage on the impact of the release on human health and the environment; - the conditions for the placing on the market of the product, including specific conditions of use and handling and a proposal for labelling and packaging which should comprise at least the requirements laid down in Annex III. If on the basis of the results of any release notified under Part B of this Directive, or on substantive, reasoned scientific grounds, a notifier considers that the placing on the market and use of a product do not pose a risk to human health and the environment, he may propose not to comply with one or more of the requirements of Annex III B. 2. The notifier shall include in this notification information on data or results from releases of the same GMOs or the same combination of GMOs previously or currently notified and/or carried out by the notifier either inside or outside the Community. 3. The notifier may also refer to data or results from notifications previously submitted by other notifiers, provided that the latter have given their agreement in writing. 4. Each new product which, containing or consisting of the same GMO or combination of GMOs, is intended for a different use, shall be notified separately. 5. The notifier may proceed with the release only when he has received the written consent of the competent authority in accordance with Article 13, and in conformity with any conditions, including reference to particular ecosystems/environments, required in that consent. 6. If new information has become available with regard to the risks of the product to human health or the environment, either before or after the written consent, the notifier shall immediately: - revise the information and conditions specified in paragraph 1, - inform the competent authority, and - take the measures necessary to protect human health and the environment. Article 12 1. On receipt and after acknowledgement of the notification referred to in Article 11, the competent authority shall examine it for compliance with this Directive, giving particular attention to the environmental risk assessment and the recommended precautions related to the safe use of the product. 2. At the latest 90 days after receipt of the notification, the competent authority shall either: (a) forward the dossier to the Commission with a favourable opinion, or (b) inform the notifier that the proposed release does not fulfil the conditions of this Directive and that it is therefore rejected. 3. In the case referred to in paragraph 2 (a), the dossier forwarded to the Commission shall include a summary of the notification together with a statement of the conditions under which the competent authority proposes to consent to the placing on the market of the product. The format of this summary shall be established by the Commission in accordance with the procedure laid down in Article 21. In particular where the competent authority has acceded to the request of the notifier, under the terms of the last subparagraph of Article 11 (1), not to comply with some of the requirements of Annex III B, it shall at the same time inform the Commission thereof. 4. If the competent authority receives additional information pursuant to Article 11 (6), it shall immediately inform the Commission and the other Member States. 5. For the purpose of calculating the 90-day period referred to in paragraph 2, any periods of time during which the competent authority is awaiting further information which it may have requested from the notifier shall not be taken into account. Article 13 1. On receipt of the dossier referred to in Article 12 (3), the Commission shall immediately forward it to the competent authorities of all Member States together with any other information it has collected pursuant to this Directive and advise the competent authority responsible for forwarding the document of the distribution date. 2. The competent authority, in the absence of any indication to the contrary from another Member State within 60 days following the distribution date referred to in paragraph 1, shall give its consent in writing to the notification so that the product can be placed on the market and shall inform the other Member States and the Commission thereof. 3. In cases where the competent authority of another Member State raises an objection - for which the reasons must be stated - and should it not be possible for the competent authorities concerned to reach an agreement within the period specified in paragraph 2, the Commission shall take a decision in accordance with the procedure laid down in Article 21. 4. Where the Commission has taken a favourable decision, the competent authority that received the original notification shall give consent in writing to the notification so that the product may be placed on the market and shall inform the other Member States and the Commission thereof. 5. Once a product has received a written consent, it may be used without further notification throughout the Community in so far as the specific conditions of use and the environments and/or geographical areas stipulated in these conditions are strictly adhered to. 6. Member States shall take all necessary measures to ensure that users comply with the conditions of use specified in the written consent. Article 14 Member States shall take all necessary measures to ensure that products containing, or consisting of, GMOs will be placed on the market only if their labelling and packaging is that specified in the written consent referred to in Articles 12 and 13. Article 15 Member States may not, on grounds relating to the notification and written consent of a deliberate release under this Directive, prohibit, restrict or impede the placing on the market of products containing, or consisting of, GMOs which comply with the requirements of this Directive. Article 16 1. Where a Member State has justifiable reasons to consider that a product which has been properly notified and has received written consent under this Directive constitutes a risk to human health or the environment, it may provisionally restrict or prohibit the use and/or sale of that product on its territory. It shall immediately inform the Commission and the other Member States of such action and give reasons for its decision. 2. A decision shall be taken on the matter within three months in accordance with the procedure laid down in Article 21. Article 17 The Commission shall publish in the Official Journal of the European Communities a list of all the products receiving final written consent under this Directive. For each product, the GMO or GMOs contained therein and the use or uses shall be clearly specified. Article 18 1. Member States shall send to the Commission, at the end of each year, a brief factual report on the control of the use of all products placed on the market under this Directive. 2. The Commission shall send to the European Parliament and the Council, every three years, a report on the control by the Member States of the products placed on the market under this Directive. 3. When submitting this report for the first time, the Commission shall at the same time submit a specific report on the operation of this Part of this Directive including an assessment of all its implications. PART D Final provisions Article 19 1. The Commission and the competent authorities shall not divulge to third parties any confidential information notified or exchanged under this Directive and shall protect intellectual property rights relating to the data received. 2. The notifier may indicate the information in the notification submitted under this Directive, the disclosure of which might harm his competitive position, that should therefore be treated as confidential. Verifiable justification must be given in such cases. 3. The competent authority shall decide, after consultation with the notifier, which information will be kept confidential and shall inform the notifier of its decisions. 4. In no case may the following information when submitted according to Articles 5 or 11 be kept confidential: - description of the GMO or GMOs, name and address of the notifier, purpose of the release and location of release; - methods and plans for monitoring of the GMO or GMOs and for emergency response; - the evaluation of foreseeable effects, in particular any pathogenic and/or ecologically disruptive effects. 5. If, for whatever reasons, the notifier withdraws the notification, the competent authorities and the Commission must respect the confidentiality of the information supplied. Article 20 According to the procedure laid down in Article 21, the Commission shall adapt Annexes II and III to technical progress in particular by amending the notification requirements to take into account the potential hazard of the GMOs. Article 21 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 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. Article 22 1. Member States and the Commission shall meet regularly and exchange information on the experience acquired with regard to the prevention of risks related to the release of GMOs into the environment. 2. Every three years, Member States shall send the Commission a report on the measures taken to implement the provisions of this Directive, the first time being on 1 September 1992. 3. Every three years, the Commission shall publish a summary based on the reports referred to in paragraph 2, the first time being in 1993. Article 23 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 23 October 1991. 2. Member States shall immediately inform the Commission of all laws, regulations and administrative provisions adopted in implementation of this Directive. Article 24 This Directive is addressed to the Member States.

31990L0232

1990

Third Council Directive 90/232/EEC of 14 May 1990 on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use 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, by Directive 72/166/EEC (4), as last amended by Directive 84/5/EEC (5), the Council adopted provisions on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles and to the enforcement of the obligation to insure against such liability; Whereas Article 3 of Directive 72/166/EEC requires each Member State to take all appropriate measures to ensure that civil liability in respect of the use of vehicles normally based in its territory is covered by insurance; whereas the extent of the liability covered and the terms and conditions of the insurance cover should be determined on the basis of those measures; Whereas Directive 84/5/EEC, as amended by the Act of Accession of Spain and Portugal, reduced considerably the disparities between the level and content of compulsory civil liability insurance in the Member States; whereas significant disparities still exist, however, in such insurance cover; Whereas motor vehicle accident victims should be guaranteed comparable treatment irrespective of where in the Community accidents occur; Whereas there are, in particular, gaps in the compulsory insurance cover of motor vehicle passengers in certain Member States; whereas, to protect this particularly vulnerable category of potential victims, such gaps should be filled; Whereas any uncertainty concerning the application of the first indent of Article 3 (2) of Directive 72/166/EEC should be removed; whereas all compulsory motor insurance policies must cover the entire territory of the Community; Whereas in the interests of the party insured, every insurance policy should, moreover, guarantee for a single premium, in each Member State, the cover required by its law or the cover required by the law of the Member State where the vehicle is normally based, when that cover is higher; Whereas Article 1 (4) of Directive 84/5/EEC requires each Member State to set up or authorize a body to compensate the victims of accidents caused by uninsured or unidentified vehicles; whereas, however, the said provision is without prejudice to the right of the Member States to regard compensation by this body as subsidiary or non-subsidiary; Whereas, however, in the case of an accident caused by an uninsured vehicle, the victim is required in certain Member States to prove that the party liable is unable or refuses to pay compensation before he can claim on the body; whereas this body is better placed than the victim to bring an action against the party liable; whereas, therefore, this body should be prevented from being able to require that the victim, if he is to be compensated, should establish that the party liable is unable or refuses to pay; Whereas, in the event of a dispute between the body referred to above and a civil liability insurer as to which of them should compensate the victim of an accident, Member States, to avoid any delay in the payment of compensation to the victim, should ensure that one of these parties is designated to be responsible in the first instance for paying compensation pending resolution of the dispute; Whereas motor vehicle accident victims sometimes have difficulties in finding out the name of the insurance undertaking covering the liability arising out of the use of a motor vehicle involved in an accident; whereas, in the interests of such victims, Member States should take the necessary measures to ensure that such information is made available promptly; Whereas the previous two Directives on civil liability in respect of motor vehicles should, in view of all these considerations, be supplemented in a uniform manner; Whereas such an addition, which leads to greater protection for the parties insured and for the victims of accidents, will facilitate still further the crossing of internal Community frontiers and hence the establishment and functioning of the internal market; whereas, therefore, a high level of consumer protection should be taken as a basis; Whereas, under the terms of Article 8c of the Treaty, account should be taken of the extent of the effort which must be made by certain economies which show differences in development; whereas certain Member States should, therefore, be granted transitional arrangements so that certain provisions of this Directive may be implemented gradually, Article 1 Without prejudice to the second subparagraph of Article 2 (1) of Directive 84/5/EEC, the insurance referred to in Article 3 (1) of Directive 72/166/EEC shall cover liability for personal injuries to all passengers, other than the driver, arising out of the use of a vehicle. For the purposes of this Directive, the meaning of the term 'vehicle' is as defined in Article 1 of Directive 72/166/EEC. Article 2 Member States shall take the necessary steps to ensure that all compulsory insurance policies against civil liability arising out of the use of vehicles: - cover, on the basis of a single premium, the entire territory of the Community, and - guarantee, on the basis of the same single premium, in each Member State, the cover required by its law or the cover required by the law of the Member State where the vehicle is normally based when that cover is higher. Article 3 The following sentence shall be added to the first subparagraph of Article 1 (4) of Council Directive 84/5/EEC: 'However, Member States may not allow the body to make the payment of compensation conditional on the victim's establishing in any way that the person liable is unable or refuses to pay.' Article 4 In the event of a dispute between the body referred to in Article 1 (4) of Directive 84/5/EEC and the civil liability insurer as to which must compensate the victim, the Member States shall take the appropriate measures so that one of these parties is designated to be responsible in the first instance for paying compensation to the victim without delay. If it is ultimately decided that the other party should have paid all or part of the compensation, that other party shall reimburse accordingly the party which has paid. Article 5 1. Member States shall adopt the necessary measures to ensure that the parties involved in a road traffic accident are able to ascertain promptly the identity of the insurance undertaking covering the liability arising out of the use of any motor vehicle involved in the accident. 2. Not later than 31 December 1995, the Commission shall present to the European Parliament and the Council a report on the implementation of paragraph 1 of this Article. Where necessary, the Commission shall submit appropriate proposals to the Council. Article 6 1. Member States shall take the measures necessary to comply with this Directive not later than 31 December 1992. They shall forthwith inform the Commission thereof. 2. By way of exception from paragraph 1: - the Hellenic Republic, the Kingdom of Spain and the Portuguese Republic have until 31 December 1995 to comply with Article 1 and 2, - Ireland shall have until 31 December 1998 to comply with Article 1 as regards pillion passengers of motorcycles and until 31 December 1995 to comply with Article 1 as regards other vehicles and to comply with Article 2. Article 7 This Directive is addressed to the Member States.

31990L0270

1990

COUNCIL DIRECTIVE of 29 May 1990 on the minimum safety and health requirements for work with display screen equipment (fifth individual Directive within the meaning of Article 16 (1) of Directive 87/391/EEC) (90/270/EEC) Having regard to the Treaty establishing the European Economic Community, and in particular Article 118a thereof, Having regard to the Commission proposal (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 Article 118a of the Treaty provides that the Council shall adopt, by means of Directives, minimum requirements designed to encourage improvements, especially in the working environment, to ensure a better level of protection of workers' safety and health; Whereas, under the terms of that Article, those Directives shall 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 measures in respect of new technologies; whereas the Council has taken note thereof in its resolution of 21 December 1987 on safety, hygiene and health at work (5); Whereas compliance with the minimum requirements for ensuring a better level of safety at workstations with display screens is essential for ensuring the safety and health of workers; 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 (6); whereas the provisions of the latter are therefore fully applicable to the use by workers of display screen equipment, without prejudice to more stringent and/or specific provisions contained in the present Directive; Whereas employers are obliged to keep themselves informed of the latest advances in technology and scientific findings concerning workstation design so that they can make any changes necessary so as to be able to guarantee a better level of protection of workers' safety and health; Whereas the ergonomic aspects are of particular importance for a workstation with display screen equipment; Whereas this Directive is a practical contribution towards creating the social dimension of the internal market; Whereas, pursuant to Decision 74/325/EEC (7), the Advisory Committee on Safety, Hygiene and Health Protection at Work shall be consulted by the Commission on the drawing-up of proposals in this field, SECTION I GENERAL PROVISIONS Article 1 Subject 1. This Directive, which is the fifth individual Directive within the meaning of Article 16 (1) of Directive 89/391 /EEC, lays down minimum safety and health requirements for work with display screen equipment as defined in Article 2. 2. The provisions of Directive 89/391/EEC are fully applicable to the whole field referred to in paragraph 1, without prejudice to more stringent and/or specific provisions contained in the present Directive. 3. This Directive shall not apply to: (a) drivers' cabs or control cabs for vehicles or machinery; (b) computer systems on board a means of transport; (c) computer systems mainly intended for public use; (d) ‘portable’ systems not in prolonged use at a workstation; (e) calculators, cash registers and any equipment having a small data or measurement display required for direct use of the equipment; (f) typewriters of traditional design, of the type known as ‘typewriter with window’. Article 2 Definitions For the purpose of this Directive, the following terms shall have the following meanings: (a) display screen equipment: an alphanumeric or graphic display screen, regardless of the display process employed; (b) workstation: an assembly comprising display screen equipment, which may be provided with a keyboard or input device and /or software determining the operator/machine interface, optional accessories, peripherals including the diskette drive, telephone, modem, printer, document holder, work chair and work desk or work surface, and the immediate work environment; (c) worker: any worker as defined in Article 3 (a) of Directive 89/391/EEC who habitually uses display screen equipment as a significant part of his normal work. SECTION II EMPLOYERS' OBLIGATIONS Article 3 Analysis of workstations 1. Employers shall be obliged to perform an analysis of workstations in order to evaluate the safety and health conditions to which they give rise for their workers, particularly as regards possible risks to eyesight, physical problems and problems of mental stress. 2. Emyployers shall take appropriate measures to remedy the risks found, on the basis of the evaluation referred to in paragraph 1, taking account of the additional and/or combined effects of the risks so found. Article 4 Workstations put into service for the first time Employers must take the appropriate steps to ensure that workstations first put into service after 31 December 1992 meet the minimum requirements laid down in the Annex. Article 5 Workstations already put into service Employers must take the appropriate steps to ensure that workstations already put into service on or before 31 December 1992 are adapted to comply with the minimum requirements laid down in the Annex not later than four years after that date. Article 6 Information for, and training of, workers 1. Without prejudice to Article 10 of Directive 89/391/EEC, workers shall receive information on all aspects of safety and health relating to their workstation, in particular information on such measures applicable to workstations as are implemented under Articles 3, 7 and 9. In all cases, workers or their representatives shall be informed of any health and safety measure taken in compliance with this Directive. 2. Without prejudice to Article 12 of Directive 89/391/EEC, every worker shall also receive training in use of the workstation before commencing this type of work and whenever the organization of the workstation is substantially modified. Article 7 Daily work routine The employer must plan the worker's activities in such a way that daily work on a display screen is periodically interrupted by breaks or changes of activity reducing the workload at the display screen. Article 8 Worker consultation and 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 its Annex. Article 9 Protection of workers' eyes and eyesight 1. Workers shall be entitled to an appropriate eye and eyesight test carried out by a person with the necessary capabilities: — before commencing display screen work, — at regular intervals thereafter, and — if they experience visual difficulties which may be due to display screen work. 2. Workers shall be entitled to an ophthalmological examination if the results of the test referred to in paragraph 1 show that this is necessary. 3. If the results of the test referred to in paragraph 1 or of the examination referred to in paragraph 2 show that it is necessary and if normal corrective appliances cannot be used, workers must be provided with special corrective appliances appropriate for the work concerned. 4. Measures taken pursuant to this Article may in no circumstances involve workes in additional financial cost. 5. Protection of workers' eyes and eyesight may be provided as part of a national health system. SECTION III MISCELLANEOUS PROVISIONS Article 10 Adaptations to the Annex The strictly technical adaptations to the Annex to take account of technical progress, developments in international regulations and specifications and knowledge in the field of display screen equipment shall be adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC. Article 11 Final provisions 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 forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt, or have already adopted, in the field covered by this Directive. 3. 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. 4. The Commission shall submit a report on the implementation of this Directive at regular intervals to the European Parliament, the Council and the Economic and Social Committee, taking into account paragraphs 1, 2 and 3. Article 12 This Directive is addressed to the Member States.

31990L0269

1990

COUNCIL DIRECTIVE of 29 May 1990 on the minimum health and safety requirements for the manual handling of loads where there is a risk particularly of back injury to workers (fourth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) (90/269/EEC) Having regard to the Treaty establishing the European Economic Community, and in particular Article 118a thereof Having regard to the Commission proposal (1) submitted 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 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 health and safety 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 Commission communication on its programme concerning safety, hygiene and health at work (4), provides for the adoption of Directives designed to guarantee the health and safety of workers at the workplace; Whereas the Council, in its resolution of 21 December 1987 on safety, hygiene and health at work (5), took note of the Commission's intention of submitting to the Council in the near future a Directive on protection against the risks resulting from the manual handling of heavy loads; Whereas compliance with the minimum requirements designed to guarantee a better standard of health and safety at the workplace is essential to ensure the health and safety of workers; 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 health and safety of workers at work (6); whereas therefore the provisions of the said Directive are fully applicable to the field of the manual handling of loads where there is a risk particularly of back injury to workers, without prejudice to more stringent and/or specific provisions set out in this Directive; Whereas this Directive constitutes a practical step towards the achievement of the social dimension of the internal market; Whereas, pursuant to Decision 74/325/EEC (7), the Advisory Committee on Safety, Hygiene and Health Protection at Work shall be consulted by the Commission with a view to drawing up proposals in this field, SECTION I GENERAL PROVISIONS Article 1 Subject 1. This Directive, which is the fourth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC, lays down minimum health and safety requirements for the manual handling of loads where there is a risk particularly of back injury to workers. 2. The provisions of Directive 89/391 /EEC shall be fully applicable to the whole sphere referred to in paragraph 1, without prejudice to more restrictive and/or specific provisions contained in this Directive. Article 2 Definition For the purposes of this Directives, ‘manual handling of loads’ means any transporting or supporting of a load, by one or more workers, including lifting, putting down, pushing, pulling, carrying or moving of a load, which, by reason of its characteristics or of unfavourable ergonomic conditions, involves a risk particularly of back injury to workers. SECTION II EMPLOYERS' OBLIGATIONS Article 3 General provision 1. The employer shall take appropriate organizational measures, or shall use the appropriate means, in particular mechanical equipment, in order to avoid the need for the manual handling of loads by workers. 2. Where the need for the manual handling of loads by workers cannot be avoided, the employer shall take the appropriate organizational measures, use the appropriate means or provide workers with such means in order to reduce the risk involved in the manual handling of such loads, having regard to Annex I. Article 4 Organization of workstations Wherever the need for manual handling of loads by workers cannot be avoided, the employer shall organize workstations in such a way as to make such handling as safe and healthy as possible and: (a) assess, in advance if possible, the health and safety conditions of the type of work involved, and in particular examine the characteristics of loads, taking account of Annex I; (b) take care to avoid or reduce the risk particularly of back injury to workers, by taking appropriate measures, considering in particular the characteristics of the working environment and the requirements of the activity, taking account of Annex I. Article 5 Reference to Annex II For the implementation of Article 6 (3) (b) and Articles 14 and 15 of Directive 89/391/EEC, account should be taken of Annex II. Article 6 Information for, and training of, workers 1. Without prejudice to Article 10 of Directive 89/391/EEC, workers and/or their representatives shall be informed of all measures to be implemented, pursuant to this Directive, with regard to the protection of safety and of health. Employers must ensure that workers and/or their representatives receive general indications and, where possible, precise information on: — the weight of a load, — the centre of gravity of the heaviest side when a package is eccentrically loaded. 2. Without prejudice to Article 12 of Directive 83/391/EEC, employers must ensure that workers receive in addition proper training and information on how to handle loads correctly and the risks they might be open to particularly if these tasks are not performed correctly, having regard to Annexes I and II. Article 7 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 matters covered by this Directive, including the Annexes thereto. SECTION III MISCELLANEOUS PROVISIONS Article 8 Adjustment of the Annexes Alterations of a strictly technical nature to Annexes I and II resulting from technical progress and changes in international regulations and specifications or knowledge in the field of the manual handling of loads shall be adopted in accordance with the procedure provided for in Article 17 of Directive 89/391/EEC. Article 9 Final provisions 1. Member States shall bring into force the laws, regulations and administrative provisions needed to comply with this Directive not later than 31 December 1992. They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt, or have adopted, in the field covered by this Directive. 3. 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 thereof. 4. The Commission shall report periodically to the European Parliament, the Council and the Economic and Social Committee on the implementation of the Directive in the light of paragraphs 1, 2 and 3. Article 10 This Directive is addressed to the Member States.

31990L0335

1990

Commission Directive 90/335/EEC of 7 June 1990 amending for the fourth time the Annex to Council Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances (1), as last amended by Directive 89/365/EEC (2), and in particular Article 6 thereof, Whereas the development of scientific and technical knowledge makes necessary certain amendments to the Annex to Directive 79/117/EEC; Whereas it seems desirable to delete a certain number of temporary derogations from the prohibitions laid down in the Directive since less hazardous treatments are now available; Whereas all Member States have informed the Commission that they do not intend or no longer intend to avail themselves of these derogations; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 The Annex to Directive 79/117/EEC is hereby amended as follows: 1. In Part A, 'Mercury compounds': (a) Under item 4, 'Alkyl mercury compounds', the text in column 2 is deleted; (b) under item 5, 'Alkoxyalkyl and aryl mercury compounds', the text in column 2 is replaced by: 'Seed treatment cereals'. 2. In part B, 'Persistent organo-chlorine compounds': (a) under item 1, 'Aldrin', the text in column 2 is deleted; (b) under item 5, 'Endrin', the text in column 2 is deleted. Article 2 Member States shall, not later than 1 January 1991, bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately inform the Commission thereof. Article 3 This Directive is addressed to the Member States.

31990L0314

1990

COUNCIL DIRECTIVE of 13 June 1990 on package travel, package holidays and package tours (90/314/EEC) 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 one of the main objectives of the Community is to complete the internal market, of which the tourist sector is an essential part; Whereas the national laws of Member States concerning package travel, package holidays and package tours, hereinafter referred to as ‘packages’, show many disparities and national practices in this field are markedly different, which gives rise to obstacles to the freedom to provide services in respect of packages and distortions of competition amongst operators established in different Member States; Whereas the establishment of common rules on packages will contribute to the elimination of these obstacles and thereby to the achievement of a common market in services, thus enabling operators established in one Member State to offer their services in other Member States and Community consumers to benefit from comparable conditions when buying a package in any Member State; Whereas paragraph 36 (b) of the Annex to the Council resolution of 19 May 1981 on a second programme of the European Economic Community for a consumer protection and information policy (4) invites the Commission to study, inter alia, tourism and, if appropriate, to put forward suitable proposals, with due regard for their significance for consumer protection and the effects of differences in Member States' legislation on the proper functioning of the common market; Whereas in the resolution on a Community policy on tourism on 10 April 1984 (5) the Council welcomed the Commission's initiative in drawing attention to the importance of tourism and took note of the Commission's initial guidelines for a Community policy on tourism; Whereas the Commission communication to the Council entitled ‘A New Impetus for Consumer Protection Policy’, which was approved by resolution of the Council on 6 May 1986 (6), lists in paragraph 37, among the measures proposed by the Commission, the harmonization of legislation on packages; Whereas tourism plays an increasingly important role in the economies of the Member States; whereas the package system is a fundamental part of tourism; whereas the package travel industry in Member States would be stimulated to greater growth and productivity if at least a minimum of common rules were adopted in order to give it a Community dimension; whereas this would not only produce benefits for Community citizens buying packages organized on the basis of those rules, but would attract tourists from outside the Community seeking the advantages of guaranteed standards in packages; Whereas disparities in the rules protecting consumers in different Member States are a disincentive to consumers in one Member State from buying packages in another Member State; Whereas this disincentive is particularly effective in deterring consumers from buying packages outside their own Member State, and more effective than it would be in relation to the acquisition of other services, having regard to the special nature of the services supplied in a package which generally involve the expenditure of substantial amounts of money in advance and the supply of the services in a State other than that in which the consumer is resident; Whereas the consumer should have the benefit of the protection introduced by this Directive irrespective of whether he is a direct contracting party, a transferee or a member of a group on whose behalf another person has concluded a contract in respect of a package; Whereas the organizer of the package and/or the retailer of it should be under obligation to ensure that in descriptive matter relating to packages which they respectively organize and sell, the information which is given is not misleading and brochures made available to consumers contain information which is comprehensible and accurate; Whereas the consumer needs to have a record of the terms of contract applicable to the package; whereas this can conveniently be achieved by requiring that all the terms of the contract be stated in writing of such other documentary form as shall be comprehensible and accessible to Mm, and that he be given a copy thereof; Whereas the consumer should be at liberty in certain circumstances to transfer to a willing third person a booking made by him for a package; Whereas the price established under the contract should not in principle be subject to revision except where the possibility of upward or downward revision is expressly provided for in the contract; whereas that possibility should nonetheless be subject to certain conditions; Whereas the consumer should in certain circumstances be free to withdraw before departure from a package travel contract; Whereas there should be a clear definition of the rights available to the the consumer in circumstances where the organizer of the package cancels it before the agreed date of departure; Whereas if, after the consumer has departed, there occurs a significant failure of performance of the services for which he has contracted or the organizer perceives that he will be unable to procure a significant part of the services to be provided; the organizer should have certain obligations towards the consumer; Whereas the organizer and/or retailer party to the contract should be liable to the consumer for the proper performance of the obligations arising from the contract; whereas, moreover, the organizer and/or retailer should be liable for the damage resulting for the consumer from failure to perform or improper performance of the contract unless the defects in the performance of the contract are attributable neither to any fault of theirs nor to that of another supplier of services; Whereas in cases where the organizer and/or retailer is liable for failure to perform or improper performance of the services involved in the package, such liability should be limited in accordance with the international conventions governing such services, in particular the Warsaw Convention of 1929 in International Carriage by Air, the Berne Convention of 1961 on Carriage by Rail, the Athens Convention of 1974 on Carriage by Sea and the Paris Convention of 1962 on the Liability of Hotel-keepers; whereas, moreover, with regard to damage other than personal injury, it should be possible for liability also to be limited under the package contract provided, however, that such limits are not unreasonable; Whereas certain arrangements should be made for the information of consumers and the handling of complaints; Whereas both the consumer and the package travel industry would benefit if organizers and/or retailers were placed under an obligation to provide sufficient evidence of security in the event of insolvency; Whereas Member States should be at liberty to adopt, or retain, more stringent provisions relating to package travel for the purpose of protecting the consumer, Article 1 The purpose of this Directive is to approximate the laws, regulations and administrative provisions of the Member States relating to packages sold or offered for sale in the territory of the Community. Article 2 For the purposes of this Directive: 1. ‘package’ means the pre-arranged combination of not fewer than two of the following when sold or offered for sale at an inclusive price and when the service covers a period of more than twenty-four hours or includes overnight accommodation: (a) transport; (b) accommodation; (c) other tourist services not ancillary to transport or accommodation and accounting for a significant proportion of the package. The separate billing of various components of the same package shall not absolve the organizer or retailer from the obligations under this Directive; 2. ‘organizer’ means the person who, other than occasionally, organizes packages and sells or offers them for sale, whether directly or through a retailer; 3. ‘retailer’ means the person who sells or offers for sale the package put together by the organizer; 4. ‘consumer’ means the person who takes or agrees to take the package (‘the principal contractor’), or any person on whose behalf the principal contractor agrees to purchase the package (‘the other beneficiaries’) or any person to whom the principal contractor or any of the other beneficiaries transfers the package (‘the transferee’); 5. ‘contract’ means the agreement linking the consumer to the organizer and/or the retailer. Article 3 1. Any descriptive matter concerning a package and supplied by the organizer or the retailer to the consumer, the price of the package and any other conditions applying to the contract must not contain any misleading information. 2. When a brochure is made available to the consumer, it shall indicate in a legible, comprehensible and accurate manner both the price and adequate information concerning: (a) the destination and the means, characteristics and categories of transport used; (b) the type of accommodation, its location, category or degree of comfort and its main features, its approval and tourist classification under the rules of the host Member State concerned; (c) the meal plan; (d) the itinerary; (e) general information on passport and visa requirements for nationals of the Member State or States concerned and health formalities required for the journey and the stay; (f) either the monetary amount or the percentage of the price which is to be paid on account, and the timetable for payment of the balance; (g) whether a minimum number of persons is required for the package to take place and, if so, the deadline for informing the consumer in the event of cancellation. The particulars contained in the brochure are binding on the organizer or retailer, unless: — changes in such particulars have been clearly communicated to the consumer before conclusion of the contract, in which case the brochure shall expressly state so, — changes are made later following an agreement between the parties to the contract. Article 4 1. (a) The organizer and/or the retailer shall provide the consumer, in writing or any other appropriate form, before the contract is concluded, with general information on passport and visa requirements applicable to nationals of the Member State or States concerned and in particular on the periods for obtaining them, as well as with information on the health formalities required for the journey and the stay; (b) The organizer and/or retailer shall also provide the consumer, in writing or any other appropriate form, with the following information in good time before the start of the journey: (i) the times and places of intermediate stops and transport connections as well as details of the place to be occupied by the traveller, e.g. cabin or berth on ship, sleeper compartment on train; (ii) the name, address and telephone number of the organizer's and/or retailer's local representative or, failing that, of local agencies on whose assistance a consumer in difficulty could call. Where no such representatives or agencies exist, the consumer must in any case be provided with an emergency telephone number or any other information that will enable him to contract the organizer and/or the retailer; (iii) in the case of journeys or stays abroad by minors, information enabling direct contact to be established with the child or the person responsible at the child's place of stay; (iv) information on the optional conclusion of an insurance policy to cover the cost of cancellation by the consumer or the cost of assistance, including repatriation, in the event of accident or illness. 2. Member States shall ensure that in relation to the contract the following principles apply: (a) depending on the particular package, the contract shall contain at least the elements listed in the Annex; (b) all the terms of the contract are set out in writing or such other form as is comprehensible and accessible to the consumer and must be communicated to him before the conclusion of the contract; the consumer is given a copy of these terms; (c) the provision under (b) shall not preclude the belated conclusion of last-minute reservations or contracts. 3. Where the consumer is prevented from proceeding with the package, he may transfer his booking, having first given the organizer or the retailer reasonable notice of his intention before departure, to a person who satisfies all the conditions applicable to the package. The transferor of the package and the transferee shall be jointly and severally liable to the organizer or retailer party to the contract for payment of the balance due and for any additional costs arising from such transfer. 4. (a) The prices laid down in the contract shall not be subject to revision unless the contract expressly provides for the possibility of upward or downward revision and states precisely how the revised price is to be calculated, and solely to allow for variations in: — transportation costs, including the cost of fuel, — dues, taxes or fees chargeable for certain services, such as landing taxes or embarkation or disembarkation fees at ports and airports, — the exchange rates applied to the particular package. (b) During the twenty days prior to the departure date stipulated, the price stated in the contract shall not be increased. 5. If the organizer finds that before the departure he is constrained to alter significantly any of the essential terms, such as the price, he shall notify the consumer as quickly as possible in order to enable him to take appropriate decisions and in particular: — either to withdraw from the contract without penalty, — or to accept a rider to the contract specifying the alterations made and their impact on the price. The consumer shall inform the organizer or the retailer of his decision as soon as possible. 6. If the consumer withdraws from the contract pursuant to paragraph 5, or if, for whatever cause, other than the fault of the consumer, the organizer cancels the package before the agreed date of departure, the consumer shall be entitled: (a) either to take a substitute package of equivalent or higher quality where the organizer and/or retailer is able to offer him such a substitute. If the replacement package offered is of lower quality, the organizer shall refund the difference in price to the consumer; (b) or to be repaid as soon as possible all sums paid by him under the contract. In such a case, he shall be entitled, if appropriate, to be compensated by either the organizer or the retailer, whichever the relevant Member State's law requires, for non-performance of the contract, except where: (i) cancellation is on the grounds that the number of persons enrolled for the package is less than the minimum number required and the consumer is informed of the cancellation, in writing, within the period indicated in the package description; or (ii) cancellation, excluding overbooking, is for reasons of force majeure, i.e. unusual and unforeseeable circumstances beyond the control of the party by whom it is pleaded, the consequences of which could not have been avoided even if all due care had been exercised. 7. Where, after departure, a significant proportion of the services contracted for is not provided or the organizer perceives that he will be unable to procure a significant proportion of the services to be provided, the organizer shall make suitable alternative arrangements, at no extra cost to the consumer, for the continuation of the packag, and where appropriate compensate the consumer for the difference between the services offered and those supplied. If it is impossible to make such arrangements or these are not accepted by the consumer for good reasons, the organizer shall, where appropriate, provide the consumer, at no extra cost, with equivalent transport back to the place of departure, or to another return-point to which the consumer has agreed and shall, where appropriate, compensate the consumer. Article 5 1. Member States shall take the necessary steps to ensure that the organizer and/or retailer party to the contract is liable to the consumer for the proper performance of the obligations arising from the contract, irrespective of whether such obligations are to be performed by that organizer and/or retailer or by other suppliers of services without prejudice to the right of the organizer and/or retailer to pursue those other suppliers of services. 2. With regard to the damage resulting for the consumer from the failure to perform or the improper performance of the contract, Member States shall take the necessary steps to ensure that the organizer and/or retailer is/are liable unless such failure to perform or improper performance is attributable neither to any fault of theirs nor to that of another supplier of services, because: — the failures which occur in the performance of the contract are attributable to the consumer, — such failures are attributable to a third party unconnected with the provision of the services contracted for, and are unforeseeable or unavoidable, — such failures are due to a case of force majeure such as that defined in Article 4 (6), second subparagraph (ii), or to an event which the organizer and/or retailer or the supplier of services, even with all due care, could not foresee or forestall. In the cases referred to in the second and third indents, the organizer and/or retailer party to the contract shall be required to give prompt assistance to a consumer in difficulty. In the matter of damages arising from the non-performance or improper performance of the services involved in the package, the Member States may allow compensation to be limited in accordance with the international conventions governing such services. In the matter of damage other than personal injury resulting from the non-performance or improper performance of the services involved in the package, the Member States may allow compensation to be limited under the contract. Such limitation shall not be unreasonable. 3. Without prejudice to the fourth subparagraph of paragraph 2, there may be no exclusion by means of a contractual clause from the provisions of paragraphs 1 and 2. 4. The consumer must communicate any failure in the performance of a contract which he perceives on the spot to the supplier of the services concerned and to the organizer and/or retailer in writing or any other appropriate form at the earliest opportunity. This obligation must be stated clearly and explicily in the contract. Article 6 In cases of complaint, the organizer and/or retailer or his local representative, if there is one, must make prompt efforts to find appropriate solutions. Article 7 The organizer and/or retailer party to the contract shall provide sufficient evidence of security for the refund of money paid over and for the repatriation of the consumer in the event of insolvency. Article 8 Member States may adopt or return more stringent provisions in the field covered by this Directive to protect the consumer. Article 9 1. Member States shall bring into force the measures necessary to comply with this Directive before 31 December 1992. They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 10 This Directive is addressed to the Member States.

31990L0384

1990

Council Directive 90/384/EEC of 20 June 1990 on the harmonization of the laws of the Member States relating to non-automatic weighing instruments 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 Member States have the responsibility of protecting the public against incorrect results of weighing operations by means of non-automatic weighing instruments when used for certain categories of applications; Whereas, in each Member State, mandatory provisions fix in particular the necessary performance requirements of non-automatic weighing instruments by specifying metrological and technical requirements, together with inspection procedures before and after going into service; whereas these mandatory provisions do not necessarily lead to different levels of protection from one Member State to another but do, by their disparity, impede trade within the Community; Whereas the national provisions ensuring such protection must be harmonized in order to guarantee the free movement of non-automatic weighing instruments while ensuring a justified level of protection in the Community; OJ No C 297, 25. 11. 1989, p. 13. OJ No C 149, 18. 6. 1990. Whereas Community legislation as it stands at present provides that, notwithstanding one of the fundamental rules of the Community, namely the free movement of goods, barriers to intra-Community movement resulting from disparities in national laws on the use of products have to be accepted in so far as the provisions of those national laws are recognized as necessary to ensure that the products concerned meet essential requirements; whereas the harmonization of laws in the present case must therefore be confined to those provisions needed to ensure that non-automatic weighing instruments satisfy the essential metrological and performance requirements; whereas, because they are essential, these requirements must replace the corresponding national provisions; Whereas this Directive therefore contains only mandatory and essential requirements; whereas, to facilitate proof of conformity with the essential requirements, it is necessary to have harmonized standards at European level, in particular as to the metrological, design and construction characteristics, so that instruments complying with those harmonized standards may be assumed to conform to the essential requirements; whereas these standards, harmonized at European level, are drawn up by private bodies and must remain non-mandatory texts; whereas for that purpose 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 for cooperation between the Commission and those two bodies signed on 13 November 1984; whereas, within the meaning of this Directive, a harmonized standard is a technical specification (European standard or harmonized document) adopted by one or both of those bodies upon a remit from 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), as amended by Directive 88/182/EEC (5), and the abovementioned general guidelines; Whereas assessment of conformity with the relevant metrological and technical provisions is necessary to provide effective protection for users and third parties; whereas, the existing conformity assessment procedures differ from one Member State to another; whereas, to avoid multiple assessments of conformity, which are in effect barriers to the free movement of the instruments, arrangements should be made for the mutual recognition of conformity assessment procedures by the Member States; whereas, to facilitate the mutual recognition of conformity assessment procedures, harmonized Community procedures should be set up, together with harmonized criteria for the designation of the bodies responsible for carrying out tasks pertaining to the conformity assessment procedures; Whereas it is therefore essential to ensure that such designated bodies ensure a high level of quality throughout the Community; Whereas the presence on a non-automatic weighing instrument of the EC mark of conformity or of the sticker bearing the letter 'M' indicates that there is a presumption that it satisfies the provisions of this Directive and therefore makes it unnecessary to repeat the assessments of conformity already carried out; Whereas the measures aimed at the gradual establishment of the internal market must be adopted by 31 December 1992; whereas the internal market consists of an area without internal frontiers within which the free movement of goods, persons, services and capital is guaranteed, CHAPTER I Scope, placing on the market, free movement Article 1 1. A weighing instrument is defined as a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities, parameters or characteristics. A non-automatic weighing instrument is defined as a weighing instrument requiring the intervention of an operator during weighing. This Directive applies to all non-automatic weighing instruments, hereinafter referred to as 'instruments'. 2. A distinction is made in this Directive between two categories of instrument use: (a) 1. determination of mass for commercial transactions; 2. determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment; 3. determination of mass for the application of laws or regulations; expert opinion given in court proceedings; 4. determination of mass in the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment; 5. determination of mass for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories; 6. determination of price on the basis of mass for the purposes of direct sales to the public and the making-up of prepackages; (b) all applications other than those listed in point 2 (a) of this Article. Article 2 1. Member States shall take all steps to ensure that instruments may not be placed on the market unless they meet the requirements of this Directive which apply to them. 2. Member States shall take all steps to ensure that instruments may not be put into service for the uses referred to in Article 1 (2) (a) unless they meet the requirements of this Directive which apply to them. Article 3 Instruments used for the applications listed in Article 1 (2) (a) must satisfy the essential requirements set out in Annex I. In cases where the instrument includes or is connected to devices which are not used for the applications listed in Article 1 (2) (a), such devices shall not be subject to the essential requirements. Article 4 1. Member States shall not impede the placing on the market of instruments which meet the requirements of this Directive which apply to them. 2. Member States shall not impede the putting into service for the uses referred to in Article 1 (2) (a) of instruments which meet the requirements of this Directive which apply to them. Article 5 1. Member States shall presume conformity with the essential requirements referred to in Article 3 in respect of instruments which comply with the relevant national standards implementing the harmonized standards that meet the essential requirements referred to in Article 3. 2. The Commission shall publish the references of the harmonized standards referred to in paragraph 1 in the Official Journal of the European Communities. Member States shall publish the references of the national standards referred to in paragraph 1. Article 6 Where a Member State or the Commission considers that the harmonized standards referred to in Article 5 (1) do not fully meet 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 under Directive 83/189/EEC, hereinafter referred to as 'the Committee', giving its reasons for doing so. The Committee shall deliver an opinion without delay. In the light of the Committee's opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw those standards from the publications referred to in Article 5 (2). Article 7 1. Where a Member State considers that instruments bearing the EC mark of conformity referred to in Annex 2, sections 2, 3 and 4, do not meet the requirements of this Directive when properly installed and used for the purposes for which they are intended, it shall take all appropriate measures to withdraw those instruments from the market or to prohibit or restrict their being put into service and/or placed on the market. The Member State concerned shall immediately inform the Commission of any such measure, indicating the reasons for its decision, and in particular whether non-compliance is due to: (a) failure to meet the essential requirements referred to in Article 3, where instruments do not meet the standards referred to in Article 5 (1); (b) incorrect application of the standards referred to in Article 5 (1); (c) shortcomings in the standards referred to in Article 5 (1) themselves. 2. The Commission shall enter into consultation with the parties concerned as soon as possible. After such consultation the Commission shall immediately inform the Member State, which took the action, of the result. Should it find that the measure is justified it shall immediately inform the other Member States. If the decision is attributed to shortcomings in the standards, the Commission, after consulting the parties concerned, shall bring the matter before the Committee within two months if the Member State which has taken the measures intends to maintain them, and shall subsequently initiate the procedures referred to in Article 6. 3. Where an instrument which does not comply bears the EC mark of conformity, 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. CHAPTER II Conformity assessment Article 8 1. The conformity of instruments to the essential requirements set out in Annex I may be certified by either of the following procedures as selected by the applicant: (a) EC type examination as referred to in Annex II.1, followed either by the EC declaration of type conformity (guarantee of production quality) as referred to in Annex II.2, or by the EC verification as referred to in Annex II.3. However, EC type examination shall not be compulsory for instruments which do not use electronic devices and whose load-measuring device does not use a spring to balance the load; (b) EC unit verification as referred to in Annex II.4. 2. The documents and correspondence relating to the procedures referred to in paragraph 1 shall be drafted in an official language of the Member State where the said procedures are to be carried out, or in a language accepted by the competent body. 3. Where the instruments are subject to other Community Directives concerning other aspects, the EC mark referred to in Article 10 shall indicate in these cases that the instruments also fulfil the requirements of the other Directives. Article 9 1. Member States shall notify to the other Member States and the Commission the bodies which they have designated for carrying out tasks pertaining to the procedure referred to in Article 8, the specific tasks for which each body has been designated, and the identification codes of the designated bodies. The Commission shall publish the list of these notified bodies, together with the tasks for which they have been designated, in the Official Journal of the European Communities and shall ensure that the list is kept up to date. 2. Member States shall apply the minimum criteria set out in Annex V for the designation of bodies. Bodies which satisfy the criteria fixed by the relevant harmonized standards shall be presumed to satisfy the criteria set out in Annex V. 3. A Member State which has designated a body shall cancel the designation if the body no longer meets the criteria for designation referred to in paragraph 2. It shall immediately inform the other Member States and the Commission thereof and withdraw the notification. CHAPTER III EC mark of conformity and inscriptions Article 10 1. The EC mark of conformity and the required supplementary data as described in Annex IV.1 shall be affixed in a clearly visible, easily legible and indelible form to instruments for which EC conformity has been established. 2. The inscriptions referred to in Annex IV.2 shall be affixed in a clearly visible, easily legible and indelible form to all other instruments. 3. The affixing to instruments of marks which are likely to be confused with the EC mark of conformity shall be prohibited. Article 11 Where it is established that the EC mark of conformity has been wrongly affixed to instruments: - not conforming to the standards referred to in Article 5 (1), where the manufacturer has chosen to manufacture instruments that conform to those standards, - not conforming to an approved type, - conforming to an approved type which does not meet the essential requirements applicable to it, - in respect of which the manufacturer has failed to fulfil his obligations under the EC declaration of type conformity (guarantee of production quality), the competent notified body shall, where necessary, withdraw the EC type-approval and/or the approval of the quality system. Withdrawal of EC type-approval shall have the effect of prohibiting submission for EC verification and the EC declaration of type conformity (guarantee of production quality). Article 12 Where an instrument which is used for any of the applications referred to in Article 1 (2) (a) includes or is connected to devices that have not been subject to conformity assessment as referred to in Article 8, each of these devices shall bear the symbol restricting its use as defined by Annex IV.3. This symbol shall be affixed to the devices in a clearly visible and indelible form. CHAPTER IV Final provisions Article 13 Member States shall take all steps to ensure that instruments bearing the EC mark attesting conformity with the requirements of this Directive continue to conform to those requirements. Article 14 Any decision taken pursuant to this Directive and resulting in restrictions on the putting into service of an instrument shall state the exact grounds on which it is based. Such a decision shall be notified without delay to the party concerned, who shall at the same time be informed of the judicial remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject. Article 15 1. Member States shall, before 1 July 1992, adopt and publish the laws, regulations and administrative provisions necessary in order to comply with this Directive. They shall forthwith inform the Commission thereof. 2. Member States shall apply such provisions from 1 January 1993. 3. However, by way of derogation from paragraph 2, Member States shall permit during a period of 10 years from the date on which they apply the provisions referred to in paragraph 1 the placing on the market and/or putting into service of instruments which conform to the rules in force before that date. 4. 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. 5. Directive 73/360/EEC shall be repealed as from 1 January 1993, except as regards the application of paragraph 3. Article 16 This Directive is addressed to the Member States.

31990L0427

1990

COUNCIL DIRECTIVE of 26 June 1990 on the zootechnical and genealogical conditions governing intra-Community trade in equidae (90/427/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 equidae, being live animals, are included in the list of products in Annex II to the Treaty; Whereas in order to ensure the rational development of equidae production, thereby increasing productivity in that sector, rules governing the marketing of equidae in intra-Community trade must be laid down at Community level; Whereas the breeding and rearing of equidae and in particular of horses is generally included in the farming sector; whereas it constitutes a source of income for part of the farming population and should therefore be encouraged; Whereas satisfactory results in that respect depend largely on the use of equidae registered in stud books maintained by officially approved organizations or associations; Whereas disparities exist as regards entry in studbooks; whereas those disparities constitute a barrier to trade within the Community; whereas complete liberalization of trade calls for further harmonization, particularly regarding entry in studbooks; Whereas intra-Community trade in registered equidae should be progressively liberalized; whereas complete liberalization of trade requires further additional harmonization, in particular as regards approval for the purpose of off-farm mating and the use of semen and ova in accordance with the characteristics of each studbook; Whereas it is necessary to draw up, in accordance with a Community procedure, a harmonized model zootechnical origin and identification certificate; Whereas the name of an animal is an essential factor in identifying equidae; whereas it is often impossible to trace an animal's descent and monitor its progress if its name is changed at a new owner's request; whereas the rules regarding the naming of equidae should be harmonized, in particular in order to prevent unfair practices; Whereas provisions should be introduced preventing equidae from third countries from being imported on terms which are less stringent than those applicable within the Community; Whereas it is advisable to adopt implementing measures regarding certain technical aspects; whereas, for the purposes of the measures envisaged, provision should be made for close and effective cooperation between Member States and the Commission within the Standing Committee on Zootechnics, CHAPTER I General provisions Article 1 This Directive lays down the zootechnical and genealogical conditions governing intra-Community trade in equidae, their semen, ova and embryos. Article 2 For the purposes of this Directive: (a) ‘quidae’ means domestic animals of the equine or asinine species or crossbreeds thereof; (b) ‘registered equidae’ means equidae which are entered or registered and eligible for entry in a studbook, in accordance with the rules laid down pursuant to Article 4 (2) (b) and identified by means of the identification document provided for in Article 8 (1); (c) ‘studbook’ means any book, register, file or data medium: — which is maintained either by an organization or an association officially approved or recognized by a Member State or by an official agency of the Member State concerned, and — in which equidae are entered or registered with mention of all their known ascendants. Article 3 Intra-Community trade in equidae and their semen, ova and embryos may not be prohibited or restricted on zootechnical or genealogical grounds other than those resulting from application of this Directive. However, in the case of intra-Community trade in registered equidae, their semen, ova and embryos, national provisions which comply with the general rules of the Treaty shall be maintained pending the entry into force of the relevant Community decisions referred to in Articles 4 and 8. CHAPTER II Genealogical rules relating to registered equidae Article 4 1. The following principles shall be taken into account when the decisions referred to in paragraph 2 are adopted: (a) the recognition or approval of organizations and associations which maintain or establish studbooks shall be subject to compliance with the principles laid down by the organization or association which maintains the studbook of the origin of the breed; (b) the criteria for entry and registration in studbooks shall be laid down on the basis of the characteristics of the breed and in particular for certain pure breeds of the need to regulate the entry and registration of equidae produced using artificial reproduction methods. 2. The Commission shall establish under the procedure laid down in Article 10 and in accordance with the principles set out in paragraph 1: (a) the criteria for the approval or recognition of organizations and associations which maintain or establish studbooks; (b) the criteria for entry and registration in studbooks; (c) if necessary, the criteria and methods used to identify registered equidae; (d) the criteria for drawing up the certificate of origin and the identification document referred to in Article 8; (e) if necessary, rules to ensure coordination between the organizations or associations referred to in Article 5. Article 5 The list of organizations and associations maintaining or establishing studbooks, which are recognized on the basis of the criteria to be determined in accordance with Article 4 (2) (a) and subsequent updatings, shall be communicated to the Commission and the other Member States within the Standing Committee on Zootechnics. Article 6 1. In intra-Community trade, equidae, which are registered in the Member State of dispatch must, except where a derogation has been agreed by common accord between the two organizations or associations concerned, be registered or entered in the appropriate studbook of the Member State of destination under the same name, with an indication, in accordance with international agreements, of the initial(s) of the country of foaling. 2. Where the constitution of the organizations or associations so permits: — the original name of the animal may be preceded or followed by another name on a provisional or permanent basis, provided that throughout the animal's life the original name is retained in brackets and that the country of birth is indicated by means of the initial(s) recognized by international agreements, — alternative measures may be taken to safeguard the continued identity of the animal in accordance with procedures to be determined by the Commission under the procedure laid down in Article 10. CHAPTER III Zootechnical rules relating to registered equidae Article 7 The Commission, may, in so far as may be necessary to ensure uniform application of the provisions of this Directive and in compliance with the principles laid down in Article 4 (1), determine in accordance with the procedure laid down in Article 10: (a) the methods of monitoring performance and assessing the genetic value of breeding animals; (b) on the basis of the methods referred to in (a), the general criteria for the approval of a male breeding animal or, if appropriate, of a female breeding animal for the purposes of breeding and using their semen, ova or embryos. Article 8 Member States shall ensure that: 1. in their movements, registered equidae are accompanied by an identification document drawn up by the Commission in accordance with the procedure laid down in Article 10 and issued by the organizations or associations referred to in Article 5 of this Directive and Article 2 (c) of Directive 90/426/EEC of 26 June 1990, on animal health conditions governing the movement between Member States and import from third countries of equidae (4). The identification document, to be drawn up in the Community languages, for registered horses must include at least the information indicated in the Annex; that information may be supplemented or amended in accordance with the procedure laid down in Article 10; 2. When they are marketed, the semen, ova and embryos of registered equidae are accompanied by a zootechnical certificate of origin and identification issued by the competent authority at least in the language of the country of destination and conforming to a model to be drawn up by the Commission in accordance with the procedure laid down in Article 10. Final provisions Article 9 Pending implementation of relevant Community rules, the conditions applicable to imports of equidae and their semen, ova and embryos from third countries must not be more favourable than those governing intra-Community trade. Article 10 Where the procedure laid down in this Article is to be used, the Standing Committee on Zootechnics set up by Decision 77/505/EEC (5), shall act in accordance with the rules set out in Article 11 of Directive 88/661/EEC (6). Article 11 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1991 at the latest. They shall forthwith inform the Commission thereof. Article 12 This Directive is addressed to the Member States.

31990L0425

1990

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 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 Community is to adopt measures designed to establish the internal market progressively over a period expiring on 31 December 1992; Whereas the harmonious operation of the common organization of the market in animals and products of animal origin implies the dismantling of zootechnical and veterinary barriers to the development of intra-Community trade in the animals and products concerned; whereas, in this respect, the free movement of animals and agricultural products is a fundamental feature of the common organization of markets and should facilitate the rational development of agricultural production and the optimum use of the factors of production; Whereas, in the veterinary field, frontiers are currently being used for carrying out checks aimed at safeguarding public health and animal health; Whereas the ultimate aim is to ensure that veterinary checks are carried out at the place of dispatch only; whereas the attainment of this objective implies the harmonization of the basic requirements relating to the safeguarding of animal health; Whereas, with a view to the completion of the internal market, pending the attainment of this objective, emphasis should be placed on the checks to be carried out at the place of dispatch and in organizing those that could be carried out at the place of destination; whereas such a solution would entail the suspension of veterinary checks at the Community's internal frontiers and whereas, in this context, there is good reason for retaining a health certificate or an identification document, as provided for in Community rules; Whereas this solution implies increased confidence in the veterinary checks carried out by the State of dispatch, in particular by the setting up of a system for the rapid exchange of information; whereas the dispatching Member State must ensure that such veterinary checks are carried out in an appropriate manner; Whereas, in the State of destination, spot veterinary checks could be carried out at the place of destination; whereas, however, in the event of a serious presumption of irregularity, the veterinary check could be carried out while the animals and products are in transit and whereas it is possible to continue to provide for the placing into quarantine in areas which have not been harmonized; Whereas provision must be made for action to be taken where a veterinary check discloses that the consignment is irregular; Whereas provision should be made for a procedure for resolving conflicts which could arise concerning consignments from a holding, centre or organization; Whereas provision must be made for protective measures; whereas in this area, especially for reasons of effectiveness, responsibility must rest firstly with the Member State of dispatch; whereas the Commission must be able to act speedily, in particular by way of on-the-spot visits and adopting measures appropriate to the situation; Whereas in order to be effective, the rules laid down by this Directive should cover all animals and products that are subject, in intra-Community trade, to veterinary requirements; Whereas, however, in view of the current state of harmonization and pending Community rules, animals and products that are not the subject of harmonized rules should comply with the requirements of the State of destination provided that the latter are in conformity with Article 36 of the Treaty; Whereas the abovementioned rules should be applied to zootechnical checks; Whereas the provisions of existing Directives should be adapted to the new rules laid down in this Directive; Whereas these rules should be re-examined before the end of 1993; Whereas the Commission should be entrusted with the task of adopting measures for applying this Directive; whereas, to that end, provision should be made for procedures establishing close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee, Article 1 Member States shall ensure that the veterinary checks to be carried out on live animals and products which are covered by the Directives listed in Annex A or on those referred to in the first paragraph of Article 21 and which are intended for trade are no longer carried out, without prejudice to Article 7, at frontiers but are carried out in accordance with this Directive. Member States shall further ensure that checks on zootechnical documents are subject to the control rules laid down by this Directive. This Directive shall affect neither checks on the welfare of animals during transport nor checks carried out as part of tasks conducted in a non-discriminatory manner by authorities responsible for the general application of laws in a Member State. Article 2 For the purposes of this Directive: 1. 'veterinary check' shall mean any physical check and/or administrative formality which applies to the animals or products referred to in Article 1 and which is intended for the protection, direct or otherwise, of public or animal health; 2. 'zootechnical check' shall mean any physical and/or administrative formality which applies to the animals covered by the Directives mentioned in section II of Annex A and which is intended for the direct or indirect improvement of the breeds; 3. 'trade' shall mean trade between Member States within the meaning of Article 9 (2) of the Treaty; 4. 'holding' shall mean an agricultural establishment or premises of a dealer, as defined by the national rules in force, situated in the territory of a Member State and in which the animals referred to in Annexes A and B, with the exception of equidae, are held or regularly kept and the holding as defined in Article 2 (a) of Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third countries of live equidae (4); 5. 'centre or organization' shall mean any undertaking which produces, stores, processes or handles the products referred to in Article 1; 6. 'competent authority' shall mean the central authority of a Member State competent to carry out veterinary or zootechnical checks or any authority to which it has delegated that competence; 7. 'official veterinarian' shall mean the veterinarian appointed by the competent authority. CHAPTER I Checks at origin Article 3 1. Member States shall ensure that only the animals and products referred to in Article 1 that fulfil the following conditions may be the subject of trade: (a) the animals and products referred to in Annex A must satisfy the requirements of the relevant Directives listed in the said Annex and the animals and products referred to in Annex B must fulfil the animal health requirements of the Member State of destination; (b) they must come from holdings, centres or organizations which are subject to regular official veterinary checks in accordance with paragraph 3; (c) they must, on the one hand, be identified in accordance with the requirements of Community rules and, on the other hand, be registered in such a way that the original or transit holding, centre or organization can be traced; national identification or registration systems must be notified to the Commission within three months of the date of notification of this Directive. Before 1 January 1993, Member States must take appropriate measures to guarantee that the identification and registration systems applicable to intra-Community trade are extended to the movement of animals within their territory; (d) they must, when transported, be accompanied by health certificates and/or any other documents as provided for in the Directives referred to in Annex A and, for the other animals and products, by the rules of the Member State of destination; Those certificates or documents, issued by the official veterinarian responsible for the holding, centre or organization of origin and, in the case of documents required by the zootechnical legislation referred to in section II of Annex A, by the competent authority, must accompany the animal, animals and products to its/their destination(s); (e) susceptible animals, or products of susceptible animals, must not originate: ii(i) from holdings, centres or organizations, areas or regions which are subject to restrictions determined in accordance with Community rules, where applicable, for the animals concerned or products from the animals concerned because of the suspicion, outbreak or existence of a disease referred to in Annex C or because of the application of safeguard measures; i(ii) from a holding, centre, organization, area or region which is the subject of official restrictions because of the suspicion, outbreak or existence of a disease other than those referred to in Annex C or of the application of safeguard measures; (iii) in cases where they are intended for holdings, centres or organizations situated in the Member States which have obtained the guarantees pursuant to Article 9 of Directive 64/432/EEC or other equivalent Community rules which have been or will be adopted or in a State recognized, by Community legislation, as free, in all or part of its territory, of a disease, from a holding which does not provide the guarantees which may be required by that Member State with respect to diseases other than those listed in Annex C; (iv) when they are intended for a Member State or part of the territory of a Member State which has benefited from the additional guarantees pursuant to Article 9 of Directive 64/432/EEC or other equivalent Community rules which have been or will be adopted, from a holding, centre or organization and, should the case arise, from a part of the territory which does not offer the additional guarantees provided for. The competent authority of the country of origin shall ensure, before issuing the certificate or accompanying document, that the holdings, centres or organizations comply with the requirements provided for in this point; (f) where the transport operation involves several places of destination, animals and products must be grouped together in as many consignments as there are places of destination. Each consignment must be accompanied by the certificates and/or documents referred to in (d); (g) where animals and products covered by the Directives referred to in Annex A which comply with Community rules are intended for export to a third country through the territory of another Member State, the transport operation must - except in cases of urgent need duly authorized by the competent authority in order to ensure the welfare of the animals - remain under customs supervision up to the point of exit from Community territory, in accordance with detailed arrangements to be drawn up by the Commission, acting under the procedure laid down in Article 18 or, where appropriate, in Article 19. Moreover, in the cases of animals and products not complying with Community rules or animals and products referred to in Annex B, transit may take place only if it has been expressly authorized by the competent authority of the Member State of transit. 2. Member States shall also ensure that: - the animals and products referred to in Article 1 which might have to be slaughtered under a national programme for the eradication of diseases not referred to in Annex C are not dispatched to the territory of another Member State; - the animals and products referred to in Annex A or the animals and products referred to in Annex B are not dispatched to the territory of another Member State if they cannot be marketed on their own territory for health or animal health reasons justified by Article 36 of the Treaty. 3. Without prejudice to the monitoring duties assigned to the official veterinarian under Community legislation, the competent authority shall carry out checks on holdings, approved markets and assembly centres, centres or organizations in order to satisfy itself that animals and products intended for trade comply with Community requirements and in particular fulfil the conditions laid down in paragraph 1 (c) and (d) with regard to identification. Where there are grounds for suspecting that Community requirements are not being met, the competent authority shall carry out the necessary checks and, if the suspicion is confirmed, take the appropriate measures, which may include isolation of the holding, centre or organization concerned. 4. Under the procedure laid down in Article 18 or, where appropriate, in Article 19, the Commission may adopt detailed rules for the application of this Article, in particular to take account of the species concerned. Article 4 1. Member States of dispatch shall take the necessary measures to ensure that: (a) the holders of livestock and products referred to in Article 1 comply with the national or Community health or zootechnical requirements referred to in this Directive at all stages of production and marketing; (b) the animals and products referred to in Annex A are checked at least as carefully, from a veterinary viewpoint, as if they were intended for the national market, unless specifically provided otherwise by Community rules; (c) animals are transported in suitable means of transport which satisfy hygiene rules. 2. The competent authority of the Member State of origin which issued the certificate or document accompanying the animals and products shall communicate, on the day on which they were issued and by means of the computerized system provided for in Article 20, to the central competent authority of the Member State of destination and to the competent authority of the place of destination, data to be determined by the Commission, according to the procedure provided for in Article 18. 3. Member States of dispatch shall take the appropriate measures to penalize any infringement of veterinary or zootechnical legislation by natural or legal persons where it is found that Community rules have been infringed, and in particular where it is found that certificates, documents or identification marks do not correspond to the status of the animals or to their holdings of origin or to the actual characteristics of the products. CHAPTER II Checks on arrival at destination Article 5 1. Member States of destination shall implement the following inspection measures: (a) the competent authority may, at the places of destination of animals and products, establish by means of non-discriminatory veterinary spot checks that the requirements of Article 3 have been complied with; it may take samples at the same time. Furthermore, checks may also be carried out during the transport of animals and products in its territory where the competent authority of the Member State of transit or of the Member State of destination has information leading it to suspect an infringement; (b) furthermore, where the animals referred to in Article 1 and originating in another State are intended: ii(i) for an approved market or assembly centre as defined by Community rules, the operator thereof shall be responsible for the admission of animals not meeting the requirements of Article 3 (1). The competent authority must check, by means of non-discriminatory inspections of the certificates or documents accompanying the animals, that the animals meet the said requirements; i(ii) for a slaughterhouse placed under the supervision of an official veterinarian, the latter must ensure, in particular on the basis of the certificate or accompanying document, that only animals that meet the requirements of Article 3 (1) are slaughtered. The operator of the slaughterhouse shall be responsible for slaughtering animals which do not meet the requirements of Article 3 (1) (c) and (d); (iii) for a registered dealer who divides up the consignments or for any establishment not subject to permanent supervision, such dealer or establishment shall be regarded by the competent authority as the consignee of the animals and the conditions laid down in the second subparagraph shall apply; (iv) for holdings, centres or organizations including, where the consignment is partly unloaded during transport, each animal or group of animals must be accompanied, in accordance with Article 3 by the original of the health certificate or accompanying document until it reaches the consignee mentioned therein. The consignees referred to in points (iii) and (iv) of the first subparagraph must, before the consignment is divided up or subsequently marketed, check that the identification marks, certificates or documents referred to in Article 3 (1) (c) and (d) are present, notify the competent authority of any irregularity or anomaly and, in the latter case, isolate the animals in question until the competent authority has taken a decision regarding them. The guarantees which must be furnished by the consignees referred to in points (iii) and (iv) of the first subparagraph shall be specified in an agreement with the competent authority to be signed at the time of the prior registration provided for in Article 12. The competent authority shall carry out random checks to verify compliance with those guarantees. This point shall apply mutatis mutandis to consignees of the products referred to in Article 1. 2. All the consignees appearing on the certificate or document provided for in Article 3 (1) (d): (a) must, at the request of the competent authority of the Member State of destination and to the extent necessary to carry out the checks referred to in paragraph 1, report in advance the arrival of animals and products from another Member State and, in particular, the nature of the consignment and the anticipated arrival date. However, the time limit for notification shall as a general rule not be more than one day; nevertheless, in exceptional circumstances, Member States may require two days' advance notification. This notification is not required for registered horses bearing an identification document provided for by Directive 90/427/EEC; (b) shall keep for a period of not less than six months, to be specified by the competent authority, the health certificates or documents referred to in Article 3 for presentation to the competent authority should the latter so request. 3. The detailed rules for implementing this Article shall be adopted in accordance with the procedure laid down in Article 18 or, where appropriate, in Article 19. Article 6 1. Where Community rules or, in areas which have not yet been harmonized, national provisions which comply with the general rules of the Treaty require that live animals be put into quarantine, the latter shall normally take place at the holding of destination. 2. A quarantine station may be used if this is justified from a veterinary viewpoint. Such station shall be regarded as the place of destination of the consignment. The Member State concerned shall notify the Commission of the grounds on which such action is being taken. 3. Obligations relating to quarantine and the location of the latter shall be specified in the veterinary requirements referred to in the second subparagraph of Article 21. Article 7 1. Member States shall ensure that during the checks carried out at the places where animals and products referred to in Article 1 from a third country may be brought into Community territory, such as ports, airports and frontier posts with third countries, the following measures are taken: (a) the certificates or documents accompanying the animals and products are checked; (b) where animals and products are imported from third countries, they must be sent, under customs supervision, to inspection posts in order that veterinary checks may be carried out. The animals and products referred to in Annex A may not be given customs clearance unless those checks have shown that they comply with Community rules; (c) Community animals and products shall be subject to the control rules laid down in Article 5. 2. The animals and products referred to in Annex B and those which are imported on the basis of national animal health standards must be brought directly into Community territory via one of the inspection posts of the Member State which intends to import them and be inspected there in accordance with paragraph 1 (b). Member States which make imports from third countries on the basis of national animal health rules shall inform the Commission and the other Member States, in particular Member States of transit, of the existence of such imports and of the requirements to which they subject such imports. Member States of destination shall prohibit animals from being sent on from their territory unless they have remained there for the periods laid down in the specific Community legislation and likewise the products referred to in the second subparagraph unless they are bound, without transit, for another Member State using the same option. However, pending the adoption of Community rules, those animals and products may be brought into the territory of a Member State other than that referred to in the second subparagraph following prior agreement given by that other Member State in a general manner and, where appropriate, by a Member State of transit on the arrangements for control. Member States shall inform the Commission and the other Member States in the framework of the Standing Veterinary Committee when they are making use of this derogation and of the control arrangements agreed upon. 3. However, from 1 January 1993 and by way of derogation from paragraph 1, all animals and products transported by regular, direct means of transport linking two geographical points of the Community shall be subject to the control rules laid down in Article 5. Article 8 1. If, during a check carried out at the place of destination of a consignment or during transport, the competent authorities of a Member State establish: (a) the presence of agents responsible for a disease referred to in Directive 82/894/EEC (5), as last amended by Commission Decision 90/134/EEC (6), a zoonosis or disease, or any cause likely to constitute a serious hazard to animals or humans, or that the products come from a region contaminated by an epizootic disease, they shall order that the animal or consignment of animals be put in quarantine at the nearest quarantine station or slaughtered and/or destroyed. Costs relating to the measures provided for in the first subparagraph shall be borne by the consignor or his representative or the person responsible for the products or animals. The competent authorities of the Member State of destination shall immediately notify the competent authorities of the other Member States and the Commission in writing, by the most appropriate means, of the findings arrived at, the decisions taken and the reasons for such decisions. The protective measures provided for in Article 10 may be applied. At a Member State's request and in accordance with the procedure laid down in Article 17, the Commission may, moreover, adopt any measure necessary for achieving a concerted approach by the Member States to deal with situations not covered by Community rules; (b) that, without prejudice to point (a), the animals and products do not meet the conditions laid down by Community Directives or, where the Member State obtains the guarantees pursuant to Article 9 of Directive 64/432/EEC or equivalent Community rules which have been or will be adopted, by national animal health rules, they may, provided that public or animal health considerations so permit, give the consignor or his representative the choice of: - maintenance of the animals and products under supervision until compliance with rules is confirmed where residues are present, and, in the event of failure to comply with those rules, application of the measures provided for by Community legislation, - slaughtering of the animals or the destruction of the products, - return of the animal or consignment, with the authorization of the competent authority of the Member State of dispatch and prior notification of the Member State(s) of transit. However, if the certificate or documents are found to contain irregularities, the owner or his representative must be granted a period of grace before recourse is had to this last possibility. 2. In accordance with the procedure laid down in Article 18, the Commission shall draw up a list of the diseases referred to in paragraph 1 and detailed rules for the application of this Article. Article 9 1. In the cases provided for in Article 8, the competent authority of the Member State of destination shall contact the competent authorities of the Member State of dispatch without delay. The latter authorities shall take all necessary measures and notify the competent authority of the first Member State of the nature of the checks carried out, the decisions taken and the reasons for such decisions. If the competent authority of the Member State of destination fears that such measures are inadequate, the competent authorities of the two Member States shall together seek ways and means of remedying the situation; if appropriate, this may involve an on-the-spot inspection. Where the checks provided for in Article 8 show repeated irregularities, the competent authority of the Member State of destination shall inform the Commission and the competent authorities of the other Member States. The Commission, at the request of the competent authority of the Member State of destination or on its own initiative, and taking into account the nature of the infringements established, may: - send inspectors, in collaboration with the competent national authorities, to the place concerned, - instruct an official veterinarian, whose name shall be on a list to be prepared by the Commission at the suggestion of the Member States, and who is acceptable to the various parties concerned, to check the facts on the spot, - request the competent authority to intensify checks on the holding, the centre, the organization, the approved market or assembly centre or the region of origin. It shall inform the Member States of its findings. Pending the Commission's findings, the Member State of dispatch must, at the request of the Member State of destination, intensify checks on animals and products coming from the holding, centre, organization, approved market or assembly centre or region in question, and if there are serious public or animal health grounds, suspend issue of any certificates or movement documents. The Member State of destination may, for its part, intensify checks on animals coming from the same holding, centre, organization, approved market or assembly centre or region. At the request of one of the two Member States concerned - where the irregularities are confirmed by the expert's opinion - the Commission must, in accordance with the procedure laid down in Article 17, take the appropriate measures, which may go as far as authorizing the Member States to prohibit provisionally the bringing into their territory of animals and products coming from that holding, centre, organization, approved market or assembly centre or region. These measures must be confirmed or reviewed as soon as possible in accordance with the procedure laid down in Article 17. 2. Except in cases provided for in the fourth subparagraph, rights of appeal existing under the laws in force in the Member States against decisions by the competent authorities shall not be affected by this Directive. Decisions taken by the competent authority of the State of destination and the reasons for such decisions shall be notified to the consignor or his representative and to the competent authority of the Member State of dispatch. If the consignor or his representative so requests, the said decisions and reasons shall be forwarded to him in writing with details of the rights of appeal which are available to him under the law in force in the Member State of destination and of the procedure and time limits applicable. However, in the event of a dispute, the two parties concerned may, if they so agree, within a maximum period of one month, submit the dispute for the assessment of an expert whose name appears on a list of Community experts to be drawn up by the Commission; the cost of consulting the expert shall be borne by the Community. Such experts shall issue their opinions within not more than 72 hours or after receiving the results of any analyses. The parties shall abide by the expert's opinion, with due regard for Community veterinary legislation. 3. The costs of returning the consignment, holding or isolating the animals or, if appropriate, slaughtering or destroying them shall be borne by the consignor, his representative or the person responsible for the animals or products. 4. The detailed rules for the application of this Article shall be adopted in accordance with the procedure laid down in Article 18 or, where appropriate, in Article 19. CHAPTER III Common provisions Article 10 1. Each Member State shall immediately notify the other Member States and the Commission of any outbreak in its territory, in addition to an outbreak of diseases referred to in Directive 82/894/EEC, of any zoonoses, diseases or other cause likely to constitute a serious hazard to animals or to human health. The Member State of dispatch shall immediately implement the control or precautionary measures provided for in Community rules, in particular the determination of the buffer zones provided for in those rules, or adopt any other measure which it deems appropriate. The Member State of destination or transit which, in the course of a check referred to in Article 5, has established the existence of one of the diseases or causes referred to in the first subparagraph may, if necessary, take the precautionary measures provided for in Community rules, including the quarantining of the animals. Pending the measures to be taken in accordance with paragraph 4, the Member State of destination may, on serious public or animal health grounds, take interim protective measures with regard to the holdings, centres or organizations concerned or, in the case of an epizootic disease, with regard to the buffer zone provided for in Community rules. The measures taken by Member States shall be notified to the Commission and to the other Member States without delay. 2. At the request of the Member State referred to in the first subparagraph of paragraph 1 or on the initiative of the Commission, one or more Commission representatives may go at once to the place concerned to examine, in collaboration with the competent authorities, what measures have been taken, and shall issue an opinion on those measures. 3. If the Commission has not been informed of the measures taken, or if it considers the measures taken to be inadequate, it may, in collaboration with the Member State concerned and pending the meeting of the Standing Veterinary Committee, take interim protective measures with regard to animals or products from the region affected by the epizootic disease or from a given holding, centre or organization. These measures shall be submitted to the Standing Veterinary Committee as soon as possible to be confirmed, amended or cancelled in accordance with the procedure laid down in Article 17. 4. The Commission shall in all cases review the situation in the Standing Veterinary Committee at the earliest opportunity. It shall adopt the necessary measures for the animals and products referred to in Article 1 and, if the situation so requires, for the products derived from those animals, in accordance with the procedure laid down in Article 17. The Commission shall monitor the situation and, by the same procedure, shall amend or repeal the decisions taken, depending on how the situation develops. 5. Detailed rules for the application of this Article, and in particular the list of zoonoses or causes likely to constitute a serious hazard to human health, shall be adopted in accordance with the procedure laid down in Article 18. Article 11 Each Member State and the Commission shall appoint the veterinary department or departments responsible for carrying out the veterinary checks and collaborating with the other Member States' inspection departments. Article 12 Member States shall ensure that all dealers engaging in intra-Community trade in the animals and/or products covered by Article 1: (a) are required, at the request of the competent authority, to register beforehand in an official register; (b) keep a record of deliveries and, for the consignees referred to in Article 5 (1) (b) (iii), of the subsequent destination of the animals and products. The said record shall be preserved for a period to be determined by the competent national authority so that it can be presented to the competent authority on request. Article 13 The Member States shall also ensure that the officials of their veterinary departments, if appropriate in collaboration with the officials of other departments empowered to that end, are able in particular to: - carry out inspections of holdings, installations, means of transport and processes used for the marking and identification of animals, - check, as regards the products listed in Annex A, that the personnel are complying with the requirements laid down in the texts referred to in that Annex, - take samples from: i(i) animals held with a view to being sold, put on the market or transported; (ii) products held with a view to being stored or sold, put on the market or transported, - examine documentary or data processing material relevant to the checks carried out further to the measures taken under this Directive. Member States must require the holdings, centres or organizations being checked to afford the collaboration necessary for the performance of the aforementioned tasks. Article 14 1. Directive 64/432/EEC (7), as last amended by Directive 89/662/EEC (8), is hereby amended as follows: (a) Article 6 is replaced by the following: 'Article 6 Animals for slaughter which have been taken on arrival in the country of destination either directly or via an approved market or assembly centre to a slaughterhouse must be slaughtered there as soon as possible, in accordance with animal health requirements. Animals for slaughter which have been taken on arrival in the country of destination to a market adjoining a slaughterhouse under whose rules all animals may be removed, in particular after the market, only to a slaughterhouse approved for this purpose by the competent central authority must be slaughtered at that slaughterhouse not later than five days after arriving at the market. The competent authority of the country of destination may, in the light of animal health considerations, designate the slaughterhouse to which those animals must be sent.' (b) Article 7 (3) and the first subparagraph of Article 8 (2) are hereby deleted. (c) Articles 9 and 10 are replaced by the following: 'Article 9 1. A Member State which has a national control programme for one of the contagious diseases not referred to in Annex E for all or part of its territory may submit the said programme to the Commission, outlining in particular: - the distribution of the disease in the Member State, - the reasons for the programme, taking into consideration the importance of the disease and the programme's likely benefit in relation to its cost, - the geographical area in which the programme will be implemented, - the status categories to be applied to the animal establishments, the standards which must be attained in each category, and the test procedures to be used, - the programme monitoring procedures, - the action to be taken if, for any reason, an establishment loses its status, - the measures to be taken if the results of the tests carried out in accordance with the provisions of the programme are positive. 2. The Commission shall examine the programmes presented by the Member States. Programmes as referred to in paragraph 1 may be approved in compliance with the criteria laid down in paragraph 1 in accordance with the procedure provided for in Article 12. According to the same procedure, the additional guarantees, general or limited, which may be required in intra-Community trade, shall be defined at the same time or at the latest three months after approval 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 in accordance with the procedure laid down in Article 12. Amendments or additions to programmes which have already been approved or to guarantees which have been defined in accordance with paragraph 2 may be approved under the same procedure. Article 10 1. Where a Member State considers that its territory or part of its territory is free from one of the diseases to which bovine animals and swine 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 and on the fact that the disease must by law be notified 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 documentation submitted by Member States. The additional guarantees, general or specific, which may be required in intra-Community trade may be defined in accordance with the procedure laid down in Article 12. Such guarantees must not exceed those which the Member State implements nationally. Where justification is submitted before 1 July 1991, decisions on additional guarantees shall be taken before 1 January 1992. 3. The Member State concerned shall notify the Commission of any change in the particulars specified in paragraph 1 which relate to the disease. The guarantees defined as laid down in paragraph 2 may, in the light of such notification, be amended or withdrawn in accordance with the procedure laid down in Article 12.' 2. Subparagraphs 2 to 5 of Article 5 (2) and Articles 7 and 15 of Directive 88/407/EEC (9) are hereby deleted. 3. Subparagraphs 2 to 4 of Article 5 (2) and Article 14 of Directive 89/556/EEC (10) are hereby deleted. 4. In the fifth line of the first subparagraph of Article 13 of Directive 72/462/EEC (11), as last amended by Directive 89/227/EEC (12), 'three' is replaced by 'five'. Article 15 1. The following Article is inserted in Directives 64/432/EEC and 89/556/EEC: 'Article 14 The rules laid down in Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks in intra-Community trade in certain live animals and products with a view to the completion of the internal market (*), shall apply in particular to checks at origin, to the organization of, and follow-up to, the checks to be carried out by the country of destination, and to the safeguard measures to be implemented. (*) OJ No L 224, 18. 8. 1990, p. 29. 2. The following Article is inserted in Directive 88/407/EEC: 'Article 15 The rules laid down in Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks in intra-Community trade in certain live animals and products with a view to the completion of the internal market (*), shall apply in particular to checks at origin, to the organization of, and follow-up to, the checks to be carried out by the Member State of destination, and follow up to, the checks to be carried out by the Member State of destination, and to the safeguard measures to be implemented. (*) OJ No L 224, 18. 8. 1990, p. 29. 3. Article 9 of Directive 90/426/EEC is replaced by the following: 'Article 9 The rules laid down in Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks in intra-Community trade in certain live animals and products with a view to the completion of the internal market (*), shall apply in particular to checks at origin, to the organization of, and follow-up to, the checks to be carried out by the Member State of destination, and to the safeguard measures to be implemented. (*) OJ No L 224, 18. 8. 1990, p. 29. Article 16 The Commission may, in accordance with the procedure laid down in Article 18, amend the list of diseases referred to in Annex C. Article 17 Where reference is made to the procedure provided for in this Article, the Standing Veterinary Committee set up by Decision 68/361/EEC (13) shall take decisions in accordance with the rules established in Article 17 of Directive 89/662/EEC. Article 18 Where reference is made to the procedure defined in this Article, the Standing Veterinary Committee shall take decisions in accordance with Article 18 of Directive 89/662/EEC. Article 19 Where reference is made to the procedure defined in this Article, the Standing Zootechnical Committee set up by Decision 77/505/EEC (14) shall take decisions in accordance with the rules established in Article 11 of Directive 88/661/EEC (15). CHAPTER IV Final and transitional provisions Article 20 1. The Commission shall introduce, in accordance with the procedure laid down in Article 18, a computerized system linking veterinary authorities, with a view, in particular, to facilitating the exchange of information between the competent authorities of regions where a health certificate or document accompanying the animals and products of animal origin has been issued and the competent authorities of the Member State of destination. 2. The procedures for the Community's financial contribution, as provided for in Article 37 of Decision 90/424/EEC and necessary for the implementation of this programme, shall be adopted in accordance with the procedure provided for in Article 42 of the said Decision. 3. According to the procedure provided for in Article 18, the Commission shall adopt the procedure for applying this Article and, in particular, the appropriate standards for the exchange of data and rules for the security of data exchanged. Article 21 Until 31 December 1992, trade in the animals and products listed in Annex B shall, pending the adoption of Community rules, and without prejudice to the maintenance of any national rules laid down for the identification of batches, be subject to the control rules laid down by this Directive, in particular those mentioned in the second part of the sentence of Article 3 (1) (a). Member States shall communicate to the Commission and the other Member States, before the date laid down in Article 22, the conditions and procedures currently applicable to admission to their territory of the animals and products referred to in the first paragraph, including the rules for identification. In accordance with the procedure laid down in Article 17, the Commission shall determine the measures necessary for the computerization of the statements of conditions mentioned in the second subparagraph. The control rules provided for the animals and products referred to in Annex A shall be extended to the animals and products of animal origin not yet covered by this Annex when the harmonized rules governing trade therein are adopted. Before 1 January 1992 the Council shall decide on the inclusion on 31 December 1992 in the scope of Directive 89/662/EEC and of this Directive of the animals and products of animal origin not covered by the said Directives. Article 22 1. Member States shall submit to the Commission before 1 October 1991 a programme setting out the national measures which they intend to take to achieve the stated objectives of this Directive, in particular the frequency of checks. 2. The Commission shall examine the programmes communicated by the Member States in accordance with paragraph 1. 3. Each year, and for the first time in 1992, the Commission shall address to the Member States a recommendation on a programme of checks for the following year; the Standing Veterinary Committee will have expressed its opinion on the recommendation in advance. This recommendation may be subject to later adaptations. Article 23 1. Before 1 January 1991, the Council, acting by a qualified majority on a proposal from the Commission, shall decide on the rules and general principles applicable upon checks to be carried out in third countries and upon checks on imports from third countries of animals and products covered by this Directive. In the same way, the check posts at the external frontiers, as well as the requirements to be satisfied by those posts, shall be fixed before that date. 2. Before 1 January 1993, the Council shall, on the basis of a report from the Commission on the experience gained, accompanied by any relevant proposals, on which it will decide by a qualified majority, review the provisions of this Directive, and in particular those of Article 10 and Article 5 (2) (a). Article 24 Until 31 December 1992 or at the latest 12 months after the date on which Member States have to conform to Directive 90/423/EEC, and in order to permit the gradual implementation of the checking arrangements laid down by this Directive, Member States may, by way of derogation from Article 5 (1): - maintain documentary checks during transport of animals and products covered by Annexes A and B in order to satisfy themselves that the specific requirements laid down by Community rules have been complied with, - operate documentary checks during transport on animals and products imported from third countries and intended for them. Article 25 The Council, acting by a qualified majority on a proposal from the Commission, shall determine, before 1 October 1992, the arrangements which are to apply when the transitional provisions provided for in Article 24 expire. Article 26 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with: i(i) Article 10 of this Directive and Article 9 of Directive 89/662/EEC, two months after the date of notification of this Directive; (ii) the other provisions of this Directive, at a date to be set when the Decision to be adopted before 31 December 1990 but not later than 31 December 1991 is taken. However, the Hellenic Republic shall have an additional time limit of one year in which to conform to these other provisions. Article 27 This Directive is addressed to the Member States.

31990L0426

1990

Council Directive 90/426/EEC of 26 June 1990 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), Whereas equidae, being live animals, are included in the list of products in Annex II to the Treaty; Whereas in order to ensure the rational development of equidae production, thereby increasing productivity in that sector, rules governing the movement of equidae between Member States must be laid down at Community level; Whereas the breeding and rearing of equidae and in particular of horses is generally included in the farming sector; whereas it constitutes a source of income for part of the farming population; Whereas disparities as regards animal health conditions in the Member States should be eliminated in order to encourage intra-Community trade in equidae; Whereas, in order to encourage the harmonious development of intra-Community trade, a Community system should be laid down to govern imports from third countries; Whereas the conditions for the movement on national territory of equidae bearing an identification document should also be regulated; Whereas, in order to be the subject of trade, equidae must satisfy certain animal health requirements, so as to avoid the spreading of contagious diseases; whereas it appears in particular appropriate to provide for a possible regionalization of restrictive measures; Whereas transport conditions should be laid down for the same reason; Whereas, to ensure that those requirements are satisfied provision must be made for the issue by an official veterinarian of a health certificate to accompany the equidae to their place of destination; Whereas 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 should be fixed within the framework of rules to be laid down for veterinary checks in intra-Community trade in live animals in view of the completion of the internal market; Whereas provision should be made for the possibility of checks by the Commission; whereas these checks should be carried out in cooperation with the competent national authorities; Whereas defining Community provisions applicable to imports from third countries requires a list to be drawn up of third countries or parts of third countries from which equidae may be imported; Whereas the choice of these countries must be based on criteria of a general nature such as the state of health of the livestock, the organization and powers of the veterinary services and the health regulations in force; Whereas, in addition, imports of equidae should not be authorized from countries infected with contagious or infectious animal diseases which present a risk to Community livestock or which have been free from such infection for too short a period; whereas such considerations are also valid for imports from third countries in which vaccination against such diseases is carried out; Whereas the general conditions applicable to imports from third countries must be supplemented by special conditions drawn up on the basis of the health situation in each of them; whereas the technical nature and the diversity of the criteria on which these special conditions depend require for their definition recourse to a flexible and rapid Community procedure in which the Commission and the Member States cooperate closely; Whereas the presentation of a common standard form of certificate upon import of equidae constitutes an effective means of verifying that the Community rules are being applied; whereas such rules may include special provisions which may vary according to the third country concerned, and whereas this must be taken into account in drawing up the standard forms of certificates; Whereas official Community veterinarians should be responsible for verifying that the requirements of this Directive are observed, particularly in third countries; Whereas the checks carried out upon importation must cover the origin and the state of health of the equidae; Whereas the Member States must be allowed, on the arrival of equidae in the territory of the Community and during transit to their place of destination, to take all measures, including slaughter and disposal, required for the purpose of safeguarding the health of humans and animals; Whereas the general rules applicable to the checks to be carried out on importation must be defined within an overall context; Whereas every Member State must have the right to place an immediate prohibition on imports from a third country when such imports may be dangerous for animal health; whereas in such a case coordination of the attitudes of the Member States with regard to that third country must be assured without delay, without prejudice to possible amendments to the list of countries authorized to export to the Community; Whereas the provisions of this Directive should be revised in connection with the completion of the internal market; Whereas provision should be made for a procedure establishing close and effective cooperation between the Commission and the Member State within the Standing Veterinary Committee, CHAPTER 1 General provisions Article 1 This Directive lays down animal health conditions for the movement between Member States and import from third countries of live equidae. Article 2 For the purposes of this Directive: (a) 'holding' means an agricultural or training establishment, a stable or, generally speaking, any premises or facilities in which equidae are habitually kept or bred, for whatever use; (b) 'equidae' means wild or domesticated animals of the equine (including zebras) or asinine species or the offspring of crossings of those species; (c) 'registered equidae' means any equidae registered as defined in Directive 90/427/EEC (4), identified by means of an identification document issued by the breeding authority or any other competent authority of the country where the animal originated which manages the studbook or register for that breed of animal or any international association or organization which manages horses for competition or racing; (d) 'equidae for slaughter' means equidae intended to be transported either directly or after transit through a market or an approved marshalling centre to the slaughterhouse for slaughter; (e) 'equidae for breeding and production' means equidae other than those mentioned in (c) and (d); (f) 'Member State or third country free from African horse sickness' means any Member State or third country in which there has been no clinical, serological (in unvaccinated equidae) or epidemiological evidence of African horse sickness on the territory concerned in the previous two years and in which there have been no vaccinations against the disease during the previous 12 months; (g) 'compulsorily notifiable diseases' means the diseases listed in Annex A; (h) 'official veterinarian' means the veterinarian designated by the competent central authority of a Member State or of a third country; (i) 'temporary admission' means the status of a registered animal originating in a third country and admitted into Community territory for a period of less than 90 days to be fixed by the Commission in accordance with the procedure laid down in Article 24, depending on the health situation in the country of origin. CHAPTER II Rules for the movement of equidae Article 3 Member States shall authorize the movement of equidae registered in their territory or send equidae to another Member State only where they satisfy the conditions laid down in Articles 4 and 5. However, the competent authorities in Member States of destination may grant general or limited exemption in respect of movement of equidae which: - are being ridden or taken, for sporting or recreational purposes, along roads situated near internal borders of the Community, - are taking part in cultural or similar events or in activities organized by authorized local bodies situated near internal borders of the Community, - are intended solely for temporary pasturing or work near internal borders of the Community. Member States making use of such authorization shall inform the Commission of the content of the exemptions granted. Article 4 1. Equidae must show no clinical sign of disease at inspection. Inspection must be carried out in the 48 hours prior to their embarkation or loading. In the case of registered equidae, however, this inspection shall, without prejudice to Article 6, be required for intra-Community trade only. 2. Without prejudice to the requirements of paragraph 5 regarding compulsorily notifiable diseases, the official veterinarian must, at the time of inspection, be satisfied that there are no grounds - in particular on the basis of declarations by the owner or breeder - for concluding that the equidae have been in contact with equidae suffering from an infectious or contagious disease during the 15 days immediately preceding inspection. 3. The equidae must not be intended for slaughter under a national programme of contagious or infectious disease eradication. 4. The equidae must be identified in the following manner: i(i) in the case of registered horses, by means of an identification document, as provided for in Directive 90/427/EEC (5), which must certify in particular that Article 5 (5) and (6) have been complied with. The offical veterinarian will have to suspend the validity of this document for the period of the prohibitions provided for in paragraph 5 or in Article 5. The document should, following the slaughter of the registered horse, be returned to the authority which issued it. The procedure for the implementation of this point shall be adopted by the Commission in accordance with the procedure laid down in Article 24; (ii) for equidae for breeding and production, identification by a method to be established by the Commission in accordance with the procedure laid down in Article 24. Until such time as this method is in use, the officially approved national identification methods shall remain applicable, provided that they are notified to the Commission and the other Member States within three months of the date on which this Directive is adopted. 5. In addition to the requirements laid down in Article 5, the equidae must not come from a holding which has been the subject of one of the following prohibition orders: (a) if all the animals of species susceptible to the disease located on the holding have not been slaughtered, the period of prohibition concerning the holding of origin must be at least: - six months in the case of equidae suspected of having contracted dourine, beginning on the date of the last actual or possible contact with a sick animal. However, in the case of a stallion, the prohibition shall apply until the animal is castrated, - six months in the case of glanders or equine encephalomyelitis, beginning on the day on which the equidae suffering from the disease in question are slaughtered, - in the case of infectious anaemia, until the date on which, the infected animals having been slaughtered, the remaining animals have shown a negative reaction to two Coggins tests carried out three months apart, - six months in the case of vesicular stomatitis, - one month from the last recorded case, in the case of rabies, - 15 days from the last recorded case, in the case of anthrax; (b) if all the animals of species susceptible to the disease located on the holding have been slaughtered and the premises disinfected, the period of prohibition shall be 30 days, beginning on the day on which the animals were destroyed and the premises disinfected, except in the case of anthrax, where the period of prohibition is 15 days. The competent authorities may derogate from these prohibition measures for hippodromes and racecourses, and shall notify the Commission of the nature of any derogations granted. 6. Where a Member State draws up or has drawn up a voluntary or compulsory control programme for a disease to which equidae are susceptible, it may present the programme to the Commission, within six months of notification of this Directive outlining in particular: - the distribution of the disease on its territory, - the reasons for the programme, taking into consideration the significance of the disease and its cost/benefit advantages, - the geographical area in which the programme will be implemented, - the status categories to be applied to establishments, the standards which must be attained for each species and the test procedures to be used, - the programme monitoring procedures, - 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 in accordance with the provisions of the programme are positive, - the non-discriminatory nature of trade in the territory of the Member State concerned with respect to intra-Community trade. The Commission shall examine the programmes presented by the Member States. Where appropriate it shall approve them in accordance with the procedure laid down in Article 24. Any additional guarantees, general or specific, which may be required in intra-Community trade may be defined in accordance with the same procedure. Such guarantees must not exceed those required by the Member State in its own territory. Programmes submitted by Member States may be amended or supplemented in accordance with the procedure laid down in Article 25. Amendments or additions to programmes which have already been approved or to guarantees which have been defined in accordance with the second subparagraph may be approved under the same procedure. 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, - 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 of at least 50 km extending beyond the protection zone, in which no vaccination has been carried out in the last 12 months. (c) The zones referred to in (b) must be clearly defined and take account of the geographical, ecological and epizootic factors connected with this epizootic disease. (d) All vaccinated equidae found in the protection zone must be registered and identified at the time of vaccination by a clear, indelible mark, recognizable in accordance with the procedure laid down in Article 24. The identification document and/or health certificate shall carry a clear reference to such vaccination. (e) Equidae and their movements within the zones referred to in (b) must be subject to proper veterinary control under the responsibility of the competent central authority. Only equidae meeting the requirements laid down in paragraph 3 may leave the zones referred to in (b). 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 despatch; (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 despatch. 4. On a transitional basis and pending the introduction of Community measures to harmonize rules for controlling and measures to combat African horse sickness, to be decided on by the Council acting before 1 July 1991 by a qualified majority on a proposal from the Commission, the Commission shall, in accordance with the procedure laid down in Article 25, determine the limits of the infected territory in accordance with paragraph 1 (b) before 1 November 1990. 5. The Commission may, acting in accordance with the procedure laid down in Article 25, amend the decision taken in accordance with paragraph 4, in the light of epidemiological circumstances. 6. The Council, acting by a qualified majority on a proposal from the Commission based on a report on experience acquired, shall if necessary review this Article within a period of two years. Article 6 Member States which implement an alternative control system providing guarantees equivalent to those laid down in Article 4 (5) as regards movements within their territory of equidae and registered equidae, in particular by means of the identification document, may grant one another derogations from the provisions of the second sentence of Article 4 (1) and the second indent of Article 8 (1) on a reciprocal basis. They shall notify the Commission thereof. Article 7 1. The equidae must be transported, as soon as possible, from the holding of origin either directly or via an approved market or marshalling centre as defined in Article 3 (6) of Directive 64/432/EEC to the place of destination in vehicles or containers which have been regularly cleansed and disinfected with a disinfectant at intervals to be fixed by the Member State of dispatch. The vehicles must be designed in such a way that equidae droppings, litter or fodder cannot escape from the vehicle during transportation. Transportation must be effected in such a way that the health and well-being of the equidae can be protected effectively. 2. The Member State of destination may, on a general or restricted basis, grant a derogation from some of the requirements of Article 4 (5) for any animal bearing a special mark indicating that it is scheduled for slaughter, provided that the health certificate mentions such derogation. In the case of granting such a derogation equidae for slaughter must be transported directly to the designated slaughterhouse and be slaughtered within five days of arrival at the slaughterhouse. 3. The official veterinarian must record the identification number or identification document number of the slaughtered animal and forward to the competent authority of the place of dispatch, at the latter's request, an attestation to the effect that the animal has been slaughtered. Article 8 1. Member States shall ensure that: - registered equidae which leave their holdings are accompanied by the identification document laid down in Article 4 (4) together - if they are intended for intra-Community trade - with the attestation provided for in Annex B, - equidae for breeding, production and slaughter are, during their transportion, accompanied by a health certificate complying with Annex C to this Directive. The certificate, or in the case of an identification document, the form containing the health particulars, must, without prejudice to Article 6, be drawn up during the 48 hours preceding their embarkation or else no later than the last working day prior to it, in at least one of the official languages of the Member States of dispatch and destination. The duration of validity of the certificate is 10 days. The certificate must consist of a single sheet. 2. Imports of equidae other than registered equidae may be covered by a single health certificate per consignment rather than by the individual certificate referred to in the second indent of paragraph 1. Article 9 The rules on checks and safeguard measures applicable to intra-Community trade in equidae shall be adopted by the Council under its Decision on veterinary checks applicable to intra-Community trade in live animals with a view to the completion of the internal market. Article 10 Veterinary experts from the Commission may, to the extent necessary to ensure uniform application of this Directive and in cooperation with the competent national authorities, carry out on-the-spot inspections. The Commission shall inform the Member States of the outcome of such inspections. The Member States in whose territory an inspection is carried out shall give the experts all the assistance necessary to carry out their task. General arrangements for the application of this Article shall be adopted in accordance with the procedure laid down in Article 24. CHAPTER III Rules for imports from third countries Article 11 1. Equidae imported into the Community must satisfy the conditions laid down in Articles 12 to 16. 2. Until the date of entry into force of the decisions adopted pursuant to Articles 12 to 16, the Member States shall apply to imports of equidae from third countries conditions at least equivalent to those resulting from the application of Chapter II. Article 12 1. In order to be imported, the equidae must come from a third country or part of a third country appearing on a list included in a separate column to be added to the list drawn up in accordance with Article 3 of Directive 72/462/EEC. 2. The procedures and criteria for the preparation, modification and publication of the list of third countries or parts of third countries provided for in Article 3 of Directive 72/462/EEC shall apply to the list applicable to imports of equidae. Article 13 1. The equidae must come from third countries: (a) free from African horse sickness; (b) which have been free for two years from Venezuelan equine encephalomyelitis (VEE); (c) which have been free for six months from dourine and glanders. 2. The Commission may, in accordance with the procedure laid down in Article 24: (a) decide that the provisions of paragraph 1 shall apply to only a part of the territory of a third country. In the event that the African horse sickness requirements apply on a regional basis, at the very least the measures laid down in Article 5 (2) and (3) must be complied with; (b) require additional guarantees for diseases alien to the Community. Article 14 Before the day of loading for transportation to the Member State of destination, the equidae must have remained without interruption in the territory or part of the territory of a third country or, in the event of regionalization, in the part of the territory defined pursuant to Article 13 (2) (a) for a period to be determined in the decisions to be adopted pursuant to Article 15. They must come from a holding placed under veterinary supervision. Article 15 Importation of equidae from the territory of a third country or part thereof as defined in accordance with Article 13 (2) (a) on the list drawn up in accordance with Article 12 (1) shall be authorized only if the equidae, over and above the requirements of Article 13: (a) comply with the animal health requirements adopted, with reference to the species in question and the categories of equidae, in accordance with the procedure laid down in Article 24 for imports of equidae from that country. The reference basis for fixing animal health conditions in accordance with paragraph 1 shall be the standards laid down in Articles 4 and 5; and (b) in the case of a third country not free of vesicular stomatitis or viral arteritis for at least six months, the equidae must meet the following requirements: i(i) they must come from a holding which has been free of vesicular stomatitis for at least six months and they must have reacted negatively to a serological test prior to dispatch; (ii) in the case of viral arteritis, male equidae must - notwithstanding Article 19 (ii) - have reacted negatively to a serological test or to a virus isolation test or to any other test recognized in accordance with the procedure laid down in Article 24 which would guarantee freedom from the virus. In accordance with the procedure laid down in Article 24, and following the opinion of the Scientific Veterinary Committee, the Commission may define the categories of male equidae to which this requirement shall apply. Article 16 1. The equidae must be identified in accordance with Article 4 (4) and accompanied by a certificate drawn up by an official veterinarian of the exporting third country. This certificate must: (a) be issued on the day of loading of the animals for dispatch to the Member State of destination or, in the case of registered horses, on the last working day before embarkation; (b) be drawn up in at least one of the official languages of the Member States of destination and one of those of the Member State in which the import inspection is carried out; (c) accompany the animals in the original; (d) attest that the animals satisfy the requirements of this Directive and those laid down pursuant to this Directive with regard to importation from third countries; (e) consist of a single sheet; (f) be made out for a single consignee or, in the case of animals for slaughter, for a consignment, provided the animals are properly marked and identified. Member States shall inform the Commission if they make use of this option. 2. The certificate must be drawn up on a form complying with a model established in accordance with the procedure laid down in Article 24. Article 17 Checks shall be carried out on the spot by veterinary experts of the Member States and the Commission to verify whether the provisions of this Directive, and in particular those of Article 12 (2), are being applied in practice. Should checks carried out within the terms of this Article bring to light serious facts as against an approved holding, the Commission shall immediately inform the Member States and forthwith adopt a decision provisionally suspending the approval. The final decision shall be taken according to the procedure provided for in Article 25. The experts from the Member States who are to be entrusted with these checks shall be appointed by the Commission, acting on a proposal from the Member States. These checks shall be made on behalf of the Community, which shall bear the cost of any expenditure incurred in this connection. The frequency of and the procedure for these checks shall be determined in accordance with the procedure laid down in Article 24. Article 18 1. Immediately upon arrival in the Member State of destination, equidae for slaughter shall be taken to a slaughterhouse, either directly or after transition through a market or a marshalling centre, and, in accordance with animal health requirements, be slaughtered within a period of time specified in the decisions to be adopted pursuant to Article 15. 2. Without prejudice to any special conditions which may be adopted in accordance with the procedure laid down in Article 24, the competent authority of the Member State of destination may, on animal health grounds, designate the slaughterhouse to which such equidae must be taken. Article 19 The Commission, acting in accordance with the procedure laid down in Article 24: ii(i) may decide that imports from a third country or part of a third country are to be confined to particular species or categories; i(ii) shall, notwithstanding Article 15, establish the special conditions for the temporary entry into Community territory of registered equidae or equidae intended for special uses or their re-entry into Community territory after being temporarily exported; (iii) shall determine the conditions for converting temporary entry into permanent entry. Article 20 1. The general procedures applicable during checks to be carried out in third countries or during checks on imported equidae from third countries shall be determined by the Council not later than 31 December 1990. Pending implementation of the decision referred to in the first subparagraph, the national rules shall remain in force, in compliance with the general rules of the Treaty. 2. Equidae may not be imported if, during the import checks prescribed in paragraph 1, it is found that: - the equidae do not come from the territory of a third country or part thereof as defined pursuant to Article 13 (2) (a) included in the list drawn up in accordance with Article 12 (1), - the equidae are, or are suspected of being, infected with or contaminated by an infectious or contagious disease, - the conditions laid down in this Directive have not been complied with by the exporting third country, - the certificate accompanying the animals does not comply with the conditions set out in Article 17, - the equidae have been treated with substances prohibitedunder Community rules. 3. Without prejudice to any special conditions which may be adopted in accordance with the procedure laid down in Article 24, the competent authority of the Member State of destination may, on animal health grounds or where permission has not been given for animals refused entry pursuant to paragraph 1 to be sent back, designate the slaughterhouse to which such equidae must be taken. Article 21 1. Without prejudice to Article 13, if an infectious or contagious animal disease likely to endanger the health of livestock of one of the Member States breaks out or spreads in a third country or if any other reason connected with animal health justifies it, the Member State concerned shall prohibit the importation of animals of the species covered by this Directive, whether imported directly or indirectly through another Member State, from either the whole of the third country or part of its territory. 2. Measures taken by the Member States under paragraph 1, and notice of the withdrawal of such measures, must be communicated immediately to the other Member States and the Commission, together with the reasons therefor. The Standing Veterinary Committee shall meet as soon as possible after the communication referred to in the first subparagraph and shall decide, in accordance with the procedure laid down in Article 25, whether these measures should be amended, in particular in order to ensure their coordination with measures adopted by the other Member States, or withdrawn. If the situation referred to in paragraph 1 arises and if it appears necessary that other Member States should also apply the measures taken pursuant to that paragraph, amended where necessary in accordance with the preceding subparagraph, appropriate measures shall be adopted under the procedure laid down in Article 25. 3. Resumption of importation from the third country concerned shall be authorized in accordance with the same procedure. CHAPTER IV Final provisions Article 22 The provisions of this Directive, and in particular those contained in the second sentence of Article 4 (1) and in Articles 6, 8 and 21, shall be re-examined before 1 January 1993 in the framework of the proposals relating to the completion of the internal market, on which the Council will decide by a qualified majority. Article 23 The Annexes to this Directive shall be amended by the Commission in accordance with the procedure provided for in Article 25. Article 24 1. Where the procedure laid down in this Article is to be followed, the chairman shall refer the matter without delay to the Standing Veterinary Committee set up by Directive 68/361/EEC (6), hereinafter referred to as the '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. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. 4. 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 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 decided against the measures by a simple majority. Article 25 1. Where the procedure laid down in this Article is to be followed, the chairman shall refer the matter without delay to the 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 two days. 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. 4. 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 15 days 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 decided against the measures by a simple majority. Article 26 Article 34 of Directive 72/462/EEC shall apply to the requirements set out in Chapter III of this Directive. Article 27 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 1 January 1992. They shall forthwith inform the Commission thereof. Article 28 This Directive is addressed to the Member States.

31990L0428

1990

COUNCIL DIRECTIVE of 26 June 1990 on trade in equidae intended for competitions and laying down the conditions for participation therein (90/428/CEE) Having regard to the Treaty establishing the European Economic Community, and in particular Articles 42 and 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 equidae, being live animals, are included in the list of products in Annex II to the Treaty; Whereas in order to ensure the rational development of equidae production, thereby increasing productivity in the sector, rules governing intra-Community trade in equidae intended for competitions must be laid down at Community level; Whereas the breeding and rearing of equidae and in particular of horses is generally included in the farming sector; whereas it constitutes a source of income for part of the farming population; Whereas there are disparities in the Community as regards the rules for access to competitions; whereas those disparities constitute a barrier to intra-Community trade; Whereas trade in equidae intended for competitions and participation in such competitions may be jeopardized by disparities existing in the rules concerning the allocation of a percentage of the prize money or profits for the safeguard, development and improvement of breeding in the Member States; whereas introducing free access to the competitions presupposes harmonization of these rules; Whereas, pending such harmonization, in order, in particular, to maintain or increase productivity in that sector, Member States should be authorized to reserve a percentage of prize money or profits for the safeguard, development and improvement of their breeding activities; whereas, however, a ceiling should be fixed for that percentage; Whereas it is advisable to adopt implementing measures regarding certain technical aspects; whereas, for the purposes of the planned measures, provision should be made for close and effective cooperation between Member States and the Commission within the Standing Committee on Zootechnics, Article 1 This Directive lays down the conditions governing trade in equidae intended for competitions and the conditions governing their participation therein. Article 2 For the purposes of this Directive, the definitions set out in Article 2 of Council Directive 90/427/EEC of 26 June 1990 on the zootechnical and genealogical conditions governing intra-Community trade in equidae (4) shall apply. Furthermore, ‘competition’ means any equestrian competition, including horse racing, show-jumping, eventing, dressage, events reserved for horse-drawn vehicles and showing classes. Article 3 1. The rules of competitions may not discriminate between equidae which are registered in the Member State in which the competition is being held and equidae registered in another Member State. 2. The rules of competitions may not discriminate between equidae originating in the Member State in which the competition is being held and equidae originating in another Member State. Article 4 1. The obligations set out in Article 3 shall apply in particular to: (a) the requirements for entering the competition, in particular the minimum or maximum requirements; (b) the judging of the competition; (c) the prize money or profits which may accrue from the competition. 2. However, — the obligations referred to in Article 3 shall not affect the organization of: (a) competitions reserved for equidae registered in a specific studbook for the purpose of permitting the improvement of the breed; (b) regional competitions with a view to selecting equidae; (c) historic or traditional events. Member States intending to avail themselves of these possibilities shall inform the Commission thereof beforehand in general terms. — for each competition or type of competition Member States shall be authorized to reserve, through the bodies officially approved or recognized for that purpose, a certain percentage of the prize money or profits referred to in paragraph 1 (c) for the safeguard, development and improvement of breeding. The percentage may not exceed 30 % in 1991, 25 % in 1992 and 20 % from 1993. The criteria for the distribution of these funds in the Member State concerned shall be communicated to the Commission and the other Member States within the Standing Committee on Zootechnics. Before 31 December 1992 the Council shall re-examine the conditions for the application of these provisions on the basis of a Commission report that takes account of the progress made in harmonization in connection with all problems posed by the conditions for the breeding of competition horses, together with appropriate proposals on which the Council shall act by a qualified majority. 3. The general rules for the application of this Article shall be adopted in accordance with the procedure laid down in Article 6. Article 5 1. Until relevant decisions are adopted pursuant to Article 4 of Directive 90/427/EEC, the grounds on which an animal registered in a Member State is refused entry to a competition must be communicated in writing to the owner or his authorized representative. 2. In the circumstances described in paragraph 1, the owner or his authorized representative is entitled to obtain an expert opinion in accordance with the conditions laid down in Article 8 (2) of Directive 89/662/EE (5), which shall apply mutatis mutandis. 3. The Commission shall, in accordance with the procedure laid down in Article 6, adopt rules for the application of this Article. Article 6 Where the procedure laid down in this Article is to be used, the Standing Committee on Zootechnics, set up by Decision 77/505/EEC (6), shall act in accordance with the rules set out in Article 11 of Directive 88/661/EEC (7). Article 7 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1991. They shall forthwith inform the Commission thereof. Article 8 This Directive is addressed to the Member States.

31990L0394

1990

Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work (Sixth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) 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 following 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 Article 118a of the Treaty provides that the Council is to adopt, by means of Directives, minimum requirements in order to encourage improvements, especially in the working environment, so as to guarantee better protection of the health and safety of workers; Whereas, according to that Article, such directives must avoid imposing administrative, financial and legal constraint in a way which would hold back the creation and development of small and medium-sized undertakings; Whereas the Council resolution of 27 February 1984 on a second action programme of the European Communities on safety and health at work (4) provides for the development of protective measures for workers exposed to carcinogens; Whereas the Commission communication on its programme concerning safety, hygiene and health at work (5) provides for the adoption of Directives to guarantee the health and safety of workers; Whereas compliance with the minimum requirements designed to guarantee a better standard of health and safety as regards the protection of workers from the risks related to exposure to carcinogens at work is essential to ensure the health and safety of workers; 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 health and safety of workers at work (6); whereas therefore the provisions of that Directive are fully applicable to the exposure of workers to carcinogens, without prejudice to more stringent and/or specific provisions contained in this Directive; Whereas 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 (7), as last amended by Directive 88/490/EEC (8), contains a list of dangerous substances, together with particulars on the classification and labelling procedures in respect of each substance; Whereas 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 (9), as last amended by Directive 89/178/EEC (10), contains particulars on the classification and labelling procedures in respect of such preparations; Whereas the plan of action 1987 to 1989 adopted under the 'Europe against cancer' programme provides for support for European studies on the possible cancer risks of certain chemical substances; Whereas, although current scientific knowledge is not such that a level can be established below which risks to health cease to exist, a reduction in exposure to carcinogens will nonetheless reduce those risks; Whereas nevertheless, in order to contribute to a reduction in these risks, limit values and other directly related provisions should be established for all those carcinogens for which the available information, including scientific and technical data, make this possible; Whereas preventive measures must be taken for the protection of the health and safety of workers exposed to carcinogens; Whereas this Directive lays down particular requirements specific to exposure to carcinogens; Whereas this Directive constitutes a practical aspect of the realization of the social dimension of the internal market; Whereas, pursuant to Decision 74/325/EEC (11), as last amended by the 1985 Act of Accession, the Advisory Committee on Safety, Hygiene and Health Protection at Work is to be consulted by the Commission with a view to drawing up proposals in this field, SECTION I GENERAL PROVISIONS Article 1 Objective 1. This Directive, which is the sixth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC, has as its aim the protection of workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to carcinogens at work. It lays down particular minimum requirements in this area, including limit values. 2. This Directive shall not apply to workers exposed only to radiation covered by the Treaty establishing the European Atomic Energy Community. 3. Directive 89/391/EEC shall apply fully to the whole area referred to in paragraph 1, without prejudice to more stringent and/or specific provisions contained in this Directive. Article 2 Definition For the purposes of this Directive, 'carcinogen' means: (a) a substance to which, in Annex I to Directive 67/548/EEC, the risk-phrase R 45 'may cause cancer' is applied; (b) a preparation which, under Article 3 (5) (j) of Directive 88/379/EEC, must be labelled as R 45 'may cause cancer'; (c) a substance, a preparation or a process referred to in Annex I as well as a substance or preparation released by a process referred to in Annex I. Article 3 Scope - determination and assessment of risks 1. This Directive shall apply to activities in which workers are or are likely to be exposed to carcinogens as a result of their work. 2. In the case of any activity likely to involve a risk of exposure to carcinogens, the nature, degree and duration of workers' exposure must be determined in order to make it possible to assess any risk to the workers' health or safety and to lay down the measures to be taken. The assessment must be renewed regularly and in any event when any change occurs in the conditions which may affect workers' exposure to carcinogens. The employer must supply the authorities responsible at their request with the information used for making the assessment. 3. Furthermore, when assessing the risk, account shall be taken of all other cases of major exposure, such as those with harmful effects on the skin. 4. When the assessment referred to in paragraph 2 is carried out, employers shall give particular attention to any effects concerning the health or safety of workers at particular risk and shall, inter alia, take account of the desirability of not employing such workers in areas where they may come into contact with carcinogens. SECTION II EMPLOYERS' OBLIGATIONS Article 4 Reduction and replacement 1. The employer shall reduce the use of a carcinogen at the place of work, in particular by replacing it, in so far as is technically possible, by a substance, preparation or process which, under its conditions of use, is not dangerous or is less dangerous to workers' health or safety, as the case may be. 2. The employer shall, upon request, submit the findings of his investigations to the relevant authorities. Article 5 Prevention and reduction of exposure 1. Where the results of the assessment referred to in Article 3 (2) reveal a risk to workers' health or safety, workers' exposure must be prevented. 2. Where it is not technically possible to replace the carcinogen by a substance, preparation or process which, under its conditions of use, is not dangerous or is less dangerous to health or safety, the employer shall ensure that the carcinogen is, in so far as is technically possible, manufactured and used in a closed system. 3. Where a closed system is not technically possible, the employer shall ensure that the level of exposure of workers is reduced to as low a level as is technically possible. 4. Wherever a carcinogen is used, the employer shall apply all the following measures: (a) limitation of the quantities of a carcinogen at the place of work; (b) keeping as low as possible the number of workers exposed or likely to be exposed; (c) design of work processes and engineering control measures so as to avoid or minimize the release of carcinogens into the place of work; (d) evacuation of carcinogens at source, local extraction system or general ventilation, all such methods to be appropriate and compatible with the need to protect public health and the environment; (e) use of existing appropriate procedures for the measurement of carcinogens, in particular for the early detection of abnormal exposures resulting from an unforeseeable event or an accident; a) (f) application of suitable working procedures and methods; (g) collective protection measures and/or, where exposure cannot be avoided by other means, individual protection measures; (h) hygiene measures, in particular regular cleaning of floors, walls and other surfaces; (i) information for workers; (j) demarcation of risk areas and use of adequate warning and safety signs including 'no smoking' signs in areas where workers are exposed or likely to be exposed to carcinogens; (k) drawing up plans to deal with emergencies likely to result in abnormally high exposure; (l) means for safe storage, handling and transportation, in particular by using sealed and clearly and visibly labelled containers; (m) means for safe collection, storage and disposal of waste by workers, including the use of sealed and clearly and visibly labelled containers. Article 6 Information for the competent authority Where the results of the assessment referred to in Article 3 (2) reveal a risk to workers' health or safety, employers shall, when requested, make available to the competent authority appropriate information on: (a) the activities and/or industrial processes carried out, including the reasons for which carcinogens are used; (b) the quantities of substances or preparations manufactured or used which contain carcinogens; (c) the number of workers exposed; (d) the preventive measures taken; (e) the type of protective equipment used; (f) the nature and degree of exposure; (g) the cases of replacement. Article 7 Unforeseen exposure 1. In the event of an unforeseeable event or an accident which is likely to result in an abnormal exposure of workers, the employer shall inform the workers thereof. 2. Until the situation has been restored to normal and the causes of the abnormal exposure have been eliminated: (a) only those workers who are essential to the carrying out of repairs and other necessary work shall be permitted to work in the affected area; (b) the workers concerned shall be provided with protective clothing and individual respiratory protection equipment which they must wear; the exposure may not be permanent and shall be kept to the strict minimum of time necessary for each worker; (c) unprotected workers shall not be allowed to work in the affected area. Article 8 Foreseeable exposure 1. For certain activities such as maintenance, in respect of which it is foreseeable that there is the potential for a significant increase in exposure of workers, and in respect of which all scope for further technical preventive measures for limiting workers' exposure has already been exhausted, the employer shall determine, after consultation of the workers and/or their representatives in the undertaking or establishment, without prejudice to the employer's responsibility, the measures necessary to reduce the duration of workers' exposure to the minimum possible and to ensure protection of workers while they are engaged in such activities. Pursuant to the first subparagraph, the workers concerned shall be provided with protective clothing and individual respiratory protection equipment which they must wear as long as the abnormal exposure persists; that exposure may not be permanent and shall be kept to the strict minimum of time necessary for each worker. 2. Appropriate measures shall be taken to ensure that the areas in which the activities referred to in the first subparagraph of paragraph 1 take place are clearly demarcated and indicated or that unauthorized persons are prevented by other means from having access to such areas. Article 9 Access to risk areas Appropriate measures shall be taken by employers to ensure that access to areas in which the activities in respect of which the results of the assessment referred to in Article 3 (2) reveal a risk to workers' safety or health take place are accessible solely to workers who, by reason of their work or duties, are required to enter them. Article 10 Hygiene and individual protection 1. Employers shall be obliged, in the case of all activities for which there is a risk of contamination by carcinogens, to take appropriate measures to ensure that: (a) workers do not eat, drink or smoke in working areas where there is a risk of contamination by carcinogens; (b) workers are provided with appropriate protective clothing or other appropriate special clothing; separate storage places are provided for working or protective clothing and for street clothes; (c) workers are provided with appropriate and adequate washing and toilet facilities; (d) protective equipment is properly stored in a well-defined place; it is checked and cleaned if possible before, and in any case after, each use; defective equipment is repaired or replaced before further use. 2. Workers may not be charged for the cost of these measures. Article 11 Information and training of workers 1. Appropriate measures shall be taken by the employer to ensure that workers and/or workers' representatives in the undertaking or establishment receive sufficient and appropriate training, on the basis of all available information, in particular in the form of information and instructions, concerning: (a) potential risks to health, including the additional risks due to tobacco consumption; (b) precautions to be taken to prevent exposure; (c) hygiene requirements; (d) wearing and use of protective equipment and clothing; (e) steps to be taken by workers, including rescue workers, in the case of incidents and to prevent incidents. The training shall be: - adapted to take account of new or changed risk, and - repeated periodically if necessary. 2. Employers shall inform workers of installations and related containers containing carcinogens, ensure that all containers, packages and installations containing carcinogens are labelled clearly and legibly, and display clearly visible warning and hazard signs. Article 12 Information for workers Appropriate measures shall be taken to ensure that: (a) workers and/or any workers' representatives in the undertaking or establishment can check that this Directive is applied or can be involved in its application, in particular with regard to: i(i) the consequences for workers' safety and health of the selection, wearing and use of protective clothing and equipment, without prejudice to the employer's responsibility for determining the effectiveness of protective clothing and equipment; (ii) the measures determined by the employer which are referred to in the first subparagraph of Article 8 (1), without prejudice to the employer's responsibility for determining such measures; (b) workers and/or any workers' representatives in the undertaking or establishment are informed as quickly as possible of abnormal exposures, including those referred to in Article 8, of the causes thereof and of the measures taken or to be taken to rectify the situation; (c) the employer keeps an up-to-date list of the workers engaged in the activities in respect of which the results of the assessment referred to in Article 3 (2) reveal a risk to workers' health or safety, indicating, if the information is available, the exposure to which they have been subjected; (d) the doctor and/or the competent authority as well as all other persons who have responsibility for health and safety at work have access to the list referred to in subparagraph (c); (e) each worker has access to the information on the list which relates to him personally; (f) workers and/or any workers' representatives in the undertaking or establishment have access to anonymous collective information. Article 13 Consultation and participation of workers Consultation and participation of workers and/or their representatives in connection with matters covered by this Directive, including the Annexes hereto, shall take place in accordance with Article 11 of Directive 89/391/EEC. SECTION III MISCELLANEOUS PROVISIONS Article 14 Health surveillance 1. The Member States shall establish, in accordance with national laws and/or practice, arrangements for carrying out relevant health surveillance of workers for whom the results of the assessment referred to in Article 3 (2) reveal a risk to health or safety. 2. The arrangements referred to in paragraph 1 shall be such that each worker shall be able to undergo, if appropriate, relevant health surveillance: - prior to exposure, - at regular intervals thereafter. Those arrangements shall be such that it is directly possible to implement individual and occupational hygiene measures. 3. If a worker is found to be suffering from an abnormality which is suspected to be the result of exposure to carcinogens, the doctor or authority responsible for the health surveillance of workers may require other workers who have been similarly exposed to undergo health surveillance. In that event, a reassessment of the risk of exposure shall be carried out in accordance with Article 3 (2). 4. In cases where health surveillance is carried out, an individual medical record shall be kept and the doctor or authority responsible for health surveillance shall propose any protective or preventive measures to be taken in respect of any individual workers. 5. Information and advice must be given to workers regarding any health surveillance which they may undergo following the end of exposure. 6. In accordance with national laws and/or practice: - workers shall have access to the results of the health surveillance which concern them, and - the workers concerned or the employer may request a review of the results of the health surveillance. 7. Practical recommendations for the health surveillance of workers are given in Annex II. 8. All cases of cancer identified in accordance with national laws and/or practice as resulting from occupational exposure to a carcinogen shall be notified to the competent authority. Article 15 Record-keeping 1. The list referred to in Article 12 (c) and the medical record referred to in Article 14 (4) shall be kept for at least 40 years following the end of exposure, in accordance with national laws and/or practice. 2. Those documents shall be made available to the responsible authority in cases where the undertaking ceases activity, in accordance with national laws and/or practice. Article 16 Limit values 1. The Council shall, in accordance with the procedure laid down in Article 118a of the Treaty, set out limit values in Directives on the basis of the available information, including scientific and technical data, in respect of all those carcinogens for which this is possible, and, where necessary, other directly related provisions. 2. Limit values and other directly related provisions shall be set out in Annex III. Article 17 Annexes 1. Annexes I and III may be amended in accordance only with the procedure laid down in Article 118a of the Treaty. 2. Purely technical adjustments to Annex II in the light of technical progress, changes in international regulations or specifications and new findings in the field of carcinogens shall be adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC. Article 18 Use of data The Commission shall have access to the use made by the competent national authorities of the information referred to in Article 14 (8). Article 19 Final provisions 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. Should Directives 67/548/EEC or 88/379/EEC be amended by amending Directives after notification of this Directive with respect to the substances and preparations referred to in Article 2 (a) and (b), Member States shall bring into force the laws, regulations and administrative provisions necessary to introduce the amendments in question into the provisions referred to in the first subparagraph by the deadlines laid down for implementation of such amending Directives. Member States shall forthwith inform the Commission that the provisions referred to in this paragraph have been brought into force. 2. Member States shall communicate to the Commission the provisions of national law already adopted or which they adopt in the future in the field governed by this Directive. Article 20 This Directive is addressed to the Member States.

31990L0365

1990

Council Directive 90/365/EEC of 28 June 1990 on the right of residence for employees and self-employed persons who have ceased their occupational activity Having regard to the Treaty establishing the European Economic Community, and in particular Article 235 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 Article 3 (c) of the Treaty provides that the activities of the Community shall include, as provided in the Treaty, the abolition, as between Member States, of obstacles to freedom of movement for persons; Whereas Article 8a of the Treaty provides that the internal market must be established by 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, in accordance with the provisions of the Treaty; Whereas Articles 48 and 52 of the Treaty provide for freedom of movement for workers and self-employed persons, which entails the right of residence in the Member States in which they pursue their occupational activity; whereas it is desirable that this right of residence also be granted to persons who have ceased their occupational activity even if they have not exercised their right to freedom of movement during their working life; Whereas beneficiaries of the right of residence must not become an unreasonable burden on the public finances of the host Member State; Whereas under Article 10 of Regulation (EEC) No 1408/71 (4), as amended by Regulation (EEC) No 1390/81 (5), recipients of invalidity or old age cash benefits or pensions for accidents at work or occupational diseases are entitled to continue to receive these benefits and pensions even if they reside in the territory of a Member State other than that in which the institution responsible for payment is situated; Whereas this right can only be genuinely exercised if it is also granted to members of the family; Whereas the beneficiaries of this Directive should be covered by administrative arrangements similar to those laid down in particular by Directive 68/630/EEC (6) and Directive 64/221/EEC (7); Whereas the Treaty does not provide, for the action concerned, powers other than those of Article 235, Article 1 1. Member States shall grant the right of residence to nationals of Member States who have pursued an activity as an employee or self-employed person and to members of their families as defined in paragraph 2, provided that they are recipients of an invalidity or early retirement pension, or old age benefits, or of a pension in respect of an industrial accident or disease of an amount sufficient to avoid becoming a burden on the social security system of the host Member State during their period of residence and provided they are covered by sickness insurance in respect of all risks in the host Member State. The resources of the applicant shall be deemed sufficient where they are higher than the level of resources below which the host Member State may grant social assistance to its nationals, taking into account the personal circumstances of persons admitted pursuant to paragraph 2. Where the second subparagraph cannot be applied in a Member State, the resources of the applicant shall be deemed sufficient if they are higher than the level of the minimum social security pension paid by the host Member State. 2. The following shall, irrespective of their nationality, have the right to install themselves in another Member State with the holder of the right of residence: (a) his or her spouse and their descendants who are dependants; (b) dependent relatives in the ascending line of the holder of the right of residence and his or her spouse. Article 2 1. Exercise of the right of residence shall be evidenced by means of the issue of a document known as a 'Residence permit for a national of a Member State of the EEC', whose validity may be limited to five years on a renewable basis. However, the Member States may, when they deem it to be necessary, require revalidation of the permit at the end of the first two years of residence. Where a member of the family does not hold the nationality of a Member State, he or she shall be issued with a residence document of the same validity as that issued to the national on whom he or she depends. For the purposes of issuing the residence permit or document, the Member State may require only that the applicant present a valid identity card or passport and provide proof that he or she meets the conditions laid down in Article 1. 2. Articles 2, 3, 6 (1) (a) and (2) and Article 9 of Directive 68/360/EEC shall apply mutatis mutandis to the beneficiaries of this Directive. The spouse and the dependent children of a national of a Member State entitled to the right of residence within the territory of a Member State shall be entitled to take up any employed or self-employed activity anywhere within the territory of that Member State, even if they are not nationals of a Member State. Member States shall not derogate from the provisions of this Directive save on grounds of public policy, public security or public health. In that event, Directive 64/221/EEC shall apply. 3. This Directive shall not affect existing law on the acquisition of second homes. Article 3 The right of residence shall remain for as long as beneficiaries of that right fulfil the conditions laid down in Article 1. Article 4 The Commission shall, not more than three years after the date of implementation of this Directive, and at three-yearly intervals thereafter, draw up a report on the application of this Directive and submit it to the European Parliament and the Council. Article 5 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 June 1992. They shall forthwith inform the Commission thereof. Article 6 This Directive is addressed to the Member States.

31990L0364

1990

Council Directive 90/364/EEC of 28 June 1990 on the right of residence Having regard to the Treaty establishing the European Economic Community, and in particular Article 235 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 Article 3 (c) of the Treaty provides that the activities of the Community shall include, as provided in the Treaty, the abolition, as between Member States, of obstacles to freedom of movement for persons; Whereas Article 8a of the Treaty provides that the internal market must be established by 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 in accordance with the provisions of the Treaty; Whereas national provisions on the right of nationals of the Member States to reside in a Member State other than their own must be harmonized to ensure such freedom of movement; Whereas beneficiaries of the right of residence must not become an unreasonable burden on the public finances of the host Member State; Whereas this right can only be genuinely exercised if it is also granted to members of the family; Whereas the beneficiaries of this Directive should be covered by administrative arrangements similar to those laid down in particular in Directive 68/360/EEC (4) and Directive 64/221/EEC (5); Whereas the Treaty does not provide, for the action concerned, powers other than those of Article 235, Article 1 1. Member States shall grant the right of residence to nationals of Member States who do not enjoy this right under other provisions of Community law and to members of their families as defined in paragraph 2, provided that they themselves and the members of their families are covered by sickness insurance in respect of all risks in the host Member State and have sufficient resources to avoid becoming a burden on the social assistance system of the host Member State during their period of residence. The resources referred to in the first subparagraph shall be deemed sufficient where they are higher than the level of resources below which the host Member State may grant social assistance to its nationals, taking into account the personal circumstances of the applicant and, where appropriate, the personal circumstances of persons admitted pursuant to paragraph 2. Where the second subparagraph cannot be applied in a Member State, the resources of the applicant shall be deemed sufficient if they are higher than the level of the minimum social security pension paid by the host Member State. 2. The following shall, irrespective of their nationality, have the right to install themselves in another Member State with the holder of the right of residence: (a) his or her spouse and their descendants who are dependants; (b) dependent relatives in the ascending line of the holder of the right of residence and his or her spouse. Article 2 1. Exercise of the right of residence shall be evidenced by means of the issue of a document known as a 'Residence permit for a national of a Member State of the EEC', the validity of which may be limited to five years on a renewable basis. However, the Member States may, when they deem it to be necessary, require revalidation of the permit at the end of the first two years of residence. Where a member of the family does not hold the nationality of a Member State, he or she shall be issued with a residence document of the same validity as that issued to the national on whom he or she depends. For the purpose of issuing the residence permit or document, the Member State may require only that the applicant present a valid identity card or passport and provide proof that he or she meets the conditions laid down in Article 1. 2. Articles 2, 3, 6 (1) (a) and (2) and Article 9 of Directive 68/360/EEC shall apply mutatis mutandis to the beneficiaries of this Directive. The spouse and the dependent children of a national of a Member State entitled to the right of residence within the territory of a Member State shall be entitled to take up any employed or self-employed activity anywhere within the territory of that Member State, even if they are not nationals of a Member State. Member States shall not derogate from the provisions of this Directive save on grounds of public policy, public security or public health. In that event, Directive 64/221/EEC shall apply. 3. This Directive shall not affect existing law on the acquisition of second homes. Article 3 The right of residence shall remain for as long as beneficiaries of that right fulfil the conditions laid down in Article 1. Article 4 The Commission shall, not more than three years after the date of implementation of this Directive, and at three-yearly intervals thereafter, draw up a report on the application of this Directive and submit it to the European Parliament and the Council. Article 5 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 June 1992. They shall forthwith inform the Commission thereof. Article 6 This Directive is addressed to the Member States.

31990L0387

1990

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 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 8 a of the Treaty stipulates that the internal market shall comprise an area without internal frontiers in which the free movement of services is ensured, in accordance with the provisions of the Treaty; Whereas the Commission submitted a Green Paper on the development of the common market for telecommunications services and equipment, dated 30 June 1987, and a communication on the implementation of that Green Paper up to 1992, dated 9 February 1988; Whereas the Council adopted on 30 June 1988 a resolution on the development of the common market for telecommunications services and equipment up to 1992 (4); Whereas the full establishment of a Community-wide market in telecommunications services will be promoted by the rapid introduction of harmonized principles and conditions for open network provision; Whereas, since situations differ and technical and administrative constraints exist in the Member States, this objective should be realized in stages; Whereas the conditions of open network provision must be consistent with certain principles and must not restrict access to networks and services except for reasons of general public interest, hereinafter referred to as 'essential requirements'; Whereas the definition and application of such principles and essential requirements must take full account of the fact that any restrictions of the right to provide services within and between Member States must be objectively justified, must follow the principle of proportionality and must not be excessive in relation to the aim pursued; Whereas the conditions of open network provision must not allow for any additional restrictions on the use of the public telecommunications network and/or public telecommunications services except those restrictions which may be derived from the exercise of special or exclusive rights granted by Member States and which are compatible with Community law; Whereas tariff principles should be clearly laid down to ensure fair and transparent conditions for all users; Whereas this entire Directive must be read in the light of Annex III which lays down a work programme for the first three years; Whereas the establishment of harmonized conditions of open network provision must be a progressive process and must be prepared with the assistance of a committee composed of representatives of the Member States, which consults the representatives of the telecommunications organizations, the users, the consumers, the manufacturers and the service providers; whereas this process must also be open to all parties concerned and therefore sufficient time must be given for public comment; Whereas 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; Whereas work to be undertaken in this area must take full account, inter alia, of the framework resulting from the provisions of Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (5), as last amended by Directive 88/182/EEC (6), Council Directive 86/361/EEC of 24 July 1986 on the initial stage of the mutual recognition of type approval for telecommunications terminal equipment (7) and Council Decision 87/95/EEC of 22 December 1986 on standardization in the field of information technology and telecommunications (8); Whereas the formal adoption on 12 February 1988 of the statutes of the European Telecommunications Standards Institute (ETSI) and of the associated internal rules has created a new mechanism for producing European telecommunications standards; Whereas the Council in its resolution of 27 April 1989 on standardization in the field of information technology and telecommunications (9) supported the work of ETSI and invited the Commission to contribute to the coherent development of ETSI and lend it its support; Whereas the Community-wide definition and implementation of harmonized network termination points establishing the physical interface between the network infrastructure and users' and other service providers' equipment will be an essential element of the overall concept of open network provision; Whereas Commission Directive 88/301/EEC of 16 May 1988 on competition in the markets in telecommunications terminal equipment (10) requires Member States to ensure that users who so request are given access to network termination points within a reasonable time period; Whereas one of the principal aims of the establishment of an internal market in telecommunications services must be the creation of conditions to promote the development of Europe-wide services; Whereas, in its abovementioned resolution of 30 June 1988, the Council considered the taking fully into account of the external aspects of Community measures on telecommunications to be a major policy goal; Whereas the Community attaches very great importance to the continued growth of cross-border telecommunications services, to the contribution that telecommunications services provided by companies, firms or natural persons established in a Member State may make to the growth of the Community market, and to the increased participation of Community service providers in third country markets; whereas it will therefore be necessary, as specific Directives are drawn up, to ensure that these objectives are taken into account with a view to reaching a situation where the progressive realization of the internal market for telecommunications services will, where appropriate, be accompanied by reciprocal market opening in other countries; Whereas this result should be achieved preferably through multilateral negotiations in the framework of GATT, it being understood that bilateral discussions between the Community and third countries may also contribute to this process; Whereas this Directive should not address the problems of mass media, meaning problems linked to broadcasting and distribution of television programmes via telecommunications means, in particular cable television networks, which need special consideration; Whereas neither should this Directive address the question of communication via satellite for which, according to the abovementioned Council resolution of 30 June 1988, a common position should be worked out; Whereas the Council, on the basis of a report which the Commission is to submit to the European Parliament and the Council, and in accordance with Article 100b of the Treaty, will review, during 1992, any remaining conditions for access to telecommunications services which have not been harmonized, the effects of these conditions on the workings of the internal market for telecommunications services, and the extent to which this market needs to be further opened up, Article 1 1. This Directive concerns the harmonization of conditions for open and efficient access to and use of public telecommunications networks and, where applicable, public telecommunications services. 2. The conditions referred to in paragraph 1 are designed to facilitate the provision of services using public telecommunications networks and/or public telecommunications services, within 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. Article 2 For the purposes of this Directive: 1. 'telecommunications organizations' means public or private bodies, to which a Member State grants special or exclusive rights for the provision of a public telecommunications network and, where applicable, public telecommunications services. For the requirements of this Directive, Member States shall notify the Commission of the bodies to which they have granted special or exclusive rights; 2. 'special or exclusive rights' means the rights granted by a Member State or a public authority to one or more public or private bodies through any legal, regulatory or administrative instrument reserving them the right to provide a service or undertake an activity; 3. 'public telecommunications network' means the public telecommunications infrastructure which permits the conveyance of signals between defined network termination points by wire, by microwave, by optical means or by other electromagnetic means; 4. - 'telecommunications services' means services whose provision consists wholly or partly in the transmission and routing of signals on a telecommunications network by means of telecommunications processes, with the exception of radio broadcasting and television; - 'public telecommunications services' means telecommunications services whose supply Member States have specifically entrusted inter alia to one or more telecommunications organizations; 5. 'network termination point' means all physical connections and their technical access specifications which form part of the public telecommunications network and are necessary for access to and efficient communication through that public network; 6. 'essential requirements' means the non-economic reasons in the general interest which may cause a Member State to restrict access to the public telecommunications network or public telecommunications services. These reasons are security of network operations, maintenance of network integrity and, in justified cases, interoperability of services and data protection. Data protection may include protection of personal data, the confidentiality of information transmitted or stored as well as the protection of privacy; 7. 'voice telephony' means the commercial provision for the public or direct transport of real-time speech via the public switches network or networks such that any user can use equipment connected to a network termination point to communicate with another user of equipment connected to another termination point; 8. 'telex service' means the commercial provision for the public of direct transport of telex messages in accordance with the relevant 'Comité consultatif international télégraphique et téléphonique' (CCITT) recommendation via the public switched network or networks, whereby any user can use equipment connected to a network termination point to communicate with another user using another termination point; 9. 'packet- and circuit-switched data services' means the commercial provision for the public of direct transport of data via the public switched network or networks such that any equipment connected to a network termination point can communicate with equipment connected to another termination point; 10. 'open network provision conditions' means the conditions, harmonized according to the provisions of this Directive, which concern the open and efficient access to public telecommunications networks and, where applicable, public telecommunications services and the efficient use of those networks and services. Without prejudice to their application on a case-by-case basis, the open network provision conditions may include harmonized conditions with regard to: - technical interfaces, including the definition and implementation of network termination points, where required, - usage conditions, including access to frequencies where required, - tariff principles; 11. 'technical specifications', 'standards' and 'terminal equipment' are given the same meaning for those terms as in Article 2 of Directive 86/361/EEC. Article 3 1. Open network provision conditions must comply with a number of basic principles set out hereafter, namely that: - they must be based on objective criteria, - they must be transparent and published in an appropriate manner, - they must guarantee equality of access and must be non-discriminatory, in accordance with Community law. 2. Open network provision conditions must not restrict access to public telecommunications networks or public telecommunications services, except for reasons based on essential requirements, within the framework of Community law, namely: - security of network operations, - maintenance of network integrity, - interoperability of services, in justified cases, - protection of data, as appropriate. In addition, the conditions generally applicable to the connection of terminal equipment to the network shall apply. 3. Open network provision conditions may not allow for any additional restrictions on the use of the public telecommunications networks and/or public telecommunications services except the restrictions which may be derived from the exercise of special or exclusive rights granted by Member States and which are compatible with Community law. 4. The Council, acting in accordance with Article 100a of the Treaty, may, if necessary, modify the points set out in paragraphs 1 and 2. 5. Without prejudice to the specific Directives provided for in Article 6 and in so far as the application of the essential requirements referred to in paragraph 2 of this Article may cause a Member State to limit access to one of its public telecommunications networks or services, the rules for uniform application of the essential requirements, in particular concerning the interoperability of services and the protection of data, shall be determined, where appropriate, by the Commission, in accordance with the procedure laid down in Article 10. Article 4 1. Open network provision conditions shall be defined in stages under the procedure set out hereafter. 2. Open network provision conditions shall concern the areas selected in accordance with the list in Annex I. The Council, acting in accordance with Article 100a of the Treaty, may, if necessary, modify this list. 3. Using the list referred to in paragraph 2, the Commission shall draw up a work programme each year, under the procedure laid down in Article 9. 4. For the work programme referred to in paragraph 3, the Commission shall: (a) initiate detailed analysis, in consultation with the committee referred to in Article 9, and draw up reports on the results of this analysis; (b) invite, by publication of a notice to that effect in the Official Journal of the European Communities, public comment by all parties concerned on the reports on the detailed analysis provided for in subparagraph (a). The period for submitting such comment shall be not less than three months from the date of publication of the said notice; (c) request, where appropriate, the European Telecommunications Standards Institute (ETSI) to draw up European standards, taking account of international standardization as a basis for setting up, where required, within specified time limits, harmonized technical interfaces and/or service features. In so doing, ETSI shall coordinate, in particular, with the Joint European Standards Institution CEN/Cenelec; (d) draw up proposals for open network provision conditions in accordance with Article 3 and with the open network provision reference framework described in Annex II. 5. For 1990, 1991 and 1992 a work programme shall be drawn up in order to implement the guidelines in Annex III. Article 5 1. Reference to European standards drawn up as a basis for harmonized technical interfaces and/or service features for open network provision according to Article 4 (4) (c) shall be published in the Official Journal of the European Communities as suitable for open network provision. 2. The standards mentioned under paragraph 1 shall carry with them the presumption: (a) that a service provider who complies with those standards fulfils the relevant essential requirements, and (b) that a telecommunications organization which complies with those standards fulfils the requirement of open and efficient access. 3. If the implementation of European standards within the meaning of Article 5 (2) appears inadequate to ensure the interoperability of transfrontier services in one or more Member States, reference to European standards may be made compulsory under the procedure laid down in Article 10, to the extent strictly necessary to ensure such interoperability and to improve freedom of choice for users. The procedure provided for in this paragraph may in no way affect the implementation of Articles 85 and 86 of the Treaty. 4. Where a Member State or the Commission considers that the harmonized standards mentioned under paragraph 1 do not correspond to the objective of open and efficient access, in particular the basic principles and the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the committee referred to in Article 9, giving the reasons therefore. The committee shall deliver an opinion without delay. 5. In the light of the committee's opinion and after consultation of the standing committee set up by Directive 83/189/EEC, the Commission shall inform the Member States whether or not it is necessary to withdraw references to those standards from the Official Journal of the European Communities. Article 6 Following the completion of the procedures set out in Articles 4 and 5, and acting in accordance with Article 100a of the Treaty, the Council shall adopt specific Directives establishing open network provision conditions including a time schedule for implementing them. Article 7 The Council, acting in accordance with Article 100a of the Treaty, taking Article 8c of the Treaty into consideration, shall, where required, adopt measures for harmonizing declaration and/or licensing procedures for the provision of services via public telecommunications networks, with a view to establishing conditions in which there would be mutual recognition of declaration and/or licensing procedures. Article 8 During 1992 the Council, on the basis of a report which the Commission shall submit to the European Parliament and the Council, shall review progess on harmonization and any restrictions on access to telecommunications networks and services still remaining, the effects of those restrictions on the operation of the internal telecommunications market, and measures which could be taken to remove those restrictions, in conformity with Community law, taking account of technological development and in accordance with the procedure provided for under Article 100b of the Treaty. Article 9 1. The Commission shall be assisted by a committee of a advisory nature composed of the representatives of the Member States and chaired by the representative of the Commission. The committee shall, in particular, consult the representatives of the telecommunications organizations, the users, the consumers, the manufacturers and the service providers. It shall lay down its rules of procedure. 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 10 1. Notwithstanding the provisions of Article 9, the following procedure shall apply in respect of the matters covered by Article 3 (5) and Article 5 (3). 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. 4. 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 11 1. Member States shall bring into force the laws, regulations and administrative provisions necessary in order to comply with this Directive before 1 January 1991 at the latest. They shall forthwith inform the Commission thereof. 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 12 This Directive is addressed to the Member States.

31990L0388

1990

Commission Directive 90/388/EEC of 28 June 1990 on competition in the markets for telecommunications services Having regard to the Treaty establishing the European Economic Community, and in particular Article 90 (3) thereof, Whereas: (1) The improvement of telecommunications in the Community is an essential condition for the harmonious development of economic activities and a competitive market in the Community, from the point of view of both service providers and users. The Commission has therefore adopted a programme, set out in its Green Paper on the development of the common market for telecommunications services and equipment and in its communication on the implementation of the Green Paper by 1992, for progressively introducing competition into the telecommunications market. The programme does not concern mobile telephony and paging services, and mass communication services such as radio for television. The Council, in its resolution of 30 June 1988 (1), expressed broad support for the objectives of this programme, and in particular the progressive creation of an open Community market for telecommunications services. The last decades have seen considerable technological advances in the telecommunications sector. These allow an increasingly varied range of services to be provided, notably data transmission services, and also make it technically and economically possible for competition to take place between different service providers. (2) In all the Member States the provision and operation of telecommunications networks and the provision of related services are generally vested in one or more telecommunications organizations holding exclusive or special rights. Such rights are characterized by the discretionary powers which the State exercises in various degrees with regard to access to the market for telecommunications services. (3) The organizations entrusted with the provision and operation of the telecommunications network are undertakings within the meaning of Article 90 (1) of the Treaty because they carry on an organized business activity, namely the provision of telecommunications services. They are either public untertakings or private enterprises to which the State has granted exclusive or special rights. (4) Several Member States, while ensuring the performance of public service tasks, have already revised the system of exclusive or special rights that used to exist in the telecommunications sector in their country. In all cases, the system of exclusive or special rights has been maintained in respect of the provision and operation of the network. In some Member States, it has been maintained for all telecommunications services, while in others such rights cover only certain services. All Member States have either themselves imposed or allowed their telecommunications administrations to impose restrictions on the free provision of telecommunications services. (5) The granting of special or exclusive rights to one or more undertakings to operate the network derives from the discretionary power of the State. The granting by a Member State of such rights inevitably restricts the provision of such services by other undertakings to or from other Member States. (6) In practice, restrictions on the provision of telecommunications services within the meaning of Article 59 to or from other Member States consist mainly in the prohibition on connecting leased lines by means of concentrators, multiplexers and other equipment to the switched telephone network, in imposing access charges for the connection that are out of proportion to the service provided, in prohibiting the routing of signals to or from third parties by means of leased lines or applying volume sensitive tariffs without economic justification or refusing to give service providers access to the network. The effect of the usage restrictions and the excessive charges in relation to net cost is to hinder the provision to or from other Member States of such telecommunications services as: - services designed to improve telecommunications functions, e.g. conversion of the protocol, code, format or speed, - information services providing access to data bases, - remote data-processing services, - message storing and forwarding services, e.g. electronic mail, - transaction services, e.g. financial transactions, electronic commercial data transfer, teleshopping and telereservations, - teleaction services, e.g. telemetry and remote monitoring. (7) Articles 55, 56 and 66 of the Treaty allow exceptions on non-economic grounds to the freedom to provide services. The restrictions permitted are those connected, even occasionally, with the exercise of official authority, and those connected with public policy, public security or public health. Since these are exceptions, they must be interpreted restrictively. None of the telecommunications services is connected with the exercise of official authority involving the right to use undue powers compared with the ordinary law, privileges of public power or a power of coercion over the public. The supply of telecommunication services cannot in itself threaten public policy and cannot affect public health. (8) The Court of Justice caselaw also recognizes restrictions on the freedom to provide services if they fulfil essential requirements in the general interest and are applied without discrimination and in proportion to the objective. Consumer protection does not make it necessary to restrict freedom to provide telecommunications services since this objective can also be attained through free competition. Nor can the protection of intellectual property be invoked in this connection. The only essential requirements derogating from Article 59 which could justify restrictions on the use of the public network are the maintenance of the integrity of the network, security of network operations and in justified cases, interoperability and data protection. The restrictions imposed, however, must be adapted to the objectives pursued by these legitimate requirements. Member States will have to make such restrictions known to the public and notify them to the Commission to enable it to assess their proportionality. (9) In this context, the security of network operations means ensuring the availability of the public network in case of emergency. The technical integrity of the public network means ensuring its normal operation and the interconnection of public networks in the Community on the basis of common technical specifications. The concept of interoperability of services means complying with such technical specifications introduced to increase the provision of services and the choice available to users. Data protection means measures taken to warrant the confidentiality of communications and the protection of personal data. (10) Apart from the essential requirements which can be included as conditions in the licensing or declaration procedures, Member States can include conditions regarding public-service requirements which constitute objective, non-discriminatory and transparent trade regulations regarding the conditions of permanence, availability and quality of the service. (11) When a Member State has entrusted a telecommunications organization with the task of providing packet or circuit switched data services for the public in general and when this service may be obstructed because of competition by private providers, the Commission can allow the Member State to impose additional conditions for the provision of such a service, with respect also to geographical coverage. In assessing these measures, the Commission in the context of the achievement of the fundamental objectives of the Treaty referred to in Article 2 thereof, including that of strengthening the Community's economic and social cohesion as referred to in Article 130a, will also take into account the situation of those Member States in which the network for the provision of the packet or circuit switched services is not yet sufficiently developed and which could justifiy the deferment for these Member States until 1 January 1996 of the date for prohibition on the simple resale of leased line capacity. (12) Article 59 of the Treaty requires the abolition of any other restriction on the freedom of nationals of Member States who are established in a Community country to provide services to persons in other Member States. The maintenance or introduction of any exclusive or special right which does not correspond to the abovementioned criteria is therefore a breach of Article 90 in conjunction with Article 59. (13) Article 86 of the Treaty prohibits as incompatible with the common market any conduct by one or more undertakings that involves an abuse of a dominant position within the common market or a substantial part of it. Telecommunications organizations are also undertakings for the purposes of this Article because they carry out economic activities, in particular the service they provide by making telecommunications networks and services available to users. This provision of the network constitutes a separate services market as it is not interchangeable with other services. On each national market the competitive environment in which the network and the telecommunications services are provided is homogeneous enough for the Commission to be able to evaluate the power held by the organizations providing the services on these territories. The territories of the Member States constitute distinct geographical markets. This is essentially due to the existing difference between the rules governing conditions of access and technical operation, relating to the provision of the network and of such services. Furthermore, each Member State market forms a substantial part of the common market. (14) In each national market the telecommunications organizations hold individually or collectively a dominant position for the creation and the exploitation of the network because they are the only ones with networks in each Member State covering the whole territory of those States and because their governments granted them the exclusive right to provide this network either alone or in conjunction with other organizations. (15) Where a State grants special or exclusive rights to provide telecommunications services to organizations which already have a dominant position in creating and operating the network, the effect of such rights is to strengthen the dominant position by extending it to services. (16) Moreover, the special or exclusive rights granted to telecommunications organizations by the State to provide certain telecommunications services mean such organizations: (a) prevent or restrict access to the market for these telecommunications services by their competitors, thus limiting consumer choice, which is liable to restrict technological progress to the detriment of consumers; (b) compel network users to use the services subject to exclusive rights, and thus make the conclusion of network utilization contracts dependent on acceptance of supplementary services having no connection with the subject of such contracts. Each of these types of conduct represents a specific abuse of a dominant position which is likely to have an appreciable effect on trade between Member States, as all the services in question could in principle be supplied by providers from other Member States. The structure of competition within the common market is substantially changed by them. At all events, the special or exclusive rights for these services give rise to a situation which is contrary to the objective in Article 3 (f) of the Treaty, which provides for the institution of a system ensuring that competition in the common market is not distorted, and requires a fortiori that competition must not be eliminated. Member States have an obligation under Article 5 of the Treaty to abstain from any measure which could jeopardize the attainment of the objectives of the Treaty, including that of Article 3 (f). (17) The exclusive rights to telecommunications services granted to public undertakings or undertakings to which Member States have granted special or exclusive rights for the provision of the network are incompatible with Article 90 (1) in conjunction with Article 86. (18) Article 90 (2) of the Treaty allows derogation from the application of Articles 59 and 86 of the Treaty where such application would obstruct the performance, in law or in fact, of the particular task assigned to the telecommunications organizations. This task consists in the provision and exploitation of a universal network, i.e. one having general geographical coverage, and being provided to any service provider or user upon request within a reasonable period of time. The financial resources for the development of the network still derive mainly from the operation of the telephone service. Consequently, the opening-up of voice telephony to competition could threaten the financial stability of the telecommunications organizations. The voice telephony service, whether provided from the present telephone network or forming part of the ISDN service, is currently also the most important means of notifying and calling up emergency services in charge of public safety. (19) The provision of leased lines forms an essential part of the telecommunications organizations' tasks. There is at present, in almost all Member States, a substantial difference between charges for use of the data transmission service on the switched network and for use of leased lines. Balancing those tariffs without delay could jeopardize this task. Equilibrium in such charges must be achieved gradually between now and 31 December 1992. In the meantime it must be possible to require private operators not to offer to the public a service consisting merely of the resale of leased line capacity, i.e. including only such processing, switching of data, storing, or protocol conversion as is necessary for transmission in real time. The Member States may therefore establish a declaration system through which private operators would undertake not to engage in simple resale. However, no other requirement may be imposed on such operators to ensure compliance with this measure. (20) These restrictions do not affect the development of trade to such an extent as would be contrary to the interests of the Community. Under these circumstances, these restrictions are compatible with Article 90 (2) of the Treaty. This may also be the case as regards the measures adopted by Member States to ensure that the activities of private service providers do not obstruct the public switched-data service. (21) The rules of the Treaty, including those on competition, apply to telex services; however, the use of this service is gradually declining throughout the Community owing to the emergence of competing means of telecommunication such as telefax. The abolition of current restrictions on the use of the switched telephone network and leased lines will allow telex messages to be retransmitted. In view of this particular trend, an individual approach is necessary. Consequently, this Directive should not apply to telex services. (22) The Commission will in any event reconsider in the course of 1992 the remaining special or exclusive rights on the provision of services taking account of technological development and the evolution towards a digital infrastructure. (23) Member States may draw up fair procedures for ensuring compliance with the essential requirements without prejudice to the harmonization of the latter at Community level within the framework of the Council Directives on open network provision (ONP). As regards data-switching, Member States must be able, as part of such procedures, to require compliance with trade regulations from the standpoint of conditions of permanence, availability and quality of the service, and to include measures to safeguard the task of general economic interest which they have entrusted to a telecommunications organization. The procedures must be based on specific objective criteria and be applied without discrimination. The criteria should in particular be justified and proportional to the general interest objective, and be duly motivated and published. The Commission must be able to examine them in depth in the light of the rules on free competition and freedom to provide services. In any event, Member States that have not notified the Commission of their planned licensing criteria and procedures within a given time may no longer impose any restrictions on the freedom to provide data transmission services to the public. (24) Member States should be given more time to draw up general rules on the conditions governing the provision of packet- or circuit-switched data services for the public. (25) Telecommunications services should not be subject to any restriction, either as regards free access by users to the services, or as regards the processing of data which may be carried out before messages are transmitted through the network or after messages have been received, except where this is warranted by an essential requirement in proportion to the objective pursued. (26) The digitization of the network and the technological improvement of the terminal equipment connected to it have brought about an increase in the number of functions previously carried out within the network and which can now be carried out by users themselves with increasingly sophisticated terminal equipment. It is necessary to ensure that suppliers of telecommunication services, and notably suppliers of telephone and packet or circuit-switched data transmission services enable operators to use these functions. (27) Pending the establishing of Community standards with a view to an open network provision (ONP), the technical interfaces currently in use in the Member States should be made publicly available so that firms wishing to enter the markets for the services in question can take the necessary steps to adapt their services to the technical characteristics of the networks. If the Member States have not yet established such technical interfaces, they should do so as quickly as possible. All such draft measures should be communicated to the Commission in accordance with Council Directive 83/189/EEC (2), as last amended by Directive 88/182/EEC (3). (28) Under national legislation, telecommunications organizations are generally given the function of regulating telecommunications services, particularly as regards licensing, control of type-approval and mandatory interface specifications, frequency allocation and monitoring of conditions of use. In some cases, the legislation lays down only general principles governing the operation of the licensed services and leaves it to the telecommunications organizations to determine the specific operating conditions. (29) This dual regulatory and commercial function of the telecommunications organizations has a direct impact on firms offering telecommunications services in competition with the organizations in question. By this bundling of activities, the organizations determine or, at the very least, substantially influence the supply of services offered by their competitors. The delegation to an undertaking which has a dominant position for the provision and exploitation of the network, of the power to regulate access to the market for telecommunication services constitutes a strengthening of that dominant position. Because of the conflict of interests, this is likely to restrict competitors' access to the markets in telecommunications services and to limit users' freedom of choice. Such arrangements may also limit the outlets for equipment for handling telecommunications messages and, consequently, technological progress in that field. This combination of activities therefore constitutes an abuse of the dominant position of telecommunications organizations within the meaning of Article 86. If it is the result of a State measure, the measure is also incompatible with Article 90 (1) in conjunction with Article 86. (30) To enable the Commission to carry out effectively the monitoring task assigned to it by Article 90 (3), it must have available certain essential information. That information must in particular give the Commission a clear view of the measures of Member States, so that it can ensure that access to the network and the various related services are provided by each telecommunications organization to all its customers on non-discriminatory tariff and other terms. Such information should cover: - measures taken to withdraw exclusive rights pursuant to this Directive, - the conditions on which licences to provide telecommunications services are granted. The Commission must have such information to enable it to check, in particular, that all the users of the network and services, including telecommunications organizations where they are providers of services, are treated equally and fairly. (31) The holders of special or exclusive rights to provide telecommunications services that will in future be open to competition have been able in the past to impose long-term contracts on their customers. Such contracts would in practice limit the ability of any new competitors to offer their services to such customers and of such customers to benefit from such services. Users must therefore be given the right to terminate their contracts within a reasonable length of time. (32) Each Member State at present regulates the supply of telecommunications services according to its own concepts. Even the definition of certain services differs from one Member State to another. Such differences cause distortions of competition likely to make the provision of cross-frontier telecommunications services more difficult for economic operators. This is why the Council, in its resolution of 30 June 1988, considered that one of the objectives of a telecommunications policy was the creation of an open Community market for telecommunications services, in particular through the rapid definition, in the form of Council Directives, of technical conditions, conditions of use and principles governing charges for an open network provision (ONP). The Commission has presented a proposal to this end to the Council. Harmonization of the conditions of access is not however the most appropriate means of removing the barriers to trade resulting from infringements of the Treaty. The Commission has a duty to ensure that the provisions of the Treaty are applied effectively and comprehensively. (33) Article 90 (3) assigns clearly-defined duties and powers to the Commission to monitor relations between Member States and their public undertakings and undertakings to which they have granted special or exclusive rights, particularly as regards the removal of obstacles to freedom to provide services, discrimination between nationals of the Member States and competition. A comprehensive approach is necessary in order to end the infringements that persist in certain Member States and to give clear guidelines to those Member States that are reviewing their legislation so as to avoid further infringements. A Directive within the meaning of Article 90 (3) of the Treaty is therefore the most appropriate means of achieving that end, Article 1 1. For the purposes of this Directive: - 'telecommunication organizations' means public or private bodies, and the subsidiaries they control, to which a Member State grants special or exclusive rights for the provision of a public telecommunications network and, when applicable, telecommunications services, - 'special or exclusive rights' means the rights granted by a Member State or a public authority to one or more public or private bodies through any legal, regulatory or administrative instrument reserving them the right to provide a service or undertake an activity, - 'public telecommunications network' means the public telecommunications infrastructure which permits the conveyance of signals between defined network termination points by wire, by microwave, by optical means or by other electromagnetic means, - 'telecommunications services' means services whose provision 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, - 'network termination point' means all physical connections and their technical access specifications which form part of the public telecommunications network and are necessary for access to and efficient communication through that public network, - 'essential requirements' means the non-economic reasons in the general interest which may cause a Member State to restrict access to the public telecommunications network or public telecommunications services. These reasons are security of network operations, maintenance of network integrity, and, in justified cases, interoperability of services and data protection. Data protection may include protection of personal data, the confidentiality of information transmitted or stored as well as the protection of privacy, - 'voice telephony' means 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, - 'telex service' means the commercial provision for the public of direct transmission of telex messages in accordance with the relevant Comité consultatif international télégraphique et téléphonique (CCITT) recommendation 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, - 'packet- and circuit-switched data services' means the commercial provision for the public of direct transport of data 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, - '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. 2. This Directive shall not apply to telex, mobile radiotelephony, paging and satellite services. Article 2 Without prejudice to Article 1 (2), Member States shall withdraw all special or exclusive rights for the supply of telecommunications services other than voice telephony and shall take the measures necessary to ensure that any operator is entitled to supply such telecommunications services. Member States which make the supply of such services subject to a licensing or declaration procedure aimed at compliance with the essential requirements shall ensure that the conditions for the grant of licences are objective, non-discriminatory and transparent, that reasons are given for any refusal, and that there is a procedure for appealing against any such refusal. Without prejudice to Article 3, Member States shall inform the Commission no later than 31 December 1990 of the measures taken to comply with this Article and shall inform it of any existing regulations or of plans to introduce new licensing procedures or to change existing procedures. Article 3 As regards packet- or circuit-switched data services, Member States may, until 31 December 1992, under the authorization procedures referred to in Article 2, prohibit economic operators from offering leased line capacity for simple resale to the public. Member States shall, no later than 30 June 1992, notify to the Commission at the planning stage any licensing or declaration procedure for the provision of packet- or circuit-switched data services for the public which are aimed at compliance with: - essential requirements, or - trade regulations relating to conditions of permanence, availability and quality of the service, or - measures to safeguard the task of general economic interest which they have entrusted to a telecommunications organization for the provision of switched data services, if the performance of that task is likely to be obstructed by the activities of private service providers. The whole of these conditions shall form a set of public-service specifications and shall be objective, non-discriminatory and transparent. Member States shall ensure, no later than 31 December 1992, that such licensing or declaration procedures for the provision of such services are published. Before they are implemented, the Commission shall verify the compatibility of these projects with the Treaty. Article 4 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 the networks objective and non-discriminatory and publish them. In particular, they shall ensure that operators who so request can obtain leased lines within a reasonable period, that there are no restrictions on their use other than those justified in accordance with Article 2. Member States shall inform the Commission no later than 31 December 1990 of the steps they have taken to comply with this Article. Each time the charges for leased lines are increased, Member States shall provide information to the Commission on the factors justifying such increases. Article 5 Without prejudice to the relevant international agreements, Member States shall ensure that the characteristics of the technical interfaces necessary for the use of public networks are published by 31 December 1990 at the latest. Member States shall communicate to the Commission, in accordance with Directive 83/189/EEC, any draft measure drawn up for this purpose. Article 6 Member States shall, as regards the provision of telecommunications services, and existing restrictions on the processing of signals before their transmission via the public network or after their reception, unless the necessity of these restrictions for compliance with public policy or essential requirements is demonstrated. Without prejudice to harmonized Community rules adopted by the Council on the provision of an open network, Member States shall ensure as regards services providers including the telecommunications organizations that there is no discrimination either in the conditions of use or in the charges payable. Member States shall inform the Commission of the measures taken or draft measures introduced in order to comply with this Article by 31 December 1990 at the latest. Article 7 Member States shall ensure that from 1 July 1991 the grant of operating licences, the control of type approval and mandatory specifications, the allocation of frequencies and surveillance of usage conditions are carried out by a body independent of the telecommunications organizations. They shall inform the Commission of the measures taken or draft measures introduced to that end no later than 31 December 1990. Article 8 Member States shall ensure that as soon as the relevant special or exclusive rights have been withdrawn, telecommunications organizations make it possible for customers bound to them by a contract with more than one year to run for the supply of telecommunications services which was subject to such a right at the time it was concluded to terminate the contract at six months' notice. Article 9 Member States shall communicate to the Commission the necessary information to allow it to draw up, for a period of three years, at the end of each year, an overall report on the application of this Directive. The Commission shall transmit this report to the Member States, the Council, the European Parliament and the Economic and Social Committee. Article 10 In 1992, the Commission will carry out an overall assessment of the situation in the telecommunications sector in relation to the aims of this Directive. In 1994, the Commission shall assess the effects of the measures referred to in Article 3 in order to see whether any amendments need to be made to the provisions of that Article, particularly in the light of technological evolution and the development of trade within the Community. Article 11 This Directive is addressed to the Member States.

31990L0396

1990

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 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 Member States are responsible for ensuring the health and safety on their territory of their people and, where appropriate, of domestic animals and goods in relation to the hazards arising out of the use of appliances burning gaseous fuels; Whereas, in certain Member States, mandatory provisions define in particular the safety level required of appliances burning gaseous fuels by specifying design, operating characteristics and inspection procedures; whereas these mandatory provisions do not necessarily lead to different safety levels from one Member State to another but do, by their disparity, hinder trade within the Community; Whereas different conditions as regards types of gas and supply pressures are in force in the Member States; whereas these conditions are not harmonized because each Member State's energy supply and distribution situation is peculiar to it; Whereas paragraphs 65 and 68 of the White Paper on the completion of the internal market, approved by the European Council in June 1985, provide for a new approach to legislative harmonization; Whereas Community law provides - by way of derogation from one of the fundamental rules of the Community, namely the free movement of goods - that obstacles to movement within the Community resulting from disparities in national legislation relating to the marketing of products must be accepted in so far as such obstacles can be recognized as being necessary to satisfy mandatory requirements; whereas, therefore, the harmonization of legislation in the present case must be limited to the provisions necessary to satisfy both the mandatory and essential requirements regarding safety, health and energy conservation in relation to gas appliances; whereas these requirements must replace the national provisions in this matter because they are essential requirements; Whereas the maintenance or improvement of the level of safety attained in Member States constitutes one of the essential aims of this Directive and of safety as defined by the essential requirements; Whereas the essential safety and health requirements must be observed in order to ensure that appliances burning gaseous fuels are safe; whereas energy conservation is considered essential; whereas these requirements must be applied with discernment to take account of the state of the art at the time of construction; Whereas this Directive therefore contains only essential requirements; whereas, to facilitate proof of conformity with the essential requirements, it is necessary to have harmonized standards at European level in particular as to the construction, operation and installation of appliances burning gaseous fuels so that products complying with them may be assumed to conform to the essential requirements; whereas these standards, harmonized at European level, are drawn up by private bodies and must remain non-mandatory texts; whereas for that purpose 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 for cooperation between the Commission and those two bodies signed on 13 November 1984; whereas, for the purposes of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted by one or both of those bodies upon a remit from 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), as last amended by Directive 88/182/EEC (5), and the abovementioned general guidelines; Whereas, pending the adoption of harmonized standards within the meaning of this Directive, conformity with the essential requirements and the free movement of appliances burning gaseous fuels should be facilitated by the acceptance, at Community level, of products conforming to the national standards whose conformity with the essential requirements has been confirmed by a Community checking procedure; Whereas a check on compliance with the relevant technical requirements is necessary in order to provide effective protection for users and third parties; whereas the existing certification procedures differ from one Member State to another; whereas, in order to avoid multiple inspections, which are in effect barriers to the free movement of appliances burning gaseous fuels, arrangements should be made for the mutual recognition of certification procedures by the Member States; whereas, in order to facilitate mutual recognition of certification procedures, harmonized Community procedures should be set up and the criteria for appointing the bodies responsible for carrying out these procedures should be harmonized; Whereas the Member States' responsibility on their territory for safety, health and energy conservation covered by the essential requirements must be recognized in a safeguard clause providing for an adequate Community procedure; Whereas the addressees of any decision taken under this Directive must be informed of the reasons for such a decision and the legal remedies available to them; Whereas the Council adopted, on 17 September 1984, a framework Directive on gas appliances (84/530/EEC) (6), as last amended by Directive 86/312/EEC (7), and a separate Directive on gas water heaters (84/531/EEC) (8), as last amended by Directive 88/665/EEC (9); whereas those Directives cover the same area as this Directive and should therefore be repealed; Whereas the measures aimed at the gradual establishment of the internal market must be adopted by 31 December 1992; whereas the internal market consists of an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured, CHAPTER I Scope, placing on the market and free movement Article 1 1. This Directive shall apply to: - appliances burning gaseous fuels used for cooking, heating, hot water production, refrigeration, lighting or washing and having, where applicable, a normal water temperature not exceeding 105 gC, hereinafter referred to as 'appliances'. Forced draught burners and heating bodies to be equipped with such burners will also be considered as appliances, - safety devices, controlling devices or regulating decives and sub-assemblies, other than forced draught burners and heating bodies to be equipped with such burners separately marketed for trade use and designed to be incorporated into an appliance burning gaseous fuel or assembled to constitute such an appliance, hereinafter referred to as 'fittings'. 2. Appliances specifically designed for use in industrial processes carried out on industrial premises are excluded from the scope defined in paragraph 1. 3. For the purposes of this Directive, 'gaseous fuel' means any fuel which is in a gaseous state at a temperature of 15 gC under a pressure of 1 bar. 4. For the purposes of this Directive, an appliance is said to be 'normally used' when it is: - correctly installed and regularly serviced in accordance with the manufacturer's instructions, - used with a normal variation in the gas quality and a normal fluctuation in the supply pressure, and - used in accordance with its intended purpose or in a way which can be reasonably foreseen. Article 2 1. Member States shall take all necessary steps to ensure that the appliances referred to in Article 1 may be placed on the market and put into service only if, when normally used, they do not compromise the safety of persons, domestic animals and property. 2. Member States shall communicate the types of gas and corresponding supply pressures used on their territory to the other Member States and the Commission before 1 January 1991. They shall also communicate all changes in good time. The Commission shall ensure that this information is published in the Official Journal of the European Communities. Article 3 Appliances and fittings as referred to in Article 1 shall satisfy the essential requirements applicable to them set out in Annex I. Article 4 1. Member States may not prohibit, restrict or impede the placing on the market and the putting into service of appliances which satisfy the essential requirements of this Directive. 2. Member States may not prohibit, restrict or impede the placing on the market of fittings as referred to in Article 1 accompanied by a certificate as referred to in Article 8 (4). Article 5 1. Member States shall presume compliance with the essential requirements referred to in Article 3 of appliances and fittings when they conform to: (a) the national standards applicable to them implementing the harmonized standards whose reference numbers have been published in the Official Journal of the European Communities. Member States shall publish the reference numbers of these national standards; (b) the national standards applicable to them referred to in paragraph 2 in so far as, in the areas covered by such standards, no harmonized standards exist. 2. Member States shall communicate to the Commission the texts of their national standards as referred to in paragraph 1 (b) which they regard as complying with the essential requirements referred to in Article 3. The Commission shall forward these national standards to the other Member States. In accordance with the procedure provided for in Article 6 (2), it shall notify the Member States of those national standards which are presumed to conform with the essential requirements referred to in Article 3. Article 6 1. Where a Member State or the Commission considers that the standards referred to in Article 5 (1) do not entirely meet 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 under Directive 83/189/EEC, hereinafter referred to as 'the committee', giving the reasons therefore. The committee shall deliver an opinion without delay. In the light of the committee's opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw those standards from the publications referred to in Article 5 (1). 2. After receipt of the communication referred to in Article 5 (2), the Commission shall consult the committee. Upon receipt of the latter's opinion, the Commission shall, within one month, inform the Member States whether or not the national standard(s) in question are to enjoy the presumption of conformity; if they are, the Member States shall publish the reference numbers of those standards. The Commission shall also publish them in the Official Journal of the European Communities. Article 7 1. Where a Member State finds that normally used appliances bearing the EC mark might compromise the safety of persons, domestic animals or property, it shall take all appropriate measures to withdraw those appliances from the market and prohibit or restrict their being placed on the market. The Member State concerned shall immediately inform the Commission of any such measure, indicating the reasons for its decision and, in particular, whether non-compliance is due to: (a) failure to meet the essential requirements referred to in Article 3, where the appliance does not correspond to the standards referred to in Article 5 (1); (b) incorrect application of the standards referred to in Article 5 (1); (c) shortcomings in the standards referred to in Article 5 (1) themselves. 2. The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that any measure as referred to in paragraph 1 is justified, it shall immediately so inform the Member State that took the measure and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission, after consulting the parties concerned, shall bring the matter before the committee within two months if the Member State which has taken the measures intends to maintain them, and shall initiate the procedures referred to in Article 6. 3. Where an appliance which does not comply bears the EC mark, 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 the procedures. CHAPTER II Means of certification of conformity Article 8 1. The means of certification of conformity of series-manufactured appliances shall be: (a) the EC type-examination as referred to in section 1 of Annex II, and (b) prior to their being placed on the market, at the choice of the manufacturer: - the EC declaration of conformity to type referred to in section 2 of Annex II, or - the EC declaration of conformity to type (guarantee of production quality) referred to in section 3 of Annex II, or - the EC declaration of conformity to type (guarantee of product quality) referred to in section 4 of Annex II, or - EC verification as referred to in section 5 of Annex II. 2. In the case of production of an appliance as a single unit or in small quantities, EC verification by single unit, as referred to in section 6 of Annex II, may be chosen by the manufacturer. 3. After completion of the procedures referred to in paragraphs 1 (b) and 2, the EC mark of conformity shall be affixed to conforming appliances in accordance with Article 10. 4. The procedures referred to in paragraph 1 shall be applied in respect of fittings as referred to in Article 1 with the exception of the affixing of the EC mark of conformity and, where appropriate, the drawing-up of the declaration of conformity. A certificate shall be issued declaring the conformity of the fittings with the provisions of this Directive which apply to them and stating their characteristics and how they must be incorporated into an appliance or assembled to assist compliance with the essential requirements applicable to finished appliances. The certificate shall be supplied with the fitting. 5. Where the appliances are also subject to other Community Directives: - their compliance with the essential requirements of this Directive shall be verified in accordance with the procedures laid down in paragraphs 1 and 2, and - it shall be ensured that they also comply with the essential requirements of the other Directives in accordance with the procedures laid down in those Directives. The affixing of the EC mark as referred to in paragraph 3 shall certify that the provisions of all the applicable Directives have been complied with. 6. Records and correspondence relating to the means of certification of conformity shall be drawn up in the official language(s) of the Member State where the body responsible for carrying out these procedures is established or in a language accepted by it. Article 9 1. Each Member State shall notify the Commission and the other Member States of the bodies, hereinafter called the 'notified bodies', responsible for carrying out the procedures referred to in Article 8. The Commission shall publish for information purposes in the Official Journal of the European Communities a list of the notified bodies with their identification symbols and shall ensure that the list is kept up to date. 2. Member States shall apply the criteria set out in Annex V for assessing the bodies to be notified. Bodies which satisfy the assessment criteria laid down in the applicable harmonized standards shall be presumed to satisfy the criteria set out in that Annex. 3. A Member State which has notified a body must withdraw approval if it finds that the body no longer meets the criteria referred to in paragraph 2. It shall immediately inform the Commission and the other Member States accordingly. CHAPTER III EC mark of conformity Article 10 1. The EC mark of conformity and the inscriptions set out in Annex III shall be affixed in a visible, easily legible and indelible form to the appliance or to a data plate attached to it. The data plate shall be so designed that it cannot be re-used. 2. The affixing to appliances of marks which are likely to be confused with the EC mark shall be prohibited. Article 11 Where it is established that the EC mark has been wrongly Where it is established that the EC mark has been wrongly affixed to appliances or that certification for fittings has been wrongly attributed because: - the appliances or the fittings do not conform to the appliance or fitting as referred to in the EC type-examination certificate, - the appliances or the fittings conform to the appliance or fitting as referred to in the EC type-examination certificate but do not meet the essential requirements applicable to them, - the manufacturer has failed to fulfil his obligations as specified in Annex II, the notified body shall withdraw the right to affix the EC mark or to issue the certificate and shall so inform the other notified bodies and report to the Member State concerned. CHAPTER IV Final provisions Article 12 Any decision taken pursuant to this Directive which includes restriction on the placing on the market and/or putting into service of an appliance shall state the precise grounds on which it is based. It shall be notified without delay to the party concerned, who shall at the same time be informed of the legal remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject. Article 13 Directives 84/530/EEC and 84/531/EEC are hereby repealed. Article 14 1. Before 1 July 1991, Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall inform the Commission thereof. They shall apply such provisions from 1 January 1992. 2. However, in derogation from Article 2, Member States may, during the period up to 31 December 1995 and without prejudice to Articles 30 to 36 of the Treaty, permit the placing on the market and/or the putting into service of appliances and fittings which comply with the regulations in force in the Member States before 1 January 1992. 3. 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 15 This Directive is addressed to the Member States.

31990L0377

1990

Council Directive 90/377/EEC of 29 June 1990 concerning a Community procedure to improve the transparency of gas and electricity prices charged to industrial end-users Having regard to the Treaty establishing the European Economic Community, and in particular Article 213 thereof, Having regard to the Commission's proposal (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas energy price transparency, to the extent that it reinforces the conditions ensuring that competition is not distorted in the common market, is essential to the achievement and smooth functioning of the internal energy market; Whereas transparency can help to obviate discrimination against users by increasing their freedom to choose between different energy sources and different suppliers; Whereas, at present, the degree of transparency varies from one energy source and one Community country or region to another, thus calling into question the achievement of an internal energy market; Whereas, however, the price paid by industry in the Community for the energy which it uses is one of the factors which influence its competitiveness and should therefore remain confidential; Whereas the system of standard consumers used by the Statistical Office of the European Communities (SOEC) in its price publications and the system of market prices due to be introduced for major industrial electricity users will ensure that transparency is not an obstacle to confidentiality; Whereas it is necessary to extend the consumer categories used by the SOEC up to the limits at which the consumers remain representative; Whereas in this way end-users price transparency would be achieved without endangering the necessary confidentiality of contracts; whereas in order to respect confidentiality there must be at least three consumers in a given consumption category for a price to be published; Whereas this information which concerns gas and electricity consumed by industry for energy end-users, will also enable comparisons to be drawn with other energy sources (oil, coal, fossil and renewable energy sources) and other consumers; Whereas undertakings which supply gas and electricity as well as industrial gas and electricity consumers remain, independently of the application of this Directive, subject to the Treaty's competition rules and whereas consequently the Commission can require communication of prices and conditions of sale; Whereas knowledge of the price systems in force forms part of price transparency; Whereas knowledge of the breakdown of consumers by category and their respective market shares also forms part of price transparency; Whereas the communication to the SOEC of prices and conditions of sale to consumers and price systems in operation as well as the breakdown of consumers by consumption category should inform the Commission sufficiently for it to decide, as necessary, on apropriate action or proposals in the light of the situation of the internal energy market; Whereas the data supplied to the SOEC will be more reliable if the undertakings themselves compile these data; Whereas familiarity with the taxation and parafiscal charges existing in each Member State is important to ensure price transparency; Whereas it must be possible to check the reliability of the data supplied to the SOEC; Whereas the achievement of transparency presupposes the publication and circulation of prices and price systems as widely as possible among consumers; Whereas to implement energy price transparency the system should be based on the proven expertise and methods developed and applied by the SOEC regarding the processing, checking and publication of data; Whereas, with the prospect of the achievement of the internal market in energy, the system of price transparency should be rendered operational as soon as possible; Whereas the uniform implementation of this Directive can only take place in all the Member States when the natural gas market, in particular with regard to infrastructure, has reached a sufficient level of development, Article 1 Member States shall take the steps necessary to ensure that undertakings which supply gas or electricity to industrial end-users, as defined in Annexes I and II, communicate to the SOEC in the form provided for in Article 3: 1. the prices and terms of sale of gas and electricity to industrial end-users; 2. the price systems in use; 3. the breakdown of consumers and the corresponding volumes by category of consumption to ensure the representativeness of these categories at national level. Article 2 1. The undertakings referred to in Article 1 shall assemble the data provided for in Article 1 (1) and (2), on 1 January and 1 July of each year. These data, drawn up in conformity with the provisions referred to in Article 3, shall be sent to the SOEC and the competent authorities of the Member States within two months. 2. On the basis of the data referred to in paragraph 1, the SOEC shall publish each May and each November, in an appropriate form, the prices of gas and electricity for industrial users in the Member States and the pricing systems used to that end. 3. The information provided for in Article 1 (3) shall be sent every two years to the SOEC and to the Member States' competent authorities. The first communication shall concern the situation as at 1 January 1991. This information shall not be published. Article 3 The implementing provisions concerning the form, content and all other features of the information provided for in Article 1 are set out in Annexes I and II. Article 4 The SOEC shall not disclose data supplied to it pursuant to Article 1 which might, by their nature, be subject to commercial confidentiality. Such confidential statistical data transmitted to the SOEC shall be accessible only to officials of the SOEC and may be used only for statistical purposes. This provision shall not, however, prevent the publication of such data in an aggregated form which does not enable individual commercial transactions to be identified. Article 5 Where the SOEC notes statistically significant anomalies or inconsistencies in data transmitted under this Directive, it may ask the national bodies to allow it to inspect the appropriate disaggregated data as well as the methods of calculation or evaluation upon which the aggregated data are based, in order to assess, or even amend, any information deemed irregular. Article 6 Where appropriate, the Commission shall make the necessary changes to the Annexes to this Directive in the light of specific problems identified. Such changes may, however, cover only the technical features of the Annexes and may not be of a nature such as to alter the general structure of the system. Article 7 In the case of any changes to the Annexes, as referred to in Article 6, the Commission shall be assisted by a committee of an advisory nature composed of the 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, 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 8 Once a year the Commission shall present a summary report on the operation of this Directive to the European Parliament, the Council and the Economic and Social Committee. Article 9 Member States shall adopt the laws, regulations and administrative provisions needed to comply with this Directive no later than 1 July 1991. They shall forthwith inform the Commission thereof. In the case of natural gas, the Directive will not be implemented in a Member State until five years after the introduction of that form of energy on the market in question. The date of introduction of that energy source on a national market is to be explicitly reported to the Commission by the Member State concerned without delay. Article 10 This Directive is addressed to the Member States.

31990L0439

1990

Commission Directive 90/439/EEC of 24 July 1990 amending the Annex to Council Directive 82/471/EEC concern ing certain products used in animal feedingstuff Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (1), as last amended by Commission Directive 89/520/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 the study of two new products belonging to the group of protein products obtained from micro-organisms and the amino acids group has shown that these products fulfill the requirements of Directive 82/471/EEC; whereas the use of these products in animal nutrition should, therefore, be permitted under certain conditions; Whereas the measures provided for in this Directive are in accordanced 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 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 1 not later than 30 June 1991. The shall immediately inform the Commission thereof. The provisions adopted pursuant to the first paragraph shall make express reference to this Directive. Article 3 This Directive is addressed to the Member States.

31990L0415

1990

Council Directive 90/415/EEC of 27 July 1990 amending Annex II to Directive 86/280/EEC on limit values and quality objectives for discharges of certain dangerous substances included in list I of the Annex to Directive 76/464/EEC Having regard to the Treaty establishing the European Economic Community, and in particular Article 130s thereof, Having regard to Council Directive 76/464/EEC of 4 May 1976 on pollution caused by certain dangerous substances discharged into the aquatic environment of the Community (1), and in particular Articles 6 and 12 thereof, Having regard to the proposal from the Commission (2), Having regard to the opinion of the European Parliament (3), Having regard to the opinion of the Economic and Social Committee (4), Whereas, in order to protect the aquatic environment of the Community against pollution by certain dangerous substances, Article 3 of Directive 76/464/EEC introduces a system of prior authorization laying down emission standards for discharges of the substances in List I in the Annex thereto; whereas Article 6 of the said Directive provides that limit values shall be laid down for such emission standards and quality objectives for the aquatic environment affected by discharges of the substances; Whereas Member States are required to apply the limit values except in cases where they may employ quality objectives; Whereas Directive 86/280/EEC (5), as amended by Directive 88/347/EEC (6), will have to be amended and supplemented, on proposals from the Commission, in line with developments in scientific knowledge relating principally to the toxicity, persistence and accumulation of the substances referred to in living oganisms and sediments, or in the event of an improvement in the best technical means available; whereas it is necessary, for that purpose, to provide for additions to the said Directive, relating to measures in respect of other dangerous substances, and for amendments to the content of Annex II; Whereas Article 5 of Directive 86/280/EEC provides that, in the case of certain significant sources of pollution by these substances other than sources subject to Community limit values or national emission standards, specific programmes should be devised to eliminate the pollution; Whereas it is appropriate that small discharges which are subject to the provisions of Article 5 of Directive 86/280/EEC may be exempted from the requirements of Article 3 of Directive 76/464/EEC; Wheras, on the basis of the criteria laid down in Directive 76/464/EEC, 1-2-dichloroethane, trichloroethylene, perchloroethylene and trichlorobenzene should be made subject to the provisions of Directive 86/280/EEC, Article 1 Annex II to Directive 86/280/EEC is hereby amended as set out in the Annex hereto. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within 18 months of its notification (1). They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 3 This Directive is addressed to the Member States.

31990L0492

1990

Commission Directive 90/492/EEC of 5 September 1990 adapting to technical progress for the second time 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), as amended by Commission Directive 89/178/EEC (2), and in particular Article 15 thereof, Whereas, when the abovementioned Directive was adopted, the Commission, at the Council's request, was asked to examine the specific problem of mixtures of gases; Whereas Annex I to Directive 88/379/EEC includes tables fixing concentration limits, expressed as a mass/mass percentage, to be used in applying the conventional method of assessing health hazards in accordance with Article 3 (5); Whereas these concentration limits are not appropriate in the case of preparations marketed in gaseous form; Whereas concentration limits expressed as a volume/volume percentage should therefore be inserted into Annex I; whereas these concentration limits are valid only for gaseous constituents used in preparations in gaseous form; 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 Removal of Technical Barriers to Trade in Dangerous Substances and Preparations, Article 1 Annex I to Directive 88/379/EEC is amended in the manner set out in the Annex hereto. Article 2 Member States shall adopt and publish the provisions necessary to comply with this Directive by 1 June 1991 and shall forthwith inform the Commission thereof. They shall apply the provisions from 8 June 1991 at the latest. Article 3 This Directive is addressed to the Member States.

31990L0487

1990

Council Directive 90/487/EEC of 17 September 1990 amending Directive 79/196/EEC on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres employing certain types of protection Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission, in cooperation with the European Parliament (1), Having regard to the opinion of the Economic and Social Committee (2), Whereas Council Directive 76/117/EEC of 18 December 1975 on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres (3), as last amended by the Act of Accession of Spain and Portugal to the Community has, in particular, set out the inspection procedures which this equipment must satisfy in order to be imported, put on the market and used freely after undergoing the tests and being provided with the mark and marking prescribed; Whereas Article 4 (4) of Directive 76/117/EEC provides that separate Directives shall specify the harmonized standards applicable in all the Member States in respect of such equipment; Whereas Directive 79/196/EEC (4), as last amended by Directive 88/665/EEC (5), achieved the free movement of electrical equipment by applying the types of protection listed in Article 1 thereof, and lists in detail in Annex 1 the relevant harmonized standards; Whereas, in view of the current state of the art, harmonized standards for other types of protection and for specific equipment are available; whereas, in order to achieve the free movement of equipment employing these new types of protection, it is necessary to extend the scope of Directive 79/196/EEC to include those types; whereas it is therefore necessary to amend the said Directive, Article 1 Directive 79/196/EEC is hereby amended as follows: 1. the following is added to Article 1: '- encapsulation ''m" - intrinsically safe electrical systems ''i",'; 2. references to the following European standards are added to Annex I: 1.2.3.4 // // // // // 'EN 50028 // Electrical apparatus for potentially explosive atmospheres: encapsulation ''m" // 1 // February 1987 // EN 50039 // Electrical apparatus for potentially explosive atmospheres: intrinsically safe electrical systems ''i" // 1 // March 1980 // EN 50050 // Electrostatic hand-held spraying equipment // 1 // January 1986 // EN 50053 PART 1 // Hand-held electrostatic paint spray guns with an energy limit of 0,24 mJ and their associated apparatus // 1 // February 1987 (*) // EN 50053 PART 2 // Hand-held electrostatic powder spray guns with an energy limit of 5 mJ and their associated apparatus // 1 // June 1989 (*) // EN 50053 PART 3 // Held-held electrostatic flock spray guns with an energy limit of 0,24 mJ or 5 mJ and their associated apparatus // 1 // June 1989 (*) // // // // (*) Only the paragraphs dealing with the construction of apparatus, provided for in standards EN 50053 parts 1, 2 and 3, shall apply.' Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 1992. They shall forthwith inform the Commission thereof. Member States shall communicate the texts of the provisions of national law which they adopt in the field covered by this Directive to the Commission. Article 3 This Directive is addressed to the Member States.

31990L0486

1990

Council Directive 90/486/EEC of 17 September 1990 amending Directive 84/529/EEC on the approximation of the laws of the Member States relating to electrically operated lifts 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 European and Social Committee (3), Whereas Council Directive 84/529/EEC (4), as amended by Commission Directive 86/312/EEC (5), may be applied, mutatis mutandis, to hydraulically or electro-hydraulically operated lifts; Whereas the standard EN 81-1 on which Directive 84/529/EEC is based has been supplemented since that Directive was published by a second part, EN 81-2, which relates to hydraulic and oil lifts; Whereas the scope of Directive 84/529/EEC should be extended as a matter of urgency since manufacturers face significant technical barriers to intra-Community trade which threaten to distort the market; Whereas measures must be adopted aimed at progressively establishing the internal market over a period expiring on 31 December 1992, Article 1 Directive 84/529/EEC is hereby amended as follows: 1. the title of the Directive is replaced by: 'Council Directive 84/529/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to electrically, hydraulically or oil-electrically operated lifts'; 2. the first recital is replaced by the following: 'Whereas in the Member States the construction and inspection of electrically, hydraulically or oil-electrically operated lifts are subject to mandatory provisions which differ from one Member State to another and consequently hinder trade in such lifts; whereas it is therefore necessary to approximate these provisions;' 3. Article 1 (1) is replaced by the following: '1. This Directive shall apply to permanently installed hoisting appliances electrically, hydraulically or oil-electrically driven serving specific levels, having a car designed for the transport of persons or of persons and goods, suspended by ropes or chains or supported by one or more ramps and moving at least partially between guides which are vertical or inclined at an angle of less than 15° to the vertical, hereinafter referred to as "lifts".'; 4. the following is deleted from the third indent of Article 1 (2): 'passenger, goods or service lifts not driven by an electric motor, appliances actuated by fluids (such as oil and hydraulic lifts),'; 5. in Annex I: (a) section 1 is replaced by the following: '1. The appliances referred to in Article 1 (1) must, with the exception of the sections referred to in section 2, comply with the following standards adopted by the European Committee for Standardization (CEN): - EN 81-1 (edition: December 1985). Safety rules for the construction and installation of lifts and service lifts. Part 1: Electric lifts. - EN 81-2 (edition: November 1987). Safety rules for the construction and installation of lifts and service lifts. Part 2: Hydraulic lifts.'; (b) in section 2, '2. This standard shall apply subject to the following modifications: 2.1. Section 12.4.2.1.' is replaced by: '2. These standards shall apply, subject to the following modifications: 2.1. Section 12.4.2.1 (applies only for standard EN 81-1 - edition: December 1985)'. Article 2 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary in order to comply with this Directive during the six months following its notification (1). They shall forthwith inform the Commission thereof. 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.

31990L0531

1990

Council Directive 90/531/EEC of 17 September 1990 on the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors Having regard to the Treaty establishing in the European Economic Community and in particular the last sentence of Article 57 (2), Article 66, Article 100a and Article 113 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 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; Whereas the European Council has drawn conclusions concerning the need to bring about a single internal market; Whereas restrictions on the free movement of goods and on the freedom to provide services in respect of supply contracts awarded in the water, energy, transport and telecommunications sectors are prohibited by the terms of Articles 30 and 59 of the Treaty; 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; Whereas these objectives also require the coordination of the procurement procedures applied by the entities operating in these sectors; 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), as last amended by Council Directive 89/440/EEC(5), and Council Directive 77/62/EEC of 21 December 1976 coordinating procedures for the award of public supply contracts(6), as last amended by Directive 88/295/EEC(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; 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; 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; Whereas, in the four sectors concerned, the procurement problems to be solved are of a similar nature, so permitting them to be addressed in one instrument; 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; 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; 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 nevertheless are directly exposed to competitive forces in markets to which entry is unrestricted; 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 the 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; 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; 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; 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; Whereas Regulations (EEC) No 3975/87(8) and (EEC) No 3976/87(9), Directive 87/601/EEC(10) and Decision 87/602/EEC(11) 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; 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; Whereas it is appropriate to facilitate compliance with provisions relating to activities not covered by this Directive; 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; Whereas the Community's or the Member States' existing international obligations must not be affected by the rules of this Directive; 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; 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; Whereas, when the contracting entities define by common accord with tenderers the deadlines for receiving tenders, they shall comply with the principle of non-discrimination, and whereas, if there is no such agreement, it is necessary to lay down suitable provisions; 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; Whereas it is appropriate that national provisions for regional development requirements to be taken into consideration in the award of public works contracts should be made to conform to the objectives of the Community and be in keeping with the principles of the Treaty; 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; Whereas, within certain limits, preference should be given to an offer of Community origin where there are equivalent offers of third country origin; Whereas this Directive should not prejudice the position of the Community in any current or future international negotiations; 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; 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; 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; 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; Whereas this Directive should be re-examined in the light of experience; Whereas the opening up of contracts, on 1 January 1993, 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 purposes 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: ENGMS 10-19theo4-6Thomas -is established for the specific purpose of meeting needs in the general interest, not being of a commercial or industrial nature, and -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 major 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.supply and works contracts shall mean contracts for pecuniary interest concluded in writing between one of the contracting entities referred to in Article 2 and a supplier or contractor and which have 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 or of software services. These contracts may in addition cover siting and installation operations. Software services shall be covered by this definition where they are procured by a contracting entity exercising and activity defined in Article 2 (2) (d) and are for use in the operation of a public telecommunications network or are intended to be used in a public telecommunications service as such; (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. Contracts which include the provision of services other than those referred to in (a) and (b) shall be regarded as supply contracts if the total value of supplies, including siting and installation operations necessary for the execution of the contract and of software services within the meaning of subparagraph (a), is greater than the value of the other services covered by the contract; 4.framework agreement shall mean an agreement between one of the contracting entities defined in Article 2 and one or more suppliers or contractors, 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; 5.tenderer shall mean a supplier or contractor who submits a tender and candidate shall mean a person who has sought an invitation to take part in a restricted or negotiated procedure; 6.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 or contractors 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 or contractors of its choice and negotiates the terms of the contract with one or more of them; 7.technical specifications shall mean the technical requirements contained in particular in the tender documents, defining the characteristics of a set of works, material, product or supply, and enabling a piece of work, a material, a product or a supply to be objectively described in a manner such that it fulfils the use for which it is intended by the contracting entity. These technical prescriptions may include quality, performance, safety or dimensions, as well as requirements applicable to the material, product, or supply 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 methods or techniques 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; 8.standard shall mean a technical specification approved by a recognized standardizing body for repeated and continuous application, compliance with which is in principle not compulsory; 9.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); 10.common technical specification shall mean a technical specification drawn up in accordance with a procedure recognized by the Member States which a view to uniform application in all Member States and published in the Official Journal of the European Communities; 11.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(12). European technical approval shall be issued by an approval body designated for this purpose by the Member State; 12.European specification shall mean a common technical specification, a European technical approval or a national standard implementing a European standard; 13.public telecommunications network shall mean the public telecommunications infrastructure which enables 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 specifications which form part of the public telecommunications network and are necessary for access to, and efficient communication through, that public network; 14.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. 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)or, 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 tele- communications 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 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 conditions 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 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 32. 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 the exploitation for 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 and exclusively with a view to the objectives mentioned in Article 36 of the Treaty. ENGMS 20-31theo7-9Thomas 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 and works contracts, in particular as regards the information that 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 32, 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 37, paragraphs 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 doing so, 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 32 (4) to (7). 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 36. Article 4 1. When awarding supply or works contracts, 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 or contractors. 3. In the context of provision of technical specifications to interested suppliers and contractors, of qualification and selection of suppliers or contractors 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. The provisions of this Directive shall not limit the right of suppliers or contractors 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 the meaning of Article 1 (3) 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 15 (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 15 (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 which the contracting entities award 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 awarded on behalf of the entities which exercise an activity referred to in Article 2 (2) (a) (i) and which: (a)are connected with 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. The provisions of this Directive shall not apply to contracts awarded for purposes of re-sale 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 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 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 they regard as covered by the exclusion referred to in 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 specified in Annexes II, III, IV and 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 the Member State, 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 contracts governed by different procedural rules and awarded: 1.pursuant to an international agreement concluded in conformity with the Treaty beween a Member State and one or more third countries and covering supplies or works 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), as last amended by Decision 77/63/EEC(14), 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 31; 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 12 1. This Directive shall apply to contracts whose estimated value, net of VAT, is not less than: (a)ECU 400 000 in the case of supply 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 contracts awarded by entities exercising an activity defined in Article 2 (2) (d); (c)ECU 5 million in the case of works contracts. 2. 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. 3. Where a proposed supply 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. 4. In the case of a procurement of supplies over a given period by means of a series of contracts to be awarded to one or more suppliers or of contracts which are to be renewed, the contract value shall be calculated on the basis of: (a)the total value of contracts which had similar characteristics awarded over the previous fiscal year or 12 months, adjusted where possible for anticipated changes in quantity or value over the subsequent 12 months; (b)or 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. 5. 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. 6. 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 building and engineering activities taken as a whole that are intended to fulfil an economic function by themselves. In particular, where a supply or work 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 whose estimated value net of VAT is less then ECU 1 million, provided that the aggregate value of those lots does not exceed 20 % of the overall value of the lots. 7. 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 contract which they make available to the contractor. 8. The value of supplies which are not necessary for the execution of a particular works contract may not be added to that of the contract with the result of avoiding application of this Directive to the procurement of those supplies. 9. Contracting entities may not circumvent this Directive by splitting contracts or using special methods of calculating the value of contracts. TITLE II Technical specifications and standards Article 13 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 complement European specifications or other standards. In doing so, they shall prefer specifications that 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, or specific origin or production shall be prohibited; however, such an indication accompanied by the words or equivalent shall be authorized where the subject of the contract cannot otherwise be described by specifications ENGMS 32-46theo10-13Thomas 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(15), or of Council Decision 87/95/EEC of 22 December 1986 on standardization in the field of information technology and telecommunications(16); (c)in the context of adapting existing practice to take account of European specifications, use of these 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 a clearly defined and recorded strategy with a view to a change-over 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 16 (1) (a) shall indicate any recourse to the derogations referred to in paragraph 6. 8. This Article shall be without prejudice to compulsory technical rules insofar as these are compatible with Community law. Article 14 1. Contracting entities shall make available on demand to suppliers or contractors interested in obtaining a contract the technical specifications regularly referred to in their supply or works contracts or the technical specifications which they intend to apply to contracts covered by periodic information notices within the meaning of Article 17. 2. Where such technical specifications are based on documents available to interested suppliers or contractors, a reference to those documents shall be sufficient. TITLE III Procedures for the award of contracts Article 15 1. Contracting entities may choose any of the procedures described in Article 1 (6), provided, subject to paragraph 2, a call for competition has been made in accordance with Article 16. 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; (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 or contractor; (d)insofar 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 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 executing the original contract: -when such additional works cannot be technically or economically separated from the main contract without great inconvenience to the contracting entities, -or when such additional works, 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 12; (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 either from a supplier definitively winding up his business activities or from the receivers or liquidators of a bankruptcy, an arrangement with creditors or a similar procedure under national laws or regulations. Article 16 1. A 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 or works 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. 3. 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 procedure shall be selected from the qualified candidates in accordance with such a system. 4. The notices referred to in this Article shall be published in the Official Journal of the European Communities. Article 17 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 12, is equal to or greater than ECU 750 000, and which they intend to award over the following 12 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 12 (1). 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 16 (1) (b), it must have been published not more than 12 months prior to the date on which the invitation referred to in Article 16 (2) (c) is sent. Moreover, the contracting entity shall meet the deadlines laid down in Article 20 (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 it is clearly stated that such notices are additional notices. Article 18 1. Contracting entities which have awarded a contract 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 32, the results of the awarding procedure by means of a notice drawn up in accordance with Annex XV. 2. Information provided under Section I of Annex XV shall be published in the Official Journal of the European Communities. In this connection the Commission shall respect any sensitive commercial aspects the contracting entities may point out when forwarding this information in connection with points 6 and 9 of Annex XV. 3. Information provided under Section II of Annex XV must not be published except, in aggregated form, for statistical purposes. Article 19 1. The contracting entities must be able to supply proof of the date of dispatch of the notices referred to in Articles 15 to 18. 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 16 (1) (a) within five days in response to a request by the contracting entity and provided 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 ore more notices shall reproduce the model notice or notices on which the published notice or notices 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 in respect of which a notice is published in the Official Journal of the European Communities pursuant to Article 16 (1) 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 20 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 17 (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 16 (1) (a) or in response to an invitation from a contracting entity in accordance with Article 16 (2) (c), shall, as a general rule, be at least five weeks from the date of dispatch of the notice and shall in any case not be less than the time limit for publication laid down in Article 19 (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 22 (3). Article 21 In the contract documents, the contracting entity 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 contractor's responsibility. Article 22 1. Provided they have been requested in good time, the contract documents and supporting documents must be sent to the suppliers or contractors by the contracting entities as a general rule within six days of receipt of the application. 2. Provided 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 in fixing the appropriate time limits. 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, telefax, telephone or any electronic means, they must be confirmed by letter dispatched before the expiry of the time limit referred to in Article 20 (1) or of the time limit set by contracting entities pursuant to Article 20 (2). Article 23 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 are to be executed and which shall be applicable to the works carried out 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 is to be carried out. This shall be without prejudice to the application of the provisions of Article 27 (5) concerning the examination of abnormally low tenders. TITLE IV Qualification, selection and award Article 24 1. Contracting entities which so wish may establish and operate a system of qualification of suppliers or contractors. 2. The system, which may involve different qualification stages, shall operate on the basis of objective rules and criteria to be established by the contracting entity. The contracting entity shall use European standards as a reference where they are appropriate. The rules and criteria may be updated as required. 3. The rules and criteria for qualification shall be made available on request to interested suppliers or contractors. The updating of these criteria and rules shall be communicated to the interested suppliers and contractors. Where a contracting entity considers that the qualification or certification system of certain third entities or bodies meet its requirements, it shall communicate to interested suppliers and contractors 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 or contractors that are not imposed on others, -require tests or proof that duplicate objective evidence already available. ENGMS 47-61theo14-17Thomas 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 or contractors 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 or contractor 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 or contractor 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 25 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 or contractors. 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 26 Groupings of suppliers or contractors 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. Article 27 1. 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 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 any 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 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 not been able to show that the aid in question has been notified to the Commission pursuant to Article 93 (3) of the Treaty or has received the Commission's approval. Contracting entities which reject a tender under these circumstances shall inform the Commission thereof. Article 28 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 whose aim is to give preference to certain tenderers provided 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 Treaty and with the Community's international obligations. Article 29 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(17), as last amended by Regulation (EEC) No 3860/87(18), exceeds 50 % of the total value of the products constituting the tender. For the purposes of this Article, software used in the equipment of telecommunication networks 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 27, preference shall be given to the tenders which may not be rejected pursuant to paragraph 2. The prices of 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 purposes, in this Article, of determining the proportion referred to in paragraph 2 of products originating in third countries, 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. 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. TITLE V Final provisions Article 30 1. The value in national currencies of the thresholds specified in Article 12 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 software service contracts are concerned and from the date provided for in Directive 71/305/EEC as far as the threshold 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 October 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 31 1. The Commission shall be assisted, as regards procurement by the contracting entities exercising an activity defined 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 32 (2) relating to notices and statistical accounts. Article 32 1. Annexes I to X shall be revised in accordance with the procedure laid down in paragraphs 3 to 7 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 16, 17 and 18 and of the statistical reports provided for in Article 34 shall be established, for the purposes of simplification, in accordance with the procedure laid down in paragraphs 3 to 7. 3. The revised Annexes and the conditions referred to in paragraphs 1 and 2 shall be published in the Official Journal of the European Communities. 4. 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 31 of this Directive. 5. 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. 6. The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask for its position to be recorded in the minutes. 7. 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 33 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 or suppliers and award of contracts; (b)recourse to derogations from the use of European specifications in accordance with Article 13 (6); (c)use of procedures without prior call for competition in accordance with Article 15 (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 it so requests. Article 34 1. The Member States shall ensure that each year, in accordance with the arrangements to be laid down under the procedure provided for in Article 32 (3) to (7), the Commission receives 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 12 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 32 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 35 1. 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 (*) 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. (*)OJ No L 297, 29. 10. 1990, p. 1. 2. Article 3 (4) and (5) of Directive 71/305/EEC is hereby replaced by the following: 4. This Directive shall not apply to 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 water, energy, transport and telecommunications sectors (*) or fulfilling the conditions in Article 6 (2) of the said Directive. (*)OJ No L 297, 29. 10. 1990, p. 1. Article 36 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, make further proposals to adapt it, in the light of developments concerning in particular progress in market opening 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 37 1. Member States shall adopt the measures necessary to comply with this Directive by 1 July 1992. They shall forthwith inform the Commission thereof. 2. Member States may stipulate that the measures referred to in paragraph 1 shall apply only from 1 January 1993. Nevertheless, in the case of the Kingdom of Spain, 1 January 1993 shall be replaced by 1 January 1996. As regards the Hellenic Republic and the Portuguese Republic, 1 January 1993 shall be replaced by 1 January 1998. 3. Council recommendation 84/550/EEC of 12 November 1984 concerning the first phase of opening up access to public telecommunications contracts(19) shall cease to have effect as from the date on which this Directive is applied by the Member States. Article 38 Member States shall communicate to the Commission the text of the main provisions of national law, whether laws, regulations or administrative provisions, which they adopt in the field governed by this Directive. Article 39 This Directive is addressed to the Member States.

31990L0488

1990

Council Directive 90/488/EEC of 17 September 1990 amending Directive 87/404/EEC on the harmonization of the laws of the Member States relating to simple pressure vessels 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 87/404/EEC (4) provides for the complete harmonization of the standards for simple pressure vessels manufactured in series; Whereas in the absence of harmonized standards Directive 87/404/EEC requires EC-type examination of the vessels in question; whereas those standards will not be available by the date of application of the Directive; Whereas Directive 87/404/EEC has not provided for a transitional period during which it would be permitted to market stocks of vessels manufactured in accordance with national rules still applicable before that Directive takes effect; Whereas manufacturers must have the time needed to apply the EC-type examination procedure and it is necessary to set a transitional period to allow vessels in stock to be marketed, Article 1 The following is hereby added to Article 18 (1) of Directive 87/404/EEC: Member States shall, for the period up to 1 July 1992, permit the placing on the market and/or in service of vessels conforming to the rules in force in their territories before the date of application of this Directive.' Article 2 Member States shall adopt the provisions necessary to comply with this Directive by 1 July 1991. They shall forthwith inform the Commission thereof, Article 3 This Directive is addressed to the Member States.

31990L0496

1990

Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs 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 that measures should be adopted with a view to the progressive establishment of the internal market by 31 December 1992; whereas the internal market is an area without internal frontiers in which freedom of movement is ensured for goods, persons, services and capital; Whereas there is growing public interest in the relationship between diet and health and in the choice of an appropriate diet to suit individual needs; 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 the European programme against cancer, considered the improvement of nutrition to be a priority; Whereas knowledge of the basic principles of nutrition and appropriate nutrition labelling of foodstuffs would contribute significantly towards enabling the consumer to make this choice; Whereas the provision of nutrition labelling should assist action in the area of nutrition education for the public; Whereas, for the benefit of the consumer on the one hand, and to avoid any possible technical barriers to trade on the other, nutrition labelling should be presented in a standardized form applying throughout the Community; Whereas foodstuffs bearing nutrition labelling should conform to the rules laid down in this Directive; Whereas all other forms of nutrition labelling should be prohibited but foodstuffs bearing no nutrition labelling should be able to circulate freely; Whereas, to appeal to the average consumer and to serve the purpose for which it is introduced, and given the current low level of knowledge on the subject of nutrition, the information provided should be simple and easily understood; Whereas application of this Directive for a certain length of time will enable valuable experience on the subject to be gained and consumer reaction to the way in which nutrition information is presented to be evaluated thus enabling the Commission to review the rules and propose any appropriate amendments; Whereas in order to encourage interested parties, especially small and medium-sized undertakings, to provide nutrition labelling for as many products as possible, measures to make information more complete and more balanced should be introduced gradually; Whereas the rules laid down in this Directive should also take into account the Codex Altimentarius guidelines on nutrition labelling; Whereas general labelling provisions and definitions are contained in 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 (4), as last amended by Directive 89/395/EEC (5); whereas this Directive can therefore be confined to those provisions pertaining to nutrition labelling, Article 1 1. This Directive concerns nutrition labelling of foodstuffs to be delivered as such to the ultimate consumer. It shall also apply to foodstuffs intended for supply to restaurants, hospitals, canteens and other similar mass caterers (hereinafter referred to as 'mass caterers'). 2. This Directive shall not apply to: - natural mineral waters or other waters intended for human consumption, - diet integrators/food supplements. 3. This Directive shall apply without prejudice to the labelling provisions of Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (3) and specific Directives as referred to in Article 4 of that Directive. 4. For the purposes of this Directive: (a) 'nutrition labelling' means any information appearing on labelling and relating to: (i) energy value; (ii) the following nutrients: - protein, - carbohydrate, - fat, - fibre, - sodium, - vitamins and minerals listed in the Annex and present in significant amounts as defined in that Annex. Changes to the list of vitamins, minerals and their recommended daily allowances shall be adopted in accordance with the procedure laid down in Article 10; (b) 'nutrition claim' means any representation and any advertising message which states, suggests or implies that a foodstuff has particular nutrition properties due to the energy (calorific value) it - provides, - provides at a reduced or increased rate or - does not provide, and/or due to the nutrients it - contains, - contains in reduced or increased proportions or - does not contain. A reference to qualities or quantities of a nutrient does not constitute a nutrition claim in so far as it is required by legislation. In accordance with the procedure laid down in Article 10, it may be decided in certain cases whether the conditions described in this point are satisfied; (c) 'protein' means the protein content calculated using the formula: protein = total Kjeldahl nitrogen × 6,25; (d) 'carbohydrate' means any carbohydrate which is metabolized in man, and includes polyols; (e) 'sugars' means all monosaccharides and disaccharides present in food, but excludes polyols; (f) 'fat' means total lipids, and includes phospholipids; (g) 'saturates' means fatty acids without double bond; (h) 'mono-unsaturates' means fatty acids with one cis double bond; (i) 'polyunsaturates' means fatty acids with cis, cis-methylene interrupted double bonds; (j) 'fibre' means the material to be defined in accordance with the procedure laid down in Article 10 and measured by the method of analysis to be determined in accordance with that procedure; (k) 'average value' means the value which best represents the amount of the nutrient which a given food contains, and reflects allowances for seasonal variability, patterns of consumption and other factors which may cause the actual value to vary. Article 2 1. Subject to paragraph 2, nutrition labelling shall be optional. 2. Where a nutrition claim appears on labelling, in presentation or in advertising, with the exclusion of generic advertising, nutrition labelling shall be compulsory. Article 3 The only nutrition claims permitted shall be those relating to energy, to the nutrients listed in Article 1 (4) (a) (ii) and to substances which belong to or which are components of a category of those nutrients. Provisions restricting or prohibiting nutrition claims within the meaning of this Article may be adopted by the procedure laid down in Article 10. Article 4 1. Where nutrition labelling is provided, the information to be given shall consist of either group 1 or group 2 in the following order: Group 1 (a) energy value; (b) the amounts of protein, carbohydrate and fat. Group 2 (a) energy value; (b) the amounts of protein, carbohydrate, sugars, fat, saturates, fibre and sodium. 2. Where a nutrition claim is made for sugars, saturates, fibre or sodium, the information to be given shall consist of group 2. 3. Nutrition labelling may also include the amounts of one or more of the following: - starch, - polyols, - mono-unsaturates, - polyunsaturates, - cholesterol, - any of the minerals or vitamins listed in the Annex and present in significant amounts as defined in that Annex. 4. The declaration of substances which belong to or are components of one of the categories of nutrients referred to in paragraphs 1 and 3 shall be compulsory where a nutrition claim is made. In addition, where the amount of polyunsaturates and/or mono-unsaturates and/or the cholesterol rate is given, the amount of saturates shall also be given, the declaration of the latter not constituting - in this case - a nutrition claim within the meaning of paragraph 2. Article 5 1. The energy value to be declared shall be calculated using the following conversion factors: - carbohydrate (except polyols) 4 kcal/g - 17 kJ/g - polyols 2,4 kcal/g - 10 kJ/g - protein 4 kcal/g - 17 kJ/g - fat 9 kcal/g - 37 kJ/g - alcohol (ethanol) 7 kcal/g - 29 kJ/g - organic acid 3 kcal/g - 13 kJ/g 2. Provisions concerning the following points shall be adopted in accordance with the procedure laid down in Article 10: - amendments to the conversion factors mentioned in paragraph 1, - the addition to the list in paragraph 1 of substances which belong to or are components of one of the categories of nutrients referred to in that paragraph and their conversion factors in order to calculate more precisely the energy value of foodstuffs. Article 6 1. The declaration of the energy value and of the proportion of nutrients or their components shall be numerical. The units to be used are the following: 1.2 // - energy - kJ and kcal // // - protein // // - carbohydrate // // - fat // grams (g) // - fibre // // - sodium // // - cholesterol // milligrams (mg) // - vitamins and minerals // the units specified in the Annex 2. Information shall be expressed per 100 g or per 100 ml. In addition, this information may be given per serving as quantified on the label or per portion, provided that the number of portions contained in the package is stated. 3. In accordance with the procedure laid down in Article 10 it may be decided that the information in paragraphs 1 and 2 may also be given in graphical form according to formats to be determined. 4. The amounts mentioned shall be those of the food as sold. Where appropriate, this information may relate to the foodstuff after preparation, provided that sufficiently detailed preparation instructions are given and the information relates to the food as prepared for consumption. 5. (a) Information on vitamins and minerals must also be expressed as a percentage of the recommended daily allowance (RDA) given in the Annex for the amounts as specified in paragraph 2. (b) The percentage of the recommended daily allowance (RDA) for vitamins and minerals may also be given in graphical form. Rules for implementing this subparagraph may be adopted in accordance with the procedure laid down in Article 10. 6. Where sugars and/or polyols and/or starch are declared, this declaration shall immediately follow the declaration of the carbohydrate content in the following manner: 1.2 // - carbohydrate // g // of which: // // - sugars // g // - polyols // g // - starch // g 7. Where the amount and/or type of fatty acid and/or the cholesterol rate is declared, this declaration shall immediately follow the declaration of total fats in the following manner: 1.2 // - fat // g // of which: // // - saturates // g // - mono-unsaturates // g // - polyunsaturates // g // - cholesterol // mg 8. The declared values shall, according to the individual case, be average values based on: (a) the manufacturer's analysis of the food; (b) a calculation from the known or actual average values of the ingredients used; (c) a calculation from generally established and accepted data. The rules for implementing the first paragraph with regard in particular to the differences between the declared values and those established in the course of official checks shall be decided upon in accordance with the procedure laid down in Article 10. Article 7 1. The information covered by this Directive must be presented together in one place in tabular form, with the numbers aligned if space permits. Where space does not permit, the information shall be presented in linear form. It shall be printed in legible and indelible characters in a conspicuous place. 2. Member States shall ensure that the information covered by this Directive appears in a language easily understood by purchasers, unless other measures have been taken to ensure that the purchaser is informed. This provision shall not prevent such information from being indicated in more than one language. 3. Member States shall refrain from laying down requirements more detailed than those already contained in this Directive concerning nutrition labelling. Article 8 In the case of non-prepackaged foodstuffs put up for sale to the ultimate consumer or to mass caterers and foodstuffs packed at the point of sale at the request of the purchaser or prepackaged with a view to immediate sale, the extent of the information referred to in Article 4 and the manner of its communication may be determined by national provisions until the eventual adoption of Community measures in accordance with the procedure laid down in Article 10. Article 9 Any measures likely to have an effect on public health shall be adopted after consultation of the Scientific Committee for Food set up by Decision 74/234/EEC (1). Article 10 1. Where the procedure laid down in this Article is to be followed, the matter shall be referred to the Standing Committee for Foodstuffs set up by Decision 69/414/EEC (2) (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 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) 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. (c) If, on 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 11 1. Member States shall take the measures necessary to comply with this Directive and shall forthwith inform the Commission thereof. Those measures shall be applied in such a way as to: - permit trade in products complying with this Directive by 1 April 1992, - prohibit trade in products which do not comply with this Directive with effect from 1 October 1993. 2. Until . . . . (five years following notification of this Directive), the declaration in nutrition labelling, either on a voluntary basis or following a nutrition claim, of one or more of the following nutrients; sugars, saturates, fibre, sodium, shall not trigger the obligation set out in Article 4 (1) and (2) to declare all these nutrients. 3. The Commission shall, by . . . . (eight years after notification of this Directive), submit to the European Parliament and the Council a report on the application of this Directive. At the same time, it shall submit to the Council any appropriate proposals for amendment. Article 12 This Directive is addressed to the Member States.

31990L0490

1990

Eight Commission Directive 90/490/EEC of 25 September 1990 amending certain Annexes to Council Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant products 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 Member States of organisms harmful to plants or plant products (1), as last amended by Commission Directive 90/168/EEC (2), and in particular Article 13, second paragraph, fourth indent thereof, Whereas developments in scientific and technical knowledge have shown that protection of Community forests should be improved in cases where they are at risk; Whereas it has been determined that Bursaphelenchus xylophilus is a harmful organism not yet present in the Community; whereas it is considered that this pest represents a serious danger to trees grown in, and may be carried upon wood imported into, the Community; whereas appropriate measures to combat this pest should be included within Directive 77/93/EEC; Whereas appropriate measures should be taken to protect the Community against the vectors of Bursaphelenchus xylophilus, especially non-European Monochamus spp., where these organisms do not occur; Whereas 'kiln-drying' to below 20 % moisture content expressed as a percentage of dry matter at time of manufacture, achieved through an appropriate time/temperature schedule, and is so identified, is an effective measure to protect the Community against the introduction of certain organisms affecting wood of conifers; Whereas therefore the relevant Annexes of Directive 77/93/EEC should be amended accordingly; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Directive 77/93/EEC is hereby amended as indicated in the Annex to this Directive. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive by 1 January 1991 at the latest. These shall make express reference to this Directive. Member States shall immediately inform the Commission of all laws, regulations and administrative provisions adopted in implementation of this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive is addressed to the Member States.

31990L0506

1990

Ninth Commission Directive 90/506/EEC of 26 September 1990 amending annex IV to Council Directive 77/93/CEE on protective measures against the introduction into the member states of organisms harmful to plants or plant products 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 Member States of organisms harmful to plants or plant products (1), as last amended by Commission Directive 90/490/EEC (2), and in particular Article 13, second paragraph, fourth indent thereof, Whereas the provisions on protective measures against harmful organisms such as Amauromyza and Liriomyza should be improved, and in particular adapted to the present distribution of such organisms; Whereas therefore the relevant Annex of Directive 77/93/EEC should be amended accordingly; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 In Annex IV, part A to Directive 77/93/EEC, points 33 a and 33 b are replaced by the following: 1.2 // // // '33 a. Plants of Apium graveolens, Brassica, Capsicum annuum, Chrysanthemum, Cucumis, Dendranthema, Dianthus, Gerbera, Gypsophila, Lactuca sativa, Leucanthemum, Lycopersicon esculentum, Solanum melongena, Tanacetum, intended for planting, other than seeds, originating in a Member State or in those third countries where it has been ascertained, in accordance with the procedure laid down in Article 16, that: - amauromyza maculosa, - Liriomyza huidobrensis, - Liriomyza sativae, - Liriomyza trifolii are not known to occur. // Official statement that: - either no signs of any of the relevant harmful organisms have been observed at the place of production on official inspections carried out at least monthly during the three months prior to harvesting, or - immediately prior to export the plants have been inspected and found free from signs of the relevant harmful organisms and have been subjected to an appropriate treatment aimed at eradicating the relevant harmful organisms. // 33 b. Plants of species covered by 33 a for planting, other than seeds, originating in American countries or in any other third country not covered by 33 a. // Official statement that no signs of Amauromyza maculosa, Liriomyza huidobrensis, Liriomyza sativae or Liriomyza trifolii have been observed at the place of production, on official inspections carried out at least 1990, p. 28. // 33 c. Plants of herbaceous species, other than those covered by 33 a, for planting, other than seeds, originating in a Member State where any of the harmful organisms specified in 33 a are known to occur or in American countries or in any other third country not covered by 33 a. // Official statement that: - either no signs of any of the relevant harmful organisms have been observed at the place of production on an official inspection carried out prior to harvesting, or - immediately prior to export the plants have been inspected and found free from signs of the relevant harmful organisms and have been subjected to an appropriate treatment aimed at eradicating the relevant harmful organisms.' Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1991. These provisions shall make express reference to this Directive. Member States shall immediately inform the Commission of all laws, regulations and administrative provisions adopted in implementation of this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive is addressed to the Member States.

31990L0517

1990

Council Directive 90/517/EEC of 9 October 1990 adapting to technical progress for the 11th 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, Having regard to Directive 67/548/EEC (1), as last amended by Directive 79/831/EEC (2), and in particular Articles 19, 20 and 21 thereof, Having regard to the proposal from the Commission, Whereas Denmark has requested a change in the labelling of dichloromethane and notified the Commission accordingly under Article 23 of Directive 67/548/EEC; Whereas the Commission has examined the evidence for the carcinogenicity of dichloromethane, and has consulted the appropriate experts designated by Member States and having special qualifications with respect to carcinogenicity; Whereas this classification reflects a majority of current scientific opinion; Whereas it is recognized that a greater understanding of the mechanisms of action of chemical substances in man and the extrapolation of effects seen in other species to man are under continuous development; whereas in the case of further scientific evidence or change in the criteria for classification relating especially to the carcinogenic or neurotoxicological effects of this substance, the classification will be reviewed in the light of this new information; Whereas the Committee on the Adaptation to Technical Progress of the Directives for the Elimination of Technical Barriers to Trade in Dangerous Substances and Preparations gave an unfavourable opinion on the draft of the measure which was submitted to it by the Commission; Article 1 Annex I (list of dangerous substances) to Directive 67/548/EEC: No 602-004-00-3: The designation, CAS-number, classification and labelling of the substance are replaced by the following: 1.2.3 // // // // Cas No 75-09-2 // // No 602-004-00-3 // // // // // H Cl - C - Cl H // 1.2 // ES: // diclorometano; cloruro de metileno // DA: // dichlormethan; methylenchlorid // DE: // Dichlormethan; Methylenchlorid // EL: // Dichloromethánio; methylenodichlorídio // EN: // dichloromethane; methylene chloride; methylene dichloride // FR: // Dichlorométhane; chlorure de méthylène // IT: // diclorometano; metilene cloruro // NL: // dichloormethaan; methyleenchloride // PT: // diclorometano; cloreto de metileno Xn R: 40 S: 23-24/25-36/37 Article 2 Not later than 7 June 1991 Member States shall adopt and publish the provisions necessary to comply with this Directive and shall forthwith inform the Commission thereof. They shall apply such provisions with effect from 7 December 1991. Article 3 This Directive is addressed to the Member States.